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.
作者
钟兰
肖小武
杨甲玺
王兰欣
陈丽楠
付辉政
罗跃华
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)
出处
《中国药学杂志》
CAS
CSCD
北大核心
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)。
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
Fufang Xianzhuli ye
reference drug
quality evaluation
high performance liquid chromatography
fingerprint
chemometrics
content determination
