Gel for treating arthritis and preparation method thereof

Abstract

The invention relates to the field of traditional Chinese medicine preparations, and discloses a gel for treating arthritis and a preparation method thereof, the gel is prepared from the following raw materials in percentage by mass: 1.0-2.0% of carbomer-940, 5-15% of glycerol, 0.25-0.75% of triethanolamine, 10% of angelica sini decoction concentrated solution and the balance of distilled water; the angelica sini decoction concentrated solution comprises the following raw materials in parts by weight: 8-10 parts of angelica, 8-10 parts of cassia twig, 8-10 parts of Chinese herbaceous peony, 2-4 parts of asarum, 5-7 parts of liquorice, 5-7 parts of tetrapanax papyriferus and 4-6 parts of jujube. The preparation method of the gel for treating arthritis comprises the following steps: S1, preparing an angelica sini decoction concentrated solution; s2, preparing a gel matrix; s3, mixing the angelica sini decoction concentrated solution with the gel matrix; s4, adjusting the pH value; and S5, inspecting and packaging a finished product. The gel for treating arthritis can improve the drug effect, enhance the drug permeability and targeting property, improve the patient experience, is convenient to use, reduces the pain, can reduce the side effect risk, and provides a better scheme for arthritis treatment.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine preparations, and in particular to a gel for treating arthritis and a preparation method thereof. Background Art

[0002] Arthritis refers to an inflammatory disease of the joints and the tissues surrounding them. It is a common chronic disease that can affect one or more joints. Symptoms of arthritis include joint pain, swelling, stiffness, and decreased function. Depending on the cause, arthritis can be divided into several types, the most common of which are osteoarthritis and rheumatoid arthritis. Osteoarthritis is a degenerative disease that mainly involves the wear and tear of joint cartilage, leading to joint pain and stiffness. The disease is usually associated with aging, but can also be triggered by joint injuries, obesity, genetics, and other factors. Rheumatoid arthritis is an autoimmune disease in which the immune system mistakenly attacks the joints, causing joint inflammation, pain, and swelling. Rheumatoid arthritis may also affect other organs and systems throughout the body, with symptoms including fatigue, fever, weight loss, and more.

[0003] Treatments for arthritis include medication, physical therapy, and surgery. Medication mainly includes nonsteroidal anti-inflammatory drugs, analgesics, disease-modifying antirheumatic drugs, and arthritis treatment gels. Currently, most arthritis treatment gels have uneven rates during drug release, resulting in unstable treatment effects; some synthetic polymers have poor biocompatibility in the body and may cause local inflammatory reactions. Summary of the invention

[0004] In view of the above-mentioned deficiencies in the prior art, the present invention provides a gel for treating arthritis and a preparation method thereof, which improves the efficacy of the gel, enhances drug permeability and targeting, and improves patient experience.

[0005] In order to achieve the above-mentioned invention object, the technical scheme adopted by the present invention is: a gel for treating arthritis, comprising the following raw materials in percentage by mass: 1.0% to 2.0% of carbomer-940, 5% to 15% of glycerol, 0.25% to 0.75% of triethanolamine, 10% of Danggui Sini Decoction concentrate and the remainder of distilled water;

[0006] The concentrated Danggui Sini Decoction comprises the following raw materials in weight ratio: 8-10 parts of angelica, 8-10 parts of cassia twig, 8-10 parts of peony root, 2-4 parts of asarum, 5-7 parts of liquorice, 5-7 parts of tongcao and 4-6 parts of jujube.

[0007] The beneficial effects of the present invention are as follows: Carbomer-940, as a high molecular polymer, has good water solubility and thickening effect, can make the gel texture uniform, easy to apply, and can form a protective film on the skin surface to enhance the lasting effect of the drug. Glycerin, as a moisturizer, can increase the moisture of the skin, improve the dry skin symptoms caused by arthritis, and also help the penetration of the drug. Triethanolamine, as a buffer, can adjust the pH value of the gel to make it closer to the natural pH value of the skin and reduce irritation to the skin. Angelica has the effect of nourishing blood and activating blood circulation, and can improve the deficiency of qi and blood caused by arthritis; cinnamon twig can warm the meridians and dispel cold, and promote blood circulation; peony can activate blood circulation and remove blood stasis, and relieve joint pain; asarum has the effect of dispelling wind and relieving pain; liquorice has the effect of harmonizing various medicines; cyperus can promote diuresis and reduce swelling, and reduce joint swelling; jujube can nourish blood and calm the nerves, and improve the patient's immunity.

[0008] Furthermore, in the gel for treating arthritis, the mass percentage of Carbomer-940 is 1.5%, the mass percentage of glycerol is 10%, and the mass percentage of triethanolamine is 0.5%.

[0009] The beneficial effects of adopting the above further scheme are: the proportion of carbomer-940 is set to 1.5%, which makes the viscosity of the gel moderate, so that it can maintain good spreadability without being too thick, ensuring comfort on the skin. The proportion of glycerol is set to 10%, which significantly improves the moisturizing ability of the gel and also enhances the permeability of other active ingredients, so that the drug can reach the affected area more effectively. The proportion of triethanolamine is 0.5%, which can effectively adjust the pH value and has certain anti-inflammatory properties, further enhancing the therapeutic effect of the gel.

[0010] Furthermore, the method for preparing the gel for treating arthritis comprises the following steps:

[0011] S1, preparing Danggui Sini Decoction concentrated solution: weighing the raw materials of Danggui Sini Decoction concentrated solution, crushing the raw materials, soaking the crushed medicinal materials in 600 mL of distilled water for 30 minutes, heating the soaked medicinal materials together with the distilled water to boiling, keeping boiling for 30 minutes, pouring out the medicinal liquid and filtering the medicinal residue to complete the first decoction; repeating the above decoction and filtering for a total of three decoctions; combining the medicinal liquids obtained from the three decoctions and concentrating them until the volume is reduced to 120 mL;

[0012] S2, preparing a gel matrix: evenly sprinkle carbomer-940 on the surface of 30 mL of distilled water, let it stand for a while to allow the carbomer-940 to swell naturally, and then stir until it is completely dissolved to obtain a carbomer-940 solution;

[0013] S3, mixing the Danggui Sini Tang concentrated solution with the gel matrix: taking 5 ml of the Danggui Sini Tang concentrated solution in S1, and mixing the Danggui Sini Tang concentrated solution with glycerol; adding the mixed solution to the carbomer-940 solution, and mixing them to obtain a gel solution;

[0014] S4, adjusting the pH value: adding triethanolamine to the gel solution of S3, and continuing to add distilled water to the gel solution until the total volume reaches 50 mL, thereby obtaining a gel for treating arthritis;

[0015] S5, finished product inspection and packaging: test the shape, uniformity, ductility, viscosity and pH value of the gel, and pack the gel that passes the inspection into containers for sealed storage.

[0016] The beneficial effects of the present invention are as follows: the gel for treating arthritis of the present invention realizes the perfect combination of effective utilization of traditional Chinese medicine prescriptions and modern drug carrier technology through precisely proportioned raw materials and sophisticated preparation processes, and provides a safe, effective, convenient and comfortable treatment option for arthritis patients. The gel can improve drug efficacy, enhance drug permeability and targeting, improve patient experience, facilitate use and reduce pain, reduce the risk of side effects, and provide a better solution for arthritis treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a flow chart of the preparation method of the gel;

[0018] Figure 2 It is a level analysis curve diagram of Carbomer-940;

[0019] Figure 3 It is the level analysis curve of glycerol;

[0020] Figure 4 This is a curve diagram for the level analysis of triethanolamine. DETAILED DESCRIPTION

[0021] The specific implementation modes of the present invention are described below so that those skilled in the art can understand the present invention. However, it should be clear that the present invention is not limited to the scope of the specific implementation modes. For those of ordinary skill in the art, as long as various changes are within the spirit and scope of the present invention as defined and determined by the attached claims, these changes are obvious, and all inventions and creations utilizing the concept of the present invention are protected.

[0022] like Figure 1 As shown, this embodiment provides a gel for treating arthritis, the raw materials of which include: carbomer-940, glycerol, triethanolamine, Danggui Sini Tang concentrate and distilled water;

[0023] The concentrated Danggui Sini Decoction comprises the following raw materials in weight ratio: 8-10 parts of angelica, 8-10 parts of cassia twig, 8-10 parts of peony root, 2-4 parts of asarum, 5-7 parts of liquorice, 5-7 parts of tongcao and 4-6 parts of jujube.

[0024] The preparation method of the gel for treating arthritis comprises the following steps:

[0025] S1, preparing Danggui Sini Decoction concentrated solution: weighing the raw materials of Danggui Sini Decoction concentrated solution, crushing the raw materials, soaking the crushed medicinal materials in 600 mL of distilled water for 30 minutes, heating the soaked medicinal materials together with the distilled water to boiling, keeping boiling for 30 minutes, pouring out the medicinal liquid and filtering the medicinal residue to complete the first decoction; repeating the above decoction and filtering for a total of three decoctions; combining the medicinal liquids obtained from the three decoctions and concentrating them until the volume is reduced to 120 mL;

[0026] S2, preparing a gel matrix: evenly sprinkle carbomer-940 on the surface of 30 mL of distilled water, let it stand for a while to allow the carbomer-940 to swell naturally, and then stir until it is completely dissolved to obtain a carbomer-940 solution;

[0027] S3, mixing the Danggui Sini Tang concentrated solution with the gel matrix: taking 5 ml of the Danggui Sini Tang concentrated solution in S1, and mixing the Danggui Sini Tang concentrated solution with glycerol; adding the mixed solution to the carbomer-940 solution, and mixing them to obtain a gel solution;

[0028] S4, adjusting the pH value: adding triethanolamine to the gel solution of S3, and continuing to add distilled water to the gel solution until the total volume reaches 50 mL, thereby obtaining a gel for treating arthritis;

[0029] S5, finished product inspection and packaging: test the shape, uniformity, ductility, viscosity and pH value of the gel, and pack the gel that passes the inspection into containers for sealed storage.

[0030] This example uses a single factor to investigate the effect of the amount of Carbomer-940 on the gel properties. The mass percentage of Carbomer-940 in the gel is set to 0.5%, 1%, 1.5%, 2% and 2.5%. According to the above preparation steps, Carbomer-940 is evenly sprinkled on the surface of 30ml distilled water. After sufficient swelling, 5mL of Danggui Sini Decoction Concentrate is added, mixed evenly, and distilled water is added to 50mL, and stirred evenly. The morphology, uniformity, ductility, viscosity, etc. of the Chinese medicine gel are investigated when the mass percentage of Carbomer-940 is 0.5%, 1%, 1.5%, 2%, and 2.5%, and the evaluation indicators are shown in Table 1.

[0031] Table 1:

[0032]

[0033] The morphology, uniformity, extensibility and viscosity of the traditional Chinese medicine gel were scored when the mass percentage of Carbomer-940 was 0.5%, 1%, 1.5%, 2% and 2.5%, and the data in Table 2 were obtained.

[0034] Table 2:

[0035]

[0036] According to the results in Table 2, when the mass percentage of Carbomer-940 is 1.5%, the obtained gel has the best performance, is gel-like, fine and uniform, spreads evenly, and has moderate viscosity; when the mass percentage is 1%, the obtained gel is gel-like, fine and uniform, spreads evenly, and has poor viscosity, with basically no viscosity; when the mass percentage is 2%, the obtained gel is gel-like, has a small amount of particles, spreads evenly, and has a large viscosity; when the mass percentage is 2.5%, the obtained gel is semi-solid, has a small amount of particles, spreads evenly, and has a large viscosity; when the mass percentage is 0.5%, the obtained gel is fluid-like, fine and uniform, spreads evenly, has poor viscosity, and has basically no viscosity. The results of Table 1 are plotted into a curve graph, as shown in FIG. Figure 2 As shown, the horizontal axis is the mass percentage of Carbomer-940, and the vertical axis is the total score of Carbomer-940 at different mass percentages.

[0037] Therefore, the single factor test of Example 2 and Example 3 adopts 1.5% carbomer-940 mass percentage to prepare gel, and the orthogonal test of Example 4 adopts three levels of 1.0%, 1.5% and 2.0% carbomer-940 mass percentage to conduct the test.

[0038] Example 2

[0039] This embodiment uses a single factor to investigate the effect of the amount of glycerol on the gel properties. This embodiment is carried out at room temperature, and the mass percentage of glycerol in the gel is set to 0%, 5%, 10%, 15% and 20% in five groups. The preparation steps of this embodiment are the same as those of Example 1. According to the preparation steps of Example 1, 1.5% of Carbomer-940 is evenly sprinkled on the surface of 30ml distilled water. After sufficient swelling, 5mL of Danggui Sini Decoction Concentrate is added, mixed evenly, distilled water is added to 50mL, and stirred evenly. The morphology, uniformity, ductility, viscosity, etc. of the gel are investigated when the mass percentage of glycerol is 0%, 5%, 10%, 15% and 20%. Score and obtain the data in Table 3.

[0040] Table 3:

[0041] Glycerol mass percentage (%) form Uniformity Ductility Viscosity total 0 3 2 2 1 8 5 3 3 2 1 9 10 3 3 3 1 10 15 3 3 2 1 9 20 3 2 2 1 8

[0042] According to the results in Table 3, when the mass percentage of glycerol is 10%, the obtained gel has the best performance, is gel-like in shape, fine and uniform, spreads evenly, and has low viscosity; when the mass percentage of glycerol is 5%, the obtained gel is gel-like, fine and uniform, spreads evenly, has a small amount that cannot be spread, and has low viscosity; when the mass percentage of glycerol is 15%, the obtained gel is gel-like, fine and uniform, spreads evenly, has a small amount that cannot be spread, and has low viscosity; when the mass percentage of glycerol is 0%, the obtained gel is gel-like in shape, has a small amount of particles, spreads evenly, has a small amount of particles, and has low viscosity; when the mass percentage of glycerol is 20%, the obtained gel is gel-like in shape, fine and uniform, spreads evenly, has poor viscosity, and is basically non-sticky. Therefore, in the orthogonal experiment of Example 4, three levels of glycerol mass percentages of 5%, 10%, and 15% will be selected for testing. The results of Table 2 are plotted into a curve graph, as shown Figure 3 As shown, the horizontal axis is the mass percentage of glycerol, and the vertical axis is the total score of glycerol at different mass percentages.

[0043] Example 3

[0044] This example uses a single factor to investigate the effect of the amount of triethanolamine on the gel properties. This example is carried out at room temperature. The mass percentage of glycerol in the gel is set to 0%, 0.25%, 0.5%, 0.75% and 1%. The preparation steps of this example are the same as those of Example 1. According to the preparation steps of Example 1, 1.5% of Carbomer-940 is evenly sprinkled on the surface of 30ml of distilled water. After sufficient swelling, 5mL of Danggui Sini Decoction Concentrate is added, mixed evenly, distilled water is added to 50mL, and stirred evenly. The morphology, uniformity, ductility, viscosity, etc. of the gel are investigated when the mass percentage of glycerol is 0%, 0.25%, 0.5%, 0.75% and 1%. Score and obtain the data in Table 4.

[0045] Table 4:

[0046]

[0047]

[0048] According to the results in Table 4, when the mass percentage of triethanolamine is 0.5%, the obtained gel has the best performance, the morphology is gel-like, delicate and uniform, the smear is uniform, the viscosity is moderate, and the pH value is 4.6; when the mass percentage of triethanolamine is 0.25%, the obtained gel has better performance, the morphology is gel-like, delicate and uniform, the smear is uniform, the viscosity is moderate, and the pH value is 3.8; when the mass percentage of triethanolamine is 0.75%, the obtained gel has better performance, the morphology is gel-like, delicate and uniform, the smear is uniform, the viscosity is moderate, and the pH value is 5. The H value is 5.4; when the mass percentage of triethanolamine is 1%, the obtained gel has general performance, a semi-solid shape, fine and uniform, evenly applied, high viscosity, and a pH value of 7.0; when the mass percentage of triethanolamine is 0%, the obtained gel has poor performance, a gel-like shape, fine and uniform, evenly applied, a small amount of which cannot be applied, poor viscosity, basically non-sticky, and a pH value of 3.0; therefore, the orthogonal test of Example 4 will be conducted at three levels of triethanolamine mass percentage of 0.25%, 0.5%, and 0.75%. The results of Table 3 are plotted as a curve, as shown in FIG. Figure 4 As shown, the horizontal axis is the mass percentage of triethanolamine, and the vertical axis is the total score of triethanolamine at different mass percentages.

[0049] Example 4

[0050] In order to determine the dosage of each reagent, the comprehensive score of the gel is used as the evaluation standard. This embodiment conducts a 3-factor 3-level orthogonal test to determine the influence of the dosage of carbomer-940, glycerol, and triethanolamine on the performance of the gel, and selects the optimal prescription ratio. The preferred dosages of Examples 1 to 3 are selected, that is, the mass percentage of carbomer-940: 1%, 1.5%, 2%, the mass percentage of glycerol: 5%, 10%, 15%, and the mass percentage of triethanolamine: 0.25%, 0.5%, 0.75%, to form different test groups, prepare gels, observe the morphology, uniformity, ductility, viscosity, heat resistance, cold resistance stability and centrifugal stability of the prepared gel, collect the scoring data and use statistical software for data processing, and determine the optimal level of each factor according to the orthogonal test results. The evaluation indexes are shown in Table 5.

[0051] Table 5:

[0052]

[0053] The evaluation indicators in Table 5 are specifically tested according to the following methods:

[0054] Appearance: The sample hydrogel is uniform, fine, and remains gelatinous at room temperature without drying up or liquefaction and without lumps.

[0055] pH: Take 1 mL of the hydrogel sample and add 20 mL of distilled water to dilute it evenly. Use pH test paper to measure it. After leaving it for 30 seconds to stabilize, use a colorimetric card for colorimetry.

[0056] Heat resistance test: Place the prepared gel in a 55℃ water bath for 2 hours and then take it out. After returning to room temperature, observe whether the gel has stratification and color change.

[0057] Cold resistance test: Place the gel in a -20℃ refrigerator for 72 hours. After returning to room temperature, observe whether the gel has stratification and color change.

[0058] Centrifugation test: Take 10g of the prepared gel into a centrifuge tube, place the centrifuge tube in a centrifuge, centrifuge at 3000r / min for 30min, then take it out and observe whether the gel has stratification and color change.

[0059] A three-factor three-level orthogonal experiment was designed with the mass percentage of carbomer-940 (A), the mass percentage of glycerol (B), and the mass percentage of triethanolamine (C). The mass percentage of each component is shown in Table 6.

[0060] Table 6:

[0061]

[0062] The samples obtained by the orthogonal test were tested to obtain the scores in Table 7. The score data were analyzed and processed to obtain the orthogonal test results in Table 8 and the variance analysis results in Table 9.

[0063] Table 7:

[0064] serial number form Uniform Extension Viscosity transparent Greasy Heat resistant Cold resistant Centrifugation pH Total score 1 4 4 4 3 5 3 2 3 4 5 37 2 5 5 4 4 5 5 3 4 4 2 41 3 5 5 5 4 4 3 3 4 3 3 39 4 5 5 5 4 5 3 4 4 4 2 41 5 5 5 5 5 5 5 5 5 5 5 50 6 5 5 5 5 5 3 5 5 4 5 47 7 4 4 4 4 2 3 3 3 4 5 36 8 4 4 4 4 2 5 4 4 4 3 38 9 4 4 4 4 3 3 4 4 4 2 36

[0065] Table 8:

[0066]

[0067]

[0068] Table 9:

[0069] factor Sum of Squares of Deviations Degrees of Freedom F-number Significance Carbomer-940 141.556 2 20.548 0.046 glycerin 37.556 2 5.452 0.155 Triethanolamine 8.222 2 1.194 0.456

[0070] It can be seen from the above chart that the range R of factor A is the largest, that is, when the level of factor A changes, it has the greatest impact on the test indicators. Secondly, factor B has a relatively large impact on the test indicators, and factor C has a smaller impact on the test indicators. Therefore, the amount of Carbomer-940 is the most important factor affecting the results of this test, followed by the amount of glycerol. The amount of triethanolamine has the smallest impact, that is, A>B>C.

[0071] According to the above test, the gel performance is optimal when the mass percentage of Carbomer-940 is 1.5%, the mass percentage of glycerol is 10%, and the mass percentage of triethanolamine is 0.5%.

Claims

1. A gel for treating arthritis, characterized in that: The invention comprises the following raw materials in percentage by weight: 1.0% to 2.0% of carbomer-940, 5% to 15% of glycerol, 0.25% to 0.75% of triethanolamine, 10% of Danggui Sini Tang concentrate and the remainder of distilled water; The Danggui Sini Decoction concentrate comprises the following raw materials in weight ratio: 8-10 parts of angelica, 8-10 parts of cassia twig, 8-10 parts of peony root, 2-4 parts of asarum, 5-7 parts of liquorice, 5-7 parts of tongcao and 4-6 parts of jujube.

2. The gel for treating arthritis according to claim 1, characterized in that: The mass percentage of the Carbomer-940 is 1.5%, the mass percentage of the glycerol is 10%, and the mass percentage of the triethanolamine is 0.5%.

3. A method for preparing a gel for treating arthritis according to any one of claims 1 to 2, characterized in that: The following steps are involved: S1, preparing Danggui Sini Decoction concentrated solution: weighing the raw materials of Danggui Sini Decoction concentrated solution, crushing the raw materials, soaking the crushed medicinal materials in 600 mL of distilled water for 30 minutes, heating the soaked medicinal materials together with the distilled water to boiling, keeping boiling for 30 minutes, pouring out the medicinal liquid and filtering the medicinal residue to complete the first decoction; repeating the above decoction and filtering for a total of three decoctions; combining the medicinal liquids obtained from the three decoctions and concentrating them until the volume is reduced to 120 mL; S2, preparing a gel matrix: evenly sprinkle carbomer-940 on the surface of 30 mL of distilled water, let it stand for a while to allow the carbomer-940 to swell naturally, and then stir until it is completely dissolved to obtain a carbomer-940 solution; S3, mixing the Danggui Sini Tang concentrated solution with the gel matrix: taking 5 ml of the Danggui Sini Tang concentrated solution in S1, and mixing the Danggui Sini Tang concentrated solution with glycerol; adding the mixed solution to the carbomer-940 solution, and mixing them to obtain a gel solution; S4, adjusting the pH value: adding triethanolamine to the gel solution of S3, and continuing to add distilled water to the gel solution until the total volume reaches 50 mL, thereby obtaining a gel for treating arthritis; S5, finished product inspection and packaging: test the shape, uniformity, ductility, viscosity and pH value of the gel, and pack the gel that passes the inspection into containers for sealed storage.

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