氯氮平片的溶出曲线考察

Comparative Studies on Dissolution Curves of Clozapine Tablets

目的:考察氯氮平片在4种不同pH溶出介质中的溶出行为与参比制剂之间的差异,比较不同厂家药品的内在品质为药品质量控制提供参考。方法:通过体外溶出度试验,测定18家企业生产的46批氯氮平片在4种不同pH的溶出介质中的溶出曲线,用相似因子(f_2)法与参比制剂进行比较。结果:共绘制46条溶出曲线,与参比制剂完全相似的批次仅占4%(一个企业的2个批次),其余样品与参比制剂的溶出行为不一致。结论:目前国内该品种生产工艺差异较大,溶出行为与参比制剂存在差异。生产企业应加强处方工艺的筛选、优化提高改进生产工艺。

ABSTRACT Objective： To study the difference in dissolution behavior of elozapine tablets in four different media between the do- mestic preparations and original preparation to compare the internal quality of the tablets from various manufacturers and provide refer- enee for the drug control. Methods： Referring to the methods of in vitro dissolution test, the dissolution profiles of 46 batches of sam- pies from 18 pharmaceutical enterprises were determined in four kinds of dissolution media with different pH values, and the results were compared with that of the original drug by the method off2 similarity factor. Results： Totally 46 dissolution profiles were drawn out. The profiles of two hatches of samples from one pharmaceutical enterprise were similar to that of the original drug, which account- ing for 4%, and that of the other samples showed notable difference from that of the original drug. Conclusion： The preparation tech- nology of the tablets from domestic has great difference, which leads to significant difference in dissolution behavior. The screening and optimization of the production process in domestic pharmaceutical enterprises should be strengthened to improve the preparation technology of elozapine tablets.