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首页> 外文期刊>Journal of near infrared spectroscopy >Use of a portable near infrared spectrometer for the authentication of tablets and the detection of counterfeit versions
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Use of a portable near infrared spectrometer for the authentication of tablets and the detection of counterfeit versions

机译：使用便携式近红外光谱仪进行片剂鉴定和仿冒品检测

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Use of a portable near-infrared transmittance spectrometer (NIT-38, NIR Technology, Australia) was evaluated for the authentication of tablets. Operating in the third overtone region (720-1090 nm, 10 nm wavelength increment), the device was used to analyse tablets in transmission mode using a custom-made cell. Authentic tablets of two proprietary products were studied: cialis (n = 14 tablets, from four batches); levitra (n = nine tablets, from three batches). Counterfeit versions of these two products were also analysed: counterfeit cialis (n = 22 tablets, from eight batches); counterfeit levitra (n = 19 tablets, from several batches). Data were converted from transmittance to apparent absorbance and scatter corrected using standard normal variate (SNV) transform. Classification models were constructed for each product from principal component scores and used UNEQ for classification. The classification ability of each UNEQ model was verified using the scores of the other authentic and counterfeit tablets. An unsupervised learning method (Kohonen self-organising map (SOM)) was also studied to further assess the utility of transmission measurements in the third overtone region for identification. Compressed wafers of the active pharmaceutical ingredients (API) and major excipients were prepared and analysed in transmission. These data and those of the analysed tablets were used to train the SOM. UNEQ classification models were able to correctly identify authentic tablets and differentiate them from counterfeits (p< 0.05). The SOM showed close association of authentic tablets with their respective APIs and revealed the presence of several clusters in the counterfeit samples suggesting several sources of origin. Sufficient chemical information was therefore found to exist in the spectra to enable tablet authentication and cluster counterfeits to reveal their likely number of sources of origin.
机译：对便携式近红外透射光谱仪（NIT-38，NIR Technology，澳大利亚）的使用进行了片剂鉴定。在第三个泛音区域（720-1090 nm，10 nm波长增量）中操作，该设备用于使用定制单元以透射模式分析片剂。研究了两种专利产品的真实片剂：西利斯（n = 14片，来自四个批次）;列维特拉（n = 9片，来自三个批次）。还对这两种产品的假冒版本进行了分析：假冒西里斯（n = 22片，来自八批）;假冒艾薇拉（n = 19片，来自多个批次）。将数据从透射率转换为表观吸光度，并使用标准正态变量（SNV）转换校正散射。根据主成分评分为每种产品构建分类模型，并使用UNEQ进行分类。每个UNEQ模型的分类能力均使用其他真假平板电脑的分数进行验证。还研究了一种无监督学习方法（Kohonen自组织图（SOM）），以进一步评估在第三泛音区域进行透射测量以进行识别的效用。制备了活性药物成分（API）和主要赋形剂的压片，并进行了传输分析。这些数据和所分析药片的数据用于训练SOM。 UNEQ分类模型能够正确识别真实的药片并将其与假冒产品区分开（p <0.05）。 SOM显示真实药片与它们各自的API密切相关，并揭示了假冒样品中存在数个簇，表明有多个来源。因此，在光谱中发现了足够的化学信息，可进行片剂鉴定和仿冒品仿冒，以揭示其可能的来源数量。

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