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定量指纹图谱在醒脑通络注射液氨基酸成分分析中的应用
引用本文:胡军华,林夏,仲艳,李慧,吴健雄,李家春,王振中,萧伟.定量指纹图谱在醒脑通络注射液氨基酸成分分析中的应用[J].中国中药杂志,2014,39(10):1811-1815.
作者姓名:胡军华  林夏  仲艳  李慧  吴健雄  李家春  王振中  萧伟
作者单位:江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001;江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001;江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001;江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001;江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001;江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001;江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001;江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001
基金项目:国家“重大新药创制”科技重大专项(2011ZX09401-014)
摘    要:目的:采用定量指纹图谱对醒脑通络注射液成品中的氨基酸成分进行控制,以此来评价其产品的质量。 方法:采用AccQ Tag柱前衍生的方法,建立醒脑通络注射液中氨基酸成分的定量指纹图谱方法,对10批醒脑通络注射液中的各氨基酸进行定量检测,并结合10批成品的相似度指标,综合评价其质量。 结果:醒脑通络注射液中含有12种氨基酸,各氨基酸特征峰定量结果均一、稳定,10批成品指纹图谱相似度在0.90以上。 结论:该方法准确、可行,是一种简便、有效的中药质量评价手段。

关 键 词:醒脑通络注射液  定量指纹图谱  AccQ  Tag柱前衍生  氨基酸
收稿时间:2013/10/9 0:00:00

Application of quantitative fingerprint to amino acids composition analysis of Xingnao Tongluo injection
HU Jun-hu,LIN Xi,ZHONG Yan,LI Hui,WU Jian-xiong,LI Jia-chun,WANG Zhen-zhong and XIAO Wei.Application of quantitative fingerprint to amino acids composition analysis of Xingnao Tongluo injection[J].China Journal of Chinese Materia Medica,2014,39(10):1811-1815.
Authors:HU Jun-hu  LIN Xi  ZHONG Yan  LI Hui  WU Jian-xiong  LI Jia-chun  WANG Zhen-zhong and XIAO Wei
Institution:Jiangsu Kanion Parmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China;Jiangsu Kanion Parmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China;Jiangsu Kanion Parmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China;Jiangsu Kanion Parmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China;Jiangsu Kanion Parmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China;Jiangsu Kanion Parmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China;Jiangsu Kanion Parmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China;Jiangsu Kanion Parmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China
Abstract:Objective: To control the quality of the product, quantitative fingerprint was used to evaluate the composition of the amino acids in the Xingnao Tongluo injection. Method:The method of the quantitative fingerprint to the amino acids composition was established through AccQ Tag precolumn derivatization. The quality was evaluated by the quantitative test of the amino acids and the similarity in ten batches. Result: The Xingnao Tongluo injection contained 12 amino acids and the contents of these amino acids were stable. All the ten batches of the samples had similarity of more than 0.90. Conclusion: The method was accurate, feasible and could be a simple and effective way to evaluate the quality of the traditional Chinese medicine.
Keywords:Xingnao Tongluo injection  quantitative fingerprint  AccQ Tag precolumn derivatization  amino acid
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