基于标准汤剂的吴茱萸配方颗粒制备工艺研究OA

Objective To study the preparation technology of Fructus Euodiae Formula Granule(吴茱萸配方,FEFG)based on its standard decoction.Methods After preparing Fructus Euodiae(FE)standard decoction,using extraction rate,transfer rates of limonin,evodiamine,and rutaecarpine as evaluation indicators,and taking water volume,extraction time,and extraction cycles as influencing factors,orthogonal experiments were conducted to optimize the extraction process and investigate concentration temperature,drying method,and excipient ratio to refine the formula granule preparation.Results The optimal extraction process involves using 8 times the amount of water for two extractions,each lasting 1.5 h.The optimal concentration process is vacuum concentration at 70℃ or below for no more than 9 h.The optimal drying process requires a concentrated liquid density of 1.03-1.05 g/cm³ followed by spray drying.With the addition of 0％-7％ excipients,dry granulation is performed.Both the extract yield and content of various components are essentially consistent with those of the standard decoction.Conclusion This study optimized the production process of FEFG using standard decoc-tion as the quality benchmark,thereby ensuring the quality consistency between the formula granules and traditional FE decoction.The optimized process guarantees the safety,efficacy,stability,and controllability of clinical medication,while providing novel technical approaches for the preparation of FE and other Chinese herbal formula granules.