摘要
目的:建立脑康泰胶囊中羟基红花黄色素A、红花黄色素A、丹参素钠、丹酚酸B、二氢丹参酮Ⅰ、丹参酮Ⅰ、丹参酮ⅡA、洋川芎内酯H、洋川芎内酯Ⅰ、洋川芎内酯A、藁本内酯、莪术二酮和莪术醇的含量测定方法,并结合化学计量学及灰色关联度分析(GRA)对其质量进行综合评价.方法:采用一测多评(QAMS)法,以乙腈-0.1％磷酸为流动相进行梯度洗脱;检测波长分别为403 nm(检测羟基红花黄色素A和红花黄色素A)、280 nm(检测丹参素钠、丹酚酸B、二氢丹参酮Ⅰ、丹参酮Ⅰ、丹参酮ⅡA、洋川芎内酯H、洋川芎内酯Ⅰ、洋川芎内酯A和藁本内酯)和214 nm(检测莪术二酮和莪术醇);结合化学计量学和GRA对多指标成分含量结果进行相关性与差异性分析.结果:方法学验证结果均符合要求;13种成分在各自范围内线性关系良好(r＞0.999 0),平均加样回收率(n=9)在96.92％～100.14％之间(RSD＜2.0％).化学计量学分析显示羟基红花黄色素A、丹酚酸B、丹参酮Ⅱ A、洋川芎内酯A和莪术二酮是影响脑康泰胶囊产品质量的主要潜在标志物.相对关联度在0.350 4～0.638 7之间,生产日期较近生产的脑康泰胶囊质量差异小.结论:QAMS同时测定脑康泰胶囊质量中13种成分,简便实用,化学计量学和GRA可用于评价脑康泰胶囊的整体质量.
Abstract
Objective:To establish a method for determining the content of 13 components in Naokangtai Capsules,including hy-droxy safflor yellow A,safflor yellow A,sodium danshensu,salvianolic acid B,dihydrotanshinone Ⅰ,tanshinone Ⅰ,tanshinone ⅡA,li-gustrazine H,ligustrazine Ⅰ,ligustrazine A,ligustilide,curdione,and curcumol,and to evaluate the overall quality of Naokangtai Capsules using chemometrics and grey relational analysis(GRA).Methods:The quantitative analysis of multiple components(QAMS)was applied,using acetonitrile-0.1％phosphoric acid as the mobile phase for gradient elution.The detection wavelengths were set at 403 nm(for hydroxy safflor yellow A and safflor yellow A),280 nm(for sodium danshensu,salvianolic acid B,dihydro-tanshinone Ⅰ,tanshinone Ⅰ,tanshinone ⅡA,ligustrazine H,ligustrazine Ⅰ,ligustrazine A,and ligustilide),and 214 nm(for curdione and curcumol).Chemometric analysis and GRA were applied to analyze the correlation and differences in the content of the multi-ple components.Results:The method validation results met the required criteria.The 13 components showed good linear relation-ships within their respective ranges(r＞0.999 0),and the average recovery rates(n=9)ranged from 96.92％to 100.14％(RSD＜2.0％).Chemometric analysis revealed that hydroxy safflor yellow A,salvianolic acid B,tanshinone ⅡA,ligustrazine A,and curdione were the key potential markers affecting the quality of Naokangtai Capsules.The relative correlation coefficients ranged from 0.350 4 to 0.638 7,and capsules with more recent production dates showed smaller quality differences.Conclusion:The QAMS method for simultaneously determining the content of 13 components in Naokangtai Capsules is simple and practical.Chemo-metrics and GRA can effectively be used to evaluate the overall quality of the product.
维普
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