复方司帕沙星滴鼻液的制备及其稳定性考察

目的:制备复方司帕沙星滴鼻液并考察其稳定性。方法:选择稀配法配制滴鼻液;采用紫外-可见分光光度法及旋光法测定其中主药含量,并考察室温留样6mo内的药物浓度及其稳定性,同时用家兔做鼻黏膜刺激性实验。结果:司帕沙星检测浓度线性范围为2.0~9.0μg.mL-1(r=0.9999),平均回收率司帕沙星为99.19%(RSD=1.77%),盐酸麻黄碱为100.21%(RSD=2.12%);该制剂对鼻黏膜的刺激性小,室温贮存6mo内质量稳定。结论:该制剂制备及含量测定方法简单可行,且质量稳定、刺激性小,易于推广。

Preparation and Stability Study of Compound Sparfloxacin Nasal Drops

OBJECTIVE:To prepare compound sparfloxacin nasal drops and to investigate the stability of this preparation.METHODS:Compound sparfloxacin nasal drops were prepared with distilled water as diluents,and the concentration of the chief component were determined by ultraviolet-visible spectrophotometer.The concentration and stability of the sample preparation were investigated after storage for 6 months at room temperature.Meanwhile nasal mucosa stimulus property test was performed on rabbits.RESULTS:The linear range of sparfloxacin was 2.0～ 9.0μ g.mL-1(r=0.999 9),with average recovery at 99.19%(RSD=1.77%),and that of ephedrine hydrochloride was 100.21%(RSD=2.12%).The preparation showed a minor stimulation on nasal mucosa and was stable in quality within 6 months after storage at room temperature.CONCLUSION:The preparation is simple and practical in preparation and determination,stable in quality and minor in stimulation,thus deserving to be popularized.