参花外用颗粒皮肤用药安全性评价  

Safety evaluation of Shenhua external granules for topical application

作　　者：喻琴 侯岩 朱聪聪 陈亚 连天雁 陈中建 朱全刚 YU Qin;HOU Yan;ZHU Congcong;CHEN Ya;LIAN Tianyan;CHEN Zhongjian;ZHU Quangang(Shanghai Skin Disease Hospital/Shanghai Innovative Engineering Technology Research Center for External Preparation of Traditional Chinese Medicine,Shanghai 200443)

机构地区：[1]上海市皮肤病医院/上海中药外用制剂创新工程技术研究中心,上海200443

出　　处：《现代中西医结合杂志》2022年第21期2970-2974,3062,共6页Modern Journal of Integrated Traditional Chinese and Western Medicine

基　　金：上海市科委资助项目(21S21901200);上海市皮肤病医院后备学术型博导(17HBDS03)。

摘　　要：目的探讨参花外用颗粒皮肤用药的安全性。方法以健康豚鼠为研究对象,分别进行皮肤刺激性试验、急性毒性试验及皮肤过敏性试验,观察参花外用颗粒皮肤用药的刺激性、急毒性和致敏性。结果参花外用颗粒在临床使用浓度下对豚鼠完整及破损皮肤无刺激性;最大浓度(400倍临床使用浓度)下单次外用无刺激,连续外用6 d后,完整及皮损皮肤开始出现轻微红斑;连续外用14 d和末次给药72 h内,红斑均消失;受试部位皮肤病理切片显示最大浓度下表皮增厚约为空白对照组的2倍。参花外用颗粒临床使用浓度下未引起急性毒性反应,最大浓度下对肝脏存在潜在毒性,临床使用浓度及最大浓度下对豚鼠均无致敏作用。结论参花外用颗粒临床使用浓度下安全、无毒,当浓度增大到400倍临床使用浓度时,可引发皮肤轻微刺激,表皮厚度增大,且有潜在肝毒性。Objective It is to evaluate the safety of Shenhua external granules for skin application.Methods Through skin irritation test,acute toxicity test and skin hypersensitivity test on healthy guinea pigs,the skin irritation,acute toxicity and hypersensitivity of Shenhua external granules were observed.Results Shenhua external granules are not irritating to the intact and damaged skin of guinea pigs at clinical concentrations,and the highest concentration(400×clinical concentrations)was not irritating to a single external application.For highest concentration,after continuous external use for 6 days,the skin of the intact and damaged skin group began to be accompanied by slight erythema,continuous external use for 14 days,within 72 h of the last administration,the erythema disappeared,the skin irritation score was 0,and the skin pathological section of the test site showed that the epidermal thickening of the highest dose group was about 2 times that of the blank group.Besides,at clinical concentrations,it did not cause acute toxicity,and there was potential toxicity to the liver at the maximum dose;there was no sensitization to guinea pigs at the clinical concentrations and at the maximum concentration.Conclusion Shenhua external granules are safe and non-toxic at the clinical concentrations.When the concentration is increased to 400 times of the clinical use,it can cause slight irritation to the skin,increase the thickness of the epidermis,and has potential liver toxicity.

关 键 词：参花外用颗粒 皮肤刺激性 皮肤过敏性 急性毒性 安全性 

分 类 号：R-332[医药卫生]