指纹图谱结合聚类分析法研究清热解毒口服液的质量  

Study on the quality of Qingrejiedu Oral Liquid by fingerprint combined with cluster analysis

作　　者：陈柯 陈敏 邹惠亮 CHEN Ke;CHEN Min;ZOU Huiliang(Huzhou Institute for Food and Drug Control,Huzhou 313000,China)

机构地区：[1]湖州市食品药品检验研究院,湖州313000

出　　处：《西北药学杂志》2023年第1期19-25,共7页Northwest Pharmaceutical Journal

基　　金：浙江省2020年药品质量风险考核品种(浙药监通[2020]1号)。

摘　　要：目的建立清热解毒口服液HPLC指纹图谱,结合聚类分析法,为评估清热解毒口服液的质量提供方法,评估投料的合规性。方法用HPLC法,C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈(A)-1 mL·L^(-1)甲酸溶液(B)体系进行梯度洗脱,检测波长为278 nm,流速为1.0 mL·min^(-1),柱温为35℃,用中药色谱指纹图谱相似度评价系统处理数据,并进行聚类分析与主成分分析。结果用该方法对50批制剂进行检测,清热解毒口服液质量存在较大差异,聚类分析结果表明不同地区生产的清热解毒口服液的原料有差异,或者未合规投料。结论该方法可用于评估清热解毒口服液的质量。Objective To establish high-performance liquid chromatography(HPLC)fingerprint of Qingrejiedu Oral Liquid combined with cluster analysis to provide a method for evaluating the quality of Qingrejiedu Oral Liquid and the compliance of the preparation.Methods HPLC was used with C_(18) column(250 mm×4.6 mm,5μm),and acetonitrile(A)-1 mL·L^(-1) formic acid solution(B)system was used for gradient elution.The detection wavelength was 278 nm,the flow rate was 1.0 mL·L^(-1),and the column temperature was 35℃.The data were processed by Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine,and cluster analysis,and principal component analysis were carried out.Results 50 batches of the preparation were detected by this method.There were great differences in quality.The results of cluster analysis showed the raw materials of Qingrejiedu Oral Liquid produced in different regions were different or were not in accordance with the regulations.Conclusion This method can be used to analyze and evaluate the quality of Qingrejiedu Oral Liquid.

关 键 词：清热解毒口服液 指纹图谱 聚类分析 质量评估 

分 类 号：R917[医药卫生—药物分析学]