医院制剂益气解毒丸工艺及质量标准研究  

Study on The Technology and Quality Standard of Yiqi Jiedu Pills in Hospital

作　　者：陈礼大 吴增光 黎豫川 杨波 CHEN Lida;WU Zengguang;LI Yuchuan;YANG Bo(The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guizhou 550025,China)

机构地区：[1]贵州中医药大学第二附属医院,贵州550025

出　　处：《中国民族民间医药》2024年第16期35-41,共7页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：贵州中医药大学第二附属医院青苗科研启动基金,合同书GZEYK-[200]28号。

摘　　要：目的:对益气解毒丸的工艺、质量进行研究,优选生产工艺参数,建立质量控制方法。方法:制备工艺从饮片干燥温度、炼蜜等进行参数筛选,以水分、成型、浸出物等内容作为指标成分考察;以三批中试样品进行质量研究,参照丸剂的质量要求,从性状、鉴别、检查、浸出物等方面对益气解毒丸进行质量研究,采用薄层层析色谱法(TLC)对黄芪、土茯苓、淫羊藿、当归进行制剂的鉴别研究;筛选了浸出物的测定条件。结果:黄芪、土茯苓、淫羊藿、当归的薄层斑点清晰,圆整,阴性制剂无干扰。性状、水分、重量差异、装量、微生物限度均符合要求。浸出物测定条件适宜。结论:该制剂工艺简洁易操作、稳定,可用于制剂生产;质量研究方法稳定可行,重复性好,操作简单、方便,适用于益气解毒丸的质量控制。Objective To study the technology and quality of Yiqi Jiedu pills,optimize the production process parameters and establish a quality control method.Methods The preparation technology was screened from the drying temperature and honey refining,and the contents of moisture,molding and extract were used as the index components,according to the quality requirements of pills,the quality of Yiqi Jiedu pills was studied from the aspects of character,identification,examination and extract,radix astragali,Smilax glabra,herba epimedii and Angelica sinensis were identified by TLC,and the extraction conditions were selected.Results The thin layer spots of astragalus membranaceus,Smilax glabra,herba epimedii and Angelica sinensis were clear and round,and the negative preparation had no interference.Character,moisture,weight difference,loading capacity and microbial limit all meet the requirements.The conditions for the determination of extract were suitable.Conclusion the preparation process is simple,stable and suitable for the quality control of Yiqi Jiedu pills,and the method is stable and feasible with good repeatability.

关 键 词：益气解毒丸 工艺研究、质量研究 薄层色谱 浸出物 

分 类 号：R283.6[医药卫生—中药学]