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通络滴丸的质量控制研究
引用本文:李广胜,韩永成.通络滴丸的质量控制研究[J].中国医院药学杂志,2015,35(6):503-506.
作者姓名:李广胜  韩永成
作者单位:1. 河南中医学院第三附属医院, 河南 郑州 450008; 2. 恩华药物研究院, 江苏 徐州 221100
基金项目:河南省教育厅自然科学研究计划项目(编号:2010A360016)
摘    要:目的:建立通络滴丸的质量控制方法.方法:采用薄层色谱法(TLC)鉴别成方制剂中石斛、金银花、牛膝,以高效液相色谱(HPLC)法测定毛兰素和绿原酸的含量.结果:TLC法可明显鉴别石斛、金银花、牛膝.毛兰素在4.4~66.0 μg·ml-1内线性关系良好,r=0.999 9,加样平均回收率为93.89%,RSD为2.37%;绿原酸在36.0~540.0 μg·ml-1内线性关系良好,r=0.999 7,加样平均回收率为94.17%,RSD为1.99%.结论:该方法操作简便,结果准确,重复性好,可用于该制剂的质量控制.

关 键 词:高效液相色谱法  毛兰素  通络滴丸  薄层色谱  质量控制  
收稿时间:2014-07-22

Study on quality control on Tongluo pills
LI Guang-sheng;HAN Yong-cheng.Study on quality control on Tongluo pills[J].Chinese Journal of Hospital Pharmacy,2015,35(6):503-506.
Authors:LI Guang-sheng;HAN Yong-cheng
Institution:1. Third Affiliated Hospital of Henan College of Traditional Chinese Medicine, Henan Zhengzhou 450008, China; 2. Nhwa Institute of Pharmaceutical Research, Jiangsu Xuzhou 221100, China
Abstract:OBJECTIVE To establish the quality control standards for Tongluo pills.METHODS Dendrobium nobile,Lonicera Japonica and Achyranthes bidentata Bl were identified by TLC.Scoparone and chlorogenic acid were determined by HPLC.RESULTS The results of TLC showed that the relevant spots were clear without interference in the blank reference. Good linear relationships between the peak area and contents of scoparone and chlorogenic acid were achieved when the dose was within 4.4-66.0 μg·ml-1,36.0-540.0 μ g·ml-1.The recovery rates were 93.89% and 94.17%.RSDs were 2.37% and 1.99%,respectively (n=6). CONCLUSION The established qualitative and quantitative methods are simple,accurate,reliable and reproducible, and can be effectively used for quality control of anti-inflammative pills.
Keywords:HPLC  scoparone  chlorogenic acid  Tongluo pills  TLC  quality control  
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