| 摘要: |
| 目的：建立湖南时代阳光药业股份有限公司小儿扶脾颗粒的高效液相色谱法（HPLC）指纹图谱分析方法。方法：采用反相高效液相色谱法，Ulimate-XB C18色谱柱（4.6mm×250mm，5μm），乙腈-0.1%磷酸溶液梯度洗脱，柱温30℃，检测波长330nm。结果：以橙皮苷为参照峰，建立了小儿扶脾颗粒HPLC指纹图谱，确立了12个共有峰，10批样品之间的共有峰相似度>0.9。结论：该方法准确，精密度、重复性较好，可作为湖南时代阳光药业股份有限公司小儿扶脾颗粒质量控制的依据。 |
| 关键词: 小儿扶脾颗粒 高效液相色谱法 指纹图谱 |
| DOI： |
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| A fingerprint analysis of Xiaoer Fupi granules |
| GUAN Zhi-mei,PENG Yan-mei,GONG Nian-chun |
| (Hunan Center for Drug Evaluation and ADR Monitoring，Changsha 410013，Hunan，China;Institute of Material Medica，Hunan Academy of Chinese Medicine，Changsha 410013，Hunan，China) |
| Abstract: |
| Objective：To establish the high-performance liquid chromatography（HPLC) method for the fingerprint analysis of Xiaoer Fupi granules manufactured by Hunan Timesun Pharmaceutical Co.，Ltd.Methods：Reversed-phase HPLC was performed on an Ulimate-XB C18 column（4.6 mm×250mm，5μm) with acetonitrile-0.1% phosphoric acid solution for gradient elution at a column temperature of 30℃ and a detection wavelength of 330nm.Results：The HPLC fingerprint of Xiaoer Fupi granules was established with hesperidin as the reference peak，and a total of 12 common peaks were identified.The similarity of the common peaks of 10 batches of samples was higher than 0.9.Conclusion：This method is accurate and has good precision and repeatability.Therefore，it can be used as the basis for the quality control of Xiaoer Fupi granules manufactured by Hunan Timesun Pharmaceutical Co.，Ltd. |
| Key words: Xiaoer Fupi granule high-performance liquid chromatography fingerprint |
