On the Chinese characteristics of the analysis of drug quality standards and common problems_0.docVIP

 PAGE \* MERGEFORMAT 18 On the Chinese characteristics of the analysis of drug quality standards and common problems [Keywords:] Chinese drugs, quality standard, determination Drug quality standards of Chinese medicine research is an important part of drug discovery. Chinese drug is not marketed in China, Chinese medicine, consists mainly of new active ingredients, active fractions and compound and so on. Among them, the active ingredients of medicinal substances essential drugs clear, and chemical drugs similar difference is: the active ingredient in traditional Chinese medicine most of the main components of impurities analogues, physical and chemical properties and biological activity of most of the similar, so the lower limit of control requirements, the effective part of a new drug API generally contain at least 50% of the active ingredients of the same structure type, and the rest of the ingredients are mostly unknown, but by a number of traditional Chinese medicine is made from raw materials extraction process, in which most of the active ingredient is not clear, and contained components many kinds of content is low, the relevant components in the analysis, the separation is difficult, a large disturbance. These new drugs to the quality standards of Chinese medicine and chemical drugs with different characteristics. 1 Chinese study the characteristics of drug quality standards 1.1 Exploratory 1.1.1 basic research related For less clear what kind of specific components of Chinese medicine in which the structure or the type of composition, what is the drug of the active ingredient composition is possible, what analytical techniques and methods for composition analysis of Chinese medicine, the work is basic research in new drug research the scope of the work is exploratory. With the full support of basic research related to establishing stronger quality control standards. Recalling the development of quality standards for Chinese history,