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目的制备冻干人血浆补体,并观察其在4种不同保存温度条件下的稳定性。方法制备3批冻干人血浆补体,将每批样品分别保存在-70、4、25和37℃条件下,采用补体50%溶血试验测定于-70和4℃条件下保存第1、15、30、60、90、120、180、270、365天以及于25和37℃条件下保存第1、5、10、15、20、30、40、50、60、70、80、90、100、110、120天的CH_(50);细胞增殖-毒性检测法测定补体对抗CD_(20)抗体CDC活性检测的影响。结果-70和4℃保存的3批冻干人血浆补体,1年内CH_(50)平均下降了19.5%和36.3%,25和37℃保存的3批冻干人血浆补体,3个月CH_(50)平均下降了53.4%和60.7%。与上市补体和CH_(50)为30 U/ml的冻干人血浆补体相比,CH_(50)为15 U/ml的冻干人血浆补体对抗CD_(20)抗体CDC活性检测结果无影响。结论在-70和4℃条件下保存的冻干人血浆补体的CH_(50)相对较稳定,但随着保存温度的升高,CH_(50)下降有加速的趋势。CH_(50)大于15 U/ml的冻干人血浆补体可用于治疗性抗体CDC活性检测。
Objective To prepare freeze-dried human plasma complement and observe its stability under four different storage temperatures. Methods Three batches of lyophilized human plasma complement were prepared and each batch of samples were stored at -70, 4, 25 and 37 ℃, respectively. The hemoglobin was determined by 50% hemolysis assay at -70 and 4 ℃, 30, 60, 90, 120, 180, 270, 365 days and at 1st, 5th, 10th, 15th, 20th, 30th, 40th, 110, 120 days of CH_ (50); Cell proliferation - toxicity assay was used to determine the effect of complement on CDC activity of anti-CD20 antibody. Results Three batches of lyophilized human plasma complement preserved at -70 and 4 ℃ decreased 19.5% and 36.3% respectively on average within one year. Three batches of lyophilized human plasma complement preserved at 25 and 37 ° C, three-month CH_ ( 50) dropped by 53.4% and 60.7% on average. Lyophilized human plasma complement with CH50 (50) of 15 U / ml had no effect on the CDC activity of anti-CD20 antibody compared to the human complement and the lyophilized human plasma complement with a CH50 of 30 U / ml. Conclusion CH_ (50) of lyophilized human plasma complement preserved at -70 ℃ and 4 ℃ is relatively stable, but the decrease of CH_ (50) tends to accelerate with the increase of storage temperature. Lyophilized human plasma complement with a CH_ (50) greater than 15 U / ml can be used for the detection of therapeutic antibody CDC activity.