硝苯地平缓释片中间产品颗粒粒度的分布研究及对溶出度的影响  

Particle Size Distribution Study of Nifedipine Prolonged-release Tablets Intermediate Products and its Effect on Dissolution

作　　者：肖艳 高永坚 梁标志 梁思韵 区淑蕴 XIAO Yan;GAO Yong-jian;LIANG Biao-zhi;LIANG Shi-yun;OU Shu-yun(Sinopharm Group Guangdong Medi-World Pharmaceutical Co.,Ltd.,Foshan 528303,China)

机构地区：[1]国药集团广东环球制药有限公司,广东佛山528300

出　　处：《海峡药学》2024年第5期38-43,共6页Strait Pharmaceutical Journal

摘　　要：目的建立激光衍射法测定硝苯地平缓释片中间产品颗粒的粒度及分布,探讨颗粒粒度分布对药物制剂体外溶出的影响。方法欧美克LS-909激光粒度仪,DPF-110干法进样器;背景测量时间15s,样品测量时间15s;遮光率范围为0.50%~5.00%,样品折射率为1.584,颗粒吸收率为0.01;材质密度为1.271 g/cm^(3),分散压为150 kpa,进样速度为40%,进样口宽度为6 mm,样品量为3.0 g。结果激光衍射法可准确测定硝苯地平缓释片中间体颗粒的粒度分布,方法精密度和样品测定值RSD值均符合要求;4批自制样品粒径分布值d 0.5分别为321.458、398.026、417.958、669.346μm,且颗粒粒度越大,制成的制剂的溶出速度越慢。结论本方法适用于硝苯地平缓释片中间体颗粒粒径分布的测定,且颗粒的粒度分布对溶出有显著的影响,在药物制剂生产过程中进行粒度控制至关重要。OBJECTIVE To establish a laser diffractometry for determination of the particle size and distribution of nifedipine sustained-release tablet intermediates,and to explore the effect of particle size distribution on the in vitro dissolution of pharmaceutical formulations.METHODS OMEC LS-909 laser particle size analyzer with DPF-110 dry feeder was used.The determination conditions were as follows:measurement time for background of 15s,measurement time for sample of 15s;laser obscuration of 0.50%-5.00%,sample refractive index of 1.584,particle absorbance of 0.01;material density of 1.271 g/cm^(3),dispersion pressure of 150 kpa,feed speed of 40%,inlet width of 6 mm,and sample volume of 3.0 g.RESULTS The laser diffractometry can accurately determine the particle size distribution of nifedipine sustained-release tablet intermediates,and the precision of the method and the RSD value of the sample meet the requirements;The particle size distribution values d 0.5 of 4 batches of self-made samples were 321.458μm,398.026μm,417.958μm and 669.346μm,respectively.What′s more,the larger the particle size,the slower the dissolution rate of the preparation made.CONCLUSION This method is applicable to the particle size and its distribution determination of nifedipine sustained-release tablet intermediates.And the particle size distribution of particles has a significant effect on dissolution.Therefore,it is essential to carry out particle size control in the production process of pharmaceutical formulations.

关 键 词：硝苯地平 粒度分布 干法测定 溶出度 

分 类 号：R927[医药卫生—药学]