利胆排石糖浆质量标准研究

Study on Quality Standard of Lidan Paishi Syrup

目的:增加质量控制内容以提升利胆排石糖浆的质量标准。方法:基于原质量标准,采用薄层色谱法,增加人工牛黄、枳壳的定性鉴别方法。采用高效液相色谱法对利胆排石糖浆中绿原酸的含量加以测定。结果:人工牛黄和枳壳的薄层色谱图中,均出现清晰且无阴性干扰的斑点。在浓度为8.196μg/mL~409.8μg/mL的范围内,绿原酸的含量测定显示良好的线性关系(r=0.9999),平均回收率为105.6%(RSD=1.53%)。结论:所建立的方法专属性强、重复性好,可用于利胆排石糖浆的质量控制。

Objective:Add new quality controls for lidan paishi syrup to improve its quality standard.Methods:Based on the previous quality standard,TLC was adopted in the qualitative identification of bovis calculus artifactus,aurantii fructus.Using high performance liquid chromatography(HPLC)to determine chlorogenic acid in lidan paishi syrup.Results:Bovis calculus artifactus and aurantii fructuswere observed the clear TLC spots without negative interference.And at the ranges from 8.196μg/mL to 409.8μg/mL,the chlorogenic acid showed good linear relationship(r=0.9999).The average recovery was 105.6%(RSD=1.53%).Conclusions:The established methods are exclusive and repeatable,which can be used for the quality control of lidan paishi syrup.