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胶囊半自动充填机采用电器、气动控制及配有电子计数装置、电脑调速装置等,能分别完成胶囊的就位、分离、充填、锁紧等工序能提高生产效率、充填剂量准确。现就使用中,药物原料与辅料的质量要求,影响装量差异的因素及常见问题的处理方法作一讨论。1 填充料的质量要求及装量差异的控制 胶囊半自动充填机采用螺旋加压灌装方式,对填充料的流动性适应范围较宽,流动性好的药物可以直接充填。流动性差的药物通过制粒改善其流动性方可充填。1.1 填充料在充填操作时,粉末的流动性对胶囊剂装量差异的影响很大。由于药物粒子间存在着范德华力,静电力及粒子表面的摩擦力,造成了药粉外表的吸附与凝集。有些药物具有松散感,表观体积小,不易飞扬,吸附性小,粘性也小,可直接用药粉装填,如诺氟沙星、阿莫西林、肌苷等都可直接装填,其装量差异均在允许范围内。而有些药物有潮湿感,表观体积大,易飞扬,吸附性大,粘性也大、直接装填很困难、往往需要制成颗粒,才能使装量差异符合药典要求。如头孢氨苄、头孢拉定、环丙沙星、氧氟沙星、萘普生等。充填前可用简单的方法测定休止角,根据经验,休止角小于40°时可直接充填,经过试装检查装量差异合格后方可进行正式装填。
Capsule semi-automatic filling machine with electrical, pneumatic control and equipped with electronic counting device, computer speed control device, can complete the capsule in place, separation, filling, locking and other processes can increase production efficiency, filling dose accurately. Now on the use of the quality requirements of raw materials and excipients, the factors that affect the load difference and common problems to make a discussion. 1 filler quality control requirements and loading differences Capsule semi-automatic filling machine using spiral pressure filling method, the fluidity of the filler to adapt to a wide range, good liquidity of the drug can be directly filled. Poorly liquid drugs can be filled by granulating to improve their fluidity. 1.1 Filling material In the filling operation, the fluidity of the powder capsule dosage greatly affected. Due to the presence of van der Waals forces, electrostatic forces and particle surface friction between the drug particles, resulting in the appearance of powder adsorption and agglutination. Some drugs have loose feeling, apparent volume is small, easy to fly, small adsorption, viscosity is also small, can be directly filled with powder, such as norfloxacin, amoxicillin, inosine and so on can be directly loaded, the loading capacity difference Are within the allowable range. Some drugs have dampness, apparent volume, easy to fly, large adsorption, viscosity is also large, direct loading is difficult, often need to be made of particles, in order to make the difference in loading capacity in line with Pharmacopoeia requirements. Such as cephalexin, cephradine, ciprofloxacin, ofloxacin, naproxen and so on. Before filling, the angle of repose can be measured by a simple method. According to experience, the angle of repose can be directly filled when the angle of repose is less than 40 °.