市售盐酸二甲双胍片的质量评价  

Principles for quality evaluation of marketed metformin hydrochloride tablets

作　　者：薛晶[1] 邹文博[1] 崔学文[2] 马文利 薛立宁 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]四川省食品药品检验所,成都610036 [3]北京药学会,北京100027

出　　处：《中国新药杂志》2011年第3期274-279,共6页Chinese Journal of New Drugs

基　　金：北京药学会药品技术评估中心资助项目

摘　　要：目的:以盐酸二甲双胍片为例,从药物分析角度对国产仿制药的质量与原研厂的产品质量进行对比研究,浅析上市药品质量评价的几点原则。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,选择具有临床意义的有关物质、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的质量相当,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令人满意,但部分厂家的样品与原研厂产品在体内生物利用度、临床疗效及副作用方面是否完全一致有待进一步的探讨。Objective： To compare the quality of generic drugs manufactured by domestic pharmaceuticals with the original product and list principles for quality evaluation of marketed drugs with metformin hydrochloride tablets as an example.Methods： Based on three basic elements of drugs（safety,efficacy and quality control）,comparison and evaluation of the quality were performed on related substances,dissolution and content,which closely related to clinical efficiency.Results： In related substances and content,domestically produced generic drugs and the original product were equivalent,but there were differences on dissolution.Conclusion： Compared with the original product,the safety and quality control of domestically produced generic drugs are satisfactory.However,whether the in vivo bioavailability,clinical efficiency and side effects of some domestic samples are entirely consistent with the original product or not will be further explored.

关 键 词：仿制药 质量 评价 盐酸二甲双胍 

分 类 号：R927.11[医药卫生—药学] R977.15