红景天标准汤剂及配方颗粒高效液相色谱特征图谱研究

HPLC Characteristic Chromatograms of Rhodiolae Crenulatae Radix et Rhizoma Standard Decoction and Formula Granules

目的建立红景天标准汤剂及配方颗粒的高效液相色谱(HPLC)特征图谱。方法采用HPLC法,色谱柱为Inert Sustain C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.04%磷酸水溶液(梯度洗脱),流速为1.0 mL/min,检测波长为278 nm,柱温为30℃,进样量为10μL。以红景天苷为对照,测定15批红景天标准汤剂及小试工艺、中试工艺制成配方颗粒的HPLC图谱,确定共有峰。比较标准汤剂与配方颗粒样品HPLC图谱中共有峰的异同。结果标准汤剂与配方颗粒样品HPLC特征图谱有5个共有峰,相对保留时间均在规定值的±5%以内。结论建立的HPLC特征图谱能更好地控制红景天标准汤剂及配方颗粒的质量。

Objective To establish the high-performance liquid chromatography (HPLC) characteristic chromatograms of Rhodiolae Crenulatae Radix et Rhizoma standard decoction and formula granules.Methods HPLC method was adopted,the chromatographic column was Inert Sustain C_(18)column (250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.04%phosphoric acid aqueous solution (gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 278 nm,the column temperature was 30℃,and the injection volume was 10μL.With salidroside as a reference,the HPLC chromatograms of 15 batches of Rhodiolae Crenulatae Radix et Rhizoma standard decoction and formula granules prepared by the lab-scale and pilot-scale process were determined to identify the common peak.The similarities and differences of the common peaks in the HPLC chromatograms of the standard decoction and the formula granule sample were compared.Results There were five common peaks in the HPLC characteristic chromatograms of the standard decoction and the formula granule sample,and the relative retention time was within±5%of the specified value.Conclusion The established HPLC characteristic chromatograms can better control the quality of Rhodiolae Crenulatae Radix et Rhizoma standard decoction and formula granules.