丹参酮ⅡA静脉乳剂的制备与质量评价  

Preparation and quality evaluation of intravenous tanshinone Ⅱ_A emulsion

作　　者：梁臻[1] 毛声俊[1] 尹宗宁[1] 金辉[1] 李慧[2] 储婷[1] 

机构地区：[1]四川大学华西药学院,四川成都610041 [2]四川省人民医院,四川成都610072

出　　处：《中国中药杂志》2008年第11期1249-1252,共4页China Journal of Chinese Materia Medica

基　　金：高等学校博士点基金新教师项目(20070610050)

摘　　要：目的:研制丹参酮ⅡA静脉乳剂,并对其进行质量评价。方法:以大豆磷脂与帕洛沙姆188为混合乳化剂,油酸为助乳化剂,甘油为等渗调节剂,高速剪切法制备初乳,再采用高压匀质机对初乳进行匀化,制成丹参酮ⅡA静脉乳剂。结果:自制丹参酮ⅡA静脉乳剂的平均粒径为211 nm,Zeta电位为-32.1 mV,载药量为1 mg.mL-1;25℃条件下避光放置1年,其粒径、Zeta电位、pH、含量及外观性状等指标均未见明显变化。结论:研制的丹参酮ⅡA静脉乳剂理化性质稳定。Objective： To prepare and evaluate an intravenous emulsion of tanshinone Ⅱ A Method： Soybean phospholipid mixing with poloxamer 188 was used as emulsifier. Oleie acid and glycerol were used as co-emulsifier and isoosmotie adjusting agent, respeetively. The coarse emulsion was first prepared and following homogenization was carried out for the coarse emulsion by using a high pressure homogenizer. Result： The average diameter of the prepared tanshlnone Ⅱ A emulsion was 211 nm with a zeta potential of -32. 1 inV. There had no changes of diameter, zeta potential, pH value, content and physleal appearance for the tanshinone Ⅱ A emulsion stored at 25℃ away from light during one year. Conclusion： The physieoehemieal properties of the prepared tanshinone Ⅱ A emulsion was stable, which could meet the requirements of intravenous administration.

关 键 词：丹参酮ⅡA 静脉乳剂 制备工艺 质量评价 

分 类 号：TQ461[化学工程—制药化工]