Drug Management and Policy, Kanazawa University, Kanazawa, Japan.
Department of Pharmacy, University of Asia Pacific, Dhaka, Bangladesh.
Trop Med Int Health. 2018 Mar;23(3):263-269. doi: 10.1111/tmi.13028. Epub 2018 Jan 21.
To evaluate the quality of omeprazole personally imported into Japan via the Internet and to compare the quality of these samples with previously collected samples from two other Asian countries.
The samples were evaluated by observation, authenticity investigation and pharmacopoeial quality analysis. Quality comparison of some selected samples was carried out by dissolution profiling, Raman spectroscopy and principle component analysis (PCA).
Observation of the Internet sites and samples revealed some discrepancies including the delivery of a wrong sample and the selling of omeprazole without a prescription, although it is a prescription medicine. Among the 28 samples analysed, all passed the identification test, 26 (93%) passed the quantity and content uniformity tests and all passed the dissolution test. Dissolution profiling confirmed that all the personally imported omeprazole samples remained intact in the acid medium. On the other hand, six samples from two of the same manufacturers, previously collected during surveys in Cambodia and Myanmar, frequently showed premature omeprazole release in acid. Raman spectroscopy and PCA showed significant variation between omeprazole formulations in personally imported samples and the samples from Cambodia and Myanmar.
Our results indicate that the pharmaceutical quality of omeprazole purchased through the Internet was sufficient, as determined by pharmacopeial tests. However, omeprazole formulations distributed in different market segments by the same manufacturers were of diverse quality. Measures are needed to ensure consistent quality of products and to prevent entry of substandard products into the legitimate supply chain.
评估通过互联网个人从日本带入的奥美拉唑的质量，并将这些样品与之前从另外两个亚洲国家收集的样品的质量进行比较。
通过观察、真实性调查和药典质量分析对样品进行评估。对一些选定的样品进行了质量比较，包括溶出度分析、拉曼光谱和主成分分析（PCA）。
观察网站和样品发现了一些差异，包括交付错误的样品和未经处方销售奥美拉唑，尽管它是一种处方药。在分析的 28 个样品中，所有样品均通过了鉴别试验，26 个（93%）通过了含量和含量均匀度试验，所有样品均通过了溶出度试验。溶出度分析证实，所有个人进口的奥美拉唑样品在酸性介质中均保持完整。另一方面，在柬埔寨和缅甸的调查中收集的来自两个相同制造商的六个样品，在酸性条件下经常出现奥美拉唑过早释放。拉曼光谱和 PCA 表明，个人进口样品和来自柬埔寨和缅甸的样品之间的奥美拉唑制剂存在显著差异。
我们的结果表明，通过药典测试，通过互联网购买的奥美拉唑的药物质量是足够的。然而，同一制造商在不同市场领域销售的奥美拉唑制剂质量存在差异。需要采取措施确保产品质量的一致性，并防止不合格产品进入合法供应链。
