高效液相色谱指纹图谱结合化学计量学评价上清丸的质量  

Quality evaluation of Shangqing pills by HPLC coupled with chemometrics

作　　者：肖琳婧 秦学玲 龙琴 金蒙 付兴情 张赟华 XIAO Lin-jing;QIN Xue-lin;LONG Qin;JIN Meng;FU Xing-qing;ZHANG Yun-hua(Yunnan Institute for Food and Drug Control,Kunming 650106)

机构地区：[1]云南省食品药品监督检验研究院,昆明650106

出　　处：《中南药学》2023年第8期2163-2169,共7页Central South Pharmacy

基　　金：国家药品抽检项目(No.国药监药管[2022]1号)。

摘　　要：目的建立上清丸HPLC指纹图谱,并结合化学计量学评价其质量。方法利用中药色谱指纹图谱相似度评价系统(2012.130723版)建立上清丸HPLC指纹图谱并进行相似度评价,共标定13个共有峰,通过对照品比对指认11个共有峰。采用主成分分析和偏最小二乘法-判别分析等化学计量学研究方法,对上清丸质量进行评价。结果79批次上清丸(大蜜丸、水蜜丸)与对照制剂相比,相似度均大于0.9,12批次L企业生产的水丸与对照制剂相比,相似度均低于0.7。通过主成分分析对上清丸(大蜜丸、水丸)进行综合评价,大蜜丸综合排名靠前的是A、C、H企业;水丸综合排名靠前的是N、M企业;上清丸(大蜜丸、水丸)大致可以分为2类,结合偏最小二乘法-判别筛选出质量差异标志物,上清丸(大蜜丸)为13(大黄素甲醚)、5(芦荟大黄素)、12(大黄酚)号峰,上清丸(水丸)为3(汉黄芩苷)、1(黄芩苷)号峰。结论该分析方法简单可行,具有良好精密度、重复性和稳定性,建立的指纹图谱可为上清丸的质量评价提供参考。Objective To establish the HPLC fingerprint of Shangqing pills,and evaluate its quality by chemometrics.Methods The fingerprint of Shangqing pills was established by HPLC.Totally 13 common peaks were confirmed and 11 were identified by comparison with the reference substances.Then,the quality of the drug was assessed by principal components analysis(PCA)and partial least squares discriminant analysis(PLS-DA).Results The similarity value of these 79 batches of Shangqing pills was over 0.9,and that of 12 batches from L enterprise was lower than 0.7.Shangqing pills were comprehensively evaluated by PCA.The top companies in the comprehensive ranking of Shangqing big honeyed pills were A,C,and H companies.The comprehensive ranking of Shangqing water pills produced by companies M and N was high.According to the PCA,Shangqing pills(big honeyed pills and water pills)were roughly divided into two categories.Combined with PLS-DA,three common peaks were identified as the quality markers of Shangqing big honeyed pills,which were No.13(physcion),5(aloe-emodin),and 12(chrysophanol).For Shangqing water pills,No.3(wogonin)and 1(baicalin)peaks were identified as the quality markers.Conclusion The analytical method is simple and feasible,with good precision,repeatability and stability.The established fingerprint can provide a reference for the quality evaluation of Shangqing pills.

关 键 词：上清丸 高效液相色谱法 指纹图谱 相似度评价 化学计量学 质量评价 质量差异标志物 

分 类 号：R284.1[医药卫生—中药学]