Study on irritation,anaphylaxis and acute toxicity of percutaneous administration of Wenjing Powder
Objective:To investigate the irritation,anaphylaxis and acute toxicity of percutaneous administration of Wenjing Powder.Methods:(1)Irritation test:4 New Zealand rabbits,half male and half female,were selected.One day before administration,the hairs on both sides of the symmetrical parts of the back of New Zealand rabbits were removed.Ac-cording to the self comparison between the left and right sides of the same body,the left side of the rabbit was the control side,and the right side was the administration side.The dose was 8 g/kg·d.Administration side:the prepared Wenjing Powder was evenly applied to the skin once a day for 14 consecutive days;control side:warm water was applied.The gen-eral physiological condition and skin erythema and edema of New Zealand rabbits were observed and scored every day after administration.On the 14th day,4 h after administration,New Zealand rabbits were killed by air embolization for gross ana-tomical observation,and the skin of the administration site was taken for HE staining to observe the skin histopathological changes.(2)Anaphylaxis test:18 guinea pigs,half male and half female,were randomly divided into control group,posi-tive group and Wenjing Powder group,with 6 in each group.Guinea pigs in each group were sensitized on the 1st,7th and 14th day,and were stimulated once on the 14th day after the last sensitization.The dosage of guinea pigs in Wenjing Powder group was 6 g/kg·d,1.0%C6H3N2O4Cl was applied to guinea pigs in positive group and warm water was applied to guinea pigs in control group.The skin erythema and edema of guinea pigs in each group were observed and scored at 1st h,1st d,2nd d and 3rd d after stimulation.The guinea pigs were killed by cervical dislocation after anesthesia for gross anatomical observation.(3)Acute toxicity test:40 rats,half male and half female,were randomly divided into control group and Wenjing Powder group,with 20 in each group.The administration dose of the rats in Wenjing Powder group was 6.3 g/kg·d,and the rats in control group were coated with warm water on both sides of the back.The changes of body mass of rats were recorded on the 1st,7th and 14th day after administration.The general condition of rats and the skin condition at the administration site were observed at 1st h,1st d,3rd and 14th day after administration.On the 14th day after administration,the rats were anesthetized and blood was collected from the aorta abdominalis for blood routine examination;the rats were killed by cervical dislocation and gross anatomical examination was performed.Results:In irritation test,erythema was occasionally observed on the skin of New Zealand rabbits on the side of administration without edema.HE staining showed clear skin structure and no in-flammatory cell infiltration on the administered and control sides of New Zealand rabbits.In the anaphylaxis test,the guinea pigs in the positive group had obvious allergic phenomenon,and the sensitization rate was 100%;while the guinea pigs in the control group and Wenjing Powder group had no allergic phenomenon,and the sensitization rate was 0.In the acute tox-icity test,the food intake and body mass of rats in both groups increased normally,and no death occurred during the whole administration period.No erythema and edema were found in the skin of rats,and no abnormal changes were found in the or-gans observed by gross anatomy.Compared with that of the control group,the mean erythrocyte volume of rats in Wenjing Powder group increased by blood routine test on the 14th day,and the difference was statistically significant(P<0.05).There was no statistical significance in other indexes between the two groups(P>0.05).Conclusion:Wenjing Powder has no irri-tation to skin and allergic reaction,and is safe for external use.
万方数据
维普
