健脾止泻宁颗粒的长期毒性研究

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。

Study on the Long-term Toxicity of Jianpizhixiening Granule

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.