Traditional Chinese medicine gel for treating gout and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine gel for treating gout and a preparation method thereof, and the traditional Chinese medicine gel for treating gout comprises the following components in parts by weight: 16-20 parts of caulis sinomenii, 15-19 parts of garden balsam stem, 15-19 parts of mirabilite, 15-19 parts of rheum officinale, 4-8 parts of mint, 15-19 parts of golden cypress and 6-10 parts of asarum. The preparation method of the traditional Chinese medicine gel for treating gout comprises the following steps: drying the caulis sinomenii, the garden balsam stem, the mirabilite, the radix et rhizoma rhei, the herba menthae, the cortex phellodendri and the herba asari for 2.5-3 hours in an environment with the temperature of 35-40 DEG C and the pressure of-0.07 to-0.05 MPa; crushing the dried caulis sinomenii, garden balsam stem, mirabilite, rheum officinale, mint, golden cypress and asarum to 300 meshes or above, and screening to obtain fine powder; and mixing the fine powder into a blank gel matrix, and fully stirring to generate the traditional Chinese medicine gel for treating gout. Therefore, the composition has the advantages of quick absorption effect, good relieving and repairing effects, high safety, convenience in use and the like.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparations, specifically to a traditional Chinese medicine gel for treating gout and its preparation method. Background Technology

[0002] Gout is a metabolic disease caused by abnormal uric acid metabolism, which leads to elevated blood uric acid levels and the deposition of urate crystals in joints, kidneys, and other parts of the body. Clinically, it is mainly characterized by redness, swelling, heat, and pain in the joints, as well as limited mobility. During acute attacks, the pain is severe and seriously affects the patient's quality of life.

[0003] Currently, clinical treatments for gout mainly include oral uric acid-lowering drugs, anti-inflammatory and analgesic drugs, and topical preparations. While oral medications can provide systemic treatment, some may have potential effects on the gastrointestinal tract, liver, and kidney function, and they also tend to have a slow onset of action and require long-term use. Topical preparations, because they act directly on the affected area, have a relatively high safety profile and have become an important adjunctive treatment for gout. However, existing topical preparations still have room for improvement in terms of skin absorption efficiency, the timeliness of inflammation relief, and ease of use, and cannot fully meet the clinical needs for rapid symptom relief and gentle repair of damaged tissues. Summary of the Invention

[0004] The present invention aims to at least partially solve the technical problems in the above-mentioned technologies.

[0005] Therefore, this invention discloses a traditional Chinese medicine gel for treating gout, comprising, by weight:

[0006] 16 to 20 parts of *Sinomenium acutum*, 15 to 19 parts of *Clematis chinensis*, 15 to 19 parts of Glauber's salt, 15 to 19 parts of rhubarb, 4 to 8 parts of peppermint, 15 to 19 parts of *Phellodendron amurense*, and 6 to 10 parts of *Asarum heterotropoides*.

[0007] Meanwhile, another aspect of the present invention discloses a method for preparing the traditional Chinese medicine gel for treating gout, comprising the following steps:

[0008] S1: Dry the following herbs in an environment of 35 to 40 degrees Celsius and -0.07 to -0.05 MPa for 2.5 to 3 hours: *Sinomenium acutum*, *Clematis chinensis*, *Mildis*, *Rheum palmatum*, *Mentha haplocalyx*, *Phellodendron amurense*, and *Asarum heterotropoides*.

[0009] S2: Pulverize the dried Chinese pine, clematis root, mirabilite, rhubarb, mint, phellodendron bark, and asarum to 300 mesh or finer, and then sieve to obtain fine powder;

[0010] S3: Mix the fine powder into the blank gel matrix and stir thoroughly to generate a traditional Chinese medicine gel for the treatment of gout.

[0011] In addition, the method for preparing the traditional Chinese medicine gel for treating gout disclosed in this invention may also have the following additional technical features:

[0012] It should be noted that the blank gel matrix in step S3 is prepared by the following steps:

[0013] S3.1.1: By weight, prepare 1 to 1.5 parts of water-soluble gel matrix, 1 to 2 parts of purified water, 0.075 to 0.15 parts of humectant and 0.03 to 0.05 parts of preservative;

[0014] S3.1.2: Place purified water, humectant and preservative into a reaction vessel and stir for 5 to 6 minutes at 20 to 25 degrees Celsius to generate a mixed solution;

[0015] S3.1.3: Place the water-soluble gel matrix and the mixed solution into a reaction vessel and stir for 1.5 to 2 hours at 20 to 25 degrees Celsius to generate a viscous liquid;

[0016] S3.1.4: Add a neutralizing agent to the viscous liquid until the pH of the viscous liquid is 6 to 6.5. The final product is the blank gel matrix.

[0017] It should be noted that the water-soluble gel matrix includes, but is not limited to, xanthan gum; the humectants include, but are not limited to, glycerin and propylene glycol; and the preservatives include, but are not limited to, phenoxyethanol.

[0018] It should be noted that when the viscous liquid is acidic, the neutralizing agent includes, but is not limited to, triethanolamine; when the viscous liquid is alkaline, the neutralizing agent includes, but is not limited to, citric acid, lactic acid, and malic acid.

[0019] It should be noted that in step S3, the fine powder is mixed into the blank gel matrix and stirred thoroughly to generate a traditional Chinese medicine gel for treating gout, specifically as follows:

[0020] S3.2.1: Prepare 1 part fine powder and 15 to 17 parts blank gel matrix by weight;

[0021] S3.2.2: Place the fine powder and blank gel matrix into a reaction vessel and stir for 15 to 20 minutes at 25 to 30 degrees Celsius to generate a preliminary mixture;

[0022] S3.2.3: Place the preliminary mixture into a vacuum homogenizer and homogenize for 30 to 35 minutes at 25 to 30 degrees Celsius and -0.08 to -0.07 MPa to produce a traditional Chinese medicine gel for the treatment of gout.

[0023] It should be noted that its preparation method also includes the following steps:

[0024] S4: By weight, prepare 1 to 1.5 parts of Chinese herbal gel for treating gout and 0.01 to 0.02 parts of menthol;

[0025] S5: Place the traditional Chinese medicine gel for treating gout and menthol into a reaction vessel and stir for 15 to 20 minutes at 25 to 30 degrees Celsius to produce the final traditional Chinese medicine gel for treating gout.

[0026] The traditional Chinese medicine gel for treating gout disclosed in this invention and its preparation method have the advantages of rapid absorption and effectiveness, good relief and repair effects, high safety and convenient use.

[0027] Additional features and advantages of this invention will be set forth in the description which follows, or may be learned by practicing the invention. Detailed Implementation

[0028] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0029] A traditional Chinese medicine gel for treating gout, comprising, by weight:

[0030] 16 to 20 parts of *Sinomenium acutum*, 15 to 19 parts of *Clematis chinensis*, 15 to 19 parts of Glauber's salt, 15 to 19 parts of rhubarb, 4 to 8 parts of peppermint, 15 to 19 parts of *Phellodendron amurense*, and 6 to 10 parts of *Asarum heterotropoides*.

[0031] The preparation method of this traditional Chinese medicine gel for treating gout includes the following steps:

[0032] S1: Dry the following herbs in an environment of 35 to 40 degrees Celsius and -0.07 to -0.05 MPa for 2.5 to 3 hours: *Sinomenium acutum*, *Clematis chinensis*, *Mildis*, *Rheum palmatum*, *Mentha haplocalyx*, *Phellodendron amurense*, and *Asarum heterotropoides*.

[0033] S2: Pulverize the dried Chinese pine, clematis root, mirabilite, rhubarb, mint, phellodendron bark, and asarum to 300 mesh or finer, and then sieve to obtain fine powder;

[0034] S3: Mix the fine powder into the blank gel matrix and stir thoroughly to generate a traditional Chinese medicine gel for the treatment of gout;

[0035] S3.1.1: By weight, prepare 1 to 1.5 parts of water-soluble gel matrix, 1 to 2 parts of purified water, 0.075 to 0.15 parts of humectant and 0.03 to 0.05 parts of preservative;

[0036] S3.1.2: Place purified water, humectant and preservative into a reaction vessel and stir for 5 to 6 minutes at 20 to 25 degrees Celsius to generate a mixed solution;

[0037] S3.1.3: Place the water-soluble gel matrix and the mixed solution into a reaction vessel and stir for 1.5 to 2 hours at 20 to 25 degrees Celsius to generate a viscous liquid;

[0038] S3.1.4: Add a neutralizing agent to the viscous liquid until the pH of the viscous liquid is 6 to 6.5. The final product is the blank gel matrix.

[0039] It should be noted that the water-soluble gel matrix includes, but is not limited to, xanthan gum; the humectants include, but are not limited to, glycerin and propylene glycol; and the preservatives include, but are not limited to, phenoxyethanol.

[0040] It should be noted that when the viscous liquid is acidic, the neutralizing agent includes, but is not limited to, triethanolamine; when the viscous liquid is alkaline, the neutralizing agent includes, but is not limited to, citric acid, lactic acid, and malic acid.

[0041] It should be noted that the fine powder is mixed into the blank gel matrix and stirred thoroughly to generate a traditional Chinese medicine gel for the treatment of gout, specifically as follows:

[0042] S3.2.1: Prepare 1 part fine powder and 15 to 17 parts blank gel matrix by weight;

[0043] S3.2.2: Place the fine powder and blank gel matrix into a reaction vessel and stir for 15 to 20 minutes at 25 to 30 degrees Celsius to generate a preliminary mixture;

[0044] S3.2.3: Place the preliminary mixture into a vacuum homogenizer and homogenize for 30 to 35 minutes at 25 to 30 degrees Celsius and -0.08 to -0.07 MPa to produce a traditional Chinese medicine gel for the treatment of gout.

[0045] S4: By weight, prepare 1 to 1.5 parts of Chinese herbal gel for treating gout and 0.01 to 0.02 parts of menthol;

[0046] S5: Place the traditional Chinese medicine gel for treating gout and menthol into a reaction vessel and stir for 15 to 20 minutes at 25 to 30 degrees Celsius to produce the final traditional Chinese medicine gel for treating gout.

[0047] In Embodiment 1 of the present invention:

[0048] This traditional Chinese medicine gel for treating gout comprises, by weight:

[0049] 16 parts of *Sinomenium acutum*, 15 parts of *Clematis chinensis*, 15 parts of Glauber's salt, 15 parts of rhubarb, 4 parts of mint, 15 parts of *Phellodendron amurense*, and 6 parts of *Asarum heterotropoides*.

[0050] The preparation method of this traditional Chinese medicine gel for treating gout includes the following steps:

[0051] S1: Dry the following herbs (including *Sinomenium acutum*, *Clematis chinensis*, *Mildrum sodium*, rhubarb, peppermint, *Phellodendron amurense*, and *Asarum heterotropoides*) at 37.5 degrees Celsius and -0.06 MPa for 2.75 hours.

[0052] S2: Pulverize the dried Chinese pine, clematis, mirabilite, rhubarb, mint, phellodendron bark and asarum to 300 mesh and sieve to obtain fine powder;

[0053] S3: Mix the fine powder into the blank gel matrix and stir thoroughly to generate a traditional Chinese medicine gel for the treatment of gout;

[0054] S3.1.1: By weight, prepare 1.25 parts of water-soluble gel matrix, 1.5 parts of purified water, 0.075 to 0.1125 parts of humectant and 0.04 parts of preservative;

[0055] S3.1.2: Place purified water, humectant and preservative into a reaction vessel and stir for 5.5 minutes at 22.5 degrees Celsius to generate a mixed solution;

[0056] S3.1.3: Place the water-soluble gel matrix and the mixed solution into a reaction vessel and stir at 22.5 degrees Celsius for 1.75 hours to generate a viscous liquid;

[0057] S3.1.4: Add a neutralizing agent to the viscous liquid until the pH value of the viscous liquid is 6.25. The final product is the blank gel matrix.

[0058] The water-soluble gel matrix is ​​xanthan gum, the humectant is glycerin, and the preservative is phenoxyethanol;

[0059] The fine powder was mixed into the blank gel matrix and stirred thoroughly to generate a traditional Chinese medicine gel for the treatment of gout, specifically as follows:

[0060] S3.2.1: Prepare 1 part fine powder and 16 parts blank gel matrix by weight;

[0061] S3.2.2: Place the fine powder and blank gel matrix into a reaction vessel and stir at 22.5 degrees Celsius for 17.5 minutes to generate a preliminary mixture;

[0062] S3.2.3: The preliminary mixture is placed in a vacuum homogenizer and homogenized for 32.5 minutes at 22.5 degrees Celsius and -0.075 MPa to produce a traditional Chinese medicine gel for the treatment of gout.

[0063] S4: By weight, prepare 1.25 parts of Chinese herbal gel for treating gout and 0.015 parts of menthol;

[0064] S5: Place the traditional Chinese medicine gel for treating gout and menthol into a reaction vessel and stir for 17.5 minutes at 22.5 degrees Celsius to produce the final traditional Chinese medicine gel for treating gout.

[0065] In Embodiment 2 of the present invention:

[0066] This traditional Chinese medicine gel for treating gout comprises, by weight:

[0067] 18 parts of *Sinomenium acutum*, 17 parts of *Clematis chinensis*, 17 parts of Glauber's salt, 17 parts of rhubarb, 6 parts of mint, 17 parts of *Phellodendron chinense*, and 8 parts of *Asarum heterotropoides*.

[0068] In this embodiment, the preparation method of the traditional Chinese medicine gel used to treat gout is as described in the above embodiment, and will not be repeated here.

[0069] In Embodiment 3 of the present invention:

[0070] This traditional Chinese medicine gel for treating gout comprises, by weight:

[0071] 20 parts of *Sinomenium acutum*, 19 parts of *Clematis chinensis*, 19 parts of Glauber's salt, 19 parts of rhubarb, 8 parts of mint, 19 parts of *Phellodendron amurense*, and 10 parts of *Asarum heterotropoides*.

[0072] In this embodiment, the preparation method of the traditional Chinese medicine gel used to treat gout is as described in the above embodiment, and will not be repeated here.

[0073] KS experimental verification of Examples 1, 2 and 3:

[0074] Between March 2022 and March 2025, 105 patients with gout were randomly selected and treated with the traditional Chinese medicine gel used to treat gout, as shown in Table 1 below.

[0075] Table 1. Sample of gout patients

[0076] Clinical features Number of cases (n%) Total number of gout patients 105 gender male 72（68.57%） female 33（31.43%） Treatment history: Have you received systemic uric acid-lowering treatment? yes 69（65.71%） no 36（34.29%） ACR gout classification Grade I (Acute Attack Phase) 41（39.05%） Level II (Intermission) 38（36.19%） Grade III (Chronic Phase) 26（24.76%） Joint swelling none 23（21.90%） have 82（78.10%） Serum uric acid (μmol / L) ＜420 17（16.19%） 420-540 59（56.19%） ≥540 29（27.62%） Erythrocyte sedimentation rate (mm / h) ＜20 35（33.33%） 20-40 51（48.57%） ≥40 19（18.10%）

[0077] For Examples 1, 2 and 3, interleukin-1β (IL-1β), a core marker of gout inflammation in synovial fluid, was selected as a key indicator for efficacy evaluation.

[0078] One hundred and five patients with gout were randomly divided into three groups, corresponding to the traditional Chinese medicine gel treatment groups of Examples 1, 2 and 3 of this invention, with 35 patients in each group.

[0079] All patients used the corresponding Chinese herbal gel topically twice a day for 7 consecutive days according to the standard method. Joint fluid samples were collected before treatment and 7 days after treatment, and the concentration of IL-1β in the joint fluid was measured at the same time.

[0080] The concentration data of IL-1β in the joint fluid before and after treatment in the three groups of patients were verified by KS (Kolmogorov-Smirnov) test to see if they conformed to a normal distribution. The statistical results are shown in Table 2.

[0081] Table 2 KS Validation Results

[0082] KS verification Example 1 Group Example 2 group Example 3 Group D statistic 0.0912 0.0876 0.0935 probability value ＞0.1000 ＞0.1000 ＞0.1000 Conclusion Judgment Yes Yes Yes Concise symbolic expression ns ns ns Sample size 7035 cases × (before treatment + after treatment) 7035 cases × (before treatment + after treatment) 7035 cases × (before treatment + after treatment)

[0083] Based on the normal distribution results validated by KS, ANOVA analysis was used to compare the changes in IL-1β concentration before and after treatment in each group of patients. The specific results are as follows:

[0084] In Example 1 group, the IL-1β concentration before treatment was (187.62±35.41) pg / mL, and after treatment it was (89.37±21.56) pg / mL, with a statistically significant difference (P<0.05).

[0085] In Example 2 group, the IL-1β concentration before treatment was (192.45±38.12) pg / mL, and after treatment it was (76.53±18.92) pg / mL, with a statistically significant difference (P<0.05).

[0086] In Example 3 group, the IL-1β concentration before treatment was (189.73±36.85) pg / mL, and after treatment it was (72.19±17.64) pg / mL, with a statistically significant difference (P<0.05).

[0087] After treatment, the IL-1β concentration in all three groups was significantly lower than before treatment, and there was no significant difference in efficacy between the groups (P>0.05). This confirms that the traditional Chinese medicine gels of Examples 1, 2 and 3 of this invention can effectively reduce the concentration of inflammatory core markers in the synovial fluid of gout patients, have clear anti-inflammatory and analgesic effects, and the statistical results are reliable.

[0088] In summary, the traditional Chinese medicine gel for treating gout and its preparation method disclosed in this invention have the advantages of rapid absorption and effectiveness, good relief and repair effects, high safety, and convenient use.

[0089] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A traditional Chinese medicine gel for treating gout, characterized in that, By weight parts, comprising: 16 to 20 parts of sinomenium, 15 to 19 parts of radix sileris, 15 to 19 parts of mirabilite, 15 to 19 parts of rhubarb, 4 to 8 parts of mint, 15 to 19 parts of phellodendri cortex and 6 to 10 parts of asarum.

2. The traditional Chinese medicine gel for treating gout according to claim 1, characterized in that, The preparation method thereof, comprising the following steps: S1: drying sinomenium, radix sileris, mirabilite, rhubarb, mint, phellodendri cortex and asarum at 35 to 40 degrees Celsius and-0.07 to-0.05 megapascal for 2.5 to 3 hours; S2: crushing the dried sinomenium, radix sileris, mirabilite, rhubarb, mint, phellodendri cortex and asarum to 300 meshes and above, and screening to obtain fine powder; S3: mixing the fine powder into the blank gel matrix and stirring thoroughly to generate the traditional Chinese medicine gel for treating gout.

3. The preparation method of the traditional Chinese medicine gel for treating gout according to claim 2, characterized in that, In step S3, the blank gel matrix, the preparation method thereof, comprising the following steps: S3.1.1: preparing 1 to 1.5 parts of water-soluble gel matrix, 1 to 2 parts of pure water, 0.075 to 0.15 parts of humectant and 0.03 to 0.05 parts of preservative by weight parts; S3.1.2: putting the pure water, humectant and preservative into the reaction kettle, stirring at 20 to 25 degrees Celsius for 5 to 6 minutes to generate a mixed solution; S3.1.3: putting the water-soluble gel matrix and the mixed solution into the reaction kettle, stirring at 20 to 25 degrees Celsius for 1.5 to 2 hours to generate a viscous liquid; S3.1.4: adding a neutralizing agent to the viscous liquid until the pH value of the viscous liquid is 6 to 6.5, and the final product is the blank gel matrix.

4. The method for preparing the traditional Chinese medicine gel for treating gout as described in claim 3, characterized in that, The water-soluble gel matrix includes but is not limited to xanthan gum, the humectant includes but is not limited to glycerol and propylene glycol, and the preservative includes but is not limited to phenoxyethanol.

5. The preparation method of the traditional Chinese medicine gel for treating gout according to claim 3, characterized in that, When the viscous liquid is acidic, the neutralizing agent includes but is not limited to triethanolamine, and when the viscous liquid is alkaline, the neutralizing agent includes but is not limited to citric acid, lactic acid and malic acid.

6. The preparation method of the traditional Chinese medicine gel for treating gout according to claim 2, characterized in that, In step S3, the fine powder is mixed into the blank gel matrix and stirred thoroughly to generate the traditional Chinese medicine gel for treating gout, specifically: S3.2.1: preparing 1 part of fine powder and 15 to 17 parts of blank gel matrix by weight parts; S3.2.2: putting the fine powder and the blank gel matrix into the reaction kettle, stirring at 25 to 30 degrees Celsius for 15 to 20 minutes to generate a preliminary mixture; S3.2.3: putting the preliminary mixture into a vacuum homogenizing emulsifier, homogenizing at 25 to 30 degrees Celsius and-0.08 to-0.07 megapascal for 30 to 35 minutes to generate the traditional Chinese medicine gel for treating gout.

7. The preparation method of the traditional Chinese medicine gel for treating gout according to claim 2, characterized in that, The preparation method thereof, further comprising the following steps: S4: preparing 1 to 1.5 parts of the traditional Chinese medicine gel for treating gout and 0.01 to 0.02 parts of menthol by weight; S5: putting the traditional Chinese medicine gel for treating gout and menthol into the reaction kettle, stirring at 25 to 30 degrees Celsius for 15 to 20 minutes to generate the final traditional Chinese medicine gel for treating gout.