臭牡丹提取物凝胶剂肛肠药效学及体外释药性研究

Study on Anorectal Pharmacodynamics and in vitro Drug Release of Paeonia Odorata Extract Gel

目的:采用正交试验和《中国药典》(2020版)四部通则0114凝胶剂质量检验法确定臭牡丹提取物凝胶剂的最优制备工艺,并对其肛肠药效学及体外释药性进行研究。方法:选取卡波姆940、丙二醇、无水乙醇为主要因素,采用正交试验方法,优化臭牡丹提取物凝胶剂制备工艺。采用冰乙酸(HAC)建立溃疡性痔疮小鼠模型,以马应龙麝香痔疮膏做对照,比较两组用药后创伤处的恢复情况,同时用猪小肠作为半透膜制成扩散池模拟肛门环境,进行体外释药性研究。结果:臭牡丹提取物凝胶剂外观细腻光滑、稳定性好,可有效治疗小鼠肛门溃疡,且体外释药速度快。结论:该配方合理,动物实验效果较为显著,可为溃疡性痔疮提供一种新的治疗方案。

Objective:To identify the optimized preparation process of the paeonia odorata extract gel by orthogonal experiment and Chinese Pharmacopoeia(2020),and conduct study of the anorectal pharmacodynamics and in vitro drug release for this drug product.Method:Carbomer 940,propylene glycol and anhydrous ethanol were selected as the main factors in the orthogonal test method to optimize the preparation process of paeonia odorata extract gel.Anal ulcer induced with acetic acid(HAC)in mice were made into animal models of ulcerative hemorrhoids,and take marolon haemorrhoid creams as the control drug.Compare the recovery of trauma after the drug application in the two groups.Diffusion pool made from pig intestine as a semipermeable membrane is used to simulate the environment to carry out in vitro drug release study.Results:The paeonia odorata extract gel was smooth and stable,and achieved good therapeutic effect on anal ulcer in mice with fast release.Conclusion:The formula is reasonable and effective in animal experiment,which can provide a new treatment option for ulcerative hemorrhoids.