目的:检测口灵药膜的小鼠急性毒性,探讨口灵药膜的抗感染作用及作用机理。方法:通过小鼠口灵药膜最大剂量最大浓度灌胃给药,2次/d,观察7d内的急性毒性反应;小鼠随机分为口灵药膜低、中、高药物组和空白组,通过测量腹腔液伊文思蓝的吸收度观察口灵药膜对毛细血管通透性的影响。结果:给药后小鼠全部存活,观察期内未见明显毒性反应,小鼠口服口灵药膜最大耐受量相当于60kg人临床日用量的400倍;口灵药膜各实验组小鼠腹腔液伊文思蓝含量和基质对照组有显著性差异(P<0.01)。结论:口灵药膜临床应用是安全的,口灵药膜对毛细血管通透性模型的抗炎作用显著。 OBJECTIVE: To detect the acute toxicity of oral medicine in mice and to investigate the anti-infective effect and mechanism of the oral film. METHODS: Mice were given intragastric administration at the maximum dose maximum concentration twice a day. The acute toxicity was observed within 7 days. The mice were randomly divided into low, medium, and high drug groups and blank groups. The effect of oral pellicle membrane on capillary permeability was measured by measuring the absorption of Evans blue in peritoneal fluid. RESULTS: After administration, all mice survived, and no obvious toxic reaction was observed during the observation period. The maximum tolerated dose of orally administered medicated film in mice was equivalent to 400 times the clinical dosage of 60 kg for humans; Evans blue content in peritoneal fluid was significantly different from the matrix control group (P<0.01). Conclusion: The clinical application of the oral medicine film is safe, and the anti-inflammatory effect of the oral film on the capillary permeability model is significant.