Repeat-dose toxicity study of fibrin sealant in SD rats
10.3969/j.issn.1006-0111.2015.03.010
- VernacularTitle:纤维蛋白封闭剂对SD大鼠连续腹腔注射给药14天的毒性研究
- Author:
Xiaoyu DAI
1
;
Hai ZHU
;
Xiaodong ZHANG
;
Xiaofang ZHANG
;
Ying ZONG
;
Yimin DAI
;
Shuying ZHANG
;
Bojun YUAN
;
Guocai LU
Author Information
1. 第二军医大学药物安全性评价中心
- Keywords:
fibrin sealant;
SD rats;
repeat-dose toxicity;
preclinical safety
- From:
Journal of Pharmaceutical Practice
2015;(3):231-234
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety of fibrin sealant (FS) intraperitoneal injection in SD rats .Methods 80 male and female SD rats were randomly divided into four groups (0 ,85.5 ,171 .0 ,342 .0 mg/kg) by body weight .All rats were in-traperitoneally injected with vehicle or FS daily for 14 days followed by a 28-day recovery period .The clinical signs ,hematolog-ical and biochemical indices were measured .The pathology were observed .Results Increase of white blood cell count (WBC) and decrease of fibrinogen (FIB) in d 14 were found in 171 .0 mg/kg and 342 .0 mg/kg dosage groups .Furthermore ,the tend-ency of weight increase of spleen were found in 171 .0 mg/kg and 342 .0 mg/kg dosage groups .Pathological exams of peritoneal cavity found that there were granulation tissues containing FS in some of the rats in 342 .0 mg/kg group .All of these changes got reversed after the recovery period .Conclusion The safety dose in this study is considered to be 85.5 mg/kg ,and the toxic-ity dose is 171 .0 mg/kg .The target toxicity systems or site of FS in SD rats are hematological system ,immune system and in-jection site .The toxic effects of FS are reversible .
