α_1-抗胰蛋白酶的制备及其防治急性肺损伤的疗效

目的　以FIV 1为原料 ,制备较高纯度α1 AT制剂 ,用该制剂干预急性肺损伤动物模型作疗效考核。方法　FIV 1抽提液经PEG沉淀 ,离子交换 ,病毒灭活、超滤、除菌、分装 ,冻干制备α1 AT制剂。用急性肺损伤动物模型 ,比较静脉注射与雾化吸入α1 AT的治疗效果。结果　 3批制剂纯度 >70 % ,无菌、热原、安全试验均符合生物制品规程要求。静脉注射或雾化吸入 ,可降低由内毒素诱发急性肺损伤程度。结论　α1 AT制备工艺适合大规模生产。在防治急性肺损伤时有一定效果

Curative Effect of α1-antitrypsin(α1-AT) on Acute Lung Lesion Caused by Endotoxin in Animal Model

Objective To prepare highly purified α 1 antitrypsin(α 1 AT) from FIV 1 and evaluate its curative effect on the acute lung lesion caused by endotoxin in animal model.Methods Extract α 1 AT from FIV 1,precipitate with PEG,purify by ion exchange chromatography and lyophilize.Establish rabbit model of acute lung lesion caused by endotoxin,and compare the curative effects of α 1 AT by intravenous injection and aerosol inhalation.Results All the 3 batches of α 1 AT showed purities of above 70%,and were qualified in sterility,pyrogen and safety tests.The preparation,both by intravenous injection and aerosol inhalation,eased the lung lesion caused by endotoxin.Conclusion The developed procedure is suitable for the large scale production of α 1-AT,and the prepared α 1 AT showed a certain curative effect on acute lung lesion.