地乌胶囊长期毒性试验

The Iong - Term Toxic Test of Diwu Capsule

目的:观察连续给予地乌胶囊后可能对机体产生的毒性反应,为临床安全用药提供试验依据。方法:地乌胶囊灌胃给药,3组大鼠一日用药剂量分别为48/kg,2g/kg及1g/kg,相当于成人(50kg)一日口服量(0.06g/kg)的66.67倍、33.33倍、16.67倍,试验期为70d,相当于临床用药的3个疗程。结果:试验期间大鼠饮食、活动及大小便等均正常,体重增长,血象,血液生化指标,脏器系数,脏器组织的肉眼观察和病理组织学检查结果均未见异常,与正常对照组比,均无显著性差异(P>0.05),停药2周后,各项指标检查亦未见异常。结论:地乌胶囊在临床用药剂量范围内是安全的。

To observe the possible toxic reaction to organism of Diwu capsule after Coutinuous affering Diwu Capsule to affer trial evidences for clinical use of medicine of safety. Methods: The method of perfusive stomach, three groups of large white rats fill Diwu capsule daily dosage of medicine: 4g/kg, 2g/kg and 1g/kg, as the amount of a mature people (50kg) daily dosage medicine 0.06g/kg, as 66.67 times, 33.33 times and 16.67 times, trial time is to days, as the clinical usage of medicine 3 pe-rionds of time. Results: During the tried time, the large white rats ate a lot, activity, excrement and urine keeps normal; weight gain, the reult of hemogram, blood chemical examination, organ coefficient, organ organization, macroscopic and histopathology examination keeps normal, compared to regartarity, it has nothing unusual (P > 0.05) after stopping medicine for two weeks, each examination also has nothing unusual. Conclusion: Diwu capsule is safe within the clinical dosage of medicine.