基于高效液相色谱结合化学计量学方法评价六味地黄浓缩丸质量一致性  

Quality consistency of Liuwei Dihuang concentrated pills was evaluated by high performance liquid chromatography combined with stoichiometry

作　　者：劳永真 章军[1] 刘艳萍 赵桉熠 郭丛[1] 徐凌川[2] 刘安[1] 刘艳[1] LAO Yong-zhen;ZHANG Jun;LIU Yan-ping;ZHAO An-yi;GUO Cong;XU Ling-chuan;LIU An;LIU Yan(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Shandong University of Traditional Chinese Medicine,Jinan 250355,China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]山东中医药大学,济南250355

出　　处：《药物分析杂志》2024年第3期532-541,共10页Chinese Journal of Pharmaceutical Analysis

基　　金：中国中医科学院科技创新工程项目(CI2021A04405)。

摘　　要：目的:建立质量一致性评价方法评价不同厂家间六味地黄浓缩丸质量一致性。方法:首先采用高效液相色谱测定六味地黄浓缩丸中6个指标成分含量,分析同厂家不同批次和不同厂家产品的含量差异;其次构建质量一致性参数即批内含量一致性差异(P_(A))、批间含量一致性差(P_(B))和指纹图谱相似率(P_(C)),以评估不同厂家产品质量均一性;最后以一致性参数为变量,运用主成分分析(PCA)对7个厂家的六味地黄浓缩丸样品的一致性进行拟合与区分。结果:7个厂家的35批次六味地黄浓缩丸样品的6个指标成分含量总计为1.48~2.99 mg·丸^(-1),不同成分含量RSD为4.9%~29.7%,7家产品的P_(A)为4.2%~15.1%,P_(B)为26.4%~49.5%,P_(C)为92.9%~98.2%,不同厂家间样品含量均一性存在一定差异,且产品的批次间含量差异值明显,P为64.5~75.8,表明不同厂家样品一致性差异较小,但在一定条件下,7个厂家样品可划分为三类,B、J为一类,Z、R为一类,X、F、S为一类。结论:本研究提供了一种简单有效的方法用于评估和区分市售六味地黄浓缩丸产品的质量一致性,可为六味地黄浓缩丸生产厂家的样品质量均一性评价提供参考。Objective:To establish a quality consistency assessment method to evaluate the consistency of product quality of Liuwei Dihuang concentrated pills(LDCP)among different manufacturers.Methods:Firstly,high performance liquid chromatography(HPLC)was used to determine the content of the six index components in LDCP,and analyze the content differences between different batches of the same manufacturer and the current product quality of different manufacturers.Secondly,quality consistency parameters,i.e.,intra-batch content consistency differences(P_A),inter-batch content consistency differences(P_(B)),and fingerprint similarity(P_(C)),were constructed to assess the consistency of product quality among the different manufacturers.And lastly,the consistency parameters were taken as the variables and subjected to the principal component analysis(PCA)to classify the consistency of the LDCP samples of the seven manufacturers to be fitted and differentiated.Results:The contents of the six index components in thirty-five batches of LDCP samples from seven manufacturers totaled 1.48-2.99 mg per pill,the RSDs of the contents of different components were 4.9%-29.7%,and the consistency parameters of the seven products were 4.2%-15.1%for P_(A),26.4%-49.5%for P_(B),and 92.9%-98.2%for P_(C).There were some differences in the homogeneity of contents in samples from different manufacturers,and the contents of the product varied significantly between batches,with P value of 64.5-75.8,indicating that the difference in the consistency of samples from different manufacturers was relatively small.But under certain conditions,the seven manufacturers can be classified into three categories,with B and J as a category,Z and R as a category,and X,F,and S as a category.Conclusion:This study provides a simple and effective method for monitoring and distinguishing the quality consistency of commercially available LDCP products,and the experimental results can provide a reference for the sample quality homogeneity of LDCP manufacturers.

关 键 词：六味地黄浓缩丸 质量一致性 批内一致性差异 批间一致性差异 主成分分析 质量分类 

分 类 号：R917[医药卫生—药物分析学]