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首页> 外文期刊>Tropical Journal of Pharmaceutical Research >Quality of Artesunate Tablets Sold in Pharmacies in Kumasi, Ghana
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Quality of Artesunate Tablets Sold in Pharmacies in Kumasi, Ghana

机译:加纳库马西药房出售的青蒿琥酯片剂的质量

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Purpose: The study was carried out to evaluate the quality of artesunate tablets sold in retail and wholesale pharmacies in Kumasi, Ghana. In particular, the study sought to ascertain the presence or otherwise of counterfeit artesunate tablets in Kumasi. Method: Artesunate tablets were purchased from pharmacies in Kumasi for the study. The mechanical properties of the tablets were evaluated, namely: uniformity of weight, breaking strength, friability and rate of disintegration in aqueous medium. Colorimetric methods were used to determine the presence of artesunate and to assay the tablets. Result: None of the artesunate tablets sampled was found to be a counterfeit. Most of the brands had acceptable mechanical properties in terms of mass uniformity, hardness, friability and disintegration time. However, the artesunate content of the tablets was variable (47.9-99.9 %). Six (35.3 %) of the samples passed the International Pharmacopoeia content uniformity test (93.7-99.9 %) while 11 (64.7 %) failed the test (47.9-89.4 %). However, only 3 (17.6 %) of the samples met the European Pharmacopoeia (Ph. Eur.) content requirements while 14 (82.4 %) failed to meet the requirements. Conclusion: The presence of substandard artesunate tablets on the Ghanaian market should alert drug regulatory authorities to be vigilant and continually monitor the quality of this life-saving drug.
机译:目的:进行该研究以评估在加纳库马西的零售和批发药房中出售的青蒿琥酯片剂的质量。特别地,该研究试图确定假冒青蒿琥酯片在库马西的存在与否。方法:青蒿琥酯片剂购自库马西的药店进行研究。评价片剂的机械性能,即:重量均匀性,断裂强度,易碎性和在水性介质中的崩解速率。使用比色法确定青蒿琥酯的存在并测定片剂。结果:采样的青蒿琥酯片剂均未发现是伪造的。大多数品牌在质量均匀性,硬度,脆性和崩解时间方面均具有可接受的机械性能。然而,片剂中的青蒿琥酯含量是可变的(47.9-99.9%)。六个(35.3%)样品通过了国际药典含量均匀度测试(93.7-99.9%),而11个(64.7%)未通过测试(47.9-89.4%)。但是,只有3个样品(17.6%)符合欧洲药典(Ph。Eur。)含量要求,而14个样品(82.4%)没有达到要求。结论:加纳市场上存在不合格的青蒿琥酯片剂,应提醒药物监管部门保持警惕,并不断监测这种救生药物的质量。

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