CN116211704A - Dry granulating method and prepared sodium Igacross tablets - Google Patents
Dry granulating method and prepared sodium Igacross tablets Download PDFInfo
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- CN116211704A CN116211704A CN202310315794.XA CN202310315794A CN116211704A CN 116211704 A CN116211704 A CN 116211704A CN 202310315794 A CN202310315794 A CN 202310315794A CN 116211704 A CN116211704 A CN 116211704A
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- shell
- feeding mechanism
- dry granulation
- machine body
- rigid coupling
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 title claims abstract description 42
- 238000000034 method Methods 0.000 title claims abstract description 42
- 229910052708 sodium Inorganic materials 0.000 title claims abstract description 42
- 239000011734 sodium Substances 0.000 title claims abstract description 42
- 230000007246 mechanism Effects 0.000 claims abstract description 67
- 239000000463 material Substances 0.000 claims abstract description 52
- 230000001360 synchronised effect Effects 0.000 claims abstract description 44
- 238000007906 compression Methods 0.000 claims abstract description 24
- 230000006835 compression Effects 0.000 claims abstract description 24
- 238000002360 preparation method Methods 0.000 claims abstract description 16
- 238000001125 extrusion Methods 0.000 claims abstract description 14
- 239000008187 granular material Substances 0.000 claims abstract description 13
- 239000002245 particle Substances 0.000 claims abstract description 10
- 238000007873 sieving Methods 0.000 claims abstract description 10
- 230000005540 biological transmission Effects 0.000 claims abstract description 9
- 239000000203 mixture Substances 0.000 claims abstract description 5
- 238000007908 dry granulation Methods 0.000 claims description 35
- 238000002156 mixing Methods 0.000 claims description 33
- 230000008878 coupling Effects 0.000 claims description 21
- 238000010168 coupling process Methods 0.000 claims description 21
- 238000005859 coupling reaction Methods 0.000 claims description 21
- 235000021355 Stearic acid Nutrition 0.000 claims description 20
- 238000000576 coating method Methods 0.000 claims description 20
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 20
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 20
- 239000001508 potassium citrate Substances 0.000 claims description 20
- 229960002635 potassium citrate Drugs 0.000 claims description 20
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 claims description 20
- 235000011082 potassium citrates Nutrition 0.000 claims description 20
- 239000008117 stearic acid Substances 0.000 claims description 20
- 238000003825 pressing Methods 0.000 claims description 16
- 239000011248 coating agent Substances 0.000 claims description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 15
- 239000007888 film coating Substances 0.000 claims description 11
- 238000009501 film coating Methods 0.000 claims description 11
- 239000011812 mixed powder Substances 0.000 claims description 11
- 239000000843 powder Substances 0.000 claims description 11
- 229920002472 Starch Polymers 0.000 claims description 10
- 238000005520 cutting process Methods 0.000 claims description 10
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 10
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 10
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 10
- 229960003943 hypromellose Drugs 0.000 claims description 10
- 239000004033 plastic Substances 0.000 claims description 10
- 229920003023 plastic Polymers 0.000 claims description 10
- 230000008569 process Effects 0.000 claims description 10
- 239000008213 purified water Substances 0.000 claims description 10
- 239000002994 raw material Substances 0.000 claims description 10
- 239000008107 starch Substances 0.000 claims description 10
- 235000019698 starch Nutrition 0.000 claims description 10
- 238000004090 dissolution Methods 0.000 claims description 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 5
- 239000013543 active substance Substances 0.000 claims description 5
- 239000000853 adhesive Substances 0.000 claims description 5
- 230000001070 adhesive effect Effects 0.000 claims description 5
- 230000032683 aging Effects 0.000 claims description 5
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 5
- 229910052782 aluminium Inorganic materials 0.000 claims description 5
- 238000000889 atomisation Methods 0.000 claims description 5
- 239000000945 filler Substances 0.000 claims description 5
- 238000011049 filling Methods 0.000 claims description 5
- 239000011888 foil Substances 0.000 claims description 5
- 230000002496 gastric effect Effects 0.000 claims description 5
- 238000000227 grinding Methods 0.000 claims description 5
- 239000000314 lubricant Substances 0.000 claims description 5
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 5
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 5
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 5
- 238000000465 moulding Methods 0.000 claims description 5
- 238000004806 packaging method and process Methods 0.000 claims description 5
- 238000012856 packing Methods 0.000 claims description 5
- 229920000915 polyvinyl chloride Polymers 0.000 claims description 5
- 239000004800 polyvinyl chloride Substances 0.000 claims description 5
- 238000007789 sealing Methods 0.000 claims description 5
- 239000007787 solid Substances 0.000 claims description 5
- 239000002904 solvent Substances 0.000 claims description 5
- 239000003381 stabilizer Substances 0.000 claims description 5
- 229960004274 stearic acid Drugs 0.000 claims description 5
- 230000004584 weight gain Effects 0.000 claims description 5
- 235000019786 weight gain Nutrition 0.000 claims description 5
- 235000013339 cereals Nutrition 0.000 claims 4
- 235000020985 whole grains Nutrition 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 3
- 230000002457 bidirectional effect Effects 0.000 description 7
- 230000000903 blocking effect Effects 0.000 description 6
- 230000001276 controlling effect Effects 0.000 description 6
- 238000005453 pelletization Methods 0.000 description 4
- 230000001105 regulatory effect Effects 0.000 description 4
- 238000004140 cleaning Methods 0.000 description 3
- 201000009273 Endometriosis Diseases 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 238000004513 sizing Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Images
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B30—PRESSES
- B30B—PRESSES IN GENERAL
- B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
- B30B11/18—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using profiled rollers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
- B01J2/20—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by expressing the material, e.g. through sieves and fragmenting the extruded length
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
- B01J2/22—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by pressing in moulds or between rollers
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B02—CRUSHING, PULVERISING, OR DISINTEGRATING; PREPARATORY TREATMENT OF GRAIN FOR MILLING
- B02C—CRUSHING, PULVERISING, OR DISINTEGRATING IN GENERAL; MILLING GRAIN
- B02C13/00—Disintegrating by mills having rotary beater elements ; Hammer mills
- B02C13/02—Disintegrating by mills having rotary beater elements ; Hammer mills with horizontal rotor shaft
- B02C13/06—Disintegrating by mills having rotary beater elements ; Hammer mills with horizontal rotor shaft with beaters rigidly connected to the rotor
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B02—CRUSHING, PULVERISING, OR DISINTEGRATING; PREPARATORY TREATMENT OF GRAIN FOR MILLING
- B02C—CRUSHING, PULVERISING, OR DISINTEGRATING IN GENERAL; MILLING GRAIN
- B02C4/00—Crushing or disintegrating by roller mills
- B02C4/10—Crushing or disintegrating by roller mills with a roller co-operating with a stationary member
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B30—PRESSES
- B30B—PRESSES IN GENERAL
- B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
- B30B15/0082—Dust eliminating means; Mould or press ram cleaning means
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- Y—GENERAL 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
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
- Y02E50/00—Technologies for the production of fuel of non-fossil origin
- Y02E50/30—Fuel from waste, e.g. synthetic alcohol or diesel
Abstract
The invention belongs to the technical field of medicine preparation, in particular to a dry granulating method and a prepared sodium argatrovix tablet, wherein the dry granulating method comprises the following steps: controlling the electric push rod to push the movable main shaft to slide along the adjusting notch, and controlling the gap between the two compression rollers; meanwhile, the motor is controlled to drive the synchronous belt to tighten towards two sides or stretch towards the middle part, and the tightness degree of the synchronous belt is adjusted; the crushed and ground materials are added into the hopper, the materials are conveyed between two compression rollers by a spiral conveying mechanism, at the moment, a power unit in the machine body drives a fixed main shaft to rotate, and the fixed main shaft is driven to rotate through the transmission of a synchronous wheel and a synchronous belt, so that the two compression rollers rotate, and the powdery materials are pressed into sheets; the pressed slices fall onto a pre-crushing assembly and are crushed into slices with different sizes by the pre-crushing assembly; then the mixture falls into a granulating mechanism, and granules meeting the specification are prepared through extrusion, sieving and granulating; the acceptable particles fall from the bottom of the housing.
Description
Technical Field
The invention belongs to the technical field of medicine preparation, and particularly relates to a dry granulation method and an Igacross sodium tablet prepared by the dry granulation method.
Background
The alagolica sodium tablet is used for treating moderate to severe pain caused by endometriosis; the existing Alagox sodium tablet is prepared by adopting a dry granulation technology, solves the problem of high hygroscopicity, has a dissolution curve similar to that of an original reference preparation, and achieves bioequivalence; the content uniformity is good, the analysis method capable of effectively monitoring the enantiomer and related substances is provided, and the medication compliance of patients is good.
The dry granulation method is a method of uniformly mixing the powder of the materials and the auxiliary materials, compressing the mixture into a large sheet or plate shape, and crushing and sieving the mixture into particles with the required size; the method uses compression force to generate binding force between molecules, and the preparation method comprises a tabletting method and a rolling method; the existing dry granulation process flow mainly comprises the steps of crushing, sieving, mixing, briquetting, crushing, granulating, mixing and tabletting.
The dry granulating method mainly uses a dry granulator to granulate, when the powder is pressed into granules, a pair of compression rollers are needed to compress the powder into sheets, and the pair of compression rollers of the existing dry granulator directly use gear meshing transmission, so that the gap between the pair of compression rollers is fixed, the adjustment and the change cannot be performed, and only sheets with the same thickness specification can be manufactured, thereby reducing the application range of the dry granulator.
For this purpose, the invention provides a dry granulation method and a prepared sodium alagolide tablet.
Disclosure of Invention
In order to overcome the deficiencies of the prior art, at least one technical problem presented in the background art is solved.
The technical scheme adopted for solving the technical problems is as follows: the invention relates to a dry granulating method, which comprises the following steps:
s01: debugging the dry granulating machine according to the granulating size requirement, controlling the electric push rod to push the movable main shaft to slide along the regulating notch, and controlling the gap between the two compression rollers;
s02: meanwhile, the motor is controlled to drive the sliding blocks at two sides to slide along the slideway, the synchronous belt is driven to tighten towards two sides or stretch towards the middle part, and the tightness degree of the synchronous belt is regulated;
s03: the crushed and ground materials are added into the hopper, the materials are conveyed between two compression rollers by a spiral conveying mechanism, at the moment, a power unit in the machine body drives a fixed main shaft to rotate, and the fixed main shaft is driven to rotate through the transmission of a synchronous wheel and a synchronous belt, so that the two compression rollers rotate, and the powdery materials are pressed into sheets;
s04: the pressed slices fall onto a pre-crushing assembly and are crushed into slices with different sizes by the pre-crushing assembly; then the mixture falls into a granulating mechanism, and granules meeting the specification are prepared through extrusion, sieving and granulating;
s05: the acceptable particles fall from the bottom of the housing.
Preferably, the dry granulator comprises a machine body, a granulating unit is fixedly connected to one side outer wall of the machine body, a power unit is arranged in the machine body and provides driving force for the granulating unit, the granulating unit comprises a shell, the outer wall of one side of the machine body is fixedly connected with the shell, an extrusion mechanism is arranged on the top side of the inside of the shell and comprises a fixed main shaft, the fixed main shaft is rotatably arranged at the top of one side, which is close to the machine body, of the shell, one end of the fixed main shaft penetrates through the outer wall of the machine body and is connected with the power unit, an adjusting notch is formed in the top of one side, which is close to the machine body, of the shell, a movable main shaft is slidably arranged in the adjusting notch, the outer wall of the movable main shaft is in rotary fit with the adjusting notch, a compression roller is fixedly connected to the outer ring of one end, which is located in the shell, of the fixed main shaft and the movable main shaft, which is close to the middle of one end of the machine body, of the outer ring of the fixed main shaft is fixedly connected with a synchronous wheel, and the synchronous wheels are provided with synchronous belts.
Preferably, a spiral feeding mechanism is fixedly connected to the top of one side of the shell, a hopper is fixedly connected to the top of one end of the spiral feeding mechanism, far away from the shell, and a discharge hole of the hopper is communicated with a feed inlet of the spiral feeding mechanism, the hopper is fixedly connected with the machine body, the discharge hole of the spiral feeding mechanism is connected between two compression rollers, a pre-crushing assembly is arranged on one side of the shell, far away from the spiral feeding mechanism, and a grain finishing mechanism is arranged at the bottom of the shell.
Preferably, the organism is close to one side top rigid coupling of shell and has electric putter, the middle part outer lane of moving the main shaft rotates and installs fixed cover, the inside of fixed cover rotates and installs the bearing, the top of fixed cover passes through the flange rigid coupling with electric putter's slide bar tip, the both sides of adjusting the notch all are provided with the slide rail, slide rail and shell rigid coupling, the inside slidable mounting of slide rail has the guide block, the middle part rigid coupling of guide block has the connecting rod, the connecting rod slides the side lug that runs through fixed cover, the side lug screw thread of fixed cover installs locking screw.
Preferably, one side rigid coupling that the shell is close to the organism has the slide, the slide is located between fixed spindle and the main shaft that moves, the inside rotation of slide is installed bi-directional screw, the one end of slide is provided with the motor, the outer wall rigid coupling of motor and shell, the pivot and the tip rigid coupling of bi-directional screw of motor, the inside both ends of slide all slidable mounting have the slider, bi-directional screw runs through the slider, and bi-directional screw and slider screw-thread fit, the fixed slot has all been seted up to the both sides of slider, the inside slidable mounting of fixed slot has splint, and through the bolt rigid coupling between splint and the slider, two with hold-in range sliding fit between the splint.
Preferably, one side of the fixed sleeve, which is close to the shell, is fixedly connected with a blocking plate, one side of the blocking plate, which is close to the shell, is fixedly connected with a rubber pad, an inner ring of the rubber pad is in running fit with an outer ring of the movable main shaft, and a plurality of rubber lugs are fixedly connected around the inner ring of the rubber pad.
Preferably, the discharge hole of the spiral feeding mechanism is fixedly connected with a supporting plate, the supporting plate is sleeved on the outer ring of the middle of the two compression rollers, two sides of the supporting plate are fixedly connected with baffle plates, and one surface, close to the baffle plates, of the baffle plates is in sliding fit with the side walls of the middle of the two compression rollers.
Preferably, the top and the bottom of the discharge hole of the spiral feeding mechanism are provided with scrapers, two sides of each scraper are slidably provided with long screws, the long screws penetrate through the scrapers in a sliding mode, the end portions of the long screws are in threaded connection with the outer wall of the discharge hole of the spiral feeding mechanism, the edge of each scraper is slidably matched with the outer wall of the compression roller, a spring is sleeved on the outer ring of each long screw, and the spring is located between each scraper and the outer wall of the discharge hole of the spiral feeding mechanism.
The sodium argatrovix tablet is prepared by adopting the dry granulation method, and consists of the following raw materials in parts by weight:
the sodium elvagogram is an active substance, the soluble starch is a filler, the hypromellose is an adhesive, the stearic acid is a lubricant, the potassium citrate is a stabilizer, the medicinal film coating premix auxiliary material is a coating material, the purified water is a solvent, the purified water is removed in the coating process, the sheet preparation is completed, and the water content in the product is extremely low.
Preferably, the preparation method of the sodium argatrovix tablet comprises the following steps:
s11: crushing auxiliary material potassium citrate for 2 times, and pre-treating the crushed potassium citrate by a screen with the diameter of 1.0 mm; and the grinding rotating speed is 1000-5000 rpm;
s12: adding auxiliary materials of soluble starch, hypromellose, stearic acid and raw material of Alagox sodium, premixing, and sieving with a screen with phi of 0.8-3.0 mm to obtain mixed powder; the rotation speed of the mixing is 5-10 rpm; mixing time is 3-6 min;
s13: adding stearic acid into the mixed powder, mixing, and performing dry granulation to obtain dry granulation granules; the rotating speed of the spiral feeding mechanism is 10-50 rpm; the rotating speed of the press roller is 10-50 rpm; the pressure of the press roller is 0-30 bar; the gap of the compression roller is 1-2 mm; the thickness of the extrusion sheet is 1-3 mm; the aperture of the screen is 1.5mm; the rotating speed of the grain finishing mechanism is 10-50 rpm;
s14: adding potassium citrate, stearic acid and microcrystalline cellulose to perform total mixing to obtain total mixed particles with excellent content uniformity and good fluidity; mixing speed 10rpm; mixing time is 5min;
s15: tabletting to obtain the sodium alagolide tablet with small tablet weight difference, quick disintegration aging and good formability; tabletting speed is 40-90 kilo tablets/hour; the filling depth is 3.0-9.9 mm; the thickness of the main pressing sheet is 1.0-3.5 mm; the thickness of the pre-pressed sheet is 1.3-4.55 mm; the rotation speed of the powder feeder is 50-90 rpm;
s16: coating the tablet with medicinal film coating premix auxiliary material gastric dissolution type to obtain a uniform film coated sodium alagolicum tablet; the air inlet is 500-3500 m 3 The method comprises the steps of carrying out a first treatment on the surface of the The air inlet temperature is 40-60 ℃; the temperature of the slice bed is 20-35 ℃; the atomization pressure is 0-2 bar; coating weight gain is 1% -3%;
s17: adopting polyvinyl chloride solid medicinal hard sheets and medicinal aluminum foils to carry out aluminum-plastic packaging to obtain an aluminum-plastic plate; the molding temperature is 60-110 ℃; the heat sealing temperature is 80-160 ℃; cutting speed is 40-180 cutting/min;
s18: and (5) externally packing to obtain a finished product and warehousing.
The beneficial effects of the invention are as follows:
1. according to the dry granulating method and the prepared sodium argyi la goke tablet, a fixed main shaft, a movable main shaft, a press roller, a synchronous wheel, a synchronous belt and an electric push rod are arranged; according to the size requirement of pelletization, the dry-method pelletization machine is debugged, the electric push rod is controlled to push the movable main shaft to slide along the adjusting notch, and the gap between the two compression rollers is controlled, so that the thickness of the sheet during pressing is controlled, sheets with different thickness specifications are manufactured conveniently, and the application range of the dry-method pelletization machine is improved.
2. According to the dry granulating method and the prepared sodium argatrovix tablet, the scraper, the long screw rod and the spring are arranged; the elastic force of the spring pushes the scraper to slide along the long screw rod, so that the edge of the scraper always clings to the outer wall of the press roller, powder stained on the surface of the press roller is scraped off, the cleaning degree of the surface of the press roller is improved, and the efficiency and quality of pressing materials into sheets are improved.
Drawings
The invention is further described below with reference to the accompanying drawings.
FIG. 1 is a perspective view of the present invention;
FIG. 2 is a perspective view of the pelletization unit of the present invention;
FIG. 3 is a first perspective view of the compression mechanism of the present invention;
FIG. 4 is a second perspective view of the compression mechanism of the present invention;
FIG. 5 is an exploded view of the extrusion mechanism of the present invention;
FIG. 6 is a perspective view of a barrier panel of the present invention;
FIG. 7 is a perspective view of the screw feeding mechanism of the present invention;
FIG. 8 is an enlarged view of a portion of FIG. 7 at A;
FIG. 9 is a flow chart of the dry granulation process of the present invention;
fig. 10 is a flowchart of a preparation method of the sodium alagolicum tablet according to the present invention;
in the figure: 1. a body; 2. a housing; 3. a main shaft is fixed; 4. adjusting the notch; 5. a main shaft; 6. a press roller; 7. a synchronizing wheel; 8. a synchronous belt; 9. a spiral feeding mechanism; 10. a hopper; 11. a pre-crushing assembly; 12. a grain finishing mechanism; 13. an electric push rod; 14. a fixed sleeve; 15. a slide rail; 16. a guide block; 17. a connecting rod; 18. a slideway; 19. a bidirectional screw; 20. a motor; 21. a slide block; 22. a fixing groove; 23. a clamping plate; 24. a blocking plate; 25. a rubber pad; 26. rubber lugs; 27. a support plate; 28. a baffle; 29. a scraper; 30. a long screw; 31. and (3) a spring.
Detailed Description
The invention is further described in connection with the following detailed description in order to make the technical means, the creation characteristics, the achievement of the purpose and the effect of the invention easy to understand.
As shown in fig. 9, a dry granulation method according to an embodiment of the present invention includes the steps of:
s01: debugging the dry granulating machine according to the granulating size requirement, controlling the electric push rod 13 to push the movable main shaft 5 to slide along the regulating notch 4, and controlling the gap between the two pressing rollers 6;
s02: meanwhile, the control motor 20 drives the sliding blocks 21 at two sides to slide along the slideway 18, drives the synchronous belt 8 to tighten towards two sides or stretch towards the middle part, and adjusts the tightness degree of the synchronous belt 8;
s03: the crushed and ground materials are added into the hopper 10, the materials are conveyed between the two press rolls 6 by the spiral conveying mechanism 9, at the moment, the power unit in the machine body 1 drives the fixed main shaft 3 to rotate, and the movable main shaft 5 is driven to rotate through the transmission of the synchronous wheel 7 and the synchronous belt 8, so that the two press rolls 6 rotate, and the powdery materials are pressed into sheets;
s04: the pressed slices fall onto the pre-crushing assembly 11 and are crushed into slices with different sizes by the pre-crushing assembly 11; then falls into the granulating mechanism 12, and is extruded, sieved and granulated to prepare granules meeting the specification;
s05: the acceptable granules fall from the bottom of the housing 2.
As shown in fig. 1 to 5, the dry granulator comprises a machine body 1, a granulating unit is fixedly connected to the outer wall of one side of the machine body 1, a power unit is arranged in the machine body 1 and provides driving force for the granulating unit, the granulating unit comprises a shell 2, the outer wall of one side of the machine body 1 is fixedly connected with the shell 2, an extrusion mechanism is arranged on the top side of the interior of the shell 2, the extrusion mechanism comprises a fixed main shaft 3, the fixed main shaft 3 is rotatably arranged at the top of one side, close to the machine body 1, of the shell 2, one end of the fixed main shaft 3 penetrates through the outer wall of the machine body 1 and is connected with the power unit, an adjusting notch 4 is formed in the top of one side, close to the machine body 1, of the shell 2, a movable main shaft 5 is slidably arranged in the adjusting notch 4, the outer wall of the movable main shaft 5 is in rotary fit with the adjusting notch 4, a pressing roller 6 is fixedly connected to the outer ring of one end, close to the outer ring of the shell 2, of the fixed main shaft 3, and the outer ring 5, close to the machine body 1, of one end, of the machine body 7 is fixedly connected with a synchronous wheel 7, and the synchronous belt 8 is arranged on the two synchronous wheels 7; during operation, the dry granulator is debugged according to the size requirement of granulating, the electric push rod 13 is controlled to push the movable main shaft 5 to slide along the adjusting notch 4, and the gap between the two pressing rollers 6 is controlled, so that the thickness of the sheet during pressing is controlled, sheets with different thickness specifications are manufactured conveniently, and the application range of the dry granulator is improved.
As shown in fig. 1 to 2, a spiral feeding mechanism 9 is fixedly connected to the top of one side of the shell 2, a hopper 10 is fixedly connected to the top of one end, far away from the shell 2, of the spiral feeding mechanism 9, a discharge hole of the hopper 10 is communicated with a feed inlet of the spiral feeding mechanism 9, the hopper 10 is fixedly connected with the machine body 1, the discharge hole of the spiral feeding mechanism 9 is connected between two press rolls 6, a pre-crushing assembly 11 is arranged on one side, far away from the spiral feeding mechanism 9, of the interior of the shell 2, and a grain sizing mechanism 12 is arranged at the bottom of the interior of the shell 2; during operation, crushed and ground materials are added into the hopper 10, the materials are conveyed between the two press rolls 6 by the spiral feeding mechanism 9, at the moment, the power unit in the machine body 1 drives the fixed main shaft 3 to rotate, and the movable main shaft 5 is driven to rotate through the transmission of the synchronous wheel 7 and the synchronous belt 8, so that the two press rolls 6 rotate, and the powdery materials are pressed into sheets; the pressed slices fall onto the pre-crushing assembly 11 and are crushed into slices with different sizes by the pre-crushing assembly 11; then falls into the granulating mechanism 12, and is extruded, sieved and shaped to be prepared into granules meeting the specification, thereby completing dry granulation of mixed powder, improving the drying degree of the flakes and improving the manufacturing quality of the flakes.
As shown in fig. 2 to 5, an electric push rod 13 is fixedly connected to the top of one side of the machine body 1, which is close to the shell 2, a fixed sleeve 14 is rotatably installed on the outer ring of the middle part of the movable main shaft 5, a bearing is rotatably installed in the fixed sleeve 14, the top of the fixed sleeve 14 is fixedly connected with the end part of a sliding rod of the electric push rod 13 through a flange, sliding rails 15 are arranged on two sides of the adjusting notch 4, the sliding rails 15 are fixedly connected with the shell 2, a guide block 16 is slidably installed in the sliding rails 15, a connecting rod 17 is fixedly connected to the middle part of the guide block 16, the connecting rod 17 slidably penetrates through a side lug of the fixed sleeve 14, and a locking screw is threadedly installed on the side lug of the fixed sleeve 14; during operation, the electric push rod 13 is controlled to push the movable main shaft 5 to slide along the adjusting notch 4, and the guide block 16 is driven to slide along the slide rail 15 through the transmission of the connecting rod 17, so that the shaking of the movable main shaft 5 during movement is reduced, and the stability of the top press roller 6 during movement is improved.
As shown in fig. 3 to 5, a slide way 18 is fixedly connected to one side of the housing 2, which is close to the machine body 1, the slide way 18 is positioned between the fixed spindle 3 and the movable spindle 5, a bidirectional screw 19 is rotatably mounted in the slide way 18, a motor 20 is arranged at one end of the slide way 18, the motor 20 is fixedly connected with the outer wall of the housing 2, a rotating shaft of the motor 20 is fixedly connected with the end part of the bidirectional screw 19, a sliding block 21 is slidably mounted at two ends of the interior of the slide way 18, the bidirectional screw 19 penetrates through the sliding block 21, the bidirectional screw 19 is in threaded fit with the sliding block 21, fixing grooves 22 are formed at two sides of the sliding block 21, clamping plates 23 are slidably mounted in the fixing grooves 22, the clamping plates 23 are fixedly connected with the sliding block 21 through bolts, and the two clamping plates 23 are slidably fit with the synchronous belt 8; when the synchronous belt 8 is used, the tightness degree of the synchronous belt 8 is adjusted, the motor 20 drives the bidirectional screw rod 19 to rotate, the sliding blocks 21 at two sides are driven to slide along the slide ways 18, the clamping plates 23 at two sides are mobilized to move relatively, the synchronous belt 8 is driven to tighten at two sides or stretch towards the middle part, and the tightness degree of the synchronous belt 8 is adjusted, so that the probability that the synchronous belt 8 is separated from the outer ring of the synchronous wheel 7 is reduced, and the transmission stability and accuracy of the synchronous belt 8 and the synchronous wheel 7 are improved.
As shown in fig. 4 to 6, a blocking plate 24 is fixedly connected to one surface of the fixed sleeve 14, which is close to the housing 2, a rubber pad 25 is fixedly connected to one surface of the blocking plate 24, which is close to the housing 2, an inner ring of the rubber pad 25 is in running fit with an outer ring of the movable main shaft 5, and a plurality of rubber lugs 26 are fixedly connected around the inner ring of the rubber pad 25; during operation, when the movable main shaft 5 slides along the adjusting notch 4, the blocking plate 24 is driven to slide, so that the rubber pad 25 covers and blocks the adjusting notch 4, powdery materials are reduced from leaking out of the adjusting notch 4, and meanwhile, external impurities are prevented from entering the inner pollution materials of the shell 2.
As shown in fig. 4 to 5, a supporting plate 27 is fixedly connected to a discharge hole of the spiral feeding mechanism 9, the supporting plate 27 is sleeved on the outer rings of the middle parts of the two press rolls 6, baffle plates 28 are fixedly connected to two sides of the supporting plate 27, and one surface, close to the two baffle plates 28, is in sliding fit with the side walls of the middle parts of the two press rolls 6; the two sides of the two press rolls 6 are blocked by the supporting plate 27 and the baffle plate 28, so that materials conveyed by the spiral feeding mechanism 9 enter between the two press rolls 6, and the utilization rate of pressing the materials is improved.
As shown in fig. 7 to 8, the top and the bottom of the discharge hole of the spiral feeding mechanism 9 are respectively provided with a scraper 29, both sides of the scraper 29 are slidably provided with a long screw 30, the long screw 30 penetrates through the scraper 29 in a sliding manner, the end part of the long screw 30 is in threaded connection with the outer wall of the discharge hole of the spiral feeding mechanism 9, the edge of the scraper 29 is in sliding fit with the outer wall of the press roller 6, the outer ring of the long screw 30 is sleeved with a spring 31, and the spring 31 is positioned between the scraper 29 and the outer wall of the discharge hole of the spiral feeding mechanism 9; when the scraper is in operation, the scraper 29 is pushed by the elastic force of the spring 31 to slide along the long screw 30, so that the edge of the scraper 29 always contacts with the outer wall of the press roller 6, powder stained on the surface of the press roller 6 is scraped off, the cleaning degree of the surface of the press roller 6 is improved, and the efficiency and quality of pressing materials into sheets are improved.
The sodium argatrovix tablet is prepared by adopting the dry granulation method, and consists of the following raw materials in parts by weight:
the sodium elvagogram is an active substance, the soluble starch is a filler, the hypromellose is an adhesive, the stearic acid is a lubricant, the potassium citrate is a stabilizer, the medicinal film coating premix auxiliary material is a coating material, the purified water is a solvent, the purified water is removed in the coating process, the sheet preparation is completed, and the water content in the product is extremely low.
As shown in fig. 10, the preparation method of the alagolica sodium tablet comprises the following steps:
s11: crushing auxiliary material potassium citrate for 2 times, and pre-treating the crushed potassium citrate by a screen with the diameter of 1.0 mm; and the grinding rotating speed is 1000-5000 rpm;
s12: adding auxiliary materials of soluble starch, hypromellose, stearic acid and raw material of Alagox sodium, premixing, and sieving with a screen with phi of 0.8-3.0 mm to obtain mixed powder; the rotation speed of the mixing is 5-10 rpm; mixing time is 3-6 min;
s13: adding stearic acid into the mixed powder, mixing, and performing dry granulation to obtain dry granulation granules; the rotating speed of the spiral feeding mechanism 9 is 10-50 rpm; the rotating speed of the press roller 6 is 10-50 rpm; the pressure of the press roll 6 is 0 to 30bar; the gap of the press roll 6 is 1-2 mm; the thickness of the extrusion sheet is 1-3 mm; the aperture of the screen is 1.5mm; the rotating speed of the grain finishing mechanism 12 is 10-50 rpm;
s14: adding potassium citrate, stearic acid and microcrystalline cellulose to perform total mixing to obtain total mixed particles with excellent content uniformity and good fluidity; mixing speed 10rpm; mixing time is 5min;
s15: tabletting to obtain the sodium alagolide tablet with small tablet weight difference, quick disintegration aging and good formability; tabletting speed is 40-90 kilo tablets/hour; the filling depth is 3.0-9.9 mm; the thickness of the main pressing sheet is 1.0-3.5 mm; the thickness of the pre-pressed sheet is 1.3-4.55 mm; the rotation speed of the powder feeder is 50-90 rpm;
s16: coating the tablet with medicinal film coating premix auxiliary material gastric dissolution type to obtain a uniform film coated sodium alagolicum tablet; the air inlet is 500-3500 m 3 The method comprises the steps of carrying out a first treatment on the surface of the The air inlet temperature is 40-60 ℃; the temperature of the slice bed is 20-35 ℃; the atomization pressure is 0-2 bar; coating weight gain is 1% -3%;
s17: adopting polyvinyl chloride solid medicinal hard sheets and medicinal aluminum foils to carry out aluminum-plastic packaging to obtain an aluminum-plastic plate; the molding temperature is 60-110 ℃; the heat sealing temperature is 80-160 ℃; cutting speed is 40-180 cutting/min;
s18: and (5) externally packing to obtain a finished product and warehousing.
Example 1
The sodium argatrovix tablet is prepared by adopting the dry granulation method, and consists of the following raw materials in parts by weight:
the sodium elvagogram is an active substance, the soluble starch is a filler, the hypromellose is an adhesive, the stearic acid is a lubricant, the potassium citrate is a stabilizer, the medicinal film coating premix auxiliary material is a coating material, the purified water is a solvent, the purified water is removed in the coating process, the sheet preparation is completed, and the water content in the product is extremely low.
The preparation method of the Igacross sodium tablet comprises the following steps:
s11: crushing auxiliary material potassium citrate for 2 times, and pre-treating the crushed potassium citrate by a screen with the diameter of 1.0 mm; and the grinding rotating speed is 1000-5000 rpm;
particle size distribution
S12: adding auxiliary materials of soluble starch, hypromellose, stearic acid and raw material of Alagox sodium, premixing, and sieving with a screen with phi of 0.8-3.0 mm to obtain mixed powder; the rotation speed of the mixing is 5-10 rpm; mixing time is 3-6 min;
s13: adding stearic acid into the mixed powder, mixing, and performing dry granulation to obtain dry granulation granules; the rotating speed of the spiral feeding mechanism 9 is 10-50 rpm; the rotating speed of the press roller 6 is 10-50 rpm; the pressure of the press roll 6 is 10 to 30bar; the gap of the press roll 6 is 1mm; the thickness of the extrusion sheet is 1-3 mm; the aperture of the screen is 1.5mm; the rotating speed of the grain finishing mechanism 12 is 10-50 rpm;
s14: adding potassium citrate, stearic acid and microcrystalline cellulose to perform total mixing to obtain total mixed particles with excellent content uniformity and good fluidity; mixing speed 10rpm; mixing time is 5min;
s15: tabletting to obtain the sodium alagolide tablet with small tablet weight difference, quick disintegration aging and good formability; tabletting speed is 40-90 kilo tablets/hour; the filling depth is 3.0-9.9 mm; the thickness of the main pressing sheet is 1.0-3.5 mm; the thickness of the pre-pressed sheet is 1.3-4.55 mm; the rotation speed of the powder feeder is 50-90 rpm;
s16: coating the tablet with medicinal film coating premix auxiliary material gastric dissolution type to obtain a uniform film coated sodium alagolicum tablet; the air inlet is 500-3500 m 3 The method comprises the steps of carrying out a first treatment on the surface of the The air inlet temperature is 40-60 ℃; the temperature of the slice bed is 20-35 ℃; the atomization pressure is 0-2 bar; coating weight gain is 1% -3%;
s17: adopting polyvinyl chloride solid medicinal hard sheets and medicinal aluminum foils to carry out aluminum-plastic packaging to obtain an aluminum-plastic plate; the molding temperature is 60-110 ℃; the heat sealing temperature is 80-160 ℃; cutting speed is 40-180 cutting/min
S18: and (5) externally packing to obtain a finished product and warehousing.
Example two
The sodium argatrovix tablet is prepared by adopting the dry granulation method, and consists of the following raw materials in parts by weight:
the sodium elvagogram is an active substance, the soluble starch is a filler, the hypromellose is an adhesive, the stearic acid is a lubricant, the potassium citrate is a stabilizer, the medicinal film coating premix auxiliary material is a coating material, the purified water is a solvent, the purified water is removed in the coating process, the sheet preparation is completed, and the water content in the product is extremely low.
The preparation method of the Igacross sodium tablet comprises the following steps:
s11: crushing auxiliary material potassium citrate for 2 times, and pre-treating the crushed potassium citrate by a screen with the diameter of 1.0-2.0 mm; and the grinding rotating speed is 1000-5000 rpm;
s12: adding auxiliary materials of soluble starch, hypromellose, stearic acid and raw material of Alagox sodium, premixing, and sieving with a screen with phi of 0.8-3.0 mm to obtain mixed powder; the rotation speed of the mixing is 5-10 rpm; mixing time is 3-6 min;
s13: adding stearic acid into the mixed powder, mixing, and performing dry granulation to obtain dry granulation granules; the rotating speed of the spiral feeding mechanism 9 is 10-50 rpm; the rotating speed of the press roller 6 is 10-50 rpm; the pressure of the press roll 6 is 0 to 30bar; the gap of the press roll 6 is 2mm; the thickness of the extrusion sheet is 1-3 mm; the aperture of the screen is 1.5mm; the rotating speed of the grain finishing mechanism 12 is 10-50 rpm;
s14: adding potassium citrate, stearic acid and microcrystalline cellulose to perform total mixing to obtain total mixed particles with excellent content uniformity and good fluidity; mixing speed 10rpm; mixing time is 5min;
s15: tabletting to obtain the sodium alagolide tablet with small tablet weight difference, quick disintegration aging and good formability; tabletting speed is 40-90 kilo tablets/hour; the filling depth is 3.0-9.9 mm; the thickness of the main pressing sheet is 1.0-3.5 mm; the thickness of the pre-pressed sheet is 1.3-4.55 mm; the rotation speed of the powder feeder is 50-90 rpm;
s16: coating the tablet with medicinal film coating premix auxiliary material gastric dissolution type to obtain a uniform film coated sodium alagolicum tablet; the air inlet is 500-3500 m 3 The method comprises the steps of carrying out a first treatment on the surface of the The air inlet temperature is 40-60 ℃; the temperature of the slice bed is 20-35 ℃; the atomization pressure is 0-2 bar; coating weight gain is 1% -3%;
s17: adopting polyvinyl chloride solid medicinal hard sheets and medicinal aluminum foils to carry out aluminum-plastic packaging to obtain an aluminum-plastic plate; the molding temperature is 60-110 ℃; the heat sealing temperature is 80-160 ℃; cutting speed is 40-180 cutting/min
S18: and (5) externally packing to obtain a finished product and warehousing.
Working principle: debugging the dry granulating machine according to the granulating size requirement, controlling the electric push rod 13 to push the movable main shaft 5 to slide along the regulating notch 4, and controlling the gap between the two pressing rollers 6; meanwhile, the tightness degree of the synchronous belt 8 is adjusted, the motor 20 drives the bidirectional screw rod 19 to rotate, the sliding blocks 21 at two sides are driven to slide along the slide ways 18, the clamping plates 23 at two sides are mobilized to move relatively, the synchronous belt 8 is driven to tighten towards two sides or stretch towards the middle, and the tightness degree of the synchronous belt 8 is adjusted;
the crushed and ground materials are added into the hopper 10, the materials are conveyed between the two press rolls 6 by the spiral conveying mechanism 9, at the moment, the power unit in the machine body 1 drives the fixed main shaft 3 to rotate, and the movable main shaft 5 is driven to rotate through the transmission of the synchronous wheel 7 and the synchronous belt 8, so that the two press rolls 6 rotate, and the powdery materials are pressed into sheets; the pressed slices fall onto the pre-crushing assembly 11 and are crushed into slices with different sizes by the pre-crushing assembly 11; then falls into the grain finishing mechanism 12, and is extruded, sieved and shaped to prepare grains meeting the specification; the elastic force of the spring 31 pushes the scraper 29 to slide along the long screw 30, so that the edge of the scraper 29 always contacts with the outer wall of the press roller 6, powder stained on the surface of the press roller 6 is scraped off, the cleaning degree of the surface of the press roller 6 is improved, and the efficiency and quality of pressing materials into sheets are improved; the acceptable granules fall from the bottom of the housing 2.
The foregoing has shown and described the basic principles, principal features and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (10)
1. A dry granulation process, characterized by: the dry granulation method comprises the following steps:
s01: debugging the dry granulating machine according to the granulating size requirement, controlling the electric push rod (13) to push the movable main shaft (5) to slide along the adjusting notch (4), and controlling the gap between the two pressing rollers (6);
s02: meanwhile, the control motor (20) drives the sliding blocks (21) at two sides to slide along the slideway (18), drives the synchronous belt (8) to tighten towards two sides or stretch towards the middle part, and adjusts the tightness degree of the synchronous belt (8);
s03: the crushed and ground materials are added into the hopper (10), the materials are conveyed between the two press rolls (6) by the spiral conveying mechanism (9), at the moment, the power unit in the machine body (1) drives the fixed main shaft (3) to rotate, and the movable main shaft (5) is driven to rotate through the transmission of the synchronous wheel (7) and the synchronous belt (8), so that the two press rolls (6) rotate, and the powdery materials are pressed into sheets;
s04: the pressed slices fall onto a pre-crushing assembly (11) and are crushed into slices with different sizes by the pre-crushing assembly (11); then the mixture falls into a grain finishing mechanism (12), and grains are finished by extrusion and sieving to prepare grains meeting the specification;
s05: the acceptable particles fall from the bottom of the housing (2).
2. A dry granulation process according to claim 1, characterized in that: the dry granulating machine comprises a machine body (1), a granulating unit is fixedly connected to one side outer wall of the machine body (1), a power unit is arranged in the machine body (1) and used for providing driving force for the granulating unit, the granulating unit comprises a shell (2), one side outer wall fixedly connected with the shell (2) of the machine body (1), an extrusion mechanism is arranged on the top side of the shell (2), the extrusion mechanism comprises a fixed spindle (3), the shell (2) is close to one side top of the machine body (1) and is rotationally provided with the fixed spindle (3), one end of the fixed spindle (3) penetrates through the outer wall of the machine body (1) and is connected with the power unit, an adjusting notch (4) is formed in the top of one side of the shell (2) close to the machine body (1), a movable spindle (5) is slidably mounted in the inner side of the adjusting notch (4), the outer wall of the movable spindle (5) is in rotary fit with the adjusting notch (4), one end of the fixed spindle (3) and one end of the outer ring of the inner part of the shell (2) is fixedly connected with a compression roller (6), one end of the fixed spindle (3) is close to one end of the outer ring (7) of the machine body (1), and two synchronous wheels (7) are fixedly connected with one end of the outer ring (7) of the machine body (7).
3. A dry granulation process according to claim 2, characterized in that: screw feeding mechanism (9) are fixedly connected to one side top of shell (2), screw feeding mechanism (9) are kept away from one end top rigid coupling of shell (2) and have hopper (10), and the feed inlet of hopper (10) discharge gate intercommunication screw feeding mechanism (9), hopper (10) and organism (1) rigid coupling, between two compression roller (6) are connected to the discharge gate of screw feeding mechanism (9), one side that screw feeding mechanism (9) was kept away from to the inside of shell (2) is provided with pre-crushing subassembly (11), the inside bottom of shell (2) is provided with whole grain mechanism (12).
4. A dry granulation process according to claim 2, characterized in that: the utility model discloses a motor-driven main shaft of engine, including casing (2) and fixed cover (14), engine body (1), fixed cover (14) are installed in the middle part outer lane rotation that is close to one side top rigid coupling of casing (2), fixed cover (14)'s inside is rotated and is installed the bearing, the top of fixed cover (14) is through flange rigid coupling with the slide bar tip of electric putter (13), the both sides of adjusting notch (4) all are provided with slide rail (15), slide rail (15) and casing (2) rigid coupling, inside slidable mounting of slide rail (15) has guide block (16), the middle part rigid coupling of guide block (16) has connecting rod (17), the side lug of fixed cover (14) is run through in the sliding of connecting rod (17), locking screw is installed to the side lug screw thread of fixed cover (14).
5. A dry granulation process according to claim 2, characterized in that: the utility model discloses a synchronous belt (8) of motor, including shell (2), slide (18) have one side rigid coupling that is close to organism (1), slide (18) are located between fixed spindle (3) and movable spindle (5), the inside rotation of slide (18) is installed bi-directional screw (19), the one end of slide (18) is provided with motor (20), the outer wall rigid coupling of motor (20) and shell (2), the pivot of motor (20) and the tip rigid coupling of bi-directional screw (19), the equal slidable mounting in inside both ends of slide (18) has slider (21), bi-directional screw (19) run through slider (21), and bi-directional screw (19) and slider (21) screw-thread fit, fixed slot (22) have all been seted up to the both sides of slider (21), the inside slidable mounting of fixed slot (22) has splint (23), and through the bolt rigid coupling between splint (23) and slider (21), two with synchronous belt (8) sliding fit between splint (23).
6. A dry granulation process according to claim 4, characterized in that: the one side rigid coupling that fixed cover (14) is close to shell (2) has stop board (24), the one side rigid coupling that stop board (24) is close to shell (2) has rubber pad (25), the inner circle of rubber pad (25) and the outer lane normal running fit of moving main shaft (5), the inner circle of rubber pad (25) encircles the rigid coupling has a plurality of rubber lug (26).
7. A dry granulation process according to claim 3, characterized in that: the spiral feeding mechanism is characterized in that a supporting plate (27) is fixedly connected to a discharge hole of the spiral feeding mechanism (9), the supporting plate (27) is sleeved on the outer ring of the middle of the two compression rollers (6), baffle plates (28) are fixedly connected to two sides of the supporting plate (27), and one side, close to the baffle plates (28), of each baffle plate is in sliding fit with the side walls of the middle of the two compression rollers (6).
8. A dry granulation process according to claim 7, characterized in that: the utility model discloses a spiral feeding mechanism, including spiral feeding mechanism (9), scraper (29) are all provided with at the discharge gate top and the bottom of spiral feeding mechanism (9), long screw rod (30) are installed to both sides slidable mounting of scraper (29), and long screw rod (30) slip runs through scraper (29), the tip and the discharge gate outer wall threaded connection of spiral feeding mechanism (9) of long screw rod (30), the edge of a knife department and the outer wall sliding fit of compression roller (6) of scraper (29), the outer lane cover of long screw rod (30) is equipped with spring (31), spring (31) are located between the discharge gate outer wall of scraper (29) and spiral feeding mechanism (9).
9. The preparation method of the sodium Igacross tablet by the dry granulation method is characterized by comprising the following steps of: the sodium alagolide tablet is prepared by adopting the dry granulation method of claims 1 to 8, and consists of the following raw materials in parts by weight:
the sodium elvagogram is an active substance, the soluble starch is a filler, the hypromellose is an adhesive, the stearic acid is a lubricant, the potassium citrate is a stabilizer, the medicinal film coating premix auxiliary material is a coating material, the purified water is a solvent, the purified water is removed in the coating process, the sheet preparation is completed, and the water content in the product is extremely low.
10. The sodium alagolide tablet prepared by the dry granulation method according to claim 9, wherein: the preparation method of the Igacross sodium tablet comprises the following steps:
s11: crushing auxiliary material potassium citrate for 2 times, and pre-treating the crushed potassium citrate by a screen with the diameter of 1.0 mm; and the grinding rotating speed is 1000-5000 rpm;
s12: adding auxiliary materials of soluble starch, hypromellose, stearic acid and raw material of Alagox sodium, premixing, and sieving with a screen with phi of 0.8-3.0 mm to obtain mixed powder; the rotation speed of the mixing is 5-10 rpm; mixing time is 3-6 min;
s13: adding stearic acid into the mixed powder, mixing, and performing dry granulation to obtain dry granulation granules; the rotating speed of the spiral feeding mechanism (9) is 10-50 rpm; the rotating speed of the press roller (6) is 10-50 rpm; the pressure of the press roller (6) is 0-30 bar; the gap of the press roller (6) is 1-2 mm; the thickness of the extrusion sheet is 1-3 mm; the aperture of the screen is 1.5mm; the rotating speed of the grain finishing mechanism (12) is 10-50 rpm;
s14: adding potassium citrate, stearic acid and microcrystalline cellulose to perform total mixing to obtain total mixed particles with excellent content uniformity and good fluidity; mixing speed 10rpm; mixing time is 5min;
s15: tabletting to obtain the sodium alagolide tablet with small tablet weight difference, quick disintegration aging and good formability; tabletting speed is 40-90 kilo tablets/hour; the filling depth is 3.0-9.9 mm; the thickness of the main pressing sheet is 1.0-3.5 mm; the thickness of the pre-pressed sheet is 1.3-4.55 mm; the rotation speed of the powder feeder is 50-90 rpm;
s16: coating the plain tablet with medicinal film coating premix auxiliary materials (gastric dissolution type) to obtain an Airagoke sodium tablet with uniform film coating; the air inlet is 500-3500 m 3 The method comprises the steps of carrying out a first treatment on the surface of the The air inlet temperature is 40-60 ℃; the temperature of the slice bed is 20-35 ℃; the atomization pressure is 0-2 bar; coating weight gain is 1% -3%;
s17: adopting polyvinyl chloride solid medicinal hard sheets and medicinal aluminum foils to carry out aluminum-plastic packaging to obtain an aluminum-plastic plate; the molding temperature is 60-110 ℃; the heat sealing temperature is 80-160 ℃; cutting speed is 40-180 cutting/min;
s18: and (5) externally packing to obtain a finished product and warehousing.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN205886798U (en) * | 2016-07-29 | 2017-01-18 | 石家庄科源机械设备有限公司 | External isolated dry process granulator |
| CN108176327A (en) * | 2018-01-23 | 2018-06-19 | 宜春万申制药机械有限公司 | A kind of dry granulating machine |
| CN112844231A (en) * | 2021-01-14 | 2021-05-28 | 广东一方制药有限公司 | Dry granulating machine and dry granulating method |
| CN216224260U (en) * | 2021-11-22 | 2022-04-08 | 江西艾施特制药有限公司 | Dry-process granulator with constant-temperature detection function |
| CN114948889A (en) * | 2022-06-17 | 2022-08-30 | 哈药集团技术中心 | Preparation method of oxalagrange tablets and prepared oxalagrange tablets |
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