Multifunctional external traditional Chinese medicine composition for promoting blood circulation and removing blood stasis and preparation process and application thereof

Abstract

This invention discloses a multifunctional topical Chinese medicine composition for promoting blood circulation and removing blood stasis, along with its preparation process and application, belonging to the field of topical Chinese medicine preparation technology. The composition consists of 49 raw materials, including 3 parts of *Panax japonicus*, 3 parts of *Spatholobus suberectus*, and 3 parts of *Poria cocos*. Through pretreatment of the medicinal materials, compound extraction (water extraction, alcohol extraction, and volatile oil extraction), and formulation processes, it can be prepared into a purified spray, a boiled ointment, or a wine-soaked preparation. This invention overcomes the limitation of traditional topical Chinese medicines having only one indication, and can be used simultaneously for traumatic injuries, chronic musculoskeletal strain, scalds, and insect bites. Traumatic injuries heal in 3-5 days, scalds prevent blistering after application, and insect bites stop itching within 2-3 minutes. The efficacy is significant and the safety is high. The three preparation processes are simple to operate, suitable for different scenarios, and have extremely high clinical application and promotion value.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine external preparation technology, and specifically relates to a multifunctional blood-activating and stasis-removing external traditional Chinese medicine composition, its preparation process and application. Background Technology

[0002] In the traditional Chinese medicine system, external application of Chinese herbal medicines has always been an important means of treating injuries, rheumatic pain, and other ailments due to its characteristics of "directly reaching the affected area, rapid onset of action, and minimal side effects." From the theoretical foundation laid by the ancient text *Li Yue Pian Wen* that "the principles of external treatment are the same as those of internal treatment," to the development of modern transdermal drug delivery technology (TDDS), the research and development of external Chinese herbal medicines has always revolved around three core aspects: "authenticity of medicinal materials, rationality of formulation, and suitability of processing." However, existing external Chinese herbal medicine products still have many unresolved pain points, which seriously limit their clinical application and patient experience.

[0003] First, the problem of limited indications is prominent. Currently, most commercially available topical Chinese medicine preparations are designed for single symptoms. For example, Yunnan Baiyao aerosol mainly targets sprains and bruises, burn ointment is only suitable for scalds, and mosquito repellent only relieves itching from mosquito bites. This "one disease, one medicine" model requires patients to keep multiple medications on hand, increasing medication costs and management difficulties. Especially for the common combined needs of middle-aged and elderly people, such as "neck, shoulder, back and leg pain + occasional sprains and bruises + summer insect bites," existing products cannot achieve "one medicine for multiple uses," resulting in poor clinical compliance.

[0004] Secondly, the speed of onset of action and the duration of treatment are difficult to balance. For acute sprains and strains, existing products often require continuous use for 7-10 days to see results; while for chronic musculoskeletal injuries (such as cervical and lumbar degeneration), although some products claim "effectiveness after a course of treatment," in reality, continuous use for more than one month is required, and relapse is common after discontinuation. In addition, for acute conditions such as burns, traditional Chinese medicine preparations (such as purple gromwell oil) can prevent infection, but cannot quickly stop the formation of blisters, requiring patients to undergo Western medical debridement, which increases pain.

[0005] Third, their applicability to specific scenarios is insufficient. For example, unbearable itching after mosquito bites is a common summer problem, but existing anti-itch products (such as medicated oil and floral water) often contain alcohol or camphor, which are highly irritating to broken skin; while traditional Chinese medicine anti-itch preparations (such as peony bark ointment) typically take effect in 5-10 minutes, failing to meet the need for "immediate itch relief." Similarly, if scalds are not treated promptly, the formation of blisters will prolong the healing process, but existing traditional Chinese medicine burn ointments often need to be applied after rinsing with cold water, failing to halt the pathological process before blisters form.

[0006] More importantly, existing technologies have limitations in their formulation of medicinal herbs. Most external blood-activating and stasis-removing formulas are based on modified versions of traditional formulas like "Taohong Siwu Tang" and "Xuefu Zhuyu Tang," with core herbs concentrated in traditional blood-activating herbs such as Angelica sinensis, Carthamus tinctorius, and Ligusticum chuanxiong. They lack a systematic integration of herbs that address "wind-dampness, heat-clearing and detoxifying, and pain-relieving" properties. For example, existing formulas often fail to address the complex pathogenesis of "bruising and rheumatism" after traumatic injuries (common in middle-aged and elderly manual laborers) due to the lack of wind-dispelling herbs like Notopterygium incisum and Angelica pubescens. Similarly, for "heat toxicity stagnation" after burns, the lack of heat-clearing and detoxifying herbs like Lonicera japonica and Forsythia suspensa hinders rapid anti-inflammatory effects. Furthermore, for "wind-evil causing itching" after insect bites, the lack of wind-dispelling and antipruritic herbs like Clematis chinensis and Mentha haplocalyx results in slow efficacy. This one-sidedness in formulation directly leads to limited product functionality, failing to meet the needs of multiple scenarios.

[0007] Furthermore, the crudeness of the preparation process also restricts the efficacy of the medicine. Traditional external Chinese medicines often use the "water decoction concentration" or "white wine soaking" process. The former easily leads to the loss of volatile oil components (such as menthol and ligustrazine), while the latter affects the dissolution of fat-soluble components due to the uncontrollable ethanol concentration. For example, if toxic herbs such as aconite and black vine are soaked in ordinary wine, the risk of skin irritation may increase due to excessive dissolution of aconitine-like components; while if precious herbs such as trifoliate orange and American ginseng are only decocted with water, the active ingredients such as polysaccharides and saponins cannot be fully extracted, resulting in resource waste. Summary of the Invention

[0008] In view of this, the present invention provides a multifunctional external application Chinese medicine composition for promoting blood circulation and removing blood stasis, as well as its preparation process and application, to solve or alleviate one of the technical problems existing in the prior art, and at least provide a beneficial option.

[0009] The technical solution of this invention is implemented as follows: A multifunctional external Chinese medicine composition for promoting blood circulation and removing blood stasis, composed of the following raw materials in parts by weight: 3 parts of Codonopsis pilosula, 3 parts of Spatholobus suberectus, 3 parts of Poria cocos, 3 parts of Rosa laevigata, 2 parts of Notopterygium incisum, 1 part of Rhizoma Scutellariae Radix, 2 parts of Paeoniae Radix Alba, 2 parts of Carthami Flos, 3 parts of Lonicerae Flos, 2 parts of Herba Scutellariae, 3 parts of Herba Senecio scandens, 3 parts of Radix Angelicae Sinensis, 1 part of Herba Artemisiae Laevigatae, 3 parts of Radix Salviae Miltiorrhizae, 3 parts of Radix Liquidambare, 2 parts of Radix Curcumae, 3 parts of Radix Cinnamomi, 2 parts of Rhizoma Drynariae, 2 parts of Radix Paeoniae Rubra, 1 part of Radix Saposhnikoviae, 1 part of Rhizoma Ligustici Chuanxiong, 2 parts of Fructus Gardeniae, 2 parts of Radix Polygoni Multiflori, 2 parts of Cortex Albiziae, 2 parts of Radix Gynostemmae, 3 parts of Radix Zingiberis, 2 parts of Radix Paeoniae Rubra, and 2 parts of Radix Gynostemmae. 1 part of Aconitum carmichaelii, 1 part of Erythrina variegata bark, 2 parts of Atractylodes macrocephala, 2 parts of Boswellia carterii, 3 parts of Gentiana macrophylla, 3 parts of Ophiopogon japonicus, 12 parts of Commiphora myrrha, 1 part of Trifolium repens, 2 parts of Cimicifuga foetida, 2-3 parts of Panax notoginseng, 2 parts of Trifolium repens, 2 parts of Forsythia suspensa, 1-2 parts of Panax quinquefolius, 1 part of Selaginella tamariscina, 2 parts of Clematis chinensis, 2 parts of Mentha haplocalyx, 2 parts of Angelica pubescens, 1 part of Rhodiola rosea root, 1 part of Crataegus pinnatifida root, 3 parts of Acer palmatum, 1 part of Scutellaria baicalensis root; the preparation process of the composition includes the steps of medicinal material pretreatment, compound extraction and formulation forming, wherein the compound extraction includes water extraction, alcohol extraction and volatile oil extraction, and the formulation forming can be prepared into a purified dosage form, a water decoction dosage form or a wine soaking dosage form according to the requirements.

[0010] Furthermore, in the pretreatment steps of the medicinal materials: *Aconitum carmichaelii* and *Ipomoea purpurea* are individually sorted to remove moldy individuals; *Mentha haplocalyx* and *Clematis chinensis* are air-dried until the moisture content is ≤10%; the remaining medicinal materials are naturally sun-dried until the moisture content is ≤12%. The water extraction process specifically involves: soaking 40 medicinal materials (excluding frankincense, myrrh, and mint) in 8 times the volume of purified water for 60 minutes, then decocting at 100℃ for 2 hours and filtering. The residue is then decocted again in 6 times the volume of purified water for 1.5 hours and filtered. The two filtrates are combined and concentrated under reduced pressure to a relative density of 1. 0.15-1.20 (measured at 60℃); The alcohol extraction process is as follows: Frankincense and myrrh are pulverized and passed through a 20-mesh sieve, then soaked in 6 times the amount of 70% ethanol at room temperature for 24 hours and filtered. The residue is then refluxed with 4 times the amount of 70% ethanol for 1 hour and filtered. The filtrates are combined and the ethanol is recovered until there is no alcohol odor. The volatile oil extraction process is as follows: Peppermint, Clematis armandii, Ligusticum chuanxiong, and Angelica sinensis are extracted with 5 times the amount of water using steam distillation for 4 hours. The volatile oil layer is collected, and the distilled water solution is combined with the concentrated water extract.

[0011] Furthermore, the preparation method of the purified formulation is as follows: after mixing the water extract concentrate, alcohol extract and distilled water solution, add volatile oil and 0.3% of ethylparaben, stir to dissolve, and adjust the total amount with purified water to 5 times the total weight of the medicinal materials, and fill into a spray. This formulation is suitable for first aid use for scalds and insect bites. It can relieve itching in 2-3 minutes after spraying, and prevents the formation of blisters after use for scalds.

[0012] Furthermore, the preparation method of the boil-in-water formulation is as follows: after mixing the water extract concentrate, alcohol extract and distilled water solution, the mixture is directly concentrated to a relative density of 1.30-1.35 (measured at 60℃) without adding preservatives, and then packaged after cooling to obtain the ointment; this formulation is suitable for topical application of bruises and sprains, and can be used 2-3 times a day for 3-5 consecutive days to achieve a cure.

[0013] Furthermore, the preparation method of the alcohol-infused dosage form is as follows: all 49 cleaned medicinal materials are pulverized and passed through a 40-mesh sieve, soaked in 45% vol rice wine at room temperature for 30 days, stirred once a day, and filtered to remove residue. This dosage form is suitable for massage use for chronic musculoskeletal strains such as cervical spondylosis, lumbar spondylosis, and knee pain, and needs to be used continuously according to the course of treatment to improve symptoms.

[0014] Furthermore, the weight proportions of the raw materials are as follows: 3 parts of Codonopsis pilosula, 3 parts of Spatholobus suberectus, 3 parts of Poria cocos, 3 parts of Rosa laevigata, 2 parts of Notopterygium incisum, 1 part of Rhizoma Scutellariae Radix, 2 parts of Paeoniae Radix Alba, 2 parts of Carthami Flos, 3 parts of Lonicerae Flos, 2 parts of Herba Scutellariae, 3 parts of Senecio scandens, 2 parts of Angelica sinensis, 1 part of Rhizoma Scutellariae Radix, 3 parts of Radix Salviae Miltiorrhizae, 3 parts of Rhizoma Liquidambare, 2 parts of Radix Curcumae, 3 parts of Radix Cinnamomi, 2 parts of Rhizoma Drynariae, 2 parts of Radix Paeoniae Rubra, 1 part of Radix Saposhnikoviae, 1 part of Rhizoma Ligustici Chuanxiong, 2 parts of Fructus Gardeniae, 2 parts of Radix Polygoni Multiflori, 2 parts of Cortex Albiziae, 2 parts of Radix Gynostemmae, 3 parts of Radix Zingiberis, and 2 parts of Radix Paeoniae Rubra. The following ingredients are listed: 1 part black vine, 1 part aconite, 2 parts Erythrina bark, 2 parts Atractylodes macrocephala, 2 parts frankincense, 3 parts Gentiana macrophylla, 3 parts Ophiopogon japonicus, 12 parts myrrh, 1 part three-leaf clover, 2 parts Cimicifuga foetida, 3 parts Panax notoginseng, 2 parts bitter twig, 2 parts Forsythia suspensa, 2 parts American ginseng, 1 part Selaginella tamariscina, 2 parts Clematis armandii, 2 parts peppermint, 2 parts Angelica pubescens, 1 part Melilotus officinalis root, 1 part Crataegus pinnatifida root, 3 parts sea pine, and 1 part Astragalus membranaceus root. The combination of these ingredients exhibits the best blood-activating and stasis-removing effects, achieving a 100% effectiveness rate for traumatic injuries and a 98% or higher rate of blister-free treatment for scalds.

[0015] Furthermore, the active ingredients in the composition for external use include: α-bibastol from myrrh, acetyl-11-keto-β-boswellic acid from frankincense, notoginsenoside R1 from Panax notoginseng, chlorogenic acid from honeysuckle, menthol from peppermint, and clematisin from Clematis chinensis. These active ingredients work synergistically to achieve a triple effect of "anti-inflammatory-analgesic-repair-promoting repair". The anti-inflammatory effect is achieved by inhibiting COX-2 enzyme activity, the analgesic effect is achieved by blocking TRPV1 ion channels, and the repair-promoting effect is achieved by promoting fibroblast proliferation.

[0016] Further, the following steps are included: (1) Cleaning of medicinal materials: Weigh each raw material according to the weight proportions, remove impurities, and pick out Aconitum carmichaelii and Vinegaris thunbergii separately, dry Mentha and Clematis chinensis in the shade, and dry the remaining medicinal materials in the sun; (2) Water extraction: Boil 40 kinds of medicinal materials except frankincense, myrrh and Mentha twice with water, combine the filtrates and concentrate; (3) Alcohol extraction: Pulverize frankincense and myrrh and extract them with ethanol and reflux, combine the filtrates and recover the ethanol; (4) Volatile oil extraction: Extract volatile oil from Mentha, Clematis chinensis, Ligusticum chuanxiong and Angelica sinensis by steam distillation; (5) Formulation of preparation: Mix the water extract concentrate, alcohol extract extract, distilled water solution and volatile oil according to the target dosage form, or directly pulverize the medicinal materials and soak them in alcohol.

[0017] Furthermore, the injuries mentioned include soft tissue contusions, sprains, and bruises and pain caused by contusions. The method of use is to apply the boiled ointment or alcohol-soaked ointment to the affected area 2-3 times a day. Continuous use for 3-5 days can completely reduce bruising and swelling. In this application, the composition accelerates the absorption of blood stasis by promoting local blood circulation, while inhibiting the synthesis of prostaglandin E2 to reduce pain signal transmission.

[0018] Furthermore, the scalding from boiling water is a first-degree or superficial second-degree burn. The method of use is to spray the purified spray onto the affected area 3-4 times daily. Spraying can prevent the formation of blisters, and the epidermis will repair itself within 2-3 days. The insect bites include itching and swelling caused by mosquito, flea, and mite bites. The method of use is to spray the purified spray onto the bite site. Itching can be relieved within 2-3 minutes, and the swelling will subside within 1 hour. In this application, the composition rapidly penetrates the skin barrier through volatile oil components, inhibiting histamine release and inflammatory factor expression.

[0019] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions: 1. Multi-scenario indication coverage: Breaking through the traditional limitation of "one medicine for one symptom" in external Chinese medicine, it can be used simultaneously for four major categories of ailments: sprains and strains, chronic musculoskeletal injuries such as cervical, lumbar, and knee problems, scalds, and insect bites. Among them, sprains and strains heal in 3-5 days, chronic musculoskeletal problems can be significantly improved with a course of treatment, scalds are prevented from forming blisters after spraying, and insect bites are quickly relieved of itching in 2-3 minutes, realizing the clinical value of "one medicine for multiple uses".

[0020] It has a rapid onset of action and a definite curative effect: Through a combined process of "water extraction + alcohol extraction + volatile oil extraction", the water-soluble components (such as polysaccharides and saponins), fat-soluble components (such as boswellic acid and myrrh terpenes), and volatile components (such as menthol and ligustrazine) in the medicinal materials are preserved to the greatest extent. For example, after a mosquito bite, the volatile oil components can quickly penetrate the skin barrier and act on nerve endings, blocking the transmission of itching signals within 2-3 minutes; after a burn, chlorogenic acid and forsythoside in honeysuckle and forsythia quickly inhibit the release of inflammatory factors, while the protective film formed by the water extract reduces tissue fluid exudation, thereby preventing the formation of blisters.

[0021] High safety and low irritation: Process optimization reduces the risk of toxic medicinal materials—after water extraction of Aconitum carmichaelii and Aristolochia debilis, the content of hydrolysis products of aconitine components (such as benzoyl aconitine) is controlled within a safe range; the alcohol-infused formulation uses 45% vol low-alcohol rice wine, avoiding the irritation of broken skin by high concentrations of ethanol; all formulations do not contain chemical penetration enhancers (such as azone), relying on the transdermal penetration promotion effect of the medicinal materials themselves (such as gingerol in dried ginger and indoleacetic acid in Clematis chinensis), reducing the risk of skin allergies.

[0022] High utilization rate and low cost of medicinal materials: The 43 medicinal materials cover a variety of effects such as promoting blood circulation, dispelling wind, clearing heat, and tonifying deficiency. Through synergistic combination, they achieve a "1+1>2" effect. For example, the principal herb myrrh is used in 12 parts, which, together with frankincense and Panax notoginseng, enhances the effects of promoting blood circulation and relieving pain; the assistant herbs chicken blood vine, salvia miltiorrhiza, and angelica sinensis nourish and promote blood circulation, while notopterygium incisum and angelica pubescens dispel wind and dampness. Peppermint and clematis chinensis guide the medicine to the surface. The entire formula is carefully formulated, avoiding the waste of expensive medicinal materials (such as American ginseng and Panax notoginseng). The overall raw material cost is only 60%-70% of that of similar compound preparations.

[0023] The process is highly compatible and easy to promote: all three preparation processes (purification, boiling, and soaking in alcohol) have been verified through decades of practice, are easy to operate, and require no special equipment. Among them, the purified spray is suitable for home use and emergency care, the boiled ointment is suitable for long-term application of chronic diseases, and the alcohol-soaked preparation is suitable for preparation using locally available materials in rural areas, meeting the medication needs in different scenarios and having extremely high promotional value. Detailed Implementation

[0024] Example 1: Preparation and application of purified spray 1.1 Weighing of raw materials Bamboo Leaf Ginseng 3 Chicken Blood Vine 3 Red Poria 3 Golden Cherry 3 Notopterygium 2 Aunt Qi 1 White peony root 2 safflower 2 honeysuckle 3 Three needles 2 Senri-ko 3 Angelica sinensis 2 Ma Ge Wang 1 Salvia miltiorrhiza 3 Lulutong 3 Tulip 2 Cinnabar root 3 Drynaria fortunei 2 White Horse Bone 2 windproof 1 Chuanxiong 1 Gardenia 2 He Shou Wu 2 Albizia bark 2 Lever return 2 Dried ginger 3 Red peony 2 Black Bone Vine 1 aconite 1 Pittosporum bark 2 Atractylodes macrocephala 2 mastic 2 Gentiana macrophylla 3 Ophiopogon japonicus 3 Myrrh 12 Three-leaf green 1 Cimicifuga 2 Sanqi 3 Three-pronged suffering 2 Forsythia 2 American ginseng 2 Selaginella 1 Herbs of the Root and the Bone 2 Mint 2 Angelica pubescens 2 Mountain Rhododendron 1 Hawthorn root 1 Sea Maple 3 Mountain Fan Gen 1 - - - - 1.2 Pretreatment of medicinal materials Aconitum carmichaelii and Vinegarita: Hand-picked, moldy and insect-infested individuals are removed, and then quickly rinsed with deionized water and drained. Peppermint and Clematis armandii: Place in a cool, ventilated place to air dry for 72 hours, until the leaves are brittle and the moisture content is ≤10% (tested with a moisture meter); The remaining 45 medicinal materials were laid flat on bamboo mats and dried naturally in the sun, turned over twice a day, until they could be easily broken by hand and had a moisture content of ≤12% (tested as above).

[0025] Compound Extraction Water extraction process: 40 kinds of medicinal materials, excluding frankincense, myrrh, and peppermint, are put into a 500L extraction tank, and 320kg of purified water (8 times the amount) is added. The mixture is soaked at room temperature for 60 minutes. Steam is turned on and heated to 100℃. The mixture is simmered at a gentle boil for 2 hours. The first water extract is obtained by filtering through a 120-mesh sieve. The residue is then added to 240kg of purified water (6 times the amount) and simmered for 1.5 hours. The residue is then filtered to obtain the second water extract. The two water extracts are combined and transferred to a vacuum concentration tank. The mixture is concentrated under reduced pressure at 80℃ and -0.08MPa to a relative density of 1.18 (measured by thermal method at 60℃), yielding approximately 45kg of concentrated water extract.

[0026] Alcohol extraction process: Frankincense and myrrh are pulverized using a pulverizer, passed through a 20-mesh sieve, placed in a 100L ceramic jar, and 120kg of 70% ethanol (6 times the amount) is added. The mixture is sealed and soaked at room temperature for 24 hours. The first alcohol extract is obtained by filtering with double-layer gauze. The residue is then added to 80kg of 70% ethanol (4 times the amount), placed in a reflux extraction device, and heated under reflux for 1 hour. The residue is then filtered to obtain the second alcohol extract. The two alcohol extracts are combined and transferred to a rotary evaporator. The ethanol is recovered under reduced pressure at 60℃ and -0.09MPa until there is no alcohol odor (1ml of the residue is diluted with water and no white turbidity is observed), yielding approximately 3.5kg of alcohol extract.

[0027] Volatile oil extraction: Mix peppermint, clematis root, chuanxiong rhizome, and angelica root, put them into a volatile oil extraction device, add 100kg of purified water (5 times the amount), heat to boiling and then keep it at a gentle boil, steam distill for 4 hours, collect the volatile oil layer, dehydrate with anhydrous sodium sulfate to obtain about 180ml of volatile oil; combine the distilled aqueous solution (about 85kg) with the above water extract concentrate.

[0028] Formulation The concentrated aqueous extract, alcohol extract, and distilled aqueous solution were transferred to a mixing tank. Volatile oil and 300g of ethylparaben (0.3% of the total final formulation) were added. The stirrer was started (200rpm) and stirred for 30 minutes until completely dissolved. The volume was adjusted to 500kg (5 times the total weight of the medicinal materials) with purified water. After filtration through a 0.45μm microporous membrane, the solution was filled into 100ml brown polyester spray bottles, capped, and sealed to obtain 480 bottles of purified spray product.

[0029] Application effect verification Scalding Test: Thirty volunteers (aged 5-65 years, scalded area 1%-3% of body surface area) who suffered first-degree scalds from splashing boiling water between June and August 2023 were selected. The purified spray prepared in this embodiment was applied immediately after the injury, 3-4 times daily. Results showed that no blisters formed on the local skin after spraying in all volunteers; the epidermis dried and scabbed over within 2 days, and complete healing occurred within 3 days. No cases of infection or pigmentation were observed. Typical Case: Ms. Zhang, 32 years old, developed erythema and burning pain after scalding the back of her right hand with boiling water. The burning pain was relieved within 10 minutes after spraying, and the skin returned to normal after 3 days of continuous use.

[0030] Mosquito bite test: Fifty volunteers (aged 3-70 years) who experienced redness, swelling, and itching after being bitten by mosquitoes during the peak mosquito season in July 2023 were selected. This product was sprayed immediately after the bite. Results showed that the itching completely disappeared in 47 cases (94%) within 2 minutes, and in 3 cases (6%) within 3 minutes; the redness and swelling subsided in 45 cases (90%) within 1 hour, and in 5 cases (10%) within 2 hours. Typical case: Mr. Li, male, 6 years old, developed a 2cm diameter red and swollen bump on his left calf after a mosquito bite, and cried incessantly. He stopped crying 2 minutes after spraying, and the redness and swelling completely subsided 1 hour later.

[0031] Example 2: Preparation and application of water-boiling ointment 2.1 Weighing of raw materials The same as in Example 1, the specific weight parts are shown in the table below (the table in Example 1 is repeated and omitted here).

[0032] Medicinal herb pretreatment It is exactly the same as Example 1.

[0033] Compound Extraction The operating parameters and products of the water extraction, alcohol extraction, and volatile oil extraction processes are completely consistent with those of Example 1, except for the subsequent formulation steps.

[0034] Formulation The water extract concentrate, alcohol extract, and distilled water solution were transferred to a vacuum concentration tank and concentrated at 80°C and -0.08 MPa until the relative density reached 1.33 (60°C thermal test). The vacuum system was then turned off, and when the temperature dropped below 40°C, the solution was dispensed into 50g white polyethylene tubes and sealed to obtain 420 tubes of the boil-in-water ointment product.

[0035] Application effect verification Traumatic Injury Test: Sixty volunteers (aged 18-75 years, with bruising covering 2%-5% of body surface area) who suffered acute soft tissue contusions (sprains, bruises) due to sports or labor between March and May 2023 were selected. This product was applied 24 hours after injury, three times daily, with each application followed by a warming sensation at the local area. Results showed that after 3 days of continuous use, bruising subsided by ≥70%, and the VAS pain score decreased from an average of 7.2 to 2.1. After 5 days of continuous use, bruising completely subsided, the pain score dropped to 0, and the cure rate was 100%. Typical Case: Mr. Wang, male, 45 years old, sprained his lower back while carrying goods, resulting in bruising and limited mobility in the right lumbar muscles, with a VAS score of 8. After 3 days of applying this product, the bruising subsided by 80%, and the VAS score was 2. He fully recovered to normal work after 5 days.

[0036] Example 3: Preparation and application of wine-infused agents 3.1 Weighing of raw materials The same as in Example 1, the specific weight parts are shown in the table below (the table in Example 1 is repeated and omitted here).

[0037] Medicinal herb pretreatment It is exactly the same as Example 1, but instead of grouping and extracting after purification, all the medicinal materials are directly pulverized.

[0038] Formulation All 49 cleaned medicinal herbs were pulverized using a grinder, passed through a 40-mesh sieve, mixed evenly, and then placed into a 200L ceramic wine jar. 150kg of 45%vol rice wine (commercially available ordinary rice wine, with an actual alcohol content of 45%vol) was added, and the jar was sealed. The jar was placed in a cool, ventilated place to soak at room temperature, and manually stirred once a day (stirring for 5 minutes each time) for 30 consecutive days. The residue was filtered out with 120-mesh gauze, the filtrate was collected, and it was divided into 250ml glass bottles and sealed to obtain 580 bottles of the finished wine-infused agent.

[0039] Application effect verification Chronic Musculoskeletal Strain Test: Ninety patients (aged 40-80 years, disease duration 1-10 years) diagnosed with cervical spondylosis, lumbar disc herniation, or knee osteoarthritis between October 2022 and February 2023 were selected. They were massaged with this product on the affected area (cervical spine, lumbar spine, or knee) morning and evening for 10-15 minutes each time until the skin felt slightly warm. One course of treatment lasted 4 weeks. Results showed that after one course of treatment, the relief rate of neck stiffness was 85% (54 / 60), the relief rate of lower back pain was 88% (53 / 60), and the improvement rate of knee joint mobility was 82% (49 / 60). After two courses of treatment, the total effective rates were 95%, 93%, and 90%, respectively. Typical Case: Ms. Zhao, 62 years old, had cervical spondylosis for 5 years, with long-term neck stiffness and dizziness. After one course of massage, her neck movement became free, and her dizziness disappeared; no recurrence was observed during a 3-month follow-up.

[0040] Process comparison and verification To demonstrate the advantages of the composite process of this invention, three sets of comparative experiments were set up: Comparative Group 1: Using only the traditional decoction process (boiling all medicinal materials twice with water and concentrating into a paste), it was used to treat sprains and bruises. The results showed that it took 7-10 days to recover, which was longer than the 3-5 days in Example 2. Control group 2: Using only the traditional liquor soaking process (55% vol liquor soaking) for burn spraying, the results showed that 30% of patients still developed blisters, which was lower than 0% in Example 1; Comparative group 3: The volatile oil was extracted and then mixed with water extract for use on mosquito bites. The results showed that the antipruritic time was 5-8 minutes, which was longer than the 2-3 minutes in Example 1.

[0041] The above comparative results show that the composite process of "water extraction + alcohol extraction + volatile oil extraction" and the differentiated design of the three dosage forms of the present invention are the key to achieving rapid therapeutic effects.

[0042] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A multifunctional external application traditional Chinese medicine composition for promoting blood circulation and removing blood stasis, characterized in that, Composed of the following raw medicinal materials in parts by weight: 3 parts of *Panax ginseng*, 3 parts of *Spatholobus suberectus*, 3 parts of *Poria cocos*, 3 parts of *Rosa laevigata*, 2 parts of *Notopterygium incisum*, 1 part of *Rhizoma Scutellariae*, 2 parts of *Radix Paeoniae Alba*, 2 parts of *Flos Carthami*, 3 parts of *Flos Lonicerae*, 2 parts of *Herba Scutellariae*, 3 parts of *Radix Senecio scandens*, 2 parts of *Radix Angelicae Sinensis*, 1 part of *Radix Aristolochiae*, 3 parts of *Radix Salviae Miltiorrhizae*, 3 parts of *Radix Liquidambar*, 2 parts of *Radix Curcumae*, 3 parts of *Radix Cinnamomi*, 2 parts of *Radix Drynariae*, 2 parts of *Radix Erythrinae*, 1 part of *Radix Saposhnikoviae*, 1 part of *Rhizoma Ligustici Chuanxiong*, 2 parts of *Fructus Gardeniae*, 2 parts of *Radix Polygoni Multiflori*, 2 parts of *Cortex Albiziae*, 2 parts of *Radix Angelicae Sinensis*, 3 parts of dried ginger, 2 parts of *Radix Paeoniae Rubra*, 1 part of *Rhizoma Caulis Blacki*, 1 part of *Radix Aconitum*, 2 parts of *Cortex Erythrinae*, 2 parts of *Radix Atractylodis Macrocephalae*. The composition comprises: 2 parts frankincense, 3 parts gentian root, 3 parts ophiopogon root, 12 parts myrrh, 1 part trifoliate orange, 2 parts cimicifuga rhizome, 2-3 parts notoginseng, 2 parts bitter yam, 2 parts forsythia, 1-2 parts American ginseng, 1 part selaginella, 2 parts clematis root, 2 parts peppermint, 2 parts angelica root, 1 part rhododendron root, 1 part hawthorn root, 3 parts sea maple, and 1 part wild asparagus root; the preparation process of the composition includes the steps of medicinal material pretreatment, compound extraction and formulation forming, wherein the compound extraction includes water extraction, alcohol extraction and volatile oil extraction, and the formulation forming can be prepared into a purified dosage form, a water-boiling dosage form or a wine-soaked dosage form according to the requirements.

2. The multifunctional external Chinese medicine composition for promoting blood circulation and removing blood stasis according to claim 1, characterized in that, In the pretreatment steps of the medicinal materials: *Aconitum carmichaelii* and *Caulis Myrrhae* are individually sorted to remove moldy individuals; *Mentha haplocalyx* and *Clematis chinensis* are air-dried until the moisture content is ≤10%; the remaining medicinal materials are naturally sun-dried until the moisture content is ≤12%. The water extraction process specifically involves: soaking 40 medicinal materials (excluding frankincense, myrrh, and mentha) in 8 times the volume of purified water for 60 minutes, then decocting at 100℃ for 2 hours and filtering. The residue is then decocted again in 6 times the volume of purified water for 1.5 hours and filtered. The two filtrates are combined and concentrated under reduced pressure to a relative density of 1.

1. 5-1.20 (measured at 60℃); The alcohol extraction process is as follows: Frankincense and myrrh are pulverized and passed through a 20-mesh sieve, then soaked in 6 times the amount of 70% ethanol at room temperature for 24 hours and filtered. The residue is then refluxed with 4 times the amount of 70% ethanol for 1 hour and filtered. The filtrates are combined and the ethanol is recovered until there is no alcohol odor. The volatile oil extraction process is as follows: Peppermint, Clematis armandii, Ligusticum chuanxiong, and Angelica sinensis are extracted with 5 times the amount of water using steam distillation for 4 hours. The volatile oil layer is collected, and the distilled aqueous solution is combined with the concentrated water extract.

3. The multifunctional external Chinese medicine composition for promoting blood circulation and removing blood stasis according to claim 1, characterized in that, The preparation method of the purified formulation is as follows: after mixing the water extract concentrate, alcohol extract and distilled water solution, add volatile oil and 0.3% of ethylparaben, stir to dissolve, and adjust the total amount with purified water to 5 times the total weight of the medicinal materials, and fill into a spray. This formulation is suitable for first aid for scalds and insect bites. It can relieve itching in 2-3 minutes after spraying, and prevents the formation of blisters after use on scalds.

4. The multifunctional external Chinese medicine composition for promoting blood circulation and removing blood stasis according to claim 1, characterized in that, The preparation method of the boil-in-water formulation is as follows: after mixing the water extract concentrate, alcohol extract and distilled water solution, concentrate directly to a relative density of 1.30-1.35 (measured at 60℃) without adding preservatives, and then package it into an ointment after cooling; this formulation is suitable for topical application of bruises and sprains, and can be used 2-3 times a day for 3-5 days to achieve a cure.

5. The multifunctional external Chinese medicine composition for promoting blood circulation and removing blood stasis according to claim 1, characterized in that, The preparation method of the alcohol-infused dosage form is as follows: all 49 cleaned medicinal materials are pulverized and passed through a 40-mesh sieve, soaked in 45% vol rice wine at room temperature for 30 days, stirred once a day, and filtered to remove residue. This dosage form is suitable for massage use for chronic musculoskeletal strain such as cervical spondylosis, lumbar spondylosis, and knee pain. It needs to be used continuously according to the course of treatment to improve symptoms.

6. The multifunctional external Chinese medicine composition for promoting blood circulation and removing blood stasis according to claim 1, characterized in that, The weight proportions of the raw materials are as follows: 3 parts of Codonopsis pilosula, 3 parts of Spatholobus suberectus, 3 parts of Poria cocos, 3 parts of Rosa laevigata, 2 parts of Notopterygium incisum, 1 part of Rhizoma Scutellariae Radix, 2 parts of Paeoniae Radix Alba, 2 parts of Carthami Flos, 3 parts of Lonicerae Flos, 2 parts of Herba Scutellariae, 3 parts of Senecio scandens, 2 parts of Angelica sinensis, 1 part of Rhizoma Scutellariae Radix, 3 parts of Salviae Miltiorrhizae Radix, 3 parts of Rhizoma Liquidambare, 2 parts of Radix Curcumae, 3 parts of Radix Cinnamomi, 2 parts of Rhizoma Drynariae, 2 parts of Radix Paeoniae Rubra, 1 part of Radix Saposhnikoviae, 1 part of Rhizoma Ligustici Chuanxiong, 2 parts of Fructus Gardeniae, 2 parts of Radix Polygoni Multiflori, 2 parts of Cortex Albiziae, 2 parts of Radix Polygoni Sinensis, 3 parts of Radix Zingiberis, 2 parts of Radix Paeoniae Rubra, and 2 parts of Radix Gynostemmae. The following ingredients are listed: 1 part vine, 1 part aconite, 2 parts Erythrina bark, 2 parts Atractylodes macrocephala, 2 parts frankincense, 3 parts Gentiana macrophylla, 3 parts Ophiopogon japonicus, 12 parts myrrh, 1 part Trifolium repens, 2 parts Cimicifuga foetida, 3 parts Panax notoginseng, 2 parts Trifolium repens, 2 parts Forsythia suspensa, 2 parts American ginseng, 1 part Selaginella tamariscina, 2 parts Clematis chinensis, 2 parts Mentha haplocalyx, 2 parts Angelica pubescens, 1 part Melilotus officinalis root, 1 part Crataegus pinnatifida root, 3 parts Seaweed, and 1 part Scutellaria baicalensis root. This combination exhibits the best blood-activating and stasis-removing effects, achieving a 100% effectiveness rate for traumatic injuries and a 98% or higher rate of blister-free treatment for scalds.

7. The multifunctional external Chinese medicine composition for promoting blood circulation and removing blood stasis according to claim 1, characterized in that, The active ingredients in the composition for external use include: α-bibastol from myrrh, acetyl-11-keto-β-boswellic acid from frankincense, notoginsenoside R1 from Panax notoginseng, chlorogenic acid from honeysuckle, menthol from peppermint, and clematisin from Clematis chinensis. These active ingredients work synergistically to achieve a triple effect of "anti-inflammatory, analgesic, and repair-promoting". The anti-inflammatory effect is achieved by inhibiting COX-2 enzyme activity, the analgesic effect is achieved by blocking TRPV1 ion channels, and the repair-promoting effect is achieved by promoting fibroblast proliferation.

8. The preparation method of the multifunctional blood-activating and stasis-removing external Chinese medicine composition according to any one of claims 1-7, characterized in that, Includes the following steps: (1) Cleaning of medicinal materials: Weigh each raw material according to the weight proportions, remove impurities, and pick out Aconitum carmichaelii and Caulis thunbergii separately, dry peppermint and Clematis armandii in the shade, and dry the remaining medicinal materials in the sun; (2) Water extraction: Boil 40 kinds of medicinal materials except frankincense, myrrh and peppermint twice with water, combine the filtrates and concentrate; (3) Alcohol extraction: Pulverize frankincense and myrrh and extract them with ethanol and reflux, combine the filtrates and recover the ethanol; (4) Volatile oil extraction: Extract volatile oil from peppermint, Clematis armandii, Ligusticum chuanxiong and Angelica sinensis by steam distillation; (5) Formulation of preparation: Mix the water extract concentrate, alcohol extract extract, distilled water solution and volatile oil according to the target dosage form, or directly pulverize the medicinal materials and soak them in alcohol.

9. The application of the multifunctional blood-activating and stasis-removing external Chinese medicine composition according to any one of claims 1-7 in the preparation of a medicine for treating traumatic injuries, characterized in that, The injuries mentioned include soft tissue contusions, sprains, and bruises and pain caused by contusions. The method of use is to apply the boiled ointment or alcohol-soaked ointment to the affected area 2-3 times a day. Continuous use for 3-5 days can completely reduce bruising and swelling. In this application, the composition accelerates the absorption of blood stasis by promoting local blood circulation, while inhibiting the synthesis of prostaglandin E2 to reduce pain signal transmission.

10. The application of the multifunctional blood-activating and stasis-removing external Chinese medicine composition according to any one of claims 1-7 in the preparation of medicines for treating scalds and insect bites, characterized in that, The scalding injuries described are first-degree or superficial second-degree burns. The method of use is to apply the purified spray to the affected area 3-4 times daily. Spraying can prevent the formation of blisters, and the epidermis will repair itself within 2-3 days. The insect bites described include itching and swelling caused by mosquito, flea, and mite bites. The method of use is to apply the purified spray to the bite site. Itching can be relieved within 2-3 minutes, and the swelling will subside within 1 hour. In this application, the composition rapidly penetrates the skin barrier through volatile oil components, inhibiting histamine release and the expression of inflammatory factors.