摘要
目的了解不同生产厂家中/长链脂肪乳注射液的质量差异。方法从医药流通市场购买不同生产厂家的中/长链脂肪乳注射液各3个批次,对其pH值、平均粒径、粒径分布、游离脂肪酸、过氧化值、甲氧基苯胺值、溶血磷脂酰胆碱与溶血磷脂酰乙醇胺、甘油、渗透压摩尔浓度、含量等进行测定与对比。结果共分析6个不同生厂家的中/长链脂肪乳注射液,受试批次pH值为7.4~8.3;平均粒径为0.181~0.298μm;>5μm百分比为0.93×10^-3%~34.5×10^-3%;游离脂肪酸均为0.01 mmol/g;过氧化值均未检出;甲氧基苯胺值为0.8~1.7;溶血磷脂酰胆碱为0.5~0.9 mg/mL;溶血磷脂酰乙醇胺为0.1~0.2 mg/mL;甘油为2.46~2.59mg/mL;渗透压摩尔浓度为372~404 mOsmol/kg;大豆油为93.8%~103.4%;中链甘油三酸酯为98.5%~102.1%;α-生育酚为0.000%~0.018%。结论6个不同生产厂家的中/长链脂肪乳注射液3个批次均符合中/长链脂肪乳注射液国家标准公示稿要求。
Objective The aim of this study was to evaluate the quality differences of six commercial medium/long chain fat emulsion injections.Methods Three batches of medium/long chain fat emulsion injections from six manufacturers were purchased from market.Their pH,globule size,globule size distribution,free fatty acid,peroxide value,methoxyaniline value,lysophosphatidylcholine and lysophosphatidylethanolamine,glycerol,osmolality,and contents were measured and compared.Results The tested batches pH were 7.4-8.3,the average particle size were 0.181-0.298μm,particle size>5μm percentage were 0.93×10^-3%-34.5×10^-3%,the free fatty acids were 0.01 mmol/g,the peroxide value were not detected,methoxyaniline value were 0.8-1.7,lysophosphatidylcholine were 0.5-0.9 mg/mL,lysophosphatidylethanolamine were 0.1-0.2 mg/mL,glycerol were 2.46-2.59 mg/mL,osmolality were 372-404 mOsmol/kg,the soybean oil were 93.8%-103.4%,the medium chain triglyceride were 98.5%-102.1%,and theα-tocopherol were 0.000%-0.018%.Conclusion The test three batches of the medium/long chain fat emulsion injections of the six manufacturers all meet the requirements of the national standard for medium/long chain fat emulsion injection.
作者
赵彬
高瑞辰
焦蕾
梅丹
ZHAO Bin;GAO Rui-chen;JIAO Lei;MEI Dan(Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China;Department of Pharmacy,The Central Hospital of Jiamusi City,Heilongjiang Jiamusi 154002,China)
出处
《临床药物治疗杂志》
2020年第4期35-39,共5页
Clinical Medication Journal
关键词
中/长链脂肪乳注射液
质量评价
一致性评价
medium/long chain fat emulsion injection
quality evaluation
correspondence evaluation
