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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 Preparation of ceftazidime eye drops, determination of ceftazidime by high performance liquid chromatography, and investigate the stability. Results The preparations were colorless to yellowish or yellowish-green clear liquid. The identification and inspection were in accordance with the relevant regulations of Chinese Pharmacopoeia 2010. The linear range of ceftazidime was 50 ~ 300μg / ml (r = 0.9999) , The average recovery was 100.2%, RSD 0.87%; This product is unstable to heat, 4 ℃ can be stored for 40 days. Conclusion The preparation method is simple, feasible and quality controllable. This product should be cold dark place preservation.