药学与临床研究2024,Vol.32Issue(4) :324-328.

不同厂家牛黄解毒片中24种无机元素ICP-MS检测与质量评价

Study on 24 Inorganic Elements in Niuhuang Jiedu Tablets from Different Manufacturers Based on ICP-MS and Statistical Analysis Differences for Quality Evaluation

李佳 熊金龙 张艳 卜媛媛 陈广云 陈小红
药学与临床研究2024,Vol.32Issue(4) :324-328.

不同厂家牛黄解毒片中24种无机元素ICP-MS检测与质量评价

Study on 24 Inorganic Elements in Niuhuang Jiedu Tablets from Different Manufacturers Based on ICP-MS and Statistical Analysis Differences for Quality Evaluation

李佳 1熊金龙 1张艳 1卜媛媛 1陈广云 1陈小红1
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作者信息

  • 1. 江苏省淮安市食品药品检验所,淮安 223300
  • 折叠

摘要

目的:建立牛黄解毒片中无机元素指纹图谱,结合化学计量学探究不同厂家产品中无机元素差异,评价他们质量的均一性.方法:对全国21个生产企业的牛黄解毒片,采用微波消解后-ICP-MS法测定样品中K、Mn、Zn等24种无机元素的含量,绘制无机元素质量分数分布图,通过主成分分析法对质量均一性进行评价.结果:24种元素ICP-MS测定在各自范围内线性关系均良好(r≥0.9996),回收率在86.9%~112.2%之间(RSD≤1.6%).建立了牛黄解毒片无机元素指纹图谱,从指纹图谱相似度及PCA结果看,牛黄解毒片中无机元素的质量均一性较好,主要特征元素为K、Mn、Zn、B、Ni、Al、V、Cr、Ba、Sn.结论:本研究建立的无机元素指纹图谱可为牛黄解毒片质量评价提供研究基础.

Abstract

Objective:To establish fingerprints of inorganic elements in Niuhuang Jiedu Tabletss,explore their differences from different manufacturers with chemometrics,and evaluate their quality uniformity.Methods:An ICP-MS method after microwave digestion was employed for the determination of the con-tents of 24 inorganic elements including K,Mn and Zn in Niuhuang Jiedu tablets from 21 production en-terprises nationwide.A distribution map of inorganic element mass fraction was drawn and the quality uni-formity was evaluated through principal component analysis.Results:The linear calibrations were estab-lished for the ICP-MS determination of the 24 elements(with r≥0.999),and the recoveries were 86.9%-112.2%(RSD≤1.6%).The fingerprints of inorganic elements in Niuhuang Jiedu tablets were established.From the similarity of the fingerprints and PCA results,the quality uniformity of inorganic elements in Ni-uhuang Jiedu tablets was confirmed,with the main characteristic elements being K,Mn,Zn,B,Ni,Al,V,Cr,Ba and Sn.Conclusion:The inorganic element fingerprints established at the same time can provide a research basis for the quality evaluation of Niuhuang Jiedu tablets.

关键词

牛黄解毒片/无机元素/ICP-MS/指纹图谱/质量均一性/主成分分析

Key words

Niuhuang Jiedu Tablets/Inorganic elements/ICP-MS/Fingerprint/Quality uniformity/principal component analysis

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基金项目

江苏省市场监督管理局科技计划项目(KJ2022085)

出版年

2024
药学与临床研究
江苏省药学会

药学与临床研究

CSTPCD
影响因子:0.95
ISSN:1673-7806
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