To observe the acute toxicity of recombinant porcine interferen-alpha （IFN-alpha） in mice and thus provide a basis for the clinical safety. [Method] According to the principles of acute toxicity, all the mice were divided into two major groups （intraperitoneally injected group and intramuscularly injected group） respectively at high dose, moderate dose and low dose. And the normal control group was also set up. Within 14 d after administration, the behavior of mouse and the degree of toxicity were continuously observed. The hematological indexes and biochemical indexes of blood were detected to obtain the preliminary toxicity data of the recombinant porcine IFN-alpha. And at the end of the experiment, mice were sacrificed for autopsy. [ Result] There was not significant difference in external performance, behavioral characteristics, body temperature, weight, pathological anatomy of visceral organs, hematological indexes and biochemical indexes between the experimental groups and the control group. [ Conclusion] The highest dose of porcine interferon （5.0 x 10s IU per mouse） in this experiment or the dose lower than this dosage should not have significant toxic effects on mice, and the recombinant porcine IFN-alpha is safe in clinical application.
[Objective]The research aimed to test and identify the physicochemical characters and antiviral activity in vitro of semi-finished product of the recombinant porcine rPoIFN-α. [Method]HEp-2/VSV system was used to test the antiviral activity of three batches of rPoIFN-α. Using recombinant human IFN-α as reference,the titer of interferon was measured. The semi-finished product of rPoIFN-α with the known titer were treated with 0.25% trypsin,HCl and mouse anti-porcine IFN-α monoclonal antibody. And the anti-viral activity of each batch of rPoIFN-α was detected. The physicochemical characters of rPoIFN-α were evaluated. The inhibition of induced cytopathic effect of rPoIFN-α on PPV （Porcine parvovirus） and PRV （Porcine pseudorabies） on swine kidney cell （PK-15） was determined. And the antiviral activity of rPoIFN-α in vitro was observed. [Result]The titers of semi-finished products of rPoIFN-α titrated by HEp-2/VSV system could reach 1.5×105 IU/ml,with the specific activity of 1.1×106 IU/mg. The residual rate of the tier of rPoIFN-α treated by 0.25% trypsin at 37 ℃ for 1 h was less than 1%. And that treated with HCl （pH of 2.0） for 72 h was up to 95%. And that treated at 56 ℃ for 30 min and that treated by mouse anti-porcine IFN-α monoclonal antibody at 37 ℃ for 1 h were higher than 47% and about 1% respectively. The antiviral test in vitro showed that 50 and 500 IU/ml rPoIFN-α could inhibit the induced cytopathic effect of PRV and PPV on PK-15 cell lines. [Conclusion]rPoIFN-α had the basic physicochemical characters of IFN-α. And it could inhibit the induced cytopathic effect of PRV and PPV on PK-15 cell lines,but there was dosage difference.
