首页|基于一测多评、化学计量学及灰色关联度分析的脑康泰胶囊质量评价

基于一测多评、化学计量学及灰色关联度分析的脑康泰胶囊质量评价

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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.
Quality Evaluation of Naokangtai Capsules Based on QAMS,Chemometrics,and GRA
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.

Naokangtai CapsulesQAMSMulticomponent quantificationTanshinone ⅡAChemometricsGRAQuality vari-anceComprehensive evaluation

周敏、韩青、李彩凤、孔瑞平、马青修

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江苏食品药品职业技术学院制药工程学院,淮安,223001

中国药科大学药学院,南京,210009

脑康泰胶囊 一测多评法 多组分定量 丹参酮Ⅱ A 化学计量学 灰色关联度分析 质量差异 综合评价

2024

世界中医药
世界中医药学会联合会

世界中医药

CSTPCDCHSSCD北大核心
影响因子:1.266
ISSN:1673-7202
年,卷(期):2024.19(19)