發(fā)布時(shí)間：2018-05-15 12:22

  本文選題：硝苯地平 + 中空控釋微球　； 參考：《中國藥房》2017年13期

【摘要】：目的:制備硝苯地平(NF)中空控釋微球并評價(jià)其質(zhì)量。方法:采用溶劑擴(kuò)散揮發(fā)法制備微球。以2、12、24 h的累積釋放度(Q_(2h)、Q_(12h)、Q_(24h))的綜合評分為指標(biāo),設(shè)計(jì)正交試驗(yàn)篩選處方中載體材料乙基纖維素(EC)、聚乙烯吡咯烷酮(PVP)和主藥NF用量;評價(jià)最優(yōu)處方所制微球的外觀形態(tài)、粒徑分布、載藥量、漂浮性及累積釋放度,并與進(jìn)口制劑NF控釋片(Adalat~?)比較體外釋放行為。結(jié)果:最優(yōu)處方為NF 3.00 g、PVP 1.60 g、EC 15.65 g。所制NF中空控釋微球外觀呈球形,粒徑主要分布于20~40目,載藥量為8.66%;在釋放介質(zhì)中24 h的漂浮率為97.93%;(Q_(2h)、Q_(12h)、Q_(24h))分別為20.49%、52.90%、91.00%(RSD10%,n=3),與進(jìn)口制劑比較,累積釋放度的相似因子(f_2)均大于50;體外釋藥符合零級動(dòng)力學(xué)方程(r=0.999 3),其Ritger-Peppas方程(r=0.980 7)的n為0.478。結(jié)論:所制NF中空控釋微球與進(jìn)口制劑具有相似的釋藥行為,其釋藥機(jī)制為擴(kuò)散和骨架溶蝕共同作用。
[Abstract]:Objective: to prepare nifedipine NFN hollow controlled-release microspheres and evaluate their quality. Methods: the solvent diffusion volatilization method was used to prepare microspheres. Based on the cumulative release rate of 2h / 2h / s / 24h / h, the orthogonal test was designed to screen the dosage of ethyl cellulose, polyvinylpyrrolidone (PVP) and main drug NF in the formulation, and to evaluate the appearance and particle size distribution of the microspheres prepared by the optimal formulation, and to evaluate the distribution of the appearance and particle size of the microspheres prepared by the best prescription. Drug loading, floatability and cumulative release, with imported NF controlled-release tablets. To compare the release behavior in vitro. Results: the best prescription was NF 3.00 g PVP 1.60 g EC 15.65 g. The NF hollow controlled-release microspheres were spherical in appearance, the diameter of which was mainly distributed at 20 ~ 40 mesh, and the drug content was 8.66. The floatation rate was 97.93% in the release medium for 24 h. The floatation rate of the NF hollow controlled-release microspheres was 20.499,52.90,91.00% RSD10nc3H, respectively, compared with the imported preparations. The similar factor of cumulative release was more than 50 (n = 0.478), and the drug release in vitro was in accordance with the zero order kinetic equation (r = 0.999 3) and its Ritger-Peppas equation (r = 0.980 7). Conclusion: NF hollow controlled-release microspheres have similar drug release behavior to imported preparations, and the drug release mechanism is the joint action of diffusion and skeleton dissolution.
【作者單位】： 西南醫(yī)科大學(xué)附屬醫(yī)院研究生部;西南醫(yī)科大學(xué)藥學(xué)院藥劑學(xué)教研室;西南醫(yī)科大學(xué)附屬醫(yī)院心血管內(nèi)科;
【基金】：國家自然科學(xué)基金資助項(xiàng)目(No.81341124) 四川省科技計(jì)劃項(xiàng)目(No.2014FZ0105,14ZC0066)
【分類號】：R943

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