补肾壮骨颗粒质量标准的研究

Study of the Quality Standard for Bushen Zhuanggu Keli

目的初步建立补肾壮骨颗粒的质量控制标准。方法采用TLC法对方中山茱萸、骨碎补进行定性鉴别;采用HPLC法测定方中淫羊藿中的淫羊藿苷,以乙腈-水(30:70)为流动相,流速为1.0mL/min,检测波长270nm,测定了3批补肾壮骨颗粒中淫羊藿苷的含量。结果在TLC色谱中可检出山茱萸、骨碎补;在HPLC色谱中,淫羊藿苷可与其他成分分离,且在0.0962～0.6734μg范围内与峰面积呈良好的线性关系,r2=0.9996,样品平均回收率为94.4%,RSD为1.8%(n=6)。结论所建立的方法对方中的3味药材可准确、快速的进行定性、定量检测,可用于补肾壮骨颗粒的质量控制。

Aim To establish a quality standard for Bushen Zhumtggu Keli.： Methods Icariin of Bushen Zhuanggu Keli was determined by HPLC. Fructus Corni and Rhizoma Drynariae were identified by TLC. The determination was carried out by HPLC with an Agilent HC18 （ 150mm ×4.6mm, 5 μm） column. Acctonitrila and water （ 30：70 ） were used as a mobile phase with the detection wavelength at 270nm. Results Icariin showed a good linear relationship within the range of 0.096 2 - 0.673 4μg（ r^2 = 0.999 6）. The average recovery of Icariin was 94.4% （ RSD = 1.8% , n =6）. Conclusion The results are stable with good reproducibility. This method is reliable, which can be used for quality control of the capsules.