氯雷他定制剂的溶出曲线考察

目的:考察国内氯雷他定制剂与原研药之间溶出行为的差异。方法:通过体外溶出度试验,测定33家企业生产的氯雷他定片或胶囊在4种不同pH的溶出介质中的溶出曲线,用f2相似因子法与原研药进行比较。结果:共绘制105条溶出曲线,与原研药完全相似的企业仅4家,其余样品与原研药的溶出行为不一致。结论:目前国内该品种生产工艺差异较大,溶出行为与原研药存在差异。

Comparative Study on Dissolution Profiles of Loratadine Preparations

Objective： To study the difference in dissolution profiles between the domestic loratadine preparations and the original preparation. Method： According to the methods of dissolution test in vitro, the dissolution profiles of samples from 33 domestic pharmaceutical enterprises were determined in four kinds of dissolution media with different pH values, and compared with that of the original preparation by the method of f2 similarity factor. Result ： Totally 105 dissolution profiles were obtained. The samples from four pharmaceutical enterprises showed complete similarity with the original preparation. Conclusion： Great difference exists in the production process of loratadine preparations from domestic pharmaceutical enterprises, resulting in significant difference in dissolution in vitro when compared with that of the original preparation.