GB-03无针注射器对重组人胰岛素注射液生物活性的影响

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

目的考察GB-03无针注射器对重组人胰岛素注射液生物活性的影响,比较无针注射与传统皮下注射重组人胰岛素注射液的生物等效性。方法采用小鼠双交叉实验生物检定法,用重组人胰岛素注射液(作为对照品)标定经无针注射器处理的重组人胰岛素注射液的生物效价;家兔常规皮下注射和无针注射器注射相同剂量的重组人胰岛素注射液,比较给药后6 h内血糖的变化。结果经无针注射器处理的重组人胰岛素效价为109.7%;在注射后6 h内观察,采用2种给药途径的家兔各时间点血糖值差异无统计学意义。结论 GB-03无针注射器对重组人胰岛素注射液生物活性无明显影响,家兔无针注射器注射重组人胰岛素注射液与皮下注射具有生物等效性。

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.