复方司帕沙星滴鼻液的制备及其稳定性考察

Preparation and Stability Study of Compound Sparfloxacin Nasal Drops

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：该制荆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。

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 2.0-9.0μg·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.