廖卫国,朱红霞,刘强,王利胜,余健烨,梁秀清,李周,黄德浩,黄志刚
LIAO Weiguo,ZHU Hongxia,LIU Qiang,WANG Lisheng,YU Jianye,LIANG Xiuqing,LI Zhou,HUANG Dehao,HUANG Zhigang

• 1:广州中医药大学中药学院
• 2:南方医科大学中西医结合医院
• 3:广东省惠州市九惠制药股份有限公司

摘要(Abstract)：

目的建立超微田七痛经胶囊的质量控制方法。方法采用薄层色谱法对处方中三七、延胡索、木香、小茴香、蒲黄、五灵脂、冰片进行定性鉴别;高效液相色谱法同时测定制剂中三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1的含量。结果处方中各药味的薄层鉴别分离度好,专属性强;HPLC的线性关系良好;三七皂苷R1、人参皂苷Rg1、人参皂苷R b1的平均回收率分别为100.6%、99.9%、100.4%,RSD分别为1.1%、1.7%、1.1%。结论所建立的方法可靠,重现性好,可以应用于定性、定量地控制超微田七痛经胶囊的质量。
OBJECTIVE To establish a method for quality control standard of ultramicro powder of Tianqi Tongjing capsules.METHODS Radix Notoginseng,Rhizoma Corydalis,Radix Aucklandiae,Fructus Foeniculi,Pollen Typhae,Faeces Trogopterori,Borneolum Syntheticum in ultramicro powder of Tongjing capsules were identified by TLC. Gensenoside Rg1,Gensenoside Rb1 and Notogensenoside R1 were determined by HPLC. RESULTS A variety of drug in prescription can be identified with a good separating degree and strong specificity by TLC. HPLC had good linear behavior. The average recovery of Notogensenoside R1 was 100. 6% and RSD was 1.1%. The average recovery of Gensenoside Rg1 was 99.9% and RSD was 1.7%. The average recovery of Gensenoside Rb1was100.4% and RSD was 1. 1%. CONCLUSION The method is reliable and reproducible. It can be used for the quality control of ultramicro powder of Tianqi Tongjing capsule.

关键词(KeyWords)： 超微田七痛经胶囊;质量标准;三七皂苷R1;人参皂苷Rgl;人参皂苷Rb1
Ultramicro powder of Tianqi Tongjing capsule;quality standard;Notogensenoside R1;Gensenoside Rg1;Gensenoside Rb1

Abstract:

Keywords:

基金项目(Foundation): 广东省科技计划项目(2011B031800253)

作者(Author): 廖卫国,朱红霞,刘强,王利胜,余健烨,梁秀清,李周,黄德浩,黄志刚
LIAO Weiguo,ZHU Hongxia,LIU Qiang,WANG Lisheng,YU Jianye,LIANG Xiuqing,LI Zhou,HUANG Dehao,HUANG Zhigang

参考文献(References)：

• [1]罗刚,陈立庭,周晶.中药超微粉碎技术在中药研究中的应用[J].现代药物与临床,2011,26(2):108-112.
• [2]易延逵,刘强,张璐,等.超微粉与普通粉田七痛经胶囊的比较[J].中国实验方剂学杂志2011,17(7):34-36.
• [3]中华人民共和国卫生部药品标准中药成方制剂[S].第十册.1995:38.
• [4]广东省提高中成质量标准起草标准指导原则和技术要求[S].2005:6-10.
• [5]冯毅凡,孟青,梁汉明.田七痛经胶囊质量标准研究[J].中成药,2005,10(27):1146-1149.
• [6]赵严丽,曾奇风.高效液相色谱法测定田七痛经胶囊中原儿茶酸含量[J].中国药业,2013,22(3):11-12.