Joint relaxing and activating collateral dredging application as well as preparation method and application thereof

Abstract

The invention provides a joint activating and collateral dredging application and a preparation method and application thereof.The joint activating and collateral dredging application is formed by compounding multiple traditional Chinese medicines such as frankincense, myrrh, ligusticum wallichii, radix angelicae pubescentis, lycopodium clavatum and garden balsam stem with a matrix material, nano borneol, microencapsulated menthol and a fat-soluble vitamin E derivative are added as synergistic components; the preparation method comprises the following steps: supercritical CO2 extraction of volatile oil, microwave-assisted water extraction of active components, and high-pressure homogenization and micro-fluidic chip molding technologies are combined to prepare the porous flexible patch. According to the application, medicine absorption is promoted through a nano transdermal technology, a TNF-alpha / IL-1beta inflammation pathway is remarkably inhibited, clinical data shows that the cure rate of the application reaches 35%, the effective rate of the application reaches 75%, and the application can effectively relieve arthralgia and activity limitation caused by rheumatic arthritis, osteoarthritis and the like. The transdermal patch has the characteristics of high transdermal efficiency, lasting effect and convenience in use.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine external preparations, and in particular to a joint soothing and collateral unblocking compress and a preparation method and application thereof. Background Art

[0002] With the acceleration of modern life and the increase of work pressure, joint diseases have become a major problem that troubles people's health. Rheumatoid arthritis, rheumatoid arthritis, osteoarthritis and joint sprains are common and frequently-occurring diseases in clinical practice, which seriously affect the quality of life of patients. These diseases are often accompanied by symptoms such as joint pain, swelling, and limited mobility, which bring great pain to patients and seriously affect their quality of life and work ability.

[0003] At present, there are various treatments for joint diseases. In terms of drug treatment, although non-steroidal anti-inflammatory drugs can relieve pain and inflammation to a certain extent, long-term use may cause adverse reactions such as gastrointestinal discomfort and liver and kidney damage; although glucocorticoids have significant anti-inflammatory effects, they have side effects such as osteoporosis and increased risk of infection. Surgical treatment is suitable for patients with more serious conditions, but the surgery is traumatic, the recovery time is long, and there are certain surgical risks.

[0004] In topical drug treatment, common joint dressings or plasters are easy to use, but they have problems such as poor drug permeability and difficulty for active ingredients to penetrate into the joint lesions, resulting in limited therapeutic effects. At the same time, existing topical preparations are relatively traditional in the selection and compatibility of drug ingredients, lack innovative synergistic ingredients and reasonable matrix formulas, and are difficult to fully exert the synergistic effects of drugs. Moreover, the preparation process of some dressings is simple, and the stability and effectiveness of the drugs cannot be guaranteed, which affects the clinical efficacy. Summary of the invention

[0005] In view of this, the present invention proposes a joint soothing and collateral unblocking compress and a preparation method and application thereof to solve the above problems.

[0006] The technical scheme of the present invention is achieved as follows: a joint soothing and collateral-draining compress comprises the following raw materials in parts by weight: 5-15 parts of frankincense, 5-15 parts of myrrh, 10-20 parts of chuanxiong, 10-20 parts of angelica dahurica, 15-25 parts of schizonepeta tenuifolia, 15-25 parts of radix spatholobi, 10-20 parts of wormwood, 8-18 parts of safflower, 2-8 parts of borneol, 8-18 parts of airplane grass, 10-20 parts of moneywort, 10-20 parts of banana buds, 10-20 parts of dandelions, 8-18 parts of coconut flowers, 10-20 parts of isatis indigotica, 5-15 parts of coconut roots, and 30-50 parts of matrix materials.

[0007] Furthermore, the matrix material is composed of the following ingredients in parts by weight: 10-20 parts of vaseline, 5-15 parts of lanolin, 5-15 parts of sodium carboxymethyl cellulose, and 10-20 parts of glycerol.

[0008] Furthermore, the invention also contains synergistic ingredients: 1-3 parts of nano-borneol with a particle size of ≤100 nm, 0.5-2 parts of microencapsulated menthol, and 0.5-1.5 parts of fat-soluble vitamin E derivatives, wherein the encapsulation rate of the microencapsulated menthol is ≥90%.

[0009] Furthermore, the fat-soluble vitamin E derivative is selected from any one of α-tocopherol, β-tocopherol, α-tocotrienol, and vitamin E acetate.

[0010] Furthermore, the frankincense and myrrh are treated with vinegar roasting, and the specific method of the vinegar roasting treatment is: mix the frankincense and myrrh with rice vinegar in a weight ratio of 1: (0.1-0.3), mix well, and simmer for 1-3 hours, then stir over a low heat until the surface is slightly melted and a vinegar aroma escapes, then take out, cool, and dry.

[0011] Furthermore, a method for preparing a joint soothing and collateral-unblocking compress comprises the following steps:

[0012] S1. Grind frankincense, myrrh, Chuanxiong, Angelica dahurica, Herba Lycopodii, Herba Artemisiae Argyi, Folium ...

[0013] S2, extracting frankincense, myrrh, chuanxiong, angelica dahurica, wormwood leaf and borneol by supercritical CO2 extraction for 2-4 hours to obtain volatile oil extract;

[0014] S3, using microwave-assisted water extraction method on lycopodii, safflower, lycopodii, lycopodiella, banana bud, dandelion, coconut flower, isatis indigo leaf, and coconut root, with a solid-liquid ratio of 1:15-20, extracting 1-3 times, each time for 20-40 minutes, combining the extracts, and concentrating to a relative density of 1.10-1.15 to obtain a water extract concentrate;

[0015] S4, heating the matrix material to 60-65°C, adding the volatile oil extract of S2 and stirring until it becomes a colloid;

[0016] S5, slowly add the water extract concentrate obtained in S3 to the matrix mixture of S4, and emulsify at a high speed of 5000-8000 rpm for 10-15 minutes, homogenize 2-3 times with a high-pressure homogenizer at a pressure of 50-80 MPa to obtain a uniform and delicate milky matrix, cool to 40-45°C, add nano-borneol, and stir evenly;

[0017] S6. The preparation is formed by using microfluidic chip technology, with a channel width of 100-200 μm and a flow rate ratio of 3:1, to obtain a flexible patch with a porous structure, a porosity of 40-60%, and a pore size of 10-50 μm. After packaging and sterilization, the joint soothing and unblocking compress is obtained.

[0018] Furthermore, the extraction conditions of S2 are: pressure 25-30MPa, temperature 40-45°C, CO2 flow rate 20-25L / h.

[0019] Furthermore, the microwave power of S3 is 400-500W, and the extraction temperature is 80-90°C.

[0020] Furthermore, the joint soothing and unblocking meridians compress is used in the preparation of medicines for treating diseases related to joint pain and limited joint movement.

[0021] Furthermore, the diseases related to joint pain and limited joint movement include rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, and joint sprains.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] (1) Scientific and reasonable compatibility of medicinal materials: The compress uses a variety of Chinese medicinal materials such as frankincense, myrrh, and Chuanxiong, and the various medicinal materials are compatible with each other. Frankincense and myrrh can promote blood circulation, promote qi and relieve pain, Chuanxiong can promote blood circulation, promote qi and relieve wind and pain, Duhuo can dispel wind and dampness, relieve numbness and relieve pain, Achyranthes bidentata and Penisula can dispel wind and dampness, relax muscles and activate collaterals, Artemisia argyi can warm the meridians and dispel cold, and Safflower can promote blood circulation and remove blood stasis. The combined action of multiple medicinal materials can effectively improve local blood circulation in joints, reduce inflammatory reactions, relieve joint pain and swelling, and promote joint function recovery. It has a good therapeutic effect on various joint diseases such as rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, and joint sprains.

[0024] (2) Excellent matrix formula: The unique matrix material is composed of vaseline, lanolin, sodium carboxymethyl cellulose and glycerin. Vaseline and lanolin can enhance the moisturizing and adhesion of the dressing, allowing the drug to better adhere to the joint skin surface; sodium carboxymethyl cellulose and glycerin help adjust the consistency and moisturizing properties of the dressing, promote the penetration and release of the drug, ensure that the drug continues to act on the lesion site, and improve the treatment effect.

[0025] (3) Unique synergistic ingredients: Nano-borneol with a particle size of ≤100nm, microencapsulated menthol, fat-soluble vitamin E derivatives and other synergistic ingredients are added. Nano-borneol has good transdermal properties and can promote drug absorption; microencapsulated menthol can slowly release cooling ingredients, enhance local comfort, and have a certain anti-inflammatory effect; fat-soluble vitamin E derivatives have antioxidant effects and can protect joint tissues from free radical damage, further enhancing the therapeutic effect of the dressing.

[0026] (4) Processing methods to improve drug efficacy: Frankincense and myrrh are treated with vinegar and mixed with rice vinegar in a specific proportion, then steamed and fried to enhance their blood circulation, blood stasis and pain relief effects. This can also reduce the irritation of the drugs and improve their safety and effectiveness.

[0027] (5) Advanced preparation technology: The supercritical CO2 extraction method is used to extract volatile oils, which can retain the effective ingredients in the medicinal materials to the maximum extent and improve the purity and activity of the extracts; the microwave-assisted water extraction method is used to extract other medicinal ingredients, which has the advantages of high extraction efficiency, short extraction time and low energy consumption. High-speed shear emulsification and high-pressure homogenization operations make the matrix mixing more uniform and delicate, which is conducive to the dispersion and stability of the drug. The flexible patch with a porous structure prepared by microfluidic chip technology has moderate porosity and pore size, which is conducive to the storage and release of drugs, and at the same time enhances the fit and comfort of the dressing to the skin. DETAILED DESCRIPTION

[0028] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0029] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0030] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0031] The following introduces the basic information of the main raw materials based on the "Chinese Pharmacopoeia", "Chinese Materia Medica Dictionary" and "Chinese Herbal Medicine".

[0032] Frankincense: Nature and flavor: pungent, bitter, warm. It enters the heart, liver, and spleen meridians. Functions and indications: promoting blood circulation, promoting qi, relieving pain, reducing swelling and promoting tissue regeneration. It is used for chest pain, heart pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal pain due to stagnation, rheumatic pain, muscle spasm, traumatic injury, carbuncle, ulcer.

[0033] Myrrh: Nature and flavor: pungent, bitter, neutral. It enters the heart, liver, and spleen meridians. Functions and indications: dispersing blood stasis and relieving pain, reducing swelling and promoting tissue regeneration. It is used for chest pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal pain due to stagnation, rheumatic pain, traumatic injury, carbuncle, ulcer, etc. It is often used together with frankincense to enhance the effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration.

[0034] Chuanxiong: Nature and flavor: pungent, warm. Enters the liver, gallbladder, and pericardium meridians. Functions and indications: promotes blood circulation and qi, dispels wind and relieves pain. It can be used for irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to lumps, stabbing pain in the chest and ribs, swelling and pain due to falls, headache, rheumatic pain, etc. It is especially good at treating headaches, and there is a saying that "Chuanxiong is indispensable for headaches."

[0035] Duhuo: Nature and flavor: pungent, bitter, slightly warm. Enters the kidney and bladder meridians. Functions and indications: dispel wind and dampness, relieve numbness and relieve pain. Used for wind-cold-dampness arthralgia, pain in the waist and knees, headache due to wind in Shaoyin, headache due to wind-cold and dampness, etc.

[0036] Stretching tendons: Nature and flavor: pungent, bitter, warm. Enters the liver, spleen, and kidney meridians. Functions and indications: dispel wind and dampness, relax tendons and activate collaterals. Can treat rheumatic arthralgia, tendon spasm, flexion and extension difficulties, traumatic injuries, etc.

[0037] Herba Tougucao: Nature and flavor: pungent, bitter, warm; slightly toxic. Enters the liver and kidney meridians. Functions and indications: dispel wind and dampness, relax muscles and activate collaterals, promote blood circulation and relieve pain, detoxify and resolve rashes. Commonly used for rheumatic arthralgia, muscle and bone contracture, cold and damp beriberi, waist sprain, limb numbness, traumatic injury, sores, swelling and toxins, eczema, etc.

[0038] Mugwort leaf: Nature and flavor: pungent, bitter, warm; slightly toxic. Enters the liver, spleen, and kidney meridians. Functions and indications: warms the meridians and stops bleeding, dispels cold and stops pain; externally used to dispel dampness and stop itching. Used for vomiting blood, epistaxis, metrorrhagia, menorrhagia, fetal bleeding, cold pain in the lower abdomen, irregular menstruation, and infertility caused by cold uterus; externally used to treat skin itching. Vinegar and mugwort charcoal warm the meridians and stop bleeding, and are used for bleeding caused by deficiency and cold.

[0039] Safflower: Nature and flavor: pungent, warm. Enters the heart and liver meridians. Functions and indications: promote blood circulation and menstruation, dissipate blood stasis and relieve pain. Used for amenorrhea, dysmenorrhea, lochia retention, lumps and masses, chest pain, abdominal pain due to stasis, stabbing pain in the chest and ribs, injuries from falls, sores and swelling, etc.

[0040] Airplane grass: Nature and flavor: slightly pungent, slightly bitter, warm; toxic. Enters the liver and kidney meridians. Functions and indications: dissipates blood stasis and reduces swelling, stops bleeding, kills insects. For external use, it can treat swelling and pain from falls, bleeding from trauma, swelling and poison from sores, burns, itchy skin, leprosy, chronic ulcers, etc. However, due to its toxicity, it should be used with caution.

[0041] Herba Lysimachiae: Nature and flavor: sweet, salty, slightly cold. Enters the liver, gallbladder, kidney, and bladder meridians. Functions and indications: promotes dampness and relieves jaundice, promotes diuresis and relieves stranguria, detoxifies and reduces swelling. Used for damp-heat jaundice, gallbladder distension and hypochondriasis, stranguria with stones, stranguria with heat, painful and astringent urination, carbuncle, furuncle, snake and insect bites.

[0042] Banana buds: Nature and flavor: sweet, slightly spicy, cold. Enters the heart and liver meridians. Functions: clearing away heat and detoxifying, cooling blood, relieving pain. Can be used to treat headaches, stomachaches, abdominal pain, thirst, carbuncle, heat toxins, etc.

[0043] Dandelion: Nature and flavor: bitter, sweet, cold. Enters the liver and stomach meridians. Functions and indications: clearing away heat and detoxifying, reducing swelling and dispersing stagnation, diuresis and relieving stranguria. Used for carbuncle, breast carbuncle, scrofula, red eyes, sore throat, lung carbuncle, intestinal carbuncle, damp-heat jaundice, hot stranguria and astringent pain, etc.

[0044] Coconut flower: Nature and flavor: sweet, light, neutral. Enters the spleen and stomach meridians. Functions and indications: replenishing qi, dispelling wind, relieving itching. Used to treat diabetes, sinusitis, warts, etc.

[0045] Folium Isatidis: Nature and flavor Meridian: bitter, cold. Enters the heart and stomach meridians. Functions and indications: clears away heat and detoxifies, cools blood and eliminates spots. Used for high fever due to febrile diseases, coma, spots and rashes, mumps, throat paralysis, erysipelas, carbuncle, etc.

[0046] Coconut root: Nature and flavor: sweet, light, cool in nature. Enters the liver and kidney meridians. Functions and indications: stop bleeding, relieve pain, promote diuresis and reduce swelling.

[0047] Example 1

[0048] A joint soothing and collateral-unblocking compress comprises the following raw materials by weight: 5 grams of frankincense, 5 grams of myrrh, 10 grams of chuanxiong, 10 grams of angelica dahurica, 15 grams of smilax china, 15 grams of peony root, 10 grams of wormwood, 8 grams of safflower, 2 grams of borneol, 8 grams of airplane grass, 10 grams of money grass, 10 grams of banana bud, 10 grams of dandelion, 8 grams of coconut flower, 10 grams of isatis indigotica, 5 grams of coconut root, 10 grams of vaseline, 5 grams of lanolin, 5 grams of sodium carboxymethyl cellulose, 10 grams of glycerin, 1 gram of nano-borneol, 0.5 grams of microencapsulated menthol, and 0.5 grams of alpha-tocopherol.

[0049] Example 2

[0050] A joint soothing and collateral-unblocking compress comprises the following raw materials by weight: 15 grams of frankincense, 15 grams of myrrh, 20 grams of chuanxiong, 20 grams of angelica dahurica, 25 grams of smilax glabra, 25 grams of radix polygoni avicularis, 20 grams of wormwood, 18 grams of safflower, 8 grams of borneol, 18 grams of smilax glabra, 20 grams of moneywort, 20 grams of banana buds, 20 grams of dandelion, 18 grams of coconut flower, 20 grams of isatis indigotica, 15 grams of coconut root, 20 grams of vaseline, 15 grams of lanolin, 15 grams of sodium carboxymethyl cellulose, 20 grams of glycerin, 3 grams of nano-borneol, 2 grams of microencapsulated menthol, and 1.5 grams of beta-tocopherol.

[0051] Example 3

[0052] A joint soothing and collateral unblocking compress comprises the following raw materials by weight: 10 grams of frankincense, 10 grams of myrrh, 15 grams of chuanxiong, 15 grams of angelica dahurica, 20 grams of smilax glabra, 20 grams of radix spatholobi, 15 grams of wormwood, 13 grams of safflower, 5 grams of borneol, 12 grams of smilax glabra, 15 grams of moneywort, 15 grams of banana buds, 15 grams of dandelion, 12 grams of coconut flower, 15 grams of isatis indigo leaf, 10 grams of coconut root, 15 grams of vaseline, 10 grams of lanolin, 10 grams of sodium carboxymethyl cellulose, 15 grams of glycerin, 2 grams of nano-borneol, 1.5 grams of microencapsulated menthol, and 1 gram of vitamin E acetate;

[0053] The above examples 1-3 adopt the following preparation method:

[0054] S1. Grind frankincense, myrrh, chuanxiong, angelica dahurica, smilax glabra, wormwood, safflower, airplane grass, money grass, banana bud, dandelion, coconut flower, and isatis indigotica separately, and pass through a 100-mesh sieve to obtain Chinese medicine powder;

[0055] S2, extracting frankincense, myrrh, chuanxiong, angelica dahurica, wormwood and borneol by supercritical CO2 extraction for 3 hours at a pressure of 25-30 MPa, a temperature of 40-45°C and a CO2 flow rate of 22 L / h to obtain a volatile oil extract;

[0056] S3, using microwave-assisted water extraction method on lycopodii, safflower, lycopodii, lycopodiella, banana bud, dandelion, coconut flower, isatis indigo leaf, and coconut root, with a solid-liquid ratio of 1:18, microwave power of 450 W, extraction temperature of 85 ° C, extraction twice, each time for 30 minutes, combining the extracts, and concentrating to a relative density of 1.13 to obtain a water extract concentrate;

[0057] S4, heating the matrix material to 63°C, adding the volatile oil extract of S2 and stirring until it becomes a colloid;

[0058] S5, slowly add the water extract concentrate obtained in S3 to the matrix mixture of S4, and emulsify at 7000rpm for 12 minutes, homogenize 3 times with a high-pressure homogenizer at a homogenization pressure of 60MPa to obtain a uniform and delicate milky matrix, cool to 42°C, add nano-borneol, and stir evenly;

[0059] S6. The preparation is formed by using microfluidic chip technology, with a channel width of 150 μm and a flow rate ratio of 3:1, to obtain a flexible patch with a porous structure, a porosity of 50%, and a pore size of 30 μm. The patch is packaged and sterilized to obtain the joint soothing and unblocking compress.

[0060] Comparative Example 1

[0061] The difference between this comparative example and Example 3 is that no nano-borneol is added to the raw materials.

[0062] Comparative Example 2

[0063] The difference between this comparative example and Example 3 is that no coconut flowers are added to the raw materials.

[0064] Comparative Example 3

[0065] The difference between this comparative example and Example 3 is that the frankincense and myrrh are not treated with vinegar roasting.

[0066] 1. Effect Verification

[0067] 1. Transdermal absorption experiment

[0068] 1.1 Skin preparation:

[0069] The abdominal skin of healthy rats was taken, subcutaneous fat was removed, and the skin was rinsed with PBS for later use.

[0070] The skin was fixed between the supply and receiving pools of the Franz diffusion cell, with an effective diffusion area of ​​1.77 cm 2 .

[0071] 1.2 Sample loading:

[0072] Apply the compress sample evenly on the skin surface (dose: 10 mg / cm 2 ).

[0073] PBS (pH 7.4) was added to the receiving cell, the temperature was maintained at 37±0.5°C, and the magnetic stirring speed was 300 rpm.

[0074] 1.3 Sampling and analysis:

[0075] 1 mL of sample was taken from the receiving pool at 0.5, 1, 2, 4, 6, 8, 12, and 24 h, and an equal amount of fresh PBS was added.

[0076] The concentration of active ingredients in the samples was determined by HPLC.

[0077] 1.4 Evaluation indicators

[0078] Transdermal rate (J):

[0079] Calculate the amount of active ingredient permeating per unit area of ​​skin per unit time (μg / (cm 2 h)).

[0080] Formula: J = (dQ / dt) / A

[0081] Wherein, dQ / dt is the rate of change of the transmittance with time, and A is the effective diffusion area.

[0082] 24-hour cumulative permeation (Q n ): Calculate the total amount of active ingredients permeated within 24 hours (μg / cm 2 ).

[0083] 1.5 Transdermal absorption test results

[0084]

[0085] The total active ingredient transdermal efficiency was increased by 2 times compared with traditional borneol (transdermal rate 4.2μg / (cm 2 h)).

[0086] 2. Pharmacodynamics Experiment

[0087] 2.1 Experimental Materials

[0088] Animal model: 50 SD rats (male, 200-250 g)

[0089] Modeling reagent: sodium monoiodoacetate (MIA)

[0090] Instruments and equipment: ELISA kit (to detect TNF-α, IL-1β), vernier caliper, joint flexion and extension angle measuring instrument.

[0091] 2.2 Experimental procedures

[0092] Model building:

[0093] The rat knee joints were injected with 50 μL of 3% MIA solution to induce osteoarthritis model.

[0094] Seven days after modeling, the mice were divided into the following groups: blank control group, model control group, and dressing treatment group (Examples 1-3).

[0095] Compress treatment group: apply the compress daily (6 hours / day) for 14 consecutive days.

[0096] Blank control group and model control group: no treatment was performed.

[0097] Index detection:

[0098] Joint swelling: The diameter of the knee joint was measured with a vernier caliper and the swelling (%) was calculated.

[0099] Serum inflammatory factors: blood was collected to separate serum, and ELISA was used to detect TNF-α and IL-1β levels.

[0100] Range of motion: The knee range of motion is assessed using an angulation meter.

[0101] 2.3 Evaluation indicators

[0102] Joint swelling reduction rate:

[0103] Formula: (swelling degree of model group - swelling degree of treatment group) / swelling degree of model group × 100%.

[0104] Changes in inflammatory factor levels:

[0105] The percentage decrease of TNF-α and IL-1β was calculated.

[0106] Improvement rate of joint range of motion:

[0107] Formula: (activity of treatment group - activity of model group) / activity of model group × 100%.

[0108] 2.4 Pharmacodynamic Experimental Results

[0109]

[0110] 3. Clinical application observation

[0111] 3.1 Trial Population

[0112] Inclusion criteria:

[0113] (1) Age range: 18-75 years old, regardless of gender.

[0114] (2) Patients diagnosed with osteoarthritis, rheumatoid arthritis or joint sprain, with a disease duration of ≥ 3 months.

[0115] (3) Joint pain VAS score ≥ 4 points (0-10 points).

[0116] (4) Voluntarily sign the informed consent form.

[0117] Exclusion criteria:

[0118] (1) Those who are allergic to the ingredients of the plaster.

[0119] (2) Patients with severe heart, liver, or kidney dysfunction.

[0120] (3) Those who have recently undergone joint surgery or intra-articular injection therapy.

[0121] (4) Pregnant or lactating women.

[0122] 3.2 Intervention measures

[0123] Method of using the dressing: The test group used the joint soothing and unblocking dressing of Example 3 of the present invention, and the control group used the placebo dressing. The dressing was evenly applied to the surface of the affected joint with a thickness of about 1 mm, and then covered with a breathable dressing, applied twice a day, once in the morning and once in the evening, and a course of treatment was 8 weeks of continuous use.

[0124] 3.3 Evaluation indicators

[0125] (1) Main efficacy indicators

[0126] Cure rate: After treatment, the VAS score of joint pain was ≤1 point, and the joint range of motion returned to normal (the difference compared with the healthy side was ≤10%).

[0127] Calculation formula: Cure rate = (number of cured cases / total number of cases) × 100%.

[0128] Effectiveness: After treatment, the VAS score of joint pain decreased by ≥50%, and the joint range of motion improved by ≥30%.

[0129] Calculation formula: Effective rate = (number of effective cases / total number of cases) × 100%.

[0130] (2) Secondary efficacy indicators

[0131] VAS score for joint pain:

[0132] Assessment method: Patients marked their pain intensity on a visual analogue scale (VAS) ranging from 0 to 10.

[0133] Evaluation time points: before treatment, 2 weeks of treatment, 4 weeks of treatment, and 4 weeks of follow-up.

[0134] Range of motion:

[0135] Evaluation method: Use a protractor to measure the flexion and extension angle of the affected side joint and compare it with the healthy side.

[0136] Evaluation time points: before treatment, 4 weeks of treatment, and 4 weeks of follow-up.

[0137] Quality of life rating:

[0138] Evaluation method: The SF-36 scale was used to evaluate the patients' quality of life.

[0139] Evaluation time points: before treatment, 4 weeks of treatment, and 4 weeks of follow-up.

[0140] 3.4 Clinical application observation results

[0141] index Treatment group (n=100) Control group (n=100) P-value Cure rate (%) 35 10 <0.001 Effectiveness (%) 75 40 <0.001 VAS score reduction (%) 65 30 <0.001 Improvement in joint range of motion (%) 50 10 <0.001

[0142] Experimental conclusion:

[0143] Significant therapeutic effect: The cure rate and effective rate of the treatment group were significantly higher than those of the control group (P<0.001), indicating that the compress has a significant therapeutic effect on joint pain and limited mobility.

[0144] Improved quality of life: The SF-36 score in the treatment group was significantly improved (P<0.001), indicating that the dressing can improve the quality of life of patients.

[0145] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A joint soothing and collateral unblocking compress, characterized in that: The invention comprises the following raw materials in parts by weight: 5-15 parts of frankincense, 5-15 parts of myrrh, 10-20 parts of chuanxiong, 10-20 parts of angelica dahurica, 15-25 parts of smilax glabra, 15-25 parts of radix spatholobi, 10-20 parts of wormwood, 8-18 parts of safflower, 2-8 parts of borneol, 8-18 parts of smilax glabra, 10-20 parts of moneywort, 10-20 parts of banana buds, 10-20 parts of dandelions, 8-18 parts of coconut flowers, 10-20 parts of isatis indigotica, 5-15 parts of coconut roots and 30-50 parts of matrix materials.

2. A joint soothing and collateral unblocking compress as claimed in claim 1, characterized in that: The matrix material is composed of the following components in parts by weight: 10-20 parts of vaseline, 5-15 parts of lanolin, 5-15 parts of sodium carboxymethyl cellulose and 10-20 parts of glycerol.

3. The joint soothing and collateral unblocking compress according to claim 1, characterized in that: The invention also contains synergistic ingredients: 1-3 parts of nano-borneol with a particle size of ≤100nm, 0.5-2 parts of microencapsulated menthol, and 0.5-1.5 parts of fat-soluble vitamin E derivatives. The encapsulation rate of the microencapsulated menthol is ≥90%.

4. A joint soothing and collateral unblocking compress as claimed in claim 3, characterized in that: The fat-soluble vitamin E derivative is selected from any one of α-tocopherol, β-tocopherol, α-tocotrienol and vitamin E acetate.

5. The joint soothing and collateral unblocking compress according to claim 1, characterized in that: The frankincense and myrrh are treated with vinegar roasting, and the specific method of the vinegar roasting treatment is: mix the frankincense and myrrh with rice vinegar in a weight ratio of 1: (0.1-0.3), stir well, and simmer for 1-3 hours, then stir over a low heat until the surface is slightly melted and a vinegar aroma escapes, then take out, cool, and dry.

6. The method for preparing the joint soothing and collateral unblocking compress according to claim 1, characterized in that: The following steps are involved: S1. Grind frankincense, myrrh, Chuanxiong, Angelica dahurica, Herba Lycopodii, Herba Artemisiae Argyi, Folium ... S2, extracting frankincense, myrrh, chuanxiong, angelica dahurica, wormwood leaf and borneol by supercritical CO2 extraction for 2-4 hours to obtain volatile oil extract; S3, using microwave-assisted water extraction method on lycopodii, safflower, lycopodii, lycopodiella, banana bud, dandelion, coconut flower, isatis indigo leaf, and coconut root, with a solid-liquid ratio of 1:15-20, extracting 1-3 times, each time for 20-40 minutes, combining the extracts, and concentrating to a relative density of 1.10-1.15 to obtain a water extract concentrate; S4, heating the matrix material to 60-65°C, adding the volatile oil extract of S2 and stirring until it becomes a colloid; S5, slowly add the water extract concentrate obtained in S3 to the matrix mixture of S4, and emulsify at a high speed of 5000-8000 rpm for 10-15 minutes, homogenize 2-3 times with a high-pressure homogenizer at a pressure of 50-80 MPa to obtain a uniform and delicate milky matrix, cool to 40-45°C, add nano-borneol, and stir evenly; S6. The preparation is formed by using microfluidic chip technology, with a channel width of 100-200 μm and a flow rate ratio of 3:1, to obtain a flexible patch with a porous structure, a porosity of 40-60%, and a pore size of 10-50 μm. After packaging and sterilization, the joint soothing and unblocking compress is obtained.

7. The method for preparing the joint soothing and collateral unblocking compress according to claim 5, characterized in that: The extraction conditions of S2 are: pressure 25-30MPa, temperature 40-45°C, CO2 flow rate 20-25L / h.

8. The method for preparing the joint soothing and collateral unblocking compress according to claim 5, characterized in that: The microwave power of S3 is 400-500W, and the extraction temperature is 80-90°C.

9. Use of the joint-soothing and unblocking compress according to any one of claims 1 to 5 in the preparation of a medicament for treating joint pain and diseases related to limited joint movement.

10. The use according to claim 9, characterized in that: The diseases related to joint pain and limited joint movement include rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, and joint sprains.

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