芪丹消渴胶囊质量标准研究
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银川市中医医院,宁夏 银川 750001

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R286.0

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* 基金项目: 银川市科技局立项项目(2014012) 收稿日期: 2016 - 09 - 20 作者简介: 李晓军(1978-),男,甘肃泾川人,副主任药师,主要从事医院制剂生产与研发。E-mail:lxj197811@163.com


The Study on Quality Standard of Qidan Xiaoke Capsule
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Yinchuan Hospital of Traditional Chinese Medicine, Yinchuan 750001, China

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    摘要:

    目的 制定芪丹消渴胶囊的质量标准。方法 采用薄层色谱法(TLC)对方中的黄芪、黄连进行定性鉴别,运用高效液相色谱(HPLC)法对制剂中的丹酚酸B进行含量测定。结果 TLC斑点清晰,阴性对照无干扰,分离度良好;丹酚酸B在0.2856~2.856μg范围内与峰面积分值呈良好的线性关系(r=0.9996),平均加样回收率为99.55%,RSD=0.965%. 结论 所建立的定性定量方法分离度好,重现性好,结果准确,可用于芪丹消渴胶囊的质量控制。

    Abstract:

    Objective To establish the quality standard of Qidan Xiaoke Capsule. Methods Qualitative identification of Astragalus, Rhizoma Coptidis in the formula was carried out by thin-layer chromatography(TLC). High performance liquid chromatography(HPLC) was used for the content of Salvianolic acid B in the preparation. Results TLC spots were clear and well-separated without negative interference, the line range of Salvianolic acid B was 0.2856~2.856μg, respectively, with good linear relationship with the peak area integral value(r=0.9996), the average recovery rate was 99.55%, RSD was 0.965%. Conclusion The qualitative and quantitative method with good resolution and was simple, convinient and reliable with good precision, which can be used for the quality control of Qidan Xiaoke Capsule.

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