摘要
目的:制备乳酸环丙沙星耳用凝胶并建立其质量控制方法。方法:采用卡波姆940及CMC-Na为凝胶基质制备乳酸环丙沙星耳用凝胶,采用毛细管电泳法测定乳酸环丙沙星含量。结果:在一定条件下,乳酸环丙沙星与氢化可的松在20 min内能很好分离,线性范围为0.05～1.06 mg/mL,r=0.999 8,平均加样回收率为96.9%。结论:该制剂工艺合理,简单可行,质量可控,能满足临床用药需求。
Objective： To prepare ciprofloxacin lactate ear gel and to control the quality of the gel. Methods： The carbopol and CMC-Na were selected for the preparation of this gel. Ciprofloxaein lactate was determinate by HPCE. Results： Ciprofloxacin lactate was successfully separated within 20 minutes, the linear response range was 0.05 - 1.06 mg/mL, r = 0. 9998. The average recovery rate was 96.9%. Conclusions： The preparation technique of ciprofloxacin lactate ear gel is reasonable, simple, the quality can be controlled and the quality control method is accurate and fast.
出处
《儿科药学杂志》
CAS
2012年第11期40-42,共3页
Journal of Pediatric Pharmacy
