陈通
CHEN Tong

• 1:上海华源药业(宁夏)沙赛制药有限公司

摘要(Abstract)：

目的 研究盐酸氨溴索注射液的不同配伍溶液与输液器具间的安全相容性，为盐酸氨溴索注射液在临床输注使用时，对输注器具的选择提供理论依据。方法 根据盐酸氨溴索注射液性质，选择体积分数15%乙醇溶液、pH 3.0缓冲液、pH 10.0缓冲液作为模拟提取溶剂，对聚氯乙烯(polyvingl chloride, PVC)材质输注器具进行模拟提取试验，初步确定目标元素杂质和有机浸出物质。在迁移实验中，对目标浸出物质实际迁移量进行准确测定，最终评价其对人体安全的影响。结果 PVC材质输液器与盐酸氨溴索注射液的质量分数0.9%氯化钠配伍溶液、林格氏配伍溶液接触22 h,及与盐酸氨溴索注射液的质量分数5%葡萄糖配伍溶液接触，元素杂质和有机物浸出风险极低。结论 PVC材质输液器与盐酸氨溴索注射液各配伍溶液相容性良好，在临床输注使用时，可采用该类材质输液器按药品说明书进行输注，安全性较高。
Objective To study the compatibility of ambroxol hydrochloride injection with infusion apparatus, and to provide basis for the selection of infusion apparatus for ambroxol hydrochloride injection.Methods According to the properties of Ambroxol hydrochloride injection solution, 15% ethanol solution, pH3.0 buffer and pH10.0 buffer were selected as the simulated extraction solvent, under the more severe conditions, the simulated extraction test of the polyvinyl chloride infusion apparatus was carried out, and the target element impurities and organic leach substances were preliminarily determined.In the migration experiment, the actual migration amount of the target lixivium is measured accurately, and its safety effect on human body is evaluated finally.Results The PVC infusion set was exposed to 0.9% sodium chloride solution of ambroxol hydrochloride injection, Ringe′s solution for 22 h, and 5% glucose solution of ambroxol hydrochloride injection for 22 hours, the leaching risk of elemental impurities and organic compounds is extremely low.Conclusion The compatibility of PVC material infusion set and Ambroxol hydrochloride injection is good.It is safe to use this kind of material infusion set according to the drug instruction.

关键词(KeyWords)： 盐酸氨溴索注射液;给药器具相容性;一次性输液器
ambroxol hydrochloride injection;compatibility of administration apparatus;disposable infusion set

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 陈通
CHEN Tong

DOI: 10.14066/j.cnki.cn21-1349/r.2021.0932

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