HPLC测定小儿柴葛口服液原方中10种成分含量
投稿时间:2019-08-28     点此下载全文
引用本文:丁鹏敏,刘斯琪,庞月笙,王莎,玄振玉,张彤,王如峰.HPLC测定小儿柴葛口服液原方中10种成分含量[J].中国现代中药,2020,22(7):1118-1123
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作者中文名作者英文名单位中文名单位英文名E-Mail
丁鹏敏 DING Peng-min 北京中医药大学 生命科学学院,北京102488 School of Life Sciences,Beijing University of Chinese Medicine,Beijing 102488,China  
刘斯琪 LIU Si-qi 北京中医药大学 生命科学学院,北京102488 School of Life Sciences,Beijing University of Chinese Medicine,Beijing 102488,China  
庞月笙 PANG Yue-sheng 北京中医药大学 生命科学学院,北京102488 School of Life Sciences,Beijing University of Chinese Medicine,Beijing 102488,China  
王莎 WANG Sha 北京中医药大学 生命科学学院,北京102488 School of Life Sciences,Beijing University of Chinese Medicine,Beijing 102488,China  
玄振玉 XUAN Zhen-yu 苏州玉森新药开发有限公司,江苏苏州215007 Suzhou Youseen New Drug R&D Co.,Ltd.,Suzhou 215007,China  
张彤 ZHANG Tong 上海中医药大学 中药学院,上海201203 School of Pharmacy,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China 张彤,教授,研究方向:中药制药技术及体内过程;Tel:(021)51322318,E-mail:zhangtdmj@hotmail.comHPLC 
王如峰 WANG Ru-feng 北京中医药大学 生命科学学院,北京102488 School of Life Sciences,Beijing University of Chinese Medicine,Beijing 102488,China 王如峰,教授,研究方向:中药化学;Tel:(010)84738646,E-mail:wangrufeng@tsinghua.org.cn 
基金项目:国家科技重大专项(2019ZX09201004-002)
中文摘要:目的:建立小儿柴葛口服液原方中3′-羟基葛根素、3′-甲氧基葛根素、葛根素、芍药苷、芍药内酯苷、汉黄芩苷、黄芩苷、甘草苷、柴胡皂苷a、柴胡皂苷b2的含量测定方法。方法:采用Agilent TC-C18色谱柱(250 mm×4.6 mm,5 μm),流动相为乙腈(A)-0.1%磷酸水溶液(B),梯度洗脱,流速为1.0 mL·min-1,柱温为30 ℃,检测波长为230、210 nm。结果:该方法的专属性良好,精密度、重复性和稳定性的RSD均小于2%;3′-羟基葛根素、3′-甲氧基葛根素、葛根素、芍药苷、芍药内酯苷、汉黄芩苷、黄芩苷、甘草苷、柴胡皂苷a、柴胡皂苷b2分别在0.005~0.078、0.010~0.163、0.038~0.603、0.014~0.226、0.004~0.052、0.011~0.170、0.049~0.780、0.003~0.046、0.006~0.092、0.002~0.036 mg·mL-1呈良好线性关系;在测定的3批样品中上述化合物的平均质量分数分别为1.41、2.85、11.06、3.47、1.35、2.88、13.60、0.73、3.13、1.18 mg·g-1。结论:该方法简便,易操作,重复性好,可用于小儿柴葛口服液原方中10种主要成分的含量测定。
中文关键词:小儿柴葛口服液  高效液相色谱法  含量测定  质量控制
 
Content Assay of 10 Components in Original Prescription of Xiaoer Chaige Oral Solution by HPLC
Abstract:Objective:To establish a content assay method for 3′-hydroxypuerarin,3′-methoxypuerarin,puerarin,paeoniflorin,albiflorin,wogonoside,baicalin,liquiritin,saikosaponin a and saikosaponin b2 in the original prescription of Xiaoer Chaige Oral Solution. Methods:HPLC analysis was performed on an Agilent TC-C18 column (250 mm×4.6 mm,5 μm) with gradient elution using acetonitrile as mobile phase A and 0.1% aqueous phosphoric acid as mobile phase B at the flow rate of 1.0 mL·min-1 and column temperature of 30 ℃ under detection wavelength of 230 nm and 210 nm. Results:The method was specific,and its RSDs for precision,repeatability and stability were all less than 2%. 3′-hydroxypuerarin,3′-methoxypuerarin,puerarin,paeoniflorin,albiflorin,wogonoside,baicalin,liquiritin,saikosaponin a and saikosaponin b2 showed good linear relationship in the range of 0.005-0.078,0.010-0.163,0.038-0.603,0.014-0.226,0.004-0.052,0.011-0.170,0.049-0.780,0.003-0.046,0.006-0.092 and 0.002-0.036 mg·mL-1. The average contents of the above compounds in three batches of samples determined were 1.41,2.85,11.06,3.47,1.35,2.88,13.60,0.73,3.13 and 1.18 mg·g-1,respectively. Conclusion:This method is simple,easy to operate and well repeatable,thereby it can be used for the content determination of ten major components in the original prescription of Xiaoer Chaige Oral Solution.
keywords:Xiaoer Chaige Oral Solution  HPLC  content determination  quality control
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