复方水杨酸凝胶的研制及质量控制

目的:制备复方水杨酸凝胶,并建立质量控制方法.方法:采用正交试验法筛选最佳基质处方,以三乙醇胺为中和剂,加入水杨酸和苯甲酸制成凝胶剂;建立酸碱度、卫生学、含量测定等质控方法,进行刺激性试验,离心试验,耐热耐寒试验.结果:pH 6.0～7.0,其他各项检查均符合凝胶剂的有关规定,水杨酸和苯甲酸的平均回收率分别为99.4%,98.1%,RSD分别为0.52%(n=6),0.63%(n=6).结论:本制剂制备工艺简单,性质稳定,质量可控,适于医院制剂.

Preparation and quality control of compound salicylic acid gel

OBJECTIVE To prepare compound salicylic acid gel and establish a method for its quality control. METHODS To choose the best basic formula with orthogonal design test. With triethanola mine as neutralizer, salicylic acid and benzoic acid were added to the gel; The quality control methods for acidity and alkalinity,hygienic,content determination etc were established. The tests of impulse, centrifugation, cold-resistant and heat-resistant were prosecuted. RESULTS The pH value was 6.0 - 7.0 , other tests accord with the requirements of gel. The average recover of salicylic acid and benzoic acid were 99.4% ,RSD= 0.52% ( n =6); 98.1% ,RSD= 0.63% ( n =6). CONCLUSION The preparation of the gel is simple. The gel is stable and its quality can be controlled.