氧氟沙星耳用滴丸制备.docVIP

氧氟沙星耳用滴丸制备 　【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) 　　［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3 cm、滴头温度80 ℃、滴距5 cm、冷凝液温度15 ℃。氧氟沙星溶液在302 nm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=229.398 1H-0.120 8，r=0.999 8（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。 　　［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) 　　The Preparation of Ofloxacin Ear Drop Pills 　　WANG Rongjun，An Yiguo(Anhui Provincial Friendship Hospital，Hefei, Anhui 230011，China) 　　Abstract：Objective The preparation of ofloxacin ear drop pills.Methods Parallel tests were conducted on the 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 drug 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 UVabsorbance spectorphotometry high (H) in 302 nm:C=229.398 1H0.120 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. 　　Key words：Ofloxacin;Ear drop pills;Orthogonal test;The first order derivative spectorphotometry;Polyglycol(PEG) 　　氧氟沙星是第3代喹诺酮类药物，具有抗菌谱广、高效、低毒等优点。为了扩大氧氟沙星的应用范围，优化其治疗效果，满足临床需要，我们研制了氧氟沙星耳用滴丸。其具有起效快直达病灶，生物利用度高，避免胃肠反应和肝脏首过效应［1］；药物在病灶滞留时间长，发挥缓效长效作用；局部药物浓度高、用药次数少、不流淌等优点。特别适合渗出性和化脓性中耳炎，具有释药快、无油腻感、易清洗、稳定性好、应用方便等特点。由于经济性等原因，目前未见药厂生产此药