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目的:采用湿法制粒制备茶叶口含片并优化其制备工艺。方法:通过单因素试验对各种辅料的用量进行了考察;以口感、崩解时限作为考察指标,采用正交试验设计法优化处方。结果:最佳处方为老叶茶叶提取物30 g、甘露醇60 g、PEG6000 20 g、阿斯巴甜10 g、柠檬酸10 g、薄荷脑1 g。所制得口含片外观、硬度、崩解时限等指标均符合药典规定。结论:该茶叶含片的制备工艺合理可行。
OBJECTIVE: To prepare tea leaf tablets by wet granulation and to optimize its preparation process. Methods: The dosage of all kinds of excipients was investigated by single factor test. Tasting time and disintegration time were taken as the indexes of investigation. The orthogonal test design was used to optimize the prescription. Results: The best prescription was the old leaf tea extract 30 g, mannitol 60 g, PEG6000 20 g, aspartame 10 g, citric acid 10 g, menthol 1 g. The prepared ointment appearance, hardness, disintegration time and other indicators are in line with Pharmacopoeia regulations. Conclusion: The preparation of tea leaf tablets is reasonable and feasible.