乳液压敏胶型狗皮膏的质量控制与初步药效学研究  

Quality Control and Preliminary Pharmacodynamics Study of Lotion Pressure Sensitive Adhesive Goupi Plaster

作　　者：颜茹 刘雨彤 薛云凤 柳嘉 王艳宏[1,2] YANG Ru;LIU Yutong;XUE Yunfeng;LIU Jia;WANG Yanhong(Heilongjiang University of Traditional Chinese Medicine,Harbin 150040,China;Key Laboratory of Basic and Applied Research at Beijing Pharmaceutical University,Ministry of Education,Harbin 150040,China)

机构地区：[1]黑龙江中医药大学,黑龙江哈尔滨150040 [2]北药基础与应用研究教育部重点实验室,黑龙江哈尔滨150040

出　　处：《特产研究》2025年第2期37-44,共8页Special Wild Economic Animal and Plant Research

基　　金：黑龙江省自然科学基金项目(LH2024H053);国家自然科学基金项目(82074025)。

摘　　要：本文旨在将传统狗皮膏提取的中药成分与现代新型制剂乳液压敏胶基质相结合,并对乳液压敏胶型狗皮膏进行质量控制、含量测定及药效学评价,验证其优良性能,为临床治疗膝骨关节炎提供更多选择。根据2020版《中国药典》对乳液压敏胶型狗皮膏的性状、黏附力、重量差异进行考察,并以桂皮醛、蛇床子素和青藤碱为考察指标,运用UPLC-MS/MS进行含量测定,最后建立家兔膝骨关节炎模型,通过ELISA法测定各组家兔关节腔液中IL-1 、MMP-13、TGF- 3个指标含量,并通过HE染色和番红固绿染色观察关节软骨病理形态。结果表明,乳液压敏胶型狗皮膏的质量检测符合要求,且对家兔完整及破损皮肤均无刺激。乳液压敏胶型狗皮膏中桂皮醛、青藤碱、蛇床子素的含量分别为(29.45±0.47)μg/g、(31.52±0.45)μg/g、(6.91±0.22)μg/g,且方法学考察结果良好。在乳液压敏胶狗皮膏作用下,家兔关节腔液中IL-1β、MMP-13、TGF-β含量显著下调(P <0.01),HE染色与番红固绿染色结果表明,给药组软骨结构基本完整,潮线清晰,番红着色深,基质降解现象减缓。本研究表明,现代新型制剂乳液压敏胶狗皮膏对家兔膝骨关节炎具有一定的改善作用,具有临床开发价值。The purpose of this study is to combine the traditional Chinese medicine ingredients extracted from the traditional Goupi plaster with the modern new preparation lotion pressure-sensitive adhesive matrix,and to conduct quality control,content determination and phar-macodynamic evaluation of the lotion pressure-sensitive adhesive Goupi plaster,to verify its excellent performance,and to provide more options for clinical treatment of knee osteoarthritis.According to the 2020 edition of Chinese Pharmacopoeia,the differences in the proper-ties,adhesion and weight of lotion pressure-sensitive adhesive Goupi plaster were investigated,and the contents of cinnamaldehyde,osthol and sinomenine were determined by UPLC-MS/MS,finally establishing a rabbit model of knee osteoarthritis.The contents of IL-1,MMP-13 and TGF-in the articular cavity fluid of rabbits in each group were determined by ELISA,and the pathological morphology of articular cartilage was observed by HE staining and safranine fixation green staining.The results showed that the quality test of lotion pres-sure-sensitive adhesive type Goupi plaster met the requirements,and there was no irritation to the intact and damaged skin of rabbits.The contents of cinnamaldehyde,matrine,and osthol in the hydraulic sensitive adhesive Goupi plaster are(29.45±0.47)μg/g,(31.52±0.45)μg/g,and(6.91±0.22)g/g,respectively.The methodological investigation results are good.Under the action of lotion pressure-sensitive adhes-ive Goupi plaster,the content of IL-1β,MMP-13,TGF-β in rabbit joint cavity fluid was significantly reduced(P<0.01).The results of HE staining and safranin green staining showed that the cartilage structure of the treated group was basically intact,with clear tide lines,deep safranin staining,and slight matrix degradation.This study shows that the modern new preparation lotion pressure sensitive adhesive Goupi plaster has a certain improvement effect on rabbit knee osteoarthritis,and has clinical development value.

关 键 词：乳液压敏胶狗皮膏 膝骨关节炎 质量检测 含量测定 药效学 

分 类 号：R285[医药卫生—中药学]