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目的研究该转基因羊奶表达的重组人溶菌酶的急性毒性和过敏性,确保食品质量安全。方法通过小鼠经口急性毒性、体外模拟胃肠道消化和体外热稳定性试验进行研究。结果小鼠经口急性毒性试验结果显示,重组人溶菌酶对小鼠最大耐受剂量>5000 mg/kg.BW.,属实际无毒。体外模拟胃肠道消化试验结果显示,重组人溶菌酶在模拟胃液中2~30min内全部消化;在模拟肠液中15 s~2min内全部消化:体外热稳定性试验结果显示,重组人溶菌酶在100℃加热60 min不会降解。结论该重组人溶菌酶的毒性与过敏性风险较低,可以安全应用于食品行业。
Objective To study the acute toxicity and allergy of recombinant human lysozyme expressed in the transgenic goat milk to ensure the quality and safety of food. Methods The mice were subjected to oral acute toxicity, gastrointestinal digestion and in vitro thermal stability test. Results The results of oral acute toxicity test in mice showed that the maximum tolerated dose of recombinant human lysozyme was> 5000 mg / kg.BW in mice, which is actually non-toxic. In vitro gastrointestinal digestion test results showed that the recombinant human lysozyme in the simulated gastric juice within 2 ~ 30min all digestion; simulated intestinal fluid within 15 ~ 2min all digestion: in vitro thermal stability test results showed that recombinant human lysozyme in 100 ℃ heated 60 min will not be degraded. Conclusion The recombinant human lysozyme has a low risk of toxicity and allergy and can be safely used in the food industry.