目的：研究伤科敷液涂剂经皮肤用药的皮肤毒性和安全性。方法2014年5月—2015年3月期间选择清洁级家兔(白色长毛)、豚鼠(DHP)作为实验动物,用家兔急性皮肤毒性试验、豚鼠皮肤过敏性试验、家兔皮肤刺激性试验,研究伤科敷液涂剂经皮肤用药的急性毒性、过敏性、刺激性。结果伤科敷液涂剂对家兔急性皮肤毒性试验,在皮肤完整和破损两种状态下,均未见皮肤毒性反应；伤科敷液涂剂对豚鼠皮肤过敏性试验,未见过敏反应；家兔完整皮肤试验无刺激性,破损皮肤试验高剂量组、中剂量组损伤皮肤刺激指数达到0.6、0.3,用药后48~72 h缓解痊愈为0.3和0,其他组刺激指数均为0,涂药区与空白对照区差异无统计学意义(P>0.05)。结论伤科敷液涂剂经皮肤给药无明显皮肤毒性,安全性良好。%Objective Skin toxicity and safety of Paint shangkefuye after skin administration. Methods During the pe-riod of May 2014 and March 2015 choose clean (white hair) in rabbits and guinea pigs (DHP) as experimental animals, the rabbit skin acute toxicity test, skin of guinea pig allergic test and rabbit skin stimulus test, the injury research of deposited liquid paint with skin medication acute toxicity, allergic, irritant. Results Trauma dressing liquid paint on rabbits with acute skin toxicity test and in skin integrity and damage state under. There were no toxic skin reaction;Apply liquid paint on the skin of guinea pig Department of Traumatology allergic test, no allergic reaction; Rabbit skin integrity test has no irritation, damaged skin test in high dose group, middle dose group damage the skin stimulation in-dex reached 0.6, 0.3, medication after 48~72 h ease recovery is 0.3 and 0. Other groups stimulation index was 0, the applicator zone and a blank control had no significant difference (P> 0.05). Conclusion Shangkefuye Paint medication through the skin without significant acute dermal toxicity, good safety.
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