决明子标准汤剂质量评价研究

Quality Evaluation of Cassia Semen Standard Decoction

目的制备决明子标准汤剂并评价其质量。方法通过对21批不同产地决明子饮片的质量考察,将其中符合2015年版《中国药典(一部)》规定的15批饮片按《医疗机构中药煎药室管理规范》制备决明子标准汤剂,测定出膏率;采用高效液相色谱-二极管阵列检测器(HPLC-DVD)法建立标准汤剂指标成分含量测定及特征指纹图谱分析方法,并计算橙黄决明素、大黄酚转移率。结果标准汤剂出膏率为(12. 32±1. 35)%,转移率橙黄决明素为(84. 92±2. 57)%、大黄酚为(23. 82±0. 97)%;特征指纹图谱共有峰10个,指认出橙黄决明素、芦荟大黄素、黄决明素、大黄素、大黄酚及大黄素甲醚6个主要成分,指纹图谱批次间相似度均大于0. 90。结论所建立的特征指纹图谱和多指标成分定量分析方法准确、快速,可用于决明子标准汤剂整体质量的控制。

Objective To prepare standard decoction of cassia semen and study the quality evaluation.Methods Through the examination of the quality of 21 batches of Cassia Semen pieces from different origins,the 15 batches of decoction that met the requirements of the Chinese Pharmacopoeia(2015 edition)were prepared for standard decoction of cassia semen according to the Standard for Management of TCM Decoction Rooms of Medical Institutions and then measured the extraction rate.The high performance liquid chromatography-diode array detector(HPLC-DVD)method was adopted to establish the standard decoction index content determination and characteristic fingerprint analysis method,and the transfer rate of aurantio-obtusin and chrysophanol was calculated.Results The results showed that the extraction rate was(12.32±1.35)%;the aurantio-obtusin transfer rate was(84.92±2.57)%,and the chrysophanol transfer rate was(23.82±0.97)%.The characteristic fingerprints had a total of 10 peaks,which identified six main components of aurantio-obtusin,aloe-emodin,lycopene,emodin,chrysophanol and physcion.The similarity between fingerprint batches was higher than 0.90.Conclusion The established characteristic fingerprint and multi-index quantitative analysis methods are accurate and fast,and can be used to control the overall quality of cassia semen standard decoction.