Preparation method of composition capable of invigorating spleen, tonifying kidney, calming heart, soothing nerves, promoting blood circulation and removing blood stasis

Abstract

The embodiment of the invention discloses a preparation method of a composition for tonifying spleen and kidney, calming heart and tranquilizing mind and promoting blood circulation to remove blood stasis. Extraction methods of astragalus membranaceus, hippophae rhamnoides, herba epimedii, ginseng, pseudo-ginseng, fructus lycii and schisandra chinensis are deeply studied, and the prepared composition has the effects of invigorating the spleen, tonifying the kidney, calming the heart, tranquilizing the mind and promoting blood circulation to remove blood stasis, and has the effects of treating fatigue, chest distress, palpitation, chest and back stabbing pain, soreness and weakness of waist and knees, dizziness, tinnitus, dysuria, residual urine after urination, dizziness and the like caused by heart qi deficiency or qi deficiency and blood stasis syndromes. The medicine has a good treatment effect on spermatorrhea, premature ejaculation and the like. The preparation method provided by the invention is relatively simple in steps, high in operability and suitable for industrial production, and has a good application prospect.

Description

Technical Field

[0001] The embodiment of the present invention relates to the technical field of preparation of traditional Chinese medicine or health care products, and specifically to a preparation method of a composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis. The composition is suitable for treating fatigue, chest tightness and palpitations, stabbing pain in the chest and back, soreness of the waist and knees, dizziness and tinnitus, dysuria, residual urine, spermatorrhea and premature ejaculation caused by heart qi deficiency or qi deficiency and blood stasis syndrome. Background Art

[0002] The applicant is the patentee of patent number ZL200410062488.7. The prior patent ZL200410062488.7 discloses a composition with the effects of strengthening the body, strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis, which is used to treat prostate hyperplasia, prostatitis, sexual dysfunction, menopausal syndrome, coronary heart disease, cerebral thrombosis, chronic fatigue, neurasthenia, memory loss, senile dementia and diseases caused by low or disordered immune function. The composition is: (1) 0.2g-12g of ginseng, 2g-40g of astragalus, and 1g-20g of tangerine peel. 0.5g-13g of Radix Eryngii, 1g-24g of Fructus Lycii, 0.5g-13g of Herba Epimedii, 0.2g-12g of Radix Notoginseng, 0.2g-8g of Fructus Schisandrae Chinensis, (2) based on formula (1), excluding Fructus Schisandrae Chinensis, (3) based on formula (1), adding Raspberry, (4) based on formula (1), replacing Radix Ginseng with American Ginseng, (5) based on formula (1), replacing Radix Notoginseng with Rhizoma Chuanxiong or Radix Salviae Miltiorrhizae, or (6) based on formula (1), replacing Fructus Lycii with Raspberry. Among them, Example 1 records: extracting the above flavors three times with water, combining the extracts, precipitating with 70% alcohol, filtering, recovering ethanol from the supernatant, and concentrating. Example 2 records: extracting the above flavors three times with 70-75% alcohol, combining the extracts, recovering ethanol, and concentrating. Due to differences in the characteristics of medicinal ingredients, the types and contents of active ingredients in extracts obtained by different extraction methods will vary, which will in turn affect the efficacy of traditional Chinese medicine.

[0003] Health and longevity are what mankind pursues, and quick recovery from chronic diseases is people's wish. Therefore, it is necessary to prepare a high-quality composition of ginseng, astragalus, seabuckthorn, wolfberry, epimedium, Panax notoginseng, and Schisandra chinensis. Summary of the invention

[0004] To this end, the embodiment of the present invention provides a method for preparing a composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis.

[0005] In order to achieve the above purpose, the embodiment of the present invention provides the following technical solutions:

[0006] The present invention provides a method for preparing a composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis, characterized in that the method comprises:

[0007] Take 1g-280g of Astragalus, 1g-280g of Seabuckthorn, and 0.5g-140g of Epimedium, add 10, 8, 8, or 8, 6, 6 times the amount of water, and boil three times for 4, 3, 2, or 3, 2, 1 hours, respectively, combine the decoctions, filter, centrifuge the filtrate n times, filter, and set aside the filtrate;

[0008] Take 0.1g-28g of ginseng, 0.1g-28g of Panax notoginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45%-65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, respectively, combine the extracts, filter, recover ethanol from the filtrate, filter, centrifuge the filtrate n times, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue, boil for 2 to 4 hours, filter, centrifuge the filtrate n times, filter, and set aside the filtrate;

[0009] All the reserve solutions are combined, concentrated under reduced pressure, filtered, centrifuged n times, the filtrate is added with 200ml to 250ml of monosaccharide syrup, water is added to 1000ml, stirred evenly, packaged, sterilized, and the solution is obtained; or the reserve solution can be refined and made into various suitable dosage forms.

[0010] Further, the method comprises:

[0011] Take 1g-280g of Astragalus, 1g-280g of Seabuckthorn, and 0.5g-140g of Epimedium, add 10, 8, 8 or 8, 6, 6 times the amount of water respectively, and boil for three times, respectively for 4, 3, 2 or 3, 2, 1 hours, respectively, combine the decoctions, filter, and concentrate the filtrates under reduced pressure to a relative density of 1.25 to 1.35 (20°C), respectively add 3 to 4 times the amount of ethanol, stir evenly, stand for 20 to 50 hours, filter, recover ethanol from the filtrates, filter, and concentrate the filtrates under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and use the concentrated solutions for later use;

[0012] Take 0.1g-28g of ginseng, 0.1g-28g of Panax notoginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45%-65% ethanol in 8, 6, 6 or 6, 4, 4 times amount respectively, reflux extract three times, each time for 2 to 4 hours, combine the extracts respectively, filter, recover ethanol from the filtrate respectively, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60° C.), and the concentrated solution is set aside; add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20° C.), add 3 to 4 times amount of ethanol respectively, stir well, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate respectively, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60° C.), and the concentrated solution is set aside;

[0013] Combine all the reserve solutions, add appropriate amount of water, refrigerate, filter, add 200ml to 250ml of monosaccharide syrup, add water to 1000ml, stir well, package, sterilize, and obtain the product; or purify the reserve solutions and make them into various suitable dosage forms.

[0014] Further, the method comprises:

[0015] Take 1g-280g of Astragalus, 1g-280g of Seabuckthorn, 0.5g-140g of Epimedium, add 10, 8, 8 or 8, 6, 6 times the amount of water and boil for three times, respectively for 4, 3, 2 or 3, 2, 1 hours, combine the decoctions, filter, centrifuge the filtrate n times, filter, and set aside the filtrate;

[0016] Take 0.1g-28g of ginseng, 0.1g-28g of Panax notoginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45% to 65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol, filter, centrifuge the filtrate n times, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, centrifuge the filtrate n times, filter, and set aside the filtrate;

[0017] All the reserve solutions are combined, concentrated under reduced pressure, filtered, centrifuged n times, the filtrate is added with 200ml to 250ml of monosaccharide syrup, water is added to 1000ml, stirred evenly, packaged, sterilized, and the solution is obtained; or the reserve solution can be refined and made into various suitable dosage forms.

[0018] Further, the method comprises:

[0019] Take 1g-280g of Astragalus, 1g-280g of Seabuckthorn, and 0.5g-140g of Epimedium, add 10, 8, 8, or 8, 6, 6 times the amount of water, and boil for three times, respectively for 4, 3, 3, or 3, 2, 1 hours, combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), cool, add 3 to 4 times the amount of ethanol, stir well, let stand for 20 to 50 hours, filter, and use the filtrate for later use;

[0020] Take 0.1g-28g of ginseng, 0.1g-28g of Panax notoginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45% to 65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, combine the extracts, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), add 3 to 4 times amount of ethanol, stir well, let stand for 20 to 50 hours, filter, and set aside the filtrate;

[0021] Combine all the reserve solutions, mix them evenly, filter them, recover the ethanol until there is no alcohol taste, filter them, and concentrate the filtrate under reduced pressure to a concentrate with a relative density of 1.15 to 1.25 (60°C), add 200ml to 250ml of monosaccharide syrup, add water to 1000ml, stir evenly, package, and sterilize to obtain the product; or purify the reserve solution and make it into various suitable dosage forms.

[0022] Further, the method comprises:

[0023] Take 1g-280g of Astragalus and add 10, 8, 8 or 8, 6, 6 times the amount of water to boil three times, for 4, 3, 2 or 3, 2, 1 hours, respectively, combine the decoctions, filter, centrifuge the filtrate n times, filter, and set aside the filtrate;

[0024] Take 1g-280g of seabuckthorn and 0.5g-140g of epimedium, add 10, 8, 8 or 8, 6, 6 times the amount of water and boil for three times, respectively for 4, 3, 2 or 3, 2, 1 hours, combine the decoctions, filter, centrifuge the filtrate n times, filter, and set aside the filtrate;

[0025] Take 0.1g-28g of Panax notoginseng and add 45% to 65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, reflux and extract three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol from the filtrate, filter, centrifuge the filtrate n times, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, centrifuge the filtrate n times, filter, and set aside the filtrate;

[0026] Take 0.1g-28g of ginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45% to 65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol from the filtrate, filter, centrifuge the filtrate n times, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, centrifuge the filtrate n times, filter, and set aside the filtrate;

[0027] All the reserve solutions are combined, concentrated under reduced pressure, filtered, centrifuged n times, the filtrate is added with 200ml to 250ml of monosaccharide syrup, water is added to 1000ml, stirred evenly, packaged, sterilized, and the solution is obtained; or the reserve solution can be refined and made into various suitable dosage forms.

[0028] Further, the method comprises:

[0029] Take 1g to 280g of Astragalus and add 10, 8, 8 or 8, 6, 6 times the amount of water to boil three times, for 4, 3, 2 or 3, 2, 1 hours, respectively, combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), cool, add 3 to 4 times the amount of ethanol and stir evenly, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and use the concentrated solution for later use;

[0030] Take 1g-280g of seabuckthorn and 0.5g-140g of epimedium, add 10, 8, 8 or 8, 6, 6 times the amount of water and boil for three times, for 4, 3, 2 or 3, 2, 1 hours respectively, combine the decoctions, filter, concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), cool, add 3 to 4 times the amount of ethanol and stir evenly, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and use the concentrated solution for later use;

[0031] Take 0.1g-28g of Panax notoginseng and add 45%-65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, reflux extraction three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and the concentrated solution is reserved, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), add 3 to 4 times amount of ethanol, stir well, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and the concentrated solution is reserved;

[0032] Take 0.1g-28g of ginseng, 0.7g-187g of wolfberry, and 0.2g-47g of schisandra chinensis, add 45%-65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60° C.), and the concentrated solution is reserved, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20° C.), add 3 to 4 times amount of ethanol, stir well, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60° C.), and the concentrated solution is reserved;

[0033] Combine all the concentrated liquids, add appropriate amount of water, refrigerate, filter, add 200ml to 250ml of simple syrup, add water to 1000ml, stir well, package, sterilize, and the product is ready; or refine the concentrated liquid to make various suitable dosage forms.

[0034] Furthermore, 150g-280g of Astragalus, 150g-280g of Seabuckthorn, 75g-140g of Epimedium, 15g-28g of Ginseng, 15g-28g of Panax notoginseng, 100g-187g of Lycium barbarum, and 25g-47g of Schisandra chinensis.

[0035] Further, the method comprises:

[0036] Take 150g of Astragalus, 150g of Seabuckthorn, and 75g of Epimedium, add 8, 6, and 6 times the amount of water, and boil three times for 3, 2, and 1 hours, respectively. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), cool, add 3 times the amount of ethanol, stir well, let stand for 24 hours, filter, and the filtrate is reserved; take 15g of ginseng, 15g of Panax notoginseng, 100g of wolfberry, and 25g of Schisandra chinensis, add 6, 4, and 4 times the amount of 50% ethanol, reflux and extract three times, each time for 3 hours, combine the extracts, filter, and the filtrate Set aside, add 6 times the amount of water to the residue and boil for 3 hours, filter, concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), add 3 times the amount of ethanol, stir well, let stand for 24 hours, filter, combine the filtrate with all the above filtrates, stir well, filter, recover ethanol until there is no alcohol taste, filter, concentrate the filtrate under reduced pressure to a concentrate with a relative density of 1.2 (60°C), add 250ml of monosaccharide syrup, add water to 1000ml, stir well, filter, package and sterilize to obtain; or purify the reserved liquid and make it into various suitable dosage forms.

[0037] Further, the method comprises:

[0038] Take 280g of Astragalus, 280g of Seabuckthorn, and 140g of Epimedium, add 10, 8, and 8 times of water and boil three times for 4, 3, and 2 hours respectively, combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), cool, add 4 times of ethanol and stir well, let stand for 24 hours, filter, and the filtrate is reserved; take 28g of Ginseng, 28g of Panax notoginseng, 187g of Lycium barbarum, and 47g of Schisandra chinensis, add 8, 6, and 6 times of 50% ethanol and reflux and extract three times, each time for 4 hours, combine the extracts, filter, and the filtrate is reserved. Add 8 times the amount of water to the residue and boil for 4 hours, filter, concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), add 4 times the amount of ethanol, stir well, let stand for 48 hours, filter, combine the filtrate with all the above filtrates, stir well, filter, recover ethanol until there is no alcohol taste, filter, concentrate the filtrate under reduced pressure to a concentrate with a relative density of 1.2 (60°C), add water, refrigerate, filter, add 250 ml of monosaccharide syrup, add water to 1000 ml, stir well, filter, package, sterilize, and obtain; or purify the reserved solution and make it into various suitable dosage forms.

[0039] Furthermore, the dosage forms include but are not limited to mixtures, oral liquids, syrups, ointments, liquid drinks, granules, powders, instant preparations, tablets, pills, capsules, and soft capsules.

[0040] The embodiments of the present invention have the following advantages:

[0041] The invention conducts in-depth research on the extraction method of astragalus, seabuckthorn, epimedium, ginseng, notoginseng, wolfberry and schisandra. Specifically, astragalus, seabuckthorn and epimedium are decocted in water alone or in a mixture (all or part of them can be mixed), ginseng, notoginseng, wolfberry and schisandra are refluxed and extracted with ethanol alone or in a mixture (all or part of them can be mixed), and the residue is decocted in water. Further, process parameters such as the amount of extraction solvent added, extraction temperature, extraction time, extraction times and the like are studied. The prepared composition has the effects of strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis. It has good therapeutic effects on fatigue, chest tightness and palpitations, chest and back stabbing pain, soreness of waist and knees, dizziness and tinnitus, dysuria, residual urine after urination, spermatorrhea and premature ejaculation caused by heart qi deficiency or qi deficiency and blood stasis syndrome.

[0042] The preparation method provided by the invention has relatively simple steps, strong operability, is suitable for industrial production, and has good application prospects. DETAILED DESCRIPTION

[0043] The following is a description of the implementation of the present invention by specific embodiments. People familiar with the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0044] Example 1

[0045] This embodiment provides a method for preparing a composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis, comprising:

[0046] Take 100g of Astragalus, 250g of Hippophae rhamnoides and 25g of Epimedium, add 8, 6 and 6 times of water and boil for three times, respectively for 3, 2 and 1 hours, combine the decoctions, filter, concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), cool, add 3 times of ethanol and stir well, let stand for 24 hours, filter and set the filtrate aside;

[0047] Take 10g of ginseng, 5g of Panax notoginseng, 120g of wolfberry, and 40g of Schisandra chinensis, add 6, 4, and 4 times the amount of 50% ethanol, reflux and extract three times, each time for 3 hours, combine the extracts, filter, and set aside the filtrate. Add 6 times the amount of water to the residue and boil for 3 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), add 3 times the amount of ethanol, stir well, let stand for 24 hours, filter, and combine the filtrate with all the above filtrates, stir well, filter, recover ethanol until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrate with a relative density of 1.2 (60°C), add 250ml of monosaccharide syrup, add water to 1000ml, stir well, filter, package, and sterilize.

[0048] Example 2

[0049] This embodiment provides a method for preparing a composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis, comprising:

[0050] Take 150g of Astragalus, 150g of Hippophae rhamnoides and 75g of Epimedium, add 8, 6 and 6 times of water and boil for three times, respectively for 3, 2 and 1 hours, combine the decoctions, filter, concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), cool, add 3 times of ethanol and stir well, let stand for 24 hours, filter and set the filtrate aside;

[0051] Take 15g of ginseng, 15g of Panax notoginseng, 100g of wolfberry, and 25g of Schisandra chinensis, add 6, 4, and 4 times the amount of 50% ethanol, reflux and extract three times, each time for 3 hours, combine the extracts, filter, and set aside the filtrate. Add 6 times the amount of water to the residue and boil for 3 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), add 3 times the amount of ethanol, stir well, let stand for 24 hours, filter, and combine the filtrate with all the above filtrates, stir well, filter, recover ethanol until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrate with a relative density of 1.2 (60°C), add 250ml of monosaccharide syrup, add water to 1000ml, stir well, filter, package, and sterilize.

[0052] Example 3

[0053] This embodiment provides a method for preparing a composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis, comprising:

[0054] Take 280g of Astragalus, 280g of Hippophae rhamnoides and 140g of Epimedium, add 10, 8 and 8 times of water and boil for three times, respectively for 4, 3 and 2 hours, combine the decoctions, filter, concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), cool, add 4 times of ethanol and stir well, let stand for 24 hours, filter and set the filtrate aside;

[0055] Take 28g of ginseng, 28g of Panax notoginseng, 187g of wolfberry, and 47g of Schisandra chinensis, add 8, 6, and 6 times the amount of 50% ethanol, reflux and extract three times, each time for 4 hours, combine the extracts, filter, and set aside the filtrate. Add 8 times the amount of water to the residue and boil for 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), add 4 times the amount of ethanol, stir well, let stand for 48 hours, filter, and combine the filtrate with all the above filtrates, stir well, filter, recover ethanol until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrate with a relative density of 1.2 (60°C), add water, refrigerate, filter, add 250ml of monosaccharide syrup, add water to 1000ml, stir well, filter, package, and sterilize.

[0056] Application Examples

[0057] Human efficacy trials

[0058] 1. Volunteers

[0059] Inclusion criteria: 400 adult patients, aged 18-85 years, who met the TCM syndrome differentiation criteria of spleen and kidney deficiency, restlessness, and blood stasis, with symptoms of chest and back pain, chest tightness, and palpitations. All patients were randomly divided into experimental groups 1-4, with 100 people in each group, and all patients voluntarily signed informed consent. Exclusion criteria: patients with severe heart, liver, kidney and other organ failure; pregnant or lactating women; those who are allergic to the experimental drugs; those who have used drugs that affect the results of this experiment in the past month.

[0060] 2. Test methods

[0061] Patients in groups 1 to 3 of the experiment used the compositions of Examples 1 to 3, respectively;

[0062] Patients in the trial 4 group used the composition of Example 1 in ZL200410062488.7.

[0063] Directions for use: Oral, 20 ml at a time, twice a day, once in the morning and once before bedtime on an empty stomach.

[0064] 3. Observation indicators and efficacy standards

[0065] Spleen-tonifying and kidney-benefiting effects: Observe the improvement of the subjects' appetite, digestive function, fatigue, chest tightness, palpitations, chest and back pain and other symptoms; test blood lipids, blood viscosity, hemoglobin and other indicators; evaluate fatigue and physical recovery.

[0066] Calming and soothing effect: Use Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and other scales to assess sleep quality; use Hamilton Anxiety Rating Scale (HAMA) and Hamilton Depression Rating Scale (HAMD) to assess emotional state; monitor brain waves and analyze sleep structure.

[0067] Effect of promoting blood circulation and removing blood stasis: Detect blood rheology indicators, such as whole blood viscosity, plasma viscosity, red blood cell deformation index, etc.; determine coagulation function indicators, such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), etc.; observe the improvement of symptoms such as skin ecchymosis and limb numbness.

[0068] The efficacy criteria are as follows:

[0069] A reduction of ≥70% in symptom scores after treatment was considered markedly effective, a reduction of 30%-69% was considered effective, and a reduction of <30% was considered ineffective.

[0070] 4. Results

[0071] The results are shown in Table 1 below.

[0072] Table 1

[0073] Group Significant effect / person Effective / person Invalid / person Total Effectiveness Test Group 1 53 37 10 90％ Test Group 2 54 39 7 93％ Experiment 3 groups 56 43 1 99％ Test 4 groups 35 47 18 82％

[0074] The results showed that the total effective rate of patients in groups 1-3 was higher than that in group 4. The above content showed that the composition prepared by the method of the present invention had better therapeutic effects in strengthening the spleen and kidney, calming the mind and promoting blood circulation and removing blood stasis. Among them, the effect of group 3 was the best.

[0075] Typical cases:

[0076] The composition prepared by the method has the effects of strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, promoting blood circulation and removing blood stasis, and is suitable for treating fatigue, chest tightness and palpitations, chest and back pain, soreness of waist and knees, dizziness and tinnitus, urination difficulties, residual urine after urination, spermatorrhea and premature ejaculation, etc. caused by heart qi deficiency or qi deficiency and blood stasis syndrome. Among them, chest tightness and palpitations, chest and back pain are the main symptoms of coronary heart diseases such as myocardial infarction and myocardial ischemia.

[0077] 1. No need for stents for myocardial infarction. Song XX, male, 57 years old. Coronary heart disease (myocardial infarction), diabetes.

[0078] On December 17, 2020, I had a coronary angiography for precordial tightness. The results were: 80% stenosis of the middle segment of LAD (left anterior descending branch), 90% stenosis of the distal segment of LCX (left circumflex branch), 90% stenosis of the proximal segment of PLA (left ventricular posterior branch), 90% stenosis of the proximal segment of PDA (posterior descending branch). Medication: 100 mg of aspirin enteric-coated tablets, 40 mg of pantoprazole sodium enteric-coated capsules, 4 mg of pitavastatin calcium, and bisoprolol fumarate tablets were taken orally once a day. 2.5mg, isosorbide mononitrate sustained-release capsules 50mg, metformin hydrochloride tablets 0.5g, nitroglycerin tablets 0.5mg, taken continuously for half a month without improvement, chest tightness often occurs, the doctor requires the patient to have a stent. Before preparing for the stent, the patient was introduced by a friend and started to take the composition of Example 3 orally in January 2021. During this period, except for taking 0.5g of metformin hydrochloride tablets orally once a day, all the above-mentioned western medicines were discontinued. On November 19, 2021, an enhanced CT examination was performed to evaluate the results of the coronary artery: 37.0 points for the anterior descending branch, 76.2 points for the circumflex branch, 9.9 points for the related branch, and a total score of 122.9 points. There was no stenosis in the left main trunk, calcified plaques in the initial segment of the anterior descending branch, and the stenosis was <50%, calcified plaques in the proximal and middle segments of the anterior descending branch, and the stenosis was about 70%, and there was no plaque or stenosis in the middle and distal segments of the anterior descending branch. The first diagonal branch (left ventricular anterior branch) was slender, without clear stenosis, and the second diagonal branch was well developed. Clear stenosis is seen, the proximal segment of the circumflex artery is blurred, and there is no significance stenosis. The middle segment of the circumflex artery is well developed, and there is no clear stenosis. The distal segment of the circumflex artery has calcified plaques and motion artifacts, and significant stenosis is not excluded. The blunt marginal branch is blurred, the proximal and middle segments of the right coronary artery are well developed, and there is no stenosis. The distal segment of the right coronary artery has calcified and non-calcified plaques, and the stenosis is <50%. The posterior descending branch of the right coronary artery has calcified plaques and motion artifacts, and the posterior branch of the right coronary artery is thin and blurred. After oral administration of the above composition, the vascular stenosis is significantly improved, and the stenosis of the middle segment of the left anterior descending branch is reduced from the original 80% to 70%, the stenosis of the left circumflex branch is reduced from the original 90% to no stenosis, the stenosis of the posterior branch of the left ventricle is reduced from the original 90% to thin without clear stenosis, and the stenosis of the posterior descending branch is reduced from the original 90% to calcified plaques and motion artifacts in the posterior descending branch. Enhanced CT was performed twice, and the evaluation score increased from the original total score of 27.63 points to a total score of 122.9 points. The patient did not undergo stenting.

[0079] 2. Rapid healing of diffuse myocardial infarction. Yang XX, female, 80 years old, had coronary heart disease (diffuse myocardial infarction) and urinary incontinence for more than 30 years. After taking the composition of Example 3 orally for more than 5 months, she went to Beijing 309 Hospital for a check-up. The diffuse myocardial infarction disappeared and the urinary incontinence was also cured.

[0080] 3. Myocardial ischemia improves quickly. Chen XX, male, 50 years old.

[0081] Familial coronary heart disease myocardial ischemia, the patient had long-term cyanosis of lips and frequent discomfort in the precordial area. The patient's mother, brother and sister all died of myocardial ischemia. The patient's lips became rosy after taking the composition of Example 3 orally for 1 week, and after 1 month, he felt comfortable, had increased physical strength and was full of energy.

[0082] Although the present invention has been described in detail above by general description and specific embodiments, it is obvious to those skilled in the art that some modifications or improvements can be made to the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all belong to the scope of protection claimed by the present invention.

Claims

1. A method for preparing a composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis, characterized in that: The method comprises: Take 1g-280g of Astragalus, 1g-280g of Seabuckthorn, and 0.5g-140g of Epimedium, add 10, 8, 8, or 8, 6, 6 times the amount of water, and boil three times for 4, 3, 2, or 3, 2, 1 hours, respectively, combine the decoctions, filter, centrifuge the filtrate n times, filter, and set aside the filtrate; Take 0.1g-28g of ginseng, 0.1g-28g of Panax notoginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45%-65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, respectively, combine the extracts, filter, recover ethanol from the filtrate, filter, centrifuge the filtrate n times, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue, boil for 2 to 4 hours, filter, centrifuge the filtrate n times, filter, and set aside the filtrate; All the reserve solutions are combined, concentrated under reduced pressure, filtered, centrifuged n times, the filtrate is added with 200ml to 250ml of monosaccharide syrup, water is added to 1000ml, stirred evenly, packaged, sterilized, and the solution is obtained; or the reserve solution can be refined and made into various suitable dosage forms.

2. The method for preparing the composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The method comprises: Take 1g-280g of Astragalus, 1g-280g of Seabuckthorn, and 0.5g-140g of Epimedium, add 10, 8, 8 or 8, 6, 6 times the amount of water respectively, and boil for three times, respectively for 4, 3, 2 or 3, 2, 1 hours, respectively, combine the decoctions, filter, and concentrate the filtrates under reduced pressure to a relative density of 1.25 to 1.35 (20°C), respectively add 3 to 4 times the amount of ethanol, stir evenly, stand for 20 to 50 hours, filter, recover ethanol from the filtrates, filter, and concentrate the filtrates under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and use the concentrated solutions for later use; Take 0.1g-28g of ginseng, 0.1g-28g of Panax notoginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45%-65% ethanol in 8, 6, 6 or 6, 4, 4 times amount respectively, reflux extract three times, each time for 2 to 4 hours, combine the extracts respectively, filter, recover ethanol from the filtrate respectively, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60° C.), and the concentrated solution is set aside; add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20° C.), add 3 to 4 times amount of ethanol respectively, stir well, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate respectively, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60° C.), and the concentrated solution is set aside; Combine all the reserve solutions, add appropriate amount of water, refrigerate, filter, add 200ml to 250ml of monosaccharide syrup, add water to 1000ml, stir well, package, sterilize, and obtain the product; or purify the reserve solutions and make them into various suitable dosage forms.

3. The method for preparing the composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The method comprises: Take 1g-280g of Astragalus, 1g-280g of Seabuckthorn, 0.5g-140g of Epimedium, add 10, 8, 8 or 8, 6, 6 times the amount of water and boil for three times, respectively for 4, 3, 2 or 3, 2, 1 hours, combine the decoctions, filter, centrifuge the filtrate n times, filter, and set aside the filtrate; Take 0.1g-28g of ginseng, 0.1g-28g of Panax notoginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45% to 65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol, filter, centrifuge the filtrate n times, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, centrifuge the filtrate n times, filter, and set aside the filtrate; All the reserve solutions are combined, concentrated under reduced pressure, filtered, centrifuged n times, the filtrate is added with 200ml to 250ml of monosaccharide syrup, water is added to 1000ml, stirred evenly, packaged, sterilized, and the solution is obtained; or the reserve solution can be refined and made into various suitable dosage forms.

4. The method for preparing the composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The method comprises: Take 1g-280g of Astragalus, 1g-280g of Seabuckthorn, 0.5g-140g of Epimedium, add 10, 8, 8 or 8, 6, 6 times the amount of water and boil for three times, respectively for 4, 3, 2 or 3, 2, 1 hours, combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), cool, add 3 to 4 times the amount of ethanol, stir well, let stand for 20 to 50 hours, filter, and use the filtrate for later use; Take 0.1g-28g of ginseng, 0.1g-28g of Panax notoginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45% to 65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, combine the extracts, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), add 3 to 4 times amount of ethanol, stir well, let stand for 20 to 50 hours, filter, and set aside the filtrate; Combine all the reserve solutions, mix them evenly, filter them, recover the ethanol until there is no alcohol taste, filter them, and concentrate the filtrate under reduced pressure to a concentrate with a relative density of 1.15 to 1.25 (60°C), add 200ml to 250ml of monosaccharide syrup, add water to 1000ml, stir evenly, package, and sterilize to obtain the product; or purify the reserve solution and make it into various suitable dosage forms.

5. The method for preparing the composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The method comprises: Take 1g-280g of Astragalus and add 10, 8, 8 or 8, 6, 6 times the amount of water to boil three times, for 4, 3, 2 or 3, 2, 1 hours, respectively, combine the decoctions, filter, centrifuge the filtrate n times, filter, and set aside the filtrate; Take 1g-280g of seabuckthorn and 0.5g-140g of epimedium, add 10, 8, 8 or 8, 6, 6 times the amount of water and boil for three times, respectively for 4, 3, 2 or 3, 2, 1 hours, combine the decoctions, filter, centrifuge the filtrate n times, filter, and set aside the filtrate; Take 0.1g-28g of Panax notoginseng and add 45% to 65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, reflux and extract three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol from the filtrate, filter, centrifuge the filtrate n times, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, centrifuge the filtrate n times, filter, and set aside the filtrate; Take 0.1g-28g of ginseng, 0.7g-187g of wolfberry, and 0.2g-47g of Schisandra chinensis, add 45% to 65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol from the filtrate, filter, centrifuge the filtrate n times, filter, and set aside the filtrate, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, centrifuge the filtrate n times, filter, and set aside the filtrate; All the reserve solutions are combined, concentrated under reduced pressure, filtered, centrifuged n times, the filtrate is added with 200ml to 250ml of monosaccharide syrup, water is added to 1000ml, stirred evenly, packaged, sterilized, and the solution is obtained; or the reserve solution can be refined and made into various suitable dosage forms.

6. The method for preparing the composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The method comprises: Take 1g to 280g of Astragalus and add 10, 8, 8 or 8, 6, 6 times the amount of water to boil three times, for 4, 3, 2 or 3, 2, 1 hours, respectively, combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), cool, add 3 to 4 times the amount of ethanol and stir evenly, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and use the concentrated solution for later use; Take 1g-280g of seabuckthorn and 0.5g-140g of epimedium, add 10, 8, 8 or 8, 6, 6 times the amount of water and boil for three times, for 4, 3, 2 or 3, 2, 1 hours respectively, combine the decoctions, filter, concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), cool, add 3 to 4 times the amount of ethanol and stir evenly, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and use the concentrated solution for later use; Take 0.1g-28g of Panax notoginseng and add 45%-65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, reflux extraction three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and the concentrated solution is reserved, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20°C), add 3 to 4 times amount of ethanol, stir well, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60°C), and the concentrated solution is reserved; Take 0.1g-28g of ginseng, 0.7g-187g of wolfberry, and 0.2g-47g of schisandra chinensis, add 45%-65% ethanol in 8, 6, 6 or 6, 4, 4 times amount, and reflux extract three times, each time for 2 to 4 hours, combine the extracts, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60° C.), and the concentrated solution is reserved, add 8 or 6 times amount of water to the residue and boil for 2 to 4 hours, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.25 to 1.35 (20° C.), add 3 to 4 times amount of ethanol, stir well, let stand for 20 to 50 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, filter, and concentrate the filtrate under reduced pressure to a concentrated solution with a relative density of 1.15 to 1.25 (60° C.), and the concentrated solution is reserved; Combine all the concentrated liquids, add appropriate amount of water, refrigerate, filter, add 200ml to 250ml of simple syrup, add water to 1000ml, stir well, package, sterilize, and the product is ready; or refine the concentrated liquid to make various suitable dosage forms.

7. The method for preparing the composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis according to claim 1, characterized in that: Astragalus 150g~280g, sea buckthorn 150g~280g, epimedium 75g~140g, ginseng 15g~28g, Panax notoginseng 15g~28g, wolfberry 100g~187g, Schisandra 25g~47g.

8. The method for preparing the composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The method comprises: Take 150g of Astragalus, 150g of Seabuckthorn, and 75g of Epimedium, add 8, 6, and 6 times the amount of water, and boil three times for 3, 2, and 1 hours, respectively. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), cool, add 3 times the amount of ethanol, stir well, let stand for 24 hours, filter, and the filtrate is reserved; take 15g of ginseng, 15g of Panax notoginseng, 100g of wolfberry, and 25g of Schisandra chinensis, add 6, 4, and 4 times the amount of 50% ethanol, reflux and extract three times, each time for 3 hours, combine the extracts, filter, and the filtrate Set aside, add 6 times the amount of water to the residue and boil for 3 hours, filter, concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), add 3 times the amount of ethanol, stir well, let stand for 24 hours, filter, combine the filtrate with all the above filtrates, stir well, filter, recover ethanol until there is no alcohol taste, filter, concentrate the filtrate under reduced pressure to a concentrate with a relative density of 1.2 (60°C), add 250ml of monosaccharide syrup, add water to 1000ml, stir well, filter, package and sterilize to obtain; or purify the reserved liquid and make it into various suitable dosage forms.

9. The method for preparing the composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis according to claim 1, characterized in that: The method comprises: Take 280g of Astragalus, 280g of Seabuckthorn, and 140g of Epimedium, add 10, 8, and 8 times of water and boil three times for 4, 3, and 2 hours respectively, combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), cool, add 4 times of ethanol and stir well, let stand for 24 hours, filter, and the filtrate is reserved; take 28g of Ginseng, 28g of Panax notoginseng, 187g of Lycium barbarum, and 47g of Schisandra chinensis, add 8, 6, and 6 times of 50% ethanol and reflux and extract three times, each time for 4 hours, combine the extracts, filter, and the filtrate is reserved. Add 8 times the amount of water to the residue and boil for 4 hours, filter, concentrate the filtrate under reduced pressure to a relative density of 1.3 (20°C), add 4 times the amount of ethanol, stir well, let stand for 48 hours, filter, combine the filtrate with all the above filtrates, stir well, filter, recover ethanol until there is no alcohol taste, filter, concentrate the filtrate under reduced pressure to a concentrate with a relative density of 1.2 (60°C), add water, refrigerate, filter, add 250 ml of monosaccharide syrup, add water to 1000 ml, stir well, filter, package, sterilize, and obtain; or purify the reserved solution and make it into various suitable dosage forms.

10. The method for preparing the composition for strengthening the spleen and kidney, calming the mind and tranquilizing the nerves, and promoting blood circulation and removing blood stasis according to any one of claims 1 to 9, characterized in that: The dosage forms include, but are not limited to, mixtures, oral liquids, syrups, ointments, liquid drinks, granules, powders, granules, tablets, pills, capsules, and soft capsules.