目的建立抗脑衰胶囊色谱指纹图谱,并对关键成分进行测定,作为抗脑衰胶囊制剂质量评价的依据。方法采用HPLC法。色谱条件:Kromasil ODS C18柱(250mm×4.6mm,5μm),甲醇-0.6%醋酸水溶液系统梯度洗脱,体积流量0.9mL/min,检测波长280nm,柱温25℃。采用标准曲线法对其中葛根素、黄芩苷、芍药苷进行测定。结果指纹图谱中28个共有吸收峰为抗脑衰胶囊内在物质的指纹特征,方法学考察的精密度、稳定性、重现性试验较好。不同批次抗脑衰胶囊指纹图谱的相似度评价和指标成分有差异。结论定量测定与特定指纹图谱分析相结合方法可作为评价抗脑衰胶囊制剂质量的标准。

Objective To establish chromatographic fingerprint and quantitative analysis of Kangnaoshuai Capsula by HPLC method for evaluating the quality of the preparation Methods Theoptimal HPLC condition for Kangnaoshuai Capsula:ODS C18 column(250 mm X 4.6 mm,5弘m),themobile phase was composed of methanol and 0.6% acetic acid with a linear gradient elution,the flow ratewas 0.9 mL/min with DAD detected at 280 nm,the column temperature was maintained at 25℃.Quantitative analysis of paeoniflorin,puerarin,and baicalin were carried Out by the standard curve as acontr01.Results Total of shared 28 chromatographic peaks were determined as inner characters ofKangnaoshuai Capsula.The methodological studies indicated that this HPLC fingerprint is of highprecision,strong repeatability and good stability；The similarity and content from various batches of samples showed some differences.Conclusion The method can be used scientifically and effectively tOevaluate the quality of Kangnaoshuai Capsula.