| 凝胶色谱法测定参芪扶正注射液中的高分子物质 |
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| 引用本文： | 杨立伟,肖树雄,谢海燕,宋艳刚,刘学华.凝胶色谱法测定参芪扶正注射液中的高分子物质[J].中国药房,2011(15):1400-1401. |
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| 作者姓名： | 杨立伟 肖树雄 谢海燕 宋艳刚 刘学华 |
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| 作者单位： | 广东省药品检验所;丽珠集团利民制药厂; |
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| 基金项目： | 粤港关键领域重点突破项目(TC07BF09-11) |
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| 摘 要： | 目的:建立测定参芪扶正注射液中高分子物质的方法。方法:采用凝胶色谱法。色谱柱为TSKGEL2000SWxl(300mm×7.8mm,5μm),流动相为乙腈-0.83%三氟乙酸溶液(40∶60),流速为0.7mL·min-1,检测波长为214nm。结果:参芪扶正注射液中高分子物质在分子量1638～13700范围内,分子量对数与出峰时间呈良好线性关系(r=0.9848)。各批样品含高分子物质的量均≤1.0%。结论:该方法操作简便,结果准确、可靠,可以作为参芪扶正注射液的内控质量标准方法。
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| 关 键 词： | 参芪扶正注射液 高分子物质 凝胶色谱法 |
Determination of High Molecular Substances in Shenqi Fuzheng Injection by Gel Chromatography |
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| YANG Li-wei,XIAO Shu-xiongXIE Hai-yan,SONG Yan-gang,LIU Xue-hua.Determination of High Molecular Substances in Shenqi Fuzheng Injection by Gel Chromatography[J].China Pharmacy,2011(15):1400-1401. |
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| Authors: | YANG Li-wei XIAO Shu-xiongXIE Hai-yan SONG Yan-gang LIU Xue-hua |
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| Institution: | YANG Li-wei,XIAO Shu-xiong(Guangdong Institute for Drug Control,Guangzhou 510180,China)XIE Hai-yan,SONG Yan-gang,LIU Xue-hua(Lizhu Group Limin Pharmaceutical,Shaoguan 512028,China) |
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| Abstract: | OBJECTIVE：To establish a method for the determination of high molecular substances in Shenqi fuzheng injection.METHODS：Gel chromatography was adopted.TSK GEL 2000 SWxl（300 mm×7.8 mm,5 μm） column was used with mobile phase consisted of acetonitrile-0.83% trifluoracetic acid（40：60） at flow rate of 0.7 mL·min-1.The detection wavelength was set at 214 nm.RESULTS：The weight of high molecular substances from 1 638 to 13 700 showed a good linear relationship between the logarithm of molecular weight and retention times（r=0.984 8）.The weight of high molecular substances in different batches was lower than 1.0%.CONCLUSION：The method is simple,accurate and reliable for internal quality control of Shenqi fuzheng injection. |
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| Keywords: | Shenqi fuzheng injection High molecular substances Gel chromatography |
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