Composition for relieving joint or muscular pain including complex medicinal herbs extracts and method for manufacturing the same

Abstract

The present invention relates to a composition for relieving joint or muscle pain comprising a complex extract of herbal medicines, such as *Achyranthes root*, which is a natural medicine, as an active ingredient, and a method for manufacturing the same. The present invention is characterized by a safe composition of natural ingredients that relieves joint and muscle pain and is free from side effects such as allergies or anaphylaxis commonly found in conventional anti-inflammatory analgesics, and can be safely used by infants and pregnant women.

Description

Technology Field

[0001] The present invention relates to a composition for alleviating joint or muscle pain comprising a complex herbal extract, such as *Achyranthes root*, which is a natural medicinal product, as an active ingredient, and a method for manufacturing the same. More specifically, the invention relates to a composition for alleviating joint or muscle pain and a method for manufacturing the same, which is prepared as a cream formulation by mixing the complex herbal extract with other counter-irritants to enhance the effect of improving muscle pain and minimize the occurrence of skin troubles. Background Technology

[0002] As Korea enters an aging society, the number of patients suffering from degenerative arthritis and lower back pain is increasing every year. Furthermore, as pain itself is increasingly regarded as a disease, interest in this issue is higher than ever. Currently, the mainstream pain relievers available in the domestic market consist of anti-inflammatory drugs such as aspirin and Tylenol; morphine-based medications are used for severe pain, while other products like ketoprofen are sold in the form of creams or patches.

[0003] However, many topical pain relievers currently in use are generally unsatisfactory in terms of efficacy and cause some side effects. If taken in excessive doses, aspirin and Tylenol can cause toxicity to the stomach and liver, leading to disorders and inducing allergies. Furthermore, opioid analgesics such as morphine can cause severe addiction in patients, and non-steroidal anti-inflammatory drugs (NSAIDs) can cause various undesirable side effects such as nausea, vomiting, constipation, and blood clotting. Additionally, transdermal pain relievers, such as chemical creams or patches, can provide short-term pain relief but have the problem of irritating the skin.

[0004] Therefore, although many attempts are being made to develop transdermal pain relievers using natural herbal ingredients, there is a continuing need for research regarding the selection of effective herbal medicines, the effective extraction of active ingredients, formulations for optimizing skin absorption, and the minimization of effects on the skin.

[0006] Meanwhile, a pain-relieving composition containing tourmaline and a complex of natural ingredients (Korean Patent No. 2149954) discloses a composition containing tourmaline and a complex of natural ingredients such as dietary sulfur, licorice, purslane, and turmeric. However, there is a constant controversy regarding side effects such as the detection of radioactivity with respect to tourmaline, and many side effects such as vomiting, diarrhea, and headache have also been reported with respect to dietary sulfur (MSM). Therefore, there is an urgent need to develop a pain-relieving composition containing herbal ingredients that can be applied easily and conveniently at any time without concerns about side effects, as well as a formulation for easy skin absorption. Prior art literature

[0007] Korean Registered Patent No. 2149954 The problem to be solved

[0008] The object of the present invention is to provide a composition containing a herbal complex extract for relieving joint or muscle pain.

[0009] Another objective of the present invention is to provide a method for preparing a composition containing a herbal complex extract for relieving joint or muscle pain.

[0010] Another objective of the present invention is to provide a method for preparing a formulation that can be formulated by a composition containing a herbal complex extract for relieving joint or muscle pain.

[0011] The objectives of the present invention are not limited to those mentioned above, and other unmentioned objectives will be clearly understood from the description in detail. means of solving the problem

[0012] According to one aspect, the present invention provides a composition for relieving joint or muscle pain comprising a herbal complex extract, wherein, based on 100% by weight of the composition, the composition comprises 5-10% by weight of the herbal complex extract, 10-18% by weight of menthol, 2-8% by weight of camphor, 0.01-0.1% by weight of capsaicin, 15-35% by weight of an oily component, and 20-40% by weight of purified water.

[0013] The above-described herbal complex extract is composed of extracts of Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata, and is characterized by comprising, with respect to 100% by weight of the extract, 8-12% by weight of Achyranthes root extract, 30-35% by weight of Clematis root extract, 18-22% by weight of Eucommia bark extract, 8-12% by weight of Paeonia lactiflora extract, 7-10% by weight of Houttuynia cordata extract, and 15-20% by weight of Saposhnikovia divaricata extract. A composition for relieving joint or muscle pain is provided.

[0014] In addition, to put it differently, the mixing ratio of each ingredient constituting the above herbal complex extract is characterized as follows: Achyranthes root : Clematis root : Eucommia bark : Paeonia root : Houttuynia cordata : Saposhnikovia root = 1.0 : 2.0~4.0 : 1.5~2.5 : 0.5~1.5 : 0.5~1.0 : 1.2~2.0.

[0015] In addition, the above-mentioned oily component is one or more selected from the group consisting of liquid paraffin, beeswax, polysorbate 60, sorbitan sesquioleate, sorbitan stearate, glyceryl stearate, stearic acid, glyceryl stearate / PEG100, and propylene glycol, providing a composition for relieving joint or muscle pain.

[0016] According to another aspect, an anti-inflammatory analgesic comprising the above-mentioned composition for relieving joint or muscle pain is provided.

[0017] According to another aspect, the present invention comprises the steps of: (1) washing Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata; (2) chopping the Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata, and then infusing the entire herbal ingredients in 60% to 80% (v / v) ethanol at room temperature for 40 to 60 hours; (3) extracting the infused herbal ingredients in 60% to 80% (v / v) ethanol for 3 to 4 hours using a herbal decoction pot and filtering through a stainless steel mesh screen of 300 to 500 mesh to obtain a herbal complex extract; (4) preparing a gel formulation using a solution in which a thickening agent is dissolved from the filtered herbal complex extract; (5) preparing a cream formulation by dissolving menthol, camphor, and capsaicin in an oily component and then emulsifying it with an aqueous component such as a solution in which a thickening agent is dissolved. and (6) a method for preparing a composition for relieving joint or muscle pain, comprising the step of mixing the gel formulation and the cream formulation to prepare a final composition.

[0018] The thickening agent used in steps (4) and (5) above is not particularly limited to this, but is preferably one or more selected from the group consisting of xanthan gum, hydroxyethyl cellulose and carbomer, among which carbomer is most preferred.

[0019] In addition, when mixing the gel formulation and the cream formulation in step (6) above, the suitable ratio is preferably 3:7 to 5:5 by weight, and the ratio of 4:6 is most preferable. Effects of the invention

[0020] According to one embodiment, the composition containing a herbal complex extract of the present invention is composed mainly of natural ingredients, so it can provide a composition that can be safely used by pregnant women and others.

[0021] More specifically, the composition containing a complex herbal extract of the present invention alleviates joint and muscle pain and is a safe composition of natural ingredients that is free from side effects such as allergies or anaphylaxis commonly found in conventional anti-inflammatory analgesics, making it safe for use by infants and pregnant women.

[0022] According to one embodiment, the method for preparing a composition containing a herbal complex extract of the present invention is characterized by efficiently forming the herbal complex extract into a gel formulation so that the herbal complex extract is well mixed into a cream formulation containing a counter-irritant, and then mixing and homogenizing the gel formulation with the cream formulation. Brief explanation of the drawing

[0023] FIG. 1 is a flowchart schematically illustrating a method for preparing a composition containing a herbal complex extract according to one embodiment of the present invention. Figure 2 is a photograph schematically showing a method for preparing a composition containing a herbal complex extract according to one embodiment of the present invention. Figure 3 is a graph comparing the VAS values ​​of the experimental group and the control group according to the treatment date when treated with a composition containing a herbal complex extract according to one embodiment of the present invention. Figure 4 is a graph comparing the change in VAS of the experimental group and the control group according to the treatment date when treated with a composition containing a herbal complex extract according to one embodiment of the present invention. Figure 5 is a table showing the results of a general toxicity test conducted by the Korea Testing & Research Institute (KTR) on a composition prepared according to one embodiment of the present invention. Specific details for implementing the invention

[0024] The present invention will be described in detail below.

[0025] The present invention provides a safe and effective anti-inflammatory analgesic composition and a method for manufacturing the same by discovering a component effective for relieving joint and muscle pain from natural medicinal herbs, extracting the component, and including an effective amount of a counter-irritant in the extracted herbal complex extract.

[0026] While the inventors were trying to find a safe and effective anti-inflammatory analgesic composition for relieving joint and muscle pain, they discovered *Achyranthes root*, *Weilingxian*, *Duchang*, *Paeonia*, *Houttuynia cordata*, and *Saposhnikovia divaricata*, and found that by combining these in appropriate proportions, a composition exhibiting excellent anti-inflammatory analgesic effects can be obtained without the various major and minor side effects commonly found in opioid analgesics or NSAID analgesics.

[0027] In addition to the above-mentioned herbal complex ingredients, the present invention allows for further relief of pain by using counterirritants such as menthol, camphor, or capsaicin.

[0028] A composition according to one aspect of the present invention contains a herbal complex extract comprising Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata.

[0029] The above herbal complex extract is not limited to this, but it is most desirable in terms of effectiveness to combine Achyranthes root : Clematis root : Eucommia bark : Paeonia root : Houttuynia cordata : Saposhnikovia root as follows: 1.0 : 2.0~4.0 : 1.5~2.5 : 0.5~1.5 : 0.5~1.0 : 1.2~2.0.

[0030] That is, the composition for relieving joint or muscle pain comprising the herbal complex extract of the present invention comprises, based on 100% by weight of the total composition, 5-10% by weight of the herbal complex extract, 10-18% by weight of menthol, 2-8% by weight of camphor, 0.01-0.1% by weight of capsaicin, 15-35% by weight of an oily component, and 20-40% by weight of purified water. The Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata constituting the herbal complex extract comprise, based on 100% by weight of the herbal complex extract, 8-12% by weight of Achyranthes root extract, 30-35% by weight of Clematis root extract, 18-22% by weight of Eucommia bark extract, 8-12% by weight of Paeonia lactiflora extract, 7-10% by weight of Houttuynia cordata extract, and 15-20% by weight of Saposhnikovia divaricata extract.

[0031] Here, the efficacy of the numerous components used in the present invention is briefly examined as follows.

[0032] Achyranthes root is a member of the Amaranthaceae family. Achyranthes japonica It refers to the underground part of *Miq KAKAI*, and is known to have the effects of promoting blood circulation and regulating meridians by removing cold and dampness from the body and clearing joints, and to strengthen muscles and bones, thereby nourishing the liver and strengthening the kidneys. In the present invention, it is preferable that the *Miq KAKAI* be contained in an amount of 6 to 15% by weight based on 100% by weight of the herbal complex extract, and more preferable that it be contained in an amount of 8 to 12% by weight.

[0033] Wiryeongseon refers to the roots of Clematis and closely related species of the same genus, which grow in damp soil within thickets throughout Korea. It is a non-toxic herbal medicine that is generally harvested in the autumn, with the leaves, stems, and fibrous roots removed, washed thoroughly, sliced, and dried in the sun. In traditional Korean medicine, it has long been used for diseases accompanied by symptoms such as joint pain in the limbs, impaired joint movement, and paralysis of the hands and feet. It has been widely used as a miraculous remedy, particularly for treating cases where the lower back, knees, and legs are cold and painful, making it difficult to walk on the ground. Components known to exist in Clematis and closely related species include flavanone glycosides such as clematin, as well as saponins such as clemontanoside A–C and clematoside S; sugars and sterols are also known to be present. In the present invention, it is preferable that the above-mentioned Weilingxian be contained in an amount of 25 to 40% by weight based on 100% by weight of the herbal complex extract, and more preferable that it be contained in an amount of 30 to 35% by weight.

[0034] Eucommia is a species of Eucommia belonging to the genus Eucommia of the family Eucommiaceae. ulmoides It is the stem bark of *Oliv.* with the periderm removed. Pharmacological effects reported include hypotensive, anti-aging, cholesterol-lowering, anti-inflammatory, sedative, analgesic, immune modulatory, blood coagulation, uterine contraction, anti-allergic, and antibacterial effects. In the present invention, it is preferable that the above-mentioned *Du* be contained in an amount of 15 to 25% by weight based on 100% by weight of the herbal complex extract, and more preferable that it be contained in an amount of 18 to 22% by weight.

[0035] Peony is a perennial herbaceous plant belonging to the Ranunculaeae or Paeoniaceae families. Its flowers are primarily used for horticulture, and its stems and roots are known to possess medicinal effects such as sedation, analgesia, antispasmodic effects, anti-inflammatory properties, and prevention of stress-induced ulcers. In traditional Korean medicine, it is one of the highly sought-after medicinal plants, alongside ginseng, licorice, and Angelica gigas. In the present invention, it is preferable that the peony be contained in an amount of 6 to 15% by weight based on 100% by weight of the herbal complex extract, and more preferable that it be contained in an amount of 8 to 12% by weight.

[0036] Houttuynia cordata is a perennial herbaceous plant belonging to the Saururaceae family. According to the Compendium of Materia Medica, it is known to be effective for clearing heat, detoxification, diuresis, purulent treatment, and anti-inflammatory purposes. Clinically, it is applied to whooping cough, bronchitis, pneumonia, and tonsillitis, while in Korean traditional medicine, it is used for chronic skin diseases, diuresis, and anti-inflammatory purposes. It contains quercitrin as a major component, and recent studies have reported that Houttuynia cordata extract exhibits hypotensive, hypoglycemic, antibacterial, antiviral, anti-inflammatory, anti-allergic, and antioxidant effects. In the present invention, it is preferable that the Houttuynia cordata be contained in an amount of 5 to 12% by weight based on 100% by weight of the Korean traditional medicine complex extract, and more preferable that it be contained in an amount of 7 to 10% by weight.

[0037] Saposhnikovia divaricata is a new-blooming herb belonging to the Apiaceae family of the order Apiaceae in the order Apiaceae of dicotyledonous plants. Its main components are known to be coumarin-based substances such as imperatorin, psoralen, and bergapten. The roots of plants that do not produce flower stalks are harvested in spring and autumn, dried, and used as a medicinal herb. In traditional Korean medicine, it is used for purposes such as inducing sweating, fever reduction, pain relief, and antispasmodic effects. In the present invention, it is preferable that the Saposhnikovia divaricata be contained in an amount of 12 to 22% by weight based on 100% by weight of the herbal complex extract, and more preferable that it be contained in an amount of 15 to 20% by weight.

[0038] Using the above six herbal medicines, the herbs are washed and chopped, then soaked in water for about 48 hours, and subsequently extracted using an electric herbal decoction machine with 70% ethanol as a solvent for about 3 to 4 hours to obtain a herbal complex extract. It is desirable to repeat the soaking and extraction process once more using the residue remaining after extraction.

[0039] The above-mentioned herbal complex extract is mixed to a volume of 15 to 25% based on 100% of the volume of 0.5 to 1.0% carbomer solvent and prepared into a gel formulation using a homo mixer or the like.

[0040] Meanwhile, menthol, camphor, and capsaicin, which are used as counter-irritants in the composition, are dissolved in an oily component and purified water to form a cream formulation.

[0041] The herbal complex extract prepared in the gel formulation above and the mixture containing a counter-irritant prepared in the cream formulation above are mixed in a weight ratio of 3:7 to 5:5 and homogenized using a homogenizer mixer to complete the composition of the present invention, wherein the most preferred weight ratio is 4:6.

[0042] Figures 1 and 2 are a flowchart and a photograph schematically illustrating the method for preparing a composition containing a herbal complex extract according to the present invention.

[0043] Referring to FIGS. 1 and 2, a method for preparing a composition containing a herbal complex extract according to one embodiment of the present invention comprises: (1) a step of washing Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata (S100); (2) a step of cutting the Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata into small pieces, and then steeping the entire herbal material in 60% to 80% (v / v) ethanol at room temperature for 40 to 60 hours (S200); (3) a step of extracting the steeped herbal material in 60% to 80% (v / v) ethanol for 3 to 4 hours using a herbal decoction pot and filtering through a stainless steel mesh screen of 300 to 500 mesh to obtain a herbal complex extract (S300); (4) a step of preparing a gel formulation using a solution in which a thickening agent is dissolved in the filtered herbal complex extract (S400); (5) a step of preparing a cream formulation by dissolving menthol, camphor, and capsaicin in an oily component and then emulsifying it with an aqueous component such as a solution in which a thickener is dissolved (S500); and (6) a step of preparing a final composition by mixing the gel formulation and the cream formulation (S600).

[0044] The step of washing the above (1) Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata is a step of washing with water to remove any pesticides or foreign substances that may be present.

[0045] In addition, the step of cutting and extracting the above (2) herbal raw material is set as a condition to better extract the active ingredients, such as anti-inflammatory and analgesic components, contained in the herbal raw material. That is, the cut herbal raw material is preferably extracted with 60% to 80% (v / v) ethanol for 40 to 60 hours, and most preferably with 70% (v / v) ethanol for 48 hours.

[0046] In step (3) of extracting and filtering the above herbal raw material, when mixing the extraction solvent, it is most preferable to mix it in an amount of 8 to 10 times the weight of the dried herbal raw material. If the amount of purified water is less than 8 times, the extraction efficiency of active ingredients, etc. may decrease due to a lack of extraction solvent, and if the amount of purified water is more than 10 times, it may be inefficient in terms of economy. The above extraction solvent is preferably 70% (v / v) ethanol.

[0047] In addition, the temperature of ethanol extraction is most preferably 80-90℃. If the extraction temperature is below 80℃, the extraction efficiency of active ingredients may decrease, and if the extraction temperature exceeds 90℃, some of the active ingredients may be destroyed, which may not be desirable.

[0048] In addition, it is most desirable to perform ethanol extraction for 3 to 4 hours. If it is less than 3 hours, it may be somewhat insufficient in terms of extraction efficiency of active ingredients, etc., and if it exceeds 4 hours, it may be somewhat disadvantageous in terms of cost-effectiveness.

[0049] The above ethanol extraction conditions are optimized for the extraction efficiency of useful components from herbal raw materials through a synergistic effect resulting from the organic combination of ethanol ratio, temperature, and time.

[0050] In step (4) of preparing a herbal complex extract by extracting the above herbal raw material into a gel formulation, the solution in which the thickening agent mixed with the herbal complex extract is dissolved is not particularly limited to, but a carbomer solution of 0.5 to 1 weight% is preferred.

[0051] When mixing the above herbal complex extract and the above carbomer solution, it is desirable to add an appropriate amount of triethanolamine (TEA), etc., to raise the pH, although this is not specifically limited thereto.

[0052] In addition, in step (5) above, a counter-irritant such as menthol, camphor, and capsaicin is well dissolved in an oily component, and then emulsified with an aqueous component such as a 0.4 to 0.8 weight percent carbomer solution to prepare a cream formulation.

[0053] At this time, when emulsifying the above oily component and the above watery component, it is preferable to maintain the temperature at 60 to 80°C, although not specifically limited thereto, and most preferable to maintain it at 70°C. In addition, just as TEA, etc. was used to raise the pH in step (4), it is preferable to add a basic substance such as TEA to the oily component before emulsification in step (5).

[0054] Finally, the final composition can be obtained by mixing the gel formulation prepared in step (4) and the cream formulation prepared in step (5) together and homogenizing them with a homogenizer or the like. At this time, the mixing ratio of the gel formulation and the cream formulation is preferably 3:7 to 5:5 by weight, and the mixing ratio of 4:6 is most preferable.

[0056] The present invention will be explained in more detail below through the following examples. However, these examples are intended to illustrate the invention and the scope of the invention is not limited to these examples.

[0057] Examples

[0058] Example 1. Preparation of a composition containing a complex herbal extract

[0059] (1) Preparation of herbal complex extract

[0060] Using Achyranthes root, Clematis root, Eucommia bark, Paeonia bark, Houttuynia cordata, and Saposhnikovia divaricata purchased from the Yeongcheon Oriental Medicine Special Zone Distribution Complex, 70g of Achyranthes root, 210g of Clematis root, 140g of Eucommia bark, 70g of Paeonia bark, 52g of Houttuynia cordata, and 110g of Saposhnikovia divaricata were chopped using a Shinil mixer until the particles were about 1~2mm in size.

[0061] 652g of chopped medicinal herbs were steeped in 3L of 70% ethanol for 48 hours. Subsequently, the steeped solution was placed in an electric herbal medicine pot (Daewoo Co., DW-3000) and extracted for 3 hours at a temperature of 90℃. The volume of the first extraction was 1900mL, and 2L of 70% ethanol was added to the medicinal herb residue for a second steeping for 48 hours. The second steeped solution was placed in an electric herbal medicine pot under the same conditions as the first extraction and extracted; the volume of the second extraction was 1100mL, and the first and second extracts were combined to obtain 3L. The obtained 3L herbal extract was filtered through a 500-mesh stainless steel mesh.

[0062] The above 3L of filtered herbal extract was concentrated to 810mL using an evaporator (Eyela N-1000), and after concentration, it was used as a herbal complex extract. The concentration rate was 27%.

[0063] (2) Preparation of a gel formulation containing a complex herbal extract

[0064] 0.2 mL of triethanolamine (TEA) was added to 40 mL of the herbal complex extract obtained in 1, and then mixed with 200 mL of 0.9% carbomer solution (70°C).

[0065] The mixed solution was mixed at 3000 rpm using a homogenizer (TOPS HD-1000) to obtain a homogenized gel.

[0066] (3) Manufacture of cream formulations containing counter-irritants

[0067] a. Preparation of oil phase components

[0068] 100g of menthol (Heliosah), 40g of camphor (Duksan Pharmaceutical), and 1g of capsaicin (Jinsung Bio) were each weighed and placed into a 500mL beaker, and then 52g of liquid paraffin (World Green) and 22g of beeswax (Herb Nuri) were additionally added to the beaker, which was then placed in a constant temperature bath set at 80℃ and left to stand until completely dissolved. Next, 4g of polysorbate 60 (Lancasa), 1g of sorbitan sesquioleate (Lancasa), 3g of sorbitan stearate (Goldlevensa), 1.5g of glyceryl stearate (Goldlevensa), 4.5g of stearic acid (Yakuri Junyakusha), 3g of glyceryl stearate / PEG100 (Lancasa), and 18g of propylene glycol (Similac) were additionally added to the above-mentioned constant temperature bath and dissolved. After all were dissolved, 1mL of triethanolamine was added, and a pH test strip was used to check if the pH was weakly alkaline.

[0069] b. Preparation of aqueous components

[0070] 0.5g of carbomer was mixed with 105mL of distilled water, and then a temperature-controlled stirring device was set to 80℃ and 300rpm, and the mixture was stirred continuously until all of the carbomer was dissolved in the distilled water.

[0071] c. Oil painting

[0072] While mixing the aqueous component prepared in b above at 2000–3000 rpm using a homo mixer (TOPS, HD-1000), the oil component prepared in a above was poured into the beaker containing the aqueous component, and the rotation speed of the homo mixer was gradually increased to 6000 rpm. After confirming that emulsification had occurred, the homo mixer was stopped, and the emulsified cream formulation was continuously stirred. After the temperature dropped to around 50°C, 3.5 mL of phenoxyethanol (Hillion) was added as a preservative, and 1.75 mL of bisabolol and 1.75 mL of lemon-lime scent (Merimico) were additionally added as fragrances, and stirring was continued. The cream formulation cooled to room temperature was then used in the next experiment.

[0073] (4) Preparation of the final composition

[0074] 200 mL of the herbal complex extract gel formulation prepared in (2) above and 300 mL of the counter-irritant cream formulation prepared in (3) above were mixed, and then homogenized using a homo mixer to obtain the final composition.

[0076] Example 2. Results of a pain relief survey conducted on patients

[0077] A survey was conducted on 22 patients aged 35 to 65 suffering from joint and muscle pain, yielding the results shown in the table below. Among the patients, there were 10 male and 12 female patients, and the survey was conducted for two months from May to June 2023 on patients of Yeongcheon J Hospital.

[0078] Survey results on patients with joint and muscle pain Survey Survey content result 1 painful area Neck: 3 people Knees: 5 people Elbows: 5 people Shoulders: 4 people Waist: 4 people Wrists: 3 people Ankles: 3 people Thumb: 1 person 2 Time of drug administration May–June 2023 3 Correct number of times a day Round 1: 4 people Round 2: 11 people Round 3: 6 people Round 4: 1 person 4 Whether or not other painkillers are being taken Taking other painkillers: 2 people Not taking other painkillers: 20 people 5 Pain reduction effect No effect at all: 0 people Slight improvement but insignificant pain reduction: 6 people Clearly felt pain reduction: 12 people Satisfactorily improved: 4 people Pain completely gone: 0 people 6 Pain score (current pain level when initial pain was 10) 1: 1 person 2: 2 people 3: 3 people 4: 1 person 5: 5 people 6: 5 people 7: 4 people 8: 1 person 7 Presence or absence of side effects None at all: 21 people Skin rash: 1 person 8 Whether to continue using Will continue using: 21 people Will not use: 1 person

[0079] As shown in Table 1 above, it was found that the composition containing the herbal complex extract of the present invention exhibited a significant effect in relieving joint and muscle pain.

[0081] Example 3. Efficacy test of the composition of the present invention on patients with chronic shoulder pain

[0082] After confirming in Example 2 that the joint and muscle pain-relieving effect was significant, the efficacy of the composition of the present invention was further tested on patients with chronic shoulder pain at Daegu Jin Hospital, a hospital specializing in shoulder treatment. The efficacy of the composition according to the present invention was tested through VAS measurement. The Visual Analog Scale (VAS) is a test method for assessing a patient's pain level, consisting of a 10 cm line where one end is marked as "no pain" and the other end is marked as "the most severe pain imaginable." Patients record the pain they feel at the time of measurement on this line. Although this method cannot compare one patient with another, it has the advantage of being able to accurately determine how pain fluctuates within the same patient. The detailed conditions for testing other efficacy are as follows.

[0083] (1) Selection / Exclusion Criteria for Subjects

[0084] 1) Target diseases and indications: Patients with chronic shoulder pain

[0085] 2) Selection Criteria for Subjects

[0086] - Adults aged 20 or older and under 80

[0087] - People who have had unilateral shoulder pain for more than 3 months

[0088] - People who have not experienced a change in symptoms within the last month

[0089] - People who indicated 40mm or more on a 100mm VAS due to shoulder pain

[0090] - People who do not have any other areas of the body with pain more severe than shoulder pain

[0091] - Persons who voluntarily decided to participate in this clinical trial and gave written consent

[0092] 3) Subject Exclusion Criteria

[0093] - In cases of shoulder pain on both sides

[0094] - Shoulder pain resulting from trauma or spinal cord injury within the last 4 weeks

[0095] - Shoulder pain caused by inflammation or tumors

[0096] - When inflammatory arthritis, such as that caused by infectious or autoimmune diseases, is suspected during physical examination and diagnostic medical tests

[0097] - In cases where neurological disorders exist, such as symptoms of paralysis in local or generalized sensation

[0098] - Those for whom it is difficult to apply gel or cream to the affected area due to tattoos, unhealed wounds, etc.

[0099] - Pregnant women, breastfeeding mothers, and those planning to become pregnant

[0100] - Other individuals whom the clinical research manager deems unsuitable to participate in the study

[0101] (2) Test method

[0102] 1) Target number of subjects: Conducted a clinical study on a total of 30 subjects, consisting of 15 in the experimental group and 15 in the control group (placebo gel treatment group).

[0103] 2) 1st execution (1 st trial)

[0104] - Perform screening tests after subject selection and consent to participate

[0105] : Demographic information, vital signs, physical examination, history of diseases and surgeries, verification of past medication use, urine HCG pregnancy test (stick) for women of childbearing age, and performance of VAS evaluation

[0106] 3) 2nd execution (2 nd trial, proceeding simultaneously with the first trial)

[0107] - Pre-test baseline test

[0108] After randomization, perform a physical examination, vital signs, VAS, SPADI (Shoulder Pain and Disability Index), and NRS (Numeric Rating Scale).

[0109] - Usage of the composition of the present invention (apply twice a day, morning and evening)

[0110] - Training on pain note keeping (VAS check every morning after waking up and before applying the composition for 2 weeks)

[0111] 4) Interim check

[0112] One week after the start of the second phase, compliance, adverse events, and pain note completion were verified through a Q&A, and NRS measurements were taken.

[0113] 5) 3rd execution (3 rd trial)

[0114] - Evaluate adverse events and VAS, SPADI, and NRS 2 weeks (±3 days) after the second trial.

[0115] (3) Evaluation and Interpretation

[0116] Statistical analyses, such as Student's t-test or chi-square test, were performed on demographic data for each treatment group to verify randomization and the validity of subsequent analysis.

[0117] The primary efficacy endpoint, the second performance at the start of the study (2 nd The purpose is to demonstrate that the difference in the change of 100mm VAS at 2 weeks after the procedure between the experimental group using the composition of the present invention and the trial group is significantly superior to that of the control group. Therefore, the primary analysis method was to calculate a unilateral 97.5% confidence interval and show that the value (the lower limit of the two-sided 95% confidence interval) is greater than 0. At this time, Student's t-test or Wilcoxons rank sum test was performed for the confidence interval.

[0118] (4) Clinical trial results

[0119] 1) Patient Basic Information

[0120] The VAS values ​​for pain before treatment in the patients were 72.18±7.49 in the experimental group and 74.56±6.23 in the control group (Placebo gel treatment group), with no significant difference. In addition, there were no significant differences between the two groups in the distribution of left and right sides experiencing shoulder pain or in gender distribution. Furthermore, no significant differences were observed between the two groups in age, body weight, or height. This is shown in Table 2 below.

[0121] VAS value (mean ± standard deviation) experimental group control group Shoulder pain VAS value 72.18±7.49 74.56±6.23 Pain area (right / left) (9 / 6) (8 / 7) Gender (M / F) (6 / 9) (4 / 11) years 52.7±4.87 53.6±8.54 weight 65.38±5.11 62.12±6.37 height 163.36±5.62 160.68±6.29

[0122] 2) VAS values ​​of the experimental and control groups according to treatment date

[0123] The VAS for shoulder pain was 72.18±7.49 in the experimental group and 74.56±6.23 in the control group before treatment (Baseline). However, after 15 days, the results showed that the control group was 71.89±5.17, which was similar to the results before treatment, while the experimental group showed a significant decrease to 51.29±6.62. The VAS values ​​for shoulder pain according to the treatment date are listed in Table 3 below, and a graph of this is presented in Figure 3.

[0124] days VAS value (mean ± standard deviation) experimental group control group 0 72.18±7.49 74.56±6.23 1 71.29±8.56 74.50±9.63 2 70.69±7.62 73.89±8.46 3 69.84±8.32 73.98±7.53 4 66.67±8.10 71.33±6.48 5 67.31±8.84 72.62±7.34 6 64.88±7.74 71.01±10.28 7 64.51±9.24 71.64±8.87 8 63.34±7.15 72.74±9.11 9 60.63±8.11 70.48±6.12 10 57.46±8.14 71.55±7.47 11 56.66±10.56 72.17±6.66 12 54.17±9.98 69.51±7.35 13 53.64±10.33 70.98±6.28 14 52.22±7.85 71.77±7.11 15 51.29±6.62 71.89±5.17

[0125] 3) Changes in VAS, SPADI, and NRS values ​​of the experimental and control groups according to the treatment date

[0126] The change in VAS (before treatment–after treatment) was measured based on the VAS values ​​of shoulder pain measured by the patient daily using a pain notebook. In the control group, the change in VAS was 0.06±7.72 on day 1 and reached a peak of 5.05±8.68 on day 12. However, in the experimental group, it was 7.30±6.76 on day 6, 11.55±7.72 on day 9, 18.01±8.45 on day 12, and increased to 20.89±7.67 on day 15, indicating that the degree of pain decreased with the number of treatments.

[0127] When comparing the two groups based on treatment dates, it was found that the change in VAS was significantly higher in the experimental group than in the control group from day 6 to day 15. In other words, it was found that the experimental group significantly reduced the severity of shoulder pain compared to the control group starting from day 6.

[0128] It was found that the composition of the present invention continuously reduces pain, showing a superior therapeutic effect compared to the control group on the 6th day, and that this therapeutic effect continued to increase until the 15th day.

[0129] Regarding the improvement rate, the degree of shoulder pain in the control group decreased by a maximum of approximately 6.8% on the 12th day, whereas in the experimental group, the degree of pain decreased continuously with treatment, decreasing by approximately 16% on the 9th day and by approximately 29% on the 15th day compared to before treatment. The change in VAS values ​​of shoulder pain according to the treatment date is listed in Table 4 below, and a graph of this is presented in Figure 4. In addition, the change in SPADI and NRS values ​​for the experimental and control groups before and after treatment is listed in Table 5.

[0130] Days Change in VAS value (mean ± standard deviation) difference P-value experimental group control group 1 0.89±3.12 0.06±7.55 0.83 0.06 2 1.49±5.11 0.67±7.27 0.82 0.04 3 2.34±5.98 0.58±9.80 1.76 0.05 4 5.51±3.42 3.23±5.97 2.28 0.14 5 4.87±7.24 1.94±11.19 2.93 0.06 6 7.30±6.03 3.55±12.61 3.75 0.06 7 7.67±9.51 2.92±13.92 4.75 0.10 8 8.84±10.89 1.82±14.28 7.02 0.02 9 11.55±8.24 4.08±14.97 7.47 0.01 10 14.72±8.85 3.01±15.22 11.71 0.01 11 15.52±10.89 2.39±14.14 13.13 0.01 12 18.01±10.62 5.05±16.57 12.96 0.01 13 18.54±9.10 3.58±18.72 14.96 0.00 14 19.96±10.28 2.79±19.20 17.17 0.00 15 20.89±10.45 2.67±17.19 18.22 0.00

[0131] Before treatment After treatment difference P-value SPADI (experimental group) 18.72±19.23 11.12±16.26 7.60 <0.001 SPADI (control group) 17.44±15.68 18.67±16.63 -1.23 <0.001 NRS (experimental group) 4.95±1.79 2.48±2.02 2.47 <0.001 NRS (control group) 4.67±1.87 4.47±1.89 0.20 <0.001

[0132] As shown in Table 5 above, when measuring the change in pain before and after treatment over 2 weeks according to the SPADI (shoulder pain and disability index) value, the experimental group showed a difference of 7.60 in average value, indicating significant improvement, while the control group showed a difference of -1.23 in average value before and after treatment, indicating no treatment effect.

[0133] In addition, the change in the NRS (numeric rating scale) value for pain before and after treatment was 2.47, which was significantly higher than the 0.20 of the control group.

[0134] As can be seen from the results above, similar to the VAS values, it was found that the experimental group significantly improved shoulder pain and function compared to the control group in both SPADI and NRS.

[0135] The following exemplifies formulations that can be prepared using the external formulation composition of the present invention. It should be noted that formulations that can be formulated by the composition according to the present invention, including the cream formulation exemplified in Example 1 above, are not limited to the formulation examples below. In the following formulation examples, a mixed extract of *Achyranthes bidentata*, *Achyranthes japonica*, *Eucommia ulmoides*, *Paeonia lactiflora*, *Houttuynia cordata*, and *Saposhnikovia divaricata* is indicated as a "herbal extract," and counter-irritants are not included except in Formulation Example 2.

[0136] <Formulation Example 1>

[0137] Table 6 shows an example of a liquid extract formulation for a topical analgesic containing a mixed extract of *Achyranthes root*, *Achyranthes root*, *Eucommia bark*, *Paeonia root*, *Houttuynia cordata*, and *Saposhnikovia root* (Example 1-1).

[0138] number raw material Content (weight%) 1 herbal extracts 5.0 2 glycerin 3.0 3 Butylene glycol 2.0 4 Propylene glycol 2.0 5 Polyoxyethylene (60) hardened castor oil 1.0 6 ethanol 10.0 7 Triethanolamine 0.1 8 antiseptic a very small amount 9 pigment a very small amount 10 spices a very small amount 11 purified water Remaining amount

[0139] <Formulation Example 2>

[0140] An example of a lotion-type formulation containing a mixed extract of *Achyranthes bidentata*, *Achyranthes bidentata*, *Eucommia ulmoides*, *Paeonia lactiflora*, *Houttuynia cordata*, and *Saposhnikovia divaricata* (Example 1-1) is shown in Table 7.

[0141] number raw material Content (weight%) 1 herbal extracts 10.0 2 Beeswax 1.0 3 Polysorbate 60 1.5 4 Sorbitan sesquioleate 0.5 5 Liquid paraffin 10.0 6 Sorbitan stearate 1.0 7 lipophilic monostearic acid glycerin 0.5 8 stearic acid 1.5 9 Glyceryl Stearate / PEG-400 Stearate 1.0 10 Counter-irritants (menthol / camphor / capsaicin, etc.) 22.5 11 Propylene glycol 3.0 12 Carboxyvinyl polymer 0.1 13 Triethanolamine 0.2 14 antiseptic a very small amount 15 pigment a very small amount 16 spices a very small amount 17 purified water Remaining amount

[0142] <Formulation Example 3>

[0143] An essence-type formulation example containing a mixed extract of *Achyranthes bidentata*, *Achyranthes bidentata*, *Eucommia ulmoides*, *Paeonia lactiflora*, *Houttuynia cordata*, and *Saposhnikovia divaricata* (Example 1-1) is shown in Table 8.

[0144] number raw material Content (weight%) 1 herbal extracts 5.0 2 sitosterol 13.0 3 Polyglyceryl 2-oleate 0.2 4 Ceramide 0.1 5 Seteares-4 5.0 6 cholesterol 0.3 7 Dicetylphosphate a very small amount 8 Concentrated glycerin 1.0 9 Macadamia oil 0.2 10 Carboxyvinyl polymer a very small amount 11 Xanthan sword a very small amount 12 antiseptic a very small amount 13 spices a very small amount 14 purified water Remaining amount

[0145] As seen above, it can be seen that the composition of the present invention can be prepared in various different formulations. In the case of the counter-irritant, it may be included as in Formulation Example 2, or it may not be included as in Formulation Examples 1 and 3, but in either case, it is preferable to add an appropriate amount within the range where the counter-irritant dissolves.

[0147] As noted above, the herbal composition for pain relief according to the present invention provides the effect of pain relief by being applied to a muscle or joint area.

[0149] In addition, a general toxicity test was commissioned to the Korea Testing & Research Institute (KTR) for the herbal composition for pain relief according to the present invention, and the results showed that the pH was approximately 5.1, which is safe for application to the skin, and that it was safe in tests for heavy metals and microorganisms as well (see Fig. 5).

[0151] Accordingly, the present invention is a composition for relieving joint and muscle pain composed of natural herbal medicines, which can be safely used by pregnant women or children without side effects, and has significantly superior anti-inflammatory and pain-relieving effects compared to existing products, making it suitable for widespread use by modern people whose activity levels have increased since the COVID-19 pandemic.

[0153] Foregoing, specific parts of the present invention have been described in detail. It will be apparent to those skilled in the art that such specific descriptions are merely preferred embodiments and do not limit the scope of the invention. Accordingly, the actual scope of the invention is defined by the appended claims and their equivalents.

Claims

Claim 1 A composition for relieving joint or muscle pain comprising a herbal complex extract, wherein, based on 100% by weight of the composition, it comprises 5-10% by weight of the herbal complex extract, 10-18% by weight of menthol, 2-8% by weight of camphor, 0.01-0.1% by weight of capsaicin, 8-12% by weight of liquid paraffin, 3-7% by weight of beeswax, 2-10% by weight of an emulsifier, 2-6% by weight of a humectant, and the remainder being purified water to make the total composition 100% by weight; wherein the herbal complex extract is a mixed extract of Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata; wherein the emulsifier is one or more selected from the group consisting of polysorbate 60, sorbitan sesquioleate, sorbitan stearate, glyceryl stearate, stearic acid, and glyceryl stearate / PEG100; and wherein the humectant is propylene glycol. Or a composition for relieving muscle pain. Claim 2 A composition for relieving joint or muscle pain according to claim 1, characterized in that the mixing ratio of each medicinal herb constituting the herbal complex extract is, based on 1.0 part by weight of Achyranthes root, 2.0 to 4.0 parts by weight of Clematis root, 1.5 to 2.5 parts by weight of Eucommia bark, 0.5 to 1.5 parts by weight of Paeonia lactiflora, 0.5 to 1.0 parts by weight of Eoseongcho, and 1.2 to 2.0 parts by weight of Saposhnikovia divaricata. Claim 3 An anti-inflammatory and analgesic topical preparation comprising a composition for relieving joint or muscle pain as described in paragraph 1 or 2. Claim 4 A step of washing Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata; a step of mixing the above Achyranthes root, Clematis root, Eucommia bark, Paeonia lactiflora, Houttuynia cordata, and Saposhnikovia divaricata in the mixing ratio of claim 2, chopping them, and then steeping the entire herbal ingredients in 60% to 80% (v / v) ethanol at room temperature for 40 to 60 hours; a step of extracting the steeped herbal ingredients in 60% to 80% (v / v) ethanol for 3 to 4 hours using a herbal decoction pot and filtering through a stainless steel mesh screen of 300 to 500 mesh to obtain a herbal complex extract; and a step of preparing a gel formulation using a solution in which a thickening agent such as carbomer is dissolved in the filtered herbal complex extract. A method for preparing a composition for relieving joint or muscle pain, comprising the steps of: preparing an oil phase mixture by mixing and heating menthol, camphor, capsaicin, liquid paraffin, beeswax, and an emulsifier; preparing an aqueous phase mixture by mixing carbomer with purified water; preparing a cream formulation by emulsifying the oil phase mixture and the aqueous phase mixture; and preparing a final composition by mixing the gel formulation and the cream formulation. Claim 5 A method for preparing a composition for relieving joint or muscle pain according to claim 4, wherein the emulsifier is one or more selected from the group consisting of polysorbate 60, sorbitan sesquioleate, sorbitan stearate, glyceryl stearate, stearic acid, and glyceryl stearate / PEG100. Claim 6 A method for preparing a composition for relieving joint or muscle pain according to claim 4, wherein, in the step of preparing a final composition by mixing the gel formulation and the cream formulation, the ratio of mixing the gel formulation and the cream formulation is 3:7 to 5:5 by weight. Claim 7 delete Claim 8 delete

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