海马追风膏的毒理学研究

Toxicological Study on Haimazhuifeng Ointment

目的：评价海马追风膏外用的安全性。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，海马追风膏1．4g／Kg、0．7g／Kg剂量（相当于临床日用量的217．8、108．9倍），贴膏面积6cm×6cm，24h内一次给药，观察7d，各组均有部分动物（20％～40％）敷贴部位皮肤出现轻度红肿，72h后症状消失。未见其它明显毒性反应，7d内动物无一死亡；长期毒性试验表明，海马追风膏0．70g／Kg、0．175g／Kg剂量（相当于人临床用量的108．9、27．2倍）连续对豚鼠外用给药30d及停药后观察15d，给药后，20％～30％动物皮肤出现红斑、破损皮肤组约半数以上动物皮肤出现红斑，破损皮肤高剂量组体重增长呈减慢趋势。各组均无动物死亡，未见其它明显的毒性反应，血象及血清生化指标、病理组织学检查未见明显异常；皮肤刺激性试验表明，以相当于临床成人用量35．0倍的海马追风膏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：海马追风膏一次给药对家兔完整皮肤无明显刺激，破损皮肤呈现轻度刺激性。连续给药1w，完整皮肤表现为轻度刺激性，破损皮肤呈现中度刺激性反应；过敏试验表明，海马追风膏对豚鼠皮肤无致敏性。结论：海马追风膏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。

Objective：To estimate the safety of Haimazhuifeng ointment applied on skin. 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 a cute toxicity test showed that, Haimazhuifeng ointment was applied on normal and wounded skin of guinea pigs with the dosage of 1.4.0.7g/kg,（217.8.108.9 times equal to clinic dosage） ,the pasted area was 6×6cm, slight irritation occurred in 24 hours in a part of animals （20 % - 40 % ） ,the reaction disappeared in 72 hours. There were no obvious symptoms of intoxication; and no one died in 7 days. The long-term toxicity test showed that, Haimazhuifeng ointment was applied for 30 days continuously at the dose of 0.70g/Kg.0. 175g/Kg （108.9.27.2 times equal to clinic dosage）, then the reaction was observed for 15 days. The high dosage of the ointment inhibited the increasing of the weight of guinea pigs in wounded skin. No adverse effects on hematologic, biochemical and histopathological examinations were observed. The dermal irritation test showed that, no irritation reaction occurred in complete skin after applied Haimazhuifeng ointment once at the dose of 35.0 times equal to clinic dosage, but in injured skin, slight irritation reaction occurred; after applied Haimazhuifeng ointment more times, there was slight stimulation to the normal skin （observed after 7 days） , and medorate stimulation to the wounded skin. The dermal allergy test showed that it didn＇t induce allergic reaction in guinea pigs. Conclusion： Haimazhuifeng ointment has better safety on complete skin and a certain irritation on wounded skin, so it should not be used on impaired skin.