External traditional Chinese medicine composition for treating functional abdominal distension caused by deficiency-cold in spleen and stomach, preparation and application of external traditional Chinese medicine composition

Abstract

The invention discloses an external traditional Chinese medicine composition for treating spleen and stomach deficiency cold type functional abdominal distension, a preparation and application thereof. The traditional Chinese medicine composition comprises the following active ingredient raw materials in parts by weight: monarch drugs: 6-10 parts of rhizoma zingiberis and 8-12 parts of clove; ministerial drugs: 8-12 parts of pepper, 8-12 parts of fennel and 8-12 parts of folium artemisiae argyi; adjuvant drugs: 4-8 parts of rhizoma atractylodis and 4-8 parts of agilawood koji; and a conductant drug: 30-40 parts of magnetite. Crushing the medicinal materials into coarse particles, filling the coarse particles into a gauze bag to prepare a hot compress bag, and heating and ironing the Zhongwan acupoint; the traditional Chinese medicine composition is developed on the basis of the external treatment theory of traditional Chinese medicine, is scientific and reasonable in formula, simple in preparation process, simple and convenient to operate and safe, and has the curative effect of improving spleen and stomach deficiency-cold type functional abdominal distension.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and more specifically, to a topical traditional Chinese medicine composition, preparation, and application for treating functional abdominal distension due to spleen and stomach deficiency and cold. Background Technology

[0002] Functional bloating is a common functional gastrointestinal disorder (FGID) defined by the Rome IV criteria. It is characterized by recurrent episodes of abdominal distension or bloating, without evidence of organic disease. Global epidemiological studies show that the prevalence of functional bloating in the general population is approximately 16%–30%, with a significantly higher prevalence in women than men, and an increasing trend among middle-aged and elderly individuals. In China, based on multiple community and outpatient surveys, the overall prevalence of functional bloating is approximately 20%–25%, making it one of the significant chronic diseases affecting residents' quality of life.

[0003] In the theoretical system of Traditional Chinese Medicine (TCM), functional abdominal distension is mostly classified under the categories of "epigastric fullness" and "abdominal distension." Clinical observation and syndrome differentiation studies have shown that spleen and stomach deficiency-cold syndrome is one of the main TCM syndrome types of functional abdominal distension. A multicenter syndrome analysis of 1,200 Chinese patients with functional abdominal distension showed that spleen and stomach deficiency-cold syndrome accounted for 35%–40%, with an even higher proportion in elderly patients over 60 years of age. Common manifestations include: cold distension in the epigastrium and abdomen, preference for warmth and pressure, aggravation by cold, poor appetite, loose stools, fatigue, pale tongue with white coating, and weak pulse. Its core pathogenesis is spleen yang deficiency, impaired transportation and transformation, internal generation of cold and dampness, stagnation of qi, and failure of turbid yin to descend, belonging to a syndrome of deficiency in the root and excess in the branch.

[0004] Currently, the treatment for abdominal distension due to spleen and stomach deficiency and cold is still mainly based on oral Chinese herbal decoctions or prepared Chinese medicines, such as Lizhong Decoction, Fuzi Lizhong Pill, and Xiangsha Liujunzi Decoction. Although oral therapy has certain advantages in overall conditioning, it also has problems such as slow onset of action, gastrointestinal irritation, strong first-pass effect, and poor compliance in elderly patients. In particular, for elderly people with gastric mucosal lesions, difficulty swallowing, or multiple medications, the risks and inconvenience of oral administration are significantly increased.

[0005] In recent years, external treatments using traditional Chinese medicine have gained increasing attention in the management of chronic gastrointestinal diseases due to their advantages of being simple, convenient, effective, inexpensive, and safe. Among them, hot compress therapy (also known as hot compress or hot pack) involves applying heated Chinese herbs that have the functions of warming, dispersing cold, promoting qi circulation, and relieving pain to acupoints such as Shenque and Zhongwan. The combined effect of heat and the herbs promotes local blood circulation and warms the yang qi of the middle jiao, thereby alleviating abdominal distension symptoms. However, existing commercially available or literature-reported hot compress formulas mostly focus on simple warming and dispersing or promoting blood circulation and relieving pain (such as using herbs like mugwort, safflower, cinnamon twig, and chuanxiong), lacking a systematic combination of herbs specifically addressing the pathogenesis of abdominal distension due to spleen and stomach deficiency and cold, characterized by "deficiency in the root and excess in the branch, and interference between clear and turbid qi." In particular, they neglect the key pathological link described in the *Huangdi Neijing* as "turbid qi in the upper part of the body causes abdominal distension"—that is, how to effectively guide the stagnant qi in the middle jiao downwards and restore the spleen and stomach's ascending and descending function.

[0006] In addition, traditional external treatment formulas often do not fully consider the transdermal properties of drugs, skin safety, and long-term tolerance. Some contain irritating ingredients (such as high concentrations of white mustard seed and raw pinellia), which can easily cause skin burns, blisters, or allergic reactions, thus limiting their promotion and application in home care and long-term chronic disease management.

[0007] It is worth noting that magnetite, as a traditional sedative, has always been used internally to calm the liver and subdue yang, and to guide qi back to the kidneys. There are no reports of it being used externally in hot compresses to "guide qi downward" to treat abdominal distension.

[0008] Therefore, given the large patient population suffering from abdominal distension due to spleen and stomach deficiency and their urgent need for safe, convenient, and effective intervention methods, there is a pressing need for a scientifically formulated, highly safe, and effective external herbal hot compress that combines warming and invigorating the spleen, promoting qi circulation and resolving dampness, and guiding qi downwards. This would compensate for the shortcomings of existing technologies in chronic disease management and home rehabilitation. This invention is proposed within this clinical and public health context and possesses clear application prospects and technological innovation value. Summary of the Invention

[0009] This invention addresses the shortcomings of existing technologies by incorporating magnets into a hot compress. Based on the traditional Chinese medicine theory of "ascending, descending, exiting, and entering" of Qi and the physical properties of external treatments that "like attracts like, and the heavier tends to descend." The aim is to utilize the magnet's heavy and sinking properties to synergize with warming and Qi-regulating herbs, achieving a dual effect of "warming and invigorating spleen Yang to support the body's resistance and guiding Qi downward to dispel pathogens." This invention provides a topical Chinese medicine composition, preparation, and its application for treating functional abdominal distension due to spleen and stomach deficiency and cold.

[0010] To achieve the above objectives, the present invention adopts the following technical solution: In a first aspect, the present invention provides a topical Chinese medicine composition for treating functional abdominal distension due to spleen and stomach deficiency and cold, which is composed of the following raw materials in parts by weight: 6-10 parts dried ginger, 8-12 parts cloves, 8-12 parts Sichuan pepper, 8-12 parts fennel, 8-12 parts mugwort, 4-8 parts Atractylodes lancea, 4-8 parts agarwood, and 30-40 parts raw magnetite.

[0011] Furthermore, the composition of the raw materials, by weight: Secondly, the present invention provides a method for preparing the aforementioned external application traditional Chinese medicine composition, comprising the following steps: (1) Weigh out the following amounts of dried ginger, cloves, Sichuan pepper, fennel, mugwort, atractylodes, and agarwood powder, and put them into a Chinese medicine powder grinder to grind them into coarse particles. (2) Weigh out the raw magnetite by weight, put it into the Chinese medicine pulverizer, and pulverize it into coarse particles; (3) Mix all raw materials after passing them through a 20-40 mesh sieve.

[0012] Thirdly, the present invention provides a hot compress preparation comprising the above-mentioned topical Chinese medicine composition.

[0013] Fourthly, the present invention provides the application of the above-mentioned external Chinese medicine composition in the preparation of a medicine for hot compress treatment of functional abdominal distension of spleen and stomach deficiency-cold type.

[0014] Furthermore, the hot compress method specifically involves: raising the temperature of the medicine to 45-50°C, placing it on the Zhongwan acupoint, and applying the hot compress for 20-30 minutes.

[0015] Composition: 6-10 parts dried ginger, 8-12 parts cloves, 8-12 parts Sichuan pepper, 8-12 parts fennel seeds, 8-12 parts mugwort leaves, 4-8 parts Atractylodes lancea, 4-8 parts agarwood malt, 30-40 parts magnetite.

[0016] The principle of the formulation design of this invention: I. The Influence of Usage Characteristics on Efficacy 1. External application + hot compress = gentle and penetrating treatment The drug is not absorbed through the gastrointestinal tract, but rather exerts its effects through the skin, meridians, and acupoints.

[0017] Heating can enhance the penetration of medicine, dilate local blood vessels, and promote the circulation of qi and blood, which is in line with the idea in "Li Yue Pian Wen" that "the principle of external treatment is the same as the principle of internal treatment, and the medicine for external treatment is the same as the medicine for internal treatment".

[0018] 2. The dosage form is a coarse-grained cloth bag for hot compress. The drug should have the characteristics of being aromatic and penetrating, pungent and warm in nature, and easily volatile and transdermal.

[0019] The effects of heavy mineral medicines (such as magnetite) when applied externally differ from those when taken internally—their "heavy and sinking" properties are transformed into physical pressure + heat conduction + magnetic field effect (traditionally, it is believed that magnetite has the function of "guiding qi downwards," and external application can use its heavy and sinking force to help qi sink down).

[0020] II. Analysis of the prescription: Based on the principles of principal, assistant, adjuvant, and guide herbs in external application and hot compress. Chief ingredient: Dried ginger + cloves Dried ginger: pungent and hot, it specifically targets the spleen and stomach, greatly tonifying spleen yang and dispelling deep-seated cold and dampness in the middle jiao (middle burner). It is a key medicine for treating spleen and stomach deficiency and cold. When used externally, it can warm and unblock the middle jiao, stimulating the spleen's digestive function—a fundamental remedy.

[0021] Clove: pungent and warm, it warms the stomach and relieves nausea, dispels cold and relieves pain, especially good at treating "stomach cold and hiccups, cold distension in the epigastrium and abdomen". Its aroma is strong and its penetrating power is strong - it is the king of symptomatic treatment (cold stagnation and qi reversal).

[0022] Both are principal herbs; one warms the spleen yang (dried ginger), and the other relieves stomach upset (clove). They work synergistically, addressing both the root cause and the symptoms, which aligns with the core pathogenesis of "abdominal distension due to deficiency and cold."

[0023] Ingredients: Sichuan pepper + fennel seeds + mugwort Sichuan pepper: It is pungent and warm, and can relieve pain, kill parasites and relieve itching. When used externally, it can penetrate deep into the skin and enhance the local warming effect, and help dried ginger warm the spleen. Fennel: It is pungent and warm, regulates qi and stomach, dispels cold and relieves pain. It is good at treating "cold hernia abdominal pain and abdominal distension". It works with cloves to promote qi circulation and relieve bloating. Artemisia argyi: It is pungent and warm, warms the meridians and dispels cold, penetrates deep into the body, and is an important medicine for external treatment. It can increase heat conduction and reduce the irritation of other medicines, and protect the skin from burns.

[0024] The three ingredients work together to enhance the effects of "warming the middle, regulating qi, and penetrating the meridians," providing strong support for the principal ingredient and representing a typical assistant ingredient.

[0025] Adjuvant herbs: Atractylodes lancea + Agarwood Fragrance Atractylodes lancea: bitter, pungent, and warm in nature; it dries dampness, strengthens the spleen, and promotes the ascending of clear qi and descending of turbid qi. It is used to address the concurrent symptoms of "spleen deficiency leading to dampness, and dampness obstructing the flow of qi," preventing the retention of dampness and turbidity due to the use of purely warming and drying herbs; its aroma also aids in penetrating the skin.

[0026] Agarwood Fermentation: A fermented product of agarwood, it is warm in nature, promotes qi circulation and relieves pain, warms the middle jiao and harmonizes the stomach, and its medicinal properties are milder than those of agarwood, making it suitable for external use. It assists fennel and cloves in promoting qi circulation, while preventing excessive warmth and dryness.

[0027] Both herbs work together to resolve dampness and regulate qi, addressing both the concurrent symptoms (dampness obstruction) and harmonizing the pungent and drying properties of other herbs, thus serving as adjuvant herbs.

[0028] If the patient does not show signs of dampness (such as a thin white tongue coating rather than a thick, greasy one), the dosage of Atractylodes lancea can be reduced.

[0029] Used medicine: Magnetite Traditionally, internal use is used to suppress and calm the yang, but here it is used externally to take advantage of its physical property of "heavy weight sinking". It is applied to the Shenque / Zhongwan acupoint to guide the stagnant qi in the middle jiao downward and resolve the key issue of "turbid qi causing bloating when it is in the upper part of the body".

[0030] Although it is not a traditional "guiding medicine", it plays a role in the direction regulation of Qi flow in this formula, similar to a "medicinal guide" or "functional guide".

[0031] Therefore, the use of magnetite as an adjuvant in this formula reflects technological innovation—using external treatment to "guide qi downwards".

[0032] III. Summary of Fangyi This formula, based on the principles of warming and invigorating spleen yang and promoting qi circulation to descend turbidity, targets the pathogenesis of functional abdominal distension due to spleen and stomach deficiency and cold, characterized by "deficiency in the root and excess in the branch, with clear and turbid substances interfering with each other." It cleverly combines: dried ginger and cloves as the chief ingredients to warm the middle jiao, dispel cold, and support spleen yang; Sichuan pepper, fennel, and mugwort as the assistant ingredients to enhance warming, qi circulation, and penetration into the skin; Atractylodes lancea and agarwood as adjuvant ingredients to dry dampness, harmonize the stomach, and regulate the qi mechanism of the middle jiao; and innovatively, magnetite is introduced as the guiding ingredient, utilizing its heavy and descending properties to guide stagnant turbid qi downwards and restore the spleen and stomach's ascending and descending function. The entire formula is warm without being drying, and its effects are gentle without being harsh, addressing both the root cause and the symptoms. It aligns with the principles of "simplicity, convenience, effectiveness, and safety" in external treatment, providing a safe and effective non-oral intervention for treating functional abdominal distension due to spleen and stomach deficiency and cold.

[0033] Analysis of single herbs in the formula of this invention: Clove, pungent in taste and warm in nature, enters the spleen, stomach, and kidney meridians. It has the functions of warming the middle jiao and relieving nausea, dispelling cold and relieving pain, and warming the kidneys and assisting yang. The *Compendium of Materia Medica* states, "Clove treats stomach cold and vomiting, abdominal masses and abdominal distension, and treats kidney qi stagnation." The *Corrected Materia Medica* states, "Clove warms the middle jiao and invigorates qi, warms the spleen and stomach, and stops cholera-like bloating." It mainly contains eugenol, which has significant anti-inflammatory, analgesic, antibacterial, and gastrointestinal motility-promoting effects; it is highly volatile, aromatic, and has excellent transdermal properties, making it suitable for hot compress therapy. It is a key herb for warming the stomach and dispelling cold, relieving nausea and bloating, and is one of the principal herbs in this formula.

[0034] Dried ginger, pungent and hot in nature, enters the spleen, stomach, heart, and lung meridians. It can warm the middle jiao (spleen and stomach), dispel cold, restore yang, unblock the meridians, and warm the lungs to resolve phlegm. The *Shennong Bencao Jing* states, "It treats chest fullness, cough, shortness of breath, warms the middle jiao, stops bleeding, promotes sweating, and dispels wind-dampness." The *Ben Cao Qiu Zhen* states, "Dried ginger is extremely hot and non-toxic, it is stable and does not disperse, specifically entering the spleen and stomach to dispel deep-seated cold." It contains gingerols (shogaols), which have anti-inflammatory, antioxidant, and gastrointestinal motility-promoting effects. It is the core herb in this formula for warming and invigorating spleen yang, directly targeting the root cause of "spleen and stomach deficiency and cold."

[0035] Sichuan pepper, pungent and warm in nature, is slightly toxic and enters the spleen, stomach, and kidney meridians. It can warm the middle jiao (digestive system) to relieve pain, kill parasites, and relieve itching. The Compendium of Materia Medica states, "Sichuan pepper is a pure yang substance, entering the lung, spleen, and kidney meridians. It can dispel cold and dampness, warm the middle jiao, and regulate qi." It contains volatile oils (limonene, linalool, etc.) and alkaloids, possessing local irritant, analgesic, anti-inflammatory, and blood circulation-promoting effects. When used externally, it has a strong warming effect, good transdermal penetration, and works synergistically with dried ginger to enhance the warming effect on spleen yang.

[0036] Fennel seeds are pungent and warm in nature; they enter the liver, kidney, spleen, and stomach meridians. They can dispel cold, relieve pain, regulate qi, and harmonize the stomach. The Compendium of Materia Medica states, "Fennel is a warming and qi-regulating herb, treating lower abdominal coldness, hernia, and abdominal distension." Because it contains anethole, it has antispasmodic effects, promotes bile secretion, and regulates intestinal smooth muscle; externally, it can relieve intestinal bloating and uterine spasms, and is often used in abdominal heat packs.

[0037] Artemisia argyi leaves are pungent and bitter in taste, and warm in nature; they enter the liver, spleen, and kidney meridians. They can warm the meridians and stop bleeding, dispel cold and relieve pain, and are used externally to dispel dampness and relieve itching. The *Compendium of Materia Medica* states, "When ingested, artemisia argyi leaves travel through the three yin meridians and expel all cold and dampness… When used externally, they can treat a hundred diseases." The *Li Yue Pian Wen* states, "Applying artemisia argyi leaves externally can unblock the twelve meridians, regulate qi and blood, and expel cold and dampness." Containing volatile oils such as eucalyptol and thujone, they have anti-inflammatory, analgesic, and local blood circulation-promoting effects; they are one of the most commonly used drugs in external treatments; when applied as a hot compress, they release infrared radiation, enhancing heat conduction efficiency.

[0038] Atractylodes lancea, pungent and bitter in taste, warm in nature; enters the spleen, stomach, and liver meridians. It has the effects of drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight. *Pharmacopoeia of Herbs* states: "Atractylodes lancea is pungent and mainly disperses, warm and mainly dries, specifically entering the spleen and stomach, making it an essential medicine for removing dampness and strengthening the spleen." *Correct Interpretation of Materia Medica* states: "Atractylodes lancea is aromatic and dispels foulness, ascends clear qi and descends turbid qi, treating abdominal distension caused by dampness obstructing the middle jiao." Its "ascending clear qi and descending turbid qi" effect helps restore the ascending and descending qi mechanism of the spleen and stomach, making it a key adjuvant medicine for abdominal distension caused by spleen deficiency combined with dampness and turbidity.

[0039] Agarwood fermentation has a pungent, bitter, and warm nature; it enters the spleen, stomach, and kidney meridians. It can regulate qi, warm the middle jiao, relieve pain and vomiting, and soothe asthma. The *Ben Cao Tong Xuan* states, "Agarwood is warm but not drying, it moves without draining, it supports the spleen and promotes healthy circulation." After fermentation, it releases aromatic components more easily, regulating gastrointestinal motility, relieving anxiety, and improving microcirculation. As a fermented product, it has a rich aroma and mild medicinal properties. When used externally, it can aid in the transdermal absorption of other medicines and guide their downward flow, possessing both "qi-regulating" and "stagnation-relieving" effects.

[0040] Magnetite, salty in taste and cold in nature; enters the liver and kidney meridians. Traditional effects (internal use): calms the liver and subdues yang, improves hearing and vision, and relieves asthma. Its main component is Fe3O4, which has strong heat storage capacity, high specific heat capacity, and can generate a weak static magnetic field; local heat application can prolong the heat retention time, and physical pressure combined with the thermal effect promotes intestinal peristalsis. This formula innovatively uses a large dose of raw magnetite for external application as an adjuvant, taking advantage of its "heavy and sinking" nature, which, driven by heat, creates a "downward pulling" effect, guiding qi downwards, aligning with the pathogenesis of "abdominal distension caused by turbid qi rising upwards"; at the same time, it differs from its traditional internal effects of calming the liver and subduing yang, and relieving asthma by innovating its external application effects of heavy sedation and guiding qi downwards, which is the key technological innovation of this invention.

[0041] The beneficial effects of this invention are: 1. The traditional Chinese medicine composition of the present invention effectively improves functional abdominal distension caused by spleen and stomach deficiency and cold, has a rapid onset of action, is simple to operate, and has good safety.

[0042] 2. In this invention, dried ginger and cloves are the principal ingredients, directly entering the middle jiao (middle burner) to warm and invigorate spleen yang, dispel rebellious qi and cold, thus addressing the root cause of "spleen yang deficiency." Sichuan pepper, fennel, and mugwort are used as assistant ingredients to synergistically enhance warming, qi-regulating, and penetrating effects, quickly relieving the symptoms of "qi stagnation." Atractylodes lancea is used to dry dampness and strengthen the spleen, while agarwood is used to regulate qi and harmonize the stomach, addressing the concurrent symptoms of "internal obstruction by cold and dampness," and harmonizing the pungent and drying properties of the other herbs. A particularly innovative aspect is the introduction of a large dose of magnetite as the guiding ingredient. Utilizing its "heavy and sinking" physical property, it is applied externally as a hot compress to create downward traction potential energy, effectively guiding the stagnant turbid qi in the middle jiao downwards, precisely aligning with the pathogenesis theory in the *Neijing* (Inner Canon of Medicine) that "turbid qi in the upper part of the body causes abdominal distension."

[0043] 3. This invention uses external hot compress as the route of drug administration, avoiding the first-pass effect and gastrointestinal irritation of oral drugs, so that the medicine can directly reach the disease site and achieve multiple effects of "warming and invigorating the spleen yang to treat the root cause, promoting qi and clearing turbidity to treat the symptoms, and guiding qi downward to restore normalcy". Thus, while improving abdominal distension, it simultaneously solves a series of deficiency and cold syndromes such as fatigue, poor appetite, and loose stools, and effectively prevents recurrence. Attached Figure Description

[0044] The present invention will be further described below with reference to the accompanying drawings and embodiments; Figure 1 The graph shows the comparison of abdominal distension scores before and after treatment in the experimental group and the control group. **P<0.01.

[0045] Figure 2 The graph shows the comparison of fatigue scores before and after treatment in the experimental group and the control group. **P<0.01.

[0046] Figure 3 The graph shows the comparison of the appetite scores before and after treatment in the experimental group and the control group. **P<0.01.

[0047] Figure 4 The graph shows the comparison of stool loosening scores before and after treatment in the experimental group and the control group. **P<0.01.

[0048] Figure 5 The graph shows the comparison of quality of life scores before and after treatment in the experimental group and the control group. **P<0.01. Detailed Implementation

[0049] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0050] The traditional Chinese medicine composition used in this embodiment of the invention is as follows: 6 parts dried ginger, 9 parts cloves, 9 parts Sichuan pepper, 9 parts fennel, 9 parts mugwort, 6 parts Atractylodes lancea, 6 parts agarwood malt, and 30 parts raw magnetite.

[0051] Example 1: Research Data and Methods (I) Research Data 1. Research Subjects The study participants were all patients who visited Zhejiang Provincial Tongde Hospital between January 2025 and December 2025 and were diagnosed with functional abdominal distension of spleen and stomach deficiency-cold type.

[0052] 2. Western Medicine Diagnostic Criteria Repeated sensation of abdominal bloating or visible abdominal distension; Symptoms have persisted for at least 6 months, with an average of ≥1 day of onset per week in the past 3 months; It does not meet the diagnostic criteria for other functional gastrointestinal disorders (such as irritable bowel syndrome, functional dyspepsia, etc.); Organic diseases (such as tumors, intestinal obstruction, ascites, hypothyroidism, celiac disease, etc.) are ruled out through clinical evaluation, laboratory tests, or imaging examinations.

[0053] 3. Traditional Chinese Medicine Diagnostic Criteria for Spleen and Stomach Deficiency with Cold According to the "Expert Consensus on the Diagnosis and Treatment of Functional Abdominal Distension with Traditional Chinese Medicine (2023)" and the "Expert Consensus on the Diagnosis and Treatment of Abdominal Distension with Traditional Chinese Medicine (2023)," the TCM diagnostic criteria are as follows: Main symptoms: 1. Abdominal distension, aggravated by cold; 2. Relieved by warmth or massage.

[0054] Secondary symptoms: 1. Fatigue and weakness; 2. Cold extremities; 3. Sallow complexion; 4. Poor appetite and reduced food intake; 5. Frequent urination with clear urine; 6. Loose stools.

[0055] Tongue and pulse: The tongue is pale and swollen with teeth marks, and the pulse is deep; A diagnosis can be made based on two primary symptoms, two secondary symptoms, and by referring to the tongue and pulse.

[0056] 4. Inclusion criteria Those who meet the Western medical diagnostic criteria for functional abdominal distension; Those who meet the diagnostic criteria for spleen and stomach deficiency-cold in Traditional Chinese Medicine; Age 20-70 years old; No allergy to the medication used; Informed consent and active participation.

[0057] 5. Exclusion Criteria Abnormal function of vital organs; Abdominal pain and bloating caused by other reasons; They have cognitive impairment and are unable to cooperate. Other situations that researchers determined did not meet the inclusion criteria. 6. Exclusion Criteria If adverse reactions occur during medication, the patient cannot continue to receive the treatment regimen studied in this study. If the condition worsens or other diseases develop after treatment, requiring the use of other medications, it will affect the evaluation of the treatment effect. Poor adherence; unable to receive treatment as required or complete efficacy assessments.

[0058] 7. Shedding Criteria Patients whose treatment course is less than half of the clinical observation period or whose observation records are incomplete; Patients who naturally shed their skin or were lost to follow-up.

[0059] Example 2 Research Methods 1. Sample size estimation This study is a randomized controlled trial, with the overall effective rate of the two groups as the primary outcome measure. The sample size was calculated using the following formula: The effective rate of the experimental group P I = 0.95, the effective rate of the control group P 2=0.75, n1=n2=n (i.e., experimental group: control group=1:1), take a two-tailed test α=0.05, 1-β=80%, =(r P 1+ P 2) / 2, Z1-α / 2=1.96, Z1-β=0.842 (the power of the test is calculated as 80%). Based on the sample size estimation formula, in accordance with the requirements of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", and considering the previous treatment history of subjects in the gastroenterology ward of our hospital, plus the expected maximum dropout rate of 10%, the final calculated n=55.

[0060] 2. Grouping method The subjects were randomly assigned to two groups using a random number table generated by SPSS 22.0 software: an experimental group of 55 subjects and a control group of 55 subjects.

[0061] 3. Treatment methods The control group received routine treatment: dietary adjustments, mosapride tablets, 5mg, 3 times / day (Lunan Better Pharmaceutical Co., Ltd., approval number: National Drug Approval Number H19990317), for a course of 2 weeks.

[0062] The experimental group received mosapride combined with traditional Chinese medicine hot compress therapy. Raw magnetite and the remaining medications were separately crushed into coarse particles, uniformly mixed, passed through a 20-mesh sieve, and placed in a 20 cm × 10 cm gauze bag. The bag was placed in a constant temperature incubator at 80℃ for 20 minutes, until the temperature of the bag reached 45℃. The bag was then placed on the Zhongwan acupoint and hot compressed for 30 minutes. The patient's condition was closely monitored during this period; if blisters or pain appeared, the hot compress should be discontinued. The treatment course was 2 weeks.

[0063] 4. Observation Indicators 4.1 Traditional Chinese Medicine Syndrome Scoring Based on the "Expert Consensus Opinion on Quantitative Standards for Symptoms of Spleen and Stomach Diseases (2017)," the primary symptom is abdominal distension, and the secondary symptoms are fatigue, poor appetite, and loose stools. According to the severity of symptoms, they are divided into none, mild, moderate, and severe. The primary symptom is scored as 0, 2, 4, and 6 points, and the secondary symptom is scored as 0, 1, 2, and 3 points. The higher the score, the more severe the symptoms.

[0064] The specific scoring criteria for abdominal distension are as follows: Severity of abdominal distension: 0 points for no symptoms; 2 points for symptoms that can be felt when at rest; 4 points for symptoms that persist but do not affect daily life and work; 6 points for symptoms that persist and affect daily life and work.

[0065] 4.2 Quality of life The patient-reported outcome (PRO) scale for diseases of the spleen and stomach in traditional Chinese medicine was used to evaluate the quality of life of the two groups, and the scores were directly proportional to the quality of life.

[0066] 4.3 Recurrence rate Patients were followed up for one month after treatment. Both groups of patients were followed up and the recurrence of abdominal distension was recorded. If a patient experienced recurrent abdominal distension or visible abdominal bloating for 3 days, and was clinically diagnosed as having functional abdominal distension, it was considered a recurrence.

[0067] 5. Evaluation Criteria 5.1 Criteria for Judging Therapeutic Effect The efficacy index was calculated using the nimodipine method: (pre-treatment score - post-treatment score) / pre-treatment score × 100%.

[0068] Clinical cure: The main symptoms and signs have disappeared or basically disappeared, and the efficacy index is ≥95%; Significantly effective: Major symptoms and signs show marked improvement, with 60% ≤ efficacy index < 95%; Effective: Major symptoms and signs show significant improvement; efficacy rate ≤ 30% < 60%; Ineffective: The main symptoms and signs show no significant improvement or even worsen, and the efficacy index is <30%.

[0069] 5.2 Safety Evaluation Standards Formulated with reference to the 2002 edition of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs": Grade I: Safe, no adverse reactions occurred during treatment; Category II: Relatively safe. If adverse reactions occur, no special treatment is required, and subsequent medication can be administered. Level III: Safety issues exist; certain adverse reactions occurred during the test. Subsequent procedures can proceed after appropriate measures are taken. test; Grade IV: Serious adverse reactions occur, requiring termination of the clinical trial.

[0070] 6. Statistical methods This study used SPSS 25.0 software to process statistical data. Chi-square tests were used for count data. Measurement data that conformed to an approximately normal distribution were expressed as mean (X) ± standard deviation (S) and analyzed using t-tests. Rank-sum tests were used for ordinal data. The statistical significance level was set at α = 0.05. P If P > 0.05, it is considered that there is no statistically significant difference between the tested groups; if P < 0.05, it is considered that there is a statistically significant difference between the tested groups.

[0071] Results of Example 3 (I) Case Completion Status This study included 110 patients, with 55 in the experimental group and 55 in the control group. During the study, 4 patients in the experimental group and 3 patients in the control group were excluded due to their inability to cooperate with treatment and difficulties in information collection. 2 patients in the control group withdrew automatically due to mediocre efficacy. A total of 101 patients completed the study. See Table 1 for details. Table 1. Case Completion Status (II) General Patient Information Two groups of people, based on gender, age, and surgical site, were... t The results of the test and chi-square test were both P > 0.05, indicating that there were no significant differences in general data between the two groups and they were comparable. See Table 2 for details.

[0072] Table 2. Comparison of general information between the two groups of patients (III) Clinical observation results 1. Improvement status of primary symptoms Before treatment, the abdominal distension score in the experimental group was 4.08±1.38, and in the control group it was 3.92±1.46. There was no significant difference between the two groups. P =0.576), indicating comparability; after treatment, the abdominal distension score in the experimental group was 1.18±1.28, while that in the control group was 2.04±1.54. Both groups showed a significant decrease in abdominal distension scores compared to before treatment, indicating that mosapride or mosapride combined with traditional Chinese medicine hot compress therapy can improve abdominal distension symptoms in patients with spleen and stomach deficiency-cold type functional abdominal distension; after treatment, the abdominal distension score in the experimental group was significantly lower than that in the control group ( P =0.003), indicating that the efficacy of mosapride combined with traditional Chinese medicine hot compress and poultice is superior to that of mosapride alone. See Table 3 for details. Figure 1 .

[0073] Table 3. Comparison of abdominal distension scores before and after treatment in the two groups of patients. 2. Improvement of secondary symptoms There were no statistically significant differences in the pre-treatment scores of fatigue, poor appetite, and loose stools between the experimental and control groups, indicating that they were comparable.

[0074] After treatment, the fatigue scores in the experimental group and the control group were 0.31±0.47 and 0.74±0.90, respectively, both significantly lower than the scores before treatment in the same group. This indicates that both groups can improve the fatigue symptoms of functional abdominal distension due to spleen and stomach deficiency and cold. Intergroup comparison revealed that the score in the experimental group after treatment was significantly lower than that in the control group. P The result was <0.01, indicating that the combination of mosapride and traditional Chinese medicine hot compress was more effective than mosapride alone in improving fatigue symptoms.

[0075] After treatment, the appetite deficit scores in the experimental group and the control group were 0.39±0.57 and 0.82±0.87, respectively, both significantly lower than the scores before treatment in the same group. This indicates that both groups can improve the appetite deficit symptoms of functional abdominal distension due to spleen and stomach deficiency and cold. Intergroup comparison revealed that the score in the experimental group after treatment was significantly lower than that in the control group. P <0.01), indicating that mosapride combined with traditional Chinese medicine hot compress is more effective than mosapride alone in improving symptoms of poor appetite.

[0076] After treatment, the stool loosening scores in the experimental group and the control group were 0.47±0.61 and 1.52±0.95, respectively. Compared with the scores before treatment in the same group, the score in the experimental group was significantly lower. P <0.01), while there was no statistically significant difference in the control group; intergroup comparison revealed that the score of the experimental group after treatment was significantly lower than that of the control group ( PThe result was <0.01, indicating that mosapride had no significant effect on improving loose stool symptoms, while the combination of mosapride with traditional Chinese medicine hot compresses significantly improved the symptoms. See Table 4 for details. Figure 2-4 .

[0077] Table 4. Comparison of fatigue, poor appetite, and loose stool symptom scores before and after treatment in the two groups. Note: Compared with the control group, a indicates P < 0.01; compared with the group before treatment, b indicates P < 0.01. 3. Improvement in lifestyle therapy Before treatment, the PRO scale scores of the experimental group and the control group were 57.10±6.98 and 56.54±6.67, respectively, with no statistically significant difference between the two groups, indicating comparability. After treatment, the scores of the two groups were 68.84±6.67 and 62.54±6.67, respectively, both significantly higher than before treatment. P <0.001 indicates that both groups can improve the quality of life of patients with functional abdominal distension due to spleen and stomach deficiency and cold; the intergroup comparison showed that the PRO scale score of the experimental group was significantly higher than that of the control group ( P <0.001), indicating that mosapride combined with traditional Chinese medicine hot compresses and poultices is more effective than mosapride alone in improving quality of life symptoms. Table 5 and Figure 5 .

[0078] Table 5. Comparison of PRO scale scores before and after treatment in the two groups of patients. 4. Overall Effectiveness The cure rate was 49.0% in the experimental group and 28.0% in the control group, showing a significant difference between the two groups. P =0.030); there was no statistically significant difference in efficacy and effectiveness between the two groups ( P >0.05); the total effective rate in the experimental group was 94.1%, which was significantly higher than that in the control group (78.0%), and the difference was statistically significant. P <0.05), indicating that both groups can effectively improve the symptoms of functional abdominal distension caused by spleen and stomach deficiency and cold. However, the combination of mosapride and traditional Chinese medicine hot compress is more effective than mosapride alone. See Table 6 for details.

[0079] Table 6. Comparison of overall efficacy between the two groups 5. Recurrence rate One month after treatment, 7 cases (13.7%) relapsed in the experimental group, while 18 cases (36.0%) relapsed in the control group. The relapse rate in the control group was significantly higher than that in the experimental group, and the difference between the two groups was statistically significant. P=0.013), indicating that mosapride combined with traditional Chinese medicine hot compress therapy can significantly reduce the recurrence rate of functional abdominal distension caused by spleen and stomach deficiency and cold, and the effect is better than mosapride alone, as detailed in Table 7.

[0080] Table 7. Comparison of recurrence rates between the two groups (iv) Safety evaluation During the study, no patients experienced significant adverse reactions. The patients' vital signs remained stable before and after treatment, and there were no significant abnormalities in blood routine, liver and kidney function, electrocardiogram, and other results, indicating that both treatment regimens were safe and reliable.

[0081] Analysis of Research Results in Example 4 (I) Comparative Analysis of Case Demographic Data This study included 110 patients with functional abdominal distension due to spleen and stomach deficiency-cold. After randomization, there were no statistically significant differences between the experimental group and the control group in terms of gender composition (P=0.774) and age distribution (P=0.608). This indicates that the two groups are well comparable in terms of baseline demographic characteristics, effectively eliminating confounding bias caused by population differences in the final efficacy evaluation, and laying a solid foundation for the subsequent objective and fair evaluation of the clinical efficacy of the herbal hot compress pack of this invention.

[0082] (II) Comparative Analysis of Therapeutic Effects The results showed that the combination of mosapride and the herbal hot compress pack of the present invention (experimental group) was significantly better than the use of mosapride alone (control group) in multiple dimensions.

[0083] Improvement of core symptoms: After treatment, the abdominal distension score of the experimental group (1.18±1.28) was significantly lower than that of the control group (2.04±1.54). P =0.003), proving that the present invention can more effectively relieve the most troublesome abdominal bloating in patients.

[0084] Overall improvement in TCM syndromes: Regarding secondary symptoms, the experimental group showed better improvement in fatigue, loss of appetite, and poor food intake than the control group. P <0.01). Crucially, the control group showed no significant improvement in loose stool symptoms, while the experimental group showed significant improvement in these symptoms. P <0.01), which fully demonstrates the overall regulatory advantages of this invention in warming the spleen and tonifying the spleen, drying dampness and stopping diarrhea, targeting the core pathogenesis of "spleen and stomach deficiency and cold".

[0085] Overall efficacy and recurrence rate: The total effective rate in the experimental group was as high as 94.1%, significantly higher than the 78.0% in the control group (P<0.05), and the cure rate (49.0% vs 28.0%) was also higher. During the one-month follow-up, the recurrence rate in the experimental group (13.7%) was much lower than that in the control group (36.0%). P =0.013). The above data collectively demonstrate that this invention not only has a rapid onset of action and good therapeutic effect, but also consolidates the therapeutic effect and reduces the risk of disease recurrence.

[0086] Improved quality of life: The improvement in quality of life (PRO scale score) of patients in the experimental group was significantly greater than that in the control group (P<0.001), indicating that the present invention can more comprehensively improve the physical and mental health of patients and improve their quality of daily life.

[0087] (III) Comparative Analysis of Safety Throughout the study, no serious adverse reactions related to treatment were reported by any of the participants. Vital signs, complete blood counts, liver and kidney function, and electrocardiograms monitored before and after the trial were all normal. This indicates that, under standardized operating procedures (such as controlling the temperature of the herbal compress at 45–50°C and closely observing skin reactions), the traditional Chinese medicine hot compress therapy described in this invention has extremely high safety and good tolerability. Its external treatment characteristics avoid the potential burden on the liver and kidneys and gastrointestinal discomfort caused by oral medications, making it particularly suitable for elderly individuals, those with difficulty swallowing, or those taking multiple medications. It provides a safe and reliable new non-pharmacological intervention option for patients with functional abdominal distension due to spleen and stomach deficiency.

[0088] The foregoing description of embodiments of the present invention, through which those skilled in the art are able to implement or use the present invention, will be readily apparent to those skilled in the art. Various modifications to these embodiments will be readily apparent to those skilled in the art. The general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novelty disclosed herein.

Claims

1. A traditional Chinese medicine composition for external use for treating functional abdominal distension of spleen-stomach deficiency cold, characterized in that, By the following raw materials by weight parts: dried ginger 6-10 parts, clove 8-12 parts, pepper 8-12 parts, fennel 8-12 parts, eucalyptus 8-12 parts, atractylodes 4-8 parts, eaglewood 4-8 parts, raw magnetite 30-40 parts.

2. An external use traditional Chinese medicine composition for treating functional abdominal distension of spleen-stomach deficiency cold, characterized in that, By the following raw materials by weight parts: dried ginger 6 parts, clove 9 parts, pepper 9 parts, fennel 9 parts, eucalyptus 9 parts, atractylodes 6 parts, eaglewood 6 parts, raw magnetite 30 parts.

3. The preparation method of the external traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The method comprises the following steps: (1) take the weight parts of dried ginger, clove, pepper, fennel, eucalyptus, atractylodes, eaglewood, and put them into a traditional Chinese medicine powder machine to crush into coarse particles; (2) take the weight parts of raw magnetite and put them into a traditional Chinese medicine powder machine to crush into coarse particles; (3) mix all the raw materials after passing through a 20-40 mesh sieve.

4. A hot compress preparation, characterized in that, The external use traditional Chinese medicine composition of any one of claims 1-2.

5. The use of the external use traditional Chinese medicine composition of any one of claims 1-2 in the preparation of a medicament for hot compress treatment of functional abdominal distension of the type of deficiency of the spleen and stomach.

6. Use according to claim 5, characterized in that, The hot compress mode is specifically: after the medicament is raised to 45-50℃, it is placed on the middle of the abdomen and hot pressed for 20-30 min.

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