消瘿散结颗粒工艺优化研究  

Optimization Study of Extraction and Preparation Technology of Xiaoying Sanjie Granules

作　　者：谢月[1] 吴宗彬[1] 邱绿琴[1] 刘翠玲 梅全喜 梁奇[1] XIE Yue;WU Zongbin;QIU Lyuqin;LIU Cuiling;MEI Quanxi;LIANG Qi(Shenzhen Bao'an Traditional Chinese Medicine Hospital Group,Shenzhen,Guangdong,China 518133)

机构地区：[1]广东省深圳市宝安区中医院,广东深圳518133

出　　处：《中国药业》2025年第6期46-51,共6页China Pharmaceuticals

基　　金：广东省深圳市医疗卫生三名工程项目[SZZYSM202206005];广东省深圳市中医药优秀人才培养项目[深卫健中医〔2021〕17号];广东省深圳市宝安区基础研究项目[2021JD152];广东省深圳市宝安区医疗卫生科研项目[2022JD215]。

摘　　要：目的优化消瘿散结颗粒的工艺。方法采用单因素试验法优选制剂中挥发油成分提取工艺;以芍药苷含量和干浸膏质量的综合评分为考察指标,以加水量、煎煮时间、提取次数为影响因素,采用L_(9)(3^(4))正交试验法优选制剂提取工艺;并考察浓缩、干燥及制剂工艺。结果挥发油成分最佳提取条件为加8倍量水,提取6 h;最佳提取工艺为煎煮2次,每次加水10倍量,提取2 h;最佳制剂工艺为采用减压浓缩,喷雾干燥(60℃下干浸膏相对密度控制在1.08~1.12),以麦芽糊精为填充剂;选择干式制粒法,物料含水量控制在3%~5%;临界相对湿度小于55%。结论优选的水提取工艺及制剂工艺稳定、可行,可有效保证制剂质量。Objective To optimize the process of Xiaoying Sanjie Granules.Methods The single-factor test method was used to optimize the extraction process of volatile oil components in the preparation.Taking the comprehensive score of paeoniflorin content and the quality of dry extract as the evaluation index,and the amount of added water,decoction time,and extraction times as the influencing factors,the L_(9)(3^(4))orthogonal test method was used to optimize the extraction process of the preparation.The concentration,drying,and preparation processes were also investigated.Results The optimal extraction conditions for volatile oil components were adding 8 times the amount of water and extracting for 6 hours.The optimal extraction process was decocting 2 times,adding 10 times the amount of water each time,and extracting for 2 hours.The optimal preparation process was using vacuum concentration and spray-drying(the relative density of the dry extract was controlled at 1.08-1.12 at 60℃),with maltodextrin as the filler.The dry granulation method was selected,and the water content of the material was controlled at 3%-5%,and the critical relative humidity was controlled below 55%.Conclusion The optimized water extraction process and preparation process are stable and feasible,which can effectively ensure the quality of the preparation.

关 键 词：消瘿散结颗粒 芍药苷 正交试验 提取工艺 制剂工艺 

分 类 号：R97[医药卫生—药品]