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目的:建立驴胶补血颗粒的HPLC指纹图谱,为科学评价其质量提供依据。方法:Inertsil ODS2-C18色谱柱,流动相0.1%磷酸-乙腈组成的梯度洗脱液,检测波长215 nm,柱温30℃,流速1.0 mL.min-1,分析时间95 min;对12批样品进行测定,并进行相似度评价。结果:12批驴胶补血颗粒样品的HPLC指纹图谱有25个共有峰,相似度均在0.9以上,符合规定。结论:该方法稳定,可靠,可用于驴胶补血颗粒的质量控制。
Objective: To establish the HPLC fingerprint of donkey-glue-enriching blood particles and provide scientific basis for evaluating its quality. METHODS: Inertsil ODS2-C18 column, mobile phase, 0.1% phosphoric acid-acetonitrile gradient elution, detection wavelength 215 nm, column temperature 30 °C, flow rate 1.0 mL.min-1, analysis time 95 min; for 12 batches of samples Measurements were made and similarity evaluations were performed. RESULTS: There were 25 common peaks in HPLC fingerprints of 12 batches of donkey-glue-enriched blood particles, and the similarity was above 0.9, which was in accordance with regulations. Conclusion: This method is stable and reliable. It can be used to control the quality of donkey-glued blood particles.