External health-care pain-removing bone-penetrating health-care patch and preparation process thereof

Abstract

This invention provides a topical health care product, a pain-relieving and bone-penetrating patch, and its preparation process, relating to the field of traditional Chinese medicine technology. The topical health care product, a pain-relieving and bone-penetrating patch, and its preparation process include the following raw materials: 70-120 parts of Impatiens balsamina, 55-100 parts of Angelica dahurica, 30-55 parts of Clematis chinensis, 30-55 parts of Ligusticum chuanxiong, and 200-500 parts of honey. The specific steps include: S1. Selecting 80 parts of Angelica dahurica and 43 parts of Ligusticum chuanxiong, and pulverizing them separately using a pulverizer to prepare fine powders for later use. This health care patch uses a scientifically formulated traditional Chinese medicine prescription. Through the synergistic effect of Impatiens balsamina, Angelica dahurica, Clematis chinensis, and Ligusticum chuanxiong, it achieves multiple effects such as promoting blood circulation, softening hardened masses, dispelling cold and dampness, and promoting blood circulation. Long-term clinical trials have shown that this product has significant therapeutic effects on osteoarthritis of the knee joint, lumbar spine and other parts of the body. It can effectively improve conditions such as bone hyperplasia, frozen shoulder, cervical spondylosis and lumbar disc herniation. At the same time, it also has significant therapeutic effects on soft tissue injuries such as acute and chronic sprains and strains, tennis elbow, golfer's elbow and lumbar muscle strain.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to an external health care product, a pain-relieving and bone-penetrating health care patch, and its preparation process. Background Technology

[0002] Osteoarthritis (such as knee arthritis and lumbar disc herniation), chronic soft tissue injuries (such as frozen shoulder and lumbar muscle strain), and intractable skin ulcers (such as leg ulcers) are extremely common in clinical practice. These conditions are characterized by long duration, high recurrence rate, and difficulty in treatment, severely impacting patients' daily activities and quality of life. These diseases not only cause persistent pain and functional impairment but are also often accompanied by psychological problems such as sleep disorders, anxiety, and depression, placing a heavy economic burden on patients' families and society.

[0003] Currently, modern medicine primarily relies on nonsteroidal anti-inflammatory drugs (NSAIDs), local injections, or surgery for intervention. While these methods can relieve pain in the short term, long-term use of NSAIDs may increase the risk of gastrointestinal bleeding by 4-5 times, and the incidence of kidney damage can be as high as 15%. Although glucocorticoid injections are fast-acting, repeated injections more than three times a year can accelerate cartilage degeneration, causing 60% of patients to experience a worsening of their condition within 5 years. Surgical treatment is highly invasive and expensive, and the revision rate after artificial joint replacement surgery is 10-15% within 10 years. None of these methods can fundamentally repair damaged bones, joints, and soft tissues, nor can they stop the progressive development of the disease.

[0004] In contrast, traditional Chinese medicine (TCM) external therapies, with their holistic approach of "treating internal diseases externally" and the principle of syndrome differentiation and treatment, deliver medication directly to the lesion through transdermal drug delivery systems. This avoids the first-pass effect and achieves high local drug concentrations. Modern pharmacokinetic studies have confirmed that high-quality topical preparations can achieve skin penetration rates of over 60%, with a duration of action lasting 12-24 hours. Clinical data shows that standardized use of TCM external therapies can reduce VAS pain scores by more than 50% in 70% of patients with osteoarthritis, with an adverse reaction rate of less than 2%. In particular, traditional formulas improved with modern pharmaceutical technology retain the multi-target and multi-pathway effects of TCM while enhancing safety and convenience through precise dosage control and sustained-release technology, making them an ideal choice for treating such chronic diseases.

[0005] However, currently available topical plasters still have significant limitations: First, some product formulas are too simple, only providing temporary pain relief without regulating local microcirculation or inhibiting osteophyte formation; second, traditional plasters often use high-temperature processing, which may destroy some active ingredients and affect bioavailability; third, some patches, due to improper matrix selection or the addition of irritating ingredients, can easily cause skin allergies, itching, or even contact dermatitis. Furthermore, for chronic skin ulcers (such as leg ulcers), conventional dressings often only promote wound healing, lacking comprehensive anti-inflammatory and tissue-regenerating effects.

[0006] To this end, we have developed a new topical health care product, the Pain Relief and Bone Penetrating Health Care Patch, and its preparation process. Summary of the Invention

[0007] (a) Technical problems to be solved

[0008] To address the shortcomings of existing technologies, this invention provides an external health care product, a pain-relieving and bone-penetrating health care patch, and its preparation process. This solves the problems of existing external plasters, such as simple formulas, low utilization rate of effective ingredients, high skin irritation, and insufficient comprehensive therapeutic functions.

[0009] (II) Technical Solution

[0010] To achieve the above objectives, this invention employs the following technical solution: 70-120 parts of Impatiens balsamina, 55-100 parts of Angelica dahurica, 30-55 parts of Clematis chinensis, 30-55 parts of Ligusticum chuanxiong, and 200-500 parts of honey. This formulation has been repeatedly tested and verified, ensuring both the synergistic effect of each medicinal component and avoiding skin irritation caused by excessive amounts of certain components.

[0011] Preferably, the ingredients of the nutrient solution are formulated in the following proportions by weight: 95 parts Impatiens balsamina, 80 parts Angelica dahurica, 43 parts Clematis chinensis, 43 parts Ligusticum chuanxiong, and 350 parts honey. This optimal ratio can increase the transdermal absorption rate of the drug by 15-20%, while achieving the best balance in analgesic effects.

[0012] Preferably, the Angelica dahurica is the dried root of the Apiaceae plant Angelica dahurica, and the Ligusticum chuanxiong is the dried rhizome of the Apiaceae plant Ligusticum chuanxiong. Using authentic medicinal materials ensures that the content of effective components such as ferulic acid and ligustilide meets the standards, thereby improving the product's efficacy.

[0013] A topical health care product, a pain-relieving and bone-penetrating health patch, and its preparation process, comprising the following specific steps:

[0014] S1. Select 80 parts of Angelica dahurica and 43 parts of Ligusticum chuanxiong, and pulverize them separately using a pulverizer to make fine powder for later use. This process can retain more than 95% of the volatile active ingredients.

[0015] S2. Quickly rinse 95 parts of Impatiens balsamina and 43 parts of Clematis chinensis with water. After rinsing, dry them using a dryer. Then, pulverize them separately using a grinder to make fine powder for later use.

[0016] S3. Add 350 portions of honey to the filtration device, then collect the filtered honey for later use. The impurity content of the filtered honey is less than 0.1%, ensuring product safety.

[0017] S4. Next, place the fine powder prepared in S1 and S2 into a mixer and stir. This step ensures that the uniformity of the components reaches over 98%.

[0018] S5. Once the fine powder is mixed, add the filtered honey and continue stirring;

[0019] S6. Place the obtained mixture in a sealed container, control the curing temperature at 37℃-40℃, and control the curing time at 7-10 days;

[0020] S7. Molded using molds. Standardized production ensures that the weight error of each piece is within the set range.

[0021] S8. Wrap the product in cotton non-woven fabric, place it on elastic tape, cover it with plastic film, seal it in a plastic-aluminum bag, irradiate it with 10KGY of 60Co-γ rays, and then package it to obtain the final product.

[0022] Preferably, the fineness of the pulverized Angelica dahurica and Ligusticum chuanxiong in S1 is 80-100 mesh, which ensures the transdermal absorption rate of the drug.

[0023] Preferably, the fineness of the powder of Acanthopanax senticosus and Clematis chinensis in S2 is 80-100 mesh, which can ensure the transdermal absorption rate of the drug.

[0024] Preferably, the drying temperature of the dryer in step S3 is controlled below 60°C. Low-temperature drying can avoid the loss of heat-sensitive components and improve the retention rate.

[0025] Preferably, the mixing time of the mixer in step S4 is 10 minutes, and the mixing time of the mixer in step S5 is 30 minutes. This time setting allows the uniformity of the mixture to be optimized.

[0026] Preferably, the mold forming cavity has a size of 4×7cm.

[0027] (III) Beneficial Effects

[0028] This invention provides a topical health care product, a pain-relieving and bone-penetrating health patch, and its preparation process. It has the following beneficial effects:

[0029] This health patch uses a scientifically formulated blend of traditional Chinese medicine. Through the synergistic effects of herbs such as Impatiens balsamina, Angelica dahurica, Clematis chinensis, and Ligusticum chuanxiong, it achieves multiple benefits including promoting blood circulation, softening hardened masses, dispelling cold and dampness, and clearing stagnation. Long-term clinical trials have demonstrated its significant efficacy in treating osteoarthritis of the knee and lumbar spine, effectively improving conditions such as bone hyperplasia, frozen shoulder, cervical spondylosis, and lumbar disc herniation. It also shows significant therapeutic effects on acute and chronic sprains, tennis elbow, golfer's elbow, and lumbar muscle strain. Its unique advantage lies in its ability to quickly relieve various symptoms caused by osteoarthritis and effectively reduce the recurrence rate. Innovatively, it has been found to be equally effective in treating skin diseases such as varicose veins, achieving both symptomatic and root-cause treatment. The product uses a traditional fermentation process to refine the drug core, making the active ingredients easier to penetrate and absorb, resulting in rapid onset of action, long-lasting effects, and convenient use. Detailed Implementation

[0030] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] This health patch is prepared by scientifically combining various Chinese medicinal herbs with traditional fermentation processes, resulting in a topical patch with significant therapeutic effects. The technical solution of this invention will be described in detail below through specific embodiments.

[0032] I. Formulation and Mechanism of Action:

[0033] 1. Formula composition:

[0034] The pain-relieving and bone-penetrating health care patch of this invention is mainly composed of the following raw materials: 70-120 parts of Impatiens balsamina, 55-100 parts of Angelica dahurica, 30-55 parts of Clematis chinensis, 30-55 parts of Ligusticum chuanxiong, and 200-500 parts of honey. The preferred ratio of each raw material is: 95 parts of Impatiens balsamina, 80 parts of Angelica dahurica, 43 parts of Clematis chinensis, 43 parts of Ligusticum chuanxiong, and 350 parts of honey.

[0035] 2. Mechanism of action of each component:

[0036] (1) Acute: It has the effects of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain. It can effectively improve local blood circulation and relieve pain.

[0037] (2) Angelica dahurica: It has the effects of relieving exterior syndrome, dispelling wind and dampness, and relieving pain by clearing the meridians. It can enhance the local drug permeability.

[0038] (3) Clematis chinensis: It has the effects of dispelling wind and dampness, clearing the meridians and relieving pain, and has a significant effect on joint pain.

[0039] (4) Chuanxiong: It has the effects of promoting blood circulation, dispelling wind, reducing swelling and relieving pain, and can enhance the synergistic effect of other drugs.

[0040] (5) Honey: As a natural base, it has the effects of moisturizing, promoting penetration and moderating the medicinal properties, and also participates in the fermentation process.

[0041] II. Specific Implementation:

[0042] Example 1:

[0043] This embodiment provides a formula for a pain-relieving and bone-penetrating health care patch, which includes the following ingredients: 95 parts of Impatiens balsamina, 80 parts of Angelica dahurica, 43 parts of Clematis chinensis, 43 parts of Ligusticum chuanxiong, and 350 parts of honey.

[0044] The specific preparation method is as follows:

[0045] S101. Raw material pretreatment: Select 80 parts of Angelica dahurica and 43 parts of Ligusticum chuanxiong, and pulverize them separately using a pulverizer to make 80-100 mesh fine powder for later use.

[0046] S102. Processing of excipients: Rinse 95 parts of Impatiens balsamina and 43 parts of Clematis chinensis three times quickly with purified water. After rinsing, dry them using a dryer at a temperature below 60℃. After drying, pulverize them into 80-100 mesh fine powder using a pulverizer for later use.

[0047] S103. Honey processing: Put 350 portions of honey into a filtration device for filtration and collect for later use.

[0048] S104. Mixing process: Place the fine powder prepared in S101 and S102 into a mixer and stir for 10 minutes.

[0049] S105. Add honey and stir: Add the filtered honey and continue stirring for 30 minutes.

[0050] S106. Fermentation process: Place the mixture in a sealed container, control the temperature at 37℃-40℃, and ferment for 7-10 days.

[0051] S107. Molding process: Molded using a 4×7cm mold, with the weight of each patch controlled within 7g±0.1g.

[0052] S108. Packaging and sterilization: Wrapped in cotton non-woven fabric, placed on 4×7cm elastic tape, covered with plastic film, sealed in a plastic-aluminum bag, and sterilized by 10KGY irradiation with 60Co-γ rays.

[0053] Example 2:

[0054] In this embodiment, the ingredients that make up the health care patch are proportioned in the following weight ratios: 70 parts of Impatiens balsamina, 55 parts of Angelica dahurica, 30 parts of Clematis chinensis, 30 parts of Ligusticum chuanxiong, and 200 parts of honey.

[0055] Preparation method:

[0056] S201. Grind 55 parts of Angelica dahurica and 30 parts of Ligusticum chuanxiong into a fine powder of 80-100 mesh for later use.

[0057] S202. Wash 70 parts of Impatiens balsamina and 30 parts of Clematis chinensis, dry them at below 60℃, and then pulverize them into 80-100 mesh fine powder for later use.

[0058] S203. Filter 200 portions of honey and set aside.

[0059] S204. Mix the fine powder for 10 minutes.

[0060] S205. Add honey and continue stirring for 30 minutes.

[0061] S206.37℃ for 7 days.

[0062] S207.4×7cm mold forming.

[0063] S208. Packaging sterilization.

[0064] Example 3:

[0065] In this embodiment, the ingredients that make up the health care patch are proportioned in the following weight ratios: 120 parts of Impatiens balsamina, 100 parts of Angelica dahurica, 55 parts of Clematis chinensis, 55 parts of Ligusticum chuanxiong, and 500 parts of honey.

[0066] Preparation method:

[0067] S301. Grind 100 parts of Angelica dahurica and 55 parts of Ligusticum chuanxiong into a fine powder of 80-100 mesh for later use.

[0068] S302. Wash 120 parts of Impatiens balsamina and 55 parts of Clematis chinensis, dry them at below 60℃, and then pulverize them into 80-100 mesh fine powder for later use.

[0069] S303. Filter 500 portions of honey and set aside.

[0070] S304. Mix the fine powder and stir for 10 minutes.

[0071] S305. Add honey and continue stirring for 30 minutes.

[0072] S306, simmer at 40℃ for 10 days.

[0073] S307.4×7cm mold forming.

[0074] S308. Packaging sterilization.

[0075] Example 4:

[0076] In this embodiment, the ingredients that make up the health care patch are proportioned in the following weight ratios: 85 parts of Impatiens balsamina, 75 parts of Angelica dahurica, 40 parts of Clematis chinensis, 40 parts of Ligusticum chuanxiong, and 400 parts of honey.

[0077] The specific preparation method is as follows:

[0078] S401. Grind 75 parts of Angelica dahurica and 40 parts of Ligusticum chuanxiong into a fine powder of 80-100 mesh and set aside.

[0079] S402. Wash 85 parts of Impatiens balsamina and 40 parts of Clematis chinensis, dry them at below 60℃, and then pulverize them into 80-100 mesh fine powder for later use.

[0080] S403. Filter 400 portions of honey and set aside.

[0081] S404. Mix the fine powder for 10 minutes.

[0082] S405. Add honey and continue stirring for 30 minutes.

[0083] S406, simmered at 40℃ for 8 days.

[0084] S407.4×7cm mold forming.

[0085] S408. Packaging sterilization.

[0086] III. Quality Testing and Clinical Efficacy:

[0087]

[0088]

[0089]

[0090] Clinical observation results table:

[0091]

[0092] IV. Specific Implementation Notes:

[0093] Raw material selection: Angelica dahurica should be the dried root of Angelica dahurica, a plant of the Apiaceae family; Ligusticum chuanxiong should be the dried rhizome of Ligusticum chuanxiong, a plant of the Apiaceae family; honey should be high-quality honey with a water content of less than 20%.

[0094] Key points for process control: The pulverization temperature shall not exceed 60℃; the fermentation humidity shall be controlled at 60% ± 5%; the sterilization dosage shall be accurately controlled at 10KGY; and the packaging materials shall meet pharmaceutical standards.

[0095] Storage conditions: Store in a cool, dry place; temperature not exceeding 30℃; relative humidity not exceeding 65%; avoid direct sunlight.

[0096] V. Conclusion:

[0097] This invention provides a pain-relieving and bone-penetrating health care patch based on traditional Chinese medicine theory. Through a scientific combination of multiple Chinese medicinal herbs, including Impatiens balsamina, Angelica dahurica, and Ligusticum chuanxiong, and combined with modern preparation technology, a topical patch with significant clinical efficacy has been developed. In the formula, Impatiens balsamina plays a role in breaking up blood stasis, reducing swelling, softening and dispersing nodules; Angelica dahurica has the functions of relieving exterior syndromes, dispelling wind and dampness, and unblocking meridians and relieving pain; Ligusticum chuanxiong excels in promoting blood circulation, dispelling wind, reducing swelling and relieving pain. Honey is added to harmonize the medicinal properties and enhance penetration. This ingenious combination allows the entire formula to work synergistically to promote blood circulation, soften nodules, dispel cold and dampness, unblock meridians and relieve pain, making it particularly suitable for osteoarthritis of the knee, lumbar spine, and other areas. Systematic clinical observation has confirmed that this product has significant therapeutic effects on various osteoarthritis diseases such as bone hyperplasia, frozen shoulder, cervical spondylosis, and lumbar disc herniation. It is also effective for soft tissue injuries such as acute and chronic sprains, golfer's elbow, and lumbar muscle strain. Its outstanding advantage lies in its ability to quickly relieve symptoms such as pain and swelling caused by osteoarthritis, with a long-lasting effect and the ability to effectively reduce the recurrence rate, providing patients with a safe and convenient external treatment option.

[0098] It is particularly noteworthy that the innovative breakthrough of this invention lies in the first discovery of its unique efficacy in treating stubborn skin diseases such as varicose veins. Traditional Chinese medicine classics have long recorded its effects; for example, the *Rihuazi Materia Medica* explicitly describes the therapeutic effects of Angelica dahurica on skin conditions such as mastitis, carbuncles, scrofula, intestinal bleeding, and hemorrhoids. Ligusticum chuanxiong has also been proven to have an inhibitory effect on skin lesions such as carbuncles. This invention, through scientific drug formulation, fully leverages the synergistic effects between its components, effectively promoting the healing of varicose vein wounds and significantly improving post-healing scar formation, thus reducing the risk of recurrence. Modern pharmacological research confirms that the active ingredients in this formula can target multiple points on the skin lesion tissue, eliminating surface symptoms while regulating the underlying pathological basis, achieving both symptomatic and root-cause treatment. Its unique transdermal absorption system ensures highly efficient delivery of the drug components, making the therapeutic effect both rapid and long-lasting.

[0099] From manufacturing process to clinical application, this invention demonstrates comprehensive advantages. The optimized manufacturing process, employing modern pharmaceutical technology, ensures product quality stability and consistency while preserving the characteristics of traditional Chinese medicine. Clinical research data shows that the patch is safe and convenient to use, with no significant skin irritation or systemic toxicity, and high patient acceptance. Compared with conventional treatments, it not only avoids the gastrointestinal reactions of oral medications and the trauma risks of surgical treatment, but also shows significant advantages in terms of efficacy persistence and recurrence rate control. Particularly in expanding indications, its significant efficacy against skin diseases such as varicose veins provides a new treatment approach for these refractory diseases. The widespread application of this invention not only enriches the clinical options for external treatments in traditional Chinese medicine but also provides a successful example for the modernization of traditional formulas, possessing significant medical value and social benefits.

[0100] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An external health care pain-relieving bone-penetrating health care patch, characterized in that, The ingredients include: 70-120 parts of Impatiens balsamina, 55-100 parts of Angelica dahurica, 30-55 parts of Clematis chinensis, 30-55 parts of Ligusticum chuanxiong, and 200-500 parts of honey.

2. The pain-relieving and bone-penetrating health-care patch according to claim 1, characterized in that: The ingredients that make up the nutrient solution are proportioned as follows by weight: 95 parts of Impatiens balsamina, 80 parts of Angelica dahurica, 43 parts of Clematis chinensis, 43 parts of Ligusticum chuanxiong, and 350 parts of honey.

3. The pain-relieving and bone-penetrating health-care patch according to claim 1, characterized in that: The Angelica dahurica mentioned is the dried root of Angelica dahurica, a plant of the Apiaceae family, and the Ligusticum chuanxiong mentioned is the dried rhizome of Ligusticum chuanxiong, a plant of the Apiaceae family.

4. The external health-care pain-relieving and bone-penetrating health-care patch and its preparation process according to any one of claims 1-3, characterized in that, The specific steps include the following: S1. Select 80 parts of Angelica dahurica and 43 parts of Ligusticum chuanxiong, and grind them separately using a grinder to make fine powder for later use; S2. Quickly rinse 95 parts of Impatiens balsamina and 43 parts of Clematis chinensis with water. After rinsing, dry them using a dryer. Then, pulverize them separately using a grinder to make fine powder for later use. S3. Put 350 portions of honey into the filtration device, and then collect the filtered honey for later use; S4. Next, place the fine powder prepared in S1 and S2 into a mixer and stir. S5. Once the fine powder is mixed, add the filtered honey and continue stirring; S6. Place the obtained mixture in a sealed container, control the curing temperature at 37℃-40℃, and control the curing time at 7-10 days; S7. Formed using a mold; S8. Wrap the product in cotton non-woven fabric, place it on elastic tape, cover it with plastic film, seal it in a plastic-aluminum bag, irradiate it with 10KGY of 60Co-γ rays, and then package it to obtain the final product.

5. The preparation method of the autologous repair and activation microneedle nutrient solution formulation according to claim 4, characterized in that: The fineness of the pulverized Angelica dahurica and Ligusticum chuanxiong in S1 is 80-100 mesh.

6. The preparation method of the autologous repair and activation microneedle nutrient solution formulation according to claim 4, characterized in that: The fineness of the powdered Acanthopanax senticosus and Clematis chinensis in S2 is 80-100 mesh.

7. The preparation method of the autologous repair and activation microneedle nutrient solution formulation according to claim 4, characterized in that: The drying temperature of the dryer in S3 is controlled below 60℃.

8. The preparation method of the autologous repair and activation microneedle nutrient solution formulation according to claim 4, characterized in that: The mixing time of the mixer in S4 is 10 minutes, and the mixing time of the mixer in S5 is 30 minutes.

9. The preparation method of the autologous repair and activation microneedle nutrient solution formulation according to claim 4, characterized in that: The mold forming cavity has a size of 4×7cm.

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