摘要
目的：制备氯霉素凝胶剂并建立其质量控制方法。方法：以氯霉素为主药,以卡波姆-940为凝胶基质,制备氯霉素凝胶剂;采用高效液相色谱法测定氯霉素的含量,测定波长为277 nm。结果：该品为无色透明、均匀细腻的凝胶,质量符合2010年版《中国药典》中的相关规定;氯霉素浓度在39.84～249.00μg/m L范围内线性关系良好（r=0.999 9）,平均回收率为100.3%（RSD=0.81%）。结论：该处方工艺简单、实用,质量控制方法可靠、易行。
Objective： To investigate the preparation of chloramphenicol gel and establish the methods ior its quality control. Methods： Chloramphenieol gel was prepared by using chloramphenicol as a main drug and earbopoler 940 as gel matrix. The concentration of chloramphenicol in the gel formulation was determined by HPLC at the detection wave length of 277 nm. Results ：The prepared formulation was a colorless transparent gel and its quality met the relevant requirements in Chinese Pharmacopoeia in 2010 edition. The concentration of chloramphenicol was determined by HPLC and its linear range was 39.84-249.00 μg/mL （r=0.999 9）. The average recovery rate was 100.3% （RSD =0.81%, n =9）. Conclusion：The preparation of chloramphenieol gel is simple and practical, and the quality control methods are reliable and simple.
出处
《天津医科大学学报》
2015年第5期446-448,共3页
Journal of Tianjin Medical University
关键词
氯霉素
凝胶剂
制备
质量标准
chloramphenicol
gel
preparation
quality control
