基于传统煎药工艺的川牛膝饮片标准汤剂制备及质量评价方法研究  

Study on Preparation and Quality Evaluation of the Standard Decoction of Radix Cyathulae Based on Traditional Decocting Process

作　　者：孙博 常阿倩[3] 朱广伟 徐腾腾[4] 曲缘章 李西文 李琦[5] 杉田亨 友田健久 Sun Bo;Chang Aqian;Zhu Guangwei;Xu Tengteng;Qu Yuanzhang;Li Xiwen;Li Qi;Toru Sugita;Takehisa Tomoda(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Harbin University of Commerce,Harbin 150076,China;Beijing University of Chinese Medicine,Beijing 100102,China;Shandong University of Traditional Chinese Medicine,Jinan 250355,China;Shanghai Traditional Chinese Medicine Co.,Ltd.,Shanghai 200002,China;Tsumura Corporation,Tokyo 107-8521,Japan)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]哈尔滨商业大学,哈尔滨150076 [3]北京中医药大学,北京100102 [4]山东中医药大学,济南250355 [5]上海市药材有限公司,上海200002 [6]日本国株式会社津村,东京107-8521

出　　处：《世界中医药》2019年第12期3144-3149,共6页World Chinese Medicine

基　　金：标准汤剂、中药配方颗粒国家标准和药材DNA条形码鉴定体系研究(H2016021-06)

摘　　要：目的:制备来自于不同产地的15批次川牛膝饮片标准汤剂,并以其出膏率、指标成分含量及转移率、指纹图谱等数据为指征进行研究。方法:参照传统煎药工艺制备标准汤剂,采用UPLC-DAD法测定指标成分含量,计算转移率、出膏率及指纹图谱数据研究。结果:15批次川牛膝样品制成的标准汤剂中杯苋甾酮含量为0.066~0.210 mg/mL,转移率为61.27%~99.69%,平均转移率为73.27%,标准偏差为11.88%。出膏率范围为17.66%~31.45%,平均出膏率为24.48%,标准偏差为4.54%。指纹图谱共有峰11个,确认1个,为杯苋甾酮(C29H44O8)。结论:本研究建立的制备工艺符合传统汤剂制备方法,且稳定可行,可用于川牛膝饮片标准汤剂的制备及质量评价,并为配方颗粒、经典名方研究及工业化生产提供基本的数据支撑和参考。Objective:To evaluate the extraction ration,content determination,transfer ration,and feature maps or fingerprints by establishing 15 batches of standard decoction of Radix Cyathulae from different places.Methods:The standard decoction was prepared based on the traditional decoction process,the content of index components,the extraction ration,the transfer ration and the fingerprints were evaluated by UPLC-DAD.Results:The determination of cyasterone in 15 batches of standard decoration was in the range of 0.066~0.210 mg/mL,the transfer rate of cyasterone was in the range of 61.27%~99.69%,the average transfer rate was 73.27%,and the standard deviation was 11.88%.The extraction rate was in the range of 17.66%~31.45%,the average extraction rate was 24.48%and the standard deviation was 4.54%.11 peaks of fingerprint were confirmed in this research,and cyasterone was identified as cyasterone(C29H44O8).Conclusion:The preparation method in this paper is consistent with the traditional preparation method,which is stable and feasible.It can be used for the standard preparation and quality evaluation of the standard decoction of Radix Cyathulae.It is also able to provide both basic data and reference in the research and industrial production of dispensing granule and classical prescription.

关 键 词：川牛膝 标准汤剂(标准煎液) 配方颗粒 UPLC-DAD 指纹图谱 杯苋甾酮 转移率 经典名方 

分 类 号：R944.61[医药卫生—药剂学] R283.6[医药卫生—药学]