论文部分内容阅读
该研究是中药生物药剂学分类系统(biopharmaceutics classification system of Chinese materia medica,CMMBCS)用于中成药评价的实例,重点评估可能影响多成分吸收时序的溶出同步性问题。实验采用HPLC测定复方葛根芩连片中9种成分在不同溶出介质中不同时间点的累积溶出百分率,绘制体外溶出曲线,采用相似因子(f2)和聚类分析进行溶出曲线的相似性比较分析,结果表明在水介质中,峰7和峰8(黄芩苷)所代表的成分与2号参比峰(葛根素)相似性较差,相似因子均为43;在p H 7.4介质中,峰7和峰8(黄芩苷)所代表的成分与2号参比峰(葛根素)相似性较差,相似因子分别为31和45;其他介质中各峰所代表的成分与2号参比峰(葛根素)均相似性较好。该实验表明峰3,4,5和6(小檗碱)所代表的成分与2号参比峰(葛根素)具有完全同步溶出的特性;峰1和峰9所代表的成分与2号参比峰(葛根素)具有基本完全同步溶出的特性;峰7和峰8(黄芩苷)所代表的成分与2号参比峰(葛根素)不具有同步溶出的特性。
This study is an example of biopharmaceutics classification system of Chinese materia medica (CMMBCS) used in the evaluation of proprietary Chinese medicines, focusing on the issue of dissolution synchronization that may affect the multi-component absorption timing. In the experiment, the cumulative dissolution rates of nine components in different doses of Gegenqinlian contiguous tablet in different dissolution media were determined by HPLC, the in vitro dissolution curves were plotted, the similarities of the dissolution curves were analyzed by similarity factor (f2) and cluster analysis, The results showed that the similarity between peak 7 and peak 8 (baicalin) and reference peak No. 2 (puerarin) in aqueous medium was poor with similarity factors of 43; in p H 7.4 medium, peak 7 And peak 8 (baicalin) and the reference peak No. 2 (puerarin) similarity of poor similarity factors were 31 and 45; other media in the peak represented by the composition and the reference peak No. 2 ( Puerarin) are similar to better. This experiment shows that the components represented by peaks 3, 4, 5 and 6 (berberine) and the reference peak No. 2 (puerarin) have completely synchronous dissolution characteristics; the components represented by peaks 1 and 9 and the parameters 2 The peak (puerarin) had a substantially complete simultaneous dissolution profile; the components represented by peaks 7 and 8 (baicalin) did not exhibit synchronous dissolution with reference peak No. 2 (puerarin).