Pinho A R, Fortuna A, Falcão A, Santos A C, Seiça R, Estevens C, Veiga F, Ribeiro A J
Laboratory of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
J Pharm Anal. 2019 Jun;9(3):143-155. doi: 10.1016/j.jpha.2019.02.001. Epub 2019 Feb 26.
The development of biotechnology-based active pharmaceutical ingredients, such as GLP-1 analogs, brought changes in type 2 diabetes treatment options. For better therapeutic efficiency, these active pharmaceutical ingredients require appropriate administration, without the development of adverse effects or toxicity. Therefore, it is required to develop several quantification methods for GLP-1 analogs products, in order to achieve the therapeutic goals, among which ELISA and HPLC arise. These methods are developed, optimized and validated in order to determine GLP-1 analogs, not only in final formulation of the active pharmaceutical ingredient, but also during preclinical and clinical trials assessment. This review highlights the role of ELISA and HPLC methods that have been used during the assessment for GLP-1 analogs, especially for exenatide.
基于生物技术的活性药物成分（如GLP-1类似物）的发展给2型糖尿病的治疗选择带来了变化。为了获得更好的治疗效果，这些活性药物成分需要适当给药，且不会产生不良反应或毒性。因此，需要开发多种GLP-1类似物产品的定量方法，以实现治疗目标，其中包括酶联免疫吸附测定法（ELISA）和高效液相色谱法（HPLC）。开发、优化和验证这些方法是为了不仅能在活性药物成分的最终制剂中测定GLP-1类似物，还能在临床前和临床试验评估期间进行测定。本综述重点介绍了在GLP-1类似物评估过程中，尤其是对艾塞那肽的评估中所使用的ELISA和HPLC方法的作用。
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