夏桑菊颗粒指纹图谱的建立及其在质量控制中的应用

Fingerprint of Xiasangju Granules and its application in quality control

目的:建立夏桑菊颗粒(夏枯草、桑叶、野菊花)HPLC指纹图谱,为中成药产品及生产工艺过程质量控制提供有效的方法。方法:Sunfrie C18,分析柱150 mm×4.6 mm,5μm;A相为1%醋酸,B相为甲醇组成的梯度洗脱液;检测波长为290 nm;柱温:30°C;流速1.0 mL/min;分析时间:65 min。对生产工艺中水煎液(A)、醇沉液(B)、浓缩液(C)、成品分别进行指纹图谱测定,进行比较。结果:10批夏桑菊颗粒指纹图谱相似度≥0.970。夏桑菊颗粒的水煎液(A)、醇沉液(B)、浓缩液(C)、成品进行指纹图谱有明显差异。结论:该方法稳定可靠,可以有效地用于夏桑菊颗粒生产过程的质量控制和产品的质量评价。

AIM： To establish an effective and convenient method for applying HPLC fingerprints to quality control in the production of Xiasangju Granules （ Spica prunellae, Folium mori, Flos chrysanthemi）. METHODS ： Komasil Sunfrie C18（150 mm ×4.6 mm,5 μm） analytical column was used and eluted with a gradient program consisted of phase A （1% acetic acid） and phase B （methanol） and detected at 290 nm. The fingerprints of aqueous extract, alcohol-precipitated extract, concentrate and finished product were compared with. RESULTS： The fingerprint method for Xiasangju Granules was established. The similarity among 10 batches of Xiasangju Granules was no less than 0. 970. The difference between extracts and finished product of Xiasangju Granules was obvious. CONCLUSION： This validated method is available for quality evaluation and quality control in Xiasangju Granule＇ s production.