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[抗组胺制剂 dimebon 安全性的临床前研究]

[Preclinical study of the safety of the antihistaminic preparation dimebon].

作者信息

Golubeva M I, Shashkina L F, Proĭnova V A, Fedorova E A, Nechushkina L V

出版信息

Farmakol Toksikol. 1985 May-Jun;48(3):114-9.

PMID:2863167
Abstract

The antihistaminic drug dimebon was subjected to toxicological study. It was demonstrated that as regards the level of the mean lethal doses dimebon can be attributed to little toxic substances. Administration of the drug in the doses approximating the therapeutic ones (1 and 5 mg/kg) for 2 months did not produce any alterations in rats, guinea-pigs or dogs. When administered in high doses (10 and 70 mg/kg) the drug provoked compensated abnormalities of some functions of the liver and kidneys in the presence of moderate and reversible structural changes in these organs. Dimebon did not exert any local irritating effect on the gastrointestinal tract. Administration of the drug in doses of 150 and 300 mg/kg at different times of pregnancy (days 1-7, 8-13, 14-19) did not produce any embryolethal or teratogenic effects.

摘要

对抗组胺药 dimebon 进行了毒理学研究。结果表明,就平均致死剂量水平而言,dimebon 可归类为低毒物质。以接近治疗剂量(1 和 5 毫克/千克)给药 2 个月,对大鼠、豚鼠或狗未产生任何改变。当以高剂量(10 和 70 毫克/千克)给药时,该药物在这些器官存在中度且可逆的结构变化的情况下,引发了肝脏和肾脏某些功能的代偿性异常。dimebon 对胃肠道未产生任何局部刺激作用。在妊娠不同时期(第 1 - 7 天、第 8 - 13 天、第 14 - 19 天)以 150 和 300 毫克/千克的剂量给药,未产生任何胚胎致死或致畸作用。

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