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新冠疫情期间日本网站上新冠相关药品的流通及其质量和真实性。

Circulation of COVID-19-Related Medicines on Japanese Websites during the COVID-19 Pandemic and Their Quality and Authenticity.

机构信息

Medi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.

Medicine Security Workshop, 4F Venture Business Laboratory, Kanazawa University, Kanazawa, Japan.

出版信息

Am J Trop Med Hyg. 2024 Sep 17;111(5):1097-1106. doi: 10.4269/ajtmh.23-0710. Print 2024 Nov 6.

Abstract

Substandard and falsified medical products for treating COVID-19 have spread worldwide. These medicines have entered Japan through personal importation of products purchased via the Internet. In this study, we investigated the circulation of 19 COVID-19-related medicines on the Internet in Japan and evaluated the pharmaceutical quality and authenticity of 2 medicines (dexamethasone tablets and ivermectin tablets) obtained online. We purchased 23 samples of 0.5-mg dexamethasone tablets and 13 samples of 3-mg ivermectin tablets from the Internet in December 2020 and July 2022. We investigated the quality and authenticity of the obtained samples through visual observation and tested their authenticity. We conducted pharmacopoeia compliance testing (quantitative assay, content uniformity tests, and dissolution tests) using the high-performance liquid chromatography-photodiode array detector method. No prescription was ever required at the time of purchase. Visual observation revealed that most samples lacked a package insert and some samples had packaging deficiencies. In terms of authenticity, eight ivermectin samples were genuine; the authenticity of the other samples remained uncertain. Four dexamethasone samples and three ivermectin samples failed quality testing based on pharmacopeia validation standards. Our findings illustrate that dexamethasone and ivermectin tablets of poor quality are available online. It is important to increase consumer awareness and provide information about these medicines to prevent the purchase of substandard medicines via the Internet.

摘要

用于治疗 COVID-19 的劣质和伪造的医疗产品已在全球范围内传播。这些药品通过个人从互联网购买的产品进口到日本。在这项研究中,我们调查了日本互联网上 19 种与 COVID-19 相关药品的流通情况,并评估了从网上购买的两种药品(地塞米松片和伊维菌素片)的药物质量和真实性。我们于 2020 年 12 月和 2022 年 7 月从互联网上购买了 23 个 0.5 毫克地塞米松片和 13 个 3 毫克伊维菌素片的样本。我们通过视觉观察调查了获得的样本的质量和真实性,并对其真实性进行了测试。我们使用高效液相色谱-光电二极管阵列检测器法进行了药典合规性测试(定量分析、含量均匀度测试和溶出度测试)。在购买时,无需任何处方。视觉观察表明,大多数样本缺乏包装插页,一些样本的包装存在缺陷。在真实性方面,有 8 个伊维菌素样本是真实的;其他样本的真实性仍不确定。根据药典验证标准,有 4 个地塞米松样本和 3 个伊维菌素样本质量检测不合格。我们的研究结果表明,网上有质量较差的地塞米松和伊维菌素片。提高消费者的意识并提供有关这些药品的信息,以防止通过互联网购买劣质药品,这一点非常重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d257/11542516/ff7184821c59/ajtmh.23-0710f1.jpg

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