A medicinal composition for nourishing yin and blood and a preparation method and application thereof

Abstract

This invention provides a yin-nourishing and blood-tonifying medicinal composition, its preparation method, and its application, belonging to the technical field of traditional Chinese medicine compositions. The active ingredients of this composition are prepared from the following raw materials in parts by weight: Astragalus membranaceus 2-3 parts, Angelica sinensis 12-18 parts, Crataegus pinnatifida 2-3 parts, Glycyrrhiza uralensis 2-5 parts, Chrysanthemum indicum 5-9 parts, Melon japonica 20-30 parts, Lemon 15-19 parts, Fine corn flour 2-3 parts, and Whole milk powder 40-44 parts, wherein the weight ratio of Angelica sinensis to Astragalus membranaceus is (6-9):1. The composition of this invention can be prepared into various oral preparations using conventional pharmaceutical processes. The preparation process is stable and controllable, suitable for industrial production. This composition possesses the effects of nourishing yin and blood, strengthening the spleen and promoting digestion, is safe with no toxic side effects, and has an excellent taste. It can be used to prepare drugs for treating and improving yin and blood deficiency syndromes, and has good clinical application and industrialization prospects.

Description

Technical Field

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

[0002] Yin and blood deficiency is a common syndrome in traditional Chinese medicine. Yin deficiency and blood deficiency often coexist and influence each other, and are frequently seen in people who are chronically overworked, have irregular sleep patterns, are women during menstruation / postpartum / menopause, or are middle-aged or elderly people with weak constitutions. Clinical manifestations mainly include dry mouth and throat, hot flashes and night sweats, dizziness and tinnitus, palpitations and insomnia, pale or sallow complexion, fatigue, cold hands and feet, and irregular menstruation, which seriously affect quality of life.

[0003] Traditional Chinese medicine has well-established theories and formulas for nourishing yin and blood, such as Dang Gui Bu Xue Tang, Si Wu Tang, and Liu Wei Di Huang Wan series, each with its own emphasis on nourishing blood, yin, and qi. However, current technology and commercially available products still have the following shortcomings: most traditional formulas tend to be warming and drying in nourishing blood, which can easily exacerbate yin deficiency; or they tend to be nourishing and cloying in nourishing yin, which can easily impair the stomach and spleen, making it difficult to simultaneously achieve "nourishing blood without causing dryness and nourishing yin without being cloying." Traditional decoctions and granules have a strong bitter taste and strong odor, resulting in poor long-term adherence and making them unsuitable for daily long-term conditioning. The generation of qi and blood depends on the spleen and stomach's function of transformation and transportation. Most formulas only focus on directly nourishing blood or yin, neglecting to strengthen the spleen and promote absorption, thus limiting the efficacy of the medicine. Some prepared Chinese medicines have complex ingredients and many medicinal flavors, making them unsuitable for people with sensitive constitutions or for long-term health maintenance.

[0004] With the fast pace of modern life, the incidence of yin deficiency and blood deficiency in young adults and women continues to rise. Clinically, there is an urgent need for a safe, mild, palatable, scientifically formulated, and long-term food-based conditioning solution that combines yin nourishment and blood replenishment with spleen strengthening and digestion assistance. Summary of the Invention

[0005] This invention provides a yin-nourishing and blood-tonifying medicinal composition, its preparation method, and its application, in order to overcome the deficiencies in the prior art.

[0006] This invention provides a medicinal composition for nourishing Yin and blood, the composition comprising active ingredients and pharmaceutically acceptable excipients; the active ingredients are prepared from the following raw materials in parts by weight: Astragalus membranaceus 2-3 parts, Angelica sinensis 12-18 parts, Crataegus pinnatifida 2-3 parts, Glycyrrhiza uralensis 2-5 parts, Chrysanthemum indicum 5-9 parts, Melon japonica 20-30 parts, Lemon 15-19 parts, Fine corn flour 2-3 parts, and Whole milk powder 40-44 parts.

[0007] According to the present invention, a medicinal composition for nourishing Yin and blood is provided, wherein the weight ratio of Angelica sinensis to Astragalus membranaceus in the active ingredients is (6-9):1.

[0008] According to the present invention, a medicinal composition for nourishing Yin and blood is provided, wherein the active ingredients are prepared from the following raw materials in parts by weight: Astragalus membranaceus 2.5 parts, Angelica sinensis 15 parts, Crataegus pinnatifida 2.5 parts, Glycyrrhiza uralensis 3.5 parts, Chrysanthemum indicum 7 parts, Melon japonica 25 parts, Lemon 17 parts, Fine corn flour 2.5 parts, and Whole milk powder 42 parts.

[0009] According to the present invention, a medicinal composition for nourishing yin and blood is provided, wherein the pharmaceutically acceptable excipients are selected from one or more of fillers, lubricants, preservatives, wetting agents, binders, antioxidants, light-blocking agents, flavoring agents, and antibacterial agents.

[0010] According to the present invention, a medicinal composition for nourishing Yin and blood is provided, wherein the composition is an oral preparation, and the oral preparation is any one of tablets, capsules, granules, powders, pills, and oral solutions.

[0011] A method for preparing the yin-nourishing and blood-tonifying medicinal composition as described in any of the preceding claims is provided, comprising the following steps: S1. Raw material pretreatment: Weigh the raw materials of Astragalus membranaceus, Angelica sinensis, hawthorn, licorice, chrysanthemum morifolium, bitter melon and lemon as described in claim 1 according to the weight parts, wash them and dry them at low temperature until the moisture content of the raw materials is ≤3.0%, cool them to room temperature and then crush them and sieve them to obtain fine powder of traditional Chinese medicine. S2. Mixing: The fine powder of traditional Chinese medicine obtained in step S1 is mixed evenly with the fine corn flour and whole milk powder as described in claim 1 to obtain a mixture of active ingredients; S3. Formulation preparation: The active ingredient mixture obtained in step S2 is mixed with pharmaceutically acceptable excipients and prepared into an oral formulation according to conventional pharmaceutical processes.

[0012] According to the preparation method of the Yin-nourishing and blood-tonifying medicinal composition provided by the present invention, in step S1, the temperature of the low-temperature drying is 60-80℃, and the powder is passed through a 100-120 mesh sieve; in step S2, the mixing adopts a gradient mixing method, first premixing the fine powder of traditional Chinese medicine with fine corn flour evenly, and then adding whole milk powder to mix until the powder color is uniform, and the relative humidity of the environment during the mixing process is controlled at 40%-60%.

[0013] According to the present invention, a method for preparing a yin-nourishing and blood-tonifying medicinal composition is provided. In step S3, when preparing an oral solution, the active ingredient mixture is mixed with purified water, and optional flavoring agents, antibacterial agents, and antioxidants are added. After stirring and dissolving, the mixture is brought to a final volume, filtered, dispensed, and terminally sterilized to obtain the finished product. The terminal sterilization is performed using any one of moist heat sterilization, dry heat sterilization, or irradiation sterilization. When preparing tablets, capsules, or granules, the active ingredient mixture is mixed with excipients, granulated using dry granulation or wet granulation processes, and then tableted, capsule-filled, or dispensed to obtain the corresponding solid dosage form.

[0014] The use of the above-described yin-nourishing and blood-tonifying medicinal composition in the preparation of a medicament for treating and improving yin and blood deficiency syndrome is provided.

[0015] The symptoms corresponding to the Yin and Blood Deficiency Syndrome are selected from one or more of the following: dry mouth and throat, hot flashes and night sweats, palpitations and insomnia, pale complexion, dizziness and tinnitus, cold hands and feet, fatigue and weakness, and irregular menstruation in women; the dosage of the drug is twice a day, each time 10-15g based on the active ingredient.

[0016] The present invention provides a yin-nourishing and blood-tonifying medicinal composition, its preparation method, and its application, which have the following beneficial effects: (1) It can significantly increase the number of red blood cells and hemoglobin content in mice with blood deficiency, and improve symptoms of blood deficiency such as pale complexion, lethargy, and weight loss; clinically, it can quickly relieve symptoms such as dizziness, fatigue, palpitations, and poor complexion. It can significantly reduce serum T3 and T4 levels in mice with yin deficiency, downregulate cAMP and increase cGMP content, correct the state of yin deficiency and internal heat, and improve symptoms such as dry mouth, hot flashes, night sweats, and insomnia.

[0017] (2) The formula works synergistically to achieve the triple effects of nourishing yin, nourishing blood, and strengthening the spleen; Angelica sinensis is the chief ingredient, which effectively nourishes and invigorates blood; Astragalus membranaceus replenishes qi to generate blood, assisting Angelica sinensis in enhancing its effects; Chrysanthemum morifolium, bitter melon, and lemon clear heat, nourish yin, cool blood, and detoxify, avoiding the warming and drying effects of nourishing blood; Hawthorn, licorice, and cornstarch strengthen the spleen and stomach, promote digestion and digestion, and facilitate nutrient absorption and qi and blood production; whole milk powder supplements high-quality protein, works synergistically to nourish blood, and improves physical constitution. Overall, it nourishes yin without being greasy, nourishes blood without being warming and drying, clears heat without harming the body's vital energy, and strengthens the spleen without causing stagnation.

[0018] (3) The taste of the medicine is improved by blending fine corn flour and whole milk powder, which greatly improves the bitter taste of traditional Chinese medicine. It has a high taste score and is suitable for long-term use. All raw materials are made from food and medicine homologous materials and food-grade excipients. Animal and clinical observations have shown no adverse reactions. It is suitable for a wide range of groups such as women, people with weak constitutions, and people who are tired from long-term work. It can be used for both daily conditioning and treatment.

[0019] (4) It adopts low-temperature drying, ultra-fine pulverization, gradient mixing and conventional preparation process. The conditions are mild and the quality is stable. It can be made into a variety of dosage forms such as tablets, capsules, granules, powders, oral liquids and pills to meet different use scenarios. The effect is mild and long-lasting and there is no rebound. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0021] Figure 1This is an analysis diagram of the results of the orthogonal experiment for screening the composition formulation in Experiment Example 1 of the present invention, which is a medicinal composition for nourishing yin and blood and its preparation method. In this diagram, (A) is the predicted value of the taste score minus the actual value, (B) is the predicted value of the clinical score minus the actual value, and (C) is the analysis result diagram of the effect test-predictive characterizer. Figure 2 This is a statistical chart of the effect of the Yin-nourishing and blood-tonifying medicinal composition and its preparation method on the intervention effect of the composition in Experimental Example 2 on a mouse model of blood deficiency syndrome. Among them, (A) is the weight statistical chart of the normal group, the model group and the treatment group, (B) is the RBC statistical chart of the normal group, the model group and the treatment group, and (C) is the hemoglobin statistical chart of the normal group, the model group and the treatment group.

[0022] Figure 3 This is a statistical chart of the intervention effect of the Yin-nourishing and blood-tonifying medicinal composition and its preparation method and application in Experimental Example 3 of the present invention on mice with kidney Yin deficiency syndrome. Among them, (A) T3 statistical chart of normal group, model group and treatment group, (B) T4 statistical chart of normal group, model group and treatment group, (C) cAMP statistical chart of normal group, model group and treatment group, and (D) cGMP statistical chart of normal group, model group and treatment group. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0024] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0025] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0026] In the description of the embodiments of the present invention, it should be noted that the terms "inner", "outer", "upper", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the present invention. Example 1

[0027] The composition of this embodiment is prepared from the following raw materials by weight: Astragalus membranaceus 25g, Angelica sinensis 150g, Crataegus pinnatifida 25g, Glycyrrhiza uralensis 35g, Chrysanthemum indicum 70g, Melon japonica 250g, Lemon 170g, Fine corn flour 25g, and Whole milk powder 420g. In this embodiment, the weight ratio of Angelica sinensis to Astragalus membranaceus is 6:1, which is within the range of (6 to 9):1. Example 2

[0028] The composition of this embodiment is prepared from the following raw materials by weight: 20g Astragalus membranaceus, 120g Angelica sinensis, 20g Crataegus pinnatifida, 20g Glycyrrhiza uralensis, 50g Chrysanthemum indicum, 200g Melon japonica, 150g Lemon, 20g Fine corn flour, and 400g Whole milk powder. In this embodiment, the weight ratio of Angelica sinensis to Astragalus membranaceus is 6:1, which is within the range of (6 to 9):1. Example 3

[0029] The composition of this embodiment is prepared from the following raw materials by weight: Astragalus membranaceus 30g, Angelica sinensis 180g, Crataegus pinnatifida 30g, Glycyrrhiza uralensis 50g, Chrysanthemum indicum 90g, Melon japonica 300g, Lemon 190g, Fine corn flour 30g, and Whole milk powder 440g. In this embodiment, the weight ratio of Angelica sinensis to Astragalus membranaceus is 6:1, which is within the range of (6 to 9):1. Example 4

[0030] The powder preparation method in this embodiment is as follows: S1. Raw material pretreatment: Weigh out Astragalus membranaceus, Angelica sinensis, hawthorn, licorice, chrysanthemum morifolium, bitter melon and lemon according to the weight of Example 1. After washing, place them in a hot air circulating oven and dry them at a low temperature of 70°C until the moisture content of the raw materials is ≤3.0%. Take them out and cool them to room temperature. Then, crush them with a hammer mill and pass them through a 100-mesh sieve to obtain fine powder of Chinese medicine. S2. Gradient mixing: Place the fine powder of traditional Chinese medicine obtained in step S1 and fine corn powder in a three-dimensional motion mixer, premix for 15 minutes until uniform, then add whole milk powder and continue mixing for 20 minutes until the powder color is uniform. During the mixing process, the relative humidity of the environment is controlled at 50% to obtain a mixture of active ingredients. S3. Packaging: The active ingredient mixture is packaged in aluminum-plastic composite film at 12g / bag, sealed, and the powder product is obtained. Example 5

[0031] The steps for preparing the capsules in this embodiment are as follows: S1. Raw material pretreatment: Same as step S1 in Example 4; S2, Gradient Mixing: Same as step S2 in Example 4, to obtain a mixture of active ingredients; S3. Granulation and Filling: Pharmaceutically acceptable excipients microcrystalline cellulose (filler) and magnesium stearate (lubricant) are added to the active ingredient mixture, wherein the weight ratio of active ingredient mixture: microcrystalline cellulose: magnesium stearate is 100:20:1. After mixing evenly, the mixture is granulated using a dry granulator, passed through a 20-mesh sieve, and then filled into No. 0 hard capsule shells using a fully automatic capsule filling machine, with each capsule containing 0.5g, thus obtaining the finished capsule product. Example 6

[0032] The tablets are prepared in this embodiment using the following steps: S1. Raw material pretreatment: Same as step S1 in Example 4; S2, Gradient Mixing: Same as step S2 in Example 4, to obtain a mixture of active ingredients; S3. Granulation and tableting: Pharmaceutically acceptable excipients, pregelatinized starch (filler), crospovidone (disintegrant), and magnesium stearate (lubricant), are added to the active ingredient mixture. The weight ratio of the active ingredient mixture to pregelatinized starch to crospovidone to magnesium stearate is 100:15:3:0.8. After mixing evenly, the mixture is granulated using a wet granulation machine, dried at 60°C until the moisture content is ≤5.0%, granulated through an 18-mesh sieve, and then compressed into tablets using a rotary tableting machine. Each tablet weighs 0.6g, thus obtaining the finished tablet product. Example 7

[0033] The steps for preparing granules in this embodiment are as follows: S1. Raw material pretreatment: Same as step S1 in Example 4; S2, Gradient Mixing: Same as step S2 in Example 4, to obtain a mixture of active ingredients; S3. Granulation and Packaging: Add pharmaceutically acceptable excipients mannitol and steviol glycosides to the active ingredient mixture, mix evenly, prepare a soft mass using 75% ethanol as a wetting agent, granulate through a 14-mesh sieve, dry at 65℃ until the moisture content is ≤4.0%, granulate through a 12-mesh sieve, and package in 10g / bags to obtain the finished granule product. Example 8

[0034] The steps for preparing the oral solution in this embodiment are as follows: S1. Raw material pretreatment: Same as step S1 in Example 4, to obtain fine powder of traditional Chinese medicine; S2. Extraction and preparation: Add the fine powder of Chinese herbal medicine to 10 times the amount of purified water, soak twice at 80℃ for 1 hour each time, combine the extracts, filter, and concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.05-1.10 (60℃); add fine corn flour and whole milk powder to the clear extract, stir until completely dissolved, then add pharmaceutically acceptable excipients sucrose (flavoring agent), potassium sorbate (bacteriostatic agent), and vitamin C (antioxidant), add purified water to the total volume, and stir evenly; S3. Sterilization and dispensing: The prepared drug solution is filtered through a 0.22μm microporous membrane, filled into 10mL brown glass bottles, capped, and sterilized by moist heat at 121℃ for 15min to obtain the oral solution product.

[0035] Experimental Example 1 This experimental example is used to optimize the ratio of raw materials in the composition, verify the scientific validity and non-obviousness of the formulation, and screen the optimal formulation that balances clinical efficacy and taste.

[0036] Experimental factors and level settings: Nine factors were investigated, including Astragalus membranaceus, Angelica sinensis, hawthorn, licorice, chrysanthemum morifolium, bitter melon, lemon, fine corn flour, and whole milk powder. Each factor had two levels and one center point. An orthogonal experiment was designed using JMP 17.0 software. The level settings for each factor are shown in Table 1 below. Table 1. Factor Level Table for Orthogonal Experiment Experimental methods: Sixteen groups of compositions were prepared according to the orthogonal design table. The preparation method was as follows: Astragalus membranaceus, Angelica sinensis, hawthorn, licorice, chrysanthemum morifolium, bitter melon and lemon were weighed according to the weight parts, washed and dried at 80℃ until the moisture content was ≤3.0%, cooled to room temperature and then pulverized through a 100-mesh sieve to obtain fine powder of Chinese medicine; the fine powder of Chinese medicine was mixed evenly with fine corn flour and whole milk powder to obtain the composition powder.

[0037] Evaluation indicators (1) Taste score: 12g of each group's composition powder was dissolved in 200mL of 40℃ warm water, and 20 healthy volunteers were invited to taste it blindly. The evaluation dimensions were bitterness, off-flavor, smoothness, and acceptability. The full score was 10 points, and the higher the score, the better the taste. (2) Clinical efficacy score: 80 female subjects diagnosed with Yin and Blood Deficiency Syndrome by TCM were selected and randomly divided into 16 groups with 5 subjects in each group. Each group of subjects took the corresponding composition twice a day, 12g each time, dissolved in warm water, for 4 consecutive weeks. The improvement of dizziness, sleep, menstrual abnormalities, and palpitations were used as evaluation indicators. Each indicator had a full score of 5 points, and the total score was 20 points. The higher the score, the better the efficacy.

[0038] Orthogonal experimental design and results: The orthogonal experimental design and results are as follows Figure 1 And as shown in Table 2 below: Table 2 Orthogonal Experimental Design and Results Results analysis: The experimental data were analyzed using JMP17.0 software. The results showed that: (1) In terms of taste: whole milk powder had the most significant positive effect on taste. The increase in the amount of hawthorn, licorice, bitter chrysanthemum, bitter melon, lemon, and fine corn flour was negatively correlated with taste. The central point group (group 1) had the highest taste score, reaching 9 points, which was significantly better than other groups. (2) In terms of clinical efficacy: Angelica sinensis had the most significant positive effect on clinical scores. The increase in the amount of Angelica sinensis could significantly improve the efficacy. The increase in the amount of hawthorn, licorice, lemon, and fine corn flour was negatively correlated with clinical scores. The central point group (group 1) had the highest clinical score, reaching 18 points, which was significantly better than other groups. (3) Comprehensive analysis: The central group (Astragalus membranaceus 2.5 parts, Angelica sinensis 15 parts, hawthorn 2.5 parts, licorice 3.5 parts, bitter chrysanthemum 7 parts, bitter melon 25 parts, lemon 17 parts, fine corn flour 2.5 parts, whole milk powder 42 parts) has the best taste and clinical efficacy. Moreover, the weight ratio of Angelica sinensis to Astragalus membranaceus is 6:1, which is within the ratio range of (6-9):1. Therefore, it is determined to be the optimal formula of the present invention.

[0039] Experiment Example 2 This experimental example is used to verify the blood-nourishing and blood-tonifying effects of the composition of the present invention, and to provide experimental evidence for its application in the treatment of blood deficiency syndrome.

[0040] Experimental materials: (1) Experimental animals: 30 SPF-grade C57BL / 6 mice, half male and half female, 6 months old, weighing 18-22g, provided by a compliant experimental animal center, housed in an SPF-grade animal room with a temperature of 22±3℃, humidity of 40-60%RH, and 12h light-dark alternation, with free access to food and water. (2) Test drug: The powder of the composition prepared in Example 1; (3) Reagents and instruments: Cyclophosphamide, acetylphenylhydrazine (both analytical grade); fully automated blood cell analyzer; electronic balance.

[0041] Experimental methods: (1) Grouping and modeling: Mice were randomly divided into normal group, model group and treatment group, with 10 mice in each group. The model group and treatment group were prepared by intraperitoneal injection of cyclophosphamide combined with subcutaneous injection of acetylphenylhydrazine: cyclophosphamide 60mg / kg was injected intraperitoneally on the 4th and 8th days of the experiment, and acetylphenylhydrazine 100mg / kg was injected subcutaneously on the 7th and 10th days; the normal group was injected with an equal volume of physiological saline. (2) Administration method: The administration began at the same time as the model was established. The treatment group was given the combined powder by gavage daily at a dose of 60mg / kg (based on the active ingredient); the normal group and model group were given an equal volume of physiological saline by gavage daily for 14 consecutive days. (3) Detection indicators: During the experiment, the general physical signs (coat color, mental state, activity level) of the mice were observed daily, and the weight was recorded every 3 days; on the 14th day of the experiment, blood was collected from the fundus venous plexus of the mice, and the number of red blood cells (RBC) and the content of hemoglobin (HGB) were detected by a fully automated blood cell analyzer. (4) Statistical methods: SPSS 26.0 software was used for data analysis. Quantitative data were expressed as mean ± standard deviation. The t-test was used for comparison between groups. P < 0.05 was considered statistically significant.

[0042] Experimental results: (1) General signs: Mice in the normal group had shiny fur, good mental state, and normal activity; mice in the model group showed lethargy, closed eyes and curled up, pale tail, ears and eyes, dull fur, and significant weight loss after modeling (P<0.01); mice in the treatment group showed significant improvement in the above symptoms, increased activity, restored fur luster, and significantly increased weight compared to the model group (P<0.01). (2) Blood routine indicators: Compared with the normal group, mice in the model group had significantly lower RBC count and HGB content (P<0.001); compared with the model group, mice in the treatment group had significantly higher RBC count and HGB content (P<0.001), as shown in the specific results. Figure 2 And as shown in Table 3 below: Table 3 Comparison of blood routine indicators in mice of different groups (n=10, x±s) Compared with the normal group, ***P<0.001; compared with the model group, ###P<0.001.

[0043] Experimental conclusion: The yin-nourishing and blood-tonifying medicinal composition can significantly improve the blood deficiency symptoms in mice with blood deficiency syndrome, increase the number of red blood cells and the content of hemoglobin, and has significant blood-nourishing and blood-tonifying effects.

[0044] Experimental Example 3 This experimental example is used to verify the yin-nourishing and heat-clearing effects of the composition of the present invention, and to provide experimental evidence for its application in the treatment of yin deficiency syndrome.

[0045] Experimental materials: (1) Experimental animals: 30 SPF grade C57BL / 6 mice, half male and half female, 6 months old, weighing 18~22g, source and breeding environment are the same as in Experiment 2; (2) Test drug: the powder of the composition prepared in Example 1; (3) Reagents and instruments: thyroxine tablets, reserpine (both analytical grade); ELISA kit (T3, T4, cAMP, cGMP); enzyme reader; high-speed refrigerated centrifuge.

[0046] Experimental methods: (1) Grouping and modeling: Mice were randomly divided into normal group, model group and treatment group, with 10 mice in each group. The model group and treatment group were prepared by gavage with thyroxine and reserpine: thyroxine 120mg / kg + reserpine 0.8mg / kg were administered by gavage daily for 10 consecutive days; the normal group was administered an equal volume of physiological saline by gavage. (2) Administration method: Administration was started at the same time as modeling. The treatment group was administered the powder of the combination by gavage daily at a dose of 60mg / kg (based on active ingredient); the normal group and model group were administered an equal volume of physiological saline by gavage daily for 10 consecutive days. (3) Detection indicators: 2 hours after the last administration, blood was collected from the abdominal aorta of the mice, and serum and plasma were separated. The serum triiodothyronine (T3) and thyroxine (T4) content and the plasma cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP) content were detected by ELISA kit. (4) Statistical method: Same as Experiment 2.

[0047] Experimental Results: Compared with the normal group, the model group mice showed significantly increased serum T3 and T4 levels (P<0.01), significantly increased plasma cAMP levels (P<0.001), and significantly decreased cGMP levels (P<0.001), consistent with the characteristics of kidney yin deficiency syndrome. Compared with the model group, the treatment group mice showed significantly decreased T3 and T4 levels (P<0.01), significantly decreased cAMP levels (P<0.01), and significantly increased cGMP levels (P<0.01). Specific results are as follows: Figure 3 And as shown in Table 4 below: Table 4 Comparison of Yin Deficiency-Related Indicators among Different Groups of Mice (n=10, x±s) Compared with the normal group, **P<0.01, ***P<0.001; compared with the model group, ##P<0.01.

[0048] Experimental conclusion: The Yin-nourishing and blood-tonifying medicinal composition can significantly regulate the thyroid hormone level and cyclic nucleotide balance in mice with kidney Yin deficiency syndrome, correct the Yin deficiency and internal heat state, and has significant Yin-nourishing and heat-clearing effects.

[0049] Experiment Example 4 This experimental example is used to verify the clinical efficacy and safety of the composition of the present invention in improving Yin and Blood Deficiency Syndrome, and to provide data support for its clinical application.

[0050] One hundred subjects diagnosed with Yin and Blood Deficiency Syndrome according to Traditional Chinese Medicine (TCM) were selected. The participants were half male and half female, aged 20-55 years (mean age 40 years), with a disease duration of more than 3 months. Inclusion criteria: Meeting the TCM diagnostic criteria for Yin and Blood Deficiency Syndrome, exhibiting one or more of the following symptoms: dry mouth and throat, hot flashes and night sweats, palpitations and insomnia, pale complexion, dizziness and tinnitus, fatigue, and menstrual irregularities in women. Exclusion criteria included severe cardiovascular, hepatic, and renal diseases; pregnant or lactating women; and those allergic to the raw materials of this invention. This study was approved by the ethics committee, and all participants signed informed consent forms.

[0051] Grouping method: Subjects were randomly divided into a treatment group and a control group using a random number table, with 50 subjects in each group. There were no statistically significant differences in age, gender, disease duration, and symptom severity between the two groups (P>0.05), making them comparable.

[0052] Intervention Methods: Treatment Group: Administered the powdered composition prepared in Example 1, 12g twice daily, dissolved in 40℃ warm water, for one month. Control Group: Received a placebo (corn flour + whole milk powder, with appearance and taste identical to the test drug), administered in the same manner as the treatment group.

[0053] The criteria for determining efficacy are as follows: Effective: The subject's discomfort symptoms are significantly improved or disappear, and the TCM syndrome score decreases by ≥70%; Ineffective: The subject's discomfort symptoms do not change significantly, and the TCM syndrome score decreases by <30%.

[0054] Observation results: (1) Clinical efficacy rate: In the treatment group of 50 cases, 45 cases were effective and 5 cases were ineffective, with a total efficacy rate of 90%; in the control group of 50 cases, 0 cases were effective and 50 cases were ineffective, with a total efficacy rate of 0%. The difference between the two groups was statistically significant (P<0.001). (2) Onset time: In the treatment group, 5 subjects showed significant improvement in symptoms in the first week of administration, and 30 subjects showed significant improvement in symptoms in the fourth week of administration. The onset of effect was mild and long-lasting, with no rebound. (3) Safety: No adverse reactions such as nausea, vomiting, diarrhea, or allergies occurred in any of the subjects in the treatment group during the administration period. Liver and kidney function tests were normal, indicating that the composition of the present invention is safe and has no toxic side effects and can be taken for a long time.

[0055] Experimental conclusion: The Yin-nourishing and blood-tonifying medicinal composition can significantly improve the clinical symptoms of subjects with Yin and blood deficiency syndrome, with a high overall effective rate, good safety, and good clinical application value.

[0056] Therefore, it is evident that the Yin-nourishing and blood-tonifying medicinal composition, its preparation method, and its application provided by this invention can significantly increase the number of red blood cells and hemoglobin content in blood-deficient model mice, and improve blood-deficient symptoms such as pale complexion, lethargy, and weight loss; clinically, it can quickly relieve symptoms such as dizziness, fatigue, palpitations, and poor complexion. It can significantly reduce serum T3 and T4 levels in Yin-deficient model mice, downregulate cAMP and increase cGMP content, correct the Yin-deficient internal heat state, and improve symptoms such as dry mouth, hot flashes, night sweats, and insomnia. The synergistic combination achieves the triple effects of nourishing Yin, tonifying blood, and strengthening the spleen; Angelica sinensis is the principal ingredient, powerfully nourishing and invigorating blood; Astragalus membranaceus tonifies Qi to generate blood, assisting Angelica sinensis in enhancing its effects; Chrysanthemum morifolium, bitter melon, and lemon clear heat, nourish Yin, cool blood, and detoxify, avoiding the warming and drying effects of blood tonification; Hawthorn, licorice, and corn flour strengthen the spleen and stomach, aid digestion, and promote nutrient absorption and Qi and blood production; whole milk powder supplements high-quality protein, synergistically nourishing blood and improving physical constitution. Overall, it nourishes Yin without being greasy, nourishes blood without being warming or drying, clears heat without harming the body's vital energy, and strengthens the spleen without causing stagnation.

[0057] This product uses fine cornstarch and whole milk powder to harmonize the medicinal flavor, significantly improving the bitter and astringent taste of traditional Chinese medicine, resulting in a high taste rating and suitability for long-term use. It utilizes only food-grade ingredients and food-grade excipients, and has shown no adverse reactions in animal and clinical trials. Suitable for a wide range of groups, including women, those with weak constitutions, and those experiencing chronic fatigue, it can be used for both daily conditioning and treatment. Employing low-temperature drying, ultra-fine pulverization, gradient mixing, and conventional formulation processes, it maintains mild conditions and stable quality, allowing for the production of various dosage forms such as tablets, capsules, granules, powders, oral liquids, and pills to meet different usage scenarios. Its effects are mild and long-lasting, with no rebound effect.

[0058] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A medicinal composition for nourishing Yin and blood, characterized in that, The composition comprises an active ingredient and pharmaceutically acceptable excipients; the active ingredient is prepared from the following raw materials in parts by weight: 2-3 parts Astragalus membranaceus, 12-18 parts Angelica sinensis, 2-3 parts Crataegus pinnatifida, 2-5 parts Glycyrrhiza uralensis, 5-9 parts Chrysanthemum indicum, 20-30 parts Bitter melon, 15-19 parts Lemon, 2-3 parts Fine corn flour, and 40-44 parts Whole milk powder.

2. The medicinal composition for nourishing Yin and blood according to claim 1, characterized in that, In the active ingredients, the weight ratio of Angelica sinensis to Astragalus membranaceus is (6-9):

1.

3. The medicinal composition for nourishing Yin and blood according to claim 1, characterized in that, The active ingredients are prepared from the following raw materials in parts by weight: Astragalus membranaceus 2.5 parts, Angelica sinensis 15 parts, Crataegus pinnatifida 2.5 parts, Glycyrrhiza uralensis 3.5 parts, Chrysanthemum indicum 7 parts, Melon japonica 25 parts, Lemon 17 parts, Fine corn flour 2.5 parts, and Whole milk powder 42 parts.

4. The medicinal composition for nourishing Yin and blood according to claim 1, characterized in that, The pharmaceutically acceptable excipients are selected from one or more of the following: fillers, lubricants, preservatives, wetting agents, binders, antioxidants, opacifiers, flavoring agents, and antibacterial agents.

5. The medicinal composition for nourishing Yin and blood according to claim 1, characterized in that, The composition is an oral preparation, which is any one of tablets, capsules, granules, powders, pills, or oral solutions.

6. A method for preparing a yin-nourishing and blood-tonifying medicinal composition as described in any one of claims 1-5, characterized in that, Includes the following steps: S1. Raw material pretreatment: Weigh the raw materials of Astragalus membranaceus, Angelica sinensis, hawthorn, licorice, chrysanthemum morifolium, bitter melon and lemon as described in claim 1 according to the weight parts, wash them and dry them at low temperature until the moisture content of the raw materials is ≤3.0%, cool them to room temperature and then crush them and sieve them to obtain fine powder of traditional Chinese medicine. S2. Mixing: The fine powder of traditional Chinese medicine obtained in step S1 is mixed evenly with the fine corn flour and whole milk powder as described in claim 1 to obtain a mixture of active ingredients; S3. Formulation preparation: The active ingredient mixture obtained in step S2 is mixed with pharmaceutically acceptable excipients and prepared into an oral formulation according to conventional pharmaceutical processes.

7. The method for preparing the Yin-nourishing and blood-tonifying medicinal composition according to claim 6, characterized in that, In step S1, the temperature of the low-temperature drying is 60-80℃, and the powder is passed through a 100-120 mesh sieve. In step S2, the mixing adopts a gradient mixing method, first premixing the fine powder of Chinese medicine with fine corn flour evenly, and then adding whole milk powder to mix until the powder color is uniform. The relative humidity of the environment during the mixing process is controlled at 40%-60%.

8. The method for preparing the Yin-nourishing and blood-tonifying medicinal composition according to claim 6, characterized in that, In step S3, when preparing an oral solution, the active ingredient mixture is mixed with purified water, and optional flavoring agents, antibacterial agents, and antioxidants are added. After stirring and dissolving, the mixture is brought to a final volume, filtered, dispensed, and terminally sterilized to obtain the finished product. The terminal sterilization is performed using any one of moist heat sterilization, dry heat sterilization, or irradiation sterilization. When preparing tablets, capsules, or granules, the active ingredient mixture is mixed with excipients, granulated using dry granulation or wet granulation processes, and then tableted, capsule-filled, or dispensed to obtain the corresponding solid dosage form.

9. The use of a yin-nourishing and blood-tonifying medicinal composition as described in any one of claims 1-5 in the preparation of a medicament for treating and improving yin and blood deficiency syndrome.

10. The application according to claim 9, characterized in that, The symptoms corresponding to the Yin and Blood Deficiency Syndrome are selected from one or more of the following: dry mouth and throat, hot flashes and night sweats, palpitations and insomnia, pale complexion, dizziness and tinnitus, cold hands and feet, fatigue and weakness, and irregular menstruation in women; the dosage of the drug is twice a day, each time 10-15g based on the active ingredient.

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