CN106176690B - Hyaluronic acid oral care film and preparation method and application - Google Patents
Hyaluronic acid oral care film and preparation method and application Download PDFInfo
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- CN106176690B CN106176690B CN201610755307.1A CN201610755307A CN106176690B CN 106176690 B CN106176690 B CN 106176690B CN 201610755307 A CN201610755307 A CN 201610755307A CN 106176690 B CN106176690 B CN 106176690B
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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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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Abstract
The present invention relates to hyaluronic acid product technique field, in particular to a kind of hyaluronic acid oral care film contains the ingredient of following weight percentage: Sodium Hyaluronate 10%-50%, zinc hyaluronate 10%-40% in dry film, hydrolyzes Sodium Hyaluronate 10%-40%.Using hyaluronic acid and its derivative as the filmogen of oral cavity film, the mechanical performance of film is significantly improved, enhances flexibility；Using hyaluronic acid and its derivative as the main active of oral cavity film, there are multiple biological activities, and hyaluronic acid has the function of sustained release for other active constituents of addition, promotes absorption, synergistic；Zinc hyaluronate has stronger antibacterial and antiinflammation in addition to the bioactivity with Sodium Hyaluronate, is more conducive to health of mouth cavity daily, mouth disease prophylactic treatment and bottleneck throat nursing；Product of the present invention is slim and graceful, small in size, carrying and convenient transportation.
Description
Technical field
The present invention relates to hyaluronic acid product technique field, in particular to a kind of hyaluronic acid oral care film further relates to
The preparation method and application of hyaluronic acid oral care film.
Background technique
Pelliculae pro cavo oris is drug and the processed manufactured film-like preparation of suitable filmogen, is used for oral or mucous membrane.
Usually it is made of water soluble film-forming material, plasticizer, disintegrating agent, filler, corrigent, drug etc..Filmogen is dissolving films
The maximum auxiliary material of accounting weight, can account for 45% or more of film dry weight, wherein hydroxypropyl methylcellulose in prescription, amylopectin and
Gelatin is most common filmogen.Other common filmogens are there are also polycarbophil, cellulose derivative, and Propiram is more
Sugar, xanthan gum, sodium alginate, chitosan, Pluronic F-127, polyvinyl alcohol etc..Different filmogens can significantly affect film
Mechanical property and use feeling.
Hyaluronic acid is to constitute one of extracellular matrix and the main component of cytoplasm, is the natural component of human body, tool
There are brilliant moisture retention, lubricity, viscoelasticity, and there are multiple biological activities, is widely used to cosmetics, health care product and doctor
Medicine field.
Both at home and abroad multiple studies have shown that hyaluronic acid is the important component for constituting periodontal tissue's epimatrix in the oral cavity,
Also contain hyaluronic acid in the saliva of people, can be improved the greasy property and mouth disease healing performance of saliva, and assists to protect
Oral mucosa.Pirnazar's et al. research shows that hyaluronic acid (is acknowledged as and tooth intraoral actinobacillus actinomycetem comitans
All scorching closely related, be one of the bacterium of most study in periodontitis bacterial etiology), the general Salmonella of mouth, staphylococcus aureus
Deng there is an inhibiting effect, and the fungistatic effect of different molecular weight hyaluronic acid is different.Therefore, in saliva hyaluronic acid contents change
Whether different with oral cavity bacterium quantity and have gingivitis or periodontosis related.
The Effect of Oral Nursing Care of hyaluronic acid is shown as, the anti-inflammatory, anti-infective of the surface of a wound, water resistant after extraction and implant operation
Swollen, inhibition bacterial growth effect；Promote the effect of periodontium wound healing, reparation；Accelerate the healing of the disease of cari oris mucosa
Journey relieves pain；It solves due to xerostomia and the scorching hot bring discomfort of mucous membrane etc..In addition, hyaluronic acid is also widely used in toothpaste
In product.
Zinc ion has apparent anti-inflammatory and antibacterial action, while can accelerate epithelium regeneration speed, reduces inflammatory reaction.Thoroughly
Bright matter acid zinc is obtained by Sodium Hyaluronate by zinc ion displacement reaction.Zinc hyaluronate is in terms of bioactivity, in addition to having
Outside the effect of Sodium Hyaluronate, also has the function of zinc ion, therefore there are stronger antibacterial and anti-inflammatory effects, can be used for assisting
Treat bacterium and fungal infection.
It is related to the oral care product of hyaluronic acid, predominantly liquid dosage form.103405470 A of CN discloses a kind of molten
The hyaluronic acid compositions of liquor type, for treating and alleviating xerostomia.105056219 A of CN discloses one kind and contains
The artificial saliva of 0.5mg/ml hyaluronic acid.103462847 A of CN discloses a kind of oral care mouthwash.
103211801 A of patent CN discloses rapidly-soluble film in a kind of oral cavity, by water soluble film-forming material
30%-90%, plasticizer 2%-20%, disintegrating agent 0%-5% and active pharmaceutical ingredient 0.1%-70% composition.Used film forming
Material is the mixture of hypromellose and hyaluronic acid, and weight proportion is 20~80:1, and hyaluronic acid dosage is extremely low, no
Foot 5%.
But that the above-mentioned hyalomitome acids product recorded in the prior art uses is common Sodium Hyaluronate, Er Qietian
Dosage is relatively low, and needing to be added other active components just has antibacterial, health care and other effects, to oral cavity cellular damage reparation, also needs
Cell repair agent is additionally added, its popularization and use is limited.
Summary of the invention
It has a single function, be unfavorable for solve the above acids of the hyalomitome in the prior art product present in the oral health
The problem of popularization, this application provides a kind of hyaluronic acid oral care films with antibacterial, repair cell damage and other effects.It should
The characteristics of film is with hyaluronic acid and its derivative for whole filmogens, while being also main active constituent, plays oral cavity
It is antibacterial, anti-inflammatory, repair, moisturizing the effects of, assign film oral cavity and the effect of bottleneck throat daily health caring, Prevention disease.Root
According to needs, also contain wetting agent, other active constituents.It is divided into oral cavity or tooth film according to application method and purposes and oral cavity is molten
Film.
The present invention also provides the preparation methods of the hyaluronic acid oral care film.
What the present invention was obtained through the following steps:
A kind of hyaluronic acid oral care film contains the ingredient of following weight percentage in dry film:
Sodium Hyaluronate 10%-50%, zinc hyaluronate 10%-40% hydrolyze Sodium Hyaluronate 10%-40%.
The hyaluronic acid oral care film contains the ingredient of following weight percentage in dry film:
Sodium Hyaluronate 10%-30%, zinc hyaluronate 10%-20% hydrolyze Sodium Hyaluronate 20%-30%.
The hyaluronic acid oral care film contains the ingredient of following weight percentage in dry film:
Sodium Hyaluronate 10%-20% or 20%-30%, zinc hyaluronate 10%-15% or 15%-20%, hydrolysis are saturating
Bright matter acid sodium 20%-25% or 25%-30%.
The hyaluronic acid oral care film, also contains wetting agent: 1%-30%, other activity in addition to hyaluronic acid
Ingredient: 0-20%.
Hydrolysis hyaluronic acid or its salt in the present invention are Hua Xi Fu Ruida biomedical company's independent research and produce
Product, the bacillus hyaluronidase obtained with bacillus A50CGMCC NO.5744 fermented and cultured to hyaluronic acid or its
The digestion oligomerization hyaluronic acid or its salt that salt is degraded.Degradation condition is mild, easy to operate, non-environmental-pollution, and
Obtained product structure is complete, and bioactivity is higher, and molecular weight is 2~20kDa, preferably 8kDa.
The molecular weight of the hyaluronic acid oral care film, Sodium Hyaluronate and zinc hyaluronate be 100~
2000kDa, preferably 800kDa.
Different oral care ingredients can be added in the oral care film as needed, to assign film different oral cavities
Effect is nursed, active component includes flavorants, antiplaque agent, antibacterial agent, periodontal active, desensitizer, analgesic, saliva
Stimulant, brightener for tooth, caries preventive agent, calculus dentalis controlling agent, nutritional agents etc., and combinations thereof.
The hyaluronic acid oral care film, active constituent are grape seed extract, tea polyphenols, vitamin B2, lemon
One or more of acid, sodium citrate, xylitol and menthol.
The hyaluronic acid oral care film, the wetting agent are one or more of glycerol, propylene glycol, butanediol.
The preparation method of the hyaluronic acid oral care film, Sodium Hyaluronate, zinc hyaluronate and hydrolysis is transparent
Matter acid sodium is added to the water, and 60~65 DEG C are heated under stirring condition, continue stirring dissolve it sufficiently, then, be added remaining at
Point, it after stirring and dissolving mixes, is coated on stainless steel plate, thickness 0.01-2mm, forms a film in 45~50 DEG C of low temperature dryings, control is dry
Residual moisture is 5%-15% in film.
The purposes of oral cavity film of the present invention is health of mouth cavity daily, mouth disease prevention and treatment, including breath freshening, mouth
It is smelly prevention or mitigation, dry prevention or mitigate, oral mucosa lesion healing, dental plaque prevention or mitigate, periodontitis and gingivitis it is pre-
Anti- or mitigation, dental whitening, dental calculus control, hemodia prevention or mitigation etc..In addition there are bottleneck throat nursing, such as pharyngitis.
It is divided into the molten film of oral cavity or tooth film and oral cavity according to application method and purposes.
Hyaluronic acid or salt have the effects that inhibit oral bacteria, anti-inflammatory, mucosa injury reparation, moisturizing.It is embodied in,
The anti-inflammatory, anti-infective of the surface of a wound, antioedematous, inhibition bacterial growth effect after extraction and implant operation；Promote periodontium wound healing
The effect closed, repaired；The healing process for accelerating the disease of cari oris mucosa, relieves pain；It solves due to xerostomia and the scorching hot band of mucous membrane
The discomfort etc. come.In terms of alleviating xerostomia, hyaluronic acid has been considered as replacing mouth as a kind of important moisturizer
The candidate substances of the dry patient's saliva of chamber.The hydrolysis micromolecule hyaluronic acid or its salt that molecular weight is 2~50kDa have more significant
Reparation, it is anti-inflammatory, remove the bioactivity such as free radical.
Beneficial effects of the present invention:
(1) using hyaluronic acid and its derivative as the filmogen of oral cavity film, the mechanical performance of film is significantly improved, is enhanced
Flexibility, it is non-breakable；
(2) using hyaluronic acid and its derivative as the main component of oral cavity film, there is multiple biological activities, and hyalomitome
Acid has the function of sustained release for other active constituents of addition, promotes absorption, synergistic；
(3) zinc salt of hyaluronic acid is in addition to the physiology bioactivity with hyaluroni, have it is stronger antibacterial and
Antiinflammation is more conducive to the mitigation of the symptoms such as the disease of cari oris mucosa, gingivitis, plaque, hemodia；
(4) hyaluronic acid is also a kind of important health product raw material (for the new raw-food material of CFDA approval), has supplement
The beauty treatment health care efficacies such as moisture of skin, anti-oxidant, significantly improve dry skin, keep skin smooth moist；Also there is joint care
Effect improves function of joint, mitigates arthritis, improves joint lubrication ability, mitigates arthralgia.Product of the present invention is except performance
Outside oral care health-care effect, whole body health-care effect can be also played after oral absorption；
(5) filmogens such as cellulose family, polyethylene glycol or polyethylene oxide, starch are compared, hyaluronic acid is in human body
Bio-molecules, exist in saliva and periodontal tissue's epimatrix, safety is higher；
(6) oral care product of the dosage forms such as solution, spraying, gel, need to be added during storage preservative to prevent
Only microbial contamination.And pelliculae pro cavo oris is not necessarily to preservative since moisture content is extremely low, improves safety in utilization；
(7) product of the present invention is slim and graceful, small in size, carrying and convenient transportation.
Detailed description of the invention
Repair figure of each embodiment nursing film of Fig. 1 to damaging cells.
Specific embodiment
Invention is further explained combined with specific embodiments below:
1. Example formulations form
Note: numerical value is each component weight percent shared in dry film in table.
2. the preparation process of embodiment:
Each embodiment prepares 100g solution respectively.First by Sodium Hyaluronate and (or) zinc hyaluronate, and hydrolysis hyalomitome
Sour sodium is added in the water of corresponding amount, and 60~65 DEG C are heated under stirring condition, and continuing stirring dissolves it sufficiently.Then, it is added
Remaining ingredient is coated on stainless steel plate, thickness 0.3mm after stirring and dissolving mixes, in 45~50 DEG C of low temperature drying film forming (controls
In dry film processed 9%) residual moisture is.
3. the measuring mechanical property of film
Method: using universal testing machine, carries out extension test to each embodiment sample, and film width is cut to 2.0cm,
Fixture spacing is 3.0cm, tensile speed 5mm/min, carries out longitudinal stretching to membrane material, until film is broken, reads from instrument
The tensile strength of film, and calculate extension percentage.
Folding strength test, by same tester, by the doubling repeatedly of each sample diaphragm, until there is crack in film surface, it should
Folds are its folding strength.
As a result: test result is shown in Table 1.Test result shows that the parameters of embodiment 9 are significantly better than other each groups,
Tensile strength performance is most obvious, shows Sodium Hyaluronate, zinc hyaluronate and the machine for hydrolyzing Sodium Hyaluronate three compound tense film
Tool performance is best.
The measuring mechanical property result of 1 film of table
| Tensile strength (MPa) | Extend percentage (%) | Folding strength (secondary) | |
| Embodiment 1 | 63.15 | 3.9 | 21 |
| Embodiment 2 | 79.77 | 4.3 | 31 |
| Embodiment 3 | 86.43 | 4.7 | 36 |
| Embodiment 4 | 83.15 | 4.5 | 32 |
| Embodiment 5 | 87.48 | 4.7 | 32 |
| Embodiment 6 | 77.65 | 4.3 | 30 |
| Embodiment 7 | 80.82 | 4.4 | 32 |
| Embodiment 8 | 82.11 | 4.4 | 31 |
| Embodiment 9 | 91.26 | 5.6 | 39 |
| Embodiment 10 | 86.71 | 4.7 | 38 |
| Embodiment 11 | 89.35 | 4.9 | 44 |
| Embodiment 12 | 90.63 | 5.1 | 42 |
| Embodiment 13 | 74.23 | 4.2 | 21 |
| Embodiment 14 | 66.16 | 4.0 | 20 |
| Embodiment 15 | 45.6 | 3.0 | 24 |
4. the bacteriostatic activity of film
Bacterial strain: porphyromonas gingivalis (ATCC 33277), actinobacillus actinomycetem comitans (ATCC 29523), intermediate Prey are fertile
Bacterium (ATCC 25611).
Bacteria inhibition tablet preparation: an equal amount of each embodiment oral cavity film of 3cm × 3cm is taken to be dissolved in 10mL sterile distilled water.
Sterile and dry 5mm diameter filter paper is taken, every 20 μ L of dropwise addition coating solution is spare after dry.
Test organisms inoculation, culture: being inoculated with using conventional method, and strain density is 1 × 106cfu/mL.Bacteria inhibition tablet is placed with
Microbiological contamination plate, after cultivating 48h, with vernier caliper measurement inhibition zone size.
As a result: bacteriostatic activity the results are shown in Table 2.The result shows that the fungistatic effect of embodiment 8,9,10,11,12 is stronger, secondly
It is embodiment 2,3,4,6,7.
The bacteriostatic activity test result (antibacterial circle diameter, mm) of 2 film of table
| Porphyromonas gingivalis | Actinobacillus actinomycetem comitans | Intermediate Prey irrigates bacterium | |
| Embodiment 1 | 5 | 5 | 5 |
| Embodiment 2 | 7 | 7 | 7 |
| Embodiment 3 | 8 | 7 | 7 |
| Embodiment 4 | 7 | 6 | 6 |
| Embodiment 5 | 5 | 4 | 4 |
| Embodiment 6 | 8 | 8 | 8 |
| Embodiment 7 | 9 | 9 | 9 |
| Embodiment 8 | 11 | 10 | 9 |
| Embodiment 9 | 12 | 11 | 11 |
| Embodiment 10 | 12 | 12 | 12 |
| Embodiment 11 | 11 | 11 | 11 |
| Embodiment 12 | 11 | 10 | 10 |
| Embodiment 13 | 2 | 2 | 2 |
| Embodiment 14 | 5 | 4 | 4 |
| Embodiment 15 | 3 | 3 | 3 |
5. the cellular damage repairing activity of film
1) prepared by test sample: each embodiment sample being cut into 3cm × 3cm size, uses the phosphoric acid buffer of 10mL respectively
Liquid (pH 7.2) dissolution, filtration sterilization, as test sample.
2) bed board: the Gingival Fibroblasts (HGF-1 cell) in logarithmic growth phase are taken, according to 5 × 105/ mL's is thin
Born of the same parents' density is inoculated in 96 porocyte culture plates, and every 100 μ L cell suspension of hole sets 37 DEG C of carbon dioxide incubator, 5%CO2It is conventional
Overnight incubation.
3) modeling: 7.2J/cm is used2UVA adds 126mJ/cm2UVB irradiates fibroblast cell, if irradiation experimental group (is shone
Embodiment sample solution is added after penetrating), irradiation control group and Normal group (no irradiation).After irradiating experimental group irradiation, discard
The different embodiment sample solution of 100 μ L is added in culture solution, and the culture medium of equivalent is added in irradiation control group and Normal group,
It is put into and continues to cultivate in incubator.After continuing culture for 24 hours, 10 μ L MTT are added in every hole, are put into and are continued to be incubated in cell incubator
4h.Culture solution is discarded, 100 μ L DMSO are added in every hole, are protected from light concussion 10min, are inhaled at 490nm wavelength with microplate reader measurement light
Receipts value.
4) cell proliferation rate (RGR) is calculated:
In formula, AcFor sample absorbance, AC, 0For Normal group absorbance.
As a result: the cell proliferation rate highest that 9,10,11,12 groups of embodiment shows that the repair to damaging cells is most strong；
Followed by 2,3,4 groups of embodiment and 6,7,8 groups of embodiment.
The above embodiment is a preferred embodiment of the present invention, but embodiments of the present invention are not by the limit of embodiment
System, other any changes made without departing from the spirit and principles of the present invention, modification, combination, substitution, simplification should be
Equivalence replacement mode, is included within the scope of the present invention.
Claims (9)
1. a kind of hyaluronic acid oral care film, it is characterised in that contain the ingredient of following weight percentage in dry film:
Sodium Hyaluronate 10%-50%, zinc hyaluronate 10%-40% hydrolyze Sodium Hyaluronate 10%-40%；
The molecular weight of the hydrolysis Sodium Hyaluronate is 2~20 kDa；
The molecular weight of the Sodium Hyaluronate and zinc hyaluronate is respectively 100~2000kDa.
2. hyaluronic acid oral care film according to claim 1, it is characterised in that contain following weight percent in dry film
The ingredient of content:
Sodium Hyaluronate 10%-30%, zinc hyaluronate 10%-20% hydrolyze Sodium Hyaluronate 20%-30%.
3. hyaluronic acid oral care film according to claim 1, it is characterised in that contain following weight percent in dry film
The ingredient of content:
Sodium Hyaluronate 10%-20%, zinc hyaluronate 15%-20% hydrolyze Sodium Hyaluronate 25%-30%.
4. hyaluronic acid oral care film according to claim 1, it is characterised in that the hydrolysis Sodium Hyaluronate, for
The bacillus hyaluronidase that bacillus A50CGMCC NO.5744 fermented and cultured obtains carries out hyaluronic acid or its salt
The digestion oligomerization Sodium Hyaluronate that degradation obtains.
5. hyaluronic acid oral care film described in any one of -4 according to claim 1, it is characterised in that also contain wetting agent
With the other active components in addition to hyaluronic acid.
6. hyaluronic acid oral care film according to claim 5, it is characterised in that active constituent is flavorants, resists
Dental plaque agent, antibacterial agent, periodontal active, desensitizer, analgesic, saliva stimulant, brightener for tooth, caries preventive agent, calculus dentalis control
One or more of preparation and nutritional agents.
7. hyaluronic acid oral care film according to claim 5, it is characterised in that other activity in addition to hyaluronic acid
Ingredient is grape seed extract, tea polyphenols, vitamin B2, citric acid, sodium citrate, one of xylitol and menthol with
On, the wetting agent is one or more of glycerol, propylene glycol, butanediol.
8. a kind of preparation method of hyaluronic acid oral care film of any of claims 1-7, it is characterised in that will
Sodium Hyaluronate, zinc hyaluronate and hydrolysis Sodium Hyaluronate are added to the water, and 60~65 DEG C are heated under stirring condition, continues to stir
Mixing dissolves it sufficiently, then, remaining ingredient is added and is coated on stainless steel plate, thickness 0.01- after stirring and dissolving mixes
2mm forms a film in 45~50 DEG C of low temperature dryings, and controlling residual moisture in dry film is 5%-15%.
9. a kind of hyaluronic acid oral care film of any of claims 1-7 or claim 8 are prepared saturating
Bright matter acid oral care film prepare health of mouth cavity daily, mouth disease prevention and treatment articles and bottleneck throat nursing materials in
Using.
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