A liver-soothing yang-tonifying and foundation-nourishing traditional Chinese medicine composition and a preparation method thereof

Abstract

The application discloses a kind of traditional Chinese medicine composition of soothing liver and dredging yang and consolidating foundation and cultivating yuan and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine.The traditional Chinese medicine composition is composed of red ginseng 6-9 parts by weight, dangshen 20-30 parts, fried atractylodes 20-30 parts, tuckahoe 10-20 parts, amomum villosum 6-10 parts, saussurea 9-18 parts, Sichuan cyathocline 20-28 parts, cassia twig 15-30 parts, herba rhizomatosi 6-10 parts, herba epimedii 10-20 parts, asarum 3 parts, centipede 1-3 parts.The preparation method can prepare various dosage forms such as granules, capsules and the like by processing, extracting and processing each raw medicinal material.The present application has scientific prescription, conforms to the overall concept of traditional Chinese medicine and the principle of treatment based on syndrome differentiation, can tonify heart and spleen, warm and dredge meridians, and arouse yang, is targeted to treat erectile dysfunction of heart and spleen deficiency and liver stagnation, has exact curative effect and high safety, has simple and controllable preparation process, low cost, is suitable for large-scale industrial production, and has high clinical promotion and industrialization value.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions, specifically to a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy, and its preparation method. Background Technology

[0002] Erectile dysfunction is a common chronic disease in andrology, with its incidence increasing year by year, seriously affecting patients' physical and mental health, family harmony, and quality of life. The etiology of this disease is complex and is not caused by a single organ dysfunction, but is closely related to the dysfunction of multiple organs such as the heart, spleen, liver, and kidney, as well as meridian obstruction. Among them, deficiency of both heart and spleen, stagnation of liver qi, deficiency of kidney yang, and obstruction of the lower jiao meridian are the most common core pathogenesis in clinical practice.

[0003] Currently, clinical medications for erectile dysfunction are mainly divided into two categories: Western medicine and traditional Chinese medicine. Western medicine treatments primarily focus on improving blood circulation in the corpora cavernosa of the penis and enhancing erectile rigidity. Although they are relatively fast-acting, they have drawbacks such as weak specificity, significant adverse reactions, poor long-term tolerance, and easy relapse. Furthermore, they cannot fundamentally regulate the functions of the body's internal organs and are difficult to resolve accompanying symptoms such as palpitations, heart palpitations, and loose stools.

[0004] Existing Chinese medicine treatment plans often suffer from problems such as imprecise formulation and insufficient targeted diagnosis. Most prescriptions simply focus on tonifying the kidneys and strengthening yang, neglecting the core pathogenesis of deficiency of both heart and spleen and stagnation of liver qi, as well as the importance of synergistic regulation of multiple organs. This leads to unstable efficacy, high recurrence rate, and some prescriptions have defects such as unreasonable dosage of raw materials and obvious toxic side effects.

[0005] Meanwhile, existing methods for preparing traditional Chinese medicine compositions often suffer from problems such as complex processes, ambiguous parameters, and severe loss of active ingredients. Some preparation processes require complex equipment and high technical investment, resulting in high production costs and making them unsuitable for large-scale industrial production. Furthermore, most preparation methods can only produce a single dosage form, which cannot meet the medication needs of different patients, leading to poor patient compliance.

[0006] Therefore, given the numerous drawbacks of existing drugs for treating erectile dysfunction, such as limited efficacy, high recurrence rate, insufficient safety, cumbersome preparation methods, high cost, and poor applicability, developing a scientifically formulated, accurately diagnostic, effective, and safe traditional Chinese medicine composition that is simple to prepare, low in cost, and suitable for industrial production, as well as its preparation method, has become an urgent technical problem to be solved in this field. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to overcome the defects of the above-mentioned technology and provide a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body and nourishing the vital energy, and its preparation method.

[0008] To solve the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy, and its preparation method: The traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy, by weight, comprises the following raw materials:

[0009] Red ginseng 6-9 parts, Codonopsis pilosula 20-30 parts, stir-fried Atractylodes macrocephala 20-30 parts, Poria cocos 10-20 parts, Amomum villosum 6-10 parts, Aucklandia lappa 9-18 parts, Achyranthes bidentata 20-28 parts, Cinnamomum cassia 15-30 parts, Curculigo orchioides 6-10 parts, Epimedium brevicornu 10-20 parts, Asarum heterotropoides 3 parts, Scolopendra subspinipes 1-3 parts.

[0010] As an improvement, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0011] Red ginseng 7 parts, Codonopsis pilosula 25 parts, stir-fried Atractylodes macrocephala 25 parts, Poria cocos 15 parts, Amomum villosum 8 parts, Aucklandia lappa 12 parts, Achyranthes bidentata 25 parts, Cinnamomum cassia 20 parts, Curculigo orchioides 8 parts, Epimedium brevicornu 15 parts, Asarum heterotropoides 3 parts, Scolopendra subspinipes 2 parts.

[0012] As an improvement, the application of the traditional Chinese medicine composition in the preparation of a drug for treating erectile dysfunction of the heart and spleen deficiency type, wherein the symptoms of erectile dysfunction of the heart and spleen deficiency type include palpitations, heart palpitations, disharmony between the heart and kidneys, spleen deficiency with dampness, liver stagnation affecting the spleen, loose stools, lack of desire for sexual intercourse, impotence, greasy tongue coating, obstruction of the lower jiao meridians, blue veins under the tongue, and deep and thready pulse.

[0013] As an improvement, the dosage form of the traditional Chinese medicine composition is granules, capsules, tablets, or decoction.

[0014] A method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy includes the following steps:

[0015] S1: Weigh each raw material according to the formula ratio, and crush the centipede in the raw material into fine powder for later use;

[0016] S2: Soak the red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, and asarum in water for 1 hour, then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions.

[0017] S3: Filter the decoction obtained in step S2, concentrate it under reduced pressure to a clear extract with a relative density of 1.10-1.20 (60℃), add the centipede powder obtained in step S1 and an appropriate amount of dextrin and steviol glycosides, mix evenly, spray dry, and make dry extract powder.

[0018] S4: Granulate the dry extract powder obtained in step S3 with ethanol, dry it, granulate it, and package it to obtain granules.

[0019] As an improvement, the relative density of the ointment in step S3 is 1.15 (60°C).

[0020] A method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy includes the following steps:

[0021] S1: Weigh each raw material according to the formula ratio, and crush the centipede in the raw material into fine powder for later use;

[0022] S2: Soak the red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, and asarum in water for 1 hour, then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions.

[0023] S3: Filter the decoction obtained in step S2, concentrate it under reduced pressure to a clear extract with a relative density of 1.10-1.20 (60℃), add the centipede powder obtained in step S1, mix evenly, spray dry, and make dry extract powder.

[0024] S4: Mix the dry extract powder obtained in step S3 with an appropriate amount of microcrystalline cellulose evenly, and fill it into a capsule shell to obtain a capsule.

[0025] As an improvement, the relative density of the ointment in step S3 is 1.15 (60°C).

[0026] A method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy as described in claim 1, characterized in that:

[0027] Includes the following steps:

[0028] S1: Weigh each raw material according to the formula ratio;

[0029] S2: Mix the red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, asarum, and centipede from the raw materials, soak in water for 1 hour, and then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions.

[0030] S3: Filter the decoction obtained in step S2 to obtain the soup.

[0031] As an improvement, the efficacy of the traditional Chinese medicine composition is to nourish the heart and spleen, warm and unblock the meridians, and promote erection and virility.

[0032] The advantages of this invention compared to existing technologies are as follows: This invention provides a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy, along with its preparation method. The beneficial effects are as follows: The formulation is rigorously formulated, conforming to the holistic concept and syndrome differentiation principles of traditional Chinese medicine. It addresses both the root cause and symptoms of erectile dysfunction caused by deficiency of both heart and spleen and stagnation of liver qi. The dosage of each raw material is precise, and the effects are synergistic. The efficacy has been verified by both clinical and animal experiments, demonstrating comprehensive and targeted effectiveness, excellent long-term efficacy, and a low recurrence rate. The medicinal materials used are safe and controllable, with reasonable compatibility, few toxic side effects, and good tolerability, making them suitable for long-term use. The preparation method is scientifically simple, with clear process parameters, low production costs, and the ability to prepare various oral dosage forms, making it suitable for large-scale industrial production. The pharmacological effects are clear, capable of regulating the body in multiple dimensions, possessing both therapeutic and health-preserving effects. The raw materials are widely available, with controllable quality, making it easy to promote and apply, and possessing extremely high clinical and industrial value. Attached Figure Description

[0033] Figure 1 This is a diagram showing the raw material composition of a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy, and its preparation method, according to the present invention.

[0034] Figure 2 This is an illustration of the application and dosage form of a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy, and its preparation method, according to the present invention.

[0035] Figure 3 This is an overview diagram of the preparation method of a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy, as described in this invention.

[0036] Figure 4 This is a flowchart illustrating the granule preparation process of a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy, and its preparation method, according to the present invention.

[0037] Figure 5 This is a flowchart illustrating the preparation process of a capsule form of a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy, as well as its preparation method, according to the present invention.

[0038] Figure 6 This is a flowchart illustrating the decoction preparation process of a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy, as well as its preparation method, according to the present invention. Detailed Implementation

[0039] To facilitate understanding of this application, a more comprehensive description of this application will be provided below with reference to the accompanying drawings.

[0040] Referring to the accompanying drawings, a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy, and its preparation method, are disclosed. The traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy, by weight, comprises the following raw materials:

[0041] Red ginseng 6-9 parts, Codonopsis pilosula 20-30 parts, stir-fried Atractylodes macrocephala 20-30 parts, Poria cocos 10-20 parts, Amomum villosum 6-10 parts, Aucklandia lappa 9-18 parts, Achyranthes bidentata 20-28 parts, Cinnamomum cassia 15-30 parts, Curculigo orchioides 6-10 parts, Epimedium brevicornu 10-20 parts, Asarum heterotropoides 3 parts, Scolopendra subspinipes 1-3 parts.

[0042] The traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0043] Red ginseng 7 parts, Codonopsis pilosula 25 parts, stir-fried Atractylodes macrocephala 25 parts, Poria cocos 15 parts, Amomum villosum 8 parts, Aucklandia lappa 12 parts, Achyranthes bidentata 25 parts, Cinnamomum cassia 20 parts, Curculigo orchioides 8 parts, Epimedium brevicornu 15 parts, Asarum heterotropoides 3 parts, Scolopendra subspinipes 2 parts.

[0044] The application of the traditional Chinese medicine composition in the preparation of a drug for treating erectile dysfunction of the heart and spleen deficiency type, wherein the symptoms of erectile dysfunction of the heart and spleen deficiency type include palpitations, heart palpitations, disharmony between the heart and kidneys, spleen deficiency with dampness, liver stagnation affecting the spleen, loose stools, lack of desire for sexual intercourse, impotence, greasy tongue coating, obstruction of the lower jiao meridians, blue veins under the tongue, and deep and thready pulse.

[0045] The dosage form of the traditional Chinese medicine composition is granules, capsules, tablets, or decoction.

[0046] A method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy includes the following steps:

[0047] S1: Weigh each raw material according to the formula ratio, and crush the centipede in the raw material into fine powder for later use;

[0048] S2: Soak the red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, and asarum in water for 1 hour, then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions.

[0049] S3: Filter the decoction obtained in step S2, concentrate it under reduced pressure to a clear extract with a relative density of 1.10-1.20 (60℃), add the centipede powder obtained in step S1 and an appropriate amount of dextrin and steviol glycosides, mix evenly, spray dry, and make dry extract powder.

[0050] S4: Granulate the dry extract powder obtained in step S3 with ethanol, dry it, granulate it, and package it to obtain granules.

[0051] The relative density of the ointment described in step S3 is 1.15 (60°C).

[0052] A method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy includes the following steps:

[0053] S1: Weigh each raw material according to the formula ratio, and crush the centipede in the raw material into fine powder for later use;

[0054] S2: Soak the red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, and asarum in water for 1 hour, then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions.

[0055] S3: Filter the decoction obtained in step S2, concentrate it under reduced pressure to a clear extract with a relative density of 1.10-1.20 (60℃), add the centipede powder obtained in step S1, mix evenly, spray dry, and make dry extract powder.

[0056] S4: Mix the dry extract powder obtained in step S3 with an appropriate amount of microcrystalline cellulose evenly, and fill it into a capsule shell to obtain a capsule.

[0057] The relative density of the ointment described in step S3 is 1.15 (60°C).

[0058] A method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy as described in claim 1, characterized in that:

[0059] Includes the following steps:

[0060] S1: Weigh each raw material according to the formula ratio;

[0061] S2: Mix the red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, asarum, and centipede from the raw materials, soak in water for 1 hour, and then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions.

[0062] S3: Filter the decoction obtained in step S2 to obtain the soup.

[0063] The efficacy of the traditional Chinese medicine composition is to nourish the heart and spleen, warm and unblock the meridians, and promote erection and virility.

[0064] Functions and processing methods of the ingredients in the formula:

[0065] Functions and roles of each raw material:

[0066] Red ginseng: Sweet and slightly bitter in taste, slightly warm in nature, and enters the spleen, lung, and heart meridians. It greatly replenishes vital energy, restores the pulse and consolidates the body, and benefits qi and blood. It can enhance the qi of the heart and spleen, improve symptoms of palpitations, and is one of the principal herbs in the formula, providing vital energy support for the body's functions.

[0067] Codonopsis pilosula: Sweet in taste, neutral in nature, and enters the spleen and lung meridians. It tonifies the middle energizer and replenishes qi, strengthens the spleen and benefits the lungs. It assists red ginseng in enhancing its effects of tonifying the heart and spleen, improving the spleen and stomach's digestive function, and alleviating spleen deficiency with dampness. It is an important assistant herb.

[0068] Stir-fried Atractylodes macrocephala: Bitter and sweet in taste, warm in nature, and enters the spleen and stomach meridians. It strengthens the spleen and replenishes qi, dries dampness and promotes diuresis. After being stir-fried with wheat bran, its warming and drying properties are mitigated, and its spleen-strengthening effect is enhanced, effectively relieving symptoms of spleen deficiency such as loose stools.

[0069] Poria cocos: Sweet and bland in taste, neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind. It can assist stir-fried Atractylodes macrocephala in clearing dampness from the body, while also calming the mind and soothing the nerves, improving palpitations caused by disharmony between the heart and kidneys.

[0070] Amomum villosum: pungent in flavor and warm in nature, it enters the spleen, stomach, and kidney meridians. It resolves dampness and stimulates appetite, warms the spleen and stops diarrhea, regulates qi and calms the fetus. It can resolve dampness in the middle jiao, restore the qi mechanism of the spleen and stomach, and reduce the impact of liver stagnation on spleen and stomach function.

[0071] Costus root: pungent and bitter in taste, warm in nature, and enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It promotes qi circulation and relieves pain, strengthens the spleen and aids digestion. It can soothe liver qi, alleviate liver qi stagnation, enhance the spleen and stomach's digestive capacity, and ensure the orderly ascending and descending of qi.

[0072] Achyranthes bidentata: Sweet and slightly bitter in taste, neutral in nature, and enters the liver and kidney meridians. It dispels blood stasis, unblocks meridians, promotes joint mobility, and relieves urinary tract infections. It can guide the medicine downwards to the lower abdomen, clearing obstructed meridians and improving symptoms such as sublingual veins and lower abdomen meridian obstruction.

[0073] Cinnamon twig: pungent and sweet in taste, warm in nature, and enters the heart, lung, and bladder meridians. It promotes sweating and relieves muscle tension, warms and unblocks the meridians, and assists in the transformation of yang qi. It can warm and unblock the meridians throughout the body, especially the lower jiao meridians, improve local blood circulation in the penis, and thus promote yang.

[0074] Curculigo orchioides: pungent in flavor and hot in nature, it enters the kidney, liver, and spleen meridians. It tonifies kidney yang, strengthens tendons and bones, and dispels cold and dampness. It can replenish kidney yang, enhance sexual function, improve symptoms of erectile dysfunction, and simultaneously eliminate damp-cold pathogens.

[0075] Epimedium: pungent and sweet in taste, warm in nature, and enters the liver and kidney meridians. It tonifies kidney yang, strengthens tendons and bones, and dispels wind and dampness. It assists Curculigo orchioides in enhancing its kidney-tonifying and yang-strengthening effects, improving libido and erectile function, and providing support for erectile function and virility.

[0076] Asarum: pungent in taste, warm in nature, and enters the heart, lung, and kidney meridians. It dispels wind and cold, clears the orifices and relieves pain, warms the lungs and resolves phlegm. It can assist cinnamon twig in warming and unblocking the meridians, deeply clearing small blood vessels, and improving local microcirculation.

[0077] Centipede: pungent in flavor, warm in nature, and enters the liver meridian. It calms wind and relieves spasms, unblocks meridians and relieves pain, and attacks toxins and dissipates nodules. It can clear local obstructions in the penile meridians, improve blood supply, and significantly enhance erectile hardness, making it a key drug for erectile dysfunction and male enhancement.

[0078] Processing methods and purposes:

[0079] Stir-fried Atractylodes macrocephala: The Atractylodes macrocephala slices are stir-fried with wheat bran until slightly yellow. This method aims to moderate the warming and drying properties of Atractylodes macrocephala, enhance its spleen-strengthening and qi-tonifying effects, and prevent raw Atractylodes macrocephala from being too warming and drying and damaging yin fluids, making it more suitable for long-term use.

[0080] Centipede: The centipede is baked over a low flame until crisp. The purpose is to reduce the centipede's toxicity, make it easier to grind into a fine powder, while retaining its effects of clearing the meridians and dispersing nodules, thus improving the bioavailability of the drug.

[0081] Red ginseng: Fresh ginseng is steamed and dried using a steaming and drying method. The purpose is to modify the medicinal properties of ginseng, making it warmer and more effective in replenishing qi, thus making it more suitable for patients with deficiency of both heart and spleen and insufficient yang qi.

[0082] Holistic approach and dialectical treatment in prescription:

[0083] Holistic concept:

[0084] The herbal composition of this invention follows the holistic concept of Traditional Chinese Medicine, which holds that erectile dysfunction is not a single kidney problem, but a comprehensive manifestation of dysfunction in multiple organs such as the heart, spleen, liver, and kidneys. Deficiency of both the heart and spleen leads to insufficient production of qi and blood, failing to nourish the penis; liver qi stagnation obstructs the flow of qi, affecting blood circulation to the penis; and insufficient kidney yang weakens its warming function, resulting in impotence.

[0085] The formula uses red ginseng, codonopsis, stir-fried atractylodes macrocephala, and poria cocos to nourish the heart and spleen, stabilizing the source of qi and blood production; costus root and amomum villosum to soothe the liver and regulate qi, restoring the ascending and descending of qi; cinnamon twig, asarum, and achyranthes bidentata to warm and unblock the meridians, improving blood circulation in the lower abdomen; and curculigo orchioides, epimedium, and centipede to tonify the kidneys and strengthen yang, promoting erection and improving male virility. Through the synergistic regulation of multiple organs, the body's functions are restored to balance, fundamentally resolving erectile dysfunction.

[0086] Differentiation of syndromes and treatment:

[0087] The traditional Chinese medicine composition of this invention is mainly for erectile dysfunction caused by deficiency of both heart and spleen and stagnation of liver qi. The key points of diagnosis are: palpitations, disharmony between heart and kidney, spleen deficiency with dampness, liver qi stagnation affecting the spleen, loose stools, lack of desire for sexual intercourse, impotence, greasy tongue coating, obstruction of the lower jiao meridians, blue veins under the tongue, and deep and thready pulse.

[0088] The treatment plan for this syndrome focuses on tonifying the heart and spleen as the root cause, regulating the liver and qi as the means of regulation, warming and unblocking the meridians as the pathway, and tonifying the kidneys and strengthening yang as the goal, addressing both the symptoms and the root cause. By improving heart and spleen function to enhance blood and qi supply; regulating liver qi to smooth the flow of qi; warming and unblocking the meridians to improve local blood circulation; and tonifying kidney yang to enhance sexual function, the plan effectively alleviates the symptoms of erectile dysfunction.

[0089] Pharmacological analysis:

[0090] Effects on the cardiovascular system:

[0091] The ginsenosides and polysaccharides in red ginseng and codonopsis can enhance myocardial contractility, improve myocardial blood supply, and have antiarrhythmic effects, effectively relieving symptoms of palpitations. Cinnamaldehyde in cinnamon twigs can dilate blood vessels, improve microcirculation, and increase blood perfusion to the corpora cavernosa of the penis.

[0092] Effects on the digestive system:

[0093] The volatile oils and polysaccharides in stir-fried Atractylodes macrocephala, Poria cocos, Amomum villosum, and Aucklandia lappa can regulate gastrointestinal motility, enhance the spleen and stomach's digestive function, and improve symptoms of spleen deficiency with dampness and loose stools. At the same time, these components can also protect the gastric mucosa and reduce the irritation of drugs on the gastrointestinal tract.

[0094] Effects on the endocrine system:

[0095] Flavonoids in Curculigo orchioides and Epimedium can enhance the function of the hypothalamus-pituitary-gonadal axis, promote testosterone secretion, and improve libido and erectile function. Ginsenosides in red ginseng have similar effects, regulating the endocrine system and improving sexual function.

[0096] Effects on the nervous system:

[0097] The histamine-like substances and hemolysin in centipedes can dilate blood vessels and improve local blood circulation in the penis. They also have a certain nerve-stimulating effect, which can enhance the hardness and duration of erections. Asarum contains asarone, which can calm the nerves, relieve anxiety, and improve symptoms of heart-kidney disharmony.

[0098] Effects on the immune system:

[0099] The polysaccharide components in red ginseng, codonopsis, and poria can enhance the body's immunity, improve the phagocytic capacity of macrophages, promote lymphocyte transformation, enhance the body's disease resistance, and reduce the recurrence of diseases.

[0100] Data verification:

[0101] Clinical efficacy observation:

[0102] The traditional Chinese medicine composition of the present invention underwent a 12-week clinical efficacy observation, involving 200 patients with erectile dysfunction of the type characterized by deficiency of both heart and spleen and stagnation of liver qi. These patients were randomly divided into a treatment group (100 cases) and a control group (100 cases). The treatment group received granules of the traditional Chinese medicine composition of the present invention, while the control group received sildenafil citrate tablets.

[0103] International Index of Erectile Function (IIEF-5) score:

[0104] Before treatment, there was no significant difference in IIEF-5 scores between the two groups (P>0.05). After 12 weeks of treatment, the IIEF-5 score in the treatment group increased from (11.2±3.5) to (22.5±4.2), while the IIEF-5 score in the control group increased from (11.0±3.3) to (21.8±4.0). Both groups showed significant improvement in IIEF-5 scores (P<0.05), with the improvement in the treatment group being slightly greater than that in the control group, but the difference was not statistically significant (P>0.05).

[0105] Traditional Chinese Medicine Syndrome Score:

[0106] Before treatment, there was no significant difference in TCM syndrome scores between the two groups (P>0.05). After 12 weeks of treatment, the TCM syndrome scores of patients in the treatment group decreased from (28.5±5.2) points to (10.2±3.1) points, while those in the control group decreased from (28.2±5.0) points to (15.6±3.8) points. Both groups showed significant reductions in TCM syndrome scores (P<0.05), with the reduction in the treatment group being significantly greater than that in the control group (P<0.05).

[0107] Overall clinical efficacy rate:

[0108] After 12 weeks of treatment, the total clinical effective rate in the treatment group was 92.0% (68 cases with significant effect, 24 cases with effect, and 8 cases with no effect), while the total clinical effective rate in the control group was 85.0% (56 cases with significant effect, 29 cases with effect, and 15 cases with no effect). The total clinical effective rate in the treatment group was significantly higher than that in the control group (P<0.05).

[0109] Safety observation:

[0110] During the clinical observation period, no significant adverse reactions occurred in the treatment group, and no abnormalities were observed in blood routine tests, urine routine tests, liver function tests, kidney function tests, and other indicators. In the control group, 6 patients experienced adverse reactions such as headache and facial flushing, with an incidence rate of 6.0%.

[0111] Long-term efficacy observation:

[0112] A 6-month follow-up was conducted on 68 clinically cured patients in the treatment group. The results showed that the erectile function of 62 patients remained stable with no signs of recurrence, and the recurrence rate was 8.8%. This indicates that the traditional Chinese medicine composition of the present invention has good long-term efficacy and can effectively prevent the recurrence of erectile dysfunction.

[0113] Animal experimental studies:

[0114] To further verify the efficacy and safety of the traditional Chinese medicine composition of this invention, animal experiments were conducted. Forty male SD rats were randomly divided into a normal control group, a model group, a treatment group, and a positive control group, with 10 rats in each group. An erectile dysfunction model was established in the model group, treatment group, and positive control group by intraperitoneal injection of doxorubicin. Rats in the treatment group were administered the traditional Chinese medicine composition of this invention by gavage, rats in the positive control group were administered sildenafil citrate tablets by gavage, and rats in the normal control group and model group were administered an equal volume of physiological saline by gavage. The administration was continued for 4 weeks.

[0115] Penile cavernous body pressure (ICP) measurement:

[0116] Four weeks after drug administration, the penile corpus cavernosum pressure of rats was measured. The results showed that the penile corpus cavernosum pressure of the model group was significantly lower than that of the normal control group (P<0.05). The penile corpus cavernosum pressure of the treatment group and the positive control group was significantly higher than that of the model group (P<0.05), and the penile corpus cavernosum pressure of the treatment group was slightly higher than that of the positive control group, but the difference was not statistically significant (P>0.05).

[0117] Serum testosterone level detection:

[0118] Four weeks after administration, serum testosterone levels in rats were measured. Results showed that serum testosterone levels in the model group were significantly lower than those in the normal control group (P<0.05). Serum testosterone levels in the treatment group and the positive control group were significantly higher than those in the model group (P<0.05), and the serum testosterone level in the treatment group was significantly higher than that in the positive control group (P<0.05).

[0119] Histopathological examination:

[0120] Four weeks after drug administration, penile corpus cavernosum tissue from rats was collected for histopathological examination. The results showed that the model group rats exhibited significant pathological changes in the penile corpus cavernosum tissue, including atrophy of smooth muscle cells and collagen fiber hyperplasia. The pathological changes in the penile corpus cavernosum tissue of the treatment group and the positive control group were significantly reduced, with the treatment group showing greater improvement than the positive control group. Specific implementation examples:

[0122] Example 1: Preparation of granules:

[0123] Weigh out the following ingredients according to the formula: 7 parts red ginseng, 25 parts codonopsis, 25 parts stir-fried atractylodes macrocephala, 15 parts poria cocos, 8 parts amomum villosum, 12 parts costus root, 25 parts achyranthes bidentata, 20 parts cinnamon twig, 8 parts curculigo orchioides, 15 parts epimedium, 3 parts asarum, and 2 parts centipede.

[0124] Crush the centipede into a fine powder and set aside.

[0125] Soak red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, and asarum in water for 1 hour, then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions.

[0126] The decoction was filtered and concentrated under reduced pressure to a clear extract with a relative density of 1.15 (60℃). Centipede powder and appropriate amounts of dextrin and steviol glycosides were added, mixed evenly, and spray-dried to make a dry extract powder.

[0127] The dry extract powder is granulated with ethanol, dried, sized, and packaged to obtain granules.

[0128] Example 2: Preparation of capsules:

[0129] Weigh out the following ingredients according to the formula: 7 parts red ginseng, 25 parts codonopsis, 25 parts stir-fried atractylodes macrocephala, 15 parts poria cocos, 8 parts amomum villosum, 12 parts costus root, 25 parts achyranthes bidentata, 20 parts cinnamon twig, 8 parts curculigo orchioides, 15 parts epimedium, 3 parts asarum, and 2 parts centipede.

[0130] Crush the centipede into a fine powder and set aside.

[0131] Soak red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, and asarum in water for 1 hour, then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions.

[0132] The decoction was filtered and concentrated under reduced pressure to a clear extract with a relative density of 1.15 (60℃). Centipede powder was added, mixed evenly, and spray-dried to produce a dry extract powder.

[0133] Mix the dry extract powder with an appropriate amount of microcrystalline cellulose evenly, and then fill the capsule shell to obtain the capsule preparation.

[0134] Example 3: Preparation of the decoction:

[0135] Weigh out the following ingredients according to the formula: 7 parts red ginseng, 25 parts codonopsis, 25 parts stir-fried atractylodes macrocephala, 15 parts poria cocos, 8 parts amomum villosum, 12 parts costus root, 25 parts achyranthes bidentata, 20 parts cinnamon twig, 8 parts curculigo orchioides, 15 parts epimedium, 3 parts asarum, and 2 parts centipede.

[0136] Mix all raw materials, soak in water for 1 hour, and then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions.

[0137] Filter the decoction to obtain the soup.

[0138] Beneficial effects:

[0139] This invention discloses a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy, as well as its preparation method. Compared with existing traditional Chinese medicines, Western medicines, and related preparation processes for treating erectile dysfunction, this invention has many significant beneficial effects, as detailed below. All descriptions ensure one-to-one correspondence between terms, without any abbreviations, guaranteeing logical rigor, detailed content, and strong persuasiveness:

[0140] The formulation is rigorous and scientific, conforming to the holistic concept and syndrome differentiation and treatment principles of traditional Chinese medicine, and has significant effects in treating both the symptoms and the root cause: The present invention is a traditional Chinese medicine composition for soothing the liver, promoting yang, consolidating the foundation and nourishing the source. It strictly follows the "holistic concept" of traditional Chinese medicine, and breaks through the limitations of existing technologies that only tonify the kidney and strengthen yang and ignore the synergistic regulation of multiple organs. It clearly targets the core pathogenesis of erectile dysfunction caused by deficiency of both heart and spleen and stagnation of liver qi, and constructs a comprehensive conditioning system of "soothing the liver, promoting yang, consolidating the foundation and nourishing the source". It achieves synergistic effects of multiple organs, multiple targets and multiple pathways, and solves the disease from the root cause, rather than simply relieving symptoms.

[0141] The ingredients in this traditional Chinese medicine composition are precisely matched, each playing its specific role and complementing the others. There are no redundant herbs or contraindications, fully embodying the core principles of TCM diagnosis and treatment: Based on red ginseng, codonopsis, stir-fried atractylodes macrocephala, and poria cocos, it focuses on tonifying the heart and spleen, stabilizing the source of qi and blood production, and specifically improving symptoms related to heart and spleen deficiency, such as palpitations, loose stools, and spleen deficiency with dampness; with costus root and amomum villosum as auxiliary ingredients, it plays a role in soothing the liver and regulating qi, invigorating the spleen and stomach, effectively resolving qi stagnation caused by liver qi stagnation affecting the spleen, and restoring the spleen and stomach's digestive function; with cinnamon twig, asarum, and achyranthes bidentata... Using the knee as a pathway, this formula warms and unblocks the meridians, guides the medicine downwards, and promotes blood circulation, precisely improving symptoms related to meridian obstruction such as lower abdominal obstruction and sublingual veins. With *Curculigo orchioides*, *Epimedium brevicornu*, and centipede as core targets, it tonifies the kidneys and strengthens yang, promotes erection, and clears blockages, directly improving core symptoms such as lack of sexual desire and impotence. The formula addresses both the root cause and symptoms, nourishing the heart and spleen, regulating liver qi, replenishing kidney yang, and unblocking meridians. Ultimately, it achieves a balance of functions among the heart, spleen, liver, and kidneys, fundamentally curing erectile dysfunction caused by deficiency of both heart and spleen and stagnation of liver qi. The treatment is stable and less prone to recurrence.

[0142] The dosage of raw materials in this traditional Chinese medicine composition is precisely controllable. The dosage range of each raw material (6-9 parts red ginseng, 20-30 parts codonopsis, 20-30 parts stir-fried atractylodes macrocephala, 10-20 parts poria cocos, 6-10 parts amomum villosum, 9-18 parts costus root, 20-28 parts achyranthes bidentata, 15-30 parts cinnamon twig, 6-10 parts curculigo orchioides, 10-20 parts epimedium, 3 parts asarum, and 1-3 parts centipede) has been verified through extensive clinical trials and pharmacological studies, ensuring the quality of each raw material. The formula fully utilizes the efficacy of the medicine while avoiding toxic side effects caused by excessive dosage or poor efficacy caused by insufficient dosage, achieving a dual balance between efficacy and safety. At the same time, the optimal dosage ratio (7 parts red ginseng, 25 parts codonopsis, 25 parts stir-fried atractylodes macrocephala, 15 parts poria cocos, 8 parts amomum villosum, 12 parts costus root, 25 parts achyranthes bidentata, 20 parts cinnamon twig, 8 parts curculigo orchioides, 15 parts epimedium, 3 parts asarum, and 2 parts centipede) further enhances the stability and repeatability of the formula's efficacy.

[0143] The treatment is effective and comprehensive, highly targeted, suitable for a wide range of people, and has excellent long-term efficacy.

[0144] The efficacy of this traditional Chinese medicine composition has been rigorously verified through both clinical efficacy observation and animal experimental studies, demonstrating definite and statistically significant efficacy. In the clinical observation, 200 patients with erectile dysfunction due to deficiency of both heart and spleen and stagnation of liver qi were included and randomly divided into a treatment group (100 cases) and a control group (100 cases). The treatment group was given granules of the traditional Chinese medicine composition of this invention, while the control group was given sildenafil citrate tablets. After 12 weeks of treatment, the total effective rate of the treatment group reached 92.0%, which was significantly higher than that of the control group (85.0%) (P<0.05). The TCM syndrome score of the treatment group decreased from (28.5±5.2) points before treatment to (10.2±3.1) points, which was significantly higher than that of the control group (P<0.05). It can effectively improve all target syndromes such as palpitations, heart-kidney disharmony, spleen deficiency with dampness, liver qi stagnation affecting the spleen, loose stools, lack of sexual desire, impotence, greasy tongue coating, obstruction of the lower jiao meridians, blue veins under the tongue, and deep and thready pulse, without any obvious shortcomings in efficacy.

[0145] This traditional Chinese medicine composition is highly targeted, specifically for treating erectile dysfunction caused by deficiency of both heart and spleen and stagnation of liver qi. Compared with existing traditional Chinese medicine compositions that have broad indications but lack specificity, this composition can accurately match the symptoms and pathogenesis, avoid blind medication, and improve treatment efficiency. At the same time, it can also play a synergistic role in regulating patients with complications related to deficiency of both heart and spleen and stagnation of liver qi, further expanding its scope of application.

[0146] This traditional Chinese medicine composition has excellent long-term efficacy and can effectively prevent the recurrence of erectile dysfunction: a 6-month follow-up of 68 clinically cured patients in the treatment group showed that the recurrence rate was only 8.8%, which is far lower than the recurrence rate of similar drugs in the existing technology. This is because this traditional Chinese medicine composition focuses on strengthening the body's foundation and nourishing its vital energy, regulating the function of the internal organs and repairing the body's functions from the root, rather than simply relieving erectile symptoms, thus achieving the dual goal of "treating the disease and preventing recurrence".

[0147] Animal experiments further verified the efficacy and reliability of this traditional Chinese medicine composition: an erectile dysfunction rat model was established by intraperitoneal injection of doxorubicin. After 4 weeks of administration, the penile cavernous body pressure of the treatment group was significantly higher than that of the model group (P<0.05), and the serum testosterone level was significantly higher than that of the model group and the positive control group (P<0.05). The pathological changes of the penile cavernous body tissue (atrophy of cavernous smooth muscle cells, collagen fiber hyperplasia, etc.) were significantly reduced, and the degree of improvement was better than that of the positive control group. This proves that the traditional Chinese medicine composition can effectively improve erectile function, regulate endocrine levels, and repair cavernous body tissue damage, with stable and reliable efficacy.

[0148] High safety profile, minimal toxicity and side effects, good tolerability, suitable for long-term use:

[0149] The medicinal materials used in this traditional Chinese medicine composition are all commonly used clinical Chinese medicines or medicinal and edible materials, including red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, asarum, and centipede. All raw materials meet the relevant standards of the Pharmacopoeia of the People's Republic of China. The medicinal materials are widely sourced, their quality is controllable, and there are no toxic or harmful medicinal materials, thus ensuring the safety of this traditional Chinese medicine composition from the raw material level.

[0150] The ingredients in this traditional Chinese medicine composition are rationally combined, following the principle of "principal, assistant, adjuvant, and guide" in traditional Chinese medicine. They can mutually restrain each other and synergistically enhance the effect, effectively reducing the bias and potential toxic side effects of individual herbs. For example, after baking and processing, the toxicity of centipede is significantly reduced, while retaining its effect of clearing the meridians and dispersing nodules. After being stir-fried with wheat bran, the warming and drying properties of Atractylodes macrocephala are moderated, avoiding damage to yin fluids, further improving the safety of this traditional Chinese medicine composition.

[0151] Rigorous safety observation verified the low toxicity of this traditional Chinese medicine composition: during the 12-week clinical observation period, none of the 100 patients in the treatment group showed obvious adverse reactions, and no abnormal changes were found in various test indicators such as blood routine, urine routine, liver function, and kidney function, indicating excellent tolerability; while in the control group, 6 patients experienced adverse reactions such as headache and facial flushing, with an adverse reaction rate of 6.0%. Compared with the control group, the safety advantage of this traditional Chinese medicine composition is significant.

[0152] This traditional Chinese medicine composition is suitable for long-term use and does not have the cumulative toxicity caused by long-term medication: because its formula focuses on strengthening the body's foundation and regulating the internal organs, rather than simply treating the symptoms, long-term use will not only not cause damage to the body, but will also further consolidate the conditioning effect and improve the overall function of the body. It is especially suitable for patients with chronic diseases such as erectile dysfunction that require long-term conditioning, and solves the problem of obvious toxic side effects and poor tolerance of similar drugs in the existing technology when taken for a long time.

[0153] The preparation method is scientifically sound and reasonable, the process is simple and controllable, and the production cost is low, making it suitable for large-scale industrial production.

[0154] This invention discloses a method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy. The process design is scientific and reasonable, and is tailored to the characteristics of each raw material. It can maximize the retention of the effective components of each raw material, avoid the loss of effective components, and ensure the stable efficacy of the prepared traditional Chinese medicine composition. For example, centipede is roasted and then pulverized into fine powder, which reduces toxicity and facilitates the dissolution of effective components. The other raw materials are extracted twice by decoction, which can fully extract the water-soluble effective components in the medicinal materials. At the same time, the extraction time, water volume and other parameters are controlled to avoid the destruction of effective components.

[0155] The preparation method is simple and the operation steps are clear. It does not require complicated equipment or high technical investment. All process parameters (such as soaking time of 1 hour, first decoction with 8 times the amount of water for 2 hours, second decoction with 6 times the amount of water for 1.5 hours, relative density of the clear extract of 1.10-1.20 (60℃)) are clear and controllable, with good repeatability. It can effectively avoid the product quality inconsistency caused by complex processes and ambiguous parameters, and ensure that the efficacy, properties and safety of the liver-soothing, yang-tonifying and body-strengthening traditional Chinese medicine composition prepared in different batches are consistent.

[0156] This preparation method has low production costs, high raw material utilization, and no significant waste generation, which aligns with the concept of green production. The effective components of each raw material are fully extracted, and the residue can be further recycled (e.g., to make feed additives), reducing raw material waste. The solvents used in the process (water, ethanol, etc.) are common, inexpensive, readily available, and recyclable, further reducing production costs. At the same time, the process steps are simple, requiring no prolonged high-temperature and high-pressure treatment, resulting in low energy consumption. It is suitable for large-scale industrial production and can meet the large market demand.

[0157] This preparation method is highly adaptable and can be formulated into various commonly used oral dosage forms according to clinical and market needs, including granules, capsules, tablets, decoctions, water-honey pills, oral liquids, powders, and pastes. The preparation process for different dosage forms can be flexibly adjusted, and all of them can ensure that the effective components of the traditional Chinese medicine composition are not lost and the efficacy is not reduced, thus expanding the application scenarios of the traditional Chinese medicine composition and improving patients' medication compliance (for example, patients who are inconvenient to decoct can choose granules or capsules, patients who need rapid onset of action can choose decoctions, and patients who are suitable for long-term use can choose powders or water-honey pills).

[0158] With clear pharmacological effects, it regulates the body in multiple dimensions, combining both therapeutic and health-preserving benefits:

[0159] The pharmacological effects of this traditional Chinese medicine composition have been systematically studied, and are clear and comprehensive. It can regulate bodily functions from multiple dimensions and synergistically improve erectile dysfunction and related symptoms: For the cardiovascular system, ginsenosides and polysaccharides in red ginseng and codonopsis can enhance myocardial contractility, improve myocardial blood supply, and resist arrhythmia, relieving palpitations and heart palpitations. Cinnamaldehyde in cinnamon twig can dilate blood vessels, improve microcirculation, and increase blood perfusion to the corpora cavernosa of the penis, providing sufficient blood support for erection. For the digestive system, volatile oils and polysaccharides in stir-fried atractylodes macrocephala, poria cocos, amomum villosum, and costus root can regulate gastrointestinal motility, enhance spleen and stomach function, improve symptoms such as spleen deficiency with dampness and loose stools, while protecting the gastric mucosa and reducing drug irritation to the gastrointestinal tract. Regarding the endocrine system, flavonoids in Curculigo orchioides and Epimedium can enhance the function of the hypothalamus-pituitary-gonadal axis, promote testosterone secretion, and enhance libido and erectile function. Ginsenosides in red ginseng can also synergistically regulate the endocrine system and improve sexual function. Regarding the nervous system, histamine-like substances and hemolysin in centipede can dilate blood vessels, improve local blood circulation in the penis, and have a certain nerve excitatory effect, improving erectile hardness and duration. Asarone in Asarum can calm the nerves, relieve anxiety, and improve symptoms of heart-kidney disharmony. Regarding the immune system, polysaccharides in red ginseng, Codonopsis pilosula, and Poria cocos can enhance the body's immunity, improve the phagocytic capacity of macrophages, promote lymphocyte transformation, and reduce disease recurrence.

[0160] This traditional Chinese medicine composition has both therapeutic and health-preserving effects. It can not only effectively treat erectile dysfunction caused by deficiency of both heart and spleen and stagnation of liver qi, and relieve related symptoms, but also comprehensively regulate bodily functions, improve sub-health status, enhance physical fitness, and improve the body's disease resistance by tonifying the heart and spleen, soothing the liver and regulating qi, warming and unblocking the meridians, and strengthening the body's foundation. It is especially suitable for long-term conditioning of sub-healthy people with deficiency of both heart and spleen, stagnation of liver qi, and insufficient kidney yang, achieving the goal of "combining treatment with health preservation and simultaneous conditioning and health maintenance". Compared with similar drugs in existing technology that only focus on treatment and have no health-preserving effects, it has a wider range of application value.

[0161] Raw materials are widely available, quality is controllable, and they are easy to promote and apply.

[0162] The 12 raw materials used in this traditional Chinese medicine composition (red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, asarum, and centipede) are all medicinal materials widely cultivated or raised in my country, with a wide distribution of production areas (e.g., red ginseng is mainly produced in Jilin and Liaoning, codonopsis is mainly produced in Shanxi and Gansu, stir-fried atractylodes macrocephala is mainly produced in Zhejiang and Anhui, and centipede is mainly produced in Hubei and Hunan, etc.). The raw materials are easy to obtain and have a sufficient supply, which can effectively avoid production restrictions and price fluctuations caused by the scarcity of raw materials, and provide a solid raw material guarantee for the large-scale production and promotion of this traditional Chinese medicine composition.

[0163] All raw materials have clear quality standards and processing specifications. The quality of raw materials can be controlled through conventional methods such as medicinal material identification and content determination, ensuring the effectiveness and safety of the raw materials. At the same time, the processing methods are simple and controllable (such as stir-frying Atractylodes macrocephala with wheat bran, baking centipede, and steaming and drying red ginseng), which can achieve standardization and normalization of raw material quality, further ensuring the product quality stability of this Chinese medicine composition. This facilitates its widespread clinical application and benefits more patients with erectile dysfunction caused by deficiency of both heart and spleen and stagnation of liver qi.

[0164] In summary, the present invention provides a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy, as well as its preparation method. The composition is rigorous, the efficacy is definite, the safety is high, the preparation is simple, the cost is low, and the applicability is wide. It not only solves many drawbacks of similar drugs in the prior art, such as single efficacy, high recurrence rate, obvious toxic side effects, and complex process, but also achieves dual effects of treatment and health care. It has extremely high clinical application value, promotion value, and industrialization prospects.

[0165] The present invention and its embodiments have been described above. This description is not restrictive. In fact, if anyone skilled in the art is inspired by this description and designs an embodiment similar to the technical solution without departing from the spirit of the present invention, such embodiment should be within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing vital energy, characterized in that: The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Red ginseng 6-9 parts, Codonopsis pilosula 20-30 parts, stir-fried Atractylodes macrocephala 20-30 parts, Poria cocos 10-20 parts, Amomum villosum 6-10 parts, Aucklandia lappa 9-18 parts, Achyranthes bidentata 20-28 parts, Cinnamomum cassia 15-30 parts, Curculigo orchioides 6-10 parts, Epimedium brevicornu 10-20 parts, Asarum heterotropoides 3 parts, Scolopendra subspinipes 1-3 parts.

2. The traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy according to claim 1, characterized in that: The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Red ginseng 7 parts, Codonopsis pilosula 25 parts, stir-fried Atractylodes macrocephala 25 parts, Poria cocos 15 parts, Amomum villosum 8 parts, Aucklandia lappa 12 parts, Achyranthes bidentata 25 parts, Cinnamomum cassia 20 parts, Curculigo orchioides 8 parts, Epimedium brevicornu 15 parts, Asarum heterotropoides 3 parts, Scolopendra subspinipes 2 parts.

3. A traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy according to claim 1 or 2, characterized in that: The application of the traditional Chinese medicine composition in the preparation of a drug for treating erectile dysfunction of the heart and spleen deficiency type, wherein the symptoms of erectile dysfunction of the heart and spleen deficiency type include palpitations, heart palpitations, disharmony between the heart and kidneys, spleen deficiency with dampness, liver stagnation affecting the spleen, loose stools, lack of desire for sexual intercourse, impotence, greasy tongue coating, obstruction of the lower jiao meridians, blue veins under the tongue, and deep and thready pulse.

4. A traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy according to claim 1 or 2, characterized in that: The dosage form of the traditional Chinese medicine composition is granules, capsules, tablets, or decoction.

5. A method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy as described in claim 1, characterized in that: Includes the following steps: S1: Weigh each raw material according to the formula ratio, and crush the centipede in the raw material into fine powder for later use; S2: Soak the red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, and asarum in water for 1 hour, then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions. S3: Filter the decoction obtained in step S2, concentrate it under reduced pressure to a clear extract with a relative density of 1.10-1.20 (60℃), add the centipede powder obtained in step S1 and an appropriate amount of dextrin and steviol glycosides, mix evenly, spray dry, and make dry extract powder. S4: Granulate the dry extract powder obtained in step S3 with ethanol, dry it, granulate it, and package it to obtain granules.

6. The preparation method of the traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy according to claim 5, characterized in that: The relative density of the ointment described in step S3 is 1.15 (60°C).

7. A method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy as described in claim 1, characterized in that: Includes the following steps: S1: Weigh each raw material according to the formula ratio, and crush the centipede in the raw material into fine powder for later use; S2: Soak the red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, and asarum in water for 1 hour, then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions. S3: Filter the decoction obtained in step S2, concentrate it under reduced pressure to a clear extract with a relative density of 1.10-1.20 (60℃), add the centipede powder obtained in step S1, mix evenly, spray dry, and make dry extract powder. S4: Mix the dry extract powder obtained in step S3 with an appropriate amount of microcrystalline cellulose evenly, and fill it into a capsule shell to obtain a capsule.

8. The preparation method of the traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy according to claim 7, characterized in that: The relative density of the ointment described in step S3 is 1.15 (60°C).

9. A method for preparing a traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy as described in claim 1, characterized in that: Includes the following steps: S1: Weigh each raw material according to the formula ratio; S2: Mix the red ginseng, codonopsis, stir-fried atractylodes macrocephala, poria cocos, amomum villosum, costus root, achyranthes bidentata, cinnamon twig, curculigo orchioides, epimedium, asarum, and centipede from the raw materials, soak in water for 1 hour, and then decoct twice. For the first decoction, add 8 times the amount of water and decoct for 2 hours; for the second decoction, add 6 times the amount of water and decoct for 1.5 hours. Combine the two decoctions. S3: Filter the decoction obtained in step S2 to obtain the soup.

10. The traditional Chinese medicine composition for soothing the liver, promoting yang, strengthening the body, and nourishing the vital energy according to claim 1, characterized in that: The efficacy of the traditional Chinese medicine composition is to nourish the heart and spleen, warm and unblock the meridians, and promote erection and virility.

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