益脑康提取液指纹图谱的建立及4种成分含量的测定

目的：建立益脑康提取液的HPLC指纹图谱及其指标成分含量测定方法，结合指纹图谱和含量测定结果，为评价益脑康的质量提供依据。方法：采用HPLC法，建立10批益脑康提取液的HPLC指纹图谱，标定共有峰，并进行相似度评价；对采用对照品对比确认的盐酸益母草碱、阿魏酸、毛蕊异黄酮苷、芒柄花苷等4个成分进行含量测定，比较不同批次样品的质量差异。结果：10批益脑康提取液相似度均大于0.9，确定了22个共有峰，指认出峰5为盐酸益母草碱、峰8为阿魏酸、峰9为毛蕊异黄酮苷、峰18为芒柄花苷；4种成分在各自范围内线性关系良好（R²≥0.999 6），精密度、稳定性、重现性试验中的RSD均小于5%，平均加样回收率为99.00%~103.62%，10批益脑康提取液中4种成分的含量为0.703~1.099，0.918~2.428，0.258~0.475，0.112~0.222 mg·g^-1。结论：所建立的指纹图谱和含量测定方法准确可靠，重现性好，可用于益脑康提取液的质量控制，并为益脑康相关制剂开发与质量评价提供参考。

Establishment of fingerprint of Yinaokang extract and content determination of 4 components

OBJECTIVE To establish the HPLC fingerprint of Yinaokang extract and the method for determining the content of index components, and to provide the basis for evaluating the quality of Yinaokang combined with the fingerprint and content determination results.METHODS The HPLC fingerprints of 10 batches of Yinaokang extract were established by high performance liquid chromatography (HPLC). The common peaks were calibrated and the similarity was evaluated. The contents of four components including leonurine hydrochloride, ferulic acid, calycosin and formononetin confirmed by reference substance comparison were determined, and the quality differences among different batches of samples were compared.RESULTS The similarity of 10 batches of Yinaokang extract was greater than 0.9, and 22 common peaks were identified. Peak 5 was leonurine hydrochloride, peak 8 was ferulic acid, peak 9 was calycosin, and peak 18 was formononetin. The four components all had a good linear relationship in their respective range (R² ≥ 0.999 6). The RSDs of precision, stability and reproducibility experiments were less than 5%. The average recoveries were 99.00%-103.62%. The contents of four components in 10 batches of Yinaokang extract were 0.703-1.099, 0.918-2.428, 0.258-0.475 and 0.112-0.222 mg·g^-1, respectively.CONCLUSION The established fingerprint and content determination method are accurate, reliable and reproducible, which can be used for the quality control of Yinaokang extract, and provide reference for the development and quality evaluation of Yinaokang related preparations.