盐酸溴己新葡萄糖注射液质量标准改进建议  

Exploration and Suggestion on the Specifications of Bromhexine Hydrochloride and Glucose Injection

作　　者：陈乃江 李玲 王婷婷 CHEN Naijiang;LI Ling;WANG Tingting(Lianyungang Institute for Food and Drug Control,Lianyungang,Jiangsu,China 222006)

机构地区：[1]江苏省连云港市食品药品检验检测中心,江苏连云港222006

出　　处：《中国药业》2020年第10期65-68,共4页China Pharmaceuticals

基　　金：江苏省食品药品监督管理局科研项目[20170230]。

摘　　要：目的改进现行盐酸溴己新葡萄糖注射液的质量标准。方法按现行局颁标准YBH10902004-2016Z,YBH04412004-2016Z及《中国药典》(2010年版或2015年版)标准,考察盐酸溴己新葡萄糖注射液可改进的鉴别项、有关物质项、5-羟甲基糠醛(5-HMF)项目检查影响因素及改进方法。结果氯化物鉴别项,3个标准的试验中均无法或难以生成白色沉淀;有关物质项,药品生产企业执行的局颁标准滞后或落后于国家药典,药品有潜在使用风险,且3个标准中的杂质检测不具有可操作性;5-HMF项,3个标准均采用紫外分光光度法,简单便捷、不涉及对照品使用,供试品溶液中盐酸溴己新主药在284 nm波长处有吸收;含量测定项,流动相水相比例<10%时,母液遇高比例有机相甲醇时会出现析晶粘针现象,水相比例超10%时该现象可消失。结论建议取消氯化物鉴别项,修订有关物质中溶剂峰、辅料峰及5-HMF的扣除情况,增订有关物质中已知杂质的液相色谱质谱联用控制方法,保留5-HMF的紫外分光光度法,优化含量测定项的色谱条件。该研究可为盐酸溴己新葡萄糖注射液质量改进提供一定参考。Objective To improve the present specificationsfor bromhexine hydrochloride and glucose injection.Methods The identification,related substances,5-hydroxymethylfurfural(5-HMF)and its content of the product were investigated by referring to the current specifications(YBH10902004-2016 Z,YBH04412004-2016 Z)and standards in Chinese Pharmacopoeia(Edition 2010 or 2005).Results In the three standard tests for chloride identification,no white precipitate was found or was difficult to generate.For the related substance,the standards issued by pharmaceutical companies lagged behind the Chinese Pharmacopoeia,and the drug had potential use risks;impurities in the three standards testswere not operable.For the 5-HMF test,all three standards used UV spectrophotometry,which was simple and convenient,and did not involve the use of reference products;the main drug of bromhexine hydrochloride in the test solution wasabsorbed at 284 nm wavelength.For content determination,when the mobile phase water phase ratio was<10%,the crystallization sticking phenomenon would occur when the liquid was encountered with a high proportion of organic phase methanol,and this phenomenon could disappear when the water phase ratio was 10%.Conclusion It is recommended to cancel the physicochemical identification of chlorination,revise the deduction of solvent peaks,excipient peaks and 5-HMF in related substances,update the LC-MS/MS control method for known impurities in related substances,and retain the UV of 5-HMF spectrophotometry to optimize the chromatographic conditions of the content determination items.This study can provide some reference for the quality improvement of bromhexine hydrochloride and glucoseinjection.

关 键 词：盐酸溴己新葡萄糖注射液 质量标准 质量控制 

分 类 号：R95[医药卫生—药学]