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采用空白载体作对照,从安全性、有效性、皮肤刺激性和致敏性、单剂量和多剂量药代动力学等方面评价5%Amlexanox口腔糊剂(Aphthasol)局部治疗轻型复发性阿弗它溃疡的药代动力学特点和临床安全性。 结果表明:991例轻型阿弗它溃疡患者应用5%Amlexanox局部治疗28d后,仅出现极少的不良反应,无明显刺激性和致敏性。药代动力学研究显示,患者血清中Amlexanox浓度升高,更主要是通常的胃肠道吸收,仅有少部分由溃疡处直接吸收,局部应用100mg5%Amlexanox 2.4h后,平均血清浓度为120ng/ml,
Blank carriers were used as a control to evaluate the topical treatment of 5% Amlexanox buccal mucosa (Aphthasol) for light-onset recurrent aflatoxin in terms of safety, efficacy, skin irritation and sensitization, single- and multi-dose pharmacokinetics, Pharmacokinetic characteristics and clinical safety of ulcers. The results showed that there were only a few adverse reactions, no irritation and sensitization in 991 cases of patients with light afular ulcer after 28 days of topical treatment with 5% Amlexanox. Pharmacokinetic studies have shown that serum concentrations of Amlexanox in patients with elevated, more commonly gastrointestinal absorption, only a small part of the direct absorption by the ulcer, Topical application of 100mg5% Amlexanox 2.4h, the average serum concentration of 120ng / ml,