宁悦胶囊的抗抑郁作用及安全性评价  

Antidepressant effect and safety evaluation of Ningyue capsules

作　　者：姚玉兰 程丹 李静娜 王运良 YAO Yulan;CHENG Dan;LI Jingna;WANG Yunliang(The Second Affiliated Hospital of Zhengzhou University,Zhengzhou 450003,China;Zhengzhou People's Hospital,Zhengzhou 450002,China;The 960th Hospital of Chinese People's Liberation Army,Zibo 255300,China)

机构地区：[1]郑州大学第二附属医院,河南郑州450003 [2]郑州人民医院,河南郑州450002 [3]中国人民解放军第960医院,山东淄博255300

出　　处：《中国实用神经疾病杂志》2025年第2期133-139,共7页Chinese Journal of Practical Nervous Diseases

摘　　要：目的研究宁悦胶囊的抗抑郁作用,并对其急性毒性和亚急性毒性效应进行评价,为实验室及临床用药提供理论依据。方法建立大鼠慢性温和不可预知性应激(CUMS)模型,观察宁悦胶囊对CUMS模型大鼠糖水偏好试验、旷场试验、悬尾试验等行为学的影响及HE染色海马CA1区差异。对60只小鼠单次经口灌胃给予最大浓度宁悦胶囊,给药后连续观察7 d,评价其急性毒性效应;对140只大鼠给予不同剂量宁悦胶囊,连续给药7 d,评价其亚急性毒性效应。结果给予宁悦胶囊14 d后,CUMS抑郁模型大鼠糖水偏好试验、旷场试验、悬尾试验等行为学实验结果显著改善,HE染色海马CA1区与正常组无统计学差异。安全性评价显示,宁悦胶囊的急性毒性剂量远高于药效学的起效剂量;不同剂量宁悦胶囊对大鼠体质量、血液学、生化学指标、内脏器官均无明显毒性作用,病理切片检查未见与药物作用相关的病理形态学变化。结论宁悦胶囊具有显著的抗抑郁作用及较高的安全性。Objective To study the antidepressant effect of Ningyue capsule and evaluate its acute and subacute toxic effects,so as to provide theoretical basis for laboratory and clinical medication.Methods A rat model of chronic unpredictable mild stress(CUMS)was established,and the antidepressant effect of Ningyue capsule was studied by observing the behavioral changes of CUMS rats in the sucrose preference test,open field test,tail suspension test and HE staining in the hippocampal CA1 region.Sixty mice were given a single of maximum concentration of Ningyue capsule by oral gavage,and the acute toxic effects were assessed for 7 days after administration.A total of 140 rats were given different doses of Ningyue capsule by oral gavage for 7 consecutive days to assess its subacute toxic effects.Results After 14 days of administration of Ningyue capsule,the rats with CUMS depression showed significant improvement in the sucrose preference test,open field test,tail suspension test and other behavioral tests,and there was no significant difference in the hippocampal CA1 region between the CUMS depression model rats and the normal group.The results of safety evaluation showed that the acute toxic dose of Ningyue capsule was much higher than the pharmacodynamic onset dose.Ningyue capsules at different doses had no significant toxic effects on the body weight,hematology,biochemical indexes and internal organs of rats,and no pathomorphological changes related to drug effects were observed in pathological sections.Conclusion Ningyue capsule has significant antidepressant effect and high safety.

关 键 词：宁悦胶囊 抗抑郁 急性毒性 亚急性毒性 安全性评价 大鼠 小鼠 

分 类 号：R332[医药卫生—人体生理学]