益肾坚骨丸质量标准提高研究  

Study on Improvement of Quality Standard of Yishen Jiangu Pills

作　　者：陈占功[1] 赵小伟[1] 吴剑坤[1] 夏雪竹 毛克臣[1] CHEN Zhangong;ZHAO Xiaowei;WU Jiankun;XIA Xuezhu;MAO Kechen(Dept.of Pharmaceutical,Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院药学部,北京100010

出　　处：《中国医院用药评价与分析》2021年第5期517-521,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：全国中药特色技术传承人才培训项目。

摘　　要：目的:提高益肾坚骨丸的质量标准。方法:对熟地黄、菟丝子、茯苓、山药和泽泻进行显微鉴别,对山茱萸、苍术和丹参进行薄层色谱鉴别,采用高效液相色谱法对制剂中的莫诺苷和马钱苷进行定量分析。结果:熟地黄、菟丝子、茯苓、山药和泽泻的显微鉴别特征明显,山茱萸、苍术和丹参的薄层鉴别色谱图斑点清晰。莫诺苷在0.368~0.828μg范围线性关系良好,r^(2)=0.9999(n=6),平均回收率达97.55%,RSD=1.57%;马钱苷在0.392~0.882μg范围线性关系良好,r^(2)=0.9999(n=6),平均回收率达97.29%,RSD=0.82%。结论:本方法全面、准确,有效提高了该制剂的质量控制水平。OBJECTIVE:To improve the quality standard of Yishen Jiangu pills.METHODS:To conduct microscopic identification on radix rehmanniae,semen cuscutae,poria,rhizoma dioscoreae and rhizoma alismatis,to preform thin-layer chromatographic identification on cornus officinalis,rhizoma atractylodis and salviae miltiorrhizae,and the high performance liquid chromatography was adopted to carry out quantitative analysis on monosidine and strychnine in the preparation.RESULTS:The characteristics of microscopic identification of radix rehmanniae,semen cuscutae,poria,rhizoma dioscoreae and rhizoma alismatis were obvious,the spots of thin-layer chromatograms of cornus officinalis,rhizoma atractylodis and salviae miltiorrhizae were clear.The morroniside showed good linearity in the range of 0.368-0.828μg,with r^(2)=0.9999(n=6),the average recovery was 97.55%,and the RSD=1.57%;strychnine showed good linearity in the range of 0.392-0.882μg,with r^(2)=0.9999(n=6),the average recovery was 97.29%,and the RSD=0.82%.CONCLUSIONS:This method is comprehensive and accurate,which has effectively improved the quality control of this preparation.

关 键 词：益肾坚骨丸 显微鉴别 薄层色谱法 高效液相色谱法 

分 类 号：R932[医药卫生—生药学]