Kotov A. Pharmacopoeial aspects of standardization of herbal drugs and herbal drug preparations

A complex of systematic scientific studies of local herbal drugs is given. The scientific concept was developed for elaborating of the requirements to herbal drugs that are harmonized with European Pharmacopoeia and reflect national specifics of Ukraine and their introduction into the State Pharmacopoeia of Ukraine. Using this concept 90 monographs on herbal drugs and tinctures were introduced into the State Pharmacopoeia of Ukraine. For the first time in Ukraine a complex experimental study of compliance of quality parameters for 21 chosen objects - herbal drugs that were standardized for the content of carbohydrates, phenolic acids, coumarins, flavonoids, essential oils, triterpenoids and alkaloids with the principal normative documents has been conducted. On the basis of these studies national methods of identification and assay, national monographs and national requirements concerning regulation of quality parameters of herbal drugs were introduced into the State Pharmacopoeia of Ukraine. The proposed algorithm was used to draw up monographs for 7 species of herbal drugs for the Pharmacopoeia of the Republic of Kazakhstan. Common approaches to standardization of purple coneflower tincture, motherwort tincture and calendula tincture were developed and relevant national monographs were introduced into the State Pharmacopoeia of Ukraine. Methods of quality control for drugs with adaptogenic and sedative - hypotensive effects were developed using approaches concerning development of monographs for tinctures.