银杏内酯软胶囊毒理学研究

目的：观察动物ig银杏内酯软胶囊的急性毒性和长期毒性，确定无毒反应的剂量，以评估银杏内酯软胶囊长期用药的安全性。方法：以最大浓度，最大体积的银杏内酯软胶囊ig昆明种小鼠一次，测定最大耐受量。以高、中、低3个剂量对大鼠进行连续灌胃给药26周，于用药13、26周分别各处死1／3动物观察大鼠的生长发育，摄食量，血液细胞学及生化学指征，脏器系数及组织病理学检查，停药观察4周后再处死剩余1／3动物作相应检查。结果表明：小鼠1d内1次ig银杏内酯软胶囊最大耐受量≥2997mg/kg，各给药组与对照组检查指标结果统计分析均无明显差异（P≥0．05），结论：ig银杏内酯软胶囊对小鼠、大鼠均无明显的毒性反应。

TOXICOLOGIC STUDY ON GINKGOLIDES CAPSULES

Objective: To observe the acute toxicity Ginkgolides Capsules(GC) in mice and its long-period toxicity in rats,so evaluated the safety dosage window in clinical application. Methods:The maximal tolerance dose was tested by gastric perfusion of single oral dose of GC.Three groups of rats (in high ,moderate and low dosage of GC)were administered with repeated gastric perfusion of GC for 26 weeks.Body weight,hematological and hematobiochemical parameters,coefficient and histomorphological figure of organs were examined in 13,26 weeks and 4 weeks after the cessation of GC.Results: The oral maximal tolerance dose of GC in mice was more than 2997mg/kg(equal to 900 times of clinical dose).There was no significant difference between the test groups and the control in all tested parameters. Conclusion:The GC have no obviously toxicity ,so suggest that GC is safe for clinical application.