A traditional Chinese medicine composition for promoting intestinal function recovery in patients undergoing abdominal surgery, and its preparation method and use

Abstract

The present invention relates to a Chinese medicine composition for promoting postoperative intestinal function recovery in patients undergoing abdominal surgery, and its preparation method and use, and belongs to the field of Chinese medicine. The Chinese medicine composition of the present invention 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 root, 50-76 parts of cyperus rotundus, 50-76 parts of magnolia bark, and 8-14 parts of borneol. The present invention also provides a preparation method and use of the Chinese medicine composition. The present invention adopts an external application mode of applying Shenque acupoint, which improves clinical compliance and safety. Clinical data show that it can significantly shorten flatus time, improve postoperative intestinal dysfunction, and has good promotion and application prospects.

Description

Technical Field

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

[0002] After abdominal surgery, patients often experience postoperative intestinal paralysis (POI), which is a temporary suppression of gastrointestinal function caused by various factors such as surgical trauma, anesthetics, and opioid analgesics. Currently, the drugs that promote the recovery of intestinal function in patients undergoing abdominal surgery are mainly oral, such as:

[0003] 1. Prokinetic drugs

[0004] Prucalopride: Prucalopride is a highly selective 5-HT4 receptor agonist that enhances gastrointestinal motility. Studies have shown that prucalopride can significantly shorten the time to first bowel movement and first flatus after surgery, reducing the incidence of postoperative POI. However, another multicenter, double-blind, placebo-controlled study found that while prucalopride shortened the time to first bowel movement, it had no significant effect on the incidence of POI or length of hospital stay.

[0005] Mosapride: Mosapride is also a 5-HT4 receptor agonist primarily used to treat gastrointestinal motility disorders. Although large-scale clinical trials directly evaluating its effect on postoperative intestinal function recovery after abdominal surgery are lacking, its potential role in improving gastrointestinal motility makes it a potentially beneficial supplement for postoperative recovery.

[0006] 2. Opioid receptor antagonists

[0007] Alvimopan: Alvimopan is a peripheral μ-opioid receptor antagonist that blocks the inhibitory effects of opioids on the gastrointestinal tract without affecting central analgesia. Multiple studies have shown that alvimopan can significantly shorten the time to first flatus and bowel movement and hospital stay after surgery, and reduce the incidence of POI-related complications. However, alvimopan has not yet been approved for clinical use in China or Europe.

[0008] Naloxone: Naloxone is a non-selective opioid receptor antagonist that can be administered intravenously or orally. Although its application in postoperative gastrointestinal function recovery is less common, some studies have shown that naloxone can shorten the time to gastrointestinal function recovery after surgery.

[0009] 3. Other drugs

[0010] Cimetidine: Cimetidine is an H2 receptor antagonist that can inhibit gastric acid secretion and reduce gastrointestinal irritation, which may have a positive effect on the recovery of gastrointestinal function after surgery.

[0011] Coffee: The caffeine in coffee can dilate vascular smooth muscle and reduce inflammatory response. Many studies have found that coffee can reduce the incidence of POI.

[0012] Simethicone: Simethicone can merge bubbles in the intestine and promote gas excretion, but a multicenter, double-blind, placebo-controlled study did not find that it had a significant effect on the time to first flatus, defecation, and length of hospital stay after surgery.

[0013] Gastrografin: Gastrografin is a water-soluble contrast agent that increases intestinal fluid volume, reduces intestinal wall edema, and improves intestinal motility. However, multiple studies and meta-analyses have shown that gastrografin is not effective in preventing or treating POI.

[0014] 4. Traditional Chinese Medicine

[0015] Wuda Granule: Wuda Granule is a traditional Chinese medicine compound consisting of ginseng, betel nut, peach kernel, lindera striata, and amomum villosum. Studies have shown that Wuda Granule can significantly improve decreased gastrointestinal motility after abdominal surgery and promote postoperative gastrointestinal function recovery.

[0016] 5. Analgesics

[0017] Nonsteroidal anti-inflammatory drugs (NSAIDs): NSAIDs can inhibit the cyclooxygenase pathway, reduce the synthesis of inflammatory mediators, and alleviate postoperative inflammatory responses, thereby facilitating the recovery of postoperative gastrointestinal function. A meta-analysis showed that NSAIDs can shorten the time it takes to pass flatus and defecate after surgery.

[0018] Dexamethasone: Dexamethasone is a glucocorticoid that can reduce the concentration of postoperative inflammatory factors, improve the degree of postoperative abdominal distension, promote liquid diet tolerance, and thus promote gastrointestinal function recovery.

[0019] Lidocaine: Lidocaine can reduce the production of complement and proinflammatory factors, inhibit gastrointestinal inflammatory response, reduce the occurrence of postoperative intestinal obstruction, and directly inhibit the mesenteric sympathetic plexus, reducing the dosage of postoperative opioids, thereby promoting postoperative gastrointestinal function recovery.

[0020] 5. Other treatment measures

[0021] Multimodal analgesia: Multimodal analgesia regimen can reduce the dosage of opioids and reduce their inhibitory effects on the gastrointestinal tract by combining multiple analgesic drugs and techniques, thereby promoting postoperative gastrointestinal function recovery.

[0022] Early enteral nutrition: Early enteral nutrition can regulate the immune response, reduce postoperative inflammatory response, and shorten the duration of POI.

[0023] With the increasing popularity of the modern concept of Enhanced Recovery After Surgery (ERAS), postoperative intestinal function restoration has become a key component in improving patient recovery quality and shortening hospital stays. However, current clinical medications for intestinal function restoration are mostly oral or invasive, which are prone to adverse reactions and are not suitable for patients who are unable to take food orally in the early postoperative period.

[0024] There are also relevant reports on external use of traditional Chinese medicine, such as Ruan Mei, Effect of Chinese medicine acupoint application on intestinal function recovery after gastrointestinal surgery, Nursing and Rehabilitation, Volume 13, Issue 1, January 2014, which observed the effect of Chinese medicine acupoint application on promoting intestinal function recovery after gastrointestinal surgery. The Chinese medicine prescription disclosed in this document is: 9g of Linderae scabra, 8g of cumin, 10g of Citrus aurantium, 10g of Xuanming powder, 3g of borneol, 9g of Areca catechu, and 9g of raw rhubarb.

[0025] CN202310398562.5, Invention Name: A Chinese medicine compound preparation for treating gastrointestinal dysfunction, its preparation method and application, discloses a Chinese medicine compound preparation for treating gastrointestinal dysfunction, which is made from the following medicinal materials: Magnolia officinalis, fried Citrus aurantium, cloves and cumin. Also disclosed are the preparation method and application of the Chinese medicine compound preparation. The Chinese medicine compound preparation can be used to prepare medicines for treating patients' gastrointestinal dysfunction and promoting intestinal function recovery, and can also be used to prepare medicines for treating complications of liver cirrhosis. The present invention mainly uses external treatment of traditional Chinese medicine to promote drug absorption by applying Chinese medicine preparations on acupuncture points or local skin.

[0026] CN201110003245.6, Invention Title: A Method for Preparing a Stomachache Paste, discloses a method for preparing a stomachache paste. Cloves, costus root, frankincense, agarwood, and cyperus rotundus are dried and ground into a very fine powder. Borneol is then ground into a fine powder and evenly mixed with the powdered herbs. Ginger and green onions are then chopped and mashed into a paste. The juice is then mixed with the powdered herbs to form a paste. The paste is applied to the Shenque acupoint when a stomachache is present and secured with adhesive tape.

[0027] CN202411086719.1, invention name: Disclosed is a traditional Chinese medicine composition for treating gastrointestinal dysfunction after abdominal surgery, as well as its preparation method and application, belonging to the technical field of traditional Chinese medicine preparation; the traditional Chinese medicine composition includes fennel, wormwood, magnolia bark, cinnamon, dried ginger, costus root, pepper, clove, spikenard, angelica dahurica and isocyanate; during preparation, fennel, wormwood, magnolia bark, cinnamon, dried ginger, costus root, pepper, clove, spikenard and angelica dahurica are first crushed, and then the crushed drugs are mixed with isocyanate; after the prepared traditional Chinese medicine composition is applied to gastrointestinal dysfunction after abdominal surgery, it is found that it has better therapeutic effect in treating gastrointestinal function, such as early flatus and defecation, abdominal distension and other accompanying symptoms of patients, especially for symptoms such as abdominal pain, nausea, vomiting, etc., and has certain advantages. The formula in this application has a warming nature and is suitable for postoperative symptoms such as yang deficiency and cold stagnation, qi stagnation and abdominal distension, loss of appetite, and abdominal fullness. Mugwort, Sichuan peppercorns, and Daqing salt have meridian-warming and cold-dispelling and anti-infective properties, making them effective for topical application. Angelica dahurica has a fragrant aroma that enhances penetration and can also relieve postoperative headaches and abdominal distension. However, its drawbacks are that it contains a large number of warming and hot-heating drugs, making it unsuitable for patients with damp-heat, yin deficiency, or postoperative fever and infection. The lack of heat-clearing, detoxifying, or moisturizing agents makes it unsuitable for those with constipation, dry mouth, or a red tongue with a yellow coating.

[0028] 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 plaster comprises the following components: fennel, comprising 70-80% by weight; cloves, comprising 5-9% by weight; immature bitter orange, comprising 5-9% by weight; rhubarb, comprising 5-9% by weight; and borneol, comprising 2-4% by weight. The plaster is easy to use, has rapid effects, and offers excellent therapeutic efficacy. It can effectively alleviate and treat various postoperative conditions, including abdominal distension, stagnation in the middle burner, and visceral qi obstruction. This patent document is suitable for patients with postoperative visceral qi obstruction, abdominal distension, and constipation, demonstrating significant "clearing, descending, and removing stagnation" effects. Modern ingredients (silver ions and vitamin E) enhance antibacterial, anti-inflammatory, and tissue repair capabilities. The sustained-release material improves bioavailability, facilitating clinical application. However, the formula disclosed in this document has a strong, aggressive, and strengthening nature, making it unsuitable for those with weak constitutions or those experiencing severe spleen deficiency in the early postoperative period. Because it contains rhubarb, caution should be exercised regarding skin irritation and potential side effects from prolonged use when used topically. It is not suitable for those experiencing severe postoperative weakness, those prone to diarrhea, or those with recently completed intestinal anastomoses that have not yet healed. Furthermore, for rhubarb-containing formulas, the dosage and application concentration must be strictly controlled to prevent excessive diarrhea and local irritation.

[0029] Traditional Chinese Medicine (TCM) syndrome differentiation for postoperative intestinal dysfunction in patients undergoing abdominal surgery is primarily based on TCM's holistic approach and principles of syndrome differentiation and treatment. This approach integrates the patient's specific symptoms, signs, and postoperative pathophysiological characteristics for comprehensive analysis and assessment. Numerous syndrome types are classified, including: Qi stagnation and blood stasis, liver-stomach disharmony, Qi and blood deficiency, internal accumulation of dampness and heat, and spleen and stomach deficiency and cold. Due to the complexity of TCM syndrome differentiation for postoperative intestinal dysfunction in patients undergoing abdominal surgery, there are currently no targeted medications for treating gastrointestinal dysfunction caused by Yangming deficiency and cold syndrome and spleen and stomach yang deficiency. Summary of the Invention

[0030] The purpose of the present invention is to provide a traditional Chinese medicine external application composition that can significantly promote the recovery of intestinal function in patients undergoing abdominal surgery, and to propose its preparation method and medical use, so as to make up for the shortcomings of current postoperative rehabilitation methods.

[0031] The present invention provides a traditional Chinese medicine composition for promoting the recovery of intestinal function in patients undergoing abdominal surgery, characterized in that the composition is prepared from the following raw materials in parts by weight:

[0032] 168-254 parts of cloves, 168-254 parts of fennel seeds, 84-126 parts of costus roots, 50-76 parts of lindera stalks, 50-76 parts of cyperus rotundus, 50-76 parts of magnolia bark, and 8-14 parts of borneol.

[0033] Preferably, it is prepared from the following raw materials in the following weight ratio:

[0034] 211 parts of cloves, 211 parts of fennel seeds, 105 parts of costus roots, 63 parts of lindera stalks, 63 parts of cyperus rotundus, 63 parts of magnolia bark, and 11 parts of borneol.

[0035] The Chinese medicine composition of the present invention is prepared from the raw powder of the raw medicine, water or organic solvent extract as active ingredients, and pharmaceutically acceptable excipients or auxiliary ingredients to form a commonly used external preparation in medicine.

[0036] Wherein, the auxiliary material is honey.

[0037] The external preparations are ointments, creams, gels, patches, powders, pastes, films, lotions, tinctures, liniments, aerosols, sprays, suppositories, etc.

[0038] The present invention also provides a method for preparing the traditional Chinese medicine composition for promoting postoperative intestinal function recovery in patients undergoing abdominal surgery, which comprises the following steps:

[0039] a. Weigh the APIs of various weight ratios;

[0040] b. Powdering or adding water or organic solvent for extraction, and then adding pharmaceutically acceptable excipients or auxiliary ingredients to prepare a commonly used external preparation in medicine.

[0041] The present invention also provides use of the traditional Chinese medicine composition in preparing an external-use medicine for promoting postoperative intestinal function recovery in patients undergoing abdominal surgery.

[0042] The medicine is used to treat Yangming deficiency-cold syndrome and gastrointestinal dysfunction caused by spleen and stomach yang deficiency.

[0043] The medicine is used to relieve postoperative intestinal paralysis, abdominal distension, constipation, and weak defecation symptoms.

[0044] Wherein, the medicine is applied to the Shenque point.

[0045] Compared to formulas like CN202310398562.5, this drug utilizes a triple strategy of "Shenque acupoint application + warming yang and promoting qi circulation + enhanced permeation," resulting in stronger targeting and synergistic effects. Compared to the more aggressive herbs used in CN202411291281.0, such as rhubarb and immature bitter orange, this drug has milder properties, is suitable for patients with postoperative deficiency syndromes, and offers greater safety.

[0046] The Golden Chamber states, "After any serious illness, exhaustion is the most severe." Postoperative recovery requires a balanced approach of "regulating the middle and strengthening the body" and "clearing and dispersing stagnation." According to Traditional Chinese Medicine (TCM) syndrome differentiation, abdominal surgery often presents with "Yangming visceral Qi deficiency and Qi stagnation and dampness obstruction." Qi stagnation is the primary symptom in the early postoperative period, and treatment should prioritize "promoting Qi flow and supporting Yang." In the early postoperative period (0-3 days), patients present with abdominal distension, poor flatus, abdominal distension, nausea, a pale tongue with a white coating, and a slow pulse. The primary pathogenesis is Qi stagnation and cold stagnation, visceral Qi obstruction, and spleen Yang damage. The primary syndrome is Qi stagnation, with some cold stagnation present. In the mid-postoperative period (3-7 days), patients present with significant abdominal distension, poor flatus, constipation, and a yellow, greasy tongue. The primary pathogenesis is gradual resolution of Qi stagnation, internal visceral fullness, or damp-heat stasis. The syndrome differentiation is mainly qi stagnation and bowel fullness, with damp-heat and blood stasis. During the postoperative recovery period (after 7 days), the patient's main symptoms are poor appetite, fatigue, loose stools, pale tongue with a thin coating, and spleen and stomach deficiency and qi failure as the main pathogenesis. The syndrome differentiation is mainly spleen deficiency with mild dampness.

[0047] This traditional Chinese medicine composition is based on classic Chinese medicine texts such as the Yellow Emperor's Classic of Internal Medicine and Treatise on Febrile and Miscellaneous Diseases. Postoperative symptoms often include spleen and stomach deficiency, cold, qi stagnation, and blood stasis. This sluggish qi movement allows the invasion of internal pathogenic cold, leading to dysfunction of the spleen's ascending and stomach's descending functions, manifesting as abdominal distension, constipation, difficulty passing gas, nausea, and vomiting. Traditional Chinese medicine prioritizes regulating qi, and external treatments specifically target the Shenque point (center of the navel), known as the "root of vital qi." This point has the unique advantage of regulating the internal organs and promoting blood circulation. This traditional Chinese medicine composition, centered on "warming yang and promoting qi circulation," is particularly suitable for early postoperative symptoms of cold stagnation and qi stagnation. Its rational combination of ingredients is warming but not drying, and it also has some blood-activating properties. Honey can be used in transdermal patches or topical formulations, synergizing with borneol to enhance penetration.

[0048] The ingredients in this traditional Chinese medicine composition are warm in nature and pungent in flavor. Their combination effectively dispels cold pathogens in the spleen, stomach, and liver meridians. Cloves warm the middle and reduce adverse reactions, and their warming properties dispel cold stagnation in the middle burner, alleviating symptoms such as epigastric cold pain and vomiting. Fennel warms the liver and dispels cold, relieving symptoms such as lower abdominal cold pain and hernia caused by cold stagnation in the liver meridian. This dissolves the cold stagnation and restores the warmth and circulation of Yang Qi. The two herbs complement each other, working together to warm the interior, dispel cold, promote qi circulation, and relieve pain, making them the sovereign herbs. Costus root promotes qi circulation, relieves pain, strengthens the spleen, and aids digestion, specifically unblocking qi stagnation in the spleen and stomach, improving symptoms such as epigastric distension and loss of appetite. Magnolia bark dries dampness, eliminates phlegm, and relieves qi distension, effectively addressing abdominal distension, bloating, and constipation caused by dampness and qi stagnation in the middle jiao. Cyperus rotundus soothes the liver, regulates qi, and regulates menstruation to relieve pain, specifically addressing symptoms such as flank pain and depression caused by liver qi stagnation. By regulating liver qi and coordinating the flow of qi throughout the body, it breaks the pathological state of qi stagnation, allowing qi to rise and fall in an orderly manner and restoring normal spleen and stomach transport and transformation functions. These three herbs work together to regulate qi and clear the triple jiao, dissipating stagnation, and are considered assistant herbs. Borneol: pungent, bitter, and slightly cold, it enters the heart, spleen, and lung meridians. Honey: sweet and neutral, it enters the lung, spleen, and large intestine meridians. This medicine is sweet and mild in nature, enters the spleen meridian, nourishes the spleen, can both tonify the middle and relieve acute pain, and has the effect of promoting tissue regeneration and healing sores when applied externally. Therefore, its viscosity is taken advantage of, and it is used as a high-quality excipient while nourishing and alleviating the medicinal properties.

[0049] The ancient Chinese medicine theory of circular motion is a key theoretical framework within Traditional Chinese Medicine. Its fundamental principles, derived from classic works such as the Yellow Emperor's Classic of Internal Medicine and the Treatise on Febrile and Miscellaneous Diseases, emphasize that the human body's vital activities are a cyclical, dynamic equilibrium process. The human body is an organic whole, with the internal organs, meridians, and qi and blood interconnected and influencing each other. The vital activities of the human body, including qi and blood, yin and yang, and the five elements, are an endless cycle, and human health depends on the dynamic balance of qi and blood, yin and yang, and the five elements.

[0050] The spleen and stomach, located in the middle burner, are the source of Qi and blood production and the hub of circular motion. The spleen is responsible for ascending the lucid, while the stomach descends the turbid. Their coordinated function maintains the ascending and descending balance of Qi and blood. Therefore, the spleen and stomach are the hubs of Qi's ascending and descending motion.

[0051] Clove: Warm in nature, pungent in taste, it enters the spleen, stomach, lung, and kidney meridians. Its pungent and warm nature can help the spleen and stomach to raise their yang energy, warm the middle burner, dispel pathogenic cold, and restore the spleen and stomach's power of transportation and transformation, invigorating the yang energy in the middle burner and promoting the upward movement of qi.

[0052] Fennel: It is also warm in nature and spicy in taste. It enters the liver, kidney, spleen and stomach meridians. It can warm the liver and kidney and warm the spleen and stomach, which helps to promote the rise of Yang Qi in the lower burner. It works together with cloves to strengthen the stimulation of Yang Qi in the middle and lower burners, making the Yang Qi rise more powerfully along the left path. Its spicy taste can regulate Qi and remove stagnation, helping to unblock the Qi mechanism.

[0053] 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 rise and fall 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.

[0054] Wu Yao: 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.

[0055] 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 jiao. By lowering qi, it regulates the ascending and descending balance of qi in the middle jiao. This not only assists in clearing dampness and qi stagnation in the middle jiao during the rise of yang qi, but also prevents excessive upward movement of qi, ensuring orderly ascending and descending of qi in the middle jiao and stable circular motion in the middle jiao.

[0056] 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, and 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] The overall formula warms the middle and strengthens the body, regulates Qi and relieves stagnation, embodying the balanced TCM approach of "warming without drying, unblocking without harshness." It is suitable for non-oral interventions to restore postoperative intestinal function, enhancing patient comfort and compliance. It adheres to the therapeutic principle of "regulating the middle and strengthening the body, warming Yang and promoting Qi, and clearing the bowels and removing stagnation," offering both practicality and theoretical support.

[0061] The beneficial effects of the present invention are:

[0062] The present invention combines traditional Chinese medicine syndrome differentiation theory with modern ERAS rehabilitation pathways, and proposes a Chinese medicine patch that can promote qi circulation, remove stagnation, warm yang and dispel cold. It is applied externally at the Shenque acupoint for postoperative patients, and has the clinical advantages of convenient operation, high safety and good compliance. It innovatively solves the problem of slow recovery of intestinal function after surgery. The drug of the present invention can help dredge the qi mechanism, promote intestinal peristalsis, and relieve uncomfortable symptoms such as abdominal distension and constipation after surgery. It complies with the treatment principle of Chinese medicine of "harmony of spleen and stomach, dredging the qi mechanism, and promoting intestinal recovery", and is particularly suitable for postoperative patients with spleen and stomach yang deficiency, yangming deficiency cold, and qi stagnation and blood stasis. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 Postoperative flatulence time in patients undergoing abdominal surgery (*: There was a statistically significant difference between the two groups, P < 0.05). DETAILED DESCRIPTION

[0064] Example 1 Preparation of the Chinese medicine composition patch of the present invention

[0065] Weigh the following Chinese medicinal ingredients: cloves 211g, fennel 211g, costus root 105g, lindera 63g, cyperus rotundus 63g, magnolia bark 63g, and borneol 11g, grind, sieve, and mix. Each patch contains 5.5g of the Chinese medicinal powder, supplemented with 3.5g of honey and an appropriate amount of matrix to prepare the patch.

[0066] The preparation method includes: removing impurities and coarsely crushing the raw materials of traditional Chinese medicine; grinding and passing through an 80-mesh sieve to obtain uniform fine powder; uniformly mixing the powders of the raw materials according to a ratio; applying the ointment on a non-woven fabric substrate and cutting it into 6 cm × 4 cm patches.

[0067] Example 2 Preparation of the Chinese medicine composition patch of the present invention

[0068] Weigh the following Chinese medicinal raw materials: 168 g of cloves, 168 g of fennel, 84 g of costus root, 50 g of lindera stalk, 50 g of cyperus rotundus, 50 g of magnolia bark, and 8 g of borneol, and prepare a patch according to the method of Example 1.

[0069] Example 3 Preparation of the Chinese medicine composition patch of the present invention

[0070] Weigh the following Chinese medicinal materials: 254 g of cloves, 254 g of fennel, 126 g of costus root, 76 g of lindera stalk, 76 g of cyperus rotundus, 76 g of magnolia bark, and 14 g of borneol, and prepare a patch according to the method of Example 1.

[0071] The beneficial effects of the present invention are demonstrated through clinical trials below.

[0072] Test Example 1 Clinical trial of the Chinese medicine composition of the present invention

[0073] A prospective, randomized, controlled, single-blind clinical study was conducted at West China Hospital of Sichuan University from December 2024 to March 2025, and 52 patients who met the inclusion criteria underwent abdominal surgery.

[0074] 1. Research subjects

[0075] 1.1 Inclusion criteria

[0076] 1) Age 18–70 years old;

[0077] 2) undergoing first abdominal surgery;

[0078] 3) Signed informed consent within 1 day before surgery;

[0079] 4) No history of severe gastrointestinal disease before surgery;

[0080] 5) No local skin damage or infection of the Shenque.

[0081] 1.2 Exclusion criteria

[0082] 1) Pregnant or breastfeeding women;

[0083] 2) Those who require endotracheal intubation and transfer to the ICU;

[0084] 3) Severe allergies or known allergies to Chinese medicine ingredients;

[0085] 4) Patients with severe liver and kidney dysfunction;

[0086] 5) Combined with severe complications such as malignant tumors and peritonitis.

[0087] 2. Case sample size

[0088] • Experimental group: 13 cases

[0089] • Control group 1 (placebo control): 13 cases

[0090] • Control group 2 (traditional prescription control): 11 cases

[0091] • Blank control group (only conventional treatment): 15 cases

[0092] • Total sample size: 52 cases

[0093] 3. Grouping and intervention

[0094] 3.1 Grouping

[0095] Random grouping was performed using a computer random number method, and the trial allocation personnel were separated from the treatment personnel to ensure a single-blind design.

[0096] 3.2 Intervention plan

[0097] Groups and interventions

[0098] The experimental group used the Qi-promoting and relieving patch prepared in Example 1 to apply to the Shenque acupoint. The unit dose of each patch was 20g of ointment (containing 5.5g of Chinese medicine powder, 3.5g of honey, and the rest were excipients and carriers). One patch was used daily, applied to the Shenque acupoint for 6-8 hours each time, and applied continuously for 3 days or until gas and defecation were eliminated.

[0099] Control group 1: Glutinous rice flour + fennel simulated patch was used, with the same appearance and dosage.

[0100] Control group 2: Magnolia officinalis + stir-fried Atractylodes lancea + clove + fennel patch with the same dosage.

[0101] Blank control group: routine ERAS postoperative management, without dressing intervention.

[0102] 3.3 Patch formulation and preparation

[0103] Group formula Blank control group none Control group 1 211g fennel seeds, 789g glutinous rice flour, mix into a paste and divide into portions Control group 2 Mix 50g of Magnolia officinalis, 50g of fried radix schizonepetae, 30g of cloves, and 250g of cumin, and grind into powder experimental group Cloves 211g, Citronella 211g, Costus root 105g, Lindera 63g, Magnolia officinalis 63g, Cyperus rotundus 63g, Borneol 11g, Honey 168g

[0104] 4. Statistical analysis

[0105] 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.

[0106] Enumeration data were expressed as number of cases and percentages, and the χ² test was used;

[0107] The significance level was set at P<0.05.

[0108] 5. The results are shown in Table 1 and Table 2. Figure 1 .

[0109] Table 1 Postoperative flatus time of all included patients (min)

[0110] 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 flatus time (min) 5263±1587 5433±1861 5097±1530 3915±1158

[0111] Table 2 Basic information of patients undergoing abdominal surgery and duration of postoperative flatulence

[0112] 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 time (minutes) 5263±1587 5433±1861 5097±1530 3915±1158 Adverse event rate 0.0% 0.0% 12.5% 0.0%

[0113] Note: N: number of cases. Adverse events: In control group 2, one patient developed contact dermatitis after application.

[0114] 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).

[0115] 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.

[0116] Control group 1: Fennel (Fennel) has the effects of warming yang, dispersing cold, promoting qi and relieving pain, but its single herb effect is weak;

[0117] Control group 2: Traditional Qi-promoting, digestive-promoting, and bowel-clearing drugs. Magnolia officinalis can dry out dampness, dissipate fullness, and promote the flow of Qi; stir-fried Citrus aurantium can dissipate Qi stagnation and relieve chest and abdominal discomfort; cloves and fennel can warm the middle and stop vomiting, and regulate cold stagnation. The results showed that this control group was less effective than the experimental group, suggesting that Qi-promoting drugs are the core, but Yang-warming, blood-regulating, and collateral-clearing drugs are still needed in synergy.

[0118] The experimental group: The raw material formula of the present invention is composed of five synergistic effects: promoting qi circulation, warming yang, activating blood circulation, promoting osmosis, and regulating the middle meridian. Among them, costus root, magnolia bark, fennel, and clove can promote qi circulation and relieve stagnation; lindera striata and clove can warm yang and relieve pain; cyperus rotundus can regulate qi and relieve depression; and borneol can promote absorption and promote resuscitation. The experimental group had the shortest flatulence time and the best effect, demonstrating that the present invention conforms to the TCM triple mechanism of "syndrome differentiation and prescription + acupoint stimulation + transdermal drug delivery". The present invention uses Shenque acupoint as a specific external treatment point, and the combination of drugs forms a closed-loop path of "external treatment of internal diseases". The synergistic effect of the multiple raw materials is far superior to that of single herbs or simple prescriptions, conforming to the "multi-pathway conditioning" pathogenesis of postoperative deficiency and stagnation.

[0119] The Golden Chamber states that "after any serious illness, exhaustion is the most severe," and postoperative recovery requires a balance between "regulating the middle and strengthening the body," and "clearing the stagnation and removing the stagnation." Abdominal surgery often results in "weakness of the Yangming bowel qi, and qi stagnation and dampness obstruction." Qi stagnation is the primary symptom in the early postoperative period, and treatment should prioritize "moving qi, and warming yang to assist." The Shenque acupoint is selected for its ability to clear the triple energizer, strengthen spleen yang, and regulate qi and blood, making it a key acupoint for external treatment. Acupoint application can stimulate skin nerve endings and activate the gut-brain axis reflex; ingredients such as cloves, fennel, and magnolia bark have intestinal motility-promoting, anti-inflammatory, and analgesic effects; borneol can increase capillary permeability and enhance the skin absorption rate of active ingredients; and honey, a natural skin-friendly matrix, helps stabilize the release rate of the patch. Clinical results showed that the Chinese medicine patch of the present invention can significantly shorten the time of flatus after surgery (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 motility and relieving abdominal distension in the early postoperative period, has no obvious adverse reactions, and has good safety. Its therapeutic mechanism is related to the synergy of acupoint stimulation + transdermal absorption + multi-target pharmacological effects.

Claims

1. A Chinese medicinal composition for external use for promoting intestinal function recovery in patients undergoing abdominal surgery, 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 seeds, 84-126 parts of costus roots, 50-76 parts of lindera stalks, 50-76 parts of cyperus rotundus, 50-76 parts of magnolia bark, and 8-14 parts of borneol.

2. The external-use Chinese medicinal composition for promoting postoperative intestinal function recovery in patients undergoing abdominal surgery according to claim 1, characterized in that: It is prepared from the following raw materials in the following weight ratio: 211 parts of cloves, 211 parts of fennel seeds, 105 parts of costus roots, 63 parts of lindera stalks, 63 parts of cyperus rotundus, 63 parts of magnolia bark, and 11 parts of borneol.

3. The external-use Chinese medicinal composition for promoting postoperative intestinal function recovery in patients undergoing abdominal surgery according to claim 1 or 2, characterized in that: It is prepared from the raw drug powder, water or organic solvent extract of the raw drug as active ingredients, and pharmaceutically acceptable excipients or auxiliary ingredients to form a commonly used external preparation in medicine.

4. The external-use Chinese medicinal composition for promoting postoperative intestinal function recovery in patients undergoing abdominal surgery according to claim 3, characterized in that: The auxiliary material is honey.

5. The external-use Chinese medicinal composition for promoting postoperative intestinal function recovery in patients undergoing abdominal surgery according to claim 3, characterized in that: The external preparation is a patch.

6. A method for preparing the external-use Chinese medicinal composition for promoting intestinal function recovery in patients undergoing abdominal surgery according to any one of claims 1 to 5, characterized in that: It includes the following steps: a. Weigh the APIs of various weight ratios; b. Powdering or adding water or organic solvent to extract, and then adding pharmaceutically acceptable excipients or auxiliary ingredients to prepare a patch.

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

8. The use according to claim 7, characterized in that: The medicine is used for treating Yangming deficiency-cold syndrome and gastrointestinal dysfunction caused by spleen and stomach yang deficiency.

9. The use according to claim 7, characterized in that: The medicine is used to relieve the symptoms of postoperative intestinal paralysis, abdominal distension, constipation and weak defecation.

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