CN114699427A - Hydrotalcite chewable tablet and preparation method thereof - Google Patents

Hydrotalcite chewable tablet and preparation method thereof Download PDF

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Publication number
CN114699427A
CN114699427A CN202210378555.4A CN202210378555A CN114699427A CN 114699427 A CN114699427 A CN 114699427A CN 202210378555 A CN202210378555 A CN 202210378555A CN 114699427 A CN114699427 A CN 114699427A
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hydrotalcite
chewable tablet
air outlet
filter cloth
chamber
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CN114699427B (en
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幸林广
周健
吴雪娟
莫英
李�杰
颜桂春
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Guangxi Nanning Baihui Pharmaceutical Group Co ltd
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Guangxi Nanning Baihui Pharmaceutical Group Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B3/00Drying solid materials or objects by processes involving the application of heat
    • F26B3/02Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air
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    • F26B3/08Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour flowing through the materials or objects to be dried so as to loosen them, e.g. to form a fluidised bed
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Abstract

The invention discloses an hydrotalcite chewable tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The preparation method comprises the following steps: s1, pretreating auxiliary materials; s2, weighing raw materials; s3, preparing slurry; s4, mixing and granulating; s5, drying; s6, granulating; s7, total mixing; s8, tabletting; and S9, packaging. The invention solves the problems of poor mouthfeel, low preparation efficiency and complicated working procedures of the hydrotalcite chewable tablet.

Description

Hydrotalcite chewable tablet and preparation method thereof
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to a hydrotalcite chewable tablet and a preparation method thereof.
Background
The hydrotalcite chewable tablet is mainly used for treating chronic gastritis and stomach discomfort symptoms related to gastric acid, such as stomachache, heartburn (heartburn), acid eructation, satiety and the like.
At present, the hydrotalcite chewable tablet generally has the problems of poor taste, low preparation efficiency, complex process and the like, and in addition, the existing hydrotalcite chewable tablet is mainly prepared by a wet granulation method, so that the method is simple to operate and low in preparation cost, and is widely used. Wet granules obtained after wet granulation are usually required to be dried, and a split boiling dryer is usually adopted for drying at present, so that the boiling dryer not only increases the operation difficulty, but also is easy to cause air leakage and material leakage, and the working efficiency is lower.
In view of this, the present invention provides a hydrotalcite chewable tablet and a preparation method thereof.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a hydrotalcite chewable tablet and a preparation method thereof, which solve the problems of poor taste, low preparation efficiency and complex procedures of the hydrotalcite chewable tablet.
In order to achieve the purpose, the invention provides the following technical scheme:
a chewable tablet is prepared from hydrotalcite and adjuvants, wherein the adjuvants comprise mannitol, corn starch, saccharin sodium, carboxymethyl starch sodium, purified water, powdered herba Menthae essence and magnesium stearate;
wherein, every 500mg of the hydrotalcite is prepared from the following components in percentage by weight: 400mg of mannitol, 80-130mg of corn starch, 0.2-0.8mg of saccharin sodium, 30-50mg of carboxymethyl starch sodium, 500mg of purified water, 1-3mg of powdered mint essence and 5-15mg of magnesium stearate.
More preferably: the granularity of the hydrotalcite is less than 120 mu m.
A preparation method of a hydrotalcite chewable tablet comprises the following steps:
s1, pretreatment of auxiliary materials
Treating mannitol with a swing machine, sieving with a 60-mesh sieve, treating saccharin sodium with a pulverizer, and sieving with a 80-mesh sieve for later use;
s2, weighing raw materials
Weighing the hydrotalcite, mannitol, corn starch, saccharin sodium, carboxymethyl starch sodium, purified water, powdered mint essence and magnesium stearate according to the proportion of the raw materials in the hydrotalcite chewable tablet;
s3 pulp preparation
Putting the weighed corn starch 1/4-1/3 into a stainless steel barrel, adding purified water with twice amount of the corn starch, uniformly dispersing, transferring into a slurry melting pot, adding purified water with twice amount of the stainless steel barrel, washing, transferring into the slurry melting pot, repeating the operation twice, adding the rest amount of the purified water, uniformly stirring, boiling, and keeping boiling for 3 min; keeping stirring and cooling to 60-70 ℃ to obtain starch slurry;
s4, mixing and granulating
Putting the prepared aluminum magnesium carbonate, mannitol, residual corn starch, saccharin sodium and sodium carboxymethyl starch 1/2 into a wet granulating machine, and mixing for 5min at stirring speed of 70 rpm; adding the starch slurry to prepare granules, and then finishing the granules through a square-hole sieve to obtain wet granules;
s5, drying
Drying the wet granules obtained in the step S4 in an integrated boiling dryer to obtain dry granules with the moisture content of less than 4%;
s6, straightening granules
Straightening the dry granules in the step S5 by a straightening granulator of a round-hole sieve;
s7 Total mixing
Putting the powdered mint essence, the residual carboxymethyl starch sodium and the whole dry granules into a mixer, mixing for 10min, adding weighed magnesium stearate, and continuously mixing for 3min at the rotating speed of 5 rpm;
s8, tabletting
Putting the total mixed materials into a tablet machine for tabletting to obtain the hydrotalcite chewable tablets;
s9, packaging
And (5) packaging the hydrotalcite chewable tablets obtained in the step S8 to obtain the product.
More preferably: in step S5, the wet granules obtained in step S4 are placed in an integrated boiling dryer, and the wet granules are dried at the air inlet temperature of 80-85 ℃ and the fan frequency of 30-40HZ until the temperature of the wet granules reaches 60 ℃; stopping heating, measuring the moisture content of the wet granules, and restarting the integrated boiling dryer for drying if the moisture content does not meet the requirement until dry granules with the moisture content of less than 4% are obtained.
More preferably: the integrated boiling dryer comprises a tank body, wherein the tank body sequentially comprises an air inlet chamber, a drying chamber and an air outlet chamber from bottom to top, a hot air inlet is formed in the side part of the air inlet chamber, an air outlet is formed in the side part of the air outlet chamber, and a feeding pipe and a discharging pipe for feeding and discharging materials are arranged in the side part of the drying chamber;
be provided with the screen cloth between intake chamber, the drying chamber, be provided with the filter cloth between drying chamber, the air-out room, jar internal actuating mechanism, rabbling mechanism and the patting mechanism of being provided with, actuating mechanism is used for the drive the rabbling mechanism stirring material in the drying chamber just is used for the drive patting mechanism is right the filter cloth is patted.
More preferably: the driving mechanism comprises a motor and a main shaft;
the motor is located in the air inlet chamber and is installed at the bottom of the screen, the lower end of the main shaft is connected with the output shaft of the motor, and the upper end of the main shaft sequentially penetrates through the screen and the filter cloth and is inserted into the top in the air outlet chamber.
More preferably: the stirring mechanism comprises a supporting cross rod and a supporting vertical rod;
the support horizontal pole with support the montant and all be located in the drying chamber, support horizontal pole one end and fix the main shaft surface, the other end is to being close to the extension of drying chamber lateral wall direction, support montant one end and fix support the horizontal pole surface, the other end to support the radial direction of horizontal pole and outwards extend.
More preferably: the air outlet chamber is internally provided with a buffer mechanism, the buffer mechanism is connected between the filter cloth and the top of the air outlet chamber, and the flapping mechanism is used for flapping the filter cloth up and down so as to enable materials adhered to the surface of the filter cloth to enter the drying chamber.
More preferably: the flapping mechanism comprises a worm, a worm wheel, a rotating shaft and a cam;
the worm, the worm wheel, the rotating shaft and the cam are all located in the air outlet chamber, the worm is arranged on the main shaft, the worm wheel is located on one side of the worm and meshed with the worm, two ends of the rotating shaft are respectively inserted into two opposite sides inside the air outlet chamber, the worm wheel and the cam are fixed on the rotating shaft, and the circumferential surface of the cam is in contact with the top surface of the filter cloth.
More preferably: the filter cloth is arranged in an arc shape, the outer arc surface faces the air outlet chamber, the buffer mechanism comprises a support rod and a spring, the lower end of the support rod is fixed with the filter cloth, the upper end of the support rod is connected with the spring, the lower end of the spring is fixed with the support rod, and the upper end of the spring is fixed with the top in the air outlet chamber.
In conclusion, the invention has the following beneficial effects: the hydrotalcite chewable tablet takes hydrotalcite as a raw material, and mannitol, corn starch, saccharin sodium, carboxymethyl starch sodium, purified water, powdered mint essence and magnesium stearate are added at the same time. In the invention, mannitol is used as an excipient, saccharin sodium is used as a sweetening agent, carboxymethyl starch sodium is used for thickening and bonding, and magnesium stearate is used as a glidant, so that the prepared hydrotalcite chewable tablet has good mouthfeel, is compact and is not easy to disperse. The invention adopts the integrated fluidized dryer to replace the traditional split fluidized dryer to dry wet particles, is more convenient to use and improves the working efficiency.
Drawings
FIG. 1 is a block flow diagram of an embodiment, which is mainly used for embodying the preparation method of the hydrotalcite chewable tablet;
FIG. 2 is a schematic structural diagram of an embodiment, which is mainly used for embodying the structure of the integrated boiling dryer;
fig. 3 is a schematic sectional view of the embodiment, mainly for embodying the mounting structure of the cam.
In the figure, 101, an air inlet chamber; 102. a drying chamber; 103. an air outlet chamber; 2. a hot air inlet; 3. an air outlet; 4. a feed pipe; 5. a discharge pipe; 61. a motor; 62. a main shaft; 71. a support rail; 72. supporting the vertical rod; 81. a worm; 82. a worm gear; 83. a rotating shaft; 84. a cam; 91. a support bar; 92. a spring; 10. filtering cloth; 11. a cover body; 12. a sealing cover; 13. and (4) screening.
Detailed Description
The invention is described in detail below with reference to the figures and examples.
Example 1: a chewable tablet is prepared from hydrotalcite and adjuvants, wherein the adjuvants include mannitol, corn starch, saccharin sodium, carboxymethyl starch sodium, purified water, powdered herba Menthae essence and magnesium stearate. Wherein, every 500mg of the hydrotalcite is prepared from the following components in parts by weight: 347.5mg of mannitol, 104.57mg of corn starch, 0.5mg of saccharin sodium, 40mg of carboxymethyl starch sodium, 561.83mg of purified water, 2mg of powdered mint essence and 10mg of magnesium stearate. The particle size of the hydrotalcite is 100 μm.
The preparation method of the hydrotalcite chewable tablet is shown in figure 1 and comprises the following steps:
s1, pretreatment of auxiliary materials
Treating mannitol with a swing type pulverizer, sieving with a 60-mesh sieve, treating saccharin sodium with a pulverizer, and sieving with a 80-mesh sieve for later use.
S2, weighing raw materials
According to the mixture ratio of the raw materials in the hydrotalcite chewable tablet, hydrotalcite, mannitol, corn starch, saccharin sodium, carboxymethyl starch sodium, purified water, powdered mint essence and magnesium stearate are weighed.
S3 pulp preparation
Putting 29.57mg of the weighed corn starch into a stainless steel barrel, adding purified water with twice the amount of the corn starch, dispersing uniformly, transferring into a slurry melting pot, adding purified water with twice the amount of the stainless steel barrel, washing, transferring into the slurry melting pot, repeating the operation twice, adding the rest purified water, stirring uniformly, boiling, and keeping boiling for 3 min; stirring and cooling to 66 ℃ to obtain 5% starch slurry, wherein the starch slurry is used as an adhesive.
S4, mixing and granulating
Putting the prepared aluminum magnesium carbonate, mannitol, the rest corn starch, saccharin sodium and 20mg of carboxymethyl starch sodium into a wet granulating machine, and mixing for 5min at a stirring speed of 70 rpm; adding starch slurry, granulating, grading with a square mesh sieve, and discharging to obtain wet granules;
preferably, the starch slurry is transferred into a pressure slurry feeding tank above the top of the wet granulator, and the temperature of the starch slurry is measured and should be 55-70 ℃; by using
Figure BDA0003591260680000061
The pressure of the slurry adding tank is adjusted to be 0.35-0.38MPa by a spray head, the stirring speed of the wet granulator is set to be 70rpm, the shearing speed is set to be 1500rpm, 82.8 +/-1.5 kg of 5% starch slurry is sprayed when the wet granulator is started, and the wet granulator is stopped; opening a cover of the wet granulator, cleaning the wall of the pot, sweeping the materials on the inner wall into the pot, and covering the cover; granulating at stirring speed of 70rpm and shearing speed of 1500rpm for 2-5min to obtain granules with suitable size, dryness, wetness, hardness and hardness; and (3) granulating and discharging to an integrated fluidized bed dryer by using an 8 x 8mm square-hole sieve, wherein the granulating speed is 500rpm, and the stirring speed is 1-15rpm, so as to obtain wet granules.
S5, drying
Drying the wet granules obtained in the step S4 in an integrated boiling dryer to obtain dry granules with the moisture content of less than 4%;
preferably, the wet granules obtained in the step S4 are placed in an integrated fluidized bed dryer, and the wet granules are dried at the air inlet temperature of 82 ℃ and the fan frequency of 35HZ until the temperature of the wet granules reaches 60 ℃; stopping heating, measuring the moisture content of the wet granules, and restarting the integrated boiling dryer for drying if the moisture content does not meet the requirement until dry granules with the moisture content of less than 4% are obtained.
S6, straightening granules
The dry granules obtained in step S5 were granulated by a granulator having a diameter of 1.2mm circular sieve at a granulation speed of 700 ± 50 rpm.
S7 Total mixing
And (3) putting the powdered mint essence, the residual carboxymethyl starch sodium and the whole dried granules into a mixer, mixing for 10min at the rotating speed of 5rpm, adding weighed magnesium stearate, continuously mixing for 3min at the rotating speed of 5rpm, and discharging.
S8, tabletting
And (3) putting the total mixed materials into an S250smart tablet press for tabletting, and selecting an inclined flat punching die with the specification of phi 16mm to obtain the hydrotalcite chewable tablet.
S9, packaging
And (5) packaging the hydrotalcite chewable tablets obtained in the step S8 to obtain the product.
Preferably, the packaging specifications are: 10 pieces x 2 panels x 400 boxes/case.
Referring to fig. 2-3, the integrated boiling dryer includes a cylindrical tank body, and the tank body sequentially includes an air inlet chamber 101, a drying chamber 102, and an air outlet chamber 103 from bottom to top. A hot air inlet 2 is arranged on one side of the lower part of the air inlet chamber 101, an air outlet 3 is arranged on one side of the lower part of the air outlet chamber 103, and a feeding pipe 4 and a discharging pipe 5 for feeding and discharging materials are arranged on the side part of the drying chamber 102. The feeding pipe 4 is located on one side of the upper part of the drying chamber 102, one end of the feeding pipe is connected with the drying chamber 102, the other end of the feeding pipe is inclined upwards and is integrally connected with a feeding hopper, and a cover body 11 is arranged on the upper cover of the feeding hopper. The discharging pipe 5 is located on one side of the lower portion of the drying chamber 102, one end of the discharging pipe is connected with the drying chamber 102, the other end of the discharging pipe is inclined downwards and is in threaded connection with a sealing cover 12, and the feeding pipe 4 and the discharging pipe 5 are located on two opposite sides of the drying chamber 102 respectively. A screen 13 is arranged between the air inlet chamber 101 and the drying chamber 102, a filter cloth 10 is arranged between the drying chamber 102 and the air outlet chamber 103, the filter cloth 10 is arranged in an arc shape, the outer arc surface faces the air outlet chamber 103, and the screen 13 and the filter cloth 10 are both fixed on the circumferential inner wall of the tank body.
Referring to fig. 2-3, a driving mechanism, a stirring mechanism and a beating mechanism are arranged in the tank body. The driving mechanism is used for driving the stirring mechanism to stir the materials in the drying chamber 102 and for driving the beating mechanism to beat the filter cloth 10. Preferably, the drive mechanism includes a motor 61 and a spindle 62. The motor 61 is positioned in the air inlet chamber 101 and is installed at the center of the bottom of the screen 13, the main shaft 62 is vertically arranged, the lower end of the main shaft is connected with an output shaft of the motor 61, and the upper end of the main shaft penetrates through the screen 13 and the filter cloth 10 in sequence and is inserted into the top of the air outlet chamber 103. The stirring mechanism comprises a support cross bar 71 and a support vertical bar 72. The supporting cross bar 71 and the supporting vertical bar 72 are both located in the drying chamber 102, one end of the supporting cross bar 71 is fixed on the surface of the main shaft 62, and the other end extends towards the direction close to the side wall of the drying chamber 102. Support montant 72 one end and fix on supporting horizontal pole 71 surface, the other end outwards extends to supporting horizontal pole 71 radial direction, for playing better stirring effect, specifically, supports montant 72 and is provided with a plurality ofly along supporting horizontal pole 71 axial direction equidistance.
Referring to fig. 2-3, a buffer mechanism is disposed in the air outlet chamber 103, the buffer mechanism is connected between the filter cloth 10 and the top of the air outlet chamber 103, and the flapping mechanism is used for flapping the filter cloth 10 up and down to make the material adhered to the surface of the filter cloth 10 enter the drying chamber 102. Preferably, the tapping mechanism includes a worm 81, a worm wheel 82, a rotation shaft 83, and a cam 84. The worm 81, the worm wheel 82, the rotating shaft 83 and the cam 84 are all positioned in the air outlet chamber 103, the worm 81 is arranged on the main shaft 62, and the worm wheel 82 is positioned on one side of the worm 81 and meshed with the worm 81. Two ends of the rotating shaft 83 are respectively inserted into two opposite sides of the inside of the air outlet chamber 103, the worm gear 82 and the cam 84 are both fixed on the rotating shaft 83, and the circumferential surface of the cam 84 is in contact with the top surface of the filter cloth 10. The worm 81 is provided with a worm wheel 82, a rotation shaft 83, and a cam 84 on opposite sides in the radial direction. The two buffer mechanisms are symmetrically arranged on two opposite sides of the worm 81 in the radial direction. The buffer mechanism comprises a support rod 91 and a spring 92, the lower end of the support rod 91 is fixed with the filter cloth 10, the upper end of the support rod is connected with the spring 92, the lower end of the spring 92 is fixed with the support rod 91, and the upper end of the spring is fixed with the top of the air outlet chamber 103.
In the technical scheme, the traditional boiling dryer adopts a split structure, namely, a feed box for drying can slide out of a tank body to feed and discharge materials, the design not only increases the operation difficulty and improves the work load of workers, but also has errors easily after the feed box is pushed in, so that the feed box is poor in connection sealing performance, and the phenomena of air leakage and material leakage are easily caused, thereby providing the integrated boiling dryer. The material business turn over is realized through inlet pipe 4, discharging pipe 5, and during the drying, motor 61 starts to make main shaft 62 drive support horizontal pole 71, support montant 72, worm 81 and rotate. Hot air enters the air inlet chamber 101 through the hot air outlet, then enters the drying chamber 102 through the screen 13 for material drying, finally enters the air outlet chamber 103 through the filter cloth 10, and finally is discharged through the air outlet 3. Support horizontal pole 71, when support montant 72 rotates around main shaft 62, support horizontal pole 71, support montant 72 can play better stirring effect, so that the material fully contacts with hot-blast, improve drying efficiency and drying quality, when worm 81 rotates, worm wheel 82 will drive cam 84, pivot 83 rotates, because cam 84 circumference face and filter cloth 10 top surface contact, therefore when cam 84 rotates, under cam 84, spring 92 effect, filter cloth 10 will shake from top to bottom, thereby can shake the material of adhesion at filter cloth 10 internal surface and fall, reduce material loss and filter cloth 10 and block up, and is simple and convenient to use.
Example 2: the difference between the hydrotalcite chewable tablet and the preparation method thereof in the embodiment 1 is that every 500mg of hydrotalcite is mixed with the following components in the auxiliary materials: 300mg of mannitol, 80mg of corn starch, 0.2mg of saccharin sodium, 30mg of carboxymethyl starch sodium, 500mg of purified water, 1mg of powdered mint essence and 2mg of magnesium stearate. The particle size of the hydrotalcite is 110 μm.
The preparation method of the hydrotalcite chewable tablet is shown in figure 1 and comprises the following steps:
s1, pretreatment of auxiliary materials
Treating mannitol with a swing type pulverizer, sieving with a 60-mesh sieve, treating saccharin sodium with a pulverizer, and sieving with a 80-mesh sieve for later use.
S2, weighing raw materials
According to the mixture ratio of the raw materials in the hydrotalcite chewable tablet, hydrotalcite, mannitol, corn starch, saccharin sodium, carboxymethyl starch sodium, purified water, powdered mint essence and magnesium stearate are weighed.
S3 pulp preparation
Putting 26.4mg of the weighed corn starch into a stainless steel barrel, adding purified water with twice amount of the corn starch, uniformly dispersing, transferring into a pulping pot, adding purified water with twice amount into the stainless steel barrel, washing, transferring into the pulping pot, repeating the operation twice, adding the rest purified water, uniformly stirring, boiling, and keeping boiling for 3 min; stirring and cooling to 60 ℃ to obtain 5% starch slurry, wherein the starch slurry is used as an adhesive.
S4, mixing and granulating
Putting the prepared aluminum magnesium carbonate, mannitol, the rest corn starch, saccharin sodium and 15mg of carboxymethyl starch sodium into a wet granulating machine, and mixing for 5min at a stirring speed of 70 rpm; adding starch slurry, granulating, sieving with square mesh sieve, and discharging to obtain wet granule.
S5, drying
Drying the wet granules obtained in the step S4 in an integrated boiling dryer to obtain dry granules with the moisture content of less than 4%;
preferably, the wet granules obtained in the step S4 are placed in an integrated fluidized bed dryer, and the air inlet temperature is 80 ℃, and the fan frequency is 30HZ, so that the wet granules are dried until the temperature of the wet granules reaches 60 ℃; stopping heating, measuring the moisture content of the wet granules, and restarting the integrated boiling dryer for drying if the moisture content does not meet the requirement until dry granules with the moisture content of less than 4% are obtained.
S6, straightening granules
The dry granules obtained in step S5 were granulated by a granulator with a round screen of Φ 1.2mm at a granulation rotation speed of 700 ± 50 rpm.
S7 Total mixing
And (3) putting the powdered mint essence, the residual carboxymethyl starch sodium and the whole dried granules into a mixer, mixing for 10min at the rotating speed of 5rpm, adding weighed magnesium stearate, continuously mixing for 3min at the rotating speed of 5rpm, and discharging.
S8, tabletting
And (3) putting the total mixed materials into an S250smart tablet press for tabletting, and selecting an inclined flat punching die with the specification of phi 16mm to obtain the hydrotalcite chewable tablet.
S9, packaging
And (5) packaging the hydrotalcite chewable tablets obtained in the step S8 to obtain the finished product.
Example 3: the difference between the hydrotalcite chewable tablet and the preparation method thereof in the embodiment 1 is that every 500mg of hydrotalcite is mixed with the following components in the auxiliary materials: 400mg of mannitol, 130mg of corn starch, 0.8mg of saccharin sodium, 50mg of carboxymethyl starch sodium, 600mg of purified water, 3mg of powdered mint essence and 15mg of magnesium stearate. The granularity of the hydrotalcite is 110 mu m.
The preparation method of the hydrotalcite chewable tablet is shown in figure 1 and comprises the following steps:
s1, pretreatment of auxiliary materials
Treating mannitol with a swing type pulverizer, sieving with a 60-mesh sieve, treating saccharin sodium with a pulverizer, and sieving with a 80-mesh sieve for later use.
S2, weighing raw materials
According to the mixture ratio of the raw materials in the hydrotalcite chewable tablet, hydrotalcite, mannitol, corn starch, saccharin sodium, carboxymethyl starch sodium, purified water, powdered mint essence and magnesium stearate are weighed.
S3 pulp preparation
Putting 32.5mg of the weighed corn starch into a stainless steel barrel, adding purified water with twice amount of the corn starch, uniformly dispersing, transferring into a pulping pot, adding purified water with twice amount into the stainless steel barrel, washing, transferring into the pulping pot, repeating the operation twice, adding the rest purified water, uniformly stirring, boiling, and keeping boiling for 3 min; stirring and cooling to 70 ℃ to obtain 5% starch slurry, wherein the starch slurry is used as an adhesive.
S4, mixing and granulating
Putting the prepared aluminum magnesium carbonate, mannitol, the rest corn starch, saccharin sodium and 25mg of carboxymethyl starch sodium into a wet granulating machine, and mixing for 5min at a stirring speed of 70 rpm; adding starch slurry, granulating, sieving with square mesh sieve, and discharging to obtain wet granule.
S5, drying
Drying the wet granules obtained in the step S4 in an integrated boiling dryer to obtain dry granules with the moisture content of less than 4%;
preferably, the wet granules obtained in the step S4 are placed in an integrated fluidized bed dryer, and the wet granules are dried at the air inlet temperature of 85 ℃ and the fan frequency of 40HZ until the temperature of the wet granules reaches 60 ℃; stopping heating, measuring the moisture content of the wet granules, and restarting the integrated boiling dryer for drying if the moisture content does not meet the requirement until dry granules with the moisture content of less than 4% are obtained.
S6, granulating
The dry granules obtained in step S5 were granulated by a granulator having a diameter of 1.2mm circular sieve at a granulation speed of 700 ± 50 rpm.
S7 Total mixing
And (3) putting the powdered mint essence, the residual carboxymethyl starch sodium and the whole dried granules into a mixer, mixing for 10min at the rotating speed of 5rpm, adding weighed magnesium stearate, continuously mixing for 3min at the rotating speed of 5rpm, and discharging.
S8, tabletting
And (3) putting the total mixed materials into an S250smart tablet press for tabletting, and selecting an inclined flat punching die with the specification of phi 16mm to obtain the hydrotalcite chewable tablet.
S9, packaging
And (5) packaging the hydrotalcite chewable tablets obtained in the step S8 to obtain the product.
The above description is only a preferred embodiment of the present invention, and the scope of the present invention is not limited to the above embodiments, and all technical solutions that belong to the idea of the present invention belong to the scope of the present invention. It should be noted that several improvements and modifications within the scope of the present invention can be made by those skilled in the art without departing from the principle of the present invention, and these improvements and modifications should also be construed as the scope of the present invention.

Claims (10)

1. A hydrotalcite chewable tablet is characterized in that: the compound preservative is prepared from hydrotalcite and auxiliary materials, wherein the auxiliary materials comprise mannitol, corn starch, saccharin sodium, carboxymethyl starch sodium, purified water, powdered mint essence and magnesium stearate;
wherein, every 500mg of the hydrotalcite is prepared from the following components in percentage by weight: 400mg of mannitol, 80-130mg of corn starch, 0.2-0.8mg of saccharin sodium, 30-50mg of carboxymethyl starch sodium, 500mg of purified water, 1-3mg of powdered mint essence and 5-15mg of magnesium stearate.
2. The hydrotalcite chewable tablet of claim 1, wherein: the particle size of the hydrotalcite is less than 120 μm.
3. A preparation method of a hydrotalcite chewable tablet is characterized in that: the method comprises the following steps:
s1, pretreatment of auxiliary materials
Treating mannitol with a swing machine, sieving with a 60-mesh sieve, treating saccharin sodium with a pulverizer, and sieving with a 80-mesh sieve for later use;
s2, weighing raw materials
Weighing the hydrotalcite, mannitol, corn starch, saccharin sodium, carboxymethyl starch sodium, purified water, powdered mint essence and magnesium stearate according to the proportion of the raw materials in the hydrotalcite chewable tablet of any one of claims 1 to 2;
s3, preparing slurry
Putting the weighed corn starch 1/4-1/3 into a stainless steel barrel, adding purified water with twice amount of the corn starch, uniformly dispersing, transferring into a slurry melting pot, adding purified water with twice amount of the stainless steel barrel, washing, transferring into the slurry melting pot, repeating the operation twice, adding the rest amount of the purified water, uniformly stirring, boiling, and keeping boiling for 3 min; keeping stirring and cooling to 60-70 ℃ to obtain starch slurry;
s4, mixing and granulating
Putting the prepared aluminum magnesium carbonate, mannitol, residual corn starch, saccharin sodium and sodium carboxymethyl starch 1/2 into a wet granulating machine, and mixing for 5min at stirring speed of 70 rpm; adding the starch slurry to prepare granules, and then finishing the granules through a square-hole sieve to obtain wet granules;
s5, drying
Drying the wet granules obtained in the step S4 in an integrated boiling dryer to obtain dry granules with the moisture content of less than 4%;
s6, straightening granules
Straightening the dry granules in the step S5 by a straightening granulator of a round-hole sieve;
s7 Total mixing
Putting the powdered mint essence, the residual carboxymethyl starch sodium and the whole dry granules into a mixer, mixing for 10min, adding weighed magnesium stearate, and continuously mixing for 3min at the rotating speed of 5 rpm;
s8, tabletting
Putting the total mixed materials into a tablet machine for tabletting to obtain the hydrotalcite chewable tablets;
s9, packaging
And (5) packaging the hydrotalcite chewable tablets obtained in the step S8 to obtain the finished product.
4. The method for preparing the hydrotalcite chewable tablet according to claim 3, wherein the step of preparing the hydrotalcite chewable tablet comprises the following steps: in step S5, the wet granules obtained in step S4 are placed in an integrated boiling dryer, and the wet granules are dried at the air inlet temperature of 80-85 ℃ and the fan frequency of 30-40HZ until the temperature of the wet granules reaches 60 ℃; stopping heating, measuring the moisture content of the wet granules, and restarting the integrated boiling dryer for drying if the moisture content does not meet the requirement until dry granules with the moisture content of less than 4% are obtained.
5. The method for preparing the hydrotalcite chewable tablet according to claim 4, wherein the step of preparing the hydrotalcite chewable tablet comprises the following steps: the integrated boiling dryer comprises a tank body, the tank body sequentially comprises an air inlet chamber (101), a drying chamber (102) and an air outlet chamber (103) from bottom to top, a hot air inlet (2) is formed in the side of the air inlet chamber (101), an air outlet (3) is formed in the side of the air outlet chamber (103), and a feeding pipe (4) and a discharging pipe (5) for feeding and discharging materials are arranged in the side of the drying chamber (102);
be provided with screen cloth (13) between intake chamber (101), drying chamber (102), be provided with filter cloth (10) between drying chamber (102), the air-out room (103), jar internal actuating mechanism, rabbling mechanism and the patting mechanism of being provided with, actuating mechanism is used for the drive the rabbling mechanism stirring material in drying chamber (102) just is used for the drive patting mechanism is right filter cloth (10) are patted.
6. The method for preparing the hydrotalcite chewable tablet according to claim 5, wherein the step of: the driving mechanism comprises a motor (61) and a main shaft (62);
the motor (61) is positioned in the air inlet chamber (101) and is arranged at the bottom of the screen (13), the lower end of the main shaft (62) is connected with an output shaft of the motor (61), and the upper end of the main shaft penetrates through the screen (13) and the filter cloth (10) in sequence and is inserted into the top in the air outlet chamber (103).
7. The method for preparing hydrotalcite chewable tablet according to claim 6, wherein the chewable tablet comprises: the stirring mechanism comprises a supporting cross rod (71) and a supporting vertical rod (72);
support horizontal pole (71) with support montant (72) and all be located drying chamber (102), support horizontal pole (71) one end is fixed main shaft (62) surface, the other end to being close to drying chamber (102) lateral wall direction extends, support montant (72) one end is fixed support horizontal pole (71) surface, the other end to support horizontal pole (71) radial direction outwards extends.
8. The method for preparing the hydrotalcite chewable tablet according to claim 6, wherein the step of: a buffer mechanism is arranged in the air outlet chamber (103), the buffer mechanism is connected between the filter cloth (10) and the top of the air outlet chamber (103), and the beating mechanism is used for beating the filter cloth (10) up and down so as to enable materials adhered to the surface of the filter cloth (10) to enter the drying chamber (102).
9. The method for preparing hydrotalcite chewable tablet according to claim 8, wherein the chewable tablet comprises: the flapping mechanism comprises a worm (81), a worm wheel (82), a rotating shaft (83) and a cam (84);
the filter cloth is characterized in that the worm (81), the worm wheel (82), the rotating shaft (83) and the cam (84) are located in the air outlet chamber (103), the worm (81) is arranged on the main shaft (62), the worm wheel (82) is located on one side of the worm (81) and meshed with the worm (81), two ends of the rotating shaft (83) are respectively inserted into two opposite sides of the interior of the air outlet chamber (103), the worm wheel (82) and the cam (84) are fixed on the rotating shaft (83), and the circumferential surface of the cam (84) is in contact with the top surface of the filter cloth (10).
10. The method for preparing the hydrotalcite chewable tablet according to claim 8, wherein the step of: the filter cloth (10) is arranged in an arc shape, the outer arc surface faces the air outlet chamber (103), the buffer mechanism comprises a support rod (91) and a spring (92), the lower end of the support rod (91) is fixed with the filter cloth (10), the upper end of the support rod is connected with the spring (92), the lower end of the spring (92) is fixed with the support rod (91), and the upper end of the spring is fixed with the inner top of the air outlet chamber (103).
CN202210378555.4A 2022-04-12 2022-04-12 Aluminum magnesium carbonate chewable tablet and preparation method thereof Active CN114699427B (en)

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