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目的:制备茶碱缓释片剂,考察高分子缓释材料及片剂硬度对其释放度的影响。方法:调节乙基纤维素与羟丙甲纤维素的配比,制备不同的缓释片剂;再用优选配比的同一批颗粒分别压制成不同硬度的缓释片剂,测定其释放度。结果:缓释材料的配比不同,缓释片的释放度也不同,但片剂硬度不影响缓释片的释放度。结论:优选配比所制备的片剂,体外释药性能良好,适合于工业化生产。
OBJECTIVE: To prepare theophylline sustained-release tablets and investigate the influence of the hardness of the sustained release materials and the tablets on the release rate. Methods: The ratio of ethylcellulose and hypromellose was adjusted to prepare different sustained-release tablets. The same batch of granules with the same ratio were pressed into slow-release tablets with different hardness to determine the release . Results: The ratio of sustained-release material was different, the release of sustained-release tablets was also different, but the tablet hardness did not affect the release of sustained-release tablets. Conclusion: The tablets prepared according to the optimal ratio have good in vitro drug release performance and are suitable for industrialized production.