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1、2009年6月中成药June2009第31卷第6期ChineseTraditionalPatentMedicineVo.l31No.6决明降脂片质量标准研究申欣(湖南省怀化市药品检验所,湖南怀化418000)关键词:决明降脂片;TLC;大黄素;2,3,5,4-'四羟基二苯乙烯-2-O-B-D-葡萄糖苷;HPLC摘要:目的:建立决明降脂片(决明子、何首乌、桑寄生、茵陈等)的质量控制方法。方法:对决明降脂片中何首乌、桑寄生、茵陈、决明子进行薄层色谱鉴别。用HPLC法测定大黄素和2,3,5,4-'四羟基二苯乙烯-2-O-B-D-葡萄糖苷的含量,采用DikmaDiamonsilC
2、18柱,以甲醇-0.1%磷酸溶液(85B15)和乙腈-水(5B15)为流动相,流速为1.0mL/min,检测波长:254nm和320nm。结果:薄层色谱斑点清晰,阴性对照无干扰。大黄素进样量在0.1312~1.3120Lg范围内线性关系良好,r=0.9998,平均回收率为99.80%,RSD为1.17%(n=6);2,3,5,4-'四羟基二苯乙烯-2-O-B-D-葡萄糖苷进样量在0.5800~5.8000Lg范围内线性关系良好,r=0.9998,平均回收率为98.68%,RSD为1.36%(n=6)。结论:本法专属性强,准确度高,重复性好,可作为该产品质量控制方法。中图分
3、类号:R927.2文献标识码:A文章编号:1001-1528(2009)06-0877-05QualitystandardofJuemingJiangzhiTabletSHENXin(HuaihuaInstituteforDrugControl,Huaihua418000,China)KEYWORDS:JuemingJiangzhiTable;tTLC;emodin;2,3,5,4-'tetrahydroxydiphenylethylenic-2-O-B-D-gluco-side;HPLCABSTRACT:AIM:Toestablishthemethodforqualit
4、ycontrolofJuemingJiangzhiTablet(SemenCassiae,RadixPolygonimultiflori,HerbaTaxilli,HerbaArtemisiaescopariae,etc.).METHODS:RadixPolygonimultiflori、HerbaTaxilli、HerbaArtemisiaescopariae、SemenCassiaewereidentifiedbyTLC.HPLCmethodfordeterminingemodinand2,3,5,4-'tetrahydroxydiphenylethylenic-2-
5、O-B-D-glucosideinJuemingJiangzhiTabletwereestab-lished.ADikmaDiamonsilC18columnwasused,themobilephasesweremethano-l0.1%phosphatesolution(85B15)andacetonitrile-watersolution(5B15),respectively.Theflowratewas1.0mL/min.Thedetectionwave-lengthwasat254nmand320nm,respectively.RESULTS:Thespotson
6、theTLCplatewereclear.Thenegativecontrolsampledidnt'disturb.Agoodlinearitywasobtainedforemodinintherangeof0.1312-1.3120Lg,r=0.9998.Theaveragerecoverywas99.80%,RSD=1.17%(n=6).Agoodlinearitywasobtainedfor2,3,5,4-'tetrahydroxydiphenylethylenic-2-O-B-D-glucosideintherangeof0.5800-5.8000Lg,r=0.
7、9998.Theaveragerecoverywas98.68%,RSD=1.36%(n=6).CONCLUSION:Themethodsarespecific,accurateandreproducible,andcanbeusedforthequalitycontroloftheproduc.t决明降脂片收载于5卫生部药品标准中药成方首乌、桑寄生、茵陈、决明子进行定性鉴别,采用[1]制剂第八册6,由决明子、何首乌、桑寄生、茵陈等HPLC法对决明子、何首乌中的有效成分大黄素以七味药组成的中药复方制剂,具有降血脂,降血清胆及何
