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目的:对清胰颗粒进行质量标准的研究。方法:采用薄层色普法对制剂中的大黄进行定性鉴别,用大黄素为对照品,以石油醚(30～60℃)-甲酸乙酯-甲酸(15:5:1)的上层液为展开剂。采用高效液相色谱法对栀子中栀子苷进行含量测定,采用迪马钻石色谱柱(200mm×0.46mm)。流动相为:乙晴-水(15:85),检测波长为238nm,流速1.0mL/min。结果:3批清胰颗粒中含栀子苷(C17H24O10)1.3606～1.4927。平均加样回收率为98.88%,RSD为1.63%。结论:该法可作为该产品的质量控制方法。
Objective: To study the quality standard of Qingyi granule. Methods: Rhubarb was identified qualitatively by thin layer chromatography. The emodin was used as reference substance and the upper layer of petroleum ether (30-60 ℃) - ethyl formate - formic acid (15: 5: 1) Agent. The content of geniposide in gardenia was determined by HPLC, using Dima diamond column (200mm × 0.46mm). The mobile phase was acetonitrile-water (15:85), the detection wavelength was 238 nm and the flow rate was 1.0 mL / min. Results: Three batches of Qingyi granule contained geniposide (C17H24O10) 1.3606 ~ 1.4927. The average recovery was 98.88% with RSD of 1.63%. Conclusion: This method can be used as the product quality control method.