Study on Skin Irritation of Clobetasone Butyrate Cream in Rabbits and Its Skin Sensitization in Guinea Pigs / 中国药房

ABSTRACT

OBJECTIVE：To study the skin irritation and se nsitization of domestic generic drug Clobetasone butyrate cream ， and to compare it with commercial drug （original drugs ）. METHODS ：The skin irritation test was conducted on rabbits. Totally 24 rabbits were randomly divided into test preparation intact skin group ，test preparation abraded skin group ，commercial drug intact skin group and commercial drug abraded skin group ，with 6 rabbits in each group. 0.5 mL test preparation or commercial drug was administered to the left side of intact or abraded skin and the same amount of excipient on the right side of each rabbit twice a day for consecutive 7 days. The irritation of the drug to the rabbit skin was observed ，and the erythema and edema of the skin were scored；the skin of administration site was taken at 72 h after last administration and the end of 7 d after drug withdrawal for histopathological examination. The skin sensitization test （Buehler test ）was carried out on guinea pigs. Totally 60 guinea pigs were randomly divided into test preparation group （n＝20），commercial drug group （n＝20），positive control group （n＝10）and excipient control group （n＝10）. 0.2 mL test preparation or commercial drug was administrated to the left side of the rib abdomen skin of each guinea pig at the 0，7th，14th day to induce model ，and an equal amount of corresponding preparation was administered to the right side in the same way at the 28th day for stimulation. Hypersensitive response such as erythema and edema were observed and scored at 24 h and 48 h after the stimulation. The incidence of hypersensitive response was then calculated. RESULTS：In skin irritation test of rabbits ，no erythema and edema was caused by the test preparation or commercial drug on intact skin of rabbits ；scores of skin irritation was 0；there was no dermal irritation. Both test preparation and commercial drug caused transient slight erythema on abraded skin of a few rabbits ；scores of intact and abraded skin irritation were 0-0.33；there was no dermal irritation. There was no statistical significance among groups. No dermal pathological changes were observed. In skin sensitization test of guinea pig ，no hypersensitive response such as erythema and edema was found on the skin of guinea pigs in both test preparation and commercial drug groups ；both score and the incidence of hypersensitive response were 0. Compared with excipient control group ，there was no statistical significance of average score and the incidence of hypersensitive response in test preparation group and commercial drug group. CONCLU- SIONS：In skin irritation test of rabbits and skin sensitization test of guinea pigs ， the evaluation results of generic Clobetasone butyrate cream are the same as those of the original drug. It has no irritation to the skin of rabbit ，and no sensitization to the skin of guinea pigs.