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目的:研究复方莫西沙星滴耳液对实验动物的安全性及疗效。方法:皮肤刺激实验:20只家兔分为2组:皮肤完好组和皮肤破损组,每组10只,给家兔一侧涂复方莫西沙星滴耳液1ml,另一侧涂生理盐水1ml,均1次/d,连续涂药7d,对皮肤反应进行观察性评分。皮肤过敏实验:豚鼠30只,分为3组:复方莫西沙星滴耳液组、1%2.4-二硝基氯苯组及生理盐水组,每组10只,3组分别于豚鼠脱毛区各涂药0.5ml,于6、24、48和72h观察皮肤过敏反应。急性毒性实验:小鼠100只,分成复方莫西沙星滴耳液皮下注射组和腹腔注射组,每组50只,2个组各分5个剂量组:皮下注射组剂量分别为40、32、26、20和16ml/kg,腹腔注射组剂量分别为32、26、21、16和13ml/kg,给药后连续7d观察小鼠死亡情况,并计算LD50及95%可信限。疗效研究:中耳炎模型家兔30只,随机分为5组:复方莫西沙星滴耳液3个不同剂量治疗组、氧氟沙星滴耳液阳性对照组及空白对照组,每组6只。复方莫西沙星滴耳液3个不同剂量治疗组分别给予复方莫西沙星滴耳液0.8、0.5和0.2ml,均3次/d滴耳,阳性对照组给予氧氟沙星滴耳液0.5ml,3次/d滴耳,空白对照组不给药,治疗1周后对中耳炎疗效进行评价。结果:复方莫西沙星滴耳液未引起皮肤红斑、水肿及过敏反应;小鼠皮下及腹腔注射的LD50分别为25.55ml/kg和22.58ml/kg;与空白对照组比较,复方莫西沙星滴耳液3个剂量组与氧氟沙星组的显效率分别为83.3%～100%和66.6%。结论:复方莫西沙星滴耳液为治疗中耳炎的安全有效制剂。
Objective: To study the safety and efficacy of compound moxifloxacin ear drops on experimental animals. Methods: Skin irritation test: 20 rabbits were divided into 2 groups: skin intact group and skin lesion group, 10 rats in each group. One ml of compound moxifloxacin ear drops on one side of rabbits and 1 ml normal saline on the other side , Were 1 / d, continuous application of 7d, the skin reaction observed score. Skin allergy test: 30 guinea pigs were divided into 3 groups: compound moxifloxacin ear drops group, 1% 2.4-dinitrochlorobenzene group and normal saline group, 10 rats in each group, Apply 0.5ml and observe skin allergies at 6, 24, 48 and 72h. Acute toxicity test: 100 mice were divided into subcutaneous injection of compound moxifloxacin ear drops and intraperitoneal injection group, 50 in each group. The two groups were divided into five dosage groups: the subcutaneous injection groups were 40, 32, 26, 20 and 16 ml / kg respectively, and the intraperitoneal injection groups were 32, 26, 21, 16 and 13 ml / kg, respectively. The mice were sacrificed for 7 days and the LD50 and 95% confidence limits were calculated. Efficacy study: 30 rabbits with otitis media were randomly divided into 5 groups: 3 different doses of compound moxifloxacin ear drops, ofloxacin ear drops of the positive control group and blank control group, 6 in each group. Compound moxifloxacin ear drops 3 different doses of the treatment group were given compound moxifloxacin ear drops 0.8,0.5 and 0.2ml, 3 times / d drop ear, the positive control group was given ofloxacin ear drops 0.5ml , 3 times / d drops ear, the blank control group is not administered, after 1 week of treatment of otitis media evaluation. Results: The compound moxifloxacin ear drops did not cause skin erythema, edema and anaphylaxis. The LD50 of subcutaneous and intraperitoneal injection of mice was 25.55ml / kg and 22.58ml / kg respectively. Compared with the blank control group, The effective rates of the ear fluid 3 doses group and the ofloxacin group were 83.3% ~ 100% and 66.6% respectively. Conclusion: Compound moxifloxacin ear drops for the treatment of otitis media safe and effective preparation.