增效磺胺嘧啶银混悬剂的制备与质量控制  

Preparation and Quality Control of Synergist Flamazine Suspension

作　　者：高新富[1] 徐彦飞[1] 丁召兴[1] 张循格[1] 边瑞民[1] 

机构地区：[1]滨州医学院附属医院,山东滨州256603

出　　处：《中国药房》2013年第1期60-62,共3页China Pharmacy

摘　　要：目的:制备增效磺胺嘧啶银混悬剂并建立其质量控制方法。方法:以磺胺嘧啶银配伍甲氧苄啶制备增效磺胺嘧啶银混悬剂,采用高效液相色谱法测定磺胺嘧啶银和甲氧苄啶的含量,并考察制剂稳定性。结果:磺胺嘧啶银和甲氧苄啶检测质量浓度分别在20～300、8～120μg/ml范围内与峰面积积分值线性关系良好(r均为0.9999),平均回收率分别为99.76%、100.27%,RSD分别为0.38%、0.41%;3批样品中磺胺嘧啶银和甲氧苄啶的平均含量分别为49.774、20.045mg/ml;制剂在室温、避光条件下6个月内稳定性良好。结论:增效磺胺嘧啶银混悬剂制备工艺合理,质量稳定可控。OBJECTIVE：To prepare Synergist flamazine suspension and to establish the method for its quality control.METHODS：Synergist flamazine suspension was prepared with flamazine and trimethoprim.The contents of flamazine and trimethoprim were determined by HPLC and the stability of the preparation was studied.RESULTS：The linear ranges of flamazine and trimethoprim were 20-300 μg/ml and 8-120 μg/ml（both r=0.999 9）.Average recoveries were 99.76%（RSD=0.38%）and 100.27% （RSD=0.41%）.Average contents of flamazine and trimethoprim in 3 batches of sample were 49.774 mg/ml and 20.045 mg/ml.The stability of suspension was good in dark place at room temperature within 6 months.CONCLUSION：Preparation technology of Synergist flamazine suspension is reasonable and stable in quality.

关 键 词：增效磺胺嘧啶银混悬剂 甲氧苄啶 制备 质量控制 高效液相色谱法 

分 类 号：R944.9[医药卫生—药剂学]