在也门亚丁对选定的授权药品和走私药品进行质量比较研究

E. Ali, Olfat Saleh Ahmed, Hala Shokri
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引用次数: 0

摘要

在也门,大部分药物都是进口的。通过合法途径进入该国的药品要经过药品和医疗器械最高委员会(SBDMA)的一些检测,以评估产品的质量。然而,一些药物非法进入该国(走私),这使得它们绕过了SBDMA对其质量的评估。进行这项工作是为了确定在亚丁药店销售的授权和走私药品的物理质量控制参数。选取亚丁药店销售的头孢呋辛(CEF)、阿托伐他汀(ATR)和卡维地洛(CAR)片剂的授权品牌和走私品牌。对所制片剂进行了物理性能评价和质量控制参数的测定,包括重量变化、硬度、脆性和崩解试验。用紫外光谱法测定了药物含量。实物鉴定结果显示,同一产品的授权品牌和走私品牌除注册号和生产日期只在授权品牌上出现外,在形状、颜色、包装和标签信息等方面基本一致。CEF、ATR、CAR三个授权和走私品牌,除ATR的硬度值外,重量版本、直径、厚度和硬度、脆性、崩解等测试均符合官方规范。所有授权品牌都与标签上的声明一致,而一些走私品牌含有适当的有效成分,但含量不正确。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A COMPARATIVE QUALITY STUDY OF SELECTED AUTHORIZED AND SMUGGLED MEDICINES IN ADEN, YEMEN
In Yemen, most of the medicines are imported. Drugs that enter the country by legal means undergo some tests by Supreme Board for Drugs and Medical Appliances (SBDMA) to evaluate the quality of the product. However, some medicines enter the country illegally (smuggling) and this makes them bypass the evaluation of their quality by the SBDMA. This work was carried out to determine the physical quality control parameters of authorized and smuggled drug products marketed in Aden pharmacies. The authorized and smuggled brands of cefuroxime (CEF), atorvastatin (ATR), and carvedilol (CAR) tablets available in Aden pharmacies were selected. The tablets were evaluated for their physical properties and quality control parameters including weight variation, hardness, friability, and disintegration test. The level of drug content also was evaluated using UV spectroscopy. The physical assessment showed that the authorized and smuggled brands of the same products were uniform in shape, color, packing, and labeling information except for the registration number and manufacture date which were present only on the authorized brands. The three authorized and smuggled brands of CEF, ATR, and CAR complied with the official specifications for weight version, diameter, thickness and hardness, friability, and disintegration tests except for the hardness value of ATR. All authorized brands agreed with the label claims whereas some smuggled brands contained the appropriate active ingredients but did not contain the right amounts.
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