气血并治方制剂中间体的质量控制

Study on quality control of effective fraction in Qixue Bingzhi decoction

目的:建立气血并治方制剂中间体指纹图谱分析及有效成分含量测定方法,探讨中药复方制剂中间体质量控制的有效途径。方法:建立制剂中间体指纹图谱定性分析和多种有效成分定量分析HPLC法,定性、定量分析相结合控制制剂中间体的质量。结果:经方法学认证,含量测定和指纹图谱分析各项参数均符合要求;10批制剂中间体样品含量分析显示,芍药苷、柚皮苷及新橙皮苷的含量在12 .5 %～16 . 0 % ,8 4 %～12 .4 % ,12 . 8%～15. 3% ,平均含量分别为(14 7±1 .1) % ,(10 . 6±1 2 ) % ,(14 . 2±0 . 8) % (n =10 ) ;各批次样品指纹图谱分析都显示2 5个共有峰,与标准谱图比较,指纹图谱相似度在99.0 %以上。结论:该方法测定结果准确、重复性好,可对气血并治方制剂中间体进行有效质量控制。

Objective: To develop a method for quality control of effective fraction in Qi-Xue-Bing-Zhi decoction, a traditional Chinese medicine (TCM). Method: PF samples, effective fraction from Qi-Xue-Bing-Zhi decoction, were used as example, and a HPLC assay for chemical fingerprint and quantitative analysis was established. Result: The contents range of Paeoniflorin (PE), Naringin (NG) and Neohesperidin (NH) in effective fractions were changed from 12.5%-16.0%, 8.4%-12.4%, 12.8%-15.3%, and their average contents were (14.7±1.1)%, (10.6±1.2)%, (14.2±0.8)% (n=10),respectively. The fingerprints of PF samples showed 25 common peaks, and the fingerprint similarity for PF samples were all above 99.00% by comparing with the standard chromatogram. Conclusion: The method reported could be used effectively for the quality control of effective fraction from TCM.