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目的:建立院內制剂生产采购黄芩药材的HPLC指纹图谱分析方法,为制剂內在质量评价积累数据。方法:采用HPLC方法,以SHIMADZU VP-ODS C_(18)色谱柱(150mm×4.6mm,5μm);流动相甲醇-0.2%磷酸水(47:53)等度洗脱;检测波长为280nm;柱温为30℃;流量为1.0ml·min~(-1),进样量:5μl。结果:建立黄芩药材指纹图谱,以5号色谱峰黄芩苷为参照峰,确定10个共有峰,测定了11批样品,样品指纹图谱相似度均大于0。8。结论:从整体上显示了购进的不同批次黄芩药材成分特征变化趋势,建立的HPLC指纹图谱方法为含黄芩的院內制剂质量控制提供有效手段。
OBJECTIVE: To establish an HPLC fingerprint analysis method for the production of Scutellaria baicalensis Georgi in hospital, and to accumulate the data for the evaluation of the intrinsic quality of the preparation. Methods: The HPLC method was used to elute isocratic elution with SHIMADZU VP-ODS C 18 column (150 mm × 4.6 mm, 5 μm), mobile phase methanol-0.2% phosphoric acid water (47:53) The temperature was 30 ℃; the flow rate was 1.0ml · min -1, the injection volume was 5μl. Results: The fingerprints of Radix Scutellariae were established. Based on the peak of baicalin of No. 5, 10 common peaks were identified, and 11 batches of samples were determined. The similarity of the fingerprints was higher than 0.8. CONCLUSION: The overall trend of the components of Scutellaria baicalensis Georgi purchased from different batches is shown. The established HPLC fingerprinting method provides an effective method for the quality control of Scutellaria baicalensis Georgi preparations.