External traditional Chinese medicine preparation for relieving arthralgia

Abstract

The invention provides an external traditional Chinese medicine preparation for relieving arthralgia, and relates to the technical field of traditional Chinese medicine preparation. The external traditional Chinese medicine preparation for relieving arthralgia, which is prepared from photinia serrulata leaves, campsis grandiflora, herba siegesbeckiae, roses, artemisia anomala, girald daphne bark, geranium wilfordii, tortoise-shell glue, fructus broussonetiae, hibiscus mutabilis, erycibe obtusifolia benth, arisaema cum bile, oroxylum indicum and cortex fraxini, is reasonably combined according to the principle of dialectical treatment of traditional Chinese medicine and is used for relieving arthralgia from pathogenesis aiming at pain caused by osteoarthritis. The traditional Chinese medicine preparation has a good treatment effect on a rat model with gonitis, has a good detumescence effect on arthrocele, can reduce the levels of inflammatory factors TNF-alpha, IL-18 and IL-6, has an excellent anti-inflammatory effect, can improve the pain domain value, reduce the 5-HT level and improve the beta-EP level, and has a good analgesic and analgesic effect. The traditional Chinese medicine preparation disclosed by the invention is expected to provide a novel treatment method and medicine for treating pain caused by osteoarthritis.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical manufacturing, and in particular to an external-use traditional Chinese medicine preparation for relieving joint pain. Background Art

[0002] Osteoarthritis (OA) is a degenerative joint disease caused by trauma, aging, metabolic abnormalities, and other factors. Its pathological features include cartilage destruction, synovial inflammation, bone hyperplasia, and subchondral ossification. The incidence of OA in people over 60 years old in my country has exceeded 60%, and joint pain, especially long-term chronic pain, is the most common cause of distress for OA patients. Long-term pain not only exacerbates patients' physical suffering but can also cause psychological burdens such as insomnia, anxiety, and depression. The clinical treatment principle for OA patients is to alleviate pain, improve their quality of life, and thereby alleviate articular cartilage breakdown. Oral nonsteroidal anti-inflammatory drugs and corticosteroid injections are the international standard nonsurgical treatment options for knee OA. Although they have achieved positive results, they are associated with serious side effects and are not suitable for long-term use. Patients will also continue to suffer from long-term pain, and long-term drug treatment has low clinical acceptance. Western medicine patches are also a commonly used treatment for this disease, such as flurbiprofen plaster, which can improve pain symptoms. However, the pain-relieving effect of Western medicine patches is limited, the effect time period is short, and the overall efficacy is general, which has limitations.

[0003] Traditional Chinese Medicine is extensive and profound, and has demonstrated good therapeutic effects in many diseases. External treatment of TCM has a long history and profound theoretical contributions, and has gradually become the mainstream means of clinical treatment of OA. External treatment of TCM is a treatment method based on the basic theories of TCM and the efficacy of Chinese medicine, with the main indications and meridians as the principles, and reasonable drug compatibility. It uses fumigation, external application, tamponade, ironing, ion introduction and other external means that directly act on the affected area to exert the effect of drugs. The present invention aims to provide a topical Chinese medicine preparation that can achieve rapid and continuous relief of pain in OA patients and improve the clinical symptoms of OA patients. Summary of the Invention

[0004] (1) Technical problems solved

[0005] In view of the deficiencies of the prior art, the present invention provides an external-use Chinese medicine preparation for relieving joint pain.

[0006] (2) Technical solution

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0008] First, the present invention provides an external Chinese medicine preparation for relieving joint pain. The Chinese medicine preparation is composed of the following raw materials in parts by weight: 20-40 parts of Photinia purpurogena leaves, 20-40 parts of Campsis creeper, 20-40 parts of Siegesbeckia herba, 20-40 parts of Rose, 20-40 parts of Achyranthes bidentata, 10-30 parts of Zushima hemp, 10-30 parts of Geranium herb, 10-30 parts of Tortoise shell glue, 10-30 parts of Cuscuta australis seeds, 10-30 parts of Hibiscus rosea, 10-30 parts of Dinggong vine, 10-30 parts of Arisaema cinerea, 10-30 parts of Oroxylum indicum, and 10-30 parts of Qinpi.

[0009] Furthermore, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 25-35 parts of Photinia purpurogena leaves, 25-35 parts of Campsis creeper, 25-35 parts of Siegesbeckia herba, 25-35 parts of Rose, 20-30 parts of Achyranthes bidentata, 10-20 parts of Zushima hemp, 15-25 parts of Geranium herb, 15-25 parts of Tortoise shell glue, 10-20 parts of Cuscuta australis seeds, 10-20 parts of Hibiscus rosea, 10-20 parts of Dinggong vine, 15-25 parts of Arisaema cinerea, 10-20 parts of Oroxylum indicum, and 10-20 parts of Qinpi.

[0010] Furthermore, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 32 parts of Photinia purpurogena leaves, 30 parts of Campsis creeper, 28 parts of Siegesbeckia herba, 26 parts of rose, 24 parts of Achyranthes bidentata, 12 parts of Zushima hemp, 18 parts of Geranium herb, 20 parts of tortoise shell glue, 16 parts of Cuscuta australis seeds, 16 parts of Hibiscus rosea, 14 parts of Dinggongteng, 20 parts of Arisaema cinerea, 12 parts of Oroxylum indicum, and 14 parts of Qinpi.

[0011] The traditional Chinese medicine preparation provided by the present invention is used to prepare an external-use medicine for treating arthritis pain. Specifically, the raw materials are weighed according to the above-mentioned parts by weight, and medically acceptable excipients are added according to a commonly used medical preparation method to prepare an external-use dosage form. The dosage form includes black plasters, ointments, tinctures, lotions, powders, hot compress packs, rubber patches, gel ointments, creams, film coatings, and ion-penetrating drugs.

[0012] Photinia leaves are pungent, bitter, and neutral; they are slightly toxic. They enter the liver and kidney meridians, dispelling rheumatism, unblocking meridians, and tonifying kidney qi. They are used for rheumatic pain, back pain, weakness in the feet and knees, and migraines. Modern research indicates that photinia leaves have analgesic, sedative, and anti-inflammatory properties.

[0013] Campsis globulus (Campsis globulus) is sweet, sour, and cold. It enters the Liver and Pericardium meridians. It promotes blood circulation, removes blood stasis, cools the blood, and dispels wind. It is used to treat amenorrhea, abdominal masses, postpartum breast swelling, urticaria, itchy skin, and acne. Pharmacological studies have shown that Campsis globulus has certain antibacterial, anti-inflammatory, and immunomodulatory effects.

[0014] Siegesbeckia herba is pungent, bitter, and cold. It enters the liver and kidney meridians. It dispels rheumatism, benefits joints, and detoxifies. It is used to treat rheumatic pain, weakness in the tendons and bones, soreness of the waist and knees, paralysis of the limbs, hemiplegia, and urticaria. Modern pharmacological research has shown that Siegesbeckia herba has anti-inflammatory, analgesic, blood pressure-lowering, and antibacterial properties.

[0015] Rose flower is sweet, slightly bitter, and warm. It enters the liver and spleen meridians. It promotes qi circulation, relieves depression, and regulates blood circulation to relieve pain. It is used to treat liver and stomach pain, loss of appetite, nausea, irregular menstruation, and pain from falls. Rose flower has a calming effect on the central nervous system and also has antioxidant and antibacterial properties.

[0016] Liuji Nu (Ligusticum chuanxiong) is bitter and warm. It enters the Heart, Liver, and Spleen meridians. It promotes blood circulation and promotes menstruation, astringing sores and reducing swelling. It is used for amenorrhea, abdominal masses, chest and abdominal distension and pain, postpartum blood stasis, traumatic injuries, bleeding wounds, and carbuncle swelling. Liuji Nu promotes blood circulation and accelerates wound healing.

[0017] Zushima (Zushi Ma) is pungent, bitter, and warm; it is slightly toxic. It enters the Heart and Liver meridians. It dispels wind and dampness, promotes blood circulation, and relieves pain. It is used for rheumatic pain, numbness of the limbs, headaches, stomachaches, and traumatic injuries. It has anti-inflammatory, analgesic, and sedative effects.

[0018] Geranium herb is pungent, bitter, and neutral. It enters the liver, kidney, and spleen meridians. It dispels rheumatism, dredges the meridians, and relieves diarrhea. It is used for rheumatic pain, numbness and cramps, muscle and bone pain, and diarrhea and dysentery. Modern research shows that geranium herb has antibacterial, antiviral, anti-inflammatory, and antidiarrheal properties.

[0019] Turtle Shell Glue is salty, sweet, and neutral. It enters the Liver, Kidney, and Heart meridians. It nourishes Yin, nourishes blood, and stops bleeding. It is used for hot flashes due to Yin deficiency, night sweats due to bone steaming, soreness of the waist and knees, sallow complexion due to blood deficiency, and metrorrhagia and leukorrhea. It can enhance the body's immune function, promote hematopoiesis, and have a certain sedative effect.

[0020] Cuscuta chinensis seeds are sweet and cold. They enter the liver and kidney meridians. They tonify the kidneys and clear the liver, improve eyesight, and promote urination. They are used for soreness of the waist and knees, asthenia due to bone steaming, dizziness, blurred vision, pannus, and edema. Cuscuta chinensis seeds have immune-enhancing, antioxidant, and diuretic properties.

[0021] Hibiscus flower is pungent and neutral. It enters the Lung, Heart, and Liver meridians. It clears heat and detoxifies, cools blood and stops bleeding, and reduces swelling and discharges pus. It is used to treat lung-heat-induced cough, hematemesis, red and painful eyes, metrorrhagia, leucorrhea, diarrhea, abdominal pain, carbuncles, boils, and snake bites. Hibiscus flower has antibacterial, anti-inflammatory, and antioxidant properties.

[0022] Dinggongteng is pungent, warm, and slightly toxic. It enters the Liver, Spleen, and Stomach meridians. It dispels wind and dampness, reduces swelling and relieves pain. It is used for rheumatic pain, hemiplegia, and swelling and pain from falls. Dinggongteng has anti-inflammatory, analgesic, and blood circulation-improving properties.

[0023] Arisaema ciliata is bitter, slightly pungent, and cooling. It enters the Liver and Gallbladder meridians. It clears heat and resolves phlegm, calms wind and soothes convulsions. It is used for coughs caused by phlegm-heat, thick yellow sputum, phlegm retention caused by stroke, and epilepsy. Arisaema ciliata has sedative, anticonvulsant, and expectorant effects.

[0024] Oroxylum butterfly (Silver Butterfly) is bitter, sweet, and cooling. It enters the Lung, Liver, and Stomach meridians. It clears the lungs and relieves sore throat, soothes the liver and harmonizes the stomach. It is used for lung-heat coughs, sore throats, hoarseness, and liver and stomach pain. Oroxylum butterfly has anti-inflammatory, antibacterial, and antioxidant properties.

[0025] Fraxinus root bark is bitter, astringent, and cold. It enters the liver, gallbladder, and large intestine meridians. It clears heat and dries dampness, astringes and stops diarrhea and leukorrhea, and improves eyesight. It is used for diarrhea caused by damp-heat, leukorrhea, red and swollen eyes, and pannus. Fraxinus root bark has antibacterial, anti-inflammatory, antioxidant, and antitussive and expectorant properties.

[0026] (3) Beneficial effects

[0027] The present invention is based on the principle of TCM syndrome differentiation and treatment, and for the pain caused by osteoarthritis, starting from the pathological pathogenesis, a Chinese medicine preparation for external use made from Photinia purpurogena, Campsis Flos, Herba Siegesbeckiae, Flos Rosae Rugosae, Herba Achyranthis Bidentatae, Herba Geraniae, Herba Tortoiseellae, Herba Cuscutae, Herba Hibisci, Herba Dioscoreae, Herba Glehniae, Herba Corydalis, Herba Corydalis, Herba Corydalis, Herba Corydalis, Herba Corydalis, Herba Corydalis, Herba Corydalis, Herba Corydalis, Herba Corydalis, Herba Cibotii, Herba Hibisci, Herba Dioscoreae, Herba Arisaematis, Herba Oroxylum, and Herba Fraxini is rationally combined to alleviate joint pain. Animal experiment results show that the Chinese medicine preparation of the present invention has a good therapeutic effect on a rat model of knee arthritis, has a good detumescence effect on joint swelling, can achieve a reduction in the levels of inflammatory factors TNF-α, IL-18, and IL-6, has a relatively excellent anti-inflammatory effect, and can achieve an increase in pain threshold, reduce 5-HT levels, increase β-EP levels, and has a good analgesic and analgesic effect. The Chinese medicine preparation of the present invention is expected to provide a new treatment method and medicine for the pain caused by treating osteoarthritis.

[0028] The traditional Chinese medicine preparation of the present invention uses photinia leaves and trumpet creeper as main medicines. The photinia leaves dispel rheumatism, dredge meridians, nourish the liver and kidneys, and strengthen tendons and bones; the trumpet creeper dissolves blood stasis, dredges meridians, and improves local qi and blood circulation. The combination of the photinia leaves and the trumpet creeper has the effects of one warming and one cooling, one nourishing and one unblocking, one moistening and one breaking, strengthening the body and eliminating evil at the same time, and laying a foundation for comprehensive treatment. Herba Siegesbeckiae dispels rheumatism and benefits joints, and can help Photinia and Campsis flower enhance their functions of dispelling rheumatism and unblocking meridians, and can clear away the heat evil caused by long-term arthritis and pain, and relieve symptoms of redness, swelling, heat and pain in joints; Rose flower promotes qi and relieves depression, harmonizes blood and relieves pain, and can make qi and blood flow smoothly, assist Campsis flower in removing blood stasis and dredging menstruation, while restraining the coldness of the cold medicines in the prescription to prevent cold from clotting the blood vessels and affecting the circulation of qi and blood; Achyranthes bidentata dispels blood stasis and relieves pain, heals wounds and stops bleeding, and works together with Campsis flower to strengthen its blood stasis-removing power; Herba Achyranthis Bidentatae dispels wind and dampness, relieves pain and disperses blood stasis, and helps Photinia dispel rheumatism and relieve pain; Herba Siegesbeckiae, Rose flower, Achyranthes bidentata and Campsis flower are all ministers, assisting the monarch medicines at different levels to achieve the effects of dispelling rheumatism, promoting qi and blood circulation, removing blood stasis and relieving pain. The herb can dispel wind and dampness, invigorate blood circulation and dredge meridians, and can enhance the anti-rheumatic effect of the whole prescription, and its medicinal properties are mild and can harmonize the other medicines; tortoise shell glue nourishes yin and suppresses yang, benefits the kidney and strengthens bones, and is supplemented by Photinia pruriens to nourish the liver and kidneys; Cuscuta chinensis nourishes the kidney and clears the liver, and assists tortoise shell glue in nourishing yin and tonifying the kidney, and its liver-clearing nature can balance the warming properties of some medicines in the prescription, making the whole prescription suitable for both cold and warm temperatures; Hibiscus flower clears heat and detoxifies, cools blood and stops bleeding, reduces swelling and discharges pus, and Dinggongteng dispels wind and dampness, reduces swelling and relieves pain, and the two are supplemented by rose and Zushima to dispel wind and relieve pain; Arisaema ciliata clears heat and resolves phlegm, calms wind and stops spasms, Oroxylum indicum clears the lungs and relieves sore throat, soothes the liver and harmonizes the stomach, and Qinpi clears heat and dries dampness, astringes and stops dysentery; the above are all adjuvants, which cooperate with the monarch and minister medicines in many aspects to enhance the efficacy, and have the effects of dispelling rheumatism, nourishing yin and blood, clearing heat and toxins, resolving phlegm and dampness, regulating qi, and guiding the medicine to the meridians, restraining the bias of the medicine, and making the whole prescription more perfect. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 The swelling results of the xylene-induced acute ear swelling experiment in mice in each group; compared with the model group, *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0030] Figure 2 It is the swelling inhibition rate of the xylene-induced acute auricle swelling experiment in each group of mice.

[0031] Figure 3 The figure shows the effect of the Chinese medicinal preparation of the present invention on the joint swelling degree of the rat model of knee arthritis; compared with the Model group, ***P<0.001, ****P<0.0001.

[0032] Figure 4 The analgesic effect of the Chinese medicinal preparation of the present invention on the rat model of knee arthritis; before or after administration of the model, compared with the Model group, **P<0.01, ***P<0.001, ****P<0.0001.

[0033] Figure 5 The figures show the effects of the Chinese medicinal preparation of the present invention on the levels of TNF-α (A), IL-18 (B), and IL-6 (C) in the knee joint cartilage tissue of a rat model of knee arthritis; compared with the Model group, *P<0.05, **P<0.01, ***P<0.001.

[0034] Figure 6 The figure shows the effect of the Chinese medicinal preparation of the present invention on the levels of serum factors 5-HT (A) and β-endorphin (B) in the rat model of knee arthritis; compared with the Model group, *P<0.05, **P<0.01. DETAILED DESCRIPTION

[0035] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0036] Example 1

[0037] A traditional Chinese medicine preparation for external use for relieving joint pain is composed of the following raw materials in parts by weight: 32 parts of Photinia purpurogena leaves, 30 parts of Campsis creeper, 28 parts of Siegesbeckia herba, 26 parts of Rosaceae, 24 parts of Achyranthes bidentata, 12 parts of Zushimai, 18 parts of Geranium herb, 20 parts of Tortoise shell glue, 16 parts of Cuscuta australis seeds, 16 parts of Hibiscus rosea flowers, 14 parts of Thunbergia tenuifolia, 20 parts of Arisaema ciliata, 12 parts of Oroxylum indicum, and 14 parts of Qinpi.

[0038] The above-mentioned traditional Chinese medicine preparation is used to prepare an external-use medicine for treating arthritis pain. Specifically, the raw materials are weighed according to the above-mentioned parts by weight, and medically acceptable excipients are added according to the commonly used medical preparation method to prepare an external-use dosage form. The dosage form includes black plaster, ointment, ointment, tincture, lotion, powder, hot compress pack, rubber patch, gel ointment, cream, film coating, and ion-penetrating medicine.

[0039] Example 2

[0040] The difference between this embodiment and Example 1 is that the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 20 parts of Photinia purpurogena leaves, 20 parts of Campsis creeper, 20 parts of Siegesbeckia herba, 20 parts of Rosaceae, 20 parts of Achyranthes bidentata, 10 parts of Zushima hemp, 10 parts of Geranium herb, 10 parts of Tortoise shell glue, 10 parts of Cuscuta australis seeds, 10 parts of Hibiscus rosea, 10 parts of Dinggongteng, 10 parts of Arisaema cinerea, 10 parts of Oroxylum indicum, and 10 parts of Qinpi.

[0041] Example 3

[0042] The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 40 parts of Photinia purpurogena leaves, 40 parts of Campsis creeper, 40 parts of Siegesbeckia scoparia, 40 parts of Rosaceae, 40 parts of Achyranthes bidentata, 30 parts of Zushimai, 30 parts of Geranium herb, 30 parts of Tortoise shell glue, 30 parts of Cumulus mulberry fruit, 30 parts of Hibiscus rosea, 30 parts of Dinggongteng, 30 parts of Arisaema cinerea, 30 parts of Oroxylum indicum, and 30 parts of Qinpi.

[0043] Example 4

[0044] The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 22 parts of Photinia purpurogena leaves, 22 parts of Campsis creeper, 20 parts of Siegesbeckia scoparia, 22 parts of rose, 20 parts of Achyranthes bidentata, 10 parts of Zushimai, 12 parts of Geranium herb, 12 parts of Tortoise shell glue, 12 parts of Cuscuta australis seeds, 12 parts of Hibiscus rosea flowers, 10 parts of Dinggongteng, 12 parts of Arisaema cinerea, 10 parts of Oroxylum indicum, and 10 parts of Qinpi.

[0045] Example 5

[0046] The traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 28 parts of Photinia purpurogena leaves, 36 parts of Campsis creeper, 36 parts of Siegesbeckia herba, 36 parts of Rosaceae, 32 parts of Achyranthes bidentata, 22 parts of Zushimai, 26 parts of Geranium herb, 28 parts of Tortoise shell glue, 24 parts of Cuscuta chinensis seeds, 24 parts of Hibiscus rosea flowers, 22 parts of Thunbergia dichotoma, 26 parts of Arisaema ciliata, 24 parts of Oroxylum indicum, and 22 parts of Qinpi.

[0047] Example 6

[0048] Furthermore, the Chinese medicine preparation is composed of the following raw materials in parts by weight: 25 parts of Photinia purpurogena leaves, 25 parts of Campsis creeper, 25 parts of Siegesbeckia herba, 25 parts of rose, 20 parts of Achyranthes bidentata, 10 parts of Zushima hemp, 15 parts of Geranium herb, 15 parts of Tortoise shell glue, 10 parts of Cuscuta australis seeds, 10 parts of Hibiscus rosea, 10 parts of Dinggong vine, 15 parts of Arisaema cinerea, 10 parts of Oroxylum indicum, and 10 parts of Qinpi.

[0049] Example 7

[0050] Furthermore, the Chinese medicine preparation is composed of the following raw materials in parts by weight: 35 parts of Photinia purpurogena leaves, 35 parts of Campsis creeper, 35 parts of Siegesbeckia herba, 35 parts of Rose, 30 parts of Achyranthes bidentata, 20 parts of Zushima hemp, 25 parts of Geranium herb, 25 parts of Tortoise shell glue, 20 parts of Cuscuta australis seeds, 20 parts of Hibiscus rosea, 20 parts of Dinggong vine, 25 parts of Arisaema cinerea, 20 parts of Oroxylum indicum, and 20 parts of Qinpi.

[0051] Example 8

[0052] Furthermore, the traditional Chinese medicine preparation is composed of the following raw materials in parts by weight: 28 parts of Photinia purpurogena leaves, 26 parts of Campsis creeper, 26 parts of Siegesbeckia herba, 26 parts of rose, 22 parts of Achyranthes bidentata, 14 parts of Zushima hemp, 16 parts of Geranium herb, 16 parts of Tortoise shell glue, 14 parts of Cuscuta australis seeds, 12 parts of Hibiscus rosea flowers, 12 parts of Dinggong vine, 18 parts of Arisaema cinerea, 12 parts of Oroxylum indicum, and 14 parts of Qinpi.

[0053] Example 9

[0054] Furthermore, the Chinese medicine preparation is composed of the following raw materials in parts by weight: 30 parts of Photinia purpurogena leaves, 30 parts of Campsis creeper, 28 parts of Siegesbeckia herba, 28 parts of rose, 22 parts of Achyranthes bidentata, 16 parts of Zushimao, 20 parts of Geranium herb, 20 parts of Tortoise shell glue, 16 parts of Cuscuta australis seeds, 18 parts of Hibiscus rosea, 14 parts of Dinggongteng, 22 parts of Arisaema cinerea, 16 parts of Oroxylum indicum, and 18 parts of Qinpi.

[0055] Test Example 1

[0056] Study on the anti-swelling and analgesic effects of the Chinese medicine preparation of the present invention on mice

[0057] 1 Materials and Methods

[0058] 1.1 Experimental animals

[0059] Fifty-six male C57BL / 6J mice were used for the auricle swelling experiment, and 56 female C57BL / 6J mice were used for the hot plate analgesia experiment. All mice were SPF-grade, 6 weeks old, and weighed (20 ± 2) g. The mice were acclimated for 1 week before the experiments.

[0060] 1.2 Medication

[0061] Chinese medicine ointment 1: 32 parts of Photinia pruriens leaves, 30 parts of Campsis creeper, 28 parts of Siegesbeckia scoparia, 26 parts of Rosaceae, 24 parts of Achyranthes bidentata, 12 parts of Zushima, 18 parts of Geranium, 20 parts of Tortoiseshell glue, 16 parts of Cuscuta australis seeds, 16 parts of Hibiscus rosea, 14 parts of Dinggongteng, 20 parts of Arisaema cinerea, 12 parts of Oroxylum indicum, and 14 parts of Qinpi

[0062] Chinese medicine ointment 2: 28 parts of Siegesbeckia sibiricum, 26 parts of rose flowers, 24 parts of Liuji Nu, 12 parts of Zushima, 18 parts of geranium, 20 parts of tortoise shell glue, 16 parts of paper mulberry seeds, 16 parts of hibiscus flowers, 14 parts of Dinggongteng, 20 parts of arisaema, 12 parts of oroxylum, 14 parts of Qinpi

[0063] Chinese medicine ointment 3: 32 parts of Photinia pruriens leaves, 30 parts of Campsis creeper, 24 parts of Achyranthes bidentata, 12 parts of Zushima hemp, 18 parts of Geranium, 20 parts of Tortoise shell glue, 16 parts of Cuscuta chinensis seeds, 20 parts of Arisaema cinerea, 12 parts of Oroxylum indicum, 14 parts of Qinpi

[0064] Chinese medicine ointment 4: 32 parts of Photinia pruriens leaves, 30 parts of Campsis creeper, 28 parts of Siegesbeckia scoparia, 26 parts of Rosaceae, 18 parts of Geranium, 16 parts of Cumulus chinensis seeds, 16 parts of Hibiscus rosea flowers, 14 parts of Dinggongteng, 12 parts of Oroxylum indicum, 14 parts of Qinpi

[0065] Chinese medicine ointment 5: 32 parts of Photinia pruriens leaves, 30 parts of Campsis creeper, 28 parts of Siegesbeckia scoparia, 26 parts of Rosaceae, 24 parts of Achyranthes bidentata, 12 parts of Zushima, 20 parts of Tortoise shell glue, 16 parts of Hibiscus rosea, 14 parts of Dinggongteng, 20 parts of Arisaema ciliata

[0066] Preparation: Weigh each ingredient according to the above weight ratio, crush through a 200-mesh sieve, mix thoroughly, add 0.2 times the weight of honey, and stir until a thick, non-flowing paste forms. Microwave for 30 seconds before use, preferably to warm slightly. Prepare immediately.

[0067] 1.3 Mouse ear swelling experiment

[0068] Fifty-six healthy male mice were randomly divided into seven groups based on body weight balance: the model group and experimental groups 1-5, with eight mice in each group. Each group received a topical application of the corresponding drug and the right auricle once daily. Experimental groups 1-5 were treated with Chinese herbal ointment 1-5 (0.1 g / mouse), respectively. The model group received no treatment. Drugs were administered continuously at a fixed time daily for 7 days. Two hours after the last dose, 0.05 mL of xylene was evenly applied to the anterior and posterior sides of the right auricle of each mouse. The mice were allowed to move freely in a fume hood for 30 minutes before being sacrificed by dexterity. An 8 mm diameter ear punch was used to punch 8 mm pieces at the same locations on the left and right auricles of the mice and the weights were measured. The degree of swelling and swelling inhibition rate were calculated for each group.

[0069] Swelling degree (mg) = right ear auricle mass - left ear auricle mass

[0070] Swelling inhibition rate (%) = (mean swelling of the right ear auricle in the model group - mean swelling of the right ear auricle in the treatment group) / mean swelling of the right ear auricle in the model group × 100%

[0071] 1.4 Hot plate analgesia experiment

[0072] Fifty-six healthy male mice were randomly divided into seven weight-balanced groups (model group and experimental groups 1-5), each with eight mice. The mice were cleaned with 75% alcohol at the 1 / 3 point from the tail tip. The corresponding drug was then applied to the tail. After 0.5 minutes, the mice were fixed in a mouse holder. The tail, protruding from the center hole of the rear cover, was held hanging naturally and placed on a small round stick. The experiment began after the mice were calm. A positive reaction was defined as a transient tail-flicking reaction to light-induced thermal pain. Pain thresholds were measured before dosing, with a limit of 3 to 13 seconds. Mice with pre-dose pain thresholds <3 seconds or >13 seconds were discarded. The experimental grouping and dosing schedule were the same as in "1.3." Seven days after dosing, mice were placed on a light analgesia at 0.5, 1.5, and 3 hours, and the duration of the tail-flick was recorded (those >16.5 seconds were counted as 16.5 seconds). The basal pain threshold was measured as the mean of three pain thresholds before drug administration and statistically processed.

[0073] 1.5 Statistical methods

[0074] SPSS 22.0 statistical software was used for data analysis. Measurement data were expressed as mean ± standard deviation (xˉ ± s). Comparisons between two groups were performed using the t-test, and comparisons between multiple groups were performed using analysis of variance. P < 0.05 was considered statistically significant.

[0075] 2 Results

[0076] 2.1 Comparison of the experimental results of xylene-induced acute ear swelling in mice of different groups

[0077] The results are as follows Figure 1 As shown, compared with the model group, the auricle swelling of test groups 1-5 decreased to varying degrees, with test group 1 showing the greatest decrease in auricle swelling, with the difference being extremely significant (P < 0.0001). The swelling inhibition rates of test groups 1-5 were 61.89%, 38.17%, 40.15%, 43.14%, and 48.11%, respectively, with test group 1 having the highest swelling inhibition rate. These results demonstrate that the Chinese herbal preparation of the present invention has a significant effect in reducing and inhibiting xylene-induced acute auricle swelling in mice, particularly in the absence of Photinia fraseri and Campsis virgatum, which significantly weakens the Chinese herbal preparation's swelling-reducing and swelling-inhibiting effects.

[0078] 2.2 Comparison of hot plate analgesia test results among mice groups

[0079] The results are shown in Table 1. Before administration, there was no significant difference in the pain threshold of mice between the groups (P>0.05). 0.5 h after administration, the pain threshold of mice in test groups 1, 2, 4, and 5 increased significantly compared with the model group (P<0.05, P<0.01). 1.5 h after administration, the pain threshold of mice in test groups 1, 2, and 5 increased significantly compared with the model group (P<0.05, P<0.01). 3 h after administration, the pain threshold of mice in test group 1 increased significantly compared with the model group (P<0.05).

[0080] The above results show that the Chinese medicine preparation of the present invention has a good analgesic effect, can achieve rapid analgesia, and maintain a long-lasting analgesic effect. When the individual components of the Chinese medicine preparation of the present invention are missing (the Chinese medicine preparations used in test groups 2-5), the analgesic effect is significantly reduced. In particular, when the Chinese medicine preparation lacks Siegesbeckia, Rosa rugosa, Hibiscus rosea, and Thunbergia truncatula, the analgesic effect is far inferior to that of the Chinese medicine preparation of the present invention.

[0081] Table 1 Hot plate analgesia experimental results

[0082]

[0083] Note: Compared with the model group, *P<0.05, **P<0.01; within each group, compared with before administration, # P<0.05, ## P<0.01.

[0084] Test Example 2

[0085] Study on the anti-inflammatory and analgesic effects of the Chinese medicine preparation of the present invention on a rat model of knee arthritis

[0086] 1 Materials and Methods

[0087] 1.1 Experimental animals

[0088] 50 SPF male rats, weighing (200±20) g; mice were adaptively fed for 1 week before the experiment.

[0089] 1.2 Trial Drugs

[0090] The Chinese medicine ointment of the present invention includes: 32 parts of Photinia purpurogena leaves, 30 parts of Campsis creeper, 28 parts of Herba Siegesbeckiae, 26 parts of Rosaceae, 24 parts of Achyranthes bidentatae, 12 parts of Zushimai, 18 parts of Geranium, 20 parts of Tortoiseshell glue, 16 parts of Cumulus cuspidatus seeds, 16 parts of Hibiscus hibiscus flowers, 14 parts of Caulis dichotoma, 20 parts of Arisaema cinereae, 12 parts of Oroxylum indicum, and 14 parts of Fraxinus officinalis. Each raw material is weighed according to the above parts by weight, crushed through a 200-mesh sieve, mixed evenly, and then 0.2 times the weight of honey is added. Stir evenly until a thick, non-flowing paste is obtained. Heat in a microwave for 30 seconds before use, preferably to slightly warm it. Prepare as needed.

[0091] Positive control drug: Yunnan Baiyao tincture.

[0092] 1.3 Animal modeling and grouping

[0093] Rats were randomly divided into five groups, each with 10 rats: a negative control group (Sham group), a model group (Model group), a positive control group (AC group), a low-dose group (Low group), and a high-dose group (High group). Each group received an intraperitoneal injection of 2% sodium pentobarbital (0.3 mL / 100 g). After disinfection of the right knee joint of the model rats, 0.1 mL of 5 mg / mL sodium methyl acetate (MIA) was injected into the knee joint cavity. The sham group received an equal volume of phosphate buffered saline. Starting on the second day after MIA injection, the AC group applied 5 mL / kg of Yunnan Baiyao tincture to the right knee joint. The Low (0.5 g / rat) and High (1 g / rat) groups applied a thick layer of the Chinese medicinal ointment of the present invention to the right knee joint and wrapped it with sterile gauze for at least 1 hour before removing the ointment. The sham group applied an equal volume of normal saline. Each group received medication for 7 consecutive days, twice daily.

[0094] 1.4 Detection indicators and methods

[0095] 1.4.1 Detection of rat knee joint swelling

[0096] 24 hours after the last administration of the drug, the diameters of the left and right knee joints of all rats in each group were measured with a vernier caliper, and the change in the diameter of the right knee joint was used as an indicator to evaluate the degree of knee joint swelling.

[0097] Joint swelling (mm) = right knee joint diameter 24 hours after the last dose - left knee joint diameter

[0098] 1.4.2 Rat knee joint pain threshold test

[0099] All rats in each group underwent thermal pain threshold testing before modeling and 0.5 h after drug administration. Thermal withdrawal latency (TWL) was measured using the Hargreaves method using a PL-200 analgesia instrument. SD rats were placed in a plexiglass box and pre-acclimated for 10 min. A movable light beam at 45% spot intensity was then continuously irradiated onto the mid-plantar surface of the rats. The TWL was measured from the start of irradiation until the rats lifted their legs and licked their paws. Each rat underwent five measurements, with a 10-min interval between measurements. The average value was calculated.

[0100] 1.4.3 Detection of TNF-α, IL-18, and IL-6 levels in knee cartilage tissue

[0101] After the experiment, the rats were killed and the cartilage tissue of the right knee joint was obtained. The levels of TNF-α, IL-18, and IL-6 in the knee joint cartilage tissue were detected according to the instructions of the ELISA kit.

[0102] 1.4.4 Detection of pain factor levels in rat serum

[0103] After the experiment, the abdominal aorta blood of the rats was collected and the levels of serum factors 5-hydroxytryptamine (5-HT) and β-endorphin (β-EP) were detected by ELISA.

[0104] 1.5 Statistical analysis

[0105] SPSS 22.0 statistical software was used for data analysis. Measurement data were expressed as mean ± standard deviation (xˉ ± s). Comparisons between two groups were performed using the t-test, and comparisons between multiple groups were performed using analysis of variance. P < 0.05 was considered statistically significant.

[0106] 2 Results

[0107] 2.1 Effect of the Chinese medicine preparation of the present invention on joint swelling in a rat model of knee arthritis

[0108] Compared with the Sham group, the right knee joint swelling of the rats in the Model group was obvious, and the difference was extremely significant (P<0.0001). Compared with the Model group, the right knee joint swelling of the rats in the AC group and the Low group was significantly decreased, and the difference was significant (P<0.001). The right knee joint swelling of the rats in the High group was significantly decreased, and the difference was extremely significant (P<0.0001).

[0109] 2.2 Analgesic effect of the Chinese medicine preparation of the present invention on the rat model of knee arthritis

[0110] Before modeling and drug administration, there were no significant differences in TML values among the rats in each group (P>0.05). After drug administration, the pain threshold of rats in the Model group was significantly lower than that in the Sham group (P<0.0001). Compared with the Model group, the pain threshold of rats in the AC and Low groups was significantly increased (P<0.01), and the pain threshold of rats in the High group was significantly increased (P<0.0001).

[0111] 2.3 Effect of the Chinese medicine preparation of the present invention on the levels of TNF-α, IL-18, and IL-6 in the knee joint cartilage tissue of a rat model of knee arthritis

[0112] Compared with the Sham group, the inflammatory factors TNF-α, IL-18, and IL-6 in the knee joint cartilage tissue of the rats in the Model group were significantly increased (P<0.001, P<0.0001); compared with the Model group, the inflammatory factor TNF-α in the knee joint cartilage tissue of the rats in the AC group and Low group was significantly decreased (P<0.01), and IL-18 and IL-6 were significantly decreased (P<0.05); compared with the Model group, the inflammatory factor TNF-α in the knee joint cartilage tissue of the rats in the High group was extremely significantly decreased (P<0.001), and IL-18 and IL-6 were significantly decreased (P<0.01).

[0113] 2.4 Effect of the Chinese herbal preparation of the present invention on the levels of serum factors 5-hydroxytryptamine (5-HT) and β-endorphin (β-EP) in rat models of knee arthritis

[0114] Compared with the Sham group, the serum 5-HT content of rats in the Model group was significantly increased (P<0.001), and the β-EP content was significantly decreased (P<0.01). Compared with the Model group, the serum 5-HT content of rats in the Low group was significantly increased (P<0.05), the serum 5-HT content of rats in the AC group was significantly increased (P<0.01), and the serum 5-HT content of rats in the High group was significantly increased (P<0.001). Compared with the Model group, the serum β-EP content of rats in the AC and Low groups increased, but there was no significant difference (P>0.05), while the serum β-EP content of rats in the High group was significantly increased (P<0.05).

[0115] 3 Conclusion

[0116] The above results show that the traditional Chinese medicine preparation of the present invention has a good therapeutic effect on a rat model of knee arthritis, effectively reducing joint swelling, and can also reduce the levels of inflammatory factors such as TNF-α, IL-18, and IL-6, showing excellent anti-inflammatory effects. It can also increase the pain threshold, reduce 5-HT levels, and increase β-EP levels, showing good analgesic and pain-relieving effects. The traditional Chinese medicine preparation of the present invention is expected to provide a new treatment method and drug for treating pain caused by knee arthritis.

[0117] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A Chinese medicine preparation for external use for relieving joint pain, characterized in that: The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 20-40 parts of photinia leaves, 20-40 parts of trumpet creeper, 20-40 parts of siegesbeckia herba, 20-40 parts of rose flowers, 20-40 parts of lily of the valley, 10-30 parts of zushimai, 10-30 parts of geranium, 10-30 parts of tortoise shell glue, 10-30 parts of mulberry fruit, 10-30 parts of hibiscus flowers, 10-30 parts of dinggongteng, 10-30 parts of arisaema, 10-30 parts of oroxylum bungeana, and 10-30 parts of qinpi.

2. A Chinese medicine preparation for external use for relieving joint pain according to claim 1, characterized in that: The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 25-35 parts of photinia leaves, 25-35 parts of trumpet creeper, 25-35 parts of siegesbeckia herba, 25-35 parts of rose, 20-30 parts of lily of the valley, 10-20 parts of zushimai, 15-25 parts of geranium, 15-25 parts of tortoise shell glue, 10-20 parts of mulberry fruit, 10-20 parts of hibiscus flower, 10-20 parts of dinggong vine, 15-25 parts of arisaema, 10-20 parts of oroxylum, and 10-20 parts of qinpi.

3. A Chinese medicine preparation for external use for relieving joint pain according to claim 1, characterized in that: The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 32 parts of Photinia purpurogena leaves, 30 parts of Campsis creeper, 28 parts of Siegesbeckia herba, 26 parts of rose, 24 parts of Achyranthes bidentata, 12 parts of Zushimai, 18 parts of Geranium herb, 20 parts of Tortoise shell glue, 16 parts of Cuscuta chinensis seeds, 16 parts of Hibiscus rosea flowers, 14 parts of Thunbergia tenuifolia, 20 parts of Arisaema ciliata, 12 parts of Oroxylum indicum, and 14 parts of Qinpi.

4. Use of the Chinese medicine preparation according to any one of claims 1 to 3 in the preparation of an external-use medicament for treating arthritis pain, characterized in that: The Chinese medicinal raw materials are weighed according to the above-mentioned parts by weight, and medically acceptable excipients are added according to the commonly used medical preparation methods to prepare external dosage forms, which include black plasters, ointments, tinctures, lotions, powders, hot compresses, rubber patches, gel ointments, creams, film coatings, and ion-penetrating drugs.

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