麻芥平喘巴布剂皮肤用药安全性实验研究

Experimental study on dermal safety of Majie Pingchuan cataplasm

目的探讨麻芥平喘巴布剂皮肤用药的安全性。方法 1家兔急性毒性实验:家兔12只,随机平均分为3组,退毛及皮肤破损处理,分别给予空白基质巴布剂和麻芥平喘巴布剂,24 h后观察动物全身中毒情况;2家兔皮肤刺激实验:家兔16只,随机平均分为4组,退毛及皮肤破损处理,左侧给予1/12贴麻芥平喘巴布剂,右侧给予1/12贴巴布剂基质贴剂,单次刺激实验24 h后观察红斑和水肿情况,多次刺激实验连续7 d后观察红斑和水肿情况;3豚鼠皮肤过敏实验:豚鼠30只,随机平均分为3组,退毛处理后在左侧分别给予1/12贴空白基质、1/12贴麻芥平喘巴布剂和1%的2,4-二硝基氯苯液0.2 m L,第28天在实验动物右侧给予等量药物,其中阳性对照组涂抹0.1%的2,4-二硝基氯苯液,6 h后多次观察皮肤变态反应情况。结果在急性毒性实验中,家兔未出现动物死亡及其他生理异常情况;在单次刺激性实验中,家兔未出现红斑、水肿等刺激反应,在多次刺激性实验中,家兔皮肤用药部位有不明显红斑,48 h内消失,无水肿;在过敏性实验中,麻芥平喘巴布剂组未出现红斑及水肿,致敏率为0%。结论麻芥平喘巴布剂未引起家兔出现急性毒性反应,对家兔完整及破损皮肤无任何刺激性反应,对豚鼠完整皮肤无致敏作用。麻芥平喘巴布剂临床用药安全无毒。

Objective To investigate the safety of Majie Pingchuan cataplasm on skin. Methods 1Acute toxicity test. Twelve rabbits were randomly divided into three groups with hair removed and skin damaged,systemic poisoning situation was observed after patching blank matrix cataplasm and Majie Pingchuan cataplasm. 2Skin irritation test. Sixteen rabbits were randomly divided into four groups with hair removed and skin damaged,one twelfth of one sheet of blank matrix cataplasm and Majie Pingchuan cataplasm were separately patched on left or right side skin,erythema and edema were observed in single and repeated stimulation tests. 3Skin allegy test. Thirty guinea pigs were randomly divided into three groups,one twelfth of one sheet of blank matrix cataplasm,Majie Pingchuan cataplasm,0. 2 m L of 2,4-dinitrochlorobenzene were patched on the left side skin. On 28 thday allergic reaction was observed after patching the same excitants six hours continuously on the right skin. Results In the acute toxicity test,there was no death and abnormal physiological conditions in rabbits. In the single stimulus test,erythema and edema did not appear. In the repeated stimulation tset,there was slight erythema disappearing in 48 h,and no edema. In allergy test,Majie Pingchuan cataplasm group did not appear erythema and edema,the sensitization rate was 0. Conclusion Majie Pingchuan Cataplasm had no acute toxicity and irritation on intacted or injured skin of rabbits. There was no allergic reaction in guinea pig skin. Majie Pingchuan cataplasm is safe and non-toxic.