复方甘草酸苷片的溶出度研究

Study on the Dissolution of Compound Glycyrrhizin Tablets

关键词:  复方甘草酸苷片  高效液相色谱法  溶出度  相似因子法

Key words:  compound glycyrrhizin tablets  HPLC  dissolution  similar factor

摘要:

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。

Abstract:

OBJECTIVE To establish the dissolution method for the three compositions of compound glycyrrhizin tablets. METHODS According to Ch.P (2005) dissolution method ΙΙ and using distilled water as the dissolution medium. The dissolution of compound glycyrrhizin tablet was determined by HPLC. The parameters(T50, Td, m)obtained from the dissolution tests were analysed. Degree of similarity of the dissolution was assessed using trial drugs and controlled drug. RESULTS There were no significant differences in dissolution parameters between trial drugs and controlled drugs(P>0.05). The dissolution of the three compositions of trial drugs was similar to controlled drug. The similar factor was 81.3, 75.2 and 77.3, respectively. CONCLUSION The method is simple, accurate and well reproducible. It can be used as a reliable method for the quality control of compound glycyrrhizin tablets. The dissolution characters of trial drugs similar with controlled drugs. The results show that the technology of producting trial drugs was stable and reliable.