External traditional Chinese medicine composition for treating gout, swelling and arthritis as well as preparation method and application of external traditional Chinese medicine composition

Abstract

The invention provides an external traditional Chinese medicine composition for treating gout, swelling and arthritis as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines. The external traditional Chinese medicine composition is prepared from the following components in parts by mass: 10 to 35 parts of radix clematidis, 5 to 25 parts of radix zanthoxyli, 15 to 35 parts of cortex phellodendri, 5 to 25 parts of herba lysimachiae, 10 to 35 parts of rhizoma alismatis, 40 to 90 parts of radix notoginseng, 40 to 90 parts of radix gentianae macrophyllae, 40 to 90 parts of rhizoma seu radix notopterygii and 40 to 90 parts of rhizoma zingiberis. The externally-applied traditional Chinese medicine composition obtained through triple compounding of radix clematidis, radix zanthoxyli, cortex phellodendri, herba lysimachiae, radix gentianae macrophyllae and rhizoma seu radix notopterygii according to a specific proportion is few in medicine composition, good in acting effect, easy to store, convenient to carry and capable of effectively treating gout, swelling, pain and arthritis.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to an external Chinese medicine composition for treating gout, swelling, pain and arthritis, and a preparation method and application thereof. Background Art

[0002] Gout is a group of metabolic diseases caused by purine metabolism disorder, excessive uric acid production and / or reduced uric acid excretion, and continuous increase in blood uric acid levels, resulting in urate crystals deposited in joints and soft tissues. Modern medicine is still in the symptomatic treatment stage for the treatment of gout. According to the mode of action of the drug, chemical drugs can be divided into five categories: (1) drugs that inhibit granulocyte infiltration, such as colchicine; (2) drugs that inhibit uric acid production, such as the xanthine oxidase inhibitor allopurinol; (3) drugs that promote uricosuric acid excretion, such as probenecid, sulfamethoxazole, and benzbromarone; (4) non-steroidal anti-inflammatory drugs, such as naproxen, indomethacin, phenylbutazone or hydroxyphenylbutazone, piroxicam; (5) glucocorticoids, such as prednisone. Many of these drugs are old drugs developed in the 1950s and 1960s, with significant side effects, such as drug irritation, allergic reactions, hepatotoxicity, bone marrow suppression, etc., which make it difficult for patients to continue using them. Therefore, finding highly effective and low-toxic anti-gout drugs from traditional Chinese medicine has always been a hot topic in research.

[0003] Chinese invention patent publication number CN108714203A discloses a Chinese medicine composition wine extract for external treatment of gout, swelling and pain in arthritis. Clematis, Zanthoxylum bungeana, part A of Panax notoginseng powder, safflower, centipede, phellodendron, mint, frankincense, myrrh, Tripterygium wilfordii, Curcuma zedoaria, earthworm, lycopodiella cuneata, scorpion, rhubarb, Eucommia bark, Dipsacus asper and Achyranthes bidentata are sealed and soaked for 2-4 months with liquor containing ethanol concentration of more than 60% by volume, and then the residue is filtered to obtain a filtrate, and then part B of Panax notoginseng powder, Gentiana macrophylla powder, Notopterygium wilfordii powder and dried ginger powder are added to the filtrate, and then the mixture is sealed and soaked for 2-4 months, taken out and filtered, and the filtrate is a Chinese medicine composition wine extract for external treatment of gout, swelling and pain in arthritis. The aforementioned pharmaceutical composition has more medicinal taste, and the effect needs to be further improved. Chinese invention patent CN112826888B discloses a Chinese medicine composition for gout, its preparation method and application, including 10-35 parts of oriental rhizome, 5-20 parts of plantain seeds, 5-20 parts of angelica dahurica, 5-20 parts of parsley, 2-10 parts of ephedra, 0.01-1 parts of menthol, 0.05-4 parts of borneol, and 1-10 parts of licorice. The Chinese medicine composition has a good uric acid-lowering effect on the zebrafish hyperuricemia model induced by potassium oxonate combined with xanthine. However, since the composition contains menthol and borneol, the storage conditions are relatively strict.

[0004] Therefore, there is an urgent need to provide an external Chinese medicine composition for treating gout, swelling, pain and arthritis, which has few medicinal ingredients, good effects, is easy to store and convenient to carry. Summary of the invention

[0005] In view of the existing technology, the inventors have obtained a Chinese medicine composition for external use in clinical practice that has few medicinal ingredients, good effects, is easy to store and carry, and can effectively treat gout, swelling and pain, and arthritis by triple compounding of Clematis chinensis and Zanthoxylum bungeanum, Phellodendron amurense and Lysimachia chinensis, and Gentiana macrophylla and Notopterygium wilfordii in specific proportions. The composition has the advantages of small medicinal ingredients, good effects, easy storage, and convenient carrying.

[0006] The first aspect of the present invention is to provide an external Chinese medicine composition for treating gout, swelling and pain, and arthritis. The external Chinese medicine composition comprises the following raw materials by weight: 10-35 parts of Clematidis, 5-25 parts of Zanthoxylum bungeanum, 15-35 parts of Phellodendron chinense, 5-25 parts of Lysimachia scabra, 10-35 parts of Alisma orientalis, 40-90 parts of Panax notoginseng, 40-90 parts of Gentiana macrophylla, 40-90 parts of Notopterygium wilfordii and 40-90 parts of dried ginger.

[0007] Preferably, the external Chinese medicine composition comprises the following raw materials by weight: 10-25 parts of Clematidis, 5-15 parts of Zanthoxylum bungeanum, 15-25 parts of Phellodendron chinense, 5-20 parts of Lysimachia scabra, 10-30 parts of Alisma orientalis, 50-80 parts of Panax notoginseng, 50-80 parts of Gentiana macrophylla, 50-80 parts of Notopterygium wilfordii and 50-80 parts of dried ginger.

[0008] Preferably, the external Chinese medicine composition comprises the following raw materials by weight: 15 parts of Clematidis, 10 parts of Zanthoxylum bungeanum, 20 parts of Phellodendron chinense, 15 parts of Lysimachia scabra, 20 parts of Alisma orientalis, 50 parts of Panax notoginseng, 65 parts of Gentiana macrophylla, 80 parts of Notopterygium wilfordii and 50 parts of dried ginger.

[0009] Preferably, the mass ratio of the Clematis chinensis to the Zanthoxylum bungeanum is 2-3:1-3.

[0010] Preferably, the mass ratio of Gentiana macrophylla to Notopterygium wilfordii is 1:1-2.

[0011] Preferably, the weight ratio of Phellodendron chinense to Lysimachia scabra is 1-2:1.

[0012] The second aspect of the present invention is to provide a method for preparing the above-mentioned external Chinese medicine composition, the preparation method comprising the following steps: (1) adding clematis root, lily scutellaria baicalensis, phellodendron amurense, lysimachia chinensis, oriental bark and part of panax notoginseng to ethanol aqueous solution for reflux extraction to obtain an extract; (2) crushing the remaining part of Panax notoginseng, Gentiana macrophylla, Notopterygium wilfordii and dried ginger to obtain medicinal material powder; (3) Add the extract obtained in step (1) to the medicinal material powder obtained in step (2), seal and soak for 2-4 months, then take out and filter to obtain the filtrate.

[0013] Preferably, in step (1), the volume fraction of ethanol in the ethanol aqueous solution is 60%-80%, and the extraction is performed 2-3 times, with each extraction time being 1-2 hours.

[0014] Preferably, the pulverizing in step (2) is to pulverize the remaining part of Panax notoginseng, Gentiana macrophylla, Notopterygium wilfordii and dried ginger into medium powder or fine powder.

[0015] The third aspect of the present invention relates to the use of the above-mentioned external Chinese medicine composition or the external Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of gouty arthritis drugs.

[0016] Preferably, the application includes the following steps: first use an electric hair dryer to dilate capillaries, then apply the Chinese medicine composition to the knee joints and ankle joints of the legs, then to the lumbar vertebrae joints of the waist, and finally to the shoulders and the big vertebrae.

[0017] Compared with the prior art, the present invention has the following beneficial effects: through the triple compounding of Clematis chinensis and Zanthoxylum bungeanum, Phellodendron chinense and Lysimachia chinensis, Gentiana macrophylla and Notopterygium wilfordii, the anti-inflammatory and analgesic effects are better, and gout, swelling and pain, and arthritis can be effectively treated. DETAILED DESCRIPTION

[0018] The following non-limiting examples can enable those skilled in the art to more fully understand the present invention, but do not limit the present invention in any way. The following content is merely an exemplary description of the scope of the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, which should also fall within the scope of the present invention.

[0019] Embodiment 1: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 15 parts of clematis root, 10 parts of zanthoxylum bungeanum, 20 parts of phellodendron, 15 parts of schizonepeta tenuifolia, 20 parts of oriental water chestnut, 50 parts of notoginseng, 65 parts of gentiana macrophylla, 80 parts of notopterygium wilfordii and 50 parts of dried ginger.

[0020] Preparation method: (1) Reflux extraction of Radix Clematis, Radix Zanthoxylum, Rhizoma Zanthoxylum, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix Notoginseng with 70% by volume ethanol aqueous solution for 2 times, wherein the amount of ethanol aqueous solution added each time is 10 times the total weight of the medicinal materials, and filtering and combining the filtrate to obtain an extract; (2) Grinding 25 parts of Radix Notoginseng, Radix Gentianae Macrophyllae, Radix Notopterygii and dried ginger into fine powder to obtain medicinal material powder; (3) Adding the extract obtained in step (1) to the medicinal material powder obtained in step (2), sealing and soaking for 3 months, taking out, filtering and obtaining the filtrate.

[0021] Embodiment 2: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 10 parts of clematis root, 5 parts of zanthoxylum bungeanum, 15 parts of phellodendron, 5 parts of lysimachia scabra, 10 parts of oriental water chestnut, 50 parts of notoginseng, 50 parts of gentiana macrophylla, 50 parts of notopterygium and 50 parts of dried ginger.

[0022] Preparation method: Same as Example 1.

[0023] Embodiment 3: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 25 parts of clematis root, 15 parts of zanthoxylum bungeanum, 25 parts of phellodendron, 20 parts of lysimachia scabra, 30 parts of oriental water chestnuts, 80 parts of notoginseng, 80 parts of gentiana macrophylla, 80 parts of notopterygium wilfordii and 80 parts of dried ginger.

[0024] Preparation method: (1) Reflux extraction of Clematis chinensis, Zanthoxylum bungeanum, Phellodendron amurense, Lysimachia chinensis, Alisma orientalis and 40 parts of Panax notoginseng with 70% by volume aqueous ethanol solution for 2 times, wherein the amount of ethanol solution added each time is 10 times the total weight of the medicinal materials, filter, combine the filtrate and obtain an extract; (2) Grind 40 parts of Panax notoginseng, Gentiana macrophylla, Notopterygium wilfordii and dried ginger into fine powder to obtain medicinal material powder; (3) Add the extract obtained in step (1) to the medicinal material powder obtained in step (2), seal and soak for 3 months, then take out, filter and obtain the filtrate.

[0025] Comparative Example 1: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 25 parts of Zanthoxylum bungeanum, 20 parts of Phellodendron chinense, 15 parts of Lysimachia scabra, 20 parts of Alisma orientalis, 50 parts of Panax notoginseng, 65 parts of Gentiana macrophylla, 80 parts of Notopterygium wilfordii and 50 parts of dried ginger.

[0026] Preparation method: (1) Reflux extraction of Zanthoxylum bungeanum, Phellodendron amurense, Lysimachia chinensis, Alisma orientalis and 25 parts of Panax notoginseng with 70% by volume aqueous ethanol solution for 2 times, wherein the amount of ethanol solution added each time is 10 times the total weight of the medicinal materials, filter, combine the filtrate and obtain an extract; (2) Grind 25 parts of Panax notoginseng, Gentiana macrophylla, Notopterygium wilfordii and dried ginger into fine powder to obtain medicinal material powder; (3) Add the extract obtained in step (1) to the medicinal material powder obtained in step (2), seal and soak for 3 months, then take out, filter and obtain the filtrate.

[0027] The difference from Example 1 is that the composition of Comparative Example 1 does not contain the raw material Clematis chinensis, which is added to Zanthoxylum bungeana. The rest is the same as Example 1.

[0028] Comparative Example 2: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 25 parts of clematis root, 20 parts of phellodendron, 15 parts of schizonepeta, 20 parts of orientalis, 50 parts of notoginseng, 65 parts of gentiana macrophylla, 80 parts of notopterygium and 50 parts of dried ginger.

[0029] Preparation method: (1) Reflux extraction of Radix Clematis, Phellodendron amurense, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix Notoginseng with 70% by volume ethanol aqueous solution for 2 times, wherein the amount of ethanol aqueous solution added each time is 10 times the total weight of the medicinal materials, filter, combine the filtrate and obtain an extract; (2) Grind 25 parts of Radix Notoginseng, Radix Gentianae Macrophyllae, Radix Notopterygii and dried ginger into fine powder to obtain medicinal material powder; (3) Add the extract obtained in step (1) to the medicinal material powder obtained in step (2), seal and soak for 3 months, then take out, filter and obtain the filtrate.

[0030] The difference from Example 1 is that the composition of Comparative Example 2 does not contain the raw material Zanthoxylum bungeana, and the raw material Zanthoxylum bungeana is added to Clematidis.

[0031] Comparative Example 3: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 15 parts of clematis root, 10 parts of dianthus fragrans, 35 parts of lycopodiella cuneata, 20 parts of oriental arisaema, 50 parts of notoginseng, 65 parts of gentiana macrophylla, 80 parts of notopterygium wilfordii and 50 parts of dried ginger.

[0032] Preparation method: (1) Reflux extraction of Clematis chinensis, Zanthoxylum bungeanum, Lysimachia chinensis, Rhizoma Alismatis and 25 parts of Panax notoginseng with 70% by volume ethanol aqueous solution for 2 times, wherein the amount of ethanol aqueous solution added each time is 10 times the total weight of the medicinal materials, filtering, combining the filtrate to obtain an extract; (2) Grinding 25 parts of Panax notoginseng, Gentiana macrophylla, Notopterygium wilfordii and dried ginger into fine powder to obtain medicinal material powder; (3) Adding the extract obtained in step (1) to the medicinal material powder obtained in step (2), sealing and soaking for 3 months, taking out, filtering and obtaining the filtrate.

[0033] The difference from Example 1 is that the composition of Comparative Example 3 does not contain the raw material Phellodendron amurense, and the raw material Phellodendron amurense is added to Lysimachia sibiricum. The rest is the same as Example 1.

[0034] Comparative Example 4: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 15 parts of clematis root, 10 parts of zanthoxylum bungeanum, 35 parts of phellodendron, 20 parts of oriental water chestnuts, 50 parts of notoginseng, 65 parts of gentiana macrophylla, 80 parts of notopterygium and 50 parts of dried ginger.

[0035] Preparation method: (1) Reflux extraction of Clematis chinensis, Zanthoxylum bungeanum, Phellodendron amurense, Rhizoma Alismatis and 25 parts of Panax notoginseng with 70% by volume ethanol aqueous solution for 2 times, wherein the amount of ethanol aqueous solution added each time is 10 times the total weight of the medicinal materials, filter, combine the filtrate, and obtain an extract; (2) Grind 25 parts of Panax notoginseng, Gentiana macrophylla, Notopterygium wilfordii and dried ginger into fine powder to obtain medicinal material powder; (3) Add the extract obtained in step (1) to the medicinal material powder obtained in step (2), seal and soak for 3 months, then take out, filter, and obtain the filtrate.

[0036] The difference from Example 1 is that the composition of Comparative Example 4 does not contain the raw material Lysimachia sibiricum, and the raw material Lysimachia sibiricum is added to Phellodendron amurense. The rest is the same as Example 1.

[0037] Comparative Example 5: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 15 parts of clematis root, 10 parts of zanthoxylum bungeanum, 20 parts of phellodendron, 15 parts of nephrodisiac, 20 parts of oriental water chestnut, 50 parts of notoginseng, 145 parts of notopterygium and 50 parts of dried ginger.

[0038] Preparation method: (1) Reflux extraction of Clematis chinensis, Zanthoxylum bungeanum, Phellodendron amurense, Lysimachia chinensis, Rhizoma Alismatis and 25 parts of Panax notoginseng with 70% by volume aqueous ethanol solution for 2 times, wherein the amount of ethanol solution added each time is 10 times the total weight of the medicinal materials, filter, combine the filtrate, and obtain an extract; (2) Grind 25 parts of Panax notoginseng, Notopterygium wilfordii and dried ginger into fine powder to obtain medicinal material powder; (3) Add the extract obtained in step (1) to the medicinal material powder obtained in step (2), seal and soak for 3 months, then take out, filter, and obtain the filtrate.

[0039] The difference from Example 1 is that the composition of Comparative Example 5 does not contain the raw material Gentiana macrophylla, and the raw material Gentiana macrophylla is added to Notopterygium incisum.

[0040] Comparative Example 6: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 15 parts of clematis root, 10 parts of zanthoxylum bungeanum, 20 parts of phellodendron, 15 parts of lysimachia scabra, 20 parts of orientalis, 50 parts of notoginseng, 145 parts of gentiana macrophylla and 50 parts of dried ginger.

[0041] Preparation method: (1) Reflux extraction of Clematis chinensis, Zanthoxylum bungeanum, Phellodendron amurense, Lysimachia chinensis, Rhizoma Alismatis and 25 parts of Panax notoginseng with 70% by volume aqueous ethanol solution for 2 times, wherein the amount of ethanol solution added each time is 10 times the total weight of the medicinal materials, filter, combine the filtrate and obtain an extract; (2) Grind 25 parts of Panax notoginseng, Gentiana macrophylla and dried ginger into fine powder to obtain medicinal material powder; (3) Add the extract obtained in step (1) to the medicinal material powder obtained in step (2), seal and soak for 3 months, then take out, filter and obtain the filtrate.

[0042] The difference from Example 1 is that the composition of Comparative Example 6 does not contain the raw material Notopterygium wilfordii, and the raw material Notopterygium wilfordii is added to Gentiana macrophylla. The rest is the same as Example 1.

[0043] Comparative Example 7: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 5 parts of clematis root, 20 parts of lianmianzhen, 20 parts of phellodendron, 15 parts of lysimachia scabra, 20 parts of oriental water chestnut, 50 parts of panax notoginseng, 65 parts of gentiana macrophylla, 80 parts of notopterygium and 50 parts of dried ginger.

[0044] Preparation method: (1) Reflux extraction of Radix Clematis, Radix Zanthoxylum, Rhizoma Zanthoxylum, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix Notoginseng with 70% by volume ethanol aqueous solution for 2 times, wherein the amount of ethanol aqueous solution added each time is 10 times the total weight of the medicinal materials, and filtering and combining the filtrate to obtain an extract; (2) Grinding 25 parts of Radix Notoginseng, Radix Gentianae Macrophyllae, Radix Notopterygii and dried ginger into fine powder to obtain medicinal material powder; (3) Adding the extract obtained in step (1) to the medicinal material powder obtained in step (2), sealing and soaking for 3 months, taking out, filtering and obtaining the filtrate.

[0045] The difference from Example 1 is that the dosage and relative proportion of Clematis chinensis and Zanthoxylum bungeanum are different. In Example 1, there are 15 parts of Clematis chinensis and 10 parts of Zanthoxylum bungeanum, and the ratio between the two is 3:2, while in Comparative Example 7, there are 5 parts of Clematis chinensis and 20 parts of Zanthoxylum bungeanum, and the ratio between the two is 1:4, and the rest is the same as Example 1.

[0046] Comparative Example 8: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 15 parts of clematis root, 10 parts of zanthoxylum bungeanum, 5 parts of phellodendron, 30 parts of lysimachia scabra, 20 parts of oriental water chestnuts, 50 parts of notoginseng, 65 parts of gentiana macrophylla, 80 parts of notopterygium wilfordii and 50 parts of dried ginger.

[0047] Preparation method: (1) Reflux extraction of Radix Clematis, Radix Zanthoxylum, Rhizoma Zanthoxylum, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix Notoginseng with 70% by volume ethanol aqueous solution for 2 times, wherein the amount of ethanol aqueous solution added each time is 10 times the total weight of the medicinal materials, and filtering and combining the filtrate to obtain an extract; (2) Grinding 25 parts of Radix Notoginseng, Radix Gentianae Macrophyllae, Radix Notopterygii and dried ginger into fine powder to obtain medicinal material powder; (3) Adding the extract obtained in step (1) to the medicinal material powder obtained in step (2), sealing and soaking for 3 months, taking out, filtering and obtaining the filtrate.

[0048] The difference from Example 1 is that the dosage and relative proportion of Phellodendron chinense and Lysimachia chinensis are different. In Example 1, there are 20 parts of Phellodendron chinense and 15 parts of Lysimachia chinensis, and the ratio between the two is 4:3, while in Comparative Example 8, there are 5 parts of Phellodendron chinense and 30 parts of Lysimachia chinensis, and the ratio between the two is 1:6, and the rest is the same as Example 1.

[0049] Comparative Example 9: A Chinese medicinal composition for external use for treating gout, swelling and pain, and arthritis. The Chinese medicinal composition for external use comprises the following raw materials by weight: 15 parts of clematis root, 10 parts of zanthoxylum bungeanum, 20 parts of phellodendron, 15 parts of schizonepeta tenuifolia, 20 parts of oriental water chestnut, 50 parts of notoginseng, 115 parts of gentiana macrophylla, 30 parts of notopterygium and 50 parts of dried ginger.

[0050] Preparation method: (1) Reflux extraction of Radix Clematis, Radix Zanthoxylum, Rhizoma Zanthoxylum, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix Notoginseng with 70% by volume ethanol aqueous solution for 2 times, wherein the amount of ethanol aqueous solution added each time is 10 times the total weight of the medicinal materials, and filtering and combining the filtrate to obtain an extract; (2) Grinding 25 parts of Radix Notoginseng, Radix Gentianae Macrophyllae, Radix Notopterygii and dried ginger into fine powder to obtain medicinal material powder; (3) Adding the extract obtained in step (1) to the medicinal material powder obtained in step (2), sealing and soaking for 3 months, taking out, filtering and obtaining the filtrate.

[0051] The difference from Example 1 is that the dosage and relative proportion of Gentiana macrophylla and Notopterygium incisum are different. In Example 1, there are 65 parts of Gentiana macrophylla and 80 parts of Notopterygium incisum, and the ratio between the two is 13:16, while in Comparative Example 9, there are 115 parts of Gentiana macrophylla and 30 parts of Notopterygium incisum, and the ratio between the two is 23:6. The rest is the same as Example 1.

[0052] Comparative Example 10: The composition extract of Comparative Example 10 was prepared according to the raw materials and preparation method of Example 1 in Chinese invention patent application CN108714203A, specifically: the raw materials, by mass, included 30 parts of Clematis, 20 parts of Zanthoxylum bungeanum, 45 parts of Panax notoginseng powder part A, 30 parts of Carthamus tinctorius, 15 parts of Scolopendra subspinipes, 30 parts of Phellodendron chinense, 28 parts of Mentha arvense, 10 parts of Frankincense, 10 parts of Myrrh, 28 parts of Trillium, 30 parts of Curcuma zedoaria, 13 parts of Pheretima, 16 parts of Lycopodiella cuneata, 20 parts of Scorpio, 20 parts of Rhubarb, 20 parts of Eucommia bark, 20 parts of Dipsacus asper, 40 parts of Achyranthes bidentata, 65 parts of Panax notoginseng powder part B, 65 parts of Gentiana macrophylla powder, 65 parts of Notopterygium wilfordii powder, and 65 parts of dried ginger powder. Preparation method: Seal and soak clematis, lianmianzhen, part A of notoginseng powder, safflower, centipede, phellodendron, mint, frankincense, myrrh, trillium, curcuma, earthworm, lycopodiella cuneata, scorpion, rhubarb, eucommia bark, dipsacus root and achyranthes bidentata in white wine containing 75% ethanol by volume for 3 months, then filter the residue to obtain the filtrate, add part B of notoginseng powder, gentiana macrophylla powder, notopterygium wilfordii powder and dried ginger powder to the filtrate, seal and soak for 3 months, then take out and filter. The filtrate is a traditional Chinese medicine composition wine extract for external treatment of gout, swelling and pain in arthritis.

[0053] Experimental Example 1: Wistar rats, all male, weighing 180-220 g, were fed for 3 days and randomly divided into groups according to their weight, with 10 rats in each group. The groups were normal control group, model control group, and treatment group (positive control group, Example 1-3 groups, Comparative Example 1-10 groups). Except for the normal control group, rats in the other groups inhaled isoflurane for about 5 seconds to achieve general anesthesia, and then drew 50 mg·mL of isoflurane with a sterile insulin syringe. -125 μL of sodium urate suspension was injected into the ankle joint at a 30° angle to the inside of the right hind ankle joint of the rat. The bulging of the opposite side of the joint cavity indicated that the model was successful. Rats in the normal control group were injected with an equal volume of sterile saline according to the above method. After the model was successfully established, the treatment group began to apply the drug locally, remove the hair on the right hind limbs of the rats, and administer the drug once in the morning and afternoon each day. Example 1-3 groups and comparative example 1-10 groups were each given the corresponding drug at a dose of 1g crude drug / kg rat body weight, and the drug solution was heated in a 38°C water bath and then applied to the right ankle joint and surrounding areas of the rat; the positive control group was given Voltaren at a dose of 0.01g / kg rat body weight, which was applied to the right ankle joint and surrounding areas of the rat. The drug was administered continuously for 28 days.

[0054] Plantar swelling measurement: Three rats were randomly selected from each experimental group before modeling, 2 weeks after modeling, 1 week after drug administration, 2 weeks after drug administration, 3 weeks after drug administration, and 4 weeks after drug administration. Closed marking lines were drawn on the bulge of the right hind limb ankle joint with an oily marker pen, and the diameter of the marked joint was measured with a digital vernier caliper. The joint swelling rate was calculated according to the following formula:

[0055] After the experiment, the rats were killed by inhalation of an overdose of isoflurane. With the right posterior ankle joint as the center, 1 cm of joint tissue was cut, and the fur and muscle were carefully removed. The joint was placed in a test tube containing 1 mL of normal saline, and the joint was broken and placed in ice water for 15 min at 3000 r / min. -1 After centrifugation for 15 min, the supernatant was stored in a -20°C refrigerator for subsequent testing. ELISA kits were used to detect the levels of IL-1β, IL-6, and TNF-α in joint tissues.

[0056] The experimental results are shown in Tables 1 and 2.

[0057] Table 1: Effects on joint swelling in rats

[0058] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, each treatment group *P<0.05, **P<0.01; compared with the Example 1 group, each treatment group & indicates P < 0.05, && Indicates P<0.01.

[0059] According to the results in Table 1, after 2 weeks of modeling, the rat joints were significantly swollen, which was significantly different from the normal control group (P<0.01); after administration, the swelling rate of the treatment group was significantly lower than that of the model group, and the difference was statistically significant (P<0.05) or significantly different (P<0.01) compared with the model control group; compared with Example 1, the effects of the positive control group and Example 2-3 groups were equivalent to those of Example 1 group, and the effects of the comparative drug 1-9 groups were worse than those of Example 1, and the difference was statistically significant (P<0.05). The effect of the comparative example 10 group was significantly worse than that of Example 1, and the difference in the effects of the two groups was significant (P<0.01). It is suggested that the Chinese medicine composition of the present invention can inhibit the joint swelling caused by gouty arthritis in rats, and the therapeutic effect is better than that of the drugs in the comparative example 1-10 groups.

[0060] Table 2: Effects on inflammatory factors in joint tissues of rats with gouty arthritis

[0061] Note: Compared with the normal control group, **P<0.01; compared with the model control group, each drug group # P<0.05, ## P<0.01; Compared with the group in Example 1, the & indicates P < 0.05, && Indicates P<0.01.

[0062] According to the results in Table 2, the content of inflammatory factors IL-1β, IL-6 and TNF-α between the model control group and the normal control group was significantly different (P<0.01). Compared with the model control group, the drugs in the positive control group, Examples 1-3, and Comparative Examples 1-10 all had different degrees of positive regulation on the content of IL-1β, IL-6 and TNF-α, and the differences were statistically significant (P<0.05) or significantly different (P<0.01); compared with Example 1, there was no statistically significant difference between Example 2, Example 3 and the positive control group and Example 1, while there was a statistically significant difference between Comparative Examples 1-9 and Example 1 (P<0.05), and there was a statistically significant difference between the drugs in Comparative Example 10 and Example 1 (P<0.05) or significantly different (P<0.01). It shows that the raw material composition and raw material ratio in the present composition have an effect on the positive regulation of the content of IL-1β, IL-6 and TNF-α, and the synergistic combination of the raw material composition and ratio in the composition of the present invention can achieve the best effect.

[0063] Experimental Example 2: Analgesic effect: ICR mice, all female, weighing 18-22g, were adaptively raised for 3 days, and then subjected to hot plate pain threshold screening to screen mice with a pain threshold between 5-20s. The screening method is: place the mouse in a hot plate analgesia preheated to 55±0.5℃, and use the latency of the mouse licking its hind foot as the pain threshold index. The qualified mice were randomly divided into a blank control group, a positive control group, Example 1-3 groups, and Comparative Example 1-10 groups, with 10 mice in each group. The blank control group was given 1g / kg of mouse body weight of distilled water, the positive control group was given 0.01g / kg of mouse body weight of Voltaren, and the Example 1-3 groups and Comparative Example 1-10 groups were each given the corresponding drugs, with a dose of 1g crude drug / kg of mouse body weight. Each group of mice was given the drug once a day, and the drug solution was heated in a 38℃ water bath and then applied to both hind feet of the mice for 5 consecutive days.

[0064] Before administration, the basal pain threshold of each group of mice was measured, and the average pain threshold of each group was calculated. After the last administration, the pain threshold of mice was measured at 60min, 120min, and 180min after administration. If the latency of the animal's licking paw reaction was extended to more than 30s under the analgesic effect, 30s was used as the upper limit of the latency of licking paw to avoid skin burns due to prolonged licking.

[0065] The experimental results are shown in Table 3.

[0066] Table 3: Analgesic effect of Chinese medicine composition

[0067] Note: Compared with the blank control group, # P<0.05, ## P<0.01; Compared with the group in Example 1, the & P<0.05, && P<0.01.

[0068] It can be seen from the experimental results in Table 3 that when Voltaren was administered for 60min and 120min, the pain threshold of mice could be significantly prolonged, and the pain threshold was significantly improved compared with the blank control group, with a significant difference (p<0.01), while at 180min, Voltaren could not prolong the pain threshold of mice, and the difference in pain threshold was not significant compared with the blank control group; and the Chinese medicine compositions of Examples 1-3 and Comparative Examples 1-10 of the present invention could significantly prolong the pain threshold of mice at 60min, 120min, and 180min after administration, and the difference was statistically significant compared with the blank control group (P <0.05) or significant difference (P<0.01); compared with Example 1, Examples 2-3 and the positive control drug had equivalent analgesic effects at 60 min and 120 min after administration, while at 180 min after administration, the analgesic effects of Examples 1-3 were significantly better than those of the positive drug, with significant difference (P<0.01), while the analgesic effects of the comparative examples 1-10 at 60 min, 120 min, and 180 min after administration were weaker than those of Example 1, and the differences were statistically significant (P<0.05) or significant (P<0.01).

[0069] According to the experimental results, the Chinese medicine composition of the present invention has a certain analgesic effect, the effect is better than the comparative example, and the analgesic time is longer, which is better than the positive control drug.

[0070] Clinical application examples: Case 1: Mr. Wang, male, 51 years old, unemployed, due to eating more seafood and irregular lifestyle, uric acid 516 µmol / L, total cholesterol 7.2, on May 6, 2022, suddenly developed redness, swelling and severe pain in the ankle, applied the liquid of Example 1, first used electric hair dryer to dilate capillaries, first applied the liquid of Example 1 to the knee joints and ankle joints of the legs, then to the lumbar vertebrae joints of the waist, and finally to the shoulders and the big vertebrae. The redness and swelling were relieved in 1 hour, and he could walk on the same day. After 1 month of treatment, once a day, the uric acid was reduced to the normal value of 164 µmol / L, and no recurrence was observed.

[0071] Case 2: Zhao, female, 39 years old, business, due to long-term stay-up, beer and seafood, uric acid 537µmol / L, total cholesterol 6.9, on July 3, 2023, the metatarsophalangeal joints suddenly became red and swollen. The liquid of Example 1 was applied. First, the capillaries were expanded by electric hair dryer. The liquid of Example 1 was first applied to the knee joints and ankle joints of the legs, then to the lumbar vertebrae joints of the waist, and finally to the shoulders and the big vertebrae. The swelling and pain were relieved in 40 minutes, and the patient drove away 1 hour later. After 1 month of treatment, once a day, the uric acid level was reduced to the normal value of 121µmol / L, and no recurrence was observed.

[0072] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for external use for treating gout, swelling and pain, and arthritis, comprising the following raw materials by weight: 10-35 parts of Clematidis, 5-25 parts of Zanthoxylum bungeanum, 15-35 parts of Phellodendron chinense, 5-25 parts of Lysimachia scabra, 10-35 parts of Alisma orientalis, 40-90 parts of Panax notoginseng, 40-90 parts of Gentiana macrophylla, 40-90 parts of Notopterygium wilfordii and 40-90 parts of dried ginger.

2. The Chinese medicine composition for external use according to claim 1, characterized in that: The external Chinese medicine composition comprises the following raw materials by weight: 10-25 parts of clematis, 5-15 parts of zanthoxylum bungeanum, 15-25 parts of phellodendron, 5-20 parts of schizonepeta tenuifolia, 10-30 parts of oriental water chestnuts, 50-80 parts of notoginseng, 50-80 parts of gentiana macrophylla, 50-80 parts of notopterygium wilfordii and 50-80 parts of dried ginger.

3. The Chinese medicine composition for external use according to claim 1, characterized in that: The external Chinese medicine composition comprises the following raw materials by weight: 15 parts of clematis, 10 parts of zanthoxylum bungeanum, 20 parts of phellodendron, 15 parts of lycopodiella cuneata, 20 parts of oriental water chestnut, 50 parts of notoginseng, 65 parts of gentiana macrophylla, 80 parts of notopterygium and 50 parts of dried ginger.

4. The Chinese medicine composition for external use according to claim 1, characterized in that: The mass ratio of the Clematis chinensis to Zanthoxylum bungeanum is 2-3:1-3.

5. The Chinese medicine composition for external use according to claim 1, characterized in that: The mass ratio of the gentiana macrophylla and the notopterygium wilfordii is 1:1-2.

6. The Chinese medicine composition for external use according to claim 1, characterized in that: The weight ratio of the Phellodendron chinense to the Lysimachia sibiricum is 1-2:

1.

7. A method for preparing the external Chinese medicine composition according to any one of claims 1 to 6, the preparation method comprising the following steps: (1) adding clematis root, lily scutellaria baicalensis, phellodendron amurense, lysimachia chinensis, oriental bark and part of panax notoginseng to ethanol aqueous solution for reflux extraction to obtain an extract; (2) crushing the remaining part of Panax notoginseng, Gentiana macrophylla, Notopterygium wilfordii and dried ginger to obtain medicinal material powder; (3) Add the extract obtained in step (1) to the medicinal material powder obtained in step (2), seal and soak for 2-4 months, then take out and filter to obtain the filtrate.

8. The preparation method according to claim 7, characterized in that: In the step (1), the volume fraction of ethanol in the ethanol aqueous solution is 60%-80%, and the extraction is performed 2-3 times, with each extraction time being 1-2 hours.

9. The preparation method according to claim 7, characterized in that: The crushing in step (2) is to crush Panax notoginseng, Gentiana macrophylla, Notopterygium wilfordii and dried ginger into medium powder or fine powder.

10. An application of the external Chinese medicine composition as described in any one of claims 1 to 6 or the external Chinese medicine composition prepared by the preparation method as described in any one of claims 7 to 9 in the preparation of drugs for treating gout, swelling and pain in arthritis, the application comprising the following steps: firstly using electric hair dryer to dilate capillaries, then applying the Chinese medicine composition to the knee joints and ankle joints of the legs, then to the lumbar vertebrae joints of the waist, and finally to the shoulders and the big vertebrae.

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