A pharmaceutical composition for relieving pain, its preparation method and its application

Abstract

This invention relates to a highly effective pain-relieving pharmaceutical composition, comprising, by weight, 10-30 parts of Angelica sinensis, 10-30 parts of Chaenomeles speciosa, 10-30 parts of Paeonia lactiflora, 10-30 parts of Boswellia carterii, 10-30 parts of Eupolyphaga sinensis, 5-20 parts of Sappanwood, 5-20 parts of Carthamus tinctorius, 0.1-5 parts of Dracaena cochinchinensis, 5-20 parts of Syzygium aromaticum, 20-40 parts of Hibiscus mutabilis leaf, 20-40 parts of Citrus aurantium, 10-25 parts of Commiphora myrrha, and 20-40 parts of calcined natural copper. The pharmaceutical composition of this invention has advantages such as rapid onset of action, high therapeutic efficacy (≥96%), high significant efficacy (≥65%), low recurrence rate, prolonged recurrence interval, safety and effectiveness, and good patient compliance.

Description

Technical Field

[0001] This invention belongs to the field of biomedicine, specifically relating to a pharmaceutical composition for relieving pain, its preparation method, and its application. Background Technology

[0002] Various acute injuries, chronic strains, and invasion of wind, cold, and dampness can all cause pathological damage and pain in the skin, subcutaneous fascia, muscles, tendons, ligaments, joint capsules, and intervertebral discs. The etiology and pathogenesis mainly include stagnation of qi and blood due to trauma or strain, resulting in poor circulation and pain. Local pain in the later stages of fractures, dislocations, and soft tissue injuries is a common orthopedic condition, often caused by damage to the meridians and qi and blood, and poor circulation due to trauma or chronic strain. Neck, shoulder, back, and leg pain, osteoarthritis, and myofascitis are mainly characterized by pain in the affected area, limited mobility, and difficulty in flexion and extension. The pain and limited mobility progressively worsen, seriously affecting the patient's health and quality of life. In severe cases, patients may eventually lose their ability to work, and some may require surgery, placing a significant financial burden on patients and their families.

[0003] Non-surgical treatments for orthopedic diseases and their associated pain primarily involve physical therapy and medication. Physical therapies include acupuncture, heat therapy, shortwave diathermy, and electromagnetic wave therapy, but these have drawbacks such as limited effectiveness, long treatment durations, and poor patient compliance. Medications include the use of nonsteroidal anti-inflammatory drugs (NSAIDs) (such as celecoxib, ibuprofen, indomethacin, and diclofenac diethylamine emulsion ointment) to relieve pain, the use of glucosamine sulfate and chondroitin sulfate to slow the progression of joint degeneration, intra-articular and local injections of sodium hyaluronate, lidocaine, and corticosteroids, as well as the use of neurotrophic drugs, cytokines, and gene regulation therapies. However, these methods suffer from slow onset of action, long treatment durations, risks of joint infection, gastrointestinal, central nervous system, kidney, and allergic reactions, high recurrence rates, and short recurrence intervals. Therefore, there is an urgent need to develop safe and effective pain-relieving drug combinations to meet clinical needs. Summary of the Invention

[0004] The purpose of this invention is to provide a pharmaceutical composition for relieving pain, comprising, by weight, 10-30 parts of Angelica sinensis, 10-30 parts of Chaenomeles speciosa, 10-30 parts of Paeonia lactiflora, 10-30 parts of Boswellia carterii, 10-30 parts of Eupolyphaga sinensis, 5-20 parts of Sappanwood, 5-20 parts of Carthamus tinctorius, 0.1-5 parts of Dracaena cochinchinensis, 5-20 parts of Syzygium aromaticum, 20-40 parts of Hibiscus mutabilis leaf, 20-40 parts of Citrus aurantium, 10-25 parts of Commiphora myrrha, and 20-40 parts of calcined natural copper.

[0005] The preferred embodiment of the present invention, by weight, comprises 15-25 parts of Angelica sinensis, 15-25 parts of Chaenomeles speciosa, 15-25 parts of Paeonia lactiflora, 15-25 parts of Boswellia carterii, 15-25 parts of Eupolyphaga sinensis, 8-15 parts of Sappanwood, 8-15 parts of Carthamus tinctorius, 0.5-3 parts of Dracaena cochinchinensis, 8-15 parts of Syzygium aromaticum, 25-35 parts of Hibiscus mutabilis leaf, 25-35 parts of Citrus aurantium, 15-20 parts of Commiphora myrrha, and 25-35 parts of calcined natural copper.

[0006] The preferred embodiment of the present invention, by weight, comprises 20 parts of Angelica sinensis, 20 parts of papaya, 20 parts of Paeonia lactiflora, 20 parts of frankincense, 20 parts of Eupolyphaga sinensis, 10 parts of Sappanwood, 10 parts of Carthamus tinctorius, 1 part of Dragon's Blood, 10 parts of clove, 30 parts of Hibiscus mutabilis leaf, 30 parts of Osmanthus fragrans, 18 parts of myrrh, and 30 parts of calcined natural copper.

[0007] The preferred embodiment of the present invention, by weight, comprises 15 parts of Angelica sinensis, 15 parts of papaya, 15 parts of Paeonia lactiflora, 15 parts of frankincense, 15 parts of Eupolyphaga sinensis, 5 parts of Sappanwood, 5 parts of Carthamus tinctorius, 1 part of Dragon's Blood, 5 parts of Clove, 20 parts of Hibiscus mutabilis leaf, 10 parts of Golden Fruit Olive, 15 parts of Myrrh, and 20 parts of Calcined Natural Copper.

[0008] The preferred embodiment of the present invention, by weight, comprises 30 parts of Angelica sinensis, 30 parts of papaya, 30 parts of Paeonia lactiflora, 30 parts of frankincense, 20 parts of Eupolyphaga sinensis, 10 parts of Sappanwood, 10 parts of safflower, 1 part of dragon's blood, 10 parts of clove, 30 parts of Hibiscus mutabilis leaf, 30 parts of golden elm, 18 parts of myrrh, and 30 parts of calcined natural copper.

[0009] This invention employs a scientifically formulated drug composition based on the principle of syndrome differentiation and treatment. It utilizes the blood-tonifying and blood-activating properties of Angelica sinensis, synergistically combining components such as Paeonia lactiflora, Chaenomeles speciosa, Carthamus tinctorius, and Sappanwood, which have the effects of activating blood circulation, removing blood stasis, relaxing muscles and tendons, relieving pain, promoting blood circulation, relaxing muscles and tendons, dispersing blood stasis, promoting qi and blood flow, relaxing muscles and tendons, and dispersing blood stasis. It also synergistically utilizes components such as Frankincense, Myrrh, Eupolyphaga sinensis, Dragon's Blood, Hibiscus mutabilis leaf, Golden Fruit, and Calcined Natural Copper, which have the effects of activating blood circulation, relieving pain, breaking up blood stasis, softening and dispersing nodules, cooling blood and reducing swelling, promoting blood circulation, reconnecting bones and tendons, dispelling wind and dampness, and relieving cold and pain. This effectively prevents and treats muscle agglomeration and stiffness, significantly improving symptoms such as soft tissue injury, muscle agglomeration and stiffness, chronic strain in the neck, shoulders, waist, and legs, and residual pain or discomfort after injury. It has advantages such as rapid onset of action, high treatment efficacy, low recurrence rate, prolonged recurrence interval, easy preparation, convenient use, safety and effectiveness, and good patient compliance.

[0010] Angelica sinensis is known as the "holy medicine for blood disorders," a qi-regulating herb within the blood, possessing comprehensive benefits. It harmonizes, nourishes, invigorates, and relieves pain, ensuring sufficient qi and blood, promoting blood circulation, and aiding in the dispersal of blood stasis and hardened masses. The *Ben Cao Zheng Yi* states, "The body of Angelica sinensis primarily guards and nourishes, its efficacy is inherent; the tail primarily unblocks, its ability to dispel blood stasis is evident." The *Lei Gong Pao Zhi Yao Xing Lun* also states, "The head of Angelica sinensis stops bleeding and ascends; the body nourishes and guards the center; the tip breaks up blood stasis and flows downwards; the whole root invigorates blood without dispersing."

[0011] Red peony root is the dried root of *Paeonia lactiflora* or *Paeonia veitchii*, belonging to the Ranunculaceae family. It is harvested in spring and autumn, and after removing the rhizomes, fibrous roots, and dirt, it is sun-dried. It is bitter and slightly cold in nature, and enters the liver meridian. It can invigorate qi and promote blood circulation, break up blood stasis and disperse stagnant blood, and smooth blood vessels. The *Compendium of Materia Medica* records, "Red peony root and white peony root have similar main indications… Red peony root has the effect of dispelling pathogens and promoting blood circulation… Red peony root can activate blood circulation… Using this can cool the blood and remove blood stasis."

[0012] Papaya is the dried, nearly mature fruit of the Chaenomeles speciosa plant (Rosaceae family). It is warm in nature, sour in taste, and enters the liver and spleen meridians. Its function is to relax muscles and tendons, and it also helps to resolve dampness. It is an essential medicine for those suffering from muscle spasms, and can treat muscle cramps, damp-heat-related muscle spasms, and soreness and pain in the lower back and knees. When the muscles and tendons are affected, papaya can soothe the liver and spleen, and relax the muscles and tendons. The *Compendium of Materia Medica* describes papaya as "a product that enters the liver and benefits the muscles, and a flavor that nourishes the blood and protects the blood vessels."

[0013] Safflower possesses a pungent, warming, and invigorating nature, which can promote blood circulation, remove blood stasis, and regulate the meridians; it excels at promoting blood circulation, especially removing blood stasis, and treating blood stasis syndromes such as external injuries and chronic diseases.

[0014] Sappanwood invigorates blood circulation, promotes menstruation, removes blood stasis, relieves pain, and can promote the movement of accumulated blood. Small amounts can invigorate and nourish blood, while large amounts can break up blood stasis and eliminate masses.

[0015] Frankincense is pungent, aromatic, and warming, and has the effects of promoting blood circulation, removing blood stasis, relieving pain, promoting blood circulation and relaxing muscles, regulating qi and relieving stagnation, reducing swelling and promoting tissue regeneration. It can also help the penetration of external medicines.

[0016] Myrrh is primarily used to break up lumps and stagnant blood, relieve pain, reduce swelling, and promote tissue regeneration. It is excellent at invigorating blood circulation and is an essential medicine in external trauma treatment, commonly used to treat various pains caused by internal and external blood stasis, as well as carbuncles and swellings. The *Lei Gong's Explanation of the Properties of Processed Medicinal Herbs* states: "Myrrh and frankincense have similar effects. Generally, when blood stagnates, qi becomes congested; when qi becomes congested, the meridians become full and tight, hence the pain and swelling. Myrrh helps to promote the flow of qi and blood, thus its therapeutic effect is appropriate."

[0017] Ground beetle (also known as earth beetle or ground beetle) has the effects of resolving blood stasis, breaking up masses, and repairing injuries. It is used for various types of injuries, and is effective in treating fractures and tendon injuries in the later stages when tendons and bones are weak and powerless. It has the effects of promoting tendon and bone healing, relieving pain and treating injuries.

[0018] Dragon's blood is sweet and salty in taste, neutral in nature, and enters the heart and liver meridians. It softens hardened masses and promotes blood circulation, relieving pain and promoting blood flow. It is used to treat various blood stasis symptoms caused by falls and injuries. The *Yuqiu Yaoxie* states, "Dragon's blood breaks up blood stasis, and is effective for masses, lumps, and stagnant blood from falls. It breaks up blood stasis, promotes blood circulation, relieves pain, and helps heal injuries." Dragon's blood can also be used for external bleeding and slow-healing ulcers, having hemostatic and tissue-regenerating effects.

[0019] Hibiscus leaves (wood) are neutral in nature and pungent in taste. They have the effects of cooling the blood, detoxifying, reducing swelling, and relieving pain. For external use, they are suitable for carbuncles, boils, burns, and injuries from falls and blows. The Yuqiu Materia Medica states: "Hibiscus has the effect of clearing heat and dispersing stagnation, and is good at eliminating swelling and toxins. It has a great effect on all kinds of sores and ulcers, and is good for both topical application and oral administration."

[0020] Golden olive is the dried tuberous root of the plant *Gnaphalium affine*. It is a bitter and cold herb with the functions of clearing heat, detoxifying, and relieving pain. It can be used for various carbuncles, boils, and sores. The *Pharmacopoeia* records its external use as follows: "For carbuncles, boils on the back, red boils, and snake, scorpion, and insect bites, grind and apply."

[0021] Calcined copper, which is prone to spontaneous combustion, disperses blood stasis, relieves pain, promotes bone healing, repairs injuries, and reduces swelling. It is used for fractures caused by falls, blood stasis, swelling, and pain. Its ability to promote blood circulation, remove blood stasis, and relieve pain makes it an essential medicine in traumatology.

[0022] The pharmaceutical composition of this invention utilizes the blood-activating, blood-circulating, blood-stasis-removing, and pain-relieving effects of frankincense and myrrh, promoting the flow of qi and blood and enhancing the efficacy of the medicine. It also utilizes the blood-activating properties of earthworm and dragon's blood, specifically targeting masses and stasis, softening hardened masses, removing chronic blood stasis, and promoting blood circulation and muscle relaxation. Furthermore, it utilizes the cooling, blood-clearing, heat-inducing, and heat-dispersing effects of hibiscus leaf and golden elm, making the overall formula more balanced and harmonious. Calcined natural copper is a key medicine for treating injuries and promoting healing. Even in cases of chronic injuries, though not fractures or severed tendons, prolonged lack of nourishment inevitably leads to bone and tendon damage; therefore, natural copper and earthworm are also used to treat injuries and relieve pain. This composition not only assists the principal and assistant herbs in activating blood circulation, relaxing muscles and removing blood stasis, but also strengthens the effects of breaking up masses and softening hardened masses, repairing injuries and promoting healing for chronic injuries, while paying attention to the harmony of the medicinal properties and protecting the skin when applied externally. Clove, with its pungent, warm, and dispersing properties, warms and invigorates yang, helping the other herbs to reach the affected area.

[0023] The preferred technical solution of the present invention is to weigh the required amount of components, mix them evenly, and grind them into a fine powder of the pharmaceutical composition, thereby obtaining the product. The preferred fine powder of the pharmaceutical composition is 150-200 mesh.

[0024] In a preferred embodiment of the present invention, the prepared pharmaceutical composition powder is mixed with a solvent to form an ointment or paste before use. The ointment or paste is then applied to the patient's painful or affected area, and massaged for 3-5 minutes using any one or a combination of gentle rubbing, pushing, or palm kneading techniques. The medicine is then covered with a transparent film for 15-20 minutes, once a day, for 20-30 minutes each time. The solvent is selected from any one of water, ginger juice, vinegar, or white wine.

[0025] In a preferred embodiment of the present invention, the mass-to-volume ratio of the pharmaceutical composition fine powder to the solvent is 1:10-20;

[0026] In a preferred embodiment of the present invention, the composition is a topical preparation.

[0027] The purpose of this invention is to provide a method for preparing a pain-relieving pharmaceutical composition. The composition, by weight, contains 10-30 parts of Angelica sinensis, 10-30 parts of Chaenomeles speciosa, 10-30 parts of Paeonia lactiflora, 10-30 parts of Boswellia carterii, 10-30 parts of Eupolyphaga sinensis, 5-20 parts of Sappanwood, 5-20 parts of Carthamus tinctorius, 0.1-5 parts of Dracaena cochinchinensis, 5-20 parts of Syzygium aromaticum, 20-40 parts of Hibiscus mutabilis leaf, 20-40 parts of Citrus aurantium, 10-25 parts of Myrrh, and 20-40 parts of calcined natural copper. The preparation includes the following steps: uniformly mixing the required amounts of components and grinding them into a fine powder.

[0028] The preferred embodiment of the present invention, by weight, comprises 15-25 parts of Angelica sinensis, 15-25 parts of Chaenomeles speciosa, 15-25 parts of Paeonia lactiflora, 15-25 parts of Boswellia carterii, 15-25 parts of Eupolyphaga sinensis, 8-15 parts of Sappanwood, 8-15 parts of Carthamus tinctorius, 0.5-3 parts of Dracaena cochinchinensis, 8-15 parts of Syzygium aromaticum, 25-35 parts of Hibiscus mutabilis leaf, 25-35 parts of Citrus aurantium, 15-20 parts of Commiphora myrrha, and 25-35 parts of calcined natural copper.

[0029] The preferred embodiment of the present invention, by weight, comprises 20 parts of Angelica sinensis, 20 parts of papaya, 20 parts of Paeonia lactiflora, 20 parts of frankincense, 20 parts of Eupolyphaga sinensis, 10 parts of Sappanwood, 10 parts of Carthamus tinctorius, 1 part of Dragon's Blood, 10 parts of clove, 30 parts of Hibiscus mutabilis leaf, 30 parts of Osmanthus fragrans, 18 parts of myrrh, and 30 parts of calcined natural copper.

[0030] The preferred embodiment of the present invention, by weight, comprises 15 parts of Angelica sinensis, 15 parts of papaya, 15 parts of Paeonia lactiflora, 15 parts of frankincense, 15 parts of Eupolyphaga sinensis, 5 parts of Sappanwood, 5 parts of Carthamus tinctorius, 1 part of Dragon's Blood, 5 parts of Clove, 20 parts of Hibiscus mutabilis leaf, 10 parts of Golden Fruit Olive, 15 parts of Myrrh, and 20 parts of Calcined Natural Copper.

[0031] The preferred embodiment of the present invention, by weight, comprises 30 parts of Angelica sinensis, 30 parts of papaya, 30 parts of Paeonia lactiflora, 30 parts of frankincense, 20 parts of Eupolyphaga sinensis, 10 parts of Sappanwood, 10 parts of safflower, 1 part of dragon's blood, 10 parts of clove, 30 parts of Hibiscus mutabilis leaf, 30 parts of golden elm, 18 parts of myrrh, and 30 parts of calcined natural copper.

[0032] In a preferred embodiment of the present invention, the fine powder of the pharmaceutical composition is 150-200 mesh.

[0033] In a preferred embodiment of the present invention, the prepared pharmaceutical composition powder is mixed with a solvent to form an ointment or paste before use. The ointment or paste is then applied to the patient's painful or affected area, and massaged for 3-5 minutes using any one or a combination of gentle rubbing, pushing, or palm kneading techniques. The medicine is then covered with a transparent film for 15-20 minutes, once a day, for 20-30 minutes each time. The solvent is selected from any one of water, ginger juice, vinegar, or white wine.

[0034] In a preferred embodiment of the present invention, the mass-to-volume ratio of the pharmaceutical composition fine powder to the solvent is 1:10-20;

[0035] In a preferred embodiment of the present invention, the composition is a topical preparation.

[0036] Another object of the present invention is to provide the use of the pharmaceutical compositions of the present invention in the preparation of medicaments for the prevention or relief of pain or pain-related conditions or their complications.

[0037] In the preferred embodiment of the present invention, the pain is selected from pain caused by arthralgia, soft tissue injury, chronic strain of the neck, shoulder, waist and leg, acute trauma or chronic strain, pathological damage or sequelae of injury to the skin, subcutaneous superficial and deep fascia, muscles, tendons, ligaments, joint capsules and intervertebral discs caused by invasion of wind, cold and dampness, fracture, dislocation, joint pain, neck, shoulder, waist and leg pain, osteoarthritis, myofascitis or any of its complications.

[0038] In a preferred embodiment of the present invention, the arthralgia is selected from any one of shoulder arthralgia, lumbar arthralgia, and knee arthralgia.

[0039] In a preferred embodiment of the present invention, the shoulder pain is selected from any one of frozen shoulder, rotator cuff injury, or shoulder pain caused by their complications.

[0040] In a preferred embodiment of the present invention, the lumbar pain syndrome is selected from any one of lumbar disc herniation, lumbar spinal stenosis, lumbar muscle strain, or lumbar pain syndrome caused by their complications.

[0041] In a preferred embodiment of the present invention, the pain or discomfort is selected from any one of the following: pain in the affected area, limited mobility, soreness and weakness in the lower back and knees, morning stiffness, limb swelling and pain, difficulty in flexion and extension, and fatigue.

[0042] The preferred technical solution of the present invention selects an appropriate dosage and course of treatment based on factors such as the patient's condition, medication, age, gender, and type of pain.

[0043] In a preferred embodiment of the present invention, the dosage of the applied drug composition is determined according to the size of the painful area of ​​the lesion.

[0044] In a preferred embodiment of the present invention, the dosage of the pharmaceutical composition is 50-80g.

[0045] In a preferred embodiment of the present invention, the prepared pharmaceutical composition powder is mixed with a solvent to form an ointment or paste before use. The ointment or paste is then applied to the patient's painful or affected area, and massaged for 3-5 minutes using any one or a combination of gentle rubbing, pushing, or palm kneading techniques. The medicine is then covered with a transparent film for 15-20 minutes, once a day, for 20-30 minutes each time. The solvent is selected from any one of water, ginger juice, vinegar, or white wine.

[0046] In a preferred embodiment of the present invention, the mass-to-volume ratio of the pharmaceutical composition fine powder to the solvent is 1:10-20;

[0047] In a preferred embodiment of the present invention, the composition is a topical preparation.

[0048] Unless otherwise stated, when this invention relates to percentages between liquids, the percentage is volume / volume percentage; when this invention relates to percentages between liquids and solids, the percentage is volume / weight percentage; when this invention relates to percentages between solids and liquids, the percentage is weight / volume percentage; the remainder is weight / weight percentage.

[0049] Compared with the prior art, the present invention has the following beneficial effects:

[0050] 1. The pharmaceutical composition of this invention is scientifically formulated based on the principle of syndrome differentiation and treatment. It utilizes the blood-tonifying and blood-activating properties of Angelica sinensis, synergistically employing components such as Paeonia lactiflora, Chaenomeles speciosa, Carthamus tinctorius, and Sappanwood, which have the effects of activating blood circulation, removing blood stasis, relaxing muscles and tendons, relieving pain, promoting blood circulation, relaxing muscles and tendons, dispersing blood stasis, promoting qi and blood flow, relaxing muscles and tendons, and dispersing blood stasis. It also synergistically utilizes components such as Frankincense, Myrrh, Eupolyphaga sinensis, Dragon's Blood, Hibiscus mutabilis leaf, Golden Fruit, and Calcined Natural Copper, which have the effects of activating blood circulation, relieving pain, breaking up blood stasis, softening and dispersing nodules, cooling blood and reducing swelling, and have the effects of activating blood circulation, removing blood stasis, promoting bone healing, and dispelling blood stasis. The ingredients have the effects of dispelling wind and dampness, dispelling cold and relieving pain. They effectively prevent and treat muscle tension and stiffness, significantly improve symptoms such as soft tissue injury, muscle tension and stiffness, chronic strain in the neck, shoulders, waist and legs, and residual pain or discomfort after injury. They also significantly reduce the pain recurrence rate and significantly prolong the pain recurrence interval. They have the advantages of rapid onset of action, high treatment efficacy (≥96%) and high significant efficacy (≥65%), low recurrence rate, prolonged recurrence interval, easy preparation, convenient use, safety and effectiveness, and good patient compliance.

[0051] 2. The medicinal materials used in the preparation of the pharmaceutical composition of the present invention have the advantages of being widely available, easy to prepare, cost-effective, and suitable for industrial production. Detailed Implementation

[0052] The following detailed explanation and description of the present invention, in conjunction with specific embodiments, does not limit the scope of protection of the present invention.

[0053] Example 1Preparation of the pharmaceutical composition of the present invention

[0054] Composition of the composition: 20 parts Angelica sinensis, 20 parts Chaenomeles speciosa, 20 parts Paeonia lactiflora, 20 parts Boswellia carterii, 20 parts Eupolyphaga sinensis, 10 parts Sappanwood, 10 parts Carthamus tinctorius, 1 part Draconis blood, 10 parts Clove, 30 parts Hibiscus mutabilis leaf, 30 parts Gynostemma pentaphyllum, 18 parts Myrrh, 30 parts Calcined natural copper.

[0055] Preparation of the composition: Weigh the required amount of components, mix them evenly, and grind them into a fine powder of 150-200 mesh.

[0056] Example 2 Preparation of the pharmaceutical composition of the present invention

[0057] Composition of the composition: 15 parts Angelica sinensis, 15 parts Chaenomeles speciosa, 15 parts Paeonia lactiflora, 15 parts Boswellia carterii, 15 parts Eupolyphaga sinensis, 5 parts Sappanwood, 5 parts Carthamus tinctorius, 1 part Dracaena cochinchinensis, 5 parts Clove, 20 parts Hibiscus mutabilis leaf, 10 parts Gynostemma pentaphyllum, 15 parts Myrrh, 20 parts Calcined natural copper.

[0058] Preparation of the composition: Weigh the required amount of components, mix them evenly, and grind them into a fine powder of 150-200 mesh.

[0059] Example 3 Preparation of the pharmaceutical composition of the present invention

[0060] Composition of the composition: 30 parts Angelica sinensis, 30 parts Chaenomeles speciosa, 30 parts Paeonia lactiflora, 30 parts Boswellia carterii, 20 parts Eupolyphaga sinensis, 10 parts Sappanwood, 10 parts Carthamus tinctorius, 1 part Dracaena cochinchinensis, 10 parts Clove, 30 parts Hibiscus mutabilis leaf, 30 parts Osmanthus fragrans, 18 parts Myrrh, and 30 parts Calcined natural copper.

[0061] Preparation of the composition: Weigh the required amount of components, mix them evenly, and grind them into a fine powder of 150-200 mesh.

[0062] Experimental Example 1 Study on the effect of the pharmaceutical composition of the present invention in relieving pain

[0063] 255 patients who visited the orthopedic outpatient department of Dongfang Hospital from January 2020 to December 2022 were randomly selected and divided into a treatment group and a control group. There were no statistically significant differences in age, disease duration, and other general characteristics between the two groups (P>0.05).

[0064] The treatment group consisted of 220 patients, including 89 males and 131 females; the youngest was 35 years old and the oldest was 78 years old, with a mean age of 56.73 ± 5.81 years; the longest history of illness was 8 years and the shortest was 3 months, with a mean duration of illness of 8.51 ± 7.93 months. The treatment group included 46 cases of shoulder pain (frozen shoulder, rotator cuff injury), 32 cases of cervical spondylosis, 85 cases of lumbar pain (lumbar disc herniation, lumbar spinal stenosis, lumbar muscle strain), 44 cases of knee pain, and 13 cases of other conditions (limb joint pain, myofascitis, strain). The control group consisted of 8 cases of shoulder pain, 6 cases of cervical spondylosis, 12 cases of lumbar pain, 7 cases of knee pain, and 2 other conditions.

[0065] Patients in the treatment group were given the drug composition of Example 1, and the drug powder was prepared using 53... 。 Mix the white wine evenly to make a paste. Apply the paste to the patient's painful area and massage with gentle rubbing, pushing, and palm kneading techniques. The massage should be even and gentle, gradually increasing in pressure from light to heavy. The pressure and temperature should be adjusted to the patient's tolerance. Massage for 3-5 minutes, then cover the paste with a transparent film for 15-20 minutes. Repeat once a day for 20-30 minutes each time. One course of treatment is 7 days, and two courses of treatment should be given consecutively.

[0066] The control group consisted of 35 patients, including 16 males and 19 females, with a mean age of 57.57 ± 5.43 years and a mean disease duration of 8.54 ± 8.12 months. The control group received topical diclofenac diethylamine emulsion ointment as a positive control. The ointment was applied to the affected area and gently massaged in to allow penetration, three times a day. One course of treatment lasted seven days, and two consecutive courses were administered.

[0067] The pain levels of patients in the treatment group and the control group were compared and evaluated before treatment, after one course of treatment (7 days), and after two courses of treatment (14 days). The overall effective rate was also compared. Adverse reactions such as general vital signs, nausea and vomiting, headache and dizziness, and skin allergies were recorded.

[0068] 1. All patients were assessed for pain status before and after treatment using the visual analogue scale (VAS). The pain was scored from 0 to 10 based on the degree of pain: no pain was 0 points; mild pain was ≤3 points, where the patient had pain but could live a normal life; moderate pain was >3 to 6 points, where the pain was persistent, unbearable, and required analgesics; and severe pain was >6 points, where the pain was intense, required analgesics, and seriously affected the patient's life and work.

[0069] Assessment method: A straight line is drawn on a piece of white paper, and scales are marked to represent the score (0-10 points). The higher the score, the more severe the pain. Patients mark the corresponding scales to indicate the intensity of their pain before and after treatment, and researchers accurately record the data.

[0070] 2. The efficacy evaluation criteria were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". Marked effect: pain at the affected area basically disappears, and function is significantly improved; Effective: pain at the affected area is significantly relieved, and function is somewhat improved; Ineffective: pain symptoms do not improve or worsen, and functional activities are significantly limited.

[0071] Overall effective rate = (number of cases with significant effect + number of cases with effect) / total number of cases × 100%.

[0072] The study data were statistically analyzed and processed using SPSS 20.0 software. Count data were expressed as number of cases or percentages, and continuous data were expressed as mean ± standard deviation (x±s). The chi-square test was used for comparisons between groups. Independent samples t-test was used for comparisons between groups. P < 0.05 was considered statistically significant.

[0073] 3. Research Results

[0074] (1) VAS score results

[0075] Before treatment, there was no statistically significant difference in VAS scores between the treatment group and the control group (P > 0.05). After 7 and 14 days of treatment, the VAS scores of both groups were lower than before treatment, and the VAS score of the treatment group was significantly lower than that of the control group (P < 0.05), as shown in Table 1. Compared with diclofenac diethylamine emulsion, the pharmaceutical composition of the present invention has a better effect on relieving pain at the affected area. More than half of the patients experienced significant relief or disappearance of pain symptoms after 3-5 days of treatment with the drug of the present invention, demonstrating the advantage of rapid onset of action.

[0076] Table 1

[0077]

[0078] illustrate: This indicates a comparison with pre-treatment values ​​(P < 0.05). ＃ This indicates a comparison with the results after 7 days of treatment (P < 0.05).

[0079] (2) Results of efficacy evaluation (see Table 2)

[0080] In the treatment group, 147 cases showed significant improvement, 67 cases showed improvement, and 6 cases showed no improvement, with a total effective rate (97.27%) and a significant improvement rate (66.82%). In the control group, 13 cases showed significant improvement, 18 cases showed improvement, and 4 cases showed no improvement, with a total effective rate (88.57%) and a significant improvement rate (37.14%). Compared with the control group, the total effective rate and significant improvement rate of the treatment group were significantly different (P < 0.05). The pharmaceutical composition of the present invention has a significantly better total effective rate and significant improvement rate than the control drug diclofenac diethylamine emulsion.

[0081] Table 2

[0082]

[0083] No adverse reactions such as skin allergies were reported by patients in either the treatment group or the control group during the treatment period, indicating that the drug of this invention is safe and effective.

[0084] The pharmaceutical compositions of Examples 1-3 have substantially the same activity, efficacy, and safety. Cases 1-5 are now used to illustrate the safety and efficacy of the pharmaceutical compositions of Examples 1-3.

[0085] Case 1: Patient Zhang, male, 46 years old, visited the hospital outpatient clinic in March 2020. His chief complaint was lower back pain and discomfort that had lasted for six months and worsened in the past month. He reported that topical medications had not relieved the pain in the past two weeks, and the symptoms had not improved and had even worsened. After a physical examination and a lumbar CT scan, the outpatient physician diagnosed him with "lumbar disc herniation," and the patient's VAS score was 7. After two courses of treatment with the topical medication composition described in Example 3, the patient reported a significant reduction in lower back pain symptoms after three days of application, and his VAS score was 3. After two weeks of treatment, the patient's pain and symptoms disappeared, and he recovered, with a VAS score of 0.

[0086] Case 2: Patient Dong, female, 57 years old, visited the hospital outpatient clinic in November 2020. The patient reported a 3-year history of bilateral knee pain, including pain and coldness in both knee joints, lower limb soreness, and difficulty walking in severe cases. The pain had worsened in the past two months. She had previously been diagnosed with "bilateral knee osteoarthritis," and her VAS score was 9. The patient was treated with the topical drug composition of Example 1 for two courses of treatment. After one course, the patient's knee pain symptoms were relieved, and her VAS score decreased to 4. After two consecutive courses of treatment, there was no significant pain or coldness in the joints, joint flexion and extension were basically normal, walking was unimpeded, and her VAS score decreased to 1.

[0087] Case 3: Patient Li, male, 52 years old, visited the hospital outpatient clinic in August 2020. His chief complaint was neck discomfort for nearly a year. Five days prior, he developed pain in his neck and left shoulder, with limited neck movement. His symptoms did not improve after massage and cupping therapy at a community hospital. Physical examination and X-ray examination revealed straightening of the cervical spine's physiological curvature and osteophyte formation at the anterior and posterior margins of the 4th and 5th cervical vertebrae. He was diagnosed with cervical spondylosis, with a VAS score of 7. The patient received two courses of external application of the drug composition described in Example 2. Two days after treatment, the patient experienced significant reduction in pain and neck movement limitation, and his VAS score decreased to 2. After two courses of treatment, the patient's neck and shoulder pain and limited neck movement completely disappeared, and his VAS score dropped to 0.

[0088] Case 4: Mr. Jiao, male, 28 years old, presented in April 2021. He reported spraining his left knee three days prior while playing basketball, resulting in swelling and pain. Topical medication sprays and cold compresses were ineffective after the injury. The swelling and pain worsened on the second day, with pain in his left lower limb affecting walking and limited flexion and extension of his left knee. His VAS score was 8. After physical examination and review of X-rays, the outpatient physician diagnosed soft tissue injury, considering muscle damage in the left lower limb and collateral ligament injury of the left knee joint. After one course of treatment with the topical medication composition described in Example 3, the patient's pain significantly decreased, swelling mildly subsided, and left knee flexion and extension function significantly improved, allowing him to walk almost completely. His VAS score decreased to 3. After two consecutive courses of treatment, the patient's symptoms essentially disappeared, knee joint function returned to normal, and his VAS score decreased to 1.

[0089] Case 5: Ms. Yang, female, 68 years old, consulted in June 2021. Chief complaint: Right shoulder pain caused by shoulder strain 3 years prior, which was relieved by treatment. For the past two years, she has frequently experienced dull pain in her right shoulder, sometimes radiating to the right side of her neck. She reported using diclofenac sodium and topical plasters for the past 3 months, but the pain symptoms were not relieved; her VAS score was 7. After physical examination and review of X-rays, the outpatient physician diagnosed right shoulder joint degeneration, suggestive of rotator cuff injury. After one course of treatment with the drug composition described in Example 2, the dull pain in her right shoulder essentially disappeared, and her VAS score decreased to 2. After two consecutive courses of treatment, the pain in her neck and shoulder completely disappeared, and her VAS score decreased to 0.

[0090] The above description of specific embodiments of the present invention does not limit the present invention. Those skilled in the art can make various changes or modifications based on the present invention, and as long as they do not depart from the spirit of the present invention, they should all fall within the scope of protection of the claims of the present invention.

Claims

1. A pain-relieving pharmaceutical composition, comprising, by weight, 10-30 parts of Angelica sinensis, 10-30 parts of Chaenomeles speciosa, 10-30 parts of Paeonia lactiflora, 10-30 parts of Boswellia carterii, 10-30 parts of Eupolyphaga sinensis, 5-20 parts of Sappanwood, 5-20 parts of Carthamus tinctorius, 0.1-5 parts of Daemonorops draco, 5-20 parts of Syzygium aromaticum, 20-40 parts of Hibiscus mutabilis leaf, 20-40 parts of Leonurus japonicus, 10-25 parts of Commiphora myrrha, and 20-40 parts of calcined natural copper. The preparation method of the pharmaceutical composition is as follows: weigh the required amount of components, mix them evenly, and grind them into a fine powder.

2. The pharmaceutical composition according to claim 1, by weight, comprises 15-25 parts of Angelica sinensis, 15-25 parts of Chaenomeles speciosa, 15-25 parts of Paeonia lactiflora, 15-25 parts of Boswellia carterii, 15-25 parts of Eupolyphaga sinensis, 8-15 parts of Sappanwood, 8-15 parts of Carthamus tinctorius, 0.5-3 parts of Dracaena cochinchinensis, 8-15 parts of Syzygium aromaticum, 25-35 parts of Hibiscus mutabilis leaf, 25-35 parts of Citrus aurantium, 15-20 parts of Commiphora myrrha, and 25-35 parts of calcined natural copper.

3. The pharmaceutical composition according to claim 2, by weight, comprises 20 parts of Angelica sinensis, 20 parts of Chaenomeles speciosa, 20 parts of Paeonia lactiflora, 20 parts of Boswellia carterii, 20 parts of Eupolyphaga sinensis, 10 parts of Sappanwood, 10 parts of Carthamus tinctorius, 1 part of Dracaena cochinchinensis, 10 parts of Syzygium aromaticum, 30 parts of Hibiscus mutabilis leaf, 30 parts of Citrus aurantium, 18 parts of Commiphora myrrha and 30 parts of calcined natural copper.

4. The pharmaceutical composition according to claim 2, in parts by weight, comprises 15 parts of Angelica sinensis, 15 parts of Chaenomeles speciosa, 15 parts of Paeonia lactiflora, 15 parts of Boswellia carterii, 15 parts of Eupolyphaga sinensis, 5 parts of Sappanwood, 5 parts of Carthamus tinctorius, 1 part of Dracaena cochinchinensis, 5 parts of Syzygium aromaticum, 20 parts of Hibiscus mutabilis leaf, 10 parts of Citrus aurantium, 15 parts of Commiphora myrrha and 20 parts of calcined natural copper.

5. The pharmaceutical composition according to claim 2, in parts by weight, comprises 30 parts of Angelica sinensis, 30 parts of Chaenomeles speciosa, 30 parts of Paeonia lactiflora, 30 parts of Boswellia carterii, 20 parts of Eupolyphaga sinensis, 10 parts of Sappanwood, 10 parts of Carthamus tinctorius, 1 part of Dracaena cochinchinensis, 10 parts of Syzygium aromaticum, 30 parts of Hibiscus mutabilis leaf, 30 parts of Citrus aurantium, 18 parts of Commiphora myrrha and 30 parts of calcined natural copper.

6. The pharmaceutical composition according to any one of claims 1-5, wherein the fine powder of the pharmaceutical composition is 150-200 mesh.

7. The pharmaceutical composition according to any one of claims 1-5, wherein the composition is a topical preparation.

8. A method for preparing a pain-relieving pharmaceutical composition according to any one of claims 1-7, comprising the following steps: uniformly mixing the required amounts of components and grinding them into a fine powder, thereby obtaining the product.

9. The use of the pharmaceutical composition according to any one of claims 1-7 in the preparation of a medicament for preventing or relieving pain, wherein the pain is selected from arthralgia, wherein the arthralgia is selected from any one of shoulder arthralgia, lumbar arthralgia, and knee arthralgia, wherein the shoulder arthralgia is selected from any one of frozen shoulder and rotator cuff injury, and wherein the lumbar arthralgia is selected from any one of lumbar disc herniation, lumbar spinal stenosis, and lumbar muscle strain.

10. The use of the pharmaceutical composition according to any one of claims 1-7 in the preparation of a medicament for preventing or relieving pain, wherein the pain is selected from pain caused by any one of cervical spondylosis or myofascitis.

11. The use of the pharmaceutical composition according to any one of claims 1-7 in the preparation of a medicament for preventing or relieving pain, wherein the pain is joint pain in the limbs.

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