注射用赖氨洛芬的研制及其质量控制  

Preparation and Quality Controll of Ibuprofen Lysine Sterilized powder for Injection

作　　者：何文[1] 罗云[1] 张洪[1] 蔡鸿生 

机构地区：[1]湖北医科大学附属第一医院药学部,武汉430060

出　　处：《中国药师》2000年第4期213-214,共2页China Pharmacist

摘　　要：目的:研制注射用赖氨洛芬,为临床提供一种高效、低毒、速效的布洛芬新制剂奠定基础。方法:合成并精制赖氨洛芬原料,用HPLC法检测其纯度后,制成无菌粉末,对其性状、澄明度、含量、稳定性、肌注刺激性等进行了检测。结果:本制剂质量稳定,肌注刺激性小。结论:本制剂适合肌注给药,可做进一步临床考察。Objective: To study the preparing technology of ibuprofen lysine sterilized powder for injection in order to provide a new type of ibuprofen with higher effect, less irritation, and rapid action for clinic. Methods: The materials of ibuprofen lysine, of which concentration was deternined by HPLC, were synthesized and purified. The quality of the preparation such as char- acteristics, clearance degree, stability, irritation to muscles, were also determined. Results: The quality of preparation was stable with less irritation. Conclusion: The preparation an be used as injection and is valuable to further study on clinic effect.

关 键 词：赖氨洛芬 质量控制 注射剂 

分 类 号：R971.1[医药卫生—药品] R927.11[医药卫生—药学]