一测多评法同时测定脑栓通胶囊中4种指标成分的含量

Determination of 4 Index Components in Naoshuantong Capsules by Quantitative Analysis of Multi-components by Single Marker

目的:建立一测多评(QAMS)的方法用来测定脑栓通胶囊中4种有效成分的含量。方法:以芍药苷为参照物,采用HPLC法,以Shim-pack GIST C_(18)色谱柱(150 mm×4. 6 mm,5μm);流动相为乙腈(A)-0. 05%磷酸水溶液(B)-四氢呋喃(C)=15∶75∶10;流速:1. 0 ml·min^(-1);检测波长:254 nm;柱温:30℃;进样量:10μl。应用QAMS法的方法测定3个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脑栓通胶囊中的4个指标性成分的含量,并对2种方法计算结果进行对比分析,以验证一测多评法的实用性与稳定性。结果:建立QAMS法可用于测定脑栓通胶囊中4个指标性成分的含量。对6批脑栓通胶囊进行测定,其计算值与测定值比较差异无统计学意义(P> 0. 05)。结论:一测多评法测定脑栓通胶囊中4种成分准确且可行,可用于脑栓通胶囊的质量控制。

Objective: To develop a quantitative analysis method of multi-components by single marker( QAMS) for 4 active constituents in Naoshuantong capsules. Methods: Using paeoniflorin as a reference,an HPLC method with a Shim-pack GIST C18 column(150 mm × 4. 6 mm,5 μm) was applied,the mobile phase was acetonitrile(A)-0. 05% phosphoric acid solution(B)-tetrahydrofuran(C)(15 ∶ 75 ∶ 10). The wavelength was 254 nm,the column temperature was 30℃ and the injection volume was 10 μl. The relative correction factors among the 4 index components were detected by QAMS. The five index contents were determined respectively by an external standard method and QAMS to compare the results obtained from the two different methods and verify the practicability and stability of QAMS. Results: The established QAMS was used to determine the five index components in Naoshuantong capsules,and totally 6 batches of Naoshuantong capsules were determined. There were no significant differences between the calculated values and the determined ones( P > 0. 05). Conclusion: The QAMS method is feasible and accurate in the determination of the 4 chemical compositions,and can be used for the quality control of Naoshuantong capsules.