丹蛇清脂颗粒的质量标准研究  

Study on Quality Standard for Dansheqingzhi Granules

作　　者：李润军 王艳 刘光斌 张玉叶 许开武 李伟龙 LI Run-Jun;WANG Yan;LIU Guang-Bin;ZHANG Yu-Ye;XU Kai-Wu;LI Wei-Long(Department of Pharmacy,Jiayuguan Hospital of Traditional Chinese Medicine of Gansu Province,Jiayuguan 735103,China;Department of Pharmacy,Jiugang Hospital,Jiayugiian 735103,China)

机构地区：[1]甘肃省嘉峪关市中医医院药剂科,甘肃嘉峪关735103 [2]酒钢医院药学部,甘肃嘉峪关735103

出　　处：《中国药物经济学》2021年第11期120-123,128,共5页China Journal of Pharmaceutical Economics

基　　金：嘉峪关市2019年科技计划项目(19-35)。

摘　　要：目的建立丹蛇清脂颗粒的薄层色谱鉴别和含量测定方法,并制定丹蛇清脂颗粒的质量标准。方法采用薄层色谱法对处方中的丹参和白花蛇舌草进行定性鉴别;采用高效液相色谱法测定处方丹参中丹参酮ⅡA的含量。结果薄层色谱鉴别斑点清晰,分离良好,阴性无干扰;丹参酮ⅡA在0.038 94~0.389 44μg范围内呈良好的线性关系(r=0.999 9),平均加样回收率为99.92%,相对标准偏差(RSD)为0.72%(n=9)。结论本研究建立的关于丹蛇清脂颗粒的定性定量方法操作简便,专属性强,结果准确可靠,可有效控制丹蛇清脂颗粒质量。Objective To establish a thin layer chromatography(TLC) identification and content determination method of Dansheqingzhi Granules,and to establish quality standard of Dansheqingzhi Granules.Methods Qualitative identification of Radix Salvia Miltiorrhiza,Herba Hedyotidis in the prescription was conducted by TLC;content determination of Tanshinone ⅡA in Salvia Miltiorrhiza in the prescription was conducted by HPLC.Results The spots in the TLC chromatogram were clear and the degree of separation was good.The negative control showed no interference.The Tanshinone ⅡA had a good linear relationship in the range of 0.03894-0.38944 μg(r=0.9999).The average sample recovery was 99.92% and RSD was 0.72%(n=9).Conclusion The qualitative and quantitative method for Dansheqingzhi Granules established in this study is simple to operate,has strong specificity,the results are accurate and reliable,and can effectively control the quality of Dansheqingzhi Granules.

关 键 词：丹蛇清脂颗粒 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R286.0[医药卫生—中药学]