| Objective:In this study, the effective external preparation which named Pi-Fu Nian-Mo Xiao-Yan San (Pi-Nian San) was selected as the research object, and then the therapeutic effects and mechanisms of Pi-Nan San on chronic skin ulcer as well as the anti-inflammation and external use safety of Pi-Nan San were evaluated.Method:Firstly, the chronic skin ulcer rat models were established to evaluate the therapeutic effects of Pi-Nian San. Then we determined the change of ulcer area, wound color, secretion, granulation tissue of all chronic skin ulcer rats. Furthermore, the epidermal growth factor (EGF) and basic fibroblast growth factor (bFGF) expression of skin ulcer tissues were examined by immunohistological staining. Moreover, the histopathological examination of skin ulcer tissues were used to confirmed the therapeutic effects of Pi-Nian San on chronic skin ulcer rats.Secondly, the anti-inflammation effect of Pi-Nian San was tested in xylene-induced ear edema model of mice.Finally, acute dermal toxicity, skin irritation and dermal sensitivity tests were used to investigated the safety of external application of Pi-Nan San.Results:1.1Ulcer area:On the2,4,8days, positive control group and high dose group had significant difference compared with model control group (p<0.05-0.01); On the4,8days, there was significant difference between the low dose group and model control group (p<0.01)1.2Ulcer colour and lustre:On the2,4,8days, there was no significant difference among the positive control group, high dose group, low dose group and model control group (p>0.05)1.3Ulcer secretion and smell:On the2,4,8days, there was no significant difference among the positive control group, high dose group, low dose group and model control group (p>0.05)1.4New granulation tissue:On the8days, positive control group and high dose group had significant difference compared with model control group (p<0.05)1.5Pathology observation:Compared with the model control group, the positive control group and the conditions of skin ulcer healing in Pi-Nian San hand less inflammatory reactions, granulation tissue growing well and low degree of fiber hyperplasia.1.6Immunohistochemistry staining was used to detection:There was significant difference among the four groups(p<0.05～0.01),which meant EGF、bFGF expression in the granulation tissue of model control group was inferior than the other groups.2The anti-inflammatory effect:Compared with the model control group, there was significant difference between the two groups (p<0.05),which means Pi-Nian San could significantly reduce the xylene-induced ear edema in mice, which showed an anti-inflammation effect.3Preliminary safety tests:The results of preliminary safety tests indicated that Pi-Nian San did not cause skin acute toxicity, irritation and sensitization, which indicated that Pi-Nian San possessed a higher external use safety.Conclusion:Pi-Nian San showed a good repairing effect on chronic skin ulcer in rats, and its mechanisms may be related to the promotion of EGF and bFGF expressions, and acceleration the growth of granulation tissue and neovascularization. |
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