喜炎平注射液与不同输液器具的相容性研究  

Study on Compatibility of Xiyanping Injection with Different Infusion Devices

作　　者：方礼 刘地发 刘芳芳 刘尧奇 刘明颖 邓双炳 FANG Li;LIU Difa;LIU Fangfang;LIU Yaoqi;LIU Mingying;DENG Shuangbing(State Key Laboratory of Innovative Natural Drugs and TCM Injections,Jiangxi Qingfeng Pharmaceutical Co.,Ltd.,Ganzhou Jiangxi 341000,China;Jinan University,Guangzhou Guangdong 510632,China;Nanjing University of Chinese Medicine,Nanjing Jiangsu 210023,China)

机构地区：[1]创新天然药物与中药注射剂国家重点实验室,江西青峰药业有限公司,江西赣州341000 [2]暨南大学,广东广州510632 [3]南京中医药大学,江苏南京210023

出　　处：《药品评价》2022年第11期659-662,共4页Drug Evaluation

基　　金：中央引导地方科技发展资金项目(S2022KJCXD0014);创新方法工作专项项目(2020IM010500)。

摘　　要：目的:考察喜炎平注射液与不同厂家注射器、输液器相容性,并明确连续输液时需使用的溶媒冲管体积。方法:室温下,按喜炎平注射液最大使用量分别与常用溶媒配伍,考察不同厂家输液器材吸取和输液过程中产品的稳定性,以及使用常用溶媒不同体积冲管后,确认是否有主成分残留。结果:喜炎平注射液使用6种不同厂家、3种不同类型的器材吸取和输液过程中,对产品的性状、pH值、不溶性微粒和含量均无显著影响。冲管溶媒体积大于30 mL时,最大成分含量残留率在0.05%以下。结论:喜炎平注射液使用不同厂家和类型输液器材,相容性良好,但考虑到三件式注射器中橡胶带来的不溶性微粒增加的风险,建议推荐优先使用二件式;喜炎平注射液如需配伍须在不同药物之间进行冲管,冲管体积应不少于30 mL溶媒。Objective:Study on the compatibility of xiyanping injection with different infusion devices,and determine the volume of solvent flushing tube to be used in continuous infusion.Methods:At room temperature,xiyanping injection was mixed with common solvents according to the maximum dosage.The stability of products in the absorption and infusion process of infusion equipment from different manufacturers was investigated,and after using different volumes of common solvents,it was confirmed whether there were component residues.Results:Xiyanping injection had no significant effect on the properties,pH value,insoluble particles and content of the product in the process of absorption and infusion with 6 different manufacturers and 3 different types of equipment.When the volume of flushing solvent was greater than 30 mL,the maximum content residue rate was less than 0.05%.Conclusion:Xiyanping injection has good compatibility with different manufacturers and types of infusion equipment,but considering the risk of increasing insoluble particles caused by rubber in three-piece syringe,it is recommended to give priority to two-piece syringe.If xiyanping injection needs to be used in combination with other injections,it must be flushed between different drugs,and the flushing volume should be no less than 30 mL solvent.

关 键 词：喜炎平注射液 注射器 药用溶液 输液器材 相容性 冲管 

分 类 号：R472[医药卫生—护理学]