本文選題：鹽酸地芬尼多 + 雙層滲透泵片　； 參考：《中國(guó)藥房》2017年13期

【摘要】：目的:制備鹽酸地芬尼多雙層滲透泵片并研究其體外釋放特性。方法:采用雙層壓片技術(shù)和薄膜包衣工藝制備鹽酸地芬尼多雙層滲透泵片,比較其與市售鹽酸地芬尼多普通片、自制鹽酸地芬尼多單層滲透泵片的體外釋放度。結(jié)果:鹽酸地芬尼多雙層滲透泵片處方為鹽酸地芬尼多75 mg、氯化鈉10 mg、低分子量聚氧乙烯15 mg、5%聚乙烯吡咯烷酮K30乙醇溶液適量;助推層為高分子量聚氧乙烯60 mg、氯化鈉20 mg、聚乙烯吡咯烷酮K30 6 mg、硬脂酸鎂適量。所制雙層滲透泵片12 h累積釋放度(Q)達(dá)80%,且釋放符合零級(jí)動(dòng)力學(xué)方程;鹽酸地芬尼多普通片的Q15 min達(dá)90%,鹽酸地芬尼多單層滲透泵片的Q12 h僅為51.14%。結(jié)論:所制鹽酸地芬尼多雙層滲透泵片具有緩釋作用,且較單層滲透泵片12 h內(nèi)釋藥更完全。
[Abstract]:Aim: to prepare difenidol hydrochloride double-layer osmotic pump tablets and to study its release characteristics in vitro. Methods: Difenido hydrochloride bilayer osmotic pump tablets were prepared by double layer pressing technique and film coating process. The in vitro release of difenidol hydrochloride osmotic pump tablets was compared with that of ordinary difenidol hydrochloride tablets and difenidol hydrochloride osmotic pump tablets made by ourselves in vitro. Results: Difenido hydrochloride double-layer osmotic pump tablets were formulated as follows: difenido hydrochloride 75 mg sodium chloride 10 mg low molecular weight polyoxyethylene 15 mg 5% polyvinylpyrrolidone K30 alcohol solution. The booster layer consists of high molecular weight polyoxyethylene 60 mg, sodium chloride 20 mg, polyvinylpyrrolidone K306 mg and magnesium stearate proper amount. The cumulative release (Q) of the bilayer osmotic pump was 80 and the release was in accordance with the zero order kinetic equation, the Q15 min of Difenido hydrochloride ordinary tablet was 90 and the Q12 h of Difenido hydrochloride was only 51.14. Conclusion: Difenidol hydrochloride bilayer osmotic pump tablet has a sustained release effect and is more complete than that of single layer osmotic pump tablet in 12 h.
【作者單位】： 南方醫(yī)科大學(xué)藥學(xué)院;廣州軍區(qū)武漢總醫(yī)院藥劑科;湖北中醫(yī)藥大學(xué)藥學(xué)院;
【基金】：國(guó)家“十二五”重大新藥創(chuàng)制科技重大專項(xiàng)經(jīng)費(fèi)資助課題(No.2013ZX09J13109-05C)
【分類號(hào)】：R943

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