替硝唑与盐酸左氧氟沙星复方泡腾片的制备与质量控制  

Preparation and quality control of tinidazole and levofloxacin effervescent tablets

作　　者：张磊[1] 朱铁梁[1] 张莉[2] 李虎[2] 陈莉[2] 

机构地区：[1]武警医学院附属医院药剂科,天津300162 [2]武警医学院药剂学教研室,天津300162

出　　处：《中国医院药学杂志》2009年第2期110-113,共4页Chinese Journal of Hospital Pharmacy

基　　金：武警医学院青年基金资助项目(编号:WYQ2006-13)

摘　　要：目的:建立替硝唑与盐酸左氧氟沙星复方泡腾片口捷爽的制备方法,并对其进行质量控制。方法:处方量的盐酸左氧氟沙星、替硝唑、碳酸氢钠和枸橼酸等以混合制粒法压制泡腾片,采用高效液相色谱法测定盐酸左氧氟沙星、替硝唑含量。结果:盐酸左氧氟沙星和替硝唑的平均回收率分别为98.5%(RSD1.25%)和99.05%(RSD0.90%)。结论:口捷爽复方泡腾片的制备工艺简单,稳定性好,含量测定方法准确可靠,精密度高,可以对其进行质量控制。OBJECTIVE To prepare the effervescent tablets and to establish a method for quality control for this tablets. METHODS The tablets were prepared with mixture of levofloxacin hydrochloride, tinidazole, Sodium bicarbonate, tartaric acid, etc. The levofloxacin hydrochloride and tinidazole were determined by the HPLC. RESULTS The average recovery of levofloxacin hydrochloride and tinidazole was 98. 5 % （RSD 1.25 % ）and 99.05% （RSD 0. 90%） respectively. CONCLUSION This preparation method was easy to operate; the quality was stable and controllable.

关 键 词：盐酸左氧氟沙星 替硝唑 泡腾片 高效液相色谱法 质量控制 

分 类 号：R944[医药卫生—药剂学]