目的:建立龟鹿补肾丸的定性鉴别和定量测定方法。方法:采用TLC法对龟鹿补肾丸进行定性鉴别:用HPLC法测定该制剂中淫羊藿苷的含量。结果:薄层色谱法可鉴别出该制剂中的陈皮、黄芪、酸枣仁和淫羊藿。HPLC法含量测定中,淫羊藿苷的浓度在1～30μg·ml~(-1)范围内呈良好线性,样品的平均加样回收率为99.87%,RSD为2.5%。结论:建立的定性和定量方法均具有专属性好、准确和可靠的特点,可作为该制剂的质量控制方法。 Objective: To establish a qualitative identification and quantitative determination of Guilu Bushen Pills. Methods: The qualitative and differential identification of Guilu Bushen Wan by TLC method was used to determine the content of icariin in this preparation by HPLC. Results: Thin-layer chromatography identified the dried tangerine peel, Astragalus, Suanzaoren and Epimedium in this preparation. The content of icariin was linear in the range of 1 ~ 30μg · ml ~ (-1) by HPLC. The average recoveries of samples were 99.87% and the RSD was 2.5%. Conclusion: The established qualitative and quantitative methods are characterized by good specificity, accuracy and reliability, which can be used as the quality control method of the preparation.