风痛灵擦剂的毒理学研究

目的:评价风痛灵擦剂外用的安全性。方法:皮肤急性毒性试验,皮肤长期毒性试验,皮肤刺激性试验,皮肤过敏试验。结果:急性毒性试验表明,豚鼠一日内多次外涂风痛灵,总量2.5m l/kg体重(相当于临床成人用量的35倍),七日内未发现明显毒性反应;长期毒性试验表明,以相当于临床用药量的28倍、7倍风痛灵给豚鼠外涂,连续给药18天。结果破损皮肤高剂量组给药9天后出现体重增加减慢、食欲下降,与对照组比较有显著性差异,各组均无动物死亡,亦未见其它明显毒性反应,血象及血清生化学指标、病理学检查未见明显异常;以相当于临床成人用量31.56倍的风痛灵给家兔作完整皮肤和破损皮肤的一次、多次给药的刺激性试验,结果一次给药对家兔完整皮肤未发现刺激性反应,破损皮肤呈现轻度刺激性。连续给药一周,完整皮肤表现为轻度刺激性反应(3日后出现),破损皮肤呈现轻度至中度刺激性反应;过敏试验表明,风痛灵对豚鼠皮肤无致敏性。结论:风痛灵对完整皮肤外用安全性较好,对破损皮肤有一定的刺激性反应,建议破损皮肤避免使用。

Toxicological study on fengtongling liniment

Objective:To estimate the safety of Fengtongling liniment applied on skins.Methods:The toxicity was observed in the acute toxicity test,the long-term toxicity test,the dermal irritation test and the dermal allergy test.Results:The acute toxicity test showed that,Fengtongling was applied on normal and wounded skin of guinea pigs with the dosage of 2.5ml/kg(35 times equal to clinic use),there were no obvious symptoms of intoxication; and no one died in 7 days.The long-term toxicity test showed that,Fengtongling was applied for 18 days continuously at the dose of 28,7 times equal to clinic usage,it can inhibit the increasing of weight of guinea pigs.in wounded skin of high dosage.No adverse effects on hematologic,biochemical and histopathological examinations were observed.No irritation reaction occurred in complete skin after applied Fengtongling once at the dose of 31.56 times equal to clinic usage,but in injured skin,light irritation reaction occurred;After applied Fengtongling more times,there was the slight stimulation to the normal skin(observed after 3 days),and slight to medorate stimulation to the wounded skin of rabbits The dermal allergy test showed that it didn't induce allergic reation in guinea pigs.Conclusions: Fengtongling has better safety on complete skin for short-term use,but shoud he avoided on injured skin.