SUKRASNO SITI KUSMARDIYANI

Transcription

1 SUKRASNO SITI KUSMARDIYANI

2 CONCEPT OF CRUDE DRUG ANALYSIS AND ITS PRODUCT IN RELATION TO STANDARDIZATION Concept of standardization (such as standard and quality) Factors affecting quality Scope to be measured (biological, physical, chemical and physicochemical parameters)

3 CONCEPT OF STANDARDIZATION STANDARDIZATION Process to formulate, to decide, to apply and to revise standard that is orderly conducted by involving all parties. STANDARD Technical specification that is formulated through consensus of all related parties, by considering the health requirement, safety, security, environment, science and technology development, experiences, current and future development to provide maximal benefits.

4 Formulation Data collection, data analysis, concept drafting, consensus Decision Decree by National Standard Board Application Using the standard by related parties Revision Correction for improvement

5 --Parties Involved-- Producer Government Academician STANDARDIZATION Distributor User N G O

6 CALIBRATION TECHNICAL CALIBRATION Metrology that control measurement units, measurement methods and measurement devices that include technical requirement and development method for measurement and measurement devices in line with the development of science and technology to assure the precision and correctness in measurement.

7 QUALITY Overall feature and characteristic of goods or services that demonstrate their capacity to satisfy the defined or stipulated need. Explain how it is applied to these three pharmacopoeial definitions (specially related to herbal products): IDENTITY PURITY CONTENT

8 ---- explain ---- Use this scheme to explain the concept of quality in herbal products. Wild Standardized Extract Jamu / TM Standardized Herbal Medicine Phytopharmaca Cultivated Natural Product Standardized Crude Drug Herbal Pharm l Product Cosmetic, Food, Pesticide, etc. Genetically eng. Extract Active (Pure) Compound Inert (Pure) Compound Pharm l Product / Novel Compound -Excipients-

9 Ver. 22SK005 MACROSCOPIC AND MICROSCOPIC CHARACTERISTICS PHYTOCHEMICALS WATER CONTENT EXTRACTABLE MATTER FOREIGN MATTER AFLATOXIN CONTAMINATION PESTICIDE RESIDUES HEAVY METAL CONTAMINATION RESIDUE OF FUMIGATION LOSS ON DRYING MICROORGANISMS STANDARDIZATION OF CRUDE DRUGS AND EXTRACTS Get the main reasons why this long list must be determined for crude drugs! BIOLOGICAL PHARMACY SCHOOL OF PHARMACY ITB

10 Explain how this diagram is applied in the production of standardized herbal medicines. Good agricultural practices and manufacturing processes Source and raw materials Quality of active pharmaceutical ingredients

11 Explain how this diagram is applied in the production of standardized herbal medicines. Cultivation Harvesting Primary processing Handling Storage Packaging Distribution Deterioration Contamination

12 Kebun Percobaan Manoko, Lembang, Bandung -- discuss the cultivation of medicinal plants -- Summarize and get more examples.

13 See an example of the monographs on the next slides

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15 SK Taman SF

16 SK Taman SF Taman SF

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21 .etc

22 QUALITY Factors Affecting Quality Genetics Climate Soil quality External factors Cultivation process Harvest process Post harvest process

23 GENETIC FACTORS Examples: Cinchona succirubra (red cinchona) Cinchona ledgeriana Cinchona calisaya (yellow cinchona) Capsicum frutescens all fruits are hot but they have different level of pungency Capsicum annuum certain variety is hot but some other is not hot at all.

24 Cinchona succirubra Pavon Rubiaceae SK CINCHONAE CORTEX KULIT BATANG KINA KUSMARDIYANI Kusmardiyani, Macroscopical and Microscopical Analysis of Crude Drugs, Ver. 22SK005

25 Manoko, Lembang KUSMARDIYANI Cinchona ledgeriana Cinchona succirubra Explain the differences! KUSMARDIYANI Kusmardiyani, Macroscopical and Microscopical Analysis of Crude Drugs, Ver. 22SK005

26 Find out both species of Cinchona and once again explain the morphological differences. KUSMARDIYANI Perkebunan Manoko, 24 Juli Kusmardiyani, Macroscopical and Microscopical Analysis of Crude Drugs, Ver. 22SK005

27 Wallis, 95.

28 THIN LAYER CHROMATOGRAPHY OF CINCHONA BARKS Cinchona calisaya & Cinchona succirubra Developing system: chloroform - diethylamine (9:1) Spray reagent: (a) 10% H 2 SO 4 in ethanol UV365nm (b) 10% H 2 SO 4, then iodoplatinate reagent visible light 1 = Cinchona calisaya extract 2 = Cinchona succirubra extract TC = a mixture of cinchona alkaloids T1 = quinine T2 = sinchonidine T3 = quinidine T4 = sinchonine Wagner, TLC Atlas.. (a) (b) What is the conclusion?

29 Chemical races Morphologically and taxonomically the same. Chemically different: Quantitatively Qualitatively Causing factors: Especially environmental factors

30 CLIMATE FACTORS Temperature Rainfall Hours of day light Altitude

31 Climate factors Dates: grow in the Middle East and produce fruits grow in Indonesia but do not produce fruits Poppy: grow normally in Mediterranean but also in Nordic countries with producing the same alkaloid. Cinchona: grow at m grow at lower level but less alkaloid Plantago major : grow in Indonesia and also in Japan Gingko biloba : grow well in Japan and produce seedling not survive in Indonesia

32 SOIL FACTORS Soil consist of rock and humus 1.5-5% humus fertile <0.5% poor Clay 2-20 µm Sand 20 µm -2 mm Gravel > 2 mm Indonesia is the most fertile soil. Volcano is the important factor in contributing the fertility of the soil. Soil ph Acid (high humic acid and lower lime) Alkaline (high lime) Most plants grow well at neutral ph

33 Examples: Soil factors Eurycoma longifolia (Tongkat Ali): grows well in Kalimantan/Borneo difficult to grow in Bandung. Andrographis paniculata and Sonchus arvensis : good in calcium rich soil. Digitalis: grows poorly in calcareous ground.

34 IRRIGATION Water is essential for plant to grow. During dry season plant need external supply of water. Some plants grow better with irrigated water than from rain. Some plants do not stand with over supply of water. Rice is better in soil with sufficient water than excessive water.

35 Weed Control Weed control Manual, Mechanical, Chemical Weeding out is essential to support the early stage of development. Pest Control Pest control is conducted routinely to avoid lost. Pest control: Manual, Physical, Physico-chemical, Chemical(pesticide)

36 Pest Control Pest control is conducted routinely to avoid lost. Pest control: Manual, Physical, Physico-chemical, Chemical(pesticide) Pesticide provide residue that must be tested. There is maximal limit for pesticide residue level

37 Disease Control Plant infection: Microorganism Bacteria Fungi Virus Viroid

38 HARVESTING Part of the organ & Time of harvest When to get the highest amount of active constituents: LEAVES FLOWERS FRUITS SEEDS BARKS WOODS ROOTS RHIZOMES HERBS?

39 Gathercoal

40 TIME OF COLLECTION quality of vegetable drugs ---- Read and Discuss Gathercoal

41 TIME OF COLLECTION quality of vegetable drugs Pyrethrum flowers Pyrethri flos The flowers gathered when they are closed produce the finest and most powerful insect powder, nearly 2x that made from the-half-closed or open flowers Gathercoal

42 dried flower bud Select the most suitable plant part! KUSMARDIYANI

43 How would you plot the analytical protocols of such a crude drug? VOLATILE OILS

44 Harvesting 1. Seasonal variation Ephedra maximum level in fall season. Duboisia myoporoides (October 3% hyosiamine, April 3 % scopolamine). Curcuma domestica (maximum amylum level just after termination of rainy season. How about curcuminoid level?) 2. Age of organ maximal level of capsaicin before fruit turning to red colour phenolics mostly decrease when the organ growth ceases

45 Post harvest (1) Sorting and Cleaning Sorting Separation from other part of the plants from the same species or different species. Removal of substandard quality Washing Separation from natural contamination during cultivation and harvesting.

46 Post harvest (2) Cutting Slicing and grinding ginger rhizome decrease volatile oil level. Grinding substantially reduce the volatile oil content. Slicing and grinding curcuma rhizome does not affect the volatile oil content. Slicing onion, garlic and dioscorea substantially alter the constituent of the crude drug.

47 Post harvest (3) Fermentation Fresh material is placed in thick layers and some times covered and often exposed to higher temperature and humidity. Remove bitter or unpleasant taste Promote the formation of aromatic compound with pleasant smell or taste. Vanilla, tea, cacao, patchouli oil leaves, etc.

48 Post harvest (4) Drying method Under sun light In an air oven At ambient environment (natural aeration) Dried air flow Tunnel type drier

49 Post harvest (5) Banana Ripe fresh Ripe dried ( sale ) Kesemek (kaki) Extremely different taste for: Fresh Dried

50 Storage Great problem with crude drug Pest infestation Microbial contamination Chemical stability of constituent Glycosides and esters: less stable compared to alkaloids. Essential oil: evaporation, oxidation and polymerization. Tannin: very stable Expiration date is important for crude drug (??)

51 Quality assurance of plant materials used as the source for herbal medicines To improve the quality, safety and efficacy of finished herbal products The guidelines need to be adjusted acc. each country s situation. 2003

52 Production costs Price of the final products Affordability of medicines a reference to be developed acc. circumstances

53 Summarize: CONCEPT OF CRUDE DRUG ANALYSIS AND ITS PRODUCT IN RELATION TO STANDARDIZATION Concept of standardization Factors affecting quality Scope to be measured