External use traditional Chinese medicine composition with the effects of moving qi to dredge bowels, regulating cold and heat and ascending clear and descending turbid, external use traditional Chinese medicine ointment, preparation method and application

Abstract

The application belongs to the technical field of traditional Chinese medicine, and particularly relates to an external traditional Chinese medicine composition with the effects of promoting qi circulation and dredging bowels, regulating cold and heat, ascending clear and descending turbid, an external traditional Chinese medicine ointment, a preparation method and application. The external traditional Chinese medicine composition is composed of the following raw medicinal materials: dried ginger, cassia twig, fried atractylodes, radix codonopsis, raw rhubarb, goldthread, immature orange fruit, magnolia officinalis, fried pinellia and licorice. The external traditional Chinese medicine composition has the effects of promoting qi circulation and dredging bowels, regulating cold and heat, ascending clear and descending turbid, and has a remarkable curative effect on treating chronic obstructive pulmonary disease combined with gastrointestinal dysfunction, so that the function of the patient's spleen and stomach is recovered, the clinical symptoms of the patient are effectively relieved, and the quality of life is improved, and there is no problem of the patient not being easy to tolerate and the gastrointestinal burden being aggravated.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a topical Chinese medicine composition, topical Chinese medicine ointment, preparation method and application that have the effects of regulating qi and bowel, balancing cold and heat and promoting the upward movement of clear qi and downward movement of turbid qi. Background Technology

[0002] Patients with COPD experience a decline in gastrointestinal function due to systemic inflammation, hypoxemia, respiratory acidosis, and gastrointestinal congestion. This leads to symptoms such as abdominal distension, loss of appetite, and incomplete bowel movements. Abdominal distension restricts diaphragmatic movement, further weakening respiratory muscles. These two factors exacerbate lung function, creating a vicious cycle where declining lung function and gastrointestinal dysfunction reinforce each other. Traditional Chinese medicine also believes that COPD patients often suffer from chronic illness and physical weakness, and long-term use of large amounts of medication, especially antibiotics, damages the spleen and stomach's digestive function. When the spleen and stomach's ascending and descending functions are impaired, clear and turbid substances mix, producing pathological products such as food stagnation and phlegm. This further obstructs the flow of qi and affects the spleen and stomach's function of ascending clear qi and descending turbid qi. Therefore, COPD is prone to gastrointestinal dysfunction, presenting with symptoms of deficiency and cold such as epigastric fullness, aggravated by cold, belching, poor appetite, shortness of breath, fatigue, aversion to cold, cold limbs, and loose stools. At the same time, it also manifests symptoms of excess and heat such as coughing up yellow phlegm, intestinal obstruction, dry mouth, and bitter taste.

[0003] Currently, Western medicine treatment for COPD complicated by gastrointestinal dysfunction often involves controlling COPD while using prokinetic drugs such as domperidone and metoclopramide. Both are dopamine receptor antagonists, and given that COPD patients often have comorbidities such as heart failure and arrhythmias, the use of these drugs carries the risk of inducing arrhythmias. Furthermore, COPD patients often have multiple complications and require multiple medications; oral medications have drawbacks such as poor patient tolerance and increased gastrointestinal burden.

[0004] In Traditional Chinese Medicine (TCM), there are currently TCM compositions specifically designed to treat Chronic Obstructive Pulmonary Disease (COPD). For example, patent document CN118948962A discloses a TCM composition for treating COPD, which includes: 5-15 parts of antelope horn or 50-150 parts of goat horn, 10-60 parts of Fritillaria cirrhosa, 15-60 parts of rhubarb, 7-30 parts of Scutellaria baicalensis, 7-30 parts of chlorite, 10-50 parts of gypsum, 5-20 parts of artificial bezoar, and 15-60 parts of licorice. This TCM composition has a certain therapeutic effect on COPD. There are also TCM compositions specifically targeting gastrointestinal dysfunction. For example, patent document CN107126490A discloses a TCM composition for preventing and treating gastrointestinal dysfunction, which consists of Codonopsis pilosula, Poria cocos, stir-fried Atractylodes macrocephala, Citrus reticulata peel, processed Pinellia ternata, raw licorice, raw rhubarb, Glauber's salt, Magnolia officinalis, and Citrus aurantium. This composition has a significant therapeutic effect on gastrointestinal dysfunction.

[0005] The above-mentioned Chinese herbal medicine combinations have certain therapeutic effects on COPD or gastrointestinal dysfunction alone, but their efficacy is insufficient for COPD combined with gastrointestinal dysfunction.

[0006] In view of the above, this application is hereby submitted. Summary of the Invention

[0007] In order to overcome the shortcomings of the prior art, this application proposes a topical Chinese medicine composition, a topical Chinese medicine ointment, a preparation method and application that can effectively prevent and / or treat COPD complicated with gastrointestinal dysfunction.

[0008] The first aspect of this application provides a topical Chinese medicine composition with the functions of regulating qi and bowel movement, balancing cold and heat, and promoting the ascending of clear qi and descending of turbid qi. The topical Chinese medicine composition is composed of the following raw materials: dried ginger, cinnamon twig, stir-fried atractylodes macrocephala, codonopsis pilosula, raw rhubarb, coptis chinensis, immature bitter orange, magnolia bark, processed pinellia ternata, and prepared licorice root.

[0009] The detailed pharmacological effects of the above-mentioned Chinese medicinal herbs are as follows:

[0010] Dried ginger: pungent in flavor and hot in nature. It enters the spleen, stomach, kidney, heart, and lung meridians. It has the effects of warming the middle jiao and dispelling cold, restoring yang and unblocking the meridians, and warming the lungs and resolving phlegm. It is mainly used to treat abdominal pain, vomiting, and diarrhea caused by spleen and stomach deficiency and cold; collapse of yang syndrome, cold extremities, and weak and almost imperceptible pulse; cough, asthma, cold limbs and back, and copious clear and thin phlegm caused by cold phlegm lurking in the lungs.

[0011] Cinnamon twig: pungent and sweet in taste, warm in nature. It enters the heart, lung, and bladder meridians. It has the effects of inducing sweating and relieving muscle tension, warming and unblocking the meridians, and assisting yang and qi transformation. It is mainly used to treat colds due to wind-cold, fever, headache, aversion to wind, and sweating; menstrual disorders, amenorrhea, dysmenorrhea, rheumatic pain, and shoulder and arm pain due to cold stagnation and blood stasis; phlegm retention and water retention syndromes; and palpitations and chest pain due to insufficient heart yang.

[0012] Stir-fried Atractylodes macrocephala: Sweet and bitter in taste, warm in nature. It enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is mainly used to treat poor appetite, loose stools, fatigue and weakness due to spleen and stomach weakness and poor digestion; edema and phlegm retention due to spleen deficiency and dampness; spontaneous sweating due to spleen qi deficiency and weak defensive qi; and fetal restlessness due to spleen deficiency and qi weakness.

[0013] Codonopsis pilosula: Sweet in taste and neutral in nature. It enters the spleen and lung meridians. It has the effects of purging and eliminating stagnation, clearing heat and purging fire, cooling blood and detoxifying, and removing blood stasis and promoting menstruation. It is mainly used to treat stagnation of heat, constipation, and diarrhea due to heat accumulation; high fever and delirium due to Yangming bowel obstruction; hematemesis and epistaxis due to blood heat; sores and burns due to heat toxins; amenorrhea, dysmenorrhea, and traumatic injuries due to blood stasis.

[0014] Raw rhubarb: Nature, flavor, and meridian tropism: Bitter in taste and cold in nature. It acts on the spleen, stomach, large intestine, liver, and pericardium meridians. It has the effects of purging and attacking accumulation, clearing heat and purging fire, cooling blood and detoxifying, removing blood stasis and dredging channels. It is mainly used to treat excess heat accumulation and stagnation, constipation, heat accumulation with fluid retention; high fever, delirium in Yangming fu syndrome; hematemesis and epistaxis due to blood heat running amok; heat-toxic ulcers, burns and scalds; amenorrhea, dysmenorrhea, and traumatic injuries caused by blood stasis blockage.

[0015] Coptis chinensis: Bitter in taste and cold in nature. It acts on the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying. It is mainly used to treat damp-heat obstruction and fullness, vomiting and acid regurgitation, diarrhea, dysentery; high fever and coma, restlessness and insomnia, mouth ulcers, red and swollen eyes, and carbuncles and sores.

[0016] Immature bitter orange: Nature, flavor, and meridian tropism: Bitter, pungent, and sour in taste, slightly cold in nature. It acts on the spleen and stomach meridians. It has the effects of breaking qi and reducing accumulation, resolving phlegm and dispelling stagnation. It is mainly used to treat gastrointestinal accumulation and stagnation, damp-heat diarrhea and dysentery; chest and hypochondriac pain due to qi stagnation; chest and epigastric fullness and oppression, phlegm-heat binding in the chest caused by phlegm turbidity blockage.

[0017] Magnolia officinalis: Nature, flavor, and meridian tropism: Bitter and pungent in taste, warm in nature. It acts on the spleen, stomach, lung, and large intestine meridians. It has the effects of drying dampness and resolving phlegm, lowering qi and relieving fullness. It is mainly used to treat dampness blocking the middle jiao, epigastric fullness and distension; cough and dyspnea due to phlegm retention; epigastric fullness and distension, belching, and constipation caused by qi stagnation.

[0018] Prepared Pinellia ternata: Nature, flavor, and meridian tropism: Pungent in taste, warm in nature. Toxic. It acts on the spleen, stomach, and lung meridians. It has the effects of drying dampness and resolving phlegm, lowering adverse qi and stopping vomiting, dissipating masses and resolving stagnation. It is mainly used to treat syndromes of damp phlegm and cold phlegm, cough with profuse phlegm, white and clear; various types of vomiting, especially those caused by phlegm retention or stomach cold; chest and epigastric stuffiness and oppression, globus hystericus caused by the combination of phlegm and heat.

[0019] Prepared licorice root: Nature, flavor, and meridian tropism: Sweet in taste, neutral in nature. It acts on the heart, lung, spleen, and stomach meridians. It has the effects of invigorating the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasm and pain, and harmonizing various herbs. It is mainly used to treat weakness of the spleen and stomach, lassitude and fatigue; heat-toxic ulcers, drug and food poisoning; cough and asthma; weakness of the spleen and stomach, spasmodic pain in the abdomen, and spasmodic pain in the limbs; harmonizing various herbs in a formula.

[0020] In summary, it can be seen that the external-use traditional Chinese medicine composition of this application also has sufficient theoretical support at the level of modern pharmacological research. The analysis of the formula of the external-use traditional Chinese medicine composition of this application is as follows:

[0021] Traditional Chinese medicine believes that the pathogenesis of chronic obstructive pulmonary disease (COPD) complicated with gastrointestinal dysfunction can be attributed to the combined effects of spleen and lung weakness, phlegm-dampness blockage, and qi stagnation. The core pathogenesis lies in deficiency of the lung and spleen qi, accompanied by phlegm-dampness blockage.

[0022] First, the lungs are the master of Qi, internally and externally related to the large intestine, governing respiration and regulating water metabolism. The *Suwen* (Plain Questions) chapter on cough states, "All five viscera and six bowels can cause cough, not just the lungs." Insufficient lung Qi weakens the body's defensive function, making it easier for external pathogens like cold and dampness to invade. Furthermore, impaired lung function leads to the internal generation of phlegm and dampness, resulting in airway obstruction, cough, and excessive phlegm. Simultaneously, the spleen is the foundation of acquired constitution, governing the transformation and transportation of food essence, and is a source of phlegm. The *Suwen* chapter on the spleen's function states, "The spleen disperses essence, which ascends to the lungs, regulating water metabolism." If the spleen Qi is deficient, the transformation and transportation of dampness will be abnormal, leading to internal retention of dampness, which easily aggravates lung disease.

[0023] Furthermore, spleen deficiency and stomach weakness lead to stagnation of Qi and impaired stomach function, manifesting as gastrointestinal dysfunction such as bloating, nausea, and loose stools. The *Medical Mirror of the Golden Chamber* states, "When the middle Qi is deficient, the spleen fails to ascend clear Qi, the stomach loses its harmony and descending function, and phlegm and dampness obstruct the flow," emphasizing that spleen and stomach dysfunction is a major root cause of phlegm and dampness formation. Prolonged retention of phlegm and dampness can further obstruct Qi flow, affecting the normal functioning of the lungs and spleen, creating a vicious cycle.

[0024] Patients with COPD complicated by gastrointestinal dysfunction often present with symptoms such as lung qi deficiency, phlegm-dampness obstruction, spleen and stomach dysfunction, and mixed cold and heat patterns. Treatment should follow the principles of warming yang and dispelling cold, resolving phlegm and relieving asthma, strengthening the spleen and replenishing qi, and clearing heat from the bowels. By regulating lung and spleen function through multiple pathways, symptoms can be alleviated and quality of life improved.

[0025] The topical Chinese medicine composition of this application uses "Huanglian Tang" as its formula. "Huanglian Tang" comes from the *Shanghan Lun* (Treatise on Cold Damage), which states: "In cases of cold damage, with heat in the chest, pathogenic qi in the stomach, abdominal pain, and nausea, Huanglian Tang is the main treatment." This aligns with the pathogenesis of COPD complicated by gastrointestinal dysfunction. This application, combining the symptoms of COPD complicated by gastrointestinal dysfunction, modifies the "Huanglian Tang" formula to create a topical Chinese medicine composition that promotes qi circulation, regulates bowel movements, balances cold and heat, and clears and descends turbidity. This restores spleen and stomach function, effectively alleviates patients' clinical symptoms, improves their quality of life, and is consistent with the basic pathogenesis of COPD.

[0026] The topical Chinese medicine composition of this application comprehensively addresses the symptoms of COPD complicated with gastrointestinal dysfunction. Through the rational combination of principal, assistant, adjuvant, and guide herbs, it follows the treatment principles of promoting qi circulation, regulating the bowels, harmonizing cold and heat, and ascending clear qi and descending turbid qi. By adjusting spleen and lung function, resolving phlegm and eliminating dampness, harmonizing cold and heat, and improving qi imbalance, it achieves the effect of treating both the symptoms and the root cause.

[0027] According to the principle of principal, assistant, adjuvant, and guide herbs, dried ginger and cinnamon twig are the principal herbs; stir-fried atractylodes macrocephala, codonopsis pilosula, and prepared pinellia ternata are the assistant herbs; raw rhubarb, coptis chinensis, immature bitter orange, and magnolia officinalis are the adjuvant herbs; and prepared licorice root is the guide herb. These ten herbs have different pharmacological effects. Dried ginger and cinnamon twig warm the middle jiao and dispel cold, unblock the meridians and resolve phlegm; stir-fried atractylodes macrocephala, codonopsis pilosula, and prepared pinellia ternata tonify the spleen and replenish qi, dry dampness and resolve phlegm, and relieve nausea and vomiting; rhubarb and coptis chinensis unblock the bowels and clear heat; immature bitter orange and magnolia officinalis regulate qi and eliminate stagnation; and prepared licorice root tonifies qi, replenishes the middle jiao, and harmonizes the effects of the other herbs.

[0028] Specifically, dried ginger warms the middle jiao and dispels cold, restores yang and unblocks the meridians, helping to improve lung qi stagnation and stomach cold and abdominal pain; cinnamon twig promotes sweating and relieves muscle tension, warms and unblocks the meridians, soothes lung qi, and relieves airway obstruction and gastrointestinal qi stagnation caused by cold invasion; stir-fried atractylodes macrocephala strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, improving poor appetite, loose stools and qi deficiency-related symptoms by enhancing the spleen and stomach's digestive function; codonopsis pilosula replenishes the middle jiao and replenishes qi, generates fluids and nourishes blood, relieving fatigue and weakness caused by qi deficiency and regulating spleen and stomach function to enhance the body's resistance to disease; raw rhubarb purges and eliminates stagnation, clears heat and detoxifies, clearing damp-heat endotoxins and phlegm, improving chronic obstructive pulmonary disease (COPD). For patients with lung disease, this combination of herbs addresses the heat stagnation and gastrointestinal stagnation. Coptis chinensis clears heat and dries dampness, purging fire and detoxifying, primarily targeting damp-heat syndrome, relieving symptoms such as thick yellow phlegm and vomiting due to stomach heat. Citrus aurantium breaks up qi stagnation, eliminates stagnation, and resolves phlegm and abdominal distension, effectively relieving chest tightness, cough, and gastrointestinal bloating caused by qi stagnation. Magnolia officinalis promotes qi circulation, eliminates stagnation, dries dampness, and resolves phlegm, regulating gastrointestinal qi, resolving phlegm, relieving asthma, and improving phlegm-dampness obstructing the lungs and abdominal distension and loose stools. Pinellia ternata dries dampness, resolves phlegm, and relieves nausea and vomiting, effectively treating cough and stomach qi reversal caused by phlegm-dampness obstruction. Glycyrrhiza uralensis tonifies the spleen and qi, moistens the lungs and relieves cough, and harmonizes the other herbs, resulting in a more balanced overall effect. In summary, this combination of herbs, through the synergistic effect of regulating lung and spleen function, treats both the root cause and symptoms, significantly alleviating multi-system symptoms caused by COPD combined with gastrointestinal dysfunction.

[0029] Among them: Dried ginger (5-30 parts): ensures the dispersing of cold pathogens and the restoration of spleen and stomach yang qi; insufficient use will not be able to improve spleen and stomach deficiency and cold. Cinnamon twig (5-30 parts): maintains the power to warm and unblock the meridians and works with dried ginger to dispel cold; insufficient use will not be able to relieve qi stagnation. Raw rhubarb (6-15 parts): ensures the purging and elimination of stagnation and heat; insufficient use will not be able to break up gastrointestinal stagnation. Coptis chinensis (6-20 parts): ensures the effects of clearing heat and drying dampness; insufficient use will not be able to control internal damp heat. Prepared Pinellia ternata (6-10 parts): meets the needs of drying dampness and resolving phlegm, and relieving nausea and vomiting; insufficient use will not be able to resolve phlegm and dampness. Prepared licorice root (6-20 parts): ensures the harmonization of all medicines and the tonification of spleen and qi; insufficient use will not be able to coordinate the properties of the medicines and assist in the recovery of spleen and stomach function.

[0030] Optionally, the external application traditional Chinese medicine composition consists of the following raw materials in parts by weight: 5-30 parts dried ginger, 5-30 parts cinnamon twig, 5-30 parts stir-fried atractylodes macrocephala, 5-30 parts codonopsis pilosula, 6-15 parts raw rhubarb, 6-20 parts coptis chinensis, 6-30 parts immature bitter orange, 6-30 parts magnolia bark, 6-10 parts processed pinellia ternata, and 6-20 parts prepared licorice root.

[0031] Optionally, the external application traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10-20 parts dried ginger, 10-20 parts cinnamon twig, 10-20 parts stir-fried atractylodes macrocephala, 10-20 parts codonopsis pilosula, 6-10 parts raw rhubarb, 6-20 parts coptis chinensis, 6-20 parts immature bitter orange, 6-20 parts magnolia officinalis, 6-10 parts processed pinellia ternata, and 6-15 parts prepared licorice root.

[0032] Optionally, the external application traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15 parts dried ginger, 15 parts cinnamon twig, 10 parts stir-fried atractylodes macrocephala, 10 parts codonopsis pilosula, 6 parts raw rhubarb, 10 parts coptis chinensis, 10 parts immature bitter orange, 10 parts magnolia bark, 9 parts processed pinellia ternata, and 10g prepared licorice root.

[0033] The second aspect of this application discloses a method for preparing a topical traditional Chinese medicine composition, wherein the preparation method is applied to the topical traditional Chinese medicine composition disclosed in the first aspect of this application, and the preparation method includes:

[0034] Weigh each raw material according to its weight and dry them separately.

[0035] The dried raw materials are first crushed, and then pulverized to 100-200 mesh at a preset temperature, preferably 100 mesh;

[0036] After pulverizing, mix them together to obtain the final product.

[0037] Optionally, the preset temperature is 5℃ to 10℃, preferably 8℃;

[0038] And / or, the drying temperature is 60℃-90℃;

[0039] And / or, the drying time is 10-20 minutes. In the actual preparation process, the drying temperature and drying time can be adjusted according to the humidity of the raw material.

[0040] The third aspect of this application discloses a topical Chinese medicine ointment, which includes an excipient and the topical Chinese medicine composition disclosed in the first aspect of this application. The excipient includes at least one of petrolatum, lanolin, beeswax, vegetable oil, and silicone oil.

[0041] Optionally, the preparation method of external Chinese medicine ointment is as follows: Take the excipient and heat it to a liquid state. Add the medicinal powder made from dried ginger, cinnamon twig, stir-fried Atractylodes macrocephala, Codonopsis pilosula, raw rhubarb, Coptis chinensis, immature bitter orange, magnolia officinalis, processed Pinellia ternata, and prepared licorice root to the excipient. Stir repeatedly to form a paste, let it stand and solidify into an ointment for later use.

[0042] The topical Chinese medicine ointment of this application can be prepared on the spot when used, or it can be pre-prepared and packaged for use at any time.

[0043] Optionally, the external herbal ointment is applied to the Shenque acupoint of the patient during ointment massage therapy.

[0044] The fourth aspect of this application discloses the use of the topical Chinese medicine composition proposed in the first aspect of this application or the topical Chinese medicine ointment proposed in the third aspect of this application in the preparation of a drug, wherein the drug is used to prevent and / or treat symptoms of COPD complicated with gastrointestinal dysfunction, wherein the symptoms include epigastric fullness, heartburn and acid reflux, dry mouth and bitter taste, cold limbs and loose stools, belching and loss of appetite.

[0045] Furthermore, the effects of regulating qi and bowel function, balancing cold and heat, and promoting the ascending of clear qi and descending of turbid qi include the effects on the condition of chronic gastritis and irritable bowel syndrome, manifested as loose stools, nausea, epigastric fullness, and abdominal distension.

[0046] Compared with the prior art, the beneficial effects of this application are as follows:

[0047] The external Chinese medicine composition and ointment of this application have the effects of regulating qi and bowel movement, balancing cold and heat, and promoting the upward movement of clear qi and downward movement of turbid qi. They are significantly effective in treating COPD complicated with gastrointestinal dysfunction, restoring the spleen and stomach function of patients, effectively relieving clinical symptoms and improving quality of life. Moreover, the Chinese medicine composition and ointment of this application are both external preparations, solving the problems of poor patient tolerance and increased gastrointestinal burden caused by oral medications. Attached Figure Description

[0048] Figure 1 This is the technical roadmap for the experimental examples in this application. Detailed Implementation

[0049] The present invention will be further described below through specific embodiments, but this is not a limitation of the present invention. Those skilled in the art can make various modifications or improvements based on the basic idea of ​​the present invention, but as long as they do not depart from the basic idea of ​​the present invention, they are all within the scope of the present invention.

[0050] Example 1

[0051] This embodiment presents a traditional Chinese medicine composition comprising 5 parts by weight of dried ginger, 5 parts by weight of cinnamon twig, 5 parts by weight of stir-fried Atractylodes macrocephala, 5 parts by weight of Codonopsis pilosula, 6 parts by weight of raw rhubarb, 6 parts by weight of Coptis chinensis, 6 parts by weight of immature bitter orange, 6 parts by weight of Magnolia officinalis, 6 parts by weight of processed Pinellia ternata, and 6 parts by weight of processed licorice root. The preparation method is as follows: The above medicinal materials are dried separately at a temperature of 60-90℃ for 10-20 minutes (drying time and temperature can be adjusted according to the moisture content of the raw materials). The dried medicinal materials are first crushed, then subjected to low-temperature pulverization at 8℃ until the particle size is 200 mesh. After pulverization, the mixture is combined and packaged to obtain the final product.

[0052] Example 2

[0053] This embodiment proposes a topical traditional Chinese medicine composition, which consists of 20 parts by weight of dried ginger, 10 parts by weight of cinnamon twig, 10 parts by weight of stir-fried atractylodes macrocephala, 30 parts by weight of codonopsis pilosula, 15 parts by weight of raw rhubarb, 20 parts by weight of coptis chinensis, 30 parts by weight of immature bitter orange, 20 parts by weight of magnolia officinalis, 10 parts by weight of processed pinellia ternata, and 15 parts by weight of prepared licorice root. The preparation method is as follows: The above medicinal materials are dried separately at a temperature of 60-90℃ for 10-20 minutes (the drying time can be adjusted according to the moisture content of the raw materials). The dried medicinal materials are first crushed, then subjected to low-temperature pulverization at 5℃ until the particle size is 200 mesh. After pulverization, the mixture is packaged to obtain the final product.

[0054] Example 3

[0055] This embodiment proposes a topical traditional Chinese medicine composition, which consists of 10 parts by weight of dried ginger, 20 parts by weight of cinnamon twig, 20 parts by weight of stir-fried Atractylodes macrocephala, 20 parts by weight of Codonopsis pilosula, 10 parts by weight of raw rhubarb, 20 parts by weight of Coptis chinensis, 20 parts by weight of Citrus aurantium, 30 parts by weight of Magnolia officinalis, 10 parts by weight of processed Pinellia ternata, and 20 parts by weight of processed licorice root. The preparation method is as follows: The above medicinal materials are dried separately at a temperature of 60-90℃ for 10-20 minutes (the drying time can be adjusted according to the moisture content of the medicinal materials). The dried medicinal materials are first crushed, then subjected to low-temperature pulverization at 10℃ until the particle size is 100 mesh. After pulverization, the mixture is packaged to obtain the final product.

[0056] Example 4

[0057] This embodiment proposes a topical traditional Chinese medicine composition, which consists of 30 parts by weight of dried ginger, 30 parts by weight of cinnamon twig, 30 parts by weight of stir-fried Atractylodes macrocephala, 10 parts by weight of Codonopsis pilosula, 15 parts by weight of raw rhubarb, 20 parts by weight of Coptis chinensis, 20 parts by weight of Citrus aurantium, 20 parts by weight of Magnolia officinalis, 10 parts by weight of processed Pinellia ternata, and 15 parts by weight of processed licorice root. The preparation method is as follows: The above medicinal materials are dried separately at a temperature of 60-90℃ for 10-20 minutes (the drying time can be adjusted according to the moisture content of the medicinal materials). The dried medicinal materials are first crushed, then subjected to low-temperature pulverization at 8℃ until the particle size is 200 mesh. After pulverization, the mixture is packaged to obtain the final product.

[0058] Example 5

[0059] This embodiment proposes a topical traditional Chinese medicine composition, which consists of 15 parts by weight of dried ginger, 15 parts by weight of cinnamon twig, 15 parts by weight of stir-fried Atractylodes macrocephala, 15 parts by weight of Codonopsis pilosula, 8 parts by weight of raw rhubarb, 12 parts by weight of Coptis chinensis, 15 parts by weight of immature bitter orange, 10 parts by weight of Magnolia officinalis, 8 parts by weight of processed Pinellia ternata, and 10 parts by weight of prepared licorice root. The preparation method is as follows: The above medicinal materials are dried separately at a temperature of 60-90℃ for 10-20 minutes (the drying time can be adjusted according to the moisture content of the medicinal materials). The dried medicinal materials are first crushed, then subjected to low-temperature pulverization at 10℃ until the particle size is 100 mesh. After pulverization, the mixture is packaged to obtain the final product.

[0060] Example 6

[0061] This embodiment proposes a topical traditional Chinese medicine composition, which consists of 15 parts by weight of dried ginger, 15 parts by weight of cinnamon twig, 10 parts by weight of stir-fried Atractylodes macrocephala, 10 parts by weight of Codonopsis pilosula, 6 parts by weight of raw rhubarb, 10 parts by weight of Coptis chinensis, 10 parts by weight of Citrus aurantium, 10 parts by weight of Magnolia officinalis, 9 parts by weight of processed Pinellia ternata, and 10 parts by weight of processed licorice root. The preparation method is as follows: The above medicinal materials are dried separately at a temperature of 60-90℃ for 10-20 minutes (the drying time can be adjusted according to the moisture content of the medicinal materials). The dried medicinal materials are first crushed, then subjected to low-temperature pulverization at 8℃ until the particle size is 200 mesh. After pulverization, the mixture is packaged to obtain the final product.

[0062] Example 7

[0063] This embodiment proposes a topical traditional Chinese medicine ointment, which includes an excipient and the topical traditional Chinese medicine composition of Example 6. The preparation method of the topical traditional Chinese medicine ointment is as follows: Take 400ml of the excipient and heat it in a microwave oven on medium heat for about 9 minutes to melt the excipient into a liquid state. Take 200g of the topical traditional Chinese medicine composition and add it to the liquid excipient, stir repeatedly for 10 minutes to form a paste, let it stand for 90 minutes to solidify into an ointment, and the ointment is obtained.

[0064] The excipients include at least one of petrolatum, lanolin, beeswax, vegetable oil, and silicone oil.

[0065] Test case

[0066] Trial objective: To evaluate the efficacy of the topical Chinese medicine ointment of this application in treating chronic obstructive pulmonary disease (COPD) complicated with gastrointestinal dysfunction (mixed cold and heat syndrome) through a randomized controlled clinical trial.

[0067] Experiment Content: For patients with COPD complicated by gastrointestinal dysfunction, in addition to routine Western medicine treatment, the treatment group received external application of traditional Chinese medicine ointment (Example 7) using a traditional Chinese medicine ointment massage therapy. The efficacy was compared with the control group (routine Western medicine treatment). The study aimed to evaluate the efficacy of the external application of traditional Chinese medicine ointment in patients with COPD complicated by gastrointestinal dysfunction, clarifying its effects on improving patients' TCM symptom scores, carbon dioxide retention, oxygenation index, lung function, diaphragmatic range of motion, and six-minute walking distance. This provides evidence-based medical evidence for the treatment of COPD complicated by gastrointestinal dysfunction using traditional Chinese medicine ointment massage, and aims to develop a complete and widely applicable traditional Chinese medicine ointment massage therapy for COPD complicated by gastrointestinal dysfunction (cold-heat syndrome), which can be promoted and applied in the practice of hierarchical medical treatment.

[0068] Test method:

[0069] 1.1 Experimental Design

[0070] The experiment was conducted using a randomized, controlled method, and the design was an effectiveness study.

[0071] The randomization protocol employed a simple randomization method, using SAS software to generate the randomization scheme. Participants were randomly assigned to either an experimental group (conventional Western medicine treatment + topical Chinese herbal ointment) or a control group (conventional Western medicine treatment), with a 1:1 ratio between the two groups. Each group was sealed in an opaque envelope, numbered accordingly, with the envelope number matching the serial number of the card inside. The randomization cards were kept by a designated person. Upon entry into the trial, eligible participants opened envelopes with matching serial numbers in their order of entry and received treatment according to the group assignments and medical instructions specified on the cards. Blinding was implemented by blinding both the evaluators and data processors.

[0072] 1.2 Test Subjects

[0073] This study recruited patients with COPD complicated by gastrointestinal dysfunction (mixed cold and heat syndrome) who visited the Fangshan District Traditional Chinese Medicine Hospital in Beijing. Patients were randomly assigned to a treatment group (conventional Western medicine treatment plus topical Chinese medicine ointment) or a control group (conventional Western medicine treatment). The sample size was calculated to be 60 patients in each group, for a total sample size of 120 patients.

[0074] 12.1 Diagnostic criteria:

[0075] (1) Make a definitive diagnosis of chronic obstructive pulmonary disease (COPD), referring to the 2021 Chinese Medical Association Guidelines for the Diagnosis and Treatment of COPD. COPD is diagnosed based on medical history, risk factors, physical signs and pulmonary function tests. Persistent airflow limitation is defined as FEV1 / FVC < 70% after the use of bronchodilators.

[0076] (2) Meeting the diagnostic criteria for gastrointestinal dysfunction: The diagnostic criteria for gastrointestinal dysfunction in this study were based on the 2012 European Society of Intensive Care Medicine (ESICM) definition of gastrointestinal dysfunction. Symptoms of gastrointestinal dysfunction include nausea and vomiting, loss of appetite, abdominal distension, diarrhea, and constipation. The symptom score distribution is as follows:

[0077] 0 points: No abdominal bloating; normal bowel sounds;

[0078] 1 point: Abdominal bloating; decreased bowel sounds;

[0079] 2 points: Severe abdominal distension; bowel sounds are almost absent, and intra-abdominal pressure is increased;

[0080] 3 points: Paralytic ileus, stress ulcer bleeding, non-calculous acute cholecystitis, acute pancreatitis (any one of these conditions is sufficient for diagnosis);

[0081] Based on the above diagnostic criteria, patients with gastrointestinal scores of 1 and 2 were selected.

[0082] (3) Meets the TCM diagnostic criteria for mixed cold and heat syndrome: The TCM syndrome differentiation is based on the "Guidelines for Clinical Practice of Pi Mang in TCM" (2018 and the "Guiding Principles for Clinical Research of New Chinese Medicine Drugs (Trial)" edited by Zheng Xiaoyu in 2002), specifically the Pi Man chapter, as follows:

[0083] Mixed Cold and Heat Syndrome: Main symptoms: fullness and distension in the stomach, aggravated by cold, heartburn and acid reflux, dry mouth and bitter taste, cold limbs and loose stools.

[0084] Secondary symptoms: belching, loss of appetite.

[0085] Tongue and pulse: Pale tongue with a thin white coating, and a wiry and rapid pulse.

[0086] Syndrome diagnosis: Two primary symptoms and two secondary symptoms, along with reference to the tongue and pulse, are sufficient for diagnosis.

[0087] 1.2.2 Inclusion Criteria

[0088] (1) Patients whose Western medicine diagnosis meets the diagnostic criteria for COPD and gastrointestinal dysfunction, and whose gastrointestinal scores are 1 and 2.

[0089] (2) The TCM syndrome differentiation meets the diagnostic criteria for mixed cold and heat syndrome;

[0090] (3) Age 30-85 years old;

[0091] (4) The subject or their family members agree and sign the informed consent form.

[0092] 1.2.3 Exclusion Criteria

[0093] (1) Patients with severe heart, liver, or kidney damage or severe cognitive impairment who are unable to cooperate with examinations and treatments;

[0094] (2) Patients with organic lesions of the upper gastrointestinal tract, such as peptic ulcers, pyloric obstruction, or space-occupying lesions of the upper gastrointestinal tract (gastroscopy may be performed if necessary);

[0095] (3) Those with serious primary diseases of other organs or systems;

[0096] (4) Abdominal skin diseases that cannot be treated with traditional Chinese medicine ointment;

[0097] (5) Individuals allergic to the ingredients of topical Chinese medicine ointments.

[0098] 1.2.4 Case dropout criteria

[0099] Treatment with external Chinese herbal ointments was not performed in accordance with regulations, or the efficacy could not be determined, or the data was incomplete, which affected the determination of efficacy and safety.

[0100] 1.3 Experimental methods, observation indicators, and follow-up plan

[0101] Both groups of patients received routine Western medicine treatment as currently available in clinical practice, with specific treatment plans following the 2021 Chinese Medical Association Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease.

[0102] Treatment group: Conventional Western medicine treatment plan + external application of traditional Chinese medicine ointment.

[0103] The steps for using traditional Chinese medicine plaster massage therapy are as follows:

[0104] ① Prepare the external Chinese medicine ointment for Example 7;

[0105] ② Preheat the Bian stone moxibustion device, initially adjust the temperature of the Bian stone to 60℃;

[0106] ③ Instruct the patient to lie supine with their abdomen exposed, select the corresponding acupoints, and cover the subject's lower abdomen with a treatment towel;

[0107] ④ Apply an appropriate amount of ointment to the Shenque acupoint on the abdomen, and adjust the temperature of the moxibustion device according to the subject's tolerance.

[0108] ⑤ Hold the moxibustion device in your hand and apply pressure with your wrist. The depth of pressure depends on the subject's tolerance and fat thickness. Start pressing the acupoints from Shenque (CV8), then pass through Qihai (CV6), Guanyuan (CV4), Tianshu (ST25) (right side), Zhongwan (CV12), Tianshu (ST25) (left side), and then back to Qihai (CV6). Massage continuously in a clockwise direction for 15 minutes, and finally at Tianshu (ST25) (left side).

[0109] ⑥ During the procedure, pay attention to the patient's feelings and adjust the intensity and temperature accordingly;

[0110] ⑦ After the ointment massage, wrap the abdomen with plastic wrap to maintain the temperature for 20 minutes. During the application period, carefully observe the patient's skin condition.

[0111] ⑧ After treatment, apply the ointment to the patient's abdomen, clean the skin, and inform them of precautions.

[0112] Control group: Standard Western medicine treatment plan.

[0113] Combined medication and prohibited medication:

[0114] If patients have underlying conditions such as hypertension or diabetes, their routine medications should not be affected and should be recorded accurately; both groups of patients should avoid using prokinetic drugs.

[0115] Treatment cycle: 5 consecutive days of treatment, 2 days of rest, 7 days as one course of treatment, 2 consecutive courses of treatment.

[0116] 1.3.1 Observation Methods

[0117] Follow-up observation start point: The day the patient receives treatment is the start point of follow-up, and the patient's basic characteristics (such as age, gender, comorbidities, TCM symptom scores, etc.) are recorded.

[0118] Observation endpoint: The observation and treatment period for this trial was 2 weeks, with a follow-up period of 2 weeks. At week 2 ± 1 day and week 4 ± 1 day after the start of the follow-up observation, the patients' TCM symptom scores, ΔPCO2, oxygenation index, diaphragmatic movement amplitude, mMRC dyspnea score, pulmonary function, and six-minute walk distance were recorded to analyze the clinical efficacy.

[0119] 1.3.2 Observation Indicators

[0120] 1.3.2.1 Main therapeutic efficacy observation indicators

[0121] (1) TCM symptom score: The TCM symptoms of the subjects, such as epigastric fullness, heartburn and acid reflux, dry mouth and bitter taste, cold limbs and loose stools, belching and poor appetite, were scored as 0, 1, 2 and 3 points respectively, according to the categories of none, mild, moderate and severe. The total score and the scores of each item were evaluated separately.

[0122] 1.3.2.2 Secondary efficacy observation indicators

[0123] (1) Oxygenation index: equal to oxygen partial pressure divided by inhaled oxygen concentration.

[0124] (2) Diaphragmatic range of motion: The patient lies supine, and the ultrasound probe is placed at the junction of the anterior axillary line or the midclavicular line and the costal margin (bilaterally), with the probe marker pointing outward and downward. Locate the diaphragm to be measured in 2D mode, select M mode, and align the sampling line perpendicular to the diaphragm to measure the diaphragmatic range of motion. Normal values ​​for diaphragmatic range of motion in adults are as follows (cm):

[0125] Diaphragmatic range of motion Breathe calmly Inhalation test - smell Take the deepest breath male 1.8±0.3 2.9±0.6 7.0±0.6 female 1.6±0.3 2.6±0.5 5.7±1.0

[0126] (3) ΔPCO2: Select the partial pressure of carbon dioxide on the day of treatment minus the partial pressure of carbon dioxide 2 weeks and 4 weeks after treatment. A decrease in partial pressure of carbon dioxide after treatment is recorded as a positive value, and an increase in partial pressure of carbon dioxide after treatment is recorded as a negative value.

[0127] (4) mMRC dyspnea score: mMRC dyspnea score was measured on the day of treatment, 2 weeks after treatment, and 4 weeks after treatment.

[0128] (5) Lung function: FEV1, FEV1 / FVC, and DLCO were measured on the day of treatment, 2 weeks after treatment, and 4 weeks after treatment.

[0129] (6) Six-minute walking distance: The six-minute walking distance was measured on the day of treatment, 2 weeks after treatment, and 4 weeks after treatment.

[0130] 1.3.2.3 Safety Observation

[0131] (1) General physical examination items: routine blood and urine tests; liver function and kidney function tests; blood electrolyte tests.

[0132] (2) Adverse event observation: Detailed records of any adverse events, side effects, or adverse drug reactions occurring during the trial, such as allergies, local skin redness, itching, pain, or ulceration, should be kept in the patient log card. Record any deaths of any cause and assess the relationship between the event and the treatment with the topical Chinese medicine ointment.

[0133] 1.4 Sample Size Estimation

[0134] The formula for calculating the sample size in the effectiveness test is as follows:

[0135]

[0136] Based on the experimental results, the estimated efficacy rate for the experimental group is 80%, and for the control group, it is 50%. This is an efficacy trial, with a Type I error threshold (α) set at 0.025 (one-sided) and a power (β) of 0.2. The sample allocation ratio between the treatment and control groups is 1:1, requiring 50 cases per group. To control the dropout rate below 20%, the final sample size per group is 60 cases, for a total sample size of 120 cases.

[0137] 1.5 Statistical Methods

[0138] Statistical analysis was performed using SPSS 26.0 software. All hypothesis tests were two-tailed, with a p-value ≤ 0.05 considered statistically significant. In descriptive statistics, count data were described using frequency, percentage, or proportion; continuous data were described using mean ± standard deviation, and skewed distributions were described using percentile statistics. Comparisons between the experimental and control groups were performed using the Chi-Square test (X2) for count data, Fisher's exact test, or Wilcoxon's rank-sum test. For continuous data conforming to a normal distribution, the t-test was used; otherwise, the Wilcoxon rank-sum test was used. The Cochran-Mantel-Haensel (CMH) test was used to consider the center effect.

[0139] 1.6 Data Acquisition and Management

[0140] (1) Establish a quality control team, with the project leader serving as the quality control team leader, and quality control supervision throughout the entire research process.

[0141] (2) Provide unified training to project team members on guiding patients in traditional Chinese medicine ointment massage therapy, and ensure that the guidance is standardized.

[0142] (3) Each case in the treatment group must undergo training by medical staff to ensure the quality of the traditional Chinese medicine plaster treatment and minimize the deviation in treatment effect.

[0143] (4) Hire personnel outside the research group (third parties) to conduct blinded efficacy evaluations to avoid the subjective influence of research group members.

[0144] (5) For cases that are lost to follow-up, the reasons for each case will be analyzed.

[0145] (6) At the same time, collect the basic characteristics of the subjects before the intervention (such as age, gender, comorbid diseases, etc.) to ensure the balance of the distribution of the two experimental groups.

[0146] (7) After training, a specialist will conduct lung function tests, six-minute walking distance tests, and TCM symptom score evaluations to ensure the quality of testing.

[0147] 2. Technical approach: such as Figure 1 .

[0148] 3. Quality control measures during clinical trials

[0149] 3.1 Bias Analysis

[0150] In the design of this experiment, potential biases were considered, including: ① selection bias in the early stages due to lax inclusion criteria; and ② measurement bias during the trial due to confounding factors. To address these potential biases, this experiment aims to rigorously train experiment personnel, implement quality control over inclusion criteria, and minimize selection bias through a randomized design. The experimental protocol employs a randomized, controlled method. Due to the specific nature of the intervention, blinding the experiment personnel is not feasible. Therefore, we have specifically appointed statistical analysts who do not participate in the experimental design and implementation, and who perform statistical analysis using a blinded approach to minimize measurement bias.

[0151] 3.2 Quality control of test personnel

[0152] 3.2.1 Personnel Qualifications

[0153] (1) Clinical intervention implementers: must be licensed physicians and have relevant clinical work experience.

[0154] (2) Clinical evaluation personnel: must have relevant clinical research experience.

[0155] (3) Data entry personnel: Those with a medical background and familiar with routine computer operations.

[0156] (4) Quality inspectors: those with relevant work experience.

[0157] 3.2.2 Personnel Training

[0158] In accordance with the requirements of the test manual, relevant training was provided to the personnel involved in the test.

[0159] 3.3 Measures to improve subject compliance

[0160] Through the thoughtful, meticulous, enthusiastic and patient service of medical staff, we will strengthen the publicity and education of medical knowledge, explain the details of the intervention plan to the subjects, arrange the consultation time reasonably, communicate with the subjects more by phone, and use appointment and other methods to improve the compliance of the subjects.

[0161] 4. Test Results

[0162] 4.1 Traditional Chinese Medicine Symptom Scoring

[0163] In the control group, the increase was observed in the second week after treatment compared to the first week, but the difference was not statistically significant; the increase was significant in the fourth week compared to the first week, and the difference was statistically significant; the increase was also observed in the fourth week compared to the second week, but the difference was not statistically significant.

[0164] Comparing the treatment group before and after treatment, the second and fourth weeks after treatment showed a significant decrease compared to the first week, with statistically significant differences; the fourth week showed a decreasing trend compared to the second week, but the difference was not statistically significant.

[0165] There was no statistically significant difference in TCM symptom scores between the control and treatment groups at enrollment (i.e., week 1); however, at weeks 2 and 4 after treatment, the TCM symptom scores in the treatment group showed a significant decrease compared to the control group (P < 0.001). This suggests that the TCM symptom scores in the treatment group improved more significantly.

[0166] Table 1 Traditional Chinese Medicine Symptom Scoring Table

[0167]

[0168] Note: a: compared with the control group, b: compared with week 1, c: compared with week 2, *: P < 0.05, ***: P < 0.001, ns: no statistical significance.

[0169] 4.2 PCO2 (Carbon Dioxide Retention)

[0170] Compared with the control group before and after treatment, the second and fourth weeks after treatment showed a downward trend compared with the first week, but the difference was not statistically significant; the fourth week showed a downward trend compared with the second week, but the difference was not statistically significant.

[0171] Comparing the treatment group before and after treatment, the second and fourth weeks after treatment showed a downward trend compared to the first week, but the difference was not statistically significant; the fourth week also showed a downward trend compared to the second week, but the difference was not statistically significant.

[0172] Comparing the control group and the treatment group, there was a significant difference in carbon dioxide partial pressure between the two groups at enrollment (i.e., the first week), with the treatment group showing a higher value, and the difference was statistically significant. However, at the second and fourth weeks after treatment, there were no statistically significant differences between the treatment group and the control group.

[0173] Table 2. Partial Pressure Values ​​of Carbon Dioxide

[0174]

[0175] Note: a: compared with the control group, b: compared with week 1, c: compared with week 2, *: P < 0.05, ns: no statistical significance.

[0176] 4.3 Oxygenation Index

[0177] Compared with the control group before and after treatment, the second and fourth weeks after treatment showed a downward trend compared with the first week, but the difference was not statistically significant; the fourth week showed a downward trend compared with the second week, but the difference was not statistically significant.

[0178] Comparing the treatment group before and after treatment, the second and fourth weeks after treatment showed a downward trend compared to the first week, but the difference was not statistically significant; the fourth week also showed a downward trend compared to the second week, but the difference was not statistically significant.

[0179] There was no significant difference in oxygenation index between the control group and the treatment group at enrollment (i.e., the first week); there were no statistically significant differences between the treatment group and the control group at the second and fourth weeks after treatment.

[0180] Table 3 Oxygenation Index

[0181]

[0182] Note: a: compared with the control group, b: compared with week 1, c: compared with week 2, ns: no statistically significant difference.

[0183] 4.4 Lung function (FEV1 / FVC)

[0184] Compared with the control group before and after treatment, the second and fourth weeks after treatment showed an upward trend compared with the first week, but the difference was not statistically significant; the fourth week showed a downward trend compared with the second week, but the difference was not statistically significant.

[0185] Comparing the treatment group before and after treatment, the second and fourth weeks after treatment showed an upward trend compared to the first week, but the difference was not statistically significant; the fourth week showed a downward trend compared to the second week, but the difference was not statistically significant.

[0186] There was no significant difference in lung function between the control group and the treatment group at enrollment (i.e., the first week); there were no statistically significant differences between the treatment group and the control group at the second and fourth weeks after treatment.

[0187] Table 4 Lung Function Table

[0188]

[0189] Note: a: compared with the control group, b: compared with week 1, c: compared with week 2, ns: no statistically significant difference.

[0190] 4.5 Diaphragmatic range of motion

[0191] Compared with the control group before and after treatment, the second and fourth weeks after treatment showed a downward trend compared with the first week, but the difference was not statistically significant; the fourth week showed an upward trend compared with the second week, but the difference was not statistically significant.

[0192] Comparing the treatment group before and after treatment, the second and fourth weeks after treatment showed an upward trend compared to the first week, but the difference was not statistically significant; the fourth week showed a downward trend compared to the second week, but the difference was not statistically significant.

[0193] Comparing the control and treatment groups, there was no significant difference in diaphragmatic movement amplitude between the two groups at enrollment (i.e., week 1); at weeks 2 and 4 after treatment, there were no statistically significant differences between the treatment and control groups. Although there was no statistically significant difference in diaphragmatic movement amplitude between the two groups at weeks 2 and 4 after treatment, it can be seen that the diaphragmatic movement amplitude in the treatment group consistently increased, while that in the control group significantly decreased after treatment compared to enrollment, suggesting that patients in the treatment group recovered ventilation function better.

[0194] Table 5. Diaphragmatic Movement Amplitude Table

[0195]

[0196] Note: a: compared with the control group, b: compared with week 1, c: compared with week 2, ns: no statistically significant difference.

[0197] 4.6 six-minute walk

[0198] Compared with the control group before and after treatment, the second and fourth weeks after treatment showed a downward trend compared with the first week, but the difference was not statistically significant; the fourth week showed an upward trend compared with the second week, but the difference was not statistically significant.

[0199] Comparing the treatment group before and after treatment, the second and fourth weeks after treatment showed an upward trend compared to the first week, but the difference was not statistically significant; the fourth week also showed an upward trend compared to the second week, but the difference was not statistically significant.

[0200] Comparing the control group and the treatment group, there was no significant difference in the six-minute walking distance between the two groups at enrollment (i.e., the first week). In the second and fourth weeks after treatment, there was no statistically significant difference between the treatment group and the control group. However, in these two comparisons after treatment, it was found that the six-minute walking distance in the treatment group increased, while that in the control group decreased, suggesting that the cardiopulmonary function and exercise tolerance of the patients in the treatment group recovered better.

[0201] Table 6 Six-minute walking distance table

[0202]

[0203] Note: a: compared with the control group, b: compared with week 1, c: compared with week 2, ns: no statistically significant difference.

[0204] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A topical traditional Chinese medicine composition for the prevention and / or treatment of COPD complicated with gastrointestinal dysfunction, characterized in that, The external application traditional Chinese medicine composition consists of the following raw materials: 5-30 parts by weight of dried ginger, 5-30 parts by weight of cinnamon twig, 5-30 parts by weight of stir-fried Atractylodes macrocephala, 5-30 parts by weight of Codonopsis pilosula, 6-15 parts by weight of raw rhubarb, 6-20 parts by weight of Coptis chinensis, 6-30 parts by weight of immature bitter orange, 6-30 parts by weight of magnolia bark, 6-10 parts by weight of processed Pinellia ternata, and 6-20 parts by weight of prepared licorice root.

2. The topical traditional Chinese medicine composition according to claim 1, characterized in that, The external application Chinese medicine composition consists of the following raw materials in parts by weight: 10-20 parts dried ginger, 10-20 parts cinnamon twig, 10-20 parts stir-fried Atractylodes macrocephala, 10-20 parts Codonopsis pilosula, 6-10 parts raw rhubarb, 6-20 parts Coptis chinensis, 6-20 parts immature bitter orange, 6-20 parts magnolia bark, 6-10 parts processed Pinellia ternata, and 6-15 parts prepared licorice root.

3. The external application traditional Chinese medicine composition according to claim 1, characterized in that, The external application Chinese medicine composition consists of the following raw materials in parts by weight: 15 parts dried ginger, 15 parts cinnamon twig, 10 parts stir-fried atractylodes macrocephala, 10 parts codonopsis pilosula, 6 parts raw rhubarb, 10 parts coptis chinensis, 10 parts immature bitter orange, 10 parts magnolia bark, 9 parts processed pinellia ternata, and 10 parts prepared licorice root.

4. A method for preparing the external application traditional Chinese medicine composition according to any one of claims 1-3, the preparation method comprising: Weigh each raw material according to its weight and dry it; The dried raw materials are first crushed, and then pulverized to 100-200 mesh at a preset temperature; After pulverizing, mix them together to obtain the final product.

5. The preparation method according to claim 4, characterized in that, The preset temperature is 5℃~10℃; And / or, the drying temperature is 60℃-90℃; And / or, the drying time is 10-20 minutes.

6. A topical traditional Chinese medicine ointment for the prevention and / or treatment of COPD complicated with gastrointestinal dysfunction, characterized in that, The external herbal ointment comprises excipients and the external herbal composition according to any one of claims 1-3: The excipients include at least one selected from petrolatum, lanolin, beeswax, vegetable oil, and silicone oil. The topical Chinese medicine ointment is applied to the Shenque acupoint of the patient during ointment massage therapy.

7. The use of the external Chinese medicine composition according to any one of claims 1-3 or the external Chinese medicine ointment according to claim 6 in the preparation of a drug, characterized in that, The drug is used to prevent and / or treat symptoms of COPD complicated with gastrointestinal dysfunction, including epigastric fullness, heartburn, acid reflux, dry mouth and bitter taste, cold limbs and loose stools, belching and loss of appetite.

8. The application according to claim 7, characterized in that, The condition described is chronic gastritis and irritable bowel syndrome, and is characterized by loose stools, nausea, fullness, and bloating.

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