输液药包材的急性全身毒性检查法和细胞毒性检查法测试结果的分析与探讨  

Analysis and Discussion on the Results of Acute Systemic Toxicity Test and Cytotoxicity Test for Infusion Pharmaceutical Packaging Materials

作　　者：杨敏 曾涛 黄成超 李烨 张毅兰 YANG Min;ZENG Tao;HUANG Chengchao;LI Ye;ZHANG Yilan(NMPA Key Lab.for Compatibility Studies of Pharmaceutical Products and Packaging Materials,National Advanced Medical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203)

机构地区：[1]中国医药工业研究总院医药先进制造国家工程研究中心,国家药品监督管理局药包材与药物相容性研究重点实验室,上海201203

出　　处：《中国医药工业杂志》2024年第11期1578-1582,共5页Chinese Journal of Pharmaceuticals

摘　　要：急性全身毒性检查法和细胞毒性检查法是输液药包材的常规检测方法。文章总结了该实验室7年来的毒性检测试验,包括急性全身毒性检测有15674批,用小鼠78000余只,未发现不合格检品;细胞毒性检测2627批,有104批不合格。结果显示,经细胞毒性检测不合格的样品,均未表现出急性全身毒性。因此,建议药包材的毒性检查可考虑优先采用细胞毒性检查,既可以减少实验动物的消耗,又能提高检测效率。The acute systemic toxicity test and cytotoxicity test are conventional detection methods for infusion pharmaceutical packaging materials.This study summarized the toxicity detection tests in our lab during the past seven years.There were 15674 batches of acute systemic toxicity tests,using more than 78000 mice,and no unqualified test samples have been found.And 2627 batches of samples underwent the cytotoxicity tests,in which 104 batches were found to be unqualified.The results showed that the samples that failed the cytotoxicity test did not show acute systemic toxicity.Therefore,it is recommended that the cytotoxicity test can be considered as the preferred method for the toxicity test of pharmaceutical packaging materials,which can not only reduce the consumption of laboratory animals but also improve the detection efficiency.

关 键 词：输液 药包材 毒性检测 急性全身毒性检查 细胞毒性检查 

分 类 号：R927.1[医药卫生—药学] TQ460.6*9[化学工程—制药化工]