Vol. 50, No. 1. 2015

1 7

15JP1886JPXVI2011

USP BP 13 X

33 38 2 46 20

64 78

10 84

89

95/ 2015 103

The JAPANESE JOURNAL FOR HISTORYOF PHARMACY, Vol. 50, No. 12015

CONTENTS

Plenary Lecture

Ichiro Arai : History of Japanese Kampo Medicines Manufacturers 1

Hiromu Sakurai : History of Inorganic-pharmaceutics in Japan 7

Original

Kiyohisa Yanagisawa : Transition of Psychotropic Drugs in Japanese Pharmacopoeia (JP) (Part 15) Transitions in the Standards and Test Methods of Potassium Bromide in JP(1886) and JP X VI (2011), and Comparison between the USP and BP 13

Jun Okuda and Hiroshi Morita : Element Analysis of a Chinese Yagen Bearing the Inscription of Product of the Ming-Zhengde Period [Property of the Naito Memorial Museum of Pharmaceutical Science and Industry, Gifu] using an X-ray Fluorescence Spectrometer 33

Misato Ota, Masayuki Mikage and Shao-Qing Cai : Herbological Study on the Medicinal Effects of Roasted Licorice and Honey-roasted Licorice 38

Yohko Natsume : Tri-phal (Three Myrobalans) as Described in the Second Part of the Bower Manuscript, the Nvantaka 46

Kazushige Morimoto, Satoko Kawasaki and Yasunori Yoshida : Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval : Focus on Public Release of Review Reports regarding New Drugs and Medical Devices64

Chika Mouri and Masayuki Mikage : The Original Formulation for Toso-shu (Tusujiu), Created by the 3rd Century Chinese Physician, Hua Tuo 78

Research Note

Masahiko Goino : Pharmaceutical Regulations in the Japanese Hospitals in 1880s and the Case of a Scholar of Pharmacology in Oita Prefecture 84

Ken Ito, Soichiro Inubushi, Takafumi Moriwaki, Kazuhiro Matsunaga, Kyoko Takahashi, Takahiro Ueda, Setsuya Hashizume, Hiroaki Takemoto, Yoshinori Kobayashi, Tomoe Ota, Seiko Nakamura and Hisashi Matsuda : Visualization for Traditional Quality Management TechniquesCharacterization Method for Spikenard of INUBUSHI SEIYAKU Established in the Edo Period 89

web

113-0032 2-4-16tel : 03-3817-5821fax : 03-3817-5830e-mail : yaku-shi@capj.or.jpHPhttp://yakushi.umin.jp/00120-3-67473

1

5011-62015

*1

*2

History of Japanese Kampo Medicines Manufacturers*1

Ichiro Arai*2

1 2013 1,5991,493 93%34 2%73 5% 1,301 87%191 13%2010 2 83% 10% 7% 30% 11% 8%5% 46% 79% 12%

3 491950 9111956 12 OTC

*1

*2

2015 27 4 18 Professor, Nihon Pharmaceutical University, Department of Kampo Medicines. 10281 Komuro, Ina-machi, Kita-Adachi-gun, Saitama 362-0806.

2

1957 31 13/14, 15

1960 1961 1963 1963 161970 1971 171967 7 3 1930 147 1970 623 346 10, 111971 346 210 1975 18 1972 11 14 1 19

1967 9 4 3 1520 7 1976 21 33 19601970 210 21

3

1976 27 1980 154

1980 6 804 22 1 1980 804 1986

1980 1992 1,542 1980 101980 GOT,GPT 1992 25% C A B C C 1 C 3 1975 3 23

4

1995

1983 1983 5 24 3 251993 1997 2009 2015 2 1981 26, 2728311982 2 1985 2 120 32 3 1989 331991 1993 34, 351996 3 2 10 36372000 841 1992 1,542 55% 11992 25% 1999 10% 1997 2000 4 1990 381991 8 391995 1996 14 2 3 2014 4 401986

5

1986 1980 30 2008 2014 294 41 5

1 2015http : //www.nikkankyo.org/publication/movement/h25/all.pdfaccessed 1 May 2015

2 2 https : //www.nri.com/jp/event/mediaforum/2010/pdf/forum125_2.pdfaccessed 1 May 2015

32010617881-141947p. 54519486 1 19523126-307 2 19534219-238 3

19534223-692199440121685-96

1020022922611120065391467-8121956No. 852-313 35 1957410-111420043117115 19 2001243437-4516 1963196317 1972 1971181975191972456-6320 50 2002p. 7-8

6

21200552111771-422 804 1980. 6. 25.23

199225551-8.241983. 5. 325 15

199934246-5326

28 1981p. 3627 2

1983p. 71281986. 4. 19291986. 4. 19301986. 4. 23311986. 4. 2532 2 120 1985. 5. 3133 1

198927121556-6134No. 1071991. 335 No. 1181993. 136 10 1996. 3. 2371996. 33819951391668-7139 13 1991. 2. 140 26 1 04071 2014. 4. 7412013

7

5017-122015

*1

*2

History of Inorganic-pharmaceutics in Japan*1

Hiromu Sakurai*2

2015 5 118 113115117 118 114 1, 2118 29 89 89 63 3 123 B12

13, 4

460 3701292001493154119

*1

*2

2015 27 4 18 Professor Emeritus, Kyoto Pharmaceutical University

8

25220220280 365 45704762 22 6 5268

1882 R. 184319101927 -1960 - 1A1976 1B - P. 18541915187319381910 606 1C 15 1940 A. 186619199 1910 ICP 20 4, 68

18, 10

9

3 368, 10

20 inorganic drugsmetal-based drugsmetallopharmaceutics bioinorganic chemistry metallomics serendipity -II 1D1965 B.

19262009-1969100 1845 M181318831978 1983 11

1949 J. 191219801954 M. 1980

APLAPL 10 23 15201970 1 APL 2 2000 2008

34 1 D- 6000 1997 2008

1E

10

III 2014 III12

1 232419481949 6719941995 2 1318811975 1 1901 199319112010 60 19 6 30142 A. G. 18721938 71 18821980abcd151903 1962c193819561944161719232003 bioinorganic chemistry 19791836, 8, 10

19031994

-- 2A1945 1954 19-1961

11

2021 2B1968 1981 H2

L- N-- -L- 1900 1972 1975 L- CW CH 1978 22 L- 1990-

2C1994 3 1

2 2 DNA 19232010 3 1976 3200568, 11

28, 10

12

9, 23

1 1 8 20152 111 2 2013319694RIONA PRESS Vol. 1142014

199652001619877 3 1997820059Alfred Werner 2

198343-5010Sakurai H. Overview and frontier for the development of metallopharmaceutics, J. Health Sci. 2010; 56 (2) : 129-43.11Alderden RA, Hall MD, Hambley TW. The discovery and development of Cisplatin. J. Chem. Educ. 2006; 83 (5): 728-34.1220151354545-913a1955b

200014 I19571519803510786-816194417201482325-718197919200420Oligo 1

1967874376-8021Ishimori A. Mechanism of the antipeptic action of anionic carbohydrate and its clinical application for the treatment of peptic ul-

cer. Tohoku J.Exp. Med. 1971; 103 (2): 141-57.22Ogle CW, Cho CH. Protection by zinc sulphate against reserpine-induced ulceration and other gastric effects in the rat. Pharma-

cology. 1978; 17 (5): 254-61.23Migos KT, Orvig C. Metallo-drugs in medicinal inorganic chemistry. Chem. Rev. 2015; 114 (8): 4540-63.

310

13

50113-322015

15JP I1886JP X VI2011

USP BP

*1

Transition of Psychotropic Drugs in Japanese Pharmacopoeia JP Part 15 Transitions in the Standards and Test Methods of Potassium Bromide

in JP I 1886 and JP X VI 2011, and Comparison between the USP and BP

Kiyohisa Yanagisawa*1

Received November 17, 2014

1

1, 2 1826 Balard 18511864 Hemri Behrend 1853 Sir LycockVigouroux 1857 Sir Charles Locock 1868 Thomas Clouston 1912 21912 1950

2378 1826

*1 The Japanese Society for History of Pharmacy.

14

150 JP JP I1886 JP X VI2011 JP 120 1 3 JP I1886JP X II1991 911 1950 20 JPUSP BP

2JP I1886JP X VI2011

1JP I188614JP II189115JP IV

1920 17JP VI195119JP VII196120 JP VIII197121 JP X VI20112229JP VI1951USP 73 JP VII

1961JP VIII1971JP 2 1 JP I1886JP V1932

1418JP VI1951 1 g 1.5 cc 250 cc 5 cc19JP VII19611 g 2 cc 1 cc 250 cc 20 cc 5 cc 1 g 20 JP VIII197121 JP VII1971 1 g JP VI1951JP VI1951USP 73 JP VII1961JP VIII1971JP JP X VI201122293 1 JP I

1886JP V19321418 JP III

1906Br216JP VI1951JP VI1951 19 2 USP X IV195073USP JP X VI20112028JP VI19513031 USP X IV1950 81USP JP VII1961JP VI1951 2 2 32

15

33 JP VII1961JP X VI201121294 1 JP I

1886 4 14JP II189115JP III1906 3 169JP IV192017JP VI1951JP V

1932KCl JP VI1951 1 g N/10 83.284.5 cc

KCl 1 19 2 JP VI1951 USP195073USP JP VII1961JP VI1951 8 JP VI1951N/50 0.5 cc 0.024 1 g 0.1N 83.284.5 84.5 ml KCl 1 0.9 10 ppm JP VI1951

20JP VIII1971 9 JP VIII1971 10 ppm 5 ppm21 JP VII1961JP VIII1971USP JP VI1951JP JP VIII1971 JP X VI201122295 1 JP I1886 0.5 g 4243 ccm 96100 414JP II1891 0.2 g 17 ccm 9815 JP III1906 0.3 g 25.4 ccm 98.516JP IV1920 25.4 ccm 98.798 KBr16JP V1932 0.3 g 24.825.5 cc

98.0798.318 100 98.518JP IV1920 JP I1886JP V19329JP VI1951 Volhard

16

19 2 USP X IV195073 USP JP VII1961JP VIII1971

JP X VI20111929

1JP I1886JP X VI2011

JP I1886 JP II1891 JP III1906 JP IV1920 JP V1932 JP VI1951 JP VII1961 JP VIII1971 JP IX1976 JP X1981 JP X I1986JP X IV2001

JP X V2006JP X VI2011

KBr KBr119.11 KBr119.02 KBr119.0 KBr119.01 KBr119.02 KBr119.01 KBr119.0

991104 99.0

1.5 cc 2 cc 1 cc

5 cc 5 cc

20 cc

250 cc 250 cc

NG

NG NG NG

N/10 NG

0.1N NG

NG

N/50 0.5 cc

0.024

NG

NG NG

NG NG

NG

NG

0.001

10 ppm

1 10 ppm

NG

NG

10 NG

NG

NG

KBr1 g N/10 83.284.5 ccKCl1

KBr1 g 0.1N 84.5 ml 0.9

1 10 ppm

5 ppm

A

2 ppm B

KBr1.0 g 3 ml

KBr0.5 g 4243 ccmKBr96

KBr0.2 g 17 ccm KBr98

KBr0.3 g 25.4 ccm KBr 98.5

KBr98.7

KBr0.3 g 24.825.5 ccKBr98.0798.3

Volhard

17

3BP1885BP2014

1BP1885 BP1898BP1914

3436BP1932 37BP1973 42, 64BP1980 44BP2000

1JP I1886JP X VI2011

JP I1886 JP II1891 JP III1906 JP IV1920 JP V1932 JP VI1951 JP VII1961 JP VIII1971 JP IX1976 JP X1981 JP X I1986JP X IV2001

JP X V2006JP X VI2011

KBr KBr119.11 KBr119.02 KBr119.0 KBr119.01 KBr119.02 KBr119.01 KBr119.0

991104 99.0

1.5 cc 2 cc 1 cc

5 cc 5 cc

20 cc

250 cc 250 cc

NG

NG NG NG

N/10 NG

0.1N NG

NG

N/50 0.5 cc

0.024

NG

NG NG

NG NG

NG

NG

0.001

10 ppm

1 10 ppm

NG

NG

10 NG

NG

NG

KBr1 g N/10 83.284.5 ccKCl1

KBr1 g 0.1N 84.5 ml 0.9

1 10 ppm

5 ppm

A

2 ppm B

KBr1.0 g 3 ml

KBr0.5 g 4243 ccmKBr96

KBr0.2 g 17 ccm KBr98

KBr0.3 g 25.4 ccm KBr 98.5

KBr98.7

KBr0.3 g 24.825.5 ccKBr98.0798.3

Volhard

18

2USP V1870USP2014

USP V1870 USP VII1890 USP VIII1905 USP IX1916 USP X1926USP XI1936 USP X III1947USP X IV1950 USP X V1955USP282005 USP292006USP372014

KBr118.79 KBr118.22 KBr119.02 KBr119.02 KBr119.01 KBr119.00

97 10098.5 10098.5USP X I 99.0

110 4 99USP X IV 105

98.0100.5

wholly soluble 1.6 parts 1.5 parts 1.5 mils 1.5 cc

sparingly soluble 200 parts 180 parts 250 mils 250 cc 250 cc

4 parts 4.6 mils 4.6 cc 5 cc

1 parts 1 mil 1 cc

16 parts 21 mils 21 cc

0.2 ccNG

N/10 0.1 ccNG

N/10 0.1 cc 1

0.1N 0.10 cc 1

1 ml 0.01N HCl 0.01N NaOH 0.5 ml

NG 0.5 ccNG

NG N/15 0.5 cc

0.02N 0.5 cc USP X IV 250 ppm

0.020N 0.2 ml 0.01

NG NG

NG 1 cc NG 1 ml100 g/L 0.1 ml0.3M 0.25 ml 5NG

NG

Time Limit Test 10 ppm

10 ppm

0.5 ccNG

NG NG 1 ccNG

NG

NG

1 ccNG

10.5 g/100 ml 0.15 ml 2 ml

NG USP X I USP X IV 10 ppm

3 KBr g 0.1N 83.284.5 cc

5 mldibutyl phthalate1 ml1.7 ml

0.5 ccNG

20 ppm 2.0 ml 0.1 ml 5

NG

0.5 ccNG

NG

0.01M edetate disodium 0.01M edetate disodium 5.0 mlCa 0.02

KBr10 g 1430 g

KBr0.5 g 42.85 cc KBr97

KBr0.3 g N/10 24.625.85 ccKBr96.997

Volhard

KBr g82.884.8 ccN/10 USP X I KBr g83.284.5 ccN/10

KBr g83.284.5 ccN/10 USP X IV

Volhard KBr a3.357b

19

2USP V1870USP2014

USP V1870 USP VII1890 USP VIII1905 USP IX1916 USP X1926USP XI1936 USP X III1947USP X IV1950 USP X V1955USP282005 USP292006USP372014

KBr118.79 KBr118.22 KBr119.02 KBr119.02 KBr119.01 KBr119.00

97 10098.5 10098.5USP X I 99.0

110 4 99USP X IV 105

98.0100.5

wholly soluble 1.6 parts 1.5 parts 1.5 mils 1.5 cc

sparingly soluble 200 parts 180 parts 250 mils 250 cc 250 cc

4 parts 4.6 mils 4.6 cc 5 cc

1 parts 1 mil 1 cc

16 parts 21 mils 21 cc

0.2 ccNG

N/10 0.1 ccNG

N/10 0.1 cc 1

0.1N 0.10 cc 1

1 ml 0.01N HCl 0.01N NaOH 0.5 ml

NG 0.5 ccNG

NG N/15 0.5 cc

0.02N 0.5 cc USP X IV 250 ppm

0.020N 0.2 ml 0.01

NG NG

NG 1 cc NG 1 ml100 g/L 0.1 ml0.3M 0.25 ml 5NG

NG

Time Limit Test 10 ppm

10 ppm

0.5 ccNG

NG NG 1 ccNG

NG

NG

1 ccNG

10.5 g/100 ml 0.15 ml 2 ml

NG USP X I USP X IV 10 ppm

3 KBr g 0.1N 83.284.5 cc

5 mldibutyl phthalate1 ml1.7 ml

0.5 ccNG

20 ppm 2.0 ml 0.1 ml 5

NG

0.5 ccNG

NG

0.01M edetate disodium 0.01M edetate disodium 5.0 mlCa 0.02

KBr10 g 1430 g

KBr0.5 g 42.85 cc KBr97

KBr0.3 g N/10 24.625.85 ccKBr96.997

Volhard

KBr g82.884.8 ccN/10 USP X I KBr g83.284.5 ccN/10

KBr g83.284.5 ccN/10 USP X IV

Volhard KBr a3.357b

20

47 BP2014 48582 3 BP1885

readily soluble in water, less soluble in spirit34BP1898soluble in 2parts of cold water and in 200parts of alcohol90 percent35BP1948 15.538BP1953 201.6parts of wateralchol95%39BP1973 43, 64 3 3 BP1885 34BP1898 35BP1898BP1932 23 3 2 59BP1953 60BP1973 IV magenta solution 2 2 61, 65BP2000 IV fuchsin solutionR 62 1973 EC BP1973

1969 EP BP1973 4BP1885 3 3 34BP1898 14 35BP1914 BP1898 BP1898 10 ppm5 ppm 36BP1932835 ppm 2 ppm 37BP1953 9 39BP1963 0.241BP1968 42BP1953 3.7 ml 39BP1968N/10 42BP1973BP1980 10w/v 0.01M HCl0.01M NaOH 0.5 ml 100 ppm 10 ppm 20 ppm 100 ppm100 ppm

21

magnesium uranyl acetate 0.1M 1.0KCl BP1973BP1980 ironIII chloride hexahydrate BP1973 43, 44, 64BP1973 1969 EP62 BP1988 3 0.01M disodium edetate 5 ml Ca 200 ppmBP1968 0.5M 0.1M dibutyl phthalate 0.1M 1.7 ml0.645BP2000 47solutionS BP2014 4858BP2002 49BP2013 575 3 BP1885 10 g 838850 grains measures

98.0799.7234BP1898 1 g 83.785.4 cc 98.4598.9235BP1914 0.5 g N/10 41.242.5 cc 98.098.04%36BP1932 Volhard37 BP1968 3842BP1973 43, 44, 64 BP1973 1969 EP64 BP1988 Volhard 45 Volhard BP2002 a3.357bKBra KBr KCl KBr bCl 49 KBr BP2013 0.1M 57

4USP V1870USP X IV1950

1USP V187066USP VII189067USP VIII190568USP X192670USP X III1947

22

3BP1885BP2014

BP1885 BP1898 BP1914 BP1932BP1948 BP1953 BP1958BP1963 BP1973BP1980 BP1988BP1993 BP2000BP2001 BP2002BP2012 BP2013BP2014

KBr119.0 KBr118.18 KBr119.02 KBr119.0

100 98 110 99 BP194898.5

105 98.5 BP196310599.0

98.0% 98.0100.5 KBr

98.5101.0 KBr

readily soluble 2 parts 1.6 parts

less soluble 200 parts 200 parts 95 96

96

1 23

2

3

IV magen-ta solution

fuchsin solutionR

BP2005 IV

1

2

-

123NG

1

2

10w/v%

solutiomS

N/500.2 cc 1 NG

N/50 0.2 cc 1 NG

0.2 ml N/10 0.2 ml

0.01M HCl 0.01M NaCl0.5 ml

NG

100 ppm

100 ppm 100 ppm

NG NG

BP1963 0.1 ml 1 ml 5 NG

5 mlM 1 ml 1 ml

1 ml 0.1 ml0.5M 0.25 ml 5 NG

NG

5 NG

5 mlM 6 ml

5 ml1M 1 ml 6 ml

R5 ml1 ml R6 ml

20 ppm 20 ppm

23

3BP1885BP2014

BP1885 BP1898 BP1914 BP1932BP1948 BP1953 BP1958BP1963 BP1973BP1980 BP1988BP1993 BP2000BP2001 BP2002BP2012 BP2013BP2014

KBr119.0 KBr118.18 KBr119.02 KBr119.0

100 98 110 99 BP194898.5

105 98.5 BP196310599.0

98.0% 98.0100.5 KBr

98.5101.0 KBr

readily soluble 2 parts 1.6 parts

less soluble 200 parts 200 parts 95 96

96

1 23

2

3

IV magen-ta solution

fuchsin solutionR

BP2005 IV

1

2

-

123NG

1

2

10w/v%

solutiomS

N/500.2 cc 1 NG

N/50 0.2 cc 1 NG

0.2 ml N/10 0.2 ml

0.01M HCl 0.01M NaCl0.5 ml

NG

100 ppm

100 ppm 100 ppm

NG NG

BP1963 0.1 ml 1 ml 5 NG

5 mlM 1 ml 1 ml

1 ml 0.1 ml0.5M 0.25 ml 5 NG

NG

5 NG

5 mlM 6 ml

5 ml1M 1 ml 6 ml

R5 ml1 ml R6 ml

20 ppm 20 ppm

24

722 2 USP V187066USP VII1890155967USP VIII19051.6parts 1.5parts200parts 180parts 2577USP VII 4parts68USP IX191625

1 g 1.5mils 180parts 250mils 4.6mils 1mil

16parts 21mils69USP X III1947 1 g 1.5 cc 250 cc4.6 cc 5 cc723 2 USP V187066USP VII189012

3BP1885BP2014

BP1885 BP1898 BP1914 BP1932BP1948 BP1953 BP1958BP1963 BP1973BP1980 BP1988BP1993 BP2000BP2001 BP2002BP2012 BP2013BP2014

N/10 1.3 cc

N/10 5 ml 5 N/10 3.7 ml

25w/v% 0.1M 5 ml1 ml 0.1M 1.0KCl

0.1M 5 mldib-utyl phthalate 1 ml 0.1M 0.1M1.7 ml 0.6

Note the volume of 0.1M silver nitrate used

0.6

0.60%

5 ppm 2 ppm BP19482 ppm

10 ppm 10 ppm BP194810 ppm

3.0 ml95 2.0 ml 0.5 ml 15NG

0.2 BP1968

4.5 mlMagnesium uranyl acetate 5 ml 10

100 ppm

10 ppm

10 ppm

1 ml0.15 ml2.5w/ v% 0.25 ml2M 5 ml 10 ml 100 ppm

0.01M disodium edetate 5 ml 200 ppmCa

0.01M sodium edetate 5 ml

200 ppmCa

10.5w/v%ironIIIchloride hexa hydrate 0.15 ml

0.15 ml ferric chloride solution R1

KBr10 grains 838850 grains measuresKBr98.0799.72

KBr1 g 83.785.4 ccmKBr98.4598.92

KBr0.5 g N/10 41.242.5 ccKBr98.098.04

Volhard

0.02M

Volhard

KBr a3.357b

0.1M

EP

EP1.01969 EP2.01983 EP3.01997 EP4.0 2002 EP5.0 2005EP6.0 2008 EP7.0 2011

EP7.52012EP8.02014

25

267USP VIII190512 68USP X1926701 2 2 2

81 USP X IV19504 2 USP V187066USP VII1890 67USP VIII1905 5

3BP1885BP2014

BP1885 BP1898 BP1914 BP1932BP1948 BP1953 BP1958BP1963 BP1973BP1980 BP1988BP1993 BP2000BP2001 BP2002BP2012 BP2013BP2014

N/10 1.3 cc

N/10 5 ml 5 N/10 3.7 ml

25w/v% 0.1M 5 ml1 ml 0.1M 1.0KCl

0.1M 5 mldib-utyl phthalate 1 ml 0.1M 0.1M1.7 ml 0.6

Note the volume of 0.1M silver nitrate used

0.6

0.60%

5 ppm 2 ppm BP19482 ppm

10 ppm 10 ppm BP194810 ppm

3.0 ml95 2.0 ml 0.5 ml 15NG

0.2 BP1968

4.5 mlMagnesium uranyl acetate 5 ml 10

100 ppm

10 ppm

10 ppm

1 ml0.15 ml2.5w/ v% 0.25 ml2M 5 ml 10 ml 100 ppm

0.01M disodium edetate 5 ml 200 ppmCa

0.01M sodium edetate 5 ml

200 ppmCa

10.5w/v%ironIIIchloride hexa hydrate 0.15 ml

0.15 ml ferric chloride solution R1

KBr10 grains 838850 grains measuresKBr98.0799.72

KBr1 g 83.785.4 ccmKBr98.4598.92

KBr0.5 g N/10 41.242.5 ccKBr98.098.04

Volhard

0.02M

Volhard

KBr a3.357b

0.1M

EP

EP1.01969 EP2.01983 EP3.01997 EP4.0 2002 EP5.0 2005EP6.0 2008 EP7.0 2011

EP7.52012EP8.02014

26

USP VII1890USP VII1890Time Limit Test 68USP IX1916 USP VIII

1905 USP VII189069USP X1926N/15 0.5 cc 70USP X I193671USP X III194710 ppm 72USP X IV1950250 ppm 10 ppm 730.1N 83.284.5 cc 735 2 USP V1870 10 g 1430 g 66USP VII1890 0.5 g 42.85 cc 97367USP VIII1905 0.3 g N/10 24.625.85 cc 96.99768USP IX1916 Volhard

g N/10 82.884.8 ml 69USP X I193683.284.5 cc 71USP X IV195073

5USP292006USP372014

1 2 741 2 2 2 822 2 0.01NHCl 0.01NNaOH 0.5 ml 10 ppm 20 ppm 0.01M edetate disodium 5.0 ml Ca 0.02 - 0.5M 1.7 ml 10.5 g/100 ml 0.020N0.2 ml0.0174 USP X IV1950 BP2002BP20124956 EP8387 50 USP

27

BPEP 3 2 USP292006 USP X IV1950 Volhard BPEP a3.357b

KBra KBr KCl KBr bCl74 BPEP

6

1826 Balard 150 JP BP 1 1990 3 1991JP I

1886JP X II1991 USPBP 911JP I1886JP V19321418USPV

1870USP X II19476672BP1885BP19483438

3 3

4

kg

1953 30,081 81,815

1954 32,022 90,289

1956 29,717 85,084

1957 27,948 79,758

1958 25,681 76,923

1959 24,319 72,794

1960 22,421 67,872

1961 21,278 65,684

1962 14,072 42,957

1963 12,164 35,969

1984 1,799 759

1985 883 358

1986 910 390

1988 786 339

1989 774 319

1990 775 319

19531990

119531990

28

Volhard 1990 USP USP X V19551950 JP JP VI1951 USP 73 19JP VII1961JP VIII1971 JP 20, 215 JP IX1976 JP X VI20112229 4 5 88 19531990 4 5

19641983 881954 1990 1/283 1/41 881950

5

1953 10,229 1,174

1956 9,679 1,285

1961 21,699 4,321

1966 65,103 2,893

1971 149,489 6,093

1976 230,815 8,763

1981 353,907 13,942

1986 430,516 20,076

1991 572,281 56,403

1996 561,584 59,433

2001 551,394 74,343

2006 562,200 72,828

2011 849,373 85,082

19532012

219532012

29

BP BP1973BP1980BP1988 4345 BP19731969 EP64 1973ECEP BP1973 EP64 BP1988 EP 45EP EC EP BP EC BP1973 EC 21 2000 2014 JP X IV

2001JP X VI20112729 JP IX197622 JP BP BP2002

a3.357b KBr 47 Volhard KBr USP29200674 USP3720147580 JP X VI2011 Volhard 29 JP

BP2013 Volhard 57 EP 86 EP JPUSP USP292006USP X IV1950 50 74 BP2002BP20124956 EP8387 USP BPEP USP BPEP JPUSPBPEP JP I1886JP X VI20111429 JP USP29200674 3789

30

8 USP32200976 JPUSPBPEP 21 37 888 1 3 911 20 USP29200674BP2013 57 20 JPBP 12, 13 9092 JP I1886 JP X VI2011 USP 21

7

JPBP JP USPBPEP JP USP292006 50 74 BP2013 57 378

11922p. 6421960p. 406-73

1 199830suppl244

4200436suppl5303

59 200638suppl274

6200840suppl265

7201042suppl5264

31

8 1 1998515365-7

9 1JP IJP V 199025141-54

10 21990252128-35

11 3JP VI X II JP X II BP X IV 199126279-86

12 12USP20002011 BP19802011201247144-54

13 13JP I1886JP X VI2011 USP BP 201348163-74

141890p. 585-8151891p. 11816

1906p. 667-81171921p. 468-71181949

p. 414-619

1951p. 414-620

1961C745-821

1971C884-722

1976C781-523

1981C887-9124

1986C912-625

1991C1214-726

1996C1402-6272001p. 484-528

2006C1796-80029

2011C2044-730

1951p. 1045

311951p. 1047-8

321961B55-6

331961B60

34British Pharmacopoeia 1885. 1885. p. 322-335British Pharmacopoeia 1898. 1898. p. 261-236British Pharmacopoeia 1914. 1914. p. 308-937British Pharmacopoeia 1932. 1932. p. 348-938British Pharmacopoeia 1948. 1948. p. 426-739British Pharmacopoeia 1953. 1953. p. 434-540British Pharmacopoeia 1958. 1958. p. 508-941British Pharmacopoeia 1963. 1963. p. 630-142British Pharmacopoeia 1968. 1968. p. 788-943British Pharmacopoeia 1973. 1973. p. 37444British Pharmacopoeia 1980. 1980. p. 35845British Pharmacopoeia 1988. 1988. p. 45246British Pharmacopoeia 1993. 1993. p. 527-847British Pharmacopoeia 2000. 2000. p. 1254-548British Pharmacopoeia 2001. 2001. p. 1337-849British Pharmacopoeia 2002. 2002. p. 1396-750British Pharmacopoeia 2003. 2003. p. 1521-251British Pharmacopoeia 2004. 2004. p. 1588-952British Pharmacopoeia 2005. 2005. p. 1616-753British Pharmacopoeia 2009. 2009. p. 1665-654British Pharmacopoeia 2010. 2010. p. 172555British Pharmacopoeia 2011. 2011. p.172656British Pharmacopoeia 2012. 2012. p. 177257British Pharmacopoeia 2013. 2013. p. 1817-858British Pharmacopoeia 2014. 2014. p. II-620-159British Pharmacopoeia 1898. 1898. p. 419-20 ; p. 42760British Pharmacopoeia 1953. 1953. p. 722 ; p. 72761British Pharmacopoeia 1980. 1980. A82 ; A8462British Pharmacopoeia 2000. 2000. A16963British Pharmacopoeia 2005. 2005. A21464European Pharmacopoeia 1.0. 1969. p. 313-565European Pharmacopoeia 1.0. 1969. p. 97 ; p. 10166Pharmacopoeia of USA V. 1870. p. 252-367Pharmacopoeia of USA VII. 1890. p. 316-768Pharmacopoeia of USA VIII. 1905. p. 357-869Pharmacopoeia of USA IX. 1916. p. 333-470Pharmacopoeia of USA X. 1926. p. 297-871Pharmacopoeia of USA X I. 1936. p. 29872Pharmacopoeia of USA X III. 1947. p. 421-273Pharmacopoeia of USA X IV. 1950. p. 483-474Pharmacopoeia of USA 29. 2006. p. 175975Pharmacopoeia of USA 31. 2008. p. 3030-176Pharmacopoeia of USA 32. 2009. p. 3334-677Pharmacopoeia of USA 34. 2011. p. 3962-378Pharmacopoeia of USA 35. 2012. p. 4357-979Pharmacopoeia of USA 36. 2013. p. 4836-7

32

80Pharmacopoeia of USA 37. 2014. p. 4347-881Pharmacopoeia of USA X. 1926. p. 441 ; p. 44482Pharmacopoeia of USA 29. 2006. p. 2550-183European Pharmacopoeia 5.0. 2005. p. 2273-484European Pharmacopoeia 6.0. 2008. p. 2716-785European Pharmacopoeia 7.0. 2011. p. 2761-286European Pharmacopoeia 7.5. 2012. p. 4686-787European Pharmacopoeia 8.0. 2014. p. 3063-4

88 28 24 19532012

892009

901894p. 102

911952p. 4-5p. 33921937 7625

Summary

In mental clinics, bromide agents such as potassium bromide were often once used as therapeutic drugs to treat psychiatric disorders. They were also given as hypnotic, sedative and antiepileptic medicines. However, the appearance of new medicines has resulted in them not being used for these purposes in recent years. Potassium bromide is still continuously listed in todays JP and BP. This suggests that it maintains value as a basic medicine for treating mental disorders in the history of psychotropic medicines. However, regarding the standards and test methods for potassium bromide in the present JP, as a result of a comparison be-tween the USP of the same age, BP and EP, a gap is seen, and this is very regrettable. The exchange of art and scientific information related to medical sciences with foreign countries is becom-ing more active today. Therefore, scholarly information overseas should be collected and reflected in the standards and test methods for potassium bromide adopted in the JP of Japan. The author believes that the standards and test methods comparable to those at the international level should introduced.On the other hand, potassium bromide was recetnly relisted by USP29 (2006) for the first time in approxi-mately 50 years. Moreover, instrumental analysis was introduced as part of the test methods in BP2013; that is, an epoch-making revision was made in terms of test methods. It is assumed from this that there is a sign of new change regarding the existence of potassium bromide as hypnotic, sedative and antiepileptic medi-cines, and its utility value. It is believed that the sign of change in view of the utility value and pharmacolog-ical evaluation probably arose with the new clinical knowledge that potassium bromide was used to treat a baby seriously ill with myoclony epilepsy, as wll as to treat a dog with epilepsy.

33

50133-372015

X

*1*3*4

Element Analysis of a Chinese Yagen Bearing the Inscription of Product of the Ming-Zhengde Period Property of the Naito Memorial Museum of Pharmaceutical Science and Industry,

Gifu using an X-ray Fluorescence Spectrometer

Jun Okuda*1*3 and Hiroshi Morita*4

Received December 2, 2014

28 cm 10 1

26

16.5 cm2, 315061521 A.D. X

1

1 12.6 cm 3.3 cm 3.2 cm 122 33 cm8.3 cm 6.8 cm 34

2

2639

*1*2*3*4

Faculty of Pharmacy, Meijo University. 150 Yagotoyama, Tempaku-ku, Nagoya, Aichi 468-8503.Professor Emeritus of Meijo University.Honorary member of Japanese Society for History of Pharmacy.Director of The Naito Museum of Pharmaceutical Science and Industry.1 Kawashima-takehaya Kakamigahara, Gifu 501-6195.

34

346

4 Co, Mn, Fe5, 6 Asbolite7Al2Si2O5OH4 Co MnNi Zaffer7Co

4 X

1267-1 X EDX-720

1

2

4

3

35

1 30 cm 33 cm X a

5 X a8, 9

a 1 a a 13 cm 6.8 cm a 1 SiKCaTiFeZnCeCuRbSrZr 11 Cu 0.125

2 SiKCaCoAlZnFeTiPbCeZrRbSr 13 CoAlPb 3 Co 7.910Al Pb 0.255 Mn X 2

1 a X 11

Si 62.829%K 17.138Ca 13.519Ti 2.550Fe 2.145Zn 1.157Ce 0.267Cu 0.125Rb 0.091Sr 0.090Zr 0.090

2 a X 13

Si 59.126%K 10.840Ca 8.892Co 7.910Al 7.768Zn 1.937Fe 1.573Ti 1.337Pb 0.255Ce 0.160Zr 0.072Rb 0.066Sr 0.064

4 X 15

Si 59.013%K 14.488Ca 8.895Co 4.380Fe 4.109Mn 3.583Ce 2.234Ti 1.365Zn 1.065Cr 0.285Rb 0.229Cu 0.224Sr 0.059Zr 0.048Y 0.023

3 X 12

Si 65.752%K 16.226Ca 10.975Ce 2.418Fe 2.203Ti 1.535Zn 0.495Rb 0.173Cu 0.145Sr 0.039Zr 0.026Y 0.013

36

3 12 SiKCaCeZnFeTiRbCuSrZrY Fe 2.203CoMn 15SiKCaCo4.380 %Fe4.109 %Mn3.583 %CeTiZnCrRbCuSrZrY 4 CoMn Fe 4.1092.2031.906 CoMnFe Cr 0.285

6

7

12 34 8 59

8

15061521 A.D. X CoMn Fe X

5

37

1 2013 2013 10 5

2 2013 2013 11 17

3 .2008

42008p. 1017p. 10185 3 1981619797 5 1998. p. 121p. 24648 319829http://humi.cside.com/

hukken/GAIYOU/syousyu.htmlaccessed 28 June 2014

Summary

Yagenis an oriental grinder for crude plant medicines. It consists of a disk and navicular mortar. A Chinese yagen with the inscription, Product of the Ming-Zhengde Period (15061521 A.D.) has been housed for 40 years in the Naito Memorial Museum of Pharmaceutical Science and In-dustry (Kakamigahara, Gifu Prefecture, Japan). To identify the district that produced this yagen, the authors analyzed the elements using an X-ray fluorescence spectrometer.The results showed that the blue design and blue Chinese characters on the yagen were enameled with elements of cobalt, manganese, and iron. Therefore, it is believed that the yagen was made in an old porce-lain kiln near Zhangzhou in Fujian Province, China. However, as the period of production could not determined in the present study, further research is need-ed in the future.

38

50138-452015

*1,*3*2*1

Herbological Study on the Medicinal Effects of Roasted Licorice and Honey-roasted Licorice

MisatoOta*1,*3,MasayukiMikage*2andShao-QingCai*1

ReceivedJanuary19,2015

1233,4a5,67 16 8

4b42047910

4c5C 4d11164e682911071110

1

*1

*2

*3

Division of Pharmacognosy, School of Pharmaceutical Sciences, Peking University Health Science Center. 38XueYuanRoad,Beijing,100191,China.Laboratory of Plant Conservation, Department of Human and Animal-Plant Relationships, Faculty of Agriculture, Tokyo University of Agriculture.1737Funako,Atsugi,Kanagawa243-0034.Uchida Wakanyaku Co., Ltd.4-4-10Higashi-nippori,Arakawa,Tokyo116-8571.

39

4f1234104g12481112a12664h1295

1

4i-113844j15204f4k15784l1578300

2 4m16164g4l4n1496

1

4o16954p1737 2 4i4q17584r16642l

41212b

40

1 1

500 4c

1116 4d

1234 4f

1248 4g

1266 *,12a

1295 4h

1384 4i-1

1496 4n

1520 4j

1578 4l

1578 4k

1616 4m

1660 4w

1664 4r

1666 4

1694 4v

1695 4o

1737 4p

1753 4x

1758 4q

1829 4

1833 4

1837 4a

1841 4

1885 4s

1915 4t

1948 4u

*

41

1 1

500 4c

1116 4d

1234 4f

1248 4g

1266 *,12a

1295 4h

1384 4i-1

1496 4n

1520 4j

1578 4l

1578 4k

1616 4m

1660 4w

1664 4r

1666 4

1694 4v

1695 4o

1737 4p

1753 4x

1758 4q

1829 4

1833 4

1837 4a

1841 4

1885 4s

1915 4t

1948 4u

*

42

4j4k15784l1315654s18854t1915

4u19481416824u 1

12c4l4v

16944w1660

2

1562 4y

1623 4z

1669 4

1698 4

1723 4

1723 4

1734 4

1747 4

1756 4

43

4x1753 1

2

4y15624z16234 16694 16984w

2

4 17344 1747 4j4

4 1723

14 2 2 4f12a 300 4l4

44

2010 734o44i-21384

4 169154x

2

6

1516

12000

219793

2003382151-604

1999a12361-8b4458c592d

45

16390e166516f2219g22116-8h83358i123243-4223242j26191-2k56413-4l38514-7m6660n25329-30o10174-5p107354q103416r89278-82s144480t151326u157211-3v10248-9w8789-90x102443-6y355399z3122231240831779-9332347-51316170-53204309646885532-4114445121168-70138438-9321141-3321223-4

5 20134

6201016121164-6

7 2010 2010

8 16 http://jpdb.nihs.go.jp/jp16supp2/

92013p159

101999p.130-2

1128 4199011299-105

122012ap561bp.7968p.775838p777p771p.62498p.607771cp.480-15065715931027

132011p90

142007p213

1520071881804-6

16ChengA,WanF,WangJ,JinZ,XuX.Macrophageimmu-nomodulatoryactivityofpolysaccharidesisolatedfromGly-cyrrhiza uralensisFish.Int Immunopharmacol.2008;8143-50

Summary

InChina,thecrudedruglicorice(kanzoinJapanese,gancaoinChinese)hasbeenusedbothdriedandroastedasthesituationdemandsfromancienttimes.Themeaningofroastedlicoriceissimplyroastedandhoney-roastedinancientandmoderntimes,respectively.However,itisnotclearmedicinalpurposesofpro-cessedlicoriceorwhylicoriceprocessedwithhoneybegantobeused.Weresearchedancientliteratureandfoundthatthemainobjectiveofroastingwastochangethepropertyoflicoricefromcooltowarm(i.e.,driedlicoricehadtheeffectofdrainingfire),whileroastedlicoricewasusedasanenergysupplement,havingadigestiveeffectandthuswarmingthebody.Meanwhile,doctorsbeganusinghoney-roastedlicoricetotreatthroatpainfromtheSongdynasty,andthenattheendoftheQingdynasty,honey-roastedlicoricewasex-pectedtohavethesameeffectsofroastedlicorice(i.e.,supplementingenergyandhavingadigestiveeffect).

46

50146-632015

2

*1

Tri-phal (Three Myrobalans) as Described in the Second Part of the Bower Manuscript, the Nvantaka

Yohko Natsume*1

Received January 20, 2015

1

1

Carakasahit CS2

Surutasahit SS3

Agahdayasahit AHS4 2

Nvantaka 11 Hartak-kalpa

2 Tri-phal3 5 3 1.

9 1300 1011 C 12900

vsanta

*1 Department of Pharmacognosy, Graduate School of Pharmacy, Meijo University. 150 Yagotoyama Tempaku-ku, Nagoya, Aichi 468-8503.

47

1314 3 2

2

3 4 5 CS SS AHS 6

3

3

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tri 3 phala

phal163 3

dtu17

varrehphalottam1819202123 2.

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Terminaliachebula, Retz.

Chebulicmyrobalan

malaka

6 Embelicaofficinalis Gaertn7 Emblic myrobalan

Vibhtaka8

Terminaliabelerica Roxb. Belleric myrobalan

2

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22 H zY gn z

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24

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3 225 152 26 9

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bioavailability92

International Society for the History of Pha-rmacy Research Fellowship 2014201525 26 National Institute of Pharmaceutical Education and Research NIPER K.K. Bhutani S. M. Tripathi A. S. Sandu

1 2 2013; 481: 75-88

2Charaka SahitVol. 1-4, translated by R. K. Sharma and Bhagawan Dash. Varanasi: Chowkhamba Sanskrit Series Office, 1998

3Suruta SahitVol.1-3, translated by Srikantha Murthy. Varanasi: Chaukhambha Orientalia, 2008

4 AgahdayasahitVol. 1-3, translated by Srinkantha Murthy. Varanasi: Chowkhamba Krishnadas Academy, 2009. Vgbhaa Vgbhaa I 6 7 Agasahit Vgbhaa II Agahdayamsahit 8

5 2 2013; 481: 75

61986. p. 157-72. : 1975. p. 1448b

7 Phyllanthus emblica Linn.8Bibhtaka Thakur Balwant

Singh. Glossary of Vegetable Drugs in Bhattray. Varanasi; Chaukhamba Amarabharati Prakashan, 1999. p. 274 U. C, Dutt. Materia Medica of the Hindus. Varanasi; Chowkhamba Saraswatibhawan, 1980. p.163

Vibhtaka b v

9 2 2013; 481: 76

10Government of India, Ministry of Health and Family Welfare, Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy. Ayurvedic Pharmacopeia of India, Part I, Vol. 2. New Delhi: Government of India, 2008. p. 4, 5

111979. p. 5, 6.

12gallic acid C6 H2OH3 COOH 170.12http://kusuri-jouhou.com/crude/flavonoid_tannin.html accessed 10 Dec 2014

13

141986. p. 17515WHO

http://www.who.int/medicines/areas/traditional/definitions/en/index.html

accessed 10 Dec 201416triphal

17CS3. 1. 1. 418Bhagwan Dash. Materia Medica of Ayurveda based on

Ayurveda Saukhyam of Toarnanda. New Delhi: Concept Publishing Company, 2000. p. 451

19Abdullh Bin Sn Qnn fil obb-book V. New Delhi: Department of Islamic Studies Jamia Hamdard, 2002. p. 22-5. Itrifal 3 Ma ajinAl-Itrifalal-Kabir 3 , Zamahran al-Kabir Al-zamahran al-Saghir 5 25 Itrifal

20Bhagwan Dash. Pharmacopoea of Tibetan Medicine. New Delhi: Sri Satguru Publication, 1994. 30 3 Alex Wayman, Notes on the Three Myrobalans. Phi theta annual papers of the Oriental Languages Honor Society. University of California. 1954. 63-77

21

61

1 2010. p. 68, 167, 173-4 http://www.zwbk.org/MyLemmaShow.aspx?lid=114717 accessed 22 December 2014 ; ; HPLC 2010: 12 : 46-7

22Mahdihassan S, Triphala and its Arabic and Chinese synonyms. Indian Hairs Sci. 1978; 131: 50 san-teng

23 , 2013. p. 8. 5 1970. p. 357; p. 611 7 Hartak, malaka, Vibhtaka

24; 2004. p. 284; p. 290 28

25Government of India, Ministry of Health and Family Welfare, Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy. Ayurvedic Pharmacopeia of India, Part II, Vol. I-III. New Delhi: Government of India, 2007.

26CS1. 1. 41-327CS1. 1. 50-328CS1. 26. 57-8 3

, , ,

29CS1. 26. 25-730CS6. 1: 1. 29-3731CS6. 1: 1. 29-3732CS1. 27. 149, 6.1. 29-37, CS1. 26. 48-9, CS6. 27. 50-2, CS1.26.

46-7. CS1. 26. 48-9 gheecavyacitraka

33CS6. 12. 7134CS1. 2. 935CS1. 4. 2436CS1. 23. 1037CS6. 1. 1. 1-238CS6. 1. 1. 7, 8, CS6. 1. 76

39CS6. 1. 1. 440CS6. 1. 1. 7541 3

42 5

43CS6. 1. 1. 7644CS6. 1: 1. 42-5. pacamla jvaka,

abhaka, med, jvant,atvar

45pippal: Piper longum Linn.madhka: Glycyrrhiza glabra Linn.kakkola: Piper cubebe Linn.tmagupt: Canavalia ensiformis Linn. jvaka: Menispermum cordifolium Willd. abhaka: Microstylis wallichii Lindle. vidri: Ipomaea digitata Linn.

461979. p. 67

47CS6. 1. 77-80. Surendranath Dasgupta. A History of Indian Philosophy Vol. II. Delhi, Motilal Banarsidass Publishers Private Limited, 2006. p. 294 , Dasgupta 1887-1952CS6. 1. 77

48Surendranath Dasgupta. A History of Indian Philosophy Vol. II. Delhi, Motilal Banarsidass Publishers Private Limited, 2006. p. 295. Dasgupta CS6. 3. 6

62

1 1 3 1-3 Brahman Chndogya-Upanisad

49CS6. 1: 3. 41-750tugkr: Curcuma angustifolia Roxb.51viaga: Embelia ribes Burm. F.

vicar: Acorus calamus Linn.52 4

2009. p. 99-13253SS1. 40. 354SS1. 40. 11-255SS1. 40. 5-956CS1. 26. 4557CS1. 17-21, SS1. 40. 3.

13-6

58SS1. 38. 54-5 Cyperus Rotandus, Linn. 59SS1. 38. 56-76061SS1. 39. 4 62SS1. 44. 6, 2363

1997. p. 7364SS4. 29. 20, 2165SS4. 28. 5. Brhm: Heresies monniera H. B.

& K. :

66Monier Monier-Williams. A Sanskrit-English Dictionary. Manohar Publishers & Distributors, 2006. p. 378

67 25 1 kg Ayurvedic Formulary of India, Part I p.75 ghta

681 0.5 81 gm 1 48 gm amta: Coccolus cordifolius DC.

69CS1. 27. 232

70CS1. 30. 28. 1kyacikits, 2lkya, 3 alypahartka, 4

viagaravairodhikapraamana, 5bhtavidy, 6 kaumrabhtyaka, 7 rasyana, 8

vjkaraa71AHS1. 6. 153-772AHS1. 6. 15873AHS1. 6. 158742006. p.

3861960. p. 334-46 11 55, 57 91, 93-96, 99, 148, 150 3

75AHS1. 6. 15976Meulenbeld. G. J. A History of Indian Medical Literature.

Groningen Oriental Studies IA. Groningen: E. Forsten, 1999. p. 333-57. Meulenbeld SS 3-4 3

77 1 2 3 2 34

78CS 12 CS1. 12. 3-10 CS1. 12 .11 CS1. 12. 12 CS1. 1. 59

79CS2. 3. 1-1880CS3. 2. 1-4. 3

81CS1. 20. 14. 1996. p. 176-8. katajakayajas 5

82CS1. 20. 1783 935 940

944 84

1992. p. 67 vibhtaka vibhdaka

63

852008. p. 11, 130-7. aka-priya

86CS1. 11. 15487CS1. 26. 53. Charaka

SahitVol. 3, translated by R. K. Sharma and Bhagawan Dash. Varanasi: Chowkhamba Sanskrit Series Office, 1998. pp. 14, 15. CS 2 10 5 1 5 6 5

881981. p. 62-689

4 2005. p. 205-7.

90Elwood PC, Waters WE, Greene WJ. Association between Circulating Haemoglobin Level, Serum-Cholesterol, and Blood-Pressure. The Lancet. 1970; 2 (7665) : 175-7

91Meulenbeld GJ. The Mdhavanidna with Madhukoa, the Commentary by Vijayarakita and rkahadatta (Chapters 1-10). Motilal Banarsidass Publishers Private Limited, 2008. p. 269

92 Bioavailability1977. p. 21

Summary

In India, since ancient times Tri-phal (meaning three fruits in Sanskrit) has been considered to be a combination of the following fruits:Hartak (Terminalia chebula, Retz.), malaka (Embelica officinalis Gaertn), and Vibhtaka (Terminalia belerica Roxb.). These plants are also listed in the Ayurvedic Pharmacopoeia of India. Hartak and malaka have also been used for medicinal purposes since ancient times in Japan under the Japanese names of (Kariroku) and (Annmaroku), respectively. Both have been carefully preserved as treasured drugs in the nationally important Shosoin treasure storehouse. This study attempts to clarify the description of Tri-phal in the Nvantaka, which is the second part of the Bower Manuscript (Bower Ms.), and examines the reasons why these plants were combined. This paper begins with a summary description of Tri-phal in the context of traditional Asian medicine, followed by the delineation of drug selection principles in yurveda. Tri-phal formulas in the Nvantaka are then examined. The Carakasahit (CS) treats Tri-phal as a purifier and tonic (rasyana), describing it as a formula for rejuvenation and longevity. On the other hand, the Surutasahit (SS) regards Tri-phal as having the efficacy of balancing kapha (phlegm) and pitta (bile), and also as being a medicine to promote excretion and enhance digestive functions for better nutritional intake. It is described to have an effect of curing diseases by keeping the tridhu (theree element) valance. Tri-phal is thus used as an ingredient of laxatives for diseases that result from kapha imbalance and tonic. The Agahdayasahit (AHS) considers Tri-phal to have a particular superiority among cure-all medicines with the power to dispel illness. It controls kapha and overcomes blood diseases. Tri-phal formulas found in the Nvantaka were prescribed for the treatment of abdominal tumors induced by vyu (wind) disorder as well as for coughs caused by pitta and kapha disorder. Tri-phal was also administered to facilitate nutrient absorption, regulate bowel function, and promote excretion. Tri-phal thus restores the balance of tridhu by facilitating water distribution in the body. For these reasons, the optimal combination of Tri-phal was then established to adjust kapha for most efficient purification effects.

64

50164-772015

20

*1 *1 *1

Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval: Focus on Public Release of Review Reports regarding New Drugs and Medical Devices

Kazushige Morimoto*1, Satoko Kawasaki*1 and Yasunori Yoshida*1

Received February 17, 2015

1

1993 10 1Summary Basis of Ap-proval: SBA11994 SBA No.1 21997 9 7 1 NIHS: National Institute of Health SciencesPMDEC: Pharmaceuticals and Medi-cal Devices Evaluation Center31999 11 5 14 42 2001PMDEC1999 2 NIHS 4Japan Pharmacists Education Center: JPECHP2001 Organization for Pharmaceutical Safety and Research: OPSR

2004 PMDA: Pharmaceuticals and Medical Devices Agency 20 1

2

SBA 2, 513PMRJ: Pharmaceutical and Medical Device Regulatory Science Society of Japan

HP 14PMDA /

*1 Pharmaceuticals and Medical Devices Agency (PMDA). Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013.

65

15 / 16 HP Summary Basis of Re-examination: SBRPMRJ HP14 CiNii Books 17FDAFood and Drug Administration EMAEuro-pean Medicines Agency HP18, 19

3 20

31201967 1994 SBA 2311SBA1994 4 SBA 1 2

DIDrug Information1997 4 9 5131995 9 11SBA 21PMDEC SBA 22312199620313Review Report1997 7 PMDEC OPSR GCP PMDEC

1 20 Twenty Years History of Public Release

66

Review ReportPMDEC 33141980 5 221999 3 30 3 GCP 23 4 20, 23 GCP GLP

2423

TRIPs Trade-Related Aspects of Intellectual Property Rights

2002 253151999 11 PMDEC 1999 2 NIHS 1998 12 25 3411 15 9 2020316PMDA HP2004 4 PMDA 3 2005 4

1 PMDA 2PMDA HP JPEC

67

1Historical Changes of Notice by Director of Evaluation and Licensing Division et al.

Type of Notice

Issued Date

Issued No.

Notice and its Key changes

2001/3/27 245

2007/3/30 0330022 2001 3 27 245

1999/11/11 1651

2001/9/5 1339

2002/5/29 0529003

2002/11/7 1107006

2005/4/22 0422001 2

2007/11/26 1126005

2008/8/25 0825001 500 KB1 MB10 MB

2013/3/25 0325 1 1 4CD-R DVD-RMO FD

2009/10/19 1019 3

2006/3/31 0331019

2008/10/31 1031001

2005/9/21 0921002 PMDA-HP

2009/1/30 0130001

2010/7/5 0705 5

2010/7/5 0705 1

68

OPSR19992001 1112

17 3

2 PMDA Historical Changes of Notice of by Chief Executive of PMDA

Type of Notice

Issued Date

Issued No.

Notice and its Key Changes

2005/4/22 0422004 0422001 1 2

2010/3/31 0331047

2011/3/30 0330011 1113 32003 6 30 2

2013/3/25 0325004 11 2

2013/8/6 0806016

2011/7/5 0705030

3Number of Review Reports of Approved New Drugs

Approved Year

Review Reports plus CTD1/

New Approval

Review Reports/

Partial Change

Reexamination Reports

4

English Translated Review Reports

19992 173

20002 653

2001 13 39 17

2002 40 22

2003 29 18

2004 28 18

2005 32 15

2006 72 18

2007 59 24 7

2008 56 23 5

2009 56 42 7

2010 71 37 57 8

2011 76 56 45 1

2012 83 38 35 9

2013 69 54 32 11

20143 102 38 43 01Common Technical Document2A Japansese fiscal year (from April to March of next year).3To release the information at the site of HP of JPEC (Japan Pharmacists Eduction Center).3Until on Feb 12, 20154Based on the approved year.

69

2006 PMDA HP 9072+18 8 34 3 2013 69 2013 54 32 895 420 212 2006 2008 152014 2010 15317 HP 2007 3noveltypriority 2007 7

Geninax 200 mg 2008 3 50 mg2 H5N1 H5N132321SBR1999 2627282930 5 SBA PMDA 322PMDA HP2009 10 PMDA

4Number of Review Reports of Approved New Medical Devices

1

Approved Year

Review ReportsSTED2

Reexamination Reports

4

English Translated Review Reports

2001 7

2002 1

2003 8

2004 6

2005 3

2006 8

2007 9 1

2008 7 1 1

2009 17 17 1

2010 9 9 7 2

2011 11 11 26 0

2012 16 16 15 0

2013 22 22 7 0

20143 5 4 6 01A Japansese fiscal year (from April to March of next year).2Summary Techincal Document3Until on Feb 12, 20154Based on the approved year.

70

12010 57 3245 3

4

412001 HP 3007 4PMDA 2004 3 Cypher 7 2005 9 1 2004 2009 STED: Summary Tech-nical Document 42010 7 129 STED 80 61 42 HP2007 42007 JACE 2009 12

5

CTD: Common Technical Document 5

150 CTD 1 51012 2 4000 ICH

5Scope of Public Release in New Drugs and New Medical Devices: New Approval

1

1

2CTD

6

2

1

2STED

71

2 51 PMDA

2002 5 11 12005 4

1 4 PMDA

22001 3

1

2

52 5 6 1

6Instructions on Preparing the Masked Review Report as a Draft in New Drugs

Species of Documents

Points of Instructions

Review Report

1 HP,

2

3

5

CTD

1

2 1

3

4

5

72

23

6

61 FDA1999 11 30 CDERCenter for Drug Evaluation and ResearchFDA CDER 2000 1 1 31FA CA: the Federal Advisory Committee ActFACA FOIA: Freedom of In-formation Act12

3456

78

9

FOIA 1CMC:

chemistry, manufacturing, control 2331

Frost32 2000 Public Citizen Litigation GroupFDA Approval Package 4 FOIA FDA 12

3

confidential commercial information

FDA 2014 8 13 Belsomrasuvorexant,MK-4305Oral Tablets Drug Approval Package 18 7 16 PDF Chemistry ReviewsThe Executive SummarySummary of Product AssessmentsCDRHCenter for Devices and Radiological Health332010 4 FDA 34 Premarket ApprovalPMAReview MemoApproval Order ClassPMA

73

Approval35Approval OrderSummaryLa-beling Summary PMDA Summary FOIA 62 EMABass Aronsson 362000

European Agency for the Evaluation of Medical Prod-ucts : EMEAEuropean Public Assessment ReportEPAR EU AbstractPackage LeafletSummary of Product CharacteristicsLabelling scientific discussion CPMPCommittee for Proprietary Medicinal Prod-ucts36 EMA HP 192014

Imbruvica EPAR EPAR summary for the public 8 7 WhatWhyHow

7

71 1

7FDA 1One Example of Drug Approval Package by FDA

Approved letter (s)

Other Action Letters

Printed Labeling

Summary Review

Officer/Employee List

Office Director Memo

Cross Discipline Team Leader Review

Medical Review (s)

Chemistry Review (s)

Pharmacology Review (s)

Statistical Review (s)

Clinical Pharmacology Biopharmaceutics Review (s)

Risk Assessment and Risk Mitigation Review (s)

Proprietary Name Review (s)

Other Review (s)

Administrative Document (s) & Correspondance

1Belsomra (suvorexant, MK-4305) Oral Tablets

8 EPAR 1One Example of Summary of EPAR by EMA

EPAR-Summary for the public EPAR

What is Imbruvica and what is it used for?

How is Imbruvica (Imb) used?

How does Imb work?

What benefits of Imb have been shown in studies?

What are the risks associated with Imb?

Why is Imb approved?

What measures are being taken to ensure the safe and effec-tive use of Imb ?

Other information about Imb

EPAR-Summary of the risk management planRMPfor Imb

Overview of disease epidemiology

Summary of treatment benefits

Unknowns relating to treatment benefits

Summary of safety concerns

Summary of risk mininimisation measures by safety concern

Planned post-authorisation development plan

Summary of changes to the risk management plan over time

1Imbruvica (ibrutinib)

74

WHO rational drug use 37 rational 372PMDA 4 2013 120 35 2013 81 28 2013 19 89 2013 18 2002 PMDA 73

2003 3 100 mg 2014 10 100 mg

382012 20 mg 3974PMDA HP

8

1992 40 PD-1pro-grammed cell death 1412014 7 20 mg15

75

422014 112 28,071 2008 1 43 60 444546 PMDA HP 3 HP 47IT web EMA WhatWhyHow

FDA Catherine S. Lee. DrPH,

11 SBA 1994p. 1-10

2SBANo. 11994p. 1-78

3PMDECPMDA 15201146138-50

4NIHS1999/2/18 http://web.archive.org/web/19990218171441/http:/www.nihs.go.jp/mhw/index.html

5SBA No. 21994p. 1-56

6 SBA No. 3101994p. 1-69

7 SBA No. 4 A A , A ,1995p. 1-43

8 SBA No. 5 10001995p. 1-81

9 SBA No. 61995p. 1-73

10 SBA No. 7. 1995. p. 1- 102

11 SBA No. 1. 1995p. 1-155

12 SBA No. 8, 1996p. 1-138

13 SBA No. 9 100 2001997p. 1-79

14PMRJ HPhttp://www.pmrj.jp/publications/index.html (accessed 6 Jan 2015)

15PMDAHPhttp://www.info.pmda.go.jp/info/syounin_index.html (accessed 12 Feb 6 2015)

76

16PMDAHPhttp://www.info.pmda.go.jp/info/syounin_kiki_index.html (accessed 12 Feb 2015)

17CiNii Bookshttp://ci.nii.ac.jp/books/18FDA Drug Approval Reports HPhttp://www.accessdata.

fda.gov/scripts/cder/drugsatfda/index.cfm (accessed 18 Nov 2014)

19EMA Medicines HP. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/ (accessed 18 Nov 2014)

202000273519-27

21SBA 1994p. i22SBA

2014458686-8723

2000273529-38

24tHoen E , 2000273443-65

25http://www.yakugai.gr.jp/topics/file/kouhyou_req_20020802M.pdf

26SBR No. 1 150030001997

27 No. 2 150030001997

28 No. 3 25 mg50 mg1999

29 No. 4 50 mg100 mg1999

30 No. 5 100 mg150 mg1999

31FDA/CDERFDA Guidance for industry (Draft) - Disclosing information provided to advisory committees in connection with open advisory committee meeting related to the testing or approval of new drugs and convened by CDER2000273555-61

32Frost AFDA Dissemination of clinical trial information through the internet by FDA2000273563- 67

33FDA/CDRH Transparency Web site: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/default.htm (accessed 10 Feb 2015)

34FDA NEWS RELEASE, April 19, 2010, FDA Launches Medical Device and Radiation- Emitting Product Transparency Web site http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm208969.htm (accessed 10 Feb 2015)

35FDA Medical Devices Web site: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Device ApprovalsandClearances/PMAApprovals/default.htm (accessed 10 Feb 2015)

36Bass R, Aronsson BEMEA Transpar-ency and accountability in drug regulation Dissemination of information of clinical trials thorough electronic media by EMEA2000273539-44

37The use of essential drugs2000p. 12-6

38 205 2013

39 20 10 2013482126-39

40 PD-1 2014 33101038-41

41 PD-1 201433101021

42PMDA HP. http://www.info.pmda.go.jp/approvalSrch/PharmacySrchInit?

43 2013

44 HPhttp://www.gantetsugaku.org/ (accessed 18 March 2015)

452014

46 / 2011p. 164-65

47EDITORIAL. Toward Clinical transparency. Nature Medi-cine. 201218111593

77

Summary

For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Wel-fare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices

Evaluation Center to make them available to the public.In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA)

made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA

websites.The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA.The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the What, How and Why format.Finally, future proposals for the next decade are also outlined.

78

50178-832015

*1*1

The Original Formulation for Toso-shu Tusujiu, Created by the 3rd Century Chinese Physician, Hua Tuo

Chika Mouri*1 and Masayuki Mikage*1

Received March 9, 2015

1102088108241, 2, 3a4, 53b6 16 7, 897101112

781918

1314

6 13 .

1

581 15 16, 1728436336345447318

752

*1 Graduate School of Natural Science & Technology, Kanazawa University. Kakuma-machi, Kanazawa, Ishikawa 920-1192.

79

19984 820

21a22a21b21a21a2322a .

2

2426 1

4 8 7 22b

7

80

1

581 752 11151234 984

110208

363284363

454473

284363

1 1 5 3 3 1 2 4 4 4 5 2 6 2 3 8 6 6 5 7 7

7 8

Rhubarb Atractylodes rhizome Cinnamon bark Platycodon root Zanthoxylum fruit Processed aconite root Smilax rhizome

81

16, 1722c

23 150

10 0.06 g 27, 28100 0.6 g .

3

10029500 3018423132

33a33b33c33c, 34, 3533c33d36a36b34.

82

0.6 g 9 g10.8 g 9 g 3.6 g 7.2 g .

.

1 1694

21884-1888http://dl.ndl.go.jp/info:ndljp/pid/898162/896http://dl.ndl.go.jp/info:ndljp/pid/898162/897accessed 30 Jan 2015

31988a p. 21bp. 1-21

420134233-68

520103489-509

61959p. 373-74

71788http://edb.kulib.kyoto-u.ac.jp/exhibit/kichosearch/src/fuji4141.htmlaccessed 30 Jan 2015

8197534158-9191662

10http://chinese.dsturgeon.net/text.pl?node=51807&if=gb accessed 30 Jan 2015

11 4671987p. 3-4121971

pp130-313 III

199141431-52142011p. 12-3 151993p. 138161977 386390

327-48171963p. 135-618 11

198924137-46191964p. 129-

30201993p. 239211956a

p. 147150-1b p. 42-322 324

1978ap. 21-38bp. 28cp. 35-623

1983p. 180-324

1982p. 8725

1990p. 20 26

1979p. 7527

1978p. 56-7228

2001514670-829 223

1983-1986p. 8330

1972p. 5231

1842

322008p. 224-533

1992ap. 17-27bpp79-81cpp86-91dp85341995p. 275-735 1942p. 21636

1986ap. 25-630-13640-2bp. 36

83

Summary

The original formulation for Tusujiu, which Japanese people still consume on the morning of January 1st, was created by Hua Tuo, but has not been studied in detail. The book Huatuo Shenyi Bizhuan, found in 1918, describes a concoction, Biyijiu, that shows great similarity to the current Tusujiu; the ingredients for Biyijiu being rhubarb, atractylodes rhizome, cinnamon bark, platycodon root, zanthoxylum fruit, processed aconite root and smilax rhizome. The procedures for preparing and drinking it are to pound the ingredients and then put them into a silk bag dyed with madder. During the daytime of the last day of the year, hang the bag in a well to soften the powder. Take the bag out early in the morning of the next day, the first day of the year. Heat the bag in fermented liquor until simmering. Drink the liquid with all family members, doing so while facing east. If one person drinks it, there will be no disease in the family. If the whole family drinks it, there will be no disease in their neighborhood in an area of one square li. In this study, to determine the original formulation for Tusujiu, we examined a number of ancient medical texts from the 3rd to the 13th century that discuss Biyijiu and Tusujiu. As a result, we concluded that Biyijiu is likely to be the original formulation developed by Hua Tuo.

84

50184-882015

10

*1

Pharmaceutical Regulations in the Japanese Hospitals in 1880s and the Case of a Scholar of Pharmacology in Oita Prefecture

Masahiko Goino*1

Received February 22, 2015

123 2006 45, 623 1 1890 2320 10

http://kindai.ndl.go.jp/1900 1937 12

10 1880

*1 Tokyo-Kaido Hospital, Department of Pharmacy. 1-4-5 Suehiro-cho, Ome, Tokyo 198-0025.

85

11885 18

1872 5 11 7

1872 5 3 14 3 5 8

21878 119

31881 14 23 1880 13

1 29

102 1 8

9

11

31241883 16

1 13 12

13 13 2

2 4

5 14

3

1

86

2 13 -14

1

1872 5

3 5 5-14

1874 7 66 :

71

1878 11

1880 13

1880 13

1889 22 19 ;

87

12 10 15

4 13 2 9

1651751937 12

12

18 1

10 1880 123 3 2014 3

19 1880 13 10

1871 41872 51881 141874 7 71 66

10 22 1938 1320 1971 4621 26 236 22 2

1988 63100 1996 8 8 104 25 2

COI COI

119773263-79

88

2200843167-78

31872 5 2012472144-8

4 2006 2006412100-5

5200742165-83

62008432192-8

71885p. 20-30

81885p. 62-6

9 9 1878159 -164

101884p. 258111884p. 260121884

13

188311 14

188314 -15 15

18834 16

18836 17

188344 18

1937p. 1631920

20013719-14

201938p. 83-9211971p. 12422 50

200843179-83

Summary

In the 1870s, various provisions existed regarding pharmacists working at Japanese military hospitals. And in the decade of the 1880s, some hospitalsin Tokyo and Oita implemented them. These provisions gave pharmacists the right to challenge doctors prescriptions and provide patients with medicine-related informa-tion. In Oita Prefecture, patients could have their prescriptions filled outside of the hospital. This paper ex-amines the case of one scholar of pharmacology who worked in Oita Medical School Hospital.

89

50189-932015

*1*2*3*4*2*2*2 *2*5*5*1*1*1

Visualization for Traditional Quality Management Techniques Characterization Method for Spikenard of INUBUSHI SEIYAKU Established

in the Edo Period

Ken Ito*1*2, Soichiro Inubushi*3, Takafumi Moriwaki*2, Kazuhiro Matsunaga*2, Kyoko Takahashi*2, Takahiro Ueda*2, Setsuya Hashizume*2, Hiroaki Takemoto*5, Yoshinori Kobayashi*5, Tomoe Ota*1, Seiko Nakamura*1 and Hisashi Matsuda*1

Received March 16, 2015

1

118 181818302 1 14

3 144Nardostachys chinensisN. chin-ensis calarene 467 calarene 8

*1

*2*3*4*5

Kyoto Pharmaceutical University, Division of Medicinal Chemical Sciences Pharmacognosy. Misasagi-Shichonocho 1, Yamashinaku, Kyoto 607-8412.The Museum of Osaka University. 1-13 Machikaneyama-cho, Toyonaka, Osaka 560-0043.INUBUSHI SEIYAKU. 64-6 Higashihoji, Higashinakatomi, Aizumi, Itano, Tokushima 771-1220.Tokushima Castle Museum. 1-8 Jyonai, Tokushima-cho, Tokushima 770-0851.School of Pharmacy, Kitasato University. 5-9-1 Shirokane, Minato-ku, Tokyo 108-8641.

90

494

2

21

2223 20 mL n-hexane 1 3 1.0 g 24 0.5 mg/mL GC MS GCMS-QP2010SEShimadzu Corporation, Kyoto, JapanColumn : fused silica capillary column HB-5Agi-lent Technologies, Inc., Santa Clara, CA, USA30 m0.25 mm0.25 m film thickness ; column temperature : 40 3 4030010 /min 3005 injector : 200carrier gas : helium50.9 cm/min ; column head pressure : 111.6 kPa ; injection volume : 1 L ; ionaization energy : 70 eV calarene N. chinensis NMR 8TICTotal Ion Current Chromatogram calareneRTRetention Time14.7 min

3

31 3 3

1ab

91

850. g 132.5 g 84.432

2N. chinensis 2.0 cm

2.07.0 cm 0.5 cm 33

1.0 g 34.0 mg 13.3 mg 15.7 mg

2

abc

3 GC-MS GC-MS calarene TICTotal Ion Current Chromatogramabc

92

GC-MS 3 calarene TIC 37.9 % 22.7 % 30.0 % 100 %

4

2.0 cm 0.5 cm 15 % 1.0 g 2.2 2.6 retronasal olfaction10, 11 14 9 calarene 8 calarene 26 % 67 % 2.8 4.3 cala-rene

5

GC-MS

11965p 461-22

200652125-36

3http://inubusiseiyaku.com/03keishintan.htmlaccessed 12 Mar 2015)

42004p 206-135Tanaka K, Komatsu K. Comparative study on volatile com-

ponents of Nardostachys rhizome. J. Nat. Med. 2008 ; 62 (1) : 112-6

6Han Y, Xiao D, Xiang Y, Ye L, Cheng C. Study on the vola-tile oil of Nardostachys chinensis. Zhong Yao Cai. 2000 ; 23 (1) : 34-5

7Zhang J, Qiang CC, Li WJ, Liu LJ, Lin XX, Cheng YJ et al. Effects of Nardostachys chinensis on spontaneous ventricu-lar arrhythmias in rats with acute myocardial infarction. J Cardiovasc Pharmacol. 2014 ; 64 (2) : 127-33

8Takemoto H, Ito M, Shiraki T, Yagura T, Honda G. Sedative effects of vapor inhalation of agarwood oil and spikenard ex-tract and identification of their active components. J Nat Med. 2008 ; 62 (1) : 41-6

91986p 50-110

93

2007458564-911Small DM, Gerber JC, Mak YE, Hummel T. Differential neu-

ral responses evoked by orthonasal versus retronasal odor-ant perception in humans. Neuron. 2005 ; 47 (4) : 593-605

Summary

INUBUSHI SEIYAKU, a Japanese pharmaceutical company established in 1807, manufactures KEISHIN-TAN. This is an original drug developed by the company, and consists of 14 exotic natural medicines, spike-nard, oriental bezoar, musk, agarwood, etc. It has been used for adjusting the autonomic nervous system and physical conditions. We studied the original methods of the traditional quality management techniques hand-ed down within INUBUSHI SEIYAKU in selecting the appropriate spikenard (Nardostachys chinensis) for medicinal use. Currently, spikenards are mainly used as incense rather than medicine. KEISHIN-TAN is a rare case in that the bulk powder of the spikenards is used for pharmaceutical products in Japan. We exam-ined the morphological characteristics and made an analysis of the component of spikenards selected by tra-ditional methods. The raw material of the spikenards was purchased from the Japanese market, and was classified into two categories-superior, fit for medicinal use and defective, to be discarded-by traditional methods of INUBUSHI SEIYAKU. The methods of the characterization of the spikenard by INUBUSHI SEIYAKU were investigated. As a result, only thick spikenard roots over 2.0 cm in length and approximately 0.5 cm in diameter were found to be used, and the total weight of the superior was only 15% of the raw ma-terial. By comparing the weights of hexane extracts and GC-MS analyses, the content of calarenemain sed-ative compound in spikenardsin the superior material was 2.8 times higher than the raw material and 4.3 times higher than the defective material. The ways to devise how to enhance the pharmacological effects of spikenards may be contained in this method. These results revealed the traditional spikenard selection crite-ria, and may show the indications of using spikenard or its compounds for medicinal purposes.

95

2014 2

2014 11 22 12:10-13:10 2014

2

18 12014 6 30 Vol.49,No.120141980201020042013 500 330 22015 6 3 20152015 2015 11 21 1 2 22 4 4 2 80

5Web Vol.482014Web Web Web 6 602014 11 18 320 1 5,000 6 4 2 1 2015 9 72014 9 8 2013 340 2013 400 2 100 12 75% 2 9 2004 11 2014 5

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2015 4 18 12:30-13:30 2 33

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123 1 60

602014 11 18 320 2015 3 92 1,380,000 4052 2015 9

4 2 2015 2 2 2013 2 76221175 46 60 62 70 48 80 36 60 66% 40 14 6% 2

5 3 2015 1 80 2 1 2 2 3 4

2 45 8

62016

7

2015 4 18 14:00-15:50 2 47 2014

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12014

Vol.49No.1 164 500 1980201020042013Vol.49No.276 400

97

22014 No.71No.72No.73 36 550 2014 1 3

3 2014 1

42014

11

2014 6

2 60

21

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2014 4 19

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