马来酸氯苯那敏口服液处方工艺的筛选及质量的研究  

Prescription and quality control of chlorpheniramine maleate oral liquid

作　　者：李根 伍丽萍 

机构地区：[1]成都市妇女儿童中心医院,成都610091

出　　处：《中南药学》2016年第8期827-830,共4页Central South Pharmacy

摘　　要：目的筛选马来酸氯苯那敏口服液的处方工艺,并对其质量进行研究。方法根据小儿临床用药的特殊性,计算出适宜分剂量服用的溶液浓度,并对口服液的p H值、灭菌条件、矫味剂种类和用量进行考察,确定最佳处方工艺;按照处方工艺制样,采用高效液相色谱法测定样品中马来酸氯苯那敏的含量。结果该处方工艺制得的样品在进行影响因素、加速和长期稳定性试验后,含量基本稳定。该色谱条件下马来酸和氯苯那敏具有很好的分离效果;线性关系良好(r=0.9996),平均回收率>98%,重复性试验RSD值为0.45%,精密度试验RSD值为0.82%。结论该处方工艺可以用于生产马来酸氯苯那敏口服溶液,建立的色谱方法操作简便、准确、重复性好,可用于马来酸氯苯那敏口服溶液质量的控制。Objective To screen the prescription process of the oral liquid of chlorpheniramine maleate and control its quality. Methods According to the characteristics of clinical medication of pediatrics, we calculated suitable concentration which was easily divided into doses. We examined the p H, sterilization conditions, the type and dosage of the agent, and determined the best prescription. High performance liquid chromatography was used to determine the content of chlorphenamine maleate in the oral liquid. Results The content of the samples was basically stable after the test of influencing factors, accelerating and permanent stability. Maleate and chlorphenamine were well separated. The average recovery rate were higher than 98% and the RSD of repeatability and precision test value was 0.45% and 0.82%. Conclusion The prescription can be used to produce the oral solution of chlorpheniramine maleate. The method is simple, accurate and reproducible, and can be used for the quality control of the oral solution.

关 键 词：儿科用药 马来酸氯苯那敏 处方工艺 稳定性 质量控制 

分 类 号：R927[医药卫生—药学]