Audit of the Physico-Chemical Quality of Amoxicillin Based Drugs Marketed in Senegal

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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Abstract

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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塞内加尔上市阿莫西林类药品理化质量审核
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。
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