粉葛标准汤剂质量评价体系的建立  

Quality Evaluation System of Standard Decoction of Puerariae Thomsonii Radix

作　　者：张妍林 孟庆红 孙奕[2] 范自全 王丹丹 花尔并[1] ZHANG Yan-lin;MENG Qing-hong;SUN Yi;FAN Zi-quan;WANG Dan-dan;HUA Er-bing(College of Biotechnology, Tianjin University of Science & Technology,Tianjin 300457,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences ,Beijing 100700,China;Waters Technologies ( Shanghai) Co. Ltd., Shanghai 201206,China)

机构地区：[1]天津科技大学生物工程学院,天津300457 [2]中国中医科学院中药研究所,北京100700 [3]沃特世科技(上海)有限公司,上海201206

出　　处：《中国实验方剂学杂志》2019年第9期144-149,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金青年科学基金项目(81502968)

摘　　要：目的:建立粉葛标准汤剂质量控制方法。方法:根据中药饮片标准汤剂制备原则,在该研究建立的色谱条件下,分析了收集的13批不同产地的粉葛饮片,并进行方法学验证。参照2015年版《中国药典》以葛根素作为定量指标,并计算转移率。该研究还对主要色谱峰进行结构确认,明确了粉葛标准汤剂中的主要化学成分。结果:13批药材经鉴定均为粉葛(Pueraria thomsonii),加样回收率为98.0%,RSD为1.1%,表明该方法准确可靠。转移率的范围为41.4%~60.0%,出膏率范围为15.7%~34.3%,对13批粉葛饮片标准汤剂制作出了相应的指纹图谱,其相似度均>90.0%。通过使用质谱分析共鉴定出了粉葛中的柠檬酸,葛根素-4’-O-葡萄糖苷,大豆黄素-4’,7-双葡萄糖苷,染料木素苷,葛根素,葛根素芹菜糖苷,大豆苷,葛苷A,大豆素等多种化学成分。结论:13批不同产地的粉葛标准汤剂与粉葛饮片的基本属性一致,建立的质量评价方法可以用于系统评价粉葛标准汤剂,为粉葛水煎液相关制剂质量控制提供了参考。Objective: To establish the quality control methods for the standard decoction of Puerariae Thomsonii Radix. Method: According to the preparation principles for traditional Chinese medicine( TCM)standard decoction,13 batches of Puerariae Thomsonii Radix from different origins were analyzed under the chromatography conditions established in this study and verified with methodology. By referring to Chinese Pharmacopoeia of 2015,puerarin was used as a quantitative indicator to calculate the transfer rate. In this study,the structures of main chromatographic peaks were also identified to clarify the main chemical constituents in the standard decoction. Result: The 13 batches of medicinal herbs were identified as Puerariae Thomsonii Radix,with a recovery rate of 98. 0%,and RSD of 1. 1%,indicating that the method was accurate and reliable. The transfer rate ranged from 41. 4% to 60. 0%, and the extraction rate was within the range of 15. 7%-34. 3%. The corresponding fingerprints were prepared for 13 batches of the standard decoction,and their similarities were all greater than 90. 0%. The chemical constituents from Puerariae Thomsonii Radix were identified by mass spectrometry analysis, including citric acid, 4’-O-glucosyl puerarin/daidzein-4’, 7-diglucoside, 3’-hydroxy puerarin/genistein puerarin, puerarin apioside, daidzin puerossid A and daidzein, etc. Conclusion: The 13 batches of Puerariae Thomsonii Radix decoction in different origins had consistent properties with the basic properties of medicinal decoction pieces. The established method of quality evaluation can be used to systematically evaluate the standard decoction,providing reference for quality control of related decoction preparations of Puerariae Thomsonii Radix.

关 键 词：粉葛 质量评价方法 标准汤剂 葛根素 转移率 指纹图谱 

分 类 号：R284.1[医药卫生—中药学] R289[医药卫生—中医学]