中国药物警戒 ›› 2017, Vol. 14 ›› Issue (11): 641-645.

• 儿童用药非临床安全性评价专栏 •    下一篇

幼年SD大鼠生化指标背景数据的建立和结果分析

牟文波1, 李慧1, 安会苹1, 程红旭1, 王灿2, 靳洪涛1,2, 魏金锋1,2*   

  1. 1 北京协和建昊医药技术开发有限责任公司,北京 100176;
    2 中国医学科学院药物研究所新药安全评价研究中心,北京 100050
  • 收稿日期:2017-12-26 修回日期:2017-12-26 出版日期:2017-11-20 发布日期:2017-12-26
  • 通讯作者: *魏金锋,男,副研究员,药物安全性评价。E-mail：weijinfeng@ugcro.com
  • 作者简介:牟文波,女,检验师,生化检验。
  • 基金资助:
    重大新药创制专项支持基金（2013ZX09302302）：医科院国际标准药物安全性评价技术平台建设; （2012ZX09301002-001-009）：药物安全性评价

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

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摘要： 目的 建立幼年SD大鼠生化指标的背景数据,并对不同周龄SD大鼠生化结果进行对比分析,为非临床研究提供各年龄段SD大鼠生化指标的背景数据。方法 采用全自动生化分析仪,对不同性别、不同周龄（幼年期：3周龄,青春期：8、11周龄,成年期：20、32周龄）SPF级SD大鼠的18项生化指标进行测定,并用SPSS统计学软件对各项生化数据进行比较分析。结果 应用统计分析,取得不同性别、不同周龄的SD大鼠生化指标正常参考值的平均值及标准差。3周龄SD大鼠生化结果AST、TBIL、LDH、CK、Na指标雌雄比较有显著性差异（P <0.05或P <0.01）;8周龄SD大鼠生化结果ALB、ALP、UREA、TG、K指标雌雄比较有显著性差异（P <0.05或P <0.01）;11周龄SD大鼠生化结果除GLU、UA、Na、Cl 外,其余生化指标雌雄比较均有显著性差异（P <0.05或P <0.01）;20周龄SD大鼠生化结果除UREA、Na、Cl外,其余生化指标雌雄比较均有显著性差异（P <0.05或P <0.01）;32周龄SD大鼠生化结果除UREA、TG、Na、Cl外,其余生化指标雌雄比较均有显著性差异（P <0.05或P <0.01）。结论 不同性别、不同周龄SD大鼠大多数生化指标的结果差异明显,因此在药物非临床安全性评价中,建立不同性别、不同周龄的SD大鼠生化正常参考值是十分必要的。幼年SD大鼠生化指标背景数据的建立是儿童用药物非临床安全性评价的重要积累和评价基础,可以为儿童用药物非临床安全性评价提供科学参考。

关键词: 幼年SD大鼠, 实验动物, 背景数据

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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