尼日利亚阿布贾市售的9个品牌盐酸二甲双胍片的质量评价

Olubukola A. Odeniran1,, O. Olayemi, I. Galadima, R. A. Kirim, C. Isimi, K. Mustapha
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引用次数: 0

摘要

二甲双胍是治疗II型糖尿病的首选药物,尼日利亚市场充斥着许多品牌的二甲双胍片剂。本研究的目的是评价阿布贾药店流通的9个品牌二甲双胍片的药品质量。采用官方方法对各品牌的重量、硬度、脆性、崩解时间和体外溶出度进行均匀性评价。用分光光度法测定了有效成分的含量。所有品牌的重量都在官方限制范围内,硬度发现不同品牌的值在1.20至11.50 kgF之间。脆性值在0.00 ~ 2.25%之间,崩解时间在2.06 ~ 10.36 min之间,符合薄膜包衣片的标准。60 min内释放度在93 ~ 103%之间,但其中一个品牌超出了官方标准的下限,因此溶出度试验不合格。同样,除了一个品牌外,所有品牌的活性成分含量都在官方规定的百分比范围内。研究结果强调了定期对药品进行市场监测的必要性,以保障患者的健康。
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Quality assessment of nine brands of metformin hydrochloride tablets marketed in Abuja, Nigeria
Metformin is a drug of first choice in management of type II diabetes mellitus and the Nigerian market is flooded with many brands of metformin tablets. The aim of this study is to assess the pharmaceutical quality of nine brands of metformin tablets circulating in pharmacy outlets in Abuja. The brands were assessed for uniformity in weight, hardness, friability, disintegration time and in vitro dissolution using official methods. The content of active ingredient was also determined spectrophotometrically. All the brands had weights within the official limits, hardness was found to differ across the brands with values ranging between 1.20 and 11.50 kgF. Friability values were between 0.00 and 2.25%, disintegration time was between 2.06 and 10.36 min and within official specifications for film-coated tablets. Drug release within 60 min was between 93 and 103%, however, one of the brands fell outside the lower limit of the official specification and therefore, failed the dissolution test. Similarly, all but one of the brands were within the official specification of the percent content of active ingredient. The results highlight the need to routinely carry out market surveillance on drug products so as to safeguard the health of patients.
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