论文部分内容阅读
目的:考察复方硫酸庆大霉素口腔溃疡凝胶剂的稳定性。方法:采用光照、低温和室温留样观察和台阶式升温试验法,测定复方硫酸庆大霉素口腔溃疡凝胶剂的内控指标;采用抗生素微生物检定法测定庆大霉素含量。结果:在光照、低温(2~10℃)、室温留样观察情况下,硫酸庆大霉素的含量在合格标准内,长时间留样其外观显微黄色;采用台阶式升温法试验在50℃以上其含量不合格,外观显黄色。结论:本品光照10天、低温6月内和留样观察4月内和台阶式升温法(温度为50℃内)都在合格标准范围内,在低温(2~10℃)状态下可以贮存180 d。
Objective: To investigate the stability of compound gentamicin oral ulcer gel. Methods: The internal control indexes of compound gentamicin oral cavity ulcer gels were determined by light observation, low-temperature and room-temperature sample observation and step-warming method. The gentamicin content was determined by antibiotic microbe test. Results: Under the illumination, low temperature (2 ~ 10 ℃) and room temperature, the content of gentamicin sulfate was within the acceptable standard, and the appearance of the gentamicin sulfate was yellowish for a long time. Using the step - ℃ above its unqualified content, the appearance of significant yellow. Conclusion: This product is light for 10 days, low temperature in June and stay samples observed in April and step heating method (temperature is within 50 ℃) are in the acceptable standard range, at low temperature (2 ~ 10 ℃) state can be stored 180 d.