采用多等温加速试验预测特异性免疫球蛋白的稳定性

To forecast the stability of the special immunoglobulin by accelerated degredation tests

目的 预测特异性免疫球蛋白的稳定性 ,为制品效期的确定提供依据。 方法 采用多等温加速试验 ,将制品放在三种不同温度下孵放 ,定期取出样品 ,测定效价 ,根据制品的效价下降情况推算其在效期内的稳定性。 结果 推测蓉生乙肝免疫球蛋白及蓉生破伤风免疫球蛋白在效期内的效价下降率分别为 2 .3 %和 3 .8%。

Objective To forecast the stability of the special immunoglobulin products, and to provide basic information for determining the shelf life of the products. Methods By accelerated degradation tests,the products of human hepatitis B immunoglobulin and human tetanus immunoglobulin were put at three different temperature condition for incubation . Some samples were taken out regularly during the incubation in order to test the potency of HBs antibodies and tetanus antibodies, and to estimate the stability of the products during the shelf life according to the decline of the antibodies titer. Results According to our test results, the declining rates of the titers of RongSheng hepatitis B immunoglobulin and human tetanus immunoglobulin were 2 3% and 3.8% respectively. Conclusion RongSheng hepatitis B immunoglobulin and human tetanus immunoglobulin have good stability during their shelf life.