摘要
建立气相色谱法测定中、长链脂肪乳注射液中大豆油和中链甘油三酸酯含量的不确定度评定方法。建立数学模型,分析气相色谱法测定中、长链脂肪乳注射液中大豆油和中链甘油三酸酯含量的不确定度来源及影响因素,对各不确定度分量进行评价,计算合成标准不确定度及扩展不确定度。当大豆油质量分数为9.63%时,其扩展不确定度为0.10%(k=2)。当中链甘油三酸酯质量分数为10.00%时,其扩展不确定度为0.11%(k=2)。气相色谱法测定中、长链脂肪乳注射液中大豆油和中链甘油三酸酯含量的不确定度主要来源于对照品和样品溶液制备过程。该不确定度评定为实验过程的控制和测定结果的评估提供了参考,有利于保证该类药品的质量控制水平和检验结果的准确性。
The uncertainty evaluation method of determination of long chain triglycerides and medium chain triglycerides in medium and long chain fat emulsion injection by gas chromatography was established.A mathematical model was established to analyse the sources of uncertainty and influencing factors in the detection process.Each uncertainty component was evaluated and the synthetic standard uncertainty and expanded uncertainty were calculated.When the mass fraction of long chain triglycerides was 9.63%,the expanded uncertainty was 0.10%(k=2).When the mass fraction of medium chain triglycerides was 10.00%,the expanded uncertainty was 0.11%(k=2).The most important factors affecting the measurement results were reference substance and sample solution preparation process.The uncertainty evaluation method provides a referance for the control of the experimental process and the evaluation of the test result,which is good for improving the quality control level of this kind of medicines and keeping the accuracy of the test results.
作者
陈蓉
马冬阳
顾晓风
CHEN Rong;MA Dongyang;GU Xiaofeng(Suzhou Institute for Drug Control,Suzhou 215104,China)
出处
《化学分析计量》
CAS
2023年第10期103-107,共5页
Chemical Analysis And Meterage
关键词
中、长链脂肪乳注射液
气相色谱法
不确定度
大豆油
中链甘油三酸酯
medium and long chain fat emulsion injection
gas chromatography
uncertainty
long chain triglycerides
medium chain triglycerides
