宁泌泰胶囊对大鼠的长期毒性研究

Study on Long-Term Toxicity of Extracts from Ningmitai Capsules on Rats

目的研究宁泌泰胶囊连续灌胃给药35 d对大鼠的毒性。方法将60只大鼠随机分为3组,药物组大鼠分别灌胃宁泌泰胶囊4.0 g/kg和1.5 g/kg,对照组大鼠灌胃相同体积的蒸馏水。给药(或蒸馏水)35 d后,每组处死动物数的1/2(n=10),并对其进行血液生化检测和病理解剖。停药14 d后,剩余的动物(n=10)进行恢复性实验检测。结果宁泌泰胶囊对大鼠的生长发育、造血功能和血液生化学指标均无明显的毒性,对大鼠的心、肝、脾、肺、肾、睾丸、子宫等组织的形态学检查亦未发现有明显损伤性毒性变化。结论宁泌泰胶囊长期服用毒性低,临床用药量安全。

Objective To observe the property and degree of long- term toxicity of Ningmitai and evaluate whether the toxic injure can beprevented or recovered, so as to provide the reference for clinical safe use. Methods 60 rats were randomlydivided into three groups, Ningmitai （4. 0, 1.5 g/kg） groups and control （ig same volume of distilled water） group for all being treated for 35 d, respectively. Then the rats were sacrificed 1/2（n=10） in each group and the anatomy and pathological biochemical detection were carried on. The remaining（ n = 10） were sacrificed after 14 d of withdrawal drug to use for the reversible experiment. Results There was no significance of the extract from Ningmitai Capsules on the growth/hematopoietic function/biochemical criterion of serum or the pathological feature, i. e. toxicity changes with obvious injury in heart, liver, spleen, lung, kidney, testes, and uterus. Conclusion There is very low toxicity of the extract from Ningmitai Capsule for the long-term safe use which is safe to be used in clinic.