Standardization of drugs

Standardization of drugs - determination of the quantitative indicators of the quality of medicines, and to bring samples to established standards. In most cases, standardization of drugs is carried out by chemical and physical-chemical methods of research. In cases when it is not selected chemical composition of the drugs, or they contain biologically active substances in so small weight number that it is not detected by chemical means, they are subjected to biological valorization or biological standardization.
Biological standardization shall be the majority of cardiac glycosides, organopreparaty, many antibiotics and other medicines. Biological standardization is carried out on animals, isolated organs, cultures of microorganisms with methods that allow you to evaluate the most important in therapeutic attitude towards the action of this drug. For example, the activity of preparations cardiac glycosides is determined by their ability to cause systolic cardiac arrest frogs, cats, pigeons. About activity of insulin is judged to reduce the level of sugar in the blood of the rabbits, the pituitrin - reduction of smooth muscles of the uterus Guinea pigs. In the standardization of antibiotics determine the concentration in which they inhibit the growth of the test microbes. When using any of these methods, the activity of the test drug is mapped to standard with permanent activity, expressed in conventional units (ED). For some drugs established international standards and appropriate international or international units of action (S or ME). For greater reliability of results of biological standardization is carried out on a sufficient number of animals using methods of mathematical statistics. For products subject to mandatory biological standardization, detailed descriptions of the standards and methods of standardization are in the State Pharmacopoeia of the USSR.