芷倍散脐贴制备工艺优选及其稳定性初步研究OA

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.