本文選題：西尼地平　切入點(diǎn)：緩釋片　出處：《中國(guó)藥房》2017年25期

【摘要】：目的:優(yōu)化西尼地平緩釋片處方,研究其釋藥機(jī)制。方法:采用溶劑法制備西尼地平固體分散體,再以羥丙甲纖維素K4M(HPMC K4M)為緩釋材料制備西尼地平緩釋片。利用單因素法和Box-Behnken響應(yīng)面法,以2、6、12 h累積釋放度的綜合評(píng)分為指標(biāo),篩選西尼地平緩釋片處方中HPMC K4M用量、乙基纖維素(EC)用量、乳糖-微晶纖維素(MCC)比例,并進(jìn)行驗(yàn)證。通過(guò)模型擬合的方式考察西尼地平緩釋片的釋藥機(jī)制。結(jié)果:最優(yōu)處方為西尼地平固體分散體25%、HPMC K4M 30%、EC 10%、乳糖-MCC(1∶1,m/m),黏合劑為5%的聚乙烯吡咯烷酮乙醇溶液,潤(rùn)滑劑為0.5%的硬脂酸鎂。所制緩釋片2、6、12 h時(shí)的累積釋放度分別為(21.4±3.3)%、(62.9±2.8)%、(85.4±0.5)%(n=3),與預(yù)期值25%、60%、90%的相對(duì)誤差分別為14.4%、4.8%、5.1%;釋放曲線與一級(jí)釋藥模型擬合度最高,符合non-Fick擴(kuò)散機(jī)制。結(jié)論:按優(yōu)化后的處方成功制得具有緩釋作用的西尼地平緩釋片。
[Abstract]:Objective: to optimize the formulation of cinedipine sustained-release tablets and study the mechanism of its release. Methods: the solid dispersions of cilnidipine were prepared by solvent method. Cinedipine sustained release tablets were prepared by using hydroxypropylcellulose K4M(HPMC K4M as the sustained-release material. The dosage of HPMC K4M in the formulation of Xenodipine sustained-release tablets was screened by single factor method and Box-Behnken response surface method. The ratio of lactose to microcrystalline cellulose (MCCs), the amount of ethyl cellulose (EC), The drug release mechanism of the sustained-release tablets was investigated by model fitting. Results: the optimal formulation was 25 HPMC K4M30 and EC 10, lactose-MCC1: 1: 1 m / m ~ (-1), and the adhesive was 5% polyvinylpyrrolidone ethanol solution. The cumulative release rate of the sustained-release tablets was 21.4 鹵3.3% at 12 h, respectively. The cumulative release rate of the sustained-release tablets was 62.9 鹵2.8% and 85.4 鹵0.5%, respectively, and the relative error from the expected value of 254,60,90% was 14.44.85.1.The release curve fitted best with the first-order release model. Conclusion: cilnidipine sustained-release tablets with sustained release were successfully prepared according to the optimized formulation.
【作者單位】： 山東大學(xué)第二醫(yī)院門診藥房;
【分類號(hào)】：R943

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本文編號(hào)：1661647