论文部分内容阅读
目的 研究热原不合格的抗人淋巴细胞免疫球蛋白（ALG）半成品再制的条件。方法 将热原不合格的ALG半成品通过碱、酸以及DEAE Sephadex A-50处理,并检测其热原和质量的变化。结果 经处理后,细菌内毒素的含量明显降低,用家兔法和鲎试剂法检测热原均合格,制品的免疫效价仍不低于1:4000,并且其他各项主要指标也均达到2000年版《中国生物制品规程》的要求。结论 这种处理方法能有效地除去ALG制品中的热原。
Objective To study the conditions for the re-production of semi-finished anti-human lymphocyte immunoglobulin (ALG) unqualified pyrogen. Methods The pyrogen-deficient ALG semi-finished products were treated with alkali, acid and DEAE Sephadex A-50, and their pyrogens and their quality were tested. Results After treatment, the content of bacterial endotoxin was significantly reduced. All samples were tested for pyrogen by the rabbit method and the 鲎 reagent method. The immune titer of the product was still not lower than 1: 4000, and the other major indexes reached 2000 Annual “Chinese Biological Products Regulations” requirements. Conclusion This method of treatment can effectively remove pyrogen in ALG products.