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目的:以大叶小檗根和木蹄层孔菌子实体为原料,根据中药配伍理论,采用制剂学方法研制了小檗木蹄口腔溃疡药膜。方法:以成型性、外观、柔软度、韧性的综合评分为指标,选择淀粉、羧甲基纤维素钠、甘油、炼蜜用量为考察因素,通过正交试验优选小檗木蹄口腔溃疡药膜的配方。通过建立大鼠口腔溃疡动物模型进行了该膜剂的药效学研究,将大鼠随机分为空白组、模型组、阳性组、小檗木蹄口腔溃疡药膜高、中、低剂量组。阳性组用蜂胶口腔膜给药,每只每次1片,1 d内分2次给药。小檗木蹄口腔溃疡膜高剂量组1 d内分4次给药(4片)。小檗木蹄口腔溃疡膜中剂量组1 d内分2次给药(2片)。小檗木蹄口腔溃疡膜低剂量组每天1次给药(1片),均连续给药7 d。结果:膜剂最佳配方为大叶小檗提取物浸膏-木蹄层孔菌提取物浸膏-淀粉-羧甲基纤维素钠-甘油-炼蜜-水(8∶4∶10∶2∶3∶20∶500),此配方下,该药膜的各评价指标的评分为成型性23.6分,外观23.8分,柔软度22.5分,韧性23.3分。该膜剂对于治疗大鼠口腔溃疡效果明显,愈合率很高。结论:制得的小檗木蹄口腔溃疡药膜具有抑菌消炎、促进愈合的作用,治疗口腔溃疡效果明显。
OBJECTIVE: According to the compatibility theory of traditional Chinese medicine (TCM), the pharmacopoeia of Berberis hoofed buccal ulcer was prepared by using the solid substances of Berberis rhizome and Fusarium. Methods: Taking the comprehensive score of formability, appearance, softness and toughness as indexes, the factors such as starch, sodium carboxymethylcellulose, glycerin and honey were selected as the investigation factors. Through the orthogonal test, Formula The animal model of oral ulcer was established to study the pharmacodynamics of the film. The rats were randomly divided into blank, model group, positive group and Berberis hoof mouth ulcers in high, medium and low dose groups. Positive group with propolis oral membrane administration, each 1 each, 1 d sub-2 administration. Berberis wood mouth ulcer membrane high-dose group 1 d dosing 4 times (4 tablets). Berberis wood mouth ulcer membrane dose group 1 d within 2 dosing (2 tablets). Berberis wood mouth ulcer membrane low-dose group once a day (1 tablet), were administered for 7 days. Results: The optimal formulation of the film was berberine extract extract - Fusarium hoofed extract - starch - sodium carboxymethyl cellulose - glycerol - refining honey - water (8:4:10:2:3 : 20: 500). Under the formula, the score of each evaluation index of the medicinal film was 23.6 points for appearance, 23.8 points for appearance, 22.5 points for softness, and 23.3 points for toughness. The film for the treatment of oral ulcers in rats obvious effect, a high rate of healing. Conclusion: The berberine hoof-mouth ulcer drug film has antibacterial and anti-inflammatory effects and healing effects, and has obvious effect on treating oral ulcer.