克拉霉素制剂质量评价与分析  

Quality Evaluation and Analysis of Clarithromycin Preparations

作　　者：肖甜甜[1] 毛新[1] 隋思博 

机构地区：[1]吉林省药品检验所,长春130033

出　　处：《中国药事》2015年第9期932-939,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:对克拉霉素制剂的内在质量进行评价分析,为其生产、质控、监管提供参考。方法:对277批样品按照现行法定标准进行检验,并对检验结果进行统计分析;采用自行建立的方法对117批样品进行有关物质研究;考察了克拉霉素片在4种溶出介质中的溶出行为。结果:按法定标准检验,277批样品结果全部符合规定;自行建立的有关物质检查方法优于药典标准方法,共检出13种有关物质,杂质E、F是主要杂质,均来自原料;国产克拉霉素片的溶出行为各异,多数厂家产品与参比制剂的溶出曲线存在一定的差异。结论:虽然克拉霉素制剂按法定标准检验结果全部符合规定,但探索性研究结果表明,克拉霉素制剂质量还有进一步提高的空间,质量还有待于进一步优化提高。Objective： To evaluate and analyze the quality of Clarithromycin preparations, so as to provide references for manufacturing, quality control and inspection. Methods： A total of 277 samples were tested according to the current offi cial standards and data were collected for statistical analysis. Totally 117 samples were evaluated with self-developed methodology. The dissolution of Clarithromycin tablets in four kinds of solutions was inspected. Results： All the 277 samples tested by offi cial standards were in accordance with the provisions. Self-developed method was superior to the offi cial standards, which was able to detect 13 substances including the major impurities E and F from raw material. Clarithromycin tablets from domestic manufacturers had various dissolutional behaviors that mostly deviated from the reference sample to various extents. Conclusion： Although all samples fulfi ll the demands by offi cial standards, our pioneer study suggests that there is much more we can do to improve the quality of clarithromycin.

关 键 词：药品监测 克拉霉素制剂 国家评价性抽验 质量分析 有关物质检查 杂质谱 溶出曲线 

分 类 号：R927.11[医药卫生—药学]