脑络欣通胶囊的安全药理学研究

Study on Safety Pharmacology of Naoluo Xintong Capsules

目的观察脑络欣通胶囊对小鼠中枢神经系统及犬呼吸系统和心血管系统的影响,了解其潜在的对生理功能的不良影响,为临床试验提供依据及参考。方法脑络欣通胶囊灌胃小鼠,观察其对小鼠的一般行为、自主活动、运动协调能力的影响及其对戊巴比妥钠阈剂量和阈下剂量协同睡眠/催眠的影响;脑络欣通胶囊灌胃犬,观察其对麻醉犬呼吸频率、潮气量、血压、心率、心电图的影响。结果脑络欣通胶囊(40、20、10 g·kg^(-1))对小鼠的一般行为、自主活动、运动协调能力均无明显影响(P>0.05),与戊巴比妥钠睡眠/催眠无协同作用(P>0.05)。脑络欣通胶囊(9、4.5、2.25 g·kg^(-1))对犬呼吸频率、潮气量、血压均无明显影响(P>0.05);脑络欣通胶囊(9 g·kg^(-1))给药后15 min时犬的心率及心电图P波幅度均明显降低(P<0.05),脑络欣通胶囊(4.5 g·kg^(-1))给药后30、60、120、180 min时犬心电图T波幅度均明显抬高(P<0.05),脑络欣通胶囊(2.25 g·kg^(-1))对犬的心率及心电图均无明显影响(P>0.05)。结论脑络欣通胶囊对实验动物的中枢神经系统,心血管系统及呼吸系统均无明显影响。

Objective To observe the effects on the central nervous system of mice and the respiratory and cardiovascular system of dogs, and the potential adverse effects on physiological function of Naoluo Xintong capsules, which is intended to provide basis and reference for clinical trials.MethodsThe general behavior,autonomous activity and motor coordination ability of mice were observed after intragastric administration of Naoluo Xintong capsules. The synergistic effects of Naoluo Xintong capsules on sleep/hypnosis induced by the threshold dose and subthreshold dose of pentobarbital sodium were also observed. Naoluo Xintong capsules were given to dogs by gavage,and then the effects of Naoluo Xintong capsules on respiratory rate,tidal volume,blood pressure,heart rate and ECG in anesthetized dogs were investigated.Results Naoluo Xintongcapsules(40,20,10 g·kg^(-1))had no significant effects on the general behavior,autonomous activity,motor coordination ability of mice(P>0.05),and had no synergistic effects on sleep/hypnosis with pentobarbital sodium(P>0.05);Naoluo Xintong capsules(9,4.5,2.25 g·kg^(-1))had no significant effects on respiratory rate,tidal volume,blood pressure in dogs(P>0.05).Heart rate and P wave of ECG in dogs obviously decreased at 15 min after administration of Naoluo Xintong capsules(9 g·kg^(-1))(P<0.05). However,T wave of ECG in dogs increased significantly at 30,60,120,180 min after administration of Naoluo Xintong capsules(4.5 g·kg^(-1))(P<0.05). Naoluo Xintong capsules(2.25 g·kg^(-1))had no significant effects on heart rate and ECG in dogs(P>0.05).Conculsion Naoluo Xintongcapsules had no obvious effects on the central nervous system,cardiovascular system and respiratory system of experimental animals.