Sato H, Kidaka T, Hori M
Int J Artif Organs. 1986 Mar;9(2):131-6.
The application of ionizing radiation (gamma-rays from 60Co) to sterilize therapeutic immunoadsorbents (IA)s was investigated. The IAs were porous bead carriers immobilizing anti-IgE antibodies and were irradiated in both the freeze-dried and precipitated (wet) states. The IgE removal (%), the IgE adsorption capacity of IA, was acceptable in terms of practical use even after an irradiation dose of 2.5 Mrad in the precipitated state; the anti-IgE antibody itself lost much of its activity, possibly because of intermolecular crosslinking of antibody molecules, after being irradiated with a dose at least of 0.5 Mrad. In the freeze-dried state only IA consisting of CPG-1400 could tolerate a dose of 2.5 Mrad. Dose-survival curves were obtained using Bacillus pumilus spores in both the freeze-dried and precipitated IAs and the D-values were calculated to be respectively 0.27 and 0.31 Mrad. Thus, ionizing radiation may be applicable for sterilizing IAs in the precipitated state and in the freeze-dried state for an IA consisting of CPG-1400 although the initial bioburden on IA should be low.
研究了电离辐射（来自60Co的γ射线）在治疗性免疫吸附剂（IA）灭菌中的应用。这些IA是固定有抗IgE抗体的多孔珠载体，并在冻干状态和沉淀（湿）状态下进行辐照。即使在沉淀状态下接受2.5兆拉德的辐照剂量后，IA的IgE去除率（%），即IA的IgE吸附能力，在实际应用中也是可以接受的；在用至少0.5兆拉德的剂量辐照后，抗IgE抗体本身失去了大部分活性，这可能是由于抗体分子的分子间交联所致。在冻干状态下，只有由CPG - 1400组成的IA能够耐受2.5兆拉德的剂量。使用短小芽孢杆菌孢子在冻干和沉淀的IA中获得了剂量存活曲线，计算出的D值分别为0.27和0.31兆拉德。因此，电离辐射可用于对由CPG - 1400组成的IA在沉淀状态和冻干状态下进行灭菌，尽管IA上的初始生物负荷应该较低。
