Traditional Chinese medicine heating patch for relieving kidney yang deficiency and cold type lumbago

Abstract

The application discloses a traditional Chinese medicine heating patch for relieving kidney-yang deficiency and cold type lumbago, and the heating patch comprises a backing layer, a heating layer, a medicine layer and a release layer which are stacked in sequence, and the medicine layer contains cinnamon, wine cistanche, herba epimedii, zanthoxylum bungeanum, wine ligusticum wallichii, cassia twig, salt artemia and clove in specific weight proportions. The application is accurate in prescription matching according to the pathogenesis of kidney-yang deficiency and cold type lumbago, i.e. kidney-yang deficiency is the root and cold congealing in meridians is the branch, and has good clinical effect and high safety.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine external preparation technology, specifically relating to a traditional Chinese medicine heat patch for relieving lower back pain caused by kidney yang deficiency and cold. Background Technology

[0002] Lower back pain is a common clinical symptom caused by various factors. Kidney Yang deficiency and cold syndrome is a significant type of chronic lower back pain, frequently seen in middle-aged and elderly individuals and patients with chronic kidney disease. Kidney Yang deficiency leads to impaired warming function, causing cold to stagnate in the meridians and hindering the flow of Qi and blood, resulting in lower back pain. Common symptoms include cold pain in the lower back, aggravated by cold and relieved by warmth, aversion to cold, cold limbs, and frequent urination with clear urine. In patients with chronic kidney disease (CKD), as the disease progresses, kidney Yang gradually weakens, often accompanied by intractable lower back pain, severely impacting their quality of life. Currently, Western medicine primarily treats lower back pain in CKD with symptomatic pain relief, but nonsteroidal anti-inflammatory drugs (NSAIDs) and other analgesics may increase the burden on the kidneys, limiting their clinical application. Traditional Chinese medicine has unique advantages in treating lower back pain due to kidney Yang deficiency and cold. Oral administration of formulas that warm and tonify kidney Yang and dispel cold to relieve pain is a common treatment method; however, some patients find it difficult to adhere to the treatment due to gastrointestinal intolerance or poor medication adherence.

[0003] External application of traditional Chinese medicine is an important part of traditional Chinese medicine treatment methods. Applying medicine to the lower back allows the medicine to act directly on acupoints in the lower back (such as Shenshu, Mingmen, and Yaoyangguan), exerting its effects through a dual pathway of transdermal absorption and acupoint stimulation. This method has advantages such as direct action, avoiding the first-pass effect of the liver, reducing gastrointestinal irritation, and high patient compliance.

[0004] Currently available back pain patch products have the following shortcomings: 1. The drug formulation is not highly targeted, and insufficient attention is paid to chronic kidney disease complicated by lower back pain. Most commercially available back pain relief patches use herbs like mugwort, chuanxiong, angelica pubescens, and clematis chinensis—medicinal herbs that dispel wind, cold, and dampness—as their core ingredients. They primarily focus on dispelling wind and dampness, clearing the meridians, and relieving pain. However, they lack precise formulation designs for the core pathogenesis of kidney-yang deficiency-cold type back pain, which is characterized by "kidney-yang deficiency as the root cause and cold stagnation in the meridians as the manifestation," often neglecting the fundamental aspect of warming and tonifying kidney-yang. Furthermore, most products are general-purpose designs, not specifically tailored to the unique constitution and medication needs of patients with chronic kidney disease.

[0005] 2. Insufficient synergistic design between the heating layer and the drug layer. Most existing heating patch products are simply a combination of a heating layer and a drug layer. While the warmth generated by the heating layer helps promote transdermal drug absorption, there is a lack of synergistic design between the heating temperature, heating duration, and drug release rate. When the heating layer directly contacts the drug layer, high-temperature heat convection may cause volatile active ingredients (such as cinnamaldehyde and eugenol) in the drug layer to be rapidly lost in the early stages of application, resulting in a shortened duration of efficacy. In addition, if the heat generated by the heating layer is not homogenized, local hot spots can easily appear, increasing the risk of skin burning and irritation.

[0006] Therefore, developing a traditional Chinese medicine fever patch with a formulation targeting kidney-yang deficiency and cold type of low back pain and chronic kidney disease complicated with low back pain, and with the synergistic effect of the heat layer and the drug layer, has important clinical significance and application value. Summary of the Invention

[0007] This invention addresses the shortcomings of existing technologies by providing a traditional Chinese medicine heating patch for relieving lower back pain due to kidney yang deficiency and cold, and its preparation method. The heating patch comprises a backing layer, a heating layer, a drug layer, and a release layer. The drug layer contains the following raw materials in parts by weight: 2-6 parts cinnamon, 6-12 parts *Cistanche deserticola* (processed with wine), 2-6 parts *Epimedium brevicornu*, 6-12 parts Sichuan pepper, 6-12 parts *Ligusticum chuanxiong* (processed with wine), 6-12 parts cinnamon twig, 4-8 parts *Mantis religiosa ootheca* (processed with salt), and 2-4 parts cloves.

[0008] Preferably, the above-mentioned medicinal layer contains the following raw materials in parts by weight: 3-5 parts cinnamon, 8-10 parts wine-processed Cistanche deserticola, 3-5 parts Epimedium, 8-10 parts Sichuan pepper, 8-10 parts wine-processed Ligusticum chuanxiong, 8-10 parts cinnamon twig, 5-7 parts salt-processed Mantis egg case, and 3 parts cloves.

[0009] More preferably, the above-mentioned medicinal layer contains the following raw materials in parts by weight: 5 parts cinnamon, 10 parts wine-processed Cistanche deserticola, 5 parts Epimedium, 10 parts Sichuan pepper, 10 parts wine-processed Ligusticum chuanxiong, 10 parts cinnamon twig, 6 parts salt-processed Mantis egg case, and 3 parts cloves.

[0010] The drug layer formulation described in this invention is an empirical formula that has been continuously summarized and improved by our hospital through many years of clinical practice, and its clinical application effect is good.

[0011] The formula used in the drug layer of this invention is an empirically effective formula obtained by the applicant through long-term clinical diagnosis and treatment and repeated optimization and screening. Clinical external application has verified its definite improvement effect on lower back pain caused by kidney yang deficiency and cold. The formula uses cinnamon and cistanche as the principal herbs: cinnamon tonifies fire and assists yang, dispels cold and relieves pain, and guides fire back to its source; cistanche tonifies kidney yang, benefits essence and blood, and moistens the intestines. Together, they warm the kidneys and strengthen yang to treat the root cause, achieving the effect of warming the kidneys and dispelling cold. The assistant herbs are epimedium, which warms the kidneys and strengthens yang, and cinnamon twig, which warms and unblocks the meridians, assists yang and transforms qi. Together, they assist the principal herbs in warming the kidneys, unblocking yang, dispelling cold, and relieving pain. The adjuvant herbs are chuanxiong (processed with wine), which invigorates blood and qi, dispels wind and relieves pain; Sichuan pepper, which warms the middle jiao, dispels cold, removes dampness and relieves pain; and mantis egg case (processed with salt), which tonifies the kidneys, consolidates essence, and reduces urination. Salt-processed mantis egg case guides the medicine to the kidneys, addressing the root cause of chronic kidney disease. The three herbs work together to enhance the warming and root-strengthening effects. The guiding herb, clove, warms the middle jiao and dispels cold, warms the kidneys and assists yang. Its aromatic properties are penetrating and refreshing, and it also promotes good transdermal absorption, guiding the medicine into the meridians. The entire formula primarily warms and tonifies kidney yang, supplemented by dispelling cold and unblocking the meridians, addressing both the root cause and the symptoms. It is precisely formulated to target the pathogenesis of kidney yang deficiency-cold type lower back pain and chronic kidney disease complicated with lower back pain.

[0012] The heating layer can be manufactured using existing technology to achieve the shape, structure, heating temperature, and heating time required by this invention. The self-heating technology of self-heating patches is already mature, and the raw materials, proportions, and preparation methods are well-known technologies; they can also be directly purchased.

[0013] Preferably, the backing layer, heating layer, drug layer, and release layer are rectangular sheet structures stacked sequentially; the length and width dimensions of the backing layer are greater than those of the heating layer, and the length and width dimensions of the heating layer are greater than or equal to those of the drug layer. The drug layer is preferably 11-13 cm long and 2-3 cm wide.

[0014] Preferably, a microporous breathable insulating membrane is provided between the heating layer and the drug layer. This microporous breathable insulating membrane is a commercially available general-purpose microporous breathable substrate, such as a microporous PE breathable membrane. Its uniform microporous structure limits the oxygen permeation rate and stabilizes the rate of the exothermic oxidation reaction of the heating layer. This structural design can serve as a temperature buffer, block heat convection, and slow-release volatile components of the extract. Simultaneously, it reduces the risk of skin burning and irritation caused by the combined effects of continuous heat and the high transdermal permeability of the extract, and prevents liquid from the drug layer from seeping into the heating layer.

[0015] The aforementioned microporous breathable isolation membrane is the same size as the heating layer and completely covers the upper surface of the heating layer. The two are fixed by four-sided hot pressing composite, so that the heating layer and the drug layer are isolated from each other and do not come into direct contact.

[0016] The heating layer of the present invention has a heating temperature of 40-45℃ and a continuous heating time of 4-6 hours.

[0017] Preferably, the drug layer may further include excipients, such as hot melt pressure-sensitive adhesive, transdermal penetration enhancer, and moisturizing and shaping agent. Further, the transdermal penetration enhancer is selected from one of azone, propylene glycol, and menthol, and the amount of the transdermal penetration enhancer added is 0.5%-2% of the total weight of the traditional Chinese medicine raw materials.

[0018] The present invention provides a method for preparing the traditional Chinese medicine heating patch, comprising the following steps: (a) Take cinnamon, wine-processed Cistanche deserticola, Epimedium, Sichuan pepper, wine-processed Ligusticum chuanxiong, cinnamon twig, salt-processed Mantis egg case, and cloves, extract them using solvent extraction, collect the extract, concentrate it, and obtain the drug extract; (b) The drug extract obtained in step (a) is placed on a carrier to form a drug layer; (c) Take the heating layer covered with the microporous breathable isolation membrane, laminate it onto the backing layer, laminate the drug layer onto the middle of the microporous breathable isolation membrane, and cover it with release paper to obtain the product.

[0019] Preferably, the solvent extraction method in step (a) includes a volatile oil extraction step and an alcohol extraction step: (a1) Take cinnamon, Sichuan pepper and cloves, extract volatile oil by steam distillation, and collect the volatile oil; (a2) Take the dregs from step (a1) and combine them with wine-processed Cistanche deserticola, Epimedium, wine-processed Ligusticum chuanxiong, Cinnamomum cassia, and salt-processed Mantis egg case. Extract them using the ethanol reflux extraction method, collect the extract and concentrate it into a thick paste. (a3) Mix the volatile oil obtained in step (a1) with the thick paste obtained in step (a2) to obtain the drug extract.

[0020] The conditions for the steam distillation method described in step (a1) are: the amount of water added is 6-10 times the weight of the medicinal material, the soaking time is 30-60 minutes, and the extraction time is 2-4 hours.

[0021] Preferably, the volatile oil obtained in step (a1) is encapsulated with β-cyclodextrin to form a volatile oil-β-cyclodextrin inclusion complex, which is then combined with the thick paste obtained in step (a2). β-cyclodextrin encapsulation technology can effectively improve the stability and water solubility of volatile oils and reduce the loss of volatile components during preparation and storage.

[0022] Preferably, the inclusion conditions are: the ratio of volatile oil to β-cyclodextrin is 1:4-1:8, the inclusion temperature is 30-50℃, and the inclusion time is 1-3 hours.

[0023] Preferably, the conditions for ethanol reflux extraction in step (a2) are: ethanol volume fraction 60%-90%, material-liquid ratio 1:6-1:10, extraction temperature 60-80℃, extraction time 1.0-2.0 hours, and extraction times 1-3 times.

[0024] Preferably, the carrier in step (b) is a medical non-woven fabric or cotton sheet with a thickness of 1-4 mm. The drug extract is placed on the carrier by coating, impregnation, or spraying. The dosage is such that the carrier is moistened but the drug extract does not drip or overflow.

[0025] Preferably, step (c) specifically involves fixing the heating layer directly to the center of the backing, with a double-sided adhesive material attached to the center of the heating layer. The backing is selected from medical tape or low-allergenic medical pressure-sensitive adhesive, and its length and width are each 20mm or more larger than the heating layer. The drug layer is fixed to the center of a microporous breathable insulating membrane integral with the heating layer using the double-sided adhesive material, covered with release paper, and then sealed in a bag.

[0026] Before use, unpack the individually packaged herbal heating patch, remove the release paper, align the medicine layer with the Shenshu acupoint or Ashi acupoint, and then apply the backing to the skin.

[0027] Furthermore, this invention provides the application of the above-mentioned traditional Chinese medicine heating patch in the preparation of drugs or medical devices for relieving lower back pain caused by kidney yang deficiency and cold.

[0028] The present invention has the following beneficial effects: 1. Precise formulation and strong targeting: The whole formula is based on warming and tonifying kidney yang, supplemented by dispelling cold and unblocking the meridians, taking into account both the root cause and the symptoms. It is precisely formulated to address the pathogenesis of kidney yang deficiency and cold type low back pain and low back pain in chronic kidney disease, and has good clinical effects.

[0029] 2. The microporous breathable isolation membrane achieves multiple synergistic functions: The present invention sets a microporous breathable isolation membrane between the heating layer and the drug layer. This structural design can play the role of temperature buffering, blocking heat convection, and slow-release of volatile components of the extract. At the same time, it reduces the risk of skin burning and irritation caused by the high transdermal properties of the extract due to continuous heat, and can prevent the liquid of the drug layer from seeping into the heating layer.

[0030] 3. High safety and patient compliance: This invention uses a traditional Chinese medicine external patch, avoiding oral administration, thus preventing the first-pass effect of the liver and gastrointestinal irritation. It is especially suitable for patients with chronic kidney disease and other individuals who are not suitable for oral medication. The integrated design of the heating layer and the drug layer makes it convenient to use, improves patient compliance, and is suitable for long-term conditioning. Attached Figure Description

[0031] Figure 1 This is a schematic cross-sectional view of the traditional Chinese medicine heating patch of the present invention; Figure 2 This is a top view of the structure of the herbal fever patch of the present invention.

[0032] 1-Backing, 2-Heating layer, 3-Microporous breathable insulating membrane, 4-Double-sided pressure-sensitive adhesive, 5-Medication layer Detailed Implementation

[0033] The present invention will be further described in detail below through specific embodiments. These embodiments are for illustrative purposes only and should not be considered as limiting the scope of the invention. Experimental methods not specifically described in the embodiments are generally performed under conventional conditions or as recommended by the manufacturer.

[0034] Example 1: Preparation of drug extract (volatile oil extraction + alcohol extraction) 1.1 Weighing of raw materials Weigh the following Chinese medicinal materials according to the following weights: 50g cinnamon, 100g wine-processed cistanche, 50g epimedium, 100g Sichuan pepper, 100g wine-processed chuanxiong, 100g cinnamon twig, 60g salt-processed mantis egg case, and 30g cloves.

[0035] 1.2 Extraction of volatile oils Take cinnamon, Sichuan pepper, and cloves, add 8 times the volume (volume / weight ratio) of distilled water, and soak for 45 minutes. Extract by steam distillation for 3 hours according to the volatile oil determination method in the Chinese Pharmacopoeia, collect the volatile oil, and encapsulate it with β-cyclodextrin.

[0036] 1.3 Alcohol extraction and concentration of medicinal residue Take the residue from step 1.2 and combine it with Cistanche deserticola (processed with wine), Epimedium, Ligusticum chuanxiong (processed with wine), Cinnamomum cassia, and Mantis egg case (processed with salt). Add 10 times the volume (volume / weight ratio) of 75% ethanol and extract under reflux at 70°C for 1.0 hour, repeating the extraction twice. Combine the two extracts and filter through a 200-mesh filter cloth. Concentrate the filtrate under reduced pressure at 60°C and -0.08 MPa to a thick paste with a relative density of 1.15-1.25 (measured at 60°C).

[0037] 1.4 Concentration and Merging Add the volatile oil inclusion complex from step 1.2 to the above thick paste and stir until homogeneous to obtain the drug extract.

[0038] Example 2: Preparation of volatile oil-β-cyclodextrin inclusion complex 2.1 Enclosure Operation Take 60g of β-cyclodextrin, add an appropriate amount of distilled water, and heat to 40℃ to dissolve it, preparing a saturated solution. Take 10mL of the volatile oil obtained in step 1.2 of Example 1, dissolve it in an appropriate amount of anhydrous ethanol, and slowly add it dropwise to the saturated β-cyclodextrin solution under stirring. Control the inclusion temperature at 40℃ and stir for 3 hours.

[0039] 2.2 Post-treatment of inclusion complex After inclusion, the mixture was refrigerated at 4°C for 24 hours, filtered, and the precipitate was washed with a small amount of distilled water and anhydrous ethanol. The mixture was then vacuum dried at 40°C to obtain the volatile oil-β-cyclodextrin inclusion complex.

[0040] Example 3: Preparation of Traditional Chinese Medicine Heating Patches 3.1 Preparation of the drug layer Take 2g of the drug extract obtained in Example 1, spread it on a 2mm thick medical non-woven fabric sheet, and after it is completely absorbed, cut it into a rectangle with a length of 11cm and a width of 2cm to obtain the drug layer.

[0041] 3.2 Preparation of the heating layer The heating layer is a custom-made part, which is a rectangle 12cm long, 4cm wide and 0.5cm thick, with a microporous breathable insulating membrane covering and fixed on one side.

[0042] 3.3 Composite Take a 13cm long and 6cm wide backing layer (medical adhesive tape), and stick the non-porous breathable insulating film side of the heating layer to the adhesive surface in the middle of the backing layer. Then, stick the drug layer to the middle of the heating layer with double-sided pressure-sensitive adhesive. Finally, cover the exposed surfaces (i.e., the side facing the skin) of the drug layer and the heating layer with release paper to obtain the Chinese medicine heating patch. Seal and bag it.

[0043] Example 4: Quality Control of Traditional Chinese Medicine Heating Patches 4.1 Visual Inspection This product should be a rectangular sheet patch with a flat backing layer. The heating layer and the drug layer are separated by a microporous breathable isolation membrane. The drug layer should be brown to dark brown and have the characteristic aroma of medicinal materials such as cinnamon and cloves. The release paper should be completely covered.

[0044] 4.2 Weight difference inspection Take 10 patches of this product, weigh them to determine the total weight, remove the release paper, weigh the patches themselves, and calculate the average weight. The difference between the weight of each patch and the average weight should be within ±6%.

[0045] 4.3 Heating performance test Take one patch of this product, peel off the release paper, expose it to air, and use an infrared thermometer to measure the surface temperature of the heating layer. This product should begin to heat up within 5-10 minutes after the release paper is removed, maintain the temperature at 40-45℃, and continue to heat up for no less than 5 hours.

[0046] 4.4 Determination of Cinnamaldehyde Content The content of cinnamaldehyde in the drug layer was determined by high performance liquid chromatography (HPLC).

[0047] Chromatographic conditions: C18 column (4.6 mm × 250 mm, 5 μm); mobile phase: acetonitrile-water (35:65); detection wavelength: 290 nm; flow rate: 1.0 mL / min; column temperature: 30 °C.

[0048] Preparation of the test solution: Take an appropriate amount of the drug layer, weigh it accurately, place it in a stoppered conical flask, add 50 mL of methanol accurately, stopper tightly, weigh it, sonicate for 30 minutes, cool it, weigh it again, replenish the lost weight with methanol, shake well, filter it, and take the filtrate to obtain the test solution.

[0049] Example 5: Clinical efficacy experiment of traditional Chinese medicine heating patch Using the herbal fever patch of Example 3 of the present invention as a sample, a placebo patch with the same appearance as the sample but without the drug was prepared and used by 120 patients with chronic kidney disease of kidney yang deficiency and cold type with symptoms of lower back pain, soreness, and weakness, or lower back pain of kidney yang deficiency and cold type. The effect of the herbal fever patch on relieving lower back pain of kidney yang deficiency and cold type was investigated.

[0050] 5.1 Patient selection criteria: Main symptoms: lower back pain, weakness, and soreness, which worsen with cold and improve with warmth. Secondary symptoms: aversion to cold, cold limbs, frequent urination at night, fatigue, and pale complexion. Tongue and pulse: The tongue is pale and swollen, with a white and moist coating, and the pulse is deep, slow, and weak. If two or more primary symptoms and two or more secondary symptoms are present, combined with tongue and pulse diagnosis, the condition can be diagnosed as kidney yang deficiency and cold type lower back pain.

[0051] Applicants must be aged 18-70 years, have a VAS score ≥4, and have not used other medications or therapies for low back pain in the past two weeks. Low back pain caused by organic diseases such as lumbar fractures, tumors, tuberculosis, or infections must be excluded; the applicant must not be pregnant or lactating; there must be no skin breaks, infections, or allergies on the lower back; the applicant must not have serious primary diseases of the heart, liver, or hematopoietic system, or severe renal insufficiency (eGFR <15 ml / min); the applicant must not be allergic to any component of this product; and the applicant must not be participating in other clinical trials concurrently.

[0052] 5.2 Examination Methods: Patients were randomly divided into two groups. Upon enrollment, either the herbal heat patch or placebo patch of this invention was applied once daily for 4 hours, covering the Shenshu and Mingmen acupoints on the lower back. One course of treatment consisted of 7 consecutive days, with a total of 4 courses, each 3 days apart. Neither group used other medications for lower back pain or chronic kidney disease. Patients were followed up for 4 weeks after treatment cessation to observe long-term efficacy and recurrence. 5.3 Evaluation Indicators: (1) Visual Analog Scale (VAS) A 100mm visual analog scale was used, with 0 points indicating no pain and 10 points indicating unbearable pain. Assessments were conducted before treatment, after each course of treatment, and at a 4-week follow-up.

[0053] (2) TCM syndrome score for low back pain Table 1. Traditional Chinese Medicine Syndrome Scoring

[0054] (3) Oswestry Disability Index (ODI) The ODI scale was used to assess the impact of low back pain on daily living functions. It includes 10 items: pain intensity, self-care, lifting, walking, sitting, standing, sleep, social interaction, and travel. Each item is scored from 0 to 5, and the total score is from 0 to 50. The higher the score, the more severe the functional impairment.

[0055] (4) Observation of adverse reactions: Record the skin reaction at the application site (redness, swelling, itching, rash, burning sensation, etc.) and other systemic adverse reactions.

[0056] 5.4. Criteria for Evaluating Therapeutic Effect (1) Comprehensive efficacy assessment Table 2 Comprehensive Efficacy Evaluation Criteria

[0057] Overall effective rate = (clinically cured + significantly effective + effective) / total number of cases × 100% (2) Determination of pain relief Table 3 Criteria for Judging the Degree of Pain Relief

[0058] 5.5. Statistical Methods Data analysis was performed using SPSS 26.0 statistical software. Quantitative data were expressed as mean ± standard deviation (x ± s). Paired t-tests were used for within-group comparisons, and independent samples t-tests were used for between-group comparisons. Chi-square tests were used for categorical data. P < 0.05 was considered statistically significant.

[0059] 5.6. Results Data (1) Comparison of two sets of general data Table 4 Comparison of General Data

[0060] There were no statistically significant differences between the two groups of patients in terms of gender, age, disease duration, pre-treatment VAS score, and TCM syndrome score (P>0.05), making them comparable.

[0061] (2) Comparison of VAS scores before and after treatment in the two groups Table 5 Comparison of VAS scores before and after treatment in the two groups

[0062] *Note: Compared with before treatment, *P<0.05* (3) Comparison of TCM syndrome scores before and after treatment in the two groups Table 6 Comparison of TCM syndrome scores before and after treatment in the two groups

[0063] *Note: Compared with before treatment, *P<0.05* (4) Comparison of ODI scores before and after treatment in the two groups Table 7 Comparison of ODI scores before and after treatment in the two groups

[0064] *Note: Compared with before treatment, *P<0.05* (5) Comparison of the overall therapeutic effects between the two groups Table 8 Comparison of the overall therapeutic effects between the two groups

[0065] The overall effective rates of the two groups were compared, and the difference was statistically significant (P < 0.01).

[0066] (6) Comparison of adverse reactions between the two groups Table 9 Comparison of Adverse Reactions Between the Two Groups

[0067] The incidence of adverse reactions between the two groups was not statistically significant (P>0.05). All adverse reactions were mild local skin reactions that resolved spontaneously without specific treatment, and no serious adverse events occurred.

[0068] The above data show that the total effective rate of the herbal heating patch of this invention in treating kidney-yang deficiency-cold type low back pain reached 86.7%, significantly better than the placebo control group (31.7%). After treatment, VAS score, TCM syndrome score, and ODI score all decreased significantly, and no serious adverse reactions occurred. This indicates that the herbal heating patch of this invention is effective and safe in treating kidney-yang deficiency-cold type low back pain.

[0069] The herbal heating patch provided by this invention can be used to relieve lower back pain caused by kidney yang deficiency and cold, as well as lower back pain associated with chronic kidney disease. The product of this invention has a reasonable structural design, precise formulation, clear efficacy, and a mature and feasible preparation process, making it suitable for large-scale production. This invention uses a topical herbal patch, avoiding oral administration, thus avoiding the first-pass effect of the liver and gastrointestinal irritation. It is especially suitable for patients with chronic kidney disease and other individuals who are not suitable for oral medication. It has high safety, good patient compliance, and good industrial practical value and broad market application prospects.

Claims

1. A traditional Chinese medicine heat patch for relieving lower back pain due to kidney yang deficiency and cold, characterized in that, It includes a backing layer, a heating layer, a drug layer, and a release layer. The drug layer contains the following raw materials in parts by weight: 2-6 parts cinnamon, 6-12 parts wine-processed Cistanche deserticola, 2-6 parts Epimedium, 6-12 parts Sichuan pepper, 6-12 parts wine-processed Ligusticum chuanxiong, 6-12 parts cinnamon twig, 4-8 parts salt-processed Mantis egg case, and 2-4 parts cloves.

2. The herbal fever patch according to claim 1, characterized in that, The medicinal layer contains the following raw materials in parts by weight: 3-5 parts cinnamon, 8-10 parts wine-processed Cistanche deserticola, 3-5 parts Epimedium, 8-10 parts Sichuan pepper, 8-10 parts wine-processed Ligusticum chuanxiong, 8-10 parts cinnamon twig, 5-7 parts salt-processed Mantis egg case, and 3 parts cloves.

3. The traditional Chinese medicine fever patch according to claim 1, characterized in that, The medicinal layer contains the following raw materials in parts by weight: 5 parts cinnamon, 10 parts wine-processed Cistanche deserticola, 5 parts Epimedium, 10 parts Sichuan pepper, 10 parts wine-processed Ligusticum chuanxiong, 10 parts cinnamon twig, 6 parts salt-processed Mantis egg case, and 3 parts cloves.

4. The traditional Chinese medicine fever patch according to any one of claims 1-3, characterized in that, The backing layer, heating layer, drug layer, and release layer are rectangular sheet structures stacked one on top of the other; the length and width of the backing layer are larger than the length and width of the heating layer.

5. The traditional Chinese medicine fever patch according to claim 1, characterized in that, A microporous breathable isolation membrane is provided between the heating layer and the drug layer.

6. The traditional Chinese medicine heating patch according to claim 5, characterized in that, The heating layer has a heating temperature of 40-45℃ and a continuous heating time of 4-6 hours.

7. The traditional Chinese medicine fever patch according to claim 1, characterized in that, The drug layer also includes excipients, which include one or more of hot melt pressure-sensitive adhesives, transdermal penetration enhancers, and moisturizing and shaping agents.

8. The traditional Chinese medicine heating patch according to claim 1, characterized in that, The transdermal penetration enhancer is selected from azone, propylene glycol, and menthol, and the amount of the transdermal penetration enhancer added is 0.5%-2% of the total weight of the Chinese herbal raw materials.

9. The use of the traditional Chinese medicine heating patch according to claim 1, characterized in that, Used in the preparation of drugs or medical devices for relieving lower back pain caused by kidney yang deficiency and cold.

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