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 Traditional trough mixing + swing granulation is characterized by relatively independent process and low cost. The disadvantages are low production efficiency, high labor intensity, many dead zones in the tank, and easy cross-contamination. "Dispersed dust" has high pollution, poor forming effect, poor fluidity and large difference in tablet weight.
1.1.2 Wet granulation Today's wet granulation equipment has been developed to 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. The granulated finished granules are relatively loose, with a particle size of 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 methods There are two types of wet granulation equipment: horizontal and vertical. Generally speaking, horizontal wet granulator is superior to vertical, and the following is horizontal. This can be seen by comparing with the 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, the maintenance is complicated, the operation is easy to open, the granulation can be observed through the observation hole, the sealing operation can be performed, and the oil-free and dust-free phenomenon of the pot along the guide rail is raised and stirred. Limited by the material device, there is dust phenomenon (instantaneous), the seal is easy to cause the oil pollution linkage and the boiling drying machine can be linked and integrated with other drying equipment. 2. The manufacturing point of the high-speed mixing granulator is compared with the GMP standard and the corresponding process of the solid preparation. The requirements for the manufacture of high-speed mixing granulators (horizontal) should meet the following requirements.
2.1 The functional requirements of the high-speed mixing granulator should be 1) dry mixing of the material by the stirring paddle, wet mixing after adding the binder. 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.
2.2 High-speed mixing granulator overall structure and manufacturing requirements 1) Austenitic stainless steel is used in direct contact with the material, and non-metallic materials should be non-toxic, chemically resistant to chemical changes, and non-corrosive materials that do not absorb chemicals.
2) The granule cylinder is the upper conical cylinder. The bottom of the cylinder should be made by spinning the whole plate. The bottom of the cylinder should be provided with a cooling jacket to ensure that the cylinder does not heat up when it is stirred. The transition of the surface of the cylinder should be a circular arc transition, easy to clean, no dead zone for cleaning. Simultaneously,
The granule cylinders are all welded by argon arc welding, and both internal and external parts need to be polished. Especially, the internal surface polishing surface roughness Ra≤0.8μm ensures that the material will not stick to the wall surface.
3) The feeding port of the granulating cylinder body adopts the quick opening structure, the flange and the barrel body are welded to ensure no dead zone, the cylinder cover is easy to disassemble and open, and the feeding port and the cylinder cover gasket should be sanitary grade silicone rubber, sealed. The pad is easy to change, and the feed inlet and the cap structure should have corresponding airtightness. In addition, the discharge port of the granulating cylinder body adopts an electronically controlled discharge valve, and the valve plate gasket should be sanitary grade silicone rubber, and the entire passage surface of the discharge material is smooth, easy to clean, and has no dead angle of cleaning.
4) The stirring paddle adopts the bottom-rotating agitation. The welding adopts argon arc welding, and both need to be polished. The strength of the connection between the agitating impeller and the bushing should be increased to overcome the instantaneous torque. In addition, the distance between the bottom of the pot and the bottom of the stirring paddle is small (≤1mm) to solve the problem of material accumulation at the bottom of the pot. At the same time, the chopping knife adopts the side-mounted type, the blade is convenient to exchange, and the whole chopping knife assembly has no cleaning dead zone. Among them, the stirring drive shaft and the cylinder seal are easy to seal with air, and can be sealed by water sealing. The sealing of the stirring drive shaft and the cylinder and the sealing of the granulating cutter shaft and the cylinder should be reliably sealed to prevent the powder layer from entering and avoid cross contamination.
5) Austenitic stainless steel polishing tube for gas and water pipelines, using argon arc welding or quick opening connection. When necessary, the gas and water pipelines shall be provided with terminal filters. At the same time, the internal cleaning is convenient. The gas and water pipes can be connected to the shunt ring at the shaft. When the water vapor is converted, the water pressure can be sprayed to various positions of the cylinder to ensure that there is no blind zone for cleaning, and the drain port should be set at a low position.
6) Lubricants cannot be used on the surface of exposed parts, and the lubrication points inside the drive that need to be lubricated shall not cause any pollution to the exposed structure.
7) There must be a mechanical overload protection device. In addition, the compressed air line should be provided with a pressure relief or safety device.
2.3 Electrical and control requirements of high-speed mixing granulator 1) The speed of the stirring paddle and the chopper knife can be at least two-speed motor speed change, the speed range of the stirring paddle is 30-500 rpm, the speed of the chopper knife is 300-3000 rpm, and the frequency can be changed. Speed ​​regulation and setting display.
2) For the two-speed simple control, the control is equipped with start, emergency, stop switch and fault display, and has current display and second gear motor shift display.
3) When the discharge valve or the drain is closed, the motor that stirs the slurry and the chopper can only run, and vice versa. In addition, the cleaning process can only be entered when the discharge valve is closed.
4) The electrical control should have a self-protection function to prevent damage to the equipment caused by misoperation. These include main motor fault protection and emergency stop protection.
5) For high-end configuration, it should be controlled by PL+ touch color LCD panel. The interface design is divided into manual trial operation interface and normal operation interface, and has a good man-machine dialogue interface. The interface dynamically reflects the main processes (feeding, mixing, cutting granulation, unloading and CIP). The process menu selection and parameters (mixing paddle and granulator speed, mixing and granulating time, CIP time, etc.) can be set to display the set parameters, actual operating parameters, and the cause of the malfunction, as well as the memory function.
2.4 Basic technology and verification requirements of high-speed mixing granulator 1) Operating noise ≤ 75dB (A);
2) The speed of the stirring paddle and the granulating knife is in accordance with the process requirements of the corresponding solid preparation;
3) Mixed granulation speed, in line with production requirements;
4) The mixing granulation time is in accordance with the process requirements of the corresponding solid preparation (generally 10-15min/batch);
5) The speed of the stirring paddle and the chopping knife is in accordance with the process requirements of the corresponding solid preparation;
6) Yield >99%;
7) The particle size range of the granulated product is Φ0.17mm-Φ0.83mm (20 mesh-80 mesh) (or according to the process requirements);
8) After drying, the granulation quality should be spherical, uniform in particle size and good in fluidity.
3. High-speed mixing granulation mechanism Brief introduction of factors affecting finished grain products 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 traditional granulation processes, but the finished granules are finished. It also involves the influence of many factors, and its impact is now briefly described.
3.1 The influence of the rotation speed of the stirring paddle and the cutting blade 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, and when the rotating speed is faster, the particle size becomes smaller. When the stirring paddle speed is slow, the particle size is small, and the particle speed is large as the rotation speed is fast, and the two functions are opposite.
3.2 The influence of mixing, granulation procedure 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 is successively put on the soft The soft material is pushed to the fast cutting knife and cut into particles of different sizes, and the particles are rounded and gradually become 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 material and concentration In wet mixed granulation production, alcohol granulation or dextrin binder is commonly used for granulation, and the adhesion between the two is determined by a certain difference. 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 make domestic high-speed mixed granulation. The function is better and the perfection is made. Jiangsu One Step Drying Equipment Co., Ltd. is a professional manufacturer of mixing, granulating and drying equipment. Although it is mainly dry equipment, mixing, granulation and drying are mutually coexisting, especially mixed granulation is the production of solid preparations. The basis. The GHL series high-speed mixing granulator produced by our company is a high-quality popular product, especially suitable for the production of small and medium-sized and popular pharmaceutical factories. This product has been used in Shandong Lukang Group, Shandong Lunan Pharmaceutical Co., Ltd., Shandong Xinhua Pharmaceutical Co., Ltd., Jilin Tonghua Dongbao Pharmaceutical, Shijiazhuang Cody Pharmaceutical, Beijing Giant Energy Co., Ltd. and New Zealand BOMAC Company, etc., can also be customized according to needs. We hope that our products will make greater production of solid preparations in China. contribution.
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 Traditional trough mixing + swing granulation is characterized by relatively independent process and low cost. The disadvantages are low production efficiency, high labor intensity, many dead zones in the tank, and easy cross-contamination. "Dispersed dust" has high pollution, poor forming effect, poor fluidity and large difference in tablet weight.
1.1.2 Wet granulation Today's wet granulation equipment has been developed to 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. The granulated finished granules are relatively loose, with a particle size of 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 methods There are two types of wet granulation equipment: horizontal and vertical. Generally speaking, horizontal wet granulator is superior to vertical, and the following is horizontal. This can be seen by comparing with the 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, the maintenance is complicated, the operation is easy to open, the granulation can be observed through the observation hole, the sealing operation can be performed, and the oil-free and dust-free phenomenon of the pot along the guide rail is raised and stirred. Limited by the material device, there is dust phenomenon (instantaneous), the seal is easy to cause the oil pollution linkage and the boiling drying machine can be linked and integrated with other drying equipment. 2. The manufacturing point of the high-speed mixing granulator is compared with the GMP standard and the corresponding process of the solid preparation. The requirements for the manufacture of high-speed mixing granulators (horizontal) should meet the following requirements.
2.1 The functional requirements of the high-speed mixing granulator should be 1) dry mixing of the material by the stirring paddle, wet mixing after adding the binder. 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.
2.2 High-speed mixing granulator overall structure and manufacturing requirements 1) Austenitic stainless steel is used in direct contact with the material, and non-metallic materials should be non-toxic, chemically resistant to chemical changes, and non-corrosive materials that do not absorb chemicals.
2) The granule cylinder is the upper conical cylinder. The bottom of the cylinder should be made by spinning the whole plate. The bottom of the cylinder should be provided with a cooling jacket to ensure that the cylinder does not heat up when it is stirred. The transition of the surface of the cylinder should be a circular arc transition, easy to clean, no dead zone for cleaning. Simultaneously,
The granule cylinders are all welded by argon arc welding, and both internal and external parts need to be polished. Especially, the internal surface polishing surface roughness Ra≤0.8μm ensures that the material will not stick to the wall surface.
3) The feeding port of the granulating cylinder body adopts the quick opening structure, the flange and the barrel body are welded to ensure no dead zone, the cylinder cover is easy to disassemble and open, and the feeding port and the cylinder cover gasket should be sanitary grade silicone rubber, sealed. The pad is easy to change, and the feed inlet and the cap structure should have corresponding airtightness. In addition, the discharge port of the granulating cylinder body adopts an electronically controlled discharge valve, and the valve plate gasket should be sanitary grade silicone rubber, and the entire passage surface of the discharge material is smooth, easy to clean, and has no dead angle of cleaning.
4) The stirring paddle adopts the bottom-rotating agitation. The welding adopts argon arc welding, and both need to be polished. The strength of the connection between the agitating impeller and the bushing should be increased to overcome the instantaneous torque. In addition, the distance between the bottom of the pot and the bottom of the stirring paddle is small (≤1mm) to solve the problem of material accumulation at the bottom of the pot. At the same time, the chopping knife adopts the side-mounted type, the blade is convenient to exchange, and the whole chopping knife assembly has no cleaning dead zone. Among them, the stirring drive shaft and the cylinder seal are easy to seal with air, and can be sealed by water sealing. The sealing of the stirring drive shaft and the cylinder and the sealing of the granulating cutter shaft and the cylinder should be reliably sealed to prevent the powder layer from entering and avoid cross contamination.
5) Austenitic stainless steel polishing tube for gas and water pipelines, using argon arc welding or quick opening connection. When necessary, the gas and water pipelines shall be provided with terminal filters. At the same time, the internal cleaning is convenient. The gas and water pipes can be connected to the shunt ring at the shaft. When the water vapor is converted, the water pressure can be sprayed to various positions of the cylinder to ensure that there is no blind zone for cleaning, and the drain port should be set at a low position.
6) Lubricants cannot be used on the surface of exposed parts, and the lubrication points inside the drive that need to be lubricated shall not cause any pollution to the exposed structure.
7) There must be a mechanical overload protection device. In addition, the compressed air line should be provided with a pressure relief or safety device.
2.3 Electrical and control requirements of high-speed mixing granulator 1) The speed of the stirring paddle and the chopper knife can be at least two-speed motor speed change, the speed range of the stirring paddle is 30-500 rpm, the speed of the chopper knife is 300-3000 rpm, and the frequency can be changed. Speed ​​regulation and setting display.
2) For the two-speed simple control, the control is equipped with start, emergency, stop switch and fault display, and has current display and second gear motor shift display.
3) When the discharge valve or the drain is closed, the motor that stirs the slurry and the chopper can only run, and vice versa. In addition, the cleaning process can only be entered when the discharge valve is closed.
4) The electrical control should have a self-protection function to prevent damage to the equipment caused by misoperation. These include main motor fault protection and emergency stop protection.
5) For high-end configuration, it should be controlled by PL+ touch color LCD panel. The interface design is divided into manual trial operation interface and normal operation interface, and has a good man-machine dialogue interface. The interface dynamically reflects the main processes (feeding, mixing, cutting granulation, unloading and CIP). The process menu selection and parameters (mixing paddle and granulator speed, mixing and granulating time, CIP time, etc.) can be set to display the set parameters, actual operating parameters, and the cause of the malfunction, as well as the memory function.
2.4 Basic technology and verification requirements of high-speed mixing granulator 1) Operating noise ≤ 75dB (A);
2) The speed of the stirring paddle and the granulating knife is in accordance with the process requirements of the corresponding solid preparation;
3) Mixed granulation speed, in line with production requirements;
4) The mixing granulation time is in accordance with the process requirements of the corresponding solid preparation (generally 10-15min/batch);
5) The speed of the stirring paddle and the chopping knife is in accordance with the process requirements of the corresponding solid preparation;
6) Yield >99%;
7) The particle size range of the granulated product is Φ0.17mm-Φ0.83mm (20 mesh-80 mesh) (or according to the process requirements);
8) After drying, the granulation quality should be spherical, uniform in particle size and good in fluidity.
3. High-speed mixing granulation mechanism Brief introduction of factors affecting finished grain products 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 traditional granulation processes, but the finished granules are finished. It also involves the influence of many factors, and its impact is now briefly described.
3.1 The influence of the rotation speed of the stirring paddle and the cutting blade 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, and when the rotating speed is faster, the particle size becomes smaller. When the stirring paddle speed is slow, the particle size is small, and the particle speed is large as the rotation speed is fast, and the two functions are opposite.
3.2 The influence of mixing, granulation procedure 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 is successively put on the soft The soft material is pushed to the fast cutting knife and cut into particles of different sizes, and the particles are rounded and gradually become 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 material and concentration In wet mixed granulation production, alcohol granulation or dextrin binder is commonly used for granulation, and the adhesion between the two is determined by a certain difference. 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 make domestic high-speed mixed granulation. The function is better and the perfection is made. Jiangsu One Step Drying Equipment Co., Ltd. is a professional manufacturer of mixing, granulating and drying equipment. Although it is mainly dry equipment, mixing, granulation and drying are mutually coexisting, especially mixed granulation is the production of solid preparations. The basis. The GHL series high-speed mixing granulator produced by our company is a high-quality popular product, especially suitable for the production of small and medium-sized and popular pharmaceutical factories. This product has been used in Shandong Lukang Group, Shandong Lunan Pharmaceutical Co., Ltd., Shandong Xinhua Pharmaceutical Co., Ltd., Jilin Tonghua Dongbao Pharmaceutical, Shijiazhuang Cody Pharmaceutical, Beijing Giant Energy Co., Ltd. and New Zealand BOMAC Company, etc., can also be customized according to needs. We hope that our products will make greater production of solid preparations in China. contribution.
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