Safety Study of Polyisobutylene Gutong Plaster by Transdermal Administration / 中国药房

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 af-ter transdermal administration. Another 60 rabbits were divided into several groups as above except for a normal group. A single pri-mary 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 (vase-line),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 obvi-ous toxicity symptoms could be seen after administration of PIB Gutong plaster. The rabbits’intact or damaged skin had no irrita-tion 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 trans-dermal administration.