中国药物警戒 ›› 2014, Vol. 11 ›› Issue (2): 65-69.

• 基础研究 •    下一篇

参丹芎注射液对大鼠长期毒性实验研究

吴虓飞, 胡宇驰*, 曹春然, 孙圆媛, 吕晶   

  1. 北京市药品检验所药物安全评价中心,北京 100035
  • 收稿日期:2013-08-15 修回日期:2016-02-03 出版日期:2014-02-08 发布日期:2016-02-03
  • 通讯作者: 胡宇驰,男,硕士,副主任药师,药物安全评价。
  • 作者简介:吴 虓飞,男,博士,主管药师,药物安全评价。
  • 基金资助:
    基金项目：国家创新药物资助项目（No.2009ZX09103-445）

Experimental Study on the Long-term Toxicity of Shendanxiong Injection in Rats

WU Xiao-fei, HU Yu-chi*, CAO Chun-ran, SUN Yuan-yuan, LV Jing   

  1. Drug Safety Evaluation Center, Beijing Institute for Drug Control, Beijing 100035, China
  • Received:2013-08-15 Revised:2016-02-03 Online:2014-02-08 Published:2016-02-03

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摘要： 目的研究连续静脉给予参丹芎注射液对SD大鼠产生的毒性反应。方法参丹芎注射液342、228、152mg生药·kg-1（高、中、低剂量）连续尾静脉注射给药30天,整个实验期间观察动物的一般状态、测定体重和摄食量,分别于给药30天及停药后14天取部分大鼠进行血液学指标、血清生化学指标、脏器系数和病理组织学检查。结果大鼠未发生因给药而引起的异常症状,各给药组大鼠体重增长和摄食正常。与阴性对照组比较,在给药30天时,高剂量组导致大鼠WBC、GR%、Urea、CR、TBIL和肝脏系数、肾脏系数、肾上腺系数明显增高,中剂量组GR%、CR、TBIL显著增高和LY%显著降低（P <0.05）,停药恢复14天后,除CR和肾系数之外,高剂量组其他指标均恢复正常,中剂量组所有指标恢复正常。高剂量组大鼠肾脏组织出现不可逆性病变,中剂量组大鼠肾脏组织出现可逆性病变。结论中剂量静脉注射参丹芎注射液30天,可导致SD大鼠出现肾脏功能及病理组织学可逆性改变。

关键词: 参丹芎注射液, 长期毒性, 大鼠

Abstract: ObjectiveTo observe the long-term toxicity of shendanxiong injection in rats by intravenous injection. MethodsDaily doses of shendanxiong injection at 342、228、152 mg crude drug·kg-1 for 30 days were used for high, mid, and low dose group, respectively. Clinical observations, examinations of body weight and feed consumption were performed during whole experimental stage. Rats examinations including haematological indexes, biochemical indexes, organ coefficient, and histopathology were performed on the 30th day, and on the 14th day after withdrawal, respectively. ResultsNo abnormity was found in all rats in terms of clinical observation, body weight increase and food consumption. The levels of WBC, GR%, Urea, CR, TBIL and liver coefficient, kidney coefficient, adrenal gland coefficient in high dose group were significantly higher than those in control group, and the levels of GR%, CR, TBIL in mid dose group were significantly higher than those in control group, and LY% level in mid dose group was significantly lower than those in control group on 30th day (P<0.05). Those changed indexes of hematology, blood biochemistry and organ coefficient in high dose group regained normal except CR level and kidney coefficient on the 14th day after withdrawal, and above indexes in mid dose group all regained normal. The kidney of rats in high dose group appeared irreversible pathological changes, but the kidney of rats in mid dose group appeared reversible pathological changes. ConclusionRepeated intravenous injection administration of the shendanxiong injection at mid dose could lead to reversible damage to kidney function and pathology

Key words: shendanxiong injection, long-term toxicity, rat

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