软肝丸的质量控制  

The quality control of Ruangan wan

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作  者:周红[1] 杜士明[1] 余礼军[1] 

机构地区:[1]十堰市中医医院,湖北十堰442000

出  处:《中医临床研究》2011年第9期11-12,共2页Clinical Journal Of Chinese Medicine

基  金:湖北省卫生厅课题<软肝丸对肝炎;肝硬化的临床研究>被湖北省科技厅认定为湖北省重大科技成果;为使成果转化;现制定质量标准;向湖北省食品药品监督管理局申请制剂批准文号

摘  要:目的:对软肝丸进行质量控制。方法:采用薄层色谱(TLC)法对方中黄芪进行鉴别,采用HPLC法测定方中黄芪有效成分黄芪甲苷的含量。结果:TLC鉴别色谱特征斑点明显,HPLC法测定黄芪甲苷的含量在0.059-7.6μg内线性关系良好,平均回收率为96.93%,RSD为1.14%。结论:本方法建立的质量评价,方法简便,快速,且重现性好,可用于软肝丸的质量控制。Objective: To control the quality of Ruangan wan- Methods: The thin layer chromatography (TLC) was used to distinct the astragalus and the glycoside content of astragalus was determinated by HPLC- Results: The distinction of chromatography features spot by TLC was obvious, the linear range of astragalus glycoside was 0-059-7-6μg, its linear relationship was good and the average recycling rate was 96-93%, RSD was 1-14%- Conclusion: This method of quality evaluation was simple, rapid and its reproducibility was good which can be used for quality control of the Ruangan wan-

关 键 词:软肝丸 质量控制 黄芪甲苷 

分 类 号:R284-1[医药卫生—中药学]

 

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