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利用动态热分析区分真假药物。

The use of dynamic thermal analysis to distinguish between genuine and counterfeit drugs.

机构信息

School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia in Katowice, Department of Basic Biomedical Science, Kasztanowa Street 3, Sosnowiec 41-200, Poland.

出版信息

Int J Pharm. 2015 Jul 25;490(1-2):16-21. doi: 10.1016/j.ijpharm.2015.04.077. Epub 2015 May 12.

DOI:10.1016/j.ijpharm.2015.04.077
PMID:25975231
Abstract

WHO estimates that 10% of drugs are falsified. Economic and health factors arising from the use of counterfeit drugs lead to the development of new methods for distinguishing genuine medicines from falsified ones. The purpose of this study was to develop a new, fast, and inexpensive method to distinguish between original and fake drugs. 10 counterfeit Viagra(®) tablets were compared to 4 original pills (Pfizer). The drugs - both original and fake - were heated to 60°C and then the dynamics of their temperature changes at ambient conditions was tested using a thermal imaging camera. The time constants τ showing the dynamics of temperature changes for Viagra(®) and the falsified drug were determined. The thermokinetic parameters of drugs were determined in the temperature range of 60-22.2°C. Both original and counterfeit tablets had different time constants: 171.44 ± 4.62s and 182.71 ± 4.05 s, respectively. Differences in the dynamics of temperature changes as a function of time are particularly pronounced in the range of t+2 to t+7 min. The comparison of the time constants τ enables to distinguish between genuine and counterfeit drugs. The proposed new method which uses dynamic thermal analysis is an effective, cheap and fast technique to distinguish genuine drugs from counterfeit ones.

摘要

世卫组织估计,10%的药品是伪造的。使用假药带来的经济和健康因素促使人们开发出区分真假药品的新方法。本研究旨在开发一种新的、快速且廉价的方法来区分原药和假药。将 10 片伪造的 Viagra(®) 片剂与 4 片原药(辉瑞公司)进行比较。将这些药品——包括原药和假药——加热至 60°C,然后使用热成像摄像机测试其在环境条件下温度变化的动力学。确定显示 Viagra(®) 和伪造药物温度变化动力学的时间常数 τ。在 60-22.2°C 的温度范围内确定了药物的热动力学参数。原药和假药的时间常数分别为 171.44 ± 4.62s 和 182.71 ± 4.05 s。在 t+2 到 t+7 分钟的时间范围内,温度变化动力学的差异尤其明显。时间常数 τ 的比较可用于区分真假药物。该研究提出的新方法使用动态热分析,是一种有效、廉价且快速的技术,可用于区分真假药物。

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