CN113952311A - Preparation method of calcium carbonate vitamin D3 chewable tablet - Google Patents
Preparation method of calcium carbonate vitamin D3 chewable tablet Download PDFInfo
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- CN113952311A CN113952311A CN202111242590.5A CN202111242590A CN113952311A CN 113952311 A CN113952311 A CN 113952311A CN 202111242590 A CN202111242590 A CN 202111242590A CN 113952311 A CN113952311 A CN 113952311A
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/10—Carbonates; Bicarbonates
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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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
- A61K9/2009—Inorganic compounds
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
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Abstract
The invention discloses a preparation method of calcium carbonate vitamin D3 chewable tablets, which relates to the technical field of medicines and aims to solve the problems of poor stability of vitamin D3, great influence by environment and unfavorable production and storage, and the preparation method comprises the following steps: 1) preparing vitamin D3 powder. 2) Weighing raw and auxiliary materials according to the prescription amount for later use. 3) A10% K30-pigment solution was prepared using a 20% ethanol aqueous solution. 4) Putting calcium carbonate and mannitol into a wet granulator, pouring K30-pigment solution for granulation, drying and granulating. 5) And (4) mixing the granules obtained in the step (5) with other materials, and tabletting. The vitamin D3 powder prepared by the invention is not easy to photolyze and oxidize, has high thermal stability and greatly reduces the production cost. The prepared tablet has good taste and convenient carrying, and increases the compliance of patients. The invention is used in the field of medicine preparation.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a preparation method of calcium carbonate vitamin D3 chewable tablets.
Background
Along with the improvement of the awareness of calcium supplement of people, calcium supplement products in the market are diversified, and various products such as tablets and granules taking calcium carbonate as a raw material appear, but the calcium carbonate is poor in absorption when being taken alone, and the vitamin D3 can assist in the absorption of calcium, so that the utilization rate of the calcium carbonate in the body is greatly improved, and the market of the calcium carbonate vitamin D3 compound preparation is wider.
Vitamin D is a fat-soluble vitamin, i.e., vitamin DCyclopentane polyhydrophenanthreneCompounds of the class, functionally preventableRicketsOf (2), most preferablyMainly vitamins D3 and D2. Vitamin D3 is prepared from subcutaneous 7-dehydrocholesterol by ultraviolet irradiation. The main function of vitamin D is to promote the absorption of calcium and phosphorus by small intestinal mucosal cells. Calcium ion absorption in the intestine needs a calcium binding protein, 1, 25-dihydroxy vitamin D3 can induce the protein to synthesize, promote Ca2+ absorption, promote calcium salt regeneration and new bone formation, promote phosphorus absorption and renal tubule cell reabsorption of calcium and phosphorus, so that the concentration of blood calcium and blood phosphorus can be increased, and new bone formation and calcification are facilitated. In addition, vitamin D also has the effects of promoting the growth and differentiation of skin cells and regulating immune function. Children lack vitamin D can suffer from rickets and adults can suffer from osteomalacia.
Vitamin D3 is insoluble in water, is extremely unstable, is sensitive to light, heat and air, has great influence on stability by the environment, and is not beneficial to production and storage. And the content of the vitamin D3 in the tablet is extremely low, so that the mixing uniformity of the product is difficult to be qualified.
Disclosure of Invention
The invention aims to solve the problems that vitamin D3 is poor in stability, is greatly influenced by environment and is not beneficial to production and storage, and provides calcium carbonate vitamin D3 chewable tablets and a preparation method thereof.
The invention relates to a preparation method of calcium carbonate vitamin D3 chewable tablets, which is carried out according to the following steps:
step one, preparation of vitamin D3 powder
(1) Uniformly mixing a vitamin D3 raw material, a diluent, an antioxidant and a surfactant;
(2) uniformly mixing the mixture obtained in the step (1) in an adsorbent, sieving the mixture by a 80-mesh sieve, dispersing the mixture, and sieving the obtained product by the 80-mesh sieve for dispersing;
(3) dissolving the adhesive in 50% ethanol by volume;
(4) putting the material obtained in the step (2) and the encapsulant into a wet mixing granulator, mixing for 3-5 min after starting up, adding the solution prepared in the step (3) in a spraying manner, and granulating for 3-5 min;
(5) sieving the harvested material in the step (4) with a 18-mesh sieve, boiling and drying, and granulating the dried material by using a granulator to obtain a raw material of vitamin D3 powder;
step two, preparing calcium carbonate vitamin D3 chewable tablets
(6) Dissolving 1-5 parts by weight of povidone K30 and 0.01-0.1 part by weight of pigment in 20% ethanol solution by volume percentage;
(7) placing 60-80 parts by weight of calcium carbonate and 20-30 parts by weight of sorbitol or mannitol in a wet mixing granulator, mixing for 3-5 min, adding the solution prepared in the step (6), and granulating for 3-5 min;
(8) sieving, drying and dry granulating the material harvested in the step (7);
(9) and (3) uniformly mixing the material obtained in the step (8) with 0.01-0.05 part by weight of vitamin D3 powder, 0.5-1 part by weight of essence and 0.2-0.5 part by weight of aspartame or sucralose, and tabletting to obtain the calcium carbonate vitamin D3 chewable tablet.
Further, in the step (1), the mixture is mixed by stirring, homogenizing and ultrasonic processing.
Further, in the step (1), the diluent is heated to 80-85 ℃, and the vitamin D3 raw material, the antioxidant and the surfactant are added and stirred.
Further, the raw material of the vitamin D3 in the step (1) is pure vitamin D3 with 40000000IU/g, and the dosage of the raw material is 0.1-0.5% of the vitamin D3 powder.
Further, the diluent is edible oil, lipid or fat. Preferably, the oil is one or more of babassu oil, coconut oil, palm kernel oil, and medium chain triglyceride. Wherein the dosage of the medium chain triglyceride is 1 to 5 percent of the vitamin D3 powder.
Further, the antioxidant is dl-alpha-tocopherol, butylated hydroxytoluene, butylated hydroxyanisole or propyl gallate. Preferably, dl-alpha-tocopherol is used in an amount of 0.1% to 1% of the vitamin D3 powder.
Further, the surfactant is one or more of ascorbyl palmitate, polysorbate and polyethylene glycol. Preferably, polyethylene glycol 6000 is used, and the dosage of the polyethylene glycol 6000 is 0.1-0.5% of the vitamin D3 powder.
Further, the adsorbent is silica gel micropowder, polyethylene or polyvinyl chloride. Preferably, the micro silica gel powder is used, and the dosage of the micro silica gel powder is 5 to 10 percent of the vitamin D3 powder.
Further, the encapsulant is colloid, starch, sugar or protein. Including starch, proteins from animal sources (including gelatin), proteins from plant sources, agar, maltodextrin, sorbitol, mannitol, and any combination thereof. Preferably, modified corn starch is used in an amount of 80% to 90% of the vitamin D3 powder.
Further, the adhesive is povidone K30, sodium carboxymethylcellulose or hypromellose. Preferably, povidone K30 is used in an amount of 0.1-0.5% of the vitamin D3 powder.
Further, the aperture of the screen mesh in the step (5) is 0.5-1.0 mm.
The invention has the following beneficial effects:
according to the invention, the pure vitamin D3 is diluted by using a diluent, an adsorbent and the like, and then the vitamin D3 is further diluted and embedded by using an encapsulating agent, so that the solubility and the stability of the vitamin D3 are improved. And then the mixed granules of calcium carbonate and sorbitol, the prepared vitamin D3 powder and other auxiliary materials are uniformly mixed and tabletted by a granulation process. The obtained tablet has good stability, good taste, and high compliance, and reduces the cost of purchasing vitamin D3 powder.
Detailed Description
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples for carrying out the invention, and that various changes in form and details may be made therein without departing from the spirit and scope of the invention in practice.
To make the objects, aspects and advantages of the embodiments of the present invention more apparent, the following detailed description clearly illustrates the spirit of the disclosure, and any person skilled in the art, after understanding the embodiments of the disclosure, may make changes and modifications to the technology taught by the disclosure without departing from the spirit and scope of the disclosure.
The exemplary embodiments of the present invention and the description thereof are provided to explain the present invention and not to limit the present invention.
Example 1
Firstly, preparing vitamin D3 powder:
| prescription | Dosage of |
| Vitamin D3 | 5g |
| Medium chain triglycerides | 60g |
| dl-alpha-tocopherol | 20g |
| Polyethylene glycol | 10g |
| Silica gel micropowder | 300g |
| Modified corn starch | 1500g |
| Povidone K30 | 10g |
| Ethanol | 100g |
| Purified water | 100g |
(1) Heating medium chain triglyceride to about 80 deg.C, adding vitamin D3, dl-alpha-tocopherol, and polyethylene glycol under stirring, and stirring to mix well.
Adding the mixed solution into the micro silica gel powder, after the solution is completely absorbed, sieving the mixture by a 80-mesh sieve, and repeating the sieving operation once.
(2) Dissolving polyvidone K30 in 50% ethanol water solution.
(3) And (3) placing the material obtained in the step (1) and the modified corn starch in a wet mixing granulator, mixing for 3-5 min after starting up, adding the solution obtained in the step (2) in a spraying mode, and granulating for 3-5 min. And (6) harvesting.
(4) And (4) sieving the harvested material in the step (3) by using a 18-mesh sieve, boiling and drying, and granulating the dried material by using a granulator, wherein the mesh diameter of the sieve is 0.5-1.0 mm to obtain the vitamin D3 powder raw material.
Secondly, preparing calcium carbonate vitamin D3 chewable tablets:
| prescription | Dosage of |
| Vitamin D3 powder | 2g |
| Calcium carbonate | 1250g |
| Sorbitol | 500g |
| Magnesium stearate | 1.85g |
| Essence | 1.85g |
| Pigment | 0.1g |
| Aspartame | 1.85g |
| Povidone K30 | 10g |
| Ethanol | 30g |
| Purified water | 110g |
(6) Povidone K30 and pigment were dissolved in a 20% ethanol aqueous solution.
(7) And (3) placing the calcium carbonate and the sorbitol into a wet mixing granulator, mixing for 3-5 min, adding the solution prepared in the step (6), and granulating for 3-5 min. And (6) harvesting.
(8) And (4) sieving, drying and dry granulating the harvested material in the step (7).
(9) And (3) mixing the obtained material in the step (8) with the raw material of vitamin D3 powder, essence and aspartame in a gradient manner, and tabletting.
Example 2
Firstly, preparing vitamin D3 powder:
| prescription | Dosage of |
| Vitamin D3 | 4.95g |
| Medium chain triglycerides | 60g |
| dl-alpha-tocopherol | 20g |
| Polyethylene glycol | 10g |
| Silica gel micropowder | 300g |
| Maltodextrin 15 | 1350g |
| Povidone K30 | 10g |
| Ethanol | 90g |
| Purified water | 90g |
(1) Heating medium chain triglyceride to about 80 deg.C, adding vitamin D3, dl-alpha-tocopherol, and polyethylene glycol under stirring, and stirring to mix well.
Adding the mixed solution into the micro silica gel powder, after the solution is completely absorbed, sieving the mixture by a 80-mesh sieve, and repeating the sieving operation once.
(2) Dissolving polyvidone K30 in 50% ethanol water solution.
(3) And (3) placing the material obtained in the step (1) and maltodextrin 15 in a wet mixing granulator, mixing for 3-5 min after starting up, adding the solution obtained in the step (2) in a spraying manner, and granulating for 3-5 min. And (6) harvesting.
(4) And (4) sieving the harvested material in the step (3) by using a 18-mesh sieve, boiling and drying, and granulating the dried material by using a granulator, wherein the mesh diameter of the sieve is 0.5-1.0 mm to obtain the vitamin D3 powder raw material.
Secondly, preparing calcium carbonate vitamin D3 chewable tablets:
| prescription | Dosage of |
| Vitamin D3 powder | 2g |
| Calcium carbonate | 1250g |
| Mannitol | 500g |
| Magnesium stearate | 1.85g |
| Essence | 1.85g |
| Pigment | 0.1g |
| Sucralose | 0.55g |
| Povidone K30 | 10g |
| Ethanol | 36g |
| Purified water | 134g |
(6) Povidone K30 and pigment were dissolved in a 20% ethanol aqueous solution.
(7) And (3) placing the calcium carbonate and the mannitol into a wet mixing granulator, mixing for 3-5 min, adding the solution prepared in the step (6), and granulating for 3-5 min. And (6) harvesting.
(8) And (4) sieving, drying and dry granulating the harvested material in the step (7).
(9) And (3) mixing the material obtained in the step (8) with the raw material of the vitamin D3 powder, the essence and the sucralose uniformly in a gradient manner, and tabletting.
As a result: the tablets prepared in the above examples are bottled, sealed and stored at 40 ℃ under 75% humidity for 1 month, the content of vitamin D3 is reduced by 4%, and the content of calcium carbonate is not reduced. The vitamin D3 and the calcium carbonate content are not obviously reduced after the storage for 1 month at normal temperature.
The above examples are merely representative of embodiments of the present invention, and are described in more detail and detail, but not intended to limit the scope of the invention. Any alterations and modifications without departing from the principles of the inventive concept are intended to be within the scope of the invention.
Claims (10)
1. The preparation method of the calcium carbonate vitamin D3 chewable tablet is characterized by comprising the following steps:
step one, preparation of vitamin D3 powder
(1) Uniformly mixing a vitamin D3 raw material, a diluent, an antioxidant and a surfactant;
(2) uniformly mixing the mixture obtained in the step (1) in an adsorbent, sieving the mixture by a 80-mesh sieve, dispersing the mixture, and sieving the obtained product by the 80-mesh sieve for dispersing;
(3) dissolving the adhesive in 50% ethanol by volume;
(4) putting the material obtained in the step (2) and the encapsulant into a wet mixing granulator, mixing for 3-5 min after starting up, adding the solution prepared in the step (3) in a spraying manner, and granulating for 3-5 min;
(5) sieving the harvested material in the step (4) with a 18-mesh sieve, boiling and drying, and granulating the dried material by using a granulator to obtain a raw material of vitamin D3 powder;
step two, preparing calcium carbonate vitamin D3 chewable tablets
(6) Dissolving 1-5 parts by weight of povidone K30 and 0.01-0.1 part by weight of pigment in 20% ethanol solution by volume percentage;
(7) placing 60-80 parts by weight of calcium carbonate and 20-30 parts by weight of sorbitol or mannitol in a wet mixing granulator, mixing for 3-5 min, adding the solution prepared in the step (6), and granulating for 3-5 min;
(8) sieving, drying and dry granulating the material harvested in the step (7);
(9) and (3) uniformly mixing the material obtained in the step (8) with 0.01-0.05 part by weight of vitamin D3 powder, 0.5-1 part by weight of essence and 0.2-0.5 part by weight of aspartame or sucralose, and tabletting to obtain the calcium carbonate vitamin D3 chewable tablet.
2. The method for preparing chewable tablets containing calcium carbonate and vitamin D3 according to claim 1, wherein the step (1) comprises mixing by stirring, homogenizing and ultrasonic processing.
3. The preparation method of chewable tablets containing calcium carbonate and vitamin D3 according to claim 1, wherein the diluent in step (1) is heated to 80-85 ℃, the raw material of vitamin D3, the antioxidant and the surfactant are added, and the mixture is stirred.
4. The method for preparing chewable tablets of calcium carbonate and vitamin D3 as claimed in claim 1, wherein the raw material of vitamin D3 in step (1) is pure vitamin D3 of 40000000IU/g, and the dosage is 0.1% -0.5% of vitamin D3 powder.
5. The method for preparing calcium carbonate vitamin D3 chewable tablets according to claim 1, wherein the diluent is edible oil, lipid or fat.
6. The method for preparing calcium carbonate vitamin D3 chewable tablets according to claim 1, wherein the antioxidant is dl-alpha-tocopherol, butylated hydroxytoluene, butylated hydroxyanisole or propyl gallate.
7. The preparation method of the chewable tablet containing calcium carbonate and vitamin D3 as claimed in claim 1, wherein the surfactant is one or more of ascorbyl palmitate, polysorbate, and polyethylene glycol.
8. The method for preparing calcium carbonate vitamin D3 chewable tablets according to claim 1, wherein the adsorbent is aerosil, polyethylene or polyvinyl chloride.
9. The method for preparing chewable tablets containing calcium carbonate and vitamin D3 as claimed in claim 1, wherein the encapsulating agent is selected from the group consisting of gelatin, starch, sugar and protein.
10. The preparation method of the chewable tablet of calcium carbonate and vitamin D3 as claimed in claim 1, wherein the binder is povidone K30, sodium carboxymethylcellulose or hypromellose.
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| CN202111242590.5A CN113952311A (en) | 2021-10-25 | 2021-10-25 | Preparation method of calcium carbonate vitamin D3 chewable tablet |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103845357A (en) * | 2013-12-09 | 2014-06-11 | 浙江佐力药业股份有限公司 | Vitamin D calcium chewable tablet for calcium supplementation of children and preparation method thereof |
| CN106138087A (en) * | 2016-07-31 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of dimension D calcium composition chewable tablet and preparation method thereof |
| CN108420797A (en) * | 2018-05-09 | 2018-08-21 | 南京海融制药有限公司 | Novel vitamin D analogues preparation and preparation method thereof |
| CN109793238A (en) * | 2019-02-14 | 2019-05-24 | 武汉同济现代医药科技股份有限公司 | A kind of vitamin D inclusion powder and preparation method thereof and the application in health caring food tablet |
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2021
- 2021-10-25 CN CN202111242590.5A patent/CN113952311A/en not_active Withdrawn
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103845357A (en) * | 2013-12-09 | 2014-06-11 | 浙江佐力药业股份有限公司 | Vitamin D calcium chewable tablet for calcium supplementation of children and preparation method thereof |
| CN106138087A (en) * | 2016-07-31 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of dimension D calcium composition chewable tablet and preparation method thereof |
| CN108420797A (en) * | 2018-05-09 | 2018-08-21 | 南京海融制药有限公司 | Novel vitamin D analogues preparation and preparation method thereof |
| CN109793238A (en) * | 2019-02-14 | 2019-05-24 | 武汉同济现代医药科技股份有限公司 | A kind of vitamin D inclusion powder and preparation method thereof and the application in health caring food tablet |
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Application publication date: 20220121 |