| 电位滴定法测定注射用益气复脉(冻干)中总有机酸 |
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| 引用本文： | 刘一菲,苏小琴,李晶晶,李德坤,鞠爱春,叶正良.电位滴定法测定注射用益气复脉(冻干)中总有机酸[J].现代药物与临床,2018,41(3):493-495. |
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| 作者姓名： | 刘一菲 苏小琴 李晶晶 李德坤 鞠爱春 叶正良 |
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| 作者单位： | 天津中医药大学, 天津 300193,天津天士力之骄药业有限公司, 天津 300402;天津市中药注射剂安全性评价企业重点实验室, 天津 300402,天津中医药大学, 天津 300193,天津天士力之骄药业有限公司, 天津 300402;天津市中药注射剂安全性评价企业重点实验室, 天津 300402,天津天士力之骄药业有限公司, 天津 300402;天津市中药注射剂安全性评价企业重点实验室, 天津 300402,天津天士力之骄药业有限公司, 天津 300402;天津市中药注射剂安全性评价企业重点实验室, 天津 300402 |
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| 摘 要： | 目的 建立用于测定注射用益气复脉（冻干）（YQFM）中总有机酸含量的电位滴定方法。方法 注射用益气复脉（冻干）用水溶解后，经001*1阳离子交换树脂将盐还原为酸，以琥珀酸为对照品，用电位滴定法测定益气复脉中总有机酸的含量。结果 以琥珀酸计，YQFM中总有机酸滴定精密度RSD 0.42%，稳定性RSD 0.84%，重复性RSD 1.88%，平均加样回收率（n=9）为100.15%，RSD 1.68%。结论 本实验所建立的电位滴定方法简便易行，可操作性强，适用于YQFM中总有机酸的含量测定。
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| 关 键 词： | 电位滴定 注射用益气复脉(冻干) 有机酸 含量测定 质量控制 |
| 收稿时间： | 2017/10/23 0:00:00 |
Determination of total organic acids in Yiqi Fumai Lyophilized Injection by potentiometric titration |
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| LIU Yifei,SU Xiaoqin,LI Jingjing,LI Dekun,JU Aichun and YE Zhengliang.Determination of total organic acids in Yiqi Fumai Lyophilized Injection by potentiometric titration[J].Drugs & Clinic,2018,41(3):493-495. |
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| Authors: | LIU Yifei SU Xiaoqin LI Jingjing LI Dekun JU Aichun and YE Zhengliang |
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| Institution: | Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China,Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300402, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300402, China,Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China,Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300402, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300402, China,Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300402, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300402, China and Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300402, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300402, China |
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| Abstract: | Objective To establish a potentiometric titration analytical method for the determination of the total organic acids in Yiqi Fumai Lyophilized Injection (YQFM). Methods With butanedioic acid as reference, the total organic acids in purified YQFM were detected by potentiometric titration. Result The precision, stability, and repeatability of the method were very good with RSD 0.42%, 0.84%, and 1.88%, respectively. The average recovery (n=9) of the method was 100.15% with RSD 1.68%. Conclusion The method is feasible and reproducible, which is suitable for the determination of the total organic acids in YQFM. |
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| Keywords: | potentiometric titration Yiqi Fumai Lyophilized Injection organic acids content determination quality control |
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