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调经活血胶囊质量标准研究
引用本文:彭飞城,丁野,郑金凤,李文莉.调经活血胶囊质量标准研究[J].海峡药学,2014,26(1):53-55.
作者姓名:彭飞城  丁野  郑金凤  李文莉
作者单位:彭飞城(湖南省食品药品检验研究院,长沙,410001);丁野(湖南省食品药品检验研究院,长沙,410001);郑金凤(湖南省食品药品检验研究院,长沙,410001);李文莉(湖南省食品药品检验研究院,长沙,410001);
基金项目:国家药典委员会编国家药品质量标准提高行动计划项目(项目编号:618)
摘    要:目的 提高完善调经活血胶囊质量标准.方法 采用薄层色谱法对丹参、熟地黄进行鉴别;采用高效液相色谱法测定赤芍中芍药苷含量,色谱柱为Agilent Zorbax-SB C18(250mm×4.6mm,5μm),流动相为甲醇-水(25:75),柱温:35℃,流速:0.8mL·min-1,检测波长:230nm.结果 薄层色谱斑点清晰,分离效果良好;芍药苷对照品在0.01201~2.156μg范围内线性关系良好(r=0.9996),平均回收率为96.61%,RSD为1.21% (n=9).结论 本法简便、可靠、准确,可用于该制剂的质量控制.

关 键 词:调经活血胶囊  质量标准  薄层色谱法  高效液相色谱法

Studies on quality standard for Tiaojing Huoxue Capsules
PENG Fei-cheng,DING Ye,ZHENG Jin-feng,LI Wen-li.Studies on quality standard for Tiaojing Huoxue Capsules[J].Strait Pharmaceutical Journal,2014,26(1):53-55.
Authors:PENG Fei-cheng  DING Ye  ZHENG Jin-feng  LI Wen-li
Institution:(Hunan Institute for Food and Drug ControI,Chan- gsha 410001, China)
Abstract:OBJECTIVE To improve quality standard of Tiaojing Huoxue Capsules. METHODS Salviae Milt- iorrhizae Radix et Rhizoma and Rehmanniae Radix Praeparata were identified by TLC;The content of peoniflorin in Paeoniae Radix Rubra was determined by HPLC. An Agilent Zorbax-SB Cls (4. 6 mm × 250 mm,5μm) column was eluted with mobile phase consisted of methanol-water(25:75 ) at the column temperature of 35℃. The flow rate was 0. 8mL · min-1 and detective wavelength was 230nm. RESULTS The spots in TLC were quite clear. The linear range of peoniflorin was within 0. 01201 ~ 2. 156μg( r = 0. 9996), the average recovery of peoniflorin was 96. 61% with RSD of 1.21% ( n = 9). CONCLUSION The established method is simple, reliable, accurate and can be used as the quality control of Tiaojing Huoxue Capsules.
Keywords:Tiaojing Huoxue Capsules  Quality Standard  TLC  HPLC
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