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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 auricular lactate and establish its quality control method. METHODS: Ciprofloxacin lactate gels were prepared by using Carbomer 940 and CMC-Na as gel matrix. The content of ciprofloxacin lactate was determined by capillary electrophoresis. Results: Under certain conditions, ciprofloxacin lactate and hydrocortisone could be well separated within 20 min. The linear range was 0.05-1.06 mg / mL, r = 0.999 8, and the average recovery was 96.9%. Conclusion: The preparation process is reasonable, simple and feasible, quality control, to meet the needs of clinical medication.