吡哌酸骨架散的皮肤安全性评价  

Evaluation of Cutaneous Safety of Bipemidic acid Matrix Powder

作　　者：孙昕[1] 谷媛媛 杨雪萍[1] 

机构地区：[1]解放军88医院药剂科,山东泰安271000

出　　处：《解放军药学学报》2013年第6期552-553,584,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的评价吡哌酸骨架散皮肤局部用药的安全性。方法将0.1 g吡哌酸骨架散均匀撒布于豚鼠背部皮肤,3次致敏接触,隔14 d后,再涂药激发接触,观察过敏反应;吡哌酸骨架散多次重复撒布在豚鼠完整及破损皮肤,采用同体左右侧自身对比,用药期间每日观察局部皮肤红斑及水肿情况;将高、低剂量的吡哌酸骨架散用于豚鼠背部完整或破损受试皮肤,观察其产生的急性毒性情况。结果吡哌酸骨架散未见皮肤与全身过敏反应;一次或多次给药对豚鼠完整皮肤及破损皮肤均无刺激性;大剂量也未见急性毒性反应。结论本品用于豚鼠皮肤安全性较好。Objective To evaluate the dermal safety of bipemidic acid matrix powder（BAMP）. Methods The skin of Guinea pigs’ backs was bestrewed by 0. 1 g BAMP and contacted allergens three times. Then it was stimulated by a coated drug and the allergic reaction was observed after 14 days. BAMP was scattered repeatedly on the intact and damaged skin. The left side of Guinea pigs’ skin was compared with the right side. The erythema and edema of the local skin were observed every day during the trial period. BAMP at a low dose（0. 05 g·cm-2） and high dose（0. 2 g·cm-2） was applied to normal or damaged areas of the backs of Guinea pigs for acute toxicity test. Results BAMP produced no hypersensitive reaction on the skin of Guinea pigs after repeated sensitization. Single or multiple doses of BAMP caused no irritation on the normal skin or damaged skin of Guinea pigs. No acute toxicity reaction at a high dose of BAMP was observed. Conclusion BAMP is safe for the skin of Guinea pigs.

关 键 词：吡哌酸骨架散 安全性评价 过敏试验 刺激性试验 急性毒性试验 

分 类 号：R96[医药卫生—药理学]