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目的建立黄葵胶囊的HPLC指纹图谱,为本产品及其生产工艺过程质量控制提供有效方法与依据。方法采用高效液相色谱法。色谱条件:Thermo scientific Hypersil GOLD(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.2%磷酸水溶液为流动相进行梯度洗脱,流速0.8 mL.min-1,波长360 nm,柱温30℃。对原料、半成品、成品分别进行指纹图谱测定,并比较分析三者的相似度及相关性。结果 10批黄葵胶囊与其共有模式之间相似性良好,相似度均在0.95以上。黄葵胶囊原料、半成品、成品指纹图谱相关性较好。结论所建立的HPLC指纹图谱方法有较好的重现性,可有效地用于黄葵胶囊生产过程的质量控制和产品的质量评价。
Objective To establish the HPLC fingerprinting of Huang Kui Capsule, providing an effective method and basis for the quality control of this product and its production process. Methods Using high performance liquid chromatography. Chromatographic conditions: A gradient of acetonitrile-0.2% phosphoric acid in water was used as the mobile phase of a Thermo Scientific Hypersil GOLD (4.6 mm × 250 mm, 5 μm) column with a flow rate of 0.8 mL.min-1 and a wavelength of 360 nm. . The raw materials, semi-finished products, finished products were measured fingerprints, and comparative analysis of the three similarity and relevance. Results 10 batches of Huang Kui capsule and its common pattern of good similarity between the similarity of 0.95 or more. Huang Kwai capsule raw materials, semi-finished products, finished fingerprints correlation is good. Conclusion The established method of HPLC fingerprinting has good reproducibility and can be effectively used in the quality control of Huangkui capsule production process and product quality evaluation.