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.%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、8～120 μg/ml范围内与峰面积积分值线性关系良好(r均为0.999 9),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、20.045 mg/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.
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