复方肤参霜的抗炎止痒作用及安全性评价  

Antipruritic Effects of Compound Fushen Cream and Its Safety Evaluation

作　　者：彭芳辰[1] 郑斌[1] 王晶[1] 张慧[1] 陈丽芳[2] 郝杰[1] 雷崐[3] 康静[4] PENG Fangchen;ZHENG Bin;WANG Jing;ZHANG Hui;CHEN Lifang;HAO Jie;LEI Kun;KANG Jing(Dept.of Pharmacy,Shanxi Provincial People’s Hospital,Taiyuan 030012,China;Dept.of Dermatology,Shanxi Provincial People’s Hospital,Taiyuan 030012,China;Dept.of Endocrinology,Shanxi Provincial People’s Hospital,Taiyuan 030012,China;Dept.of Traditional Chinese Medicine,Shanxi Provincial People’s Hospital,Taiyuan 030012,China)

机构地区：[1]山西省人民医院药学部临床药学科,太原030012 [2]山西省人民医院皮肤科,太原030012 [3]山西省人民医院内分泌科,太原030012 [4]山西省人民医院中医科,太原030012

出　　处：《中国医院用药评价与分析》2022年第2期137-141,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：山西省科技厅科技攻关项目(No.20150313004-4)。

摘　　要：目的:通过动物实验,评价复方肤参霜的抗炎止痒作用及安全性。方法:(1)取昆明种小鼠50只,随机分为阳性对照组、空白对照组,低、中和高剂量复方肤参霜组,采用二甲苯致小鼠耳廓肿胀,考察复方肤参霜的抗炎作用。(2)取右后足剃毛豚鼠50只,随机分为阳性对照组、空白对照组,低、中和高剂量复方肤参霜组,采用磷酸组胺致豚鼠舔该侧后足,计算致痒阈。(3)取背部去毛的昆明种小鼠40只,随机分为基质组和复方肤参霜组,在小鼠背部脱毛区分别涂抹空白基质和复方肤参霜(每只0.25 g),连续观察7 d小鼠的中毒反应及死亡情况,评价皮肤给药的急性毒性作用。(4)取背部去毛的新西兰兔16只,随机分为单次给药组和多次给药组,再分为完整皮肤组和破损皮肤组。各组在左侧去毛区分别涂抹复方肤参霜(0.5、1.0 g),在右侧去毛区分别涂抹空白基质(1.0 g)和空白(不涂抹)给药后观察皮肤情况,评价皮肤给药的安全性。结果:(1)与空白对照组比较,低、中和高剂量复方肤参霜组小鼠耳廓肿胀度降低,差异均有统计学意义(P<0.05)。(2)与空白对照组比较,阳性对照组和低、中、高剂量复方肤参霜组豚鼠磷酸组胺所致的致痒阈均提高,差异均有统计学意义(P<0.05)。(3)皮肤给药的急性毒性试验中,各组小鼠均存活、主要脏器未见异常,基质组与复方肤参霜组小鼠体重比较,差异无统计学意义(P>0.05)。(4)单次/多次皮肤刺激试验中,完整/破损皮肤组新西兰兔在涂药后均存活,其饮食、行为活动、眼和黏膜均正常,皮肤无明显红斑、水肿现象,且多次皮肤刺激试验破损皮肤组新西兰兔的破损部位已结痂。结论:复方肤参霜在本实验动物模型中具有较明显的抗炎止痒疗效和良好的安全性。OBJECTIVE:To evaluate the antipruritic effects and safety of compound Fushen cream through animal experiments.METHODS:(1)Fifty KM mice were randomly divided into positive control group and blank control group,low,medium and high dose compound Fushen cream groups,xylene was used to cause swelling in the auricle of mice to investigate the anti-inflammatory effect of compound Fushen cream.(2)Fifty guinea pigs with right hind foot shaved were randomly divided into positive control group and blank control group,low,medium and high dose compound Fushen cream groups,histamine phosphate was used to cause guinea pigs to lick the right hind foot,and the itch-causing threshold was calculated.(3)Forty KM mice with dorsal unhaired were randomly divided into substrate group and compound Fushen cream group,the blank substrate and compound Fushen cream(0.25 g each)were applied to the unhaired area,the toxic reactions and death of mice were continuously observed for 7 d to evaluate the acute toxic effects of cutaneous administration.(4)Sixteen New Zealand rabbits with dorsal unhaired were randomly divided into single administration group and multiple administration group,and then divided into intact skin group and damaged skin group.Each group was given compound Fushen cream(0.5 g,1.0 g)on the left side of unhaired area,and blank substrate(1.0 g)and blank(no application)on the right side of unhaired area,so as to observe the skin condition and to evaluate the safety of cutaneous administration.RESULTS:(1)Compared with the blank control group,the auricular swelling of mice in the low,medium and high dose compound Fushen cream groups was reduced,with statistically significant differences(P<0.05).(2)Compared with the blank control group,the positive control group and the low,medium and high dose compound Fushen cream groups were able to increase the itch-causing threshold induced by histamine phosphate,with statistically significant differences(P<0.05).(3)In the acute toxicity test of cutaneous administration,all the mice in each gr

关 键 词：中药 复方肤参霜 抗炎止痒 药效学 安全性 

分 类 号：R932[医药卫生—生药学]