【摘要】 目的考察司帕沙星滴眼液的稳定性,确定其有效期。方法通过光照、高温、低温等影响因素试验,特定条件(40,50,60℃)下恒温15周加速试验及室温留样观察,测定其色泽、pH、含量、有关物质变化。采用高效液相色谱法测定含量及有关物质。结果采用恒温(恒湿)条件下15周内制剂的稳定性与室温留样观察结果一致。结论该制剂处方合理、质量稳定,有效期可达2年以上。更多还原

【Abstract】 Objective To observe the stability of the sparfloxacin eyedrops so as to determine its expiry date. Methods The change of color, pH value, ingredients and the change of related materials were detected through the trials under the influence factors including sunlight, high and low temperatures and accelerated test which was done under specified conditions of constant temperatures of 40℃, 50℃, 60℃for 15 weeks as well as samples which were observed under room temperature. The ingredients and related materials were measured by high performance liquid chromatography. Results The stability of the prescription was in accordance with the results of observation of samples under room temperature through 15 weeks of measurements by stability test under constant temperature and humidity. Conclusion The product has a reasonable prescription and stable quality. It may have an expiry date of more than 2 years.更多还原