Mozen M M, Schroeder D D, Cabasso V J
Arzneimittelforschung. 1980;30(9):1484-6.
A new immune serum globulin preparation has been developed which is suitable for i.v. administration. This product was prepared from Cohn fraction II by selective reduction with dithiothreitol of one or more of the interchain disulfide bonds between the heavy chains and subsequent alkylation of the formed sulfhydryls (about 8--10 per 160 000 daltons) with iodoacetamide. The of these chemical reactions has been termed MISG (modified immune serum globulin). It is free of anticomplement activity, contains essentially all of the antibody potency of immune serum globulin, sediments as essentially a single entity with a sedimentation coefficient of about 7 S, has been freed of all reactants, is non-toxic, and in rabbits is antigenically with normal human immune serum globulin. MISG with its Fc fragment portion intact maintains its complement mediated function as evidenced by its opsonic activity against bacteria. MISG had been tested extensively in vitro, in animals, and in humans. Half-life measurements in humans averaged 22.4 days (range 15.5--28.7 days) and efficacy was demonstrated in a 2-year crossover clinical study in which MISG was compared with normal immune serum globulin administered i.m.
已开发出一种适合静脉注射的新型免疫血清球蛋白制剂。该产品由科恩II组分制备，通过用二硫苏糖醇选择性还原重链之间的一个或多个链间二硫键，随后用碘乙酰胺对形成的巯基（每160000道尔顿约8 - 10个）进行烷基化。这些化学反应的产物被称为MISG（修饰免疫血清球蛋白）。它无抗补体活性，基本包含免疫血清球蛋白的所有抗体效价，沉降时基本为单一实体，沉降系数约为7S，已去除所有反应物，无毒，在兔体内与正常人免疫血清球蛋白具有抗原性。MISG完整的Fc片段部分保持其补体介导的功能，其对细菌的调理活性证明了这一点。MISG已在体外、动物和人体中进行了广泛测试。人体半衰期测量平均为22.4天（范围15.5 - 28.7天），在一项为期2年的交叉临床研究中证明了其疗效，该研究将MISG与肌肉注射的正常免疫血清球蛋白进行了比较。
