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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。
OBJECTIVE: To investigate the bioavailability and safety of rhIFNα2a-PBCA-NS (rhIFNα2a-PBCA-NS) in mice. Methods: The mice were treated with iv or ig, blood was taken after a certain time, rIFNα2a content was measured by cytopathic effect inhibition and the bioavailability was calculated. The acute toxicity test of lyophilized rIFNα2a-PBCA-NS iv, ip, ig administration , Local irritation test, vascular irritation test, hemolysis test and allergy test to determine its safety. Results: The bioavailability of rIFNα2a-PBCA-NS (3.39%) was 15-fold that of rIFNα2a (0.22%) and rIFNα2a was very low. RIFNα2a-PB-CA-NS was used in iv, ip and ig administration Toxicity were lower than PBCA-NS. CONCLUSION: The bioavailability of ig administration in rIFNα2a-PBCA-NS mice is significantly higher than that of rIFNα2a and has good safety.