Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (11): 641-645.

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Acquisition and Analysis of Basic Data of Juvenile Sprague-Dawley Rats

MU Wen-bo1, LI Hui1, AN Hui-ping1, CHENG Hong-xu1, WANG Can2, JIN Hong-tao1,2, WEI JIN-feng1,2,*   

  1. 1 Beijing Union-Genius Pharmaceutical Technology Development Co., Ltd., Beijing 100176, China;
    2 New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China
  • Received:2017-12-26 Revised:2017-12-26 Online:2017-11-20 Published:2017-12-26

Abstract: Objective To acquire and analyze the basic data of different weeks juvenile Sprague-Dawley rats and provide scientific basis for nonclinical safety evaluation of pediatric drug products. Methods The 18 biochemical indexes of Sprague-Dawley rats in different ages and sexes were measured by automatic chemistry analyzer. The results were analyzed by SPSS software. Results In the results of 3 weeks old Sprague-Dawley rats, the AST、TBIL、LDH、CK、Na showed statistical significance between male and female group (P <0.05 or P <0.01). In 8 weeks old, the ALB、ALP、UREA、TG、K showed statistical significance between male and female group (P <0.05 or P <0.01). In 11 weeks old, almost all the biochemical indexes showed statistical significance between male and female group except GLU、UA、Na、Cl (P <0.05 or P <0.01). In 20 weeks old, almost all the biochemical indexes showed statistical significance between male and female group except UREA、Na、Cl (P<0.05 or P<0.01). In 32 weeks old, almost all the biochemical indexes showed statistical significance between male and female group except UREA、TG、Na、Cl (P <0.05 or P <0.01). Conclusion The biochemical indexes of Sprague-Dawley rats exhibit difference in different ages and sexes. So, it is necessary to establish the basic data of juvenile Sprague-Dawley rats for nonclinical safety evaluation of pediatric drug products. The results of this research may provide scientific basis for nonclinical safety evaluation of pediatric drug products, and will be helpful for ensuring the safety of drug use in children.

Key words: juvenile Sprague-Dawley rat, experimental animal, basic data

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