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气相色谱法快速测定疏血通注射液中乙酸、丙酸、丁酸的含量
李灵云1, 倪开岭2, 李敏1, 韩立峰1, 杨静1, 柴欣1, 王跃飞1
1.天津中医药大学天津市现代中药重点实验室, 天津 301617;2.牡丹江友搏药业有限责任公司, 牡丹江 157011
摘要:
[目的] 建立疏血通注射液中短链脂肪酸(乙酸、丙酸、丁酸)的含量测定方法。[方法] 采用气相色谱法(GC)以2-乙基丁酸为内标物,测定疏血通注射液中乙酸、丙酸、丁酸含量。采用DB-FFAP弹性石英毛细管柱(30 m×0.25 mm×0.25 μm),程序升温,在18 min内实现了成分分析,载气:高纯氮气(N2),流速1.0 mL/min,尾吹气:高纯氮气(N2),流速25 mL/min,进样口温度:240℃,检测器(FID)温度:240℃。[结果] 对疏血通原料药水蛭及地龙进行气相分析发现,水蛭与地龙药材中均含有乙酸、丙酸、丁酸。通过分析36批次的疏血通注射液发现乙酸、丙酸、丁酸含量分别为382.2~544.6 μg/支、90.92~217.5 μg/支、39.74~64.27 μg/支,不同批次的疏血通注射液乙酸、丙酸、丁酸含量差异较大、总含量相对稳定。[结论] 本研究建立的疏血通注射液中乙酸、丙酸、丁酸的含量测定方法简便、快速、灵敏,适用于该产品的质量控制研究。
关键词:  疏血通注射液  乙酸  丙酸  丁酸  气相色谱
DOI:10.11656/j.issn.1672-1519.2020.01.21
分类号:R284.1
基金项目:重大新药创制科技重大专项项目(2015ZX09J15102-004)。
Rapid determination of acetic acid,propionic acid and butyric acid in Shuxuetong Injection by gas chromatography
LI Lingyun1, NI Kailing2, LI Min1, HAN Lifeng1, YANG Jing1, CHAI Xin1, WANG Yuefei1
1.Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;2.Mudanjiang Youbo Pharmaceutical Co., LTD., Mudanjiang 150711, China
Abstract:
[Objective] A rapid method was established for determination of short-chain fatty acids(acetic acid,propionic acid and butyric acid) in Shuxuetong Injection by gas chromatography.[Methods] The contents of acetic acid,propionic acid and butyric acid in Shuxuetong Injection were determined by gas chromatography (GC) with 2-ethylbutyric acid as internal standard. Using DB-FFAP elastic quartz capillary column(30 m×0.25 mm×0.25 μm),the component analysis was realized within 18 min after programmed temperature rise. The high purity nitrogen (N2) was employed as carrier gas(1.0 mL/min) and make-up gas (25 mL/min),respectively. The temperature of inlet and FID detector was fixed at 240℃.[Results] Through the analysis of leeches and earthworm,the raw material of Shuxuetong Injection,it was found that both leeches and earthworm contained acetic acid,butyric acid and propionic acid. Through analysis of 36 batches of Shuxuetong Injection,it was found that the content of acetic acid,propionic acid and butyric acid was 382.2~544.6 μg per ampulla bottle,90.92~217.5 μg per ampulla bottle,39.74~64.27 μg per ampulla bottle,respectively. There is visible different on the contents of acetic acid,propionic acid and butyric acid in different batches of Shuxuetong injection,and the total content of these acids are relatively stable.[Conclusion] The method established in this study for the determination of acetic acid,propionic acid and butyric acid in Shuxuetong Injection is simple,rapid and sensitive.
Key words:  Shuxuetong Injection  acetic acid  propionic acid  butyric acid  gas chromatography
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