In addition to some crystallinity or drugs for direct compression, generally powdered drugs need to be pelletized before they can be compressed. Here is the small particle machine we are going to talk about. The reason is: 1 powder is poor in fluidity, not easy Evenly filled in the die hole, causing the powder bridge, the looseness of the loose piece or the weight of the piece exceeds the limit; 2 the fine powder contains a lot of air, part of the air can not escape from the die gap in time when the tablet is pressed, and then expands after decompression , resulting in pine flakes, top cracks and other phenomena; 3 due to the different density of the components of the tablet, easy to stratify due to machine vibration, resulting in uneven content of the main drug. If the color of the raw materials is different, there will be spots of flowers; 4 powder tableting will easily cause the fine powder to fly and lose, and the sticky powder will easily adhere to the surface of the punch to cause sticking and pulling. The above disadvantages can be overcome if the drug is made into particles of a certain size.
1. Wet granulation method mainly includes several processes such as making soft materials, making wet granules, drying wet granules and granules.
(1) Making soft materials: Put the raw materials and auxiliary materials into a mixer, add appropriate amount of wetting agent or binder, and mix them into soft materials. Small quantities can be mixed by hand, and in large quantities, mixers are used.
The dryness and wetness of soft materials should be appropriate. The production should be mastered by experience. It can be clumped by hand without sticking to the hand, and can be cracked with a finger. In recent years, the meter has been designed to measure the momentum torque of the particles in the mixer, which can automatically control the end point of the soft material, thus ensuring the quality of the soft material.
(2) Wet small granulator: The soft material is pressed into a suitable sieve to form granules. In a small amount of production, you can use your hand to hold the soft material into a clump, and gently press the screen with your palm. When the granules fall from the sieve hole and grow into a strip shape without being granulated, it indicates that the soft material is too wet, and the binder or the wetting agent is excessive. On the contrary, if the soft material passes through the sieve hole and is powdery, it indicates that the soft material is too dry and should be properly adjusted.
Granular mechanism pellets are used in factory production. Zui's commonly used granulators are rocking granulators and high-speed agitating granulators. The swaying granulator is a soft material placed in a stainless steel hopper. The lower part is equipped with six hexagonal prisms that revolve around the axis and rotate. The lower screen is fixed by the fixture and abuts against the prism. When the prism is reciprocated, the soft material is pressed and smashed through the sieve to form wet particles.
The screen is usually made of nylon wire, galvanized iron wire or stainless steel wire. The nylon mesh does not affect the stability of the drug, and has elasticity. When the soft material is relatively sticky, the sieving is slow, and the soft material is repeatedly stirred to make the granules have a higher hardness. Galvanized iron wire has no such shortcomings, but it is easy to bring metal chips into the particles, and may also affect the stability of certain drugs. Stainless steel wire mesh is better.
(3) Drying of wet granules: After the wet granules of the small granulator are made, they should be dried immediately to avoid agglomeration or deformation under pressure. The drying temperature is determined by the nature of the raw material, and is usually 50 to 60 ° C. Some drugs that are stable to damp heat are used to shorten the drying time, and the drying temperature can be appropriately increased to 80 to 100 °C. For drugs containing crystal water, the drying temperature should not be high, and the time should not be long, because the loss of excessive crystal water can make the particles crisp and affect the tableting and disintegration. The temperature should be gradually increased during drying, otherwise the surface of the particles will dry and form a hard film to affect the evaporation of internal moisture. If there is starch or powdered sugar in the granules, it may cause gelatinization or melting when it encounters high temperature, making the granules hard and not easy to disintegrate.
The degree of drying of the small pellet machine particles can be controlled by measuring the water content. Granules should generally have a suitable water content, too much water content, easy to stick, and too low is not conducive to tableting. In the production, the method can be measured by a suitable method, but it takes a lot of time. Generally, it is mastered by experience, that is, the dry particles are gripped by hand, and after the hand is relaxed, the particles should not be bound into a mass, and the palm should not adhere to the fine powder. Or when using the index finger and thumb to take dry granules, it should be smashed immediately, without moisture.
There are many types of dry equipment, and there are commonly used heating and drying equipment such as box type (such as oven, oven) dryer, boiling dryer, microwave dryer or far infrared drying.
2. Fluidized spray granulation method is also called one-step granulation method. The granulation method of the present method combines the steps of boiling mixing, spray granulation and air flow drying in a set of equipment, realizes one-step granulation, reduces the process and equipment, facilitates the automation of the production process, and reduces the dust flying loss. Conducive to labor protection.
3. Spray granulation method, the raw materials and granules used for granulation are mixed with a binder, and continuously stirred to prepare a uniform suspension containing solids of about 50% to 60%, and then the suspension is passed through a pump. The high pressure nozzle or the tray is input into a special atomizer to atomize the hot air stream to form fine droplets, and after drying, fine particles of approximately spherical shape are obtained.
4. Wet mixing granulation method is to complete mixing, soft material, granulation and spheronization. There are many high-efficiency wet mixing granulators produced in China. The machine is sealed and granulated, with sufficient mixing, uniform granulation, round particles and good fluidity, which can improve the quality of tablets and the efficiency of tableting.
In addition, there is a spherical granulator which can rotate cylindrical particles made by ordinary wet granulation, spray granulation, etc., into spherical particles to increase the fluidity of the particles. The granules after the granules are combined with an excellent glidant will create favorable conditions for high speed tableting.
The granulating equipment has developed rapidly. Modern granulating equipment has its own characteristics, many program control devices, high efficiency, less material loss, and less cross-contamination. Many equipments have been successfully tested or introduced in China.
1. Wet granulation method mainly includes several processes such as making soft materials, making wet granules, drying wet granules and granules.
(1) Making soft materials: Put the raw materials and auxiliary materials into a mixer, add appropriate amount of wetting agent or binder, and mix them into soft materials. Small quantities can be mixed by hand, and in large quantities, mixers are used.
The dryness and wetness of soft materials should be appropriate. The production should be mastered by experience. It can be clumped by hand without sticking to the hand, and can be cracked with a finger. In recent years, the meter has been designed to measure the momentum torque of the particles in the mixer, which can automatically control the end point of the soft material, thus ensuring the quality of the soft material.
(2) Wet small granulator: The soft material is pressed into a suitable sieve to form granules. In a small amount of production, you can use your hand to hold the soft material into a clump, and gently press the screen with your palm. When the granules fall from the sieve hole and grow into a strip shape without being granulated, it indicates that the soft material is too wet, and the binder or the wetting agent is excessive. On the contrary, if the soft material passes through the sieve hole and is powdery, it indicates that the soft material is too dry and should be properly adjusted.
Granular mechanism pellets are used in factory production. Zui's commonly used granulators are rocking granulators and high-speed agitating granulators. The swaying granulator is a soft material placed in a stainless steel hopper. The lower part is equipped with six hexagonal prisms that revolve around the axis and rotate. The lower screen is fixed by the fixture and abuts against the prism. When the prism is reciprocated, the soft material is pressed and smashed through the sieve to form wet particles.
The screen is usually made of nylon wire, galvanized iron wire or stainless steel wire. The nylon mesh does not affect the stability of the drug, and has elasticity. When the soft material is relatively sticky, the sieving is slow, and the soft material is repeatedly stirred to make the granules have a higher hardness. Galvanized iron wire has no such shortcomings, but it is easy to bring metal chips into the particles, and may also affect the stability of certain drugs. Stainless steel wire mesh is better.
(3) Drying of wet granules: After the wet granules of the small granulator are made, they should be dried immediately to avoid agglomeration or deformation under pressure. The drying temperature is determined by the nature of the raw material, and is usually 50 to 60 ° C. Some drugs that are stable to damp heat are used to shorten the drying time, and the drying temperature can be appropriately increased to 80 to 100 °C. For drugs containing crystal water, the drying temperature should not be high, and the time should not be long, because the loss of excessive crystal water can make the particles crisp and affect the tableting and disintegration. The temperature should be gradually increased during drying, otherwise the surface of the particles will dry and form a hard film to affect the evaporation of internal moisture. If there is starch or powdered sugar in the granules, it may cause gelatinization or melting when it encounters high temperature, making the granules hard and not easy to disintegrate.
The degree of drying of the small pellet machine particles can be controlled by measuring the water content. Granules should generally have a suitable water content, too much water content, easy to stick, and too low is not conducive to tableting. In the production, the method can be measured by a suitable method, but it takes a lot of time. Generally, it is mastered by experience, that is, the dry particles are gripped by hand, and after the hand is relaxed, the particles should not be bound into a mass, and the palm should not adhere to the fine powder. Or when using the index finger and thumb to take dry granules, it should be smashed immediately, without moisture.
There are many types of dry equipment, and there are commonly used heating and drying equipment such as box type (such as oven, oven) dryer, boiling dryer, microwave dryer or far infrared drying.
2. Fluidized spray granulation method is also called one-step granulation method. The granulation method of the present method combines the steps of boiling mixing, spray granulation and air flow drying in a set of equipment, realizes one-step granulation, reduces the process and equipment, facilitates the automation of the production process, and reduces the dust flying loss. Conducive to labor protection.
3. Spray granulation method, the raw materials and granules used for granulation are mixed with a binder, and continuously stirred to prepare a uniform suspension containing solids of about 50% to 60%, and then the suspension is passed through a pump. The high pressure nozzle or the tray is input into a special atomizer to atomize the hot air stream to form fine droplets, and after drying, fine particles of approximately spherical shape are obtained.
4. Wet mixing granulation method is to complete mixing, soft material, granulation and spheronization. There are many high-efficiency wet mixing granulators produced in China. The machine is sealed and granulated, with sufficient mixing, uniform granulation, round particles and good fluidity, which can improve the quality of tablets and the efficiency of tableting.
In addition, there is a spherical granulator which can rotate cylindrical particles made by ordinary wet granulation, spray granulation, etc., into spherical particles to increase the fluidity of the particles. The granules after the granules are combined with an excellent glidant will create favorable conditions for high speed tableting.
The granulating equipment has developed rapidly. Modern granulating equipment has its own characteristics, many program control devices, high efficiency, less material loss, and less cross-contamination. Many equipments have been successfully tested or introduced in China.
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