复方阿米卡星洗剂的制备及其稳定性研究  

Study on Preparation and Stability of Compound Amikacin Lotion

作　　者：易军[1] 杨智宁[1] 张丽梅[1] 

机构地区：[1]广东药学院,广州510006

出　　处：《中国药房》2013年第1期65-67,共3页China Pharmacy

摘　　要：目的:制备复方阿米卡星洗剂,并对其稳定性进行初步考察。方法:取阿米卡星与地塞米松磷酸钠2种主药,制备复方阿米卡星洗剂;采用染色-分光光度法测定阿米卡星的含量、紫外-分光光度法测定地塞米松磷酸钠的含量,并通过高温、加速、长期试验对该洗剂进行了稳定性考察。结果:阿米卡星检测质量浓度在0.2～0.7mg/m(lr=0.9993)范围内、地塞米松磷酸钠在5～25μg/ml(r=0.9999)范围内均与其吸光度呈良好线性关系,平均回收率分别为99.84%(RSD=0.81%,n=9)、101.42%(RSD=0.63%,n=9);样品在稳定性考察期内,性状、主药含量均基本保持不变。结论:制剂制备及含量测定方法简便、准确,质量和稳定性均符合要求。OBJECTIVE：To prepare Compound amikacin lotion,and to study its stability.METHODS：Compound amikacin lotion was prepared with amikacin and dexamethasone sodium phosphate as main components.The content of amikacin was determined by dyeing-spectrophotometry and the content of dexamethasone sodium phosphate was determined by UV spectrophotometry.The stability of the lotion was investigated by high temperature test,accelerated test and long-term test.RESULTS：The linear range of amikacin was 0.2-0.7 mg/ml（r=0.999 3）with an average recovery of 99.84%（RSD=0.81%,n=9）.The linear range of dexamethasone sodium phosphate was 5-25 μg/ml（r=0.999 9）with an average recovery of 101.42%（RSD=0.63%,n=9）.The characters and contents of the samples were unchanged in the investigated period of stability.CONCLUSION：Preparation method and content determination method are simple and accurate,and the quality and stability of prepared lotion are in line with the requirement.

关 键 词：复方阿米卡星洗剂 地塞米松磷酸钠 制备 含量测定 稳定性 

分 类 号：R944.1[医药卫生—药剂学]