發(fā)布時間：2018-09-13 07:21

【摘要】：目的:制備鹽酸環(huán)苯扎林緩釋微丸,并考察其體外釋放度。方法:采用流化床底噴上藥技術(shù)制備鹽酸環(huán)苯扎林載藥微丸,再以Surelease~?水分散體作為緩釋包衣劑制成鹽酸環(huán)苯扎林緩釋微丸。以包衣時間、包衣效率和微丸粘連率為因變量,通過Box-Behnken響應(yīng)面法優(yōu)化包衣工藝中的進(jìn)風(fēng)溫度、霧化壓力、供液速度。利用f2相似因子法對自制制劑和市售制劑(AMRIX~?)在不同介質(zhì)(水、p H 1.2鹽酸水溶液和p H 4.5醋酸鹽緩沖液、6.8磷酸鹽緩沖液)中的體外釋放度進(jìn)行比較。結(jié)果:緩釋包衣工藝中包衣增質(zhì)量為7%,進(jìn)風(fēng)溫度為55℃,霧化壓力為0.36 MPa,供液速度為12.5 ml/min;包衣時間為(47.1±2.1)min,包衣效率為(88.4±1.6)%,微丸粘連率為(2.7±0.3)%,與其相應(yīng)預(yù)測值(44.5 min、90.0%、2.9%)的相對誤差分別為5.8%、1.8%、6.9%;在4種介質(zhì)中自制制劑與市售制劑的f2分別為77.7、85.9、83.5、84.6。結(jié)論:制得體外釋放較好的鹽酸環(huán)苯扎林緩釋微丸。
[Abstract]:Aim: to prepare cyclbenzalin hydrochloride sustained-release pellets and investigate their release in vitro. Methods: cyclobenzalin hydrochloride pellets were prepared by fluidized bed spray technique, and then Surelease~? was used to prepare the pellets. Water dispersions were used as sustained-release coating agent to prepare cyclobenzalin hydrochloride sustained-release pellets. Based on the dependent variables of coating time, coating efficiency and pellet adhesion rate, the inlet air temperature, atomization pressure and liquid supply rate of coating process were optimized by Box-Behnken response surface method. Using f2 similarity factor method to determine the properties of self-made and marketed preparations (AMRIX~?) The in vitro release rates were compared in different media (aqueous solution of H 1.2 hydrochloric acid and pH 4.5 acetate buffer of 6. 8 phosphate buffer). Results: in the process of slow release coating, the mass increase of coating was 7, and the inlet air temperature was 55 鈩，

本文編號：2240466