梨杷止咳合剂质量标准研究

目的建立梨杷止咳合剂的质量标准。方法采用薄层色谱(TLC)法对制剂中桑白皮、苦杏仁、枇杷叶进行定性鉴别;采用高效液相色谱法测定木犀草苷、3,5-双咖啡酰基奎宁酸的含量,色谱柱为Phenomenex R Luna C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.5%冰醋酸溶液(15∶85,V/V),流速为1.0 m L/min,检测波长为350 nm,柱温为30℃,进样量为10μL。结果桑白皮、苦杏仁、枇杷叶的TLC图斑点清晰,分离度好,阴性对照无干扰。木犀草苷、3,5-双咖啡酰基奎宁酸进样量分别在0.0801~1.6014μg和0.0371~0.7418μg范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于3.5%;平均加样回收率分别为100.80%和97.73%,RSD分别为3.12%和3.83%(n=6)。结论该方法操作简便,结果准确,可用于梨杷止咳合剂的质量控制。

Quality Standard of Lipa Zhike Mixture

Objective To establish the quality standard of Lipa Zhike Mixture.Methods Thin-layer chromatography(TLC)was adopted for the qualitative identification of Cortex Mori,Semen Armeniacae Amarum and Folium Eriobotrya Japonica in Lipa Zhike Mixture.High-performance liquid chromatography(HPLC)was adopted for the content determination of luteolin and 3,5-dicaffeoylquinic acid,the chromatographic column was Phenomenex R Luna C18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.5%glacial acetic acid solution(15∶85,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 350 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The TLC spots of Cortex Mori,Semen Armeniacae Amarum and Folium Eriobotrya Japonica were clear and well separated without negative interference.The linear ranges of luteolin and 3,5-dicaffeoylquinic acid were 0.0801-1.6014μg and 0.0371-0.7418μg,respectively.The RSDs of precision,stability and repeatability tests were less than 3.5%.The average recoveries of luteolin and 3,5-dicaffeoylquinic acid were 100.80%and 97.73%with RSDs of 3.12%and 3.83%(n=6),respectively.Conclusion The method is simple and accurate,which can be used for the quality control of Lipa Zhike Mixture.