摘要
8名健康育龄妇女按随机交叉设计先后单次口服200mg国产米非司酮及法国产RU486片剂。用HPLC测定血药浓度。两种制剂的血药达峰时间和峰值浓度十分相似,分别为0.8±0.2及1.0±0.6小时,2.34±0.75和2.25±0.63mg/L。根据药时曲线下面积估算,国产200mg片剂的相对生物利用度为法国片剂的90%,差异不显著。但法国片剂显示有稍长的平均滞留时间(MRT)。
Two preparations of 200mg mifepristone, manufactured in China and France, were randomly given to 8 healthy female volunteers in a cross- over design trial. Serum levels of mifepristone were measured by HPLC. T_(max) and C_(max) of two preparations were similar with the values of 0.8±0.2 and 1.0±0.6hr.,2.34±0. 75 and 2.25±0.63 mg/1. The relative bioavailability of Chinese product.estimated by AUC_(0-72),was 90%,showed no significant difference from French product. However, French mifepristone possessed a longer MRT, compared to Chinese product.
出处
《中国计划生育学杂志》
1992年第2期31-33,64,共4页
Chinese Journal of Family Planning
