CN101119769A - Oral compositions for prevention and reduction of bacterial adhesion to oral surfaces - Google Patents
Oral compositions for prevention and reduction of bacterial adhesion to oral surfaces Download PDFInfo
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- CN101119769A CN101119769A CNA200580048166XA CN200580048166A CN101119769A CN 101119769 A CN101119769 A CN 101119769A CN A200580048166X A CNA200580048166X A CN A200580048166XA CN 200580048166 A CN200580048166 A CN 200580048166A CN 101119769 A CN101119769 A CN 101119769A
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- oral cavity
- antitack agent
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- antibacterial
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Abstract
The present invention encompasses an oral composition containing an anti-adhesion agent, preferably a cysteine protease and most preferably ficin. In another aspect, the cysteine protease is in combination with one or more ingredients, such as antibacterial agent and surfactant. The anti-adhesion agent mitigates interaction between a subject oral cavity and plaque-forming materials.
Description
The cross reference of related application
[0001] the U.S. Provisional Patent Application series number 60/636,788 of claimed 2004 Decembers of the application application on the 16th and 60/636,787 priority, its full content is attached to herein by reference.
Background of invention
[0002] dental plaque or dental plaque biomembrane are a kind of for example organizing in the oral cavity and soft deposit that dental surface forms, are made up of antibacterial, saliva and food by-product.Dental plaque is firm adheres to irregular or discontinuous place (for example invest tartar, be positioned at the gum line, tongue surface and teeth space crack etc.).Except not attractive in appearance, dental plaque is also relevant with the generation of gingivitis and other forms of periodontal disease.
[0003] major part is the biomembranous some of protectiveness in the oral cavity bacterium, makes its tolerance great majority treatment in essence.Even the antibacterial on the demonstration tongue reaches 50% of antibacterial in the oral cavity, tongue is cleaned in the back but few people brush teeth.For many people, because pharyngeal reflex, brush or wiping tongue are difficult in addition.Therefore, the cleaning tongue of on-mechanical is in demand for the people that can not clean with machinery.
[0004] advised in this area that the medicine of numerous species is to stop plaque formation and to prevent to form the relevant oral cavity infection and the generation of odontopathy with plaque.
[0005] though many prior arts relate to antibacterial dentifrice and composition for oral cavity, this area still needs to prepare a kind of product that can improve prevention plaque build-up effect.
The invention summary
[0006] the present invention includes a kind of antitack agent (anti-adhesion agent) that contains, preferably cysteine proteinase and the most preferably composition for oral cavity of ficin.On the other hand, for example antibacterial and surfactant coupling of cysteine proteinase and one or more compositions.Anti-adhesion agent mitigates oral surfaces and dental plaque form for example interaction between the antibacterial of material.
Detailed Description Of The Invention
[0007] the invention provides a kind of enzyme of particular type, be used for prevention, stop or suppress at least dental plaque form material comprise biological substance, chemical substance, microorganism and antibacterial in conjunction with, adhere to or be attached to oral surfaces.The enzyme that the present invention uses suppresses the generation of the bacterial layer of formation dental plaque.Be sure of that this kind of enzyme comprises that by attaching to oral surfaces thereby parenchima suppresses growth or its further growth of dental plaque.Term in the literary composition " antisticking " was used interchangeably with " anti-adhering to ".Used suitable enzyme comprises anti-adhesion protease among the present invention, preferred cysteine proteinase and most preferably be selected from the protease of ficin, caricin and Antarctic krill protease (krillase).Preferably, antitack agent comprises ficin and one or more other enzymes, for example for example bromelain, Chymotrypsin, alcalase, amylase (amalysecs), glucoseoxidase, cellulase (cellusases), lipase (lipsases) of the enzyme of other anti-adhesion enzyme or another type, and/or other protease except that the antisticking cysteine proteinase.
[0008] the used ficin of the present invention can be by any method preparation known in the art (Ficin for use in the invention may be obtained by any means fromthe.).Preferably obtain by dry also filtration of the milk that Ficus (Ficus) plant is comprised Ficus glabrata.
[0009] amount of the antitack agent that exists in the compositions depends on various application.The amount of its existence is by weight less than 100 parts in compositions or in the appropriate carriers.At least account for 0.01 part in the per by weight 100 parts of compositionss of the amount of required antitack agent.Generally speaking, count the basis with total composition weight by 100 parts, the amount of the anti-adhesion enzyme preparation that exists in per 100 parts is about 10 parts of about 0.01-by weight.More desirable is that it is at least 0.05 part, and preferably is suitable for 0.03-0.3 part of paste composition.
[0010] one or more other antiplaque agents can the effective total amount of anti-plaque exist.Suitable medicament includes but not limited to stannous salt, mantoquita, magnesium salt and strontium salt, and dimethicone copolyol (dimethicone copolyol) is for example citric acid, tartaric acid and alkali metal salt thereof of cetyl dimethicone copolyol, glucoamylase, glucoseoxidase, urea, calcium lactate, calcium glycerophosphate, polyacrylic acid strontium and chelating agen for example.
[0011] compositions can contain other additive and material, comprises activating agent or the enamel and/or the conventional oral care additives or the excipient of any needs.For example the antibacterial that can exist comprises Benzethonium Chloride, diisobutyl phenoxy ethoxy ethyl dime-thyl benzyl ammonium chloride and cetylpyridinium chloride and at the United States Patent (USP) the 5th of authorizing Gaffar etc., 776, the medicament of listing for No. 435, it is attached to herein by reference.
[0012] compositions of the present invention also can comprise grinding agent for example silicon dioxide or perlite, wetting agent is glycerol, sorbitol, xylitol and/or propylene glycol for example, thickening agent, surfactant, fluoride sources, synthetic anionic polycarboxylates, aromatic, antilithic (antitartar agents), coloring agent, desensitizer (for example potassium nitrate), brightening agent, antiseptic, silicone and chlorophyll compound.If there are these additives, the amount that joins in the composition for oral cavity will not damaged required character and feature substantially.
[0013] oral care composition of the present invention can be made by any usual manner.Technology of preparing needs to change according to required final delivery form, these forms can comprise any known oral care formulations, for example paste, gel, suspensoid, confection (chewing gum, confection, lozenge, lozenge), bar (tapes), thin film thing, cleaning and detergent, tablet.
[0014] for example can be prepared as follows paste: in conventional mixer, wetting agent (for example glycerol, sorbitol, propylene glycol and Polyethylene Glycol) is dispersed in the water under stirring.In dispersion, add enzyme or enzyme organic thickening agent (for example xanthan gum), any anionic polycarboxylates, any salt (for example sodium fluoride preventing decayed tooth medicament), tetrasodium pyrophosphate, the anti-tartar salt of sodium tripolyphosphate and any sweetener, stir the gained mixture until forming even gel phase.In gel phase, add pigment (TiO for example
2) and any required acid or alkali to regulate pH.Mix these compositions up to obtaining homogeneous phase.Then this mixture is transferred in the high speed/vacuum mixer, wherein in this mixture, adds inorganic silicon dioxide thickening agent and surfactant.At this moment add other grinding agent that uses in low oily silica abrasive that absorbs and the compositions.In about 20-50 millimetres of mercury vacuum, this mixture of mixed at high speed is 5-30 minute under preferred about 30 millimetress of mercury then.Products therefrom be uniformly, semi-solid, extrudable paste or jel product.
[0015] the invention provides and maintain and stabilize proteinase activity or make the minimized useful preparation of loss of activity at least.Favourable, the coupling and synergistic results based on antisticking and antiseptic is provided in preparation of antibacterial and protease.Present composition function comprises antisticking and dental plaque decomposition function.In one aspect, preferred ficin is used for the former and preferred caricin is used for the latter.In one aspect of the method, ficin and caricin all demonstrate and transmit the anti-adhesion mode of action that anti-plaque is renderd a service in people's clinical research, and ficin is renderd a service higher than caricin.The invention provides and have for the protease of oral plaque bacteria activity of anti-adhesion and be suitable for the compositions of dental care, it comprises the treatment carrier with other same stabilize proteins enzyme function.In a word, the protease (ficin) that preferably derives from Ficus carica L. is in simple solution, in liquid teeth cleaning agent and confirming to have activity of anti-adhesion in the paste fully.This compound exhibits goes out to be better than the single bacterial species of prevention of negative control and the effect that blended cultivation species adhere to polystyrene surface, hydroxyapatite surface and dermal tooth surface.This chemical compound further demonstrates and improves tooth sample surface by the surface energy that reduces this surface is the prismatical activity of germanium.This chemical compound can use separately or as mixture and other enzyme or antibacterial agents.Composition for oral cavity of the present invention can be used for the treatment of any experimenter that the oral cavity is arranged, and comprises biology, humans and animals, and the oral cavity comprises mouth, tongue, tissue, tooth, palate and enamel etc.This composition for oral cavity can by any method and be not limited to any specific method contact oral cavity and be applied in the oral cavity.Example comprise liquid-carrier for example mouthwass, paste vehicle for example toothpaste, dentifrice, suck pearl (mouth beads) and freshener, chewing gum, toy, chewable tablet, can apply (paint-on) compositions and gel, consumer goods, edible articles for use and confection.
Example I-the contain dentifrice formulation of anti-adhesion enzyme
[0016] enzyme is formulated in the silica base formulation.Table 1 provides the exemplary dentifrice such preparation.Except as otherwise noted, all values is weight percentage.Crucial prescription composition is for accounting for the enzyme of 0.226% ficin, caricin and Antarctic krill protease by weight in the preparation, account for 25% the mixed silica abrasive system that high-quality cleans that is used for by weight, account for the mixed surfactant system of poly alcohol (pluronic) and 1% the betanin of 0.5% SLS/1.5% in addition by weight separately.Be also included within enzyme and have stable Herba Menthae-Herba Menthae Rotundifoliae spice down.Selected respectively various components are used to give characteristic (for example foam, fragrance, mouthfeel and aesthetic requirement) and the activity of not damaging enzyme.For enzyme concentration, before selecting clinical preparation, be used for selecting the dose response research of enzyme effect level.Based in vitro study, in OPTC (dental care technique center (Oral ProcessTechnology Center)), making the clinical goods of using under the GMP condition.
Table 1: the dentifrice formulation that contains enzyme
| Composition | Ficin | Caricin | Antarctic krill protease |
| The spearmint 30% Cocoamidopropyl betaine sodium fluoro phosphate of 70% sorbierite, 99.5% synthetic glycerine-USP purified water tooth and artificial mixing natural with silica-Zeodent 165 29% NaLS Pa Luoshamu (Poloxomer) 407 CMC sodium salt 2000S-12USP of the synthetic noncrystalline precipitation of type silica (Zeodent 115) Macrogol 600s (PEG-12) NF No.2 with type silica (Sylodent XWA 650-USP) tooth-poly-OXWSR-N 750 Blue Poly 50 blue solution (Blue color solution) the ficin papain krillase of USP sodium pyrophosphate-Fine (FCC) saccharin sodium USP xanthans-NF | 24.374 20.0 17.0 17.0 8.000 3.000 2.500 0.5 1.500 1.200 1.100 1.000 0.760 0.500 0.500 0.400 0.100 0.300 0.040 0.226 0 0 | 24.374 20.0 17.0 17.0 8.000 3.000 2.500 0.5 1.500 1.200 1.100 1.000 0.760 0.500 0.500 0.400 0.100 0.300 0.040 0 0.226 0 | 24.374 20.0 17.0 17.0 8.000 3.000 2.500 0.5 1.500 1.200 1.100 1.000 0.760 0.500 0.500 0.400 0.100 0.300 0.040 0 0 0.226 |
| Total amount | 100 | 100 | 100 |
Example II: the anti-effect research-artificial mouth of adhering to
[0017] for checking the effectiveness of active substance in the formulation of tooth-paste, the hydroxyapatite of saliva coated (hydropxyapatite) (SHAP) disk is crossed system by the bacterial cultures that main bacteria in the human mouth is formed with the velocity flow consistent with saliva in the human body as artificial teeth.8 disks at every turn handling are then put in the chemostat flow cell, make oral bacteria culture flow through disk and spend the night (20-24 hour), thereby judge whether the active substance that is coated on disc surfaces stops biomembrane to form.Remove the SHAP disk after 24 hours and measure the amount of antibacterial.Measure the also ABS of analytical solution then
610Estimate attached to the amount of bacteria on the SHAP disk with this result.According to this value, estimate the percentage anti-adhesion effectiveness of this paste with respect to the negative control of coupling.To every kind of check two protease concentrations, i.e. 0.226% weight and 0.065% weight in these three kinds of protease.Artificial mouth anti-adhesion experiment shows that in to three kinds of protease under each two concentration of testing, on average, all effectiveness of three kinds are all greater than the negative control paste that does not contain any enzyme.But be based on statistical analysis, do not prove the effectiveness of Antarctic krill protease.Caricin and ficin demonstrate effectiveness under 0.226% concentration.Ficin shows similar effectiveness 0.065% with 0.226%.Based on these results, preparation is used to prove the GMP batch goods of preliminary clinical research.In vitro results shows that ficin is better than caricin, and caricin is better than the placebo paste of mating again.
EXAMPLE III: clinical evaluation in the body
[0018] carries out two kinds of people's clinical researches with the anti-adhesion effectiveness of test products with respect to the negative control paste of coupling.Hereinafter indicated with dental plaque and reduced the clinical procedure that the ultimate yield that is brought is passed judgment on anti-adhesion effectiveness.
A.
The gum edge dental plaque index of improvement is measured (MGMPI)-test products 0.226% Fructus Fici The negative control of protease and coupling
[0019]In this clinical research, raise and recruit 15 (15) (in-house) experimenters at home.Finish the research in this 3 week for 14 (14).An experimenter needs the slight disease of antibiotic therapy to exclude the research owing to suffering from.All personnel carries out examination of mouth and medical history examination to dental clinic.All acceptable experimenters accept prevention (tooth cleaning) and begin one-week cleaning with ColgateGreat Regular.At the treatment stage of clinical research, each experimenter reported to dental clinic in specified morning.They accept thorough toothwash and thereby all tartar and dental plaque are removed in prevention.During this step, use and show that liquid is to confirm thoroughly to have removed all dental plaques and tartar.The experimenter uses the specified dentifrice of 1.5gm then, brushes and cleans 5 seconds with 10ml water then in 60 seconds.Indicate the experimenter not carry out all oral hygienes in 24 hours then and handle, returned dental clinic in 24 hours when finishing with showing that liquid cleans and to its dental plaque marking.The experimenter used cleaning article to recover normal oral hygiene nursing (brushing whole oral cavity every day 2 times) after dental plaque marking was finished.The result shows below.
| Dental plaque score (MGMPI) | Enzyme toothpaste (0.226% ficin) | The placebo toothpaste of coupling |
| 24 hourly average scores | 14.55±8.50* | 30.38±17.99 |
* with placebo significance,statistical (p＜0.05) relatively
Use the t-check to determine the difference (p＜0.05) that exists between product.Enzyme dentifrice (0.226% ficin) is compared with the placebo of coupling has significant difference.Contain the demonstration of ficin dentifrice and reduced dental plaque clinically by anti-adhesion mode of action.
B.
The gum edge dental plaque index of improvement is measured (MGMPI)-test products 0.226% Fructus Caricae The negative control of protease and coupling
[0020]Except that recruiting 14 experimenters in this test and all finishing the research, clinical procedure is described identical with above-mentioned ficin.
| Dental plaque score (MGMPI) | Enzyme toothpaste (0.226% ficin) | The placebo toothpaste of coupling |
| 24 hourly average scores | 17.07±7.03* | 30.38±17.95 |
* with placebo significance,statistical (p＜0.05) relatively
Use the t-check to determine the difference (p＜0.05) that exists between product.Enzyme dentifrice (0.226% caricin) is compared with the placebo of coupling has significant difference.Contain the demonstration of caricin dentifrice and reduced dental plaque clinically by anti-adhesion mode of action.Relatively these two clinical effectivenesses further sum up the specificity anti-adhesion effectiveness that contains ficin dentifrice and are better than containing caricin dentifrice.
[0021] the batch product made of GMP was deposited for 6 weeks under 49 ℃.The enzymatic activity of every kind of enzyme is compared with initial activity almost and is not changed.
EXAMPLE IV: the dentifrice formulation that contains anti-stick outstanding enzyme and antibacterial
[0022] except the amount and exemplary antibacterial CPC replacement that reduce water with respective amount, the step of example I above repeating.Corresponding as in the table 1, water reduces to 16.7% of weight, is 0.3% of weight for every kind of CPC that contains in three kinds of preparations.
Claims (17)
1. composition for oral cavity that comprises the antitack agent that contains ficin, described antitack agent exists with the amount of effectively slowing down subject oral cavity and dental plaque and forming interaction between substances.
2. the compositions of claim 1, wherein, composition for oral cavity is by 100 weight portions, and then the amount of antitack agent is up to about 10 parts.
3. one kind comprises the composition for oral cavity that accounts for 0.01 part antitack agent in per by weight 100 parts of compositionss at least, and wherein said antitack agent comprises the cysteine proteinase that milk-clotting activity is higher than caricin.
4. the compositions of claim 3, wherein, composition for oral cavity is by 100 weight portions, and then the amount of antitack agent is about 10 parts of about 0.01-.
5. the compositions of claim 3, wherein, composition for oral cavity is by 100 weight portions, and then the amount of antitack agent is at least about 0.05 part.
6. the compositions of claim 3, wherein, composition for oral cavity is by 100 weight portions, and then the amount of antitack agent is about 0.3 part of about 0.03-.
7. the compositions of claim 3, wherein antitack agent comprises more than a kind of cysteine proteinase.
8. the compositions of claim 7, wherein cysteine proteinase comprise with caricin and Antarctic krill protease in the ficin of at least a coupling.
9. the compositions of claim 7, it further comprises at least a enzyme that is different from cysteine proteinase.
10. the compositions of claim 9, wherein said different enzyme is at least a enzyme that is selected from amylase, lipase, nuclease and other protease.
11. a method that reduces dental plaque growth in the subject oral cavity, described method comprises makes the oral cavity contact with the anti-adhesion protease of effective dose, thereby slows down the interaction between subject oral cavity and the dental plaque formation material.
12. a composition for oral cavity that comprises antitack agent, described antitack agent comprises ficin and antibacterial.
13. the compositions of claim 1, wherein antitack agent further comprises at least a caricin and Antarctic krill protease.
14. the compositions of claim 1, wherein antibacterial comprises cationic antibacterial agent.
15. the compositions of claim 1, wherein antibacterial comprises quaternary ammonium compound.
16. the compositions of claim 1, wherein antibacterial comprises halogenated alkyl pyridine .
17. a composition for oral cavity, described compositions have at least a antibacterial of cetyl pyridinium and the anti-adhesion protease that at least a milk-clotting activity is higher than caricin of comprising.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US63678804P | 2004-12-16 | 2004-12-16 | |
| US60/636,788 | 2004-12-16 | ||
| US60/636,787 | 2004-12-16 | ||
| US11/244,663 | 2005-10-06 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410298607.2A Division CN104127328A (en) | 2004-12-16 | 2005-11-28 | Oral compositions for prevention and reduction of bacterial adhesion to oral surfaces |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101119769A true CN101119769A (en) | 2008-02-06 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA200580048166XA Pending CN101119769A (en) | 2004-12-16 | 2005-11-28 | Oral compositions for prevention and reduction of bacterial adhesion to oral surfaces |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN101119769A (en) |
| ZA (1) | ZA200705097B (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102711661A (en) * | 2010-01-29 | 2012-10-03 | 高露洁-棕榄公司 | Dental strip for administration of oral treatment |
| CN105873603A (en) * | 2013-12-19 | 2016-08-17 | 雀巢产品技术援助有限公司 | Compositions and methods for reducing cat allergens in the environment |
| CN110519993A (en) * | 2017-05-09 | 2019-11-29 | 诺维信公司 | Animal chew toy with dental care compositions |
-
2005
- 2005-11-28 CN CNA200580048166XA patent/CN101119769A/en active Pending
-
2007
- 2007-06-14 ZA ZA200705097A patent/ZA200705097B/en unknown
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102711661A (en) * | 2010-01-29 | 2012-10-03 | 高露洁-棕榄公司 | Dental strip for administration of oral treatment |
| CN105963279A (en) * | 2010-01-29 | 2016-09-28 | 高露洁-棕榄公司 | Dental strip for administration of oral treatment |
| CN105873603A (en) * | 2013-12-19 | 2016-08-17 | 雀巢产品技术援助有限公司 | Compositions and methods for reducing cat allergens in the environment |
| CN110519993A (en) * | 2017-05-09 | 2019-11-29 | 诺维信公司 | Animal chew toy with dental care compositions |
Also Published As
| Publication number | Publication date |
|---|---|
| ZA200705097B (en) | 2008-09-25 |
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Application publication date: 20080206 |