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quality control of herbal drugs
- 1. QUALITY CONTROL OFHERBAL DRUGS By Firdous 1
- 2. CONTENTS: Introduction Definitions Quality parameters Procedures Conclusion 2
- 3. The term “herbaldrugs” denotes plants or plant parts that have been converted into phytopharmaceuticals by means of simple processes involving harvesting, drying, and storage. Quality can be defined as the status of a drug that is determined by identity, purity, content, and other chemical, physical, or biological properties, or by the manufacturing processes. HERBAL DRUGS : QUALITY : 3
- 4. QUALITY CONTROL OFHERBAL DRUGS : Quality control is the term that involves in processes involve in maintaining the quality and validity of manufactured product. 4
- 5. In general ,qualitycontrol is based on three important pharmacopoeial definition : 1 Identity 2 Purity 3 Assay /content 5
- 6. It can beachieved by macro and microscopic examination Out breaks of diseases among plants may result in changes to the physical appearance of the plant and lead to incorrect identification. At times an incorrect botanical quality with respect to the labeling can be a problem. Identity : Anti cholinergic poisoning 6
- 7. Purity : Itis closely linked with the safe use of drugs and deals with factors such ash values, contaminants (e.g. foreign matter in the form of other herbs), and heavy metals. Due to the application of improved analytical methods, modern purity evaluation also includes microbial contamination, aflatoxins, radioactivity and pesticide residues. Analytical methods such as photometric analysis, thin layer chromatography (TLC), high performance liquid chromatography (HPLC), and gas chromatography (GC) can be employed in order to establish the constant composition of herbal preparations. 7
- 8. It is themost difficult area of quality control to perform, since in most herbal drugs the active constituents are not known. Sometimes markers can be used. In all other cases, where no active constituent or marker can be defined for the herbal drug, the percentage extractable matter with a solvent may be used as a form of assay. Content or assay : 8
- 9. Parameters for qualitycontrol of herbal drugs : a) Macroscopic examination b) Microscopic examination c) Determination of ash value d) Determination of foreign matter e) determination of heavy metals f) Determination of pesticide residue g) Determination of microbial contaminants and aflotoxins 9
- 10. C ) determinationof ash value • Procedure • Drug is incenenerated in silica crucible at 450°c. • Total ash value • Acid insoluble ash • Water soluble ash • Sulphated ash 10
- 11. a) Macroscopic examination: 11 Cinnamonsaffron Acacia gum Nux vomica
- 12. b) Microscopic examination: Itincludes study of stomatal number , index, vein islet number, types of trichomes, starch grains , calcium oxalate crystals 12 Starch grains Stomata of digitalis Trichomes of Nux vomica
- 13. C) Determination offoreign organic matter: Lycopodium spore method : Sample + spores - suspension observed under microscope %FOM = 9400×n×W/ (S×m×p)×100 13
- 14. Where 9400= no. Ofspore's per mg n= no. Of FO particles W= weight of lycopodium spores m= weight of sample P= pure foreign organic matter present in sample 14
- 15. d) Determination ofheavy metals : •Contamination by heavy metals like cadmium, arsenic, lead, copper, and mercury . •These metals can be determined by colourreactions with special reagents. •Then these are compared with standards •Instrumental analysis have to be employed when the metals are in trace amounts. 15
- 16. Procedure: Take 5g ofdrug powder(dried at 150°c) ↓ Incinerate the drug ↓ To the ash add con.H2SO4 ↓ Incinerate at 600°c for 2-3 hour Ash obtained ↓ Dissolve the ash in 100ml of 5℅ HCL Subjected to Atomic absorption spectroscopy. 16
- 17. e) Determination ofpesticide residues •20-50g of drug + organic solvent •Subjected to TLC •Green or blue fluorescence under UV 17
- 18. •Microbial contamination: •Test forE.coli •Test for solmonella •Test for pseudomonas •Test for staphylococcus Aureus 18
- 19. Aflotoxins: •Extract of drugwith methylene chloride is evaporated •Residue is taken in column •MP is chloroform : Acetone •Elite of column is subjected to evaporation and TLC is performed. •Mobile phase. Chloroform : acetone : isopropanol •Detector : UV 19
- 20. Conclusion: •The quantitative determinationof constituents has been made easy by recent developments in analytical instruments •The results from this sophisticated techniques provide the nature of chemicals or impurities present in herbal drugs 20
- 21. References: 1) practical handbook ofpharmacognacy by khandalwal 2) Herbal technology book by Agarwal 3) Text book of pharmacognacy by Trease and Evans 21
- 22.