CN113520962A

CN113520962A - Composition for oral ecological care and preparation method and application thereof

Info

Publication number: CN113520962A
Application number: CN202110676686.6A
Authority: CN
Inventors: 戴开金
Original assignee: Guangdong Southern Medical University Technology Exploitation Co ltd; Southern Medical University
Current assignee: Guangdong Southern Medical University Technology Exploitation Co ltd; Southern Medical University
Priority date: 2021-06-18
Filing date: 2021-06-18
Publication date: 2021-10-22

Abstract

The invention provides a composition for oral ecological care, which comprises a traditional Chinese medicine extraction mixture, zanthoxylum oil and a solubilizer; the traditional Chinese medicine extraction mixture is a mixture of an extract of the plant of Chinese dwarf lilyturf, an extract of honeysuckle, an extract of weeping forsythia, an extract of green tea, an extract of mulberry leaf and an extract of dendrobium officinale; the addition amount of the zanthoxylum piperitum oil is 0.01-0.02% of the total mass of the Chinese medicinal extract mixture; the addition amount of the solubilizer is 0.03-0.05% of the traditional Chinese medicine extraction mixture. The invention also comprises a preparation method and application of the composition. The invention surprisingly discovers that a proper amount of zanthoxylum piperitum oil is added into the traditional Chinese medicine extraction mixture, so that a better oral care effect can be realized, and the oral care mixture has the effects of preventing gingival bleeding and oral ulcer, improving oral peculiar smell, preventing moth, fixing teeth, protecting gum, reducing tooth sensitivity and the like. The Chinese medicine extract mixture and the zanthoxylum oil have a synergistic effect, have a strong inhibition effect on helicobacter pylori, and can effectively relieve and treat the oral ulcer disease.

Description

Composition for oral ecological care and preparation method and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a composition for oral ecological care and a preparation method and application thereof.

Background

Oral diseases, including periodontitis, periodontal abscess, gingival bleeding, oral ulcers and halitosis, are caused by a number of pathogenic bacteria in the oral cavity. The results of the research show that up to 97% of adults in recent years are suffering from varying degrees of oral problems. The oral care product can obviously reduce pathogenic bacteria in the oral cavity, effectively sterilize and stop bleeding, eliminate halitosis and protect the oral health, thereby preventing bacteria and toxin from invading blood and achieving the purpose of preventing diseases. The existing gargle in the market mostly takes chlorine dioxide, chlorhexidine acetate, metronidazole and tetracycline as main functional components, and although the gargle has obvious sterilization effect, the gargle as a chemical product has adverse effect on beneficial flora in human body while sterilizing.

The human oral cavity is one of the important places where microorganisms inhabit, and the oral microbial community is one of the most complex microbial communities of the human body and is composed of more than 700 microorganisms. Common oral diseases of human beings are closely related to oral microorganisms, such as Porphyromonas gingivalis and periodontitis, Streptococcus mutans, Lactobacillus, and dental caries. Once imbalanced, oral microorganisms not only cause oral disease, but may even cause systemic disease. Therefore, inhibiting the growth and reproduction of oral bacteria and maintaining the balance of oral microorganisms are important measures for preventing oral diseases. The oral pathogenic bacteria are the usual bacteria in human oral cavity, and various microorganisms form certain physiological combination in type and quantity in a healthy state. When the flora is disordered, a certain strong pathogen can excessively multiply to cause diseases. After long-term use of broad-spectrum antibiotics and chemical synthetic drugs, the pathogenic bacteria are eliminated, and simultaneously the microbial balance of the oral cavity is destroyed, so that various oral inflammations are initiated or aggravated. Therefore, these oral care products cannot be used as daily products, and should be stopped when complications of oral tissues are cured, so as not to cause imbalance of normal flora in the oral cavity and to develop drug tolerance. It is of great interest to develop agents that control, rather than destroy, pathogenic bacteria or eliminate specific pathogenic mechanisms.

Helicobacter pylori is a bacterium that is helicoidal, micro-anaerobic, and has very strict requirements for growth conditions. Helicobacter pylori lives in the pylorus region of the human stomach and is one of the most common bacterial pathogens. Most of the world's population is infected with H.pylori, and in some countries almost 90% of people are infected with this bacterium. If helicobacter pylori is infected, the phenomena of bad breath and aggravation of halitosis can be easily caused. Because helicobacter pylori produces uricase in our stomach, this material decomposes into amines, and when the ammonia gas in the body is excessive, it is exhaled out of the body through our mouth, resulting in the occurrence of halitosis. In the prior art, the method of adding Chinese herbal medicines into toothpaste is mostly adopted to inhibit bacteria in the oral cavity and protect teeth, but helicobacter pylori can not be inhibited.

The natural Chinese herbal medicines contain a lot of active ingredients, so that the effect is obvious and the traditional Chinese medicine is safer for human bodies, and the active ingredients of the traditional Chinese medicines are added into oral care products, so that a safer and green solution is provided for the oral problems. Therefore, with the gradually strengthened oral care consciousness of human, various Chinese herbal medicine oral products with remarkable efficacy and small side effect are prepared.

Disclosure of Invention

The disclosure may be understood more readily by reference to the following detailed description of preferred embodiments of the invention and the examples included therein. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In case of conflict, the present specification, including definitions, will control.

The term "prepared from …" as used herein is synonymous with "including". As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having," "contains," "containing," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.

The conjunction "consisting of …" excludes any unspecified elements, steps or components. If used in a claim, the phrase will render the claim closed except for the materials described, except for the conventional impurities associated therewith. When the phrase "consisting of …" appears in a clause of the subject matter of the claims rather than immediately after the subject matter, it defines only the elements described in the clause; other elements are not excluded from the claims as a whole.

When an amount, concentration, or other value or parameter is expressed as a range, preferred range, or as a range of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether ranges are separately disclosed. For example, when a range of "1 to 5" is disclosed, the described range should be interpreted to include the ranges "1 to 4", "1 to 3", "1 to 2 and 4 to 5", "1 to 3 and 5", and the like. When a range of values is described herein, unless otherwise stated, the range is intended to include the endpoints thereof and all integers and fractions within the range.

The singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. "optional" or "any" means that the subsequently described event or events may or may not occur, and that the description includes instances where the event occurs and instances where it does not.

Approximating language, as used herein in the specification and claims, is intended to modify a quantity, such that the invention is not limited to the specific quantity, but includes portions that are literally received by modifying or otherwise modifying such quantity without substantially changing the basic function to which it is related. Accordingly, the use of "about" to modify a numerical value means that the invention is not limited to the precise value. In some instances, the approximating language may correspond to the precision of an instrument for measuring the value. In the present description and claims, range limitations may be combined and/or interchanged, including all sub-ranges contained therein if not otherwise stated.

In addition, the indefinite articles "a" and "an" preceding an element or component of the invention are not intended to limit the number requirement (i.e., the number of occurrences) of the element or component. Thus, "a" or "an" should be read to include one or at least one, and the singular form of an element or component also includes the plural unless the stated number clearly indicates that the singular form is intended.

The invention provides a composition for oral ecological care in a first aspect, which comprises a traditional Chinese medicine extraction mixture, zanthoxylum oil and a solubilizer; the traditional Chinese medicine extraction mixture is a mixture of an extract of the plant of Chinese dwarf lilyturf, an extract of honeysuckle, an extract of weeping forsythia, an extract of green tea, an extract of mulberry leaf and an extract of dendrobium officinale; the addition amount of the zanthoxylum piperitum oil is 0.01-0.02% of the total mass of the Chinese medicinal extract mixture; the addition amount of the solubilizer is 0.03-0.05% of the traditional Chinese medicine extraction mixture.

In one or more embodiments, the addition amount of each component in the traditional Chinese medicine extraction mixture is as follows by weight: 10-15 parts of an extract of the Chinese ilex, 10-15 parts of an extract of honeysuckle, 12-17 parts of an extract of forsythia, 12-18 parts of an extract of green tea, 10-15 parts of an extract of mulberry leaves and 12-17 parts of an extract of dendrobium officinale.

In one or more embodiments, the zanthoxylum schinifolium oil comprises a vegetable oil component; the vegetable oil is salad oil, rapeseed oil, peanut oil, soybean oil or other edible vegetable oil.

In one or more embodiments, the solubilizing agent is one or both of PEG-40 hydrogenated castor oil, poloxamer 407, ethanol.

In a second aspect, the invention provides a process for the preparation of said composition, comprising the steps of:

(1) mixing the traditional Chinese medicines in parts by weight, crushing, taking water or an ethanol water solution as an extraction solvent, extracting by soaking, decocting, percolating, ultrasonically treating or refluxing, concentrating an extracting solution, adding ethanol to precipitate polysaccharide and tannin, collecting filtrate, and further concentrating the filtrate to obtain a traditional Chinese medicine extract;

preferably, the medicinal materials are crushed into micron to nanometer, 10-15 times of the medicinal materials and 30-50% of ethanol water solution are adopted for low-temperature vacuum extraction for 1-3 times, each time lasts for 1-2 hours, the filtration is carried out, the filtrate is combined, and the low-temperature vacuum concentration and drying are carried out on the filtrate to obtain the traditional Chinese medicine extract;

(2) and (3) selecting nonpolar or weak-polarity macroporous resin to separate and purify the traditional Chinese medicine extract: loading the traditional Chinese medicine extract into a purified macroporous resin column, wherein the loading amount is 4-12% of the mass of the dry resin, and after adsorption balance, eluting the traditional Chinese medicine extract with water until the traditional Chinese medicine extract is colorless; then eluting the extract by using ethanol water solution with the volume of 30 to 50 percent until the extract is colorless to obtain a refined traditional Chinese medicine extract;

(3) adding 10 times of water by mass into the traditional Chinese medicine extract in the step (2), uniformly stirring, then dripping zanthoxylum oil, and adding a solubilizer; and continuously stirring uniformly to obtain the composition for oral ecological care.

In a third aspect, the invention provides the use of said composition for inhibiting helicobacter pylori.

In a fourth aspect, the invention provides the use of the composition in the manufacture of an oral care product.

In one or more embodiments, the oral care product is a toothpaste, mouthwash, mouthspray, or chewing gum.

In one or more embodiments, the composition is added in an amount of 5% to 20% by weight of the total oral care product.

In a fifth aspect, the present invention provides a mouthwash comprising as an active ingredient a composition according to the invention. In particular, the ingredients of the mouthwash may or may not be added with auxiliary additives known in the art, such as sweeteners, antioxidants, and the like.

The traditional Chinese medicine extraction mixture provided by the invention has the following effects:

iron holly root: clear heat and remove toxicity, relieve swelling and alleviate pain. Can be used for treating common cold, tonsillitis, sore throat, acute gastroenteritis, and rheumatic osteodynia; it is used externally to treat traumatic injury, carbuncle, furuncle, sore, traumatic hemorrhage, burn and scald.

The honeysuckle extract is obtained by water extraction and alcohol precipitation of honeysuckle, has wide pharmacological effects, and mainly comprises anti-inflammatory, antipyretic, antibacterial, antiviral, antifungal, antiendotoxin, antihypertensive, liver-protecting and gallbladder-benefiting, antifertility, antioxidation, hemostasis, immunoregulation and the like. The honeysuckle plays roles of clearing heat and reducing internal heat, diminishing inflammation and relieving pain and removing halitosis in the toothpaste.

The effective components of the forsythia extract comprise benzodianthrone compounds: hypericin, pseudohypericin, protoporphyrin, cyclopseudohypericin, isohypericin, emodin-enone, hypericum-assisted dehydro-dianthrone, etc. The fructus forsythiae extract has antibacterial, antiviral, antiinflammatory, radiation injury resisting, and antipyretic effects, and has effects in treating cardiovascular diseases, capillary permeability and elastase activity inhibiting, antiemetic, liver injury resisting, hepatitis treating, heart strengthening, and diuretic effects. Fructus forsythiae is commonly used for treating acute wind-heat type common cold, carbuncle, swelling, sore, lymph node tuberculosis, urinary tract infection and other symptoms.

Green tea, polyphenol compounds separated and purified from the green tea, especially Tea Polyphenol (TP), is the main active component of tea, and has wide pharmacological action. The research proves that the tea polyphenol can inhibit GTF enzyme of bacteria, thereby inhibiting the growth and metabolism of various cariogenic bacteria such as streptococcus mutans, actinomyces viscosus, streptococcus salivarius and the like in the oral cavity, reducing the adhesion rate of the bacteria on the surface of teeth, having obvious anti-caries effect and no drug resistance.

The mulberry leaf extract has the functions of enhancing immunity, diminishing inflammation, inhibiting bacteria, resisting viruses, resisting blood coagulation, expanding blood vessels and the like, and has a stronger function of inhibiting common pathogenic bacteria in the oral cavity.

The dendrobium officinale polysaccharide has the functions of resisting bacteria, diminishing inflammation and enhancing the cellular immune activity, can inhibit the bacterial reproduction when being used in the oral cavity, and effectively prevents the peculiar smell of the oral cavity; the dendrobium officinale polysaccharide can stop bleeding when being externally used, and can promote the growth of fibrin, thereby promoting wound healing and repairing damaged oral tissues. The dendrobium officinale contains amino acid and various trace elements beneficial to human bodies, and the contained water-soluble polysaccharide is an immunopotentiator which can improve leucocytes and promote lymphocytes to generate lymphokines, so that the humoral immunity function and the cellular immunity function of an organism are enhanced, the autoimmunity of the organism is enhanced, and the recovery is promoted. The traditional Chinese medicine theory considers that the dendrobium officinale is slightly cold in nature and is a yin-nourishing holy product, and aphtha, ulcer, gum swelling and pain and the like are mostly caused by yin deficiency and fire excess, so the dendrobium officinale can be used for treating the oral problems.

Compared with the prior art, the invention has the advantages that:

the invention surprisingly discovers that a proper amount of zanthoxylum oil is added into the traditional Chinese medicine extraction mixture, so that a better oral care effect can be realized.

The Chinese medicine extract mixture and the zanthoxylum oil have a synergistic effect, have a strong inhibition effect on helicobacter pylori, and can effectively relieve and treat the oral ulcer disease.

The composition of the invention can inhibit oral disease microorganisms and maintain good ecology of the oral cavity; has the effects of preventing gingival bleeding and canker sore, improving oral peculiar smell, preventing moth, fixing teeth, protecting gum, reducing tooth sensitivity and the like, and has comprehensive functions; can be used for treating or preventing periodontal disease, oral mucosa disease, and dental caries.

Detailed Description

It is to be understood that within the scope of the present invention, the above-described technical features of the present invention and the technical features described in detail below (e.g., the embodiments) may be combined with each other to constitute a preferred embodiment.

In a fifth aspect, the present invention provides a mouthwash comprising as an active ingredient a composition according to the invention. In particular, the ingredients of the mouthwash further comprise auxiliary additives known in the art, such as sweeteners, antioxidants, and the like.

Example 1

A method for preparing a composition for oral ecology care comprising the steps of:

(1) preparing 1000g of immature tangerine peel, 1000g of honeysuckle, 1200g of fructus forsythiae, 1200g of green tea, 1000g of mulberry leaf and 1200g of dendrobium officinale, and mixing;

mixing the above Chinese medicinal materials, pulverizing, extracting with water or ethanol water solution as extraction solvent by soaking, decocting, percolating, ultrasonic extracting or refluxing, concentrating the extractive solution, adding ethanol to precipitate polysaccharide and tannin, collecting filtrate, and further concentrating the filtrate to obtain Chinese medicinal extract;

pulverizing the medicinal materials to micrometer-nanometer level, vacuum extracting with 10 times of medicinal materials and 30% ethanol water solution at low temperature for 1 time, each for 1 hr, filtering, mixing filtrates, and vacuum concentrating and drying the filtrate at low temperature to obtain Chinese medicinal extract;

(2) separating and purifying the traditional Chinese medicine extract by selecting HPD100 macroporous resin: loading the Chinese medicinal extract into purified macroporous resin column with loading amount of 4% of dry resin mass, and eluting with water to colorless after adsorption balance; then eluting with 30% ethanol water solution to colorless to obtain refined Chinese medicinal extract;

(3) adding 10 times of water into the Chinese medicinal extract mixture in the step (2), stirring, and dripping Zanthoxylum piperitum oilCommercially available oil of Yao Mazi Zanthoxylum piperitum) Adding a solubilizer; the addition amount of the zanthoxylum piperitum oil is 0.01% of the total mass of the Chinese medicinal extract mixture; the solubilizer is PEG-40 hydrogenated castor oil, and the addition amount of the solubilizer is 0.03 percent of the traditional Chinese medicine extraction mixture;

and continuously stirring uniformly to obtain the composition for oral ecological care.

Example 2

A method for preparing a composition for oral ecological care comprises the following steps:

(1) preparing 1500g of preserved szechuan lovage rhizome, 1500g of honeysuckle, 1700g of weeping forsythia, 1800g of green tea, 1500g of mulberry leaf and 1700g of dendrobium officinale, and mixing;

pulverizing the medicinal materials to micrometer-nanometer level, vacuum extracting with 15 times of medicinal materials and 50% ethanol water solution at low temperature for 3 times, each for 2 hr, filtering, mixing filtrates, and vacuum concentrating and drying the filtrate at low temperature to obtain Chinese medicinal extract;

(2) and (3) selecting nonpolar or weak-polarity macroporous resin to separate and purify the traditional Chinese medicine extract: loading the Chinese medicinal extract into purified macroporous resin column with loading amount of 12% of dry resin mass, and eluting with water to colorless after adsorption balance; eluting with 50% ethanol water solution to colorless to obtain refined Chinese medicinal extract;

(3) adding 10 times of water into the Chinese medicinal extract mixture in the step (2), stirring, and dripping Zanthoxylum piperitum oilCommercially available oil of Yao Mazi Zanthoxylum piperitum) Adding a solubilizer; the addition amount of the zanthoxylum piperitum oil is 0.02% of the total mass of the Chinese medicinal extract mixture; the solubilizer is PEG-40 hydrogenated castorA mixture of oil and poloxamer 407, and the addition amount of the oil is 0.05% of the traditional Chinese medicine extraction mixture;

Example 3

(1) preparing 1200g of preserved szechuan lovage rhizome, 1200g of honeysuckle, 1500g of weeping forsythia, 1500g of green tea, 1200g of mulberry leaf and 1500g of dendrobium officinale, and mixing;

pulverizing the medicinal materials to micrometer-nanometer level, vacuum extracting with 12 times of medicinal materials and 40% ethanol water solution at low temperature for 2 times, each for 1.5 hr, filtering, mixing filtrates, and vacuum concentrating and drying the filtrate at low temperature to obtain Chinese medicinal extract;

(2) and (3) selecting nonpolar or weak-polarity macroporous resin to separate and purify the traditional Chinese medicine extract: loading the Chinese medicinal extract into purified macroporous resin column with loading amount of 8% of dry resin mass, and eluting with water to colorless after adsorption balance; then eluting with 40% ethanol water solution to colorless to obtain refined Chinese medicinal extract;

(3) adding 10 times of water into the Chinese medicinal extract mixture in the step (2), stirring, and dripping Zanthoxylum piperitum oilCommercially available oil of Yao Mazi Zanthoxylum piperitum) Adding a solubilizer; the addition amount of the zanthoxylum piperitum oil is 0.015% of the total mass of the Chinese medicinal extraction mixture; the solubilizer is poloxamer 407, and the addition amount of the solubilizer is 0.04% of the traditional Chinese medicine extraction mixture;

Comparative example 1

A method of preparing a composition for oral ecological care comprising the same steps as in example 1, except that:

step (2) is omitted, and the traditional Chinese medicine extract is not further refined.

Comparative example 2

and (4) adding rattan pepper oil in the step (3).

Comparative example 3

the amount of the zanthoxylum piperitum oil added in the step (3) is 0.005% of the total mass of the Chinese medicinal extract mixture.

Comparative example 4

the amount of the zanthoxylum piperitum oil added in the step (3) is 0.04% of the total mass of the Chinese medicinal extract mixture.

Experiment on anti-gingivitis effect

The compositions obtained in examples 1 to 3 and comparative examples 1 to 4 were prepared as mouthwashes by adding purified water to each composition to make the composition 20% by weight.

Suitable subjects 80 were screened by examination of the subjects' soft and hard oral tissues, gingivitis and plaque, and randomized into experimental and control groups of 10 people each.

Experimental groups mouthwashes formulated with the compositions obtained in examples 1-3 and comparative examples 1-4; the formulation of the mouth wash used in the control group was the same as the mouth wash of example 1 except that the herbal extract mixture and zanthoxylum oil component of the composition of the present invention were not included.

The subjects were given the respective mouthwashes in a unified manner, and were asked to rinse 2 times a day (morning and evening) for 1min each time. It is required that no other oral hygiene products such as other kinds of toothpaste, toothbrush, mouthwash, dental floss, etc. are used during the experiment. There is no restriction on diet and smoking. At 6 weeks of use of the mouthwash, subjects were evaluated for plaque and gingivitis status following the procedure of the baseline examination.

Gingivitis index and test method (Loe-Silness):

gingivitis and gingival bleeding are measured using a gingivitis index test method, and the gingival condition is measured prior to measuring the plaque index. Gingivitis index counting methods and criteria are as follows:

0, the gingival margin and the gingival papilla are healthy in appearance, and bleeding does not occur after the gingival sulcus is slightly explored;

1, the gingival margin and the gingival papilla are healthy in appearance, and bleeding is caused after the gingival sulcus is probed lightly;

2, the gingiva is changed in color and luster due to inflammation, has no swelling or edema, and bleeds after probing (punctate bleeding);

3 ═ slight change in gum tone, edema, post-probe bleeding (bleeding spreading along the gingival margin);

4-gingival color change, marked edema, post-probe bleeding (bleeding over the gingival margin);

when the color of the gum changes, there is marked edema, sometimes ulceration, bleeding after probing or automatic bleeding.

Each buccal and lingual surface was examined and the maximum score for one tooth was 10. The mean of the gingival bleeding index is the sum of all the dental values (2 surfaces per tooth) divided by the total number of surfaces measured (2 teeth measured).

Plaque index and method of examination: supragingival plaque was assessed using the Quigley-Hein modified Turesky plaque index and recorded after staining with stain according to the following criteria:

0 ═ no plaque;

1, scattered bacterial plaque exists at the edge of the neck of the tooth;

2-a continuous thin band of plaque (up to 1mm wide) is visible at the edge of the tooth neck;

1/3 for bands of tooth neck plaque greater than 1mm but less than the tooth surface;

1/3-2/3 for plaque covering the tooth surface;

5-plaque covers above the tooth surface 2/3.

The buccal and lingual surfaces of each tooth were examined (maximum score of 10 per tooth). The mean of the plaque index for each subject was obtained by dividing the sum of the individual total dental examination counts (2 records per tooth) by the total number of measurements (number of teeth multiplied by 2).

TABLE 1 Baseline examination results for a population of subjects

Group of gargle	Number of people	Index of bacterial plaque	Index of gingivitis
				Example 1	10	3.15±0.52	1.53±0.38
Example 2	10	3.12±0.55	1.51±0.32
				Example 3	10	3.13±0.51	1.55±0.35
Comparative example 1	10	3.16±0.52	1.52±0.37
				Comparative example 2	10	3.15±0.54	1.57±0.38
Comparative example 3	10	3.12±0.55	1.55±0.34
				Comparative example 4	10	3.14±0.55	1.58±0.35
Control group	10	3.18±0.53	1.53±0.37

The test results are shown in table 2:

TABLE 2 Change in gingivitis and plaque indices in subjects after 6 weeks of experiment

Group of gargle	Number of people	Index of bacterial plaque	Index of gingivitis
				Example 1	10	2.25±0.46	1.11±0.32
Example 2	10	2.18±0.51	1.16±0.29
				Example 3	10	2.19±0.49	1.18±0.35
Comparative example 1	10	2.36±0.52	1.25±0.33
				Comparative example 2	10	2.88±0.51	1.55±0.32
Comparative example 3	10	2.79±0.49	1.48±0.33
				Comparative example 4	10	2.22±0.55	1.17±0.29
Control group	10	2.97±0.48	1.53±0.35

As can be seen from Table 2, the mouth rinses formulated with the compositions obtained in examples 1-3 are effective in reducing plaque and inhibiting gingivitis. Compared with examples 1-3, the effect of comparative example 4 is not much, but the zanthoxylum oil added in comparative example 4 is too much, and 10 subjects have bad experience, such as spicy feeling, peculiar smell in mouth after gargling and the like; while none of the other groups of subjects experienced a similar sensation in the gargling book. Therefore, the effect of oral care can be improved without bad experience only by adding the zanthoxylum schinifolium oil in the addition amount disclosed by the invention.

Helicobacter pylori bacteriostasis experiment

The compositions obtained in examples 1 to 3 and comparative examples 1 to 4 were prepared as mouthwashes by adding purified water to each composition to make each composition 15% by weight. The formulation of the mouth wash used in the control group was the same as the mouth wash of example 1 except that the composition of the present invention was not contained in the herbal extract mixture and the zanthoxylum oil component

In recent years, many scholars have found that helicobacter pylori is closely related to oral ulcer, and the relevance is also summarized in chinese patent CN 201310521843.1: helicobacter pylori is an important flora causing dental ulcer, and inhibition of helicobacter pylori is effective in alleviating the disease.

The antibacterial test of helicobacter pylori is carried out on the mouthwash of each group according to the evaluation method of antibacterial and bacteriostatic effects of QBT 2738 daily chemical products in the industry standard, and the test results are shown in Table 3.

TABLE 3 results of in vitro bacteriostatic experiments on H.pylori

As is clear from Table 3, examples 1 to 3, comparative example 1 and comparative example 4 all had a strong inhibitory effect on helicobacter pylori. Comparative example 2, in which zanthoxylum piperitum oil was not added, and comparative example 3, in which zanthoxylum piperitum oil was added too little, did not exhibit a good helicobacter pylori inhibitory effect. Therefore, the traditional Chinese medicine extract mixture and the zanthoxylum oil have a synergistic effect, have a strong inhibition effect on helicobacter pylori, and can effectively relieve and treat the oral ulcer disease.

Toothpaste formulations and efficacy testing

The compositions obtained in examples 1-3 and comparative examples 1-4 were formulated as toothpaste with the following formulation: 35% of glycerin, 10% of silicon dioxide, 70% of sorbitol, 35% of sodium lauryl sulfate, 1.5% of sodium carboxymethylcellulose, 0.3% of essence, 0.02% of erythritol sugar, 5% of the compositions of examples 1 to 3 and comparative examples 1 to 4, and the balance of pure water.

The above prepared toothpastes were subjected to clinical observation (each toothpaste was screened for 20 patients who met the symptoms × 4 groups), the test period was one month, and the test period was once a day after breakfast, lunch and supper. The oral disease status of the subjects before and after the experiment is observed, and the statistics of the results are shown in table 7 (the data in the table is the total effective rate).

Toothpaste group	Bleeding of gum	Periodontitis	Gingivitis	Oral ulcer	Dental caries
						Example 1	85.8％	88.2％	79.5％	82.6％	75.9％
Example 2	87.2％	86.5％	80.5％	83.3％	77.1％
						Example 3	84.9％	87.7％	81.3％	82.8％	77.5％
Comparative example 1	65.8％	66.7％	68.6％	68.9％	60.6％
						Comparative example 2	55.5％	54.7％	48.2％	56.1％	48.9％
Comparative example 3	70.8％	69.7％	72.6％	71.9％	62.6％
						Comparative example 4	72.8％	75.7％	73.5％	75.7％	65.8％

From the above clinical observation results, it can be seen that the toothpaste prepared by using the composition of the present invention has certain prevention and treatment significance on gingival bleeding, periodontitis, gingivitis, oral ulcer, dental caries, etc., and the efficacy of the examples is significantly better than the comparative examples.

The invention is not limited to the specific examples described above, and any person can be aware of the dosage or formulation given in the teaching of the invention and the variations obvious to those skilled in the art, and all technical solutions having the same or similar components as the present invention, are within the scope of the present invention.

Claims

1. A composition for oral ecological care comprises a Chinese medicinal extract mixture, Zanthoxylum oil and a solubilizer; the traditional Chinese medicine extraction mixture is a mixture of an extract of the plant of Chinese dwarf lilyturf, an extract of honeysuckle, an extract of weeping forsythia, an extract of green tea, an extract of mulberry leaf and an extract of dendrobium officinale; the addition amount of the zanthoxylum piperitum oil is 0.01-0.02% of the total mass of the Chinese medicinal extract mixture; the addition amount of the solubilizer is 0.03-0.05% of the traditional Chinese medicine extraction mixture.

2. The composition of claim 1, wherein the Chinese medicinal extract mixture comprises the following components in parts by weight: 10-15 parts of an extract of the Chinese ilex, 10-15 parts of an extract of honeysuckle, 12-17 parts of an extract of forsythia, 12-18 parts of an extract of green tea, 10-15 parts of an extract of mulberry leaves and 12-17 parts of an extract of dendrobium officinale.

3. The composition of claim 1, wherein the zanthoxylum piperitum oil comprises a vegetable oil component; the vegetable oil is salad oil, rapeseed oil, peanut oil, soybean oil or other edible vegetable oil.

4. The composition of claim 1, wherein the solubilizing agent is one or both of PEG-40 hydrogenated castor oil, poloxamer 407, and ethanol.

5. A process for the preparation of a composition according to any one of claims 1 to 4, characterized by the following steps:

6. Use of a composition according to any one of claims 1 to 4 or a composition obtainable by a process according to claim 5 for the inhibition of helicobacter pylori.

7. Use of a composition according to any one of claims 1 to 4 or a composition obtainable by a process according to claim 5 for the preparation of an oral care product.

8. The use of claim 7, wherein the oral care product is a toothpaste, a mouthwash, an oral spray, or a chewing gum.

9. The use of claim 7 or 8, wherein the composition is added in an amount of 5% to 20% by weight based on the total weight of the oral care product.

10. A mouthwash comprising as active ingredient a composition according to any one of claims 1 to 4 or obtained by the preparation process according to claim 5.