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作者研究了7家欧洲工厂的18批抗D免疫球蛋白(Ig)制剂的稳定性。分别于试验开始、4℃贮存3、6、12、18、24、30及36月后以及于37℃贮存28天后取样测抗D效价,纤维蛋白溶酶(Pm)和纤维蛋白溶酶原(Pmg)活性,前血管舒缓素激活剂活性(PKA)和分子大小。于4℃贮存末取样做免疫电泳和Ouchterlony免疫试验以及观察有否其他血浆蛋白。对上述试验能否预测抗D效价稳定性也进行了研究。欧洲药典要求,制剂经37℃孵育28天其抗D活性损失不应超过原值20％。结果发现有2批分别达36.1％和20.2％。但18批平均活性损失12.3±8.2％,而4℃3年贮存后其平均活性损失达15.2±9.5％,较前者略高。两种条件下活性损失相关系数r=0.61,P<0.05,说明28天孵育结果能预测4℃36月贮存后抗DIg的稳定性。 37℃天28天与4℃3年的Pm和Pmg活性与抗
The authors studied the stability of 18 batches of anti-D immunoglobulin (Ig) preparations in seven European facilities. The anti-D titers, plasmin (Pm) and plasminogen were sampled at the beginning of the experiment, after storage for 3, 6, 12, 18, 24, 30 and 36 months at 4 ° C and for 28 days at 37 ° C (Pmg) activity, pro-angiotensin-activator activity (PKA), and molecular size. Samples were stored at 4 ° C for immunoelectrophoresis and Ouchterlony immunoassay and to observe for any other plasma proteins. The above test can predict the stability of anti-D potency has also been studied. The European Pharmacopoeia requires that the anti-D activity loss of the preparation after incubation for 28 days at 37 ° C should not exceed 20% of its original value. As a result, two batches were found to reach 36.1% and 20.2% respectively. However, the average activity loss of 18 batches was 12.3 ± 8.2%, while the average activity loss after 3-year storage at 4 ℃ reached 15.2 ± 9.5%, slightly higher than the former. The correlation coefficient of activity loss between the two conditions was r = 0.61, P <0.05, indicating that the 28-day incubation predicted the stability of anti-DIg after storage at 36 ℃ for 4 months. Pm and Pmg activity and resistance at 37 ℃ for 28 days and 4 ℃ for 3 years