活血养阴颗粒质量标准研究

Study on the Quality Control Standard of Huoxue Yangyin Granules

摘要:

目的: 建立活血养阴颗粒的质量标准。 方法: 采用薄层色谱法对活血养阴颗粒中的葛根、益母草进行定性鉴别;采用HPLC对制剂中葛根素进行了含量测定,高效液相色谱条件Alltima C₁₈柱 (4.6 mm×250 mm,5 μm),流动相甲醇-0.3%磷酸溶液(26 ∶74),流速1.0 mL ·min^-1,检测波长250 nm,柱温35 ℃,以外标法计算含量。 结果: TLC色谱中能检出葛根、益母草;高效液相色谱测定葛根素在0.041 8~1.002 2 μg呈良好的线性关系,r=0.999 9,平均回收率 99.4%,RSD 1.4%(n=6)。 结论: 该法可准确地进行定性、定量,可有效地控制活血养阴颗粒的质量。

Abstract:

Objective: To establish the quality standard of Huoxue Yangyin granules composed of Herb Leonuri, Radix Puerariae Lobatae. Method: The quality of each raw material was identified by TLC. The quantity of the preparation was conducted by HPLC and the method was developed with the condition as follows: Alltima C₁₈ (4.6 mm×250 mm, 5 μm), mobile phase methanol-0.3% phosphoric acid (26 ∶74), the temperature of column 35 ℃, flow rate 1.0 mL ·min^-1, calculating the content with external standard method. Result: Herb Leonuri, Radix Puerariae Lobatae could be detected by TLC. Puerarin was linear in a range of 0.041 8~1.002 2 μg (r=0.999 9). The average recovery was 99.4%, and RSD was 1.4% (n=6). Conclusion: This method is simple, reliable, accurate, and can be used to control the quality of Huoxue Yangyin granules.