| 引用本文: | 程伟青,严拯宇.脂肪乳注射液中磷脂酰胆碱的稳定性测定[J].中国现代应用药学,2016,33(11):1433-1436. |
| CHENG Weiqing,YAN Zhengyu.Stability Investigation on Lysophosphatidylcholine in the Fat Emulsion Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(11):1433-1436. |
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| 摘要: |
| 目的 采用高效液相色谱-蒸发光散射检测器法（HPLC-ELSD）测定脂肪乳注射液中溶血磷脂酰胆碱的含量变化。方法 以丙二醇键合硅胶柱，正己烷：异丙醇（40：60）为流动相A，异丙醇：水（80：20）为流动相B，梯度洗脱，ELSD检测。结果 温度对本品质量影响较大，宜在25℃条件下贮存。结论 脂肪乳注射液在加速试验和长期试验中溶血磷脂酰胆碱的限量符合相关药品标准。 |
| 关键词: 溶血磷脂酰胆碱 脂肪乳注射液 高效液相色谱法 稳定性 |
| DOI：10.13748/j.cnki.issn1007-7693.2016.11.018 |
| 分类号:O657.7 |
| 基金项目:福建省科技平台建设(2014Y2008) |
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| Stability Investigation on Lysophosphatidylcholine in the Fat Emulsion Injection |
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CHENG Weiqing1, YAN Zhengyu2
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1.Fujian Vocational College of Bioengineering, Fuzhou 350002, China;2.School of Science, China Pharmaceutical University, Key Laboratory of Drug Quality Control and Pharmacovigilanc, Ministry of Education, Nanjing 211198, China
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| Abstract: |
| OBJECTIVE An HPLC-ELSD method was applied to determine the content changes of lysophosphatidylcholine (LPC) in fat emulsion injections. METHODS A propylene glycol bonded silica gel column was used, with the mobile phase A of hexane:isopropyl alcohol (40:60) and B of isopropyl alcohol:water (80:20) by gradient elution and with the application of ELSD. RESULTS The fat emulsion injections were unstable at high temperatures and it should be stored at about 25℃. CONCLUSION The limited contents of LPC in fat emulsion injections could meet the related drug standard both in the accelerated test and long-term test. |
| Key words: lysophosphatidylcholine fat emulsion injections HPLC stability |
