基于渗透压原理的丹酚酸B控释胶囊的制备及释放机制研究  

Preparation and release mechanism of salvianolic acid B controlled-release capsules based on osmotic pressure

作　　者：王立[1] 李沐谣 孙斯桐 张文君[1] 吕江唯 崔闻宇[1] WANG Li;LI Mu-yao;SUN Si-tong;ZHANG Wen-jun;LYU Jiang-wei;CUI Wen-yu(School of Pharmacy,Harbin University of Commerce,Harbin 150076)

机构地区：[1]哈尔滨商业大学药学院,哈尔滨150076

出　　处：《中南药学》2021年第2期198-202,共5页Central South Pharmacy

基　　金：哈尔滨商业大学博士科研启动项目资助(No.14LG03);哈尔滨商业大学校级科研项目(No.17XN029)。

摘　　要：目的基于渗透压原理制备丹酚酸B控释胶囊,并对胶囊壳和内容物的处方进行优化和释药机制考察。方法采用蘸胶法制备胶囊,通过单因素考察法,以药物在体外的累积释放度和与零级方程的拟合度作为评价指标,确定丹酚酸B控释胶囊的最佳胶囊壳和内容物的处方。结果最终确定醋酸纤维素(CA)浓度为7%,致孔剂(PEG2000)用量为10 mg,渗透压活性物质(NaCl)用量为30 mg,增塑剂(TEC)用量为20%,阻滞剂(CMC-Na)用量为2 mg。结论本试验成功制备了丹酚酸B控释胶囊,其在12 h内制剂中药物释放完全(累积释放度>90%),且接近零级释放规律,控释效果较好,符合预期。Objective To prepare salvianolic acid B controlled-release capsules based on the principle of osmotic pressure and optimize the prescription of the capsule shells and contents,and determine the drug release mechanism.Methods The osmotic pump capsule shells were prepared by dipping glue method.Through the single factor,the accumulative releasing degree of the drug in vitro and the fitting degree with the zero order equation were used as evaluation indicators to determine the optimal capsule shell and content formulation of salvianolic acid B controlled-release capsules.Results The final CA concentration was 7%,the amount of porogen(PEG2000)was 10 mg,the amount of osmotic active substance(NaCl)was 30 mg,the amount of plasticizer(TEC)was 20%,and the amount of blocker(CMC-Na)was 2 mg.Conclusion The prepared salvianolic acid B controlled-release capsules have a complete release within 12 h(cumulative release>90%),close to the zero-order release rule.

关 键 词：丹酚酸B 控释 释放机制 稳定性 

分 类 号：R286[医药卫生—中药学]