External traditional Chinese medicine composition with hemostatic and wound-healing effects and application of external traditional Chinese medicine composition

Abstract

The invention provides an external traditional Chinese medicine composition with hemostasis and wound healing effects, which relates to the field of traditional Chinese medicine compositions and comprises the following raw materials in parts by weight: 10-20 parts of bamboo shavings, 15-25 parts of rhododendron anthopogonoide, 10-20 parts of centella asiatica, 5-15 parts of lethariella cladonioides, 8-18 parts of physalis alkekengi, 10-20 parts of smoked plum, 12-22 parts of herba lycopi, 15-25 parts of sea-buckthorn, 10-20 parts of mung bean coat and 5-15 parts of asiatic toddalia root. The external traditional Chinese medicine composition can synchronously realize rapid hemostasis, heat clearing, detoxifying, blood activating, swelling subsiding, tissue regeneration promoting and sore healing.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions, and more specifically, to a topical traditional Chinese medicine composition with hemostatic and wound-healing effects and its application. Background Technology

[0002] In the field of trauma treatment, hemostasis is the first and crucial step. Currently available topical hemostatic products, such as some traditional Chinese medicine powders, although they can quickly coagulate blood, generally have two prominent problems: First, they stop bleeding but do not reduce inflammation, neglecting the prevention of wound infection and requiring the use of additional antibacterial drugs; second, strong astringent hemostasis can easily lead to bruising, that is, excessive astringency may cause poor local blood circulation, forming blood stasis, which is actually detrimental to subsequent tissue repair and growth.

[0003] On the other hand, while common topical anti-inflammatory ointments can relieve redness, swelling, heat, and pain, they are often limited in their effectiveness against active bleeding or bloody exudation, and cannot control bleeding in the first instance. Therefore, in clinical practice, multiple products are often used alternately or sequentially, which is a cumbersome process, and there may be interactions between the drugs.

[0004] Furthermore, some existing formulations either have strong odors or are irritating to broken skin, leading to poor patient compliance. Therefore, the market urgently needs a comprehensive topical formulation that can simultaneously achieve effective hemostasis, anti-inflammatory and infection prevention, and promote healing. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine external application composition with hemostatic and wound-healing effects, which can simultaneously achieve rapid hemostasis, clearing heat and detoxifying, promoting blood circulation and reducing swelling, and promoting tissue regeneration and wound healing.

[0006] Another objective of this invention is to provide an application of a traditional Chinese medicine external composition with hemostatic and wound-healing effects, which can simultaneously achieve rapid hemostasis, clearing heat and detoxifying, promoting blood circulation and reducing swelling, and promoting tissue regeneration and wound healing.

[0007] The technical problem solved by this invention is achieved by the following technical solution.

[0008] On one hand, embodiments of the present invention provide a traditional Chinese medicine external application composition with hemostatic and wound-healing effects, comprising the following raw materials by weight: Bamboo shavings 10-20 parts, Rhododendron simsii 15-25 parts, Centella asiatica 10-20 parts, Red snow tea 5-15 parts, Sophora flavescens 8-18 parts, Prunus mume 10-20 parts, Eupatorium fortunei 12-22 parts, Hippophae rhamnoides 15-25 parts, Mung bean husk 10-20 parts, and Pteris vittata 5-15 parts.

[0009] In some embodiments of the present invention, the raw materials include the following by weight: 15 parts of bamboo shavings, 20 parts of rhododendron, 15 parts of centella asiatica, 10 parts of red snow tea, 12 parts of sour plum, 15 parts of dried plum, 18 parts of eupatorium, 20 parts of sea buckthorn, 15 parts of mung bean husk, and 10 parts of dwarf palm blood.

[0010] On the other hand, embodiments of the present invention provide a traditional Chinese medicine external application composition with hemostatic and wound-healing effects, and its application in the preparation of drugs for treating traumatic bleeding, inflammatory exudative bleeding, or blood stasis bleeding.

[0011] In some embodiments of the present invention, the dosage form of the drug is a topical dosage form, including one of powder, ointment, cream, or poultice. The traditional Chinese medicine composition of the present invention can also be combined with pharmaceutical excipients to prepare various topical ointments, including ointments, creams, gels, and other dosage forms.

[0012] The ingenuity of the prescription in this invention lies in the fact that it conforms to the theoretical logic of both traditional Chinese medicine and Dai medicine, and that the two complement and reinforce each other, resulting in theoretical synergy. This in itself is an innovative design concept.

[0013] Explanation from Traditional Chinese Medicine Theory: This formula strictly follows the principles of "principal, assistant, adjuvant, and guide" and "yin-yang balance" in Traditional Chinese Medicine. The compatibility analysis based on Traditional Chinese Medicine theory is shown in Table 1.

[0014] Table 1

[0015] The core pathogenesis and treatment principles of Traditional Chinese Medicine: The core pathogenesis treated by this formula is "wind-damp-heat evil, obstruction of the meridians, qi stagnation and blood stasis". The treatment principle is "dispelling wind and dampness, clearing heat and promoting blood circulation, unblocking the meridians and relieving pain". The entire formula is rigorously structured, combining cold and warm herbs, dispersing and astringing, and attacking and tonifying, fully embodying the holistic concept and the essence of syndrome differentiation and treatment in Traditional Chinese Medicine.

[0016] The Dai medicine theory of "Four Towers and Five Aggregates" explains that human health is maintained by the dynamic balance of the "Four Towers" ("Talin"—wind, "Tanan"—water, "Tafi"—fire, and "Taling"—earth) and the "Five Aggregates" (form, consciousness, feeling, perception, and mental formations). Disease is caused by the dysfunction of the "Four Towers." Table 2 shows the compatibility analysis based on the Dai medicine theory of "Four Towers."

[0017] Table 2

[0018] Core pathogenesis and treatment principles of Dai medicine: The skin swelling, pain, and traumatic ulcers targeted by this formula are considered "co-morbidities of the four elements" in Dai medicine, which are the comprehensive manifestations of "excessive fire element, disordered wind element, imbalance of water element, and instability of earth element". The treatment principle lies in "Yata Nanlin" (balancing the four elements): clearing the fire element, smoothing the wind element, promoting the water element, and strengthening the earth element. The ingenuity of this formula lies in the synergistic effect of the ten herbs, which can simultaneously and comprehensively regulate the "four elements" and restore the internal balance of the human body.

[0019] This compatibility scheme is based on the two mature theoretical systems of "the monarch, minister, assistant, and guide" in traditional Chinese medicine and "the balance of the four elements" in Dai medicine, providing double theoretical bases and reflecting the depth and scientific nature of the invention.

[0020] Mutual verification of treatment principles: "Activating blood circulation and removing stasis" in traditional Chinese medicine is similar in effect to "smoothing the wind element" in Dai medicine.

[0021] "Clearing heat and detoxifying" in traditional Chinese medicine has the same goal as "clearing the fire element" in Dai medicine.

[0022] "Promoting diuresis and removing dampness" in traditional Chinese medicine coincides with "promoting the water element" in Dai medicine.

[0023] The concept of using Fructus Mume to "astringe and promote granulation" in traditional Chinese medicine is similar to that of promoting tissue repair by strengthening the earth element with Hippohgae rhamnoides L. and Fructus Mume in Dai medicine.

[0024] Explanation of the theory of "astringing-dispersing balance" in traditional Chinese medicine: Taking astringing to stop bleeding as the core: Fructus Mume and Oxalis corniculata L. in the formula are sour in taste and mainly function to astringe and secure, focusing on closing the wound and fixing the blood, which is the key to stopping bleeding.

[0025] Activating blood circulation and removing stasis to prevent retention: Toddalia asiatica Lam. and Eupatorium japonicum Thunb. have the dual effects of activating blood circulation and stopping bleeding. Based on astringency, they are dredged to ensure "stopping bleeding without leaving stasis" and maintain smooth local qi and blood.

[0026] Cooling blood and clearing heat to cut off the disease source: Thallus licheni, Semen Phaseoli Radiati, and Centella asiatica (L.) Urban are cool in nature and can enter the blood aspect to clear heat and cool blood. Traditional Chinese medicine says "when blood heat occurs, there will be reckless movement of blood". Clearing the heat can make the blood stable, reducing the bleeding tendency from the root.

[0027] Synergy of the whole formula: The whole formula has a rigorous structure, with "astringing" (Fructus Mume and Oxalis corniculata L.) and "activating blood circulation" (Toddalia asiatica Lam. and Eupatorium japonicum Thunb.) as the main treatment lines of unity of opposites, assisted by "clearing heat" (Thallus licheni, etc.) and "promoting granulation" (Hippohgae rhamnoides L., etc.), jointly achieving the effects of regulating qi and blood and repairing the wound surface.

[0028] Explanation of the theory of "balance of the four elements" in Dai medicine: The bleeding, swelling, and pain treated by this formula are regarded as "co-morbidities of the four elements" in Dai medicine.

[0029] Clearing "Taffy" (Fire Tower): Bleeding and inflammation are both signs of "excessive fire tower". Red snow tea, centella asiatica, etc. can effectively clear excessive fire and calm abnormal blood heat.

[0030] The concept of "wind tower disorder" refers to pain and spasms. The blood-activating properties of Rhododendron simsii and Pterocarya stenoptera can dispel wind, unblock the meridians, regulate the wind tower, and relieve pain.

[0031] "Water tower" refers to tissue edema and exudation, which is considered "water tower disorder." Centella asiatica and Eupatorium fortunei can promote diuresis, reduce swelling, and regulate fluid metabolism.

[0032] Strengthening the "Solid Foundation": Tissue damage and slow repair are considered "unstable foundations." Ume plums and sea buckthorn can enhance the body's ability to consolidate and regenerate, much like fertile soil nurturing tissue, promoting wound healing.

[0033] The topical ointment of this invention, based on its unique therapeutic properties of "stopping bleeding without leaving blood stasis, reducing inflammation and promoting tissue regeneration," exhibits broad clinical applicability, and is particularly suitable for (but not limited to) the following disease spectrum and clinical symptoms: With broad therapeutic targets and the advantage of multi-pathway synergistic therapy, this formula does not target a single pathogenesis or symptom. Instead, it is based on the principles of "treating different diseases with the same method" in traditional Chinese medicine and "harmonizing the four elements" in Dai medicine. Through the synergistic effects of multiple pharmacological actions such as clearing heat and detoxifying, promoting blood circulation and removing blood stasis, dispelling wind and dampness, and astringing and promoting tissue regeneration, it simultaneously intervenes in multiple pathological processes such as inflammation, pain, swelling, and tissue damage. Compared with commercially available ointments with single effects (such as only analgesia or only anti-inflammation), this invention achieves a comprehensive "four-in-one" therapeutic effect of anti-inflammation, analgesia, swelling reduction, and repair.

[0034] The disease coverage is comprehensive and applicable to various types of traumatic surgical swelling and pain. The Chinese medicine composition of this invention has shown significant efficacy in the following three major disease spectrums, demonstrating its potential as a "general surgical formula": (1) Acute traumatic swelling and pain: can quickly relieve pain, reduce hematoma, and promote tissue repair. (2) Inflammatory swelling and pain: can effectively inhibit inflammatory response and reduce symptoms of redness, swelling, heat, and pain. (3) Chronic and difficult-to-heal skin damage: promotes wound and sore healing by improving local microcirculation and providing nutrition.

[0035] It has a rapid onset and long-lasting effect, fundamentally improving symptoms. The principal herbs in the formula (fragrant azalea and dragon's blood) are potent and can quickly penetrate the skin to target the lesion, achieving rapid pain relief. At the same time, the assistant and adjuvant herbs work synergistically to regulate the local balance of the four elements (wind, fire, water, and earth) or the balance of Qi, blood, Yin, and Yang, eliminating pathogenic factors. It not only treats the symptoms but also focuses on strengthening the body's foundation and repairing the body, effectively reducing the recurrence rate.

[0036] It boasts extremely high safety and excellent patient compliance. The entire formula utilizes pure natural medicinal herbs, employing a rigorous "combination of warming and cooling" approach to effectively neutralize the imbalances of any single drug. It is non-irritating and non-allergenic to the skin. The product is odorless, has an acceptable color, and offers high comfort during use, without staining clothing, greatly enhancing patient adherence. It is especially suitable for long-term or large-area use.

[0037] The topical ointment of this invention is particularly suitable for (but not limited to) the following diseases or symptoms: Acute traumatic bleeding and swelling manifest as: oozing from skin abrasions; active bleeding from cuts and punctures; and subcutaneous soft tissue hematoma, bruising, and swelling caused by falls, contusions, and crushing injuries. The formula contains *Pteris vittata*, *Prunus mume*, and *Physalis alkekengi*, which rapidly constrict blood vessels and promote coagulation; *Eupatorium fortunei* and *Rhododendron simsii* simultaneously invigorate blood circulation, dispel blood stasis, prevent hematoma solidification, and relieve pain.

[0038] This formula is suitable for open surface wounds and postoperative incisions, specifically including: healing care of various surgical incisions (such as thyroid surgery and cesarean section); superficial second-degree burns; and traumatic skin defects. The formula contains dried plum and sea buckthorn, which promote tissue regeneration and granulation tissue growth and epithelial creep; and red snow tea and mung bean husks, which clear heat and detoxify, effectively preventing wound infection and providing a clean environment for repair.

[0039] Infectious and inflammatory diseases of the skin and subcutaneous tissues, specifically manifested as: the red, swollen, hot, and painful stages of folliculitis, boils, carbuncles, erysipelas, etc.; the early stage of subcutaneous cellulitis; and the erosive surface after rupture of herpes zoster. In the formula, red snow tea, centella asiatica, and sorrel powerfully clear away "fire towers" and inhibit inflammatory responses; strong rhododendron dispels wind and relieves pain, alleviating the accompanying severe pain.

[0040] Inflammatory and degenerative pain of the musculoskeletal system, specifically manifested as: acute attacks of joint swelling and pain in rheumatoid arthritis and osteoarthritis; frozen shoulder, tendinitis (such as tennis elbow and golfer's elbow), and bursitis. In this formula, *Pterocarya stenoptera* and *Eupatorium fortunei* invigorate blood circulation and clear the meridians, improving local circulation and eliminating inflammatory effusion; *Rhododendron simsii* has strong penetrating power, reaching deep into the muscles and bones to dispel wind and dampness and relieve pain.

[0041] Blood circulation disorders and related complications, specifically manifested as: leg swelling and pain, pigmentation, and even ulcers (chronic leg ulcers) caused by varicose veins in the lower extremities; cord-like induration and pain caused by thrombophlebitis; and pressure-induced swelling due to prolonged bed rest. This formula effectively improves venous return, reduces tissue edema and blood stasis, and provides conditions for the repair of refractory ulcers by combining blood-activating (Pteris vittata, Lycopus lucidus, Hippophae rhamnoides) and diuretic (Centella asiatica, Bambusa textilis).

[0042] Chronic, refractory skin ulcers and wounds, specifically manifested as: early diabetic foot ulcers; pressure injuries (bedsores); radiation-induced skin injuries. This formula concentrates on the "soil-strengthening" and "tissue-regenerating" functions. Sea buckthorn and dried plum provide rich nutritional support and astringe wounds; centella asiatica stimulates fibroblast activity, jointly promoting tissue regeneration and epithelialization.

[0043] Compared with the prior art, the embodiments of the present invention have at least the following advantages or beneficial effects: It pioneered a "balanced astringency and dispersibility" hemostasis mechanism: through the precise combination of astringent and blood-activating drugs, it achieves rapid hemostasis while effectively preventing blood stasis, creating a clean and unobstructed microenvironment for wound repair, which is unmatched by a single hemostatic drug.

[0044] Multiple effects activated simultaneously: This formula breaks away from the traditional linear treatment model of "stopping bleeding first and then reducing inflammation" or "reducing inflammation first and then promoting tissue regeneration". It can simultaneously trigger the repair process of three key pathological links, namely hemostasis, anti-inflammation and tissue regeneration, after external application, which greatly improves the treatment efficiency.

[0045] Profound and unique theoretical support: This formulation is the product of a deep integration of the traditional Chinese medicine theory of "principal, assistant, adjuvant and guide" and the Dai medicine theory of "four-tower balance". Its design concept is original and is not a simple superposition of technologies in this field. It provides a cross-medical system theory for the excellent efficacy of this composition.

[0046] It has a wide range of indications and high safety: it is effective for bleeding and swelling caused by a variety of reasons, from acute trauma to chronic ulcers. All ingredients are natural medicinal materials, and the combination of cold and warm herbs makes it gentle and non-irritating to the skin with excellent biocompatibility. Detailed Implementation

[0047] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0048] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other. The present invention will now be described in detail with reference to specific embodiments.

[0049] The features and performance of the present invention will be further described in detail below with reference to embodiments.

[0050] Example 1 Prepare the ingredients according to the following proportions: 15 parts of bamboo shavings, 20 parts of rhododendron, 15 parts of centella asiatica, 10 parts of red snow tea, 12 parts of sour plum, 15 parts of dried plum, 18 parts of eupatorium, 20 parts of sea buckthorn, 15 parts of mung bean husk, and 10 parts of dwarf palm blood.

[0051] Prepare the topical medication by following these steps: All medicinal materials should be qualified processed slices that meet the requirements of the Chinese Pharmacopoeia or local processing standards, and non-medicinal parts and impurities should be removed.

[0052] Rhododendron simsii and Pterocarya stenoptera are coarsely pulverized using a grinder and then passed through a 20-mesh sieve for later use.

[0053] 1. Percolation Extraction: Mix the crushed Rhododendron simsii with coarsely powdered Pterocarya stenoptera. Moisten with an appropriate amount of 70% ethanol, pack into a percolation tube, press tightly, and soak for 24 hours. Percolate at a flow rate of 2 mL / min / kg of herb, collecting approximately 8-10 times the volume of the herb as percolate. Recover the ethanol from the collected percolate using a vacuum distillation apparatus (rotary evaporator) at temperatures below 60℃ to obtain an ethanol extract for later use.

[0054] 2. Water Extraction: Combine bamboo shavings, centella asiatica, red snow tea, sorrel, dried plum, eupatorium, sea buckthorn, and mung bean husk. For the first decoction, add 10 times the total weight of the herbs in water, soak for 30 minutes, heat to a boil, then simmer for 1 hour. Filter and collect the filtrate. For the second decoction, add 8 times the amount of purified water to the residue and decoct for 1 hour. Filter again. Combine the two filtrates and filter through a 200-mesh sieve to remove fine residue. Transfer the filtrate to a vacuum concentration tank and concentrate to a thick paste with a relative density of approximately 1.10-1.15 (measured at 60℃) to obtain the water extract for later use.

[0055] 3. Mixing the drug with the matrix Oil phase: Take 65g stearic acid, 13g monoglyceride, 13g lanolin, 52g white petrolatum, and 20g vegetable oil, heat them in a water bath to 75-80℃ until they are completely melted, and keep them at that temperature.

[0056] Aqueous phase: 98g glycerin, 10g honeysuckle hydrosol, 380g purified water, mix and heat to 75-80℃.

[0057] While stirring continuously, slowly pour the aqueous phase into the oil phase, stirring in the same direction until emulsification is complete, forming a uniform, fine, milky white matrix paste. Stop heating and continue stirring to cool.

[0058] When the matrix temperature drops to 50-60℃, the ethanol extract and water extract prepared in the above steps are added in sequence, wherein the total mass of the ethanol extract and water extract is 40% of the total mass of the ointment.

[0059] Continue stirring until the paste cools to room temperature and becomes uniform, fine, and smooth. Transfer the paste to a sealed container and leave it at room temperature for 24 hours to obtain the ointment of this embodiment.

[0060] Experimental Example 1. Experimental Design and Methods Study design: multicenter, randomized, double-blind, positive-drug parallel-controlled study.

[0061] Randomization and Blinding: A central randomization system was used to allocate subjects to the experimental and control groups in a 1:1 ratio. The random sequence was generated independently by statistical methods, and the medication was coded and dispensed by pharmacists who were not involved in the efficacy evaluation, ensuring blinding among subjects, researchers, and efficacy evaluators.

[0062] Subjects and Intervention: A total of 240 subjects with acute soft tissue injury who met the criteria were included.

[0063] Experimental group (n=120): Topical application of the ointment of Example 1 of the present invention.

[0064] Control group (n=120): External application of commercially available mainstream Chinese herbal anti-inflammatory and analgesic plaster (safflower oil).

[0065] Treatment method: Both groups applied the medication externally twice daily for 14 days.

[0066] Primary endpoint: Change in VAS pain score from baseline on day 7 of treatment.

[0067] Secondary endpoints: swelling reduction rate, ecchymosis area reduction rate, overall efficacy and safety on day 14.

[0068] Subject selection criteria (using internationally recognized standards); diagnostic criteria: referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and the diagnostic criteria for acute soft tissue injury in "Surgery".

[0069] Inclusion criteria: age 18-65 years, injury time ≤48 hours; local VAS pain score ≥4; wound area 5-30cm², with obvious swelling and / or ecchymosis.

[0070] Exclusion criteria: presence of fracture, dislocation, or infected skin lesions; coexisting severe systemic diseases; allergy to any component of the investigational drug.

[0071] 2. Efficacy evaluation indicators and statistical methods Evaluation indicators: Pain: 100mm visual analog scale (VAS), recorded by an uninformed third-party assessor.

[0072] Swelling degree: Volume is quantified using laser 3D scanning technology with an accuracy of up to 0.1cm. 3.

[0073] Ecchymosis area: Pixel-level precise calculation was performed using digital photography and ImageJ image analysis software.

[0074] Overall therapeutic effect: Based on the guiding principles, it is divided into clinical control, significant effect, effective and ineffective.

[0075] Statistical methods: Intention-to-treat (ITT) analysis and proportionate proposal (PP) analysis were used together. Quantitative data are expressed as mean ± standard deviation (x ± s). Independent samples t-tests were used for comparisons between groups, and chi-square tests were used for categorical variables. SPSS 25.0 software was used, and p < 0.05 was considered statistically significant.

[0076] 3. Test Results Table 3: Baseline characteristics of subjects (ITT set, x ± s)

[0077] Table 3 shows that the two sets of baseline data are comparable (P>0.05).

[0078] Table 4: Changes in primary and secondary efficacy endpoints (x ± s, ITT set)

[0079] Note: Within-group comparison (vs baseline), **P<0.01; Between-group comparison at the same time, ##P<0.01.

[0080] Table 5: Comparison of overall therapeutic effects on day 14 post-treatment (ITT set) [n(%)]

[0081] Note: The difference in the overall effective rate between the two groups was statistically significant according to the χ² test (χ²=4.32, P=0.038).

[0082] Based on the above inclusion criteria, the following typical cases were selected.

[0083] Case 1: Acute ankle sprain (sports injury) Mr. Zhang, a 28-year-old male, presented with a right ankle inversion sprain sustained 2 hours prior during basketball. Physical examination revealed ++ swelling on the lateral side of the right ankle, ecchymosis (3cm × 4cm), VAS score of 7, and limited range of motion. Treatment: Topical application of the ointment of this invention, three times daily. Results: Swelling subsided by 50% within 24 hours, and the VAS score decreased to 4. The ecchymosis was largely absorbed within 72 hours, and the VAS score decreased to 2, allowing for normal walking. The principal ingredient, *Pterocarya styracifolia*, synergistically with *Rhododendron simsii*, rapidly inhibits the release of substance P locally, reducing the levels of inflammatory mediators (TNF-α, IL-6), thus achieving rapid analgesia.

[0084] Case 2: Diabetic foot ulcer (chronic, non-healing wound) Ms. Wang, 65 years old, female, with a 10-year history of type 2 diabetes, presented with a left plantar ulcer that had not healed for 4 weeks. Physical examination: The ulcer area was 2.5cm × 2.0cm, with a pale base and a small amount of exudate. Treatment: After debridement, the ointment of this invention was applied topically twice daily. Results: On day 7, the exudate from the wound decreased, and granulation tissue began to grow. On day 21, the ulcer area shrank by 80%, and epithelial creep was obvious. This is supported by Dai medicine theory: The synergistic effect of dried plum and sea buckthorn in "stabilizing the soil" promotes fibroblast proliferation and collagen remodeling.

[0085] Case 3: Superficial second-degree burns Mr. Li, 35 years old, male, suffered a hot oil burn on his right forearm 12 hours prior. Physical examination: The wound was red and swollen, measuring 4cm × 5cm, with vesicles formed; VAS score was 6. Treatment: After aseptic vesicle aspiration, the ointment of this invention was applied topically. Results: On day 3, the redness and swelling significantly subsided, and the VAS score decreased to 2. On day 10, the wound was completely epithelialized, with no pigmentation. Centella asiatica extract accelerates epithelial regeneration by regulating the TGF-β / Smad pathway.

[0086] Case 4: Poor postoperative wound healing Ms. Zhao, 52 years old, presented with abdominal wall incision bleeding and swelling following laparoscopic surgery. Physical examination revealed peri-incision redness and swelling (2cm x 3cm) with a small amount of bloody oozing. Treatment: Topical application of the ointment of this invention twice daily. Result: Bleeding ceased within 48 hours, and redness and swelling subsided. The incision healed primarily on the 5th day, and sutures were removed. Key features: Hemostasis without bruising; the dual regulation of astringent properties of dried plum and blood-activating properties of eupatorium fortunei prevents hematoma formation.

[0087] Case 5: Varicose dermatitis with ulcers Mr. Sun, 70 years old, male, had varicose veins in both lower extremities for 30 years and an ulcer on his left medial malleolus for 2 months. Physical examination: ulcer 3cm × 3cm, surrounding skin pigmentation, lower extremity edema (++). Treatment: Elevation of the affected limb, topical application of the ointment of this invention. Result: On day 14, the ulcer area shrank by 60%, and the lower extremity edema subsided. On day 35, the ulcer completely healed. The synergistic effect of the four towers: Centella asiatica benefits the "water tower" to reduce edema, while Hippophae rhamnoides strengthens the "soil tower" to promote healing.

[0088] Case 6: Postherpetic neuralgia Ms. Zhou, 58 years old, presented with persistent pain in the postherpetic neuralgia area of ​​her chest and back for one month. Physical examination revealed that the lesions had subsided, but significant local tenderness remained, with a VAS score of 5. Treatment: Topical application of the ointment of this invention, three times daily. Results: By day 7, tenderness had decreased, and the VAS score had dropped to 3. By day 21, the pain had essentially disappeared, and the VAS score was 1. Analgesic mechanism: The volatile oil components of Rhododendron simsii penetrate the skin barrier and inhibit the release of substance P from the dorsal root ganglion.

[0089] Case 7: Swelling following distal radius fracture Ms. Chen, 45 years old, presented with hand swelling for 3 days after plaster cast immobilization for a Colles' fracture. Physical examination revealed hand swelling (+++), slightly elevated skin temperature, and a VAS score of 6. Treatment: Topical application of the ointment of this invention to the swollen area three times daily. Results: Swelling decreased by 40% within 24 hours, and the VAS score dropped to 3. By day 5, the swelling had largely subsided, and finger movement was restored. Mechanism of action: The combination of *Eupatorium fortunei* and *Centella asiatica* promotes interstitial fluid return and accelerates edema absorption.

[0090] Case 8: Chemotherapy-induced phlebitis Ms. Liu, 50 years old, female, developed phlebitis in her left forearm after chemotherapy following breast cancer surgery. Physical examination: Cord-like induration along the vein, redness, swelling, and pain; VAS score: 5. Treatment: Topical application of the ointment of this invention, 4 times daily. Results: On the 3rd day, the redness and swelling subsided, and the induration softened. On the 10th day, the venous cords had largely disappeared; VAS score: 1. Demonstration of blood circulation and meridian unblocking: The "Flying Dragon Palm" ointment improves local microcirculation and promotes the absorption of inflammation.

[0091] Case 9: Eczema with infection from scratching Yang, a 6-year-old male, presented with secondary infection following scratching of eczema on both lower limbs. Physical examination revealed multiple scratch marks, some with crusting, and surrounding redness and swelling. Treatment: Topical application of the ointment of this invention, twice daily. Results: Redness and swelling subsided on the second day, and exudation decreased. On the seventh day, the crusts fell off, revealing intact new skin. Safety verification: The child's skin tolerated the treatment well, with no irritation or allergic reactions, demonstrating the safety of the formula.

[0092] Through in-depth analysis of the above nine typical cases, we can conclude that: Cases 1, 3, and 7 show that the topical ointment of Example 1 of the present invention can significantly improve acute symptoms within 24 hours, which may be related to the fact that the volatile components of Rhododendron simsii can quickly penetrate the skin barrier and bind to local pain receptors.

[0093] Cases 2, 4, and 5 demonstrate that the present invention can quickly stop bleeding without causing excessive dryness of the wound. It achieves a balance between astringency and dispersion, and the formula can create a moist and balanced microenvironment on the wound surface, which inhibits bacterial growth and promotes cell migration.

[0094] The significant therapeutic effect in Case 6 suggests that the present invention may contain specific components that act on the nervous system. Further basic research confirmed that coumarin components in the blood of *Palmeria nivea* can inhibit the expression of pain-related genes in the dorsal root ganglion.

[0095] Cases 5 and 8 demonstrate that this invention not only acts on the body surface but also improves the function of deep blood vessels. Ultrasound examination showed that after use, blood flow to the affected area increased by 35% and vascular permeability decreased by 28%, providing a new approach for the treatment of vascular-related diseases.

[0096] The analysis of the above experimental data and therapeutic effects shows that the modern pharmacological mechanism upon which the formulation of this invention is based is highly consistent: Rapid analgesia and swelling reduction: This is directly related to the pharmacological effects of the principal drug, Rhododendron simsii (rich in flavonoids, with clear anti-inflammatory and analgesic effects), and Pteris vittata (containing coumarin components that can inhibit the release of inflammatory factors such as TNF-α and IL-6). Trial data showed that in the early stage of treatment (day 3), the VAS score and swelling degree in the experimental group were significantly lower than those in the control group (P<0.01), confirming the strong initiating effect of the principal drug.

[0097] Highly effective in dispersing blood stasis and stopping bleeding: The synergistic effect of the principal herb Lycopus lucidus (which promotes blood circulation and removes blood stasis) and the adjuvant herbs Prunus mume and Ophiopogon japonicus (which have astringent and hemostatic properties) achieves the effect of stopping bleeding without leaving blood stasis. As a result, the area of ​​ecchymosis in the experimental group decreased significantly faster than that in the control group, and no cases of hematoma sclerosis or recurrence were observed.

[0098] Promoting tissue repair: The synergistic effect of Centella asiatica (whose main active ingredient, asiaticoside, can promote fibroblast proliferation and collagen synthesis by upregulating TGF-β1 expression) and Hippophae rhamnoides (rich in vitamins and antioxidants) provides a microscopic material basis for wound repair, corresponding to the higher clinical control rate and wound healing rate in the experimental group.

[0099] From a molecular biology perspective, the multiple benefits of this invention can be explained through the following pathways: Analgesic pathway: Rhododendron flavonoids → TRPV1 receptor → inhibit calcium ion influx → reduce substance P release; Anti-inflammatory pathway: Pterocarya scabra coumarin → NF-κB pathway → downregulates TNF-α and IL-6 expression; Healing pathway: Centella asiatica extract → TGF-β1 / Smad3 → promotes collagen synthesis and epithelial regeneration; Hemostatic pathway: Prunus mume organic acids → activate coagulation factor XII → accelerate fibrinogen conversion; During the trial, the incidence of adverse events in the experimental group and the control group was 1.7% (2 / 120) and 2.5% (3 / 120), respectively. All were mild, transient local skin reactions that resolved spontaneously without treatment and were considered to be possibly related to the investigational drug. No clinically significant abnormalities were found in vital signs or laboratory tests in either group.

[0100] In summary, the herbal composition of this invention achieves a perfect integration of traditional Chinese medicine theory and modern molecular pharmacology. In the treatment of acute soft tissue injuries, it significantly outperforms mainstream commercially available control products in terms of rapid analgesia, efficient swelling reduction, promotion of ecchymosis absorption, and overall efficacy, while exhibiting good safety. Its therapeutic advantages are supported by modern pharmacological mechanisms, reflecting a deep integration of traditional Chinese medicine compatibility theory and modern scientific practice. Nine typical cases not only verified the reliability and broad applicability of its clinical efficacy but also revealed its multi-target and multi-level action characteristics. This efficacy of both stopping bleeding and promoting blood circulation, as well as reducing inflammation and promoting tissue regeneration, stems from the synergistic effect of the various medicinal components in the body, constituting the irreplaceable core value of this invention.

[0101] The embodiments described above are some, but not all, embodiments of the present invention. The detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine external application composition with hemostatic and wound-healing effects, characterized in that, By weight, it includes the following ingredients: Bamboo shavings 10-20 parts, Rhododendron simsii 15-25 parts, Centella asiatica 10-20 parts, Red snow tea 5-15 parts, Sophora flavescens 8-18 parts, Prunus mume 10-20 parts, Eupatorium fortunei 12-22 parts, Hippophae rhamnoides 15-25 parts, Mung bean husk 10-20 parts, and Pteris vittata 5-15 parts.

2. The topical Chinese medicine composition with hemostatic and wound-healing effects according to claim 1, characterized in that, By weight, it includes the following ingredients: 15 parts of bamboo shavings, 20 parts of rhododendron, 15 parts of centella asiatica, 10 parts of red snow tea, 12 parts of sour plum, 15 parts of dried plum, 18 parts of eupatorium, 20 parts of sea buckthorn, 15 parts of mung bean husk, and 10 parts of dwarf palm blood.

3. The application of a traditional Chinese medicine external application composition with hemostatic and wound-healing effects as described in claim 1 or 2 in the preparation of drugs for treating traumatic bleeding, inflammatory exudative bleeding, or blood stasis bleeding.

4. The application according to claim 3, characterized in that, The drug is in the form of a topical medication, including one of the following: powder, ointment, cream, or poultice.

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