Blood replenishing composition for promoting utilization of iron agent

Abstract

The invention discloses a blood-enriching composition for promoting utilization of an iron agent, which belongs to the technical field of health-care food, and is prepared from the following raw materials in parts by weight: 0.5-3 parts of black ginseng, 9-15 parts of astragalus membranaceus, 0.2-1 part of donkey-hide gelatin, 6-12 parts of hawthorn, 4-9 parts of jujube, 0.5-3 parts of double-petal red rose and a nutrient supplement. The nutrition enhancer at least comprises 0.05-0.5 part of an iron agent. According to the blood replenishing composition for promoting utilization of the iron agent provided by the invention, the black ginseng not only can alleviate the warm property of the astragalus membranaceus and enhance the qi tonifying ability of the astragalus membranaceus, but also can cooperate with the colla corii asini and the Chinese dates to nourish blood to carry qi, so that the situation that blood is not replenished due to deficiency of blood caused by independent blood replenishing is avoided. The black ginseng, the hawthorn and the double-petal red rose can promote blood circulation to remove blood stasis, promote transportation and transformation of the spleen and the stomach, prevent the donkey-hide gelatin and the Chinese dates from being greasy and obstructing the stomach, and are suitable for people with deficiency of qi and blood such as pale complexion, dizziness, weakness, palpitation, shortness of breath and inappetence caused by deficiency of qi and blood.

Description

Technical Field

[0001] This invention relates to a blood-enriching composition that promotes iron utilization, belonging to the field of health food technology. Background Technology

[0002] Iron is an essential trace mineral element for the human body. It participates in the formation of hemoglobin, myoglobin, and various enzymes, playing a crucial role in physiological processes such as oxygen transport and energy metabolism. Iron metabolic balance depends on the coordinated regulation of multiple links, including absorption, transport, and storage. Among these, serum ferritin (SF) and transferrin (TRF) in the blood are core indicators reflecting the state of iron metabolism, and changes in their concentrations can help diagnose iron deficiency or excess.

[0003] Iron deficiency anemia (IDA) is caused by an imbalance between the body's iron demand and supply, leading to the depletion of stored iron (ID), followed by iron deficiency in red blood cells (IDE), and ultimately resulting in iron deficiency anemia (IDA). Unlike iron deficiency anemia, iron utilization disorder anemia (IDAU) is not simply caused by insufficient iron intake, but rather by a situation where the body's iron stores are normal or elevated, but the iron cannot be effectively utilized. For example, impaired iron release (such as ferritin and hemosiderin) prevents the normal release of stored iron into the bloodstream; or abnormal iron transport prevents iron released from storage from being transported to the bone marrow via transferrin to participate in hemoglobin synthesis, also leading to insufficient raw materials for red blood cell production and causing anemia.

[0004] Traditional Chinese medicine (TCM) categorizes anemia under the terms "blood deficiency," "chlorosis," and "asthenia," with the core pathogenesis being spleen and stomach weakness, insufficient or excessive consumption of qi and blood leading to decreased organ function and malnourishment of the whole body. TCM believes that qi and blood are interdependent, with "blood being the mother of qi, and qi being the commander of blood." Blood deficiency is often accompanied by qi deficiency, forming a complex syndrome of both qi and blood deficiency. The spleen and stomach are the "source of qi and blood production." Long-term dietary irregularities (such as picky eating, overeating, or excessive consumption of cold foods) or spleen and stomach weakness lead to abnormal transformation and transportation of nutrients, resulting in insufficient qi and blood production. Treatment often focuses on strengthening the spleen and replenishing qi, emphasizing "supplementing deficiencies and regulating qi flow." Currently, most traditional Chinese medicine compositions for treating anemia are based on traditional theories such as invigorating qi and nourishing blood, tonifying the kidneys and strengthening the spleen, and nourishing yin and blood. Although some can improve symptoms such as sallow complexion and fatigue, they cannot effectively regulate iron metabolism or promote red blood cell production, or contain special ingredients that can easily cause adverse reactions. For example, ferrous sulfate can easily cause gastrointestinal side effects such as nausea, vomiting, and constipation; long-term use of tonifying herbs such as Polygonum multiflorum and Rehmannia glutinosa can increase the burden on the kidneys. Summary of the Invention

[0005] In order to solve the problems existing in the prior art, the present invention provides a blood-tonifying composition that promotes the utilization of iron, and achieves synergistic effect through the combination of traditional Chinese and Western medicine. It is suitable for people with insufficient qi and blood, such as pale complexion, dizziness, fatigue, palpitations, shortness of breath, and loss of appetite.

[0006] The present invention achieves the above objectives by adopting the following technical solutions:

[0007] This invention provides a blood-tonifying composition that promotes iron utilization, comprising the following raw materials in parts by weight: 0.5-3 parts black ginseng, 9-15 parts astragalus, 0.2-1 part donkey-hide gelatin, 6-12 parts hawthorn, 4-9 parts jujube, 0.5-3 parts double-petaled red rose, and a nutritional fortifier;

[0008] The nutrient fortifier includes at least 0.05 to 0.5 parts of iron, which is an iron compound specified in the "Standard for the Use of Food Nutrient Fortifiers" (GB14880).

[0009] Specifically, the iron agent is selected from any one or more of ferric chloride, heme iron, ferrous glycinate, ferrous gluconate, ferrous fumarate, ferrous sulfate, and sodium ferric ethylenediaminetetraacetate.

[0010] In a preferred embodiment, the hematopoietic composition for promoting iron utilization provided by the invention is made from the following raw materials in parts by weight: 0.5 parts black ginseng, 9 parts astragalus, 0.5 parts donkey-hide gelatin, 6 parts hawthorn, 4.5 parts jujube, and 1 part double-petaled red rose.

[0011] Furthermore, the nutritional fortifier also includes 0.02–0.1 parts of vitamin C and 5 × 10⁻⁶ parts of folic acid. -5 ~1.5×10 -4 One serving, vitamin B12 is 1×10 -6 ~4×10 -6 Any one or more of the following.

[0012] Furthermore, the hematopoietic composition for promoting iron utilization provided by the invention also includes 1 to 5 parts of a flavoring agent, wherein the flavoring agent is selected from any one or more of sucrose, allulose, xylitol, fructooligosaccharides, sorbitol, and isomaltooligosaccharides.

[0013] Specifically, the dosage form of the hematopoietic composition that promotes iron utilization is an oral preparation, which is selected from any one of granules, tablets, capsules, oral liquids or pills.

[0014] Preferably, the black ginseng, astragalus, jujube, hawthorn, and double-petaled red rose are processed into a concentrated traditional Chinese medicine product through a water extraction process.

[0015] Furthermore, the water extraction process of the concentrated traditional Chinese medicine includes the following steps:

[0016] S1. Take black ginseng, astragalus, jujube, hawthorn and double-petaled red rose and put them into the multi-functional extraction tank in sequence. Add 8 to 12 times the amount of drinking water and decoct for 1 to 2 hours. Filter.

[0017] S2. Add 6 to 10 times the amount of drinking water, boil for 1 to 2 hours, filter, and combine the two filtrates.

[0018] S3. Concentrate the combined filtrate to prepare a traditional Chinese medicine concentrate. The relative density of the traditional Chinese medicine concentrate was measured to be 1.1 to 1.3 at 60℃.

[0019] In one specific embodiment, the method for preparing granules includes the following steps:

[0020] The concentrated Chinese medicine, ground donkey-hide gelatin powder, flavoring agent, nutritional fortifier, and filler are granulated into granules using a one-step granulation method.

[0021] Alternatively, the preparation method of granules includes the following steps: spray drying or vacuum drying of the concentrated Chinese medicine, mixing it with ground donkey-hide gelatin powder, flavoring agent, nutritional fortifier and filler, and then granulating it by wet granulation or dry granulation to make granules.

[0022] In another specific embodiment, the method for preparing the oral liquid includes the following steps:

[0023] After filtering the concentrated Chinese medicine, it is combined with melted donkey-hide gelatin, stirred evenly with nutritional fortifiers and thickeners, then flavoring agents are added, water is added to make up to a final volume, and an oral liquid is prepared.

[0024] Description of the medicinal materials used in this invention application:

[0025] Black ginseng is a black or dark brown ginseng product made from ginseng (Panax ginseng CAMey.) through washing, repeated steaming, and drying. Black ginseng possesses the effects of replenishing qi and blood, nourishing yin and moistening dryness, invigorating qi and nourishing yin, promoting blood circulation and removing blood stasis, and tonifying the kidneys and replenishing essence. It improves qi and blood deficiency by targeting multiple points, including nourishing qi and blood, enhancing immunity, promoting blood circulation, and synergistically strengthening the spleen and kidneys. Furthermore, the polysaccharide components in black ginseng can enhance the body's absorption and utilization of iron.

[0026] Donkey-hide gelatin (Ejiao) is a solid gelatin made from the dried or fresh skin of the donkey (Equus asinus L.) through boiling and concentration. It is an essential medicine for nourishing blood and yin, moistening dryness, and stopping bleeding; it also promotes the absorption and utilization of iron.

[0027] Astragalus is the dried root of *Astragalus membranaceus* (Fisch.) Bge. var. *mongholicus* (Bge.) Hsiao, a legume. Astragalus has the functions of invigorating qi and strengthening the exterior, promoting diuresis and reducing swelling. It can enhance the spleen and stomach's digestive function to promote qi and blood circulation, raise yang qi to consolidate essence, and improve the bone marrow hematopoietic environment to promote erythrocyte production.

[0028] Hawthorn is the dried, ripe fruit of *Crataegus pinnatifida* Bge. var. major NEBr. or *Crataegus pinnatifida* Bge., both belonging to the Rosaceae family. Hawthorn aids digestion, strengthens the stomach, promotes qi circulation, dispels blood stasis, and can invigorate blood, remove blood stasis, and lower lipids.

[0029] Jujube is the dried, ripe fruit of the jujube plant (Ziziphus jujuba Mill.), belonging to the Rhamnaceae family. Jujube nourishes the spleen and stomach, replenishes qi and blood, and calms the mind. It can enhance the function of the spleen and stomach to promote blood circulation, and can also moderate the effects of other medicinal materials, protecting the spleen, stomach, and liver.

[0030] Double-petaled red roses are made from the dehydrated and dried buds of the double-petaled red rose, *Rose rugosa* cv. Plena. Double-petaled red roses are believed to soothe the liver, relieve depression, promote blood circulation, and regulate menstruation, thus alleviating blood deficiency caused by stagnation of qi and blood.

[0031] The beneficial effects of the present invention include, but are not limited to:

[0032] The hematopoietic composition for promoting iron utilization provided by this invention uses black ginseng to both moderate the warming properties of astragalus and enhance its qi-tonifying effects, acting as a synergist. It also works synergistically with donkey-hide gelatin and jujube to nourish blood and carry qi, acting as a harmonizing agent. Since qi flows, blood flows, avoiding the blood deficiency that can result from supplementing blood alone. Furthermore, the ginsenosides and astragalus polysaccharides in black ginseng synergistically enhance immunity, thereby improving the body's hematopoietic function. The mucilage in black ginseng can protect the gastrointestinal mucosa and reduce the stimulation of donkey-hide gelatin on the spleen and stomach. The polysaccharides and amino acids contained in black ginseng can synergistically provide hematopoietic raw materials with donkey-hide gelatin. In addition, vitamin C, vitamin B12, folic acid, and iron are added to the formula as hematopoietic raw materials, promoting the production of hemoglobin and red blood cells.

[0033] Black ginseng, hawthorn, and double-petaled red rose can invigorate blood circulation, promote spleen and stomach function, prevent the greasy taste of donkey-hide gelatin and jujube from hindering the stomach, promote the absorption and utilization of vitamins and iron, and improve the absorption and utilization rate of nutrients, thus achieving the effect of nourishing without stagnation and promoting circulation without harm.

[0034] The blood-tonifying composition that promotes iron utilization provided by this invention combines traditional Chinese and Western medicine for synergistic effects, and is suitable for people with insufficient qi and blood, such as pale complexion, dizziness, fatigue, palpitations, shortness of breath, and loss of appetite. Attached Figure Description

[0035] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this invention, illustrate exemplary embodiments of the invention and are used to explain the invention, but do not constitute an undue limitation of the invention. In the drawings:

[0036] Figure 1 The changes in body weight of rats in each group;

[0037] Figure 2 The changes in RBC levels in each group of rats;

[0038] Figure 3 The changes in Hb levels in each group of rats;

[0039] Figure 4 The changes in SF levels in rats of each group are shown. Detailed Implementation

[0040] The present invention will be further described in detail below. However, it should be noted that the following specific embodiments are merely exemplary examples of the invention, and the scope of protection of the invention is not limited thereto. The scope of protection of the invention is defined only by the claims. It will be apparent to those skilled in the art that various other modifications and substitutions can be made to the embodiments of the invention within the scope of protection defined by the claims, and the same technical effects can still be achieved, thus achieving the ultimate technical objective of the invention.

[0041] The sources of raw materials used in the following examples are explained below:

[0042] Black ginseng: Jilin Juxiang Biotechnology Co., Ltd., produced in Tonghua City, Jilin Province;

[0043] Astragalus: Inner Mongolia Tianheng Pharmaceutical Co., Ltd., produced in Ming'an Town, Urad Front Banner, Bayannur City, Inner Mongolia Autonomous Region;

[0044] Donkey-hide gelatin: Shandong Hongjitang Pharmaceutical Co., Ltd.;

[0045] Hawthorn: Qingzhou Hanfeng Chinese Herbal Medicine Co., Ltd., produced in Wangfen Town, Qingzhou City, Weifang, Shandong Province;

[0046] Jujubes: Hebei Yiren Pharmaceutical Co., Ltd., produced in Xinjiang Uygur Autonomous Region;

[0047] Double-petaled red rose: Produced by Shandong Fanglei Rose Technology Development Co., Ltd., located in Pingyin County, Jinan City.

[0048] Example 1:

[0049] The hematopoietic composition for promoting iron utilization provided in Example 1 is made from the following raw materials by weight: 0.5 kg of black ginseng, 9 kg of astragalus, 0.5 kg of donkey-hide gelatin, 4.5 kg of jujube, 6 kg of hawthorn, and 1 kg of double-petaled red rose.

[0050] Nutritional fortifiers: 0.25 kg of ferric chloride heme; 0.05 kg of vitamin C, 0.1 g of folic acid, and 1.32 mg of vitamin B12;

[0051] Flavoring agent: 5 kg of sucrose;

[0052] Filler: 5 kg of maltodextrin.

[0053] The blood-replenishing composition provided in Example 1 is in granule form, and the specific preparation method includes the following steps:

[0054] S1. Take black ginseng, astragalus, jujube, hawthorn and double-petaled red rose and put them into the multi-functional extraction tank in sequence. Add 8 times the amount of drinking water and decoct for 2 hours. Filter to obtain the first filtrate and the first residue.

[0055] S2. Add 6 times the amount of drinking water to the primary filter residue, boil for 2 hours, filter, and obtain secondary filtrate and secondary filter residue. Combine the primary filtrate and secondary filtrate.

[0056] S3. The combined filtrate is concentrated in a single-effect concentrator to a Chinese herbal medicine concentrate with a relative density of 1.12 to 1.14 (measured at 60°C);

[0057] S410. The nutrient fortifier and filler are mixed using an equal-incremental method. The specific steps are as follows:

[0058] The raw materials that make up the nutrient fortifier are mixed to obtain a premixed powder ①;

[0059] Take an equal amount of filler to premixed powder ① and mix it with premixed powder ① for about 1 minute. Pass it through a 40-mesh sieve to obtain premixed powder ②.

[0060] Take an equal amount of filler to premixed powder ② and mix it with premixed powder ② for about 1 minute. Pass it through a 40-mesh sieve to obtain premixed powder ③.

[0061] S420. Add powdered donkey-hide gelatin powder (80 mesh), flavoring agent (80 mesh), remaining filler (80 mesh), and premixed powder ③ to a one-step granulator. The powder is suspended and flowed by hot air, and the concentrated Chinese medicine is slowly sprayed into the granulator to make about 20 kg of granules.

[0062] The adult daily dosage of the prepared granules is 20g.

[0063] Example 2:

[0064] The hematopoietic composition for promoting iron utilization provided in Example 2 is made from the following raw materials by weight: 0.5 kg of black ginseng, 9 kg of astragalus, 0.5 kg of donkey-hide gelatin, 6 kg of hawthorn, 4.5 kg of jujube, and 1 kg of double-petaled red rose;

[0065] Nutritional fortifiers: 0.25 kg of ferric chloride heme; 0.05 kg of vitamin C, 0.1 g of folic acid, and 1.32 mg of vitamin B12;

[0066] Flavoring agent: 1 kg of allulose.

[0067] Thickener: Sodium carboxymethyl cellulose (CMC-Na).

[0068] The blood-replenishing composition provided in Example 2 is in the form of an oral liquid, and the specific preparation method includes the following steps:

[0069] S1. Take black ginseng, astragalus, jujube, hawthorn and double-petaled red rose and put them into the multi-functional extraction tank in sequence. Add 8 times the amount of drinking water and decoct for 2 hours. Filter to obtain the first filtrate and the first residue.

[0070] S2. Add 6 times the amount of drinking water to the primary filter residue, boil for 2 hours, filter, and obtain secondary filtrate and secondary filter residue. Combine the primary filtrate and secondary filtrate.

[0071] S3. Concentrate the combined filtrate in a single-effect concentrator to a concentration with a relative density of 1.20 (measured at 60℃), and then filter.

[0072] S410. Melt the donkey-hide gelatin, combine it with the filtered concentrated liquid, and add it to the mixing tank and stir to mix.

[0073] S420. Dissolve the nutrient fortifier and CMC-Na in water beforehand, and then add them to the mixing tank;

[0074] S430. Add allulose to the mixing tank, add water to make up to 20L, continue stirring and mixing for 30-40 minutes, fill into the container, sterilize at 100-105℃ for 30 minutes to make an oral liquid.

[0075] The process involves melting donkey-hide gelatin at a relatively high temperature, then mixing it with the concentrated liquid while it's still hot to ensure even mixing. After mixing, the material temperature decreases, at which point a nutrient fortifier is added to prevent the high temperature from damaging ingredients such as vitamin C. Finally, allulose is added to prevent the high temperature from affecting the stability of the flavoring agent.

[0076] The daily dosage of the prepared oral liquid for adults is 20 mL.

[0077] Example 3:

[0078] The anemia-enhancing composition for promoting iron utilization provided in Example 3 is made from the following raw materials by weight:

[0079] Black ginseng 0.5kg, astragalus 15kg, donkey-hide gelatin 1kg, hawthorn 6kg, jujube 9kg, double-petaled red rose 3kg;

[0080] Nutritional fortifiers: Heme iron 0.05 kg, ferrous sulfate 0.1 kg; Vitamin C 0.02 kg, folic acid 0.15 kg, Vitamin B12 1 mg;

[0081] Flavoring agents: 2 kg of fructooligosaccharides, 1 kg of xylitol;

[0082] Filler: 3 kg of maltodextrin.

[0083] The blood-replenishing composition provided in Example 3 is in granule form, and the preparation method differs from that in Example 1 in that:

[0084] S410. Spray dry or vacuum dry the concentrated Chinese medicine at 60-80℃;

[0085] S420. Mix the nutrient fortifier and a portion of the filler evenly using an equal-incremental mixing method:

[0086] S430. Mix the dried powder obtained in step S410 with the ground donkey-hide gelatin powder (80 mesh), flavoring agent, and remaining filler evenly, and then granulate by wet or dry method to make 20kg granules.

[0087] Example 4:

[0088] The anemia-enhancing composition for promoting iron utilization provided in Example 4 is made from the following raw materials by weight:

[0089] Black ginseng 3kg, astragalus 9kg, donkey-hide gelatin 0.2kg, hawthorn 12kg, jujube 9kg, double-petaled red rose 3kg;

[0090] Nutritional fortifiers: ferrous glycine 0.15kg; vitamin C 0.1kg; folic acid 0.05kg; vitamin B12 4mg.

[0091] Flavoring agent: xylitol 4kg;

[0092] Thickener: Sodium carboxymethyl cellulose (CMC-Na) 0.1 kg.

[0093] The blood-replenishing composition provided in Example 4 is in the form of an oral liquid, and the specific preparation method is the same as in Example 2.

[0094] To verify the efficacy of the blood-replenishing composition provided by this invention, the applicant conducted the following animal experiments.

[0095] 1.1 Experimental materials

[0096] Cyclophosphamide for injection (batch number: 20231015, Jiangsu Hengrui Medicine Co., Ltd.); LPS (batch number: L2880, Sigma Company, USA), red blood cell (RBC) counting ELISA kit (batch number: 241005); hemoglobin (HGB) ELISA kit (batch number: 241005), serum ferritin (SF) ELISA kit (batch number: 241201); rat transferrin (TRF) ELISA detection kit (batch number: 240120); hemin (batch number: 241025, Fe content 8%); URIT-2900 automatic blood cell analyzer (Youlit Medical Electronics Co., Ltd.); Epoch microplate reader (Biotek Company, USA).

[0097] Test animals: 100 SPF-grade male SD rats, body weight: 150 g ± 10 g, purchased from the Institute of Biology, Shandong Academy of Sciences, with the license number SCXK (Lu) 2022 0006.

[0098] 1.2 Sample preparation:

[0099] Prescription of Sample 1: 0.5 kg of Angelica sinensis, 9 kg of Astragalus membranaceus, 0.5 kg of Colla Corii Asini, 4.5 kg of Chinese dates, 6 kg of Hawthorn, 1 kg of Rosa rugosa cv. Plena;

[0100] Nutritional fortifier: 0.25 kg of hemin, 0.05 kg of vitamin C, 0.1 g of folic acid, 1 mg of vitamin B12.

[0101] Flavoring agent: 3.3 kg of sucrose.

[0102] Diluent: 6.7 kg of maltodextrin.

[0103] Prescription of Sample 2: 0.5 parts of black ginseng, 9 parts of Astragalus membranaceus, 0.5 parts of Colla Corii Asini, 6 parts of Hawthorn, 4.5 parts of Chinese dates, 1 part of Rosa rugosa cv. Plena; The prescription of Sample 2 uses the raw materials described in the present invention.

[0104] Nutritional fortifier: 0.25 kg of hemin, 0.05 kg of vitamin C, 0.1 g of folic acid, 1 mg of vitamin B12.

[0105] Flavoring agent: 3.3 kg of sucrose.

[0106] Diluent: 6.7 kg of maltodextrin.

[0107] The raw materials of the above two prescriptions are made into Sample 1 and Sample 2 according to the following method:

[0108] Black ginseng (or angelica), astragalus, jujube, hawthorn, and double-petaled red rose were separately added to a multi-functional extraction tank, decocted for 2 hours with 8 times the amount of drinking water, and filtered. Then, 6 times the amount of drinking water was added, decocted for 2 hours, and filtered again. The two filtrates were combined. The combined filtrate was concentrated in a single-effect concentrator to a thick paste with a relative density of 1.12-1.14 (measured at 60℃). The nutrient fortifier and some filler were mixed in equal increments to make a premixed powder. The thick paste, donkey-hide gelatin powder (80 mesh), flavoring agent, and the remaining filler and premixed powder were mixed and granulated in one step to make granules of Sample 1 and Sample 2.

[0109] 1.3 Iron deficiency anemia in rats with qi and blood deficiency

[0110] 1.3.1 Establishment of animal models

[0111] Rats were acclimatized before the formal experiment, with a 12-hour light / dark cycle and a relative humidity of 20–25°C and 45–60%. They were allowed free access to food and water, and were housed in stainless steel cages to reduce their intake of other iron sources.

[0112] After 7 days of acclimatization, 60 rats were divided into two groups: a control group (n=10) and a model group (n=50). The control group was fed a normal diet (iron content 45 mg / kg). -1 The model group was fed a low-iron diet (iron content 10 mg / kg). -1 From day 4 to day 7, rats were injected intraperitoneally with cyclophosphamide at a dose of 40 mg / kg daily. On day 8, the rats' body weight and mental state were observed, and blood was collected from the tail vein to detect various biochemical indicators. If the rats began to show symptoms of qi and blood deficiency, such as lethargy, piloerection, reduced appetite, weight loss, and a pale and dull tail, and if there was a significant decrease in hemoglobin, red blood cell count, and serum ferritin levels, it indicated that the model was successfully established.

[0113] 1.3.2 Grouping and Dosing

[0114] Rats that successfully established the model were divided into four groups according to their body weight and biochemical indicators, with 10 rats in each group: model group, control group, sample group 1, and sample group 2 (sample group of this invention).

[0115] On the 8th day after modeling, the control group was given 22.5 mg / kg of ferric chloride heme suspension (8% iron content) by gavage. -1 Sample 1 and Sample 2 were each given 1.8 g·kg -1 Samples 1 and 2, administered in volumes of 10 mL / kg -1 The blank control group and the model group were given the same amount of deionized water, once a day for 28 consecutive days.

[0116] The control group was given a normal diet, while the other groups continued to be given a low-iron diet. The rats were weighed on days 7, 14, 21, and 28 after administration, and blood was collected from the tail vein on days 14 and 28 to detect various biochemical indicators.

[0117] 1.3.3 Sample Collection

[0118] Rub the rat's tail with your hands or warm it with warm water (45-50℃) to make it fully congested with blood. Then, cut off about 5mm from the tip of the tail with scissors. Gently squeeze from the base of the tail towards the tip to collect blood. After collecting the blood, apply pressure to the wound with a dry cotton ball to stop the bleeding. Perform various biochemical tests on the collected blood, including red blood cell (RBC), hemoglobin (Hb), serum ferritin (SF), and transferrin (TRF).

[0119] 1.3.4 Experimental Results

[0120] On the 8th day after modeling, rats in each group began to show symptoms of qi and blood deficiency, such as lethargy, hair tufting, reduced appetite, weight loss, and pale and dull tail color. The weight and biochemical indicators of rats in each group were measured, and the results are shown in Table 1.

[0121] Table 1. Body weight and biochemical indicators of rats in each group ( n=10)

[0122] Group Body weight (g) <![CDATA[RBC(×10 12 / L)]]> Hb(g / L) SF (ng / mL) Blank group 204.6±6.4 6.23±0.59 165.13±10.2 97.2±4.7 Model group 190.1±8.7* 3.70±0.38** 82.12±7.23** 42.9±6.1** control group 188.2±6.9* 3.73±0.31** 84.36±9.79** 40.2±6.9** Sample 1 group 191.4±7.7* 3.69±0.42** 80.91±8.33** 43.1±4.4** 2 groups of samples 189.8±9.1* 3.72±0.26** 81.15±8.25** 41.4±7.2**

[0123] * indicates a statistically significant difference compared to the control group (P < 0.05), and ** indicates a highly statistically significant difference compared to the control group (P < 0.01).

[0124] Analysis of the data in Table 1 shows that, compared with the blank group, the levels of RBC, Hb, and SF in each group were significantly reduced (P<0.01), while the level of TRF was significantly increased (P<0.01), indicating that the rats showed obvious symptoms of iron deficiency anemia after modeling. Combined with the above symptoms of qi and blood deficiency, it indicates that the rat model of iron deficiency anemia with qi and blood deficiency was successfully established.

[0125] Figure 1 The changes in body weight of rats in each group are shown. Figure 1 It was found that, compared with the blank group, the rats in the model group showed slow weight gain (P < 0.05 or P < 0.01). Compared with the model group, there was no significant difference in weight among the control group (iron gavage) rats (P > 0.05). After modeling, the weight gain of rats after gavage supplementation with iron was not significant, and even after 28 days of gavage, they still exhibited lethargy, reduced appetite, and slightly pale tails. In sample group 2 (the sample group of this invention), after 21 days of gavage, the rats' water and food intake increased significantly, their activity level increased, their tails became redder, and their weight gain was significant (P < 0.01).

[0126] Figure 2 and Figure 3The changes in RBC and Hb levels in each group of rats are shown. Figure 2 and Figure 3 It is evident that, compared to the model group, iron supplementation alone in the control group had a slow onset of improvement in erythrocyte (RBC) and hemoglobin (Hb) levels in rats with iron deficiency anemia due to qi and blood deficiency. There was no significant difference after 14 days of gavage (P > 0.05), and a slight improvement was observed after 28 days. In contrast, the RBC and Hb levels in sample group 2 (the sample group of this invention) were significantly improved after 14 days of gavage (P < 0.01). This indicates that the sample of this invention has a significant effect on improving RBC and Hb levels in rats with iron deficiency anemia due to qi and blood deficiency, with a rapid onset of action and significant short-term blood-replenishing effect.

[0127] Figure 4 The changes in SF levels in each group of rats are shown. Figure 4 As can be seen, compared with the model group, the serum ferritin level of sample group 2 (the sample group of this invention) was significantly increased after 14 days of gavage (P<0.01), and was significantly higher than that of the control group and sample group 1. This indicates that the sample of this invention can supplement and promote the absorption of iron, effectively and rapidly improve the SF level of rats with iron deficiency anemia of qi and blood deficiency type, improve iron reserves, and the improvement effect is better with the extension of administration time.

[0128] The above studies indicate that while iron supplementation with ferric chloride alone can avoid gastrointestinal discomfort caused by inorganic iron such as ferrous sulfate (Fe2SO4·7H2O), reduce gastric mucosal irritation, and increase iron absorption, its effect is slow. The sample of this invention combines raw materials such as black ginseng with iron supplements and vitamins for a synergistic effect, increasing iron absorption while rapidly raising blood sugar levels, leading to a rapid improvement in anemia symptoms in a short period. In sample group 1, replacing black ginseng with angelica root resulted in a slower increase in Hb and RBC counts, significantly reducing the blood-replenishing efficiency. This suggests that black ginseng plays a crucial coordinating role in the prescription, harmonizing the various herbs and enhancing their synergistic effects, making it an indispensable ingredient.

[0129] 1.4 Inflammatory Iron Utilization Disorder Anemia in Rats

[0130] 1.4.1 Establishment of animal models

[0131] Forty SD rats were acclimatized for one week and then injected intraperitoneally with LPS (0.5 mg / kg) daily, while being fed a high-iron diet (containing 70 mg / kg iron). -1 The model was established over a period of 4 weeks. Blood samples were collected from the tail vein at weeks 2 and 4 according to step "1.3.3" to measure the levels of red blood cells (RBC), hemoglobin (Hb), serum ferritin (SF), and transferrin (TRF). Rats in the model group exhibited poor mental state, significantly reduced food and water intake and body weight, pale limbs and tail, and significantly abnormal blood biochemical indicators, indicating successful model establishment.

[0132] 1.4.2 Grouping and Dosing

[0133] After 7 days of acclimatization, SD rats were randomly divided into a blank control group, a model group, and a sample group (gavage dose 1.8 g·kg⁻¹). -1 ), Sample 2 groups (sample group of this invention, gavage dose 1.8 g·kg) -1 Except for the control group, all other groups were modeled according to the method in "1.4.1". At the same time as modeling, each group was administered the prescribed dose by gavage.

[0134] 1.4.3 Experimental Results

[0135] Table 2. Changes in RBC and Hb levels in rats of each group.

[0136]

[0137] * indicates P < 0.05 compared to the control group; ** indicates P < 0.01 compared to the control group.

[0138] The results in Table 2 show that, compared with the control group, the levels of RBC and Hb in the model group rats decreased to a certain extent after 2 weeks of high-iron diet and LPS induction (P<0.01), and continued to decrease after 4 weeks of modeling (P<0.01). The rats in the model group showed symptoms of anemia, indicating that the modeling was successful.

[0139] During the modeling process, samples 1 and 2 (samples of this invention) were administered via gavage. After 2 weeks, the RBC and Hb levels showed relatively small fluctuations. After 4 weeks, the RBC and Hb levels in sample 1 group decreased slightly, while the Hb level in the sample group of this invention did not change significantly. This indicates that a high-iron diet and LPS induction can significantly reduce the RBC and Hb levels in rats. The sample of this invention can alleviate the damage caused by the modeling drugs to the rats, regulate the hematopoietic function, and maintain stable RBC and Hb levels.

[0140] Table 3. Changes in SF and TRF levels in rats of each group.

[0141]

[0142] * indicates P < 0.05 compared to the control group; ** indicates P < 0.01 compared to the control group.

[0143] The results showed that, compared with the control group, the serum SF level of rats in the model group was significantly reduced (P<0.01) and the TRF level was increased (P<0.05) after 2 weeks of high-iron diet and LPS induction. The difference continued to increase after 4 weeks (P<0.01), indicating that LPS modeling in rats led to impaired iron absorption and utilization. Even with high-iron diet intake during modeling, iron deficiency still occurred in the serum, resulting in reduced iron storage in the blood and thus causing anemia.

[0144] During simultaneous modeling and gavage administration, sample 2 (the sample of this invention) showed a slower decline in SF and a slower increase in TRF compared to the model group at 2 and 4 weeks of gavage, with no significant differences in SF and TRF compared to the control group (P > 0.05). However, during simultaneous modeling and gavage administration, sample 1 showed significant differences in SF and TRF compared to the control group at 4 weeks (P < 0.05). This indicates that the sample of this invention can significantly improve the utilization of iron by model rats, reduce the impact of LPS modeling on iron absorption and utilization, and is superior to sample 1.

[0145] The above results indicate that the sample of this invention can significantly reduce the effects of LPS modeling drugs on serum ferritin (SF) and transferrin (TRF) levels, maintain iron homeostasis in vivo, and improve abnormalities in erythrocytes and hemoglobin caused by iron metabolism disorders. However, in sample 1, after replacing black ginseng with Angelica sinensis, SF levels decreased and TRF levels increased after 4 weeks of simultaneous administration during modeling, showing a decreasing trend in iron storage. RBC and Hb levels in rats also showed a decreasing trend, indicating that replacing black ginseng with Angelica sinensis weakens the overall efficacy of the prescription. The role of black ginseng in the prescription is not simply to replenish qi and promote blood circulation; its role in coordinating the overall efficacy of the various herbs and components in the prescription is irreplaceable.

[0146] The above specific embodiments should not be construed as limiting the scope of protection of the present invention. For those skilled in the art, any alternative improvements or modifications made to the embodiments of the present invention shall fall within the scope of protection of the present invention.

[0147] Any aspects of this invention not described in detail are well-known to those skilled in the art.

Claims

1. A hematopoietic composition that promotes iron utilization, characterized in that, It is made from the following ingredients in parts by weight: 0.5-3 parts black ginseng, 9-15 parts astragalus, 0.2-1 part donkey-hide gelatin, 6-12 parts hawthorn, 4-9 parts jujube, 0.5-3 parts double-petaled red rose, and nutritional fortifier; The nutrient fortifier includes at least 0.05 to 0.5 parts of iron, which is an iron compound as specified in the "Standards for the Use of Food Nutrient Fortifiers".

2. The blood-replenishing composition according to claim 1, characterized in that, It is made from the following ingredients in parts by weight: 0.5 parts black ginseng, 9 parts astragalus, 0.5 parts donkey-hide gelatin, 6 parts hawthorn, 4.5 parts jujube, and 1 part double-petaled red rose.

3. The blood-replenishing composition according to claim 1, characterized in that, The nutritional fortifier also includes 0.02–0.1 parts of vitamin C and 5 × 10⁻⁶ parts of folic acid. -5 ~1.5×10 -4 One serving, vitamin B12 is 1×10 -6 ~4×10 -6 Any one or more of the following.

4. The blood-replenishing composition according to claim 1, characterized in that, The iron agent is selected from any one or more of ferric chloride, heme iron, ferrous glycinate, ferrous gluconate, ferrous fumarate, ferrous sulfate, and sodium ferric ethylenediaminetetraacetate.

5. The blood-replenishing composition according to claim 1, characterized in that, It also includes 1 to 5 parts of flavoring agent, wherein the flavoring agent is selected from any one or more of sucrose, allulose, xylitol, fructooligosaccharides, sorbitol, and isomaltooligosaccharides.

6. The blood-replenishing composition according to claim 1, characterized in that, The dosage form of the blood-tonifying composition is an oral preparation, which is selected from any one of granules, tablets, capsules, oral liquids or pills.

7. The blood-replenishing composition according to claim 6, characterized in that, The black ginseng, astragalus, jujube, hawthorn, and double-petaled red rose were processed into a Chinese medicine concentrate through water extraction. The relative density of the Chinese medicine concentrate was measured to be 1.1 to 1.3 at 60°C.

8. The blood-replenishing composition according to claim 7, characterized in that, The water extraction process of the concentrated traditional Chinese medicine includes the following steps: S1. Take black ginseng, astragalus, jujube, hawthorn, and double-petaled red rose and put them into an extraction tank. Add 8 to 12 times the amount of drinking water and decoct for 1 to 2 hours. Filter. S2. Add 6 to 10 times the amount of drinking water, boil for 1 to 2 hours, filter, and combine the two filtrates. S3. Concentrate the combined filtrate to produce a concentrated traditional Chinese medicine.

9. The blood-replenishing composition according to claim 8, characterized in that, The preparation method of granules includes the following steps: The concentrated Chinese medicine, ground donkey-hide gelatin powder, flavoring agent, nutritional fortifier, and filler are granulated into granules using a one-step granulation method. Alternatively, the preparation method of granules includes the following steps: spray drying or vacuum drying of the concentrated Chinese medicine, mixing it with ground donkey-hide gelatin powder, flavoring agent, nutritional fortifier and filler, and then granulating it by wet granulation or dry granulation to make granules.

10. The blood-replenishing composition according to claim 8, characterized in that, The preparation method of oral liquid includes the following steps: After filtering the concentrated Chinese medicine, it is combined with melted donkey-hide gelatin, stirred evenly with nutritional fortifiers and thickeners, then flavoring agents are added, water is added to make up to a final volume, and an oral liquid is prepared.

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