不同流通渠道制何首乌饮片质量评价OA
Quality Evaluation of Polygoni Multiflori Radix Praeparata Decoction Pieces from Different Distribution Channels
目的 综合评价不同流通渠道制何首乌饮片的质量.方法 收集 27 批样品,包括连锁零售药店 12 批,3 个不同的中药饮片生产企业 15 批,并按 2025 年版《中国药典(一部)》制何首乌项下的检测方法,测定总灰分、醇溶性浸出物、二苯乙烯苷和游离蒽醌(包括大黄素、大黄素甲醚)的含量,进行主成分分析(PCA)和偏最小二乘-判别分析(PLS-DA),并以层次聚类分析(HCA)进行验证.结果 二苯乙烯苷、大黄素、大黄素甲醚质量浓度分别在 23.96~575.04µg/mL、21.48~214.76µg/mL、8.36~83.56µg/mL范围内与峰面积线性关系良好(r=1.000 0,n=6);精密度、稳定性、重复性试验结果的 RSD均小于 2.0%;平均加样回收率分别为100.95%,96.56%,100.26%,RSD分别为 0.94%,0.58%,1.27%(n=6).不同流通渠道的样品呈显著的质量差异,HCA、PCA和PLS-DA结果显示,27 批样品可聚为 2 类,醇溶性浸出物和游离蒽醌是区分不同流通渠道饮片的标志物.结论 建立的方法操作简便,灵敏度、精密度、重复性良好,联合化学计量法,可用于制何首乌饮片的质量控制.
Objective To comprehensively evaluate the quality of Polygoni Multiflori Radix Praeparata decoction pieces from different distribution channels.Methods A total of 27 batches of samples were collected,including 12 batches from chain retail pharmacies and 15 batches from three different Chinese herbal medicine decoction piece manufacturers.According to the testing methods specified in the 2025 edition of Chinese Pharmacopoeia(Volume Ⅰ)for Polygoni Multiflori Radix Praeparata,the contents of total ash,alcohol-soluble extractives,stilbene glycoside,and free anthraquinones(including emodin and physcion)were determined.Principal component analysis(PCA)and partial least squares-discriminant analysis(PLS-DA)were performed,and hierarchical cluster analysis(HCA)was used for validation.Results The linear ranges of stilbene glycoside,emodin,and physcion were 23.96-575.04 µg/mL,21.48-214.76 µg/mL,and 8.36-83.56 µg/mL,respectively(r=1.000 0,n=6).The RSDs for precision,stability,and repeatability test results were all lower than 2.0%.The average recoveries were 100.96%,96.56%,and 100.26%,with RSDs of 0.94%,0.58%,and 1.27%,respectively(n=6).Significant quality differences were observed among samples from different distribution channels.HCA,PCA,and PLS-DA results showed that the 27 batches of samples could be clustered into two categories,and alcohol-soluble extractives and free anthraquinones were the key quality markers distinguishing decoction pieces from different distribution channels.Conclusion The established method is simple,sensitive,and reproducible.Combide with chemometrics,it can be used for the quality control of Polygoni Multiflori Radix Praeparata decoction pieces.
赖飞娥;秦永洁;李婷婷;陈燕青;覃乾汉;江鸳;刘喜华;赵应学
广西卫生职业技术学院药学院,广西 南宁 530021广西壮族自治区江滨医院,广西 南宁 530021广西壮族自治区江滨医院,广西 南宁 530021广西壮族自治区江滨医院,广西 南宁 530021广西壮族自治区药品监督管理局,广西 南宁 530029培力<南宁>药业有限公司,广西 南宁 530007广西卫生职业技术学院药学院,广西 南宁 530021广西壮族自治区江滨医院,广西 南宁 530021
医药卫生
制何首乌化学计量学质量评价流通渠道
Polygoni Multiflori Radix Praeparatachemometricsquality evaluationdistribution channel
《中国药业》 2026 (16)
76-83,8
广西壮族自治区卫生和计划生育委员会自筹经费科研课题[Z20180828]广西壮族自治区药品监督管理局项目[GXZC2018-C3-20716-XYGC].
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