茜芷胶囊质量标准提高研究  

Study on Determination Method of Qianzhi Capsules

作　　者：杨博涵[1] 朱旭江 YANG Bohan;ZHU Xujiang(Tianjin Institute of Medical and Pharmaceutical Sciences,Tianjin 300020,China;Gansu Institute for Drug Control,Lanzhou 730070,China)

机构地区：[1]天津市医药科学研究所,天津300020 [2]甘肃省药品检验研究院,甘肃兰州730070

出　　处：《中国民族民间医药》2021年第7期22-26,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

摘　　要：目的:建立茜芷胶囊含量测定和薄层色谱(Thin—Layer Chromatography/TLC)鉴别方法。方法:采用TLC法对处方中川牛膝进行定性鉴别;采用高效液相色谱(High Performance Liquid Chromatography/HPLC)法,以CAPCELL PAK C18(4.6 mm×250 mm,5μm)色谱柱分离,流动相为乙腈-水(50∶50),检测波长300 nm,流速1.0 m L·min^(-1),柱温30℃。测定欧前胡素、异欧前胡素含量。结果:TLC鉴别有较强的专属性,阴性对照无干扰;欧前胡素在0.0276~0.4409μg范围内呈良好的线性关系,r=0.9999,加样回收率为99.97%,RSD为1.66%;异欧前胡素在0.0168~0.2680μg范围内呈良好的线性关系,r=0.9999,加样回收率为99.66%,RSD为1.15%。结论:该方法专属性强、重现性好,可以控制本品的质量。Objective To set up the quality standard of Qianzhi capsules and TLC identification.Methods Qualitative identification of Cyathula officinalis Kuan in prescription by TLC;The content of imperatorin and isoimperatorin were determined by HPLC.The chromatographic condition was as follows:Waters Acquity BEH C18 column(4.6 mm×250 mm,5μm),using mobile phase with acetonitrile-water(50∶50),the detective wavelength was set at 300 nm,with a flow rate of 1.0 L/min and the column temperature was30℃.Results TLC identification has strong specificity,negative control without interference;HPLC determined that imperatorin was in range from 0.0276 to 0.4409μg,which presented a good linear relationship(r=0.9999).The average recovery was 99.97%,RSD was 1.66%.HPLC determined that isoimperatorin was in range from 0.0168 to 0.2680μg,which presented a good linear relationship(r=0.9999).The average recovery was 99.66%,RSD was 1.15%.Conclusion The method is specific and reproducible.It can control the quality of Qianzhi capsules.

关 键 词：茜芷胶囊 TLC HPLC 欧前胡素 异欧前胡素 

分 类 号：R284.1[医药卫生—中药学]