Miks B, Aleksandrowicz J, Kawiak J
Zakład Badania Surowic i Szczepionek PZH w Warszawie.
Med Dosw Mikrobiol. 1990;42(3-4):171-7.
The study was carried out on 111 series of human immunoglobulin preparations (81 series for intravenous use, 30 series for intramuscular use) produced abroad and in Poland. Kallikrein (KK) and prekallikrein activator (PKA) activities were identified using chromogenic substrate. S-2302 and proteinase inhibitors were tested by double immunodiffusion method. Several biochemical, biological and serological methods were also applied which are valid in the control of intravenous and intramuscular immunoglobulin preparations. It was found that trace amounts of PKA and KK are present in human immunoglobulin preparations for intravenous use such as Bioglobulina and Gamma-Venina (PKA 0.0092-0.0505 mu kat/L, and KK 0,-0.0093 mu kat/L). On the other hand normal human immunoglobulin preparations for intramuscular use had somewhat higher level of KK and PKA and anti-HBs Immunoglobulin preparations (5.50 mu kat/L and 153.91 mu kat/L) and Tetabulina preparations had very high levels of these factors as compared to remaining preparations (4.50 mu kat/L and 316.5 mu kat/L).
该研究针对国外及波兰生产的111批人免疫球蛋白制剂(81批静脉用制剂,30批肌内用制剂)展开。采用发色底物法鉴定激肽释放酶(KK)和前激肽释放酶激活剂(PKA)活性。用双向免疫扩散法检测S - 2302和蛋白酶抑制剂。还应用了多种生化、生物学和血清学方法,这些方法对静脉和肌内免疫球蛋白制剂的质量控制有效。结果发现,静脉用人免疫球蛋白制剂如Bioglobulina和Gamma - Venina中存在微量的PKA和KK(PKA为0.0092 - 0.0505μkat/L,KK为0 - 0.0093μkat/L)。另一方面,正常肌内用人免疫球蛋白制剂的KK和PKA水平略高,抗HBs免疫球蛋白制剂(5.50μkat/L和153.91μkat/L)以及Tetabulina制剂与其他制剂相比,这些因子的水平非常高(4.50μkat/L和316.5μkat/L)。