复方更昔洛韦氢化可的松琥珀酸钠鼻用凝胶剂制备及质量控制  

Preparation and quality control of nasal gel of ganciclovir- hydrocortisone sodium succinate compound

作　　者：朱铁梁[1,2] 戴学文[3] 王姿婧[3] 刘青[3] 房志仲[3] 高文远[1] 

机构地区：[1]天津大学药物科学与技术学院,天律300072 [2]武警后勤学院附属医院药剂科,天津300162 [3]天津医科大学药学院,天津市临床药物关键技术重点实验室,天津300070

出　　处：《武警后勤学院学报（医学版）》2016年第1期32-36,共5页Journal of Logistics University of PAP（Medical Sciences）

摘　　要：【目的】制备复方更昔洛韦氢化可的松琥珀酸钠鼻用凝胶剂,建立制剂的质量控制方法。【方法】以卡波姆为基质制备复方更昔洛韦氢化可的松琥珀酸钠鼻用凝胶剂,采用高效液相色谱法同时测定更昔洛韦和氢化可的松琥珀酸钠的含量。【结果】更昔洛韦在4.04~24.24μg/ml与峰面积线性良好,r=0.9999（n=3）,在80%、100%、120%的回收率试验中,其平均回收率分别为100.34%、100.34%、101.30%,RSD%分别为1.27%、0.27%、0.33%（n=3）。氢化可的松琥珀酸钠在8.64~34.56μg/ml与峰面积线性良好,r=0.9997（n=3）,在80%、100%、120%的回收率试验中,其平均回收率分别为99.40%、100.49%、100.35%,RSD%分别为1.27%、1.56%、0.60%。【结论】复方更昔洛韦氢化可的松琥珀酸钠鼻用凝胶剂制备方法简单,质量控制方法简便、准确、可靠。【Objective】To prepare the nasal gel of ganciclovir- hydrocortisone sodium succinate compound, and establish an appropriate method to control its quality.【Methods】Carbomer was used as the matrix to prepare the nasal gel of ganciclovirhydrocortisone sodium succinate compound. The contents of ganciclovir and hydrocortisone sodium succinate were simultaneously determined with HPLC method.【Results】Ganciclovir showed a fine linear relationship with peak area in the concentration range of4.04-24.24 μg/ml, r=0.9999（n=3）; the results of 80%, 100% and 120% recovery tests showed that the average recovery of ganciclovir was 100.34%, 100.34% and 101.30% respectively, and RSD% was respectively 1.27%, 0.27% and 0.33%（n=3）. Hydrocortisone sodium succinate showed a fine linear relation with peak area in the concentration range of 8.64-34.56 μg/ml, r=0.9997（n=3）, and the results of 80%, 100% and 120% recovery tests showed that the average recovery of hydrocortisone sodium succinate was 99.40%,100.49% and 100.35%, and RSD% was respectively 1.27%, 1.56% and 0.60%.【Conclusions】The method for preparing the nasal gel of ganciclovir- hydrocortisone sodium succinate compound is simple, and its quality control is convenient, accurate and credible.

关 键 词：更昔洛韦 氢化可的松琥珀酸钠 鼻用凝胶剂 质量控制 高效液相色谱法 

分 类 号：R944[医药卫生—药剂学]