SBOA Obat Herbal

7/25/2019 SBOA Obat Herbal

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MENGAPA STANDARISASI

BAHAN OBAT ALAM HARUSDILAKUKAN?

80% PENDUDUKDUNIA

MENGGUNAKANOBAT HERBAL

SECARA EMPIRIS

BERAGAM JENIS

SENYAWAMETABOLIT

DALAM OBATHERBAL

TIDAK MENJUALSECARA EKONOMIS

FITOFARMA

KA



A• sediaan obat bahan alamyang telah dibuktikan

keamanan dan khasiatnyasecara ilmiah dengan ujipraklinik dan uji klinik,

bahan baku dan produk jadinya telah di standarisasi.



Botani farmasi

Farmakognositokimiakimiakimia

farmaceutikafarmaceutika

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SEDIAANSEDIAAN

GALENIKGALENIK

OBAT HERBALOBAT HERBAL

TERSTANDARTERSTANDAR

F & ' ( F A) " A* A

??

OBAOBAT TRADT TRAD

JAMJAM



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+ources of atural Products

• Plants -/,/// di0erent plant species inthe 1orld2

• &nsects 3/ million species2

• Fungi 4, million2• Algae 4, million2• (ther Prokaryotics 4, million2Data From ). 5erpoorte, DD' 46672, 3, -3-8-372

Endogenous "icroorganism 99992• "arine (rganism 9992• 5ertebrates and &n:ertebrates 992



4. (bat tradisional adalah bahan atau ramuan bahan yang berupa

bahan tumbuhan, bahan he1an, bahan mineral, sediaan sariangalenik2 atau campuran dari bahan tersebut, yang secara turun8temurun telah digunakan untuk pengobatan berdasarkanpengalaman.

-. ;amu adalah obat tradisional &ndonesia.

3. (bat herbal terstandar adalah sediaan obat bahan alam yangtelah dibuktikan keamanan dan khasiatnya secara ilmiah denganuji praklinik dan bahan bakunya telah di standarisasi.

<. Fitofarmaka adalah sediaan obat bahan alam yang telahdibuktikan keamanan dan khasiatnya secara ilmiah dengan uji

praklinik dan uji klinik, bahan baku dan produk jadinya telah distandarisasi.

. +ediaan galenik adalah hasil ekstraksi simplisia yang berasal daritumbuh8tumbuhan atau he1an.

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Safety, efficacy and quality

• Lack of research methodology• Inadequate evidence-base for TM/CM

thera!ies and !roducts

• Lack of international and national standardsfor ensuring safety, efficacy and quality

control of TM/CM thera!ies and !roducts

• Lack of adequate regulation and registrationof herbal medicines

• Lack of registration of TM/CM !roviders

• Inadequate su!!ort for research



CC"SS

• Lack of data measuring access levels andaffordability

• #eed to identify safe and effective

thera!ies and !roducts

• Lack of official recognition of role of

TM/CM !roviders

• Lack of coo!eration bet$een TM/CM!roviders and allo!athic !ractitioners

• %nsustainable use of medicinal !lant

resources



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&'(



&'(

)uidelines



)uidelines for the regulation of herbal

medicines in the South-"ast sia *egion

These guidelines aim to !ro!ose to member states a frame$ork for

facilitating the regulation of herbal medicines/ !roducts used in

traditional medicine

They cover the follo$ing issues+

• Classification of herbal medicines• Minimum requirements for assessment of safety of herbal

medicine

• Minimum requirements for assessment of the efficacy of herbal

medicines

• uality assurance of herbal medicinal !roducts

• harmacovigilance of herbal medicinal !roducts

• Control of advertisements of herbal medicinal !roducts



uality Control Methods for Medicinal

lant Materials

This manual describes a series of tests for assessing thequality of medicinal !lant materials. These tests aredesigned !rimarily for use in national drug qualitycontrol laboratories in develo!ing countries and

com!lement those described in The International Pharmacopeia.

It !ertains to the follo$ing

• o$der fineness and sieve si0e

• Macrosco!ic and microsco!ic !ro!erties

• 1etermination of ash, e2tractable matter, volatile oils,bitterness value, hemolytic activity, tannins, !esticideresidues, radioactive contamination etc.

&'( ) id li f t it i f



&'( )uidelines on safety monitoring of

herbal medicines in !harmacovigilance

systems

Safety of herbal medicine is an im!ortant !ublic healthissue. The guidelines stresses u!on+

•The im!ortance and !rocess of monitoring the safety of

herbal medicine $ithin the !harmacoivigilance system

•Standard definitions of terms related to!harmacovigilance and safety monitoring of herbalmedicine

•Challenges in monitoring the safety of herbal medicine

•Need for good communication for ensuring successfulsafety monitoring

&'( ) id li d i lt l d



&'( )uidelines on good agricultural and

collection !ractices 3)C4 for medicinal !lants

These guidelines are intended to !rovide technical

kno$ledge on obtaining medicinal !lant materials of goodquality for the sustainable !roduction of herbal !roducts

classified as medicines.

They a!!ly to the follo$ing +

• Identification, authentication, cultivation and harvest of medicinal !lants

• )ood collection !ractices for medicinal !lants

• Common technical as!ects of good agricultural !racticesfor medicinal !lants in terms of !ersonnel, !ackaging,

storage and trans!ortation.

• *elevant issues of ethical/ legal considerations and

research

)eneral g idelines for methodologies on



)eneral guidelines for methodologies on

research and evaluation of traditional

medicine

These guidelines have been develo!ed to !romote the

!ro!er use and develo!ment of traditional medicine

and relate to s!ecific issues of methodologies for+

• research and evaluation of herbal medicines

• research and evaluation of traditional !rocedure 5

based thera!ies

• Clinical research norms• (ther issues and considerations of ethics, education/

training and surveillance systems.



&'( )lobal

Strategic

1irections

&'( Traditional Medicine Strategy+



•


(b6ectives, Com!onents and "2!ected (utcomes

(b6ectives Com!onents "2!ected outcomes

(LIC7+

Integrate

TM/CM $ith

national health

care systems,as a!!ro!riate,

by develo!ing

and

im!lementing

*ecognition of TM/CM •

'el! countries to develo!

national !olicies and

!rogrammes on

TM/CM

Increased government

su!!ort for TM/CM,

through com!rehensive

national !olicies on

TM/CM*elevant TM/CM

integrated into national

health care system

services

nationalTM/CM

!olicies8 and

!rogrammes

rotection and !reservationof indigenous TM

kno$ledge relating to health

'el! countries to develo!

strategies to !rotect their

indigenous TM kno$ledge

Increased recording and

!reservation of indigenous

kno$ledge of TM, including

develo!ment of digital TM

libraries



•

•

•




S9"T7, "vidence-base for Increased access to and e2tent of

"99ICC7 #1 TM/CM Increase kno$ledge of TM/CM through

%LIT7+ access to and e2tent of net$orking and e2change of

romote the kno$ledge of the safety, accurate information

safety, efficacy efficacy and quality of Technical revie$s of research onand quality of TM/CM, $ith an use of TM/CM for !revention,TM/CM by em!hasis on !riority treatment and management of e2!anding the health !roblems such common diseases and conditionskno$ledge-base

on TM/CM, and

by !rovidingguidance on

regulatory and

quality assurance

as malaria and

'I:/I1SSelective su!!ort for clinical

research into use of TM/CM for

!riority health !roblems such as

malaria and 'I:/I1S, and

common diseases

standards



•

•

&'( Traditional Medicine Strategy +


(b6ectives Com!onents "2!ected outcomes*TI(#L %S"+ ro!er use of TM/CM ;asic training in

romote by !roviders Increase commonly used TM/CM

thera!eutically ca!acity of TM/CM thera!ies !ractitioners

sound use of !roviders to make

a!!ro!riate

TM/CM by

!roviders and

consumers

!ro!er use of TM/CM

!roducts and thera!ies ;asic training in !rimaryhealth care for TM

ractitioners

ro!er use of TM/CM

by consumers

Increase ca!acity of consumers to make

informed decisions

about use of TM/CM

!roducts and

thera!ies

•Reliable information for

consumers on !ro!er use of

TM/CM thera!ies

•Improved communication

bet$een allo!athic !ractitioners

and their !atients concerning

use of TM/CM



quality control of herbal

quality of TM/CM




S9"T7, *egulation of herbal medicines • #ational regulation of herbal

"99ICC7 #1 Su!!ort countries to establish medicines, including

%LIT7+ effective regulatory systems for registration, established and

romote the registration and quality im!lemented

safety, efficacy assurance of herbal medicines • Safety monitoring of herbaland quality of medicines and otherTM/CM by TM/CM !roducts ande2!anding the thera!ieskno$ledge-base

on TM/CM,and by !roviding

guidance on

regulatory and

quality assurance

standards

)uidelines on safety, efficacy • Technical guidelines and

and quality 1evelo! and methodology for evaluatingsu!!ort im!lementation of safety, efficacy and quality of

technical guidelines for TM/CM

ensuring the safety, efficacy and • Criteria for evidence-based

data on safety, efficacy andmedicines and other TM/CM

!roducts and thera!ies thera!ies




•

•

•




CC"SS+ *ecognition of role of Criteria and indicators, $here

Increase the TM/CM !ractitioners in !ossible, to measure cost-

availability and health care romote effectiveness and equitable access

affordability of recognition of role of to TM/CM

TM/CM, as

a!!ro!riate,$ith an

em!hasis on

TM/CM !ractitioners in

health care by encouraginginteraction and dialogue

bet$een TM/CM

Increased !rovision of

a!!ro!riate TM/CM through

national health services

access for !oor !ractitioners and allo!athic Increased number of national

!o!ulations !ractitioners organi0ations of TM/CM

!roviders

rotection of medicinal

!lants romote

sustainable use and

cultivation of medicinal

!lants

•Guidelines for good agriculture

!ractice in relation to medicinal !lants

•Sustainable use of medicinal !lant

resources



INDONESIA

HERBAL

MEDICINE



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;road %se and !!eal



;road %se and !!eal

In many develo!ing

and develo!ed

countries as often

stated in government

re!orts the ma6ority

of the !o!ulation

continues to use TM

to meet its !rimaryhealth care needs.

ercentage of o!ulation used CM



ercentage of o!ulation used CM

tleast (nce

Sources: Fisher P !ard "# $%%%& 'ealth Canada# ())$# !orld 'ealth *rgani+ation# $%%,-.#,#/

Commonly used TM/CM thera!ies



Commonly used TM/CM thera!ies

and thera!eutic techniques

More and More Countries are



*egulating 'erbal Medicines

Source: !orld 'ealth *rgani+ation# $%%,0$ and data collected b1 !orld 'ealth *rgani+ation during period $%%%–())$-



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