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机构地区:[1]鲁南制药集团股份有限公司,山东临沂276006 [2]中药制药共性技术国家重点实验室,山东临沂276006 [3]山东省中药制药新技术重点实验室,山东临沂276006
出 处:《中国药房》2014年第3期256-259,共4页China Pharmacy
基 金:国家重点基础研究发展计划(973计划)项目资助课题(No.2010CB735604)
摘 要:目的:建立红参超微粉的质量标准。方法:采用薄层色谱(TLC)法鉴别样品;使用激光粒度分析仪对样品粒径进行检测;以高效液相色谱法同时测定样品中人参皂苷Rg1、人参皂苷Re、人参皂苷Rb,的含量:色谱柱为Kromasil C18(250mm×4.6mm,5μm),流动相为乙腈-水(梯度洗脱),检测波长为203nm。结果:样品TLC图中斑点清晰,可鉴别出与对照品对应的斑点;红参超微粉的中位粒径在20gm以下;人参皂苷Rg1、人参皂苷Re、人参皂苷Rb。的进样量分别在1.043-10.430、1.079~10.790、1.139~11.390gg范围内与各自峰面积积分值呈良好线性关系(r均为0.9999);平均加样回收率分别为100.27%、100.52%、100.28%,RSD分别为1.44%、1.95%、1.08%(,2均为6)。结论:所建立的方法简便、准确、重复性好,可用于红拳超微粉的质量控制。OBJECTIVE: To develop a quality standard for Red Ginseng ultra-micro powder. METHODS: Qualitative analysis of Red Ginseng ultra-micro powder was carried out by TLC. The particle diameter was detected with laser scattering particle size distribution analyzer. HPLC was used for the content determination of ginsenoside Rg1, ginsenoside Re and ginsenoside Rb1. Kromasil C,8(250 mm×4.6 mm, 5 μm) column was used with mobile phase consisted of acetonitrile-water(gradient elution). The detection wavelength was set at 203 nm. RESULTS: TLC spots were clear and counterpart of substance control could be identified. Median particle size of Red Ginseng ultra-micro powder was below 20 p.m. The linear ranges of ginsenoside Rg1, ginsenoside Re and ginsenoside Rb1 were 1.043-10.430 μg(r=0.999 9), 1.079-10.790 μg(r=0.999 9), 1.139-11.390 ktg(r=0.999 9). Average recoveries were 100.27% (RSD= 1.44%, n=6), 100.52% (RSD= 1.95%, n=6) and 100.28% (RSD= 1.08%, n=6). CONCLUSIONS : The method is simple, accurate and repeatable. It can be used for the quality control of Red Ginseng ultra-micro powder.
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