摘要
稳定的生物学性质是人血白蛋白等生物制品发挥正常临床生理功效以及避免或降低不良反应的重要保证,温度是影响其生物学性质的一个重要因素。目前,人血白蛋白等生物制品运输全过程温度记录以及产品的电子溯源体系这两方面信息化水平还处于起步阶段,不能实现全链条无缝温度监控。本研究以人血白蛋白为实例,建立了基于温控IOT云平台的冷链追溯系统并进行应用,可为生物制品的全过程冷链监管追溯以及医药冷链行业发展提供参考。
Stable biological properties are an important guarantee for human blood albumin and other biological products to play a normal clinical physiological effect and avoid or reduce adverse reactions,and temperature is an important factor affecting their biological properties.At present,the informatization level of temperature recording in the whole process of transportation of biological products such as human blood albumin and electronic traceability system of products is still in its infancy,and seamless temperature monitoring of the whole chain cannot be achieved.This paper takes human blood albumin as an example to establish the research and application of cold chain traceability system based on temperature control IOT cloud platform,which can provide reference for the whole process of cold chain supervision and traceability of biological products and the development of pharmaceutical cold chain industry.
作者
刘绪平
肖小武
陈文强
陈秀良
易路遥
LIU Xuping;XIAO Xiaowu;CHEN Wenqiang;CHEN Xiuliang;YI Luyao(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;Jiangxi Provincial Drug Certification&Evaluation Center,Nanchang Jiangxi 330006,China;Jiangxi Guoke Meixin Medical Technology Co.,Ltd,Fuzhou Jiangxi 344099,China;Boya Bio-Pharmaceutical Group Co.,Ltd,Fuzhou Jiangxi 344100,China)
出处
《药品评价》
CAS
2024年第8期911-914,共4页
Drug Evaluation
基金
江西省重点研发项目(20212BBG73024)。
关键词
人血白蛋白
生物制品
温控IOT云平台
冷链监管追溯系统
Human blood albumin
Biological products
Temperature control IOT cloud platform
Cold chain supervision traceability system
