益视明目颗粒质量标准研究

The quality standard research for YI SHI MINGMU granules by HPLC method

目的建立益视明目颗粒的质量标准。方法用薄层色谱法(TLC)鉴别制剂中的枸杞子、丹参;用高效液相色谱法(HPLC)定量测定丹参素钠的含量。色谱柱:Kromasil C18柱(4.6 mm×150 mm,5μm);流速:0.4 ml/min;检测波长:280nm;柱温:30℃;进样量:10μl;流动相:甲醇-0.5%醋酸水溶液(10∶90)。结果薄层色谱斑点清晰可见、阴性干扰小,可用于鉴别益视明目颗粒中的枸杞、丹参;丹参素钠在2.00~60.00μg/ml范围内线性关系良好,r=0.999 7(n=6),平均加样回收率105.6%,RSD=1.60%。结论建立的方法简便、准确、可靠性高、重现性好,可作为控制益视明目颗粒质量的有效方法。

Objective To establish the quality standard for YI SHI MINGMU granules . Methods TLC method was used to identify Lycium barbarum L and Salvia miltiorrhiza . HPLC method was used to quantitatively analyze the concentration of Tanshinol sodium . The analysis was carried out on a column of Kromasil C18 （4 .6 mm ×150 mm ,5 μm）with a mobile phase of methanol and 0 .5 % acetic acid at the flow rate of 0 .4 ml /min. Column temperature was 30℃ . The detection wavelength was 280 nm . Results The linearity range of Tanshinol sodium was 2 .00？60 .00 Pg /ml, r2 = 0 .999 7（n= 6 ） ,with the average recoveries of 105 .62% , RSD - 1 .60% . Conclusion This method is accurate , simple, reliable and reproducible . It can be used for the quality control of YI SHI MINGMU granules .