An external-use traditional Chinese medicine composition for treating gouty arthralgia and a preparation method and application thereof

Abstract

The application provides a kind of external use traditional Chinese medicine composition for treating gouty arthritis and its preparation method and application, it is related to the technical field of traditional Chinese medicine.The external use traditional Chinese medicine composition comprises, by mass fraction, radix tripterygii wilfordii 10-35 parts, zanthoxylum 5-25 parts, phellodendron 15-35 parts, herba lycii 5-25 parts, alisma 10-35 parts, panax notoginseng 40-90 parts, gentiana 40-90 parts, notopterygium 40-90 parts and dried ginger 40-90 parts.Through the triple recombination of radix tripterygii wilfordii and zanthoxylum, phellodendron and herba lycii, gentiana and notopterygium, the external use traditional Chinese medicine composition obtained under a specific ratio has few medicinal ingredients, good effect, easy storage and convenient carrying, and can effectively treat gouty arthritis.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to an external traditional Chinese medicine composition for treating gouty arthritis and a preparation method and application thereof. BACKGROUND

[0002] Gout is a group of metabolic diseases caused by deposition of urate crystals in joints and soft tissues due to purine metabolism disorder, excessive uric acid production and / or reduced uric acid excretion, and sustained increase in blood uric acid levels. Modern medicine for the treatment of gout is still in the symptomatic treatment stage. According to the mode of action of drugs, chemical drugs can be divided into five categories: (1) Inhibiting granulocyte infiltration drugs, such as colchicine; (2) Inhibiting uric acid production drugs, such as xanthine oxidase inhibitor allopurinol; (3) Promoting uric acid excretion drugs, such as probenecid, benzbromarone, benzobromarone; (4) Non-steroidal anti-inflammatory drugs, such as naproxen, indomethacin, phenylbutazone or hydroxyphenylbutazone, indomethacin; (5) Glucocorticoids, such as prednisone. Many of these varieties are old drugs developed in the 1950s and 1960s, and have greater side effects, such as drug irritation, allergic reactions, liver and kidney toxicity, and bone marrow suppression, making it difficult for patients to continue to use them. Therefore, it has been a research hotspot to find anti-gout drugs with high efficiency and low toxicity from traditional Chinese medicine.

[0003] Chinese patent CN108714203A discloses a traditional Chinese medicine composition liquor extract for external use in treating gouty arthritis. The traditional Chinese medicine composition is prepared by sealing and soaking Weilingxian, Liangmianzhen, Sanqipian A, Honghua, Wugong, Huangbai, Bohe, Ru-xiang, Mo-yao, Sanlieng, E-zhu, Shenzheng- ca, Quanxie, Dahuang, Duzhong, Xuduan and Niuxi in liquor containing ethanol with a concentration of 60% by volume fraction for 2-4 months, then filtering the residue to obtain the filtrate, adding Sanqipian B, Qian- jie powder, Qianghuo powder and Ganjiang powder to the filtrate, sealing and soaking for another 2-4 months, and then filtering to obtain the traditional Chinese medicine composition liquor extract for external use in treating gouty arthritis. The aforementioned traditional Chinese medicine composition has too many ingredients, and the effect needs to be further improved. Chinese patent CN112826888B discloses a traditional Chinese medicine composition for gout and a preparation method and application thereof, which comprises 10-35 parts of Alisma orientalis, 5-20 parts of Plantago asiatica, 5-20 parts of Radix Angelicae Dahuricae, 5-20 parts of Paris polyphylla, 2-10 parts of Ephedra sinica, 0.01-1 part of menthol, 0.05-4 parts of borneol, and 1-10 parts of Glycyrrhiza uralensis. The traditional Chinese medicine composition has a good uric acid-lowering effect on the zebrafish model of high uric acid caused by potassium oxonicate and xanthine. However, the composition contains menthol and borneol, which are strict in storage conditions.

[0004] Therefore, there is an urgent need to provide an external traditional Chinese medicine composition for treating gouty arthritis, which has fewer ingredients, good effect, is easy to store, and is convenient to carry. SUMMARY

[0005] In view of the prior art, the inventors have obtained, in clinical practice, a composition of external use of Chinese medicine for treating gouty arthritis, which has few medicinal ingredients, good effect, easy storage and convenient carrying, by triple combination of Radix Clematidis and Radix Stephaniae Tetrandrae, Cortex Phellodendri and Herba Lysimachiae, and Radix Gentianae Macrophyllae and Radix et Rhizoma Notopterygii in specific proportions.

[0006] The first aspect of the present application provides a composition of external use of Chinese medicine for treating gouty arthritis, which comprises the following raw materials by weight: Radix Clematidis 10-35 parts, Radix Stephaniae Tetrandrae 5-25 parts, Cortex Phellodendri 15-35 parts, Herba Lysimachiae 5-25 parts, Rhizoma Alpiniae Oxophyllae 10-35 parts, Radix et Rhizoma Notopterygii 40-90 parts, Radix et Rhizoma Notopterygii 40-90 parts and Rhizoma Zingiberis Recens 40-90 parts.

[0007] Preferably, the composition of external use of Chinese medicine comprises the following raw materials by weight: Radix Clematidis 10-25 parts, Radix Stephaniae Tetrandrae 5-15 parts, Cortex Phellodendri 15-25 parts, Herba Lysimachiae 5-20 parts, Rhizoma Alpiniae Oxophyllae 10-30 parts, Radix et Rhizoma Notopterygii 50-80 parts, Radix et Rhizoma Notopterygii 50-80 parts and Rhizoma Zingiberis Recens 50-80 parts.

[0008] Preferably, the composition of external use of Chinese medicine comprises the following raw materials by weight: Radix Clematidis 10-25 parts, Radix Stephaniae Tetrandrae 5-15 parts, Cortex Phellodendri 15-25 parts, Herba Lysimachiae 5-20 parts, Rhizoma Alpiniae Oxophyllae 10-30 parts, Radix et Rhizoma Notopterygii 50-80 parts, Radix et Rhizoma Notopterygii 50-80 parts and Rhizoma Zingiberis Recens 50-80 parts.

[0009] Preferably, the mass ratio of Radix Clematidis and Radix Stephaniae Tetrandrae is 2-3:1-3.

[0010] Preferably, the mass ratio of Radix et Rhizoma Notopterygii and Radix et Rhizoma Notopterygii is 1:1-2.

[0011] Preferably, the weight ratio of Cortex Phellodendri and Herba Lysimachiae is 1-2:1.

[0012] The second aspect of the present application provides a preparation method of the above-mentioned composition of external use of Chinese medicine, which comprises the following steps:

[0013] (1) adding Radix Clematidis, Radix Stephaniae Tetrandrae, Cortex Phellodendri, Herba Lysimachiae, Rhizoma Alpiniae Oxophyllae and part of Radix et Rhizoma Notopterygii into an aqueous ethanol solution for reflux extraction to obtain an extract;

[0014] (2) crushing the remaining part of Radix et Rhizoma Notopterygii, Radix Gentianae Macrophyllae, Radix et Rhizoma Notopterygii and Rhizoma Zingiberis Recens to obtain medicinal material powder;

[0015] (3) adding the extract obtained in step (1) into the medicinal material powder obtained in step (2), sealing and soaking for 2-4 months, then taking out, filtering, and obtaining the filtrate.

[0016] 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.

[0017] Preferably, the pulverization 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.

[0018] 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 medicaments for gout, swelling and pain, and arthritis.

[0019] Preferably, the application includes the following steps: first using an electric hair dryer to dilate capillaries, then applying the Chinese medicine composition to the knee joints and ankle joints of the legs, then applying it to the lumbar joints of the waist, and finally applying it to the shoulders and the big vertebrae.

[0020] Compared with the prior art, the present invention has the following beneficial effects: through the triple combination of Clematidis and Zanthoxylum bungeanum, Phellodendron amurense and Lysimachia chinensis, Gentiana macrophylla and Notopterygium wilfordii, it has better anti-inflammatory and analgesic effects and can effectively treat gout, swelling and pain in arthritis. DETAILED DESCRIPTION

[0021] The following non-limiting examples are provided to enable those skilled in the art to more fully understand the present invention, but are not intended to limit the present invention in any way. The following contents are merely illustrative of the scope of the present invention, and those skilled in the art may make various changes and modifications to the present invention based on the disclosed contents, which should also fall within the scope of the present invention.

[0022] Example 1:

[0023] The invention discloses an external Chinese medicinal composition for treating gout, swelling, pain and arthritis. The external Chinese medicinal composition comprises the following raw materials in parts by weight: 15 parts of clematis root, 10 parts of dianthus fragrans, 20 parts of phellodendron amurense, 15 parts of scutellaria baicalensis, 20 parts of oriental dwarfism root, 50 parts of panax notoginseng, 65 parts of gentiana macrophylla, 80 parts of notopterygium wilfordii and 50 parts of dried ginger.

[0024] Preparation method: (1) Reflux extraction of Radix Clematis, Rhizoma Zanthoxyli, Radix Phellodendri, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix Notoginseng with 70% by volume ethanol aqueous solution twice, with the amount of ethanol aqueous solution added each time being 10 times the total weight of the medicinal materials, filtering, 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.

[0025] Example 2:

[0026] An external use traditional Chinese medicine composition for treating gouty arthritis, the external use traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of radix clematidis, 5 parts of zanthoxylum bungeanum, 15 parts of phellodendri, 5 parts of herba lycopus, 10 parts of rhizoma notoginseng, 50 parts of radix gentianae, 50 parts of rhizoma notopterygii and 50 parts of zingiberis.

[0027] Preparation method: same as example 1.

[0028] Example 3:

[0029] An external use traditional Chinese medicine composition for treating gouty arthritis, the external use traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of radix clematidis, 5 parts of zanthoxylum bungeanum, 15 parts of phellodendri, 5 parts of herba lycopus, 10 parts of rhizoma notoginseng, 50 parts of radix gentianae, 50 parts of rhizoma notopterygii and 50 parts of zingiberis.

[0030] Preparation method: (1) reflux extraction of radix clematidis, zanthoxylum bungeanum, phellodendri, herba lycopus, rhizoma notoginseng and 40 parts of rhizoma notoginseng with 70% ethanol aqueous solution for 2 times, the adding amount of ethanol aqueous solution is 10 times of the total weight of the medicinal materials each time, filtration, combination of the filtrates, and the extraction liquid is obtained; (2) crushing rhizoma notoginseng 40 parts, radix gentianae, rhizoma notopterygii and zingiberis into fine powder, and the medicinal material powder is obtained; (3) adding the extraction liquid obtained in step (1) into the medicinal material powder obtained in step (2), sealing and soaking for 3 months, taking out, filtration, and the filtrate is obtained.

[0031] Comparative example 1:

[0032] An external use traditional Chinese medicine composition for treating gouty arthritis, the external use traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of radix clematidis, 5 parts of zanthoxylum bungeanum, 15 parts of phellodendri, 5 parts of herba lycopus, 10 parts of rhizoma notoginseng, 50 parts of radix gentianae, 50 parts of rhizoma notopterygii and 50 parts of zingiberis.

[0033] Preparation method: (1) reflux extraction of radix clematidis, zanthoxylum bungeanum, phellodendri, herba lycopus, rhizoma notoginseng and 40 parts of rhizoma notoginseng with 70% ethanol aqueous solution for 2 times, the adding amount of ethanol aqueous solution is 10 times of the total weight of the medicinal materials each time, filtration, combination of the filtrates, and the extraction liquid is obtained; (2) crushing rhizoma notoginseng 40 parts, radix gentianae, rhizoma notopterygii and zingiberis into fine powder, and the medicinal material powder is obtained; (3) adding the extraction liquid obtained in step (1) into the medicinal material powder obtained in step (2), sealing and soaking for 3 months, taking out, filtration, and the filtrate is obtained.

[0034] The difference from example 1 is that the composition of comparative example 1 does not contain the raw material radix clematidis, and the amount of radix clematidis is added to zanthoxylum bungeanum. The others are the same as example 1.

[0035] Comparative example 2:

[0036] An external use traditional Chinese medicine composition for treating gouty arthritis, the external use traditional Chinese medicine composition comprises the following raw materials in parts by weight: 25 parts of Radix Tripetali, 20 parts of Cortex Phellodendri, 15 parts of Herba Lysimachiae, 20 parts of Rhizoma Alismatis, 50 parts of Radix Notoginseng, 65 parts of Radix Gentianae Macrophyllae, 80 parts of Radix et Rhizoma Notopterygii and 50 parts of Rhizoma Zingiberis.

[0037] Preparation method: (1) Radix Tripterygii, Cortex Phellodendri, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix Notoginseng are extracted with 70% ethanol aqueous solution by reflux extraction for 2 times, the adding amount of ethanol aqueous solution is 10 times of the total weight of the medicinal materials each time, filtration is performed, the filtrates are combined to obtain an extract; (2) 25 parts of Radix Notoginseng, Radix Gentianae Macrophyllae, Radix et Rhizoma Notopterygii and Rhizoma Zingiberis are crushed into fine powder to obtain medicinal material powder; (3) the extract obtained in step (1) is added to the medicinal material powder obtained in step (2), sealed and soaked for 3 months, taken out, filtered, and the filtrate is obtained.

[0038] The difference from example 1 is that the composition of comparative example 2 does not contain the raw material Herba Hedyotis Diffusae, and the amount thereof is added to Radix Tripterygii. The others are the same as example 1.

[0039] Comparative example 3:

[0040] An external use traditional Chinese medicine composition for treating gouty arthritis, the external use traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of Radix Tripterygii, 10 parts of Herba Hedyotis Diffusae, 35 parts of Herba Lysimachiae, 20 parts of Rhizoma Alismatis, 50 parts of Radix Notoginseng, 65 parts of Radix Gentianae Macrophyllae, 80 parts of Radix et Rhizoma Notopterygii and 50 parts of Rhizoma Zingiberis.

[0041] Preparation method: (1) Radix Tripterygii, Herba Hedyotis Diffusae, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix Notoginseng are extracted with 70% ethanol aqueous solution by reflux extraction for 2 times, the adding amount of ethanol aqueous solution is 10 times of the total weight of the medicinal materials each time, filtration is performed, the filtrates are combined to obtain an extract; (2) 25 parts of Radix Notoginseng, Radix Gentianae Macrophyllae, Radix et Rhizoma Notopterygii and Rhizoma Zingiberis are crushed into fine powder to obtain medicinal material powder; (3) the extract obtained in step (1) is added to the medicinal material powder obtained in step (2), sealed and soaked for 3 months, taken out, filtered, and the filtrate is obtained.

[0042] The difference from example 1 is that the composition of comparative example 3 does not contain the raw material Cortex Phellodendri, and the amount thereof is added to Herba Lysimachiae. The others are the same as example 1.

[0043] Comparative example 4:

[0044] An external use traditional Chinese medicine composition for treating gouty arthritis, the external use traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of Radix Tripterygii, 10 parts of Herba Hedyotis Diffusae, 35 parts of Cortex Phellodendri, 20 parts of Rhizoma Alismatis, 50 parts of Radix Notoginseng, 65 parts of Radix Gentianae Macrophyllae, 80 parts of Radix et Rhizoma Notopterygii and 50 parts of Rhizoma Zingiberis.

[0045] Preparation method: (1) the radix clematidis, the two-faced needle, the phellodendron, the alisma and 25 parts of the panax notoginseng are extracted with 70% ethanol aqueous solution by reflux extraction twice, the adding amount of the ethanol aqueous solution is 10 times of the total weight of the medicinal materials each time, filtration, the filtrate is combined to obtain the extraction; (2) the panax notoginseng 25 parts, the gentiana macrophylla, the nardostachys and the dried ginger are crushed into fine powder to obtain the medicinal material powder; (3) the extraction obtained in step (1) is added to the medicinal material powder obtained in step (2), sealed and soaked for 3 months, taken out, filtered, and the filtrate is obtained.

[0046] The difference from example 1 is that the composition of comparative example 4 does not contain the raw material herba lycopus lucidi, which is added to the phellodendron. The others are the same as example 1.

[0047] Comparative example 5:

[0048] An external traditional Chinese medicine composition for treating gouty arthritis, the external traditional Chinese medicine composition comprises the following raw materials in parts by weight: radix clematidis 15 parts, two-faced needle 10 parts, phellodendron 20 parts, herba lycopus lucidi 15 parts, alisma 20 parts, panax notoginseng 50 parts, nardostachys 145 parts and dried ginger 50 parts.

[0049] Preparation method: (1) the radix clematidis, the two-faced needle, the phellodendron, the herba lycopus lucidi, the alisma and 25 parts of the panax notoginseng are extracted with 70% ethanol aqueous solution by reflux extraction twice, the adding amount of the ethanol aqueous solution is 10 times of the total weight of the medicinal materials each time, filtration, the filtrate is combined to obtain the extraction; (2) the panax notoginseng 25 parts, the nardostachys and the dried ginger are crushed into fine powder to obtain the medicinal material powder; (3) the extraction obtained in step (1) is added to the medicinal material powder obtained in step (2), sealed and soaked for 3 months, taken out, filtered, and the filtrate is obtained.

[0050] The difference from example 1 is that the composition of comparative example 5 does not contain the raw material gentiana macrophylla, which is added to the nardostachys. The others are the same as example 1.

[0051] Comparative example 6:

[0052] An external traditional Chinese medicine composition for treating gouty arthritis, the external traditional Chinese medicine composition comprises the following raw materials in parts by weight: radix clematidis 15 parts, two-faced needle 10 parts, phellodendron 20 parts, herba lycopus lucidi 15 parts, alisma 20 parts, panax notoginseng 50 parts, gentiana macrophylla 145 parts and dried ginger 50 parts.

[0053] Preparation method: (1) the radix clematidis, the two-faced needle, the phellodendron, the herba lycopus lucidi, the alisma and 25 parts of the panax notoginseng are extracted with 70% ethanol aqueous solution by reflux extraction twice, the adding amount of the ethanol aqueous solution is 10 times of the total weight of the medicinal materials each time, filtration, the filtrate is combined to obtain the extraction; (2) the panax notoginseng 25 parts, the gentiana macrophylla and the dried ginger are crushed into fine powder to obtain the medicinal material powder; (3) the extraction obtained in step (1) is added to the medicinal material powder obtained in step (2), sealed and soaked for 3 months, taken out, filtered, and the filtrate is obtained.

[0054] The difference from Example 1 is that the composition of Comparative Example 6 does not contain raw material Rhizoma et Radix Notopterygii, and the amount thereof is added to Gentiana macrophylla. The others are the same as Example 1.

[0055] Comparative Example 7:

[0056] An external traditional Chinese medicine composition for treating gouty arthritis, which comprises the following raw materials by weight: Radix Tricampytris 5 parts, Radix et Rhizoma Lindernae 20 parts, Cortex Phellodendri 20 parts, Herba Lysimachiae 15 parts, Rhizoma Alismatis 20 parts, Radix et Rhizoma Notoginseng 50 parts, Gentiana macrophylla 65 parts, Rhizoma et Radix Notopterygii 80 parts and Rhizoma Zingiberis 50 parts.

[0057] Preparation method: (1) Radix Tricampytris, Radix et Rhizoma Lindernae, Cortex Phellodendri, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix et Rhizoma Notoginseng are extracted with 70% ethanol aqueous solution by reflux extraction for 2 times, and the amount of ethanol aqueous solution added each time is 10 times the total weight of the medicinal materials, filtered, and the filtrates are combined to obtain an extract; (2) 25 parts of Radix et Rhizoma Notoginseng, Gentiana macrophylla, Rhizoma et Radix Notopterygii and Rhizoma Zingiberis are crushed into fine powder to obtain medicinal material powder; (3) the extract obtained in step (1) is added to the medicinal material powder obtained in step (2), sealed and soaked for 3 months, taken out, filtered, and the filtrate is obtained.

[0058] The difference from Example 1 is that the amount and relative ratio of Radix Tricampytris and Radix et Rhizoma Lindernae are different, and in Example 1, Radix Tricampytris is 15 parts and Radix et Rhizoma Lindernae is 10 parts, and the ratio of the two is 3:2, while in Comparative Example 7, Radix Tricampytris is 5 parts and Radix et Rhizoma Lindernae is 20 parts, and the ratio of the two is 1:4, and the others are the same as Example 1.

[0059] Comparative Example 8:

[0060] An external traditional Chinese medicine composition for treating gouty arthritis, which comprises the following raw materials by weight: Radix Tricampytris 15 parts, Radix et Rhizoma Lindernae 10 parts, Cortex Phellodendri 5 parts, Herba Lysimachiae 30 parts, Rhizoma Alismatis 20 parts, Radix et Rhizoma Notoginseng 50 parts, Gentiana macrophylla 65 parts, Rhizoma et Radix Notopterygii 80 parts and Rhizoma Zingiberis 50 parts.

[0061] Preparation method: (1) Radix Tricampytris, Radix et Rhizoma Lindernae, Cortex Phellodendri, Herba Lysimachiae, Rhizoma Alismatis and 25 parts of Radix et Rhizoma Notoginseng are extracted with 70% ethanol aqueous solution by reflux extraction for 2 times, and the amount of ethanol aqueous solution added each time is 10 times the total weight of the medicinal materials, filtered, and the filtrates are combined to obtain an extract; (2) 25 parts of Radix et Rhizoma Notoginseng, Gentiana macrophylla, Rhizoma et Radix Notopterygii and Rhizoma Zingiberis are crushed into fine powder to obtain medicinal material powder; (3) the extract obtained in step (1) is added to the medicinal material powder obtained in step (2), sealed and soaked for 3 months, taken out, filtered, and the filtrate is obtained.

[0062] The difference from Example 1 is that the amount and relative ratio of Cortex Phellodendri and Herba Lysimachiae are different, and in Example 1, Cortex Phellodendri is 20 parts and Herba Lysimachiae is 15 parts, and the ratio of the two is 4:3, while in Comparative Example 8, Cortex Phellodendri is 5 parts and Herba Lysimachiae is 30 parts, and the ratio of the two is 1:6, and the others are the same as Example 1.

[0063] Comparative Example 9:

[0064] An external use traditional Chinese medicine composition for treating gouty arthralgia, the external use traditional Chinese medicine composition comprises the following raw materials in parts by weight: Radix Tricampyli 15 parts, Zanthoxylum nitidum 10 parts, Phellodendron amurense 20 parts, Herba Lysimachiae 15 parts, Rhizoma Alismatis 20 parts, Radix Notoginseng 50 parts, Gentiana 115 parts, Notopterygium 30 parts, and Rhizoma Zingiberis 50 parts.

[0065] Preparation method: (1) reflux extract Radix Tricampyli, Zanthoxylum nitidum, Phellodendron amurense, Herba Lysimachiae, Rhizoma Alismatis, and 25 parts of Radix Notoginseng with 70% ethanol aqueous solution for 2 times, the adding amount of ethanol aqueous solution is 10 times of the total weight of the medicinal materials each time, filter, combine the filtrates, and obtain the extract; (2) crush 25 parts of Radix Notoginseng, Gentiana, Notopterygium, and Rhizoma Zingiberis into fine powder, and obtain the medicinal material powder; (3) add the extract obtained in step (1) to the medicinal material powder obtained in step (2), seal, soak for 3 months, take out, filter, and the filtrate is obtained.

[0066] The difference from Example 1 is that the amount and relative ratio of Gentiana and Notopterygium are different, in Example 1, Gentiana is 65 parts and Notopterygium is 80 parts, the ratio of the two is 13:16, while in Comparative Example 9, Gentiana is 115 parts and Notopterygium is 30 parts, the ratio of the two is 23:6, and the rest is the same as Example 1.

[0067] Comparative Example 10:

[0068] The extract of the composition of Comparative Example 10 is prepared according to the raw materials and preparation method of Example 1 in Chinese patent application CN108714203A, specifically: the raw materials include Radix Tricampyli 30 parts, Zanthoxylum nitidum 20 parts, Radix Notoginseng powder A part 45 parts, Herba Carthami 30 parts, Solenopsis 15 parts, Phellodendron amurense 30 parts, Herba Menthae 28 parts, Olibanum 10 parts, Commiphora 10 parts, Herba Sparganii 28 parts, Curcuma 30 parts, Pheretima 13 parts, Herba Sedi 16 parts, Scorpio 20 parts, Radix et Rhizoma Rhei 20 parts, Eucommia 20 parts, Dipsacus 20 parts, Radix Hedysari 40 parts, Radix Notoginseng powder B part 65 parts, Gentiana powder 65 parts, Notopterygium powder 65 parts, and Rhizoma Zingiberis powder 65 parts, in parts by mass. The preparation method is: seal Radix Tricampyli, Zanthoxylum nitidum, Radix Notoginseng powder A part, Herba Carthami, Solenopsis, Phellodendron amurense, Herba Menthae, Olibanum, Commiphora, Herba Sparganii, Curcuma, Pheretima, Herba Sedi, Scorpio, Radix et Rhizoma Rhei, Eucommia, Dipsacus, and Radix Hedysari with liquor containing ethanol with a concentration of 75% by volume to soak for 3 months, then filter the dregs, obtain the filtrate, add Radix Notoginseng powder B part, Gentiana powder, Notopterygium powder, and Rhizoma Zingiberis powder to the filtrate, seal again, soak for 3 months, take out, filter, and the filtrate is the traditional Chinese medicine composition liquor extract for external use in treating gouty arthralgia.

[0069] Experimental Example 1:

[0070] Wistar rats, full male, body weight 180-220g, after adaptive feeding for 3 days, according to the body weight, randomly grouping, 10 rats in each group. Group respectively as normal control group, model control group, treatment group (positive control group, example 1-3 group, comparative example 1-10 group). Except the normal control group, after the rats in the rest groups inhale isoflurane about 5s to achieve the effect of general anesthesia, 25μL of 50mg·mL -1 Sodium urate suspension 25μL is sucked by sterilized insulin syringe, and is injected into the right hind ankle joint of the rats in a 30° direction to the medial ankle joint, and the joint cavity on the opposite side is bulged to indicate the success of modeling. The normal control group of rats is injected with the same volume of sterile normal saline by the above method. After the modeling is successful, the treatment group starts to apply the drug locally, and the fur of the right hind limb of the rats is removed, and the drug is applied once in the morning and afternoon each day. The example 1-3 group, comparative example 1-10 group is respectively given the corresponding drug, and the dose is 1g crude drug / kg rat body weight. The drug solution is heated in a 38℃ water bath and then applied to the right ankle joint and the surrounding of the rats; the positive control group is given Voltaren, and the dose is 0.01g / kg rat body weight, and is applied to the right ankle joint and the surrounding of the rats. The continuous administration is 28d.

[0071] Determination of foot plantar swelling: three rats in each experimental group are randomly taken before modeling, 2 weeks after modeling, 1 week after administration, 2 weeks after administration, 3 weeks after administration, 4 weeks after administration, respectively, and the closed mark line is drawn on the bulged right hind ankle joint by using the oily marker pen. The diameter of the marked joint is measured by using the digital vernier caliper. The joint swelling rate is calculated according to the following formula:

[0072]

[0073] After the experiment, the rats are killed by inhaling excessive isoflurane. The right ankle joint is taken as the center, 1cm joint tissue is cut, the fur and muscle are carefully removed, and is placed in a test tube containing 1mL normal saline. The joint is broken and is placed in ice water for ultrasonic treatment for 15min, 3000r·min -1 centrifugation for 15min, and the supernatant is stored in a-20℃ refrigerator for subsequent detection. The content of IL-1β, IL-6 and TNF-α in the joint tissue is detected by using an ELISA kit.

[0074] The experimental results are shown in table 1 and table 2.

[0075] Table 1: the effect of joint swelling in rats

[0076]

[0077] Note: compared with the normal control group, ## P<0.01; compared with the model control group, the treatment group & P<0.05,&& P < 0.01.

[0078] According to the results in Table 1, after modeling for 2 weeks, the rats had obvious joint swelling, which was significantly different from that of the normal control group (P < 0.01); after administration, the swelling rate of the treatment group was significantly decreased compared with the model group, and the difference was statistically significant (P < 0.05) or significant (P < 0.01); compared with Example 1, the effects of the positive control group, Example 2-3 group were equivalent to that of Example 1, the effects of Comparative Examples 1-9 were worse than that of Example 1, and the difference was statistically significant (P < 0.05), and the effect of Comparative Example 10 was significantly worse than that of Example 1, and the difference was significant (P < 0.01). It is indicated that the traditional Chinese medicine composition of the present application can inhibit the joint swelling caused by gouty arthritis in rats, and the curative effect is better than that of the drugs of Comparative Examples 1-10.

[0079] Table 2: Effect on inflammatory factors of gouty arthritis rats

[0080]

[0081] Note: compared with the normal control group, **P < 0.01; compared with the model control group, the drug groups # P < 0.05, ## P < 0.01; compared with the Example 1 group, the drug groups & P < 0.05, && P < 0.01.

[0082] According to the results in Table 2, the contents of inflammatory factors IL-1β, IL-6 and TNF-α were significantly different between the model control group and the normal control group (P < 0.01). Compared with the model control group, the drugs of the positive control group, Examples 1-3 and Comparative Examples 1-10 had different degrees of positive regulation on the contents of IL-1β, IL-6 and TNF-α, and the difference was statistically significant (P < 0.05) or significant (P < 0.01); compared with the Example 1 group, the differences between Example 2, Example 3 and the positive control group and Example 1 group were not statistically significant, while the differences between Comparative Examples 1-9 and Example 1 group were statistically significant (P < 0.05), and the difference between Comparative Example 10 and Example 1 group was statistically significant (P < 0.05) or significant (P < 0.01). It is indicated that the raw material composition and the raw material ratio in the composition have an effect on the positive regulation of the contents of IL-1β, IL-6 and TNF-α, and the synergistic cooperation of each raw material composition and ratio in the composition of the present application can achieve the optimal effect.

[0083] Experimental Example 2:

[0084] Analgesic effect:

[0085] ICR mice, full female, body weight 18-22g, after adaptive feeding for 3 days, the hot plate pain threshold screening was carried out, and the mice with pain threshold between 5-20s were screened. The screening method was as follows: the mice were placed in the preheated hot plate pain tester at 55±0.5℃, and the latency of the mouse licking the hind foot reaction was used as the pain threshold index. The qualified mice were randomly divided into blank control group, positive control group, example 1-3 group, comparative example 1-10 group, 10 mice in each group. The blank control group was given distilled water 1g / kg of mouse body weight, the positive control group was given Voltaren 0.01g / kg of mouse body weight, and the example 1-3 group, comparative example 1-10 group was given corresponding drugs, the dose was 1g of crude drug / kg of mouse body weight. Each group of mice was given drug once a day, and the mouse double hind foot was smeared after the drug solution was heated in 38℃ water bath. It was continuous for 5 days.

[0086] The basic pain threshold of each group of mice was determined before administration, and the average pain threshold of each group was calculated. The pain threshold of mice was determined at 60min, 120min, 180min after the last administration. If the animal licking the hind foot reaction latency was prolonged to more than 30s under the analgesic effect, 30s was used as the upper limit of the licking foot latency to avoid long scalding of the skin.

[0087] The experimental results are shown in Table 3.

[0088] Table 3: Analgesic effect of traditional Chinese medicine composition

[0089]

[0090] Note: compared with the blank control group, # P<0.05, ## P<0.01; compared with example 1 group, each administration group & P<0.05, && P<0.01.

[0091] From the experimental results of Table 3, it can be seen that the administration of Voltaren can significantly prolong the pain threshold of mice at 60 min and 120 min, and the pain threshold is significantly higher than that of the blank control group (p<0.01), and at 180 min, Voltaren cannot prolong the pain threshold of mice, and the pain threshold has no significant difference compared with the blank control group; the traditional Chinese medicine composition of the inventive examples 1-3 and the comparative examples 1-10 can significantly prolong the pain threshold of mice at 60 min, 120 min and 180 min after administration, and the difference has statistical significance (P<0.05) or significant difference (P<0.01) compared with the blank control group; compared with the example 1 group, the pain-relieving effects of the examples 2-3 and the positive control drug are equivalent at 60 min and 120 min after administration, but the pain-relieving effect of the examples 1-3 is significantly better than that of the positive drug at 180 min after administration (P<0.01), and the pain-relieving effect of the comparative examples 1-10 is weaker than that of the example 1 at 60 min, 120 min and 180 min after administration (P<0.05 or P<0.01).

[0092] According to the experimental results, it can be seen that the traditional Chinese medicine composition has a certain analgesic effect, the effect is better than that of the comparative examples, and the analgesic time is longer than that of the positive control drug.

[0093] Clinical application examples:

[0094] Case 1: Wang, male, 51 years old, unemployed, due to eating too much seafood and irregular life, uric acid 516 µmol / L, total cholesterol 7.2, on May 6, 2022, suddenly ankle redness and pain, application of the liquid medicine of example 1, first use the electric hair dryer to expand the capillary, first apply the liquid medicine of example 1 on the knee joint and ankle joint of the leg, then apply it on the lumbar spine joint of the waist, and finally apply it on the shoulder and big vertebra. 1h, the redness and pain are relieved, and the patient can walk on the same day. After 1 month of treatment, once a day, the uric acid is reduced to the normal value of 164 µmol / L, and no recurrence is found.

[0095] Case 2: Zhao, female, 39 years old, business, due to long-term night work, beer and seafood, uric acid 537 µmol / L, total cholesterol 6.9, on July 3, 2023, suddenly metatarsal joint redness and pain, application of the liquid medicine of example 1, first use the electric hair dryer to expand the capillary, first apply the liquid medicine of example 1 on the knee joint and ankle joint of the leg, then apply it on the lumbar spine joint of the waist, and finally apply it on the shoulder and big vertebra. Forty minutes later, the swelling and pain were relieved, and the patient left by car after 1h. After 1 month of treatment, once a day, the uric acid is reduced to the normal value of 121 µmol / L, and no recurrence is found.

[0096] Finally, it should be noted that the above is only to illustrate the technical solutions of the present application, and is not a limitation on the scope of protection of the present application, and simple modifications or equivalent replacements of the technical solutions of the present application by those skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A Chinese medicine composition for external use for treating gout, swelling, pain and arthritis, the composition being prepared from the following raw materials by weight: 10-35 parts of Clematidis, 5-25 parts of Zanthoxylum bungeanum, 15-35 parts of Phellodendron amurense, 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; the composition being prepared by the following steps: (1) adding clematis root, lily chinensis, phellodendron amurense, lily scutellaria baicalensis, oriental bark, and part of panax notoginseng to ethanol and extracting by reflux to obtain an extract; (2) Grinding the remaining portion 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.

2. The external-use Chinese medicine composition according to claim 1, wherein The external Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-25 parts of clematis root, 5-15 parts of zanthoxylum bungeanum, 15-25 parts of phellodendron amurense, 5-20 parts of scutellaria baicalensis, 10-30 parts of oriental dwarfism, 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 external-use Chinese medicine composition according to claim 1, wherein The external Chinese medicine composition is prepared from the following raw materials by weight: 15 parts of clematis root, 10 parts of dianthus fragrans, 20 parts of phellodendron amurense, 15 parts of scutellaria baicalensis, 20 parts of oriental dwarfism root, 50 parts of panax notoginseng, 65 parts of gentiana macrophylla, 80 parts of notopterygium wilfordii and 50 parts of dried ginger.

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

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

6. The external-use Chinese medicine composition according to claim 1, wherein The weight ratio of the cortex phellodendri to the herb Lysimachia chinensis is 1-2:

1.

7. A method for preparing the external Chinese medicine composition according to any one of claims 1 to 6, comprising the following steps: (1) adding clematis root, lily chinensis, phellodendron amurense, lily scutellaria baicalensis, oriental bark, and part of panax notoginseng to ethanol and extracting by reflux to obtain an extract; (2) Grinding the remaining portion 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, wherein In the step (1), the volume fraction of ethanol in the ethanol aqueous solution is 60%-80%, and extraction is performed 2-3 times, with each extraction time being 1-2 hours.

9. The preparation method according to claim 7, wherein The pulverization in step (2) is to pulverize Panax notoginseng, Gentiana macrophylla, Notopterygium wilfordii and dried ginger into medium powder or fine powder.

10. A use of the external Chinese medicine composition according to any one of claims 1 to 6 or the external Chinese medicine composition prepared by the preparation method according to any one of claims 7 to 9 in preparing a drug for treating gout, swelling, pain and arthritis, the use comprising the following steps: first using an 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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