注射用复方维生素(4)的制备及质量考察  

Preparation and quality control of vitamin compound for injection

作　　者：赵鹏[1] 王东凯[1] 邱志斌[1] 张勖[1] 陈婷[1] 邓硕[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4期306-309,共4页Chinese Journal of New Drugs

摘　　要：目的:制备注射用复方维生素(4)并考察其稳定性。方法:以含量、酸度为指标,筛选处方及制备工艺;并考察了3批样品的稳定性。结果:制剂最后处方为维生素A棕榈酸酯、维生素D2,维生素E,维生素K1加适宜的辅料制成,以该处方制备的3批样品在市售包装条件下经加速、室温留样试验考察,质量稳定。结论:处方设计合理,工艺可行。Objective： To study preparation and stability of vitamin compound for injection. Methods：The formula and preparation of vitamin compound for injection were optimized based on the contents and pH environment. Stabilities of 3 batches of the vitamin compound were investigated. Results：The optimal formula was consisted of Vitamin A palmitate, Vitamin D2,Vitamin E,Vitamin K1 and appropriate excipients. The 3 batches of the samples in the commercial package were stable in the accelerated, room temperature storage tests. Conclusion：The optimal formula of vitamin compound for injection was achievable.

关 键 词：复方维生素 注射剂 制备 稳定性 

分 类 号：R927.2[医药卫生—药学] R943.5