冰黄肤乐软膏体外抗炎抗菌及皮肤毒性评价研究

Research of evaluation on the anti-inflammatory and antibacterial efficacies and skin toxicity of Binghuang Fule Ointment in vitro

目的探讨冰黄肤乐软膏体外抗炎抗菌作用及皮肤毒性评价。方法评估冰黄肤乐软膏抗炎作用:SD大鼠和KM小鼠,随机分为模型组、基质组、皮炎平组、冰黄肤乐软膏低、中、高剂量组,测定足趾肿胀度、耳肿胀度和白细胞水平;评估冰黄肤乐软膏抗菌作用:将冰黄肤乐软膏样品进行梯度稀释,分别加入细菌或真菌50μl,确定该药物的最小抑菌浓度(MIC);皮肤刺激性及组织病理学:采用家兔皮肤自体对照方式,连续给药7 d,观察药物刺激强度,在观察期结束时取皮肤进行组织病理学检查。结果冰黄肤乐软膏在低、中、高剂量组各个时间点对大鼠足趾肿胀的影响与基质组和模型组比较,差异有统计学意义(P<0.01);冰黄肤乐软膏低、中、高剂量组对小鼠耳肿胀和白细胞水平的影响与基质组和模型组比较,差异有统计学意义(P<0.05);冰黄肤乐软膏对金黄色葡萄球菌、绿脓杆菌及白色念珠菌的MIC分别为:3.12~6.25、3.12~6.25、1.56~3.12 mg/ml,有显著抑制作用;冰黄肤乐软膏不具有皮肤刺激性。结论冰黄肤乐软膏具有很好的抗炎抗菌作用,同时无皮肤刺激性,证实其在临床用药中的有效性和安全性。

Objective To investigate the evaluation on the anti-inflammatory and antibacterial efficacies and skin toxicity of Binghuang Fule Ointment in vitro.Methods The anti-inflammatory efficacy of Binghuang Fule Ointment was evaluated:SD rats and KM mice were randomly divided into the model group,the stroma group,the Piyanping group and the Binghuang Fule Ointment in low,medium and high dose groups,and the toe swelling degree,ear swelling degree and white blood cell level were measured.The antibacterial efficacy of Binghuang Fule Ointment was evaluated;the samples of Binghuang Fule Ointment were diluted gradiently,and 50μl of bacteria or fungi were added respectively to determine the MIC of the drug.The skin irritation and histopathology were evaluated;rabbit skin was adopted by self-control method,the drug stimulation intensity was observed after continuous administration for 7 days,and at the end of the observation period,the skin was taken for histopathological examination.Results Compared with the stroma and the model group,the impacts of Binghuang Fule Ointment in low,medium and high dose groups on rat toe swelling degree at each time point were significantly different,with statistically significant differences(P<0.01).Compared with the stroma and the model group,the impacts of Binghuang Fule Ointment in low,medium and high dose groups on ear swelling degree and white blood cell level in mice were significantly different,with statistically significant differences(P<0.05).The MIC of Binghuang Fule Ointment on staphylococcus aureus,pseudomonas aeruginosa and candida albicans were 3.12-6.25,3.12-6.25 and 1.56-3.12 mg/ml,respectively,with significant inhibitory efficacies.Binghuang Fule Ointment had no skin irritation.Conclusion Binghuang Fule Ointment has good anti-inflammatory and antibacterial efficacies,and no skin irritation,which proves its effectiveness and safety in clinical medication.