盐酸溴己新葡萄糖注射液的5-羟甲基糠醛检查方法研究  

Study on the determination of 5-hydroxymethylfurfural in bromhexine hydrochloride and glucose injection

作　　者：刘毅[1] 吴建敏[1] 姚晓 刘晓强 李选堂 林兰[1] 何兰[1] LIU Yi;WU Jian-min;YAO Xiao;LIU Xiao-qiang;LI Xuan-tang;LIN Lan;HE Lan(National Institutes for Food and Drug Control,Beijing 102629,China;Changzhou Institute for Drug Control,Changzhou 213002,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]江苏省常州市药品检验所,常州213002

出　　处：《中国新药杂志》2018年第22期2612-2615,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项资助项目(2015ZX09303001);中国食品药品检定研究院学科带头人培养基金资助项目(2015X3)

摘　　要：目的:对盐酸溴己新葡萄糖注射液标准的5-羟甲基糠醛检查方法进行研究,为其标准统一工作提供有力的参考数据。方法:UV方法(溶剂:水,检测波长284 nm)和RP-HPLC方法:色谱柱:ZORBAX Extend-C18柱(150 mm×4. 6 mm,5μm);流动相:0. 1%磷酸-甲醇(85∶15);流速为1.0 mL·min^(-1);柱温30℃;检测波长284 nm。结果:2种方法线性好、重现性好且差异较小,均可作为5-羟甲基糠醛的质量控制方法;但UV法更简单、方便、快速,检测灵敏度完全可以达到制剂中5-羟甲基糠醛限度控制的要求(0. 02%),而且无需5-羟甲基糠醛对照品。结论:UV法仍是广大基层药品检验单位较为理想的盐酸溴己新葡萄糖注射液中5-羟甲基糠醛检查方法。Objective: To study the determination of 5-hydroxymethylfurfural in bromhexine hydrochloride and glucose injection,and provide solid reference data for harmonization of drug standards. Methods: UV method and HPLC method were applied. For the UV method,water was used as solvent and the detection wavelength was set at 284 nm. For the RP-HPLC method,the separation was performed on a ZORBAX Extend-C18 column with the mobile phase composed of methanol-aqueous solution containing 0. 1% phosphoric acid(15∶ 85),and the isocratic elution flow rate was 1.0 mL·min^(-1). The column temperature was 30 ℃ and the detection wavelength was set at284 nm. Results: Both UV and HPLC methods had good linearity,reproducibility and small variation,and could be used as the quality control method for 5-hydroxymethylfurfural. However,the UV method which completely met the demand of limit-control for 5-hydroxymethylfurfural(0. 02%),was simpler and faster than the HPLC method,and it did not need chemical reference substance. Conclusion: The UV method is preferred for the determination of5-hydroxymethylfurfural in bromhexine hydrochloride and glucose injection to the vast grass-roots institutes for drug control.

关 键 词：盐酸溴己新葡萄糖注射液 5-羟甲基糠醛检查 紫外分光光度法 反相高效液相色谱法 质量控制 

分 类 号：R917[医药卫生—药物分析学]