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目的:制备具有胃内漂浮和生物黏附特征的油酸胃滞留微丸,并考察处方中各因素对其体外释药的影响。方法:采用熔融制粒法制备油酸胃滞留微丸,分别将各因素不同处方在1、3、5、6 h的累积释放度作为取样点,计算释药百分率,并以f2相似因子对各因素进行相似性判断,以考察不同因素对释药行为的影响。结果:所制备的胃滞留微丸具有良好的缓释作用和漂浮能力,6 h体外累积释放度能达到90%以上。结论:处方中HPMC与Na HCO3的比例,Cp与Lactose的比例,compritol在辅料中的用量对于药物的释放均有较大影响,而且各个因素不同处方之间的差异也比较大。
OBJECTIVE: To prepare oleic acid gastric retention pellets with gastric floating and bioadhesive characteristics and investigate the influence of various factors on the in vitro release. Methods: Oleic acid gastric retentate pellets were prepared by melt granulation method. The cumulative release rates of different prescriptions at 1, 3, 5 and 6 h were used as sampling points to calculate the percentage of drug release. The f2 similarity factor Factors to determine the similarity, in order to investigate the different factors on drug release behavior. Results: The prepared gastroretentive pellets had good sustained release and floating ability, and the cumulative release in vitro reached more than 90% at 6 h. CONCLUSION: The ratio of HPMC to Na HCO3, the ratio of Cp to Lactose and the amount of compritol in the excipients have a significant impact on the drug release, and the differences between the different prescriptions of each factor are also relatively large.