| 方欣欣,严翠霞,梅妮,吕晶,邵泓,郑璐侠.凝胶渗透色谱法同时测定山嵛酸甘油酯中单、二、三甘油酯和游离甘油含量[J].中国药品标准,2023,24(1): |
| 凝胶渗透色谱法同时测定山嵛酸甘油酯中单、二、三甘油酯和游离甘油含量 |
| Determination of monoglycerides, diglycerides, triglycerides and free glycerol in glyceryl dibehenate by Gel Permeation Chromatography |
| 投稿时间：2022-06-07 修订日期：2023-02-08 |
| DOI： |
| 中文关键词: 凝胶渗透色谱法，山嵛酸甘油酯，甘油酯，游离甘油，含量，质量控制 |
| 英文关键词: gel permeation chromatography, glyceryl dibehenate, glyceride, free glycerol, content,quality control |
| 基金项目:国家药典委员会药品标准制修订研究课题：2019Y022 |
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| 中文摘要: |
| 目的：建立凝胶渗透色谱法同时测定山嵛酸甘油酯中单、二、三甘油酯和游离甘油含量。方法：采用两根苯乙烯-二乙烯基苯柱（5μm，100?，300mm×7.8mm）串联；以四氢呋喃为流动相；示差折光检测器；进样器温度、柱温和检测器温度均为35℃。结果：3家企业9批山嵛酸甘油酯中的单、三甘油酯的含量会有差异，二甘油酯的含量基本一致，游离甘油含量均小于1.0%。方法简单快速，且重复性、线性、灵敏度较好。结论：该方法可用于山嵛酸甘油酯的质量控制，同时对企业选用不同含量组分组成的山嵛酸甘油酯有一定的指导意义。 |
| 英文摘要: |
| Objective: To establish a method for the determination of monoglycerides, diglycerides, triglycerides and free glycerol in glyceryl dibehenate by Gel Permeation Chromatography. Methods: Using two columns packed with styrene-divinylbenzene copolymer (7.8mm × 30cm, 5μm) and tetrahydrofuran as mobile phase. Using differential refractive index detector. The temperature of the sample injector, column and detector is 35℃. Results: The content of monotriglyceride and triglyceride in 9 batches of behenate glyceride from 3 enterprises will be different, the content of diglyceride is basically the same, and the content of free glycerol is less than 1.0%. It had good repeatability, linearity and sensitivity. Conclusion: It could be used for quality control of glyceryl behenate. Meanwhile, it provided supported data for enterprises to choose different contents of glyceryl behenate. |
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