一测多评法同时测定六味安消胶囊中5种指标性成分的研究

Determination of 5 Index Components in Liuwei Anxiao Capsules by Quantitative Analysis of Multi-components by Single Marker

目的:建立六味安消胶囊中5种有效成分的一测多评法(QAMS法),探讨一测多评法在六味安消胶囊质量控制中的应用。方法:采用HPLC法,使用Agilent XDB-C_(18)(250 mm×4.6 mm,5μm)色谱柱,流动相为甲醇(A)-0.1%磷酸水溶液(B),梯度洗脱,0~3 min,20%A;3~12 min,20%A→60%A;12~25 min,60%A;25~45 min,60%A→80%A;45~65 min,80%A,体积流量:1.0 ml·min^(-1);检测波长:225、254 nm;柱温:35℃;进样量:20μl。以芦荟大黄素为内参,分别建立木香烃内酯、去氢木香内酯、大黄素和大黄酚相对于芦荟大黄素的相对校正因子,分别采用外标法和一测多评法测定5种成分的量,并比较两者结果的相对误差。结果:建立QAMS法用于测定六味安消胶囊中5种指标性成分的含量,并对5批六味安消胶囊进行测定,其计算值与测定值的差异较小(P>0.05)。结论:QAMS法用于六味安消胶囊中5种指标性成分的含量,方法简单、有效、结果准确,可用于六味安消胶囊的质量控制,并为后续的一测多评法的研究提供参考价值。

Objective： To establish a quantitative analysis of multi-components by single marker（ QAMS） method for the determination of 5 active components in Liuwei Anxiao capsules,and discuss the application of QAMS in the quality control of the product.Methods： An HPLC method was used with an Agilent XDB-C18 column（ 250 mm × 4. 6 mm,5 μm）. The mobile phase was composed of methanol（ A）-0. 1% phosphoric acid solution（ B） with gradient elution（ 0-3 min,20% A; 3-12 min,20% A →60% A; 12-25 min,60% A; 25-45 min,60% A→80% A; 45-65 min,80% A） at the flow rate of 1. 0 ml·min^-1. The detection wavelengths were225 nm and 254 nm,the column temperature was 35℃ and the sample size was 20 μl. Aloe-emodin was selected as the internal standard to establish the relative correction factors（ RCFs） of costunolide,dehydrocostuslactone,emodin and chrysophanol. The contents of the five active components were determined by both external standard method（ ESM） and QAMS. Meanwhile,statistical significance between QAMS and ESM was analyzed to evaluate the QAMS method. Results： The established QAMS was used to determine the 5 index components in Liuwei Anxiao caplsules,and totally 6 batches of Liuwei Anxiao capsules were determined. There were no significant differences in the calculated values and the determined ones（ P〉0. 05）. Conclusion： The QAMS method is simple,effective and accurate in determining the contents of 5 index components in Liuwei Anxiao capsules,which can be used for the quality control of Liuwei Anxiao capsules and provide reference for the further study.