基于对照制剂的复方鲜竹沥液指纹图谱和多组分含量测定研究  

Fingerprint and Multi-Component Determination of Fufang Xianzhuli ye Based on Reference Drugs

作　　者：钟兰 肖小武 杨甲玺 王兰欣 陈丽楠 付辉政 罗跃华[1,2] ZHONG Lan;XIAO Xiao-wu;YANG Jia-xi;WANG Lan-xin;CHEN Li-nan;FU Hui-zheng;LUO Yue-hua(School of Pharmacy,Nanchang University,Nanchang 330019,China;Jiangxi Provincial Institute for Drug Control,NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Nanchang 330029,China)

机构地区：[1]南昌大学药学院,南昌330019 [2]江西省药品检验检测研究院,国家药监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

出　　处：《中国药学杂志》2023年第2期178-187,共10页Chinese Pharmaceutical Journal

基　　金：江西省重点研发项目资助(20203BBG73062);江西省药品监督管理局科研项目资助(2020JS04)。

摘　　要：目的以对照制剂为随行对照,对6个厂家28批复方鲜竹沥液质量进行评价。方法采用高效液相色谱法(HPLC)建立复方鲜竹沥液指纹图谱,并测定原儿茶酸、糠酸、对羟基苯甲酸、2,6-二甲氧基苯酚、水杨酸、(+)-南烛木树脂酚-3α-O-β-D-吡喃葡萄糖苷的含量;以对照制剂作为随行对照,并结合聚类分析(CA)和正交-偏最小二乘法判别分析(OPLS-DA),对样品质量进行评价。结果标定了复方鲜竹沥液指纹图谱的16个共有峰,指认了13个成分;6个厂家28批样品中,只有9批样品与对照制剂的相似度大于0.75。含量测定结果显示,28批样品均未检测到2,6-二甲氧基苯酚,2~4批样品的原儿茶酸、糠酸、对羟基苯甲酸含量与对照制剂相应含量的比值大于60%,1批样品的水杨酸含量与对照制剂相应含量比值大于50%,15批样品的(+)-南烛木树脂酚-3α-O-β-D-吡喃葡萄糖苷含量与对照制剂对应含量比值大于80%,复方鲜竹沥液整体质量不稳定;CA分析将对照制剂和F厂家样品聚为一类,B厂家样品聚为一类,其他4个厂家样品聚为一类;OPLS-DA分析筛选出(+)-南烛木树脂酚-3α-O-β-D-吡喃葡萄糖苷、原儿茶酸等6个差异性成分。结论所建方法简便、准确,可用于复方鲜竹沥液的质量控制与评价。OBJECTIVE To assess the quality of 28 batches of Fufang Xianzhuli ye from 6 manufacturers with reference drugs as the accompanying control.METHODS HPLC was used to establish the fingerprint of Fufang Xianzhuli ye,and to determine the contents of protocatechuic acid,furoic acid,p-hydroxybenzoic acid,2,6-dimethoxyphenol,salicylic acid and(+)-lyonirenisol-3α-O-β-D-glucopyranoside.The quality of samples was evaluated using reference drugs as accompanying control,as well as cluster analysis and orthogonal partial least squares-discriminant analysis.RESULTS The fingerprints of Fufang Xianzhuli ye contained 16 common peaks,and thirteen components were identified.The similarity between 9 samples and reference drugs was above 0.75 among 28 samples from 6 manufactures.The results of the content determination revealed that 2,6-dimethoxyphenol was not detected in any of the 28 batches of samples.The content of protocatechuic acid,furoic acid,and p-hydroxybenzoic acid in 2 to 4 samples was greater than 60%of that in reference drugs,the content of salicylic acid in 1 Xsample was greater than 50%of that in reference drugs,and the content of(+)-lyonirenisol-3α-O-β-D-glucopyranoside in 15 samples was greater than 80%of that in reference drugs.These results indicated that the overall quality of Fufang Xianzhuli ye was poor.Though cluster analysis,reference drugs and samples from manufacturer F were clustered into groupⅠ,the samples from manufacturer B were clustered into groupⅡ,and the samples from the other four manufacturers were clustered into groupⅢ.Based on the orthogonal partial least squares method-discriminant analysis,6 components with large differences,such as(+)-lyonirenisol-3α-O-β-D-glucopyranoside and protocatechuic acid,were screened out.CONCLUSION The established method is simple and accurate,and it can be used for Fufang Xianzhuli ye quality control and evaluation.

关 键 词：复方鲜竹沥液 对照制剂 质量评价 高效液相色谱法 指纹图谱 化学计量学 含量测定 

分 类 号：R284[医药卫生—中药学]