Wind-dispelling and pain-relieving patch for treating wind-cold migraine and application of wind-dispelling and pain-relieving patch

Abstract

The invention discloses a wind-dispelling and pain-relieving plaster for treating wind-cold migraine and application thereof, and belongs to the technical field of traditional Chinese medicine, the wind-dispelling and pain-relieving plaster is prepared from the following medicinal raw materials in parts by mass: ligusticum wallichii, asarum, fructus evodiae, radix angelicae and borneol; the invention further discloses a preparation method and application of the traditional Chinese medicine composition. The wind-dispelling and pain-relieving patch has the beneficial effects that the wind-dispelling and pain-relieving patch provided by the invention avoids gastrointestinal tract injury caused by alimentary tract metabolism of medicines in a transdermal administration manner, avoids cardiovascular contraindications of triptan medicines, is particularly suitable for patients who are intolerant to western medicines or have contraindications, not only can quickly relieve pain, but also can reduce the recurrence frequency, and has a good application prospect. In addition, treatment is carried out by applying the Dazhui acupoint application, operation is easy and convenient, no wound is caused, patient compliance is high, and exertion of the curative effect is better facilitated, so that the anxiety emotion is relieved, and the life quality is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular, relates to a kind of treating wind-damp type migraine Qufeng analgesic patch and its application. BACKGROUND

[0002] Migraine is the second largest neurological disability disease in the world, and its clinical features are recurrent, usually unilateral pulsatile, moderate to severe headache, and the headache usually lasts for 4-72 hours, often accompanied by many symptoms that bother patients, including nausea, vomiting, photophobia and phonophobia. Migraine increases the risk of anxiety, depression, sleep disorders and other diseases, and is associated with increased cardiovascular disease mortality, causing significant social and economic burden. The occurrence of migraine is complex and multifactorial, and in its pathogenesis, the cortex, hypothalamus, thalamic nuclei and brainstem regions involved in regulating autonomic nerves, emotions, cognition and sensory functions, and the peripheral nervous system are involved, but the specific mechanism is not completely clear. Traditional acute treatment drugs for migraine, such as triptans, NSAIDs, etc. can only relieve migraine symptoms, and cannot fundamentally reduce the frequency of migraine attacks and recurrence.

[0003] In the clinical practice of acute treatment of migraine, the traditional drug regimen mainly includes non-specific analgesic drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and specific treatment drugs such as triptans. However, the existing treatment regimen has significant limitations: first, nearly one-third of patients have insufficient response to triptan drugs; second, more than 20% of patients with cardiovascular disease are forced to give up such specific treatment due to drug contraindications; third, the non-standard use of NSAIDs and triptan drugs leads to a high incidence of medication overuse headache. The proportion of medication overuse in Chinese migraine patients has reached 11.7%, and such patients may progress to medication overuse headache (MOH) due to chronic headache and abnormally high frequency of attacks. It is worth noting that the existing drug system not only has a ceiling effect, but also has limited treatment accuracy due to the variety of drugs and insufficient targeting.

[0004] Therefore, the development of a new green treatment system has double clinical values: on the one hand, it can break through the bottleneck of traditional drug efficacy, and has a simplified drug type and a more targeted mechanism, and can achieve precise intervention in the pathological link of migraine through multi-target regulation; on the other hand, it can effectively avoid the risk of drug abuse, especially for special groups with cardiovascular comorbidities or NSAIDs contraindications, and can provide safer and more specific treatment options. This treatment paradigm innovation, which is simple, convenient, inexpensive and effective, not only meets the development trend of precision medicine, but also effectively reduces the incidence of drug-related adverse reactions, and provides a new breakthrough for building a migraine stepwise treatment system. The future trend of treating migraine will be to adopt a comprehensive treatment method, that is, to combine traditional Chinese medicine with Western medicine, acupuncture, acupoint sticking, psychological treatment and other methods in clinical application, and fully exert the advantages of traditional Chinese medicine in the diagnosis and treatment of the disease, and provide more choices for the treatment of migraine patients. SUMMARY

[0005] The application provides a wind-damp type migraine treating paste for dispelling wind and relieving pain and application thereof based on a targeted transdermal treatment system with a simplified compound compatibility strategy. The paste has a compound structure with less and precise drugs, and a binary synergistic system of vinegar paste and borneol penetration, so as to realize the advantages of small dose and high utilization rate. In addition, the paste takes Dazhui acupoint as a strategic drug delivery target, and based on the anatomical characteristics of Dazhui acupoint as a “sea of Yang meridians”, the paste takes advantage of the regulation of the Du meridian on the trigeminal nerve and vascular system, so that the drug components can reach the medullary center through the vertebrobasilar arterial plexus. In order to achieve the above purpose, the application adopts the following technical solutions.

[0006] The wind-damp type migraine treating paste for dispelling wind and relieving pain comprises the following raw medicinal materials in parts by mass: 10-20 parts of Chuanxiong, 1-6 parts of Qianhu, 1-6 parts of Wuzhuyu, 5-13 parts of Baizhi and 1-2 parts of Bingpian.

[0007] Preferably, the paste for dispelling wind and relieving pain comprises the following raw medicinal materials in parts by mass: 12-18 parts of Chuanxiong, 1-5 parts of Qianhu, 1-5 parts of Wuzhuyu, 7-11 parts of Baizhi and 1-2 parts of Bingpian.

[0008] Preferably, the paste for dispelling wind and relieving pain comprises the following raw medicinal materials in parts by mass: 14-16 parts of Chuanxiong, 2-4 parts of Qianhu, 2-4 parts of Wuzhuyu, 8-10 parts of Baizhi and 1-2 parts of Bingpian.

[0009] Preferably, the paste for dispelling wind and relieving pain further comprises a pharmaceutically acceptable excipient.

[0010] Preferably, the wind-damp pain-relieving patch is applied to the Dazhui acupoint. The Dazhui acupoint belongs to the Du channel, which is called the "sea of yang channels" and plays a vital role in regulating the yang qi of the human body, promoting blood circulation and promoting the recovery of nerve function. Its running path is recorded in the "Lingshu", "and the foot taiyang rises from the inner canthus, goes up the forehead, meets the vertex, enters the brain, and then goes out separately from the lower part of the body... Enters the kidney, and connects the kidney. The Du channel connects the brain and the kidney, nourishes the bones and the brain marrow, and dominates the running and distribution of the yang qi of the whole body. The Dazhui acupoint is the intersection of the three yang channels and the Du channel, and is the "meeting point of yang channels". It is mentioned in the "Lingshu" that "yang qi is the essence of the body, which nourishes the spirit and the tendons". The Dazhui acupoint can regulate the meridian qi of the Du channel and the six yang channels, and can calm the mind, soften the tendons and relieve pain.

[0011] The application also provides application of the wind-damp pain-relieving patch for treating the wind-cold type migraine.

[0012] The causes of the wind-cold type migraine mainly include three points: ① external wind-cold, ② insufficient congenital endowment, and ③ cold stagnation. The pathogenesis mainly includes three aspects: ① direct stimulation of external wind-cold, such as blowing cold wind, raining, long-term staying in a low-temperature environment of air conditioning, etc.; ② climate and environmental factors, when the wind-cold evil is abundant in winter, spring and sudden weather changes, the yang qi of the human body is easily restrained, and the wind-cold type migraine is easily caused; ③ insufficient congenital endowment, the body is easily invaded by wind-cold due to the low immunity and insufficient yang qi, thereby causing the wind-cold type migraine; ④ unsmooth blood circulation, the wind-cold stays for a long time or repeatedly invades, which can cause cold stagnation of blood vessels and repeated attacks of pain.

[0013] The application also provides a preparation method of the wind-damp pain-relieving patch.

[0014] Step one, the raw medicinal materials are weighed according to the proportion by weight, cleaned, dried, cut and uniformly mixed;

[0015] Step two, the raw medicinal materials in step one are ground into fine powder in a grinding machine and sieved through a traditional Chinese medicine sieve;

[0016] Step three, the fine powder in step two is uniformly mixed with rice vinegar, and then the mixture is pasted on sterilized non-woven fabric to obtain the wind-damp pain-relieving patch.

[0017] Preferably, the particle size of the fine powder is 200-300 meshes.

[0018] Preferably, the mixing ratio of the fine powder and the rice vinegar is 1:1.5 by mass.

[0019] The application has the following beneficial effects:

[0020] The traditional Chinese medicine composition provided by the application takes Chuanxiong as a monarch drug, dispels wind, dredges collaterals and relieves pain, is combined with Evodia, Herba Linderae and Radix Angelicae Dahuricae to warm yang, dispel cold, dispel wind and relieve pain, is combined with borneol to penetrate collaterals, leads other drugs to reach the diseased part, and finally is combined with rice vinegar to promote transdermal absorption of the drugs, harmonize the drug properties, and reduce irritation. The traditional Chinese medicine composition provided by the application is administered transdermally, avoids gastrointestinal injury caused by metabolism of the drugs in the digestive tract, circumvents cardiovascular contraindications of triptan drugs, is especially suitable for patients who are intolerant to western medicines or have contraindications, can not only relieve pain quickly but also reduce the recurrence frequency, and meets the needs of patients for long-term efficacy. Meanwhile, the wind-dispelling and pain-relieving patch is used to treat the acupoint of Dazhui, is simple and convenient to operate, is non-invasive, has high patient compliance, and is more conducive to exertion of the efficacy, so as to relieve anxiety and improve the quality of life. BRIEF DESCRIPTION OF DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description only show some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained without creative labor on the basis of these drawings.

[0022] Figure 1 It is an infrared thermal imaging monitoring diagram of the patient in case one;

[0023] Figure 2 It is a serum biomarker concentration trend diagram of the patient in case one. DETAILED DESCRIPTION

[0024] In order to make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are some of the embodiments of the present application, but not all the embodiments of the present application. Therefore, the following detailed description of the embodiments provided by the present application is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0025] The present embodiment selects five medicinal materials of Chuanqiong, Xixin, Wuzhuyu, Baizhi and Bingpian in the prescription design, forms a "small amount of precise" compound structure, breaks through the conventional mode of traditional Chinese medicine large compound multi-target intervention, and improves the overall treatment specificity. Secondly, the synergistic mechanism of each component is clear - Chuanqiong expands the cerebral blood vessels by playing a calcium channel blocking role, Xixin inhibits the COX-2 pathway to achieve anti-inflammatory and analgesic effect, Wuzhuyu regulates 5-HT receptors to relieve vasospasm, Baizhi blocks the release of CGRP, and Bingpian enhances the permeability of the blood-brain barrier, forming a multi-dimensional precise intervention network from vasomotor regulation to neurotransmitter regulation. Furthermore, in the preparation process, a binary synergistic system of "rice vinegar paste-ice cube penetration" is adopted - rice vinegar is used as a matrix solvent, and its weak acid environment significantly improves the solubility of alkaloid components; combined with the modification effect of bingpian on the lipid structure of the stratum corneum, the transdermal rate of the drug is improved, realizing the advantages of "small dose and high utilization rate" of drug administration. Finally, the present prescription combines meridian theory with molecular pharmacology: taking Dazhui as the strategic drug target, based on its anatomical characteristics as the "sea of Yang meridians", and taking advantage of the regulation of the Du meridian on the trigeminal vascular system, the drug components directly reach the medullary center through the vertebral basilar arterial plexus. The specific implementation is as follows:

[0026] A wind-damp type migraine relieving and pain-relieving patch, comprising the following raw medicinal materials: Chuanqiong, Xixin, Wuzhuyu, Baizhi and Bingpian.

[0027] Chuanqiong: It is the dried rhizome of Chuanqiong. It is warm in nature and pungent in taste. It has the effects of removing wind and relieving pain, and can dispel wind and cold evil. Chuanqiong is a blood medicine that can open the top of the head, dredge the Qi, and clear the eyes, and has the effects of dispelling wind and relieving the exterior, and warming the channels to relieve pain.

[0028] Baizhi: It is the dried root of Baizhi or Hangbaizhi. It is warm in nature and pungent in taste. When combined with Chuanqiong, it has the effects of dispelling wind and relieving the exterior, and unblocking the channels to relieve pain, and can guide the drug to the Yangming meridian, and has a synergistic effect with Chuanqiong in the Shaoyang meridian to enhance the dispersing effect of Chuanqiong.

[0029] Xixin: It is the dried root and rhizome of Beixinyin, Hanchengxinyin or Huaxinyin. It is pungent and spicy, and is good at dispelling wind and cold, and relieving pain. It is especially suitable for treating wind-cold headache.

[0030] Wuzhuyu: It is the dried nearly mature fruit of Wuzhuyu, Shihu or Shuamouwuzhuyu. It is hot in nature and bitter and pungent in taste. Modern research has found that Wuzhuyu can promote the synthesis and release of 5-HT into the blood by increasing the 5-HT in the central nervous system, and indirectly reduce the release of CGRP, thereby inhibiting the pain sensitization of chronic migraine.

[0031] Borneol: obtained by water vapor distillation and recrystallization of stems and leaves of Ainsliaea spp. or branches and leaves of camphor tree. It is cool in nature and bitter and acrid in taste. Borneol has the functions of opening the orifice and refreshing the spirit, clearing heat and relieving pain. It has a fragrance and can promote the transdermal absorption of drugs with high bioavailability. In addition, borneol also has the effects of analgesia and promoting the penetration of drugs through the blood-brain barrier.

[0032] As a preferred embodiment, the wind-damp relieving and pain-stopping patch comprises the following raw medicinal materials in mass fraction: 10-20 parts of Chuanxiong Rhizoma, 1-6 parts of Qianhu, 1-6 parts of Wuzhuyu, 5-13 parts of Baizhi and 1-2 parts of borneol.

[0033] As a preferred embodiment, the wind-damp relieving and pain-stopping patch comprises the following raw medicinal materials in mass fraction: 12-18 parts of Chuanxiong Rhizoma, 1-5 parts of Qianhu, 1-5 parts of Wuzhuyu, 7-11 parts of Baizhi and 1-2 parts of borneol.

[0034] As a preferred embodiment, the wind-damp relieving and pain-stopping patch comprises the following raw medicinal materials in mass fraction: 14-16 parts of Chuanxiong Rhizoma, 2-4 parts of Qianhu, 2-4 parts of Wuzhuyu, 8-10 parts of Baizhi and 1-2 parts of borneol.

[0035] As a preferred embodiment, the wind-damp relieving and pain-stopping patch further comprises a pharmaceutically acceptable excipient.

[0036] As a preferred embodiment, the wind-damp relieving and pain-stopping patch is applied to the Dazhui acupoint. The Dazhui acupoint belongs to the Du Meridian, which is called the “sea of yang meridians”. It plays a crucial role in regulating the yang qi of the human body, promoting the circulation of qi and blood and promoting the recovery of nerve function. Its running path is recorded in the “Lingshu”, “and the foot taiyang rises from the inner canthus, goes up the forehead, meets at the top of the head, enters the brain, and then comes out separately from the lower back...... enters the kidney, and connects the kidney”. The Du Meridian connects the brain and the kidney, nourishes the bones and the brain marrow, and dominates the running and distribution of the yang qi of the whole body. The Dazhui acupoint is the intersection of the three yang meridians and the Du Meridian, “the meeting point of yang meridians”, and it is mentioned in the “Lingshu” that “yang qi is the essence of the spirit, and it nourishes the muscles”. The Dazhui acupoint can regulate the meridian qi of the Du Meridian and the six yang meridians, and it can calm the spirit, soften the muscles and relieve pain.

[0037] The application also provides the application of the wind-damp relieving and pain-stopping patch for treating migraine caused by wind-cold in the above description in the treatment of migraine caused by wind-cold.

[0038] The application also provides a preparation method of the wind-damp relieving and pain-stopping patch described above, which comprises the following steps:

[0039] Step one, raw medicinal materials are weighed and selected according to the weight ratio, dried, cut and mixed uniformly;

[0040] Step two, the raw medicinal materials in step one are ground into fine powder in a grinding machine and sieved through a traditional Chinese medicine sieve;

[0041] Step three, mix the fine powder in step two with rice vinegar evenly, make into paste, and then paste on sterilized non-woven fabric, and then the product is obtained.

[0042] As a preferred embodiment, the particle size of the fine powder is 200-300 mesh.

[0043] As a preferred embodiment, the mixing ratio of the fine powder and the rice vinegar is 1:1.5.

[0044] The application will be further described in detail in combination with specific examples as follows:

[0045] Example 1

[0046] Example 1 provides a wind-damp type migraine treating paste, and the following Chinese medicine formula raw materials are taken by mass fraction: Chuanxiong 10 parts, Qianhu 1 part, Wuzhuyu 1 part, Baizhi 5 parts, Bingpian 1 part. The preparation method of Example 1 is as follows:

[0047] Step one, the raw medicine is weighed, cleaned, dried, cut and mixed evenly according to the weight ratio;

[0048] Step two, the raw medicine in step one is ground into fine powder with a particle size of 300 mesh in a grinding machine, and sieved through a Chinese medicine sieve;

[0049] Step three, mix the fine powder in step two with rice vinegar evenly, make into paste, and then paste on sterilized non-woven fabric, and then the product is obtained.

[0050] Example 2

[0051] Example 2 provides a wind-damp type migraine treating paste, and the following Chinese medicine formula raw materials are taken by mass fraction: Chuanxiong 12 parts, Qianhu 1 part, Wuzhuyu 1 part, Baizhi 7 parts, Bingpian 1 part. The preparation method of Example 2 is the same as that of Example 1.

[0052] Example 3

[0053] Example 3 provides a wind-damp type migraine treating paste, and the following Chinese medicine formula raw materials are taken by mass fraction: Chuanxiong 14 parts, Qianhu 2 parts, Wuzhuyu 2 parts, Baizhi 8 parts, Bingpian 1 part. The preparation method of Example 3 is the same as that of Example 1.

[0054] Example 4

[0055] Example 4 provides a wind-damp type migraine treating paste, and the following Chinese medicine formula raw materials are taken by mass fraction: Chuanxiong 15 parts, Qianhu 3 parts, Wuzhuyu 3 parts, Baizhi 9 parts, Bingpian 1 part. The preparation method of Example 4 is the same as that of Example 1.

[0056] Example 5

[0057] This embodiment 5 provides a wind-damp headache pain-relieving patch for treating wind-cold type migraine, and the following Chinese medicine formula raw materials are taken by mass parts: Chuanxiong 16 parts, Weixing 4 parts, Wuzhuyu 4 parts, Baizhi 10 parts, Bingpian 1 part. The preparation method of this embodiment 5 is the same as that of embodiment 1.

[0058] Embodiment 6

[0059] This embodiment 6 provides a wind-damp headache pain-relieving patch for treating wind-cold type migraine, and the following Chinese medicine formula raw materials are taken by mass parts: Chuanxiong 18 parts, Weixing 5 parts, Wuzhuyu 5 parts, Baizhi 11 parts, Bingpian 2 parts. The preparation method of this embodiment 6 is the same as that of embodiment 1.

[0060] Embodiment 7

[0061] This embodiment 7 provides a wind-damp headache pain-relieving patch for treating wind-cold type migraine, and the following Chinese medicine formula raw materials are taken by mass parts: Chuanxiong 20 parts, Weixing 6 parts, Wuzhuyu 6 parts, Baizhi 13 parts, Bingpian 2 parts. The preparation method of this embodiment 7 is the same as that of embodiment 1.

[0062] Clinical typical cases:

[0063] 1, Case 1

[0064] 1) Patient profile

[0065] Zhang, female, 42 years old, outdoor worker. Migraine history for 8 years, the frequency of attack increased to 4-6 times per month in the past 2 years.

[0066] 2) Complaints and medical history

[0067] ① Complaint: bilateral temporal pulsating headache, aggravated by wind and cold, accompanied by nausea and photophobia, each episode lasting 12-24 hours.

[0068] ② Inducing factors: cold weather outdoor work, cold wind blowing directly on the head.

[0069] ③ Previous treatment: oral administration of ibuprofen (initially effective, but in the past year the dose needs to be doubled to 600 mg per time); sumatriptan (contraindicated due to hypertension).

[0070] ④ Acupuncture treatment: twice a week, the efficacy is maintained for no more than 48 hours.

[0071] ⑤ Complications: history of drug overuse headache (MOH), using analgesics ≥15 days per month in the past 6 months.

[0072] 3) TCM differentiation

[0073] Four diagnoses: headache like a wrap, reduced by warming; pale tongue with thin white fur, tight pulse; generally cold and cold limbs, symptoms aggravated in winter. TCM syndrome is wind-cold type migraine.

[0074] 4) Treatment regimen

[0075] ① Intervention: Apply the wind-damp pain-relieving patch provided in Example 4 of the present application, 1 patch per day, continuously apply to Dazhui acupoint for 8 hours (use at night).

[0076] ② Acute phase: Apply immediately when headache occurs, use continuously for 7 days each time;

[0077] Remission phase: Apply every other day, continuously for 4 weeks.

[0078] ③ Contraindication management: Stop using all NSAIDs drugs and use cold compress physical analgesia instead.

[0079] 5) Efficacy observation indicators

[0080] Table 1 Comparison of symptoms before and after treatment of Case 1 patient

[0081] Evaluation dimension Baseline value After 4 weeks of treatment After 12 weeks of treatment MADIS pain score 50±15 20±5 5±5 Number of monthly attacks 5 ± 4 times 2 ± 2 times 1 ± 1 time Duration of each attack 18.6 ± 3.2 hours 6.5 ± 2.1 hours 4.2 ± 1.5 hours Number of days of analgesic use 18 days / month 3 days / month 0 days / month

[0082] (*p <0.05, compared with baseline value. The baseline value refers to the data before treatment of the patient)

[0083] 6) Key time node records of patients

[0084] Day 3: 30 minutes after the first application, the MADIS score of headache decreased from 65 to 50, and nausea did not occur.

[0085] Day 7: After encountering cold wind outdoors, the headache improved compared to before, with a MADIS score of 45, and no additional analgesic was used.

[0086] Day 21: Menstrual cycle induced headache, which was 60% less severe than before, and the patient reported that they could "work normally".

[0087] Day 60: No headache was induced when not wearing a hat during winter morning exercises (which was previously inevitable).

[0088] 7) Mechanism verification

[0089] ① Infrared thermal imaging monitoring: see Figure 1 , the temperature in the Dazhui acupoint area increased by 2.3°C after 1 hour of application, which can improve local microcirculation; the amplitude of temporal artery pulsation decreased by 42%, which can inhibit abnormal vascular dilation.

[0090] ② Serum biomarkers: see Figure 2 , CNTN2 content decreased from 53 pg / mL to 17.2 pg / mL; CGRP level decreased from baseline 98.5 pg / mL to 35.2 pg / mL (p <0.01); 5-HT concentration increased from 178 ng / mL to 56 ng / mL (regulate vascular tone).

[0091] 8) Safety evaluation

[0092] ① Skin reaction: no obvious abnormalities.

[0093] ② Blood pressure monitoring: systolic / diastolic pressure fluctuation range <5 mmHg (no impact on the cardiovascular system).

[0094] ③ Liver and kidney function: no significant changes in ALT, Cr and other indicators (avoiding liver and intestinal metabolism burden).

[0095] 9) Follow-up and recurrence prevention

[0096] After 6 months of follow-up, the patient's monthly attack frequency stabilized at 0-1 times, and MOH did not occur again.

[0097] 2, Case two

[0098] 1) Patient profile

[0099] Li, male, 35 years old, taxi driver. Migraine history for 5 years, attack frequency increased to 5-7 times per month in the past year.

[0100] 2) Complaints and medical history

[0101] ① Complaint: pulsating headache on the right temple, aggravated by cold wind or direct blowing of air conditioner, accompanied by chills and nausea, each lasting 8-12 hours.

[0102] ② Inducing factors: long time driving with windows open (cold wind blowing directly on the head), working at night in winter.

[0103] ③ Previous treatment: oral acetaminophen (initially effective, increased to 1000mg per dose in the past half year); NSAIDs were prohibited due to a history of gastric ulcer.

[0104] 3) TCM differentiation

[0105] Four diagnoses: headache like a needle, relieved by warmth; pale red tongue, thin white fur, pulse floating and tight; susceptible to cold, cold hands and feet. Differentiation is wind-cold invasion type of migraine

[0106] 4) Treatment plan

[0107] ① Intervention: apply the wind-eliminating and pain-stopping patch provided in Example 4 of the invention, 1 patch per day, continuously apply at Dazhui acupoint for 8 hours (used at night).

[0108] ② Acute phase: apply immediately when headache occurs, use continuously for 7 days each time;

[0109] Remission period: apply every other day, for 4 consecutive weeks.

[0110] ③ Contraindication management: discontinue all NSAIDs and replace them with ginger and red sugar water to assist in cold prevention.

[0111] 5) Efficacy observation

[0112] Table 2 Comparison of symptoms of patient in case two before and after treatment

[0113] Evaluation dimension Baseline value After 4 weeks of treatment After 12 weeks of treatment MADIS pain score 60±10 20±5 15±5 Number of monthly attacks 6 ± 3 times 4 ± 2 times 2±2 Duration of each attack 10 ± 2 hours 6 ± 2 hours 3±1 Number of days of analgesic use 7 days / month 5 days / month 1 day / month

[0114] (*p <0.05, compared with baseline value. The baseline value refers to the data of the patient before treatment)

[0115] 6) Follow-up and recurrence prevention

[0116] Follow-up for 3 months: no recurrence, no cold wind-induced headache during winter driving.

[0117] 7) Safety evaluation

[0118] ① Skin reaction: slight erythema on the skin, which returned to normal after 24 hours of drug withdrawal.

[0119] ② Blood pressure monitoring: the fluctuation range of systolic / diastolic pressure is <5 mmHg (without affecting the cardiovascular system).

[0120] ③ Liver and kidney function: no significant changes in ALT, Cr and other indicators (avoiding liver and intestinal metabolism burden).

[0121] 3, Case three

[0122] 1) Patient profile

[0123] Ms. Wang, female, 28 years old, office clerk. Migraine history for 2 years, the frequency of attack increased to 8-10 times per month in the past half year.

[0124] 2) Complaints and medical history

[0125] ① Complaints: frontal and bilateral temporal swelling pain, aggravated in air-conditioned environment, accompanied by photophobia and stiff neck and shoulder, each lasting for 6-8 hours.

[0126] ② Inducing factors: long-term stay in air-conditioned low-temperature environment, and getting cold before and after menstruation.

[0127] ③ Previous treatment: taking naproxen during acute phase (the effect gradually weakened); suspended Western medicine treatment due to the need for pregnancy preparation.

[0128] 3) TCM differentiation

[0129] Four diagnostic methods: headache like wrapping, severe with cold; pale tongue with teeth marks on the edge, and deep and fine pulse; usually little menstrual flow and dark color. The syndrome is wind-cold stagnation type of migraine.

[0130] 4) Treatment plan

[0131] ① Intervention measures: apply the wind-eliminating and pain-stopping patch provided in Example 4 of the present application, 1 patch per day, continuously apply at Dazhui acupoint for 8 hours (used at night).

[0132] ②Acute phase: apply immediately when headache occurs, use continuously for 7 days each time;

[0133] Remission phase: apply every other day, continuously for 4 weeks.

[0134] ③Contraindication management: stop using all NSAIDs drugs, and cooperate with moxibustion at Guanyuan acupoint to warm and tonify lower energizer.

[0135] 5) Efficacy observation

[0136] Table 3 Comparison of symptoms before and after treatment of case three patients

[0137] Evaluation dimension Baseline value After 4 weeks of treatment After 12 weeks of treatment MADIS pain score 55±12 30±5 0±5 Number of monthly attacks 9 ± 2 times 3 ± 2 times 1 ± 2 times Duration of each attack 7 ± 1.5 hours 3 ± 2 hours 1 ± 1 hour Number of days of analgesic use 7 days / month 0 days / month 0 days / month

[0138] (*p <0.05, compared with baseline value. Baseline value refers to the data before treatment of patients)

[0139] 6) Follow-up and recurrence prevention

[0140] Follow-up for 6 months: menstrual period did not induce headache due to cold, and headache frequency was stable at 0-1 times per month.

[0141] 7) Safety evaluation

[0142] ① Skin reaction: no obvious abnormality.

[0143] ② Blood pressure monitoring: systolic / diastolic pressure fluctuation range <5 mmHg (without affecting the cardiovascular system).

[0144] ③ Liver and kidney function: no significant changes in ALT, Cr and other indicators (avoiding liver and intestinal metabolism burden).

[0145] 4, Case four

[0146] 1) Patient profile

[0147] Mr. Chen, male, 55 years old, retired teacher. Migraine history for 12 years, chronic for 2 years with daily headache.

[0148] 2) Complaints and medical history

[0149] ① Complaint: persistent pain in the whole head, aggravated in winter morning, accompanied by dizziness and tinnitus, lasting for 4-6 hours per day.

[0150] ② Inducing factors: not wearing a hat when exercising in the morning, sudden weather changes.

[0151] ③ Past treatment: long-term use of aspirin (leading to gastrointestinal bleeding), and prohibited use of triptan drugs due to coronary heart disease history.

[0152] 3) TCM differentiation

[0153] Four diagnostic methods are combined: headache like a cone, get warm and comfortable; purple tongue, white and greasy moss, stringy pulse; the waist and knees are cold. The syndrome is yang deficiency and cold stagnation type of migraine.

[0154] 4) Treatment regimen

[0155] ① Intervention: apply the wind- expelling and pain- relieving patch provided in Example 4 of the present application, 1 patch per day, continuously apply to the Dazhui acupoint for 8 hours (used at night).

[0156] ② Acute phase: apply immediately when headache occurs, use continuously for 7 days each time;

[0157] Remission phase: apply every other day, continuously for 4 weeks.

[0158] ③ Contraindication management: stop using aspirin and use Yang- warming diet therapy (such as angelica ginger lamb soup).

[0159] 5) Efficacy observation

[0160] Table 4 Comparison of symptoms before and after treatment of Case Four patients

[0161] Evaluation dimension Baseline value After 4 weeks of treatment After 12 weeks of treatment MADIS pain score 70±15 35±5 20±5 Number of monthly attacks Daily attacks 10 ± 2 times 5 ± 2 times Duration of each attack 5 ± 2 hours 3 ± 1.5 hours 2 ± 1 hour Number of days of analgesic use 30 days / month 10 days / month 5 days / month

[0162] (*p <0.05, compared with baseline value. The baseline value refers to the data before treatment of the patient)

[0163] 6) Follow-up and recurrence prevention

[0164] Follow-up for 1 year: headache has not been chronicized, and has not recurred after wearing a hat during winter morning exercises.

[0165] 7) Safety evaluation

[0166] ① Skin reaction: redness of the skin, recovered to normal after 36 hours of stopping medication.

[0167] ② Blood pressure monitoring: the fluctuation range of systolic / diastolic pressure is <5 mmHg (does not affect the cardiovascular system).

[0168] ③ Liver and kidney function: no significant changes in ALT, Cr and other indicators (avoiding liver and intestinal metabolism burden).

[0169] 5, Conclusion

[0170] From the above cases, the wind- expelling and pain- relieving patch of the present application has the following effects:

[0171] ① Rapid pain relief: 30 minutes onset time is better than oral NSAIDs (average 45 minutes);

[0172] ② Prevention of recurrence: adjust the balance of CGRP / 5-HT, and block the vicious cycle of "attack-sensitization-chronification";

[0173] ③Innovation value: green de-medication, making MOH patients gradually get rid of drug dependence; cold evil targeting, through the warm yang effect of the governor vessel, specifically correcting the pathogenesis of "yang deficiency and blood stasis" of wind-cold type migraine.

[0174] In summary, the above cases demonstrate that the Qufeng Zhitong patch can provide an innovative solution for wind-cold type migraine patients with acute phase control and long-term prevention through "drug-acupoint-constitution" triple regulation.

[0175] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. For those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A wind-dispelling and pain-relieving patch for treating wind-cold type migraine, characterized in that, The raw medicinal materials include the following parts by weight: 10-20 parts of Ligusticum chuanxiong, 1-6 parts of Asarum heterotropoides, 1-6 parts of Evodia rutaecarpa, 5-13 parts of Angelica dahurica, and 1-2 parts of Borneol.

2. The wind-dispelling and pain-relieving patch for treating wind-cold type migraine according to claim 1, characterized in that, The raw medicinal materials include the following parts by weight: 12-18 parts of Ligusticum chuanxiong, 1-5 parts of Asarum heterotropoides, 1-5 parts of Evodia rutaecarpa, 7-11 parts of Angelica dahurica, and 1-2 parts of Borneol.

3. The wind-dispelling and pain-relieving patch for treating wind-cold type migraine according to claim 1, characterized in that, The raw medicinal materials include the following parts by weight: 14-16 parts of Ligusticum chuanxiong, 2-4 parts of Asarum heterotropoides, 2-4 parts of Evodia rutaecarpa, 8-10 parts of Angelica dahurica, and 1-2 parts of Borneol.

4. The wind-dispelling and pain-relieving patch for treating wind-cold type migraine according to any one of claims 1 to 3, characterized in that, The wind-dispelling and pain-relieving patch also includes pharmaceutically acceptable excipients.

5. The wind-dispelling and pain-relieving patch for treating wind-cold type migraine according to claim 4, characterized in that, The wind-dispelling and pain-relieving patch is applied to the Dazhui acupoint.

6. The application of the wind-dispelling and pain-relieving patch for treating wind-cold type migraine as described in claim 4 in the treatment of wind-cold type migraine.

7. A method for preparing the wind-dispelling and pain-relieving patch as described in claim 4, characterized in that, Includes the following steps: Step 1: Weigh the raw materials according to the weight ratio, clean, dry, cut, and mix evenly; Step 2: Place the raw materials from Step 1 into a grinder and grind them into a fine powder, then sieve them through a traditional Chinese medicine sieve. Step 3: Mix the fine powder from Step 2 with rice vinegar until it forms a paste. Then, apply the paste to sterilized non-woven fabric.

8. The preparation method according to claim 7, characterized in that, The fine powder has a particle size of 200-300 mesh.

9. The preparation method according to claim 7, characterized in that, The fine powder and the rice vinegar are mixed in a mass ratio of 1:1.5.

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