A plaster for treating joint pain and a method for preparing the same

CN120514775BActive Publication Date: 2026-09-18ZHUHAI HOSPITAL OF INTEGRATED TRADITIONAL CHINESE & WESTERN MEDICINE (ZHUHAI SECOND PEOPLES HOSPITAL)
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Patent Information

Application Number
CN202511034387.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-07-25
Publication Date
2026-09-18
Estimated Expiration
2045-07-25

AI Technical Summary

Technical Problem

[0004]本申请实施例通过提供一种治疗关节疼痛的药膏及其制备方法,解决了现有技术中,脂水双溶成分难以兼容,干湿环境导致脱落的问题,实现了更好的成分组合和长时间作用的效果

Benefits of technology

[0021] Through a three-tiered technology of "carrier modification - functional coating - biomimetic adhesion", transdermal enzymes are used to precisely open skin channels; mussel protein forms a pH/humidity responsive gel in the presence of iron ions; eggshell powder is utilized as waste, and ethanol/water-based spraying reduces organic solvent residue; ultimately, a modern Chinese medicine joint pain relief ointment with high penetration, strong adhesion, and sustained-release effect is obtained.

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Abstract

This application discloses a medicated ointment for treating joint pain and its preparation method, relating to the field of traditional Chinese medicine preparation technology. The main ingredients include: Epimedium: 30-50 parts, Tripterygium wilfordii: 20-40 parts, Sinapis alba: 20-50 parts, Gardenia jasminoides: 7-16 parts, Rheum palmatum: 15-20 parts, Borneol: 5-10 parts, Pueraria lobata: 10-30 parts, Achyranthes bidentata: 10-30 parts, Zanthoxylum bungeanum: 10-30 parts, Notopterygium incisum: 10-30 parts, Clematis chinensis: 10-20 parts, Atractylodes lancea: 10-20 parts, Salvia miltiorrhiza: 10-20 parts, Asarum heterotropoides: 10-20 parts, Aconitum carmichaelii: 5-15 parts, Artemisia argyi: 5-15 parts. This solution advances the application of traditional Chinese medicine external preparations from "passive application" to "intelligent response dynamic drug delivery," providing a revolutionary solution, especially for diseases requiring long-term drug delivery such as osteoarthritis and sports injuries.
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Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and in particular to a medicated ointment for treating joint pain and its preparation method. Background Technology

[0002] Closed bone injuries and fractures refer to the disruption of the integrity and continuity of the skeleton caused by external trauma. Soft tissue injuries are usually minor and are often accompanied by bone crepitus or groaning, leading to local pain, bruising, and swelling. Severe multiple fractures can even lead to shock and endanger life. Musculoskeletal and soft tissue sprains and contusions refer to injuries to muscles, tendons, joints, fascia, and other tissues caused by external forces, accompanied by bone destruction. They typically manifest as local swelling, bruising, and pain.

[0003] Currently, commonly used blood-activating and swelling-reducing powders are mainly applied as gel ointments, which contain plant or animal oils and are combined with various medicinal components to form a gel-like substance. When used, they are applied to the injured area to exert their medicinal effects. However, when conventional ointments are applied to the affected area, the ointment comes into direct contact with the outside world and is easily scratched by external objects. Furthermore, it is easy for it to fall off, whether it is dry skin or washed away by sweat during exercise. The oil-water dual-soluble components are also difficult to be compatible. Summary of the Invention

[0004] This application provides a medicated ointment for treating joint pain and its preparation method, which solves the problems in the prior art where the fat-water co-soluble components are difficult to be compatible and the dry and wet environments cause the components to fall off, thus achieving a better combination of ingredients and a longer-lasting effect.

[0005] This application provides a medicated ointment for treating joint pain, comprising an active ingredient, excipients, and a base material;

[0006] The main ingredients, by weight, include: Epimedium 30-50 parts, Tripterygium wilfordii 20-40 parts, Sinapis alba 20-50 parts, Gardenia jasminoides 7-16 parts, Rheum palmatum 15-20 parts, Borneol 5-10 parts, Pueraria lobata 10-30 parts, Achyranthes bidentata 10-30 parts, Zanthoxylum bungeanum 10-30 parts, Notopterygium incisum 10-30 parts, Clematis chinensis 10-20 parts, Atractylodes lancea 10-20 parts, Salvia miltiorrhiza 10-20 parts, Asarum sieboldii 10-20 parts, Aconitum carmichaelii 5-15 parts, Artemisia argyi 5-15 parts.

[0007] The excipients, by weight, include: 2-5 parts eggshell powder, 0.5-1.2 parts sericin peptide, 150-250 U / g sericin peptide of hyaluronidase, 4-6 wt% mussel adhesive protein of total sericin, and 0.05-0.1 mmol / L ferric chloride based on ferric ions.

[0008] The base material, by weight, includes: 6-9 parts of oxidized modified starch, 35-45 parts of kaolin, 5-10 parts of aloe vera extract, 1-3 parts of alginate, 8-15 parts of citric acid, and 60-80 parts of purified water.

[0009] The preparation method of the above-mentioned ointment for treating joint pain includes the following specific steps:

[0010] S1. Grind the Chinese medicinal materials separately and pass them through an 80-mesh sieve. Stir them in a mixer for 30 minutes until uniform using an equal-volume incremental method. Add the mixed powder and 50% ethanol solution into an extraction tank and extract at 60°C for 2 hours under an extraction pressure of 0.15 MPa. Concentrate the extract under vacuum to a specific gravity of 1.25 and remove macromolecular impurities by ultrafiltration to obtain a concentrated extract of Chinese medicinal materials.

[0011] S2. Fresh eggshells are pulverized using airflow until D90 < 15 micrometers;

[0012] S3, sericin peptide solution is atomized and loaded onto eggshell particles to make an excipient;

[0013] S4, oxidized modified starch, kaolin, aloe vera extract, alginate and purified water are stirred at 400 rpm for 15 minutes at 40°C. The concentrated extract of traditional Chinese medicine is added to the substrate and stirred at low speed at 45°C for 30 minutes. Then the excipients are added to the drug-loaded substrate and mixed at 300 rpm for 20 minutes at 45°C. Borneol is added and the pH is adjusted to 5.3 with citric acid to obtain the ointment.

[0014] Furthermore, the ethanol solution of sericin peptides, the ethanol solution of sericin peptides, and mussel adhesion proteins and Fe... 3+ The mass ratio of sericin peptides in the sericin peptide solution is 1:1.5:3.

[0015] Furthermore, fresh eggshells are pretreated by soaking them in 5% citric acid for 20 minutes to remove the inner membrane, rinsing them with pure water until neutral, and drying them at 120℃ for 2 hours.

[0016] Further, the described sericin peptides include a 5% sericin peptide ethanol solution, a 5% sericin peptide ethanol solution, mussel adhesion protein, and Fe. 3+ Sericin peptide solution.

[0017] Furthermore, a 5% silk protein peptide ethanol solution was sprayed onto the surface of eggshell powder using a pneumatic atomizer and cured at 45°C for 8 minutes to form a 0.2-micron film.

[0018] Furthermore, an aqueous solution of sericin peptide containing hyaluronidase was sprayed under a 1.0 MPa atomization pressure and cured for 10 minutes at 37°C and 60% humidity, resulting in a thickness of 0.3 micrometers.

[0019] Furthermore, mussel adhesive proteins and Fe 3+The sericin peptide solution was ultrasonically atomized into 8-micron droplets to cover the surface, and crosslinked at 37°C for 20 minutes to form a 0.3-micron adhesion layer.

[0020] One or more technical solutions provided in the embodiments of this application have at least the following technical effects or advantages:

[0021] Through a three-tiered technology of "carrier modification - functional coating - biomimetic adhesion", transdermal enzymes are used to precisely open skin channels; mussel protein forms a pH / humidity responsive gel in the presence of iron ions; eggshell powder is utilized as waste, and ethanol / water-based spraying reduces organic solvent residue; ultimately, a modern Chinese medicine joint pain relief ointment with high penetration, strong adhesion, and sustained-release effect is obtained. Detailed Implementation

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains; the terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to limit the invention; the term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0023] Example 1: A medicated ointment for treating joint pain includes an active ingredient, excipients, and a base material;

[0024] The main ingredients, by weight, include: Epimedium 30-50 parts, Tripterygium wilfordii 20-40 parts, Sinapis alba 20-50 parts, Gardenia jasminoides 7-16 parts, Rheum palmatum 15-20 parts, Borneol 5-10 parts, Pueraria lobata 10-30 parts, Achyranthes bidentata 10-30 parts, Zanthoxylum bungeanum 10-30 parts, Notopterygium incisum 10-30 parts, Clematis chinensis 10-20 parts, Atractylodes lancea 10-20 parts, Salvia miltiorrhiza 10-20 parts, Asarum sieboldii 10-20 parts, Aconitum carmichaelii 5-15 parts, Artemisia argyi 5-15 parts.

[0025] The excipients by weight include: 2-5 parts eggshell powder, 0.5-1.2 parts sericin peptide, 150-250 U / g sericin peptide hyaluronidase, 4-6 wt% mussel adhesive protein (accounting for the total sericin), and 0.05-0.1 mmol / L ferric chloride (calculated as ferric ions).

[0026] The base material, by weight, includes: 6-9 parts of oxidized modified starch, 35-45 parts of kaolin, 5-10 parts of aloe vera extract, 1-3 parts of alginate, 8-15 parts of citric acid, and 60-80 parts of purified water.

[0027] Oxidized modified starch is obtained by grinding corn starch through a 100-mesh sieve, dispersing it in purified water, adding 15% potassium permanganate solution (0.01 mol / L), stirring at 60°C for 15 minutes, then adding malic acid and polyvinyl alcohol and reacting for 40 minutes, then adding polydextrose and hydroxyethyl cellulose and stirring for 2 hours.

[0028] The mass ratio of corn starch, malic acid and polyvinyl alcohol is 1:0.5:0.6; the mass ratio of corn starch, polydextrose and hydroxyethyl cellulose is 1:0.3:0.5.

[0029] The preparation method of the above-mentioned ointment for treating joint pain includes the following specific steps:

[0030] S1. Grind the Chinese medicinal materials separately and pass them through an 80-mesh sieve. Stir them in a mixer for 30 minutes until uniform using an equal-volume incremental method. Add the mixed powder and 50% ethanol solution (material-liquid ratio 1:8) into an extraction tank. Circulate and extract at 60℃ for 2 hours at an extraction pressure of 0.15 MPa. Concentrate the extract under vacuum to a specific gravity of 1.25 (measured at 60℃). Remove macromolecular impurities by ultrafiltration to obtain a concentrated extract of Chinese medicinal materials.

[0031] S2. Fresh eggshells are soaked in 5% citric acid for 20 minutes to remove the inner membrane, rinsed with pure water until neutral, dried at 120℃ for 2 hours, and air-jet pulverized to D90 < 15 microns.

[0032] S3. Using a 5% sericin peptide ethanol solution, sprayed onto the surface of eggshell powder using a pneumatic atomizer (0.8 MPa pressure), cured at 45°C for 8 minutes to form a 0.2-micron film; using a sericin peptide aqueous solution containing hyaluronidase, sprayed at 1.0 MPa atomization pressure, cured at 37°C and 60% humidity for 10 minutes to a thickness of 0.3 microns; using mussel adhesive protein and Fe... 3+ The sericin peptide solution was ultrasonically atomized (120 kHz) into 8-micron droplets to cover the surface, and cross-linked at 37°C for 20 minutes to form a 0.3-micron adhesion layer, thus making an excipient;

[0033] Sericin peptide ethanol solution, sericin peptide ethanol solution and mussel adhesion protein and Fe 3+ The mass ratio of sericin peptides in the sericin peptide solution is 1:1.5:3;

[0034] S4, oxidized modified starch, kaolin, aloe vera extract, alginate and purified water are stirred at 400 rpm for 15 minutes at 40°C. The concentrated extract of traditional Chinese medicine is added to the substrate and stirred at low speed (200 rpm) at 45°C for 30 minutes. Then the excipients are added to the drug-loaded substrate and mixed at 300 rpm at 45°C for 20 minutes. Borneol is added and the pH is adjusted to 5.3 with citric acid to obtain the ointment.

[0035] The technical solutions described in the embodiments of this application have at least the following technical effects or advantages:

[0036] Traditional Chinese medicine covers the core pathological aspects of joint pain, including anti-inflammatory effects (Tripterygium wilfordii, raw Gardenia jasminoides), analgesia (Asarum heterotropoides, raw Aconitum carmichaelii), blood circulation promotion and meridian unblocking (Salvia miltiorrhiza, Achyranthes bidentata), and wind and dampness dispelling (Notopterygium incisum, Atractylodes lancea). When dealing with the main components, such as lipid-soluble Tripterygium wilfordii and borneol, and water-soluble components like Pueraria lobata, the eggshell powder pores are adsorbed and encapsulated with sericin peptides. Puerarin, geniposide, etc., are bound within the micropores (10-100nm) of the eggshell powder and released through a controlled release via the sericin membrane. The layered structure of kaolin intercalates Tripterygium wilfordii A, borneol, etc. The kaolin-siloxane sheets (1.2 nm interlayer spacing) prevent separation from the aqueous matrix. Facing the amphiphilic components, the oxidatively modified starch-grafted polymer microdomains (malic acid / PVA / polydextrose) construct hydrophilic-hydrophobic microdomains (20-50 nm in size), simultaneously dissolving amphiphilic molecules such as tanshinone. This allows for the simultaneous loading of both hydrophilic and hydrophobic drugs, enabling them to exert their effects and be released uniformly. This prevents the highly toxic Aconitum carmichaelii from reaching excessively high drug concentrations due to sudden release, thus avoiding toxicity.

[0037] Eggshell powder provides a porous calcium-based carrier, increasing the specific surface area, enhancing drug loading capacity, and increasing the adsorption area of ​​aconitine, reducing the possibility of burst release. Furthermore, a sericin peptide coating acts as a "molecular glue" to encapsulate the eggshell powder, allowing for the continuous release of calcium through hydrolysis. 2+ As a calcium source for alginate crosslinking, it extends the lifespan of the gel network; it can also dynamically regulate pH, decomposing to produce calcium ions in an acidic environment and maintaining the pH at 5.2-5.5 (the optimal activity window of alginate).

[0038] Sericin peptide coating: As a "molecular glue", it encapsulates eggshell powder to achieve sustained release, control the drug release rate, and avoid burst release; sericin peptides naturally promote cell adhesion, reduce local irritation, and provide a basis for subsequent enzyme / adhesion protein modification.

[0039] By employing a layered design, the enzymatic hydrolysis layer degrades the stratum corneum barrier in real time, gradually expanding drug channels. A 5% sericin peptide ethanol solution rapidly forms a film (0.2μm), sealing the pores on the eggshell powder surface to prevent drug leakage, thus solving the problems of poor powder flowability and uneven drug adsorption, and improving drug loading stability. A sericin peptide aqueous solution containing hyaluronidase enzymatically hydrolyzes hyaluronic acid in the skin, temporarily loosening the stratum corneum barrier, increasing the penetration efficiency of large molecular components such as *Clematis chinensis* and *Salvia miltiorrhiza* by more than 50%, allowing them to reach deep tissues. Mussel adhesion protein + Fe... 3+ Crosslinking agent, biomimetic wet adhesion, Fe 3+ It catalyzes the cross-linking of catechol groups, maintaining strong adhesion for 12 hours even in sweaty environments during joint activity, thus solving the problem of traditional plasters easily falling off.

[0040] Mussel adhesive proteins are rich in catechol groups, and in Fe 3+Oxidative cross-linking occurs under catalysis, forming a high-strength network structure; the adhesion strength of the cross-linked network increases in sweat / tissue fluid environments (traditional oily matrix detaches upon contact with water); ultrasonically atomized droplets penetrate into the skin texture, forming physical anchoring (resisting scratching), Fe 3+ Reversible coordination bonds temporarily dissociate and recombine during joint movement, preventing rigid detachment.

[0041] The third layer of mussel protein increases its cross-linking density when exposed to Na+ in sweat. Alginic acid forms a hydrated gel layer under high humidity, which not only does not wash away and become ineffective in a sweaty environment but also further binds itself. The β-sheet structure of sericin peptides shrinks under low humidity, enhancing electrostatic adsorption with the stratum corneum. The polysaccharides in aloe vera extract provide continuous moisturizing and still have a good adsorption effect in dry skin conditions.

[0042] Experimental designs were conducted for the aforementioned ointment, including formulation suitability experiments and mechanism of action experiments. The suitability experiments included adhesion retention rate testing, puerarin transdermal absorption rate testing, and component uniformity testing. The adhesion retention rate testing method involved uniformly applying 50 mg of the ointment to isolated pig skin (2 × 2 cm). 2 The surface of the sample (1.5 mm thick) was incubated at 37°C with a relative humidity of 90%. Artificial sweat (ISO 3160-2 standard formula) was sprayed at 1 mL every 30 minutes. The sample was then fixed in a reciprocating friction instrument (amplitude ±30°, frequency 1 Hz, simulating knee flexion and extension). The initial mass (W0) and the residual mass (W1) after 12 hours were weighed. Adhesion retention rate = (W1 / W0) × 100%. Artificial sweat formula: NaCl 0.5%, urea 0.1%, lactic acid 0.1%, pH 5.5.

[0043] The transdermal transdermal absorption rate of puerarin was tested using the Franz diffusion cell method. The method involved: isolated porcine ear skin (thickness 0.8±0.1 mm), with the fat layer removed, and the integrity was verified (TEWL value < 10 g·m³). -2 ·h -1 );

[0044] Supply tank: Contains 20mg of ointment (effective diffusion area 1.77cm²) 2 ); Receiving cell: PBS (containing 30% PEG400, magnetically stirred at 37℃); Sampling and analysis: Take 0.5 mL of the receiving solution after 24 hours (and replenish with an equal volume of fresh solution).

[0045] HPLC detection conditions: Puerarin: mobile phase: methanol-water (30:70), C18 column, detection wavelength: 250 nm;

[0046] For the component uniformity test, five tubes of the same batch of ointment were taken, and samples were taken from three parts (top, middle, and bottom) of each tube. The content was determined by HPLC, and the relative standard deviation (RSD) was calculated. CV% = (standard deviation / average value) × 100% (uniformity test method)

[0047] The baseline formula consisted of 40 parts Epimedium, 30 parts Tripterygium wilfordii, 35 parts Sinapis alba, 10 parts Gardenia jasminoides, 18 parts Rheum palmatum, 8 parts Borneol, 20 parts Pueraria lobata, 20 parts Achyranthes bidentata, 20 parts Zanthoxylum bungeanum, 20 parts Notopterygium incisum, 15 parts Clematis chinensis, 15 parts Atractylodes lancea, 15 parts Salvia miltiorrhiza, 15 parts Asarum heterotropoides, 10 parts Aconitum carmichaelii, and 10 parts Artemisia argyi; 3 parts eggshell powder, 1 part sericin peptide, 200 U / g sericin peptide hyaluronidase, 5 wt% mussel adhesive protein (as a percentage of total sericin), 1 mmol / L ferric chloride (calculated as ferric ions); 8 parts oxidized modified starch, 40 parts kaolin, 7 parts aloe vera extract, 2 parts alginate, 10 parts citric acid, and 70 parts purified water. The experimental groups were adjusted based on this formula, with each experimental group maintaining the same formula ratios as the baseline formula except for adjustments. The adaptability test groups are shown in Table 1.

[0048] Table 1 Adaptability Test Groups

[0049] A1 Epimedium 30 parts + Tripterygium wilfordii 20 parts 2 parts eggshell powder + 0.5 parts sericin peptide 6 parts oxidized modified starch + 60 parts water A2 Epimedium 50 parts + White Mustard Seed 50 parts 5 parts eggshell powder + 1.2 parts sericin peptide 9 parts oxidized modified starch + 80 parts water A3 5 parts raw aconite + 5 parts borneol Hyaluronidase 150U / g 1 part alginate + 8 parts citric acid A4 15 parts raw aconite root + 10 parts borneol Hyaluronidase 250U / g 3 parts alginate + 15 parts citric acid A5 10 parts of Salvia miltiorrhiza + 10 parts of Asarum heterotropoides <![CDATA[mussel protein 4wt% + Fe 3+ 0.05mmol]]> 35 portions of kaolin A6 20 parts of Salvia miltiorrhiza + 20 parts of Asarum heterotropoides <![CDATA[mussel protein 6 wt% + Fe 3+ 0.1 mmol]]> 45 portions of kaolin

[0050] The results are shown in Table 2;

[0051] Table 2 Results of the Adaptability Experiment

[0052] A1 83.50% 42.7 8.20% A2 86.10% 45.9 7.80% A3 84.20% 38.5 9.10% A4 87.30% 47.2 6.90% A5 82.80% 41.3 8.70% A6 88.60% 49.1 5.40%

[0053] Mechanism of action experiments include adhesion and retention experiments, skin barrier disruption depth, lipophilic component release rate, and water soluble component penetration rate.

[0054] The skin barrier disruption depth assay was performed using confocal microscopy. 0.1% FITC-glucan (molecular weight 4 kDa) was added to the ointment. After application to ex vivo skin, the skin was incubated at 37°C for 8 hours. Frozen sections (10 μm thick) were then prepared, and the Z-axis was scanned using a laser confocal microscope (488 nm excitation). The barrier disruption depth was defined as the skin depth at which fluorescence intensity decayed to 50%.

[0055] The extraction rate experiment for lipid-soluble components was conducted as follows: the ointment was placed in a centrifuge tube and stored at a constant temperature of 40℃ for 28 days. After centrifugation at 3000g for 15 minutes, the oil droplets precipitated on the surface were collected. The precipitate was dissolved in toluene, and the content of triptolide was determined by HPLC. The extraction rate was calculated as (amount of precipitated drug / total amount of drug) × 100%.

[0056] The permeation rate experiment for water-soluble components was conducted using a Franz diffusion cell (same as the transdermal measurement). The cumulative permeation (Q) was linearly regressed against time (t), and the permeation rate was calculated as the steady-state slope (μg·cm⁻¹).-2 ·h -1 );

[0057] The experimental groups are shown in Table 3;

[0058] Table 3 Experimental grouping of mechanism of action

[0059] B1 Complete technical solution (three-layer spraying + substrate optimization) Standard process B2 Remove hyaluronidase layer The second coating was replaced with pure silk peptide. B3 Remove the mussel's adhesive protein layer <![CDATA[No adhesion protein in the third layer / Fe 3+ > B4 Unmodified substrate (ordinary starch + no alginate) Eliminating the oxidation modification step in the substrate B5 Commercially available plant oil gels Contains 15% tea seed oil base B6 Blank substrate Drug-free / Functional excipient-free

[0060] The results are shown in Table 4;

[0061] Table 4. Experimental results of mechanism of action

[0062] B1 91.3% 38.5±2.1 2.1% Puerarin: 1.82 / Tanshinone: 0.93 B2 89.7% 18.2±3.4↓ 3.5% Puerarin: 0.97↓ / Tanshinone: 0.88 B3 52.4%↓ 36.8±1.9 2.8% Puerarin: 1.75 / Tanshinone: 0.90 B4 76.2%↓ 29.1±2.8↓ 15.3%↑ Puerarin: 1.21↓ / Tanshinone: 0.61↓ B5 41.2%↓ 22.7±2.5↓ 8.9%↑ Puerarin: 0.53↓ / Tanshinone: 0.72 B6 32.8%↓ 0 (Not damaged) - -

[0063] It should be noted that "↓" indicates a significant decrease compared to group B1, with a decrease of at least 20%, while "↑" indicates a significant increase, with an increase of at least 100%.

[0064] Example 2: The method of using the above ointment is as follows: Clean the affected skin, apply a warm water compress for 5 minutes, and apply every 10cm... 2 Apply 0.5g of ointment (about the size of a pea) evenly to the affected area, forming a thin layer of 0.3mm.

[0065] After applying the medicine, let it sit for 30 minutes, then gently press the surface of the ointment for 10 seconds. If the ointment has been used for more than 8 hours, slowly peel it off along the skin texture. You can wipe it with olive oil to dissolve it and then wash it with warm water.

[0066] The ointment should be stored at a temperature not exceeding 25°C and with a humidity of less than 60%. It should be protected from light and used at intervals of more than 8 hours. Once exposed to air (after opening), it should be used within 60 days. Shake well if water is released.

[0067] The technical solutions described in the embodiments of this application have at least the following technical effects or advantages:

[0068] Because the monthly enzyme activity decay rate is >15% at temperatures above 25℃, it should be stored at low temperatures and gently pressed (greater than 0.1 N / cm). 2 It can initiate the cross-linking reaction of mussel proteins, allowing the ointment to take effect, but it cannot be applied to broken skin (due to the irritation of the enzymatic components) or used repeatedly to avoid overloading the enzyme activity.

[0069] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. For those skilled in the art, the present invention can have various modifications and variations. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A medicated ointment for treating joint pain, characterized in that, Including active pharmaceutical ingredient, excipients, and base materials; The main ingredients, by weight, include: Epimedium 30-50 parts, Tripterygium wilfordii 20-40 parts, Sinapis alba 20-50 parts, Gardenia jasminoides 7-16 parts, Rheum palmatum 15-20 parts, Borneol 5-10 parts, Pueraria lobata 10-30 parts, Achyranthes bidentata 10-30 parts, Zanthoxylum bungeanum 10-30 parts, Notopterygium incisum 10-30 parts, Clematis chinensis 10-20 parts, Atractylodes lancea 10-20 parts, Salvia miltiorrhiza 10-20 parts, Asarum sieboldii 10-20 parts, Aconitum carmichaelii 5-15 parts, Artemisia argyi 5-15 parts. The excipients, by weight, include: 2-5 parts eggshell powder, 0.5-1.2 parts sericin peptide, each gram of sericin peptide contains 150-250U of hyaluronidase, mussel adhesin accounts for 4-6wt% of the total sericin peptide, and 0.05-0.1mmol / L of ferric chloride based on ferric ions. The base material, by weight, includes: 6-9 parts of oxidized modified starch, 35-45 parts of kaolin, 5-10 parts of aloe vera extract, 1-3 parts of alginate, 8-15 parts of citric acid, and 60-80 parts of purified water.

2. The method for preparing a medicated ointment for treating joint pain as described in claim 1, characterized in that, The specific steps include: S1. Grind the Chinese medicinal materials separately and pass them through an 80-mesh sieve. Stir them in a mixer for 30 minutes until uniform using an equal-volume incremental method. Add the mixed powder and 50% ethanol solution into an extraction tank and extract at 60°C for 2 hours under an extraction pressure of 0.15 MPa. Concentrate the extract under vacuum to a specific gravity of 1.25 and remove macromolecular impurities by ultrafiltration to obtain a concentrated extract of Chinese medicinal materials. S2. Fresh eggshells are pulverized using airflow until D90 < 15 micrometers; S3, sericin peptides are loaded onto eggshell powder through atomization to form an excipient; S4, oxidized modified starch, kaolin, aloe vera extract, alginate and purified water are stirred at 400 rpm for 15 minutes at 40°C. The concentrated extract of traditional Chinese medicine is added to the substrate and stirred at low speed at 45°C for 30 minutes. Then the excipients are added to the drug-loaded substrate and mixed at 300 rpm for 20 minutes at 45°C. Borneol is added and the pH is adjusted to 5.3 with citric acid to obtain the ointment.

3. The method for preparing a medicated ointment for treating joint pain as described in claim 2, characterized in that, Fresh eggshells are pretreated by soaking them in 5% citric acid for 20 minutes to remove the inner membrane, rinsing them with pure water until neutral, and drying them at 120℃ for 2 hours.

4. The method for preparing a medicated ointment for treating joint pain as described in claim 2, characterized in that, The specific preparation method of the excipients is as follows: A 5% sericin peptide ethanol solution is sprayed onto the surface of eggshell powder using a pneumatic atomizer and cured at 45°C for 8 minutes to form a 0.2-micron film; a sericin peptide aqueous solution containing hyaluronidase is sprayed at a 1.0 MPa atomization pressure and cured at 37°C and 60% humidity for 10 minutes to a thickness of 0.3 microns; mussel adhesive protein and Fe... 3+ The sericin peptide solution was ultrasonically atomized into 8-micron droplets to cover the surface, and crosslinked at 37°C for 20 minutes to form a 0.3-micron adhesion layer.

Citation Information

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