External composition for preventing and relieving joint discomfort and preparation method thereof

Abstract

The invention discloses an external composition for preventing and relieving joint discomfort. The external composition comprises a pseudo-ginseng extract, a radix ranunculi ternati extract, a geranium graciliforme extract, a safflower extract, a phryma leptostachya extract, an angelica root extract, a radix aconiti agrestis extract, a short-pedicel aconite root extract, an earthworm extract, a corydalis tuber extract, a rhizoma sparganii extract, an achyranthes root extract, a cinnamon extract, a morinda citrifolia extract and a loose knot extract. According to the traditional Chinese medicine composition disclosed by the invention, effective components are induced to directly reach uncomfortable parts of joints through respective channel tropism effects of the composition; symptoms such as numbness and pain can be quickly relieved, functions are adjusted, and rehabilitation is promoted; through test comparison of multiple patients, it is also verified that the external composition can well relieve and prevent the joint discomfort; and the test result has no toxic or side effect.

Description

Technical Field

[0001] The invention relates to a prescription for preventing and relieving joint discomfort, in particular to an external composition capable of preventing and relieving joint discomfort and a preparation method thereof. Background Art

[0002] Joints are an important part of the human body. They play a role in buffering force, bearing gravity, and supporting other pressures during limb movement. Protecting joints can not only improve athletic ability, but is also an important part of improving and maintaining the quality of life. As the connecting part between bones, joints help bones move within a certain range. They are mainly composed of bones, cartilage, tendons, synovium, joint capsules, muscles, synovial fluid and ligaments. Among them, cartilage is a connective fibrous tissue composed of water, collagen, proteoglycans (glucosamine and chondroitin) and chondrocytes. As the core component of the joint, cartilage can protect two adjacent bones from collision and reduce vibration and impact caused by movement. In addition, the synovium in the joint will also secrete synovial fluid, which can provide nutrition to the joint while keeping the cartilage surface lubricated, reducing friction and direct collision of the cartilage, and allowing the joint to move more flexibly.

[0003] Under normal circumstances, chondrocytes synthesize and secrete cartilage matrix such as collagen and proteoglycans to maintain the balance of the cartilage microenvironment, so that cartilage tissue has the ability to renew and repair, and delay cartilage aging. However, with age, the cartilage matrix produced by chondrocytes decreases, resulting in cartilage damage. At the same time, the loss of collagen, glucosamine and bone in the body accelerates, further reducing synovial fluid, increasing friction between joints, leading to poor joint movement, joint pain and discomfort, and even arthritis problems. In addition, excessive exercise intensity can cause excessive wear of joints and ligament damage, while long-term inactivity will hinder joint nutrition metabolism. Therefore, athletes, sports enthusiasts, houseworkers, workers, and office white-collar workers who sit for a long time are prone to joint discomfort and arthritis symptoms, which increase the burden on joints.

[0004] In addition, for obese people, excessive body weight will increase the pressure on joints during daily activities, which will change the biomechanics of the joints over time, causing the force on parts such as the knee and hip joints to be biased to one side or concentrated on certain points instead of being evenly distributed, resulting in excessive wear of the joints, causing pain and other discomfort, causing joint inflammation, and then leading to uncomfortable symptoms such as joint pain, swelling and stiffness.

[0005] And with the change of lifestyle, the number of arthritis patients is getting younger and younger. Inflammatory diseases are mainly caused by inflammation, infection, degeneration, trauma or other factors, and the clinical manifestations are redness, swelling, heat, pain, dysfunction and joint deformity of the joints.

[0006] As we age, the articular cartilage gradually wears and degenerates, and the structure and mechanical properties of the subchondral bone change, leading to increased friction between the joint surfaces and causing pain; long-term overuse or improper use of joints, such as high-intensity training of athletes and repetitive joint movements of manual laborers, can cause strain on the muscles and ligaments around the joints, decreased joint stability, and further pain; trauma such as fractures and sprains, if not completely healed, may leave behind joint pain problems; in addition, some diseases such as rheumatoid arthritis, osteoarthritis, gout and other autoimmune or metabolic diseases can lead to inflammatory reactions in the joints, and inflammatory factors stimulate nerve endings to produce pain signals.

[0007] In addition, TCM believes that the etiology and pathogenesis of joint pain are relatively complex, which can be summarized as follows: Invasion of three evils: wind, cold and dampness: This is a common cause of joint pain in TCM. Wind evil is prone to change and is easy to attack the yang position; cold evil is stagnant and easy to hurt the yang; damp evil is heavy and sticky, which is easy to block the qi mechanism. The three evils combine to invade the human body's skin surface, stay in the meridians and joints, resulting in poor circulation of qi and blood, which causes symptoms such as joint pain, swelling, and heaviness. In addition, if the patient has yang deficiency, or lives in a damp and cold environment, or wades in the rain, it is more likely to induce or aggravate joint pain. Liver and kidney deficiency: TCM believes that the liver governs the tendons and the kidneys govern the bones. If the liver and kidneys are insufficient, the tendons and bones will be malnourished, which can easily lead to joint pain and poor activity. Especially for middle-aged and elderly people, as they age, the liver and kidney functions gradually decline, and joint problems are more likely to occur. Insufficient qi and blood: Qi and blood are the power source of human life activities. Insufficient qi and blood will make it difficult to nourish the whole body, including the joints. Qi and blood deficiency can lead to joint malnutrition, pain, stiffness and other symptoms. In addition, insufficient qi and blood can also affect the body's defense ability, making the patient more vulnerable to external evil invasion.

[0008] At present, the treatment methods for joint pain include oral medication, physical therapy and topical medication. Oral medication mainly achieves the purpose of joint care by taking health products such as glucosamine, chondroitin and calcium orally, but due to the different absorption rates of health products by individual constitutions, the care effect brought by oral health products varies from person to person. For arthritis patients with more severe joint pain, some drugs or topical ointments containing anti-inflammatory and analgesic effects are used to relieve discomfort, which cannot fundamentally solve the problem of joint pain. Taking too much anti-inflammatory drugs often has side effects such as gastrointestinal irritation. Physical therapy usually requires professional equipment and venues, and its use is limited. Topical drugs have received widespread attention due to their advantages such as local effects and relatively small side effects. However, existing topical drugs still have deficiencies in efficacy and safety. Traditional Chinese medicine topical preparations are relatively slow to take effect, and although simple Western medicine topical drugs may take effect quickly, they are often poor in improving the overall function of joints and long-term effects.

[0009] Therefore, developing an advantageous topical composition has important clinical significance and market value. The present invention uses traditional Chinese herbal extracts as the main active ingredients, combines the characteristics of rapid external effect, and uses modern bioactive substances and transdermal technology to achieve "prevention instead of treatment" and maintain the healthy state of joints. Summary of the invention

[0010] In order to solve the above technical problems, the purpose of the present invention is to provide an external composition for preventing and relieving joint discomfort and a preparation method thereof, which can help improve joint sub-health problems and effectively relieve and eliminate uncomfortable symptoms such as numbness, swelling and pain in the joints.

[0011] In order to solve one of the above technical problems, the technical solution adopted is as follows: Provided is an external composition for preventing and relieving joint discomfort. The composition comprises: Panax notoginseng extract, cat's claw extract, geranium gracilis extract, safflower extract, radix schizonepetae extract, angelica root extract, aconite extract, Artemisia suspensa extract, earthworm extract, Corydalis yanhusuo extract, trillium extract, Achyranthes bidentata extract, cinnamon bark extract, Morinda citrifolia extract, pine knot extract, lycopodiella extract, Rhizoma Lulufen extract, chondroitin sodium sulfate, dimethyl sulfone, pepper extract, and ginger root extract.

[0012] After applying the composition of the present invention to the affected area, it will first dissolve in the lipids on the skin surface, and then pass through the stratum corneum by passive diffusion. The stratum corneum cells are full of lipids, and the composition molecules diffuse from the high-concentration skin surface to the low-concentration deep skin by concentration difference. After that, the composition will enter the active epidermis, and continue to diffuse by the principle of compatibility, and then be absorbed by the capillaries of the dermis to act on the local lesion site, thereby exerting the therapeutic effect of the composition to achieve the purpose of prevention, health care and symptom relief.

[0013] In the recipe: Panax notoginseng has the effects of removing blood stasis, stopping bleeding, promoting blood circulation and relieving pain; Cat's claw has the effects of detoxification, anti-inflammatory and dispersing stagnation; Slender Geranium can dispel rheumatism, dredge meridians, and treat rheumatic pain, numbness, cramps, and muscle and bone pain; Safflower has the effects of promoting blood circulation, relieving menstruation, dispersing blood stasis and relieving pain; Herba scutellariae and pine knots have the effects of dispelling wind and dampness, relaxing tendons and unblocking meridians, promoting blood circulation and relieving pain. They are often used for wind-cold-damp arthralgia and rheumatism. Angelica root has the effects of promoting blood circulation, relieving pain, and treating paralysis, carbuncle, ulcer, and traumatic injury. Aconitum kusnezoffii has the effects of treating wind-cold-dampness arthralgia, joint pain and anesthesia and analgesia; Earthworms are used to treat meridian blockage, poor blood circulation, and limb discomfort. They are suitable for treating hot arthralgia caused by red, swollen, and painful joints and difficulty in flexion and extension. Artemisia argyi has the functions of dispelling wind and dampness, dispersing blood stasis and relieving swelling, promoting blood circulation and relieving pain; Yanhusuo has the functions of promoting blood circulation, dispersing blood stasis, promoting qi and relieving pain, and is a traditional analgesic. Tripterygium wilfordii has the effects of breaking blood and promoting qi, eliminating stagnation and relieving pain; Cinnamon, according to Compendium of Materia Medica, can “strengthen the tendons and bones, unclog the blood vessels, and be suitable for guiding hundreds of medicines; Achyranthes bidentata contains a large amount of alkaloids, which can nourish the liver and kidney, strengthen the tendons and bones, and dredge the meridians. It is often used clinically to treat waist and knee pain and limb cramps caused by cold and dampness. Clinical pharmacology shows that Morinda citrifolia can maintain the normal functions of human cell tissues and enhance human immunity; Lycopodium, pharmacology shows that its supercritical extract has significant anti-inflammatory, analgesic, muscle-relaxing and blood-activating effects; Rhizoma Rhizoma Rhizoma has the effects of dispelling wind, activating collaterals and unblocking menstruation. It is mainly used to treat joint pain, numbness and spasm.

[0014] in; Chondroitin sulfate sodium is an acidic mucopolysaccharide present in human and animal cartilage tissue. It is mainly used to treat and prevent various cartilage-related joint diseases, such as osteoarthritis, knee meniscus injury and cartilage injury in other joints. It can promote cartilage repair, relieve joint pain and swelling, and improve joint function. It can improve cartilage diseases. Dimethyl sulfone has excellent permeability, which can help drugs penetrate human skin better and accelerate drug absorption. In addition, dimethyl sulfone also has certain anti-inflammatory and analgesic effects, and can be used to treat some inflammatory diseases and pain symptoms. It is generally widely used in the form of local medication to treat inflammatory diseases such as rheumatism and arthritis; Pepper extract: rich in alkaloids and volatile oils, it can promote the flow of phospholipid membranes and improve the absorption of active substances by cells; Ginger Root Extract: Rich in antioxidants, it helps fight free radicals and protect cells from damage, while also having anti-inflammatory properties that promote the disappearance of pain and swelling.

[0015] In order to better achieve the purpose of the invention, the present invention also has the following better solutions: In some embodiments, the topical composition for preventing and relieving joint discomfort of the present invention comprises the following parts by weight: 1 to 3 parts of Panax notoginseng extract, 2 to 4 parts of cat's claw extract, 2 to 4 parts of geranium gracilis extract, 1 to 3 parts of safflower extract, 1 to 3 parts of Herba schizonepetae extract, 2 to 4 parts of angelica root extract, 1 to 3 parts of Aconitum kusnezoffii extract, 1 to 3 parts of Artemisia selengensis extract, 1 to 3 parts of Pheretima extract, 1 to 3 parts of Corydalis yanhusuo extract, 1 to 3 parts of Tripterygium wilfordii extract, 2 to 4 parts of Achyranthes bidentata extract, 1 to 2 parts of cinnamon extract, 1 to 2 parts of Morinda officinalis extract, 1 to 2 parts of pine knot extract, 1 to 2 parts of Lycopodium album extract, 1 to 3 parts of Smilax glabra extract, 0.5 to 1.5 parts of chondroitin sodium sulfate, 0.5 to 1.5 parts of dimethyl sulfone, 0.5 to 1.5 parts of pepper extract, and 0.5 to 1.5 parts of ginger root extract.

[0016] The invention also comprises the following additives: 0.5 to 1.5 parts of magnesium aluminum silicate, 0.5 to 1.5 parts of sodium stearoyl glutamate, 0.5 to 1.5 parts of phospholipids and 0.5 to 1.5 parts of patchouli oil.

[0017] in; Magnesium aluminum silicate: helps form a stable formulation system, reduces the irritation of the formulation, and improves the skin feel of the formulation; Sodium stearoyl glutamate: improves the stability and extensibility of the preparation, stabilizes the preparation system, and helps maintain skin moisture; Patchouli oil has the effects and functions of clearing away heat and detoxifying, relieving itching, anti-inflammatory and analgesic; Phospholipids have functions and effects such as emulsification, cell activation, and information transmission. They are the main components of cell membranes and important active ingredients in the body.

[0018] In addition, the present invention also provides a method for preparing a topical composition for preventing and relieving joint discomfort, comprising the following steps: a. Weigh notoginseng extract, cat's claw extract, slender geranium extract, safflower extract, radix scutellariae extract, angelica root extract, aconite extract, Artemisia selengensis extract, earthworm extract, Corydalis extract, Tripterygium wilfordii extract, Achyranthes bidentata extract, cinnamon extract, Morinda citrifolia extract, pine knot extract, lycopodiella extract, Fructus Lulufen extract, Piper melongena extract, and ginger root extract in proportion, mix well, and dry under vacuum at 65-70° C. to obtain a mixture for standby use; b. Dissolve chondroitin sodium sulfate in purified water to prepare a chondroitin sodium sulfate solution with a pH value between 6 and 8; c. Dissolve dimethyl sulfone in purified water to obtain a dimethyl sulfone solution with a concentration of 75-80%; d. dissolving the phospholipid in an organic solvent to obtain a phospholipid solution; then subjecting the phospholipid solution to rotary evaporation to remove the organic reagent, and after a thin film is formed, adding a chondroitin sodium sulfate solution and a dimethyl sulfone solution to hydration to obtain a hydrated liquid; e. Add the above mixture into the hydrating liquid and stir, add patchouli oil, magnesium aluminum silicate and sodium stearoyl glutamate while stirring, and concentrate into an extract to obtain a topical composition for preventing and relieving joint discomfort.

[0019] In some embodiments, in order to better select materials and improve therapeutic effects, the phospholipids used are one or more of natural soybean lecithin, natural egg yolk lecithin or synthetic lecithin; the phospholipid organic solvent is a combination of one or more of ethanol, dichloromethane or acetone.

[0020] The external composition for preventing and relieving joint discomfort of the present invention has the characteristics of better prevention and relief of joint discomfort symptoms, inflammation and pain, high efficacy, and no toxic side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is one of the comparison diagrams of some patients before and after treatment in the embodiment of the present invention; Figure 2 This is the second comparison diagram of some patients before and after treatment in the embodiment of the present invention; Figure 3 This is the third comparison diagram of some patients before and after treatment in the embodiment of the present invention; Figure 4 This is the fourth comparison diagram of some patients before and after treatment in the embodiment of the present invention; Figure 5 This is the fifth comparison chart of some patients before and after treatment in the embodiment of the present invention; Figure 6 This is the sixth comparison chart of some patients before and after treatment in the embodiment of the present invention. DETAILED DESCRIPTION

[0022] The present invention is further described in detail below in conjunction with embodiments, and the embodiments are limited to provide a clearer understanding of the technical features, purposes and effects of the present invention.

[0023] Embodiment 1: The topical composition for preventing and relieving joint discomfort provided in this embodiment and its preparation method: First, weigh 2 parts of Panax notoginseng extract, 3 parts of cat's claw extract, 3 parts of slender Geranium extract, 2 parts of safflower extract, 2 parts of safflower extract, 2 parts of radix scutellariae extract, 3 parts of angelica root extract, 2 parts of Aconitum extract, 2 parts of Artemisia suspensa extract, 2 parts of Pheretima extract, 2 parts of Corydalis extract, 2 parts of Tripterygium wilfordii extract, 3 parts of Cyathula officinalis extract, 1.5 parts of cinnamon extract, 1.5 parts of Morinda citrifolia extract, 1.5 parts of pine knot extract, 1.5 parts of Lycopodium extract, 1.5 parts of Scutellaria baicalensis extract, 1 part of Piper methysticum extract, and 1 part of ginger root extract, mix well, and then vacuum dry at 65°C to obtain a mixture for standby use; Then, 1 part of chondroitin sodium sulfate is dissolved in purified water to prepare a chondroitin sodium sulfate solution with a pH value between 6; then, 1 part of dimethyl sulfone is dissolved in purified water to obtain a dimethyl sulfone solution with a concentration of 75%; 1 part of phospholipid is dissolved in 75% ethanol to obtain a phospholipid solution; then, the obtained phospholipid solution is subjected to rotary evaporation to remove the organic reagent, and after a thin film is formed, the chondroitin sodium sulfate solution and the dimethyl sulfone solution are added for hydration to obtain a hydrated liquid; Finally, the above-mentioned mixture is added into the hydrating liquid and stirred, and 1 part of patchouli oil, 1 part of magnesium aluminum silicate and 1 part of sodium stearoyl glutamate are added while stirring to concentrate into an extract, thereby obtaining the topical composition for preventing and relieving joint discomfort of the present application.

[0024] In the experimental comparison phase, we recruited 37 patients with varying degrees of joint discomfort as volunteers, including 17 males and 20 females, aged between 38 and 67 years old, with an average age of 48.4 years old; they met the diagnostic criteria for arthritis in the "Principles of Differential Diagnosis of Orthopedic Diseases"; they voluntarily participated in the study; and they complied with medical ethics requirements.

[0025] Exclusion criteria: patients with serious underlying diseases that may interfere with the evaluation of the trial results; patients who have undergone joint puncture, fluid extraction and injection within the past month; patients who have used other drugs that may interact with the trial drugs within the past month; patients with skin allergies or infections in the knee joints; pregnant or breastfeeding women, because the drugs may have adverse effects on the fetus or infant; patients who cannot comply with the requirements of the trial protocol.

[0026] Effective evaluation criteria: The TCM symptom score scale is used to check whether joint pain, swelling and other symptoms are relieved in arthritis drug trials. The efficacy evaluation criteria in the "Guidelines for Clinical Research of New TCM Drugs" are used. If the joint inflammation is not significantly improved or even worsens, it is ineffective; if the joint inflammation is improved and the pain and swelling are reduced, it is effective; if the joint inflammation is significantly improved or even completely disappears, it is markedly effective.

[0027] Recording and evaluation of adverse events: observe any discomfort experienced by patients after using the composition of the present invention, such as nausea, vomiting, rash, etc., to determine whether these adverse events are mild or severe, and whether there is a causal relationship with the composition.

[0028] Vital signs monitoring: Monitor the patient's temperature, blood pressure, heart rate, respiration and other basic vital signs to ensure that the composition does not have serious adverse effects on these basic physiological functions.

[0029] Total effective rate of treatment = (markedly effective + effective) cases / total number of cases × 100% In this test, 37 patients with joint discomfort were divided into an obesity compression group of 6 people, an exercise discomfort group of 11 people, a middle-aged group of 13 people, and a control group of 7 people according to the weight, age and cause of each patient. The test method is as follows: the obesity compression group, the exercise discomfort group, and the middle-aged group. These three groups applied the external composition of the first formula of this embodiment to the affected part once in the morning, noon and evening. After application, the affected part was rubbed until the epidermis felt burning. The use cycle was 21 days, and 3 cycles were required. The control group did not use the composition of the present invention, and uniformly used a certain brand of joint ointment on the market. The shortest course of the disease in the four groups of patients was 4 months, and the longest was 2 years.

[0030] The test results are as follows: Table 1 The comparison of clinical symptoms and signs before and after is as follows: Table 2 In summary, when the median value of the composition was taken, the 4 clinical symptoms and signs of the 4 groups after treatment were improved compared with those before treatment. After treatment, the scores of the joint pain degree and the number of joint tenderness in the treatment group were both lower than those in the control group, and the differences were significant. The treatment group was better than the control group in improving the joint pain degree and the number of joint tenderness. It can be seen that the topical composition of the present invention has a good therapeutic effect on the discomfort symptoms, inflammation, and pain of the joints; the cure rate is relatively high, and the test results have no toxic and side effects.

[0031] Embodiment 2: First, weigh 1 part of Panax notoginseng extract, 2 parts of cat's claw extract, 2 parts of geranium gracilis extract, 1 part of safflower extract, 1 part of radix schoenopraecises extract, 2 parts of angelica root extract, 1 part of Aconitum kusnezoffii extract, 1 part of Artemisia selengensis extract, 1 part of Pheretima extract, 1 part of Corydalis yanhusuo extract, 1 part of Tripterygium wilfordii extract, 2 parts of Achyranthes bidentata extract, 1 part of cinnamon extract, 1 part of Morinda officinalis extract, 1 part of pine knot extract, 1 part of Lycopodiella ciliata extract, 1 part of Smilax glabra extract, 0.5 parts of Piper mesenteriae extract, and 0.5 parts of ginger root extract; mix well, dry under vacuum at 68°C to obtain a mixture for later use.

[0032] Then, 0.5 parts of chondroitin sodium sulfate are dissolved in purified water to prepare a chondroitin sodium sulfate solution with a pH value between 7; then, 0.5 parts of dimethyl sulfone are dissolved in purified water to obtain a dimethyl sulfone solution with a concentration of 78%; 0.5 parts of phospholipids are dissolved in 75% ethanol to obtain a phospholipid solution; then, the obtained phospholipid solution is subjected to rotary evaporation to remove the organic reagent, and after a thin film is formed, the chondroitin sodium sulfate solution and the dimethyl sulfone solution are added for hydration to obtain a hydrated liquid; Finally, the above-mentioned mixture is added into the hydrating liquid and stirred, and 0.5 parts of patchouli oil, 0.5 parts of magnesium aluminum silicate, and 0.5 parts of sodium stearoyl glutamate are added while stirring to concentrate into an extract, thereby obtaining the topical composition for preventing and relieving joint discomfort of the present application.

[0033] In the comparative test here, we recruited 34 people with various joint discomforts as volunteers: aged 33 to 68 years old, including 18 males and 16 females, with an average age of 52.6 years old; they met the diagnostic criteria for arthritis in the "Principles of Differential Diagnosis of Orthopedic Diseases"; they voluntarily participated in the study; and they met the requirements of medical ethics.

[0034] Exclusion criteria: patients with serious underlying diseases that may interfere with the evaluation of the trial results; patients who have undergone joint puncture, fluid extraction and injection within the past month; patients who have used other drugs that may interact with the trial drugs within the past month; patients with skin allergies or infections in the knee joints; pregnant or breastfeeding women, because the drugs may have adverse effects on the fetus or infant; patients who cannot comply with the requirements of the trial protocol.

[0035] Effective evaluation criteria: The TCM symptom score scale is used to check whether joint pain, swelling and other symptoms are relieved in arthritis drug trials. The efficacy evaluation criteria in the "Guidelines for Clinical Research of New TCM Drugs" are used. If the joint inflammation is not significantly improved or even worsens, it is ineffective; if the joint inflammation is improved and the pain and swelling are reduced, it is effective; if the joint inflammation is significantly improved or even completely disappears, it is markedly effective.

[0036] Recording and evaluation of adverse events: observe any discomfort experienced by the patient after using the composition of the present invention, such as nausea, vomiting, rash, etc., to determine whether these adverse events are mild or severe, and whether there is a causal relationship with the composition. Vital sign monitoring: monitor the patient's basic vital signs such as body temperature, blood pressure, heart rate, respiration, etc. to ensure that the composition does not have a serious adverse effect on these basic physiological functions.

[0037] Total effective rate of treatment = (markedly effective + effective) cases / total number of cases × 100% In this test comparison, 34 volunteers were divided into the following groups according to the weight, age and cause of each patient: 7 people in the sports discomfort group, 11 people in the middle-aged and elderly group, 8 people in other groups, and 8 people in a control group. The test method was: the three treatment groups applied the topical composition of Example 2 to the affected area once in the morning, noon and evening. After application, the affected area was rubbed until the epidermis felt a burning sensation. 21 days was a use cycle, and 3 cycles were required. The control group did not use the composition of the present invention, but used a certain brand of joint ointment on the market. The shortest course of the disease in the four groups was 6 months, and the longest was 3 years. They were randomly divided into a control group and a treatment group. The groups were basically similar in gender, age and course of disease, with no significant differences, and were comparable. The results are as follows: Table 3 The comparison of clinical symptoms and signs before and after is as follows: Table 4 Referring to the above table, when the minimum amount of the composition is taken, the index parameters of the 4 clinical symptoms in the 4 groups before and after treatment are different from those in Example 1.

[0038] Embodiment 3: First, weigh 3 parts of Panax notoginseng extract, 4 parts of cat's claw extract, 4 parts of geranium gracilis extract, 3 parts of safflower extract, 3 parts of radix schoenopraeviae extract, 4 parts of angelica root extract, 3 parts of Aconitum kusnezoffii extract, 3 parts of Artemisia selengensis extract, 3 parts of Pheretima extract, 3 parts of Corydalis yanhusuo extract, 3 parts of Tripterygium wilfordii extract, 4 parts of Achyranthes bidentata extract, 2 parts of cinnamon extract, 2 parts of Morinda officinalis extract, 2 parts of pine knot extract, 2 parts of Lycopodium album extract, 3 parts of Smilax glabra extract, 0.5 parts of Piper mesenteriae extract, and 0.5 parts of ginger root extract; mix well, dry under vacuum at 70°C to obtain a mixture for later use.

[0039] Then, 1.5 parts of chondroitin sodium sulfate are dissolved in purified water to prepare a chondroitin sodium sulfate solution with a pH value between 8; then, 1.5 parts of dimethyl sulfone are dissolved in purified water to obtain a dimethyl sulfone solution with a concentration of 80%; 1.5 parts of phospholipids are dissolved in 75% ethanol or one or more of ethylenedichloromethane or acetone to obtain a phospholipid solution; then, the obtained phospholipid solution is subjected to rotary evaporation to remove the organic reagent, and after a thin film is formed, the chondroitin sodium sulfate solution and the dimethyl sulfone solution are added for hydration to obtain a hydrated liquid; Finally, the above-mentioned mixture is added into the hydrating liquid and stirred, and 1.5 parts of patchouli oil, 1.5 parts of magnesium aluminum silicate, and 1.5 parts of sodium stearoyl glutamate are added while stirring, and concentrated into an extract to obtain the topical composition for preventing and relieving joint discomfort of the present application.

[0040] In this trial, the volunteers were relatively old: aged 42 to 71 years old, a total of 36 people, including 19 males and 17 females, with an average age of 54.7 years old; they met the diagnostic criteria for arthritis in the "Principles of Differential Diagnosis of Orthopedic Diseases"; they voluntarily participated in the study; and they met the requirements of medical ethics.

[0041] Exclusion criteria: patients with serious underlying diseases that may interfere with the evaluation of the trial results; patients who have undergone joint puncture, fluid extraction and injection within the past month; patients who have used other drugs that may interact with the trial drugs within the past month; patients with skin allergies or infections in the knee joints; pregnant or breastfeeding women, because the drugs may have adverse effects on the fetus or infant; patients who cannot comply with the requirements of the trial protocol.

[0042] Effective evaluation criteria: The TCM symptom score scale is used to check whether joint pain, swelling and other symptoms are relieved in arthritis drug trials. The efficacy evaluation criteria in the "Guidelines for Clinical Research of New TCM Drugs" are used. If the joint inflammation is not significantly improved or even worsens, it is ineffective; if the joint inflammation is improved and the pain and swelling are reduced, it is effective; if the joint inflammation is significantly improved or even completely disappears, it is markedly effective.

[0043] Recording and evaluation of adverse events: observe any discomfort experienced by patients after using the composition of the present invention, such as nausea, vomiting, rash, etc., to determine whether these adverse events are mild or severe, and whether there is a causal relationship with the composition.

[0044] Vital signs monitoring: Monitor the patient's temperature, blood pressure, heart rate, respiration and other basic vital signs to ensure that the composition does not have serious adverse effects on these basic physiological functions.

[0045] Total effective rate of treatment = (markedly effective + effective) cases / total number of cases × 100% 36 volunteers were divided into a sports discomfort group of 9 people, a middle-aged and elderly group of 8 people, other groups of 10 people, and a control group of 9 people according to the weight, age and cause of each patient. The test method was as follows: the three treatment groups applied the topical composition for preventing and relieving joint discomfort of Example 3 to the affected area, once in the morning, noon and evening, and were required to rub the affected area until the epidermis felt a burning sensation. The use cycle was 21 days, and 3 cycles were required. The control group did not use the composition of the present invention, but uniformly used a certain brand of joint ointment on the market. The shortest course of the disease in the four groups of patients was 6 months, and the longest was 2.5 years. They were randomly divided into a control group and a treatment group. Each group was basically similar in terms of gender, age and course of disease. After statistical processing, there was no significant difference, and they were comparable. The test results are as follows: Table 5 The comparison of clinical symptoms and signs before and after is as follows: Table 6 Referring to the above table, when the highest value of the composition is taken, the 4 clinical symptoms and signs of the 4 groups before and after treatment are different from those of Examples 1 and 2. However, the composition with the composition as the main effective component has a good therapeutic effect on the discomfort symptoms, inflammation and pain of the joints. The composition of the present invention has a significant therapeutic effect on the treatment of discomfort symptoms, inflammation and pain of the joints, a high cure rate, and no toxic side effects of hormones.

[0046] like Figure 1-Figure 6 The figure shows the comparison of some of the treatments before and after the treatment of Examples 1 to 3. As can be seen from the figure, the situation after the test is much better than that before the test, and even has a better therapeutic effect.

[0047] The above are only some embodiments of the present invention. For those skilled in the art, several modifications and improvements can be made without departing from the creative concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. A composition for external use for preventing and relieving joint discomfort, characterized in that: The composition comprises: Panax notoginseng extract, cat's claw extract, geranium gracilis extract, safflower extract, radix spatholobi extract, angelica root extract, aconite extract, Artemisia suspensa extract, earthworm extract, Corydalis yanhusuo extract, trifoliate green extract, Achyranthes bidentata extract, cinnamon bark extract, Morinda citrifolia extract, pine knot extract, lycopodiella extract, Rhizoma Lulutongae extract, chondroitin sodium sulfate, dimethyl sulfone, pepper extract, ginger root extract.

2. The external composition for preventing and relieving joint discomfort according to claim 1, characterized in that The composition comprises the following parts by weight: 1 to 3 parts of Panax notoginseng extract, 2 to 4 parts of cat's claw extract, 2 to 4 parts of geranium gracilis extract, 1 to 3 parts of safflower extract, 1 to 3 parts of radix schoenopraecises extract, 2 to 4 parts of angelica root extract, 1 to 3 parts of Aconitum kusnezoffii extract, 1 to 3 parts of Artemisia suspensa extract, 1 to 3 parts of Pheretima extract, 1 to 3 parts of Corydalis yanhusuo extract, 1 to 3 parts of Tripterygium wilfordii extract, 2 to 4 parts of Achyranthes bidentata extract, 1 to 2 parts of cinnamon bark extract, 1 to 2 parts of Morinda citrifolia extract, 1 to 2 parts of pine knot extract, 1 to 2 parts of Lycopodium album extract, 1 to 3 parts of Fructus Smilacis Glabrae extract, 0.5 to 1.5 parts of chondroitin sodium sulfate, 0.5 to 1.5 parts of dimethyl sulfone, 0.5 to 1.5 parts of pepper extract, and 0.5 to 1.5 parts of ginger root extract.

3. The external composition for preventing and relieving joint discomfort according to claim 1 or 2, characterized in that: The invention also comprises the following additives: 0.5 to 1.5 parts of magnesium aluminum silicate, 0.5 to 1.5 parts of sodium stearoyl glutamate, 0.5 to 1.5 parts of phospholipids and 0.5 to 1.5 parts of patchouli oil.

4. The method for preparing the external composition for preventing and relieving joint discomfort according to claim 3, characterized in that , the preparation method comprises the following steps: a. Weigh notoginseng extract, cat's claw extract, slender geranium extract, safflower extract, radix scutellariae extract, angelica root extract, aconite extract, Artemisia selengensis extract, earthworm extract, Corydalis extract, Tripterygium wilfordii extract, Achyranthes bidentata extract, cinnamon extract, Morinda citrifolia extract, pine knot extract, lycopodiella extract, Fructus Lulufen extract, Piper melongena extract, and ginger root extract in proportion, mix well, and dry under vacuum at 65-70° C. to obtain a mixture for standby use; b. Dissolve chondroitin sodium sulfate in purified water to prepare a chondroitin sodium sulfate solution with a pH value between 6 and 8; c. Dissolve dimethyl sulfone in purified water to obtain a dimethyl sulfone solution with a concentration of 75-80%; d. dissolving the phospholipid in an organic solvent to obtain a phospholipid solution; then subjecting the phospholipid solution to rotary evaporation to remove the organic reagent, and after a thin film is formed, adding a chondroitin sodium sulfate solution and a dimethyl sulfone solution to hydration to obtain a hydrated liquid; e. Add the above mixture into the hydrating liquid and stir, add patchouli oil, magnesium aluminum silicate and sodium stearoyl glutamate while stirring, and concentrate into an extract to obtain a topical composition for preventing and relieving joint discomfort.

5. The method for preparing the external composition for preventing and relieving joint discomfort according to claim 4, characterized in that , the phospholipid is one or more of natural soybean lecithin, natural egg yolk lecithin or synthetic lecithin.

6. The method for preparing the external composition for preventing and relieving joint discomfort according to claim 4, characterized in that , the phospholipid organic solvent is a combination of one or more of ethanol, dichloromethane or acetone.

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