A three-talented medicine composition with the effects of ventilating blood, five internal organs and meridians and its preparation process and application

Abstract

The application discloses a kind of three-talented Dan traditional Chinese medicine compositions with the efficacy of ventilating blood, five viscera and meridians and its preparation process and application, belong to the field of traditional Chinese medicine health care technology.The composition is made of arrow stem astragalus, white flower salvia, male and female human-shaped nine steamed prepared black root, chicken head rhizoma polygonati, high mountain woody yang-warming meridian-leading combination, medlar, ligustrum lucidum fruit, cuscuta, psoralea, cortex moutan, angelica, hawthorn, herba epimedii, semen ziziphi spinosae, chrysanthemum, and is made by matching with specific weight percentage.The application also provides three application dosage forms of the composition: high-end three-talented Dan concentrated honeyed pill, medium-end diet therapy meal-adding composition and low-end external use meridian dredging lixivium.The application solves the problems of poor quality of raw materials, shallow drug effect, single dosage form and high cost of existing three-talented Dan, has the advantages of deep drug effect, accurate meridian leading, safety and convenience, full-scene coverage and the like, is suitable for various sub-health and chronic disease health care scenes such as blood deficiency, five viscera disharmony and meridian stagnation, and has significant market application value.

Description

Technical Field

[0001] This invention belongs to the fields of traditional Chinese medicine health care, traditional Chinese medicine preparations, and functional food technology. Specifically, it relates to a Sancai Dan traditional Chinese medicine composition that has the effects of promoting qi and blood circulation, clearing the five internal organs, and clearing the meridians. It also discloses the preparation process of its high-end internal concentrated water-honey pills, mid-range food and medicine homology food therapy composition, and low-end external meridian clearing fluid extract, as well as its application in sub-health and chronic disease rehabilitation products related to qi and blood deficiency, disharmony of the five internal organs, and meridian stagnation. Background Technology

[0002] Currently, in the field of traditional Chinese medicine health care, most products targeting the needs of "unblocking qi and blood, unblocking the five internal organs, and unblocking the meridians" are mainly in the form of oral liquids, which have significant technical defects and are difficult to meet the actual needs of clinical and daily conditioning.

[0003] From the perspective of raw materials, most commercially available three-way tonifying preparations use common, generic medicinal materials, such as common Astragalus membranaceus, common Salvia miltiorrhiza, common Polygonatum sibiricum, and common processed Polygonum multiflorum. These materials have low levels of active ingredients (e.g., the content of common Astragaloside A is only 0.04%-0.08%, far lower than the 0.12%-0.18% of Astragalus membranaceus), resulting in superficial medicinal properties and difficulty in penetrating deep into the meridians of the lower abdomen. Consequently, their effectiveness in improving chronic blockages and peripheral circulation disorders is limited. Furthermore, there are no unified standards for the grade of medicinal materials, leading to significant quality fluctuations between different batches and making it impossible to guarantee stable therapeutic effects.

[0004] From the perspective of formulation, traditional three-way formulas have a high proportion of tonifying herbs (usually accounting for more than 50% of the total weight) and lack targeted meridian-guiding and harmonizing ingredients. Long-term use can easily lead to stagnation in the middle jiao, dysfunction of the spleen and stomach, and the generation of phlegm and dampness, which in turn hinders the circulation of qi and blood. For example, in existing compound preparations containing processed Polygonum multiflorum, if there are no spleen-invigorating and grease-dispersing ingredients, about 35% of users will experience adverse reactions such as abdominal distension and loss of appetite after continuous use for more than 3 months. In addition, existing formulas lack a dedicated descending meridian-guiding system, and the medicinal power mostly stays in the middle and upper jiao. The conditioning of the head, feet, extremities, and hemisphere of the body is slow. Clinical data shows that for patients with hemisphere meridian blockage due to stroke sequelae, the average effective period of existing oral liquids is 45 days, which is much longer than the 21 days of the product of this invention.

[0005] From a dosage form and manufacturing process perspective, oral liquid preparations rely on aseptic filling and preservation stabilization processes, resulting in complex production processes, large equipment investments (approximately 8 million yuan per production line), and high production costs (around 25 yuan per 100ml of oral liquid). This leads to expensive retail prices (market prices are mostly between 150-300 yuan per box), limiting them to a niche high-end consumer market and preventing widespread accessibility. Furthermore, oral liquids require the addition of preservatives (such as sodium benzoate and potassium sorbate) to ensure shelf life, which may increase the metabolic burden on the liver and kidneys with long-term use, making them particularly unsuitable for sub-healthy individuals with impaired liver or kidney function. In addition, oral liquid formulations are inconvenient to carry and require multiple daily doses (usually 2-3 times a day, 10-20ml each time), leading to poor adherence and difficulty in meeting long-term health and wellness needs.

[0006] From a product system perspective, existing technologies are mostly single dosage forms, failing to form a product matrix covering different consumer levels and application scenarios. For example, a well-known oral liquid for clearing heat and dampness targets only the high-end market, lacking dietary therapy products suitable for daily conditioning of the general public or external preparations for local meridian blockages, resulting in a market coverage of less than 15%, leaving a large amount of potential demand unmet. Furthermore, existing products have not been specifically modified to address the core pathogenesis of "mixed deficiency and stagnation, disorder of the five internal organs, and deep meridian blockage," lacking authentic and exclusive medicinal material standards, balanced and warming combinations for guiding the yang energy through the meridians, and a three-dimensional product system combining internal administration, dietary therapy, and external application, indicating significant technological gaps.

[0007] Existing traditional Chinese medicine preparations for the "three-way" method only focus on replenishing qi and promoting blood circulation. They lack a three-tiered formulation system based on the three elements of heaven, earth, and man, as well as exclusive descending and guiding components. They can only superficially clear the qi and blood in the upper and middle jiao, and cannot simultaneously solve the two core problems of tonifying herbs stagnating the spleen and stomach and the inability of medicinal effects to reach the lower jiao of the limbs due to long-term stagnation. Furthermore, the industry lacks a complete product solution integrating oral medications, daily dietary therapy foods, and topical physiotherapy ointments, and there are significant gaps in related technologies.

[0008] In summary, existing three-way health and wellness preparations have significant deficiencies in terms of raw material quality, formulation compatibility, dosage form and process, and product system. There is a need for a health and wellness composition and its preparation technology that is based on authentic and exclusive medicinal materials, has scientific compatibility, appropriate dosage form, and covers all scenarios, in order to solve the industry pain points of traditional preparations such as being too rich and greasy and causing stomach upset, having superficial medicinal effects, having a single dosage form, high cost, and limited target audience. Summary of the Invention

[0009] In view of this, the present invention provides a Sancai Dan traditional Chinese medicine composition with the functions of promoting blood circulation, clearing the five internal organs and clearing the meridians, as well as its preparation process and application, so as to solve or alleviate one of the technical problems existing in the prior art, and at least provide a beneficial option.

[0010] This invention uses Polygonum multiflorum (He Shou Wu) processed through a nine-stage steaming and drying process, employing traditional methods to significantly degrade potentially liver-irritating anthraquinone toxic components such as emodin and chrysophanol. Simultaneously, the stilbene glycoside content of the medicinal material is limited to ≥2.0%, using effective component quality control indicators to conversely constrain toxic substance residues. In a 3-month human clinical trial, all subjects showed no abnormal fluctuations in liver function indicators, demonstrating controllable safety for long-term internal use. The dietary therapy formula completely excludes processed Polygonum multiflorum, and all raw materials are included in the National Food and Medicine Homologous List, thoroughly eliminating compliance risks associated with the use of Polygonum multiflorum in food products.

[0011] This formula is named "Sancai Dan" (Three Talents Pill), based on the traditional Chinese medicine system of differentiation of syndromes involving Heaven, Earth, and Man. The ingredients in the formula are layered and correspond to the three dimensions, each performing its specific function to work together to achieve the core effects of promoting the flow of Qi and blood, clearing the five internal organs, and unblocking the meridians. The Heavenly Division (clearing the orifices and calming the mind, corresponding to the upper burner, head, face, heart, and spirit): Epimedium, Ziziphus jujuba seed, and Chrysanthemum belong to the Heavenly Division of the Three Powers. Ziziphus jujuba seed nourishes the heart and calms the mind, improving insomnia caused by deficiency of Qi and blood; Chrysanthemum clears the head and eyes and unblocks stagnation in the meridians of the upper burner; Epimedium warms Yang and promotes the upward movement of clear Qi, dredging the Qi and blood in the head and face, targeting symptoms such as dizziness, restlessness, and stagnation of Qi in the upper burner.

[0012] The Earth element (nourishing Yin and strengthening the foundation, corresponding to the lower burner, liver, kidneys, and other internal organs): A combination of nine-times-steamed Polygonum multiflorum (male and female human-shaped), Polygonatum sibiricum (chicken-head polygonatum), Lycium barbarum, Ligustrum lucidum, Cuscuta chinensis, and Lycium chinense root bark, belonging to the Earth element (representing the three elements of Heaven, Earth, and Man). The combination of these herbs nourishes and replenishes the Yin essence of the liver and kidneys, gently tonifies the five internal organs, addresses the root causes of organ deficiency and insufficient Qi and blood in the lower burner, and strengthens the body's prenatal and postnatal foundation.

[0013] The Human Section (promoting blood circulation and unblocking meridians, corresponding to the body's meridians and blood): A combination of Astragalus membranaceus (arrow shaft), Salvia miltiorrhiza (white flower), Angelica sinensis, hawthorn, and alpine woody herbs to warm the Yang and guide the meridians, belonging to the Human element (representing the Three Powers). Astragalus membranaceus greatly replenishes the body's vital energy, while Salvia miltiorrhiza, Angelica sinensis, and hawthorn nourish blood, dispel blood stasis, reduce fat, and unblock meridians. Combined with an original meridian-guiding component, it connects the upper and lower parts of the body, linking the medicinal power of the Heaven and Earth sections, allowing Qi and blood to circulate throughout the body, and ensuring unobstructed flow through the meridians.

[0014] The synergistic combination of Heaven, Earth, and Man clears the mind and spirit above, nourishes the liver, kidneys, and five internal organs below, and unblocks the meridians throughout the body in the middle, precisely targeting the core pathogenesis of deficiency and stagnation, disharmony of the five internal organs, and deep obstruction of the meridians in middle-aged and elderly people.

[0015] The technical solution of this invention is implemented as follows: A Sancai Dan herbal composition with the effects of promoting blood circulation, clearing the five internal organs, and unblocking the meridians is composed of the following medicinal materials in parts by weight, totaling 100 parts by weight, with an error fluctuation of ±2%: The principal herb group consists of 42 parts by weight, including 11 parts by weight of Astragalus membranaceus, 11 parts by weight of Salvia miltiorrhiza, 10 parts by weight of Polygonum multiflorum (processed nine times with male and female human-shaped herbs), and 10 parts by weight of Polygonatum sibiricum. The assistant herb group consists of 6 parts by weight, which is a combination of alpine woody herbs that warm the yang and guide the meridians; the auxiliary herb group consists of 24 parts by weight, which includes 7 parts by weight of wolfberry, 6 parts by weight of privet fruit, 6 parts by weight of dodder seed, and 5 parts by weight of lycium bark. The adjuvant herbs for promoting blood circulation and reducing lipids consist of 14 parts by weight, including 8 parts by weight of Angelica sinensis and 6 parts by weight of hawthorn; the guiding herbs for calming the mind and clearing the orifices consist of 14 parts by weight, including 5 parts by weight of Epimedium, 5 parts by weight of Ziziphus jujuba var. spinosa, and 4 parts by weight of chrysanthemum. Among them, the arrow-shaped Astragalus is the dried root of Astragalus mongholicus of the Fabaceae family, with a growth period of more than 3 years, a straight main root shaped like an arrow shaft, a diameter ≥1.5cm, and a quality control standard of astragaloside A content ≥0.12%; The dried roots and rhizomes of the white-flowered Salvia miltiorrhiza cultivar (Lamiaceae family) are described, with robust roots and a tanshinone IIA content ≥0.35% according to quality control standards. The aforementioned male and female human-shaped processed Polygonum multiflorum is the dried tuberous root of Polygonum multiflorum from the Polygonaceae family. Naturally, the two connected tubers resemble a human figure. It undergoes a standardized nine-steaming and nine-drying process to reduce toxicity, with a stilbene glycoside content of ≥2.0% as per quality control standards. The aforementioned *Polygonatum sibiricum* is the dried rhizome of cultivated *Polygonatum sibiricum* (Liliaceae family), with a quality control standard of ≥12% polysaccharide content. The alpine woody warming and guiding combination is a mixture of dried branches and leaves of woody shrubs of the Rhododendron and Rosaceae families in high-altitude cold mountainous areas above 2000m. The core active substance is volatile oil with a volatile oil content of ≥1.8%. After being crushed, it is passed through a 40-80 mesh sieve before use.

[0016] Preferably, the astragaloside A content of the Astragalus membranaceus is ≥0.12%, the tanshinone IIA content of the Salvia miltiorrhiza is ≥0.35%, the stilbene glycoside content of the Polygonum multiflorum prepared by steaming male and female human-shaped herbs is ≥2.0%, the Polygonatum sibiricum polysaccharide content of the Polygonatum sibiricum is ≥12%, and the volatile oil content of the alpine woody warming and guiding combination is ≥1.8%.

[0017] As a preferred option, the alpine woody warming and guiding combination is used after being crushed and passed through a 40-80 mesh sieve. It is neutral in nature and has the effects of relieving stagnation, invigorating the spleen and breaking up greasiness, and promoting downward flow of qi and blood. It can break up the stagnation in the middle jiao of the nourishing medicinal materials and guide the medicinal power of the whole formula to sink to the five internal organs, the lower jiao and the extremities.

[0018] Preferably, the following steps are included: (1) Low-temperature water extraction: Mix the traditional Chinese medicine composition according to any one of claims 1-3 and add 6-8 times the amount of purified water, soak at 60-70℃ for 1.5-2.5h, and then reflux extract at 80-90℃ twice, each time for 1-1.5h, combine the extracts and filter; (2) Alcohol precipitation purification: Cool the filtered extract to 20-30℃, add 95% ethanol until the alcohol content reaches 55-65%, let it stand at 2-6℃ for 20-28h, take the supernatant and recover the ethanol until there is no alcohol odor, and control the residual ethanol content to ≤0.5%; (3) Vacuum concentration: The supernatant after ethanol recovery is vacuum concentrated at 55-65℃ and -0.07 to -0.09MPa to obtain an extract with a relative density of 1.35-1.40 (measured at 60℃); (4) Making pills: Mix the extract and refined honey at a mass ratio of 1:1.1-1.3, knead them into pills at 40-50℃, and then roll them into strips and cut them into pills to make raw water-honey pills weighing 8-10g each. (5) Drying and packaging: Dry the raw water-honey pills at 45-50℃ until the moisture content is ≤9%, and seal them individually with gold aluminum foil.

[0019] Preferably, in step (1), the amount of purified water added is 8 times the total mass of the medicinal materials, the soaking temperature is 65°C, the soaking time is 2 hours, the reflux extraction temperature is 85°C, and the extraction time is 1.5 hours each time. The alcohol content in step (2) is 60%, the standing temperature is 4°C, and the standing time is 24h; The vacuum concentration conditions described in step (3) are 60℃ and -0.08MPa, and the relative density of the extract is 1.38 (measured at 60℃). The mass ratio of the extract to refined honey in step (4) is 1:1.2, and the weight of the pills is 9g. The drying temperature in step (5) is 48°C.

[0020] As a preferred embodiment, the modified traditional Chinese medicine composition according to claim 1 is used, wherein the modification method is as follows: Remove the male and female human-shaped nine-steamed Polygonum multiflorum, and adjust the following ingredients to 10 parts by weight: Astragalus membranaceus, Salvia miltiorrhiza, Polygonatum sibiricum, Lycium barbarum ... Preparation methods include: mixing and pulverizing the adjusted medicinal materials, passing them through an 80-100 mesh sieve to make a mixed powder, or packaging the mixed powder into 10-15g bags to make a substitute tea, or mixing the mixed powder with edible salt and monosodium glutamate in a mass ratio of 5:3:2 to make a condiment.

[0021] Preferably, the fineness of the mixed powder is 80 mesh, and the mixing uniformity RSD is ≤3.0%; The brewing conditions for the substitute tea are as follows: each bag should be brewed with 200-300mL of boiling water, covered and steeped for 8-12 minutes, with an effective ingredient dissolution rate of ≥75%; The amount of the accompanying seasoning added is 0.5-2.0% of the daily dietary intake.

[0022] As a preferred embodiment, the modified traditional Chinese medicine composition according to claim 1 is used, wherein the modification method is as follows: The following ingredients were adjusted: Astragalus membranaceus (arrow shaft) 9 parts by weight, Salvia miltiorrhiza (white flower) 9 parts by weight, Polygonatum sibiricum (chicken head) 11 parts by weight, Alpine woody warming and guiding combination 7 parts by weight, Lycium barbarum 6 parts by weight, Ligustrum lucidum 5 parts by weight, Cuscuta chinensis 5 parts by weight, Angelica sinensis 7 parts by weight, Crataegus pinnatifida 5 parts by weight, Epimedium brevicornu 6 parts by weight, Ziziphus jujuba var. spinosa 3 parts by weight, and Chrysanthemum morifolium 2 parts by weight. The preparation process includes: (1) Ethanol reflux extraction: Add 5-7 times the amount of 60-80% ethanol to the adjusted Chinese herbal composition and reflux extract at 75-85℃ 3 times, each time for 0.8-1.2h. Combine the extracts and filter. (2) Vacuum concentration: The filtered extract was vacuum concentrated at 60-70℃ and -0.08 to -0.10 MPa to a fluid extract with a relative density of 1.20-1.25 (measured at 25℃), and the residual ethanol content was controlled to be ≤0.5%; (3) Dispensing: Dispense the fluid extract into brown glass bottles at a rate of 50-100mL per bottle, seal and store away from light.

[0023] Preferably, the concentration of ethanol in step (1) is 70%, the amount added is 6 times the total mass of the medicinal materials, the reflux extraction temperature is 80℃, and the extraction time is 1h each time; The vacuum concentration conditions described in step (2) are 65℃ and -0.09MPa, and the relative density of the fluid extract is 1.23 (measured at 25℃). The dispensing specification mentioned in step (3) is 50mL / bottle, and the dispensing process is carried out in a Class 100 clean area.

[0024] Preferably, the product includes: Internal pills for treating qi and blood deficiency, disharmony of the five internal organs, stagnation of meridians, post-stroke sequelae rehabilitation, and insomnia; dietary supplements for daily conditioning of the general public; and meridian-clearing fluid extracts for external application to areas of blocked meridians on the body surface. The daily dosage of the oral pills is equivalent to 10-15g of the original medicinal materials, the daily intake of the dietary supplement is equivalent to 5-10g of the original medicinal materials, and the daily application dosage of the external fluid extract is 2-5g / cm² of skin area. The products include concentrated oral medicinal pills, functional substitute teas that are both food and medicine, dietary supplements, external skin therapy fluid extracts, and health care products for sub-health conditions. The applicable treatment scenarios include deficiency of qi and blood, disharmony of the five internal organs, stagnation of meridians, rehabilitation of stroke sequelae, and daily maintenance for people with irritability and insomnia.

[0025] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions: First, this formula utilizes four exclusive, authentic principal herbs: Astragalus membranaceus (arrow shaft), Salvia miltiorrhiza (white flower), Polygonum multiflorum (steamed nine times), and Polygonatum sibiricum (chicken head). The content of their effective components is significantly higher than that of ordinary, generic medicinal materials (e.g., the content of Astragaloside A in Astragalus membranaceus (arrow shaft) is 50%-125% higher than that in ordinary Astragalus membranaceus, and the content of Tanshinone IIA in Salvia miltiorrhiza (white flower) is 40%-75% higher than that in ordinary Salvia miltiorrhiza). Animal efficacy tests have verified that, at the same dosage, the penetration depth of this formula is more than 60% greater than that of formulas using ordinary, generic medicinal materials, allowing it to penetrate deep into the meridians of the lower abdomen, significantly improving chronic stagnation and peripheral circulatory disorders. Experimental data show that the water extract of the principal herbs in this invention has a 38.5% higher vasodilation rate in isolated rat thoracic aortic rings than the ordinary principal herb group (P<0.01).

[0026] Secondly, a new alpine woody herbal warming and guiding herb combination was added as a dedicated guiding herb. Its properties are mild and warm, pungent and aromatic, possessing three functions: promoting yang and relieving stagnation, invigorating the spleen and breaking up greasiness, and guiding the herbs downwards. On the one hand, it can break up the stagnation in the middle jiao caused by tonifying herbs such as Polygonatum, Polygonum multiflorum, and Lycium barbarum, avoiding spleen and stomach discomfort caused by long-term use; on the other hand, it can guide the entire formula's medicinal power downwards to the five internal organs, lower jiao, and extremities, achieving permeability throughout the body from head to toe. Animal experiments showed that after adding the alpine woody warming and guiding herb combination, the drug concentration in the lower limb extremities of mice was 2.3 times higher than the unadded group (P<0.05), and the concentration in the lower jiao organs such as the kidneys and liver was 1.8 times higher (P<0.05).

[0027] Third, the core high-end product uses a low-temperature, high-concentration extract formulation – the honey-water pill – which completely breaks away from the existing extraction, preservation, and filling processes of oral liquids. It requires no added preservatives, avoiding the metabolic burden on the liver and kidneys from long-term use. The pill dosage form has good stability, and the individual gold foil packaging effectively protects against light and locks in efficacy, extending the shelf life to 36 months (oral liquids typically have a shelf life of 24 months). It is extremely easy to take, one pill daily, improving compliance by 75% compared to oral liquids. Production costs are 40% lower than oral liquids (the comprehensive cost per pill is approximately 15 yuan, while the cost of an equivalent oral liquid is approximately 25 yuan), allowing for a 30% reduction in retail pricing, making it more acceptable to the general public.

[0028] Fourth, a three-dimensional product system will be constructed, consisting of "high-end pills + mid-range dietary therapy + low-end external applications." The high-end Sancai pills will serve as a benchmark product to lock in profits; the mid-range dietary therapy and meal supplements will target a more affordable market, covering the general public's daily health needs; and the low-end external fluid extracts will fill in specific treatment scenarios, achieving mass market coverage of a niche high-end product. Market research shows that this system can increase the target market coverage from 15% of existing products to over 85%, possessing a "David and Goliath" market substitution advantage.

[0029] Fifth, the auxiliary herbs in the Yin-nourishing and harmonizing group (Lycium barbarum, Ligustrum lucidum, Cuscuta chinensis, and Lycium chinense root bark) nourish the Yin of the liver and kidneys, clear away floating deficiency fire, and balance the slightly pungent and dispersing nature of the guiding herbs, avoiding excessive heat and Yin deficiency with prolonged use; the adjuvant herbs in the blood-activating and lipid-reducing group (Angelica sinensis and Crataegus pinnatifida) nourish and activate blood, reduce lipids and remove blood stasis, specifically targeting blood stasis; the guiding herbs in the mind-calming and orifice-clearing group (Epimedium brevicornu, Ziziphus jujuba var. spinosa, and Chrysanthemum morifolium) warm and tonify kidney Yang, nourish the heart and calm the mind, and clear the head and eyes. The combined effects of these herbs achieve warming and unblocking without harming Yin, and nourishing without aggravating pathogens, making them suitable for middle-aged and elderly individuals with long-term deficiency and blood stasis constitution. Clinical observations show that after three months of continuous use of the pills of this invention, the improvement rate of Qi and blood deficiency symptoms reached 92.3%, the improvement rate of five-organ disharmony symptoms reached 88.7%, and the improvement rate of meridian stagnation symptoms reached 90.5%, with no serious adverse reactions occurring.

[0030] Innovation in Authentic Graded Medicinal Herbs: By limiting the medicinal herbs to specific specifications and setting a lower limit for effective components, the efficacy is far superior to that of ordinary generic medicinal herbs, and the medicinal power penetrates deeper into the body. Original alpine woody herbal compatibility system: solves the inherent defects of traditional tonifying formulas that are too rich and cloying and hinder the stomach, and whose medicinal effects do not reach the lower extremities; Differentiated and exclusive extraction process: No preservatives are needed for oral pills, resulting in lower overall production costs and significantly improved user compliance; A three-dimensional gradient product matrix: covering high-end chronic disease care, daily dietary therapy for the general public, and local meridian external application scenarios, covering all levels of consumer groups, with outstanding industrial transformation value.

[0031] The formula contains multiple yin-nourishing herbs such as privet fruit, lycium bark, and wolfberry to counteract the warming and drying properties of epimedium. Long-term continuous use does not cause adverse reactions such as dry mouth, hot flashes, irritability, or fever. It is suitable for middle-aged and elderly people with a complex constitution of yin deficiency and yang deficiency. Detailed Implementation

[0032] Example 1: Preparation of Sancai Dan (Highly Concentrated Water-Honey Pill)

[0033] 1. Raw material preparation

[0034] Weigh the medicinal materials according to the following weight proportions (total 100 parts by weight, error ±1.5%):

[0035] 2. Preparation process

[0036] 2.1 Low-temperature water extraction

[0037] The above-mentioned medicinal materials were mixed and then added to 8 times the volume of purified water (volume / mass, L / kg). The mixture was soaked at 65℃ for 2 hours, then refluxed twice at 85℃ for 1.5 hours each time. The extracts were filtered through a 200-mesh sieve and combined to obtain an aqueous extract with a volume 6.5 times the total mass of the medicinal materials. The results of the analysis of the main components in the aqueous extract are shown in the table below:

[0038] 2.2 Alcohol precipitation purification

[0039] The aqueous extract was cooled to 25°C, and 95% ethanol was slowly added while stirring until the alcohol content reached 60% (volume fraction). The mixture was then allowed to stand at 4°C for 24 hours. The supernatant was collected by siphon, and the lower precipitate was discarded. Ethanol was recovered from the supernatant using a rotary evaporator at 60°C and -0.08 MPa until no alcohol odor remained (ethanol residue ≤0.5%), yielding a purified solution with a volume of 40% of the aqueous extract. The retention rates of the main components in the purified solution are shown in the table below.

[0040] 2.3 Vacuum Concentration

[0041] The purified solution was transferred to a vacuum concentrator and concentrated at 60℃ and -0.08 MPa to a relative density of 1.38 (measured at 60℃), yielding an extract with a weight of 28% of the total medicinal material mass. The physicochemical properties of the extract are shown in the table below:

[0042] 2.4 Pelletizing

[0043] The extract and refined honey (refined at 115℃, relative density 1.37) were mixed at a mass ratio of 1:1.2 and kneaded at 45℃ to form uniform pellets with moderate hardness and smooth surfaces. The pellets were then placed in a pelleting machine, rolled into strips, and cut into pellets, producing raw water-honey pills weighing 9g each. The pills were round, uniform in size, and the variation was ≤±5%. The parameters for the pelleting process were controlled as shown in the table below.

[0044] 2.5 Dry Packaging

[0045] The raw water-honey pills were placed in a hot air circulating oven and dried at a low temperature of 48℃ until the moisture content was ≤9% (drying time approximately 24 hours). They were then removed and cooled to room temperature. Each pill was individually sealed in gold aluminum foil (0.02mm thick). The packaged finished products had a clean appearance, were undamaged, and exhibited good sealing. The quality inspection results of the finished products are shown in the table below:

[0046] 3. Product Performance

[0047] The Sancai Dan water-honey pills prepared in this embodiment have concentrated medicinal power and strong targeting, and have a significant effect on improving symptoms such as deficiency of qi and blood, disharmony of the five internal organs, and stagnation of meridians.

[0048] Clinical trials showed that in 60 patients (aged 45-70) with qi and blood deficiency and meridian stagnation, after taking one pill daily for 30 consecutive days, the total effective rate reached 93.3%, of which the significant effective rate reached 63.3%, and no adverse reactions such as dry mouth, constipation, or abdominal distension occurred.

[0049] Example 2: Preparation of a dietary therapy meal supplement composition (tea substitute)

[0050] 1. Raw material preparation

[0051] Weigh the medicinal materials according to the following weight proportions (total 100 parts by weight, error ±1.8%). All medicinal materials meet the requirements of the list of substances that are both food and medicine:

[0052] 2. Preparation process

[0053] 2.1 Crushing and sieving

[0054] Wash and dry the above-mentioned medicinal materials separately (moisture content ≤10%), mix them together, and then pulverize them in a universal grinder. Pass the pulverized mixture through an 80-mesh sieve to obtain a uniform powder with consistent fineness and color. The grinding process parameters are controlled as shown in the table below.

[0055] 2.2 Mix thoroughly

[0056] The sieved powder mixture was placed in a three-dimensional motion mixer and mixed for 30 minutes, with a mixing uniformity RSD ≤ 3.0%. Samples were taken during the mixing process to test the content of each component; the results are shown in the table below.

[0057] 2.3 Repackaging

[0058] The well-mixed powder was dispensed into 10g portions into food-grade filter paper bags and sealed using an automatic packaging machine, ensuring a tight seal and preventing powder leakage. The dispensing process parameters are controlled as shown in the table below:

[0059] 3. Product Performance

[0060] The dietary therapy tea prepared in this embodiment retains the core formulation logic, has mild medicinal properties, and is suitable for daily conditioning by the general public. Sensory evaluation shows that the tea soup is brownish-yellow, clear and bright, has the unique aroma of medicinal herbs, a sweet, mild and slightly spicy taste, and no off-flavors.

[0061] Brewing tests show that when each sachet is brewed with 200mL of boiling water and steeped for 10 minutes with the lid on, the dissolution rate of the active ingredients reaches over 75%.

[0062] In a study of 120 individuals in a sub-healthy state (aged 30-65, exhibiting mild blood and qi deficiency, fatigue, and weakness), one sachet was consumed daily for 60 consecutive days. The fatigue improvement rate reached 86.7%, the sleep quality improvement rate reached 78.3%, and no adverse reactions were observed.

[0063] The product's physicochemical and microbiological indicators all meet the requirements of GB / T 29602-2013 "Solid Beverages" and GB 7101-2015 "National Food Safety Standard for Beverages". Specific test results are shown in the table below:

[0064] Example 3: Preparation of Meridian Unblocking Fluid Extract

[0065] 1. Raw material preparation

[0066] Weigh the medicinal materials according to the following weight percentages (total 100 parts by weight, error ±2.0%). All medicinal materials must meet the Class II standard of the current edition of the Chinese Pharmacopoeia:

[0067] 2. Preparation process

[0068] 2.1 Ethanol reflux extraction

[0069] The above-mentioned medicinal materials were mixed and then 6 times the volume of 70% ethanol (volume / mass, L / kg) was added. The mixture was refluxed three times at 80℃, 1 hour each time. The extracts were filtered through a 200-mesh sieve and combined to obtain an ethanol extract with a volume of 5.5 times the total mass of the medicinal materials. The results of the analysis of the main components in the extract are shown in the table below:

[0070] 2.2 Vacuum Concentration

[0071] The ethanol extract was transferred to a vacuum concentration tank and concentrated at 65℃ and -0.09 MPa to a relative density of 1.23 (measured at 25℃), yielding a fluid extract with a weight of 35% of the total medicinal material mass. The ethanol recovery rate during the concentration process was ≥85%. The physicochemical properties of the fluid extract are shown in the table below.

[0072] 2.3 Repackaging

[0073] After cooling the fluid extract to room temperature, it was dispensed into 50ml vials into brown glass bottles and sealed using a crimping machine. Butyl rubber gaskets were used on the caps to ensure a tight seal. The dispensing process was carried out in a Class 100 cleanroom to avoid microbial contamination. The dispensing process parameters are controlled as shown in the table below:

[0074] 3. Product Performance

[0075] The meridian-clearing fluid extract prepared in this embodiment is designed specifically for external use, with high drug concentration and good transdermal absorption.

[0076] Skin irritation tests showed that after continuous application to the back skin of 20 New Zealand rabbits for 14 days, no irritation reactions such as erythema or edema were observed, and the skin allergy rate was 0%. Transdermal absorption tests indicated that the drug components could penetrate to a subcutaneous depth of 3-5 mm within 1 hour after application, and the retention time in local tissues could reach more than 8 hours.

[0077] In 80 patients with knee joint meridian blockage (manifesting as pain and limited mobility), the pain score (VAS) decreased from 6.8±1.2 points before treatment to 2.3±0.9 points after 14 days of continuous use with the application twice daily and massage (P<0.01), and the improvement rate of joint mobility reached 87.5%.

[0078] The product's microbial limits and heavy metal content meet the requirements of General Chapter 0106, Volume IV, of the 2020 edition of the Chinese Pharmacopoeia. Specific test results are shown in the table below:

[0079] This product is extracted using 70% ethanol under reflux, which enhances the transdermal absorption efficiency of the herbal ingredients. A 14-day skin irritation test on New Zealand rabbits showed no erythema, edema, itching, or other irritation or allergic reactions on the tested skin. Contraindications: Do not apply to broken, ulcerated skin or during the acute phase of eczema; use with caution in pregnant women and those with severely sensitive skin; this product is for topical application only to unblock meridians and is strictly prohibited from oral ingestion.

[0080] The above description is merely a specific embodiment of the present invention. The scope of protection of the present invention is not limited to the medicinal material ratios and process parameters recorded in the embodiments of this specification. Similar Chinese medicine products obtained by those skilled in the art based on the core technical solution of the present invention through simple equivalent medicinal material substitution and fine-tuning of conventional process parameters are all within the scope of protection of the claims of the present invention.

Claims

1. A Sancai Dan traditional Chinese medicine composition with the effects of activating blood circulation and qi flow, dredging the five zang organs, and unblocking the meridians, characterized in that, Composed of the following medicinal materials in parts by weight, totaling 100 parts by weight, with an error margin of ±2%: The principal herb group consists of 42 parts by weight, including 11 parts by weight of Astragalus membranaceus, 11 parts by weight of Salvia miltiorrhiza, 10 parts by weight of Polygonum multiflorum (processed nine times with male and female human-shaped herbs), and 10 parts by weight of Polygonatum sibiricum. The assistant herb group consists of 6 parts by weight, which is a combination of alpine woody herbs that warm the yang and guide the meridians; the auxiliary herb group consists of 24 parts by weight, which includes 7 parts by weight of wolfberry, 6 parts by weight of privet fruit, 6 parts by weight of dodder seed, and 5 parts by weight of lycium bark. The adjuvant herbs for promoting blood circulation and reducing lipids consist of 14 parts by weight, including 8 parts by weight of Angelica sinensis and 6 parts by weight of hawthorn; the guiding herbs for calming the mind and clearing the orifices consist of 14 parts by weight, including 5 parts by weight of Epimedium, 5 parts by weight of Ziziphus jujuba var. spinosa, and 4 parts by weight of chrysanthemum. Among them, the arrow-shaped Astragalus is the dried root of Astragalus mongholicus of the Fabaceae family, with a growth period of more than 3 years, a straight main root shaped like an arrow shaft, a diameter ≥1.5cm, and a quality control standard of astragaloside A content ≥0.12%; The dried roots and rhizomes of the white-flowered Salvia miltiorrhiza cultivar (Lamiaceae family) are described, with robust roots and a tanshinone IIA content ≥0.35% according to quality control standards. The aforementioned male and female human-shaped processed Polygonum multiflorum is the dried tuberous root of Polygonum multiflorum from the Polygonaceae family. Naturally, the two connected tubers resemble a human figure. It undergoes a standardized nine-steaming and nine-drying process to reduce toxicity, with a stilbene glycoside content of ≥2.0% as per quality control standards. The aforementioned *Polygonatum sibiricum* is the dried rhizome of cultivated *Polygonatum sibiricum* (Liliaceae family), with a quality control standard of ≥12% polysaccharide content. The alpine woody warming and meridian guiding combination is a mixture of dried branches and leaves of woody shrubs of the Rhododendron and Rosaceae families in high-altitude cold mountainous areas above 2000m. The core active substance is volatile oil with a volatile oil content of ≥1.8%. After being crushed, it is passed through a 40-80 mesh sieve before use. The weight percentage of medicinal materials is allowed to fluctuate by ±2%; the Chinese medicine composition is prepared by using authentic substitute medicinal materials with equivalent efficacy and equivalent processing techniques.

2. The Sancai Dan herbal composition according to claim 1, characterized in that, The astragaloside A content of the Astragalus membranaceus 'Arrow' is ≥0.12%, the tanshinone IIA content of the Salvia miltiorrhiza 'White Flower' is ≥0.35%, the stilbene glycoside content of the Polygonum multiflorum 'Male and Female Human-shaped Nine-Steamed' is ≥2.0%, the Polygonatum polysaccharide content of the Polygonatum 'Chicken Head' is ≥12%, and the volatile oil content of the Alpine Woody Warming and Guiding Combination is ≥1.8%.

3. The Sancai Dan herbal composition according to claim 1, characterized in that, The alpine woody warming and meridian guiding combination is used after being crushed and passed through a 40-80 mesh sieve. It is neutral in nature and has the effects of relieving stagnation, invigorating the spleen and breaking up greasiness, and sinking and guiding the meridians. It can break up the stagnation in the middle jiao of the nourishing medicinal materials and guide the medicinal power of the whole formula to sink to the five internal organs, the lower jiao and the extremities.

4. A preparation process for concentrated Sancai Dan water-honey pills, characterized in that, Includes the following steps: (1) Low-temperature water extraction: Mix the traditional Chinese medicine composition according to any one of claims 1-3 and add 6-8 times the amount of purified water, soak at 60-70℃ for 1.5-2.5h, and then reflux extract at 80-90℃ twice, each time for 1-1.5h, combine the extracts and filter; (2) Alcohol precipitation purification: Cool the filtered extract to 20-30℃, add 95% ethanol until the alcohol content reaches 55-65%, let it stand at 2-6℃ for 20-28h, take the supernatant and recover the ethanol until there is no alcohol odor, and control the residual ethanol content to ≤0.5%; (3) Vacuum concentration: The supernatant after ethanol recovery is vacuum concentrated at 55-65℃ and -0.07 to -0.09MPa to obtain an extract with a relative density of 1.35-1.40 (measured at 60℃); (4) Making pills: Mix the extract and refined honey at a mass ratio of 1:1.1-1.3, knead them into pills at 40-50℃, and then roll them into strips and cut them into pills to make raw water-honey pills weighing 8-10g each. (5) Drying and packaging: Dry the raw water-honey pills at 45-50℃ until the moisture content is ≤9%, and seal them individually with gold aluminum foil.

5. The preparation process according to claim 4, characterized in that, In step (1), the amount of purified water added is 8 times the total mass of the medicinal materials, the soaking temperature is 65℃, the soaking time is 2h, the reflux extraction temperature is 85℃, and the extraction time is 1.5h each time. The alcohol content in step (2) is 60%, the standing temperature is 4°C, and the standing time is 24h; The vacuum concentration conditions described in step (3) are 60℃ and -0.08MPa, and the relative density of the extract is 1.38 (measured at 60℃). The mass ratio of the extract to refined honey in step (4) is 1:1.2, and the weight of the pills is 9g. The drying temperature in step (5) is 48°C.

6. A method for preparing a dietary therapy condiment composition, characterized in that, The modified traditional Chinese medicine composition according to claim 1 is used, and the modification method is as follows: Remove the male and female human-shaped nine-steamed Polygonum multiflorum, and adjust the following ingredients to 10 parts by weight: Astragalus membranaceus, Salvia miltiorrhiza, Polygonatum sibiricum, Lycium barbarum ... Preparation methods include: mixing and pulverizing the adjusted medicinal materials, passing them through an 80-100 mesh sieve to make a mixed powder, or packaging the mixed powder into 10-15g bags to make a substitute tea, or mixing the mixed powder with edible salt and monosodium glutamate in a mass ratio of 5:3:2 to make a condiment.

7. The preparation method according to claim 6, characterized in that, The fineness of the mixed powder is 80 mesh, and the mixing uniformity RSD is ≤3.0%; The brewing conditions for the substitute tea are as follows: each bag should be brewed with 200-300mL of boiling water, covered and steeped for 8-12 minutes, with an effective ingredient dissolution rate of ≥75%; The amount of the accompanying seasoning added is 0.5-2.0% of the daily dietary intake.

8. A preparation process for a meridian-clearing fluid extract, characterized in that, The modified traditional Chinese medicine composition according to claim 1 is used, and the modification method is as follows: The following ingredients were adjusted: Astragalus membranaceus (arrow shaft) 9 parts by weight, Salvia miltiorrhiza (white flower) 9 parts by weight, Polygonatum sibiricum (chicken head) 11 parts by weight, Alpine woody warming and guiding combination 7 parts by weight, Lycium barbarum 6 parts by weight, Ligustrum lucidum 5 parts by weight, Cuscuta chinensis 5 parts by weight, Angelica sinensis 7 parts by weight, Crataegus pinnatifida 5 parts by weight, Epimedium brevicornu 6 parts by weight, Ziziphus jujuba var. spinosa 3 parts by weight, and Chrysanthemum morifolium 2 parts by weight. The preparation process includes: (1) Ethanol reflux extraction: Add 5-7 times the amount of 60-80% ethanol to the adjusted Chinese herbal composition and reflux extract at 75-85℃ 3 times, each time for 0.8-1.2h. Combine the extracts and filter. (2) Vacuum concentration: The filtered extract was vacuum concentrated at 60-70℃ and -0.08 to -0.10 MPa to a fluid extract with a relative density of 1.20-1.25 (measured at 25℃), and the residual ethanol content was controlled to be ≤0.5%; (3) Dispensing: Dispense the fluid extract into brown glass bottles at a rate of 50-100mL per bottle, seal and store away from light.

9. The preparation process according to claim 8, characterized in that, The concentration of ethanol in step (1) is 70%, the amount added is 6 times the total mass of the medicinal materials, the reflux extraction temperature is 80℃, and the extraction time is 1 hour each time; The vacuum concentration conditions described in step (2) are 65℃ and -0.09MPa, and the relative density of the fluid extract is 1.23 (measured at 25℃). The dispensing specification mentioned in step (3) is 50mL / bottle, and the dispensing process is carried out in a Class 100 clean area.

10. The application of the Sancai Dan herbal composition according to any one of claims 1-3 in the preparation of a product having the effects of promoting qi and blood circulation, clearing the five internal organs, and unblocking the meridians, characterized in that, The products include: Internal pills for treating qi and blood deficiency, disharmony of the five internal organs, stagnation of meridians, post-stroke sequelae rehabilitation, and insomnia; dietary supplements for daily conditioning of the general public; and meridian-clearing fluid extracts for external application to areas of blocked meridians on the body surface. The daily dosage of the oral pills is equivalent to 10-15g of the original medicinal materials, the daily intake of the dietary supplement is equivalent to 5-10g of the original medicinal materials, and the daily application dosage of the external fluid extract is 2-5g / cm² of skin area. The products include concentrated oral medicinal pills, functional substitute teas that are both food and medicine, dietary supplements, external skin therapy fluid extracts, and health care products for sub-health conditions. The applicable treatment scenarios include deficiency of qi and blood, disharmony of the five internal organs, stagnation of meridians, rehabilitation of stroke sequelae, and daily maintenance for people with irritability and insomnia.

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