Traditional Chinese medicine composition for promoting postoperative intestinal function recovery of abdominal operation patient as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for promoting postoperative intestinal function recovery of an abdominal operation patient and a preparation method and application thereof, and belongs to the field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 168 to 254 parts of clove, 168 to 254 parts of fennel, 84 to 126 parts of costus root, 50 to 76 parts of combined spicebush root, 50 to 76 parts of nutgrass galingale rhizome, 50 to 76 parts of officinal magnolia bark and 8 to 14 parts of borneol. The invention further provides a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is applied to the Shenque acupoint for external use, clinical compliance and safety are improved, clinical data show that the traditional Chinese medicine composition can remarkably shorten exhaust time and improve postoperative intestinal dysfunction, and the traditional Chinese medicine composition has good popularization and application prospects.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for promoting the recovery of intestinal function in patients after abdominal surgery, belonging to the field of traditional Chinese medicine. Background Art

[0002] After abdominal surgery, patients often suffer from postoperative ileus (POI), which is a temporary inhibition of gastrointestinal function caused by various factors such as surgical trauma, anesthetic drugs, and opioid analgesics. Currently, the drugs for promoting the recovery of intestinal function in patients after abdominal surgery are mainly oral, for example: 1. Prokinetic drugs Prucalopride: Prucalopride is a highly selective 5 - hydroxytryptamine 4 receptor agonist that can enhance gastrointestinal motility. Studies have shown that prucalopride can significantly shorten the time of the first defecation and the first flatus after surgery, and reduce the incidence of POI. However, another multi - center, double - blind, placebo - controlled study found that although prucalopride can shorten the time of the first defecation, it has no significant effect on the incidence of POI and the length of hospital stay.

[0003] Mosapride: Mosapride is also a 5 - hydroxytryptamine 4 receptor agonist, mainly used to treat gastrointestinal motility disorder diseases. Although there is currently a lack of large - scale clinical trials directly evaluating its effect on the recovery of intestinal function after abdominal surgery, its potential role in improving gastrointestinal motility makes it a potentially beneficial supplement for postoperative recovery.

[0004] 2. Opioid receptor antagonists Alvimopan: Alvimopan is a peripheral μ - opioid receptor antagonist that can block the inhibitory effect of opioids on the gastrointestinal tract without affecting the central analgesic effect. Multiple studies have shown that alvimopan can significantly shorten the time of the first flatus, defecation and the length of hospital stay after surgery, and reduce the incidence of POI - related complications. However, alvimopan has not been approved for clinical use in China and Europe.

[0005] Naloxone: Naloxone is a non - selective opioid receptor antagonist that can be administered by intravenous injection or orally. Although its application in the recovery of postoperative gastrointestinal function is less, some studies have shown that naloxone can shorten the recovery time of postoperative gastrointestinal function.

[0006] 3. Other drugs Cimetidine: Cimetidine is an H2 receptor antagonist that can reduce gastrointestinal irritation by inhibiting gastric acid secretion, and thus may have a positive effect on the recovery of postoperative gastrointestinal function.

[0007] Coffee: Caffeine in coffee can dilate vascular smooth muscle and reduce inflammatory responses. Multiple studies have found that coffee can reduce the incidence of POI.

[0008] Simethicone: Simethicone can merge the bubbles in the intestine and promote gas excretion. However, a multi-center, double-blind, placebo-controlled study did not find it to have a significant impact on the time of the first postoperative flatulence, defecation, and length of hospital stay.

[0009] Gastrografin: Gastrografin is a water-soluble contrast agent that can increase the fluid volume in the intestine, reduce intestinal wall edema, and improve intestinal motility. However, multiple studies and meta-analyses have shown that Gastrografin is not significantly effective in preventing or treating POI.

[0010] 4. Traditional Chinese Medicine Wuda Granule: Wuda Granule is a traditional Chinese medicine compound preparation composed of ginseng, betel nut, peach kernel, lindera root, and amomum fruit. Studies have shown that Wuda Granule can significantly improve the weakened gastrointestinal motility after abdominal surgery and promote the recovery of postoperative gastrointestinal function.

[0011] 5. Analgesic Drugs Non-steroidal anti-inflammatory drugs (NSAIDs): NSAIDs can reduce the synthesis of inflammatory mediators by inhibiting the cyclooxygenase pathway, alleviate the postoperative inflammatory response, and thus facilitate the recovery of postoperative gastrointestinal function. A Meta-analysis showed that NSAIDs can shorten the time of postoperative flatulence and defecation.

[0012] Dexamethasone: Dexamethasone is a glucocorticoid that can reduce the concentration of postoperative inflammatory factors, improve the degree of postoperative abdominal distension, and promote the tolerance of liquid diet, thus promoting the recovery of gastrointestinal function.

[0013] Lidocaine: Lidocaine can reduce the production of complement and pro-inflammatory factors, inhibit the gastrointestinal inflammatory response, reduce the occurrence of postoperative intestinal obstruction, and directly inhibit the mesenteric sympathetic plexus, reducing the dosage of postoperative opioid drugs, thus promoting the recovery of postoperative gastrointestinal function.

[0014] 5. Other Treatment Measures Multimodal analgesia: The multimodal analgesia regimen can reduce the dosage of opioid drugs and their inhibitory effect on the gastrointestinal tract by combining multiple analgesic drugs and techniques, thus promoting the recovery of postoperative gastrointestinal function.

[0015] Early enteral nutrition: Early enteral nutrition can regulate the immune response, reduce the postoperative inflammatory response, and shorten the duration of POI.

[0016] With the popularization of the modern concept of enhanced recovery after surgery (ERAS), the recovery of intestinal function after surgery has become a key link in improving the quality of patient recovery and shortening the hospital stay. However, most of the current clinical drugs for intestinal function recovery are oral or invasive means, which are prone to cause adverse reactions and are not applicable to patients who are unable to take oral medications in the early postoperative period.

[0017] Currently, there are also reports on the external application of traditional Chinese medicine. For example, Ruan Mei, "The effect of traditional Chinese medicine acupoint application on the recovery of intestinal function after gastrointestinal surgery", Nursing and Rehabilitation, Volume 13, Issue 1, January 2014. It observed the effect of traditional Chinese medicine acupoint application on promoting the recovery of intestinal function after gastrointestinal surgery. The traditional Chinese medicine prescription disclosed in this literature is: Lindera aggregata 9g, Fructus Foeniculi 8g, Aurantii Fructus Immaturus 10g, Natrii Sulfas Exsiccatus 10g, Borneolum Syntheticum 3g, Areca catechu 9g, Rheum officinale 9g.

[0018] CN202310398562.5, Invention Title: A traditional Chinese medicine compound preparation for treating gastrointestinal dysfunction, its preparation method and application. It discloses a traditional Chinese medicine compound preparation for treating gastrointestinal dysfunction, which is made from the following medicinal materials: Magnolia officinalis, Fructus Aurantii Immaturus stir-fried with bran, Flos Caryophylli, and Fructus Foeniculi. It also discloses the preparation method and application of the traditional Chinese medicine compound preparation. The traditional Chinese medicine compound preparation can be used to prepare drugs for treating patients with gastrointestinal dysfunction and promoting intestinal function recovery, and can also be used in the preparation of drugs for treating liver cirrhosis complication diseases. This invention mainly treats through external treatment of traditional Chinese medicine, and the external application of traditional Chinese medicine preparation at acupoints or on the local skin can promote drug absorption.

[0019] CN201110003245.6, Invention Title: A preparation method of a stomachache plaster. It discloses a preparation method of a stomachache plaster. Dry and grind cloves, Aucklandia lappa, frankincense, Aquilaria sinensis, Cyperus rotundus, etc. into extremely fine powder, then grind borneol into fine powder and mix it evenly with the above medicinal powder. Then chop ginger and scallions and mash them into a paste, take the juice and mix it with the above medicinal powder to form a plaster. When having a stomachache, apply the plaster on the Shenque acupoint and fix it with adhesive tape.

[0020] CN202411086719.1, Invention Title: Disclosed is a traditional Chinese medicine composition for treating gastrointestinal dysfunction after abdominal surgery, its preparation method and application, belonging to the technical field of traditional Chinese medicine preparation; the traditional Chinese medicine composition includes fennel, mugwort leaf, magnolia bark, cinnamon, dried ginger, costus root, Chinese prickly ash, clove, nardostachys root and rhizome, dahurian angelica root and big rock salt; during preparation, first crush fennel, mugwort leaf, magnolia bark, cinnamon, dried ginger, costus root, Chinese prickly ash, clove, nardostachys root and rhizome, dahurian angelica root, and then mix the crushed medicine with big rock salt; after applying the prepared traditional Chinese medicine composition to gastrointestinal dysfunction after abdominal surgery, it is found that it has better curative effects in treating gastrointestinal functions, such as early exhaust and defecation of patients, abdominal distension and other accompanying symptoms, especially has certain advantages for symptoms such as abdominal pain, nausea, vomiting, etc. The formula of this application has a warm property of traditional Chinese medicine, and is suitable for syndromes such as yang deficiency and cold coagulation type after surgery, qi stagnation and abdominal distension, loss of appetite, fullness in the epigastric and abdominal regions, etc.; mugwort leaf, Chinese prickly ash, big rock salt, etc. have the effects of warming channels and dispelling cold and anti-infection, and the external application patch has a good effect; dahurian angelica root has a fragrance, enhances penetration, and can also relieve postoperative headache and abdominal distension. Its defect is that there are mostly drugs with a warm nature, which are not suitable for patients with damp-heat, yin deficiency, and postoperative fever and infection; there are no drugs for clearing heat and detoxifying and moistening dryness, and may not be suitable for those with constipation, dry mouth, and yellowish tongue coating and red tongue.

[0021] CN202411291281.0, Invention Title: A traditional Chinese medicine plaster for treating postoperative abdominal distension, its preparation method and application, relates to a traditional Chinese medicine plaster for treating postoperative abdominal distension, its preparation method and application. The traditional Chinese medicine plaster includes the following components, fennel, with a content of 70 - 80% of the total mass; clove, with a content of 5 - 9% of the total mass; immature bitter orange, with a content of 5 - 9% of the total mass; rhubarb, with a content of 5 - 9% of the total mass; borneol, with a content of 2 - 4% of the total mass. The traditional Chinese medicine plaster of the present invention is convenient to use, has a quick onset of action and good curative effects, and can effectively relieve and treat problems such as postoperative epigastric and abdominal fullness and stuffiness, stagnation in the middle energizer, and obstruction of the qi movement of the bowels caused by various reasons. This patent document is suitable for patients with qi stagnation and constipation type due to obstruction of the qi movement of the bowels after surgery, and has an obvious effect of "promoting qi downward and removing stagnation". Modern components (silver ions, vitamin E) can enhance antibacterial, anti-inflammatory, and tissue repair abilities. The sustained-release material improves the bioavailability and is conducive to clinical promotion. However, the formula disclosed in this document has a nature of traditional Chinese medicine that is relatively attacking and excessive, and is not suitable for patients with a weak constitution or those with severe deficiency of the spleen qi in the early postoperative stage. It contains rhubarb, and attention should be paid to skin irritation and possible side effects caused by long-term use when used externally. It is not applicable to those with severe physical weakness in the early postoperative stage, tendency to diarrhea, and those with an intestinal anastomosis that has just been completed and not healed. Moreover, for those containing rhubarb, the dosage and application concentration need to be strictly controlled to prevent excessive purgation or local irritation.

[0022] The TCM syndrome differentiation of postoperative intestinal function problems in abdominal surgery patients is mainly based on the overall concept and syndrome differentiation and treatment principles of TCM. Combining the specific symptoms, signs of the patients and the pathophysiological characteristics after surgery, comprehensive analysis and judgment are carried out. There are many types of syndrome differentiation, including: qi stagnation and blood stasis type, disharmony between the liver and stomach type, qi and blood deficiency type, internal accumulation of dampness and heat type, spleen and stomach yang deficiency type. Due to the complexity of the TCM syndrome differentiation types of postoperative intestinal function in abdominal surgery patients, there is currently no drug specifically for treating gastrointestinal dysfunction caused by yang deficiency of the stomach and spleen and yang deficiency of the spleen and stomach. Summary of the Invention

[0023] The purpose of the present invention is to provide a traditional Chinese medicine external application composition that can significantly promote the recovery of postoperative intestinal function in abdominal surgery patients, and propose its preparation method and medical use to make up for the deficiencies of current postoperative rehabilitation means.

[0024] The present invention provides a traditional Chinese medicine composition for promoting the recovery of postoperative intestinal function in abdominal surgery patients, which is characterized in that: it is prepared from the following raw materials in parts by weight: 168 - 254 parts of cloves, 168 - 254 parts of fennel, 84 - 126 parts of costus root, 50 - 76 parts of lindera aggregata, 50 - 76 parts of cyperus rotundus, 50 - 76 parts of magnolia officinalis, 8 - 14 parts of borneol.

[0025] Preferably, it is prepared from the following raw materials in parts by weight: 211 parts of cloves, 211 parts of fennel, 105 parts of costus root, 63 parts of lindera aggregata, 63 parts of cyperus rotundus, 63 parts of magnolia officinalis, 11 parts of borneol.

[0026] The traditional Chinese medicine composition of the present invention takes the raw drug powder of the raw materials, the extract of water or organic solvent as the active ingredient, and adds pharmaceutically acceptable excipients or auxiliary components to prepare a pharmaceutically common external preparation.

[0027] Among them, the excipient is honey.

[0028] Among them, the external preparation is ointment, cream, gel, patch, powder, paste, film, lotion, tincture, liniment, aerosol, spray, suppository, etc. The present invention also provides a preparation method of the above-mentioned traditional Chinese medicine composition for promoting the recovery of postoperative intestinal function in abdominal surgery patients, which includes the following steps: a. Weigh the raw materials in the respective weight ratios; b. Powder or extract with water or organic solvent, and then add pharmaceutically acceptable excipients or auxiliary components to prepare a pharmaceutically common external preparation.

[0029] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of an external drug for promoting the recovery of postoperative intestinal function in abdominal surgery patients.

[0030] Among them, the drug is used to treat Yangming deficiency-cold syndrome and gastrointestinal dysfunction caused by yang deficiency of the spleen and stomach.

[0031] Among them, the drug is used to relieve symptoms such as postoperative ileus, abdominal distension, constipation, and weakness in defecation.

[0032] Among them, the drug is administered to the Shenque acupoint.

[0033] Compared with compound prescriptions such as CN202310398562.5, the drug of the present invention highlights the triple strategies of "applying patches to the Shenque acupoint + warming yang and promoting qi movement + promoting transdermal penetration", and has stronger targeting and synergy. Compared with the drugs such as rhubarb and immature bitter orange used in CN202411291281.0 which are relatively attacking in nature, the drug of the present invention has mild properties, is suitable for postoperative patients with deficiency syndromes, and has higher safety.

[0034] "Synopsis of the Golden Chamber" points out that "after a serious illness, the deficiency and damage are the most severe". Postoperative recovery needs to take into account both "regulating the middle-jiao and strengthening the healthy qi" and "promoting qi movement and guiding stagnation". According to the theory of traditional Chinese medicine syndrome differentiation, after abdominal surgery, it is often "weakness of Yangming fu-organ qi, qi stagnation and damp obstruction". In the early postoperative stage, qi stagnation is the main manifestation, and the treatment should focus on "promoting qi movement first and assisting with warming yang". In the early postoperative period (0 - 3 days), the main manifestations of patients are abdominal distension, poor flatulence, stuffiness in the epigastrium, nausea, pale tongue with white coating, and deep and slow pulse. The main pathogenesis is qi stagnation and cold congelation, obstruction of the fu-organ qi, and injury of the spleen yang. The syndrome differentiation is mainly qi stagnation with cold congelation; in the middle postoperative period (3 - 7 days), the main manifestations of patients are obvious abdominal distension, unsmooth flatulence, constipation, and yellow and greasy tongue coating. The main pathogenesis is gradual resolution of qi stagnation, internal binding of fu-organ excess, or damp-heat stasis obstruction. The syndrome differentiation is mainly qi stagnation and fu-organ excess, accompanied by damp-heat stasis binding; in the postoperative recovery period (after 7 days), the main manifestations of patients are poor appetite, fatigue, loose stools, and pale tongue with thin coating. The main pathogenesis is weakness of the spleen and stomach and failure of qi movement to recover. The syndrome differentiation is mainly spleen deficiency, accompanied by mild dampness.

[0035] The traditional Chinese medicine composition of the present invention is based on classic traditional Chinese medicine works such as "Huangdi Neijing" and "Treatise on Febrile and Miscellaneous Diseases". After surgery, it mostly belongs to the syndrome of deficiency-cold of the spleen and stomach and qi stagnation and blood stasis. Qi movement is unsmooth, and cold pathogens invade internally, resulting in the failure of "the spleen ascending and the stomach descending", manifested as abdominal distension, constipation, difficulty in flatulence, nausea and vomiting, etc. Traditional Chinese medicine emphasizes "promoting qi movement first". Among external treatment methods, the Shenque acupoint (the center of the umbilicus) is especially the "root of the return and storage of primordial qi", and has the unique advantage of regulating the five zang-organs and six fu-organs and dredging the channels and collaterals. The traditional Chinese medicine composition of the present invention takes "warming yang and promoting qi movement" as the core, and is especially suitable for the syndrome of cold congelation and qi stagnation in the early postoperative period. The compatibility is reasonable, the properties of the medicine are warm but not dry, and it also has a certain property of promoting blood circulation. Containing honey, it can be used for transdermal absorption patches or external application dosage forms, and synergistically enhances the penetration power with borneol.

[0036] In the raw materials of the traditional Chinese medicine composition of the present invention, cloves and fennel are warm in nature and pungent in taste. When the two are combined, they can effectively disperse the cold pathogens in the spleen, stomach and liver meridians. Cloves can warm the middle-jiao and lower adverse qi. Its warm nature can disperse the cold coagulation in the middle-jiao and relieve symptoms such as cold pain in the stomach cavity and vomiting. Fennel is good at warming the liver and dispelling cold, and can relieve cold pain in the lower abdomen and abdominal pain due to hernia caused by cold coagulation in the liver meridian, so as to resolve the state of cold coagulation and restore the warming and circulation of yang qi. The two are used in combination to jointly warm the interior and dispel cold, promote qi flow and relieve pain, and are the monarch drugs. Aucklandia lappa can promote qi flow and relieve pain, strengthen the spleen and promote digestion, and focus on dredging qi stagnation in the spleen and stomach, and can improve symptoms such as fullness in the stomach cavity and loss of appetite; Magnolia officinalis can dry dampness, eliminate phlegm, lower qi and relieve fullness, and has significant effects on stuffiness and fullness in the abdomen and abdominal distension and constipation caused by dampness obstruction and qi stagnation in the middle-jiao; Cyperus rotundus can soothe the liver, regulate qi and relieve pain, mainly aiming at rib-side distending pain and emotional depression caused by liver qi stagnation. By dredging the liver qi and coordinating the operation of qi in the whole body, it breaks the pathological state of qi stagnation, makes the qi rise and fall orderly, and restores the normal function of the spleen and stomach in transportation and transformation. The combination of the three drugs can jointly dredge and regulate the triple energizer, regulate qi flow, eliminate accumulation and promote digestion, and are the ministerial drugs. Borneol: pungent, bitter, slightly cold, returning to the heart, spleen and lung meridians. Honey: sweet and flat, returning to the lung, spleen and large intestine meridians. The medicinal properties of this drug are sweet and flat, returning to the spleen meridian, tonifying the spleen qi, being able to both replenish the middle-jiao and relieve spastic pain, and has the effect of promoting granulation and sore healing when used externally. Therefore, its viscosity is taken, while nourishing and moderating the medicinal properties, it is used as an excellent excipient.

[0037] The ancient Chinese medicine circular movement theory is an important theoretical system in traditional Chinese medicine. Its basic idea originated from classic works such as "Huangdi Neijing" and "Treatise on Febrile and Miscellaneous Diseases", emphasizing that the life activities of the human body are a process of repeated cycles and dynamic balance. The human body is an organic whole, and the zang-fu organs, meridians, qi and blood are interconnected and interact with each other. The life activities of qi and blood, yin and yang, five elements, etc. in the human body are a continuous cycle process, and human health depends on the dynamic balance of qi and blood, yin and yang, and five elements.

[0038] The spleen and stomach are located in the middle-jiao, being the source of qi and blood generation and also the hub of the circular movement. The spleen is responsible for ascending the clear, and the stomach is responsible for descending the turbid. The two coordinate and operate to maintain the ascending and descending balance of qi and blood. Therefore, the spleen and stomach are the hub of qi movement.

[0039] Cloves: warm in nature, pungent in taste, returning to the spleen, stomach, lung and kidney meridians. Its pungent and warm nature can help the yang qi of the spleen and stomach to rise, warm the middle-jiao, disperse cold pathogens, restore the driving force of the spleen and stomach in transportation and transformation, and make the yang qi in the middle-jiao be invigorated to promote the qi to rise.

[0040] Fennel: also warm in nature and pungent in taste, entering the liver, kidney, spleen and stomach meridians. It can warm the liver and kidney and warm the spleen and stomach, helping to promote the ascending movement of yang qi in the lower-jiao. Collaborating with cloves, it strengthens the stimulation of yang qi in the middle-jiao and lower-jiao, making the yang qi rise more powerfully along the left path. Moreover, its pungent and fragrant taste can regulate qi and relieve stagnation, assisting in dredging qi flow.

[0041] Costus root: Pungent, pungent, and warm, it circulates Qi throughout the three burners, particularly relieving Qi stagnation in the spleen and stomach. It can unblock stagnant Qi in the middle burner, allowing the spleen and stomach Qi to ascend and descend smoothly. It acts as a barrier at a key hub in the middle burner Qi, ensuring the smooth flow of Qi, allowing for smoother communication between the upper and lower burners, and promoting the normal operation of circular motion.

[0042] Wuyao: Pungent and warm, it enters the lung, spleen, kidney and bladder meridians. It is good at promoting qi, dispersing cold and relieving pain. It can warm the kidney and dissipate cold to help the growth of yang qi. It can also dredge qi in the middle and lower burners, enhance the rising power of yang qi in the lower burner and the mediation power of qi in the middle burner. It plays an important role in pushing the overall qi from bottom to top, and helps to restore the power of left rise in circular motion.

[0043] Magnolia officinalis: Bitter, pungent, and warm, it dries dampness and eliminates phlegm, and relieves qi and fullness. Its primary effect is on the spleen and stomach in the middle burner. By lowering qi, it regulates the ascending and descending balance of qi in the middle burner. This not only assists in clearing dampness and qi stagnation in the middle burner during the rise of yang qi, but also prevents excessive upward movement of qi, ensuring orderly ascending and descending of qi in the middle burner and the stable operation of circular motion in the middle burner.

[0044] Cyperus rotundus: It is the general director of Qi disorders and the chief commander of gynecology. It is neutral in nature, with a slightly bitter and sweet flavor. It enters the Liver, Spleen, and Triple Burner meridians. It can soothe the liver and regulate Qi, regulate menstruation, and relieve pain. By relieving liver depression and promoting the flow of liver Qi, it can help the liver wood flow freely without stagnation, promoting the smooth ascending of Qi on the left side. Because the liver governs the flow of Qi, its smooth flow plays a crucial role in guiding the rise and fall of Qi throughout the body, thereby promoting the orderly progress of the overall circular motion.

[0045] Borneol is slightly cold in nature, bitter in flavor, and enters the Heart, Spleen, and Lung meridians. Despite its slightly cold nature, a small amount can awaken the mind, clear away heat, and relieve pain. It can also guide the upward movement of other herbs. Among a large group of warming herbs, it can prevent excessive warming and dryness, ensuring that the Qi movement of the entire prescription does not lean too far toward warming and rising, but rather maintains a relatively balanced, orderly circular motion. Furthermore, its wandering nature can promote the effectiveness of the herbs, unblocking Qi and blood throughout the body's meridians and ensuring orderly Qi flow at all levels.

[0046] Honey is sweet and mild, and has the effects of nourishing the middle and moistening dryness, relieving pain and detoxifying. In prescriptions, it can not only moderate the properties of various drugs, preventing them from being too warm or harsh and damaging to the vital energy, but also nourish the spleen and stomach, protect the middle burner, and provide a certain material basis for the biochemical transformation of spleen and stomach qi, ensuring the stable and long-lasting function of the spleen and stomach as the hub of qi movement, so that the entire circular motion has sufficient power source and material guarantee.

[0047] The comprehensive prescription and the combination of various medicines can regulate the rise and fall of human qi through multiple effects such as warming yang, regulating qi, drying dampness, and soothing the liver, so that the spleen and stomach hub in the middle burner can operate flexibly, the yang qi in the lower burner can be promoted, and the qi in the upper burner can be descended, restoring the normal rhythm of the circular motion of human qi, thereby regulating qi and blood, balancing yin and yang, and treating various diseases caused by qi imbalance.

[0048] The overall formula warms the middle-jiao and strengthens the healthy qi, regulates qi and promotes qi movement, embodying the balance principle of traditional Chinese medicine treatment method of "warming without dryness, dredging without excessive harshness". It is suitable for non-oral intervention means for postoperative intestinal function recovery, improving patient comfort and compliance. It conforms to the treatment method of "regulating the middle-jiao and strengthening the healthy qi, warming yang and promoting qi movement, dredging the fu-organs and promoting qi movement", and has both practicality and theoretical support.

[0049] The beneficial effects of the present invention are as follows: Combining traditional Chinese medicine syndrome differentiation theory with modern ERAS rehabilitation pathway, the present invention proposes a traditional Chinese medicine patch for promoting qi movement and dredging stagnation, warming yang and dispelling cold. It is applied externally at the Shenque acupoint for postoperative patients, and has clinical advantages such as convenient operation, high safety, and good compliance. It innovatively solves the problem of slow postoperative intestinal function recovery. The medicine of the present invention can help dredge qi mechanism, promote intestinal peristalsis, relieve discomfort symptoms such as postoperative abdominal distension and constipation, and conforms to the treatment principle of traditional Chinese medicine of "regulating the spleen and stomach, dredging qi mechanism, and promoting intestinal recovery". It is especially suitable for postoperative patients with syndromes of yang deficiency of the spleen and stomach, yang deficiency and cold of Yangming, and qi stagnation and blood stasis. Brief Description of the Drawings

[0050] Figure 1 Postoperative exhaust time of abdominal surgery patients (*: There is a statistically significant difference between the two groups, P < 0.05). Detailed Description of the Invention

[0051] Example 1 Preparation of the traditional Chinese medicine composition patch of the present invention Weigh the traditional Chinese medicine raw materials: 211 g of clove, 211 g of fennel, 105 g of Aucklandia lappa, 63 g of Lindera aggregata, 63 g of Cyperus rotundus, 63 g of Magnolia officinalis, and 11 g of borneol. After pulverizing and sieving, mix them. Each unit dose of the patch contains 5.5 g of traditional Chinese medicine powder, supplemented with 3.5 g of honey and an appropriate amount of matrix to make the patch.

[0052] The preparation method includes: removing impurities and coarsely crushing each traditional Chinese medicine raw material; pulverizing, passing through an 80-mesh sieve to obtain uniform fine powder; uniformly mixing each raw material powder according to the ratio; coating the ointment on a non-woven fabric substrate and cutting it into a patch with a specification of 6 cm × 4 cm.

[0053] Example 2 Preparation of the traditional Chinese medicine composition patch of the present invention Weigh the traditional Chinese medicine raw materials: 168 g of clove, 168 g of fennel, 84 g of Aucklandia lappa, 50 g of Lindera aggregata, 50 g of Cyperus rotundus, 50 g of Magnolia officinalis, and 8 g of borneol. Prepare the patch according to the method of Example 1.

[0054] Example 3 Preparation of the traditional Chinese medicine composition patch of the present invention Weigh the traditional Chinese medicine raw materials: 254 g of clove, 254 g of fennel, 126 g of Aucklandia lappa, 76 g of Lindera aggregata, 76 g of Cyperus rotundus, 76 g of Magnolia officinalis, and 14 g of borneol. Prepare the patch according to the method of Example 1.

[0055] The beneficial effects of the present invention are demonstrated by the following clinical trials.

[0056] Test Example 1 Clinical Trial of the Traditional Chinese Medicine Composition of the Present Invention A prospective, randomized, controlled, single-blind clinical study was conducted in West China Hospital of Sichuan University from December 2024 to March 2025 on 52 abdominal surgery patients who met the inclusion criteria.

[0057] 1. Research Subjects 1.1 Inclusion Criteria 1) Aged 18–70 years old; 2) Undergoing the first abdominal surgery; 3) Signing the informed consent within 1 day before surgery; 4) Having no history of severe gastrointestinal diseases before surgery; 5) Having no local skin damage, infection, etc. at the Shenque acupoint.

[0058] 1.2 Exclusion Criteria 1) Pregnant or lactating women; 2) Those who require endotracheal intubation and transfer to the ICU for treatment; 3) Those with severe allergic constitution or known allergy to traditional Chinese medicine ingredients; 4) Those with severe liver and kidney function disorders; 5) Those with severe complications such as malignant tumors and peritonitis.

[0059] 2. Case Sample Size • Experimental group: 13 cases • Control group 1 (placebo control): 13 cases • Control group 2 (traditional formula control): 11 cases • Blank control group (only conventional treatment): 15 cases • Total sample size: 52 cases 3. Grouping and Intervention 3.1 Grouping Method The computer random number method was used for random grouping, and the personnel responsible for trial allocation were separated from the personnel implementing the treatment to ensure a single-blind design.

[0060] 3.2 Intervention Plan Group and Intervention Measures Experimental group: The Qi-regulating and stagnation-dispersing patch prepared in Example 1 was applied to the Shenque acupoint. The unit dose of each patch was 20 g of ointment (containing 5.5 g of traditional Chinese medicine powder, 3.5 g of honey, and the rest were excipients and carriers). It was used 1 patch per day, applied to the Shenque acupoint for 6–8 hours each time, and continuously applied for 3 days or until exhaust and defecation.

[0061] Control group 1: Glutinous rice flour + fennel were used to simulate the patch, with the same appearance and dose.

[0062] Control group 2: Magnolia officinalis + stir-fried Atractylodes lancea + clove + fennel patch with the same dosage.

[0063] Blank control group: routine ERAS postoperative management, without dressing intervention.

[0064] 3.3 Patch formulation and preparation Group Formula Blank control group None Control group 1 Fennel 211 g, glutinous rice flour 789 g, mixed into a paste and divided into portions Control group 2 Magnolia officinalis 50 g, stir-fried Fructus Aurantii 50 g, clove 30 g, fennel 250 g, mixed and ground into a powder Experimental group Clove 211 g, fennel 211 g, Aucklandia lappa 105 g, Lindera aggregata 63 g, Magnolia officinalis 63 g, Cyperus rotundus 63 g, borneol 11 g, honey 168 g 4. Statistical analysis SPSS 26.0 software was used for data processing. Continuous variables were expressed as x ± s, and one-way analysis of variance (ANOVA) was used for comparisons among groups. Enumeration data were expressed as number of cases and percentages, and the χ² test was used; The significance level was set at P<0.05.

[0065] 5. The results are shown in Table 1 and Table 2. Figure 1 .

[0066] Table 1 Postoperative flatus time of all included patients (min) Number of cases Blank control group Control group 1 Control group 2 Experimental group 1 4933 4699 3840 4200 2 4260 3877 5834 4500 3 5598 4432 4350 5134 4 3182 7148 6270 1635 5 8994 7630 3840 3082 6 5633 4010 4030 2818 7 6590 5035 7350 3093 8 4500 3219 5280 3720 9 4080 3720 7860 5553 10 6879 8280 3750 5596 11 4276 4410 3660 4488 12 4532 8700 3175 13 7048 5475 3900 14 3118 15 5328 Average postoperative exhaust time (min) 5263±1587 5433±1861 5097±1530 3915±1158 Table 2 Basic information of patients undergoing abdominal surgery and duration of postoperative flatulence Blank control (N = 15) Control group 1 (N = 13) Control group 2 (N = 11) Experimental group (N = 13) Gender (male) 11（73.3%） 6（46.1%） 6（54.5%） 9（69.2%） Age (years) 56.8±15.1 54.2±13.9 45.2±18.0 54.0±13.6 Exhaust duration (minutes) 5263±1587 5433±1861 5097±1530 3915±1158 Adverse event rate 0.0% 0.0% 12.5% 0.0% Note: N: number of cases. Adverse events: In control group 2, one patient developed contact dermatitis after application.

[0067] The results showed that the time to first anal flatus after surgery was observed in the experimental group, which was the shortest among the four groups, with a statistically significant difference compared with the blank control group, control group 1, and control group 2 (P < 0.05). There was no statistically significant difference between the blank control group, control group 1, and control group 2 (P > 0.05).

[0068] The blank control group: Patients did not receive any patch intervention and relied solely on natural recovery and routine postoperative care (early feeding, pain relief, early mobilization, etc.). Transient intestinal paralysis is common after surgery due to factors such as intraoperative anesthesia, pneumoperitoneum, and intestinal traction. Intestinal recovery depends on endogenous qi and blood circulation. Therefore, conventional ERAS currently cannot completely resolve the problem of slow intestinal function.

[0069] Control group 1: Fennel (Fennel) has the effects of warming yang, dispersing cold, promoting qi and relieving pain, but its single herbal effect is weak; Control group 2: Traditional drugs for promoting qi flow and eliminating indigestion, and breaking stagnation to promote bowel movement. Magnolia officinalis can dry dampness and relieve fullness, promote qi flow and relieve constipation quickly; stir-fried Fructus Aurantii can break qi and promote qi stagnation, and relieve fullness in the chest and abdomen; Flos Caryophylli and Fructus Foeniculi can warm the middle-jiao to stop vomiting and regulate cold stagnation. The experimental results show that the curative effect of this control group is inferior to that of the experimental group, suggesting that qi-promoting drugs are the core, but drugs for warming yang, regulating blood circulation, and dredging collaterals are still needed for synergistic effect.

[0070] Experimental group: The raw material formula of the drug of the present invention synergistically combines five effects of promoting qi flow + warming yang + promoting blood circulation + promoting penetration + regulating the middle-jiao. Among them, Aucklandia lappa, Magnolia officinalis, Fructus Foeniculi, and Flos Caryophylli can promote qi stagnation; Lindera aggregata and Flos Caryophylli can warm yang and relieve pain; Cyperus rotundus regulates qi and relieves depression; Borneol induces resuscitation and promotes absorption. The experimental group has the shortest exhaust time and the best effect, proving that the drug of the present invention conforms to the triple mechanism synergism of traditional Chinese medicine of "syndrome differentiation and formula composition + acupoint stimulation + transdermal drug delivery". The drug of the present invention uses the Shenque acupoint as a specific external treatment acupoint, combined with the drug to form a "treating internal diseases from external" closed-loop path; the synergistic effect of multiple raw materials is far better than that of single herbs or simple prescriptions, which conforms to the pathogenesis of postoperative deficiency and stagnation of "multi-channel conditioning".

[0071] "Synopsis of the Golden Chamber" points out that "after a serious illness, the deficiency and damage are the most serious". Postoperative recovery needs to take into account "regulating the middle-jiao and strengthening healthy qi" and "promoting qi downward and eliminating stagnation". After abdominal surgery, it is often "weakness of yang-qi in the yangming fu-organ and qi stagnation with damp obstruction". In the early postoperative stage, qi stagnation is the main factor, and the treatment should be "promoting qi flow first and assisting with warming yang". The Shenque acupoint is selected, which mainly dredges the triple energizer, supports the spleen yang, and regulates qi and blood, and is an "important acupoint" for external treatment. Acupoint application can stimulate the skin nerve endings and activate the enteric-brain-axis nerve reflex; ingredients such as Flos Caryophylli, Fructus Foeniculi, and Magnolia officinalis have the effects of promoting intestinal peristalsis, anti-inflammation, and relieving pain; Borneol can increase the capillary permeability and enhance the skin absorption rate of active ingredients; honey is a natural skin-friendly matrix, which helps to stabilize the release rate of the patch. Clinical results show that the traditional Chinese medicine patch of the present invention can significantly shorten the postoperative exhaust time (P < 0.05), which is better than the blank control group and the conventional control group, indicating that it has a good effect in promoting gastrointestinal peristalsis and relieving abdominal distension in the early postoperative stage, has no obvious adverse reactions, and has good safety. Its curative mechanism is related to the synergism of acupoint stimulation + transdermal absorption + multi-target pharmacological effects.

Claims

1. A traditional Chinese medicine composition for promoting the recovery of intestinal function in patients after abdominal surgery, characterized in that: It is prepared from the following raw medicinal materials in parts by weight: 168 - 254 parts of Flos Caryophylli, 168 - 254 parts of Fructus Foeniculi, 84 - 126 parts of Radix Aucklandiae, 50 - 76 parts of Radix Linderae, 50 - 76 parts of Rhizoma Cyperi, 50 - 76 parts of Cortex Magnoliae Officinalis, 8 - 14 parts of Borneolum Syntheticum.

2. The traditional Chinese medicine composition for promoting the recovery of intestinal function in patients after abdominal surgery according to claim 1, wherein: It is prepared from the following raw medicinal materials in the following weight ratio: 211 parts of Flos Caryophylli, 211 parts of Fructus Foeniculi, 105 parts of Radix Aucklandiae, 63 parts of Radix Linderae, 63 parts of Rhizoma Cyperi, 63 parts of Cortex Magnoliae Officinalis, 11 parts of Borneolum Syntheticum.

3. The traditional Chinese medicine composition for promoting the postoperative intestinal function recovery of abdominal surgery patients according to claim 1 or 2, characterized in that: It takes the crude drug powder of the raw medicinal materials, the extract of water or organic solvent as the active ingredient, and adds pharmaceutically acceptable excipients or auxiliary components to prepare a pharmaceutically common external preparation.

4. The traditional Chinese medicine composition for promoting the recovery of intestinal function after abdominal surgery according to claim 3, wherein: The excipient is honey.

5. The traditional Chinese medicine composition for promoting the recovery of intestinal function in patients after abdominal surgery according to claim 3, wherein: The external preparation is ointment, cream, gel, patch, powder, paste, film, lotion, tincture, liniment, aerosol, spray, suppository.

6. A preparation method of a traditional Chinese medicine composition for promoting the recovery of intestinal function after abdominal surgery according to any one of claims 1-5, characterized in that: It includes the following steps: a. Weigh the raw medicinal materials in the following weight ratio; b. Powder or extract with water or organic solvent, and then add pharmaceutically acceptable excipients or auxiliary components to prepare a pharmaceutically common external preparation.

7. Use of the traditional Chinese medicine composition according to any one of claims 1 - 5 in the preparation of an external drug for promoting the recovery of intestinal function in patients after abdominal surgery.

8. The use according to claim 7, wherein: The drug is used for treating gastrointestinal dysfunction caused by Yang - Ming deficiency - cold syndrome and spleen - stomach Yang deficiency.

9. The use according to claim 7, wherein: The drug is used for relieving symptoms of postoperative ileus, abdominal distension, constipation, and weak defecation.

10. Use according to any one of claims 7 - 9, characterized in that: The drug is administered to the Shenque acupoint.

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