柴芩清肾颗粒质量标准的研究

Study on quality standard of Chai Qin Qing Shen Ke Li

目的:建立柴芩清肾颗粒的定性、定量鉴别方法。方法:采用薄层色谱法对柴芩清肾颗粒中的黄芩、金银花、柴胡、连翘进行定性鉴别。采用高效液相色谱法测定制剂中黄芩苷的含量,色谱柱:ZorbaxC18柱(4.6mm×250mm,5μm);流动相:甲醇-水-冰醋酸(50∶50∶1);流速:1.0mL/min;检测波长:277nm;进样量:10μL。结果:采用薄层色谱法定性鉴别专属性强,斑点清晰;含量测定结果表明,黄芩苷的线性范围为0.202μg～4.04μg,r=0.9999(n=5),平均加样回收率为100.22%,RSD=1.53%(n=6)。结论:所建立的方法简便、准确,专属性强,可作为柴芩清肾颗粒的质量控制标准。

Objective：To establish the qualitative and quantitative detective method of Chai Qin Qing Shen Ke Li （CQQSKL）. Methods：Thin layer chromatography（TLC）was adopted to determine the contents of Radix Seutellariae,Flos Lonicerae Japonicae,Radix Bupleuri,and Fructus Forsythiae in CQQSKL,and high performance liquid chromatography （HPLC）was for the content of baicalin. Zorbax C18 column （4.6 mm×250 mm,5 μm）was used,the mobile phase was methanol-water-glacial acetic acid （50：50：1）,the flow rate 1.0 ml/min,the detection wavelength 277 nm,and the sample size 10 μL. Results：TLC presented strong specificity and distinct spots. The outcomes of content determined showed that the linear range of baicalin was 0.202-4.（M μg,r=0.9999 （n=5）,the mean recovery was 100.22%,RSD=1.53% （n=6）. Conclusion：The method established is simple, accurate and strong in specificity and it can be adopted for the quality control of Chai Qin Qing Shen Ke Li.