Traditional Chinese medicine compound beeswax thermal therapy medicine penetration product as well as preparation and application thereof

Abstract

The invention discloses a traditional Chinese medicine compound beewax thermal therapy transdermal drug product as well as preparation and application thereof, and belongs to the technical field of external treatment of traditional Chinese medicines. The product is composed of 70%-90% of natural beeswax and 10%-30% of a traditional Chinese medicine compound, and the traditional Chinese medicine compound is selected from medicines for promoting blood circulation to remove blood stasis, dispelling wind and eliminating dampness and the like according to indications; the preparation method comprises the steps of traditional Chinese medicine pretreatment, beewax melting, medicine mixing and forming. During application, treatment is completed through medicinal wax heating, skin pretreatment, medicinal wax application, treatment maintenance and subsequent treatment. The physical effect of beeswax thermal therapy and the pharmacological effect of traditional Chinese medicine are synergistically combined, the continuous thermal effect of beeswax can promote blood circulation, improve the transdermal efficiency of the medicine and enhance the activity of the medicine, and the curative effect is remarkable; the natural beewax is good in biocompatibility, gastrointestinal tract stimulation and the first-pass effect of the liver are avoided through transdermal drug delivery, and the safety is high; the medicine is standardized in preparation, simple and convenient to operate, suitable for primary medicine and families, capable of treating various diseases such as painful diseases and soft tissue injury and high in clinical application value.

Description

Technical Field

[0001] This invention relates to the field of external treatment technology of traditional Chinese medicine, specifically to a traditional Chinese medicine compound beeswax heat therapy transdermal product and its preparation method and application, which is particularly suitable for the treatment and rehabilitation of painful diseases, soft tissue injuries, cold and dampness diseases and some chronic skin diseases. Background Technology

[0002] In traditional Chinese medicine clinical treatment, external therapies have been widely used because they can directly act on the lesion site and avoid the gastrointestinal irritation and first-pass effect of oral medications. Heat therapy, as an important form of external therapy, achieves pain relief by promoting local blood circulation and relieving muscle spasms. However, traditional heat therapy methods (such as hot water bottle application and infrared irradiation) have drawbacks such as short heat duration and limited effectiveness, making it difficult to maximize therapeutic efficacy.

[0003] Meanwhile, although transdermal drug delivery technology for traditional Chinese medicine can deliver drugs directly to the lesion, conventional transdermal preparations (such as plasters and patches) often suffer from problems such as low skin barrier penetration efficiency, uneven drug release rate, and slow therapeutic effect. In addition, existing products combining thermotherapy and transdermal drug delivery are mostly chemically synthesized matrices with poor biocompatibility, which can easily cause skin allergies. Furthermore, their indications are narrow, and the operation procedures are complex, making them difficult to popularize in primary healthcare institutions and homes.

[0004] Beeswax, as a natural biomaterial, possesses advantages such as high heat capacity, low thermal conductivity, and good biocompatibility, and has been initially applied in the field of thermotherapy. However, existing beeswax thermotherapy products are mostly simple beeswax products, without incorporating the pharmacological effects of traditional Chinese medicine compound formulas, thus failing to achieve synergistic effects between thermotherapy and drug therapy. Furthermore, their preparation processes lack standardization, and key parameters such as drug addition ratios and heating temperatures are not clearly regulated, leading to unstable product efficacy and unreliable safety. Therefore, developing a topical product that combines the dual effects of thermotherapy and transdermal drug delivery of traditional Chinese medicine, with standardized preparation, simple operation, and high safety, has become an urgent need in the current field of external treatment with traditional Chinese medicine. Summary of the Invention

[0005] In view of the shortcomings of existing thermotherapy products, such as limited efficacy, low transdermal efficiency of traditional Chinese medicine, non-standardized preparation process, poor safety and complicated operation, this invention provides a traditional Chinese medicine compound beeswax thermotherapy transdermal drug delivery product and its preparation and application method. This product organically combines the physical effects of beeswax thermotherapy with the pharmacological effects of traditional Chinese medicine compound to achieve synergistic effect. At the same time, it has the advantages of standardized preparation, simple operation, high safety and wide range of indications, which can meet the needs of primary healthcare and home rehabilitation.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] The herbal compound beeswax thermotherapy transdermal medicine product is composed of a natural beeswax matrix and a herbal compound. The mass ratio of each component is: 70%-90% natural beeswax and 10%-30% herbal compound. The purity of the natural beeswax is ≥95%. The herbal compound is one or more of the following: blood-activating and stasis-removing drugs, wind-dispelling and dampness-removing drugs, and cold-dispersing and pain-relieving drugs.

[0008] Furthermore, the blood-activating and stasis-removing drugs include one or more of the following: chuanxiong, safflower, angelica, danshen, red peony root, frankincense, and myrrh; the wind-dispelling and dampness-removing drugs include one or more of the following: angelica pubescens, notopterygium incisum, saposhnikovia divaricata, and atractylodes lancea; and the cold-dispersing and pain-relieving drugs include one or more of the following: mugwort leaf, cinnamon twig, and dried ginger.

[0009] The preparation method of a traditional Chinese medicine compound beeswax thermotherapy transdermal drug product includes the following steps:

[0010] Pretreatment of Traditional Chinese Medicine Compound:

[0011] The raw materials of traditional Chinese medicine are pulverized into powder of 80-120 mesh, or the extract of traditional Chinese medicine is prepared by ethanol reflux extraction, dried and pulverized into powder; the ethanol reflux extraction conditions are: ethanol concentration 60%-80%, material-liquid ratio 1:10-1:20, reflux temperature 70-85℃, reflux time 1-3h, and after extraction, the extract is filtered and concentrated to an extract with a relative density of 1.1-1.3;

[0012] Melting beeswax:

[0013] Place the natural beeswax in a constant temperature heating device and heat it to melt at a temperature of 100-120℃. Keep it warm and stir for 10-20 minutes to remove impurities.

[0014] Drug mixing:

[0015] Add the pretreated Chinese herbal compound powder to the beeswax melt and stir at 300-500 r / min for 15-30 min until it is evenly mixed.

[0016] Molded and ready for use:

[0017] Pour the well-mixed molten medicinal wax into a container or wax mold, allow it to cool naturally to room temperature and solidify to obtain a product blank or shaped medicinal wax cake, and seal it for storage.

[0018] The application method of traditional Chinese medicine compound beeswax heat therapy transdermal medicine products includes the following steps:

[0019] Heating of medicinal wax: Place the product in a constant temperature heater and heat it to 55-65℃. After melting, maintain a uniform temperature.

[0020] Skin pretreatment: Wash the skin in the treatment area with warm water at 30-40℃, dry it, and then perform an allergy test. If there is no allergic reaction, it can be used for future use.

[0021] Application of medicated wax: Apply the medicated wax to the treatment area using either a smearing or plastering method. The smearing method involves using a sterile brush or scraper to evenly apply the medicated wax to the treatment area to a thickness of 0.5-1 cm, then covering it with a plastic film for insulation. The plastering method involves pouring the medicated wax into a wax mold and cooling it to 45-50°C to form a wax cake, which is then applied to the treatment area and fixed in place.

[0022] Treatment and maintenance: Maintain the temperature of the treatment area at 40-50℃, each treatment lasts 30-60 minutes, 2-3 times a week, and 5-10 treatments constitute one course of treatment;

[0023] Follow-up care: After treatment, wait for the wax to solidify and then remove it. Wash the skin with warm water and keep the treated area clean and dry for 2 hours.

[0024] Furthermore, the allergy test method is as follows: apply a small amount of melted medicated wax to a skin area with a diameter of 2-3 cm near the treatment site, cover with sterile gauze, and observe for 20-30 minutes. If there is no allergic reaction such as redness, swelling, or itching, treatment can proceed.

[0025] Furthermore, the product is suitable for the treatment of painful diseases, soft tissue injuries, cold-dampness syndromes, and chronic skin diseases; the painful diseases include cervical spondylosis, frozen shoulder, lumbar disc herniation, arthritis, rheumatoid arthritis, and osteoarthritis; the soft tissue injuries include sprains, strains, contusions, and muscle strain; the cold-dampness syndromes include colds, cold-type stomach pain, abdominal pain, diarrhea, irregular menstruation, and dysmenorrhea; the chronic skin diseases include neurodermatitis and psoriasis.

[0026] Compared with the prior art, the present invention has the following significant advantages:

[0027] 1. Significant therapeutic effect and synergistic enhancement: This invention organically combines the physical effects of beeswax thermotherapy with the pharmacological effects of traditional Chinese medicine compound. The continuous heat effect of beeswax can dilate local blood vessels, promote blood circulation, and open skin pores, significantly improving the transdermal efficiency of traditional Chinese medicine components. At the same time, thermotherapy can enhance the activity of traditional Chinese medicine components, making it easier for the drug to enter the interstitial space and blood circulation. This dual action on the lesion site greatly enhances the therapeutic effect, especially for chronic pain, soft tissue injury and other conditions, which is more effective than single thermotherapy or single drug therapy.

[0028] 2. High safety and good biocompatibility: This invention uses natural beeswax with a purity of ≥95% as a matrix. Natural beeswax is non-toxic, has minimal skin irritation, and rarely causes allergic reactions. The drug enters the body through transdermal administration, avoiding the gastrointestinal irritation and first-pass effect of oral drugs, significantly reducing drug side effects and making it suitable for long-term treatment.

[0029] 3. Standardized preparation and controllable quality: This invention clarifies the standards for key preparation steps such as the pretreatment process of traditional Chinese medicine compound, beeswax melting temperature, drug mixing ratio and stirring parameters, ensuring the quality stability of different batches of products; at the same time, the components of traditional Chinese medicine compound can be flexibly adjusted according to the indications to achieve individualized treatment.

[0030] 4. Simple to operate and widely applicable: The preparation and application of this invention do not require complex equipment or professional technical training, and can be operated by primary medical institutions and families; it is applicable to painful diseases such as cervical spondylosis, frozen shoulder, lumbar disc herniation, and rheumatoid arthritis, soft tissue injuries such as sprains and strains, cold and damp diseases such as colds and cold-type gastrointestinal diseases, as well as chronic skin diseases such as neurodermatitis and psoriasis. It has a wide range of indications and high clinical application value. Detailed Implementation

[0031] The present invention will now be described in more detail and in a more complete manner.

[0032] The traditional Chinese medicine compound beeswax thermotherapy transdermal drug product, its preparation and application provided by this invention are characterized by:

[0033] (I) Composition of Traditional Chinese Medicine Compound Beeswax Heat Therapy Products

[0034] This product is composed of a natural beeswax matrix and a traditional Chinese medicine compound. The mass ratio of each component is as follows: natural beeswax 70%-90%, and traditional Chinese medicine compound 10%-30%. The natural beeswax is selected from high-quality natural beeswax with a purity of ≥95%, odorless and free of impurities, and has good thermal stability and adhesion. The traditional Chinese medicine compound is selected from one or more combinations of blood-activating and stasis-removing drugs, wind-dispelling and dampness-removing drugs, cold-dispersing and pain-relieving drugs, and heat-clearing and detoxifying drugs, depending on the disease being treated. Specifically, it includes but is not limited to: Ligusticum chuanxiong, safflower, Angelica sinensis, Angelica pubescens, Notopterygium incisum, Saposhnikovia divaricata, Artemisia argyi, Cinnamomum cassia, Salvia miltiorrhiza, Paeonia lactiflora, frankincense, myrrh, Atractylodes lancea, and Phellodendron chinense.

[0035] (II) Preparation method of traditional Chinese medicine compound beeswax heat therapy penetrating medicine

[0036] The preparation method of this product includes the following steps:

[0037] Pretreatment of Traditional Chinese Medicine Compound: Determine the components and proportions of the Traditional Chinese Medicine compound according to the target indication. Grind each raw material of Traditional Chinese Medicine into powder of 80-120 mesh, or prepare the extract of Traditional Chinese Medicine by ethanol reflux extraction. The ethanol reflux extraction conditions are: ethanol concentration 60%-80%, material-liquid ratio 1:10-1:20, reflux temperature 70-85℃, reflux time 1-3h. After extraction, filter and concentrate to an extract with a relative density of 1.1-1.3, dry and grind into powder for later use.

[0038] Beeswax melting: Select high-quality natural beeswax, place it in a constant temperature heating device, heat it to melt at a temperature of 100-120℃, keep it at the temperature and stir for 10-20 minutes to remove air bubbles and impurities, and obtain a clear beeswax melt.

[0039] Drug mixing: Add the pretreated Chinese herbal compound powder or extract to the beeswax melt, stir at a speed of 300-500 r / min for 15-30 min, and ensure that the drug and beeswax matrix are evenly mixed to form a homogeneous drug wax melt.

[0040] Molding and preparation: Pour the well-mixed molten medicinal wax into a clean container, let it cool naturally to room temperature, and after solidification, you will get the blank of the Chinese herbal compound beeswax heat therapy penetrating medicine product; or pour it directly into a special wax mold, cool and shape it into a medicinal wax cake of the preset shape, and seal it for later use.

[0041] (III) Application Methods of Traditional Chinese Medicine Compound Beeswax Heat Therapy Products

[0042] The application method of this product includes the following steps:

[0043] Heating of medicinal wax: Place the prepared Chinese herbal compound beeswax heat therapy product into a constant temperature heater and heat it to 55-65℃ to melt it and maintain a suitable fluidity and temperature. Stir continuously during the heating process to ensure uniform temperature.

[0044] Skin pretreatment: Select the treatment area, wash the skin with warm water at 30-40℃ to remove surface dirt, oil and stratum corneum, dry it and then perform an allergy test; the allergy test method is as follows: take a small amount of melted medicated wax and apply it to a small area of ​​skin (2-3cm in diameter) near the treatment area, cover it with sterile gauze, observe for 20-30 minutes, if there is no allergic reaction such as redness, swelling or itching, the subsequent treatment can be carried out;

[0045] Application of medicated wax: Choose one of the following two application methods depending on the size and shape of the treatment area:

[0046] Application method: Use a sterile brush or scraper to evenly apply the melted medicated wax to the treatment area, with a thickness of 0.5-1cm. After application, immediately cover with sterile plastic film, and then wrap with a cotton towel or blanket to keep warm and prevent heat loss.

[0047] Application method: Pour the melted medicated wax into a special wax mold and cool it to 45-50℃ (not hot to the touch) to form a medicated wax cake. Apply the medicated wax cake to the treatment area and fix it with medical bandages or adhesive tape to ensure that the medicated wax cake is in close contact with the skin.

[0048] Treatment and maintenance: During the treatment, skin temperature and patient response are monitored in real time to ensure that the temperature of the treatment area is maintained at 40-50℃ to avoid burns; each treatment lasts 30-60 minutes, 2-3 times a week, and 5-10 treatments constitute one course of treatment;

[0049] Follow-up care: After treatment, allow the wax to cool and solidify naturally, then gently peel it off. If a small amount of wax remains on the skin, wash it off with warm water; there is no need to use irritating cleansers. Keep the treated area clean and dry for 2 hours after treatment, and avoid exposure to cold.

[0050] The present invention will be further described in detail below with reference to the embodiments. The embodiments are only used to explain the present invention and do not constitute a limitation on the scope of protection of the present invention.

[0051] Example 1:

[0052] Traditional Chinese medicine compound beeswax thermotherapy transdermal products for promoting blood circulation and removing blood stasis and their applications

[0053] (I) Product composition: 80g of natural beeswax (80% by weight), and a traditional Chinese medicine compound (10g of Ligusticum chuanxiong, 5g of safflower, and 5g of Angelica sinensis, accounting for 20% by weight).

[0054] (II) Preparation method:

[0055] Pre-treatment of traditional Chinese medicine compound: Grind Chuanxiong, Honghua, and Danggui into 100-mesh powder and set aside;

[0056] Melting beeswax: Take 80g of natural beeswax, place it in a constant temperature heating pot, heat it to 110℃ to melt it, keep it warm and stir for 15 minutes to remove impurities;

[0057] Drug mixing: Add 20g of Chinese herbal medicine powder to the beeswax melt, stir at 400r / min for 20min, and mix evenly;

[0058] Molding and preparation: Pour the molten medicinal wax into a round wax mold (10cm in diameter), cool to room temperature to obtain a medicinal wax cake, and seal and store it.

[0059] Pre-treatment of traditional Chinese medicine compound: Grind Chuanxiong, Honghua, and Danggui into 100-mesh powder and set aside;

[0060] Melting beeswax: Take 80g of natural beeswax, place it in a constant temperature heating pot, heat it to 110℃ to melt it, keep it warm and stir for 15 minutes to remove impurities;

[0061] Drug mixing: Add 20g of Chinese herbal medicine powder to the beeswax melt, stir at 400r / min for 20min, and mix evenly;

[0062] Molding and preparation: Pour the molten medicinal wax into a round wax mold (10cm in diameter), cool to room temperature to obtain a medicinal wax cake, and seal and store it.

[0063] (III) Application Methods:

[0064] Heating the medicinal wax: Place the medicinal wax cake in a constant temperature heater and heat it to 60℃ to melt it;

[0065] Skin pretreatment: Select the painful area of ​​the lower back of the patient with lumbar disc herniation, wash with 35℃ warm water, dry and perform an allergy test. If there is no allergic reaction, it can be used for future use.

[0066] Application of medicated wax: Using the application method, pour the melted medicated wax into a wax mold, cool it to 48°C, remove the medicated wax cake, apply it to the painful area of ​​the lower back, and fix it with a medical bandage;

[0067] Treatment and maintenance: Maintain the treatment temperature at around 45℃, and the treatment time is 45 minutes. Treat 3 times a week, and 8 times constitute one course of treatment.

[0068] Follow-up care: After treatment, wait for the wax to solidify and then remove it. Wash the skin with warm water and keep the lower back warm and dry for 2 hours.

[0069] Heating the medicinal wax: Place the medicinal wax cake in a constant temperature heater and heat it to 60℃ to melt it;

[0070] Skin pretreatment: Select the painful area of ​​the lower back of the patient with lumbar disc herniation, wash with 35℃ warm water, dry and perform an allergy test. If there is no allergic reaction, it can be used for future use.

[0071] Application of medicated wax: Using the application method, pour the melted medicated wax into a wax mold, cool it to 48°C, remove the medicated wax cake, apply it to the painful area of ​​the lower back, and fix it with a medical bandage;

[0072] Treatment and maintenance: Maintain the treatment temperature at around 45℃, and the treatment time is 45 minutes. Treat 3 times a week, and 8 times constitute one course of treatment.

[0073] Follow-up care: After treatment, wait for the wax to solidify and then remove it. Wash the skin with warm water and keep the lower back warm and dry for 2 hours.

[0074] (iv) Therapeutic effects:

[0075] This example was used on 10 patients with lumbar disc herniation. After one course of treatment, 8 patients experienced significant pain relief and improved mobility, and 2 patients experienced some symptom relief. The total effective rate was 100%, with no adverse reactions such as allergies or burns.

[0076] Example 2:

[0077] Traditional Chinese medicine compound beeswax heat therapy products for dispelling wind and dampness and their applications

[0078] (I) Product composition: 75g of natural beeswax (75% by weight), and a traditional Chinese medicine compound (12g of Angelica pubescens, 8g of Notopterygium incisum, and 5g of Saposhnikovia divaricata, accounting for 25% by weight).

[0079] (II) Preparation method:

[0080] Pretreatment of Chinese herbal compound: Angelica pubescens, Notopterygium incisum and Saposhnikovia divaricata were extracted by reflux with 70% ethanol at a material-to-liquid ratio of 1:15 and refluxed at 80℃ for 2 hours. After filtration, the extract was concentrated to a relative density of 1.2, dried and pulverized into 120-mesh powder.

[0081] Melting beeswax: Take 75g of natural beeswax, heat it to 120℃ to melt it, and keep it warm while stirring for 20 minutes;

[0082] Drug mixing: Add 25g of Chinese herbal medicine powder to the beeswax melt, stir at 500r / min for 25min, and mix evenly;

[0083] Molding and preparation: Pour the molten medicinal wax into a square wax mold (8cm×12cm), let it cool and solidify, and then seal and store it.

[0084] Pretreatment of Chinese herbal compound: Angelica pubescens, Notopterygium incisum and Saposhnikovia divaricata were extracted by reflux with 70% ethanol at a material-to-liquid ratio of 1:15 and refluxed at 80℃ for 2 hours. After filtration, the extract was concentrated to a relative density of 1.2, dried and pulverized into 120-mesh powder.

[0085] Melting beeswax: Take 75g of natural beeswax, heat it to 120℃ to melt it, and keep it warm while stirring for 20 minutes;

[0086] Drug mixing: Add 25g of Chinese herbal medicine powder to the beeswax melt, stir at 500r / min for 25min, and mix evenly;

[0087] Molding and Preparing: Pour the molten medicinal wax into a square wax mold (8cm×12cm), let it cool and solidify, and then seal and store it.

[0088] (III) Application Methods:

[0089] Heating of medicinal wax: Place the medicinal wax in a constant temperature heater and heat it to 58°C to melt it;

[0090] Skin pretreatment: Select the knee joint area of ​​a patient with rheumatoid arthritis, wash with 38℃ warm water, dry and test for allergies.

[0091] Application of medicated wax: Use the smear method to apply the medicated wax evenly around the knee joint with a sterile brush, with a thickness of 0.8cm. Cover with plastic film and then wrap with a blanket to keep warm.

[0092] Treatment and maintenance: Maintain the treatment temperature at around 42℃, the treatment time is 50 minutes, and the treatment is performed twice a week. 10 treatments constitute one course of treatment.

[0093] Follow-up care: After treatment, remove the solidified wax and wash the skin with warm water;

[0094] Heating of medicinal wax: Place the medicinal wax in a constant temperature heater and heat it to 58°C to melt it;

[0095] Skin pretreatment: Select the knee joint area of ​​a patient with rheumatoid arthritis, wash with 38℃ warm water, dry and test for allergies.

[0096] Application of medicated wax: Use the smear method to apply the medicated wax evenly around the knee joint with a sterile brush, with a thickness of 0.8cm. Cover with plastic film and then wrap with a blanket to keep warm.

[0097] Treatment and maintenance: Maintain the treatment temperature at around 42℃, the treatment time is 50 minutes, and the treatment is performed twice a week. 10 treatments constitute one course of treatment.

[0098] Follow-up care: After treatment, remove the solidified wax and wash the skin with warm water.

[0099] (iv) Therapeutic effects:

[0100] This embodiment was used on 8 patients with rheumatoid arthritis. After one course of treatment, joint pain and swelling were reduced and mobility was improved in 6 patients, and symptoms were stabilized in 2 patients with no adverse reactions. The effective rate was 100%.

[0101] Example 3:

[0102] Traditional Chinese medicine compound beeswax heat therapy products for dispelling cold and relieving pain and their applications

[0103] (I) Product composition: 85g of natural beeswax (85% by weight), and a traditional Chinese medicine compound (8g of mugwort, 5g of cinnamon twig, and 2g of dried ginger, accounting for 15% by weight).

[0104] (II) Preparation method:

[0105] Pre-treatment of traditional Chinese medicine compound: Grind mugwort leaves, cinnamon twigs, and dried ginger into 80-mesh powder;

[0106] Melting beeswax: Take 85g of natural beeswax, heat to 100℃ to melt, and keep warm while stirring for 10 minutes;

[0107] Drug mixing: Add 15g of Chinese herbal medicine powder to the beeswax melt, stir at 300r / min for 15min, and mix evenly;

[0108] Molding and Preparing: Pour the molten medicinal wax into a round wax mold (8cm in diameter), let it cool and solidify, and then seal and store it.

[0109] Pre-treatment of traditional Chinese medicine compound: Grind mugwort leaves, cinnamon twigs, and dried ginger into 80-mesh powder;

[0110] Melting beeswax: Take 85g of natural beeswax, heat to 100℃ to melt, and keep warm while stirring for 10 minutes;

[0111] Drug mixing: Add 15g of Chinese herbal medicine powder to the beeswax melt, stir at 300r / min for 15min, and mix evenly;

[0112] Molding and Preparing: Pour the molten medicinal wax into a round wax mold (8cm in diameter), let it cool and solidify, and then seal and store it.

[0113] (III) Application Methods:

[0114] Heating the medicinal wax: Place the medicinal wax in a constant temperature heater and heat it to 65°C to melt it;

[0115] Skin pretreatment: The upper abdomen of patients with cold-type stomach pain was selected, washed with 32℃ warm water, dried, and an allergy test was performed.

[0116] Application of medicated wax: The molten medicated wax is cooled to 45°C and then applied to the upper abdomen and secured with adhesive tape.

[0117] Treatment and maintenance: Maintain the treatment temperature at around 40℃, and the treatment time is 30 minutes. Treat 3 times a week, and 5 times constitute one course of treatment.

[0118] Follow-up care: After treatment, remove the solidified wax and wash the skin with warm water;

[0119] Heating the medicinal wax: Place the medicinal wax in a constant temperature heater and heat it to 65°C to melt it;

[0120] Skin pretreatment: The upper abdomen of patients with cold-type stomach pain was selected, washed with 32℃ warm water, dried, and an allergy test was performed.

[0121] Application of medicated wax: The molten medicated wax is cooled to 45°C and then applied to the upper abdomen and secured with adhesive tape.

[0122] Treatment and maintenance: Maintain the treatment temperature at around 40℃, and the treatment time is 30 minutes. Treat 3 times a week, and 5 times constitute one course of treatment.

[0123] Follow-up care: After treatment, remove the solidified wax and wash the skin with warm water.

[0124] (iv) Therapeutic effects:

[0125] This embodiment was used on 6 patients with cold-type stomach pain. After one course of treatment, the stomach pain symptoms disappeared in 5 patients and the symptoms were relieved in 1 patient. There were no adverse reactions and the effectiveness rate was 100%.

[0126] To further verify the efficacy stability and safety of the present invention, the treatment data of the above three embodiments were summarized and statistically analyzed, and safety verification test data were added, as shown in the table below:

[0127] I. Summary Table of Efficacy Verification Trial Data

[0128]

[0129] II. Summary Table of Safety Verification Test Data

[0130]

[0131] Verification instructions:

[0132] 1. Criteria for judging efficacy: Significantly effective means that symptoms have completely disappeared or significantly improved; effective means that symptoms have been somewhat relieved; ineffective means that symptoms have not changed or have worsened.

[0133] 2. Safety test results show that the product of this invention is non-irritating and non-sensitizing to the skin, and has no obvious adverse reactions with long-term use, demonstrating high safety.

[0134] The total effective rate of treatment in 3.24 patients with different diseases reached 100%, proving that the product of this invention has a stable and significant therapeutic effect on a variety of indications and can effectively achieve the synergistic effect of thermotherapy and drug therapy.

[0135] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A traditional Chinese medicine compound beeswax thermotherapy transdermal drug product, characterized by: It is composed of natural beeswax matrix and traditional Chinese medicine compound, with the following mass proportions: natural beeswax 70%-90%, traditional Chinese medicine compound 10%-30%; the purity of the natural beeswax is ≥95%; the traditional Chinese medicine compound is one or more combinations of blood-activating and stasis-removing drugs, wind-dispelling and dampness-removing drugs, and cold-dispersing and pain-relieving drugs.

2. The traditional Chinese medicine compound beeswax thermotherapy transdermal drug delivery product according to claim 1, characterized in that, The blood-activating and stasis-removing drugs include one or more of the following: chuanxiong, safflower, angelica, salvia miltiorrhiza, red peony root, frankincense, and myrrh; the wind-dispelling and dampness-removing drugs include one or more of the following: angelica pubescens, notopterygium incisum, saposhnikovia divaricata, and atractylodes lancea; and the cold-dispersing and pain-relieving drugs include one or more of the following: mugwort leaf, cinnamon twig, and dried ginger.

3. The preparation method of the traditional Chinese medicine compound beeswax thermotherapy transdermal drug product according to any one of claims 1-2, characterized in that, Includes the following steps: Pretreatment of Traditional Chinese Medicine Compound: The raw materials of traditional Chinese medicine are pulverized into powder of 80-120 mesh, or the extract of traditional Chinese medicine is prepared by ethanol reflux extraction, dried and pulverized into powder; the ethanol reflux extraction conditions are: ethanol concentration 60%-80%, material-liquid ratio 1:10-1:20, reflux temperature 70-85℃, reflux time 1-3h, and after extraction, the extract is filtered and concentrated to an extract with a relative density of 1.1-1.3; Melting beeswax: Place the natural beeswax in a constant temperature heating device and heat it to melt at a temperature of 100-120℃. Keep it warm and stir for 10-20 minutes to remove impurities. Drug mixing: Add the pretreated Chinese herbal compound powder to the beeswax melt and stir at 300-500 r / min for 15-30 min until it is evenly mixed. Molded and ready for use: Pour the well-mixed molten medicinal wax into a container or wax mold, allow it to cool naturally to room temperature and solidify to obtain a product blank or shaped medicinal wax cake, and seal it for storage.

4. The method of applying the traditional Chinese medicine compound beeswax heat therapy transdermal drug product as described in any one of claims 1-2, characterized in that, Includes the following steps: Heating of medicinal wax: Place the product in a constant temperature heater and heat it to 55-65℃. After melting, maintain a uniform temperature. Skin pretreatment: Wash the skin in the treatment area with warm water at 30-40℃, dry it, and then perform an allergy test. If there is no allergic reaction, it can be used for future use. Application of medicated wax: Apply the medicated wax to the treatment area using either a smearing or plastering method. The smearing method involves using a sterile brush or scraper to evenly apply the medicated wax to the treatment area to a thickness of 0.5-1 cm, then covering it with a plastic film for insulation. The plastering method involves pouring the medicated wax into a wax mold and cooling it to 45-50°C to form a wax cake, which is then applied to the treatment area and fixed in place. Treatment and maintenance: Maintain the temperature of the treatment area at 40-50℃, each treatment lasts 30-60 minutes, 2-3 times a week, and 5-10 treatments constitute one course of treatment; Follow-up care: After treatment, wait for the wax to solidify and then remove it. Wash the skin with warm water and keep the treated area clean and dry for 2 hours.

5. The application method according to claim 4, characterized in that, The allergy test method is as follows: apply a small amount of melted medicated wax to a skin area with a diameter of 2-3 cm near the treatment site, cover with sterile gauze, and observe for 20-30 minutes. If there is no allergic reaction such as redness, swelling, or itching, treatment can proceed.

6. The application method according to claim 4, characterized in that, The product is applicable to the treatment of painful diseases, soft tissue injuries, cold-dampness syndromes, and chronic skin diseases; the painful diseases include cervical spondylosis, frozen shoulder, lumbar disc herniation, arthritis, rheumatoid arthritis, and osteoarthritis; the soft tissue injuries include sprains, strains, contusions, and muscle strain; the cold-dampness syndromes include colds, cold-type stomach pain, abdominal pain, diarrhea, irregular menstruation, and dysmenorrhea; the chronic skin diseases include neurodermatitis and psoriasis.

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