The production process of effervescent tablets (2)
Process route determination
At present, the manufacturing process of effervescent tablet sugar has two types: tableting after tableting and direct tableting. The production process of the tablet after granulation can be further divided into two types: wet granulation and dry granulation, and the direct compression has two kinds of powder compression and crystallization compression. However, there are many tablets produced by wet granulation at present.
1. Post-granulation tableting process
(1) The purpose of granulation:
1 The fine powder of the material has poor fluidity and is not easy to uniformly flow into the die hole, thereby affecting the accuracy of the weight of the tablet, and the pellet forming can overcome the difficulty of tableting due to poor fluidity.
2 There is a certain amount of air in the gap between the powders of the particles. When the tablet is molded and pressurized, part of the air in the powder cannot escape in time and is pressed into the sugar sheet; when the pressure is released, the air inside the sugar sheet expands and causes looseness. Cracking; at the same time, the powder tableting has high requirements on the tableting machine and is easy to cause mechanical damage. After being made into granules, the pressure is required to be smaller than that of the powder. Because the surface of the granules is not flat, there is an "intercalation" effect, which can overcome the quality problems such as loosening of the granules.
3 Different raw material powders in the ingredients have a large difference in specific gravity. In the process of sheet forming, the light and heavy components are layered due to the vibration of the tableting machine, and the composition of the tablet is inconsistent and the content is uneven.
4 Solve the quality problems such as fine powder easy to stick and avoid the fine powder flying when the powder is directly pressed.
For the above reasons, in addition to some crystalline raw materials for direct compression molding, powdered raw materials are generally pelletized after granulation.
(2) Wet granulation process:
The preparation method of the effervescent tablet sugar wet granulation is as follows: the acid and the alkali and the appropriate raw and auxiliary materials are respectively grouped into soft materials and granules by using a binder, and are separately dried, granulated and mixed, and then compressed. grain. The specific operation methods are one-step method, two-step method, three-step method and fusion method. The so-called several-step method is divided into several groups of granulation. The three-step method is to divide the raw and auxiliary materials and the acid-base system into three groups, and separately make three groups of soft materials and wet granules, and dry them in groups. The process:
1 Preparation and pretreatment of raw materials: Before the granulation, the raw materials and auxiliary materials generally need to be pulverized, sieved or dried. The fineness of the materials is generally suitable through 80-100 mesh sieves.
2 Material mixing: Pour all kinds of materials into the mixer according to the formula requirements and mix well.
3 made of soft material: the mixed material is placed in the trough mixer, stirred and mixed, add appropriate amount of wetting agent or binder. The type and amount of binder should be selected according to the nature of the material. The temperature and mixing time should be flexibly controlled so that the binder can be evenly distributed and penetrated into the dry powder. When the material is slightly bonded into a block shape, it is a soft material, and the stirring can be stopped. The quality of the soft material is generally clenched into clumps, and the fingers are gently pressed and cracked open.
4 Wet granules: The soft materials are passed through a suitable sieve to form wet granules. Mass production of the swing granulator, the particles should be complete, fine powder should not be too much. If it is long or thick, it will be firmer when it is sieved, and the particles containing fine powder will be looser. The lobes should be made of a variety of granules that are firm, viscous and difficult to disintegrate into loose granules. Generally, it is sieved once, but for colored varieties or varieties with solid particles, multiple sieving can be used. For example, using 8 to 10 mesh sieves for 1 to 2 times, and then passing through 12 to 14 mesh sieves, can be better. Particles. Wet granules with different thickness and tightness should be prepared according to the nature of the material and the requirements of the variety.
5 Drying: After the wet granules are made, they should be dried immediately, and the rotation is too long to be easily deformed or agglomerated. Drying temperature and drying process should pay attention to the following aspects: general material drying temperature is preferably 50-60 ° C; for heat stable materials, drying temperature can be appropriately increased to 75-80 ° C to shorten drying time; containing too much crystal water The material should not be too high in drying temperature, and the time should not be long, so as to avoid losing too much crystal water, making the particles crunchy or affecting disintegration or making tableting difficult; the temperature should be gradually increased during the drying process, otherwise the surface of the particles will turn yellow. The sugar tablets are spotted; if there are sugar powder and starch in the granules, the temperature suddenly causes the sugar to melt, the starch gelatinizes and the granules are hard, the flaky spots are spotted, and the sugar tablets are disintegrated. When the sugar and the acid coexist, they are bonded to a hard block when they are slightly heated.
6 whole grain: wet grain is called dry grain after drying. Since a part of the particles adhere to each other in the drying process, it is necessary to sift the granules into particles which are uniform in size and easy to be tablet-formed. The dry granules are sieved through a granulator (or granulator) to prevent excessive fines from being formed, and then the sifted lubricant is added and stirred well. If you need to add dry starch as a disintegrant, you should also add it at the time of the whole grain.
7 Total mixing: It is a post-dry operation of dry granules. The purpose is to make the various components in the dry granules uniform, and the V-shaped mixer is commonly used in production. The dry particles after mixing are immediately placed in the container, and the samples are to be inspected and then tableted. Small quantities can also be mixed by hand.
8 tablet molding: the process of press molding the pellets in a tablet press. The tableting steps are as follows:
Adjust the weight of the produced varieties to make them consistent; then add, compress, push, and complete the tableting process.
9 Picking: Remove the unacceptable pieces of sugar from the formed tablet.
10 Packing: It is carried out with a blister machine or a pillow packing machine. It is required to be sealed, airtight, and the package is beautiful and complete.
The effervescent tablet made by the wet granulation process usually has a large disadvantage of being easily hygroscopic and having cracks.
(3) Fluidized spray drying granulation method:
The raw materials and the auxiliary materials are mixed, the binder is stirred and granulated, and the operation steps such as drying are completed in one apparatus, which is also called one-step granulation.
The principle of operation is to suspend the powder by airflow, fluidize it, and then intermittently spray the binder, so that the powder first forms nuclear particles and then gradually aggregates into particles of uniform size. The hot gas passes through the particles and exchanges heat dynamically to make the particles rapidly. dry. In operation, the material is placed in a conical container. The bottom of the container is a perforated plate. The 80-100 mesh stainless steel screen is placed on the upper surface, and the blower is driven to allow air to enter the granulator from the bottom through the air inlet through the filter device after heating. The granulator is under negative pressure and the material moves upwards. When the upper part is reached, the pressure is relatively decreased, so it moves downwards, so that the up and down tumbling shape is like boiling. Fluidize evenly for a few minutes, then intermittently spray the binder liquid to gradually condense the powder into granules. Since the dry hot air flows from the bottom of the granulator to the top, after the particles are in full contact, the water is removed, so the heat The utilization rate is high and the humid air escapes through the upper bag filter. The resulting dry granules are subjected to the same operation as granulation, total mixing, and the like.
Advantages of fluidized spray drying granulation method: The whole granulation operation is completed on one piece of equipment, which simplifies the granulation step, and the equipment occupies less space; the granulation operation is continuously carried out, the operation process time is short, labor saving and production efficiency are saved. High; uniform particle size, good fluidity and can adjust the particle thickness arbitrarily, the product quality is stable; under the negative pressure, the operation can be avoided, and the powder can be avoided, and the automatic control program can be realized.
The key to fluidized spray drying granulation: the choice of adhesive in the process, the precise design of the nozzle on the equipment. To solve the above two key problems, more varieties can be developed.
The degree of drying of the granules can be controlled by the determination of the water content. In the production, it is generally used to grip the dry granules. After the hands are released, the granules cannot be bound into a mass; the dry granules are placed between the index finger and the thumb, which can be pulverized without moisture.
Quality requirements for dry granules: Determination of water content: The water content in the granules should be controlled within a certain range. The moisture content of the dry granules is determined according to the specific variety. The moisture is usually obtained at a certain temperature, a certain drying time and the yield of dry granules; the moisture content of the granules is also determined by a moisture rapid tester. In addition to the determination of water content, it is also necessary to grasp the tightness, thickness and color of the particles.
(4) Dry granulation:
Generally, the material is mixed by rolling method, and then uniformly rolled by a rolling machine (double drum mixing machine) and pressed into a sheet of desired hardness and thickness, into a granulation mechanism, a lubricant is added, and then a V shape is formed. The mixer can be pelletized after it has been mixed. However, since the sheet pressed by the method is easy to be layered, cracks may be generated when the sheet is formed, and the apparatus used is bulky, so it is not generally used.
2. Direct tableting process
Refers to the method of directly compressing the powder raw materials after sieving and mixing.
The advantages of direct powder tableting: simplify the production operation of compressed sugar, shorten the production cycle, and make the production equipment simple, which is conducive to automation and continuous; without the wet heat process.
(1) The material to be directly compressed must have a certain thickness, crystal form and compressibility.
(2) In order to directly compress the material powder, it is necessary to add a suitable dry binder, a flow aid, a disintegrant, and the like.
(3) Due to the presence of more air in the powder, cracks are likely to occur during tableting, and the powder is more flying. The crack is overcome by the increased pressure method, and the powder flying is overcome by the closed method.
In addition to the direct compression of the powder, there is also a direct direct compression process. Some crystalline granular raw materials have good fluidity and compressibility, and many materials containing crystal water can be directly compressed by adding an appropriate amount of lubricant. However, it is easy to burst during the tableting process and should be checked.
At present, the dry direct compression process still has certain defects, and the requirements for the tablet press are high. This large pressure is more serious to the compression of the tablet press and the die, which will greatly shorten the service life of the device and at the same time compress the tablet. In the process, the powder will fly, which will pollute the production environment and endanger the health of the employees. It will also cause waste of raw and auxiliary materials and increase production costs.
3. Disintegrator addition method
(1) Common disintegrant addition methods generally have the following three methods of addition:
1 Internal addition method: starch is added to the original auxiliary material, and after mixing, it is made into granules, and disintegration occurs inside the granules, and most of the compressed sugar is used in this method.
2 Addition method: Dry starch is added to the prepared dry granules, and the amount is generally 5% by weight of the dry granules. This method of disintegration occurs between the particles and is often used when the problem of tableting sugar disintegration occurs.
3 mixed addition: mixing the appropriate amount of starch in the ingredients with other raw materials to granulate, and the rest is made into dry starch mixed with dry granules, which has both disintegration effects.
(2) Effervescent disintegrant addition method generally has the following two methods of addition:
1 Internal addition method: the disintegrant is mixed with other materials in the formula to form granules, and the ratio of the disintegrant present in the interior and the surface of the granule is 50-75% and 25-50%, respectively, of the disintegrant amount. The two-step addition method enables the effervescent tablet to immediately collapse into particles before tableting, and the particles are further broken into the original powder, and its disintegration effect is more complete than the addition method.
2 Addition method: that is, the disintegrating agent and the particles are mixed before the tableting, and then tableting is performed.
Seven, the choice of equipment
1. Selection of granulating equipment
(1) Crusher: The pulverizing action of the pulverizer is shearing, impacting, grinding, squeezing, splitting, and the like. There are mainly two types of percussive high-speed pulverizers and round-screen wind-speed high-speed pulverizers.
(2) Mixing machine: When using soft material, the trough mixer is often used; and when the lubricant is added before the tableting, the mixing cylinder is often used, for example, the V-shaped mixing cylinder, that is, the mixing of the particles and the auxiliary materials in the mixing cylinder for a suitable time.
(3) Granulator: The swing type pellet machine and the rotary pellet machine are often used. A rotary granulator is preferred to prevent metal from being introduced into the granule due to rupture of the screen.
2. Drying equipment selection
(1) Box dryer: The oven is dry and the structure is simple. When drying with this type of dryer, the soluble components contained in the granules can "migrate" between the granules, causing differences in the content of soluble components between the granules, affecting the uniformity of the granules, so during the drying process Frequently flip the particles inside the plate. This not only reduces the difference in the content of soluble components between the particles, but also accelerates drying. Drying in an oven usually takes 2 hours.
(2) Fluidized bed dryer: A method of "fluidizing" wet particles with hot air and performing heat exchange and drying in a fluidized state. Multi-purpose vertical boiling dryer, the drying speed is fast, generally can be completed within 1h, which can reduce the labor intensity. Since the particles are not in close contact during the drying process, the soluble components have less chance of interparticle migration and are favorable for maintaining a uniform state. (3) Fluidized spray granulation: Also known as one-step granulation method, this method can be mixed, granulated, dried, etc. and completed in a set of equipment.
The advantages and disadvantages of drying room and fluidized bed drying equipment are as follows:
Drying room advantages: suitable for all varieties and small batch production. Disadvantages: long drying time, high labor intensity and low production efficiency.
Advantages of fluidized bed: low drying temperature, uniform drying, high utilization of heat energy; convenient operation, large output, high labor productivity, suitable for continuous operation of the same variety. Disadvantages: The equipment is not easy to clean.
3. Tablet molding machine selection
(1) Single punching machine : generally used for trial production or small production of new products.
(2) Rotary tablet press : It is a widely used tablet press. The feeding method is reasonable, the difference in tablet weight is small, the pressure is increased from the upper and lower sides, the pressure distribution is uniform, and the output is high.
(3) Double-layer and multi-layer laminating machine : It is a special equipment for double-layer and multi-layered laminated sugar. Equipped with a matching hopper and a quantitative feeder, the structural principle is similar to that of a rotary tablet press.
Determination of packaging form and packaging materials: The packaging of effervescent tablets can be packaged in the form of pillow-type heat seal, å·» fruit tin foil, goldfish folding type, small cylindrical plastic bottle. In general, the common packaging form of effervescent tablet sugar is to use the packaging form of the tablet, that is, the blister package using the plastic packaging and the aluminum foil composite packaging.
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