注射用葛根素的质量标准研究

Quality standard for Puerarin for Injection

目的 :建立注射用葛根素 (PF)的质量标准。方法 :采用高效液相色谱法测定含量和检查有关物质。结果 :本法能有效检查有关物质 ,最低检出量为 0 .1ng。在 1.5～ 10 μg·mL-1范围内 ,葛根素浓度与峰面积有良好的线性关系 (r =0 .9999) ;重复性RSD为 1.3% ;平均回收率为 99.7% ,RSD为 0 .3%。结论 :该法准确、灵敏 ,结果可信 ,适用于注射用葛根素的质量控制。

Objective: To establish the quality standard for Puerarin for Injection (PF). Methods : HPLC was used to determine puerarinum content and test its related compounds. Results : The method can test related compounds with a detection limit of 0.1ng. There is a good linearity in the range of 1.5～10μg·mL -1 of puerarin. The average recovery was 99.7% and RSD was 0.3%, respectively. Conclusion : The method is suitable for the quality control of PF.