Acute Toxicity of Hydrogel Polyhexamethylene Guanidine Hydrochloride

S. Lebedeva, O. Ochirov, M. Grigoryeva, S. Zhamsaranova, S. Stelmakh, D. Mognonov
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Abstract

Background. Previously, we have shown that the polyhexamethylene guanidine hydrochloride hydrogel exhibits a pronounced wound healing. At the same time, no studies of the toxic effect of the hydrogel on animals have been conducted. Aim of the research. In the framework of this work, the acute toxicity of the hydrogel polyhexamethylene guanidine hydrochloride was studied in laboratory animals with intragastric administration. Materials and methods. The polyhexamethylene guanidine hydrochloride hydrogel was obtained by crosslinking the amino end groups with formaldehyde. An acute toxicity study was carried out (P 1.2.3156-13, GOST 32644-2014 and the Guidelines for conducting preclinical studies of drugs) in an experiment on outbred mice with a single addition of the test substance in different doses (1000, 3000, 5000, 8000 mg/kg) with fixing indicators (appearance, behavior, condition of the body hair coat, water and food consumption, excretion, body weight and its growth) during 14 days. After the animals were withdrawn from the experiment, autopsy, macroscopic evaluation and weighing of the internal organs were performed. The results showed that with the introduction of the test substance into the animal organism, death during the observation period (14 days) did not occur. It was not possible to determine the semi-lethal dose for the test compound. Conclusion. The conducted studies allow us to conclude that this substance is practically non-toxic and can be classified as hazard class V. Further research will be directed to the formation of hydrogel compositions with medicinal substances.
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盐酸聚六亚甲基胍水凝胶的急性毒性研究
背景。以前,我们已经表明,聚六亚甲基胍盐酸盐水凝胶表现出明显的伤口愈合。同时,还没有对水凝胶对动物的毒性作用进行过研究。研究的目的。在本研究的框架内,研究了水凝胶聚六亚甲基胍盐酸盐在实验动物中灌胃的急性毒性。材料和方法。将氨基端与甲醛交联,得到了聚六亚甲基胍盐酸盐水凝胶。采用外交种小鼠进行急性毒性研究(P 1.2.3156-13, GOST 32644-2014和药物临床前研究指南),分别以不同剂量(1000、3000、5000、8000mg /kg)单次添加试验物质,固定14天的试验指标(外观、行为、体毛状况、饮水和食物消耗、排泄、体重及其生长)。动物退出实验后,进行解剖、宏观评价和内脏称重。结果表明,将试验物质引入动物机体后,观察期内(14 d)未发生动物死亡。不可能确定试验化合物的半致死剂量。结论。所进行的研究使我们得出结论,该物质实际上是无毒的,可以被归类为危害类v。进一步的研究将针对与药用物质形成水凝胶组合物。
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