茶碱缓释片的制备及其初步稳定性考察

目的：考察茶碱羟丙基甲基纤维素（HPMC）骨架片的制备方法及其初步稳定性。方法：以HPMC为骨架材料,采用湿颗粒法制备茶碱缓释片,考察了HPMC用量、HPMC黏度及释放介质pH值对药物体外释放行为的影响,以及光照、高温及高湿度对茶碱缓释片稳定性的影响。结果：HPMC用量和黏度显著影响茶碱释药速率,释放介质pH值对茶碱释药速率影响较小。光照、高温及高湿度不影响茶碱缓释片的含量及释放度。结论：通过使用合适黏度的HPMC及调节HPMC用量可获得具有理想释药行为的茶碱缓释片,且其稳定性良好。

Study on preparation and stability of theophylline sustained-release tablets

Objective： To investigate the preparation method and stability of theophylline hydroxypropylmethylcellulose （HPMC） matrix tablets. Methods： Theophylline sustained-release tablets were prepared using HPMC as the hydrophilic polymer by wet granulation method. The influence of amount and viscosity of HPMC as well as the pH value of release media on the releasing process of theophylline sustained-release tablets in vitro was investigated. The influence of illumination, high temperature and high relative humidity on the stability of theophylline sustained-release tablets was studied. Results： The rate of theophylline released from HPMC matrices was mainly controlled by the amount and viscosity of HPMC. The influence of the pH value of release media on the drug release was not significant. The illumination, high temperature and high relative humidity did not affect the content and in vitro release of theophylline sustained release tablets. Conclusion： Using the HPMC with suitable viscosity and adjusting the amount of HPMC, the theophylline sustained-release tablet with ideal release behavior and good stability can be obtained.