连翘标准汤剂质量评价体系的建立  

Quality Evaluation of Standard Decoction of Forsythiae Fructus

作　　者：曹静亚 李晓[2,3] 宋梦娇[1,2] 魏悦 张丽先 李智宁 李自红[1,2] 陈玲 CAO Jing-ya1,2, LI Xiao2,3, SONG Meng-jiao1,2, WEI Yuel,2, ZHANG Li-xian1,2, LI Zhi-ning1,2, LI Zi-hong1,2, CHEN Ling2,3.(1. Henan Cogo Testing International Standardizing Technology Co. Ltd. , Zhengzhou 450002, China ; 2. Biological Developing Center of Henan Academy of Sciences, Zhengzhou 450002, China; 3. Henan Plant Natural Products Development Engineering Research Center, Zhengzhou 450002, Chin)

机构地区：[1]河南科高中标检测技术有限公司,郑州450002 [2]河南省生物技术开发中心,郑州450002 [3]河南省植物天然产物开发工程技术研究中心,郑州450002

出　　处：《中国实验方剂学杂志》2018年第7期7-12,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：河南省科技攻关项目(162102310345,172102310345)

摘　　要：目的：制备连翘标准汤剂并进行其质量标准研究。方法：根据标准汤剂的制备要求，制备16批连翘标准汤剂，以连翘苷、连翘酯苷A作为定量检测指标，计算指标成分转移率与出膏率，建立其HPLC指纹图谱分析方法。结果：通过对16批连翘标准汤剂进行测定，建议连翘标准汤剂出膏率范围13．61％～25．27％；连翘苷转移率范围58．61％～100．00％；连翘酯苷A转移率范围27．88％～51．78％。利用“中药色谱指纹图谱相似度评价系统”（2012版）软件进行指纹图谱分析，标定了共有峰10个，分析确认了6个色谱峰，分别为forsythensideF（3号峰），连翘酯苷I（4号峰），（＋）松脂醇-4-01B-D-吡喃葡萄糖苷（5号峰），连翘酯苷A（6号峰），连翘苷（7号峰）和连翘脂素（10号峰）。采用特征峰评价模式，以峰7作为s峰，规定上述6个特征峰与s峰的相对保留时间分别为0．47，0．52，0．67，0．71，1．00，1．27。结论：本研究成功建立了连翘标准汤剂的质量评价方法，该方法准确、重复性好、特征性强，可为连翘配方颗粒的质量控制提供参考。Objective： To prepare standard decoction of Forsythiae Fructus and establish its quality standard. Method： Sixteen hatches of standard decoction of Forsythiae Fructus were prepared according to the standardization method. With forsythin and forsythoside A as detection indexes, the transfer rates of index components and extraction rates were calculated and the HPLC fingerprint analysis method was established. Result： Through the measurement of 16 batches of standard decoction of Forsythiae Fructus, the extraction rate was ruled from 13.61% to 25.27% , the transfer rates of forsythin and forsythoside A were defined as 58.61% -100.00% and 27.88%-51.78% , respectively. Besides, the similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine （version 2012） was used to analyze the fingerprint, ten common peaks were determined and six were calibrated, including forsythenside F （peak 3）, forsythoside I （peak 4）, （＋）pinoresinol 4-O-β-D-glucopyranoside （peak 5 ）, forsythoside A （ peak 6）, forsythin （ peak 7） and phillygenin （peak 10） ; taking the characteristic peak evaluation model, the relative retention time of each characteristic peak were defined as 0.47, 0. 52, 0.67, 0.71, 1.00, 1.27 with peak 7 as a reference. Conclusion： This study establishes a method for the quality evaluation of standard decoction of Forsythiae Fructus. The method is accurate, reproducible and characterized. Therefore, it can provide a reference for the quality control of Forsythiae Fructus dispensing granules.

关 键 词：连翘 标准汤剂 指纹图谱 质量标准 转移率 出膏率 连翘苷 

分 类 号：R22[医药卫生—中医基础理论] R289[医药卫生—中医学]