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| 抗淋巴细胞免疫球蛋白制品中热原处理 |
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艾智武1,2,叶林柏1,2,康光明1,3
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1. 武汉大学生命科学学,武汉,430072;武汉生物制品研究所,武汉,430060;2. 武汉大学生命科学学,武汉,430072;3. 武汉生物制品研究所,武汉,430060
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| 摘要: |
| 对热原不合格的抗淋巴细胞免疫球蛋白(ALG)半制品再制条件进行了研究.将高热原的ALG半制品通过使用碱、酸以及A50处理后,细菌内毒素的含量明显降低,热原质经家兔和鲎试剂检测均合格,其生物学效价仍不低于1:4000,而且它们的其它各项主要指标也都达到中国生物制品暂行规程的要求.这一试验结果表明碱、酸处理并辅以A50吸附是去除ALG制品中热原的一种有效方法. |
| 关键词: ALG 热原质 免疫效价 |
| DOI： |
| 分类号:R392 |
| 基金项目: |
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| Treatment of Pyrogen in Anti-Lymphocyte Immunoglobulin |
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| Abstract: |
| The reproductive conditions of anti-lymphocyte immunoglobulin(ALG) semi-finished product unqualified in pyrogen were studied. The content of bacterial endotoxin obviously decreased when the semi-finished products in high pyrogen were treated with HCl, NaOH and A50. The pyrogen of ALG semi-finished product reached the Requirement Standard by the Rabbit test and Limulus Amebocyte Lysate(LAL) test. Its biological activity still kept at a level of ≥1:4000 after treatment. The result showed that the treatment was an effective method to eliminate pyrogen of ALG. |
| Key words: anti-lymphocyte immunoglobulin pyrogen biological activity |
