Traditional Chinese medicine patch containing pericarpium citri reticulatae and capable of relieving arthralgia and preparation method of traditional Chinese medicine patch

Abstract

The invention belongs to the technical field of medicines, and particularly relates to a pericarpium citri reticulatae-containing traditional Chinese medicine patch for relieving arthralgia and a preparation method thereof. The joint pain relieving traditional Chinese medicine patch containing the pericarpium citri reticulatae comprises traditional Chinese medicine components and a medicine carrying layer, the traditional Chinese medicine component is prepared from the following raw materials in parts by mass: 15 to 35 parts of pericarpium citri reticulatae, 10 to 25 parts of radix et rhizoma rhei, 10 to 30 parts of radix angelicae pubescentis, 1 to 15 parts of liquorice root, 10 to 25 parts of ramulus cinnamomi, 10 to 30 parts of radix gentianae macrophyllae, 25 to 40 parts of herba plantaginis, 5 to 15 parts of cortex erythrinae, 5 to 20 parts of earthworm, 1 to 10 parts of rhizoma arisaematis and 10 to 25 parts of caulis lonicerae. According to the patch disclosed by the invention, the patch with good transdermal absorption is prepared from carefully selected raw materials through a modern process, and the patch has the advantages of convenience in use, quick response, lasting relief of arthralgia and the like, and is suitable for adjuvant therapy of diseases such as rheumatoid arthritis, rheumatic arthritis, osteoarthritis and the like.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine, and particularly relates to a traditional Chinese medicine patch containing Sichuan tangerine peel for relieving joint pain and a preparation method thereof. Background Art

[0002] Knee osteoarthritis is a common clinical bone and joint disease, characterized by swelling, pain, and decreased motor function. Further progression can lead to knee dysfunction and even disability. According to Traditional Chinese Medicine (TCM), this condition is often classified as a "bi syndrome" or "wei syndrome," and its pathogenesis is closely related to liver and kidney deficiency, insufficient Qi and blood, Qi stagnation and blood stasis, and internal dampness. Qi stagnation and blood stasis, and spleen deficiency and dampness obstruction are among the most common clinical syndromes.

[0003] Currently, treatments for knee osteoarthritis primarily include oral medications (such as nonsteroidal anti-inflammatory drugs, glucocorticoids, and traditional Chinese medicine preparations), physical therapy, acupuncture and massage, and surgery. However, long-term use of chemical medications can easily cause side effects such as gastrointestinal discomfort and liver and kidney damage, while surgical treatment is invasive and expensive, making it difficult for patients to accept. Therefore, developing safe, effective, and easy-to-use topical treatments has become a key research focus. Current patch products on the market generally suffer from inaccurate formulations and poor efficacy. In particular, they lack specificity for specific syndromes such as qi stagnation and blood stasis, and spleen deficiency and dampness obstruction, limiting their further clinical application.

[0004] Chinese patent CN115531505B discloses a traditional Chinese medicine gel plaster for anti-inflammatory and analgesic treatment of osteoarthritis and a preparation method thereof. The traditional Chinese medicine composition comprises 15-18 parts of Vitex rotundifolia seeds, 15-18 parts of Bauhinia bark, 3-5 parts of Angelica sinensis, 3-5 parts of Papaya, 3-5 parts of Salvia miltiorrhiza, 3-5 parts of Paeonia lactiflora, 3-5 parts of Angelica dahurica, 3-5 parts of Curcuma longa, 3-5 parts of Duhuo angelicae pubescens, 3-5 parts of Notopterygium wilfordii, 3-5 parts of Radix Trichosanthis, 3-5 parts of Cyathulae chinensis, 3-5 parts of Clematidis root, 3-5 parts of Stephania tetrandra, 3-5 parts of Saposhnikovia divaricata, 3-5 parts of Nux vomica, 2-3 parts of Ligusticum chuanxiong, 2-3 parts of Gentiana macrophylla, 2-3 parts of Forsythia suspensa, and 1-2 parts of Licorice.

[0005] In the existing technology, most traditional Chinese medicine components for treating osteoarthritis have complex raw material formulas and require alcohol extraction to achieve ideal results. However, the alcohol extraction process has higher production costs. If the ethanol recovery process is complicated, there will be pollution and waste problems if it is not recovered. Summary of the Invention

[0006] The invention aims to provide a traditional Chinese medicine patch containing Sichuan dried tangerine peel for relieving joint pain and a preparation method thereof.

[0007] In order to achieve the above object, the present invention provides the following technical solutions: A traditional Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel comprises a traditional Chinese medicine component and a drug-carrying layer; the traditional Chinese medicine component comprises the following raw materials in parts by weight: 15-35 parts of Sichuan dried orange peel, 10-25 parts of rhubarb, 10-30 parts of angelica dahurica, 1-15 parts of liquorice, 10-25 parts of cassia twig, 10-30 parts of gentiana macrophylla, 25-40 parts of plantain, 5-15 parts of pittosporum tobira bark, 5-20 parts of earthworm, 1-10 parts of arisaema, and 10-25 parts of honeysuckle vine.

[0008] Preferably, the Chinese medicine components include the following raw materials in parts by mass: 22-30 parts of Sichuan tangerine peel, 14-20 parts of rhubarb, 12-24 parts of angelica dahurica, 5-10 parts of licorice, 15-25 parts of cinnamon twig, 19-29 parts of gentiana macrophylla, 28-35 parts of plantain, 8-14 parts of pittosporum bark, 11-16 parts of earthworm, 3-9 parts of arisaema, and 16-24 parts of honeysuckle vine.

[0009] Preferably, the Chinese medicine components include the following raw materials in parts by mass: 26 parts of Sichuan dried tangerine peel, 15 parts of rhubarb, 22 parts of angelica dahurica, 7 parts of licorice, 17 parts of cinnamon twig, 27 parts of gentiana macrophylla, 32 parts of plantain, 12 parts of pittosporum bark, 14 parts of earthworm, 6 parts of arisaema, and 20 parts of honeysuckle vine.

[0010] The present invention also provides a method for preparing the Chinese medicinal patch for relieving joint pain containing Sichuan dried orange peel, comprising the following steps: (1) The raw materials of the Chinese medicinal components are mixed and then crushed to obtain a mixed raw material, and the mixed material is subjected to CO2 supercritical extraction to collect volatile oil and extract respectively; (2) Add water to the extract, soak at room temperature, heat under reflux for extraction, and combine the extracts to obtain a mixed solution; (3) The mixed solution is concentrated under reduced pressure and then mixed evenly with volatile oil to obtain the Chinese medicine components; (4) The Chinese medicine components are coated on the drug-carrying layer to obtain a Chinese medicine patch for relieving joint pain containing Sichuan dried tangerine peel.

[0011] Preferably, the conditions for CO2 supercritical extraction are: extraction pressure 30-35 MPa, extraction temperature 40-50°C, and extraction time 1-2 h.

[0012] Preferably, 12-15 times the volume of water is added to the extract.

[0013] Preferably, the soaking condition at room temperature is: soaking at 25-30°C for 12-18 hours.

[0014] Preferably, the conditions for heating reflux extraction are: 2-3 hours each time, and repeated extraction 2-4 times.

[0015] Preferably, the mixture is concentrated under reduced pressure to a relative density of 1.15 to 1.20.

[0016] Preferably, the raw materials of the traditional Chinese medicine components are mixed and then crushed to less than 40 mesh.

[0017] The drug-carrying layer of the present invention can be made of materials commonly used in the prior art, and is specifically made by adsorbing tourmaline powder onto a polylactic acid drug-carrying nanofiber membrane through electrostatic adsorption, followed by pressing and cutting.

[0018] The drug combination used in the present invention follows the theory of "monarch, minister, assistant and envoy" in traditional Chinese medicine, with rigorous prescription and reasonable compatibility. The whole prescription uses plantain and gentian as monarch, and the two have synergistic properties and meridians, and are good at clearing away heat and dampness, unblocking meridians and relieving pain, and are good at treating damp-heat obstruction, joint swelling and pain, and meridian stagnation; Sichuan tangerine peel and angelica dahurica are ministers, among which Sichuan tangerine peel regulates qi and strengthens the spleen, dries dampness and resolves phlegm, and angelica dahurica dispels wind and dampness, dispels cold and relieves pain, and together help the monarch drug to dispel rheumatism, dredge meridians, and regulate the middle jiao; rhubarb, cinnamon twig, earthworm, and honeysuckle are used as adjuvants, rhubarb clears the bowels and relieves heat, promotes blood circulation and removes blood stasis, and cinnamon twig warms the meridians and dispels cold, and helps yang and transform Qi, earthworms dredge meridians and relieve pain, clear away heat and stop wind, honeysuckle vine clears heat and detoxifies, relieves wind and dredges meridians, together playing the effects of promoting blood circulation and menstruation, dispelling wind and dampness, clearing heat and relieving pain; Pittosporum bark, Arisaema and licorice are the messengers, Pittosporum bark dispels wind and dampness, relaxes muscles and activates meridians, Arisaema dries dampness and resolves phlegm, dispels wind and stops spasms, licorice harmonizes all the medicines, relieves urgency and stops pain, the three together can enhance the effect of dispelling wind and resolving phlegm, relaxing muscles and activating meridians, and can also coordinate the rise and fall of cold and heat in the whole prescription, making its overall effect tend to be balanced.

[0019] All raw materials are prepared in accordance with the standards of the Chinese Pharmacopoeia and meet clinical medication standards. As this formulation is for external use, combined with traditional usage experience, it is highly safe and well-tolerated, and has excellent anti-inflammatory, analgesic, and blood circulation-activating effects. Therefore, it has broad application prospects in the development of external preparations for the treatment of rheumatic pain, bone injuries, swelling, and pain, among other conditions.

[0020] Compared with the prior art, the advantages and beneficial effects of the present invention are: 1. The patch of the present invention is made of carefully selected raw materials and is made into a patch with good transdermal absorption through modern technology. The patch has the advantages of being easy to use, fast-acting, and lastingly relieving joint pain. It is suitable for the adjuvant treatment of diseases such as rheumatoid arthritis, rheumatic arthritis, and osteoarthritis.

[0021] 2. To address the complex composition of existing Chinese medicines, the present invention proposes a simplified and efficient patch formulation. By carefully selecting targeted Chinese medicinal materials and formulating them according to the Traditional Chinese Medicine theory of "monarch, minister, assistant and envoy," this ensures that each medicinal material can achieve its maximum effectiveness while avoiding unnecessary ingredient additions. It is specifically targeted at treating knee osteoarthritis caused by qi stagnation and blood stasis and spleen deficiency and dampness obstruction. Compared with traditional treatments, the patch of the present invention is not only more concise in formulation but also more effective in efficacy.

[0022] 3. Unlike traditional alcohol extraction methods, the present invention uses advanced supercritical carbon dioxide extraction followed by water extraction to achieve efficient extraction of active ingredients. These methods not only better retain the active ingredients in the medicinal materials, but also reduce solvent residues, improving product purity and safety. The preparation process of the present invention does not use alcohol extraction, which can significantly reduce energy consumption and pollution emissions during the production process, in line with the development trend of green pharmaceutical manufacturing. DETAILED DESCRIPTION

[0023] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0024] The raw materials used in the following examples of the present invention are all commercially available commodities: Tourmaline powder, Hebei Hengyue Mineral Products Co., Ltd., particle size 1500 mesh.

[0025] Example 1 This embodiment provides a Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel, comprising a Chinese medicine component and a drug-carrying layer; the Chinese medicine component comprises the following raw materials in parts by weight: 26 parts of Sichuan dried orange peel, 15 parts of rhubarb, 22 parts of angelica dahurica, 7 parts of licorice, 17 parts of cassia twig, 27 parts of gentiana macrophylla, 32 parts of plantain, 12 parts of pittosporum tobira bark, 14 parts of earthworm, 6 parts of arisaema, and 20 parts of honeysuckle vine.

[0026] The preparation method of the Chinese medicinal patch containing Sichuan dried tangerine peel for relieving joint pain comprises the following steps: (1) The raw materials of the Chinese medicinal components were mixed and crushed to less than 40 mesh to obtain a mixed raw material, and the mixed material was subjected to CO2 supercritical extraction at an extraction pressure of 32 MPa, an extraction temperature of 45°C, and an extraction time of 1.5 h. The volatile oil and the extract were collected separately; (2) Add 13 times the volume of water to the extract, soak at room temperature for 15 hours, heat under reflux for 3 hours, repeat the extraction three times, and combine the extracts to obtain a mixed solution; (3) The mixed solution was concentrated under reduced pressure to a relative density of 1.18, and volatile oil was added and mixed evenly to obtain the Chinese medicine component; (4) Tourmaline powder was adsorbed onto a polylactic acid drug-loaded nanofiber membrane (Qiyue Biological) by electrostatic adsorption (electrostatic adsorption voltage of 32 kV, current of 25 μA, temperature of 45 °C, and humidity of 65%). The thickness of the tourmaline powder adsorption was 1 mm. The drug-loaded layer was obtained by pressing and cutting. The Chinese medicine component was coated on the side of the drug-loaded layer with tourmaline powder. The drug loading amount accounted for 20 wt % of the tourmaline powder. A Chinese medicine patch for relieving joint pain containing Sichuan tangerine peel was obtained.

[0027] Example 2 This embodiment provides a Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel, comprising a Chinese medicine component and a drug-carrying layer; the Chinese medicine component comprises the following raw materials in parts by weight: 22 parts of Sichuan dried orange peel, 20 parts of rhubarb, 12 parts of angelica dahurica, 10 parts of licorice, 15 parts of cassia twig, 29 parts of gentiana macrophylla, 28 parts of plantain, 14 parts of pittosporum tobira bark, 11 parts of earthworm, 9 parts of arisaema, and 16 parts of honeysuckle vine.

[0028] The preparation method of the Chinese medicinal patch containing Sichuan dried tangerine peel for relieving joint pain comprises the following steps: (1) The raw materials of the Chinese medicinal components were mixed and crushed to less than 40 mesh to obtain a mixed raw material, and the mixed material was subjected to CO2 supercritical extraction at an extraction pressure of 30 MPa, an extraction temperature of 50°C, and an extraction time of 1 h. The volatile oil and the extract were collected separately; (2) Add 15 times the volume of water to the extract, soak at room temperature for 12 hours, heat under reflux for 3 hours, repeat the extraction twice, and combine the extracts to obtain a mixed solution; (3) The mixed solution is concentrated under reduced pressure to a relative density of 1.20, and volatile oil is added and mixed evenly to obtain the Chinese medicine component; (4) Tourmaline powder was adsorbed onto a polylactic acid drug-loaded nanofiber membrane (Qiyue Bio) by electrostatic adsorption (electrostatic adsorption voltage of 32 kV, current of 25 μA, temperature of 45 °C, and humidity of 65%) with a thickness of 1 mm. The drug-loaded layer was obtained by pressing and cutting. The Chinese medicine component was coated on the side of the drug-loaded layer with tourmaline powder. The drug loading amount accounted for 20 wt % of the tourmaline powder. A Chinese medicine patch for relieving joint pain containing Sichuan tangerine peel was obtained.

[0029] Example 3 This embodiment provides a Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel, comprising a Chinese medicine component and a drug-carrying layer; the Chinese medicine component comprises the following raw materials in parts by weight: 30 parts of Sichuan dried orange peel, 14 parts of rhubarb, 24 parts of angelica dahurica, 5 parts of licorice, 25 parts of cassia twig, 19 parts of gentiana macrophylla, 35 parts of plantain, 8 parts of pittosporum tobira bark, 16 parts of earthworm, 3 parts of arisaema, and 24 parts of honeysuckle vine.

[0030] The preparation method of the Chinese medicinal patch containing Sichuan dried tangerine peel for relieving joint pain comprises the following steps: (1) The raw materials of the Chinese medicinal components were mixed and crushed to less than 40 mesh to obtain a mixed raw material, and the mixed material was subjected to CO2 supercritical extraction at an extraction pressure of 35 MPa, an extraction temperature of 40°C, and an extraction time of 2 h. The volatile oil and the extract were collected separately; (2) Add 12 times the volume of water to the extract, soak at room temperature for 18 hours, heat under reflux for 2 hours, repeat the extraction 4 times, and combine the extracts to obtain a mixed solution; (3) The mixed solution is concentrated under reduced pressure to a relative density of 1.15, and volatile oil is added and mixed uniformly to obtain the Chinese medicine component; (4) Tourmaline powder was adsorbed onto a polylactic acid drug-loaded nanofiber membrane (Qiyue Bio) by electrostatic adsorption (electrostatic adsorption voltage of 32 kV, current of 25 μA, temperature of 45 °C, and humidity of 65%) with a thickness of 1 mm. The drug-loaded layer was obtained by pressing and cutting. The Chinese medicine component was coated on the side of the drug-loaded layer with tourmaline powder. The drug loading amount accounted for 20 wt % of the tourmaline powder. A Chinese medicine patch for relieving joint pain containing Sichuan tangerine peel was obtained.

[0031] Comparative Example 1 The difference between this comparative example and Example 1 is that the Chinese medicine components include the following raw materials in parts by mass: 12 parts of Sichuan tangerine peel, 30 parts of rhubarb, 7 parts of angelica dahurica, 20 parts of licorice, 5 parts of cinnamon twig, 36 parts of gentiana macrophylla, 20 parts of plantain, 25 parts of pittosporum tobira bark, 30 parts of earthworm, 15 parts of arisaema, and 3 parts of honeysuckle vine.

[0032] Comparative Example 2 The difference between this comparative example and Example 1 is that the Chinese medicine components include the following raw materials in parts by mass: 40 parts of Sichuan tangerine peel, 4 parts of rhubarb, 32 parts of angelica dahurica, 25 parts of licorice, 36 parts of cinnamon twig, 5 parts of gentiana macrophylla, 45 parts of plantain, 20 parts of pittosporum tobira bark, 3 parts of earthworm, 12 parts of arisaema, and 30 parts of honeysuckle vine.

[0033] Comparative Example 3 The difference between this comparative example and Example 1 is that the bark of Pittosporum tobira is replaced by the bark of Bauhinia chinensis.

[0034] Comparative Example 4 The difference between this comparative example and Example 1 is that cinnamon twig is replaced by Scutellaria baicalensis.

[0035] Comparative Example 5 The difference between this comparative example and Example 1 is that the total amount of Pittosporum tobira bark and cassia twig in the raw materials of the Chinese medicinal components remains unchanged, but the ratio is changed.

[0036] The traditional Chinese medicine components include the following raw materials in parts by weight: 26 parts of Sichuan dried tangerine peel, 15 parts of rhubarb, 22 parts of angelica dahurica, 7 parts of liquorice, 7 parts of cassia twig, 27 parts of gentiana macrophylla, 32 parts of plantain, 22 parts of pittosporum tobira bark, 14 parts of earthworm, 6 parts of arisaema, and 20 parts of honeysuckle vine.

[0037] Comparative Example 6 The total amount of Pittosporum tobira bark and cassia twig in the raw materials of the traditional Chinese medicine components remains unchanged, but the proportion is changed.

[0038] The traditional Chinese medicine components include the following raw materials in parts by weight: 26 parts of Sichuan dried tangerine peel, 15 parts of rhubarb, 22 parts of angelica dahurica, 7 parts of liquorice, 26 parts of cassia twig, 27 parts of gentiana macrophylla, 32 parts of plantain, 3 parts of pittosporum tobira bark, 14 parts of earthworm, 6 parts of arisaema, and 20 parts of honeysuckle vine.

[0039] Comparative Example 7 The difference between this comparative example and Example 1 is that the preparation method of the Chinese medicine patch for relieving joint pain containing Sichuan dried tangerine peel comprises the following steps: (1) Mixing the raw materials of the Chinese medicinal components and crushing them to a size smaller than 40 mesh to obtain a mixed raw material; (2) Add 13 times the volume of 80% ethanol aqueous solution to the mixed raw materials, heat and reflux to extract for 3 hours, repeat the extraction 3 times, and combine the extracts to obtain a mixed solution; (3) The mixed solution is concentrated under reduced pressure to a relative density of 1.18 to obtain the Chinese medicine component; (4) Tourmaline powder was adsorbed onto a polylactic acid drug-loaded nanofiber membrane (Qiyue Bio) by electrostatic adsorption (electrostatic adsorption voltage of 32 kV, current of 25 μA, temperature of 45 °C, and humidity of 65%) with a thickness of 1 mm. The drug-loaded layer was obtained by pressing and cutting. The Chinese medicine component was coated on the side of the drug-loaded layer with tourmaline powder. The drug loading amount accounted for 20 wt % of the tourmaline powder. A Chinese medicine patch for relieving joint pain containing Sichuan tangerine peel was obtained.

[0040] Comparative Example 8 The difference between this comparative example and Example 1 is that the preparation method of the Chinese medicine patch for relieving joint pain containing Sichuan dried tangerine peel comprises the following steps: (1) The raw materials of the Chinese medicinal components are mixed and crushed to less than 40 mesh to obtain a mixed raw material. 13 times the volume of water is added to the mixed raw material, first soaked at room temperature for 15 hours, heated under reflux for extraction for 3 hours, and the extraction is repeated 3 times. The extracts are combined to obtain a mixed solution, and the extraction residue is collected; (2) The extracted residue was subjected to supercritical CO2 extraction at an extraction pressure of 32 MPa, an extraction temperature of 45°C, and an extraction time of 1.5 h, and the volatile oil was collected; (3) The mixed solution was concentrated under reduced pressure to a relative density of 1.18, and volatile oil was added and mixed evenly to obtain the Chinese medicine component; (4) Tourmaline powder was adsorbed onto a polylactic acid drug-loaded nanofiber membrane (Qiyue Bio) by electrostatic adsorption (electrostatic adsorption voltage of 32 kV, current of 25 μA, temperature of 45 °C, and humidity of 65%) with a thickness of 1 mm. The drug-loaded layer was obtained by pressing and cutting. The Chinese medicine component was coated on the side of the drug-loaded layer with tourmaline powder. The drug loading amount accounted for 20 wt % of the tourmaline powder. A Chinese medicine patch for relieving joint pain containing Sichuan tangerine peel was obtained.

[0041] Comparative Example 9 This comparative example is Wantong Muscle and Bone Patch (Tonghua Wantong Pharmaceutical Co., Ltd., JICA Registration No. 20212090153).

[0042] Performance Testing (1) Establishment of a rat knee osteoarthritis model: Healthy Wistar rats were anesthetized with chloral hydrate injection and the knee joint was disinfected. An incision was made on the medial side of the left parapatellar to expose the knee joint. The joint capsule was incised, the joint cavity was opened, and the medial and lateral patellar dislocation was performed. The knee joint was flexed to expose the anterior cruciate ligament, which was then cut. A drawer test was then performed to confirm anterior cruciate ligament rupture. Hemostasis was performed, the patella was repositioned, and the incision was closed layer by layer. Penicillin 400,000 μ was then injected intramuscularly once daily for 3 consecutive days.

[0043] Rats were randomly divided into 8 groups. Experimental group: Each model rat was treated with a Chinese medicine patch once a day for 8 hours each time for 7 consecutive days. Model group: 8 model rats were treated with a blank patch. Blank group: 8 healthy rats were selected.

[0044] (2) Hot and cold plate pain test: Hot plate method: The rats were placed on a (55±0.5)°C hot plate, and the time from the start of the experiment to the first licking of the hind paw was used as the pain response index. The pain threshold (seconds) was also recorded.

[0045] Cold plate method: Rats were placed on a cold plate at (4±0.5)°C. The time from the start of the experiment to the first lick of the hind paw was used as the pain response indicator. The pain threshold (seconds) was recorded. Each rat was tested three times, and the average value for each group was calculated.

[0046] The results are shown in Table 1.

[0047] Table 1 Results of pain threshold test in rats Hot plate method, s Cold plate method, s Blank group 10.5±2.8 42.5±10.4 Model Group 11.3±3.7 34.8±8.6 Example 1 23.1±2.3 80.1±7.1 Example 2 22.8±4.9 78.6±9.8 Example 3 22.4±2.4 76.7±5.7 Comparative Example 1 17.2±2.7 64.0±5.0 Comparative Example 2 17.6±4.5 63.8±9.2 Comparative Example 3 19.2±3.1 68.1±6.1 Comparative Example 4 19.7±4.6 67.4±6.7 Comparative Example 5 20.3±4.0 68.9±7.3 Comparative Example 6 20.9±3.5 69.4±9.0 Comparative Example 7 17.8±2.8 64.3±8.4 Comparative Example 8 18.1±3.6 65.5±7.6 Comparative Example 9 18.9±2.9 66.1±6.5 As shown in Table 1, the patches of Examples 1-3 have better therapeutic effects than the commercially available products.

[0048] In Comparative Examples 1 and 2, the raw material composition is changed, and the therapeutic effect decreases, indicating that the raw material used in the Chinese medicine components of the present invention can only play a good therapeutic effect under a specific ratio. In Comparative Examples 3-6, Pittosporum tobira bark, cassia twig or the two ratios are not used at the same time, and the therapeutic effect decreases, indicating that Pittosporum tobira bark and cassia twig have a synergistic effect in the prescription of the present invention. Only by adding these two raw materials at the same time can the therapeutic effect of the patch be significantly improved. In Comparative Example 7, the method of using alcohol extraction is used to prepare the patch, and the preparation method of using CO2 supercritical extraction after water extraction is used in Comparative Example 8. The therapeutic effect is worse than that of Example 1, indicating that the raw material of the present invention has a better extraction effect using the corresponding preparation method.

[0049] Application Examples The volunteers in the control group and the observation group were all patients with knee osteoarthritis of qi stagnation and blood stasis, spleen deficiency and dampness obstruction type who received conservative treatment.

[0050] There were 5 cases in the control group, including 3 males and 2 females; their ages ranged from 35 to 62 years, with an average of (48.12±9.86) years; their disease duration ranged from 2 to 7 years, with an average of (4.76±2.18) years; and their lesion sites were on the left side in 2 cases and on the right side in 3 cases.

[0051] There were 5 cases in the observation group, including 3 males and 2 females; their ages ranged from 39 to 68 years, with an average of (53.85±8.61) years; their disease duration ranged from 2 to 7 years, with an average of (4.91±2.14) years; and their lesion sites were on the left side in 3 cases and on the right side in 2 cases.

[0052] There was no statistically significant difference in the baseline data between the two groups (P>0.05), indicating that the two groups were balanced and comparable.

[0053] 1. Observation group: Each group was treated with oral celecoxib capsules (Pfizer, 0.2g / pill, orally after meals, 1 capsule once a day) + Chinese medicine patches for 6 weeks.

[0054] 2. Control group: Each group was given celecoxib capsules (Pfizer, 0.2 g / capsule, orally after meals, 1 capsule once a day) for 6 weeks.

[0055] The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) was used to assess symptoms before and after the intervention. The WOMAC includes pain (5 items), stiffness (2 items), and difficulty in daily activities (17 items). Each item is scored from 0 to 4, with higher scores indicating more severe symptoms. The total score ranges from 0 to 96, with higher scores indicating more severe symptoms. (For details, see the article: Clinical Value of Quantitative Assessment of Knee Osteoarthritis Using 3.0T Magnetic Resonance T2× Mapping Imaging and Correlation Analysis with WOMAC Score.) The results are shown in Table 2.

[0056] Table 2 Symptom severity in the two groups (WOMAC score) Before intervention After intervention P-value Observation Group 62.16±4.87 21.96±3.27 <0.05 control group 62.23±4.91 35.83±4.05 <0.05 P-value 0.845 <0.05 / The results showed that before the intervention, there was no statistically significant difference in the WOMAC scores between the two groups (P>0.05); after the intervention, the WOMAC scores of the two groups were lower than before the intervention, and the observation group was lower than the control group, and the differences were statistically significant (P<0.05).

[0057] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel, characterized in that: The invention comprises traditional Chinese medicine components and a drug-carrying layer; the traditional Chinese medicine components comprise the following raw materials in parts by weight: 15-35 parts of Sichuan dried orange peel, 10-25 parts of rhubarb, 10-30 parts of angelica dahurica, 1-15 parts of liquorice, 10-25 parts of cassia twig, 10-30 parts of gentiana macrophylla, 25-40 parts of plantain, 5-15 parts of pittosporum tobira bark, 5-20 parts of earthworm, 1-10 parts of arisaema, and 10-25 parts of honeysuckle vine.

2. The Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel according to claim 1, characterized in that, The traditional Chinese medicine components include the following raw materials in parts by weight: 22-30 parts of Sichuan dried tangerine peel, 14-20 parts of rhubarb, 12-24 parts of angelica dahurica, 5-10 parts of liquorice, 15-25 parts of cassia twig, 19-29 parts of gentiana macrophylla, 28-35 parts of plantain, 8-14 parts of pittosporum tobira bark, 11-16 parts of earthworm, 3-9 parts of arisaema, and 16-24 parts of honeysuckle vine.

3. The Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel according to claim 2, characterized in that, The traditional Chinese medicine components include the following raw materials in parts by weight: 26 parts of Sichuan dried tangerine peel, 15 parts of rhubarb, 22 parts of angelica dahurica, 7 parts of liquorice, 17 parts of cassia twig, 27 parts of gentiana macrophylla, 32 parts of plantain, 12 parts of pittosporum tobira bark, 14 parts of earthworm, 6 parts of arisaema, and 20 parts of honeysuckle vine.

4. The method for preparing the Chinese medicinal patch for relieving joint pain containing Sichuan dried orange peel according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) The raw materials of the Chinese medicinal components are mixed and then crushed to obtain a mixed raw material, and the mixed material is subjected to CO2 supercritical extraction to collect volatile oil and extract respectively; (2) Add water to the extract, soak at room temperature, heat under reflux for extraction, and combine the extracts to obtain a mixed solution; (3) The mixed solution is concentrated under reduced pressure and then mixed evenly with volatile oil to obtain the Chinese medicine components; (4) The Chinese medicine components are coated on the drug-carrying layer to obtain a Chinese medicine patch for relieving joint pain containing Sichuan dried tangerine peel.

5. The method for preparing the Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel according to claim 3, wherein: The conditions for CO2 supercritical extraction in step (1) are: extraction pressure 30-35 MPa, extraction temperature 40-50°C, and extraction time 1-2 h.

6. The method for preparing the Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel according to claim 4, wherein: In the step (1), 12-15 times the volume of water is added to the extract.

7. The method for preparing the Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel according to claim 4, wherein: The condition of soaking at room temperature in step (2) is: soaking at 25-30°C for 12-18 hours.

8. The method for preparing the Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel according to claim 4, wherein: The conditions for the heating reflux extraction in step (2) are: 2-3 hours each time, and the extraction is repeated 2-4 times.

9. The method for preparing the Chinese medicine patch for relieving joint pain containing Sichuan dried orange peel according to claim 4, wherein: In the step (3), the reduced pressure concentration is performed until the relative density is 1.15-1.

20.

10. The method for preparing the Chinese medicinal patch for relieving joint pain containing Sichuan dried orange peel according to claim 4, wherein: In the step (1), the raw materials of the Chinese medicinal components are mixed and then crushed to less than 40 meshes.