【摘要】 通过检测人免疫球蛋白制品中抗 HBs含量的变化情况 ,采用留样观察法和加速试验法对不同温度条件下的人免疫球蛋白有效期进行预测。结果表明 ,与常规留样观察法相比 ,加速实验法推测出的药物有效期出现一定的偏差 ,所以应用于人免疫球蛋白稳定性观察仅能提供参考性数据。人免疫球蛋白的有效期确定应以常规留样观察法测得的结果为最可靠的依据更多还原

【Abstract】 The expiration of human immunoglobulin stored at different temperature was respectively observed by means of detection of anti HBs titer. The results indicated that there was deviation between the routine regulation method and acceleration test. It drawn a conclusion that the expiration of Human immunoglobulin should be determined based on data of routine test other than acceleration test by using samples stored at different temprature.更多还原