鬼二白凝胶的制备及安全性评价

摘 要 目的：制备鬼二白凝胶，并进行安全性试验。方法: 将处方药材经回流提取、浓缩、干燥、粉碎制成干粉，溶于乙醇后加入丙二醇，混入调制好的卡波姆，制成凝胶剂；分别对进行大鼠皮肤急性毒性、豚鼠皮肤刺激性、豚鼠皮肤过敏性及大鼠长期毒性试验，观察大鼠一般情况及体质量，并检测大鼠血液生化情况和心、脑、肝、肾变化情况。结果: 皮肤急性毒性试验中，大鼠完整皮肤及破损皮肤均未出现红斑及水肿；豚鼠皮肤刺激性试验中，仅破损皮肤组出现轻度红斑及水肿，完整皮肤组未出现异常情况；豚鼠皮肤过敏性试验中，仅高剂量组产生轻微过敏反应，其他组豚鼠均正常；长期毒性试验中，仅高剂量组大鼠血液生化指标有一定影响，停药14 d后均恢复正常。结论: 鬼二白凝胶临床剂量用于大鼠及豚鼠皮肤安全性良好。

Preparation and Safety Evaluation of Gui Erbai Gel

ABSTRACT Objective: To prepare Gui Erbai gel and conduct safety test. Methods: The crude medical material was reflux extracted, concentrated, dried, powdered and dissolved into ethanol solution, and then propylene glycol was added followed by the premixed carbomer to obtain Gui Erbai gel. The safety was tested on the experimental animals to evaluate the acute and chronic dermal toxicity in rats, and the skin irritation and allergic in guinea pigs. The general conditions and BMI of rats were observed, the blood biochemical indices and the changes of heart, brain, liver and kidney were detected as well.Results: In the test of acute dermal toxicity, erythema and edema were not found on the complete and injured skin of rats; in the test of skin irritation, mild erythema and edema were only found on the damaged skin of guinea pigs, while the complete skin remained normal; in the allergic experiment, mild allergic reaction was only found in the guinea pigs treated with high dose of the gel, while the other groups remained normal; in the chronic toxicity test, only high dose of the gel showed certain impact on the blood biochemical indices of rats, and after 14 day drug withdrawal, all the indices returned to normal. Conclusion:The clinical dose of Gui Erbai gel is safe in skin application.