参桂鹿茸丸质量标准的拟定与提高

目的:建立参桂鹿茸丸质量标准。方法:采用显微特征法对杜仲、茯苓、酸枣仁、红花、香附、黄芩、砂仁等进行鉴别;采用薄层色谱法鉴别地黄;用HPLC法测定芍药苷的含量,色谱柱为Hypersil C18(BDS)柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(11∶89),流速为0.9 ml.min-1,检测波长为230 nm,柱温为30℃。结果:显微特征明显;薄层色谱斑点清晰;芍药苷在0.049～9.712μg范围内具有良好的线性关系(r=0.999 8),平均回收率为97.73%,RSD=2.2%(n=9)。结论:本法简便、可靠、准确,可用于该制剂的质量控制。

Establishment and Improvement of Quality Standard for Shengui Lurong Pills

Objective： To establish the quality standard for Shengui Lurong pills. Method： Microscopic characteristics were employed to qualitatively identify Eucommiae, Poria, Ziziphi Spinosae Semen, Carthami Flos, Cyperi Rhizoma, Scutellariae Radix and Amomi Fructus, and Rehmanniae Radix was identified by TLC. An HPLC method was applied to determine the content of paeoniflorin with the following conditions ： a Hypersil C18 （BDS） （ 250 mm ×4.6 mm,5μm） column, acetonitrile-water（ 11 ： 89） as the mobile phase, the column temperature of 30℃, the flow rate of 0.9 ml min-1 and the detective wavelength at 230 nm. Result： The microscopic characteristics were obvious and the TLC spots were quite clear. The linear range of paeoniflori was within 0.049-9. 712μg （r = 0.999 8 ）, and the average recovery was 97.73 % （ RSD = 2.2% , n = 9）. Conclusion ： The method is simple, reliable and accurate. It can be applied in the quality control of Shengui Lurong pills.