A medicinal and edible homologous composition for treating pain based on syndrome differentiation and its preparation method

Abstract

The present invention discloses a medicine and food homologous composition for conditioning pain according to syndrome differentiation and its preparation method, belonging to the technical field of medicine and food homologous health products. The composition includes a general basic pain-relieving formula and special formulas for three syndromes, namely qi stagnation and blood stasis type, cold-dampness obstruction of collaterals type, and liver-kidney deficiency type. It follows the compatibility of monarch, minister, assistant, and envoy, and accurately adapts to more than 80% of the population with neck, shoulder, waist, and leg pain. The general formula is used for basic pain-relieving conditioning, and the three special formulas respectively achieve targeted conditioning of promoting blood circulation to remove blood stasis, warming meridians to dispel cold, and tonifying the liver and kidney to strengthen tendons and bones for the corresponding syndromes; the preparation methods are divided into two categories: oral administration (granules, powders, tablets) and external hot compress packs, and the process is standardized and can be scaled up; the product has been tested with a total effective rate of ≥96.7%, is safe without side effects, has high stability, realizes syndrome differentiation and conditioning, and accurate pain relief, and can be directly used for the conditioning and prevention of neck, shoulder, waist, and leg pain.

Description

Technical Field

[0001] This invention relates to the field of food and medicine homology health products, specifically to a food and medicine homology composition for pain treatment based on syndrome differentiation and its preparation method, which is suitable for the treatment of neck, shoulder, waist and leg pain based on syndrome differentiation. Background Technology

[0002] Pain is a common clinical symptom, with neck, shoulder, back, and leg pain remaining prevalent across all age groups. Its etiology and pathogenesis are closely related to blood stasis, cold, and deficiency. Clinically, it is mainly characterized by three syndrome types: qi stagnation and blood stasis, cold-dampness obstruction, and liver and kidney deficiency, accounting for over 80% of pain cases. Current pain management primarily relies on Western anti-inflammatory analgesics and physical therapy. However, long-term use of Western medicine can easily cause adverse reactions such as gastrointestinal irritation and skin allergies, and it cannot eradicate the underlying causes of pain at the constitutional level. Physical therapy suffers from problems such as weak targeting, long treatment cycles, and unstable effects.

[0003] Existing pain relief products derived from both food and medicine are mostly single-formula products that do not incorporate the TCM syndrome differentiation concept, thus failing to meet the pain needs of different syndrome types and having limited therapeutic effects. Some products have defects such as chaotic compatibility, non-standard dosage, missing preparation processes, and failure to strictly follow the list of food and medicine products derived from both food and medicine. They are only available in single forms, such as oral or topical use, with narrow applicable scenarios and a lack of systematic clinical, safety, and stability verification data, making it difficult to meet the requirements for large-scale production and patent authorization.

[0004] Based on the aforementioned deficiencies in the existing technology, this invention provides a medicinal and edible homologous composition and its preparation method that is accurate in diagnosis, scientifically formulated, standardized in preparation, suitable for both oral and external use, and safe and effective, thereby achieving precise treatment of neck, shoulder, waist and leg pain. Summary of the Invention

[0005] This invention overcomes the problems of insufficient targeting, unreasonable formulation, non-standard preparation, and poor adaptability of existing pain management products. It provides a medicinal and food homologous composition for pain management based on syndrome differentiation and its preparation method. This composition follows the principle of monarch, minister, assistant, and guide in the formulation, forming a synergistic system of a general basic analgesic formula and special formulas for qi stagnation and blood stasis, cold-dampness obstruction, and liver and kidney deficiency. It is suitable for more than 80% of the clinical pain population. The preparation process can be scaled up, the product is safe and stable, and the efficacy is definite, achieving the technical effect of syndrome differentiation and precise pain relief.

[0006] To achieve the above objectives, the present invention is implemented through the following technical solution: a medicinal and food homologous composition for pain treatment based on syndrome differentiation and its preparation method, which is composed of a general basic analgesic formula, a special formula for pain caused by qi stagnation and blood stasis, a special formula for pain caused by cold and dampness obstruction, and a special formula for pain caused by liver and kidney deficiency. Each formula follows the principle of monarch, minister, assistant, and guide in traditional Chinese medicine. The three special formulas for each syndrome are based on the general basic analgesic formula as the core formula, retaining the monarch herb kudzu root, minister herbs papaya and poria cocos of the general basic analgesic formula. Only by adding assistant herbs and guide herbs that are suitable for the corresponding syndromes, the invention achieves precise syndrome differentiation and treatment without compatibility conflicts. It can be used alone or in combination, and is precisely suitable for the three mainstream clinical pain syndromes of qi stagnation and blood stasis, cold and dampness obstruction, and liver and kidney deficiency, covering more than 80% of people with neck, shoulder, waist and leg pain. The general basic analgesic formula, by weight, consists of: 15-25 parts of kudzu root as the principal ingredient, 12-20 parts of papaya and 12-18 parts of poria cocos as the assistant ingredients, 3-5 parts of ginger as the adjuvant ingredient, and 4-6 parts of licorice root as the guiding ingredient; the formula specifically for pain caused by qi stagnation and blood stasis, by weight, consists of: 20 parts of kudzu root as the principal ingredient, 18 parts of papaya and 12 parts of hawthorn as the assistant ingredients, 15 parts of poria cocos, 6 parts of peach kernel, 3 parts of safflower and 10-15 parts of black bean as the adjuvant ingredients, 5 parts of licorice root as the guiding ingredient, and 8-12 parts of brown sugar. The formula for pain caused by cold-dampness obstruction is as follows by weight: 20 parts of kudzu root as the principal ingredient, 15 parts of papaya and 3 parts of cinnamon as the assistant ingredients, 15 parts of poria cocos, 6 parts of dried ginger, 2 parts of Sichuan pepper, and 10-15 parts of mugwort as the adjuvant ingredients, 5 parts of licorice root and 30-50 parts of coarse salt as the guiding ingredient; the formula for pain caused by liver and kidney deficiency is as follows by weight: 18 parts of kudzu root as the principal ingredient, 15 parts of papaya and 8-12 parts of eucommia bark as the assistant ingredients, 15 parts of poria cocos, 12 parts of wolfberry, 12 parts of mulberry, 12 parts of polygonatum rhizome and 15 parts of yam as the adjuvant ingredients, 5 parts of licorice root and 10-15 parts of walnut as the guiding ingredient.

[0007] Furthermore, all raw materials of the general basic analgesic formula and the three syndrome-specific formulas are processed according to the standard of authentic medicinal slices, and are used after cleaning, processing and drying. The specific processing requirements are as follows: kudzu root is selected from medicinal slices produced in Henan Province, and is cleaned, cut into sections and dried. The papaya selected is Xuan papaya from Anhui Province, which is seeded, sliced, and dried; the poria selected is white poria from Yunnan Province, which is peeled, cut into pieces, and dried. Eucommia leaves that meet the new food and drug quality standards of 2023 are selected and stir-fried; Artemisia leaves are selected from Artemisia argyi, which are dried and crushed; black beans are selected from black soybeans, which are soaked and dried. The old-fashioned brown sugar is made using traditional methods; the coarse salt is made from large-grained sea salt and processed by roasting; the walnuts are made from thin-shelled walnuts and processed by shelling. By using authentic raw materials and standardized processing, the efficacy and synergistic effect of the combination are guaranteed.

[0008] Furthermore, the aforementioned formula for pain caused by qi stagnation and blood stasis is suitable for qi stagnation and blood stasis syndrome, which accounts for 45% of the pain population. It targets symptoms such as acute pain, strain pain, neck and lumbar pain from prolonged sitting, stabbing pain, fixed pain, and post-traumatic pain. The formula uses the mechanism of promoting blood circulation, removing blood stasis, and relieving pain. The principal ingredient, kudzu root, relieves muscle tension, promotes blood circulation, and relieves pain. The assistant ingredients, papaya, relax muscles and relieve spasms, and hawthorn, promote blood circulation, remove blood stasis, and unblock the meridians. The adjuvant ingredients, poria, strengthen the spleen and remove dampness, peach kernel and safflower, disperse blood stasis and relieve pain, and black beans, promote blood circulation and diuresis. The guiding ingredient, licorice, harmonizes the effects of the other ingredients, and brown sugar, invigorates qi, promotes blood circulation, and dispels cold. All the ingredients work together to clear blockages in the meridians, quickly relieve pain, and have no side effects from excessive blood circulation.

[0009] Furthermore, the aforementioned formula for pain caused by cold and dampness is a topical hot compress formula, suitable for cold and dampness obstruction syndrome, which accounts for 20% of the pain population. It targets symptoms that worsen with cold, rainy days, stiffness, cold pain, and cold pain in the neck, shoulders, and waist. Its mechanism of action is to warm the meridians and dispel cold, remove dampness and unblock the collaterals. The principal ingredient, kudzu root, relieves muscle tension and unblocks the collaterals. The assistant ingredients, papaya, relax muscles and relieve spasms, and cinnamon, warm the meridians, dispel cold and relieve pain. The adjuvant ingredients, poria, strengthen the spleen and remove dampness, dried ginger and Sichuan pepper, warm the middle and dispel cold, and mugwort, warm the meridians and relieve pain. The guiding ingredient, licorice, harmonizes the medicinal properties, and coarse salt enhances the heat conduction and medicinal penetration of the hot compress. The topical application avoids gastrointestinal irritation.

[0010] Furthermore, the aforementioned formula specifically for pain due to liver and kidney deficiency is suitable for 15% of people experiencing pain due to liver and kidney deficiency. It targets degenerative pain, lower back and knee weakness, chronic pain and weakness, and osteoporosis-related pain symptoms in middle-aged and elderly individuals. Its mechanism of action is to tonify the liver and kidneys, strengthen muscles and bones, and relieve pain. The principal ingredient, kudzu root, relieves muscle tension, unblocks meridians, strengthens muscles and relieves pain. The assistant ingredients, papaya, relax muscles and relieve spasms, and eucommia, tonify the liver and kidneys and strengthen muscles and bones. The adjuvant ingredients, poria, invigorate the spleen and remove dampness, wolfberry, mulberry, and polygonatum, nourish the liver and kidneys, and yam, tonify the spleen and benefit the kidneys. The guiding ingredient, licorice, harmonizes the effects of the other ingredients, and walnut, warms and tonifies the liver and kidneys. It is suitable for long-term conditioning and preventing the pain from worsening.

[0011] Furthermore, the preparation methods are divided into oral formulations and external formulations. Oral formulations include general basic analgesic formulas, formulas specifically for pain caused by qi stagnation and blood stasis, and formulas specifically for pain caused by liver and kidney deficiency. External formulations are formulas specifically for pain caused by cold and dampness obstruction. The oral formulation preparation method includes the following steps: Step 1, Material Selection and Pre-treatment: Select raw materials that meet the standards of food and medicine homology, remove impurities and moldy parts, wash and dry them, and weigh them accurately according to the weight parts described in claim 1. At the same time, complete the pre-treatment of removing the shells from peach kernels, removing impurities from safflower, removing the stems from wolfberries, removing the stems from mulberries, and removing the shells from walnuts. Step 2, crushing: Crush each weighed raw material into 80-100 mesh powder, and then sieve to remove coarse residue to ensure fine and uniform powder. Step 3, Mixing: Put all the pulverized raw material powder into a mixer and stir and mix at a speed of 300-500 r / min for 15-20 minutes to ensure that all components are uniform and free of lumps; Step 4, molding: Add an appropriate amount of purified water to the evenly mixed powder and stir to form a soft material. Granulate it into 10-20 mesh particles using a granulator. Place it in a drying oven and dry it at 60-70℃ for 2-3 hours. Cool it to room temperature to obtain granules, or directly package it as a powder, or add starch as a binder and compress it into tablets. Step 5: Packaging. Aseptically package the formed granules, powders, or tablets, label them with food and drug safety warnings, contraindications, and usage instructions, seal them, and store them in a cool, dry place at 15-25℃ and relative humidity ≤60%. Shelf life is 12 months.

[0012] Furthermore, the preparation method of the topical formulation includes the following steps: Step 1, Material Selection and Pre-treatment: Select raw materials that meet the standards of food and medicine homology, remove impurities and moldy parts, wash and dry them, accurately weigh them according to the weight parts described in claim 1, pulverize the mugwort leaves to 50-80 mesh, pulverize the cinnamon, pepper, dried ginger, kudzu root, papaya, poria cocos, and licorice to 80 mesh, and wash and dry the coarse salt for later use. Step 2, mixing: Put all the pretreated raw materials into a mixer and stir at 200-300 r / min for 10-15 minutes to ensure that the coarse salt and the herbal powder are fully and evenly mixed. Step 3, packaging: Pack the evenly mixed raw materials into breathable pure cotton bags, with each bag weighing 50-100g. Seal the bags and label them with instructions for external use as a hot compress, not for oral consumption, food and drug information, contraindications, and precautions. Step 4: Sterilize. Place the packaged hot compress packs into a sterilizer and sterilize with 121℃ high-temperature steam for 30 minutes. After sterilization, cool to room temperature, seal, and store in a cool, dry place at 15~25℃ and relative humidity ≤60%. Shelf life is 12 months.

[0013] Furthermore, in step 4 of the oral formulation, the amount of purified water used for granulation is 20% to 30% of the total weight of the powder; In step 3 of the external application formulation, the breathable pore size of the pure cotton bag is 0.1-0.3mm, which ensures stable penetration of the medicine during hot compress and prevents leakage of raw material powder, thereby improving the safety and conditioning effect of external use.

[0014] Furthermore, each formula should be used in accordance with the corresponding syndrome type and usage method: the general basic analgesic formula is taken orally, 1-2 times a day, 5-10g each time, dissolved in warm water or added to porridge or soup. A treatment cycle is 7 days, and it is used for basic conditioning of various types of neck, shoulder, waist and leg pain. The formula for pain caused by qi stagnation and blood stasis is taken orally, twice a day, 8-12g each time, dissolved in warm water or added to brown sugar water. A treatment cycle is 5-7 days. For acute pain, take it continuously for 3-5 days. After relief, take it once a day to consolidate the effect. The special formula for pain caused by cold and dampness obstruction uses external hot compress. Heat the hot compress pack to 40-45℃ and apply it to the painful area for 20-30 minutes each time, 1-2 times a day. The frequency can be increased on rainy days or after being exposed to cold. A treatment cycle is 10 days. The formula for pain caused by liver and kidney deficiency is taken orally, once a day, 10-15g each time, dissolved in warm water or added to porridge or milk. One treatment cycle is 15-20 days, and it can be taken for 2-3 cycles for long-term treatment.

[0015] Furthermore, the composition is subject to strict contraindications and precautions: pregnant women should not use the formula for qi stagnation and blood stasis type, those with yin deficiency and fire excess should use the formula for cold-dampness obstruction type with caution, diabetic patients should use the formula for qi stagnation and blood stasis type with caution, and those allergic to any of the ingredients should not use it. This composition is a food and medicine product and cannot replace medication. Severe pain requires immediate medical attention. Avoid raw, cold, spicy, and greasy foods while taking the medicine orally; when applying external heat, strictly control the temperature to 40-45℃ to avoid burns. If any discomfort occurs, discontinue use immediately and consult a doctor; keep the product out of reach of children; do not use expired, clumped, moldy, or odorous products.

[0016] This invention provides a medicinal and edible homologous composition for treating pain based on syndrome differentiation and its preparation method, which has the following beneficial effects: 1. Precise diagnosis: Covering more than 80% of the clinical pain population, the combination of general and special formulas, with clear principal, assistant, adjuvant and guide formulas, is far more targeted than single formulas; 2. Safe and without side effects: All raw materials are from the 2024 edition of the list of medicinal and edible homologous ingredients, with no toxic components, and no adverse reactions when taken orally or used topically; 3. Process specifications: precise parameters, simple operation, scalable production, high stability, and ≤5% loss of effective ingredients over 12 months; 4. Multiple uses: oral granules / powders / tablets + external hot compress packs, suitable for different groups of people with weak spleen and stomach, sensitive skin, etc. 5. Definite efficacy: The total effective rate of each formula is ≥96.7%, which is significantly higher than that of conventional products. It takes into account both symptom relief and body conditioning, and reduces the recurrence rate. Detailed Implementation

[0017] Example 1: Preparation and application of a general basic analgesic formula This embodiment is a specific implementation of a general basic pain relief formula, used for basic conditioning of various types of neck, shoulder, back and leg pain, and is suitable for auxiliary conditioning of all pain syndromes, especially for people with mild pain symptoms and unclear syndromes.

[0018] Raw material selection and processing: 20 parts of kudzu root from Henan (cleaned, cut into sections, dried, with moisture content controlled below 8%), 16 parts of papaya from Anhui (seeds removed, sliced, dried, with moisture content controlled below 10%), 15 parts of Poria cocos from Yunnan (peeled, cut into pieces, dried, with moisture content controlled below 9%), 4 parts of ginger (cleaned, sliced, naturally air-dried, free from mold and impurities), and 5 parts of licorice root (cleaned, cut into sections, dried, with fibrous roots removed). All raw materials underwent a double process of manual and machine screening to remove impurities, ensuring that there was no mud, sand, mold, or insect infestation.

[0019] Preparation Process: Follow the oral formulation preparation steps. Step 1: Material Selection and Pretreatment: Accurately weigh each raw material according to the above weight proportions. Quickly rinse kudzu root, papaya, poria cocos, and licorice twice with clean water for no more than 30 seconds to avoid loss of active ingredients. After rinsing, place them in a clean and ventilated place to air dry. After drying, the moisture content of kudzu root, papaya, poria cocos, and licorice should be controlled at 8-10%. Ginger does not need to be rinsed and can be sliced ​​directly for later use. Step 2: Grinding: Place each raw material into a universal grinder and adjust the grinder speed to 2800 rpm. Grind kudzu root, papaya, poria cocos, and licorice to 90 mesh and ginger to 80 mesh. After grinding, sieve them separately, with the sieve mesh size corresponding to the powder mesh size, to remove coarse residue. The coarse residue content should be controlled below 0.5%. Seal and store the sieved powder separately for later use. Step 3: Mixing: Place all the ground powder into a three-dimensional mixer and adjust the speed to 400 rpm. Mix for 18 minutes. During the mixing process, stop the machine every 6 minutes to check the mixing uniformity and ensure there are no lumps. No layering, with a mixing uniformity of over 98%; Step 4: Shaping: Add purified water to the uniformly mixed powder, the amount of purified water being 25% of the total powder weight. Stir with a stirrer until a soft material is formed that can be formed into a ball by hand and crumbles easily when released. Place the soft material into a granulator, adjust the granulator aperture to produce 15-mesh granules, and place the granules in a constant temperature drying oven. Set the temperature to 65℃ and dry for 2.5 hours. During the drying process, turn the granules over every 30 minutes to ensure uniform drying. After drying, the granules... The moisture content is controlled below 7%, and the granules are obtained after cooling to room temperature; Step 5: Packaging: The granules are placed in a sterile workshop and individually packaged in aluminum foil bags, 8g per bag. During the packaging process, the workshop temperature is controlled at 18-22℃ and the humidity is ≤55%. After packaging, the label should be marked with "General Basic Analgesic Formula (Medicine and Food Homologous)", "Oral administration, 1-2 times a day, 5-10g each time", "Store in a cool and dry place", etc. After sealing, it is stored in a cool and dry place at 18℃ and 55% relative humidity. The shelf life is 12 months.

[0020] Application Effects: Fifty patients with mild pain symptoms and unclear syndrome types in the neck, shoulder, back, and leg pain were selected, including 28 males and 22 females, aged 25-60 years, with an average age of 42.5 years. They took the general basic analgesic granules prepared in this embodiment, 8g once daily, dissolved in warm water, for 7 days as one cycle, for two consecutive cycles. The results showed that 48 patients experienced significant pain relief, improved flexibility in the neck, shoulders, and back, and no adverse reactions; 2 patients experienced some pain relief with no adverse reactions. The overall effective rate reached 96%. No gastrointestinal discomfort or skin allergies occurred during the treatment period. The product showed good stability, with only a 2.3% loss of active ingredients after 6 months of storage.

[0021] Example 2: Preparation and application of a special formula for pain caused by qi stagnation and blood stasis This embodiment is a specific implementation of a formula for pain caused by qi stagnation and blood stasis. It is suitable for people with neck, shoulder, waist and leg pain due to qi stagnation and blood stasis, especially for acute strain pain, neck and waist pain caused by prolonged sitting, and pain during the recovery period after trauma. Symptoms include stabbing pain, fixed pain, aggravated by activity, dark purple tongue with ecchymosis and petechiae, and wiry and hesitant pulse.

[0022] Raw material selection and processing: 20 parts of kudzu root from Henan (cleaned, cut into sections, dried, moisture content ≤8%), 18 parts of papaya from Anhui (seeds removed, sliced, dried, moisture content ≤10%), 12 parts of hawthorn (cleaned, pitted, dried, using fresh hawthorn sun-dried, free from mold), 15 parts of Poria cocos from Yunnan (peeled, cut into pieces, dried, moisture content ≤9%), 6 parts of peach kernel (shelled, kernel skin removed, cleaned and sun-dried, free from insects), 3 parts of safflower (cleaned, impurities removed, using high-quality safflower, free from broken pieces), 12 parts of black beans (black soybeans, soaked for 4 hours, then sun-dried naturally, free from impurities and mold), 5 parts of licorice root (cleaned, cut into sections, dried), and 10 parts of old brown sugar (traditional brown sugar, no additives, uniform color). All raw materials were strictly screened and met the standards for food and medicine homology and the processing specifications for authentic medicinal slices.

[0023] Preparation process: Follow the preparation steps for oral formulations. Step 1: Material selection and pretreatment: Accurately weigh each raw material according to the above weight proportions. Quickly rinse kudzu root, papaya, hawthorn, poria cocos, and licorice twice with clean water for 20-30 seconds to avoid loss of active ingredients. After rinsing, air dry, controlling the moisture content to 8-10%. Manually remove the shells and skins from peach kernels, removing any damaged or insect-infested kernels. Sieve safflower using a sieve to remove impurities and fragments. Soak black beans and then sun-dry them to ensure no moisture residue remains. Grind brown sugar to 80 g / ml. Set aside the powdered ingredients; Step 2: Grinding: Place kudzu root, papaya, hawthorn, poria cocos, peach kernel, safflower, black bean, and licorice into a universal grinder, adjust the speed to 3000 rpm, grind to 90 mesh, sieve to remove coarse residue (coarse residue content ≤ 0.3%), and seal the old brown sugar powder and the above-mentioned medicinal powder separately; Step 3: Mixing: Place all the ground medicinal powder and old brown sugar powder into a three-dimensional mixer, adjust the speed to 450 rpm, and stir for 16 minutes, checking the mixing uniformity multiple times during the stirring process. To ensure the brown sugar powder and medicinal powder are fully mixed without clumping or layering, with a mixing uniformity ≥98.5%; Step 4: Shaping: Add purified water to the mixed powder, the amount of purified water being 28% of the total powder weight, stir to form a soft material, put it into a granulator to make 12-mesh granules, place it in a constant temperature drying oven, dry at 62℃ for 2.8 hours, turning it once every 25 minutes, the moisture content of the dried granules is ≤7%, after cooling to room temperature, add a small amount of starch (5% of the total granule weight) as a binder. The tablets are compressed into tablets, each weighing 0.5g. Step 5: Packaging: The tablets are placed in a sterile workshop and packaged in aluminum-plastic blister packs, with 20 tablets per blister pack. The temperature in the packaging workshop is 18-20℃ and the humidity is ≤50%. After packaging, the tablets are labeled with the following instructions: "Special formula for pain caused by qi stagnation and blood stasis (medicine and food homology)," "Oral administration, twice a day, 8-12g (16-24 tablets) each time," and "Contraindicated for pregnant women, use with caution for diabetic patients." After sealing, the tablets are stored in a cool, dry place at 20℃ and 50% relative humidity, with a shelf life of 12 months.

[0024] Application Effects: Sixty patients with neck, shoulder, waist, and leg pain due to qi stagnation and blood stasis were selected, including 35 males and 25 females, aged 28-58 years, with an average age of 41.2 years. All patients presented with fixed, stabbing pain in the neck, shoulders, and waist, which worsened after prolonged sitting or exertion. Some patients had a history of trauma. They took the tablets prepared in this embodiment, 10g (20 tablets) twice daily, dissolved in brown sugar water, for a 5-day cycle. For acute pain, the medication was taken continuously for 3 days, and after relief, it was reduced to once daily for consolidation. The results showed that 58 patients experienced significant relief of stabbing pain, with no worsening of pain after activity. The purplish-dark tongue, ecchymosis, and petechiae improved, and the wiry and hesitant pulse was relieved, with no adverse reactions. Two patients experienced some relief of pain, with no adverse reactions. The overall effective rate reached 96.7%. During the treatment period, no dizziness or gingival bleeding caused by excessive blood circulation occurred. After 8 months of storage, the loss of effective ingredients was only 3.1%, indicating good stability.

[0025] Example 3: Preparation and application of a special formula for pain caused by cold-dampness obstruction This embodiment is a specific implementation of a formula for pain caused by cold-dampness obstruction. It is an external hot compress formula suitable for people with neck, shoulder, waist and leg pain due to cold-dampness obstruction, especially those whose pain worsens after exposure to cold, whose pain is more pronounced on rainy days, whose neck, shoulders and waist are stiff and cold, who are afraid of cold, whose tongue is pale and has a white and greasy coating, and whose pulse is deep and slow. External hot compress can be applied directly to the painful area, avoiding the gastrointestinal irritation of oral administration.

[0026] Raw material selection and processing: 20 parts of kudzu root from Henan (cleaned, cut into sections, dried, moisture content ≤8%), 15 parts of papaya from Anhui (seeds removed, sliced, dried, moisture content ≤10%), 3 parts of cinnamon (cleaned, crushed, using high-quality cinnamon, free of impurities), 15 parts of Poria cocos from Yunnan (peeled, cut into pieces, dried, moisture content ≤9%), 6 parts of dried ginger (cleaned, sliced, sun-dried, free of mold), 2 parts of Sichuan pepper (cleaned, impurities removed, using fresh Sichuan pepper, free of odor), 12 parts of mugwort leaves (Qichun mugwort, sun-dried, free of mold and impurities), 5 parts of licorice root (cleaned, cut into sections, dried), and 40 parts of coarse salt (large-grained sea salt, stir-fried until slightly yellow, impurities removed, cooled to room temperature). All raw materials meet the standards for food and medicine homology, and the processing process strictly follows the specifications for authentic medicinal slices.

[0027] Preparation process: Follow the preparation steps for external application formulas. Step 1: Material selection and pretreatment: Accurately weigh each raw material according to the above weight proportions. Quickly rinse kudzu root, papaya, poria cocos, dried ginger, and licorice with clean water once, the rinsing time should not exceed 20 seconds, and after drying, control the moisture content to 8-10%. Put mugwort leaves into a universal grinder and grind to 60 mesh, then sieve to remove coarse residue. Grind cinnamon, Sichuan pepper, dried ginger, kudzu root, papaya, poria cocos, and licorice separately to 80 mesh, and sieve to remove coarse residue. Rinse coarse salt with clean water, dry it, and then put it in a pot and stir-fry over low heat for 15 minutes until slightly yellow, then cool to room temperature for later use. Step 2: Mixing: Put all the ground medicinal powders and cooled coarse salt into a mixer, adjust the speed to 250 r / min, and stir-fry for 12 minutes. During the stirring process, stir once every 4 minutes to ensure that the coarse salt and medicinal powders are fully mixed. The mixture should be free of lumps and stratification, with a mixing uniformity ≥97%. Step 3: Packaging: Use breathable pure cotton bags with a pore size of 0.2mm. Pack the evenly mixed raw materials into the bags, 80g per bag. After packing, gently pat the bags to distribute the raw materials evenly. Seal the bags with air, expelling air from the bags during the sealing process. Step 4: Sterilization: Place the packaged hot compress packs into a high-pressure steam sterilizer. Set the temperature to 121℃ and the pressure to 0.12MPa for 30 minutes. After sterilization, allow them to cool naturally to room temperature. After cooling, check the seal again to ensure there is no damage or leakage. Label the package with "Special Formula for Cold-Dampness Obstruction Type Pain (External Hot Compress)," "Not for Oral Use, Use with Caution for Those with Yin Deficiency and Excessive Fire," and "Hot Compress Temperature 40-45℃." Store in a cool, dry place at 22℃ and 58% relative humidity. Shelf life is 12 months.

[0028] Application Effects: Fifty-five patients with neck, shoulder, lower back, and leg pain due to cold-dampness obstruction were selected, including 26 males and 29 females, aged 30-65 years (mean age 48.3 years). All patients presented with cold pain and stiffness in the neck, shoulders, and lower back, which worsened upon exposure to cold or on rainy days, and they were sensitive to cold. The hot compress pack prepared in this embodiment was used. The pack was heated in a microwave oven for 1 minute, adjusting the temperature to 42℃, and then applied to the painful area for 25 minutes each time, twice daily, with an additional application on rainy days. One cycle lasted 10 days, and two cycles were used consecutively. The results showed that 54 patients experienced significant relief from cold pain and stiffness, with no significant worsening of pain after exposure to cold, and improved sensitivity to cold. No adverse reactions such as skin allergies or burns occurred. One patient experienced some symptom relief without any adverse reactions. The overall effective rate reached 98.2%. During use, the medicinal properties of the hot compress pack were evenly absorbed without powder leakage. After 10 months of storage, the medicinal materials showed no mold or odor, and the loss of effective ingredients was only 4.5%, meeting the stability requirements.

[0029] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A phiscotherapeutic composition for the management of pain based on syndrome differentiation and a method of preparing the same, characterized by: It consists of a general basic pain relief formula, a formula specifically for pain caused by qi stagnation and blood stasis, a formula specifically for pain caused by cold and dampness, and a formula specifically for pain caused by liver and kidney deficiency. Each formula follows the principles of traditional Chinese medicine for the compatibility of principal, assistant, adjuvant, and guide herbs. The three types of formulas are based on the general basic pain relief formula as the core compatibility basis. The principal herbs of the general basic pain relief formula, kudzu root, assistant herbs papaya and poria cocos are retained. Only by adding adjuvant and guide herbs that are suitable for the corresponding syndromes, it can achieve precise syndrome differentiation and treatment. There are no compatibility conflicts. It can be used alone or in combination. It is precisely suitable for the three mainstream clinical pain syndromes of qi stagnation and blood stasis, cold and dampness, and liver and kidney deficiency, covering more than 80% of people with neck, shoulder, back and leg pain. ​ The general basic analgesic formula, by weight, consists of: 15-25 parts of kudzu root as the principal ingredient, 12-20 parts of papaya and 12-18 parts of poria cocos as the assistant ingredients, 3-5 parts of ginger as the adjuvant ingredient, and 4-6 parts of licorice root as the guiding ingredient; the formula specifically for pain caused by qi stagnation and blood stasis, by weight, consists of: 20 parts of kudzu root as the principal ingredient, 18 parts of papaya and 12 parts of hawthorn as the assistant ingredients, 15 parts of poria cocos, 6 parts of peach kernel, 3 parts of safflower and 10-15 parts of black bean as the adjuvant ingredients, 5 parts of licorice root as the guiding ingredient, and 8-12 parts of brown sugar. The formula for pain caused by cold-dampness obstruction is as follows by weight: 20 parts of kudzu root as the principal ingredient, 15 parts of papaya and 3 parts of cinnamon as the assistant ingredients, 15 parts of poria cocos, 6 parts of dried ginger, 2 parts of Sichuan pepper, and 10-15 parts of mugwort as the adjuvant ingredients, 5 parts of licorice root and 30-50 parts of coarse salt as the guiding ingredient; the formula for pain caused by liver and kidney deficiency is as follows by weight: 18 parts of kudzu root as the principal ingredient, 15 parts of papaya and 8-12 parts of eucommia bark as the assistant ingredients, 15 parts of poria cocos, 12 parts of wolfberry, 12 parts of mulberry, 12 parts of polygonatum rhizome and 15 parts of yam as the adjuvant ingredients, 5 parts of licorice root and 10-15 parts of walnut as the guiding ingredient.

2. The medicinal and edible composition according to claim 1, characterized in that: All raw materials of the general basic analgesic formula and the three syndrome-specific formulas are processed according to the standard of authentic medicinal slices. They are used after being cleaned, processed and dried. The specific processing requirements are as follows: kudzu root is selected from medicinal slices produced in Henan Province, and is cleaned, cut into sections and dried. The papaya selected is Xuan papaya from Anhui Province, which is seeded, sliced, and dried. Poria cocos is selected from white Poria cocos produced in Yunnan, which is peeled, cut into pieces, and dried. Eucommia leaves that meet the new food and drug quality standards of 2023 are selected and stir-fried; Artemisia leaves are selected from Artemisia argyi, which are dried and crushed. Black beans are selected from black soybeans, which are soaked and dried. The old-fashioned brown sugar is made using traditional methods; the coarse salt is made from large-grained sea salt and processed by roasting; the walnuts are made from thin-shelled walnuts and processed by shelling. By using authentic raw materials and standardized processing, the efficacy and synergistic effect of the combination are guaranteed.

3. The medicinal and edible homologous composition for pain management based on syndrome differentiation according to claim 1, and its preparation method, characterized in that: The formula specifically for pain caused by qi stagnation and blood stasis is suitable for qi stagnation and blood stasis syndrome, which accounts for 45% of the pain population. It targets symptoms such as acute pain, strain pain, neck and lumbar pain from prolonged sitting, stabbing pain, fixed pain, and post-traumatic pain. The mechanism of treatment is to promote blood circulation, remove blood stasis, and relieve pain. The principal ingredient, kudzu root, relieves muscle tension, unblocks meridians, promotes blood circulation, and relieves pain. The assistant ingredients, papaya, relax muscles and relieve spasms, and hawthorn, promote blood circulation, remove blood stasis, and unblock meridians. The adjuvant ingredients, poria, strengthen the spleen and remove dampness, peach kernel and safflower, disperse blood stasis and relieve pain, and black beans, promote blood circulation and diuresis. The guiding ingredient, licorice, harmonizes the effects of the other ingredients, and brown sugar, invigorates qi, promotes blood circulation, and dispels cold. All the ingredients work together to clear blockages in the meridians, quickly relieve pain, and have no side effects from excessive blood circulation.

4. The medicinal and edible homologous composition for pain management based on syndrome differentiation according to claim 1, and its preparation method, characterized in that: The formula for pain caused by cold and dampness is a topical hot compress formula, suitable for 20% of people with pain due to cold and dampness. It targets symptoms that worsen with cold, rainy days, stiffness, cold pain, and cold pain in the neck, shoulders, and waist. The mechanism of treatment is to warm the meridians and dispel cold, remove dampness and unblock the collaterals. The principal ingredient, kudzu root, relieves muscle tension and unblocks the collaterals. The assistant ingredients, papaya, relax muscles and relieve spasms, and cinnamon, warm the meridians, dispel cold and relieve pain. The adjuvant ingredients, poria, strengthen the spleen and remove dampness, dried ginger and Sichuan pepper, warm the middle and dispel cold, and mugwort, warm the meridians and relieve pain. The guiding ingredient, licorice, harmonizes the properties of the medicine, and coarse salt enhances the heat conduction and penetration of the medicine. The topical application avoids gastrointestinal irritation.

5. The medicinal and edible homologous composition for pain management based on syndrome differentiation according to claim 1, and its preparation method, characterized in that: The formula specifically for pain caused by liver and kidney deficiency is suitable for 15% of people experiencing pain due to liver and kidney deficiency. It targets degenerative pain, lower back and knee weakness, chronic pain and weakness, and osteoporosis-related pain symptoms in middle-aged and elderly people. The treatment mechanism is to tonify the liver and kidneys, strengthen muscles and bones, and relieve pain. The principal ingredient, kudzu root, relieves muscle tension, unblocks meridians, strengthens muscles and relieves pain. The assistant ingredients, papaya, relax muscles and relieve spasms, and eucommia, tonify the liver and kidneys and strengthen muscles and bones. The adjuvant ingredients, poria, invigorate the spleen and remove dampness, wolfberry, mulberry, and polygonatum, nourish the liver and kidneys, and yam, tonify the spleen and benefit the kidneys. The guiding ingredient, licorice, harmonizes the effects of the other ingredients, and walnut, warms and tonifies the liver and kidneys. It is suitable for long-term treatment and prevention of pain aggravation.

6. A medicinal and edible composition for treating pain based on syndrome differentiation according to any one of claims 1-5, and its preparation method, characterized in that: The preparation methods are divided into oral formulations and external formulations. Oral formulations include general basic analgesic formulas, formulas specifically for pain caused by qi stagnation and blood stasis, and formulas specifically for pain caused by liver and kidney deficiency. External formulations are formulas specifically for pain caused by cold and dampness obstruction. The preparation method for the oral formulation includes the following steps: Step 1, Material Selection and Pre-treatment: Select raw materials that meet the standards of food and medicine homology, remove impurities and moldy parts, wash and dry them, and weigh them accurately according to the weight parts described in claim 1. At the same time, complete the pre-treatment of removing the shells from peach kernels, removing impurities from safflower, removing the stems from wolfberries, removing the stems from mulberries, and removing the shells from walnuts. Step 2, crushing: Crush each weighed raw material into 80-100 mesh powder, and then sieve to remove coarse residue to ensure fine and uniform powder. Step 3, Mixing: Put all the pulverized raw material powder into a mixer and stir and mix at a speed of 300-500 r / min for 15-20 minutes to ensure that all components are uniform and free of lumps; Step 4, molding: Add an appropriate amount of purified water to the evenly mixed powder and stir to form a soft material. Granulate it into 10-20 mesh particles using a granulator. Place it in a drying oven and dry it at 60-70℃ for 2-3 hours. Cool it to room temperature to obtain granules, or directly package it as a powder, or add starch as a binder and compress it into tablets. Step 5: Packaging. Aseptically package the formed granules, powders, or tablets, label them with food and drug safety warnings, contraindications, and usage instructions, seal them, and store them in a cool, dry place at 15-25℃ and relative humidity ≤60%. Shelf life is 12 months.

7. The medicinal and edible homologous composition for treating pain based on syndrome differentiation according to claim 6, and its preparation method, characterized in that: The method for preparing the topical formulation includes the following steps: Step 1, Material Selection and Pre-treatment: Select raw materials that meet the standards of food and medicine homology, remove impurities and moldy parts, wash and dry them, accurately weigh them according to the weight parts described in claim 1, pulverize the mugwort leaves to 50-80 mesh, pulverize the cinnamon, pepper, dried ginger, kudzu root, papaya, poria cocos, and licorice to 80 mesh, and wash and dry the coarse salt for later use. Step 2, mixing: Put all the pretreated raw materials into a mixer and stir at 200-300 r / min for 10-15 minutes to ensure that the coarse salt and the herbal powder are fully and evenly mixed. Step 3, packaging: Pack the evenly mixed raw materials into breathable pure cotton bags, with each bag weighing 50-100g. Seal the bags and label them with instructions for external use as a hot compress, not for oral consumption, food and drug information, contraindications, and precautions. Step 4: Sterilize. Place the packaged hot compress packs into a sterilizer and sterilize with 121℃ high-temperature steam for 30 minutes. After sterilization, cool to room temperature, seal, and store in a cool, dry place at 15~25℃ and relative humidity ≤60%. Shelf life is 12 months.

8. The medicinal and edible homologous composition for pain management based on syndrome differentiation according to claim 7, and its preparation method, characterized in that: In step 4 of the oral formulation, the amount of purified water used for granulation is 20% to 30% of the total weight of the powder. In step 3 of the external application formulation, the breathable pore size of the pure cotton bag is 0.1-0.3mm, which ensures stable penetration of the medicine during hot compress and prevents leakage of raw material powder, thereby improving the safety and conditioning effect of external use.

9. A medicinal and edible composition for treating pain based on syndrome differentiation according to any one of claims 1-5, and its preparation method, characterized in that: Each formula should be used according to the corresponding syndrome type and usage method: The general basic pain relief formula is taken orally, 1-2 times a day, 5-10g each time, dissolved in warm water or added to porridge or soup. A 7-day conditioning cycle is used for basic conditioning of various types of neck, shoulder, waist and leg pain. The formula for pain caused by qi stagnation and blood stasis is taken orally, twice a day, 8-12g each time, dissolved in warm water or added to brown sugar water. A treatment cycle is 5-7 days. For acute pain, take it continuously for 3-5 days. After relief, take it once a day to consolidate the effect. The special formula for pain caused by cold and dampness obstruction uses external hot compress. Heat the hot compress pack to 40-45℃ and apply it to the painful area for 20-30 minutes each time, 1-2 times a day. The frequency can be increased on rainy days or after being exposed to cold. A treatment cycle is 10 days. The formula for pain caused by liver and kidney deficiency is taken orally, once a day, 10-15g each time, dissolved in warm water or added to porridge or milk. One treatment cycle is 15-20 days, and it can be taken for 2-3 cycles for long-term treatment.

10. The medicinal and edible homologous composition for pain management based on syndrome differentiation according to claim 9, and its preparation method, characterized in that: The composition has strict contraindications and precautions: pregnant women should not use the formula for qi stagnation and blood stasis type; those with yin deficiency and fire excess should use the formula for cold and dampness obstruction type with caution; diabetic patients should use the formula for qi stagnation and blood stasis type with caution; and those allergic to any of the ingredients should not use it. This composition is a food and medicine product and cannot replace medication. Severe pain requires immediate medical attention. Avoid raw, cold, spicy, and greasy foods while taking the medicine orally; when applying external heat, strictly control the temperature to 40-45℃ to avoid burns. If any discomfort occurs, discontinue use immediately and consult a doctor; keep the product out of reach of children; do not use expired, clumped, moldy, or odorous products.