一测多评法同时测定心可宁胶囊中5种指标性成分的研究  

Determination of Five Index Components in Xinkening Capsules by Quantitative Analysis of Multi-components by Single Marker

作　　者：陆瑶 李秀明 LuYao;Li Xiuming(Chuzhou Institute for Food and Drug Control, Anhui Chuzhou 239000, Chin)

机构地区：[1]滁州市食品药品检验中心,安徽滁州239000

出　　处：《中国药师》2018年第4期743-746,共4页China Pharmacist

摘　　要：目的:建立一测多评(QAMS)法来测定心可宁胶囊中5种指标性成分的含量。方法:采用HPLC法,以Agilent XDBC18柱(250 mm×4.6 mm,5μm)为色谱柱,流动相为乙腈-0.05%磷酸水溶液,梯度洗脱,流速1.0 ml·min^(-1),检测波长210nm,柱温30℃。以丹酚酸B为内参物建立5种指标性成分之间的相对校正因子,分别采用外标法和一测多评法测定心可宁胶囊中5种指标性成分的含量,并对两种方法测定结果进行对比分析,以验证一测多评法的实用性与稳定性。结果:一测多评法的计算值与外标法测定值间差异无统计学意义(P>0.05),试验所得校正因子可信。结论:所建立的QAMS法可用于测定心可宁胶囊中5种指标性成分的含量。Objective： To develop a determination method of quantitative analysis of multi-components by single marker （QAMS） for five index components in Xinkening capsules. Methods： An HPLC method was applied with an Agilent XDB-C18 column （250 mm × 4.6 mm,5 μm）, the mobile phase was acetonitrile-0.05% phosphoric acid with gradient elution at the flow rate of 1.0 ml·min -1, the detection wavelength was 210 nm and the column temperature was 30%. With salvianolic acid B as the internal standard, the relative correction factors among the five index components were established. The five index components were determined by an external standard method and QAMS, respectively. The results of the two methods were compared to confirm the practicality and stability of QAMS. Results： There were no significant differences between the calculated values in QAMS and the estimated values in the external standard method （ P 〉 0.05 ）, and the relative correction factors were credible. Conclusion： The established QAMS method can be used for determining the contents of the five index components in Xinkening capsules.

关 键 词：一测多评法 心可宁胶囊 丹参素钠 原儿茶醛 人参皂苷Rg_1 丹酚酸B 丹参酮ⅡA 

分 类 号：R927.2[医药卫生—药学]