A traditional Chinese medicine composition for preventing and treating postoperative hemorrhage of digestive tract mucosa and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for preventing and treating postoperative hemorrhage of digestive tract mucosa and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of Bletilla striata, 10-15 parts of Trewia nudiflora, 3-5 parts of Rhus galla, 3-5 parts of dragon's blood, 10-15 parts of Rubus corchorifolius and 10-15 parts of Callicarpa macrophylla. The application further provides two preparation methods of the traditional Chinese medicine composition, which are respectively used to prepare a powder or an aqueous agent for direct spraying under an endoscope. Animal experiments and clinical tests show that the traditional Chinese medicine composition can significantly shorten the complete hemostasis time of a wound, reduce the ulcer area after operation, reduce the serum inflammatory factor level, promote the regeneration of mucosal epithelium, does not interfere with the whole body blood coagulation function and has good safety. The application precisely adapts to the pathological characteristics of the wound of the digestive tract endoscopy after operation, has the dual functions of instant hemostasis and long-acting repair, and has a good clinical application prospect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for preventing and treating postoperative bleeding of the gastrointestinal mucosa and its preparation method. Background Technology

[0002] With the continuous innovation and popularization of digestive endoscopy diagnosis and treatment technology, the clinical detection rate and endoscopic cure rate of mucosal lesions such as gastrointestinal erosion, hyperplastic polyps, and early cancer have been greatly improved. At present, minimally invasive procedures such as cold biopsy forceps resection (CFP), cold snare resection (CSP), endoscopic mucosal resection (EMR), and endoscopic submucosal dissection (ESD) have become the preferred treatment options for gastrointestinal mucosal lesions due to their advantages of small trauma, high precision, and rapid postoperative recovery. They can effectively remove lesions and block the progression of diseases.

[0003] However, endoscopic mucosal minimally invasive surgery still has significant postoperative complications, among which postoperative bleeding is the most common and critical. It is divided into early and delayed bleeding, which can lead to hemorrhagic anemia and even shock in severe cases, and is a core factor affecting surgical efficacy and prolonging hospital stays. Fundamentally, postoperative wounds on the digestive tract mucosa possess unique high-risk bleeding characteristics with complex and diverse causes. Histologically, the digestive tract mucosa has a rich vascular network and ample blood supply. Procedures such as EMR and ESD can cause extensive defects in the mucosal layer and even the submucosa. Intraoperative electrothermal damage can lead to incomplete closure of microvessels and residual vascular fragments, providing an anatomical basis for postoperative bleeding. Simultaneously, the mucosal tissue is delicate, and newly formed granulation tissue is fragile and richly vascularized, exhibiting extremely poor resistance to traction and irritation, making it highly susceptible to rupture and bleeding. From a physiological perspective, continuous gastrointestinal peristalsis and repeated traction and friction on the wound surface can easily lead to premature eschar detachment and vascular rupture. Continuous secretion of gastric and intestinal fluids, particularly acidic gastric juices, corrodes exposed blood vessels and dissolves eschar, disrupting the wound's coagulation homeostasis and significantly increasing the probability of bleeding. Furthermore, individual patient factors cannot be ignored: for example, postoperative blood pressure fluctuations in patients with hypertension can easily lead to vascular rupture; diabetic patients experience delayed healing and increased bleeding due to microcirculatory disturbances and abnormal coagulation function; and long-term use of anticoagulants or antiplatelet drugs suppresses coagulation mechanisms, significantly increasing the risk of bleeding. Local tissue edema and necrosis caused by intraoperative electrocoagulation burns and titanium clips can also easily induce delayed bleeding when necrotic tissue sloughs off. Postoperative external factors such as improper diet, strenuous activity, and emotional fluctuations further exacerbate the bleeding risk.

[0004] For postoperative bleeding, the current clinical approach mainly involves endoscopic symptomatic hemostasis, commonly including electrocoagulation, spraying the wound with sucralfate suspension gel or other protective medications, local injection of adrenaline, and closure of the wound with titanium clips. While these methods can achieve hemostasis, they are all invasive and remedial interventions with significant clinical limitations. On the one hand, a second endoscopic procedure can cause further irritation and damage to the patient's digestive tract mucosa, exacerbating physical pain and potentially interfering with the normal postoperative healing process. On the other hand, additional hemostasis procedures, the use of high-value consumables, and prolonged postoperative monitoring significantly increase medical costs, increasing the economic burden on patients. Furthermore, they directly prolong hospital stays, consume more medical resources, and are detrimental to improving treatment efficiency and controlling medical costs.

[0005] In recent years, Traditional Chinese Medicine (TCM) has seen increasingly widespread application in the fields of gastrointestinal mucosal damage repair, hemostasis, anti-inflammation, and wound healing, thanks to its unique advantages such as holistic conditioning, addressing both the symptoms and root causes, and safety and low toxicity. Compared to the single intervention mode of Western medicine's symptomatic hemostasis, TCM can exert a comprehensive effect of astringing and stopping bleeding, removing blood stasis and protecting the mucosa, anti-inflammation and promoting tissue regeneration, and regulating the gastrointestinal tract through multiple components, multiple targets, and multiple pathways. It can not only quickly control wound bleeding, but also repair damaged mucosa and improve the local microenvironment, and avoid the secondary damage and high cost of consumables of conventional hemostasis methods, making it a research hotspot in the prevention and treatment of postoperative complications.

[0006] However, existing hemostatic and mucosal-protective traditional Chinese medicine preparations have significant shortcomings in dosage form and compatibility, severely restricting their widespread application in this specific scenario. Firstly, most commercially available products are conventional dosage forms such as oral decoctions, granules, and capsules. Patients often need to fast after endoscopy, and oral administration can easily stimulate gastrointestinal motility and digestive gland secretion, increasing the risk of bleeding. Secondly, postoperative patients often experience nausea, abdominal distension, and other symptoms, and their overall gastrointestinal function is weak. Oral administration requires systemic metabolism, making it difficult to reach the surgical wound in a timely and sufficient manner, resulting in extremely low local drug concentrations, slow onset of action, and significantly reduced hemostatic and repair effects. Thirdly, oral preparations are easily diluted or destroyed in gastric acid and intestinal fluid, resulting in significant loss of active ingredients and low bioavailability, making it difficult to provide effective protection during the critical postoperative bleeding window. Fourthly, existing topical preparations, such as suspension gels or... Sprays generally suffer from poor mucosal adhesion, short gastric retention time, and easy erosion by gastrointestinal motility and dissolution by digestive juices, making it impossible to form a durable and stable protective layer on the wound. For postoperative wounds that are continuously subjected to acid erosion and mechanical friction, the repair effect is very limited. Fifth, most existing Chinese medicine preparations are general hemostatic products, lacking specific formulation designs for the special pathological characteristics of "delicate wound surface, exposed vascular stumps, continuous erosion by gastric acid, and repeated bleeding" after gastrointestinal endoscopy. The synergy between the hemostatic, anti-inflammatory, mucosal protective, and tissue regeneration components is insufficient, making it difficult to meet the clinical needs of "immediate hemostasis" and "long-term healing". Postoperative wound healing is slow and the bleeding recurrence rate remains high.

[0007] In summary, the current clinical field lacks a traditional Chinese medicine preparation that is highly targeted, has excellent mucosal adhesion, is acid and erosion resistant, has a rapid onset of action, is suitable for endoscopic procedures, and is specifically designed for postoperative wounds on the digestive tract mucosa. Therefore, developing a specialized traditional Chinese medicine powder that combines rapid hemostasis, long-lasting mucosal protection, anti-inflammatory, and tissue-regenerating effects is of significant clinical importance and has broad application prospects for effectively controlling the risk of early and delayed postoperative bleeding, accelerating wound healing, shortening the recovery period, and reducing medical costs. Summary of the Invention

[0008] The purpose of this invention is to provide a traditional Chinese medicine composition and its preparation method for preventing and treating postoperative bleeding of the gastrointestinal mucosa, in order to solve the problems existing in the prior art. By scientifically combining six traditional Chinese medicinal materials, namely Bletilla striata, Ampelopsis japonica, Galla chinensis, Dragon's Blood, Blood-Scented Smilax glabra, and Callicarpa macrophylla, and applying them in powder or liquid form, it can effectively prevent and treat postoperative bleeding of the gastrointestinal mucosa, overcoming the technical problem that existing hemostatic preparations cannot achieve both immediate hemostasis and long-term healing.

[0009] To achieve the above objectives, the present invention provides the following solution: This invention provides a traditional Chinese medicine composition for preventing and treating postoperative bleeding of the gastrointestinal mucosa, made from the following raw materials in parts by weight: 10-20 parts of Bletilla striata, 10-15 parts of Ampelopsis japonica, 3-5 parts of Galla chinensis, 3-5 parts of Dragon's Blood, 10-15 parts of Hedyotis diffusa, and 10-15 parts of Callicarpa macrophylla.

[0010] Preferably, it is made from the following raw materials in parts by weight: 17 parts Bletilla striata, 13 parts Ampelopsis japonica, 3 parts Gallnut, 4 parts Dragon's Blood, 13 parts Blood-Seeing Sorrow, and 12 parts Large-leaved Purple Callicarpa.

[0011] The present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: (1) The six Chinese medicinal materials, namely Bletilla striata, Ampelopsis japonica, Galla chinensis, Dragon's Blood, Blood-Seeing Sorrow, and Large-leaved Purple Callicarpa, were pre-treated by washing and draining. (2) Mix the pretreated medicinal materials evenly according to the ratio, perform low-temperature ultra-fine pulverization, and sieve to obtain fine powder of medicinal materials; (3) Dry, sterilize and remove dust from the sieved medicinal powder; (4) Seal and package separately to obtain the product.

[0012] Preferably, in step (2), the temperature of the low-temperature ultrafine pulverization is below 40°C, and the sieving is through a 300-mesh sieve.

[0013] The present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: (1) The six Chinese medicinal materials, namely Bletilla striata, Ampelopsis japonica, Galla chinensis, Smilax china, and Callicarpa macrophylla, were pretreated by washing and draining. (2) Soak the pretreated Bletilla striata, Ampelopsis japonica, Galla chinensis, Smilax china, and Callicarpa macrophylla in water, decoct, filter, and collect the filtrate; (3) Crush the dragon's blood into a fine powder, add it to the filtrate obtained in step (2), mix well, and you will get the product.

[0014] Preferably, in step (2), the decoction is performed twice. The first decoction is performed by bringing the mixture to a boil over high heat and then simmering it over low heat for 25-30 minutes. The second decoction is performed by adding water, bringing the mixture to a boil, and then simmering it over low heat for 20 minutes. The two filtrates are then combined.

[0015] The present invention also provides the application of the traditional Chinese medicine composition described above or the traditional Chinese medicine composition prepared by the preparation method described above in the preparation of a drug for preventing and treating postoperative bleeding of the gastrointestinal mucosa.

[0016] Preferably, the drug is a traditional Chinese medicine powder or liquid preparation administered via endoscopic spraying.

[0017] The present invention also provides a drug for preventing and treating postoperative bleeding of the gastrointestinal mucosa, wherein the active ingredient of the drug is the aforementioned traditional Chinese medicine composition.

[0018] Preferably, the postoperative bleeding of the gastrointestinal mucosa includes bleeding after biopsy of the esophagus, stomach, duodenum and colon and rectum, bleeding after endoscopic mucosal resection, bleeding after endoscopic mucosal dissection, and bleeding from gastrointestinal ulcers.

[0019] The present invention discloses the following technical effects: This invention provides a traditional Chinese medicine composition for preventing and treating postoperative bleeding of the gastrointestinal mucosa. Compared with existing clinical prevention and treatment technologies and traditional Chinese medicine preparations, this formula has a scientific formulation, a clear target, and significant clinical efficacy. Clinical application verification shows that the total effective rate of the powdered traditional Chinese medicine composition prepared by this invention in stopping bleeding, reducing inflammation, and promoting healing of postoperative gastrointestinal mucosal wounds can reach 100%. Furthermore, the traditional Chinese medicine composition of this invention uses pure natural Chinese herbs, contains no chemical hemostatic components, does not produce drug resistance with long-term local use, has no obvious toxic side effects, and has extremely high safety. It is suitable for patients after various gastrointestinal endoscopy procedures and has a wide range of applicable populations.

[0020] The powder formulation of this invention offers significant advantages over conventional oral preparations, topical gels, sprays, and endoscopic invasive hemostasis methods. It boasts numerous benefits, including portability, convenient administration, non-invasive safety, and high patient compliance. The powder's fine texture and strong adhesion allow for direct and even application to minimally invasive surgical wounds in the digestive tract, precisely targeting bleeding and injury sites. This avoids the drawbacks of oral medications, such as gastrointestinal metabolism, significant loss of active ingredients, and low bioavailability. It also overcomes the limitations of traditional topical preparations, such as easy erosion by stomach acid and intestinal fluids and short-lasting protective film effects. The powder rapidly exerts synergistic effects of astringent hemostasis, heat-clearing and detoxifying, blood-activating and stasis-removing, and wound-healing and tissue-regenerating properties, effectively preventing early and delayed postoperative bleeding, accelerating wound mucosal repair, and significantly shortening the patient's recovery period.

[0021] Meanwhile, this invention has specifically optimized and improved the overall manufacturing process of the traditional Chinese medicine powder composition. It employs modern pharmaceutical technologies such as low-temperature pretreatment, low-temperature ultra-micro cell wall disruption pulverization, and aseptic purification. The entire process is carried out at low temperatures, which maximizes the retention of heat-sensitive active ingredients such as Bletilla striata polysaccharides, flavonoids, and tannins, avoiding the loss of efficacy caused by high-temperature processing. The optimized preparation process effectively improves the solubility, wound adhesion and release rate, and local bioavailability of the powder, allowing the drug components to be continuously and stably released from the wound surface, exerting a long-lasting hemostatic, anti-inflammatory, membrane-protecting, and tissue-regenerating effect. This completely solves the problems of slow onset of action, short-lived effects, and limited repair efficacy of existing formulations.

[0022] Compared to invasive hemostasis methods in Western medicine such as electrocoagulation, drug injection, and titanium clip closure, the traditional Chinese medicine powder composition of this invention eliminates the need for secondary endoscopic procedures, preventing secondary damage to the digestive tract mucosa. This significantly reduces the incidence of postoperative complications, alleviates patient suffering, and effectively reduces the use of clinical consumables and hospitalization time, thus lowering the patient's medical burden and conserving clinical medical resources. Clinical trials have demonstrated that the traditional Chinese medicine powder composition of this invention is effective, safe, and stable in preventing and treating postoperative bleeding of the digestive tract mucosa and promoting wound healing, exhibiting significant advantages in clinical application.

[0023] In the future, the inventors' team will further optimize the precise proportions and preparation process parameters of the traditional Chinese medicine composition, continuously improve the wound repair efficacy and patient comfort, actively expand clinical application scenarios, seek multi-party clinical cooperation, and make every effort to promote the widespread application and clinical use of this traditional Chinese medicine powder in the prevention and treatment of postoperative complications of gastrointestinal endoscopy, providing a safe, efficient, inexpensive and convenient new traditional Chinese medicine treatment solution for postoperative rehabilitation of the gastrointestinal mucosa. Attached Figure Description

[0024] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0025] Figure 1 Endoscopic images of rectal polyps and endoscopic images after the use of a traditional Chinese medicine powder composition; Figure 2 Images of the surgical wound after ESD for rectal polyps and endoscopic observation after the use of a traditional Chinese medicine powder composition. Figure 3 Endoscopic images of multiple rectal erosions and bleeding, and endoscopic images after the use of a traditional Chinese medicine powder composition; Figure 4 Endoscopic images of duodenal bulb ulcer with bleeding and endoscopic images after the use of traditional Chinese medicine powder; Figure 5 Endoscopic images of persistent bleeding after biopsy of gastric erosion and endoscopic images of the treatment with a traditional Chinese medicine composition solution. Detailed Implementation

[0026] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0027] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0028] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0029] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0030] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0031] This invention provides a traditional Chinese medicine composition for preventing and treating postoperative bleeding of the gastrointestinal mucosa, which is made from the following raw materials in parts by weight: 10-20 parts of Bletilla striata, 10-15 parts of Ampelopsis japonica, 3-5 parts of Galla chinensis, 3-5 parts of Dragon's Blood, 10-15 parts of Hedyotis diffusa, and 10-15 parts of Callicarpa macrophylla.

[0032] The above-mentioned composition is made from six authentic Chinese medicinal herbs: Bletilla striata, Ampelopsis japonica, Galla chinensis, Dragon's Blood, Blood-Scented Smilax glabra, and Callicarpa macrophylla. Each herb performs its own function and works synergistically to achieve the effects of rapid hemostasis, astringent protection of the mucosa, clearing heat and detoxifying, promoting blood circulation and removing blood stasis, and promoting wound healing and tissue regeneration. It is precisely adapted to the pathological characteristics of postoperative wounds of the digestive tract mucosa, which are fragile, prone to bleeding, prone to infection, and difficult to heal.

[0033] Bletilla striata is the principal herb, with a bitter, sweet, and astringent taste, and slightly cold properties. It enters the lung, liver, and stomach meridians and is a traditional essential medicine for mucosal repair and hemostasis in surgical wounds. This herb has a viscous texture and is rich in Bletilla striata polysaccharides and colloids, possessing extremely strong astringent and hemostatic power. It can precisely act on damaged wounds in the digestive tract, rapidly promoting platelet aggregation and shortening clotting time for immediate hemostasis. Simultaneously, it forms a dense protective film on the mucosal wound, physically isolating it from the erosion of gastric acid and intestinal fluid, as well as the frictional stimulation of gastrointestinal peristalsis, effectively locking in the efficacy of the medicine. Bletilla striata also has the effects of reducing swelling, promoting tissue regeneration, and repairing mucosa. It is astringent without causing bruising and viscous without causing stagnation, effectively promoting the regeneration of granulation tissue in damaged mucosa, accelerating wound healing, and meeting the repair needs of minimally invasive surgical wounds in the digestive tract.

[0034] Bai Lian (Radix Ampelopsis) and Wu Bei Zi (Radix Gallae) are used as assistant herbs. Bai Lian is bitter, pungent, and slightly cold in nature, and enters the Heart and Stomach meridians. It excels at clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting wound healing and tissue regeneration. It can clear postoperative wound stasis and heat, eliminate local mucosal inflammatory edema, prevent wound inflammatory infection, and create a clean environment for wound repair. Wu Bei Zi is sour, astringent, and cold in nature, and enters the Lung, Large Intestine, and Kidney meridians. Its astringent properties are extremely strong, which can effectively astringe the meridians, consolidate and stop bleeding, effectively seal tiny bleeding points on the wound, and prevent postoperative minor bleeding and delayed bleeding. At the same time, its heat-clearing and dampness-drying effects can relieve the damp-heat stagnation state of the wound, inhibit local inflammatory reactions, and help accelerate wound scab formation and healing.

[0035] Dragon's Blood, Blood-Clearing Beauty (Sanguisorba officinalis), and Large-Leaf Purple Beauty (Callicarpa macrophylla) are used as adjuvant herbs. Dragon's Blood is sweet, salty, and neutral in nature, and enters the Heart and Liver meridians. Its core functions are to invigorate blood circulation, remove blood stasis, relieve pain, stop bleeding, and promote tissue regeneration. It can resolve minor postoperative wound stasis, improve local blood stasis, and avoid the problem of blood stasis retention caused by simple astringent hemostasis, achieving the effect of "stopping bleeding without leaving blood stasis and resolving blood stasis without harming the body's vital energy." It can also relieve postoperative wound pain and swelling. Blood-Clearing Beauty (Sanguisorba officinalis) is bitter, pungent, and cool in nature. It excels at cooling the blood, stopping bleeding, detoxifying, reducing swelling, drying dampness, and promoting wound healing. It can clear heat and stagnation in the blood of the wound, showing significant effect on recurrent bleeding caused by postoperative heat and stagnation. It can also clear damp-heat stagnation in the intestines and improve the wound microenvironment. Large-leaved purple pearl is a traditional Chinese medicine from Lingnan. It is pungent, bitter and neutral in nature. It has strong hemostatic, blood stasis-dispersing, heat-clearing and detoxifying, anti-inflammatory and swelling-reducing effects. The tannins and flavonoids it contains can shrink capillaries in the wound, enhance vascular toughness, and inhibit local inflammatory exudation, further strengthening the hemostatic, anti-inflammatory and membrane-protecting effects, and reducing the risk of postoperative bleeding recurrence.

[0036] This formula, composed of six exquisitely blended medicinal herbs, exhibits a balanced combination of warming and cooling properties, and employs both tonifying and purging methods. It addresses the core pathogenesis of postoperative damage to the digestive tract mucosa, including blood stasis, inflammation, and slow wound healing. It abandons the single approach of hemostasis, achieving a synergistic therapeutic effect of hemostasis, anti-inflammation, blood stasis removal, mucosal protection, and tissue regeneration. Compared to existing formulations, the composition of this invention, when formulated as a herbal powder, can be directly sprayed or applied to the postoperative wound after endoscopy. It exhibits strong targeting, avoids first-pass metabolic loss in the gastrointestinal tract, has extremely high drug utilization, and does not cause secondary damage to the mucosa. It also boasts high safety and broad compatibility.

[0037] The formulation and application of the above composition are further illustrated below with specific examples.

[0038] Example 1: Preparation of a traditional Chinese medicine composition for preventing and treating postoperative bleeding of the gastrointestinal mucosa. The components of the traditional Chinese medicine composition are: Bletilla striata 10g, Ampelopsis japonica 10g, Galla chinensis 3g, Dragon's Blood 3g, Blood-Seeing Sorrow 10g, and Large-leaved Purple Callicarpa 10g.

[0039] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: (1) Raw material pretreatment: Select high-quality, mold-free, insect-free six Chinese medicinal materials, including Bletilla striata, Ampelopsis japonica, Galla chinensis, Dragon's Blood, Blood-Seeing Sorrow, and Large-leaved Purple Callicarpa, remove impurities and mud, quickly wash the surface dirt with purified water, and place them in a low-temperature (below 40℃, 30℃ was selected in this experiment) ventilated environment to drain the surface moisture. (2) Mix the pretreated medicinal materials evenly according to the ratio, and pulverize them using a low-temperature ultra-micro wall-breaking pulverizer. Control the grinding temperature to be below 40℃ (30℃ was selected in this experiment) to avoid high temperature damage to heat-sensitive active ingredients such as polysaccharides, flavonoids, and tannins in the medicinal materials. After grinding, pass through a 300-mesh sterile sieve to obtain fine and uniform medicinal powder. (3) Aseptic purification treatment: The sieved fine powder of medicinal materials is placed in an aseptic, dry, constant temperature purification workshop for low-temperature drying, sterilization and dust removal treatment to remove impurities and microorganisms from the powder and ensure the purity of the powder and the safety of medication. (4) Dispensing and sealing: Dispense the purified Chinese medicine powder evenly into sterile pharmaceutical sealed containers, and seal them under vacuum to obtain the finished Chinese medicine hemostatic and protective film powder.

[0040] (5) Pack the Chinese herbal hemostatic and protective film powder into a powder spray bottle (10g / bottle), store in a dry place, and the shelf life is 3 months.

[0041] Instructions for use: When using, insert the powder spray bottle into the endoscope spray tube through the endoscope working channel, connect the powder spray bottle to the spray tube, squeeze the powder spray bottle, and use pressure to cover the wound with powder.

[0042] Example 2 The components of the traditional Chinese medicine composition are: Bletilla striata 14g, Ampelopsis japonica 14g, Galla chinensis 4g, Dragon's Blood 4g, Blood-Seeing Sorrow 12g, and Large-leaved Purple Callicarpa 12g.

[0043] The preparation method is the same as that in Example 1.

[0044] The usage method is the same as that in Example 1.

[0045] Example 3 The components of the traditional Chinese medicine composition are: Bletilla striata 17g, Ampelopsis japonica 13g, Galla chinensis 3g, Dragon's Blood 4g, Blood-Seeing Sorrow 13g, and Large-leaved Purple Callicarpa 12g.

[0046] The preparation method is the same as that in Example 1.

[0047] The usage method is the same as that in Example 1.

[0048] Example 4 The components of the traditional Chinese medicine composition are: Bletilla striata 20g, Ampelopsis japonica 15g, Galla chinensis 5g, Dragon's Blood 5g, Blood-Seeing Sorrow 15g, and Large-leaved Purple Callicarpa 15g.

[0049] The preparation method is the same as that in Example 1.

[0050] The usage method is the same as that in Example 1.

[0051] Example 5 The formulation of the traditional Chinese medicine composition is the same as that in Example 1.

[0052] The preparation method includes the following steps: (1) Place all of the herbs, including Bletilla striata, Ampelopsis japonica, Galla chinensis, Angelica dahurica, and Callicarpa macrophylla, in a clay pot or enamel decoction container. Add clean drinking water, ensuring the water level is 2-3 cm above the herbs. Soak at room temperature for 30-40 minutes to allow the herbs to fully moisten. (2) First decoction: After bringing to a boil over high heat, turn to low heat and simmer for 25-30 minutes; turn off the heat, filter the liquid through gauze, and collect the first decoction. (3) Second decoction: Add an appropriate amount of warm water to the dregs, making sure the water covers the dregs, bring to a boil and simmer for 20 minutes. Filter with gauze and collect the second decoction.

[0053] (4) Mix the two filtrates and concentrate them over a low flame to a suitable volume (generally concentrate to 100mL for external use); cool to 40-50℃, then add the dragon's blood powder to the liquid and stir thoroughly (dragon's blood is difficult to dissolve in water and is used in suspension); the preparation method of the dragon's blood powder is the same as the preparation method of the powder in Example 1; (5) Pack the liquid medicine in vacuum packaging bags, divide it into 50mL / bags, and refrigerate it in the refrigerator (4℃). Shelf life is 7 days. Instructions for use: Draw 50 mL of the medication into a 60 mL syringe, insert the endoscope spray tube through the working forceps channel, and spray the medication onto the wound. A thin film will quickly form on the wound surface to stop bleeding. Because the medication will flow, the actual amount of medication applied to the wound will be less than the amount used.

[0054] Example 6 The formulation of the traditional Chinese medicine composition is the same as that in Example 2.

[0055] The preparation and usage methods are the same as those in Example 5.

[0056] Example 7 The formulation of the traditional Chinese medicine composition is the same as that in Example 3.

[0057] The preparation and usage methods are the same as those in Example 5.

[0058] Example 8 The formulation of the traditional Chinese medicine composition is the same as that in Example 4.

[0059] The preparation and usage methods are the same as those in Example 5.

[0060] animal experiments 1. Laboratory animals and grouping Animals: Healthy New Zealand White rabbits, half male and half female, weighing 2.0-2.5 kg, acclimatized for 1 week, with free access to water and standard feed.

[0061] Grouping: Randomly divided into 3 groups, with 10 animals in each group.

[0062] Control group (sham surgery group): only gastroscopy was performed, no model was created, and no medication was administered.

[0063] Model group (modeling + blank carrier): A bleeding model after mucosal resection was created under gastroscopy, and an equal amount of physiological saline was sprayed after the operation.

[0064] Experimental group (modeling + powder prepared in Example 3): After modeling in the same way, the powder of Example 3 (at a rate of 0.5 g / kg body weight) was immediately and evenly applied to the wound surface through the endoscopic spray tube.

[0065] 2. Model establishment (postoperative bleeding model after endoscopic mucosal resection) (1) The animals are fasted for 24 hours, but water is allowed.

[0066] (2) Intravenous anesthesia (sodium pentobarbital 30mg / kg), fixed on the operating table.

[0067] (3) Insert an ultra-thin gastroscope through the mouth and select a circular mucosal area with a diameter of about 5 mm on the anterior wall of the gastric antrum.

[0068] (4) Use a snare to perform cold excision of the mucosa (without electrocoagulation) to create a standardized wound with a depth reaching the submucosa and visible active bleeding (the bleeding score ≥2 is the standard for successful modeling, see Table 1).

[0069] Table 1 Scoring Criteria (5) The drug was administered within 30 seconds after modeling (the experimental group was sprayed with powder, and the model group was sprayed with an equal amount of physiological saline), while the control group was only touched by the endoscope without resection.

[0070] 3. Administration method Experimental group: Using an endoscopic spray tube, the powder (passed through a 300-mesh sieve) of Example 3 was blown onto the wound surface with sterile compressed air to completely cover it.

[0071] Model group: The same volume of physiological saline was sprayed using the same method.

[0072] Control group: No treatment was given.

[0073] 4. Observation indicators and detection time points (1) Hemostatic effect The specific indicators are: ① Wound bleeding score (0-3 points); ② Time to complete hemostasis (the number of seconds from drug administration to the cessation of active bleeding).

[0074] Detection time: immediately after administration, 5 min, 15 min, and 30 min.

[0075] (2) Wound protection and healing Specific indicators are: ① A second gastroscopy 72 hours post-surgery to observe the ulcer area (measured using ImageJ software, mm). 2); ② Wound histopathological scoring (HE staining, scored from 0 to 4 points according to inflammatory infiltration, granulation thickness, and degree of epithelial regeneration).

[0076] Testing time: Animals were euthanized 72 hours after the operation for sample collection.

[0077] (3) Inflammation and coagulation markers Specific indicators are: ① Blood was drawn from the marginal ear vein 24 hours post-surgery to detect serum TNF-α and IL-6 (ELISA kit). ② Prothrombin time (PT) and activated partial thromboplastin time (APTT).

[0078] Testing time: 24 hours after the operation.

[0079] (4) Safety The specific indicators are: ① Observe the animal's general behavior, food intake, and weight changes after administration; ② Pathological examination of major organs (heart, liver, and kidneys).

[0080] Testing time: Observe throughout the process, and collect samples after 72 hours.

[0081] 5. Statistical Analysis Results are expressed as mean ± standard deviation (x̄ ± s). One-way ANOVA was used for comparisons among multiple groups, and LSD-t tests were used for pairwise comparisons. Kruskal-Wallis rank-sum tests were used for bleeding score ordination data. P A value <0.05 is considered statistically significant.

[0082] 6. Results and Analysis (1) Hemostatic effect Table 2 Comparison of wound bleeding scores at different time points after surgery in each group (x̄±s, n=10) Note: Compared to the model group, ## P <0.01.

[0083] As shown in Table 2, the bleeding in the model group decreased slowly and self-limitingly due to the lack of effective hemostasis intervention, but there was still significant oozing at 30 minutes. In the experimental group, bleeding was significantly controlled within 5 minutes after administration, and the bleeding was significantly lower than that in the model group.

[0084] (2) Wound protection and healing Table 3 Comparison of complete hemostasis time and wound healing indices among the groups (x̄±s, n=10) Note: Compared to the model group ** P<0.01. Pathological healing scoring criteria: 0 points = no healing, 1 point = a small amount of granulation tissue, 2 points = granulation tissue + a small amount of epithelium, 3 points = significant epithelial regeneration + mild inflammatory cells, 4 points = complete epithelialization + no inflammation.

[0085] As shown in Table 3, compared with the model group, the time to complete hemostasis in the experimental group was significantly shorter at 72 h postoperatively; the ulcer area in the experimental group was smaller than that in the model group (P<0.05), and the pathological scores showed reduced inflammatory cell infiltration, significant granulation tissue proliferation, and high degree of epithelialization.

[0086] (3) Inflammatory factors and coagulation function Table 4 Comparison of serum inflammatory factors and coagulation function in each group 24 h postoperatively (x̄±s, n=10) Note: Compared with the control group, ## P <0.01; compared with the model group, ** P <0.01.

[0087] As shown in Table 4, the serum TNF-α and IL-6 levels in the experimental group were lower than those in the model group (P<0.05), indicating that local inflammation was well controlled. There were no significant differences in PT and APTT among the three groups (P>0.05), indicating that the powder in Example 3 of this invention does not interfere with the systemic coagulation system and has good safety.

[0088] Pathological tissue observation results showed that the experimental group had a film of powder attached to the wound, and there was no abnormal necrosis or foreign body granuloma in the submucosa.

[0089] In summary, this invention, through a rabbit model of postoperative bleeding after endoscopic mucosal resection, clearly demonstrates that the powder in Example 3 can quickly stop bleeding, promote wound healing, reduce local inflammation, and has good safety, making it suitable for the prevention and treatment of postoperative bleeding of the gastrointestinal mucosa.

[0090] Clinical trials The clinical samples are shown in Table 5. These were all patients who visited the Department of Gastroenterology at the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine and required gastroscopy and colonoscopy. Preoperative blood tests, coagulation function tests, electrolyte tests, four infectious agents, and electrocardiograms were performed to rule out contraindications for gastroscopy and colonoscopy. Informed consent forms for the gastroscopy, colonoscopy, treatment, and medication were signed before the procedure. After the endoscopic procedure, the patient was immediately given a liquid or powder formulation of the traditional Chinese medicine composition, depending on the size of the postoperative wound. Due to the larger wounds from ESD, ulcers, and erosions, powder was more commonly used for hemostasis, while liquid formulation was more frequently used for biopsy wounds, which were smaller.

[0091] Furthermore, the diagnosis was confirmed according to the corresponding diagnostic criteria. Patient consent was obtained for all medications administered.

[0092] Table 5 Clinical Sample Information The results showed that in all the above samples, regardless of whether powder or liquid was used to treat the aforementioned gastrointestinal tract injuries, no early or delayed bleeding was observed, achieving a 100% bleeding prevention rate. The efficacy of powder and liquid formulations can be found in [the table below]. Figures 1-5 (Some representative images).

[0093] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for preventing and treating postoperative bleeding of the gastrointestinal mucosa, characterized in that, It is made from the following raw materials in parts by weight: 10-20 parts of Bletilla striata, 10-15 parts of Ampelopsis japonica, 3-5 parts of Galla chinensis, 3-5 parts of Dragon's Blood, 10-15 parts of Blood-Seeing Sorrow, and 10-15 parts of Large-leaved Purple Callicarpa.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, It is made from the following ingredients in parts by weight: 17 parts Bletilla striata, 13 parts Ampelopsis japonica, 3 parts Gallnut, 4 parts Dragon's Blood, 13 parts Blood-Seeing Sorrow, and 12 parts Large-leaved Purple Callicarpa.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (1) The six Chinese medicinal materials, namely Bletilla striata, Ampelopsis japonica, Galla chinensis, Dragon's Blood, Blood-Seeing Sorrow, and Large-leaved Purple Callicarpa, were pre-treated by washing and draining. (2) Mix the pretreated medicinal materials evenly according to the ratio, perform low-temperature ultra-fine pulverization, and sieve to obtain fine powder of medicinal materials; (3) Dry, sterilize and remove dust from the sieved medicinal powder; (4) Separately package and seal to obtain the product.

4. The preparation method according to claim 3, characterized in that, In step (2), the temperature of the low-temperature ultrafine pulverization is below 40°C, and the sieving is through a 300-mesh sieve.

5. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (1) The six Chinese medicinal materials, namely Bletilla striata, Ampelopsis japonica, Galla chinensis, Smilax china, and Callicarpa macrophylla, were pretreated by washing and draining. (2) Soak the pretreated Bletilla striata, Ampelopsis japonica, Galla chinensis, Smilax china, and Callicarpa macrophylla in water, decoct, filter, and collect the filtrate; (3) Crush the dragon's blood into a fine powder, add it to the filtrate obtained in step (2), mix well, and you will get the product.

6. The preparation method according to claim 5, characterized in that, In step (2), the decoction is performed twice. The first decoction is to bring the mixture to a boil over high heat and then simmer over low heat for 25-30 minutes. The second decoction is to add water, bring the mixture to a boil, and then simmer over low heat for 20 minutes. The two filtrates are then combined.

7. The use of a traditional Chinese medicine composition according to claim 1 or 2, or a traditional Chinese medicine composition prepared by any one of claims 3-6, in the preparation of a drug for preventing and treating postoperative bleeding of the gastrointestinal mucosa.

8. The application as described in claim 7, characterized in that, The drug is a traditional Chinese medicine powder or liquid medicine administered via endoscopic spraying.

9. A drug for preventing postoperative bleeding of the gastrointestinal mucosa, characterized in that, The active ingredient of the drug is the traditional Chinese medicine composition as described in claim 1.

10. The medicament as claimed in claim 9, characterized in that, Postoperative bleeding of the gastrointestinal mucosa includes bleeding after biopsy of the esophagus, stomach, duodenum and colon and rectum, bleeding after endoscopic mucosal resection, bleeding after endoscopic mucosal dissection, and bleeding from gastrointestinal ulcers.

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