妇科止带片的体外溶出度比较

目的 比较不同生产厂家妇科止带片的体外溶出情况,为临床用药提供参考.方法 参照日本“药品品质再评价”在溶出度中所拟定的模拟人体消化道内体液的4种溶出介质及溶出度实验条件的规定,考察了不同药厂妇科止带片在4种溶出介质中的体外溶出情况,并进行了比较.结果 7家药厂的妇科止带片只有1家的在4种溶出介质中的溶出状况均较好,且在60 min时,在溶出介质Ⅰ、Ⅳ条件下的累积溶出百分率大于65％,在溶出介质Ⅱ、Ⅲ条件下的累积溶出百分率大于80％;其他药厂的妇科止带片在4种溶出介质中的溶出状况不尽相同.在溶出介质Ⅱ、Ⅲ的条件下,7家药厂的妇科止带片在60 rmin时的累积溶出百分率均大于65％,综合比较,在溶出介质Ⅲ条件下的溶出状况较佳.结论 不同厂家生产的妇科止带片的体外溶出差异较大;其质量水平差异显著.

Comparison of the dissolution of Fuke Zhidai tablets

OBJECTIVE By comparing the dissolution of Fuke Zhidai tablets (FZT) from different manufacturers,this study aims to provide more scientific reference for clinical medication.METHODS According to Japan's drug quality's reevalution in dissolution to simulate 4 kinds of dissolution medium conditions of human body fluids in the digestive tract,and dissolution experiment,the study were conducted to determine FZT from different pharmaceutical factories in four kinds of dissolution medium in vitro.RESULTS FZT from only one factory out of seven had good dissolution in the four different mediums.At 60 min,it had more than 65 ％ cumulative dissolution under medium Ⅰ and Ⅳ,and more than 80％ under medium Ⅱ and Ⅲ.FZTs form other factories all had different dissolution in 4 dissolution mediums and conditions.CONCLUSION FZTs made by different manufacturers showed significantly targe differences in their in vitro dissolution and quality.