氧氟沙星耳用滴丸的制备  

The Preparation of Ofloxacin Ear Drop Pills

作　　者：汪荣军[1] 安益国[1] 

机构地区：[1]安徽省立友谊医院,安徽合肥230011

出　　处：《实用医技杂志》2006年第10期1611-1613,共3页Journal of Practical Medical Techniques

摘　　要：目的:制备氧氟沙星耳用滴丸。方法:以成型率及重量合格率作为评价指标,对滴头及冷凝液的温度、贮药槽药液高度、滴距4因素进行正交试验并确定其最佳成型工艺。一阶导数光谱法测定氧氟沙星主要的含量。结果:最佳成型工艺为贮药槽药液高度3cm、滴头温度80℃、滴距5cm、冷凝液温度15℃。氧氟沙星溶液在302nm波长处紫外吸收一阶导数光谱,振幅值(H)和氧氟沙星浓度(C)有线性关系:C=229.3981H-0.1208,r=0.9998(n=6);平均回收率为100.73%,RSD=0.80%(n=3)。结论:该制剂制备工艺简单、稳定性好,质量控制方法简易、快速、可行。Objective The preparation of ofloxacin ear drop pills. Methods Parallel tests were conducted onthe rate of qualified shape and the rate of qualified weight as the index of evaluation, the orthogonal test was conducted on the 4 factors, including the temperature of drops and the liquor condensate, the drug height in the drug storage tank and the dropping distance,accordingly the optimum forming technics were selected. The content of ofloxacin of main drug was determined with the first order derivative spectrophotometry. Results The optimum forming technics could be seen as follows, the height of the drdg storage tank was 3 cm, the temperature of drops was 80℃, the dropping distance was 5 cm and the temperature of the liquor condensate was 15℃. The concentration （C） of ofloxacin had a linear relationship with the first order derivative UV absorbance spectorphotometry high （H） in 302 nm：C=229. 398 1H-0. 120 8,r=0. 999 8（n=6） ;The average rate of recovery was 100.73% and RSD was 0.80% （n=3）. Conclusion The preparation is simple in preparation, good in stability; and the quality control method is simple and easy, rapid, accurate and feasible.

关 键 词：氧氟沙星 耳用滴丸 正交实验 一阶导数光谱法 聚乙二醇(PEG) 

分 类 号：R943[医药卫生—药剂学]