影响盐酸金刚烷胺糖浆性状稳定性的因素及改进方法  

The Factors Affecting the Stability of Amantadine Hydrochloride Syrup and Measures for Improvement

作　　者：杨燕欢 

机构地区：[1]江西金芙蓉药业有限公司,江西彭泽332701

出　　处：《中国执业药师》2011年第10期40-42,共3页China Licensed Pharmacist

摘　　要：目的:研究使盐酸金刚烷胺糖浆出现结晶现象的因素。方法:通过冷藏5℃、恒温15℃、加速实验、室内等条件按《中国药典》2005年版工艺处方生产的盐酸金刚烷糖浆和按改变工艺处方生产的盐酸金刚烷胺糖浆性状进行稳定性观察。结果:用苯甲酸钠、苯甲酸、山梨酸钾配制的盐酸金刚烷胺糖浆在低温条件5℃(冬天)容易出现结晶现象。结论:盐酸金刚烷胺糖浆使用羟苯乙酯作为防腐剂或在15℃以上储存质量比较稳定。Objective：To study the factors inducing crystallization of amantadine hydrochloride syrup. Methods： To conduct the stability observation of amantadine hydrochloride syrup, either produced by the ChP.2005 edition methods or with the changed prescriptions, by the storage conditions at 5℃, at constant temperature of 15℃ , accelerated test, at room temperature and so on. Results： Crystallization can be found in amantadine hydrochloride syrup prepared with sodium benzoate, benzoic acid and potassium sorbate when it was stored at 5℃ （in winter）. Conclusion： The quality of amantadine hydrochloride syrup was stable if ethylparoben was used as a preservative or it was stored at 15℃ or above.

关 键 词：盐酸金刚烷胺糖浆 防腐剂 稳定性 

分 类 号：R927.2[医药卫生—药学]