复方氧氟沙星酮替芬鼻用喷雾剂的制备及质量控制

目的:制备复方氧氟沙星酮替芬鼻用喷雾剂并建立其质量控制方法。方法:以氧氟沙星、富马酸酮替芬、盐酸麻黄碱为主药制备鼻用喷雾剂;采用高效液相色谱法测定其中主药含量。结果:该制剂各项检查均符合鼻用喷雾剂的有关规定;检测浓度氧氟沙星在30～300mg.L-1(r=0.9999)、富马酸酮替芬在20～200mg.L-1(r=0.9998)、盐酸麻黄碱在100～1000mg.L-1(r=0.9998)范围内呈良好的线性关系,平均回收率分别为99.29%(RSD=1.08%)、100.1%(RSD=1.61%)、99.98%(RSD=1.23%)。结论:本制剂制备工艺简单,性质稳定,质量可控。

Preparation and Quality Control of Compound Ofloxacin and Ketotifen Nasal Sprays

OBJECTIVE:To prepare the compound ofloxacin and ketotifen nasal sprays and establish a method for its quality control.METHODS:The nasal sprays was prepared by taking ofloxacin,ketotifen fumarate and ephedrine hydrochloride as main components.The contents were determined with high-performance liquid chromatography.RESULTS:The nasal sprays pH value was 4.5-5.5,and other tests accord with the requirements of nasal sprays.The linear range of the ofloxacin was 30～300mg·L-1(r=0.999);that of ketotifen fumarate was 20～200mg·L-1(r=0.999 8);and that of ephedrine hydrochloride was 100～1 000mg·L-1(r=0.999 8).The average recoveries of ofloxacin,ketotifen fumarate and ephedrine hydrochloride were 99.29%(RSD=1.08%),100.1%(RSD=1.61%)and 99.98%(RSD=1.23%),respectively.CONCLUSIONS:The preparation is simple in process technique,stable in properties and controllable in quality.