探讨抗生素发展的新动态.docVIP

探讨抗生素发展的新动态 中国药典各部收载的药品和生物制品是国家为保证药品生物制品质量制订的具有约束力的技术法规。它不仅是强制性的法定标准，而且还将起到指导药品和生物制品生产，保证药品生物制品质量，促进对外贸易的重要作用，同时还作为药品上市后技术监督的法定依据，因此是一部集专业性、技术性、法规性于一体的法典。2010年7月1日开始实施中国药典2010年版，在新版药典中抗生素品种做了一些必要的增加和调整，对某些检查项目进行了相应的修订。Chinese Pharmacopoeia of each department of pharmaceutical and biological products used is the country in order to ensure the quality of pharmaceutical and biological products for binding technical regulations. It is not only the statutory standards mandatory, but will also play a guiding drugs and biological products production, ensure the quality of pharmaceutical and biological products, an important role in promoting foreign trade, but also as the legal basis of post-marketing drug technical supervision, so it is a set of professional, technical, and in one of the code. July 1, 2010 Chinese Pharmacopoeia 2010 edition of implementation, in the new edition of the Pharmacopoeia antibiotics do some necessary to increase and adjust, some inspection items for the corresponding revision.　　1.1 中国药典2010年版中抗生素收载品种的主要变化在中国药典2010年版中新增加的品种及制剂总共76个，其中喹诺酮类抗生素为16个，说明我国在喹诺酮类抗生素方面的研究比较迅速。喹诺酮类抗生素不同于其他微生物来源的抗生素，由于其源于化学全合成，因此对于在国外已上市，我国临床上需要、但又无专利约束的喹诺酮类抗生素，国内基本上都已有生产。 新版药典对中国药典2000年版［2］中收载的183个抗生素品种及制剂中的132个品种的方法或项目进行了不同程度的修订。Varieties and preparation of antibiotic 1.1 main changes of Chinese Pharmacopoeia 2010 edition collection contains varieties of increase in Chinese Pharmacopoeia 2010 edition of a total of 76, of which the quinolones antibiotics was 16, that of the quinolone antibiotics aspect in our country rapidly. Quinolones is different from other microbial antibiotics, due to its source in chemical synthesis, therefore have been listed abroad, need, our country clinical but no patent constraints of quinolone antibiotics, domestic basically have the production. Methods 132 varieties and 183 antibiotics of Chinese Pharmacopoeia 2000 edition of Pharmacopoeia ( 2 ) collection contains and preparation of or items were revised in different degree.　　1.2 国内有生产但未收载入中