The Study Of Semustine Raw Materials And Preparations Quality Standards

National Essential Drug semustine(English name: Semustine, Me-CCNU) is the late 1980 s developed domestic nitrosourea alkylating anticancer drugs, is a cell-cycle non-specific drugs. Currently, its quality standards were contained in the "Chinese Pharmacopoeia" 2010 edition two. In its quality standards, safety control indicators related substances using thin layer chromatography(TLC method), you can not accurately quantify how much content related substances. Semustine content was measured by UV absorption coefficient, the method materials susceptible to interference, the measurement results accuracy is not high, and the lack of quality standards in the residual solvent control targets. In its preparation semustine capsule quality standards, the content of the same drawbacks exist, and the lack of standard indicators of effectiveness of the control drug dissolution and safety indicators related substances control inspection items. Above to serious clinical drug safety problems, in order to ensure people’s drug is safe and effective, it is necessary to re-examine and develop their quality standards.This thesis was studied for semustine raw materials and formulations quality standards, mainly studied in the following aspects:(1)In the standard of semustine raw materials, the related substances and content of the quality control methods were revised to accurate, specific and high-performance liquid chromatography.(2)In the standard of semustine capsule, updating the safety and effectiveness of the quality control checks indicator substance related items and dissolution, content uniformity check items and method for the determination revised to good precision, accuracy and specific, and inspection the results can accurately reflect the quality of drugs by high performance liquid chromatography.(3)In the standard of semustine raw materials, updating security quality control index- residual solvent checks.