Production technology of granules and tablets.

Wet granulation and tabletting method is a method of drying and tabletting wet granulation particles.

(1) Treatment of raw materials and auxiliary materials

Generally, the main medicine and auxiliary materials need to be crushed, sieved and dried before mixing. Raw and auxiliary materials that are easy to get wet and agglomerate must be dried before crushing and sieving. The fineness should pass the 80 ~ 100 mesh sieve, and toxic drugs, precious drugs and colored raw materials should be finer, so as to mix evenly and accurately, and avoid the phenomenon of separation, adhesion and spots.

(2) granulating

Wet granulation is the process of processing powder, slurry or solvent into particles with a certain shape and size. It mainly includes the steps of making soft materials, making wet particles, drying wet particles, grading and so on.

1. Making cork

Put the fine powder into a blender, add a proper amount of wetting agent or adhesive, stir and mix evenly, and make a soft material.

Methods: Manual stirring can be used for small-scale production and mixer can be used for large-scale production. The degree of dryness and wetness of cork should be appropriate, and it should be mastered by experience in production, with the degree of "holding into a ball and pressing away" by hand.

When making soft materials, attention should be paid to:

(1) raw and auxiliary materials should be crushed and screened with 80 ~ 100 mesh;

(2) When the proportion of the main drug and the auxiliary materials is quite different, the equal amount recursive method or solvent dispersion method should be adopted for mixing;

③ The dosage of adhesive, preparation time and stirring intensity should be properly controlled. The amount of binder and mixing conditions have certain influence on the density and hardness of the prepared particles. Generally, when a large amount of binder is used, the prepared particles have higher hardness, higher mixing strength and longer time. The dosage of wetting agent or adhesive should be determined according to the nature of the material, such as fine powder, loose texture, dry powder and poor viscosity, which should be increased as appropriate, otherwise the dosage should be reduced as appropriate.

2. Wet granulation

Squeeze the soft material through a suitable sieve to form particles.

Note: If the soft material is not granular but long when it falls from the sieve hole, it means that the soft material is too wet and the amount of adhesive or wetting agent is too much; On the contrary, if the soft material is powdery after passing through the sieve hole, it means that the soft material is too dry, and the dosage of adhesive or wetting agent should be adjusted appropriately.

In mass production, there are many kinds of wet granulation equipment:

(1) Extrusion granulation method and equipment.

(2) Rotary granulation method and equipment.

(3) Fluidized bed granulation method and equipment.

(4) Spray granulation method and equipment.