家蚕表达人促红细胞生成素口服急性毒性和初步药效学研究

Research on Acute Oral Toxicity and Preliminary Pharmacodynamics of Human Erythropoietin Expressed in Bombyx Mori

为了研究家蚕表达的重组人促红细胞生成素(BmrhEPO)口服治疗肾性贫血的疗效并评价安全性,进行了小鼠口服BmrhEPO急性毒性实验,结果显示其对小鼠基本无毒或毒性极低,小鼠口服BmrhEPO最大耐受剂量大于147 882IU/kg。肾性贫血小鼠以剂量为62 865IU/kg和20 955IU/kg的两个剂量组连续口服BmrhEPO一周,以小鼠血液网织红细胞数及百分率为药效指标,结果显示口服有药效,并且药效与剂量呈正相关。本实验为开发重组人促红细胞生成素口服药物提供了理论指导和实验基础。

To study the therapeutic effect of oral administration of recombinant human erythropoietin（BmrhEPO）expressed in bombyx mori on the treatment of renal anemia and evaluate its security,this paper conducts an experiment on acute toxicity after oral administration of BmrhEPO of a mouse.The result shows that it is basically non-toxic for a mouse or its toxicity is extremely low.The maximum tolerance dose of a mouse for oral administration of BmrhEPO is more than 147 882IU/kg.Mice with renal anemia took BmrhEPO orally for one consecutive week with the dose of 62 865IU/kg and 20 955IU/kg.The number and percentage of blood reticulocyte of mice are used as indexes of pharmacodynamics.The result shows that oral administration has pharmacological function and pharmacological function has positive correlation with dose.This experiment provides theoretical guidance and experimental foundation for the development of recombinant human erythropoietin oral drugs.