不同厂家克拉霉素制剂含量、有关物质及溶出度的对比研究  

Comparison of Content,Related Compound A and Dissolution of Clarithromycin Tablets from Different Manufacturers

作　　者：王彪[1] 张翠莲[1] 梅丹[1] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院,北京100730

出　　处：《中国药学杂志》2014年第21期1933-1938,共6页Chinese Pharmaceutical Journal

摘　　要：目的对克拉霉素国产仿制药与原研厂的产品进行质量对比研究,评价部分国产仿制药与原研产品之间的质量差异。方法从药品的安全性、有效性和质量可控性3个基本要素出发,选择有关物质、溶出度和含量等指标进行比较和评价。结果国产仿制药与原研厂产品在有关物质和含量方面均符合《中国药典》2010年版的有关要求,但溶出度存在差异。结论与原研厂产品相比,国产仿制药的安全性和质量可控性尚有提升空间,国产仿制药与原研厂产品在体内生物利用度、生物等效性、临床疗效等方面是否完全一致有待进一步探讨。OBJECTIVE To evaluate the quality differences of generic clarithromycin tablets manufactured by domestic pharmaceuticals with the original product.METHODS Based on three basic elements of drugs（ safety,efficacy and quality controllability）,comparison and evaluation of the quality were performed on related substances,dissolution and content.RESULTS In related substances and content,domestically produced generic drugs and the original product were all conform to standard of Ch.P 2010,but there were differences in dissolution.CONCLUSION Compared with the original product,there has space for domestically produced generic drugs to improve the safety and quality controllability.Further research is necessary to confirm whether the bioavailability,bioequivalence and efficacy of generic products are completely consistent with the original product.

关 键 词：仿制药 质量 评价 克拉霉素 

分 类 号：R917[医药卫生—药物分析学]