三伏贴凝胶膏剂质量标准研究
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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: 2014年银川市科技发展计划(2014057) 收稿日期: 2016 - 04 - 01 作者简介: 刘军(1971-),男,宁夏银川人,主任药师,研究方向:医院制剂开发。E-mail:nxljj@163.com


The Study on Quality Standard of Dog-days Paste Cataplasm
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Yinchuan Hospital of Traditional Chinese Medicine, Yinchuan 750001, China

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    摘要:

    目的制定“三伏贴”凝胶膏剂的质量标准。方法采用薄层色谱法(TLC)对方中的麻黄、延胡索进行定性鉴别,运用高效液相色谱(HPLC)法对制剂中的芥子碱硫氰酸盐进行含量测定。结果TLC斑点清晰,分离度良好,阴性对照无干扰;芥子碱硫氰酸盐在0.0109~0.0872mg/mL与峰面积分值呈良好的线性关系(r=1.0000),平均加样回收率为98.33%,RSD=2.01%. 结论所建立的定性定量方法分离度好,简便,专属性好,可用于三伏贴凝胶膏剂的质量控制。

    Abstract:

    Objective To establish the quality standard of dog-days paste cataplasm. Methods Qualitative identification of Ephedra, Corydalis Rhizoma in the formula was carried out by thin-layer chromatography(TLC). High performance liquid phase chromatography(HPLC) was used for the content of sinapine thiocyanate in the preparation. Results TLC spots were clear and well-separated without negative interference, the line range of sinapine thiocyanate was 0.0109~0.0872mg/mL, respectively, with good linear relationship with the peak area integral value(r=1.0000), the average recovery rate was 98.33%, RSD was 2.01%. Conclusion The qualitative and quantitative method with good resolution and was simple, convinient, and reliable with good precision, It can be used for the quality control of dog-days paste cataplasm.

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