CN109675044A - A kind of thin film coating material and its preparation method and application - Google Patents
A kind of thin film coating material and its preparation method and application Download PDFInfo
- Publication number
- CN109675044A CN109675044A CN201910067352.1A CN201910067352A CN109675044A CN 109675044 A CN109675044 A CN 109675044A CN 201910067352 A CN201910067352 A CN 201910067352A CN 109675044 A CN109675044 A CN 109675044A
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- coating material
- starch
- preparation
- sodium alginate
- octenyl succinate
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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
- A61K9/50—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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21062—Subtilisin (3.4.21.62)
Abstract
The invention discloses a kind of thin film coating materials and its preparation method and application, and steps are as follows for the preparation method: by degree of substitution be 0.01-0.30, molecular weight is 1 × 106‑5×104The starch octenyl succinate anhydride of g/mol adds water to be made into starch milk and be sufficiently gelatinized, and then adding molecular weight is 3.0 × 106‑1×104Then the sodium alginate and food-grade plasticizer of g/mol heats 1-4h at 70-90 DEG C, obtains coating material through high pressure microjet homogenization.There is the laminated film coating material small intestine target controlling and releasing characteristic can effectively avoid the problem that bioactive ingredients inactivate under one's belt for the small intestine Targeting delivery of bioactive substance.
Description
Technical field
The present invention relates to a kind of laminated film coating material, refer in particular to specific starch octenyl succinate anhydride and specific
Sodium alginate is thin film coating material and its application that one kind that substrate is prepared can have small intestine target controlling and releasing behavior.
Background technique
With the development of society, ordinary meal should also have one other than sustaining life, meeting the basic demand of sense organ
The function of fixed nutrition and prevention disease, to meet requirement of the people to life and health.Given activity ingredient includes function factor
And pharmaceutical activity molecule plays important regulative in the maintenance of national health level, reinforces such given activity ingredient in vivo
Stable stateization conveying is the fields such as food science, drug delivery one of critical issue urgently to be resolved.In addition, active constituent exists
The specific target spot conveying of small intestine is equally particularly important one of problem in science.For example, Nattokinase under one's belt may by enzymatic hydrolysis and
It loses activity, and is significantly stronger than duodenum in the absorption efficiency of jejunum and ileum；The oral medication of the specific damaged part of small intestine
Drug target release also requires that the specific target spot control sustained release behavior of the small intestine of content carrier with absorption.Develop and create specific work
The small intestine target controlling and releasing carrier of property ingredient is most important.
Film coating carrier, including coated particles, pellet or tablet etc. are the important hands of daily intake given activity ingredient
One of section.To reach enteron aisle specific site target controlling and releasing behavior, the design of coating material should be with the overriding concern factor compounded
The film forming of thin film coating material, followed by the active constituent ingredient before not reaching release target spot are not revealed, do not lose activity, most
It is the effective component release in specific target spot afterwards.Disclose application No. is 201611229104.5 patent " a kind of composition and
Its application as coating material ", which is compounded using sea grass polysaccharide with sodium alginate simple physical, while being aided with CaCl2
The crosslinked action of solution can delay inactivation and release of the coated systems content in gastric juice, while improve content enteral
Releasing degree.Wang X.Y. et al. is in " Preparation and characterisation of octenyl
succinate starch as a delivery carrier for bioactive food components(Food
Chemistry, 2011,126 (3): 1218-1225) a text introduction, carrying out octenyl succinic acid anhydride modification to starch can effectively mention
The film forming and hydrophobicity of high starch, and then improve inactivation and release of the coating content in gastric juice.However, natural polysaccharide is general
It is coated film forming and mechanical performance is poor, hydrophily is stronger, the i.e. swelling or by gastric acid Partial digestion in gastric juice, so that coating system
Content of uniting is larger in the burst size of upper digestion and intelligent poor in the response of small intestine；Hydrophobic modification starch can rely on it
The corresponding type coated systems of enzyme are designed the degradability of enteron aisle starch digestion enzyme system, however construct distal small intestine targeted system institute
High substituted degree modified starch is needed generally to carry out in the organic solvents such as pyridine, it is cumbersome and face certain toxicity.
With advances in technology with the enhancing of environmental consciousness, easy to operate, environmentally protective technology is by each industrialization at present
It is praised highly in field.Zheng M.J. et al. is in " Effect of guar gum on the physicochemical
properties and in vitro digestibility of lotus seed starch(Food Chemistry,
2019,272:286-291) " Wen Faxian is added natural polysaccharide in starch gelatinization system and starch is effectively reduced to starch digestion
The susceptibility of enzyme.It is a kind of green to the susceptibility of alimentary canal starch digestion enzyme system using simple physical blending technology regulation starch
The good means of environmental protection, safety.But for the coating material for having small intestine target controlling and releasing behavior, do not require nothing more than coating material
Resistance to enzymolysis ability with certain digestive enzyme, while coating material being required to have preferable compatibility to avoid coating membrane appearance
It mutually separates and does not tolerate destruction of the gastric juice to content.Therefore, by polysaccharide blend system construction coating material to polysaccharide and more
The compatibility of sugar proposes new requirement.
Summary of the invention
In view of the above-mentioned problems existing in the prior art, primary and foremost purpose of the present invention is to provide a kind of utilization low degree of substitution octene
Base succinic acid starch ester is compounded with sodium alginate lower prepares a kind of film packet with small intestine target controlling and releasing behavior high-pressure homogeneous
The method of clothing material, hydrophobicity, film forming and the film forming for improving starch to the modification of starch by octenyl succinic acid anhydride are mechanical
Performance by compounding intelligent response behavior of the regulation starch to small intestine Digest enzyme with sodium alginate, while utilizing high-pressure homogeneous
Barometric gradient, fluid shearing, turbulent flow, cavitation effect and the friction of generation, shock etc. promote the compatible of two kinds of polysaccharide,
To overcome the shortcomings of coating material hydrophobic performance, filming performance, intestinal enzymes respondent behavior and polysaccharide compatibility, a kind of utilization is obtained
The preparation method of easy to operate, the environmentally protective thin film coating material with the behavior of small intestine target controlling and releasing.
In order to achieve the above objectives, this invention takes following technical schemes:
A kind of preparation method of thin film coating material, comprising the following steps:
By degree of substitution be 0.01-0.30, molecular weight is 1 × 106-5×104The starch octenyl succinate anhydride of g/mol adds water
It is made into starch milk and is sufficiently gelatinized, then adding molecular weight is 3.0 × 106-1×104The sodium alginate and food-grade of g/mol increases
Agent is moulded, through high pressure microjet homogenization, then 1-4h is heated at 70-90 DEG C, obtains coating material.
Preferably, the high pressure microjet homogenization condition is homogenization pressure: 20-60MPa, homogenisation cycle processing time
Number: 2-6 times.
Preferably, the high pressure microjet homogenization condition is homogenization pressure: 30-50MPa, homogenisation cycle processing time
Number: 3-5 times.
Preferably, the additive amount of the starch octenyl succinate anhydride is (3-15) % of coating material gross mass；It is described
The additive amount of sodium alginate is (1-10) % of coating material gross mass；The additive amount of the plasticizer is coating material gross mass
(0.5-5) %.
Preferably, the additive amount of the starch octenyl succinate anhydride is (7-13) % of coating material gross mass；It is described
The additive amount of sodium alginate is (3-5) % of coating material gross mass；The additive amount of the plasticizer is coating material gross mass
(2-4) %.
Preferably, the mass ratio of the starch octenyl succinate anhydride and sodium alginate is 4:1~3:1.
Preferably, the plasticizer includes one or both of sorbierite, glycerol.
Preferably, the starch octenyl succinate anhydride is ocentyl succinic cornstarch ester, ocentyl succinic horse
One or more of bell sweet potato starch ester, tapioca starch sodium octenyl succinate.
Preferably, the mass fraction of the starch milk is 3~15%.The mass fraction of more preferable starch milk is 10%.
Compared to current enteric carrier, the technical formula is simple, technique is clear, is only formed sediment by regulation ocentyl succinic
The molecular weight of powder ester degree of substitution, molecular weight and sodium alginate, and control high pressure microjet processing condition induce two kinds of polysaccharide phases
Hold, good film-forming property, the thin film coating material for having in alimentary canal certain enzyme degradation behavior can be obtained.
The thin film coating material that the above method is prepared can be used for the small intestine Targeting delivery of bioactive substance.This is multiple
Condensation material is suitable for the small intestine targeting of all film coating carriers including albumen, polyphenol and drug ingedient etc. for content
The regulation of release behavior, it is ensured that film coating carrier content object is in the stable state conveying of stomach and upper small intestine and jejunum and ileum
Fixed point release behavior.
Compared with prior art, the present invention has the following advantages and beneficial effects:
(1) present invention is specific containing specific degree of substitution, the starch octenyl succinate anhydride of specified molecular weight and tool by choosing
Means are blended with simple physical in the sodium alginate of molecular weight, compound appropriate plasticizer and apply high pressure microjet homogenization technology
A kind of thin film coating material with small intestine target controlling and releasing behavior can be obtained.The coating material can avoid containing content in stomach
Middle release and inactivate, but can target to be delivered to the specific target spot of small intestine and discharge and contain active constituent, solve active constituent in small intestine
The critical issue of specific target spot control sustained release.
(2) present invention is prepared thin with the compatibility and its mutual active force of simple physical blending adjusting two-phase polysaccharide
Film coating material, it is simple process, at low cost, the coating material good film-forming property that is prepared, targeting distal small intestine delivering activity at
Divide effect obvious, is easy to large scale preparation small intestine target spot enteric solubility coating carrier.
Specific embodiment
Below with reference to embodiment, the present invention is described in further detail, and embodiments of the present invention are not limited thereto.
Embodiment 1
Being respectively synthesized degree of substitution is 0.029, and molecular weight is respectively 1.259 × 106、2.341×105With 8.854 × 104g/
Mol and molecular weight are 2 × 105G/mol, the starch octenyl succinate anhydride of degree of substitution 0.012,0.029 and 0.039.It will system
Standby obtained converted starch is configured to the starch milk that mass fraction is 10%, is sufficiently gelatinized, the sorb of dextrin quality 2% is added
Alcohol is recycled homogeneous 3 times, 80 DEG C of heating 1h using high pressure homogenizer at 40MPa, imports mold and 45 DEG C of oven drying 12h systems
Standby starch film.Fast digestible starch (RDS), the slow-digestion starch of preparation-obtained starch film are measured using Englyst method
(SDS) and the following Tables 1 and 2 of resistant starch (RS) content.
1 different molecular weight starch octenyl succinate anhydride of table
2 different degree of substitution starch octenyl succinate anhydride of table
In addition, choosing degree of substitution is 0.029, molecular weight is 2 × 105The starch octenyl succinate anhydride of g/mol respectively with
The ratio and molecular weight of 8:0,8:1,8:2 and 8:3 are 3.0 × 106The sodium alginate of g/mol compounds, by above-mentioned steps addition 2%
Sorbierite prepare starch film；Meanwhile choosing molecular weight is 3.0 × 106The sodium alginate and degree of substitution of g/mol is 0.029, point
Other molecular weight is 1.259 × 106、2.341×105With 8.854 × 104G/mol and molecular weight are 2 × 105G/mol, degree of substitution
Starch octenyl succinate anhydride for 0.012,0.029 and 0.039 compounds respectively, by the sorbierite of step addition 2%, utilizes height
Pressure homogenizer recycles homogeneous 3 times at 40MPa, and 80 DEG C of heating 1h prepare starch film.Using prepared by the measurement of Englyst method
The fast digestion ingredient (RDC) of obtained starch film digests ingredient (SDC) and anti-digestion ingredient (RC) content such as the following table 3, table 4 slowly
With table 5.
The digestibility of the starch film of the different starch octenyl succinate anhydride/sodium alginate ratios of table 3
The digestibility for the starch film that 4 different degree of substitution starch octenyl succinate anhydride of table is compounded with sodium alginate
The digestibility for the starch film that 5 different molecular weight starch octenyl succinate anhydride of table is compounded with sodium alginate
There is table 1-5 it is found that degree of substitution and molecular weight, ocentyl succinic by regulation starch octenyl succinate anhydride form sediment
The film forming ratio of powder ester and sodium alginate and compounded with sodium alginate film forming starch octenyl succinate anhydride degree of substitution and point
Son amount can reach control film-forming coating materials in enzymatic behavior in the digestive tract.Show to choose tool specified molecular weight and degree of substitution
Starch octenyl succinate anhydride is compounded with the sodium alginate of tool specified molecular weight, good film-forming property can be prepared, in digestive enzyme
The controllable thin film coating material of rush behavior realizes the system of the thin film coating material of active constituent targeting small intestine specific site release
It is standby.
Embodiment 2
(1) the film coating liquid with the behavior of small intestine target controlling and releasing compounds:
Weighing 10g degree of substitution is 0.013, and molecular weight is 2.341 × 105The tapioca starch sodium octenyl succinate of g/mol
It is configured to the starch milk that mass fraction is 10%, after boiling water bath is sufficiently gelatinized, being separately added into 1.25,2.5 and 3.75g molecular weight is
3.0×1062g sorbierite sufficiently is added after compounding, using high pressure Microfluidizer at 30MPa in the sodium alginate of g/mol
Circulation homogenization 5 times, 75 DEG C of heating 2h, are prepared coating solution later.
(2) prepared by the film coating pellet with the behavior of small intestine target controlling and releasing:
Microcrystalline cellulose and Nattokinase (microcrystalline cellulose and Nattokinase mass ratio be 4:1) are sufficiently mixed, passed through
The capsule core of 0.7mm load Nattokinase is prepared in extrusion spheronization machine.Suitable blast pressure is selected using fluidized bed coating equipment
The techniques such as power, inlet air temperature, fluidized pressure, atomizing pressure, temperature of charge, coating flow velocity, the coating solution that step (1) is obtained
It is equably wrapped in preparation-obtained Nattokinase load capsule core, a kind of film packet of small intestine Targeting delivery Nattokinase is made
Clothing pellet.
The release behavior discovery of simulated digestive juice in vitro, by starch octenyl succinate anhydride and sodium alginate compound proportion
The coating micro-pill prepared for the coating solution of 8:1,8:2 and 8:3 can deliver the Nattokinase of about 36%, 54% and 60% small respectively
The specific target spot release of the small intestine of Nattokinase is realized in the release of intestines end；Meanwhile discovery passes through regulation starch octenyl succinate anhydride
It can control Nattokinase in gastral release behavior with the behavior that compounds of sodium alginate.
Embodiment 3
(1) the film coating liquid with the behavior of small intestine target controlling and releasing compounds:
Weighing 10g degree of substitution is 0.013, and molecular weight is 1.259 × 106The ocentyl succinic cornstarch ester of g/mol
It is configured to the starch milk that mass fraction is 8%, after boiling water bath is sufficiently gelatinized, it is 3.0 × 10 that 3.75g molecular weight, which is added,6G/mol's
Sodium alginate is sufficiently added 3g sorbierite after compounding, is recycled at 20MPa homogenization 6 times using high pressure Microfluidizer,
80 DEG C of heating 2h later, are prepared coating solution.
(2) prepared by the film coating pellet with the behavior of small intestine target controlling and releasing:
Microcrystalline cellulose and Nattokinase (microcrystalline cellulose and Nattokinase mass ratio be 4:1) are sufficiently mixed, passed through
The capsule core of 0.7mm load Nattokinase is prepared in extrusion spheronization machine.Suitable blast pressure is selected using fluidized bed coating equipment
The techniques such as power, inlet air temperature, fluidized pressure, atomizing pressure, temperature of charge, coating flow velocity, the coating solution that step (1) is obtained
It is equably wrapped in preparation-obtained Nattokinase load capsule core, a kind of film packet of small intestine Targeting delivery Nattokinase is made
Clothing pellet.
The release behavior discovery of simulated digestive juice, the pellet can deliver about 58% Nattokinase in distal small intestine in vitro
The specific target spot release of the small intestine of Nattokinase is realized in release.
Embodiment 4
(1) the film coating liquid with the behavior of small intestine target controlling and releasing compounds:
Weighing 10g degree of substitution is 0.039, and molecular weight is 1.1 × 106The octenylsuccinate potato starch ester of g/mol
It is configured to the starch milk that mass fraction is 13%, after boiling water bath is sufficiently gelatinized, it is 3.0 × 10 that 3.75g molecular weight, which is added,6g/mol
Sodium alginate, sufficiently compounding after be added 4g sorbierite, homogenization 4 is recycled at 40MPa using high pressure Microfluidizer
Secondary, 70 DEG C of heating 4h, are prepared coating solution later.
(2) prepared by the film coating pellet with the behavior of small intestine target controlling and releasing:
Microcrystalline cellulose and Nattokinase (microcrystalline cellulose and Nattokinase mass ratio be 4:1) are sufficiently mixed, passed through
The capsule core of 0.7mm load Nattokinase is prepared in extrusion spheronization machine.Suitable blast pressure is selected using fluidized bed coating equipment
The techniques such as power, inlet air temperature, fluidized pressure, atomizing pressure, temperature of charge, coating flow velocity, the coating solution that step (1) is obtained
It is equably wrapped in preparation-obtained Nattokinase load capsule core, a kind of film packet of small intestine Targeting delivery Nattokinase is made
Clothing pellet.
The release behavior discovery of simulated digestive juice, the pellet can deliver about 63% Nattokinase in distal small intestine in vitro
The specific target spot release of the small intestine of Nattokinase is realized in release.
Claims (10)
1. a kind of preparation method of thin film coating material, which comprises the following steps:
By degree of substitution be 0.01-0.30, molecular weight is 1 × 106-5×104The starch octenyl succinate anhydride of g/mol adds water to be made into
Starch milk is simultaneously sufficiently gelatinized, and then adding molecular weight is 3.0 × 106-1×104The sodium alginate and food-grade plasticizer of g/mol,
Through high pressure microjet homogenization, 1-4h then is heated at 70-90 DEG C, obtains coating material.
2. preparation method according to claim 1, it is characterised in that: the high pressure microjet homogenization condition is,
Matter pressure: 20-60MPa, homogenisation cycle number of processes: 2-6 times.
3. preparation method according to claim 2, it is characterised in that: the high pressure microjet homogenization condition is,
Matter pressure: 30-50MPa, homogenisation cycle number of processes: 3-5 times.
4. preparation method according to claim 3, it is characterised in that: the additive amount of the starch octenyl succinate anhydride is
(3-15) % of coating material gross mass；The additive amount of the sodium alginate is (1-10) % of coating material gross mass；It is described
The additive amount of plasticizer is (0.5-5) % of coating material gross mass.
5. the preparation method according to claim 4, it is characterised in that: the additive amount of the starch octenyl succinate anhydride is
(7-13) % of coating material gross mass；The additive amount of the sodium alginate is (3-5) % of coating material gross mass；The increasing
The additive amount for moulding agent is (2-4) % of coating material gross mass.
6. preparation method described described in any one according to claim 1~5, it is characterised in that: the octenyl succinic
The mass ratio of acid-starch ester and sodium alginate is 4:1~3:1.
7. preparation method according to claim 6, it is characterised in that: the plasticizer includes sorbierite, one in glycerol
Kind or two kinds.
8. preparation method according to claim 7, it is characterised in that: the starch octenyl succinate anhydride is octenyl amber
One or both of amber acid cornstarch ester, octenylsuccinate potato starch ester, tapioca starch sodium octenyl succinate
More than；The mass fraction of the starch milk is 3~15%.
9. the thin film coating material that the described in any item methods of claim 1-8 are prepared.
10. the application of thin film coating material as claimed in claim 9, it is characterised in that: the material is for bioactive substance
Small intestine Targeting delivery.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111035015A (en) * | 2019-12-27 | 2020-04-21 | 浙江新和成股份有限公司 | Water-insoluble fat-soluble nutrient microcapsule and preparation method thereof |
| CN112237632A (en) * | 2019-07-19 | 2021-01-19 | 宋艳 | Preparation method of ginseng-based film coating material |
| CN113768051A (en) * | 2020-06-09 | 2021-12-10 | 中粮营养健康研究院有限公司 | Feed additive, preparation method thereof, application of feed additive in feed and anti-feed |
| CN115300473A (en) * | 2022-04-12 | 2022-11-08 | 浙江海正动物保健品有限公司 | Compound taste-masking doxycycline hydrochloride chewable tablet and preparation method thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112237632A (en) * | 2019-07-19 | 2021-01-19 | 宋艳 | Preparation method of ginseng-based film coating material |
| CN111035015A (en) * | 2019-12-27 | 2020-04-21 | 浙江新和成股份有限公司 | Water-insoluble fat-soluble nutrient microcapsule and preparation method thereof |
| CN111035015B (en) * | 2019-12-27 | 2023-09-05 | 浙江新和成股份有限公司 | Non-water-soluble fat-soluble nutrient microcapsule and preparation method thereof |
| CN113768051A (en) * | 2020-06-09 | 2021-12-10 | 中粮营养健康研究院有限公司 | Feed additive, preparation method thereof, application of feed additive in feed and anti-feed |
| CN113768051B (en) * | 2020-06-09 | 2024-03-19 | 中粮营养健康研究院有限公司 | Feed additive, preparation method thereof, application of feed additive in feed and tianti feed |
| CN115300473A (en) * | 2022-04-12 | 2022-11-08 | 浙江海正动物保健品有限公司 | Compound taste-masking doxycycline hydrochloride chewable tablet and preparation method thereof |
| CN115300473B (en) * | 2022-04-12 | 2023-09-29 | 浙江海正动物保健品有限公司 | Compound taste-masking doxycycline hydrochloride chewable tablet and preparation method thereof |
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