CN108578704A - A kind of composition and its associated uses for swallowing - Google Patents
A kind of composition and its associated uses for swallowing Download PDFInfo
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- CN108578704A CN108578704A CN201810308505.2A CN201810308505A CN108578704A CN 108578704 A CN108578704 A CN 108578704A CN 201810308505 A CN201810308505 A CN 201810308505A CN 108578704 A CN108578704 A CN 108578704A
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- 239000000203 mixture Substances 0.000 title claims abstract description 89
- 230000009747 swallowing Effects 0.000 title abstract description 10
- 239000003814 drug Substances 0.000 claims abstract description 33
- 229940079593 drug Drugs 0.000 claims abstract description 27
- 235000013305 food Nutrition 0.000 claims description 25
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 19
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 15
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical group OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 14
- 238000002360 preparation method Methods 0.000 claims description 14
- 239000000499 gel Substances 0.000 claims description 13
- 239000000470 constituent Substances 0.000 claims description 10
- 201000010099 disease Diseases 0.000 claims description 10
- 239000000463 material Substances 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 10
- 230000009748 deglutition Effects 0.000 claims description 8
- 235000020357 syrup Nutrition 0.000 claims description 8
- 239000006188 syrup Substances 0.000 claims description 8
- 108010010803 Gelatin Proteins 0.000 claims description 7
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 7
- 240000008042 Zea mays Species 0.000 claims description 7
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 claims description 7
- 235000002017 Zea mays subsp mays Nutrition 0.000 claims description 7
- 235000010489 acacia gum Nutrition 0.000 claims description 7
- 239000001785 acacia senegal l. willd gum Substances 0.000 claims description 7
- 235000005822 corn Nutrition 0.000 claims description 7
- 239000008273 gelatin Substances 0.000 claims description 7
- 229920000159 gelatin Polymers 0.000 claims description 7
- 235000019322 gelatine Nutrition 0.000 claims description 7
- 235000011852 gelatine desserts Nutrition 0.000 claims description 7
- 235000011187 glycerol Nutrition 0.000 claims description 7
- 239000008103 glucose Substances 0.000 claims description 6
- 239000004615 ingredient Substances 0.000 claims description 6
- 239000000049 pigment Substances 0.000 claims description 6
- 239000002552 dosage form Substances 0.000 claims description 5
- 239000002775 capsule Substances 0.000 claims description 4
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 239000008187 granular material Substances 0.000 claims description 4
- 229940126701 oral medication Drugs 0.000 claims description 4
- 239000004014 plasticizer Substances 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 4
- 239000003826 tablet Substances 0.000 claims description 4
- 150000001720 carbohydrates Chemical class 0.000 claims description 3
- 235000014633 carbohydrates Nutrition 0.000 claims description 3
- 238000001647 drug administration Methods 0.000 claims description 3
- 229930091371 Fructose Natural products 0.000 claims description 2
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 2
- 239000005715 Fructose Substances 0.000 claims description 2
- 229920002472 Starch Polymers 0.000 claims description 2
- 235000010418 carrageenan Nutrition 0.000 claims description 2
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- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
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- 230000008859 change Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
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- 238000005516 engineering process Methods 0.000 description 2
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- 238000010998 test method Methods 0.000 description 2
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
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- 241000965606 Saccopharyngidae Species 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
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- 238000004090 dissolution Methods 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 235000012041 food component Nutrition 0.000 description 1
- 235000001727 glucose Nutrition 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
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- 238000005461 lubrication Methods 0.000 description 1
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- 235000021436 nutraceutical agent Nutrition 0.000 description 1
- 208000015380 nutritional deficiency disease Diseases 0.000 description 1
- 210000003300 oropharynx Anatomy 0.000 description 1
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Classifications
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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
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/03—Organic compounds
- A23L29/035—Organic compounds containing oxygen as heteroatom
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
- A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
- A23L29/25—Exudates, e.g. gum arabic, gum acacia, gum karaya or tragacanth
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
- A23L29/275—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of animal origin, e.g. chitin
- A23L29/281—Proteins, e.g. gelatin or collagen
- A23L29/284—Gelatin; Collagen
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- 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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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Abstract
The composition properties of the present invention are excellent, while keeping the stability of composition system, with ease for use, lubricity and better mouthfeel, correlated crowd is helped to carry out swallowing various edible or pharmaceutical products, improve the experience of its medication or feed, while the composition of the present invention does not interfere with the release and absorption of drug in vivo.
Description
Technical field
The present invention relates to help to people's oral ingestion drug of the dysphagia caused by a variety of causes or feed.Pass through
Using the composition of the present invention, the medication of this kind of crowd or the experience of feed can be improved, and the composition of the present invention is not
It can influence the release and absorption of drug in vivo.
Background technology
The Crack cause of dysphagia or aphetite disorder is different, caused by being often as a variety of different illnesss, example
Such as esophagus dysphagia and oropharynx dysphagia, caused by relevant the nervous system disease, including apoplexy, esophageal injury, henry
The court of a feudal ruler disease etc. and Other diseases, such as：Muscle-derived disease, metabolic disease, chorionitis, diabetes, structural disease, very
To be operation after caused by damage etc..Dysphagia can also be caused by psychological factor, such as in oral solid tablet drug
Generated anxiety can cause to need to swallow using multiple drinking-water, or be easier to be stuck, and then aggravate anxiety.In addition,
Cause dysphagia may also be caused by the non-disease reason by body itself, such as function of deglutition is degenerated, this often occurs
In elderly population.
Dysphagia or aphetite disorder itself are not necessarily carried out diagnosing and treating as a kind of disease, unless being related to
Other serious diseases, and dysphagia or aphetite disorder itself can also due to non-disease it is caused,
Therefore, the dysphagia or aphetite disorder in the present invention, refers to dysphagia caused by any possible cause, or swallow not
It can comprising but the various solid articles of oral ingestion are not limited to, or carry out conventional diet, including various solid-states, semisolid
Deng food and special nutraceutical etc..
For the crowd for having dysphagia, such as：The elderly and children are needing to take solid pharmaceutical preparation
When, since to taking these solid pharmaceutical preparations (tablet, capsule etc.), there are bad sense learning through practice, it will usually tablet is destroyed, point
It takes several times, or the drug taking-up in capsule is individually taken several times.Although this method improves swallower itself
Experience and more easily drug administration, but it also destroys the dosage form of these drugs, affect the absorption of drug in vivo and
Drug effect.Also, it would generally assist carrying out using water when taking, but some drugs or pharmaceutical preparation itself and not have
Lubricity, and the surface layer of water can be also swum in the oral cavity, further increase the dysphagia degree of correlated crowd.In addition, right
For the elderly of the dysphagia caused by a variety of causes, on the feed during, due to dysphagia can cause feed eat
Object is there are certain risk, and food of bulk itself is difficult to directly swallow, and excessively fragmentary and tiny morse is being chewed
It is also easy to cause danger by accidentally sucking tracheae in the process with swallowing, and during chewing, food equally will appear scattered
The case where being broken into fine grained chippings.Which results in these crowds to become smaller to the selectable range of food, is also easy to that feed body can be caused
Test variation, it is often more important that be susceptible to malnutrition.
For the above situation, occur a variety of different solutions in the prior art, such as：Use the agent such as oral disintegrating tablet
Type so that drug directly absorbs in oral cavity, avoids the process of swallowing, or carry out by using modes such as liquid preparations.But
It is that these methods are not to be all suitable for all drugs, and there is also preservation or operational problems.Another is solved
Scheme is to carry out assisting deglutition by gel of the offer with greasy property or relevant composition, still, it is still desirable to
The superior composition of effect or the individual product of these compositions are provided, ease for use, the extension to improve them use
Range.Such as：Need that there is higher stability, more flexible mode of operation, better lubricant effect, being easy to get and cheap group
Raw material is closed, can be simultaneously used in food or drug, and absorption and the release etc. for not influencing drug.
Invention content
In order to overcome the problems of the prior art, the composition product with better performance is obtained, combination object is improved
The stability of system, ease for use, lubricity and mouthfeel preferably help correlated crowd to carry out swallowing various edible or pharmaceutical products, hair
A person of good sense provides the following technical solution after widely study.
The present invention provides a kind of compositions comprising following ingredient：The material of gel, plasticizer, carbon aquation can be formed
Close object and water.
Preferably, the composition further includes following auxiliary material：One of essence, pigment or a combination thereof.
Preferably, in the composition formed gel material can be one of gelatin, Arabic gum, carrageenan or
A combination thereof.
Preferably, the plasticizer in the composition is glycerine.
Preferably, the carbohydrate in the composition be glucose, corn syrup, malt syrup, fructose, starch it
One or a combination thereof.
Preferably, the composition includes following ingredient：Gelatin, glycerine, Arabic gum, glucose, corn syrup and water.
Preferably, according to weight ratio in the composition, the parts by weight of each ingredient are as follows：20-50 parts of gelatin, glycerine
10-20 parts, 10-20 parts of Arabic gum, glucose is 5-50 parts, 5-30 parts of corn syrup, 10-20 parts of water.
Further include the group of 1-5 parts of essence or 1-2 parts pigment, or both it is furthermore preferred that according to weight ratio
It closes.
Preferably, elastic modulus G ' of the composition in 1Hz is in the range of 300-30000Pa, viscous modulus G "
Elastic modulus G ' in the range of 300-50000Pa, and in 10Hz is in the range of 1000-1000000Pa, sticky mould
G " is measured in the range of 3000-1000000Pa.
Preferably, elastic modulus G ' of the composition at 10-40 DEG C is in the range of 1000-90000Pa, sticky mould
G " is measured in the range of 200-80000Pa.
Preferably, the gel strength of the composition at 25 DEG C in 15-70g/cm2In the range of.
Preferably, the pH value of the composition is 4.0-7.5, and preferred pH value is between 4.5-6.5.
On the other hand, the present invention also provides the associated uses of above-mentioned composition, can help aphetite disorder or tired
Difficult people swallows or feeds.Preferably, the aphetite disorder or difficulty can be since disease, function of deglutition move back naturally
Caused by change or mental handicape.It is furthermore preferred that described swallow including drug administration.
Preferably, the outer surface of the drug is covered with the composition of the present invention, or the combination of the artificial embedded present invention
In object or there is the outermost layer of the drug present composition to be formed by coating.
Preferably, it is more favorable that composition of the invention, which carries out swallowing after being mixed with food or food,.
It is furthermore preferred that described being mixed into is pulverized or is crushed.
On the other hand, the present invention also provides a kind of oral drug preparation, the pharmaceutical preparation active constituents of medicine most
There is outer layer smooth structure, the smooth structure to be made of the above-mentioned composition of the present invention.
Preferably, active constituents of medicine therein is active constituents of medicine itself, can also be the drug agent containing auxiliary material
Type or composition.Wherein pharmaceutical dosage form can be the various solid pharmaceutical preparations such as granule, tablet, capsule, pill, powder,
Preferred dosage form is：Granule, powder, tablet.
On the other hand, the present invention also provides a kind of food, it is characterised in that by the present invention composition and food or
Nutriment is mixed to get.
Composition in the present invention has viscoelastic property appropriate, therefore has excellent greasy property, can be held
Easy swallows, and does not need water or it is only necessary to a small amount of water to help to swallow.It largely studies and tests by inventor, send out
When now especially the elastic modulus G ' of the composition and viscous modulus G " are in specific numberical range, composition obtains properly
Viscoplasticity so that composition can preferably form uniform outer layer membrane structure, be conducive to the equal of the solid matters such as drug
Even covering, and be also easier to drug etc. being embedded in composition, and composition itself can cover the order of drug simultaneously
The offending smell of people.Meanwhile gel strength appropriate also ensures composition during for assisting deglutition, has more
Good mouthfeel, is unlikely to really up to the mark or excessively soft.Simultaneously after being mixed with food, food is enabled to form appropriate piece of size
Shape avoids to form excessively fragmentary tiny food particle, prevents the people of dysphagia from accidentally being sucked gas in the process on the feed
The possibility of pipe, and blocky and viscosity appropriate also ensures the greasy property for the mixture to be formed, therefore also can be by more
Readily swallows or feed.
Inventor has found in the course of the study, in order to be conducive to swallow, while needing that composition is kept to have appropriate glue
Property, offending feeling is swallowed and generates without will produce the obstruction such as stick to one's teeth, the composition as gel rubber system needs to have suitable
When viscosity, elasticity, and suitable gel strength range.Therefore, composition needs at a proper temperature, and suitable
There is certain viscosity and elasticity under shear rate.Inventor has found that the elasticity modulus when composition is at 10-40 DEG C exists
In the range of 1000-90000Pa, viscous modulus is in the range of 200-80000Pa.Or springform of the composition in 1Hz
G ' is measured in the range of 300-30000Pa, viscous modulus G " is in the range of 300-50000Pa, and the elasticity in 10Hz
For modulus G ' in the range of 1000-1000000Pa, viscous modulus G " is in the range of 3000-1000000Pa.The composition body
It is that there is suitable viscoplasticity and good smoothness and mouthfeel.
Meanwhile the gel strength of composition is maintained at 15-70g/cm at 25 DEG C2In the range of, it is ensured that it obtains
Composition is unlikely to really up to the mark and excessively soft, while being conducive to swallow, also ensure with food can carry out it is good mix, carry
The effect that height is swallowed.
In addition, the composition of the present invention also has excellent stability, when can be long under different environment, temperature condition
Between store so that it can be used as individual product to sell, and use when needed.It can also be used as the external coating packet of drug
Clothing is directly coated active constituents of medicine, forms pharmaceutical preparation and uses, while playing prevents active constituent therein from becoming
Matter.In addition, the present invention composition in vivo in have good dissolubility, can fater disintegration without influence drug or
The absorption of food etc..
Specific implementation mode
Material proportion in following embodiment is weight ratio.
Embodiment 1：
Gelatin and Arabic gum are added in suitable water, by heat to mixed dissolution at 80 DEG C, stirred evenly.It is added appropriate
Water so that glucose and corn syrup is dissolved, be slowly added to glycerine under stirring, obtained mixture be added to above-mentioned
In aqueous solution, at a temperature of maintaining 80 DEG C, after futher stirring uniformly, decompression water removal operation is carried out to system, it is extra to remove
After moisture, cool down, it is cooling.
Embodiment 2：
The preparation method is the same as that of Example 1, except that the temperature of heating and evaporation is 85 DEG C.
Embodiment 3：
The preparation method is the same as that of Example 1, except that the temperature of heating and evaporation is 90 DEG C.
Embodiment 4：
The preparation method is the same as that of Example 1, except that the temperature of heating and evaporation is 95 DEG C.
Embodiment 5：
The preparation method is the same as that of Example 1, except that the temperature of heating and evaporation is 70 DEG C.
Embodiment 6：
The preparation method is the same as that of Example 1, except that the temperature of heating and evaporation is 75 DEG C.
Embodiment 7：
The preparation method is the same as that of Example 1, the difference is that being only in that in the mixed solution that essence is eventually adding, so
It is stirred again afterwards, and the operation that decompression removes water.
Embodiment 8：
Preparation method the difference is that after being only in that addition essence, continues under stirring with embodiment 7, pigment is added,
Then stir evenly and carry out the operation of decompression water removal.
Embodiment 9：Estimation of stability
With reference to the method and principle tested preparation stability in Chinese Pharmacopoeia 2015 editions, embodiment 1-8 is prepared
Composition carry out accelerated test, to evaluate the stability of composition system.The operating condition of accelerated test is temperature 40 DEG C ± 2
DEG C and relative humidity be 75%RH ± 5%RH, by sample place 6 months, take 0,1,2,3,6 month time point respectively, into
Row detection and analysis, experimental result are as follows：0,1,2,3,6 month time point, the composition sample of observation embodiment 1-8,
Appearance, color do not change, and the phenomenon that crystallization does not occur in the stable system of composition.Meanwhile by detection combination object at
Point, it is also rotten without finding there is a situation where.
Embodiment 10：The measurement of composition system parameter
Instrument：The advanced rheometer of Physica MCR301 types, TA-XT2 plus type property testers.Test method, elasticity
Modulus, viscous modulus and gel strength carry out the selection of test condition all in accordance with instrument operation instructions, and according to this field
Routine techniques knowledge carry out parameter measurement.The gel strength of the composition sample of embodiment 1-8 is determined by experiment 25
DEG C when in 20-60g/cm2In the range of.
Elasticity modulus of the sample of embodiment 1-8 at 10-40 DEG C is between 3000-90000Pa, and loss modulus is in 500-
Between 70000Pa.
Embodiment 11：Disintegrating property is tested
Disintegrating property is tested：
Instrument：Disintegration time mensuration instrument, model LB-2D types.Test method, using disintegration time mensuration instrument at 37 DEG C,
The measurement for carrying out disintegration time limited in 0.1mol/L hydrochloric acid solutions, the phosphate buffer solution that pH is 6.8 respectively, measures composition
Disintegration time limited the results are shown in Table 1.
Table 1
Disintegration test the result shows that, composition of the invention can be disintegrated rapidly in vivo, do not interfere with pharmaceutical activity at
Divide absorption in vivo.
Embodiment 12：Swallow measure of merit
In order to actually investigate the assisting deglutition effect of the present composition, choosing 10 people of normal subjects and swallow
Difficult 10 people of subject provides specific experience evaluation result by the way of carrying out oral ingestion.Grading is from A-C, respectively
It is that A feels apparent for lubricant effect, it can direct oral ingestion.B is that lubricant effect feels general, can be swallowed.C is that lubrication is imitated
Fruit is bad, cannot directly swallow or have sense of discomfort.In order to simulate the size of actual solid drugs or preparation, rule are used
The blank chip (diameter units mm) that lattice are 9 and 13, is embedded into embodiment 2, in the composition of 7-8, surface is made to form one
Swallow test is carried out after layer coating membrane, test evaluation result is as follows：
Normal tested group, when swallowing the composition using 9mm and 13mm chips, all gives the result of grading A.
And dysphagia group is when swallowing the composition using 9mm chips, all gives grading A's as a result, swallowing 13mm cores
When the composition of piece, 90% give grading A's as a result, 10% give grading B result.Two groups do not provide grading C
Result.
As can be seen that the composition of the present invention has excellent smooth effect in actual assisting deglutition, it is easy to gulp down
Pharynx is without causing apparent sense of discomfort.
In order to verify actual effect of the present composition in terms of assisting deglutition food, select with dysphagia by
Examination person swallows the food for being mixed with the present composition, evaluates its result.Specific method is, by the group of embodiment 1-8
It closes object 20g and steamed small rice or Coarse cereals rice 200g is stirred mixing.As staple food, nutrition is rich for small rice or Coarse cereals rice
Richness is rich in multiple nutritional components, and having reduces the plurality of health care functions such as blood fat, is suitble to designed for old people.But due to this food
Object belongs to coarse food grain, and mouthfeel is thicker, and be easy it is fragmentary, therefore, either have for the elderly aphetite disorder or difficulty people and
Speech is not easy to carry out by chew and swallow.After being mixed with the composition of the present invention, it is provided with certain lubricity, can be formed
Small agglomerate and it is not easy fragmentary.The evaluation that subject provides is：Good mouthfeel there is no rough sense and is easy feed.
In addition, the present invention composition can also with other food, such as：Veterinary antibiotics, steamed bun, meat products etc. are various
The mixture of solid food or these foods the suitable hybrid mode such as is stirred mixing, pulverizes, is pulverized and mixed, to make
Standby easy-to-swallow food.The composition of the present invention can also be gulped down with various solid nutriment mixed edibles to improve to have
Swallow the nutrition condition of obstacle crowd.
To those skilled in the art, the embodiment of the present invention is only the preferred embodiments of the invention, in conjunction with
Specification disclosure, those skilled in the art can be changed and combined accordingly to it, in these relevant technologies
Hold without departing from the purpose of the present invention and in the case of obtaining similar technique effect, should all be considered as belonging to
Present disclosure is fallen within the scope of protection of present invention.
Claims (21)
1. a kind of composition comprising following ingredient：The material of gel, plasticizer, carbohydrate and water can be formed.
2. composition described in claim 1, it is characterised in that further include following auxiliary material：One of essence, pigment or its group
It closes.
3. the composition described in claim 1-2, it is characterised in that：The material of the formation gel be gelatin, Arabic gum,
One of carrageenan or a combination thereof.
4. the composition described in claim 1-3, it is characterised in that：The plasticizer is glycerine.
5. the composition described in claim 1-4, it is characterised in that：The carbohydrate is glucose, corn syrup, wheat
One of bud syrup, fructose, starch or a combination thereof.
6. the composition described in claim 1-5, it is characterised in that：It includes following ingredient：Gelatin, glycerine, Arabic gum, Portugal
Grape sugar, corn syrup and water.
7. the composition described in claim 6, it is characterised in that further include following auxiliary material：One of essence, pigment or its group
It closes.
8. the composition described in claim 6, it is characterised in that：According to weight ratio, the parts by weight of each ingredient are as follows：Gelatin
20-50 parts, 10-20 parts of glycerine, 10-20 parts of Arabic gum, glucose is 5-50 parts, 5-30 parts of corn syrup, 10-20 parts of water.
9. composition according to any one of claims 8, it is characterised in that：Further include 1-5 parts of essence or 1-2 according to weight ratio
The combination of the pigment of part, or both.
10. the composition of claim 1-9, it is characterised in that：Elastic modulus G ' of the composition in 1Hz is in 300-
In the range of 30000Pa, viscous modulus G " is in the range of 300-50000Pa, and elastic modulus G ' in 10Hz exists
In the range of 1000-1000000Pa, viscous modulus G " is in the range of 3000-1000000Pa.
11. the composition of claim 1-10, it is characterised in that：The gel strength of the composition is at 25 DEG C in 15-70g/
cm2In the range of.
12. the purposes of the composition of claim 1-11, it is characterised in that help there is aphetite disorder or the people of difficulty to gulp down
Pharynx or feed.
13. the purposes of claim 12, it is characterised in that aphetite disorder or difficulty be due to disease, function of deglutition retrogression of nature,
Or caused by mental handicape.
14. the purposes of claim 13, it is characterised in that swallow including drug administration.
15. the purposes of claim 12-14, it is characterised in that the outer surface covering of drug or active constituent therein is had the right
It is required that either the drug or active constituent are embedded into the composition of claim 1-11 the composition of 1-11, Huo Zhesuo
Composition of the outermost layer with claim 1-11 for stating drug or active constituent is formed by coating.
16. the purposes of claim 12-15, wherein feeding methods are to mix the composition of claim 1-11 and food
After swallowed.
17. the purposes of claim 16, therein be mixed into is pulverized or is mixed after crushing.
18. a kind of oral drug preparation has smooth structure in the outermost layer of active constituents of medicine, the smooth structure is by weighing
Profit requires the composition of 1-11 to constitute.
19. the oral drug preparation of claim 18, it is characterised in that active constituents of medicine can be drug ingedient itself, also may be used
To be pharmaceutical dosage form or composition containing auxiliary material.
20. the oral drug preparation of claim 18-19, wherein pharmaceutical dosage form can be granule, tablet, capsule, pill,
Powder, preferably granule, powder, tablet.
21. a kind of food, it is characterised in that be mixed to get by the composition and food or nutriment of claim 1-11.
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| CN201810308505.2A CN108578704A (en) | 2018-04-09 | 2018-04-09 | A kind of composition and its associated uses for swallowing |
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| CN201810308505.2A CN108578704A (en) | 2018-04-09 | 2018-04-09 | A kind of composition and its associated uses for swallowing |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112998258A (en) * | 2021-04-06 | 2021-06-22 | 北京中医药大学 | Food combination group, preparation method and application |
| CN113332364A (en) * | 2021-06-07 | 2021-09-03 | 南京厚生药业有限公司 | Granular medicine for supplementing nutrition and preparation method thereof |
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| CN101146457A (en) * | 2004-09-30 | 2008-03-19 | 好时公司 | Sealed, edible film strip packets and methods of making and using them |
| CN101938992A (en) * | 2008-02-06 | 2011-01-05 | 东英吉利大学 | Composition and method for assisting swallowing |
| CN102292077A (en) * | 2009-01-20 | 2011-12-21 | 迈德涂料公司 | A new coating composition and use thereof |
| CN107625742A (en) * | 2016-07-19 | 2018-01-26 | 北京科信必成医药科技发展有限公司 | One kind is anhydrous to swallow taste masking preparation and preparation method thereof |
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| US20030059614A1 (en) * | 1989-09-20 | 2003-03-27 | Hani Sadek | Enrobed core medicament |
| CN101146457A (en) * | 2004-09-30 | 2008-03-19 | 好时公司 | Sealed, edible film strip packets and methods of making and using them |
| CN101938992A (en) * | 2008-02-06 | 2011-01-05 | 东英吉利大学 | Composition and method for assisting swallowing |
| CN102292077A (en) * | 2009-01-20 | 2011-12-21 | 迈德涂料公司 | A new coating composition and use thereof |
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| CN112998258A (en) * | 2021-04-06 | 2021-06-22 | 北京中医药大学 | Food combination group, preparation method and application |
| CN112998258B (en) * | 2021-04-06 | 2022-05-10 | 北京中医药大学 | Food combination group, preparation method and application |
| CN113332364A (en) * | 2021-06-07 | 2021-09-03 | 南京厚生药业有限公司 | Granular medicine for supplementing nutrition and preparation method thereof |
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