曲匹布通片的溶出特性

摘要

目的：通过对曲匹布通片在多种介质中进行溶出实验，对比分析国产制剂与参比制剂的溶出特性，为仿制药的一致性评价提供依据。方法参考«日本橙皮书»推荐的4种溶出介质和国内现行标准中收载的介质测定溶出曲线，用f2因子计算判断其相似性。结果国产制剂与参比制剂在水、pH值4.0、pH值1.2缓冲液中时f2均在50以下，溶出曲线不一致；不同厂家国产制剂之间的溶出行为不相似；同厂不同批号间的国产制剂在水中的f2均>99.9，溶出行为相似。结论国内现行标准中的溶出度检查法不能区分不同企业产品的溶出差异，应修订完善。国产制剂与参比制剂、国产制剂之间的质量存在较大差异。%Objective To compare the dissolution behavior between domestic trepibutone tablets and original reference product, and provide a basis for evaluating the quality consistency of generic drugs. Methods Four dissolution media recommended by Japanese Orange Book and a domestic standard dissolution media were selected to determined the dissolution profile,and f2 factor was calculated to investigate the consistency of stripping curves. Results In water,pH 4.0 and pH 1.2,the f2 of domestic formulation and reference formulation was under 50,and the dissolution profile was inconsistent.Dissolution behavior of domestic preparations of different manufacturers was dissimilar.In water,the f2 of domestic preparations of different batches of the same manufacturer was over 99.9,and the dissolution behavior was similar. Conclusion The dissolution method of existing domestic standard can not distinguish the dissolution behavior of different products,and it should be revised and completed.There is still great difference in quality between the domestic preparations and reference preparations.