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| 清开灵注射液中10种有效成分的同时测定及其质量相关性研究 | |
| 引用本文： | 武彦舒,金城,张倩,焦懿,鄢丹,肖小河,杜晓曦,王建.清开灵注射液中10种有效成分的同时测定及其质量相关性研究[J].光谱学与光谱分析,2009,29(11):3112-3116. |
| 作者姓名： | 武彦舒 金城 张倩 焦懿 鄢丹 肖小河 杜晓曦 王建 |
| 作者单位： | 1. 解放军302医院全军中药研究所,北京,100039;成都中医药大学药学院,四川,成都,611137 2. 解放军302医院全军中药研究所,北京,100039 3. 湖南中医药大学药学院,湖南,长沙,410002 4. 国家食品药品监督管理局药品审评中心,北京,100038 5. 成都中医药大学药学院,四川,成都,611137 |
| 基金项目： | 国家杰出青年科学基金项目，国家中医药管理局研究专项，国家自然科学基金项目 |
| 摘 要： | 采用HPLC-DAD-ELSD法,在最优波长(255 nm)下同时测定了清开灵注射液的10种有效成分,测定了不同厂家的15个批次清开灵注射液样品,进行了质量相关性分析.所建立的分析方法符合规定标准,所测样品中,不同厂家及同厂家不同批次样品间各组分的含量差异悬殊(RSD值范围为2.17%～65.54%).方法简便可靠,可用于清开灵注射液的质量控制.尽量多地控制这些已知的主要有效成分是保证清开灵注射液质量的关键. |
| 关 键 词： | 清开灵注射液 同时测定 10种有效成分 质量控制 |
| 收稿时间： | 2008/8/8 |
Simultaneous Determination of Ten Active Components in Qingkailing Injection and Relationship with Quality Control |
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| WU Yan-shu,JIN Cheng,ZHANG Qian,JIAO Yi,YAN Dan,XIAO Xiao-he,DU Xiao-xi,WANG Jian. PLA Institute of Chinese Materia Medica, Military Hospital of China,Beijing ,China. Pharmacy College,Chengdu University of Traditional Chinese Medicine,Chengdu ,China. Pharmacy College,Hunan University of Traditional Chinese Medicine,Changsha ,China. Centre for Drug Evaluation,State Food , Drug Administration,Beijing ,China.Simultaneous Determination of Ten Active Components in Qingkailing Injection and Relationship with Quality Control[J].Spectroscopy and Spectral Analysis,2009,29(11):3112-3116. | |
| Authors: | WU Yan-shu JIN Cheng ZHANG Qian JIAO Yi YAN Dan XIAO Xiao-he DU Xiao-xi WANG Jian PLA Institute of Chinese Materia Medica Military Hospital of China Beijing China Pharmacy College Chengdu University of Traditional Chinese Medicine Chengdu China Pharmacy College Hunan University of Traditional Chinese Medicine Changsha China Centre for Drug Evaluation State Food Drug Administration Beijing China |
| Institution: | WU Yan-shu1,2,JIN Cheng1,ZHANG Qian1,JIAO Yi3,YAN Dan1,XIAO Xiao-he1,DU Xiao-xi4,WANG Jian21. PLA Institute of Chinese Materia Medica,302 Military Hospital of China,Beijing 100039,China2. Pharmacy College,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China3. Pharmacy College,Hunan University of Traditional Chinese Medicine,Changsha 410002,China4. Centre for Drug Evaluation,State Food and Drug Administration,Beijing 100038,China |
| Abstract: | A method was established for simultaneous determination of ten active components in Qingkailing injection (QKL),and could be used as a feasible method for the quality control of QKL. HPLC-DAD-ELSD was employed for the determination at the optimal wavelength (255 nm). Fifteen samples of QKL at different batches from different factories were analyzed by the means. The results show that the method is corresponding with specified standard. The contents from different samples (QKL from different factories and di... |
| Keywords: | HPLC-DAD-ELSD |
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