粗叶悬钩子总生物碱骨架缓释片的制备及体外释放特性

Preparation of sustained-release total alkaloids tablets of Runus alceaefolius Poir and its release property in vitro

目的:确定粗叶悬钩子总生物碱缓释片的制备工艺,并进行其释放特性的研究。方法:以羟丙甲基纤维素为骨架材料,采用湿法制粒压片制备缓释片,用紫外分光光度法测定主药的含量。通过测定其体外释放度,进行释放机制及影响因素的研究。结果:所制备的粗叶悬钩子总生物碱缓释片质量稳定,体外释放性能好,持续释药达12h,符合设计要求,体外释放符合Higuchi方程。结论:方法简便,结果可靠,可作为粗叶悬钩子总生物碱缓释制剂生产过程的质量控制依据。

OBJECTIVE To prepare sustained release total alkaloids tablets of Rumsalceaefolius Poir. and evaluate its drug release property. METHODS The hydrophilic matrix hydroxypropyl methylcellulose（HPMC）was used to prepare sustained release tablets by the wet granule compression technique. The content of the major drug was determined by UV spectrophotom etry at 415 nm. The release mechanism and the influence factors were studied by determining the dissolution. RESULTS The drug release complied with the requirement of the Chinese Pharmacopoeia and the drug was sustained released in vitro over 12 h. The release of sustained-release total alkaloids tablets of Runus alceaefolius Poir. was conformed to Higuchi equation. CONCLUSION The method is simple and results are reliable. It can be used for quality control.