The opinions expressed in the presentation and on the following slides are solely those of the speaker and are not necessarily those of CDE and/or TFDA.

() () ()

() () ()

(I&II)

(III)

(/)

-/ Aristolochic acid nephropathy (AAN) * (~1992) Aristolochia fangchi ()** Stephania tetrandra ()

Kidney International (2008) 74, 158169***

Phase I/II () ()Phase III

(GACP)Planta Medica (2006) 72, 458467Rehmannia glutinosa((gram))

(GACP)Planta Medica (2006) 72, 458467Rehmannia glutinosamethanol/water fractionGC-MS ()

(GACP)Phase I/II: () Phase III () ()

Planta Medica (2006) 72, 458467Rehmannia glutinosamethanol/water fractionGC-MS

Planta Medica (2006) 72, 458467Rehmannia glutinosamethanol/water fractionGC-MS

Phase I/II: () (): : //:

Phase III: /: //:

Phase I/II::1. 2. /3. 4. () ()/5. 6. 7. 8. ()9.

Phase I/II () :1. 2. /3. 4. 5. () ()/6. 7. 8. ()

Phase III(; CoA)(;)(; CoA)(;)

(; CoA)

Phase III:(1) (2) /(3) (4) (5) (6) (7) (8) (9) ()(10)

Phase III:(1) (2) /(3) (4) (5) () ()/ (6) (7) (8)

Phase III:(9) (10) (11) (12) ()(13) (14) ()(15) ()(16) (pyrrolizidine alkaloids)(17)

Phase III:(1) (2) /(3) (4) () () /(5) (6) (7) (8) (9)

Nuclear magnetic resonance (NMR) spectroscopy

Polygonum cuspidatumPolygonum multiflorumPlanta Medica (2011) 77, 8186

Phase I/II-Phase IIIPharmacognosy Review (2011) 5, 4854

Rapid resolution liquid chromatography (RRLC) analysis of Shuang-Huan-Lian preparationsJournal of Pharmaceutical and Biomedical Analysis (2011) 54, 265272Flos LoniceraeRadix ScutellariaeFructus ForsythiaeRaw medicinal herbs

Journal of Pharmaceutical and Biomedical Analysis (2011) 54, 265272Raw medicinal herbsCommercial SHL oral solution

Journal of Pharmaceutical and Biomedical Analysis (2011) 54, 265272123456Flos Lonicerae herbal liquid extractAfter 48 h storage at room temperaturepH 3.5pH 7.0pH 11.0Isomerization213

Journal of Pharmaceutical and Biomedical Analysis (2011) 54, 265272123456Flos Lonicerae herbal liquid extractAfter 48 h storage at room temperaturepH 3.5pH 7.0pH 11.0Isomerization546

()

1. (2009)2.EMA: Points to Consider on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin (2002)3.EMA: Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products (2006)4.EMA: Guideline on Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products (2006)5.EMA: Guideline on Quality of Combination Herbal Medicinal Products/Traditional Herbal Medicinal Products (2008)6.FDA: Guidance for Industry-Botanical Drug Products (2004)7.WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants (2003)8.WHO Monograph on Good Agricultural and Collection Practices (GACP) for Artemisia annua L. (2006)9.WHO Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues (2007)