External traditional Chinese medicine composition for relieving swelling and pain as well as preparation method and application of external traditional Chinese medicine composition

Abstract

The invention discloses an external traditional Chinese medicine composition for relieving swelling and pain as well as a preparation method and application thereof, and particularly relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises a traditional Chinese medicine extract and common medicinal auxiliary materials, and traditional Chinese medicines comprise caulis clematidis armandii, beefwood-like clubmoss herb, rhizoma acori graminei, lignum dalbergiae odoriferae, rhizoma curcumae longae Rhizoma curcumae longae and lignum dalbergiae odoriferae are used as monarch drugs for promoting Beefwood-like clubmoss herb and caulis clematidis armandii are used as ministerial drugs Rhizoma acori graminei and herba asari are used as assistants and guides to open All the medicines are combined to achieve the effects of promoting blood circulation to remove blood stasis, relaxing tendons and dredging collaterals and relieving swelling and pain. The medicine for promoting blood circulation to remove blood stasis is used for treating the root (blood stasis), the medicine for inducing diuresis to relax tendons is used for treating the symptoms (edema and contracture), and a powerful transdermal agent is matched to ensure that the efficacy is achieved.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a topical traditional Chinese medicine composition for reducing swelling and relieving pain, its preparation method, and its application. Background Technology

[0002] Sciatica, frozen shoulder (adhesive capsulitis), tenosynovitis, and degenerative diseases such as osteoarthritis and lumbar disc herniation are common painful and functional disorders in clinical practice. Their core pathogenesis largely corresponds to the concept of "Bi syndrome" in Traditional Chinese Medicine (TCM), which involves the obstruction of meridians by pathogenic factors such as wind, cold, dampness, and blood stasis, leading to poor circulation of Qi and blood, manifesting as pain, numbness, swelling, and limited mobility. With the increasing aging population and changes in modern lifestyles, the incidence of these diseases continues to rise, creating an urgent need for highly effective, safe, and comprehensive treatment options.

[0003] Chinese patent CN101336993A discloses a topical tincture for treating rheumatic pain and acute sprains and contusions. The tincture uses ethanol to extract seven medicinal herbs from the formula: cinnabar root, *Caulis Atractylodes macrocephala*, *Periploca sepium*, *Zanthoxylum nitidum*, *Herba Lysimachiae*, *Polygonum cuspidatum*, and *Caulis Schisandrae*, along with camphor and borneol. However, this single ethanol extraction method results in incomplete extraction of the active ingredients from the raw materials, affecting both raw material utilization and product yield.

[0004] Chinese patent CN118994267A discloses an effective method for extracting chemical components from Aristolochia debilis (using a single ethanol ultrasonic extraction mode), but without special treatment of the volatile oil, resulting in the volatile oil escaping with solvent vapor or being destroyed by high temperature during the extraction process.

[0005] Chinese patent CN101886029A, a method and apparatus for accelerating the production process of medicinal wine using ultrasound, only uses ultrasound assistance without combining the advantages of microwave technology in enhancing the dissolution of polar components, and it is not connected with the pre-extraction process of volatile oils, thus failing to meet the extraction needs of different types of components.

[0006] Therefore, how to fully retain the effective components in raw materials, achieve high resource utilization, and improve process synergy are urgent problems to be solved. Summary of the Invention

[0007] Therefore, the present invention provides a topical traditional Chinese medicine composition for reducing swelling and relieving pain, its preparation method and application, in order to solve the above-mentioned problems.

[0008] To achieve the above objectives, the present invention provides the following technical solution: According to one aspect of the present invention, a topical Chinese medicine composition for reducing swelling and relieving pain is provided, the Chinese medicine composition comprising Chinese herbal extracts and commonly used pharmaceutical excipients, wherein the Chinese herbs include Akebia trifoliata, Sophora flavescens, Acorus tatarinowii, Dalbergia odorifera, Curcuma longa and Asarum heterotropoides.

[0009] Furthermore, the preparation method of the traditional Chinese medicine extract includes: Step 1: Extraction of volatile oils The volatile oils of three herbs rich in volatile oils—Acorus tatarinowii, Dalbergia odorifera, and Asarum heterotropoides—were extracted separately using steam distillation, and the residue was collected separately. Step 2, alcohol extraction After mixing the dregs from step one with Aristolochia debilis, Gynostemma pentaphyllum, and Curcuma longa, add an ethanol solution and use ultrasound-assisted low-temperature dynamic extraction to obtain an ethanol extract. Step 3, Mix The ethanol extract was slowly added to the volatile oil obtained in the first step under stirring, and a small amount of solubilizer was used to help the volatile oil to be evenly and stably dispersed in the alcohol. After magnetization, the herbal extract was obtained.

[0010] This invention employs steam distillation first, which avoids losses due to thermal effects during subsequent alcohol extraction, ensuring that the core aromatic and permeation-enhancing components are fully preserved.

[0011] Furthermore, in step two, the concentration of the ethanol solution is 50-60%, and the material-to-liquid ratio is 1:8-12 (medicinal material: ethanol).

[0012] Furthermore, in step two, the parameters for ultrasound-assisted low-temperature dynamic extraction include: an ultrasound frequency of 20-40 kHz, an ultrasound power density of 0.3-0.5 W / mL, a temperature control of 40-50℃, and a extraction speed of 30-60 rpm. Ultrasound can generate a cavitation effect, mechanically disrupting the cell wall and significantly increasing the dissolution rate of poorly soluble components such as curcumin, resulting in shorter extraction time and higher efficiency.

[0013] Furthermore, in step three, the amount of solubilizer used is 5-30%.

[0014] Furthermore, in step three, the stirring speed is 300-500 rpm and the mixing temperature is 30-40℃.

[0015] Furthermore, in step three, the magnetization conditions are: a magnetic flux of 900-1100 Gauss. Under a magnetic field strength of 0.09-0.11 T, the mixture is circulated at a flow rate of 0.5-1.5 m / s for 10-30 minutes.

[0016] This invention employs magnetization treatment, which can activate molecules, making the molecular arrangement of components in the liquid medicine more orderly and enhancing their activity; it can also change the physical properties of the liquid medicine, enhancing its skin penetration ability; and making the system more stable.

[0017] Furthermore, in step three, the mixture also includes a filtration step: filtering with a 0.45-micron filter membrane to obtain a clear medicinal solution.

[0018] Furthermore, the dosage of each component in the Chinese medicine is as follows: 5-15 parts of Akebia trifoliata, 5-15 parts of Sophora flavescens, 3-8 parts of Acorus tatarinowii, 3-8 parts of Dalbergia odorifera, 1-5 parts of Curcuma longa and 1-5 parts of Asarum heterotropoides.

[0019] Furthermore, the content of the herbal extract is 20-40%.

[0020] According to another aspect of the present invention, a topical Chinese medicine composition for reducing swelling and relieving pain is used in the preparation of a treatment for painful and functional disorders.

[0021] Akebia trifoliata: promotes diuresis and eliminates dampness, regulates menstruation and promotes lactation. In this formula, its main function is to promote diuresis and reduce swelling, facilitating the metabolism of excess fluid in tissues through its diuretic effect, thereby eliminating swelling. At the same time, its effect of "regulating menstruation" helps to unblock the meridians.

[0022] Muscle-relaxing herb (usually referring to *Lycopodium clavatum*): dispels wind and dampness, relaxes muscles and tendons. For "functional disorders," its main effects are to relieve contractures, relax muscles and tendons, and improve joint stiffness and limited range of motion caused by trauma or rheumatism.

[0023] Acorus tatarinowii: It opens the orifices, clears phlegm, resolves dampness, and harmonizes the stomach. For external use, it is valued for its aromatic and penetrating properties, which help open joints. Its rich volatile oils can penetrate the skin, promoting blood circulation, clearing the meridians, and relieving pain; these are important guiding and penetration-enhancing components.

[0024] Fragrance: It can resolve blood stasis, stop bleeding, regulate qi, and relieve pain. This product is pungent and warm, which can not only promote blood circulation and remove blood stasis to reduce swelling and relieve pain, but also promote qi circulation to help blood flow. It is effective for swelling and pain caused by traumatic injuries and qi and blood stasis.

[0025] Turmeric: It promotes blood circulation, regulates qi, and relieves pain. It is a recognized potent natural anti-inflammatory and analgesic by modern research (its main active ingredient is curcumin). Its strong blood-activating properties allow it to penetrate deep into the bloodstream, making it highly effective for pain caused by blood stasis. It is a key analgesic in traditional Chinese medicine formulas.

[0026] Asarum: dispels wind and cold, clears the orifices and relieves pain. Its pungent and penetrating properties are extremely strong, giving it excellent local anesthetic, analgesic, and anti-inflammatory effects. When used externally, it can warm and unblock the meridians, dispel cold and dampness, and act as a "guide drug" to significantly enhance the transdermal absorption of other drug components.

[0027] Aristolochia debilis + Herba Lysimachiae: Focuses on reducing edema and relaxing muscles and tendons, treating "swelling" and "functional disorders".

[0028] Fragrance + Turmeric: Focuses on promoting blood circulation, removing blood stasis and relieving pain, treating "pain" and "blood stasis".

[0029] Acorus tatarinowii + Asarum heterotropoides: As an aromatic transdermal combination, it utilizes volatile oils to open the orifices and unblock the meridians, while guiding the medicinal components directly to the affected area and enhancing the local analgesic effect.

[0030] The present invention has the following advantages: In this invention, turmeric and sandalwood are the principal herbs, promoting blood circulation and relieving pain; *Smilax glabra* and *Akebia trifoliata* are the assistant herbs, relaxing muscles and reducing swelling; *Acorus tatarinowii* and *Asarum heterotropoides* are the adjuvant herbs, clearing the orifices and guiding the medicine through the meridians. The combined effects of these herbs promote blood circulation, remove blood stasis, relax muscles and tendons, and reduce swelling and pain. It treats the root cause (blood stasis) with blood-activating and stasis-removing herbs, addresses the symptoms (edema and contracture) with diuretic and muscle-relaxing herbs, and incorporates a potent transdermal agent to ensure effective drug delivery.

[0031] This invention employs a stepwise extraction method, avoiding the loss of volatile oils caused by subsequent alcohol heating, and ensuring that key aromatic, diaphoretic, and analgesic transdermal components are collected individually and completely. This invention uses ultrasound-assisted low-temperature dynamic extraction on the residue and other medicinal materials, utilizing cavitation effects to disrupt cell walls, which can significantly improve the dissolution rate and extraction efficiency of active ingredients; low temperature can effectively prevent the destruction of heat-sensitive components (such as some terpenes and phenols). Detailed Implementation

[0032] The following specific embodiments illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0033] Aristolochic acid: Tested before use to ensure it does not contain aristolochic acid, preventing contamination by Aristolochia manshuriensis.

[0034] pH adjusters include, but are not limited to, 0.1M sodium hydroxide and citric acid / sodium citrate.

[0035] Example 1 This embodiment provides a topical Chinese medicine spray for reducing swelling and relieving pain: Chinese herbs: 15 parts of Akebia trifoliata, 15 parts of Sophora flavescens, 8 parts of Acorus tatarinowii, 8 parts of Dalbergia odorifera, 5 parts of Curcuma longa and 5 parts of Asarum heterotropoides.

[0036] Extraction methods of traditional Chinese medicine: Step 1: Extraction of volatile oils Crush Acorus tatarinowii, Dalbergia odorifera, and Asarum heterotropoides to a particle size of approximately 2-5 mm. Mix the crushed Acorus tatarinowii, Dalbergia odorifera, and Asarum heterotropoides thoroughly and place them in a flask of a steam distillation apparatus. Add an appropriate amount of distilled water (6-8 times the amount of the medicinal materials) to the apparatus and connect the condenser. Continue distilling for 2-4 hours, or until the distillate is no longer cloudy and the oil droplets no longer increase significantly. Collect the upper oil-water mixture (i.e., the distillate, rich in volatile oil) through a separatory funnel, seal it, and store it at a low temperature (4-10℃) away from light for later use. Retain the lower layer of water-containing residue for later use.

[0037] Step 2, alcohol extraction After mixing the water-containing medicinal residue from step one with Aristolochia debilis, Sophora flavescens, and Curcuma longa, add 60% ethanol solution. The material-to-liquid ratio is 1:8 (weight of medicinal material: volume of ethanol solution). Extraction is carried out using an ultrasonic-assisted low-temperature dynamic extraction method. Coarse filtration is performed using a 100-200 mesh filter cloth to separate the ethanol extract. Ultrasonic-assisted low-temperature dynamic extraction parameters: ultrasonic frequency 28kHz, power density 0.4W / mL, temperature 45℃, stirring speed 45rpm; Step 3, Mix The alcohol extract was slowly added to the volatile oil obtained in the first step under stirring (450 rpm), and 10% Tween-80 was used as a solubilizer to help the volatile oil be evenly and stably dispersed in the alcohol. After magnetization, the traditional Chinese medicine extract was obtained.

[0038] Magnetization conditions: The mixture is pumped into the magnetization processor with a magnetic flux of 1000 Gauss. In a static or dynamic magnetic field with a magnetic field strength of 0.1 Tesla (T), the medicine is circulated at a flow rate of 1.0 m / s for 20 minutes to obtain the Chinese medicine extract.

[0039] External application of traditional Chinese medicine spray: 30% traditional Chinese medicine extract, 15% ethanol, 1% azone (laurocapram), 5% glycerin, 0.1% EDTA-2Na, adjust pH to 6.5 with 0.1M sodium hydroxide, and add water to 100%.

[0040] Preparation method: First, EDTA-2Na is dissolved in water to obtain an aqueous solution; the herbal extract, ethanol, glycerol, and azone are mixed and stirred at 300 rpm for 10-15 minutes at room temperature to ensure thorough mixing, thus obtaining an alcoholic solution; the aqueous solution and alcoholic solution are mixed evenly, and 0.1M sodium hydroxide is added to adjust the pH to 6.5. The mixture is then sealed and allowed to stand for at least 24 hours to promote the precipitation of any possible minor impurities and the maturation of the system. Subsequently, a 0.22μm microporous membrane is used for terminal filtration sterilization to obtain a clear and stable herbal spray.

[0041] Example 2 This embodiment provides a topical Chinese medicine spray for reducing swelling and relieving pain: The amount of Chinese herbal extract added was 20%, ethanol 20%, azone 1.5%, glycerol 3%, EDTA-2Na 0.1%, and 0.1M sodium hydroxide was used to adjust the pH to 6.5. Water was added to 100%, and everything else was completely consistent with Example 1.

[0042] Example 3 This embodiment provides a topical Chinese medicine spray for reducing swelling and relieving pain: The amount of Chinese herbal extract added was 40%, ethanol 10%, azone 2%, glycerol 5%, EDTA-2Na 0.1%, and 0.1M sodium hydroxide was added to adjust the pH to 6.5. Water was added to 100%, and everything else was completely consistent with Example 1.

[0043] Example 4 This embodiment provides a topical Chinese medicine spray for reducing swelling and relieving pain: Chinese herbs: 5 parts of Akebia trifoliata, 10 parts of Sophora flavescens, 3 parts of Acorus tatarinowii, 8 parts of Dalbergia odorifera, 5 parts of Curcuma longa and 1 part of Asarum heterotropoides.

[0044] Everything else is completely consistent with Example 1.

[0045] Example 5 This embodiment provides a topical Chinese medicine spray for reducing swelling and relieving pain: Chinese herbs: 10 parts of Akebia trifoliata, 5 parts of Sophora flavescens, 5 parts of Acorus tatarinowii, 5 parts of Dalbergia odorifera, 3 parts of Curcuma longa and 1 part of Asarum heterotropoides.

[0046] Everything else is completely consistent with Example 1.

[0047] Example 6 This embodiment provides a topical ointment for reducing swelling and relieving pain: The herbal extract prepared in Example 1 was added to melted petrolatum (the amount of petrolatum added was twice that of the herbal extract) and stirred until it became a paste.

[0048] Comparative Example 1 This comparative example provides a topical Chinese medicine spray for reducing swelling and relieving pain: In the preparation method of the herbal extract in Example 1, step two, alcohol extraction, involves mixing the herbal residue with Aristolochia debilis, Clematis armandii, and Curcuma longa, then adding a 60% ethanol solution (the ratio of herbal weight to ethanol solution volume is 1:10). The mixture is sealed and soaked at room temperature (20-25℃) for 5 days with intermittent stirring. After soaking, the mixture is coarsely filtered through a 100-200 mesh filter cloth to obtain the alcohol extract. All other steps are identical to those in Example 1.

[0049] Comparative Example 2 This comparative example provides a topical Chinese medicine spray for reducing swelling and relieving pain: Without extracting volatile oils, all the Chinese herbal raw materials were directly mixed and subjected to the alcohol extraction method of Example 1.

[0050] Everything else is completely consistent with Example 1.

[0051] Comparative Example 3 This comparative example provides a topical Chinese medicine spray for reducing swelling and relieving pain: Without magnetization, everything else is exactly the same as in Example 1.

[0052] Comparative Example 4 This comparative example provides a topical Chinese medicine spray for reducing swelling and relieving pain: The herbs *Shujincao* and *Chuanmutong* were replaced with equal amounts of *Shenjincao* and *Tongcao*, otherwise it was completely consistent with Example 1.

[0053] Comparative Example 5 This comparative example provides a topical Chinese medicine spray for reducing swelling and relieving pain: Turmeric and sandalwood were replaced with equal amounts of turmeric and sandalwood, otherwise it was completely consistent with Example 1.

[0054] Comparative Example 6 This comparative example provides a topical Chinese medicine spray for reducing swelling and relieving pain: The Acorus tatarinowii and Asarum were replaced with equal amounts of Polygala tenuifolia and Angelica dahurica, and everything else was exactly the same as in Example 1.

[0055] Comparative Example 7 Yunnan Herbals, Bai Cui Lai Safflower and Drynaria Rhizome Joint Spray, purchased from Taobao.

[0056] Experimental Example 1 Example 1 and Comparative Examples 1-7: Experiment on paw joint swelling in rats with arthritis treated with topical Chinese medicine spray: 1. Dissolve bovine type II collagen in 0.1 mol / L acetic acid to a concentration of 10 mg / mL, stir at 4°C until fully dissolved, and let stand at 4°C overnight. Heat autoclaved liquid paraffin to 70°C, add inactivated attenuated BCG vaccine to the liquid paraffin to a concentration of 10 mg / mL, and grind thoroughly until completely dissolved to serve as a complete adjuvant.

[0057] 2. Experimental animals: Male Wistar rats (purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd.), weighing 100±10g, 80 rats, were randomly divided into blank group, model group, Example 1 group, comparative example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group, comparative example 5 group, comparative example 6 group, and comparative example 7 group, with 8 animals in each group.

[0058] 3. The joint volume of the left hind paw of all rats was determined using the water volume method and recorded as the pre-inflammatory volume.

[0059] Emulsify a 10 mg / mL bovine type II collagen acetate solution with an equal volume of complete adjuvant to obtain a suspension. Intradermal injection of the suspension into the right hind paw pad of rats in the model group, Example 1 group, and Comparative Examples 1-7 groups was performed, with an injection volume of 0.1 mL. Seven days later, a booster injection was given at the base of the tail of the rats. The blank group was injected with 0.1 mL of autoclaved liquid paraffin.

[0060] Four hours after bovine type II collagen injection, the herbal spray prepared in Example 1 and Comparative Examples 1-7 was sprayed onto the right hind paw and joint of rats. The model group was fed with physiological saline, while the control group was fed normally. Spraying was performed three times daily for five consecutive weeks. Before spraying on days 7, 21, and 35, the water volume of the right hind paw joint was measured using the water volume method. The swelling rate (%) of the left hind paw joint and the swelling inhibition rate of the rat paw joint were calculated. During the experiment, if any animal showed significant model failure (e.g., extremely low joint swelling rate or severe abnormalities), it was excluded and not included in the final statistical analysis. Data analysis was performed using the multivariate ANOVA module of SPSS statistical software. P < 0.05 indicated statistical significance. Specific experimental results are shown in Table 1. Swelling rate of left hind paw joint in rats (%) = (post-inflammatory joint volume - pre-inflammatory joint volume) / pre-inflammatory joint volume × 100%; Rat paw joint swelling inhibition rate (%) = (model group paw joint volume - experimental group paw joint volume) / model group paw joint volume × 100%.

[0061] Table 1 As shown in Table 1, Example 1 exhibited the highest swelling inhibition rate at all three time points, especially approaching 50% in the chronic phase (day 35), significantly superior to other groups. This indicates that the complete preparation process of Example 1 (pre-extraction of volatile oil, ultrasonic extraction, and magnetization) and the original formula produced a synergistic effect, effectively controlling acute inflammation and inhibiting chronic joint swelling. The inhibition rate of Comparative Example 1 (soaking extraction) was significantly lower than that of Example 1 (ultrasonic extraction) at all time points, confirming the advantages of ultrasonic-assisted low-temperature dynamic extraction in terms of efficiency and preservation of heat-sensitive components. The effect of Comparative Example 2 (without volatile oil extraction) decreased significantly, indicating that the step of pre-extracting volatile oil is crucial for preserving the anti-inflammatory and analgesic active ingredients in Acorus tatarinowii, Dalbergia odorifera, and Asarum heterotropoides. Although the effect of Comparative Example 3 (without magnetization) was better than most comparative examples, it was still inferior to Example 1, indicating that magnetization may have a certain enhancing effect on efficacy by affecting the physical properties of the medicinal solution or promoting component dispersion. Comparative Example 4 (replacing *Shujincao* / *Chuanmutong*) and Comparative Example 5 (replacing *Jianghuang* / *Jiangxiang*) showed significantly reduced effects, indicating that the combination of *Shujincao* and *Chuanmutong* for dispelling wind and dampness, clearing the meridians and relieving pain, and the combination of *Jianghuang* and *Jiangxiang* for promoting blood circulation, regulating qi, reducing swelling and relieving pain, are the core of the original formula. Comparative Example 6 (replacing *Shichangpu* / *Xixin*) showed the worst effect, highlighting the irreplaceable key effects of *Shichangpu* (opening the orifices and resolving phlegm) and *Xixin* (dispelling wind, dispersing cold and relieving pain) in the formula for clearing the orifices and relieving pain. Comparative Example 7 (commercially available product) showed some effect, but the inhibition rate at all time points was consistently and significantly lower than that of Example 1, which, from an animal experiment perspective, demonstrates the competitive advantage of the product of this invention in reducing swelling. The inhibition rate of the Example 1 group was the highest on day 35, further indicating that the herbal spray of this invention has a more prominent effect in long-term treatment and may be more suitable for the management of chronic arthritis.

[0062] Experimental Example 2 Acetic acid-induced writhing analgesia in mice: Eighty SPF-grade Kunming mice (weighing 18–22 g), half male and half female, were randomly divided into 10 groups: a treatment group (Examples 1 and Comparative Examples 1–7), a model group, and a control group. The abdominal hair of the mice in the treatment and model groups was removed, covering an area of ​​approximately 1.5 cm × 1.5 cm. The corresponding medication was applied to the hairless area of ​​each group at a volume of 0.25 mL, twice daily for 5 consecutive days. The treatment group received a spray of the traditional Chinese medicine obtained in Examples 1 and Comparative Examples 1–7, while the model group received an equal volume of physiological saline. The control group received no treatment. Thirty minutes after the last administration, each mouse was intraperitoneally injected with 0.1 mL / 10 g of 0.6% acetic acid solution. The time (pain threshold) and frequency of the first writhing response (abdomen concavity, hind limb extension, and hip elevation) within 15 minutes of the pain-inducing agent injection were recorded (Table 2).

[0063] Inhibition rate of writhing count (%) = (mean writhing count in the model group - mean writhing count in the drug intervention group) / mean writhing count in the model group × 100%.

[0064] Experimental data were analyzed using SPSS 26.0 statistical software. Pain threshold, number of writhing episodes, and writhing inhibition rate are expressed as mean ± standard deviation. P < 0.05 indicates statistical significance.

[0065] Table 2 As shown in Table 2, Example 1 exhibited the best analgesic effect, with the highest pain threshold, the fewest number of writhing episodes, and an inhibition rate of nearly 60%. This fully demonstrates the synergistic advantages of the complete process and original formula in analgesia. Comparative Example 1 (soaking extraction) showed significantly worse results than Example 1 in all indicators, confirming that ultrasound-assisted low-temperature dynamic extraction can more effectively extract analgesic active ingredients. Comparative Example 2 (without separate extraction of volatile oils) showed a significant decrease in effect, indicating that the volatile oil components in Asarum, Acorus tatarinowii, and Dalbergia odorifera are crucial for peripheral analgesia. Comparative Example 3 (without magnetization) was second only to Example 1 in effect, but still showed a gap, suggesting that magnetization treatment may have a clear enhancement of analgesic effect by promoting transdermal drug delivery or component stability. Comparative Example 4 (replacing Clematis armandii / Akebia trifoliata) and Comparative Example 5 (replacing Curcuma longa / Dalbergia odorifera) also showed poor results, confirming that the combination of dispelling wind and unblocking collaterals with promoting blood circulation and qi flow in the original formula is indispensable for relieving painful spasms. Comparative Example 6 (replacing Acorus tatarinowii / Asarum heterotropoides) showed the weakest effect, indicating that the combination of these two herbs plays a core role in the formula in terms of dispelling cold, clearing the orifices, and relieving pain. Comparative Example 7 (commercially available product) showed a moderate analgesic effect (inhibition rate of 53.8%), but all indicators were significantly inferior to Example 1, which directly proves the analgesic efficacy advantage of the product of this invention.

[0066] Subsequent routine rabbit skin irritation tests showed that the topical Chinese medicine spray prepared in Example 1 of this invention was non-irritating to both intact and broken skin, and no allergic reactions were observed, thus proving the safety of the product of this invention.

[0067] Although the present invention has been described in detail above with general descriptions and specific embodiments, modifications or improvements can be made to it, which will be obvious to those skilled in the art. Therefore, all such modifications or improvements made without departing from the spirit of the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for reducing swelling and relieving pain for external use, characterized in that, The traditional Chinese medicine composition comprises a traditional Chinese medicine extract and a pharmaceutical common excipient, wherein the traditional Chinese medicine comprises Caulis Clematidis Armandii, Herba Lycopodii, Rhizoma Acori Tatarinowii, Lignum Dalbergiae Odoriferae, Curcuma Longa and Herba Linderae.

2. The external use traditional Chinese medicine composition for swelling and pain relief according to claim 1, characterized in that, The preparation method of the traditional Chinese medicine extract comprises: Step one, extraction of volatile oil Rhizoma Acori Tatarinowii, Lignum Dalbergiae Odoriferae and Herba Linderae are separately extracted by steam distillation, and the residues are separately collected; Step two, alcohol extraction The residues in step one are mixed with Caulis Clematidis Armandii, Herba Lycopodii and Curcuma Longa, and then ethanol solution is added, and the residues are extracted by ultrasonic-assisted low-temperature dynamic extraction to obtain alcohol extract; Step three, mixing The alcohol extract is slowly added to the volatile oil obtained in the first step under stirring, and a small amount of solubilizer is used to help the volatile oil uniformly and stably disperse in the alcohol extract, and then the traditional Chinese medicine extract is obtained after magnetization.

3. The external use traditional Chinese medicine composition for swelling and pain relief according to claim 2, characterized in that, In step two, the concentration of the ethanol solution is 50-60%, and the solid-liquid ratio is 1:8-12.

4. The external use traditional Chinese medicine composition for swelling and pain relief according to claim 2, characterized in that, In step two, the parameters of ultrasonic-assisted low-temperature dynamic extraction include: ultrasonic frequency of 20-40 kHz, ultrasonic power density of 0.3-0.5 W / mL; temperature control at 40-50℃; speed of 30-60 rpm.

5. The external use traditional Chinese medicine composition for swelling and pain relief according to claim 2, characterized in that, In step three, the amount of solubilizer used is 5-30%.

6. The external use traditional Chinese medicine composition for swelling and pain relief according to claim 2, characterized in that, In step three, the stirring speed is 300-500 rpm, and the mixing temperature is 30-40℃.

7. The external use traditional Chinese medicine composition for swelling and pain relief according to claim 2, characterized in that, In step three, the magnetization condition is: magnetic flux of 900-1100 Gauss.

8. The external use traditional Chinese medicine composition for swelling and pain relief according to claim 1, characterized in that, The amount of each component in the traditional Chinese medicine is 5-15 parts of Caulis Clematidis Armandii, 5-15 parts of Herba Lycopodii, 3-8 parts of Rhizoma Acori Tatarinowii, 3-8 parts of Lignum Dalbergiae Odoriferae, 1-5 parts of Curcuma Longa and 1-5 parts of Herba Linderae.

9. The external use traditional Chinese medicine composition for swelling and pain relief according to claim 1, characterized in that, The content of the traditional Chinese medicine extract is 20-40%.

10. Use of a traditional Chinese medicine composition for external use for swelling and pain in the preparation of a medicament for treating painful and dysfunctional diseases.

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