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Volume 33 Issue 3
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2015  >  33(3): 231-234

DAI Xiaoyu, ZHU Hai, ZHANG Xiaodong, ZHANG Xiaofang, ZONG Ying, DAI Yimin, ZHANG Shuying, YUAN Bojun, LU Guocai. Repeat-dose toxicity study of fibrin sealant in SD rats[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(3): 231-234. doi: 10.3969/j.issn.1006-0111.2015.03.010
Citation: DAI Xiaoyu, ZHU Hai, ZHANG Xiaodong, ZHANG Xiaofang, ZONG Ying, DAI Yimin, ZHANG Shuying, YUAN Bojun, LU Guocai. Repeat-dose toxicity study of fibrin sealant in SD rats[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(3): 231-234. doi: 10.3969/j.issn.1006-0111.2015.03.010
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Repeat-dose toxicity study of fibrin sealant in SD rats

doi: 10.3969/j.issn.1006-0111.2015.03.010

  • Center for New Drug Evaluation, Second Military Medical University, Shanghai 200433, China

  • Received Date: 2014-08-27
  • Rev Recd Date: 2014-12-30
  • 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 intraperitoneally injected with vehicle or FS daily for 14 days followed by a 28-day recovery period. The clinical signs, hematological 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 tendency 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 toxicity dose is 171.0 mg/kg. The target toxicity systems or site of FS in SD rats are hematological system, immune system and injection site. The toxic effects of FS are reversible.
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    [3] 谢钧韬,叶建宇,尹耀新,等.纤维蛋白封闭剂在腹腔镜胆囊切除术右副肝管处理中的应用[J].中华腔镜外科杂志(电子版),2010,3(2):205-207.
    [4] Mao Y, Xia ZN, Zhang XF,et al.Evaluation of subchronic toxicity of SIM010603,a potent inhibitor of receptor tyrosine kinase,after 28-day repeated oral administration in SD rats and beagle dogs[J].Food Chem Toxicol,2012,50(5):1256-1270.
    [5] Gong XL, Gao TT, Zhao LJ,et al.Subchronic safety evaluation of CMS-1 (a botanical antihypertensive product derived from Semen Cnidium monnieri)in Sprague-Dawley rats and beagle dogs[J].Regul Toxicol Pharmacol,2014,69(3):558-571.
    [6] 王春仁,王召旭,宋谊萍,等.医用纤维蛋白胶亚急性毒性实验研究[J].中国药事杂志,2007,21(7):472-477.
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Repeat-dose toxicity study of fibrin sealant in SD rats

doi: 10.3969/j.issn.1006-0111.2015.03.010
  • Center for New Drug Evaluation, Second Military Medical University, Shanghai 200433, China
  • Received Date: 2014-08-27
  • Rev Recd Date: 2014-12-30

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 intraperitoneally injected with vehicle or FS daily for 14 days followed by a 28-day recovery period. The clinical signs, hematological 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 tendency 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 toxicity dose is 171.0 mg/kg. The target toxicity systems or site of FS in SD rats are hematological system, immune system and injection site. The toxic effects of FS are reversible.

DAI Xiaoyu, ZHU Hai, ZHANG Xiaodong, ZHANG Xiaofang, ZONG Ying, DAI Yimin, ZHANG Shuying, YUAN Bojun, LU Guocai. Repeat-dose toxicity study of fibrin sealant in SD rats[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(3): 231-234. doi: 10.3969/j.issn.1006-0111.2015.03.010
Citation: DAI Xiaoyu, ZHU Hai, ZHANG Xiaodong, ZHANG Xiaofang, ZONG Ying, DAI Yimin, ZHANG Shuying, YUAN Bojun, LU Guocai. Repeat-dose toxicity study of fibrin sealant in SD rats[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(3): 231-234. doi: 10.3969/j.issn.1006-0111.2015.03.010
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