Influence of the GB-03 Needle-free Injector on the Biological Activity of Recombinant Human Insulin Injection

OBJECTIVE To evaluate the influence of the GB-03 needle-free injector (NFI) on the biological value of recombinant human insulin injection(rHI); to examine whether the NFI administration is bioequivalent to the traditional subcutaneous(S.C.) administration for rHI. METHODS A twin cross-over designed biological assay method in mice was carried out to determine the potency of the NFI treated rHI (the untreated rHI as the standard); the concentration of serum glucose was measured in 6 h after needle-free or traditional S.C. administration of 0.4 unit·kg^-1 rHI in rabbits. RESULTS The estimated potency of rHI was 109.7% of the labeled potency in mice. There was no significantly difference between the concentration of the serum glucose of the needle-free group and the S.C. group. CONCLUSION The GB-03 needle-free injector has no significant influence on the biological value of rHI. The NFI administration is bioequivalent to the traditional S.C. administration for rHI in rabbits.