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Standardisasi Obat Bahan Alam

Standardisasi Obat Bahan Alam. Can herbal extracts and herbal medicinal products be “ essentially similar”?. Standardisasi. Definisi. EU Standardisation all measures which are taken during the manufacturing process and quality control leading to a reproducible quality

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Standardisasi Obat Bahan Alam

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  1. Standardisasi ObatBahanAlam

  2. Can herbal extracts and herbal medicinal products be “ essentially similar”?

  3. Standardisasi

  4. Definisi EU Standardisation all measures which are taken during the manufacturing process and quality control leading to a reproducible quality Standardisation means the adjusting of the herbal drug preparation to a defined content of a constituent or a group of substances with known therapeutic activity, respectively by adding excipients or by blending herbal drugs or herbal preparations

  5. STANDARDISASI Sangat penting, hanya diterapkan untuk ekstrak - Kualitas reprodusibel - Membandingkannya terhadap produk dengan senyawa baku yang dikenal atau menyatakan jumlah minimum senyawa atau beberapa senyawa atau golongan senyawa

  6. Standardisasi Bahanbakuharusmemenuhikriteriatertentu Menjaminmutudankhasiat Kualitassediaanmemilikinilaitetapdanreprodusibel Menentukanjumlah minimum darisatuataubeberapakomponen yang terkandung Rangkaian parameter, prosedurdancarapengukuranberhubungandenganmutukefarmasian

  7. Mutu Memenuhisyaratstandar (Kimia, biologi, farmasi) termasukjaminanstabilitassebagaiprodukkefarmasian Produkakhir (obat, ekstrak, atauprodukprodukekstrak) mempunyainilai parameter yang konstan

  8. Parameter mutuekstrak • Parameter standarumum (non spesifik) • Parameter standarspesifik

  9. Parameter non spesifik • Susutpengeringan • Kadaabu • Kadar air • Sisapelarut • Residupestisida • Cemaranlogamberat • Cemaranmikroba

  10. Rendemen • Jumlahgolongansenyawaterekstraksidenganpelarut yang digunakan • Mengacupadabukustandar yang ada • Tergantungdarimetodeekstraksi yang digunakan (sinambung/ tidak) danpelarut yang digunakan

  11. Kadar air • PenetapandengancaradestilasiatauTitrasi Karl-Fischer • Jikasampeltidakmengandungminyakmenguap, makasusutpengeringan (Loss on drying) samadengankadar air • Susutpengeringanmenggunakanpemanasanpada 100-105oC sampaiberatkonstan • Batas kadar air bervariasitertinggi 15%

  12. Kadar Abu 2- 4 g sampeldipijardalamwadahkrusiblepadatemperaturrendah (450oC) Jikakarbonmasihtersisa, karbondipisahkandenganmelarutkandi air. Selanjutnyaresidudipijarkemlaidenganpenambahanasamsulfatdandipijarpada 600oC

  13. KontaminasiBakteria Produktidakharussteril, tapiharusbebasdaribakteri. SebagaiindikatorbakteripatogendigunakanE. coli Apatogenikdiijinkandenganbataskurangdari 103bakteria/g untuksediaan oral Padabahanbaku 104bakteria/ g atau 100 untukkapangdankhamir

  14. Batas residupestisida

  15. KontaminasiBakteria Produktidakharussteril, tapiharusbebasdaribakteri. SebagaiindikatorbakteripatogendigunakanE. coli Apatogenikdiijinkandenganbataskurangdari 103bakteria/g untuksediaan oral Padabahanbaku 104bakteria/ g atau 100 untukkapangdankhamir

  16. Batas mikroba (Farmakopeeropa 2002) • Maksimum 105 / g atau ml untukmikrobaaerob, neliputi: • - maks 103/ g atau ml untukkapangdankhamir • - Maks 103/ g atau ml untukenterobakteria E. coli tidakterdeteksi per g atau ml Salmonella sp tidakterdeteksi per 10 g atau ml

  17. KontaminasiZatAsing Sampelmudahterkontaminasibahanpasir, batuataulogam, kotoranbinatang, seranggadanjamur • 100-500 g sampeldisebarpadakertasdandibantudengankacapembesardiambilbahanasingdandihitungpersentasizatasing

  18. Parameter spesifik • Identitasekstrak • Organoleptikekstrak • Kadar senyawaterlarutpadapelaruttertentu

  19. Identitasekstrak Deskripsitatanamaekstrak, namalatintumbuhan, bagiantumbuhan yang digunakan, senyawaidentitas yang menjadipetunjukaspesifik

  20. Kasus Ada 5 daun : Daun Saga DaunAsamJawa DaunMeniran DaunPutriMalu DaunPetaiCina Bagaimanamengidentifikasiataumemastikanvaliditasdaun yang diinginkan ?

  21. Ujikandungankimiaekstrak • Polakromatogram • Kadar total kandungankimia • Kadar kandungankimiatertentu

  22. Standardisasi Salahsatupamaterkandungankimia • Polakromatogram • Total golongankandungankimia • Kadar kandungankimiatertentu (senyawaidentitas)

  23. Bahanbaku • Tanaman • Simplisia • Ekstrak

  24. Tipe Ekstrak Ekstrak Terstandar (Tipe A): ekstrak distandardisasi terhadap senyawa berkhasiatnya Ekstrak Terkuantifikasi (Tipe B): ekstrak distandardisasi terhadap kandungan yang ikut berperan dalam khasiatnya Ekstrak Lain (Tipe C): ekstrak yang distandisasi terhadap senyawa penuntun (secara farmakologi tidak diketahui)/ marker

  25. Esktrak Terstandar Daun digitalis (Digitalis folium), glikosida digitalis sampai 5% Ekstrak kering senna: distandardisasi mengandung 5,5- 8,0% glikosida hidroksiantrasene, dihitung sebagai sennosid B Ekstrak kering daun belladonna (Belladonnae Folium dari Atropa belladona) distandardisasi mengandung 0,95-1,05% alkaloid dihitung sebagai hiosiamin

  26. Ekstrak Terkuantifikasi Ginkgo biloba L, daun, kandungan: Flavonoid (0,5-1%): flavon dan flavonol glikosia, biflavonoid, glikosida flavonol terasetilasi Terpen lakton (0,03-0,25%) Kandungan yg tidak diinginkan (polifenol, polisakarida, asam ginkgolat) direduksi  flavonoid glikosida (16-26%) dan terpen lakton (5-7%) Hypericum perforatum L, bagian di atas tanah (herba St John`s wort)

  27. Ekstrak Lain Senyawa yang bertanggung jawab terhadap aktifitas tidak diketahui diperlukan marker untuk kualitas Crataegus, bagian di atas tanah (Crataegi folium cum flore, howthorn) Passiflora incarnata L, bagian di atas tanah (Passiflorae herba, passion flower): Kualitatif KLT dengan baku rutin atau hiperosida Kuantitatif : spektrofotometri atau KCKT sidik jari

  28. Fitoekuivalen

  29. Ginkgo biloba

  30. Marker

  31. Marker Marker substances or groups of marker substances are chemically defined constituents of herbal drugs, herbal drug preparations and herbal medicinal products which, according to the state of scientific knowledge, do not contribute to contribute to therapeutical activity. They only serve analytical pruposes

  32. Two categories of markers Markers which are caracteristic for respective genus or family of the plant, and are therefore suitable for identification tests and assay (e.g.. batch-to-batch control) Marker which occur ubiquitously in plants. They can only be utilised for quantification and do not provide further knowledge regarding the quality of the herbal drug or the herbal drug preparations

  33. General categories of the constituents

  34. Markers Serve analytical control purposes at the following steps of manufacture: • Identification and purity tests • Batch-to-batch control • Determination of the extraction rate • Validation of the manufacturing conditions • Stability testing • Evidence of batch-to-batch conformity

  35. Markers Valerinic acid are specific constituents of V. officinalisand thus elligible for distingushing the herbal drugs from Radix V. edulis(Mexicanae) as well as Radix V. walichii

  36. Marker Marker substances can be used for stablity testing if therapeutically active or active constituents are not known. To prove batch-to-batch confromity over the whole shlef-life, additional fingerprint chromatogram must be performed in different range of polarity

  37. Extraction of an unknown sample Example: Kumis Kuching Polar mobile phase: chloroform, methanol,water (70:30:4) For saponines and lignanes 1 2 3 4 5 6 7 8 9 10 11 12 Extraction solvent: 1: heptane; 2: toluene; 3: MTBE; 4: DCM; 5: chloroform; 6: acetone; 7: ethanol; 8: methanol; 9: ethanol-water(7:3); 10: methanol-water (8:2); 11: methanol-acetic acid (9:1); 12: methanol-ammonia 25% (8:2).

  38. Extraction of an unknown sample Example: Kumis Kuching Ethyl acetate, acetic acid, formic acid, water 100:11:11:27 For flavonoids 1 2 3 4 5 6 7 8 9 10 11 12 Extraction solvent: 1: heptane; 2: toluene; 3: MTBE; 4: DCM; 5: chloroform; 6: acetone; 7: ethanol; 8: methanol; 9: ethanol-water(7:3); 10: methanol-water (8:2); 11: methanol-acetic acid (9:1); 12: methanol-ammonia 25% (8:2).

  39. Extraction of an unknown sample Example: Kumis Kuching Non polar mobile phase: toluene, ethyl acetate (95:5) for nonpolar compounds and essential oils 1 2 3 4 5 6 7 8 9 10 11 12 Extraction solvent: 1: heptane; 2: toluene; 3: MTBE; 4: DCM; 5: chloroform; 6: acetone; 7: ethanol; 8: methanol; 9: ethanol-water(7:3); 10: methanol-water (8:2); 11: methanol-acetic acid (9:1); 12: methanol-ammonia 25% (8:2).

  40. Characteristic of medicinal products • Every herbal extract is a complex mixture of various substances • Every extract shows considerable natural variations in it’s the composition • In many cases the single therapeutically active constituents of herbal drug are not known • Proof of therapeutical equivalence of such complex mix of constituents is hardly possible • Clinical trial is very difficult

  41. KLT untukIdentifikasi danPenetapan Kadar Produk Herbal

  42. Applikasi KLT KLT untukidentifikasidanpenetapankadar formula: • KombinasiEkstrakRimpangKunyitdanHerbaSamiloto • KombinasiEkstrakRimpangKunyitdanDaunjambu

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