三种市售中／长链脂肪乳注射液理化指标比较

Comparison of physical and chemical parameters of three market available median/long chain fat emulsions

目的对3种市售中／长链脂肪乳注射液理化指标进行比较。方法根据中国药典、美国药典和国家标准对脂肪乳的质量要求，收集上述市售产品各6个批次进行质量检验和对比。结果产品A：pH为8．2—8．3；无大于5μm乳粒，大于1μm乳粒占1．23％～1．53％；平均粒径为0．246-0．256μm，酸值为0．2，过氧化值为0；甲氧基苯胺值为0．9～1．4；溶血磷脂为0．6—0．9g／L；脂肪、甘油和甘油三酸酯等含量均达到标示量的97％以上；磷含量为0．46—0．49g／L。产品B：pH为8．2；无大于5μm乳粒，大于1μm乳粒占0．81％-1．62％；平均粒径为0．239～0．241μm，酸值为0．4—0．5，过氧化值为0；甲氧基苯胺值为0．8—1．4；溶血磷脂为0．2—0．6g／L；脂肪、甘油和甘油三酸酯等含量均达到标示量的94％以上；磷含量为0．42g／L。产品C：pH为7．7—8．1；无大于5μm乳粒，大于1μm乳粒占0．42％～0．86％；平均粒径为0．249～0．262μm，酸值为0．3—0．4，过氧化值为0；甲氧基苯胺值为1．8～2．9；溶血磷脂为0．5～0．8g／L；脂肪、甘油和甘油三酸酯等含量均达到标示量的96％以上；磷含量为0．44—0．46∥L。结论3种中／长链脂肪乳注射液所有理化指标均符合目前国家药品标准的规定。

Objective To compare the physical and chemical parameters of three market available median/long chain fat emulsions. Methods The quality properties were determined and compared according to the fat emulsion injection quality standards in the Chinese Pharmacopeia Convention, the United States Pharmacopeia Convention, and the National Standard. Results Products A： the pH value was between 8.2-8.3; the particles with a size larger than 1μm were 1.23% -1.53% and no particles were larger than 5 μm; the mean particle size was 0. 246-0. 256 μm ; the acid value was 0. 2 ; the peroxide and methoxyl aniline values were 0 and 0. 9-1.4 ; the hemolysis phosphatide was 0. 6-0. 9 g/L The contents of fat, glycerin, and triglycerides were more than 97% of the labeled amounts ; the content of phosphorus was 0.46-0. 49 g/L Products B ： the pH value was between 8.2 ; the particles with a size larger than 1 μm were 0. 81% -1.62% and no particles were larger than 5 μm; the mean particle size was 0. 239-0. 241μm; the acid value was 0.4-0. 5 ; the peroxide and methoxyl aniline values were 0 and 0. 8-1.4; the hemolysis phosphatide was 0. 2-0. 6 g/L The contents of fat, glycerin, and triglycerides were more than 94% of the labeled amounts; the content of phosphorus was 0. 42 g/L Products C ： the pH value was between 7.7-8. 1 ; the particles with a size larger than 1 μm were 0. 42% -0. 86% and no particles were larger than 5 μm; the mean particle size was 0. 249-0. 262μm; the acid value was 0.3-0. 4 ; the peroxide and methoxyl aniline values were 0 and 1.8-2. 9 ; the hemolysis phosphatide was 0. 5-0. 8 g/L The contents of fat, glycerin, and triglycerides were more than 96% of the labeled amounts; the content of phosphorus was 0. 44-0. 46 g/L Conclusion All properties of the median/long chain fat emulsions produced by the three manufacturers met the National Standard.