CN114617901A - Composition for preventing and treating diseases caused by B vitamins and vitamin C deficiency and preparation method thereof - Google Patents

Composition for preventing and treating diseases caused by B vitamins and vitamin C deficiency and preparation method thereof Download PDF

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CN114617901A
CN114617901A CN202210236536.8A CN202210236536A CN114617901A CN 114617901 A CN114617901 A CN 114617901A CN 202210236536 A CN202210236536 A CN 202210236536A CN 114617901 A CN114617901 A CN 114617901A
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vitamin
granules
granulation
vitamins
auxiliary materials
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何宇东
车挺
赵框圭
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Shaanxi Bicon Pharmaceutical Group Holding Co ltd
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Shaanxi Bicon Pharmaceutical Group Holding Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/4415Pyridoxine, i.e. Vitamin B6
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
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    • 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
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525Isoalloxazines, e.g. riboflavins, vitamin B2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135Compounds containing heavy metals
    • A61K31/714Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals

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Abstract

The invention discloses a composition for preventing and treating diseases caused by deficiency of B vitamins and vitamin C and a preparation method thereof, wherein the composition comprises the following materials in percentage by mass: 20-30% of vitamin C, 0.05-0.30% of vitamin B6, 2-6% of nicotinamide, 0.5-1.0% of calcium pantothenate, 0.60-1.90% of other vitamins and 60.80-76.85% of auxiliary materials, wherein the other vitamins are one or more of vitamin B2, folic acid and vitamin B12. In the formula, the B vitamins basically cover all vitamins of the B family, and the B vitamins are supplemented more comprehensively; the components which are mutually influenced are respectively granulated, and the contact is reduced, so that the stability of the preparation is obviously improved; the preparation process is simple and easy to implement, additional production equipment is not required, and the influence on the production cost is small.

Description

Composition for preventing and treating diseases caused by B vitamins and vitamin C deficiency and preparation method thereof
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a composition for preventing and treating diseases caused by deficiency of B vitamins and vitamin C and a preparation method thereof.
Background
At present, the market has more vitamin supplements, various single or compound preparations, the dosage forms are oral tablets, oral liquid and granules, the single vitamin supplement preparation can supplement the vitamin, the supplemented vitamin is not comprehensive enough, the existing compound vitamin supplement preparation can supplement vitamin C and more comprehensive B vitamins simultaneously, and the compound vitamin has the problems of multiple components, mutual influence and poor stability.
Disclosure of Invention
In view of the above, the main objective of the present invention is to provide a composition for preventing and treating diseases caused by B vitamins and vitamin C deficiency and a preparation method thereof.
In order to achieve the purpose, the technical scheme of the invention is realized as follows:
the embodiment of the invention provides a composition for preventing and treating diseases caused by B vitamins and vitamin C deficiency, which comprises the following materials in percentage by mass: 20-30% of vitamin C, 0.05-0.30% of vitamin B6, 2-6% of nicotinamide, 0.5-1.0% of calcium pantothenate, 0.60-1.90% of other vitamins and 60.80-76.85% of auxiliary materials, wherein the other vitamins are one or more of vitamin B2, folic acid and vitamin B12.
In the scheme, the auxiliary materials adopt 50-65% of filling agent, 0-10% of sweetening agent, 0-2% of flavoring agent and 0-5% of adhesive; wherein the filler is one or more of dextrin, starch, sucrose, lactose or microcrystalline cellulose, the sweetener is one or more of sucralose, aspartame or stevioside, and the correctant is one of sweet orange essence, pineapple essence and mango essence; the adhesive is polyvinylpyrrolidone K25 and polyvinylpyrrolidone K30, and the solvent of the adhesive is dissolved by 60-80% ethanol solution.
The embodiment of the invention also provides a preparation method of the composition for preventing and treating diseases caused by deficiency of B vitamins and vitamin C, the composition is granules, partial raw materials and auxiliary materials are weighed according to mass percent, the raw materials and the auxiliary materials are mixed in an equivalent incremental manner and granulated, wet granules obtained by granulation are dried to obtain first partial granules, other raw materials and the auxiliary materials are weighed according to mass percent, the raw materials and the auxiliary materials are mixed in an equivalent incremental manner and granulated, wet granules obtained by granulation are dried to obtain second partial granules, and the first partial granules and the second partial granules are uniformly mixed.
In the scheme, the preparation method specifically comprises the following steps: weighing 25% of vitamin C, 0.75% of vitamin B1, 0.00025% of vitamin B12, 0.025% of folic acid and 54.468% of auxiliary materials according to mass percent, mixing in an equivalent increasing manner, granulating, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.75% of vitamin B2, 0.2% of vitamin B6, 3% of nicotinamide, 1.0% of calcium pantothenate and 14.807% of auxiliary materials according to mass percent, mixing in an equivalent increasing manner, granulating, drying wet granules obtained by granulation to obtain a second part of granules.
In the scheme, the preparation method specifically comprises the following steps: weighing 30% of vitamin C, 0.75% of vitamin B1, 0.6% of vitamin B2, 0.2% of vitamin B6 and 49.829% of auxiliary materials according to mass percent, carrying out equivalent progressive mixing and granulation, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.15% of vitamin B2, 0.00025% of vitamin B12, 0.025% of folic acid, 5% of nicotinamide, 0.9% of calcium pantothenate and 12.546% of auxiliary materials according to mass percent, carrying out equivalent progressive mixing and granulation, and drying wet granules obtained by granulation to obtain a second part of granules.
In the scheme, the preparation method specifically comprises the following steps: weighing 27% of vitamin C, 0.75% of vitamin B1, 0.6% of vitamin B2 and 52.468% of auxiliary materials according to mass percentage, mixing and granulating in an equivalent increasing mode, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.15% of vitamin B2, 0.1% of vitamin B6, 0.00025% of vitamin B12, 0.025% of folic acid, 5% of nicotinamide, 0.9% of calcium pantothenate and 13.059% of auxiliary materials according to mass percentage, mixing and granulating in an equivalent increasing mode, and drying wet granules obtained by granulation to obtain a second part of granules.
In the scheme, the preparation method specifically comprises the following steps: weighing 20% of vitamin C, 0.65% of vitamin B1, 0.6% of vitamin B2, 0.15% of vitamin B6, 0.00025% of vitamin B12, 5% of nicotinamide, 0.025% of folic acid and 59.618% of auxiliary material according to mass percent, mixing in an equivalent progressive manner, granulating, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.15% of vitamin B2, 0.9% of calcium pantothenate and 12.959% of auxiliary material according to mass percent, mixing in an equivalent progressive manner, granulating, drying wet granules obtained by granulation to obtain a second part of granules.
In the scheme, the preparation method specifically comprises the following steps: weighing 25% of vitamin C, 0.75% of vitamin B1, 0.6% of vitamin B2, 0.2% of vitamin B6, 0.00025% of vitamin B12, 0.025% of folic acid and 54.881% of auxiliary material according to mass percent, mixing in an equivalent increasing manner and granulating, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.15% of vitamin B2, 0.9% of calcium pantothenate, 5% of nicotinamide and 12.494% of auxiliary material according to mass percent, mixing in an equivalent increasing manner and granulating, drying wet granules obtained by granulation to obtain a second part of granules.
Compared with the prior art, the B vitamins in the formula basically cover all vitamins of the B family, and the B vitamins are supplemented more comprehensively; in the preparation and placement processes of the multivitamin preparation, as the multivitamin preparation contains more components, the components are mutually influenced to cause unstable factors, and the components mutually influenced are respectively granulated by adopting a separate granulating mode to reduce contact, so that the stability of the preparation is obviously improved; the preparation process is simple and easy to implement, additional production equipment is not required, and the influence on the production cost is small.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
It should be noted that, in this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other like elements in a process, article, or apparatus that comprises the element.
The embodiment of the invention provides a composition for preventing and treating diseases caused by B vitamins and vitamin C deficiency, which comprises the following materials in percentage by mass: 20-30% of vitamin C, 0.05-0.30% of vitamin B6, 2-6% of nicotinamide, 0.5-1.0% of calcium pantothenate, 0.60-1.90% of other vitamins and 60.80-76.85% of auxiliary materials, wherein the other vitamins are one or more of vitamin B2, folic acid and vitamin B12.
The auxiliary materials comprise 50-65% of filling agent, 0-10% of sweetening agent, 0-2% of flavoring agent and 0-5% of adhesive; wherein the filler is one or more of dextrin, starch, sucrose, lactose or microcrystalline cellulose, the sweetener is one or more of sucralose, aspartame or stevioside, and the correctant is one of sweet orange essence, pineapple essence and mango essence; the adhesive is polyvinylpyrrolidone K25 and polyvinylpyrrolidone K30, and the solvent of the adhesive is dissolved by 60-80% ethanol solution.
The embodiment of the invention also provides a preparation method of the composition for preventing and treating diseases caused by deficiency of B vitamins and vitamin C, the composition is granules, partial raw materials and auxiliary materials are weighed according to mass percent, the raw materials and the auxiliary materials are mixed in an equivalent incremental manner and granulated, wet granules obtained by granulation are dried to obtain first partial granules, other raw materials and the auxiliary materials are weighed according to mass percent, the raw materials and the auxiliary materials are mixed in an equivalent incremental manner and granulated, wet granules obtained by granulation are dried to obtain second partial granules, and the first partial granules and the second partial granules are uniformly mixed.
The granulation specifically comprises the following steps: after the corresponding raw and auxiliary materials are mixed uniformly, the raw and auxiliary material materials are put into a granulating pot to be mixed, and then the adhesive solution is added for granulation. And (5) sieving the soft material after discharging, and finishing the granules by a 14-mesh sieve.
The drying specifically comprises the following steps: drying wet granules by using a forced air drying oven or a boiling granulator at the drying temperature of 60 ℃ for more than 30 minutes, and sieving the granules by using a 12-mesh sieve to complete the granules after drying, wherein the drying weight loss of dry granules is not more than 3%.
The embodiment 1 of the invention provides a preparation method of a composition for preventing and treating diseases caused by deficiency of vitamin B complex and vitamin C, the composition is granules, and the composition is prepared by weighing 20% of vitamin C, 0.75% of vitamin B1, 0.50% of vitamin B2, 0.2% of vitamin B6, 0.0005% of vitamin B12, 4% of nicotinamide, 1.0% of calcium pantothenate, 0.02% of folic acid and 73.53% of auxiliary materials according to mass percentage.
Equal amounts were incrementally mixed and granulated, and the wet granules obtained from granulation were dried to obtain granules.
The auxiliary materials adopt 15% of dextrin, 55.83% of cane sugar and 2.70% of aspartame.
The embodiment 2 of the invention provides a preparation method of a composition for preventing and treating diseases caused by deficiency of B vitamins and vitamin C, the composition is granules, and the composition is prepared by weighing 20% of vitamin C, 0.75% of vitamin B1, 0.50% of vitamin B2, 0.2% of vitamin B6, 0.0005% of vitamin B12, 4% of nicotinamide, 1.0% of calcium pantothenate, 0.02% of folic acid and 73.53% of auxiliary materials according to mass percentage. Equal amounts were incrementally mixed and granulated, and the wet granules obtained from granulation were dried to obtain granules.
The auxiliary materials comprise 13.25% of dextrin, 55.83% of cane sugar and 2.70% of aspartame. And 1.75% of sweet orange essence.
Embodiment 3 of the present invention provides a method for preparing a composition for preventing and treating diseases caused by B-group vitamins and vitamin C deficiency, which is characterized in that the composition is a granule, 25% by mass of vitamin C, 0.75% by mass of vitamin B1, 0.00025% by mass of vitamin B12, 0.025% by mass of folic acid, and 54.468% by mass of an auxiliary material are weighed, mixed in an equal amount and in an increasing order, and granulated, a first part of granules are obtained after drying wet granules obtained by granulation, a second part of granules are obtained after drying wet granules obtained by granulation and in an equal amount and in an increasing order, 0.75% by mass of vitamin B2, 0.2% by mass of vitamin B6, 3% by mass of nicotinamide, 1.0% by mass of calcium pantothenate, and 14.807% by mass of auxiliary material are weighed, mixed in an increasing order, and granulated, and the wet granules obtained by granulation are dried to obtain a second part of granules. And (3) putting the first part of granules and the second part of granules into a three-dimensional mixer, and mixing for 30 minutes to obtain the product.
The auxiliary materials comprise 10% of dextrin, 25.835% of lactose, 25% of microcrystalline cellulose, 1.54% of aspartame and 255% of polyvinylpyrrolidone K (dissolved by using 75% of ethanol).
Embodiment 4 of the present invention provides a method for preparing a composition for preventing and treating diseases caused by B-group vitamins and vitamin C deficiency, the composition is a granule, 30% of vitamin C, 0.75% of vitamin B1, 0.6% of vitamin B2, 0.2% of vitamin B6, and 49.829% of auxiliary materials are weighed according to mass percentage, and are mixed in an equivalent incremental manner and granulated, a first part of granules are obtained after drying wet granules obtained by granulation, a second part of granules are obtained after drying wet granules obtained by granulation, 0.15% of vitamin B2, 0.00025% of vitamin B12, 0.025% of folic acid, 5% of nicotinamide, 0.9% of calcium pantothenate, and 0. 12.546% of auxiliary materials are weighed in mass percentage, and are mixed in an equivalent incremental manner and granulated, and the wet granules obtained by granulation are dried to obtain a second part of granules. And (3) putting the first part of granules and the second part of granules into a three-dimensional mixer, and mixing for 30 minutes to obtain the product.
The auxiliary materials comprise 10% of dextrin, 20% of microcrystalline cellulose, 30.835% of sucrose, 1.54% of aspartame and 305% of polyvinylpyrrolidone K (dissolved by using 75% of ethanol).
Embodiment 5 of the present invention provides a method for preparing a composition for preventing and treating diseases caused by B-group vitamins and vitamin C deficiency, which is characterized in that the composition is a granule, 27% by mass of vitamin C, 0.75% by mass of vitamin B1, 0.6% by mass of vitamin B2, and 52.468% by mass of an auxiliary material are weighed, mixed and granulated incrementally in equal amounts, a first portion of granules are obtained after drying wet granules obtained by granulation, 0.15% by mass of vitamin B2, 0.1% by mass of vitamin B6, 0.00025% by mass of vitamin B12, 0.025% by mass of folic acid, 5% by mass of nicotinamide, 0.9% by mass of calcium pantothenate, and 13.059% by mass of auxiliary material are weighed, mixed and granulated incrementally in equal amounts, and the wet granules obtained by granulation are dried to obtain a second portion of granules. And (3) putting the first part of granules and the second part of granules into a three-dimensional mixer, and mixing for 30 minutes to obtain the product.
The auxiliary materials comprise 10% of dextrin, 20% of microcrystalline cellulose, 35.835% of cane sugar and 1.54% of aspartame.
Embodiment 6 of the present invention provides a method for preparing a composition for preventing and treating diseases caused by B-group vitamins and vitamin C deficiency, which is characterized in that the composition is a granule, 20% of vitamin C, 0.65% of vitamin B1, 0.6% of vitamin B2, 0.15% of vitamin B6, 0.00025% of vitamin B12, 5% of nicotinamide, 0.025% of folic acid, and 59.618% of an auxiliary material are weighed according to mass percentage, mixed in an equivalent and incremental manner and granulated, a first part of granules are obtained after drying wet granules obtained by granulation, a second part of granules are obtained after drying wet granules obtained by granulation, 0.15% of vitamin B2, 0.9% of calcium pantothenate, and 12.959% of an auxiliary material. And (3) putting the first part of granules and the second part of granules into a three-dimensional mixer, and mixing for 30 minutes to obtain the product.
The auxiliary materials comprise 10% of starch, 55.835% of cane sugar and 1.54% of sucralose.
Embodiment 7 of the present invention provides a preparation method of a composition for preventing and treating diseases caused by B vitamins and vitamin C deficiency, which is characterized in that the composition is a granule, 20% of vitamin C, 0.75% of vitamin B1, 0.40% of vitamin B2, 0.2% of vitamin B6, 0.0005% of vitamin B12, 0.02% of folic acid and 50.287 are weighed according to mass percentage, and are mixed in an equivalent incremental manner and granulated, a first part of granules are obtained after wet granules obtained by granulation are dried, a second part of granules are obtained after wet granules obtained by granulation are dried, and 0.10% of vitamin B2, 1.0% of calcium pantothenate, 4% of nicotinamide and 23.243% of auxiliary materials are weighed according to mass percentage. And (3) putting the first part of granules and the second part of granules into a three-dimensional mixer, and mixing for 30 minutes to obtain the product.
The auxiliary materials adopt 5 percent of dextrin, 55.83 percent of cane sugar and 2.70 percent of aspartame.
Embodiment 8 of the present invention provides a method for preparing a composition for preventing and treating diseases caused by B-group vitamins and vitamin C deficiency, the composition is a granule, 20% of vitamin C, 0.75% of vitamin B1, 0.40% of vitamin B2, 0.2% of vitamin B6, 0.0005% of vitamin B12, 0.02% of folic acid, and 50.287% are weighed according to mass percentage, mixed in an equivalent increasing manner and granulated, a wet granule obtained by granulation is dried to obtain a first part granule, 0.10% of vitamin B2, 1.0% of calcium pantothenate, 4% of nicotinamide, and 23.243% of auxiliary material are weighed according to mass percentage, and a wet granule obtained by granulation is dried to obtain a second part granule. And (3) putting the first part of granules and the second part of granules into a three-dimensional mixer, and mixing for 30 minutes to obtain the product.
The auxiliary materials comprise 13.25% of dextrin, 55.83% of cane sugar, 2.70% of aspartame and 1.75% of orange essence.
The stability test was performed on the pellets prepared in examples 1-8, each pellet was weighed into an aluminum foil pouch, sealed and placed in a stability test box under the following high temperature conditions: 60 ℃, and the accelerating conditions are as follows: 40 ℃ and RH 75%. The results are as follows:
standing at 60 deg.C for 10 days
Calcium pantothenate Nicotinamide B6 B2 B1 VC
Example 1 -50.83% 0.05% -1.40% 1.41% -7.63% 2.58%
Example 2 -62.96% 0.06% -2.89% 8.48% -2.71% 0.78%
Example 3 -25.62% 2.18% -4.62% -3.00% -4.09% -0.48%
Example 4 -22.42% 6.34% -3.14% 1.68% -4.98% -1.56%
Example 5 -23.56% 0.74% -6.78% -5.06% -3.23% 2.07%
Example 6 -21.97% 3.51% 5.10% -1.27% -3.74% 2.88%
Example 7 -14.98% -0.24% 6.10% -4.18% -2.33% 1.62%
Example 8 -20.26% -1.62% -3.28% -2.32% -3.24% 2.14%
Accelerated standing for 10 days
Figure BDA0003542445360000081
Figure BDA0003542445360000091
Wherein, the examples 1 and 2 are conventional preparation processes, the calcium pantothenate content is reduced to below 50% after standing for 10 days under high temperature condition, and the calcium pantothenate content is reduced by more than 20% after standing for 10 days under accelerated condition.
Examples 3-8 are the present preparation process, and the calcium pantothenate content was reduced by no more than 25% from the labeled amount after standing at high temperature for 10 days, and was not significantly changed (no more than 5% from the labeled amount) after standing at accelerated conditions for 10 days.
The high temperature stability test and the accelerated stability test are both carried out under the ultra-conventional condition, and the purpose is to discuss the stability of the medicament by accelerating the chemical and/or physical change of the medicament and provide necessary information for the packaging, transportation and storage of products. From the stability test results of the examples, the stability of the samples of examples 3-8 is significantly better than that of examples 1 and 2 under high temperature conditions, and under accelerated conditions, the stability of examples 7 and 8 is also better than that of examples 1 and 2, with no significant change in the standing time. From the results, it can be judged that the sample of the present invention has better stability and longer shelf life than the conventional product under the conventional storage conditions.
The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention.

Claims (8)

1. The composition for preventing and treating diseases caused by deficiency of B vitamins and vitamin C is characterized by comprising the following materials in percentage by mass: 20-30% of vitamin C, 0.05-0.30% of vitamin B6, 2-6% of nicotinamide, 0.5-1.0% of calcium pantothenate, 0.60-1.90% of other vitamins and 60.80-76.85% of auxiliary materials, wherein the other vitamins are one or more of vitamin B2, folic acid and vitamin B12.
2. The composition for preventing and treating diseases caused by vitamin B and vitamin C deficiency as claimed in claim 1, wherein the adjuvant comprises 50-65% of bulking agent, 0-10% of sweetening agent, 0-2% of flavoring agent and 0-5% of binding agent; wherein the filler is one or more of dextrin, starch, sucrose, lactose or microcrystalline cellulose, the sweetener is one or more of sucralose, aspartame or stevioside, and the correctant is one of sweet orange essence, pineapple essence and mango essence; the adhesive is polyvinylpyrrolidone K25 and polyvinylpyrrolidone K30, and the solvent of the adhesive is dissolved by 60-80% ethanol solution.
3. A preparation method of a composition for preventing and treating diseases caused by deficiency of B vitamins and vitamin C is characterized in that the composition is a granule, partial raw materials and auxiliary materials are weighed according to mass percentage, the raw materials and the auxiliary materials are mixed in an equivalent incremental manner and granulated, a first part of granules are obtained after wet granules obtained by granulation are dried, other raw materials and the auxiliary materials are weighed according to mass percentage, the raw materials and the auxiliary materials are mixed in an equivalent incremental manner and granulated, a second part of granules are obtained after the wet granules obtained by granulation are dried, and the first part of granules and the second part of granules are uniformly mixed.
4. The method of claim 3, wherein the method comprises the steps of: weighing 25% of vitamin C, 0.75% of vitamin B1, 0.00025% of vitamin B12, 0.025% of folic acid and 54.468% of auxiliary materials according to mass percent, mixing in an equivalent increasing manner, granulating, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.75% of vitamin B2, 0.2% of vitamin B6, 3% of nicotinamide, 1.0% of calcium pantothenate and 14.807% of auxiliary materials according to mass percent, mixing in an equivalent increasing manner, granulating, drying wet granules obtained by granulation to obtain a second part of granules.
5. The method for preparing the composition for preventing and treating diseases caused by vitamin B and vitamin C deficiency according to claim 3, wherein the preparation method comprises the following steps: weighing 30% of vitamin C, 0.75% of vitamin B1, 0.6% of vitamin B2, 0.2% of vitamin B6 and 49.829% of auxiliary materials according to mass percent, carrying out equivalent progressive mixing and granulation, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.15% of vitamin B2, 0.00025% of vitamin B12, 0.025% of folic acid, 5% of nicotinamide, 0.9% of calcium pantothenate and 12.546% of auxiliary materials according to mass percent, carrying out equivalent progressive mixing and granulation, and drying wet granules obtained by granulation to obtain a second part of granules.
6. The method of claim 3, wherein the method comprises the steps of: weighing 27% of vitamin C, 0.75% of vitamin B1, 0.6% of vitamin B2 and 52.468% of auxiliary materials according to mass percentage, mixing and granulating in an equivalent increasing mode, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.15% of vitamin B2, 0.1% of vitamin B6, 0.00025% of vitamin B12, 0.025% of folic acid, 5% of nicotinamide, 0.9% of calcium pantothenate and 13.059% of auxiliary materials according to mass percentage, mixing and granulating in an equivalent increasing mode, and drying wet granules obtained by granulation to obtain a second part of granules.
7. The method of claim 3, wherein the method comprises the steps of: weighing 20% of vitamin C, 0.65% of vitamin B1, 0.6% of vitamin B2, 0.15% of vitamin B6, 0.00025% of vitamin B12, 5% of nicotinamide, 0.025% of folic acid and 59.618% of auxiliary material according to mass percent, mixing in an equivalent progressive manner, granulating, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.15% of vitamin B2, 0.9% of calcium pantothenate and 12.959% of auxiliary material according to mass percent, mixing in an equivalent progressive manner, granulating, drying wet granules obtained by granulation to obtain a second part of granules.
8. The method of claim 3, wherein the method comprises the steps of: weighing 25% of vitamin C, 0.75% of vitamin B1, 0.6% of vitamin B2, 0.2% of vitamin B6, 0.00025% of vitamin B12, 0.025% of folic acid and 54.881% of auxiliary material according to mass percent, mixing in an equivalent increasing manner and granulating, drying wet granules obtained by granulation to obtain a first part of granules, weighing 0.15% of vitamin B2, 0.9% of calcium pantothenate, 5% of nicotinamide and 12.494% of auxiliary material according to mass percent, mixing in an equivalent increasing manner and granulating, drying wet granules obtained by granulation to obtain a second part of granules.
CN202210236536.8A 2022-03-11 2022-03-11 Composition for preventing and treating diseases caused by B vitamins and vitamin C deficiency and preparation method thereof Pending CN114617901A (en)

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CN103340891A (en) * 2013-06-08 2013-10-09 哈尔滨珍宝制药有限公司 B vitamins containing composition and preparation method thereof
CN103432155A (en) * 2013-08-28 2013-12-11 葵花药业集团(衡水)得菲尔有限公司 Production technology of particle comprising ten vitamins for children
CN107969704A (en) * 2017-12-07 2018-05-01 山东禹王制药有限公司 A kind of vitamin premix of suitable soft capsule preparation and preparation method thereof

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CN103340891A (en) * 2013-06-08 2013-10-09 哈尔滨珍宝制药有限公司 B vitamins containing composition and preparation method thereof
CN103432155A (en) * 2013-08-28 2013-12-11 葵花药业集团(衡水)得菲尔有限公司 Production technology of particle comprising ten vitamins for children
CN107969704A (en) * 2017-12-07 2018-05-01 山东禹王制药有限公司 A kind of vitamin premix of suitable soft capsule preparation and preparation method thereof

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