氧化苦参碱磷脂复合物缓释肠溶胶囊内容物的物理特性研究

Research on the Physical Characteristics of the Contents of Oxymatrine Phospholipid Complex Enteric-coated Capsule

目的研究氧化苦参碱磷脂复合物缓释肠溶胶囊内容物的物理特性,为优选胶囊内容物的辅料、生产、储存条件提供科学依据。方法采用固定漏斗法测定休止角;采用量筒法测定堆密度与振实密度;采用液体置换法测定真密度;采用卡尔系数表征压缩性;采用粉末吸湿法测定吸湿率与临界相对湿度。结果氧化苦参碱磷脂复合物胶囊内容物的休止角为(31.35±0.23)°,堆密度为(0.22±0.01)g/ml,振实密度为(0.32±0.01)g/ml,压缩性为(32.28±1.04)%,真密度为1.01g/ml,在相对湿度75%时的吸湿率为12.83%,临界相对湿度为72.93%。结论氧化苦参碱磷脂复合物缓释肠溶胶囊内容物具有流动性好、不易吸湿等优点。

Objective To study the physical characteristics of the contents of oxymatrine phospholipid complex enteric-coated capsule, in order to provide a scientific basis for selection optimizing the excipients, production and storage conditions of capsule contents. Methods The angle of repose is measured by fixed funnel method. The bulk density and tap density are measured by cylinder method. The true density is measured by liquid displacement method. Carle coefficients are used to characterize compressibility. The moisture absorption and critical relative humidity（CRH） are measured by powder moisture absorption method.Results According to the experiments of the contents of oxymatrine phospholipid complex enteric-coated capsule, the angle of repose is（31.35 ＋ 0.23） degrees, the bulk density is（0.22 ＋ 0.01） g/ml, the tap density is（0.32 ＋ 0.01） g/ml, the compression is（32.28 ＋ 1.04） %, the true density is 1.01 g/ml, the moisture absorption rate is 12.83 % when the relative humidity is 75 %, and the critical relative humidity is 72.93 %. Conclusion The contents of oxymatrine phospholipid complex enteric-coated capsule has the advantages of good fluidity and poor moisture absorption.