Quality control lec3

Quality control lec3

1. Manufacturing and Quality of Natural Medicinal Products Course code 557 Dr. Mohamed Said Lecturer of Pharmacognosy, Faculty of Pharmacy Helwan University, Egypt

2. FOAMING INDEX : The foaming ability of an aqueous decoction of plant materials and their extracts is measured in terms of a foaming index. Calculate the foaming index using the following formula: where a = the volume in ml of the decoction used for preparing the dilution in the tube where foaming to a height of 1 cm is observed.

3. Procedure: 1 g of the herbal material transfer to a 500-ml conical flask containing 100 ml of boiling water. Maintain at moderate boiling for 30 minutes. Cool and filter into a 100-ml volumetric flask and add sufficient water through the filter to dilute to volume. Pour the decoction into 10 stoppered test-tubes in successive portions of 1 ml, 2 ml, 3 ml, etc. up to 10 ml, and adjust the volume of the liquid in each tube with water to 10 ml. Stopper the tubes and shake them in a lengthwise motion for 15 seconds, two shakes per second. Allow to stand for 15 minutes and measure the height of the foam.

4. The results are assessed as follows: If the height of the foam in every tube is less than 1 cm, the foaming index is less than 100. If a height of foam of 1 cm is measured in any tube, the volume of the herbal material decoction in this tube (a) is used to determine the index. If the height of the foam is more than 1 cm in every tube, the foaming index is over 1000.

5. Determination of volatile oil Volatile oil are characterized by their odour , oil like appearance and ability to volatilize at room temperature. Chemically , they are usually composed of mixtures , such as terpenes , sesquiterpenes , & their oxygenated derivatives . Plant material is distilled with water & the distillate is collected in a graduated tube to determine oil. the aqueous portion separates automatically & is returned to the distillation flask

6. receiving tube condenser Sample + water

7. GAS CHROMATOGRAPHY

8. Limonene Mass Spectrum

9. Determination of tannin content Recommended procedure To prepare the herbal material extract, introduce the quantity specified in the test procedure for the herbal material concerned, previously powdered to a known into a conical flask. Add 150 ml of water and heat over a boiling water-bath for 30 minutes. Cool, transfer the mixture to a 250-ml volumetric flask and dilute to volume with water. Allow the solid material to settle and filter the liquid through a filter-paper, diameter 12 cm, discarding the first 50 ml of the filtrate.

10. To determine the total amount of material that is extractable into water, evaporate 50.0 ml of the plant material extract to dryness, dry the residue in an oven at 105 °C for 4 hours and weigh ( T 1 ). To determine the amount of herbal material not bound to hide powder that is extractable into water, take 80.0 ml of the herbal material extract, add 6.0 g of hide powder R and shake well for 60 minutes. Filter and evaporate 50.0 ml of the clear filtrate to dryness. Dry the residue in an oven at 105 °C and weigh ( T 2 ). To determine the solubility of hide powder, take 6.0 g of hide powder R, add 80.0 ml of water and shake well for 60 minutes. Filter and evaporate 50.0 ml of the clear filtrate to dryness. Dry the residue in an oven at 105 °C and weigh ( T ).

11. [ T 1 –( T 2 – T )] × 100 ـــــــــــــــــــــــــــــــــــ w Calculate the quantity of tannins as a percentage using the following formula: where w = the weight of the herbal material in grams.

12. Determination of Potential contaminants 1. Determination of foreign organic matter: A standard limit commonly prescribed for this kind of impurity is about 2%. If no limit is given for foreign organic matter, this means that the drugs should consist of 100 % of the substances specified in the definition.

13. Insects in drugs are a kind of foreign organic matter, but it is difficult to regulate their presence by including them under the general requirement limiting foreign organic matter. In quality control procedures the pharmacopoeias stated : Drugs containing appreciable quantities of potent foreign organic matter, animal excreta, insects or mold should however be rejected even though the percentage of such substances be insufficient to cause the rejection of the drug.

14. .2 Determination of Microbial Contaminants and Aflatoxins : Microbial contamination of medicines can lead to clinical infection. It also limit the shelf-life of the product. The vegetal materials entail the same types of microbial health risks for the user as other pharmaceuticals, namely; Infection by pathogenic micro-organisms, such as Salmonella . Microbial transformation of botanical constituents into more toxic compounds. Production of microbial toxins such as bacterial endotoxins and Mycotoxins. 15

15. Pharmacopoeial Requirements:

16. Microbial Toxins: I- Bacterial Endotoxins : Definition: Are the outer cell-wall fragments , chemically characterized as liposaccharides. Bacterial Endotoxins pyrogenic activity with pyrogenic symptoms, such as a rise in temperature, headache, joint.

17. Mycotoxins: Heavy contamination of herbal materials with yeast and molds resulted in the growth of mycotoxin producing fungi under inappropriate drying procedure and storage. A large variety of mycotoxins have been identified. Among the important toxins occurring in food and feeds are aflatoxins, patulin, ergot alkaloids.

18. Aflatoxins: Definition: Aflatoxins are poisonous metabolic by products of the growth of several species of the fungus Aspergillus; A. flavus and A. parasiticus Humans and animals can be exposed to aflatoxins in multiple ways, while the principle point of entry will be by direct consumption of aflatoxin contaminated food or feed.

19. Established and potential method to reduce the microbial contents of herbs. There are 3 methods : Gaseous treatment with ethylene oxide. Heating. Gamma irradiation.

20. Pesticides: Biological classification: Pesticides are classified according to their biological effects to: Insecticides: Applicable to various insects, and certain types of anthropods Herbicides : Applicable to weeds and undesirable plants. Fungicides : Applicable to all types of fungi. Rodenticides : Against rats, mice, and other rodents.

21. Chemical classification Pesticides can be chemically classified into: Chlorinated hydrocarbons, e.g. hexachlorocyclohexane (HCH) (Lindane), Organophosphorus pesticides: malathion, , parathion, methyl parathion. Carbamate insecticides: as fungicides. Inorganic pesticides : aluminum phosphide, calcium arsenate and lead arsenate. Plant-derived pesticides: tobacco leaf ( nicotine), pyrethrum flower extract (pyrethrin I and pyrethrin II) .

22. Maximum limit of pesticide residues for medicinal plant materials It is proposed that monographs for specific pesticides should be included in “WHO pesticides guideline for plant materials and pharmaceutical preparations”. Total DDT ) dichloro-diphenyl-trichloroethane ( - Lindane . HCH isomers not more than 0.5 ppm 23

23. Analysis of herbicide residues Most herbicide residues can be determined by HPLC. Both organic choro compounds and organophosphorus pesticides can be analyzed by GLC 24

24. Quantitative microscopy Quantitative microscopical parameters such as Fiber length, Size of trichome, Starch grain dimension, Stomatal number, stomatal index, Vein-islet number and vein These data will help in identifying the plant in powder form from its related species

25. LYCOPODIUM SPORE METHOD

26. It is an important technique for powdered drug ,especially when chemical &other method fail as accurate measure of quality Lycopodium is composed of spores of club moss plant or various fern relatives, each spore is tetrahedral in shape The spore are exceptional uniform in size(25µm) and the shape tetrahedral so that one can always know that a definite no. of spore present in particular weight of lycopodium. on an average 94000 spores per mg of powdered lycopodium

27. A powdered drug is evaluated by this technique ,if its contains well defined particles may be count ed e.g. starch grain or pollen grain.

28. Procedure: Mix about 100 mg powdered sample drug and 50 mg of lycopodium powder using a small flexible spatula on a glass plate ,with a little suspending fluid. In this mixture incorporate a sufficient quantity of suspending fluid (glycerin: mucilage of tragacanth:water::2:1:2 or an oil) until a smooth line paste results Oscillate the stoppered container gently in order to obtain uniformity of the suspension. Place one drop of suspension on each of two side ,spread with a thin glass rod or needle ,apply the cover slip and leave aside for few minutes on the table in order to allow the fluid mixture to settle eventually. Count the starch characteristic structure of sample and lycopodium spores under microscope in each of 25 different field selected for observation.

29. Calculate the %purity  of powdered drug by using the following equation: % purity of crude drug= N x W x 94000 ـــــــــــــــــــــــــــــــــــــــــــ x 100 S x M x P N=number of characteristic structure of sample in 25 field W=weight in mg of lycopodium 94000=number of lycopodium spore per mg S= number of lycopodium spore in same 25 field M=weight in mg of sample ,calculated on the basis of sample dried at 105ºc P=number of characteristic structure of sample in 1 mg (p is 2,86000 in case of ginger starch grain powder)