摘要
目的:比较5个厂家市售格列齐特片的体外溶出度,为控制其质量提供参考。方法:选用转篮法,并对T_(50)、T_d等参数进行统计分析。结果:各厂家制剂之间在60 min的溶出量与标示量的50%比较差距较大,在180 min时的溶出量均超过标示量的75%,方差分析显示T_(50)、T_d具有显著性差异。结论:不同厂家的格列齐特片的体外溶出存在显著性差异。
Objective： To compare the in vitro dissolution of glielazide tablets from four domestic pharmaceutical factories and one abroad factory. Method： Basket was used, and the variance of T50, Td were also analyzed. Result： The dissolution amount of all the tablets was more than 75% at 180min, but compared with 50% of nominal amount, they were different in the dissolution amount of them at 60min. Statistic results showed that there were significant differences in T50 .Td among these products by anova analysis. Conclusion： It is suggested that there are apparent differences among different factories in this dissolution test.
出处
《中国药师》
CAS
2008年第11期1315-1317,共3页
China Pharmacist
关键词
格列齐特片
溶出度
转篮法
Gliclazide tablets
Dissolution
Basket
