洛伐他汀发酵产物中杂质成分的分离与鉴定-微生物与生化药学专业毕业论文.docxVIP

两南大学硕十学位论文 两南大学硕十学位论文 Abstract The purification and identification of impurities in lovastatin Postgraduate Zhu Hucheng Tutor：Associate Professor Deng Jun ·ABSTRACT This article reviewed the pharmacological effects and clinical applications of statins(a kind of medicines inhibiting hydroxymethyl coenzyme A reductase)，鹊well嬲 the update progress in th．e studies on pharmacology and production of lovastatin·one important member of stafins，and made a conclusion that the prospect of lovastatin will still be good or even better． The development of technology put a higher standard on the pharmaceutical products．USP requires that the total impurities in lovastatin should be less than 1．O％ and a single impurity should be less than 0．2％，unless sufficient data are provided to prove that the impurity has the same pharmacological activities鹊the principal component，and that the impurity has no other toxicological effects．China is the major supplier of raw materials of lovastatin to the whole world．In order to meet the new national pharmacopoeia requirements of lovastatin,it is necessary to carry out basic study on impurities in lovastatin．First．compounds should be obtained to identify tlleir structures and study their properties．Then those should make clear in which steps these impurities are generated，．how to reduce the production of the impurities，and how to remove them．Meanwhile，enough amount of monomer impurities should be accumulated to conduct various pharmacological and toxicological studies． This paper is aimed at purifying the impurities of lovastatin and identifying meir structures．In this study,the crystal liquor of lovastatin from the final step of extraction and purification was separated by repeatedly silica gel column chromatography,silica gel preparative TLC，RP-silica gel column chromatography,semi—preparative HPLC and other methods and 6 pure cbmpounds were obtained．The structures of the 6 compounds were elucidated on the basis of analying the spectral data of