朱红膏促进皮肤溃疡愈合的安全性研究

Safety Study on Zhuhong Ointment of Promoting Dermal Ulcer Healing

目的研究朱红膏促进皮肤溃疡愈合的安全性,为临床用药提供依据。方法 SD雄性大鼠66只随机分为皮肤破损组、溃疡模型组、凡士林基质组及朱红膏高(38.08 mg/kg)、中(19.04 mg/kg)、低(9.52 mg/kg)剂量组。皮肤破损组仅以刀片刮伤大鼠皮肤;溃疡模型组选择皮肤缺损+细菌感染+埋置异物法造模;朱红膏和凡士林基质组以纱条方式在大鼠造模创面上贴敷给药14 d,每日保证给药时间4 h,观察尿β-N-乙酰氨基葡萄糖苷酶(NAG)活性、尿视黄醇结合蛋白(RBP)含量及肾脏组织病理改变。结果与溃疡模型组比较,朱红膏各剂量组、凡士林基质组及皮肤破损组尿NAG活性未见明显差异(P>0.05),尿RBP含量显著升高(P<0.05,P<0.01),肾脏组织病理检查结果示,随着用药剂量的增加,肾脏组织病变有加重趋势,与皮肤破损组比较,朱红膏高剂量组有较明显病变(P<0.05),与溃疡模型组比较,朱红膏各剂量组、凡士林基质组及皮肤破损组肾脏病变未见明显差异(P>0.05)。结论朱红膏中剂量用药2周可认为基本安全,朱红膏高剂量用药2周有可能引起肾脏损伤。

Objective To study the safety of Zhuhong Ointment in promoting dermal ulcer healing and to provide the basis for clinical administration.Method Sixty-six male SD rats were randomly divided into the damaged skin group,ulcer model group,vaseline control group,and high-,middle-,low-dose Zhuhong ointment groups.Each group was treated by corresponding methods for 14 d.NAG and RBP contents in urine were taken as monitoring indexes,and the pathological morphology changes of kidney were observed. Results There was no significant difference in NAG content between Zhuhong Ointment groups and ulcer model group（P〉0.05）.The RBP content in ulcer model group was remarkably lower than other groups（P〈 0.05,P〈0.01）.Kidney pathological changes of high-dose Zhuhong ointment group were significantly increased than that of damaged skin group（P〈0.05）.Conclusion Middle dose of Zhuhong Ointment used for 2 weeks can be regarded as safe.High dose of Zhuhong Ointment used for 2 weeks may cause renal injury.