复方地塞米松鼻用凝胶的制备与质量控制  

Preparation and quality control of compound dexamethasone nasal gel

作　　者：洪清[1] 袁曦[1] 林功舟[1] 陈庆伟 

机构地区：[1]福建医科大学附属第一医院,福建福州350005 [2]福州市药品检验所,福建福州350001

出　　处：《中国医院药学杂志》2005年第7期638-639,共2页Chinese Journal of Hospital Pharmacy

摘　　要：目的:制备复方地塞米松鼻用凝胶,并建立质量控制方法。方法:以卡波姆934作为凝胶基质,运用高效液相色谱同时测定盐酸麻黄碱、呋喃西林、地塞米松磷酸钠的含量,并进行稳定性考察。结果:该制剂为淡黄色澄明黏稠凝胶,盐酸麻黄碱、呋喃西林、地塞米松磷酸钠平均回收率分别为99.69%,98.57%,99.00%,RSD分别为1.19%,2.68%,2.30%。加速实验稳定。结论:该制剂制备工艺简便,稳定性良好,质量控制方法快速、准确。OBJECTIVE To prepare compound dexamethasone sodium phosphate nasal gel and establish its quality control method. METHODS The Carbopol 934 was taken as the base of gel. The contents of ephedrine hydrochloride, furacilin and dexarnethasone sodium phosphate were determined by HPLC. The stability was studied, too. RESULTS The nasal gel was yellow, clear and thick. The average recoveries of ephedrine hydrochloride, furacilin and dexarnethasone sodium phosphate were 99. 69 %, 98. 57 % and 99. 00%. The RSD were 1.19% ,2.68% and 2.30%. The result of accelerating test was stable. CONCLUSION The formulation of the nasal gel is with simple the preparation stable, the method of quality control is rapid and accurate.

关 键 词：鼻用凝胶 盐酸麻黄碱 呋喃西林 地塞米松磷酸钠 高效液相色谱 

分 类 号：R925[医药卫生—药学]