桃红四物汤总生物碱缓释片的制备及其体外释放度的研究

目的：确定桃红四物汤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,湿法制粒压片制备缓释片,采用紫外分光光度法测定主药的含量,检测波长为302nm;通过正交试验法,根据体外释放速率进行筛选与优化处方,确定最佳处方。结果：所制备的桃红四物汤总生物碱缓释片质量稳定,体外释放性能好,持续释药12h,符合设计要求。结论：本法简便,结果可靠,可作为桃红四物汤总生物碱缓释制剂生产过程的质量控制方法。

Study on preparation of Total Alkaloids Sustained-release Tablets of Taohong Siwu Decoction and its release property in vitro

Objective： To prepare Total Alkaloids Sustained-release Tablets of Taohong Siwu Decoction and evaluate its drug release property in vitro. 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 spect-rophotometry at 302 nm. The optimal formulation and technology of the Tablets were studied with orthogonal test. Results： The drug release complied with the requirement of the Chinese Pharmacopoeia （2005） and the drug was sustained released in vitro over 12 h. Conclusion： The method is simple and results are reliable. It can be used for quality control.