消瘀止痛喷雾剂皮肤用药安全性研究

The Safety of the Xiaoyuzhitong Spray for Dermatologic

目的:探讨消瘀止痛喷雾剂皮肤用药的安全性。方法:采用动物皮肤急性毒性试验、皮肤刺激性试验和皮肤过敏试验对消瘀止痛喷雾剂进行安全性评价。结果:消瘀止痛喷雾剂最大耐受剂量(MTD)为17.2 g(生药)/kg,为临床用药剂量的344倍。高浓度[4.02 g(生药)/kg]消瘀止痛喷雾剂喷涂破损皮肤影响雄性大鼠的体重增长;临床用药剂量[0.201 g(生药)/kg]喷雾给药对家兔皮肤无刺激作用,对豚鼠皮肤无致敏作用。结论:消瘀止痛喷雾剂毒性小,是一种安全性较好的外用制剂。

Objective：To evaluate the safety of Xiaoyuzhitong spray, the dermatologic drug. Methods：Acute toxicity test, skin irritation test and skin allergy test were performed to evaluate its safety Results： The maximum tolerated dose （MTD） of Xiaoyuzhitong spray was 17.2 g/kg（crude drug/body weight） ,the 344-fold clinical dosage. A high-density dosage of 4.02 g/kg affected the rats＇ weight. There were no skin irritation in rabbits and no skin allergy in guinea pigs after administration of clinical dosage of the spray of 0. 201 g/kg. Conclusion： Xiaoyuzhitong Spray with a low acute toxicity is a safe skin preparation for external use.