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盐酸环苯扎林缓释微丸的制备及体外释放度考察
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| 篇名： | 盐酸环苯扎林缓释微丸的制备及体外释放度考察 |
| TITLE： | |
| 摘要： | 目的：制备盐酸环苯扎林缓释微丸，并考察其体外释放度。方法：采用流化床底喷上药技术制备盐酸环苯扎林载药微丸，再以Surelease®水分散体作为缓释包衣剂制成盐酸环苯扎林缓释微丸。以包衣时间、包衣效率和微丸粘连率为因变量，通过Box-Behnken响应面法优化包衣工艺中的进风温度、雾化压力、供液速度。利用f2相似因子法对自制制剂和市售制剂（AMRIX®）在不同介质（水、pH 1.2盐酸水溶液和pH 4.5醋酸盐缓冲液、6.8磷酸盐缓冲液）中的体外释放度进行比较。结果：缓释包衣工艺中包衣增质量为7％，进风温度为55 ℃，雾化压力为0.36 MPa，供液速度为12.5 ml/min；包衣时间为（47.1±2.1）min，包衣效率为（88.4±1.6）％，微丸粘连率为（2.7±0.3）％，与其相应预测值（44.5 min、90.0％、2.9％）的相对误差分别为5.8％、1.8％、6.9％；在4种介质中自制制剂与市售制剂的f2分别为77.7、85.9、83.5、84.6。结论：制得体外释放较好的盐酸环苯扎林缓释微丸。 |
| ABSTRACT： | OBJECTIVE： To prepare cyclobenzaprine hydrochloride extended-release pellets， and to investigate its release rate in vitro. METHODS： The core pellets were prepared by fluid bed coating technology， and sustained-release pellets were prepared using Surelease® aqueous dispersion as sustained-release coating film material. Box-Behnken response surface methodology was used to optimize inlet air temperature， atomization pressure and liquid feed rate using coating time， coating efficiency and pellets adhesion rate as dependent variables. The release rate of prepared pellets and commercially available pellets （AMRIX®） in different mediums （water， pH 1.2 hydrochloric acid solution， pH 4.5 acetate buffer solution， 6.8 phosphate buffer solution） were compared by f2 similarity factor. RESULTS： The weight gain of coating material was 7％； inlet air temperature was 55 ℃； atomization pressure was 0.36 MPa； liquid feed rate was 12.5 ml/min. The relative error of coating time [（47.1±2.1） min]， coating efficiency [（88.4±1.6）％] and pellets adhesion rate [（2.7±0.3）％] to corresponding predicted value （44.5 min，90.0％，2.9％） were 5.8％， 1.8％， 6.9％， respectively. The f2 for prepared pellets and commercially available pellets in 4 kinds of medium were 77.7， 85.9， 83.5， 84.6， respectively. CONCLUSIONS： Cyclobenzaprine hydrochloride sustained-release pellets have been prepared， and have good drug release in vitro. |
| 期刊： | 2016年第27卷第34期 |
| 作者： | 于佳 |
| AUTHORS： | YU Jia |
| 关键字： | 盐酸环苯扎林；缓释微丸；体外释放度；Box-Behnken响应面法；包衣工艺；优化 |
| KEYWORDS： | Cyclobenzaprine hydrochloride； Sustained-release pellets； Release rate in vitro； Box-Behnken response surface methodology； Coating technology； Optimization |
| 阅读数： | 364 次 |
| 本月下载数： | 2 次 |
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