注射用五水头孢唑林钠与替硝唑体外配伍稳定性研究  

Stability of Cefazolin Sodium Pentahydrate Mixed with Tinidazole in Vitro

作　　者：郝好华[1] 宋金春[1] 杨小青[1] 谢顺岚 

机构地区：[1]武汉大学人民医院,湖北武汉430060 [2]武汉大学药学院,湖北武汉430072

出　　处：《中国药物警戒》2015年第6期368-372,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的考察在4℃和25℃条件下五水头孢唑啉钠在替硝唑氯化钠注射液和替硝唑葡萄糖注射液中的兼容性和稳定性;方法初始液为五水头孢唑啉钠分别溶于替硝唑葡萄糖注射液和替硝唑氯化钠注射液,浓度均为临床常用浓度(五水头孢唑啉钠10 mg·m L-1,替硝唑4 mg·m L-1),分别保存在4℃和25℃条件下,配制后0、2、4、8、24、48、72、120、168、240和360 h,从每个容器中取出样品,检查每个样品内部是否有沉淀、云状物、变色,并在0、8、24、48、72、96、120、168、240、360 h用p H计测定样品p H值。使用新建立的高效液相色谱法检测药物浓度。结果经过15天储存,五水头孢唑啉钠与替硝唑糖溶液和替硝唑盐溶液在4℃避光条件下均无浑浊、无沉淀、无云状物、无气泡、不变色,p H值保持稳定;在25℃条件下,五水头孢唑啉钠与替硝唑盐溶液在48 h后开始变黄,72 h后颜色加深,糖溶液和盐溶液p H值均显著上升。结论五水头孢唑啉钠与替硝唑氯化钠注射液和替硝唑葡萄糖注射液配伍溶液在4℃避光条件下至少可以保存15天以上,而在25℃避光条件下应现配现用。Objective To investigate the compatibility and stability of cefazolin sodium pentahydrate in sodium chloride injection and tinidazole glucose injection at 4 ℃ and 25 ℃. Methods The initial solutions are cefazolin sodium pentahydrate dissolving in tinidazole glucose injection and sodium chloride injection and stored at 4 ℃ and 25℃. The initial drug concentrations are 10 mg·mL-1 for cefazolin sodium pentahydrate and 4 mg·mL-1 for tinidazole. Samples were withdrawn from each container immediately after preparation and at predetermined intervals （0, 2, 4, 8, 24, 48, 72, 120, 168, 240 and 360 hours after preparation）. The solutions were visually inspected for precipitation, cloudiness, and discoloration at each samphng interval. New high performance liquid chromatography （HPLC） method was used to detect the drug concentration. Results After 15 days of storage, the samples stored at 4 ℃ were tested retained 〉90 % of the initial concentrations of both drugs. The drug mixtures were clear in appearance, and no precipitation, not muddy, no clouds, no bubbles ,no discoloration. Throughout this period, pH values remained stable, but salt solution samples stored at 25 ℃ were tested low, 48 h later, it started to turn yellow, and after 72 h, the color deepened. The pH values of sugar and salt solution all increased significantly. Conclusion Admixtures of cefazolin sodium pentahydrate 10 mg·mL-1 and tinidazole 4 mg·mL-1 were stable for at least 15 days or more at 4 ℃and under the condition of dark.

关 键 词：五水头孢唑啉钠 替硝唑 配伍 稳定性 

分 类 号：R978[医药卫生—药品] R969.3[医药卫生—药学]