癌变·畸变·突变2026，Vol.38Issue(1)：59-63,78,6.DOI:10.3969/j.issn.1004-616x.2026.01.010
静脉注射重组Ⅲ型人源化胶原蛋白的一般毒理学研究
General toxicological study of intravenous recombinant humanized type Ⅲ collagen
刘欢 1陈建华 1尹晶晶 1李建华 1张天睿 1王若琪 1高洁 1李建国1
作者信息
- 1. 中国辐射防护研究院药物安全性评价中心,中国核工业集团有限公司放射毒理与放射性药物临床前评价重点实验室,药物毒理及放射性药物临床前研究山西省重点实验室,国家原子能机构核技术(放射性药物非临床评价)研发中心,山西 太原 030006
- 折叠
摘要
Abstract
OBJECTIVE:To evaluate safety of recombinant humanized Type Ⅲ collagen and to provide reference data for safe clinical use.METHODS:The maximum tolerated dose method was adopted in the acute toxicity test.ICR mice aged 3-5 weeks were administered the recombinant collagen via tail vein injection at the maximum dosage of 2 000 mg/kg for a single administration.After administration,the toxic reaction in these mice was closely observed.In the long-term toxicity test,120 SD rats aged 6 weeks were selected and divided into high-dose(130 mg/kg),medium-dose(65 mg/kg),low-dose(32.5 mg/kg)groups and a control group,with 30 rats in each group.The drug was continuously administered for 28 days,followed by a 28-day recovery period.The main inspection indicators included animal ophthalmology,body weight,feed consumption,hematological indexes,serum biochemistry,blood coagulation,urine indexes,histopathology,etc.RESULTS:In the acute toxicity test,the maximum tolerated dose was greater than 2 000 mg/kg,equivalent to 1 503.76 times the clinically proposed dosage,and no obvious toxic and side effects.In the 28-day repeated dose toxicity test,the no-observed-adverse-effect level(NOAEL)of recombinant humanized Type Ⅲ collagen administered via tail vein injection in SD rats was 130 mg/kg,corresponding to 97.74 times the proposed clinical dose for adults.CONCLUSION:Under the conditions of this experiment,recombinant type Ⅲ humanized collagen did not show obvious toxic reactions.关键词
重组Ⅲ型人源化胶原蛋白/急性毒性/长期毒性/非临床安全性评价Key words
recombinant type Ⅲ humanized collagen/acute toxicity test/long-term toxicity test/non-clinical safety evaluation分类
医药卫生引用本文复制引用
刘欢,陈建华,尹晶晶,李建华,张天睿,王若琪,高洁,李建国..静脉注射重组Ⅲ型人源化胶原蛋白的一般毒理学研究[J].癌变·畸变·突变,2026,38(1):59-63,78,6.
