和胃降逆胶囊的质量控制研究  

Quality control for Hewei Jiangni Capsules

作　　者：权利娜[1] 黄冕 樊强强 翟秉涛 邹俊波[1] 程江雪[1] 赵宗平 郭东艳[1] QUAN Li-na;HUANG Mian;FAN Qiang-qiang;ZHAI Bing-tao;ZOU Jun-bo;CHENG Jiang-xue;ZHAO Zong-ping;GUO Dong-yan(State Key Laboratory of Research&Development of Characteristic Qin Medicine Resources(Cultivation),Shaanxi Key Laboratory of Chinese Medicine Fundamentals and New Drugs Research,Shaanxi University of Chinese Medicine,Xianyang 712046,China;Shaanxi Weixin Pharmaceutical Co.,Ltd.,Xi'an 710065,China)

机构地区：[1]陕西中医药大学秦药特色资源研究与开发国家重点实验室(培育)陕西省中药基础与新药研究重点实验室,陕西咸阳712046 [2]陕西威信制药有限公司,陕西西安710065

出　　处：《现代药物与临床》2022年第6期1228-1233,共6页Drugs & Clinic

基　　金：陕西省教育厅科研服务地方专项计划项目(15JF015);陕西中医药大学学科创新团队项目(2019-YL11)。

摘　　要：目的建立和胃降逆胶囊的质量标准,为全面提升和胃降逆胶囊的质量控制提供参考。方法采用薄层色谱(TLC)法定性鉴别和胃降逆胶囊中朱砂七、楤木和蒲公英,采用滴定法测定煅赭石中铁(Fe),采用高效液相色谱法(HPLC)测定虎杖苷、大黄素、白藜芦醇、大黄素-8-O-β-D-葡萄糖苷和大黄素甲醚。结果朱砂七、楤木和蒲公英的TLC特征斑点清晰,专属性强,分离度好,阴性对照无干扰;样品中Fe的范围为130.665~140.823 mg/g;虎杖苷、大黄素、白藜芦醇、大黄素-8-O-β-D-葡萄糖苷和大黄素甲醚在0.0714~1.7143、0.0357~0.8572、0.0714~1.7143、0.0357~0.8572、0.0143~0.3428μg与峰面积呈良好的线性关系,平均加样回收率分别为97.26%、96.28%、100.36%、102.71%、101.36%,RSD值分别为0.81%、2.25%、1.71%、2.85%、2.38%。结论建立的方法可作为和胃降逆胶囊的质量标准。Objective To establish the quality standard of Heweijiangni Capsules,to provide reference for the overall improvement of the quality control of Heweijiangni Capsules.Methods TLC method was used to qualitatively identify the Polygoni Ciliinerve Radix,Aralae Cortex,and Taraxaci Herba in Hewei Jiangni Capsules.The content of iron(Fe)in was determined by titration.HPLC method was used to determine polydatin,emodin,resveratrol,emodin-8-O-β-D-pyranoside,and physcion.Results TLC spots of Polygoni Ciliinerve Radix,Aralae Cortex,and Taraxaci Herba were clear,the separation was good,the specificity was strong,and the negative sample had no interference.The content of Fe in the sample was 130.665—140.823 mg/g.The linear ranges of polydatin,emodin,resveratrol,emodin-8-O-β-D-pyranoside,and physcion in Hewei Jiangni Capsules were 0.0714—1.7143μg,0.0357—0.8572μg,0.0714—1.7143μg,0.0357—0.8572μg,and 0.0143—0.3428μg,respectively.The average recoveries were 97.26%,96.28%,100.36%,102.71%,and 101.36%,with RSD values 0.81%,2.25%,1.71%,2.85%,and 2.38%,respectively.Conclusion The established method can be used as quality standard of Hewei Jiangni Capsules.

关 键 词：和胃降逆胶囊 朱砂七 楤木 蒲公英 虎杖苷 大黄素 白藜芦醇 铁 

分 类 号：R286.02[医药卫生—中药学]