便通凝胶贴膏的制备及药效学评价  

Preparation and pharmacodynamics of Biantong gel plaster

作　　者：王兴刚 付志丽 蓝俊 翟康元 朱艳华[3] WANG Xing-gang;FU Zhi-li;LAN Jun;ZHAI Kang-yuan;ZHU Yan-hua(Guizhou Nursing Vocational College,Guiyang 550025;Sichuan Shangrui Biomedical Co.,Ltd.,Chengdu 610000;Heilongjiang University of Chinese Medicine,Harbin 150040)

机构地区：[1]贵州护理职业技术学院,贵阳550025 [2]四川尚锐生物医药有限公司,成都610000 [3]黑龙江中医药大学,哈尔滨150040

出　　处：《中南药学》2024年第7期1698-1704,共7页Central South Pharmacy

基　　金：贵州护理职业技术学院硕士基金课题(No.gzhlyj2022-07);贵州省科技计划项目(No.黔科合基础-ZK[2023]一般126);黑龙江省中医药经典普及化专项课题(No.ZYW2202-080)。

摘　　要：目的优化便通凝胶贴膏的制备工艺并研究其对阳虚便秘模型大鼠的作用。方法采用单因素实验和L^(9)(3^(4))正交实验设计优化便通凝胶贴膏的制备工艺。将40只大鼠分为空白对照组、模型组、阳性对照组、贴膏组,除空白对照组外,其他各组动物采用“白醋+0℃冰水+复方地芬诺酯”灌胃的方法建立阳虚便秘模型;造模成功后,空白对照组和模型组大鼠灌胃等体积的生理盐水,阳性对照组大鼠给予市售的便通胶囊,每次灌胃1.2 g/200 g,每日两次;贴膏组贴敷制备的便通凝胶贴膏,每次贴12 h,贴于大鼠腹部;观察大鼠的一般生物学特征、粪便含水量及血清中胃泌素(Gas)、血管活性肠肽(VIP)、内皮素(ET)、胃动素(MTL)的含量。结果正交实验的最佳制备工艺为PVPK901.5 g、高岭土1.0 g、聚丙烯酸钠1.5 g、羧甲基纤维素钠0.5 g,经验证优化后的制备工艺稳定。与空白对照组比较,模型组大鼠的一般生物学特征、粪便含水量及血清中Gas、VIP、ET、MTL的水平均有显著差异,说明造模成功;给药后,阳性对照组与贴膏组各项指标均显著改善。结论优化的便通凝胶贴膏制备工艺可行,对阳虚便秘大鼠具有良好的治疗效果。Objective To optimize the preparation of Biantong gel plaster and determine its effect on model rats with yang deficiency constipation.Methods Single factor experiment and L^(9)(3^(4))orthogonal experiment design were used to optimize the preparation of Biantong gel plaster.Forty rats were divided into a blank control group,a model group,a positive control group and a plaster group.Except for rats in the blank control group,all rats in other groups were given white vinegar+0℃ice water+compound diphenoxylate intragastrically to establish the yang deficiency constipation model.After the model was successfully established,the rats in the blank control group and the model group were given the same volume of normal saline.While the positive control group was given commercial Biantong capsules(1.2 g/200 g,twice a day),and the plaster group was treated with Biantong gel plaster for 12 hours by sticking on the abdomen of the rats.The general biological characteristics,water content in feces and the levels of gastrin,vasoactive intestinal peptide,endothelin,motilin in the plasma were observed.Results The optimum preparation conditions included PVPK901.5 g,kaolin 1.0 g,sodium polyacrylate 1.5 g,and sodium carboxymethyl cellulose 0.5 g.The optimized preparation was verified to be stable.Compared with the blank control group,obvious differences were found in the biological characteristics,feces water content,and the levels of gastrin,vasoactive intestinal peptide,endothelin,motilin in plasma of rats in each modeling group,indicating successful modeling.After the drug administration,all the above indexes of the positive control group and the plaster group were obviously improved.Conclusion The optimized preparation of Biantong gel plaster is feasible and shows a good therapeutic effect on rats with yang deficiency constipation.

关 键 词：凝胶贴膏 阳虚便秘 便通凝胶贴膏 

分 类 号：R283[医药卫生—中药学] R285[医药卫生—中医学]