止痢宁片指纹图谱研究及4种成分定量分析

HPLC fingerprints and quantitative analysis of four components in Zhilining tablets

目的建立止痢宁片高效液相色谱(HPLC)指纹图谱及同时测定4种成分含量的方法。方法利用HPLC法建立止痢宁片指纹图谱,并采用化学计量模型筛选质量差异标志物,同时测定4种成分的含量。结果19批样品的指纹图谱中有13个共有峰,相似度>0.900,样品聚为3类,找出5个质量差异标志物;苦参碱、穿心莲内酯、脱水穿心莲内酯、木香烃内酯4种成分在各自范围内线性关系良好(r>0.9990);平均加样回收率95.0%~100.0%,相对标准偏差(RSD)<2.0%。结论该方法准确可靠,为止痢宁片全面质量控制提供参考。

Objective To establish the HPLC fingerprints for Zhilining tablets,and to determine four com-ponents in tandem.Methods HPLC method was used to establish the fingerprint of Zhilining tablets,and the chemical stoichiometry model was used to screen the quality difference markers,while determining the content of four components.Results There were 13 common peaks in the fingerprint of 19 samples,with a similarity was more than 0.900.The samples were grouped into three categories,and five quality difference markers were identi-fied.The linear relationship of matrine,andrographolide,dehydroandrographolide and costunolide was good within their respective ranges(r>0.9990).The average sample recovery rate was 95.0%to 100.0%,with the RSD was less than 2.0%.Conclusion This method is accurate and reliable,providing a reference for the comprehensive quality control of Zhilining tablets.