Pharmacopoeial quality of drugs supplied by Nigerian pharmacies
Pharmacopoeial quality of drugs supplied by Nigerian pharmacies
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DOI：
10.1016/s0140-6736(00)05065-0
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发表时间：
2001-06-16
期刊：
影响因子：
168.9
通讯作者：
Kolawole, JA
中科院分区：
文献类型：
--
作者：
Taylor, RB;Shakoor, O;Kolawole, JA
一些欠发达国家的药品质量在有效成分含量方面不足。药品质量差的原因包括欠发达国家普遍存在假药现象，高温和高湿导致活性成分过度分解，以及药品生产过程中质量保证差。我们的目的是调查从零售药店在两个城市地区的尼日利亚，不同的药物的质量，并在质量差的情况下，以确定原因whyse.Methods我们随机收集了581个样品，27种不同的药物，从35家药店在拉各斯和阿布贾在尼日利亚。我们分析了药物含量的药物通过验证色谱方法，并将我们的结果与药典的要求进行了比较。结果279（48%）样品不符合药典规定的限度，这一比例是统一的各种类型的药物测试。虽然有些制剂不含活性成分，但大多数制剂的含量刚好超出药典限度。我们发现样品中的活性药物含量过多和过少。解释药品质量差的最可能原因是在生产过程中缺乏足够的质量保证。欠发达国家药店出售的不合格药品可能导致全球微生物抗药性和传染病治疗失败。
Background The quality of medicines available in some less-developed countries is inadequate in terms of content of active ingredient. Reasons for the poor quality of drugs include widespread counterfeiting of medicines in less-developed countries, excessive decomposition of active ingredient as a result of high temperature and humidity, and poor quality assurance during the manufacture of medicinal products. Our aim was to investigate the quality of different drugs obtained from retail pharmacies in two urban areas of Nigeria, and, in instances of poor quality, to ascertain the reason why.Methods We randomly collected 581 samples of 27 different drugs from 35 pharmacies in Lagos and Abuja in Nigeria. We analysed the medicines for drug content by validated chromatographic methods, and compared our results with pharmacopoeial requirements.Findings 279 (48%) samples did not comply with set pharmacopoeial limits, and this proportion was uniform for the various types of drugs tested. Although some preparations contained no active ingredient, most had amounts just outside the pharmacopoeial limits. We identified samples with both too much and too little active drug content.Interpretation The most probable cause of the poor quality of drugs is absence of adequate quality assurance during manufacture. Substandard drugs sold in the pharmacies of less-developed countries could contribute to global microbial resistance and therapeutic failure of infectious diseases.