不同生产厂家常用口服避孕药体外溶出度考察

目的:建立口服避孕药的溶出度测定方法,并对不同生产厂家同代产品体外溶出度进行考察及比较。方法:采用桨法进行溶出度试验,以高效液相色谱法测定A、B、C、D、E厂家口服避孕药中药物的溶出度,并提取溶出度参数。结果:除B、D厂的产品外,A、C、E厂产品的溶出度均合格;不同厂家的同代产品的溶出度参数均有显著性差异。结论:建立的溶出度测定方法简便、可靠;B厂生产的复方炔诺酮片和D厂生产的复方左炔诺孕酮片的处方与工艺还需进行改进。

Investigation of In- vitro Dissolution for Common Oral Contraceptives

OBJECTIVE:To investigate in-vitro dissolution behavior of the first, second and third generation combination oral contraceptives by their dissolution test. METHODS:The paddle method was used for the dissolution test and the two ingredients in combination oral contraceptives were determined by HPLC, respectively. And the dissolution parameters were obtained. RESULTS:The dissolution rate of all tablets was up to standard except the products of manufactory B and D. The dissolution parameters of the same generation product had significant differences. CONCLUSION:The measuring method for dissolution was simple, convenient and reliable. The in-vitro quality of products of manufactory B and D should be improved.