CN116036035A - Preparation method of titanium dioxide-free raw fumaric acid Fu Nuola tablet - Google Patents

Preparation method of titanium dioxide-free raw fumaric acid Fu Nuola tablet Download PDF

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Publication number
CN116036035A
CN116036035A CN202310177850.8A CN202310177850A CN116036035A CN 116036035 A CN116036035 A CN 116036035A CN 202310177850 A CN202310177850 A CN 202310177850A CN 116036035 A CN116036035 A CN 116036035A
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tablet
nuola
fumaric acid
raw
titanium dioxide
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高琪琪
单鹏达
张运文
祝纯静
关小丽
宋晴晴
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Shandong Chengchuang Blue Sea Pharmaceutical Technology Co ltd
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Shandong Chengchuang Blue Sea Pharmaceutical Technology Co ltd
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Priority to CN202310177850.8A priority Critical patent/CN116036035A/en
Publication of CN116036035A publication Critical patent/CN116036035A/en
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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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • A61K9/2826Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention relates to the technical field of preparation of voronoi fumarate tablets, and discloses a preparation method of a Fu Nuola raw fumarate tablet without titanium dioxide. The preparation method of the titanium dioxide-free fumaric acid Fu Nuola raw tablet comprises the steps of mixing fumaric acid voronoi, a filler, a disintegrating agent, a binder and water, stirring the fumaric acid Fu Nuola raw tablet, the filler, the disintegrating agent and the binder by using a stirring shaft in the mixing process for 5 min, standing for about 2min, continuously stirring, circulating, and granulating in a wet granulator after stirring is finished to obtain fumaric acid Fu Nuola raw granules. According to the preparation method of the fumaric acid Fu Nuola raw tablet without titanium dioxide, the sample prepared by adopting the wet granulation process and the sample prepared by adopting the fluid bed granulation process have the capability of quick dissolution, and meanwhile, the prepared fumaric acid Fu Nuola raw tablet does not contain cancerogenic substances, so that the problem of huge potential safety hazards caused by patients after eating the tablet is solved, and the safety is high.

Description

Preparation method of titanium dioxide-free raw fumaric acid Fu Nuola tablet
Technical Field
The invention relates to the technical field of preparation of voronoi fumarate tablets, in particular to a preparation method of a Fu Nuola raw fumarate tablet without titanium dioxide.
Background
Titanium dioxide, an inorganic compound, has no toxicity, optimal opacity, optimal whiteness and brightness, is considered to be the best performing white pigment in the world today. The titanium white has strong adhesion, is not easy to generate chemical change and is always snowy white. Meanwhile, titanium dioxide has a good ultraviolet masking effect, is often used as a sun-screening agent to be mixed into textile fibers, the sun-screening agent is added into coating powder, and superfine titanium dioxide powder is also added into sun cream to prepare sun-screening cosmetics. Titanium dioxide may be obtained from the acid decomposition extraction of rutile or from the decomposition of titanium tetrachloride. Titanium dioxide is stable in nature and is used in large quantities as a white pigment in paints, has good hiding power, is similar to white lead, but does not turn black like white lead; it also has zinc white durability. Titanium dioxide is used as a coating agent, a coloring agent and an ultraviolet ray diluent in pharmaceutical preparations for preparing coated tablets, pills, granules, capsules and external preparations. In lakes, it is used as a masking agent to make the color uniform. Titanium dioxide is used in large amounts in coating powders for pharmaceutical preparations because of its special properties.
At present, the carcinogen list published by the international cancer research institute of the world health organization is primarily arranged and referenced, and titanium dioxide is in the 2B type carcinogen list, so that the Fu Nuola raw fumaric acid tablet prepared by continuously using titanium dioxide as a raw material contains carcinogen substances, and brings great potential safety hazard to patients.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a preparation method of a fumaric acid Fu Nuola raw tablet without titanium dioxide, which has the advantages of high safety and the like and solves the problem of bringing great potential safety hazard to patients.
In order to achieve the purpose of high safety, the invention provides the following technical scheme: the preparation method of the titanium dioxide-free raw fumaric acid Fu Nuola tablet is characterized by comprising the following raw materials in parts by weight: ten parts of raw materials are total, wherein, talcum powder is eight parts, mannitol is one part, and povidone K30 is one part.
Preferably, the talcum powder accounts for eighty percent of the total raw materials, and the calcium carbonate can replace talcum powder as a component of the titanium dioxide serving as an opacifier.
The invention aims to provide a preparation method of a raw fumaric acid Fu Nuola tablet without titanium dioxide, which is characterized by comprising the following steps:
s1, granulating raw materials
The fumaric acid Fu Nuola raw material, the filler, the disintegrating agent, the binder and the water provided by the invention are mixed, and in the mixing process, the fumaric acid Fu Nuola raw material, the filler, the disintegrating agent and the binder are stirred by using a stirring shaft for 5 min, and after standing for about 2min, the mixture is continuously stirred, so that the mixture circulates, and after the stirring is finished, the mixture is made into wet granules in a wet granulator, so as to obtain fumaric acid Fu Nuola raw granules.
S2, tabletting process
The tablet press is arranged on a firm wooden workbench (also can be arranged on a cement table) and is fixed by three pairs of M12 anchor screws, so that the stability of the tablet press is ensured, and then the mixed raw materials are placed in the tablet press for realizing the purpose of tabletting tablets.
S3, coating process
According to the characteristics and the specification of the tablet, the tablet is coated, when the tablet is coated, after the tablet core is pressed by one tablet press, the tablet core is transferred into a die hole of the other tablet press by a transfer device, fine powder outside the tablet is removed by a suction pump in the transfer process, before the tablet core reaches a second tablet press, part of coating material is filled into the die hole as a bottom layer, then the tablet core is placed on the die hole, and then the coating material is added to fill the die hole, and the coated tablet is formed by the second compression.
Preferably, in the step S1, the water is used in an amount of 10% -20% based on the total weight of the obtained Fu Nuola raw fumaric acid granules, and the granules are granulated to obtain granules with 20 meshes (0.9 mm pore size sieve) and a bulk density of 0.5-0.7g/ml and a compactibility of 0.6-0.8g/ml.
Preferably, in the step S1, the filler, the disintegrant and the binder are selected from one or more of the following: mannitol, microcrystalline cellulose, pregelatinized starch, crospovidone, croscarmellose sodium, povidone K30, hydroxypropyl cellulose and starch.
Preferably, in the step S2, the tablet thickness may be adjusted by itself, and the thin tablet thickness may be produced.
Preferably, in the step S3, the temperature should be controlled at 5-15 ℃ in the process of coating the tablets.
Compared with the prior art, the invention provides a preparation method of a fumaric acid Fu Nuola raw tablet without titanium dioxide, which has the following beneficial effects:
1. according to the preparation method of the fumaric acid Fu Nuola raw tablet without titanium dioxide, the sample prepared by adopting the wet granulation process and the sample prepared by adopting the fluid bed granulation process have the capability of quick dissolution, and meanwhile, the prepared fumaric acid Fu Nuola raw tablet does not contain cancerogenic substances, so that the problem of huge potential safety hazards caused by patients after eating the tablet is solved, and the safety is high.
Drawings
FIG. 1 is a flow chart of a method of producing a medicament according to the present invention;
FIG. 2 is a graph of data from the detection of bare sample placement under intense light;
FIG. 3 shows a test chart under a dissolution medium with the same dissolution profile test method.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The preparation method of the titanium dioxide-free raw fumaric acid Fu Nuola tablet is characterized by comprising the following raw materials in parts by weight: the raw materials are ten parts in total, wherein the talcum powder comprises eight parts, one part of mannitol and one part of povidone K30, the talcum powder accounts for eighty percent of the total raw materials, and the calcium carbonate can replace the talcum powder as a component of the titanium dioxide serving as a light screening agent.
The invention aims to provide a preparation method of a raw fumaric acid Fu Nuola tablet without titanium dioxide, which is characterized by comprising the following steps:
s1, granulating raw materials
The fumaric acid Fu Nuola raw material, the filler, the disintegrating agent, the binder and the water provided by the invention are mixed, and in the mixing process, the fumaric acid Fu Nuola raw material, the filler, the disintegrating agent and the binder are stirred by using a stirring shaft for 5 min, and after standing for about 2min, the mixture is continuously stirred, so that the mixture circulates, and after the stirring is finished, the mixture is made into wet granules in a wet granulator, so as to obtain fumaric acid Fu Nuola raw granules.
S2, tabletting;
the tablet press is arranged on a firm wooden workbench (also can be arranged on a cement table) and is fixed by three pairs of M12 anchor screws, so that the stability of the tablet press is ensured, and then the mixed raw materials are placed in the tablet press for realizing the purpose of tabletting tablets.
S3, coating process
According to the characteristics and the specification of the tablet, the tablet is coated, when the tablet is coated, after the tablet core is pressed by one tablet press, the tablet core is transferred into a die hole of the other tablet press by a transfer device, fine powder outside the tablet is removed by a suction pump in the transfer process, before the tablet core reaches a second tablet press, part of coating material is filled into the die hole as a bottom layer, then the tablet core is placed on the die hole, and then the coating material is added to fill the die hole, and the coated tablet is formed by the second compression.
The total weight of the obtained Fu Nuola raw fumaric acid granules is 10-20%, the granules are 20 meshes (0.9 mm aperture sieve), the bulk density is 0.5-0.7g/ml, the compactness is 0.6-0.8g/ml, and the filler, the disintegrating agent and the binder are selected from one or more of the following: mannitol, microcrystalline cellulose, pregelatinized starch, crospovidone, croscarmellose sodium, povidone K30, hydroxypropyl cellulose and starch, the tablet thickness can be adjusted by itself, the tablet thickness can be produced, and the temperature should be controlled at 5-15 ℃ in the process of coating the tablet.
Example 1 prescription:
fu Nuola raw fumaric acid 13 parts by weight
Mannitol 70 parts by weight
10 parts by weight of microcrystalline cellulose (pH 101)
2 parts by weight of croscarmellose sodium
Hydroxypropyl cellulose 2 weight portions
Purified water 20 parts by weight
2 parts by weight of croscarmellose sodium
1 part by weight of magnesium stearate
Film coating aqueous solution composition 4 parts by weight
Hydroxypropyl methylcellulose
Red iron oxide
Polyethylene glycol 6000
Talc powder
The preparation method comprises the following steps:
(1) Adhesive solution formulation
Weighing a prescription amount of hydroxypropyl cellulose, and dissolving the hydroxypropyl cellulose with purified water to obtain an aqueous solution of the hydroxypropyl cellulose;
(2) Granulating
Weighing the voronoi fumarate, mannitol, microcrystalline cellulose and croscarmellose sodium according to a prescription, putting the voronoi fumarate, mannitol, microcrystalline cellulose and croscarmellose sodium into a wet granulator together, and uniformly mixing; pouring the adhesive solution obtained in the step (1) into the uniformly mixed raw materials and auxiliary materials to prepare a soft material, stirring and granulating;
(3) Drying and granulating
Drying the prepared granules, and sieving and granulating the dried granules;
(4) General mixing
Uniformly mixing the finished dry particles with the prescribed amount of croscarmellose sodium and magnesium stearate;
(5) Tabletting, coating and packaging
Tabletting, coating and packaging the mixed granules.
Example 2 prescription:
fu Nuola raw fumaric acid 13 parts by weight
Mannitol 70 parts by weight
10 parts by weight of microcrystalline cellulose (pH 101)
2 parts by weight of croscarmellose sodium
Hydroxypropyl cellulose 2 weight portions
Purified water 20 parts by weight
2 parts by weight of croscarmellose sodium
1 part by weight of magnesium stearate
Film coating aqueous solution composition 4 parts by weight
Hydroxypropyl methylcellulose
Red iron oxide
Polyethylene glycol 6000
Zinc oxide
The preparation method comprises the following steps:
(1) Adhesive solution formulation
Weighing a prescription amount of hydroxypropyl cellulose, and dissolving the hydroxypropyl cellulose with purified water to obtain an aqueous solution of the hydroxypropyl cellulose;
(2) Granulating
Weighing the voronoi fumarate, mannitol, microcrystalline cellulose and croscarmellose sodium according to a prescription, putting the voronoi fumarate, mannitol, microcrystalline cellulose and croscarmellose sodium into a wet granulator together, and uniformly mixing; pouring the adhesive solution obtained in the step (1) into the uniformly mixed raw materials and auxiliary materials to prepare a soft material, stirring and granulating;
(3) Drying and granulating
Drying the prepared granules, and sieving and granulating the dried granules;
(4) General mixing
Uniformly mixing the finished dry particles with the prescribed amount of croscarmellose sodium and magnesium stearate;
(5) Tabletting, coating and packaging
Tabletting, coating and packaging the mixed granules.
Example 3 prescription:
fu Nuola raw fumaric acid 13 parts by weight
Mannitol 70 parts by weight
10 parts by weight of microcrystalline cellulose (pH 101)
2 parts by weight of croscarmellose sodium
Hydroxypropyl cellulose 2 weight portions
Purified water 20 parts by weight
2 parts by weight of croscarmellose sodium
1 part by weight of magnesium stearate
Film coating aqueous solution composition 4 parts by weight
Hydroxypropyl methylcellulose
Red iron oxide
Polyethylene glycol 6000
Titanium dioxide
The preparation method comprises the following steps:
(1) Adhesive solution formulation
Weighing a prescription amount of hydroxypropyl cellulose, and dissolving the hydroxypropyl cellulose with purified water to obtain an aqueous solution of the hydroxypropyl cellulose;
(2) Granulating
Weighing the voronoi fumarate, mannitol, microcrystalline cellulose and croscarmellose sodium according to a prescription, putting the voronoi fumarate, mannitol, microcrystalline cellulose and croscarmellose sodium into a wet granulator together, and uniformly mixing; pouring the adhesive solution obtained in the step (1) into the uniformly mixed raw materials and auxiliary materials to prepare a soft material, stirring and granulating;
(3) Drying and granulating
Drying the prepared granules, and sieving and granulating the dried granules;
(4) General mixing
Uniformly mixing the finished dry particles with the prescribed amount of croscarmellose sodium and magnesium stearate;
(5) Tabletting, coating and packaging
Tabletting, coating and packaging the mixed granules.
Example 4, recipe:
fu Nuola raw fumaric acid 13 parts by weight
Mannitol 70 parts by weight
10 parts by weight of microcrystalline cellulose (pH 101)
2 parts by weight of croscarmellose sodium
Hydroxypropyl cellulose 2 weight portions
Purified water 20 parts by weight
2 parts by weight of croscarmellose sodium
1 part by weight of magnesium stearate
Film coating aqueous solution composition 4 parts by weight
Hydroxypropyl methylcellulose
Red iron oxide
Polyethylene glycol 6000
Stearic acid
The preparation method comprises the following steps:
(1) Adhesive solution formulation
Weighing a prescription amount of hydroxypropyl cellulose, and dissolving the hydroxypropyl cellulose with purified water to obtain an aqueous solution of the hydroxypropyl cellulose;
(2) Granulating
And weighing the voronoi fumarate, mannitol, microcrystalline cellulose and croscarmellose sodium according to a prescription, putting the voronoi fumarate, mannitol, microcrystalline cellulose and croscarmellose sodium into a fluidized bed granulating and coating machine together, and preheating and mixing the mixture. Granulating the mixture while spraying the binder solution of step (1) to obtain granulated dry particles.
(3) Finishing grain
Sieving the prepared dry granules and granulating;
(4) General mixing
Uniformly mixing the finished dry particles with the prescribed amount of croscarmellose sodium and magnesium stearate;
(5) Tabletting, coating and packaging
Tabletting, coating and packaging the mixed granules.
The inventor finds through experiments that after titanium dioxide belonging to the class 2B cancerogenic substances is replaced by talcum powder, fumaric acid Fu Nuola is still stable under the illumination condition. And compared with the fluidized bed granulation process, the voronoi green sheet fumarate prepared by the wet granulation process can achieve the effect of quick dissolution.
The following describes the formulation of examples 1-3 of the present invention as a stable property under light conditions of the product after talc is substituted for titanium dioxide.
The experiment was set up according to the principle of single factor control, and the samples of examples 1-3 were exposed to intense light for 10 days for content and related substance detection, and the experimental data of the test are shown in the following table.
From the data of fig. 2, the following conclusions can be drawn:
under the same test conditions, talcum powder can be used for replacing titanium dioxide as a light shielding agent to keep the stability of the Vonopraz fumarate tablet under the illumination condition.
The wet granulation process preparation samples were given as examples 3, 4 of the invention, which showed equivalent fast dissolution properties as the fluid bed granulation process.
The experiment is set according to a single factor control principle, samples of the embodiment 3 and the embodiment 4 are detected by adopting the same dissolution curve detection method and the same dissolution medium, and specific experimental data are shown in figure 3.
From the data of fig. 3, the following conclusions can be drawn:
(1) Under the same test conditions, the samples prepared by the wet granulation process and the samples prepared by the fluid bed granulation process have the capability of quick dissolution.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (7)

1. The preparation method of the titanium dioxide-free raw fumaric acid Fu Nuola tablet is characterized by comprising the following raw materials in parts by weight: ten parts of raw materials are total, wherein, talcum powder is eight parts, mannitol is one part, and povidone K30 is one part.
2. The method for preparing a raw fumaric acid Fu Nuola tablet without titanium dioxide according to claim 1, wherein the talcum powder accounts for eighty percent of the total raw materials, and the calcium carbonate can be used as an ingredient of the titanium dioxide serving as an opacifier instead of talcum powder.
3. A method of preparing a titanium dioxide-free raw fumaric acid tablet Fu Nuola according to claim 1 comprising the steps of:
s1, granulating raw materials
Mixing the fumaric acid Fu Nuola raw material, the filler, the disintegrating agent, the binder and the water, stirring the fumaric acid Fu Nuola raw material, the filler, the disintegrating agent and the binder by using a stirring shaft in the mixing process for 5 min, standing for about 2min, continuing stirring, circulating, and preparing wet granules in a wet granulator after stirring to obtain fumaric acid Fu Nuola raw granules;
s2, tabletting process
The tablet press is arranged on a firm wooden workbench (also can be arranged on a cement table) and is fixed by three pairs of M12 anchor screws, so that the stability of the tablet press is ensured, and then the mixed raw materials are placed into the tablet press for realizing the purpose of tabletting tablets;
s3, coating process
According to the characteristics and the specification of the tablet, the tablet is coated, when the tablet is coated, after the tablet core is pressed by one tablet press, the tablet core is transferred into a die hole of the other tablet press by a transfer device, fine powder outside the tablet is removed by a suction pump in the transfer process, before the tablet core reaches a second tablet press, part of coating material is filled into the die hole as a bottom layer, then the tablet core is placed on the die hole, and then the coating material is added to fill the die hole, and the coated tablet is formed by the second compression.
4. The process for producing a raw fumaric acid Fu Nuola tablet free of titanium dioxide according to claim 1, wherein in the step S1, the amount of water is 10% -20% based on the total weight of the obtained Fu Nuola raw fumaric acid granules, and the granulation is such that the obtained granules are 20 mesh (0.9 mm pore size sieve), bulk density is 0.5-0.7g/ml and compactability is 0.6-0.8g/ml.
5. The method for preparing a raw fumaric acid Fu Nuola tablet without titanium dioxide according to claim 1, wherein in the step S1, the filler, the disintegrating agent and the binder are selected from one or more of the following: mannitol, microcrystalline cellulose, pregelatinized starch, crospovidone, croscarmellose sodium, povidone K30, hydroxypropyl cellulose and starch.
6. The method for preparing a raw fumaric acid Fu Nuola tablet without titanium dioxide according to claim 1, wherein in the step S2, the tablet thickness can be adjusted by itself, and the thick slices can be produced.
7. The method for preparing a raw fumaric acid Fu Nuola tablet without titanium dioxide according to claim 1, wherein in the step S3, the temperature is controlled to be 5-15 ℃ in the process of coating the tablet.
CN202310177850.8A 2023-02-28 2023-02-28 Preparation method of titanium dioxide-free raw fumaric acid Fu Nuola tablet Pending CN116036035A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117462507A (en) * 2023-12-28 2024-01-30 山东齐都药业有限公司 Vonola fumarate crude drug composition and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117462507A (en) * 2023-12-28 2024-01-30 山东齐都药业有限公司 Vonola fumarate crude drug composition and preparation method thereof
CN117462507B (en) * 2023-12-28 2024-03-15 山东齐都药业有限公司 Vonola fumarate crude drug composition and preparation method thereof

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