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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 in vitro dissolution of gliclazide tablets from 5 manufacturers, to provide reference for controlling its quality. Methods: The spin-basket method was selected, and statistical analysis of T_ (50), T_d and other parameters were carried out. Results: The difference between the dissolution rates at 60 min and 50% of the labeled amount was significant at each manufacturer’s preparation. The dissolution rate at 180 min exceeded 75% of the labeled amount. The ANOVA showed that T_ (50) and T_d were significant Sex differences. Conclusion: There are significant differences in in vitro dissolution of gliclazide tablets from different manufacturers.