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健脾止泻宁颗粒的长期毒性研究

Study on the Long-term Toxicity of Jianpizhixiening Granule
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摘要 目的:考察健脾止泻宁颗粒(简称JPZX)对大鼠的长期毒性,为其临床安全使用提供实验依据。方法:实验设4组,JPZX高、中、低剂量组分别按187.1 g生药/(kg·d)、119.3 g生药/(kg·d)、51.07 g生药/(kg·d)组,相当于临床拟用量55倍、35倍、15倍,及空白对照组。连续给药92 d及停药14 d,分别检测各组大鼠的一般状况、体质量、血常规、血液生化指标,并对大鼠脏器进行系统观察和组织病理学检查。结果:各剂量组大鼠给药期及恢复期一般状况、血液学、血生化、脏器重量及系数、大体解剖观察与组织病理学检查均未见明显异常改变。结论:JPZX无明显的长期毒性,未发现毒性靶器官,在临床剂量55倍以下有较好的安全性,按临床拟用剂量服用是安全的。 Objective: To observe the long-term toxiciy t of Jianpizhixiening granule (JPZX) on rats to provide a scientific experimental basis for clinical treatment.Methods: The rats were randomly divided into four groups: a high, medium and low dose group of JPZX with 187.1, 119.3, 51.07 g crude drug ·kg^-1·day^-1 respectively, equal to 55, 35 and 15 times of clinic dose, and a control group.Parameters were examined, including general condition, body weight, the indexes of hematology, blood biochemistry and the related organ histopathology after successive administration of 92 days and 14 days′ recovery.Results: In each group, there was no significant changes in the outer appearance and behavior, the indexes of hematology, blood biochemistry, organ weight and coefficient, gross anatomical observation and histopathological examination.Conclusion: In the 55 times of clinical dose, JPZX has no significant long-term toxicity, no toxicity target organ and is relatively safe under clinical proposed dose.
出处 《世界中医药》 CAS 2017年第5期1154-1160,共7页 World Chinese Medicine
基金 重庆市科学技术委员会科技计划项目(编号:cstc2011ggC10003-37)--健脾止泻宁颗粒药理药效再评价研究
关键词 健脾止泻宁颗粒 大鼠 长期毒性 Jianpizhixiening granule Long-term toxicity Rats
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