摘 要:
普多沙星是一种专用于犬、猫细菌感染的新型动物专用氟喹诺酮类药物,以普多沙星为主药,以羧甲基纤维素纳、甘油、丙二醇的用量及pH为考察因素,以凝胶剂的涂展性、均匀度、离心性为指标进行综合评分,筛选优化处方,制备普多沙星凝胶剂,并对其进行质量控制研究。采用紫外分光光度法测定普多沙星的含量。优化处方为CMC-Na 50g/L、甘油160mL/L、丙二醇200mL/L、pH 6.7。检测波长282nm,普多沙星在2μg/mL~10μg/mL与吸收度呈良好的线性关系,R2=0.999 7,平均回收率为98.02%,RSD=0.15%(n=5),所制得的凝胶稳定性良好,无变化。表明该凝胶剂制备方法简单,稳定性好,质量可控,各项指标符合凝胶剂的质量标准。
译 名:
Study on Preparation and Quality Control of Pradofloxacin Gel
作 者:
FENG Xiao-lan;WEI Xue-qi;LIU Li;SHAO Zheng-qi;LIU Xiao-qiang;College of Veterinary Medicine,Northwest A&F University;
关键词:
pradofloxacin;;gel;;quality examination
摘 要:
Pradofloxacin is a novel veterinary fluoroquinolone antibacterial agent for use against bacterial infections in dogs and cats.To prepare the pradofloxacin gel and examine the initial quality,the pradofloxacin gel was prepared through the orthogonal design to optimize the prescription,in which the spreading ability,uniformity and the centrifugal resisting were evaluated comprehensively as indexes,with the amount of CMC-Na,glycerol,propylene glycol and pH value as observing factors.The content of pradofloxacin was determined by UV spectrophotometer.The prescription optimized was composed of 5% CMC-Na,16% of glycerol,20% propylene glycol and pH was 6.7.Pradofloxacin was linear in the range of 2μg/mL-10μg/mL with the correlation coefficient of 0.9997 and average recovery was 98.02% with RSD 0.15%(n=5).The preparing method was simple,the gel was stable,and the quality of gel is controllable.The indexes were accordant with the standard of gel.