CN106729656B - Oral care composition for treating dry mouth and application of oral care composition in toothpaste - Google Patents

Oral care composition for treating dry mouth and application of oral care composition in toothpaste Download PDF

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CN106729656B
CN106729656B CN201611113599.5A CN201611113599A CN106729656B CN 106729656 B CN106729656 B CN 106729656B CN 201611113599 A CN201611113599 A CN 201611113599A CN 106729656 B CN106729656 B CN 106729656B
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extract
stirring
toothpaste
oral care
ethanol
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CN106729656A (en
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江山
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Guangdong Jiuke Biotechnology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/898Orchidaceae (Orchid family)
    • A61K36/8984Dendrobium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968Ophiopogon (Lilyturf)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8969Polygonatum (Solomon's seal)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/44Oxidoreductases (1)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/44Oxidoreductases (1)
    • A61K38/443Oxidoreductases (1) acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/47Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64Proteins; Peptides; Derivatives or degradation products thereof
    • A61K8/66Enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/005Antimicrobial preparations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Abstract

The invention discloses an oral care composition for treating dry mouth and application thereof in toothpaste. The oral care composition for treating the dry mouth comprises Chinese herbal medicine extracts and biological enzymes, wherein the Chinese herbal medicine extracts are more than one of dendrobium extract, polygonatum extract and ophiopogon root extract; the biological enzyme is more than one of lysozyme, lactoperoxidase, amylase, amyloglucosidase and glucose oxidase. The oral care composition of the present invention has the effect of alleviating dry mouth, on the one hand, stimulating salivary secretion, on the other hand, containing components similar to proteins or enzymes in saliva, acting as artificial saliva, and having bactericidal effect, and can alleviate discomfort of xerostomia after use.

Description

Oral care composition for treating dry mouth and application of oral care composition in toothpaste
Technical Field
The invention relates to the technical field of oral care products, in particular to an oral care composition for treating xerostomia and application thereof in toothpaste.
Background
Saliva plays an important role in lubricating and digesting food, cleaning the oral cavity, and protecting the oral cavity from chemical, mechanical, and infectious factors. Normal saliva contains antibodies, enzymes and buffers. It prevents the progression of caries by maintaining the normal pH of the oral environment, rendering it neutral, limiting the production of acid due to sugar degradation. Salivary enzymes act at the beginning of food digestion. Saliva also plays an important role in taste and speech.
Insufficient salivation can lead to dry mouth. Xerostomia is not clinically common, and the incidence rate is higher especially for the elderly. Other factors such as radiation therapy, antidepressants, and also anticholinergics, antiallergic drugs, antihistamines, antispasmodics, decongestants, and diuretics are more commonly used to cause dry mouth. Narcotic analgesics, chemotherapeutic drugs such as doxorubicin, have been reported to cause xerosis.
When the mouth is dry, food and bacteria adhere to the tooth surface, promoting plaque formation. Oral pH is also reduced, thus increasing the risk of caries. The oral flora can be changed, and the proportion of pathogenic bacteria related to the occurrence of caries, such as streptococcus mutans and actinomycetes, is obviously increased when being normal. Because caries in radiation therapy requires removal, poor health and infection can lead to the development of xerostomia syndrome. Chronic gingival infection can cause marginal periodontitis. Food particles enter the gap between the gums and teeth, providing for the growth of bacteria, which can develop into bad breath.
The dry mouth problem affects the number and choice of food consumed by the patient and increases the risk of insufficient nutritional intake. Loesche et al reported that these patients are more likely to avoid eating crunchy foods such as vegetables, dry foods such as bread, viscous foods such as peanut oil, and the like, when chewed. Therefore, the development of the oral care composition for treating the dry mouth has great social significance and market prospect.
Patent application publication No. CN105311404A relates to a formula for treating senile xerostomia, and the formula components and respective weights are as follows: 15 g of dendrobium, 15 g of polygonatum, 18 g of Chinese yam and 12 g of sealwort. Can effectively stimulate the secretion function of salivary glands and play a role in promoting the salivary glands to secrete saliva.
Patent publication No. CN101678217B relates to a composition for the treatment of xerostomia and conditions related thereto comprising olive oil, trimethylglycine and xylitol, which has a very good effect in increasing unstimulated saliva flow or alleviating the symptoms of xerostomia and improving the quality of life of the patients.
Patent application publication No. CN103561719A relates to an oral composition comprising an extract obtained from araliaceae, zingiberaceae, labiatae, leguminosae, solanaceae, punicaceae, asteraceae or a mixture thereof, having an effect of alleviating dry mouth.
In the process of treating xerostomia, the prior art often adopts a method of stimulating salivary secretion to increase the amount of saliva in the oral cavity, thereby relieving the xerostomia. Because of the short duration of action of the oral care composition in the oral cavity and the low residual levels of active in the oral cavity, the therapeutic effect of this method is not significant, especially for some people with hyposalivation. The prior art oral care compositions have a short duration of action in the oral cavity and low residual levels of actives; only plays a role in stimulating salivary secretion, and has no obvious effect on the population with hypofunction of salivary glands.
Disclosure of Invention
The invention aims to provide an oral care composition for treating dry mouth and application thereof in toothpaste. Has the effect of relieving xerostomia, can stimulate saliva secretion, contains components similar to proteins or enzymes in saliva, has artificial saliva function, and has antibacterial effect, and can relieve xerostomia.
The purpose of the invention is realized by the following technical scheme.
An oral care composition for treating xerostomia comprises Chinese herbal medicine extract and biological enzyme, wherein the Chinese herbal medicine extract is more than one of herba Dendrobii extract, rhizoma Polygonati Odorati extract and radix Ophiopogonis extract;
the biological enzyme is more than one of lysozyme, lactoperoxidase, amylase, amyloglucosidase and glucose oxidase.
The extraction process of the radix ophiopogonis extract comprises the steps of crushing the radix ophiopogonis into 5-20-mesh coarse particles, adding 80% wt ethanol with the mass being 1-2 times of that of the coarse particles for extraction for 2-5 hours, volatilizing the ethanol, drying, weighing the extract, adding water with the mass being 4-8 times of that of the extract, and extracting for 3 times with 1-2 hours each time; collecting water extract, filtering, adding 95% by weight of ethanol, standing overnight, collecting lower-layer precipitate, drying in an oven at 50-60 ℃ to constant weight, pulverizing, and sieving to obtain radix Ophiopogonis extract;
the extraction process of the dendrobe extract comprises the steps of coarsely crushing dendrobe into 1-3 cm dendrobe coarse powder, adding 2-5 times of pure water by mass, leaching for 3 times, each time for 40-80 minutes, collecting water extract, and concentrating to obtain extract, wherein the leaching temperature is 90-100 ℃; adding ethanol with the mass of 3-6 times of the extract, stirring for 20 minutes, and standing for 24 hours; collecting the ethanol precipitate, drying at the temperature of 60-65 ℃ and the vacuum degree of 0.04-0.06 Mp, crushing and sieving to obtain the dendrobium extract;
the extraction process of the polygonatum extract comprises the steps of coarsely crushing polygonatum into 1-3 cm coarse powder, adding 10-15 times of pure water by mass to extract for 1-3 hours, collecting water extract at the extraction temperature of 90-100 ℃, filtering and concentrating the water extract to obtain extract, adding 4-6 times of ethanol by mass to the extract, stirring for 30 minutes, precipitating and standing for 24 hours; collecting the ethanol precipitate, drying under reduced pressure, pulverizing, and sieving to obtain rhizoma Polygonati Odorati extract.
Furthermore, since the biological enzyme is easily affected by temperature and other components in the formula in the oral care product, the biological enzyme loses activity, especially the ionic surfactant commonly used in the oral care product, such as sodium lauryl sulfate and the like; chelating agents, such as polyphosphates and the like; preservatives, flavors and the like can all lead to inactivation of enzymes in the formula, thereby reducing the efficacy of the product.
The invention adopts a special packaging technology to package the biological enzyme in the formula, and then the biological enzyme is added into the oral care product, so that the stability of the enzyme activity is better maintained.
An oral care composition for treating xerostomia comprises Chinese herbal medicine extract and biological enzyme microspheres, wherein the Chinese herbal medicine extract is more than one of dendrobium extract, polygonatum extract and ophiopogon root extract;
the biological enzyme microspheres are microspheres wrapped with biological enzymes, and the biological enzymes are more than one of lysozyme, lactoperoxidase, amylase, amyloglucosidase and glucose oxidase;
the biological enzyme microspheres comprise the following components in parts by weight:
Figure GDA0002288337480000021
the preparation method of the biological enzyme microspheres comprises the following steps:
(1) adding the adhesive into boiling water under the stirring condition, stirring for 20-40 min, cooling to below 40 ℃, homogenizing, adding the biological enzyme, homogenizing and stirring for 10-20 min;
(2) adopting fluidized bed equipment, and the air quantity is 1100-1150 m3H, spraying the material prepared in the step (1) onto a core under the conditions that the air inlet temperature is 45-75 ℃ and the pressure of a spray gun is 0.24-0.3 MPa, and drying until the material temperature reaches 30-50 ℃ to obtain microspheres;
(3) adding the protective film into alcohol with the mass of 10 times and the temperature of 40-50 ℃, stirring until the protective film is completely dissolved to obtain alcohol solution of the protective film, and using fluidized bed equipment to ensure that the air volume is 1000-1150 m3H, spraying the protective film alcohol solution onto the microspheres under the conditions that the air inlet temperature is 35-55 ℃ and the pressure of a spray gun is 0.16-0.20 MPa; and drying at 35-60 ℃ to obtain the biological enzyme microspheres.
Drying at 45-75 ℃ for 10-20 min until the temperature of the material reaches 30-50 ℃, and stopping drying to obtain microspheres;
the drying in the step (3) is preferably 20 min.
The adhesive is preferably selected from more than one of corn starch adhesive, microcrystalline cellulose, cellulose and cyclodextrin;
the core is preferably selected from more than one of mannitol, sorbitol, erythritol, silicon dioxide and lactose;
the protective film is preferably selected from more than one of hydroxypropyl methyl cellulose, ethyl cellulose and polylactic acid;
the extraction process of the radix ophiopogonis extract comprises the following steps: crushing the ophiopogon japonicus into coarse particles of 5-20 meshes, adding 80 wt% of ethanol with the mass of 1-2 times of that of the ophiopogon japonicus, extracting for 2-5 hours, volatilizing the ethanol, drying, weighing the extract, adding 4-8 times of water, and extracting for 3 times, wherein each time lasts for 1-2 hours; collecting water extract, filtering, adding 95% by weight of ethanol, standing overnight, collecting lower-layer precipitate, drying in an oven at 50-60 ℃ to constant weight, pulverizing, and sieving to obtain radix Ophiopogonis extract.
The content of ophiopogonpolysaccharide in the ophiopogon japonicus extract is 1-20 wt%, preferably 8-15 wt% of the extract;
the extraction process of the dendrobium extract comprises the following steps: coarsely crushing the dendrobium into 1-3 cm dendrobium coarse powder, adding 2-5 times of pure water by mass, leaching for 3 times, each time for 40-80 minutes, collecting water extract at the leaching temperature of 90-100 ℃, concentrating to obtain extract, adding 3-6 times of ethanol by mass, stirring for 20 minutes, and precipitating and standing for 24 hours; collecting the ethanol precipitate, drying at the temperature of 60-65 ℃ and the vacuum degree of 0.04-0.06 Mp, crushing and sieving to obtain the dendrobium extract.
The content of the dendrobium polysaccharide in the dendrobium extract is 3-20 wt%, and preferably 5-15 wt% of the extract.
The extraction process of the polygonatum odoratum extract comprises the following steps: coarsely crushing polygonatum odoratum into 1-3 cm coarse powder, adding 10-15 times of pure water by mass, extracting for 1-3 hours at 90-100 ℃, collecting a water extract, filtering and concentrating the water extract to obtain an extract, adding 4-6 times of ethanol by mass of the extract, stirring for 30 minutes, precipitating and standing for 24 hours; collecting the ethanol precipitate, drying under reduced pressure, pulverizing, and sieving to obtain rhizoma Polygonati Odorati extract.
The content of dendrobe polysaccharide in the polygonatum extract is 3-30%, and 10-25% of the extract is preferred.
The composition can be used in toothpaste, dentifrice, mouthwash, mouth spray, mouth rinse, mouth spray, chewing gum, mouth syrup, liquid dentifrice, chewing gum, candy or lozenge product, and has effects of stimulating salivary secretion and relieving dry mouth.
In another aspect, the invention provides an application of an oral care composition for treating dry mouth in toothpaste, wherein the toothpaste comprises the following components in parts by weight:
Figure GDA0002288337480000031
the lysozyme accounts for 0.075 to 3.0 percent of the total weight of the toothpaste; preferably 0.1% to 1.5%, particularly preferably 0.3% to 1.0%.
The lactoperoxidase accounts for 0.05 to 2.0 percent of the total weight of the toothpaste; preferably 0.1% to 1%; particularly preferably 0.1% to 0.3%;
the weight percentage of the amylase in the total weight of the toothpaste is 0.05-2.0%; preferably 0.1% to 1%, particularly preferably 0.1% to 0.3%;
the weight percentage of the amyloglucosidase in the total weight of the toothpaste is 0.05-2.0%; preferably 0.1% to 1%, particularly preferably 0.1% to 0.3%;
the glucose oxidase accounts for 0.075 to 3.0 percent of the total weight of the toothpaste. Preferably 0.1% to 1.5%, particularly preferably 0.3% to 1.0%;
the polygonatum extract accounts for 0.075 to 1.00 percent of the total weight of the toothpaste; preferably from 0.08% to 0.75%, particularly preferably from 0.1% to 0.25%.
The dendrobium extract accounts for less than 0.75 percent of the total weight of the toothpaste; preferably from 0.01% to 0.10%, particularly preferably from 0.03% to 0.08%.
The radix ophiopogonis extract accounts for 0.075-1.00% of the total weight of the toothpaste. Preferably 0.1% to 0.75%, particularly preferably 0.1% to 0.5%.
On the other hand, the invention also provides a preparation method of the toothpaste, which comprises the following steps:
(1) adding sodium fluoride, xylitol, saccharin sodium and the oral care composition of claim 1 or 3 into water, and stirring for 20-30 min to obtain an aqueous solution;
(2) uniformly mixing sorbitol, glycerol and polyethylene glycol, adding the mixture into an aqueous solution, stirring for 10-15 min to obtain a water mixed solution, and uniformly mixing carbomer, cellulose gum, silicon dioxide and sodium dodecyl sulfate to obtain powder;
(3) sucking the water mixed solution into a paste making machine, starting stirring, and adding the powder; controlling the vacuum degree to be 0.04-0.06 MPa, stirring for 15-20 min, adding essence and betaine, stirring for 3-5 min, vacuumizing to maximize the vacuum degree, stirring for 20-30 min, and stopping stirring.
The oral care composition may take any dosage form for oral administration. Illustrative examples of these compositions include: dentifrices such as toothpaste, dental gel, toothpaste or tooth powder; mouthwash, mouthrinse or mouth spray; an oral syrup or liquid dentifrice; chewing gum or other confectionery; a lozenge; dental floss or dental tape; functional film or gel flakes or functional millimeter, micron or nanoparticles; film-forming compositions comprising a pre-gel or pre-polymer, such as film-forming dentifrices, dental paints; a dental hardening agent.
The oral care composition of the present invention further comprises an agent for increasing salivation, reducing the sensation of dry mouth or dry mouth, which is not the biological enzymes and herbal extracts described, or mixtures thereof. Examples of such agents include, but are not limited to, one or more of xylitol, betaine, fructooligosaccharide, erythritol, mannitol, citric acid, lactic acid, malic acid.
The oral care composition of the present invention further comprises other macromolecular polymers for saliva replacement, relieving dry mouth discomfort, including but not limited to one or more of carbomers, poloxamers, xanthan gum, sodium carboxymethylcellulose, polyvinylpyrrolidone, and the like.
The oral care compositions of the present invention further comprise a fluoride ion source including, but not limited to, one or more of stannous fluoride, sodium fluoride, amine fluoride, ammonium fluoride, stannous monofluorophosphate, and sodium monofluorophosphate.
Abrasives may be added to the dentifrice formulation if desired. Any suitable oral care abrasive or polishing agent can be used. Abrasives such as silicas, calcined alumina, sodium bicarbonate, calcium carbonate, dicalcium phosphate and calcium pyrophosphate may be included in the matrix oral care composition used in the practice of the present invention.
Humectants can be added to the dentifrice formulation if desired. Any suitable oral care humectant can be used. Humectants such as sorbitol, glycerin, propylene glycol, PEG, and the like may be included in oral care compositions for use in the practice of the present invention. Any other additives may be included in the dentifrice composition, if desired, for reasons such as manufacturing, stability, aesthetics, therapeutic effect, consumer appeal (consumer appeal), and the like. Exemplary additives include all other conventional dentifrice additives, viscosity modifiers, diluents, foam modulators, desensitizing agents, whitening agents, pH modifying agents, mouth feel agents, sweeteners, colorants, opacifiers, and breath fresheners.
Compared with the prior art, the invention has the advantages and beneficial effects that:
(1) the action of Chinese herbs is to promote the production of body fluid, i.e. stimulate the production of saliva. The enzyme is an important component of saliva, and the added enzyme has the effect of artificial saliva on one hand, and is beneficial to oral health for reducing oral bacteria on the other hand.
(2) The Chinese herbal medicines and the enzymes selected by the invention have synergistic effect, and the effect of adding the Chinese herbal medicines and the enzymes is far better than the effect of independently using the Chinese herbal medicines and the enzymes.
(3) In the formula, the problem of unstable inactivation caused by the independent addition of the enzyme is solved, and the biological enzyme in the formula is wrapped by adopting a special wrapping technology and then added into the oral care product, so that the stability of the enzyme activity is better maintained.
(4) The Chinese herbal medicines are added separately in places with bad color, smell and the like, and the invention extracts the Chinese herbal medicines, thereby overcoming the defects.
Detailed Description
The extraction process of the ophiopogon japonicus extract in this embodiment: pulverizing radix Ophiopogonis into 20 mesh coarse particles, extracting with 2 times of 80% wt ethanol for 2 hr, volatilizing ethanol, oven drying, weighing the above extract, adding 4 times of water, and extracting for 3 times, each for 1 hr; collecting water extractive solution, filtering, adding 95% ethanol, standing overnight, collecting lower layer precipitate, oven drying at 50 deg.C to constant weight, pulverizing, and sieving to obtain radix Ophiopogonis extract.
The extraction process of the dendrobium extract comprises the following steps: coarsely pulverizing herba Dendrobii into 1cm coarse powder, adding 5 times of pure water, extracting for 3 times (each time for 80 min) at 100 deg.C, collecting water extractive solution, and concentrating to obtain extract. Adding ethanol with the weight 6 times that of the extract, stirring for 20 minutes, and standing for 24 hours; collecting ethanol precipitate, drying at 65 deg.C under vacuum degree of 0.06Mp, pulverizing, and sieving to obtain herba Dendrobii extract.
The extraction process of the polygonatum odoratum extract comprises the following steps: coarsely crushing polygonatum odoratum into coarse powder of 3cm, adding pure water of which the mass is 15 times that of the coarse powder, extracting for 3 hours at the extraction temperature of 100 ℃, collecting water extract, filtering and concentrating the water extract to obtain extract, adding ethanol of which the mass is 6 times that of the extract, stirring for 30 minutes, and settling and standing for 24 hours; collecting the ethanol precipitate, drying under reduced pressure, pulverizing, and sieving to obtain rhizoma Polygonati Odorati extract.
Examples 1 to 5
The invention relates to application of a composition for treating dry mouth in toothpaste. The toothpaste with the effect of treating dry mouth is prepared according to the following formula and a production process.
The production preparation process of the above examples 1-5 is as follows:
Figure GDA0002288337480000051
Figure GDA0002288337480000061
according to the preparation process of the biological enzyme, the biological enzyme in the formula is mixed to prepare biological enzyme microspheres; the preparation method of the biological enzyme microspheres comprises the following steps:
(1) weighing water according to the formula ratio, heating to boil, adding the starch adhesive under stirring, and stirring for 30 min;
(2) cooling the starch adhesive mixed solution to 30 ℃, homogenizing, adding biological enzyme, and homogenizing for 10 min;
(3) adopts fluidized bed equipment and sets the parameter air volume 1150m3And H, spraying the material flow prepared in the step (2) onto a mannitol core under the conditions that the air inlet temperature is 65 ℃ and the pressure of a spray gun is 0.24 MPa.
(4) After spraying, closing the spray gun, drying at 65 ℃ for 10min until the temperature of the materials reaches 30 ℃, and stopping drying;
(5) weighing hydroxypropyl methylcellulose with the formula ratio, adding into hot alcohol with the mass of 10 times and the temperature of 40 ℃, and stirring until the hydroxypropyl methylcellulose is completely dissolved;
(6) continuing to use the fluidized bed equipment, parameter setting: air volume 1000m3And H, spraying the hydroxypropyl methyl cellulose alcohol solution prepared in the step (5) onto the microspheres prepared in the step (4) under the conditions that the air inlet temperature is 35 ℃ and the pressure of a spray gun is 0.160 MPa.
(7) And (3) after the spraying is finished, closing the spray gun, and drying at 60 ℃ for 20min to obtain the biological enzyme microspheres.
Figure GDA0002288337480000062
Method of making an oral care composition: the prepared bio-enzyme microspheres (examples 1 and 3) or bio-enzyme (example 2) are mixed with the herbal extracts uniformly to obtain the oral care composition.
Figure GDA0002288337480000063
The application of the oral care composition in the toothpaste comprises the following steps:
(1) adding sodium fluoride, xylitol, saccharin sodium and the prepared oral care composition into water, and stirring for 20min to obtain an aqueous solution;
(2) mixing sorbitol, glycerol and PEG uniformly, adding into the water solution, stirring for 10min to obtain water mixed solution, and mixing carbomer, CMC, silicon dioxide and sodium dodecyl sulfate uniformly to obtain powder;
(3) sucking the water mixed solution into a paste making machine, starting stirring, and adding the powder; controlling vacuum degree at 0.04MPa, stirring for 15min, adding essence and betaine, stirring for 3min, vacuumizing to maximize vacuum degree (-0.1MPa), stirring for 20min, and stopping stirring.
Examples 6 to 9
The invention relates to application of a composition for treating dry mouth in a mouth wash. The gargle with the effect of treating xerostomia is prepared according to the following formula and production process.
Figure GDA0002288337480000071
Method of making an oral care composition: mixing biological enzyme and Chinese herbal medicine extract uniformly to obtain oral care composition.
The mouthwash of examples 6-9 above was prepared as follows:
(1) dissolving poloxamer and betaine in water, stirring for 15min to dissolve completely, adding essence, and stirring for 5 min; sequentially adding the obtained oral care composition, sorbitol, saccharin sodium, xylitol, and sodium fluoride into the above aqueous solution, stirring for 30min, and standing to obtain aqueous solution;
(2) dispersing CMC and carbomer into glycerol, stirring for 5min, and dispersing uniformly;
(3) and (3) adding the glycerol mixed solution obtained in the step (2) into the aqueous solution obtained in the step (1), and stirring for 30min to obtain the glycerol mixed solution.
Examples stability examination of biological enzymes
The toothpastes prepared in example 1, example 2 (unencapsulated bio-enzyme), example 3, and examples 6 to 8 were placed in a thermostat at 40 ℃ and 75 humidity to evaluate the stability by accelerated aging. Sampling and detecting the retention of enzyme activity in the product at the beginning, 1 month, 2 months and 3 months respectively.
The detection results are as follows:
example 1 Example 2 Example 3 Example 6 Example 7 Example 8
Initiation of 100% 100% 100% 100% 100% 100%
1 month 94% 80% 95% 70% 72% 79%
2 months old 89% 65% 90% 60% 62% 65%
3 months old 85% 47% 88% 42% 43% 46%
The results show that the stability of the coated biological enzyme in the formula is remarkably improved, and the activity of the enzyme in the formula can still reach more than 85% after 3 months of high-temperature accelerated aging.
[ Effect verification of example ]
Efficacy of the composition of the invention on adult populations suffering from symptoms of hyposalivation and xerostomia.
Test objects: a total of 80 subjects were recruited and enrolled from the general population between the ages of 50-67. All objects met the following conditions:
self-evaluation with xerostomia;
unstimulated saliva flow equal to or less than 0.2 ml/min
Subjects volunteered to use only the coordinator-specified product at each stage of the study.
Subjects volunteered to assist in completing all of the follow-ups required for this study.
The test method comprises the following steps:
each subject was interviewed by the coordinator using the xerostomia questionnaire to learn the dry mouth symptoms of the subjects. The questionnaire was as follows:
Figure GDA0002288337480000081
the subjects were randomly divided into four groups. Each group consisted of 20 individuals, and the products of example 1, example 3, example 4, and example 5 were used, respectively. Brushing teeth in the morning and evening for 2 times a day according to a normal tooth brushing mode.
Before the test toothpaste is used by the subject, the dry mouth condition of the subject is recorded by a coordinator according to a questionnaire, and a baseline measurement is made.
On day 8 of the test product use by the subjects, all subjects returned to the study center. The coordinator recorded the dry mouth condition of the subject, and possible side reactions, according to the questionnaire.
The effect of the product on dry mouth treatment was evaluated by comparing the dry mouth of the subjects before and after the test product was used.
And (3) testing results:
a total of 78 subjects from 80 of the experiments completed all the tests. The other 2 reasons for exit are not product dependent. No adverse reaction is found in the experimental process. The test results are shown in the following table.
Figure GDA0002288337480000091
From the test results, it can be seen that the effect of adding both of the enzymes is much better than that of adding only the bio-enzyme in the comparison between the example 1 (enzyme + Chinese herbal medicine) and the example 3 (adding only the bio-enzyme), and in addition, the effect of adding both of the enzymes is much better than that of one of the Chinese herbal medicines in the comparison between the example 1 (enzyme + Chinese herbal medicine) and the example 4 (only Chinese herbal medicine). The product added with the biological enzyme and the Chinese herbal medicine extract has the effect of treating the dry mouth, which is obviously superior to the product only added with the Chinese herbal medicine extract or the biological enzyme. The product without adding biological enzyme and Chinese herbal medicine extract has almost no treatment effect.
Therefore, the composition for treating the dry mouth, which is prepared from the biological enzyme and the Chinese herbal medicine extract, has a remarkable effect and can relieve the dry mouth condition of the dry mouth population.
Variations and modifications to the above-described embodiments may occur to those skilled in the art, which fall within the scope and spirit of the above description. Therefore, the present invention is not limited to the specific embodiments disclosed and described above, and some modifications and variations of the present invention should fall within the scope of the claims of the present invention. Furthermore, although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims (10)

1. An oral care composition for treating dry mouth comprises a Chinese herbal medicine extract and a biological enzyme, wherein the Chinese herbal medicine extract is a mixture of a dendrobium extract, a polygonatum extract and an ophiopogon root extract;
the biological enzyme is a mixture of lysozyme, lactoperoxidase, amylase, amyloglucosidase and glucose oxidase;
the biological enzyme comprises the following components in parts by weight:
0.3 of lysozyme;
amyloglucosidase 0.1;
0.2 parts of glucose oxidase;
0.05-0.1 parts of emulsified oxidase;
the Chinese herbal medicine extract comprises the following components in parts by weight:
0.05 parts of dendrobium extract;
0.1 of dwarf lilyturf tuber extract;
rhizoma Polygonati Odorati extract 0.3.
2. The oral care composition according to claim 1, wherein the radix ophiopogonis extract is obtained by pulverizing radix ophiopogonis into 5-20 mesh coarse particles, adding 1-2 times of 80% wt ethanol for extraction for 2-5 h, volatilizing ethanol, drying, weighing the extract, adding 4-8 times of water for extraction for 3 times, and extracting for 1-2 h each time; collecting water extract, filtering, adding 95% by weight of ethanol, standing overnight, collecting lower-layer precipitate, drying in an oven at 50-60 ℃ to constant weight, pulverizing, and sieving to obtain radix Ophiopogonis extract;
the extraction process of the dendrobe extract comprises the steps of coarsely crushing dendrobe into 1-3 cm dendrobe coarse powder, adding 2-5 times of pure water by mass, leaching for 3 times, each time for 40-80 minutes, collecting water extract, and concentrating to obtain extract, wherein the leaching temperature is 90-100 ℃; adding ethanol with the mass of 3-6 times of the extract, stirring for 20 minutes, and standing for 24 hours; collecting the ethanol precipitate, drying at the temperature of 60-65 ℃ and the vacuum degree of 0.04-0.06 Mp, crushing and sieving to obtain the dendrobium extract;
the extraction process of the polygonatum extract comprises the steps of coarsely crushing polygonatum into 1-3 cm coarse powder, adding 10-15 times of pure water by mass to extract for 1-3 hours, collecting water extract at the extraction temperature of 90-100 ℃, filtering and concentrating the water extract to obtain extract, adding 4-6 times of ethanol by mass to the extract, stirring for 30 minutes, precipitating and standing for 24 hours; collecting the ethanol precipitate, drying under reduced pressure, pulverizing, and sieving to obtain rhizoma Polygonati Odorati extract.
3. An oral care composition for treating xerostomia, which is characterized by comprising Chinese herbal medicine extracts and biological enzyme microspheres, wherein the Chinese herbal medicine extracts are a mixture of dendrobium extract, polygonatum extract and ophiopogon root extract;
the biological enzyme microspheres are microspheres wrapped with biological enzyme, and the biological enzyme is a mixture of lysozyme, lactoperoxidase, amylase, amyloglucosidase and glucose oxidase;
the biological enzyme microspheres comprise the following components in parts by weight:
Figure FDA0002700174010000011
4. the oral care composition of claim 3, wherein the preparation method of the bio-enzyme microspheres comprises the following steps:
(1) adding the adhesive into boiling water under the stirring condition, stirring for 20-40 min, cooling to below 40 ℃, homogenizing, adding the biological enzyme, homogenizing and stirring for 10-20 min;
(2) adopting fluidized bed equipment, and the air quantity is 1100-1150 m3H, spraying the material prepared in the step (1) onto a core under the conditions that the air inlet temperature is 45-75 ℃ and the pressure of a spray gun is 0.24-0.3 MPa, and drying until the material temperature reaches 30-50 ℃ to obtain microspheres;
(3) adding the protective film into alcohol with the mass of 10 times and the temperature of 40-50 ℃, stirring until the protective film is completely dissolved to obtain alcohol solution of the protective film, and using fluidized bed equipment to ensure that the air volume is 1000-1150 m3H, spraying the protective film alcohol solution onto the microspheres under the conditions that the air inlet temperature is 35-55 ℃ and the pressure of a spray gun is 0.16-0.20 MPa; drying the mixture at the temperature of between 35 and 60 ℃,thus obtaining the biological enzyme microspheres.
5. The oral care composition according to claim 3, wherein the radix Ophiopogonis extract is prepared by pulverizing radix Ophiopogonis into 5-20 mesh coarse particles, adding 1-2 times of 80% wt ethanol for extraction for 2-5 h, volatilizing ethanol, oven drying, weighing the above extract, adding 4-8 times of water for extraction for 3 times, each time for 1-2 h; collecting water extract, filtering, adding 95% by weight of ethanol, standing overnight, collecting lower-layer precipitate, drying in an oven at 50-60 ℃ to constant weight, pulverizing, and sieving to obtain radix Ophiopogonis extract;
the extraction process of the dendrobe extract comprises the steps of coarsely crushing dendrobe into 1-3 cm dendrobe coarse powder, adding 2-5 times of pure water by mass, leaching for 3 times, each time for 40-80 minutes, collecting water extract, and concentrating to obtain extract, wherein the leaching temperature is 90-100 ℃; adding ethanol with the mass of 3-6 times of the extract, stirring for 20 minutes, and standing for 24 hours; collecting the ethanol precipitate, drying at the temperature of 60-65 ℃ and the vacuum degree of 0.04-0.06 Mp, crushing and sieving to obtain the dendrobium extract;
the extraction process of the polygonatum extract comprises the steps of coarsely crushing polygonatum into 1-3 cm coarse powder, adding 10-15 times of pure water by mass to extract for 1-3 hours, collecting water extract at the extraction temperature of 90-100 ℃, filtering and concentrating the water extract to obtain extract, adding 4-6 times of ethanol by mass to the extract, stirring for 30 minutes, precipitating and standing for 24 hours; collecting the ethanol precipitate, drying under reduced pressure, pulverizing, and sieving to obtain rhizoma Polygonati Odorati extract.
6. Use of the oral care composition of claim 1 or 3 in toothpaste, tooth powder, mouthwash, mouth spray, mouth rinse, mouth spray, chewing gum, mouth syrup, liquid dentifrice, chewing gum, candy or lozenge.
7. The use according to claim 6, wherein the toothpaste comprises the following components in parts by weight:
Figure FDA0002700174010000021
8. use according to claim 7, wherein the lysozyme represents from 0.075% to 3.0% by weight of the total weight of the toothpaste;
the lactoperoxidase accounts for 0.05 to 2.0 percent of the total weight of the toothpaste;
the weight percentage of the amylase in the total weight of the toothpaste is 0.05-2.0%;
the weight percentage of the amyloglucosidase in the total weight of the toothpaste is 0.05-2.0%;
the glucose oxidase accounts for 0.075 to 3.0 percent of the total weight of the toothpaste.
9. The use according to claim 7, wherein the polygonatum extract is present in an amount of 0.075 to 1.00% by weight based on the total weight of the toothpaste;
the dendrobium extract accounts for less than 0.75 percent of the total weight of the toothpaste;
the radix ophiopogonis extract accounts for 0.075-1.00% of the total weight of the toothpaste.
10. Use according to claim 7, characterized in that the toothpaste is prepared by a process comprising the following steps:
(1) adding sodium fluoride, xylitol, saccharin sodium and the oral care composition of claim 1 or 3 into water, and stirring for 20-30 min to obtain an aqueous solution;
(2) uniformly mixing sorbitol, glycerol and polyethylene glycol, adding the mixture into an aqueous solution, stirring for 10-15 min to obtain a water mixed solution, and uniformly mixing carbomer, cellulose gum, silicon dioxide and sodium dodecyl sulfate to obtain powder;
(3) sucking the water mixed solution into a paste making machine, starting stirring, and adding the powder; controlling the vacuum degree to be 0.04-0.06 MPa, stirring for 15-20 min, adding essence and betaine, stirring for 3-5 min, vacuumizing to maximize the vacuum degree, stirring for 20-30 min, and stopping stirring.
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