注射用银杏内酯冻干粉的安全性实验和毒理学研究

The safety tests and toxicological studies on Injectable Ginkgolides Lyophilized Powder

目的 :在考察注射用银杏内酯冻干粉安全性的基础上 ,探讨其毒理作用和临床应用安全剂量范围。方法 :按照新药临床前毒理研究规范 ,通过不同的动物实验 ,在不同剂量下先后进行注射用银杏内酯冻干粉的安全性实验 ,急性毒性实验和长期毒性实验。结果 :注射用银杏内酯冻干粉的制剂安全 ,符合注射剂型标准 ;急性毒性实验未测出LD5 0 ,最大耐受量>12 0 0mg/kg ,相当于临床日用量的 72 3倍 ;长期毒性实验的最大剂量为 10 0mg/kg ,相当于临床日用量的 12 0倍 ,实验动物的外观、一般行为活动、正常生长发育、内脏组织结构等多项指标均无明显的影响 ,给药组与对照组经统计学比较均无明显差异(P >0 .0 5 )。结论 :安全性实验和毒理学研究表明 。

Objective On the basis of safety studies of Injectable Ginkgolides Lyophilized Powder (IGP), to determine its toxicity and the safe dosage window. Method According to the Preclinical Research Regulation of New Drug, we experimented with animals such as mice, rats, rabbits, guinea pigs, Beagle dogs for the safety tests, acute and long-term toxicological studies, respectively. Results The Preparation of IGP was reliable and safe; the lethal dose 50(LD50) wasn't detected in the acute toxicological study; and the maximum tolerance dose was 1200mg/kg and 723 times as much as the clinical dose a day; the maximum dose in the long-term toxicological studies was 100mg/kg and 120 times as much as the clinical dose a day, there was no significant difference between the study groups and the control in general behavior, growth and development, internal organs etc. Conclusion The results suggest that IGP is safe for clinical application.