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目的:骆驼刺胶囊剂为骆驼刺单味药材提取物制备,观察骆驼刺提取物连续灌胃给药13周对大鼠产生的毒性反应。方法:骆驼刺提取物分别以3.0,1.0,0.3 g/kg灌胃给药,每周给药6 d,试验周期为13周,各试验组剩余的1/3动物观察2周恢复期变化。按中药新药长期毒性试验要求观察动物的一般状况、体重变化、血液细胞学及生化学指征、解剖及组织病理学检查。结果:各剂量药组与对照组大鼠比较,血液及生化指标与对照组相比无明显差异,脏器未出现给药相关的病变。结论:骆驼刺提取物长期灌胃3g/kg未见毒性反应。
OBJECTIVE: The camel ache capsule was prepared from a single extract of camellia herb. The toxicity of the camel’s extract to rats was observed after 13 weeks of continuous intragastric administration. METHODS: Alhagi sparsifolia extracts were orally administered at 3.0, 1.0 and 0.3 g / kg orally, respectively, for 6 days. The experimental period was 13 weeks. The remaining 1/3 of each experimental group was observed for 2 weeks convalescence. According to the long-term toxicity test of traditional Chinese medicine, we observed the general condition, weight change, hematological and biochemical indications, anatomy and histopathological examination. Results: Compared with the control group, there was no significant difference in the blood and biochemical indexes between the groups treated with each dose and the control group. There was no drug-related pathological changes in the organs. Conclusion: Long-term gavage of camel’s thorn extract showed no toxic reaction at 3g / kg.