不同贮藏条件下吴茱萸饮片稳定性考察  

Stability of Evodiae Fructus Decoction Pieces Under Different Storage Conditions

作　　者：罗干明 朱小凤 江珊 LUO Ganming;ZHU Xiaofeng;JIANG Shan(Foshan Food and Drug Inspection and Testing Center,Foshan,Guangdong,China 528000)

机构地区：[1]广东省佛山市食品药品检验检测中心,广东佛山528000

出　　处：《中国药业》2023年第23期80-83,共4页China Pharmaceuticals

基　　金：广东省药品监督管理局药品抽检计划[粤药监办执法〔2019〕51号]。

摘　　要：目的考察吴茱萸饮片的贮藏稳定性及指标性成分吴茱萸碱、吴茱萸次碱、柠檬苦素含量在不同干燥、光照、避光条件下的稳定性。方法分别采用牛皮纸袋、真空和非真空聚乙烯塑料袋包装12批吴茱萸饮片,分别在温度为16~17℃、相对湿度为50%~60%的药品阴凉柜中贮藏0~3年,按2020年版《中国药典(一部)》标准方法测定性状、水分、浸出物,并采用高效液相色谱法测定饮片中吴茱萸碱、吴茱萸次碱、柠檬苦素分别在0,60,80,105℃干燥,159 lx照射0,4,8,16,32 h,室温避光放置0,1,3,5 d条件下的含量。结果随着贮藏时间的延长,吴茱萸饮片的性状均无显著变化,水分为9.34%~14.13%,浸出物为42.75%~51.15%;吴茱萸碱和吴茱萸次碱的总含量为0.35%~5.02%,整体呈升高趋势;柠檬苦素含量为0.08%~1.81%,整体呈降低趋势,其中2批含量不符合标准规定(不得少于0.20%)。含量稳定性试验结果显示,吴茱萸碱、吴茱萸次碱、柠檬苦素在不同干燥及避光条件下的含量分别为0.94%~0.96%、0.56%~0.57%、0.52%~0.54%和0.96%~0.97%、0.57%~0.58%、0.52%~0.53%;吴茱萸碱、吴茱萸次碱、柠檬苦素在不同光照条件下的降解残存率分别为83.02%~100.00%、98.36%~100.00%、36.67%~100.00%。结论吴茱萸饮片在阴凉、避光条件下可贮藏较长时间,分析和开发含吴茱萸的制剂时应尽量避光操作。Objective To investigate the storage stability of Evodiae Fructus decoction pieces and the stability of the index components of evodiamine,rutaecarpine,and limonin content under different dry,light,and dark conditions.Methods Twelve batches of Evodiae Fructus decoction pieces were packaged in kraft paper bags,vacuum and non-vacuum polyethylene plastic bags,and stored in a cool cabinet with temperature of 16-17℃and relative humidity of 50%-60%for 0-3 years.The properties,moisture,and extracts of the decoction pieces were determined according to the standard methods in the Chinese Pharmacopoeia(2020 Edition,VolumeⅠ).High-performance liquid chromatography(HPLC)method was used to determine the content of evodiamine,rutaecarpine,and limonin in the decoction pieces dried at 0,60,80,and 105℃,irradiated with 159 lx for 0,4,8,16,and 32 h,and stored in dark at room temperature for 0,1,3,and 5 d.Results With the prolongation of storage time,there was no significant change in the properties of Evodiae Fructus decoction pieces,with moisture content of 9.34%-14.13%and extract content of 42.75%-51.15%.The total content of evodiamine and rutaecarpine was in the range of 0.35%-5.02%,showing an overall upward trend.The content of limonin is in the range of 0.08%-1.81%,showing a decreasing trend overall.Among them,the content of two batches did not meet the standard requirements(not lower than 0.20%).The results of the content stability test showed that the contents of evodiamine,rutaecarpine,and limonin under different dry conditions were in the ranges of 0.94%-0.96%,0.56%-0.57%,and 0.52%-0.54%,respectively,and those under different dark conditions were in the ranges of 0.96%-0.97%,0.57%-0.58%,and 0.52%-0.53%,respectively.The residual degradation rates of evodiamine,rutaecarpine,and limonin under different lighting conditions were in the ranges of 83.02%-100.00%,98.36%-100.00%,and 36.67%-100.00%,respectively.Conclusion Evodiae Fructus decoction pieces can be stored for a long time under cool and dark conditions.During the de

关 键 词：吴茱萸饮片 高效液相色谱法 吴茱萸碱 吴茱萸次碱 柠檬苦素 贮藏条件 稳定性 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0