乳康系列制剂GC指纹图谱建立及化学模式识别  

Establishment of GC Fingerprints and Chemical Pattern Recognition of Rukang Preparations

作　　者：袁航 杨龙华 杨晓云 殷世宁 尹丽华 吴爱英 卢京光 YUAN Hang;YANG Longhua;YANG Xiaoyun;YIN Shining;YIN Lihua;WU Aiying;LU Jingguang(Qingdao Institute for Food and Drug Control/NMPA Key Laboratory for Quality Research and Evaluation of Traditional Marine Chinese Medicine,Qingdao 266071,China)

机构地区：[1]青岛市食品药品检验研究院/国家药品监督管理局海洋中药质量研究与评价重点实验室,山东青岛266071

出　　处：《中国现代中药》2025年第3期437-442,共6页Modern Chinese Medicine

基　　金：中国药品监管科学行动计划第二批重点项目(NMPAJGKX-2023-061)。

摘　　要：目的:建立乳康系列制剂气相色谱法指纹图谱。方法:采用Agilent HP-Innowax色谱柱(30 m×0.32 mm,0.25μm)和氢火焰离子化检测器,以氮气为载气,程序升温模式,建立42批乳康系列制剂的指纹图谱,结合相似度评价、聚类分析(CA)、主成分分析(PCA)和正交偏最小二乘法-判别分析(OPLS-DA),分析乳康系列制剂的质量。结果:确定了29个共有峰,各剂型间的相似度在0.75以上,各剂型内的相似度在0.90以上。CA将42批样品按剂型分为4类,PCA、OPLS-DA结果与CA一致,并筛选出乳康系列制剂的差异性成分共13个峰,其中8号峰指认为莪术酮。结论:建立的方法简便、可靠,可为乳康系列制剂的质量控制提供参考。Objective:To establish gas chromatography(GC)fingerprints for the quality evaluation of Rukang Preparations.Methods:The Agilent HP-Innowax column(30 m×0.32 mm,0.25μm)and flame ionization detector(FID)were used to establish the fingerprints for 42 batches of Rukang Preparations with the temperature programme and N2 as the carrier gas.The similarity evaluation,cluster analysis(CA),principal component analysis(PCA),and orthogonal partial least squares-discriminant analysis(OPLS-DA)were employed to analyze the quality of Rukang Preparations.Results:The GC fingerprints showed 29 common peaks,with the similarity above 0.75 between different preparations and above 0.90 within each preparation.CA classified the 42 batches of samples into 4 classes,which was consistent with the results of PCA and OPLS-DA.A total of 13 peaks indicating the differential components of Rukang Preparations were screened out,among which peak 8 referred to curzerenone.Conclusion:The developed GC fingerprint is simple and reliable and thus can be used for the quality control of Rukang Preparations.

关 键 词：乳康系列制剂 指纹图谱 气相色谱法 化学模式识别 质量评价 

分 类 号：R286[医药卫生—中药学]