Kenya Medical Research Institute, Centre for Traditional Medicine and Drug Research, Nairobi, Kenya.
PLoS One. 2021 Sep 22;16(9):e0257625. doi: 10.1371/journal.pone.0257625. eCollection 2021.
Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya.
A total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out.
The samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements.
This study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.
在发达国家和发展中国家，由于假冒伪劣、劣药或劣药进入市场，药品质量有时会受到影响。这是一个公共卫生问题，因为劣质药品会危及公众健康，使患者暴露于化学毒素和/或低于治疗剂量。这可能导致治疗效果降低，并促进耐药性的发展。复方磺胺甲噁唑是磺胺甲噁唑和甲氧苄啶的固定剂量组合，是一种广谱抗菌药物，也用于预防 HIV 感染者的机会性感染。本研究评估了肯尼亚内罗毕县市场上销售的选定复方磺胺甲噁唑混悬剂品牌的质量。
共采集了 106 个样本，分为 15 个品牌，按照美国药典进行了活性药物成分（API）和 pH 值的评估。API 的测定采用高效液相色谱法。结果与药典参考值进行比较。对标签进行了目视检查，并与药房和毒药管理局保留登记册确认了品牌的保留状态。
这些样本主要来自当地（86.7%）。2019 年 10 月 23 日，记录的 15 个品牌中的 6 个品牌的保留状态不再列在药房和毒药管理局保留登记册中。在测试的 106 个样本中，有 70.6%和 86.8%分别符合美国药典（USP）关于 pH 值和 API 的规格，而 84.0%符合包装和标签要求。
本研究表明，大多数测试的复方磺胺甲噁唑混悬剂都符合 USP 要求。此外，它还提供了劣质复方磺胺甲噁唑药物的证据，这些药物可能会影响儿童传染病的治疗。这强调了需要定期进行质量保证测试，以确保市场上只有高质量的药物。
