硫酸庆大霉素凝胶剂制备及质量控制  

Preparation and quality control of gentamycin sulfate gel

作　　者：苏石旺[1] 卢戎[1] 

机构地区：[1]广东省江门市皮肤医院,广东江门529000

出　　处：《中国当代医药》2012年第12期129-130,共2页China Modern Medicine

摘　　要：目的制备硫酸庆大霉素凝胶剂并建立其质量控制方法。方法以硫酸庆大霉素为主药,卡波姆为基质制备凝胶剂,采用紫外分光光度法测定硫酸庆大霉素含量并进行稳定性试验。结果制得的凝胶均匀细腻,含量测定方法重复性良好,线性范围为0.02～0.12mg/mL(r=0.9993),回收率为100.23%(RSD=0.52%,n=5)。结论硫酸庆大霉素凝胶剂制备工艺简便可行,制得凝胶符合要求,质量控制方法可靠。Objective To prepare gentamicin sulfate gel and establish its quality control method.Methods Gentamicin sulfate was given as main drug,Carbomer as a base to prepare gel,by ultraviolet spectrophotometric method for the determination of gentamicin sulfate content and stability test.Results The prepared gel evenly delicate,content determination method repeatability was good,the linear range of 0.02-0.12 mg/mL（r = 0.999 3）,the rate of recovery was 100.23%（RSD = 0.52%,n = 5）.Conclusion Gentamycin sulfate gel preparation process is simple and feasible,prepared gel complies with the requirements,quality control method is reliable.

关 键 词：硫酸庆大霉素 凝胶剂 制备 质量控制 

分 类 号：R94[医药卫生—药剂学]