机构地区:[1]中国药科大学中药学院,江苏南京211198 [2]南京中山制药有限公司江苏省中药经典名方工程技术研究中心,江苏南京210046 [3]江苏弘典中药产业研究院有限公司南京市临床经验方现代化工程研究中心,江苏南京210042
出 处:《海峡药学》2024年第1期36-40,共5页Strait Pharmaceutical Journal
基 金:江苏省知识产权战略推进计划项目(ZT20210180-33)。
摘 要:目的 通过比较浸出物、蚁酸和金属元素含量,系统研究7个产地21批拟黑多刺蚁药材的质量差异,建立一个多元的拟黑多刺蚁药材质量控制体系。方法 按照《中国药典》2020年版测定拟黑多刺蚁浸出物含量;乙醇衍生-顶空气相色谱(GC)法测定拟黑多刺蚁中蚁酸的含量;微波消解-电感耦合等离子体质谱(ICP-MS)法测定拟黑多刺蚁中Mg、Ca、Na、K、Fe、Cu、Zn、Mn、Cr、Co、V、Se 12种元素的含量;采用SPSS结合聚类分析和主成分分析法进行多元统计学分析,评价不同产地拟黑多刺蚁的质量差异。结果 GC测定法显示蚁酸在0.2 mg·mL^(-1)~10 mg·mL^(-1)范围内线性关系良好(R^(2)=1.000),加样回收率为99%~103%;ICP-MS测定法显示12种元素精密度良好(RSD=2.07%~5.09%),重复性良好(RSD=2.58%~7.49%),在各自浓度范围内线性关系良好(R^(2)=0.996~0.999);聚类分析结果显示21批样品可分为3大类:S4~S15、S19和S21聚为一类,S1~S3和S16~S18聚为一类,S20单独为一类;经主成分分析,主成分1、主成分2、主成分3是影响药材品质质量评价的主要因子,3个主成分的累积方差贡献率为91.339%,以S20的主成分综合得分最高,S21的主成分综合得分最低。结论 基于浸出物、蚁酸和金属元素含量,结合聚类分析和主成分分析法进行的多元统计学分析能够评价不同产地拟黑多刺蚁质量,为优质拟黑多刺蚁的产地筛选提供参考。OBJECTIVE By comparing the contents of extracts,formic acid and met al elements,the quality differences of 21 batches of Polyrhachis dives from 7 producing areas were systematically studied,and a multivariate quality control system for Polyrhachis dives was established.METHODS According to the Chinese Pharmacopoeia(2020 edition),the content of the extract of Polyrhachis dives was determined.Ethanol derivation-headspace gas chromatography(GC)was used to determine formic acid in Polyrhachis dives.The contents of Mg,Ca,Na,K,Fe,Cu,Zn,Mn,Cr,Co,V and Se were determined by microwave digestion and inductively coupled plasma mass spectrometry(ICP-MS).Multivariate statistical analysis was carried out by SPSS combined with cluster analysis and principal component analysis to evaluate the quality difference of Polyrhachis dives from different habitats.RESULTS GC assay showed that formic acid had good linear relationship in the range of 0.2 mg·mL^(-1)-10 mg·mL^(-1)(R^(2)=1.000),and the recovery rate was 99%-103%.PQ-MS assay showed good precision(RSD=2.07%-5.09%),good repeatability(RSD=2.58%-7.49%),and good linear relationships(R^(2)=0.996-0.999)in the respective concentration ranges.The cluster analysis results showed that the 21 batches of samples could be divided into three categories:S4-S15、S19、S21;S1-S3、S16-S18;and S20 alone.Principal component analysis showed that principal component 1,principal component 2 and principal component 3 were the main factors affecting the quality evaluation of medicinal materials.The cumulative variance contribution rate of the three principal components was 91.339%,and the principal component comprehensive score of S20 was the highest,while that of S21 was the lowest.CONCLUSION Based on the contents of extractives,formic acid and met al elements,the multivariate statistical analysis combined with cluster analysis and principal component analysis can evaluate the quality of Polyrhachis dives from different habitats,and provide reference for the selection of high-quality Polyrhachis d
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