Traditional Chinese medicine composition for treating complications after endotracheal intubation of gastrointestinal tumor diseases as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating endotracheal intubation postoperative complications of gastrointestinal tumor diseases and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 36-45 parts of radix puerariae, 26-35 parts of semen sterculiae lychnophorae, 5-15 parts of fructus momordicae and 16-25 parts of flos chrysanthemi. The invention further discloses a preparation method and application of the traditional Chinese medicine composition. The radix puerariae is used as a monarch drug, is different from other sore-throat relieving Chinese patent medicine formulas, focuses on a body fluid production promoting method for consolidating basis, not only can clear heat, promote fluid production and moisten the throat, but also can regulate the spleen and the stomach, is more lasting in drug effect compared with other pure sore-throat relieving granules, and achieves the effects of moistening the throat, promoting fluid production, quenching thirst and relieving sore-throat by combining the four drugs; clinical observation proves that the traditional Chinese medicine composition can effectively relieve uncomfortable symptoms such as postoperative pharyngalgia and dry throat, prevent pulmonary infection, protect spleen and stomach functions and promote rapid postoperative rehabilitation.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases, as well as a preparation method and application thereof. Background Art

[0002] Throat discomfort is a common complication after general anesthesia and endotracheal intubation. During general anesthesia surgery, patients need to use an endotracheal tube for ventilation. During intubation, certain reasons may cause certain damage to the throat and tracheal mucosa, leading to postoperative throat pain. In addition, general anesthesia drugs can affect the patient's swallowing and respiratory mucosal secretions, causing mucosal dryness, which can cause throat discomfort in patients. Severe cases may cause throat inflammation and respiratory tract infection, affecting the patient's postoperative recovery.

[0003] Currently, glucocorticoids or expectorant aerosols are primarily used clinically to reduce throat mucosal edema and prevent sore throat. Other traditional Chinese medicine (TCM) techniques, such as bloodletting, scraping, and plastering, as well as herbal teas and lozenges, can also be used to alleviate postoperative sore throat. Literature reports suggest that the Kaihoujian spray has shown promising clinical efficacy in treating postoperative sore throat in patients undergoing endotracheal intubation and general anesthesia. Kaihoujian spray, composed of ingredients such as Sophora flavescens, Bazhuajinlong, menthol, and cicada sloughs, is commonly used to treat pharyngitis, stomatitis, and tonsillitis. Some practitioners also use heat-clearing and detoxifying Chinese patent medicine granules for oral administration to relieve sore throat and inflammation. For example, Houyanqing Granules (Hunan Times Sunshine Pharmaceutical Co., Ltd., batch number 20190911) can be used for postoperative sore throat after general anesthesia. Clinical observations have demonstrated its effectiveness in relieving postoperative sore throat. Composed primarily of four herbs: Achyranthes bidentata, Amaranthus chinensis, Plantago asiatica, and Tianmingjing, the spray has the properties of clearing heat and detoxifying, relieving sore throat, and alleviating sore throat.

[0004] Although glucocorticoids or expectorant aerosols have shown some efficacy in treating edema of the pharyngeal mucosa, with the development of medical knowledge, some patients are reluctant to use hormones, fearing their side effects. Traditional Chinese medicine products, such as Houyanqing Granules, Kaihoujian Spray, or other lozenges, are mostly used to treat pharyngitis, tracheitis, and oral inflammation. These traditional Chinese medicines often have the effect of clearing away heat and detoxifying, but are too irritating for patients with gastrointestinal tumors, especially those whose gastrointestinal function has not yet recovered in the early postoperative period. They can cause gastrointestinal discomfort in some patients with weak spleen and stomach.

[0005] Existing medications for treating throat discomfort are not suitable for postoperative patients. For example, Chinese invention patent application number 201010558748.5 discloses a pangdahai granule, which includes pangdahai, yam, black plum, polygonatum, licorice, lily, almond, monk fruit, green fruit, houttuynia cordata, ginger, mulberry leaf, platycodon grandiflorum, bamboo leaf, chrysanthemum, kudzu root, dandelion, and fresh cogongrass root. This product has a complex flavor profile, with the black plum being sour and the houttuynia cordata and dandelion being too cold. This product has a certain impact on the recovery of gastrointestinal function in postoperative patients, making it unsuitable for use within 6-48 hours after general anesthesia for gastrointestinal cancer patients. For example, the Chinese invention patent application number 201110259839.3 discloses a Chinese patent medicine granule for treating chronic pharyngitis, the raw materials of which include scutellaria baicalensis, platycodon grandiflorum, bamboo shavings, anemarrhena asphodeloides, poria cocos, mulberry leaves, cyperus rotundus, lily, red dates, walnuts, licorice, chrysanthemum, agarwood, pteridophytum corylifolia, perilla seed, menthol, momordica grosvenori, peony bark, and Sophora flavescens root; the product has a complex flavor, in which menthol and agarwood have strong spicy flavors, and walnut has a hard texture. It is mainly suitable for chronic pharyngitis caused by respiratory tract infection, and is not suitable for use in patients with gastrointestinal tumors within 6 to 48 hours after tracheal general anesthesia. For example, Chinese invention patent application number 201810539098.6 discloses a throat-clearing and anti-inflammatory granule health product, whose ingredients include Ampelopsis gracile, honeysuckle, chrysanthemum, mint, monk fruit, puffed sea cucumber, roasted licorice root, and honey. While this product is both medicinal and edible, the mint has a strong pungent flavor, and the honey moisturizes the intestines and can cause diarrhea. It is primarily used for pharyngitis caused by respiratory infections and is not suitable for gastrointestinal cancer patients within 6 to 48 hours after general tracheal anesthesia. Another example is Chinese invention patent application number 201610380876.2, which discloses a health tea for treating pharyngitis and its preparation method. Its ingredients include jasmine, scutellaria baicalensis, mulberry leaves, honeysuckle, puffed sea cucumber, green fruit, monk fruit, and licorice root. This product is primarily used for chronic pharyngitis. It contains jasmine tea leaves and puffed sea cucumber, which clear heat and dampness and have a cooling effect. It is not suitable for gastrointestinal cancer patients within 6 to 48 hours after general tracheal anesthesia. For example, Chinese invention patent application number 201110357796.2 discloses a pharmaceutical composition and preparation method for treating pharyngitis, whose raw materials include Momordica grosvenori, honeysuckle, chrysanthemum, ophiopogon japonicus, Sterculia lychnophora, licorice, and tea. Although this product is both a medicine and food, it contains tea and is used for gastrointestinal cancer patients within 6 to 48 hours after general anesthesia, as they are prone to postoperative stress and insomnia, making tea-based medications unsuitable. Furthermore, this invention is primarily used for pharyngitis caused by respiratory infections and is not suitable for gastrointestinal cancer patients within 6 to 48 hours after general anesthesia. Another example is Chinese invention patent application number 200910092241.2, which discloses a functional food and drug for clearing the throat, and its preparation method, whose raw materials include honeysuckle, Momordica grosvenori, chrysanthemum, Sterculia lychnophora, and menthol.Although this product is both a medicine and a food, it has a strong pungent flavor due to menthol and is mainly used to treat pharyngitis caused by respiratory tract infections. It is not suitable for patients with gastrointestinal tumors within 4 to 48 hours after tracheal general anesthesia.

[0006] As can be seen from the above, currently used throat-relieving medications are mostly for pharyngitis caused by respiratory tract infections, using herbs such as mint, scutellaria, and black plum. However, some patients with gastrointestinal tumors may experience digestive tract irritation and nausea approximately six hours after surgery. Currently, there are few targeted products for treating throat complications caused by endotracheal intubation in patients undergoing general anesthesia for gastrointestinal tumors, and further research is needed. Summary of the Invention

[0007] Taking into account the weak spleen and stomach of patients who fast after surgery, the present invention adopts Chinese medicine with the same origin as food, which can achieve the purpose of clearing heat and relieving sore throat while having the smallest possible impact on the gastrointestinal function of the patients, and is suitable for a wide range of people.

[0008] In order to achieve the above object, the present invention adopts the following technical solutions:

[0009] A traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases is composed of the following raw materials in parts by mass: 36-45 parts of kudzu root, 26-35 parts of pterostilbene, 5-15 parts of momordica grosvenori, and 16-25 parts of chrysanthemum.

[0010] Preferably, the traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases is composed of the following raw materials in parts by mass: 38-43 parts of Pueraria root, 28-33 parts of Sterculia lychnophora, 7-13 parts of Momordica grosvenori, and 18-23 parts of Chrysanthemum.

[0011] Preferably, the traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases is composed of the following raw materials in parts by mass: 40 parts of Pueraria root, 30 parts of Sterculia lychnophora, 10 parts of Momordica grosvenori, and 20 parts of Chrysanthemum.

[0012] The present invention provides the use of the above-mentioned traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases in treating throat discomfort caused by endotracheal intubation under general anesthesia for gastrointestinal tumor diseases.

[0013] The present invention has a wide range of applications, a safe formula, a sweet aftertaste, and low irritation. The formula uses traditional Chinese medicines that are both medicinal and edible, resulting in a simple flavor profile. However, the improved formula is different from previous products. Clinical observations have shown no significant adverse reactions in patients undergoing gastrointestinal tumor surgery, who have the weakest gastrointestinal function. The formula uses Pueraria root as the main ingredient, focusing on protecting and restoring gastrointestinal function without using any overly sweet, cool, or irritating drugs. The formula has a sweet aftertaste, is highly acceptable to patients, is safe, and has a wide range of applications.

[0014] Furthermore, the throat discomfort includes dry throat, sore throat, itchy throat, foreign body sensation or difficulty swallowing.

[0015] The present invention also provides a medicine for treating complications after endotracheal intubation for gastrointestinal tumor diseases, comprising the above-mentioned traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases and pharmaceutically acceptable excipients.

[0016] Preferably, the dosage form of the drug is granules, pills, capsules, Chinese herbal decoctions, decoctions, tablets, tea bags, suspensions, powders or oral liquids. More preferably, the dosage form of the drug is tea.

[0017] The present invention also provides a method for preparing the above-mentioned medicine for treating complications after endotracheal intubation for gastrointestinal tumor diseases in the form of a tea, comprising the following steps:

[0018] Step 1: Weigh the raw materials according to the weight ratio and conduct authenticity identification and moisture test (≤12%) according to the standards of the "Chinese Pharmacopoeia". Then, clean the process, which requires that the monk fruit be shelled and the pulp be taken out, and the deteriorated particles be manually picked out. The chrysanthemum is passed through a 6-mesh sieve to remove impurities from the peduncles. The kudzu root is dusted with high-pressure air. The pistachio is manually sorted to remove empty shells.

[0019] Step 2: Place the API purified in step 1 into a universal grinder for coarse crushing, equipped with a 10-mesh screen, first process the hard medicinal materials Pueraria root, Momordica grosvenori, and Sterculia lychnophora in sequence, and then crush the chrysanthemum medicinal material separately to prevent fiber entanglement. The coarse crushing particle size is controlled to 2-5 mm particles accounting for ≥90%;

[0020] Step 3: The crude drug substance obtained in step 2 is put into a V-type mixer and mixed evenly, using a forward and reverse mixing method for 30 minutes, and the mixing uniformity is controlled to be ≤5% of the HPLC fingerprint RSD;

[0021] Step 4: The API mixed in step 3 is packaged into corn fiber non-woven fabric at 10 g / bag using an automatic granule packaging machine, and the edges are hot-pressed and sterilized by irradiation at 180°C ± 5°C. The packaged medicine bags are then double-packaged, with the inner packaging being a single-package aluminum foil moisture-proof bag with an oxygen permeability of less than 0.5cc / m²·day, and the outer packaging being a color-printed composite film bag with the production batch number and shelf life printed on the outside of the composite film bag.

[0022] Preferably, the temperature resistance of the corn fiber non-woven fabric in step 4 is 120° C.; the irradiation sterilization is performed by irradiating with cobalt 60 gamma rays at a dose of 8 kGy, so that the total aerobic bacterial count of the microorganisms is controlled to be less than 1000 cfu / g.

[0023] The beneficial effects produced by the technical solution of the present invention are as follows:

[0024] (1) The Chinese medicine composition provided by the present invention is composed of Chinese medicinal materials with medicinal and edible properties, including chrysanthemum, monk fruit, kudzu root, and pterostilbene. Pterostilbene is sweet and cool and moisturizes the throat, monk fruit clears heat, moistens the lungs, and resolves phlegm, relieves sore throat and detoxifies, chrysanthemum clears heat and dispels wind, and kudzu root clears heat and promotes fluid production, while also strengthening the spleen and stomach. In the present invention, kudzu root is the main ingredient and has a high proportion in this prescription. Unlike other Chinese patent medicines for sore throat, this prescription focuses on the method of strengthening the body and promoting fluid production. It not only clears heat, promotes fluid production and moisturizes the throat, but also harmonizes the spleen and stomach. Compared with other simple sore throat granules, its efficacy is more lasting. Its main component, puerarin, has been found through microbial sequencing and metabolomics technology to restore the colon length of mice with ulcerative colitis and reduce colonic crypt damage. It can also inhibit the concentration of proinflammatory cytokines IL-1β, IL-6, and TNF-α, reduce fecal water content, improve diarrhea, and alleviate colitis. This study confirmed that puerarin can improve diarrhea, accelerated gastrointestinal motility, and visceral hypersensitivity in a rat model of diarrhea-predominant irritable bowel syndrome, which is related to its ability to alter the proportion of neurons and their subtypes in the colonic myenteric plexus and restore intestinal nerve homeostasis. The combined use of these four drugs has the effects of moistening the throat, promoting salivation, quenching thirst, and relieving sore throat. Clinical observations have confirmed that it can effectively relieve postoperative symptoms such as sore throat and dry throat, prevent lung infections, protect spleen and stomach function, and promote rapid postoperative recovery.

[0025] (2) The four herbs used in the Chinese medicine composition of the present invention are all commonly used Chinese medicines in clinical practice. They are inexpensive and of good quality, and have definite efficacy. Timely and early use can improve the patient's throat discomfort symptoms, reduce irritating cough and sputum, prevent the occurrence of lung infection and nosocomial infection, and promote the patient's rapid recovery, which has good economic and social benefits. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all the embodiments. Therefore, the following detailed description of the embodiments provided by the present invention is not intended to limit the scope of the invention claimed for protection, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0027] The present embodiment is for the inventor to summarize more than 60 years of clinical diagnosis and treatment of perioperative period of Chinese medicine differentiation of treatment experience, as well as rich surgical postoperative Chinese medicine conditioning experience, it is believed that postoperative patients with qi deficiency and qi stagnation coexist, spleen and stomach function is not restored under the influence of surgery and general anesthesia, spleen is the foundation of acquired constitution, all postoperative rehabilitation conditioning will focus on the maintenance of spleen and stomach, so the present invention adopts the medicine composition of medicine and food homology. And the present invention is observed by standard clinical trials, reviewed by the ethics committee, and randomized controlled trials are carried out. Test data show that the present invention has a good improvement effect on dry throat, thirst, sore throat, and foreign body sensation in patients after tracheal general anesthesia for gastrointestinal tumor diseases. In addition, the drug composition of the present invention fully considers the mouthfeel and the constitution of the postoperative crowd, pays attention to the scope of application of the medicine and promotion, so the present invention is sweet in taste and is widely praised by patients.

[0028] The specific implementation is as follows:

[0029] A traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases is composed of the following raw medicinal materials: momordica grosvenori, chrysanthemum, kudzu root and pterostilbene.

[0030] Luo Han Guo (Sheng Guo) is the dried fruit of the Cucurbitaceae plant, Momordica grosvenori. It is sweet and cooling in nature, and enters the lung and large intestine meridians. It has the effects of clearing heat and moistening the lungs, relieving sore throat and relieving pain, and promoting bowel movements. Luo Han Guo contains triterpenoid glycosides (natural sweeteners such as mogroside), flavonoids (flavonoids with strong antioxidant properties), and the mogroflavin D-mannitol. It is also rich in sugars such as glucose and fructose, as well as over 20 trace elements such as manganese, iron, and nickel, as well as nutrients such as protein, vitamins C, and E. These ingredients work together to clear lung heat, moisten the throat, and promote bowel movements.

[0031] Chrysanthemum is the complete flower cluster of the plant chrysanthemum after drying, including petals and pistil. bitter taste , sweet, slightly cold in nature, enters the lung and liver meridians. Calming the liver Improve eyesight, Clears heat and detoxifies It has an inhibitory effect on common pathogens such as Staphylococcus aureus and Escherichia coli, as well as skin fungi. It is also antiviral, can dilate coronary arteries and increase blood flow, but will increase myocardial oxygen consumption, and can assist in lowering blood pressure, shortening bleeding time, reducing fever, and having anti-inflammatory and sedative effects.

[0032] Sterculia lycopersicum (Pangdahai) is the dried mature seed of the Sterculia lycopersicum plant, a member of the Sterculiaceae family. It is sweet and cold in nature, and enters the lung and large intestine meridians. It has the benefits of relieving sore throats, moistening the intestines and promoting bowel movements, and clearing heat and moistening the lungs. It contains prangin (a substance that helps soothe the throat), and the pericarp contains galactose (a natural sugar) and pentose (a carbohydrate component). These ingredients work together to clear heat and moisten the lungs, relieve throat discomfort, and promote bowel movements.

[0033] Pueraria root is the dried root of the leguminous plant Pueraria lobata. It is sweet, pungent, and cooling in nature, and enters the spleen, stomach, and lung meridians. It has the effects of relieving muscle tension, reducing fever, promoting fluid production, and clearing rashes. It contains a variety of active ingredients, including flavonoids (such as the well-known puerarin), coumarins, pueraria alcohol, and starch. Pueraria root has a long history of use in my country, first mentioned in the Shennong's Herbal Classic. The book states that "it is sweet and mild in nature, originates from rivers and valleys, and treats thirst, severe fever, vomiting, and other numbness, and it can also raise yin qi and detoxify." Pueraria root has the effects of relieving muscle tension, reducing fever, promoting fluid production, clearing rashes, raising yang and stopping diarrhea, dredging meridians, and detoxifying alcohol. It is used to treat cardiovascular and cerebrovascular diseases, diabetes, respiratory and orthopedic diseases, Alzheimer's disease, cancer, and liver damage. Modern pharmacological research has shown that it has pharmacological effects such as lowering blood pressure, protecting the heart, combating atherosclerosis, combating sugar, protecting nerves, improving osteoporosis, fighting cancer, detoxifying alcohol, protecting the liver, and inhibiting inflammatory factors.

[0034] Puerarin, the main component of Pueraria root, has been reported in modern literature using microbial sequencing and metabolomics techniques to explore the protective mechanism of puerarin against ulcerative colitis. It is believed that puerarin intervention can restore colon length and reduce colonic crypt damage in mice with ulcerative colitis; it can also inhibit the concentrations of proinflammatory cytokines IL-1β, IL-6, and TNF-α, reduce fecal water content, improve diarrhea, and alleviate colitis. Animal experiments have confirmed that puerarin administration can improve symptoms such as diarrhea, accelerated gastrointestinal motility, and visceral hypersensitivity in a rat model of diarrhea-predominant irritable bowel syndrome. This is related to its ability to alter the proportion of neurons and their subtypes in the colonic myenteric plexus and restore enteric neural homeostasis.

[0035] As a preferred embodiment, the traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases is composed of the following raw materials in parts by mass: 36-45 parts of Pueraria root, 26-35 parts of Sterculia lychnophora, 5-15 parts of Momordica grosvenori, and 16-25 parts of Chrysanthemum.

[0036] As a preferred embodiment, the traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases is composed of the following raw materials in parts by mass: 38-43 parts of Pueraria root, 28-33 parts of Sterculia lychnophora, 7-13 parts of Momordica grosvenori, and 18-23 parts of Chrysanthemum.

[0037] As a preferred embodiment, the traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases is composed of the following raw materials in parts by mass: 40 parts of Pueraria root, 30 parts of Sterculia lychnophora, 10 parts of Momordica grosvenori, and 20 parts of Chrysanthemum.

[0038] The present invention provides use of the traditional Chinese medicine composition in treating throat discomfort caused by general anesthesia and endotracheal intubation for gastrointestinal tumor diseases.

[0039] As a preferred embodiment, the throat discomfort includes dry throat, sore throat, itchy throat, foreign body sensation or difficulty swallowing.

[0040] The present invention also provides a medicine for treating complications after endotracheal intubation for gastrointestinal tumor diseases, comprising the above-mentioned traditional Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases and pharmaceutically acceptable excipients.

[0041] As a preferred embodiment, the dosage form of the drug is granules, pills, capsules, Chinese herbal decoctions, decoctions, tablets, tea bags, suspensions, powders or oral liquids. As a more preferred embodiment, the dosage form of the drug is tea.

[0042] The present invention also provides a method for preparing the above-mentioned medicine for treating complications after endotracheal intubation for gastrointestinal tumor diseases in the form of a tea, comprising the following steps:

[0043] Step 1: Weigh the raw materials according to the weight ratio and conduct authenticity identification and moisture test (≤12%) according to the standards of the "Chinese Pharmacopoeia". Then, clean the process, which requires that the monk fruit be shelled and the pulp be taken out, and the deteriorated particles be manually picked out. The chrysanthemum is passed through a 6-mesh sieve to remove impurities from the peduncles. The kudzu root is dusted with high-pressure air. The pistachio is manually sorted to remove empty shells.

[0044] Step 2: Place the API purified in step 1 into a universal grinder for coarse crushing, equipped with a 10-mesh screen, first process the hard medicinal materials Pueraria root, Momordica grosvenori, and Sterculia lychnophora in sequence, and then crush the chrysanthemum medicinal material separately to prevent fiber entanglement. The coarse crushing particle size is controlled to 2-5 mm particles accounting for ≥90%;

[0045] Step 3: The crude drug substance obtained in step 2 is put into a V-type mixer and mixed evenly, using a forward and reverse mixing method for 30 minutes, and the mixing uniformity is controlled to be ≤5% of the HPLC fingerprint RSD;

[0046] Step 4: The API mixed in step 3 is packaged into corn fiber non-woven fabric at 10 g / bag using an automatic granule packaging machine, and the edges are hot-pressed and sterilized by irradiation at 180°C ± 5°C. The packaged medicine bags are then double-packaged, with the inner packaging being a single-package aluminum foil moisture-proof bag with an oxygen permeability of less than 0.5cc / m²·day, and the outer packaging being a color-printed composite film bag with the production batch number and shelf life printed on the outside of the composite film bag.

[0047] As a preferred embodiment, the temperature resistance of the corn fiber non-woven fabric in step 4 is 120° C.; the irradiation sterilization is performed by irradiating with cobalt 60 gamma rays at a dose of 8 kGy to control the total aerobic bacterial count of microorganisms to less than 1000 cfu / g.

[0048] The present invention is further described in detail below in conjunction with specific embodiments:

[0049] Example 1

[0050] This Example 1 provides a drug for treating complications after tracheal surgery for gastrointestinal tumors. The raw materials of the Chinese medicinal formula are prepared according to the following mass parts: 36 parts of Pueraria root, 26 parts of Sterculia lychnophora, 5 parts of Momordica grosvenori, and 16 parts of Chrysanthemum. The preparation method of this Example 1 is as follows:

[0051] Step 1: Weigh the raw materials according to the weight ratio and conduct authenticity identification and moisture test (≤12%) according to the standards of the "Chinese Pharmacopoeia". Then, clean the process, which requires that the monk fruit be shelled and the pulp be taken out, and the deteriorated particles be manually picked out. The chrysanthemum is passed through a 6-mesh sieve to remove impurities from the peduncles. The kudzu root is dusted with high-pressure air. The pistachio is manually sorted to remove empty shells.

[0052] Step 2: Place the API purified in step 1 into a universal grinder for coarse crushing, equipped with a 10-mesh screen, first process the hard medicinal materials Pueraria root, Momordica grosvenori, and Sterculia lychnophora in sequence, and then crush the chrysanthemum medicinal material separately to prevent fiber entanglement. The coarse crushing particle size is controlled to 2-5 mm particles accounting for ≥90%;

[0053] Step 3: The crude drug substance obtained in step 2 is put into a V-type mixer and mixed evenly, using a forward and reverse mixing method for 30 minutes, and the mixing uniformity is controlled to be ≤5% of the HPLC fingerprint RSD;

[0054] Step 4: The API mixed in step 3 is packaged into corn fiber non-woven fabrics at 10 g / bag using an automatic granule packaging machine, hot-pressed at 180°C ± 5°C, and sterilized by irradiation.

[0055] Step 5: Double-package the medicine bags prepared in step 4. The inner packaging is a single-package aluminum foil moisture-proof bag with an oxygen permeability of less than 0.5cc / m²·day, and the outer packaging is a color-printed composite film bag with the production batch number and shelf life printed on the outside of the composite film bag.

[0056] Example 2

[0057] This Example 2 provides a Chinese medicine composition for treating complications after tracheal surgery for gastrointestinal tumors. The Chinese medicine ingredients are prepared in the following proportions: 38 parts of Pueraria root, 28 parts of Sterculia lychnophora, 7 parts of Momordica grosvenori, and 18 parts of Chrysanthemum. The preparation method of this Example 2 is the same as that of Example 1.

[0058] Example 3

[0059] This Example 3 provides a Chinese medicine composition for treating complications after tracheal surgery for gastrointestinal tumors. The Chinese medicine ingredients are prepared in the following proportions: 40 parts of Pueraria root, 30 parts of Sterculia lychnophora, 10 parts of Momordica grosvenori, and 20 parts of Chrysanthemum. The preparation method of this Example 3 is the same as that of Example 1.

[0060] Example 4

[0061] This Example 4 provides a Chinese medicine composition for treating complications after tracheal surgery for gastrointestinal tumors. The Chinese medicine ingredients are prepared in the following proportions: 43 parts of Pueraria root, 33 parts of Sterculia lychnophora, 13 parts of Momordica grosvenori, and 23 parts of Chrysanthemum. The preparation method of this Example 4 is the same as that of Example 1.

[0062] Example 5

[0063] This Example 5 provides a Chinese medicine composition for treating complications after tracheal surgery for gastrointestinal tumors. The Chinese medicine ingredients are prepared in the following parts by weight: 45 parts of Pueraria root, 35 parts of Sterculia lychnophora, 15 parts of Momordica grosvenori, and 25 parts of Chrysanthemum. The preparation method of this Example 5 is the same as that of Example 1.

[0064] To further observe the effectiveness of the Chinese medicine composition of the present application, this study applied the Chinese medicine composition of the present invention to the comprehensive improvement of symptoms such as throat discomfort and dry mouth in patients with gastrointestinal tumors after surgery, and achieved good results. This study has been approved by the Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine (Approval No.: BF2022-186-01).

[0065] 1. Research subjects

[0066] The cases included in this study were all patients who underwent laparoscopic gastrointestinal tumor surgery under endotracheal intubation and general anesthesia in Guangdong Provincial Hospital of Traditional Chinese Medicine from March to July 2023, and a total of 76 patients who met the inclusion criteria were screened.

[0067] 2. Inclusion and exclusion criteria

[0068] 2.1 Inclusion criteria:

[0069] (1) Patients undergoing elective laparoscopic radical resection of gastric or colorectal cancer;

[0070] (2) The surgical anesthesia method was general anesthesia with endotracheal intubation;

[0071] (3) Age 18–70 years old;

[0072] (4) Have full cognitive and behavioral abilities;

[0073] (5) Volunteer to participate in this study and sign the informed consent form.

[0074] 2.2 Exclusion criteria:

[0075] (1) Patients with serious primary diseases of the heart, liver, lung, kidney, hematopoietic system, and endocrine system;

[0076] (2) Severe complications occur after surgery, such as: patients with massive gastrointestinal bleeding, severe digestive fistula; pregnant and lactating women; patients with mental illness.

[0077] 3. Observation indicators

[0078] (1) Throat pain severity score: A visual pain simulation score is used to represent the pain severity with 11 numbers from 0 to 10, where 0 represents no pain and 10 represents the worst pain. As the number increases, the pain gradually worsens. Choose a number that represents your pain based on your own throat pain condition.

[0079] (2) Pharyngeal pain and associated symptoms score: The primary and secondary symptoms are divided into five dimensions: pharyngeal pain, dry throat, itchy throat, foreign body sensation, and dysphagia. 0 points indicate no symptoms, 1 point indicates mild, 2 points indicate moderate, and 3 points indicate severe. The higher the score, the more severe the pharyngeal symptom.

[0080] (3) Oral dryness grading evaluation criteria: The degree of dry mouth is scored on a scale of 0-4. Grade 0 means no dry mouth symptoms, Grade 1 means suspected dry mouth, with mild dry mouth when waking up from sleep, Grade 2 means continuous mild dry mouth, which does not affect eating and speaking, Grade 3 means continuous moderate dry mouth, requiring drinking water when eating or speaking, and Grade 4 means continuous severe dry mouth, with a burning sensation in the mouth, difficulty swallowing and chewing, and the need to carry a water bottle with you.

[0081] 4. Data Analysis

[0082] Data were analyzed using SPSS 19.0. The severity of pharyngeal pain, dry throat, itchy throat, foreign body sensation, and dysphagia was expressed as mean ± standard deviation (x ± s). The two groups were compared using an independent sample t-test. P < 0.05 was considered statistically significant.

[0083] 5. Research Plan

[0084] 5.1 Grouping

[0085] Of the 76 patients who met the diagnostic criteria, 38 were randomly assigned to the experimental group and the control group using a random number table. Two patients in the experimental group experienced nausea and vomiting 6 and 8 hours after surgery, respectively, and were subsequently discontinued from the trial. One patient in the control group also experienced nausea and vomiting 8 hours after surgery, also discontinued from the trial and was subsequently discontinued. A total of 73 patients were enrolled, including 36 in the experimental group and 37 in the control group.

[0086] (1) Experimental group: 19 males and 17 females; aged 26-69 (58.0±10.3) years; disease type: 8 cases of gastric cancer and 28 cases of colorectal cancer;

[0087] (2) Control group: 17 males and 20 females; aged 37-70 (56.9±10.1) years; disease types: 9 cases of gastric cancer and 28 cases of colorectal cancer;

[0088] There was no statistically significant difference in age, gender, disease type and other general information between the two groups (P>0.05), indicating that the two groups were comparable.

[0089] 5.2 Treatment

[0090] The clinical pathway for gastrointestinal surgery points out that all postoperative patients should resume oral rehydration as soon as possible, provided that there is no nausea or vomiting, but there are no clear requirements for the specific time, amount and time interval for drinking water. For patients whose vital signs are stable after surgery, whose consciousness is fully awake, whose muscle strength has recovered to level V, whose swallowing reflex has recovered and who have no nausea or vomiting, on the basis of routine treatment and nursing, the control group: drink warm boiled water orally starting from 6 hours after surgery, once every 2 hours, 20 mL each time, until 48 hours after surgery. The experimental group: place the tea prepared in Example 3 in 250 mL of warm boiled water, soak for 30 minutes, drink it starting from 6 hours after surgery, once every 2 hours, 20 mL each time, until 48 hours after surgery. Both groups of patients drink from 00:00 to 06:00 at night, depending on the situation. They can drink if they feel dry mouth and thirsty, but it is not mandatory. However, they must drink it at two time points: 6 hours and 8 hours after surgery.

[0091] 6. Research Results

[0092] 6.1 Comparison of VAS throat pain between the two groups (see Table 1)

[0093] Table 1 Comparison of VAS throat pain between the two groups of patients

[0094]

[0095] As shown in Table 1, the postoperative throat pain scores of both groups decreased over time. At 8, 12, 24, and 48 hours after surgery, the experimental group showed significantly better improvement in throat pain than the control group (P < 0.05). Among the patients in the experimental group, after taking the drug 6 hours after surgery, the effect was apparent 8 hours after surgery, with the greatest improvement in throat pain 12 hours after surgery and virtually no pain at 48 hours after surgery.

[0096] 6.2 Comparison of overall scores of sore throat and associated symptoms (see Table 2)

[0097] Table 2 Overall scores of pharyngeal pain and associated symptoms in the two groups of patients

[0098]

[0099] As shown in Table 2, the overall scores of postoperative pharyngitis and associated symptoms decreased over time in both groups. The overall improvement in pharyngitis and associated symptoms in the experimental group was significantly better than that in the control group at 8, 12, 24, and 48 hours after surgery (P < 0.05). After the experimental group consumed the drug 6 hours after surgery, the effect was apparent 8 hours after surgery. The overall improvement in pharyngitis and associated symptoms was greatest 12 hours after surgery, and the pharyngitis and associated symptoms had essentially disappeared after 12 hours.

[0100] 6.3 Comparison of dry throat between the two groups of patients (see Table 3)

[0101] Table 3 Comparison of dry throat between the two groups of patients

[0102]

[0103] As shown in Table 3, the dry throat scores of the two groups of patients decreased over time. At 8h, 12h, 24h and 48h after the operation, the improvement of dry throat in the test group was better than that in the control group, and the difference was statistically significant (P<0.05). The patients in the test group could see the effect after 6h of drinking the drug of the application, and the improvement was the largest at 8h after the operation. The dry throat symptoms basically disappeared at 12h after the operation.

[0104] 6.4 Comparison of foreign body sensation in throat between the two groups of patients (see Table 4)

[0105] Table 4 Comparison of foreign body sensation in throat between the two groups of patients

[0106]

[0107] As shown in Table 4, the improvement of foreign body sensation in throat in the test group was better than that in the control group at 24h and 48h after the operation, and the difference was statistically significant (P<0.05). The patients in the test group could see the effect after 6h of drinking the drug of the application, and the improvement was the largest at 24h after the operation. The foreign body sensation in throat symptoms basically disappeared at 24h after the operation.

[0108] 6.5 Comparison of dry mouth between the two groups of patients (see Table 5)

[0109] Table 5 Comparison of dry mouth between the two groups of patients

[0110]

[0111] As shown in Table 5, the improvement of dry mouth in the test group was better than that in the control group at 12h, 24h and 48h after the operation, and the difference was statistically significant (P<0.05). The patients in the test group could see the effect after 6h of drinking the drug of the application, and the improvement was the largest at 12h after the operation. The dry mouth symptoms basically disappeared at 24h after the operation.

[0112] Conclusion: Postoperative throat pain and discomfort improved over time in both groups. The experimental group showed significantly better improvement in throat pain and discomfort at 8, 12, 24, and 48 hours after surgery than the control group (P < 0.05). Patients in the experimental group who consumed the drug 6 hours after surgery experienced significant improvement by 8 hours, with the greatest improvement in throat pain and discomfort 12 hours after surgery. Symptoms of throat pain and discomfort essentially disappeared 24 to 48 hours after surgery. Dry mouth improved significantly in the experimental group at 12, 24, and 48 hours after surgery than in the control group (P < 0.05). Patients who consumed the drug 6 hours after surgery experienced significant improvement in dry mouth by 12 hours after surgery, with the greatest improvement, and the dry mouth symptoms essentially disappeared 24 hours after surgery.

[0113] In conclusion, if patients with gastrointestinal tumors start drinking the drug 6 hours after endotracheal intubation and general anesthesia, it can effectively improve throat discomfort and dry mouth symptoms within 24 hours after surgery, and is worthy of clinical promotion and application.

[0114] Typical cases:

[0115] Case 1: Ma, female, 54 years old, was initially diagnosed with colon malignancy on March 22, 2023, and underwent laparoscopic sigmoid colectomy under general anesthesia with endotracheal intubation on March 27. Six hours after the operation, the tea bag of the medicinal and edible composition in Example 3 of the present invention was used for brewing and taking, 1 dose per day, for 48 hours after the operation. After taking it, the patient's throat pain score dropped from 5 points to 4 points, 2 points, 1 point, and 1 point at 8 hours, 12 hours, 24 hours, and 48 hours after the operation, respectively; the overall score of postoperative throat pain and the accompanying symptoms such as dry throat, itchy throat, foreign body sensation, and dysphagia dropped from 3 points to 1 point 48 hours after the operation.

[0116] Case 2: Feng, female, 61 years old, was initially diagnosed with rectal malignant tumor on April 10, 2023. On April 12, she underwent laparoscopic anterior rectal resection under general anesthesia with endotracheal intubation. Six hours after the operation, the tea bag of the medicinal and edible composition in Example 3 of the present invention was used for brewing and taking, 1 dose per day, for 48 hours after the operation. After taking it, the patient's throat pain score dropped from 4 points to 3 points, 1 point, 0 points, and 0 points at 8 hours, 12 hours, 24 hours, and 48 hours after the operation, respectively; the overall score of postoperative throat pain and the accompanying symptoms such as dry throat, itchy throat, foreign body sensation, and dysphagia dropped from 2 points to 0 points 24 hours after the operation.

[0117] Case 3: Mr. Fu, male, 68 years old, was initially diagnosed with gastric malignant tumor on May 7, 2023. On April 12, he underwent total gastrectomy with esophagojejunostomy under general anesthesia with endotracheal intubation. Six hours after the operation, the tea bag of the medicinal and edible composition in Example 3 of the present invention was used for brewing and taking, 1 dose per day, for 48 hours after the operation. After taking it, the patient's throat pain score dropped from 6 points to 5 points, 3 points, 1 point, and 1 point at 8 hours, 12 hours, 24 hours, and 48 hours after the operation, respectively; the overall score of postoperative throat pain and the accompanying symptoms such as dry throat, itchy throat, foreign body sensation, and dysphagia dropped from 3 points to 1 point 48 hours after the operation.

[0118] Case 4: Deng, female, 68 years old, was initially diagnosed with rectal malignant tumor on May 22, 2023. On May 25, she underwent laparoscopic anterior rectal resection under general anesthesia with endotracheal intubation. Six hours after the operation, the tea bag of the medicinal and edible composition in Example 3 of the present invention was used for brewing and taking, 1 dose per day, for 48 hours after the operation. After taking it, the patient's throat pain score dropped from 3 points to 3 points, 1 point, 1 point, and 0 points at 8 hours, 12 hours, 24 hours, and 48 hours after the operation, respectively; the overall score of postoperative throat pain and the accompanying symptoms such as dry throat, itchy throat, foreign body sensation, and dysphagia dropped from 3 points to 0 points 48 hours after the operation.

[0119] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases, characterized in that: The invention is composed of the following raw materials in parts by weight: 36-45 parts of kudzu root, 26-35 parts of sterculia lychnophora, 5-15 parts of momordica grosvenori and 16-25 parts of chrysanthemum.

2. The Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 38-43 parts of kudzu root, 28-33 parts of sterculia lychnophora, 7-13 parts of momordica grosvenori and 18-23 parts of chrysanthemum.

3. The Chinese medicine composition for treating complications after endotracheal intubation for gastrointestinal tumor diseases according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 40 parts of kudzu root, 30 parts of sterculia lychnophora, 10 parts of momordica grosvenori and 20 parts of chrysanthemum.

4. Use of the Chinese medicine composition according to any one of claims 1 to 3 in treating throat discomfort caused by general anesthesia and endotracheal intubation for gastrointestinal tumor diseases.

5. The use according to claim 4, characterized in that The throat discomfort includes dry throat, sore throat, itchy throat, foreign body sensation or difficulty swallowing.

6. A drug for treating complications after endotracheal intubation for gastrointestinal tumor diseases, characterized in that: The invention comprises the traditional Chinese medicine composition for treating complications after endotracheal intubation according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

7. The drug for treating complications after endotracheal intubation for gastrointestinal tumor diseases according to claim 6, characterized in that: The dosage form of the medicine is granules, pills, capsules, Chinese medicine decoctions, decoctions, tablets, bagged tea preparations, suspensions, powders or oral liquids.

8. The method for preparing the drug for treating complications after endotracheal intubation for gastrointestinal tumor diseases according to claim 6 or 7, characterized in that: The medicine is a bagged tea preparation, and its preparation method is as follows: Step 1: weigh the raw material according to the weight ratio and purify it; Step 2: coarsely crushing the API prepared in step 1; Step 3, mixing the crude drug substance obtained in step 2 uniformly; Step 4: The raw materials mixed evenly in step 3 are divided into subpackages, irradiated and sterilized, and packaged to obtain the product.

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