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目的建立三勒浆口服液(SOL)的HPLC指纹图谱,测定其中主要成分量,为SOL的质量控制提供参考。方法采用Welchrom C18色谱柱(250 mm×4.6 mm,5μm),以0.1%磷酸水溶液-甲醇为流动相进行梯度洗脱,体积流量为1.0 m L/min,检测波长270 nm,柱温25℃,建立SOL的HPLC指纹图谱,并对没食子酸、没食子儿茶素、表儿茶素、柯里拉京和鞣花酸指标成分的定量测定进行方法学考察。结果在SOL特征指纹图谱研究中,共确定22个共有峰,同时利用相似度软件对10批SOL指纹图谱进行分析,各批次样品相似度在0.95以上;通过对比特征峰的保留时间,指认出5种主要成分,分别为没食子酸(3号峰)、没食子儿茶素(8号峰)、表儿茶素(15号峰)、柯里拉京(16号峰)和鞣花酸(21号峰);并且10批样品中没食子酸的量在5.743 2~7.538 0 mg/m L,没食子儿茶素的量在0.492 9~0.847 1 mg/m L,表儿茶素的量在0.529 7~0.8048 mg/m L,柯里拉京的量在0.937 5~1.756 5 mg/m L,鞣花酸的量在0.352 7~0.554 5 mg/m L。结论所建立的SOL HPLC指纹图谱和定量测定方法简单,分离效果较好,重复性好,实现了对SOL定性和定量的双重研究,可为其质量控制提供参考。
OBJECTIVE To establish HPLC fingerprints of SLE oral liquid (SOL) and determine the amount of its main components, providing references for the quality control of SOL. Methods The gradient elution was performed on a Welchrom C18 column (250 mm × 4.6 mm, 5 μm) using 0.1% phosphoric acid in methanol as the mobile phase. The volume flow rate was 1.0 m L / min. The detection wavelength was set at 270 nm and the column temperature was 25 ℃. The HPLC fingerprinting of SOL was established and the methodological study was carried out on the quantitative determination of gallic acid, epigallocatechin, epicatechin, corilagin and ellagic acid. Results A total of 22 common peaks were identified in the SOL fingerprinting study. At the same time, 10 batches of SOL fingerprints were analyzed using the similarity software, and the similarity of samples was above 0.95. By comparing the retention times of the characteristic peaks, The five main components were gallic acid (No.3), gallocatechin (No.8), epicatechin (No.15), Corilagin (No.16) and ellagic acid Peak); and the amount of gallic acid in 10 batches of samples was 5.743 2 ~ 7.538 0 mg / m L, the amount of gallocatechin was 0.492 9 ~ 0.847 1 mg / m L, the amount of epicatechin was 0.529 7 ~ 0.8048 mg / m L, the amount of corilagin is 0.937 5 ~ 1.756 5 mg / m L, and the ellagic acid is 0.352 7 ~ 0.554 5 mg / m L. Conclusion The established method of HPLC fingerprint and quantitative determination of SOL is simple, the separation effect is good, the reproducibility is good, and the double study of qualitative and quantitative determination of SOL is achieved, which can provide a reference for its quality control.