壮腰健肾丸质量标准研究  

Study on Quality Standard for Zhuangyao Jianshen Pills

作　　者：王秀芹[1] 吕渭升 林彤[1] 

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《中药新药与临床药理》2016年第6期855-859,共5页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家药典委员会课题2013年药品标准修订品种(297)

摘　　要：目的建立壮腰健肾丸的质量控制方法。方法：采用薄层色谱（TLC）法对壮腰健肾丸中狗脊、黑老虎、桑寄生、女贞子进行定性鉴别;采用高效液相色谱（HPLC）法对壮腰健肾丸中特征性成分特女贞苷进行含量测定。结果在TLC色谱图中可检出狗脊、黑老虎、桑寄生、女贞子的特征斑点,且各斑点清晰,易于观察。特女贞苷在0.119~2.963μg范围内进样量与其峰面积线性关系良好（r=0.999）。平均加样回收率为96.1%,RSD=1.1%（n=6）。该方法精密度、稳定性和重复性良好。结论本文所建立方法简便、准确、稳定且无干扰,可作为壮腰健肾丸的质量控制方法。Objective To establish the method for the quality control of Zhuangyao Jianshen Pills.Methods Rhizoma Cibotii（Gouji）,Radix Kadsurea Coccineae（Heilaohu）,Herba taxilli（Sangjishen） and Fructus Ligustri Lucidi（Nuzhenzi） of Zhuangyao Jianshen Pills were identified by thin layer chromatography（TLC）.The content of specnuezhenide the specific component in Fructus Ligustri Lucidi（Nuzhenzi）,was determined by high performance liquid chromatography（HPLC）.Results Rhizoma Cibotii（Gouji）,Radix Kadsurea Coccineae（Heilaohu）,Herba taxilli（Sangji shen） and Fructus Ligustri Lucidi（Nuzhenzi）could be detectable by TLC and the spots were clear for observation.In the range of 0.119-2.963 μg,specnuezhenide showed a good linear relationship to peak area（r=0.999）.The average recovery was 96.1 % with RSD=1.1 %（n=6）.This method had good precision,stability and repeatability.Conclusion The established method is simple,accurate,reliable,reproducible and with strong specificity,which can be used for the quality control of Zhuangyao Jianshen Pills.

关 键 词：壮腰健肾丸 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]