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组织胺丙种球蛋白(human histaglobulin)系人血丙种球蛋白的抗组织胺注射液,主要成分为每1000 ml含人血丙种球蛋白6g.磷酸组织胺0.125 mg,疗效较好[1]。由于其中人血丙种球蛋白浓度较小,往往会析出沉淀。因此蛋白质在稀的水溶液中,其分子间的静电引力较大,易变性并降低溶解度所致[2]。这样不但影响外观,还会影响疗效,故此产品放置日久只允许有微量并可摇散的颗粒存在[1]。因此,提高此制剂的稳定性很有必要。 经多次实验,并长期留样观察和探索,发现在此制剂中加少量甘氨酸,会明显提高制剂在溶解度方面的稳定性,结果见附表。 附表 甘氨酸对组织胺丙种球蛋白稳定性的影响 含甘氨酸的制剂 不含甘氨酸的制剂 实验批次 50 50蛋白质析出的批数 2 17蛋白质析出率(%) 4 34由附表可知,加甘氨酸后制剂的蛋白质析出率由34%降为4%,有明显效果(P<0.01)。
Histamine gamma globulin (human histaglobulin) Department of human gamma gamma globulin antihistamine injection, the main component per 1000 ml containing human gamma globulin 6g 0. histamine histamine amine, better curative effect [1]. Due to the low concentration of human gamma globulin, precipitation tends to precipitate. Therefore, the protein in dilute aqueous solution, the larger the electrostatic attraction between molecules, volatility and reduce solubility [2]. This will not only affect the appearance, but also affect the curative effect, so the product is allowed only for a long time and can be dispersed particles can be scattered [1]. Therefore, it is necessary to improve the stability of this preparation. After many experiments and long-term observation and exploration samples, found in this preparation with a small amount of glycine, will significantly improve the stability of the preparation in terms of solubility, the results see attached. Schedule glycine on histamine gamma globulin stability Glycine-containing preparation Glycine-free preparation Experimental batch 50 50 Batch of protein precipitation 2 17 Protein precipitation rate (%) 4 34 It can be seen from the table, after the addition of glycine Preparation of protein precipitation rate from 34% to 4%, a significant effect (P <0.01).