摘要
目的:制备栓塞控制型尼群地平脉冲胶囊,优化制备工艺及处方,考察其体外释药特性。方法:灌注法制备非渗透性胶囊,湿法制粒制备栓塞片及速释片,依次将羧甲基淀粉钠、速释片、栓塞片装于非渗透性胶囊中制得脉冲胶囊,用释放度测定法考察影响释药时滞的各种因素。结果:11%乙基纤维素溶液所制囊身能达到所需非渗透性,含8%低黏度羟丙甲纤维素所制栓塞片能导致适宜的时滞,脉冲胶囊体外释药时滞为(6.5±0.5)h。结论:调节栓塞片处方可获得适当时滞的尼群地平脉冲胶囊,以满足高血压患者的需求。
Objective： To study the formula and preparation process of nitrendipine pulsatile capsules controlled by erodible plugs. Method： The impermeable capsule bodies were prepared by filling method, the plug tablets and erodible plugs were prepared by wet granulation. The pulsatile capsules were prepared by putting the rapid disintegrating tablets into the impermeable body and sealing with the erodible plug tablets. The influencing factors of the lag time were investigated by the drug release determination. Result： The cap- sule bodies prepared with 11% ethyl cellulose（ EC ） solution could keep impermeable in need. The erodible plug tablets prepared with 8 % hypromellose cellulose （HPMC, low viscosity） could obtain the appropriate lag time. The lag time of nitrendipine pulsatile cap-sules controlled by erodible plugs was （6.5 ±0.5 ）h. Conclusion： The pulsatile capsules with suitable lag time can be achieved by adjusting the formula of the plug tablets, which meet the needs of the patients with hypertension.
出处
《中国药师》
CAS
2013年第4期509-511,共3页
China Pharmacist
关键词
尼群地平
栓塞片
脉冲胶囊
Nitrendipine
Erodible plugs
Pulsatile capsules
