实验制剂“费罗赛尔T”的临床前研究

V. Todoriuk, V. Hunchak, B. Gutyj, D. Gufriy, I. Hariv, R. Khomyk, R. O. Vasiv
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引用次数: 36

摘要

本文介绍了新型右旋铁糖酐制剂“Ferosel T”的临床前研究结果,该制剂含有铁和硒。实验大鼠胃中以预防剂量2ml /kg体重和治疗剂量4ml /kg连续3天口服铁胞菌T无毒性作用。将铁胞T以高于治疗剂量3倍和10倍的剂量引入胃中,没有确定其毒性作用。在皮下给药条件下,未观察到大鼠的死亡,仅对实验动物有短期抑制作用,给药剂量为10 ml/kg b.w。在预防和最佳治疗剂量下,该药物不影响肝脏的解毒功能。在大鼠中,以最大治疗剂量和可能的毒性剂量给予铁细胞T,其己烯醛睡眠时间相对于控制值高出32%和35%。实验动物在给予T铁细胞治疗剂量和最大治疗剂量21天后的情绪和行为反应调查未显示对神经系统有显著影响。在皮肤充血肿胀和皮肤厚度方面,预防剂量和治疗剂量的铁细胞T在兔皮肤上应用后均未引起局部刺激。经亚平面法给豚鼠单独注射药物“Ferosel T”0.1 ml,未引起脚掌肿胀反应。在进行的研究中,没有发现药物“Ferosel T”的过敏特性。在实验大鼠中,对其引入铁塞尔T的预防剂量对心、肝、脾和肾的体重可能产生的变化尚未确定。在大鼠中,以最佳治疗剂量给予铁细胞T,与对照组相比,脾脏和肝脏的重量分别高出10.3和6.4%。当以最大治疗剂量引入铁细胞T时,脾脏和肝脏的质量分别增加14.0%和15.0%。研究结果表明,药物“Ferosel T”用于预防和治疗动物是安全的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Preclinical research of the experimental preparation “Ferosel T”
The results of preclinical studies of the new ferrodextran preparation “Ferosel T”, which contains ferrum and selenium, are presented. It has been established that at oral administration of ferrocellus T in a prophylactic dose of 2 ml/kg b.w. and the therapeutic dose of 4 ml/kg for 3 days in a row in the stomach of laboratory rats did not show toxic effects. No toxic effect of T ferrocellus is established at introducing it into the stomach in doses in 3 and 10 times higher than the therapeutic ones. Under conditions of subcutaneous administration of the drug, the death of white rats was not observed, only short-term inhibition of laboratory animals, which was prescribed the drug in a dose of 10 ml/kg b.w. It was established that in the preventive and optimal therapeutic doses the drug did not affect the detoxification function of the liver. In rats, which ferrocellus T was administered at maximum therapeutic and possibly toxic doses, the duration of hexenal sleep was for 32 and 35% higher relative to control values. The investigation of the emotional and behavioral reactions of laboratory animals after administration of ferrocellus T for 21 days in therapeutic and maximum therapeutic doses did not show a significant effect on the nervous system. In terms of hyperemia and swelling of the skin and the thickness of the skin, ferrocellus T in prophylactic and therapeutic doses upon application to rabbit skin did not cause local irritation. Separate injection of the drug “Ferosel T” by sub-planar way to guinea pigs in 0.1 ml. did not cause swollen reactions of the paws. As a result of the conducted research, no allergenic properties of the drug “Ferosel T” were found. In laboratory rats, which were introduced ferrosel T in the prophylactic dose of probable changes in the weight of the heart, liver, spleen and kidneys is not established. In rats, which were administered ferrocellus T in an optimal therapeutic dose, in comparison with control weights of the spleen and liver, respectively, was in 10.3 and 6.4% higher. When introducing ferrocellus T at the maximum therapeutic dose, the mass of the spleen and liver was in 14.0 and 15.0% higher, respectively. The results of the studies indicate that the drug “Ferosel T” is safe when used for the prevention and treatment of animals.
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