塞内加尔上市阿莫西林类药品理化质量审核

Coulibaly Dalané Bernadette, Sow Fatoumata Tata, Naco Mohamed El Béchir, N’Diaye Mahamar, Toure Hamadoun Abba, Mariko Madani, Dackouo Blaise, Diouf Diéry, Koumare Benoit Yaranga, Sarr Serigne Omar
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引用次数: 0

摘要

不适应的抗生素在个人层面上造成治疗效果问题,但也是一个严重的公共卫生问题。本研究的目的是用分析方法评价塞内加尔达喀尔地区42份阿莫西林仿制药的质量。100%目视检查合规;100%符合性均匀性测试;溶出度均大于80%(86.8% ~ 108.8%)。阿莫西林的检出含量:片剂(95.2% ~ 104.1%);胶囊(91.5% - 113.9%)和悬浮液可饮用(96.9% - 118.7%)。本研究样品100%符合欧美药典标准(90% - 120%)。因此,其他研究应以稳定性和降解产物的剂量为方向。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Audit of the Physico-Chemical Quality of Amoxicillin Based Drugs Marketed in Senegal
Non-compliant antibiotics pose problems of therapeutic efficacy at the level of the individual, but also a serious public health problem. The objective of our study was to evaluate the quality of generic amoxicillin (42 samples) by analytical methods in Dakar/Senegal. At 100% visual inspection of compliance; 100% compliance uniformity test; at the dissolution test all > 80% (86.8% to 108.8%). The presence of amoxicillin with the following contents: Tablets (95.2% to 104.1%); Capsules (91.5% to 113.9%) and Suspensions drinkable (96.9% - 118.7%). All the samples in our study are 100% compliant according to the European and American pharmacopoeias (90% - 120%). Other studies should therefore be oriented in the direction of stability as well as the dosage of degradation products.
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