External traditional Chinese medicine ointment for treating acute gouty arthritis and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to an external traditional Chinese medicine ointment for treating acute gouty arthritis and a preparation method thereof. Comprising the following components in parts by mass: 18-22 parts of rheum officinale, 20-26 parts of turmeric, 15-19 parts of cortex phellodendri, 15-19 parts of indigo naturalis, 15-19 parts of rhizoma smilacis glabrae, 14-18 parts of radix clematidis, 14-18 parts of moutan bark, 14-18 parts of herba lycopi, 10-14 parts of semen plantaginis, 8-12 parts of radix stephaniae tetrandrae, 8-12 parts of rhizoma corydalis and 5-9 parts of liquorice. The ointment not only aims at inflammation and pain in the acute stage of gout, but also promotes uric acid excretion through medicines such as rhizoma smilacis glabrae and semen plantaginis, and has a certain auxiliary uric acid reduction effect. The compound design of the traditional Chinese medicine composition integrates the functions of clearing heat and promoting diuresis and promoting blood circulation to remove blood stasis, body metabolism is regulated from multiple targets, symptoms are relieved, pathogenesis conditioning is also considered, and a more comprehensive solution is provided for treatment of gouty arthritis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and in particular to a topical traditional Chinese medicine ointment for treating acute gouty arthritis and its preparation method. Background Technology

[0002] Acute gouty arthritis is an inflammatory reaction caused by elevated blood uric acid levels due to purine metabolism disorders, leading to the deposition of urate crystals in the joints and surrounding tissues. Clinically, it manifests as sudden redness, swelling, severe pain, and limited mobility in the joints. Current Western medicine treatments primarily involve nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and glucocorticoids; however, long-term use can easily cause adverse reactions such as gastrointestinal damage, liver and kidney toxicity. Therefore, developing safe and effective topical traditional Chinese medicine preparations to relieve symptoms through local administration and reduce systemic side effects is of significant clinical importance.

[0003] Traditional Chinese medicine considers gout to fall under the category of "Bi syndrome," often caused by damp-heat obstructing the meridians. Treatment focuses on clearing heat and dampness, and promoting blood circulation to remove blood stasis. Currently available topical Chinese medicine ointments often combine heat-clearing and detoxifying herbs such as rhubarb and phellodendron bark with blood-activating and pain-relieving herbs; however, they generally suffer from low transdermal absorption and slow action. While some compound preparations have certain therapeutic effects, inappropriate matrix selection or crude extraction processes lead to unstable drug release, affecting clinical efficacy.

[0004] In recent years, with the development of transdermal drug delivery technology, the optimization of topical Chinese medicine preparations has become a research hotspot. Improving the solubility and skin permeability of drug components through scientific formulation and process improvement is key to enhancing the efficacy of topical ointments. Furthermore, existing technologies rarely address the targeted inhibition of inflammatory factors in the acute phase of gout, necessitating the development of a topical Chinese medicine ointment that combines anti-inflammatory and analgesic properties with the promotion of uric acid excretion to meet clinical needs. Summary of the Invention

[0005] The purpose of this invention is to provide a topical Chinese medicine ointment for treating acute gouty arthritis and its preparation method.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a topical Chinese medicine ointment for treating acute gouty arthritis, comprising the following components in parts by weight: rhubarb 18-22 parts, turmeric 20-26 parts, phellodendron bark 15-19 parts, indigo naturalis 15-19 parts, smilax glabra 15-19 parts, clematis chinensis 14-18 parts, peony bark 14-18 parts, lycopus lucidus 14-18 parts, plantain seed 10-14 parts, fangji 8-12 parts, corydalis yanhusuo 8-12 parts, and licorice 5-9 parts.

[0007] This invention also provides a method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis, comprising the following steps: (1) Rhubarb, Phellodendron bark, Smilax glabra, Clematis chinensis, Lycopus lucidus, Plantago asiatica, Stephania tetrandra, and Glycyrrhiza uralensis are mixed to obtain material 1; (2) Mix the material 1 with water, boil, filter, and obtain filtrate; (3) The filtrate is concentrated to obtain a clear extract; (4) Mix turmeric, peony bark, and corydalis to obtain material 2; (5) Extract the material 2 by reflux with ethanol to obtain an alcohol extract, and then concentrate the extract after recovering the ethanol. (6) Grind the indigo to obtain indigo powder; (7) Mix the clear paste obtained in step (3), the extract obtained in step (5), the indigo powder obtained in step (6), and the matrix.

[0008] Preferably, in step (2), the mass ratio of material 1 to water is 1:3~5; and the decocting time is 100~160min.

[0009] Preferably, step (3) is concentrated to a clear paste with a relative density of 1.12~1.18 at 60°C.

[0010] Preferably, the volume concentration of ethanol in step (5) is 62-68%.

[0011] Preferably, the ratio of material 2 to ethanol in step (5) is 1g:6~10ml.

[0012] Preferably, the reflux extraction time in step (5) is 70-100 min, and the number of extractions is 2-3.

[0013] Preferably, the particle size of the indigo powder in step (6) is 80~120 mesh.

[0014] Preferably, the addition ratio of the matrix in step (7) is 2 to 4 times the mass of the extract, extract, and indigo powder.

[0015] Preferably, the matrix is ​​coconut oil and beeswax in a mass ratio of 3 to 5:1.

[0016] Compared with the prior art, the present invention has the following beneficial effects: This invention uses rhubarb and turmeric as the principal herbs. Rhubarb clears heat, removes blood stasis, and unblocks meridians, while turmeric breaks up blood stasis, promotes qi circulation, and relieves pain. Together, they exert the core therapeutic effects of clearing heat, removing blood stasis, reducing swelling, and relieving pain. Phellodendron bark and indigo naturalis are the assistant herbs. Phellodendron bark clears heat and dries dampness, while indigo naturalis cools the blood and detoxifies. Together, they assist the principal herbs in enhancing their heat-clearing and detoxifying effects, providing a powerful intervention against the damp-heat stagnation pathogenesis in the acute phase of gout.

[0017] Smilax glabra, Clematis chinensis, Paeonia suffruticosa, and Lycopus lucidus serve as adjuvant herbs, targeting the four major pathological factors of dampness, wind, heat, and blood stasis, respectively. Smilax glabra and Plantago asiatica promote uric acid excretion by eliminating dampness and turbidity, while Clematis chinensis and Paeonia suffruticosa dispel wind and invigorate blood circulation to enhance the analgesic effect. Stephania tetrandra and Corydalis yanhusuo assist the adjuvant herbs in clearing the channels and relieving pain. Glycyrrhiza uralensis serves as the guiding herb, harmonizing the other herbs and mitigating the bitter and cold properties of rhubarb and other herbs, preventing damage to the body's vital energy and ensuring a balanced approach of warming and cooling properties, as well as a combination of tonifying and purging effects.

[0018] The external herbal ointment provided by this invention utilizes a scientifically formulated combination of rhubarb, turmeric, and phellodendron bark to fully exert its effects of clearing heat and dampness, promoting blood circulation and removing blood stasis. It can effectively relieve joint redness, swelling, and severe pain caused by acute gouty arthritis. Clinical data show that patients' pain scores significantly decreased after using this ointment, comparable to the effect of oral celecoxib. Simultaneously, white blood cell count and inflammatory markers decreased significantly, indicating its excellent anti-inflammatory effect and rapid improvement of acute symptoms.

[0019] Compared to Western medicine treatments, this traditional Chinese medicine ointment uses all-natural ingredients and is applied directly to the affected area through topical administration, avoiding systemic side effects such as gastrointestinal damage and liver and kidney toxicity that may be caused by oral nonsteroidal anti-inflammatory drugs or glucocorticoids. Its base is made of coconut oil and beeswax, which have good skin affinity and permeability, promoting drug absorption without irritating the skin, making it suitable for long-term use.

[0020] This ointment not only targets the inflammation and pain of acute gout, but also promotes uric acid excretion through herbs such as Smilax glabra and Plantago asiatica, thus having a certain auxiliary effect in lowering uric acid. Its compound design combines "clearing heat and dampness" with "activating blood circulation and removing blood stasis," regulating the body's metabolism from multiple targets. It relieves symptoms while also addressing the underlying causes, providing a more comprehensive solution for the treatment of gouty arthritis. Detailed Implementation

[0021] This invention provides a topical Chinese medicine ointment for treating acute gouty arthritis, comprising the following components in parts by weight: rhubarb 18-22 parts, turmeric 20-26 parts, phellodendron bark 15-19 parts, indigo naturalis 15-19 parts, smilax glabra 15-19 parts, clematis chinensis 14-18 parts, peony bark 14-18 parts, lycopus lucidus 14-18 parts, plantain seed 10-14 parts, fangji 8-12 parts, corydalis yanhusuo 8-12 parts, and licorice root 5-9 parts; The preferred ingredients are: rhubarb 19-21 parts, turmeric 21-25 parts, phellodendron bark 16-18 parts, indigo naturalis 16-18 parts, smilax glabra 16-18 parts, clematis chinensis 15-17 parts, peony bark 15-17 parts, eupatorium fortunei 15-17 parts, plantain seed 11-13 parts, fangji 9-11 parts, corydalis yanhusuo 9-11 parts, and licorice root 6-8 parts. Further preferred ingredients include 20 parts rhubarb, 22-24 parts turmeric, 17 parts phellodendron bark, 17 parts indigo naturalis, 17 parts smilax glabra, 16 parts clematis root, 16 parts peony bark, 16 parts lycopus lucidus, 12 parts plantain seed, 10 parts fangji, 10 parts corydalis rhizome, and 7 parts licorice root. More preferably, the ingredients are: 20 parts rhubarb, 23 parts turmeric, 17 parts phellodendron bark, 17 parts indigo naturalis, 17 parts smilax glabra, 16 parts clematis root bark, 16 parts peony bark, 16 parts lycopus lucidus, 12 parts plantain seed, 10 parts fangji, 10 parts corydalis rhizome, and 7 parts licorice root.

[0022] This invention also provides a method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis, comprising the following steps: (1) Rhubarb, Phellodendron bark, Smilax glabra, Clematis chinensis, Lycopus lucidus, Plantago asiatica, Stephania tetrandra, and Glycyrrhiza uralensis are mixed to obtain material 1; (2) Mix the material 1 with water, boil, filter, and obtain filtrate; (3) The filtrate is concentrated to obtain a clear extract; (4) Mix turmeric, peony bark, and corydalis to obtain material 2; (5) Extract the material 2 by reflux with ethanol to obtain an alcohol extract, and then concentrate the extract after recovering the ethanol. (6) Grind the indigo to obtain indigo powder; (7) Mix the clear paste obtained in step (3), the extract obtained in step (5), the indigo powder obtained in step (6), and the matrix.

[0023] In this invention, the mass ratio of material 1 to water in step (2) is 1:3~5; preferably 1:4.

[0024] In this invention, the simmering time in step (2) is 100-160 min; preferably 110-150 min; more preferably 120-140 min; and even more preferably 130 min.

[0025] In this invention, step (3) is concentrated to a clear paste with a relative density of 1.12 to 1.18 at 60°C; preferably 1.13 to 1.17; more preferably 1.14 to 1.16; and even more preferably 1.15.

[0026] In this invention, the volume concentration of ethanol in step (5) is 62-68%; preferably 63-67%; more preferably 64-66%; and even more preferably 65%.

[0027] In this invention, the ratio of material 2 to ethanol in step (5) is 1g:6~10ml; preferably 1g:7~9ml; and more preferably 1g:8ml.

[0028] In this invention, the reflux extraction time in step (5) is 70-100 min and the number of extractions is 2-3 times; preferably, the reflux extraction time is 80-90 min and the number of extractions is 3 times; more preferably, the reflux extraction time is 85 min and the number of extractions is 3 times.

[0029] In this invention, the particle size of the indigo powder in step (6) is 80-120 mesh; preferably 90-110 mesh; and more preferably 100 mesh.

[0030] In this invention, the addition ratio of the matrix in step (7) is 2 to 4 times the mass of the extract, extract, and indigo powder; preferably 3 times.

[0031] In this invention, the matrix is ​​coconut oil and beeswax in a mass ratio of 3 to 5:1; preferably 4:1.

[0032] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0033] Example 1

[0034] A topical Chinese medicine ointment for treating acute gouty arthritis is composed of the following components in parts by weight: 18 parts rhubarb, 20 parts turmeric, 15 parts phellodendron bark, 15 parts indigo naturalis, 15 parts smilax glabra, 14 parts clematis root bark, 14 parts peony bark, 14 parts lycopus lucidus, 10 parts plantain seed, 8 parts fangji, 8 parts corydalis rhizome, and 5 parts licorice root.

[0035] The preparation method of the topical Chinese medicine ointment for treating acute gouty arthritis includes the following steps: (1) Rhubarb, Phellodendron bark, Smilax glabra, Clematis chinensis, Lycopus lucidus, Plantago asiatica, Stephania tetrandra, and Glycyrrhiza uralensis are mixed to obtain material 1; (2) Mix the material 1 with water at a mass ratio of 1:3, boil for 100 minutes, filter, and obtain the filtrate; (3) Concentrate the filtrate to a clear extract with a relative density of 1.12 at 60°C; (4) Mix turmeric, peony bark, and corydalis to obtain material 2; (5) The material 2 was refluxed with 62% ethanol (material-liquid ratio 1g:6ml) to obtain an ethanol extract. The ethanol was recovered and the extract was concentrated to obtain an extract. The reflux extraction time was 70min and the extraction was performed twice. (6) After grinding the indigo, indigo powder (80 mesh) is obtained. (7) Mix the clear paste obtained in step (3), the extract obtained in step (5), and the indigo powder obtained in step (6), and add a matrix (coconut oil and beeswax in a mass ratio of 3:1) twice the mass of the mixture.

[0036] Example 2

[0037] A topical Chinese medicine ointment for treating acute gouty arthritis is composed of the following components in parts by weight: rhubarb 22 parts, turmeric 26 parts, phellodendron bark 19 parts, indigo naturalis 19 parts, smilax glabra 19 parts, clematis 18 parts, peony bark 18 parts, lycopus lucidus 18 parts, plantain seed 14 parts, fangji 12 parts, corydalis yanhusuo 12 parts, and licorice 9 parts.

[0038] The preparation method of the topical Chinese medicine ointment for treating acute gouty arthritis includes the following steps: (1) Rhubarb, Phellodendron bark, Smilax glabra, Clematis chinensis, Lycopus lucidus, Plantago asiatica, Stephania tetrandra, and Glycyrrhiza uralensis are mixed to obtain material 1; (2) Mix the material 1 with water at a mass ratio of 1:5, boil for 160 minutes, filter, and obtain filtrate; (3) Concentrate the filtrate to a clear extract with a relative density of 1.18 at 60°C; (4) Mix turmeric, peony bark, and corydalis to obtain material 2; (5) The material 2 was refluxed with 68% ethanol (material-liquid ratio 1g:10ml) to obtain an ethanol extract. The ethanol was recovered and the extract was concentrated to obtain an extract. The reflux extraction time was 100min and the extraction was performed 3 times. (6) After grinding the indigo, indigo powder (120 mesh) is obtained. (7) Mix the clear paste obtained in step (3), the extract obtained in step (5), and the indigo powder obtained in step (6), and add a matrix (coconut oil and beeswax in a mass ratio of 5:1) with a mass of 4 times the mass of the mixture.

[0039] Example 3

[0040] A topical Chinese medicine ointment for treating acute gouty arthritis is composed of the following components in parts by weight: 20 parts rhubarb, 23 parts turmeric, 17 parts phellodendron bark, 17 parts indigo naturalis, 17 parts smilax glabra, 16 parts clematis root bark, 16 parts peony bark, 16 parts lycopus lucidus, 12 parts plantain seed, 10 parts fangji, 10 parts corydalis rhizome, and 7 parts licorice root.

[0041] The preparation method of the topical Chinese medicine ointment for treating acute gouty arthritis includes the following steps: (1) Rhubarb, Phellodendron bark, Smilax glabra, Clematis chinensis, Lycopus lucidus, Plantago asiatica, Stephania tetrandra, and Glycyrrhiza uralensis are mixed to obtain material 1; (2) Mix the material 1 with water at a mass ratio of 1:4, boil for 130 minutes, filter, and obtain the filtrate; (3) Concentrate the filtrate to a clear paste with a relative density of 1.15 at 60°C; (4) Mix turmeric, peony bark, and corydalis to obtain material 2; (5) The material 2 was extracted by reflux with 65% ethanol (material-liquid ratio 1g:8ml) to obtain an ethanol extract. The ethanol was recovered and the extract was concentrated to obtain an extract. The reflux extraction time was 85min and the extraction was performed 3 times. (6) Grind the indigo to obtain indigo powder (100 mesh). (7) Mix the clear paste obtained in step (3), the extract obtained in step (5), and the indigo powder obtained in step (6), and add a matrix (coconut oil and beeswax in a mass ratio of 4:1) three times the mass of the mixture.

[0042] Experimental Example 1

[0043] Patient data: Sixty patients with acute gouty arthritis (diagnostic criteria based on the 1977 American College of Rheumatology (ACR) diagnostic criteria) from the outpatient and inpatient departments of the Nephrology Department of Shanghai Sixth People's Hospital Jinshan Branch were selected and randomly divided into a treatment group and a control group (30 patients in each group, at a 1:1 ratio). There were no statistically significant differences in general characteristics between the two groups. P >0.05), see Table 1.

[0044] Table 1 Patient Overview

[0045] The treatment group used the product prepared by the method in Example 3, applied topically once daily for 7 days.

[0046] The control group received celecoxib orally once daily for 7 days.

[0047] Apart from the differences in medication, both experimental groups received the same basic treatment, specifically: as much bed rest as possible, a low-purine diet, plenty of water, and avoidance of medications that affect uric acid excretion or increase uric acid reabsorption. After treatment, the VAS scores, white blood cell counts, and CRP (C-reactive protein) and UA (uric acid) levels were again recorded for each experimental group, and the average values ​​were taken, as shown in Tables 2-5.

[0048] Table 2 Patient VAS scores

[0049] Table 3. White blood cell count in patients (×10) 9 )

[0050] Table 4. CRP (mg / L)

[0051] Table 5. UA (mmol / L)

[0052] Table 2 shows that the VAS scores before treatment were similar in both the treatment and control groups, indicating that the initial pain levels were similar in both groups. After treatment, the scores in both groups decreased significantly, indicating that both treatment methods were effective in relieving pain. The similar degree of improvement in both groups suggests that the analgesic effect of the topical herbal ointment is comparable to that of oral celecoxib.

[0053] Table 3 shows that the white blood cell counts were similar before treatment, reflecting comparable inflammation levels. After treatment, all counts decreased significantly, indicating that both the herbal ointment and celecoxib could inhibit the inflammatory response. The reduction in white blood cell count was slightly greater in the treatment group than in the control group, possibly suggesting that the herbal ointment has certain advantages in local anti-inflammatory effects.

[0054] Table 4 shows that CRP levels were high before treatment, consistent with the characteristics of acute inflammation. After treatment, CRP levels decreased significantly, indicating that both therapies effectively reduced systemic inflammation.

[0055] Table 5 shows that serum uric acid levels were all above normal before treatment. After treatment, levels decreased, but remained high, possibly because short-term treatment did not directly affect uric acid metabolism. The reduction in uric acid levels was slightly lower in the herbal ointment group, suggesting that its effect is more focused on anti-inflammatory and analgesic rather than directly lowering uric acid.

[0056] In summary, it is easy to see that the topical Chinese medicine ointment provided by this invention is comparable to oral celecoxib in relieving pain and inhibiting inflammation, and may even be superior in local anti-inflammatory effects.

[0057] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A topical Chinese medicine ointment for treating acute gouty arthritis, characterized in that, The composition includes the following components in parts by weight: rhubarb 18-22 parts, turmeric 20-26 parts, phellodendron bark 15-19 parts, indigo naturalis 15-19 parts, smilax glabra 15-19 parts, clematis chinensis 14-18 parts, peony bark 14-18 parts, lycopus lucidus 14-18 parts, plantain seed 10-14 parts, fangji 8-12 parts, corydalis yanhusuo 8-12 parts, and licorice 5-9 parts.

2. The method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis as described in claim 1, characterized in that, Includes the following steps: (1) Rhubarb, Phellodendron bark, Smilax glabra, Clematis chinensis, Lycopus lucidus, Plantago asiatica, Stephania tetrandra, and Glycyrrhiza uralensis are mixed to obtain material 1; (2) Mix the material 1 with water, boil, filter, and obtain filtrate; (3) The filtrate is concentrated to obtain a clear extract; (4) Mix turmeric, peony bark, and corydalis to obtain material 2; (5) Extract the material 2 by reflux with ethanol to obtain an alcohol extract, and then concentrate the extract after recovering the ethanol. (6) Grind the indigo to obtain indigo powder; (7) Mix the clear paste obtained in step (3), the extract obtained in step (5), the indigo powder obtained in step (6), and the matrix.

3. The method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis according to claim 2, characterized in that, In step (2), the mass ratio of material 1 to water is 1:3~5; the decocting time is 100~160min.

4. The method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis according to claim 2, characterized in that, Step (3) Concentrate to a clear paste with a relative density of 1.12~1.18 at 60℃.

5. The method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis according to claim 2, characterized in that, The volume concentration of ethanol in step (5) is 62-68%.

6. The method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis according to claim 2, characterized in that, In step (5), the ratio of material 2 to ethanol is 1g:6~10ml.

7. The method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis according to claim 2, characterized in that, The reflux extraction time in step (5) is 70-100 min, and the number of extractions is 2-3.

8. The method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis according to claim 2, characterized in that, The particle size of the indigo powder in step (6) is 80~120 mesh.

9. The method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis according to claim 2, characterized in that, The addition ratio of the matrix in step (7) is 2 to 4 times the combined mass of the extract, extract, and indigo powder.

10. A method for preparing a topical Chinese medicine ointment for treating acute gouty arthritis according to claim 2 or 9, characterized in that, The matrix is ​​coconut oil and beeswax in a mass ratio of 3 to 5:1.

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