白术通利胶囊的质量标准优化研究  

Study on the quality standard optimization of Baizhi Tongli capsules

作　　者：高媛[1] 巩伟[1] 吴洋[1] GAO Yuan;GONG Wei;WU Yang(Institute for Drug and Instrument Control, Joint Logistics Department of the Ji忆nan Military Region, Shandong Province,Ji'nan 250022, China)

机构地区：[1]济南军区联勤部药品仪器检验所,山东济南250022

出　　处：《中国当代医药》2018年第33期21-25,共5页China Modern Medicine

基　　金：军队医疗机构制剂标准提高科研专项课题(14Z JZ01-1;14ZJZ01-2)

摘　　要：目的对白术通利胶囊的质量标准进行提高和优化。方法鉴别项下,采用薄层色谱法分别对白术、川芎、补骨脂、泽泻和山楂进行鉴别;含量测定项下用高效液相色谱法(HPLC)测定白术中白术内酯Ⅰ的含量的含量,测定条件为色谱柱采用岛津ODS-VP3色谱柱,长250 mm,内径4.6 mm,粒径5μm;以甲醇-水(77∶23)为流动相;检测波长为276 nm,柱温35℃。结果薄层色谱鉴别斑点显色清晰,分离度号,灵敏度高,能有效鉴别出所需要鉴别的成分;含量测定白术内酯Ⅰ在4.0～16.0μg/ml的浓度范围内线性关系良好(r=0.9998,n=7),平均回收率为99.37%,RSD为0.84%(n=9)。结论白术通利胶囊的质量标准经提高后可用于其质量控制。Objective To improve and optimize the quality standard of Baizhu Tongli capsules.Mehtods In the identi-fication,Thin layer chromatography(TLC)was used to identify the Atractylodes Macrocephala,Ligusticum Chuanxiong,Psoralen,Alisma Orientalis and Hawthorn respectively.Under the content determination,the content of AtractylenolideⅠin Atractylodes Macrocephala was determined by high performance liquid chromatography(HPLC)method.The conditions were as follows:the chromatographic column used SHIMADZU ODS-VP3column,250mm long,inner di-ameter of4.6mm,and the particle diameter is5μm,and the methanol water(77∶23)was used as the method.The mo-bile phase was detected at276nm and the column temperature was35℃.Results The TLC identification spots had clear color,separation number,high sensitivity,and could effectively identify the components needed to identify.The content determination of AtractylodesⅠin the concentration range of4.0-16.0μg/ml was good(r=0.9998,n=7),the average recovery rate was99.37%(RSD=0.84%,n=9).Conclusion The improvement is easy-operated and accurate which has a good specificity for the quality control of Baizhu Tongli Capsules.

关 键 词：白术通利胶囊 质量标准提高 白术内酯Ⅰ 薄层色谱法 高效液相色谱法 

分 类 号：R283[医药卫生—中药学]