Dr S Nayak PPT STANDARDIZATION OF HERBAL DRUGS & FORMULATIONS

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ADVANCE TECHNIQUES IN STANDARDIZATION OF HERBAL DRUGS & FORMULATIONS

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ADVANCE TECHNIQUES IN STANDARDIZATION OF HERBAL DRUGS & FORMULATIONS Dr. Satish Nayak Principal Bansal College of Pharmacy Bhopal

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PROBLEMS WITH MODERN DRUGS High cost (upwards of $ 2000 million) and long time (15-20 yrs) taken in development of new drugs. Toxicity- A new branch of medicine is termed iatrogenic diseases. Non-renewable source of basic raw materials. Most synthetic drugs utilizes fossil resources like petrochemicals. Environmental pollution by the chemical industry. Inadequate, specially in management of certain chronic diseases.

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ADVANTAGES OF PLANT BASED DRUGS Long history of use and better patient tolerance as well as public acceptance. Renewable source. Cultivation and processing environmental friendly. Local availability, specially in developing countries. Several important recent breakthrough. Plant constitute to be a major source of new lead generation.

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SELECTION OF HERBAL Evidence from indigenous material media. Evidence on the basis of data on experimental animals; and Chemotaxonomic or biogenetic theory evidence of presence of novel compounds.

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Planning of plant collection trips. Criteria for the selection of species. Collection and processing Identification and Documentation Recollection of biologically active plants COLLECTION AND IDENTIFICATION

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ISOLATION AND IDENTIFICATION OF MEDICINALLY ACTIVE CONSTITUENTS Fractionation of initial extract with a range of solvent of increasing polarity, i.e. petroleum ether, benzene, chloroform. Fractionation of the initial extract into acidic, neutral and basic components, or The initial extract could be crudely fractionated according to the molecular weight of its components using a molecular sieve, eg. the sephasexes

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METHODS OF PURIFICATION CHROMATOGHRAPHY Thin layer chromatoghraphy High performance thin layer chromatography Column chromatoghraphy GLC chromatoghraphy Ion exchange chromatoghraphy High performance liquid chromatography Gel permeation chromatography Affinity chromatography

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1. Ultra-violet & Visible spectrophotometry 2. Infra red spectroscopy 3. Fluorescence Analysis 4. Nuclear Magnetic Resonance spectroscopy Mass spectrometry 6. X-ray difraction 7. Radioimmuno assays SPECTROPHOTOMETRIC METHODS

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AYURVEDIC/HERBAL FORMULATION Asava and Arista Asavas & Arista are the medicinal preparations processed by soaking the drugs in the powdered form or in the form of their decoction. e.g.:- Kumariasava Madhukasava Punarnavasava 2. Arka It is the liquid preparation obtained by distillation of certain crude drugs soaked in water using the distillation unit. e.g..:- Ajmodarka Karpurady Jatamansyarka 3. Avaleha or Leha and Paka Avaleha or leha is a semisolid preparation of drugs prepared by addition of sugar, jaggery (gur) or sugar candy and boiled with prescribed drug-juice or decoction. e.g.:- Kutajavaleha Draksavaleha

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4. Kvatha (decoction) This is prepared by boiling the crude drug in water. e.g.:- 5. Churna Fine powder of drug or drugs is known as churna. e.g.:- Triphala churna Trikatu churna Drakshadi churna 6. Dravaka The liquid preparation obtained from lavans or ksharas are known as dravaka. e.g.:- Sankha-dravaka 7. Ksharas Alkaline substances obtained from the ash of drugs are known as Ksharas. e.g.:- Apamarga Ksara Palasa Ksara

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8. Lepa The preparation in the form of paste meant for external application on the body is known as Lepa. e.g.:- Sinduradi lepa Pathyadi lepa 9. Vatika & Gutika Medicaments in the form of tablet or pills are known as Vatika and Gutika. e.g.:- Gandhaka vati Lasunadi gutika 10. Netrabindu & Anjana Netrabindu is processed by dissolving the specified crude drugs in water or kasava or honey and used as eye drops. Anjana are very fine powders of medicaments to be applied with netrasalaka e.g.:- Muktadi mahanjana Chandroday vartti 11. Sattava Water extractable solid substance obtained from a drug is known as Sattava. e.g.:- Guduchi sattava

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12. Pisti It is obtained by triturating the drug with the specified liquid and exposing the same to sun or moon light. e.g.:- Praval pisti Mukta pisti Manikya pisti 13. Ghrita (Snehkalpa) Ghritas are the preparations in which ghee is boiled with the prescribed quantity of the decoction (Kasava) and fine paste (Kalka) of the drug as specified in formula. e.g.:- Asoka ghrita Nirgundi ghrita 14. Taila (Medicated oils) They are called sneha kalpa/paka and prepared by cooking oil with the juice or the decoction and paste of drugs. e.g.:- Bhringaraja taila Maha NArayan taila Laghu Visagarbha taila

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15. Bhasma The powdered form of the substance obtained by calcination of metals, minerals or animal product by a special process in a closed crucibles. e.g.:- Tamra-bhasma Godanta bhasma Pravala bhasma 16. Rasa- Yoga The medicinal preparation containing mineral drugs as their main ingredients, in the form of powder or pills. e.g.:- Karpura-rasa Icchabhedi-rasa Tribhuvana kirti-rasa 17. Kupipakva Rasayana The mineral and drugs of metallic origin in the powdered form are mixed together and placed in glass flask occupying about 1/3rd of the volume. e.g.:- Rasa karpura Rasa sindura Makaradhvaja

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18. Fant (fanta) These are prepared by pouring hot water over the dry crude drugs. 19. Nikandha The residue or marc obtained in kadha or kashaya is treated with boiling water and strained. The filtrate thus obtained is known as Nikatha. 20. Ghana-saar The decoction obtained in the preparation of Kadha or Nikandha is further evaporated to semi-solid mass is known as Ghana-saar. 21. Kalka When fresh or dry crude drug is powdered and pounded with water hot or cold to give a very fine paste then it is termed kalka.

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22. Swarasa When the kalka is pressed between the palm of the hand or is expressed through the layers of cloth to produce a thick juice, then it is called swaras. 23. Parpati kalpas The mineral herbal drugs are processed by special technique of roasting and are converted into flattened scales or thin layers. 24. Siddha-milks The drops obtained by burning medicinal substances like roots or fruits or wicks impregnated with medicinal extracts are allowed to fall in boiling milk and are thoroughly mixed by stirring. The drops getting mixed with milk are enriched with medicinal activity.

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25. Kajjali An amalgum used in ayurvedic system of medicine as a vehicle for other medicines is prepared by mixing equal quantity of mercury ans sulphur. 26. Matras Highly potent, stick like preparations are known as Matras. 27. Nassyas These are the nasal preparations and may be very fine powder, aqueous or oily preparations. 28. Praash They are semisolid preparations like jams. These are highly palatable preparations used for refreshing or rejuvination of the body.

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STANDARDIZATION OF HERBAL FORMULATIONS Raw Material Standardization In Process Standardization Standardization of Finished Product

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STANDARDIZATION METHODS 1. Morphological or organoleptic evaluation 2. Microscopic Evaluation (a) Leaf constants (b) Trichomes (c) Stomata (d) Quantitative microscopy

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Phytochemical test for alkaloid, glycosoids, terpenes, carbohydrates, fixed oil and fats, volatile oils, sterols, saponin, tenins, amino acids, gums and mucilages. 3. Chemical Evaluation

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4. Physical Evaluation (i) Moisture content (ii) Viscosity (iii) Melting point (iv) Solubility (v) Optical rotation (vi) Refractive index

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(vii) Ash values and extractives Ash value (b) Extractives (viii) Volatile oil content (ix) Foreign organic matter

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5. BIOLOGICAL STANDARDIZATION It is a process by which an unknown drug is compared and adjusted in terms of the standard. Bioassay is defined as the estimation of the nature, concentration or potency present in unit quantity of the test substance by measurement of the biological response that it produces.

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One can measure the biological activity of new or chemically undefined substances. Substances which undergo decomposition during chemical assay can be estimated biologically without loss of potency. To measure the therapeutic effectiveness of a new drug treatment. To measure the toxicity of a new drug. ADVANTAGES :-

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Biological variation Time consuming Costly Cruelty to animals DISADVANTAGES:-

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PRINCIPLES OF BIOLOGICAL STANDARDIZATION The biological activity of a unknown drug or chemical should always be compared with an internationally accepted standard. The biological activity exhibited by the test compound in the living system should closely resemble the therapeutic activity of the drug, e.g.: (a) The bioassay of a cardiac glycoside should be done by measuring its activity on cardiac muscle, since cardiac glycoside is used in the congestive heart failure. (b) The bioassay of a new insulin preparation can be done by measuring the hypoglycemic effect of new preparation in rabbits. 3. Species which show maximum sensitivity should be selected for the bioassay. Eg. Guinea pig ileum is most sensitive to histamine. 4. The bioassay method should give reproducible results. 5. Bioassay should be designed properly in order to estimate error limits by statistical analysis.

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Methods Employed in Biological Standardization Two major types of methods are done in the laboratory Graded response bioassay Quantal response bioassay

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Graded response bioassay (Quantitative dose effect relationship bioassay):- In graded response bioassay the dose of the drug is related to the size of the response produced in single biological limit. This graded reponse bioassay may be performed by the following methods: (a) Matching Methods (comparative method, bracketing method, direct assay) (b) Indirect methods: (i) graphical or interpolation method (ii) three point bioassay (iii) four point bioassay

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Direct bioassay (matching method), (comparative, bracketing method):- The aim of the matching method of bioassay is to determine the doses of the standard and unknown that produce the same response. e.g. bioassay of acetylcholine by matching method using frog rectus abdominus muscle.

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BIOLOGICAL EVALUATION Hepatoprotective activity Hypoglycemic activity Anti-fertility testing Anti-inflammatory activity Neuropharmacological activity Testing for anti-ulcer activity Anti-insect activity Immunomodulatory activity Anti-asthematic activity Wound Healing activity

Other Parameters:

Other Parameters 1. Appearance 2. Colour 3. Odour 4. Taste 5. Paritcal size 6. Flowability

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7. Viscosity 8. Clarity 9. pH 10. Moisture content 11. Sedimentation profile 12. Flocculation 13. Friability

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14. Hardness 15. Extractive values 16. Volatile matter content 17. Free fatty acid/acidity 18. Peroxide value 19. Microbiological parameters-total viable count, yeast/mold count

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WHO Guidelines For the purpose of quality control of herbal drugs, W.H.O. has prepared accordingly guidelines. The objectives put forth are provisions for recommended general test methods and also the general limits for contaminants for herbal drugs. A typical monograph for herbal drugs as per WHO guidelines is as follows:- MONOGRAPH TITLE Botanical Physicochemical Pharmacological Toxicological

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BOTANICAL Sensory Evaluation:- Visual Macroscopy/ Touch/ Odour/ Taste Foreign Matter:- Foreign plants, foreign animals, foreign minerals etc. Microscopy:- Histological observation, Histochemical detection, measurements etc.

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PHYSICOCHEMICAL TLC:- Total, Acid insoluble, Water soluble Ash:- In hot water, cold water and ethanol Extractable Matter:- LOD, Azeotropic Volatile Oils:- By steam distillation

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PHARMACOLOGICAL Bitterness Value:- Units equivalent to bitterness of standard solution of quinine hydrochloride Haemolytic Activity:- On ox blood by comparison with standard reference saponin Astringency:- Fraction (tannins) that bind to standard hide powder Swelling Index:- In water Foaming Index:- Foam height produced by 1 gm material under specified conditions

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TOXICOLOGICAL Pesticide Residues:- Total organic chloride and total organic phosphorus Arsenic:- Stain produced on HgBr 2 paper in comparison to standard stain Heavy metals:- Cadmium and Lead

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Microbial Contamination Total viable aerobic count Pathogens: Enterobacteriaceae, E. coli Salmonella, P. aerogenosa, S. aureus Aflatoxins: by TLC using standard aflotoxin (B 1 , B 2 , G 1 , G 2 ) mixture Radioactive Contamination

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Monograph title Definition Introductory Passage Constituents Therapeutics Regulatory Status References Relevant excerpts from regulator guidelines of certain EC countries Therapeutic Section Monograph for herbal drugs in British Herbal Pharmacopoeia

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W.H.O. Guidelines for general limits ( Contaminants in herbal drugs ) Harmful organic matter:- Totally free from it 2. Innoccuous foreign matter:- Free from it (to maximum possible extent) 3. Pesticidal residues, arsenic and heavy metals:- BW× ADI ×Extraction factor Maximum residue limits = Safety factor 100 × MDI where, ADI = Average daily intake BW = Body weight MDI = Mean daily intake of drug

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4. Microbial load (Contamination):- 5. Afflatoxins:- Totally free from it 6. Radioactive contaminants :- As per recommendations of International atomic energy agency (IAEA), Vienna, Austria. (wherever applicable only) Microbes Crude drug for Processing Ready for Internal use Ready for Topical use (i) Salmonellae - nil nil (ii) Enterobacteriaceae - 10 3 10 4 (iii) Total aerobic - 10 5 10 7 (iv) E. coli 10 4 10 10 2

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