芥子咳喘贴早期安全性评价实验研究  

Experimental Evaluation of Early Safety of Jiezi Kechuan Plaster

作　　者：王道涵[1] 袁晓雯[2] 乔艳雪 赵荣华[3] 王素梅[1] 马雅銮[2] WANG Daohan;YUAN Xiaowen;QIAO Yanxue;ZHAO Ronghua;WANG Sumei;MA Yaluan(Department of Pediatrics,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Institute of Basic Theory for Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Chinese Meteria Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]北京中医药大学东方医院儿科,北京100078 [2]中国中医科学院中医基础理论研究所,北京100700 [3]中国中医科学院中药研究所,北京100700

出　　处：《世界中医药》2023年第21期3065-3069,共5页World Chinese Medicine

基　　金：北京市科委“十病十药”研发项目(Z141100002214009)——芥子咳喘贴治疗小儿支气管炎的成药性研究。

摘　　要：目的:评价芥子咳喘贴早期安全性,为新药临床试验提供可靠依据。方法:以日本大耳白兔和Hartley豚鼠为研究对象,采用皮肤用药急性毒性试验观察空白对照组、芥子咳喘贴常规剂量组、芥子咳喘贴高剂量组日本大耳白兔用药后的一般状况及血生化等;单次及多次给药完整皮肤刺激试验观察日本大耳白兔皮肤有无红斑、水肿,以及上述变化恢复情况和时间;通过过敏试验观察Hartley豚鼠皮肤过敏情况。结果:芥子咳喘贴常规剂量组、芥子咳喘贴高剂量组对日本大耳白兔一般状况无显著影响,其死亡率为0%,肉眼观察皮肤、脊神经及各脏器未见显著异常改变;与空白对照组比较,芥子咳喘贴高剂量组肝脏、肾脏质量及脏器系数显著降低(P<0.05),芥子咳喘贴常规剂量组与空白对照组差异无统计学意义(P>0.05);各组日本大耳白兔血脂、肝功、肾功比较差异无统计学意义(P>0.05);芥子咳喘贴单次给药后,各观察时间点日本大耳白兔给药部位皮肤刺激评分均为0分,多次给药改后,其刺激强度平均分值1.5分,为轻度刺激;未引起Hartley豚鼠皮肤出现红斑、水肿等过敏反应。结论:芥子咳喘贴经急性毒性试验、单次及多次给药完整皮肤刺激试验、皮肤过敏试验均未出现毒性反应,具备无毒、低刺激、无致敏性特点,经皮肤给药安全。Objective:To evaluate the early safety of Jiezi Kechuan Plaster(JKP)and provide a basis for clinical trials of new drugs.Methods:Japanese white rabbits were randomized into blank control(BC),conventional dose JKP(c-JKP),and high-dose JKP(h-JKP)groups.After treatment with JKP,the general situation and biochemical indexes of the rabbits were determined to evaluate the acute toxicity of JKP.Skin irritation tests were performed on Japanese white rabbits with single and multiple doses of JKP,and then the occurrence of erythema and edema and the recovery of above changes were observed.The hypersensitive test was conducted with Hartley guinea pigs.Results:There was no obvious abnormality in the general condition,skin,spinal nerve or organs after the application of JKP at the two doses,and the mortality of rabbits was 0%.Compared with the BC group,the h-JKP group showed decreased liver mass,kidney mass,and organ index(P<0.05),which showed no significant changes in the c-JKP group(P>0.05).No significant differences were observed between three groups in blood lipid levels,liver function,and renal function(P>0.05).After single-dose administration of JKP,the average irritation score was 0 points at each observation point.After multiple-dose administration of JKP,the irritation score was 1.5 points.No allergic reactions such as erythema and edema were observed in the skin of Hartley guinea pigs.Conclusion:JKP is a non-toxic,low-stimulating,non-sensitizing external preparation safe for administration through the skin.

关 键 词：芥子咳喘贴 外用贴剂 支气管炎 安全性评价 急性毒性试验 皮肤刺激试验 皮肤过敏试验 脏器系数 

分 类 号：R242[医药卫生—中医临床基础]