基于指纹图谱及聚类分析评价小儿咽扁颗粒的质量  

Quality Evaluation of Xiao’er Yanbian Granules Based on Fingerprint and Cluster Analysis

作　　者：姜军华 陈建兰 许妍 吴良发 Jiang Junhua;Chen Jianlan;Xu Yan;Wu Liangfa(Jiangxi Institute for Drug Control,National Medical Products Administration Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Engineering Research Center of Drug and Medical Device Quality of Jiangxi,Nanchang 330029,China;Traditional Chinese Medicine Hospital of Nanchang County,Nanchang 330200,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029 [2]南昌县中医医院,南昌330200

出　　处：《儿科药学杂志》2023年第6期27-31,共5页Journal of Pediatric Pharmacy

基　　金：江西省药品监督管理局科研项目,编号2019JS05。

摘　　要：目的:建立小儿咽扁颗粒高效液相色谱(HPLC)指纹图谱,并结合聚类分析对不同生产企业的小儿咽扁颗粒进行质量评价。方法:基于波长切换技术的HPLC法,色谱柱采用Agilent 5T-C18(2)(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸溶液为流动相梯度洗脱,流速1.0 mL/min,柱温30℃,检测波长280 nm(0~22 min)、327 nm(22~52 min)和280 nm(52~70 min),进样量20μL。采用中药色谱指纹图谱相似度评价系统(2012版)进行相似度评价,同时应用SPSS 24.0统计软件进行聚类分析。结果:小儿咽扁颗粒HPLC指纹图谱中有13个共有峰,指认了11个峰,与对照指纹图谱的相似度为0.947~0.998,表明该品种总体质量稳定。聚类分析结果显示,18批样品可聚为3类。结论:该方法简单、可靠,分离度、重复性良好,可用于小儿咽扁颗粒质量控制。Objective:To establish fingerprints of Xiao’er Yanbian granules by high performance liquid chromatography(HPLC),and to evaluate the quality of Xiao’er Yanbian granules from different production enterprises by cluster analysis.Methods:Based on wavelength switching technology,Agilent 5T-C18(2)column(250 mm×4.6 mm,5μm)was used,the mobile phase was acetonitrile and 0.1%phosphoric acid with gradient elution,flow rate was 1.0 mL/min.The temperature was 30°C,and the detection wavelength was 280 nm(from 0 to 22 min),327 nm(from 22 to 52 min)and 280 nm(from 52 to 70 min)and the sample volume was 20μL.The traditional Chinese medicine chromatographic fingerprint similarity evaluation system software(2012 version)was used to evaluate the similarity,and SPSS 24.0 statistical software was used for cluster analysis.Results:The HPLC fingerprint of Xiao’er Yanbian granules had 13 commons peaks,and 11 of them were identified.The similarity to the control fingerprint profile was from 0.947 to 0.998,indicating that the overall quality of the variety was relatively stable.All 18 batches of samples were clustered into 3 categories.Conclusion:The method is simple,reliable,with good separation and reproducibility,and the fingerprint and cluster analysis results can be used for the quality control.

关 键 词：小儿咽扁颗粒 高效液相色谱法 指纹图谱 聚类分析 

分 类 号：R917[医药卫生—药物分析学]