中国药物警戒 ›› 2015, Vol. 12 ›› Issue (6): 368-372.

• 医院药事管理与合理用药 • 上一篇    下一篇

注射用五水头孢唑林钠与替硝唑体外配伍稳定性研究

郝好华1,宋金春1*,杨小青1,谢顺岚1   

  1. 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
  • 收稿日期:2015-03-05 出版日期:2015-06-08 发布日期:2015-07-27
  • 通讯作者: 宋金春,男,博士?硕导,主任药师,临床药学。
  • 作者简介:郝好华,女,在读硕士,临床药学。
  • 基金资助:
    技部“重大新药创制”科技重大专项“中药上市后再评价关键技术研究”(2009ZX09502-030),江苏省中医院科技项目课题(Y11023)。

Stability of Cefazolin Sodium Pentahydrate Mixed with Tinidazole in Vitro

HAO Hao-hua1,SONG Jin-chun1*,YANG Xiao-qing1,XIE Shun-lan2   

  1. 1Renmin Hospital of Wuhan University, Hubei Wuhan 430060, China;
    2School of Pharmacy, Wuhan University, Hubei Wuhan 430072, China
  • Received:2015-03-05 Online:2015-06-08 Published:2015-07-27

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?mL-1,替硝唑4 mg?mL-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pH计测定样品pH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,pH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pH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。

关键词: 五水头孢唑啉钠, 替硝唑, 配伍, 稳定性

Abstract: 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 Samples were withdrawn from each container immediately after preparation and at predetermined intervals (0, 2, 4, 8, 24, 48, 72, 120, 168, 240 and 360 hours after preparation).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 sampling 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.

Key words: cefazolin sodium pentahydrate, tinidazole, compatibility, stability

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