Granulator common equipment and features
Summary:
Starting from the granulation concept, the characteristics of the wet granulation process are expounded. At the same time, from the perspective of process and GMP, the manufacturing requirements and influencing factors of the high-speed mixing granulator are described.
In the production of solid preparation tablets, mixing and granulation are the key to determining the quality of the tablets or capsules. In a sense, granulation is the key basis. However, the purpose of granulation is to solve the problem of component separation and particle size difference in the mixing of drugs and auxiliary materials, thereby improving the uniformity of the main drug content, and also solving the problem of poor adhesion and fluidity after mixing of the drug powder, and the granules are improved after granulation. The fluidity of the material. At the same time, the granulated binder is uniformly dispersed in the granules, improving the compressibility of the tablet production and the fillability of the capsule production. Starting from the granulation concept, this paper expounds the characteristics of the wet granulation process. At the same time, from the perspective of process and GMP, the manufacturing requirements and influencing factors of the high-speed mixing granulator are described.
1. Overview of granulation and characteristics of wet granulation
1.1 Common methods of granulation and their respective characteristics
Granulation is often carried out by wet granulation, one-step granulation and dry granulation. Granulation is a process in which a powder of a raw material and a binder are mixed into a soft material, and the particles are dried. However, the soft material is traditionally made of a soft material made of a trough mixer and then wetted by a rocking granular mechanism. However, it is dried into a dry granule by a drying box. This method has low yield, high strength, serious pollution, and long production cycle. The equipment covers a large area. Recently, it has been gradually replaced by a continuous production operation method or a one-step granulation method of high-speed wet granulation and boiling-dry granulation.
1.1.1 trough mixing + rocking granulation
The traditional trough type mixing + swing granulation process features that the respective processes are relatively independent and low in cost. The disadvantages are low production efficiency, high labor intensity, many dead zones in the tank, easy cross-contamination, high dust pollution, and forming effect. Poor, poor fluidity and large difference in tablet weight.
1.1.2 Wet granulation
Today's wet granulation equipment has been developed into high-speed wet granulation, and the high-speed mixing granulator is a granulation equipment that has been developed in recent years and has been applied more frequently. It is also economical. It combines the mixing and granulation process and is carried out in a fully enclosed container. It is characterized by saving time and meeting GMP requirements, good mixing effect, high production efficiency, good particle and sphericity, good fluidity, easy cleaning and no pollution, stable content and low energy consumption. It is a kind of equipment with large amount of granulation, fast speed, good granules and low energy consumption, which is very popular among users. At present, several solid preparation processes have accounted for 70% of all solid preparation granulation equipment. However, it has certain requirements for the granulated materials.
1.1.3 one-step granulation
One-step granulation (also called fluidized bed granulation) integrates mixing, granulation and drying, and the granulated finished granules are relatively loose, with a particle size of about 40-80 mesh. It is characterized by high production efficiency, low labor intensity, low external pollution and neat tidying of finished products. The disadvantage is that the power consumption is high and the control parameters vary from species to species.
1.1.4 Dry granulation
Dry granulation is carried out by pressing a powder mixture into a large piece and then pulverizing and granulating to prepare granules of a desired particle size, which is suitable for a moist heat sensitive drug. Dry granulation equipment is characterized by less equipment required, small floor space, time and labor saving, and the tablet is easily disintegrated due to the absence of binder in granulation. The disadvantage is that the "dumping dust" is serious when the tablet is pressed, and the cross-contamination is easily caused, and the dissolution rate of the pressed particles is slow, so it is not suitable for the water-soluble drug.
1.2 Principle and application of wet granulation equipment
In the wet granulation equipment, the horizontal high-speed mixing granulator is mainly used. The principle of granulation of the horizontal high-speed mixing granulator is that the two processes of mixing and granulation are completed in the same container, and the bottom-rotation stirring is used, and the stirring slurry is installed on the bottom of the pot, and a gap is formed with the bottom of the pot. Stirring the foliar surface ensures that the material collides and disperses into a semi-flowing tumbling state and achieves adequate mixing. As the adhesive is injected, the powder is gradually wetted and the shape of the material changes. The rotary motion of the chopping knife and the stirring slurry on the horizontal axis of the pot wall generates eddy currents, so that the materials are fully mixed, turned and collided. At this time, the chopping knife in the area where the material is turned over can fully break up the dough material. Particles. At the same time, the material is squeezed, collided, rubbed, sheared and kneaded between the particles in three-dimensional motion, so that the particles are more uniform and finer in friction, and the zui finally forms stable spherical particles to form a wet and uniform soft material. Among them, the size of the granules is limited by the characteristics of the material, the rotation speed of the knives and the granulation time.
Wet granulation is often used in solid preparations for medicines that require the addition of a binder (such as alcohol, dextrin, etc.) for granulation. It is also suitable for 1 tablet when adding adhesive to enhance the compressibility and adhesion of the powder; 2 when the capsule filling or tableting requires fluidity, usually liquid and high dose materials can be used; 3 pairs of low The dosage of the drug is evenly distributed and the color is good, and can also be solved by this method; 4 the solid preparation can also be used in this method to increase the dissolution rate of the drug by using a suitable solvent and a binder.
In addition, the horizontal high-speed mixing granulator has a working time of less than 10 minutes per batch, and can produce 80 to 200 kg, which is 4-5 times higher than the traditional process. Secondly, the binder is reduced by 25% compared to the conventional process, and the drying time is shortened. The granules are approximately spherical and have good fluidity. At the same time, the outlet can be connected to the boiling and drying, and the powder can be added to the wet granulator by a hoist or a vacuum feeder.
1.3 Comparison of common methods of wet granulation and horizontal high-efficiency wet granulation
There are two types of wet granulation equipment: horizontal and vertical. Generally speaking, the horizontal wet granulator is superior to the vertical one. The following can be seen by comparing horizontal and vertical wet granulation equipment:
Project a horizontal granulator, a vertical granulator
Energy consumption, low energy consumption (about double)
Weight appearance, compact equipment, light weight, high structure, heavy equipment (about 3 times)
The structure is simple, the maintenance of the mixing drum is carried out along the guide rail of the bed, the structure is complicated, and the maintenance is complicated.
It is convenient to open the cover, and can observe the current situation of granulation through the observation hole. It can be sealed and operated without oil and dust. The pot is lifted along the guide rail, and the stirring position is restricted by the material device. There is dust phenomenon (instantaneous), and the seal is easy to cause oil stain.
Linkage and boiling dryer linkage integration is difficult to integrate with other drying equipment
2. Functional requirements for high-speed mixing granulators
1) The paddle is dry mixed with the material, and the binder is added and wet mixed. According to the characteristics of the material and the adhesive, the rotation speed of the stirring paddle ensures that the motion generates eddy current and the material is thoroughly mixed. At the same time, the material of the tumbling knife at the intersection of the granules is fully broken into granules.
2) The rotation speed of the stirring paddle and the granulating knife can make the material produce three-dimensional motion, and the particles will collide, rub and shear, making the friction uniform and meticulous, and the stable spherical particles are shaped after the Zui. The mixing time, the speed of the stirring paddle and the granulating knife, the granulation quality after drying and the uniformity satisfy the requirements of the solid preparation process.
3) The mixing granulation process should be in the closed state, the whole process of mixing granulation (including feeding, mixing, cutting granulation and unloading, etc.) should work under the cleanliness of 100,000 or 300,000 grades, and ensure no foreign matter. fall.
4) The machine can be connected with the boiling drying or lifting feeding or vacuum feeder equipment.
3. Brief introduction of the influencing factors of high-speed mixing granulation mechanism
Generally speaking, the particles prepared by wet mixing granulation are irregular in shape, uniform in particle size distribution, and the structure is better than other conventional granulation processes, but the granulated finished product involves many factors, and its influence is now Brief description.
3.1 The influence of the stirring paddle and the cutting knife speed
It can be said that the size and distribution of the particle size are directly related to the rotation speed of the stirring paddle and the cutting blade. When the cutting speed is slow, the particle size becomes larger, while the rotating speed is faster, the particle size becomes smaller; when the stirring paddle rotates slowly, the particles The particle size is small, and the particle diameter is large as the rotation speed is fast, and the two functions are opposite.
3.2 Effects of mixing, granulation procedures and time
Because in the operation of the high-speed mixing granulator, the rotation of the stirring paddle causes the material in the pot to roll to the space, so that the material of the bottom of the pot is thrown along the wall of the pot. This action pushes the soft material to the quick cutting knife one by one, and is The particles are cut into different sizes, and are rounded and gradually spherical as the particles roll over each other for a while. It can be seen from the above that the speed and time of the stirring paddle and the cutting blade affect the particle size of the granulation.
3.3 Influence of materials and concentration
In wet mixed granulation production, alcohol granulation or dextrin binder is commonly used for granulation, and the adhesion of the two is somewhat different. It is common to use alcohol to make granules. The granules are small and fine, and easy to dry. This is because alcohol does not have viscosity, and it has a loose effect. It is ideal for granulation of Chinese medicine with high viscosity. When the paste is used to refine the granules, the granules produced are large and coarse, and the drying is slow. This is because the dextrin is sticky and has a polymerization effect, and the medicinal preparation having no viscosity is preferred.
In addition, whether it is diluted with concentrated extract as a material or a material using dextrin or other binder, when producing smaller particles, the slurry concentration of the material can be thinner. When larger particles are required, the material is The slurry concentration can be slightly stronger.
4 Conclusion
Based on the characteristics of granulation concept and wet granulation process, from the perspective of corresponding process and GMP, the manufacturing requirements and influencing factors of high-speed mixing granulator are described. The purpose is to raise the level of personnel operation in China to a higher level. Level.
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