An external traditional Chinese medicine dressing for improving hematoma after intervention

Abstract

The application provides a kind of nursing external use traditional Chinese medicine dressing for improving hematoma after intervention, it is related to traditional Chinese medicine pharmaceutical technical field, the traditional Chinese medicine dressing is composed of Lycopene, red peony root, salvia miltiorrhiza, chuanxiong, liverwort, giant knotweed, Uncaria, honeysuckle, mulberry branch, day lily, thistle, lalun.The mouse intervention post-hematoma model test shows that the traditional Chinese medicine dressing of the application can not only effectively accelerate the dispersion of local blood stasis, significantly promote hematoma absorption, but also significantly reduce hematoma-related inflammatory response by inhibiting the release of inflammatory factors TNF-alpha and IL-6, and create a good microenvironment for hematoma regression.Clinical research further verifies that the traditional Chinese medicine dressing of the application can quickly dissipate blood stasis, speed up the hematoma regression process, and effectively relieve related pain and discomfort, significantly improve patient experience and treatment total effective rate.In summary, the application provides a scheme with significant effectiveness and good safety for improving or treating hematoma after intervention.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine manufacturing technology, specifically to a topical traditional Chinese medicine dressing for improving post-interventional hematoma. Background Technology

[0002] Interventional therapy, guided by medical imaging equipment, utilizes catheters and guidewires inserted through an arterial sheath to precisely diagnose and treat diseased areas within the body using contrast agents, stents, embolic agents, and chemotherapy drugs. It is widely used in cardiovascular, oncology, and neurovascular fields. Compared to traditional surgery, interventional therapy only requires arterial puncture for angiography and disease management, resulting in less surgical trauma and faster recovery, leading to its increasingly widespread clinical application. However, procedures such as vascular puncture and catheter insertion inevitably damage local blood vessels, causing extravasation and hematoma formation. Clinical statistics show that the incidence of hematoma after interventional procedures ranges from 5% to 20%. This complication not only causes local swelling, pain, and ecchymosis but can also lead to vascular compression, circulatory disorders, and even secondary problems such as infection and nerve damage, significantly prolonging hospital stays, reducing treatment satisfaction, and increasing the medical burden.

[0003] Currently, clinical interventions for post-interventional hematoma mainly fall into two categories: conventional Western medicine treatment and traditional Chinese medicine treatment. In Western medicine, cold compresses are often used to stop bleeding and pressure bandages to reduce exudation during the acute phase, while warm compresses are used later to promote hematoma absorption. Anticoagulants, hemostatic agents, or anti-inflammatory analgesics are used when necessary. However, these methods have significant limitations: cold compresses and pressure bandages only relieve superficial symptoms and have limited effect on the dissipation of deep hematomas, and improper compression can easily affect local blood supply; while systemic chemical drugs can play a certain role, they may cause systemic side effects such as coagulation disorders, gastrointestinal irritation, and liver and kidney damage, especially for patients with underlying diseases, where the safety risks of medication are higher.

[0004] From the perspective of Traditional Chinese Medicine (TCM), subcutaneous hematoma at the puncture site is a collateral disease caused by injury to the collaterals from a sharp object, falling under the categories of "tendon injury" and "blood stasis syndrome." Foreign objects cause damage to local blood vessels or blood leakage outside the vessels, resulting in blood stasis that does not disperse. Prolonged subcutaneous blood stasis generates heat, leading to internal accumulation of stagnant heat, obstructing the flow of Qi, and causing local purplish swelling and pain. Based on this, TCM treatment focuses on promoting blood circulation, removing blood stasis, clearing stasis and detoxifying, promoting diuresis and reducing swelling, and nourishing blood and protecting the body's vital energy. Current TCM interventions primarily involve oral herbal decoctions, which, while improving the pathogenesis through systemic regulation, suffer from slow onset of action, low local drug concentration after gastrointestinal absorption, and intolerance in some patients with weak spleen and stomach function. Traditional external herbal remedies, while reaching the lesion directly, are often general formulas that lack precise formulation targeting the core pathogenesis of "stasis, heat, dampness, and toxins" after interventional procedures, limiting their clinical application. Therefore, this invention aims to provide a more effective, convenient, and patient-friendly solution for post-interventional hematoma. Summary of the Invention

[0005] (a) Technical problems to be solved

[0006] To address the shortcomings of existing technologies, this invention provides a topical Chinese medicine dressing for improving post-interventional hematoma care.

[0007] (II) Technical Solution

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] In a first aspect, the present invention provides a topical Chinese medicine dressing for improving post-interventional hematoma, the dressing being composed of the following raw materials in parts by weight: 15-35 parts of Lycopus lucidus, 15-35 parts of Paeonia lactiflora, 8-28 parts of Salvia miltiorrhiza, 3-22 parts of Ligusticum chuanxiong, 5-25 parts of Artemisia capillaris, 3-20 parts of Polygonum cuspidatum, 5-25 parts of Uncaria rhynchophylla, 5-25 parts of Lonicera japonica, 3-20 parts of Morus alba, 5-25 parts of Eclipta prostrata, 3-22 parts of Bidens pilosa, and 10-30 parts of Liquidambar formosana.

[0010] Specifically, the herbal dressing is composed of the following raw materials in parts by weight: 20-30 parts of Lycopus lucidus, 20-30 parts of Paeonia lactiflora, 13-23 parts of Salvia miltiorrhiza, 7-18 parts of Ligusticum chuanxiong, 10-20 parts of Artemisia capillaris, 5-15 parts of Polygonum cuspidatum, 10-20 parts of Uncaria rhynchophylla, 10-20 parts of Lonicera japonica, 5-15 parts of Morus alba, 10-20 parts of Eclipta prostrata, 7-18 parts of Bidens pilosa, and 15-25 parts of Liquidambar formosana.

[0011] Specifically, the herbal dressing is composed of the following raw materials in parts by weight: 25 parts of Lycopus lucidus, 25 parts of Paeonia lactiflora, 18 parts of Salvia miltiorrhiza, 12 parts of Ligusticum chuanxiong, 15 parts of Artemisia capillaris, 10 parts of Polygonum cuspidatum, 15 parts of Uncaria rhynchophylla, 15 parts of Lonicera japonica, 10 parts of Morus alba twigs, 15 parts of Eclipta prostrata, 12 parts of Bidens pilosa, and 20 parts of Liquidambar formosana.

[0012] Secondly, the present invention provides a method for preparing a topical Chinese medicine dressing for improving post-interventional hematoma, characterized by comprising the following steps:

[0013] (1) Weigh each Chinese herbal raw material according to the above weight proportions, remove impurities, rinse quickly with water, dry at low temperature at 40~50℃, and pulverize into coarse powder for later use;

[0014] (2) Add 8 to 10 times the amount of purified water to the crude powder of medicinal materials, soak for 30 minutes, then decoct for 1.5 hours and filter; add 6 to 8 times the amount of water to the residue and decoct for 1 hour again and filter; combine the two filtrates.

[0015] (3) The filtered drug solution was concentrated at 60~70℃ and -0.06~-0.08 MPa to a paste with a relative density of 1.15~1.30; 95% ethanol was added to the paste to make the alcohol content 60%~70%, and the mixture was allowed to stand for 24 h and refrigerated to precipitate. The supernatant was then concentrated again under reduced pressure to a paste with a relative density of 1.20~1.30.

[0016] (4) Mix the extract with the medical matrix at a ratio of 1:3 to 1:5, stir evenly in a sterile environment, coat evenly on the medical non-woven fabric substrate using a coating machine, cool and shape, cut to the appropriate size, and finally sterilize to obtain the finished external Chinese medicine dressing.

[0017] Specifically, the matrix used in step (4) is selected from one or more of the following: yellow petrolatum, carbomer, sodium alginate, and pressure-sensitive adhesive.

[0018] The pharmacological effects of each herbal raw material in the herbal dressing of this invention are as follows:

[0019] Eupatorium fortunei: The dried aerial parts of Eupatorium fortunei, a plant in the Lamiaceae family. It tastes bitter and pungent, and is slightly warm in nature. It enters the liver and spleen meridians. It has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and reducing swelling, and promoting diuresis and reducing edema. It is used for irregular menstruation, amenorrhea, dysmenorrhea, postpartum abdominal pain due to blood stasis, carbuncles and boils, and edema and ascites.

[0020] Red peony root: The dried root of Paeonia lactiflora or Paeonia veitchii, both belonging to the Ranunculaceae family. It has a bitter taste, is slightly cold in nature, and enters the liver meridian. It has the effects of clearing heat and cooling blood, dispersing blood stasis and relieving pain. It is used for heat entering the blood level, febrile rashes, hematemesis and epistaxis, red and swollen eyes, liver stagnation and hypochondriac pain, amenorrhea and dysmenorrhea, abdominal masses and pain, traumatic injuries, carbuncles and sores.

[0021] Salvia miltiorrhiza: The dried root and rhizome of Salvia miltiorrhiza, a plant in the Lamiaceae family. It tastes bitter and is slightly cold in nature, entering the heart and liver meridians; it has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling; it is used for chest pain, abdominal and hypochondriac pain, abdominal masses, arthralgia, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0022] Chuanxiong: The dried rhizome of Ligusticum chuanxiong, a plant of the Apiaceae family. It has a pungent taste and warm nature, and enters the liver, gallbladder, and pericardium meridians; it has the effects of promoting blood circulation and qi circulation, dispelling wind and relieving pain; it is used for chest pain, chest and rib pain, traumatic swelling and pain, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to masses, headache, and rheumatic pain.

[0023] Liu Ji Nu: The dried whole herb of *Liu Ji Nu*, a plant in the Scrophulariaceae family. It is bitter and cold in nature, and enters the spleen, stomach, liver, and gallbladder meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, cooling the blood, stopping bleeding, clearing heat and promoting diuresis. It is used for traumatic injuries, external bleeding, amenorrhea due to blood stasis, irregular menstruation, postpartum pain due to blood stasis, abdominal masses, bloody dysentery, hematuria, damp-heat jaundice, edema and abdominal distension, and excessive leukorrhea.

[0024] Polygonum cuspidatum: The dried rhizome and root of Polygonum cuspidatum, a plant in the Polygonaceae family. It has a slightly bitter taste and slightly cold nature, and enters the liver, gallbladder, and lung meridians. It has the effects of promoting diuresis and relieving jaundice, clearing heat and detoxifying, dispersing blood stasis and relieving pain, and relieving cough and resolving phlegm. It is used for damp-heat jaundice, urinary tract infections, leukorrhea, rheumatic arthralgia, carbuncles and boils, burns, amenorrhea, abdominal masses, traumatic injuries, and cough due to lung heat.

[0025] Uncaria rhynchophylla: The dried hooked stems and branches of Uncaria rhynchophylla, Uncaria macrophylla, Uncaria pubescens, Uncaria huashen, or Uncaria sessilea. It has a sweet taste and cool nature, and enters the liver and pericardium meridians; it has the effects of calming wind and relieving convulsions, clearing heat and soothing the liver; it is used for internal liver wind, epilepsy and convulsions, high fever convulsions, colds with convulsions, infantile convulsions, eclampsia, headache and dizziness.

[0026] Honeysuckle vine: The dried stems and branches of honeysuckle, a plant in the Caprifoliaceae family. It has a sweet taste and cold nature, and enters the lung and stomach meridians; it has the effects of clearing heat and detoxifying, dispelling wind and unblocking the meridians; it is used for febrile diseases, dysentery due to heat toxins, carbuncles and sores, rheumatic arthralgia, and red, swollen, hot and painful joints.

[0027] Mulberry twigs: Dried tender twigs of the mulberry tree (Morus alba), a plant in the Moraceae family. They have a slightly bitter taste, are neutral in nature, and enter the liver meridian; they have the effects of dispelling wind and dampness and benefiting the joints; they are used for rheumatic arthralgia, and for soreness and numbness in the shoulders, arms, and joints.

[0028] Eclipta prostrata: The dried aerial parts of Eclipta prostrata, a plant in the Asteraceae family. It has a sweet and sour taste, is cold in nature, and enters the kidney and liver meridians; it has the effects of nourishing the liver and kidneys, cooling the blood and stopping bleeding; it is used for liver and kidney yin deficiency, loose teeth, premature graying of hair, dizziness and tinnitus, soreness and weakness of the waist and knees, yin deficiency and blood heat causing hematemesis, epistaxis, hematuria, bloody dysentery, metrorrhagia, and external bleeding.

[0029] Bidens pilosa: The dried aerial parts of Bidens pilosa, a plant in the Asteraceae family. It tastes bitter and is neutral in nature, entering the liver, spleen, and large intestine meridians; it has the effects of clearing heat and detoxifying, promoting blood circulation and removing blood stasis; it is used for malaria, diarrhea, dysentery, hepatitis, acute nephritis, stomach pain, esophageal obstruction, intestinal abscess, sore throat, traumatic injuries, and snake and insect bites.

[0030] Fructus Liquidambaris: The dried and mature infructescence of Liquidambar formosana Hance of the family Hamamelidaceae. Bitter in taste, neutral in property, attributing to the liver and kidney meridians; having the effects of expelling wind and activating collaterals, promoting diuresis, and dredging channels; used for arthralgia, numbness and contracture, edema and fullness, scanty lactation, and amenorrhea.

[0031] (III) Beneficial effects

[0032] The present invention provides an externally applied traditional Chinese medicine dressing for improving hematoma after intervention. The traditional Chinese medicine dressing is composed of Eupatorium japonicum Thunb., Radix Paeoniae Rubra, Salvia miltiorrhiza, Rhizoma Chuanxiong, Herba Artemisiae Anomalae, Polygonum cuspidatum, Uncaria rhynchophylla, Lonicera japonica Thunb., Ramulus Mori, Herba Ecliptae, Bidens bipinnata, and Fructus Liquidambaris. This prescription follows the principle of treating diseases based on the root cause and taking both the symptoms and root cause into account in traditional Chinese medicine. Eupatorium japonicum Thunb. and Radix Paeoniae Rubra are used as the monarch drugs: Eupatorium japonicum Thunb. is an important drug for promoting blood circulation to remove stasis and promoting diuresis to alleviate edema. It is pungent, warm, and promotes blood circulation and qi movement without being overly drastic. It is especially good at dredging the meridians obstructed by stasis after surgery and excreting the retained dampness and toxins locally, conforming to the pathological characteristics of the mutual binding of stasis and dampness after surgery; Radix Paeoniae Rubra clears heat and cools blood, dispels stasis and relieves pain. It is bitter and cold, clearing heat and purging fire without damaging yang qi. It is good at clearing heat in stasis and breaking up firm stasis, targeting the swelling, pain, redness, and heat accompanied by hematoma. The two drugs are used in combination, one warm and one cold, one promoting diuresis and one cooling blood, forming a core pattern of promoting blood circulation without generating heat, clearing stasis without damaging yang qi, and promoting diuresis without consuming yin fluid, directly hitting the three key links of stasis, heat, and dampness in the formation of hematoma. Salvia miltiorrhiza, Rhizoma Chuanxiong, Herba Artemisiae Anomalae, and Polygonum cuspidatum are used as ministerial drugs: Salvia miltiorrhiza promotes blood circulation to remove stasis, cools blood and eliminates carbuncles; Rhizoma Chuanxiong promotes qi movement and blood circulation, dispels wind and relieves pain; Herba Artemisiae Anomalae breaks blood to dredge channels, dispels stasis and relieves pain, astringes sores and reduces swelling; Polygonum cuspidatum promotes blood circulation to stop pain, clears heat and detoxifies, promotes diuresis and reduces jaundice. The four drugs work synergistically to strengthen the effects of the monarch drugs from multiple dimensions such as promoting blood circulation and dredging collaterals, breaking stasis to stop bleeding, and clearing stasis and detoxifying, forming a compatibility system that attacks pathogens without harming healthy qi. Uncaria rhynchophylla, Lonicera japonica Thunb., Ramulus Mori, Herba Ecliptae, and Bidens bipinnata are used as assistant drugs: Uncaria rhynchophylla clears heat and soothes the liver, calms wind and relieves convulsions; Lonicera japonica Thunb. clears heat and detoxifies, disperses wind and dredges collaterals; Ramulus Mori dispels wind and dredges collaterals, promotes diuresis and alleviates edema; Herba Ecliptae nourishes the liver and kidney, cools blood and stops bleeding; Bidens bipinnata clears heat and detoxifies, dispels stasis and reduces swelling. The five drugs are used in combination, targeting both improving concurrent syndromes such as heat in stasis disturbing the liver, meridian blockage, and residual dampness and toxins, and taking care of the deficiency of yin blood after surgery, achieving a dynamic balance of expelling pathogens without harming healthy qi and strengthening healthy qi without hindering pathogen elimination. Fructus Liquidambaris is used as the guiding drug, having the effects of guiding the meridian and reconciling: It is good at dredging channels and activating collaterals, promoting diuresis and alleviating edema, can guide all drugs to reach the部位 of stasis obstruction throughout the body, and at the same time enhance the effects of the monarch drugs in promoting diuresis and alleviating edema, dredging collaterals and relieving pain, and moderate the cold and heat properties of the whole prescription, making the warm and dry drugs not overly intense and the cold and cool drugs not stagnant, ensuring the synergistic and orderly action of all drugs and the single-minded efficacy.

[0033] This study, through experiments using a mouse model of hematoma following interventional procedures and validation using multi-dimensional clinical data, systematically demonstrated the comprehensive efficacy and core advantages of the herbal dressing of this invention in improving post-interventional hematoma. Basic experiments showed that the herbal dressing not only effectively accelerates the dissipation of local blood stasis and significantly promotes hematoma absorption, but also significantly reduces hematoma-related local inflammatory responses by inhibiting the release of inflammatory factors TNF-α and IL-6, creating a favorable microenvironment for hematoma regression. Clinical studies further validated its application value; the herbal dressing of this invention can rapidly dissipate blood stasis, accelerate the hematoma regression process, and effectively relieve related pain and discomfort, significantly improving the patient's medical experience and overall treatment effectiveness. In summary, this invention provides a solution for the improvement or treatment of post-interventional hematoma that is both highly effective and has good safety. Attached Figure Description

[0034] Figure 1 The trend of hematoma volume changes in each group of mice.

[0035] Figure 2 Comparison of VAS scores between the two groups of patients; Note: Comparison with pre-treatment scores within each group. # P<0.05, ## P<0.01; compared with the control group after treatment, * P<0.05, ** P<0.01. Detailed Implementation

[0036] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Example 1

[0037] A topical Chinese medicine dressing for improving post-interventional hematoma, the dressing is composed of the following ingredients in parts by weight: 25 parts of Lycopus lucidus, 25 parts of Paeonia lactiflora, 18 parts of Salvia miltiorrhiza, 12 parts of Ligusticum chuanxiong, 15 parts of Artemisia capillaris, 10 parts of Polygonum cuspidatum, 15 parts of Uncaria rhynchophylla, 15 parts of Lonicera japonica, 10 parts of Morus alba, 15 parts of Eclipta prostrata, 12 parts of Bidens pilosa, and 20 parts of Liquidambar formosana.

[0038] The preparation method of the external herbal dressing includes the following steps:

[0039] (1) Weigh each Chinese herbal raw material according to the above weight proportions, remove impurities, rinse quickly with water, dry at low temperature at 40~50℃, and pulverize into coarse powder for later use;

[0040] (2) Add 8 times the amount of purified water to the crude powder of medicinal materials, soak for 30 min, decoct for 1.5 h using the water decoction method, and filter; add 6 times the amount of water to the residue, decoct for 1 h again, and filter; combine the two filtrates.

[0041] (3) The filtered drug solution was concentrated at 60~70℃ and -0.06~-0.08 MPa to a relative density of 1.15; 95% ethanol was added to the extract to make the alcohol content 60%, and the mixture was allowed to stand for 24 h and refrigerated to precipitate. The supernatant was then concentrated again under reduced pressure to a relative density of 1.30.

[0042] (4) Mix the extract with yellow petrolatum at a ratio of 1:3, stir evenly under sterile conditions, coat evenly on medical non-woven fabric substrate using a coating machine, cool and shape, cut to the appropriate size, and finally sterilize to obtain the finished external Chinese medicine dressing.

[0043] The yellow petrolatum used in step (4) is a medical matrix, and one or more of carbomer, sodium alginate or pressure-sensitive adhesive can also be selected. Example 2

[0044] The difference between this embodiment and Embodiment 1 is that the herbal dressing is composed of the following raw materials in parts by weight: 15 parts of Lycopus lucidus, 15 parts of Paeonia lactiflora, 8 parts of Salvia miltiorrhiza, 3 parts of Ligusticum chuanxiong, 5 parts of Artemisia capillaris, 3 parts of Polygonum cuspidatum, 5 parts of Uncaria rhynchophylla, 5 parts of Lonicera japonica, 3 parts of Morus alba twigs, 5 parts of Eclipta prostrata, 3 parts of Bidens pilosa, and 10 parts of Liquidambar formosana. Example 3

[0045] The difference between this embodiment and Embodiment 1 is that the herbal dressing is composed of the following raw materials in parts by weight: 35 parts of Lycopus lucidus, 35 parts of Paeonia lactiflora, 28 parts of Salvia miltiorrhiza, 22 parts of Ligusticum chuanxiong, 25 parts of Artemisia capillaris, 20 parts of Polygonum cuspidatum, 25 parts of Uncaria rhynchophylla, 25 parts of Lonicera japonica, 20 parts of Morus alba twigs, 25 parts of Eclipta prostrata, 22 parts of Bidens pilosa, and 30 parts of Liquidambar formosana. Example 4

[0046] The difference between this embodiment and Embodiment 1 is that the herbal dressing is composed of the following raw materials in parts by weight: 20 parts of Lycopus lucidus, 20 parts of Paeonia lactiflora, 13 parts of Salvia miltiorrhiza, 7 parts of Ligusticum chuanxiong, 9 parts of Artemisia capillaris, 7 parts of Polygonum cuspidatum, 9 parts of Uncaria rhynchophylla, 10 parts of Lonicera japonica, 7 parts of Morus alba, 9 parts of Eclipta prostrata, 8 parts of Bidens pilosa, and 15 parts of Liquidambar formosana. Example 5

[0047] The difference between this embodiment and Embodiment 1 is that the herbal dressing is composed of the following raw materials in parts by weight: 28 parts of Lycopus lucidus, 28 parts of Paeonia lactiflora, 21 parts of Salvia miltiorrhiza, 15 parts of Ligusticum chuanxiong, 18 parts of Artemisia capillaris, 13 parts of Polygonum cuspidatum, 18 parts of Uncaria rhynchophylla, 18 parts of Lonicera japonica, 12 parts of Morus alba, 20 parts of Eclipta prostrata, 15 parts of Bidens pilosa, and 25 parts of Liquidambar formosana. Example 6

[0048] The difference between this embodiment and Embodiment 1 is that the herbal dressing is composed of the following raw materials in parts by weight: 18 parts of Lycopus lucidus, 18 parts of Paeonia lactiflora, 11 parts of Salvia miltiorrhiza, 5 parts of Ligusticum chuanxiong, 7 parts of Artemisia capillaris, 5 parts of Polygonum cuspidatum, 7 parts of Uncaria rhynchophylla, 7 parts of Lonicera japonica, 5 parts of Morus alba twigs, 8 parts of Eclipta prostrata, 5 parts of Bidens pilosa, and 12 parts of Liquidambar formosana. Example 7

[0049] The difference between this embodiment and Embodiment 1 is that the herbal dressing is composed of the following raw materials in parts by weight: 32 parts of Lycopus lucidus, 30 parts of Paeonia lactiflora, 25 parts of Salvia miltiorrhiza, 18 parts of Ligusticum chuanxiong, 21 parts of Artemisia capillaris, 18 parts of Polygonum cuspidatum, 23 parts of Uncaria rhynchophylla, 23 parts of Lonicera japonica, 18 parts of Morus alba, 23 parts of Eclipta prostrata, 20 parts of Bidens pilosa, and 28 parts of Liquidambar formosana.

[0050] Experimental Example 1

[0051] 1. Materials and Methods

[0052] 1.1 Experimental Drugs

[0053] The specific compositions of the herbal dressings in Experiments 1-5 are shown below, all prepared according to the method described in Example 1:

[0054] Experimental Group 1: 25 g of Lycopus lucidus, 25 g of Paeonia lactiflora, 18 g of Salvia miltiorrhiza, 12 g of Ligusticum chuanxiong, 15 g of Artemisia capillaris, 10 g of Polygonum cuspidatum, 15 g of Uncaria rhynchophylla, 15 g of Lonicera japonica, 10 g of Morus alba, 15 g of Eclipta prostrata, 12 g of Bidens pilosa, and 20 g of Liquidambar formosana.

[0055] Experimental Group 2: 25 g of Paeonia lactiflora, 18 g of Salvia miltiorrhiza, 12 g of Ligusticum chuanxiong, 15 g of Artemisia capillaris, 10 g of Polygonum cuspidatum, 15 g of Uncaria rhynchophylla, 15 g of Lonicera japonica, 12 g of Bidens pilosa, and 20 g of Liquidambar formosana.

[0056] Experimental Group 3: 25 g of Lycopus lucidus, 18 g of Salvia miltiorrhiza, 12 g of Ligusticum chuanxiong, 15 g of Artemisia capillaris, 10 g of Polygonum cuspidatum, 15 g of Uncaria rhynchophylla, 15 g of Lonicera japonica, 10 g of Morus alba twigs, and 15 g of Eclipta prostrata.

[0057] Experimental Group 4: 25 g of Lycopus lucidus, 25 g of Paeonia lactiflora, 15 g of Artemisia capillaris, 10 g of Polygonum cuspidatum, 15 g of Lonicera japonica, 10 g of Morus alba twigs, 15 g of Eclipta prostrata, 12 g of Bidens pilosa, and 20 g of Liquidambar formosana.

[0058] Experimental Group 5: 25 g of Lycopus lucidus, 25 g of Paeonia lactiflora, 18 g of Salvia miltiorrhiza, 12 g of Ligusticum chuanxiong, 15 g of Uncaria rhynchophylla, 10 g of Morus alba twig, 15 g of Eclipta prostrata, 12 g of Bidens pilosa, and 20 g of Liquidambar formosana.

[0059] 1.2 Laboratory Animals

[0060] Forty-two SPF-grade female mice, 10 weeks old, weighing 18–22 g. Husbandry conditions and environment: experimental temperature 20–25℃, relative humidity 40%–70%, 12 h / 12 ​​h day / night light / dark cycle.

[0061] 1.3 Preparation of subcutaneous hematoma model

[0062] Six mice were randomly selected as the blank control group. The remaining mice were anesthetized, and the right femoral artery was isolated, punctured, and a catheter was inserted. After 5 minutes, the catheter was removed, and the area was gently massaged to induce perivascular bleeding and hematoma formation. Significant local swelling, palpable fluctuation, and visible hypoechoic area on imaging indicated successful model establishment. Mice with successful model establishment were randomly divided into a model control group and experimental groups 1-5.

[0063] 1.4 Administration method

[0064] Groups 1-5 received topical application of corresponding traditional Chinese medicine dressings, while the blank control group and model control group were covered only with sterile gauze. All groups underwent dressing changes once daily for 7 consecutive days.

[0065] 1.5 Measurement of various indicators

[0066] 1.5.1 Hematoma volume

[0067] The diameter and thickness of the hematoma were measured by ultrasound at 1, 3, 5 and 7 days after modeling, and the volume was calculated.

[0068] 1.5.2 Inflammatory factors in hematoma tissue

[0069] Hematoma tissue was collected, rinsed with pre-cooled physiological saline to remove blood stains, and the water was absorbed with filter paper. Then, 9 times the amount of pre-cooled physiological saline was added, and the tissue was ground and broken up in a tissue homogenizer to prepare a 10% tissue homogenate. The levels of TNF-α and IL-6 in the hematoma tissue were detected according to the ELISA kit instructions.

[0070] 1.6 Statistical Methods

[0071] The data were processed using SPSS 25.0 software, and the experimental data were presented as follows: This indicates that one-way ANOVA was used for comparisons among multiple groups. P < 0.05 indicates that the difference is statistically significant.

[0072] 2 Results

[0073] 2.1 Hematoma volume

[0074] Depend on Figure 1It can be seen that the hematoma volume of mice in the model control group decreased slowly and remained at a high level for 1 to 7 days after administration; the hematoma volume of mice in experimental groups 1 to 5 showed a continuous and rapid shrinkage trend. Among them, the hematoma in experimental group 1 had the fastest hematoma regression rate, and the hematoma volume was reduced by about 80% from the baseline by the 7th day of intervention. The above results indicate that the herbal dressing of the present invention has a clear absorption-promoting effect on hematoma after interventional surgery.

[0075] 2.2 Inflammatory factors

[0076] As shown in Table 1, compared with the blank control group, the levels of TNF-α and IL-6 in the hematoma tissue of mice in the model control group were significantly increased (P<0.01), indicating that the hematoma model after interventional surgery was successfully constructed and the local inflammatory response was effectively activated. Compared with the model control group, the levels of TNF-α and IL-6 in the hematoma tissue of mice in experimental groups 1-5 were decreased to varying degrees (P<0.05, P<0.01), indicating that the herbal dressing of the present invention can effectively inhibit the release of local inflammatory factors TNF-α and IL-6 in the hematoma, thereby alleviating the local inflammatory response related to hematoma after interventional surgery.

[0077] Table 1 Comparison of inflammatory factor levels in hematoma tissues of mice in different groups

[0078]

[0079] Note: Compared with the blank control group ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0080] 3. Conclusion

[0081] This study systematically explored the effects of the herbal dressing of this invention on hematoma absorption and local inflammatory response using a mouse model of hematoma after interventional procedures. Experimental results showed that the herbal dressing of this invention effectively accelerated the dissipation of local blood stasis and significantly promoted the absorption of hematoma after interventional procedures. Furthermore, it significantly reduced the inflammatory response related to hematoma after interventional procedures by inhibiting the release of local inflammatory factors TNF-α and IL-6, creating a favorable local microenvironment for hematoma regression. Further analysis revealed that the complete formulation (i.e., Experimental Group 1) had the most significant overall efficacy, exhibiting the fastest hematoma regression, the strongest anti-inflammatory effect, and no abnormal reactions such as local skin irritation. In contrast, Experimental Groups 2-5, lacking some of the herbal ingredients in the formulation, showed varying degrees of weakened hematoma absorption efficiency and anti-inflammatory effect. This indicates that the formulation design of the herbal dressing of this invention is scientifically sound, and that the various herbal components do not act alone but synergistically exert a comprehensive therapeutic effect on hematoma after interventional procedures; none of them can be omitted.

[0082] Experimental Example 2

[0083] 1. Materials and Methods

[0084] 1.1 Clinical Data

[0085] 120 patients who developed hematoma after interventional surgery were randomly divided into a control group and an observation group, with 60 patients in each group. The control group consisted of 22 males and 38 females, aged 42–78 years, with a mean age of (61.37±7.83) years. The observation group consisted of 28 males and 32 females, aged 48–81 years, with a mean age of (62.48±6.25) years. There were no statistically significant differences in general characteristics between the two groups (P>0.05), making them comparable.

[0086] 1.2 Inclusion Criteria

[0087] Hematoma at the puncture site occurred within 24 hours after peripheral vascular / coronary intervention; participants voluntarily participated in this study and signed an informed consent form.

[0088] 1.3 Exclusion Criteria

[0089] Severe heart, liver, or kidney dysfunction; combined with severe coagulation disorders; severe cognitive impairment, unable to cooperate with treatment; allergic to or with allergic constitution to the herbal dressing of this invention; pregnant / lactating women; other serious postoperative complications; or use of other topical medications that promote blood circulation and remove blood stasis within the past week.

[0090] 1.4 Treatment methods

[0091] Control group: The intervention was performed using conventional magnesium sulfate warm compresses. Specific procedure: First, the skin in the interventional area was cleaned with saline solution. After the skin dried naturally, sterile gauze was completely soaked in 50% magnesium sulfate solution, wrung out until it was no longer dripping, and then warm compresses were applied (the compress temperature was controlled at 38-40℃). The gauze was ensured to completely cover the hematoma area. This was done once daily for 15-20 minutes each time, for 7 consecutive days.

[0092] Observation group: Intervention was performed using the external herbal dressing of this invention. The specific composition of the herbal dressing was as follows: 25 g of Lycopus lucidus, 25 g of Paeonia lactiflora, 18 g of Salvia miltiorrhiza, 12 g of Ligusticum chuanxiong, 15 g of Artemisia capillaris, 10 g of Polygonum cuspidatum, 15 g of Uncaria rhynchophylla, 15 g of Lonicera japonica, 10 g of Morus alba twigs, 15 g of Eclipta prostrata, 12 g of Bidens pilosa, and 20 g of Liquidambar formosana. The preparation process of the dressing followed the method described in Example 1. Specific operation: First, the skin of the interventional area was cleaned with physiological saline. After the skin was allowed to dry naturally, the herbal dressing of this invention was applied smoothly to the hematoma site (ensuring that the dressing completely covered the hematoma area). It was changed once a day for 7 consecutive days.

[0093] 1.5 Observation Indicators

[0094] 1.5.1 Change rate of hematoma area

[0095] The maximum cross-sectional area of ​​the hematoma was precisely measured by taking photos and analyzing them using image software before treatment (D0), on day 3 (D3) and day 7 (D7) after treatment, and the area change rate was calculated. Area change rate = (area before treatment - area after treatment) / area before treatment × 100%.

[0096] 1.5.2 Pain level

[0097] Pain level was assessed using the VAS (Visual Analogue Scale), with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.

[0098] 1.5.3 Clinical efficacy

[0099] Based on the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine," the treatment is divided into three stages: Markedly effective: Pain disappears completely and hematoma completely subsides within 7 days; Effective: Pain is relieved within 7 days and hematoma partially subsides; Ineffective: Pain worsens and hematoma does not subside. The total effective rate = (Number of markedly effective cases + Number of effective cases) / Total number of cases × 100%.

[0100] 1.6 Statistical Methods

[0101] Data were processed using SPSS 23.0 statistical software. Count data were expressed as rates (%), and the χ² test was used for comparisons between two groups. Quantitative data were expressed as mean ± standard deviation. The independent samples t-test was used for comparisons between groups, and the paired t-test was used for comparisons within groups; the Mann-Whitney test was used for non-normal distributions. A p-value < 0.05 was considered statistically significant.

[0102] 2 Results

[0103] 2.1 Change rate of hematoma area

[0104] As shown in Table 2, the rate of change in hematoma area in the observation group on the 3rd and 7th days after treatment was significantly higher than that in the control group (P<0.05, P<0.01), indicating that the herbal dressing of the present invention has a significant effect on promoting hematoma regression.

[0105] Table 2 Comparison of hematoma area change rate between the two groups of patients (%)

[0106]

[0107] Note: Compared with the control group, * P<0.05, ** P<0.01.

[0108] 2.2 Pain level

[0109] Depend on Figure 2It can be seen that there was no significant difference in VAS scores between the control group and the observation group before treatment (P>0.05); after treatment, the VAS scores of both the control group and the observation group decreased significantly (P<0.05), indicating that both intervention methods can alleviate hematoma-related pain to a certain extent. However, the VAS score of the observation group was significantly lower than that of the control group (P<0.01), indicating that the herbal dressing of the present invention can more effectively and persistently reduce the degree of hematoma pain in patients.

[0110] 2.3 Clinical efficacy

[0111] As shown in Table 3, the total effective rate of treatment in the control group was 78.33%, while the total effective rate of treatment in the observation group was 91.67%, which was significantly higher than that in the control group (P<0.05).

[0112] Table 3 Comparison of clinical efficacy between the two groups of patients

[0113]

[0114] 3. Conclusion

[0115] This study validated the comprehensive advantages of the herbal dressing of this invention in the treatment of hematoma after interventional procedures using multidimensional clinical data. Specifically, it can quickly dissipate blood stasis and accelerate the hematoma regression process; effectively relieve hematoma-related pain and discomfort, and improve the patient's medical experience; and significantly improve the overall clinical treatment effectiveness, providing a safe and effective solution for the treatment of hematoma after interventional procedures.

[0116] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A topical Chinese medicine dressing for improving post-interventional hematoma, characterized in that, The herbal dressing is composed of the following raw materials in parts by weight: 15-35 parts of Lycopus lucidus, 15-35 parts of Paeonia lactiflora, 8-28 parts of Salvia miltiorrhiza, 3-22 parts of Ligusticum chuanxiong, 5-25 parts of Artemisia capillaris, 3-20 parts of Polygonum cuspidatum, 5-25 parts of Uncaria rhynchophylla, 5-25 parts of Lonicera japonica, 3-20 parts of Morus alba, 5-25 parts of Eclipta prostrata, 3-22 parts of Bidens pilosa, and 10-30 parts of Liquidambar formosana.

2. The external herbal dressing for improving post-interventional hematoma according to claim 1, characterized in that, The herbal dressing is composed of the following raw materials in parts by weight: 20-30 parts of Lycopus lucidus, 20-30 parts of Paeonia lactiflora, 13-23 parts of Salvia miltiorrhiza, 7-18 parts of Ligusticum chuanxiong, 10-20 parts of Artemisia capillaris, 5-15 parts of Polygonum cuspidatum, 10-20 parts of Uncaria rhynchophylla, 10-20 parts of Lonicera japonica, 5-15 parts of Morus alba, 10-20 parts of Eclipta prostrata, 7-18 parts of Bidens pilosa, and 15-25 parts of Liquidambar formosana.

3. The external herbal dressing for improving post-interventional hematoma according to claim 1, characterized in that, The herbal dressing is composed of the following ingredients in parts by weight: 25 parts of Lycopus lucidus, 25 parts of Paeonia lactiflora, 18 parts of Salvia miltiorrhiza, 12 parts of Ligusticum chuanxiong, 15 parts of Artemisia capillaris, 10 parts of Polygonum cuspidatum, 15 parts of Uncaria rhynchophylla, 15 parts of Lonicera japonica, 10 parts of Morus alba twigs, 15 parts of Eclipta prostrata, 12 parts of Bidens pilosa, and 20 parts of Liquidambar formosana.

4. A method for preparing a topical Chinese medicine dressing for improving post-interventional hematoma as described in any one of claims 1 to 3, characterized in that, Includes the following steps: (1) Weigh each Chinese herbal raw material according to the above weight proportions, remove impurities, rinse quickly with water, dry at low temperature at 40~50℃, and pulverize into coarse powder for later use; (2) Add 8 to 10 times the amount of purified water to the crude powder of medicinal materials, soak for 30 minutes, then decoct for 1.5 hours and filter; add 6 to 8 times the amount of water to the residue and decoct for 1 hour again and filter; combine the two filtrates. (3) The filtered drug solution was concentrated at 60~70℃ and -0.06~-0.08 MPa to a paste with a relative density of 1.15~1.30; 95% ethanol was added to the paste to make the alcohol content 60%~70%, and the mixture was allowed to stand for 24 h and refrigerated to precipitate. The supernatant was then concentrated again under reduced pressure to a paste with a relative density of 1.20~1.

30. (4) Mix the extract with the medical matrix at a ratio of 1:3 to 1:5, stir evenly in a sterile environment, coat evenly on the medical non-woven fabric substrate using a coating machine, cool and shape, cut to the appropriate size, and finally sterilize to obtain the finished external Chinese medicine dressing.

5. The method for preparing a topical Chinese medicine dressing for improving post-interventional hematoma according to claim 4, characterized in that, The matrix used in step (4) is selected from one or more of the following: yellow petrolatum, carbomer, sodium alginate, and pressure-sensitive adhesive.

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