五味护肝咀嚼片质量标准研究

王会娟; 毛春芹; 陆兔林; 王菊; 顾娟娟; 吴爽爽

五味护肝咀嚼片质量标准研究

南京中医药大学药学院，江苏南京 210023

计量
- 文章访问数: 621
- HTML全文浏览量: 3
- PDF下载量: 640
- 被引次数: 0
出版历程
- 收稿日期: 2012-11-17
- 修回日期: 2012-12-15
- 刊出日期: 2013-01-10

Study on Quality Standard of Wuwei Hugan Chewable Tablets

摘要

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。
- 五味护肝咀嚼片 /
- 质量标准 /
- 鉴别 /
- 含量测定
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.
- Wuwei Hugan Chewable Tablets /
- quality standard /
- identity /
- content determination

HTML全文

参考文献(16)

[1]	李家实.中药鉴定学[M].上海:上海科学技术出版社，1999: 377.
[2]	Li JS. Identificology of Chinese materia medica[M]. Shanghai: Shanghai science and technology press， 1999: 377.
[3]	国家药典委员会. 中华人民共和国药典：一部[S]. 北京: 化学工业出版社， 2010: 61-62.
[4]	National pharmacopoeia committee. Chinese pharmacopoeia[S]. Beijing: Chemical Industry Press，2010：61-62.
[5]	官艳丽，曹沛，郁开北，等. 北五味子化学成分的研究[J]. 中草药， 2006， 37(2): 185-187.
[6]	Guan YL， Cao P， Yu KB， et al. Studies on the chemical constituents from the fruit of Schisandra chinensis[J]. Chin Tradit Herb Drugs， 2006， 37(2): 185-187.
[7]	齐彦，郭丽新，周迎春，等. 五味子对四氯化碳所致小鼠急性肝损伤的作用研究[J].中医药学报，2009， 37(4): 26-27.
[8]	Qi Y， Guo LX， Zhou YX， et al. The effect of schisandra on mice which induced acute liver injury by CCl₄[J]. Acta Chin Med Pharm， 2009， 37(4): 26-27.
[9]	肖刚，熊富良，张良，等.高效液相色谱法测定五酯分散片中五味子酯甲含量[J].中国医院药学杂志，2007，27(10):1485-1486.
[10]	Xiao G， Xiong FL， Zhang L， et al. High performance liquid chromatographic method for the determination of five ester dispersible tablets of schisantherin a content[J]. Chin Hosp Pharm J， 2007， 27(10): 1485-1486.
[11]	丁佐，鲁巍巍，李宏博，等.HPLC同时测定北五味子中5种木脂素的含量[J].中国中药杂志，2010，35(13): 1728-1730.
[12]	Ding Z， Lu WW， Li HB. Determination of 5 kinds of lignans in Caulis Schisandrae chinensisby HPLC[J]. Chin Pharm J， 2010，35(13): 1728-1730.
[13]	胡俊扬，陆兔林，毛春芹，等.HPLC法同时测定不同产地五味子中8种木脂素类成分[J]，中成药，2012，34(2):313-316.
[14]	Hu JY， Lu TL， Mao CQ， et al. Determination of the ingredients of ligans with 8 kinds in schisandra chinensis produced in different areas[J]. Chin Pharm J， 2012，34(2):313-316.
[15]	潘新，刘霞，蔡敏芝. 五味子中五味子甲素的提取工艺研究[J]. 中成药， 2008， 30(6): 附2-3.
[16]	Pan X， Liu X， Cai MZ. The extraction technology research of Deoxyschisandrin in Schisandra[J]. Chin Tradit Patent Med， 2008， 30(6): appendix 2-3.