目的 研究重組人干擾素β-1a注射液對實驗動物中樞神經(jīng)系統(tǒng)、呼吸系統(tǒng)、心血管系統(tǒng)以及消化系統(tǒng)的影響，觀察藥物潛在的對生理功能的不良影響，為臨床實驗提供依據(jù)及參考。方法 小鼠單次sc重組人干擾素β-1a注射液5.5、22.0、88.0 μg/kg，觀察小鼠自主活動，進行平衡協(xié)調(diào)能力和協(xié)同睡眠實驗，研究藥物對動物中樞神經(jīng)系統(tǒng)的影響；食蟹猴單次sc重組人干擾素β-1a注射液1、4、16 μg/kg，觀察食蟹猴的心電、血壓、呼吸頻率、呼吸幅度，研究藥物對動物呼吸系統(tǒng)和心血管系統(tǒng)的影響；小鼠單次sc重組人干擾素β-1a注射液5.5、22.0、88.0 μg/kg，進行胃腸推進實驗，研究藥物對胃腸消化系統(tǒng)的影響。結(jié)果 小鼠單次sc重組人干擾素β-1a注射液，5.5、22.0、88.0 μg/kg劑量組動物自主活動、平衡運動能力未見明顯變化、未見與閾下劑量戊巴比妥鈉協(xié)同睡眠作用，且未見胃腸推進的明顯變化；食蟹猴單次sc重組人干擾素β-1a注射液，1、4、16 μg/kg劑量組動物未見明顯劑量或時效相關(guān)性的心血管、呼吸系統(tǒng)影響。結(jié)論 重組人干擾素β-1a注射液對實驗動物的中樞神經(jīng)系統(tǒng)、呼吸系統(tǒng)、心血管系統(tǒng)及消化系統(tǒng)均未見明顯藥物影響。

Objective To research the drug effects on laboratory animals' central nervous system, respiratory system, cardiovascular system and digestive system of recombinant human interferon β-1a injection under the certain dosages thereby observing the potential adverse effects on physiological functions and providing basis and reference for clinical experiment.Methods The mice received a single dose of 5.5, 22.0, and 88.0 μg/kg of recombinant human interferon β-1a injection by sc injection and the effects on central nervous system were studied by observing the autonomic activity of mice, carrying out balance and coordination ability test and coordinating sleep experiments. The cynomolgus monkeys received a single dose of 1, 4 and 16 μg/kg of recombinant human interferon β-1a injection by sc injection and the effects on respiratory system and cardiovascular system were observed. The mice received a single dose of 5.5, 22.0, and 88.0 μg/kg of recombinant human interferon β-1a injection by sc injection and the effects on digestive system were observed through gastrointestinal propulsion experiment.Results No significant changes in spontaneous activities of mice after a single dose of 5.5, 22.0 and 88.0 μg/kg of recombinant human interferon β-1a injection administration were found. The balance and exercise abilities of mice showed no impacts. No function together with subthreshold dose of sodium pentobarbital to cause mice sleep were found. No significant changes in respiratory and cardiovascular system of cynomolgus monkeys after a single dose of 1, 4 and 16 μg/kg of recombinant human interferon β-1a injection by hypodermic injection were found. No significant changes in gastrointestinal propulsive effect of mice after a single dose of 5.5、22、88 μg/kg of recombinant human interferon β-1a injection by hypodermic injection were found.Conclusions Recombinant human interferon β-1a injection showed no significant influences on laboratory animals' central nervous system, respiratory system, cardiovascular system and digestive system.

國家科技重大新藥創(chuàng)制項目（2015ZX09501004）；天津市科技計劃項目（16PTGCCX00090）