小儿化痰止咳颗粒HPLC指纹图谱建立及5种成分含量研究

Establishment of HPLC fingerprint and study on the content five constituents for Xiao′er Huatan Zhike Granules

目的建立小儿化痰止咳颗粒高效液相色谱(HPLC)指纹图谱,同时测定盐酸麻黄碱、桑皮苷A、盐酸吐根酚碱、盐酸吐根碱、吐根苷5种成分的含量,结合化学计量学分析多企业样品的质量差异。方法采用高效液相色谱法和多波长切换,以乙腈-0.4%磷酸溶液为流动相梯度洗脱,流速1.0 mL·min^(-1);柱温35℃;采用相似度、聚类分析和主成分分析进行评价。结果21批次小儿化痰止咳颗粒指纹图谱相似度大于0.897,确定11个共有峰,含量测定中5种成分线性关系良好(r≥0.9990),加样回收率范围为96.68%~101.90%,RSD均小于2%。结论所建立的小儿化痰止咳颗粒指纹图谱和5种成分的含量测定方法可用于其质量控制和质量评价。

Objective To establish the fingerprint of Xiao′er Huatan Zhike Granules,and to determine the contents of ephedrine hydrochloride,mulberroside A,cephaeline dihydrochloride,emetine hydrochloride and ipecacuanhin,the quality difference of samples from multiple enterprises was analyzed by chemometrics.Methods High performance liquid chromatography(HPLC)and multi-wavelength switching detection were used.The mobile phase is acetonitrile-0.4%phosphoric acid solution and flow rate is 1.0 mL·min^(-1).Column oven temperature 35℃;Similarity,cluster analysis and principal component analysis were used for evaluation.Results The similarity of twenty-one batches of Xiao′er Huatan Zhike Granules was greater than 0.897,there were eleven common peaks,and the five indexes showed a good linear relationship(r≥0.9990).The recoveries were 96.68%~101.90%,and the RSD was less than 2%.Conclusion The established infantile phlegm cough particle fingerprint and 5 kinds of index component content determination method can be used for the quality control and quality evaluation.