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乳酸环丙沙星壳聚糖滴鼻剂的制备及质量控制

Preparation and Quality Control of Ciprofloxacin Lactate Chitosan Nasal Drop
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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10~200μg·mL-1内线性关系良好(r=0.9999)。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。 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.
出处 《中国现代应用药学》 CAS CSCD 北大核心 2009年第9期750-752,共3页 Chinese Journal of Modern Applied Pharmacy
关键词 乳酸环丙沙星 壳聚糖 制备 质量控制 ciprofloxacin lactate chitosan preparation quality control
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