Traditional Chinese medicine gel plaster for palpitation, heart health regulation and cardiovascular circulation improvement and preparation method of traditional Chinese medicine gel plaster

Abstract

The invention belongs to innovative plasters, and relates to a transdermal drug delivery technology, in particular to a traditional Chinese medicine gel plaster for palpitation, heart health regulation and cardiovascular circulation improvement and a preparation method of the traditional Chinese medicine gel plaster. Through a transdermal drug delivery mode, the medicine has the obvious advantages of being good in viscosity, high in permeability, rapid in absorption, high in safety and large in drug carrying amount, and meanwhile the problems that no external drug treatment vacancy exists in the heart field, and heart abnormality cannot be rapidly relieved under the condition that the medicine is difficult to take and eat in the heart field are solved.

Description

Technical Field

[0001] The present invention belongs to the technical fields of traditional Chinese medicine, pharmaceutics, and transdermal drug delivery, and particularly relates to a traditional Chinese medicine gel plaster for palpitations and regulating heart health, and a preparation method thereof, which is particularly suitable for assisting in relieving abnormal heartbeat and improving cardiovascular circulation through transdermal drug delivery. Background Art

[0002] Current heart health management mostly relies on oral medications or invasive treatments, which have problems such as slow onset, large side effects, and low patient compliance. In the prior art, there is a lack of non-invasive solutions for directly regulating heart function through external transdermal drug delivery. The present invention fills the gap in external medications for heart abnormalities by combining traditional Chinese medicine active ingredients with acupoint stimulation.

[0003] Usual diagnostic methods rely on instruments such as ambulatory electrocardiogram, cardiac electrical examination, and Holter monitoring. In the current medical model, observation without medication is carried out in the early stage, oral blockers are used in the middle stage, and surgery, pacemaker implantation, or radiofrequency ablation is required in the later stage. The present invention is applicable to the early and middle stages of heart problems such as arrhythmia and palpitations.

[0004] Existing treatment methods are mostly invasive or semi-invasive. For patients, the acceptance is limited, and there are certain risks and side effects. They can only be used as means in the middle and later stages, lacking external medication adjuvant treatment in the early and middle stages, and unable to quickly relieve heart abnormalities in cases of difficulty in eating.

[0005] Therefore, a traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation, and a preparation method thereof are proposed, aiming to provide a more acceptable treatment option for patients with palpitations. The plaster jointly regulates the heart rate and prevents and relieves the occurrence of heart abnormalities by combining the stimulation of Neiguan acupoint / Qimen acupoint and the blood-activating and meridian-passing, sedative and tranquilizing effects of the drug itself. Summary of the Invention

[0006] In order to overcome the problems that existing heart health management relies on invasive / semi-invasive treatment means (such as pacemaker implantation, radiofrequency ablation) or oral medications, with low patient acceptance, large side effects, slow onset, and a lack of external medication adjuvant treatment means in the early and middle stages, and being unable to quickly relieve heart abnormal symptoms in a non-invasive manner in cases of difficulty in eating or emergencies, therefore, a traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation is proposed.

[0007] The technical solution of the present invention is as follows: A traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation, which is composed of the following components:

[0008] The traditional Chinese medicine gel plaster is composed of crude drugs and a matrix, and the finished product can act on Neiguan acupoint or Qimen acupoint;

[0009] Original medicine: including 3-9 parts of iron filings and 1-3 parts of salvia miltiorrhiza;

[0010] Matrix: including penetrant, stabilizer, thickener, humectant, preservative, antioxidant, conditioner and penetration enhancer, and the specific components are as follows:

[0011] Penetrant: azone, propylene glycol;

[0012] Stabilizer: hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol (PVA);

[0013] Thickener: carbomer, acrylate pressure-sensitive adhesive;

[0014] Humectant: glycerol;

[0015] Preservative: phenoxyethanol;

[0016] Antioxidant: VE, disodium EDTA;

[0017] Conditioner: allantoin;

[0018] Penetration enhancer: oleic acid.

[0019] Preferably, the main component of the iron filings is magnetite (Fe3O4), and the active components of the salvia miltiorrhiza are tanshinone IIA and salvianolic acid.

[0020] Preferably, the acrylate pressure-sensitive adhesive is Duro-Tak 87-2287 type pressure-sensitive adhesive.

[0021] Preferably, the mass ratio of azone to propylene glycol in the penetrant is 1:(1-3).

[0022] Preferably, the mass ratio of hydroxypropyl methylcellulose to polyvinyl alcohol in the stabilizer is (1-2):1.

[0023] Preferably, the mass ratio of carbomer to acrylate pressure-sensitive adhesive in the thickener is (1-3):10.

[0024] The present invention also provides a preparation method of a traditional Chinese medicine gel plaster for palpitations, regulating heart health and improving cardiovascular circulation, which includes a traditional Chinese medicine gel plaster for palpitations, regulating heart health and improving cardiovascular circulation as described above, and the preparation steps are as follows:

[0025] Step 1: Original medicine treatment

[0026] Iron filings extraction: Crush the iron filings into fine powder of 150 meshes, add 1% dilute hydrochloric acid solution, stir and extract at 50°C for 2 hours, filter and adjust the pH to 6.5-7.0 with ammonia water to extract iron ions;

[0027] Salvia miltiorrhiza extraction: The Salvia miltiorrhiza is crushed into coarse powder, 60% ethanol is added, and extraction is carried out for 3 hours (taking into account the extraction of tanshinone and salvianolic acid). After filtration, the medicinal liquid is mixed with the ferrum extract;

[0028] Concentration: The mixed liquid is concentrated under reduced pressure at 60 °C and 0.08 MPa to a relative density of 1.20 - 1.25 to obtain the original medicinal extract;

[0029] Step Two: Matrix forming

[0030] The stabilizers (hydroxypropyl methylcellulose, polyvinyl alcohol) are added to normal temperature water for swelling, heated to 50 °C, and successively the penetrants (azone, propylene glycol), thickeners (carbomer, acrylate pressure - sensitive adhesive), humectants (glycerol), preservatives (phenoxyethanol), antioxidants (VE, disodium EDTA), conditioners (allantoin), and penetration enhancers (oleic acid) are added, and continuously stirred and mixed evenly to form a uniform matrix;

[0031] Step Three: Plaster forming

[0032] The original medicinal extract and the matrix are heated in a water bath at a constant temperature of 50 °C - 80 °C, continuously stirred for 1 hour to make them fully mixed. After the mixed liquid is filtered through a 0.22 μm filter membrane, it is coated on a PET release film (thickness 0.5 mm), dried with hot air at 60 °C for 10 minutes, covered with a non - woven fabric backing layer, cut and then filled with nitrogen and sealed (aluminum foil bag, oxygen content ≤ 0.5%), and stored in the dark (≤ 25 °C).

[0033] Advantages of the present invention:

[0034] 1. In the present invention, by transdermally applying to the Neiguan point / Qimen point, the penetrants (azone, propylene glycol, oleic acid) in the matrix act synergistically to form a composite penetration - enhancing system, enabling the iron ions (Fe 3+ ) in the ferrum and the active ingredients such as tanshinone IIA in the Salvia miltiorrhiza to rapidly penetrate through the stratum corneum of the skin and directly act on the deep layer of the acupoints and the circulatory system, avoiding the systemic toxic and side effects of oral drugs and the trauma of invasive treatment. The stabilizers (hydroxypropyl methylcellulose, polyvinyl alcohol) and thickeners (carbomer, acrylate pressure - sensitive adhesive) construct a visco - elastic matrix, ensuring close adhesion of the plaster to the skin. At the same time, through the sustained - release technology, the drug release rate is controlled (the cumulative drug release amount in 24 hours ≥ 80%), reducing the burden of frequent medication and improving patient compliance;

[0035] 2. Iron filings (mainly containing Fe3O4) can inhibit the overexcitation of myocardial electrical activity by regulating the GABA level in the central nervous system, quickly relieve acute symptoms such as palpitations and dizziness, and fill the non-invasive treatment gap in emergency situations; Danshen (mainly containing tanshinone IIA and salvianolic acid) dilates the coronary artery, improves myocardial microcirculation, and reduces blood viscosity. Long-term use can repair myocardial damage and prevent the recurrence of arrhythmia, meeting the "prevention + conditioning" needs in the early and middle stages; The combination of acupoint stimulation and drug penetration: Apply it to Neiguan acupoint / Qimen acupoint (key acupoints of the heart meridian). Through the dual effects of physical stimulation and active ingredients of the drug, it can achieve two-way regulation of heart rate and shorten the onset time (30% - 50% faster than oral medications), especially suitable for scenarios where eating is difficult or rapid intervention is required.

[0036] 3. Existing topical preparations have problems such as low drug loading, poor penetration, and insufficient stability. However, the present invention has achieved a technological breakthrough through matrix formulation optimization and process innovation: Precise proportioning of matrix components: The penetrant (azone: propylene glycol = 1:1 - 3) and the penetration enhancer (oleic acid) work synergistically to increase the transdermal rate of tanshinone IIA by 42% compared to the single azone system (cumulative release rate of 38.7% in 48 hours), ensuring efficient absorption of active ingredients; The humectant (glycerol) and the conditioner (allantoin) reduce dryness and irritation at the application site. Verified by rabbit skin tests, the erythema / edema score ≤ 1 grade, and the safety is better than that of commercially available patches; The antioxidant (VE, disodium EDTA) prevents the oxidation of iron ions and the degradation of Danshen components. Combined with nitrogen-filled sealed packaging (oxygen content ≤ 0.5%), the stability can meet the requirement of no significant change after storing for 3 days at 40°C / 75% RH. The acid extraction process of iron filings (50°C, 1% dilute hydrochloric acid) and the alcohol extraction process of Danshen (60% ethanol, 3 hours) can precisely retain the active form of Fe3O4 and the integrity of tanshinone IIA. Detected by X-ray diffraction and HPLC, the loss rate of active ingredients ≤ 5%, ensuring stable drug efficacy.

[0037] 4. The present invention fills the gap in topical medications for the heart field and broadens the treatment scenarios. In the existing technology, topical medications for heart diseases are almost blank. The present invention fills the market and clinical needs through the following innovations: Wide range of applications: For the early and middle stages of heart problems such as palpitations and arrhythmia, it can be used alone or in combination with oral medications, providing new options for patients who cannot tolerate invasive treatments or need long-term management; Convenience of use: The patch dosage form can be applied and replaced at any time without professional medical equipment, adapting to multiple scenarios such as home care and outdoor emergencies, solving the limitations of existing treatments that rely on medical facilities. Detailed implementation methods

[0038] The present invention will be further described below in conjunction with embodiments.

[0039] Example 1: The present invention provides an example: A traditional Chinese medicine gel patch for palpitations, regulating heart health, and improving cardiovascular circulation, which is composed of the following components:

[0040] The traditional Chinese medicine gel plaster is composed of the original medicine and the matrix, and the finished product can act on the Neiguan acupoint or the Ximen acupoint.

[0041] Original medicine: including 3-9 parts of iron filings and 1-3 parts of Salvia miltiorrhiza.

[0042] Matrix: including penetrant, stabilizer, thickener, humectant, preservative, antioxidant, conditioner and penetration enhancer, and the specific components are as follows:

[0043] Penetrant: azone, propylene glycol;

[0044] Stabilizer: hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol (PVA);

[0045] Thickener: carbomer, acrylate pressure-sensitive adhesive;

[0046] Humectant: glycerol;

[0047] Preservative: phenoxyethanol;

[0048] Antioxidant: VE, disodium EDTA;

[0049] Conditioner: allantoin;

[0050] Penetration enhancer: oleic acid.

[0051] Preferably, the main component of the iron filings is magnetite (Fe3O4), and the active components of Salvia miltiorrhiza are tanshinone IIA and salvianolic acid.

[0052] Preferably, the acrylate pressure-sensitive adhesive is Duro-Tak87-2287 type pressure-sensitive adhesive.

[0053] Preferably, the mass ratio of azone to propylene glycol in the penetrant is 1:(1-3).

[0054] Preferably, the mass ratio of hydroxypropyl methylcellulose to polyvinyl alcohol in the stabilizer is (1-2):1.

[0055] Preferably, the mass ratio of carbomer to acrylate pressure-sensitive adhesive in the thickener is (1-3):10.

[0056] The present invention also provides a preparation method of a traditional Chinese medicine gel plaster for palpitations, regulating heart health and improving cardiovascular circulation, which includes a traditional Chinese medicine gel plaster for palpitations, regulating heart health and improving cardiovascular circulation as described above, and the preparation steps are as follows:

[0057] Step 1: Original medicine treatment

[0058] Iron filings extraction: Crush iron filings into fine powder of 150 mesh, add 1% dilute hydrochloric acid solution, stir and extract at 50 °C for 2 hours. After filtration, adjust the pH to 6.5 - 7.0 with ammonia water to extract iron ions;

[0059] Salvia miltiorrhiza extraction: Crush Salvia miltiorrhiza into coarse powder, add 60% ethanol, extract for 3 hours (taking into account the extraction of tanshinones and salvianolic acids), and mix the medicinal liquid with the iron filings extraction liquid after filtration;

[0060] Concentration: Concentrate the mixed liquid under reduced pressure at 60 °C and 0.08 MPa to a relative density of 1.20 - 1.25 to obtain the original medicinal extract;

[0061] Step two: Matrix forming

[0062] Add stabilizers (hydroxypropyl methylcellulose, polyvinyl alcohol) to swell in normal temperature water, heat to 50 °C, and sequentially add penetrants (azone, propylene glycol), thickeners (carbomer, acrylate pressure - sensitive adhesive), humectants (glycerol), preservatives (phenoxyethanol), antioxidants (VE, disodium EDTA), conditioners (allantoin), and penetration enhancers (oleic acid), and continuously stir and mix evenly to form a uniform matrix;

[0063] Step three: Plaster forming

[0064] Heat the original medicinal extract and the matrix in a water bath at 50 °C - 80 °C for constant temperature, continuously stir for 1 hour to mix them evenly. After the mixed liquid is filtered through a 0.22 μm filter membrane, coat it on a PET release film (thickness 0.5 mm), dry in hot air at 60 °C for 10 minutes, cover with a non - woven backing layer, cut and seal with nitrogen (aluminum foil bag, oxygen content ≤ 0.5%), and store in the dark (≤ 25 °C).

[0065] Example 2: The present invention provides an example: A traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation, which is composed of the following components:

[0066] Original medicine: 6 parts of iron filings, 2 parts of Salvia miltiorrhiza (both taking the intermediate values to balance the effects of calming the mind and promoting blood circulation to remove stasis);

[0067] Matrix:

[0068] Penetrant: Azone: Propylene glycol = 1:2 (mass ratio, taking the intermediate value to enhance the transdermal synergistic effect);

[0069] Stabilizer: Hydroxypropyl methylcellulose: Polyvinyl alcohol = 1.5:1 (mass ratio, optimizing the thermal stability of the matrix);

[0070] Thickener: Carbomer: Acrylate pressure - sensitive adhesive (DuroTak872287) = 2:10 (mass ratio, balancing viscoelasticity and plastering comfort);

[0071] The remaining matrix components (glycerol, phenoxyethanol, VE, disodium EDTA, allantoin, oleic acid) are adjusted synchronously according to the proportion in Example 1.

[0072] The present invention also provides a preparation method of a traditional Chinese medicine gel plaster for palpitations, regulating heart health and improving cardiovascular circulation, which includes a traditional Chinese medicine gel plaster for palpitations, regulating heart health and improving cardiovascular circulation as described above, and the preparation steps are as follows:

[0073] Treatment of raw medicine:

[0074] 50 g of iron filings are ground into fine powder of 150 meshes, added with 500 ml of 1% dilute hydrochloric acid solution, stirred and extracted at 50 °C for 2 hours, the pH is adjusted to 6.8 with ammonia water, and filtered;

[0075] 20 g of Salvia miltiorrhiza are ground into coarse powder, added with 200 ml of 60% ethanol (10 times the mass of Salvia miltiorrhiza), extracted for 3 hours, and the filtrate is mixed with the iron filings extract;

[0076] The mixed solution is concentrated under reduced pressure to a relative density of 1.23 at 60 °C and 0.08 MPa to obtain about 25 g of extract.

[0077] Matrix forming:

[0078] After 15 g of hypromellose and 10 g of polyvinyl alcohol are swollen, 10 ml of azone, 20 ml of propylene glycol, 20 g of carbomer, 100 g of pressure-sensitive adhesive, 30 ml of glycerol and other components are added in sequence, and stirred at 50 °C until uniform.

[0079] Plaster forming:

[0080] The extract and the matrix are mixed at 60 °C for 1 hour, filtered and then coated on a PET release film, dried at 60 °C for 10 minutes, and cut and sealed.

[0081] Example 3: The present invention provides an example: a traditional Chinese medicine gel plaster for palpitations, regulating heart health and improving cardiovascular circulation, which is composed of the following components:

[0082] Raw medicine: 3 parts of iron filings (lower limit), 3 parts of Salvia miltiorrhiza (upper limit) (focusing on improving myocardial microcirculation, suitable for patients with higher blood viscosity);

[0083] Matrix:

[0084] Penetrant: Azone:propylene glycol = 1:3 (mass ratio, improving the penetration efficiency of hydrophilic Salvia miltiorrhiza components);

[0085] Stabilizer: Hypromellose:polyvinyl alcohol = 1:1 (mass ratio, enhancing the flexibility of the matrix);

[0086] Thickener: Carbomer: Acrylate Pressure - Sensitive Adhesive = 1:10 (mass ratio, reducing visco - elasticity, suitable for long - term application);

[0087] The remaining matrix components are the same as those in Example 1.

[0088] The present invention also provides a preparation method of a traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation. It includes a traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation as described above, and its preparation steps are as follows:

[0089] 1. Raw drug treatment:

[0090] 25 g of fine iron filings powder is extracted according to the method in Example 1;

[0091] 30 g of crude Danshen powder (taking the upper limit), adding 240 ml of 60% ethanol (8 times the mass of Danshen), extracting for 3 hours, and mixing the filtrate with the iron filings extract;

[0092] Concentrating to a relative density of 1.22 to obtain about 22 g of extract (the proportion of Danshen components is increased).

[0093] Matrix forming:

[0094] Focus on controlling the proportion of the penetrant. 5 ml of azone and 15 ml of propylene glycol are used to ensure the transdermal absorption efficiency of tanshinone IIA.

[0095] Plaster forming:

[0096] Adjust the coating thickness to 0.4 mm (a thinner dosage form, suitable for sensitive skin), and the drying and sealing conditions are the same as those in Example 1.

[0097] Example 4: The present invention provides an example: a traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation, which is composed of the following components:

[0098] Raw drugs: 9 parts (upper limit) of iron filings, 1 part (lower limit) of Danshen (focusing on quickly relieving palpitations, suitable for patients in the acute attack period);

[0099] Matrix:

[0100] Penetrant: Azone: Propylene glycol = 1:1 (mass ratio, balancing the penetration of lipophilic iron ions and water - soluble components);

[0101] Stabilizer: Hydroxypropyl methylcellulose: Polyvinyl alcohol = 2:1 (mass ratio, enhancing the mechanical strength of the matrix and avoiding the sedimentation of iron filings components);

[0102] Thickener: Carbomer: Acrylate Pressure - Sensitive Adhesive = 3:10 (mass ratio, enhancing adhesion and ensuring the stability of acupoint application);

[0103] The other matrix components are the same as those in Example 1.

[0104] The present invention also provides a preparation method of a traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation, which includes a traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation as described above, and the preparation steps are as follows:

[0105] Raw drug treatment:

[0106] 75 g (taking the upper limit) of fine iron filings are added with 750 ml of 1% dilute hydrochloric acid solution, extracted at 50 °C for 2 hours, and the pH is adjusted to 6.6 with ammonia water;

[0107] 10 g of crude Danshen powder is added with 100 ml of 60% ethanol, extracted for 3 hours, and the filtrate is mixed with the iron filings extract;

[0108] Concentrate to a relative density of 1.25 (high-concentration extract, increasing the iron ion drug loading amount) to obtain about 30 g of extract.

[0109] Matrix forming:

[0110] Increase the proportion of hypromellose (20 g), 10 g of polyvinyl alcohol, and add a high proportion of carbomer (30 g) after swelling to ensure the uniform dispersion of the iron filings extract.

[0111] Plaster forming:

[0112] The water bath heating temperature is controlled at 80 °C (promoting the fusion of the high-concentration extract and the matrix), and the coating thickness is 0.6 mm, which is suitable for scenarios where rapid onset is required.

[0113] Example 5: A, B, and C were all found to have arrhythmia problems by a doctor, and were accompanied by dizziness, fatigue, and syncope, and their diet and sleep were extremely irregular. The traditional Chinese medicine plaster prepared in Example 1 of the present invention was applied on the Neiguan acupoint once a day for seven consecutive days.

[0114] Table 1 is an analysis table of the physical states of A, B, and C after applying the traditional Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation prepared in Example 1 of the present invention.

[0115]

[0116]

[0117] Through the above steps, the three patients achieved the improvement of heart function and overall state by applying the traditional Chinese medicine gel plaster prepared in Example 1 of the present invention, and its action mechanism and technical advantages are as follows:

[0118] 1. The raw drug components targetedly regulate heart function

[0119] Iron filings (Fe3O4) rapidly relieve acute symptoms:

[0120] After acid extraction, iron filings penetrate into the tissues around the Neiguan acupoint in the form of Fe 3+ By regulating the level of γ-aminobutyric acid (GABA) in the central nervous system, it inhibits the excessive excitement of the electroactivity of cardiomyocytes, thus rapidly alleviating discomfort such as palpitations and dizziness. Patients A, B, and C felt a reduction in the frequency of palpitations within 24 hours of application, and their heart rhythms gradually returned to the normal range within 7 days, verifying the first-aid effect of iron filings in "calming the mind and soothing the nerves".

[0121] Salvia miltiorrhiza (tanshinone IIA + salvianolic acid) long-term improves the circulatory system:

[0122] After alcohol extraction, tanshinone IIA in Salvia miltiorrhiza dilates the coronary arteries and increases myocardial blood supply, while salvianolic acid scavenges oxygen free radicals and protects cardiomyocytes. The blood viscosity of three patients decreased within 7 days (combined with the data in Example 5), and the myocardial microcirculation improved, fundamentally repairing the damage and preventing the recurrence of arrhythmia, reflecting the long-term conditioning effect of Salvia miltiorrhiza in "activating blood circulation and dredging meridians".

[0123] 2. Matrix technology improves drug transdermal efficiency and application experience

[0124] Composite penetration system accelerates the onset of action:

[0125] The penetration enhancer composed of azone, propylene glycol, and oleic acid in the matrix increases the transdermal rate of iron ions and tanshinone IIA by 42% compared with the single system (refer to the technical solution of Example), and the drug rapidly penetrates through the stratum corneum of the skin to the deep layer of the acupoint, avoiding the first-pass effect of the liver for oral drugs. Patients reported that symptoms such as dizziness and fatigue were relieved 68 hours after application, and the onset time was shortened by 50% compared with oral drugs.

[0126] Viscoelastic matrix ensures long-term sustained release:

[0127] The matrix formed by hydroxypropyl methylcellulose, polyvinyl alcohol, and carbomer controls the 24-hour cumulative release rate of the drug ≥80%, avoiding fluctuations in blood drug concentration. The adhesion of the plaster is maintained at 0.5 - 1.0 N / cm 2 (meeting the quality standards of the example), which not only ensures continuous stimulation of the acupoint but also reduces the discomfort of skin traction. None of the three patients had adverse reactions such as redness, swelling, or itching, and their sleep quality gradually became regular due to the relief of symptoms.

[0128] 3. Acupoint stimulation and drugs synergistically enhance the overall curative effect

[0129] Neiguan acupoint targets and regulates heart rate:

[0130] Applied to the Neiguan acupoint (a key acupoint of the Pericardium Meridian), through the dual effects of physical compression and drug penetration, it activates the vagus nerve reflex and regulates the function of the cardiac autonomic nerves. The patient's heart rhythm gradually returns to normal from a disordered state, and the accompanying syncope tendency disappears, reflecting the dual-directional regulatory effect of the "acupoint drug" on the heart rate.

[0131] Underlying logic for the improvement of the overall body state:

[0132] The stability of cardiac function drives the optimization of the circulatory system, thereby improving the blood supply and oxygen supply to the whole body. The improvement of the patient's physical condition and regular diet benefit from the restoration of gastrointestinal function after Danshen improves microcirculation; the normalization of mental state is closely related to the sedative and tranquilizing effect of Iron Filings and the reduction of anxiety caused by palpitations.

[0133] All three patients were in the mid- to early stages of arrhythmia. Traditional treatments mainly involve observation or oral medications, which have problems such as poor compliance and obvious side effects. The plaster of the present invention is administered transdermally externally, avoiding the gastrointestinal irritation (such as nausea, constipation) of oral blockers and without the risk of surgery. It is especially suitable for people with irregular diet and sleep patterns who have difficulty taking long-term medications. After 7 consecutive days of application, all indicators gradually improve, verifying its clinical value of "safe, convenient, and efficient".

[0134] The above has made a detailed description of the embodiments of the present invention. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the purpose of the present invention.

Claims

1. A Chinese medicine gel plaster for palpitations, regulating heart health, and improving cardiovascular circulation, characterized in that It is composed of the following ingredients: The Chinese medicine gel plaster is composed of the original medicine and the matrix, and the finished product can act on the Neiguan acupoint or the Ximen acupoint; Technical material: including 3-9 parts of iron root and 1-3 parts of salvia miltiorrhiza; Matrix: includes penetrants, stabilizers, thickeners, moisturizers, preservatives, antioxidants, conditioners and penetration enhancers. The specific ingredients are as follows: Penetrants: Azone, propylene glycol; Stabilizer: Hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol (PVA); Thickener: Carbomer, acrylic pressure-sensitive adhesive; Humectant: Glycerin; Preservative: Phenoxyethanol; Antioxidants: VE, disodium EDTA; Conditioning agent: Allantoin; Penetration enhancer: oleic acid.

2. A Chinese medicine gel patch for relieving palpitations, regulating heart health, and improving cardiovascular circulation according to claim 1, characterized in that: The main component of the iron fall is ferroferric oxide (Fe3O4), and the effective components of salvia miltiorrhiza are tanshinone ⅡA and salvianolic acid.

3. A Chinese medicine gel plaster for relieving palpitations, regulating heart health, and improving cardiovascular circulation according to claim 1, characterized in that: The acrylic pressure-sensitive adhesive is Duro-Tak87-2287 pressure-sensitive adhesive.

4. A Chinese medicine gel plaster for relieving palpitations, regulating heart health, and improving cardiovascular circulation according to claim 1, characterized in that: The mass ratio of azone to propylene glycol in the penetrant is 1:(1-3).

5. A Chinese medicine gel plaster for relieving palpitations, regulating heart health, and improving cardiovascular circulation according to claim 1, characterized in that: The mass ratio of hydroxypropyl methylcellulose to polyvinyl alcohol in the stabilizer is (1-2):

1.

6. A Chinese medicine gel patch for relieving palpitations, regulating heart health, and improving cardiovascular circulation according to claim 1, characterized in that: The mass ratio of carbomer to acrylate pressure-sensitive adhesive in the thickener is (1-3):

10.

7. A method for preparing a Chinese medicine gel patch for palpitations, regulating heart health, and improving cardiovascular circulation, comprising the Chinese medicine gel patch for palpitations, regulating heart health, and improving cardiovascular circulation as described in claims 1-6, and the preparation steps are as follows: Step 1: Technical Processing Iron extraction: crush the iron into 150 mesh fine powder, add 1% dilute hydrochloric acid solution, stir and extract at 50℃ for 2 hours, filter and adjust pH to 6.5-7.0 with ammonia water to extract iron ions; Extraction of Danshen: Grind Danshen into coarse powder, add 60% ethanol, extract for 3 hours (taking into account the extraction of tanshinone and salvianolic acid), filter and mix the drug solution with iron extract; Concentration: The mixed solution is concentrated under reduced pressure at 60°C and 0.08MPa to a relative density of 1.20-1.25 to obtain the original drug extract; Step 2: Matrix Forming Add stabilizer (hydroxypropyl methylcellulose, polyvinyl alcohol) to water at room temperature to swell, heat to 50°C, add penetrant (azone, propylene glycol), thickener (carbomer, acrylate pressure-sensitive adhesive), moisturizer (glycerin), preservative (phenoxyethanol), antioxidant (VE, disodium EDTA), conditioner (allantoin), penetration enhancer (oleic acid) in sequence, stir and mix continuously to form a uniform matrix; Step 3: Plaster molding The original drug extract and the matrix were heated in a water bath at a constant temperature of 50°C to 80°C, stirred continuously for 1 hour to fully mix them, and the mixed solution was filtered through a 0.22μm filter membrane, coated on a PET release film (thickness 0.5mm), dried with hot air at 60°C for 10 minutes, covered with a non-woven fabric backing layer, and sealed with nitrogen after cutting (aluminum foil bag, oxygen content ≤0.5%), and stored away from light (≤25°C).

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