Standardization of AYUSH Drugs under GMP act.

Standardization means guaranteeing the minimum content of certain active ingredients in the extract.



Standardization means guaranteeing the minimum content of certain active ingredients in the extract. Clinical studies will only provide reproducible results if the active ingredient combination and the effect of each individual dose remain constant. Standardization is necessary in order to ensure the quality and safety of herbal medicine. The pharmacy or manufacturing unit must have-

Phytochemical section

The laboratory should be equipped with all the basic equipment for phytochemical analysis, chemical analysis and essay for of chemical compounds by volumetric, gravimetric, spectrometric and HPLC methods of specific marker compounds. Thin layer chromatography facilities for fingerprinting of the herbal medicine or the marker compounds for confirming the identity and authenticity of the medicine.

Microbiological section

A full-fledged microbiology section for testing bacterial and fungal contamination of herbal material with sterile testing facilities (laminar flow hood). Antimicrobial tests and a time saving and economical bioassay method using Brine shrimps for evaluating biological activity of the herbal medicines should be carried out for a preliminary screening of drugs.

In the quality control one of the very important method is TLC (Thin Layer Chromatography)-

Thin layer chromatography is particularly valuable for the qualitative determination of small amounts of impurities as well as for standardization of drug.

Two thin layer chromatography methods are described below. The classical method and the Micro method, which uses different sizes of plates and hence different quantities of solvents.

Recommended procedures

The method outlined below consumes that chromatographic plates prepared in the laboratory are used but pre coated plates, activated if necessary, maybe used provided that they have proved suitable for the application concerned.

A powdered specimen of pharmacopoeial quality may be used as the reference material. If a test for the presence of a chemical reference substance of a medicinal plant material is to be carried out, a chemical reference substance identical to that principle should be used. The test and reference solutions should be prepared simultaneously in exactly the same way. The reference solution should be of known concentration. The solvent system should be specified in the test procedure for the individual material being examined.

Preparation of samples

Prior to testing, prepare an exact of the plant material to be examined, using a rapid extraction process as follows. Add 1 to 10 ml of solvent and extract into 0.1 to 1.0 gram of the powdered plant material either by a stirring, shaking the mixture for 3-30 minutes or heating to boiling and allowing cooling. Remove the insoluble matter by centrifugation, of filter through a small funnel with filter- paper or a cotton plug. If necessary, evaporate the filtrate on the water-bath for just a long as a it required to remove the solvent, and then redissolve the residue in a small volume of solvent. If necessary, purify the test solution by preparing the extraction with solvent at different pH, or by sublimation, distillation, or other appropriate method.

ISO Standardisation

To make STANDARDIZATION of perfection and for benefits of all consumers ISO (International Organisation for Standardization) certification has been started that gives a satisfaction and confidence regarding the quality and services.

Although ISO’s principal activity is the development of technical standards, ISO standards also have important economic and social repercussions standards make a positive difference not just to engineers and manufacturers for whom they solve the basic problems in production and distribution, but to society as a whole. ISO standards also serve to safeguard consumers and users in general products and services as well as to make their life simpler.

ISO is a network of the national standards institutes of 148 countries on the basis of one member of each country, with the central secretariat in Geneva, Switzerland that coordinates the system.