Study of Acute Toxicity and Irritant Effect of Nasal Spray Naltrexone Hydrochloride

Q3 Pharmacology, Toxicology and Pharmaceutics
Y. Domnina, V. V. Suslov, S. Kedik, D. A. Akhmedova, A. Malkova
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引用次数: 1

Abstract

Introduction. Acute toxicity of naltrexone hydrochloride nasal spray during intragastric administration to mice and local irritant effect on rabbits was studied. At all stages of the experiment, observations were made on the General condition of the animals. The state of homeostasis was evaluated using functional, hematological and morphometric methods. According to the results of research, there was no local irritant effect on the eyes of rabbits, as well as no toxic effect of high doses of the drug on animals. Introduction. Naltrexone hydrochloride in doses of 1.5– 5 mg/day has shown its effectiveness in the treatment of a number of diseases. Due to the lack of such a "low-dose" naltrexone registered on the pharmaceutical market, we have developed the composition of the nasal spray naltrexone hydrochloride. One of the stages of our research is to study the safety of the drug being developed. The first step in this direction was to study its acute toxicity and local irritant effect.Aim. Study of acute toxicity and local irritant effect of naltrexone hydrochloride nasal spray.Materials and methods. The object of the study was a nasal spray of naltrexone hydrochloride. Acute toxicity studies were performed on outbred adult mice (females). Study of local irritant effect on Soviet chinchilla rabbits (males).Results and discussion. The study of acute toxicity showed that the drug, at a dose significantly higher than the estimated maximum daily therapeutic dose for humans, did not have a significant toxic effect on the body of laboratory animals. The presence of a local irritant effect in the studied drug was not established in the framework of the experiment.Conclusion. As part of the experiment, the drug under study did not have a local irritant or toxic effect on the animal body. The results obtained allow us to continue the development and study of the nasal spray naltrexone hydrochloride.
盐酸纳曲酮鼻喷雾剂的急性毒性及刺激性研究
介绍。研究了盐酸纳曲酮鼻喷雾剂对小鼠的急性灌胃毒性和对家兔的局部刺激作用。在实验的各个阶段,都对动物的一般情况进行了观察。使用功能、血液学和形态计量学方法评估体内平衡状态。研究结果显示,对家兔眼睛无局部刺激作用,大剂量用药对动物无毒性作用。介绍。盐酸纳曲酮剂量为1.5 - 5mg /天,已显示其治疗多种疾病的有效性。由于医药市场上缺乏这种“低剂量”纳曲酮的注册,我们开发了鼻喷剂盐酸纳曲酮的成分。我们研究的一个阶段是研究正在开发的药物的安全性。第一步是研究其急性毒性和局部刺激作用。盐酸纳曲酮鼻喷雾剂急性毒性及局部刺激作用的研究。材料和方法。研究对象是盐酸纳曲酮鼻腔喷雾剂。急性毒性研究在近亲繁殖的成年小鼠(雌性)上进行。苏联栗兔(雄性)局部刺激效应的研究。结果和讨论。急性毒性研究表明,该药物的剂量明显高于估计的人类每日最大治疗剂量,但对实验动物的身体没有明显的毒性作用。在实验框架内,未确定所研究药物是否存在局部刺激作用。作为实验的一部分,所研究的药物对动物身体没有局部刺激或毒性作用。所得结果为继续开发和研究盐酸纳曲酮鼻喷雾剂提供了依据。
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来源期刊
Drug Development and Registration
Drug Development and Registration Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
1.20
自引率
0.00%
发文量
61
审稿时长
8 weeks
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