摘要
目的探讨红霉素眼膏质量控制方法并确定其有效期。方法通过初步稳定性考察的影响因素试验,对光照、高温、高湿及室温放置条件下的样品进行考察,观察其外观性状的变化,采用抗生素微生物检定法测定主药含量的变化情况。结果各批红霉素眼膏的性状及含量均符合规定。结论红霉素眼膏具有较好的稳定性,其有效期可初步确定为2年。
Objective To control the quality and to ascertain the expiry date of erythromycin eye ointment. Methods Through influential factor stability experiment to inspect the change of appearance character under the condition of illumination, high temperature and moist, room temperature. Through the method of microorganism assay to determine the change of content. Results The character and content of all experiment groups were consistent with regulation. Conclusion The results of stability research showed that erythromycin eye ointment has a good stability and its expiry date of 2 years is ascertained preliminaryly.
出处
《中国药业》
CAS
2008年第11期45-46,共2页
China Pharmaceuticals
关键词
红霉素眼膏
稳定性
微生物检定
有效期
erythromycin eye ointment
stability
microorganism assay
expiry date
