三清降糖方总苷缓释片的处方优化  

Formulation Optimization of Total Glycosides Sustained-release Tablets of Sanqing Jiangtang Decoction

作　　者：吕立勋[1] 李唐棣[1] 吴范武[2] 

机构地区：[1]河北联合大学药学院,唐山063000 [2]河北联合大学中医学院,唐山063000

出　　处：《医药导报》2013年第9期1217-1220,共4页Herald of Medicine

基　　金：2011年唐山市科技支撑项目(1113020112a)

摘　　要：目的优选三清降糖方总苷缓释片的处方和工艺,并考察其释放特性。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,采用高效液相色谱法测定主药的含量,流动相为甲醇-0.4%磷酸(三乙胺调pH至3.0,48∶52),检测波长270 nm;通过正交实验,根据体外释放度筛选优化处方。结果根据最佳处方制备的三清降糖方总苷缓释片质量稳定,体外释放性能好,持续释药12 h,符合《中华人民共和国药典》2010年版要求。结论从体外释放分析,以该优化处方制备的三清降糖方总苷缓释片达到缓释制剂的要求。Objective To optimize the production process of total glycosides sustained-release tablets from sanqing fiangtang decoction and evaluate the drug release property. Methods The hydrophilic matrix hydroxypropyl methylcellulose （HPMC） was used to prepare sustained-release tablets with the wet granule compression technique. The content of the main ingredient was determined by HPLC. The mobile phase consisted of methanol-0.4% phosphoric acid（48 ： 52 ,adjusted to pI-I 3.0 with triethylamine）and detection was carried out at 270 nm wavelength. The tablets processing was optimized with orthogonal test in line with in vitro release. Results The optimized formulation releaseds drug continuously over 12 h in vitro, which complied with the requirement of the Chinese Pharmacopoeia （2010）. Conclusion The total glycosides sustained release tablets prepared as the optimized prescription reaches meets the requirement for sustained release prescription regarding the in vitro release.

关 键 词：三清降糖方 缓释片 正交实验 释放度 体外 

分 类 号：R286[医药卫生—中药学] TQ460.6[医药卫生—中医学]