目的 以NE30D為膜控材料,考察其對(duì)鹽酸氨溴索滲透作用的影響,探索制定鹽酸氨溴索的緩釋特征參數(shù).方法 以不同濃度的NE30D制備成膜作為滲透阻滯材料,以三室滲透裝置考察NE30D膜厚度、鹽酸氨溴索溶液濃度、同一批號(hào)膜材料批內(nèi)和批間多個(gè)樣本對(duì)透過(guò)率的影響,并計(jì)算阻滯效率.結(jié)果 同一批號(hào)膜材料批內(nèi)和批間制備的不同樣本,通過(guò)控制制備參數(shù)得到的NE30D膜對(duì)鹽酸氨溴索的阻滯效率重現(xiàn)性非常好,5%濃度制備的膜的阻滯效率在4.0%～4.6%/h,10%濃度制備的膜的阻滯效率在9.0%～9.4%/h.結(jié)論 5%和10%濃度制備的NE30D膜對(duì)鹽酸氨溴索的阻滯效率影響非常大,表明鹽酸氨溴索可以通過(guò)改變膜的厚度來(lái)實(shí)現(xiàn)適當(dāng)?shù)尼尫潘俣?也表明NE30D是比較理想的鹽酸氨溴索的緩釋膜控材料.提示NE30D對(duì)于鹽酸氨溴索的膜控緩釋特征參數(shù)可以采用高、低濃度制備膜的阻滯效率及其差值.

Objective To explore the infiltration of ambroxol hydrochloride and the development of sustained-release characteristic parameters with NE30D used as film control materials. Methods The NE30D at different concentration was used as membrane permeable block material to investigate the effect of NE30D 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 NE30D 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 NE30D is a kind of ideal controlled-release film material to ambroxol hydrochloride.