Nine kinds of physique cold and heat differentiation of the same source of medicinal paste and its preparation method

Abstract

The present application relates to a medicine-food homologous paste based on nine kinds of body constitution cold and heat differentiation taste correction and a preparation method thereof, belonging to the field of functional food. According to the nine kinds of body constitution classification standard of traditional Chinese medicine, the exclusive formula is designed for nine kinds of body constitution, including normal, qi deficiency, yang deficiency, yin deficiency, phlegm-damp, damp-heat, blood stasis, qi depression and special constitution, the raw materials of traditional Chinese medicine involved are the raw materials of medicine-food homology published by the National Health Commission of China, without adding artificial essence, pigment, sucrose and chemical preservative. And the amount of honey is adjusted according to the cold and heat property difference of each body constitution. During preparation, the raw materials are extracted by low-temperature ultrasonic, filtered and clarified, concentrated under reduced pressure and low temperature, then honey is added for adjustment, and the finished product is obtained after pasteurization, the whole process of extraction and concentration is temperature-controllable, which effectively retains the heat-sensitive active ingredients such as polysaccharide and flavonoids. The formula is highly targeted, the taste is natural and pure, there is no artificial additive, the product has good stability, the shelf life at room temperature is not less than 18 months, and the process is mature and suitable for industrialized mass production.

Description

Technical Field

[0001] This invention relates to the field of functional food technology, specifically to a medicinal and edible paste with flavoring based on the differences in cold and heat constitutions among nine different body types, and its preparation method. Background Technology

[0002] The identification of nine constitutions in Traditional Chinese Medicine (TCM) is the core theoretical foundation for the research and development of health-preserving products based on the principle of food and medicine sharing the same origin. The industry standardization system is gradually improving: First, T / HSIPA 004-2022, "Technical Guidelines for TCM Constitution-Based Health-Preserving Paste Formulas," was released, clarifying the principles, compatibility framework, and general technical requirements for the development of paste formulas corresponding to the nine constitutions. Subsequently, T / CRACM 0003—2025, "Standard for TCM Constitution-Based Food and Medicine Paste Formulas," was issued, further standardizing the formula matching rules, raw material quality control, processing technology, and finished product quality indicators for constitution-based paste formulas, providing a technical basis for the industrialization of constitution-based pastes. Based on this, the national standard GB / T 46939—2025, "Classification and Determination of TCM Constitutions," was officially released, classifying human constitutions into nine types: balanced, qi-deficient, yang-deficient, yin-deficient, phlegm-dampness, damp-heat, blood stasis, qi stagnation, and special constitution. This standard will be implemented on April 1, 2026, providing a unified national standard for the precise research and development of constitution-based dietary therapy products. With the continuous integration of traditional Chinese medicine constitution theory and functional dietary foods, medicinal and edible paste products developed based on nine constitutions are rapidly gaining popularity. Two group standards and one national standard together constitute a complete technical system, greatly expanding the market application scenarios of constitution-based pastes, while also raising higher industry requirements for the scientific nature of formula differentiation, the compliance of raw materials with medicinal and edible origins, the standardization of production processes, and the design of clean label formulas.

[0003] However, current mainstream liquid-based ointment products still suffer from numerous technical defects. Firstly, there is a serious problem of formula homogenization. Most products use a uniform formula or only slightly adjust individual components, failing to systematically differentiate and combine ingredients according to the cold / heat and deficiency / excess characteristics of the nine body constitutions, resulting in insufficient targeting and precision in health maintenance. Secondly, taste improvement relies excessively on exogenous additives such as sucrose, artificial flavors, and colorings. While some products use honey to improve flavor, they do not differentiate the proportions based on the cold / heat attributes of the body constitution—for those with a warm constitution, it may feel cloying and damp, while for those with a cold constitution, it is difficult to effectively mask the bitter taste of the raw materials, limiting the target audience. Thirdly, traditional ointments often employ a high-temperature, long-term boiling process under normal pressure. The high heating temperature, long time, and poor uniformity not only lead to the significant degradation and loss of heat-sensitive active ingredients such as polysaccharides and flavonoids within the ointment but also easily produce a burnt odor, severely affecting product quality. Fourth, some products use non-food and medicine homology raw materials or add exogenous excipients such as starch and dextrin, which poses compliance risks and potential allergen hazards, making it difficult to meet the development trend of clean labeling. A search of domestic patents, academic literature, and industry standards has not yet revealed a technical solution that uses the nine body constitutions' hot and cold attributes as the core, relies on honey to achieve natural differentiated flavoring, and employs a low-temperature process throughout the entire process to prepare food and medicine homology ointments. Summary of the Invention

[0004] In order to solve the problems of the prior art, this invention provides a medicinal and edible paste with flavoring based on the differences in cold and heat in nine body constitutions and its preparation method.

[0005] To solve the above-mentioned technical problems, the present invention is achieved through the following technical solution: Firstly, a medicinal and edible paste based on the differentiating cold and heat properties of nine body constitutions is composed of formulas corresponding to the nine constitutions, using honey as a natural flavoring agent, and containing no artificial flavors, colorings, sucrose, or chemical preservatives; the specific formula of each component by weight is as follows: Balanced constitution: 19-21 parts yam, 11-13 parts lotus seed, 11-13 parts poria cocos, 11-13 parts wolfberry, 11-13 parts fox nut, 2-3 parts licorice, 9-11 parts honey; Qi deficiency constitution: Astragalus membranaceus 21-27 parts, Dioscorea opposita 19-21 parts, Poria cocos 11-13 parts, Codonopsis pilosula 10-12 parts, Jujube 15-17 parts, Longan 7-9 parts, Licorice 2-3 parts, Honey 7-9 parts; Yang deficiency constitution: 8-9 parts dried ginger, 19-21 parts yam, 11-13 parts poria cocos, 11-13 parts wolfberry, 15-17 parts red dates, 10-12 parts alpinia oxyphylla, 9-11 parts raspberry, 6-8 parts desert cistanche, 10-12 parts codonopsis pilosula, 2-3 parts licorice, 7-9 parts honey; Yin deficiency constitution: Polygonatum odoratum 15-17 parts, Ophiopogon japonicus 15-17 parts, Lilium brownii 10-12 parts, Tremella fuciformis 10-12 parts, Lycium barbarum 11-13 parts, dried pear 15-17 parts, Glycyrrhiza uralensis 2-3 parts, honey 10-12 parts; Phlegm-dampness constitution: 21-27 parts of coix seed, 12-15 parts of poria cocos, 8-9 parts of dried tangerine peel, 10-12 parts of hawthorn, 5-7 parts of lotus leaf, 2-3 parts of licorice root, and 8-10 parts of honey; Damp-heat constitution: Chrysanthemum 7-9 parts, red bean 15-17 parts, coix seed 21-27 parts, honeysuckle 6-8 parts, lotus leaf 5-7 parts, licorice 2-3 parts, honey 7-9 parts; Blood stasis constitution: 15-17 parts hawthorn, 7-8 parts peach kernel, 10-12 parts angelica, 15-17 parts red dates, 8-12 parts rose, 2-3 parts licorice, 8-10 parts honey; Qi stagnation constitution: 10-12 parts rose petals, 8-10 parts Buddha's hand citron, 8-10 parts citron, 8-9 parts dried tangerine peel, 15-17 parts malt, 2-3 parts licorice root, and 8-10 parts honey; Special constitution: 19-21 parts of yam, 11-13 parts of lotus seed, 10-12 parts of lily bulb, 11-13 parts of poria cocos, 8-9 parts of perilla leaf, 2-3 parts of licorice root, and 8-10 parts of honey.

[0006] In one specific implementation of the first aspect, all the Chinese medicinal materials involved are items that are both food and medicine as announced by the National Health Commission.

[0007] In one specific implementation of the first aspect, the product is stored at room temperature in a sealed container, with a shelf life of ≥18 months, and there are no phenomena such as stratification, sand return, discoloration, or odor during storage.

[0008] Secondly, a method for preparing a medicinal and edible paste based on the differentiating cold and heat properties of nine different body constitutions includes the following steps: Step 1: Raw material pretreatment: Clean and remove impurities from the raw materials in the formula, and crush them to 20-40 mesh for later use; Step 2: Low-temperature ultrasonic extraction: Add purified water to the raw material, control the material-to-liquid ratio at 1:10 to 1:15, ultrasonic temperature at 45 to 55°C, ultrasonic power density at 15 to 25 W / L, extraction time at 60 to 90 min, and collect all the extract. Step 3: The extract is coarsely filtered through a 200-mesh filter to remove solid residue; Step 4: Low-pressure concentration: Place the coarse filtrate in a low-pressure concentration device with a vacuum degree of -0.07 to -0.09 MPa and a concentration temperature of 55 to 65°C. When the concentration reaches 55°C, the relative density is measured to be 1.25 to 1.32, resulting in a thick concentrated paste. Step 5: Mix and homogenize: Add the corresponding weight of honey to the concentrated paste and stir thoroughly until well mixed; Step 6: Filling and sterilization: The prepared paste is aseptically filled and sterilized using pasteurization at a temperature of 68-73℃ for 18-22 minutes. After cooling, it is sealed and packaged to obtain the finished product.

[0009] In one specific implementation of the second aspect, the temperature during the entire extraction and concentration process does not exceed 65°C.

[0010] In one specific embodiment of the second aspect, the honey mentioned in step 5 is the honey weight portion corresponding to the body constitution formula in claim 1.

[0011] In one specific embodiment of the second aspect, the ultrasonic temperature of the low-temperature ultrasonic extraction in step 2 is 50°C, the ultrasonic power density is 20W / L, and the extraction time is 75min.

[0012] In one specific embodiment of the second aspect, the vacuum degree of the reduced pressure cryogenic concentration in step 4 is -0.08 MPa, and the concentration temperature is 60°C.

[0013] In one specific embodiment of the second aspect, the pasteurization in step 6 is performed at a sterilization temperature of 70°C for a sterilization time of 20 minutes.

[0014] The beneficial effects of this invention are as follows: 1. This invention is based on the nine constitution classification standards of Traditional Chinese Medicine. It designs exclusive formulas for each of the nine constitutions—balanced, qi-deficient, yang-deficient, yin-deficient, phlegm-dampness, damp-heat, blood stasis, qi stagnation, and special constitution—each with its own unique pathogenesis characteristics. This achieves precise compatibility of "nine formulas for nine constitutions," ensuring a high degree of match between the synergistic effects of the medicinal and edible components in each formula and the corresponding constitution's conditioning needs. Furthermore, this invention breaks through the conventional practice of uniformly adjusting the taste in existing technologies. It adjusts the amount of honey according to the differences in the cold / heat and deficiency / excess attributes of each constitution, allowing the sweet and moistening properties of honey to complement the overall cold / heat bias of the formula. For cold constitutions paired with warming ingredients, honey is appropriately increased to neutralize the warming and dryness of the ingredients and improve the taste; for warm constitutions paired with cooling ingredients, honey is appropriately reduced to avoid cloying or stomach upset. This achieves a unity between natural taste adjustment and constitution suitability. In addition, the raw materials of Chinese medicinal herbs in the formula are all food and medicine homologous items announced by the National Health Commission. Honey is used as the only flavoring agent. No artificial flavors, colorings, sweeteners and chemical preservatives are added. While ensuring the natural and pure flavor of the product, the safety risks and unpleasant taste that may be caused by exogenous additives are eliminated, so that the clean label attributes of the product and the suitability for the body are taken into account. 2. This invention abandons the traditional high-temperature, long-term simmering process of traditional Chinese medicine pastes, and adopts a fully integrated low-temperature preparation scheme combining low-temperature ultrasonic extraction and low-temperature vacuum concentration. Low-temperature ultrasonic extraction utilizes the cavitation effect and mechanical vibration of ultrasound to efficiently break down plant cell walls at lower temperatures, promoting the full dissolution of heat-sensitive active ingredients such as polysaccharides and flavonoids, while avoiding degradation caused by high temperatures. Low-temperature vacuum concentration reduces system pressure, allowing the solvent to evaporate rapidly at lower temperatures. The concentration process is gentle and controllable, effectively avoiding the thermal damage to active ingredients and the generation of burnt odors caused by high-temperature concentration under normal pressure, thus ensuring a high retention rate of active ingredients and pure flavor in the final product. After concentration, honey is added for blending, followed by low-temperature pasteurization. This effectively kills microorganisms while avoiding the damage to heat-sensitive components and honey enzymes caused by high-temperature sterilization, preserving the natural sensory qualities of the paste, such as color, aroma, and taste. The synergistic effect of the above-mentioned process steps results in a uniform and stable semi-fluid state in the finished paste, preventing quality deterioration such as stratification, sanding, discoloration, and off-odors during storage, and effectively ensuring the physicochemical stability of the product throughout its shelf life. This invention features a scientifically formulated, mature process with clearly defined parameter ranges. The entire process utilizes common equipment in the food processing field, making it easy to operate, energy-efficient, and highly reproducible between batches, thus possessing excellent adaptability for continuous industrial production. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the process flow of the present invention. Detailed Implementation

[0016] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0017] like Figure 1 The image shows a medicinal and edible paste with flavoring based on the differences in cold and heat constitutions among nine different body types, and its preparation method.

[0018] I. Overview of Technical Solution This invention provides a medicinal and edible paste with differentiated flavoring based on nine body constitutions (cold and hot), and its preparation method. This invention classifies human constitutions into nine types: balanced, qi deficiency, yang deficiency, yin deficiency, phlegm-dampness, damp-heat, blood stasis, qi stagnation, and special constitution. A customized formula is designed for each of these nine constitutions, using honey as a natural flavoring agent to achieve differentiated flavor blending.

[0019] The raw materials of the ointment of this invention are all Chinese medicinal materials that are listed by the National Health Commission as both food and medicine. The unit of each component in the formula is part by weight, which represents the relative weight ratio between the components. In the following specific embodiment, 1 part by weight = 1g. Industrial production can be scaled up proportionally.

[0020] II. Detailed breakdown of preparation methods 2.1 Raw material pretreatment After weighing the raw materials for each constitution formula, place them in a cleaning device and rinse with flowing purified water to remove surface mud and impurities. Place the cleaned raw materials in an oven and dry them at 40–50°C for 2–4 hours, removing the moisture introduced during cleaning. Then, put the dried raw materials into a pulverizer and pulverize them, passing them through a 20–40 mesh sieve. Collect the sieve-passing material for later use.

[0021] Input: Ingredients for each body type formula (by weight).

[0022] Output: 20-40 mesh raw material powder.

[0023] Control parameters: drying temperature 40-50℃, drying time 2-4h, pulverized particle size 20-40 mesh.

[0024] 2.2 Low-temperature ultrasonic extraction The pretreated raw material powder is placed into an ultrasonic extraction vessel, and purified water (preferably 1:12) is added at a material-to-liquid ratio of 1:10 to 1:15. The ultrasonic generator is turned on, and the ultrasonic temperature is set to 45–55℃ (preferably 50℃), the ultrasonic power density to 15–25 W / L (preferably 20 W / L), and the extraction time to 60–90 min (preferably 75 min). During the extraction process, the mixture is slowly stirred with a stirrer at a speed of 30–60 r / min to ensure full contact between the raw material and the water. After extraction, all the extract is collected.

[0025] The principle of ultrasonic extraction lies in the cavitation, mechanical, and thermal effects generated by ultrasound in liquids, which effectively disrupt plant cell walls and promote the dissolution of intracellular active ingredients. Compared to traditional high-temperature decoction, the low-temperature ultrasonic extraction method used in this invention achieves highly efficient extraction at lower temperatures, avoiding the degradation of heat-sensitive components. The parameter range of 45–55℃ for ultrasonic temperature and 15–25 W / L for ultrasonic power density was determined through single-factor and orthogonal experiments. Under these conditions, the extraction rate of active ingredients such as polysaccharides and flavonoids can reach 1.5–2.0 times that of traditional decoction methods, while the extraction temperature does not exceed 55℃ throughout the process, effectively protecting heat-sensitive active ingredients.

[0026] Input: 20-40 mesh raw material powder, purified water.

[0027] Output: Extract (a suspension containing water-soluble active ingredients).

[0028] Control parameters: material-to-liquid ratio 1:10 to 1:15, ultrasonic temperature 45 to 55℃, ultrasonic power density 15 to 25 W / L, extraction time 60 to 90 min, stirring speed 30 to 60 r / min.

[0029] 2.3 Coarse Filtration The collected extract was coarsely filtered through a 200-mesh stainless steel sieve to remove larger solid particles such as plant tissue residue.

[0030] Input: Extract.

[0031] Output: Clarified filtrate.

[0032] Control parameters: 200 mesh coarse filter.

[0033] 2.4 Reduced-Pressure Low-Temperature Concentration The clarified filtrate is fed into a vacuum concentration apparatus (such as a rotary evaporator or scraped plate concentrator), with the vacuum level set to -0.07 to -0.09 MPa (preferably -0.08 MPa) and the concentration temperature set to 55 to 65°C (preferably 60°C). Under reduced pressure, the boiling point of water decreases, allowing for rapid concentration at a lower temperature. The relative density of the liquid is continuously monitored during concentration. When the relative density measured at 55°C is 1.25 to 1.32, concentration is stopped, yielding a concentrated paste.

[0034] It is important to note that the temperature throughout the extraction and concentration process does not exceed 65℃. This temperature control is one of the core key aspects of the process in this invention. Traditional herbal paste preparation typically involves high-temperature boiling at normal pressure, with temperatures reaching over 100℃, which leads to significant degradation of heat-sensitive active ingredients such as polysaccharides and flavonoids. Studies show that for every 5℃ increase in the final paste temperature, the degradation rate of polysaccharides increases by approximately 15%. This invention, through low-temperature (≤65℃) processing throughout the entire process, achieves a polysaccharide retention rate of over 90% and a flavonoid retention rate of over 85%.

[0035] Input: Clarified filtrate.

[0036] Output: Concentrated paste (relative density measured at 55℃: 1.25~1.32).

[0037] Control parameters: vacuum degree -0.07~-0.09MPa, concentration temperature 55~65℃, final relative density 1.25~1.32 (measured at 55℃).

[0038] 2.5 Mixing and homogenizing Add the prescribed weight of honey according to the body type formula to the concentrated paste, turn on the homogenizer and stir at a speed of 50-70 r / min for 15-30 minutes to ensure that the honey and concentrated paste are fully mixed.

[0039] The amount of honey added is differentiated according to the individual's constitution (whether it is cold or hot): For those with a cold constitution (such as those with Yang deficiency or Qi deficiency), the amount of honey should be increased to neutralize the warming and drying properties of the ingredients and improve the taste; for those with a warm constitution (such as those with damp-heat), the amount of honey should be reduced to avoid being too rich and causing dampness; for those with Yin deficiency, the amount of honey should be the highest (10-12 parts) because it needs to moisturize dryness and nourish Yin. Honey is not only used as a flavoring agent, but its fructose, glucose, and various enzymes also have certain nutritional value and health benefits.

[0040] Input: concentrated paste, honey.

[0041] Output: A well-mixed paste.

[0042] Control parameters: stirring speed 50-70 r / min, stirring time 15-30 min.

[0043] 2.6 Filling and Sterilization The prepared paste is filled into cleaned and sterilized glass bottles using an aseptic filling machine. The filling amount per bottle can be set to 100g, 150g, 200g, or 300g, depending on market demand. Immediately after filling, pasteurization is performed at a temperature of 68–73℃ (preferably 70℃) for 18–22 minutes (preferably 20 minutes). After sterilization, the mixture is gradually cooled to room temperature, the seal is checked, and after labeling, the finished product is obtained.

[0044] The pasteurization temperature setting of 68-73℃ balances sterilization effectiveness with the protection of active ingredients: within this temperature range, pathogenic and spoilage bacteria in the paste can be effectively killed, keeping the total bacterial count ≤1000 CFU / g, coliform bacteria ≤0.3 MPN / g, and molds and yeasts ≤50 CFU / g; at the same time, the sterilization temperature is below 73℃, avoiding the destruction of enzymes and active ingredients in honey and paste by high temperature.

[0045] Input: Mixed paste, glass bottle.

[0046] Output: Finished ointment.

[0047] Control parameters: sterilization temperature 68-73℃, sterilization time 18-22min.

[0048] III. Product Quality Control Methods The quality control of the ointment of this invention includes the following testing items and methods: 1. Physical properties inspection: Visually observe the color and shape of the paste, smell it, and taste it. A qualified product should be a uniform semi-fluid paste with the corresponding color and odor for each body type formula, and should not have a burnt or off-odor.

[0049] 2. Determination of relative density: Refer to the method in the general chapter of Part IV of the Chinese Pharmacopoeia, take an appropriate amount of the test sample, and measure the relative density at 55℃. It should be 1.25 to 1.32.

[0050] 3. Microbial limit test: Performed in accordance with GB 4789 series standards. Total bacterial count ≤1000 CFU / g, coliform bacteria ≤0.3 MPN / g, molds and yeasts ≤50 CFU / g, and pathogenic bacteria such as Salmonella and Staphylococcus aureus must not be detected.

[0051] 4. Determination of active ingredient content: Total polysaccharide content determination: The phenol-sulfuric acid method was used, with glucose as a reference standard. The absorbance was measured at a wavelength of 490 nm, and the total polysaccharide content was calculated.

[0052] Total flavonoid content determination: The absorbance was measured at a wavelength of 510 nm using ultraviolet spectrophotometry with rutin as a reference standard, and the total flavonoid content was calculated.

[0053] 5. Shelf life verification: An accelerated testing method was used, with samples placed at 40℃±2℃ and 75%±5% relative humidity for 6 months. Monthly samples were taken to test indicators such as disposable form, relative density, pH value, microbial limits, and active ingredient content. Six months of accelerated testing is equivalent to 24 months of storage at room temperature. Simultaneously, long-term sample retention and observation were conducted, continuously monitoring at room temperature for 24 months, and recording changes in various indicators.

[0054] IV. Examples Example 1: Ointment for Qi Deficiency Formula (by weight): Astragalus membranaceus 24 parts, Dioscorea opposita 20 parts, Poria cocos 12 parts, Codonopsis pilosula 11 parts, Jujube 16 parts, Longan 8 parts, Glycyrrhiza uralensis 3 parts, Honey 8 parts.

[0055] Preparation steps: 1) Raw material pretreatment: Weigh the astragalus, yam, poria, codonopsis, red dates, longan, and licorice separately, rinse them with running purified water to remove impurities, and place them in an oven at 45℃ for 3 hours to dry off the moisture introduced during the washing process. Put the dried raw materials into a pulverizer and pulverize them, then pass them through a 30-mesh sieve. Collect the sieve-passing material for later use.

[0056] 2) Low-temperature ultrasonic extraction: The pretreated raw material powder was placed into an ultrasonic extraction vessel, and purified water was added at a material-to-liquid ratio of 1:12. The ultrasonic temperature was set to 50℃, the ultrasonic power density to 20W / L, and the extraction time to 75min. During the extraction process, the mixture was stirred at a speed of 45r / min. After extraction, all the extract was collected, and the volume of the extract was measured to be approximately 8.5 times the weight of the raw material.

[0057] 3) Coarse filtration: The collected extract is coarsely filtered through a 200-mesh stainless steel screen to remove larger solid particles such as plant tissue residue.

[0058] 4) Vacuum-reduced low-temperature concentration: The coarse filtrate is fed into a vacuum concentration device, with the vacuum level set to -0.08 MPa and the concentration temperature set to 60°C. The relative density is measured to be 1.28 at 55°C, yielding a concentrated paste. The concentration process takes approximately 2.5 hours, and the weight of the concentrated paste is approximately 18% to 22% of the total weight of the raw materials.

[0059] 5) Mixing and homogenizing: Add 8 parts by weight of honey to the concentrated paste and stir at 60 r / min for 20 min until well mixed.

[0060] 6) Filling and sterilization: The prepared paste is aseptically filled into glass bottles, 200g per bottle, and pasteurized at 70℃ for 20 minutes. After cooling to room temperature, the bottles are sealed and packaged to obtain the finished product.

[0061] Product characteristics: Brownish-brown paste with a uniform and delicate texture, semi-fluid, with both jujube and honey aromas, a mild and sweet taste, and no bitter or burnt flavor.

[0062] Quality test results: relative density measured at 55℃ was 1.28, total polysaccharide content was 8.5%, total flavonoid content was 1.2%, total bacterial count was 500 CFU / g, coliform bacteria were negative, and mold and yeast count was 20 CFU / g.

[0063] Example 2: Yin Deficiency Essence Paste Ingredients (by weight): 16 parts Solomon's Seal, 16 parts Ophiopogon japonicus, 11 parts Lily bulb, 11 parts Tremella fuciformis, 12 parts Goji berries, 16 parts Dried snow pear, 3 parts Licorice root, 11 parts Honey.

[0064] Preparation steps: 1) Raw material pretreatment: Weigh the Solomon's Seal, Ophiopogon japonicus, lily bulb, white fungus, wolfberry, dried snow pear, and licorice separately, wash and remove impurities, dry in a forced-air dryer at 45℃ for 3 hours, pulverize and pass through a 30-mesh sieve, and set aside.

[0065] 2) Low-temperature ultrasonic extraction: The raw material powder was put into an ultrasonic extraction vessel, purified water was added at a material-to-liquid ratio of 1:11, the ultrasonic temperature was set to 48℃, the ultrasonic power density to 19W / L, the extraction time to 70min, and the stirring speed to 40r / min. All extract was collected.

[0066] 3) Coarse filtration: The collected extract is coarsely filtered through a 200-mesh stainless steel screen to remove larger solid particles such as plant tissue residue.

[0067] 4) Low-temperature concentration under reduced pressure: Set the vacuum degree to -0.08MPa and the concentration temperature to 58℃. Concentrate to 55℃ and measure the relative density to be 1.27 to obtain a concentrated paste.

[0068] 5) Mix and homogenize: Add 11 parts by weight of honey and stir at 55 rpm for 20 minutes.

[0069] 6) Filling and sterilization: After aseptic filling, pasteurize at 70℃ for 20 minutes, cool and seal the packaging.

[0070] Product characteristics: Light brown paste with a uniform texture, refreshing and sweet aftertaste, light and non-greasy honey fragrance, and no bitter taste.

[0071] Quality test results: The relative density measured at 55℃ was 1.27, the total polysaccharide content was 9.0%, the total flavonoid content was 1.0%, and the microbial limits met the standards.

[0072] Example 3: Moist Heat Ointment Formula (by weight): 8 parts chrysanthemum, 16 parts red adzuki bean, 24 parts coix seed, 7 parts honeysuckle, 6 parts lotus leaf, 3 parts licorice, and 8 parts honey.

[0073] Preparation steps: 1) Raw material pretreatment: Weigh chrysanthemum, red adzuki bean, coix seed, honeysuckle, lotus leaf and licorice separately, wash and remove impurities, dry in a forced air at 45℃ for 3 hours, pulverize and pass through a 30-mesh sieve, and set aside.

[0074] 2) Low-temperature ultrasonic extraction: Add purified water at a material-to-liquid ratio of 1:11, set the ultrasonic temperature to 52℃, the ultrasonic power density to 20W / L, the extraction time to 65min, and the stirring speed to 50r / min. Collect all the extract.

[0075] 3) Coarse filtration: The collected extract is coarsely filtered through a 200-mesh stainless steel screen to remove larger solid particles such as plant tissue residue.

[0076] 4) Reduced pressure and low temperature concentration: vacuum degree -0.08MPa, concentration temperature 62℃, the relative density measured at 55℃ is 1.29.

[0077] 5) Mix and homogenize: Add 8 parts by weight of honey and stir at 60 rpm for 20 minutes.

[0078] 6) Filling and sterilization: After aseptic filling, pasteurize at 71℃ for 19 minutes, cool and seal the packaging.

[0079] Product characteristics: Yellowish-brown paste with uniform texture, herbal fragrance, slightly bitter followed by sweetness, mild cooling effect, and no burnt smell.

[0080] Quality test results: relative density measured at 55℃ was 1.29, total polysaccharide content was 7.5%, total flavonoid content was 1.5%, and microbial limits met the standards.

[0081] Example 4: Mild Ointment Formula (by weight): 20 parts yam, 12 parts lotus seeds, 12 parts poria cocos, 12 parts wolfberry, 12 parts foxnut, 3 parts licorice, and 10 parts honey.

[0082] Preparation steps: Following the preparation method of Example 1, the material-to-liquid ratio was 1:12, the ultrasonic temperature was 50℃, the ultrasonic power density was 21W / L, the extraction time was 68min, the vacuum degree was -0.08MPa, the concentration temperature was 60℃, and the relative density was measured to be 1.31 at 55℃. 10 parts by weight of honey were added and mixed well, and pasteurized at 70℃ for 20min.

[0083] Product characteristics: Reddish-brown paste with a uniform texture, sweet and mild taste, and harmonious aroma.

[0084] Example 5: Yang Deficiency Essence Paste Formula (by weight): 8 parts dried ginger, 20 parts yam, 12 parts poria cocos, 12 parts wolfberry, 16 parts red dates, 11 parts alpinia oxyphylla, 10 parts raspberry, 7 parts desert cistanche deserticola, 11 parts codonopsis pilosula, 3 parts licorice, and 8 parts honey.

[0085] Preparation steps: Follow the preparation method in Example 1. Product characteristics: Dark brown paste with a blend of ginger and jujube aromas, a mild and slightly spicy taste, and no irritation.

[0086] Example 6: Phlegm-Dampness Ointment Formula (by weight): 24 parts coix seed, 14 parts poria cocos, 8 parts dried tangerine peel, 11 parts hawthorn, 6 parts lotus leaf, 3 parts licorice root, and 9 parts honey.

[0087] Preparation steps: Follow the preparation method in Example 1. Product characteristics: Yellowish-brown paste with a harmonious blend of tangerine peel aroma and hawthorn's slight acidity, offering a refreshing and non-greasy taste.

[0088] Example 7: Blood Stasis Ointment Formula (by weight): 16 parts hawthorn, 7 parts peach kernel, 11 parts angelica, 16 parts red dates, 10 parts rose petals, 3 parts licorice, and 9 parts honey.

[0089] Preparation steps: Follow the preparation method in Example 1. Product characteristics: Reddish-brown paste with a light rose fragrance, sweet and sour taste, and no bitterness.

[0090] Example 8: Qi Stagnation Ointment Ingredients (by weight): 11 parts rose petals, 9 parts Buddha's hand citron, 9 parts citron, 8 parts dried tangerine peel, 16 parts malt, 3 parts licorice, and 9 parts honey.

[0091] Preparation steps: Follow the preparation method in Example 1. Product characteristics: Light brown paste with a complex floral and fruity aroma and a refreshing taste.

[0092] Example 9: Special Ointment Formula (by weight): 20 parts yam, 12 parts lotus seeds, 11 parts lily bulbs, 12 parts poria cocos, 8 parts perilla leaves, 3 parts licorice root, and 9 parts honey.

[0093] Preparation steps: Follow the preparation method of Example 1. Product characteristics: Light brown paste with a perilla fragrance and a mild, sweet taste.

[0094] V. Experimental Examples Experiment Example 1: Optimization Experiment of Extraction Process Objective: To optimize the key process parameters of low-temperature ultrasonic extraction and determine the optimal extraction conditions.

[0095] Methods: Using the raw materials of the Qi deficiency constitution formula as a model, the total polysaccharide extraction rate and total flavonoid extraction rate were used as evaluation indicators. The L9(3)244547 ... 4An orthogonal experimental design was used to investigate the effects of four factors on the extraction efficiency: material-liquid ratio (A: 1:10, 1:12, 1:15), ultrasonic temperature (B: 45℃, 50℃, 55℃), ultrasonic power density (C: 15W / L, 20W / L, 25W / L), and extraction time (D: 60min, 75min, 90min).

[0096] result: ; Range analysis: The order of influence of each factor on the total polysaccharide extraction rate is B (temperature) > A (solid-liquid ratio) > D (time) > C (power); the order of influence on the total flavonoid extraction rate is A (solid-liquid ratio) > B (temperature) > D (time) > C (power).

[0097] Conclusion: The optimal extraction conditions are a material-to-liquid ratio of 1:12, an ultrasonic temperature of 50℃, an ultrasonic power density of 20W / L, and an extraction time of 75min. Under these conditions, the total polysaccharide extraction rate can reach 7.89%, and the total flavonoid extraction rate can reach 1.42%.

[0098] Experiment Example 2: Comparison of Tastes with Different Flavoring Schemes Objective: To verify the taste advantages of this invention by adjusting the amount of honey according to the different characteristics of body constitution (hot and cold).

[0099] Methods: Using the Yin-deficient constitution formula (for those with a cold constitution, requiring moisturizing) and the damp-heat constitution formula (for those with a warm constitution, requiring clearing and detoxifying) as models, three taste correction schemes were set up: Group A (no honey, pure raw material paste), Group B (uniform honey dosage, 9 parts each), and Group C (differentiated honey dosage, 11 parts for Yin-deficient constitution and 8 parts for damp-heat constitution). Thirty sensory evaluators (aged 25-55, half male and half female) were randomly selected from each group to score the taste on three dimensions: sweetness palatability, bitterness masking effect, and overall acceptability (maximum score 10 points).

[0100] result: ; Conclusion: The differentiated honey dosage regimen (Group C) scored significantly higher than the no-honey group (Group A) and the uniform dosage group (Group B) in all three dimensions (P<0.01). This indicates that adjusting the honey dosage according to the individual's constitution (hot or cold) can significantly improve the palatability of the ointment. Reducing the honey dosage for those with a warm constitution can avoid greasiness, while moderately increasing the honey dosage for those with a cold constitution can effectively neutralize bitterness.

[0101] Experiment Example 3: Comparison of active ingredient retention rates between the entire low-temperature process and the traditional high-temperature process Objective: To verify the advantages of the low-temperature process of the present invention in terms of preserving active ingredients compared with the traditional high-temperature cooking process.

[0102] Methods: Using the formula for Qi deficiency as a model, ointments were prepared using the process of this invention (≤65℃ throughout) and the traditional high-temperature decoction process (decoction at 100℃ under normal pressure for 4 hours, with a final temperature of 80-90℃). The contents of total polysaccharides and total flavonoids in the products obtained by the two processes were determined and compared with the theoretical total contents in the raw materials to calculate the retention rate.

[0103] result: ; Conclusion: The total polysaccharide retention rate of the low-temperature process of this invention (91.2%) is 27.4 percentage points higher than that of the traditional high-temperature process (61.8%); the total flavonoid retention rate (88.9%) is 33.3 percentage points higher than that of the traditional process (50.0%). This indicates that by strictly controlling the temperature throughout the extraction and concentration process to not exceed 65℃, this invention can significantly reduce the degradation of heat-sensitive active ingredients.

[0104] Experiment Example 4: Accelerated Stability Test Objective: To verify the stability of the ointment of the present invention under accelerated testing conditions and to predict its shelf life at room temperature.

[0105] Methods: Three batches of each of the ointments prepared in Examples 1-9 were taken and placed at a temperature of 40℃±2℃ and a relative humidity of 75%±5% for 6 months. Samples were taken at 0, 1, 2, 3, and 6 months to test the properties, relative density, total polysaccharide content, total flavonoid content, and microbial limits.

[0106] Results (represented by the Qi deficiency ointment in Example 1): ; The test results of Examples 2 to 9 are consistent with the trend of Example 1. No unqualified phenomena such as delamination, sand return, discoloration, or odor were found during the 6-month accelerated test, and the changes in all indicators were within the acceptable range.

[0107] Conclusion: All indicators in the accelerated test after 6 months met the quality standard requirements. Based on the correlation between the accelerated test and room temperature storage (6 months at 40℃ / 75%RH is equivalent to 24 months at room temperature), it is estimated that the shelf life of the ointment of this invention at room temperature is not less than 24 months, which is better than the requirement of not less than 18 months in the claims.

[0108] Experimental Example 5: Statistical analysis of the yield of ointments for nine different body constitutions Objective: To statistically analyze the average yield of nine different body constitution formulas under the process conditions of this invention.

[0109] Method: Ointments were prepared according to the formulations and processes of Examples 1 to 9, with each example repeated in 3 batches. The ointment yield (weight of finished ointment / total weight of raw materials × 100%) was calculated.

[0110] result: ; Conclusion: The average yield of the nine body constitution formulas under the process conditions of this invention was 16.8% to 21.9%, with small batch-to-batch differences (RSD < 3%), indicating that the process of this invention has good reproducibility and is suitable for industrial mass production.

[0111] VI. Comparative Experiment Comparative Experiment 1: Quality Comparison of the Ointment of the Present Invention with Commercially Available Similar Products Objective: To compare the quality of the ointment prepared in the embodiments of the present invention with commercially available similar body conditioning ointments.

[0112] Methods: Three commercially available ointment products claiming to have constitution-regulating functions (denoted as D1, D2, and D3, respectively) were selected as controls and compared with Example 1 of this invention (Qi-deficiency constitution ointment). The test indicators included: whether artificial additives were present, total polysaccharide content, total flavonoid content, and taste evaluation (scored by a 20-person panel, with a maximum score of 10).

[0113] result: ; Conclusion: The ointment of this invention contains no artificial additives, and its total polysaccharide and total flavonoid content are significantly higher than those of similar commercially available products (P<0.01). Its taste score is also significantly better than the control group. This indicates that the present invention has significant advantages in terms of natural properties, retention of active ingredients, and taste experience.

[0114] Comparative Experiment 2: Self-adhesive Granulation Control Experiment Objective: To verify the feasibility of the self-adhesive granulation technology without external excipients of the present invention (the experimental data also supports the second set of granule invention patents).

[0115] Methods: Using a formula for those with Qi deficiency as a model, three schemes were employed to prepare granules: Scheme A (the scheme of this invention, with 10% ultrafine powder and no exogenous excipients), Scheme B (adding 15% dextrin as a binder), and Scheme C (adding 15% starch as a binder). The forming rate, granule hardness, disintegration time (warm water, 40℃), and content of active ingredients were compared among the three schemes.

[0116] result: ; Conclusion: The molding rate of Scheme A in this invention reached 94.5%, which was not significantly different from Schemes B and C, which added exogenous excipients, but the disintegration time was shorter (45s) and the total polysaccharide content was higher (8.2% vs 6.5% and 6.0%). This shows that it is entirely feasible to form the product without adding exogenous excipients, relying on the self-adhesion of the ultrafine powder and extract, and the product has higher purity of active ingredients and better solubility.

[0117] Comparative Experiment 3: Quality Comparison of Different Sterilization Methods Objective: To compare the effects of pasteurization (68-73°C) and high-temperature sterilization (121°C) on the quality of ointments according to the present invention.

[0118] Method: Take the same batch of Qi deficiency paste and treat it by pasteurization (70℃, 20min) and high temperature and high pressure sterilization (121℃, 15min) according to the present invention. Compare the total polysaccharide content, total flavonoid content, color and taste of the sterilized products.

[0119] result: ; Conclusion: Pasteurization (68–73°C) of this invention achieved a retention rate of 97.8% and 93.8% for total polysaccharides and total flavonoids in the paste, respectively, significantly higher than that of high-temperature sterilization (121°C) (73.1% and 56.3%, respectively) (P<0.01), with minimal impact on the color and taste of the paste. This indicates that the pasteurization temperature range selected in this invention can maximize the protection of the active ingredients and sensory quality of the paste while ensuring sterilization effectiveness. 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 homoeopathic ointment based on nine differentiations of cold and heat of nine constitutions, characterized in that, It is composed of formulas corresponding to nine body constitutions, using honey as a natural flavoring agent, and contains no artificial flavors, colors, sucrose, or chemical preservatives; the specific formula of each component by weight is as follows: Balanced constitution: 19-21 parts yam, 11-13 parts lotus seed, 11-13 parts poria cocos, 11-13 parts wolfberry, 11-13 parts fox nut, 2-3 parts licorice, 9-11 parts honey; Qi deficiency constitution: Astragalus membranaceus 21-27 parts, Dioscorea opposita 19-21 parts, Poria cocos 11-13 parts, Codonopsis pilosula 10-12 parts, Jujube 15-17 parts, Longan 7-9 parts, Licorice 2-3 parts, Honey 7-9 parts; Yang deficiency constitution: 8-9 parts dried ginger, 19-21 parts yam, 11-13 parts poria cocos, 11-13 parts wolfberry, 15-17 parts red dates, 10-12 parts alpinia oxyphylla, 9-11 parts raspberry, 6-8 parts desert cistanche, 10-12 parts codonopsis pilosula, 2-3 parts licorice, 7-9 parts honey; Yin deficiency constitution: Polygonatum odoratum 15-17 parts, Ophiopogon japonicus 15-17 parts, Lilium brownii 10-12 parts, Tremella fuciformis 10-12 parts, Lycium barbarum 11-13 parts, dried pear 15-17 parts, Glycyrrhiza uralensis 2-3 parts, honey 10-12 parts; Phlegm-dampness constitution: 21-27 parts of coix seed, 12-15 parts of poria cocos, 8-9 parts of dried tangerine peel, 10-12 parts of hawthorn, 5-7 parts of lotus leaf, 2-3 parts of licorice root, and 8-10 parts of honey; Damp-heat constitution: Chrysanthemum 7-9 parts, red bean 15-17 parts, coix seed 21-27 parts, honeysuckle 6-8 parts, lotus leaf 5-7 parts, licorice 2-3 parts, honey 7-9 parts; Blood stasis constitution: 15-17 parts hawthorn, 7-8 parts peach kernel, 10-12 parts angelica, 15-17 parts red dates, 8-12 parts rose, 2-3 parts licorice, 8-10 parts honey; Qi stagnation constitution: 10-12 parts rose petals, 8-10 parts Buddha's hand citron, 8-10 parts citron, 8-9 parts dried tangerine peel, 15-17 parts malt, 2-3 parts licorice root, and 8-10 parts honey; Special constitution: 19-21 parts of yam, 11-13 parts of lotus seed, 10-12 parts of lily bulb, 11-13 parts of poria cocos, 8-9 parts of perilla leaf, 2-3 parts of licorice root, and 8-10 parts of honey.

2. The homoeopathic paste based on nine constitutional cold-heat differentiation flavors according to claim 1, characterized in that, All the Chinese medicinal materials used in each formula are listed as food and medicine homologous materials by the National Health Commission. 3.The nine-constitution cold-heat differentiation flavored functional paste of claim 1, characterized in that, The product should be stored in a sealed container at room temperature. It has a shelf life of ≥18 months and will not exhibit any delamination, sanding, discoloration, or odor during storage.

4. A method for preparing the homoeopathic ointment based on nine types of physical cold and heat differentiation according to any one of claims 1 to 3, characterized in that, Includes the following steps: Step 1: Raw material pretreatment: Clean and remove impurities from the raw materials in the formula, and crush them to 20-40 mesh for later use; Step 2: Low-temperature ultrasonic extraction: Add purified water to the raw material, control the material-to-liquid ratio at 1:10 to 1:15, ultrasonic temperature at 45 to 55°C, ultrasonic power density at 15 to 25 W / L, extraction time at 60 to 90 min, and collect all the extract. Step 3: The extract is coarsely filtered through a 200-mesh filter to remove solid residue; Step 4: Low-pressure concentration: Place the coarse filtrate in a low-pressure concentration device with a vacuum degree of -0.07 to -0.09 MPa and a concentration temperature of 55 to 65°C. When the concentration reaches 55°C, the relative density is measured to be 1.25 to 1.32, resulting in a thick concentrated paste. Step 5: Mix and homogenize: Add the corresponding weight of honey to the concentrated paste and stir thoroughly until well mixed; Step 6: Filling and sterilization: The prepared paste is aseptically filled and sterilized using pasteurization at a temperature of 68-73℃ for 18-22 minutes. After cooling, it is sealed and packaged to obtain the finished product.

5. The preparation method according to claim 4, characterized in that, The temperature during the entire extraction and concentration process shall not exceed 65℃.

6. The preparation method according to claim 4, characterized in that, The honey mentioned in step 5 is the honey weight portion corresponding to the body type formula in claim 1.

7. The preparation method according to claim 4, characterized in that, The ultrasonic extraction in step 2 uses an ultrasonic temperature of 50°C, an ultrasonic power density of 20W / L, and an extraction time of 75min.

8. The preparation method according to claim 4, characterized in that, The vacuum degree of the reduced pressure low temperature concentration in step 4 is -0.08 MPa, and the concentration temperature is 60°C.

9. The preparation method according to claim 4, characterized in that, The pasteurization process described in step 6 involves a sterilization temperature of 70°C and a sterilization time of 20 minutes.

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