鼻用双链核糖核酸抗病毒活性及药理安全性研究

S. G. Gamaley, G. G. Shimina, E. S. Tsyplenkova, O. V. Simakova, M. Skarnovich, M. A. Skarnovich, L. Shishkina, O. Taranov, O. S. Ivanova, G. M. Levagina, E. Danilenko
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引用次数: 0

摘要

干扰素诱导剂作为抵御病毒感染(包括流感)的第一道防线,引起了人们的兴趣。用于鼻内给药的双链核糖核酸(dsRNA)已经开发,赋形剂和药物成分是在国家病毒学和生物技术研究中心“载体”分支机构医学生物技术研究所选择的。本文介绍了一种新型dsRNA的抗病毒活性和药理安全性的研究结果。研究了该制剂对感染甲型流感病毒/爱知/2/68 (H3N2)和比什凯克/01/2009 (H1N1pdm09)的BALB/c小鼠的抗病毒活性。一项安全性研究通过单次给药鼻内dsRNA到白色杂交ICR小鼠。研究表明,治疗性和预防性的鼻内dsRNA剂量为2.5 mg/kg,可提高感染上述流感病毒株的小鼠的存活率和平均预期寿命。该制剂对感染致死剂量比什凯克/01/2009病毒的小鼠的保护作用与达菲的作用相当。实验小鼠鼻内dsRNA在药理学剂量下无毒性作用,实验确定了小鼠生理系统的功能状态以及主要代谢类型,得出了有关该制剂的药理学安全性的结论,并展望了进一步工作以完成新型抗病毒药物的药物开发。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Study on Antiviral Activity and Pharmacological Safety of Double-Stranded Ribonucleic Acid for Intranasal Administration
Interferon inducers are of interest as the first line of defense against viral infections, including influenza. Double-stranded ribonucleic acid (dsRNA) for intranasal administration has been developed, the excipients and drug components were selected at the Institute of Medical Biotechnology, a branch of the State Research Center of Virology and Biotechnology «Vector». This work presents the results of the study on antiviral activity and pharmacological safety of a new form of dsRNA. The antiviral activity of the preparation was studied in BALB/c mice infected with influenza A/Aichi/2/68 (H3N2) or Bishkek/01/2009 (H1N1pdm09) viruses. A safety study was performed with a single administration of intranasal dsRNA into white outbred ICR mice. The study showed that the administration of therapeutic and prophylactic regimen of intranasal dsRNA at a dose of 2.5 mg/kg increases the survival and average life expectancy of mice infected with the mentioned strains of influenza virus. The protective effect of the preparation in mice infected with a lethal dose of Bishkek/01/2009 virus was comparable to the effect of Tamiflu. The absence of toxic effects of intranasal dsRNA at a pharmacological dose in laboratory mice, the functional state of their physiological systems, as well as main types of metabolism, established in the experiments, lead to a conclusion concerning pharmacological safety of the preparation and the prospects for further work to complete pharmaceutical development of a new antiviral drug.
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