| 引用本文: | 姬怀雪1，王艳1，王涛1，邵珠民1，吕冬梅1，邱述玲1，李相涛1，赵国东2.乳酸环丙沙星壳聚糖滴鼻剂的制备及质量控制[J].中国现代应用药学,2009,(9):750-752. |
| JI Huaixue1, WANG Yan1, WANG Tao1, SHAO Zhumin1, LV Dongmei1, QIU Shuling1, LI Xiangtao1, ZHAO Guodong2.Preparation and Quality Control of Ciprofloxacin Lactate Chitosan Nasal Drop[J].Chin J Mod Appl Pharm(中国现代应用药学),2009,(9):750-752. |
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| 摘要: |
| 目的研制乳酸环丙沙星壳聚糖滴鼻剂并建立其质量控制方法。方法以壳聚糖为增稠剂、增效剂，乳酸环丙沙星为主药制备滴鼻剂。采用反相高效液相色谱法测定主药含量，并对其稳定性进行考察。 结果所制备的制剂为无色、微粘、澄明液体, 其鉴别符合中国药典2005版中的相关规定；乳酸环丙沙星在10～200 μg·mL-1内线性关系良好(r=0.999 9)。平均回收率为99.19%，RSD为0.94%。日内RSD为0.53%, 日间RSD为1.14%。结论本制剂制备工艺简单可行，质量稳定、可靠，控制方法灵敏、准确。 |
| 关键词: 乳酸环丙沙星 壳聚糖 制备 质量控制 |
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| Preparation and Quality Control of Ciprofloxacin Lactate Chitosan Nasal Drop |
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JI Huaixue1, WANG Yan1, WANG Tao1, SHAO Zhumin1, LV Dongmei1, QIU Shuling1, LI Xiangtao1, ZHAO Guodong2
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| Abstract: |
| OBJECTIVE To prepare ciprofloxacin lactate chitosan nasal drop and establish its quality control method. METHODS The nasal drop was prepared using chitosan as thicken agent and synergist with ciprofloxacin as principal agent. The content of ciprofloxacin was determined by RP-HPLC. The stability of the preparation was investigated as well. RESULTS The prepared nosal drop was colorless transparent glutinous limpid liquid with its identification items all up to the relate standards stipulated in Ch.P (2005). The linear range of ciprofloxacin was 10～200 μg·mL-1(r=0.999 9). The average recover was 99.19%, RSD was 0.94%. The average RSD of intra-day and inter-day was 0.49% and 1.50%. CONCLUSION The preparation technology is simple and feasible. The quality of preparation is stable and controllable. The method of quality control is rapid and accurate. |
| Key words: ciprofloxacin lactate chitosan preparation quality control |
