A traditional Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis and its preparation method

Abstract

The present invention belongs to the field of traditional Chinese medicine technology, and provides a Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, and a preparation method thereof. The Chinese medicine composition is made up of the following components by weight: 10-20 parts of Codonopsis pilosula, 6-12 parts of Astragalus membranaceus, 6-12 parts of Rhizoma Anemarrhenae, 3-8 parts of Platycodon grandiflorum, 10-20 parts of Rhizoma Dioscoreae, 3-8 parts of Santalum album, and 6-12 parts of Morinda officinalis. The prescription of the present invention is aimed at weak qi and blood, weak circulation, and blood stasis, with invigorating the spleen and qi, promoting blood circulation and removing blood stasis as the basic treatment principle, treating both the symptoms and the root causes, while invigorating qi and nourishing blood, promoting blood circulation and removing blood stasis, giving full play to the synergistic effect between the medicinal flavors. The prescription of the present invention is rigorous, the medication is precise, and the clinical applicability is strong.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, as well as a preparation method and application thereof. Background Art

[0002] Qi and blood deficiency, referred to in Traditional Chinese Medicine as qi and blood deficiency, can lead to impaired organ function, manifested by chills, spontaneous sweating, dizziness, tinnitus, fatigue, palpitations, shortness of breath, and developmental delay. Blood deficiency can cause a dull, sallow complexion, dry skin, cracked nails, blurred vision, numbness of the hands and feet, insomnia, frequent dreams, forgetfulness, palpitations, and mental confusion. According to Traditional Chinese Medicine, the main causes of blood deficiency are as follows: Some cases of blood deficiency are due to insufficient blood production, qi deficiency that cannot produce blood, or impaired organ function, such as spleen dysfunction and weak stomach qi that cannot transport and transform food and water essence into blood; some cases of blood deficiency are due to excessive and rapid blood loss, with insufficient replacement of new blood; and some cases of blood deficiency are due to prolonged illness, chronic exhaustion, or excessive mental exertion that depletes essence and blood.

[0003] Spleen deficiency syndrome reflects insufficient physiological function of the spleen, similar to the modern medical syndromes of decreased digestive function, impaired nutrient absorption, disrupted energy metabolism, decreased disease resistance, and tissue dysfunction. It involves multiple diseases across multiple systems. The Treatise on the Spleen and Stomach states, "When the spleen and stomach are deficient, the five internal organs, twelve meridians, fifteen collaterals, and four limbs are deprived of vital energy, leading to a myriad of illnesses." Therefore, spleen deficiency syndrome is a key pathological basis for numerous diseases.

[0004] Guided by the theory of qi and blood in Traditional Chinese Medicine, invigorating qi and replenishing blood are often inseparable. When qi is generated, blood is transformed, and when blood circulates, qi is nourished. Medications with simple ingredients that can replenish qi and strengthen the spleen, enhancing qi and blood production and circulation, are urgently needed. Summary of the Invention

[0005] In order to solve the above technical problems, the present invention provides a traditional Chinese medicine composition for tonifying qi and strengthening the spleen, promoting blood circulation and removing blood stasis. The traditional Chinese medicine composition for tonifying qi and strengthening the spleen, promoting blood circulation and removing blood stasis is prepared from the following components by weight: 10-20 parts of Codonopsis pilosula, 6-12 parts of Astragalus membranaceus, 6-12 parts of Anemarrhena asphodeloides, 3-8 parts of Platycodon grandiflorum, 10-20 parts of raw yam, 3-8 parts of Santalum album and 6-12 parts of Morinda officinalis.

[0006] In one embodiment of the present invention, the Chinese medicine composition is made of the following components by weight: 15 parts of Codonopsis pilosula, 9 parts of Astragalus membranaceus, 9 parts of Anemarrhena asphodeloides, 6 parts of Platycodon grandiflorum, 15 parts of Yam, 6 parts of Santalum album and 9 parts of Morinda officinalis.

[0007] In one embodiment of the present invention, the Chinese medicine composition is made of the following components by weight: 20 parts of Codonopsis pilosula, 6 parts of Astragalus membranaceus, 12 parts of Anemarrhena asphodeloides, 3 parts of Platycodon grandiflorum, 10 parts of Yam, 3 parts of Santalum album and 12 parts of Morinda officinalis.

[0008] In one embodiment of the present invention, the Chinese medicine composition is made of the following components by weight: 10 parts of Codonopsis pilosula, 12 parts of Astragalus membranaceus, 6 parts of Anemarrhena asphodeloides, 8 parts of Platycodon grandiflorum, 20 parts of Yam, 8 parts of Santalum album and 6 parts of Morinda officinalis.

[0009] The present invention also provides a method for preparing the traditional Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, comprising the following steps: weighing each raw medicinal material, crushing, soaking in water for 1-2 hours, decocting twice, each time adding water 5-8 times the total amount of the medicinal material, decocting for 0.5-1.5 hours each time, combining the decoctions, filtering, combining the filtrates, and concentrating to a relative density of 1.10-1.15.

[0010] Furthermore, the preparation method of the traditional Chinese medicine composition for replenishing qi, strengthening the spleen, promoting blood circulation and removing blood stasis comprises the following steps: weighing each raw medicinal material, crushing, soaking in water for 1 hour, decocting twice, each time adding 6 times the total amount of medicinal material, decocting for 1 hour each time, combining the decoctions, filtering, combining the filtrates, and concentrating to a relative density of 1.10.

[0011] The present invention also provides the use of the traditional Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis in the preparation of medicines for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis.

[0012] The present invention also provides the use of the traditional Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis in the preparation of medicines for treating chronic fatigue syndrome, qi and blood deficiency, and qi and blood deficiency caused by long-term overtime and staying up late.

[0013] The present invention also provides the use of the traditional Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis in the preparation of medicine for treating qi deficiency and blood stasis syndrome in the acute stage of cerebral infarction.

[0014] The medicinal properties and effects of each Chinese medicinal material in the present invention are as follows:

[0015] Codonopsis: sweet in taste, neutral in nature, enters the lung and spleen meridians, tonifies the middle and replenishes qi, quenches thirst, strengthens the spleen and benefits the lungs, nourishes blood and produces body fluids; used for spleen and lung qi deficiency, poor appetite and fatigue, cough and shortness of breath, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to loss of body fluids, internal heat and thirst.

[0016] Astragalus: sweet in nature and slightly warm in flavor, it enters the lung and spleen meridians, replenishes qi and raises yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, promotes fluid production and nourishes blood, relieves stagnation and arthritis, removes toxins and discharges pus, and heals sores and promotes tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of qi in the middle, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, sallow complexion due to blood deficiency, hemiplegia, pain and numbness, and carbuncles that are difficult to heal and that do not heal for a long time.

[0017] Anemarrhena: bitter and sweet in taste, cold in nature, enters the lung, stomach and kidney meridians, clears away heat and purges fire, promotes fluid production and moistens dryness; used for exogenous febrile diseases, high fever and thirst, lung heat and dry cough, bone steaming and hot flashes, internal heat and thirst, and dry intestines and constipation.

[0018] Platycodon grandiflorum: bitter and pungent in taste, neutral in nature, enters the lung meridian, clears the lungs, relieves sore throat, eliminates phlegm, and discharges pus; used for cough with excessive phlegm, chest tightness, sore throat and hoarseness, lung abscess and pus vomiting, etc.

[0019] Raw Chinese Yam: Sweet in flavor, neutral in nature, enters the lung, spleen, and kidney meridians; strengthens the spleen, tonifies the lungs, strengthens the kidneys, and improves essence. It treats diarrhea due to spleen deficiency, chronic dysentery, consumptive cough, polydipsia, spermatorrhea, leucorrhea, and frequent urination. It nourishes the spleen and stomach, promotes fluid production and benefits the lungs, and tonifies the kidneys and astringes essence. It is used for spleen deficiency, poor appetite, chronic diarrhea, wheezing and coughing due to lung deficiency, spermatorrhea, leucorrhea, frequent urination, and polydipsia due to deficiency-heat.

[0020] Sandalwood: spicy and warm in nature, it enters the spleen, stomach, heart and lung meridians, promotes qi and warms the middle, stimulates appetite and relieves pain; it is used to treat cold stagnation of qi, chest discomfort and other symptoms.

[0021] Morinda officinalis: sweet and spicy in taste, slightly warm in nature, enters the kidney and liver meridians, replenishes kidney yang, strengthens muscles and bones, and eliminates rheumatism; used for impotence and spermatorrhea, infertility due to uterine coldness, irregular menstruation, cold pain in the lower abdomen, rheumatic pain, and weakness of muscles and bones.

[0022] The present invention has the effect of treating both the symptoms and the root cause of qi deficiency and blood stasis. The prescription of the present invention is aimed at qi and blood deficiency, poor circulation, and blood stasis. It takes tonifying the spleen and replenishing qi, and promoting blood circulation and removing blood stasis as the basic treatment principles, treating both the symptoms and the root cause. While replenishing qi and nourishing blood, it also promotes blood circulation and removes blood stasis, giving full play to the synergistic effect between the medicinal ingredients. The present invention has a rigorous prescription, precise medication, and strong clinical applicability.

[0023] Compared with the prior art, the present invention has the following advantages:

[0024] The spleen is responsible for "transportation and transformation" and is closely related to the digestive system. Abnormalities in its function and morphology are the most basic pathological changes of spleen deficiency. Serum D-xylose absorption rate is a relatively sensitive and specific detection indicator reflecting digestion and absorption function. Since spleen deficiency cannot transport and transform water and grain, gastrointestinal function is disordered, leading to digestion and absorption dysfunction. After treatment with the Chinese medicine composition of the present invention, the intestinal absorption function of rats with spleen deficiency was promoted and the symptoms of spleen deficiency were improved. The Chinese medicine composition of the present invention increased the D-xylose absorption rate of rats with spleen deficiency model, increased hemoglobin, red blood cell count, plasma total protein and albumin content, and had a positive therapeutic effect on the spleen deficiency model. The Chinese medicine composition of the present invention reduced the hematocrit value, plasma viscosity, and whole blood viscosity value of rats with blood deficiency model, and significantly improved the blood rheology indicators.

[0025] The Chinese medicine composition of the present invention can alleviate the clinical symptoms of patients with chronic fatigue syndrome of qi and blood deficiency type, reduce the symptoms and TCM syndrome scores, and has significant therapeutic effect.

[0026] The invention is a pure traditional Chinese medicine prescription with mild medicinal properties, high safety, good efficacy and is suitable for clinical promotion and application. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1Comparison of D-xylose absorption values ​​in rats of each group

[0028] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05, ## P<0.01.

[0029] Figure 2 Comparison of total protein content in rats of each group

[0030] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05, ## P<0.01.

[0031] Figure 3 Comparison of albumin content in rats of each group

[0032] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05.

[0033] Figure 4 Comparison of red blood cell content in rats of each group

[0034] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05, ## P<0.01.

[0035] Figure 5 Comparison of hemoglobin content in rats of each group

[0036] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05.

[0037] Figure 6 Comparison of hematocrit in rats of each group

[0038] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05.

[0039] Figure 7Comparison of plasma viscosity among rats in each group

[0040] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05.

[0041] Figure 8 Comparison of low shear rate in rats of each group

[0042] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05.

[0043] Figure 9 Comparison of high shear rate in rats of each group

[0044] Compared with the model control group, * P<0.05, ** P<0.01; compared with the Example 1 group, # P<0.05.

[0045] Figure 10 Comparison of symptom and sign scores among the groups

[0046] Compared with the group before treatment, * P<0.05, ** P<0.01; compared with the control group, # P<0.05.

[0047] Figure 11 Comparison of TCM syndrome scores among groups

[0048] Compared with the group before treatment, * P<0.05, ** P<0.01; compared with the control group, # P<0.05. DETAILED DESCRIPTION

[0049] To verify the efficacy of the Chinese medicine composition of the present invention, the inventors conducted pharmacodynamic studies. It should be noted that the drugs selected for the pharmacodynamic studies are drugs obtained from representative formulations and preparation methods of the present invention. Due to space limitations, the tests and results related to other formulations and preparation methods encompassed by the present invention are not exhaustively listed here.

[0050] Example 1 A Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, the formula and preparation method are as follows:

[0051] 15 parts of Codonopsis pilosula, 9 parts of Astragalus membranaceus, 9 parts of Anemarrhena rhizome, 6 parts of Platycodon grandiflorum, 15 parts of Dioscorea opposita, 6 parts of Santalum album and 9 parts of Morinda officinalis.

[0052] The preparation method is as follows:

[0053] Weigh each raw medicinal material, crush it, soak it in water for 1 hour, decoct it twice, add 6 times the amount of water to the total amount of the medicinal material each time, decoct it for 1 hour each time, combine the decoctions, filter, combine the filtrates, and concentrate them to a relative density of 1.10 to obtain an extract.

[0054] Example 2 A Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, the prescription and preparation method are as follows:

[0055] 20 parts of Codonopsis pilosula, 6 parts of Astragalus membranaceus, 12 parts of Anemarrhena asphodeloides, 3 parts of Platycodon grandiflorum, 10 parts of Dioscorea opposita, 3 parts of Santalum album and 12 parts of Morinda officinalis.

[0056] The preparation method is as follows:

[0057] Weigh each raw medicinal material, crush it, soak it in water for 1.5 hours, decoct it twice, add 5 times the amount of water to the total amount of the medicinal material each time, decoct it for 0.5 hours each time, combine the decoctions, filter, combine the filtrates, and concentrate them to a relative density of 1.10 to obtain an extract.

[0058] Example 3 A Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, the formula and preparation method are as follows:

[0059] 10 parts of Codonopsis pilosula, 12 parts of Astragalus membranaceus, 6 parts of Anemarrhena rhizome, 8 parts of Platycodon grandiflorum, 20 parts of Dioscorea opposita, 8 parts of Santalum album and 6 parts of Morinda officinalis.

[0060] The preparation method is as follows:

[0061] Weigh each raw medicinal material, crush it, soak it in water for 2 hours, decoct it twice, add 8 times the amount of water to the total amount of the medicinal material each time, decoct it for 1.5 hours each time, combine the decoctions, filter, combine the filtrates, and concentrate them to a relative density of 1.15 to obtain an extract.

[0062] Example 4 A Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, the prescription and preparation method are as follows:

[0063] 15 parts of Codonopsis pilosula, 12 parts of Astragalus membranaceus, 6 parts of Anemarrhena rhizome, 6 parts of Platycodon grandiflorum, 20 parts of Dioscorea opposita, 6 parts of Santalum album and 10 parts of Morinda officinalis.

[0064] The preparation method is as follows:

[0065] Weigh each raw medicinal material, crush it, soak it in water for 1.5 hours, decoct it twice, add 5 times the amount of water to the total amount of the medicinal material each time, decoct it for 1.2 hours each time, combine the decoctions, filter, combine the filtrates, and concentrate them to a relative density of 1.10 to obtain an extract.

[0066] Example 5 A Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, the formula and preparation method are as follows:

[0067] 10 parts of Codonopsis pilosula, 10 parts of Astragalus membranaceus, 6 parts of Anemarrhena rhizome, 8 parts of Platycodon grandiflorum, 15 parts of Dioscorea opposita, 8 parts of Santalum album and 9 parts of Morinda officinalis.

[0068] The preparation method is as follows:

[0069] Weigh each raw medicinal material, crush it, soak it in water for 2 hours, decoct it twice, add 8 times the amount of water to the total amount of the medicinal material each time, decoct it for 1 hour each time, combine the decoctions, filter, combine the filtrates, and concentrate them to a relative density of 1.15 to obtain an extract.

[0070] Comparative Example 1 A Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, the formula and preparation method are as follows:

[0071] 12 parts of Rhizoma Anemarrhenae, 8 parts of Radix Platycodonis, 20 parts of Rhizoma Dioscoreae, 8 parts of Radix Santalum Albizia and 12 parts of Radix Morindae Officinalis.

[0072] The preparation method is the same as that of Example 1.

[0073] Comparative Example 2 A Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, the formula and preparation method are as follows:

[0074] 20 parts of Codonopsis pilosula, 12 parts of Astragalus membranaceus, 12 parts of Anemarrhena rhizome, 8 parts of Platycodon grandiflorum and 8 parts of Santalum album.

[0075] The preparation method is the same as that of Example 1.

[0076] Comparative Example 3 A Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis, the formula and preparation method are as follows:

[0077] 15 parts of ginseng, 9 parts of atractylodes macrocephala, 9 parts of rhizoma anemarrhenae, 6 parts of platycodon grandiflorum, 15 parts of raw yam, 6 parts of santalinum and 9 parts of morinda officinalis.

[0078] The preparation method is the same as that of Example 1.

[0079] Efficacy Example 1 Experimental Study on the Effect of the Chinese Medicine Composition of the Present Invention on Spleen Qi Deficiency Model

[0080] 1. Establishment of the Spleen Qi Deficiency Rat Model

[0081] 64 SPF male SD rats, weighing 180-200 g, were randomly selected from 8 rats as the blank control group, and the remaining rats were all treated with reserpine to establish the spleen qi deficiency model.

[0082] The modeling method is: use reserpine injection, ventral subcutaneous injection, once a day, 1 mL / time, for 13 consecutive days.

[0083] The rats after modeling were randomly divided into 7 groups, 8 rats in each group, namely model control group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group.

[0084] Group 1 was administered 2.5 g / kg of the extract of Example 1. Group 2 was administered 2.5 g / kg of the extract of Example 2. Group 3 was administered 2.5 g / kg of the extract of Example 3. Group 1 was administered 2.5 g / kg of the extract of Comparative Example 1. Group 2 was administered 2.5 g / kg of the extract of Comparative Example 2. Group 3 was administered 2.5 g / kg of the extract of Comparative Example 3. Each group was administered by gavage.

[0085] Rats in the blank control group and the model control group were gavaged with an equal volume of normal saline at a dose of 10 mL / kg, once a day for 7 consecutive days.

[0086] 2. Index detection

[0087] 2.1 Collect arterial blood in a centrifuge tube and centrifuge at 3500 r / min for 20 min to separate the serum sample. Determine the serum D-xylose absorption rate and calculate the serum D-xylose absorption value.

[0088] 2.2 Determination of red blood cell count, hemoglobin, plasma total protein and albumin content.

[0089] 3. Statistical methods

[0090] SPSS 22.0 software was used for data processing, and the data were expressed as mean ± standard deviation. The data of each group were tested for normal distribution and homogeneity of variance, and the inter-group comparisons were performed using one-way analysis of variance, with P < 0.05 considered the difference statistically significant.

[0091] 4. Experimental Results

[0092] 4.1 Changes in serum D-xylose absorption rate in rats of each group

[0093] Compared with the blank control group, the D-xylose absorption rate of the rats in the model control group was significantly reduced. Compared with the model control group, the D-xylose absorption rate of the rats in Example 1, Example 2, and Example 3 groups was significantly increased. Compared with the comparative examples 1-3 groups, the Example 1 group had a significant difference in increasing the D-xylose absorption rate. Figure 1 .

[0094] 4.2 Comparison of Hemoglobin, Red Blood Cell Count, Plasma Total Protein, and Albumin Content

[0095] Compared with the blank control group, the hemoglobin, red blood cell count, plasma total protein and albumin content of the rats in the model control group were significantly reduced. Compared with the model control group, the hemoglobin, red blood cell count, plasma total protein and albumin content of the rats in Example 1, Example 2 and Example 3 groups were significantly increased.

[0096] Compared with the comparative examples 1-3, the Example 1 group showed significant differences in the increase of hemoglobin, red blood cell count, plasma total protein and albumin content. Figure 2-Figure 5 .

[0097] The spleen governs transportation and transformation and is closely linked to the digestive system. Abnormalities in its function and morphology are the most fundamental pathological changes associated with spleen deficiency. Serum D-xylose absorption rate is a sensitive and specific indicator of digestive and absorptive function. Spleen deficiency prevents the transport and transformation of food and water, leading to gastrointestinal dysfunction and digestive and absorptive dysfunction. Treatment with the Chinese herbal composition of the present invention improved intestinal absorption and alleviated symptoms in rats with spleen deficiency.

[0098] The Chinese medicinal composition of the present invention increases the D-xylose absorption rate of spleen-qi deficiency model rats, increases the hemoglobin, red blood cell count, plasma total protein and albumin content, and has a positive therapeutic effect on the spleen-qi deficiency model.

[0099] Efficacy Example 2 Experimental Study on the Effect of the Chinese Medicine Composition of the Present Invention on Blood Stasis Model

[0100] 1. Establishment of a blood stasis rat model

[0101] 64 SPF grade SD rats, weighing 180-200 g, were randomly selected from 8 rats as a blank control group, and the remaining rats were randomly divided into 7 groups, 8 rats in each group, namely, model control group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group.

[0102] The Example 1 group was given 2.5 g / kg of the extract of Example 1. The Example 2 group was given 2.5 g / kg of the extract of Example 2. The Example 3 group was given 2.5 g / kg of the extract of Example 3. The Comparative Example 1 group was given 2.5 g / kg of the extract of Comparative Example 1. The Comparative Example 2 group was given 2.5 g / kg of the extract of Comparative Example 2. The Comparative Example 3 group was given 2.5 g / kg of the extract of Comparative Example 3. Each group was administered by gavage. Rats in the blank control group and the model control group were gavage-administered with an equal volume of normal saline at a dose of 10 mL / kg, once a day, for 7 consecutive days. On the 7th day, 0.08 mL / 100 g of epinephrine was subcutaneously injected twice, with an interval of 4 hours, and the rats were immersed in ice water for 5 minutes between the two injections.

[0103] 2. Index detection

[0104] After treatment, the patients were not fed and blood was collected 1 hour after administration the next morning to measure hematocrit, whole blood viscosity and plasma viscosity.

[0105] 3. Statistical methods

[0106] SPSS 22.0 software was used for data processing, and the data were expressed as mean ± standard deviation. The data of each group were tested for normal distribution and homogeneity of variance, and the inter-group comparisons were performed using one-way analysis of variance, with P < 0.05 considered the difference statistically significant.

[0107] 4. Experimental Results

[0108] Compared with the blank control group, the whole blood viscosity and plasma viscosity of the rats in the model control group increased, and the hematocrit value increased, indicating that the method has created an acute blood stasis model.

[0109] Compared with the model control group, the hematocrit values ​​of rats in Example 1, Example 2, and Example 3 groups were reduced. Compared with Comparative Examples 1-3 groups, there was a significant difference in reducing the hematocrit value in Example 1 group. Figure 6 .

[0110] Compared with the model control group, the plasma viscosity and whole blood viscosity values ​​of rats in Example 1, Example 2, and Example 3 groups were reduced. Compared with Comparative Examples 1-3 groups, Example 1 group had significant differences in reducing plasma viscosity and whole blood viscosity values. Figure 7-Figure 9 .

[0111] In this experiment, after blood stasis model rats were treated with the Chinese medicine composition of the present invention, the rats' hematocrit values, plasma viscosity, and whole blood viscosity values ​​were significantly reduced, and the blood rheology indicators were significantly improved.

[0112] The Chinese medicine composition of the present invention can alleviate the clinical symptoms of patients with chronic fatigue syndrome of qi and blood deficiency type, reduce the symptoms and TCM syndrome scores, and has significant therapeutic effect.

[0113] Clinical Example Observation on the therapeutic effect of the Chinese medicine composition of the present invention on chronic fatigue syndrome of Qi and blood deficiency type

[0114] 1. Materials and Methods

[0115] 1. Clinical data

[0116] Sixty patients with chronic fatigue syndrome (CHS) due to Qi and blood deficiency were randomly divided into a control group and an experimental group of 30 patients each. The control group consisted of 17 males and 13 females, with a mean age of (45.62±6.21) years; the observation group consisted of 15 males and 15 females, with a mean age of (47.87±7.14) years. The two groups were comparable in age and gender.

[0117] 2. Diagnostic criteria

[0118] Western medicine diagnostic criteria: The criteria, as revised by the U.S. Centers for Disease Control in 1994, include: ① persistent or recurring severe fatigue of unknown clinical cause, lasting for at least six months; ② symptoms not relieved by adequate rest, and activity levels reduced by at least 50% compared to healthy individuals; ③ four or more of the following symptoms, which have persisted for at least six months: decreased short-term memory or concentration; sore throat; swollen and tender lymph nodes in the neck or axilla; muscle pain; non-arthritic joint pain; headache; insomnia or hypersomnia; and fatigue after exercise that persists for more than 24 hours.

[0119] Diagnostic criteria for TCM syndromes: Refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines: Qi Deficiency and Blood Deficiency." The primary symptoms of Qi deficiency syndrome are shortness of breath, fatigue, exhaustion, and a weak pulse; secondary symptoms include spontaneous sweating, laziness, and a pale tongue. A diagnosis is made if two of these primary symptoms and one of these secondary symptoms are present. The primary symptoms of blood deficiency syndrome are pale or sallow complexion, dizziness, and palpitations; secondary symptoms include insomnia, numbness of the hands and feet, delayed menstruation, scanty and pale menstruation, or amenorrhea. A diagnosis is made if two of these primary symptoms and two of these secondary symptoms are present.

[0120] 3. Exclusion criteria

[0121] Those who refuse to participate or fail to take medication as required; pregnant women, women who intend to become pregnant, or breastfeeding women; those with other diseases that can clearly cause fatigue; those with a history of alcoholism, smoking, or drug abuse; those with clear anorexia nervosa or hyperphagia, schizophrenia, paranoia, depression or anxiety, and mental illness; those with decreased short-term memory or poor concentration; those with cardiovascular disease, liver, kidney, lung disease, blood disease, tumor or other metabolic disease; patients with allergic constitution and allergy to multiple drugs.

[0122] 4. Inclusion Criteria

[0123] Diagnosed with chronic fatigue syndrome of Qi and blood deficiency type; aged 18-60 years; voluntarily signed a written consent form.

[0124] 5. Treatment Methods

[0125] Control group: Oral administration of Bazhen Granules, 3.5 g each time, twice a day, for 2 months.

[0126] Observation group: Orally take the decoction prepared in Example 1, 1 dose per day, divided into two doses, for a course of 2 months.

[0127] 6.Indicator observation

[0128] Western medicine symptoms and signs, Chinese medicine syndrome: the main symptoms are scored as 0, 2, 4, and 6 points according to absence, mild, moderate, and severe respectively; the secondary symptoms are scored as 0, 1, 2, and 3 points according to absence, mild, moderate, and severe respectively.

[0129] Clinical cure: After treatment, clinical symptoms and signs disappear or basically disappear, and the total symptom score decreases by no less than 95%; marked effect: clinical symptoms and signs are significantly improved, and the total symptom score decreases by no less than 70%; effective: clinical symptoms and signs are improved, and the total symptom score decreases by no less than 30%; ineffective: those who do not meet the above criteria.

[0130] 7. Statistical Methods

[0131] SPSS 22.0 software was used for data processing, and the data were expressed as mean ± standard deviation. The data of each group were tested for normal distribution and homogeneity of variance, and the inter-group comparisons were performed using one-way analysis of variance, with P < 0.05 considered the difference statistically significant.

[0132] 2. Results

[0133] 1. Efficacy of Western medicine symptoms and signs and TCM symptom scores in the two groups

[0134] After treatment, the Western medicine symptoms and signs, and TCM syndrome scores of the two groups were reduced compared with those before treatment. After treatment, the degree of reduction in Western medicine symptoms and signs, and TCM syndrome scores of the observation group was better than that of the control group. Figure 10 、 Figure 11 .

[0135] 2. Comparison of clinical efficacy between the two groups

[0136] The total effective rate of the observation group was better than that of the control group. The results are shown in Table 1.

[0137] Table 1 Comparison of clinical efficacy between the two groups

[0138]

[0139] The Chinese medicine composition of the present invention can alleviate the clinical symptoms of patients with chronic fatigue syndrome of qi and blood deficiency type, reduce the symptoms and TCM syndrome scores, and has significant therapeutic effect.

[0140] The above embodiments do not limit the present invention in any form. For those skilled in the art, any modifications, replacements, etc. made within the scope of the technical solution of the present invention based on the technical essence of the present invention still fall within the scope of protection of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis, characterized in that: The traditional Chinese medicine composition is prepared from the following components by weight: 10-20 parts of codonopsis pilosula, 6-12 parts of astragalus, 6-12 parts of rhizoma anemarrhenae, 3-8 parts of platycodon, 10-20 parts of raw yam, 3-8 parts of sandalwood and 6-12 parts of morinda officinalis.

2. The Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following components by weight: 15 parts of Codonopsis pilosula, 9 parts of Astragalus membranaceus, 9 parts of Anemarrhena rhizome, 6 parts of Platycodon grandiflorum, 15 parts of Dioscorea opposita, 6 parts of Santalum album and 9 parts of Morinda officinalis.

3. The Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following components by weight: 20 parts of Codonopsis pilosula, 6 parts of Astragalus membranaceus, 12 parts of Anemarrhena rhizome, 3 parts of Platycodon grandiflorum, 10 parts of Dioscorea opposita, 3 parts of Santalum album and 12 parts of Morinda officinalis.

4. The Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following components by weight: 10 parts of Codonopsis pilosula, 12 parts of Astragalus membranaceus, 6 parts of Anemarrhena rhizome, 8 parts of Platycodon grandiflorum, 20 parts of Dioscorea opposita, 8 parts of Santalum album and 6 parts of Morinda officinalis.

5. The method for preparing the Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis according to any one of claims 1 to 4, characterized in that: The preparation method comprises the following steps: weighing each raw medicinal material, crushing it, soaking it in water for 1-2 hours, decocting it twice, adding 5-8 times the total amount of water of the medicinal material each time, decocting it for 0.5-1.5 hours each time, combining the decoctions, filtering, combining the filtrates, and concentrating them to a relative density of 1.10-1.

15.

6. The method for preparing the Chinese medicinal composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis according to claim 5, characterized in that: The preparation method comprises the following steps: weighing each raw medicinal material, crushing it, soaking it in water for 1 hour, decocting it twice, adding 6 times the amount of water of the total amount of the medicinal material each time, decocting it for 1 hour each time, combining the decoctions, filtering, combining the filtrates, and concentrating them to a relative density of 1.

10.

7. Use of the traditional Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis according to any one of claims 1 to 4 in the preparation of a medicine for treating chronic fatigue syndrome and qi and blood deficiency syndrome.

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