新生牛肝活性肽的制备及其毒性检测

目的制备新生牛肝活性肽并评价其安全性。方法采用膜法分离制备新生牛肝活性肽。将3批制品于37～40℃,75%相对湿度条件下存放3个月,以多肽含量为指标观察其稳定性,并进行急性毒性试验、小鼠骨髓细胞微核试验、Ames试验、小鼠精子畸形试验和大鼠喂养试验。结果制备的3批新生牛肝活性肽存放3个月后,多肽含量无明显下降,质量稳定。小鼠和大鼠经口灌人大于20.0g/kg体重的新生牛肝活性肽,均无急性毒性。3种致突变试验均未显示出致突变性,大鼠喂养试验各项指标均未见明显毒性。结论新生牛肝活性肽未表现出明显毒性。

Preparation and Toxicity of Newborn Bovine Hepatic Active Peptide

Objective To evaluate the safety of newborn bovine hepatic active peptide.Methods Prepare newborn bovine hepatic active peptide by membrane separation and store at 37-40℃and a relative humidity of 75% for 3 months,then observe for sta- bility and perform acute toxicity test in both mice and rats,born marrow micronucleus test in mice,Ames test and sperm deform test in mice as well as feeding test in rats.Results After storage for 3 months,the polypeptide content of prepared newborn bovine hepatic acctive peptide showed no significant decrease,indicating good stability.The active peptide showed no acute toxicity or mutagenicity, and all the physiological indexes of rats fed were normal.Conclusion Newborn bovine hepatic active peptide showed no significant toxicity.