A traditional Chinese medicine composition for tonifying qi and nourishing blood, a preparation method thereof and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for tonifying qi and nourishing blood and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines, and comprises the following components in mass parts: 28-38 parts of rhizoma polygonati, 15-24 parts of ficus pumila var. obliqua, 12-18 parts of sargassum fusiforme, 12-18 parts of radix codonopsis, 8-12 parts of rubus chingii hu, and 5-11 parts of ramulus cinnamomi. The rhizoma polygonati, the ficus pumila var. obliqua, the sargassum fusiforme, the radix codonopsis, the rubus chingii hu and the ramulus cinnamomi are combined according to the specific mass parts, the materials of health-care food or food with the same origin are selected, the rhizoma polygonati, the ficus pumila var. obliqua, the sargassum fusiforme, the radix codonopsis, the rubus chingii hu and the ramulus cinnamomi are matched and interacted, one monarch, two ministers, two assistants and one messenger are obtained, the rhizoma polygonati is the monarch, the ficus pumila var. obliqua and the sargassum fusiforme are the ministers, the sargassum fusiforme is the assistant, and the ramulus cinnamomi is the minister, so that the traditional Chinese medicine composition with excellent effects of tonifying qi and nourishing blood is obtained, the prescription function is clear, there is no compatibility contraindication, the edible safety is effective, and the traditional Chinese medicine composition also has excellent anti-inflammatory effects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a qi-tonifying and blood-nourishing traditional Chinese medicine composition, its preparation method, and its application. Background Technology

[0002] The health of contemporary young people is receiving increasing attention. Due to significant social and life pressures, the dietary structure and lifestyle of Chinese youth have also changed. "Replenishing qi and blood, eating tonics" has gradually become a common phrase among young people. As a result, there is a joking and subconscious "acceptance" of health practices such as "soaking goji berries in a thermos or adding ginseng to cola." The market for health supplements among young people is also gradually emerging.

[0003] According to survey results, the market size of tonics and nutritional products exceeded 260 billion yuan in 2021, accounting for 12% of the total food manufacturing industry's 2.1268 trillion yuan. This indicates that the era of tonics is arriving in the food industry. According to a report on the nutritional consumption trends of Generation Z released by Xinhua News Agency and other sources, young people aged 18-35 have become the main force in the health and wellness industry, and tonic foods are penetrating various food sectors. Supported by China's rich cultural heritage of food therapy and the rise of traditional Chinese health practices, tonics are finding broader growth potential.

[0004] When Qi and blood are abundant, no disease arises; when Qi and blood are deficient, all diseases arise. Qi and blood are the basic substances that constitute the human body and maintain its life activities. In traditional Chinese medicine, replenishing Qi and blood can strengthen bodily functions, improve physical fitness, and prevent the invasion of some diseases. Common symptoms such as hypoglycemia and pale complexion are often caused by insufficient Qi and blood. Therefore, how to replenish Qi and nourish blood has become a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the existing technology and provide a traditional Chinese medicine composition for replenishing qi and nourishing blood, its preparation method and application. This invention selects raw materials that are both food and medicine or can be used in health food to obtain a traditional Chinese medicine composition with excellent qi and blood replenishing effects. The composition has clear functions, no contraindications, and is safe and effective for consumption. At the same time, the traditional Chinese medicine composition also has excellent anti-inflammatory effects.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0007] A traditional Chinese medicine composition for replenishing qi and nourishing blood includes the following components in parts by weight: 28-38 parts Polygonatum sibiricum, 15-24 parts Ficus hirta, 12-18 parts Sargassum fusiforme, 12-18 parts Codonopsis pilosula, 8-12 parts Rubus idaeus, and 5-11 parts Cinnamomum cassia.

[0008] The traditional Chinese medicine composition of this invention contains Polygonatum sibiricum, which contains polysaccharides, saponins, flavonoids, and other components, and has the effects of moistening the lungs and relieving dryness and resolving phlegm, relieving cough and asthma, tonifying the kidneys and calming the mind, replenishing deficiency and invigorating qi, and tonifying the spleen and invigorating qi. Ficus hirta contains coumarins, volatile oils, steroids, flavonoids, polyphenols, and other components, and has the effects of strengthening the spleen to resolve dampness, tonifying the lungs to promote qi circulation, promoting blood circulation, and enhancing the body's immunity. It also has the effects of strengthening the spleen and resolving dampness, invigorating qi and consolidating the exterior, and has antibacterial, antiviral, and anti-inflammatory effects. Sargassum fusiforme is rich in polysaccharides, cellulose, and other components. B vitamins, alginic acid, mannitol, and amino acids promote hematopoiesis and enhance immune function. They also have heat-clearing, detoxifying, lung-moistening, and cough-relieving effects, eliminating toxins and heat in the body, moisturizing the lungs, and relieving cough and respiratory inflammation. Codonopsis pilosula contains codonopsis glycosides, glucose, inulin, polysaccharides, and codonopsis alkaloids, and is used for spleen and lung qi deficiency, poor appetite and fatigue, cough and wheezing, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to fluid depletion, and internal heat and thirst. Raspberries contain protein, amino acids, and vitamins. Raspberries contain organic acids, minerals, and other components. They effectively nourish the liver and kidneys, acting as a yin-nourishing medicine, and assist in regulating yin-yang balance while replenishing qi and blood. Cinnamon twigs contain volatile oils, phenols, organic acids, polysaccharides, glycosides, coumarins, and tannins, possessing the effects of inducing sweating and relieving muscle tension, warming and unblocking meridians, warming and tonifying the spleen and stomach, promoting the generation of yang qi, improving yang deficiency, assisting yang qi transformation, and calming and descending qi. They can harmonize other medicines and enhance their efficacy. This invention creatively combines Polygonatum sibiricum, Ficus hirta, Sargassum fusiforme, Codonopsis pilosula, raspberries, and cinnamon twigs according to the above... By combining specific components of the above-mentioned ingredients, and selecting raw materials that are both medicinal and edible or suitable for health food, and utilizing the synergistic effects of Polygonatum sibiricum, Ficus hirta, Sargassum fusiforme, Codonopsis pilosula, Rubus idaeus, and Cinnamomum cassia, a traditional Chinese medicine composition with excellent qi-tonifying and blood-nourishing effects was obtained. The composition has a clear function, no contraindications, and is safe and effective for consumption. At the same time, the traditional Chinese medicine composition also has excellent anti-inflammatory effects.

[0009] It should be noted that the raw materials involved in this invention are traditional Chinese medicines included in the 2020 edition of the Chinese Pharmacopoeia and meet the quality requirements of the pharmacopoeia.

[0010] The dosage of Polygonatum is 28 to 38 parts, for example, it can be 28 parts, 30 parts, 32 parts, 34 parts, 35 parts, 36 parts, 38 parts or any two of these values.

[0011] The amount of the five-finger peach is 15 to 24 parts, for example, it can be 15 parts, 16 parts, 18 parts, 20 parts, 22 parts, 22 parts, 24 parts or any two of these values.

[0012] The amount of Sargassum fusiforme used is 12 to 18 parts, for example, it can be 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts or any two of these values.

[0013] The dosage of Codonopsis pilosula is 12 to 18 parts, for example, it can be 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts or any two of these values.

[0014] The amount of raspberries used is 8 to 12 parts, for example, it can be 8 parts, 9 parts, 10 parts, 11 parts, 12 parts or any two of these values.

[0015] The amount of cinnamon twigs used is 5 to 11 parts, for example, it can be 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts or any two of these values.

[0016] In one embodiment, the components include the following parts by weight: 30-35 parts Polygonatum sibiricum, 18-22 parts Ficus hirta, 14-17 parts Sargassum fusiforme, 14-17 parts Codonopsis pilosula, 9-11 parts Rubus idaeus, and 6-9 parts Cinnamomum cassia. In particular, when the dosage of each raw material is within this range, the synergistic effect is more obvious, the compatibility is better, and the anti-inflammatory effect and blood-tonifying and qi-boosting effect are more significantly improved, resulting in a better overall effect. In subsequent experimental verification, within this range, the content of WBC, RBC, and PLC is further increased, and IL-1β is more effectively inhibited.

[0017] In one embodiment, the components include the following parts by weight: 32 parts Polygonatum sibiricum, 20 parts Ficus hirta, 15 parts Sargassum fusiforme, 15 parts Codonopsis pilosula, 10 parts Rubus idaeus, and 8 parts Cinnamomum cassia. In particular, when the amount of each ingredient is such, it has the best anti-inflammatory effect and blood-tonifying and qi-boosting effect.

[0018] In one embodiment, the ratio of the sum of the masses of Codonopsis pilosula and Raspberry to the mass of Prunus armeniaca is (1 to 1.6):1, for example, it can be 1:1, 1.1:1, 1.2:1, 1.3:1, 1.4:1, 1.5:1, 1.6:1 or any range of two of these values. The inventors of this invention have discovered that the *Ficus hirta* contains coumarins, volatile oils, steroids, flavonoids, polyphenols, and other components; *Codonopsis pilosula* contains codonopsis glycosides, glucose, inulin, polysaccharides, codonopsis alkaloids, and other components; and *Raspberry* contains proteins, amino acids, vitamins, organic acids, minerals, and other components. The inventors speculate that during the subsequent preparation process, the volatile oils of *Ficus hirta* and the organic acids of *Raspberry* can improve the solubility of other components, especially codonopsis glycosides and codonopsis alkaloids. Glucose, inulin, and polysaccharides can form hydrogen bonds, charge transfers, and covalent bonds with other components in the system. During the percolation process, the effective components are fully percolated, thus facilitating the synergistic effect of each component and effectively promoting the dissolution of functional substances in the medicinal materials, thereby enhancing the overall efficacy of the medicinal composition.

[0019] In one embodiment, the ratio of the sum of the masses of Sargassum fusiforme and Cinnamomum cassia to the mass of Polygonatum sibiricum is 1:(1-1.8), for example, it can be 1:1, 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8 or any range of two values ​​therein. The inventors of this invention have found that Polygonatum sibiricum contains polysaccharides, saponins, flavonoids and other components; Sargassum fusiforme is rich in polysaccharides, cellulose, B vitamins, alginic acid, mannitol and amino acids and other components; Cinnamomum cassia contains volatile oils and phenols. The composition includes compounds such as phytoestrogens, organic acids, polysaccharides, glycosides, coumarins, and tannins. The inventors speculate that when the ratio of the sum of the masses of Sargassum fusiforme and cinnamon twigs to the mass of Polygonatum sibiricum satisfies this relationship, the volatile oil in cinnamon twigs and the alcohols in Sargassum fusiforme can effectively improve the solubility of each component and increase the extraction rate of the active ingredients. This allows for better extraction and utilization during enzymatic hydrolysis and fermentation, facilitating the synergistic effect of each component and effectively promoting the dissolution of active substances in traditional Chinese medicine, thereby enhancing the overall efficacy of the traditional Chinese medicine composition.

[0020] This invention also provides a method for preparing a traditional Chinese medicine composition for replenishing qi and nourishing blood, comprising the following steps:

[0021] (1) Powder the five-finger peach, codonopsis and raspberry and mix them evenly to obtain the first mixture; extract the first mixture by percolation with ethanol solution, concentrate under reduced pressure to obtain percolate;

[0022] (2) After crushing Polygonatum sibiricum, Sargassum fusiforme and Cinnamomum cassia, mix them evenly to obtain a second mixture; add the second mixture, cellulase and β-glucanase to water, and enzymatically hydrolyze to obtain an enzymatic hydrolysate; inoculate Lactobacillus plantarum into the enzymatic hydrolysate, ferment, sterilize, and obtain a fermentation broth;

[0023] (3) Mix the obtained percolate and fermentation liquid evenly, filter, and obtain a traditional Chinese medicine composition for replenishing qi and nourishing blood.

[0024] The inventors of this invention discovered that most existing preparation processes for traditional Chinese medicine compositions employ alcohol extraction or water extraction. This invention first prepares the traditional Chinese medicine composition using alcohol and water extraction. However, the inventors found that while the traditional Chinese medicine compositions obtained through alcohol and water extraction have certain blood-tonifying and qi-boosting effects, their efficacy still needs improvement. The inventors speculate that this may be due to the low degree of extraction or conversion of effective components and nutrients through alcohol or water extraction, making it difficult for the product to exert its due medicinal value and therapeutic effect. Therefore, the inventors seek to develop new extraction processes to extract or convert effective components and nutrients.

[0025] The inventors of this invention discovered through extensive research that by pulverizing five-finger peach, codonopsis, and raspberry and percolating with an ethanol solution, then mixing with polygonatum, whey, and cinnamon twig, and sequentially enzymatically hydrolyzing and fermenting, the effects of blood-tonifying and qi-boosting, as well as anti-inflammatory properties, are significantly improved. The method of this invention promotes the extraction or transformation of effective components and nutrients. Furthermore, this invention creatively separates the extraction of polygonatum, whey, and cinnamon twig from five-finger peach, codonopsis, and raspberry, which promotes the interaction between the components, improves their solubility, fully leverages their respective advantages, and achieves an ideal synergistic effect, thereby enhancing the overall efficacy of the traditional Chinese medicine composition.

[0026] The inventors speculate that the process involves percolating five-finger peach, codonopsis, and raspberry. The volatile oil of five-finger peach and the organic acids of raspberry can enhance the solubility of other components, especially codonopsis glycosides and codonopsis alkaloids. Glucose, inulin, and polysaccharides form hydrogen bonds, charge transfers, and covalent bonds with other components in the system. During percolation, the effective components are fully extracted, thus facilitating the synergistic effect of each component. After mixing polygonatum, whey, and cinnamon twigs, enzymatic hydrolysis and fermentation are carried out sequentially. During enzymatic hydrolysis, cellulase and β-carotene... The combination of glucanase and specific enzymes can effectively break down cell walls and decompose fibrous components, maximizing the release of polysaccharides from Polygonatum sibiricum, Sargassum fusiforme, Cinnamomum cassia, and flavonoids. The volatile oils in Cinnamomum cassia and the alcohols in Sargassum fusiforme can effectively improve the solubility of each component and increase the extraction rate of active ingredients, allowing them to be better extracted and utilized during enzymatic hydrolysis and fermentation. This facilitates the synergistic effect of each component, effectively promotes the dissolution of active substances in Chinese medicinal materials, and thus enhances the overall efficacy of the Chinese medicine composition.

[0027] In one embodiment, the mass ratio of the first mixture to the ethanol solution is 1:(4 to 10), for example, it can be 1:4, 1:5, 1:6, 1:7, 1:8, 1:9, 1:10 or any range of two of these values.

[0028] In one embodiment, the mass concentration of the ethanol solution is 50-70%, for example, it can be 50%, 55%, 60%, 65%, 70%, or any two of these values.

[0029] In one embodiment, the mass ratio of the second mixture, cellulase, β-glucanase, and water is 1:(0.005-0.03):(0.005-0.02):(4-10). The inventors of this invention have discovered that different enzymes produce different results.

[0030] In one embodiment, the inoculum amount of *Lactobacillus plantarum* is 1 to 4 wt%, for example, it can be 1 wt%, 1.5 wt%, 2 wt%, 2.5 wt%, 3 wt%, 3.5 wt%, 4 wt%, or any two of these values.

[0031] In one embodiment, the *Lactobacillus plantarum* described in this invention is a standard strain of GB4789.28, purchased from Guangdong Provincial Microbial Culture Collection Center, GDMCC NO: 1.2685.

[0032] In one embodiment, the enzymes used in this invention were all purchased from Shanghai Lanji Technology Development Co., Ltd.

[0033] In one embodiment, the temperature of the percolation extraction is 40 to 50°C, for example, it can be 40°C, 42°C, 45°C, 48°C, 50°C or any two of these values.

[0034] In one embodiment, the enzymatic hydrolysis temperature is 45–55°C, for example, it can be 40°C, 42°C, 45°C, 48°C, 50°C or any two of these values.

[0035] In one embodiment, the enzymatic hydrolysis time is 3 to 6 hours, for example, it can be 3 hours, 4 hours, 5 hours, 6 hours or any two of these values.

[0036] In one embodiment, the fermentation time is 32 to 60 hours, for example, it can be 32 hours, 35 hours, 40 hours, 45 hours, 48 ​​hours, 50 hours, 55 hours, 60 hours or any two of these values.

[0037] The present invention also provides the application of a traditional Chinese medicine composition in the preparation of cough treatment products and / or qi-tonifying and blood-nourishing products, wherein the products include food, medicine or health products.

[0038] It should be noted that the products (food, medicine or health products) described in this invention are made from the above-mentioned traditional Chinese medicine composition and pharmaceutically or food-acceptable excipients or additives.

[0039] In one embodiment, the excipients include, but are not limited to, at least one of disintegrants, fillers, lubricants, suspending agents, sweeteners, binders, flavoring agents, preservatives, and matrices.

[0040] In one embodiment, the disintegrant includes, but is not limited to, starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, croscarmellose, low-substituted hydroxypropyl cellulose, croscarmellose sodium, and combinations thereof.

[0041] In one embodiment, the filler includes, but is not limited to, starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, sucrose, and combinations thereof.

[0042] In one embodiment, the lubricant includes, but is not limited to, magnesium stearate, sodium dodecyl sulfate, talc, silica, and combinations thereof.

[0043] In one embodiment, the filler includes, but is not limited to, starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, sucrose, and combinations thereof.

[0044] In one embodiment, the suspending agent includes, but is not limited to, polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, and combinations thereof.

[0045] In one embodiment, the sweetener includes, but is not limited to, sodium saccharin, aspartame, sucrose, cyclamate, glycyrrhetinic acid, and combinations thereof.

[0046] In one embodiment, the adhesive includes, but is not limited to, starch paste, polyvinylpyrrolidone, hydroxypropyl methylcellulose, and combinations thereof.

[0047] In one embodiment, the flavoring agent includes sweeteners, flavorings, and combinations thereof.

[0048] In one embodiment, the preservative (in a prescribed amount) includes, but is not limited to, parabens, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chlorethidine acetate, eucalyptus oil, and combinations thereof.

[0049] In one embodiment, the matrix includes, but is not limited to, PEG1000, PEG2000, PEG4000, PEG6000, insect wax, and other combinations thereof.

[0050] The beneficial effects of this invention are as follows: This invention combines Polygonatum sibiricum, Ficus hirta, Sargassum fusiforme, Codonopsis pilosula, Rubus idaeus, and Cinnamomum cassia according to the above-mentioned specific mass proportions, selects raw materials that are both medicinal and edible or can be used in health food, and utilizes the synergistic effects of Polygonatum sibiricum, Ficus hirta, Sargassum fusiforme, Codonopsis pilosula, Rubus idaeus, and Cinnamomum cassia to obtain a traditional Chinese medicine composition with excellent qi-tonifying and blood-nourishing effects. The formula has a clear function, no contraindications, and is safe and effective for consumption. At the same time, the traditional Chinese medicine composition also has excellent anti-inflammatory effects. Detailed Implementation

[0051] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions in the embodiments of this application will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0052] In this application, the technical features described in an open-ended manner include both closed technical solutions consisting of the listed features and open technical solutions that include the listed features.

[0053] In this application, numerical ranges are referred to as continuous unless otherwise specified, and include the minimum and maximum values ​​of the range, as well as every value between the minimum and maximum values. Furthermore, when the range refers to integers, it includes every integer between the minimum and maximum values ​​of the range. Additionally, when multiple ranges are provided to describe a feature or characteristic, the ranges may be merged. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges to which they are incorporated.

[0054] In this application, there are no particular restrictions on the specific dispersion and mixing methods.

[0055] Unless otherwise specified, all experiments were conducted under standard conditions or conditions recommended by the manufacturer. All active pharmaceutical ingredients (APIs) and excipients, as well as reagents and instruments whose manufacturers are not specified, were commercially available products. Furthermore, all components used in parallel experiments were of the same type. Unless otherwise stated, all percentages, ratios, proportions, or parts are by mass.

[0056] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0057] Examples 1-9, Comparative Examples 1-2

[0058] The formulations of Examples 1-9 and Comparative Examples 1-2 are shown in Table 1 (all figures are parts by mass), where A represents the ratio of the total mass of Codonopsis pilosula and Raspberry to the mass of Ficus hirta, and B represents the ratio of the total mass of Sargassum fusiforme and Cinnamomum cassia to the mass of Polygonatum sibiricum.

[0059] The preparation method of the Qi-tonifying and blood-nourishing traditional Chinese medicine composition described in Examples 1-9 includes the following steps:

[0060] (1) Grind five-finger peach, codonopsis and raspberry into 100 mesh and mix them evenly to obtain the first mixture; add the first mixture into the percolator, compact and fix it, then add 60wt% ethanol solution to the percolator, the mass of the ethanol solution is 6 times that of the first mixture, soak for 24h, after soaking, open the percolator valve, percolate at 45℃, the percolation speed is 2mL / s, collect the liquid, concentrate under reduced pressure until there is no ethanol smell, to obtain the percolate;

[0061] (2) Polygonatum sibiricum, Sargassum fusiforme, and Cinnamomum cassia are pulverized to 100 mesh and then mixed evenly to obtain a second mixture; the second mixture, cellulase, and β-glucanase are added to water, and the mixture is enzymatically hydrolyzed at 50°C for 5 hours to obtain an enzymatic hydrolysate; Lactobacillus plantarum is inoculated into the enzymatic hydrolysate, fermented at 38°C for 48 hours, and sterilized at 95°C for 10 minutes to obtain a fermentation broth; the mass ratio of the second mixture, cellulase, β-glucanase, and water is 1:0.02:0.01:6; the inoculation amount of Lactobacillus plantarum is 2wt%;

[0062] (3) Mix the percolate and fermentation liquid obtained above evenly, filter, and obtain the traditional Chinese medicine composition.

[0063] Comparative Example 3

[0064] The difference between Comparative Example 3 and Example 1 is that Comparative Example 3 does not contain Prunus pubescens, but all other aspects are the same.

[0065] Comparative Example 4

[0066] The difference between Comparative Example 4 and Example 1 is that Comparative Example 4 does not contain Sargassum fusiforme, but all other aspects are the same.

[0067] Comparative Example 5

[0068] The difference between Comparative Example 5 and Example 1 is that Comparative Example 5 does not contain Codonopsis pilosula, but all other aspects are the same.

[0069] Comparative Example 6

[0070] The difference between Comparative Example 6 and Example 1 is that Comparative Example 6 does not contain raspberries, but they are otherwise the same.

[0071] Comparative Example 7

[0072] The difference between Comparative Example 7 and Example 1 is that Comparative Example 7 does not contain Prunus pubescens, and Comparative Example 7 uses an equal amount of Citrus medica to replace Prunus pubescens, while everything else is the same.

[0073] Comparative Example 8

[0074] The difference between Comparative Example 8 and Example 1 is that Comparative Example 8 does not contain Sargassum fusiforme, and Comparative Example 8 uses an equal amount of Poria cocos to replace Sargassum fusiforme, while everything else is the same.

[0075] Comparative Example 9

[0076] The difference between Comparative Example 9 and Example 1 is that Comparative Example 9 does not contain Codonopsis pilosula, and Comparative Example 9 uses an equal amount of Dioscorea opposita to replace Codonopsis pilosula, while everything else is the same.

[0077] Comparative Example 10

[0078] The difference between Comparative Example 10 and Example 1 is that Comparative Example 10 does not contain raspberries, and Comparative Example 10 uses an equal amount of wolfberries to replace raspberries, while everything else is the same.

[0079] Table 1

[0080]

[0081] Table 2

[0082]

[0083]

[0084] Comparative Example 11

[0085] The difference between Comparative Example 11 and Example 1 is that the preparation method of the traditional Chinese medicine composition is different, but everything else is the same.

[0086] The preparation method of the Qi-tonifying and blood-nourishing traditional Chinese medicine composition of Comparative Example 11 includes the following steps:

[0087] (1) Powder five-finger peach, codonopsis, raspberry, polygonatum, whelk and cinnamon twig to 100 mesh and mix evenly to obtain the first mixture; add the first mixture to the percolator, compact and fix it, then add 60wt% ethanol solution to the percolator, the mass of the ethanol solution is 6 times that of the first mixture, soak for 24h, after soaking, open the percolator valve, percolate at 45℃, the percolation rate is 2mL / s, collect the liquid, concentrate under reduced pressure until there is no ethanol smell, obtain percolate, filter, and obtain the Chinese medicine composition.

[0088] Comparative Example 12

[0089] The difference between Comparative Example 12 and Example 1 is that the preparation method of the traditional Chinese medicine composition is different, but everything else is the same.

[0090] The preparation method of the Qi-tonifying and blood-nourishing traditional Chinese medicine composition described in Comparative Example 12 includes the following steps:

[0091] (1) Five-finger peach, codonopsis, raspberry, polygonatum, whey, and cinnamon twig are pulverized to 100 mesh and mixed evenly to obtain a second mixture; the second mixture, cellulase, and β-glucanase are added to water, and the mixture is enzymatically hydrolyzed at 50℃ for 5 hours to obtain an enzymatic hydrolysate; Lactobacillus plantarum is inoculated into the enzymatic hydrolysate and fermented at 38℃ for 48 hours to obtain a fermentation broth, which is sterilized at 95℃ for 10 minutes and filtered to obtain a traditional Chinese medicine composition; the mass ratio of the second mixture, cellulase, β-glucanase, and water is 1:0.02:0.01:6; the inoculation amount of Lactobacillus plantarum is 2wt%;

[0092] Comparative Example 13

[0093] The difference between Comparative Example 13 and Example 1 is that the preparation method of the traditional Chinese medicine composition is different, but everything else is the same.

[0094] The preparation method of the Qi-tonifying and blood-nourishing traditional Chinese medicine composition described in Comparative Example 13 includes the following steps:

[0095] (1) Powder the following ingredients to 100 mesh and mix them evenly to obtain the first mixture. Add the first mixture to 6 times the total mass of 80wt% ethanol aqueous solution and soak at 25℃ for 18h. While soaking, sonicate at 200w power. After soaking, concentrate under reduced pressure until there is no ethanol smell, filter, and obtain the Chinese medicine composition.

[0096] Comparative Example 14

[0097] The difference between Comparative Example 14 and Example 1 is that the preparation method of the traditional Chinese medicine composition is different, but everything else is the same.

[0098] The preparation method of the Qi-tonifying and blood-nourishing traditional Chinese medicine composition described in Comparative Example 14 includes the following steps:

[0099] (1) Powder the five-finger peach, codonopsis, raspberry, polygonatum, whey and cinnamon twig to 100 mesh and mix them evenly to obtain the first mixture. Add the first mixture to 6 times the total mass of water and soak it twice at 45℃ for 3 hours each time. While soaking, use 200W power to sonicate. After soaking, filter to obtain the Chinese medicine composition.

[0100] Comparative Example 15

[0101] The difference between Comparative Example 15 and Example 1 is that the preparation method of the traditional Chinese medicine composition is different, but everything else is the same.

[0102] The preparation method of the qi-tonifying and blood-nourishing traditional Chinese medicine composition includes the following steps:

[0103] (1) Grind five-finger peach, codonopsis and raspberry into 100 mesh and mix them evenly to obtain the first mixture; add the first mixture into the percolator, compact and fix it, then add 60wt% ethanol solution to the percolator, the mass of the ethanol solution is 6 times that of the first mixture, soak for 24h, after soaking, open the percolator valve, percolate at 45℃, the percolation speed is 2mL / s, collect the liquid, concentrate under reduced pressure until there is no ethanol smell, to obtain the percolate;

[0104] (2) Polygonatum sibiricum, Sargassum fusiforme, and Cinnamomum cassia are pulverized to 100 mesh and then mixed evenly to obtain a second mixture; the second mixture, pectinase, and flavor protease are added to water, and the mixture is enzymatically hydrolyzed at 50°C for 5 hours to obtain an enzymatic hydrolysate; Lactobacillus plantarum is inoculated into the enzymatic hydrolysate, fermented at 38°C for 48 hours, and sterilized at 95°C for 10 minutes to obtain a fermentation broth; the mass ratio of the second mixture, pectinase, flavor protease, and water is 1:0.02:0.01:6; the inoculation amount of Lactobacillus plantarum is 2wt%;

[0105] (3) Mix the percolate and fermentation liquid obtained above evenly, filter, and obtain the traditional Chinese medicine composition.

[0106] Comparative Example 16

[0107] The difference between Comparative Example 16 and Example 1 is that the preparation method of the traditional Chinese medicine composition is different, but everything else is the same.

[0108] The preparation method of the qi-tonifying and blood-nourishing traditional Chinese medicine composition includes the following steps:

[0109] (1) Pulverize Polygonatum, Sargassum fusiforme, and Cinnamomum cassia to 100 mesh and mix them evenly to obtain the first mixture; add the first mixture to the percolator, compact and fix it, then add 60wt% ethanol solution to the percolator, the mass of the ethanol solution being 6 times that of the first mixture, and soak for 24 hours. After soaking, open the percolator valve and percolate at 45℃ at a percolation rate of 2mL / s. Collect the liquid and concentrate it under reduced pressure until there is no ethanol smell to obtain the percolate.

[0110] (2) Five-finger peach, codonopsis, and raspberry are pulverized to 100 mesh and mixed evenly to obtain a second mixture; the second mixture, cellulase, and β-glucanase are added to water, and the mixture is enzymatically hydrolyzed at 50℃ for 5 hours to obtain an enzymatic hydrolysate; Lactobacillus plantarum is inoculated into the enzymatic hydrolysate, fermented at 38℃ for 48 hours, and sterilized at 95℃ for 10 minutes to obtain a fermentation broth; the mass ratio of the second mixture, cellulase, β-glucanase, and water is 1:0.02:0.01:6; the inoculation amount of Lactobacillus plantarum is 2wt%;

[0111] (3) Mix the percolate and fermentation liquid obtained above evenly, filter, and obtain the traditional Chinese medicine composition.

[0112] Test case

[0113] Test Example 1: Verification of Qi-tonifying and Blood-nourishing Effects

[0114] Three hundred and thirty-six male NIH mice weighing 18–22 g were selected and acclimatized for one week. These mice were then divided into 28 groups of 12 mice each: a blank control group, a model control group, a positive control group, and experimental groups 1–25. All mice were administered the drug via gavage at a dose of 20 ml / kg once daily. The model control group and the blank control group were administered an equal volume of physiological saline via gavage. The positive control group received Compound Donkey-hide Gelatin Oral Liquid. Experimental groups 1–24 were administered the traditional Chinese medicine compositions of Examples 1–9 and Comparative Examples 1–16, respectively. Before modeling, blood was collected from the orbital plexus of each mouse group, and normal blood cell counts were measured. Except for the normal control group, the other groups underwent phlebotomy of the retro-orbital venous plexus for seven consecutive days, at a dose of 0.5 ml per day, to create an acute blood loss anemia model. From the day of modeling, the respective drug groups were administered the corresponding drug via gavage for seven consecutive days.

[0115] Observation indicators: One hour after the last administration, blood was collected from the eyes of each group (12 animals in each group, the maximum and minimum values ​​were removed, and the average value was taken). After blood collection, WBC, RBC and PLT were measured by an automated whole blood analyzer. The test results are shown in Table 3.

[0116] Table 3

[0117]

[0118]

[0119] Note: Compared with the model group, *P<0.05, **P<0.01; compared with the blank group, #P<0.05, ##P<0.01.

[0120] Test Example 2: Verification of Anti-inflammatory Effect

[0121] One control group and 25 experimental groups were set up, with 10 wells in each group. The average value of the test results was taken. The control group consisted of P. acnes without the Chinese medicine composition; the experimental groups consisted of P. acnes with the Chinese medicine composition. The Chinese medicine compositions in the experimental groups were the Chinese medicine compositions of the examples and comparative examples, respectively.

[0122] Take THP-1 during the exponential growth phase, at 1×10 6 The cells were inoculated at a density of [number] cells / mL into 96-well culture plates, and a traditional Chinese medicine composition diluted with RPMI 1640 medium to a final concentration of 10 g / L was added. A live bacterial suspension was prepared from *P. acnes* cultured anaerobically for 72 h and added to the 96-well culture plates at a bacterial-to-THP-1 ratio of 100:1. The model group consisted of cells incubated without the traditional Chinese medicine composition plus *P. acnes*, while the blank control group consisted of cells incubated with only PBS solution. After 24 h of culture, the IL-1β content in the cell supernatant was measured using ELISA. The results are shown in Table 4.

[0123] IL-1β inhibition rate = (IL-1β content in control group - IL-1β content in experimental group) / IL-1β content in control group × 100%.

[0124] Table 4

[0125]

[0126]

[0127] As can be seen from Tables 3 and 4, the traditional Chinese medicine composition described in this invention has excellent blood-tonifying, qi-boosting, and anti-inflammatory effects. It can significantly increase the content of WBC, RBC, and PLC, and effectively inhibit IL-1β. In mouse experiments using the scheme of this invention, WBC ≥ 16.7 × 10⁻⁶. 9 / L, RBC≥7.3×10 12 / L, PLT≥820×10 9 / L, and when the regimens of Examples 1 to 5 are used, the blood-tonifying and qi-boosting effects are better than those of the positive control group, and the IL-1β inhibition rate is ≥70%.

[0128] Comparing the examples, control group, and model group, it can be seen that the traditional Chinese medicine composition of the present invention significantly increased the content of WBC, RBC, and PLC compared with the model group, and effectively inhibited IL-1β; and the blood-tonifying and qi-boosting effects of the examples were close to those of the control group, and the effects were significantly better than those of the positive control group.

[0129] Comparing Examples 1-3 with Examples 6-7, it can be seen that by controlling the dosage of each raw material to be: 30-35 parts Polygonatum sibiricum, 18-22 parts Ficus hirta, 14-17 parts Sargassum fusiforme, 14-17 parts Codonopsis pilosula, 9-11 parts Rubus idaeus, and 6-9 parts Cinnamomum cassia, the synergistic effect is more obvious, which can more significantly improve the blood-tonifying and qi-boosting and anti-inflammatory effects, further increase the content of WBC, RBC, and PLC, and effectively inhibit IL-1β.

[0130] Comparing Examples 1 and 8-9, it can be seen that by controlling the ratio of the sum of the masses of Codonopsis pilosula and Rubus idaeus to the mass of Ficus hirta, the synergistic effect of the present invention is more obvious, which can more significantly improve blood and qi replenishment, and further increase the content of WBC, RBC, and PLC. When the ratio of the sum of the masses of Codonopsis pilosula and Rubus idaeus to the mass of Ficus hirta deviates from the range of the present invention, the blood and qi replenishment effect is worse than that of the positive control group.

[0131] Comparing Examples 1-5 with Examples 6-9, it can be seen that when the ratio of the sum of the masses of Codonopsis pilosula and Rubus idaeus to the mass of Ficus hirta is (1-1.6):1, and the ratio of the sum of the masses of Sargassum fusiforme and Cinnamomum cassia to the mass of Polygonatum sibiricum is 1:(1-1.8), the obtained traditional Chinese medicine composition has a more ideal synergistic effect and better overall performance.

[0132] Comparing Example 1 with Comparative Examples 1-2, it can be seen that when the dosage of Polygonatum sibiricum, Ficus hirta, Sargassum fusiforme, Codonopsis pilosula, Rubus idaeus, and Cinnamomum cassia deviates from the scope of the present invention, the compatibility effect of the present invention decreases, and antagonistic effects may occur, which in turn leads to a significant decrease in the blood-tonifying, qi-boosting, and anti-inflammatory effects.

[0133] Comparing Example 1 with Comparative Examples 9-10, it can be seen that the Polygonatum sibiricum, Ficus hirta, Sargassum fusiforme, Codonopsis pilosula, Rubus idaeus, and Cinnamomum cassia of the present invention have significant synergistic effects. The blood-tonifying and qi-boosting effects of the present invention are achieved through the combined action of Polygonatum sibiricum, Ficus hirta, Sargassum fusiforme, Codonopsis pilosula, Rubus idaeus, and Cinnamomum cassia. The absence of any one of Ficus hirta, Sargassum fusiforme, Codonopsis pilosula, or Rubus idaeus will result in a significant decrease in the effect. Furthermore, when the ingredients in the formula of the present invention are replaced with other ingredients, the blood-tonifying, qi-boosting, and anti-inflammatory effects will also decrease significantly.

[0134] Comparing Example 1 with Comparative Examples 11-16, it can be seen that when the formulation system of the present invention adopts the specific preparation process of the present invention, the blood-tonifying and qi-boosting effects are significantly improved. However, when conventional water extraction, alcohol extraction or one-step preparation is used, it is difficult to exert the ideal effect, resulting in a significant decrease in the blood-tonifying, qi-boosting and anti-inflammatory effects.

[0135] Test Example 3

[0136] Safety test

[0137] 1. One hundred Balb / c mice aged 6-8 weeks and weighing 18-22g were randomly divided into 10 groups (n=10 per group, 5 males and 5 females), namely a blank control group and an experimental group (containing the traditional Chinese medicine compositions of Examples 1-9 of this invention). Before the experiment, the mice were fasted but allowed free access to water for 16 hours. The blank control group was continuously administered physiological saline by gavage, while the experimental group was administered the traditional Chinese medicine compositions of Examples 1-6 by gavage. Examples 1-9 were administered at the maximum tolerated dose (maximum dose that can be administered by gavage, 400mg / kg / day), converted to a human clinical dose, twice a day for one day only. The condition of the mice was observed after each gavage, and the number of dead mice was counted. Mice that did not die after 48 hours were continuously observed for 2 weeks. The results showed that no deaths occurred in the experimental group, and the condition of the mice was significantly better than that in the blank control group. Therefore, it is demonstrated that the product provided by this invention can be safely used as food or medicine.

[0138] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A traditional Chinese medicine composition for tonifying qi and nourishing blood, characterized in that, It is made from the following components by weight: 28-38 parts Polygonatum sibiricum, 15-24 parts Ficus hirta, 12-18 parts Sargassum fusiforme, 12-18 parts Codonopsis pilosula, 8-12 parts Rubus idaeus, and 5-11 parts Cinnamomum cassia.

2. The Qi-tonifying and Blood-nourishing Traditional Chinese Medicine composition according to claim 1, characterized in that, It is made from the following components by weight: 30-35 parts Polygonatum sibiricum, 18-22 parts Ficus hirta, 14-17 parts Sargassum fusiforme, 14-17 parts Codonopsis pilosula, 9-11 parts Rubus idaeus, and 6-9 parts Cinnamomum cassia.

3. The traditional Chinese medicine composition for replenishing qi and nourishing blood according to claim 1, characterized in that, It is made from the following components in parts by weight: 32 parts Polygonatum sibiricum, 20 parts Ficus hirta, 15 parts Sargassum fusiforme, 15 parts Codonopsis pilosula, 10 parts Rubus idaeus, and 8 parts Cinnamomum cassia.

4. The traditional Chinese medicine composition for replenishing qi and nourishing blood according to claim 1, characterized in that, The ratio of the total mass of Codonopsis pilosula and Raspberry to the mass of Prunus armeniaca is (1~1.6):

1.

5. The traditional Chinese medicine composition for replenishing qi and nourishing blood according to claim 1, characterized in that, The ratio of the sum of the masses of Sargassum fusiforme and Cinnamomum cassia to the mass of Polygonatum sibiricum is 1:(1~1.8).

6. The method for preparing the Qi-tonifying and blood-nourishing traditional Chinese medicine composition according to any one of claims 1 to 5, characterized in that, Includes the following steps: (1) Powder the five-finger peach, codonopsis and raspberry and mix them evenly to obtain the first mixture; extract the first mixture by percolation with ethanol solution, concentrate under reduced pressure to obtain percolate; (2) After crushing Polygonatum, Sargassum fusiforme and Cinnamomum cassia, mix them evenly to obtain a second mixture; add the second mixture, cellulase and β-glucanase to water, and hydrolyze to obtain an enzymatic hydrolysate; inoculate Lactobacillus plantarum into the enzymatic hydrolysate, ferment, sterilize, and obtain a fermentation broth; (3) Mix the obtained percolate and fermentation liquid evenly, filter, and obtain the Qi-tonifying and blood-nourishing Chinese medicine composition.

7. The method for preparing the Qi-tonifying and blood-nourishing traditional Chinese medicine composition according to claim 6, characterized in that, The mass ratio of the first mixture to the ethanol solution is 1:(4~10); and / or The ethanol solution has a mass concentration of 50-70%.

8. The method for preparing the Qi-tonifying and blood-nourishing traditional Chinese medicine composition according to claim 6, characterized in that, The mass ratio of the second mixture, cellulase, β-glucanase, and water is 1:(0.005~0.03):(0.005~0.02):(4~10).

9. The method for preparing the Qi-tonifying and blood-nourishing traditional Chinese medicine composition according to claim 6, characterized in that, The inoculation amount of *Lactobacillus plantarum* is 1-4 wt%.

10. The method for preparing the Qi-tonifying and blood-nourishing traditional Chinese medicine composition according to claim 6, characterized in that, Satisfy at least one of the following (a) to (c): (a) The temperature of the percolation extraction is 40~50℃; (b) The enzymatic hydrolysis temperature is 45~55℃, and the enzymatic hydrolysis time is 3~6h; (c) The fermentation time is 32~60h and the fermentation temperature is 35~40℃.

11. The use of the qi-tonifying and blood-nourishing traditional Chinese medicine composition according to any one of claims 1 to 5 in the preparation of qi-tonifying and blood-nourishing medicines.

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