CN106723064A - A kind of vitamin D3Soft capsule and preparation method thereof - Google Patents
A kind of vitamin D3Soft capsule and preparation method thereof Download PDFInfo
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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Abstract
The invention belongs to technical field of health care food, and in particular to a kind of vitamin D3Soft capsule and preparation method thereof.The vitamin D that the present invention is provided3Soft capsule is made up of content and softgel shell, and the content is main by vitamin D3Powder and vegetable oil are constituted, and the softgel shell is mainly made up of acidylated gelatin, stabilizer, PEG400, colouring agent, sweetener and purified water.The vitamin D that the present invention is provided3Soft capsule is targeting enteron aisle disintegration, soluble in water, can directly by small intestine, colonic absorption, it is to avoid vitamin D3Destroyed by hydrochloric acid in gastric juice during by stomach, substantially increased its bioavilability；Meanwhile, the vitamin D3Soft capsule also has stability advantage high, in good taste, greatly promotes the vitamin D3The promotion and application of soft capsule.
Description
Technical field
The invention belongs to technical field of health care food, and in particular to a kind of vitamin D3Soft capsule and preparation method thereof.
Background technology
Vitamin D3It is a kind of liposoluble vitamin, is one of necessary nutrient of human body.It is main subcutaneous by human body
Cholesterol is formed through ultraviolet irradiation transformation, it is also possible to obtained from animal food.Research has shown that, vitamin D3With firm
The effect of bone, can effectively prevent the diseases such as children rachitis and senile osteoporosis and decayed tooth.Meanwhile, it heart,
Played an important role in the system such as blood vessel, nerve, immune, one of important element essential to human body.
With China's urbanization propulsion and living-pattern preservation, general population is reduced the outdoor activities time increasingly, so that
Have influence on the synthesis of body vitamin D.China's Healthy promotes a report of foundation to point out, China's big city crowd's vitamin D
Famine person is up to 21 parts.2013 editions are issued according to Chinese Soclety of Nutrition《DRIs》, often
Day vitamin D intake value is minimum 400IU/ days.Vitamin D3As one of most important member of vitamin D family, therefore, fit
When vitamin D3It is very necessary.
Vitamin D currently on the market3Replenishers are generally tablet, the preparation of most softgel shell not through scientific compatibility, its technique
Recipe-imposed softgel shell and content stability, bioavilability and mouthfeel, and have peculiar taste, and require supplementation with vitamin
D3Main population be pregnant women and less than 10 years old child, it is impossible to meet modern Man's Demands.
Patent document CN105476020A disclosed a kind of vitamin D on November 30th, 20153Soft capsule and its preparation
Method, the vitamin D3Soft capsule includes content and softgel shell, and the content is main by vitamin D3, vitamin D2, core
Peach oil, eucommia ulmoides seed oil, granada seed oil, amino acid, calcium citrate, antioxidant and stabilizer composition；The softgel shell is main by bright
Glue, glycerine, titanium dioxide and purified water composition, the vitamin D for preparing3Soft capsule has enhancing cerebral function, enhancing people
Body immunity function, promotes brain and nervous system development, removes interior free yl, the effects such as prevent various chronic diseases to occur.But
It is the vitamin D3Soft capsule contains preservative, although the content of the preservative is in the range of safe handling, but long-term consumption
The injury that can not be born can be caused to infant, the vitamin D is greatly limit3The application of soft capsule.
Patent document CN102125581A disclosed a kind of preparation method of dimension D calcium soft capsules, institute on January 14th, 2010
Dimension D calcium soft capsules are stated by Paris white, vitamin D3, soybean salad oil, the raw material composition such as soybean lecithin and beeswax, prepare
Dimension D calcium soft capsules can increase human calcium and vitamin D3Uptake.But, dimension D calcium soft capsules bioavilability compared with
It is low, less stable, it is impossible to meet the requirement of people.
Therefore, the dimension that a kind of bioavilability is high, stability strong and can carry out Colon-specific release is researched and developed out
Raw element D3Soft capsule is still the problem of current urgent need to resolve.
The content of the invention
In order to solve vitamin D in the prior art3There is the defect that bioavilability is low, stability is poor, this hair in soft capsule
Bright purpose is to provide a kind of vitamin D3Soft capsule and preparation method thereof, to solve drawbacks described above.
The invention provides a kind of vitamin D3Soft capsule, is made up of content and softgel shell, and the content includes as follows
Preparing raw material and its percentage by weight：Vitamin D3Powder 30-60 parts and vegetable oil 40-70 parts；The vitamin D3The system of powder
Preparation Method is：
A. by 40-70 parts of vitamin D3, 50-75 parts of vegetable oil, 0.01-0.5 parts of antioxidant, 0.5-2 parts of emulsifying agent, plus
Hot to 45-75 DEG C stirs and evenly mixs, and obtains oil phase；
B. 5-10 parts of protein, 20-40 parts of modified starch, 1-5 parts of sodium carboxymethylcellulose, 1-5 parts of sucrose ester are dissolved in
In 40-80 parts of purified water, it is heated to 45-70 DEG C and stirs and evenly mixs, obtains water phase；
C. water that the oil phase for step A being obtained is obtained with step B mutually by volume 1:1 mixing, in the condition of 20-60MPa
Lower homogeneous 2-3 times, each 20-40min obtains microemulsion, and the average grain diameter of the microemulsion is 100-300nm；
D. the microemulsion for step C being obtained adds spray drying system, and intake air temperature is 160-190 DEG C, air outlet temperature
It is 80-100 DEG C to spend, and obtains vitamin D3Powder；
The softgel shell includes following preparing raw material and its parts by weight：Acidylated gelatin 20-40 parts, stabilizer 25-50 parts, it is poly-
Ethylene glycol 4000.1-0.5 parts, colouring agent 0-0.5 parts, opacifier 0.1-0.5 parts, sweetener 0.01-0.2 parts and purified water 20-
40 parts.
Further, the content includes following preparing raw material and its parts by weight：Vitamin D345 parts of powder, plant
55 parts of oil；The vitamin D3The preparation method of powder is：
A. by 48 parts of vitamin Ds3, 52 parts of vegetable oil, 0.2 part of antioxidant, 0.8 part of emulsifying agent, be heated to 65 DEG C of stirrings
Mix, obtain oil phase；
B. 8 parts of protein, 32 parts of modified starches, 2 parts of sodium carboxymethylcelluloses, 3 parts of sucrose esters are dissolved in 60 parts of purified waters
In, it is heated to 55 DEG C and stirs and evenly mixs, obtain water phase；
C. water that the oil phase that step A is obtained is obtained with step B mutually by volume 1:1 mixing, homogeneous 2 under the conditions of 40MPa
It is secondary, each 30min, microemulsion, the average grain diameter of the microemulsion is 100-300nm；
D. the microemulsion for step C being obtained adds spray drying system, and intake air temperature is 175 DEG C, and air outlet temperature is
90 DEG C, obtain vitamin D3Powder.
Further, the softgel shell includes following preparing raw material and its percentage by weight：
28 parts of acidylated gelatin, 35 parts of stabilizer, Macrogol 4000 .3 parts, 0.2 part of colouring agent, 0.2 part of opacifier, sweet taste
32 parts of 0.06 part of agent and purified water.
Further, the vegetable oil be in walnut oil, olive oil, the young oil of flax and coconut oil one or two with
On；The antioxidant be tert-butylhydroquinone, ethoxyquinoline and tocopherol in one or more；The emulsification
Agent is lecithin or glycerin monostearate.
Further, the protein is Bos taurus domesticus Gmelin or soybean protein；The modified starch is maltodextrin or β-ring paste
Essence.
Further, the preparation method of the acidylated gelatin is：The Bos taurus domesticus Gmelin solution of 70 part 3% of configuration, adds 2mol/L
NaOH solution regulation pH value is 9.7, the water-bath 30min under 65 DEG C of constant temperatures；Then at 45 DEG C, the constant temperature magnetic of 500rpm/min
5 parts of ethylenediamine tetra-acetic acid dianhydrides are slowly added under power stirring, regulation pH value is 9.7, after acylation reaction 4h, bag filter dialysis 48h
Until the pH value of water is 7, it is 15% to be placed in polyglycol solution and be concentrated into protein concentration, is subsequently added into the penta 2 of 1 part 25%
Aldehyde solution, at 45 DEG C, the lower crosslinking curing 60min of constant temperature stirring of 500rpm/min is aged 24h at room temperature, freezes, and dries, i.e.,
.
Further, the stabilizer is by sorbierite and polyacrylic resin 1-3 by weight:2-4 is constituted.
Further, the stabilizer is by sorbierite and polyacrylic resin by weight 2:3 compositions.
Further, the colouring agent is famille rose, amaranth, sunset yellow, erythrosine, lemon yellow, light green, indigo and bright
One or more in basket；The opacifier is titanium dioxide or iron oxide；The sweetener is sucrose or Aspartame.
In addition, present invention also offers a kind of vitamin D3The preparation method of soft capsule, comprises the following steps：
S1 is by 40-70 parts of vitamin D3, 50-75 parts of vegetable oil, 0.01-0.5 parts of antioxidant, 0.5-2 parts of emulsifying agent, plus
Hot to 45-75 DEG C stirs and evenly mixs, and obtains oil phase；
Be dissolved in for 5-10 parts of protein, 20-40 parts of modified starch, 1-5 parts of sodium carboxymethylcellulose, 1-5 parts of sucrose ester by S2
In 40-80 parts of purified water, it is heated to 45-70 DEG C and stirs and evenly mixs, obtains water phase；
Water that the oil phase that S3 obtains step S1 is obtained with step S2 mutually by volume 1:1 mixing, in the bar of 20-60MPa
Homogeneous 2-3 times under part, each 20-40min obtains microemulsion, and the average grain diameter of the microemulsion is 100-300nm；
The microemulsion that S4 obtains step S3 adds spray drying system, and intake air temperature is 160-190 DEG C, air outlet temperature
It is 80-100 DEG C to spend, and obtains vitamin D3Powder；
The vitamin D that S5 obtains step S43Powder is well mixed with vegetable oil, obtains content；
Acidylated gelatin, stabilizer, PEG400, colouring agent, opacifier, sweetener and purified water are added and match somebody with somebody glue by S6
Stirred and evenly mixed in tank, removal of impurities, vacuum defoamation, preserved under the conditions of 60 DEG C, obtain capsule shell fluid；
The content that S7 obtains step S5 obtains softgel shell glue and is pressed into soft capsule through pellet press with step S6, then through washing
Ball, drying, packaging, obtain final product.
No. CAS of the walnut oil that the present invention is provided is 8024-09-7, and No. CAS of glycerin monostearate is 123-94-4,
No. CAS of lecithin is 8002-43-5, No. CAS of maltodextrin：9004-53-9.
The vitamin D that the present invention is provided3Soft capsule uses microcapsules technology by vitamin D3Parcel, can effectively reduce
External environment is to vitamin D3Influence, while vitamin D can also be improved3Water solubility and bioactivity, it is wrapped after dimension life
Plain D3It is easier to be absorbed by the body in enteron aisle, utilizes, greatly improves vitamin D3The bioavilability of soft capsule.
The stabilizer and acidylated gelatin that are made up of by certain weight ratio sorbierite and polyacrylic resin that the present invention is provided
Interaction can effectively strengthen vitamin D3The integrality and stability of soft capsule shell.Found through experiment, by the present invention
The vitamin D for preparing3Soft capsule is put into the glass tube stood upright on plank (thickness 2cm) that (internal diameter is 24mm, a length of
200mm) in, by cylindrical counterweight (material is polytetrafluoroethylene (PTFE), a diameter of 22mm, weight 20g ± 0.1g) from the glass mouth of pipe from
By falling, the soft capsule number of rupture is 0, and the dimension life that the present invention is provided after irradiation 10 days under the 4000 lux fluorescent lamps
Plain D3The vitamin D of soft capsule3Survival rate is more than 90%, illustrates what sorbierite and polyacrylic resin were constituted by certain weight ratio
Stabilizer interacts with acidylated gelatin can effectively strengthen vitamin D3The integrality and stability of soft capsule shell.
Further, the present invention is using the stabilizer and acyl being made up of by certain weight ratio sorbierite and polyacrylic resin
Change the softgel shell that gelatin is prepared, be not required to add antioxidant in addition, you can with good oxidation resistant effect, extend vitamin
D3The shelf-life of soft capsule, can effectively material-saving, reduces cost.
In addition, the vitamin D that the present invention is provided3The formula of soft capsule rationally, science, each composition is mutually coordinated to make preparation
Soft capsule can be disintegrated in intestinal-specific enteron aisle, directly by small intestine, colonic absorption, it is to avoid vitamin D3Hydrochloric acid in gastric juice is subject to through stomach
Destruction, it is ensured that vitamin D3It is both effectiveness；Meanwhile, it also has the advantages that, and plasticity is strong, stability is high and in good taste, favorably
In the vitamin D3The promotion and application of soft capsule.
Compared with prior art, the vitamin D that the present invention is provided3Soft capsule has the advantage that：
(1) vitamin D that the present invention is provided3Soft capsule can effectively solve vitamin D3Soft capsule is during storage
The problem of rupture is susceptible to, vitamin D can be effectively improved3The exterior quality of soft capsule；
(2) vitamin D that the present invention is provided3Soft capsule also has the advantages that plasticity is strong, stability is high and in good taste, has
Beneficial to the vitamin D3The promotion and application of soft capsule.
Specific embodiment：
Below by way of the description of specific embodiment, the invention will be further described, but this is not to limit of the invention
System, those skilled in the art's basic thought of the invention, various modifications may be made or improves, but without departing from this
The basic thought of invention, within the scope of the present invention.Composition of the invention is conventional commercially available prod, for example：Olive oil
The happy supply chain Co., Ltd of sea cowry before Shenzhen is purchased from, article No. is 85255；Flax son's oil is purchased from Zhangjiakou City deer source nutrition grease
Co., Ltd；Coconut oil is purchased from Shanghai Pan Chen trade Co., Ltds, model supercoco；Polyacrylic resin is purchased from Wuhan
Jin Nuo Chemical Co., Ltd.s；Bos taurus domesticus Gmelin is purchased from Luo Sailuo (Guangdong) gelatin Co., Ltd, and soybean protein is purchased from the safe and sound biology in Shenzhen
Science and Technology Ltd..
Embodiment 1, a kind of preparation of acidylated gelatin
The Bos taurus domesticus Gmelin solution of 70 part 3% of configuration, it is 9.7 to add 2mol/L NaOH solutions regulation pH value, in 65 DEG C of constant temperature bars
Water-bath 30min under part；Then at 45 DEG C, 5 parts of ethylenediamine tetra-acetic acids two are slowly added under the temperature constant magnetic stirring of 500rpm/min
Acid anhydride, regulation pH value is 9.7, and after acylation reaction 4h, bag filter dialysis 48h is 7 up to the pH value of water, is placed in polyglycol solution
It is 15% to be concentrated into protein concentration, is subsequently added into 1 part 25% of glutaraldehyde solution, and at 45 DEG C, the constant temperature of 500rpm/min is stirred
Lower crosslinking curing 60min, is aged 24h at room temperature, freezing, dries, and obtains final product.
Embodiment 2, a kind of vitamin D3Soft capsule
The vitamin D3Soft capsule is made up of content and softgel shell：
The content is made up of following preparing raw material and its parts by weight：Vitamin D330 parts of powder and olive oil 40
Part；
The vitamin D3The preparation method of powder is：
A. by 40 parts of vitamin Ds3, 50 parts of olive oil, 0.03 part of tert-butylhydroquinone, 0.5 part of monoglyceride, be heated to 45
DEG C stir and evenly mix, obtain oil phase；
B. 5 parts of Bos taurus domesticus Gmelins, 20 parts of maltodextrins, 2 parts of sodium carboxymethylcelluloses, 3 parts of sucrose esters are dissolved in 40 parts of purified waters
In, it is heated to 45 DEG C and stirs and evenly mixs, obtain water phase；
C. water that the oil phase that step A is obtained is obtained with step B mutually by volume 1:1 mixing, homogeneous 2 under the conditions of 20MPa
It is secondary, each 20min, microemulsion, the average grain diameter of the microemulsion is 100nm；
D. the microemulsion for step C being obtained adds spray drying system, and intake air temperature is 160 DEG C, and air outlet temperature is
80 DEG C, obtain vitamin D3Powder；
The softgel shell is made up of following preparing raw material and its parts by weight：
20 parts of acidylated gelatin, 25 parts of stabilizer, Macrogol 4000 .2 parts, carmine 0.05 part, 0.05 part of sunset yellow, oxygen
Change 20 parts of 0.1 part of titanium, 0.04 part of sucrose and purified water；The acidylated gelatin that the acidylated gelatin is prepared using embodiment 1；It is described steady
Agent is determined by sorbierite and polyacrylic resin by weight 1:4 compositions.
Preparation method：
S1 is by 40 parts of vitamin Ds3, 50 parts of olive oil, 0.03 part of tert-butylhydroquinone, 0.5 part of monoglyceride, be heated to 45
DEG C stir and evenly mix, obtain oil phase；
5 parts of Bos taurus domesticus Gmelins, 20 parts of maltodextrins, 2 parts of sodium carboxymethylcelluloses, 3 parts of sucrose esters are dissolved in 40 parts of purified waters by S2
In, it is heated to 45 DEG C and stirs and evenly mixs, obtain water phase；
Water that the oil phase that S3 steps S1 is obtained is obtained with step S2 mutually by volume 1:1 mixing, the homogeneous under the conditions of 20MPa
2 times, each 20min, microemulsion, the average grain diameter of the microemulsion is 100nm；
The microemulsion that S4 obtains step S3 adds spray drying system, and intake air temperature is 160 DEG C, and air outlet temperature is
80 DEG C, obtain vitamin D3Powder；
The vitamin D that S5 obtains step S43Powder is uniform with mixed with olive oil, obtains content；
S6 adds acidylated gelatin, stabilizer, PEG400, famille rose, sunset yellow, titanium oxide, sucrose, purified water
With being stirred and evenly mixed in glue tank, the stabilizer is sorbierite and polyacrylic resin by weight 1:4 compositions, removal of impurities, vacuum take off
Bubble, preserves under the conditions of 60 DEG C, obtains capsule shell fluid；
The content that S7 obtains step S5 obtains softgel shell glue and is pressed into soft capsule through pellet press with step S6, then through washing
Ball, drying, packaging, obtain final product.
Embodiment 3, a kind of vitamin D3Soft capsule
The vitamin D3Soft capsule is made up of content and softgel shell：
The content is made up of following preparing raw material and its parts by weight：Vitamin D345 parts of powder and walnut oil 55
Part；
The vitamin D3The preparation method of powder is：
A. by 48 vitamin Ds3, 52 walnut oils, 0.2 part of ethoxyquinoline, 0.8 part of glycerol monostearate, be heated to 65 DEG C
Stir and evenly mix, obtain oil phase；
B. 8 portions of soybean proteins, 32 parts of beta-schardinger dextrins, 2 parts of sodium carboxymethylcelluloses, 3 parts of sucrose esters are dissolved in 60 parts of purifying
In water, it is heated to 55 DEG C and stirs and evenly mixs, obtains water phase；
C. water that the oil phase that step A is obtained is obtained with step B mutually by volume 1:1 mixing, homogeneous 2 under the conditions of 40MPa
It is secondary, each 30min, microemulsion, the average grain diameter of the microemulsion is 200nm；
D. the microemulsion for step C being obtained adds spray drying system, and intake air temperature is 175 DEG C, and air outlet temperature is
90 DEG C, obtain vitamin D3Powder；
The softgel shell is made up of following preparing raw material and its parts by weight：
28 parts of acidylated gelatin, 35 parts of stabilizer, Macrogol 4000 .3 parts, 0.1 part of lemon yellow, light green 0.1 part, iron oxide
32 parts of 0.2 part, 0.06 part of Aspartame and purified water；The acidylated gelatin that the acidylated gelatin is prepared using embodiment 1；It is described steady
Agent is determined by sorbierite and polyacrylic resin by weight 2:3 compositions.
Preparation method：
S1 is by 48 vitamin Ds3, 52 walnut oils, 0.2 part of ethoxyquinoline, 0.8 part of glycerol monostearate, be heated to 65 DEG C
Stir and evenly mix, obtain oil phase；
8 portions of soybean proteins, 32 parts of beta-schardinger dextrins, 2 parts of sodium carboxymethylcelluloses, 3 parts of sucrose esters are dissolved in 60 parts of purifying by S2
In water, it is heated to 55 DEG C and stirs and evenly mixs, obtains water phase；
Water that the oil phase that S3 steps S1 is obtained is obtained with step S2 mutually by volume 1:1 mixing, the homogeneous under the conditions of 40MPa
2 times, each 30min, microemulsion, the average grain diameter of the microemulsion is 200nm；
The microemulsion that S4 obtains step S3 adds spray drying system, and intake air temperature is 175 DEG C, and air outlet temperature is
90 DEG C, obtain vitamin D3Powder；
The vitamin D that S5 obtains step S43Powder is well mixed with walnut oil, obtains content；
S6 adds acidylated gelatin, stabilizer, PEG400, lemon yellow, light green, iron oxide, Aspartame and purified water
Enter with being stirred and evenly mixed in glue tank, the stabilizer is by sorbierite and polyacrylic resin by weight 2:3 compositions, removal of impurities, vacuum
Deaeration, preserves under the conditions of 60 DEG C, obtains capsule shell fluid；
The content that S7 obtains step S5 obtains softgel shell glue and is pressed into soft capsule through pellet press with step S6, then through washing
Ball, drying, packaging, obtain final product.
Embodiment 4, a kind of vitamin D3Soft capsule
The vitamin D3Soft capsule is made up of content and softgel shell：
The content is made up of following preparing raw material and its parts by weight：Vitamin D360 parts of powder and coconut oil 70
Part；
The vitamin D3The preparation method of powder is：
A. by 70 parts of vitamin Ds3, 5 parts of coconut oil, 0.4 part of tocopherol, 2 parts of glycerol monostearates, be heated to 75 DEG C of stirrings
Mix, obtain oil phase；
B. 10 portions of soybean proteins, 40 portions of maltodextrins, 4 parts of sodium carboxymethylcelluloses, 4 parts of sucrose esters are dissolved in 80 parts of purifying
In water, it is heated to 70 DEG C and stirs and evenly mixs, obtains water phase；
C. water that the oil phase that step A is obtained is obtained with step B mutually by volume 1:1 mixing, homogeneous 3 under the conditions of 60MPa
It is secondary, each 20min, microemulsion, the average grain diameter of the microemulsion is 300nm；
D. the microemulsion for step C being obtained adds spray drying system, and intake air temperature is 190 DEG C, and air outlet temperature is
100 DEG C, obtain vitamin D3Powder；
The softgel shell is made up of following preparing raw material and its parts by weight：
40 parts of acidylated gelatin, 50 parts of stabilizer, Macrogol 4000 .4 parts, light green 0.1 part, indigo 0.2 part, iron oxide
40 parts of 0.4 part, 0.08 part of Aspartame and purified water；The acidylated gelatin that the acidylated gelatin is prepared using embodiment 1；It is described steady
Agent is determined by sorbierite and polyacrylic resin by weight 3:2 compositions.
Preparation method：
S1 is by 70 parts of vitamin Ds3, 5 parts of coconut oil, 0.4 part of tocopherol, 2 parts of glycerol monostearates, be heated to 75 DEG C of stirrings
Mix, obtain oil phase；
10 portions of soybean proteins, 40 portions of maltodextrins, 4 parts of sodium carboxymethylcelluloses, 4 parts of sucrose esters are dissolved in 80 parts of purifying by S2
In water, it is heated to 70 DEG C and stirs and evenly mixs, obtains water phase；
Water that the oil phase that S3 steps A is obtained is obtained with step B mutually by volume 1:1 mixing, homogeneous 3 under the conditions of 60MPa
It is secondary, each 20min, microemulsion, the average grain diameter of the microemulsion is 300nm；
The microemulsion that S4 obtains step S3 adds spray drying system, and intake air temperature is 190 DEG C, and air outlet temperature is
100 DEG C, obtain vitamin D3Powder；
The vitamin D that S5 obtains step S43Powder is well mixed with coconut oil, obtains content；
Acidylated gelatin, stabilizer, PEG400, light green, indigo, iron oxide, Aspartame purified water are added and matched somebody with somebody by S6
Stirred and evenly mixed in glue tank, the stabilizer is by sorbierite and polyacrylic resin by weight 3:2 compositions, removal of impurities, vacuum defoamation,
Preserved under the conditions of 60 DEG C, obtain capsule shell fluid；
The content that S7 obtains step S5 obtains softgel shell glue and is pressed into soft capsule through pellet press with step S6, then through washing
Ball, drying, packaging, obtain final product.
Comparative example 1, a kind of vitamin D3Soft capsule
The vitamin D3Soft capsule is made up of content and softgel shell：
The content is made up of following preparing raw material and its parts by weight：Vitamin D345 parts and 55 parts of walnut oil；
The softgel shell is made up of following preparing raw material and its parts by weight：
28 parts of acidylated gelatin, 35 parts of stabilizer, Macrogol 4000 .3 parts, 0.1 part of lemon yellow, light green 0.1 part, iron oxide
32 parts of 0.2 part, 0.06 part of Aspartame and purified water；The acidylated gelatin that the acidylated gelatin is prepared using embodiment 1；It is described steady
Agent is determined by sorbierite and polyacrylic resin by weight 2:3 compositions.
Preparation method：
S1 is by vitamin D3Powder is well mixed with vegetable oil, obtains content；
S2 adds acidylated gelatin, stabilizer, PEG400, lemon yellow, light green, iron oxide, Aspartame and purified water
Enter with being stirred and evenly mixed in glue tank, the stabilizer is by sorbierite and polyacrylic resin by weight 2:3 compositions, removal of impurities, vacuum
Deaeration, preserves under the conditions of 60 DEG C, obtains capsule shell fluid；
The content that S3 obtains step S1 obtains softgel shell glue and is pressed into soft capsule through pellet press with step S2, then through washing
Ball, drying, packaging, obtain final product.
The difference of embodiment 3 is, the vitamin D3Do not carry out encapsulation.
Comparative example 2, a kind of vitamin D3Soft capsule
The vitamin D3Soft capsule is made up of content and softgel shell：
The content constitutes similar to Example 3 by following preparing raw material and its parts by weight；
The softgel shell is made up of following preparing raw material and its parts by weight：
28 parts of acidylated gelatin, 35 parts of sorbierite, Macrogol 4000 .3 parts, 0.1 part of lemon yellow, light green 0.1 part, iron oxide
32 parts of 0.2 part, 0.06 part of Aspartame and purified water；The acidylated gelatin that the acidylated gelatin is prepared using embodiment 1.
Preparation method is similar to Example 3.
The difference of embodiment 3 is that the stabilizer is sorbierite.
Comparative example 3, a kind of vitamin D3Soft capsule
The vitamin D3Soft capsule is made up of content and softgel shell：
The content constitutes similar to Example 3 by following preparing raw material and its parts by weight；
The softgel shell is made up of following preparing raw material and its parts by weight：
28 parts of acidylated gelatin, 35 parts of stabilizer, Macrogol 4000 .3 parts, 0.1 part of lemon yellow, light green 0.1 part, iron oxide
32 parts of 0.2 part, 0.06 part of Aspartame and purified water；The acidylated gelatin that the acidylated gelatin is prepared using embodiment 1；It is described steady
Agent is determined by sorbierite and polyacrylic resin by weight 1:1 composition.
Preparation method is similar to Example 3.
The difference of embodiment 3 is that the stabilizer is by sorbierite and polyacrylic resin by weight 1:1 composition.
Comparative example 4, a kind of vitamin D3Soft capsule
The vitamin D3Soft capsule is made up of content and softgel shell：
The content constitutes similar to Example 3 by following preparing raw material and its parts by weight；
The softgel shell is made up of following preparing raw material and its parts by weight：
28 parts of edible gelatin, 35 parts of stabilizer, Macrogol 4000 .3 parts, 0.1 part of lemon yellow, light green 0.1 part, iron oxide
32 parts of 0.2 part, 0.06 part of Aspartame and purified water；The acidylated gelatin that the acidylated gelatin is prepared using embodiment 1；It is described steady
Agent is determined by sorbierite and polyacrylic resin by weight 2:3 compositions.
Preparation method is similar to Example 3.
The difference of embodiment 3 is that acyl group gelatin is replaced with into edible gelatin.
Test example one, vitamin D3The stability test of soft capsule
1st, test material：Embodiment 2, embodiment 3, embodiment 4, comparative example 1, comparative example 2, comparative example 3 and comparative example 4 are made
Standby vitamin D3Soft capsule.
2nd, test method：
Determine dimension prepared by embodiment 2, embodiment 3, embodiment 4, comparative example 1, comparative example 2, comparative example 3 and comparative example 4
Raw element D3(VD3) soft capsule rupture number, simulated gastric fluid in be disintegrated situation, disintegration time limited (min), intense light irradiation in simulated intestinal fluid
Penetrate 4 days VD3Survival rate (%), 7 days VD of strong illumination3Survival rate (%), 10 days VD of strong illumination3Survival rate (%).
2.1st, the test of plasticity：With reference to the detection method of the easy brittleness of Chinese Pharmacopoeia gelatin hollow capsule,
Take vitamin D3Soft capsule 50, is put in surface plate, and immigration is filled in the drier of magnesium nitrate saturated solution, puts 25
DEG C of ± 1 DEG C constant temperature 24 hours, takes out, and is put into the glass tube stood upright on plank (thickness 2cm) that (internal diameter is by grain respectively immediately
24mm, a length of 200mm) in, by cylindrical counterweight (material is polytetrafluoroethylene (PTFE), a diameter of 22mm, weight 20g ± 0.1g) from glass
Freely fallen at the mouth of pipe, depending on vitamin D3Whether soft capsule ruptures, record rupture number.
2.2nd, the test of disintegration time limited：
With reference to two annex X A of Chinese Pharmacopoeia 2010 edition, by 4.1 lower method inspections, plus first in simulated gastric fluid after baffle plate
Middle to check 2 hours, the softgel shell of every must not have crack or disintegration；Take out again to inspection in simulated intestinal fluid after washing, should be in 1h
All disintegrations.Can not be completely disintegrated if any 1, separately take 6 retrials, regulation all should be met.
Simulated gastric fluid：The watery hydrochloric acid that concentration is 1mol/ml is taken, is diluted with water, pH is adjusted to 1.5, added in every 100ml liquid
Enter 1g pepsins, mix.
Simulated intestinal fluid：Take KH2PO46.8g is added water 500ml dissolvings, and pH to 6.8 is adjusted back with the NaOH of 0.1M.Per 100ml liquid
Middle addition 1g trypsase, mixes.
2.3rd, strong illumination is determined
Take vitamin D3Soft capsule 50 irradiates 10 days under 4000 lux fluorescent lamps, and the 4th, 7,10 days are separately sampled,
Use vitamin D before and after high performance liquid chromatograph determination test3Survival rate.
3rd, result of the test
Result of the test is as shown in table 1.
The vitamin D of table 13Soft capsule steady testing result
Note：Soft capsule disintegration time limited≤1h is possible, so simultaneously non-temporal is more short better.In test result,
Disintegration time is short to represent that structure is more loose, and antioxygenic property is poorer under intense light irradiation.
As shown in Table 1, the vitamin D that the present invention is provided3The softgel shell of soft capsule is not easily broken, and is not collapsed in simulated gastric fluid
Solution, it is to avoid vitamin D3Destroyed by hydrochloric acid in gastric juice by stomach, while can be disintegrated in simulated intestinal fluid, vitamin D3Directly
By small intestine, colonic absorption, bioavilability is improved；And the vitamin D that the present invention is provided3Soft capsule is in 4000 lux daylight
Vitamin D after being irradiated 10 days under lamp3Survival rate be more than 90%, with stability higher.And what comparative example 1-4 was prepared
Vitamin D3Rupture number and the vitamin D through strong illumination of soft capsule3Survival rate than embodiment of the present invention 1-3 prepare
Vitamin D3The effect of soft capsule is poor, illustrates the vitamin D of present invention offer3Flexible glue capsule formula is reasonable, mutually coordinated of each composition
Enhancing vitamin D3The effect of Stability of Soft Capsules.
Claims (10)
1. a kind of vitamin D3Soft capsule, is made up of content and softgel shell, it is characterised in that the content includes following preparation
Raw material and its parts by weight：
Vitamin D3Powder 30-60 parts and vegetable oil 40-70 parts；The vitamin D3The preparation method of powder is：
A. by 40-70 parts of vitamin D3, 50-75 parts of vegetable oil, 0.01-0.5 parts of antioxidant, 0.5-2 parts of emulsifying agent, be heated to
45-75 DEG C stirs and evenly mixs, and obtains oil phase；
B. 5-10 parts of protein, 20-40 parts of modified starch, 1-5 parts of sodium carboxymethylcellulose, 1-5 parts of sucrose ester are dissolved in 40-80
In part purified water, it is heated to 45-70 DEG C and stirs and evenly mixs, obtains water phase；
C. water that the oil phase for step A being obtained is obtained with step B mutually by volume 1:1 mixing, under conditions of 20-60MPa
Matter 2-3 times, each 20-40min obtains microemulsion, and the average grain diameter of the microemulsion is 100-300nm；
D. the microemulsion for step C being obtained adds spray drying system, and intake air temperature is 160-190 DEG C, and air outlet temperature is
80-100 DEG C, obtain vitamin D3Powder；
The softgel shell includes following preparing raw material and its parts by weight：
Acidylated gelatin 20-40 parts, stabilizer 25-50 parts, Macrogol 4000 .1-0.5 parts, colouring agent 0-0.5 parts, opacifier
0.1-0.5 parts, sweetener 0.01-0.2 parts and purified water 20-40 parts.
2. vitamin D as claimed in claim 13Soft capsule, it is characterised in that the content include following preparing raw material and
Its parts by weight：
Vitamin D345 parts of powder, 55 parts of vegetable oil；The vitamin D3The preparation method of powder is：
A. by 48 parts of vitamin Ds3, 52 parts of vegetable oil, 0.2 part of antioxidant, 0.8 part of emulsifying agent, be heated to 65 DEG C and stir and evenly mix,
Obtain oil phase；
B. 8 parts of protein, 32 parts of modified starches, 2 parts of sodium carboxymethylcelluloses, 3 parts of sucrose esters are dissolved in 60 parts of purified waters, plus
Hot to 55 DEG C stir and evenly mix, and obtain water phase；
C. water that the oil phase that step A is obtained is obtained with step B mutually by volume 1:1 mixing, homogeneous 2 times under the conditions of 40MPa, often
Secondary 30min, microemulsion, the average grain diameter of the microemulsion is 100-300nm；
D. the microemulsion for step C being obtained adds spray drying system, and intake air temperature is 175 DEG C, and air outlet temperature is 90 DEG C,
Obtain vitamin D3Powder.
3. vitamin D as claimed in claim 13Soft capsule, it is characterised in that the softgel shell include following preparing raw material and its
Parts by weight：
28 parts of acidylated gelatin, 35 parts of stabilizer, Macrogol 4000 .3 parts, 0.2 part of colouring agent, 0.2 part of opacifier, sweetener
0.06 part and 32 parts of purified water.
4. vitamin D as claimed in claim 1 or 23Soft capsule, it is characterised in that the vegetable oil be walnut oil, olive oil,
One or more in the young oil of flax and coconut oil；The antioxidant be tert-butylhydroquinone, ethoxyquinoline and
One or more in tocopherol；The emulsifying agent is lecithin or glycerin monostearate.
5. vitamin D as claimed in claim 1 or 23Soft capsule, it is characterised in that the protein is Bos taurus domesticus Gmelin or soybean egg
In vain；The modified starch is maltodextrin or beta-schardinger dextrin.
6. the vitamin D as described in claim 1 or 33Soft capsule, it is characterised in that the preparation method of the acidylated gelatin is：
The Bos taurus domesticus Gmelin solution of 70 part 3% of configuration, it is 9.7, the water-bath under 65 DEG C of constant temperatures to add 2mol/L NaOH solutions regulation pH value
30min；Then at 45 DEG C, 5 parts of ethylenediamine tetra-acetic acid dianhydrides are slowly added under the temperature constant magnetic stirring of 500rpm/min, adjust pH
It is 9.7 to be worth, and after acylation reaction 4h, bag filter dialysis 48h is 7 up to the pH value of water, is placed in and egg is concentrated into polyglycol solution
White concentration is 15%, is subsequently added into 1 part 25% of glutaraldehyde solution, and at 45 DEG C, the lower crosslinking of constant temperature stirring of 500rpm/min is solid
Change 60min, 24h is aged at room temperature, freeze, dry, obtain final product.
7. the vitamin D as described in claim 1 or 33Soft capsule, it is characterised in that the stabilizer is by sorbierite and polypropylene
Acid resin is by weight 1-3:2-4 is constituted.
8. vitamin D as claimed in claim 73Soft capsule, it is characterised in that the stabilizer is by sorbierite and polyacrylic acid
Resin is by weight 2:3 compositions.
9. the vitamin D as described in claim 1 or 33Soft capsule, it is characterised in that the colouring agent be famille rose, amaranth,
One or more in sunset yellow, erythrosine, lemon yellow, light green, indigo and light blue；The opacifier be titanium dioxide or
Iron oxide；The sweetener is sucrose or Aspartame.
10. a kind of vitamin D as described in claim 1-9 is any3The preparation method of soft capsule, it is characterised in that including following
Step：
S1 is by 40-70 parts of vitamin D3, 50-75 parts of vegetable oil, 0.01-0.5 parts of antioxidant, 0.5-2 parts of emulsifying agent, be heated to
45-75 DEG C stirs and evenly mixs, and obtains oil phase；
5-10 parts of protein, 20-40 parts of modified starch, 1-5 parts of sodium carboxymethylcellulose, 1-5 parts of sucrose ester are dissolved in 40-80 by S2
In part purified water, it is heated to 45-70 DEG C and stirs and evenly mixs, obtains water phase；
Water that the oil phase that S3 obtains step S1 is obtained with step S2 mutually by volume 1:1 mixing, under conditions of 20-60MPa
Homogeneous 2-3 times, each 20-40min obtains microemulsion, and the average grain diameter of the microemulsion is 100-300nm；
The microemulsion that S4 obtains step S3 adds spray drying system, and intake air temperature is 160-190 DEG C, and air outlet temperature is
80-100 DEG C, obtain vitamin D3Powder；
The vitamin D that S5 obtains step S43Powder is well mixed with vegetable oil, obtains content；
S6 adds with glue tank acidylated gelatin, stabilizer, PEG400, colouring agent, opacifier, sweetener and purified water
Stir and evenly mix, removal of impurities, vacuum defoamation, preserved under the conditions of 60 DEG C, obtain capsule shell fluid；
Content that S7 obtains step S5 and step S6 obtain softgel shell glue and are pressed into soft capsule through pellet press, then through wash ball,
Dry, pack, obtain final product.
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