冠心宁注射液安全药理学研究

目的 观察冠心宁注射液对中枢神经系统、心血管系统和呼吸系统的影响，为临床用药提供参考。方法 采用遥测技术，研究冠心宁注射液对清醒Beagle犬血压和心电的影响；采用全身体积描记系统，研究冠心宁注射液对SD大鼠呼吸系统的影响；采用小鼠自主活动、协调运动和阈下剂量戊巴比妥钠催眠试验，研究冠心宁注射液对中枢神经系统的影响。结果 遥测试验结果显示，与溶媒对照组比较，注射用冠心宁1、2、4 mL·kg^-1三个剂量组Beagle犬给药后30 min内心率减慢，血压下降，30 min后逐渐恢复，其他心电指标无明显变化。大鼠呼吸试验结果显示，与溶媒对照组比较，冠心宁注射液4、8、16 mL·kg^-1剂量组大鼠呼吸频率、潮气量和每分通气量无明显差异。小鼠中枢神经系统试验结果显示，与溶媒对照组比较，冠心宁注射液5、10、20 mL·kg^-1剂量组小鼠药后15 min和30 min自主活动次数降低；而协调运动等级和睡眠率无明显差异。结论 冠心宁注射液可短暂降低动物血压和心率，抑制自主活动，对呼吸系统无明显影响。

Study on safety evaluation of Guanxinning Injection

Objective To study the effect of Guanxinning Injection on cardiovascular system, respiratory system and central nervous system.Methods Telemetry technology was used to study the effects of Guanxinning Injection on blood pressure and electrocardiogram(ECG) in Beagle dogs.Whole body plethysmography system was used to study the effects of Guanxinning Injection on respiration in rats. The effects on central nervous system in mice were detected by three safety pharmacological tests including the autonomic activity test, coordinated motion test and hypnotic test with subthreshold dosage of pentobarbital sodium.Results The heart rate and blood pressure of dogs dropped within 30 minutes after administration of Guanxinning injection (1,2,4 mL·kg^-1) compared with solvent control dogs. There was no difference in breathing frequency, tidal volume and ventilation volume per minute in rats between Guanxinning Injection (4,8,16 mL·kg^-1) and solvent control group. The results of mouse safety pharmacology test indicated the number of independent activities of mice decreased at 15 and 30 minutes after administration of Guanxinning Injection (5,10,20 mL·kg^-1) compared with solvent control mice. Coordination of exercise levels and sleep rate in mice administrated with Guanxinning Injection (5,10,20 mL·kg^-1) were identical to the control group.Conclusion Guanxinning Injection can temporarily reduce blood pressure and heart rate of animals and inhibit autonomous activities. There was no significant effects on respiratory system after administration of Guanxinning Injection.