血余炭纳米纤维膜皮肤刺激性和过敏性实验研究

目的:观察血余炭纳米纤维膜外用对皮肤的刺激性和过敏性反应,为评价其安全性提供参考。方法:采用家兔皮肤刺激实验,分完整皮肤组和损伤皮肤组,分别在给药1 d、连续给药7 d后,观察皮肤有无红斑、水肿等刺激反应;采用豚鼠皮肤过敏实验,每周贴敷血余炭纳米纤维膜致敏1次,连续3周,于首次致敏后的第28天皮肤再次给药进行攻击,观察皮肤有无红斑、水肿等过敏反应。结果:血余炭纳米纤维膜对家兔的完整皮肤和破损皮肤,经单次给药或多次给药24 h后去除敷料,分别于1、24、48、72 h观察,均未见红斑及水肿,刺激反应平均分值均<0.5,无刺激性;豚鼠皮肤过敏实验中,未出现皮肤明显红斑、水肿等皮肤过敏反应及其他全身性过敏反应。结论:血余炭纳米纤维膜对家兔完整皮肤和损伤皮肤不会引起刺激性反应,对豚鼠皮肤无过敏性反应,具有良好的皮肤用药安全性。

Experimental study on skin irritation and anaphylaxis of nano-fibers tunic carbonized hair loaded drug

Objective： To evaluate the safety of the nano-fibers tunic carbonized hair loaded drug （NTCH） by skin irritation and anaphylaxis experiment. Methods： Skin irritation test was carried out on the integral skin and the damaged skin of rabbits, which was observed at 1 day and 7 days with the NTCH. Skin allergy test was carried out on the slain of the guinea pigs with NTCH once a week for 3 consecutive weeks, and the animals were stimulated at the 28~ day. Then irritation and allergic reactions of the animals were investigated. Results： There was no erythema and edema at 1 h, 24 h, 48 h and 72 h after single dose or multiple doses of NTCH. The average reaction values of the NTCH on integral and damaged skin were lower than 0.5, and there was no irritation of NTCH on integral and damaged skin of rabbits. There was no allergic reactions such as erythema and edema or systemic allergic reactions in guinea pigs skin test. Conclusion： The NTCH is a safe external drug without irritation on integral and damaged skin of rabbit and anaphylaxis effect on the skin of guinea pig.