聚异丁烯骨通贴膏经皮肤给药的安全性研究 点击下载
论文标题: 聚异丁烯骨通贴膏经皮肤给药的安全性研究
英文标题:
中文摘要: 目的:研究聚异丁烯(PIB)骨通贴膏经皮肤给药的安全性。方法:取66只家兔随机分为正常组、完整皮肤组、破损皮肤组,后2组再分为PIB组,PIB骨通贴膏低、中、高剂量组,骨通贴膏组,经皮肤给药24 h后连续观察14 d进行急性毒性实验;另取家兔60只,除不设置正常组外分组方法同上,采用同体自身左右侧对比法单次给药6 h后,记录皮肤刺激反应,进行单次皮肤原发性刺激实验。取70只豚鼠随机分为阴性对照组(凡士林)、PIB组、阳性对照组(2,4-二硝基氯苯)、骨通贴膏组、PIB骨通贴膏低、中、高剂量组致敏给药后,进行皮肤致敏实验。结果:PIB骨通贴膏给药后家兔未见明显中毒表现;PIB、PIB骨通贴膏低、中剂量对完整皮肤和破损皮肤兔均未见刺激性反应,PIB骨通贴膏高剂量对完整皮肤兔未见刺激性反应,破损皮肤兔给药1 h后有轻度刺激性;除阳性对照组豚鼠过敏反应发生率为100%外,其他各组过敏反应发生率均为0。结论:PIB骨通贴膏经皮肤给药安全性较好。
英文摘要: OBJECTIVE: To investigate the safety of Polyisobutylene (PIB) Gutong plaster by transdermal administration. METHODS: 66 rabbits were randomly divided into a normal group, a group with intact skin and a group with damaged skin. The latter two groups were respectively re-divided into PIB group, the groups of low, medium and high-dose PIB Gutong plaster and Gutong plaster group. An acute toxicity test was conducted on the rabbits, which 14 d of continuous observation was made 24 h after transdermal administration. Another 60 rabbits were divided into several groups as above except for a normal group. A single primary skin irritation test was conducted on them, where skin irritation reactions were recorded 6 h after a single administration based on intra-individual left/right self comparison method. 70 guinea pigs were randomized into a negative control group (vaseline), a PIB group, a positive control group (2,4-dinitrochlorobenzene), a Gutong plaster group and the groups of low, medium and high-dose PIB Gutong plaster, which were dosed for sensitization, followed by a skin sensitization test. RESULTS: No obvious toxicity symptoms could be seen after administration of PIB Gutong plaster. The rabbits’ intact or damaged skin had no irritation response to PIB and low and medium-dose PIB Gutong plaster. PIB Gutong plaster caused no irritation response in the rabbits’ intact skin, but slight irritation in damaged skin 1 h after administration. The allergic reaction incidence of the positive control group of guinea pigs was 100% while that of any other groups was 0. CONCLUSIONS: The PIB Gutong plaster is safe for transdermal administration.
期刊: 2016年第27卷第25期
作者: 杜婕莹,曾森,王璐,舒磊,张首亚,袁捷
英文作者: DU Jieying,ZENG Sen,WANG Lu,SHU Lei,ZHANG Shouya,YUAN Jie
关键字: 聚异丁烯;骨通贴膏;急性毒性实验;皮肤原发性刺激实验;皮肤致敏实验;安全性
KEYWORDS: Polyisobutylene; Gutong plaster; Acute toxicity test; Primary skin irritation test; Skin sensitization test; Safety
总下载数: 81次
本日下载数: 2次
本月下载数: 81次
文件大小: 619.60Kb

* 注:未经本站明确许可,任何网站不得非法盗链资源下载连接及抄袭本站原创内容资源!在此感谢您的支持与合作!