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
王道涵 1袁晓雯 2乔艳雪 2赵荣华 3王素梅 1马雅銮2
作者信息
- 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
- 折叠
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.
Abstract
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 eval-uate 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 con-ducted with Hartley guinea pigs.Results:There was no obvious abnormality in the general condition,skin,spinal nerve or organs af-ter 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 multi-ple-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 ad-ministration 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Key words
Jiezi Kechuan Plaster/External preparation/Bronchitis/Safety evaluation/Acute toxicity test/Skin irritation test/Skin hypersensitivity test/Organ index引用本文复制引用
基金项目
北京市科委"十病十药"研发项目(Z141100002214009)
出版年
2023
国家科技期刊平台
NSTL
维普
万方数据