基因重组人干扰素α2a聚氰基丙烯酸丁酯纳米球的生物利用度及安全性研究

Studies on Bioavallability and Safety of Poly-Butylcyanoacrylate Nanosphere of Human Recombinant Interferon a2a

目的:考察基因重组人干扰素α2a聚氨氰丙烯酸丁酯纳米球(rIFNα2a-PBCA-NS),小鼠ig给药的生物利用度及安全性。方法:小鼠经iv或ig给药,一定时间后取血,采用细胞病变抑制法测定rIFNα2a含量并计算生物利用度;通过冻干rIFNα2a-PBCA-NS iv,ip,ig给药的急性毒性试验、局部刺激性试验、血管刺激性试验、溶血试验及过敏性试验来确定其安全性。结果:rIFNα2a-PBCA-NS的ig生物利用度(3.39％)为原药rIFNα2a(0.22％)的15倍,rIFNα2a毒性很小,rIFNα2a-PB-CA-NS用于iv,ip,ig给药的毒性均低于PBCA-NS。结论:rIFNα2a-PBCA-NS的小鼠ig给药生物利用度明显高于原药rIFNα2a,且具有较好的安全性。

Objectives: To investigate the bioavaikbility and safety of poly-butylcyanoacrykte nanospheres of human recombinan interferon a2a(rIFNa2a- PBCA- NS)to be given to mice by ig. Methods; The mice's blood were regular time after iv or ig to de termine the content of rIFNa2a and calculate bioavaikbility. The safety was determined with iv,ip,ig freeze drying rIFNa2a- PB CA - NS by acute toxcity; local irritation; hemolysis; and anaphylaxis-text. Results:The bioavaikbility of ig rIFNa2a-PBCA-NS(3. 39%) was significantly higher(F<0.01) than that of ig rIFNa2a( 0.22%). and the toxicities of iv, ip, ig were lower than the lat ter. Conclusion:The bioavaikbility of rIFNa2a-PBCA NS, Whose safety is pretty good, is significantly higher that than of rIFNa2a.