External traditional Chinese medicine composition capable of relieving gouty arthritis and preparation method of external traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to an external traditional Chinese medicine composition capable of relieving gouty arthritis and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 25 to 40 parts of sappan wood, 20 to 40 parts of flos carthami, 20 to 40 parts of radix et rhizoma rhei, 10 to 25 parts of cortex phellodendri, 10 to 25 parts of dragon's blood, 10 to 30 parts of radix angelicae, 10 to 20 parts of radix scrophulariae and 5 to 20 parts of borneol. Sappan wood, safflower, rhubarb, phellodendron, dragon's blood, dahurian angelica root, radix scrophulariae and borneol are combined according to a specific ratio to realize a synergistic effect, the formula is simple and strong in effect, the pain relieving effect on acute and chronic gouty arthritis is obvious, blood uric acid can be reduced in an auxiliary manner, and the traditional Chinese medicine composition has a good application prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a topical Chinese medicine composition that can relieve gouty arthritis and its preparation method. Background Technology

[0002] Gout is a clinical syndrome caused by the deposition of sodium urate or uric acid crystals in and around the joints, joint capsules, bursae, cartilage, and bone. It falls under the category of metabolic diseases. Clinical manifestations include severe joint pain, hyperuricemia, acute gouty arthritis, tophi deposition, tophaceous chronic arthritis, and joint deformities.

[0003] Acute gouty arthritis is the most common initial symptom of gout, clinically manifested as severe joint pain, redness, heat, swelling of surrounding tissues, and limited function. The condition is prone to recurrence, causing immense suffering for patients. Severe pain accounts for the largest proportion of gout patients seeking medical attention, making rapid pain relief a top priority. Without active prevention and treatment, gouty arthritis can easily lead to disability, deformity, and impaired joint function, drawing significant attention to the condition and making it a global focus in the medical field. Regardless of the final treatment method, quickly relieving pain is the primary element in treating this disease.

[0004] Currently, there is no cure for gouty arthritis. Western medicine primarily uses colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), and corticosteroids to relieve symptoms, but these medications have significant side effects, and long-term use can severely damage liver, kidney, and gastrointestinal function. Western medicine has yet to achieve a breakthrough in the treatment of gout. Traditional Chinese medicine (TCM), guided by syndrome differentiation and treatment principles, focuses on addressing the root cause of the disease, emphasizing strengthening the body's resistance and eliminating pathogenic factors, and treating both the symptoms and the underlying cause. This approach not only effectively controls acute symptoms and slows the onset of complications but also has fewer adverse reactions than Western medicine, is less expensive, and is more readily accepted by patients, allowing them to adhere to treatment.

[0005] Chinese invention patent application CN201910127102.2 discloses a topical composition for promoting blood circulation, removing blood stasis, dispelling wind, and reducing swelling, and its preparation method. The topical composition comprises the following components in parts by weight: 5-20 parts of Phellodendron bark; 5-50 parts of rhubarb; 5-30 parts of Aucklandia lappa; 5-20 parts of Akebia quinata; 5-30 parts of Angelica dahurica; 5-30 parts of Corydalis yanhusuo; 5-20 parts of Carthamus tinctorius; 5-40 parts of Spatholobus suberectus; and 5-30 parts of Caesalpinia sappan. The ingredients are: 5-40 parts of Ligusticum chuanxiong; 5-50 parts of Erythrina variegata bark; 5-30 parts of Achyranthes bidentata; 5-50 parts of Hibiscus mutabilis leaf; 5-20 parts of Notopterygium incisum; 5-40 parts of Saposhnikovia divaricata; 5-30 parts of Angelica pubescens; 5-30 parts of natural copper; 5-20 parts of processed wheat bran; 5-40 parts of Ephedra sinica; 5-30 parts of Asarum heterotropoides; 5-40 parts of Dragon's Blood; 5-45 parts of Drynaria fortunei; 5-50 parts of Angelica sinensis; and 5-50 parts of Panax notoginseng. This invention has the effects of promoting blood circulation, dispelling wind, reducing swelling and relieving pain.

[0006] Chinese invention patent application 202010015641.X discloses a pharmaceutical composition prepared from the following raw materials in the indicated weight ratios: 20-100 parts of Phellodendron bark, 10-30 parts of Corydalis rhizome, 5-25 parts of Angelica dahurica root, 3-15 parts of processed Arisaema heterophyllum, 10-30 parts of Aucklandia lappa root, 10-60 parts of Glauber's salt, 10-90 parts of rhubarb, 10-80 parts of dandelion, 10-25 parts of Paeonia suffruticosa root bark, 10-30 parts of peppermint, 10-100 parts of Trichosanthes kirilowii root, 5-30 parts of Hedyotis diffusa root, 5-30 parts of dragon's blood, 5-25 parts of Pseudobulbus Cremastrae spp., 5-40 parts of frankincense, 5-40 parts of myrrh, and 5-30 parts of aloe vera. This invention composition is used to treat gouty arthritis. While existing technologies have explored the use of traditional Chinese medicine (TCM) in the treatment of acute gouty arthritis, they generally suffer from complex formulations, and some contain toxic herbs such as Arisaema heterophyllum and Cremastra appendiculata. This not only reduces clinical applicability but may also lead to safety risks during long-term use (such as liver and kidney damage), ultimately affecting patient adherence to treatment. Summary of the Invention

[0007] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine external application composition that can relieve gouty arthritis and its preparation method. By refining the prescription, a precise formula with strict compatibility and synergistic effect is formed, which can significantly improve the therapeutic effect of rapid pain relief for gouty arthritis.

[0008] To achieve the above-mentioned objectives, the technical solution of this invention is as follows: A traditional Chinese medicine external application composition that can significantly relieve pain from gouty arthritis and improve uric acid levels includes the following raw materials by weight: 25-40 parts of sappanwood, 20-40 parts of safflower, 20-40 parts of rhubarb, 10-25 parts of phellodendron bark, 10-25 parts of dragon's blood, 10-30 parts of angelica dahurica, 10-20 parts of scrophularia ningpoensis, and 5-20 parts of borneol.

[0009] The medicinal properties of the ingredients in the prescription are as follows: Sappanwood is the dried heartwood of the sappan tree (Caesalpinia sappan), a legume, harvested in autumn and processed by removing the sapwood. It has the effects of promoting blood circulation, removing blood stasis, reducing swelling, and relieving pain, and is commonly used for traumatic injuries, dysmenorrhea, and carbuncles. Modern research shows that it has anti-inflammatory and antithrombotic effects, can improve blood viscosity in rats with blood stasis models, and has immunomodulatory effects.

[0010] Safflower is the dried flower of *Carthamus tinctorius*, a plant in the Asteraceae family. Its functions include promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain. It is mainly used to treat amenorrhea due to blood stasis and chest pain. Pharmacological studies show that it dilates coronary arteries and has anticoagulant properties; the yellow pigment in safflower also has antioxidant effects.

[0011] Rhubarb, derived from the rhizomes of plants such as Rheum palmatum in the Polygonaceae family, has the properties of purging, clearing heat, cooling the blood, and detoxifying. It is used for constipation due to excess heat and sores caused by heat toxins. Modern research has confirmed that its anthraquinone glycosides promote defecation, berberine has antibacterial properties, and it also protects the liver and promotes bile secretion.

[0012] Phellodendron bark is the bark of the Phellodendron chinense or Phellodendron amurense tree (Rutaceae family). It clears heat and dries dampness, drains fire and detoxifies, and treats damp-heat dysentery and fever due to yin deficiency. Berberine is its active ingredient, which has antibacterial, hypoglycemic, and immunomodulatory effects.

[0013] Dragon's blood is a processed resin product of the palm family, specifically the resin of the dragon's blood tree. It is used to promote blood circulation, relieve pain, astringe sores, and promote tissue regeneration. It is suitable for abdominal pain due to blood stasis and external bleeding. Its antithrombotic mechanism is related to the inhibition of platelet aggregation.

[0014] Angelica dahurica is the root of Angelica dahurica or Angelica sinensis of the Apiaceae family. It dispels wind and relieves pain, clears nasal passages, and is mainly used to treat headaches and nasal congestion. Its volatile oil components have anti-inflammatory and analgesic properties, and can inhibit skin fungi.

[0015] Scrophularia is the root of Scrophularia ningpoensis, belonging to the Scrophulariaceae family. It clears heat and cools the blood, nourishes yin and reduces fire, and is used for febrile diseases with rashes and yin deficiency with fire excess. Iridoids contain anti-inflammatory and immunomodulatory components, and also have cardiovascular protective effects.

[0016] Preferably, the raw materials, by weight, include the following: 25-35 parts of sappanwood, 25-35 parts of safflower, 25-35 parts of rhubarb, 10-20 parts of phellodendron bark, 10-20 parts of dragon's blood, 15-25 parts of angelica dahurica, 15-20 parts of scrophularia ningpoensis, and 5-15 parts of borneol.

[0017] Preferably, the ingredients, by weight, include the following: 30 parts of sappanwood, 30 parts of safflower, 30 parts of rhubarb, 15 parts of phellodendron bark, 15 parts of dragon's blood, 20 parts of angelica dahurica, 20 parts of scrophularia ningpoensis, and 10 parts of borneol.

[0018] Preferably, the mass ratio of sappanwood to scrophularia is 1-3:1.

[0019] Another object of the present invention is to provide a method for preparing the above-mentioned topical Chinese medicine composition, comprising the following steps: (1) Boil sappanwood, safflower, rhubarb, phellodendron bark, dragon's blood, angelica dahurica and scrophularia in water to obtain a decoction; (2) Let the decoction cool and add borneol.

[0020] Preferably, in step (1), the decocting is performed 1-3 times, and the decocting time for each time is 10-60 minutes.

[0021] Preferably, in step (1), the decocting is performed once and the decocting time is 20 minutes.

[0022] In embodiments of the present invention, the concentration of the decoction (crude drug / ml) obtained above is about 0.4-0.6 g crude drug / ml, preferably 0.45-0.55 g / ml, and most preferably 0.5 g / ml.

[0023] If the concentration of the decoction is too low after preparation, it can be appropriately concentrated to a concentration of 0.45-0.55g crude drug / ml.

[0024] In embodiments of the present invention, the clinical daily dosage of the decoction is 20 ml - 100 ml / day, preferably 30 ml - 60 ml / day. The specific dosage is adjusted according to the condition and the location and area of ​​pain. If the symptoms are mild and the area of ​​pain from gouty arthritis is small, the dosage should be small; if the condition is mild but there are many relapses, or if the symptoms are severe and the area of ​​pain from gouty arthritis is large, the daily dosage should be large.

[0025] Based on the amount of raw medicinal materials, the clinical daily dosage of the decoction of the present invention is 10 g - 50 g of raw medicinal materials / day, preferably 15 g - 30 g of raw medicinal materials / day.

[0026] A third objective of this invention is to provide a pharmaceutical preparation, wherein the raw materials of the pharmaceutical preparation include the aforementioned traditional Chinese medicine external application composition and pharmaceutically acceptable excipients.

[0027] Preferably, the dosage form of the pharmaceutical preparation is a topical preparation.

[0028] Another object of the present invention is to provide the use of the above-mentioned topical Chinese medicine composition or pharmaceutical preparation in the preparation of a medicine for the prevention or treatment of gouty arthritis.

[0029] Furthermore, the drug can significantly and rapidly relieve the pain of gouty arthritis.

[0030] Furthermore, the drug can help lower the body's uric acid levels.

[0031] After the medicine is prepared into a solution, it can be soaked in a towel or gauze and applied as a wet compress to the affected area. It can be soaked repeatedly, generally for 20-30 minutes per application, 2-3 times per day.

[0032] Furthermore, the pharmaceutical excipients used can be solid, liquid, or gaseous. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate, and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil, and water.

[0033] The medicaments of the present invention can be in forms suitable for topical use, such as lotions, creams, ointments, powders, or the like. Furthermore, the compositions can be in suitable forms for transdermal drug delivery devices. These formulations can be prepared using the traditional Chinese medicine compositions of the present invention through conventional processing methods. For example, a cream or ointment with a desired consistency can be prepared by mixing a hydrophilic material and water, and about 5 wt% to about 10 wt% of the compound.

[0034] In addition to the carrier components described above, the pharmaceutical formulations may include (if applicable) one or more additional carrier components, such as diluents, buffers, binders, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. Furthermore, components containing the traditional Chinese medicine composition of this invention can also be prepared in powder or concentrated form.

[0035] The drug of this invention may be prepared into an oral dosage form.

[0036] The beneficial effects of this invention are as follows: (1) The formula of this invention is as follows: Rhubarb and Phellodendron bark are the chief herbs for clearing heat, drying dampness and detoxifying; Sappanwood, Safflower and Dragon's Blood are the assistant herbs for promoting blood circulation, removing blood stasis, unblocking collaterals and relieving pain; Scrophularia helps to clear heat, cool blood and dissipate nodules and also helps to control dryness; Angelica dahurica helps to reduce swelling and relieve pain and promote penetration; Borneol is the guide herb to guide the medicines into the meridians and collaterals, directly reach the disease site and clear heat and relieve pain, thereby achieving a comprehensive therapeutic effect of clearing heat and removing dampness, dispersing blood stasis and unblocking collaterals, reducing swelling and relieving pain in the local area, which reflects the advantages of the external treatment method of traditional Chinese medicine of "local treatment and direct access to the disease site" and the wisdom of "simple formula and great effect".

[0037] (2) The present invention combines sappanwood, safflower, rhubarb, phellodendron bark, dragon's blood, angelica, scrophularia and borneol in a specific ratio to achieve synergistic effect. The formula is concise and effective, and has a significant therapeutic effect on gouty arthritis.

[0038] (3) The components of this invention are strictly proportioned and the preparation method is simple and easy to obtain. The composition obtained can not only prevent the onset of acute gout, but also quickly relieve joint pain and swelling caused by gout. It has obvious anti-inflammatory effects and can also help reduce blood uric acid. Compared with Western medicine, it has high safety, good patient compliance, and broad application prospects. Detailed Implementation

[0039] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0040] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention were obtained through conventional commercial means. Unless otherwise specified, all contents mentioned below are mass contents. Unless otherwise specified, it is understood that the process was carried out at room temperature.

[0041] Example 1 A topical Chinese medicine composition for rapidly relieving pain in gouty arthritis, the composition being made up of the following components in parts by weight: 30 parts of sappanwood, 30 parts of safflower, 30 parts of rhubarb, 15 parts of phellodendron bark, 15 parts of dragon's blood, 20 parts of angelica dahurica, 20 parts of scrophularia ningpoensis, and 10 parts of borneol.

[0042] The composition is prepared as follows: (1) Powder the following ingredients: sappanwood, safflower, rhubarb, phellodendron bark, dragon's blood, angelica dahurica, and scrophularia ningpoensis. Add 5 times the amount of water and bring to a boil over high heat. Then simmer over low heat for 20 minutes. Filter to obtain the decoction. (2) Cool the decoction to 40°C, adjust the concentration of the decoction to 0.50g raw herb / ml, add borneol and mix to obtain the final product.

[0043] Example 2 A topical Chinese medicine composition for rapidly relieving pain in gouty arthritis, the composition being made up of the following components in parts by weight: 25 parts of sappanwood, 20 parts of safflower, 20 parts of rhubarb, 10 parts of phellodendron bark, 10 parts of dragon's blood, 10 parts of angelica dahurica, 15 parts of scrophularia ningpoensis, and 5 parts of borneol.

[0044] The composition is prepared as follows: (1) Powder the following ingredients: sappanwood, safflower, rhubarb, phellodendron bark, dragon's blood, angelica dahurica, and scrophularia ningpoensis. Add 5 times the amount of water and bring to a boil over high heat. Then simmer over low heat for 20 minutes. Filter to obtain the decoction. (2) Cool the decoction to 40°C, adjust the concentration of the decoction to 0.50g raw herb / ml, add borneol and mix to obtain the final product.

[0045] Example 3 A topical Chinese medicine composition for rapidly relieving pain in gouty arthritis, the composition being made up of the following components in parts by weight: 40 parts of sappanwood, 40 parts of safflower, 40 parts of rhubarb, 20 parts of phellodendron bark, 20 parts of dragon's blood, 30 parts of angelica dahurica, 20 parts of scrophularia ningpoensis, and 20 parts of borneol.

[0046] The composition is prepared as follows: (1) Powder the sappanwood, safflower, rhubarb, phellodendron bark, dragon's blood, angelica dahurica and scrophularia, add 5 times the amount of water and decoct twice. The first decoction is 40 minutes and the second decoction is 20 minutes. Filter and combine the decoctions. (2) Cool the decoction to 40°C, adjust the concentration of the decoction to 0.55g raw herb / ml, add borneol and mix to obtain the final product.

[0047] Comparative Example 1 The difference between this comparative example and Example 1 is that the raw materials are different. The specific formula by weight is: 50 parts of sappanwood, 30 parts of safflower, 30 parts of rhubarb, 15 parts of phellodendron bark, 15 parts of dragon's blood, 20 parts of angelica dahurica, and 10 parts of borneol.

[0048] The composition is prepared as follows: (1) Powder the sappanwood, safflower, rhubarb, phellodendron bark, dragon's blood and angelica root, add 5 times the amount of water and bring to a boil over high heat, then simmer over low heat for 20 minutes, filter and obtain the decoction. (2) Cool the decoction to 40°C, adjust the concentration of the decoction to 0.50g raw herb / ml, add borneol and mix to obtain the final product.

[0049] Comparative Example 2 The difference between this comparative example and Example 1 is that the raw materials are different. The specific formula by weight is: 50 parts of Scrophularia ningpoensis, 30 parts of Carthamus tinctorius, 30 parts of Rheum palmatum, 15 parts of Phellodendron chinense, 15 parts of Dragon's Blood, 20 parts of Angelica dahurica, and 10 parts of Borneol.

[0050] The composition is prepared as follows: (1) Crush Scrophularia, Carthamus tinctorius, Rheum palmatum, Phellodendron chinense, Dragon's Blood, and Angelica dahurica into powder, add 5 times the amount of water, bring to a boil over high heat, then simmer over low heat for 20 minutes, filter, and obtain the decoction. (2) Cool the decoction to 40°C, adjust the concentration of the decoction to 0.50g raw herb / ml, add borneol and mix to obtain the final product.

[0051] Comparative Example 3 The difference between this comparative example and Example 1 is that the proportions are different. The raw materials of the composition are composed of the following components in parts by mass: 20 parts of sappanwood, 30 parts of safflower, 30 parts of rhubarb, 15 parts of phellodendron bark, 15 parts of dragon's blood, 20 parts of angelica dahurica, 30 parts of scrophularia ningpoensis, and 10 parts of borneol.

[0052] The composition is prepared as follows: (1) Powder the following ingredients: sappanwood, safflower, rhubarb, phellodendron bark, dragon's blood, angelica dahurica, and scrophularia ningpoensis. Add 5 times the amount of water and bring to a boil over high heat. Then simmer over low heat for 20 minutes. Filter to obtain the decoction. (2) Cool the decoction to 40°C, adjust the concentration of the decoction to 0.50g raw herb / ml, add borneol and mix to obtain the final product.

[0053] Comparative Example 4 The difference between this comparative example and Example 1 is that the raw materials are different. Specifically, safflower is replaced with chuanxiong, which has similar effects, and scrophularia is replaced with moutan bark, which has similar effects. The raw materials of the composition are composed of the following components in parts by weight: 30 parts of sappanwood, 30 parts of chuanxiong, 30 parts of rhubarb, 15 parts of phellodendron bark, 15 parts of dragon's blood, 20 parts of angelica dahurica, 20 parts of moutan bark, and 10 parts of borneol.

[0054] The composition is prepared as follows: (1) Powder the following ingredients: Sappanwood, Ligusticum chuanxiong, rhubarb, Phellodendron bark, dragon's blood, Angelica dahurica, and Moutan bark. Add 5 times the amount of water and bring to a boil over high heat. Then simmer over low heat for 20 minutes. Filter to obtain the decoction. (2) Cool the decoction to 40°C, adjust the concentration of the decoction to 0.50g raw herb / ml, add borneol and mix to obtain the final product.

[0055] I. Drug Efficacy Experiment 1.1 Experimental Methods Preparation of the modeling agent: Weigh 800 mg of sodium urate and dissolve it in 5 mL of 1 mol / L NaOH solution. Add 155 mL of sterile 0.5% sodium chloride solution, heat and stir until completely dissolved, and allow to cool naturally. Adjust the pH to 7.2 with 1 mol / L HCl and leave at room temperature overnight. The next day, centrifuge to collect the precipitate, dry at 70°C, and collect the sodium monourate crystals (MSU) for storage at 4°C. Preparation of sodium urate solution: Weigh 1250 mg of sodium monourate crystals and prepare a 25 mg / mL sodium monourate suspension using physiological saline.

[0056] Preparation of 3% potassium oxonate: Weigh 3g of potassium oxonate and dissolve it in 97mL of physiological saline hot water.

[0057] Animal grouping: Eighty male SD rats, weighing 200±20g, were randomly selected. Seventy-two rats were randomly divided into nine groups of eight each: model group, positive group, groups for Examples 1-3, and control groups for Examples 1-4. The remaining eight rats served as the normal control group. The normal control group received an intraperitoneal injection of an equal volume of physiological saline, while the other groups received an intraperitoneal injection of 1 mL / 100 g of 3% potassium oxonate solution twice a day for one week to establish a rat model of hyperuricemia. The day after successful model establishment, drug administration began. The model group and the normal group received the same volume of ultrapure water. For groups in Examples 1-3 and Comparative Examples 1-4, a small square towel soaked in the corresponding prepared drug solution was applied topically to the right ankle joint. Each rat used 5 ml of the decoction (approximately 2.5 g of raw drug, equivalent to 6 times the clinical dose) daily, repeatedly applying it to the right ankle joint up to 0.5 cm above the ankle, twice a day (morning and afternoon). The positive group was administered colchicine 0.6 mg / kg / day by gavage. On the 4th day of administration, in addition to the normal group, rats in other groups had 0.2 mL of 25 mg / mL sodium urate solution injected into the ankle joint cavity at a 45° angle to the medial side of the tibialis tendon, with the needle tip reaching the periosteum, to establish a rat model of gouty arthritis. Drug administration continued for 3 days after joint model establishment.

[0058] The joint thickness at the point of maximum swelling was measured using a micrometer. The joint thickness of the right hindfoot ankle before modeling and after the last administration was recorded, and two decimal places were retained. The joint swelling rate was calculated as %. Wherein, the joint swelling rate % = (average joint thickness after the last administration - average joint thickness before modeling) * 100% / average joint thickness before modeling.

[0059] Uric acid levels in the serum of rats in each group were measured by blood collection from anesthetized eyeballs. The concentrations of Il-1β and TNF-α inflammatory factors in the serum were detected using an enzyme-linked immunosorbent assay (ELISA) kit.

[0060] 1.2 Statistics and Analysis Data were processed using statistical software. Analysis of variance and LSD-t test were used for comparisons between groups. P < 0.05 was considered statistically significant. Results are shown in Tables 1 and 2.

[0061] Table 1. Therapeutic effects of the composition on arthritis in rats.

[0062] Note: Compared with the normal group, *P<0.05, **P<0.01; compared with the model group, #P<0.05, ##P<0.01; compared with Example 1 group, &P<0.05, &&P<0.01.

[0063] Table 2 Results of the decoction improving serum uric acid and inflammatory factor levels

[0064] Note: Compared with the normal group, **P<0.01; compared with the model group, #P<0.05, ##P<0.01; compared with Example 1 group, &P<0.05, &&P<0.01.

[0065] The composition of this invention exerts a comprehensive therapeutic effect locally, clearing heat and dampness, dispersing blood stasis and unblocking meridians, reducing swelling and relieving pain. It can be used to treat acute gouty arthritis, significantly alleviating its pain and swelling symptoms. When used correctly under professional guidance, it shows potential as an alternative to colchicine in the treatment of acute gouty arthritis, potentially reducing the risk of side effects associated with colchicine and other Western medicines. The development of this combination drug reflects the characteristics of holistic regulation and multi-target intervention in traditional Chinese medicine.

[0066] II. Clinical Case Collection 1. Mr. Wang, male, 43 years old, presented on April 17, 2025, with a history of recurrent severe pain and swelling in his right big toe joint for over a year, which had worsened over the past week. He was clinically diagnosed with gouty arthritis. Pre-treatment laboratory tests showed that his serum uric acid (UA) was 472 μmol / L, the inflammatory factor IL-1β level was 81 pg / ml, and the TNF-α level was 63 pg / ml, all higher than the normal range. After two weeks of external application of the herbal composition of this invention, a follow-up examination showed significant relief of the swelling and pain in his right big toe. Test results showed that serum uric acid had decreased to 418 μmol / L, IL-1β to 45 pg / ml, and TNF-α to 32 pg / ml. His VAS score decreased from 8.3 to 3.0. No adverse skin reactions were observed during treatment. The data confirms that the external application treatment not only effectively reduced serum uric acid concentration but also inhibited the expression of key inflammatory factors, resulting in comprehensive improvement in clinical indicators related to gouty arthritis.

[0067] 2. Mr. Zhang, male, 35 years old, presented on May 10, 2025, complaining of swelling and discomfort on the medial side of his left forefoot for 3 days, with pain worsening during activity. He was clinically diagnosed with an acute exacerbation of gouty arthritis. Pre-treatment tests showed a serum uric acid (UA) level of 520 μmol / L, inflammatory factor IL-1β reaching 95 pg / ml, and TNF-α 78 pg / ml, indicating severe metabolic disorder and inflammatory activation. The patient applied the herbal composition of this invention topically to the affected area daily. After one week of treatment, a follow-up examination (May 17, 2025) showed significant relief of symptoms in the left foot. Follow-up results showed that serum uric acid had decreased to 406 μmol / L, IL-1β had significantly decreased to 44 pg / ml, and TNF-α had decreased to 34 pg / ml. No adverse skin reactions were observed during treatment. The patient reported significant relief of local pain, significant improvement in walking function, and a VAS score decrease from 8.1 to 3.2. This external treatment method has been shown to have a regulatory effect on both the metabolic and inflammatory pathways of acute gouty arthritis.

[0068] 3. Ms. Liu, female, 47 years old, presented on May 15, 2025, complaining of recurrent pain and swelling in her left ankle and right knee joints for over two years, diagnosed with gouty arthritis (chronic active phase). Pre-treatment test results: serum uric acid (UA) 508 μmol / L, IL-1β 69 pg / ml, TNF-α 47 pg / ml. She received topical application of the herbal composition of this invention twice daily for three weeks. A follow-up examination on June 5, 2025, showed: serum uric acid (UA) 463 μmol / L, IL-1β 51 pg / ml, TNF-α 36 pg / ml. Her VAS score decreased from 6.2 to 2.7. The patient's joint redness and swelling subsided, mobility limitations significantly improved, and gout and inflammatory markers improved. No adverse skin reactions were observed during treatment.

[0069] 4. Mr. Zhao, male, 51 years old, presented on June 22, 2025, with a 2-year history of recurrent severe swelling and pain in his right ankle, and an acute attack over the past 4 days. Pre-treatment tests showed: serum uric acid (UA) 538 μmol / L, IL-1β 88 pg / ml, and TNF-α 71 pg / ml. He was treated with topical application of the herbal composition of this invention three times daily. After 10 days of treatment (July 2, 2025), a follow-up examination showed significant reduction in joint redness and swelling, serum uric acid decreased to 458 μmol / L, IL-1β to 49 pg / ml, and TNF-α to 38 pg / ml. His walking function recovered, and his VAS pain score decreased from 8 to 2. No adverse skin reactions were observed during treatment.

[0070] 5. Ms. Sun, female, 58 years old, presented on May 30, 2025, with a history of alternating swelling and pain in the first metatarsophalangeal joints of both feet for over 3 years, which had worsened over the past half month. Laboratory tests showed: serum uric acid (UA) 503 μmol / L, IL-1β 74 pg / ml, TNF-α 52 pg / ml. After 16 days of continuous topical application of the herbal composition of this invention (until June 15, 2025), a follow-up visit revealed: tenderness in both foot joints had disappeared; serum uric acid was 426 μmol / L; IL-1β was 48 pg / ml; TNF-α was 33 pg / ml; the patient could walk normally with shoes; her VAS pain score decreased from 7.2 to 1.5; and the frequency of attacks decreased from twice a month to no recurrence for 3 months. No adverse skin reactions were observed during treatment.

[0071] 6. Mr. Wu, male, 34 years old, presented to the emergency room on July 5, 2025, with a sudden onset of redness, swelling, heat, and pain in his left wrist joint for 36 hours. Tests showed: serum uric acid (UA) 622 μmol / L (significantly elevated in the acute phase), IL-1β 102 pg / ml, and TNF-α 89 pg / ml. After 5 days of intensive external application of the herbal composition of this invention (every 4 hours) (July 10, 2025): the redness and swelling of the left wrist significantly subsided, serum uric acid rapidly decreased to 487 μmol / L, IL-1β 57 pg / ml, TNF-α 41 pg / ml, and the VAS pain score decreased from 7.5 to 3.0. The patient's joint mobility returned to normal. No adverse skin reactions were observed during the treatment.

[0072] 7. Ms. Zheng, female, 48 years old, presented on April 10, 2025, with a 1.5-year history of recurrent effusion and pain in her right knee joint. Pre-treatment data: serum uric acid (UA) 489 μmol / L, IL-1β 68 pg / ml, TNF-α 46 pg / ml; joint ultrasound showed synovial thickening. After 3 weeks of topical application twice daily (until May 1, 2025), the knee joint effusion was absorbed, serum uric acid decreased to 421 μmol / L, IL-1β to 43 pg / ml, TNF-α to 29 pg / ml, and the VAS pain score decreased from 6.7 to 2.6. The patient's ability to climb stairs significantly improved. No adverse skin reactions were observed during treatment.

[0073] 8. Mr. Feng, male, 63 years old, presented on June 18, 2025, with a 3-year history of gouty tophi in multiple joints (bilateral ankles and right elbow). Pre-treatment tests showed: serum uric acid (UA) 578 μmol / L, IL-1β 83 pg / ml, and TNF-α 66 pg / ml. After 4 weeks of external application of the herbal composition of this invention (July 16, 2025), a follow-up examination revealed: he reported relief of joint pain; serum uric acid 462 μmol / L; IL-1β 51 pg / ml; TNF-α 37 pg / ml; and his VAS pain score decreased from 6.5 to 2.8. The patient's joint function showed significant improvement. No adverse skin reactions were observed during treatment.

[0074] 9. Mr. Chen, male, 39 years old, presented to the emergency department on June 3, 2025, with a sudden onset of redness, swelling, heat, and pain in his left dorsum of the foot for 48 hours. Laboratory tests showed: serum uric acid (UA) 602 μmol / L, IL-1β 98 pg / ml, and TNF-α 84 pg / ml. After 4 days of treatment with the topical application of the herbal composition of this invention (once every 6 hours), a follow-up visit was conducted on June 7, 2025: the redness and swelling had significantly subsided, serum uric acid had rapidly decreased to 467 μmol / L, IL-1β 53 pg / ml, TNF-α 39 pg / ml, and the VAS pain score had decreased from 7.8 to 2.5. No adverse skin reactions were observed during the treatment period.

[0075] 10. Ms. Li, female, 52 years old, presented on May 12, 2025, with a 2-year history of recurrent swelling and pain in her right heel. Pre-treatment data: serum uric acid (UA) 493 μmol / L, IL-1β 71 pg / ml, TNF-α 49 pg / ml. After 2 weeks of daily topical treatment (May 26, 2025): serum uric acid decreased to 427 μmol / L, IL-1β 46 pg / ml, TNF-α 31 pg / ml, VAS score decreased from 6.8 to 2.1, and joint mobility recovered. No adverse skin reactions were observed during treatment.

[0076] 11. Mr. Zhou, male, 45 years old, presented on April 25, 2025, with acute swelling and pain in his right knee joint for 3 days. Tests showed UA 583 μmol / L, IL-1β 91 pg / ml, and TNF-α 76 pg / ml. After 5 days of intensive topical treatment (4 times daily) (April 30, 2025): serum uric acid decreased to 472 μmol / L, IL-1β 50 pg / ml, TNF-α 35 pg / ml, and VAS score decreased from 8.2 to 2.9. No adverse skin reactions were observed during treatment.

[0077] 12. Ms. Huang, female, 61 years old, presented on July 8, 2025, with chronic swelling and pain in both ankles accompanied by tophi formation. Before treatment: UA 562 μmol / L, IL-1β 80 pg / ml, TNF-α 64 pg / ml. After 3 weeks of continuous topical treatment (July 29, 2025): serum uric acid decreased to 444 μmol / L, IL-1β 47 pg / ml, TNF-α 33 pg / ml, tophi softened and shrank, and the VAS score decreased from 5.9 to 2.4. No adverse skin reactions were observed during treatment.

[0078] 13. Mr. Zhu, male, 50 years old, presented with an acute attack of fever in his left big toe on June 10, 2025. Tests showed UA 642 μmol / L, IL-1β 108 pg / ml, and TNF-α 92 pg / ml. After 3 days of topical application every 4 hours, the inflammation subsided. A follow-up examination on June 17, 2025 (7 days after treatment) showed: UA 481 μmol / L, IL-1β 55 pg / ml, TNF-α 37 pg / ml, and the VAS score decreased from 8.6 to 3.1. No adverse skin reactions were observed during treatment.

[0079] 14. Ms. Xu, female, 44 years old, presented on May 5, 2025, with a 1.5-year history of recurrent swelling and pain in the right middle finger joint. Before treatment, her levels were: UA 476 μmol / L, IL-1β 66 pg / ml, and TNF-α 45 pg / ml. After 12 days of topical treatment twice daily (until May 17, 2025): UA decreased to 415 μmol / L, IL-1β to 41 pg / ml, TNF-α to 28 pg / ml, and her VAS score decreased from 6.5 to 1.8. No adverse skin reactions were observed during treatment.

[0080] 15. Mr. Lin, male, 56 years old, presented on July 12, 2025, with an acute attack of gout in his left forefoot. Tests showed UA 591 μmol / L, IL-1β 94 pg / ml, and TNF-α 81 pg / ml. After 6 days of topical treatment (July 18, 2025): UA decreased to 455 μmol / L, IL-1β to 52 pg / ml, TNF-α to 36 pg / ml, and the VAS score decreased from 7.7 to 2.7. No adverse skin reactions were observed during treatment.

[0081] 16. Ms. Ma, female, 53 years old, presented with chronic metatarsal pain and morning stiffness in both feet on April 15, 2025. Before treatment, her levels were: UA 512 μmol / L, IL-1β 73 pg / ml, and TNF-α 51 pg / ml. After 18 days of topical treatment (until May 3, 2025): UA decreased to 431 μmol / L, IL-1β to 45 pg / ml, TNF-α to 30 pg / ml, and her VAS score decreased from 7.1 to 1.9. No adverse skin reactions were observed during treatment.

[0082] 17. Mr. Hu, male, 48 years old, presented with acute redness and swelling of the right ankle joint for 3 days on June 28, 2025. Laboratory tests showed UA 568 μmol / L, IL-1β 87 pg / ml, and TNF-α 72 pg / ml. After 4 days of intensive topical treatment, the redness and swelling subsided. A follow-up examination on July 7, 2025 (9 days after treatment) showed: UA 449 μmol / L, IL-1β 49 pg / ml, TNF-α 34 pg / ml, and VAS score decreased from 7.9 to 2.3. No adverse skin reactions were observed during treatment.

[0083] 18. Ms. Gao, female, 60 years old, presented on May 21, 2025, with chronic gouty arthritis in both knees. Before treatment, her UA level was 497 μmol / L, IL-1β was 69 pg / ml, and TNF-α was 50 pg / ml. After 3 weeks of continuous topical application (June 11, 2025): UA decreased to 422 μmol / L, IL-1β to 42 pg / ml, TNF-α to 29 pg / ml, and her VAS score decreased from 6.6 to 1.7. No adverse skin reactions were observed during treatment.

[0084] 19. Mr. Luo, male, 41 years old, presented with sudden onset of severe pain in his left little toe on July 14, 2025. Tests showed UA 612 μmol / L, IL-1β 101 pg / ml, and TNF-α 86 pg / ml. After four days of topical treatment every 5 hours (July 18, 2025): UA decreased to 470 μmol / L, IL-1β to 58 pg / ml, TNF-α to 40 pg / ml, and the VAS score decreased from 7.4 to 2.8. No adverse skin reactions were observed during treatment.

[0085] 20. Ms. Cai, female, 57 years old, presented with recurrent swelling and pain in her right wrist joint accompanied by functional impairment for 2 years as of June 5, 2025. Before treatment, her UA level was 487 μmol / L, IL-1β was 70 pg / ml, and TNF-α was 48 pg / ml. After 14 days of topical treatment (June 19, 2025): UA decreased to 416 μmol / L, IL-1β to 44 pg / ml, and TNF-α to 31 pg / ml; joint mobility significantly improved; and her VAS score decreased from 6.3 to 1.6. No adverse skin reactions were observed during treatment.

[0086] The above cases were treated according to clinical syndrome differentiation and treatment principles in Example 1, Example 2, or Example 3 of the external application of the traditional Chinese medicine composition of this invention. The external application of this traditional Chinese medicine composition demonstrated a comprehensive and consistent therapeutic trend. All patients had significant hyperuricemia (serum uric acid range 476-642 μmol / L) and abnormally elevated inflammatory factors (IL-1β 66-108 pg / ml, TNF-α 45-92 pg / ml) before treatment, consistent with the pathological characteristics of acute gout attacks or chronic active gout. Treatment dosage: 30-60 ml of decoction per day. The specific dosage is adjusted according to the condition; for milder symptoms and smaller areas of gouty arthritis pain, a smaller dosage is appropriate; for mild cases with frequent relapses or severe symptoms and larger areas of gouty arthritis pain, a larger daily dosage is required. Key indicators showed regular improvement after treatment: serum uric acid levels generally decreased by 70-155 μmol / L (a decrease of 15%-25%), and IL-1β and TNF-α decreased by 40%-55% and 45%-60%, respectively. In terms of symptom relief, the VAS pain score decreased by an average of 5.1 points (from 6.3-8.6 points to 1.6-3.2 points), accompanied by the reduction of joint redness and swelling and the recovery of mobility. Among them, the frequency of attacks in Sun (Case 5) was significantly reduced, and the tophi in Huang (Case 12) and Feng (Case 8) softened and shrank, suggesting that it also has an intervention effect on chronic lesions.

[0087] The treatment regimen is flexible and adaptable to different clinical scenarios: patients with acute exacerbations (such as Wu and Chen) receive high-frequency topical application (every 4-6 hours), achieving rapid anti-inflammatory and analgesic effects within 5 days; chronic patients achieve steady improvement through continuous treatment 2-3 times daily (14-28 days). Notably, all cases clearly recorded "no adverse skin reactions," confirming the good local safety of this topical treatment. Typical cases include Zhu (Case 13) with acute severe fever and Zheng (Case 7) with joint effusion, both showing synergistic improvement with simple topical application. This further suggests that this therapy may achieve universal therapeutic value for different stages and clinical manifestations of gouty arthritis by inhibiting core inflammatory pathways such as IL-1β / TNF-α and simultaneously regulating uric acid metabolism and inflammatory responses.

[0088] Based on the limited case data observation and analysis in this group, the topical application of the herbal composition showed a certain positive trend in relieving patients' pain, reducing blood uric acid levels, and inhibiting the expression of key inflammatory factors. At the same time, these preliminary results suggest that this approach may have potential clinical value in symptom control during the acute phase, disease management during the chronic phase, and improvement of some complications.

[0089] This article uses specific examples to illustrate the inventive concept in detail. The description of the above embodiments is only for the purpose of helping to understand the core idea of ​​the present invention. It should be noted that any obvious modifications, equivalent substitutions or other improvements made by those skilled in the art without departing from the inventive concept should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine external application composition capable of relieving gouty arthritis, characterized in that, The raw materials, by weight, include the following: 25-40 parts of sappanwood, 20-40 parts of safflower, 20-40 parts of rhubarb, 10-25 parts of phellodendron bark, 10-25 parts of dragon's blood, 10-30 parts of angelica dahurica, 10-20 parts of scrophularia ningpoensis, and 5-20 parts of borneol.

2. The traditional Chinese medicine external application composition according to claim 1, characterized in that, The raw materials, by weight, include the following: 25-35 parts of sappanwood, 25-35 parts of safflower, 25-35 parts of rhubarb, 10-20 parts of phellodendron bark, 10-20 parts of dragon's blood, 15-25 parts of angelica dahurica, 15-20 parts of scrophularia ningpoensis, and 5-15 parts of borneol.

3. The traditional Chinese medicine external application composition according to claim 1, characterized in that, The ingredients, by weight, include the following: 30 parts sappanwood, 30 parts safflower, 30 parts rhubarb, 15 parts phellodendron bark, 15 parts dragon's blood, 20 parts angelica dahurica, 20 parts scrophularia ningpoensis, and 10 parts borneol.

4. The traditional Chinese medicine external application composition according to claim 1, characterized in that, The mass ratio of sappanwood to scrophularia is 1-3:

1.

5. The method for preparing the traditional Chinese medicine external application composition according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Boil sappanwood, safflower, rhubarb, phellodendron bark, dragon's blood, angelica dahurica and scrophularia in water to obtain a decoction; (2) Let the decoction cool and add borneol.

6. The preparation method according to claim 5, characterized in that, In step (1), the decocting is performed 1-3 times, and each decocting takes 10-60 minutes.

7. The preparation method according to claim 5, characterized in that, In step (1), the decocting is performed once, and the decocting time is 20 minutes.

8. A pharmaceutical preparation, characterized in that, The raw materials of the pharmaceutical preparation include the traditional Chinese medicine external application composition as described in any one of claims 1-4 and pharmaceutically acceptable excipients.

9. The pharmaceutical preparation according to claim 8, characterized in that, The dosage form of the pharmaceutical preparation is a topical preparation.

10. The use of the traditional Chinese medicine external application composition according to any one of claims 1-4, or the pharmaceutical preparation according to claim 8 or 9, in the preparation of a medicament for the prevention or treatment of gouty arthritis.

Images