【摘要】 目的:评价氧氟沙星滴眼液国产品东康明(A)与进口品泰利必妥(B)的产品质量。方法:在2800lx光照10d及温度40℃,50℃,60℃,相对湿度(RH)75%条件下考察180d,用高效液相色谱法测定含量变化,比较产品稳定性;观察两者对细菌性感染结膜炎、角膜炎的临床疗效和细菌清除率。结果:2800lx光照10d,A含量由99.80%降至94.12%,B含量由100.3%降至98.86%(P<0.05);A有效期(保质期)为3.27年,B则为3.41年,均为3年以上(P>0.05);A与B总有效率分别为91.43%和88.57%,细菌清除率分别为96.77%和96.67%(P>0.05)。结论:国产品和进口品质量稳定性与临床疗效均相似。更多还原

【Abstract】 Objective:To study the differences of Doncomin (A) made in China and Tiaribite (B) imported from Japan for ofloxacin eye drops.Methods:To determine A and B by HPLC.To compare the stability in 2 800 lx for 10 d and 40℃,50℃,60℃,RH 75%,for 180 d. Clinical study and comparison of 35 patients(conjunctivitis and corneitis) with bacterial infections were performed.Efficacy evaluations included clinical response and bacterial eradication rates.Results:The contents in 2 800 lx reduced from 99.80% to 94.12% for A and from 100.3% to 98.86% for B (P < 0.05),respectively.According to determination in 40℃,50℃,60℃,RH 75%,for 180 d,the expiry date (shelf life) was 3.27 years for A and 3.41 years for B,respectively.Overall efficacy rate was 91.43% for A and 88.57% for B.Bacterial eradication rate was 96.77% for A and 96.67% for B(P < 0.05),respectively.Conclusion:Domestic Doncomin is similar to imported Tiaribite in quality,stability and efficacy.更多还原