The School of Pharmacy, University of London, 29/39 Brunswick Square, London WC1N 1AX, UK.
Int J Pharm. 2011 Aug 30;415(1-2):102-9. doi: 10.1016/j.ijpharm.2011.05.057. Epub 2011 May 27.
The influx of medicines from different sources into healthcare systems of developing countries presents a challenge to monitor their origin and quality. The absence of a repository of reference samples or spectra prevents the analysis of tablets by direct comparison. A set of paracetamol tablets purchased in Malaysian pharmacies were compared to a similar set of sample purchased in the UK using near-infrared spectroscopy (NIRS). Additional samples of products containing ibuprofen or paracetamol in combination with other actives were added to the study as negative controls. NIR spectra of the samples were acquired and compared by using multivariate modeling and classification algorithms (PCA/SIMCA) and stored in a spectral database. All analysed paracetamol samples contained the purported active ingredient with only 1 out of 20 batches excluded from the 95% confidence interval, while the negative controls were clearly classified as outliers of the set. Although the substandard products were not detected in the purchased sample set, our results indicated variability in the quality of the Malaysian tablets. A database of spectra was created and search methods were evaluated for correct identification of tablets. The approach presented here can be further developed as a method for identifying substandard pharmaceutical products.
来自不同来源的药品涌入发展中国家的医疗体系，对其来源和质量的监测带来了挑战。由于缺乏参考样本或光谱的存储库，无法通过直接比较来分析片剂。使用近红外光谱（NIRS）技术，将在马来西亚药店购买的一组对乙酰氨基酚片剂与在英国购买的类似一组样品进行了比较。还添加了含有布洛芬或对乙酰氨基酚与其他活性剂组合的产品的额外样品作为阴性对照。采集了样品的 NIR 光谱，并通过使用多元建模和分类算法（PCA/SIMCA）进行比较，并存储在光谱数据库中。所有分析的对乙酰氨基酚样品均含有据称的活性成分，只有 1 批样品不在 95%置信区间内，而阴性对照则明显被归类为该组的异常值。虽然在购买的样品集中未检测到劣质产品，但我们的结果表明，马来西亚片剂的质量存在差异。创建了一个光谱数据库，并评估了搜索方法以正确识别片剂。这里提出的方法可以进一步开发，作为识别劣质药品的方法。
