CN110169955A - A kind of production method of the soft capsule shell based on modified starch - Google Patents
A kind of production method of the soft capsule shell based on modified starch Download PDFInfo
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- CN110169955A CN110169955A CN201910605404.6A CN201910605404A CN110169955A CN 110169955 A CN110169955 A CN 110169955A CN 201910605404 A CN201910605404 A CN 201910605404A CN 110169955 A CN110169955 A CN 110169955A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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Abstract
The embodiment of the present application discloses a kind of production method of soft capsule shell based on modified starch, including modified starch, carragheen, plasticizer, water, thickener, the weight percent of each component are as follows: modified starch 25~75%；Carragheen 10~30%；Plasticizer 10~25%；Water 40~50%；Pigment added by the color of thickener 2~12% and soft capsule capsule and pill as needed.The present invention is by being substituted for modified starch and carragheen for the main component gelatin of conventional capsules capsule material, overcome many disadvantages of gelatin, modified starch has film performance, gas barrier, caking property etc., and security performance is high and has preferable elasticity, and rate of dissolution is better than gelatin；The soft capsule prepared by modified starch and carragheen, property is relatively stable, crosslinking phenomena is not susceptible to, and do not have oxidation cross-linked problem with soft capsule prepared by gelatin alternative materials, without adding antioxidant.
Description
Technical field
The present invention relates to the technical field of medical industry production, the systems of especially a kind of soft capsule shell based on modified starch
Make the technical field of method.
Background technique
Soft capsule refers to medicinal substances extract, liquid medicine or is sealed after mixing with proper auxiliary materials with dropping preparation method or pressing
The dosage form of spherical, ellipse or other shapes is made in the soft shell of hydrophily.Soft capsule is suitable for unstable effective substance,
Such as light sensitive, volatility meets damp and hot unstable and oxidizable chemical component, is also suitble to have uncomfortable taste and bad odor
Effective substance.
Soft capsule is the common formulations of nutritional supplement and Western medicine, and soft capsule has become the direction of innovation of Chinese medicinal dosage form
One of, capsule shells prescription includes sizing material, plasticizer, water, four substance of additives, and sizing material is the main component for constituting softgel shell,
Such as gelatin and gelatin alternative materials etc.；Plasticizer often uses glycerol, polyalcohol, is used alone or as a mixture；Additives packet
Preservative, colorant, disintegrating agent, opacifier, antioxidant etc. are included, to keep the quality stability of drug and soft capsule dosage form.It passes
The production method of the soft capsule shell based on modified starch of system mainly includes gelatin, water, glycerol and selected pigment.
The sizing material of existing soft capsule shell includes: (1) cross-linking reaction due to the shortcomings that using gelatin: gelatin easily crosslinks instead
It answers, causes the unstable of soft capsule, as aldehyde, polyphenol, reduced sugar, multi-charge cation, electrolyte, cation or anion are poly-
Object etc. is closed, so that capsule mechanical performance or biological function be made to change.
(2) safety problem: gelatin is a kind of material from animal, skin, bone of the raw material sources in animal, and gelatin is
Object protein-colloid, and it is fatty on a small quantity containing animal.In recent years, with aftosa, rabid ox disease, bird flu generation, the peace of gelatin
Full property is increasingly under suspicion, and it cannot be received by some special culture persons and vegetarian.
(3) disintegration, leakage problems: often occurs disintegration time limited underproof problem within storage period, this phenomenon is mostly bright
Caused by glue aging crosslinking.Storage characteristics are also poor, and long-term storage can cause softgel shell to become fragile because of dehydration.It is hydrophilic due to gelatin
Property, it is easy water suction, dehydration, prevents from absorbing the moisture in medical fluid in soft capsule and causing capsule deformation and leakage, loading amount unqualified,
Gelatin can not be used for the package of hydrophily or drug easy to moisture absorption.
Summary of the invention
The object of the invention is to solve the problems of the prior art, a kind of soft capsule shell based on modified starch is proposed
Production method overcomes many disadvantages of gelatin, and property is relatively stable, is not susceptible to crosslinking phenomena, securely and reliably, storge quality
It is good.
To achieve the goals above, present applicant proposes a kind of production method of soft capsule shell based on modified starch, packets
Include modified starch, carragheen, plasticizer, water, thickener, the weight percent of each component are as follows:
Modified starch 25~75%；
Carragheen 10~30%；
Plasticizer 10~25%；
Water 10~20%；
Thickener 2~12%；
Pigment added by the color of soft capsule capsule and pill as needed.
The present invention is overcome bright by the way that the main component gelatin of conventional capsules capsule material is substituted for modified starch and carragheen
Many disadvantages of glue, modified starch have film performance, gas barrier, caking property etc., and security performance is high and has preferable elasticity,
Rate of dissolution is better than gelatin；The soft capsule prepared by modified starch and carragheen, property is relatively stable, and it is existing to be not susceptible to crosslinking
As, and there is no oxidation cross-linked problem with soft capsule prepared by gelatin alternative materials, without adding antioxidant.
Specific embodiment
In being described below, for illustration and not for limitation, the tool of such as particular system structure, technology etc is proposed
Body details, to understand thoroughly the embodiment of the present invention.However, it will be clear to one skilled in the art that there is no these specific
The present invention also may be implemented in the other embodiments of details.In other situations, it omits to well-known system, device, electricity
The detailed description of road and method, in case unnecessary details interferes description of the invention.
In order to illustrate technical solutions according to the invention, to achieve the above object, the invention proposes one kind based on modification
The production method of the soft capsule shell of starch, including modified starch, carragheen, plasticizer, water, thickener, the weight of each component
Measure percentage are as follows:
Modified starch 25~75%；
Carragheen 10~30%；
Plasticizer 10~25%；
Water 10~20%；
Thickener 2~12%；
Pigment added by the color of soft capsule capsule and pill as needed.
Preferably, the modified starch is PURE COTE, carragheen is that kappa-carrageenan and ι-carragheen are mixed
Object is closed, kappa-carrageenan and ι-carragheen ratio are 1:1.
Preferably, the plasticizer is glycerol and sorbierite, the ratio of glycerol and sorbierite be 0.4~0.6:0.4~
0.7。
Preferably, the thickener is seaweed glue and hydroxypropyl methylcellulose, the ratio of sodium alginate and hydroxypropyl methylcellulose
Example is 8.5~11.5:0.005~0.015.
Preferably, the water used is the purifying of distillation equipment, ion-exchange unit or reverse osmosis equipment preparation
Water.
Preferably, the pigment determines that the color of capsule, the type and dosage of pigment are determined by capsule color, such as
1000 blue capsules need brilliant blue 0.132g, and whole red capsule needs famille rose 0.128g, white portion do not use pigment and
Using titanium dioxide mother liquor, pigment and titanium dioxide mother liquor is then not added in full impregnated ' Yanming ' capsules for clearing.
Non- soft-gelatin softgel shell is all multi-party in addition to dissolubility to be considered, stability, bioavailability, safety and appearance etc.
Face, it is also contemplated that its processing characteristics.Common hydrophilic colloid includes carragheen, agar, seaweed glue, gellan gum, locust bean gum, HPMC
Modified starch, stroma starch etc., these common hydrophilic colloids are slightly worse than gelatin in comprehensive performance, using them as the master of softgel shell
Usually there is the problems such as softness, intensity, transparency and stability in the soft capsule for wanting raw material to prepare, need to carry out cooperation and technique
Adjustment.
On the other hand, modified starch is compounded with gellan gum can be used for preparing non-gelatin soft capsule, different acyl gellan gums
The property of the mixture formed with starch and plasticizer finds that the mixture and gelatin have similar structures and functional characteristic, system
Standby film has high mode and superior strength and extensibility, and can be used to prepare the good soft capsule of leakproofness.High acyl group
For improving elasticity, low-acyl gellan gum is then used to improve rigidity gellan gum, strong needed for can get by the two proportion appropriate
The gel of the performances such as degree and modulus.Starch is mainly used for obtaining required viscosity and film thickness.
It is as follows to the analytic explanation of each ingredient:
A) property of modified starch
Starch is a kind of polysaccharide, and individual native starch is generally difficult to prepare soft capsule, generallys use modified starch,
Or edible glue appropriate and plasticizer are compounded, ative starch is after chemical modification appropriate and enzyme modification processing, in various degree
Ground changes the physically or chemically characteristic of its original starch molecule, to obtain suitable capsule casing material.The chemical modification of starch
Mainly have etherificate, esterification, oxidation, cationization etc., the common enzyme of enzyme modification mainly have hydrolase, amylomaltase,
Glycogen branching enzyme, carbohydrase etc..Modified starch does not dissolve in cold water, ethyl alcohol and ether, is dissolved or dispersed in boiling water, forms colloid
Solution or emulsion liquid.By modifying the property (elasticity, mechanical strength) for becoming modified starch and just having similar gelatin, selection is closed
The soft capsule of suitable modified starch preparation can achieve gelatin soft capsule 80% or higher characteristic.
The preferred chemical modification of starch includes hydroxypropylation, acetylating, ethylization.The soft capsule wall prepared in this way
Thickness can be reduced to 100 μm, can extend to 200%, and intensity value reaches 5MPa, prepare soft capsule, preferably hydroxypropyl, ethoxy, amber
The modified starches such as amber acid esters and acetate, Acid modified starch have gelation stable under low viscosity, high concentration, and have good
Chewiness and elasticity.Studies have shown that starch softgel shell water content under the conditions of different humidity is relatively stable, even if in higher levels of humidity
Under the conditions of, capsule is still able to maintain good face shaping, hardness and elastic stage appropriate, without tacky phenomenon.Month
Between grass oil easily aoxidize in air, under the factors such as air, light, heat, between the moon in starch soft capsule grass oil oxidation number simultaneously
It does not vary widely, illustrates that starch soft capsule has good barrier property, and more stable.
B) carragheen
Modified starch is able to satisfy some characteristics for preparing soft capsule, such as good film forming, adhesivity and flexibility, dry
Speed is fast and odorlessness etc., but is also likely to be present the problems such as poor transparency, gelling temp are excessively high, melting temperature is excessively high simultaneously,
Softgel shell of good performance can be mixed by being properly added edible glue, and studying at present more is answering for modified starch and carragheen
Match.
Carragheen is also known as carrageenan, is the polysaccharide natural plant gum extracted from the thalassophytes such as Bostrychia montagnei, be divided into κ-,
3 kinds of ι-, lambda-carrageenan can generate synergistic effect with many colloids, to increase system viscosity, gel strength and elasticity.Inhomogeneity
The thickening of the carragheen of type and gelling property are very different.For example, κ type carragheen and the hard of potassium ion formation coagulate
Glue, and ι and λ only have minimal effect.ι type carragheen and calcium ion phase interaction form softness, flexible gel, but salt pair
It is not influenced in the property of λ type carragheen.In most cases, λ type and κ type are used together in milk systems obtains one kind
Suspension or cream gel.Carragheen and its mixture, which provide a large amount of benign species, causes generation a large amount of in extensive range and complicated
Commercial product be most suitable for specific application to meet unique comprehensive performance.Carragheen is in food and medicine industry usually by it
As thickener, gelling agent, suspending agent, emulsifier and stabilizer etc..
During realizing technical scheme, be conducive to improve it is found by the applicant that carragheen is compounded with modified starch
Gelling performance.For example, when the light transmittance of pure OK a karaoke club glue film is 78.5%, with the increase of starch additive amount, the two blend film
Light transmittance gradually decrease.When content of starch is 70%, the light transmittance of blend film only has 29.2%.This is because the knot of starch
Brilliant degree is higher, and refraction and reflection occurs in crystal boundary when light passes through crystalline region, reduces light transmittance.Moreover, with forming sediment in carragheen
The tensile strength presentation of the increase of powder content, blend film first increases the trend dropped afterwards.By the proportion of both control, can obtain
Photosensitiveness and the preferable film of intensity.
C) property of sorbierite
Sorbierite also known as D-sorbite, Sorbitol, hexahydric alcohol etc., appearance are white powder or crystalline powder, molecule
Formula is C6H14O6, is slightly soluble in ethyl alcohol and acetic acid.There is refrigerant sweet taste, sugariness is about the half of sucrose, and calorific value is close with sucrose.
It is soluble easily in water, it is insoluble in organic solvent, it is acidproof, and heat resistance is good, and with amino acid, protein etc. has been not easy Maillard reaction.
With good performance of keeping humidity, food can be made to keep certain moisture, prevent drying, can also prevent sugar, the precipitations such as salt crystallization, energy
Sweet tea is kept, acid, the balance of bitterness intensity enhances the flavor of food, since it is nonvolatile polyalcohol, so there are also keep food
The function of product fragrance.
Sorbierite has very big hygroscopicity, is not easy crystallization in aqueous solution and is precipitated, can boil together each metal ion species.Due to
There is no reproducibility group in molecule, chemical property is stablized in general, it does not work with soda acid, not vulnerable to air oxidation,
Also it is not easy that Mei Lade brown stain occurs with soluble Amino compound.Sorbierite is more much higher than corresponding sugar to better heat stability,
Mass fraction is up to 60% or more just not vulnerable to microbial attack.Sorbierite enters internal energy metabolism, belongs to nutritive sweetener, but its generation
Thanking to approach first is slowly to spread and be absorbed and be oxidized to fructose, then be utilized, and fructose metabolism pathway is participated in, to blood glucose value and urine
Sugar does not influence, and the sweetener that can be used as diabetes patient uses.
Sorbierite can reduce intracranial pressure, prevent oedema, can be used as drug and directly use, and can be used for the normal water of cardiorenal function
Swollen symptom.Sorbierite can also promote gallbladder contraction and cholagogue, increase choleresis；Stimulating pancreas secretes pancreatic lipase etc.,
Promote insulin releasing, can also accelerate small bowel peristalsis and absorption, therefore chronic liver and gallbladder, gastrointestinal disease symptom can be improved.
The purpose that plasticizer is added is the plasticity of increase colloidal materials, guarantees that the softgel shell of soft capsule products is soft, rich
It is flexible.Common plasticizer includes glycerol and polyalcohol.Glycerol viscosity is low, is easily uniformly dispersed.Glycerol can be with many colloids
Material all has good compatibility.Glycerol is as plasticizer, even if diffusion admittance is blocked by some solid particles, or makes to be filled out
The liquid viscosity filled increases, and glycerol is still enough to spread ethyl alcohol wherein.Common polyalcohol such as xylitol, sorbierite, hydrogenation is beautiful
Rice & peanut milk etc..Polyalcohol replaces glycerol to make plasticizer, and the migration of ethyl alcohol can obviously be inhibited.Reason is that glycerol and ethyl alcohol can be completely
It is miscible, and these polyalcohols slightly soluble in ethanol.Using glycerol as the softgel shell of plasticizer, its oxygen penetration power is strong.Sorbierite is selected to make
Plasticizer can reduce the penetration power of oxygen, to prevent the too fast aging of softgel shell；However, sorbierite will increase softgel shell hardness and its dissolution
Time, therefore glycerol is preferably used in mixed way with sorbierite.Glycerol and sorbierite are shared and can farthest be reduced in gelatin soft capsule
The mutual migration of softgel shell and content component.
D) property of seaweed glue
Seaweed glue also known as algin, sodium alginate, Sodium Alginate, Sodium Alginate, sodium alginate, seaweed gel etc., seaweed glue are one
Kind natural polysaccharide, is extracted from natural seaweed, stability, dissolubility, viscosity and peace needed for having pharmaceutical preparation auxiliary material
Quan Xing.The ability that it has concentrate solution, forms gel and film forming.Seaweed glue is dissolved in water, insoluble in ethyl alcohol, ether, chloroform etc.
Organic solvent.Water is dissolved in into viscous liquid, and 1% pH value of water solution is 6-8.It is viscosity stabilized as pH=6-9, it is heated to 80 DEG C
Then viscosity reduces when above.Its mild sol-gel process, good biocompatibility make seaweed glue be suitable for release or
The capsule of embedding medicinal, albumen and cell.Seaweed glue has hygroscopicity, when balance contained humidity number depend on it is relatively wet
Degree.Dry seaweed glue is quite stable in 25 DEG C and following temperature storage in the container of good seal.
Seaweed glue is not only a kind of safe food additives, and can be used as the substrate of remedy diet, since it is practical
On be a natural fiber element, the absorption of fatty sugar and cholate can be slowed down, have reduce serum cholesterol, in blood triglycerides and
The effect of blood glucose, can the modern diseases such as preventing hypertension, diabetes, obesity.It can inhibit in enteron aisle poisonous metal such as strontium,
The accumulation in vivo such as cadmium, lead, exactly because these important function of sodium alginate, are at home and abroad increasingly valued by the people.
For increasing blood volume and maintaining blood pressure, burn generated histamine toxoid and wound blood loss, operation are excluded
The dehydration of the whole bodies such as stabilization, bleeding profusely property shock, burn shock, high fever and the acute dysentery of the front and back circulatory system, treatment effect
Fruit is good.Also have excrete cholesterol, inhibit Pb, Cd, Sr be absorbed by the body and protect gastrointestinal tract, whole intestines, weight-reducing,
Hypoglycemic effect.Suspending agent, emulsifier, sticky dose, the capsule material of micro-capsule etc. are mainly used as on medicament.Seaweed glue is used as tablet
Adhesive, influence of the seaweed glue to tabletting properties depends on the amount that is put into prescription, and in some cases, seaweed glue can
Promote the disintegration of tablet.Seaweed glue can be added during granulation, and such manufacturing process is simpler.
E) property of hydroxypropyl methylcellulose
Hydroxypropyl methyl cellulose also known as hydroxypropyl methylcellulose, cellulose hydroxypropyl methyl ether, English name abbreviation HPMC,
It is to select the gossypin of high purity as raw material, is specially etherified and is made under alkaline condition, appearance is white or class
White powder.It is non-ionic celluloses ether without any animal organ and grease isoreactivity ingredient, appearance is the powder of white
End, it is odorless tasteless.It is safe and non-toxic, food additives can be made, empty calory is non-stimulated to skin, mucous membrane contact.
Hydroxypropyl methyl cellulose is water-soluble, and aqueous solution has surface-active, and transparency is high, performance is stablized.HPMC tool
There is thermal gels property, form gel after the heating of product aqueous solution and be precipitated, is dissolved again after cooling, the product gelling temp of different size
It is different.Solubility changes with viscosity, and viscosity is lower, and solubility is bigger.HPMC also has a thickening capabilities, salt tolerance low ash powder,
PH stability, water-retaining property, dimensional stability, excellent film forming and extensive resistance to enzymatic, dispersibility and caking property etc. are special
Point.
Beneficial effects of the present invention:
1, the present invention is overcome by the way that the main component gelatin of conventional capsules capsule material is substituted for modified starch and carragheen
Many disadvantages of gelatin, such as animal origin it is not safe enough, easy to moisture absorption easily crosslink reaction, storge quality difference.Modified starch
With film performance, gas barrier, caking property etc., security performance is high and has preferable elasticity, and rate of dissolution is better than gelatin.Addition
The modified starch of carragheen, improves film strength and speed, and reduce gelling temp and melting temperature.It is formed sediment by modified
The soft capsule of powder and carragheen preparation, property is relatively stable, is not susceptible to crosslinking phenomena, and prepared with gelatin alternative materials
Soft capsule does not have oxidation cross-linked problem, without adding antioxidant.
2, sorbierite is added in this capsule material formula, the inherently good plasticizer of sorbierite has good moisturizing effect
Fruit can make soft capsule keep certain moisture, can effectively prevent soft capsule drying, aging, improve the moisture retention of soft capsule, together
When sorbierite the preparation that also there is defoaming effect to be conducive to capsule material.Often individually use glycerol as plasticizer, glycerol in conventional formulation
The big then softgel shell of dosage is softer, and the easy moisture absorption is pressurized easily-deformable, and drying time is long；The too small softgel shell of dosage is brittle, after leading to capsule and pill
Phase leakage.Sorbierite is such as used alone, plasticity is worse than glycerol, and sorbierite cost is higher than glycerol, and due to its Water-saving effect
Good, capsule and pill is not easy drying, and capsule and pill surface will appear adhesion feeling.
It, not only can be to avoid problem above when being used in mixed way, moreover it is possible to good control material transport well.Glycerol belongs to low member
Alcohol, molecular weight is lower, if be used alone, intermolecular gap is more, and oxygen can pass freely through, and increases being oxidized for content
Probability, small-molecule substance such as hydrone can also pass freely through, and substance generates migration, lead to loading amount problem.Sorbierite belongs to polynary
Alcohol, molecular weight is larger, is used in mixed way, and not only reduces intermolecular gap, prevents oxygen reaction and the generation of material transport.And
Drying time also shortens, and increases capsule and pill plasticity, guarantees product quality.
3, capsule material formula addition thickener seaweed glue, hydroxypropyl methylcellulose improve gelatin viscosity, can properly increase flexible glue
The flexibility and elasticity of capsule, make its stomach and intestine presumptive area dissolve, discharge content, capsule can be made to be disintegrated rapidly, stability is good,
Water content is low.
Feature and advantage of the invention will be described in detail by embodiment.
A kind of production method of the soft capsule shell based on modified starch of the present invention, including modified starch, carragheen, plasticising
Agent, water, thickener, the weight percent of each component are as follows:
Modified starch 25~75%；
Carragheen 10~30%；
Plasticizer 10~25%；
Water 10~20%；
Thickener 2~12%；
Pigment added by the color of soft capsule capsule and pill as needed.
The modified starch is PURE COTE, and carragheen is kappa-carrageenan and ι-carragheen mixture, κ-card
It draws glue and ι-carragheen ratio is 1:1.The plasticizer is glycerol and sorbierite, the ratio of glycerol and sorbierite is 0.4~
0.6:0.4~0.7.The thickener is seaweed glue and hydroxypropyl methylcellulose, and the ratio of sodium alginate and hydroxypropyl methylcellulose is
8.5~11.5:0.005~0.015.The water used is distillation equipment, ion-exchange unit or reverse osmosis equipment preparation
Purified water.The pigment determines the color of capsule, and the type and dosage of pigment are determined by capsule color, such as 1000 blues
Capsule needs brilliant blue 0.132g, and whole red capsule needs famille rose 0.128g, and white portion uses titanium dioxide without using pigment
Pigment and titanium dioxide mother liquor is then not added in titanium mother liquor, full impregnated ' Yanming ' capsules for clearing.
Embodiment:
First purified water 40kg, glycerol 22kg and sorbierite 18kg are put into glue pot, close feeding port, stirring will mix
It closes liquid temperature and rises to 60 DEG C, entire sol-process guarantees interlayer coolant-temperature gage at 60 DEG C~80 DEG C.
Then PURE COTE 50kg, kappa-carrageenan 10kg, ι-carragheen is added to glue pot while stirring
10kg, seaweed glue 8kg, hydroxypropyl methylcellulose 0.1kg, control investment speed prevents conglomeration, colloidal sol is carried out under vacuumized conditions, molten
Solving the time is 1 hour.
Pigment 0.3kg is put into glue with after hot water dissolving again, opacifier titanium dioxide is made into mother liquor investment glue,
It stirs evenly.
Sample detection gelatin viscosity, moisture close gas outlet when viscosity number 18000pa.s moisture is 36.8%, locking is thrown
Material mouth is passed through compressed air into glue pot, is putting the filter bag filter glue liquid that 120 mesh or more are bound at Jiao Kou.Glue is put into pre-
It first keeps the temperature in 60 DEG C of glue-storing barrel, glue carries out pelleting compacting with Soft Capsule Machinery after 60 DEG C of heat preservation defoamings stand 4 hours.
The present invention is overcome by the way that the main component gelatin of conventional capsules capsule material is substituted for modified starch and carragheen
Many disadvantages of gelatin, such as animal origin it is not safe enough, easy to moisture absorption easily crosslink reaction, storge quality difference.Modified starch
With film performance, gas barrier, caking property etc., security performance is high and has preferable elasticity, and rate of dissolution is better than gelatin.Addition
The modified starch of carragheen, improves film strength and speed, and reduce gelling temp and melting temperature.It is formed sediment by modified
The soft capsule of powder and carragheen preparation, property is relatively stable, is not susceptible to crosslinking phenomena, and prepared with gelatin alternative materials
Soft capsule does not have oxidation cross-linked problem, without adding antioxidant.
Sorbierite is added in this capsule material formula, the inherently good plasticizer of sorbierite has good moistening effect,
Soft capsule can be made to keep certain moisture, soft capsule drying, aging is can effectively prevent, improve the moisture retention of soft capsule, simultaneously
The preparation that also there is sorbierite defoaming effect to be conducive to capsule material.Often individually use glycerol as plasticizer in conventional formulation, glycerol is used
Measured big then softgel shell it is softer, the easy moisture absorption is pressurized easily-deformable, and drying time is long；The too small softgel shell of dosage is brittle, leads to the capsule and pill later period
Leakage.Sorbierite is such as used alone, plasticity is worse than glycerol, and sorbierite cost is higher than glycerol, and since its Water-saving effect is good,
Capsule and pill is not easy drying, and capsule and pill surface will appear adhesion feeling.
It, not only can be to avoid problem above when being used in mixed way, moreover it is possible to good control material transport well.Glycerol belongs to low member
Alcohol, molecular weight is lower, if be used alone, intermolecular gap is more, and oxygen can pass freely through, and increases being oxidized for content
Probability, small-molecule substance such as hydrone can also pass freely through, and substance generates migration, lead to loading amount problem.Sorbierite belongs to polynary
Alcohol, molecular weight is larger, is used in mixed way, and not only reduces intermolecular gap, prevents oxygen reaction and the generation of material transport.And
Drying time also shortens, and increases capsule and pill plasticity, guarantees product quality.
Capsule material formula adds thickener seaweed glue, hydroxypropyl methylcellulose improves gelatin viscosity, can properly increase soft capsule
Flexibility and elasticity, make its stomach and intestine presumptive area dissolve, discharge content, capsule can be made to be disintegrated rapidly, stability is good, contains
Water is low.
Above-described embodiment is the description of the invention, is not limitation of the invention, after any pair of simple transformation of the present invention
Scheme all belong to the scope of protection of the present invention.
Claims (6)
1. a kind of production method of the soft capsule shell based on modified starch, including modified starch, carragheen, plasticizer, water, thickening
Agent,
The weight percent of each component are as follows:
Modified starch 25~75%；
Carragheen 10~30%；
Plasticizer 10~25%；
Water 10~20%；
Thickener 2~12%；
Pigment added by the color of soft capsule capsule and pill as needed.
2. a kind of production method of the soft capsule shell based on modified starch as described in claim 1, it is characterised in that: described to change
Property starch be PURE COTE, carragheen is kappa-carrageenan and ι-carragheen mixture, kappa-carrageenan and ι-carragheen
Ratio be 1:1.
3. a kind of production method of the soft capsule shell based on modified starch as described in claim 1, it is characterised in that: the increasing
Agent is moulded as glycerol and sorbierite, the ratio of glycerol and sorbierite is 0.4~0.6:0.4~0.7.
4. a kind of production method of the soft capsule shell based on modified starch as described in claim 1, it is characterised in that: the increasing
Thick dose is seaweed glue and hydroxypropyl methylcellulose, the ratio of sodium alginate and hydroxypropyl methylcellulose be 8.5~11.5:0.005~
0.015。
5. a kind of production method of the soft capsule shell based on modified starch as described in claim 1, it is characterised in that: described to make
Water is the purified water of distillation equipment, ion-exchange unit or reverse osmosis equipment preparation.
6. a kind of production method of soft capsule shell based on modified starch as described in any one of claims 1 to 5, feature
Be: the pigment determines that the color of capsule, the type and dosage of pigment are determined by capsule color, such as 1000 blue capsules
Brilliant blue 0.132g is needed, whole red capsule needs famille rose 0.128g, and white portion uses titanium dioxide female without using pigment
Pigment and titanium dioxide mother liquor is then not added in liquid, full impregnated ' Yanming ' capsules for clearing.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910605404.6A CN110169955A (en) | 2019-07-05 | 2019-07-05 | A kind of production method of the soft capsule shell based on modified starch |
Applications Claiming Priority (1)
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111388442A (en) * | 2020-03-24 | 2020-07-10 | 广州普正生物科技有限公司 | Gel candy type plant soft capsule |
| CN112386583A (en) * | 2020-12-15 | 2021-02-23 | 陕西中医药大学 | Method for manufacturing soft capsule shell based on modified gelatin |
| CN114504563A (en) * | 2022-02-23 | 2022-05-17 | 博睿先锋(北京)生物科技有限公司 | Chlorogenic acid self-emulsifying composition capsule and preparation method thereof |
| CN114642648A (en) * | 2022-04-26 | 2022-06-21 | 仙乐健康科技股份有限公司 | Starch film-forming composition and application thereof in soft capsules |
| CN115844849A (en) * | 2022-12-27 | 2023-03-28 | 山东赫尔希胶囊有限公司 | Cellulose plant soft capsule and its preparation method |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104337931A (en) * | 2013-08-07 | 2015-02-11 | 洪艳平 | Medicated wine capable of treating tinnitus |
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2019
- 2019-07-05 CN CN201910605404.6A patent/CN110169955A/en not_active Withdrawn
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104337931A (en) * | 2013-08-07 | 2015-02-11 | 洪艳平 | Medicated wine capable of treating tinnitus |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111388442A (en) * | 2020-03-24 | 2020-07-10 | 广州普正生物科技有限公司 | Gel candy type plant soft capsule |
| CN112386583A (en) * | 2020-12-15 | 2021-02-23 | 陕西中医药大学 | Method for manufacturing soft capsule shell based on modified gelatin |
| CN114504563A (en) * | 2022-02-23 | 2022-05-17 | 博睿先锋(北京)生物科技有限公司 | Chlorogenic acid self-emulsifying composition capsule and preparation method thereof |
| CN114642648A (en) * | 2022-04-26 | 2022-06-21 | 仙乐健康科技股份有限公司 | Starch film-forming composition and application thereof in soft capsules |
| CN114642648B (en) * | 2022-04-26 | 2023-10-03 | 仙乐健康科技股份有限公司 | Starch film forming composition and application thereof in soft capsules |
| CN115844849A (en) * | 2022-12-27 | 2023-03-28 | 山东赫尔希胶囊有限公司 | Cellulose plant soft capsule and its preparation method |
| CN115844849B (en) * | 2022-12-27 | 2024-03-15 | 山东赫尔希胶囊有限公司 | Cellulose plant soft capsule and preparation method thereof |
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