Human and Veterinary Medicines, Tanzania Medicines and Medical Devices Authority (TMDA), Dar es Salaam, Tanzania.
Pharmaceutical and Medicinal Chemistry, Institute for Pharmacy and Food Chemistry, Universität Würzburg, 97074 Würzburg, Germany.
J Antimicrob Chemother. 2024 Jul 1;79(7):1619-1627. doi: 10.1093/jac/dkae155.
The quality of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets was evaluated to determine whether there is any difference in quality when comparing the country of origin. This was undertaken because it has been claimed that antibiotics manufactured in Europe are of superior quality to those originating from Africa or Asia.
Samples of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets were collected from three randomly selected wholesale pharmacies in each city, namely Arusha, Dar es Salaam and Mwanza, Tanzania. The collected samples of collected brands were subjected to quality control testing as per their respective pharmacopoeial monographs. Amoxil 250 mg capsules (Glaxo Wellcome, Mayenne, France), Rocephin (Roche, Switzerland) and Cipro-Denk 500 (Allphamed Pharbil Arzneimittel GmbH, Gottingen, Germany) were used as reference brands for the other generic brands of amoxicillin, ceftriaxone and ciprofloxacin, respectively.
A total of 31 brands (10 different brands of amoxicillin capsules, 9 of ceftriaxone sodium injections, and 12 of ciprofloxacin tablets) were collected from the targeted regions and subjected to quality control testing. All samples of collected brands complied with the requirements of their respective pharmacopoeial monographs.
There was no significant difference in quality between brands of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets manufactured in Africa and Asia against those manufactured in Europe in terms of compliance with the respective pharmacopoeial monographs.
评估阿莫西林胶囊、头孢曲松注射剂和环丙沙星片的质量，以确定比较原产国时质量是否存在差异。之所以这样做，是因为有人声称欧洲生产的抗生素质量优于非洲或亚洲生产的抗生素。
从坦桑尼亚的阿鲁沙、达累斯萨拉姆和姆万扎三个随机选择的批发药店各采集一批阿莫西林胶囊、头孢曲松注射剂和环丙沙星片的样本。按照各自的药典专论对采集的品牌样本进行质量控制测试。将 Amoxil 250mg 胶囊（法国 Glaxo Wellcome，马耶讷）、罗氏芬（瑞士罗氏）和 Cipro-Denk 500（德国 Allphamed Pharbil Arzneimittel GmbH）用作其他通用品牌阿莫西林、头孢曲松和环丙沙星的参考品牌。
从目标地区共采集了 31 个品牌（10 个不同品牌的阿莫西林胶囊、9 个头孢曲松钠注射剂和 12 个环丙沙星片），并进行了质量控制测试。所有采集品牌的样本均符合各自药典专论的要求。
在符合各自药典专论的要求方面，非洲和亚洲制造的阿莫西林胶囊、头孢曲松注射剂和环丙沙星片与欧洲制造的品牌之间没有明显的质量差异。
