A traditional Chinese medicine composition for treating heart and spleen deficiency type erectile dysfunction and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for erectile dysfunction due to deficiency of both heart and spleen, and its application, belonging to the field of traditional Chinese medicine technology. The composition consists of a basic formula and modified formulas. The basic formula includes a spleen-tonifying and qi-boosting group, a heart-nourishing and blood-nourishing group, and a blood-activating and aphrodisiac group. The modified formulas are adjusted according to different concurrent symptoms. It can be prepared into various dosage forms such as decoctions and granules. This traditional Chinese medicine composition precisely addresses the core pathogenesis of erectile dysfunction due to deficiency of both heart and spleen—namely, "insufficient heart blood, deficiency of spleen qi, and malnourishment of the reproductive organs"—achieving spleen-tonifying and heart-nourishing, qi-boosting and blood-nourishing, and blood-activating and aphrodisiac effects, without causing stagnation or greasiness. Clinical trials have demonstrated definite efficacy, high overall effective rate, few adverse reactions, and low long-term recurrence rate. It can comprehensively improve patients' erectile function and accompanying symptoms, and is suitable for preparing drugs to treat erectile dysfunction due to deficiency of both heart and spleen.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions, specifically to a traditional Chinese medicine composition for erectile dysfunction caused by deficiency of both heart and spleen and its application. Background Technology

[0002] Erectile dysfunction due to deficiency of both heart and spleen is a common clinical condition in andrology. Its core pathogenesis is insufficient heart blood and spleen qi deficiency, resulting in insufficient production of qi and blood, and malnourishment of the tendons and ligaments, thus leading to abnormal erectile function. Common clinical symptoms include weak erection, difficulty in achieving or maintaining an erection, or short duration of erection, accompanied by palpitations, insomnia, vivid dreams and easy awakening, fatigue, shortness of breath and reluctance to speak, sallow or pale complexion, poor appetite, abdominal distension, loose stools, forgetfulness and dizziness. The tongue appearance is often pale with a white coating, and the pulse is thready and weak.

[0003] Current clinical treatments have significant limitations: Western medicines often focus on improving local blood circulation to temporarily relieve symptoms. While they are fast-acting, they do not address the core pathogenesis of heart and spleen deficiency. Long-term use can easily lead to drug resistance and is often accompanied by side effects such as dizziness, headaches, and gastrointestinal discomfort, making it difficult to treat both the symptoms and the root cause. Traditional Chinese medicine formulas often focus on simply replenishing qi and blood or warming yang and tonifying the kidneys, often resulting in problems such as insufficient tonification and impaired digestion. They cannot simultaneously address the comprehensive needs of "strengthening the spleen, nourishing the heart, replenishing qi, nourishing blood, and unblocking the meridians," failing to fundamentally resolve the core contradictions of insufficient qi and blood production and abnormal nourishment of the reproductive organs. This leads to poor efficacy, recurring symptoms, and serious impacts on patients' physical and mental health and quality of life. Therefore, developing a Chinese medicine composition that precisely addresses the pathogenesis of erectile dysfunction caused by heart and spleen deficiency, achieving replenishment without stagnation and nourishment without greasiness, while possessing both efficacy and safety, has become an urgent technical challenge in clinical practice. Summary of the Invention

[0004] 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 erectile dysfunction of the type of deficiency of both heart and spleen and its application.

[0005] To solve the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type and its application: a traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type, the traditional Chinese medicine composition is composed of a basic formula and an appropriate supplementary formula, each component being in parts by weight; the basic formula includes a spleen-tonifying and qi-boosting group, a heart-nourishing and blood-nourishing group, and a blood-activating and aphrodisiac group; the spleen-tonifying and qi-boosting group consists of 20-30 parts of Astragalus membranaceus, 6-10 parts of Ginseng, 10-15 parts of Atractylodes macrocephala, and 6-8 parts of Glycyrrhiza uralensis; the heart-nourishing and blood-nourishing group consists of 10-15 parts of Angelica sinensis, 10-15 parts of Longan aril, 12-20 parts of Paeonia lactiflora, and 15-20 parts of Rehmannia glutinosa; the blood-activating and aphrodisiac group consists of 6-10 parts of Ligusticum chuanxiong, 10-15 parts of Salvia miltiorrhiza, 15-20 parts of Epimedium brevicornu, and 10-15 parts of Cuscuta chinensis; the appropriate supplementary formula consists of auxiliary components that are adjusted as needed.

[0006] As an improvement, the modified formula includes at least one of the following: For severe palpitations and insomnia, add 15-20 parts of Ziziphus jujuba seed, 10-15 parts of Platycladus orientalis seed, and 6-8 parts of Polygala tenuifolia; For those with poor appetite, abdominal distension, and loose stools, add 10-15 parts of Poria cocos, 15-20 parts of Dioscorea opposita, and 10-15 parts of stir-fried Dolichos lablab; For those with prominent fatigue, shortness of breath, and reluctance to speak, add 15-20 parts of Codonopsis pilosula and increase the amount of Astragalus membranaceus (processed) to 30-35 parts; For those with weak erections accompanied by soreness and weakness in the lower back and knees, add 10-15 parts of Cornus officinalis, 15-20 parts of Lycium barbarum, and 10-15 parts of Eucommia ulmoides; For those with blood stasis, add 6-10 parts of Prunus persica seed, 6-8 parts of Carthamus tinctorius, and 15-20 parts of Spatholobus suberectus; For those with phlegm-dampness, add 6-10 parts of Citrus reticulata peel, 8-10 parts of Pinellia ternata, and 15-20 parts of Coix lacryma-jobi.

[0007] As an improvement, the dosage form of the traditional Chinese medicine composition is decoction, granules, capsules, tablets or pills.

[0008] A method for preparing a traditional Chinese medicine composition for erectile dysfunction due to deficiency of both heart and spleen, wherein when the dosage form of the traditional Chinese medicine composition is a decoction, the preparation method includes the following steps:

[0009] (1) Raw material pretreatment: Select Chinese medicinal materials that meet the standards of the Pharmacopoeia of the People's Republic of China, remove impurities and mud, wash and dry them for later use;

[0010] (2) Weighing and proportioning: Accurately weigh the basic formula and each component of the required additive or subtractive formula according to the weight proportions described in claim 1 or 2;

[0011] (3) Decoction: Put all the weighed medicinal materials into a decoction container, add drinking water at 8-12 times the total weight of the medicinal materials, soak for 30-60 minutes, bring to a boil over high heat, then simmer over low heat for 20-30 minutes, filter and collect the first decoction.

[0012] (4) Second decoction: Add drinking water at 6-8 times the total weight of the medicinal materials to the dregs, bring to a boil over high heat, then simmer over low heat for 15-20 minutes, filter and collect the second decoction;

[0013] (5) Combine the filtrates: Combine the two decoctions, let them stand for 10-15 minutes to settle, take the supernatant, and concentrate it to contain 1-1.5g of raw herbs per 1ml to obtain the Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type in the form of the decoction.

[0014] As an improvement, when the dosage form of the traditional Chinese medicine composition is granules, the preparation method further includes the following steps:

[0015] (6) Concentration and ointment preparation: The combined filtrate obtained in step (5) is concentrated under reduced pressure to a clear ointment with a relative density of 1.20-1.30 (60℃);

[0016] (7) Granulation: Add an appropriate amount of dextrin to the clear paste, wherein the ratio of the clear paste to dextrin is 1:1-1:2, stir evenly, and make into a soft material;

[0017] (8) Drying and granulation: The soft material is granulated through a 16-20 mesh sieve and dried in a drying oven at 60-80℃ until the moisture content is ≤5%. After the dried granules are cooled, they are granulated through a 12-14 mesh sieve to obtain the Chinese medicine composition in granule form for erectile dysfunction of the heart and spleen deficiency type.

[0018] As an improvement, the traditional Chinese medicine composition in granule form for erectile dysfunction due to deficiency of both heart and spleen can be packaged in 5g or 10g packets.

[0019] Application of a traditional Chinese medicine composition for treating erectile dysfunction due to deficiency of both heart and spleen in the preparation of a drug for treating erectile dysfunction due to deficiency of both heart and spleen.

[0020] As an improvement, the clinical manifestations of erectile dysfunction of the heart and spleen deficiency type are weak erection, difficulty in achieving an erection, short duration of erection, accompanied by palpitations, insomnia, fatigue, sallow complexion, poor appetite, loose stools, pale tongue with white coating, and weak pulse.

[0021] As an improvement, the administration method of the medicine is as follows: If it is a decoction of traditional Chinese medicine for erectile dysfunction due to deficiency of both heart and spleen, take it orally, one dose per day, divided into two warm doses, morning and evening, 200-300ml each time; if it is a granule of traditional Chinese medicine for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 1-2 times per day, one packet each time, dissolved in warm water; if it is a capsule of traditional Chinese medicine for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 3-4 capsules each time, 3 times per day, each capsule containing 0.5g of raw herbs; if it is a tablet of traditional Chinese medicine for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 2-3 tablets each time, 3 times per day, each tablet containing 1g of raw herbs; if it is a pill of traditional Chinese medicine for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 6-9g each time, twice per day, taken with warm water.

[0022] As an improvement, the drug is suitable for patients who meet the diagnostic criteria for erectile dysfunction of the heart and spleen deficiency type.

[0023] The advantages of this invention compared to existing technologies are as follows: This traditional Chinese medicine composition precisely addresses the core pathogenesis of erectile dysfunction due to deficiency of both heart and spleen, namely "insufficient heart blood, deficiency of spleen qi, and malnourishment of the reproductive organs." It adopts the treatment principle of "strengthening the spleen and nourishing the heart, replenishing qi and nourishing blood, and unblocking the meridians to treat impotence," with a scientifically rigorous formulation. The combination of the basic formula and modified formulas ensures both the regulation of the core pathogenesis and flexible adjustment for various concurrent symptoms, achieving personalized treatment and adapting to diverse clinical scenarios.

[0024] It nourishes without causing stagnation and moisturizes without being greasy. All raw materials used are commonly used Chinese medicinal herbs listed in the pharmacopoeia. After standardized processing, the medicinal properties are mild, with a low incidence of adverse reactions. No abnormalities were observed in any bodily indicators before and after treatment, making it suitable for long-term conditioning. Clinical trials have demonstrated a high overall effectiveness rate, not only significantly improving erectile function but also comprehensively alleviating accompanying symptoms such as palpitations, insomnia, and fatigue, thus improving the patient's overall health.

[0025] Meanwhile, the long-term efficacy is stable, the recurrence rate is much lower than that of conventional Western medicines, and the dosage forms are diverse and convenient, which can meet the needs of different patients, improve medication adherence, solve the disease from the root, and provide patients with lasting health protection. Attached Figure Description

[0026] Figure 1 This is a structural diagram of a traditional Chinese medicine composition for erectile dysfunction caused by deficiency of both heart and spleen, and its application, according to the present invention.

[0027] Figure 2 This is a diagram illustrating the dosage form and preparation method of a traditional Chinese medicine composition for erectile dysfunction caused by deficiency of both heart and spleen, and its application, according to the present invention.

[0028] Figure 3 This is a diagram illustrating the application and administration of a traditional Chinese medicine composition for erectile dysfunction caused by deficiency of both heart and spleen, as described in this invention. Detailed Implementation

[0029] To facilitate understanding of this application, a more comprehensive description of this application will be provided below with reference to the accompanying drawings.

[0030] Referring to the accompanying drawings, a traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type and its application are disclosed. The traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type comprises a basic formula and an appropriate supplementary formula, with each component in parts by weight. The basic formula includes a spleen-tonifying and qi-boosting group, a heart-nourishing and blood-nourishing group, and a blood-activating and aphrodisiac group. The spleen-tonifying and qi-boosting group consists of 20-30 parts Astragalus membranaceus, 6-10 parts Ginseng, 10-15 parts Atractylodes macrocephala, and 6-8 parts Glycyrrhiza uralensis (processed). The heart-nourishing and blood-nourishing group consists of 10-15 parts Angelica sinensis, 10-15 parts Longan aril, 12-20 parts Paeonia lactiflora, and 15-20 parts Rehmannia glutinosa (processed). The blood-activating and aphrodisiac group consists of 6-10 parts Ligusticum chuanxiong, 10-15 parts Salvia miltiorrhiza, 15-20 parts Epimedium, and 10-15 parts Cuscuta chinensis. The appropriate supplementary formula consists of auxiliary components adjusted as needed.

[0031] The modified formula includes at least one of the following: For severe palpitations and insomnia, add 15-20 parts of Ziziphus jujuba seed, 10-15 parts of Platycladus orientalis seed, and 6-8 parts of Polygala tenuifolia; For those with poor appetite, abdominal distension, and loose stools, add 10-15 parts of Poria cocos, 15-20 parts of Dioscorea opposita, and 10-15 parts of stir-fried Dolichos lablab; For those with prominent fatigue, shortness of breath, and reluctance to speak, add 15-20 parts of Codonopsis pilosula and increase the amount of Astragalus membranaceus (processed) to 30-35 parts; For those with weak erections accompanied by soreness and weakness in the lower back and knees, add 10-15 parts of Cornus officinalis, 15-20 parts of Lycium barbarum, and 10-15 parts of Eucommia ulmoides; For those with blood stasis, add 6-10 parts of Prunus persica seed, 6-8 parts of Carthamus tinctorius, and 15-20 parts of Spatholobus suberectus; For those with phlegm-dampness, add 6-10 parts of Citrus reticulata peel, 8-10 parts of Pinellia ternata, and 15-20 parts of Coix lacryma-jobi.

[0032] The dosage form of the traditional Chinese medicine composition is decoction, granules, capsules, tablets or pills.

[0033] A method for preparing a traditional Chinese medicine composition for erectile dysfunction due to deficiency of both heart and spleen, wherein when the dosage form of the traditional Chinese medicine composition is a decoction, the preparation method includes the following steps:

[0034] (1) Raw material pretreatment: Select Chinese medicinal materials that meet the standards of the Pharmacopoeia of the People's Republic of China, remove impurities and mud, wash and dry them for later use;

[0035] (2) Weighing and proportioning: Accurately weigh the basic formula and each component of the required additive or subtractive formula according to the weight proportions described in claim 1 or 2;

[0036] (3) Decoction: Put all the weighed medicinal materials into a decoction container, add drinking water at 8-12 times the total weight of the medicinal materials, soak for 30-60 minutes, bring to a boil over high heat, then simmer over low heat for 20-30 minutes, filter and collect the first decoction.

[0037] (4) Second decoction: Add drinking water at 6-8 times the total weight of the medicinal materials to the dregs, bring to a boil over high heat, then simmer over low heat for 15-20 minutes, filter and collect the second decoction;

[0038] (5) Combine the filtrates: Combine the two decoctions, let them stand for 10-15 minutes to settle, take the supernatant, and concentrate it to contain 1-1.5g of raw herbs per 1ml to obtain the Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type in the form of the decoction.

[0039] When the dosage form of the traditional Chinese medicine composition is granules, the preparation method further includes the following steps:

[0040] (6) Concentration and ointment preparation: The combined filtrate obtained in step (5) is concentrated under reduced pressure to a clear ointment with a relative density of 1.20-1.30 (60℃);

[0041] (7) Granulation: Add an appropriate amount of dextrin to the clear paste, wherein the ratio of the clear paste to dextrin is 1:1-1:2, stir evenly, and make into a soft material;

[0042] (8) Drying and granulation: The soft material is granulated through a 16-20 mesh sieve and dried in a drying oven at 60-80℃ until the moisture content is ≤5%. After the dried granules are cooled, they are granulated through a 12-14 mesh sieve to obtain the Chinese medicine composition in granule form for erectile dysfunction of the heart and spleen deficiency type.

[0043] The traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type in granule form can be packaged in 5g or 10g bags.

[0044] Application of a traditional Chinese medicine composition for treating erectile dysfunction due to deficiency of both heart and spleen in the preparation of a drug for treating erectile dysfunction due to deficiency of both heart and spleen.

[0045] The clinical manifestations of erectile dysfunction due to deficiency of both heart and spleen include weak erection, difficulty in achieving an erection, short duration of erection, accompanied by palpitations, insomnia, fatigue, sallow complexion, poor appetite, loose stools, pale tongue with white coating, and weak pulse.

[0046] The administration methods of the medicine are as follows: If it is a decoction for erectile dysfunction due to deficiency of both heart and spleen, take it orally, one dose per day, divided into two warm doses, morning and evening, 200-300ml each time; if it is a granule for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 1-2 times per day, one packet each time, dissolved in warm water; if it is a capsule for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 3-4 capsules each time, 3 times per day, each capsule containing 0.5g of raw herbs; if it is a tablet for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 2-3 tablets each time, 3 times per day, each tablet containing 1g of raw herbs; if it is a pill for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 6-9g each time, twice per day, taken with warm water.

[0047] The drug is suitable for patients who meet the diagnostic criteria for erectile dysfunction due to deficiency of both heart and spleen.

[0048] Functions, processing methods, and purposes of raw materials:

[0049] The traditional Chinese medicine composition for erectile dysfunction due to deficiency of both heart and spleen described in this invention comprises a basic formula consisting of a spleen-tonifying and qi-boosting group, a heart-nourishing and blood-nourishing group, and a blood-activating and aphrodisiac group. Adjustments are made to suit different concurrent symptoms. All raw materials are strictly screened according to the standards of the Pharmacopoeia of the People's Republic of China. Its functions, processing methods, and processing purposes are as follows:

[0050] Basic formula ingredients:

[0051] Spleen-strengthening and Qi-tonifying group:

[0052] Astragalus: Sweet in taste and slightly warm in nature, it enters the spleen and lung meridians. Its core functions are to replenish qi and raise yang, generate fluids and nourish blood, and promote circulation and relieve stagnation. It is the chief herb for strengthening the spleen and replenishing qi, enhancing the spleen and stomach's digestive function, promoting the generation of qi and blood, and providing essential material support for nourishing the tendons and ligaments. The processing method is honey-frying. Take clean astragalus slices, add 25%-30% of their weight in refined honey, mix well and let it sit until thoroughly cooked. Stir-fry over low heat until the surface turns a dark yellow and is no longer sticky, then let it cool. This processing method can mitigate the drying and dispersing nature of raw astragalus, focusing on enhancing its effects of replenishing qi and nourishing blood and generating fluids. It precisely addresses the pathogenesis of erectile dysfunction with "qi deficiency and blood deficiency" in the type of heart and spleen deficiency, avoiding the depletion of yin and blood when used raw.

[0053] Ginseng: Sweet and slightly bitter in taste, slightly warm in nature, it enters the spleen, lung, and heart meridians. It has the effects of greatly replenishing vital energy, invigorating the spleen and qi, promoting body fluid production, and calming the mind. It assists astragalus in enhancing the qi-tonifying effect, while also nourishing the heart and calming the mind, improving accompanying symptoms such as fatigue, palpitations, and insomnia. The processing method involves steaming followed by slicing. Cleaned ginseng is washed and thoroughly moistened, then steamed over high heat for 2-3 hours until thoroughly cooked. After slightly cooling, it is sliced ​​thinly and dried. Steaming makes the medicinal properties of ginseng more mild, replenishing qi without causing dryness. Its effective component, ginsenosides, is more easily absorbed by the body, and its heart-nourishing and mind-calming effects are enhanced, making it suitable for the pathogenesis of deficiency of both heart and spleen, and malnourishment of the heart and mind.

[0054] Atractylodes macrocephala: Sweet and bitter in taste, warm in nature, and enters the spleen and stomach meridians. It can invigorate the spleen and replenish qi, dry dampness and promote diuresis, enhance the spleen and stomach's digestive function, reduce internal retention of dampness, and improve symptoms of spleen deficiency such as poor appetite, abdominal distension, and loose stools, thus clearing obstacles for the production of qi and blood. The processing method involves stir-frying with soil. Take 20%-25% of the weight of the Atractylodes macrocephala slices of finely powdered hearth soil, stir-fry over medium heat until it becomes flexible, then add the cleaned Atractylodes macrocephala slices and stir-fry until the surface is coated with soil color and the inside is light yellow. Sift out excess hearth soil and let cool. Stir-frying with soil significantly enhances the spleen-invigorating and dampness-drying effects of Atractylodes macrocephala, further strengthening the spleen-invigorating and spleen-strengthening effects of hearth soil, while also mitigating the drying properties of raw Atractylodes macrocephala and preventing depletion of yin fluids.

[0055] Prepared licorice root: sweet in taste and neutral in nature, it enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying qi and strengthening the middle jiao, and harmonizing the effects of other herbs. It can assist in strengthening the spleen and tonifying qi, and also moderate the drying nature of the qi-tonifying herbs and the strong nature of the blood-activating herbs in the formula, making the overall formula more balanced. The preparation method is honey-processing. Take clean licorice root slices, add 20%-25% of their weight of refined honey, mix well and let it sit thoroughly. Stir-fry over low heat until the surface turns a dark yellow, slightly glossy, and no longer sticky, then let it cool. After honey-processing, its effects of tonifying qi and strengthening the middle jiao, and harmonizing the effects of other herbs are significantly enhanced. Its medicinal properties are mild, perfectly matching the formula's principle of "tonifying without stagnation."

[0056] Heart-Nourishing and Blood-Nourishing Group:

[0057] Angelica sinensis: sweet and pungent in taste, warm in nature, and enters the liver, heart, and spleen meridians. It is an essential herb for nourishing blood, possessing the functions of replenishing and invigorating blood, regulating menstruation, and relieving pain. It can replenish heart blood, invigorate blood circulation, and ensure sufficient and smooth flow of qi and blood, providing a guarantee for nourishing the tendons and ligaments. The processing method involves wine-processing: taking clean angelica sinensis slices, adding 10%-15% of its weight in rice wine, mixing well, and letting it steep thoroughly. Stir-fry over low heat until slightly yellow and with a slight aroma of wine, then let it cool. Wine-processing enhances the blood-invigorating effect of angelica sinensis, promotes the dissolution of active ingredients, and better exerts its effects of "replenishing and invigorating blood, clearing the meridians, and relieving impotence," avoiding the qi and blood stagnation caused by simply replenishing blood.

[0058] Longan pulp: Sweet in taste and warm in nature, it enters the heart and spleen meridians. It nourishes the heart and spleen, replenishes blood, and calms the mind. It can directly replenish heart blood and stabilize the mind, specifically improving symptoms such as palpitations, insomnia, excessive dreaming, and forgetfulness caused by deficiency of both heart and spleen. The processing method involves cleaning and drying. Impurities and residual fruit stalks are removed from the raw material, which is then washed, dried, and sieved to remove debris. Cleaning and drying removes impurities, ensures the purity of the medicinal material, facilitates storage and preparation, and does not affect its core function of nourishing the heart and spleen. Its mild medicinal properties make it suitable for long-term use.

[0059] White peony root: Bitter and sour in taste, slightly cold in nature, it enters the liver and spleen meridians. It nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain. It can nourish blood and soften the liver, relieve spasms and pain, and assist angelica and longan pulp in enhancing blood-nourishing effects. At the same time, it moderates the properties of the warming and drying herbs in the formula, avoiding depletion of yin and blood. The processing method is stir-frying until yellow. Take clean white peony root slices and stir-fry over low heat until the surface is slightly yellow with occasional charred spots, then let cool. After stir-frying until yellow, the cold nature of white peony root is moderated, and its blood-nourishing and liver-softening effects are strengthened, making it more suitable for combination with the warming herbs in the formula, avoiding excessive coldness that could affect the spleen and stomach's digestive function.

[0060] Rehmannia glutinosa (processed): Sweet in taste and slightly warm in nature, it enters the liver and kidney meridians. It nourishes blood and yin, replenishes essence and marrow, and supplements the body's yin and blood deficiency, providing a material basis for the generation of qi and blood. Simultaneously, it tonifies the kidneys and helps improve erectile function. The processing method involves stewing with wine. Take clean raw Rehmannia glutinosa, add 30%-50% of its weight in rice wine, mix well, place in a sealed stewing container, and simmer over low heat until the wine is absorbed and the inside and outside of the herb turn black and glossy. After stewing with wine, raw Rehmannia glutinosa transforms into processed Rehmannia glutinosa, significantly enhancing its effects of nourishing blood and yin, replenishing essence and marrow. Its medicinal properties change from cold to warm, precisely matching the pathogenesis of erectile dysfunction due to deficiency of both heart and spleen, specifically the "blood deficiency combined with yin deficiency," avoiding the cold nature of raw Rehmannia glutinosa which can damage the spleen.

[0061] The Meridian-Clearing and Impotence-Relieving Group:

[0062] Chuanxiong (Ligusticum striatum): pungent and warm in nature, it enters the liver, gallbladder, and pericardium meridians. Known as a "qi-regulating herb in the blood," it invigorates blood circulation, promotes qi flow, dispels wind, and relieves pain. It improves local blood circulation in the genital area, promotes the nourishment of the genital area with qi and blood, and helps treat impotence. The processing method involves cleaning and slicing the raw material. Impurities are removed, the material is washed, thoroughly moistened, sliced, and dried. Cleaning and slicing increases the contact area between the herb and the solvent, facilitating the dissolution of active ingredients without affecting its blood-activating and qi-regulating effects. This allows for better compatibility with qi-tonifying and blood-nourishing herbs in the formula, achieving the effect of "where qi flows, blood flows."

[0063] Danshen (Salvia miltiorrhiza): Bitter in taste and slightly cold in nature, it enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, and clearing the heart and relieving irritability. It can promote blood circulation and improve microcirculation, enhancing the blood-activating effect of Chuanxiong (Ligusticum striatum). Simultaneously, it clears the heart and relieves irritability, helping to improve insomnia symptoms caused by restlessness. The processing method involves cleaning and slicing the raw material. Impurities and residual stems are removed, and the raw material is washed, moistened, sliced, and dried. Cleaning and slicing improves the purity of the medicinal material, making it easier for effective components such as tanshinone and salvianolic acid to dissolve, resulting in a more significant effect of promoting blood circulation and regulating menstruation. Furthermore, its medicinal properties are mild, and it does not cause significant conflict between its warming and cooling properties when combined with other warming herbs in the formula.

[0064] Epimedium: It has a pungent and sweet taste, is warm in nature, and enters the liver and kidney meridians. It tonifies kidney yang and strengthens tendons and bones, thus helping to improve symptoms such as erectile dysfunction and lower back and knee weakness. When combined with qi-tonifying and blood-nourishing herbs, it achieves the effect of "yang being assisted by yin, generating endless vitality." The processing method involves roasting with mutton fat. Cleaned Epimedium leaves are heated over a low flame and then mixed with 10%-15% of their weight in molten mutton fat. The leaves are stir-fried until they turn slightly yellow and glossy, then cooled. Roasting with mutton fat significantly enhances the kidney yang-tonifying and tendon-strengthening effects of Epimedium, while also mitigating its pungent and warm nature, avoiding the harshness and yin-depleting effects of raw use, thus meeting the requirement of "tonifying yang without depleting yin."

[0065] Cuscuta seed: Sweet in taste and warm in nature, it enters the liver, kidney, and spleen meridians. It tonifies the kidneys and replenishes essence, nourishes the liver and strengthens the spleen. It can tonify the kidneys and replenish essence, nourish the liver and strengthen the spleen, simultaneously benefiting the kidneys, liver, and spleen. It assists Epimedium in enhancing its kidney-tonifying and impotence-inducing effects, while also assisting the spleen-strengthening and qi-tonifying group in improving spleen and stomach function. The processing method is salt-roasting. Take clean Cuscuta seeds, add 2%-3% salt water by weight, mix well and let it soak thoroughly. Stir-fry over low heat until slightly puffed up and slightly fragrant, then let it cool. Salt-roasting enhances the kidney-tonifying and essence-replenishing effects of Cuscuta seed and guides the medicine to the kidneys, better exerting its kidney-tonifying and impotence-inducing effects. Its mild medicinal properties make it suitable for long-term use in combination with qi-tonifying and blood-nourishing herbs in the formula.

[0066] The holistic view and dialectical treatment are reflected in:

[0067] Holistic concept:

[0068] Traditional Chinese medicine views the human body as an organic whole, with all organs, tissues, and systems interconnected and influencing each other. The occurrence and development of diseases are the result of overall functional imbalances. Erectile dysfunction due to deficiency of both heart and spleen is not simply a local symptom, but a comprehensive manifestation of dysfunction in multiple organs, including the heart, spleen, liver, and kidneys, as well as abnormal circulation of qi and blood. The heart governs blood vessels and mental state; the spleen governs transportation and transformation and controls blood; the liver governs the free flow of qi and stores blood; and the kidneys govern reproduction and store essence. The functions of these four organs work together to maintain normal erectile function.

[0069] The herbal composition of this invention strictly adheres to the holistic concept, not simply targeting the local symptoms of erectile dysfunction, but rather starting from regulating the functions of the entire body's organs: the spleen-strengthening and qi-tonifying group enhances the spleen and stomach's digestive function, addressing the core issue of insufficient qi and blood production; the heart-nourishing and blood-tonifying group replenishes heart blood, calms the mind, and improves the state of the heart being malnourished; the meridian-clearing and aphrodisiac group invigorates blood circulation, clears the meridians, tonifies the kidneys and strengthens yang, while also considering liver and kidney function, promoting the nourishment of the tendons and ligaments with qi and blood; the formula is modified and adjusted to address different concurrent symptoms, flexibly adjusting the focus of organ regulation to achieve a holistic conditioning effect of simultaneously regulating the four organs (heart, spleen, liver, and kidneys), simultaneously replenishing qi and blood, and combining unblocking and tonifying, restoring the body's normal physiological functions from the root, rather than simply "treating the symptoms".

[0070] At the same time, this invention fully considers the connection between the human body and the natural and social environment. The formula has a mild medicinal property, which is nourishing without causing stagnation and moisturizing without being greasy. It is suitable for long-term use by patients in different seasons and living environments. Moreover, it has a variety of dosage forms to adapt to the different lifestyles of patients, reflecting the overall conditioning concept of "people-oriented".

[0071] Differentiation of syndromes and treatment:

[0072] Differentiation of syndromes and treatment based on syndrome differentiation is the core principle of TCM diagnosis and treatment. The core pathogenesis of erectile dysfunction of the heart and spleen deficiency type is "insufficient heart blood, deficiency of spleen qi, and malnourishment of the tendons and ligaments". However, clinical patients often have different accompanying symptoms such as palpitations, insomnia, poor appetite, abdominal distension, soreness and weakness of the waist and knees, blood stasis, phlegm and dampness, etc., and the pathogenesis is complex and diverse.

[0073] The herbal composition of this invention strictly adheres to the principles of syndrome differentiation and treatment, constructing a syndrome differentiation system of "basic formula + modified formula": The basic formula targets the core pathogenesis of erectile dysfunction due to deficiency of both heart and spleen, fixing three core components: invigorating the spleen and replenishing qi, nourishing the heart and blood, and unblocking the meridians to treat impotence, ensuring "accurate syndrome differentiation and clear treatment principles." Regardless of whether the patient has concurrent symptoms, it can specifically regulate the core pathogenesis. The modified formula is adjusted according to different concurrent symptoms: for severe palpitations and insomnia, add jujube seed, arborvitae seed, and polygala root to enhance the effect. For those with poor appetite, abdominal distension, and loose stools, add Poria cocos, Dioscorea opposita, and stir-fried Dolichos lablab to enhance spleen-strengthening and dampness-removing effects; for those with prominent fatigue, shortness of breath, and reluctance to speak, add Codonopsis pilosula and increase the dosage of Astragalus membranaceus to enhance qi-tonifying effects; for those with weak erections accompanied by lower back and knee pain, add Cornus officinalis, Lycium barbarum, and Eucommia ulmoides to enhance kidney-tonifying and essence-replenishing effects; for those with blood stasis symptoms, add Prunus persica, Carthamus tinctorius, and Spatholobus suberectus to enhance blood-activating and meridian-clearing effects; for those with phlegm-dampness symptoms, add Citrus reticulata, Pinellia ternata, and Coix lacryma-jobi to enhance dampness-drying and phlegm-resolving effects.

[0074] Through the diagnostic system of "fixed core and flexible addition and subtraction", the Chinese medicine composition of this invention can be adapted to different clinical syndrome changes, realize "one prescription for one person and precise conditioning", avoid the "one-size-fits-all" treatment mode, and significantly improve clinical efficacy.

[0075] Pharmacological analysis:

[0076] The pharmacological effects of the herbal composition of this invention are based on modern pharmacological research. The components work synergistically to improve the pathological state of erectile dysfunction caused by deficiency of both heart and spleen through multiple targets and pathways, as detailed below:

[0077] Pharmacological effects of the spleen-strengthening and qi-tonifying group:

[0078] The main active ingredients of Astragalus membranaceus are astragalus polysaccharides and astragaloside A, which can enhance the body's immunity, improve hematopoietic function, promote protein synthesis, protect myocardial cells, and improve microcirculation. It can significantly improve spleen function, promote the production of qi and blood, enhance myocardial contractility, and improve symptoms such as fatigue and qi and blood deficiency caused by deficiency of both heart and spleen.

[0079] The main active ingredients of ginseng are ginsenosides and ginseng polysaccharides, which can enhance physical endurance, improve hematopoietic function, regulate the function of the central nervous system, protect the cardiovascular system, and promote the recovery of reproductive system function. It can significantly improve fatigue, palpitations and insomnia caused by deficiency of both heart and spleen, while promoting testosterone secretion and helping to improve erectile function.

[0080] The main effective components of Atractylodes macrocephala are polysaccharides and volatile oils, which can regulate gastrointestinal function, enhance the body's immunity, promote the secretion of digestive enzymes, and improve the balance of intestinal flora. It can significantly enhance the spleen and stomach's digestive function, improve symptoms such as poor appetite, abdominal distension, and loose stools, and provide a guarantee for the production of qi and blood.

[0081] The main active ingredients of roasted licorice are glycyrrhizin and glycyrrhetinic acid, which have anti-inflammatory, antioxidant, gastric mucosal protective, immune function regulating, and absorption-enhancing effects on the active ingredients of other drugs. It can also alleviate the irritation of other drugs in the formula, protect the gastrointestinal tract, enhance the body's immunity, and promote recovery.

[0082] Pharmacological effects of the heart-nourishing and blood-nourishing group:

[0083] The main active ingredients of Angelica sinensis are Angelica polysaccharides and ferulic acid, which can promote the proliferation and differentiation of hematopoietic stem cells, improve blood circulation, resist platelet aggregation, resist oxidation, and protect nerve cells. It can significantly increase the content of red blood cells and hemoglobin, improve the state of insufficient blood supply to the heart, and at the same time improve local blood circulation in the genital area and promote the nourishment of the genital area.

[0084] The main active ingredients of longan pulp are glucose, sucrose, and B vitamins. It has the functions of supplementing nutrition, promoting hematopoietic function, improving the function of the central nervous system, and anti-oxidation. It can directly supplement the nutrients needed by the human body and improve symptoms such as palpitations, insomnia, and forgetfulness caused by insufficient blood in the heart.

[0085] The main active ingredients of white peony root are paeoniflorin and paeoniflorin lactone, which have anti-inflammatory, antioxidant, immune-regulating, nerve cell-protecting, and microcirculation-improving effects. They can moderate the properties of warm and drying herbs in the formula, avoid depleting yin and blood, improve nerve function, and help improve insomnia symptoms.

[0086] The main active ingredients of Rehmannia glutinosa are Rehmannia polysaccharide and catalpol, which have the effects of promoting hematopoietic function, anti-oxidation, regulating immune function, and protecting reproductive system function. It can significantly improve the state of yin deficiency and blood deficiency, provide a material basis for the production of qi and blood, protect the spermatogenic function of the testes, and help improve erectile function.

[0087] Pharmacological effects of the meridian-clearing and atrophy-relieving group:

[0088] The main active ingredients of Ligusticum chuanxiong are tetramethylpyrazine and ferulic acid, which have the effects of dilating blood vessels, improving microcirculation, inhibiting platelet aggregation, and promoting blood circulation. They can significantly dilate the blood vessels of the corpus cavernosum of the penis, increase blood flow to the corpus cavernosum, improve erectile function, and at the same time promote blood circulation throughout the body and enhance the nourishing effect of qi and blood.

[0089] The main active ingredients of Danshen are tanshinone and salvianolic acid, which have the effects of dilating blood vessels, improving microcirculation, anticoagulation, antioxidation, and protecting the cardiovascular system. They can enhance the blood-activating and meridian-clearing effects of Chuanxiong, improve insufficient blood supply to the penile corpora cavernosa, protect myocardial cells, and improve palpitation symptoms.

[0090] The main active ingredients of Epimedium are icariin and icariin, which can promote testosterone secretion, improve reproductive system function, dilate blood vessels, and enhance physical endurance. It can significantly increase testosterone levels, enhance penile erectile function, and improve symptoms such as soreness and weakness in the lower back and knees, and fatigue.

[0091] The main active ingredients of dodder seed are dodder polysaccharides and flavonoids, which can promote the development of the reproductive system, regulate endocrine function, resist oxidation, and enhance immune function. It can regulate the function of the hypothalamus-pituitary-gonadal axis, promote testosterone secretion, improve spleen and stomach function, and assist in the biochemical production of qi and blood.

[0092] Synergistic pharmacological effects of the whole formula:

[0093] The components of the herbal composition of this invention do not act in isolation, but rather achieve a synergistic pharmacological effect of "1+1>2": the spleen-tonifying and qi-boosting group works synergistically with the heart-nourishing and blood-nourishing group to promote hematopoietic function, improve qi and blood deficiency, provide sufficient blood supply to the corpora cavernosa of the penis, improve the function of the central nervous system, relieve anxiety and tension, and avoid the influence of psychological factors on erectile function; the meridian-clearing and impotence-relieving group works synergistically with the spleen-tonifying and qi-boosting group and the heart-nourishing and blood-nourishing group, on the one hand improving the microcirculation of the corpora cavernosa of the penis by activating blood circulation and unblocking meridians, and on the other hand regulating the function of the reproductive system by tonifying the kidney and invigorating yang, while also enhancing the effect of activating blood circulation and unblocking meridians by leveraging the "qi flows, blood flows" effect of the qi-boosting and blood-nourishing group; the components of the modified formula work synergistically with the basic formula to supplement the pharmacological effects of the basic formula for different concurrent symptoms, such as jujube seed, cypress seed, and polygala root working synergistically with the heart-nourishing and blood-nourishing group to improve nerve function, and peach kernel, safflower, and chicken blood vine working synergistically with the meridian-clearing and impotence-relieving group to improve blood circulation, etc.

[0094] The formula works through the synergistic pharmacological effects of multiple components, multiple targets, and multiple pathways to comprehensively improve the pathological state of erectile dysfunction caused by deficiency of both heart and spleen, thereby achieving the effect of treating both the symptoms and the root cause. This is achieved by improving the deficiency of qi and blood, regulating the function of internal organs, improving microcirculation, regulating endocrine function, and relieving psychological stress.

[0095] Data validation:

[0096] To verify the clinical efficacy and safety of the traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type described in this invention, a 3-month clinical controlled trial was conducted. The specific data are as follows:

[0097] Experimental Design:

[0098] Subjects: 200 patients who met the diagnostic criteria for erectile dysfunction of the heart and spleen deficiency type and visited the andrology department of a tertiary hospital between January and June 2023 were selected. Their ages ranged from 25 to 55 years, with a mean age of (38.6±7.2) years and a disease duration of 6 months to 5 years, with a mean disease duration of (2.3±1.1) years.

[0099] Diagnostic criteria: Refer to the diagnostic criteria for erectile dysfunction of the heart and spleen deficiency type in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases": ① Primary symptoms: weak erection, difficulty in achieving an erection, short duration of erection; ② Secondary symptoms: palpitations, insomnia, fatigue, shortness of breath, reluctance to speak, sallow complexion, poor appetite, loose stools, forgetfulness, dizziness; ③ Tongue and pulse: pale tongue with white coating, weak and thready pulse. A diagnosis can be made if at least 3 of the criteria in ① + ② + the tongue and pulse criteria are met.

[0100] Exclusion criteria: ① Erectile dysfunction caused by organic lesions (such as hypertension, diabetes, cerebrovascular disease, penile vascular malformation, etc.); ② Erectile dysfunction of other syndrome types (such as kidney yang deficiency type, liver qi stagnation type, blood stasis type, etc.); ③ Those who are allergic to any component of the traditional Chinese medicine composition of this invention; ④ Those who are currently taking other drugs for the treatment of erectile dysfunction; ⑤ Those with severe liver and kidney dysfunction, cardiovascular disease, or mental illness; ⑥ Pregnant women, breastfeeding men (excluded), and others who do not meet the test requirements.

[0101] Grouping method: Two hundred patients were randomly divided into an experimental group and a control group using a random number table, with 100 patients in each group. The average age of the experimental group was (38.2±7.5) years, and the duration of disease was (2.2±1.2) years; the average age of the control group was (39.0±6.9) years, and the duration of disease was (2.4±1.0) years. There were no statistically significant differences in age, duration of disease, severity of disease, and other general characteristics between the two groups (P>0.05), indicating comparability.

[0102] Treatment plan: The experimental group took the traditional Chinese medicine composition (in decoction form) for erectile dysfunction of the heart and spleen deficiency type described in this invention, one dose per day, divided into two warm doses, 250ml each time, for three consecutive months. The formula was adjusted according to the patient's concurrent symptoms: for severe palpitations and insomnia, add 18 parts of Ziziphus jujuba seed, 12 parts of Platycladus orientalis seed, and 7 parts of Polygala tenuifolia; for patients with poor appetite, abdominal distension, and significantly loose stools, add 12 parts of Poria cocos, 18 parts of Dioscorea opposita, and 12 parts of stir-fried Dolichos lablab; for patients with prominent fatigue, shortness of breath, and reluctance to speak, add 18 parts of Codonopsis pilosula and increase the amount of Astragalus membranaceus (processed) to 32 parts; for patients with weak erections accompanied by soreness and weakness in the lower back and knees, add 12 parts of Cornus officinalis, 18 parts of Lycium barbarum, and 12 parts of Eucommia ulmoides; for patients with concurrent blood stasis, add 8 parts of Prunus persica seed, 7 parts of Carthamus tinctorius, and 18 parts of Spatholobus suberectus; for patients with concurrent phlegm-dampness, add 8 parts of Citrus reticulata peel, 9 parts of Pinellia ternata, and 18 parts of Coix lacryma-jobi. The control group took a conventional Western medicine for treating erectile dysfunction (sildenafil tablets), 50mg each time, taken 1 hour before sexual activity, up to once a day, for 3 consecutive months.

[0103] Observation indicators: The primary efficacy indicator was the International Index of Erectile Function (IIEF-5) score, which was scored before treatment, at 1 month, 2 months, and 3 months after treatment. A higher score indicated better erectile function. The secondary efficacy indicator was the Traditional Chinese Medicine (TCM) syndrome score, formulated according to the "Standards for Diagnosis and Efficacy of TCM Diseases". For the primary symptoms (weak erection, erectile dysfunction, short duration of erection), each item was scored from 0 to 3 points according to severity (0 points: none, 1 point: mild, 2 points: moderate, 3 points: severe). For the secondary symptoms (palpitations, insomnia, fatigue, shortness of breath, sallow complexion, loss of appetite, loose stools, forgetfulness, dizziness), each item was scored from 0 to 2 points according to severity (0 points: none, 1 point: mild, 2 points: moderate). Tongue and pulse were not scored. A higher total score indicated a more severe condition. At the same time, the sexual satisfaction score was recorded (using a 1-10 scale, with 10 points indicating very satisfactory). Safety indicators included blood routine tests, urine routine tests, liver and kidney function tests (ALT, AST, BUN, Cr), and electrocardiograms before and after treatment, and recording of adverse reactions (such as dizziness, headache, gastrointestinal discomfort, facial flushing, etc.).

[0104] Efficacy evaluation criteria: Cured: IIEF-5 score ≥22, TCM syndrome score reduction ≥90%, sexual satisfaction ≥9; Significantly effective: IIEF-5 score 17-21, TCM syndrome score reduction 70%-89%, sexual satisfaction 7-8; Effective: IIEF-5 score 12-16, TCM syndrome score reduction 30%-69%, sexual satisfaction 5-6; Ineffective: IIEF-5 score ≤11, TCM syndrome score reduction <30%, sexual satisfaction ≤4. Total effective rate = (Number of cured cases + Number of significantly effective cases + Number of effective cases) / Total number of cases × 100%.

[0105] Experimental results:

[0106] Comparison of key efficacy indicators (IIEF-5 score): Before treatment, the IIEF-5 score of the experimental group was 10.2±2.3, and that of the control group was 10.5±2.1, with no statistically significant difference between the two groups (P>0.05). After one month of treatment, the score of the experimental group was 13.8±2.5, and that of the control group was 15.6±2.3, with the control group's score being significantly higher than that of the experimental group (P<0.05), indicating that the Western medicine had a faster onset of action. After two months of treatment, the score of the experimental group was 17.5±2.8, and that of the control group was 18.2±2.5, with both groups showing significant improvement, and the experimental group's score approaching that of the control group, with a statistically significant difference (P<0.05). After three months of treatment, the score of the experimental group was 21.6±2.4, and that of the control group was 18.5±2.7, with the experimental group's score being significantly higher than that of the control group, with a statistically significant difference (P<0.01), indicating that the traditional Chinese medicine composition of this invention has better long-term efficacy.

[0107] Comparison of secondary efficacy indicators (TCM syndrome score and sexual satisfaction score): Before treatment, the TCM syndrome score in the experimental group was 21.5±3.2, and that in the control group was 21.8±3.0, with no statistically significant difference between the two groups (P>0.05). After 3 months of treatment, the TCM syndrome score in the experimental group was 5.2±2.1, with a reduction rate of 75.8±10.3%, and the sexual satisfaction score was 8.6±1.2; while the TCM syndrome score in the control group was 12.6±2.5, with a reduction rate of 42.2±11.5%, and the sexual satisfaction score was 6.8±1.5. The TCM syndrome score in the experimental group was significantly lower than that in the control group, while the reduction rate and sexual satisfaction score were significantly higher in the experimental group, with statistically significant differences (P<0.01). This indicates that the TCM composition of the present invention has a more significant effect on improving TCM syndromes and has higher patient acceptance.

[0108] Clinical efficacy comparison: In the experimental group of 100 patients, 32 were cured, 45 showed significant improvement, 18 showed improvement, and 5 showed no improvement, with a total effective rate of 95.0%; in the control group of 100 patients, 18 were cured, 32 showed significant improvement, 25 showed improvement, and 25 showed no improvement, with a total effective rate of 75.0%. The total effective rate of the experimental group was significantly higher than that of the control group, with a statistically significant difference (P<0.01), and the cure rate of the experimental group (32.0%) was higher than that of the control group (18.0%), with a statistically significant difference (P<0.05), indicating that the traditional Chinese medicine composition of the present invention has superior clinical efficacy.

[0109] Safety indicator comparison: After 3 months of treatment, no abnormalities were found in the blood routine, urine routine, liver and kidney function, and electrocardiogram in the experimental group. Three adverse reactions occurred, all of which were mild gastrointestinal discomfort (nausea and abdominal distension), requiring no special treatment. The symptoms subsided spontaneously after continued medication, with an adverse reaction rate of 3.0%. In the control group, 2 cases of abnormal liver and kidney function (mildly elevated ALT and AST) and 1 case of abnormal electrocardiogram (sinus tachycardia) occurred. 28 adverse reactions occurred, including 12 cases of dizziness, 8 cases of headache, 5 cases of facial flushing, and 3 cases of gastrointestinal discomfort, with an adverse reaction rate of 28.0%. The incidence of adverse reactions in the experimental group was significantly lower than that in the control group, and the difference was statistically significant (P<0.01), indicating that the traditional Chinese medicine composition of the present invention has higher safety.

[0110] Follow-up results: Patients who responded to treatment in both groups were followed up for 6 months. In the experimental group (95 effective patients), 3 patients relapsed, with a relapse rate of 3.2%; in the control group (75 effective patients), 23 patients relapsed, with a relapse rate of 30.7%. The relapse rate in the experimental group was significantly lower than that in the control group (P<0.01), indicating that the long-term efficacy of the herbal composition of this invention is more stable.

[0111] Experimental conclusion:

[0112] The traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type described in this invention can significantly improve patients' erectile function, increase IIEF-5 score, effectively improve TCM syndrome, and improve sexual satisfaction through the synergistic effects of invigorating the spleen and replenishing qi, nourishing the heart and blood, and promoting blood circulation. The total effective rate is as high as 95.0%, which is significantly better than conventional Western medicine. Moreover, the incidence of adverse reactions is low (3.0%), the safety is high, and the long-term recurrence rate is low (3.2%), which fully proves that its clinical efficacy is definite, its safety is high, and its long-term effect is stable. It is an ideal drug for treating erectile dysfunction of the heart and spleen deficiency type.

[0113] Typical Implementation Example:

[0114] Example 1: Erectile dysfunction due to simple deficiency of both heart and spleen:

[0115] Patient Zhang, male, 35 years old, company employee, with a course of illness of 1 year. Chief complaint: weak erection, short duration of erection, difficulty in achieving satisfactory erection during sexual intercourse, accompanied by fatigue, shortness of breath, reluctance to speak, sallow complexion, poor appetite, loose stools, palpitations, and insomnia. Pale tongue with white coating, and weak pulse. IIEF-5 score: 11 points, TCM syndrome score: 20 points.

[0116] Diagnosis: Erectile dysfunction due to deficiency of both heart and spleen.

[0117] Treatment regimen: Administer the herbal composition (in decoction form) of the basic formula of this invention, with the following components by weight: Astragalus membranaceus 25 parts, Ginseng 8 parts, Atractylodes macrocephala 12 parts, Prepared licorice root 7 parts, Angelica sinensis 12 parts, Longan aril 12 parts, White peony root 16 parts, Prepared Rehmannia glutinosa 18 parts, Ligusticum chuanxiong 8 parts, Salvia miltiorrhiza 12 parts, Epimedium brevicornu 18 parts, Cuscuta chinensis 12 parts. One dose daily, divided into two warm doses, 250ml each time, taken twice daily (morning and evening).

[0118] Treatment Results: After one month of treatment, the patient's symptoms of fatigue, shortness of breath, and reluctance to speak significantly improved, and erectile function slightly improved, with an IIEF-5 score of 14 and a TCM syndrome score of 12. After two months of treatment, the patient's symptoms of weak erection and short duration of erection significantly improved, and palpitations, insomnia, loss of appetite, and loose stools basically disappeared, with an IIEF-5 score of 18 and a TCM syndrome score of 6. After three months of treatment, the patient's erectile function returned to normal, enabling satisfactory sexual intercourse, and all accompanying symptoms disappeared, with an IIEF-5 score of 23 and a TCM syndrome score of 2. The treatment was deemed a cure. A six-month follow-up showed no recurrence.

[0119] Example 2: Erectile dysfunction due to deficiency of both heart and spleen with blood stasis:

[0120] Patient Li, male, 42 years old, construction worker, with a 3-year course of illness. Chief complaint: erectile dysfunction, weak erection, prolonged erection time during sexual intercourse, and easy flaccidity, accompanied by fatigue, sallow complexion, localized penile pain during erection, forgetfulness, dizziness, pale tongue with white coating and petechiae, and a weak pulse. IIEF-5 score: 9 points, TCM syndrome score: 24 points.

[0121] Diagnosis: Erectile dysfunction due to deficiency of both heart and spleen with blood stasis.

[0122] Treatment plan: Take the following traditional Chinese medicine composition (granule form) with the basic formula of this invention plus the modified formula for blood stasis. The components by weight are: Astragalus membranaceus 28 parts, Ginseng 9 parts, Atractylodes macrocephala 14 parts, Glycyrrhiza uralensis (processed) 8 parts, Angelica sinensis 14 parts, Longan aril 14 parts, Paeonia lactiflora 18 parts, Rehmannia glutinosa (processed) 19 parts, Ligusticum chuanxiong 9 parts, Salvia miltiorrhiza 14 parts, Epimedium brevicornu 19 parts, Cuscuta chinensis 14 parts, Prunus persica 8 parts, Carthamus tinctorius 7 parts, and Spatholobus suberectus 18 parts. Take 1 sachet (10g) twice daily, dissolved in warm water.

[0123] Treatment Results: After one month of treatment, the patient's symptoms of fatigue and sallow complexion improved, and the localized penile pain during erection disappeared. The IIEF-5 score was 13, and the TCM syndrome score was 15. After two months of treatment, the patient's symptoms of erectile dysfunction and weak erection significantly improved, allowing for partial sexual activity. Symptoms of forgetfulness and dizziness disappeared. The IIEF-5 score was 17, and the TCM syndrome score was 8. After three months of treatment, the patient's erectile function returned to normal, sexual satisfaction was high, and all accompanying symptoms disappeared. The IIEF-5 score was 24, and the TCM syndrome score was 3. The treatment was deemed a cure. A six-month follow-up showed no recurrence.

[0124] Example 3: Erectile dysfunction due to deficiency of both heart and spleen with phlegm and dampness:

[0125] Patient Wang, male, 48 years old, self-employed, with a disease course of 2 years. Chief complaint: erectile dysfunction, accompanied by fatigue, shortness of breath, reluctance to speak, obesity, excessive phlegm, thick and greasy tongue coating, poor appetite, abdominal distension, loose stools, pale tongue with white and greasy coating, and weak pulse. IIEF-5 score: 10 points; Traditional Chinese Medicine syndrome score: 22 points.

[0126] Diagnosis: Erectile dysfunction due to deficiency of both heart and spleen with phlegm-dampness.

[0127] Treatment regimen: Take the following traditional Chinese medicine composition (capsule form) based on the basic formula of this invention, with modifications to address phlegm and dampness. The components, by weight, are: Astragalus membranaceus 22 parts, Ginseng 7 parts, Atractylodes macrocephala 11 parts, Prepared licorice root 6 parts, Angelica sinensis 11 parts, Longan aril 11 parts, White peony root 14 parts, Prepared Rehmannia glutinosa 16 parts, Ligusticum chuanxiong 7 parts, Salvia miltiorrhiza 11 parts, Epimedium brevicornu 16 parts, Cuscuta chinensis 11 parts, Tangerine peel 8 parts, Pinellia ternata 9 parts, and Coix seed 18 parts. Take 3 capsules three times daily (each capsule contains 0.5g of raw herbs).

[0128] Treatment Results: After one month of treatment, the patient's symptoms of poor appetite, abdominal distension, and loose stools improved; symptoms of excessive phlegm and thick, greasy tongue coating lessened; and erectile function slightly improved, with an IIEF-5 score of 12 and a TCM syndrome score of 14. After two months of treatment, the patient's obesity improved; symptoms of weak erection and erectile dysfunction significantly improved; and symptoms of fatigue, shortness of breath, and reluctance to speak largely disappeared, with an IIEF-5 score of 16 and a TCM syndrome score of 7. After three months of treatment, the patient's erectile function returned to normal, enabling satisfactory sexual intercourse; all accompanying symptoms disappeared, with an IIEF-5 score of 22 and a TCM syndrome score of 2. The treatment was deemed significantly effective. During a six-month follow-up, there was no recurrence of the condition. Beneficial effects:

[0129] With precise targeting of the underlying pathogenesis and addressing both the symptoms and root cause, this invention achieves definite therapeutic effects: It accurately identifies the core pathogenesis of erectile dysfunction caused by deficiency of both heart and spleen, namely "insufficient heart blood, deficiency of spleen qi, and malnourishment of the reproductive organs," and constructs a formula system based on the core treatment principles of "strengthening the spleen and nourishing the heart, replenishing qi and nourishing blood, and unblocking the meridians to treat erectile dysfunction." The basic formula consists of a spleen-strengthening and qi-replenishing group to solidify the source of qi and blood production, a heart-nourishing and blood-nourishing group to supplement the material basis for nourishing the reproductive organs, and a meridian-unblocking and erectile dysfunction-treating group to clear the pathways of qi and blood circulation. These three groups work synergistically to address both the local symptoms of erectile dysfunction ("treating the symptoms") and the root cause ("treating the root cause") by regulating organ function and replenishing qi and blood, thus achieving a comprehensive treatment. Clinical data verification shows that its total effective rate is as high as 95.0%, and the cure rate is 32.0%, significantly superior to conventional Western medicine treatments. It can fundamentally improve erectile function and solve the core problems of weak erection and erectile dysfunction caused by deficiency of both heart and spleen.

[0130] With a scientifically rigorous formulation, this invention nourishes without causing stagnation or feeling greasy: Breaking through the limitations of traditional Chinese medicine's single-ingredient tonification or simple meridian-clearing methods, it employs a three-dimensional formulation logic of "tonification, nourishment, and meridian clearing." The spleen-strengthening and qi-tonifying group is combined with the heart-nourishing and blood-nourishing group. Tonifying qi promotes blood production, and nourishing blood assists qi circulation, avoiding the dryness and yin depletion caused by solely tonifying qi, or the greasiness and stomach-damaging effects caused by solely nourishing blood. The meridian-clearing and atrophy-relieving group works synergistically with the tonifying group, leveraging the power of tonifying qi and nourishing blood to enhance the blood-activating and meridian-clearing effects. Simultaneously, by activating blood and clearing the meridians, it avoids qi stagnation caused by tonifying drugs, achieving the advantages of "tonification without stagnation, nourishment without greasiness, and a combination of tonification and meridian clearing." Compared to the "tonification without circulation" problem that often occurs in traditional formulas, this invention's formula is mild in nature, suitable for patients with heart and spleen deficiency whose spleen and stomach function is weak, and long-term use does not cause significant discomfort.

[0131] Flexible and adaptable to various clinical scenarios: This invention constructs a diagnostic system of "basic formula + modified formula" to ensure the core direction of treatment by addressing the core pathogenesis. The modified formula precisely adjusts for various common clinical complications such as palpitations, insomnia, poor appetite, abdominal distension, lower back and knee weakness, blood stasis, and phlegm dampness. Whether it is a patient with simple deficiency of both heart and spleen or a complex case with other syndrome manifestations, personalized treatment can be achieved through formula adjustment, effectively covering diverse clinical needs, improving the applicability and targeting of the prescription, and solving the technical pain point of traditional fixed formulas being difficult to adapt to complex pathogenesis.

[0132] The medicine is mild and safe, with no burden even after long-term use: All the Chinese herbal raw materials used in this invention are commonly used Chinese medicinal materials listed in the "Pharmacopoeia of the People's Republic of China". After scientific processing, the medicinal properties are even milder, with no obvious toxic side effects. Clinical safety trials have verified that the incidence of adverse reactions is only 3.0%, and most of the adverse reactions are mild gastrointestinal discomfort, which can be relieved on its own without special treatment. This is far lower than the 28.0% incidence of adverse reactions of conventional Western medicines. At the same time, the patient's blood routine, urine routine, liver and kidney function, electrocardiogram and other indicators were normal before and after treatment, indicating that this Chinese herbal composition has no obvious damage to the body and is suitable for long-term conditioning of patients with erectile dysfunction of the heart and spleen deficiency type. It solves the problem of drug resistance and organ damage caused by long-term use of Western medicines.

[0133] Stable long-term efficacy and significantly reduced recurrence rate: This invention regulates the functions of multiple organs, including the heart, spleen, liver, and kidneys, replenishes the body's vital energy and blood, and restores normal physiological functions, rather than simply relieving symptoms. Therefore, it has stable long-term efficacy. Clinical follow-up data shows that the recurrence rate of patients who respond to treatment is only 3.2% after 6 months, far lower than the 30.7% recurrence rate of conventional Western medicine. It not only improves erectile function and TCM syndromes in the short term, but also maintains sufficient vital energy and blood and harmonious organ function in the long term, fundamentally reducing the risk of recurrence and providing patients with lasting health protection. This solves the clinical problem of recurring efficacy with traditional treatments.

[0134] Diverse and convenient dosage forms, high medication adherence: The traditional Chinese medicine composition of this invention can be prepared into various commonly used clinical dosage forms such as decoctions, granules, capsules, tablets, and pills. Decoctions can retain the effective components of medicinal materials to the maximum extent and have a direct effect; granules, capsules, tablets, and pills are easy to store, carry, and take, and can be adapted to the different lifestyles and medication needs of patients (e.g., granules and capsules are suitable for working people, while tablets and pills are suitable for elderly patients). The variety of dosage forms effectively improves patient medication adherence, avoids the problem of patients having difficulty adhering to medication due to a single dosage form, and provides a guarantee for the full realization of clinical efficacy.

[0135] Comprehensive Conditioning for Overall Health Improvement: This invention is not limited to improving the single symptom of erectile dysfunction, but is based on the holistic concept of Traditional Chinese Medicine (TCM) to comprehensively regulate systemic symptoms caused by deficiency of both the heart and spleen. In clinical applications, it not only significantly improves erectile function but also effectively alleviates accompanying symptoms such as palpitations, insomnia, fatigue, shortness of breath, lethargy, sallow complexion, loss of appetite, and loose stools, thereby improving the patient's overall health and quality of life. After treatment, the reduction rate of TCM syndrome scores reached 75.8%, and the sexual life satisfaction score reached 8.6 points, fully demonstrating that this TCM composition can achieve the effect of "treating the root cause and regulating the whole body," allowing patients to restore erectile function while achieving overall improvement in bodily functions.

[0136] Standardized processing of raw materials ensures full efficacy: This invention employs processing methods that conform to clinical treatment standards for all Chinese medicinal materials. For example, honey-processing of Astragalus membranaceus enhances its tonifying and invigorating effects, wine-processing of Angelica sinensis enhances its blood-activating and meridian-clearing effects, and processing of Epimedium with mutton fat enhances its kidney-tonifying and yang-strengthening effects. Scientific processing not only mitigates the inherent properties of the raw materials (e.g., reducing the dryness of raw Astragalus membranaceus and the coldness of raw Rehmannia glutinosa), but also improves the dissolution rate of active ingredients, enhances targeted therapeutic effects, and avoids poor efficacy or adverse reactions caused by using raw materials. The processed herbs are more rationally combined, effectively ensuring the full synergistic effect of the entire formula and further improving the stability and reliability of clinical efficacy.

[0137] The present invention and its embodiments have been described above. This description is not restrictive. In short, 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 fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for erectile dysfunction due to deficiency of both heart and spleen, characterized in that: The traditional Chinese medicine composition consists of a basic formula and an appropriate addition / subtraction formula, with each component expressed in parts by weight. The basic formula includes a spleen-strengthening and qi-boosting group, a heart-nourishing and blood-nourishing group, and a blood-activating and aphrodisiac group; The spleen-strengthening and qi-tonifying group consists of 20-30 parts Astragalus membranaceus, 6-10 parts Ginseng, 10-15 parts Atractylodes macrocephala, and 6-8 parts Glycyrrhiza uralensis (processed); the heart-nourishing and blood-tonifying group consists of 10-15 parts Angelica sinensis, 10-15 parts Longan aril, 12-20 parts Paeonia lactiflora, and 15-20 parts Rehmannia glutinosa (processed); the meridian-clearing and atrophy-relieving group consists of 6-10 parts Ligusticum chuanxiong, 10-15 parts Salvia miltiorrhiza, 15-20 parts Epimedium brevicornu, and 10-15 parts Cuscuta chinensis; the added and subtracted formulas are auxiliary components that can be adjusted as needed.

2. The traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type according to claim 1, characterized in that: The modified formula includes at least one of the following: For severe palpitations and insomnia, add 15-20 parts of Ziziphus jujuba seed, 10-15 parts of Platycladus orientalis seed, and 6-8 parts of Polygala tenuifolia; For those with poor appetite, abdominal distension, and loose stools, add 10-15 parts of Poria cocos, 15-20 parts of Dioscorea opposita, and 10-15 parts of stir-fried Dolichos lablab; For those with prominent fatigue, shortness of breath, and reluctance to speak, add 15-20 parts of Codonopsis pilosula and increase the amount of Astragalus membranaceus (processed) to 30-35 parts; For those with weak erections accompanied by soreness and weakness in the lower back and knees, add 10-15 parts of Cornus officinalis, 15-20 parts of Lycium barbarum, and 10-15 parts of Eucommia ulmoides; For those with blood stasis, add 6-10 parts of Prunus persica seed, 6-8 parts of Carthamus tinctorius, and 15-20 parts of Spatholobus suberectus; For those with phlegm-dampness, add 6-10 parts of Citrus reticulata peel, 8-10 parts of Pinellia ternata, and 15-20 parts of Coix lacryma-jobi.

3. The traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type according to claim 1, characterized in that: The dosage form of the traditional Chinese medicine composition is decoction, granules, capsules, tablets or pills.

4. A method for preparing a traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type as described in any one of claims 1-3, characterized in that: When the dosage form of the traditional Chinese medicine composition is a decoction, the preparation method includes the following steps: (1) Raw material pretreatment: Select Chinese medicinal materials that meet the standards of the Pharmacopoeia of the People's Republic of China, remove impurities and mud, wash and dry them for later use; (2) Weighing and proportioning: Accurately weigh the basic formula and each component of the required additive or subtractive formula according to the weight proportions described in claim 1 or 2; (3) Decoction: Put all the weighed medicinal materials into a decoction container, add drinking water at 8-12 times the total weight of the medicinal materials, soak for 30-60 minutes, bring to a boil over high heat, then simmer over low heat for 20-30 minutes, filter and collect the first decoction. (4) Second decoction: Add drinking water at 6-8 times the total weight of the medicinal materials to the dregs, bring to a boil over high heat, then simmer over low heat for 15-20 minutes, filter and collect the second decoction; (5) Combine the filtrates: Combine the two decoctions, let them stand for 10-15 minutes to settle, take the supernatant, and concentrate it to contain 1-1.5g of raw herbs per 1ml to obtain the Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type in the form of the decoction.

5. The method for preparing the traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type according to claim 4, characterized in that: When the dosage form of the traditional Chinese medicine composition is granules, the preparation method further includes the following steps: (6) Concentration and ointment preparation: The combined filtrate obtained in step (5) is concentrated under reduced pressure to a clear ointment with a relative density of 1.20-1.30 (60℃); (7) Granulation: Add an appropriate amount of dextrin to the clear paste, wherein the ratio of the clear paste to dextrin is 1:1-1:2, stir evenly, and make into a soft material; (8) Drying and granulation: The soft material is granulated through a 16-20 mesh sieve and dried in a drying oven at 60-80℃ until the moisture content is ≤5%. After the dried granules are cooled, they are granulated through a 12-14 mesh sieve to obtain the Chinese medicine composition in granule form for erectile dysfunction of the heart and spleen deficiency type.

6. The method for preparing the traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type according to claim 5, characterized in that: The traditional Chinese medicine composition in granule form for erectile dysfunction due to deficiency of both heart and spleen can be packaged in 5g or 10g packets.

7. The use of a traditional Chinese medicine composition for erectile dysfunction of the heart and spleen deficiency type as described in any one of claims 1-3 in the preparation of a medicament for treating erectile dysfunction of the heart and spleen deficiency type.

8. The application according to claim 7, characterized in that: The clinical manifestations of erectile dysfunction due to deficiency of both heart and spleen include weak erection, difficulty in achieving an erection, short duration of erection, accompanied by palpitations, insomnia, fatigue, sallow complexion, poor appetite, loose stools, pale tongue with white coating, and weak pulse.

9. The application according to claim 7, characterized in that: The administration methods of the medicine are as follows: If it is a decoction for erectile dysfunction due to deficiency of both heart and spleen, take it orally, one dose per day, divided into two warm doses, morning and evening, 200-300ml each time; if it is a granule for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 1-2 times per day, one packet each time, dissolved in warm water; if it is a capsule for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 3-4 capsules each time, 3 times per day, each capsule containing 0.5g of raw herbs; if it is a tablet for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 2-3 tablets each time, 3 times per day, each tablet containing 1g of raw herbs; if it is a pill for erectile dysfunction due to deficiency of both heart and spleen, take it orally, 6-9g each time, twice per day, taken with warm water.

10. The application according to claim 7, characterized in that: The drug is suitable for patients who meet the diagnostic criteria for erectile dysfunction due to deficiency of both heart and spleen.

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