NE30D作为膜控材料的盐酸氨溴索缓释特征参数的研究  

Research of sustained-release characteristic parameters that ambroxol hydrochloride by NE30D as film control materials

作　　者：吴国顺[1,2] 孟策[2] 李均艳 方玉[2,3] 任晓文[2] 

机构地区：[1]天津中医药大学,天津300193 [2]天津药物研究院释药技术与药代动力学国家重点实验室,天津300193 [3]河南大学药学院,河南开封475001

出　　处：《药物评价研究》2015年第1期56-60,共5页Drug Evaluation Research

摘　　要：目的以NE30D为膜控材料,考察其对盐酸氨溴索渗透作用的影响,探索制定盐酸氨溴索的缓释特征参数。方法以不同浓度的NE30D制备成膜作为渗透阻滞材料,以三室渗透装置考察NE30D膜厚度、盐酸氨溴索溶液浓度、同一批号膜材料批内和批间多个样本对透过率的影响,并计算阻滞效率。结果同一批号膜材料批内和批间制备的不同样本,通过控制制备参数得到的NE30D膜对盐酸氨溴索的阻滞效率重现性非常好,5%浓度制备的膜的阻滞效率在4.0%~4.6%/h,10%浓度制备的膜的阻滞效率在9.0%~9.4%/h。结论 5%和10%浓度制备的NE30D膜对盐酸氨溴索的阻滞效率影响非常大,表明盐酸氨溴索可以通过改变膜的厚度来实现适当的释放速度,也表明NE30D是比较理想的盐酸氨溴索的缓释膜控材料。提示NE30D对于盐酸氨溴索的膜控缓释特征参数可以采用高、低浓度制备膜的阻滞效率及其差值。Objective To explore the infiltration of ambroxol hydrochloride and the development of sustained-release characteristic parameters with NE30 D used as film control materials. Methods The NE30 D at different concentration was used as membrane permeable block material to investigate the effect of NE30 D film thickness, different concentration of ambroxol hydrochloride solution, the membrane material batch multiple samples and inter-assay samples on transmittance by penetrating three bedroom unit and to calculate the retarding effect. Results The blocking efficiency to ambroxol hydrochloride of NE30 D film prepared by the different preparation control parameter had very good reproducibility and blocking efficiency of the membrane prepared at a concentration of 5% was 4.0—4.6%, at the same time, blocking efficiency of the membrane prepared at a concentration of 10% was 9.0—9.4%. Conclusion The effect of membrane at the concentration of 5% is proper, but the concentration of 10%, is very large to the blocking efficiency of ambroxol hydrochloride. It indicates that not noly ambroxol hydrochloride can be achieved proper release rate by changing the thickness of films, but also that NE30 D is a kind of ideal controlled-release film material to ambroxol hydrochloride.

关 键 词：膜控缓释 NE30D 盐酸氨溴索 标准化参数 

分 类 号：R943.4[医药卫生—药剂学]