柔红霉素毫微粒冻干针剂的研究  

Study on Lyophilization Injection of Daunorubicin Polybutylcyanoacrylate Nanoparticles

作　　者：彭应旭[1,2] 庄燕黎[1,2] 廖工铁[1,2] 

机构地区：[1]上海医药工业研究院 [2]华西医科大学药学院

出　　处：《中国药房》1999年第2期59-60,共2页China Pharmacy

摘　　要：目的：制备易再分散、稳定的柔红霉素聚氰基丙烯酸正丁酯毫微粒（ＤＮＲ－ＰＢＣＡ－ＮＰ）冻干针剂。方法：选用适宜支架剂制得ＤＮＲ－ＰＢＣＡ－ＮＰ冻干针剂，并评价其相关理化性质。结果：冻干前后毫微粒形态、粒径、ｐＨ、包封率及载药量均无明显变化，含水量合格，再分散性良好，制剂稳定。其临界相对湿度为７５．３３％。结论：在适宜的处方及工艺条件下制备ＤＮＲ－ＰＢＣＡ－ＮＰ冻干针剂是可行的。OBJECTIVE : To prepare redispersable and stablcdaunorubicin polybutylcyanoacrylate nanoparticles (DNR-PB-CA-NP) Lyophilizationinjection. METHODS : An optimal supporting agent was choosen to prepare DNR-PBCA-NP lyophiliza-tion injection . The physical and chemical properties of DNR-PBCH-NP lyophilization injection were evaluated . RESULTS : Theshape, diameters, association ratio, drug loading and PH of DNR-PBCA-NP colloidal solution and lyophilization injection havenot been changed. The content of water accorded with the demands of lyophilization injection. The criticalrelative humidity was75. 33% . The stability was good . CONCLUSION : It was practicable to prepare DNR-PBCA-NP lyophilization injection with theoptimal formulation and preparation process.

关 键 词：柔红霉素 毫微粒 冻干针剂 质量评价 DNR-PBCA- 

分 类 号：R978.15[医药卫生—药品] R944.11[医药卫生—药学]