用于冷链运输中温度监测的时间温度指示剂的研究进展

A Review of Time-temperature Indicators for Temperature Monitoring in Cold Chain Transportation

温度时间指示剂(又称温敏标签)可记录在冷链运输、仓储或终端使用阶段的温度变化轨迹,适于作为药品的智能包装。温敏标签通过颜色变化,直观地将温度变化轨迹转换成清晰的视觉信息。例如,采用10,12-二十五碳二炔酸材料制成的温敏标签上的指示剂在初始状态(0℃)呈蓝色,温度升高时随着时间的推移,逐渐显红色并沿着毛细纤维轨迹向另一端扩散。因而,使用者可通过该视觉信息辨识得知药品是否经历过不适宜的温度,继而判断药品的货架寿命及质量安全是否受到影响。温敏标签根据用途可分为临界温度温敏标签(critical temperature indicator,CTI)、临界温度或时间温敏标签(critical temperature/time indicator,CTTI)和时间温度温敏标签(time-temperature indicator,TTI);其中TTI又分为可逆与不可逆标签,根据工作原理还可分为扩散型、聚合反应型和生物酶分解型。但TTI价格较高,在国内的普及度并不高,并且研究也较少。本文根据工作原理分类综述了不可逆型TTI的研究进展,并展望其在药学领域的未来发展趋势。

Temperature-time indicators(also known as the temperature-sensitive labels)can record the temperature change trajectory during the cold chain transportation,storage,and usage of pharmaceutical products,which are suitable for intelligent packaging of medicines.Temperature-sensitive labels intuitively convert the temperature change trajectory into clear visual information through color changes.For indeed,the temperature-time indicator containing 10,12-pentacosadiynoic acid is blue in initial state(0℃).While temperature increases,the indicator slides to the other end along the capillary fiber and its color gradually changes to red.Therefore,people can recognize whether the medicine has experienced an inappropriate temperature through the visual information,then judge whether the shelf life and quality safety of the medicine are affected.Temperature-sensitive labels can be divided into critical temperature indicators(CTI),critical temperature/time indicators(CTTI)and time-temperature indicators(TTI).Among them,TTI can be divided into reversible and irreversible types.According to the working principle,TTI can also be divided into diffusionbased,polymerization-based and biological enzyme-catalyzed degradation-based types.However,the expensive price of TTI makes low popularity in domestic,and there are only a few related researches.This paper summarizes the research progress of irreversible TTI with different working principles and prospects the future development in the pharmaceutical field as well.