蒙药镇刺六味丸的质量标准研究

Mongolian“Zhen Ci Liu Wei wan”quality Standards

目的：建立蒙药镇刺六味丸质量标准研究方法。方法：采用薄层色谱法、高效液相色谱法进行处方中单药的专属性薄层色谱鉴别、有效成分士的宁的含量测定。色谱条件：Shim-pack VP-ODS 150L＊4.6;流动相：乙腈∶0.01mol/L庚烷磺酸钠与0.02mol/L磷酸二氢钾等量混合溶液（加10%磷酸调节p H值至2.8）=（21∶79）;检测波长：260nm;流速为1.0m L/min;柱温：室温;进样量：10μL。参照《中国药典》（2010版）进行了一般检查项目的研究。结果：采用薄层鉴别法对处方中的单味药进行鉴别研究,样品和对照品在薄层板相应的位置均出现相同的特征斑点,阴性对照品相应的位置没有出现干扰。用HPLC法测定该药中士的宁的含量,士的宁进样量在10~400μg时与峰面积呈良好的线性,平均回收率为100.54.%（RSD=2.06%）。结论：本研究采用的定性和定量分析方法简便、快捷、专属性和重复性好、结果准确可靠,为建立和完善蒙药镇刺六味丸的质量标准提供科学依据。

Objective： To establish a Mongolian ＂Zhen Ci Liu Wei wan＂quality standard research methods. Method： TLC,HPLC,AAS,Hitachi 835-50 amino acid analysis method for automatic prescription monotherapy specificity TLC,the active ingredient content determination of strychnine metal element composition analysis and determination of amino acid composition analysis. Chromatographic conditions： Shim-pack VP-ODS 150L＊4.6; mobile phase： acetonitrile-0.01mol/L and sodium heptane 0.02mol/L potassium dihydrogen phosphate solution by mixing equal amounts（10% phosphoric acid to adjust p H to 2.8） =（21∶79）; detection wavelength： 260nm; flow rate of 1.0ml/min; column temperature： room temperature; injection volume： 10μL. Refer to ＂Chinese Pharmacopoeia＂（2010 edition）conducted a general inspection of the project. Results： The TLC method of single herb prescriptions were identified studies,the sample and reference the corresponding position in the TLC plate exhibits the same characteristics are spots,negative control corresponding position does not appear interference. The drug was determined by HPLC content of strychnine strychnine injection volume of 10 ~400μg time and peak area showed good linearity,the average recovery was 100.54.%（RSD=2.06%）. Conclusion： The use of qualitative and quantitative analysis method is simple, fast, specific and reproducible, accurate and reliable, to establish and perfect the Mongolian Zhen Ci Liu Wei wan quality standards to provide a scientific basis.