CN109662953B - Vitamin D soft capsule and preparation method thereof - Google Patents

Vitamin D soft capsule and preparation method thereof Download PDF

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CN109662953B
CN109662953B CN201910119036.4A CN201910119036A CN109662953B CN 109662953 B CN109662953 B CN 109662953B CN 201910119036 A CN201910119036 A CN 201910119036A CN 109662953 B CN109662953 B CN 109662953B
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vitamin
capsule
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CN109662953A (en
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林云
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Weihai Jinsili Biotechnology Co ltd
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
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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
    • A61K31/59Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/5939,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • 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 vitamin D soft capsule and a preparation method thereof, wherein the vitamin D soft capsule comprises the following substances in parts by mass: 400-625 parts of calcium carbonate; vitamin D30.001 to 0.005 part; 225-550 parts of soybean oil; 425-650 parts of gelatin; 450-700 parts of purified water; 110-325 parts of glycerol; 100-400 parts of glycerin monostearate; 0.01-0.02 part of titanium dioxide; 100-200 parts of corn oil; 0.05-0.2 part of dibutyl hydroxy toluene. The preparation method of the soft capsule comprises the following steps: preparing capsule content; manufacturing mucilage; making a soft capsule comprising capsule contents; and (4) processing the vitamin D soft capsule after preparation. The additive is less, and anaphylactic reaction or other discomfort caused by the additive can be avoided; the content of the capsule is more uniformly and stably mixed, and the phenomena of oil layer separation, calcium carbonate precipitation and the like can not occur; the capsule shell of the soft capsule has water locking effect.

Description

Vitamin D soft capsule and preparation method thereof
Technical Field
The invention relates to a soft capsule and a preparation method thereof, in particular to a vitamin D soft capsule and a preparation method thereof.
Background
Vitamin D is a fat-soluble vitamin necessary for human, is one of important regulating factors of calcium and phosphorus metabolism, can promote the absorption of calcium and phosphorus elements by human bodies, maintain the normal blood calcium and phosphorus levels of the human bodies, and participate in the life processes of differentiation and proliferation of a plurality of histiocytes and the like. The most important of the currently known vitamin D is vitamin D2(ergocalciferol) and vitamin D3(cholecalciferol aldehyde). Vitamin D2Is produced by ergosterol in plants irradiated with ultraviolet rays, but is present in a small amount in the natural world. Vitamin D3The product is obtained by converting 7-dehydrocholesterol contained in human epidermis and dermis by ultraviolet irradiation in sunlight. Vitamin D2And vitamin D3The action and action mechanism of the vitamin D are completely the same, the utilization of mammals and human beings is not different, and two types of common vitamin D exist, wherein the vitamin D is vitamin D2Is calciferol, vitamin D3Is cholecalciferol. Whether vitamin D2Is also vitamin D3The product is inactive, and needs to be converted into 1, 25-dihydroxy vitamin D twice by liver and kidney cells2And can promote the absorption of calcium and phosphorus in small intestine. When vitamin D is deficient, the capability of human body to absorb calcium and phosphorus is reduced, the level of calcium and phosphorus in blood is low, the osteogenesis effect is hindered, and the osteohaline redissolution even occurs, namely rickets in children and osteomalacia in adults. Therefore, people often take vitamin D and calcium together to ensure the calcium supplement effect.
At present, products for supplementing calcium and vitamins in the market are more and more complex in category, but the aim of improving the content of active ingredients of the products and promoting the absorption of a human body is generally achieved, the freshness of a capsule shell and the uniformity of the content are improved, some people are used to cut a soft capsule to only take the content of the soft capsule when taking soft capsule health-care products, so that higher requirements are provided for the manufacturing process of the soft capsule, when the soft capsule with unstable fusion of the content of the soft capsule is taken by the method, only oil can be extruded from the soft capsule, particularly the soft capsule taking calcium carbonate as a raw material is easy to precipitate, the precipitated calcium carbonate is adhered to the capsule shell and is difficult to be extruded together with the oil, and therefore the calcium cannot be absorbed by the human body.
Disclosure of Invention
In order to solve the defects of the technology, the invention provides a vitamin D soft capsule and a preparation method thereof.
In order to solve the technical problems, the invention adopts the technical scheme that: a vitamin D soft capsule is composed of the following substances in parts by mass:
400-625 parts of calcium carbonate; vitamin D30.001 to 0.005 part;
225-550 parts of soybean oil; 425-650 parts of gelatin;
450-700 parts of purified water; 110-325 parts of glycerol;
100-400 parts of glycerin monostearate; 0.01-0.02 part of titanium dioxide;
100-200 parts of corn oil; 0.05-0.2 part of dibutyl hydroxy toluene.
A method for preparing vitamin D soft capsules comprises the following steps:
a. preparing capsule content; mixing carbonGrinding the calcium carbonate solid into calcium carbonate powder which can pass through a 200-mesh sieve, and uniformly mixing the calcium carbonate powder with the soybean oil by a colloid mill to obtain a calcium agent; mixing vitamin D3Adding into corn oil, mechanically stirring, and continuously adding dibutyl hydroxy toluene while stirring, wherein the amount of added dibutyl hydroxy toluene is 2/3 of total amount of dibutyl hydroxy toluene, and the rest 1/3 of dibutyl hydroxy toluene is used; continuously stirring for 1-2 minutes, introducing into a colloid mill, and uniformly grinding to obtain the vitamin agent; grinding and mixing the calcium agent, the vitamin agent and 1/3 glyceryl monostearate by a colloid mill to obtain uniform capsule contents;
b. manufacturing mucilage; heating purified water at room temperature, and dissolving glycerol in the purified water during heating to form glycerol aqueous solution; when the temperature of the glycerin water solution is raised to 55 ℃, gelatin is added and slowly stirred to accelerate the dissolution of the gelatin to prepare gelatin water; sequentially adding the titanium dioxide, the 1/3 dibutyl hydroxy toluene remained in the step a and 2/3 glyceryl monostearate into gelatin water, and uniformly grinding the materials by a colloid mill to obtain a mucilage;
c. making a soft capsule containing the capsule contents; b, putting the content of the capsule prepared in the step a into an oil hopper of a pill dropping machine, putting the mucilage prepared in the step b into a glue hopper, arranging a cooling cup below an outlet of a concentric tube of the pill dropping machine, and pouring a coolant into the cooling cup; setting a pill dropping machine to enable the content of a capsule in each pill to be 1000 mg, after the pill dropping machine is started, dropping the mucilage from an outlet of a concentric tube before the content of the capsule, dropping the mucilage onto the upper surface of a coolant and unfolding to form a rubber, dropping the content of the capsule onto the surface of the rubber which is just unfolded immediately, wherein the rubber sinks in the coolant continuously due to the acceleration of gravity, the rubber is completely sealed under the action of molecular force of the coolant, the content of the capsule is wrapped in the rubber, and the rubber is made into a spherical shape under the action of surface tension, so that the rubber is gradually solidified due to the gradual reduction of the temperature of the coolant along with the sinking of the rubber, and the soft capsule containing the content of the capsule is prepared;
d. processing the vitamin D soft capsule after preparation; and D, fishing out the soft capsule containing the capsule content prepared in the step c from the coolant, primarily drying the soft capsule in cold air at room temperature, washing the soft capsule after drying until no obvious coolant water stain residue exists, firstly washing the soft capsule with petroleum ether twice, then washing the soft capsule in ethanol with the concentration of 95%, and drying the soft capsule for 8-12 hours at the temperature of 30-35 ℃ to finish the whole process of preparing the vitamin D soft capsule.
Further, the coolant is liquid paraffin or vegetable oil; the temperature of the coolant is 10-15 ℃.
The invention has simple components and less additives, and can avoid anaphylactic reaction or other discomfort caused by excessive additives; the capsule content is more uniformly and stably mixed, the phenomena of oil layer separation, calcium carbonate precipitation and the like can not occur, calcium carbonate or vitamin D can not remain in the capsule shell even if the content is extruded for eating, and the intake of effective components can not be reduced; the capsule shell of the soft capsule has a good water locking effect, and experiments prove that the soft capsule can keep elastic freshness for two months even if exposed to flowing and dry air, and is generally stored in a bottle with a cover during daily taking, so that the hard shell phenomenon can not occur even if the soft capsule is taken for a long time, and the taking taste is improved.
Detailed Description
The present invention will be described in further detail with reference to specific embodiments.
The vitamin D soft capsule consists of the following substances in parts by mass:
400-625 parts of calcium carbonate; vitamin D30.001 to 0.005 part;
225-550 parts of soybean oil; 425-650 parts of gelatin;
450-700 parts of purified water; 110-325 parts of glycerol;
100-400 parts of glycerin monostearate; 0.01-0.02 part of titanium dioxide;
100-200 parts of corn oil; 0.05-0.2 part of dibutyl hydroxy toluene.
A method for preparing vitamin D soft capsules comprises the following steps:
a. preparing capsule content; grinding the calcium carbonate solids to a carbon that can pass through a 200 mesh screenCalcium carbonate powder and soybean oil are uniformly mixed by a colloid mill to prepare a calcium agent; mixing vitamin D3Adding into corn oil, mechanically stirring, and continuously adding dibutyl hydroxy toluene while stirring, wherein the amount of added dibutyl hydroxy toluene is 2/3 of total amount of dibutyl hydroxy toluene, and the rest 1/3 of dibutyl hydroxy toluene is used; continuously stirring for 1-2 minutes, introducing into a colloid mill, and uniformly grinding to obtain the vitamin agent; grinding and mixing the calcium agent, the vitamin agent and 1/3 glyceryl monostearate by a colloid mill to obtain uniform capsule contents;
b. manufacturing mucilage; heating purified water at room temperature, and dissolving glycerol in the purified water during heating to form glycerol aqueous solution; when the temperature of the glycerin water solution is raised to 55 ℃, gelatin is added and slowly stirred to accelerate the dissolution of the gelatin to prepare gelatin water; sequentially adding the titanium dioxide, the 1/3 dibutyl hydroxy toluene remained in the step a and 2/3 glyceryl monostearate into gelatin water, and uniformly grinding the materials by a colloid mill to obtain a mucilage;
c. making a soft capsule comprising capsule contents; putting the content of the capsule prepared in the step a into an oil hopper of a pill dropping machine, putting the mucilage prepared in the step b into a glue hopper, arranging a cooling cup below an outlet of a concentric tube of the pill dropping machine, pouring a cooling agent into the cooling cup, wherein the cooling agent is liquid paraffin or vegetable oil, and the temperature of the cooling agent is 10-15 ℃; setting a pill dropping machine to enable the content of a capsule in each pill to be 1000 mg, after the pill dropping machine is started, dropping the mucilage from an outlet of a concentric tube before the content of the capsule, dropping the mucilage onto the upper surface of a coolant and unfolding to form a rubber, dropping the content of the capsule onto the surface of the rubber which is just unfolded immediately, wherein the rubber sinks in the coolant continuously due to the acceleration of gravity, the rubber is completely sealed under the action of molecular force of the coolant, the content of the capsule is wrapped in the rubber, and the rubber is made into a spherical shape under the action of surface tension, so that the rubber is gradually solidified due to the gradual reduction of the temperature of the coolant along with the sinking of the rubber, and the soft capsule containing the content of the capsule is prepared;
d. processing the vitamin D soft capsule after preparation; and D, fishing out the soft capsule containing the capsule content prepared in the step c from the coolant, primarily drying the soft capsule in cold air at room temperature, washing the soft capsule after drying until no obvious coolant water stain residue exists, firstly washing the soft capsule with petroleum ether twice, then washing the soft capsule in ethanol with the concentration of 95%, and drying the soft capsule for 8-12 hours at the temperature of 30-35 ℃ to finish the whole process of preparing the vitamin D soft capsule.
Wherein, the calcium content in the calcium carbonate is the highest in all the calcium-containing compounds, and the calcium carbonate is suitable for supplementing calcium for human bodies; vitamin D3Is a main substance for supplementing vitamin D to human body, and is difficult to synthesize enough vitamin D for people who do not contact with sunlight frequently3For self-demand, and therefore oral administration of vitamin D is required3
The corn oil contains rich diene aldehyde compounds, palmitic acid, squalene, stearic acid, oleic acid and linoleic acid, has outstanding oxidation resistance compared with soybean oil, fish oil, camellia oil and the like, and the oxidation resistance component in the corn oil can prevent the oxidation and acidification of oil in the soft capsule which is placed for a long time, so that the capsule shell of the soft capsule and the vitamin D nutrient component in the soft capsule are protected.
The structure of the glyceryl monostearate has an oleophylic long-chain alkyl group and two hydrophilic hydroxyl groups, the glyceryl monostearate in the capsule contents can promote the fusion between soybean oil and corn oil, the soybean oil is used as a calcium carbonate dispersing carrier, the corn oil is used as a vitamin D dispersing carrier, the two dispersing carriers are uniformly fused by the glyceryl monostearate, the fusion stability is improved, and even if the capsule contents are placed for a long time in the production process or after being made into soft capsules, the uniform stability of the capsule contents can be ensured, the phenomena of calcium carbonate sedimentation, oil layer separation and the like can be avoided, and the storage life of the vitamin D soft capsules can be prolonged.
The characteristics and the effects of the vitamin D soft capsules are mainly maintained. The main component of the soft capsule shell is gelatin which can be dissolved in glycerol, but the soft capsule shell can be dehydrated and hardened after being placed in a dry environment or an environment with poor sealing property for a long time, so that the hardened soft capsule shell can reduce the taste of the soft capsule shell and bring an stale feeling to people. After the glycerin monostearate is added into the capsule shell, the hardening condition of the capsule shell can be obviously improved, and the freshness period of the capsule shell of the soft capsule is prolonged; the dibutyl hydroxy toluene has good oxidation resistance, and the dibutyl hydroxy toluene added into the soft capsule contents can further prevent oxidation and acidification of grease, so that the properties and the efficacy of the capsule contents are ensured; on the other hand, the capsule shell of the soft capsule is also added with the dibutylhydroxytoluene, so that the quality guarantee period of the capsule shell can be further prolonged, and the protection period of the content of the capsule shell can be effectively prolonged.
The technical scheme of the invention is explained in detail by the following specific embodiments:
the first embodiment,
The vitamin D soft capsule consists of the following substances in parts by mass:
400 parts of calcium carbonate; vitamin D30.005 part;
225 parts of soybean oil; 650 parts of gelatin;
450 parts of purified water; 325 parts of glycerol;
100 parts of glycerin monostearate; 0.02 part of titanium dioxide;
100 parts of corn oil; 0.2 part of butylated hydroxytoluene.
In this embodiment, the process for preparing the vitamin D soft capsule comprises:
a. preparing capsule content; grinding 400 parts of calcium carbonate solid into calcium carbonate powder which can pass through a 200-mesh sieve, and uniformly mixing the calcium carbonate powder with 225 parts of soybean oil by using a colloid mill to obtain a calcium agent; adding 0.005 part of vitamin D3Adding to 100 parts of corn oil, mechanically stirring, and continuously adding 0.133 part of dibutyl hydroxy toluene while stirring; continuously stirring for 1-2 minutes, introducing into a colloid mill, and uniformly grinding to obtain the vitamin agent; grinding and mixing the calcium agent, the vitamin agent and 33 parts of glyceryl monostearate by a colloid mill to obtain a uniform capsule content;
b. manufacturing mucilage; heating 450 parts of purified water at room temperature, and dissolving 325 parts of glycerol in the purified water during heating to form a glycerol aqueous solution; when the temperature of the glycerin water solution is raised to 55 ℃, 650 parts of gelatin is added and slowly stirred to accelerate the dissolution of the gelatin to prepare gelatin water; sequentially adding 0.02 part of titanium dioxide, 0.067 part of dibutyl hydroxy toluene remained in the step a and 67 parts of glyceryl monostearate into gelatin water, and uniformly grinding the materials by a colloid mill to obtain a mucilage;
c. making a soft capsule containing the capsule contents; putting the content of the capsule prepared in the step a into an oil hopper of a pill dropping machine, putting the mucilage prepared in the step b into a glue hopper, arranging a cooling cup below an outlet of a concentric tube of the pill dropping machine, pouring a coolant into the cooling cup, wherein the coolant is liquid paraffin or vegetable oil, and the temperature of the coolant is 10-15 ℃; setting a pill dropping machine to enable the content of a capsule in each pill to be 1000 mg, after the pill dropping machine is started, dropping the mucilage from an outlet of a concentric tube before the content of the capsule, dropping the mucilage onto the upper surface of a coolant and unfolding to form a rubber, dropping the content of the capsule onto the surface of the rubber which is just unfolded immediately, wherein the rubber sinks in the coolant continuously due to the acceleration of gravity, the rubber is completely sealed under the action of molecular force of the coolant, the content of the capsule is wrapped in the rubber, and the rubber is made into a spherical shape under the action of surface tension, so that the rubber is gradually solidified due to the gradual reduction of the temperature of the coolant along with the sinking of the rubber, and the soft capsule containing the content of the capsule is prepared;
d. processing the vitamin D soft capsule after preparation; and D, fishing out the soft capsule containing the capsule content prepared in the step c from the coolant, primarily drying the soft capsule in cold air at room temperature, washing the soft capsule after drying until no obvious coolant water stain residue exists, firstly washing the soft capsule with petroleum ether twice, then washing the soft capsule in ethanol with the concentration of 95%, and drying the soft capsule for 8-12 hours at the temperature of 30-35 ℃ to finish the whole process of preparing the vitamin D soft capsule.
The content of calcium in each vitamin D soft capsule prepared in this example was 211 mg, and the content of vitamin D was 6.5 μ g.
Example II,
The vitamin D soft capsule consists of the following substances in parts by mass:
625 parts of calcium carbonate; vitamin D30.001 part;
550 parts of soybean oil; 425 parts of gelatin;
700 parts of purified water; 110 parts of glycerol;
400 parts of glycerin monostearate; 0.01 part of titanium dioxide;
200 parts of corn oil; 0.05 part of butylated hydroxytoluene.
In this embodiment, the manufacturing process of the vitamin D soft capsule is different from that of the first embodiment in that: the amounts of the components added were varied, and the amount of dibutylhydroxytoluene added in step a was 0.033 parts and the amount of glyceryl monostearate was 134 parts, and the amount of dibutylhydroxytoluene added in step b was 0.017 parts and the amount of glyceryl monostearate was 266 parts.
The content of calcium in each vitamin D soft capsule prepared in this example was 165 mg, and the content of vitamin D was 0.7 μ g.
Example III,
The vitamin D soft capsule consists of the following substances in parts by mass:
450 parts of calcium carbonate; vitamin D30.002 part;
250 parts of soybean oil; 450 parts of gelatin;
500 parts of purified water; 150 parts of glycerol;
200 parts of glycerin monostearate; 0.015 part of titanium dioxide;
125 parts of corn oil; 0.1 part of butylated hydroxytoluene.
In this embodiment, the manufacturing process of the vitamin D soft capsule is different from that of the first embodiment in that: the amounts of the respective components added were varied, and the amount of dibutylhydroxytoluene added in step a was 0.067 parts and the amount of glyceryl monostearate was 67 parts, while the amount of dibutylhydroxytoluene added in step b was 0.033 parts and the amount of glyceryl monostearate was 133 parts.
The content of calcium in each vitamin D soft capsule prepared in this example is 216 mg, and the content of vitamin D is 2.4 μ g.
Example four,
The vitamin D soft capsule consists of the following substances in parts by mass:
500 parts of calcium carbonate; vitamin D30.003 part of a mixture;
300 parts of soybean oil; 500 parts of gelatin;
550 parts of purified water; 200 parts of glycerol;
300 parts of glycerin monostearate; 0.01 part of titanium dioxide;
150 parts of corn oil; 0.15 part of butylated hydroxytoluene.
In this embodiment, the manufacturing process of the vitamin D soft capsule is different from that of the first embodiment in that: the amounts of the components added were varied, and the amount of dibutylhydroxytoluene added in step a was 0.1 part and the amount of glyceryl monostearate was 100 parts, and the amount of dibutylhydroxytoluene added in step b was 0.05 part and the amount of glyceryl monostearate was 200 parts.
The content of calcium in each vitamin D soft capsule prepared in this example was 190 mg, and the content of vitamin D was 2.8 μ g.
Example V,
The vitamin D soft capsule consists of the following substances in parts by mass:
550 parts of calcium carbonate; vitamin D30.004 portion;
350 parts of soybean oil; 550 parts of gelatin;
600 parts of purified water; 250 parts of glycerol;
300 parts of glycerin monostearate; 0.02 part of titanium dioxide;
175 parts of corn oil; 0.2 part of butylated hydroxytoluene.
In this embodiment, the manufacturing process of the vitamin D soft capsule is different from that of the first embodiment in that: the amounts of the components added were varied, and the amounts of dibutylhydroxytoluene and glycerol monostearate added in step a were 0.134 parts and 100 parts, and the amounts of dibutylhydroxytoluene and glycerol monostearate added in step b were 0.066 parts and 200 parts, respectively.
The content of calcium in each vitamin D soft capsule prepared in this example was 187 mg, and the content of vitamin D was 3.4 μ g.
Example six,
The vitamin D soft capsule consists of the following substances in parts by mass:
600 parts of calcium carbonate; vitamin D30.002 part;
400 parts of soybean oil; 600 parts of gelatin;
650 parts of purified water; 300 parts of glycerol;
200 parts of glycerin monostearate; 0.015 part of titanium dioxide;
150 parts of corn oil; 0.1 part of butylated hydroxytoluene.
In this embodiment, the manufacturing process of the vitamin D soft capsule is different from that of the first embodiment in that: the amounts of the components added were varied, and the amounts of dibutylhydroxytoluene and glycerol monostearate added in step a were 0.066 parts and 66 parts, and the amounts of dibutylhydroxytoluene and glycerol monostearate added in step b were 0.034 parts and 134 parts, respectively.
The content of calcium in each vitamin D soft capsule prepared in this example was 197 mg, and the content of vitamin D was 1.6 μ g.
Example seven,
The vitamin D soft capsule consists of the following substances in parts by mass:
400 parts of calcium carbonate; vitamin D30.002 part;
450 parts of soybean oil; 500 parts of gelatin;
700 parts of purified water; 200 parts of glycerol;
300 parts of glycerin monostearate; 0.02 part of titanium dioxide;
100 parts of corn oil; 0.1 part of butylated hydroxytoluene.
In this embodiment, the manufacturing process of the vitamin D soft capsule is different from that of the first embodiment in that: the amounts of the components added were varied, and the amount of dibutylhydroxytoluene added in step a was 0.066 parts and the amount of glyceryl monostearate was 100 parts, and the amount of dibutylhydroxytoluene added in step b was 0.034 parts and the amount of glyceryl monostearate was 200 parts.
The content of calcium in each vitamin D soft capsule prepared in this example was 152 mg, and the content of vitamin D was 1.9 μ g.
Example eight,
The vitamin D soft capsule consists of the following substances in parts by mass:
450 parts of calcium carbonate; vitamin D30.003 part of a mixture;
500 parts of soybean oil; 550 parts of gelatin;
500 parts of purified water; 150 parts of glycerol;
200 parts of glycerin monostearate; 0.015 part of titanium dioxide;
100 parts of corn oil; 0.15 part of butylated hydroxytoluene.
In this embodiment, the manufacturing process of the vitamin D soft capsule is different from that of the first embodiment in that: the amounts of the components added were varied, and the amount of dibutylhydroxytoluene added in step a was 0.1 part and the amount of glyceryl monostearate was 66 parts, and the amount of dibutylhydroxytoluene added in step b was 0.05 part and the amount of glyceryl monostearate was 134 parts.
The content of calcium in each vitamin D soft capsule prepared in this example was 161 mg, and the content of vitamin D was 2.7 μ g.
Examples nine,
The vitamin D soft capsule consists of the following substances in parts by mass:
565 parts of calcium carbonate; vitamin D30.003 part of a mixture;
250 parts of soybean oil; 600 parts of gelatin;
550 parts of purified water; 200 parts of glycerol;
100 parts of glycerin monostearate; 0.02 part of titanium dioxide;
150 parts of corn oil; 0.15 part of butylated hydroxytoluene.
In this embodiment, the manufacturing process of the vitamin D soft capsule is different from that of the first embodiment in that: the amounts of the components added were varied, and the amount of dibutylhydroxytoluene added in step a was 0.1 part and the amount of glyceryl monostearate was 33 parts, and the amount of dibutylhydroxytoluene added in step b was 0.05 part and the amount of glyceryl monostearate was 67 parts.
The content of calcium in each vitamin D soft capsule prepared in this example was 226 mg, and the content of vitamin D was 3.0 μ g.
The vitamin D soft capsule is further subjected to a freshness test, the freshness test comprises a test of the water content of the capsule shell of the soft capsule and a test of the calcium carbonate residue amount of the capsule shell, and the method for testing the water content comprises the following steps: selecting 100 soft capsules of the invention and 100 soft capsules of one commercially available soft capsule, uniformly spreading the soft capsules on the bottom of a ventilated and dried container, and randomly taking out 10 soft capsules of the two soft capsules in the container every 30 days to test the water content; in the testing process, the water contents of the two taken soft capsule shells are respectively tested by a rapid capsule moisture meter, and the results are recorded in table 1;
TABLE 1 moisture content test results for vitamin D soft capsules
Figure BDA0001971200240000111
The method for testing the calcium carbonate residue of the soft capsule shell comprises the following steps: selecting 100 soft capsules of the invention and 100 soft capsules of one commercially available soft capsule, placing the soft capsules in a sealed lightproof container, and randomly taking 10 soft capsules out of the container every 6 months for residue test; in the testing process, each soft capsule taken out is cut, the content is extruded out, the content of the calcium carbonate remained in the capsule shell is collected and tested, and the testing result is shown in table 2;
TABLE 2 test results of calcium carbonate residue in the capsule shell of vitamin D soft capsules
Figure BDA0001971200240000121
Compared with a control, the capsule shell of the vitamin D soft capsule prepared by the invention has better moisture retention, can keep fresh for two months even being exposed in flowing dry air, and is not easy to dehydrate and harden because of the dry air; on the other hand, the capsule content of the invention has better stability and less calcium carbonate precipitation, and is convenient for extrusion and eating and absorption by human body.
Compared with the prior art, the invention has the following advantages:
a. the components are simple, the additive is few, and anaphylactic reaction or other discomfort caused by excessive additive can be avoided;
b. the capsule content is more uniformly and stably mixed, the phenomena of oil layer separation, calcium carbonate precipitation and the like can not occur, calcium carbonate or vitamin D can not remain in the capsule shell even if the content is extruded for eating, and the intake of effective components can not be reduced;
c. the capsule shell of the soft capsule has a good water locking effect, and experiments prove that the soft capsule can keep elastic freshness for two months even if exposed to flowing and dry air, and is generally stored in a bottle with a cover during daily taking, so that the hard shell phenomenon can not occur even if the soft capsule is taken for a long time, and the taking taste is improved.
The above embodiments are not intended to limit the present invention, and the present invention is not limited to the above examples, and those skilled in the art may make variations, modifications, additions or substitutions within the technical scope of the present invention.

Claims (1)

1. A vitamin D soft capsule is characterized in that: the vitamin D soft capsule consists of the following substances in parts by mass:
400-625 parts of calcium carbonate; vitamin D30.001 to 0.005 part;
225-550 parts of soybean oil; 425-650 parts of gelatin;
450-700 parts of purified water; 110-325 parts of glycerol;
100-400 parts of glycerin monostearate; 0.01-0.02 part of titanium dioxide;
100-200 parts of corn oil; 0.05-0.2 part of dibutyl hydroxy toluene;
the preparation method of the vitamin D soft capsule comprises the following steps:
a. preparing capsule content; grinding the calcium carbonate solid into calcium carbonate powder which can pass through a 200-mesh sieve, and uniformly mixing the calcium carbonate powder with the soybean oil by a colloid mill to obtain a calcium agent; mixing vitamin D3Adding into corn oil, mechanically stirring, and continuously adding dibutyl hydroxy toluene while stirring, wherein the amount of added dibutyl hydroxy toluene is 2/3 of total amount of dibutyl hydroxy toluene, and the rest 1/3 of dibutyl hydroxy toluene is used; continue to stir 1EAfter 2 minutes, the mixture is introduced into a colloid mill and is uniformly ground to prepare the vitamin preparation; grinding and mixing the calcium agent, the vitamin agent and 1/3 glyceryl monostearate by a colloid mill to obtain uniform capsule contents;
b. manufacturing mucilage; heating purified water at room temperature, and dissolving glycerol in the purified water during heating to form glycerol aqueous solution; when the temperature of the glycerin water solution is raised to 55 ℃, gelatin is added and slowly stirred to accelerate the dissolution of the gelatin to prepare gelatin water; sequentially adding the titanium dioxide, the 1/3 dibutyl hydroxy toluene remained in the step a and 2/3 glyceryl monostearate into gelatin water, and uniformly grinding the materials by a colloid mill to obtain a mucilage;
c. making a soft capsule comprising capsule contents; b, putting the content of the capsule prepared in the step a into an oil hopper of a pill dropping machine, putting the mucilage prepared in the step b into a glue hopper, arranging a cooling cup below an outlet of a concentric tube of the pill dropping machine, and pouring a coolant into the cooling cup; setting a pill dropping machine to enable the content of a capsule in each pill to be 1000 mg, after the pill dropping machine is started, dropping the mucilage from an outlet of a concentric tube before the content of the capsule, dropping the mucilage onto the upper surface of a coolant and unfolding to form a rubber, dropping the content of the capsule onto the surface of the rubber which is just unfolded immediately, wherein the rubber sinks in the coolant continuously due to the acceleration of gravity, the rubber is completely sealed under the action of molecular force of the coolant, the content of the capsule is wrapped in the rubber, and the rubber is made into a spherical shape under the action of surface tension, so that the rubber is gradually solidified due to the gradual reduction of the temperature of the coolant along with the sinking of the rubber, and the soft capsule containing the content of the capsule is prepared;
d. processing the vitamin D soft capsule after preparation; taking out the soft capsule containing the capsule content prepared in the step c from the coolant, primarily drying the soft capsule in cold air at room temperature, washing the soft capsule after drying until no obvious coolant water stain residue exists, firstly washing the soft capsule with petroleum ether twice, then washing the soft capsule in ethanol with the concentration of 95%, and drying the soft capsule for 8-12 hours at the temperature of 30-35 ℃, thus completing the whole process of preparing the vitamin D soft capsule;
the coolant is liquid paraffin or vegetable oil; the temperature of the coolant is 10-15 ℃.
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