复方镰形棘豆凝胶剂的皮肤安全性评价

目的:制备一种外用复方镰形棘豆凝胶剂,并对其皮肤用药的安全性进行评价。方法:选用壳聚糖为凝胶基质制备复方镰形棘豆凝胶剂;用复方镰形棘豆凝胶剂考察豚鼠皮肤致敏性、家兔皮肤刺激试验、急性毒性试验和30 d 长期毒性试验。结果:复方镰形棘豆凝胶剂对豚鼠无致敏性,对家兔完整皮肤及破损皮肤无刺激;急性毒性试验中家兔体质量变化无差异,未见死亡及中毒反应发生;家兔连续给药30 d 后凝胶剂低中高剂量组对家兔的一般情况、体质量、脏器系数及病理组织、血液学指标、血液生化学指标均无明显影响,恢复期亦无延迟性毒性反应。结论:制备的复方镰形棘豆凝胶剂是一种安全性较高的外用制剂。

Evaluation on skin safety for compound Oxytropis Falcata Bung gel

OBJECTIVE To prepare a compound of Oxytropis Falcata Bung gel and evaluate its skin safety.METHODS Compound of Oxytropis Falcata Bung gel was prepared with chitosan gel matrix.The gel was used to investigate skin sensitization on guinea pig,skin irritation on rabbit,to perform acute toxicity test and 30 days long term toxicity test on rabbit.RESULTS Compound of Oxytropis Falcata Bung gel had good stability, had no induced allergic reaction on skin of guinea pigs,irritation on skin of rabbits or acute toxicity reaction,no animal death or other toxic reactions.The product had no impacts on general conditions,weight,organ coefficients,histopathlolgocal changes,hematological indexes,or blood biochemistry.The delayed toxicity reaction was not shown after drug administration. CONCLUSION Compound of Oxytropis Falcata Bung gel is an external product with high safety.