参麦注射液中糖类成分含量测定研究

目的建立测定参麦注射液中4种糖类成分的反相高效液相色谱法。方法采用Prevail Carbohydrate ES色谱柱(4.6 mm×250 mm,5μm),以乙腈-水(79∶21)为流动相,流速1.0 mL.min-1;ELSD漂移管温度100℃,氮气流速2.8 L.min-1测定果糖、葡萄糖、蔗糖和麦芽糖含量。结果果糖、葡萄糖、蔗糖和麦芽糖分别在0.763 2～15.26 40μg、0.626 8～12.536 0μg、0.860 4～17.208 0μg、0.754 4～15.088 0μg范围内呈良好的对数线性关系。平均回收率分别为99.05%、100.38%、98.75%、99.52%,RSD为1.5%、1.3%、1.7%、1.1%。结论该方法简便、准确、重复性好,可作为参麦注射液的质量控制方法。

Study on determination of carbohydrate in Shenmai Injection

Objective To establish a RP -HPLC method for determination of four kinds of carbohydrate in Shenmai Injection. Methods Prevail Carbohydrate ES （ 4.6 mm × 250 mm, 5 μm ） column was adopted with acetonitrile - water （ 79： 21 ） as mobile phase,and the flow rate was 1.0 mL · min-l. ELSD was used to qualitatively determine fructose, glucose, sucrose and maltose, with the drift temperature of 100 ℃ and N： flow rate of 2.8 L · min - 1. Result The linear range of fructose, glucose, sucrose and maltose were respectively 0.763 2- 15. 264 0 μg,0.626 8 - 12.536 0 μg,0.860 4 - 17. 208 0 μg,0.754 4 - 15. 088 0 μg,with corresponding average recovery rate of 99.05%, 100.38% ,98.75% ,99.52% and the RSD was 1. 5%, 1. 3%, 1. 7%, 1.1%, respectively. Conclusion The method was simple, accurate and reproducible and can be used for the quality control of Shenmai Injection.