补天灵片质量标准的研究

Quality Standard of Bulianling Tablets

目的研究补天灵片的质量标准。方法增加TLC法鉴别蛇床子及RP-HPLC法测定淫羊藿苷的含量。含量采用Waters C18色谱柱(200 mm×4.6 mm,5μm);流动相为乙腈-水(26︰74),流速1 ml·min-1;检测波长:270 nm;用外标法定量。结果鉴别、含量:阴性对照均无干扰;含量:0.050 52～2.526 0μg范围内有良好的线性关系(r=0.999 9),平均加样回收率为99.2%(n=6)。结论所建方法简单、可靠,可用于补天灵片的质量控制。

Objective To establish a method for the quality standard of Butianling Tablets. Methods TLC method was established for Fructus Cnidii and an RP-HPLC methed was established for the determination of Icariine on Waters C18 analytical column（200 mm×4.6 mm,5 μm） with Acetonitrile-water（26︰74） as the mobile phase.The flow rate was 1.0 ml·min-1,the detection wavelength was 270 nm. Results The linear range was 0.050 52～2.526 0μg（r=0.999 8）,and the average recovery（n=6）was 99.2%. Conclusion The method is convenient,reliable and suitable for quality assessment of Butianling Tablets.