HPLC法同时测定益气养血口服液中6种防腐剂含量  

Simultaneous Determination of Six Preservatives in Yiqi Yangxue Oral Liquid by HPLC

作　　者：李霞 杨鑫 易徐航 杨恢检 肖小武 LI Xia;YANG Xin;YI Xuhang;YANG Huijian;XIAO Xiaowu(Pingxiang Institute for Food and Drug Control,Pingxiang 337000,China;Jiangxi Provincial Institute for Drug Control/NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine,Nanchang 330000,China)

机构地区：[1]江西省萍乡市食品药品检验所,江西萍乡337000 [2]江西省药品检验检测研究院/国家药品监督管理局中成药质量评价重点实验室,江西南昌330000

出　　处：《中国民族民间医药》2025年第8期59-64,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：国家药品监督管理局中成药质量评价重点实验室开放课题(JXKL-2023-02)。

摘　　要：目的:建立HPLC法同时测定益气养血口服液中苯甲酸、山梨酸钾、羟苯甲酯、羟苯乙酯、羟苯丙酯、羟苯丁酯6种防腐剂的含量。方法:采用Agilent 5TC-C_(18)(250 mm×4.6 mm,5μm)色谱柱:以甲醇-0.01 mol/L乙酸铵溶液为流动相,梯度洗脱,流速为1.0 mL/min;检测波长为230 nm(0~11 min,苯甲酸);256 nm(11~40 min,山梨酸钾、羟苯酯类);进样量为10μL,柱温为25℃。结果:6种防腐剂在各自线性范围内线性关系良好(r≥0.9998);平均加样回收率分别为99.9%~104.3%,RSD分别为0.53%~1.40%(n=6)。结论:本法简便、灵敏,重现性好,可用于益气养血口服液的防腐剂的限量测定。Objective To establish an HPLC method for the simultaneous content determination of benzoic acid,potassium sorbate,methyl p-hydroxybenzoate,ethyl p-hydroxybenzoate,propyl p-hydroxybenzoate,butyl p-hydroxybenzoate in Yiqi Yangxue Oral Liquid.Methods The chromatographic separation was performed on an Agilent 5TC-C_(18)column(250 mm×4.6 mm,5μm)column with Methanol-0.01mol/L ammonium acetate acid solution as the mobile phase(gradient elution).The flow rate was 1 mL·min^(-1)and the detection wavelengths were set at 230 nm for benzoic acid,256 nm for potassium sorbate,methyl p-hydroxybenzoate,ethyl p-hydroxybenzoate,propyl p-hydroxybenzoate,butyl p-hydroxybenzoate.the injection volume wad 110μL,the Column temperature was set at 25℃.Results Six preservatives showed good linear relationship within their own ranges(r≥0.9995),whose average recoveries were 99.9%-104.3%with the RSDs of 0.53%-1.40%(n=6).Conclusion The method was stable,sensitive and reproducible,which can be used for the determination of preservatives of Yiqi Yangxue Oral Liquid.

关 键 词：益气养血口服液 防腐剂 含量测定 HPLC 

分 类 号：R284[医药卫生—中药学]