中国药物警戒 ›› 2011, Vol. 8 ›› Issue (11): 641-644.

• 基础及临床研究 •    下一篇

蟾砂胶囊急性与长期毒性研究

刘海霞, 赵健, 徐凌川*, 李自发   

  1. 山东中医药大学,山东 济南 250355
  • 收稿日期:2011-05-28 出版日期:2011-11-10 发布日期:2015-07-30
  • 通讯作者: 徐凌川,教授,硕士研究生导师,中药质量控制研究。E-mail:xulingchuan518@sina.com
  • 作者简介:刘海霞,女,硕士研究生在读,中药质量控制研究。

Study of Acute and Long-term Toxicity of Chansha Capsules

LIU Hai-xia, ZHAO Jian, XU Ling-chuan*, LI Zi-fa   

  1. Shandong University of Traditional Chinese Medicine, Shandong Jinan 250355, China
  • Received:2011-05-28 Online:2011-11-10 Published:2015-07-30

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摘要： 目的 探讨蟾砂胶囊单次或多次给药后,动物出现的毒性反应及其性质和程度,为临床安全用药提供毒理学依据。方法 急性毒性实验采用小鼠灌胃给予蟾砂胶囊浸膏10.8 g/kg体重（分2次）,观察14d;长期毒性实验采用大鼠连续以蟾砂胶囊19.98g/kg、9.99g/kg、2.00g/kg 体重,灌胃给药180 d,停药30d,观察其雌雄大鼠体重、食量及粪便等一般临床体征,检测血液学指标、血液生化指标、脏器指数,并对主要器官和组织进行了病理学观察。结果 小鼠灌胃最大耐受量为45.8g 生药/kg,相当临床用量的92.3倍。长期毒性试验中,中、高剂量组对血液学指标,高剂量组对血液生化学指标、脏器重量绝对值、脏器指数等出现一定的影响,部分指标有显著差异（P<0.01）,脏器肉眼观察及病理学检查可见肝脏和肾脏有病理改变。停药恢复30 d后,大鼠体重、摄食量、活动、血液学、生化指标检查、脏器重量系数、病理学检查均正常。结论 蟾砂胶囊在说明书推荐剂量下服用是安全可靠的。

关键词: 蟾砂胶囊, 急性毒性, 长期毒性

Abstract: Objective To observe acute toxicity in mice and long-term toxicity in rat of Chansha Capsules. Methods Given the extract of Chansha Capsules 10.8g/kg to the rats for 14 days, and calculated the maximum administration dosage. In the long-term toxicity test, rats were continuously fed with Chansha capsule at 19.98g/kg,9,99g/kg and 2.00g/kg a day for 180 days, and 30 days of stopping treatment, observe the male and female rats weight and appetite and feces, general clinical signs, the indication of hematology and blood biochemical analysis, organs coefficient, and the major organs and tissues observed the pathology. Results The maximum administration dosage of Chansha Capsules by ig administration was 45.8g/L in mice(equal to 92.3 times of clinical dose). In the chronic toxicity tests, blood biochemical analysis, organs weight absolute value and coefficient of organs in high-dose group exist significant differences, meanwhile, the indication of hematology significantly differ in both medium and high dose groups. The changes of weight, food intake, activities, the indication of hematology and blood biochemical analysis, organs coefficient and histopathology could completely recover in 30 days after stopping the drug. Conclusion Chansha Capsules administration by long-period might slightly injure the renal and liver function of rats, but the injury was reversible. It is safe to administer the prescribed dose of Chansha Capsules.

Key words: Chansha Capsules, acute toxicity, long-term toxicity

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