云南化工2026，Vol.53Issue(6)：64-67,4.DOI:10.3969/j.issn.1004-275X.2026.06.14
气相色谱法测定长链脂肪乳注射液的脂肪酸组成
Determination of Fatty Acid Compositions in Long Chain Fat Emulsion Injection by Gas Chromatography
鲁丹 1刘淑欣 1江志明 1余浩权 1黄灿中1
作者信息
- 1. 广东嘉博制药有限公司,广东 清远 511517
- 折叠
摘要
Abstract
A gas chromatography analysis system for fatty acid compositions of long chain fat emulsion injection was established to provide a refer-ence for evaluating the quality consistency between the test formulation and the reference formulation.A DB-WAX(30 m×ϕ0.32 mm,0.25 μm)strong polarity gas chromatographic column was employed with an injection volume of 1 μL and a split ratio of 50∶1.The initial column temperature was 230℃(holding for 11min),ramped up to 250℃at a rate of 5℃/min,and maintained for 10 min,with the inlet temperature of 260℃,and the detector temperature of 270℃.In this experiment,a method was established successfully to determine 11 fatty acids compositions of long chain fat emulsion injection.The validated results indicated that the method exhibited well-suited specificity,linear and range,precision,solution stabili-ty and robustness,and the RSD fulfilled the requirements.The fatty acid compositions of six batches for the analysis were checked successfully.关键词
长链脂肪乳注射液/脂肪酸组成/气相色谱法/一致性评价Key words
Long Chain Fat Emulsion Injection/Fatty Acid Composition/Gas Chromatography/Quality Consistency分类
医药卫生引用本文复制引用
鲁丹,刘淑欣,江志明,余浩权,黄灿中..气相色谱法测定长链脂肪乳注射液的脂肪酸组成[J].云南化工,2026,53(6):64-67,4.
