长效避孕栓溶出度试验研究  

The study of dissolution rate of the long - acting suppository contraceptive.

作　　者：邵长凤[1] 陈坚[1] 张颖[1] 沈丽琳[1] 

机构地区：[1]天津市计划生育研究所,300191

出　　处：《中国计划生育学杂志》1999年第9期390-391,共2页Chinese Journal of Family Planning

基　　金：国家计生委资助

摘　　要：本文对长效避孕栓进行体外溶出度测定。溶出度试验条件选择在溶出度5分钟达到35％以上,3小时达到60％～80％以上,6小时达到90％以上。用高效液相色谱法测定溶出样品液的浓度。结果表明:测定的三批样品溶出度均符合要求。认为本方法可满足该栓剂体外溶出度测定要求,可用于控制该产品制剂工艺,以保证产品质量。This paper reports the study on the dissolution rate test of the suppository contraceptive, a domestic nonoynol, producted by this Institute in vitro. It has to meet the requirements that the dissolution rate is over 35% within 5 min,60% - 80% within 3h and over 90% within 6h . The concentration of the sample solution waw determined by HPLC. The results revealed that our experiment met the requirements and the method can be used to monitor the technological process in suppository contraceptive production , and ensure for the product quality.

关 键 词：长效避孕栓 壬苯醇醚-9 溶出度 高效液相色谱 

分 类 号：R979.21[医药卫生—药品] R944.9[医药卫生—药学]