基于一测多评法对注射用益气复脉(冻干)中糖类成分的质量控制研究

目的 建立一测多评法（QAMS）测定注射用益气复脉（冻干）（YQFM）中4种糖类成分含量的分析方法，并探讨在蒸发光散射检测器（ELSD）上建立QAMS分析法的可行性。方法 采用HPLC-ELSD技术，以果糖对照品为内参物，建立其与葡萄糖、蔗糖、麦芽糖的相对校正因子（f），通过f计算YQFM中3种糖类成分；并在25批YQFM中进行验证，同时将该方法与外标两点法测定的结果进行对比分析，以验证QAMS法的适用性、可行性和重复性。结果 在一定的线性范围内，YQFM中4种糖类成分间的相对校正因子分别为：f_葡/果＝0.743，f_蔗/果＝0.823，f_麦/果＝0.695。QAMS法的计算结果与外标两点法的实测值之间存在显著性差异，其相对偏差远远大于5%。结论 HPLC-ELSD外标法能够准确地测定YQFM中4种糖类成分的含量，而在ELSD检测器上建立的QAMS法准确度不如外标法，其原理与适用范围需要更进一步的探究。

Quality control for Carbohydrates of Yiqi Fumai Lyophilized Injection based on quantitative analysis of multi-components with a single-marker

Objective To establish a quantitative analysis of multi-components with a single-marker (QAMS) method for the determination of four components in Yiqi Fumai Lyophilized Injection (YQFM) and the feasibility of establishing QAMS methods on ELSD was further explored. Methods Fructose was used as the internal reference substance. The relative correlation factors (f) of glucose, sucrose and maltose were calculated and established. The results were compared with those obtained by the external standard method in 25 batches of YQFM. Results Within the linear ranges, the f values of glucose, sucrose and maltose to fructose were 0.743, 0.823, 0.695. The two methods show the significant difference in assay results. Conclusion HPLC-ELSD can precisely determine contents of four carbohydrates in YQFM; meanwhile, the accuracy of QAMS method built on ELSD was inferior to that of external standard method, and the working principle of ELSD and feasible concentration range remain to be further studied.