论文部分内容阅读
目的:考察司帕沙星眼用凝胶的稳定性,并预测其室温贮存的有效期。方法:采用紫外分光光度法测定凝胶中司帕沙星的含量,分别在低温、高温、高湿及光照条件下放置,于规定时间取样,测定样品pH及含量,观察样品的外观变化,采用初匀速法预测其有效期。结果:司帕沙星眼用凝胶在低于40℃下较稳定,强光照及高温(60℃)下主药含量下降明显,湿度影响不明显。初匀速法试验预测,本品在25℃下的有效期为1.86年。结论:司帕沙星眼用凝胶在室温避光下稳定。
OBJECTIVE: To investigate the stability of sparfloxacin ophthalmic gel and to predict its shelf life at room temperature. Methods: The content of sparfloxacin in the gel was determined by UV spectrophotometry. The samples were placed under low temperature, high temperature, high humidity and light conditions respectively. Samples were taken at specified time to determine the pH and content of the sample. The appearance of the samples was observed. Early uniform velocity prediction of its validity. Results: Sparfloxacin ophthalmic gel was stable at below 40 ℃. The content of main drug decreased obviously under high light and high temperature (60 ℃), with no significant effect of humidity. Uniform uniform speed test predicted that the product at 25 ℃ for a period of 1.86 years. Conclusion: Sparfloxacin ophthalmic gel is stable against ambient light at room temperature.