黑龙江八一农垦大学学报Issue(1):29-32,4.DOI:10.3969/j.issn.1002-2090.2015.01.007
牛乳溶菌酶的安全性评价
Safety Evaluation of Bos taurus Lysozyme
摘要
Abstract
The purpose of the study was to carry out the safety evaluation of laboratory preparation of bos taurus lysozyme 1 (LYZ-1) powder before the clinical trials. Through the antibacterial test,the inhibitory concentration of LYZ-1 would be determined. Through the solution hemolysis test of LYZ-1,LYZ-1 solution suspension mixing with 2% rabbit red blood cell would be observed whether there was hemolysis phenomenon;after the subject contrast of the LYZ-1 solution on rabbit eye drops,the changes would be observed to determine the ocular mucosa irritation of the drug before and after different time points. The test results showed that inhibitory concentration of LYZ-1 powder was 4 mg·mL -1,and LYZ-1 had no hematolysis and agglutination and had small stimulation to ocular mucosa after 6 hours,while stimulation would disappear after 48 hours. Thus,LYZ-1 formulation had the security and was conformed to the local standard of mucosal part,and could be applied in clinical trials.关键词
牛乳溶菌酶/溶血试验/刺激性试验Key words
LYZ-1/hemolysis test/irritation test分类
农业科技引用本文复制引用
张璐莹,罗春海,许启有,李诗莹,邹晓,付世新..牛乳溶菌酶的安全性评价[J].黑龙江八一农垦大学学报,2015,(1):29-32,4.基金项目
黑龙江农垦总局攻关项目(HNK11A-08-01-08)。 ()