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目的建立复方甘草酸苷片三组分的体外溶出度测定方法。方法桨法,蒸馏水为溶出介质,用HPLC检测,计算累积溶出百分率,提取溶出参数(T50,Td,m)进行统计分析,并采用相似因子法评价试验药品和进口对照药品溶出度的相似程度。结果两种制剂中三组分的溶出参数均无差异(P>0.05),相似因子f2分别为81.3,75.2,77.3。结论本研究建立的溶出度测定方法简便、准确、重复性好,可用于复方甘草酸苷片的质量控制。两种制剂的体外溶出特性相似,提示试验药品的生产工艺稳定,可靠。
Objective To establish a method for the in vitro dissolution test of compound glycyrrhizin tablets. Methods The paddle method and distilled water were used as dissolution medium. The percentage of cumulative dissolution was calculated by HPLC. The dissolution parameters (T50, Td, m) were extracted for statistical analysis. Similarity method was used to evaluate the similarity of dissolution rate of test drug and imported control drug. Results There was no difference in the dissolution parameters of the three components between the two preparations (P> 0.05). Similar factors f2 were 81.3, 75.2 and 77.3 respectively. Conclusion The dissolution assay established in this study is simple, accurate and reproducible. It can be used for the quality control of compound glycyrrhizin tablets. In vitro dissolution characteristics of the two preparations are similar, suggesting that the production process of test drugs is stable and reliable.