孕酮阴道环体外释放度的研究

Study on the Release Quantity of Progesterone Vagina Ring in vitro

目的:测定并比较自制孕酮阴道环和进口孕酮阴道环的体外释放度。方法:采用HPLC分析法进行体外释放实验,十八烷基键合硅胶为填充剂,以甲醇:水(63∶37)为流动相,流速为1.0ml/min,检测波长254nm。结果:自制孕酮阴道环的d7释药量和90d的平均释药量分别为10.5mg/d、9.0mg/d,进口孕酮阴道环的d7释药量和90d的平均释药量分别为10.4mg/d、9.2mg/d。结论:自制孕酮阴道环和进口孕酮阴道环体外释药量基本一致。

Objective： To determine and compare the release quantity of homemade progesterone vagina ring in vitro with that of import progesterone vagina ring. Methods： A HPLC method was developed for the quantitative determination of release quantity of progesterone vagina ring in vitro. The operation was carried out in the ODS-C18 column with the mobile phase consisting of a mixture of methanol-water（63 ： 37）. The detection was done at 254 nm and the flow rate was 1.0 ml/min. Results： The release quantity of homemade progesterone vagina ring in vitro in d 7 was 10.5 mg/d and the mean of quantity release in 90 d was 9.0 mg/d. The release quantity of import progesterone vagina ring in vitro in d 7 was 10.4 mg/d and the mean of quantity release in 90 d was 9.2 mg/d. Conclusion： The release quantity of homemade progesterone vagina ring in vitro was consistent with that of import progesterone vagina ring. The function of them is similar.