Traditional Chinese medicine composition and its use in the preparation of oral care products

Abstract

The present application belongs to the technical field of medicine, and particularly relates to a traditional Chinese medicine composition and application thereof in preparation of an oral care product. The traditional Chinese medicine composition is prepared from 12-18 parts of Qingdai, 7-12 parts of raw gypsum, 7-12 parts of Huangqi, 9-15 parts of Gushugu, 3-7 parts of Honghuajiao, 3-7 parts of Baizhi, 6-10 parts of Fangfeng, 1-5 parts of Bajie, 6-10 parts of Huanylencao, 1-5 parts of Wuji, and 4-8 parts of Baiji as raw medicinal materials. The components of the composition are reasonably matched, and can realize multiple effects of analgesia, antibiosis, anti-inflammation, repair, and tooth fixation and health. The present application is suitable for all kinds of toothache patients, has a wide application range, a safe use mode, and a wide market application prospect.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to traditional Chinese medicine compositions and their application in the preparation of oral care products. Background Technology

[0002] Toothache is one of the most common symptoms in dental clinics, often caused by diseases such as dental caries, gingivitis, periodontitis, and pulpitis. It can also be caused by traditional Chinese medicine syndromes such as wind-heat, upward flaring of fire in the lungs, stomach, and triple burner, and kidney deficiency with excessive fire. Toothache not only affects patients' eating, sleeping, and daily work, but in severe cases, it can also lead to complications such as facial infections. In recent years, with the rising incidence of malignant tumors and the widespread use of anti-tumor treatments such as radiotherapy, chemotherapy, and targeted therapy, the clinical need for treatment-related oral complications has become increasingly prominent. Patients undergoing radiotherapy for head and neck cancer often experience radiation-induced damage to the salivary glands and oral mucosa, leading to intractable complications such as radiation-induced oral mucositis, xerostomia, and radiation-induced dental caries. Chemotherapy and targeted drugs can cause oral mucositis and bone marrow suppression-related gingival bleeding, seriously affecting patients' nutritional intake, quality of life, and the smooth progress of anti-tumor treatment.

[0003] With the improvement of people's living standards and increasing attention to oral health, safe, effective, and multi-functional toothache treatments have broad market prospects. Currently, most drugs used clinically to treat toothache are chemically synthesized, such as ibuprofen, acetaminophen, and metronidazole. These drugs mainly relieve toothache symptoms through anti-inflammatory, analgesic, or antibacterial effects. However, long-term use may cause side effects such as gastrointestinal irritation, liver and kidney damage, and drug resistance. Furthermore, their mechanisms of action are singular, only providing temporary pain relief and failing to repair damaged periodontal tissues or strengthen teeth. For cancer patients, these chemical drugs often fail to address their specific pathological conditions (such as qi and yin deficiency, heat toxicity, spleen failing to control blood, and yin deficiency with fire excess) and the multiple pathogenesis of oral complications caused by radiotherapy, chemotherapy, and targeted therapy, resulting in limited clinical efficacy.

[0004] Traditional Chinese medicine has accumulated rich experience in treating toothache, recording various formulas with effects such as clearing heat and purging fire, detoxifying and reducing swelling, and relieving pain. However, existing Chinese herbal formulas mostly focus on relieving pain or reducing inflammation in acute toothaches, and are not very targeted at chronic toothaches or loose teeth caused by kidney deficiency. There is a lack of comprehensive treatment plans that can quickly relieve various toothache symptoms and can be used long-term to strengthen and maintain teeth. In particular, for complications such as oral mucositis, gingival bleeding, dry mouth and dental caries caused by radiotherapy, chemotherapy and targeted therapy in cancer patients, most existing Chinese herbal formulas lack targeted formulation design and fail to fully take into account the treatment principle of "strengthening the body's resistance and eliminating pathogenic factors" and the special syndrome characteristics of cancer patients such as deficiency of both qi and yin and internal accumulation of heat and toxins.

[0005] In summary, existing toothache treatments generally suffer from significant side effects and limited efficacy, failing to meet patients' comprehensive needs for multiple benefits such as analgesia, antibacterial properties, anti-inflammation, repair, and tooth strengthening. Furthermore, they lack effective interventions for oral complications caused by tumor radiotherapy, chemotherapy, and targeted therapy. Therefore, developing a multi-functional drug that addresses both common toothaches and oral ulcers, while also considering the specific physical conditions of cancer patients and oral complications resulting from radiotherapy, chemotherapy, and targeted therapy, has significant clinical importance and broad application prospects. Summary of the Invention

[0006] In view of this, the technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating toothache, its preparation method and application.

[0007] The traditional Chinese medicine composition provided by this invention comprises the following raw materials: coarse salt, gypsum, astragalus, drynaria, red Sichuan pepper, angelica, saposhnikovia, long pepper, eclipta, gallnut and bletilla.

[0008] The red Sichuan pepper used in this invention is red Sichuan pepper with the seeds removed. The term "removing the seeds" refers to removing the seeds (pellets or kernels) while retaining the pericarp.

[0009] This composition is scientifically and rationally formulated. Compared to other combinations, through the synergistic effects of various active ingredients such as coarse salt, gypsum, astragalus, drynaria, red Sichuan pepper (seeds removed), angelica, saposhnikovia, long pepper, eclipta, gallnut, and bletilla, it achieves multiple effects including analgesia, antibacterial, anti-inflammatory, repair, and strengthening of teeth. For example: Compared to using Psoralea corylifolia, Drynaria fortunei nourishes the kidneys, invigorates blood circulation, promotes bone and tendon healing, and strengthens teeth. In the prescription, Drynaria fortunei is used as an assistant herb, and when combined with other herbs, it is more effective in promoting periodontal ligament repair and improving alveolar bone resorption.

[0010] Compared to using Asarum, Piper longum is chosen as an adjuvant. It warms the middle burner, relieves pain, inhibits bacteria and reduces inflammation, and has good effects on toothache, swollen gums, and dentin hypersensitivity. Moreover, Piper longum has a relatively mild medicinal property and does not have the nephrotoxicity risk of aristolochic acid contained in Asarum, making it safer and more suitable for cancer patients and people who need long-term external use or mouthwash. It is beneficial for targeted and long-lasting analgesia and local inflammation control.

[0011] Compared to using large doses of bitter and cold purgatives, this formula uses raw gypsum as the principal ingredient and appropriately reduces its dosage. This can clear away accumulated heat in the stomach and intestines, thereby alleviating toothache and oral inflammation caused by excessive heat, while avoiding the harm of excessive use of bitter and cold herbs to the spleen and stomach. This expands the applicable population, and is especially suitable for long-term gargling by cancer patients with weak spleen and stomach.

[0012] Compared to traditional tooth powders that only focus on cleaning and pain relief without a film-forming protective mechanism, this formula uses Bletilla striata as an adjuvant. It is rich in mucilage, which can form a protective film on the surface of teeth and oral mucosa. It can stop bleeding and promote tissue regeneration, reduce the irritation of food and drugs on the ulcer surface, and carry drugs for sustained release, thus enhancing the long-lasting effect of the formula in stabilizing and protecting gums. It is especially suitable for cancer patients whose oral mucosal barrier is damaged after radiotherapy and chemotherapy.

[0013] Astragalus, as the principal herb, can not only enhance immunity, replenish qi and blood, and reduce the bleeding tendency of those with low platelet count caused by radiotherapy and chemotherapy, but also promote tissue regeneration and healing of ulcers in radiation or chemotherapy-related oral mucositis.

[0014] Compared to using simple astringent hemostatic drugs, this formula uses gallnut as an adjuvant, which has multiple effects including astringency, hemostasis, antibacterial properties, and mucosal repair. When combined with astragalus and bletilla in the formula, it can quickly stop gingival bleeding and promote the repair of oral ulcers and radiation-induced mucosal damage, showing a significant synergistic therapeutic effect on gingival bleeding, enamel hypersensitivity, and chemotherapy-related stomatitis.

[0015] Salt, as the principal ingredient, has the effects of clearing heat and reducing swelling, and strengthening teeth. Eclipta prostrata, as the secondary ingredient, nourishes the liver and kidneys, cools the blood and stops bleeding. It can not only improve the body's non-specific immune function, but also has antibacterial and hemostatic effects, especially for loose teeth.

[0016] Compared to whole Sichuan peppercorns, removing the seeds allows for a more effective utilization of the medicinal properties of the peppercorn pericarp. The pericarp is pungent and warm in nature, affecting the spleen and stomach meridians. It primarily contains volatile oils and amides, possessing warming and dispersing properties, insecticidal and analgesic effects, anti-inflammatory properties, and immune-enhancing effects. In contrast, the seeds are bitter and cold in nature, excelling at promoting diuresis and reducing swelling. Their medicinal properties differ from the pericarp, and mixing them may interfere with the overall warming, analgesic, and anti-inflammatory effects of the formula. Furthermore, the seeds are hard and have a high oil content, which may affect the taste and stability during preparation. Therefore, this invention selects seed-removed Sichuan peppercorns as an adjuvant, ensuring the purity and stability of the pericarp's active ingredients while avoiding interference from the seeds' medicinal properties. This allows for better synergistic effects with other ingredients in the formula, achieving comprehensive benefits such as analgesia, anti-inflammation, repair, immune enhancement, and tooth strengthening.

[0017] As an adjuvant herb, Saposhnikovia divaricata is effective in treating wind-related pain. It can dispel wind-cold and relieve exterior symptoms, as well as dispel wind-dampness and relieve pain. It also has various pharmacological effects such as anti-inflammatory, analgesic, and anti-allergic properties. Angelica dahurica, as both an adjuvant and a guiding herb, has both antimicrobial effects and sedative and gastric acid-inhibiting pharmacological activities.

[0018] The composition described in this invention, through the rational combination of medicinal ingredients, not only achieves oral care for healthy individuals, but also provides excellent oral care for patients with tumors, especially those who have undergone radiotherapy, chemotherapy, and / or targeted drug therapy.

[0019] Specifically, the traditional Chinese medicine composition described in this invention comprises the following raw materials in parts by weight: 12-18 parts of coarse salt, 7-12 parts of gypsum, 7-12 parts of astragalus, 9-15 parts of drynaria, 3-7 parts of Sichuan pepper, 3-7 parts of angelica, 6-10 parts of saposhnikovia, 1-5 parts of long pepper, 6-10 parts of eclipta, 1-5 parts of gallnut, and 4-8 parts of bletilla.

[0020] The composition of this invention has been screened and optimized in terms of proportions. Compared to other ratios, this range can effectively relieve toothache and periodontal inflammation while inhibiting oral pathogens, promoting the repair of damaged oral tissues, and enhancing the health and stability of tooth enamel and periodontal tissues. Furthermore, compared to other compositions with oral care effects, the composition of this invention can also provide excellent care for the unique oral environment of cancer patients, especially those undergoing radiotherapy, chemotherapy, or targeted drug therapy.

[0021] In some embodiments, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 14-16 parts of coarse salt, 8-10 parts of gypsum, 8-10 parts of astragalus, 10-13 parts of drynaria, 4-6 parts of Sichuan pepper, 4-6 parts of angelica dahurica, 7-9 parts of saposhnikovia divaricata, 2-4 parts of long pepper, 7-9 parts of eclipta prostrata, 2-4 parts of gallnut, and 5-7 parts of bletilla striata.

[0022] In a specific embodiment, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts coarse salt, 9 parts gypsum, 9 parts astragalus, 12 parts drynaria, 5 parts red Sichuan pepper, 5 parts angelica, 8 parts saposhnikovia, 3 parts long pepper, 8 parts eclipta, 3 parts gallnut and 6 parts bletilla.

[0023] The traditional Chinese medicine composition provided by this invention is based on long-term clinical practice. The components are scientifically and rationally combined according to the principles of traditional Chinese medicine (TCM) formulation, where each component supports the other. Specifically: The formula uses coarse salt, gypsum, and astragalus as the principal ingredients to clear heat and purge fire, soften and strengthen teeth, clean tartar, and enhance immunity. It also uses drynaria and eclipta as assistant ingredients to tonify the kidneys, strengthen teeth, nourish yin and cool the blood, and strengthen bones and teeth. Additionally, it uses saposhnikovia, Sichuan pepper (seeds removed), long pepper, gallnut, angelica, and bletilla as adjuvant ingredients to dispel wind and relieve pain, disperse cold and open the orifices, inhibit bacteria and reduce inflammation, quickly relieve tooth sensitivity and toothache, and promote healing. Angelica also serves as the guiding ingredient, astringing and stopping bleeding, strengthening teeth and protecting gums, repairing the mucosa, harmonizing the other ingredients, and enhancing the overall stability and lasting effect of the formula.

[0024] This invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of oral care products.

[0025] In some embodiments, the oral care product functions to include at least one of the following: analgesia, antibacterial, anti-inflammatory, antisensitivity, hemostasis, repair, and assistance in improving halitosis, tartar and dental calculus, and protecting and / or strengthening teeth. In other embodiments, the oral care also includes improving or treating at least one of the following: radiation-induced oral mucositis, chemotherapy-related oral mucositis, thrombocytopenia with gingival bleeding, targeted drug-related oral ulcers, or radiation-induced xerostomia with susceptibility to dental caries.

[0026] In some embodiments, the oral care product is suitable for patients with various types of toothache, including toothache caused by wind-heat, toothache caused by fire in the lungs, stomach, and triple burner, toothache caused by caries, toothache caused by swollen gums, toothache caused by kidney deficiency, and toothache caused by loose teeth; the toothache includes two types of course: acute onset and chronic protracted toothache.

[0027] In some embodiments, the oral care product is suitable for a wide range of people, covering various age groups including teenagers, middle-aged, and the elderly. Furthermore, practical experience has shown that the product also has good applicability and safety for cancer patients.

[0028] In some embodiments, the oral care product includes the traditional Chinese medicine composition as described above, as well as pharmaceutically acceptable excipients.

[0029] In some embodiments, the excipients are selected from one or more of thickeners, surfactants, abrasives, humectants, and preservatives.

[0030] In some embodiments, the oral care product also contains other auxiliary ingredients, such as menthol, camphor, and other cooling agents, to improve the taste and enhance the cooling and comfortable feeling during use.

[0031] In some embodiments, the dosage form of the oral care product includes mouth fresheners, chewing gum, toothpaste, tooth gel, tooth powder, mouthwash, or tablets.

[0032] In some specific embodiments, the oral care product is in the form of tooth powder.

[0033] Furthermore, the present invention provides a method for preparing the oral care product as described above, comprising: mixing and pulverizing the traditional Chinese medicine composition as described above; or pulverizing and mixing the traditional Chinese medicine composition as described above.

[0034] In some embodiments, the preparation method further includes a sieving step.

[0035] Furthermore, the present invention also provides a method of oral care using oral care products, comprising administering an effective amount of the traditional Chinese medicine composition or oral care product to a subject.

[0036] In this invention, the method of application includes at least one of the following: brushing, rinsing, spraying, or applying. These methods can be used individually or in combination to meet the personalized needs of different oral health problems and usage scenarios.

[0037] The present invention has the following beneficial effects: (1) Scientific formulation, taking into account both symptoms and root causes, with clear distinction between principal, assistant, adjuvant and guide herbs, focusing on the fundamental problems of periodontium and teeth, and achieving the organic unity of clearing heat and purging fire and tonifying the kidney and strengthening teeth; (2) Optimize medicinal materials, enhance efficacy and reduce toxicity. Replace or supplement traditional medicinal materials with herbs such as Drynaria fortunei, Piper longum, Galla chinensis, Astragalus membranaceus, and Bletilla striata. The medicinal properties are milder and the safety is higher. (3) It has comprehensive effects and multiple functions, combining rapid pain relief (Gallus chinensis, Saposhnikovia divaricata, Gypsum fibrosum), strengthening teeth (Gallium coronarium, Drynaria fortunei, Eclipta prostrata), protecting gums and stopping bleeding, anti-inflammatory and antibacterial and anti-sensitivity, breaking through the limitations of traditional drugs that "relieve pain but do not strengthen teeth, reduce inflammation but do not repair". (4) It is natural and safe, widely applicable, with few side effects, and suitable for special groups such as young and middle-aged people, the elderly, and cancer patients; (5) The dosage is standardized and can be used as needed. The preparation process is simple and easy to scale up production and industrial promotion, which can fully meet the multi-dimensional and high-quality oral care needs of modern people.

[0038] This invention relates to a traditional Chinese medicine composition and its application in the preparation of oral care products. The traditional Chinese medicine composition is made from the following raw materials: 12-18 parts of cobalt salt, 7-12 parts of gypsum, 7-12 parts of astragalus, 9-15 parts of drynaria, 3-7 parts of Sichuan pepper, 3-7 parts of angelica dahurica, 6-10 parts of saposhnikovia divaricata, 1-5 parts of long pepper, 6-10 parts of eclipta prostrata, 1-5 parts of gallnut, and 4-8 parts of bletilla striata. This composition is carefully formulated, has a mild effect, and is rapidly effective. It exhibits significant advantages in antibacterial and anti-inflammatory effects, astringent and hemostatic properties, toothache relief, improvement of tooth sensitivity, strengthening of teeth, protection of gums, and promotion of mucosal repair. It has significant oral care effects on both healthy individuals and cancer patients. Its raw materials are readily available, safe to use, and widely applicable, providing a safe and effective new option for the treatment and prevention of oral problems, and possessing significant practical value and application prospects. Detailed Implementation

[0039] This invention provides a traditional Chinese medicine composition and its application in the preparation of oral care products. Those skilled in the art can refer to the content of this document and appropriately modify the process parameters to achieve the desired results. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in this invention. The methods and applications of this invention have been described through preferred embodiments. Those skilled in the art can clearly modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

[0040] Unless otherwise defined in this invention, the scientific and technical terms associated with this invention shall have the meanings understood by one of ordinary skill in the art.

[0041] The terms “comprising,” “including,” and “having” are used interchangeably to indicate the inclusiveness of a scheme, meaning that the scheme may contain elements other than those listed. It should also be understood that the use of “comprising,” “including,” and “having” herein also provides for schemes “consisting of…”.

[0042] When used herein, the term “and / or” includes the meaning of “and,” “or,” and “all or any other combination of elements linked by the term.”

[0043] The term "at least one" means one or more, and "more than one" means two or more. "At least one of the following" or similar expressions refer to any combination of these items, including any combination of single or multiple items.

[0044] It should be understood that in the various embodiments of this application, the order of the above processes does not imply the order of execution. Some or all steps may be executed in parallel or sequentially. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of this application.

[0045] The purpose of this invention is to provide a pharmaceutical composition that can both relieve toothache and strengthen teeth. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 12-18 parts of coarse salt, 7-12 parts of gypsum, 7-12 parts of astragalus, 9-15 parts of drynaria, 3-7 parts of Sichuan pepper, 3-7 parts of angelica, 6-10 parts of saposhnikovia, 1-5 parts of long pepper, 6-10 parts of eclipta, 1-5 parts of gallnut, and 4-8 parts of bletilla.

[0046] This invention primarily addresses the following problems: (1) Loose teeth and exposed tooth roots; (2) Gingival recession and gingival bleeding; (3) Dentin hypersensitivity (pain from hot, cold, sour, sweet, or sour foods); (4) Periodontitis, gingivitis; (5) It can help improve bad breath, tartar, and dental calculus; (6) Long-term dental health care, and suitable for cancer patients.

[0047] The present invention has the following beneficial effects: (1) Rapid pain relief: The synergistic effect of gallnut, saposhnikovia root, and gypsum can quickly relieve toothache; (2) Strengthening teeth: Copper salt enters the kidney meridian, while Drynaria fortunei and Eclipta prostrata nourish the kidneys and strengthen bones, thus enhancing dental health; (3) Natural and safe: Pure Chinese herbal ingredients, taken as a gargle, the medicine does not enter the body, and the side effects are minimal; (4) Use as needed: It is made into tooth powder for external use, which is convenient to carry and can be used anytime, anywhere, and as needed; (5) Wide range of applications: It has the effects of treating toothache, anti-inflammatory and antibacterial, protecting gums, and strengthening teeth. It is suitable for young, middle-aged and elderly people.

[0048] The test materials used in this invention are all common commercially available products, and can be purchased on the market. Among them: Large-grained salt is a crystallized form of halite, a chloride mineral. It is salty and cold in nature, and enters the kidney, heart, and stomach meridians. It has the effects of clearing heat and reducing swelling, and strengthening teeth.

[0049] Gypsum is the mineral gypsum, a sulfate mineral. It has a pungent and sweet taste, and is very cold in nature. It is good at clearing heat from the lungs, stomach, and triple burner, and is indeed effective in reducing inflammation and swelling of the gums.

[0050] Astragalus is a plant of the legume family, specifically Astragalus mongholicus. Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus Astragalus membranaceus (Fisch.) Bge. The dried root of the plant. It is sweet and slightly warm in nature, and enters the lung and spleen meridians. It has the effects of tonifying qi and consolidating the exterior, promoting pus drainage and detoxification, and promoting tissue regeneration and wound healing. It can enhance the body's immunity, improve local resistance in the oral cavity, and promote the repair of periodontal mucosa and damaged tissues.

[0051] Drynaria fortunei is a plant of the family Quercetiaceae. Drynaria fortunei (Kunze) J. Sm. The dried rhizome. It is bitter and warm in nature, and enters the liver and kidney meridians. It has the effects of tonifying the kidney, strengthening bones and relieving pain. It can treat toothache due to kidney deficiency and loose teeth. It has significant effects in promoting osteoblast proliferation and differentiation, resisting osteoporosis, treating inflammation, protecting dental and bone cells, and protecting the kidneys. It also has sedative and analgesic effects.

[0052] Red Sichuan pepper (seeds removed) is the Sichuan pepper plant of the Rutaceae family. Zanthoxylum bungeanum Maxim. The dried, mature pericarp after the seeds have been removed. It is pungent and warm in nature, entering the spleen and stomach meridians. It can warm the middle jiao (digestive system), dispel cold, kill parasites, and relieve pain. In addition to removing dampness, it also has multiple effects such as anti-inflammation and enhancing immunity.

[0053] Angelica dahurica is a plant belonging to the Apiaceae family. Angelica dahurica (Fisch. ex Hoffm.) Benth. etc Hook. for. Or Angelica dahurica Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. for. var. formosana (Boiss.) Shan et al The dried root of the plant. It is pungent and very warm in nature, enters the hand and foot Yangming meridians, and functions to warm the middle and dispel cold. It belongs to the commonly used aromatic analgesic drugs. It not only has antimicrobial effects, but also has sedative and gastric acid-inhibiting pharmacological effects.

[0054] Saposhnikovia divaricata is a plant belonging to the Apiaceae family. Saposhnikovia divaricata (Turkish.) Schischk.The dried root of the plant. It is pungent, sweet, and warm in nature, and enters the bladder, liver, and spleen meridians. It treats wind-related ailments and relieves pain, dispelling wind-cold and relieving exterior symptoms, as well as dispelling wind-dampness and relieving pain. It also possesses various pharmacological effects, including anti-inflammatory, analgesic, and anti-allergic properties.

[0055] Piper longum is a plant belonging to the Piperaceae family. Piper longum L. The dried, nearly mature or mature fruit spikes. It is pungent and very warm in nature, enters the hand and foot Yangming meridians, and functions to warm the middle and dispel cold. It belongs to the commonly used aromatic analgesic drugs. It not only has antimicrobial effects, but also has sedative and gastric acid-inhibiting pharmacological effects.

[0056] Eclipta prostrata is a plant belonging to the Asteraceae family. Eclipta prostrate L. The dried aerial parts of the plant. It is sweet, sour, and cold in nature. It enters both the kidney and liver meridians, nourishing the liver and kidneys, cooling the blood, and stopping bleeding. It not only enhances the body's non-specific immune function, has antibacterial and hemostatic effects, but also has a special therapeutic effect on loose teeth.

[0057] Gallnut is a plant of the Anacardiaceae family, Rhus chinensis. Rhus chinensis Mill. , green bran poplar Rhus potanini Maxim. Or red bran poplar Rhus punjabensis Stew. var. sinica (Diels) Rehd. et Wils. The galls on the leaves are mainly caused by gall aphids. Melaphis chinensis (Bell) Baker It is formed through parasitism. It is acidic, astringent, and cold in nature, and enters the lung, large intestine, and kidney meridians. It has detoxifying and swelling-reducing effects and inhibits various bacteria. Its anti-inflammatory and antibacterial components have a positive effect on alleviating gingival inflammation and promoting periodontal tissue repair.

[0058] Bletilla striata is a plant in the Orchidaceae family. Bletilla striata (Thunb.) Reichb. for. The dried tuber of the plant. It has a bitter, sweet, and astringent taste, and is slightly cold in nature. It enters the lung, liver, and stomach meridians. It has the effects of astringing and stopping bleeding, reducing swelling and promoting tissue regeneration, and protecting the mucous membrane. It can promote the healing of wounds such as gingival damage and oral mucosal ulcers, enhance the mucosal barrier, reduce gingival bleeding and sensitivity, and has good anti-inflammatory, repairing and gingival protecting effects.

[0059] The above-mentioned components are scientifically and rationally combined according to the principles of traditional Chinese medicine (TCM) formulation, with each component supporting the other. The principal ingredients are coarse salt, gypsum, and astragalus, which clear heat and purge fire, soften and strengthen teeth, clean plaque, and enhance immunity. The assistant ingredients are drynaria and eclipta, which tonify the kidneys, strengthen teeth, nourish yin and cool the blood, and strengthen bones and teeth. The adjuvant ingredients are saposhnikovia, Sichuan pepper (seeds removed), long pepper, gallnut, angelica, and bletilla, which dispel wind and relieve pain, disperse cold and open the orifices, inhibit bacteria and reduce inflammation, quickly relieve tooth sensitivity and toothache, and promote healing. Angelica also serves as the guiding ingredient, astringing and stopping bleeding, strengthening teeth and protecting gums, repairing the mucosa, harmonizing the other ingredients, and enhancing the overall stability and lasting effect of the formula. The combined use of these herbs achieves a synergistic effect across multiple targets, including clearing heat and purging fire, tonifying the kidneys and strengthening teeth, dispelling wind and relieving pain, inhibiting bacteria and inflammation, and astringing and protecting gums. This provides comprehensive and systematic intervention for various oral problems such as toothache due to wind-heat, toothache due to lung and stomach fire, toothache due to dental caries, swollen and painful gums, toothache due to kidney deficiency, loose teeth, and oral complications related to tumor treatment. It solves the problem of existing products having only single effects and treating the symptoms but not the root cause. This composition is meticulously formulated, has a gentle effect, and is fast-acting. It has outstanding advantages in relieving toothache, improving tooth sensitivity, strengthening teeth, protecting gums, and promoting mucosal repair. Its raw materials are readily available, safe to use, and widely applicable, providing a safe and effective new option for the treatment and prevention of oral problems, and has significant practical value and application prospects.

[0060] The numerical ranges and parameters involved in this invention have been presented as precisely as possible in the specific embodiments. However, any numerical value inevitably contains standard deviations due to individual test methods. Therefore, unless otherwise expressly stated, it should be understood that all numerical ranges or specific data used in this disclosure may have a reasonable deviation within a certain range, such as ±10%, ±5%, ±1%, or ±0.5%.

[0061] The present invention will be further illustrated below with reference to the embodiments: Example 1: Preparation of the composition and its application method 1. Preparation of the composition Preparation method 1: Weigh out 15g of coarse salt, 9g of gypsum, 9g of astragalus, 12g of drynaria, 5g of Sichuan pepper, 5g of angelica, 8g of saposhnikovia, 3g of long pepper, 8g of eclipta prostrata, 3g of gallnut, and 6g of bletilla striata according to the weight ratio, mix and grind them, and sieve them to obtain the final product.

[0062] Preparation method 2: Weigh out 15g of coarse salt, 9g of gypsum, 9g of astragalus, 12g of drynaria, 5g of red Sichuan pepper, 5g of angelica dahurica, 8g of saposhnikovia divaricata, 3g of long pepper, 8g of eclipta prostrata, 3g of gallnut, and 6g of bletilla striata according to the following proportions. Grind the above Chinese medicinal materials into a fine powder, mix them evenly according to the proportions, and prepare the product (two medical cotton swabs are included in the portable package).

[0063] Regardless of whether the preparation method involves mixing before pulverizing or pulverizing before mixing, the composition can be obtained without affecting the final effect of the product.

[0064] 2. Clinical efficacy observation

[0065] (1) General information: 48 outpatients who met the diagnostic criteria of "tooth ulcer" or "(tumor treatment complications) oral ulcer" in traditional Chinese medicine were selected.

[0066] (2) Diagnostic criteria: Western medicine diagnosis refers to "Oral Science"; TCM diagnosis refers to the relevant criteria for "toothache", "gutting", "loose teeth" and "aphthous ulcers" in "Guiding Principles for Clinical Research of New Chinese Medicine".

[0067] 3. Instructions for use: For external use: Use this composition to rub or brush your teeth every morning or evening, then rinse with warm water for 1-2 minutes and spit it out. The portable pack is for use whenever needed. It is not recommended to use this composition more than 3 times a day.

[0068] Using the composition prepared in Example 1, rinse your mouth 2-3 times a day after brushing your teeth (patients with more severe symptoms can rinse 4-6 times a day), for about 2 minutes each time, for 7 days as one course of treatment.

[0069] Example 2 Typical Case

[0070] Case 1: General information: Patient Li, male, 45 years old, first visit on March 10, 2024.

[0071] Chief complaint: Recurrent toothache accompanied by loose teeth for six months, worsening in the last three days.

[0072] Present illness: For the past six months, the patient has frequently experienced swollen and painful gums, which are aggravated by hot and cold stimuli. Recently, due to staying up late and overwork, the gums have become red, swollen and bleeding, and the teeth feel loose. The patient also experiences dry mouth and lower back pain.

[0073] Traditional Chinese Medicine Four Diagnostic Methods: Inspection: Red and swollen gums, bright red in color; red tongue with a thin yellow coating. Auscultation: Foul breath. Inquiry: Dry mouth with a preference for cold drinks; soreness and weakness in the lower back and knees; poor sleep; dry stools. Palpation: Thready and rapid pulse.

[0074] Traditional Chinese Medicine diagnosis: Toothache (excessive stomach fire, combined with kidney yin deficiency).

[0075] Treatment: Clear stomach heat and purge fire, supplemented with kidney-tonifying and teeth-strengthening herbs.

[0076] Prescription: Use the formula from Example 1, grind them into a fine powder, and brush your teeth with it for 2 minutes each time, morning and evening.

[0077] Quantitative indicators: Before treatment: Gingival bleeding index (BI) = 3, tooth mobility = grade I~II, pain score (VAS) = 6 points, TCM syndrome score = 18 points.

[0078] Post-treatment: BI=0, mobility=0 degrees, VAS=0 points, TCM syndrome score=4 points.

[0079] Therapeutic effect observation: Three days after treatment: the redness and swelling of the gums subsided, the pain was significantly relieved (VAS score dropped to 2), and bleeding during brushing decreased.

[0080] Seven days after treatment: Gingival bleeding disappeared (BI=0), tooth loosening decreased (looseness improved to 0 degrees), and symptoms of dry mouth and lower back pain improved. The tongue was pale red with a thin white coating, and the pulse was thready. No recurrence was observed during a one-month follow-up.

[0081] Therapeutic effect evaluation: Cured (gingival redness and swelling subsided, bleeding stopped, and tooth loosening was basically restored).

[0082] Using the composition from Example 1 for brushing teeth morning and night, significant effects were observed after 3 days of treatment: gingival redness and swelling subsided, the VAS pain score dropped sharply from 6 to 2, and bleeding during brushing decreased. After 7 days of treatment, gingival bleeding completely disappeared (BI=0), tooth mobility recovered from grade I-II to grade 0, and systemic symptoms such as dry mouth and lower back pain also improved. The tongue and pulse became normal, and the TCM syndrome score decreased from 18 to 4. No recurrence was observed during a one-month follow-up, meeting the clinical cure criteria. This case fully demonstrates that this composition has significant advantages in rapid pain relief, swelling reduction and hemostasis, tooth stabilization, and improvement of systemic symptoms, providing a safe, effective, and convenient new option for the prevention and treatment of periodontal disease.

[0083] Case 2: General information: Patient Wang, female, 60 years old, first visit on May 6, 2024.

[0084] Chief complaint: Sore and weak teeth for more than a year.

[0085] Present illness: The patient reports tooth sensitivity, difficulty chewing, discomfort in cold, hot, sour, and sweet foods, gum recession, and mild tooth loosening.

[0086] Traditional Chinese Medicine Four Diagnostic Methods: Inspection: Receding gums, slightly exposed tooth roots, pale tongue with little coating. Auscultation: No unusual odor. Inquiry: Dizziness and tinnitus, soreness and weakness in the lower back and knees, aversion to cold and cold limbs. Palpation: Deep and thready pulse.

[0087] Traditional Chinese Medicine diagnosis: bleeding gums, loose teeth (kidney yang deficiency, teeth not being properly nourished).

[0088] Treatment: Warm the kidneys and strengthen teeth, dispel wind and relieve pain.

[0089] Prescription: Use the composition prepared in Example 1 to brush your teeth twice a day for 2 minutes each time.

[0090] Quantitative indicators: Before treatment: Schiff tooth sensitivity index = 2, tooth mobility = grade I, pain score (VAS) = 5 points, TCM syndrome score = 16 points.

[0091] After treatment: Schiff=0, loosening degree=0, VAS=0 points, TCM syndrome score=3 points.

[0092] Therapeutic effect observation: After 14 days of treatment: tooth sensitivity was significantly reduced (Schiff dropped to 1), chewing was stronger than before, and the symptoms of cold intolerance improved.

[0093] After 30 days of treatment: tooth sensitivity has basically disappeared (Schiff=0), the trend of gum recession has been controlled, and tooth mobility has improved (mobility=0 degrees).

[0094] Therapeutic effect evaluation: Significant effect (tooth sensitivity disappears, chewing function is restored).

[0095] The composition prepared in Example 1, applied twice daily during brushing, showed significant improvement after 14 days of treatment: the tooth sensitivity index (Schiff) decreased from 2 to 1, the soreness was significantly reduced, chewing became more effective, and the symptoms of cold intolerance were relieved. After 30 days of treatment, tooth soreness essentially disappeared (Schiff=0), tooth mobility recovered from grade I to grade 0, the trend of gingival recession was controlled, and systemic symptoms such as dizziness, tinnitus, and lower back and knee weakness improved simultaneously. The TCM syndrome score decreased from 16 points to 3 points, reaching the standard of significant efficacy. This case fully demonstrates that this composition is not only suitable for toothache caused by excess heat, but also has a definite curative effect on toothache caused by deficiency. Through multiple mechanisms such as tonifying the kidney and strengthening teeth, warming the meridians and dispelling cold, and dispelling wind and relieving pain, it fundamentally improves problems such as toothache, looseness, and recession, restores chewing function, and is made of all-natural ingredients, making it safe for long-term use. It provides an ideal solution for dental problems caused by age-related kidney deficiency in middle-aged and elderly people.

[0096] Case 3: General information: Patient Zhao, female, 32 years old, first visit on June 15, 2024.

[0097] Chief complaint: Severe throbbing pain in the upper right teeth for 2 days.

[0098] Present illness: Two days ago, the patient ate spicy hot pot and then stayed up late in air-conditioned room. The next day, he experienced severe pain in his upper right teeth, which was intermittent and throbbing. The pain worsened with heat and was relieved by cold. His gums were red and swollen, and the pain radiated to the right side of his head and face.

[0099] Traditional Chinese Medicine Four Diagnostic Methods: Inspection: Significant redness and swelling of the right upper gum, with visible punctate erosions; red tongue with a thin yellow coating. Auscultation: A feeling of heat in the mouth. Inquiry: The patient experiences aversion to wind, dry mouth with a preference for cold drinks, no bowel movement for two days, and yellow urine. Palpation: A floating and rapid pulse.

[0100] Traditional Chinese Medicine diagnosis: Acute attack of toothache (wind-fire toothache).

[0101] Pathogenesis analysis: External wind evil and internal stomach fire, wind and fire fight each other, and inflame the gums along the meridian.

[0102] Prescription: Use the composition prepared in Example 1 to brush your teeth 3 times a day (after breakfast, dinner and before bedtime), brushing for 2 minutes each time, allowing the powder to remain on the surface for a slightly longer time.

[0103] Quantitative indicators: Before treatment: Pain score (VAS) = 8 points, gingival redness and swelling index = 2, TCM syndrome score = 14 points.

[0104] One day after medication: VAS = 3 points.

[0105] Three days after medication: VAS = 1 point, gum swelling index = 1.

[0106] Five days after medication: VAS = 0 points, gingival redness and swelling index = 0, TCM syndrome score = 2 points.

[0107] Therapeutic effect observation: One day after taking the medication: The patient reported a significant cooling sensation in the affected area after brushing their teeth, a longer interval between pain episodes, and was able to fall asleep that night.

[0108] Three days after taking the medication: the redness and swelling of the gums subsided significantly, the throbbing pain disappeared, and there was only a slight discomfort when pressing.

[0109] Five days after medication: the redness and swelling of the gums completely subsided, the erosions healed, and bowel movements became regular. The tongue and pulse returned to normal.

[0110] Therapeutic effect evaluation: Cured.

[0111] The composition prepared in Example 1 was used for brushing teeth three times daily (after breakfast, dinner, and before bed). After one day of use, the pain score (VAS) dropped sharply from 8 to 3. Patients reported a significant cooling sensation after brushing, a significantly prolonged interval between pain episodes, and were able to fall asleep peacefully that night. After three days of use, the VAS dropped to 1, gingival swelling subsided considerably, throbbing pain disappeared, and only slight discomfort remained upon pressure. After five days of use, the pain completely disappeared (VAS=0), gingival swelling completely subsided, local erosions healed, bowel movements became regular, tongue and pulse returned to normal, and the TCM syndrome score dropped from 14 to 2, meeting the criteria for cure. This case fully demonstrates that the composition is effective for acute wind-heat toothache. Through multiple mechanisms of dispelling wind and clearing heat, reducing swelling and relieving pain, it can rapidly relieve pain within one day, significantly reduce inflammation within three days, and achieve clinical cure within five days, while also improving systemic symptoms such as constipation and dry mouth.

[0112] Case 4: General information: Patient Sun, female, 48 years old, first visit on September 3, 2024.

[0113] Chief complaint: Recurrent bleeding gums accompanied by tooth sensitivity for six months.

[0114] Present Illness: For the past six months, the patient has experienced frequent, bright red, but small amounts of bleeding gums when brushing their teeth in the morning, accompanied by tooth sensitivity, which is more pronounced when chewing. They have tried various toothpastes and vitamin supplements, but with little effect. They typically experience high work stress and often stay up late.

[0115] Traditional Chinese Medicine Four Diagnostic Methods: Inspection: The gums are red and slightly swollen, with a small amount of blood at the gum line. The teeth are clean. The tongue is reddish with little coating. Auscultation: No unusual odor. Inquiry: Dry mouth and throat, hot flashes in the palms and soles, soreness and weakness in the lower back and knees, night sweats, scanty and dark menstrual flow. Palpation: The pulse is thready and rapid.

[0116] Traditional Chinese Medicine diagnosis: Gut bleeding (Yin deficiency with excessive fire syndrome).

[0117] Pathogenesis analysis: Kidney yin deficiency leads to water failing to control fire, resulting in upward flaring of deficient fire that burns the blood vessels in the gums.

[0118] Prescription: Use the composition prepared in Example 1 to brush teeth twice a day, morning and evening, and instruct the patient to gently massage the gums while brushing.

[0119] Quantitative indicators: Before treatment: Bleeding gum index (BI) = 3, pain score (VAS) = 4, TCM syndrome score = 20.

[0120] After 7 days of treatment: BI=1, VAS=2 points, TCM syndrome score=12 points.

[0121] After 14 days of treatment: BI=0, VAS=0 points, TCM syndrome score=6 points.

[0122] After 30 days of treatment: BI=0, VAS=0 points, TCM syndrome score=3 points.

[0123] Therapeutic effect observation: Seven days after treatment: bleeding during brushing teeth was significantly reduced (BI dropped to 1), with only occasional streaks of blood, and dry mouth and throat were relieved.

[0124] After 14 days of treatment: Gingival bleeding completely stopped (BI=0), and tooth sensitivity significantly improved. Symptoms of hot flashes in the palms, soles, and chest were alleviated.

[0125] 30 days after treatment: Follow-up showed no further bleeding from the gums, teeth felt firm, and chewing was effective. The tongue turned pale red with a thin white coating.

[0126] Therapeutic effect evaluation: Significantly effective.

[0127] The composition prepared in Example 1 was used twice daily, morning and evening, for brushing. Significant improvement was observed after 7 days of treatment: the gingival bleeding index (BI) decreased from 3 to 1, bleeding during brushing was significantly reduced with only occasional streaks of blood, dry mouth and throat were alleviated, and the pain score (VAS) decreased from 4 to 2. After 14 days of treatment, gingival bleeding completely stopped (BI=0), tooth sensitivity significantly improved, chewing became stronger, symptoms of five-center heat (palms, soles, and chest) were reduced, and the TCM syndrome score decreased from 20 to 6. A follow-up 30 days after treatment showed no further gingival bleeding, teeth felt firm and strong, chewing function returned to normal, the tongue turned pale red with a thin white coating, and the TCM syndrome score further decreased to 3, reaching the standard for significant effect.

[0128] This case fully demonstrates that this composition is not only effective for toothache caused by excess heat, but also for gingival bleeding due to yin deficiency and excessive fire. Through multiple mechanisms including nourishing yin and reducing fire, tonifying the kidneys and strengthening teeth, and cooling the blood and stopping bleeding, it fundamentally improves problems such as bleeding gums and sensitive teeth. Simultaneously, it regulates systemic yin deficiency symptoms such as five-center heat (palms, soles, and chest), lower back and knee weakness, dry mouth, and night sweats, restoring tooth strength and chewing function. Made with pure natural Chinese herbal ingredients, it is safe and has no side effects with long-term use, providing an ideal solution for gum problems caused by excessive fire in people with yin deficiency.

[0129] Case 5: Tooth decay (cavity) pain (mixed cold and heat type)

[0130] General information: Patient Zhou, male, 8 years old, first visit on March 22, 2025 (reported by his parents).

[0131] Chief complaint: Nighttime pain in the lower left teeth for 3 days.

[0132] Present illness: The child has a cavity in the lower left posterior tooth. For the past 3 days, the child has experienced severe nighttime pain, crying incessantly and unable to sleep. The pain is aggravated by cold, hot, or sweet foods. The child usually prefers raw or cold foods but is also prone to abdominal pain and loose stools.

[0133] Traditional Chinese Medicine Four Diagnostic Methods: Inspection: Deep, large cavity in the lower left first molar; no obvious redness or swelling around the gums; pale tongue with a white, greasy coating. Auscultation: Slight sour, rotten smell in the mouth. Inquiry: Usually cold hands and feet; average appetite; prone to diarrhea after eating cold foods. Has not eaten properly for the past 3 days due to toothache. Palpation: Deep, tight pulse.

[0134] Traditional Chinese Medicine diagnosis: dental caries (cavities), combined with deficiency and cold in the middle jiao (middle burner).

[0135] Pathogenesis analysis: Tooth decay leads to obstruction of Qi and blood in the local meridians. The child has a constitution of spleen and stomach deficiency and cold; using purely cold medicines may damage the spleen and stomach's Yang energy. This formula combines cold and warm properties, which is appropriate for the pathogenesis.

[0136] Prescription: Using the composition prepared in Example 1, apply the powder to the area around the cavity and the tooth surface with a toothbrush, then rinse the mouth for 2 minutes each time, 3 times a day. Instruct parents to keep the child's abdomen warm.

[0137] Quantitative indicators: Before treatment: Pain score (VAS) = 7 points (children's facial expression rating scale), number of nighttime crying episodes = 3-4 times / night.

[0138] On the night of medication administration: VAS = 2 points, number of crying episodes = 0.

[0139] Three days after medication: VAS = 1 point.

[0140] Seven days after medication: VAS score = 0, number of nighttime crying episodes = 0.

[0141] Therapeutic effect observation: On the night of medication administration: Parents reported that the child's pain was significantly reduced (VAS score dropped from 7 to 2), the crying stopped, and the child slept soundly.

[0142] Three days after medication: the pain disappeared during the day, and there was occasional discomfort at night (VAS=1 point), but the child stopped crying. The pain from hot and cold stimuli decreased.

[0143] Seven days after medication: The toothache had basically disappeared (VAS=0), and the child could eat normally. During this period, bowel movements were normal, and there was no abdominal pain or diarrhea, indicating that the warming properties of Sichuan pepper and long pepper in the prescription effectively counteracted the coldness of gypsum, protecting the spleen and stomach.

[0144] Efficacy evaluation: Effective. Although dental fillings are required, this formula is remarkably effective in relieving symptoms and controlling inflammation, and it has good safety for children with a cold constitution.

[0145] The composition prepared in Example 1 was used to gently brush the area around the cavity and the tooth surface three times daily. Significant improvement was observed on the very first night of treatment: the pain score (VAS, Facial Expression Scale for Children) decreased from 7 to 2, and the number of nighttime crying episodes decreased from 3-4 times per night to 0. The child slept peacefully, and parents reported a significant reduction in pain. After three days of treatment, daytime pain was almost completely eliminated, with only occasional mild discomfort at night (VAS=1), but no further crying. The pain from hot and cold stimuli was significantly reduced. After seven days of treatment, the toothache completely disappeared (VAS=0), and the child could eat normally. Bowel movements were normal during this period, with no abdominal pain or diarrhea, indicating that the combination of warming and cooling properties in the formula not only relieved the toothache but also effectively protected the Yang Qi in the middle Jiao (middle burner). This case fully demonstrates that the composition has a significant relieving effect on toothache in children with caries (mixed cold and heat type). The pain was significantly relieved on the first night of treatment, the pain from hot and cold stimuli decreased within three days, and the pain disappeared within seven days, without causing abdominal pain or diarrhea, indicating good safety for children with a cold constitution.

[0146] Case 6: General information: Patient Wu, male, 35 years old, first visit on November 10, 2024.

[0147] Chief complaint: Sensitivity and soreness in all teeth for 1 year.

[0148] Present Illness: For the past year, the patient has experienced extreme sensitivity in their teeth to cold air, cold water, and acidic fruits. They feel tooth sensitivity immediately upon inhalation, severely impacting their quality of life. They have previously used desensitizing toothpaste, but the effects were not lasting. They also frequently experience lower back pain due to prolonged desk work.

[0149] Traditional Chinese Medicine Four Diagnostic Methods: Inspection: Slight wear on the occlusal surfaces of the teeth; no obvious gum recession; pale red in color; pale and swollen tongue with teeth marks on the edges. Auscultation: No unusual odor. Inquiry: Fatigue, weakness, soreness and weakness in the lower back and knees, aversion to cold and preference for warmth; clear and copious urine. Palpation: Deep and weak pulse.

[0150] Traditional Chinese Medicine diagnosis: Toothache (Kidney deficiency and loose teeth syndrome).

[0151] Pathogenesis analysis: The kidneys govern the bones, and teeth are an extension of the bones. When kidney yang is insufficient, the teeth lose their warmth, hence the soreness, weakness, and aversion to cold.

[0152] Prescription: Use the composition prepared in Example 1, brush your teeth twice a day, morning and evening, and rinse for 1-2 minutes each time before spitting it out to allow the medicine to penetrate.

[0153] Quantitative indicators: Before treatment: Schiff tooth sensitivity index = 3, VAS pain score = 6, TCM syndrome score = 18.

[0154] Seven days after treatment: Schiff=2, VAS=3.

[0155] 14 days after treatment: Schiff=1, VAS=1 point.

[0156] After 30 days of treatment: Schiff=0, VAS=0 points, TCM syndrome score=4 points.

[0157] Therapeutic effect observation: Seven days after treatment: The patient reported a decrease in sensitivity to cold water stimulation (Schiff decreased from 3 to 2), and a reduction in soreness during inhalation.

[0158] 14 days after treatment: Can rinse mouth with cold water normally (Schiff=1), no discomfort when eating sweet and sour fruits (VAS=1).

[0159] After 30 days of treatment: Tooth sensitivity has basically disappeared (Schiff=0), and chewing is more effective. Symptoms of lower back and knee pain and cold intolerance have also improved.

[0160] Therapeutic effect evaluation: Significantly effective.

[0161] The composition prepared in Example 1 was used twice daily, morning and evening, for brushing teeth. Improvement was observed after 7 days of treatment: the tooth sensitivity index (Schiff) decreased from 3 to 2, sensitivity to cold water stimulation decreased, the soreness during inhalation lessened, and the pain score (VAS) decreased from 6 to 3. After 14 days of treatment, the tooth sensitivity index decreased to 1, allowing normal rinsing with cold water and no discomfort when eating sweet and sour fruits (VAS=1), and chewing became more effective. After 30 days of treatment, tooth sensitivity essentially disappeared (Schiff=0), pain completely disappeared (VAS=0), and symptoms such as lower back and knee weakness and aversion to cold improved simultaneously. The TCM syndrome score decreased from 18 to 4, reaching the standard for significant efficacy. This case fully demonstrates that the composition is effective for tooth sensitivity caused by kidney yang deficiency (kidney deficiency and tooth loosening syndrome). Through multiple mechanisms such as tonifying the kidneys and strengthening teeth, warming the kidneys and assisting yang, and dispelling cold and relieving pain, it fundamentally improves the problem of teeth being sore and cold due to lack of warmth. While repairing tooth sensitivity, it also addresses systemic symptoms such as soreness in the waist and knees, fear of cold and fatigue, achieving both symptomatic and root-cause treatment.

[0162] Case 7: Radiation-induced oral mucositis (post-radiotherapy for head and neck cancer)

[0163] General information: Patient Zhang, male, 58 years old, 4 weeks into radiotherapy for nasopharyngeal carcinoma, first visit on July 15, 2024.

[0164] Chief complaint: Toothache for 10 days.

[0165] Present illness: Toothache began in the third week of radiotherapy for nasopharyngeal carcinoma, accompanied by congestion and erosion of the oral mucosa.

[0166] Comparative example: Four diagnostic methods in Traditional Chinese Medicine: Observation: Red tongue with little coating; Auscultation: Foul odor in the mouth; Inquiry: Severe pain when swallowing; Palpation: Thready and rapid pulse.

[0167] Traditional Chinese Medicine diagnosis: Toothache, canker sores (due to excessive heat and toxins)

[0168] Prescription: 15g coarse salt, 15g gypsum, 12g psoralea corylifolia, 5g Sichuan pepper (seeds removed), 5g angelica dahurica, 8g peppermint, 8g eclipta prostrata, 8g saposhnikovia divaricata, 3g asarum sieboldii. Grind the herbs into powder and apply externally, or use as a mouthwash for 2 minutes, once daily.

[0169] Second visit on July 21, 2024: Toothache has not been significantly relieved; oral ulcers and pain have worsened for 3 days, now developing into multiple ulcers with severe pain, making it impossible to eat, only able to consume liquids. Previously used Kangfuxin liquid and lidocaine mouthwash, but with poor results.

[0170] Example: Four diagnostic methods in Traditional Chinese Medicine: Inspection: Multiple ulcers on the buccal mucosa, underside of the tongue, and soft palate, covered with a yellowish-white pseudomembrane, surrounded by congestion; dark red tongue with little coating; Auscultation: A putrid odor in the mouth; Inquiry: Dry mouth and throat, severe pain when swallowing, fatigue, shortness of breath, and reluctance to speak; Palpation: Thready and rapid pulse.

[0171] Traditional Chinese Medicine diagnosis: Toothache, oral ulcers (heat toxin scorching the yin).

[0172] Pathogenesis analysis: Radiotherapy is an external attack of "heat toxins" that burns the mucous membranes; in addition, cancer patients are already deficient in qi, and the heat toxins damage yin, resulting in deficiency of both qi and yin, malnourishment of the mucous membranes, and ulceration that is difficult to heal.

[0173] Prescription: Use the composition prepared in Example 1, apply lightly to the affected area 4-6 times daily, then rinse with the mouth for about 2 minutes. If necessary, apply once more before bedtime.

[0174] Quantitative indicators: Before treatment: Oral mucositis grade (WHO) = grade 3 (ulcer, only able to eat liquids), pain score (VAS) = 9 points, oral pain affecting eating score = 4 points (0-4 points, 4 points = completely unable to eat).

[0175] Three days after treatment: VAS score = 5, semi-liquid diet can be started slowly.

[0176] After 7 days of treatment: WHO classification = 1 (erythema, mild pain), VAS = 2 points, eating score = 1 point (can eat soft food). After 14 days of treatment: mucosa basically healed, VAS = 0 points, normal eating.

[0177] Therapeutic effect observation: Three days after taking the medication: The patient reported that the pain was significantly reduced and the congestion around the ulcer was reduced, and the patient could try eating porridge.

[0178] Seven days after medication: the ulcer shrinks, the pseudomembrane falls off, new mucosa grows, and the patient can eat soft foods such as noodles and steamed buns.

[0179] Fourteen days after medication: the mucosa healed completely, and the radiotherapy was successfully completed.

[0180] Therapeutic effect evaluation: Significant effect. Astragalus in the formula replenishes qi and supports detoxification, promoting ulcer healing; Bletilla striata forms a protective film and reduces food irritation; Gypsum clears residual heat; Drynaria fortunei and Eclipta prostrata nourish the kidneys and replenish yin, which is in line with the overall treatment principle of "strengthening the body's resistance and eliminating pathogenic factors" for cancer patients.

[0181] The comparative study used a powdered traditional Chinese medicine mixture including coarse salt, gypsum, psoralea, asarum, and Sichuan pepper for external application, followed by rinsing once daily. The result was no relief of toothache; instead, it worsened oral ulceration, leading to multiple ulcers, inability to eat, and a deterioration of the condition. In contrast, the example study used the composition prepared in Example 1, lightly applied to the affected area and rinsed 4-6 times daily. Significant improvement was observed after 3 days of treatment: the oral mucositis grade (WHO) remained at 3, but pain was significantly relieved; the pain score (VAS) decreased from 9 to 5; the patient could slowly consume semi-liquid foods; and the oral pain affecting eating score decreased from 4 (completely unable to eat) to being able to eat with difficulty. After 7 days of treatment, the mucositis grade decreased to 1 (only erythema and mild pain), the VAS decreased to 2, the eating score improved to 1 (able to eat soft foods such as noodles and steamed buns), the ulcer surface shrank, the pseudomembrane sloughed off, and new mucosa began to grow. Fourteen days after treatment, the mucosa was almost completely healed, the VAS score dropped to 0, the patient resumed normal eating, and successfully completed the subsequent radiotherapy.

[0182] This case fully demonstrates that, compared to traditional formulations, this composition has a significant therapeutic effect on radiation-induced oral mucositis (Qi and Yin deficiency, heat toxicity burn syndrome) caused by radiotherapy. While rapidly relieving severe pain and promoting ulcer healing, this composition also addresses the underlying Qi and Yin deficiency in cancer patients, embodying an organic combination of local treatment and systemic conditioning. It provides an ideal adjuvant therapy for head and neck cancer radiotherapy patients, effectively relieving oral mucositis, improving quality of life, and ensuring the smooth completion of radiotherapy.

[0183] Case 8: Chemotherapy-related oral mucositis (breast cancer chemotherapy)

[0184] General information: Patient Li, female, 45 years old, is in the second cycle of chemotherapy after breast cancer surgery. She first visited the hospital on August 10, 2024.

[0185] Tumor diagnosis: Invasive ductal carcinoma of the left breast, T2N1M0, stage IIB, currently receiving TAC chemotherapy regimen (docetaxel + doxorubicin + cyclophosphamide).

[0186] Chief complaint: Oral pain and ulceration for 5 days.

[0187] Present illness: On the 7th day after chemotherapy, the patient experienced oral mucosal congestion and pain. On the 9th day, multiple ulcers appeared, affecting eating; the patient could only consume liquids. Similar symptoms had occurred in previous chemotherapy cycles, lasting 10-14 days and resolving spontaneously.

[0188] Traditional Chinese Medicine Four Diagnostic Methods: Inspection: Multiple ulcers on both cheeks and the inner side of the lower lip, surrounded by redness; red tongue with yellow and greasy coating; Inquiry: Dry mouth, bitter taste, constipation, and fatigue; Palpation: Slippery and rapid pulse.

[0189] Traditional Chinese Medicine diagnosis: Oral ulcers (excessive heat and toxins, damage to Qi and Yin).

[0190] Quantitative indicators: Before treatment: VAS = 8 points, eating ability score = 4 points (only liquid food can be consumed), oral mucosal inflammation area = 350 mm², pain affecting sleep score = 3 points (0-4 points, 4 points = completely unable to fall asleep).

[0191] After 3 days of treatment: VAS = 4 points, eating ability score = 3 points (able to eat semi-liquid food), mucosal area = 200 mm², sleep impact score = 1 point.

[0192] After 7 days of treatment: VAS = 1 point, eating ability score = 2 points (can eat soft food), mucosal area = 60 mm², sleep impact score = 0 points.

[0193] 14 days after treatment: VAS score = 0, eating ability score = 1 (normal eating), mucosal area = 0 mm².

[0194] Safety indicators: Platelets: 210 before treatment → 198 after treatment (normal); Liver and kidney function: all within the normal range; Adverse events: none.

[0195] Therapeutic effect evaluation: Significantly effective.

[0196] The composition prepared in Example 1 showed significant improvement after 3 days of treatment: the pain score (VAS) decreased from 8 to 4, the eating ability score improved from 4 (only liquid food) to 3 (semi-liquid food), the area of ​​oral mucositis decreased from 350 mm² to 200 mm², and the pain-related sleep impact score decreased from 3 (complete insomnia) to 1. After 7 days of treatment, the VAS further decreased to 1, the eating ability improved to 2 (soft food), the mucosal area decreased to 60 mm², and the sleep impact score was 0, allowing the patient to sleep soundly at night. After 14 days of treatment, the mucosa was completely healed (area = 0 mm²), the VAS score was 0, and the patient resumed normal eating. This case fully demonstrates that the composition has a significant therapeutic effect on chemotherapy-induced oral mucositis (heat toxicity and qi and yin deficiency syndrome). Through multiple mechanisms including clearing heat and detoxifying, cooling blood and stopping bleeding, promoting wound healing and tissue regeneration, and nourishing qi and yin, this product not only rapidly relieves pain and promotes ulcer healing, but also effectively improves patients' eating ability and sleep quality, significantly enhancing their quality of life. This composition is made from all-natural ingredients, is applied topically, and has no adverse effects on platelets or liver and kidney function, demonstrating good safety.

[0197] Case 9: Thrombocytopenia with gingival bleeding (bone marrow suppression after chemotherapy for lung cancer)

[0198] General information: Patient Wang, male, 62 years old, had undergone chemotherapy for lung adenocarcinoma and was first visited on September 5, 2024.

[0199] Tumor diagnosis: Stage IV adenocarcinoma of the left lung, EGFR negative, currently undergoing pemetrexed + carboplatin chemotherapy, 12 days post-chemotherapy.

[0200] Chief complaint: Spontaneous bleeding of the gums for 3 days.

[0201] Present Illness: Spontaneous gingival bleeding began on the 10th day after chemotherapy, with bloodstains visible on the pillowcase upon waking. Bleeding worsened when brushing teeth, accompanied by fatigue and dizziness. Blood tests showed a platelet count of 52 × 10⁻⁶. 9 / L.

[0202] Traditional Chinese Medicine Four Diagnostic Methods: Observation: Pale gums with bloodstains at the gum line; pale and swollen tongue with teeth marks on the edges; white tongue coating. Inquiry: Fatigue, shortness of breath, reluctance to speak, and poor appetite. Palpation: Thready and weak pulse.

[0203] Traditional Chinese Medicine diagnosis: Gut bleeding (due to Qi deficiency and inability to retain Qi, and spleen deficiency and inability to control Qi).

[0204] Quantitative indicators: Before treatment: Platelet count (PLT) = 52 × 10⁻⁶ 9 / L, Gingival Bleeding Index (BI) = 3, Bleeding Time = Continuous Bleeding, Bleeding Amount Assessment = Moderate (Fresh bloodstains visible in the morning), Traditional Chinese Medicine Syndrome Score = 24 points.

[0205] Three days after treatment: PLT = 58 × 10 9 / L, BI=2, bleeding time = reduced by 80%, bleeding volume assessment = mild (only a small amount of bleeding when brushing teeth), TCM syndrome score = 18 points.

[0206] 7 days after treatment: PLT = 76 × 10 9 / L, BI=1, bleeding time=normal range, bleeding volume assessment=occasionally blood streaks, TCM syndrome score=12 points.

[0207] 14 days after treatment: PLT = 95 × 10 9 / L, BI=0, bleeding time=normal, bleeding volume assessment=no bleeding, TCM syndrome score=6 points.

[0208] Safety indicators: Liver and kidney function: within normal range; adverse events: none.

[0209] Therapeutic effect evaluation: Effective.

[0210] The composition prepared in Example 1 showed improvement after 3 days of treatment: platelet count (PLT) decreased from 52 × 10⁻⁶. 9 / L rose to 58×10 9 / L, the gingival bleeding index (BI) decreased from 3 to 2, bleeding time decreased by approximately 80%, and bleeding volume decreased from moderate (fresh bloodstains visible in the morning) to mild (minor bleeding only during brushing). The TCM syndrome score decreased from 24 to 18. After 7 days of treatment, PLT increased to 76×10 9 / L, BI decreased to 1, bleeding time returned to normal range, occasional blood streaks were observed, and symptoms such as fatigue, shortness of breath, and reluctance to speak improved. The TCM syndrome score decreased to 12 points. After 14 days of treatment, PLT further increased to 95×10 9 / L, BI decreased to 0, gingival bleeding completely stopped, no spontaneous bleeding, no impact on eating or brushing teeth, and the TCM syndrome score decreased to 6 points. This case fully demonstrates that the composition has a significant effect on gingival bleeding (Qi deficiency and failure to control blood flow) caused by bone marrow suppression after chemotherapy. Through multiple mechanisms of invigorating Qi and controlling blood flow, strengthening the spleen and controlling blood, and cooling blood and stopping bleeding, it not only rapidly controls gingival bleeding locally, but also has a positive effect on the recovery of systemic platelet count, reflecting the synergistic effect of local medication and systemic conditioning.

[0211] Case 10: Oral ulcers related to targeted therapy (lung cancer EGFR-TKI)

[0212] General information: Patient Chen, female, 55 years old, is undergoing targeted therapy for lung adenocarcinoma and first visited on October 12, 2024.

[0213] Tumor diagnosis: Stage IV adenocarcinoma of the right lung, EGFR 19del, oral osimertinib 80mg / day, for the 3rd month.

[0214] Chief complaint: Recurrent oral ulcers for 2 months, worsening in the past week.

[0215] Present illness: Recurrent oral ulcers began to appear one month after taking osimertinib, occurring 2-3 times per month, each lasting 1-2 weeks. The ulcers have worsened in the past week, and the pain has affected eating.

[0216] Traditional Chinese Medicine Four Diagnostic Methods: Inspection: Multiple ulcers on the inner side of the lower lip and the edge of the tongue, 3-5 mm in diameter, with redness around them; red tongue with little coating; Inquiry: Dry mouth and throat, five-center heat (palms, soles, and chest), insomnia and excessive dreaming; Palpation: Thready and rapid pulse.

[0217] Traditional Chinese Medicine diagnosis: oral ulcers (yin deficiency with excessive fire and internal accumulation of heat toxins).

[0218] Quantitative indicators: Before treatment: Number of ulcers = 4, total ulcer area = 45 mm², VAS = 6 points, recurrence frequency = 2-3 times / month, oral health impact score (OHIP-14) = 32 points, TCM syndrome score = 20 points.

[0219] After 7 days of treatment: number of ulcers = 2, total area = 15 mm², VAS = 2 points, OHIP-14 = 18 points, TCM syndrome score = 12 points.

[0220] After 14 days of treatment: number of ulcers = 0, total area = 0 mm², VAS = 0 points, OHIP-14 = 8 points, TCM syndrome score = 6 points.

[0221] Follow-up for 1 month: ulcer recurrence = 0 times, maintaining an ulcer-free state.

[0222] Safety indicators: Liver and kidney function: within normal range; adverse events: none.

[0223] Therapeutic effect evaluation: Significantly effective.

[0224] The composition prepared in Example 1 showed significant improvement after 7 days of treatment: the number of ulcers decreased from 4 to 2, the total area decreased from 45 mm² to 15 mm², the pain score (VAS) decreased from 6 to 2, the oral health impact score (OHIP-14) decreased from 32 to 18, and the TCM syndrome score decreased from 20 to 12. After 14 days of treatment, the ulcers were completely healed (0 ulcers, 0 mm² total area), the VAS score decreased to 0, the OHIP-14 score decreased to 8, and the TCM syndrome score decreased to 6. During a one-month follow-up, there were 0 ulcer recurrences, and the patient remained ulcer-free, demonstrating a sustained and stable therapeutic effect. This case fully demonstrates that the composition has a significant therapeutic effect on oral ulcers (Yin deficiency with internal heat and toxin accumulation) caused by targeted drugs (EGFR-TKI). Through multiple mechanisms of nourishing Yin and reducing fire, clearing heat and detoxifying, and promoting tissue regeneration, it effectively reduces the recurrence frequency while rapidly promoting ulcer healing and relieving pain, achieving a balance between short-term efficacy and long-term control.

[0225] Case 11: Radiation-induced xerostomia with susceptibility to dental caries (late stage of radiotherapy for head and neck cancer)

[0226] General information: Patient Liu, male, 65 years old, 6 months after radiotherapy for laryngeal cancer, first visit on November 8, 2024.

[0227] Tumor diagnosis: Laryngeal squamous cell carcinoma T3N0M0, 6 months after radiotherapy (cumulative dose 70Gy).

[0228] Chief complaint: Tooth sensitivity and multiple cavities.

[0229] Present illness: Persistent dry mouth after radiotherapy, requiring frequent drinking day and night, teeth sensitive to hot, cold, sour and sweet, and 3 new cavities developed within 6 months.

[0230] Comparative Example: Four Diagnostic Methods in Traditional Chinese Medicine: Inspection: Dry oral mucosa, receding gums, exposed tooth roots, dark red tongue, and cracked tongue; Inquiry: Dry mouth with thirst, soreness and weakness in the lower back and knees, and frequent urination at night; Palpation: Deep and thready pulse.

[0231] Traditional Chinese Medicine diagnosis: Dental caries (due to kidney deficiency and loose teeth).

[0232] Prescription: 15g coarse salt, 15g gypsum, 12g psoralea corylifolia, 5g Sichuan pepper (seeds removed), 5g angelica dahurica, 8g peppermint, 8g eclipta prostrata, 8g saposhnikovia divaricata, 3g asarum sieboldii. Grind the herbs into powder and apply externally, or use as a mouthwash for 2 minutes, once daily.

[0233] On November 20, 2024, during the second consultation, the patient reported that there was no significant improvement in the sensitivity of teeth to hot, cold, sour, and sweet tastes. After rinsing the mouth, the patient always wanted to drink water to moisten the mouth and clear the throat, but there was no mucosal ulceration, cough, or wheezing.

[0234] Example: Four diagnostic methods in Traditional Chinese Medicine: Inspection: Dry and dull oral mucosa, receding gums, exposed tooth roots, dark red tongue, cracked tongue, little saliva; Inquiry: Dry mouth with thirst, difficulty swallowing dry food, soreness and weakness of the lower back and knees, frequent urination at night; Palpation: Deep and thready pulse.

[0235] Traditional Chinese Medicine diagnosis: Dental caries (due to kidney deficiency and loose teeth).

[0236] Quantitative indicators: Before treatment: Tooth sensitivity index (Schiff) = 3, Traditional Chinese Medicine syndrome score = 28 points, Oral Health Impact Scale (OHIP-14) score = 38 points.

[0237] After 14 days of treatment: Schiff=2, TCM syndrome score=22 points, OHIP-14=30 points.

[0238] After 30 days of treatment: Schiff=1, TCM syndrome score=16 points, OHIP-14=22 points.

[0239] After 60 days of treatment: Schiff=1, TCM syndrome score=12 points, OHIP-14=16 points.

[0240] Safety indicators: Liver and kidney function: within normal range; adverse events: none.

[0241] Therapeutic effect evaluation: Effective (symptoms significantly improved, but not fully recovered to normal levels).

[0242] The comparative study used a powdered traditional Chinese medicine mixture including coarse salt, gypsum, psoralea, asarum, and Sichuan pepper for external application, followed by rinsing once daily. The results showed no significant improvement in tooth sensitivity to hot, cold, sweet, and sour stimuli, with symptoms such as dry mouth, thirst, and throat clearing persisting. In contrast, the example study used the composition prepared in Example 1. After 14 days of treatment, improvement was observed: the Schiff index decreased from 3 to 2, dry mouth symptoms were slightly relieved, nighttime thirst decreased, the TCM syndrome score decreased from 28 to 22, and the Oral Health Impact Scale (OHIP-14) score decreased from 38 to 30. After 30 days of treatment, the Schiff index further decreased to 1, tolerance to hot, cold, sweet, and sour stimuli significantly improved, allowing normal consumption of fruits and cold drinks. The TCM syndrome score decreased to 16, the OHIP-14 score decreased to 22, and symptoms such as lower back and knee pain and frequent urination at night improved. After 60 days of treatment, Schiff's score stabilized at 1. Occasionally, there was mild discomfort due to tooth sensitivity, but it did not affect eating. Dry mouth symptoms continued to improve. The TCM syndrome score dropped to 12 points, and the OHIP-14 score dropped to 16 points. The patient's quality of life improved significantly.

[0243] This case fully demonstrates that, compared to traditional formulations, this composition is significantly effective in treating radiation-induced xerostomia and susceptibility to dental caries caused by yin deficiency and fluid depletion after radiotherapy. Through multiple mechanisms of nourishing yin and generating fluids, tonifying the kidneys and strengthening teeth, it effectively slows gingival recession and the progression of dental caries while improving dry mouth symptoms and reducing tooth sensitivity, embodying a comprehensive treatment approach. Although symptoms did not fully recover to normal levels, this composition significantly improved the patient's quality of life and oral health, providing an ideal long-term care plan for managing radiation-induced oral sequelae, preventing dental caries, and maintaining oral health for patients undergoing late-stage radiotherapy for head and neck cancer.

[0244] Statistical analysis of cases in Example 3

[0245] Safety evaluation: No abnormal changes were observed in platelet count or liver and kidney function during treatment in all cases, and no drug-related serious adverse events were observed. This indicates that the composition of the present invention has good safety and tolerability in cancer patients and can be used as an adjunct to supportive cancer treatment.

[0246] Precautions for use by cancer patients: 1. Contraindications: (1) Platelet count <20×10 9 / L patients in the severe bone marrow suppression period (at this time, any brushing or rubbing should be avoided, and it is recommended to use a cotton swab to apply the powder lightly); (2) patients who are known to be allergic to any of the medicines; (3) patients who are scheduled to undergo jaw surgery or have signs of jaw necrosis (must be used under the guidance of a doctor).

[0247] 2. Adjustment of usage: When oral mucositis is severe during radiotherapy and chemotherapy, it is recommended to switch to rinsing or applying instead of brushing. You can mix 3-5g of the powder with warm water to form a paste, rinse for 2-3 minutes and then spit it out slowly, 4-6 times a day.

[0248] Table 1: Explanation of Quantitative Indicators

[0249] Table 2: Based on the clinical characteristics of the cancer population, the following stratified efficacy evaluation criteria are recommended:

[0250] This study included 48 patients (30 ordinary cases and 18 tumor cases). After treatment, 20 cases were cured, 19 cases showed significant improvement, 7 cases showed improvement, and 2 cases showed no improvement, with a total effective rate of 95.8%. Clinical observation confirmed that the traditional Chinese medicine composition described has the effects of clearing heat and detoxifying, reducing swelling and relieving pain, nourishing yin and reducing fire, and tonifying the kidney and strengthening teeth. It can not only quickly relieve various toothaches and oral mucositis symptoms, but also exert multi-target therapeutic effects on different syndromes (excess fire, deficiency fire, qi deficiency, and yin deficiency), effectively improving the quality of life of patients, and has good safety with long-term use.

[0251] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, Made from the following parts by weight of raw materials: 12-18 parts of coarse salt, 7-12 parts of gypsum, 7-12 parts of astragalus, 9-15 parts of drynaria, 3-7 parts of Sichuan pepper, 3-7 parts of angelica, 6-10 parts of saposhnikovia, 1-5 parts of long pepper, 6-10 parts of eclipta, 1-5 parts of gallnut, and 4-8 parts of bletilla.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following parts by weight of raw materials: 14-16 parts of coarse salt, 8-10 parts of gypsum, 8-10 parts of astragalus, 10-13 parts of drynaria, 4-6 parts of Sichuan pepper, 4-6 parts of angelica dahurica, 7-9 parts of saposhnikovia divaricata, 2-4 parts of long pepper, 7-9 parts of eclipta prostrata, 2-4 parts of gallnut, and 5-7 parts of bletilla striata.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following parts by weight of raw materials: 15 parts coarse salt, 9 parts gypsum, 9 parts astragalus, 12 parts drynaria, 5 parts red Sichuan pepper, 5 parts angelica, 8 parts saposhnikovia, 3 parts long pepper, 8 parts eclipta, 3 parts gallnut and 6 parts bletilla.

4. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of oral care products.

5. The application according to claim 4, characterized in that, The oral care product has at least one of the following functions: analgesia, antibacterial, anti-inflammatory, anti-sensitivity, hemostasis, repair, assistance in improving halitosis, tartar and dental calculus, gum protection and / or tooth strengthening.

6. The application according to claim 4 or 5, characterized in that, The oral care product also includes functions to improve or treat at least one of the following: radiation-induced oral mucositis, chemotherapy-related oral mucositis, thrombocytopenia with gingival bleeding, targeted drug-related oral ulcers, or radiation-induced xerostomia with susceptibility to dental caries.

7. An oral care product, characterized in that, It includes the traditional Chinese medicine composition according to any one of claims 1 to 3, and pharmaceutically acceptable excipients.

8. The oral care product according to claim 7, characterized in that, The dosage forms of the oral care products include mouth fresheners, chewing gum, toothpaste, tooth gel, tooth powder, mouthwash, or tablets.

9. A method for preparing an oral care product, characterized in that, include: The traditional Chinese medicine composition according to any one of claims 1 to 3 is mixed and then pulverized to obtain the following: Alternatively, the traditional Chinese medicine composition described in any one of claims 1 to 3 can be pulverized and mixed to obtain the product.

10. An oral care method, characterized in that, This includes administering the traditional Chinese medicine composition according to any one of claims 1 to 3 or the oral care product according to claim 7 or 8; the administration method includes at least one of the following: rinsing, brushing, spraying or applying.

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