参七心疏胶囊中6种指标性成分的一测多评法研究  

Research on the One Test Multiple Evaluation Method for Six Indicator Components in Shenqi Xinshu Capsules

作　　者：李艳花 陈睿彦 马邦喜 赵声婷 赵泽娟 LI Yanhua;CHEN Ruiyan;MA Bangxi;ZHAO Shengting;ZHAO Zejuan(Zhaotong Inspection and Testing Institute,Zhaotong,Yunnan 657000,China)

机构地区：[1]昭通市检验检测院,云南昭通657000

出　　处：《药学与临床研究》2025年第1期54-57,共4页Pharmaceutical and Clinical Research

摘　　要：目的:建立参七心疏胶囊中6个成分(阿魏酸、葛根素、甘草苷、丹参酮ⅡA、丹酚酸B、丹参素钠)含量的HPLC一测多评方法(QAMS法)。方法:采用高效液相色谱法,JADE-PAK R KM-C18(4.6 mm×150 mm,5μm),以甲醇-乙腈(1∶1)和0.1%磷酸水溶液为流动相梯度洗脱,流速1.0 mL·min^(-1),检测波长270、321 nm,柱温30℃。以葛根素为内参物,建立与其他5个成分的相对校正因子,并计算6个待测成分的含量,实现一测多评。同时与外标法进行比较,以验证一测多评含量测定方法的准确性和可行性。结果:在一定的线性范围内,阿魏酸、甘草苷、丹参酮ⅡA、丹酚酸B、丹参素钠的相对校正因子值分别为5.88、1.52、1.53、5.66、0.44(相对校正因子RSD<2.0%),并与外标法进行比较,发现两者含量间无统计学差异。结论:以葛根素为内参物,建立参七心疏胶囊中6个成分的一测多评含量测定方法准确、可行,可用于参七心疏胶囊的定量分析及质量控制。Objective:To establish an HPLC method for simultaneous determination of six components in Shenqixinshu capsules(QAMS method).Methods:A Jade-Pak RKM-C18 column was used for high per-formance liquid chromatography,the mobile phase was methanol-acetonitrile(1∶1)and 0.1%phosphoric acid solution for gradient elution.The flow rate was 1.0 mL·min^(-1),the detection wavelength was 270 nm and 321 nm,and the column temperature was 30℃.Using puerarin as internal reference,the relative cor-rection factors with the other five components were established,and the contents of the five components to be tested were calculated,so as to realize one test and multiple evaluations.At the same time,it is compared with the external standard method to verify the accuracy and feasibility of the QAMS method.Results:Within a certain linear range,the relative correction factor values of ferulic acid,glycyrrhizin,tanshinoneⅡA,salvianolic acid B,and danshensu sodium were 5.88,1.52,1.53,5.66,and 0.44,respec-tively(relative correction factor RSD<2.0%),and compared with the external standard method,no statisti-cal difference was found between the two methods.Conclusion:Using puerarin as internal reference,the QAMS method for assaying the six components in Shenqi Xinshu capsules is accurate and feasible,and can be used for quantitative analysis and quality control of Shenqi Xinshu Capsules.

关 键 词：参七心疏胶囊 一测多评法 葛根素 

分 类 号：R927.2[医药卫生—药学]