Preparation of Oroxylum Indicum Buccal Tablets / 中国药师

ABSTRACT

To prepare oroxylum indicum ( OLI) buccal tablets. Methods:The extract of oroxylum indicum as the main component, the buccal tablets were prepared using a wet granulation compression method. According to the results of single factor ex-periments, an orthogonal design was used to select the optimal formula based on the appearance, taste, disintegration time and friabili-ty. The average weight variation and average disintegration time were tested to evaluate the quality of three batches of the buccal tablets with the optimized formula. Results:The optimal formula was composed of 50%mannitol, 5%sucrose-stevioside (100∶1), 5% pep-permint oil and 35%PVP-K30-85% ethanol (6∶10). For the three batches of the buccal tablets with the optimized formula, the aver-age weight variation was (1. 83 ± 0. 29) % and the average disintegration time was(14. 7 ± 0. 6) min, which met the requirements of quality control on buccal tablets in Chinese pharmacopoeia. Conclusion:The optimal formula and process of OLI buccal tablets show fine reproducibility and stability.