BACKGROUND & AIMS:
:Substandard and counterfeit pharmaceutical products, including antimalarial drugs, appear to be widespread internationally and affect both the developing and developed countries. The aim of the study was to investigate the quality of antimalarial drugs, ie, artesunate (ART), chloroquine (CHL), mefloquine (MEF), quinine (QUI), sulfadoxine/pyrimethamine (S/P) and tetracycline (TT) obtained from the government sector and private pharmacies in 4 Thai provinces: Mae Hong Son, Kanchanaburi, Ranong, and Chanthaburi. Three hundred sixty-nine samples of 6 antimalarial drugs from 27 government hospitals, 27 malaria clinics, and 53 drugstores, were collected. Drug quality was assessed by simple disintegration test and semi-quantitative thin-layer chromatography in each province; 10% passed, 100% failed and doubtful samples were sent to be verified by high performance liquid chromatography (HPLC) at the Thai National Drug Analysis Laboratory, (NL). Fifteen point four percent of ART, 11.1% of CHL and 29.4% of QUI were substandard. Based on the finding, drug regulatory authorities in the country took appropriate action against violators to ensure that antimalarial drugs consumed by malaria patients are of good quality.
背景与目标:
: 不合格和假冒药品,包括抗疟药,在国际上似乎很普遍,对发展中国家和发达国家都有影响。该研究的目的是调查抗疟药的质量,即青蒿琥酯 (ART),氯喹 (CHL),甲氟喹 (MEF),奎宁 (QUI),从泰国4个省的政府部门和私人药房获得的磺胺多辛/乙胺嘧啶 (S/P) 和四环素 (TT): 湄宏顺,北碧府,拉农和Chanthaburi。收集了来自27家政府医院,27家疟疾诊所和53家药店的6种抗疟药物的369个样本。通过每个省的简单崩解试验和半定量薄层色谱法评估药物质量; 10% 通过,100% 个失败和可疑的样品被发送给泰国国家药物分析实验室 (NL) 的高效液相色谱法 (HPLC) 验证。ART的15个点4%,CHL的11.1% 和QUI的29.4% 不合格。根据这一发现,该国药品监管当局对违法者采取了适当的行动,以确保疟疾患者食用的抗疟药物质量良好。