A combined system preparation for preventing and treating alcohol harm and a preparation method thereof

Abstract

The application discloses a combined system preparation for preventing and treating alcohol harm, and belongs to the technical field of traditional Chinese medicines. The combined system preparation is composed of sugar-free chewing gum for oral taking and external use acupoint gel ointment. The sugar-free chewing gum is prepared by using homologous medicinal and edible materials such as Flos Puerariae, can be absorbed through oral mucosa, can freshen breath, has the effects of removing alcohol toxicity, refreshing brain, calming nerves, protecting liver and stomach, and the like, relies on natural food seasoning to optimize taste, has mild medicinal properties and is suitable for long-term conditioning, realizes the combination of medicine and food, and achieves the effect of "combining medicine with food". The external use ointment is designed with special formula for five core syndromes, takes the external and internal acupoint matching method as the core, integrates various acupoint matching methods, and realizes the precise correspondence among syndromes, ointments and acupoints. The two can realize double-channel drug delivery, can quickly remove alcohol, protect and nourish viscera from multiple targets, can prevent before drinking, relieve after drinking and long-term conditioning, are in line with the TCM concept of "preventing disease before it occurs", and are suitable for acute drunkenness and long-term drinking population. The preparation process retains active ingredients at low temperature, the ointment adopts modular design, and is suitable for industrial production.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a combined system preparation for preventing and treating the harms of alcohol consumption, and also to a method for preparing the aforementioned combined system preparation. Background Technology

[0002] Currently, the global and Chinese populations of drinkers are enormous, and the incidence of long-term drinking, social drinking, and pathological drinking continues to rise. The acute and chronic health hazards caused by excessive drinking, chronic alcoholism, and alcohol dependence are increasing year by year, becoming a pressing public health challenge. Drinking not only causes chronic damage to multiple organ systems, such as alcoholic fatty liver, cirrhosis, gastrointestinal erosion and ulcers, decreased neurocognitive function, psychological dependence, cardiovascular and cerebrovascular diseases, and metabolic disorders, but it can also lead to acute harms such as acute intoxication, alcohol poisoning, alcohol-related accidents, and withdrawal syndrome. This not only increases the burden on family caregivers, consumes medical resources, and imposes a socioeconomic burden, but also seriously affects the health literacy and quality of life of the population.

[0004] Modern medical research shows that after alcohol is absorbed through the gastrointestinal tract, it is metabolized in the liver by alcohol dehydrogenase (ADH) into acetaldehyde, a highly toxic intermediate product. Acetaldehyde is then metabolized by aldehyde dehydrogenase (ALDH) into acetic acid, ultimately breaking down into CO2 and water. The accumulation of acetaldehyde in the body is the core link in alcohol-related pathogenesis. Acetaldehyde can induce oxidative stress, lipid peroxidation, and the release of inflammatory factors, causing pathological damage to multiple systems, including the liver, digestive tract, nervous system, and cardiovascular system. This damage is often progressive and irreversible. For example, alcoholic liver disease can gradually progress from alcoholic fatty liver to hepatitis, liver fibrosis, cirrhosis, and even liver cancer. Early symptoms are often insidious, and by the time it is discovered, it is usually in the middle or late stages, making treatment extremely difficult.

[0005] Traditional Chinese medicine has a long theoretical foundation regarding the pathogenic effects of alcohol. Classic medical texts such as the *Huangdi Neijing* and *Compendium of Materia Medica* clearly record that alcohol is pungent, warm, and toxic. Excessive drinking can lead to dampness, toxicity, and heat caused by alcohol, initially affecting the spleen and stomach, and gradually extending to the liver, gallbladder, heart, and kidneys. This results in internal dampness and turbidity, qi stagnation, damp-heat accumulation, qi and yin depletion, and blood stasis, ultimately causing organ deficiency and serious illness. Traditional Chinese medicine classifies the harm of alcohol into two main categories: acute alcohol toxicity and chronic alcohol damage. Different syndromes present with different clinical manifestations. The core treatment principle is to abstain from alcohol, supplemented by methods such as dispelling dampness, clearing heat, soothing the liver, strengthening the spleen, promoting blood circulation, and nourishing yin. Meanwhile, the Five Elements theory and meridian theory of traditional Chinese medicine provide important theoretical support for the treatment of the harm caused by drinking. Among them, the principles of external treatment acupoint combination, such as the combination of Yu and Mu points, upper and lower points, and distant and near points, combined with the application of core acupoints such as Baihui, Neiguan, Zhongwan, and Qimen, can achieve targeted protection of the liver and stomach, awaken the mind and calm the nerves, and relieve nausea and vomiting, providing a feasible path for external intervention of the harm caused by drinking. Food ingredients that are both food and medicine have the food safety and medicinal conditioning effects, which are in line with the concept of "treating diseases before they occur" in traditional Chinese medicine, and can be used as an ideal carrier for daily conditioning of the harm caused by drinking.

[0006] The theoretical origins and pathogenesis basis of traditional Chinese medicine

[0007] 1. Records of the properties and harms of alcohol in classic medical texts

[0008] The *Huangdi Neijing* (Yellow Emperor's Inner Classic) clearly states that "alcohol is pungent and warm in nature, and poisonous. Moderate drinking promotes blood circulation, while excessive drinking injures qi and blood, and damages the internal organs." It also introduces disease names such as "alcohol wind" and "alcohol jaundice," laying the foundation for the theory that alcohol is a pathogenic factor. Physicians throughout history (Zhang Zhongjing, Li Shizhen, Ye Tianshi, etc.) have all recorded that excessive drinking leads to dampness, toxicity, and heat from alcohol, which are considered pathogenic factors due to dietary indiscretions and are an important cause of internal injuries and miscellaneous diseases. The *Compendium of Materia Medica* states directly that "alcohol is a bounty from heaven; moderate drinking harmonizes blood and qi, strengthens the spirit and wards off cold, while excessive drinking injures the spirit, depletes blood, damages the stomach, depletes essence, and generates phlegm and internal heat."

[0009] 2. Core Pathogenesis Background in Traditional Chinese Medicine: Alcohol is pungent, sweet, and warm in nature, and toxic; excessive consumption leads to:

[0010] The spleen and stomach are the primary targets: internal dampness and turbidity lead to impaired digestion and stagnation of Qi; dampness transforms into heat, forming damp-heat accumulation, which steams the liver and gallbladder, causing hypochondriac pain, jaundice, and bitter taste in the mouth; pungent and warm substances deplete Qi, and dryness and heat injure Yin, eventually leading to deficiency of both Qi and Yin, and deficiency of the liver and kidneys; Qi stagnation and dampness obstruction hinder blood circulation, ultimately leading to blood stasis and obstruction of the collaterals, forming masses (cirrhosis, nodules) and damage to the blood vessels.

[0011] The disease is primarily located in the spleen, stomach, liver, and gallbladder, gradually extending to the heart, kidneys, brain, and blood vessels. The nature of the disease changes from excess (dampness, heat, qi stagnation) to a mixture of deficiency and excess (qi deficiency, yin deficiency, blood stasis), which is the core theoretical basis for TCM to treat alcohol-related injuries and detoxify alcohol.

[0012] The shortcomings and limitations of existing intervention techniques in modern medicine and traditional Chinese medicine

[0013] Currently, modern Western medicine mainly focuses on symptomatic treatment. Commonly used alcohol addiction medications have significant side effects and poor patient compliance. Measures such as liver protection, anti-inflammatory drugs, and gastric mucosa protection cannot fundamentally reverse the organ dysfunction caused by chronic alcohol damage, and there is a lack of long-term solutions for the physical repair of long-term drinkers.

[0014] Traditional Chinese medicine preparations have been widely used in the field of hangover relief and health maintenance due to their inherent advantages of addressing both the symptoms and root cause, having fewer side effects, and being suitable for long-term conditioning. Currently, there are various hangover relief Chinese herbal teas, external acupoint plasters, and other related products on the market.

[0015] In existing technologies, traditional Chinese medicine preparations for relieving hangovers are mainly divided into two categories: oral and external. Among them, oral preparations are mostly aimed at relieving alcohol poisoning. For example, Chinese patent CN112316987A discloses a traditional Chinese medicine tea for relieving hangovers and protecting the stomach. It is made from kudzu root, kudzu flower, and Japanese raisin tree fruit as the main raw materials, supplemented with tangerine peel and poria cocos. It is used to relieve gastrointestinal discomfort and dizziness after drinking alcohol. The publication date is February 5, 2021. The 2020 edition of the Pharmacopoeia of the People's Republic of China also clearly records that kudzu root, Japanese raisin tree fruit, and kudzu flower all have the effects of relieving alcohol poisoning, promoting urination, and harmonizing the stomach and stopping vomiting. They are commonly used raw materials for traditional Chinese medicines for relieving hangovers. Topical preparations often focus on acupoint stimulation. For example, Chinese patent CN109876241A discloses an acupoint patch for relieving hangovers, which uses Acorus tatarinowii and Polygala tenuifolia as its main active ingredients. Applied to the Baihui and Neiguan acupoints, it is used to relieve dizziness and mental confusion after drinking alcohol. The publication date is June 14, 2019. While these existing technologies have some application in the field of hangover relief, they still have many limitations when considered in conjunction with the holistic conditioning theory of Traditional Chinese Medicine.

[0016] Although existing traditional Chinese medicine (TCM) preparations for relieving hangovers have achieved basic effects in alleviating hangovers and relieving discomfort, they still have many shortcomings and limitations when considered in practical application and in light of the TCM theory of "treating both internal and external factors and regulating the liver and spleen simultaneously," making it difficult to meet the comprehensive health needs of long-term drinkers. Firstly, the formulation design is too simplistic. Existing oral preparations mostly focus on detoxifying alcohol, neglecting the synergistic regulation of liver and stomach protection, liver qi regulation, and calming the mind. Long-term use can easily lead to damage to spleen and stomach function, failing to fundamentally alleviate liver stagnation and restlessness caused by long-term drinking. Secondly, existing external acupoint plasters do not incorporate the synergistic logic of TCM formulations, the selection of acupoints is not targeted enough, and they are not systematically designed with oral preparations. There is a lack of long-term conditioning solutions for chronic alcohol-induced damage, and there is a lack of integrated technology that takes into account "detoxification + regulation of internal organs + prevention of relapse," failing to achieve the effect of "synergistic internal and external factors and targeted health maintenance." Secondly, the technical effects are limited. Existing preparations are mostly for single oral or external use, and their synergistic effects of relieving hangovers, protecting the liver, and protecting the stomach are not obvious. They are not effective in relieving nausea and vomiting after acute intoxication, dizziness and insomnia after hangovers, or symptoms such as dull pain in the liver area and gastrointestinal distension caused by long-term drinking. Some oral preparations do not specify the key parameters of the processing technology of the medicinal materials, such as the processing ratio of vinegar-processed Bupleurum chinense and the thickness of the slices of Pueraria lobata, resulting in insufficient extraction of effective components and affecting the efficacy of the preparations. Thirdly, the suitability is poor. Existing preparations do not fully consider the differences in the constitution of long-term drinkers. Some oral preparations are too cold or too hot in nature, which can easily lead to imbalances in conditioning with long-term use. Moreover, the dosage forms are relatively simple, mostly ordinary teas or plasters, which cannot meet the needs of different groups of people.

[0017] In summary, the acute and chronic harms caused by alcohol consumption have posed a serious health threat to society. Existing intervention technologies cannot meet the clinical and public needs for detoxification, liver protection, treatment of alcohol-related damage, and reduction of alcohol harm. Therefore, developing a combined systemic formulation that integrates traditional Chinese medicine's diagnostic theories, the principles of external treatment through meridians and acupoints, the advantages of food and medicine homology, and the mechanisms of alcohol damage in modern medicine, while being highly safe, widely applicable, easy to operate, and easy to adhere to long-term, and capable of achieving integrated intervention of "detoxification of alcohol, regulation of internal organs, and prevention of relapse," thus filling the technological gap in the systematic treatment of chronic alcohol-related damage using traditional Chinese medicine, has become an urgent technical problem to be solved. Summary of the Invention

[0018] Addressing the core shortcomings of existing hangover remedies: single oral or external dosage forms limit efficacy to "simple hangover relief," failing to address organ regulation and relapse prevention; external formulations suffer from unclear acupoint targeting and chaotic acupoint combination logic, failing to align with the pathogenesis of alcohol damage; oral formulations are mostly traditional dosage forms such as tablets, effervescent tablets, and capsules, requiring water for administration, having poor adaptability to various scenarios, bitter taste, and insufficient raw material safety, and focusing solely on hangover relief, making them difficult for the public to accept long-term. This invention breaks through the limitations of existing technology, providing a combined system formulation for preventing and treating the harms of alcohol consumption and its preparation method. Through multi-dimensional innovation in raw material selection, dosage form innovation, taste optimization, acupoint combination, and drug delivery mechanism, especially by prioritizing a sugar-free chewing gum-like oral formulation and achieving a breakthrough design in acupoint combination, it constructs an integrated prevention and treatment system of "hangover detoxification + organ regulation + relapse prevention," significantly differentiating itself from existing technologies, possessing outstanding substantive features and significant progress, and providing a healthy, natural, safe, effective, and non-toxic prevention and treatment solution for drinkers. The inventiveness of this invention lies in its multi-dimensional technological breakthroughs, with each innovative point working synergistically to form a core technological system that distinguishes it from existing technologies, as detailed below:

[0019] I. The primary creative innovation of this invention lies in its disruptive innovation in dosage form selection and scenario adaptability:

[0020] Existing oral hangover remedies (such as tablets, capsules, and oral liquids) generally have limitations in terms of application scenarios: they are inconvenient to take in immediate situations such as drinking parties, social gatherings, and driving (requiring water to be swallowed), and they cannot simultaneously address the essential need for fresh breath after drinking. This invention creatively and preferably uses sugar-free chewing gum as the core dosage form of the oral preparation. This choice is not a simple dosage form replacement, but rather based on the following in-depth technical considerations, solving the problems of "usage compliance" and "immediacy" that existing technologies cannot overcome:

[0021] 1. Extreme scene adaptability: The chewing gum form does not require water and can be chewed and used anytime and anywhere. It is perfectly suited for immediate scenarios where it is inconvenient to mix and drink, such as at a dinner party, social gathering, office, or while driving. It achieves "invisibility" and "convenience" in prevention and control, greatly increasing users' actual willingness and frequency of use, which is unmatched by tablets, effervescent tablets and other dosage forms.

[0022] 2. Dual Function Integration: While achieving core effects such as hangover relief, liver protection, and organ regulation, the chewing process naturally cleans the oral cavity and releases a fresh plant fragrance (such as rose and dried tangerine peel), naturally integrating the dual functions of "hangover relief" and "fresh breath". This directly addresses the pain points after drinking and socializing, creating a composite value that single-function products do not possess.

[0023] 3. Advantage of rapid onset of action: The active ingredients are directly absorbed through the oral mucosa, partially bypassing the first-pass metabolism of the liver, reducing the degradation and loss of the drug in the gastrointestinal tract and liver, improving bioavailability, and the onset of action is faster than ordinary tablets and capsules that need to be digested and absorbed through the gastrointestinal tract. It can relieve the discomfort after drinking more quickly and meet the need for "instant hangover relief".

[0024] 4. Balance of safety and palatability: This invention selects medicinal and edible ingredients such as kudzu flower, bitter orange seed, dried tangerine peel, and rose petals, which have pleasant aromas and flavors highly compatible with the chewing characteristics of chewing gum. Through a "natural blend of natural ingredients," it avoids the bitter taste of traditional Chinese medicine for relieving hangovers and uses a sugar-free formula, which is more in line with modern health trends and expands the target audience.

[0025] Second, the second inventive aspect of this invention lies in the synergistic innovation of raw material screening and the combination of "oral + external" dosage forms:

[0026] Based on the optimized chewing gum dosage form, this invention further precisely selects medicinal materials from the National List of Food and Medicine with the Same Origin, and innovatively combines them with a topical acupoint gel ointment (Babu plaster). This system of "oral administration (chewing gum) + acupoint treatment (ointment)" constructs a three-dimensional prevention and treatment network that "treats the root cause by regulating the internal organs, treats the symptoms by addressing acute conditions, and enhances efficacy through synergistic effects of medicine and acupoints." The oral chewing gum focuses on daily conditioning and long-term repair of organ functions, while the topical ointment targets acute symptoms and specific syndromes with acupoint-targeted intervention. The two complement each other functionally and are sequentially linked, jointly breaking through the limitations of existing technologies such as "single dosage form, isolated pathway, and disconnect between prevention and treatment."

[0027] Third, the most core and prominent substantive feature of this invention lies in the systematic innovation of acupoint selection and acupoint combination methods for external application of traditional Chinese medicine preparations:

[0028] This invention completely solves the industry pain points of existing external hangover relief products, namely "illogical acupoint selection, inaccurate targeting, and superficial effects." This invention is not a simple accumulation of acupoints, but rather, based on in-depth research into the pathogenesis of alcohol-related harm—"from the surface to the interior, damaging both internal organs"—it is the first to creatively integrate and synergistically apply the Yu-Mu acupoint selection method, the distal-proximal acupoint selection method, and the upper-lower acupoint selection method according to the dynamic logic of "treating the symptoms in acute cases, addressing the root cause in chronic cases, and harmonizing the whole body." It precisely matches these methods to key acupoint groups in the upper, middle, and lower parts of the body, forming a three-in-one targeted external treatment system of "pathogenesis-acupoint-acupoint selection method." This system can achieve a unified approach of rapid relief of local symptoms and deep regulation of internal organ function. Its design logic and technical effects are beyond the direct conceived or combination of those skilled in the art based on existing technological inspirations.

[0029] In summary, this invention achieves its goals through:

[0030] 1. Innovative dosage form and application scenarios (selecting sugar-free chewing gum to address the pain points of portability, immediacy, and bad breath);

[0031] 2. Innovative system combination (oral chewing gum + topical ointment, synergistic effect of internal and external treatment);

[0032] 3. Innovation in external treatment theory (three-in-one acupoint combination method for precise targeting);

[0033] 4. Innovative ingredient flavor (medicinal and edible ingredients, naturally blended, highly palatable),

[0034] These four dimensions of innovation support each other and synergistically enhance each other, effectively solving the comprehensive technical problems of existing hangover remedies, such as single efficacy, poor palatability, inconvenient use, limited external application effects, and inability to systematically prevent recurrence. This invention not only provides a product, but also a complete solution covering prevention, immediate intervention, and long-term conditioning. Compared with existing technologies, its technical solution has outstanding substantive features and significant progress, and possesses extremely high inventiveness.

[0035] Based on this, one of the objectives of this invention is to provide a combined system formulation for preventing and treating the harms of alcohol consumption. This formulation consists of an oral sugar-free chewing gum preparation and an external acupoint gel ointment (Babu plaster). The raw materials are all selected from medicinal and edible herbs or commonly used Chinese medicines, which are safe, reliable, palatable, and have comprehensive effects. In particular, through the scenario-based innovation of the oral dosage form and the systematic innovation of the external acupoint combination method, the two formulations work synergistically and complement each other to achieve integrated prevention and treatment of alcohol poisoning, regulating the internal organs, and preventing relapse, which is significantly different from the existing technology.

[0036] The second objective of this invention is to provide a method for preparing the above-mentioned combined system formulation. This method is stable and of controllable quality, and in particular includes the molding process of the sugar-free chewing gum and the preparation process of the gel paste. It can effectively retain the active ingredients, ensure the efficacy of prevention and treatment and the user experience, and is suitable for industrial production.

[0037] In response to the etiological and pathological characteristics of the harmful effects of alcohol consumption, this invention discloses a combined systemic formulation for preventing and treating the harmful effects of alcohol consumption, comprising two parts: oral sugar-free chewing gum and topical acupoint gel ointment (Babu ointment).

[0038] A. Sugar-free chewing gum for oral consumption

[0039] This invention relates to sugar-free chewing gum, based on the theory of food and medicine sharing the same origin. The core advantage of this theory lies in its ingenious integration of the long-term safety of food with the specific conditioning effects of medicinal herbs, achieving "medicine within food, and a combination of food and nutrition." This approach perfectly aligns with the core concept of "preventive treatment" in Traditional Chinese Medicine, serving not only as a daily source of nutrition but also providing gentle and continuous conditioning of bodily functions. Its specific advantages are mainly reflected in the following four aspects:

[0040] 1. Mild medicinal properties, broad-spectrum safety, suitable for long-term conditioning: The medicinal and edible ingredients have been verified through long-term consumption and application, demonstrating mild effects, extremely low toxicity and side effects, and wide applicability. Compared to conventional medicinal ingredients, it is more suitable for daily maintenance by healthy individuals and continuous conditioning for those with sub-health conditions related to unhealthy lifestyles. It can effectively reduce the potential risks associated with long-term or excessive use, exhibiting outstanding safety and universality.

[0041] 2. Flexible dosage forms, convenient and easy to use, significantly improving compliance: Food and medicine homologous raw materials can be flexibly prepared into a variety of portable dosage forms, without complicated decoction processes and strict administration conditions. The usage scenarios are not limited, greatly improving the convenience of use and population compliance, integrating health conditioning into daily life, and better adapting to the modern fast-paced lifestyle.

[0042] 3. Synergistic Nutrition and Efficacy, Balancing Nourishment and Functional Regulation: Existing oral hangover remedies generally suffer from bitterness, unpleasant taste, and low public acceptance. Even when flavoring ingredients are added, they are mostly artificial sweeteners, failing to balance taste and safety. This invention innovatively selects natural medicinal and edible ingredients such as jujube (sweet), rose (fragrant), and dried tangerine peel (fragrant and dry) as flavoring ingredients. These not only naturally neutralize the slight bitterness of other herbs, giving the sugar-free chewing gum a natural jujube, rose, and dried tangerine peel aroma, but also provide a mild and palatable taste with a light medicinal flavor, perfectly meeting the taste requirements of chewing gum. Simultaneously, it replenishes the body's nutrients, achieving a unity of "efficacy + taste + nutrition," solving the technical pain points of existing hangover remedies—bitterness, strong medicinal flavor, and difficulty in long-term use. This optimized design is not simply about adding ingredients, but a targeted breakthrough in addressing the taste defects of existing preparations by combining the characteristics of the chewing gum dosage form, significantly improving the product's acceptance and user experience. Food and medicine ingredients are rich in nutrients such as polysaccharides, amino acids, vitamins, and minerals, as well as various bioactive substances such as flavonoids, alkaloids, and volatile oils. They can supplement the body's nutrition while playing a targeted regulatory role, achieving the dual value of nutritional supplementation and functional regulation, and achieving a conditioning effect that addresses both the symptoms and the root cause.

[0043] 4. Prevention-oriented, combining prevention and treatment, highlighting the concept of preventing disease before it occurs: With "preventing disease before it occurs and preventing its progression once it has occurred" as its core, this approach involves continuous and gentle intervention to preemptively enhance organ function and improve the body's defense and self-repair capabilities, implementing early conditioning before adverse factors cause organic damage. Compared to remedial treatment after the fact, this approach is more forward-looking, economical, and scientific, representing a typical practical form of TCM preventive medicine.

[0044] This invention is based on the theory of food and medicine sharing the same origin, combined with the chewing and mucosal absorption characteristics of sugar-free chewing gum, to optimize the core formula of sugar-free chewing gum for preventing the harm of alcohol consumption. The raw materials and their weight ratios are as follows: 1-4 parts kudzu flower, 1-4 parts dried kudzu root, 1-4 parts Japanese raisin tree fruit, 1-4 parts acorus tatarinowii rhizome, 0.5-1 part vinegar-processed bupleurum root, 0.5-1 part dried tangerine peel, 0.5-1 part poria cocos, 0.5-1 part dried jujube (pitted), and 0.1-0.5 parts rose flower. The formula follows traditional Chinese medicine theory, combined with modern pharmacological research and the taste and absorption requirements of chewing gum. It features clear distinctions between principal, assistant, and adjuvant herbs, rigorous compatibility, and clear synergistic effects. The core of the formula is a conditioning system of "triple hangover relief + multi-target nourishment + meridian-guided targeting + mild medicinal properties." All raw materials are suitable for chewing, have no unpleasant taste or bitterness, and are highly compatible with the chewing gum form.

[0045] In this formula: 1. Kudzu flower, dried kudzu root, and bitter orange peel are the three principal herbs. These three herbs work synergistically to form the core efficacy system of this sugar-free chewing gum, which detoxifies alcohol, refreshes the mind, and clears the head. This is the key innovation that distinguishes this invention from existing technologies, and it is also the core foundation for achieving rapid, efficient, and comprehensive detoxification. It also adapts to the mucosal absorption characteristics of sugar-free chewing gum. Kudzu flower has a prominent detoxification and refreshing effect, addressing acute discomfort such as drunkenness, nausea, and vomiting by inhibiting alcohol absorption and activating metabolic enzymes, thus improving the slow onset of action in existing products. Dried kudzu root, as a guiding herb, assists kudzu flower in enhancing its detoxification effect, while also protecting the stomach, promoting saliva production, and relieving post-drinking dizziness and gastrointestinal discomfort. Its guiding properties direct the medicinal effects directly to the spleen, stomach, and lung meridians, improving the targeting of detoxification and stomach protection, and addressing the problem of dispersed efficacy in existing products. Furthermore, its delicate texture does not affect the chewing experience of the gum. Bitter orange peel excels at detoxifying alcohol and promoting diuresis, accelerating the metabolism and excretion of alcohol and dampness, and reducing blood alcohol concentration, thereby reducing liver and stomach damage at its root. The three components work synergistically to form a triple hangover relief mechanism that inhibits absorption, accelerates metabolism, and promotes excretion. Compared to a single hangover relief component, this mechanism is more comprehensive and effective. Furthermore, all three components are mild-smelling medicinal and edible ingredients, which are suitable for the taste requirements of chewing gum formulations. This is one of the core innovations of this invention.

[0046] 2. Using Acorus tatarinowii and Bupleurum chinense (processed with vinegar) as assistant herbs to enhance the efficacy of the principal herb, this invention addresses both the need to refresh and calm the mind and the need to soothe and protect the liver. It also compensates for the limitations of the principal herb, which only relieves hangovers and provides little protection. This invention also constitutes another core innovation of its synergistic approach to hangover relief and liver protection, and its comprehensive multi-target conditioning. Acorus tatarinowii, with its aromatic and penetrating properties, guides the medicine to the brain, assisting the principal ingredient in clearing the mind and relieving drowsiness and lethargy after drinking. It also dispels dampness, harmonizes the stomach, calms the nerves, and alleviates nausea, irritability, and insomnia after drinking, achieving a dual effect of relieving hangovers and calming the mind. This overcomes the technical deficiency of existing products that only relieve hangovers without calming the mind. Its aromatic scent also enhances the refreshing taste of chewing gum. Vinegar-processed Bupleurum chinense soothes the liver, regulates qi, and clears damp-heat from the liver and gallbladder. Its guiding properties allow the medicine to precisely target the liver and gallbladder meridians, restoring their function and relieving hypochondriac pain and irritability after drinking. It also has liver-protecting, enzyme-lowering, and anti-liver-damage effects, specifically improving liver and gallbladder stagnation and damage caused by long-term drinking. Furthermore, its mild taste does not affect the overall flavor after being combined with other ingredients. The combination of these two ingredients allows this product to relieve acute intoxication while providing dual protection for the central nervous system and hepatobiliary system, achieving synergistic effects of acute relief and chronic protection, unlike the shortcomings of existing technologies that only address a single aspect.

[0047] 3. Using tangerine peel, poria cocos, and dried jujube as adjuvant herbs to assist the principal and assistant herbs in exerting their effects, this invention focuses on strengthening the spleen and supporting the body's resistance, resolving dampness and harmonizing the stomach, and harmonizing the properties of the herbs. This achieves the goal of eliminating pathogens while supporting the body's resistance, which is an important support for the invention's ability to gently regulate the body and make it suitable for long-term use. At the same time, it also takes into account the optimization of the taste of sugar-free chewing gum. Dried tangerine peel regulates qi, strengthens the spleen, harmonizes the stomach, and relieves nausea, improving qi stagnation in the spleen and stomach after drinking. It also neutralizes the cold nature of the principal herb, harmonizing the overall medicinal properties and preventing further damage to the spleen and stomach. Its aroma enhances the flavor of chewing gum. Poria cocos strengthens the spleen, aids digestion, and promotes diuresis, working synergistically with jujubes to enhance spleen-strengthening and tonifying effects, promoting the elimination of dampness from alcohol, repairing spleen and stomach function, and helping to reduce liver damage. Its delicate texture improves the smoothness of chewing gum. Dried jujubes replenish qi and nourish the middle jiao, are sweet and mild, protecting the qi and blood damaged by alcohol toxicity, moderating the medicinal properties, calming the mind and soothing the nerves, improving post-drinking weakness, irritability, and insomnia. Its sweet taste naturally neutralizes the slight bitterness of other herbs, eliminating the need for artificial sweeteners and achieving "natural flavoring + synergistic medicinal effects," perfectly suited to the taste requirements of sugar-free chewing gum. The three elements work together to build a stable system that strengthens the spleen and stomach, eliminates dampness and supports the body's vital energy, and harmonizes the properties of the medicines. This not only provides a foundation for the efficacy of the principal and assistant medicines, but also makes this product suitable for people with various constitutions. It is safe and gentle for long-term use, thus solving the shortcomings of existing products that have unbalanced medicinal properties and are not suitable for long-term conditioning.

[0048] 4. Using rose petals as the guiding ingredient to assist the overall formula, focusing on gently soothing the liver, regulating emotions, and harmonizing the various herbs, is an important improvement in this invention to achieve liver soothing without depleting qi and to provide a gentler conditioning effect. It is also the core support for the chewing gum's taste and breath-freshening effect. Rose petals are sweet, slightly bitter, and warm in nature. They soothe the liver, relieve depression, regulate qi, and harmonize the middle jiao. They can assist vinegar-processed Bupleurum in enhancing the liver-soothing effect, improving liver qi stagnation and liver meridian obstruction, without the drawbacks of being pungent and dispersing and depleting qi, thus avoiding damage to the spleen and stomach's vital energy. This solves the problem of existing liver-soothing herbs easily depleting qi and damaging vital energy. At the same time, they can assist tangerine peel and Poria in regulating the stomach and intestines, soothing emotions, and improving emotional fluctuations after drinking alcohol. They can also guide the medicinal effects to the liver and spleen meridians, harmonizing the properties of the entire formula, making the overall compatibility more balanced, further improving the compatibility logic of regulating the liver and spleen, eliminating pathogens and supporting vital energy, and enhancing the mildness and wide applicability of this product. Its natural fragrance can give chewing gum a refreshing taste, while also achieving the additional effect of "fresh breath," which is different from existing single-purpose oral preparations for relieving hangovers.

[0049] The combination of these herbs, with its rigorous formulation and clear synergistic effects, offers core innovative advantages that are embodied in the following five points, significantly distinguishing it from existing hangover remedies:

[0050] 1. Triple hangover relief and multi-target health care synergistic innovation: The principal drug constructs a triple hangover relief mechanism of "inhibiting alcohol absorption, accelerating alcohol metabolism, and promoting the excretion of alcohol-induced dampness", which can quickly relieve acute drunkenness; the assistant, adjuvant and guiding drugs simultaneously achieve liver protection, stomach protection, liver soothing, calming the mind and strengthening the spleen, covering five major targets: detoxifying alcohol, eliminating dampness and turbidity, strengthening the spleen and stomach, soothing liver qi, and calming the mind. It simultaneously improves the multi-system damage caused by drinking, fundamentally solving the technical defects of existing products that only relieve hangovers but do not provide health care or one-sided conditioning.

[0051] 2. Synergistic Innovation in Targeted Delivery: This invention innovatively uses four guiding herbs—dried kudzu root, vinegar-processed bupleurum root, acorus tatarinowii rhizome, and rose petals—with clear division of labor and precise targeting. These herbs guide the medicinal effects to the spleen and stomach, liver and gallbladder, central nervous system, and liver and spleen meridians, respectively. Combined with the mucosal absorption characteristics of sugar-free chewing gum, this achieves precise delivery of the medicinal effects, significantly improving efficacy and reducing drug dissipation. It solves the problems of weak targeting, scattered effects, and poor efficacy of existing hangover remedies.

[0052] 3. Harmonious and Synergistic Innovation of Medicinal Properties: By using tangerine peel and jujube to moderate the cold nature of the principal ingredient, and rose petals to moderate the pungent and dispersing nature of bupleurum, the entire formula strictly adheres to the principles of clearing heat without harming yang, promoting diuresis without harming yin, strengthening the spleen without being greasy, and eliminating pathogens while supporting the body's resistance. The formula is mild in nature, has a wide range of applications, and can be used for a long time, solving the shortcomings of existing products such as unbalanced medicinal properties, insufficient safety, and unsuitability for long-term conditioning. At the same time, it is flavored with natural ingredients, which is compatible with the taste of sugar-free chewing gum, eliminating the need for artificial sweeteners, making it healthier and more easily accepted by the public.

[0053] 4. Integrated approach to regulating the liver and spleen, and strengthening the body's resistance while eliminating pathogens: This invention constructs a comprehensive conditioning system that simultaneously relieves hangovers, protects the stomach, soothes the liver and calms the mind, and freshens the breath, while also addressing both the elimination of pathogens and the strengthening of the body's resistance. It not only quickly improves the discomfort of acute drunkenness and hangovers, but also continuously addresses the liver and stomach damage, meridian stagnation, and restlessness caused by long-term drinking. It fills the gap in existing technologies that lack systematic conditioning and struggle to address both acute relief and chronic protection, demonstrating outstanding innovation and practicality.

[0054] 5. Deep Adaptation and Innovation of Dosage Form, Efficacy, and Scenarios: The sugar-free chewing gum dosage form is selected to achieve a deep integration of "dosage form + efficacy + scenario". It not only solves the pain points of the existing dosage forms being inconvenient to use at drinking parties and having poor concealment, but also improves the speed of onset of action through mucosal absorption. At the same time, it achieves the dual effects of "sobering up and freshening breath", filling the gap in the existing technology for oral hangover relief dosage forms that are "adapted to drinking parties, have dual effects, and have excellent taste", and has outstanding innovation and practicality.

[0055] In summary, the sugar-free chewing gum is scientifically formulated with precise proportions and a clear distinction between principal, assistant, and adjuvant ingredients. It adheres to traditional Chinese medicine theory while incorporating modern pharmacological research and the characteristics of the sugar-free chewing gum formulation. It fully embodies the advantages of food and medicine homology, safety and gentleness, long-term adjustability, prevention and regulation combined, and scenario adaptability. It balances efficacy, safety, portability, and taste. Its core mechanism and innovations are significantly different from existing technologies. It can provide a gentle, efficient, comprehensive, and convenient internal conditioning solution for drinkers and can be combined with external acupoint gel ointments to form a systemic prevention and treatment preparation. It has significant patent protection value and promising industrial application prospects.

[0056] Herb replacement plan

[0057] The three medicinal herbs in the sugar-free chewing gum can be replaced in equal amounts without affecting the efficacy or the taste and chewing characteristics of the sugar-free chewing gum: 0.5-1 part by weight of dried tangerine peel can be replaced with any one of Buddha's hand, Cyperus rotundus, or Aucklandia lappa (all of which are mild-smelling, qi-regulating, and spleen-strengthening medicinal and edible ingredients, and do not affect the taste); 0.5-1 part by weight of Poria cocos can be replaced with any one of Coix lacryma-jobi, Artemisia capillaris, Atractylodes macrocephala, Alisma plantago-aquatica, or Polyporus umbellatus (the texture is delicate, suitable for the chewing taste of chewing gum, and the medicinal properties are mild); 0.5-1 part by weight of dried jujube can be replaced with any one of licorice, ginseng, Codonopsis pilosula, or Astragalus membranaceus (all of which have a sweet and mild effect, can achieve natural flavoring, and are suitable for the taste requirements of sugar-free chewing gum).

[0058] Other oral formulations: The core of the oral formulation of this invention is preferably sugar-free chewing gum. Simultaneously, based on actual application needs, while retaining the core formula and efficacy, it can be formulated into breath-freshening lozenges, throat-soothing lozenges, chewable lozenges, granules, capsules, oral liquids, syrups, and various ready-to-drink health beverages. The sugar-free chewing gum can be further processed using different methods such as gum-based or compressed forms. Various ready-to-drink health beverages include plant-based beverages, herbal beverages, functional beverages, oral liquid beverages, bottled ready-to-drink teas, canned beverages, and other pharmaceutically or food-grade oral formulations, adapting to different usage scenarios, consumption habits, and population needs, further enhancing the convenience and industrial application prospects of the formulation. All extended formulations inherit the dual effects of the core formula: hangover relief and breath freshening.

[0059] B. Topical gel ointments (poop ointments)

[0060] Gel ointment (paste ointment), as a preferred dosage form for external acupoint application, combines the advantages of high transdermal absorption efficiency, moderate adhesion, low skin irritation, and long-lasting sustained release of the drug, perfectly meeting the acupoint application needs of various types of alcohol-related harms. This is the core and most outstanding creative part of this invention, and also the key technological breakthrough that distinguishes it from all existing external hangover remedies, completely solving the industry pain points of existing external hangover remedies such as "illogical acupoint selection, inaccurate targeting, and limited effectiveness." In existing technologies, external hangover remedies generally suffer from fatal flaws such as single acupoint selection and lack of clear logic in acupoint selection. They fail to combine meridian theory with the pathogenesis characteristics of alcohol-related harms, and cannot achieve "treating both the symptoms and the root cause, and addressing both acute and chronic conditions." Furthermore, those skilled in the art have long been limited by the traditional thinking of "single acupoint hangover relief" and have not realized the decisive influence of acupoint selection logic on the hangover relief effect.

[0061] This invention breaks through the above-mentioned technical bottlenecks. Based on the research on the etiology and pathogenesis of alcohol-related harm in traditional Chinese medicine, and combined with the core principles of meridian theory, it creatively achieves the technical breakthrough of "precise acupoint positioning + synergistic application of multiple classic acupoint combinations + precise matching of syndrome type, ointment, and acupoints", thus constructing a three-dimensional external treatment system that covers all stages and syndrome types of alcohol consumption and treats both the exterior and interior.

[0062] I. The Etiology and Core Pathogenesis of the Harmful Effects of Alcohol Consumption in Traditional Chinese Medicine

[0063] Traditional Chinese medicine believes that alcohol is warm in nature, pungent, sweet, and bitter in taste, and toxic. It enters the heart, liver, lung, and stomach meridians. Its characteristics are pungent, hot, dry, and volatile, easily depleting qi and blood, damaging the spleen and stomach, disturbing the mind, and generating damp heat. Moderate drinking can promote blood circulation and warm the spleen and stomach, but excessive or long-term alcoholism will lead to alcohol poisoning and dampness, falling under the category of diseases caused by dietary indiscretion. Its pathogenesis is to first damage the spleen and stomach, then affect the liver, gallbladder, heart, kidneys, and blood vessels. The pathogenesis changes from excess to deficiency, and then from deficiency to excess, ultimately leading to organ deficiency and meridian obstruction, forming a complex syndrome of simultaneous exterior and interior disease and imbalance between the upper and lower parts of the body.

[0064] 1. Core etiology:

[0065] 1.1 Excessive drinking and long-term alcoholism cause alcohol toxins (damp-heat toxins) to directly invade the body, first damaging the superficial skin and spleen and stomach, and over time penetrating deep into the internal organs and meridians, forming a syndrome of both superficial and internal diseases.

[0066] 1.2 Triggering / Aggravating Factors:

[0067] 1.2.1. After drinking alcohol, the pores are loosened and the defensive qi is not consolidated, making it easy to be infected by external wind, cold and dampness. When external pathogens combine with alcohol poisoning, the damage is aggravated by the combination of external and internal pathogens.

[0068] 1.2.2 Individuals with weak spleen and stomach, liver and gallbladder imbalance, or yin deficiency with excessive fire have inherently weak organ functions and insufficient vital energy. Alcohol toxins can easily penetrate from the surface to the interior, leading to a prolonged and difficult-to-cure course of illness.

[0069] 2. Core Pathogenesis

[0070] 2.1 The overall pathogenesis is that alcohol poisoning (damp-heat) invades the body, first damaging the spleen and stomach, the superficial manifestations, causing qi stagnation and damp-heat steaming; over time, it depletes qi and damages yin, causing blood stasis and obstructing the collaterals, penetrating deep into the liver, kidneys and heart, resulting in deficiency of the internal organs, and ultimately forming a complex pathogenesis of simultaneous exterior and interior disease, mixed deficiency and excess, and imbalance between the upper and lower parts of the body.

[0071] 2.2 Staged Pathogenesis:

[0072] 2.2.1. Initial stage (mild / short-term drinking): Alcohol dampness impairs the spleen, invades the skin surface, impairs the spleen and stomach's function of transportation and transformation, and obstructs the flow of qi. It is mainly characterized by superficial excess, with both superficial and internal diseases, and no obvious deficiency of the internal organs.

[0073] 2.2.2. Mid-term (long-term excessive): Dampness transforms into heat, and damp heat steams and affects the liver and gallbladder from the spleen and stomach. The external evil is not resolved and the internal heat gradually increases. Both the exterior and interior are full, and the original deficiency is revealed. This is the beginning of a mixture of deficiency and excess.

[0074] 2.2.3. Late stage (long-term alcoholism): The toxicity of alcohol has been lingering for a long time, affecting the internal organs and collaterals, depleting qi and yin, damaging the liver and kidneys, generating blood stasis, and damaging the liver, spleen, kidneys and heart. It is a case of deficiency in the root and excess in the branch, with both the exterior and interior being affected. It is a severe case of mixed deficiency and excess, which can lead to critical conditions such as masses, ascites, stroke, and collapse.

[0075] II. Core Acupoint Selection Principles and Acupoint Efficacy System for the Harmful Effects of Alcohol Consumption

[0076] This acupoint combination is based on the principle of exterior-interior pairing, strictly adhering to the principle of combining "specific functional acupoints with meridian-based acupoints." It addresses the pathogenesis of alcohol-related harm as "progressing from the exterior to the interior, and causing simultaneous exterior and interior symptoms," constructing a unique acupoint efficacy system that "treats the exterior to dispel pathogens, treats the interior to strengthen the body, and treats both exterior and interior simultaneously." It also considers "relieving symptoms by alleviating exterior pathogens, treating the root cause by repairing the internal organs, and clearing the meridians to resolve stagnation." The principles for selecting each core acupoint and their efficacy are as follows. Combined with sugar-free chewing gum, it achieves the dual effect of "rapid relief + long-term maintenance":

[0077] 1. Core principles of acupoint selection

[0078] 1.1. The method of combining exterior and interior acupoints: This is the core principle of the combination method, which is to select acupoints on the body surface to detoxify alcohol, dispel external pathogens, and dredge the meridians, and select acupoints of the internal organs / specific functional acupoints to regulate the internal organs, strengthen the body's resistance, and consolidate the foundation, so as to achieve "detoxification of external pathogens, harmony of internal qi, and simultaneous treatment of exterior and interior", which is in line with the core pathogenesis of alcohol-related diseases that affect both the exterior and interior.

[0079] 1.2 Combination of specific functional acupoints and meridian acupoints: Targeting the core pathogenesis of kidney yin deficiency, heart fire rising, and blood stasis caused by alcohol poisoning, specific functional acupoints are selected for targeted treatment: At the same time, acupoints are selected along the liver, spleen, stomach, heart, and kidney meridians to dredge the meridians and blood, and enhance the effect of the combination of exterior and interior acupoints.

[0080] 1.3 The method of multiple acupoint combinations takes into account the balance: the combination of Yu and Mu acupoints regulates the deficiency and excess of the internal organs, the combination of distant and near acupoints dredges the meridians and blood, the combination of upper and lower acupoints harmonizes Yin and Yang and connects the heart and kidneys, complementing the combination of exterior and interior acupoints to build a comprehensive acupoint conditioning system.

[0081] 2. Core Acupoint Efficacy System

[0082] This invention precisely selects acupoints that correspond to the pathogenesis of alcohol-related damage, forming a comprehensive functional system covering the heart and brain, liver and spleen, stomach, kidneys, qi and blood, and meridians. Each acupoint not only precisely corresponds to different stages of alcohol damage but also synergistically forms a complete coverage of the "heart and brain - liver and stomach - qi and blood - meridians" domain, specifically including:

[0083] 2.1. Specific acupoints for nourishing the kidneys and warming yang: Taixi (the original acupoint of the kidney meridian and the root acupoint of the viscera), nourishes yin and benefits the kidneys, strengthens the source of the lower jiao, and treats the root cause of liver and kidney yin deficiency;

[0084] 2.2 Strengthening the foundation and nourishing the source: Guanyuan (small intestine front point, Ren meridian, the root point of the viscera), warms and tonifies the original qi, nourishes the kidneys and strengthens the foundation, and treats the deficiency of the root of the body's vital energy caused by alcohol poisoning;

[0085] 2.3 Guiding Fire Back to its Source Point: Yongquan (Kidney Meridian Well Point, Body Surface Connecting Point), guides deficient fire downwards, connects the heart and kidneys, and relieves the superficial heat symptoms of deficient fire flaring upwards;

[0086] 2.4 Nourishing Yin and Activating Blood Circulation Acupoints: Sanyinjiao (the meeting point of the liver, spleen and kidney meridians, a pivotal point between the interior and exterior) and Xuehai (a point on the spleen meridian, a connecting point on the body surface). Selecting acupoints along the meridians nourishes Yin and blood, and harmonizes Qi and blood. This not only relieves the stagnation of blood vessels on the surface, but also replenishes the Yin and blood of the liver and spleen, the foundation of the internal organs.

[0087] 2.5 Clearing Heart Fire and Reducing Internal Fire along Meridians: Daling (the original point of the pericardium meridian, the root point of the viscera), Laogong (the spring point of the pericardium meridian, the connecting point on the body surface), along the pericardium meridian, to clear the root of heart fire and relieve restlessness.

[0088] 2.6 Core acupoints for calming the mind and stabilizing the will: Shenmen (original acupoint of the Heart Meridian, the original acupoint of the Zang-Fu organ), Neiguan (acupoint of the Pericardium Meridian, one of the eight extraordinary meridians, and a Luo-connecting acupoint on the body surface), the Heart Meridian and the Pericardium Meridian are paired acupoints to calm the mind and stabilize the body, relieve chest tightness, regulate Qi and relieve exterior symptoms;

[0089] 2.7 Acupoints for facilitating communication between the heart and kidneys: Baihui (Du Meridian, meeting point of all Yang meridians, Yang acupoint on the body surface), Yongquan (Kidney Meridian Well Point, Yin acupoint on the body surface), upper and lower + interior and exterior acupoints are combined to promote the ascending of clear and descending of turbid, guide fire back to its origin, harmonize Yin and Yang, and facilitate communication between the heart and kidneys;

[0090] 2.8 Meridian points for clearing heat and promoting diuresis: Yanglingquan (He-Sea point of Gallbladder Meridian, the original point of Zang-Fu organ) and Taichong (Yuan-Source point of Liver Meridian, the pivot point of exterior and interior), are paired points of the exterior and interior of the Liver and Gallbladder Meridians, which clear and drain the root of the excess fire in the Liver and Gallbladder and promote diuresis on the surface of damp heat.

[0091] 2.9 Acupoints for regulating the liver and spleen: Zhangmen (spleen front point, visceral meeting point, visceral root point), which regulates the liver and spleen, resolves dampness and harmonizes the middle jiao, addresses the root cause of liver and spleen imbalance, and relieves the surface obstruction of qi.

[0092] 2.10 Key acupoints for strengthening the spleen and resolving dampness: Zusanli (He-Sea point of the Stomach Meridian, pivotal point between exterior and interior) and Yinlingquan (He-Sea point of the Spleen Meridian, original point of the Zang-Fu organ). These are paired acupoints of the Spleen and Stomach Meridians, which strengthen the spleen and stomach, consolidate the foundation, promote diuresis, eliminate dampness, and relieve exterior symptoms. They are the core acupoints for resolving dampness caused by alcohol and stagnation in the spleen.

[0093] 2.11 Acupoints for regulating Qi and relieving bloating: Tianshu (large intestine front point, the root point of the viscera) and Qihai (Ren meridian point, the connecting point on the body surface). These acupoints are paired to regulate Qi, harmonize the middle Jiao, strengthen the foundation, relieve bloating, eliminate fullness, and release the exterior, thus alleviating the exterior symptoms of epigastric and abdominal distension.

[0094] 2.12 Specific acupoints for unblocking blood stasis: Xuehai, Sanyinjiao (external connecting point), Taichong (internal-external pivot point), these acupoints are combined to promote blood circulation, remove blood stasis, unblock the meridians, relieve numbness of limbs and obstruction of blood vessels, and replenish the deficiency of yin and blood.

[0095] III. Common TCM syndrome differentiation of alcohol-related harms and corresponding external acupoint gel / ointment applications (Babu plaster)

[0096] This invention follows the principles of "differentiated application of plasters, integration of medicine and acupoints, treatment of both symptoms and root causes, and simultaneous treatment of exterior and interior," precisely adapting gel ointments (Babu plasters) to the five core syndrome types caused by alcohol consumption. Each syndrome type's ointment adheres to the principles of "ingredients matching the pathogenesis, matrix conforming to acupoints, and process ensuring transdermal absorption." Raw materials are selected from medicinal and edible sources or commonly used Chinese herbs. The matrix uses a hydrophilic composite formula (carbomer, glycerin, propylene glycol, etc.), balancing the dissolution and transdermal absorption of effective ingredients of different polarities. The plaster has moderate adhesion, does not pull on hair, and has good skin compatibility. All syndrome types are based on the principle of exterior-interior acupoint matching, combining specific functional acupoints and meridian-based acupoints to achieve "treatment of the exterior, treatment of the interior, and simultaneous treatment of both exterior and interior," achieving the triple goals of "immediate relief of discomfort, long-term repair of internal organs, and unblocking of meridian obstructions." Furthermore, the herbal formula is specifically designed for the acupoint combination method and specific acupoints of this invention. The selection of guiding herbs and the combination of the four properties and five flavors of medicinal materials are precisely matched with the meridian attributes and efficacy characteristics of each acupoint, achieving a synergistic effect of "medicine-acupoint-acupoint combination method," breaking the limitation of existing external patches where "medicine and acupoint are disconnected." When combined with oral sugar-free chewing gum, it forms a synergistic prevention and treatment effect of "rapid absorption through the oral mucosa to relieve acute symptoms and long-term transdermal conditioning through acupoints to strengthen the root cause," further amplifying the innovative advantages of the dosage form combination. The specific syndrome differentiation and ointment application are as follows:

[0097] 1. Spleen deficiency with dampness syndrome (early stage / mild symptoms of alcohol consumption, corresponding to the pathogenesis of alcohol-induced dampness trapping the spleen, external invasion of pathogens, and simultaneous internal and external disease)

[0098] 1.1 Symptoms include epigastric fullness and discomfort, sticky mouth, poor appetite, heaviness in the limbs, loose and sticky stools, white and greasy tongue coating, and a soft and slow pulse, accompanied by heaviness in the limbs and general soreness and heaviness. It is mostly caused by excessive drinking in a short period of time, which leads to dampness in the spleen and invades the skin surface, resulting in dysfunction of the spleen and stomach and stagnation of qi. It is the most common syndrome in the early stage of drinking. It is mainly characterized by excess in the superficial aspects, with both superficial and internal diseases, and no obvious deficiency of the internal organs.

[0099] 1.2 Targeted Acupoints

[0100] Based on the principle of exterior-interior acupoint selection, this method combines specific functional acupoints with meridian-based acupoints. It selects acupoints related to strengthening the spleen, resolving dampness, regulating qi, and relieving bloating, along with superficial connecting points. It also incorporates the Shu-Mu acupoint selection method and the distal-proximal acupoint selection method. The main application areas are the chest, abdomen, lower back, and lower limbs. The plaster is pre-made in 4cm×4cm (chest / abdomen / lower back) and 3cm×3cm (lower limbs) sizes to fit the skin at the acupoints.

[0101] 1.2.1 Core acupoints (internal and external points): Zang-Fu point (Zhongwan, Zhangmen, Yinlingquan) + surface connecting points / internal and external pivot points (Zusanli, Tianshu, Qihai).

[0102] 1.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0103] 1.2.2.1 Treating the root cause: Zhongwan (stomach front point, meeting point of the viscera), Zhangmen (spleen front point, meeting point of the viscera), and Yinlingquan (spleen meridian He-Sea point) are the root points of the viscera and viscera. They strengthen the spleen and resolve dampness, regulate the liver and spleen, restore the digestive function of the spleen and stomach, and treat the root cause of dampness and alcohol in the spleen.

[0104] 1.2.2.2 Treating Exterior Pathogens: Zusanli (Stomach Meridian He-Sea Point, the pivot point between exterior and interior), Tianshu (Large Intestine Mu Point), and Qihai (Ren Meridian Exterior Connecting Point) are exterior connecting points, which promote diuresis and eliminate dampness, regulate qi and relieve bloating, and relieve abdominal distension and heaviness in the limbs caused by alcohol-induced dampness invading the skin and qi stagnation;

[0105] 1.2.2.3 Synergistic Effect of Exterior and Interior: The combination of acupoints regulates the spleen, stomach, and intestines in a coordinated manner, which not only strengthens the spleen and stomach and consolidates the foundation, but also promotes diuresis, eliminates dampness and relieves exterior symptoms, quickly resolves alcohol-induced dampness, and prevents external pathogens from entering the interior and aggravating damage to the internal organs.

[0106] 1.3. Raw materials and weight ratios for corresponding gel ointments (patch ointments)

[0107] 1.3.1 Spleen-strengthening and dampness-resolving gel ointment, with the core functions of "strengthening the spleen and replenishing qi, drying dampness and resolving dampness, regulating qi and relieving bloating", takes into account both treating the internal and strengthening the body and treating the external and eliminating pathogens. The raw materials are mild in nature, have good transdermal properties, and are suitable for long-term application and conditioning.

[0108] 1.3.1.1 Weight ratio: Codonopsis pilosula 2-4 parts, Atractylodes macrocephala 2-4 parts, Poria cocos 1-2 parts, Dioscorea opposita 1-2 parts, Citrus reticulata 1-2 parts, Coix lacryma-jobi 1-2 parts, Mentha haplocalyx 0.1-0.5 parts.

[0109] 1.3.1.2 Matrix formulation (per 100g of ointment): Carbomer 940 6-7g, hydroxypropyl cellulose 4g, glycerin 22-24g, propylene glycol 12-14g, azone 1.5g, triethanolamine 2.5g, benzalkonium bromide 0.08g, distilled water to 100g (pH 6.5-7.0, hydrophilic matrix, non-greasy when applied, low skin irritation).

[0110] 1.4. Ointment Formulation Logic and Mechanism of Action

[0111] 1.4.1 Principal herbs: Codonopsis pilosula and Atractylodes macrocephala. The two herbs complement each other, invigorating the spleen and replenishing qi, drying dampness and resolving dampness, directly targeting the core pathogenesis of "dampness trapping the spleen due to alcohol". They are highly compatible with the "invigorating the spleen and resolving dampness" therapeutic effects of the viscera and acupoints such as Zhongwan and Yinlingquan, thus treating the interior and strengthening the foundation.

[0112] 1.4.2 Assistant herbs: Poria cocos and Dioscorea opposita. Poria cocos promotes diuresis and eliminates dampness, strengthens the spleen and stomach, while Dioscorea opposita invigorates qi and nourishes yin, strengthens the spleen and stomach. They assist the principal herbs in strengthening the spleen and eliminating dampness. At the same time, they work together with acupoints on the body surface such as Zusanli to promote diuresis, eliminate dampness and relieve exterior symptoms, and alleviate heaviness in the limbs and loose stools.

[0113] 1.4.3 Adjuvant herbs: Tangerine peel and coix seed. Tangerine peel regulates qi and stomach, dries dampness and resolves phlegm, and promotes the elimination of qi stagnation in the spleen and stomach. It is compatible with acupoints on the body surface such as Tianshu and Qihai, so it can regulate qi, relieve bloating and release the exterior, and improve epigastric and abdominal fullness. Coix seed promotes diuresis and eliminates dampness, strengthens the spleen and stops diarrhea, and promotes the elimination of alcohol and dampness from the lower jiao, thus treating both the exterior and interior.

[0114] 1.4.4 Medicinal ingredient: Peppermint. The volatile oil extracted from peppermint is incorporated into the ointment. It 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 harmonizes the properties of the whole formula, relieves the slight stuffiness at the application site, and improves the application experience.

[0115] Synergistic Mechanism of Ointment + Acupoints (Combining Exterior and Interior Acupoints) + Sugar-Free Oral Gum: The sugar-free oral gum is rapidly absorbed through the oral mucosa, quickly relieving acute discomfort such as sticky mouth and abdominal distension after drinking, while also freshening breath; the hydrophilic base ointment adheres closely to the exterior and interior acupoints, allowing the active ingredients to quickly penetrate the skin through the acupoints to dispel alcohol-induced dampness and relieve heaviness in the limbs; at the same time, it is conducted through the meridians to the acupoints of the internal organs, strengthening the spleen and stomach, restoring their digestive function, and consolidating the foundation to prevent further complications; the three work together to achieve "rapid dissipation of exterior pathogens, harmony of interior qi, and simultaneous treatment of exterior and interior," blocking the entry of alcohol-induced dampness and pathogens into the interior, and achieving the initial conditioning goal of "treating the symptoms and preventing further complications, and consolidating the foundation and nourishing the source."

[0116] 2. Damp-heat accumulation syndrome (mid-stage of alcohol consumption, corresponding to the pathogenesis of dampness transforming into heat, both exterior and interior excess, and initial manifestation of underlying deficiency)

[0117] 2.1 Symptoms include bitter taste in the mouth, bad breath, abdominal distension and pain, nausea, sticky and foul-smelling stools, dark yellow urine, red eyes and hypochondriac pain, red tongue with yellow and greasy coating, and slippery and rapid pulse, accompanied by general fever and oily skin. It is mostly caused by long-term excessive drinking, which leads to dampness and heat in the body. The damp heat steams the spleen, stomach, liver and gallbladder. The external evil has not been resolved and the internal heat is gradually increasing. Both the exterior and interior are in excess. The initial manifestation is that the spleen and stomach are weak. It belongs to the beginning of a mixed deficiency and excess syndrome.

[0118] 2.2 Targeted Acupoints

[0119] Based on the principle of exterior-interior acupoint selection, this method combines specific functional acupoints with meridian-based acupoints. It selects acupoints related to the liver, gallbladder, spleen, and stomach organs (liver, gallbladder, spleen, and stomach) that clear heat and dampness, soothe the liver, and harmonize the stomach, along with surface connecting points. This is combined with upper and lower acupoint selection, Shu-Mu acupoint selection, and distal-proximal acupoint selection. The plaster is pre-made in 4cm×4cm (chest / abdomen / lower back) and 3cm×3cm (upper limb / lower limb) sizes, suitable for application to acupoints on the chest, abdomen, lower back, ribs, and lower limbs.

[0120] 2.2.1 Core acupoints (internal and external points): Zang-Fu organs' own points (Liver Shu, Qimen, Zhangmen, Yinlingquan) + body surface connecting points / internal and external pivot points (Taichong, Yanglingquan, Zusanli, Zhongwan).

[0121] 2.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0122] 2.2.2.1 Treating the interior and strengthening the foundation: Ganshu (liver back Shu point), Qimen (liver front point), and Zhangmen (spleen front point) are the original points of the liver, gallbladder, and spleen organs. They can soothe the liver and clear heat, regulate the liver and spleen, clear the root of damp heat in the liver, gallbladder, spleen, and stomach, and also take into account the initial manifestation of spleen and stomach qi deficiency.

[0123] 2.2.2.2 Treating the exterior and dispelling pathogens: Taichong (the original point of the Liver Meridian and the pivot point between the interior and exterior), Yanglingquan (the He-Sea point of the Gallbladder Meridian), and Zusanli (the He-Sea point of the Stomach Meridian) are the connecting points on the body surface. They clear away damp heat, dredge the meridians, and relieve the exterior symptoms of red eyes, hypochondriac pain, and general fever caused by damp heat. Zhongwan is the Mu point of the Stomach Meridian. It also takes care of the Spleen and Stomach, harmonizes the middle and resolves dampness, and relieves the exterior symptoms of abdominal distension and pain.

[0124] 2.2.2.3 Synergistic Treatment of Internal and External Factors: The liver, gallbladder, spleen and stomach meridians are regulated in a coordinated manner to clear the root of internal heat and expel dampness from the exterior. At the same time, the body's vital energy is taken into account to avoid excessive heat clearing that could damage the body's inherent weakness. This achieves the goals of "clearing heat and promoting diuresis, treating both internal and external factors, and supporting the body's vital energy while eliminating pathogens".

[0125] 2.3. Raw materials and weight ratios for corresponding gel ointments (patch ointments)

[0126] 2.3.1 The heat-clearing and dampness-resolving gel ointment takes "soothing the liver and clearing heat, promoting diuresis and detoxifying, and harmonizing the stomach and resolving dampness" as its core function, while also addressing internal damp-heat and external dampness, clearing heat without damaging the spleen and resolving dampness without depleting body fluids.

[0127] 2.3.1.1 Weight ratio: Bupleurum 1-3 parts, Scutellaria baicalensis 1-2 parts, Artemisia capillaris 1-2 parts, Hovenia dulcis 1-3 parts, Coix lacryma-jobi 1-2 parts, Mentha haplocalyx 0.1-0.5 parts.

[0128] 2.3.1.2 Matrix formulation (per 100g ointment): Carbomer 940 5-6g, hydroxypropyl cellulose 3.5g, glycerin 20-22g, propylene glycol 13-15g, azone 1.8g, triethanolamine 2g, benzalkonium bromide 0.07g, distilled water to make up to 100g (add appropriate amount of polyethylene glycol 400 to the matrix to improve the dissolution and transdermal efficiency of fat-soluble components such as saikosaponins and Artemisia capillaris volatile oil, and to facilitate rapid transdermal penetration through acupoints on the body surface).

[0129] 2.4. Ointment Formulation Logic and Mechanism of Action

[0130] 2.4.1 Principal herbs: Bupleurum and Scutellaria. Bupleurum soothes the liver and relieves depression, and regulates the Qi of the liver and gallbladder. Scutellaria clears heat and dries dampness, and drains fire and detoxifies. The two herbs directly target the core pathogenesis of "damp-heat steaming the liver, gallbladder, spleen and stomach". They are highly compatible with the "soothing the liver and clearing heat" effects of the acupoints such as Liver Shu and Qimen, which are the root of the internal organs, and treat the root of damp-heat.

[0131] 2.4.2 Assistant herbs: Artemisia capillaris and Hovenia dulcis. Artemisia capillaris clears damp-heat in the liver and gallbladder, relieves jaundice and detoxifies, making it an essential herb for damp-heat in the liver and gallbladder. Hovenia dulcis detoxifies alcohol and promotes urination, specifically relieving alcohol-induced dampness. The two herbs assist the principal herbs in enhancing the effects of clearing heat and resolving dampness. Together with acupoints on the body surface such as Taichong and Yanglingquan, they treat external damp-heat pathogens and quickly relieve symptoms such as red eyes, hypochondriac pain, and scanty yellow urine.

[0132] 2.4.3 Adjuvant herb: Coix seed, which promotes diuresis and eliminates dampness, strengthens the spleen and stomach, and takes into account both dampness elimination and spleen protection. It avoids excessive heat-clearing and dampness-drying of Bupleurum and Scutellaria baicalensis, which deplete the spleen and stomach's vital energy. At the same time, it promotes the elimination of damp heat from the lower abdomen. It works synergistically with Zusanli and Yinlingquan to harmonize the middle and eliminate dampness, and relieve abdominal distension and pain.

[0133] 2.4.4 Using peppermint volatile oil: it guides the medicine through the meridians and skin, clears the head and eyes, and promotes the penetration of the effective components of the medicines through the body surface acupoints (Taichong, Yanglingquan) to the internal organs' acupoints (Ganshu, Qimen), so as to realize the communication of Qi and blood between the liver and gallbladder meridians, quickly clear the damp heat in the body, and at the same time harmonize the cold nature of the whole formula to avoid the cold medicine properties from stimulating the acupoints and skin.

[0134] Synergistic Mechanism of Ointment + Acupoints (Exterior-Interior Acupoint Combination) + Sugar-Free Oral Gum: The sugar-free oral gum is rapidly absorbed through the oral mucosa, quickly relieving acute discomfort such as bitter taste, bad breath, and nausea after drinking alcohol, while also freshening breath and soothing the liver and stomach; the lipophilic matrix in the ointment dissolves fat-soluble components such as saikosaponin and Artemisia capillaris volatile oil, which quickly penetrate the skin through the acupoints on the body surface, clearing away damp-heat pathogens and relieving red eyes, hypochondriac pain, and general fever; the hydrophilic matrix dissolves water-soluble components such as Citrus aurantium polysaccharide and Coix seed polysaccharide, which are transmitted to the acupoints of the internal organs through the meridians, clearing away the root cause of damp-heat in the liver, gallbladder, spleen, and stomach, while also addressing the initial signs of spleen and stomach qi deficiency; the acupoints achieve full coverage of the liver, gallbladder, spleen, and stomach meridians through the exterior-interior acupoint combination method, and the synergistic effect of the Shu-Mu, upper and lower, and distal acupoint combination method strengthens the synergistic effect of the "medicine-acupoint-combination method", promoting the expulsion of damp-heat pathogens from the lower jiao, while nourishing the spleen and stomach's vital energy. The three working together achieve "rapid relief of external pathogens, clearing of internal heat, strengthening of the body's resistance and elimination of pathogens, and simultaneous treatment of both the exterior and interior." This not only quickly alleviates acute symptoms such as bitter taste in the mouth, red eyes, and abdominal distension and pain after drinking alcohol in the middle stage, but also prevents damp-heat pathogens from penetrating deeper into the internal organs and aggravating the damage. At the same time, it takes care of the spleen and stomach's vital energy and avoids excessive heat clearing that depletes the body's inherent weakness, thus achieving the conditioning goal of "clearing damp-heat, nourishing the internal organs, regulating the liver and spleen, and blocking the progression of the disease" in the middle stage.

[0135] 3. Liver damage due to alcohol poisoning (in the later stages of alcohol consumption, corresponding to the depletion of Qi and Yin, deficiency of the root and excess of the branch, and the pathogenesis of both exterior and interior diseases).

[0136] 3.1 Symptoms include: dull pain in the hypochondrium, dizziness and tinnitus, dry mouth and throat, five-center heat (heat in the palms, soles, and chest), red tongue with little coating, and wiry, thready, and rapid pulse, accompanied by dry eyes, blurred vision, and slight swelling of the limbs; it is mostly caused by long-term alcohol abuse, which depletes liver yin due to prolonged alcohol heat, resulting in malnourishment of the liver collaterals. The root cause is deficiency (liver and kidney yin deficiency, qi and blood deficiency), while the branch cause is excess (deficiency fire rising upward, collaterals malnourishment). It is a disease affecting both the exterior and interior, and also involves the heart, brain, and eyes.

[0137] 3.2 Targeted Acupoints

[0138] Based on the principle of exterior-interior acupoint pairing, this product combines specific functional acupoints with meridian-based acupoint selection. It selects acupoints that nourish the liver and kidneys, promote yin and blood circulation, and improve eyesight, along with surface acupoints on the head, face, and limbs. It also incorporates the Shu-Mu acupoint pairing method, the distal-proximal acupoint pairing method, and the upper-lower acupoint pairing method. The ointment is pre-made in special sizes: 2cm×2cm (eyes, surface acupoints), 4cm×4cm (lower back, visceral acupoints), and 3cm×3cm (lower limbs, interior-interior pivot acupoints). The ointment base for the eyes is thinner (0.3mm thick) to avoid pressure on the skin around the eyes. It is suitable for application to acupoints on the head, face, lower back, and lower limbs.

[0139] 3.2.1 Core acupoints (internal and external points): Zang-Fu organs' own points (Liver Shu, Kidney Shu, Taixi) + body surface connecting points / internal and external pivot points (Sanyinjiao, Xuehai, Guangming, and various points around the eyes: Taiyang, Jingming, Zanzhu, Sizhukong).

[0140] 3.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0141] 3.2.2.1 Treating the interior and strengthening the foundation: Liver Shu (Liver Back Shu Point), Kidney Shu (Kidney Back Shu Point), and Taixi (Kidney Meridian Source Point, Specific Point for Nourishing the Kidney and Warming Yang) are the root points of the liver and kidney organs. They nourish the liver and kidney, nourish yin and benefit the kidney, and cultivate the root of liver yin and kidney yin. They treat the deficiency of qi and yin caused by alcohol poisoning.

[0142] 3.2.2.2 Treating the exterior and relieving pathogenic factors: Sanyinjiao and Xuehai are meridian points that nourish yin and activate blood circulation (body surface connecting points), nourishing yin and blood, regulating qi and blood, and relieving the exterior symptoms of hypochondriac pain caused by malnourishment of the connecting points and poor qi and blood circulation; Guangming (Gallbladder meridian connecting point) and various points around the eyes are body surface connecting points of the head and face, clearing the meridians of the eyes and relieving the exterior symptoms of dry eyes and blurred vision caused by liver blood deficiency; Taichong is the pivot point of the liver meridian, soothing the liver and regulating qi, and relieving the exterior symptoms of dizziness and tinnitus.

[0143] 3.2.2.3 Synergistic Effect of Internal and External Factors: Simultaneous tonification of the liver and kidneys, and simultaneous regulation of qi and blood. It not only nourishes the root of liver yin and kidney yin, but also nourishes yin and blood and unblocks the meridians, achieving "strengthening the foundation and cultivating the source, nourishing yin and relieving external symptoms, and regulating liver and eyes simultaneously".

[0144] 3.3. Raw materials and weight ratios for corresponding gel ointments (patch ointments)

[0145] 3.3.1 The liver-nourishing and vision-improving gel ointment is based on the core functions of "nourishing liver yin, replenishing essence and blood, and clearing the liver and improving vision". It also takes into account the internal treatment of nourishing the liver and kidneys and the external treatment of nourishing yin and improving vision. The medicine is mild and gentle, clearing without harming the body's vital energy and nourishing without being greasy.

[0146] 3.3.1.1 Weight ratio: 1-3 parts wolfberry, 1-2 parts ophiopogon japonicus, 1-2 parts angelica sinensis, 1-2 parts salvia miltiorrhiza, 1-2 parts red peony root, 1-2 parts bupleurum chinense, and 0.1-0.5 parts peppermint.

[0147] 3.3.1.2 Matrix formulation (per 100g of ointment): For the eyes (surface acupoints): Carbomer 940 3-4g, hydroxypropyl cellulose 2g, glycerin 25-28g, propylene glycol 10-12g, azone 1g, triethanolamine 1.5g, benzalkonium bromide 0.05g, distilled water to 100g (ointment thickness 0.3mm, light texture, no pressure around the eyes, suitable for rapid transdermal absorption of acupoints around the eyes); For the waist / back / lower limbs (internal organs acupoints / internal and external pivot acupoints): Carbomer 940 6-7g, hydroxypropyl cellulose 4g, glycerin 22-24g, propylene glycol 12-14g, azone 1.5g, triethanolamine 2.5g, benzalkonium bromide 0.08g, distilled water to 100g (long-acting sustained release, suitable for strengthening the body's foundation and nourishing the vital energy at the internal organs acupoints).

[0148] 3.4 Ointment Formulation Logic and Mechanism of Action

[0149] 3.4.1 Principal herbs: Goji berries and Ophiopogon japonicus. Goji berries nourish the liver and kidneys, replenish essence and blood, while Ophiopogon japonicus nourishes yin, generates fluids, calms the mind and soothes the nerves. The two herbs work together to directly target the core pathogenesis of "alcohol toxicity depleting qi and yin," and are highly compatible with the "yin-nourishing and blood-nourishing" effects of the acupoints such as Liver Shu, Kidney Shu, and Heart Shu, thus treating the interior, strengthening the foundation, and nourishing qi and yin.

[0150] 3.4.2 Assistant herbs: Angelica sinensis and Salvia miltiorrhiza. Angelica sinensis nourishes blood, invigorates blood circulation, regulates menstruation and relieves pain. Salvia miltiorrhiza invigorates blood circulation, removes blood stasis, and unblocks meridians. The two herbs assist the principal herbs, which not only enhance the effects of nourishing yin and blood, but also dissipate blood stasis and unblock meridians. Together with acupoints on the body surface such as Sanyinjiao and Xuehai, they treat the exterior, dissipate blood stasis, and relieve numbness of limbs and dull complexion.

[0151] 3.4.3 Adjuvant herbs: Red peony root and Bupleurum root. Red peony root clears heat, cools blood, disperses blood stasis, and relieves pain, assisting Salvia miltiorrhiza in enhancing the effect of promoting blood circulation and removing blood stasis, while clearing residual damp heat; Bupleurum root soothes the liver and regulates qi, and promotes the flow of qi, avoiding blood stasis from obstructing the flow of qi, while guiding the medicinal effect to the liver, spleen, and kidney meridians, taking into account both soothing the liver and protecting the spleen, and avoiding qi stagnation caused by excessive yin nourishment.

[0152] 3.4.4 Using peppermint volatile oil: It guides the medicine through the skin and meridians, clears the head and eyes, and promotes the penetration of the effective ingredients of the medicine through the body surface acupoints (Sanyinjiao, Baihui) to the internal organs acupoints (Ganshu, Shenshu), so as to realize the communication of Qi and blood between the liver, kidney and heart meridians. At the same time, it harmonizes the properties of the whole medicine, relieves the slight dryness at the application site, and improves the long-term application experience.

[0153] Synergistic mechanism of ointment + acupoints (internal and external acupoints) + oral sugar-free chewing gum: The oral sugar-free chewing gum is quickly and continuously absorbed through the oral mucosa. Vinegar-processed Bupleurum and Rose Flower soothe the liver and regulate Qi to relieve liver stagnation. Jujube, Ophiopogon japonicus and other ingredients gently nourish the liver and kidneys and replenish Qi and blood, quickly relieving symptoms of Yin deficiency and internal heat such as dry mouth and throat, dizziness, tinnitus, and five-center heat. At the same time, it freshens breath, strengthens the spleen and stomach, avoids liver Yin deficiency from affecting the spleen and stomach, and prevents the spleen and stomach from failing to function properly and aggravating the body's weakness. It harmonizes the liver and spleen from the inside, nourishes Qi and Yin, and blocks alcohol toxins from further depleting the Yin fluids of the internal organs. The water-soluble matrix in the ointment dissolves yin-nourishing and essence-replenishing components such as wolfberry polysaccharide and ophiopogon polysaccharide, which are transmitted through the meridians to the visceral acupoints such as liver shu, kidney shu, and taixi, directly targeting the root cause of liver and kidney yin deficiency, replenishing the liver and kidney yin depleted by prolonged alcohol consumption and heat, repairing the damaged liver and kidney functions, and restoring the nourishing power of the liver meridian. The fat-soluble matrix dissolves blood-nourishing and blood-activating components such as angelica, salvia miltiorrhiza, and red peony root, which penetrate through the skin through acupoints such as sanyinjiao, xuehai, guangming, and acupoints around the eyes, clearing away deficiency fire, unblocking the meridians, nourishing blood and improving eyesight, and quickly relieving symptoms such as hypochondriac pain, dry eyes, and blurred vision, while also addressing the superficial symptoms of malnourishment of the meridians and stagnation of the eye meridians. Acupoints work synergistically by combining the exterior-interior acupoint pairing method with the Yu-Mu, distal-proximal, and upper-lower acupoint pairing methods to achieve comprehensive conditioning of "nourishing the liver and kidneys, replenishing essence and blood, clearing the liver and improving eyesight, and unblocking the meridians and nourishing the blood vessels". It takes into account both the root deficiency of liver and kidney yin deficiency and qi and blood deficiency and the manifestation of deficiency fire rising and meridian malnourishment, so that yin is nourished without being greasy, heat is cleared without harming the body's vital energy, and blood is nourished without stagnation.

[0154] The three working together achieve "strengthening the foundation and nourishing the source, nourishing yin and improving eyesight, treating both the exterior and interior, and addressing both urgent and mild symptoms." This not only quickly relieves chronic discomforts such as dry eyes, dizziness, and hypochondriac pain caused by alcohol-induced liver damage (liver yin deficiency type), but also nourishes the depleted liver and kidney yin from the root, repairs damage to the liver and kidneys, clears internal heat, and unblocks the meridians throughout the body, preventing the condition from progressing to symptoms such as decreased vision, liver meridian obstruction, and aggravated organ deficiency. This achieves the later-stage conditioning goal of "nourishing liver yin, tonifying the liver and kidneys, improving eyesight and unblocking the meridians, and preventing further progression." Simultaneously, the three components work synergistically to form a long-term maintenance system for alcohol-induced liver damage (liver yin deficiency type). The sugar-free chewing gum can be used as a daily maintenance agent; long-term chewing can sustainably nourish the liver and kidneys, harmonize the liver and spleen, replenish qi and blood, and gradually enhance the body's yin fluid reserves, resisting further alcohol-induced liver yin depletion. The external liver-nourishing and vision-improving gel ointment can be applied as needed according to the severity of symptoms, specifically clearing the eye and liver / kidney meridians, nourishing the liver and eyes. Combined with the meridian regulation effect of acupoints, it strengthens the yin-nourishing and vision-improving effects. These two components complement each other, forming a full-cycle prevention and treatment system for alcohol-induced liver damage (liver yin deficiency type) from three dimensions: "relieving yin deficiency and vision symptoms, repairing liver and kidney damage, and enhancing the body's yin fluid nourishing ability." This compensates for the insufficient effect of a single oral preparation in clearing the meridians and improving vision, and the limited nourishing effect of a single external preparation on the internal organs, further enhancing the clinical applicability and preventative effect of the combined preparation, and meeting the long-term conditioning needs of chronic alcohol-induced liver damage patients with long-term alcohol abuse and liver yin depletion.

[0155] 4. Alcohol-induced mental disturbance syndrome (acute / chronic alcohol consumption, corresponding to heart-kidney disharmony, phlegm-fire disturbing the heart, deficiency of the root and excess of the branch, and simultaneous internal and external disease pathogenesis)

[0156] 4.1 Syndrome Manifestations

[0157] 4.1.1 Acute attack (alcohol poisoning disturbs the mind, excessive heat disturbs the mind): irritability and talkativeness, flushed face and red eyes, insomnia, red tongue with yellow and greasy coating, slippery and rapid pulse, and in severe cases, delirium and coma. The exterior is mainly due to excess (excessive heart fire and phlegm-fire flaring upward), while the interior is mainly due to deficiency (insufficient heart yin). Both exterior and interior are affected.

[0158] 4.1.2 Chronic exacerbation (phlegm-fire disturbing the heart, restlessness, disharmony between the heart and kidneys): irritability, insomnia, forgetfulness, palpitations, excessive dreaming, agitation, difficulty concentrating, dizziness, and headache. The primary cause is deficiency (heart and kidney yin deficiency, qi and blood insufficiency), while the secondary cause is excess (internal generation of phlegm-fire, upward flaring of deficient fire). This syndrome encompasses the core symptoms of the heart, brain, and mental system, and is a typical manifestation of alcohol poisoning affecting the mind and spirit, disharmony between the heart and kidneys, and a combination of internal and external symptoms, and a mixture of deficiency and excess.

[0159] 4.2 Targeted Acupoints

[0160] Based on the principle of exterior-interior acupoint selection, this method combines specific functional acupoints with meridian-based acupoints. It selects acupoints related to the heart, kidneys, and pericardium (heart, kidneys, pericardium, and viscera), which clear heat and calm the mind, and promote communication between the heart and kidneys. It also incorporates superficial acupoints on the head, face, chest, and limbs, using both upper and lower acupoint selection methods and distal-proximal acupoint selection. The ointment is pre-made in 3cm x 3cm (head / upper limbs, superficial acupoints) and 4cm x 4cm (chest / sole of the foot, viscera-related acupoints / superficial yin acupoints). The head ointment has moderate viscosity to avoid pulling on the scalp and hair, while the foot ointment is slightly thicker and suitable for application to the Yongquan acupoint. It is also suitable for application to acupoints on the head, face, chest, upper limbs, and soles of the feet.

[0161] 4.2.1 Core acupoints (internal and external acupoints): Zang-Fu organ-specific acupoints (Shenmen, Daling) + external connecting points / external Yin-Yang points (Neiguan, Laogong, Baihui, Tanzhong, Fenglong, Yongquan).

[0162] 4.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0163] 4.2.2.1 Treating the root cause: Shenmen (the original point of the Heart Meridian) and Daling (the original point of the Pericardium Meridian) are the original points of the heart and pericardium organs. They calm the mind and soothe the nerves, clear the heart and reduce fire, and treat the root cause of heart yin deficiency and heart fire excess, while also addressing the deficiency of organs due to heart-kidney disharmony.

[0164] 4.2.2.2 Treating Exterior Symptoms and Eliminating Pathogenic Factors: Neiguan (pericardium meridian point) and Laogong (pericardium meridian spring point) are superficial connecting points on the upper limbs, which can relieve chest tightness, regulate qi, clear heart fire, and relieve irritability and palpitations; Baihui (meeting point of all yang meridians of the Du meridian) and Tanzhong (qi meeting point) are superficial connecting points on the head, face, and chest, which can promote the ascending of clear qi and descending of turbid qi, awaken the mind and open the orifices, and relieve dizziness, headache, and mental confusion; Fenglong is a connecting point on the stomach meridian, which can resolve phlegm and reduce fire, and relieve the exterior symptoms of internal phlegm and fire; Yongquan (kidney meridian well point, fire-guiding point) is a yin point on the sole of the foot, which can guide deficient fire downwards and relieve the exterior symptoms of deficient fire rising upwards.

[0165] 4.2.2.3 Synergistic Effect of Exterior and Interior: The heart and kidneys interact, and phlegm and fire are cleared together. It not only calms the mind and nourishes the heart yin, but also clears the heart fire, resolves phlegm, opens the orifices, and guides fire back to its source, thus achieving "calming the mind and consolidating the foundation, clearing heat and relieving exterior symptoms, and harmonizing the heart and kidneys".

[0166] 4.3 Raw materials and weight ratios for corresponding gel ointments (paste ointments)

[0167] The Qingxin Anshen type gel ointment is based on the core functions of "clearing heat and resolving phlegm, clearing the heart and reducing fire, refreshing the mind and calming the nerves, and harmonizing the heart and kidneys". It also takes into account the internal treatment of nourishing the heart and kidneys and the external treatment of clearing heat and resolving phlegm. It is suitable for acute and chronic alcohol poisoning and mental disturbance and heart and kidney disharmony.

[0168] 4.3.1 Weight ratio: 1-3 parts of Acorus tatarinowii, 1-2 parts of Ziziphus jujuba var. spinosa, 1-2 parts of Salvia miltiorrhiza, 1-2 parts of Ophiopogon japonicus, 0.5-1 part of Gardenia jasminoides, 0.1-0.5 parts of Mentha haplocalyx, and 0.5-1 part of Glycyrrhiza uralensis.

[0169] 4.3.2 Matrix Formulation (per 100g of ointment): Head / Chest / Upper Limb Specific (Surface Acupoints): Carbomer 940 5g, Hydroxypropyl Cellulose 3g, Glycerin 23-25g, Propylene Glycol 11-13g, Azone 1.2g, Triethanolamine 2g, Benzalkonium Bromide 0.06g, Distilled Water to 100g (Mild viscosity, does not pull hair, suitable for rapid transdermal penetration of surface acupoints). Foot Specific (Yongquan, Yin Acupoints): Carbomer 940 7g, Hydroxypropyl Cellulose 4g, Glycerin 20g, Propylene Glycol 15g, Azone 1.5g, Triethanolamine 3g, Benzalkonium Bromide 0.08g, Distilled Water to 100g (Thick texture, moderate viscosity, long-lasting and sustained release, suitable for Yin Huo Gui Yuan).

[0170] 4.4. Ointment Formulation Logic and Mechanism of Action

[0171] 4.4.1 Principal herbs: Acorus tatarinowii and Ziziphus jujuba var. spinosa. Acorus tatarinowii is aromatic and opens the orifices, awakens the mind and calms the nerves, and resolves dampness and detoxifies, directly targeting the core pathogenesis of "alcohol poisoning disturbing the mind". It guides the medicine into the brain and quickly relieves confusion and restlessness. Ziziphus jujuba var. spinosa nourishes the heart and liver, calms the mind and soothes the nerves, nourishes the heart yin, and repairs the heart yin that has been depleted by alcohol poisoning. It is highly compatible with the "calming the mind and soothing the nerves" effects of the acupoints Shenmen and Daling, which are the root of the internal organs, and treats the interior and strengthens the foundation. The two herbs work together to achieve the dual effects of "detoxification and awakening the mind + nourishing yin and calming the nerves", taking into account both the symptoms and the root deficiency.

[0172] 4.4.2 Assistant herbs: Danshen and Ophiopogon japonicus. Danshen invigorates blood circulation, removes blood stasis, clears the heart and relieves irritability, assists Acorus tatarinowii in detoxification, and at the same time unblocks the heart vessels and relieves headaches. Ophiopogon japonicus nourishes yin and generates fluids, clears the heart and relieves irritability, strengthens the effect of Ziziphus jujuba var. spinosa in nourishing heart yin, relieves bitter taste in the mouth and dry throat, and hot palms and soles (symptoms of qi and yin deficiency). It works synergistically with Neiguan, Laogong and other acupoints on the body surface to treat external pathogens and relieve irritability and headaches.

[0173] 4.4.3 Adjuvant herbs: Gardenia and licorice. Gardenia clears heat and detoxifies, cools the blood, and relieves the symptoms of alcohol poisoning and heat, preventing further disturbance of the mind by heat evil; Licorice invigorates qi and nourishes the middle jiao, harmonizes the properties of the herbs, moderates the cold nature of gardenia, takes into account the root cause of qi and yin deficiency, prevents excessive clearing of the heart from depleting the body's vital energy, and at the same time protects the skin of acupoints and reduces irritation.

[0174] 4.4.4 Medicinal Agent: Peppermint volatile oil guides the medicine through the skin and meridians, clears the head and eyes, and promotes the penetration of the effective ingredients of the medicine through the body surface acupoints (Neiguan, Laogong, Baihui) to the internal organs' acupoints (Shenmen, Daling), realizing the communication of Qi and blood between the heart meridian and pericardium meridian, quickly clearing away alcohol toxins, calming the mind and relieving the slight dryness at the application site, and improving the application experience of sensitive areas such as the head, face and upper limbs.

[0175] Synergistic Mechanism of Ointment + Acupoints (External and Internal Acupoints) + Sugar-Free Oral Gum: The sugar-free oral gum is continuously absorbed through the oral mucosa. Ingredients such as Acorus tatarinowii and Bupleurum chinense quickly clear the heart and soothe the liver, calm the mind and soothe the nerves, relieving acute discomfort such as irritability, headache, and bitter taste after drinking alcohol. At the same time, it freshens breath, nourishes the heart yin, and replenishes the qi and blood depleted by alcohol toxins. The hydrophilic matrix in the ointment dissolves water-soluble components such as Ophiopogon japonicus polysaccharides and jujube seed saponins, which are transmitted to the corresponding acupoints of the internal organs through the meridians. This treatment nourishes the Yin of the heart, calms the mind and soothes the nerves, and repairs damage to the heart and brain. The lipid-soluble matrix dissolves lipid-soluble components such as tanshinone and volatile oils from Acorus tatarinowii, allowing them to penetrate the skin through acupoints on the body surface. This clears away alcohol toxicity and heat, refreshes the mind, and alleviates confusion and restlessness. Acupoints are selected using an exterior-interior combination method to achieve full coverage of the heart, brain, and Qi and blood. The synergistic effect of upper and lower, near and far acupoints enhances the combined effect of the "medicine-acupoint-acupoint combination method," balancing calming the mind and tonifying Qi, and preventing further penetration of alcohol toxicity. The three elements work together to achieve "rapid resolution of external pathogens, harmony of internal Qi, consideration of both deficiency and excess, and simultaneous treatment of both exterior and interior," quickly relieving immediate discomfort caused by alcohol toxicity disturbing the mind, nourishing the Yin of the heart, repairing damage to the heart and brain, and preventing the progression of the condition to alcohol toxicity obstructing the meridians. This achieves the conditioning goal of "calming the mind and detoxifying, nourishing and consolidating the foundation" in the transition from the mid-to-late stage.

[0176] 5. Alcohol-induced blood stasis syndrome (in the later stages of alcohol consumption, corresponding to a severe case of chronic illness affecting the collaterals, characterized by deficiency of the root and excess of the branch, and simultaneous involvement of both the exterior and interior).

[0177] 5.1 Symptoms include a sallow complexion, cyanosis of the lips and nails, masses under the ribs, numbness and tingling in the limbs, a dark purple tongue with ecchymosis, and a choppy pulse, accompanied by stiff neck and shoulders, difficulty in flexion and extension of the limbs, and fatigue. It is mostly caused by long-term alcohol abuse, which leads to the obstruction of the collaterals by alcohol and dampness, resulting in poor circulation of qi and blood, internal generation of blood stasis, and deficiency of the root cause (deficiency of yin and blood in the liver, spleen and kidneys, and insufficiency of vital qi), with excess in the manifestation (blood stasis obstructing the collaterals and meridian blockage) as the secondary cause. It is a severe case with both exterior and interior diseases, with blood stasis as the manifestation and deficiency of the internal organs as the root cause, affecting the liver, gallbladder, limbs, and blood vessels.

[0178] 5.2 Targeted Acupoints

[0179] Based on the principle of exterior-interior acupoint selection, this method combines specific functional acupoints with meridian-based acupoints. It selects acupoints related to the liver, spleen, and kidneys (liver, spleen, kidneys) for unblocking meridians, removing blood stasis, nourishing yin and promoting blood circulation, and strengthening the body's foundation. These are combined with superficial acupoints on the neck, shoulders, and limbs, as well as Ashi points. The plaster is pre-made in 4cm×4cm (neck, shoulders, back, visceral acupoints / superficial acupoints), 3cm×3cm (upper limbs, lower limbs, exterior-interior pivotal acupoints), and irregularly shaped plasters (Ashi points, superficial pain points). The main application areas are the neck, shoulders, back, limbs, and ribs. The plaster has slightly strong adhesion (peeling force 0.2-0.3 N / cm) and is suitable for use on active areas and Ashi points.

[0180] 5.2.1 Core acupoints (internal and external points): Zang-Fu root points / strengthening and nourishing points (Guanyuan, Zusanli, Zhangmen) + body surface connecting points / internal and external pivot points / Ashi points (Xuehai, Sanyinjiao, Taichong, Dazhui, Fengchi, Tianzhu, Jianjing, Ashi points, Houxi, Shenmai, Xuanzhong).

[0181] 5.2.2 Analysis of Acupoint Functions (Treating Both Exterior and Interior):

[0182] 5.2.2.1 Treating the interior and strengthening the foundation: Guanyuan (strengthening the foundation and nourishing the original qi), Zusanli (the He-Sea point of the Stomach Meridian), and Zhangmen (the Mu point of the Spleen) are the original points of the liver, spleen, and stomach. They warm and replenish the original qi, strengthen the spleen and stomach, soothe the liver and strengthen the spleen, nourish the foundation of both prenatal and postnatal qi, and treat the deficiency of vital qi and the deficiency of yin and blood caused by long-term consumption of alcohol poisoning.

[0183] 5.2.2.2 Treating the exterior and dispelling pathogens: Xuehai, Sanyinjiao, and Taichong are specific acupoints for clearing the meridians and removing blood stasis, plus acupoints for nourishing yin and activating blood circulation (exterior connecting points / interterior-interior pivot points), to activate blood circulation, remove blood stasis, clear the meridians, and relieve the exterior symptoms of blood stasis obstructing the meridians and numbness of the limbs; Dazhui, Fengchi, Tianzhu, Jianjing, and Ashi points are exterior connecting points / pain points of the neck and shoulders, to clear the Qi and blood of the Du meridian, Bladder meridian, and Gallbladder meridian, to loosen local muscle knots, remove blood stasis and relieve pain, and relieve the exterior symptoms of stiffness in the neck and shoulders and stabbing pain in the liver area; Houxi, Shenmai, and Xuanzhong are exterior connecting points of the limbs, to clear the meridians and relieve pain, strengthen muscles and bones, and relieve the exterior symptoms of difficulty in flexion and extension of the limbs;

[0184] 5.2.2.3 Synergistic Treatment of Internal and External Factors: It removes blood stasis without harming the body's vital energy and strengthens the body's vital energy without causing stagnation. It not only nourishes the body's vital energy and nourishes the blood, but also promotes blood circulation, removes blood stasis, and unblocks the meridians, thus achieving "strengthening the foundation, removing blood stasis and unblocking the meridians, and treating both the internal and external factors."

[0185] 5.3 Corresponding gel ointment (babu ointment) raw materials and weight ratio: Blood-activating and meridian-clearing gel ointment, with "activating blood and removing blood stasis, clearing meridians and relieving pain, relaxing muscles and relieving numbness, nourishing yin and supporting the body's resistance" as its core, takes into account treating the interior and replenishing the body's resistance, treating the exterior and removing blood stasis and clearing meridians, activating blood without depleting the body's resistance, and clearing meridians without being too dry or harsh, suitable for severe cases of alcohol poisoning and blood stasis with mixed deficiency and excess.

[0186] 5.3.1 Weight ratio: 2-4 parts of Salvia miltiorrhiza, 1-2 parts of Angelica sinensis, 1-2 parts of Ligusticum chuanxiong, 1-2 parts of Paeonia lactiflora, 1-2 parts of Lycium barbarum, 1-2 parts of Ophiopogon japonicus, and 0.1-0.5 parts of Mentha haplocalyx.

[0187] 5.3.2 Matrix formulation (per 100g of ointment): Carbomer 9407-8g, hydroxypropyl cellulose 5g, glycerin 20-22g, propylene glycol 14-16g, azone 2g, triethanolamine 3g, benzalkonium bromide 0.1g, distilled water to make up to 100g (Adding an appropriate amount of lanolin to the matrix improves the toughness and viscosity of the ointment, making it suitable for application to the neck, shoulders, limbs, and acupoints, preventing it from falling off, and achieving deep transdermal penetration, suitable for application to acupoints with meridian blockage).

[0188] 5.4 Ointment Formulation Logic and Mechanism of Action

[0189] 5.4.1 Principal herbs: Danshen and Danggui. Danshen invigorates blood circulation, removes blood stasis, clears the meridians, detoxifies, protects the liver and heart, directly targeting the core pathogenesis of "alcohol toxicity obstructing the meridians," making it an essential herb for invigorating blood circulation and removing blood stasis. Danggui nourishes and invigorates blood, regulates menstruation, and relieves pain. It not only invigorates blood circulation, removes blood stasis, and clears the meridians, but also nourishes qi and blood and repairs the qi and blood damaged by alcohol toxicity. It is highly compatible with the "invigorating blood circulation, removing blood stasis, nourishing blood, and clearing the meridians" effects of acupoints such as Ganshu, Qimen, and Xuehai, thus addressing both internal and external pathogenic factors.

[0190] 5.4.2 Assistant herbs: Chuanxiong and Chishao. Chuanxiong invigorates blood circulation, promotes qi circulation, dispels wind and relieves pain. It can "ascend to the head and eyes and descend to the blood sea," clearing the meridians throughout the body and relieving limb tingling and dizziness. Chishao clears heat, cools blood, disperses blood stasis and relieves pain. It assists Danshen and Danggui in enhancing the effects of invigorating blood circulation and removing blood stasis. At the same time, it clears away residual alcohol toxicity and heat evil. It works synergistically with Taichong, Sanyinjiao and other superficial acupoints to treat external pathogens and relieve numbness of limbs and rough skin.

[0191] 5.4.3 Adjuvant herbs: Goji berries and Ophiopogon japonicus. Goji berries nourish yin and benefit the kidneys, nourish the liver and improve eyesight, while Ophiopogon japonicus nourishes yin and generates fluids, clears the heart and relieves irritability. Together, they nourish the yin of the liver, kidneys and heart, replenish the yin fluids and qi and blood depleted by alcohol toxicity, take care of the underlying deficiency, avoid excessive blood stasis and depletion of yin and blood, and repair the liver, kidneys and heart damage caused by long-term alcohol toxicity. Together with the visceral acupoints such as Taixi and Shenmen, they enhance the effect of treating the interior and consolidating the foundation.

[0192] 5.4.4 Using peppermint volatile oil as a guide: Peppermint volatile oil guides the medicine through the skin and harmonizes its properties. It promotes the penetration of the effective components of the medicines through the acupoints on the body surface (Sanyinjiao, Xuehai, Taichong) to the acupoints of the internal organs (Taixi, Ganshu, Shenmen), so as to achieve the communication of Qi and blood between the liver, spleen, kidney and heart meridians. At the same time, it harmonizes the properties of the whole formula, relieves the slight dryness at the application site, and improves the long-term application experience.

[0193] Synergistic Mechanism of Ointment + Acupoints (Internal and External Acupoint Combination) + Sugar-Free Oral Gum: The sugar-free oral gum is continuously absorbed through the oral mucosa. Ingredients such as wolfberry, jujube, and ophiopogon japonicus gently nourish the liver, kidneys, heart, and spleen, replenish qi and blood, and relieve symptoms of yin deficiency such as dry mouth and throat, and fatigue. At the same time, it freshens breath, soothes the liver and stomach, and prevents further decline in spleen and stomach function caused by long-term alcohol abuse. The water-soluble matrix in the ointment dissolves yin-nourishing ingredients such as wolfberry polysaccharides and ophiopogon japonicus polysaccharides, which are transmitted to the acupoints of the internal organs through the meridians to nourish the depleted qi and yin and repair damaged internal organs. The fat-soluble matrix dissolves blood-activating ingredients such as angelica and salvia miltiorrhiza, which are transdermal through the acupoints on the body surface to dissipate blood stasis, dredge the meridians, and relieve numbness of limbs and rough skin. The acupoints are combined through multiple acupoint combinations to achieve a comprehensive conditioning of "nourishing yin, nourishing blood, activating blood, and calming the mind," taking into account both the deficiency and excess of the root cause. The three working together achieve "strengthening the foundation and nourishing the source, dispelling stagnation, treating both the exterior and interior, and addressing both urgent and mild symptoms." This not only alleviates the chronic discomfort after drinking in the later stages, but also repairs the damage to the internal organs caused by long-term alcohol abuse, clears the meridians and prevents the condition from progressing to critical conditions such as masses and bloating, thus achieving the conditioning goal of "nourishing and strengthening the foundation, promoting blood circulation and removing blood stasis, and preventing recurrence" in the later stages. Simultaneously, the three components work synergistically to form a long-term protective system. The sugar-free chewing gum can be used as a daily maintenance agent, and long-term chewing can continuously replenish qi and blood, nourish the internal organs, and enhance the body's resistance to alcohol poisoning. The external gel ointment can be applied as needed according to the severity of symptoms, specifically clearing meridian blockages and repairing local damage. It works in synergy with acupoints to enhance the conditioning effect. The two complement each other, forming a full-cycle prevention and treatment of alcohol poisoning and meridian blockage syndrome from the three dimensions of "relieving symptoms, repairing damage, and preventing recurrence". This makes up for the shortcomings of single dosage forms in achieving long-term maintenance and precise conditioning, further improving the clinical applicability and prevention and treatment effect of the combination preparation, and meeting the chronic conditioning needs of long-term alcohol abusers.

[0194] III. Core Application Mechanism and Adaptation Principles of Gel Ointments (Papillary Ointments)

[0195] This system combines five types of gel ointments corresponding to different syndromes, using the principle of exterior-interior acupoint pairing as its core, along with multiple acupoint pairing methods such as Shu-Mu point pairing, distal-proximal point pairing, and upper-lower point pairing. Following the dynamic regulatory logic of "treating the symptoms in acute cases and addressing the root cause in chronic cases," it organically coordinates these methods to form a comprehensive external medication system that treats both exterior and interior, addresses both symptoms and root causes, regulates both internal and external factors, and addresses both the overall and local aspects of the condition. The exterior-interior acupoint pairing connects the internal and external systems, linking the internal organs and the skin surface; the Shu-Mu point pairing targets and protects the corresponding internal organs; and the distal-proximal and upper-lower point pairings enhance local meridian unblocking and overall tonifying effects. This allows the gel ointment's efficacy to be transmitted along the meridians and precisely act on the affected area, achieving simultaneous intervention at multiple targets to address alcohol toxicity, meridian obstruction, and organ deficiency. This further enhances the compatibility and overall prevention and treatment effect of the combined preparation for various alcohol-related syndromes, achieving a five-dimensional precise correspondence of "syndrome type - ointment - organ-proximal acupoint - body surface acupoint - acupoint pairing method," constructing a three-dimensional external treatment system covering all stages and syndromes of alcohol consumption.

[0196] 1. Early stage of drinking (spleen deficiency and dampness): The main focus is on the symptoms, and the disease is both internal and external. Use a spleen-strengthening and dampness-resolving gel ointment, and combine the spleen and stomach meridian acupoints with the body surface acupoints to treat the symptoms and internal diseases at the same time. This will quickly resolve the dampness caused by alcohol, strengthen the spleen and stomach, and prevent the external pathogens from entering the interior.

[0197] 2. Mid-stage of drinking (damp-heat accumulation): Both the exterior and interior are full, and the underlying deficiency is beginning to emerge. Use a heat-clearing and dampness-resolving gel ointment, and combine the acupoints of the liver, gallbladder, spleen and stomach meridians with the connecting points on the body surface to clear the interior and support the body's vital energy. Clear the internal heat and drain the external dampness, avoiding excessive heat clearing that may damage the underlying deficiency of the spleen and stomach.

[0198] 3. Late stage of alcohol consumption (liver yin deficiency / alcohol toxicity disturbing the mind / alcohol toxicity obstructing the flow of qi): This condition involves both deficiency and excess, with both internal and external symptoms present. We select three types of gel ointments: liver-nourishing and vision-improving, heart-calming and mind-soothing, and blood-activating and meridian-clearing. Using a combination of acupoints for the liver and kidneys / heart and kidneys / liver, spleen, and kidneys, along with meridian points on the head, face, limbs, neck, and shoulders, we treat both the internal and external symptoms. This approach nourishes the qi and yin of the internal organs, clears residual pathogens, removes blood stasis, clears the meridians, and nourishes yin to relieve external symptoms, achieving a comprehensive treatment that addresses both the root cause and the symptoms, preventing critical conditions from developing.

[0199] The core innovation of this system lies in its deep integration of the dosage form advantages of gel ointments (babu plasters) with the core acupoint selection principles of traditional Chinese medicine, the principle of combining specific functional acupoints with meridian-based acupoints, and the theory of syndrome differentiation and treatment. This not only solves the problems of traditional external preparations such as "low transdermal efficiency, high skin irritation, and poor compatibility," but also makes up for the industry pain points of existing external products for alcohol-related harms such as "illogical acupoint selection, neglect of the pathogenesis of both exterior and interior diseases, and superficial effects." It achieves integrated protection and conditioning of alcohol detoxification, organ repair, meridian unblocking, qi and blood harmony, and treatment of both exterior and interior diseases, providing a standardized, precise, and convenient solution for the external treatment of alcohol-related harms using traditional Chinese medicine.

[0200] The acupoints selected in this invention are not a simple combination of conventional hangover remedies in the field. Each acupoint precisely corresponds to a different stage of alcohol damage, and the acupoints work together to form full coverage. This acupoint selection logic is not disclosed in the prior art and cannot be conventionally thought of by those skilled in the art. At the same time, the combination of sugar-free chewing gum formulation with hangover remedies is also a creative breakthrough of existing oral hangover remedies. The combination of the two further highlights the overall inventiveness of this invention.

[0201] Existing hangover remedies mostly rely solely on the efficacy of the drug itself, failing to incorporate the body's meridian conduction and the integrated regulation mechanism of the five internal organs. Furthermore, oral formulations have a single absorption pathway, single target, and limited effectiveness. This invention adds guiding herbs to both the oral sugar-free chewing gum and the external gel ointment. Relying on the guiding herbs' function of "guiding other drugs directly to the affected area," and combining rapid absorption through the oral mucosa with transdermal conduction through meridian acupoints, this invention uses the meridians as the conduction channel. Through the conduction and transfer of the meridians, the drug directly enters the meridian and precisely acts on the damaged organs, achieving a four-fold synergy of "drug properties + mucosal / transdermal absorption + meridian effect + acupoint advantages." Simultaneously, it incorporates multiple effects such as neural and humoral regulation, bio-holographic effects, and generalized effects, blocking alcohol-induced bodily damage through multiple pathways, links, levels, and targets, further amplifying the combined advantages of innovative sugar-free chewing gum formulations and innovative acupoint combination methods.

[0202] Preparation method of combination system formulation

[0203] A. Preparation method of sugar-free chewing gum

[0204] This method is based on the theory of food and medicine sharing the same origin, and combines the chewing and mucosal absorption characteristics of sugar-free chewing gum to optimize the core formula. The specific preparation steps are as follows:

[0205] I. Raw Material Preparation

[0206] 1. Core raw materials: Weigh the core raw materials according to the aforementioned weight ratio. All raw materials should comply with the relevant standards of the Pharmacopoeia of the People's Republic of China and the National Catalogue of Food and Drug Homologous Substances, and remove impurities and mold.

[0207] 2. Preparation of auxiliary materials:

[0208] Gum-based ingredients: sorbitol, xylitol, chewing gum base (such as polyvinyl acetate), totaling approximately 2-3 times the total weight of the core raw materials.

[0209] Functional excipients: glycerin (humectant), maltitol, magnesium stearate (the amount of excipients added is 30%-50% of the total weight of the dried medicinal powder);

[0210] Flavoring and seasoning ingredients: menthol or natural peppermint oil (for flavoring and cooling), citric acid (for flavoring), and edible flavorings (such as natural citrus flavoring, optional).

[0211] II. Extraction and Refining

[0212] 1. Raw material pretreatment: Remove impurities, moldy parts and mud from the above core raw materials (except roses), 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. Pulverize the roses separately and pass them through an 80-100 mesh sieve to obtain a fine powder of roses for later use (this is to maximize the preservation of its aromatic volatile components and avoid loss during the extraction process).

[0213] 2. Extraction of active ingredients: Place the above-mentioned mixed medicinal powder into an extraction device, add 8-12 times the amount of purified water, soak for 30 minutes, and then extract for 1-2 hours using a low-temperature extraction method (extraction temperature 40-50℃). After extraction, filter and collect the filtrate; add 5-6 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.

[0214] 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℃);

[0215] 4. Alcohol precipitation can be performed according to purity requirements (optional): Slowly add 95% ethanol to the thick extract while stirring, until the alcohol content reaches 60%-70%, and refrigerate at 4°C for 12-24 hours. Take the supernatant, filter, and recover the ethanol until there is no alcohol odor to obtain the refined extract.

[0216] 5. Drying: The refined extract (or viscous extract if alcohol precipitation has not been performed) is spray-dried or vacuum-dried to produce a dry extract powder with a moisture content of ≤5% for later use.

[0217] III. Preparation and Mixing of Chewing Gum Base

[0218] 1. Pretreatment of gum base: Select food-grade sugar-free gum base (chew gum base agent), put it into a kneader, heat it to 50-60℃ to soften and swell it, add part of sorbitol, xylitol and all of glycerin, maltitol, and magnesium stearate (the amount added is about 30%-50% of the total amount of the dry powder of medicinal materials), and continue to stir at 50-60℃ to make the gum base fully swell and soften, forming a uniform gum base block, thus making the base gum base.

[0219] 2. Mixing: Add the extract powder obtained in step 2, rose powder, the remaining sorbitol and xylitol, menthol, citric acid, food flavoring and other excipients to the base gum block in sequence.

[0220] 3. Kneading: Knead continuously in a kneader at 45-55℃ for 20-30 minutes until all materials are evenly mixed, forming a chewing gum gel with uniform color, moderate softness and firmness, and no lumps. The kneading process must be maintained under vacuum or normal pressure to avoid the formation of air bubbles.

[0221] IV. Molding and Post-processing

[0222] 1. Extrusion and Rolling: The uniformly mixed chewing gum is extruded into strips through an extruder, and then rolled into sheets of uniform thickness (approximately 2-3 mm) by multiple pairs of rollers.

[0223] 2. Cooling and Shaping: The sheet is passed through a cooling tunnel and cooled at 20-25℃ for 10-15 minutes to set and harden its shape, ensuring stable molding.

[0224] 3. Cutting: Use a cutting machine to cut the cooled sheet into tablets of specified size and shape (such as rectangle or oval), with the weight of a single tablet controlled at 1.0-2.0g / tablet (preferably 1.5g±0.1g).

[0225] 4. Screening: Remove tablets that are irregularly shaped, have large weight differences, or have obvious defects.

[0226] 5. 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 and aroma loss. The outer packaging should clearly indicate product information, production date, and shelf life. After packaging, the tablets should pass quality inspection before being put into storage.

[0227] V. Key Process Points and Precautions

[0228] 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;

[0229] 2. Temperature control: The temperature of the drying, extraction, kneading and molding processes is strictly controlled (core process ≤60℃). Low temperature operation can maximize the retention of bioactive components such as flavonoids and saponins and rose fragrance components in the raw materials and prevent the loss of effective components; the kneading and molding temperature should not be too high to prevent the gum base from softening excessively.

[0230] 3. Moisture control: The moisture content of the extract powder should be ≤5%, and the moisture content of the final product should be ≤3% to ensure the chewability and storage stability of the chewing gum;

[0231] 4. Uniformity control: Ensure that the extract powder and excipients are evenly dispersed in the gum base, and that the uniformity of stirring meets the standards to ensure that the content of the effective ingredients in each piece of chewing gum is uniform and to avoid local color or taste differences.

[0232] 5. Aroma Preservation: Rose petals are crushed and added separately, avoiding the destruction of their volatile aromatic components by high-temperature extraction, thus optimizing the natural flavor and taste of the product.

[0233] B. General preparation method for five types of external acupoint gel ointment (Babu plaster) formulations

[0234] This method is applicable to the preparation of external acupoint gel ointments (Babu ointments) for the aforementioned five syndrome types. It adopts a modular design, and based on a general matrix preparation process, achieves standardized production of the five functional ointments by replacing different types of active Chinese medicine ingredients. This approach balances efficacy stability, good skin compatibility, and industrial feasibility. The specific steps are as follows:

[0235] 1. Raw material preparation

[0236] 1.1 Core Raw Materials

[0237] Weigh out each medicinal and edible or commonly used Chinese herbal medicine raw material according to the aforementioned weight ratio corresponding to the 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 from impurities, mold, and off-odors.

[0238] 1.2 Preparation of auxiliary materials

[0239] 1.2.1 General base (per 100g of ointment):

[0240] Core matrix: Carbomer 9406-7g, hydroxypropyl cellulose (added as needed, adjusted according to the corresponding ratio for each syndrome), glycerin (pharmaceutical grade, 15-20g), propylene glycol 8-12g;

[0241] 1.2.2 Functional excipients: Kaolin / Magnesium Aluminum Silicate 3-5g (filler and thickener), Polyethylene Glycol 400 2-4g (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);

[0242] 1.2.3 Preservative and stabilizing excipients: Ethylparaben / phenoxyethanol 0.1-0.3g (preservative), benzalkonium bromide (can be used as an alternative preservative), disodium edetate 0.01-0.05g (metal ion chelating agent);

[0243] 1.2.4 Other excipients: Lanolin (to improve adhesion and reduce skin irritation; for the blood circulation type, add 2-3g), medical petroleum jelly (for the liver-nourishing and vision-improving type, add 1-2g), purified water to make up to 100g;

[0244] 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.

[0245] 1.2.6 Carrier Excipients

[0246] With a medical non-woven fabric backing and polyethylene release paper (medical protective film), it is suitable for adhesive application, ensuring a firm and easy-to-peel application without leaving any adhesive residue.

[0247] 2. Stepwise preparation method

[0248] 2.1 Preparation of active ingredients (dry ointment / powder) (applicable to all types)

[0249] 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.

[0250] 2.1.2 Extraction of active ingredients: Place the mixed medicinal powder into the extraction equipment, add 8-10 times the amount of purified water, soak for 30 minutes, heat to 85-95℃ (can be finely adjusted to 90-95℃) and reflux extract twice, each time for 1-1.5 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, chuanxiong, angelica) 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.

[0251] 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℃).

[0252] 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.

[0253] 2.2 Preparation of a universal gel matrix

[0254] 2.2.1. Swelling: Slowly sprinkle Carbomer 940 and hydroxypropyl cellulose (added as needed) into purified water accounting for about 40% of the total water volume while stirring. Swell at room temperature for 24 hours, or heat to 50-60℃ to accelerate swelling until completely transparent and free of particles, thus preparing a carbomer gel matrix.

[0255] 2.2.2. Dissolving and dispersing excipients: Mix glycerin, propylene glycol, polyethylene glycol 400, lanolin (and the corresponding micro-adjustment excipients, such as medical petroleum jelly) and heat to 45-55℃, stirring until completely melted and mixed evenly; while stirring, add the mixture to the carbomer swelling solution in sequence and stir evenly.

[0256] 2.2.4 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, delicate, 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 delicate. It is then cooled to room temperature for later use.

[0257] 2.2.5 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 formulation.

[0258] 2.3 Formulation, defoaming, and application of various types of pastes

[0259] 2.3.1. Mixing the ointment: 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.

[0260] 2.3.2. Homogenization and degassing: 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 degassing tank and degas at a vacuum of -0.08 to -0.09 MPa for 15-20 minutes until the paste is smooth and free of visible bubbles.

[0261] 2.3.3. Coating and Forming: Adjust the blade distance of the coating machine to evenly coat 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 / periocular type (sizes 2cm×3cm, 3cm×4cm or 2cmX2cm) 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.

[0262] 2.4 Molding, Post-processing and Packaging Inspection

[0263] 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 stabilize the paste. Then cut it according to the preset specifications using a slicer, and remove products with uneven coating, air bubbles, or damage to obtain the formed external acupoint gel paste (babu paste).

[0264] 2.4.2 Packaging: The molded products are classified according to the certificate type and individually packaged in aluminum foil bags or sealed bags (2 patches per bag, which can be adjusted to 6 patches or 12 patches per box as needed). The outer packaging is labeled with the certificate type name, the appropriate acupoints and the instructions for use. After inner packaging, the products are placed into a cardboard box and labeled to complete the outer packaging.

[0265] 2.4.3 Quality Inspection: The finished product undergoes comprehensive testing, with core indicators including: ① Appearance: The ointment surface is uniform, the color is consistent, and there are no impurities or bubbles; ② pH value: 5.5-7.5; ③ Ointment content: Meets the labeled amount (e.g., each patch contains ≥1.6g of ointment); ④ Excipient properties / peel strength: Meets the relevant requirements for poultices in the Chinese Pharmacopoeia; ⑤ Microbial limits: Meets the regulations; ⑥ Sterility, ointment adhesiveness, and skin irritation: Meets the standards; ⑦ Storage stability: Accelerated testing at 40℃±2℃ and RH75%±5% for 6 months shows no significant changes in any indicators; After passing the inspection, the product is stored in the warehouse, thus obtaining the corresponding type of external acupoint gel ointment (poultice).

[0266] 3. Key process control points

[0267] 3.1. Carbomer swelling: It must be completely swollen without any particle residue, otherwise it will affect the uniformity and viscosity of the ointment, and thus affect the application effect.

[0268] 3.2. pH adjustment: Triethanolamine should be added slowly and stirred quickly to prevent localized excessive alkalinity, which could lead to gel demulsification or thinning, and to ensure matrix stability.

[0269] 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.

[0270] 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.

[0271] 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 be controlled to meet pharmaceutical standards to avoid the introduction of impurities and microorganisms.

[0272] 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.

[0273] 4. Characteristics and advantages of the preparation method

[0274] 4.1 Standardization and Flexibility: The universal matrix process is stable, and five different functional ointments can be quickly produced by changing the "active ingredient module". It has high production efficiency, good quality consistency, and is suitable for large-scale production needs.

[0275] 4.2. Excellent performance: The resulting ointment has a large drug loading capacity, good transdermal permeability, strong moisturizing properties, good skin compatibility, no pulling or pain sensation, and leaves no adhesive residue after peeling, thus improving the comfort of application.

[0276] 4.3 High adaptability: By adjusting the coating thickness, backing material and application specifications, it can flexibly adapt to the application needs of different parts of the body (such as joints, around the eyes, soles of the feet, torso, and limbs).

[0277] 4.4 Syndrome Differentiation and Adaptation: Taking into account the TCM syndrome differentiation and treatment concept, the five types of special active ingredients accurately correspond to different syndrome types. Combined with the acupoint targeting characteristics, it ensures that the efficacy of the preparation is accurately exerted and adapts to the needs of external conditioning.

[0278] 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 gel ointments (babu ointments), taking into account operability, stability and practicality.

[0279] Other forms of topical preparations

[0280] The aforementioned external gel ointment (babu ointment) can be prepared in various other forms of external Chinese medicine preparations, including but not limited to rubber plasters, ointments, creams, gels, liniments, tinctures, oils, pastes, films, and sprays, depending on actual clinical needs and the preparation process can be adjusted.

[0281] A combined systemic formulation for preventing and treating the harms of alcohol consumption, prepared using the above methods:

[0282] A. Sugar-free oral chewing gum preparation

[0283] 1. Product Specifications

[0284] Dosage form: Sugar-free chewing gum (chewable tablets)

[0285] Weight per piece: 1.5g ± 0.1g

[0286] Packaging specifications: 6 tablets per blister pack, 2 blister packs per box (12 tablets in total); or 30 tablets per bottle.

[0287] Appearance: Smooth oval or square tablets with uniform color and the unique natural plant aroma of the raw materials (such as the compound fragrance of kudzu flower, dried tangerine peel, and rose), without any off-odor.

[0288] 2. Usage and Dosage

[0289] ① Routine conditioning and prevention: It is recommended to chew 1 tablet 30-60 minutes before drinking to form a protective film on the oral mucosa in advance, inhibit the rapid absorption of alcohol, and reduce the initial damage of alcohol to the internal organs.

[0290] ② Instant hangover relief and discomfort relief: Chew 1-2 tablets immediately during or after drinking to quickly relieve symptoms such as dizziness, nausea, and stomach discomfort. Repeat every 2-3 hours depending on the severity of discomfort, but do not exceed 4 tablets within 24 hours.

[0291] ③ Daily maintenance: On non-alcohol-consuming days, chew one tablet daily for daily liver protection, spleen and stomach strengthening, qi regulation, enhancing the body's resistance to repeated alcohol poisoning.

[0292] Directions for use: Take out the chewing gum, place it in your mouth and chew until the active ingredients are fully released (about 5-10 minutes). Once the taste becomes milder, you can spit it out or swallow it (the gum base is indigestible, so spitting it out is recommended). No water is needed to take it.

[0293] B. External acupoint gel ointment (Babu ointment)

[0294] 1. Product Specifications

[0295] Dosage form: Hydrophilic gel ointment (poop ointment)

[0296] Patch size: Two sizes are available depending on the acupoint location:

[0297] General type (trunk and limb acupoints): 4.0cm×4.0cm, with a medicated paste thickness of about 1.0mm, and each patch contains about 2.0g of paste.

[0298] Face / Eye Special Type: 2.0cm×2.0cm, with a medicated paste thickness of approximately 0.5mm, each patch containing approximately 0.5g of paste, and a lighter, more breathable texture.

[0299] Packaging specifications: One patch is individually sealed in each bag. Each box contains 6 or 12 patches of the same formula.

[0300] Appearance: The paste is a uniform brown to light brown color, with a soft and pliable texture and a mild odor. The backing is non-woven fabric, and the release layer is a polyethylene film.

[0301] 2. Usage and Dosage

[0302] Differentiation and selection: Based on your main symptoms, select the corresponding syndrome type ointment (e.g., choose the spleen-strengthening and dampness-resolving type for abdominal distension and greasy tongue coating after drinking; choose the heat-clearing and dampness-resolving type for hypochondriac pain and bitter taste in the mouth after drinking, etc.).

[0303] Acupoint location: Clean and dry the skin where the patch will be applied. Refer to the acupoint diagram in the product instructions for location.

[0304] Examples of commonly used core acupoints:

[0305] Liver protection and hangover relief: Qimen (chest), Ganshu (back), Taichong (foot).

[0306] To soothe the stomach and stop vomiting: Zhongwan (abdomen), Neiguan (forearm), and Zusanli (lower leg).

[0307] To refresh and calm the mind: Baihui (top of the head), Shenmen (wrist), and Yongquan (sole of the foot).

[0308] Application method: Remove the protective layer, apply the plaster to the accurately positioned acupoint, and gently press the edges to make it adhere.

[0309] Dosage and timing per dose:

[0310] Routine health care: Select 2-3 main acupoints for application each time, and each patch lasts for 6-8 hours.

[0311] For acute discomfort (such as after severe intoxication): Apply to 4-6 acupoints simultaneously (depending on the syndrome type combination), each patch lasting 4-6 hours. Remove the patch after symptoms are relieved.

[0312] ① Daily care: Use 2-3 times a week.

[0313] ②Pre- and post-drinking conditioning: It is recommended to use once within 24 hours before or after drinking alcohol.

[0314] Recommended course of treatment: Use continuously for 14-28 days as one treatment cycle. After the cycle, use intermittently as needed.

[0315] B. Recommendations for the synergistic use of combination system formulations

[0316] To achieve the best results of "internal regulation and external prevention, addressing both symptoms and root causes," the following synergistic approach is recommended:

[0317] 1. Pre-drinking prevention plan: 30 minutes before drinking: Chew one piece of sugar-free gum; at the same time: Apply a spleen-strengthening and dampness-resolving gel or heat-clearing and dampness-resolving gel to acupoints such as Zhongwan and Zusanli.

[0318] 2. Immediate hangover remedies: Immediately after drinking: Chew 1-2 pieces of sugar-free gum; At the same time: Apply the corresponding plaster according to the symptoms. For example, apply Baihui for dizziness, Neiguan for nausea, and Qimen and Taichong for hypochondriac pain.

[0319] 3. Long-term conditioning plan (for long-term drinkers): Daily or every other day: Chew one sugar-free gum for daily maintenance. 2-3 times a week: Select the corresponding gel plaster according to your constitution (e.g., liver stagnation, spleen deficiency) and apply it to the relevant acupoints (e.g., Liver Shu, Spleen Shu, Sanyinjiao, etc.). Apply once a day for 6-8 hours each time. Continuous application for 14-28 days constitutes one conditioning cycle. After each cycle, rest for 1-2 days before continuing.

[0320] Precautions:

[0321] 1. If redness, itching, stinging, or other discomfort occurs on the local skin after applying the topical ointment, remove it immediately and wash the area with clean water. Use with caution if you have allergies.

[0322] 2. Do not apply to areas of skin with broken, ulcerated, eczema, or inflammation; use with caution by pregnant or breastfeeding women.

[0323] The combined system preparation for preventing and treating the harms of drinking, prepared using the above methods, has the following functions: fresh breath and rapid sobering up. Through multiple target effects such as refreshing the mind and calming the nerves, relieving anxiety and irritability, harmonizing the stomach and relieving nausea, strengthening the spleen and removing dampness, soothing the liver and unblocking the meridians, and nourishing qi and yin, it effectively improves discomfort symptoms such as dizziness after drinking. At the same time, it achieves the effects of detoxifying alcohol, delaying alcohol absorption, protecting the brain, heart, liver, spleen, stomach and other organs, preventing chronic alcohol damage, and is suitable for all drinking scenarios and daily maintenance. It has high safety and is suitable for a wide range of people.

[0324] Summary of the advantages of this invention

[0325] Existing hangover remedies generally suffer from a single mechanism of action: oral formulations mostly rely on gastrointestinal absorption, resulting in slow onset of action and bioavailability easily affected by food; topical formulations often lack scientifically designed penetration enhancers and targeted therapies, making it difficult for the drug to penetrate deeply. Their common problem lies in the failure to organically combine the advantages of modern pharmaceutics with the holistic regulation theory of "meridians and internal organs" in Traditional Chinese Medicine, leading to dispersed target points, slow onset of action, and limited overall efficacy.

[0326] This invention, through dosage form innovation and theoretical integration, has pioneered a novel mechanism of action characterized by "dual-channel drug delivery and quadruple synergistic enhancement," achieving a fundamental breakthrough over existing technologies.

[0327] I. Dual-channel targeted delivery system:

[0328] 1. Rapid absorption channel through oral mucosa: Using sugar-free chewing gum as a carrier, active ingredients such as puerarin and trichosanthes saponins are directly absorbed into the blood through the oral and sublingual mucosa by chewing, partially bypassing the first-pass effect of the liver, so as to achieve rapid onset of relief (symptomatic relief) for discomfort after drinking (such as dizziness and nausea).

[0329] 2. Meridian and acupoint transdermal sustained-release channel: Using external gel ointment as a carrier, combined with penetration enhancers such as azone and "guiding drugs" (such as vinegar-processed Bupleurum to guide the drug into the liver meridian), the drug components are absorbed transdermally in a targeted and sustained manner through specific acupoints. With the help of the conduction of meridians, the drug power is precisely targeted to the damaged organs such as the liver, stomach, and heart (treating the root cause).

[0330] II. Four-fold synergistic efficiency enhancement mechanism:

[0331] 1. Synergistic effect of medicinal chemistry: The combination of oral and topical medications follows the principle of "principal, assistant, adjuvant and guide", with multiple components and multiple targets exerting comprehensive medicinal effects such as detoxification, liver and stomach protection, and calming the mind.

[0332] 2. Synergistic Pharmacokinetics of Dosage Forms: The combination of the immediate-release properties of chewing gum and the sustained-release properties of gel ointments takes into account the different needs of immediate relief and long-term conditioning, forming a complementary therapeutic effect over time.

[0333] 3. Meridian-Acupoint Biophysical Synergy: Acupoints selected based on innovative theories such as the "exterior-interior acupoint matching method" are not only drug administration sites, but their own benign regulatory effects on the internal organs are superimposed and enhanced with the drug effects, achieving a biological effect of "1+1>2".

[0334] 4. Overall regulation and synergy: This dual-channel system simultaneously stimulates the regulation of the neuro-endocrine-immune network, and through multi-system and multi-level integration, it comprehensively restores the homeostasis of the body that is imbalanced due to alcohol consumption.

[0335] The core innovation of this integrated mechanism lies in combining the highly scenario-adaptable modern dosage form of "sugar-free chewing gum" with the ancient wisdom of traditional Chinese medicine's "meridian and acupoint targeted drug delivery," supplemented by innovative acupoint matching theory. This is not a simple superposition of forms, but a systematic and logical design based on a profound understanding of the pathophysiological processes of alcohol-related harms. This fusion of "modern convenient dosage form × traditional targeting theory × innovative acupoint matching principles" is something that those skilled in the art could hardly have foreseen under the guidance of existing technologies, constituting the prominent substantive feature of this invention.

[0336] In summary, this invention provides a comprehensive prevention and treatment solution for the harms of alcohol consumption, integrating prevention, treatment, and conditioning. Its fundamental purpose is to thoroughly solve the series of fragmented technical problems in existing technologies—namely, that are "effective but inconvenient, convenient but not addressing the root cause, imprecise for external applications, and good-tasting but ineffective"—through the aforementioned multi-dimensional and systematic innovative design.

[0337] The significant technical effects and advancements brought about by this invention are reflected in:

[0338] 1. Revolutionary improvement in user experience: The sugar-free chewing gum form seamlessly integrates health intervention into social drinking occasions. It is discreet, convenient, and requires no water, while simultaneously solving the problem of bad breath, greatly improving user compliance and making "prevention of disease" and instant hangover relief easy daily habits to maintain.

[0339] 2. A systemic leap in prevention and treatment efficacy: Through the synergistic effect of "oral chewing gum (quick-acting symptomatic relief) + external ointment (slow-acting root cause treatment)" and the dual-channel targeting of "mucosal absorption + meridian transdermal absorption", it achieves full-cycle coverage from rapid hangover relief to deep repair of internal organs and long-term prevention of recurrence, resulting in a more comprehensive, in-depth and lasting prevention and treatment effect.

[0340] 3. Creative integration of technical theories: The theory of food and medicine sharing the same origin, modern transdermal drug delivery technology, traditional Chinese medicine meridian theory and innovative acupoint combination method are deeply integrated across disciplines to form a core technology system with independent intellectual property rights, providing a novel and highly valuable paradigm for the modernization of traditional Chinese medicine and the innovation of health products.

[0341] Therefore, the technical solution of this invention is not an obvious combination or improvement compared with all existing technologies, but a creative achievement with outstanding substantive features and significant progress in the process of solving long-standing industry technical pain points, and has extremely high market application value and industrial promotion prospects. Detailed implementation method:

[0342] This embodiment discloses a combination of oral and external traditional Chinese medicine preparations for preventing the harms of alcohol consumption, including oral sugar-free chewing gum and external acupoint gel ointment (Babu plaster). The technical solution of the present invention will be clearly and completely described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present invention and are not intended to limit the present invention.

[0343] Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0344] Example 1: Preparation of Sugar-Free Oral Gum

[0345] 1. Raw material ratio: Core raw materials (2 parts kudzu flower, 2 parts dried kudzu root, 2 parts bitter orange seeds, 2 parts acorus tatarinowii, 0.8 parts vinegar-processed bupleurum, 0.8 parts dried tangerine peel, 0.8 parts poria cocos, 0.8 parts dried jujube, 0.3 parts rose); Excipients (12 parts sorbitol, 8 parts xylitol, 10 parts chewing gum base, 2 parts glycerin, 0.2 parts menthol, 0.1 parts citric acid).

[0346] 2. Extraction and purification: After pretreatment of the raw materials, 10 times the amount of purified water was added, and the mixture was refluxed at 90°C twice, each time for 1.2 hours. The initial filtrate was concentrated under reduced pressure at 65°C and a vacuum degree of -0.07MPa to a thick extract with a relative density of 1.15 (measured at 60°C). Without alcohol precipitation, the extract powder was directly vacuum dried to obtain the extract powder (moisture content 4.2%).

[0347] 3. Preparation and molding: The gel base swells and softens at 55℃, and excipients, extract powder, and rose powder are added. The mixture is kneaded at 50℃ for 25 minutes. The mixture is then pressed into 2.5mm thick sheets by extrusion rollers, cooled and shaped at 20℃ for 12 minutes, and cut into 1.5g / tablet oval tablets. The tablets are individually packaged in aluminum foil and put into storage after passing inspection.

[0348] Example 2: Preparation of a medicinal material replacement scheme for oral sugar-free chewing gum

[0349] The difference between this embodiment and Example 1 is that the three medicinal materials for the oral sugar-free chewing gum in the compound are replaced in equal amounts. The remaining raw material ratios, preparation methods, and application methods are the same as in Example 1. The specific replacement scheme is as follows (unit: g):

[0350] Option 1: Replace 8g of dried tangerine peel in Example 1 with 8g of Buddha's hand, while keeping the other ingredients and weights unchanged: 25g of dried kudzu root, 25g of bitter orange seeds, 25g of kudzu flower, 25g of acorus tatarinowii, 8g of Buddha's hand, 8g of poria cocos, 8g of dried jujube (pitted), 8g of vinegar-processed bupleurum, and 3g of rose.

[0351] Option 2: Replace 8g of Poria cocos in Example 1 with 8g of Coix lacryma-jobi, while keeping the other ingredients and their weights unchanged: 25g of dried kudzu root, 25g of Japanese raisin tree fruit, 25g of kudzu flower, 25g of Acorus tatarinowii, 8g of dried tangerine peel, 8g of Coix lacryma-jobi, 8g of dried jujube (pitted), 8g of vinegar-processed Bupleurum chinense, and 3g of rose petals.

[0352] Option 3: Replace 8g of dried jujubes (pitted) in Example 1 with 8g of licorice, while keeping the other ingredients and their weights unchanged: 25g dried kudzu root, 25g bitter orange seeds, 25g kudzu flower, 25g acorus tatarinowii, 8g dried tangerine peel, 8g poria cocos, 8g licorice, 8g vinegar-processed bupleurum, and 3g rose petals.

[0353] In the above replacement scheme, Buddha's Hand, Coix Seed, and Licorice all meet the relevant standards of the Pharmacopoeia of the People's Republic of China (2020 Edition, Part I). The pretreatment methods refer to the pretreatment requirements of the corresponding replacement medicinal materials (Buddha's Hand refers to the pretreatment method of dried tangerine peel, Coix Seed refers to the pretreatment method of Poria cocos, and Licorice refers to the pretreatment method of dried jujube). The sugar-free chewing gum prepared after the replacement has the same efficacy in relieving hangovers, protecting the liver, and strengthening the spleen and soothing the liver as in Example 1.

[0354] Example 3: Preparation of oral sugar-free chewing gum (other oral dosage forms - mouthwash tablets)

[0355] This embodiment uses the core raw materials and excipients of Example 1 as a basis to prepare an oral preparation as a mouthwash lozenge. The specific preparation steps are basically the same as those of the oral sugar-free chewing gum in Example 1, with the only difference being:

[0356] 1. Adjustment of excipients: Remove the chewing gum base agent and add microcrystalline cellulose (filler, amount is 1.5 times the total weight of core raw materials) and magnesium stearate (lubricant, amount is 0.1 times the total weight of core raw materials). Sorbitol, xylitol, menthol and citric acid are retained. The ratio of sorbitol to xylitol is adjusted to 1:1. The total amount is still twice the total weight of core raw materials to enhance the tablet's formability and mouth-cleansing effect.

[0357] 2. Preparation steps adjustment: There is no need to perform the steps of gel base swelling, kneading, and extrusion rolling. The extract powder and rose fine powder prepared in Example 1 are mixed evenly with the adjusted excipients and stirred for 15 minutes using a high-speed mixer to ensure material uniformity. Then, tablets are made using a tablet press with the tableting pressure controlled at 8-10 MPa to produce round tablets with a diameter of 0.8 cm and a thickness of 0.2 cm, and the weight of a single tablet is controlled at 0.5 g ± 0.05 g.

[0358] 3. Drying and Packaging: Place the compressed lozenges in a 55℃ hot air circulating drying oven and dry them until the moisture content is ≤3%. After drying, remove any fragments and lozenges with excessive weight differences. Pack them individually in aluminum foil (12 lozenges per blister pack). After passing inspection, store them in the warehouse to obtain the finished product of the mouth-clearing lozenges.

[0359] Testing revealed that the breath freshener has a refreshing taste, dissolves easily without any gritty feeling, and provides a long-lasting minty coolness, quickly freshening breath. The retention rate of active ingredients is consistent with that in Example 1, effectively relieving discomfort such as dry mouth and bad breath after drinking alcohol. It is suitable for immediate breath freshening after drinking and for daily breath care.

[0360] Example 4: Preparation of a topical liver-nourishing and vision-improving gel ointment (Babu ointment)

[0361] 1. Raw material ratio (100kg finished product): 2.0kg wolfberry, 1.5kg ophiopogon japonicus, 1.5kg angelica sinensis, 1.5kg salvia miltiorrhiza, 1.5kg red peony root, 1.5kg bupleurum chinense, 0.3kg peppermint, 0.3kg borneol; Matrix: 0.8kg carbomer 940, 18.0kg glycerin, 10.0kg propylene glycol, 4.0kg magnesium aluminum silicate, 3.0kg polyethylene glycol 400, 1.0kg amino ketone, 0.2kg ethylparaben, 0.03kg disodium edetate, 1.0kg medical petrolatum, appropriate amount of triethanolamine, purified water added to 100kg.

[0362] 2. Preparation of active ingredients

[0363] 2.1 Pretreatment: Wash the medicinal materials (except peppermint and borneol), dry them at 58℃, and pulverize them through a 20-mesh sieve. Peppermint is pulverized separately through a 100-mesh sieve.

[0364] 2.2 Extraction: Add 9 times the volume of purified water to the crude powder of the medicinal material, soak for 30 min, and reflux extract twice at 92℃, 1.2 h each time. Combine the filtrates and filter through a 200 mesh.

[0365] 2.3 Concentration and Drying: The filtrate was concentrated to a relative density of 1.12 (60℃) at 63℃ and -0.075MPa, and then spray-dried (inlet air 170℃, outlet air 85℃) to obtain a dry powder (moisture ≤5.0%), which was then passed through a 100-mesh sieve.

[0366] 2.4 Mixing: Pre-dissolve borneol in ethanol, mix it with dry ointment powder and peppermint powder to obtain active ingredient complex powder, and set aside.

[0367] 3. Matrix preparation

[0368] 3.1. Swelling: Carbomer 940 is added to 40% purified water and heated at 55°C with stirring until it becomes completely transparent and swollen.

[0369] 3.2 Mixing: Add glycerin, propylene glycol, polyethylene glycol 400, magnesium aluminum silicate, and petrolatum in sequence, and stir until well mixed.

[0370] 3.3 Gel formation: Add triethanolamine to adjust the pH to 6.5, homogenize at low speed for 4 minutes, and cool for later use.

[0371] 4. Paste preparation and molding

[0372] 4.1 Mixing: Add the active ingredient compound powder, amino ketone, and preservative to the matrix and stir initially until homogeneous.

[0373] 4.2 Homogenization and degassing: Homogenize at 1500 rpm for 12 min, then degas under vacuum at -0.085 MPa for 18 min to obtain a fine, bubble-free paste.

[0374] 4.3 Coating and Cutting: The ointment is evenly coated on non-woven fabric (0.6mm thick), covered with an anti-adhesive film, and cut into 3×4cm eye patches.

[0375] 4.4 Packaging: Individually sealed in aluminum foil bags.

[0376] Example 5: External application of liver-nourishing and vision-improving gel ointment (preparation of other external preparations in the form of rubber patches)

[0377] Rubber plasters use rubber as the main matrix, have strong adhesion, are easy to carry, and are especially suitable for acupoints that require long-term stable application.

[0378] 1. Raw materials and formula (based on 1000g of finished product)

[0379] Ingredients: Take 50g of the "Liver-Nourishing and Vision-Improving Active Ingredient Complex Powder" prepared in Example 4 (i.e., concentrated, dried, and mixed extracts of medicinal herbs such as wolfberry, ophiopogon japonicus, angelica sinensis, salvia miltiorrhiza, red peony root, bupleurum chinense, peppermint, and borneol).

[0380] Rubber matrix: 200g natural rubber (or synthetic polyisobutylene), 80g rosin (tackifier), 30g zinc oxide (filler, weak astringent), 20g lanolin (softener), 20g petrolatum (softener).

[0381] Solvent: Gasoline (No. 120 solvent oil) or 600g of heptane (for dissolving rubber).

[0382] Backing material: medical grade elastic fabric or perforated non-woven fabric.

[0383] 2. Preparation method

[0384] Rubber dissolution: In a sealed mixing tank, cut natural rubber into small pieces, add gasoline / heptane, and stir until completely dissolved into a uniform slurry.

[0385] Mixing auxiliary materials: Add the molten rosin, lanolin, and petrolatum to the adhesive in sequence and stir evenly. Then add zinc oxide and continue stirring until a homogeneous and fine matrix slurry is formed.

[0386] Adding the medicinal powder: Slowly add the "liver-nourishing and vision-improving active ingredient compound powder" to the matrix slurry, and stir at high speed (or use a colloid mill) for 1-2 hours to ensure that the medicinal powder is fully and evenly dispersed to obtain the medicated slurry.

[0387] Coating and Drying: Apply the medicated adhesive evenly to the backing material, controlling the coating thickness to approximately 0.2-0.3 mm. Place the coated material into a hot air circulating drying tunnel and dry at 50-60℃ for 20-30 minutes to evaporate most of the solvent.

[0388] Lining and Cutting: After drying, cover the paste surface with an anti-stick layer (such as glassine paper). Cut to the preset size (such as 4cm x 4cm, 7cm x 10cm).

[0389] Inner packaging: After slicing, immediately seal each slice individually in an aluminum foil bag.

[0390] Example 6: Validation of the synergistic effect of oral and topical combination formulations

[0391] To verify the synergistic effect of the oral sugar-free chewing gum preparation and the external acupoint gel ointment (Babu ointment) of this invention, the following verification experiment was designed to observe the synergistic effect of the two in preventing the harm of drinking alcohol, in combination with the oral and external preparations prepared above.

[0392] Sixty volunteers with a history of long-term alcohol consumption (daily alcohol intake ≥50ml, drinking history ≥1 year) and symptoms such as post-drinking bloating, dizziness, hypochondriac pain, insomnia, and halitosis were randomly divided into three groups of 20 each. There were no significant differences in age, drinking history, or symptom severity among the three groups (P>0.05), making them comparable. The following intervention protocols were used for 30 consecutive days, and symptom improvement and organ protection effects were observed:

[0393] Group 1 (Oral administration group): The oral sugar-free chewing gum preparation prepared in Example 1 was used only, 3 times a day, 1 tablet each time, chewed immediately after drinking alcohol for 15-20 minutes, and 1 tablet in the morning and evening on non-drinking days;

[0394] Group 2 (External Application Group): Only use the alcohol-toxic and blood stasis type external acupoint gel ointment (babu ointment, prepared according to this method, the active ingredient is alcohol-toxic and blood stasis type dry ointment powder), 1 patch per day, applied to the liver shu acupoint and stomach shu acupoint, each application for 12 hours, and changed once a day;

[0395] Group 3 (Combination Group): The group adopted a combined intervention of oral and topical medications, with the same usage as Group 1 and Group 2. Specifically, the sugar-free oral chewing gum of Example 1 and the topical acupoint gel ointment for alcohol toxicity and blood stasis were used simultaneously, with the usage being consistent with the individual interventions of the two groups.

[0396] After 30 days of intervention, the symptom scoring method was used to evaluate the improvement effect (complete disappearance of symptoms was considered cured, significant symptom relief was considered effective, and no improvement or worsening of symptoms was considered ineffective; the effective rate = (number of cured cases + number of effective cases) / total number of cases × 100%). Simultaneously, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in volunteers were measured to evaluate the liver protective effect. Specific results are as follows:

[0397] 1. Effective rate of symptom improvement: The effective rate of symptom improvement in group 1 was 75%, the effective rate of symptom improvement in group 2 was 70%, and the effective rate of symptom improvement in group 3 was 95%. The effective rate of group 3 was significantly better than that of group 1 and group 2 (P<0.05);

[0398] 2. Liver function indicators: After intervention, ALT and AST levels in groups 1 and 2 decreased compared with those before intervention, but the decrease was small; after intervention, ALT and AST levels in group 3 decreased significantly compared with those before intervention (P<0.05), and were significantly lower than those in groups 1 and 2 after intervention (P<0.05).

[0399] 3. Overall evaluation: Volunteers in Group 3 experienced significantly faster relief from immediate discomfort such as bloating, dizziness, and rib pain after drinking alcohol compared to those in Groups 1 and 2. After long-term intervention, chronic symptoms such as insomnia and halitosis improved more significantly, and the liver function protection effect was better.

[0400] The results show that the oral sugar-free chewing gum preparation and the external acupoint gel ointment (Babu ointment) of the present invention have a significant synergistic effect. The combination of the two achieves both internal and external treatment, addressing both the symptoms and the root cause. Compared with oral or external use alone, it can significantly improve the effect of preventing and treating the harm of drinking, relieve immediate discomfort after drinking more quickly, protect organs such as the liver and stomach more comprehensively, block the transmission of alcohol toxins, and has a significant synergistic effect, which is suitable for the maintenance needs of people who drink alcohol for a long time.

[0401] Specific Examples and Clinical Reports

[0402] From May 2006 to January 2026, a clinical intervention observation was conducted on 360 patients with long-term alcohol consumption-related symptoms using the combined system formulation for preventing and treating the harms of alcohol consumption provided by this invention (oral sugar-free chewing gum + external acupoint gel ointment). The results showed that the treatment group (using the formulation of this invention) was significantly superior to the control group treated with conventional drugs in improving alcohol-related symptoms, increasing the clinical cure rate, and achieving an overall effective rate, with good safety. The details are reported below:

[0403] 1. Clinical Data

[0404] 1.1 General Information

[0405] Three hundred and sixty outpatients aged 25-70 years with a daily alcohol consumption >50g (based on pure alcohol), a drinking history >5 years, and at least one alcohol-related symptom (such as dizziness, nausea, discomfort in the liver area, abdominal distension, insomnia, fatigue, dry eyes, etc.) were selected. Patients with severe hepatic or renal insufficiency, gastrointestinal bleeding, mental illness, allergy to the study drugs, or pregnancy were excluded after screening. Patients were randomly assigned to a treatment group and a control group using a random number table, with 180 patients in each group.

[0406] 1.2 Clinical Manifestations and TCM Syndrome Differentiation

[0407] 1.2 Clinical Manifestations:

[0408] Based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" and the consensus on the diagnosis and treatment of alcohol-related harms using traditional Chinese medicine, the enrolled patients were classified according to traditional Chinese medicine syndrome differentiation. The classification and baseline characteristics of the two groups are as follows: Distribution of clinical manifestations in the two groups at admission.

[0409] Clinical syndrome Treatment group (cases) Control group (cases) Spleen deficiency with dampness syndrome 17 16 Damp-heat accumulation syndrome 33 34 Alcohol-induced liver damage 25 26 Alcohol-induced mental disturbance 29 28 Alcohol-induced blood stasis syndrome 20 21 Mixed and combined certificates 56 55

[0410] There were no statistically significant differences in general characteristics such as age, average years of alcohol consumption, daily alcohol consumption, and distribution of TCM syndrome types between the two groups of patients (P>0.05), indicating that they were comparable.

[0411] 2. Treatment methods

[0412] 2.1 Treatment group

[0413] Treatment was performed using the combination of the present invention: "oral sugar-free chewing gum preparation + external acupoint gel ointment (Babu ointment)".

[0414] For internal use: On days when drinking alcohol, chew sugar-free gum 3-4 times a day, 1 piece each time (about 1.5g / piece), chewing for 5-10 minutes each time (not exceeding 4 pieces in 24 hours). On days when not drinking alcohol, chew sugar-free gum 1-2 pieces a day.

[0415] External use: Select the corresponding external gel ointment according to the patient's syndrome differentiation and apply it according to the "pathogenesis-acupoint-acupoint combination method":

[0416] For spleen deficiency with dampness: apply plaster to Zhongwan (CV12), Zusanli (ST36), Zhangmen (LR13), and Yinlingquan (SP9).

[0417] For damp-heat accumulation syndrome: apply plaster to the Liver Shu point, Qimen point, Yanglingquan point, and Taichong point.

[0418] For liver damage caused by alcohol poisoning: apply plasters to the Liver Shu, Kidney Shu, Taixi, Sanyinjiao, and around the eyes (Taiyang and Zanzhu).

[0419] For symptoms of alcohol poisoning disturbing the mind: apply plasters to Neiguan, Shenmen, Baihui, and Yongquan acupoints.

[0420] For alcohol poisoning and blood stasis in the meridians: apply plasters to Xuehai, Sanyinjiao, Zusanli, and Ashi points.

[0421] Mixed syndrome: Select the combination of acupoints corresponding to the main syndrome.

[0422] Usage: Apply one patch to each acupoint for 6-8 hours each time, 2-3 times a week.

[0423] Treatment course: One course of treatment consists of 4 consecutive weeks (28 days). During the treatment period, patients are advised to control their alcohol intake, adjust their diet, and maintain a regular sleep schedule.

[0424] 2.2 Control Group

[0425] Based on the patient's main syndrome pattern, commercially available conventional Chinese patent medicines were selected for symptomatic treatment:

[0426] For spleen deficiency with dampness: take 6g of Ginseng and Atractylodes Macrocephala Pills orally, 3 times a day.

[0427] For damp-heat accumulation syndrome: take Yin Zhi Huang granules orally, 3g each time, 3 times a day.

[0428] For liver damage caused by alcohol poisoning: Take 4 liver-protecting tablets orally, 3 times a day.

[0429] For symptoms of alcohol poisoning disturbing the mind: Take 6g of Zhusha Anshen Pills orally twice a day.

[0430] For alcohol-induced blood stasis obstructing the meridians: Take Xuefu Zhuyu Pills orally, one pill each time, twice a day.

[0431] For mixed symptoms: Based on the primary and secondary symptoms, select 2 to 3 corresponding traditional Chinese medicines to take in combination or alternately, with an interval of more than 1 hour between doses.

[0432] Treatment duration: 4 weeks, with the same lifestyle adjustments as the treatment group during the treatment period.

[0433] 3. Efficacy Analysis

[0434] 3.1 Criteria for Evaluating Therapeutic Effect

[0435] Formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and the symptom scoring method:

[0436] Clinical cure: The main symptoms and signs related to alcohol consumption have disappeared or have basically disappeared, and the symptom score has decreased by ≥95%.

[0437] Significant effect: Symptoms and signs are significantly improved, and the symptom score is reduced by ≥70% and <95%.

[0438] Effective: Symptoms and signs improve, and symptom scores decrease by ≥30% and <70%.

[0439] Ineffective: Symptoms and signs do not improve significantly, or worsen, and symptom score decreases by <30%.

[0440] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0441] 3.2 Treatment Results

[0442] The following table shows the comparison of the efficacy between the two groups after one course of treatment:

[0443]

[0444] The above results, after statistical processing (P<0.01), indicate that there are significant differences in cure rate and total effective rate between the treatment group and the control group, with the treatment group showing significantly better efficacy than the control group. At the same time, no obvious toxic side effects or allergic reactions were found in the 180 patients in the treatment group during and after treatment, indicating good safety.

[0445] 4. Typical Cases

[0446] Case 1 (Alcohol-induced liver damage complicated by alcohol-induced blood stasis): Mr. Gao, male, 29 years old. Chief complaint: Dry mouth and bitter taste, dull pain in the liver area, and stiff and sore neck and shoulders for 3 months after long-term alcohol consumption, worsening for 1 week. The patient has a 6-year history of alcohol consumption, averaging about 50g of alcohol per day. He usually works late into the night using a computer and mobile phone. He has taken liver-protecting health supplements, but the symptoms have not been significantly relieved. Symptoms: Pale complexion, dry mouth and bitter taste, dull pain in the liver area, dry eyes, blurred vision, inability to concentrate for long periods, stiff and stabbing pain in the neck and shoulders, limited movement, accompanied by dizziness, blurred vision, numbness in the limbs, and easy abdominal distension and fatigue after drinking. Red tongue with little coating, thin white coating, and weak pulse. Diagnosis: Alcohol-induced liver damage complicated by alcohol-induced blood stasis (alcohol-induced liver damage secondary to eye and neck / shoulder symptoms).

[0447] Treatment Group (Combined Preparation of this Invention): This treatment group was established to evaluate the comprehensive efficacy of this invention for complex concurrent symptoms. Treatment Plan: ① Oral administration of sugar-free chewing gum (function: clears alcohol toxins and nourishes liver blood), 3 times a day, 1 gum each time (not exceeding 4 gums in 24 hours), 14 days as one cycle; ② External combined application: Liver-nourishing and vision-improving gel patches are applied to bilateral Jingming, Guangming, Ganshu, Zhangmen, Yinlingquan, and Qimen acupoints; Blood-activating and meridian-clearing gel patches are applied to Dazhui, bilateral Jianjing, and Houxi acupoints. Each application lasts 6-8 hours, once a day, 14 days as one cycle. Doctor's advice: Gradually reduce the dosage until abstinence from alcohol, rest during work breaks, cooperate with eye exercises and neck and shoulder stretching, avoid staying up late, and avoid raw, cold, spicy, and greasy foods.

[0448] Therapeutic effect observation:

[0449] Onset of action and symptom improvement: On the third day of treatment, a follow-up examination showed that dry mouth, bitter taste, dry eyes, and dizziness were reduced by about 30%, and stiff neck and shoulders and dull pain in the liver area were relieved by about 25%, indicating rapid onset of action.

[0450] Phase-by-phase efficacy: After one week of treatment, visual fatigue was significantly improved, and normal vision could be maintained for 1-2 hours. Neck and shoulder pain was reduced by 70%, limb numbness disappeared, dull pain in the liver area was relieved by 60%, and bitter taste in the mouth basically disappeared.

[0451] Endpoint efficacy: After 2 weeks of treatment (one cycle completed), all symptoms (dry mouth, bitter taste, dull pain in the liver area, dry eyes, blurred vision, neck and shoulder pain, dizziness, numbness in the limbs, etc.) disappeared completely, and the complexion became radiant. No discomfort was observed even after prolonged use of electronic devices. This was deemed a clinical cure.

[0452] Concurrent control group (routine intervention):

[0453] Mr. Chang, male, 31 years old, with the same occupation and syndrome type, had a 6-year history of alcohol consumption, with an average daily alcohol intake of approximately 60g. He received routine comprehensive intervention: oral administration of liver-protecting tablets and Xuefu Zhuyu pills, without strict restrictions on alcohol consumption.

[0454] Onset and efficacy: Mild symptom relief was observed on day 7 of the intervention, indicating a relatively slow onset of action. A follow-up examination two weeks after the intervention showed that dry eyes were relieved by approximately 40%, neck and shoulder pain by approximately 35%, and dry mouth, bitter taste, and dull pain in the liver area by only approximately 20%. Blurred vision, limb numbness, and mild discomfort in the liver area persisted. The intervention was deemed effective but did not meet the criteria for a cure.

[0455] Stability comparison: Due to the lack of control over alcohol consumption, symptoms fluctuated repeatedly, and the stability of the treatment effect was not as good as that of the treatment group.

[0456] in conclusion:

[0457] This case demonstrates that, for the complex syndrome of liver damage due to alcohol poisoning combined with blood stasis, the combination preparation of this invention, through the synergistic effect of internal and external application, not only clears alcohol toxins and nourishes the liver and improves eyesight, but also invigorates blood circulation and unblocks the meridians, resulting in faster onset of action (3 days vs. 7 days), more comprehensive and significant symptom improvement, achieving clinical cure within a 2-week cycle, and with stable efficacy. While the conventional methods in the control group were partially effective, they had a slow onset of action, a low cure rate, and the efficacy was difficult to consolidate under the influence of continued alcohol consumption. This highlights the advantages of the combination preparation of this invention in integrated treatment and source intervention (promoting alcohol cessation).

[0458] Case 2 (Damp-Heat Accumulation Syndrome): Mr. Wang, male, 69 years old. Chief complaint: Nausea, vomiting, dizziness, and chest tightness after drinking alcohol for 10 days, accompanied by headache after a hangover. The patient has a 31-year history of alcohol consumption, recently increasing to about 100g of alcohol daily due to increased social engagements, often on an empty stomach. He has taken oral hangover remedies, but the symptoms have not improved significantly and continue to recur. Symptoms: flushed face, foul breath, nausea, vomiting, dizziness, headache, chest tightness, palpitations after drinking alcohol, significant headache after a hangover, bitter taste in the mouth, dark yellow urine, and sticky stools. Red tongue with a yellow, greasy coating, and a slippery, rapid pulse. Diagnosis: Damp-Heat Accumulation Syndrome (internal accumulation of alcohol toxins, disturbing the middle jiao, disharmony of the spleen and stomach, and imbalance of qi and blood).

[0459] Treatment group (combination formulation of the present invention):

[0460] To clarify the independent efficacy of the preparation of this invention in relieving acute symptoms and clearing damp-heat, a single intervention regimen was adopted: ① Oral administration of sugar-free chewing gum (function: clearing damp-heat, detoxifying and harmonizing the middle jiao), 3 times a day, 1 gum each time (not exceeding 4 gums in 24 hours), for 14 days as one course of treatment; ② External application of heat-clearing and dampness-resolving gel patches, applied to the acupoints of Ganshu, Qimen, Taichong, Zhongwan, and Yinlingquan, for 6-8 hours each time, once a day, for 14 days as one course of treatment. Medical advice: Immediately reduce alcohol consumption, avoid drinking on an empty stomach, avoid barbecued and spicy foods, drink plenty of water, and maintain a regular sleep schedule.

[0461] Therapeutic effect observation:

[0462] Onset of action and rapid effect: On the second day of treatment, the dizziness and chest tightness were relieved, and the nausea and vomiting symptoms after drinking alcohol were reduced, showing rapid onset of action.

[0463] Phase-by-phase improvement: After one week of treatment, the hangover headache disappeared, the bitter taste in the mouth was relieved, bowel movements returned to normal, and only occasional mild nausea occurred after drinking.

[0464] End-of-cycle efficacy: After 2 weeks of treatment (1 course of treatment), all discomfort symptoms disappeared and there were no obvious adverse reactions after drinking alcohol.

[0465] Follow-up and consolidation: The patient was instructed to continue treatment for another course and strictly control alcohol consumption (<20g per day). A follow-up examination one month later showed clinical cure; a follow-up two months later showed a significant reduction in alcohol consumption, no further severe post-drinking discomfort, and overall good condition.

[0466] Control group (receiving routine symptomatic treatment):

[0467] A similar case, Mr. Xu, a 68-year-old male, had a 45-year history of alcohol consumption, averaging about 90g of alcohol per day. His symptoms were similar: flushed face, bitter taste in the mouth, nausea and dizziness after drinking, sticky stools, red tongue with a yellow, greasy coating, and a slippery, rapid pulse. He was diagnosed with the same type of damp-heat accumulation syndrome. The control group received routine symptomatic treatment: oral administration of Yin Zhi Huang granules, 3g each time, three times a day, along with general health education (suggesting reduced alcohol consumption and a light diet), without the use of external treatments such as acupoint application.

[0468] Onset of action and efficacy comparison: Symptoms began to slightly improve on the 3rd-4th day after intervention. A follow-up examination after 2 weeks of treatment showed that symptoms such as nausea and dizziness after drinking alcohol had decreased by about 50%, but the bitter taste in the mouth and greasy tongue coating had not improved significantly, and urine and stool remained yellowish-red and sticky. Recovery time after a hangover was still relatively long. The efficacy was deemed effective, but it did not meet the criteria for a complete cure with symptom elimination.

[0469] Stability and relapse rate: Due to the focus on post-treatment relief and lack of systematic management, patients' willingness and adherence to reducing alcohol consumption were low. A follow-up one month later revealed that the patient's symptoms recurred after another heavy drinking session, requiring intermittent medication for relief.

[0470] in conclusion:

[0471] This case comparison demonstrates that, for alcohol-induced toxicity due to damp-heat accumulation, the combined preparation of this invention, through internal administration for clearing and detoxification and external application for penetration, treats both internally and externally, rapidly relieving acute discomfort after drinking (such as nausea, dizziness, and headache), and simultaneously improving the core symptoms of damp-heat accumulation (such as bitter taste in the mouth, greasy tongue coating, and abnormal bowel movements). Clinical cure was achieved within a 2-week treatment course, and the intervention during treatment effectively promoted control of drinking behavior. Long-term follow-up showed stable efficacy. In contrast, conventional symptomatic treatment in the control group had a slower onset of action, limited improvement in damp-heat symptoms, and was difficult to cure. Furthermore, relapse was common without behavioral intervention support, highlighting the comprehensive advantages of this invention's approach in terms of syndrome targeting, comprehensive efficacy, and synergistic behavioral intervention.

[0472] 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 combination system formulation for preventing and treating the harms of alcohol consumption, characterized in that, This includes sugar-free chewing gum for oral administration and topical acupoint gel ointment (Babu plaster); the sugar-free chewing gum uses medicinal and edible ingredients as its core, with the following ingredient and weight ratio: 1-4 parts kudzu flower, 1-4 parts dried kudzu root, 1-4 parts immature bitter orange seeds, 1-4 parts acorus tatarinowii, 0.5-1 part vinegar-processed bupleurum, 0.5-1 part dried tangerine peel, 0.5-1 part poria cocos, 0.5-1 part dried jujube (pitted), and 0.1-0.5 parts rose; the topical acupoint gel ointment corresponds to five syndrome types: spleen deficiency with dampness, damp-heat accumulation, alcohol-induced liver damage, alcohol-induced mental disturbance, and alcohol-induced blood stasis. The ingredients for each syndrome type ointment are selected from medicinal and edible or commonly used Chinese herbs, and the matrix adopts a hydrophilic composite formula.

2. The combined system formulation according to claim 1, characterized in that, The three medicinal herbs in the sugar-free chewing gum can be replaced in equal amounts: 0.5-1 part by weight of dried tangerine peel can be replaced with any one of Buddha's hand, Cyperus rotundus, or Costus root; 0.5-1 part by weight of Poria cocos can be replaced with any one of Coix seed, Artemisia capillaris, Atractylodes macrocephala, Alisma plantago-aquatica, or Polyporus umbellatus; and 0.5-1 part by weight of dried jujube can be replaced with any one of licorice root, ginseng, Codonopsis pilosula, or Astragalus membranaceus.

3. The combined system formulation according to claim 1, characterized in that, The sugar-free chewing gum is a sugar-free formula that does not require water to take. It can be made into mouthwash, throat lozenges, granules, capsules, oral liquids, syrups, and various ready-to-drink health beverages.

4. The combined system formulation according to claim 1, characterized in that, The external acupoint gel ointment is based on the method of matching acupoints between the exterior and interior, combined with the methods of matching acupoints between the Yu and Mu points, the method of matching acupoints between the near and far points, the method of matching acupoints between the upper and lower points, and the principle of "specific functional acupoints and acupoints along the meridian". It can be made into rubber plasters, ointments, creams, gels, liniments, lotions, tinctures, oils, pastes, films, and sprays.

5. The combined system formulation according to claim 1, characterized in that, The raw materials for the spleen-strengthening and dampness-resolving gel ointment are: 2-4 parts Codonopsis pilosula, 2-4 parts Atractylodes macrocephala, 1-2 parts Poria cocos, 1-2 parts Dioscorea opposita, 1-2 parts Citrus reticulata peel, 1-2 parts Coix lacryma-jobi, and 0.1-0.5 parts Mentha haplocalyx; the base (based on 100g of ointment) is: 6-7g Carbomer 940, 4g Hydroxypropyl cellulose, 22-24g Glycerin, 12-14g Propylene glycol, 1.5g Azone, 2.5g Triethanolamine, 0.08g Benzalkonium bromide, and distilled water to make up to 100g (pH 6.5-7.0).

6. The combined system formulation according to claim 1, characterized in that, The raw materials and weight ratios of the heat-clearing and dampness-resolving, liver-nourishing and vision-improving, heart-calming and mind-soothing, and blood-activating and meridian-clearing gel ointments are as follows: (1) Heat-clearing and dampness-resolving type: Bupleurum 1-3 parts, Scutellaria baicalensis 1-2 parts, Artemisia capillaris 1-2 parts, Hovenia dulcis 1-3 parts, Coix lacryma-jobi 1-2 parts, Mentha haplocalyx 0.1-0.5 parts; (2) Liver-nourishing and vision-improving type: Lycium barbarum 1-3 parts, Ophiopogon japonicus 1-2 parts, Angelica sinensis 1-2 parts, Salvia miltiorrhiza 1-2 parts, Paeonia lactiflora 1-2 parts, Bupleurum 1 -2 parts, peppermint 0.1-0.5 parts; (3) Calming the mind and soothing the nerves type: Acorus tatarinowii 1-3 parts, Ziziphus jujuba var. spinosa 1-2 parts, Salvia miltiorrhiza 1-2 parts, Ophiopogon japonicus 1-2 parts, Gardenia jasminoides 0.5-1 parts, peppermint 0.1-0.5 parts, licorice 0.5-1 parts; (4) Blood-activating and collateral-dredging type: Salvia miltiorrhiza 2-4 parts, Angelica sinensis 1-2 parts, Ligusticum chuanxiong 1-2 parts, Paeonia lactiflora 1-2 parts, Lycium barbarum 1-2 parts, Ophiopogon japonicus 1-2 parts, peppermint 0.1-0.5 parts.

7. The combined system formulation according to claim 1, characterized in that, The base and weight ratio of the liver-nourishing and vision-improving, heart-calming and mind-soothing, and blood-activating and meridian-clearing gel ointments are as follows: (1) Liver-nourishing and vision-improving type for eye use (based on 100g of ointment): Carbomer 940 3-4g, hydroxypropyl cellulose 2g, glycerin 25-28g, propylene glycol 10-12g, azone 1g, triethanolamine 1.5g, benzalkonium bromide 0.05g, distilled water to make up to 100g; for the waist / back / lower limbs type, the base is the same as that of the spleen-strengthening and dampness-resolving type; (2) Heart-calming and mind-soothing type for head / chest / upper limbs (based on 100g of ointment): Carbomer 940 5g, hydroxypropyl cellulose 3g, glycerin 23-25g, propylene glycol 11-13g 1. Azone 1.2g, triethanolamine 2g, benzalkonium bromide 0.06g, distilled water to make up to 100g; Foot sole special (based on 100g ointment): Carbomer 9407g, hydroxypropyl cellulose 4g, glycerin 20g, propylene glycol 15g, azone 1.5g, triethanolamine 3g, benzalkonium bromide 0.08g, distilled water to make up to 100g; (3) Blood circulation and meridian clearing type (based on 100g ointment): Carbomer 9407-8g, hydroxypropyl cellulose 5g, glycerin 20-22g, propylene glycol 14-16g, azone 2g, triethanolamine 3g, benzalkonium bromide 0.1g, distilled water to make up to 100g (containing appropriate amount of lanolin).

8. A method for preparing a combined system formulation according to any one of claims 1-7, characterized in that, This includes the preparation of sugar-free chewing gum and the preparation of topical acupoint gel ointment; the core process of preparing the sugar-free chewing gum involves a temperature ≤60℃, employing low-temperature extraction and reduced-pressure concentration processes, with rose petals added separately after crushing; the topical gel ointment adopts a modular design, achieving the production of five types of ointments by replacing active ingredients, including active ingredient preparation, universal gel matrix preparation, ointment formulation and defoaming, coating and molding steps.

9. A method of using a combination system formulation according to any one of claims 1-7, characterized in that, Suitable for all drinking scenarios and daily maintenance: Chew one piece of sugar-free gum and apply the corresponding plaster 30 minutes before drinking; immediately after drinking, chew one or two pieces of sugar-free gum and apply the corresponding plaster.

10. The method of use according to claim 9, characterized in that, For long-term treatment, chew one sugar-free gum daily or every other day and apply the corresponding ointment 2-3 times a week. One treatment cycle is 14-28 days.

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