Field Study on the Assessment of Antimalarial Drug Quality Using Minilab Kit in India

Saba Noor, Supriya Sharma, Taruna Arora
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Abstract

A lack of proper anti-malarial medication use can lead to drug resistance, failed therapy, and even death. It is unclear how widespread the use of fake anti-malarial medications is in India. Better malaria treatment and the execution of regulatory initiatives to improve anti-malarial drug quality necessitate regional research into the quality of available anti-malarial pharmaceuticals. This study aimed to look into the quality of anti-malarial drugs in regions of India where malaria is common. Conclusions about the prevalence of substandard anti-malarial medications in Indian communities can be drawn from the findings. Samples of anti-malarial pills were bought from stores in five different Indian areas. One hundred and fifty anti-malarial drug samples were gathered. Using a GPHF minilab lab kit, the quality of the following samples was determined: chloroquine (n=50), artemether lumefantrine (n=50), artesunate sulphadoxine-pyrimethamine (n=14), and primaquine (n=31). This research confirmed that 98% of the tablets disintegrated properly in a minilab disintegration test. As a result, when compared to both the full set of standards and 80% of the samples, 99% of the samples passed the preliminary qualitative TLC test. Only 4% of samples (those with insufficient amounts of the active medicinal component) failed the quantitative HPLC test. Anti-malarial medicine counterfeiting has been found to be quite uncommon in India compared to other countries. However, further research is needed, such as post-marketing surveillance, to ensure that effective anti-malarials are distributed to the public.
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使用 Minilab Kitin 对印度抗疟药物质量进行评估的实地研究
抗疟疾药物使用不当会导致耐药性、治疗失败,甚至死亡。目前还不清楚印度使用假抗疟药的普遍程度。为了更好地治疗疟疾并实施监管措施以提高抗疟疾药物的质量,有必要对现有抗疟疾药物的质量进行地区性研究。本研究旨在调查印度疟疾流行地区的抗疟疾药物质量。研究人员从印度五个不同地区的商店购买了抗疟疾药样品。从印度五个不同地区的商店购买了抗疟疾药样品,共收集了 150 份抗疟疾药物样品。使用 GPHF 微型实验室试剂盒测定了以下样本的质量:氯喹(50 个样本)、蒿甲醚-卢门蒽醌(50 个样本)、青蒿琥酯磺胺乙胺嘧啶(14 个样本)和伯氨喹(31 个样本)。因此,与全套标准品和 80% 的样品相比,99% 的样品通过了 TLC 初步定性测试。只有 4% 的样品(活性药物成分含量足够的样品)未能通过 HPLC 定量测试。然而,还需要进一步的研究,如上市后监督,以确保向公众分发有效的抗疟疾药物。
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