CN107929428B - Composition for oral cavity and application thereof - Google Patents

Abstract

The invention relates to a composition for oral cavity and application thereof. The composition comprises the following components in parts by weight: 0.05-5 parts by weight of phellodendron amurense bark extract; 0.1-5 parts by weight of a tomato fruit extract; 0.1-2 parts by weight of tea tree essential oil; 0.0001-2 parts of sodium azulene sulfonate. The oral product provided by the invention can effectively remove helicobacter pylori in the oral cavity, has a good treatment effect on gingivitis and oral ulcer, and also has a good auxiliary treatment effect on gastric ulcer.

Description

Composition for oral cavity and application thereof

Technical Field

The invention relates to a composition for an oral cavity and application thereof, belonging to the technical field of daily chemical products.

Background

Helicobacter pylori is a spiral, gram-negative, microaerophilic bacterium, which is currently the most prevalent bacterium for human infection. Statistically, about half of the world's population is infected with H.pylori. Helicobacter pylori enters a low-pH environment in the stomach of a human body, can grow and reproduce and cause tissue damage, and the pathogenic effect of the helicobacter pylori is mainly shown as follows: the colonization of the gastric mucosa by bacteria, the invasion of the host's immune defense system, the direct action of toxins and the induced inflammatory and immunological reactions. Chronic infection with helicobacter pylori causes chronic gastritis, and leads to atrophy of the gastric mucosa and metaplasia of the intestinal epithelium, with an increased chance of dysplasia and canceration.

The helicobacter pylori generally spreads by mouth entering, most patients show occult general symptoms without bacterial infection after being infected by the helicobacter pylori, and also often have no acute-phase symptoms of gastritis, and clinically patients often see a doctor with chronic gastritis, peptic ulcer and the like. At this time, the disease is serious and difficult to cure radically, and the disease is easy to relapse even after being cured. Because the existing method for treating chronic gastritis and peptic ulcer mainly kills helicobacter pylori by taking a plurality of antibiotics, the use of the antibiotics can strengthen the drug resistance of the helicobacter pylori, which is easy to cause repeated attack of diseases and increases the treatment difficulty. In addition, even if helicobacter pylori in the stomach is eliminated by taking the medicine, a large amount of helicobacter pylori remains in the oral cavity, and infection continues after entering the stomach, resulting in relapse of old disease.

Helicobacter pylori is generally present in dental plaque, oral mucosa, gingival pocket and saliva in oral cavity, so that after oral cavity infection, odorous compounds are generated to cause halitosis. Meanwhile, gingival inflammation is also one of the causes of halitosis, and the site with gingival inflammation and oral ulcer are the harboring sites for helicobacter pylori, so in addition to eliminating helicobacter pylori in the oral cavity, it is also necessary to treat gingival inflammation and oral ulcer of the patient.

Keeping the oral cavity clean by brushing teeth, gargling and the like is a simple way to effectively prevent oral problems, but the use of ordinary oral preparations is far from sufficient for preventing oral infection with helicobacter pylori.

Disclosure of Invention

In order to solve the technical problems, the invention provides an oral product which not only can clean the oral cavity, but also can effectively remove helicobacter pylori in the oral cavity, has good treatment effect on gingivitis and oral ulcer, and also has good auxiliary treatment effect on gastric ulcer.

The invention is realized by adopting the following technical scheme.

The composition for the oral cavity comprises the following components in parts by weight:

preferably, the composition comprises the following components in parts by weight:

in the invention, the phellodendron amurense bark extract contains various alkaloids such as berberine, magnoflorine, phellodendrine and palmatine, and lactones, sterols, mucoids and the like, can clear heat and dry dampness, purge fire and remove steam, detoxify and cure sore, and has inhibiting effects on various pathogenic bacteria to different degrees.

The tomato fruit extract is prepared by extracting and refining natural plant tomatoes, and the active component of the tomato fruit extract is lycopene. Scientific research shows that the tomato fruit extract is not only a basic nutrient component of a human body, but also has unique pharmacological actions in the aspects of enhancing the immunologic function of the human body, inhibiting mutagenesis, resisting oxidation and the like.

The tea tree essential oil is extract of tea tree, contains ethylene (terpinene), terpineol (pinene), limonene (limonene), eucalyptol (cineole), terpineol (terpineol), and cumine (cumene), and has effects of killing bacteria, relieving inflammation, astringing follicular orifice, treating common cold, cough, rhinitis, asthma, and improving dysmenorrhea, menoxenia and genital infection.

The sodium guaiazulene sulfonate (also called guaiazulene sulfonate) is prepared by adding water-soluble groups to the molecular structure of guaiazulene. The sodium azulene sulfonate has excellent anti-inflammatory effect, can promote healing of burn and scald wounds and ulcer wounds and granulation regeneration, has multiple functions of heat prevention, radiation protection, chapping prevention and the like, and can be used for treating various diseases.

The raw materials selected by the invention are safe to human bodies, environment-friendly and have different pharmacological actions, and part of the raw materials have been found to have certain treatment effect on gingivitis. The invention creatively discovers that the compatibility and the combined use of the components can play a role in synergy, can effectively remove helicobacter pylori in oral cavity, has good treatment effect on gingivitis and oral ulcer, and also has good auxiliary treatment effect on gastric ulcer.

Preferably, the composition further comprises one or more of mulberry leaf extract, chrysanthemum extract, kudzu root extract and bupleurum root extract. Wherein the dosage of each component in the composition is as follows:

the folium Mori extract contains folium Mori flavone, folium Mori polyphenol, folium Mori polysaccharide, DNJ, GABA and other physiological active substances, and can be used for preventing and treating cardiovascular disease and cerebrovascular disease, hyperlipidemia, diabetes, obesity and aging.

The flos Chrysanthemi extract contains abundant flavonoids and phenolic compounds, has effects of dispelling pathogenic wind, clearing heat, suppressing hyperactive liver, improving eyesight, dilating coronary artery, lowering blood pressure, preventing hyperlipemia, resisting bacteria, virus, inflammation and aging, and can be used for treating wind-heat type common cold, headache, giddiness, conjunctival congestion, swelling and pain, and dim eyesight.

The radix Puerariae extract is derived from dried root of Pueraria lobata Ohwi of Leguminosae, contains multiple flavonoids, and contains daidzein (daidzein), daidzin (daidzin), puerarin (puerarin), and puerarin-7-xyloside (puerarin-7-xyloside) as main active ingredients, and has effects of dilating blood vessel and improving blood circulation; reducing myocardial oxygen consumption, inhibiting cancer cells; increase coronary flow, regulate blood microcirculation; treating sudden deafness at various ages; reduce the risk of cardiovascular and cerebrovascular diseases.

The bupleuri radix extract is extracted from root of Umbelliferae plant bupleuri radix, bupleuri radix etc., contains volatile oil, bupleuri radix alcohol, oleic acid, linolenic acid, palmitic acid, stearic acid, glucose and saponin components, and has functions of clearing deficiency heat, removing infantile malnutrition heat, and can be used for treating fever due to yin deficiency, bone steaming, overstrain heat, and infantile malnutrition heat.

The invention unexpectedly discovers that the curative effect of the composition can be further remarkably improved by adding one or more of mulberry leaf extract, chrysanthemum extract, kudzu root extract and bupleurum extract into the composition.

The invention also provides application of the composition in any one technical scheme in preparation of a medicine or an oral care product for treating gingivitis, oral ulcer or gastric ulcer.

The invention also provides an oral care product comprising the composition according to any one of the above technical schemes.

The invention provides toothpaste which comprises the following components in parts by weight:

active components:

auxiliary materials:

preferably, the toothpaste comprises the following components in parts by weight:

active components:

auxiliary materials:

the abrasive is selected from one or more of silicon dioxide, hydrated calcium hydrophosphate, anhydrous calcium hydrophosphate, calcium carbonate, aluminum hydroxide or calcium pyrophosphate;

the humectant is selected from one or more of sorbitol, glycerol, propylene glycol, polyethylene glycol-8 or butanediol;

the foaming agent is selected from one or more of sodium dodecyl sulfate, sodium lauroyl sarcosinate, sodium cocoyl glycinate, sodium acyl glutamate or sodium cocoyl methyl taurate;

the thickening agent is selected from one or more of cellulose and derivatives thereof, guar gum, sodium alginate, xanthan gum, guar gum hydroxypropyl trimethyl ammonium chloride, carrageenan or locust bean;

the sweetener is selected from one or more of saccharin sodium, sucralose, xylitol, sodium cyclamate, aspartame, stevioside or mogroside;

the essence is selected from one or more of vanilla essence, spearmint essence, mint essence or wintergreen mint essence;

the preservative is selected from one or more of benzoic acid and salts thereof, sorbic acid and salts thereof or parabens;

the appearance modifier is selected from one or more of titanium dioxide, food pigment, food color lake or tooth cleaning particle;

the solvent is selected from deionized water.

Preferably, the toothpaste further comprises one or more of the following components:

the invention also provides a preparation method of the toothpaste, which comprises the following steps: mixing the above materials, and making toothpaste.

The preparation method of the toothpaste comprises the following steps:

A. dissolving cortex Phellodendri bark extract, fructus Lycopersici Esculenti fruit extract, tea tree essential oil, and azulene sodium sulfonate in humectant, stirring at high speed to obtain first mixed solution;

B. adding a thickening agent into the first mixed solution, and stirring to obtain a second mixed solution;

C. adding an appearance modifier into the second mixed solution, and stirring to obtain a third mixed solution;

D. adding the third mixed solution, the sweetening agent, the friction agent, the essence, the foaming agent and the preservative into the solvent, and stirring to obtain a fourth mixed solution;

E. the fourth mixed solution is continuously stirred under the vacuum condition of 0.08-0.12MPa to prepare paste.

F. Checking, aseptically filling into aluminum plastic composite tube, sealing, and making into toothpaste.

The invention also provides mouthwash which comprises the following components in parts by weight:

active components:

auxiliary materials:

the solvent is selected from deionized water;

the humectant is selected from one or more of sorbitol, propylene glycol, glycerol and polyethylene glycol-8;

the surfactant is selected from one or more of poloxamer 407, sodium lauryl sulfate, sodium lauroyl sarcosinate and sodium cocoyl methyl taurate;

the thickening agent is selected from one or more of cellulose, carbomer and carrageenan;

the edible essence is selected from one or more of flos Caryophylli, cortex Cinnamomi, flos Osmanthi Fragrantis, oleum Menthae Dementholatum, herb Hierochloes Adoratae essence, herba Menthae Rotundifoliae, herba Menthae Haplocalycis, and herba Menthae Dementholati;

the colorant is selected from one or more of green, blue and red.

More preferably, the mouthwash further comprises one or more of the following components:

the technical scheme of the invention has the following beneficial effects:

the invention utilizes different medicinal mechanisms of each component, fully exerts the synergistic interaction effect among the components, ensures that the obtained composition can effectively eliminate helicobacter pylori in oral cavity, has good treatment effect on gingivitis and oral ulcer, and also has good auxiliary treatment effect on gastric ulcer.

Detailed Description

The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.

Examples 1 to 3A composition for oral cavity

The formulations of comparative examples 1-2 and examples 1-3 are shown in Table 1.

Table 1: formulation of

In table 1, examples 1 to 3 are the compositions provided by the present invention, and when in specific use, the compositions can be mixed with appropriate excipients to prepare oral preparations such as toothpaste or mouthwash.

Examples 4 to 9A composition for oral use

The formulations of comparative examples 3 to 6 and examples 4 to 9 are shown in Table 2.

Table 2: formulation of

In table 2, examples 4 to 9 are the compositions provided by the present invention, and when in specific use, the compositions can be mixed with appropriate excipients to prepare oral preparations such as toothpaste or mouthwash.

Examples 10 to 12A toothpaste

In order to illustrate the advantages of the toothpaste, the toothpaste is prepared from the compositions in comparative examples 1-2 and examples 1-3 and appropriate auxiliary materials, and human trial tests are carried out to prove the beneficial effects of the toothpaste.

(1) The formulations of comparative examples 7 to 8 and examples 10 to 12 are shown in Table 3.

Table 3: formulation of

(2) Preparation method of toothpaste (when a certain toothpaste does not contain a certain component, the component is not added in the preparation process)

A. Dissolving cortex Phellodendri bark extract, fructus Lycopersici Esculenti extract, tea tree essential oil, and azulene sodium sulfonate in sorbitol and polyethylene glycol-8, stirring at high speed for 10min to obtain first mixed solution;

B. adding xanthan gum into the first mixed solution, and stirring for 10min to obtain a second mixed solution;

C. adding titanium dioxide into the second mixed solution, and stirring for 10min to obtain a third mixed solution;

D. adding water, saccharin sodium, xylitol, silicon dioxide, Mentha spicata, sodium cocoyl methyl taurate, and potassium sorbate into the third mixture, and stirring for 10min to obtain a fourth mixture;

E. the fourth mixed solution is continuously stirred for 15min under the vacuum condition of 0.08-0.12MPa to prepare paste.

F. Checking, aseptically filling into aluminum plastic composite tube, sealing, and making into toothpaste.

(3) Human body test (for gingivitis treatment)

Volunteers with gingival swelling and bleeding symptoms are selected to participate in the human body trial test of the toothpaste, the test samples are randomly divided into 25 persons in each group, the toothpaste in the embodiment and the comparative example is used for each group, the group is used once in the morning and at night every day, and the gingivitis treatment effect is investigated after four weeks.

The criteria for therapeutic effect are as follows:

and (3) curing: the subjective symptoms of the patient disappear, the gingival inflammation disappears completely, the damaged gingival connective tissue can see new collagen fibers, and the function, color, shape and quality of the gingiva are all recovered to be normal;

improvement: the patient's gingiva and gingival papilla are reddish, have slight edema, hyperemia, and are brittle, and have little punctate bleeding when the gingival sulcus is touched by a blunt round probe;

and (4) invalidation: the patient's gingiva still had swelling and pain, and bleeding was seen in probing without improvement of symptoms and signs.

The total effective rate of treatment is (cure + improvement)/total number of cases is multiplied by 100%.

The results are shown in Table 4:

(4) human body test (curative effect on canker sore)

Selecting more than 1 year with the history of oral ulcer; recurrent attacks, at least once a month; in the attack stage, and the attack time is within 48 hours; meanwhile, patients accompanied with halitosis participate in the test of the treatment effect of the toothpaste on the oral ulcer, the treatment effect is randomly divided into groups according to the number of test samples, 25 persons are respectively used in each group, the toothpaste in the embodiment and the comparative example is respectively used in the morning and the evening of each day, and the helicobacter pylori clearance in the oral cavity, the halitosis phenomenon disappearance rate and the treatment effect of the oral ulcer are detected after 8 weeks.

Evaluation indexes of oral ulcer treatment effect:

total pause time (days) (interval, I): evaluation period no sum of ulcer time.

Total ulcer number (number, N): the sum of the number of ulcer recurrences over the evaluation period.

Grading evaluation indexes:

I1-Total pause time extension (t test, P <0.05)

I0-Total pause time unchanged (t test, P >0.05)

N1-Total ulcer number decreased (t test, P <0.05)

N1-No change in Total ulcer number (t test, P >0.05)

Evaluation criteria:

and (3) healing: the oral ulcer can be stopped and recurred for more than one year

The effect is shown: I1N1

The method has the following advantages: I0N1 or I1N0

And (4) invalidation: I0N0

Effective rate (cure + effect)/total number of cases x 100%.

The results are shown in Table 5:

(5) human body test (auxiliary treatment effect for gastric ulcer)

Selecting the gastric ulcer with more than 2 years of history; recurrent attacks; the patients in the attack stage and within 48 hours of the attack time participate in the auxiliary treatment effect of the toothpaste on the gastric ulcer. The test samples are randomly grouped according to the number of the test samples, 25 persons are in each group, the toothpaste in the embodiment and the toothpaste in the comparative example are respectively used for one time in the morning and at the evening every day, the same dose of the gastric bismuth magnesium is simultaneously taken, the healing time of the gastric ulcer is counted, and the recurrence rate of the gastric ulcer in 12 months after self healing is counted.

The results are shown in Table 6:

from the above results, it can be seen that the toothpaste of the examples has significantly better effect than the toothpaste of the comparative examples at the same amount of the effective ingredients, indicating that the compositions used in the examples have synergistic effect.

EXAMPLES 13 to 18A toothpaste

In order to further illustrate the advantages of the invention, the compositions in comparative examples 3-6 and examples 4-9 and appropriate auxiliary materials are prepared into toothpaste, and human trial tests are carried out, so that the beneficial effects of the invention are further deeply proved.

(1) The formulations of comparative examples 9 to 12 and examples 13 to 18 are shown in Table 7.

Table 7: formulation of

(2) Preparation method (when a toothpaste contains no ingredients, the ingredients are not added in the preparation process)

A. Dissolving cortex Phellodendri bark extract, fructus Lycopersici Esculenti extract, tea tree essential oil, azulene sodium sulfonate, folium Mori extract, flos Chrysanthemi extract, radix Puerariae extract, and bupleuri radix extract in sorbitol and polyethylene glycol-8, stirring at high speed for 10min to obtain first mixed solution;

B. adding xanthan gum into the first mixed solution, and stirring for 10min to obtain a second mixed solution;

C. adding titanium dioxide into the second mixed solution, and stirring for 10min to obtain a third mixed solution;

D. adding water, saccharin sodium, xylitol, silicon dioxide, Mentha spicata, sodium cocoyl methyl taurate, and potassium sorbate into the third mixture, and stirring for 10min to obtain a fourth mixture;

E. the fourth mixed solution is continuously stirred for 15min under the vacuum condition of 0.08-0.12MPa to prepare paste.

F. Checking, aseptically filling into aluminum plastic composite tube, sealing, and making into toothpaste.

(3) Human body test (for gingivitis treatment)

Volunteers with symptoms of gingival swelling and bleeding are selected to participate in the human body use test of the toothpaste, the test samples are randomly divided into 25 persons in each group, the toothpaste in the embodiment and the comparative example is used for each group, the group is used once in the morning and at night every day, and the gingivitis treatment effect is investigated after four weeks.

The criteria for therapeutic effect are as follows:

and (3) curing: the subjective symptoms of the patient disappear, the gingival inflammation disappears completely, the damaged gingival connective tissue can see new collagen fibers, and the function, color, shape and quality of the gingiva are all recovered to be normal;

improvement: the patient's gingiva and gingival papilla are reddish, have slight edema, hyperemia, and are brittle, and have little punctate bleeding when the gingival sulcus is touched by a blunt round probe;

and (4) invalidation: the patient's gingiva still had swelling and pain, and bleeding was seen in probing without improvement of symptoms and signs.

The total effective rate of treatment is (cure + improvement)/total number of cases is multiplied by 100%.

The results are shown in Table 8:

(4) human body test (curative effect on canker sore)

Selecting more than 1 year with the history of oral ulcer; recurrent attacks, at least once a month; in the attack stage, and the attack time is within 48 hours; meanwhile, patients accompanied with halitosis participate in the test of the treatment effect of the toothpaste on the oral ulcer, the treatment effect is randomly divided into groups according to the number of test samples, 25 persons are respectively used in each group, the toothpaste in the embodiment and the comparative example is respectively used in the morning and the evening of each day, and the helicobacter pylori clearance in the oral cavity, the halitosis phenomenon disappearance rate and the treatment effect of the oral ulcer are detected after 8 weeks.

Evaluation indexes of oral ulcer treatment effect:

total pause time (days) (interval, I): evaluation period no sum of ulcer time.

Total ulcer number (number, N): the sum of the number of ulcer recurrences over the evaluation period.

Grading evaluation indexes:

I1-Total pause time extension (t test, P <0.05)

I0-Total pause time unchanged (t test, P >0.05)

N1-Total ulcer number decreased (t test, P <0.05)

N1-No change in Total ulcer number (t test, P >0.05)

Evaluation criteria:

and (3) healing: the oral ulcer can be stopped and recurred for more than one year

The effect is shown: I1N1

The method has the following advantages: I0N1 or I1N0

And (4) invalidation: I0N0

Effective rate (cure + effect)/total number of cases x 100%.

The results are shown in Table 9:

(5) human body test (auxiliary treatment effect for gastric ulcer)

Selecting the gastric ulcer with more than 2 years of history; recurrent attacks; the patients in the attack stage and within 48 hours of the attack time participate in the auxiliary treatment effect of the toothpaste on the gastric ulcer. The test samples are randomly grouped according to the number of the test samples, 25 persons are in each group, the toothpaste in the embodiment and the toothpaste in the comparative example are respectively used for one time in the morning and at the evening every day, the same dose of the gastric bismuth magnesium is simultaneously taken, the healing time of the gastric ulcer is counted, and the recurrence rate of the gastric ulcer in 12 months after self healing is counted.

The results are shown in Table 10:

the above results show that the obtained toothpaste can obtain a better effect by further adding one or more of mulberry leaf extract, chrysanthemum extract, kudzu root extract and bupleurum root extract, namely, the synergistic effect is achieved between one or more of mulberry leaf extract, chrysanthemum extract, kudzu root extract and bupleurum root extract and the composition consisting of phellodendron bark extract, tomato fruit extract, tea tree essential oil and azulene sodium sulfonate.

EXAMPLES 19 to 28A mouthwash

The formulations of examples 19-28 are shown in Table 11.

Table 11: formulation of

Although the invention has been described in detail hereinabove with respect to a general description and specific embodiments thereof, it will be apparent to those skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims (5)

1. An oral care product is characterized in that the active ingredients of the oral care product comprise the following components:

2. the oral care product of claim 1, wherein the active ingredients comprise:

3. the oral care product according to claim 1 or 2, when the oral care product is a toothpaste, further comprising:

the abrasive is selected from one or more of silicon dioxide, hydrated calcium hydrophosphate, anhydrous calcium hydrophosphate, calcium carbonate, aluminum hydroxide or calcium pyrophosphate;

the humectant is selected from one or more of sorbitol, glycerol, propylene glycol, polyethylene glycol-8 or butanediol;

the foaming agent is selected from one or more of sodium dodecyl sulfate, sodium lauroyl sarcosinate, sodium cocoyl glycinate, sodium acyl glutamate or sodium cocoyl methyl taurate;

the thickening agent is selected from one or more of cellulose and derivatives thereof, guar gum, sodium alginate, xanthan gum, guar gum hydroxypropyl trimethyl ammonium chloride, carrageenan or locust bean;

the sweetener is selected from one or more of saccharin sodium, sucralose, xylitol, sodium cyclamate, aspartame, stevioside or mogroside;

the essence is selected from one or more of vanilla essence, spearmint essence, mint essence or wintergreen mint essence;

the preservative is selected from one or more of benzoic acid and salts thereof, sorbic acid and salts thereof or parabens;

the appearance modifier is selected from one or more of titanium dioxide, food pigment, food color lake or tooth cleaning particle;

the solvent is selected from deionized water.

4. The oral care product according to claim 1 or 2, wherein the oral care product is a mouthwash, further comprising:

the humectant is selected from one or more of sorbitol, propylene glycol, glycerol and polyethylene glycol-8;

the surfactant is selected from one or more of poloxamer 407, sodium lauryl sulfate, sodium lauroyl sarcosinate and sodium cocoyl methyl taurate;

the thickening agent is selected from one or more of cellulose, carbomer and carrageenan;

the edible essence is selected from one or more of flos Caryophylli, cortex Cinnamomi, flos Osmanthi Fragrantis, oleum Menthae Dementholatum, herb Hierochloes Adoratae essence, herba Menthae Rotundifoliae, herba Menthae Haplocalycis, and herba Menthae Dementholati;

the colorant is selected from one or more of green, blue and red.

5. A method of making an oral care product according to claim 3, comprising:

A. dissolving cortex Phellodendri bark extract, fructus Lycopersici Esculenti fruit extract, tea tree essential oil, and azulene sodium sulfonate in humectant, stirring at high speed to obtain first mixed solution;

B. adding a thickening agent into the first mixed solution, and stirring to obtain a second mixed solution;

C. adding an appearance modifier into the second mixed solution, and stirring to obtain a third mixed solution;

D. adding the third mixed solution, the sweetening agent, the friction agent, the essence, the foaming agent and the preservative into the solvent, and stirring to obtain a fourth mixed solution;

E. continuously stirring the fourth mixed solution under the vacuum condition of 0.08-0.12MPa to prepare paste;

F. checking, aseptically filling into aluminum plastic composite tube, sealing, and making into toothpaste.