中国药业2026，Vol.35Issue(12)：56-61,6.DOI:10.3969/j.issn.1006-4931.2026.12.010
芷倍散脐贴制备工艺优选及其稳定性初步研究
Optimization of Preparation Process for Zhibei San Umbilical Patch and Preliminary Stability Study
摘要
Abstract
Objective To optimize the preparation process of Zhibei San Umbilical Patch and to investigate its stability.Methods With the particle size,water addition amount,and honey addition amount as the investigation factors,and with the comprehensive score(moldability score+weight variation score)as the evaluation indicators,the Box-Behnken response surface methodology was used to optimize the preparation process of Zhibei San Umbilical Patch.The contents of evodiamine,rutaecarpine,and imperatorin in the formulation were determined by high-performance liquid chromatography(HPLC)method.The stability of the formulation was evaluated under room temperature[(25±2)℃]and refrigeration[(5±3)℃]conditions.Results The optimal preparation conditions were determined as follows:grinding to 100 mesh,adding 25%water and 50%refined honey(relative to the herbal material mass).The mean comprehensive score in the validation experiments was 17.33(RSD=3.33%,n=3).After 90 d of storage at room temperature,no significant changes were observed in the contents of evodiamine or rutaecarpine(P>0.05),while the imperatorin content decreased to 90%of its original value after 30 d.After 180 d of refrigeration,no significant changes were found in evodiamine or rutaecarpine(P>0.05),whereas the imperatorin content decreased to 90%of its original value after 90 d of refrigeration.Conclusion The optimized preparation process is stable,reasonable,and feasible.The effective shelf life of the formulation is 30 d at room temperature and 90 d under refrigeration.关键词
芷倍散脐贴/制备工艺/高效液相色谱法/Box-Behnken响应面法/稳定性Key words
Zhibei San Umbilical Patch/preparation process/HPLC/Box-Behnken response surface methodology/stability分类
医药卫生引用本文复制引用
方栋,王林艳,张蕾,李坤,姚东..芷倍散脐贴制备工艺优选及其稳定性初步研究[J].中国药业,2026,35(12):56-61,6.基金项目
江苏省泰州市中医药科技项目[TZ202315] （）
江苏省泰州市科技支撑计划(社会发展指导性)项目[SSF202400072] （社会发展指导性）
北京医学奖励基金会项目[YXJL-2025-0106-0106]. （）
