吴氏侗药烧伤油安全性评价  

Safety Evaluation of Wu′s Dong Medicine Burn Oil

作　　者：兰岚 唐佳璇 石秋梅 薛凯阳 崔瑾 LAN Lan;TANG Jiaxuan;SHI Qiumei;XUE Kaiyang;CUI Jin(Graduate School of Guizhou University of Traditional Chinese Medicine,Guiyang,Guizhou,China 550002)

机构地区：[1]贵州中医药大学研究生院,贵州贵阳550002

出　　处：《中国药业》2022年第12期64-68,共5页China Pharmaceuticals

基　　金：贵州省科技计划项目[黔科合后补助2020〔3004〕]。

摘　　要：目的探讨吴氏侗药烧伤油的安全性。方法取30只SD大鼠进行皮肤急性毒性实验,随机分为空白对照组(A组,等量生理盐水)、皮肤完整组(B组,吴氏侗药烧伤油2 mL)和皮肤破损组(C组,吴氏侗药烧伤油2 mL),各10只;各组大鼠背部脊柱两侧脱毛并涂抹相应药物或生理盐水,每天3次,连续7 d,分别在给药后1,24,48 h和第7天记录大鼠体质量,每天笼边观察大鼠体貌外观、行为活动,饮食排泄等。取20只SD大鼠进行皮肤刺激性实验,将大鼠随机分为皮肤完整组(D组)和皮肤破损组(E组),各10只;大鼠背部脱毛后,以无菌针头划破以制备破损皮肤;两组大鼠均采用同体左右侧自身对比法,在大鼠背部左侧涂抹吴氏侗药烧伤油,右侧涂抹等量生理盐水,每次2 mL,每天3次,连续7 d,观察皮肤红斑和水肿情况。取30只豚鼠进行皮肤过敏性实验,将豚鼠随机分为吴氏侗药烧伤油组(F组,吴氏侗药烧伤油0.2 mL)、阴性对照组(G组,等量生理盐水)和阳性对照组(H组,2,4-二硝基氯苯0.2 mL,致敏浓度1%,激发浓度0.1%);第0,7,14天,各组豚鼠左侧背部脱毛皮肤区域涂抹相应致敏药物进行致敏,第28天,在豚鼠右侧背部相应区域进行激发给药(除阳性对照组外,其余组均同致敏给药)。激发给药后分别于6,24,48,72 h观察豚鼠背部及全身皮肤红斑、水肿等过敏反应症状,计算反应平均值及致敏率。结果皮肤急性毒性试验,与A组比较,给药后B组、C组大鼠体质量均无显著差异(P>0.05),且3组大鼠皮肤、毛发、饮食、分泌物、排泄物、呼吸、眼和黏膜、精神状态、四肢活动均正常,未见大鼠意外及死亡情况;皮肤刺激性实验,D组、E组大鼠左右侧背部刺激评分均为0分,且未见皮肤红斑、水肿等异常情况;皮肤过敏性实验中,激发给药6,24,48,72 h后,H组豚鼠皮肤出现红斑、水肿,皮肤局部致敏率100%,F组和G组豚鼠均未见局部或全身过敏反应。结论吴氏侗药�Objective To evaluate the safety of Wu′s Dong Medicine Burn Oil.Methods Thirty SD rats were randomly divided into blank control group(group A,equal volume of normal saline),intact skin group(group B,2 mL of Wu′s Dong Medicine Burn Oil)and skin damage group(group C,2 mL of Wu′s Dong Medicine Burn Oil),with 10 rats in each group.The rats in each group were depilated on both sides of the dorsal spine and smeared with corresponding drugs or normal saline three times a day for 7 d.The body mass of the rats was recorded at 1,24,48 h and 7 d after administration.The physical appearance,behavioral activities and dietary and excretion of the rats were observed at the edge of the cage every day.Twenty SD rats were selected for the skin irritation test,they were randomly divided into the intact skin group(group D)and skin damage group(group E),with 10 rats in each group.After depilation of the back,rats were cut with sterile needles to prepare damaged skin.Self-comparison method of left and right sides of the same body was conducted on the rats in the two groups,the left side of the back of the rats was coated with Wu′s Dong Medicine Burn Oil,and the right side was coated with the equal volume of normal saline,2 mL each time,three times a day for 7 d.The skin erythema and edema were observed.Thirty guinea pigs were selected for the skin allergy test,they were randomly divided into Wu′s Dong Medicine Burn Oil group(group F,0.2 mL of Wu′s Dong Medicine Burn Oil),negative control group(group G,equal volume of normal saline)and positive control group(group H,0.2 mL of 2,4-dinitrochlorobenzene,sensitization concentration of 1%,excitation concentration of 0.1%).On days 0,7 and 14,the corresponding sensitizing drugs were applied to the depilated skin area on the left back of guinea pigs in each group for sensitization,and on day 28,the corresponding area on the right back of guinea pigs was irritantly administrated(except for the positive control group,the other groups were sensitively administrated).The allergic react

关 键 词：民族医学 吴氏侗药烧伤油 皮肤急性毒性 皮肤刺激性 皮肤过敏性 

分 类 号：R932[医药卫生—生药学] R285[医药卫生—药学]