卡马西平混悬剂的研制及质量控制研究  

Preparation and quality control study of Carbamazepine(CBZ)Suspension

作　　者：金从形 李阿玲[2] 杜有功[3] 胡大平[3] 陈赛贞[3] 徐珊珊[3] 

机构地区：[1]浙江三门县中医院,三门3171002 [2]温州医学院药学院,2004级学生温州325000 [3]浙江省台州医院,台州317000

出　　处：《海峡药学》2010年第5期82-85,共4页Strait Pharmaceutical Journal

摘　　要：目的研制卡马西平混悬剂,建立质量控制方法 ,以方便小儿及吞咽困难的患者使用。方法用聚乙二醇-400作润湿剂,羧甲基纤维素钠作助悬剂,制备卡马西平混悬剂,并对该制剂的稳定性,再分散性进行考察;用高效液相色谱法测定卡马西平含量,并对方法进行考察。结果加速沉降试验沉降容积比为0.98,重新分散次数4-5次;卡马西平在2-22μg·mL^-1浓度范围线性关系良好,回归方程为Y=31745X＋2359.4,r=0.9999;平均回收率为99.46%。结论本制剂稳定性好,易于分散,含量符合规定,含量测定方法准确可靠。OBJECTIVE Develope the formula and quality control method of CBZ suspension and test the stability,which can be easily used by children and other patients who have difficulties in swallow,and can produce effects quickly.METHODS The suspension was prepared using polyethylene glycol400 as moistening agent and sodium carboxymethyl cellulose as stabilizer.Its stability was studied.Concentrations of CBZ were determined by HPLC,the methods was studied.RESULTS The suspension had excellent stability and it＇s sedimentation volume ratio was 0.98 when accelerate sedimentation and examination of redispersibility is 4-5.The linear ranges of CBZ were 2-22μg·mL^-1,its regression equations was Y=31745X＋2359.4,r=0.9999,and the average recoveries of CBZ for suspension were 99.46%.CONCLUSION This preparation is stable,easy to disperse and its concentration complies with the standard,it＇s credible to assay with HPLC.

关 键 词：卡马西平 混悬剂 制备 含量测定 

分 类 号：R927.2[医药卫生—药学]