摘要
目的制备藤甲酰苷双层片,优化其处方及制备工艺并探讨其药物释放机制。方法用水溶性载体材料聚乙二醇制备固体分散体,制成藤甲酰苷速释层,选择羟丙基甲基纤维素(HPMC)作为主要的缓释材料,制成藤甲酰苷缓释片层,通过单因素考察确定了藤甲酰苷双层片缓释层的处方。使用DDslover软件拟合缓释层释放曲线。结果本方法制备的藤甲酰苷双层片符合体外释放度要求。其中缓释层的体外释药行为符合Higuchi模型,相关系数r=0.998 3,释放机制为扩散和骨架溶蚀协同作用。结论本方法制备的藤甲酰苷双层片达到既快速起效,又缓释长效的目的。
OBJECTIVE To optimize the prescription and preparation process of garcinia glycoside bilayer tablets and study the drug release mechanism in vitro. METHODS Solid dispersions were prepared by using water soluble carrier material polyethylene glycol （PEG） and then used to prepare the rapid release layer. Hydroxypropylmethyl cellulose （HPMC） was used as main sustained release material to prepare the sustained release layer. The formulations of rapid release layer and sustained release layer were opti- mized by using univariate analyses. DDslover software was used to fitting drug release curve. RESULTS The content of the garcinia glycoside in the bilayer tablets was 98.5% and its release rate was consistent with the rule of release in vitro. The release behavior of the sustained release layer in vitro followed Higuchi equation （ r = 0. 998 3 ）. The main mechanism of drug release was the synergistic action of diffusion and dissolution. CONCLUSION Garcinia glycoside bilayer tablets prepared by this method can achieve the goal of both rapid-acting and long-acting.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2016年第9期723-726,共4页
Chinese Pharmaceutical Journal
基金
国家“十一五”规划“重大新药创制”重大科技专项资助项目(2009ZX09103-030)
关键词
藤甲酰苷
双层片
固体分散体
释放机制
garcinia glycoside
bilayer tablet
solid dispersion
release mechanism
