中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液的质量评价  

Quality evaluation of Medium long chain fat emulsion,amino acids(16)and glucose(16%)injection

作　　者：陈莲珍 杨谨成 范琳琳 乔涌起 贾贝 王黎明 戚姝娅 吴健雄 袁伟 CHEN Lianzhen;YANG Jincheng;FAN Linlin;QIAO Yongqi;JIA Bei;WANG Liming;QI Shuya;WU Jianxiong;YUAN Wei(Cancer Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,National Clinical Research Center for Cancer,National Cancer Center,Beijing,100021 P.R.China)

机构地区：[1]国家癌症中心国家肿瘤临床医学研究中心中国医学科学院北京协和医学院肿瘤医院,北京100021

出　　处：《华西药学杂志》2022年第1期89-92,共4页West China Journal of Pharmaceutical Sciences

基　　金：国家重点研发计划项目(2016YFA0201500)。

摘　　要：目的比较国产和进口中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液的质量。方法参照国内外同类产品的质量检测标准,测定两厂家生产药品的关键质量指标以及混合后的营养液关键质量指标。用SPSS 24统计软件分析检测结果。结果两厂家产品的各检测指标均符合国家标准规定,其中,国产厂家的过氧化值、甲氧基苯胺值、溶血磷脂酰胆碱、溶血磷脂酰乙醇胺和5-羟甲基糠醛含量等杂质指标均低于进口厂家,差异具有统计学意义。国产药比进口药混合后脂肪乳平均粒径大;但>5μm乳粒的百分比却更低。国产药的渗透压浓度约840 mOsmol·L^(-1),还可于用于外周静脉输注。结论国产和进口的脂肪乳的质量指标均符合国家标准,且国产脂肪乳的质量更优于进口脂肪乳,能保证患者的用药安全。OBJECTIVE To compare the quality of Medium long chain fat emulsion,amino acids(16)and glucose(16%)injection produced by two manufacturers.METHODS Referring to the quality standards of similar products at home and abroad,the crucial quality indicators of the medium long chain fat emulsion,amino acids(16)and glucose(16%)injection and the mixed injection from the two manufacturers were determined.The results were analyzed by SPSS 24 software.RESULTS The quality indexes of the Medium and long chain fat emulsion/amino acid(16)/glucose(16%)injection produced by two manufacturers on the market all conform to the relevant provisions of national standards.The peroxide value,methoxyaniline value,content of lysophosphatidylcholine,1 ysophosphatidyl ethanolamine and 5-hydroxymethyl of the domestic generic manufacturer were significantly lower than these of the imported original manufacturer.The average particle size of the domestic manufacturer was larger than that of the imported manufacturer,but the percentage of particle size>5μm of the domestic manufacturer was lower.CONCLUSION The quality indexes of two manufacturers conform to the national standard,and the quality of fat emulsion of the domestic manufacture is better than that of the imported manufacture,which is efficient to guarantee the safety of clinical medication.

关 键 词：中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 质量评价 粒径 过氧化值 甲氧基苯胺值 溶血磷脂酰胆碱 5-羟甲基糠醛 渗透压 

分 类 号：R917[医药卫生—药物分析学]