[关键词]
[摘要]
目的 考察各处方和工艺因素对以羟丙基甲基纤维素 (HPMC)为骨架材料的青藤碱缓释片中药物释放的影响。方法 采用不同黏度级 (K4 M,K15 M和 K10 0 M)和不同用量 HPMC及不同的制备工艺制备青藤碱缓释片。结果 不同黏度级的 HPMC在用量为 30 %时对青藤碱的释放度影响不大 ;当 HPMC的用量小于 30 %时,随着HPMC用量增大,释放速度减慢,但 HPMC的用量大于 30 %时释放速度变化不明显 ;当青藤碱和 HPMC的比例为1: 1.5时,片重从 2 80 mg增大到 36 0 mg,青藤碱释放速度减慢 ;HPMC粒度及片剂的硬度对青藤碱的释放速度影响较小。结论 制备青藤碱缓释片应考虑选择合适的片重及 HPMC的用量。
[Key word]
[Abstract]
Object To study the preparation and technology on sinomenine (SM) release from Sinomenine Sustained-release Tab lets (SSTs) in which hydroxyp ropylmethyl cellulose (HPMC) was used as the primary excipients. Methods SSTs were prepared with different HPMC viscosity of K4M, K15M, and K100M, different HPMC content, and preparing technology.Results Little effect was observed on the releasing rate of SM with different HPMC viscosity when the content of HPMC was 30%. SM releas-ing rate increased with the decreasing of proportion of HPMC while the content of HPMC was less than30%. But the releasing velocity slowed down while the content of HPMC increased and the effect on the releasing ratew as not found as the content of HPMC was over 30%. When the ratio of SM and HPMC was 1:115, the releasing rate decreased with the increasing of tablet weight from 280 mg to 360 mg. The re-leasing rate was in sensitive to the particle size of HPMC and hardness of SSTs in this study. Conclusion It is necessary to control the tablet weight and choose the proper quantity of HPMC in the preparation of SSTs.
[中图分类号]
[基金项目]