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宁心宝胶囊定性定量方法研究

Study on qualitive and quantitative methods of Ningxinbao capsules

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【作者】 张萍李远科肖新月林瑞超

【Author】 ZHANG Ping1,LI Yuan-ke2,XIAO Xin-yue1,LIN Rui-chao1 (1.National Institute for the Control of Pharmaceutical and Biological Products,Beijing 100050,China;2. Sichuan Ziyang Institute for Drugs Control,Ziyang 641300,China)

【机构】 中国药品生物制品检定所四川资阳食品药品检验所

【摘要】 目的:建立宁心宝胶囊的定性定量方法。方法:采用TLC法对该制剂中的游离麦角甾醇类成分及核苷类成分分别进行定性鉴别;采用HPLC法对3种核苷类成分尿苷、鸟苷及腺苷进行定量分析,色谱柱为Lichrospher C18(250mm×4.6mm,5μm)柱,流动相为甲醇-0.05moL·L-1磷酸二氢钾溶液(8∶92),流速1.0mL.min-1,检测波长260nm。结果:游离麦角甾醇类及核苷类成分的TLC定性鉴别专属性强。HPLC法测定的尿苷、鸟苷、腺苷3种核苷类成分的线性范围分别为0.13~1.90μg(r=0.9999,n=5),0.09~1.30μg(r=0.9999,n=5),0.08~1.21μg(r=0.9999,n=5);平均回收率(n=9)分别为100.8%,99.4%,100.9%。结论:本方法定性专属性强,定量准确可靠,方法操作简便,灵敏度高,可用于控制宁心宝胶囊的质量。

【Abstract】 Objective:To establish the quality and quantity methods of Ningxinbao capsules. Methods:Ergosterins and nucleosides in Ningxinbao capsules were identified by TLC. The contents of three nucleosides(uridine,guanosine,adenosine) in Ningxinbao capsules were determined simultaneously by HPLC.The chromatographic column was Lichrospher C 18 column(250 mm×4.6 mm,5 μm);The mobile phase was methanol-0.05 mol·L-1 potassium dihydrogen phosphate solution(8∶ 92) at the flow rate of 1.0 mL·min-1,and the detecting wavelength was 260 nm.Results:The method of identifying ergosterins and nucleosides was specific. The calibration curves were linear in the ranges of 0.13-1.90 μg(r=0.9999,n=5) for uridine,0.09-1.30 μg(r=0.9999,n=5) for guanosine,and 0.08-1.21 μg(r=0.9999,n=5) for adenosine;The average recoveries(n=9) were 100.8%,99.4% and 100.9% respectively. Conclusion:The method is specific,effective,sensitive and accurate. It can be used for quality control of Ningxinbao capsules.

【关键词】 宁心宝胶囊尿苷鸟苷腺苷薄层色谱法高效液相色谱法
【Key words】 Ningxinbao capsulesuridineguanosineadenosineTLCHPLC
  • 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2009年09期
  • 【分类号】R286.0
  • 【被引频次】3
  • 【下载频次】167
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