顺铂静脉注射乳剂的制备及其性质考察  

Preparation and characteriztion of cisplatin emulsions for injection

作　　者：杨秀丽[1] 王东凯[1] 孔俐文[1] 王丽君[1] 宋扬[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2007年第17期1376-1379,共4页Chinese Journal of New Drugs

摘　　要：目的:制备顺铂静脉注射乳剂并对其性质进行考察。方法:通过正交设计优选了顺铂乳剂的最佳处方及其制备工艺,并通过粒径、ζ电位、pH值的测定和稳定性的考察初步研究了顺铂乳剂的一些基本性质。结果:顺铂乳剂的最佳处方为磷脂0.9%,泊洛沙姆-1882%和油酸0.2%,制备温度为70℃。所制备的乳剂平均粒径为144nm,ζ电位为-29.8mV。稳定性实验表明乳剂在高温灭菌、长期稳定性试验中粒径、pH值和含量无明显的变化。结论:本实验制备的顺铂乳剂粒径分布较窄,稳定性较好。Objective： To characterize the newly developed cisplatin emulsions for injection. Methods：The formulation and procedure of cisplatin emulsions were optimized by orthogonal experiments. The cisplatin intravenous emulsion was studied based on stability and the determination of the particle size, ζ potential and pH values. Results：The optimal formulation consisted of soybean phospholipids 0.9% , poloxamer-188 2% , oleic acid 0.2%. The preparation temperature was set at 70℃. The ζ potential and the mean particle size values of the emulsions were - 29.8 mV and 144 nm, respectively. The stability study showed that the mean particle size, pH values and quality had no obvious changes during high temperature sterilization and long term test. Conclusion-The cisplatin emulsions for intravenous injection was stable.

关 键 词：顺铂 乳剂 粒径 稳定性 

分 类 号：R943.41[医药卫生—药剂学] R979.1[医药卫生—药学]