1

FARMAKOGNOSI
2
MANFAAT STANDARDISASI
3

MENJAMIN KESERAGAMAN PRODUK

dalam
KUALITAS, KEAMANAN, DAN KHASIAT
(Quality, Safety, Efficacy)
 KRITERIA OBAT
4

KUALITAS / Quality: Tidak Rusak

Uji Identitas, Kuantitatif,
Cemaran, Stabilitas
AMAN / Safety : Tidak Toksik
Uji Toksisitas
KHASIAT / Eficaccy : Bermanfaat
Uji Praklinik & Klinik
 KONSEP ANALISIS BAHAN ALAM
5

JENIS
 Pengujian Kebenaran Bahan KHASIAT
JUMLAH/KADAR
 Pengujian terhadap senyawa aktif & senyawa marker
 Berhubungan dengan dosis
CEMARAN/KONTAMINAN AMAN

 Harus sesuai dengan persyaratan (tidak boleh melebihi batas

maksimum)
 Pengujian logam berat, cemaran mikroba, dll

KUALITAS
BAHAN BAKU
6

AKTIVITAS
vs
KANDUNGAN KIMIA
MASALAH TUMBUHAN OBAT
7

AKTIVITAS BIOLOGIS
vs
KANDUNGAN KIMIA
vs
FAKTOR-FAKTOR YANG MAMPENGARUHI
 8

STANDARDISASI
Secara Kimia 
Senyawa Marker
Secara Farmakologi
 Senyawa Bio-
Marker

STANDARDISASI
 Standardization of Herbs
9

1. If phytopharmaceuticals want to be regarded as rational

drugs, they need to be standardized and pharmaceuticals
quality must be approved
2. In pharmacological, toxicological & clinical studies with
herbal drugs, their composition needs to be well
documented in order to obtain reproducible results
3. WHO has recognized this problem and has published
guidelines to ensure reliability and repeatability of research
on herbal medicines
4. This concept should be followed not only in research, but
also in the production and application of
phytopharmaceuticals
Quality Control Methods
10
 Acknowledgment
 Preface to the first edition (1998)
 Preface to the updated edition
 Note to the reader
 1. General notices
 2. Powder fineness and sieve size
 3. General advice on sampling
 4. Determination of foreign matter
 5. Macroscopic and microscopic examination
 6. Thin-layer chromatography
 7. Determination of ash
 8. Determination of extractable matter
 9. Determination of water and volatile matter
 10. Determination of volatile oils
 11. Determination of bitterness value
 12. Determination of haemolytic activity
 13. Determination of tannins
Quality Control Methods
11
 14. Determination of swelling index
 15. Determination of foaming index
 16. Determination of pesticide residues
 17. Determination of arsenic and toxic metals
 18. Determination of microorganisms
 19. Determination of aflatoxins
 20. Radioactive contamination
 21. Culture media & strains used for microbiological analysis
 22. Specifications for adsorbents for use in TLC
 23. Reagents and solutions
 References
 Selected bibliography
 Glossary
 Annex : WHO good practices for pharmaceutical QC
 Standardisasi Obat Bahan Alam
12

1. KEBENARAN BAHAN
Penetapan Parameter Spesifik
 Khas untuk tiap-tiap tanaman
2. KEMURNIAN
Penetapan Parameter Non-Spesifik
(terkait dengan senyawa lain yang tidak diinginkan)
 Tidak khas / umum untuk semua tanaman
3. KADAR KANDUNGAN KIMIA
Kandungan senyawa aktif ataupun senyawa marker
 Standardisasi Ekstrak & Obat Bahan Alam
13

Parameter Spesifik  Senyawa Identitas

 Parameter Organoleptik
 Senyawa Terlarut dlm Pelarut Tertentu (Kadar Sari): larut air & etanol

Parameter  Parameter Susut Pengeringan

Non Spesifik  Parameter Bobot Jenis
 Kadar Air
Kemurnian &  Kadar Abu
Kontaminasi  Sisa Pelarut
 Residu Pestisida
 Cemaran Logam Berat
 Cemaran Mikroba
 Cemaran Kapang, Khamir dan
Aflatoksin

Kadar Kandungan
 Kandungan Flavonoid Total
Kimia  Kandungan Senyawa Aktif
 Kandungan Senyawa Marker Spesifik
14
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