盐酸环丙沙星鱼肝油乳的制备及临床应用

Preparation and Clinical Application of Ciprofloxacin Hydrochloride Cod Liver Oil Emulsion

目的:制备盐酸环丙沙星鱼肝油乳并观察其对萎缩性鼻炎的临床治疗效果。方法:采用胶体磨制成盐酸环丙沙星鱼肝油乳,采用紫外分光光度法测定该制荆中盐酸环丙沙星的含量,测定波长277 nm;以复方鱼肝油滴鼻液为对照进行临床疗效观察。结果:制成的盐酸环丙沙星鱼肝油乳外观、性状、鉴别、检查均符合规定,稳定性良好;盐酸环丙沙星在2-10μ· ml-1范国内线性关系良好,回归方程A=0．090 4C+0．037 2,r=0．999 9;平均回收率为98．6％(n=3),RSD=1．23％;临床用于治疗萎缩性鼻炎,治疗组治愈率及总有效率分别为36．4％和84．8％,对照组分别为12．2％和49．0％,两组间比较均有显著性差异(P<0．01)。结论:该制剂制备方法简单,性质稳定,质量可控,临床应用安全、有效。

Objective： To prepare ciprofloxacin hydrochloride cod liver oil emulsion and to observe the clinical therapeutic effects of it on treating atrophic rhinitis. Method： The emulsion was prepared by using colloid mill. The content of ciprofloxacin hydrochloride of the emulsion was determined by UV-spectrophotometer at 277 nm. The stability of the product was tested. The clinical therapeutic effects were observed with compound cod liver oil nasal drops as controlled group. Result： The shape and properties of the emulsion were accord with the standard, and the stability was good. The calibration curve of ciprofloxacin hydrochloride was linear in the range of 2-10μg· ml^-1, The average recovery rate was 98.6% （n = 3 ）, RSD = 1.23%. The RSDs for inter-day and intra-day in sample of 10,6,2 μg·ml^-1 were less than 3%. The curative rate and total effective rate were 36.4% and 84.8% for trial group and 12.2% and 49.0% for control group respectively in treating atrophic rhinitis. The differences were significant between two groups （ P 〈 0.01 ）. Conclusion： This preparation is simple in preparation technique, stable in quality, and reliable in quality control. The product is safe and effective in clinical application.