Traditional Chinese medicine preparation for massage as well as preparation method and application of traditional Chinese medicine preparation

Abstract

The invention relates to the technical field of massage agentia, in particular to a traditional Chinese medicine agentia for massage and a preparation method and application thereof. The traditional Chinese medicine agentia is an external traditional Chinese medicine preparation composed of traditional Chinese medicine fluid extract prepared from the traditional Chinese medicine composition and a base matrix; wherein the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 8-12 parts of peach kernels, 8-12 parts of safflower, 6-10 parts of honeysuckle stems, 6-10 parts of loofah sponge, 8-12 parts of curcuma zedoary, 8-12 parts of rhizoma sparganii, 5-8 parts of ligusticum, 3-5 parts of fermented soybean, 5-8 parts of cortex acanthopanacis, 4-6 parts of fructus psoraleae, 4-6 parts of rhizoma dioscoreae nipponicae and 5-8 parts of hematoxylon. The traditional Chinese medicine composition for massage provided by the invention can be matched with a unique external treatment method formed by a paste massage therapy, is used for treating various orthopedics and traumatology diseases, such as various acute and chronic soft tissue injuries, stiff neck, cervical spondylosis, scapulohumeral periarthritis, lumbar disc herniation, osteoarthritis, spinal facet joint disorder, tenosynovitis and the like, has a particularly remarkable curative effect on knee osteoarthritis, and is free of toxic and side effects. The massage cream is obviously superior to common massage cream.

Description

Technical Field

[0001] This invention belongs to the field of massage medicine technology, specifically relating to a traditional Chinese medicine preparation for massage, its preparation method, and its application. Background Technology

[0002] Tuina, also known as massage, is a physical therapy method based on the fundamental theories of Traditional Chinese Medicine (especially the theories of meridians, internal organs, and qi and blood). It utilizes specific techniques applied to specific areas (acupoints, meridians, muscles, and joints) on the body's surface to prevent and treat diseases and promote health. Its core principles lie in adjusting yin and yang, unblocking meridians, promoting qi and blood circulation, restoring muscle balance, and lubricating joints. Its main mechanisms of action (based on TCM theory) are: ① Unblocking meridians: Meridians are the channels for the flow of qi and blood. Manual stimulation can activate qi, eliminate meridian blockages, and ensure smooth flow of qi and blood. "Where there is free flow, there is no pain," thus relieving symptoms such as pain and numbness caused by blocked meridians. ② Promoting qi and blood circulation: Manual techniques can promote the flow of qi and blood locally and throughout the body, improve blood circulation, increase blood flow, accelerate the removal of metabolic waste, and promote tissue repair. ③ Relieve muscle tension, spasms, and pain: Targeting muscle tension, spasms, adhesions, and strain, specific techniques (such as kneading, pressing, plucking, and pinching) are used to directly act on soft tissues, loosening adhesions, relieving muscle spasms, and eliminating pain trigger points. ④ Muscle and tendon restoration: Using techniques to adjust and straighten the anatomical positions of soft tissues (tendons, ligaments, fascia) caused by injury or strain (such as minor misalignments or tendon displacement), restoring their normal structure and tension. ⑤ Joint lubrication: Through passive or assisted joint movement techniques (such as rocking and manipulating), joint mobility is improved, joint capsule adhesions are loosened, synovial fluid secretion is increased, and normal joint function is restored. ⑥ Regulate organ function: By stimulating specific acupoints and meridians on the body surface, the functional activities of corresponding organs are affected (such as pressing Zusanli to strengthen the spleen and stomach, and massaging the back acupoints to regulate the organs).

[0003] Ointment-massage therapy is a unique external treatment method that organically combines traditional Chinese medicine ointments (or powders, oils) with massage techniques. Ointment-massage therapy achieves a synergistic effect between the medication and the massage: Dual Mechanism of Action: This is the core advantage of ointment-massage. Massage techniques themselves have the effects of unblocking meridians, promoting blood circulation, relaxing muscles and tendons, and lubricating joints. Meanwhile, the effective components of the medication, aided by the physical stimulation generated by the massage (friction generating heat, increasing osmotic pressure, and promoting local blood flow), are more easily able to penetrate the skin barrier (stratum corneum) and enter the body, directly reaching the affected area. Synergistic Effect: The massage promotes the absorption and penetration of the medication; the medication enhances the effects of the massage in promoting blood circulation, removing blood stasis, reducing swelling and relieving pain, and warming the meridians. The two complement each other, and the therapeutic effect is usually superior to simple massage or simple topical medication.

[0004] Therefore, modern Traditional Chinese Medicine (TCM) commonly uses plaster massage therapy to treat various clinical conditions, such as: orthopedic diseases: various acute and chronic soft tissue injuries (e.g., sprains, muscle strain, fasciitis), stiff neck, cervical spondylosis, frozen shoulder, lumbar disc herniation (remission period), osteoarthritis, spinal facet joint disorders, tenosynovitis, etc.; internal medicine diseases: functional gastrointestinal disorders (e.g., stomach pain, constipation, diarrhea), headache, insomnia, colds, certain types of hypertension (requiring syndrome differentiation); pediatric diseases: infantile malnutrition, diarrhea, bedwetting, infantile muscular torticollis, infantile fever, cough (e.g., pediatric massage); rehabilitation: post-stroke sequelae limb dysfunction, rehabilitation after peripheral nerve injury, rehabilitation after fracture joint stiffness, etc.

[0005] The existing Chinese medicine preparations used in plaster therapy still cannot fully demonstrate their synergistic effect for some specific injuries and diseases. Therefore, it is still necessary to develop some Chinese medicine preparations for specific clinical diseases so that they can be applied to plaster therapy to exert their synergistic effects. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine preparation for massage, its preparation method, and its application.

[0007] Specifically, the first aspect of the present invention provides a traditional Chinese medicine composition for massage, which is composed of the following medicinal materials in parts by weight: peach kernel, safflower, honeysuckle vine, loofah sponge, turmeric, sparganium, ligusticum, fermented soybean, eleutherococcus senticosus, psoralea corylifolia, smilax china, and sappanwood.

[0008] The massage-grade traditional Chinese medicine composition provided by this invention can be used in conjunction with plaster massage therapy to form a unique external treatment method for treating various orthopedic diseases, such as various acute and chronic soft tissue injuries (e.g., sprains, muscle strain, fasciitis), stiff neck, cervical spondylosis, frozen shoulder, lumbar disc herniation (remission period), osteoarthritis, spinal facet joint disorders, tenosynovitis, etc. This massage-grade traditional Chinese medicine composition, combined with plaster massage therapy, is particularly effective for knee osteoarthritis, significantly superior to ordinary massage plasters. The following is a detailed explanation of the treatment principles and traditional Chinese medicine compatibility theory of the massage-grade traditional Chinese medicine composition provided by this invention in the treatment of knee osteoarthritis and similar diseases: Traditional Chinese medicine (TCM) does not have a specific disease name for knee osteoarthritis. Therefore, in modern clinical practice, osteoarthritis is considered the TCM term for bone bi syndrome, and treatment for bone bi syndrome primarily involves formulas that promote blood circulation, remove blood stasis, and dredge the meridians. The *Huangdi Neijing* (Yellow Emperor's Inner Classic) attributes the etiology of bone bi syndrome to wind, cold, and dampness, with the disease location in the tendons and bones, and the root cause in the liver and kidneys. *Zhangshi Yitong - Zhutong Men* (Zhang's Medical Treatise - Chapter on Pain) states: "The knee is the residence of the tendons; if it cannot bend and straighten, walking requires bending and stooping, and the tendons will become exhausted. Therefore, knee pain is invariably caused by liver and kidney deficiency, and when this deficiency occurs, wind, cold, and dampness invade." This further identifies liver and kidney deficiency as the root cause of knee bi syndrome, with wind, cold, and dampness as the superficial manifestation. Therefore, this invention, based on the classic treatment principles of bone bi syndrome, incorporates auxiliary treatment principles such as dispelling wind and dredging the meridians, dispersing external pathogens, warming the kidneys and tonifying yang, and dispelling wind and strengthening the tendons, forming the following TCM formula. This formula fully utilizes the principles of syndrome differentiation and treatment in TCM, while the various components exhibit significant synergistic effects.

[0009] The traditional Chinese medicine composition provided by this invention uses peach kernel and safflower as the principal herbs, which work together to promote blood circulation and remove blood stasis; honeysuckle vine and loofah sponge are the assistant herbs, wherein honeysuckle vine clears heat and detoxifies, dispels wind and unblocks the meridians, and loofah sponge dispels wind, unblocks the meridians, promotes blood circulation and detoxifies, and the two work together to achieve the effect of unblocking the meridians and detoxifying; turmeric, sparganium, ... Ligusticum striatum, fermented soybean, and scutellaria baicalensis are used as adjuvant herbs. Curcuma zedoaria and Sparganium stoloniferum have the effects of breaking up blood stasis, promoting qi circulation, eliminating stagnation, and relieving pain. The combination of these two herbs can enhance the effect of breaking up blood stasis and promoting qi circulation of the principal herbs. Ligusticum striatum and fermented soybean can disperse external pathogens, allowing internal cold and dampness to be expelled from the surface. Acanthopanax senticosus, Psoralea corylifolia, Dioscorea nipponica, and Sappanwood are used as guiding herbs. Acanthopanax senticosus and Psoralea corylifolia have the effects of warming the kidneys and assisting yang, dispelling wind and strengthening tendons. The combination of these two herbs, through the use of plaster massage therapy, allows the medicinal power to penetrate the skin and stimulate the meridians and acupoints, thereby achieving the purpose of warming and nourishing, strengthening tendons and bones, and relieving liver and kidney deficiency. Dioscorea nipponica and Sappanwood can further enhance the effects of the prescription in promoting blood circulation, clearing the meridians, reducing swelling, and relieving pain.

[0010] Peach kernel: Efficacy: Promotes blood circulation and removes blood stasis, moistens the intestines and promotes bowel movement, relieves cough and asthma. Characteristics: Strong in breaking up blood stasis and removing blood stasis, good at eliminating masses and accumulations, intestinal abscesses, and lung abscesses, and also moistens the intestines and promotes bowel movement.

[0011] Safflower: Efficacy: Promotes blood circulation and menstruation, disperses blood stasis and relieves pain. Characteristics: It is good at promoting blood circulation and has a strong ability to break up blood stasis. It is a commonly used medicine in gynecology for menstrual regulation, postpartum blood stasis, traumatic injuries, and abdominal masses.

[0012] Honeysuckle vine: Efficacy: Clears heat and detoxifies, dispels wind and unblocks meridians. Cold in nature. Main indications: Rheumatic fever (red, swollen, hot and painful joints), carbuncles and boils, fever due to febrile diseases.

[0013] Loofah sponge: Efficacy: Dispels wind and unblocks meridians, resolves phlegm and detoxifies. Neutral in nature. Indications: Rheumatic pain, chest and rib distension and pain, insufficient lactation, mastitis, cough with phlegm and heat. Light and easily dispels wind, unblocks meridians, and resolves phlegm.

[0014] Curcuma zedoaria: Efficacy: Breaks up blood stasis, promotes qi circulation, eliminates stagnation, and relieves pain. Characteristics: Strong blood-breaking effect; effective in eliminating masses, accumulations, food stagnation, and qi stagnation; often used in combination with Sparganium rhizome. Promotes qi circulation, invigorates blood, and eliminates stagnation.

[0015] Sparganium: Efficacy: Breaks up blood stasis, promotes qi circulation, eliminates stagnation, and relieves pain. Characteristics: Its blood-breaking power is similar to that of Curcuma zedoaria, and it is also good at eliminating masses and accumulations. They are often used together. It is generally believed that Curcuma zedoaria is more inclined to break up qi stasis, while Sparganium is more inclined to break up blood stasis.

[0016] Ligusticum striatum: Efficacy: dispels wind and cold, eliminates dampness and relieves pain. It is effective in treating vertex headache and Taiyang meridian headache (pain in the back of the head extending to the neck and back).

[0017] Lightly fermented soybeans: Efficacy: Relieves exterior symptoms and irritability, disperses stagnant heat. It has a mild medicinal property and can be used in combination with other herbs for exterior syndromes caused by wind-cold or wind-heat. It is particularly effective in treating chest tightness and insomnia caused by febrile diseases.

[0018] Southern Acanthopanax bark: Efficacy: Dispels wind and dampness, tonifies the liver and kidneys, strengthens tendons and bones. Promotes diuresis and reduces swelling (in some varieties). External application: Southern Acanthopanax bark (also known as Fine-column Acanthopanax) has a good effect on tonifying the liver and kidneys and strengthening tendons and bones. It is often used in external prescriptions for wind-cold-dampness arthralgia, lower back and knee pain, and weakness of tendons and bones, such as medicinal wine, plasters, and fumigation washes.

[0019] Psoralea corylifolia: Efficacy: Warms the kidneys and invigorates yang, regulates qi and relieves asthma, warms the spleen and stops diarrhea; externally used to dispel wind and remove blemishes. External applications: Its kidney-warming yang effect is mainly manifested in the treatment of vitiligo, alopecia areata (soaked in alcohol and applied externally), and lower back and knee pain caused by kidney yang deficiency (often combined with other warming and tonifying herbs in medicinal wines or plasters for external use). Although its external effect is not a direct "strengthening of tendons and bones," warming kidney yang itself indirectly helps the tendons and bones.

[0020] Dioscorea nipponica (also known as Dioscorea opposita): Efficacy: Dispels wind and dampness, invigorates blood circulation, resolves phlegm and relieves cough. Neutral in nature. Main indications: Rheumatic pain, lower back and leg pain, numbness, traumatic injuries, sprains, and cough with excessive phlegm. Modern research shows that its extracts have hormone-like anti-inflammatory effects.

[0021] Sappanwood: Efficacy: Promotes blood circulation and removes blood stasis, reduces swelling and relieves pain. Characteristics: Neutral in nature, it is good for treating traumatic injuries, fractures and muscle injuries, swelling and pain due to blood stasis, as well as gynecological blood stasis syndrome and abdominal pain due to blood stasis.

[0022] As a further explanation of the present invention, the traditional Chinese medicine composition comprises the following medicinal materials in parts by weight: 8-12 parts of peach kernel, 8-12 parts of safflower, 6-10 parts of honeysuckle vine, 6-10 parts of loofah sponge, 8-12 parts of turmeric, 8-12 parts of sparganium, 5-8 parts of ligusticum, 3-5 parts of fermented soybean, 5-8 parts of Acanthopanax senticosus bark, 4-6 parts of psoralea corylifolia, 4-6 parts of dioscorea nipponica, and 5-8 parts of sappanwood.

[0023] As a further explanation of the present invention, the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 10 parts peach kernel, 10 parts safflower, 8 parts honeysuckle vine, 8 parts loofah sponge, 10 parts turmeric, 10 parts sparganium, 7 parts ligusticum, 4 parts fermented soybean, 7 parts eleutherococcus senticosus, 5 parts psoralea corylifolia, 5 parts dioscorea nipponica, and 7 parts sappanwood.

[0024] The second aspect of the present invention provides a traditional Chinese medicine preparation for massage, which is a topical preparation of traditional Chinese medicine composed of a fluid extract of traditional Chinese medicine made from the above-mentioned traditional Chinese medicine composition and a base matrix.

[0025] As a further explanation of the present invention, the traditional Chinese medicine external preparation is any one of traditional Chinese medicine massage oil, traditional Chinese medicine massage cream, traditional Chinese medicine massage lotion, traditional Chinese medicine massage balm, traditional Chinese medicine massage gel, traditional Chinese medicine massage tincture, and traditional Chinese medicine massage lotion.

[0026] As a further explanation of the present invention, when the topical Chinese medicine preparation is a Chinese medicine massage cream, the Chinese medicine preparation contains the following components in parts by weight: 10-30 parts of the Chinese medicine fluid extract, 20-40 parts of the oil phase component, 30-50 parts of the aqueous phase component, and 0.1-3 parts of the functional additive.

[0027] As a further explanation of the present invention, the oil phase component contains the following components in parts by weight: 10-15 parts sweet almond oil, 5-10 parts shea butter, 3-8 parts beeswax, 1-5 parts lecithin, and 0.1-3 parts vitamin E oil; the aqueous phase component contains the following components in parts by weight: 25-45 parts deionized water and 5-10 parts glycerin; the functional additive contains the following components in parts by weight: 0.2-0.4 parts phenoxyethanol, 0.2-0.4 parts ethylhexylglycerin, and 0.5-1 parts azone.

[0028] Among them, sweet almond oil in the oil phase is the base oil, which can lubricate and promote penetration; shea butter can thicken, moisturize and improve the texture of the paste; beeswax, as a natural thickener, can thicken the paste; lecithin, as a natural emulsifier, can promote drug penetration; and vitamin E oil can act as an antioxidant to protect the oil.

[0029] In the aqueous phase, deionized water serves as the overall solvent for the ointment, while glycerin acts as a humectant, thickening, solubilizing, and moisturizing agent.

[0030] Phenoxyethanol and ethylhexylglycerin in the functional additives are used as preservatives and are safe and low in irritation. Azone is a chemical penetration enhancer that can enhance the transdermal ability of drugs and enable the drug to reach the affected area quickly.

[0031] The third aspect of the present invention provides the use of the above-mentioned massage-use traditional Chinese medicine composition or the above-mentioned massage-use traditional Chinese medicine preparation in the preparation of a medicament for treating knee osteoarthritis.

[0032] A fourth aspect of this invention provides a method for preparing a traditional Chinese medicine massage cream, comprising the following steps: S1: Prepare the above-mentioned Chinese herbal medicine composition into a Chinese herbal medicine fluid extract for later use; S2: Heat the oil phase to 75-80℃ and stir until completely melted and homogeneous; S3: Heat the aqueous phase to 75-80℃, then add the herbal extract obtained in S1. Mix well and set aside. S4: Slowly pour the homogeneous oil phase component after heating in S2 into the aqueous mixture of Chinese medicine obtained in S3. Stir for 3-5 minutes, then continue stirring and cool to 45-50℃. Add the functional additives, continue stirring and cool to 35-40℃, then stop stirring. After standing at room temperature, the Chinese medicine massage cream is obtained.

[0033] As a further explanation of the present invention, the preparation process of the traditional Chinese medicine fluid extract is as follows: S11: Peach kernel, safflower, honeysuckle vine, loofah sponge, turmeric, sparganium, ligusticum, fermented soybean, eleutherococcus senticosus, psoralea corylifolia, smilax china and sappanwood are ground into coarse powder of 10-20 mesh and then mixed together for later use; S12: Add an appropriate amount of 60-70% ethanol as a solvent to the mixed Chinese herbal powder obtained in S11, stir evenly, seal and let stand to soak: place at room temperature for 2-4 hours to allow the herbs to be fully and evenly moistened and expanded, turning 1-2 times during the period. S13: Put the coarse Chinese medicine powder soaked in S12 into a percolation tube, add 60-70% ethanol and let it stand for 24-48 hours to allow the solvent to fully penetrate the coarse Chinese medicine powder, and then collect the percolate. S14: The percolate collected in S13 is concentrated under reduced pressure until the relative density is between 1.10 and 1.30 to obtain the fluid extract of traditional Chinese medicine.

[0034] This invention uses 60-70% ethanol as a solvent, which can ensure the dissolution of both fat-soluble components (such as the volatile oils and sesquiterpenes of Curcuma zedoaria and Sparganium stoloniferum, the coumarins of Psoralea corylifolia, the fatty oil of Prunus persica, and the pigments of Carthamus tinctorius) and water-soluble components (such as the polysaccharides, amino acids, and chlorogenic acid of Lonicera japonica, Luffa cylindrica, and fermented soybean, and the glycosides of Acanthopanax senticosus).

[0035] This invention uses percolation to prepare fluid extracts, which is particularly suitable for medicinal materials containing a lot of resin, mucilage, and starch (such as peach kernel, loofah sponge, fermented soybean, Acanthopanax senticosus bark, and Dioscorea nipponica in this formula). It can avoid the problems of gelatinization, viscosity, and difficulty in filtration caused by decoction, and can prevent the destruction of heat-sensitive components (such as psoralen and isopsoralen in Psoralea corylifolia, safflower yellow pigment in safflower, volatile oil in Ligusticum striatum, and gemcitabine in Curcuma zedoaria).

[0036] Compared with the prior art, the present invention has the following beneficial technical effects: The massage-grade herbal composition provided by this invention can be combined with plaster massage therapy to form a unique external treatment method for treating various orthopedic diseases, such as various acute and chronic soft tissue injuries (e.g., sprains, muscle strain, fasciitis), stiff neck, cervical spondylosis, frozen shoulder, lumbar disc herniation (remission period), osteoarthritis, spinal facet joint disorders, tenosynovitis, etc. This massage-grade herbal composition combined with plaster massage therapy is particularly effective for knee osteoarthritis, showing significantly better results than ordinary massage plasters. Attached Figure Description

[0037] Figure 1 The statistical results of the concentrations of IL-6, IL-1β and TNF-α in the serum of rats in each group are shown in Table 2 (no significance is marked in the figure).

[0038] Figure 2 The relative gripping force of the hind limbs of rats in each group was statistically analyzed and marked with significance. Detailed Implementation

[0039] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0040] Example 1 This embodiment provides a traditional Chinese medicine massage cream, which is composed of the following components in parts by weight: 25 parts of traditional Chinese medicine fluid extract, 30 parts of oil phase component, 45 parts of water phase component, and 1 part of functional additive.

[0041] The oil phase contains the following components by weight: 12 parts sweet almond oil, 8 parts shea butter, 6 parts beeswax, 3 parts lecithin, and 1 part vitamin E oil; the aqueous phase contains the following components by weight: 35 parts deionized water and 8 parts glycerin; and the functional additives contain the following components by weight: 0.3 parts phenoxyethanol, 0.3 parts ethylhexylglycerin, and 0.7 parts azone.

[0042] The Chinese herbal fluid extract is prepared from a combination of the following medicinal materials in parts by weight: 10 parts peach kernel, 10 parts safflower, 8 parts honeysuckle vine, 8 parts loofah sponge, 10 parts turmeric, 10 parts sparganium, 7 parts ligusticum, 4 parts fermented soybean, 7 parts Acanthopanax senticosus bark, 5 parts psoralea corylifolia, 5 parts dioscorea nipponica, and 7 parts sappanwood.

[0043] Example 2 This embodiment provides a traditional Chinese medicine massage cream, which is composed of the following components in parts by weight: 20 parts of traditional Chinese medicine fluid extract, 30 parts of oil phase component, 50 parts of water phase component, and 2 parts of functional additive.

[0044] The oil phase contains the following components by weight: 13 parts sweet almond oil, 7 parts shea butter, 5 parts beeswax, 4 parts lecithin, and 2 parts vitamin E oil; the aqueous phase contains the following components by weight: 40 parts deionized water and 7 parts glycerin; and the functional additives contain the following components by weight: 0.2 parts phenoxyethanol, 0.4 parts ethylhexylglycerin, and 0.8 parts azone.

[0045] The Chinese herbal fluid extract is prepared from a combination of the following medicinal materials in parts by weight: 9 parts peach kernel, 11 parts safflower, 7 parts honeysuckle vine, 9 parts loofah sponge, 9 parts turmeric, 11 parts sparganium, 6 parts ligusticum, 4 parts fermented soybean, 6 parts eleutherococcus senticosus bark, 5 parts psoralea corylifolia, 5 parts dioscorea nipponica, and 6 parts sappanwood.

[0046] Example 3 This embodiment provides a traditional Chinese medicine massage cream, which is composed of the following components in parts by weight: 10 parts of traditional Chinese medicine fluid extract, 20 parts of oil phase component, 30 parts of water phase component, and 0.1 parts of functional additive.

[0047] The oil phase contains the following components by weight: 10 parts sweet almond oil, 5 parts shea butter, 3 parts beeswax, 1 part lecithin, and 0.1 parts vitamin E oil; the aqueous phase contains the following components by weight: 25 parts deionized water and 5 parts glycerin; and the functional additives contain the following components by weight: 0.2 parts phenoxyethanol, 0.2 parts ethylhexylglycerin, and 0.5 parts azone.

[0048] The Chinese herbal fluid extract is prepared from a combination of the following medicinal materials in parts by weight: 8 parts peach kernel, 8 parts safflower, 6 parts honeysuckle vine, 6 parts loofah sponge, 8 parts turmeric, 8 parts sparganium, 5 parts ligusticum, 3 parts fermented soybean, 5 parts eleutherococcus senticosus, 4 parts psoralea corylifolia, 4 parts dioscorea nipponica, and 5 parts sappanwood.

[0049] Example 4 This embodiment provides a traditional Chinese medicine massage cream, which is composed of the following components in parts by weight: 30 parts of traditional Chinese medicine fluid extract, 40 parts of oil phase component, 50 parts of water phase component, and 3 parts of functional additive.

[0050] The oil phase contains the following components by weight: 15 parts sweet almond oil, 10 parts shea butter, 8 parts beeswax, 5 parts lecithin, and 3 parts vitamin E oil; the aqueous phase contains the following components by weight: 45 parts deionized water and 10 parts glycerin; and the functional additives contain the following components by weight: 0.4 parts phenoxyethanol, 0.4 parts ethylhexylglycerin, and 1 part azone.

[0051] The Chinese herbal fluid extract is prepared from a combination of the following medicinal materials in parts by weight: 12 parts peach kernel, 12 parts safflower, 10 parts honeysuckle vine, 10 parts loofah sponge, 12 parts turmeric, 12 parts sparganium, 8 parts ligusticum, 5 parts fermented soybean, 8 parts Acanthopanax senticosus bark, 6 parts psoralea corylifolia, 6 parts dioscorea nipponica, and 8 parts sappanwood.

[0052] Comparative Example 1: This comparative example provides a traditional Chinese medicine massage cream, which differs from Example 1 in that it removes safflower and loofah from the traditional Chinese medicine composition.

[0053] Comparative Example 2: This comparative example provides a traditional Chinese medicine massage cream, which differs from Example 1 in that it removes Ligusticum striatum and fermented soybean from the traditional Chinese medicine composition.

[0054] Comparative Example 3: This comparative example provides a traditional Chinese medicine massage cream, which differs from Example 1 in that it removes Acanthopanax senticosus bark and Psoralea corylifolia from the traditional Chinese medicine composition.

[0055] Comparative Example 4: This comparative example provides a traditional Chinese medicine massage cream, which differs from Example 1 in that it removes *Dioscorea nipponica* and *Caesalpinia sappan* from the traditional Chinese medicine composition.

[0056] Comparative Example 5: This comparative example provides a traditional Chinese medicine massage cream, which differs from Example 1 in that the Ligusticum striatum and fermented soybean in the traditional Chinese medicine composition are replaced with Ephedra sinica and Perilla frutescens leaves, respectively.

[0057] The preparation process of the herbal massage cream provided in Examples 1-4 above is as follows (the dosage of each herb and component in the massage cream is converted according to the corresponding examples during the preparation process): S1: Prepare the above-mentioned Chinese herbal medicine composition into a Chinese herbal medicine fluid extract for later use; S2: Mix all oil phase components and heat to 75°C, stirring until completely melted and homogeneous for later use; S3: Mix the aqueous components and heat to 75°C. Then add the herbal extract obtained in S1 and stir until homogeneous before use. S4: Slowly pour the homogeneous oil phase component after heating in S2 into the aqueous mixture of Chinese medicine obtained in S3. Stir for 4 minutes, continue stirring and cool to 45°C, then add the functional additives in sequence. Continue stirring and cool to 35°C, then stop stirring. After standing at room temperature, the Chinese medicine massage cream is obtained.

[0058] The specific preparation process of S1 herbal fluid extract is as follows: S11: Grind peach kernel, safflower, honeysuckle vine, loofah sponge, turmeric, sparganium, ligusticum, fermented soybean, eleutherococcus senticosus, psoralea corylifolia, smilax china and sappanwood into 10-mesh coarse powder and mix them together for later use. S12: Add an appropriate amount of 65% ethanol as a solvent to the mixed Chinese herbal powder obtained in S11, stir evenly, seal and let stand to soak: place at room temperature for 3 hours to allow the herbs to be fully and evenly moistened and expanded, turning 1-2 times during the period. S13: Place absorbent cotton at the bottom of the percolation cylinder, then fill the percolation cylinder with the coarse Chinese medicine powder soaked in S12 in batches, with even density. Gently compact each layer to avoid obvious gaps (the filling height of the coarse Chinese medicine powder should be controlled at about 2 / 3 of the height of the percolation cylinder). Cover the top of the medicine with a layer of absorbent cotton, slowly open the lower outlet of the percolation cylinder to allow the air inside the cylinder to be expelled, and then slowly add 65% ethanol until the liquid level is about 3cm above the medicine powder. Close the outlet, seal the upper opening of the percolation cylinder, and let it stand for 36 hours to allow the solvent to fully penetrate the coarse Chinese medicine powder. Then slowly collect the percolate, continuously adding 65% ethanol during the collection process to keep the liquid level always above the medicine powder. Collect the concentrated percolate, which is about 85% of the initial amount of medicine, and continue percolation to collect the subsequent diluted percolate, which is 4 times the amount of medicine. S14: After combining the concentrated and dilute permeate collected in S13, concentrate the extract under reduced pressure at ≤60℃ until the relative density is 1.20 to obtain the traditional Chinese medicine fluid extract.

[0059] The difference between the preparation process of the Chinese herbal massage cream provided in Comparative Examples 1-5 and the preparation process of Examples 1-4 is that when a certain Chinese herbal medicine is removed, the Chinese herbal medicine is omitted in the corresponding preparation step. When it is necessary to replace it with ephedra and perilla leaves, in S11, the ephedra and perilla leaves are crushed into 10-mesh coarse powder and then mixed with other Chinese herbal coarse powders for later use. The remaining steps are the same as in Example 1.

[0060] Animal experiments: 1.1 Experimental Materials: Pharmaceuticals: Voltaren ointment, Novartis Pharmaceuticals, Beijing; the traditional Chinese medicine massage creams provided in Example 1 and Comparative Examples 1-5 above.

[0061] Experimental animals: 120 male SD rats (weight: 180-220g) were obtained from the Experimental Animal Center of Changchun University of Traditional Chinese Medicine. After the rats were purchased, they were placed under SPF-grade conditions for an acclimatization trial for one week before the experiment.

[0062] 1.2 Establishment of animal models and intervention treatment process: Grouping: 120 rats were randomly divided into the following groups: low-dose ointment group of Example 1, medium-dose ointment group of Example 1, high-dose ointment group of Example 1, high-dose ointment group of Comparative Examples 1-5, positive ointment group, high-dose application group of Example 1, blank group, and model group, with 10 rats in each group.

[0063] Establishment of the knee osteoarthritis (KOA) model: Rats in all groups except the control group were anesthetized by intraperitoneal injection of sodium pentobarbital. The rats were then fixed in a supine position with the knee joint exposed. 1 mg of iodoacetic acid was dissolved in 50 μL of physiological saline and injected into the knee joint cavity of the rats. Five days after model establishment, HE staining pathological examination was performed on the rats. Inflammation, cartilage degeneration, and osteophyte formation were observed in the joint cavity, indicating successful model establishment.

[0064] Ointment Massage Therapy: Five days after modeling, rats in all groups except the model group, blank group, and the high-dose patch application group of Example 1 were fixed on the operating table with their limbs extended. The herbal massage ointment and diclofenac ointment obtained in the above examples and comparative examples were then applied around the rats' knee joints. Before massage, the rats were ensured to be in a comfortable and quiet environment to reduce stress. The area around the knee joint was gently massaged with fingertips, pushing from the groin towards the knee joint to aid drug absorption and promote blood circulation. Simultaneously, acupressure was gently applied to the acupoints around the knee joint. Each massage lasted approximately 10 minutes to ensure full drug penetration and action, while avoiding excessive fatigue. Massage was performed once daily for three weeks.

[0065] The dosage of massage ointment applied to each group of rats during each treatment was as follows: Example 1 low-dose massage ointment group: 2.5 g / kg of the herbal massage ointment obtained in Example 1; Example 1 medium-dose massage ointment group: 5 g / kg of the herbal massage ointment obtained in Example 1; Example 1 high-dose massage ointment group: 10 g / kg of the herbal massage ointment obtained in Example 1; Comparative Examples 1-5 high-dose massage ointment group: 10 g / kg of the massage cream obtained in Comparative Examples 1-5; Positive control group: 10 g / kg of diclofenac sodium ointment.

[0066] Application therapy: Five days after modeling, the rats in the high-dose application group of Example 1 were fixed on the operating table with their limbs in an extended position. The herbal massage cream obtained in Example 1 was then applied around the knee joint of the rats at a dosage of 10g / kg.

[0067] Note: When applying the massage cream and massaging, ensure that the application area of ​​each group of rats is basically the same and that the application and massage treatment is performed at the same time every day to avoid environmental interference.

[0068] 1.3 Observation indicators: 1.3.1 Detection of inflammatory markers in serum After treatment with ointment and plaster, rats in each group, as well as the model group and the blank group, were anesthetized by intraperitoneal injection of sodium pentobarbital. Blood was collected from the abdominal aorta, and the concentrations of inflammatory factors IL-6 (interleukin-6), IL-1β (interleukin-1β), and TNF-α (tumor necrosis factor-α) in the serum of each group of rats were measured by enzyme-linked immunosorbent assay (ELISA).

[0069] 1.3.2 Rat grip strength test After treatment with ointment and plaster, rats in each group, as well as the model group and the blank group, had their hind limbs placed flat on the sensing rod of a grip strength meter (GSM). The upper body of the rats was suspended, with their bodies at approximately a 30° angle to the grip plate. The rats were then pulled backward until their claws were released, and the grip strength of both hind limbs was measured. The measurement was repeated three times, and the maximum value was recorded as the absolute grip strength. The absolute grip strength was divided by body mass to obtain the relative grip strength, which was used to characterize the rat's grip strength.

[0070] 1.3.3 Pathological scoring of cartilage tissue Rats were euthanized, and the knee joint tissue of the rats after modeling was fixed in a fixative solution. The fixed rat knee joint tissue was placed in a tissue embedding cassette, and then subjected to alcohol gradient dehydration, xylene clearing and paraffin embedding. Sectioning and dewaxing were performed, followed by hematoxylin staining and eosin staining. Finally, the slides were mounted with neutral resin.

[0071] Pathological scoring: The above-mentioned hematoxylin-eosin stained slides were mounted with neutral resin, observed under an optical microscope, and scored pathologically. The scoring criteria are shown in Table 1 below: Table 1. Cartilage Pathology Scoring Criteria (0-6 points, scored based on the most severe area)

[0072] 1.4 Statistical Methods: The t-test was used for continuous data, and the χ² test was used for categorical data. 2 Verification. All measurement data were analyzed using... It is indicated that SPSS version 22.0 was used for data processing.

[0073] 1.5 Experimental Results: 1.5.1 Comparison of serum levels of IL-6, IL-1β and TNF-α in different groups of rats.

[0074] Table 2. Changes in serum IL-6, IL-1β, and TNF-α levels in rats of different groups.

[0075] Note: Compared with the blank group, # P<0.05 ##P<0.01; compared with the model group, , Compared with the high-dose ointment group in Example 1, , n=10.

[0076] Serum IL-6, IL-1β, and TNF-α are three important pro-inflammatory cytokines. Therefore, this invention measured the levels of pro-inflammatory cytokines in rats of different groups to characterize the degree of joint inflammation in different groups. Specific detection results are shown in Table 2 and... Figure 1 As shown in Table 2 and Figure 1 As can be seen, compared with the blank group, the serum concentrations of IL-6, IL-1β, and TNF-α in the model group rats were significantly increased. However, compared with the model group rats, the serum concentrations of IL-6, IL-1β, and TNF-α in the positive ointment massage group, the low, medium, and high dose ointment massage groups of Example 1, and the high dose application group of Example 1 were significantly decreased, indicating that the herbal massage ointment provided by this invention can effectively reduce the inflammation degree in rats with knee osteoarthritis. Compared with the high dose application group of Example 1 rats, the decrease in serum concentrations of IL-6, IL-1β, and TNF-α in the high dose ointment massage group of Example 1 was more significant, and the difference was statistically significant, indicating that the herbal massage ointment provided by this invention can produce a synergistic effect with ointment massage therapy, and its effect is superior to that of applying the herbal massage ointment provided by this invention alone.

[0077] 1.5.2 Results of gripping force test in each group of rats.

[0078] Table 3 Results of relative gripping force of rat hind limbs in each group

[0079] Note: Compared with the blank group, # P<0.05 ## P<0.01; compared with the model group, , Compared with the high-dose ointment group in Example 1, , n=10.

[0080] Knee osteoarthritis leads to limited joint mobility and muscle atrophy. Grasping strength in rats reflects their muscle strength and joint function; therefore, gripping strength testing can quantify these changes. Furthermore, knee osteoarthritis causes pain, reducing mobility and gripping strength. Grasping strength testing can indirectly assess the impact of pain on rats. Therefore, this invention tested the gripping strength of different groups of rats. Specific test results are shown in Table 3 and... Figure 2 As shown in Table 3 and Figure 2As can be seen, compared with the blank group, the relative grip strength of the hind limbs of the model group rats was significantly weakened, indicating that knee osteoarthritis had a significant negative impact on the grip strength of the rats. However, compared with the model group rats, the relative grip strength of the hind limbs of the positive plaster group, the low, medium, and high dose plaster groups of Example 1, and the high dose plaster application group of Example 1 was significantly increased, and the differences were statistically significant. This indicates that the herbal massage plaster provided by this invention can effectively enhance muscle strength and joint function in rats with knee osteoarthritis and relieve pain. Furthermore, compared with the high dose plaster application group of Example 1, the relative grip strength of the hind limbs of the high dose plaster group of Example 1 showed a more significant improvement, and the difference was statistically significant. This indicates that the herbal massage plaster provided by this invention can produce a synergistic effect with plaster massage therapy, and its effect is superior to that of applying the herbal massage plaster provided by this invention alone. Finally, compared with the rats in the high-dose ointment massage group of Comparative Examples 1-5, the rats in the high-dose ointment massage group of Example 1 showed a more significant improvement in the relative grip strength of their hind limbs, and the difference was statistically significant. This indicates that the absence or replacement of any one of the Chinese herbs in the herbal composition of this invention will weaken the improvement effect of the herbal massage ointment. This shows that the herbal composition provided by this invention has obvious synergistic effects. No matter whether some single Chinese herbs are removed or replaced, the final therapeutic effect is not ideal. This also reflects the unique compatibility advantage of the herbal composition provided by this invention.

[0081] 1.5.3 Pathological scores of cartilage tissue in each group of rats.

[0082] Table 4. Pathological scores of rat cartilage tissue in each group.

[0083] Note: Compared with the blank group, # P<0.05 ## P<0.01; compared with the model group, , Compared with the high-dose ointment group in Example 1, , n=10.

[0084] HE staining pathological scores can intuitively and quantitatively reflect the pathological changes in cartilage tissue of rats with knee osteoarthritis, including the degree of cartilage degeneration, chondrocyte morphology, matrix degradation, and inflammatory response. Scoring these changes quantifies the pathological severity of knee osteoarthritis. Therefore, this invention stained rats in each group with HE and scored their pathology. The specific scoring results are shown in Table 4. Table 4 shows that compared to the blank group, the pathological scores of the model group rats were significantly higher, indicating that the cartilage tissue of rats with knee osteoarthritis had significant lesions. Compared to the model group rats, the pathological scores of the positive ointment group, the low, medium, and high dose ointment groups of Example 1, and the high dose application group of Example 1 were significantly lower, and the differences were statistically significant, indicating that the herbal massage ointment provided by this invention can effectively alleviate the degree of cartilage tissue lesions in rats with knee osteoarthritis. Compared to the high dose application group of Example 1 rats, the pathological score reduction in the high dose ointment group of Example 1 was more significant, and the difference was statistically significant, indicating that the herbal massage ointment provided by this invention can produce a synergistic effect with ointment therapy, and its effect is better than using the herbal massage ointment provided by this invention alone for application therapy. Finally, compared with the rats in the high-dose ointment massage group of Comparative Examples 1-5, the rats in the high-dose ointment massage group of Example 1 showed a more significant reduction in pathological scores, and the difference was statistically significant. This indicates that the absence or replacement of any one of the Chinese herbs in the herbal composition of the present invention will weaken the improvement effect of the herbal massage ointment. This shows that the herbal composition provided by the present invention has obvious synergistic effects. No matter whether some single Chinese herbs are removed or replaced, the final therapeutic effect is not ideal. This also reflects the unique compatibility advantage of the herbal composition provided by the present invention.

[0085] It should be noted that, in this document, terms such as “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0086] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for massage, characterized in that, This traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: peach kernel, safflower, honeysuckle vine, loofah sponge, turmeric, sparganium, ligusticum, fermented soybean, eleutherococcus senticosus, psoralea corylifolia, smilax china, and sappanwood.

2. The massage herbal composition as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 8-12 parts peach kernel, 8-12 parts safflower, 6-10 parts honeysuckle vine, 6-10 parts loofah sponge, 8-12 parts turmeric, 8-12 parts sparganium, 5-8 parts ligusticum, 3-5 parts fermented soybean, 5-8 parts southern eleutherococcus bark, 4-6 parts psoralea, 4-6 parts dioscorea nipponica, and 5-8 parts sappanwood.

3. The massage herbal composition as described in claim 1, characterized in that, The traditional Chinese medicine composition consists of the following medicinal materials in parts by weight: 10 parts peach kernel, 10 parts safflower, 8 parts honeysuckle vine, 8 parts loofah sponge, 10 parts turmeric, 10 parts sparganium, 7 parts ligusticum, 4 parts fermented soybean, 7 parts eleutherococcus senticosus bark, 5 parts psoralea corylifolia, 5 parts dioscorea nipponica, and 7 parts sappanwood.

4. A traditional Chinese medicine preparation for massage, characterized in that, The traditional Chinese medicine preparation is a topical preparation of traditional Chinese medicine composed of a fluid extract of traditional Chinese medicine made from the traditional Chinese medicine composition according to any one of claims 1-3 and a base matrix.

5. The massage-grade traditional Chinese medicine preparation as described in claim 4, characterized in that, The traditional Chinese medicine preparation contains the following components in parts by weight: 10-30 parts of the traditional Chinese medicine fluid extract, 20-40 parts of the oil phase component, 30-50 parts of the aqueous phase component, and 0.1-3 parts of the functional additive.

6. The massage-grade traditional Chinese medicine preparation as described in claim 5, characterized in that, The oil phase composition contains the following components in parts by weight: 10-15 parts sweet almond oil, 5-10 parts shea butter, 3-8 parts beeswax, 1-5 parts lecithin, and 0.1-3 parts vitamin E oil; the aqueous phase composition contains the following components in parts by weight: 25-45 parts deionized water and 5-10 parts glycerin; the functional additives contain the following components in parts by weight: 0.2-0.4 parts phenoxyethanol, 0.2-0.4 parts ethylhexylglycerin, and 0.5-1 parts azone.

7. The massage-grade traditional Chinese medicine preparation as described in claim 4, characterized in that, The aforementioned external Chinese medicine preparation is any one of the following: Chinese medicine massage oil, Chinese medicine massage cream, Chinese medicine massage lotion, Chinese medicine massage balm, Chinese medicine massage gel, Chinese medicine massage tincture, and Chinese medicine massage lotion.

8. The use of the traditional Chinese medicine composition for massage according to any one of claims 1-3 or the traditional Chinese medicine preparation for massage according to any one of claims 4-7 in the preparation of a medicament for treating knee osteoarthritis.

9. A method for preparing a traditional Chinese medicine massage cream, characterized in that, Includes the following steps: S1: Prepare a traditional Chinese medicine fluid extract from the traditional Chinese medicine composition according to any one of claims 1-3 for later use; S2: Heat the oil phase to 75-80℃ and stir until completely melted and homogeneous; S3: Heat the aqueous phase to 75-80℃, then add the herbal extract obtained in S1. Mix well and set aside. S4: Slowly pour the homogeneous oil phase component after heating in S2 into the aqueous mixture of Chinese medicine obtained in S3. Stir for 3-5 minutes, then continue stirring and cool to 45-50℃. Add the functional additives, continue stirring and cool to 35-40℃, then stop stirring. After standing at room temperature, the Chinese medicine massage cream is obtained.

10. The method for preparing the traditional Chinese medicine massage cream as described in claim 9, characterized in that, The preparation process of the traditional Chinese medicine fluid extract is as follows: S11: Peach kernel, safflower, honeysuckle vine, loofah sponge, turmeric, sparganium, ligusticum, fermented soybean, eleutherococcus senticosus, psoralea corylifolia, smilax china and sappanwood are ground into coarse powder of 10-20 mesh and then mixed together for later use; S12: Add an appropriate amount of 60-70% ethanol as a solvent to the mixed Chinese herbal powder obtained in S11, stir evenly, seal and let stand to soak: place at room temperature for 2-4 hours to allow the herbs to be fully and evenly moistened and expanded, turning 1-2 times during the period. S13: Put the coarse Chinese medicine powder soaked in S12 into a percolation cylinder, add 60-70% ethanol and let it stand for 24-48 hours to allow the solvent to fully penetrate the coarse Chinese medicine powder, and then collect the percolate. S14: The percolate collected in S13 is concentrated under reduced pressure until the relative density is between 1.10 and 1.30 to obtain the fluid extract of traditional Chinese medicine.

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