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人丙种球蛋白含多种抗体,其主要成份为IgG。人丙种球蛋白(以下简称丙球)注射液具有抗菌、抗病毒及抗毒素等免疫作用,用于增加机体抵抗力、预防传染性肝炎、麻疹及治疗丙球缺乏症,是临床上常用的一种生物制剂。关于生丙球制剂的稳定性问题,不断有文章报道,由各种方法制备的丙球由于受纤维蛋白溶解酶等因素的影响,经存放后发生“自动裂解”,致使抗体效价降低,我们从制剂学角度,用加逮实验的方法、考察了重金属离子、氧化剂及温度、光线对丙球注射液稳定性的影响、
Human gamma globulin contains a variety of antibodies, the main component of IgG. Human gamma globulin (hereinafter referred to as the ball) injection with antibacterial, anti-viral and anti-toxin and other immune function, used to increase body resistance, prevention of infectious hepatitis, measles and treatment of ciliary deficiency, is a commonly used clinical Biological agents. On the stability of raw balls preparation problems, there have been articles reported that by various methods prepared by the ball due to fibrinolytic enzymes and other factors, after storage occurs “automatic lysis”, resulting in reduced antibody titer, we From the point of view of formulation, the effects of heavy metal ions, oxidant, temperature and light on the stability of ciliary injection were investigated by adding and removing experiments.