牛黄清感胶囊HPLC特征指纹图谱研究及多成分含量测定

Study on Fingerprint and Multi-components Determination of Niuhuang Qinggan Capsules by HPLC

目的建立牛黄清感胶囊HPLC指纹图谱,并测定其中7种有效成分的含量。方法采用HPLC,色谱柱为Agilent SB-C18(250 mm×4.6 mm,5μm),以乙腈(A)-0.1%磷酸水溶液(B)为流动相进行梯度洗脱;检测波长210 nm;柱温30℃。采用"中药色谱指纹图谱相似度评价系统(2004A版)"进行相似度分析,并对指认的7个指标成分进行定量测定研究。结果在特征图谱研究中,共确定牛黄清感胶囊HPLC指纹图谱22个共有峰,通过与对照品比较指认其中7个共有峰分别为绿原酸、咖啡酸、木犀草苷、黄芩苷、黄芩素、汉黄芩苷和汉黄芩素,利用相似度软件对12批样品指纹图谱进行分析,各批样品相似度均>0.90。定量分析条件通过方法学验证,平均加样回收率为99.1%~104.8%,RSD为1.30%~1.88%。结论所建立的HPLC指纹图谱和含量测定分析方法可用于牛黄清感胶囊质量控制。

OBJECTIVE To establish the HPLC fingerprint and determine the contents of seven compounds in Niuhuang Qinggan capsules simultaneously.METHODS The separation was carried out on an Agilent SB-C18 column(250 mm×4.6 mm,5μm).The mobile phase was acetonitrile(A)-0.1%acetic acid solution(B)with gradient elution,the detection wavelength was 210 nm,and column temperature was 30℃."Similarity evaluation system for chromatographic fingerprint of TCM(2004 A)"was used to conduct,and the seven markers were quantified.RESULTS The common mode of the fingerprint showed 22 common peaks,7 of which were identified by comparison with the reference substances.They were chlorogenic acid,caffeic acid,luteolin-7-o-glucoside,baicalin,baicalein,wogonoside and wogonin.The similar degrees of 12 batches of samples were>0.90,and the average recoveries varied from 99.1%-104.8%with RSDs of 1.30%-1.88%.CONCLUSION The established method can be used for the quality control of Niuhuang Qinggan capsules.