摘要
目的制备头孢他啶滴眼液并建立其质量控制方法。方法配制头孢他啶滴眼液,采用高效液相色谱法测定头孢他啶的含量,并考察其稳定性。结果所制备的制剂为无色至微黄色或微黄绿色的澄明液体,鉴别、检查均符合中国药典2010版中的相关规定;头孢他啶检测浓度的线性范围为50～300μg/ml(r=0.9999),平均回收率为100.2%,RSD为0.87%;本品对热不稳定,4℃可存放40d。结论该制备方法简便、可行,质量可控。本品应冷处避光保存。
Objective To prepare Ceftazidime eye drops and establish its quality control method. Methods Ceftazidime eye drops was prepared. The content of Ceftazidime was determined by HPLC. The stability of the preparation was investigated. Results The preparation was colourless to micro-yellow or yellowish green and in conformity with the description of China Pharmacopeia （ 2010 edition） in identification and test. The linear concent ration range of Ceftazidime was 50 ～ 300 μg/ml（ r = 0. 999 9） and the average recovery was 100. 2 % （ RSD = 0. 87% ）. Ceftazidime eye drops was unstable towards heat,while could be stored for 40 days at 4℃. Conclusion The preparative method is simple and feasible and the quality of the preparation is controllable. But the preparation should be stored at 2℃-10℃.
出处
《中国实用医药》
2010年第23期14-15,共2页
China Practical Medicine
关键词
头孢他啶
滴眼液
制备
质量控制
Ceftazidime
Eye drops
Preparation
Quality control
