2013年国家评价性抽验克拉霉素制剂质量分析与研究-《中国药事》编辑部.docVIP

克拉霉素制剂质量评价与分析 肖甜甜，毛新, 隋思博（吉林省药品检验所，长春　130033） 摘要目的: 对克拉霉素制剂的内在质量进行评价，为生产、质控、监管提供参考。方法:对277 批样品按照现行标准进行检验，并对检验结果进行统计分析考察克拉霉素片在4种溶出介质中的溶出行为。结果: 法定检验277批样品全部；；国产克拉霉素片的溶出与参比制剂的溶出曲线。结论:克拉霉素制剂克拉霉素制剂质量进一步 关键词：　克拉霉素制剂；国家评价性抽验；质量分析； 中图分类号：　　文献标识码： Quality Evaluation and Analysis of Clarithromycin Preparations Xiao Tiantian，Mao Xin，Sui Sibo (Jilin Institute for Drug Control，Changchun 130033，China) Abstract Objective: To evaluate and analyze the quality of Clarithromycin preparations, so as to provide reference for manufacturing, quality control and inspection.Methods: A total of 277 samples were tested according to the current official standards and data was 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 official standards were in accordance with the provisions. Self-developed method was superior to the official 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 most deviated from the reference sample by various extents. Conclusion: Although all samples fulfill the demands by official standards, our pioneer study suggests that there’s much more can be done to improve the quality of clarithromycin. Keywords: drug monitoring;clarithromycin preparations; national assessment programs; quality analysis; determination of related substances;impurity profile;the dissolution curveｐｒｅｐａｒａｔｉｏｎｓ ｗａｓ ｅｖａｌｕａｔｅｄ ｂｙ ｓｔａｔｉｓｔｉｃａｌ ａｎａｌｙｓｉｓ ｏｆ ｔｈｅ ｒｅｓｕｌｔｓ．Ｔｈｅ ｄｉｓｓｏｌｕｔｉｏｎ ｏｆ Ｂｉｆｅｎｄａｔｅ ｐｒｅｐａｒａｔｉｏｎｓ ＫＥＹ ＷＯＲＤＳ： Ｂｉｆｅｎｄａｔｅ ｐｒｅｐａｒａｔｉｏｎｓ；ｎａｔｉｏｎａｌ ａｓｓｅｓｓｍｅｎｔ ｐｒｏｇｒａｍｓ；ｑｕａｌｉｔｙ ａｎａｌｙｓｉｓ [1]。不良反应较少克拉霉素制剂2013年国家药品评价性抽验品种，我所对来源于31个省（区、市）的克拉霉素制剂( 112 批片剂、100批胶囊、57批分散片和8批颗粒) 按照现行质量标准进行了全项检验。对检验数据进行统计分析，对有关物质、溶出度等重点项目进行探索性研究，对克拉霉素制剂的内在质量进行研究评价，并为生产、质控、监管提供参考。 此次抽取四种剂型共277批样品，其中，片剂1