人白细胞介素2国家标准品的制备及其特性研究

人白细胞介素2;标准品;效价

本研究制备了人白细胞介素2国家标准品并分析其特性,首先对人白细胞介素2活性测定进行了研究,保证了该方法的灵敏可靠,对标准品配方进行筛选,得到了最佳的配方.在完成标准品的制备后,国内外对效价进行了联合标定,确定了人白细胞介素2国家标准品的效价为400IC/支,经过2年6个月37℃等多种温度的保存,效价均未下降,经化学动力学实验表明,理论有效期在100年以上,说明我们研制的标准品稳定性达到了国际上人白细胞介素2标准品的水平.

In the present study, the human interleukin-2 speciman of national standard was prepared and its characteristics was analysed. The method of detemining the activity of rhIL-2 was studied to eresure its sensitivety and reliability. We screened the standard prescriptions to obtain the optical one. After finishing the preparation of standard specimen, we determined the potency of rhIL-2 both at home and abroad. The potency of human interleukin-2 of national standard specimen is 4001U/ampoule, which didn't change during two and a half years of storing under the conditions of 37℃ . Kinetic experiments showed that theoretically standard shelf life is more than one hundred years in 4℃ , indieating that the sta-blitv of our rhIL-2 reached the internitional of human interleukin-2.