Empty capsule preparation process: The empty capsule is composed of a capsule and a capsule, and the main preparation process is as follows:
Sol, silicone (casting), drying, shelling, cutting, finishing, generally completed by automated production line, production environment cleanliness should reach 100,000, temperature 10-25 ° C, relative humidity 35% -45%. For easy identification The empty capsule shell can also be printed with edible ink.
The specifications and quality of empty capsules: The quality and specifications of empty capsules are clearly defined. There are 8 kinds of specifications for empty capsules, but the commonly used ones are 0~5. As the number is from small to large, the volume is from large to small.
Preparation, filling and sealing of filling materials.
If the pure drug is pulverized to a suitable particle size to meet the filling requirements of the hard capsule, it can be directly filled, but most of the drugs need to be added with certain diluents, lubricants and other auxiliary materials due to poor fluidity, etc. Requirements for medication). Generally, sucrose, lactose, microcrystalline cellulose, modified starch, silica, magnesium stearate, talc, HPC, etc. can be added to improve boring mobility or avoid delamination. It is also possible to add an auxiliary material to form a granule and then fill it.
Selection and fitting of capsule specifications, sealing: The specification of empty capsule should be selected according to the filling amount of the medicine. Firstly, the minimum empty capsule should be selected according to the volume occupied by the prescribed dosage of the medicine, which can be determined according to the experience after trial installation, but the commonly used method is First determine the bulk density of the material to be filled, and then calculate the volume of the material according to the dose to determine the number of capsules to be selected. After filling the capsule with the capsule, the capsule cap can be fitted. At present, the use of lock-type capsules, good airtightness, no need to seal; use non-locking capsules (flat mouth fit) when sealing, sealing materials commonly used different concentrations of gelatin liquid, such as 20% of gelatin, water 40%, ethanol 40% of the mixture, etc.