摘要
目的探讨地塞米松氯霉素滴眼液的有效期。方法用HPLC法测定地塞米松氯霉素滴眼液中地塞米松磷酸钠和氯霉素及氯霉素分解产物二醇物的含量,将产品用经典恒温法和室温留样观察法进行稳定性考察。结果地塞米松氯霉素滴眼液中的地塞米松磷酸钠和氯霉素的含量随温度升高和时间的延长呈线性下降,而氯霉素二醇物的含量则随温度升高和时间的延长而增加,经典恒温法测得氯霉素在25℃的贮存期为133天,地塞米松磷酸钠在25℃的贮存期为301天。室温留样观察实验证实:地塞米松磷酸钠放置1、3、5个月含量分别为99.3%、98.9%、97.7%,氯霉素放置1、3、5个月含量分别为98.2%、95.7%、88.5%。结论地塞米松氯霉素滴眼液的有效期暂定为4个月。
Objective To study the period of validity of Dexamethasone- Chloramphenicol eye drops. Methods The HPLC was used to detect the contents of Dexamethasone Sodium Phosphate and Chloramphenicol and its degradation product in Dexamethasone- Chloramphenicol eye drops. The samples were tested by classical constant temperature experiment and room temperature storage respectively. Results The contents of Dexametha- sone Sodium Phosphate and Chloramphenicol were linearly reduced with temperature rising and time prolonging, however, the change of the degradation product was reverse. The expiration of Chloramphenicol and Dexamethasone Sodium Phosphate were found to be 133 days and 301 days at 25℃, respectively, with classical constant temperature experiment. The contents of Dexamethasone Sodium Phosphate under room temperature storage was 99.3 % for 1 month , 98.9 % for 3 months and 97.7 % for 5 months, the contents of Chloramphenicol was 98.2 %, 95.7 % and 88.5 %, respectively. Conclusion This eye drops may be stored for 4 months at room temperature.
出处
《南华大学学报（医学版）》
2006年第1期106-108,共3页
Journal of Nanhua University(Medical Edition)
