汉防己甲素自微乳化渗透泵片的制备与评价  

Preparation and evaluation of Tetrandrine Self-microemulsifying Osmotic Pump Tablets

作　　者：刘媛媛[1] 贺朝[2] LIU Yuanyuan;HE Chao(Xianyang Vocational College,Xianyang 712000,China;The Second Affiliated Hospital of Shaanxi Traditional Chinese Medicine University,Xianyang 712000,China)

机构地区：[1]咸阳职业技术学院,咸阳712000 [2]陕西中医药大学第二附属医院,咸阳712000

出　　处：《西北药学杂志》2021年第2期249-254,共6页Northwest Pharmaceutical Journal

基　　金：陕西省自然科学基础研究计划项目(编号:2019JQ-871)。

摘　　要：目的制备汉防己甲素自微乳化释药系统,并进一步制备成渗透泵片,考察其体外释放。方法根据测定汉防己甲素在不同种类油相、表面活性剂和助表面活性剂中的溶解度确定汉防己甲素自微乳化释药系统的处方构成,并通过绘制伪三元相图确定其处方中各辅料用量范围,进一步将汉防己甲素自微乳化释药系统固化并制备成渗透泵片,并以氯化钠用量(X_(1))、致孔剂用量占包衣液固体含量的百分比(X_(2))以及包衣增质量百分比(X_(3))作为变量因素,以药物分别在2、6、10 h的释放量作为评价指标,使用中心复合设计-效应面法优化汉防己甲素自微乳化渗透泵片处方,并考察其体外药物释放特性。结果实验优化得到汉防己甲素自微乳化渗透泵片的最优处方为:氯化钠用量为120 mg,致孔剂用量占包衣液固体含量的百分比为100%,包衣增质量百分比为3%,制备的汉防己甲素自微乳化渗透泵片释药平稳且完全。结论将汉防己甲素制备成自微乳化渗透泵片,处方设计合理,工艺稳定,药物释放符合质量标准要求。Objective To prepare Tetrandrine Self-microemulsifying Osmotic Pump Tablets and investigate the dissolution in vitro.Methods According to the solubility of tetrandrine in different oil phases,surfactants and co-surfactants,the formulation composition of tetrandrine self-microemulsifying drug delivery systems were determined,and the pseudo-ternary phase diagram was drawn to determine the amount of excipients.The tetrandrine self-microemulsifying drug delivery systems were solidified and prepared into an osmotic pump tablet.By taking the NaCl amount(X_(1)),the percentage of porogen for solid content in the coating solution(X_(2))and the percentage of coating weight(X_(3))as the variables,and the dissolution of 2,6 and 10 h as evaluation index,the central composite design-response surface methodology was used to optimize the formulation of Tetrandrine Self-microemulsifying Osmotic Pump Tablets.The in vitro dissolution characteristics of Tetrandrine Self-microemulsifying Osmotic Pump Tablets were investigated.Results The optimal formulation of Tetrandrine Self-microemulsifying Osmotic Pump Tablets was obtained:the NaCl amount 120 mg,the percentage of porogen for solid content in the coating solution 100%,and the percentage of coating weight 3%.The drug release was stable and complete.Conclusion The formulation of Tetrandrine Self-microemulsifying Osmotic Pump Tablets is reasonable,the process is stable,and the dissolution meets the requirements of quality standards.

关 键 词：汉防己甲素 自微乳化释药系统 渗透泵片 中心复合设计-效应面法 释放度 

分 类 号：R94[医药卫生—药剂学]