生地百合西洋参胶囊对小鼠睡眠的促进作用及其安全性研究  

Study on the Sleep-Improving Effect and Safety of Rehmannia glutinosa Lily and American Ginseng Capsules in Mice

作　　者：赵雨杰 傅容湛[1] 郭佳琦 朱晨辉[1] ZHAO Yujie;FU Rongzhan;GUO Jiaqi;ZHU Chenhui(Biotech and Biomed Research Institute,School of Chemical Engineering,Northwestern University,Xi'an 710069,China;Shaanxi Medical Device Quality Institute,Xianyang 712046,China)

机构地区：[1]西北大学化工学院西北大学生物医药研究院,陕西西安710069 [2]陕西省医疗器械质量检验院,陕西咸阳712046

出　　处：《中国兽医杂志》2024年第4期124-129,共6页Chinese Journal of Veterinary Medicine

基　　金：“十三五”国家重点研发计划重点专项(2021YFC2101500)。

摘　　要：为了研究生地百合西洋参胶囊对小鼠睡眠的作用并对其毒理安全性进行评价,本试验以低[200 mg/(kg·bw)]、中[400 mg/(kg·bw)]、高[800 mg/(kg·bw)]剂量的生地百合西洋参胶囊连续给小鼠灌胃30 d,通过直接诱导睡眠试验、延长戊巴比妥钠睡眠时间试验、戊巴比妥钠阈下剂量催眠试验,以及小鼠脑组织中5羟色胺(5-HT)、γ-氨基丁酸(GABA)和多巴胺(DA)含量的检测,分析其改善睡眠的作用;以最大给药剂量试验(MTD)进行生地百合西洋参胶囊的小鼠急性毒性试验;以低[1 g/(kg·bw)]、中[2 g/(kg·bw)]、高[4 g/(kg·bw)]剂量的生地百合西洋参胶囊给大鼠连续灌胃30 d,评价其对大鼠的毒理安全性。结果显示,与对照组相比,生地百合西洋参胶囊对小鼠无直接诱导睡眠作用,不同剂量的生地百合西洋参胶囊均能显著延长小鼠的戊巴比妥钠睡眠时间(P<0.05或P<0.01),中、高剂量组小鼠的催眠入睡率显著提高(P<0.05或P<0.01),小鼠脑组织中5-HT和GABA的含量显著增加(P<0.05或P<0.01),高剂量组小鼠脑组织中DA的含量显著降低(P<0.05);以15 g/(kg·bw)剂量给小鼠灌胃生地百合西洋参胶囊14 d,小鼠均未出现死亡和中毒现象。大鼠在30 d喂养试验期间生长状况良好,各剂量组大鼠的体重增长量、进食量、食物利用率、血常规、血液生化和脏器系数等指标均与对照组无显著性差异(P>0.05)。结果表明,生地百合西洋参胶囊具有改善小鼠睡眠的作用,其作用机制与对小鼠脑组织中5-HT、GABA和DA含量的调节有关,本试验所用剂量范围对大鼠和小鼠均无明显毒性,安全性良好。本试验结果可为生地百合西洋参胶囊的临床应用提供参考依据。In order to study the effect of Rehmannia glutinosa lily and American ginseng capsules on mouse sleep and evaluate their toxicological safety,mice were orally gavaged with low[200 mg/(kg·bw)],medium[400 mg/(kg·bw)],and high[800 mg/(kg·bw)]doses of Rehmannia glutinosa lily and American ginseng capsules continuously for 30 days.The direct sleep induction test,prolongation of pentobarbital sodium sleep time test,subthreshold dose hypnosis test of pentobarbital sodium,and detection of serotonin(5-HT),γ-aminobutyric acid(GABA),and dopamine(DA)levels in mouse brain tissue were conducted to analyze their sleep improvement effects.The maximum tolerated dose(MTD)test was performed for acute toxicity of Rehmannia glutinosa lily and American ginseng capsules in mice.Rats were orally gavaged with low[1 g/(kg·bw)],medium[2 g/(kg·bw)],and high[4 g/(kg·bw)]doses of Rehmannia glutinosa lily and American ginseng capsules continuously for 30 days to evaluate their toxicological safety in rats.The results showed that compared with the Control group,Rehmannia glutinosa lily and American ginseng capsules did not directly induce sleep in mice,but different doses of Rehmannia glutinosa lily and American ginseng capsules could significantly prolonged the pentobarbital sodium sleep time of mice(P<0.05 or P<0.01).The hypnotic sleep rate of mice,the content of 5-HT and GABA in mouse brain tissue increased significantly(P<0.05 or P<0.01)in Middle-and High-dose group, while the content of DA in the High-dose groupdecreased significantly ( P <0.05). Mice orally gavaged with Rehmannia glutinosa lily and American ginseng capsules at a dose of 15 g/(kg·bw) for 14 days did not exhibit any deaths or signs of toxicity. Rats showed good growth status during the 30-day feeding trial, and there were no significant differences in body weight gain, food intake, food utilization rate, blood routine, blood biochemical indicators, and organ coefficients between the Dose groups and the Control group ( P >0.05). The results indicate that Rehmannia gl

关 键 词：生地黄提取物 百合提取物 西洋参提取物 胶囊 改善睡眠 安全性 

分 类 号：R971.3[医药卫生—药品]