Traditional Chinese medicine composition for tonifying qi and spleen and promoting blood circulation to remove blood stasis and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and provides a traditional Chinese medicine composition for tonifying qi and spleen and promoting blood circulation to remove blood stasis and a preparation method thereof.The traditional Chinese medicine composition is prepared from, 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 raw Chinese yam, 3-8 parts of sandalwood and 6-12 parts of morinda officinalis. Aiming at deficiency of qi and blood, dysfunction and blood stasis, the prescription treats both symptoms and root causes according to the basic treatment rules of tonifying spleen and qi and promoting blood circulation to remove blood stasis, promotes blood circulation to remove blood stasis while reinforcing qi and nourishing blood, and gives full play to the synergistic effect of the medicines. The traditional Chinese medicine composition is rigorous in formula, precise and appropriate in medicine use and high in clinical applicability.

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 spleen, promoting blood circulation and removing blood stasis, and a preparation method and application thereof. Background Art

[0002] Qi and blood deficiency refers to qi deficiency and blood deficiency in traditional Chinese medicine. The result of qi and blood deficiency will lead to the decline of organ function, which is manifested as fear of cold, spontaneous sweating, dizziness and tinnitus, fatigue, palpitations, shortness of breath, and developmental delay; blood deficiency causes dull and sallow complexion, dry skin, cracked nails, blurred vision, numbness of hands and feet, insomnia, forgetfulness, palpitations, and mental confusion. Traditional Chinese medicine believes that the main causes of blood deficiency are as follows: some blood deficiency is due to insufficient blood production, qi deficiency cannot produce blood or organ function decline, such as spleen dysfunction, weak stomach qi, unable to transport water and grain essence, and difficult to transform into blood; some blood deficiency is due to excessive and rapid blood loss, and the new blood cannot be replenished in time; some blood deficiency is due to long-term illness, chronic consumption, or excessive mental fatigue, which consumes essence and blood.

[0003] Spleen deficiency syndrome is a group of symptoms that reflect the insufficiency of the spleen's physiological function, similar to the modern medical syndrome of decreased digestive function, impaired nutrient absorption, disordered energy metabolism, decreased disease resistance and weakened functions of various tissues, involving multiple systems and multiple diseases. "The Treatise on Spleen and Stomach" states that "if the spleen and stomach are deficient, the five internal organs, twelve meridians, fifteen collaterals and four limbs will not be able to function and all kinds of diseases will arise", so spleen deficiency syndrome is actually an important pathological basis for many diseases.

[0004] Under the guidance of the Qi and Blood theory of TCM, the two treatment methods of invigorating Qi and replenishing blood are usually inseparable. When Qi is generated, blood can be transformed, and when blood circulates, Qi can be nourished. Drugs with simple ingredients that can replenish Qi and strengthen the spleen and enhance the generation and circulation of Qi and blood 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 invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis. The traditional Chinese medicine composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis is made of the following components by weight: 10-20 parts of Codonopsis pilosula, 6-12 parts of Astragalus, 6-12 parts of Anemarrhena, 3-8 parts of Platycodon, 10-20 parts of raw yam, 3-8 parts of Santalum 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 Dioscorea opposita, 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 Dioscorea opposita, 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 Dioscorea opposita, 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 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 in an amount of 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 Chinese medicine composition for invigorating qi and 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 water 6 times the total amount of the medicinal materials, 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 spleen, promoting blood circulation and removing blood stasis in the preparation of medicines for treating qi and blood deficiency syndrome of chronic fatigue syndrome and qi and blood deficiency caused by long-term overtime work and staying up late.

[0013] The present invention also provides the use of the traditional Chinese medicine composition for invigorating qi and strengthening spleen and 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 fluid; used for spleen and lung qi deficiency, poor appetite and fatigue, cough and weak wheezing, insufficient qi and blood, sallow complexion, palpitations and shortness of breath, thirst due to loss of body fluid, and 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 edema, promotes the production of body fluids 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, long-term diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, qi deficiency and edema, internal heat and thirst, blood deficiency and sallow complexion, hemiplegia, pain and numbness of arthritis, carbuncles that are difficult to heal, and long-term sores that do not heal.

[0017] Anemarrhena: bitter and sweet in taste, cold in nature, enters the lung, stomach and kidney meridians, clears away heat and purges fire, promotes the production of body fluids 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 yam: sweet in taste, neutral in nature, enters the lung, spleen, and kidney meridians; strengthens the spleen, nourishes the lungs, consolidates the kidneys, and benefits the essence. Treats spleen deficiency diarrhea, chronic dysentery, consumptive cough, thirst, spermatorrhea, leucorrhea, and frequent urination. Nourishes the spleen and stomach, promotes fluid production and benefits the lungs, and nourishes the kidneys and astringes the essence. Used for spleen deficiency, poor appetite, chronic diarrhea, asthma and cough due to lung deficiency, spermatorrhea due to kidney deficiency, leucorrhea, frequent urination, and thirst due to deficiency heat.

[0020] Sandalwood: It tastes spicy and is warm in nature. It enters the spleen, stomach, heart, and lung meridians. It can promote the flow of qi and warm the middle, stimulate the appetite and relieve pain. It is used to treat symptoms such as cold stagnation and qi stagnation, and chest discomfort.

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

[0022] The invention has the effect of treating both the symptoms and the root cause of qi deficiency and blood stasis. The prescription of the invention treats qi and blood deficiency, weak circulation and blood stasis, takes tonifying spleen and qi, promoting blood circulation and removing blood stasis as the basic treatment principle, treats both the symptoms and the root cause, promotes blood circulation and removes blood stasis while invigorating qi and nourishing blood, and gives full play to the synergistic effect between the medicinal flavors. The invention has rigorous prescription, proper 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. The abnormality of its function and morphology is the most basic pathological change of spleen deficiency. Serum D-xylose absorption rate is a more sensitive and specific detection index reflecting digestion and absorption function. Since spleen deficiency cannot transport water and grain, gastrointestinal function is disordered, resulting in digestion and absorption dysfunction. After treatment with the Chinese medicine composition of the present invention, the intestinal absorption function of rats with spleen deficiency is promoted and the symptoms of spleen deficiency are improved. The Chinese medicine composition of the present invention increases the D-xylose absorption rate of rats with spleen deficiency model, increases hemoglobin, red blood cell count, plasma total protein and albumin content, and has a positive therapeutic effect on the spleen deficiency model. The Chinese medicine composition of the present invention reduces the hematocrit value, plasma viscosity, and whole blood viscosity value of rats with blood deficiency model, and the blood rheology index is significantly improved.

[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 Chinese medicine prescription with mild medicinal properties, high safety, good curative effect and is suitable for clinical promotion and application. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1Comparison of D-xylose absorption values ​​in rats of different groups

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

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

[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] Fig. 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] Fig.10 Comparison of symptom and sign scores among groups

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

[0047] Fig.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] In order to verify the efficacy of the Chinese medicine composition of the present invention, the inventors conducted a pharmacodynamics test study. It should be noted that the drugs selected for the pharmacodynamics test study of the present invention are drugs obtained by the representative formula of the present invention and its preparation method. Due to space limitations, the tests and results involved in the drugs obtained by other formulas and preparation methods included in the present invention are not listed here one by one.

[0050] Embodiment 1 A Chinese medicine composition for invigorating qi and strengthening 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, 9 parts of Anemarrhena, 6 parts of Platycodon, 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, and boil it twice, with the amount of water added each time being 6 times the total amount of the medicinal material. Boil 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] Embodiment 2 A Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis, the formula and preparation method are as follows:

[0055] 20 parts of Codonopsis pilosula, 6 parts of Astragalus, 12 parts of Anemarrhena, 3 parts of Platycodon, 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, and boil it twice, with the amount of water added each time being 5 times the total amount of the medicinal material. Boil 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] Embodiment 3 A Chinese medicine composition for invigorating qi and strengthening 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, 6 parts of Anemarrhena, 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, and boil it twice, with the amount of water added each time being 8 times the total amount of the medicinal material. Boil 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] Embodiment 4 A Chinese medicine composition for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis, the formula and preparation method are as follows:

[0063] 15 parts of Codonopsis pilosula, 12 parts of Astragalus, 6 parts of Anemarrhena asphodeloides, 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, and boil it twice, with the amount of water added each time being 5 times the total amount of the medicinal material. Boil 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] Embodiment 5 A Chinese medicine composition for invigorating qi and strengthening 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 asphodeloides, 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, and boil it twice, with the amount of water added each time being 8 times the total amount of the medicinal material. Boil 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 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 Example 1.

[0073] Comparative Example 2 A Chinese medicine composition for invigorating qi and strengthening 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 asphodeloides, 8 parts of Platycodon grandiflorum and 8 parts of Santalum album.

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

[0076] Comparative Example 3 A Chinese medicine composition for invigorating qi and strengthening 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 Example 1.

[0079] Efficacy Example 1 Experimental study 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 180-200g, were randomly selected from 8 rats as the blank control group, and the remaining rats were established with the reserpine modeling method to establish the spleen qi deficiency model.

[0082] The modeling method is: use reserpine injection, subcutaneous injection in the ventral side, once a day, 1mL / 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] 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 intragastric gavage.

[0085] Rats in the blank control group and the model control group were intragastrically administered 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 Take arterial blood in a centrifuge tube and centrifuge it at 3500r / min for 20min 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 subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as the difference being statistically significant.

[0091] 4. Experimental Results

[0092] 4.1 Changes in serum D-xylose absorption rate of rats in 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 was significantly increased. Compared with Comparative Examples 1-3, Example 1 had a significant difference in increasing the D-xylose absorption rate. The results are shown in 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 had significant differences in the increase of hemoglobin, red blood cell count, plasma total protein and albumin content. Figure 2-Figure 5 .

[0097] The spleen is responsible for "transportation and transformation" and is closely related to the digestive system. The abnormality of its function and morphology is the most basic pathological change of spleen deficiency. Serum D-xylose absorption rate is a more sensitive and specific detection index reflecting digestion and absorption function. Since spleen deficiency cannot transport water and grain, gastrointestinal dysfunction leads 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 is promoted and the symptoms of spleen deficiency are improved.

[0098] The Chinese medicinal composition of the 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 of the Chinese medicine composition of the present invention on blood stasis model

[0100] 1. Establishment of blood stasis rat model

[0101] 64 SPF SD rats, weighing 180-200 g, were randomly selected from 8 blank control groups, and the remaining rats were divided into 7 groups according to the random number method, 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 gavaged 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] The animals were not fed after treatment, and blood was drawn 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 subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as the difference being 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 had 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 were reduced. Compared with Comparative Examples 1-3, there was a significant difference in reducing the hematocrit value in Example 1. 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 were reduced. Compared with Comparative Examples 1-3, Example 1 showed significant differences in reducing plasma viscosity and whole blood viscosity values. Figure 7-Figure 9 .

[0111] In this experiment, after the blood stasis model rats were treated with the Chinese medicine composition of the present invention, the rats' hematocrit value, plasma viscosity, and whole blood viscosity value were significantly reduced, and the blood rheology indexes 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] The 60 patients with chronic fatigue syndrome of Qi and blood deficiency type who entered this study were randomly divided into a control group and an experimental group of 30 people each. Among them, there were 17 males and 13 females in the control group, with an average age of (45.62±6.21) years old; there were 15 males and 15 females in the observation group, with an average age of (47.87±7.14) years old. The age and gender of the two groups were comparable.

[0117] 2. Diagnostic criteria

[0118] Western medicine diagnostic criteria: in accordance with the diagnostic criteria revised by the US Centers for Disease Control in 1994, ① persistent or recurrent severe fatigue of unknown clinical cause, lasting for no less than 6 months. ② symptoms are not relieved after adequate rest, and activity level is reduced by more than 50% compared with healthy state. ③ 4 or more of the following symptoms, and these symptoms have persisted for no less than 6 months, including short-term memory loss or inattention; sore throat; swollen and tender lymph nodes in the neck or armpits; muscle pain; non-arthritic joint pain; headache; insomnia or drowsiness; fatigue after exercise lasting for more than 24 hours.

[0119] Diagnostic criteria for TCM syndromes: refer to the Guiding Principles for Clinical Research of New Chinese Medicines: Qi Deficiency Syndrome and Blood Deficiency Syndrome. The main symptoms of Qi deficiency syndrome are shortness of breath, fatigue, tiredness, and weak pulse; the secondary symptoms are spontaneous sweating, laziness, and pale tongue. Diagnosis can be made with 2 main symptoms and 1 secondary symptom. The main symptoms of blood deficiency syndrome are pale or sallow complexion, dizziness, and palpitations; the secondary symptoms are insomnia, numbness of hands and feet, delayed menstruation, scanty and pale menstruation, or amenorrhea. Diagnosis can be made with 2 main symptoms and 2 secondary symptoms.

[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 syndrome and mental illness; those with decreased short-term memory or inattention; those with cardiovascular diseases, liver, kidney, lung diseases, blood diseases, tumors or other metabolic diseases; those with allergic constitution and allergies to multiple drugs.

[0122] 4. Inclusion criteria

[0123] Diagnosed with chronic fatigue syndrome of Qi and blood deficiency type; aged 18-60 years old; 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 symptom is recorded as 0, 2, 4, 6 points if it is absent, mild, moderate, or severe respectively; the secondary symptom is recorded as 0, 1, 2, 3 points if it is absent, mild, moderate, or 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 standards.

[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 subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as the difference being statistically significant.

[0132] 2. Results

[0133] 1. The 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 the 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 in the observation group was better than that in the control group. Fig.10 , Fig.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 are not any form of limitation to the present invention. For those skilled in the art, any modification, replacement, etc. made within the scope of the technical solution of the present invention based on the technical essence of the present invention still falls within the protection scope 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 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 Anemarrhena, 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.

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 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 asphodeloides, 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 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 asphodeloides, 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 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 asphodeloides, 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, soaking in water for 1-2 hours, decocting twice, adding water 5-8 times of the total amount of the medicinal material each time, 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.

6. The method for preparing the Chinese medicine composition for invigorating qi and strengthening spleen and 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, soaking in water for 1 hour, decocting twice, adding water 6 times the total amount of the medicinal material each time, decocting for 1 hour each time, combining the decoctions, filtering, combining the filtrates, and concentrating to a relative density of 1.

10.

7. Use of the Chinese medicinal 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 medicaments for invigorating qi and strengthening spleen, promoting blood circulation and removing blood stasis.

8. Use of the Chinese medicinal composition for invigorating qi and strengthening the spleen, promoting blood circulation and removing blood stasis according to any one of claims 1 to 4 in the preparation of medicines for treating qi and blood deficiency syndrome of chronic fatigue syndrome or qi and blood deficiency caused by long-term overtime and staying up late.

9. Use of the Chinese medicinal 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 qi deficiency and blood stasis syndrome in the acute stage of cerebral infarction.

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