摘要
目的制备盐酸莫西沙星耳用凝胶并建立其质量控制方法。方法以卡波姆-940为基质制备凝胶,采用高效液相色谱法测定盐酸莫西沙星含量,并考察其稳定性。结果盐酸莫西沙星进样量在0.4μg^3μg范围内与峰面积积分值线性关系良好(r=0.9999),平均回收率为99.82%(RSD=0.43%,n=9)。该制剂对家兔耳未见刺激性发生。结论本制剂制备工艺简单,质量控制易行,稳定性好,有良好的临床使用价值。
OBJECTIVE To prepare Moxifloxaein Hydrochloride Ear Gel and to establish a quality control method for the gel. METHODS The gel was prepared with carbopol 940 as base, the content of moxifolxacin hydroehioride was determined by HPLC and the stability of which was investigated. RESULTS The linear range of moxifloxacin hydroehioride was 0. 41~g ~ 3 p^g（ r = 0. 9999 ）, the average recovery was 99.82% （ RSD = 0. 43%, n = 9）. The result of irritation test showed that the ear gel had no irritation. CONCLUSION The present formula is ra- tional,and the preparation technology is simple and the method for quality control is feasible andstable.
出处
《海峡药学》
2013年第12期31-32,共2页
Strait Pharmaceutical Journal
关键词
盐酸莫西沙星
耳用凝胶
制备
质量控制
Moxifloxaein Hydrochlofide
Ear Gel
Preparation
Quality control
