基于标准汤剂的紫苏梗配方颗粒质量标准研究  

Quality study of Perillae caulis formula granules based on standard decotion

作　　者：杨洁 吕渭升 陈芳 邓立萍 师若云 段志文 何民友 魏梅 李振雨 Yang Jie;Lyu Weisheng;Chen Fang;Deng Liping;Shi Ruoyun;Duan Zhiwen;He Minyou;Wei Mei;Li Zhenyu(Guangdong E-fong Pharmaceutical Co.,Ltd.,Key Laboratory of Traditional Chinese Medicine Formula of Guangdong Province,Foshan 528244,China)

机构地区：[1]广东一方制药有限公司,广东省中药配方颗粒企业重点实验室,佛山528244

出　　处：《国际中医中药杂志》2022年第10期1144-1149,共6页International Journal of Traditional Chinese Medicine

基　　金：国家工业和信息化部产业技术基础公共服务平台项目(2019-00902-1-2);佛山市应急科技攻关专项(2020001000206);佛山市科技创新项目(2120001002309)。

摘　　要：目的建立基于标准汤剂三大质量指标的紫苏梗配方颗粒质量评价方法。方法收集18批不同产地的紫苏梗药材,根据技术要求,制备18批紫苏梗标准汤剂及3批配方颗粒,计算出膏率;采用超高效液相色谱法(UPLC)测定咖啡酸和迷迭香酸含量、建立紫苏梗标准汤剂和配方颗粒的特征图谱,并计算二者特征图谱的相似度。结果紫苏梗标准汤剂出膏率为(7.16±1.97)%。3批配方颗粒的出膏率分别为5.52%、5.25%和5.34%;标准汤剂的咖啡酸与迷迭香酸平均总含量为(12.06±3.37)mg/g;3批配方颗粒的咖啡酸与迷迭香酸总含量分别为5.52、5.82、5.77 mg/g。标准汤剂和配方颗粒特征图谱均标识出7个共有特征峰,指认出其中3个特征峰,分别为咖啡酸、N-阿魏酰真蛸胺、迷迭香酸。配方颗粒与标准汤剂对照特征图谱的相似度分别为1.000、0.995、0.997。结论3批配方颗粒的质量指标与标准汤剂相一致,该方法可为紫苏梗配方颗粒质量标准的制定提供依据。Objective To establish the quality evaluation method of Perillae caulis formula granules based on the three kind of quality indexes of standard decoction.Methods Eighteen batches of Perillae caulis were collected from different habitats according to different technical requirements,eighteen batches of standard decoction and three batches of formula granules were prepared and the paste-forming rates were calculated.The content of Caffeic acid and Rosmarinic acid were determined and calculated by Ultra High Performance Liquid Chromatography(UPLC).Then the fingerprints of standard decoction of and formula granules of Perillae caulis were established by UPLC.The similarity values of fingerprints between formula granules and standard decoction were calculated.Results The average paste-forming rate of standard decoction was(7.16±1.97)%.The paste-forming rates of three batches of formula granules were 5.52%,5.25% and 5.34%,respectively.The average content of Caffeic acid and Rosmarinic acid in standard decoction was(12.06±3.37)mg/g.The contents of three batches of formula granules were 5.52,5.82,5.77 mg/g,respectively.Seven common fingerprint peaks were identified in the fingerprints of standard decoction and formula granules,three of which were identified as Caffeic acid,N-Feruloyl Octopus amine and Rosmarinic acid by comparison of reference substance.The fingerprints similarity of Perillae caulis dispensing granules and standard decoction were 1.000,0.995 and 0.997,respectively.Conclusions The quality indexes of three batches of formulation granules are consistent with standard decoction.This method can provide basis for the establishment of quality standard of Perillae caulis dispensing granules.

关 键 词：紫苏梗 标准汤剂 配方颗粒 质量控制 

分 类 号：R286.0[医药卫生—中药学]