人参皂甙Rh2产品质量检验及含量测定方法

研究了酶转化法生产人参皂甙Rh2产品一般质量检验 ,确定了符合药典规定的产品质量标准。建立了高效液相色谱法测定人参皂甙Rh2含量的方法。通过对高效液相色谱系统适用性实验、稳定性实验、精密度实验、重现性实验、回收率实验的讨论 ,可以确定一个准确的色谱条件用来测定人参皂甙Rh2的含量。其测定条件为流动相甲醇∶乙腈∶水为 8∶8∶1,流速 1mL/min ,紫外检测波长2 0 3nm ,色谱柱ThemoHypersilODS2 (2 5 0mm× 4 .5mm ,5 μm) ,回收率≥ 99.74 % ,平均标准偏差(RSD) <1.83% ,达到了药典规定。在该色谱条件下 ,人参皂甙Rh2的保留时间 8～ 10min。在流动相比例 (甲醇∶乙腈∶水 )改变 ,其他条件不变的情况下测定了人参皂甙Rh2的R型和S型的含量比例为 6∶4 ,R型保留时间为 17min左右 ,S型保留时间为 16min左右 ,R型在S型后面出峰。

Ginsenoside Rh2 quality detection and contents determination

We investigate the quality detection of Ginsenoside Rh2 and define the quality criterion conforming to that in the pharmacopodeia. We also proposed the method of systematic applicability test, stability test, precision test, reproducibility test, and determining the content of Ginsenoside Rh2. Conditions of HPLC system are listed as: fluid phase Methanol, Acetonitrile, Water= 8∶ 8∶ 1, speed 1?mL/min, UV 203?nm, the chromatic column, ThemoHypersil ODS2(250?mm×4.5?mm,5?μm),reproducibility ≥ 99.74% ,RSD<1.83%. Under these HPLC conditions, the remaining time of Ginsenoside Rh2 is 8 to 10 minutes. Under changed ratio of fluid phase and other HPLC conditions unvaried, the ratio of 20(R) Ginsenoside Rh2 to 20(s) Ginsenoside Rh2 is 6∶4. The remaining time of 20(R) Ginsenoside Rh2 is 17 minutes for R type and 16 minutes for S type, implying that 20(R) Ginsenoside Rh2 appears behind 20(s) Ginsenoside Rh2.