复方藤芷凝胶贴膏剂制备工艺及透皮主要成分研究  

Research on the Preparation Process and Transdermal Main Components of Fufang Tengzhi Gel Plaster(复方藤芷凝胶贴膏剂)

作　　者：姜萌 郝淑兰 仝立国 冯玛莉 刘丽坤 王晞星 吉海杰 JIANG Meng;HAO Shulan;TONG Liguo;FENG Mali;LIU Likun;WANG Xixing;JI Haijie(Central Laboratory of Shanxi Institute of Traditional Chinese Medicine,Shanxi Traditional Chinese Medical Hospital,Taiyuan 030012,Shanxi,China)

机构地区：[1]山西省中医药研究院,山西省中医院,山西太原030012

出　　处：《辽宁中医药大学学报》2024年第9期57-63,共7页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：国家自然科学基金面上项目(81973672);山西省基础研究计划项目(202203021221291);山西省科技创新人才团队资助项目(202204051001032);山西省中医药创新工程项目(2023);山西省中医药管理局方药配伍及功用重点研究室项目(zyyyis2024023)。

摘　　要：目的为复方藤芷膏开发新剂型,并考察其透皮主要成分。方法以凝胶贴膏剂基质的感官评价、初黏力、持黏力为综合指标,以NP-700、甘羟铝、EDTA-2Na、甘油、PVPK-90、酒石酸、纯化水的使用量作为课题的主要考察因素。依次采用单因素设计实验法和正交设计实验法在不同材料用量配比下优选凝胶贴膏剂的最佳基质配方。基于超高效液相色谱-电喷雾离子源-四极杆飞行时间质谱联用技术(UPLC-ESI-QTOF-MS/MS),采用垂直Franz扩散池法进行透皮实验,检测复方藤芷凝胶贴膏剂的透皮主要成分并确定。结果复方藤芷凝胶贴膏剂的最佳配方为NP-7004.0 g,甘羟铝0.5 g,EDTA-2Na 0.2 g,二氧化钛2.0 g,甘油40 g,PVPK-905.0 g,酒石酸0.7 g,纯化水50 g,载药含量10%。透皮结果初步鉴定出3个化合物,包括大黄素、盐酸小檗碱及欧前胡素。结论研究所得复方藤芷凝胶贴膏剂膏体均匀,表面光滑,易于涂布。成型后具有优良的初始黏力和保持黏力,易剥离,无残留,保湿性好,对皮肤无刺激性和致敏性。透皮成分的确定为寻找其药效物质基础及进一步建立全面的质量控制方法提供了依据。Objective To develop a new dosage form for Fufang Tengzhi Gel Plaster(复方藤芷凝胶贴膏剂)and examinate of its transdermal main components.Methods The sensory evaluation,initial viscosity and holding power of the gel paste matrix were taken as comprehensive indexes,and the dosages of NP-700,aluminum glycinate,EDTA-2Na,glycerol,PVPK-90,tartaric acid and purified water were used as the main factors for this study.One-way design of experiments and orthogonal design of experiments were used sequentially to optimize the optimal matrix formulation of the gel paste with different material dosage ratios.Based on(UPLC-ESI-QTOF-MS/MS),transdermal experiments were carried out using the vertical Franz diffusion cell method to detect the transdermal major components of Fufang Tengzhi Gel Plaster and determine them.Results The optimal formulation of Fufang Tengzhi Gel Plaster was NP-7004.0 g,glycoaluminum 0.5 g,EDTA-2Na 0.2 g,titanium dioxide 2.0 g,glycerol 40 g,PVPK-905.0 g,tartaric acid 0.7 g,purified water 50 g,and the content of 10%of the drug.The transdermal results led to the preliminary identification of three compounds,including rhodopsin,berberine hydrochloride,and euoprostenol.Conclusion Fufang Tengzhi Gel Plaster obtained from the study had a uniform paste body,smooth surface and easy to spread.After molding,it has good initial adhesive force and adhesive strength,easy to peel and no residue when peeling,good moisturizing properties,no irritation and sensitization to the skin.The identification of the transdermal components provides a basis for searching for the material basis of its efficacy and further establishing a comprehensive quality control method.

关 键 词：复方藤芷膏 凝胶贴膏剂 基质配方优选 制备工艺 正交设计 体外透皮 液质联用 Franz扩散池法 

分 类 号：R244.9[医药卫生—针灸推拿学]