Throat care products and methods of making the same

Abstract

The present disclosure relates to the technical field of pharyngeal non-drug bactericidal and anti-inflammatory paste, and particularly relates to a pharyngeal care product for reducing the risk of repeated infection and mixed infection of helicobacter pylori and a preparation method thereof. The pharyngeal care product of the present disclosure comprises: a substrate; and an effective component dispersed in the substrate, wherein the effective component comprises, in terms of mass percentage, plant flavone with a purity greater than 27%, 15-30%; green salt, 2-10%; and xuanfuhua, 5-15%. The present disclosure can greatly reduce the probability of repeated infection and mixed infection of helicobacter pylori.

Description

Technical Field

[0001] This disclosure relates to the technical field of non-drug bactericidal and anti-inflammatory ointments for the pharynx, and in particular to a pharyngeal care product and its preparation method for reducing the risk of reinfection and mixed infection of Helicobacter pylori. Background Technology

[0002] Helicobacter pylori (H. pylori) is a Gram-negative, microaerophilic human pathogen that can cause various diseases, including chronic active gastritis, peptic ulcers, lymphoblastic lymphoma, and gastric adenocarcinoma. Previous H. pylori culture methods suffered from a significant delay between bacterial growth and colony formation, leading to the loss of different ST-type genes in both primary and subculture cultures. This affected the accuracy and consistency of antimicrobial susceptibility testing results, increasing the difficulty of developing anti-H. pylori products and compromising the reliability of their efficacy.

[0003] A single patient's gastrointestinal mucosa can be colonized by one or more *H. pylori* strains, termed a single infection or mixed infection. If a patient with a single or mixed infection is re-detected with the same genotype of *H. pylori* after recovery, it is called a reinfection. Because antimicrobial resistance can vary among different *H. pylori* isolates, mixed infections may lead to eradication therapy failure. Reinfected *H. pylori* strains exhibit enhanced resistance, also resulting in eradication therapy failure. The prevalence of mixed *H. pylori* infections varies significantly between urban and rural areas (0%–100%). RAPD (DNA fingerprinting) technology cannot determine the evolutionary relationship between different *H. pylori* isolates from an individual host, thus failing to identify cases of *H. pylori* reinfection. However, using the colony suspension dilution method to obtain individual colonies from primary cultures, combined with multiple sequence typing (MLST) technology, to determine the evolutionary relationship between *H. pylori* isolates, can clearly identify whether a patient has a single, mixed, or reinfection, providing a basis for precise clinical treatment.

[0004] In their clinical practice, doctors have observed a significant increase in patients with ulcerative colitis and Helicobacter pylori pharyngitis after using triple therapy to eradicate Helicobacter pylori. Furthermore, traditional triple therapy often results in drug resistance, reinfection, and mixed infections, leading to a high prevalence of H. pylori.

[0005] Public content I. Technical problems to be solved This disclosure aims to at least partially solve one of the aforementioned technical problems.

[0006] II. Technical Solution This disclosure provides a throat care product that reduces the risk of reinfection and mixed infection with Helicobacter pylori.

[0007] The second aspect of this disclosure provides a method for preparing a pharyngeal care product that reduces the risk of reinfection and mixed infection with Helicobacter pylori.

[0008] III. Beneficial Effects As can be seen from the above technical solution, this disclosure has at least one of the following beneficial effects compared to the prior art: (1) Reduce the chance of repeated and mixed infections of Helicobacter pylori.

[0009] (2) Reduce some of the side effects caused by triple or quadruple therapy.

[0010] (3) It has a significant effect on improving the cure rate of triple or quadruple drug therapy. Attached Figure Description

[0011] Figure 1 Comparison of Helicobacter pylori eradication rates detected by carbon respiration assay.

[0012] Figure 2 Comparison of Helicobacter pylori eradication rates detected by culture method.

[0013] Figure 3 The pre-production preparation process for the throat care toothpaste of this embodiment.

[0014] Figure 4 The production process for preparing the pharyngeal care toothpaste of this embodiment is described below. Detailed Implementation

[0015] Helicobacter pylori pharyngitis is a disease that occurs and is named by doctors after eradicating Helicobacter pylori in the stomach using triple or quadruple therapy, and it has become a common and frequently occurring disease.

[0016] After extensive independent research, the applicant discovered that Helicobacter pylori differs from other intestinal bacteria. First, it does not rely on symbiotic relationships with other intestinal bacteria for survival; it can create its own environment through its own enzymes. Second, it multiplies and lyses in different locations through its motility; once a colony is formed, the bacteria within can divide into new colonies in other parts of the body using flagellar motility. Third, it can escape to various parts of the body, including blood vessels. When suppressed by drugs, it can either ascend to the pharynx to hide or descend to the colon to hide, causing new diseases. Fourth, it is a morphologically variable bacterium, capable of transforming into different forms depending on nutritional and environmental conditions.

[0017] Most importantly, during drug eradication therapy, Helicobacter pylori can migrate upwards to the pharynx and remain dormant. Residual Helicobacter pylori in the pharynx is a major cause of recurrent infections, recurrent gastrointestinal diseases, and reduced efficacy of eradication therapy. Furthermore, the applicant, through gene comparison of residual Helicobacter pylori in the pharynx with drug-resistant Helicobacter pylori in the stomach, discovered their homology. Therefore, eradicating residual Helicobacter pylori in the pharynx is not only necessary for treating Helicobacter pylori pharyngitis but also for eradicating Helicobacter pylori. All studies indicate that drug treatment alone cannot completely eliminate residual Helicobacter pylori in the pharynx, which is the key reason why the goal of truly eradicating Helicobacter pylori cannot be achieved clinically. Therefore, eradicating Helicobacter pylori residing in the pharynx due to fecal-oral or gastro-oral infections to improve the effectiveness of triple or quadruple therapy and the eradication rate of Helicobacter pylori is the main problem this disclosure aims to solve.

[0018] The applicant discovered through culture experiments and high-throughput gene sequencing that the number of Helicobacter pylori in pharyngeal samples differed significantly between day and night. Culture experiments also confirmed a significant difference in colony count and positivity rate (viability), indicating that the timing of colony formation is the cause of the difference; colonies are more likely to form at night. Combined with clinical symptoms, this confirms a clear correlation between the diurnal variation in Helicobacter pylori pharyngitis symptoms and colony formation, i.e., the number of Helicobacter pylori.

[0019] Based on the applicant's research and findings on Helicobacter pylori, this disclosure utilizes the effective components of agricultural crops (soy isoflavones), Inula japonica (traditional Chinese medicine), hematite (traditional Chinese medicine mineral), and chitosan, and takes into account the diurnal variation of Helicobacter pylori colonies in the human body, to produce a non-pharmaceutical antibacterial and anti-inflammatory preparation that can be used day and night, enhance the pharyngeal mucosa's resistance function, and simultaneously have antibacterial and anti-inflammatory effects.

[0020] Example 1 To make the objectives, technical solutions, and advantages of this disclosure clearer, the following detailed description is provided in conjunction with specific embodiments and the accompanying drawings.

[0021] Accordingly, the applicant designed two toothpastes, one for daytime and one for nighttime, with different active ingredients and different acid-suppressing effects during the day and night. Given that stomach acid secretion is higher between 3 and 4 AM, the applicant's toothpaste design fully considers the difference in stomach acid secretion levels between day and night and the different effects of stomach acid secretion on patients' symptoms throughout the day and night, incorporating active ingredients with acid-suppressing effects. Compared to other toothpastes with only one design, the applicant's toothpaste, through its unique daytime and nighttime design, can achieve precise management throughout the day, providing the simultaneous effects of fresh breath, Helicobacter pylori removal, and acid suppression that other toothpastes cannot achieve.

[0022] Furthermore, the toothpaste of this embodiment not only inhibits and kills Helicobacter pylori present in the oral cavity and pharynx, but also serves as an adjunct to drug eradication therapy for Helicobacter pylori, helping to improve the eradication rate. This is the biggest difference between this embodiment and other brands of toothpaste. The inhibition and killing of Helicobacter pylori residing in the pharynx in this embodiment is to prevent the development of drug resistance and recurrent Helicobacter pylori infection; other functional toothpastes only inhibit and kill Helicobacter pylori that enters the body through the mouth, but the Helicobacter pylori remaining in the pharynx has no biological activity. This different understanding of the biological characteristics and pathogenic mechanism of Helicobacter pylori is the reason why the toothpaste of this embodiment has a different research and development perspective and design concept than other functional toothpastes.

[0023] In this disclosure, the daily-use product inhibits and kills Helicobacter pylori in the pharynx, freshens breath, and is suitable for daytime activities. The daily-use product is used after waking up in the morning or after meals, and its ingredients include: a base material and a daily-use active ingredient; the daily-use active ingredient is used to inhibit the adhesion and aggregation of Helicobacter pylori in the pharynx under conditions of frequent pharyngeal activity during the day, and to improve the cleanliness and freshness of the pharynx.

[0024] The active ingredients in this daily-use product are: soy isoflavones, sage, peppermint oil, inula japonica, peppermint oil, and chitosan. The mass percentages of each ingredient in the total daily-use product are as follows: plant flavonoids, 15-30%; sage, 2-10%; inula japonica, 5-15%; peppermint oil, 1-2%; chitosan, 0.1%-3%; and lactoferrin, with a mass percentage content of 0.05%-1%.

[0025] In a preferred embodiment of this disclosure, the formulation of the daily-use toothpaste is shown in Table 1.

[0026] Table 1. Formulation of the One-Day Use Toothpaste in Examples Daily use: In this disclosure, the nighttime version targets the increased gastric acid secretion and easier formation of Helicobacter pylori colonies at night. The active ingredients in the nighttime version work by creating a relatively stable pharyngeal microenvironment under conditions of reduced pharyngeal activity at night, inhibiting the recolonization of Helicobacter pylori in the pharynx and reducing its migration to the stomach. The nighttime version is used before bedtime or after dinner. It also contains ingredients such as ochre to enhance its function of inhibiting gastric acid reflux and disrupting the colony-forming environment, while the fragrance helps promote sleep.

[0027] In this disclosure, the composition of the night-use product includes: a base material and night-use active ingredients; the active ingredients of the night-use product are: ochre, inula japonica, sage, and soybean isoflavones. The night-use active ingredients include the following materials in weight percentage: plant flavonoids, 15-30%; sage, 2-10%; inula japonica, 5-15%; ochre powder, 15-25%.

[0028] In a preferred embodiment of this disclosure, the formulation of the night-use toothpaste is shown in Table 2.

[0029] Table 2. Formulation of overnight toothpaste in the example The following is a detailed description of the toothpaste used in this embodiment to reduce the risk of reinfection and mixed infection of Helicobacter pylori.

[0030] I. Plant Flavonoids The applicant's research indicates that the purity of plant flavonoids significantly affects their antibacterial activity. Experimental data shows that when the purity of plant flavonoids is below 27%, the effect is weak and cannot effectively inhibit the growth of Helicobacter pylori. However, when the purity of plant flavonoids is greater than or equal to 42%, they have a significant bactericidal effect on Helicobacter pylori, while purity between 27% and 42% mainly plays a role in inhibiting growth. This difference in purity is based on the patented technology proposed in this invention and verified by in vitro antibacterial experiments. The specific experimental methods and results are as follows: Experimental methods: The inhibitory effect of plant flavonoids of different purities on Helicobacter pylori was detected by the standard microdilution method.

[0031] Experimental results: When the purity of plant flavonoids was below 27%, they failed to effectively inhibit the growth of Helicobacter pylori; when the purity of plant flavonoids reached above 42%, the antibacterial effect was significantly improved.

[0032] However, in the overnight version, if the purity of soy isoflavones is too high, the high purity of the isoflavones, when continuously present in the overnight environment, will enhance other biological activities of soy isoflavones, such as inhibiting protein tyrosine kinases. Therefore, the applicant designed the purity of soy isoflavones in the overnight version to be between 27% and 35%, thereby maintaining the normal microecological balance of the pharynx while inhibiting the growth of Helicobacter pylori.

[0033] Inner Mongolia is one of the major soybean producing areas in my country, so the main ingredient of the toothpaste in this embodiment is soybean isoflavone extracted from Inner Mongolian soybeans. The main components of soybean isoflavone are daidzin, genistin, and gycitin. Furthermore, it should be noted that the soybean isoflavone used in this disclosure can be replaced by other plant flavonoids, such as broad bean isoflavone and kudzu root isoflavone.

[0034] II. Salt The applicant's research found that salinity can alter the morphology and number of Helicobacter pylori flagella. Increased salinity reduces the number of flagella and may even lead to the appearance of hard flagella. Salt can reduce the adhesion of Helicobacter pylori flagella to the pharyngeal epithelium, causing them to detach from the pharyngeal epithelium and migrate to the stomach where drug concentrations are higher, where they are killed by the drug. This ensures that the drug eradicates Helicobacter pylori without leaving any blind spots.

[0035] The applicant's research found that using rock salt to alter the morphology of Helicobacter pylori, by reducing its flagella and changing its shape, can decrease the adhesiveness of Helicobacter pylori. Rock salt is recorded in ancient books such as the "Compendium of Materia Medica" as having the effects of clearing heat, strengthening teeth, and stopping bleeding. Rock salt can treat periodontitis and gingivitis, and can also eliminate halitosis.

[0036] Compared to other toothpastes that directly add materials to kill Helicobacter pylori, this disclosure uses special ingredients to alter the morphology of Helicobacter pylori. It does not solely emphasize antagonistic sterilization, but rather changes the living environment of Helicobacter pylori through the active ingredients in the toothpaste, causing its biological morphology to change, such as into a coccus, short bacillus, or stalked bacillus, thus causing it to lose its flagella, thereby losing its adhesiveness and pathogenicity. While eliminating Helicobacter pylori, it can also effectively reduce the risk of drug resistance.

[0037] III. Ochre When ochre is made into an ultrafine powder, it contains catalase, which can inhibit and kill Helicobacter pylori. The applicant discovered through high-throughput gene sequencing that the number of Helicobacter pylori in pharyngeal samples differed significantly between day and night. Culture experiments also confirmed a significant difference in colony count and survival rate, indicating that the timing of colony formation is the cause of the difference; colonies are more likely to form at night. Combined with clinical symptoms, this confirms a clear correlation between the diurnal variation in Helicobacter pylori pharyngitis symptoms and the formation of colonies, i.e., the number of Helicobacter pylori.

[0038] Acid reflux is one of the side effects of medication-based Helicobacter pylori eradication programs. The reason for this is that stomach pain caused by acid reflux after Helicobacter pylori infection is more pronounced during the day, especially before and after meals. At night, the main symptom is acid reflux, usually around 3-4 AM. Besides medication-induced endocrine disorders, nighttime acid reflux is also related to the fact that Helicobacter pylori colonies are more likely to form at night. Therefore, the toothpaste in this embodiment is designed to fully consider the differences in gastric acid secretion between day and night and the different effects of gastric acid secretion on patients' symptoms throughout the day and night. It incorporates effective acid-suppressing ingredients, thereby effectively reducing the risk of reinfection and mixed infections of Helicobacter pylori. Other toothpastes generally do not consider acid-suppressing effects.

[0039] Ochre's dual function of sterilization and acid suppression, along with its role as a high-quality abrasive, represents a significant innovation. Ochre is an aqueous iron mineral; its ferric oxide powder particles possess a large specific surface area and a significant surface effect, making it an excellent catalyst in itself. The applicant's research revealed that ochre powder exhibits catalase-like effects, inhibiting the growth of Helicobacter pylori by altering the pharyngeal environment and directly participating in its eradication. Ochre particles have a hexahedral structure and excellent mechanical properties, with a relative density of 5-5.25 g / cm³. Unadulterated hematite has an optical band gap of 1.8-2.3 eV and very low electrical conductivity, making it an excellent material for dental polishing abrasives.

[0040] Compared to simply using rice flour as an abrasive, the mineral hematite combines the functions of grinding and inhibiting Helicobacter pylori. In traditional Chinese medicine, hematite is indeed used to relieve heartburn symptoms. Hematite is a mineral-based Chinese medicine with the effects of calming the liver and suppressing yang, and is often used to treat symptoms such as heartburn and acid reflux caused by liver-stomach disharmony. Its cold and descending properties help neutralize stomach acid and reduce the burning sensation in the stomach.

[0041] The combination of ochre and rice flour as an abrasive provides a more efficient cleaning effect compared to other toothpastes that only use rice flour, and can also relieve swollen and bleeding gums. Using ochre and rice flour as an abrasive ensures the toothpaste ingredients are edible and safe for humans, while further enhancing the abrasive effect. Ochre itself can effectively neutralize acid, and its catalase function can eliminate Helicobacter pylori, and it also has a good effect on preventing swollen and bleeding gums. This breaks the traditional limitations of toothpaste where "abrasives" only perform cleaning functions and "active ingredients" only perform biological functions. By selecting a combination of minerals with ideal physical properties and specific biological activities with other edible ingredients, this toothpaste is more effective and safer than other toothpastes with only one abrasive and one function.

[0042] Based on the above, the abrasive used in the nighttime version of the throat care product in this embodiment is made of rice flour and ochre powder (3000 mesh). At the same time, in order to alleviate the bitter taste of ochre powder, honey-processed Inula japonica is used for neutralization, as it can mask the bitterness of ochre.

[0043] It is important to note that ochre powder is not used in the daily-use version. Ochre powder is a high-density mineral powder with numerous polar hydroxyl sites and a microporous structure on its surface. Upon entering the saliva system, it can bind and retain isoflavone active molecules in soy isoflavones through hydrogen bonding, coordination, and capillary adsorption, transforming the rapid release process dominated by "dissolution-diffusion" into a slow-release process dominated by "adsorption-desorption." For high-purity soy isoflavones, their killing effect depends on reaching a high instantaneous effective concentration within a short period. However, the adsorption and retention of ochre powder reduces the initial dissolution rate, weakens the peak concentration, and prolongs the peak duration. This makes the active molecules more easily diluted and carried away under conditions of high saliva flow and frequent swallowing during the day, thus affecting the rapid killing of the target in the daily-use version. Therefore, ochre powder is not used as an abrasive in the daily-use version.

[0044] IV. Honey-processed Inula japonica Honey-processed Inula japonica has the effects of clearing heat and detoxifying, relieving nausea and asthma, and can treat symptoms such as sore throat. It also has hemostatic properties. Adding honey-processed Inula japonica not only removes the astringent taste of ochre but also enhances the treatment effect of Helicobacter pylori-induced pharyngitis and improves the taste of toothpaste. This is why the applicant dared to choose ochre as an abrasive. Furthermore, Inula japonica petals have a dual-scale structure composed of micron-sized papillae and nano-sized folds, belonging to the petal effect surface, which has high adhesion properties and superhydrophobic properties, making it easier to form a multiphase dispersed network structure with other components.

[0045] V. Chitosan and lactoferrin In the pharyngeal care composition disclosed herein, chitosan and lactoferrin participate in the system construction as structural regulating components. Chitosan is preferably chitosan powder with a degree of deacetylation of not less than 80% and an average molecular weight of 50,000 to 300,000 Daltons. The particle size of chitosan in the system is preferably less than 50 μm, more preferably 10 to 30 μm, to facilitate its uniform dispersion and film-forming continuity in the aqueous system.

[0046] Lactoferrin is preferably food-grade lactoferrin powder, with a particle size preferably not greater than 100 μm, more preferably 20–80 μm. Lactoferrin exists in a finely dispersed state in the composition, forming a stable dispersed phase unit with plant flavonoids.

[0047] Plant flavonoids are preferably in powder form, with ultrafine powders prepared by an ultrasound-assisted antisolvent method exhibiting higher bioavailability and stronger water solubility. The particle size is preferably no greater than 200 μm, and more preferably 20–100 μm. Controlling the particle size of plant flavonoids helps them to distribute evenly within the chitosan network structure and reduces sedimentation.

[0048] The ochre powder is preferably a high-mesh mineral powder without impurities, with a particle size of not less than 2000 mesh, preferably 2000-3000 mesh. Higher mesh ochre powder has a larger specific surface area, which is beneficial for chitosan to form a uniform interface layer on its particle surface and embed into the three-dimensional network structure formed by chitosan.

[0049] Chitosan forms a continuous or semi-continuous three-dimensional film-forming network structure in the composition through shear dispersion and vacuum mixing processes. This network structure is distributed between plant flavonoid particles and mineral particles, forming a spatial support framework. The thickness of chitosan distribution on the surface of mineral particles is affected by its molecular weight and the shear conditions of the system. Within the particle size range, it can form a stable interface layer, thereby improving the dispersion uniformity of mineral particles in the system.

[0050] Lactoferrin and plant flavonoids form a co-dispersed state under the aforementioned particle size control conditions. Since the particle sizes of plant flavonoids and lactoferrin are at similar dispersion scales, they can form a uniform embedded distribution within the chitosan network structure, thus constituting a multiphase dispersed network system. This system includes a continuous phase chitosan network, a dispersed phase of plant flavonoid and lactoferrin composite particles, and a filling phase of mineral particles.

[0051] Under the aforementioned particle size and dispersion conditions, the apparent viscosity of the composition, measured by a rotational viscometer at 25°C, is 300,000–500,000 cP, making it suitable for use in pharyngeal care products. This high viscosity not only ensures the stability of the paste but also allows for the formation of a good adhesion layer on the pharyngeal surface, preventing the loss of active ingredients during swallowing. The viscosity range is set based on the film-forming structure and the need for active ingredient retention required by this invention. By adjusting the concentration and particle size of chitosan, the viscosity can be precisely controlled to ensure long-lasting release of the product in the pharynx.

[0052] Compared to systems with uncontrolled particle size or simple physical mixing, this disclosure achieves a hierarchical construction of a multiphase dispersion system by limiting the particle size range of plant flavonoids, lactoferrin, chitosan, and ochre powder, and combining this with the three-dimensional network structure formed by chitosan. This hierarchical structure is achieved through particle size matching, interface layer formation, and continuous network support, rather than a simple superposition of single components.

[0053] Furthermore, this disclosure achieves a structural synergistic effect of plant flavonoids, honey-processed Inula japonica, and ochre powder by introducing chitosan and lactoferrin, forming a novel throat care product. This product possesses a unique multiphase dispersed network structure and achieves sustained release and retention of the active ingredients through precise physical regulation.

[0054] VI. Other ingredients In addition to the above-mentioned active ingredients, the toothpaste in this embodiment contains the following: thickener: sodium carboxymethyl cellulose + soy isoflavones; humectant: glycerin; foaming agent: sodium lauroyl glutamate; sweetener: natural malt; antioxidant: tea polyphenols; flavoring: peppermint oil + clove oil; preservative: parabens. The content of each ingredient is shown in Tables 1 and 2.

[0055] The toothpaste described in this embodiment that reduces the risk of Helicobacter pylori reinfection and mixed infection differs from traditional products in the following aspects: 1. Target audience Clinically, even with quadruple therapy, 20% of patients still cannot be cured of Helicobacter pylori. Drug treatment alone cannot completely eradicate the Helicobacter pylori remaining in the pharynx, which is the key reason why the goal of truly eradicating Helicobacter pylori cannot be achieved in clinical practice.

[0056] The toothpaste in this embodiment is for use by confirmed infected individuals and those undergoing drug treatment, and also has preventative effects; essentially, it works in conjunction with drug treatment to kill any remaining Helicobacter pylori in the pharynx. Other functional toothpastes are for use by individuals preventing infection and those suspected of being infected.

[0057] 2. Mechanism of action The active ingredient in existing anti-Helicobacter pylori toothpastes inhibits and kills Helicobacter pylori strains.

[0058] The active ingredients in this toothpaste do not solely emphasize antagonistic bactericidal action. Instead, they alter the living environment of Helicobacter pylori, changing its morphology. For example, using chlorine salt transforms it into cocci, short bacilli, or stalked bacteria, causing it to lose its flagella, thus losing its adhesiveness and pathogenicity, and allowing it to be expelled from the body. It also prevents and destroys the colony formation of Helicobacter pylori residing in the pharynx at night. Furthermore, in the nighttime version, high-purity plant flavonoids are used to kill Helicobacter pylori, while in the daytime version, appropriately pure plant flavonoids maintain an environment that inhibits the growth of Helicobacter pylori.

[0059] 3. Prevention and control routes and usage methods Other existing functional toothpastes for Helicobacter pylori use the fecal-oral and oral-oral infection pathways, while the applicant's toothpaste primarily uses the gastro-oral infection pathway.

[0060] In this embodiment, the active ingredient of the toothpaste acts on the pharynx inside the mouth, while the active ingredient of other functional toothpastes acts on the area around the teeth. In this embodiment, it is recommended that users tilt their heads back and rinse their mouths while brushing their teeth with toothpaste.

[0061] This product differs from traditional functional toothpaste in that it effectively kills Helicobacter pylori that remains in the pharynx due to fecal-oral or gastro-oral infections. Helicobacter pylori is an anaerobic bacterium, and what is detected in the oral cavity are spherical, inactive, or dead Helicobacter pylori bacteria. Traditional functional toothpastes only act on the oral cavity, merely cleaning it, and are ineffective in killing Helicobacter pylori.

[0062] Compared to other toothpastes that only act on the oral cavity, the applicant's toothpaste has a deeper and more unique target area, resulting in a stronger effect. During drug eradication therapy, Helicobacter pylori can ascend to the pharynx and hide there. The applicant's toothpaste works by clearing away the hidden Helicobacter pylori in the pharynx, thereby improving the effectiveness of triple or quadruple therapy and the eradication rate of Helicobacter pylori. Combined with rinsing, it effectively clears Helicobacter pylori remaining in the pharynx, cleaning the oral cavity and pharynx while simultaneously supporting medication treatment.

[0063] Figure 1 The figure shows a comparison of Helicobacter pylori eradication rates detected by the carbon respiration assay. As shown in the figure, compared to the triple method alone, the Helicobacter pylori eradication rate of the triple method plus the toothpaste of this embodiment increased from 68% to 80.95%. Compared to the quadruple method alone, the Helicobacter pylori eradication rate of the quadruple method plus the toothpaste of this embodiment increased from 82% to 95.23%.

[0064] Figure 2 The figure shows a comparison of Helicobacter pylori eradication rates detected by the culture method. As shown in the figure, compared to the triple method alone, the Helicobacter pylori eradication rate of the triple method plus the toothpaste of this example increased from 68% to 85.71%. Compared to the quadruple method alone, the Helicobacter pylori eradication rate of the quadruple method plus the toothpaste of this example increased from 82% to 95.23%.

[0065] It is evident that both the carbon respiration assay and the culture assay significantly improved the eradication rate of Helicobacter pylori.

[0066] The following describes the equipment required to prepare the toothpaste described above that reduces the risk of Helicobacter pylori reinfection and mixed infection.

[0067] 1. 100L and 120L mixers 2. 265L Vacuum Emulsifier 3. 1300L Vacuum Emulsifier 4. 2500L Vacuum Kneader 5. Automatic filling machine 6. Automatic cartoning machine 7. Rotary capping machine Figure 3The pre-production preparation workflow for the throat care toothpaste of this embodiment is shown in the figure. The pre-production preparation workflow includes: A1, Preparation of honey-processed Inula japonica Add 25 jin of refined honey to every 100 jin of Inula japonica flowers, then add a little boiling water and stir until slightly thickened. Stir-fry over low heat until yellow and no longer sticky. Remove and let cool completely before use. Based on a total production volume of 1000 kg per batch, and a 5% loss due to materials such as hanging on the wall, the total amount of honey-processed Inula japonica flowers to be prepared for each production should be 105 kg.

[0068] It should be noted that honey-processed Inula japonica can be stored. If it is prepared continuously at a ratio of 25 catties of refined honey to 100 catties of Inula japonica, there is no need to consider the loss due to sticking to the bottle.

[0069] A2, Preparation of Thickeners Thickeners can be made using one of the following two methods: The first method: Add 6.5 kg of sodium carboxymethyl cellulose 3000 to 60 kg of water in a 120L mixer at a speed greater than 260 rpm to form 0.1 μm particles. Add 1.5 kg of sodium carboxymethyl cellulose 1500 to 15 kg of water in a 120L mixer at a speed greater than 260 rpm to form 0.1 μm particles. Mix the sodium carboxymethyl cellulose 3000 and sodium carboxymethyl cellulose 1500 together and continue mixing with a No. 91 rotor at a speed of 0.6 rpm to prevent sedimentation and clumping until before adding glycerin.

[0070] The second method: Add 100 kg of glycerin to a 120L mixer at a speed greater than 260 rpm. Add sodium carboxymethyl cellulose (CMC) 3000 and 1500 slowly, following the principles of small, dispersed, even addition to prevent clumping. Wait until the CMC 3000 and 1500 have settled into the glycerin before adding more. After all the CMC 3000 and 1500 have been added, continue mixing for 10 minutes. Do not stop mixing until the mixture is pumped to a 1300L vacuum emulsifier.

[0071] It is particularly important to emphasize that it is strictly forbidden to pour the prepared sodium carboxymethyl cellulose 3000 and sodium carboxymethyl cellulose 1500 into glycerin at the same time.

[0072] A3, Preparation of Fragrances The equipment used is a 100L capacity mixer.

[0073] Turn on the heating element of the mixer and maintain the temperature between 40°C and 55°C. Pour 1 kg of clove oil and 3.5 kg of tea polyphenols into the 100L mixer and mix for 5 minutes until homogeneous. Add 15.5 kg of peppermint oil and mix for 30 minutes until completely dissolved. The mixing speed should be ≥100 rpm. The preparation of the spices should be carried out simultaneously with starting the 2500L vacuum kneader.

[0074] After the material preparation is completed, the production process of the pharyngeal care toothpaste in this embodiment is started.

[0075] Figure 4 The manufacturing process for preparing the pharyngeal care toothpaste of this embodiment is shown in the figure. The manufacturing process for the pharyngeal care toothpaste of this embodiment includes: S1, initial emulsification Water-based raw materials are processed in a 265L vacuum emulsifier.

[0076] Take 100 kg of water, add 5.5 kg of malt, 100 kg of honey-processed Inula japonica, and 50 kg of sodium lauroyl glutamate. After the vacuum degree reaches above -650 mmHg, start stirring until the raw materials are completely dissolved. The emulsification / stirring speed should be ≥1000 rpm / 100 rpm, the emulsification / stirring time should be ≥10 minutes, and the scraper speed should be ≥40 rpm. It should be noted that the vacuum machine must be running continuously before the raw materials in the 265L vacuum emulsifier are transferred to the 1300L emulsifier.

[0077] S2, add water-based raw materials After rinsing the pipes of the 265L vacuum emulsifier with the remaining water, pump it into the 1300L vacuum emulsifier. Once the vacuum value reaches above -650mmHg, stir for 5 minutes.

[0078] Step S3, add thickener Thickener (glycerol and sodium carboxymethyl cellulose raw materials) is added to a 120L mixer and then pumped into a 1300L vacuum emulsifier, with stirring throughout the process. The emulsification / stirring speed must be ≥1800rpm / 30rpm, the emulsification / stirring time must be ≥30 minutes, the scraper speed must be ≥30rpm, and the vacuum degree must be ≥-650mmHg. Vacuum operation is required throughout the entire process.

[0079] Step S4, add antibacterial ingredients The raw materials were pumped from the 1300L vacuum emulsifier into the 2500L vacuum kneader. 220 kg of soybean isoflavones, 10 kg of chitosan, and 1 kg of lactoferrin were poured into the 2500L vacuum kneader through a feeding funnel. The vacuum machine was turned on, and after the vacuum value reached -650 mmHg, the mixture was stirred for 30 minutes.

[0080] Step S5: Add abrasive and acid inhibitor. When producing daily-use products, add 250kg of rice flour to a vacuum kneader.

[0081] When producing the nighttime toothpaste, 50 kg of rice flour and 200 kg of ochre powder are added. The vacuum machine is turned on, and after the vacuum value reaches -650 mmHg, stirring is started for 30 minutes.

[0082] Step S6, add antibacterial ingredients After mixing is complete, turn off the vacuum machine and feed the material again. Add 40 kg of green salt into the 2500 vacuum kneader through the feeding funnel, and mix for 30 minutes after the vacuum value reaches -650 mmHg.

[0083] Step S7, add spices The spice mixture in the 100L mixer is added into the 2500 vacuum kneader through the feeding funnel. After the vacuum value reaches -650mmHg, it is stirred for 30 minutes.

[0084] Step S8, Sample Detection After kneading, the colloid is sampled and sent for testing. The tests include paste viscosity, stability, pH value, and hardness index. Viscosity must be ≥500,000 cP. If the test is passed, the paste is pumped into a tank truck and then pumped into the filling machine's hopper for filling according to specifications and settings. If the test fails, the paste is returned to the factory or disposed of.

[0085] This concludes the description of this embodiment.

[0086] It should be noted that Example 1 provides the pharyngeal care product and its preparation method for mass production. However, in the laboratory stage, the applicant conducted rigorous experiments on the various material components and their proportions of the pharyngeal care product. The comparative results show that both methods can significantly reduce the probability of Helicobacter pylori reinfection.

[0087] Example 2: In Example 2, the active ingredients of the daytime and nighttime versions of the throat care product are shown in Table 3. The daytime toothpaste mainly adjusted the proportions of honey-processed Inula japonica, rock salt, soy isoflavones, and chitosan. The increased amount of honey-processed Inula japonica and rock salt is mainly because they have their own medicinal effects. 1) To improve symptoms such as sore throat, bleeding gums, loose teeth, and halitosis during the day. 2) Utilizing the dual-scale structure composed of micron-sized papillae and nano-sized folds of Inula japonica petals, together with ultrafine powdered soy isoflavones and chitosan prepared by ultrasound-assisted antisolvent method, a multiphase dispersion network structure with both high adhesion and superhydrophobic properties is formed to better protect the pharyngeal epithelial tissue and inhibit the growth of Helicobacter pylori in the pharynx.

[0088] To produce 1000 kg of daily-use toothpaste, you will need 300 kg of rice flour, 150 kg of honey-processed Inula japonica, 100 kg of rock salt, 150 kg of soy isoflavones, and 5 kg of chitosan. The emulsification process remains unchanged, as do the contents and weights of other ingredients.

[0089] Table 3. Formulation of the active ingredients in the throat care toothpaste in Example 2 The formula of the night-use toothpaste has been adjusted by adding ochre and lactoferrin. The main purpose is to inhibit and kill Helicobacter pylori, while preventing its colony formation and reducing nighttime acid reflux symptoms. Ochre powder is firstly an abrasive, a high-mesh mineral powder without impurities, with a particle size of not less than 2000 mesh, preferably 2000-3000 mesh. Secondly, ochre powder is also a bioactive substance. In addition to having a catalase-like effect, the higher mesh size of ochre powder provides a larger specific surface area, which facilitates the formation of a uniform interfacial layer of chitosan on its particle surface and embedding it into the three-dimensional network structure formed by chitosan, thereby improving the antibacterial efficacy.

[0090] The nighttime version, based on a production volume of 1000 kg, requires 50 kg of rice flour, 50 kg of honey-processed Inula japonica, 250 kg of ochre powder, 100 kg of rock salt, 150 kg of soybean isoflavones, 5 kg of chitosan, and 10 kg of lactoferrin. The emulsification process remains unchanged, as do the content and weight of other ingredients.

[0091] Example 2 demonstrates that adjusting the active ingredient can achieve the same effect of protecting the pharynx and inhibiting Helicobacter pylori.

[0092] Example 3: In Example 3, the active ingredients of the daytime and nighttime versions of the throat care product are shown in Table 4.

[0093] In Table 4, for daily-use toothpaste produced in a quantity of 1000 kg, chitosan is increased to 30 kg, rice flour to 200 kg, honey-processed Inula japonica to 150 kg, rock salt to 20 kg, and soy isoflavones to 300 kg. The emulsification process remains unchanged, and the content and weight of other ingredients remain the same.

[0094] Table 4. Formulation of the active ingredients in the throat care toothpaste in Example 3 Table 4 shows that, for the nighttime toothpaste produced in a quantity of 1000 kg, chitosan is increased to 30 kg, rice flour to 50 kg, honey-processed Inula japonica to 150 kg, rock salt to 20 kg, and soy isoflavones to 300 kg. Ochre and lactoferrin are added; 150 kg of ochre and 10 kg of lactoferrin are required. The emulsification process remains unchanged, and the content and weight of other ingredients remain the same.

[0095] Example 3 demonstrates the importance of the dispersed phase network structure and emphasizes the role of chitosan. In addition to direct antagonistic treatments, the eradication of Helicobacter pylori should utilize multi-pathway, multi-target, and multi-level mechanisms of action. This naturally complements and synergizes with anti-Helicobacter pylori treatment regimens that primarily focus on etiological treatment.

[0096] It should be noted that the above embodiments are illustrated using toothpaste as an example. However, those skilled in the art should understand that the formulation used in this disclosure is not particularly limited: such as being formulated as chewing gum, mouthwash, syrup, or powder. These variations contain the same active ingredient as those in this embodiment, differing only in the matrix. Regarding the matrix components of chewing gum, mouthwash, syrup, powder, etc., please refer to the descriptions in the relevant prior art; they will not be repeated here.

[0097] This concludes the description of the various embodiments of this disclosure. Based on the above description, those skilled in the art should have a clear understanding of this disclosure.

[0098] It should be noted that for some implementation methods, if they are not key contents of this disclosure and are well known to those skilled in the art, they are not described in detail in the accompanying drawings or text due to space limitations. In such cases, relevant prior art can be referred to for understanding.

[0099] Unless explicitly stated otherwise, the numerical values ​​and ranges mentioned in this disclosure are approximate and can be changed according to the content of this disclosure. Specifically, all figures in the specification and claims indicating composition, reaction conditions, etc., should be understood to be modified by the term "about" in all cases, meaning that they include variations of ±10% in certain embodiments.

[0100] Those skilled in the art will understand that in the claims and specification of this disclosure, the word "comprising" does not exclude the presence of elements (or steps) not listed in the claims. The word "a" or "an" preceding an element (or step) does not exclude the presence of a plurality of such elements (or steps).

[0101] Furthermore, the above embodiments are provided only to enable this disclosure to meet legal requirements, and this disclosure may be implemented in many different forms and should not be construed as limited to the embodiments set forth herein.

[0102] Similarly, it should be understood that, for the sake of brevity, in the foregoing description of exemplary embodiments of this disclosure, various features of this disclosure are sometimes grouped together in a single embodiment, figure, or description thereof. However, this approach to disclosure should not be construed as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as reflected in the claims, each aspect of the disclosure comprises fewer than all the features of the preceding single embodiment. Furthermore, embodiments may be used in combination with each other or with other embodiments based on design and reliability considerations; that is, technical features from different embodiments can be freely combined to form more embodiments. Therefore, the claims following the detailed description are hereby expressly incorporated into that detailed description, wherein each claim itself is a separate embodiment of this disclosure.

[0103] The above specific embodiments have provided a detailed description of the purpose, technical means, and beneficial effects of this disclosure. It should be understood that the purpose of the detailed description is to enable those skilled in the art to understand this disclosure more clearly, and it is not intended to limit this disclosure. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this disclosure should be included within the protection scope of this disclosure.

Claims

1. A throat care product for reducing the risk of reinfection and mixed infection with Helicobacter pylori, characterized in that, This throat care product includes: Substrate; The active ingredients dispersed in the substrate, by mass percentage, include: plant flavonoids, 15-30%; chlorite, 2-10%; Inula japonica, 5-15%; chitosan, 0.1-3%, wherein the purity of the plant flavonoids is greater than 27%.

2. The throat care product according to claim 1, characterized in that, The throat care products are available in daytime and nighttime versions; The daytime and nighttime versions can be used together; Both the daytime and nighttime versions include: a base material and active ingredients; The active ingredient in the daily-use product is used to kill Helicobacter pylori in the pharynx; The active ingredient in the nighttime version is designed to provide a microenvironment that inhibits the recolonization and migration of Helicobacter pylori in the pharynx.

3. The throat care product according to claim 2, characterized in that, In the daily-use product, the purity of plant flavonoids is greater than or equal to 42%; the base material of the daily-use product includes: an abrasive, the mass percentage of which is 20-30%; In the night-use product, the purity of plant flavonoids is between 27% and 35%. The active ingredients of the night-use product include: ochre powder, with a mass percentage content of 15% to 25%, which also serves as an abrasive; the Inula japonica is honey-processed Inula japonica; the base material of the night-use product includes: an abrasive, with a mass percentage content of 2% to 10%.

4. The throat care product according to claim 3, characterized in that, In the daytime and nighttime versions, the abrasive is one or more of the following materials: rice flour, aluminum hydroxide, hydrated silica, calcium carbonate, and calcium hydrogen phosphate.

5. The throat care product according to claim 4, characterized in that, The active ingredients also include: lactoferrin 0.05%–1%; The lactoferrin, together with plant flavonoids, Inula japonica, and chitosan, constitutes a multiphase dispersed network structure; the apparent viscosity of the pharyngeal care composition measured by a rotational viscometer at 25°C is 300,000–500,000 cP; and the chitosan forms a continuous three-dimensional film-forming network structure in the substrate system.

6. The throat care product according to claim 5, characterized in that, The plant flavonoids mentioned include: daidzein, genistein, and daidzein; and / or, The plant flavonoids mentioned are one of the following: soybean flavonoids, broad bean flavonoids, kudzu root flavonoids, and yew flavonoids; and / or, The active ingredient in the night-use version, ochre powder, has a particle size of not less than 3000 mesh; the abrasive used in the base materials of both the day-use and night-use versions is rice flour, with a particle size of not less than 2000 mesh.

7. The throat care product according to claim 6, characterized in that, The active ingredient in both the daytime and nighttime versions is soy isoflavone. In the daytime version, the purity of soy isoflavone is 42%, and its mass percentage content is 22%. In the nighttime version, the purity of soy isoflavone is 27%, and its mass percentage content is 22%. In both the daytime and nighttime versions, the salt content is 4% by mass. In both the daytime and nighttime versions, the Inula japonica contains 10% by weight. In both the daytime and nighttime versions, the chitosan content is 1% by mass. In the base material of the daytime version, the abrasive is rice flour, which accounts for 25% of the total content; in the active ingredient of the nighttime version, ochre powder accounts for 20% of the total content. The base material of the night-use version also includes: rice flour, which accounts for 5% by weight; The active ingredients in the daily-use version also include: peppermint oil, 1-2%.

8. The throat care product according to claim 1, characterized in that, The throat care product is one of the following types: toothpaste, chewing gum, mouthwash, syrup, or powder.

9. The throat care product according to claim 8, characterized in that, The throat care product is toothpaste; The toothpaste requires the user to tilt their head back and rinse their mouth when using it. The base materials for both the daytime and nighttime versions include: wetting agents, foaming agents, thickeners, sweeteners, antioxidants, fragrances, and preservatives, among which: The wetting agent includes: glycerin, 5-10%, and / or... The thickener comprises: 0.1-1.5% sodium carboxymethyl cellulose (3000 mesh) and sodium carboxymethyl cellulose (1500 mesh); the plant flavonoids also serve as a thickener; and / or, The foaming agent comprises: sodium lauroyl glutamate, 2-7%; and / or, The sweetener comprises: natural malt, 0.2-1%; and / or, The antioxidants include: tea polyphenols, 0.2-0.5%; and / or, The spices include: peppermint oil and / or clove oil, 1-2%; and / or, The preservatives include: hydroxybenzoic acid esters.

10. A method for preparing a throat care product, characterized in that, The method for preparing the pharyngeal care product according to any one of claims 1 to 9 includes: preliminary material preparation and production process flow; Preliminary material preparation includes: A1, made by processing Inula japonica with refined honey; A2, a thickener made from sodium carboxymethyl cellulose; A3 is a flavoring made from clove oil, peppermint oil, and tea polyphenols. The production process includes: S1, initial emulsification Take water, add malt, honey-processed Inula japonica, and sodium lauroyl glutamate, put them into a vacuum emulsifier, and stir until the raw materials are completely dissolved; S2, add water-based raw materials The raw materials after initial emulsification are pumped into a vacuum emulsifier and stirred. Step S3, add thickener The thickener is drawn into a vacuum emulsifier and stirred under vacuum throughout the process. Step S4, add antibacterial ingredients The raw materials in the vacuum emulsifier are drawn into the vacuum kneader; plant flavonoids, chitosan and lactoferrin are added to the vacuum kneader and stirred under vacuum conditions; Step S5: Add abrasive and acid inhibitor. Add the grinding agent to the vacuum kneader and stir under vacuum conditions; rice flour is added when preparing the day-use version, and rice flour and ochre powder are added when preparing the night-use version. Step S6, add antibacterial ingredients Add salt to a vacuum kneader and stir under vacuum conditions; Step S7, add spices Add fragrance to a vacuum kneader and stir under vacuum conditions to obtain a paste; Step S8, Sample Detection After kneading, the colloid is sampled and sent for testing; after passing the test, the paste is transported to the filling equipment for filling.

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