布替萘芬霜剂局部给药对家兔慢性毒性实验研究

Experimental Study on the Chronic Toxicity of Butenafine Cream Local Delivery in Rabbits

目的 :观察布替萘芬霜剂长期大剂量皮肤局部使用对家兔的慢性毒性作用。方法 :将 2 4只家兔随机分成 4组 :对照组、布替萘芬高 (2 0 % )、中 (10 % )、低 (5 % )剂量组 ,连续皮肤局部使用 1个月后 ,进行全身情况、血液学、血液生化、组织学检查。结果 :除敷药的局部皮肤有些异常外 ,实验组家兔全身情况、血液学参数、血液生化指标、组织学检查与对照组相比均无明显差异。结论 :布替萘芬局部给药安全 ,临床应用可靠。

Objective: To observe the chronic toxic effect of butenafine (BT) cream local delivery in rabbits with large dose and long term administration. Methods: 24 rabbits were divided randomly into four groups: control group (with drug free cream), BT high dosage group (20%), BT middle dosage group (10%) and low dosage group (5%). After 1 month continue local drug delivery in rabbits, the systemic condition, hematology, serum biochemistry and histology of rabbits were measured. Results: There were no significant differences in the systemic condition, hematology, serum biochemistry and histology between experimental and control group, except for light abnormity of local skin. Conclutions: Butenafine can be safely local used in clinical trial.