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  

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

作　　者：周敏[1] 韩青 李彩凤 孔瑞平 马青修 ZHOU Min;HAN Qing;LI Caifeng;KONG Ruiping;MA Qingxiu(School of Pharmaceutical Engineering,Jiangsu Food&Pharmaceutical Science College,Huai′an 223001,China;School of Pharmacy,China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]江苏食品药品职业技术学院制药工程学院,淮安223001 [2]中国药科大学药学院,南京210009

出　　处：《世界中医药》2024年第19期2889-2896,2907,共9页World Chinese Medicine

基　　金：国家自然科学基金青年科学基金项目(21503087);江苏省高等学校基础科学(自然科学)研究重大项目(23KJA350001)。

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>0.9990),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ⅡA、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0.3504~0.6387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。Objective:To establish a method for determining the content of 13 components in Naokangtai Capsules,including hydroxy safflor yellow A,safflor yellow A,sodium danshensu,salvianolic acid B,dihydrotanshinone I,tanshinone I,tanshinoneⅡA,ligustrazine 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,dihydrotanshinone I,tanshinone I,tanshinoneⅡA,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 multiple components.Results:The method validation results met the required criteria.The 13 components showed good linear relationships within their respective ranges(r>0.9990),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,tanshinoneⅡA,ligustrazine A,and curdione were the key potential markers affecting the quality of Naokangtai Capsules.The relative correlation coefficients ranged from 0.3504 to 0.6387,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.Chemometrics and GRA can effectively be used to evaluate the overall quality of the product.

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

分 类 号：R284.1[医药卫生—中药学]