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复方鹿角霜片的质量控制

     

摘要

目的 建立复方鹿角霜片的质量控制方法. 方法 采用薄层色谱法对制剂中鹿衔草、忍冬藤进行定性鉴别,采用高效液相色谱法测定忍冬藤中的马钱苷、当药苷,鹿衔草中的水晶兰苷的含量. 结果 定性鉴别薄层色谱斑点清晰,特征明显,专属性强;高效液相色谱法测定含量,专属性强,在范围内水晶兰苷、马钱苷、当药苷进样浓度与色谱峰面积均呈良好的线性关系(r>0.999),平均回收率分别为97.2%,98.4%,96.0%,RSD分别为1.4%,0.8%,0.8%. 结论利用薄层色谱法定性、高效液相色谱法定量,方法简便准确,重复性好,可有效控制复方鹿角霜片的质量.%Objective To establish a method of quality control for compound Cornu cervi degelatinatum tablets. Methods Thin layer chromatography ( TLC ) was used for qualitative identification of Lonicerae Japonicae Caulis and Pyrola Herba in the preparations. High performance liquid chromatography was used to determine the content of loganin and chiratin in Lonicerae Japonicae Caulis and monotropein in Pyrola Herba. Results The TLC spots were clear and specific in the qualitative identification.HPLC determined the content. In the concentration range, monotropein, loganin and chiratin had a good linear relationship with peak area (r>0.999).The mean recovery was 97.2%, 98.4% and 96.0%;RSD was 1.4%, 0.8% and 0.8%. Conclusion The present study employs TLC for quality control and HPLC for quantity control. The methods are simple and accurate, have good reproducibility, and can effectively control the quality of compound Cornu cervi degelatinatum tablets.

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