Part Of The Safety Pharmacology Experimental Research About Han Li Xiao

Purpose:To testify the safety of Han Li Xiao as well as its further development and utilization, the experiments of acute toxicity, skin irritation and the skin allergy were performed on rabbit and guinea pig by dermic administration.Methods:1. Each12of healthy male and female rabbits were randomly divided into control (coating excipient), high dosage of Han Li Xiao (with intact and damaged skin) and low dosage of Han Li Xiao (with intact and damaged skin). Vasline, two and one piece of Han Li Xiao were administered to the rabbits in corrresponding group respectively, then death and toxic reaction of stigmata, edema, weight, skin and hair, change of eyes and mucous, breathing, central nervous system, limb activity, general state and behavior were observed after remove experimental drug in1,24,48,72hours and14days.2. Each8of healthy male and female rabbits were randomly seperated into intact and damaged skin excipient groups. Erythema and edema were observed and evaluated by contrasting the right and left part of a rabbit.3. Each15of healthy male and female guinea pigs were randomly divided into excipient and positive drug control group as well as planning group. The guinea pigs in corresponding group were senitized and aroused contact with vasline,2,4-dinitro-chlorobenzene (1%) and Han Li Xiao, then skin erythema and edema and other abnormal reactions were observed and evaluated after senitized for6and24hours as well as aroused for24,48,72hours.Result:1. After being administered in all the large, small dosage and blank group for24hours, erythema and edema caused by test compound were not observed in rabbits, and the administered skins were normal, and hair can grow in hair removal zone. The general state, behavior, physical sign, secretion, defecation, weight and life of the rabbits in these groups were normal.2. After being administered for6to72hours even to seventh day, erythema and edema were not observed in intact and damaged skin excipient groups, and the administered skins were normal, and hair can grow in hair removal zone. The general state, behavior, physical sign, of the rabbits in these groups were normal.3. After the first sensitization, erythema can be seen on the fur removal area in most of the animals (8) in the positive group, but edema did not happen, and the rate of sensitization was80%. After the second sensitization, moderate and severe erythema can be found on the fur removal area in most of the animals (8) in the positive group, but edema did not happen, and the rate of sensitization was80%. After the third sensitization, erythema can be detected on the fur removal area for all the animals in the positive group, but edema did not happen, and the rate of sensitization was100%. And one rabbit was dead for unknown reason. Erythema and edema was not observed in guinea pigs in both Han Li Xiao and excipient group, and systemic allergic reaction did not happen in both the goups.Conclusion:1. The obvious toxicity did not happen on the skin of rabbits which were administered by large dosage of Han Li Xiao in short term.2. It has no skin allergy when rabbits were administered by Han Li Xiao and its excipient alone.3. It has no skin allergy when Han Li Xiao was administered on the skins of guinea pigs.