五味护肝咀嚼片质量标准研究
Study on Quality Standard of Wuwei Hugan Chewable Tablets
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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。Abstract: 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 chromatography (TLC); the content of schisandrin， schisantherin B， schisantherin A， Deoxyschisandrin and Schisandrin B， are simultaneously 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 developed for simultaneous determination of five lignans are simple and valid. It can be used for comprehensively controlling quality of Wuwei Hugan Chewable Tablets.
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