阴道海绵栓“羊乐”中醋酸氟孕酮体外释放规律研究  

The release dynamic of fluorogestone acetate(FGA) intravaginal sponges Yangle in vitro

作　　者：何晓红[1] 杨利国[1] 

机构地区：[1]南京农业大学动物繁育研究所,江苏南京210095

出　　处：《南京农业大学学报》2002年第2期75-78,共4页Journal of Nanjing Agricultural University

基　　金：国家农业科技跨跃计划 (2 0 0 114 ) ;江苏省农业三项工程 [SX(2 0 0 1) 0 47]

摘　　要：根据Martindale药典中的体外释放方法 ,研究分别含醋酸氟孕酮 (FGA) 30 ,4 0和 5 0mg的“羊乐”和法国产品Synchropart在 12d内释放FGA的规律。结果发现 ,3种规格的“羊乐”和Synchropart中FGA每天释放量均呈下降趋势 ,12d内各剂量组释放量的平均值分别为 2 0 1± 1 0 3,2 2 0± 1 2 2 ,3 2 1± 0 88和 2 0 9± 0 4 0mg·d-1。在第 3和第 4天 ,各剂量组FGA释放量达到高峰 ,以后释放量逐渐降低 ,至第 12天各剂量组的释放量最低。回收实验中 ,各剂量组的回收率分别为 88 2 3% ,86 4 8% ,99 4 0 %和 90 0 0 %。运用SPSS软件分析FGA海绵栓的释放模型 ,发现释放量y1、y2 、y3 和y法国 (分别表示 3种规格的“羊乐”和Synchropart的FGA释放量 )与释放时间 (d)关系如下 :y1=3 6 4 36 - 0 2 5 17d ;y2 =3 6 718- 0 2 2 6 0d ;y3 =3 9390 - 0 112 9d和y法国 =2 5 5 0 5 - 0 0 70 5d。According to the description of Martindale pharmacopoeia,the release dynamic of fluorogestone acetate(FGA)in intravaginal sponges containing 30,40 or 50 mg of FGA and Synchropart(from France)individually was studied in vitro for 12 days.The results showed that there was no differences among four types of sponges and decreased gradually day by day for the release amount of FGA.The average release amount of four types of sponges was 2 01±1 03,2 20±1 22,3 21±0 88 and 2 09±0 40 mg·d -1 ,respectively.The release amount of FGA reached the top on day 3 and 4,and then lowed gradually and reached the bottom on day 12.In the recycling trials,the recycling rates for four types of sponges were 88 23%,86 48%,99 40% and 90 00%,respectively.The formulas of FGA release amount for type 1,2,3 and Synchropart of sponges(presented iny 1,y 2,y 3 and y (France) )were y 1=3 643 6-0 251 7 d, y 2= 3 671 8-0 226 0 d,y 3=3 939 0-0 112 9 d,and y France =2 550 5-0 070 5 d(where d represented the day observed).

关 键 词：阴道海绵栓 “羊乐” 醋酸氟孕酮 体外释放规律 释放量 释放模型 释放时间 

分 类 号：R965.2[医药卫生—药理学]