胰蛋白酶的纯化及质量研究

Study on purification and quality of trypsin

目的 :建立一种胰蛋白酶的纯化方法,并进行质量研究。方法 :胰蛋白酶原(粗品)经溶解、低pH孵放法灭活病毒、超滤除盐、酶原活化、亲和层析纯化、洗脱液超滤除盐、膜过滤法去除病毒和真空冷冻干燥等工序,即得胰蛋白酶。结果:所获的胰蛋白酶符合药典规定的限度要求。结论:该方法可缩短生产工时、提高成品效价和工艺稳定性,降低糜蛋白酶含量,提升了胰蛋白酶的质量和安全性。

Objective:To prepare high-purity trypsin and investigate its quality.Methods:The manufacturing process for the production of trypsin included dissolving trypsinogen(crude extract),inactivating virus by incubation at low pH value,desalinating by ultra-filtration,trypsinogen activating,purification by affinity chromatography,eluent desalinating by ultrafiltration,virus removal by nano-film filtration and vacuum freeze-drying.Results:The prepared trypsin could reach to the standard of pharmacopeia.Conclusion:The production cycle can be shortened,the potency of trypsin and the stability of the process can be improved,the content of chymotrypsin can be reduced and the quality and safety of trypsin can be increased.