Salim Mohammad Rizalmazli, Widodo Riyanto Teguh, Noordin Mohamed Ibrahim
Department of Pharmaceutical Technology, Faculty of Pharmacy, University Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Malaysia.
Pharmacy Enforcement Division, Ministry of Health, Malaysia, Jln Profesor Diraja Ungku Aziz, 46200 Petaling Jaya, Malaysia.
Polymers (Basel). 2021 Jun 30;13(13):2185. doi: 10.3390/polym13132185.
The detection of counterfeit pharmaceuticals is always a major challenge, but the early detection of counterfeit medicine in a country will reduce the fatal risk among consumers. Technically, fast laboratory testing is vital to develop an effective surveillance and monitoring system of counterfeit medicines. This study proposed the combination of Attenuated Total Reflectance Fourier Transform Infrared (ATR-FTIR) and Differential Scanning Calorimetry (DSC) for the quick detection of counterfeit medicines, through the polymer analysis of blister packaging materials. A sample set containing three sets of original and counterfeit medicine was analyzed using ATR-FTIR and DSC, while the spectra from ATR-FTIR were employed as a fingerprint for the polymer characterization. Intending to analyze the polymeric material of each sample, DSC was set at a heating rate of 10 °C min and within a temperature range of 0- 400 °C, with nitrogen as a purge gas at a flow rate of 20 ml min. The ATR-FTIR spectra revealed the chemical characteristics of the plastic packaging of fake and original medicines. Further analysis of the counterfeit medicine's packaging with DSC exhibited a distinct difference from the original due to the composition of polymers in the packaging material used. Overall, this study confirmed that the rapid analysis of polymeric materials through ATR-FTIR and comparing DSC thermograms of the plastic in their packaging effectively distinguished counterfeit drug products.
假药的检测一直是一项重大挑战，但在一个国家尽早发现假药将降低消费者面临的致命风险。从技术上讲，快速的实验室检测对于建立有效的假药监测系统至关重要。本研究提出将衰减全反射傅里叶变换红外光谱（ATR-FTIR）和差示扫描量热法（DSC）相结合，通过泡罩包装材料的聚合物分析来快速检测假药。使用ATR-FTIR和DSC对包含三组正品和假药的样本集进行分析，同时将ATR-FTIR的光谱用作聚合物表征的指纹图谱。为了分析每个样品的聚合物材料，DSC设定的加热速率为10℃/分钟，温度范围为0至400℃，以氮气作为吹扫气体，流速为20毫升/分钟。ATR-FTIR光谱揭示了假药和正品药品塑料包装的化学特征。由于所使用包装材料中聚合物的组成，用DSC对假药包装进行的进一步分析显示出与正品有明显差异。总体而言，本研究证实，通过ATR-FTIR对聚合物材料进行快速分析并比较其包装中塑料的DSC热谱图能够有效区分假冒药品。
