国产卵磷脂辅料对脂肪乳制剂质量的影响研究  

Study of Influence of Domestic Lecithin on Quality of Fat Emulsion Preparation

作　　者：王汝涛[1] 陈涛[1] 王惟娇 田江平 

机构地区：[1]西北工业大学生命科学院,陕西西安710072 [2]陕西省脂质体工程技术研究中心,陕西西安710075

出　　处：《中国药业》2007年第23期5-6,共2页China Pharmaceuticals

摘　　要：目的对比研究国产与进口卵磷脂辅料对脂肪乳制剂的质量影响。方法采用药典及国家标准收录的方法对以国产与进口卵磷脂制备的脂肪乳制剂的理化性质、稳定性及细菌内毒素水平进行评价。结果采用国产卵磷脂制备的脂肪乳制剂在pH值、粒径大小、甘油三酯、溶血磷脂、过氧化物及甲氧基苯胺等各项指标上与进口卵磷脂制备的脂肪乳制剂无差异,同时两制剂的稳定性及细菌内毒素水平均符合药典规定标准。结论利用国产及进口卵磷脂制备的脂肪乳制剂质量无差异,都可以达到临床应用的质量要求。Objective To evaluate the influence of domestic and imported lecithin on the quality of fat emulsion injections preparation. Methods The physical and chemical properties of fat emulsion injections were investigated according to the quality standards such as Chinese Pharmacopoeia, and National Standard of Ministry of Health. Results There was no significant difference between the fat emulsion injections preparations by domestic and imported lecithin in pH, particle size, triglyceride, lysophosphatide, peroxide and anisidine respectively, The stability and endotoxin of two fat emulsion injections were complied with Chinese Pharmacopoeia. Conclusion The fat emulsion injections preparation by domestic lecithin has the same physical and chemical properties and stability as the imported.

关 键 词：卵磷脂 脂肪乳注射液 药学特性 评价 

分 类 号：TQ460.4[化学工程—制药化工]