丹参葡萄糖注射液对Beagle犬的长期毒性研究

目的　在动物体内验证丹参葡萄糖注射液 (丹参 )临床毒副反应及性质。方法　以丹参 0 .8、2 .0、5 .0 g/(kg·d)对Beagle犬连续静脉缓慢注射 15 0d及 180d ,观察用药期间毒性反应及停药 2 1d期间恢复情况。结果　丹参高剂量组用药 30～ 15 0d、中剂量组 4 5d、135d及 15 0d动物体重增长明显减慢 (P <0 .0 1,P <0 .0 5 ) ;用药期及恢复期各组动物进食量、心电图、血液学、尿液等各项指标均在正常值范围内 ;丹参高剂量组用药 180d ,凝血时间延长 ,高、中剂量组用药 180d ,AST明显升高 ,白蛋白降低 ;高剂量组部分动物有不同程度的肝脂肪变性及肝细胞水肿 ,但停药 2 1d基本恢复正常。结论　丹参高剂量长期应用对Beagle犬肝细胞有一定毒性 ;其无毒反应剂量大约为 2 .0g/ (kg·d)

Study on a long-term toxicity test of Danshen glucose injection in Beagle dog

ObjectiveIn order to verify the clinical poisonous side reaction and property of Danshen Glucose Injection (DGI) by administering intravenous injection in animals,a long-term toxicity test was made with a duration of 180 days.MethodThe Beagle dog was administered intravenously with divided dose of DGI 0.8,2.0,5.0 g/(kg·d) with progressive slow injection of 150 d and 180 d.Both of the courses of injection and withdrawal were observed for detecting the side reaction and rehabilitation in 21 d respectively.ResultsAmong the high dosage group5.0 g/(kg·d),with a duration of 30～150 d]and medium dosage group2.0 g/(kg·d),with a duration of 45 d,135 d and 150 d],animal weight increase slowed down obviously(P<0.01,P<0.05).During the period of injection and rehabilitation,the indexes such as food-intake measurement,cardiogram examination,hematology test and urinalysis were within the scope of normal value.Delayed coagulation time was measured in high DGI dosage group,increased AST and reduced albumin were observed in both high and medium dosage group,with a duration of 180 d.Some animals in high dosage group demonstrated fatty degeneration of liver and liver cell edema,but the condition reversed after the withdrawal of 21 d.ConclusionThe results suggest that long-term administering high DGI dosage can be toxic to Beagle dog liver cells.The safe dosage should be about 2.0 g/(kg·d).