药用复合膜原料膜及添加物体外细胞毒性研究  

In Vitro Cytotoxicity Study of Medicinal Composite Membrane Materials Membrane and Additives

作　　者：洪燕 游媛 刘宁 龚玮 郑洋滨 HONG Yan;YOU Yuan;LIU Ning;GONG Wei;ZHENG Yangbin(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China.)

机构地区：[1]江西省药品检验检测研究院国家药品监督管理局中成药质量评价重点实验室江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2022年第15期908-911,共4页Drug Evaluation

基　　金：江西省药品监督管理局科研项目(2019JS02)。

摘　　要：目的:比较药用复合膜原料膜、黏合剂添加物及油墨添加物的细胞毒性。方法:以L-929细胞为观察对象,采用MTT法对29种样品的浸提液进行细胞毒性实验,比较毒性等级。结果:29种样品在不同的浸提方法及浸提条件下,表现出对L-929细胞不同的细胞毒性。复合膜原料膜毒性分级在0~1级,黏合剂添加物毒性分级在1~4级,油墨添加物毒性分级在1~4级。结论:药用复合膜的细胞毒性较普遍,为保证临床应用的安全性,减少不良反应的发生,应在其原有标准中增加细胞毒性检查项,为药包材质量的监督管理提供依据。Objective:To compare the cytotoxicity of raw material film,adhesive additives and ink additives of medicinal composite film.Methods:L-929 cells were used as observation object,and MTT method was used to test the cytotoxicity of extracts from 29 samples to compare the toxicity levels.Results:29 samples showed different cytotoxicity to L-929 cells under different extraction methods and conditions.The toxicity classification of composite film raw material film was between 0 and 1,the toxicity classification of adhesive additives was between 1 and 4,and the toxicity classification of ink additives was between 1 and 4.Conclusion:The cytotoxicity of medicinal composite membranes is more common.In order to ensure the safety of clinical application and reduce the occurrence of adverse reactions,the item of cytotoxicity test should be added to the original quality standard,providing reference for the market supervision of clinical application and drug packaging material quality.

关 键 词：药物包装 药物污染 药用复合膜 黏合剂添加物 油墨添加物 细胞毒性检查法 

分 类 号：R965.3[医药卫生—药理学]