A intermediate station: the intermediate station shall be set for all kinds of raw and auxiliary materials from the warehouse to prevent errors and be responsible for the collection, storage and distribution of raw and auxiliary materials.
B. pretreatment of raw and auxiliary materials: raw and auxiliary materials need to be screened or crushed before use to reach the specified fineness.
C ingredients: calculate, weigh and feed according to the prescription, store the prepared materials in the container, and then return them to the intermediate station.
D granulation: the material after mixing evenly is gradually added with adhesive or wetting agent to prepare soft material, and then it is formed into particles through particle mechanism.
E drying: dry the wet particles in the drying oven or through the boiling drying bed dryer.
F whole particle: dry the particles through the whole granulator, turn on the dust collector during the whole particle, and mix them through the v-mixer after the whole particle.
G tablet pressing: the particles are pressed through the tablet press.
H coating: the plain tablets are coated in the coating machine by dissolving the syrup boiled and filtered with pure water.
I subpackage: the tablets are subpackaged or packed by the packaging machine.
2. Area division: ① general production area: refers to the production workshop and auxiliary workshop without cleanliness requirements. ② Control area: production workshop and auxiliary workshop with certain requirements for cleanliness or colony number. ③ Clean area: production workshop with higher cleanliness or colony number requirements. Relative negative pressure shall be maintained between the whole granule, tablet pressing, coating and the outer room, and dust device shall be removed locally.
Production process of tablet
1. Wet granulation: ① formulation of operation procedures: Specification and dosage of main drug, auxiliary materials and dosage, detailed method and machinery for preparing particles, drying temperature, specification of tablet pressing punch, weight of finished product, color, appearance, hardness, disintegration time limit, dissolution, etc. ② Raw material preparation and treatment: raw and auxiliary materials must be identified, determined, dried, crushed and screened before being put into production; the fineness of raw and auxiliary materials powder is generally about 80-100 mesh or finer. 3. Weighing and mixing: weigh the raw and auxiliary materials respectively according to the prescription amount. Due to the different proportion of powder color and fineness, sieve them for 1-2 times with the coarser size, mix them preliminarily, and then sieve them with the finer size to make them fully mixed. For highly toxic drugs or trace elements, 120-150 mesh of fine powder shall be taken, mixed with some auxiliary materials or dissolved in a suitable solvent and absorbed with a small amount of auxiliary materials, and then add them in the same amount Mix, and then sieve once with 100 mesh sieve, and then sieve 1-3 times with 80-100 mesh sieve to fully mix. ④ Granulation
Treatment of dry particles before tablet pressing: ① 12 mesh-20 mesh whole particles are generally used ② Add volatile oil and volatile drugs: it's better to add them into the part of fine powder sifted out after lubricant and particles are well mixed, and then mix them with all dry particles to avoid uneven mixing of lubricant and mottling; it can also use 80 mesh sieve to sift out a proper amount of fine powder from particles, absorb volatile oil and then mix them in dry particles, if the added volatile substances are solid, dissolve them with ethanol first, or mix them with dry particles Other components are mixed, grinded and melted together, sprayed on the particles and mixed evenly, and stored in the bucket for several hours to make them penetrate evenly in the particles, otherwise, cracks will be produced due to the absorption of volatile oil on the particle surface during tablet pressing. ③ Add lubricant and disintegrating agent: generally, the lubricant is sieved by fine screen, usually added when sieving the whole particle; the disintegrating agent is dried and sieved first, then slowly added into the dry particle and fully mixed, moved into the container and sealed, and pressed after passing the sampling inspection.