五味护肝咀嚼片质量标准研究  

Study on Quality Standard of Wuwei Hugan Chewable Tablets

作　　者：王会娟[1] 毛春芹[1] 陆兔林[1] 王菊[1] 顾娟娟[1] 吴爽爽[1] 

机构地区：[1]南京中医药大学药学院,江苏南京210023

出　　处：《南京中医药大学学报》2013年第1期71-74,共4页Journal of Nanjing University of Traditional Chinese Medicine

基　　金：国家科技部创新药物研究中药质量标准平台建设项目(2009ZX09308);江苏省教育厅重大项目(09KJA360001);江苏省高校优势学科资助项目(ysxk-2010);南京中医药大学中药学学科开放研究课题(2011ZYX2-003)

摘　　要：目的建立五味护肝咀嚼片的质量标准。方法采用薄层色谱法以五味子醇乙、五味子甲素和五味子对照药材为对照,对制剂进行鉴别;通过HPLC法同时测定制剂中五味子醇甲、五味子醇乙、五味子酯甲、五味子甲素和五味子乙素的含量。结果被测的5种木脂素成分分离度良好;各成分质量浓度与峰面积在测定范围内均呈良好线性关系(r>0.999 5);重现性良好;准确度(RSD)(n=9)分别为99.90%(1.63%)、99.42%(1.72%)、99.81%(2.07%)、99.79%(1.91%)和100.57%(1.61%);薄层图谱斑点清晰,空白无干扰。结论建立了专属性强的TLC鉴别和HPLC含量测定项目,方法简便易行,结果准确可靠,可较全面的控制五味护肝咀嚼片的质量。OBJECTIVE To establish quality standard of Wuwei Hugan Chewable Tablets. METHODS With chisantherin B, Deoxyschisandrin and Schisandra as control materials, Wuwei Hugan Chewable Tablet is identified by thin layer chromatog- raphy （TLC） ; the content of schisandrin, schisantherin B, schisantherin A, Deoxyschisandrin and Schisandrin B, are simulta- neously determinated by HPLC. RESULTS Excellent chromatographic separation was achieved in the five tested lignans with good linearity （r〉0. 999 5） over the studied concentration ranges. The average extraction recovery （RSD） （n= 9） was 99.90% （1.63%） for Schisandrin, 99,42%（1.72%） for Schisandrol B, 99.81%（2.07%） for Schisantherin A, 99.79%（1,91%） for Deoxyschisandrin and 100.57 % （1.61%） for Schisandrin B. CONCLUSION Specific, sensitive and reliable TLC identification and HPLC content determination of Wuwei Hugan Chewable Tablets were established. The TLC and HPLC methods devel- oped for simultaneous determination of five lignans are simple and valid. It can be used for comprehensively controlling quality of Wuwei Hugan Chewable Tablets.

关 键 词：五味护肝咀嚼片 质量标准 鉴别 含量测定 

分 类 号：R284.1[医药卫生—中药学]