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目的:建立首当颗粒剂的质量控制方法.方法:用薄层层析法对其中的炒当归、补骨酯和陈皮进行定性鉴别,用高效液相色谱法对其中的指标成分大黄素进行了定量测定.紫外检测波长为λ436nm.结果:线性范围0.02～0.2μg,平均回收率为101.1%(n=5),RSD为1.20%.结论:鉴别和含量测定方法中各阴性对照品均无干扰,含量测定方法灵敏度高,重现性好,可作为该制剂的质量控制标准.
OBJECTIVE: To establish a quality control method for the first granules. METHODS: TLC was used to qualitatively identify the fried radix sinensis, bugu ester and dried tangerine peel, and the emodin, which is an indicator component, was subjected to high performance liquid chromatography. Quantitative determination. The UV detection wavelength was λ 436 nm. Results: The linear range was 0.02-0.2 μg. The average recovery was 101.1% (n=5) and the RSD was 1.20%. Conclusion: The negative control products in the identification and content determination methods did not interfere. The content determination method has high sensitivity and good reproducibility and can be used as the quality control standard of the preparation.