盐酸羟甲唑啉眼用即型凝胶的制备及其质量控制  

Preparation and Quality Control of Oxymetazoline Hydrochloride in Situ Forming Eye Gel

作　　者：黄鹏[1] 苏泉[1] 吴明钗[1] 董邦铃[2] 

机构地区：[1]温州医学院附属第三医院,浙江瑞安325200 [2]温州医学院,浙江温州325035

出　　处：《中国药房》2012年第33期3120-3121,共2页China Pharmacy

摘　　要：目的:制备盐酸羟甲唑啉眼用即型凝胶,并对其质量进行控制。方法:以泊洛沙姆407为基质制备凝胶,采用高效液相色谱法测定盐酸羟甲唑啉的含量。结果:该制剂pH及其他检查均符合眼用凝胶的相关规定,盐酸羟甲唑啉在50～500mg·L-1(r=0.9999)浓度范围内线性关系良好,平均回收率为100.48%,RSD=1.4%。结论:本制剂处方合理,制备工艺简便,质量可控,是一种较为理想的眼用制剂。OBJECTIVE：To prepare Oxymetazoline hydrochloride in situ forming eye gel and to control the quality of it.METHODS：The gel was prepared with poloxamer 407 as base,and the content of oxymetazoline hydrochloride was determined by HPLC.RESULTS：The linear range of oxymetazoline hydrochloride was 50～500 mg·L-1（r=0.999 9） with recovery rate of 100.48%（RSD=1.4%）.CONCLUSION：The preparation method is reasonable,simple and controllable,and it is an ideal ophthalmic preparation.

关 键 词：盐酸羟甲唑啉 眼用即型凝胶 高效液相色谱法 制备 质量控制 

分 类 号：R944.7[医药卫生—药剂学] R988.1[医药卫生—药学]