CN110638767B - Vitamin E solid tablet and preparation method thereof - Google Patents
Vitamin E solid tablet and preparation method thereof Download PDFInfo
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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
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
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- 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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- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract
The invention discloses a vitamin E solid tablet and a preparation method thereof, and provides a vitamin E solid tablet which comprises the following raw materials in parts by weight: 40-45 parts of octadecanoyl octadecanoic acid pullulan polysaccharide ester, 1.5-2.0 parts of vitamin E, 45-55 parts of maltodextrin and the balance of auxiliary materials. The invention also provides a preparation method of the vitamin E solid tablet, which comprises the following steps: s1, swelling; s2, mixing; s3, homogenizing under high pressure; s4, remixing; s5, spray drying; s6, mixing; s7, granulating; s8, tabletting. The solid vitamin E tablet provided by the invention has more uniform content of the sanitary element E in each solid tablet, can enable the daily intake of vitamins of a user to be more balanced, and has compact structure, is not easy to break, is melted in the mouth when being eaten, and has no uncomfortable feeling.
Description
Technical Field
The invention relates to the technical field of vitamin E preparation, in particular to a vitamin E solid tablet and a preparation method thereof.
Background
Natural Vitamin E (VE) is a fat-soluble vitamin, also called tocopherol, is a common medicine and health product, and is one of the most main natural antioxidants. The vitamin E is dissolved in extractants such as fat, isobutane and the like, is insoluble in water, is stable to heat and acid, is unstable to alkali, is sensitive to oxygen and is insensitive to heat, but the activity of the vitamin E is obviously reduced during frying. Tocopherol can promote sex hormone
Secretion, increasing the sperm motility and number of the male; increase female estrogen concentration, improve fertility, prevent abortion, and can be used for preventing and treating male infertility, burn, cold injury, capillary hemorrhage, climacteric syndrome, and skin care. Recently, vitamin E has also been found to inhibit the lipid peroxidation in the lens of the eye, dilate peripheral blood vessels and improve blood circulation. The existing vitamin E is mostly a capsule which contains a vitamin solution, is limited by a processing technology, and the existing vitamin solid tablet has poor comfort when being taken, is unsafe when being taken for a long time and can generate side effects.
The traditional water-insoluble oily substance loading adopts a microcapsule embedding technology, the particle size of the microcapsule is generally different from 5 to 200 mu m, the shape is various, the embedded substance is called as a core material depending on raw materials and a preparation method. The microcapsule embedding technology can effectively reduce the reaction of active substances to external environmental factors such as light, oxygen and water, reduce the diffusion and evaporation of the core material to the environment, control the release of the core material, mask the peculiar smell of the core material, change the physical properties (including color, shape, density and dispersion performance) and chemical properties of the core material and the like.
The nano particles, also called nano dust, nano dust refer to nano-scale microscopic particles. The self-assembly nanoparticles refer to nanoparticles with ordered structures formed by various materials spontaneously, and can be loaded with oily substances to prepare oil-loaded nanoparticles.
The oil-loaded nano particles have the advantages of microcapsules, and the particle size of the oil-loaded nano particles is far smaller than that of the microcapsules, so that the core materials can be more uniformly dispersed in products and are favored by people. Compared with a vitamin E soft capsule, the vitamin E microcapsule can improve the absorption efficiency by about 2 times; compared with the vitamin E microcapsule, the nano particles loaded with the vitamin E have smaller physical size, and the absorption efficiency is improved by nearly ten times.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: provides a vitamin E solid tablet with good taking comfort and also provides a preparation method of the vitamin E fixed body tablet.
In order to solve the problems, the invention provides a vitamin E solid tablet which comprises the following raw materials in parts by weight: octadecanoyl octadecanoic acid pullulan polysaccharide ester: 40-45 parts of vitamin E: 1.5-2.0 parts of maltodextrin: 45-55 parts of auxiliary materials in balance.
Preferably, the auxiliary materials comprise white granulated sugar, microcrystalline cellulose, ethyl maltol, magnesium stearate and aspartame.
As optimization, the invention comprises the following raw materials in parts by weight: octadecanoyl octadecanoic acid pullulan polysaccharide ester: 42 parts, vitamin E: 1.6 parts, maltodextrin: 53 parts, white granulated sugar: 2 parts, microcrystalline cellulose: 1 part, ethyl maltol: 0.1 part, magnesium stearate: 0.2 part and aspartame: 0.1 part.
As optimization, the invention comprises the following raw materials in parts by weight: octadecanoyl octadecanoic acid pullulan polysaccharide ester: 45 parts, vitamin E: 1.8 parts, maltodextrin: 49.8 parts, white granulated sugar: 2 parts, microcrystalline cellulose: 1 part, ethyl maltol: 0.1 part, magnesium stearate: 0.2 part and aspartame: 0.1 part.
As optimization, the invention comprises the following raw materials in parts by weight: octadecanoyl octadecanoic acid pullulan polysaccharide ester: 45 parts, vitamin E: 2.0 parts, maltodextrin: 49.6 parts, white granulated sugar: 2 parts, microcrystalline cellulose: 1 part, ethyl maltol: 0.1 part, magnesium stearate: 0.2 part and aspartame: 0.1 part.
The invention also provides a preparation method of the vitamin E solid tablet, which prepares the following raw materials in parts by weight: octadecanoyl octadecanoic acid pullulan polysaccharide ester: 40-45 parts of vitamin E: 1.5-2.0 parts of maltodextrin: 45-55 parts of white granulated sugar, microcrystalline cellulose, ethyl maltol, magnesium stearate and aspartame;
the preparation method comprises the following steps:
s1, swelling: adding octadecanoyl octadecanoic acid pullulan polysaccharide ester into water, wherein the swelling time is 5 hours, and obtaining a first solution;
s2, mixing: adding raw material vitamin E into the first solution obtained in the step S1, and stirring for 30min to obtain a second solution;
s3, high-pressure homogenization: homogenizing the vitamin E dispersion liquid in the step S2 at high pressure until a uniform third solution is obtained; the particle size of the nanoparticles in the solution was measured to be 180-190 nm using a nanometer particle size meter (Mastersizer 3000 from Malvern, uk).
S4, remixing: adding maltodextrin into S3, mixing uniformly to obtain a fourth solution, and controlling the solid content in the mixed solution to be 20-30%;
s5, spray drying: spray drying the fourth solution obtained in the step S4 to obtain solid powder rich in vitamin E nano particles;
s6, mixing: mixing the vitamin E nano particle powder obtained in the step S5 with white granulated sugar, microcrystalline cellulose, ethyl maltol, magnesium stearate and aspartame;
s7, granulating: granulating the mixed raw and auxiliary materials in the step S6 through a granulator;
s8, tabletting: and (5) tabletting the prepared granules in the step S7 through a tabletting machine to obtain the vitamin E solid tablets.
Preferably, in step S3, the high-pressure homogenizing process of the vitamin E dispersion is performed by a high-pressure homogenizer, wherein the working pressure of the high-pressure homogenizer is 120 MPa.
As an optimization, the spray drying process in the step S5 is realized by a spray drying system, and the inlet air temperature of the spray drying system is 120-130 ℃, the rotational speed of the atomizer is 21000 r/min, and the feed flow is 35-50 ml/min in the spray drying process.
Preferably, in step S1, the ratio of the octadecanoyl octadecanoic acid pullulan polysaccharide ester to the water is 1:30-1: 20.
Preferably, the stirring process in step S2 is implemented by a high-speed stirring disperser, and the operating speed of the high-speed stirring disperser is 15000-.
The invention has the beneficial effects that: the technology can effectively reduce the reaction of the vitamin E to external environmental factors (such as light, oxygen and water) and prevent the change of the physical properties (including color, shape, density and dispersion property) and chemical properties of the vitamin E. And the particle size of the nano particles is far smaller than that of the micron-sized microcapsules, so that the vitamin E can be more uniformly dispersed in the product. The vitamin E solid tablet provided by the invention has more uniform vitamin E content in each solid tablet, can enable the daily intake of vitamins of a user to be more balanced, and has compact structure, is not easy to break, is melted in the mouth when being eaten, and has no uncomfortable feeling.
Detailed Description
Example one
The vitamin E solid tablet of the embodiment comprises the following raw materials in parts by weight: hydroxypropyl cellulose: 50 parts, vitamin E: 1.5 parts, maltodextrin: 45.1 parts, white granulated sugar: 2 parts, microcrystalline cellulose: 1 part, ethyl maltol: 0.1 part, magnesium stearate: 0.2 part and aspartame: 0.1 part.
The vitamin E solid tablet described in this example was prepared by the following steps:
s1, adding all the raw materials into a stirrer, and fully stirring and mixing;
s2, granulating: granulating the mixed raw and auxiliary materials in the step S6 through a granulator;
s3, tabletting: and (5) tabletting the prepared granules in the step S7 through a tabletting machine to obtain the vitamin E solid tablets.
Example two
The vitamin E solid tablet of the embodiment comprises the following raw materials in parts by weight: octadecanoyl octadecanoic acid pullulan polysaccharide ester: 42 parts, vitamin E: 1.6 parts, maltodextrin: 53 parts, white granulated sugar: 2 parts, microcrystalline cellulose: 1 part, ethyl maltol: 0.1 part, magnesium stearate: 0.2 part and aspartame: 0.1 part. Wherein, the chemical molecular formula of the octadecanoyl octadecanoic acid pullulan polysaccharide ester is as follows:
the vitamin E solid tablet described in this example was prepared by the following steps:
s1, swelling: adding octadecanoyl octadecanoic acid pullulan polysaccharide ester into water, wherein the proportion of the octadecanoyl octadecanoic acid pullulan polysaccharide ester to the water is 1:25, the swelling time is 5 hours, and obtaining a first solution;
s2, mixing: adding vitamin E as a raw material into the first solution obtained in the step S1, and stirring for 30min by a high-speed stirring dispersion machine, wherein the working speed of the high-speed stirring dispersion machine is 1200r/min, so as to obtain a second solution;
s3, high-pressure homogenization: homogenizing the vitamin E dispersion liquid obtained in the step S2 by a high-pressure homogenizer at the working pressure of 120MPa until a uniform third solution is obtained; the size of the nanoparticles in the solution was determined to be 182nm using a nanometer size determinator (Mastersizer 3000 from Malvern, uk).
S4, adding maltodextrin into the S3, uniformly mixing to obtain a fourth solution, and controlling the solid content in the mixed solution to be 20%;
s5, spray drying: spray drying the fourth solution obtained in the step S4 through a spray drying system, wherein the air inlet temperature of the spray drying system is 130 ℃, the rotational speed of an atomizer is 21000 r/min, and the feed flow is 40 ml/min, so as to obtain solid powder rich in vitamin E nano particles;
s6, mixing: mixing the vitamin E nano particle powder obtained in the step S5 with white granulated sugar, microcrystalline cellulose, ethyl maltol, magnesium stearate and aspartame;
s7, granulating: granulating the mixed raw and auxiliary materials in the step S6 through a granulator;
s8, tabletting: and (5) tabletting the prepared granules in the step S7 through a tabletting machine to obtain the vitamin E solid tablets.
EXAMPLE III
Octadecanoyl octadecanoic acid pullulan polysaccharide ester: 45 parts, vitamin E: 2.0 parts, maltodextrin: 49.6 parts, white granulated sugar: 2 parts, microcrystalline cellulose: 1 part, ethyl maltol: 0.1 part, magnesium stearate: 0.2 part and aspartame: 0.1 part.
The vitamin E solid tablet described in this example was prepared by the following steps:
s1, swelling: adding octadecanoyl octadecanoic acid pullulan polysaccharide ester into water, wherein the proportion of the octadecanoyl octadecanoic acid pullulan polysaccharide ester to the water is 1:25, the swelling time is 5 hours, and obtaining a first solution;
s2, mixing: adding vitamin E as a raw material into the first solution obtained in the step S1, and stirring for 30min by a high-speed stirring dispersion machine, wherein the working speed of the high-speed stirring dispersion machine is 1200r/min, so as to obtain a second solution;
s3, high-pressure homogenization: homogenizing the vitamin E dispersion liquid obtained in the step S2 by a high-pressure homogenizer at the working pressure of 120MPa until a uniform third solution is obtained; the nanoparticles in the solution were measured to have a particle size of 187nm using a nanometer size meter (Mastersizer 3000 from Malvern, uk).
S4, adding maltodextrin into the S3, uniformly mixing to obtain a fourth solution, and controlling the solid content in the mixed solution to be 20%;
s5, spray drying: spray drying the fourth solution obtained in the step S4 through a spray drying system, wherein the air inlet temperature of the spray drying system is 130 ℃, the rotational speed of an atomizer is 21000 r/min, and the feed flow is 40 ml/min, so as to obtain solid powder rich in vitamin E nano particles;
s6, mixing: mixing the vitamin E nano particle powder obtained in the step S5 with white granulated sugar, microcrystalline cellulose, ethyl maltol, magnesium stearate and aspartame;
s7, granulating: granulating the mixed raw and auxiliary materials in the step S6 through a granulator;
s8, tabletting: and (5) tabletting the prepared granules in the step S7 through a tabletting machine to obtain the vitamin E solid tablets.
The vitamin E solid tablets described in examples one to three were subjected to a vitamin E uniformity test, a disintegration test and a swallow test.
Vitamin E net content test:
10 vitamin E solid tablets prepared in examples one to three were randomly sampled, and vitamin E was used as a detection component to test the content of vitamin E in each tablet:
experiment of disintegration
Taking 20 vitamin E solid tablets prepared in the first to third examples respectively, dropping each of the above vitamin E solid tablets from a height of 1 meter onto a hard ground, visually observing the degree of disintegration of the vitamin E solid tablets dropping onto the hard ground, and evaluating the degree of disintegration of each solid tablet by taking the percentage of the disintegrated solid tablets to the test number as the disintegration ratio, wherein the test results are as follows:
experiment of swallowing
20 testers were selected, and each of the vitamin E solid tablets of examples one to three was administered, and each of the solid tablets of examples was administered in two pieces, placed on the tongue without chewing, taken without water until the tablets completely disintegrated, and all suspended substances in the oral cavity were discharged, and the testers were allowed to fill in the evaluation.
The above embodiments are only specific examples of the present invention, and the protection scope of the present invention includes but is not limited to the product forms and styles of the above embodiments, and any suitable changes or modifications made by those skilled in the art according to the claims of the present invention shall fall within the protection scope of the present invention.
Claims (8)
1. A vitamin E solid tablet characterized by: the composite material comprises the following raw materials in parts by weight: 40-45 parts of octadecanoyl octadecanoic acid pullulan polysaccharide ester, 1.5-2.0 parts of vitamin E, 45-55 parts of maltodextrin, white granulated sugar, microcrystalline cellulose, ethyl maltol, magnesium stearate and aspartame;
the preparation method comprises the following steps:
s1, swelling: adding octadecanoyl octadecanoic acid pullulan polysaccharide ester into water, wherein the swelling time is 5 hours, and obtaining a first solution;
s2, mixing: adding raw material vitamin E into the first solution obtained in the step S1, and stirring for 30min to obtain a second solution;
s3, high-pressure homogenization: homogenizing the vitamin E dispersion liquid in the step S2 at high pressure until a uniform third solution is obtained; measuring the particle size of the nanoparticles in the solution by using a nanometer particle size tester to be 180-190 nm;
s4, remixing: adding maltodextrin into S3, mixing uniformly to obtain a fourth solution, and controlling the solid content in the mixed solution to be 20-30%;
s5, spray drying: spray drying the fourth solution obtained in the step S4 to obtain solid powder rich in vitamin E nano particles;
s6, mixing: mixing the vitamin E nano particle powder obtained in the step S5 with white granulated sugar, microcrystalline cellulose, ethyl maltol, magnesium stearate and aspartame;
s7, granulating: granulating the mixed raw and auxiliary materials in the step S6 through a granulator;
s8, tabletting: tabletting the granules prepared in the step S7 through a tabletting machine to prepare a vitamin E solid tablet;
wherein, the chemical molecular formula of the octadecanoyl octadecanoic acid pullulan polysaccharide ester is as follows:
2. the vitamin E solid tablet of claim 1, wherein: the composite material comprises the following raw materials in parts by weight: octadecanoyl octadecanoic acid pullulan polysaccharide ester: 42 parts, vitamin E: 1.6 parts, maltodextrin: 53 parts, white granulated sugar: 2 parts, microcrystalline cellulose: 1 part, ethyl maltol: 0.1 part, magnesium stearate: 0.2 part and aspartame: 0.1 part.
3. The vitamin E solid tablet of claim 1, wherein: the composite material comprises the following raw materials in parts by weight: octadecanoyl octadecanoic acid pullulan polysaccharide ester: 45 parts, vitamin E: 1.8 parts, maltodextrin: 49.8 parts, white granulated sugar: 2 parts, microcrystalline cellulose: 1 part, ethyl maltol: 0.1 part, magnesium stearate: 0.2 part and aspartame: 0.1 part.
4. The vitamin E solid tablet of claim 1, wherein: the composite material comprises the following raw materials in parts by weight: octadecanoyl octadecanoic acid pullulan polysaccharide ester: 45 parts, vitamin E: 2.0 parts, maltodextrin: 49.6 parts, white granulated sugar: 2 parts, microcrystalline cellulose: 1 part, ethyl maltol: 0.1 part, magnesium stearate: 0.2 part and aspartame: 0.1 part.
5. The vitamin E solid tablet of claim 1, wherein: in step S3, the high-pressure homogenization of the vitamin E dispersion is performed by a high-pressure homogenizer, and the working pressure of the high-pressure homogenizer is 120 MPa.
6. The vitamin E solid tablet of claim 1, wherein: the spray drying process in the step S5 is realized by a spray drying system, and the air inlet temperature of the spray drying system is 120-.
7. The vitamin E solid tablet of claim 1, wherein: in step S1, the ratio of octadecanoyl octadecanoic acid pullulan polysaccharide ester to water is 1:30-1: 20.
8. The vitamin E solid tablet of claim 1, wherein: the stirring process in step S2 is realized by a high-speed stirring disperser, and the operating speed of the high-speed stirring disperser is 1200r/min during the stirring process.
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