701跌打镇痛膏安全性实验研究

Toxicology Research of 701 Dieda Zhentong Ointment

目的研究701跌打镇痛膏经皮给药急性毒性、皮肤刺激性和过敏性,为其临床应用和推广提供实验依据。方法选用新西兰兔和Hartley豚鼠为研究对象,分别采用最大耐受量法和同体左右侧对照给药的方法考察701跌打镇痛膏经皮给药的急性毒性、皮肤刺激性和过敏性。结果 701跌打镇痛膏经皮给药后对新西兰兔未见明显毒性反应;对新西兰兔破损皮肤会产生刺激性反应,但此刺激性可于停药后14 d完全恢复;对新西兰兔完整皮肤也会产生轻度刺激性,但此刺激性是一过性反应;对Hartley豚鼠未产生明显过敏反应。结论 701跌打镇痛膏具有良好的安全性,经皮单次和多次给药后除轻微的皮肤刺激性外未见其他明显毒性反应,且所产生的皮肤刺激性均为可逆性反应,值得进一步推广应用。但在临床应用中701跌打镇痛膏应尽量在损伤局部皮肤无明显破损时使用,尽量避免在破损皮肤上使用,以减少药物对皮肤的刺激性。

Objective To investigate the transdermal acute toxicity, skin irritation and allergy induced by 701 Dieda Zhentong ointment, and so as to provide experimental evidence for its clinical application and promotion. Methods New Zealand rabbit and Hartley guinea pigs were used as the research object. The acute toxicity, skin irritation and allergy of 701 Dieda Zhentong ointment were investigated by maximum tolerated and autologous left and right side of controlled drug delivery methods. Results After percutaneous drug delivery to New Zealand rabbit, the 701 Dieda Zhentong ointment had no obvious toxic effects. In New Zealand rabbit, this drug had irritating reaction to its damaged skin, and the stimulating will be completely recovered 14 d after drug withdrawal. It could also have mild irritating effect on the integral skin of New Zealand rabbit, but it was a transient irritating reaction. It did not have allergic reaction on Hartley guinea pigs. Conclusion 701 Dieda Zhentong ointment has good security, percutaneous after single and multiple dosing had no obvious toxicity effect, except mild skin irritation, and the skin irritation are reversible reaction. Therefore, this drug is worthy for further popularization and application in the clinical. 701 Dieda Zhentong ointment should be used when no obvious local skin damage, avoid to use on the damaged skin, in order to reduce drug irritating to the skin.