A traditional Chinese medicine composition for treating damp-heat and blood stasis and its preparation method

Abstract

The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a kind of external traditional Chinese medicine composition for treating damp-heat stasis and toxic swelling and pain and a preparation method thereof, which is composed of mirabilite, wine rhubarb, gardenia, clear pinellia, borneol, golden cypress, atractylodes, and raw jackinthepulp in portions; the composition is prepared through drying, ultrafine grinding, and three-dimensional mixing, and can be prepared into different matrix pastes in clinic, and synergizes with physical osmotic pressure regulation and pharmacological dredging, the application significantly enhances the effects of softening and resolving masses and promoting blood circulation to remove blood stasis, improves drug bioavailability, shortens the onset time, and realizes the unity of high efficiency and high safety.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically a topical traditional Chinese medicine composition for treating damp-heat stagnation and swelling pain, and its preparation method. Background Technology

[0002] From the combined perspective of traditional Chinese medicine and modern clinical medicine, redness, swelling, heat, and pain in local tissues are generally considered the result of the combined effects of multiple complex pathological factors. Especially in the acute phase of traumatic injuries, the acute phase of gouty arthritis, the early stage of herpes zoster, and the onset of various sores and carbuncles, the core pathogenesis often manifests as the mutual binding of damp-heat and blood stasis toxins. This pathological state not only involves the cascade reaction of inflammatory factors but also includes local microcirculatory disorders, accumulation of tissue metabolites, and the continuous release of pain-causing substances. For such conditions, topical medication has shown irreplaceable advantages in clinical application because it can directly reach the lesion and avoid the first-pass effect of the liver and gastrointestinal irritation.

[0003] Existing topical methods for reducing swelling and relieving pain are mainly divided into two categories: chemical drugs and traditional Chinese medicine preparations. In the field of chemical drugs, nonsteroidal anti-inflammatory drugs (NSAIDs) such as diclofenac diethylamine emulsion or corticosteroid ointments are often used in clinical practice. Although these drugs have definite efficacy in inhibiting prostaglandin synthesis and relieving inflammatory pain in the short term, their limitations are becoming increasingly prominent. On the one hand, long-term or large-area use of hormone preparations can easily induce iatrogenic damage such as skin atrophy, telangiectasia, and pigmentation. On the other hand, NSAIDs can only block a single link in the inflammatory response and lack a synergistic effect in clearing away the deep-seated damp-heat and blood stasis in traditional Chinese medicine theory. As a result, they often face the dilemma of treating the symptoms but not the root cause when dealing with complex swelling and pain, and the condition may even recur after the efficacy of the drug diminishes.

[0004] Meanwhile, traditional Chinese medicine external preparations such as Jinhuang San and Yulu San have accumulated rich experience in long-term clinical practice. However, with the evolution of modern disease patterns and patients' demand for more precise efficacy, these traditional prescriptions have gradually revealed deep contradictions in practical applications. First, the formulation logic of traditional prescriptions tends to focus on clearing heat or promoting blood circulation. When faced with complex pathogenesis involving dampness, heat, blood stasis, and toxins, they often lack systematic guidance on the combination of principal, assistant, and adjuvant herbs, resulting in weak targeted efficacy. Second, in terms of herbal selection, although some herbs with strong properties (such as raw Arisaema heterophyllum) have remarkable effects in dispersing nodules and reducing swelling, the lack of standardized safety evaluation and scientific compatibility inhibition makes it difficult to control their potential local irritation, limiting their wide application in clinical practice.

[0005] A more critical technical bottleneck lies in the transdermal absorption efficiency of drugs. Traditional topical powders are limited by the preparation process at the time, and their physical properties are usually relatively rough with uneven particle size distribution. This directly leads to insufficient contact between the active ingredients and the skin surface, making it difficult for drug molecules to penetrate the physical barrier of the stratum corneum. As a result, the effective blood drug concentration in the local tissue cannot quickly reach the therapeutic window. In addition, existing methods of applying traditional Chinese medicine often face the problem of single excipients, failing to fully consider the differences in the physiological state of the skin under different disease backgrounds. For example, when facing the bruises and swelling of traumatic injuries and the local burning of sores and heat toxins, the uniform preparation method not only affects the transdermal absorption rate of drugs, but also easily causes clothing contamination, reducing patient compliance.

[0006] At its core, the contradiction lies in the fact that existing technologies, when addressing localized swelling and pain, often present an irreconcilable trade-off between rapid effectiveness and radical cure, and between drug efficacy and skin safety. Specifically, in order to increase the speed of swelling reduction, it is often necessary to increase the proportion of potent medicinal materials, but this inevitably brings the risk of local allergies or damage; on the other hand, using mild formulations to ensure safety faces the problem of slow onset of action and inability to cope with pain during acute attacks.

[0007] Therefore, the present invention provides a topical traditional Chinese medicine composition for treating swelling and pain caused by damp-heat and blood stasis, and its preparation method. Summary of the Invention

[0008] To overcome the shortcomings of existing technologies and solve at least one technical problem raised in the background art The technical solution adopted by the present invention to solve its technical problem is: the external Chinese medicine composition for treating damp-heat stagnation and swelling pain and its preparation method, comprising the following components in parts by weight: 2-3 parts Glauber's salt, 2-3 parts rhubarb (processed with wine), 2-3 parts gardenia, 2-3 parts processed pinellia, 2-3 parts borneol, 1-2 parts phellodendron bark, 1-2 parts atractylodes, and 1.5-2 parts raw arisaema.

[0009] Preferably, the external Chinese medicine composition for treating damp-heat stagnation and swelling is composed of the following components in parts by weight: 2 parts Glauber's salt, 2 parts rhubarb (processed with wine), 2 parts gardenia, 2 parts processed pinellia, 2 parts borneol, 1 part phellodendron bark, 1 part atractylodes, and 1.6 parts raw arisaema.

[0010] Preferably, Glauber's salt, as one of the principal herbs, has sodium sulfate as its main component. In external applications, its high osmotic pressure properties can induce water in the interstitial spaces to migrate towards the high-concentration medicinal solution, thereby achieving significant effects of softening and dispersing nodules, clearing heat and reducing swelling. Rhubarb, as another principal herb, contains anthraquinone derivatives such as rhein and chrysophanol. After being processed by wine-processing, its ability to promote blood circulation, remove blood stasis, and unblock meridians is greatly enhanced. It can effectively remove blood clots and inflammatory metabolites in the local microcirculation. Together with Glauber's salt, it constitutes the core driving force for purging heat, breaking up blood stasis, reducing swelling and relieving pain.

[0011] Preferably, Gardenia, as the assistant herb, contains geniposide and genipin, which can clear damp-heat in the lower burner. While cooling the blood and detoxifying, it works in conjunction with the principal herb to enhance the effect of clearing heat and purging fire. Phellodendron bark, through its cyperine and berberine components, can specifically clear damp-heat pathogens in the lower burner and local skin tissues. Arisaema, as the key assistant herb in this invention, has a strong medicinal property and is specifically designed for stubborn lumps and phlegm stagnation. Through its triterpenoid saponins, it achieves a strong effect of dispersing nodules, reducing swelling, and relieving wind and pain. It is particularly suitable for chronic and subacute swelling and pain caused by damp-heat and blood stasis.

[0012] Preferably, at the level of adjuvant medicine, Pinellia ternata, through its medicinal properties of drying dampness, resolving phlegm, eliminating lumps and dissipating nodules, can assist the principal and assistant medicines in resolving local stagnation of phlegm and dampness, preventing dampness from lingering and difficult to cure. Atractylodes lancea, on the other hand, plays the role of drying dampness and strengthening the spleen, and enhances the metabolic vitality of local skin through its volatile oil components, thus achieving both symptomatic and root-cause treatment.

[0013] Preferably, borneol, as the adjuvant in this invention, has extremely strong transdermal penetration properties. It can temporarily change the lipid arrangement between cells in the stratum corneum of the skin, reduce the resistance of the skin's physical barrier, and thus guide the effective molecules of each drug in the formula to quickly penetrate the stratum corneum and reach the dermis and deep tissues. When borneol is combined with other drugs, it not only plays the role of guiding the drugs directly to the affected area, but its own cooling sensation can also quickly relieve the burning pain caused by heat toxicity.

[0014] Preferably, the present invention controls the proportions of each component at critical points to ensure a dynamic balance between efficacy and safety. The present invention clarifies the mechanism by which the variation range of the weight fractions of each component affects the final efficacy.

[0015] The weight percentage of Glauber's salt is set to 2-3 parts. When the Glauber's salt content is less than 1 part, the osmotic pressure generated by the drug is insufficient to cause effective reflux of interstitial fluid, resulting in a significant reduction in the effects of softening and dispersing nodules and reducing edema. When the Glauber's salt content is higher than 3 parts, the high concentration of inorganic salts will cause excessive loss of local skin moisture, inducing dry skin, peeling, and even micro-cracks, resulting in strong irritation.

[0016] The weight percentage of the rhubarb used in the wine is set to 2-3 parts. When the content of the rhubarb used in the wine is less than 1 part, its ability to promote blood circulation and remove blood stasis is insufficient to clear the microcirculatory stagnation that has already formed. If its content is higher than 3 parts, due to the strong dilating effect of anthraquinone substances on local capillaries, some patients with sensitive skin may experience local allergic erythema or contact dermatitis.

[0017] The weight percentage of the raw Arisaema is set at 1.5-2 parts. The content of this component is the core indicator for controlling safety. When the content is less than 1 part, its effect of dispersing nodules is difficult to meet the clinical treatment requirements for stubborn swelling and pain and deep accumulation of damp-heat and blood stasis. When the content is higher than 2 parts, the alkaloids contained in raw Arisaema heterophyllum have a certain degree of toxicity to peripheral nerves and skin tissues, and the local irritation will increase significantly, which can easily lead to a burning sensation or worsening of redness and swelling of the skin.

[0018] The weight percentage of borneol is set to 2-3 parts. When the borneol content is less than 1 part, the effect of its penetration enhancer cannot be effectively activated, resulting in a slow onset of the overall drug effect. If the concentration is higher than 3 parts, the excessive cooling sensation may interfere with the patient's judgment of the condition and may cause chemical burns to the skin and mucous membranes. The present invention also provides a method for preparing the above-mentioned topical Chinese medicine composition, which maximizes the retention and enhances the release efficiency of the active pharmaceutical ingredients through the synergistic effect of physical means.

[0019] The preparation method includes the following steps: Raw material pretreatment: The eight medicinal materials are cleaned and impurities are removed. They are then dried in a drying oven to control the moisture content of each medicinal material to be below 9%. Strict control of the drying moisture is to prevent the active ingredients of the medicine from hydrolyzing or denaturing due to heat accumulation during the subsequent ultrafine grinding process.

[0020] Ultrafine grinding: The pre-treated medicinal materials are mixed or processed separately according to the set weight ratio, and then ultrafinely ground using an air jet mill. The fineness of the ground powder needs to reach 200 mesh, that is, the average particle size of the powder particles is controlled below 75μm. The application of ultrafine grinding technology makes the surface area of ​​the powder increase exponentially, which greatly improves the effective contact area between the drug and the skin surface, and provides a physical prerequisite for the molecular diffusion of the active ingredients.

[0021] Three-dimensional mixing: The pulverized components are placed in a three-dimensional mixer and continuously mixed for 30 minutes under multi-directional motion. The three-dimensional mixing technology can effectively overcome the differences in specific gravity and particle size between powders, eliminate the gravity segregation phenomenon present in traditional stirring, and ensure that the eight medicinal ingredients in each unit volume of the composition are in a highly uniform distribution state.

[0022] Packaging and Storage: A fully automated dispensing machine is used to dispense the evenly mixed powder into double-layer composite film bags, which are then sealed to obtain the finished powder product. Preferably, as an extension of the present invention, the external herbal composition of the present invention can be formulated into pastes with different bases according to different types of symptoms of patients during clinical application, and the preparation method is as follows: The first method is to mix the powdered external Chinese medicine composition with honey at a weight ratio of 1:0.8 to 1:1.2. The fructose, glucose and enzymes in honey not only provide a moist excipient environment, but also have the physiological activity of moisturizing and promoting skin regeneration, and are suitable for general redness, swelling and pain.

[0023] The second method is vinegar application: the powdered external Chinese medicine composition is mixed with vinegar at a weight ratio of 1:0.8 to 1:1.2. The acetic acid component can promote the dissolution of alkaloid components and enhance the drug's ability to promote blood circulation, remove blood stasis, soften hard masses and disperse nodules. It is especially suitable for cases with severe local blood stasis and hard nodules after traumatic injuries.

[0024] The third method is to mix the powdered external Chinese medicine composition with strong tea at a weight ratio of 1:0.8 to 1:1.2. The astringent effect of tea polyphenols works synergistically with the heat-clearing and detoxifying components in the formula, which is suitable for patients in the acute phase of sores and carbuncles with obvious heat and toxicity.

[0025] The fourth method is egg white application: the powder of the external Chinese medicine composition is mixed with egg white at a weight ratio of 1:0.8 to 1:1.2. Egg white has good physical encapsulation properties and is mild in nature, with astringent and tissue-regenerating effects, and is especially suitable for patients with sensitive skin or allergies.

[0026] The beneficial effects of this invention are as follows: 1. The present invention discloses a topical Chinese medicine composition for treating swelling and pain caused by damp-heat and blood stasis, and its preparation method. By establishing Glauber's salt and rhubarb (processed with alcohol) as common principal drugs, a dual source of swelling reduction is constructed. Glauber's salt draws out tissue edema through the physical action of osmotic pressure gradient, while rhubarb (processed with alcohol) clears microcirculation blockage through chemically active substances. This combined action mode of physical suction and chemical clearing is significantly superior to existing single-effect topical preparations in the speed of edema reduction during traumatic injuries and acute gout attacks.

[0027] 2. The present invention discloses a topical Chinese medicine composition for treating swelling and pain caused by damp-heat and blood stasis, and its preparation method. This invention scientifically introduces the nodule-dispersing properties of raw Arisaema heterophyllum and supplements it with the penetration-enhancing effect of borneol. In traditional anti-swelling preparations, due to concerns about the irritation of raw Arisaema heterophyllum, its use is often avoided or the dosage is extremely low. Through precise formulation research, this invention has found the critical window for raw Arisaema heterophyllum to exert its nodule-dispersing and swelling-reducing effects without causing serious skin damage. By utilizing the transdermal guiding effect of borneol, the active ingredients of raw Arisaema heterophyllum can cross the stratum corneum and directly act on deep fibrotic nodules or inflammatory indurations, achieving deep clearance of blood stasis and toxins.

[0028] 3. The external Chinese medicine composition for treating damp-heat stagnation and swelling pain described in this invention and its preparation method, through the application of 200-mesh ultrafine pulverization and three-dimensional mixing technology, solves the technical problems of coarse particles and uneven component distribution in traditional powders. Particles with a fineness of less than 75μm can closely adhere to the skin texture and form a uniform molecular diffusion layer after being combined with excipients, which greatly improves the bioavailability of the drug and shortens the onset time of the drug effect by more than 30% compared with traditional preparations. Attached Figure Description

[0029] The invention will now be further described with reference to the accompanying drawings.

[0030] Figure 1 This is a flowchart of the preparation method of a topical Chinese medicine composition for treating swelling and pain caused by damp-heat and blood stasis in this invention; Figure 2 This is a comparison chart of VAS scores at different time points for two groups of patients in this invention; Figure 3 This is a comparison chart of the swelling difference between two groups of patients at different time points in this invention; Figure 4 This is a comparison chart of the preoperative waiting time for two groups of patients in this invention; Figure 5 This is a comparison chart of VAS scores at different time points for two groups of patients in this invention. Detailed Implementation

[0031] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below in conjunction with specific embodiments.

[0032] like Figures 1-5 As shown in the embodiment of the present invention, a topical Chinese medicine composition for treating swelling and pain caused by damp-heat and blood stasis includes the selection and proportion of its components based on a systematic intervention of the intertwined state of three pathological factors: damp-heat, blood stasis, and heat toxicity. Glauber's salt is the key physical active ingredient in the composition, and its main component is hydrated sodium sulfate, which occupies 2-3 parts by weight in the composition. During preparation and application, Glauber's salt forms a high osmotic pressure environment under the action of the dressing matrix. Its technical indicator is that it can generate a physical gradient on the skin surface that is sufficient to induce the reflux of interstitial fluid. Experiments have shown that when the weight of Glauber's salt is 2.5 parts, the osmotic pressure gradient formed in the 2 mm thick dressing layer can effectively promote the relaxation of the local precapillary sphincter, thereby accelerating the reabsorption of inflammatory exudates. The weight of rhubarb is set at 2-3 parts. After being processed by wine, the free proportion of anthraquinone derivatives such as emodin and chrysophanol contained in it is significantly increased. This is conducive to its passage through the stratum corneum under the guidance of borneol. In the formula, rhubarb interferes with the inflammatory cascade reaction through chemical activity. The physical-chemical synergistic chain formed by rhubarb and Glauber's salt is the technical basis for achieving rapid swelling reduction.

[0033] Furthermore, gardenia, as the core component for clearing heat and cooling blood, has a weight ratio of 2-3 parts. Genipin in gardenia can reduce the pain sensitivity of local tissues by inhibiting the activity of cyclooxygenase during the local biotransformation process of the skin. The ratio of phellodendron bark to atractylodes is controlled between 1-2 parts. This ratio ensures a dynamic balance between drying dampness and clearing heat. Berberine in phellodendron bark has extremely strong alkaloid polarity. After being ultra-finely pulverized to below 75μm, its dissolution rate in the matrix is ​​accelerated, which can directionally clear damp-heat evil qi from deep tissues. As a critical care medicine in this invention, the weight of raw Arisaema heterophyllum is strictly controlled between 1.5 and 2 parts. In specific engineering implementation, 1.6 parts was determined to be the optimal parameter that balances efficacy and safety. The triterpenoid saponins in raw Arisaema heterophyllum have a strong nodule-dispersing effect and can degrade existing fibrotic nodules. However, when the concentration exceeds 2 parts, its stimulation of peripheral nerves can cause non-therapeutic skin burns. Therefore, the measurement accuracy of this component is required to be within 0.01 parts.

[0034] like Figure 1 As shown, in terms of the implementation of the preparation process, the present invention adopts a set of strict physical parameter control procedures; First, the raw materials are pre-treated. Before entering the production line, each medicinal material must be dried in a constant temperature drying oven. The drying temperature is set at 55-60 degrees Celsius. This temperature range can ensure the removal of moisture without causing a large loss of volatile components such as borneol. The goal of drying is to control the moisture content of the medicinal materials to below 9%. Experimental data show that when the moisture content is 8.5%, the brittle modulus of the medicinal material is in the ideal range, which provides a good physical condition for subsequent ultrafine grinding. If the moisture content is higher than 10%, the increased adhesion between particles during the ultrafine grinding process will lead to a significant increase in heat generation, causing the powder to clump and the active ingredients to denature.

[0035] The ultrafine pulverization process is completed in an air jet mill. The core technology of air jet milling lies in using high-speed compressed air to drive medicinal particles to collide at high frequency in the pulverization chamber. In the embodiments of this invention, the pressure of the compressed air is controlled at 0.8-1.0 MPa. By adjusting the feed speed, the fineness of the produced powder is ensured to reach 200 mesh. According to the monitoring of the laser particle size distribution instrument, the average particle size of the obtained powder is distributed between 65 μm and 75 μm. The physical significance of this particle size level is that it is smaller than the average diameter of the hair follicle opening of human skin and can be tightly embedded between the skin grooves and papules. The specific surface area of ​​the particles after ultrafine pulverization is increased by 4-6 times compared with traditional mechanical pulverization. This directly leads to an exponential increase in the release efficiency of the active pharmaceutical ingredient in the preparation matrix.

[0036] Three-dimensional mixing is a key engineering step to ensure the consistency of the composition quality. The pulverized components are put into the three-dimensional mixer in proportion. The three-dimensional mixer, through its unique multi-axis linkage mechanism, makes the material in the container generate strong turbulent motion while rotating and turning. The mixing time is set to 30 minutes and the mixing speed is controlled at 25-30 rpm. Under this parameter combination, the physical differences between Glauber's salt (higher specific gravity) and borneol (lower specific gravity, easy to sublimate) are effectively compensated. Sampling and testing showed that after 30 minutes of mixing, the coefficient of variation of each component in the formula was less than 1.5%, achieving uniform compatibility at the microscopic level. The mixed powder was immediately sent to a fully automatic dispensing machine and sealed with nitrogen using a double-layer aluminum foil composite film to prevent borneol volatilization and Glauber's salt deliquescence, ensuring the quality stability of the finished powder within its shelf life.

[0037] The following details the specific proportions and preparation process of Example 1. In Example 1, 2 kg of Glauber's salt, 2 kg of rhubarb (processed with wine), 2 kg of gardenia, 2 kg of processed pinellia, 2 kg of borneol, 1 kg of phellodendron bark, 1 kg of atractylodes, and 1.6 kg of raw arisaema were selected. After cleaning, the herbs were placed in a drying oven and baked at 58 degrees Celsius for 4 hours. The moisture content was measured to be 8.2%. The airflow pulverization system was then activated, and the air pressure was adjusted to 0.9 MPa for pulverization. The resulting powder was passed through a 200-mesh sieve and transferred to a three-dimensional mixer, which was run at 30 rpm for 30 minutes. Finally, the powder was packaged. In clinical applications, the resulting product is used to treat patients with severe redness and swelling caused by acute sprains and bruises. The product is prepared by applying a vinegar-based paste: 50g of the powder is mixed with approximately 45g of aged vinegar to form a uniform paste, which is then applied to the affected area with a thickness of 2.5mm.

[0038] Comparative Example 1: The component ratio of Comparative Example 1 is the same as that of Example 1, but the preparation process adopts traditional mechanical grinding technology, and the powder fineness only reaches 80 mesh (about 180 μm), and is mixed for 10 minutes using a common single-shaft mixer.

[0039] To investigate the performance differences between Example 1 and Comparative Example 1, a specific experimental comparison was conducted. The experimental subjects were 60 outpatients with ankle sprains, who presented with obvious damp-heat stagnation and local high swelling. The patients were randomly divided into two groups: Group A used the powder prepared in Example 1, and Group B used the powder prepared in Comparative Example 1. Both were applied with vinegar. The VAS scores for pain and the swelling reduction rate were recorded at 12, 24, and 48 hours after medication.

[0040] The experimental data are shown in the table below: The data clearly show that Example 1 is significantly better than Comparative Example 1 in terms of analgesia speed and swelling reduction efficiency. 12 hours after administration, the VAS score of Example 1 decreased by more than 50%, while that of Comparative Example 1 decreased by only about 28%. In terms of swelling reduction, Example 1 achieved about 72% swelling reduction within 24 hours, while Comparative Example 1 only achieved 38.7%. This significant difference demonstrates the core contribution of the 200-mesh ultrafine pulverization and three-dimensional mixing process in improving the drug release rate and enhancing the drug's adhesion to the skin. Large powder particles (Comparative Example 1) have limited contact area and are prone to precipitation and uneven distribution in pastes, resulting in low migration efficiency of active molecules to the dermis.

[0041] The engineering implementation of the external Chinese medicine composition described in this invention is not limited to the laboratory scale. In industrial production, by introducing an online near-infrared spectroscopy monitoring system, the uniformity of component mixing during the three-dimensional mixing process can be monitored in real time. When the monitoring curve tends to be stable and meets the preset absorbance standard, the mixing is automatically terminated. This engineered parameter control ensures that the efficacy of each batch and each bag of medicine powder can reach the high standard shown in Example 1.

[0042] In the study of the transdermal absorption mechanism of the composition of the present invention, it was found that borneol, as a penetration enhancer, can generate more dense molecular-level collisions with the lipid bilayer of the stratum corneum when it is in the state of 200-mesh ultrafine pulverization. Borneol molecules temporarily change the ordered arrangement of lipids, creating multiple molecular channels, which allows the emodin in rhubarb and the saponins in raw arisaema to penetrate the stratum corneum with a thickness of about 10-20 μm through free diffusion. After entering the dermis, due to the high osmotic pressure created by Glauber's salt on the outer side of the skin, inflammatory cytokines in the interstitial fluid (such as interleukin-1β and tumor necrosis factor-α) are driven by the osmotic pressure difference and migrate towards the drug layer with the interstitial fluid, thereby realizing a physical detoxification process from the inside out.

[0043] Furthermore, regarding the dosage control of raw Arisaema heterophyllum, this invention verified the scientific validity of the range of 1.5-2 parts through a series of gradient experiments. When the content of raw Arisaema heterophyllum was 1.2 parts, the softening effect on indurations formed by old sprains and bruises took more than 7 days; while when the content was increased to 1.6 parts, the average softening time of the indurations was shortened to 3.5 days. However, when the content of raw Arisaema was increased to 2.5 parts in the experimental group, 25% of the subjects reported a strong stinging sensation in the local area and observed slight peeling of the skin epidermis. Therefore, the weight ratio of 1.6 to 1.8 parts is the key technical breakthrough achieved by this invention in balancing clinical efficacy and medication safety.

[0044] In long-term follow-up of clinical efficacy, the topical Chinese medicine composition of this invention showed good long-term prognosis. For patients in the rehabilitation period after ankle fracture, regular use of vinegar-mixed powder not only solved the early edema problem, but its blood-activating and stasis-removing effects also prevented adhesion of local soft tissues, making the recovery time of joint mobility 10-15 days earlier than that of the conventional rehabilitation group. This deep tissue repair effect is due to the continuous improvement of microcirculation by rhubarb, gardenia, and phellodendron.

[0045] In further optimization of the preparation process, this invention also discovered that the ambient humidity during fully automated dispensing has a significant impact on product quality. In specific engineering specifications, the relative humidity in the packaging workshop must be strictly controlled below 45%. If the humidity is too high, Glauber's salt will absorb moisture from the air to form water of crystallization, which will not only cause the powder to become less fluid and affect the accuracy of the filling, but also cause the internal pressure of the packaging bag to increase, resulting in powder leakage. By controlling the production environment, this invention ensures that the physical properties of the powder composition remain loose and do not clump during the two-year storage period.

[0046] When faced with large areas of skin redness and swelling (such as in the early stages of erysipelas), a strategy of segmented administration and targeted coverage can be adopted. The powder of this invention can be mixed with tea to form a fluid, which can be applied to a large area by spraying or applying a wet compress. Taking advantage of its broad heat-clearing and detoxifying abilities, clinical data show that after erysipelas patients received the composition of this invention, the time for the white blood cell count in the blood routine to return to normal was on average 2.4 days earlier than that of the group receiving intravenous antibiotics alone. This indicates that after the topical drug is absorbed through the skin and enters the peripheral circulation, it has a significant direct antagonistic effect on the local infection focus.

[0047] To demonstrate the therapeutic effect of the drug combination of this invention, this clinical observational study collected 60 inpatients in the orthopedic department of a hospital who met the criteria for ankle fracture and ankle edema. Following the principle of randomized controlled double-blind, they were randomly divided into two groups using a computer-generated random number table: an observation group of 30 patients and a control group of 30 patients. There were no statistically significant differences between the two groups in terms of disease condition, gender, age, etc., after statistical processing, and they were comparable. All patients included in the study signed informed consent forms, and the study was reviewed and approved by the hospital's medical ethics committee to comply with relevant ethical regulations (ethics approval number: KY-2025-057-01).

[0048] Diagnostic criteria: Referring to the diagnostic criteria for ankle fractures in the fourth edition of "Practical Orthopedics", all ankle fractures were diagnosed as Lauge-Hansen type IV based on physical examination, X-ray, CT and MRI results. After analysis and discussion by the research team, the cases included in the study were randomly divided into a control group and an experimental group.

[0049] Inclusion criteria (1) Patients admitted to the hospital within 24 hours of injury; (2) Those who meet the Lauge-Hansen classification criteria for supination-external rotation type IV ankle joint diagnosis; (3) Patients with unilateral closed fresh fractures; (4) Age between 18 and 65 years old, gender not limited; Patients who agree to surgical treatment, sign an informed consent form, and are able to cooperate with the treatment.

[0050] Exclusion criteria (1) Patients who do not meet the inclusion criteria; (2) Patients with multiple injuries in other parts of the body, pathological fractures, or infections; (3) Patients with neurovascular injury who require emergency surgery; (4) Long-term use of drugs with analgesic, anticoagulant, and anti-edema effects, and alcohol addiction; Patients with edema of the limbs caused by other internal medical conditions; Individuals with known allergies to any component of the treatment drug; Patients with comorbid severe cardiovascular, metabolic, hematopoietic, and mental illnesses who are unable to actively cooperate with treatment.

[0051] Treatment method: Patients were randomly divided into a control group and a treatment group. The control group was given flurbiprofen ester gel patch for external application, while the observation group was given the drug formula of this invention for external application. The traditional Chinese medicine preparation came from the hospital's preparation room. The medication was administered twice a day for 4 hours each time, and the observation period was 5 days.

[0052] Pain measurement: VAS score, or Visual Analogue Scale for Pain: Draw a 10cm horizontal line on a piece of paper. One end of the line is 0, which means no pain; the other end is 10, which means severe pain; the middle part represents different degrees of pain.

[0053] Swelling difference measurement: The circumference of the healthy and affected limbs was measured at different observation times before and after treatment. The measurement site was 3cm above the medial malleolus, and the difference was then recorded.

[0054] Preoperative waiting time: Record the preoperative waiting time for each group of patients.

[0055] Safety assessment: Blood routine tests, electrocardiograms, and liver and kidney function tests were performed on both groups of patients before and after treatment.

[0056] Statistical analysis: SPSS 22.0 statistical software was used for data processing. The t-test was used to compare the means before and after treatment within the group and between the groups for continuous data. Non-parametric tests were used for categorical data. P < 0.05 was considered statistically significant.

[0057] Comparison of VAS scores between the two groups before intervention and at 24h, 72h, and 120h: VAS scores of both groups were significantly reduced after intervention (P<0.05). Moreover, the observation group showed a significantly greater reduction in scores after treatment than the control group (P<0.05), indicating that the observation group significantly improved pain, and the difference was statistically significant.

[0058] Note: *P<0.05; **P<0.01 (n=30).

[0059] Comparison of swelling differences between the two groups before intervention and at 24h, 48h, 72h, 96h, and 120h: Both groups showed significant improvement in limb swelling after intervention (P<0.05). Moreover, the swelling in the observation group subsided significantly after treatment, which was better than that in the control group (P<0.05), indicating that the observation group showed more significant improvement in swelling, and the difference was statistically significant.

[0060] Note: *P<0.05; **P<0.01 (n=30) Comparison of preoperative waiting time between the two groups: The average waiting time in the observation group was 6.5 days, while that in the control group was 4.8 days, which was better than that in the control group (P<0.05). This means that the observation group can significantly shorten the preoperative waiting time of patients, and the difference is statistically significant.

[0061] To demonstrate the efficacy of the drug combination of the present invention in treating gout pain, a retrospective study was conducted on 60 gout patients who met the criteria for acute gout at the orthopedic outpatient clinic of a certain hospital. According to the matching principle, 30 patients were selected as the observation group and 30 patients as the control group. After statistical processing, there were no statistically significant differences between the two groups in terms of disease condition, gender, age, etc., and they were comparable.

[0062] Diagnostic criteria Referring to the 2015 ACR / EULAR classification criteria for gout and the "Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout (2019)," all cases were collected through the electronic medical record system, including medical history, physical examination records, laboratory test results (serum uric acid, renal function, inflammatory markers), and imaging data (joint ultrasound, dual-energy CT, or X-ray). Two researchers independently evaluated the data, and those meeting the diagnostic criteria were included in the study. After analysis and discussion by the research team, the cases were divided into a control group and an observation group.

[0063] Inclusion criteria (1) Patients who visited this hospital between June 2024 and February 2026; (2) Those who meet the 2015 ACR / EULAR gout classification criteria and have a score ≥8; (3) Acute gouty arthritis attack (single or few joints involved), attack time ≤48 hours, and clear record of the time of medical visit; (4) Complete medical records, including general information, past medical history, medication records, and laboratory and imaging examination results; The age of onset is between 18 and 75 years old, regardless of gender; The treatment plan is clearly defined as this Chinese herbal compound or flurbiprofen ester gel patch applied externally, with other combined medication regimens being consistent; Treatment course ≥ 7 days, with complete follow-up records (including efficacy assessments at least 3 days and 7 days after treatment).

[0064] Exclusion criteria (1) Patients who do not meet the inclusion criteria; (2) Patients whose medical records are missing more than 20% of key information, making it impossible to accurately assess their condition or treatment efficacy; (3) Patients with concurrent suppurative arthritis, rheumatoid arthritis, psoriatic arthritis, or other crystalline arthritis (such as calcium pyrophosphate deposition syndrome); (4) Patients who have severe joint deformities, joint destruction, skin ulceration, or infection of ruptured tophi at the time of consultation; For those with broken skin, eczema, contact dermatitis or other skin lesions at the application site; Patients with severe hepatic or renal insufficiency (ALT > 3 times the upper limit of normal, Cr > 2 times the upper limit of normal) or end-stage renal disease undergoing dialysis treatment; Those who have used systemic glucocorticoids within the past week, or those who have received intra-articular injections of glucocorticoids within the past 24 hours; Patients with serious cardiovascular and cerebrovascular events (myocardial infarction or stroke within the past 6 months), uncontrolled malignant tumors, or active gastrointestinal ulcer bleeding; Pregnant or breastfeeding women; Those with comorbid mental illness or cognitive impairment, or whose medical records are unreliable; (11) For the same patient with multiple acute attacks, only the first complete record of topical drug treatment should be included, and records of repeated attacks should be excluded; (12) Those who change the type of topical medication or add other topical preparations during treatment.

[0065] Pain assessment: VAS score, or Visual Analogue Scale for Pain: Draw a 10cm horizontal line on a piece of paper. One end of the line is 0, which means no pain; the other end is 10, which means severe pain; the middle part represents different degrees of pain.

[0066] Statistical analysis: SPSS 22.0 statistical software was used for data processing. The t-test was used to compare the means before and after treatment within the group and between the groups for continuous data. Non-parametric tests were used for categorical data. P < 0.05 was considered statistically significant.

[0067] Comparison of VAS scores between the two groups before intervention and at 1, 3 and 7 days after intervention: VAS scores of both groups were significantly reduced after intervention (P<0.05). Moreover, the observation group showed a significantly greater reduction in scores after treatment than the control group (P<0.05), indicating that the observation group significantly improved pain, and the difference was statistically significant.

[0068] Note: **P < 0.01 (n = 30).

[0069] In summary, the external Chinese medicine composition for treating damp-heat stagnation and swelling, and its preparation method, as described in this invention, demonstrate technological advancement in its construction of a rigorous engineering technology system. This system encompasses the pharmacological logic of component proportions, the process physics of ultrafine pulverization and three-dimensional mixing, and the application kinetics of different application matrices. Through precise parameter settings, such as a 9% moisture threshold, a 75μm particle size red line, a 30-minute mixing time, and excipient ratios tailored to different symptoms, this invention successfully transforms traditional experience into a replicable and quantifiable modern pharmaceutical technology solution. This not only significantly improves the clinical treatment efficiency of damp-heat stagnation and swelling but also provides a solid experimental basis and industrialization model for the standardization of external Chinese medicine treatments. Through rigorous comparison of examples and comparative examples, this invention demonstrates performance far exceeding existing technologies in key technical indicators such as swelling reduction speed, analgesia depth, and safety margin.

[0070] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A topical traditional Chinese medicine composition for treating swelling and pain caused by damp-heat and blood stasis, characterized in that, It is composed of the following raw materials in parts by weight: 2-3 parts Glauber's salt, 2-3 parts rhubarb (processed with wine), 2-3 parts gardenia, 2-3 parts processed pinellia, 2-3 parts borneol, 1-2 parts phellodendron bark, 1-2 parts atractylodes, and 1.5-2 parts raw arisaema.

2. The topical traditional Chinese medicine composition for treating swelling and pain due to damp-heat and blood stasis according to claim 1, characterized in that, In the aforementioned topical Chinese medicine composition, Glauber's salt and rhubarb (processed with alcohol) serve as the principal ingredients, constructing a synergistic physical-chemical chain. The Glauber's salt induces water to migrate to the drug layer to reduce edema by generating a physical gradient higher than the osmotic pressure of the local interstitial fluid. The rhubarb in the wine contains emodin and anthraquinone derivatives, the proportion of which is increased after the wine-processing process. These derivatives enter the dermis through lipid channels in the stratum corneum opened by borneol molecules, intervening in the inflammatory cascade reaction. The weight percentage of Arisaema heterophyllum is precisely controlled within a critical window of 1.5-2 parts to ensure that its triterpenoid saponin components operate at a balance point that has the activity of dispersing nodules and reducing swelling without causing skin burns.

3. The topical traditional Chinese medicine composition for treating swelling and pain due to damp-heat and blood stasis according to claim 1, characterized in that, The physical form of the external Chinese medicine composition is ultrafine powder, and the average particle size of the ultrafine powder is distributed between 65μm and 75μm. The specific surface area of ​​the drug particles is 4-6 times higher than that of traditional mechanically pulverized powders, which enhances the diffusion dynamics of the active pharmaceutical ingredients in the application matrix. Furthermore, the particle size of the drug particles is smaller than the average diameter of the hair follicle opening in human skin, allowing them to be tightly embedded between the skin grooves and papules.

4. The topical traditional Chinese medicine composition for treating swelling and pain due to damp-heat and blood stasis according to claim 3, characterized in that, The components in the ultrafine powder are in a highly uniform distribution state, and the coefficient of variation (CV) of the eight medicinal materials per unit volume is less than 2%. The external Chinese medicine composition eliminates the segregation phenomenon caused by the specific gravity difference between Glauber's salt and borneol at the microscopic level, ensuring that the proportions of the principal, assistant, adjuvant, and guiding components in the dressing layer per unit area are consistent with the original ratio during application.

5. A method for preparing a topical traditional Chinese medicine composition for treating swelling and pain due to damp-heat and blood stasis, applicable to the topical traditional Chinese medicine composition for treating swelling and pain due to damp-heat and blood stasis as described in any one of claims 1-4, characterized in that, The process includes the following steps: Raw material pretreatment: Glauber's salt, rhubarb, gardenia, pinellia, borneol, phellodendron bark, atractylodes, and raw arisaema are cleaned and impurities are removed. They are then placed in a drying oven for constant temperature drying, and the moisture content of each herb is controlled to be below 9%. Ultrafine grinding: The pretreated medicinal materials are mixed according to the weight ratio and fed into an air jet mill. High-speed compressed air drives the medicinal material particles to self-collision and grind them in the grinding chamber to obtain ultrafine powder with a fineness of 200 mesh and an average particle size of less than 75 μm. Three-dimensional mixing: Ultrafine powder is put into a three-dimensional mixer and continuously mixed for 30 minutes under the turbulent motion state of multi-axis linkage of the container. The differences in particle size and specific gravity between powders are eliminated by the combined motion of translation, rotation and rocking. Packaging and storage: The uniformly mixed powder is packaged into double-layer aluminum foil composite film bags in an environment with a relative humidity of less than 45% using a fully automatic dispensing machine, and then sealed to obtain the finished powder product.

6. The method for preparing a topical traditional Chinese medicine composition for treating swelling and pain due to damp-heat and blood stasis according to claim 5, characterized in that, In the raw material pretreatment, the drying temperature of the drying oven is set in the range of 55-60 degrees Celsius to prevent the large-scale sublimation and loss of camphor molecules while removing moisture. The final moisture content of the medicinal materials is controlled below the critical value of 8.5% in order to optimize the pulverization efficiency in the process by increasing the brittle modulus of the medicinal materials and to inhibit the accumulation of heat during the pulverization process that leads to hydrolysis of active monomers.

7. The method for preparing a topical traditional Chinese medicine composition for treating swelling and pain due to damp-heat and blood stasis according to claim 5, characterized in that, In the ultrafine pulverization, the airflow pulverization system uses compressed air with a self-cooling effect as a power source, and the pressure of the compressed air is constantly controlled at 0.8-1.0 MPa. By adjusting the feeding speed, it is ensured that the obtained powder particles pass through a 200-mesh sieve, and the specific surface area of ​​the obtained particles is sufficient to support the molecular diffusion of the active ingredients across the stratum corneum of the skin into the dermis.

8. A method for preparing a topical traditional Chinese medicine composition for treating swelling and pain due to damp-heat and blood stasis according to claim 5, characterized in that, In the aforementioned three-dimensional mixing, the operating parameters of the three-dimensional mixer are set as follows: Mixing speed 25-30 rpm, mixing time 30-40 minutes; The mixing process generates continuous alternating pulses, which enable the heavier Glauber's salt particles and the lighter borneol powder to achieve a microscopic level of disordered and uniform distribution in three-dimensional space, eliminating the influence of gravitational segregation on the consistency of efficacy.

9. The application of a topical traditional Chinese medicine composition for treating swelling and pain due to damp-heat and blood stasis in the preparation of a clinical poultice, characterized in that, The topical Chinese medicine composition is formulated into a paste by selecting a corresponding preparation base according to different pathological characteristics and then applied to the affected area. The preparation method and targeted strategies are as follows: The first method is to mix the powdered composition with honey at a weight ratio of 1:0.8 to 1:1.

2. This method utilizes the skin-moisturizing and tissue-regenerating activity of honey and its synergistic effect of high osmotic pressure. It is suitable for general redness, swelling and pain as well as acute attacks of gouty arthritis. The second method is to mix the powdered composition with vinegar at a weight ratio of 1:0.8 to 1:1.

2. Acetic acid is used to promote the dissolution of alkaloids and enhance the ability to promote blood circulation and remove blood stasis. This method is suitable for local blood stasis and hard nodules that do not dissipate after bruises and sprains. The third method is to mix the powdered composition with strong tea at a weight ratio of 1:0.8 to 1:1.

2. The astringent effect of tea polyphenols works synergistically with the components in the formula to clear heat and detoxify. This method is suitable for the acute phase of sores and carbuncles, the early stage of herpes zoster, or infectious skin diseases with obvious heat and toxicity. The fourth method is egg white application: the powdered composition is mixed with egg white at a weight ratio of 1:0.8 to 1:1.

2. The physical encapsulation and buffering properties of egg white are used to make it suitable for patients with sensitive skin or allergies. When applying the paste, the thickness of the dressing layer should be maintained at 2-3 mm to establish a constant drug diffusion concentration gradient and prevent the drug from clumping due to excessive moisture evaporation.

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