小儿热速清颗粒UPLC指纹图谱及5种成分含量测定研究
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摘要
目的:研究提高小儿热速清颗粒的质量控制方法。方法:采用超高效液相色谱(ultra performance liquid chromatography,UPLC)法建立小儿热速清颗粒的指纹图谱。色谱柱为ZORBAX Eclipse Plus C_(18)柱(100 mm×2. 1 mm,1. 7μm),流动相为甲醇(A)-0. 05%磷酸水(B),梯度洗脱,柱温:40℃,流速:0. 4 m L·min-1,检测波长:240 nm。结果:12批小儿热速清颗粒样品指纹图谱相似度在0. 988～0. 999,共有20个共有峰,并指认其中5个共有峰。5种成分在各自范围内线性关系良好(r> 0. 999 0),平均加样回收率在97. 90%～103. 25%,RSD在1. 96%～2. 75%。结论:该方法简便可靠,重复性好,可用于小儿热速清颗粒的质量控制。
Objective: To establish a method for the quality control of Xiaoer Resuqing granules. Methods:A ultra performance liquid chromatography( UPLC) method was developed to establish the fingerprint of Xiaoer Resuqing granules. The separation was performed on ZORBAX Eclipse Plus C18( 100 mm × 2. 1 mm,1. 7 μm)column,and gradient elution was performed with mobile phase consisting of methanol( A)-0. 05% phosphoric acid( B) at a flow rate of 0. 4 m L·min-1. The column temperature was 40 ℃ and the detection wavelength was set at240 nm. Results: The similarity of the fingerprints of 12 batches of Xiaoer Resuqing granules was between 0. 988 and 0. 999. There were 20 common peaks in total and five of them were identified. The calibration curves of the five constituents showed good linear relationships within the respective ranges( r > 0. 999 0),and their average recoveries were 97. 90% ～ 103. 25% with RSDs of 1. 96% ～ 2. 75%. Conclusion: This simple,reliable and reproducible method can be used for the quality control of Xiaoer Resuqing granules.
Objective: To establish a method for the quality control of Xiaoer Resuqing granules. Methods:A ultra performance liquid chromatography( UPLC) method was developed to establish the fingerprint of Xiaoer Resuqing granules. The separation was performed on ZORBAX Eclipse Plus C18( 100 mm × 2. 1 mm,1. 7 μm)column,and gradient elution was performed with mobile phase consisting of methanol( A)-0. 05% phosphoric acid( B) at a flow rate of 0. 4 m L·min-1. The column temperature was 40 ℃ and the detection wavelength was set at240 nm. Results: The similarity of the fingerprints of 12 batches of Xiaoer Resuqing granules was between 0. 988 and 0. 999. There were 20 common peaks in total and five of them were identified. The calibration curves of the five constituents showed good linear relationships within the respective ranges( r > 0. 999 0),and their average recoveries were 97. 90% ～ 103. 25% with RSDs of 1. 96% ～ 2. 75%. Conclusion: This simple,reliable and reproducible method can be used for the quality control of Xiaoer Resuqing granules.
引文
[1]国家药典委员会.中华人民共和国药典[S]. 2015年版.第一部.北京:中国医药科技出版社,2015:549.
[2]周建良,齐炼文,李萍.色谱指纹图谱在中药质量控制中的应用[J].色谱,2008,26(2):153-159.
[3]谢培山.中药色谱指纹图谱鉴别的概念、属性、技术与应用[J].中国中药杂志,2001,26(10):653-655.
[4]程巧鸳,郑成,郑瑜倩,等.小儿热速清颗粒质量标准研究[J].医药导报,2017,36(3):321-325.
[5]史宏妍,潘成学. HPLC法同时测定小儿热速清颗粒中绿原酸和黄芩苷的含量[J].中国药房,2012,23(16):1531-1532.
[6]韦建荣.《中国药典》中药材指纹图谱研究文献统计分析[J].时珍国医国药,2009,20(5):1289-1290.
[7]祝明,陈碧莲,石上梅.中药指纹图谱技术在中国药典2015年版一部中的应用[J].中国现代应用药学,2016,33(5):611-614.
[8]郑雅楠,廖茂梁,孙卫,等.龙加通络胶囊UPLC与HPLC指纹图谱的比较[J].中国实验方剂学杂志,2015,21(21):66-69.
[9]王常顺,刘永利,冯丽.知柏地黄丸的UPLC指纹图谱研究[J].中国现代应用药学,2017,34(10):1432-1436.
[10]姚令文,刘燕,郑笑为,等.指纹图谱、特征图谱技术在中药材和中成药中的应用[J].中国新药杂志,2018,27(8):934-939.
[2]周建良,齐炼文,李萍.色谱指纹图谱在中药质量控制中的应用[J].色谱,2008,26(2):153-159.
[3]谢培山.中药色谱指纹图谱鉴别的概念、属性、技术与应用[J].中国中药杂志,2001,26(10):653-655.
[4]程巧鸳,郑成,郑瑜倩,等.小儿热速清颗粒质量标准研究[J].医药导报,2017,36(3):321-325.
[5]史宏妍,潘成学. HPLC法同时测定小儿热速清颗粒中绿原酸和黄芩苷的含量[J].中国药房,2012,23(16):1531-1532.
[6]韦建荣.《中国药典》中药材指纹图谱研究文献统计分析[J].时珍国医国药,2009,20(5):1289-1290.
[7]祝明,陈碧莲,石上梅.中药指纹图谱技术在中国药典2015年版一部中的应用[J].中国现代应用药学,2016,33(5):611-614.
[8]郑雅楠,廖茂梁,孙卫,等.龙加通络胶囊UPLC与HPLC指纹图谱的比较[J].中国实验方剂学杂志,2015,21(21):66-69.
[9]王常顺,刘永利,冯丽.知柏地黄丸的UPLC指纹图谱研究[J].中国现代应用药学,2017,34(10):1432-1436.
[10]姚令文,刘燕,郑笑为,等.指纹图谱、特征图谱技术在中药材和中成药中的应用[J].中国新药杂志,2018,27(8):934-939.