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聚异丁烯骨通贴膏经皮肤给药的安全性研究
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| 篇名： | 聚异丁烯骨通贴膏经皮肤给药的安全性研究 |
| TITLE： | |
| 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。 |
| ABSTRACT： | 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 |
| AUTHORS： | 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 |
| 阅读数： | 514 次 |
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