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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。
Objective: To establish the quality standard of GuiLi antler pill. Methods: Eucommia ulmoides, Poria cocos, Suanzaoren, safflower, Cyperus rotundus, Scutellariae Radix, Amomum villosum and so on were identified by microscopic characteristic method. The content of paeoniflorin was determined by TLC. The chromatographic column was Hypersil C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-water (11:89) at a flow rate of 0.9 ml · min-1. The detection wavelength was 230 nm and the column temperature was 30 ℃. Results: The microscopic features were obvious. The TLC spots were clear. Paeoniflorin showed a good linearity (r = 0.999 8) in the range of 0.049-9.712 μg with an average recovery of 97.73% and a RSD of 2.2% (n = 9) . Conclusion: This method is simple, reliable and accurate and can be used for the quality control of the preparation.