寒立消贴敷剂的部分安全性药理学实验研究  

An Experimental Study on the Safety Pharmacology of Hanlixiao Sticking Agent

作　　者：吴洋[1] 杨金慧[2] 张巍琼[2] 李东云[2] 粟荣[2] 

机构地区：[1]云南省中医医院,云南昆明650021 [2]云南中医学院,云南昆明650011

出　　处：《云南中医中药杂志》2013年第9期59-61,89,共3页Yunnan Journal of Traditional Chinese Medicine and Materia Medica

基　　金：云南省卫生厅科技项目(NO:2011WS20025)

摘　　要：目的通过家兔及豚鼠的皮肤给药急性毒性试验、皮肤刺激性试验及皮肤过敏性试验,以证实寒立消贴敷剂的安全性,也为进一步开发利用该药打下基础。方法 1、24只健康家兔雌雄各半随机分为对照组、寒立消高剂量组、低剂量组3个组,观察去除受试药物1、24、48、72h至第14d动物的中毒反应和死亡情况。2、16只健康家兔雌雄各半随机分为完整皮肤受试药赋形剂组、受损皮肤受试药赋形剂组,采用同体左右侧自身对比的方法,进行皮肤刺激性试验。3、30只豚鼠雌雄各半随机分为赋形剂对照组、阳性药对照组、受试药组,进行皮过敏性试验。结果 1、寒立消贴敷剂大、小剂量,短期内接触家兔皮肤,未见显著毒性反应。2、寒立消贴敷剂及其赋型剂分别单次皮肤给药对家兔无皮肤刺激反应。3、寒立消贴敷剂外用于豚鼠,未见皮肤过敏反应。结论通过以上实验证明寒立消贴敷剂是一种安全有效,无毒的制剂。Objective: To confirm the safety of Hanlixiao Sticking Agent through acute toxicity test,skin irritation test and skin allergy tests of rabbit and guinea pig skin administration and lay the foundation for the further use of the drug. Methods: A. 24 healthy male and female rabbits were randomly divided into one control group,and one Hanlixiao Sticking Agent high dose group and one low dose group to observe the toxic reactions and the death of the test rabbits in the drug administration from 1h,24h,48h and 72h to 14 days. B. 16 healthy male and female rabbits were randomly divided into one full skin test excipient group and one damaged skin test excipient group to conduct the skin irritation test by using consubstantial right and left sided contrast. C. 30 male and female guinea pigs were randomly divided into one excipient control group,one positive control group and one drug test group for skin allergy test. Results: A. The rabbit skin exposing to large and small doses of Hanlixiao Sticking Agents in short- term showed no significant toxicity. B. Hanlixiao Sticking Agent and its excipients showed no skin irritation in rabbits by a single skin administration. C. Hanlixiao Sticking Agent had no allergic skin reaction on the guinea pigs by external use. Conclusion: The above tests prove that Hanlixiao Sticking Agent is a safe,effective and non- toxic agent.

关 键 词：寒立消贴敷剂 安全性 急性毒性 刺激性 过敏反应 

分 类 号：R285.5[医药卫生—中药学]