注射用氯诺昔康的制备及稳定性研究  

Study of the Preparation Technology and Stability of Lornoxicam for Injection

作　　者：付桂英[1] 郭华[1] 左秀萍[1] 高晖[1] 温明铃[1] 

机构地区：[1]解放军307医院,北京市100039

出　　处：《中国药房》2005年第9期671-673,共3页China Pharmacy

摘　　要：目的制备注射用氯诺昔康并考察其稳定性。方法以含量、有关物质、pH值为指标,筛选处方及制备工艺;考察3批样品的稳定性。结果最佳处方为氯诺昔康4.0g、丙二醇4.0g、甘露醇100g、氢氧化钠1mol/L适量,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 prepare Lornoxicam for injection and to study its stability.METHODS:The formular and pre paration technology of Lornoxicam for injection was optimized with the index of contents,the related substances and pH value;3batches of samples'stability was investigated.RESULTS:The best formula was found to be the following:4.0g of lornoxicam,4.0g of propylene glycol,100g of mannitol and sufficient quantum of1mol/L caustic soda,3batches of sample preparations man ufactured under this formula were found to be stable in quality in the accelerated,room temperature storage test under the condition of commercial packing.CONCLUSION:The formula design was reasonable and the preparation technology was feasible.

关 键 词：氯诺昔康 注射剂 制备 稳定性 

分 类 号：R971.1[医药卫生—药品] R927.1[医药卫生—药学]