A multifunctional oral health protective composition and a method of making the same

Abstract

The application discloses a multifunctional oral health protection composition and a preparation method thereof, and belongs to the technical field of oral health care. The composition is composed of a trinity of oral protection chewable tablets, oral special protection toothpaste and an external use acupoint hydrophilic gel cataplasm. The chewable tablets are long-acting bacteriostatic, caries-preventing and gum-protecting, and can maintain oral microecology; the toothpaste is deep-cleaning, instant bacteriostatic, enamel-protecting and pellicle-protecting; and the cataplasm is acupoint pasting, which dredges meridians and relieves redness, swelling and pain. The three components are synergistic, and form a whole-chain protection system of "cleaning-bacteriostasis-gum protection-repair-relief-regulation", and form a complete action closed loop. The composition can clean the oral cavity, prevent caries, protect gums, freshen breath, repair mucosa, relieve discomfort and regulate oral microecology. The application adopts original materials such as phyllanthus emblica which are homologous in food and medicine, and is suitable for children, adults, the elderly and sensitive groups. The process is stable, suitable for industrialized production, and applicable to daily oral care, sensitive maintenance, heat regulation and other whole-scene protection.

Description

Technical Field

[0001] This invention relates to the field of oral health care technology, specifically to a multifunctional oral health protection composition consisting of chewing tablets, toothpaste, and a topical hydrophilic gel patch, and its preparation method. Background Technology

[0002] Halitosis, oral ulcers, and swollen gums are common problems that seriously affect quality of life and may trigger systemic diseases. Therefore, developing safe, effective, all-encompassing, and multi-group-suitable oral protection agents is of great significance.

[0003] Existing oral care products have significant defects:

[0004] 1. Limited functionality and lack of collaborative protection;

[0005] 2. Antibacterial ingredients can easily disrupt the oral microecology, and long-term use can cause significant irritation;

[0006] 3. Poor population compatibility; the formula is uniform and cannot meet the differentiated needs of children, adults, the elderly, and sensitive groups.

[0007] 4. The dosage forms are fragmented and lack synergy, failing to form an integrated system of "cleansing, protection, conditioning, and soothing";

[0008] 5. Topical patch formulations are highly irritating, have poor breathability, and are not sufficiently targeted to acupoints.

[0009] This invention was completed based on the shortcomings of the prior art and the urgent needs in the field, filling a technological gap in the industry. Summary of the Invention

[0010] The purpose of this invention is to provide a multifunctional oral health protection composition, which consists of three parts: an oral cleaning component, an oral care component, and a topical acupoint patch component. These three components form a synergistic system. The oral cleaning component is a chewable tablet, the oral care component is toothpaste, and the topical acupoint patch component is a water-based gel patch. Through the synergistic effect of these three components, a complete oral protection system of "cleaning-antibacterial-gingival protection-repair-soothing-conditioning" is constructed, forming a complete closed-loop action to achieve multi-dimensional and comprehensive oral health protection. Another objective of this invention is to provide a method for preparing the above-mentioned multifunctional oral health protection composition. This method is stable, simple to operate, suitable for large-scale industrial production, and effectively retains the active ingredients in the composition, ensuring the stable performance of the composition's oral protection efficacy.

[0011] In response to the shortcomings of existing oral protection products, such as fragmented forms, single efficacy, and superficial solutions, most existing products are single dosage forms or simple physical combinations, which can only achieve local immediate cleaning, single care, or local soothing. They lack systematic design and unified compatibility logic, and cannot take into account cleaning, protection, conditioning and soothing. They are unable to address the core pathogenesis of oral "exogenous plaque irritation, local microecological imbalance, and stagnation of qi and blood in the meridians", and cannot form a closed-loop protective effect that addresses both the symptoms and the root cause.

[0012] Therefore, this invention targets the core pathogenesis of oral problems, employing a three-pronged dosage form combination and functional synergy of "oral administration + local cleaning + external acupoint application" to achieve a comprehensive effect of deep local cleaning, long-term oral protection, and targeted meridian soothing. Specifically, the oral protection chewable tablets, when chewed and held in the mouth, act on the oral mucosa and tooth surface for a long-lasting effect, achieving antibacterial, anti-caries, gingival protection, and maintenance of the oral microecology, thus strengthening the body's foundation; the oral protection toothpaste, through daily brushing, achieves deep cleaning, immediate antibacterial action, and enamel and gingival protection, cutting off exogenous plaque irritation; and the external water-based gel patch is precisely applied to meridian acupoints, targeting and soothing discomfort, clearing qi and blood, and reducing redness, swelling, and pain. These three components work synergistically, addressing both the symptoms and the root cause, forming an integrated three-dimensional protective network, fundamentally overcoming the limitations of existing technologies that rely on single pathways, single targets, and single effects.

[0013] This composition is suitable for people of all ages. The formulation and dosage can be finely adjusted according to children, adults, the elderly and people with oral sensitivities, making it applicable to a wide range of scenarios. The entire composition has a unified formulation, synergistic mechanism, and stable process, which can achieve standardized and industrialized production. It has high patent protection value and broad market application prospects.

[0014] I. Overview of the Technical Solution

[0015] This invention relates to a multifunctional oral health protection composition, comprising three components: oral protective chewable tablets, oral protective toothpaste, and a water-based gel poultice. The oral protective chewable tablets are for oral administration, providing long-lasting antibacterial effects, preventing tooth decay, protecting gums, and maintaining the oral microecology. The oral protective toothpaste is for external brushing, providing deep cleaning, immediate antibacterial effects, and protecting enamel and dental mucosa. The water-based gel poultice is applied to acupoints, clearing meridians, providing targeted relief, and alleviating redness, swelling, and pain. These three components are homologous, complementary in function, and work synergistically to address both the symptoms and the root cause of the problem.

[0016] The core of this composition lies in constructing a comprehensive oral health protection system encompassing "cleaning-antibacterial-gingival protection-repair-soothing-conditioning" through the scientific formulation, synergistic effects, and optimized process of its three components. This fundamentally addresses the pain points of existing technologies. The formulation uses medicinal and edible raw materials and natural herbal extracts as its core active ingredients, ensuring high safety and strong compatibility to meet the diverse oral protection needs of different populations. Furthermore, relying on a unified formulation logic and synergistic preparation process, it achieves complementary active ingredients, synergistic mechanisms of action, and stable and controllable quality, resulting in a synergistic effect of "1+1+1>3".

[0017] This invention optimizes the preparation process for each of the three dosage forms, effectively solving problems such as easy inactivation of active ingredients, cumbersome processes, and difficulty in large-scale production. It achieves process synergy and efficient mass production, reduces production costs, and has good industrialization value. Specifically, the chewable tablets adopt low-temperature drying and precise granulation processes to retain the active ingredients to the greatest extent; the toothpaste adopts a gentle emulsification and low-speed stirring process to ensure system stability and uniform composition; and the topical poultice adopts a sustained-release matrix and precise coating process to achieve targeted sustained release at acupoints, good adhesion, and gentle, non-irritating properties. Ultimately, a standardized, industrializable, stable, and controllable complete preparation system is formed.

[0018] II. Raw material ratios, compatibility design, safety descriptions, and innovation of specific dosage forms

[0019] The three components of this composition are all formulated with the core principles of being natural, mild, and safe. They utilize ingredients derived from both food and medicine sources, functional fruits, and natural herbal extracts, creating a synergistic and unified formula. Furthermore, each component is differentiated based on its functional positioning and usage scenarios to meet the oral protection needs of different populations, as detailed below:

[0020] 1. Oral protection chewable tablets

[0021] Core functions: long-lasting antibacterial, anti-caries and gum protection, maintenance of oral microecology, suitable for all age groups, dosage and taste can be adjusted according to individual differences, taking into account both safety and practicality, suitable for daily long-term oral chewing, and works in conjunction with special protective toothpaste and external water-based gel patches to provide all-scenario oral protection.

[0022] 1.1 Raw material components, proportions, and compatibility design of oral protection chewable tablets

[0023] This invention provides an oral protective chewable tablet, characterized in that its raw material components and weight ratios include: 5-10 parts of honeysuckle extract, 2-4 parts of magnolia bark extract, 1-2 parts of clove extract, 2-4 parts of licorice extract, 2-4 parts of peppermint extract, 20-30 parts of xylitol, 4-7 parts of monk fruit extract, 15-25 parts of maltodextrin, 10-15 parts of microcrystalline cellulose, and 1-2 parts of magnesium stearate.

[0024] The above-mentioned components use extracts derived from both food and medicine as the core active ingredients, balancing synergistic efficacy with dosage form compatibility. Scientifically designed in strict accordance with the traditional Chinese medicine principle of "principal, assistant, adjuvant, and guide" in formulation, it addresses the complex pathogenesis of oral health issues such as "exogenous plaque irritation, local microecological imbalance, stagnation of qi and blood in the meridians, and mucosal fragility," achieving multi-target synergistic protection through "antibacterial activity, caries prevention, gingival protection, fresh breath, and maintenance of oral microecology." Its core innovation lies in its rigorous formulation structure, which, while ensuring highly effective protection, systematically harmonizes the inherent properties of each ingredient (such as irritation, bitterness, and medicinal biases) and optimizes dosage form compatibility. This results in a product that combines high efficacy, safety, and excellent palatability, suitable for long-term daily chewing use by people of all ages. Furthermore, the dosage of each ingredient has been scientifically optimized to ensure efficacy while avoiding taste or safety issues caused by improper dosage. The specific formulation logic is as follows:

[0025] 1.1.1 Principal Herb (1 ingredient) - Core antibacterial and gingival-protecting agent

[0026] Honeysuckle extract (5-10 parts): Sweet and cold in nature, it enters the lung, heart, and stomach meridians, and is the principal ingredient in this formula. Its core efficacy lies in broad-spectrum antibacterial activity. The active substances it contains, such as chlorogenic acid, can effectively inhibit harmful oral bacteria such as Streptococcus mutans and Escherichia coli, reducing inflammation at its source and gently protecting the gums. It directly targets the core pain points of oral microecological imbalance and harmful bacterial growth, cutting off the root cause of tooth decay and gum discomfort. Simultaneously, it has heat-clearing and soothing effects, relieving mild gum redness and swelling. This constitutes the core system of this preparation: "antibacterial and gum-protecting, clearing external pathogens," which is the core innovation that distinguishes this invention from existing single-function oral care products. This dosage range has been optimized to ensure the core antibacterial and gum-protecting efficacy while avoiding the bitter taste that may result from excessive dosage, meeting the palatability requirements of chewable tablets.

[0027] 1.1.2 Assistant Herbs (2 herbs) - Synergistically prevent tooth decay and regulate gut flora

[0028] 1.1.2.1 Magnolia officinalis extract (2-4 parts): Bitter, pungent, and warm in nature, it enters the spleen, stomach, lung, and large intestine meridians, serving as an assistant herb. Its magnolol content can specifically inhibit the growth of cariogenic bacteria, reduce plaque adhesion, enhance anti-caries efficacy, and help regulate the oral microecological balance and alleviate bad breath, compensating for the limitations of the principal herb, which focuses on antibacterial activity but lacks specificity in caries prevention. This dosage aims to synergize with the principal herb to construct a dual protection of "antibacterial activity + caries prevention." Its mild medicinal properties avoid excessive irritation from excessive ingredients, and in synergy with honeysuckle extract, it strengthens the oral health defense line.

[0029] 1.1.2.2 Clove Extract (1-2 parts): It is pungent and warm in nature, and enters the spleen, stomach, lung, and kidney meridians, serving as an assistant herb. Its potent anti-caries component, eugenol, can further reduce the risk of tooth decay. It synergistically enhances the protective effect with honeysuckle and magnolia bark, while its mild pungent aroma helps freshen breath and alleviate oral odor. Given its rich flavor, a low dosage is used to ensure both anti-caries efficacy and a pleasant overall taste. Synergistically with honeysuckle and magnolia bark, it forms a three-dimensional protective system of "antibacterial-anti-caries-freshening," specifically addressing core oral health risks.

[0030] 1.1.3 Adjuvant herbs (2 herbs) - protect mucous membranes, harmonize medicinal properties, and improve sensory perception.

[0031] 1.1.3.1 Licorice Extract (2-4 parts): Sweet and neutral in nature, it enters the heart, lung, spleen, and stomach meridians, serving as an adjuvant. Its core functions are threefold: First, it protects the oral mucosa, mitigating the slight irritation of extracts such as honeysuckle (cold) and clove (pungent and warm), preventing damage to the delicate oral mucosa and enhancing product safety, especially beneficial for children and sensitive individuals; second, it harmonizes the properties of the entire formula, balancing the cold nature of honeysuckle with the warm nature of magnolia bark and clove, making the overall formula mild and preventing cold pathogens from harming the spleen and stomach, or excessive warmth from causing oral dryness, ensuring the preparation can be chewed and taken for extended periods; third, it improves the taste, alleviating the bitterness of the herbal ingredients and increasing acceptance across all age groups. Simultaneously, its gentle gum-protecting effect can assist the principal and assistant herbs, further strengthening the oral protection effect.

[0032] 1.1.3.2 Peppermint Extract (2-4 parts): Pungent and cool in nature, it enters the lung and liver meridians and serves as an adjuvant. Its main functions are to freshen breath, provide a cooling and comfortable sensation, alleviate bad breath, and improve the palatability of chewable tablets, especially suitable for the taste needs of teenagers and adults; it also helps to soothe mild gum discomfort, and works synergistically with the principal and assistant herbs to relieve oral inflammation. Its cooling properties can help balance the warming and drying properties of the other herbs in the formula. This dosage has been optimized to provide a refreshing taste while avoiding excessive cooling that could irritate the oral mucosa, achieving the formulation design goal of "synergistic unity of efficacy and taste".

[0033] 1.1.4 Drug delivery (Class 3) - Flavoring, shaping, guiding drug efficacy

[0034] To ensure the stable molding, effective release, and excellent taste of the above-mentioned active ingredients, the following excipients are specially formulated as "guide ingredients" to balance molding, flavoring, guiding drug efficacy, harmonizing taste, and ensuring dosage form compatibility:

[0035] 1.1.4.1 Core flavoring and anti-caries components:

[0036] 1.1.4.1.1 Xylitol (20-30 parts): Sweet and neutral in nature, it enters the spleen and stomach meridians. As the main sweetener and anti-caries ingredient, its functions include: firstly, guiding the medicinal effect directly to the oral mucosa and tooth surface, enhancing the antibacterial and anti-caries effects of the principal and assistant drugs, strengthening the enamel protection effect, and preventing the growth of cariogenic bacteria; secondly, providing sweetness and improving taste, preventing fermentation and acid production by cariogenic bacteria in the mouth, helping to protect tooth enamel, and replacing sucrose to avoid the risk of tooth decay; thirdly, assisting in shaping, working synergistically with other excipients to ensure the chewable tablets have a delicate texture and are easy to chew, achieving a unity of "efficacy, taste, and dosage form". Its usage accounts for the highest proportion, and this ratio takes into account the anti-caries effect, taste, and food safety, avoiding gastrointestinal discomfort that may be caused by excessive dosage.

[0037] 1.1.4.1.2 Monk fruit extract (4-7 parts): Sweet and cool in nature, it enters the lung and large intestine meridians. As an auxiliary sweetener, its mild sweetness can further neutralize the bitterness of the herbal extracts, and synergistically with xylitol to construct a sugar-free sweetness system, improving product acceptability; it also has a slight antibacterial effect, which can help the principal drug balance efficacy and taste. Its cooling nature also helps to balance the properties of the whole formula, and synergistically with licorice and peppermint to ensure the mildness of the medicinal properties. At the same time, it is suitable for the sweetness requirements of chewable tablets, avoiding the addition of artificial sweeteners and improving product safety.

[0038] 1.1.4.2 Molding and Processing Auxiliaries:

[0039] Maltodextrin (15-25 parts), microcrystalline cellulose (10-15 parts), and magnesium stearate (1-2 parts): These three components work synergistically as the adjuvant, guiding the uniform release of the drug's potency, ensuring the tablet's formability and disintegration, and allowing the active ingredients to disperse rapidly after chewing, fully acting on the oral mucosa and tooth surface to maximize protective efficacy. Simultaneously, maltodextrin, as the main filler and forming agent, provides the tablet matrix, improving tablet formability and adjusting the chewing texture, resulting in tablets with moderate hardness and easy chewing. Microcrystalline cellulose assists in forming and improves disintegration, ensuring that the active ingredients dissolve rapidly after chewing and act on the oral cavity. Magnesium stearate, as a lubricant, reduces the adhesion of raw materials during preparation, ensuring smooth tableting, preventing material adhesion, and not affecting the taste and efficacy of the chewable tablet. The synergistic effect of these three components ensures dosage form compatibility, supports the efficacy of the adjuvant ingredients, and ensures the product can be industrially produced, stored for a long time, and suited for daily use needs.

[0040] 1.2 Compatibility Summary, Safety Description, and Innovation

[0041] This invention achieves the following synergistic goals through the systematic combination of the above-mentioned "principal-minister-assistant-envoy" framework:

[0042] 1.2.1 Synergistic Efficacy: With honeysuckle (the principal ingredient) as the core for its broad-spectrum antibacterial and gingival protection, magnolia bark and clove (the assistant ingredients) as the enhanced targeted anticaries, licorice and peppermint (the adjuvant ingredients) as the support for mucosal protection and flavor harmony, and xylitol and monk fruit (the envoy ingredient) as the foundation for anticaries flavoring, together they form a multi-target, three-dimensional oral protection network.

[0043] 1.2.2 Mild medicinal properties: Through the neutralizing effect of licorice and the cooling effect of mint and monk fruit, the cold and warm properties of the medicinal materials in the formula are effectively balanced, making the whole formula mild and suitable for long-term chewing and use by people of all constitutions.

[0044] 1.2.3 Dosage Form and Safety Compatibility: The potential mild irritation of clove extract and the potential mucosal irritation of peppermint extract have been effectively mitigated through compatibility with licorice extract and strict dosage control. The potential gastrointestinal discomfort risk caused by xylitol has also been controlled by limiting its proportion to 20-30 parts and combining it with monk fruit extract. Therefore, this formula achieves multiple oral protection benefits while fully ensuring safety and comfort, making it suitable for the long-term chewing needs of people of all ages.

[0045] The core innovation of this invention lies in the deep integration of the traditional Chinese medicine concept of "principal, assistant, adjuvant, and guide" in formulation with the precise needs of modern oral care. Through specific ingredient combinations and scientifically optimized weight ratios, multiple oral protection effects are achieved while cleverly harmonizing the "biases" of each ingredient (such as irritation, bitterness, or excessive cold or heat in medicinal properties). The result is an oral protection chewable tablet that is highly effective, safe, palatable, and technologically feasible. Unlike existing technologies that simply add ingredients or use formulations without theoretical guidance, this invention strictly adheres to traditional Chinese medicine theory and meets the actual needs of oral protection, highlighting its creativity and practicality.

[0046] 1.3 Differentiated Adjustments (Specific Refinements for Different Groups)

[0047] This chewable tablet has undergone precise ingredient ratio adjustments to ensure suitability for different groups, taking into account their oral physiological characteristics, taste preferences, and key protective needs. The specific adjustment plan is as follows:

[0048] 1.3.1 Children's Formula (Suitable for children aged 2-6): The core adjustment principle is to "reduce the amount of cooling ingredients, increase the amount of licorice and xylitol, make it gentle and easy to swallow, with a sweet and soft taste, primarily for preventing tooth decay, and with low irritation." Specific formula adjustments include: 5-7 parts honeysuckle extract (reduced dosage to minimize irritation), 2-3 parts magnolia bark extract (gentle tooth decay prevention), 1-1.2 parts clove extract (very low dosage to avoid taste irritation), 3-4 parts licorice extract (increased dosage to strengthen mucous membrane protection and improve taste), and peppermint extract. Extract 2-2.5 parts (reduced dosage to avoid excessive cooling sensation that irritates the mouth), xylitol 25-30 parts (increased sweetener dosage to improve palatability), monk fruit extract 6-7 parts (increased natural sweetness to harmonize the taste), maltodextrin 20-25 parts (increased filler content to improve tablet softness and chewability for young children), microcrystalline cellulose 10-12 parts (reduced dosage to make tablets more easily disintegrate and avoid swallowing risks), magnesium stearate 1-1.2 parts (low dosage to ensure proper tablet formation without affecting taste). Additional optimizations: Any potentially irritating impurities are removed; raw materials are pulverized to a finer mesh (120 mesh or finer) to ensure delicate particles that avoid scratching the delicate oral mucosa of children. The overall taste is mild and sweet, without bitterness, suitable for children's swallowing habits, and poses no safety risks even if small amounts are swallowed.

[0049] 1.3.2 6-12 year old school children's version: Suitable for primary school children whose oral development is not yet mature, with a high incidence of tooth decay, and who have problems such as picky eating and incomplete oral cleaning. At the same time, children prefer sweet and mild tastes and reject bitter or overly cool tastes. Therefore, the taste optimization focuses on "sweet and mild, no bitterness, and low coolness". The core adjustment principle is "mild antibacterial, enhanced anti-caries, and a sweet, fruity aroma." Specific adjustments include: 6-8 parts honeysuckle extract (mild antibacterial, reducing oral inflammation; low-temperature purification process removes bitter impurities); 2.5-3.5 parts magnolia bark extract (enhanced anti-caries; microencapsulation is used to mask its bitterness, addressing the high incidence of tooth decay in school-aged children); 1.2-1.5 parts clove extract (moderate dosage, balancing anti-caries and palatability; microencapsulation also weakens its strong medicinal taste); 2.5-3.5 parts licorice extract (protects the mucous membrane, harmonizes the taste, alleviates bad breath caused by picky eating, and enhances the sweetness); and 2.5-3 parts peppermint extract (using lemon-mint extract for a milder cooling sensation). This product contains: 24-28 parts xylitol (moderate sweetness, improves palatability while preventing tooth decay, combined with a small amount of maltitol (2-3 parts) to increase the sweetness and avoid the cloying feeling of a single sweetness); 5-6 parts monk fruit extract (natural sweetness, harmonizes the taste and avoids bitterness, while adding 1-2 parts jujube powder to enhance the mild and sweet taste, which is in line with children's preferences); 18-22 parts maltodextrin (moderate filling amount to ensure tablet hardness and easy for children to chew, using low DE value maltodextrin for a more delicate taste and no roughness); 11-13 parts microcrystalline cellulose (moderate amount to ensure disintegration and no risk of swallowing); and 1.2-1.5 parts magnesium stearate (moderate dosage to ensure shaping and taste). Additional optimizations: The flavor is sweet and mild, completely mitigating the cooling and stimulating taste of mint and the bitterness of herbal extracts. The raw materials are ground to a finer mesh (120 mesh or finer) to ensure a delicate texture suitable for the chewing strength of school-aged children. At the same time, the synergistic effect of anti-caries ingredients is enhanced to address the problem of excessive sugar intake in daily diets. 0.5 to 1 part of natural lemon flavoring (food grade) can be added to further improve palatability. No artificial colors or sweeteners are added to ensure safety and gentleness.

[0050] 1.3.3 13-18 year old teenagers: Suitable for teenagers in puberty, whose oral development is approaching maturity, but tooth decay is still common, and they are prone to mild gum redness and swelling, bad breath (due to hormonal changes, staying up late, and irregular diet). Teenagers prefer refreshing, non-greasy, and somewhat cooling tastes, and dislike strong medicinal tastes and overly sweet tastes. Therefore, the taste optimization focuses on "refreshing and non-greasy, mild and cooling, and no medicinal taste". The core adjustment principles are "refreshing and antibacterial, gum-protecting, and low-sweetness." Specific adjustments include: 7-9 parts honeysuckle extract (strengthened antibacterial properties, relieves mild gum redness and swelling, low-temperature purification removes bitterness and impurities); 3-4 parts magnolia bark extract (powerful anti-caries effect, reduces plaque buildup, microencapsulation masks bitterness); 1.4-1.8 parts clove extract (appropriately increased dosage enhances anti-caries efficacy, microencapsulation weakens the medicinal flavor, preventing a strong odor from affecting the taste); 2-3 parts licorice extract (protects the mucosa, soothes irritation, harmonizes the overall taste, avoids excessive cooling); and 3-3.5 parts peppermint extract (spearmint extract is selected, providing a refreshing and non-irritating cooling sensation, replacing the spiciness of traditional peppermint). Add 0.3-0.5 parts of menthol (food grade) to enhance fresh breath while avoiding a pungent, cooling sensation; 22-26 parts of xylitol (moderate sweetness, avoiding excessive sweetness, suitable for the taste preferences of teenagers; combined with 1-2 parts of erythritol to increase the refreshing taste and reduce cloying sweetness); 4-5 parts of monk fruit extract (mild sweetness, harmonizing the taste and avoiding bitterness; moderate amount, without increasing cloying sweetness); 17-21 parts of maltodextrin (moderate amount, using maltodextrin with medium DE value, smooth taste, no residue after chewing); 12-14 parts of microcrystalline cellulose (moderate amount, ensuring tablet hardness and disintegration, no roughness when chewing); and 1.3-1.7 parts of magnesium stearate (moderate dosage). Additional optimizations: The taste is moderately cool and refreshing without being greasy, with no obvious bitterness or medicinal taste, making it suitable for teenagers' daily carrying and chewing needs. At the same time, it enhances the antibacterial and gum-protecting effects to address oral health issues during puberty. 0.3 to 0.5 parts of natural peppermint flavoring (food grade) can be added to enhance the refreshing taste and cater to teenagers' preferences. All added ingredients are food grade and do not affect the product's safety and core efficacy, complying with patent regulations.

[0051] 1.3.4 Adult Formula (Suitable for adults aged 18-59): Utilizing a core basic formula, no additional adjustments are required. Specific proportions: 7-9 parts honeysuckle extract, 3-4 parts magnolia bark extract, 1.2-1.8 parts clove extract, 2-3 parts licorice extract, 3-4 parts peppermint extract, 22-28 parts xylitol, 5-6 parts monk fruit extract, 17-23 parts maltodextrin, 11-14 parts microcrystalline cellulose, and 1.2-1.8 parts magnesium stearate. This formula offers multiple benefits including antibacterial properties, cavity prevention, gum protection, and breath freshening, meeting the daily oral hygiene needs of adults. It has a cool and moderate taste with no significant irritation.

[0052] 1.3.5 Senior Citizen Formula (Suitable for seniors aged 60 and above): The core adjustment principle is "primarily for gum protection, gentle and non-irritating, easy to chew, and moisturizing to relieve oral dryness." Specific formulation adjustments include: 8-10 parts honeysuckle extract (increased dosage to enhance antibacterial and gum-protecting effects and relieve periodontal inflammation in the elderly), 3-4 parts magnolia bark extract (enhanced caries prevention, targeting the high incidence of root caries in the elderly), 1.5-2 parts clove extract (appropriately increased dosage to improve caries prevention efficacy), and 3-4 parts licorice extract (increased dosage to enhance mucosal protection and relieve oral mucosal dryness in the elderly). For dry and fragile gums: Peppermint extract 2-3 parts (moderate dosage, freshens breath, relieves bad breath, avoids irritation), xylitol 20-25 parts (moderate dosage, prevents tooth decay while avoiding excessive sweetness), monk fruit extract 4-5 parts (mild sweetness, helps relieve dry mouth), maltodextrin 15-20 parts (moderate dosage), microcrystalline cellulose 12-15 parts (increased dosage, improves tablet hardness while ensuring disintegration, suitable for the chewing strength of the elderly), magnesium stearate 1.5-2 parts (appropriately increased dosage, improves tablet lubrication, easier for the elderly to chew). Additional optimizations: The tablet hardness is slightly lower than the adult version, making it easier for the elderly to chew, while also increasing the synergistic effect of gum-protecting ingredients to alleviate common problems such as periodontal fragility and gingival bleeding in the elderly.

[0053] 1.3.6 Sensitive Individuals Formula (Suitable for those with sensitive oral mucosa and gums): The core adjustment principle is "extremely gentle, non-irritating, and primarily for mucosal protection." Specific formulation adjustments include: 5-6 parts honeysuckle extract (using a gentle purification process to reduce dosage and minimize irritation), 2-3 parts magnolia bark extract (gentle antibacterial, avoiding irritation), 1-1.2 parts clove extract (extremely low dose, avoiding taste irritation to sensitive oral mucosa), and 3-4 parts licorice extract (increased dosage). This formula includes: 2-2.5 parts peppermint extract (using a low-irritant extract to reduce dosage and avoid a cooling sensation), 22-26 parts xylitol (moderate dosage for a mild sweetness), 5-6 parts monk fruit extract (mild sweetness to balance the taste), 18-22 parts maltodextrin (moderate dosage to ensure proper tablet formation), 11-13 parts microcrystalline cellulose (moderate dosage to ensure disintegration), and 1-1.5 parts magnesium stearate (low dose, mild and non-irritating). Additional optimizations include: removal of all potentially irritating ingredients; use of low-temperature purified medicinal and edible extracts to reduce impurities; and a soft-crust formulation that disintegrates quickly after chewing to avoid friction and irritation to sensitive gums and mucous membranes. This also strengthens the mucosal protection components, relieving discomfort caused by oral sensitivity.

[0054] 2. Oral protective toothpaste

[0055] Oral protection toothpaste based on the synergistic effect of food and medicine homology and functional fruits (formula tailored to different population groups)

[0056] Core functions: Deeply cleans tooth surfaces, provides immediate antibacterial action, protects gums and enamel, cuts off extrinsic plaque irritation, and freshens breath. Suitable for daily brushing, it works synergistically with chewable tablets to achieve "cleaning + long-lasting protection." Addressing the diverse oral physiological characteristics and needs of different groups, based on the same core "principal, assistant, adjuvant, and guide" formulation system, the raw material ratios and component selections are optimized to create four differentiated formulas: children's, women's, elderly, and general population formulas. All adhere to the core protection goals of "cleaning-antibacterial-film protection-saliva production," strictly following the traditional Chinese medicine "principal, assistant, adjuvant, and guide" formulation theory. It selects medicinal and edible drugs and functional fruit extracts that meet the "National Food Safety Standard for Toothpaste Raw Materials," deeply synergizing with the toothpaste base, cleaning abrasives, and functional excipients. This strengthens oral health prevention and treatment effects (antibacterial, gum protection, caries prevention, fresh breath, and mucosal soothing) while ensuring the product's gentleness, stability, and palatability. All raw materials are non-irritating, easily soluble, and do not affect the toothpaste's consistency or long-term storage.

[0057] Core Formula Base (by weight, universal matrix for all skin types): Based on a food-grade cleaning matrix, including food-grade hydrated silica, glycerin, sodium carboxymethyl cellulose, and purified water, combined with core medicinal and edible extracts (honeysuckle extract, peppermint extract, and licorice extract) from the same source as the chewable tablets as the core active ingredients to ensure synergistic efficacy; xylitol is also added to enhance anti-caries effects. It is free of SLS foaming agents, artificial colors, and synthetic preservatives, making it gentle and non-irritating. The food-grade hydrated silica particles are rounded, cleaning the tooth surface without damaging the enamel; glycerin moisturizes and protects gums, preventing dry mouth; the same source of extracts works synergistically with the chewable tablets to achieve long-lasting protection after cleaning.

[0058] The core innovation of this invention lies in combining traditional Chinese medicine theory with modern oral pathology and the physiological characteristics of different populations. Through specific formulation and differentiated weight ratios, a five-dimensional synergistic protective system of "antibacterial, anti-adhesion, film protection, saliva production, and freshness" is constructed. It is precisely optimized for the oral needs of children (3-12 years old), women, the elderly (over 60 years old), and the general population. While achieving high efficiency, safety, and multiple effects, it provides a natural and pleasant taste experience, which is different from existing toothpaste formulas with single effects or simple superposition of raw materials.

[0059] 2.1 The oral protective toothpaste of this invention is based on the "principal, assistant, adjuvant, and guide" formulation system, and is divided into children's (3-12 years old), women's, elderly (60 years and above) and general population versions according to population differences. The active ingredients of each population version are composed of medicinal and edible homologous drugs and functional fruit extracts in the following weight ratios. The core components are homologous, and the differentiated components are adapted to the needs of the population:

[0060] This invention innovatively introduces extracts of medicinal and edible fruits and functional fruits such as Phyllanthus emblica, cranberry, loquat, and mulberry. Strictly adhering to the traditional Chinese medicine theory of "principal, assistant, adjuvant, and guide" in formulation, it constructs a five-dimensional synergistic system of "antibacterial, anti-adhesion, film protection, salivation promotion, and breath freshening." Based on the oral physiological characteristics of different populations (children have delicate teeth and are prone to swallowing; women are prone to sensitive gums and bad breath; the elderly are prone to dry mouth and fragile mucous membranes; the general population focuses on comprehensive protection), it optimizes the raw material ratio and component selection, resulting in four different formulations. This is a differentiated formula. Phyllanthus emblica and cranberry block plaque formation through "anti-biofilm + anti-adhesion" mechanisms, while loquat and Solomon's seal work together to relieve dry mouth. Mulberry and citrus fruits provide natural fruit flavor and antioxidant gum-protecting functions. These ingredients complement each other to achieve dual control over plaque, both cleaning existing plaque and preventing new plaque formation. Furthermore, the formula optimizes taste, gentleness, and efficacy for different groups, catering to the diverse needs of all age groups, unlike existing toothpaste formulas that rely on single-function ingredients or simple ingredient combinations.

[0061] 2.1.1 Core Ruler-Minister-Assistant-Guardian System (Universal core for all user groups, with differentiated adjustments to the proportions)

[0062] 2.1.1.1 Principal Ingredient (1 ingredient, core antibacterial and anti-inflammatory): Honeysuckle extract, added to all formulas, with the proportion adjusted according to individual tolerance: general population 0.3%–0.5%, children's formula 0.1%–0.2%, women's formula 0.2%–0.4%, elderly formula 0.2%–0.3%. It is sweet and cold in nature, and enters the lung, heart, and stomach meridians. Containing active ingredients such as chlorogenic acid, its core function is broad-spectrum antibacterial activity. It can specifically inhibit aerobic bacteria and early inflammation in the oral cavity, reduce gingival redness and swelling, and cut off the source of plaque growth. It is the core component of toothpaste for antibacterial and gum protection. Synergistically with other active ingredients, it can expand the antibacterial coverage, directly addressing the core pathogenesis of oral plaque irritation and microecological imbalance.

[0063] 2.1.1.2 Assistant Herbs (2-3 ingredients, for enhanced protection and blockage): The core ingredients are Phyllanthus emblica extract and cranberry extract, added to all formulas for all population groups, with differentiated ratios; auxiliary assistant herbs (Taraxacum mongolicum extract and Magnolia officinalis extract) are selectively added according to the needs of different population groups. Phyllanthus emblica extract, also known as Indian gooseberry, Yunnan olive, or Amla, is the dried, mature fruit of a plant in the Euphorbiaceae family, listed in Part I of the 2020 edition of the Chinese Pharmacopoeia and the list of medicinal and edible herbs. It is sweet, sour, and astringent in nature, cool in nature, and enters the lung and stomach meridians. It contains gallic acid, ellagic acid, vitamin C, etc., and its core characteristics are "sour and astringent with a sweet aftertaste, high antioxidant properties, and strong astringency." Its core effects include: effectively inhibiting oral cariogenic bacteria, periodontal pathogenic bacteria, and halitosis-related bacteria, destroying bacterial biofilms; reducing gingival inflammation, constricting capillaries, and reducing gingival bleeding; stimulating saliva secretion, relieving dry mouth, and neutralizing the root cause of halitosis; and its high antioxidant properties can scavenge free radicals and reduce oxidative damage to the gums. Its compatibility value lies in its synergistic effect with honeysuckle to broaden the antibacterial spectrum (covering both aerobic and anaerobic bacteria), its synergistic effect with magnolia bark to strengthen the anti-biofilm and anti-caries effect, its synergistic effect with licorice to construct a dual mucosal protection of "film protection + astringency", and its synergistic effect with taste modifiers to optimize the sensory experience. Simultaneously, it moderates the dryness of peppermint and honeysuckle, making the formula more suitable for long-term use. In this invention, the amla extract is in dry powder form, and its addition amount is 0.1% to 0.5% (parts by weight). Too low a dosage will result in insignificant efficacy and aftertaste, while too high a dosage can easily lead to discoloration of the paste (tannins reacting with iron ions) or an overly astringent taste. Appropriate antioxidants need to be added to prevent oxidation of the components, and mixing with strongly alkaline substances should be avoided. Cranberry extract: This is the dried or fresh fruit of a plant in the genus Vaccinium of the Ericaceae family. It is a functional fruit extract, sweet, sour, and cool in nature, and enters the stomach and bladder meridians. Its core active ingredients are type A proanthocyanidins, tannins, and phenolic acid compounds. Core oral pharmacological effects: It specifically inhibits Streptococcus mutans colonization through an anti-adhesion mechanism, preventing plaque formation and blocking tooth decay at its source, with low risk of drug resistance; it inhibits the formation of periodontal pathogenic bacteria biofilm, reducing gingival inflammation; its strong antioxidant properties reduce oxidative damage to periodontal tissues and assist in anti-inflammation. Its formulation logic: Synergistically with honeysuckle to form a three-dimensional defense of "bactericidal + plaque-inhibiting" (honeysuckle removes airborne bacteria, cranberry blocks new plaque formation); synergistically with xylitol to construct a natural sugar-free taste system, providing natural fruit aroma and color; it needs to be combined with licorice extract or buffering agents to neutralize the acidity of its natural fruit acids, avoiding acid erosion of tooth enamel; its deep red pigment can be addressed through microencapsulation or by using a bleaching extract. This invention uses standardized extracts (proanthocyanidin content ≥5%) or cranberry powder, added at 0.1%–0.5% (parts by weight). Excessive dosage can easily lead to pH imbalance or an overly acidic taste.

[0064] Dandelion extract (auxiliary ingredient): It is bitter, sweet, and cold in nature, and enters the liver and stomach meridians. It contains taraxasterol and flavonoids, and has a prominent broad-spectrum antibacterial effect. It can specifically inhibit cariogenic bacteria and periodontal pathogens, reduce gingival inflammation, clear heat and reduce swelling, and relieve gingival swelling and pain. When combined with honeysuckle, it can enhance the antibacterial effect and meet the core needs of oral protection. The addition amount is 0.1% to 0.4% (parts by weight), and the amount of raw materials can be expanded within the range of 0.1% to 1.2%.

[0065] 2.1.1.3 Adjuvant herbs (2-4 herbs, for protecting the membrane, promoting salivation, and harmonizing the medicinal properties): The core herbs are licorice extract, Solomon's seal extract, and loquat extract, which are added to all population groups, with the proportions adjusted differently; auxiliary adjuvant herbs (mulberry extract, tangerine peel extract, kiwi extract, etc.) are selectively added according to the needs of the population.

[0066] Licorice extract: It is sweet and neutral in nature, and enters the heart, lung, spleen, and stomach meridians. It contains glycyrrhizic acid, glycyrrhizin, and other components. Its core functions are to protect the oral mucosa, soothe irritation, and harmonize the properties of other medicines. It can cover the mucosa to form a protective barrier, relieve pain, and neutralize the cold or irritating properties of other ingredients. It is the core guarantee for the safety of the formula and is suitable for all people, especially sensitive people. The addition amount is 0.2% to 0.6% (by weight), which can be adjusted according to the sensitivity of the individual.

[0067] Polygonatum odoratum extract: It is sweet and slightly cold in nature, and enters the lung and stomach meridians. It contains Polygonatum odoratum polysaccharides and other ingredients. Its core functions are to nourish the oral mucosa, relieve oral dryness, assist in anti-oxidation, and protect tooth enamel. It is suitable for toothpaste for the elderly. It works synergistically with glycerin and propylene glycol to enhance the moisturizing effect and reduce bad breath caused by oral dryness. The addition amount is 0.1% to 0.4% (parts by weight).

[0068] Loquat extract: It quenches thirst, soothes throat discomfort, and works synergistically with Solomon's seal to relieve dry mouth and enhance the effects of quenching thirst and protecting the oral mucosa. The dosage is 0.3% to 1.0% (parts by weight).

[0069] Mulberry extract (adjuvant): Contains anthocyanins and tannins. Its core functions are anti-oxidation and antibacterial properties, assisting in gum protection and improving gum discoloration. It provides a gentle and natural color, replacing artificial pigments and meeting the coloring needs of toothpaste. It is gentle and non-irritating, suitable for sensitive people. The addition amount is 0.1% to 0.4% (parts by weight), and the amount of raw materials can be expanded within the range of 0.1% to 1.2%.

[0070] Kiwi fruit extract (adjuvant): Rich in vitamin C, its core functions are anti-oxidation, protection of oral mucosa, and assistance in repairing minor mucosal damage. Suitable for sensitive individuals (women's formula, general sensitive individuals). It can enhance the mucosal protection effect when combined with licorice extract. Addition amount: 0.1% to 0.3% (parts by weight).

[0071] 2.1.1.4 Additives (2-4 flavors, for refreshing, flavoring, and stabilizing dosage forms): The core ingredients are menthol and xylitol, which are added to all population groups, with the proportions adjusted differently; other additives (bamboo leaf extract, perilla leaf extract, orange extract, grapefruit extract, monk fruit extract, strawberry extract) are selectively added according to the taste and efficacy needs of the population, and the amount added is controlled within the range of 0.1% to 1.2% of the expandable raw material usage (except for xylitol, which is 2.0% to 5.0%).

[0072] Menthol (corresponding to the core ingredient of peppermint extract): It is pungent and cool in nature, and enters the lung and liver meridians. It contains menthol and other ingredients. Its core functions are to clear heat and soothe the throat, freshen breath, relieve mild discomfort of the gums, and bring a cool and comfortable feeling. At the same time, it can improve the taste of toothpaste. However, its pungent and drying properties need to be controlled by other ingredients to avoid long-term use leading to dryness of the oral mucosa.

[0073] Xylitol: As a natural sweetener, it enhances the anti-caries effect and works synergistically with fruit extracts to create a sugar-free taste system. The addition amount is 2.0% to 5.0% (parts by weight).

[0074] Orange extract and strawberry extract: provide natural fruity aroma, balance the bitterness of herbs, optimize the taste, and are suitable for children's and women's formulas; grapefruit extract and monk fruit extract: clear heat and promote body fluid production, relieve dry mouth, and are suitable for the elderly; perilla leaf extract: mitigates the cold nature of the formula and is suitable for people with a cold spleen and stomach (some elderly people and the general population).

[0075] 2.1.2 Specific formulation composition for different population groups (parts by weight, only the differentiating components and their proportions are listed; the general matrix is ​​the same as in 2.4)

[0076] 2.1.2.1 Children's version (suitable for children aged 3-12 years, core requirements: anti-caries, gentle, low irritation, easy to accept, suitable for children's delicate teeth and easy swallowing characteristics)

[0077] 2.1.2.1.1 Principal ingredient: Honeysuckle extract 0.1%–0.2% (reduce dosage to minimize cold and irritating effects, and suit children's digestive function)

[0078] 2.1.2.1.2 Subsidiary ingredients: Phyllanthus emblica extract 0.1%–0.2%, Cranberry extract 0.1%–0.2% (reduce dosage to enhance caries prevention and avoid excessive sourness; do not add dandelion extract to reduce cold stimulation)

[0079] 2.1.2.1.3 Adjuvants: Licorice extract 0.4%–0.6% (increase dosage to strengthen mucosal protection, soothe irritation, and reduce the risk of accidental ingestion), Polygonatum odoratum extract 0.1%–0.2% (add in small amounts for mild moisturizing), loquat extract 0.3%–0.5% (add in small amounts for promoting salivation without irritation); mulberry extract 0.1%–0.2% (optional, provides a mild color, replacing artificial pigments)

[0080] 2.1.2.1.4 Additives: Menthol 0.3%–0.5% (reduce dosage to minimize cooling and irritation, avoiding stimulation of children's oral mucosa), xylitol 3.0%–5.0% (increase dosage to enhance sweetness and improve children's acceptance), orange extract 0.3%–0.5%, strawberry extract 0.3%–0.5% (enhance fruity aroma, mask herbal taste, and suit children's palates); no perilla leaf extract or grapefruit extract added (to avoid complex taste).

[0081] 2.1.2.1.5 Special Optimizations: Food-grade hydrated silica uses ultra-fine soft particles to reduce hardness and avoid abrading children's delicate tooth enamel; a low-foaming formula is used to reduce the foreign body sensation when swallowing; and there are no irritating ingredients throughout the process to ensure that there is no safety hazard if children accidentally swallow small amounts.

[0082] 2.1.2.2 Women's Version (Suitable for women aged 18-60, core needs: gum care, soothing sensitivity, fresh breath, and antioxidant properties; suitable for women with sensitive gums during menstruation, prone to bad breath, and who pay attention to skin and oral health)

[0083] 2.1.2.2.1 Principal drug: Honeysuckle extract 0.2%–0.4% (moderate dosage to enhance antibacterial and anti-inflammatory effects and relieve gingival sensitivity and inflammation)

[0084] 2.1.2.2.2 Substitutes: Phyllanthus emblica extract 0.3%–0.5%, cranberry extract 0.3%–0.5% (moderate dosage to enhance anti-adhesion, prevent caries, and improve breath; dandelion extract 0.2%–0.3% can be selected to enhance anti-inflammation and relieve menstrual gum swelling and pain)

[0085] 2.1.2.2.3 Adjuvants: Licorice extract 0.3%–0.5% (moderate dosage, strengthens mucosal protection, relieves gum sensitivity), Polygonatum odoratum extract 0.2%–0.3%, loquat extract 0.5%–0.8% (synergistically promotes saliva production, improves dry mouth during menstruation; add kiwi extract 0.2%–0.3%, strengthens antioxidant properties, repairs mucosa, suitable for sensitive oral cavity); optional mulberry extract 0.2%–0.4% (antioxidant, brightens gum color, meets women's skincare-grade oral care needs)

[0086] 2.1.2.2.4 Additives: Menthol 0.5%–0.8% (moderate dosage, freshens breath, provides a comfortable cooling sensation), Xylitol 2.0%–3.0% (moderate dosage, prevents tooth decay without affecting taste), Orange extract 0.2%–0.4%, Grapefruit extract 0.2%–0.3% (natural fruit aroma, freshens breath, enhances user experience); No perilla leaf extract added (to avoid a heavy taste).

[0087] 2.1.2.2.5 Special Optimization: Enhanced antioxidant components (mulberry and kiwi extracts) to meet women's antioxidant needs; the formula is gentle and non-irritating, suitable for women during menstruation and pregnancy (all raw materials are food-grade and free of risky ingredients); the taste is fresh and mild, avoiding a strong bitter taste.

[0088] 2.1.2.3 Senior Citizen Version (Suitable for people over 60 years old, core needs: saliva production, moisturizing, film protection, gentle, low irritation, suitable for the characteristics of the elderly such as fragile oral mucosa, easy dry mouth, receding gums, and sensitive teeth)

[0089] 2.1.2.3.1 Principal herb: Honeysuckle extract 0.2%–0.3% (reduce dosage to minimize cold and irritating effects, and suit the spleen and stomach function of the elderly)

[0090] 2.1.2.3.2 Subsidiary ingredients: Phyllanthus emblica extract 0.2%–0.4%, Cranberry extract 0.2%–0.4% (moderate dosage to enhance antibacterial activity and avoid acidic or astringent irritation; dandelion extract is not added to reduce cold and cooling irritation)

[0091] 2.1.2.3.3 Adjuvants: Licorice extract 0.4%–0.6% (increase dosage to strengthen mucosal protection, relieve pain, and suit the characteristics of fragile mucosa), Polygonatum odoratum extract 0.3%–0.4% (increase dosage to strengthen moisturizing and nourishing mucosa, and relieve dry mouth), Loquat extract 0.8%–1.0% (increase dosage for powerful saliva production and relief of dry mouth and tongue in the elderly; optional tangerine peel extract 0.2%–0.3% can be used to balance the cold nature of the formula and suit the elderly with a cold spleen and stomach).

[0092] 2.1.2.3.4 Medications: Menthol 0.3%–0.5% (reduce dosage to minimize cooling and irritation, avoiding stimulation of fragile mucous membranes), Xylitol 2.0%–3.0% (moderate dosage, prevents tooth decay and is non-irritating), Grapefruit extract 0.3%–0.4%, Monk fruit extract 0.1%–0.15% (synergistically promotes saliva production, freshens breath, and relieves bad breath caused by dry mouth); Perilla leaf extract 0.2%–0.3% is added to balance the cold nature of the formula and protect the spleen and stomach.

[0093] 2.1.2.3.5 Special Optimizations: Added moisturizing and thirst-quenching components (Polygonatum odoratum, loquat, and monk fruit extracts) to relieve oral dryness in the elderly; reduced hardness of cleaning particles to avoid abrasion and gum recession; gentle and non-irritating formula suitable for people with sensitive teeth and fragile mucous membranes.

[0094] 2.1.2.4. General Population Version (Suitable for people aged 12-55 without special oral health issues. Core needs: comprehensive cleaning, gum protection, antibacterial properties, fresh breath, suitable for daily use, balancing efficacy and taste)

[0095] 2.1.2.4.1 Principal drug: Honeysuckle extract 0.3%–0.5% (standard dosage, to enhance broad-spectrum antibacterial activity and cut off the source of bacterial plaque)

[0096] 2.1.2.4.2 Subsidiary Drugs: Phyllanthus emblica extract 0.3%–0.5%, Cranberry extract 0.3%–0.5% (standard dosage, to enhance anti-biofilm and anti-adhesion effects, achieving full-chain caries prevention; optional dandelion extract 0.2%–0.4%, Magnolia officinalis extract 0.1%–0.3%, to enhance antibacterial and anti-biofilm effects)

[0097] 2.1.2.4.3 Adjuvants: Licorice extract 0.2%–0.4% (standard dosage, to harmonize the medicinal properties and protect the mucous membrane), Polygonatum odoratum extract 0.2%–0.3%, loquat extract 0.5%–0.7% (synergistically promote body fluid production and protect the mucous membrane); mulberry extract 0.2%–0.3% and Lophatherum gracile extract 0.1%–0.3% may be used to enhance antioxidant properties and clear heat and promote body fluid production.

[0098] 2.1.2.4.4 Medications: Menthol 0.6%–1.0% (standard dosage, freshens breath and provides a cooling sensation), Xylitol 2.5%–4.0% (standard dosage, prevents tooth decay and improves taste), Orange extract 0.2%–0.5%, Lophatherum gracile extract 0.1%–0.3% (synergistically freshens breath and improves taste); Perilla frutescens leaf extract 0.1%–0.3% (optional, suitable for people with a cold spleen and stomach).

[0099] 2.1.2.4.5 Special Optimizations: The formula is balanced, taking into account all aspects of antibacterial, anti-caries, freshening, and film protection; the taste is moderate, cool and sweet, suitable for most people's daily use habits; there are no special irritating ingredients, suitable for people without serious oral problems.

[0100] 2.2. The key synergistic mechanism and innovation of this invention lie in:

[0101] 2.2.1 Systematic Collaboration of "Emperor, Minister, Assistant, and Envoy" (Targeted Optimization Based on Different Groups):

[0102] 2.2.1.1 Antibacterial Network: The broad-spectrum bactericidal effect of the principal ingredient (honeysuckle), combined with the biofilm disruption of the secondary ingredients (emblica) and the adhesion blocking effect of the secondary ingredient (cranberry), constitutes a multi-target, three-dimensional antibacterial system covering the entire life cycle of bacterial plaque (planktonic, colonization, maturation), providing full-chain protection with significantly better efficacy than single ingredients. The formulation is adjusted for different populations: the dosage of the principal and secondary ingredients is reduced in children's and elderly formulas to minimize irritation, while the dosage is enhanced as needed in women's and general population formulas, achieving a balance between efficacy and gentleness. Specifically, the extracts of Phyllanthus emblica and Lonicera japonica (principal ingredients): Lonicera japonica focuses on inhibiting aerobic bacteria and early inflammation, while Phyllanthus emblica has stronger penetrating power against anaerobic bacteria and dental plaque biofilm. Together, they form a dual antibacterial coverage of "aerobic + anaerobic," compensating for the blind spots of single-ingredient antibacterial spectrum. The high antioxidant properties of Phyllanthus emblica can assist Lonicera japonica in scavenging free radicals and reducing oxidative stress damage to the gums after brushing. The extracts of Phyllanthus emblica and Magnolia officinalis (auxiliary ingredients): Magnolia officinalis mainly inhibits bacterial adhesion, while the tannins in Phyllanthus emblica can coagulate bacterial surface proteins, inactivating the bacteria. Together, they form an "inhibition of bacterial growth" effect. The synergistic effect of "accelerating plaque breakdown" enhances the anti-biofilm and anti-caries / anti-scaling effects; Cranberry extract and honeysuckle extract (principal ingredients): Honeysuckle is responsible for removing established airborne bacteria, while cranberry blocks the formation of new plaque through its anti-adhesion mechanism. The two form a three-dimensional defense of "bactericidal + anti-scaling" to compensate for the inadequacy of a single antibacterial strategy; Dandelion extract and honeysuckle extract (principal ingredients): Both have broad-spectrum antibacterial effects. Their synergistic effect can enhance the inhibitory effect on cariogenic bacteria and periodontal pathogens, improve anti-inflammatory and swelling-reducing abilities, and relieve gum swelling and pain (suitable for women's and general populations).

[0103] 2.2.1.2 "Protecting Mucosa and Promoting Saliva Production" Gentle Protection System: The adjuvant ingredients (licorice, Solomon's seal, loquat) work synergistically through different targets (mucosal repair, tissue nourishment, saliva stimulation) to effectively alleviate discomfort caused by brushing friction, the inherent coldness and dryness of the ingredients, and oral dryness. The formula is optimized for different groups: the elderly and women's formulas have increased adjuvant dosage to strengthen mucosal protection and promote saliva production; the children's formula has increased licorice dosage to reduce the risk of accidental swallowing; the general population formula has a balanced formula to ensure gentleness and safety for long-term use. The specific synergistic mechanism is as follows: Phyllanthus emblica extract and Glycyrrhiza uralensis extract (adjuvants): Glycyrrhizin provides mucosal protection and relieves pain, while Phyllanthus emblica tannins astringe capillaries and reduce gingival bleeding. The two form a dual protection of "mucosal protection and hemostasis," which is especially suitable for people with gingivitis and those who bleed easily when brushing their teeth (women's version, general version); Polygonatum odoratum extract, Actinidia chinensis extract and Glycyrrhiza uralensis extract (adjuvants): They synergistically nourish the oral mucosa, repair minor mucosal damage, relieve oral dryness and sensitivity, and enhance the gentleness of the formula, making it suitable for sensitive people (women's version) and the elderly; Polygonatum odoratum, Eriobotrya japonica and Pear extracts work synergistically to further enhance the moisturizing effect and relieve discomfort in the elderly and those with dry mouth.

[0104] 2.2.1.3 Taste and Dosage Form Optimization (Population-Specific Adaptation): The active ingredients (xylitol, menthol, etc.) not only provide a pleasant natural taste, but their specific physicochemical properties (such as xylitol's anti-caries properties and menthol's penetration-enhancing properties) also contribute to the stability and release of the active ingredients. Taste optimization is tailored to different population groups: the children's version increases the amount of fruit extracts and xylitol to mask the herbal taste and improve acceptability; the women's version emphasizes a refreshing fruity aroma to suit female preferences; the elderly version reduces the amount of menthol and increases the amount of thirst-quenching active ingredients to relieve dry mouth; the general population version offers a balanced taste to meet the needs of the general public. Specifically, the following ingredients are used in combination: Phyllanthus emblica extract with xylitol and monk fruit extract (as an adjuvant): Phyllanthus emblica's "sour and astringent with a sweet aftertaste" mask the bitterness of the herbs, while the sour and astringent sensation stimulates saliva production. Combined with the cooling effect of xylitol, this creates a three-stage taste sensation: "stimulating saliva production upon entry → refreshing and cleansing in the middle → lingering sweetness and fragrance in the later stage," solving the problem of a dull taste in pure herbal toothpaste. Phyllanthus emblica extract with peppermint extract (as an adjuvant): Phyllanthus emblica is cool and moistening, promoting saliva production and astringing yin, effectively neutralizing the pungent and drying properties of menthol and preventing dry mouth and tongue caused by long-term use. Cranberry, strawberry, orange, grapefruit, and other fruit extracts with xylitol (as an adjuvant): Fruit extracts provide natural fruit aromas, working synergistically with xylitol to create a natural, sugar-free taste system, improving product acceptance, especially suitable for children and female users. Orange extract with toothpaste base: Citric acid in oranges can adjust the pH value of the toothpaste, enhance the stability of the paste, aid in the dissolution of various ingredients, and improve the uniformity of the formula.

[0105] 2.2.1.4 "Ingredient-Formulation" Adaptability Process: The antioxidant properties of amla polyphenols help stabilize the toothpaste, citrus organic acids adjust the pH of the system, and it is scientifically formulated with specific abrasives (such as hydrated silica), humectants (glycerin, sorbitol), and mild foaming agents (sodium lauroyl sarcosinate), etc., to optimize the process for different groups: the children's version uses ultra-fine soft abrasives and a low-foaming formula; the elderly version increases the proportion of humectants and reduces the hardness of the abrasives; the women's version and the general population version optimize the fineness of the toothpaste to ensure the stability, compatibility and efficient release of each active ingredient in the toothpaste. The specific synergistic effects are as follows: Phyllanthus emblica extract and hydrated silica (abrasive): The organic acids in Phyllanthus emblica can gently soften the organic matrix of dental plaque, improve the cleaning efficiency of physical friction of hydrated silica, and achieve synergistic stain removal through "chemical softening + physical scraping"; Phyllanthus emblica extract and sodium carboxymethyl cellulose (binder): The polyphenols in Phyllanthus emblica have natural preservative and antioxidant capabilities, which can help maintain the stability of the paste and prevent the paste from oxidizing, rancid, or discoloring.

[0106] 2.2.2 Innovation of Group-Specific Formulas: Based on the same core formulation system, the formula precisely optimizes the ratio of raw materials and selection of components to address the differences in oral physiological characteristics and needs of different groups, achieving differentiated protection for each individual. This ensures consistent core efficacy while addressing the personalized oral problems of different groups, unlike existing toothpaste formulas that lack differentiation or simply adjust the taste. All group-specific formulas adhere to the principles of naturalness, gentleness, and safety, are adapted to the physiological tolerance of their respective groups, and contain no targeted irritating ingredients.

[0107] 2.2.3 Programmed Synergy with Chewable Tablets:

[0108] All versions of this toothpaste share the same active ingredient profile as the accompanying chewable tablets (such as honeysuckle, licorice, and xylitol), but their functions are clearly differentiated in terms of formulation. The toothpaste primarily "cleans," achieving immediate cleaning through physical friction and rapid antibacterial action; the chewable tablets primarily "nourish," providing long-lasting conditioning through sustained-release action. Based on the same active ingredients, both achieve a synergistic effect of "cleansing first, then nourishing, with complementary cleansing and nourishing properties" for different user groups, enhancing oral protection.

[0109] 2.2.4 The natural and gentle properties of the formula:

[0110] The formula for all age groups is free of controversial ingredients such as SLS, artificial colors, synthetic fragrances, and parabens. It utilizes sodium lauroyl sarcosinate, food-grade abrasives, natural extracts, and sweeteners to ensure the product is gentle and safe for all ages, especially children, pregnant women, and those with sensitive mouths. Optimization for different age groups further enhances the formula's suitability for each individual, reducing the risk of targeted irritation.

[0111] 2.3 Explanation of Security and Differentiation Adjustments

[0112] All the above raw materials are selected from the "List of Substances That Are Both Food and Medicine", the "List of Substances That Can Be Used in Health Foods", and the "Chinese Pharmacopoeia", and comply with the "National Food Safety Standard for Raw Materials Used in Toothpaste". Each extract is made from food-grade materials, and the dosage has been optimized to ensure efficacy while posing an extremely low risk of oral ingestion, ensuring high safety and suitability for the physiological characteristics of various population groups.

[0113] 2.3.1 Raw Material Safety: All medicinal and edible drugs and functional fruit extracts comply with the "National Food Safety Standard for Raw Materials Used in Toothpaste", the "Pharmacopoeia of the People's Republic of China", and relevant catalogs of medicinal and edible drugs. Long-term practical verification has shown that they are highly safe and have no obvious toxic side effects. All are food-grade or pharmaceutical-grade and can safely come into contact with the oral mucosa. There is no safety hazard if children accidentally swallow small amounts. For pregnant women and breastfeeding women (suitable for women's products), all potentially risky ingredients have been removed to ensure safe use.

[0114] 2.3.2 Irritation Avoidance: The combination of licorice extract neutralizes the acidity of raw materials such as amla and cranberry, as well as the coldness of honeysuckle and peppermint, thus mitigating the frictional irritation of hydrated silica. The dosage of all raw materials has been scientifically optimized. The dosage of cold ingredients has been reduced in the children's and elderly versions, while the women's version has enhanced sensitivity protection. Mild raw materials (such as kiwi and Solomon's seal extract) are preferred for sensitive groups (women's version and some general populations), and potential irritating ingredients are eliminated. The elderly version has reduced abrasive hardness to avoid irritating fragile gums.

[0115] 2.3.3 Safety and Suitability for Each Population: Each product is optimized for the physiological characteristics of its respective population. The children's product is suitable for children with delicate teeth and easy swallowing, with low irritation, low dosage, and soft abrasive. The women's product is suitable for sensitive needs during menstruation and pregnancy, with enhanced protective film and antioxidant properties. The elderly product is suitable for elderly people with fragile mucous membranes and prone to dry mouth, with enhanced moisturizing, saliva production, and protective film properties. The general population product is suitable for daily protection, with a balanced and gentle formula. As an ingredient in topical toothpaste, the oral intake of amla extract is extremely small, and the potential risks brought by its cooling properties are controllable. It can be noted that "those with spleen and stomach deficiency and cold, or loose stools should use with caution" (suitable for the elderly product and some general populations).

[0116] 2.3.4 Application Notes:

[0117] 2.3.4.1 Raw material positioning: Phyllanthus emblica extract and cranberry extract are recommended to be used as adjuvant or special adjuvant drugs. Other medicinal and edible drugs and functional fruit extracts can be added as adjuvant or auxiliary efficacy components according to the formulation needs of each population group, and seamlessly connected with the existing monarch-minister-adjuvant-guide system. In the formulation for different population groups, the core components (honeysuckle, licorice, xylitol, etc.) remain homologous, and the differentiated components are added or removed according to the needs of the population group.

[0118] 2.3.4.2 Dosage control: Phyllanthus emblica extract 0.1%–0.5% (parts by weight), cranberry extract 0.1%–0.5% (parts by weight), other optional ingredients are recommended to be controlled at 0.1%–1.2% (parts by weight), xylitol 2.0%–5.0% (parts by weight). For different groups, adjust within the above range according to needs to avoid excessive dosage affecting the stability of the paste, taste or causing irritation.

[0119] 2.3.4.3 Process Notes: Phyllanthus emblica extract is rich in polyphenols and easily oxidized; therefore, an appropriate amount of antioxidant should be added or the material should be added under inert gas protection to avoid mixing with strongly alkaline substances. For cranberry extract, attention should be paid to pigment stability; microencapsulation technology can be used. For children's products, ultrafine soft hydrated silica should be selected, and a low-foaming process should be adopted. For products for the elderly, the proportion of moisturizer should be increased, and the abrasive hardness reduced. All extracts are food-grade and comply with relevant national standards.

[0120] 2.4 Beneficial Effects

[0121] The oral protective toothpaste provided by this invention achieves the following beneficial effects through a rigorous "principal, assistant, adjuvant, and guide" formulation, a multi-dimensional synergistic mechanism, and precise optimization for different user groups:

[0122] 2.4.1 Comprehensive and Synergistic Efficacy with Differentiated Adaptation: Integrating antibacterial, anti-caries, gum protection, freshening, soothing, and antioxidant properties, the core efficacy is unified. Simultaneously, it optimizes the emphasis of efficacy to meet the personalized needs of children, women, the elderly, and the general population, achieving precise protection tailored to each individual. The protective effect is significantly superior to single-function products, simple compound products, and undifferentiated formulas. Various medicinal and edible herbs and functional fruit extracts synergistically complement each other, covering all oral protection scenarios for different populations and addressing multiple oral problems such as plaque, inflammation, dryness, odor, and sensitivity.

[0123] 2.4.2 Safe and gentle, suitable for all people: All-natural raw materials, free of chemical antibacterial agents, synthetic fragrances and pigments. Through internal formulation, it effectively balances imbalances, optimizes dosage and components for different groups, reduces the risk of targeted irritation, is friendly to oral mucosa, and is suitable for people of all ages and physiological states (including children, women and the elderly). The safety of raw materials has been verified by authoritative standards, and the risk of use is extremely low.

[0124] 2.4.3 Pleasant taste and suitable for different groups: The taste is optimized for different groups. The children's version has a rich fruity aroma and moderate sweetness, the women's version is fresh and mild, the elderly version is gentle and non-irritating, and the general population version is cool and sweet. The unique natural fruit flavor and three-stage taste improve the user compliance of each group, especially solving the pain points of children resisting herbal toothpaste and the elderly being unsuitable for cool and irritating toothpaste.

[0125] 2.4.4 Stable and industrially viable formulations: The components of each group of people's formulas have good compatibility with the toothpaste matrix, the process is feasible, and it is easy to achieve standardized production and quality control. The raw materials are readily available and the dosage is scientific, which can be mass-produced on a large scale. At the same time, it avoids process problems such as raw material oxidation, toothpaste discoloration, and abrasive irritation. The formulations for different groups of people are based on the same core system, and the production line can be shared to reduce the cost of industrial production.

[0126] 3. External application of hydrophilic gel patch for acupoints

[0127] 3.1 Dosage Form Characteristics and Core Functions

[0128] The hydrophilic gel patch for external acupoint application is the core dosage form for the external treatment of oral discomfort in this invention. It is highly hydrophilic, breathable, mildly adhesive, leaves no residue, and is gentle and low-irritant. It also boasts advantages such as high transdermal absorption efficiency, good adherence, high skin compatibility, and gentle, sustained-release efficacy. It can precisely adapt to the acupoint application needs of different types of oral discomfort, which is a key technical feature distinguishing this invention from existing oral external products. It enables continuous transdermal sustained release of active ingredients, prolonging the soothing effect.

[0129] This invention overcomes the aforementioned limitations. Based on the pathogenesis and characteristics of oral discomfort, which is "originating from within and affecting both the exterior and interior," and the laws of meridian conduction, it creatively constructs a precise correspondence system of "syndrome type-formula-acupoint-acupoint combination method." With the exterior-interior acupoint combination method as the core, it combines distal acupoint combination, upper and lower acupoint combination, and Shu-Mu acupoint combination to achieve "acupoint targeted relief, unblocking meridians and blood circulation, reducing gingival redness, swelling and pain, and improving oral mucosal discomfort." It works synergistically with oral protective chewable tablets and special protective toothpaste to form a three-in-one protection mode of "brushing cleaning + chewing conditioning + acupoint external treatment," achieving the effects of treating both the exterior and interior, addressing both the root cause and symptoms, and regulating both acute and chronic conditions.

[0130] 3.2 Core Acupoint Selection Principles

[0131] 3.2.1 The method of selecting acupoints based on their exterior and interior features (core principle)

[0132] Selecting acupoints near the face and mouth to relieve pain, reduce swelling and soothe the exterior; selecting acupoints on the extremities and back to regulate the internal organs, harmonize qi and blood, and strengthen the root cause (treating the interior), thus resolving the exterior pathogens and harmonizing the interior qi, which is consistent with the pathogenesis of oral discomfort caused by stomach fire, yin deficiency, spleen deficiency, wind-heat, cold-dampness and other diseases that affect both the exterior and interior.

[0133] 3.2.2 Combining Distal and Proximity Acupoint Selection with Meridian-Based Acupoint Selection

[0134] Acupoints are selected along the Yangming, Shaoyin, and Taiyin meridians. Local acupoints quickly relieve swelling and pain, while distal acupoints regulate the root cause of viscera, achieving "treating the symptoms locally and the root cause remotely".

[0135] 3.2.3 Synergistic Effect of Multiple Acupoint Combinations

[0136] By combining the Yu and Mu acupoints to regulate the spleen and stomach deficiency and excess, the upper and lower acupoints to moisten dryness and yin and yang, and the left and right acupoints to balance qi and blood, a comprehensive and multi-level acupoint conditioning system is constructed, so that the efficacy of medicine can be transmitted along the meridians, and the effects of soothing, protecting gums, promoting body fluid production and repair can be enhanced.

[0137] 3.3 Differential Diagnosis and Treatment of Topical Hydrophilic Gel Patches

[0138] This invention follows the principles of "treatment based on syndrome differentiation, homology between medicine and acupoints, and gentle compatibility." It designs specific patch formulas and acupoint combinations for each of the five core syndrome types of oral discomfort. All raw materials are extracts derived from both food and medicine, and are synergistically compatible with specialized protective toothpaste and oral protective chewable tablets. The patches are safe, non-irritating, and suitable for adults, the elderly, children, and sensitive individuals. Specific syndrome differentiation and patch applications are as follows:

[0139] 3.3.1 Stomach Fire Excess Syndrome (Acute inflammatory phase of oral cavity / mild case, corresponding to the pathogenesis of stomach fire rising upward, attacking upward along the meridian, and simultaneous exterior and interior disease)

[0140] 3.3.1.1. Symptoms: Red, swollen, and burning gums with significant pain, accompanied by oral ulcers, halitosis, dry mouth, bitter taste, constipation, and scanty, yellow urine. The tongue coating is yellow and greasy, and the pulse is slippery and rapid. It is mostly caused by spicy food and emotional imbalance leading to excessive stomach fire, which attacks the oral cavity along the Yangming meridian and also affects the skin surface. It is the most common syndrome of acute oral discomfort, mainly characterized by excess in the superficial aspects, with both superficial and internal diseases, and no obvious deficiency of the internal organs.

[0141] 3.3.1.2 Targeted Acupoints

[0142] Based on the principle of exterior-interior acupoint selection, this treatment combines specific functional acupoints with meridian-based acupoints. It selects acupoints related to clearing heat and purging fire, reducing swelling and relieving pain, along with superficial connecting points. The treatment utilizes both distal and distal acupoint selection methods, as well as upper and lower acupoint selection. The main application areas are the face, around the mouth, and lower limbs. The patches are pre-made in 3cm x 3cm (face / around the mouth) and 2.5cm x 2.5cm (lower limbs) sizes to fit snugly against the acupoints and avoid pulling on the delicate facial skin.

[0143] 3.3.1.2.1 Core acupoints (internal and external points): Internal organ points (Neiting, Weishu) + External connecting points / internal and external pivot points (Jiache, Dicang).

[0144] 3.3.1.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0145] 3.3.1.2.2.1 Treating the interior and strengthening the foundation: Neiting (Ying-Spring point of the Stomach Meridian) and Weishu (Back-Shu point of the Stomach) are the fundamental points of the internal organs. They clear heat and purge fire, harmonize the stomach and relieve pain, directly targeting the core pathogenesis of "excessive stomach fire", clearing and purging the excess fire in the stomach and treating the root cause of stomach fire attacking upwards.

[0146] 3.3.1.2.2.2. Treating the exterior and dispelling pathogens: Jiache (acupoint of the Stomach Meridian) and Dicang (acupoint of the Stomach Meridian) are surface connecting points located around the face and mouth, directly reaching the affected area. They reduce swelling and pain, dredge local meridians, and relieve stomach fire by attacking the surface of the mouth along the meridian, quickly relieving red and swollen gums and pain.

[0147] 3.3.1.2.2.3 Synergistic effect between exterior and interior: The combination of acupoints regulates the exterior and interior of the Stomach Meridian, which not only clears and purges the excess heat in the stomach and strengthens the body, but also unblocks the local meridians to relieve exterior symptoms, quickly clears stomach heat, and prevents the heat from spreading and aggravating oral mucosal damage.

[0148] 3.3.1.2 Raw materials and weight ratios of corresponding hydrophilic gel poultices

[0149] 3.3.1.2.1. The heat-clearing and fire-purging hydrophilic gel patch is based on the core functions of "clearing heat and purging fire, inhibiting bacteria and reducing swelling, and unblocking meridians and relieving pain". It also takes into account treating the internal and strengthening the body, and treating the external and eliminating pathogens. The raw materials are slightly cool but mild in nature, with good transdermal properties, and are suitable for short-term application to relieve acute discomfort.

[0150] 3.3.1.2.1.1 Weight ratio: honeysuckle 3-5 parts, dandelion 2-4 parts, menthol 0.3-0.8 parts, peony bark 1-2 parts, red peony root 1-2 parts, licorice 0.5-1 parts.

[0151] 3.3.1.2.1.2 Matrix formulation (per 100g of ointment): Carbomer 940 6.0-7.0g, hydroxypropyl cellulose 1.0-2.0g, glycerin 20.0-22.0g, propylene glycol 8.0-10.0g, polyethylene glycol 400 2.0-4.0g, azone 1.2-1.5g, triethanolamine 2-2.5g, benzalkonium bromide 0.06-0.08g, purified water to 100g (pH 6.0-6.5, hydrophilic matrix, non-greasy after application, low skin irritation, suitable for facial application).

[0152] 3.3.1.3 Patch compatibility logic and mechanism of action

[0153] 3.3.1.3.1 Principal herbs: honeysuckle and dandelion. The two herbs work together to clear heat and purge fire, inhibit bacteria and reduce swelling, directly targeting the core pathogenesis of "excessive stomach fire". They are highly compatible with the "clearing heat and harmonizing the stomach" therapeutic effects of the viscera and acupoints such as Neiting and Weishu, thus treating the interior and strengthening the foundation.

[0154] 3.3.1.3.2 Assistant herbs: Moutan bark and red peony root. Moutan bark clears heat and cools blood, promotes blood circulation and removes blood stasis, while red peony root clears heat and cools blood, disperses blood stasis and relieves pain. They assist the principal herbs in strengthening the effects of clearing heat and purging fire, reducing swelling and relieving pain. At the same time, they work together with acupoints on the body surface such as Jiache and Dicang to dredge local meridians and relieve gum redness, swelling and pain.

[0155] 3.3.1.3.3 Adjuvant: Licorice, which invigorates qi and nourishes the middle jiao, clears heat and detoxifies, harmonizes the effects of other herbs, moderates the cold nature of honeysuckle and dandelion, avoids damage to the spleen and stomach, and also helps relieve oral mucosal irritation.

[0156] 3.3.1.3.4 Medicinal ingredient: Menthol, the volatile oil extracted and incorporated into the ointment, not only guides the active ingredients of the medicine through the meridians and skin, promoting the penetration of the active ingredients of the medicine through the acupoints on the body surface to the internal organs and acupoints, so as to achieve the communication of Qi and blood between the exterior and interior, but also provides a cooling and soothing effect, quickly relieving burning pain in the gums and enhancing the application experience.

[0157] Synergistic Mechanism of Patch + Acupoints (External and Internal Acupoints) + Oral Protection Chewable Tablets: The oral protection chewable tablets are rapidly absorbed through the oral mucosa, quickly relieving acute discomfort such as swollen and painful gums, bad breath, and dry mouth, while cleaning the mouth and providing long-lasting antibacterial effects; the hydrophilic matrix plaster adheres closely to the internal and external acupoints, allowing the active ingredients to quickly penetrate the skin through the acupoints to clear away stomach fire and relieve swollen and painful gums; at the same time, it is conducted through the meridians to the acupoints of the internal organs, clearing away excess heat in the stomach and restoring spleen and stomach function, thus strengthening the body and preventing further complications; the three work together to achieve rapid resolution of external pathogens, harmonization of internal Qi, and simultaneous treatment of both the exterior and interior, preventing further upward attack of stomach fire, and achieving the conditioning goal of "treating the symptoms and preventing further complications, strengthening the body and protecting the gums" during the acute inflammatory period.

[0158] 3.3.2 Yin Deficiency with Hyperactivity of Fire Syndrome (Chronic Oral Discomfort / Mild Symptoms, Corresponding to Yin Deficiency with Internal Heat, Deficiency Fire Rising Upward, and Simultaneous External and Internal Disease Pathogenesis)

[0159] 3.3.2.1 Symptoms: Mild burning pain in the gums, dry mucosa, easy bleeding, accompanied by dry mouth and throat, hot palms and soles, dizziness, tinnitus, insomnia and dreaminess, red tongue with little coating, and thready and rapid pulse; mostly caused by overwork and prolonged illness that depletes yin fluid, leading to yin deficiency and internal heat, with deficiency fire rising to the oral cavity and affecting the meridians on the body surface. It is a common syndrome of chronic oral discomfort, mainly characterized by deficiency of the root and excess of the branch, with both the exterior and interior being affected.

[0160] 3.3.2.2 Targeted Acupoints

[0161] Based on the principle of exterior-interior acupoint pairing, this method combines specific functional acupoints with meridian-based acupoints. It selects acupoints of the internal organs that nourish yin and moisten dryness, promote body fluid production and protect the membranes, along with surface connecting acupoints. It also incorporates the method of pairing acupoints at the shu and mu points and the method of pairing acupoints at the upper and lower parts of the body. The main application areas are the face, lower limbs, and back. The patches are pre-made in sizes of 3cm×3cm (face) and 2.5cm×2.5cm (lower limbs / back) to fit the skin of the acupoints, while also providing a warm and soothing effect.

[0162] 3.3.2.2.1 Core acupoints (internal and external points): Zang-Fu point (Taixi, Sanyinjiao) + surface connecting point / internal and external pivot point (Quanliao, Jiache).

[0163] 3.3.2.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0164] 3.3.2.2.2.1 Treating the root cause: Taixi (the original point of the Kidney Meridian) and Sanyinjiao (the meeting point of the Liver, Spleen and Kidney Meridians) are the root points of the internal organs. They nourish Yin and moisten dryness, generate fluids and nourish blood, directly targeting the core pathogenesis of "Yin deficiency and fire excess", nourishing Yin fluids and clearing away deficiency fire, thus treating the root cause of Yin deficiency;

[0165] 3.3.2.2.2.2 Treating external pathogens: Quanliao (small intestine meridian acupoint) and Jiache (stomach meridian acupoint) are external connecting points on the face. They can dredge local meridians, generate fluids and protect the mucous membrane, and relieve external symptoms such as dry mucous membrane and burning gums.

[0166] 3.3.2.2.2.3 Synergistic Effect of Internal and External Acupoints: The combination of acupoints achieves the same internal and external regulation of the liver, spleen and kidney meridians and facial meridians. It can nourish yin fluids and clear away deficiency fire to strengthen the body, while also dredging local meridians and nourishing mucous membranes to relieve external symptoms, thereby improving chronic oral discomfort and preventing the recurrence of deficiency fire.

[0167] 3.3.2.3 Raw materials and weight ratios for corresponding hydrophilic gel poultices

[0168] 3.3.2.3.1 The Yin-nourishing and dryness-moistening hydrophilic gel patch focuses on "nourishing Yin and moistening dryness, promoting body fluid production and protecting the membrane, and relieving burning pain". It also addresses the root cause of internal ailments and the external symptoms of pathogens. The raw materials are mild and moist, with good transdermal properties, and are suitable for long-term application and conditioning.

[0169] 3.3.2.3.1.1 Weight ratio: 2-4 parts of Solomon's Seal, 1-3 parts of Loquat Extract, 1-2 parts of Mulberry Extract, 1-2 parts of Ophiopogon japonicus, 1-2 parts of Lilium brownii, and 0.5-1 part of Glycyrrhiza uralensis.

[0170] 3.3.2.3.1.2 Matrix formulation (per 100g of ointment): Carbomer 940 6.0-7.0g, hydroxypropyl cellulose 1.0-2.0g, glycerin 22.0-24.0g, propylene glycol 9.0-11.0g, polyethylene glycol 400 2.0-4.0g, azone 1.0-1.2g, triethanolamine 2-2.5g, benzalkonium bromide 0.06-0.08g, purified water to 100g (pH 6.5-7.0, hydrophilic matrix, mild and non-irritating, suitable for sensitive skin and long-term application).

[0171] 3.3.2.4 Patch Compatibility Logic and Mechanism of Action

[0172] 3.3.2.4.1 Principal herbs: Polygonatum odoratum and loquat extract. The two herbs work together to nourish yin and moisten dryness, generate fluids and protect the membrane, directly targeting the core pathogenesis of "yin deficiency and fire excess". They are highly compatible with the "yin-nourishing and blood-nourishing" therapeutic effects of the viscera-specific acupoints such as Taixi and Sanyinjiao, thus treating the interior and strengthening the foundation.

[0173] 3.3.2.4.2 Assistant herbs: Mulberry extract and Ophiopogon japonicus. Mulberry nourishes yin and blood, and promotes the production of body fluids and moistens dryness. Ophiopogon japonicus nourishes yin and promotes the production of body fluids, moistens the lungs and clears the heart. They assist the principal herbs in strengthening the effects of nourishing yin and moistening dryness, promoting the production of body fluids and protecting the oral mucosa. At the same time, they work together with acupoints on the body surface such as Quanliao and Jiache to nourish the oral mucosa and relieve dryness of the mucosa and burning pain of the gums.

[0174] 3.3.2.4.3 Adjuvant herbs: Lily bulb and licorice root. Lily bulb nourishes yin and moistens the lungs, clears the heart and calms the mind, relieves insomnia and dreaminess caused by yin deficiency, and indirectly helps improve oral discomfort; licorice root invigorates qi and replenishes the middle jiao, harmonizes the effects of the herbs, moderates the medicinal properties, and enhances the mildness of the ointment.

[0175] 3.3.2.4.4 Guiding herbs: No single guiding herbs are used. The saliva-generating effects of Polygonatum odoratum and Ophiopogon japonicus are used as a guide to promote the transdermal transmission of the active ingredients of the various herbs, achieving synergistic effects between the exterior and interior, while nourishing the mucous membrane and improving the comfort of the patch.

[0176] Synergistic Mechanism of Patch + Acupoints (Combining Exterior and Interior Acupoints) + Oral Protection Chewable Tablets: The oral protection chewable tablets are rapidly absorbed through the oral mucosa, providing long-lasting nourishment, relieving dry mouth and throat, and mild gum pain, while also freshening breath; the hydrophilic matrix plaster adheres closely to the exterior and interior acupoints, allowing the active ingredients to quickly penetrate the skin through the acupoints to nourish the mucosa, soothe burning pain, and relieve the upward attack of deficiency fire; simultaneously, it is conducted through the meridians to the acupoints of the internal organs, nourishing yin fluids, clearing deficiency fire, and strengthening the body's foundation to prevent further complications; the three work together to achieve "relieving exterior pathogens, nourishing interior qi, and treating both exterior and interior," improving chronic oral discomfort, preventing the recurrence of deficiency fire, and achieving the conditioning goal of "addressing both the symptoms and the root cause, nourishing and protecting the mucosa" in the chronic phase.

[0177] 3.3.3 Spleen and Stomach Deficiency Syndrome (Recurrent Oral Discomfort / Mild Symptoms, Corresponding to Spleen and Stomach Deficiency, Qi and Blood Deficiency, and Simultaneous External and Internal Disease Pathogenesis)

[0178] 3.3.3.1 Symptoms: Pale red gums with persistent dull pain, pale and easily damaged mucosa, accompanied by loss of appetite, abdominal distension, loose stools, fatigue, sallow complexion, pale tongue with white coating, and weak pulse; mostly caused by irregular diet, prolonged illness and physical weakness leading to spleen and stomach deficiency, insufficient production of qi and blood, malnourishment of oral mucosa, and involvement of the body surface meridians. It is a common syndrome in children and people with cold spleen and stomach, mainly due to deficiency of the root, with both exterior and interior diseases.

[0179] 3.3.3.2 Targeted Acupoints

[0180] Based on the principle of exterior-interior acupoint selection, this method combines specific functional acupoints with meridian-based acupoints. It selects acupoints that strengthen the spleen and replenish qi, harmonize the middle jiao and protect the membranes, along with superficial connecting points. It also employs the Shu-Mu acupoint selection method and the distal-proximal acupoint selection method. The main application sites are the abdomen, back, and lower limbs. The patches are pre-made in 4cm×4cm (abdomen / back) and 2.5cm×2.5cm (lower limbs) sizes, adhering gently to the skin at the acupoints without pulling or stretching.

[0181] 3.3.3.2.1 Core acupoints (internal and external points): Zang-Fu point (Zusanli, Pishu) + external connecting point / internal and external pivot point (Zhongwan, Jiache).

[0182] 3.3.3.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0183] 3.3.3.2.2.1 Treating the root cause: Zusanli (the He-Sea point of the Stomach Meridian) and Pishu (the Back-Shu point of the Spleen) are the root points of the internal organs. They strengthen the spleen and replenish qi, harmonize the stomach and nourish blood, directly addressing the core pathogenesis of "spleen and stomach weakness", restoring the spleen and stomach's digestive function and generating qi and blood, thus treating the root cause of spleen and stomach weakness.

[0184] 3.3.3.2.2.2 Treating external pathogens: Zhongwan (stomach mu point) and Jiache (stomach meridian point) are external connecting points. Zhongwan regulates qi and harmonizes the stomach, strengthens the spleen and replenishes qi. Jiache unblocks local meridians and nourishes the oral mucosa, relieving the external symptoms of gum pain and mucosal damage.

[0185] 3.3.3.2.2.3 Synergistic Effect of Internal and External Acupoints: The combination of acupoints harmonizes the internal and external aspects of the spleen and stomach meridians, which not only strengthens the spleen and replenishes qi, generates qi and blood to consolidate the foundation, but also dredges the meridians, nourishes the mucous membrane and relieves external symptoms, improves recurrent oral discomfort, and avoids the decline in mucous membrane repair ability due to insufficient qi and blood.

[0186] 3.3.3.3. Raw materials and weight ratios for corresponding hydrophilic gel poultices

[0187] 3.3.3.3.1 The spleen-strengthening and qi-tonifying hydrophilic gel patch is based on the core functions of "strengthening the spleen and tonifying qi, harmonizing the middle and protecting the membrane, and nourishing the mucous membrane". It also takes into account treating the internal and strengthening the body, and treating the external and eliminating pathogens. The raw materials are mild and moist, with good transdermal properties, and are suitable for long-term application in children and people with cold spleen and stomach.

[0188] 3.3.3.3.1.1 Weight ratio: 2-3 parts licorice, 1-2 parts dried tangerine peel, 1-2 parts amla extract, 1-2 parts yam, 1-2 parts poria cocos, and 0.5-1 part jujube.

[0189] 3.3.3.3.1.2 Matrix formulation (per 100g ointment): Carbomer 940 6.0-7.0g, hydroxypropyl cellulose 1.0-2.0g, glycerin 23.0-25.0g, propylene glycol 8.0-10.0g, polyethylene glycol 400 2.0-4.0g, azone 0.8-1.0g, triethanolamine 2-2.5g, benzalkonium bromide 0.05-0.07g, purified water to 100g (pH 6.5-7.0, hydrophilic matrix, light and mild, no skin irritation, suitable for children's delicate skin).

[0190] 3.3.3.4 Patch Compatibility Logic and Mechanism of Action

[0191] 3.3.3.4.1 Chief herbs: Licorice and dried tangerine peel. The two herbs complement each other, strengthen the spleen and replenish qi, harmonize the middle jiao and regulate qi, directly targeting the core pathogenesis of "spleen and stomach weakness". They are highly compatible with the "strengthening the spleen and harmonizing the stomach" therapeutic effects of the viscera and acupoints such as Zusanli and Pishu, thus treating the root cause of the disease.

[0192] 3.3.3.4.2 Assistant herbs: Phyllanthus emblica extract and Dioscorea opposita. Phyllanthus emblica invigorates qi and nourishes yin, promotes body fluid production and quenches thirst, while Dioscorea opposita invigorates the spleen and stomach, invigorates qi and nourishes yin. These herbs assist the principal herbs in strengthening the spleen and invigorating qi, and nourishing the mucosa. At the same time, they work synergistically with acupoints on the body surface such as Zhongwan and Jiache to nourish the oral mucosa and relieve gum pain and mucosal damage.

[0193] 3.3.3.4.3 Adjuvant herbs: Poria cocos and jujube. Poria cocos strengthens the spleen and eliminates dampness, harmonizes the stomach and calms the mind. Jujube replenishes the middle energizer and qi, nourishes blood and calms the mind. They assist in strengthening the spleen and replenishing qi, improve fatigue and loss of appetite, and provide qi and blood support for the repair of oral mucosa.

[0194] 3.3.3.4.4 Guiding herbs: There is no single guiding herb. The qi-regulating effect of tangerine peel is used as a guide to promote the transdermal transmission of the active ingredients of the various herbs, harmonize the qi of the spleen and stomach, achieve synergistic effect between the exterior and interior, and at the same time enhance the mildness of the ointment, making it suitable for children.

[0195] Synergistic Mechanism of Patch + Acupoints (Combining Exterior and Interior Acupoints) + Oral Protection Chewable Tablets: The oral protection chewable tablets are rapidly absorbed through the oral mucosa, gently nourishing the oral mucosa, promoting mucosal repair, relieving gum pain and mucosal damage, and are also palatable for children, making them convenient to take; the hydrophilic matrix paste adheres closely to the exterior and interior acupoints, and the effective ingredients quickly penetrate the skin through the acupoints to nourish the mucosa, soothe discomfort, and relieve mucosal malnutrition; at the same time, they are conducted through the meridians to the acupoints of the internal organs, strengthening the spleen and replenishing qi, generating qi and blood, and consolidating the foundation to prevent further changes; the three work together to achieve "relieving exterior pathogens, replenishing interior qi, and treating both exterior and interior", improving recurrent oral discomfort, enhancing the mucosal repair capacity, and achieving the conditioning goal of "addressing both the symptoms and the root cause, replenishing qi and protecting the mucosa" during the recurring period.

[0196] 3.3.4 Wind-Heat Invasion Syndrome (Acute Oral Infection Phase / Mild Symptoms, Corresponding to Wind-Heat Invasion, Meridian Disturbance, and Simultaneous External and Internal Disease Pathogenesis)

[0197] 3.3.4.1 Symptoms: Red, swollen and painful gums, accompanied by throat discomfort, dry mouth and tongue, slight burning sensation, fever, slight aversion to wind, headache, nasal congestion, thin yellow tongue coating, and floating and rapid pulse; mostly caused by external wind-heat pathogens that ascend along the meridians to disturb the oral cavity and invade the skin surface. It is a common syndrome of oral discomfort caused by external pathogens, mainly characterized by superficial excess, with both superficial and internal diseases, and a relatively short course of disease.

[0198] 3.3.4.2 Targeted Acupoints

[0199] Based on the principle of exterior-interior acupoint selection, this method combines specific functional acupoints with meridian-based acupoints. It selects acupoints related to clearing heat and relieving exterior symptoms, dispelling wind and eliminating pathogens, along with superficial connecting points. The method also incorporates distal and distal acupoint selection, as well as upper and lower acupoint selection. The main application areas are the neck, face, and hands. The patches are pre-made in 3cm x 3cm (neck / face) and 2cm x 2cm (hand) sizes to fit the acupoints and facilitate movement.

[0200] 3.3.4.2.1 Core acupoints (internal and external points): Zang-Fu point (Hegu, Feishu) + external connecting point / internal and external pivot point (Fengchi, Yingxiang).

[0201] 3.3.4.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0202] 3.3.4.2.2.1 Treating the interior and strengthening the foundation: Hegu (the original point of the large intestine meridian) and Feishu (the back-shu point of the lung) are the original points of the viscera. They clear heat and release the exterior, dispel wind and eliminate evil, directly attacking the core pathogenesis of "external wind-heat attack", promoting lung function and releasing the exterior, clearing away evil heat, and treating the root cause of wind-heat.

[0203] 3.3.4.2.2.2 Treating the exterior and dispelling pathogens: Fengchi (Gallbladder Meridian acupoint) and Yingxiang (Large Intestine Meridian acupoint) are the connecting points on the body surface. Fengchi dispels wind and releases the exterior, and relieves headaches. Yingxiang dispels wind and opens the orifices, and soothes discomfort in the mouth and throat, and relieves wind-heat invading the skin surface and disturbing the surface of the mouth.

[0204] 3.3.4.2.2.3 Synergistic effect between exterior and interior: The combination of acupoints regulates the exterior and interior of the lung and large intestine meridians, which can not only promote lung function and relieve exterior symptoms, clear away pathogenic heat and strengthen the body, but also dispel wind and eliminate pathogens, relieve oral discomfort and relieve exterior symptoms, quickly clear away wind-heat pathogens, and prevent pathogenic heat from penetrating and aggravating oral symptoms.

[0205] 3.3.4.3 Raw materials and weight ratios for corresponding hydrophilic gel poultices

[0206] 3.3.4.3.1 The heat-clearing and exterior-releasing hydrophilic gel patch is based on the core functions of "clearing heat and relieving exterior symptoms, dispelling wind and eliminating pathogens, and providing rapid relief". It also takes into account the internal treatment and strengthening the body's foundation, as well as the external treatment and elimination of pathogens. The raw materials are slightly cool in nature and have good transdermal properties. It is suitable for short-term application to relieve acute external discomfort.

[0207] 3.3.4.3.1.1 Weight ratio: honeysuckle 2-4 parts, light bamboo leaf extract 1-2 parts, menthol 0.5-1.0 parts, forsythia 1-2 parts, platycodon 0.5-1 part, licorice 0.5-1 part.

[0208] 3.3.4.3.1.2 Matrix formulation (per 100g of ointment): Carbomer 940 6.0-7.0g, hydroxypropyl cellulose 1.0-2.0g, glycerin 19.0-21.0g, propylene glycol 8.0-10.0g, polyethylene glycol 400 2.0-4.0g, azone 1.3-1.6g, triethanolamine 2-2.5g (pH 6.0-6.5), benzalkonium bromide 0.07-0.09g, purified water to 100g (pH 6.0-6.5, hydrophilic matrix, cool and breathable, no stuffiness when applied, suitable for neck and hand application).

[0209] 3.3.4.4 Patch Compatibility Logic and Mechanism of Action

[0210] 3.3.4.4.1 Principal herbs: honeysuckle and bamboo leaf extracts. The two herbs work together to clear heat and release the exterior, dispel wind and eliminate pathogens, directly targeting the core pathogenesis of "external wind-heat attack". They are highly compatible with the "clearing heat and releasing the exterior" therapeutic effects of the Zang-Fu organs such as Hegu and Feishu, thus treating the interior and strengthening the body.

[0211] 3.3.4.4.2 Assistant herbs: Forsythia and Platycodon. Forsythia clears heat and detoxifies, dispels wind and dissipates nodules, while Platycodon promotes lung function, soothes the throat, and unblocks meridians. They assist the principal herbs in strengthening the effects of clearing heat and relieving exterior symptoms, dispelling wind and eliminating pathogens. At the same time, they work synergistically with acupoints on the body surface such as Fengchi and Yingxiang to relieve headaches, throat discomfort, and oral redness and swelling.

[0212] 3.3.4.4.3 Adjuvant: Licorice, which clears heat and detoxifies, harmonizes the effects of other herbs, moderates the cold nature of honeysuckle and bamboo leaves, prevents damage to the spleen and stomach, and also helps relieve throat and oral irritation;

[0213] 3.3.4.4.4 Medication: Menthol, extracted volatile oil and incorporated into the ointment, not only guides the active ingredients of the medicine through the meridians and skin, promoting the penetration of the active ingredients of the medicine through the acupoints on the body surface to the internal organs and acupoints, so as to achieve the communication of Qi and blood between the interior and exterior, but also cools and dispels wind, quickly relieving oral burning and throat discomfort, and improving the application experience.

[0214] Synergistic Mechanism of Patch + Acupoints (Combining Exterior and Interior Acupoints) + Oral Protection Chewable Tablets: The oral protection chewable tablets are rapidly absorbed through the oral mucosa, quickly relieving acute symptoms such as oral redness and swelling, throat discomfort, and dry mouth and tongue, while simultaneously cleaning the oral cavity and inhibiting the generation of pathogenic heat; the hydrophilic matrix plaster adheres closely to the exterior and interior acupoints, allowing the active ingredients to quickly penetrate the skin through the acupoints on the body surface to dispel wind and pathogenic factors, soothe discomfort, and relieve external wind-heat; at the same time, it is conducted through the meridians to the acupoints of the internal organs, promoting lung function, relieving exterior symptoms, clearing pathogenic heat, and strengthening the body to prevent further complications; the three work together to achieve "rapid relief of external pathogenic factors, harmony of internal Qi, and simultaneous treatment of exterior and interior," quickly clearing away wind-heat pathogens, blocking the penetration of pathogenic heat, and achieving the conditioning goal of "treating the symptoms and preventing further complications, relieving exterior symptoms and protecting gums" during the acute exogenous disease period.

[0215] 3.3.5 Cold-dampness trapping the spleen syndrome (oral discomfort period / mild symptoms, corresponding to the pathogenesis of cold-dampness trapping the spleen, qi stagnation, and simultaneous exterior and interior disease)

[0216] 3.3.5.1 Symptoms: Mild swelling and dull pain in the gums, sticky mouth and decreased sense of taste, accompanied by epigastric fullness, loss of appetite, loose stools, heaviness in the limbs, white and greasy tongue coating, and a soft and slow pulse; mostly caused by cold food and external cold and dampness leading to cold and dampness trapping the spleen, obstructing the flow of qi, and ascending along the meridians to disturb the oral cavity and affect the meridians on the body surface. It is a common syndrome in middle-aged and elderly people with a cold spleen and stomach, mainly characterized by excess in the superficial aspects, with both superficial and internal diseases.

[0217] 3.3.5.2 Targeted Acupoints

[0218] Based on the principle of exterior-interior acupoint selection, this treatment combines specific functional acupoints with meridian-based acupoints. It selects acupoints that warm the middle jiao (spleen and stomach), dispel cold, resolve dampness, and harmonize the stomach organs, along with superficial connecting points. It also utilizes the Shu-Mu (BL-Mu) and distal-proximal acupoint selection methods. The main application sites are the back, abdomen, and lower limbs. The patches are pre-made in 4cm×4cm (back / abdomen) and 2.5cm×2.5cm (lower limbs) sizes, ensuring a smooth and non-irritating application to the acupoints.

[0219] 3.3.5.2.1 Core acupoints (internal and external points): Zang-Fu point (Spleen Shu, Stomach Shu) + External connecting point / internal and external pivot point (Yinlingquan, Zhongwan).

[0220] 3.3.5.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0221] 3.3.5.2.2.1 Treating the root cause: Spleen Shu (the back-shu point of the spleen) and Stomach Shu (the back-shu point of the stomach) are the root points of the viscera. They warm the middle and dispel cold, resolve dampness and harmonize the stomach. They directly target the core pathogenesis of "cold and dampness trapping the spleen", restore the spleen and stomach's digestive function, resolve cold and dampness, and treat the root cause of cold and dampness trapping the spleen.

[0222] 3.3.5.2.2.2 Treating external pathogens: Yinlingquan (He-Sea point of the Spleen Meridian) and Zhongwan (Mu-Front point of the Stomach Meridian) are external connecting points. Yinlingquan promotes diuresis and eliminates dampness, warms the middle and dispels cold, while Zhongwan regulates qi and harmonizes the stomach, resolves dampness and relieves bloating, thus alleviating the external symptoms of sticky mouth and abdominal fullness.

[0223] 3.3.5.2.2.3 Synergistic effect between exterior and interior: The combination of acupoints regulates the spleen and stomach meridians in a coordinated manner, which not only warms the middle and dispels cold, resolves dampness and strengthens the stomach, but also promotes diuresis and eliminates dampness, regulates qi and relieves bloating, and quickly resolves cold and dampness, avoiding the stagnation of cold and dampness that aggravates oral and spleen and stomach discomfort.

[0224] 3.3.5.3 Raw materials and weight ratios for corresponding hydrophilic gel poultices

[0225] 3.3.5.3.1 The warming and dispersing cold type hydrophilic poultice has the core function of "warming the middle and dispersing cold, resolving dampness and harmonizing the stomach, and relieving stickiness". It also takes into account treating the internal and strengthening the body, and treating the external and eliminating pathogens. The raw materials are mild and moist, with good transdermal properties, and are suitable for middle-aged and elderly people to apply and regulate their condition.

[0226] 3.3.5.3.1.1 Weight ratio: 1-2 parts of perilla leaf extract, 1-2 parts of dried tangerine peel, 1-2 parts of licorice, 0.5-1 part of ginger extract, 1-2 parts of poria cocos, and 1-2 parts of atractylodes macrocephala.

[0227] 3.3.5.3.1.2 Matrix formulation (per 100g ointment): Carbomer 940 6.0-7.0g, hydroxypropyl cellulose 1.0-2.0g, glycerin 22.0-24.0g, propylene glycol 9.0-11.0g, polyethylene glycol 400 2.0-4.0g, azone 1.0-1.2g, triethanolamine 2-2.5g, benzalkonium bromide 0.06-0.08g, purified water to 100g (pH 6.5-7.0, hydrophilic matrix, warm and adherent, moderate viscosity, avoids damage to elderly skin).

[0228] 3.3.5.4. Patch compatibility logic and mechanism of action

[0229] 3.3.5.4.1 Principal herbs: Perilla leaf extract and tangerine peel. The two herbs work together to warm the middle and dispel cold, resolve dampness and harmonize the stomach, directly targeting the core pathogenesis of "cold and dampness trapping the spleen". They are highly compatible with the "warming the middle and resolving dampness" therapeutic effects of the spleen and stomach acupoints such as spleen shu and stomach shu, thus treating the interior and strengthening the foundation.

[0230] 3.3.5.4.2 Assistant herbs: Licorice and ginger extract. Licorice invigorates qi and nourishes the middle jiao, harmonizing the various herbs. Ginger extract warms the middle jiao, dispels cold, and stops vomiting. It assists the principal herbs in strengthening the effects of warming the middle jiao, dispelling cold, resolving dampness, and harmonizing the stomach. At the same time, it works synergistically with acupoints on the body surface such as Yinlingquan and Zhongwan to relieve the stickiness in the mouth and the fullness and discomfort in the stomach and abdomen.

[0231] 3.3.5.4.3 Adjuvant herbs: Poria cocos and Atractylodes macrocephala. Poria cocos promotes diuresis and eliminates dampness, strengthens the spleen and stomach, while Atractylodes macrocephala strengthens the spleen and replenishes qi, dries dampness and promotes diuresis. They help to resolve cold and dampness in the body and promote the expulsion of cold and dampness from the lower abdomen, treating both the exterior and interior.

[0232] 3.3.5.4.4 Guiding herbs: There are no single guiding herbs. The qi-regulating effect of tangerine peel is used as a guide to promote the transdermal transmission of the effective components of the various herbs, harmonize the qi mechanism of the spleen and stomach, achieve synergistic effect between the exterior and interior, and at the same time enhance the moisturizing properties of the ointment, making it suitable for use by the elderly.

[0233] Synergistic Mechanism of Patch + Acupoints (Combining Exterior and Interior Acupoints) + Oral Protection Chewable Tablets: The oral protection chewable tablets are rapidly absorbed through the oral mucosa, quickly relieving discomfort such as oral stickiness and decreased taste, while gently cleaning the mouth and harmonizing the spleen and stomach's Qi. The hydrophilic matrix plaster adheres closely to the exterior and interior acupoints, allowing the active ingredients to quickly penetrate the skin through the acupoints, warming the middle Jiao, dispelling cold, resolving dampness and bloating, and relieving cold and dampness trapping the spleen. At the same time, it is conducted through the meridians to the acupoints of the internal organs, warming the middle Jiao, resolving dampness, restoring spleen and stomach function, and strengthening the body's foundation to prevent further deterioration. The three work together to achieve "relieving exterior pathogens, harmonizing interior Qi, and treating both exterior and interior," resolving cold and dampness in the body, improving oral and spleen and stomach discomfort, and achieving the conditioning goal of "addressing both the root cause and symptoms, resolving dampness and protecting the gums" during the cold and dampness period.

[0234] 3.4 Composition, Function, and Differentiated Design of Hydrophilic Gel Poultice Matrix

[0235] 3.4.1 Matrix composition and function

[0236] This invention uses a hydrophilic polymer material as a matrix carrier, combined with indication-specific herbal extracts, to form a breathable, gentle, and long-lasting sustained-release patch system. Specifically: Carbomer 940 serves as the main gel skeleton material, swelling upon contact with water and then neutralized by triethanolamine to form a high-viscosity hydrogel, providing the patch's core shapeability, cohesion, and adhesion, ensuring the paste does not drip, detach, or string, resulting in a firm application and no residue upon removal; Hydroxypropyl cellulose acts as an auxiliary thickener, water-retaining, and coating-improving component, enhancing matrix viscosity and water retention, improving coating processability, making the paste softer and smoother, reducing facial skin pulling sensation, and improving application comfort; Glycerin, propylene glycol, and... Polyethylene glycol 400 is compounded to form a triple moisturizing and lubricating system, preventing the ointment from drying and cracking, maintaining gel spreadability, and assisting in the stability and release of active ingredients, thus prolonging the application time. Azone, as a safe transdermal penetration enhancer, promotes the penetration of herbal extracts through acupoints and enhances the targeted conditioning effect. Triethanolamine is used to neutralize the acidity of carbomer, adjust the pH of the matrix to the skin's suitable range, reduce irritation, and ensure the matrix's stable formation. Benzalkonium bromide has antibacterial and preservative properties, ensuring the stability and safety of the formulation during storage and use.

[0237] The resulting matrix is ​​highly hydrophilic, breathable, mildly adhesive, and highly skin-compatible, without the irritation and sensitization risks of traditional rubber plasters, making it suitable for long-term application to sensitive skin, children, and the elderly. It is stable in shape and evenly coated, and can be adapted to various acupoint patch sizes such as 3cm×3cm, 2.5cm×2.5cm, and 4cm×4cm, meeting the needs of acupoint application on multiple areas such as the face, around the mouth, back, abdomen, and lower limbs. It is especially suitable for acupoint application on delicate facial skin such as the cheekbone and the Dicang acupoint, enabling continuous transdermal release of active ingredients and prolonging the soothing effect.

[0238] 3.4.2 Adjustment based on population differences

[0239] 3.4.2.1 Children's version: Made with a light base, reducing the amount of cold and irritating extracts, it is gentle and safe, suitable for children's delicate skin.

[0240] 3.4.2.2 Adult version: The proportion of heat-clearing and soothing ingredients is appropriately increased to enhance the targeted swelling-reducing and pain-relieving effects.

[0241] 3.4.2.3 For the elderly / sensitive skin: Optimize the adhesiveness and extensibility of the matrix, reduce skin traction, increase moisturizing and nourishing ingredients, and improve fit, comfort and tolerance.

[0242] The significant technical effects and advancements brought about by this invention are reflected in:

[0243] This composition utilizes the synergistic effects of three components: oral protective chewable tablets, oral protective toothpaste, and topical acupoint water-based gel patch. Based on the traditional Chinese medicine theory of "treating both internal and external factors, emphasizing both cleansing and nourishing, and addressing both the root cause and symptoms," and combined with modern oral pathology and acupoint targeted drug delivery mechanisms, it exerts a multi-dimensional, multi-level, and multi-target effect on oral health protection, from local cleaning, long-lasting antibacterial action, and mucosal repair to meridian regulation and symptom relief.

[0244] 1. Cleans and inhibits bacteria, establishing the first line of defense for oral health.

[0245] Oral-specific protective toothpaste uses a food-grade cleaning matrix and active ingredients derived from both food and medicine to effectively clean the tooth surface, interdental spaces, and gum line during brushing. It removes food debris and extrinsic plaque, inhibits the growth of oral pathogens, and reduces the formation of plaque, soft deposits, and tartar, laying a foundation for oral health protection.

[0246] 3. Long-lasting antibacterial effect and maintenance of oral microecological balance

[0247] Oral protection chewable tablets contain extracts of honeysuckle, magnolia bark, clove, etc. Through antibacterial, anti-adhesion, and flora-regulating effects, they inhibit cariogenic bacteria, Porphyromonas gingivalis, and other harmful bacteria, maintain the stability of the oral microecology, reduce the sources of bad breath, and achieve long-term protection and continuous maintenance.

[0248] 4. Protects gums and oral mucosa, repairs oral mucosa

[0249] The chewable tablets and toothpaste contain extracts of licorice, Solomon's seal, and loquat, which can gently protect the oral mucosa, relieve dryness, improve the fragile state of the mucosa, reduce discomfort such as recurrent oral ulcers, gingival bleeding, and mucosal burning, and enhance the oral mucosal barrier function.

[0250] 5. Freshens breath and improves the source of oral odor

[0251] Ingredients such as peppermint, monk fruit, amla, and cranberry can quickly neutralize bad breath and improve the sticky feeling of breath through multiple pathways such as volatilization, antibacterial action, and humidity regulation, thus achieving fresh breath and long-lasting fragrance.

[0252] 6. Prevents tooth decay, protects enamel, and strengthens tooth health.

[0253] The chewable tablets contain xylitol, magnolia bark, clove and other ingredients that work together to prevent tooth decay. The toothpaste contains food-grade hydrated silica and plant extracts that work together to strengthen enamel protection, reduce demineralization, and lower the risk of tooth decay, root caries and enamel wear.

[0254] 7. Acupoint-targeted soothing and rapid relief of redness, swelling, and pain.

[0255] The topical acupoint water-based gel patch is formulated according to different syndromes of oral discomfort (excessive stomach fire, yin deficiency with fire excess, spleen and stomach weakness, wind-heat invasion, cold-dampness trapping the spleen). By applying the patch to acupoints such as Jiache, Dicang, Neiting, Zusanli, and Taixi, it can dredge the meridians, target pain relief, reduce redness, swelling and pain of the gums, and quickly relieve discomfort symptoms.

[0256] 8. Regulates the internal organs and meridians, promoting the smooth flow of Qi throughout the body.

[0257] Combining traditional Chinese medicine meridian theory, the Babu patch penetrates acupoints to affect the flow of qi and blood in the meridians, and works synergistically with chewable tablets to regulate the functions of the liver, spleen, stomach, heart and other organs, so that local oral inflammation and the overall condition can be improved simultaneously, achieving an oral protection system that "treats both the local and the whole, and addresses both the symptoms and the root cause".

[0258] 9. Suitable for all age groups, safe for long-term use.

[0259] This composition is mainly made of food and medicine ingredients. It is mild, low in irritation, and palatable. The formula can be customized according to different ages and physical conditions, such as children, adolescents, adults, the elderly, and sensitive groups. It has a high safety factor and is suitable for long-term continuous use.

[0260] In summary, this oral protection composition achieves a closed-loop system of six major functions—cleaning, antibacterial, gum protection, repair, soothing, and conditioning—through a three-component approach: oral administration, local cleaning, and external acupoint application. It has significant advantages such as a clear mechanism of action, high safety, wide applicability, comprehensive application scenarios, and long-term reliability. It can be widely used in daily oral care, oral sensitivity care, conditioning for people prone to inflammation, and as a daily protective measure for families of all ages.

[0261] III. Preparation method of the composition

[0262] 1. Preparation method of oral protective chewable tablets

[0263] This method is based on the theory of food and medicine sharing the same origin, combined with the chewing and mucosal absorption characteristics of oral protection chewable tablets. It optimizes the core formula to address the different symptoms of oral discomfort, achieving the effects of "rapid relief, organ regulation, and oral protection." The specific preparation steps are as follows:

[0264] 1.1 Raw material preparation

[0265] 1.1.1 Core raw materials: Weigh the core medicinal and edible raw materials according to the corresponding weight ratios for each of the aforementioned syndrome types. All raw materials should comply with the relevant standards of the Pharmacopoeia of the People's Republic of China and the National Catalogue of Medicinal and Edible Substances, and remove impurities and moldy parts to ensure the purity and safety of the raw materials.

[0266] 1.1.2 Preparation of auxiliary materials:

[0267] 1.1.2.1 Fillers and molding excipients: sorbitol, xylitol, maltitol (total amount is about 2 to 3 times the total weight of the core raw materials), microcrystalline cellulose (adhesive filler, added amount is 10% to 20% of the total weight of the core raw materials), magnesium stearate (lubricant, added amount is 0.5% to 1.0% of the total weight of the dried medicinal powder);

[0268] 1.1.2.2 Functional excipients: Glycerin (humectant, added in small amounts), sodium carboxymethyl starch (disintegrant, promotes rapid dissolution and absorption after chewing, added at 5% to 8% of the total weight of the core raw materials);

[0269] 1.1.2.3 Flavoring and seasoning ingredients: menthol or natural peppermint oil (for flavoring, cooling and soothing, suitable for oral discomfort), citric acid (for flavoring and improving taste), natural edible flavorings (such as citrus flavoring, peppermint flavoring, optional). All flavoring ingredients meet food-grade or pharmaceutical-grade standards.

[0270] 1.2 Extraction and Purification

[0271] 1.2.1 Raw material pretreatment: Remove impurities, moldy parts and mud from the above core raw materials (excluding raw materials containing volatile components, such as peppermint and dried tangerine peel), wash them clean, and dry them at a low temperature of ≤60℃ until the moisture content is ≤8%. After pulverizing, pass them through an 80-100 mesh sieve to obtain a fine powder of mixed medicinal materials for later use. Raw materials containing volatile components are pulverized separately, passed through an 80-100 mesh sieve, and set aside separately (in order to retain their volatile active ingredients to the maximum extent and avoid loss during the extraction process).

[0272] 1.2.2 Extraction of active ingredients: Place the above-mentioned mixed medicinal powder into an extraction device, add 8 to 12 times the amount of purified water, soak for 30 minutes, and then extract for 1 to 2 hours using a low-temperature extraction method (extraction temperature 40 to 50℃). After extraction, filter and collect the filtrate; add 5 to 6 times the amount of purified water to the filter residue and repeat the extraction once. Combine the two filtrates and filter them through a 200-mesh sieve to obtain the initial filtrate.

[0273] 1.2.3 Concentration: The initial filtrate is concentrated under reduced pressure at 60-70℃ and a vacuum of 0.06-0.08MPa to a thick extract with a relative density of 1.10-1.20 (measured at 60℃);

[0274] 1.2.4 Drying: The thick extract is spray-dried or vacuum-dried to make a dry extract powder with a moisture content of ≤5% for later use.

[0275] 1.3 Mixing and Granulation

[0276] 1.3.1 Premixing: The extract powder obtained in step two, the separately prepared fine powder of volatile components, and excipients such as sorbitol, xylitol, maltitol, microcrystalline cellulose, and sodium carboxymethyl starch are placed in a mixer and mixed at room temperature for 15 to 20 minutes to ensure that the materials are initially mixed evenly.

[0277] 1.3.2 Granulation: Add an appropriate amount of purified water or glycerol solution to the mixture and stir to form a soft material. The soft material should be able to "crumb when squeezed in the hand and crumble when lightly pressed". Granulate the soft material through an 18-20 mesh sieve to obtain wet granules.

[0278] 1.3.3 Drying: Place the wet granules in a low-temperature drying oven and dry them at 50-60℃ until the moisture content is ≤5%. After drying, granulate them through a 16-18 mesh sieve to remove oversized or undersized granules and obtain uniform dry granules.

[0279] 1.3.4 Total Mixing: Add magnesium stearate, menthol, citric acid, food flavoring and other remaining excipients to the dry granules, put them into a mixer and mix at room temperature for 10 to 15 minutes to ensure that the excipients and dry granules are mixed evenly, and set aside.

[0280] 1.4 Tableting and Post-processing

[0281] 1.4.1 Tableting: Place the mixed granules into a tableting machine, adjust the tableting parameters, and compress them into chewable tablets of the specified size and shape (such as round or oval). The weight of a single tablet is controlled at 1.0 to 2.0 g / tablet (preferably 1.5 g ± 0.1 g), and the tablet thickness is controlled at 2-3 mm to ensure that the tablets have moderate hardness, are not easily broken, and dissolve easily after chewing.

[0282] 1.4.2 Screening: Remove tablets that are irregular in shape, have excessive weight differences, have unacceptable hardness, or have obvious defects.

[0283] 1.4.3 Packaging: Qualified tablets should be immediately individually sealed in aluminum foil bags or blister packs (e.g., 10 tablets per blister pack, 3 blister packs per box) to prevent moisture absorption, oxidation, and loss of active ingredients. The outer packaging should indicate the product type, target population, usage instructions, production date, and shelf life.

[0284] 1.5 Key Process Points and Precautions

[0285] 1.5.1 Environmental Control: The cleanliness of the environment is controlled throughout the preparation process to avoid the introduction of impurities and ensure the hygiene and safety of the product; the tableting and packaging processes must be carried out in a clean environment that meets food-grade or pharmaceutical-grade cleanliness standards.

[0286] 1.5.2 Temperature control: The temperature of the drying and extraction processes is strictly controlled (≤60℃ for core processes). Low-temperature operation can maximize the retention of bioactive components such as flavonoids and saponins and volatile components in the raw materials and prevent the loss of effective components. The tableting process is carried out at room temperature to avoid softening of excipients due to high temperature.

[0287] 1.5.3 Moisture control: The moisture content of the extract powder should be ≤5%, the moisture content of the dry granules should be ≤5%, and the moisture content of the final product should be ≤3% to ensure the stability, chewability, and shelf life of the chewable tablets.

[0288] 1.5.4 Uniformity control: Ensure that the extract powder and excipients are mixed evenly, and granulate after granulation to ensure that the content of active ingredients in each chewable tablet is uniform and to avoid local differences in color, taste or efficacy.

[0289] 1.5.5 Retention of active ingredients: Raw materials containing volatile components are crushed and added separately to avoid the destruction of their volatile active ingredients by high-temperature extraction, thus ensuring efficacy and optimizing the natural flavor and taste of the product.

[0290] 2. Preparation method of oral protective toothpaste

[0291] 2.1 Raw material preparation

[0292] 2.1.1 Core Efficacy Ingredients: Based on the corresponding weight ratios for each target population, extracts of medicinal and edible substances and functional fruit extracts (honeysuckle extract, amla extract, cranberry extract, licorice extract, Solomon's seal extract, loquat extract, etc.) are weighed out. All ingredients comply with the relevant standards of the *Pharmacopoeia of the People's Republic of China*, the *National Food Safety Standard for Raw Materials Used in Toothpaste*, and the National Catalogue of Medicinal and Edible Substances. They are free of impurities, mold, and off-odors, with food-grade extracts being preferred. The amla extract is selected in dry powder form, and the cranberry extract is a standardized extract or cranberry powder with a proanthocyanidin content ≥5%. Microencapsulation technology is used as needed to ensure pigment stability.

[0293] 2.1.2 General matrix excipients (per 100g of paste): 8-12g of food-grade hydrated silica (ultra-fine soft particles for children's formula, low-hardness particles for elderly formula, and regular rounded particles for general population and women's formula), 35-45g of purified water, 15-20g of glycerin, 1.0-1.5g of sodium carboxymethyl cellulose, 2.0-5.0g of xylitol (adjust dosage according to population type), 1.5-2.5g of sodium lauroyl sarcosinate, 0.01-0.05g of disodium edetate, and 0.05-0.1g of natural antioxidants. No synthetic preservatives, artificial colors, or synthetic fragrances are added.

[0294] 2.1.3 Adjustment of Differentiated Excipients:

[0295] 2.1.3.1 Children's Formula: Added orange extract and strawberry extract (0.3-0.5g each, corresponding to an addition amount of 0.3%-0.5%); excluding dandelion extract, perilla leaf extract, and grapefruit extract; licorice extract 0.4%-0.6%, honeysuckle extract 0.1%-0.2%, amla extract and cranberry extract 0.1%-0.2%; food-grade hydrated silica is made of ultrafine soft particles; sodium lauroyl sarcosinate 1.5-2.0g; glycerin can be increased to 18-22g; xylitol 3.0%-5.0%; menthol 0.3%-0.5%, ensuring gentleness and non-irritation, suitable for children's spleen, stomach, and oral mucosa, while reducing the risk of accidental swallowing.

[0296] 2.1.3.2 Women's Formula: Dandelion extract (0.2%–0.3%) and kiwi extract (0.2%–0.3%) may be added; perilla leaf extract is not added; licorice extract 0.3%–0.5%, honeysuckle extract 0.2%–0.4%, amla extract and cranberry extract 0.3%–0.5%; food-grade hydrated silica uses regular rounded particles; sodium lauroyl sarcosinate 2.0–2.5g; xylitol 2.0%–3.0%; menthol 0.5%–0.8%; suitable for the oral environment of women during menstruation and pregnancy, enhancing antioxidant and gum-protecting effects.

[0297] 2.1.3.3 Formula for the Elderly: Increases the content of Polygonatum odoratum extract (0.3%–0.4%), loquat extract (0.8%–1.0%), monk fruit extract (0.1%–0.15%), and perilla leaf extract (0.2%–0.3%); excludes dandelion extract; licorice extract 0.4%–0.6%, honeysuckle extract 0.2%–0.3%, amla extract and cranberry extract 0.2%–0.4%; food-grade hydrated silica uses low-hardness particles; glycerin content can be increased to 18–22g; xylitol content 2.0%–3.0%; menthol content 0.3%–0.5% to relieve dry mouth and is suitable for those with fragile mucous membranes and sensitive teeth.

[0298] 2.1.3.4 General Population Formula: Dandelion extract (0.2%–0.4%) and Magnolia officinalis extract (0.1%–0.3%) can be added; Perilla frutescens leaf extract (0.1%–0.3%) is optional; Licorice extract (0.2%–0.4%), Honeysuckle extract (0.3%–0.5%), Phyllanthus emblica extract, and Cranberry extract (0.3%–0.5%) are also included; Food-grade hydrated silica uses regular rounded particles; Sodium lauroyl sarcosinate (2.0–2.5g), Xylitol (2.5%–4.0%), and Menthol (0.6%–1.0%) are used. This formula is suitable for daily oral hygiene needs, providing antibacterial, freshening, and gum-protecting effects.

[0299] 2.2 Pretreatment of core extracts

[0300] 2.2.1 Raw material pretreatment: Remove impurities and mud from the core medicinal and edible raw materials such as honeysuckle, amla, and cranberry. After washing, dry them at a low temperature of ≤60℃ until the moisture content is ≤8%. After pulverizing, pass them through an 80-100 mesh sieve to make a fine powder of mixed medicinal materials for later use. Volatile components such as menthol are pulverized and sieved separately and stored separately to avoid loss of active ingredients due to high temperature.

[0301] 2.2.2 Extraction of active ingredients: Place the mixed medicinal powder into the extraction equipment, add 8 to 12 times the amount of purified water and soak for 30 minutes, extract at a low temperature of 40 to 50°C for 1 to 2 hours, filter and collect the filtrate; add 5 to 6 times the amount of purified water to the filter residue and repeat the extraction once, combine the two filtrates, and filter through a 200-mesh sieve to obtain the initial filtrate.

[0302] 2.2.3 Concentration and Drying: The initial filtrate is concentrated under reduced pressure at 60-70℃ and a vacuum degree of 0.06-0.08MPa to a thick extract with a relative density of 1.10-1.20 (measured at 60℃); the thick extract is then processed into extract powder by spray drying or vacuum drying, with the moisture content controlled to ≤5%; the fine powder of volatile components is mixed evenly with the extract powder to obtain the core efficacy powder.

[0303] 2.3.4 Differentiated formulation: Based on the formulation requirements of each population group, the proportion of each component in the core efficacy powder is precisely adjusted. The dosage of cooling ingredients such as honeysuckle extract is reduced in children's and elderly formulas. The dosage of licorice extract (0.4% to 0.6%) and xylitol (3.0% to 5.0%) is increased in children's formulas. The dosage of moisturizing ingredients such as Solomon's seal and loquat is increased in elderly formulas. The dosage of antioxidant components such as mulberry and kiwi is strengthened in women's formulas. The dosage of general population formulas maintains a balanced proportion of each component to ensure suitability for the physiological characteristics and needs of each population group.

[0304] 2.3 Preparation of Paste

[0305] 2.3.1 Aqueous phase preparation: Place purified water, glycerin, sodium carboxymethyl cellulose, disodium edetate, and natural antioxidant into a mixing tank and stir at room temperature for 15-20 minutes until the sodium carboxymethyl cellulose is completely dissolved and the system is transparent and free of particles. For children's and elderly people's products, the amount of glycerin can be increased (to 18-22g) to enhance the moisturizing effect and prevent dry mouth.

[0306] 2.3.2 Powder preparation: Food-grade hydrated silica, xylitol, and core functional powder are placed in a mixer and mixed at room temperature for 10-15 minutes to ensure that all components are mixed evenly, without lumps or stratification; during the mixing process, according to the needs of the target population, corresponding natural fruit extracts and auxiliary raw material powders (such as dandelion, kiwi extract, etc.) are added.

[0307] 2.3.3 Mixing and Emulsification: Slowly add the powder phase to the aqueous phase while stirring (stirring speed 800-1200 rpm) for 20-30 minutes to fully integrate the powder and aqueous phases; then add sodium lauroyl sarcosinate and continue stirring for 10-15 minutes to ensure uniform dispersion of the foaming agent; the stirring speed can be appropriately reduced (800-1000 rpm) for children's formula to prepare a low-foaming system, while other formulas should be stirred at the normal speed.

[0308] 2.3.4 Homogenization and Defoaming: Transfer the mixed and emulsified materials to a homogenizing emulsifier and homogenize at a medium-low speed (100-2000 rpm) for 10-30 minutes to ensure the paste is uniform and fine; then transfer the materials to a vacuum defoaming tank and defoam at a vacuum of -0.08 to -0.09 MPa for 15-20 minutes to remove air bubbles and prevent air bubble residue from occurring during subsequent filling.

[0309] 2.3.5 Fragrance and Color Adjustment: After pre-dissolving menthol in a small amount of ethanol, add it to the defoamed paste along with natural fruit extracts and stir for 5-10 minutes to ensure a uniform aroma. If color adjustment is required, add natural coloring ingredients such as mulberry extract and stir well, avoiding the use of artificial colorings. Adjust the amount of menthol according to the needs of different groups: 0.3%-0.5% for children's and elderly formulas, 0.5%-0.8% for women's formulas, and 0.6%-1.0% for general population formulas, to meet the taste preferences of different groups. At the same time, increase the amount of fruit extracts in the children's formula to mask the herbal flavor.

[0310] 2.3.6 Curing: Place the prepared paste in a constant temperature curing chamber and cure it for 24 to 48 hours at 25℃±2℃ and relative humidity of 40% to 50% to make the paste viscosity reach 200 to 300 Pa·s, ensuring the stability of the paste and avoiding separation or water seepage.

[0311] 2.4 Filling and Post-processing

[0312] 2.4.1 Filling: A vacuum filling machine is used to fill the matured toothpaste into toothpaste tubes of the corresponding size. The filling speed is controlled at 50-80 tubes / minute to ensure that the filling amount of each tube of toothpaste has an error of ≤±0.1g. Small toothpaste tubes are used for children's toothpaste to suit children's usage habits and avoid toothpaste contamination and air bubbles during the filling process.

[0313] 2.4.2 Sealing: The toothpaste tubes are sealed using a sealing machine. The sealing temperature is controlled at 180-200℃ to ensure that the sealing meets the standards and there is no leakage. After sealing, the toothpaste tubes are shaped to ensure a neat appearance.

[0314] 2.4.3 Screening: Remove unqualified products with uneven filling, poor sealing, air bubbles in the paste, or damaged appearance to ensure that the quality of the finished product meets the standards.

[0315] 2.4.4 Packaging and Warehousing: Qualified toothpaste is classified according to target groups and packaged in cardboard boxes. The outer packaging indicates the target group, applicable population, usage method, core ingredients, production date and shelf life.

[0316] 2.5 Key Process Points and Precautions

[0317] 2.5.1 Environmental control: The entire process of preparation, filling and packaging must be carried out in an environment that meets food-grade cleanliness standards. Equipment must be cleaned and disinfected before use to avoid the introduction of impurities and microorganisms. Filling machines, mixing tanks, homogenizers and other equipment must be maintained and serviced regularly.

[0318] 2.5.2 Temperature control: The temperature of core processes such as extract drying and extraction is ≤60℃ to avoid loss of active ingredients; the maturation and filling of the paste are carried out at room temperature to prevent the paste from deteriorating or becoming abnormally viscous due to high temperature.

[0319] 2.5.3 Uniformity control: The core functional powder and excipients are mixed evenly, and the paste is fully homogeneous to avoid uneven concentration of ingredients in certain areas; the formulation ratios for different groups of people are precisely differentiated to avoid confusion.

[0320] 2.5.4 Stability Control: Amla extract is rich in polyphenols and is easily oxidized, so it needs to be combined with natural antioxidants (such as vitamin E) and should be kept away from strong alkaline substances; cranberry extract needs to be encapsulated using microencapsulation technology to prevent pigment loss and discoloration of the cream; sodium carboxymethyl cellulose needs to be fully swollen to avoid affecting the cream's shape and stability; the dosage of all raw materials must strictly follow the prescribed range, and the dosage of different formulas should be precisely adjusted according to the needs of different user groups to avoid affecting the stability of the cream and the user experience.

[0321] 2.5.5 Safety Control: All raw materials are food-grade and strictly comply with the "National Food Safety Standard for Raw Materials Used in Toothpaste". The children's and elderly versions have reduced amounts of cooling and irritating ingredients. The children's version uses ultra-fine soft hydrated silica and a low-foaming formula to ensure that there is no safety hazard if a child accidentally swallows a small amount. The women's version removes all potentially risky ingredients and is suitable for use by women during menstruation and pregnancy. The elderly version has reduced abrasive hardness to avoid irritating the fragile gums and mucous membranes.

[0322] 3. General preparation method for five types of hydrophilic gel patch formulations for external acupoint application.

[0323] This method is applicable to the preparation of hydrophilic gel patch for external acupoint application for the aforementioned five syndrome types. It employs a modular design, and based on a general matrix preparation process, achieves standardized production of the five functional patches by replacing different types of active Chinese herbal ingredients. This approach balances efficacy stability, good skin compatibility, and industrial feasibility.

[0324] The specific steps are as follows:

[0325] 3.1 Raw material preparation

[0326] 3.1.1 Core Raw Materials

[0327] Weigh out each medicinal and edible or commonly used Chinese herbal raw material according to the weight ratio corresponding to the aforementioned syndrome type. All raw materials meet the relevant standards of the Pharmacopoeia of the People's Republic of China and the National Catalogue of Medicinal and Edible Substances, and are free of impurities, mold, and off-odors.

[0328] 3.1.2 Preparation of auxiliary materials

[0329] 3.1.2.1 General base (based on 100g of ointment):

[0330] Core matrix: Carbomer 940: 6.0-7.0g, hydroxypropyl cellulose (1.0-2.0g, added as needed, adjusted according to the corresponding ratio for each syndrome), glycerin (pharmaceutical grade, 18.0-22.0g), propylene glycol 8.0-12.0g;

[0331] 3.1.2.2 Functional excipients: Kaolin / Magnesium Aluminum Silicate 3-5g (filler and thickener), Polyethylene Glycol 400 2.0-4.0g (plasticizer, improves the dissolution rate of active ingredients), Azone 0.5-1.5g (transdermal penetration enhancer), Triethanolamine (appropriate amount, pH adjuster, adjust to 6.0-7.0);

[0332] 3.1.2.3 Preservative and stabilizing excipients: Ethylparaben / phenoxyethanol 0.1-0.3g (preservative), benzalkonium bromide (0.05-0.09g can be used as an alternative, preservative), disodium edetate 0.01-0.05g (metal ion chelating agent);

[0333] 3.1.2.4 Other excipients: Lanolin (to improve the adhesion of the patch, reduce skin irritation, and promote blood circulation; add to 2-3g for related syndromes), medical petroleum jelly (for periorbital application; add to 1-2g), purified water to make up to 100g;

[0334] 3.1.2.5 General permeability-enhancing and flavor-correcting excipients: borneol / menthol (0.1-0.5g, for permeability enhancement, cooling and soothing), or can be added at 0.1-0.5 parts of the total weight of the core raw materials, all of which meet medical-grade standards.

[0335] 3.1.2.6 Carrier accessories: medical non-woven fabric backing, polyethylene release paper (medical protective film), suitable for adhesive application, ensuring firm application and easy peeling, with no adhesive residue.

[0336] 3.2 Stepwise preparation method

[0337] 3.2.1 Preparation of active ingredients (dry ointment / powder) (applicable to all types)

[0338] 3.2.1.1 Raw material pretreatment: Each type of medicinal material is cleaned and washed to remove impurities and mud. It is then dried at a low temperature below 60℃, pulverized after drying, and passed through an 80-100 mesh sieve to obtain a fine powder of mixed medicinal materials for later use. Borneol / menthol is ground into a fine powder and set aside separately.

[0339] 3.2.1.2 Extraction of active ingredients: Place the mixed medicinal powder into the extraction equipment, add 8 to 10 times the amount of purified water, soak for 30 minutes, heat to 85 to 95℃ (can be finely adjusted to 90 to 95℃) and reflux extract twice, each time for 1 to 1.5 hours; combine the two extracts and filter through a 200-mesh sieve to obtain the initial filtrate; for medicinal materials containing volatile components (such as peppermint, tangerine peel) or high fat-soluble components, CO2 supercritical extraction or ethanol reflux extraction can be used first as needed, and the resulting extract is added later.

[0340] 3.2.1.3 Concentration: The initial filtrate is concentrated under reduced pressure at 60-65℃ and a vacuum of -0.06 to -0.085 MPa to a thick extract with a relative density of 1.10-1.25 (measured at 60℃) for later use; alternatively, it can be concentrated at 60℃ and a vacuum of 0.06-0.08 MPa to a relative density of 1.15-1.20 (measured at 25℃).

[0341] 3.2.1.4 Drying: The thick extract is spray-dried (inlet air temperature 160-180℃, outlet air temperature 80-90℃), vacuum belt dried, or vacuum freeze-dried (drying temperature ≤60℃), pulverized and passed through an 80-100 mesh sieve to make a dry extract powder; add the prepared borneol / menthol fine powder, mix evenly, and control the moisture content of the dry powder to ≤5.0% for later use.

[0342] 3.2.2 Preparation of a universal gel matrix

[0343] 3.2.2.1 Swelling: Carbomer 940 and hydroxypropyl cellulose (added as needed) are evenly and slowly added to purified water accounting for about 40% of the total water volume while stirring. The mixture swells at room temperature for 24 hours, or is heated to 50-60℃ to accelerate swelling until it is completely transparent and free of particles, thus preparing a carbomer gel matrix.

[0344] 3.2-2.2 Dissolution and dispersion of excipients: Mix glycerin, propylene glycol, polyethylene glycol 400, lanolin (and the corresponding micro-adjustment excipients required for the treatment, such as medical petroleum jelly), heat to 45-55°C, and stir until completely melted and mixed evenly; while stirring, add the mixture to the carbomer swelling solution in sequence and stir evenly.

[0345] 3.2.2.3 Neutralization and Homogenization: Triethanolamine is slowly added dropwise while stirring, and the pH value is adjusted to 6.0-7.0. The system gradually changes from a solution to a transparent, fine, and thick hydrophilic composite matrix. The above gel matrix is ​​transferred to a homogenizer and homogenized at low speed for 3-5 minutes to make it more uniform and fine. It is then cooled to room temperature for later use.

[0346] 3.2.2.4 Preservative treatment: Add ethylparaben / phenoxyethanol (or benzalkonium bromide) and disodium edetate, stir for 5-10 minutes to ensure uniform dispersion of preservatives and metal ion chelating agents, and prevent deterioration of the preparation.

[0347] 3.2.3 Preparation, defoaming, and application of various types of pastes

[0348] 3.2.3.1 Ointment Mixing: According to the prescription ratio, slowly add the corresponding dry ointment powder, azone, borneol / menthol (pre-dissolved with a small amount of ethanol), etc., to the prepared general gel matrix. Stir continuously for 20-30 minutes with a stirring device (which can be combined with homogenization) to ensure that the dry powder and matrix are mixed evenly and without lumps, forming an ointment with uniform color and moderate viscosity.

[0349] 3.2.3.2 Homogenization and Defoaming: Homogenize the mixture in a homogenizer at a low to medium speed (1000-2000 rpm) for 10-30 minutes to ensure that the active ingredients and the matrix are completely integrated and free of particles; then transfer the homogenized paste to a vacuum defoaming tank and defoam at a vacuum of -0.08 to -0.09 MPa for 15-20 minutes until the paste is smooth and free of visible bubbles.

[0350] 3.2.3.3 Coating and Forming: Adjust the blade distance of the coating machine to evenly apply the defoamed paste onto the medical non-woven fabric backing; the coating thickness is set according to the application area: trunk / limbs type (sizes 5cm×7cm, 7cm×10cm or 3cm×4cm, 4cm×4cm) approximately 0.3~0.5mm (can be finely adjusted to 1.0-1.2mm), head / face / perioral area type (sizes 2cm×3cm, 3cm×4cm or 2cm×2cm) approximately 0.2~0.3mm (can be finely adjusted to 0.5~0.8mm); immediately cover with a polyethylene anti-adhesive layer (medical protective film) after coating.

[0351] 3.2.4 Molding, Post-processing and Packaging

[0352] 3.2.4.1 Curing and Cutting: Place the backing with the coated paste in a constant temperature and humidity environment (temperature 25℃±2℃, relative humidity 40%~50%) and let it stand to cure for 30~60 minutes to make the paste stable; then cut it according to the preset specifications with a slicing machine, and remove products with uneven coating, air bubbles, or damage to obtain the formed external acupoint water-based gel patch.

[0353] 3.2.4.2 Packaging: The molded products shall be classified according to their type and individually packaged in aluminum foil bags or sealed bags.

[0354] 3.3. Key Process Control Points

[0355] 3.3.1 Carbomer swelling: It must be completely swollen without any particle residue, otherwise it will affect the uniformity and viscosity of the paste, and thus affect the application effect.

[0356] 3.3.2 pH adjustment: Triethanolamine should be added slowly and stirred quickly to prevent localized excessive alkalinity from causing gel demulsification or thinning, and to ensure matrix stability.

[0357] 3.3.3 Mixing and homogenization: Ensure that the dry powder, borneol / menthol and other high-density powders are completely dispersed to avoid sedimentation, ensure that the content of effective ingredients in each patch is uniform, and avoid uneven local efficacy.

[0358] 3.3.4 Vacuum degassing: Thorough degassing is the key to ensuring a smooth plaster surface, comfortable application, and uniform efficacy. It is necessary to strictly control the vacuum level and degassing time.

[0359] 3.3.5 Environmental control: Temperature and humidity must be controlled in the preparation, coating and slicing areas (20-25℃ recommended, RH < 50%) to prevent the ointment from absorbing water or drying out; the entire process must be carried out in a clean environment, and the cleanliness of the environment must meet pharmaceutical standards to avoid the contamination of impurities and microorganisms.

[0360] 3.3.6 Temperature control: The temperature must be strictly controlled during the extraction, matrix melting, concentration and drying processes to avoid excessive temperature that could lead to loss of active ingredients; the paste should be allowed to cool naturally after application to avoid high temperature affecting the paste's viscosity and efficacy.

[0361] 3.4 Characteristics and advantages of the preparation method

[0362] 3.4.1 Standardization and Flexibility: The universal matrix process is stable, and five different functional patches can be quickly produced by changing the "active ingredient module". The production efficiency is high, the quality is consistent, and it is suitable for large-scale production needs.

[0363] 3.4.2 Excellent performance: The resulting patch has a large drug loading capacity, good transdermal permeability, strong moisturizing properties, good skin compatibility, no pulling pain, and no adhesive residue after peeling, thus improving the comfort of application.

[0364] 3.4.3 High adaptability: By adjusting the coating thickness, backing material and application specifications, it can be flexibly adapted to the application needs of different parts of the body (such as face, limbs, back and abdomen), especially suitable for the delicate skin around the mouth.

[0365] 3.4.4 Syndrome Differentiation and Adaptation: Taking into account the TCM syndrome differentiation and treatment concept, the 5 types of special active ingredients accurately correspond to different oral discomfort syndromes. Combined with the acupoint targeting characteristics, it ensures that the efficacy of the patch is accurately exerted and adapts to the needs of external conditioning.

[0366] This general preparation method provides a reliable and efficient technical path for the large-scale and standardized production of five types of special external acupoint water-based gel poultices, taking into account operability, stability and practicality.

[0367] Equivalent replacement scheme for medicinal materials

[0368] 1. Equivalent replacement of oral protection chewable tablets with medicinal materials

[0369] Each ingredient in the oral protection chewable tablet can be replaced in equal amounts, and the function and effect remain basically the same after replacement.

[0370] Honeysuckle extract can be replaced with any one of dandelion extract, forsythia extract, or chrysanthemum extract.

[0371] Magnolia officinalis extract can be replaced with either gallnut extract or tea polyphenols.

[0372] Clove extract can be replaced with cinnamon extract;

[0373] Licorice extract can be replaced with any one of the following: jujube extract, yam extract, or poria extract;

[0374] Peppermint extract can be replaced with either spearmint extract or menthol.

[0375] Xylitol can be replaced with any one of erythritol, maltitol, or sorbitol.

[0376] 2. Equivalent replacement of oral protective toothpaste ingredients

[0377] Each ingredient in the oral protective toothpaste can be replaced in equal amounts, and the function and effect remain essentially the same after replacement.

[0378] Honeysuckle extract can be replaced with either dandelion extract or forsythia extract.

[0379] Magnolia officinalis extract can be replaced with either gallnut extract or tea polyphenols.

[0380] Clove extract can be replaced with cinnamon extract;

[0381] Licorice extract can be replaced with either jujube extract or yam extract.

[0382] Peppermint extract can be replaced with either spearmint extract or menthol.

[0383] 3. Equivalent replacement of topical hydrophilic gel poultices with medicinal materials

[0384] Each ingredient in the topical hydrophilic gel patch can be replaced in equal amounts, and the function and effect remain essentially the same after replacement.

[0385] Honeysuckle extract can be replaced with any one of dandelion extract, forsythia extract, or chrysanthemum extract.

[0386] Magnolia officinalis extract can be replaced with either gallnut extract or tea polyphenols.

[0387] Clove extract can be replaced with cinnamon extract;

[0388] Licorice extract can be replaced with any one of the following: jujube extract, yam extract, or poria extract;

[0389] Peppermint extract can be replaced with either spearmint extract or menthol.

[0390] Equivalent dosage form replacement scheme

[0391] 1. The oral protection chewable tablets may also be formulated as any one of the following: lozenges, orally disintegrating tablets, chewing gum, soft candy, granules, powders, capsules, or oral liquids, depending on actual needs;

[0392] 2. The oral protective toothpaste can also be formulated as any one of the following, depending on actual needs: toothpaste, tooth mousse, tooth powder, oral care gel, mouthwash, or oral spray;

[0393] 3. The aforementioned hydrophilic gel poultice can also be formulated as any one of the following: water-based gel patch, poultice, gel, film, ointment, cream, lotion, liniment, or spray, depending on actual needs.

[0394] The above equivalent replacement schemes are all selected based on the principles of consistent efficacy, similar effects, and conventional substitution within the field, and do not exceed the reasonable understanding and conventional selection range of those skilled in the art.

[0395] Oral protective compositions prepared by the above method

[0396] A. Usage and dosage of oral protective chewable tablets

[0397] 1. Daily prevention and basic protection: It is recommended to chew one tablet every morning or after meals to form a protective film on the oral mucosa, inhibit the colonization of pathogenic bacteria, reduce plaque formation, and freshen breath.

[0398] 2. Emergency relief for oral discomfort: When experiencing swollen and painful gums, bad breath, or burning sensation in the mucous membranes, immediately chew 1-2 tablets for quick relief. Depending on the severity of symptoms, repeat every 2-3 hours, but do not exceed 4 tablets within 24 hours.

[0399] 3. Long-term oral care: Chew one tablet daily for continuous antibacterial protection of gums, repair of mucosa, regulation of oral microecology, and reduction of the risk of tooth decay, periodontal discomfort, and recurrent oral ulcers.

[0400] Directions for use: Take out the chewable tablet, put it in your mouth and chew it thoroughly until it completely disintegrates and the active ingredients are fully released (about 3 to 5 minutes). You can swallow it without water.

[0401] B. Usage and dosage of oral protective toothpaste

[0402] 1. Daily cleaning and protection: Brush your teeth once in the morning and once in the evening, using about 1g each time (about the size of a soybean to a pea). Brush for at least 2 minutes, and rinse your mouth and spit it out after cleaning.

[0403] 2. Enhanced antibacterial and gum protection: Brush once more after lunch, especially suitable for people with oral irritation and bleeding gums.

[0404] 3. Sensitive and soothing care: When experiencing dry mouth or sensitive gums, apply a thin layer of toothpaste to the affected area, gently massage for 1 minute, and then rinse your mouth. Repeat 1-2 times daily.

[0405] How to use: Use as usual when brushing your teeth to clean all surfaces of the mouth, paying special attention to cleaning the gum line and interdental areas; do not swallow.

[0406] C. Usage and dosage of topical acupoint water-based gel poultices

[0407] 1. Select the appropriate patch based on your main symptoms: For red and swollen gums and bad breath, choose the heat-clearing and fire-purging type; for mild gum pain and dry mouth, choose the yin-nourishing and dryness-moistening type; for recurrent oral discomfort, choose the spleen-strengthening and qi-tonifying type; for external wind-heat, red and swollen gums accompanied by throat discomfort, choose the heat-clearing and exterior-releasing type; for sticky mouth, slightly swollen gums, and epigastric fullness, choose the warming and cold-dispersing type.

[0408] 2. Dosage and timing:

[0409] Daily health care: Select 2-3 main acupoints for application each time, and each patch lasts for 6-8 hours.

[0410] For acute discomfort (swollen and painful gums, severe halitosis): Apply to 4-6 acupoints at the same time, each patch lasts for 4-6 hours, and remove after the symptoms are relieved.

[0411] 3. Frequency of use

[0412] ① Daily care: Use 2-3 times per week.

[0413] ② Treatment during peak oral health periods: Use once within 24 hours during periods of staying up late, eating spicy food, or when oral inflammation is common.

[0414] 4. Treatment course: One treatment cycle consists of continuous use for 14 to 28 days. After the cycle, intermittent use may be necessary depending on the situation.

[0415] D. Recommendations for synergistic use of the three components

[0416] To achieve the best results in "internal regulation and external protection, addressing both symptoms and root causes, and providing comprehensive protection," the following combined use plan is recommended:

[0417] 1. Comprehensive daily protection plan

[0418] In the morning: Brush your teeth thoroughly with oral protection toothpaste; After meals: Chew one oral protection chewable tablet;

[0419] Before bed: Apply water-based gel patches to the corresponding acupoints (such as Jiache and Zusanli) according to your body type to provide continuous protection throughout the day.

[0420] 2. Emergency plan for oral discomfort

[0421] When experiencing swollen and painful gums, bad breath, dry mouth, or discomfort: Immediately: Chew 1-2 oral protection chewable tablets; At the same time: Brush your teeth with oral protection toothpaste to clean your mouth; and apply the corresponding acupoints according to the syndrome type: For obvious redness, swelling, heat, and pain: apply to Jiache and Neiting; For recurring dry mouth and dull pain: apply to Taixi and Sanyinjiao; For weakness and easy recurrence: apply to Zusanli and Pishu.

[0422] 3. Long-term care plan (for people with sensitive mouths, prone to inflammation, or experiencing recurring discomfort)

[0423] Daily: Brush your teeth with oral-specific protective toothpaste morning and night;

[0424] Daily or every other day: Chew one oral protection chewable tablet after meals;

[0425] Apply the patch 2-3 times per week to the relevant acupoints, selecting the appropriate type based on your constitution. Use once daily for 6-8 hours each time. A treatment cycle consists of 14-28 days of continuous use. After each cycle, rest for 1-2 days before continuing.

[0426] The multifunctional oral health protection composition prepared by the above method has the following functions: cleaning the oral cavity, inhibiting bacteria, preventing tooth decay, protecting gums, freshening breath, repairing oral mucosa, relieving gum discomfort, and regulating oral microecology. Detailed Implementation

[0427] The present invention will be further described in detail below with reference to specific embodiments. It should be understood that the specific embodiments described herein are only for explaining the present invention and are not intended to limit the scope of protection of the present invention. Various non-substantial modifications, substitutions, and variations made by those skilled in the art to the embodiments after reading this specification, without departing from the technical principles of the present invention, should be covered within the scope of protection of the present invention. The raw materials used in the present invention are all commercially available food-grade or pharmaceutical-grade raw materials, and operations not specifically described employ conventional processes.

[0428] Example 1: Adult Oral Protective Chewable Tablets

[0429] 1.1 Raw material composition (parts by weight)

[0430] Honeysuckle extract 8 parts, Magnolia officinalis extract 3 parts, clove extract 1.5 parts, licorice extract 2.5 parts, peppermint extract 3.5 parts, xylitol 25 parts, monk fruit extract 5.5 parts, maltodextrin 20 parts, microcrystalline cellulose 12.5 parts, magnesium stearate 1.5 parts.

[0431] 1.2 Preparation method

[0432] Each extract was pulverized and passed through a 100-mesh sieve, and magnesium stearate was passed through an 80-mesh sieve. The extract was mixed with xylitol, maltodextrin, and microcrystalline cellulose according to the formula for 25 minutes, and then magnesium stearate was added and mixed for another 10 minutes. The tablets were compressed using a rotary tablet press at a pressure of 6-8 kN, with a tablet weight of 0.8 g and a hardness of 4-6 kgf. The tablets were then sterilized under ultraviolet light for 30 minutes and packaged in aluminum-plastic packaging.

[0433] 1.3 Applications

[0434] For adults, this product is used to inhibit oral bacteria, prevent tooth decay, protect gums, and freshen breath. Take one tablet 3-4 times daily, chewing and dissolving it in the mouth each time.

[0435] Example 2: Oral protection chewable tablets for young children

[0436] 2.1 Raw material composition (parts by weight)

[0437] Honeysuckle extract 6 parts, Magnolia officinalis extract 2.5 parts, clove extract 1.1 parts, licorice extract 3.5 parts, peppermint extract 2.2 parts, xylitol 28 parts, monk fruit extract 6.5 parts, maltodextrin 22 parts, microcrystalline cellulose 11 parts, magnesium stearate 1.1 parts.

[0438] 2.2 Preparation method

[0439] The raw materials are ultra-finely pulverized through a 120-mesh sieve, dry-granulated, with a particle size of 0.2–0.5 mm; tableting pressure is 4–5 kN, tablet weight is 0.6 g, and hardness is 2–3 kgf; the tablets are dried at low temperature to a moisture content of ≤3% and then aseptically packaged.

[0440] 2.3 Applications

[0441] Suitable for children aged 2-6 years to prevent tooth decay and gently protect gums. Take 1 tablet 2-3 times daily.

[0442] Example 3: Oral Protective Toothpaste for the General Population

[0443] 3.1 Raw material composition (100g)

[0444] Purified water 40g, glycerol 18g, sodium carboxymethyl cellulose 1.2g, hydrated silica 22g, xylitol 3.5g, sodium lauroyl sarcosinate 2.2g, disodium edetate 0.03g, vitamin E 0.08g;

[0445] Active ingredients: Honeysuckle extract 0.4g, Licorice extract 0.3g, Peppermint extract 0.25g, Phyllanthus emblica extract 0.4g, Cranberry extract 0.4g, Magnolia officinalis extract 0.2g, Dandelion extract 0.3g, Menthol 0.08g.

[0446] 3.2 Preparation method

[0447] The medicinal materials were dried and pulverized at ≤60℃, extracted with water at 45℃ for 1.5h twice, concentrated and spray-dried to obtain the extract; the aqueous phase and powder phase were prepared and mixed separately, emulsified and homogenized, vacuum degassed, menthol was added for flavoring, aged at 25℃ for 36h, and then filled and sealed.

[0448] 3.3 Applications

[0449] For daily oral hygiene, antibacterial and anti-plaque care, brush your teeth twice a day.

[0450] Example 4: Protective toothpaste for the elderly

[0451] 4.1 Raw material composition (100g)

[0452] Purified water 38g, glycerin 20g, sodium carboxymethyl cellulose 1.3g, low-hardness hydrated silica 20g, xylitol 2.5g, sodium lauroyl sarcosinate 1.8g, disodium edetate 0.03g, vitamin E 0.08g;

[0453] Active ingredients: Honeysuckle extract 0.25g, Licorice extract 0.5g, Peppermint extract 0.2g, Phyllanthus emblica extract 0.3g, Cranberry extract 0.3g, Polygonatum odoratum extract 0.35g, Loquat extract 0.9g, Siraitia grosvenorii extract 0.12g, Perilla frutescens leaf extract 0.25g, Menthol 0.04g.

[0454] 4.2 Preparation method

[0455] Similar to Example 3, the stirring speed was reduced and a low-hardness abrasive was used to obtain a low-foaming and low-temperature paste.

[0456] 4.3 Applications

[0457] Suitable for elderly people with dry mouth, sensitive gums, and root caries prevention; brush teeth twice daily.

[0458] Example 5: Hydrophilic Gel Patch for Stomach Fire Inflammation

[0459] 5.1 Raw material composition (100g)

[0460] Active dry powder: honeysuckle 4g, dandelion 3g, peony bark 1.5g, red peony root 1.5g, licorice root 0.8g, menthol 0.5g;

[0461] Matrix: Carbomer 940 6.5g, hydroxypropyl cellulose 1.2g, glycerin 18g, propylene glycol 10g, polyethylene glycol 400 3g, azone 1.2g, kaolin 4g, lanolin 2.5g, ethylparaben 0.2g, triethanolamine to adjust pH to 6.0-6.5, purified water added to 100g.

[0462] 5.2 Preparation method

[0463] The medicinal materials were refluxed and extracted twice, concentrated and spray-dried to obtain a dry extract powder; after swelling with carbomer, it was mixed with the matrix components, and the dry extract powder and azone were added, and the mixture was homogenized and degassed; it was coated on non-woven fabric with a thickness of 0.3 μm, cured and cut into 3 cm × 3 cm pieces, and packaged in aluminum foil.

[0464] 5.3 Applications

[0465] For swollen and painful gums and bad breath caused by excessive stomach fire, apply to the acupoints of Jiache, Dicang, Neiting, and Weishu, 1-2 times a day, 4-6 hours each time.

[0466] Example 6: Hydrophilic Gel Patch for Yin Deficiency and Hyperactivity of Fire

[0467] 6.1 Raw material composition (100g)

[0468] Active dry powder: Polygonatum odoratum 3g, loquat extract 2g, mulberry extract 1.5g, Ophiopogon japonicus 1.5g, lily bulb 1.5g, licorice 0.8g;

[0469] Matrix: Carbomer 940 6g, hydroxypropyl cellulose 1g, glycerin 22g, propylene glycol 9g, polyethylene glycol 400 2.5g, azone 1.0g, kaolin 3.5g, lanolin 3g, ethylparaben 0.18g, triethanolamine to adjust pH to 6.5-7.0, purified water added to 100g.

[0470] 6.2 Preparation method

[0471] The 2.5cm × 2.5cm patch was prepared by low-temperature water extraction, concentration and drying to form powder, following the process in Example 5.

[0472] 6.3 Applications

[0473] For mild gum pain and dry mouth caused by yin deficiency and excessive fire, apply to the following acupoints: Quanliao, Jiache, Taixi, and Sanyinjiao, once a day for 6-8 hours each time.

[0474] Example 7: Hydrophilic Gel Patches for Spleen and Stomach Deficiency

[0475] 7.1 Raw material composition (100g)

[0476] Active dry powder: licorice 2.5g, dried tangerine peel 1.5g, amla extract 1.5g, yam 1.5g, poria cocos 1.5g, jujube 0.6g;

[0477] Matrix: Carbomer 940 6g, hydroxypropyl cellulose 1.5g, glycerin 23g, propylene glycol 9g, polyethylene glycol 400 2.5g, azone 0.9g, kaolin 3.5g, lanolin 2.5g, ethylparaben 0.15g, triethanolamine to adjust pH to 6.5-7.0, purified water added to 100g.

[0478] 7.2 Preparation method

[0479] Same as in Example 5, gently extract with water to make a 4cm×4cm patch.

[0480] 7.3 Applications

[0481] For recurrent oral discomfort and mild gum pain caused by spleen and stomach deficiency, apply to Zusanli, Pishu, Zhongwan, and Jiache acupoints once a day.

[0482] Comparative Examples

[0483] Comparative Example 1: Commercially available ordinary breath freshener chewable tablets do not contain the functional extracts of this invention.

[0484] Comparative Example 2: Commercially available conventional fluoride toothpaste, which does not contain the plant extract of this invention.

[0485] Effect test case

[0486] Test Example 1: In vitro antibacterial test

[0487] In vitro antibacterial tests were conducted using the agar perforation method. Streptococcus mutans, Pyrhodomonas gingivalis, and Escherichia coli were used as test species. The diameter of the inhibition zone was measured in mm. Three replicates were set up for each group. Results are expressed as mean ± standard deviation. Statistical analysis of the experimental data was performed using the t-test. P < 0.05 was considered statistically significant. The results are as follows:

[0488] sample Streptococcus mutans (mm) Porphyromonas gingivalis (mm) Escherichia coli (mm) Example 1 15.2±0.3 14.8±0.2 13.5±0.3 Example 3 14.6±0.2 14.3±0.3 12.9±0.2 Comparative Example 1 7.3±0.4 6.8±0.3 7.1±0.3 Comparative Example 2 8.1±0.3 7.5±0.2 7.4±0.3

[0489] The results showed that, compared with the comparative examples, the product of the present invention exhibited a significantly larger inhibition zone diameter against the aforementioned common oral pathogens, with a statistically significant difference (P<0.05), indicating that the antibacterial effect of the product of the present invention was significantly better than that of the control.

[0490] Test Example 2 Safety Test

[0491] 120 volunteers were selected and divided into the following groups: 30 adults, 30 children, 30 elderly, and 30 sensitive individuals. They used the product of this invention continuously for 90 days, and the occurrence of adverse reactions such as mucosal irritation, gastrointestinal discomfort, and skin allergies was observed and recorded.

[0492] The results showed that no adverse reactions occurred in any of the volunteer groups, indicating that the product of this invention has good safety.

[0493] Experiment Example 3 Stability Test

[0494] The product of this invention was subjected to an accelerated test for 6 months at a temperature of 40℃±2℃ and a relative humidity of 75%±5%. Samples were taken at 0, 1, 2, 3 and 6 months of the test to test indicators such as appearance, sensory properties, content of active ingredients, microbial limit, pH value, formability and stability of the paste.

[0495] The results showed that the chewable tablets did not absorb moisture, crack, or change color; the toothpaste did not separate, mold, or leak water; and the poultice patch did not leak oil, migrate, or peel off. All test indicators met the product quality standards, indicating that the product of this invention has excellent stability.

[0496] Finally, it should be noted that the specific embodiments described above enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the present invention in any way. Therefore, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the present invention; and all technical solutions and improvements that do not depart from the spirit and technical essence of the present invention should be covered within the protection scope of this patent.

Claims

1. A multifunctional oral health protection composition, characterized in that, It consists of three parts: oral protective chewable tablets, oral protective toothpaste, and topical hydrophilic gel patch for acupoints. The three parts are formulated with the same source, complement each other in efficacy, and work synergistically to build a full-chain oral protection system of "cleaning - antibacterial - gum protection - repair - soothing - conditioning". The oral protection chewable tablets are for oral administration, achieving long-lasting antibacterial effect, preventing tooth decay and protecting gums, and maintaining the oral microecology. The oral protective toothpaste is used for external brushing and achieves deep cleaning, immediate antibacterial effect, and enamel and film protection. The topical hydrophilic gel patch is applied to acupoints to dredge meridians, target and soothe, and relieve redness, swelling, and pain.

2. The composition according to claim 1, characterized in that, The oral protection chewable tablets, by weight, contain the following ingredients: 5-10 parts honeysuckle extract, 2-4 parts magnolia bark extract, 1-2 parts clove extract, 2-4 parts licorice extract, 2-4 parts peppermint extract, 20-30 parts xylitol, 4-7 parts monk fruit extract, 15-25 parts maltodextrin, 10-15 parts microcrystalline cellulose, and 1-2 parts magnesium stearate. The chewable tablets are formulated with different proportions for children aged 2-6, 6-12, 13-18, 18-59, over 60, and sensitive groups.

3. The composition according to claim 2, characterized in that, The oral protection chewable tablets are formulated with a combination of principal, assistant, adjuvant, and guiding ingredients: the principal ingredient is honeysuckle extract, which has the core function of inhibiting bacteria and protecting gums; the assistant ingredients are magnolia bark extract and clove extract, which work synergistically to prevent tooth decay and regulate the flora; the adjuvant ingredients are licorice extract and peppermint extract, which protect the mucosa, harmonize the medicinal properties, and improve the taste; and the guiding ingredients are xylitol, monk fruit extract, maltodextrin, microcrystalline cellulose, and magnesium stearate, which are used for flavoring, shaping, and guiding the release of medicinal effects.

4. The composition according to claim 1, characterized in that, The oral protective toothpaste uses food-grade hydrated silica, glycerin, sodium carboxymethyl cellulose, and purified water as a general base, and adds honeysuckle extract, amla extract, cranberry extract, licorice extract, Solomon's seal extract, and loquat extract as core active ingredients. It does not contain SLS foaming agent, artificial coloring, or synthetic preservatives. The toothpaste is available in four different formulas: children's, women's, elderly, and general population.

5. The composition according to claim 4, characterized in that, The oral protective toothpaste contains: honeysuckle extract at 0.1%–0.5%; amla extract and cranberry extract at 0.1%–0.5%; licorice extract at 0.2%–0.6%; xylitol at 2.0%–5.0%; and menthol at 0.3%–1.0%.

6. The composition according to claim 1, characterized in that, The external acupoint hydrophilic gel patch is divided into five syndrome types: heat-clearing and fire-purging type, yin-nourishing and dryness-moistening type, spleen-strengthening and qi-tonifying type, heat-clearing and exterior-releasing type, and warming the middle and dispelling cold type, which correspond to five oral discomfort syndrome types: stomach fire excess, yin deficiency and fire excess, spleen and stomach weakness, wind-heat invasion, and cold-dampness trapping the spleen. The patch uses a hydrophilic gel matrix and can be applied to any combination of acupoints, including Jiache, Dicang, Neiting, Taixi, Zusanli, Pishu, and Weishu.

7. The composition according to claim 6, characterized in that, The hydrophilic gel patch matrix for external acupoint application comprises, per 100g: 6.0–7.0g of carbomer 940, 1.0–2.0g of hydroxypropyl cellulose, 18.0–25.0g of glycerin, 8.0–12.0g of propylene glycol, 2.0–4.0g of polyethylene glycol 400, 0.5–1.5g of azone, triethanolamine to adjust pH to 6.0–7.0, 0.05–0.09g of benzalkonium bromide, and purified water to 100g.

8. A method for preparing the multifunctional oral health protection composition according to any one of claims 1 to 7, characterized in that, Includes the following steps: (1) Oral protection chewable tablets: raw materials are dried at low temperature, pulverized, extracted at low temperature, concentrated and dried, mixed and granulated, granulated at low temperature, compressed into tablets, sterilized and packaged. (2) Oral protective toothpaste: raw material pretreatment, low temperature extraction, powdering, aqueous phase preparation, powder phase preparation, emulsification and homogenization, vacuum degassing, flavoring, curing, filling and sealing; (3) External application of hydrophilic gel patch for acupoints: medicinal material extraction and drying, gel matrix swelling and neutralization, paste mixing, homogenization and degassing, coating, curing and cutting, and individual packaging.

9. The preparation method according to claim 8, characterized in that: The extraction and drying temperatures of the chewable tablets, toothpaste, and poultices are all no higher than 60°C to maximize the retention of active ingredients. The patch is produced in a modular manner, and the standardized preparation of five types of patches can be achieved by changing the active dry powder module.

10. The composition according to any one of claims 1 to 7, characterized in that, The method of using the composition in combination is as follows: brush your teeth with oral protective toothpaste in the morning, chew oral protective chewing tablets after meals, and apply hydrophilic gel poultice to acupoints before going to bed according to the syndrome type. Used for daily protection, emergency relief of oral discomfort, and maintenance for people with long-term oral sensitivity and those prone to getting inflamed.