同时分析药物制剂中6种抗逆转录病毒药物的高效液相色谱方法的建立与验证

Mankulu Kakumba Jocelyn, M. Augustin, Mbenza Puati Adelard, M. Jeremie, Kimbeni Malongo Tresor
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引用次数: 4

摘要

艾滋病毒/艾滋病是世界上最严重的公共卫生问题之一,影响到非洲相当多的人口;特别是在刚果民主共和国,获得良好的抗逆转录病毒药物治疗仍然是一个大问题。为了提高艾滋病毒/艾滋病感染者的生活质量,迫切需要确保为每一个有需要的人提供高质量和大量的药品。药品的有效性和安全性首先取决于其质量,其次取决于其使用以刚果民主共和国为例,我们估计在2011-2015年期间,在100万艾滋病毒/艾滋病感染者中,只有35万人接受了抗逆转录病毒治疗。这一数字仅在接受抗逆转录病毒药物有效治疗的4.4万名患者中有所下降,3即抗逆转录病毒药物治疗覆盖率为14%。这是世界上最低的比率,表明有30多万人有需要但没有得到服务如今,人们可以说情况没有改变,艾滋病毒/艾滋病患者面临着紧急情况。除了难以获得抗逆转录病毒治疗之外,抗逆转录病毒产品还可能产生另一个重要问题,即它们的质量!抗逆转录病毒药物是用于治疗艾滋病毒感染的药物。它们的作用是降低病毒DNA的复制速度,同时阻止病毒在体内的繁殖。自从启动货币资助和药物获取计划项目以来,抗逆转录病毒药物治疗免费向公众提供,但在一些国家,获得治疗仍然是一个问题。不幸的是,刚果民主共和国的情况就是如此,该国根据世卫组织的新建议,于2003年制定了国家艾滋病毒治疗指南,并于2005年、2008年和2010年进行了审查。6,7对于进口国来说,在投放市场使用之前,根据国家指南和制造商提交给公共卫生当局的数据证明抗逆转录病毒药物的质量是非常重要的
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and validation of HPLC methods for simultaneous analysis of 6 antiretrovirals in pharmaceutical formulations
HIV/AIDS is one the world’s most serious public health problems and affects an important number of populations in Africa; particularly in the Democratic Republic of the Congo (DRC) where the access to a good antiretrovirals (ARVs) treatment remains a big issue. To increase the life quality of people living with HIV/AIDS, it is urgent to secure medicines of good quality and in good quantity for everyone in need. The drugs efficiency and safety depend first on their quality, and secondly on their use.1 In the particular case of DRC, we estimated that among one million people living with HIV/AIDS2 only 350,000 were having ARV treatment in 2011-2015. This number, decreased only in 44 000 patients who were effectively treated with ARVs,3 which represented a coverage of 14 % ARV treatment. This was the lowest rate in the world and shows that more than 300 000 people were in need but were not served.4 Nowadays, one can tell that the situation remains unchanged and there is an emergency for the HIV/AIDS living people. In addition to poor accessibility to ARV treatment, another important question may arise from the ARV products, and this concerns their quality! Antiretrovirals are medicines used to treat the HIV infection. They act by reducing the viral DNA replication speed, stopping at the same time its propagation in the body5. Since the launch of Monetary Found and Medicines Access Program projects, the ARV treatment is given to the public for free, but their access stills a problem in some countries. This is unfortunately the case of the DRC, where the national guide of HIV treatment was elaborated in 2003 and reviewed in 2005, 2008 and 2010, following the new recommendations of WHO.6,7 For importer countries, it is very important to certify the ARV quality according to the national guidelines and the manufacturer data submitted to the public health authorities before their launch in the market for use.8
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