对具有精神活性的物质进行临床前研究和专家研究的科学、方法和组织方法

T. Malkova, P. S. Mashchenko, A. I. Andreev, D. Apushkin, E. V. Vikhareva
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摘要

简介研究药物的精神活性特性是监管其流通的一项重要任务。这既与非法流通的新精神活性物质(NPS)有关,也与进入医药市场的药物有关。在这方面,建立专门的分析中心以开展复杂的化学和药理学研究的问题并没有失去其现实意义。这项工作的目的是在总结彼尔姆国立药学院地区测试中心(RTC)"Pharmatest "员工的工作经验的基础上,制定对精神活性物质进行综合研究的科学、方法和组织方法。在开展这项工作时,使用了 2010-2023 年的实验和统计数据。根据 RTC "Pharmatest "对新精神活性物质进行了研究,以确定是否有可能将其归类为滥用药物的类似物;对新药物可能存在的精神活性特性和对某些受体的亲和力进行了研究;评估了进行各阶段专家检查的方法,并介绍了所使用的研究、化学和生物方法。研究新精神活性物质的各个阶段和对每种物质进行检测的方法,以及必要的设备和解释所得结果的方法,都已确定并得到科学证实。结论:有必要建立分析中心,对麻醉物质进行全面的专家研究和药物的临床前研究。为对新的精神活性物质进行全面研究而制定的方法原则和组织措施,对于打击非法贩毒以执行国家禁毒政策,以及开发国产药品以确保在医疗实践中使用有效和安全的药品,都具有重要意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Scientific, Methodological and Organizational Approaches to Conducting Pre-clinical and Expert studies of Substances with Psychoactive Properties
Introduction. Studying the psychoactive properties of substances is an important task for regulating their circulation. It is relevant both for new psychoactive substances (NPS) that are in illegal circulation and for drugs entering the pharmaceutical market. In this regard, the issue of creating specialized analytical centers for conducting complex chemical and pharmacological studies does not lose its relevance.Aim. The purpose of the work is to develop scientific, methodological and organizational approaches to conducting comprehensive studies of psychoactive substances based on generalizing the work experience of employees of the Regional Test Center (RTC) "Pharmatest" of the Perm State Pharmaceutical Academy, both in the study of new psychoactive substances, withdrawn from illegal circulation, as part of expert studies on behalf of law enforcement agencies, and as part of preclinical studies of new medicines.Materials and methods. When performing the work, experimental and statistical data for 2010–2023 were used. on the study of NPS on the basis of the RTC "Pharmatest" in order to determine the possibility of classifying them as analogues of drugs of abuse, materials on the study of new drugs for the possible presence of psychoactive properties and affinity for certain receptors, approaches to conducting individual stages of expert examinations were assessed and described research, chemical and biological methods used.Results and discussion. The stages of research into new psychoactive substances and the methodology for conducting tests on each of them, as well as the necessary equipment and approaches to interpreting the results obtained, have been determined and scientifically substantiated. The need to create analytical centers to conduct comprehensive expert studies of narcotic substances and preclinical studies of drugs is shown.Conclusion. The developed methodological principles and organizational measures for conducting a comprehensive study of new psychoactive substances are important both for suppressing illegal drug trafficking in order to implement the State anti-drug policy, and for the development of domestic pharmaceuticals, designed to ensure the use of effective and safe medicines in medical practice.
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