埃塞俄比亚吉马地区固定剂量青蒿琥酯/苯芴醇产品质量。
Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia.
机构信息
Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium.
School of Pharmacy, Jimma University, PO Box 378, Jimma, Ethiopia.
出版信息
Malar J. 2019 Jul 15;18(1):236. doi: 10.1186/s12936-019-2872-1.
BACKGROUND
Malaria caused by Plasmodium vivax and Plasmodium falciparum is among the major public health problems in most endemic areas of the world. Artemisinin-based combination therapy (ACT) has been recommended as a first-line treatment for uncomplicated Plasmodium falciparum malaria almost in all endemic regions. Since ineffectively regulated medicines in resource limited settings could favour infiltration of poor quality anti-malarial medicines into pharmaceutical supply chain and jeopardize a positive treatment outcome, regular monitoring of the quality of anti-malarial medicines is critical. Thus, the aim of this study was to assess the quality of fixed dose combination (FDC) artemether (ART)/lumefantrine (LUM) tablets available in Jimma zone, Ethiopia.
METHODS
This study was conducted in Jimma zone, Ethiopia. A total of 74 samples of FDC ART/LUM (20 mg ART/120 mg LUM) tablets were collected from 27 public facilities. All samples were subjected to visual inspection and the relevant information was recorded. The samples were transported to Jimma University Laboratory of Drug Quality (JuLaDQ) and stored at ambient temperature (20 °C to 25 °C) until analysis. The Pharmacopoeial conform/non-conform methods and the risk-based Derringer's desirability function approach were employed to assess the pharmaceutical quality of the investigated products.
RESULTS
The visual inspection results revealed that there were no signs of falsified in the investigated products. Identification test results of samples indicated that all samples contained the stated active pharmaceutical ingredients (APIs). The results of uniformity of mass indicated that all samples complied with International Pharmacopoeial specification limits. The assay results, expressed as percent label claim (%lc) of ART (89.8 to 108.8%, mean ± SD = 99.1 ± 3.9%) and LUM (90.0 to 111.9%, mean ± SD = 98.2 ± 3.8%) revealed that, all samples complied with International Pharmacopoeia acceptance specification limits (i.e. 90-110%lc), except one generic product (IPCA Laboratories Ltd., India) which contains excessive LUM (111.9 ± 1.7%lc). The risk priority number (RPN) results revealed that assay (RPN = 392) is relatively the most critical quality attribute followed by identity (RPN = 280) and mass uniformity (40). Quality evaluation based on psycho-physical Harrington's scale revealed that more than 96% of samples were within the acceptable ranges (D ≥ 0.7-1.0).
CONCLUSIONS
Both Pharmacopoeial and risk-based desirability function approaches to quality evaluation applied to the investigated products revealed that above 96% FDC ART/LUM tablets circulating in public settings of Jimma zone are of good quality.
背景
由间日疟原虫和恶性疟原虫引起的疟疾是世界上大多数流行地区的主要公共卫生问题之一。在几乎所有流行地区，青蒿素为基础的联合疗法（ACT）都被推荐为治疗无并发症恶性疟原虫疟疾的一线药物。由于在资源有限的情况下，不受监管的药品可能会使劣质抗疟药品渗透到药品供应链中，并危及治疗效果，因此定期监测抗疟药品的质量至关重要。因此，本研究旨在评估在埃塞俄比亚吉马地区提供的固定剂量复方（FDC）青蒿素（ART）/咯萘啶（LUM）片剂的质量。
方法
本研究在埃塞俄比亚吉马地区进行。从 27 个公共设施中采集了 74 个 FDC ART/LUM（20 mg ART/120 mg LUM）片剂样本。所有样本均进行了目视检查，并记录了相关信息。样本被运送到吉马大学药物质量实验室（JuLaDQ），并在环境温度（20°C 至 25°C）下储存，直至分析。采用《药典》符合/不符合方法和基于风险的 Derringer 理想性函数方法评估所研究产品的药物质量。
结果
目视检查结果显示，所研究产品没有伪造迹象。样品的鉴别试验结果表明，所有样品均含有规定的活性药物成分（APIs）。质量均匀性结果表明，所有样品均符合《国际药典》规格限制。含量测定结果（以标签声称的百分比表示（%lc））显示，ART（89.8%至 108.8%，平均值±标准差=99.1±3.9%）和 LUM（90.0%至 111.9%，平均值±标准差=98.2±3.8%），所有样品均符合《国际药典》接受规格限制（即 90-110%lc），除了一种通用产品（印度 IPCA 实验室有限公司），其 LUM 含量过高（111.9±1.7%lc）。风险优先数（RPN）结果显示，含量测定（RPN=392）是相对最关键的质量属性，其次是鉴别（RPN=280）和质量均匀性（40）。基于哈林顿心理物理标度的质量评估显示，超过 96%的样品处于可接受范围（D≥0.7-1.0）内。
结论
应用于所研究产品的《药典》和基于风险的理想性函数方法的质量评估均表明，在吉马地区公共环境中流通的超过 96%的 FDC ART/LUM 片剂质量良好。
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