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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 develop ciprofloxacin lactate nasal drops and establish its quality control method. Methods nasal drops were prepared by using chitosan as thickening agent, synergist and ciprofloxacin lactate as main drug. The main drug content was determined by RP-HPLC and its stability was investigated. Results The prepared preparations were colorless, slightly viscous and clear liquid. The identification was in accordance with the relevant provisions of Chinese Pharmacopoeia 2005 edition. The linear relationship of ciprofloxacin lactate with 10 ~ 200 μg · mL-1 was good (r = 0.9999). The average recovery was 99.19% with a RSD of 0.94%. Day RSD was 0.53% and daytime RSD was 1.14%. Conclusion The preparation process is simple and feasible, the quality is stable and reliable, the control method is sensitive and accurate.