常用口服雌激素避孕药制剂的含量均匀度考察

The quality investigation on the content uniformity of oral estrogen contraceptive preparations

目的 建立口服避孕制剂含量均匀度的检查法 ,考察中国常用口服雌激素避孕药制剂的内在质量。方法 以十八烷基硅烷键合硅胶为填充剂 ,以不同比例乙腈 -水为流动相 ,检测波长 2 2 0nm。结果 所测定的 3批样品 6个品种中 ,除复方炔诺孕酮薄膜衣片和左炔诺酮片含量均匀度符合规定外 ,其余含量均匀度未达到药典要求 (A +1 8s >15 )。结论 首次采用HPLC方法对我国女性常用的避孕制剂的含量均匀度进行考察 ,测定结果不尽人意。为确保避孕药使用的安全有效 ,需要尽快制定避孕制剂的含量均匀度的检查要求。

OBJECTIVE To investigate the content uniformity of the oral estrogen contraceptives commonly used in China.METHODS An HPLC method was used with C 18(4.6 mm×250 mm,5 μm)column.Different rations of acetonitrile-water were used as the mobile phase and the detective wavelength was set at 220 nm.RESULTS The results showed that the content uniformities of levonorgestrel tablets and compound norgestrel film coated tablets were good,but content uniformities of the three test batchs of compound levonorgestrel pills and compound norgestrel sugar coated tablets as well as one batch of levonorgestrel and quinestrol tablets/norgestrel and quinestrol tablets were not complied with the regivrement of Chinese pharmacopoeia 2000 edition.CONCLUSION In order to safely and effectively for the safe and effective using of estrogen contraceptives,we should control the quality of contraceptive commonly used in China.