Traditional Chinese medicine composition for improving anemia caused by deficiency of qi and blood and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for improving anemia due to deficiency of qi and blood and a preparation method thereof, and relates to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition comprises the following components by weight: 18-22g of Radix Astragali, 13-17g of prepared rehmannia root, 6-10g of prepared fleece flower root, 13-17g of suberect spatholobus stem, 8-12g of mulberry, 8-12g of parched white peony root, 8-12g of wolfberry, 8-12g of glossy privet fruit, 13-17g of Chinese angelica, 10-14g of Ligusticum wallichii, and 8-12g of ginseng. The radix astragali and the ginseng are used as monarch drugs to tonify qi and enrich blood, the prepared rehmannia root, the angelica sinensis and the like are used as ministerial drugs to enhance blood replenishing, the radix polygoni multiflori preparata and the like are used as assistants to solve the root cause of deficiency of liver and kidney, and the ligusticum wallichii is used for balancing qi and blood, so that the composition has the characteristics of tonifying without stagnation and nourishing without greasiness through precise quantitative proportioning, and is suitable for various anemia people with deficiency of qi and blood; the traditional Chinese medicine composition has a remarkable effect on patients with symptoms of deficiency of liver and kidney, weakness of spleen and stomach and unsmooth qi and blood, and has both treatment and prevention effects.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for improving anemia caused by deficiency of qi and blood and a preparation method thereof. BACKGROUND

[0002] Anemia caused by deficiency of qi and blood is a common and frequently-occurring disease in clinic, which seriously affects the physical and mental health and quality of life of patients. In the theoretical system of traditional Chinese medicine, qi and blood are the basic substances for maintaining the life activities of the human body, and deficiency of qi and blood will lead to the decline of the functions of viscera and the decrease of the disease resistance, and further cause a series of uncomfortable symptoms, such as pale and colorless complexion, dizziness, fatigue, palpitation and shortness of breath, insomnia and dreaminess, etc. Long-term anemia caused by deficiency of qi and blood not only makes the patient weak, but also can further cause a significant decrease in immunity, increase the risk of infection, and even cause damage to the functions of important organs such as heart, brain and kidney, which seriously affects the daily life and work of patients.

[0003] At present, the commonly used solutions for improving anemia caused by deficiency of qi and blood in clinic mainly include western medicine iron supplements and traditional Chinese medicine prescriptions. Western medicine iron supplements can supplement iron elements and improve iron deficiency anemia to a certain extent, but they can easily cause gastrointestinal irritation symptoms such as nausea, vomiting, abdominal pain and constipation, which makes it difficult for some patients to adhere to the treatment. Moreover, western medicine iron supplements have limited treatment effect on non-iron deficiency anemia, such as anemia caused by deficiency of qi and blood, liver and kidney deficiency, etc., and cannot fundamentally solve the problem of deficiency of qi and blood. Traditional Chinese medicine prescriptions, such as Bazhen Decoction and Siwu Decoction, mostly focus on single qi or blood tonification in the aspect of qi and blood regulation, and have the problems of tonifying without transporting and nourishing without greasiness. For example, Radix Rehmanniae Preparata and Angelica sinensis have the effect of tonifying blood, but they can easily increase the burden of the spleen and stomach, leading to abnormal transportation of the spleen and stomach and symptoms such as indigestion and loss of appetite. And simple qi tonifying medicinal materials, such as Astragalus membranaceus and Panax ginseng, can easily cause symptoms of internal heat, such as dry mouth and throat, sore throat, constipation, etc. if taken for a long time and in large amounts. SUMMARY

[0004] The present application aims at solving the problems in the prior art, and provides a traditional Chinese medicine composition for improving anemia caused by deficiency of qi and blood, which is prepared from eleven medicinal materials in specific proportions, wherein the eleven medicinal materials are Huangqi, Shudihuang, Zhishouwu, Jixueteng, Sangshen, Chao Baishao, Gouqizi, Nuzhensizi, Danggui, Chuanxiong and Renshen.

[0005] The present application aims at solving the problems in the prior art, and provides a traditional Chinese medicine composition for improving anemia caused by deficiency of qi and blood, which is prepared from eleven medicinal materials in specific proportions, wherein the eleven medicinal materials are Huangqi, Shudihuang, Zhishouwu, Jixueteng, Sangshen, Chao Baishao, Gouqizi, Nuzhensizi, Danggui, Chuanxiong and Renshen.

[0006] Further, the optimal proportions of the raw medicinal materials are as follows: Huangqi 20 g, Shudihuang 15 g, Zhishouwu 8 g, Jixueteng 15 g, Sangshen 10 g, Chao Baishao 10 g, Gouqizi 10 g, Nuzhensizi 10 g, Danggui 15 g, Chuanxiong 12 g and Renshen 10 g.

[0007] The present application aims at solving the problems in the prior art, and provides a preparation method of a traditional Chinese medicine composition for improving anemia caused by deficiency of qi and blood. Pre-treatment of raw materials: Zhishouwu is mixed with yellow rice wine, and then is steamed after being closed and moistened, and is crushed after being cooled; Renshen, Huangqi and Chuanxiong are crushed respectively, and are mixed with the pre-treated Zhishouwu to obtain a mixture of fat-soluble medicinal materials; Extraction of fat-soluble components: the mixture of fat-soluble medicinal materials is put into a supercritical CO2 extraction device for extraction, and the extract is collected to obtain fat-soluble active components; Extraction of water-soluble components: Shudihuang, Danggui, Jixueteng, Sangshen, Gouqizi and Chao Baishao are washed and cut into segments, and are soaked in purified water and then decocted; the decocted liquid is filtered to obtain a first decocted liquid; the residue is added with purified water again for decoction, and the second decocted liquid is obtained by filtration; the two decocted liquids are combined, and are concentrated under reduced pressure to obtain a water-soluble concentrated liquid; Purification: the water-soluble concentrated liquid is passed through a macroporous resin column, and is eluted with water to remove impurities, and then is eluted with an ethanol solution; the ethanol eluate is collected, and the ethanol is recovered under reduced pressure to obtain a water-soluble purified liquid; Mixing and drying: add the fat-soluble active ingredients into the water-soluble purified liquid, stir until completely dissolved, and dry using a spray drying device to obtain dry extract powder.

[0008] Formulation: mix the dry extract powder with suitable fillers and binders, add purified water to prepare a soft material, and use an extrusion-spheronization machine to prepare pellet cores; coat the pellet cores with coating materials, and obtain the sustained-release pellet preparation after cooling Further, in the raw material pretreatment step, mix the prepared He Shou Wu with yellow rice wine, the amount of yellow rice wine is 15%-25% of the weight of the prepared He Shou Wu, close and soak for 2-3 hours until the yellow rice wine is completely absorbed, then steam at 100-110℃ for 2.5-3.5 hours, further convert the active ingredients in the prepared He Shou Wu through steaming to improve efficacy and reduce risk, cool and pulverize to 80-100 mesh to ensure that the ingredients are fully released during the subsequent extraction process; pulverize the ginseng, astragalus and chuanqiong to 80-100 mesh respectively, and mix with the pretreated prepared He Shou Wu to obtain a fat-soluble medicinal material mixture.

[0009] Further, in the fat-soluble ingredient extraction step, put the fat-soluble medicinal material mixture into a supercritical CO2 extraction device, set the extraction pressure to 28-32 MPa, the extraction temperature to 43-47℃, the CO2 flow rate to 20-25 L / h, and the extraction time to 1.5-2.5 hours. The supercritical CO2 extraction technology has the advantages of low-temperature extraction, no solvent residue, and the ability to preserve heat-sensitive ingredients, which can maximize the preservation of fat-soluble active ingredients such as ginsenosides, astragaloside, and chuanqiongzine. Collect the extract to obtain the fat-soluble active ingredients.

[0010] Further, in the water-soluble ingredient extraction step, wash and cut the prepared radix rehmanniae preparata, angelica sinensis, morindae, mulberry, and ziziphi into 1-2 cm long pieces to increase the contact area between the medicinal materials and the solvent and promote the dissolution of water-soluble ingredients. Add 8-10 times the weight of the total medicinal materials in purified water and soak for 1-1.5 hours. Soaking can make the medicinal material cells fully absorb water and swell, laying a foundation for subsequent decoction and extraction. After soaking, heat to boiling and maintain a state of gentle boiling for 1.2-1.8 hours. Gentle boiling can ensure the complete dissolution of active ingredients while avoiding the destruction of heat-sensitive water-soluble ingredients. Filter to obtain the first decoction liquid. Add 6-8 times the weight of the total medicinal materials in purified water to the filtered residue and repeat the decoction process for 1-1.5 hours. Filter to obtain the second decoction liquid. Twice decoction can reduce the waste of active ingredients and improve the extraction rate. Combine the two decoction liquids and concentrate them under reduced pressure (vacuum degree -0.08 to -0.09 MPa, temperature 55-65℃) to a clear paste with a relative density of 1.10-1.15 (60℃). Obtain the water-soluble concentrated liquid. Reduced pressure concentration can reduce the concentration temperature and reduce the loss of water-soluble ingredients such as polysaccharides and betaine.

[0011] Further, in the purification step, the water-soluble concentrate is cooled to room temperature, and passed through a pretreated D101 macroporous resin column at a flow rate of 2-3 BV / h, the resin amount is 1:3-1:5 of the concentrate volume. The macroporous resin has good adsorption and desorption performance, which can effectively remove starch, tannin and other impurities in the concentrate, improve the purity of the active ingredients, and then elute with 3-5 BV of purified water at a flow rate of 2-3 BV / h to remove the residual impurities and water-soluble small molecule ineffective components in the column, and then elute with 60%-80% ethanol solution at a flow rate of 1-2 BV / h, the ethanol solution can desorb the water-soluble active ingredients adsorbed by the resin, such as rehmannia glutinosa polysaccharide, medlar polysaccharide and total glycosides of white peony root, collect the ethanol eluate, and remove the ethanol by vacuum recovery (vacuum degree -0.07 to -0.08 MPa, temperature 50-60℃) to obtain a water-soluble purified liquid. The vacuum recovery can avoid ethanol residue and protect the active ingredients from being damaged.

[0012] Further, in the mixing and drying step, the fat-soluble active ingredients are added to the water-soluble purified liquid, stirred at 25-30℃ for 30-60 min until completely dissolved, to ensure uniform mixing of the two types of active ingredients and balanced drug efficacy, and then dried by spray drying equipment with an inlet temperature of 175-185℃, an outlet temperature of 75-85℃ and a feeding speed of 10-15 mL / min. The spray drying has the characteristics of fast drying speed, good product flowability and high active ingredient retention rate, and a dry extract powder with a water content of ≤5% is obtained (the dry extract powder is convenient for subsequent preparation and can prolong the shelf life of the product).

[0013] Further, in the preparation step, the dry extract powder is mixed with microcrystalline cellulose (weight ratio 1:0.3-0.5, the filler can improve the flowability and compressibility of the dry extract powder to ensure the preparation formability) and hydroxypropyl methyl cellulose (weight ratio 1:0.1-0.2, the adhesive can make the materials aggregate to form a stable soft material to provide a basis for micro-pellet preparation), and then the soft material is prepared by adding purified water, and the water addition amount is 20%-30% of the weight of the mixture. The soft material is made into a micro-pellet core with a particle size of 0.8-1.2 mm by an extrusion-spheronization machine with an extrusion speed of 300-400 r / min and a spheronization speed of 800-1000 r / min. The extrusion-spheronization technology can prepare a micro-pellet core with high roundness and uniform particle size, which provides a good carrier for subsequent coating. Ethyl cellulose is selected, and the concentration of the ethanol solution is 5%-8%. The coating material can control the drug release rate to achieve a sustained release effect. The micro-pellet core is coated by a fluidized bed coating machine (inlet temperature 40-45℃, atomization pressure 0.2-0.3 MPa, coating liquid spraying speed 5-8 mL / min) with a coating weight gain of 5%-8%. After cooling to room temperature, a sustained release micro-pellet preparation is obtained.

[0014] Compared with the prior art, the traditional Chinese medicine composition for improving anemia due to deficiency of qi and blood and the preparation method thereof have the following beneficial effects: I. The present application solves the root cause of liver and kidney deficiency by using Radix Astragali, Radix Ginseng as the monarch to tonify qi and generate blood, using Radix Rehmanniae Preparata, Angelica sinensis as the minister to enhance blood tonification, using Polygoni multiflori Radix as the assistant, and using Ligusticum chuanxiong as the guide to balance qi and blood.

[0015] II. The present application adopts segmented extraction and sustained-release preparation technology, supercritical CO2 extraction of fat-soluble components, water decoction extraction of water-soluble components, improves the retention rate of effective components, macroporous resin purification reduces impurities, reduces gastrointestinal irritation, and improves bioavailability.

[0016] Other advantages, objects, and features of the present application will be set forth in part in the following specification, and in part will become apparent to those skilled in the art from a consideration of the following specification, or can be learned from practice of the present application. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiment or prior art description. Obviously, the drawings in the following description only some embodiments of the present application, and for those skilled in the art, without creative labor, other drawings can also be obtained from these drawings.

[0018] Figure 1 Flow chart of the preparation method of the traditional Chinese medicine composition for improving anemia due to deficiency of qi and blood. DETAILED DESCRIPTION

[0019] In order to further illustrate the technical means and effects adopted by the present application to achieve the predetermined invention purpose, the following will combine the drawings and the preferred embodiments to specifically describe the specific embodiments, structures, features and effects of the present application.

[0020] Example 1 Precisely weigh each medicinal material by weight, which is Radix Astragali 20g, Radix Rehmanniae Preparata 15g, Polygoni multiflori Radix 8g, Spatholobus suberectus 15g, Morus alba 10g, Fried Paeonia lactiflora 10g, Fructus Lycii 10g, Ligustrum lucidum 10g, Angelica sinensis 15g, Ligusticum chuanxiong 12g, Radix Ginseng 10g, without mold, insect damage and other quality problems.

[0021] Take 8g of prepared rhizoma polygonati, add 1.6g of yellow rice wine (the amount is 20% of the weight of prepared rhizoma polygonati), mix well and then place in a sealed ceramic container. Let it soak for 2.5 hours at room temperature until the yellow rice wine is completely absorbed by the medicinal material. Then put the soaked prepared rhizoma polygonati into a steaming pot and steam at 105°C for 3 hours, keeping the pressure stable during the process. After steaming, take it out and cool it to room temperature naturally. Then use a universal pulverizer to grind it to 100 mesh and sieve it for use. Separately, grind 10g of ginseng, 20g of astragalus and 12g of ligusticum to 100 mesh and mix them with the prepared rhizoma polygonati powder. Put them into a three-dimensional mixer and mix at a speed of 20r / min for 15 minutes to get a uniform mixture of fat-soluble medicinal materials.

[0022] Put the mixture of fat-soluble medicinal materials into a supercritical CO2 extraction kettle. Close the kettle door and check the sealing. Then set the extraction parameters: extraction pressure 30MPa, extraction temperature 45°C, CO2 flow rate 22L / h. Start the equipment for extraction and the extraction time is 2 hours. After extraction, collect the fat-soluble extract through the separation kettle and store it in a brown glass bottle in a dark and cool place. This is the fat-soluble active ingredient.

[0023] Wash 15g of prepared rehmannia root, 15g of angelica, 15g of lonicera japonica, 10g of mulberry, 10g of medlar and 10g of fried white peony root and cut them into 1-2cm pieces with a cutting machine. Put them into a multifunctional extraction kettle and add 480g of purified water (8 times the total weight of the medicinal materials). Soak for 1.2 hours. After soaking, turn on the heating device of the extraction kettle and heat it to boiling. Keep it at a slight boiling state for 1.5 hours, stirring every 30 minutes. After boiling, filter with 100 mesh filter cloth to collect the first decoction. Add 360g of purified water (6 times the total weight of the medicinal materials) to the residue in the extraction kettle. Heat it to boiling again and decoct for 1.2 hours. Filter and collect the second decoction. Combine the two decoctions and transfer them into a vacuum concentration tank. Set the vacuum degree to -0.085MPa and the temperature to 60°C. Perform vacuum concentration until the relative density of the concentrated solution reaches 1.12 (measured at 60°C). Stop the concentration and get the water-soluble concentrated solution.

[0024] Cool the water-soluble concentrated solution to 25°C and slowly pass it through a pre-activated D101 type macroporous resin column at a flow rate of 2.5BV / h (the ratio of resin amount to concentrated solution volume is 1:4). After the concentrated solution is completely loaded onto the column, elute it with 12BV of purified water at a flow rate of 2.5BV / h. Collect the eluate during the elution process until the pH value of the eluate is stable and neutral. Then use 70% ethanol solution to elute at a flow rate of 1.5BV / h. Collect the ethanol eluate until there are no active ingredient spots detected by thin layer chromatography. Transfer the collected ethanol eluate into a vacuum recovery tank and set the vacuum degree to -0.075MPa and the temperature to 55°C. Recover the ethanol until there is no alcohol smell. Get the water-soluble purified solution.

[0025] The fat-soluble active ingredient is added into the water-soluble purified solution, and is placed in a stirring tank, and is stirred at 28°C at a rotating speed of 50 r / min for 45 min until the fat-soluble ingredient is completely dissolved; the mixed solution is sent into a spray dryer through a peristaltic pump, and the inlet air temperature is set to 180°C, the outlet air temperature is set to 80°C, and the feeding speed is set to 12 mL / min, and the equipment is started to dry; after the drying is completed, the dried powder is collected, and the moisture content is 3.2% detected by a moisture detector, which meets the requirements.

[0026] Take 100 g of the dried extract powder, add 40 g of microcrystalline cellulose (weight ratio 1:0.4) and 15 g of hydroxypropyl methyl cellulose (weight ratio 1:0.15), and place them in a mixer for 20 min; add 34.5 g of purified water (25% of the weight of the mixed material) to the mixed material, and continue to mix for 10 min to form a soft material that can be held together by hand and scattered by a light touch; place the soft material into an extrusion-spheronization machine, set the extrusion speed to 350 r / min and the spheronization speed to 900 r / min, and prepare micro-pellet cores with a particle size of about 1.0 mm; dissolve 7 g of ethyl cellulose in 93 g of ethanol to prepare a 7% ethyl cellulose ethanol solution as a coating liquid; place the micro-pellet cores into a fluidized bed coating machine, set the inlet air temperature to 42°C, the atomization pressure to 0.25 MPa, and the coating liquid spraying speed to 6 mL / min, and coat until the coating weight increases by 6%; after the coating is completed, turn off the equipment, wait for the micro-pellets to cool to room temperature, take them out, sieve, remove oversized and undersized particles, and obtain sustained-release micro-pellet preparations, which are packaged in aluminum plastic blister plates, each containing 0.3 g of micro-pellets.

[0027] Example Two According to the deficiency of blood syndrome diagnostic criteria, and blood routine examination shows that hemoglobin (Hb) ≤110 g / L of 120 cases of anemia patients, including 42 cases of male, 78 cases of female, age 20-65 years old, average age (42.3±8.5) years old; exclude patients with severe liver and kidney dysfunction, iron deficiency anemia (serum ferritin <12 μg / L), malignant tumor and allergic to the medicinal materials of the present application; 120 patients are divided into observation group and control group by random number table method, 60 cases in each group, there is no statistical significance in comparison of gender, age, disease duration, hemoglobin level and other general data of two groups of patients, which is comparable.

[0028] Experimental method: Observation group: take the sustained-release micro-pellet preparation prepared by the present application, oral administration, 2 times a day, 1 plate (containing 0.3 g of micro-pellets) each time, take with warm water, continuous administration for 4 weeks as a course of treatment.

[0029] Control group: take the commercially available Bazhen pill, oral administration, 2 times a day, 9 g each time, take with warm water, continuous administration for 4 weeks as a course of treatment.

[0030] During the experiment, the patients in both groups avoided taking other qi and blood tonifying drugs or health products, maintained regular work and rest, balanced diet, and avoided strenuous exercise.

[0031] Observation indicators and criteria: Symptom improvement: The improvement of the 5 main symptoms of pale face, dizziness, palpitation, insomnia, and limb numbness in the two groups before and after treatment was observed, and a 4-level scoring method was used: no symptoms (0 points), mild (1 point, symptoms occasionally appear and do not affect life), moderate (2 points, symptoms frequently appear and affect life), and severe (3 points, symptoms persist and severely affect life), and the symptom score improvement rate was calculated; The formula is: (pre-treatment score - post-treatment score) / pre-treatment score x 100%.

[0032] Blood routine index: Fasting venous blood was collected from the two groups before and after treatment, and the hemoglobin (Hb) and red blood cell count (RBC) levels were detected by automatic blood cell analyzer.

[0033] Marked effect: symptom score improvement rate ≥70%, Hb level returned to normal range (female ≥120g / L, male ≥130g / L) or increased by ≥20g / L compared with before treatment; Effective: 30%≤ symptom score improvement rate <70%, Hb level increased by 10-19g / L compared with before treatment; Ineffective: symptom score improvement rate <30%, Hb level increased by <10g / L compared with before treatment; Total effective rate = (number of cases with marked effect + number of cases with effect) / total number of cases x 100%.

[0034] Safety indicators: During treatment, observe whether the patients in the two groups have adverse reactions such as nausea, vomiting, abdominal distension, diarrhea, liver and kidney function abnormalities, and detect liver and kidney function before and after treatment.

[0035] Experimental results: Symptom score improvement: Before treatment, the total symptom scores of the observation group and the control group were (10.2±2.3) points and (10.5±2.1) points, respectively, with no statistically significant difference (P>0.05); after treatment, the total symptom score of the observation group was (2.1±1.2) points, with an improvement rate of (79.4±10.5)%, and the total symptom score of the control group was (4.8±1.5) points, with an improvement rate of (54.3±12.1)%, the symptom score improvement rate of the observation group was significantly higher than that of the control group (P<0.05).

[0036] Changes in blood routine index: Before treatment, the Hb and RBC levels of the two groups had no significant difference (P>0.05); after treatment, the Hb level of the observation group was (125.3±10.2) g / L, which was increased by (28.5±6.3) g / L compared with before treatment, and the RBC level was (4.5±0.4) 10 12 / L, which was increased by (0.6±0.2) 10 12 / L compared with before treatment. The Hb level of the control group was (112.1±8.5) g / L, which was increased by (15.3±5.8) g / L compared with before treatment, and the RBC level was (4.0±0.3) 10 12 / L, which was increased by (0.3±0.1) 10 12 / L compared with before treatment; the Hb and RBC improvement rates of the observation group were significantly higher than those of the control group (P<0.05).

[0037] Clinical efficacy: 42 cases in the observation group were markedly effective, 15 cases were effective, and 3 cases were ineffective, and the total effective rate was 95.0%; 27 cases in the control group were markedly effective, 16 cases were effective, and 17 cases were ineffective, and the total effective rate was 71.7%; the total effective rate of the observation group was significantly higher than that of the control group (P<0.05).

[0038] Safety: During treatment, only 2 cases in the observation group had mild abdominal distension, and the adverse reaction rate was 3.3%; 8 cases in the control group had abdominal distension and constipation, and the adverse reaction rate was 13.3%; the liver and kidney function indexes of the patients in the two groups before and after treatment were within the normal range, and no liver and kidney dysfunction occurred.

[0039]

[0040] The effect of the slow-release pellet preparation of the application on improving anemia due to deficiency of qi and blood is significantly better than that of the commercially available Bazhen pill, and in the core efficacy indicators, the symptom score improvement rate, the hemoglobin and red blood cell count improvement rates of the observation group are all significantly higher than those of the control group (P<0.05), and the total effective rate reaches 95.0%, which is higher than the 71.7% of the control group; in terms of safety, the adverse reaction rate of the observation group is only 3.3%, which is lower than the 13.3% of the control group, and no liver and kidney dysfunction occurs in the two groups; in summary, the preparation of the application has obvious advantages in efficacy and safety.

[0041] Experimental conclusion: The traditional Chinese medicine composition (slow-release pellet preparation) of the application can significantly improve the clinical symptoms of patients with anemia due to deficiency of qi and blood, improve the hemoglobin and red blood cell levels, and has better efficacy than the traditional Bazhen pill, and has less adverse reactions and high safety, and can be used as an effective drug for improving anemia due to deficiency of qi and blood.

[0042] The above merely describes the preferred embodiments of the present application, and is not intended to limit the present application in any form. Although the present application has been disclosed with the preferred embodiments as above, it is not intended to limit the present application. Any person skilled in the art can make some changes or modifications to the above disclosed technical content to obtain equivalent embodiments with equivalent changes, as long as the changes or modifications do not deviate from the technical solution of the present application. Any modification, change, equivalent change and modification of the above embodiments made according to the technical essence of the present application still belong to the scope of the technical solution of the present application.

Claims

1. A traditional Chinese medicine composition for improving anemia due to qi and blood deficiency, characterized in that, The traditional Chinese medicine composition, calculated by weight, includes: Astragalus membranaceus 18-22g, Rehmannia glutinosa 13-17g, Polygonum multiflorum 6-10g, Spatholobus suberectus 13-17g, Morus alba 8-12g, Paeonia lactiflora 8-12g, Lycium barbarum 8-12g, Ligustrum lucidum 8-12g, Angelica sinensis 13-17g, Ligusticum chuanxiong 10-14g, and Panax ginseng 8-12g.

2. The traditional Chinese medicine composition for improving anemia due to qi and blood deficiency according to claim 1, characterized in that, The optimal weight proportions of the raw medicinal materials are: Astragalus membranaceus 20g, Rehmannia glutinosa 15g, Polygonum multiflorum 8g, Spatholobus suberectus 15g, Morus alba 10g, Paeonia lactiflora 10g, Lycium barbarum 10g, Ligustrum lucidum 10g, Angelica sinensis 15g, Ligusticum chuanxiong 12g, and Panax ginseng 10g.

3. A method for preparing the traditional Chinese medicine composition as described in claims 1-2, characterized in that, The method includes: Raw material pretreatment: Mix the prepared Polygonum multiflorum with rice wine, seal and moisten it, then steam it, cool it and pulverize it. Pulverize ginseng, astragalus and chuanxiong separately, and mix them with the pretreated prepared Polygonum multiflorum to obtain a fat-soluble medicinal mixture. Extraction of fat-soluble components: The mixture of fat-soluble medicinal materials is put into a supercritical CO2 extraction device for extraction, and the extract is collected to obtain the fat-soluble active components; Extraction of water-soluble components: Wash and cut Rehmannia glutinosa, Angelica sinensis, Spatholobus suberectus, Morus alba, Lycium barbarum and stir-fried Paeonia lactiflora into sections, soak them in purified water and decoct them, filter to obtain the first decoction; add purified water to the dregs again and decoct, filter to obtain the second decoction; combine the two decoctions and concentrate under reduced pressure to a clear paste to obtain the water-soluble concentrate. Purification process: The water-soluble concentrate is passed through a macroporous resin column, eluted with water to remove impurities, and then eluted with ethanol solution. The ethanol eluent is collected, and the ethanol is recovered under reduced pressure to obtain the water-soluble purified solution. Mixed drying: The fat-soluble active ingredient is added to the water-soluble purified solution and stirred until completely dissolved. The solution is then dried using a spray drying device to obtain a dry extract powder. Formulation: The dry extract powder is mixed with suitable fillers and binders, purified water is added to make a soft material, and microcapsule cores are prepared by extrusion-spheronization machine; the microcapsule cores are coated with coating material, and the sustained-release microcapsule formulation is obtained after cooling.

4. The method for preparing a traditional Chinese medicine composition for improving anemia due to qi and blood deficiency according to claim 3, characterized in that, In the raw material pretreatment step, processed Polygonum multiflorum is mixed with rice wine at 20% of its weight, sealed and moistened for 2-3 hours, then steamed at 103-107℃ for 2.5-3.5 hours, cooled, and pulverized to 80-100 mesh to obtain pretreated processed Polygonum multiflorum; ginseng, astragalus, and chuanxiong are pulverized to 80-100 mesh and mixed with the pretreated processed Polygonum multiflorum to obtain a fat-soluble medicinal mixture.

5. The method for preparing a traditional Chinese medicine composition for improving anemia due to qi and blood deficiency according to claim 3, characterized in that, In the fat-soluble component extraction step, the fat-soluble medicinal material mixture is put into a supercritical CO2 extraction device, the extraction pressure is set to 28-32MPa, the extraction temperature to 43-47℃, the CO2 flow rate to 20-25L / h, the extraction is carried out for 1.5-2.5h, the extract is collected, and the fat-soluble active components are obtained.

6. The method for preparing a traditional Chinese medicine composition for improving anemia due to qi and blood deficiency according to claim 3, characterized in that, In the water-soluble component extraction step, the prepared Rehmannia root, Angelica sinensis, Spatholobus suberectus, mulberry, wolfberry, and stir-fried white peony root are washed, cut into sections, and soaked in 8-10 times their weight of purified water for 1-1.5 hours. Then, the mixture is heated to boiling and simmered at a gentle boil for 1.2-1.8 hours. The decoction is then filtered to obtain the first decoction. The dregs are added to 6-8 times their weight of purified water and simmered again for 1-1.5 hours. The decoction is then filtered to obtain the second decoction. The two decoctions are combined and concentrated under reduced pressure to a clear extract with a relative density of 1.10-1.15 to obtain the water-soluble concentrate.

7. The method for preparing a traditional Chinese medicine composition for improving anemia due to qi and blood deficiency according to claim 3, characterized in that, In the purification process, the water-soluble concentrate is passed through a D101 macroporous resin column. First, it is eluted with 3-5 BV of purified water to remove impurities, and then eluted with 60-80% ethanol solution. The ethanol eluent is collected, and the ethanol is recovered under reduced pressure until there is no alcohol odor, thus obtaining the water-soluble purified solution.

8. The method for preparing a traditional Chinese medicine composition for improving anemia due to qi and blood deficiency according to claim 3, characterized in that, In the mixing and drying step, the fat-soluble active ingredient is added to the water-soluble purified solution and stirred until completely dissolved. The solution is then dried using a spray drying device with an inlet air temperature of 175-185℃, an outlet air temperature of 75-85℃, and a feed rate of 10-15mL / min to obtain dry extract powder.

9. A method for preparing a traditional Chinese medicine composition for improving anemia due to qi and blood deficiency according to claim 3, characterized in that, In the formulation forming step, the dry extract powder is mixed with microcrystalline cellulose (weight ratio 1:0.3-0.5) and hydroxypropyl methylcellulose (weight ratio 1:0.1-0.2), purified water is added to form a soft material, and microsphere cores are prepared using an extrusion-spheronization machine with an extrusion speed of 300-400 r / min and a spheronization speed of 800-1000 r / min. Ethyl cellulose is dissolved in 5-8% ethanol, and the microsphere cores are coated using a fluidized bed coating machine with an inlet air temperature of 40-45℃ and an atomization pressure of 0.2-0.3 MPa. The coating weight gain is 5-8%, and the sustained-release microsphere formulation is obtained after cooling.

10. A method for preparing a traditional Chinese medicine composition for improving anemia due to qi and blood deficiency according to claim 9, characterized in that, In the formulation forming step, the weight ratio of dry extract powder to microcrystalline cellulose is 1:0.3-0.5, and the weight ratio of dry extract powder to hydroxypropyl methylcellulose is 1:0.1-0.2.

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