感冒止咳颗粒中柴胡的质量分析研究  

Study on the Quality Analysis of Bupleuri Radix in Ganmao Zhike Granules

作　　者：周鹤 章顺 ZHOU He;ZHANG Shun(Jiujiang Inspection,Testing and Certification Center,Jiujiang Jiangxi 332000,China)

机构地区：[1]九江市检验检测认证中心,江西九江332000

出　　处：《药品评价》2023年第7期834-837,共4页Drug Evaluation

基　　金：九江市科技局计划项目(S2022ZDYFN283)。

摘　　要：目的建立感冒止咳颗粒中柴胡的定性和定量分析方法,以提高其产品质量及质量标准水平。方法柴胡定性鉴别采用薄层色谱法(TLC),硅胶G薄层板,展开剂为醋酸乙酯-乙醇-水(8∶2∶1),显色剂为2%对甲氨基苯甲醛的40%硫酸溶液;采用高效液相色谱法(HPLC)对柴胡皂苷a进行定量检测,色谱柱为Agilent ZORBAX SB-C18,流动相为乙腈-0.1%磷酸溶液(81∶19),ELSD检测器检测。结果柴胡的薄层色谱鉴别方法斑点清晰、专属性强、阴性对照无干扰。柴胡皂苷a进样质量在3.877~11.63μg之间呈良好的线性关系,相关系数为0.9999,检出限为0.007 mg/mL,平均回收率为96.8%,精密度及稳定性良好。结论所建立的柴胡定性和定量分析方法能够有效地控制感冒止咳颗粒的质量,提高其质量标准。Objective The qualitative and quantitative analysis methods of bupleuri radix in ganmao zhike granules were established in order to improve the product quality and quality standard.Methods The qualitative identification of bupleuri radix was performed by thin layer chromatography(TLC),silica gel G thin layer plate,the developing agent was ethyl acethanolethanol-water(8∶2∶1),and the developing agent was 40%sulfuric acid solution of 2%p-methylaminobenzaldehyde.High performance liquid chromatography(HPLC)was used to determine saikosaponin a on Agilent ZORBAX SB-C18 column with mobile phase consisting of acetonitrile-0.1%phosphoric acid solution(81∶19)and ELSD detector.Results The TLC identification method of bupleuri radix had clear spots,strong specificity,and no interference in the negative control.The injection mass of saikosaponin a showed a good linear relationship between 3.877 to 11.63μg,correlation coefficient was 0.9999,detection limit was 0.007 mg/mL,average recovery was 96.8%,and the precision and stability were good.Conclusion The qualitative and quantitative analysis method of bupleuri radix can effectively control the quality of ganmao zhike granules and improve its quality standard.

关 键 词：柴胡属 感冒止咳颗粒 薄层色谱 高效液相色谱 

分 类 号：R286.0[医药卫生—中药学]