大果木姜子配方颗粒的工艺研究  

Process research on the formula granules of Cinnamomum migao

作　　者：袁红飞 肖金超 周家华 黄勇[1] 李月婷[1] 迟明艳 郑林[1] YUAN Hong-fei;XIAO Jin-chao;ZHOU Jia-hua;HUANG Yong;LI Yue-ting;CHI Ming-yan;ZHENG Lin(State Key Laboratory of Functions and Applications of Medicinal Plants/Guizhou Provincial Key Laboratory of Pharmaceutics,Guizhou Medical University,Guiyang 550004,China;School of Pharmaceutical Sciences,Guizhou Medical University,Guiyang 550004,China;Guizhou Provincial Engineering Research Center for the Development and Application of Ethnic Medicine and Traditional Chinese Medicine,Guizhou Medical University,Guiyang 550004,China)

机构地区：[1]贵州医科大学省部共建药用植物功效与利用国家重点实验室/贵州省药物制剂重点实验室,贵阳550004 [2]贵州医科大学药学院,贵阳550004 [3]贵州医科大学民族药与中药开发应用教育部工程研究中心,贵阳550004

出　　处：《中国新药杂志》2025年第1期80-88,共9页Chinese Journal of New Drugs

基　　金：国家自然科学基金资助项目(U1812403);贵州省科技计划资助项目(黔科合平台人才-GCC[2023]036,黔科合平台人才-CXTD[2023]019,黔科合支撑[2022]重点022)。

摘　　要：目的:采用传统煎煮工艺提取大果木姜子,并同步保留其挥发油和水提有效部位,开展大果木姜子配方颗粒的制备工艺研究。方法:选择加水量、提取时间、提取次数为考察因素,以红景天苷等4个成分的含量、干膏率为评价指标,运用Box-Behnken响应面法优选大果木姜子的提取工艺。选择β-环糊精与油的比例、包合温度、包合时间为考察因素,以桉油精和对伞花烃含量、包合物收得率为评价指标,设计正交实验优选大果木姜子油β-环糊精的包合工艺。大果木姜子水提液经浓缩、干燥后,包合物按比例加入中间体中,干法制粒获得配方颗粒。结果:大果木姜子优选提取工艺为一煎加12倍水,二煎加10倍水,每次煎煮1 h,合并滤液,同时收集挥发油适量,经正交实验考察验证,最终加入挥发油8倍量的β-环糊精,在40℃下包合60 min,制得大果木姜子油β-环糊精包合物。将大果木姜子水提液在65℃减压浓缩至相对密度1.04~1.10,真空干燥、粉碎后得干浸膏中间体,加入生药量0.34%的包合物,干法制粒,即得大果木姜子配方颗粒。结论:该大果木姜子配方颗粒工艺条件稳定可行,可为大果木姜子配方颗粒的制备及产业化生产提供数据支撑。Objective:The traditional decoction process was used to extract Cinnamomum migao,and the effective part of volatile oil and water extraction was retained simultaneously.The preparation process of the formula granules of Cinnamomum migao was further studied.Methods:Taking water addition,extraction time and extraction times as the investigation factors,the contents of four components,such as salidroside,and the dry paste rate as evaluation indexes,the Box-Behnken response surface method was used to optimize the extraction process of Cinnamomum migao.Takingβ-cyclodextrin-oil ratio,inclusion temperature,and inclusion time as the factors to be investigated,the contents of eucalyptol and p-cymene and the yield of inclusion complexes as evaluation indexes,the inclusion process ofβ-cyclodextrin in Cinnamomum migao oil was optimized in orthogonal experiments.After the aqueous extract of Cinnamomum migao was concentrated and dried,the inclusion complex was added to the intermediate in proportion,and the formula granules were obtained by dry granulation.Results:The optimized extraction process of Cinnamomum migao was adding 12 times of water for 1st decoction and 10 times water for 2nd decoctions,cooking for 1 h each time,and then combining the filtrates,and collecting an appropriate amount of volatile oil at the same time.After orthogonal test investigation and verification,8 times the amount of volatile oil was finally added toβ-cyclodextrin.After coated for 60 min at 40℃,theβ-cyclodextrin inclusion complex of ginger oil was prepared.The aqueous extract of Cinnamomum migao was concentrated to a relative density of 1.04~1.10 under reduced pressure at 65℃,and the intermediate of the dry extract was obtained after vacuum drying and crushing.The formula granules of Cinnamomum migao were obtained by dry granulation after the crude drug amount of 0.34%inclusion complex was added.Conclusion:The process conditions of the formula granules were stable and feasible,which can provide data support for the preparation and indus

关 键 词：大果木姜子 配方颗粒 正交设计 响应面法 

分 类 号：R943[医药卫生—药剂学]