A traditional Chinese medicine composition for tonifying kidney and nourishing heart and improving male reproductive function

Abstract

This invention discloses a traditional Chinese medicine composition for tonifying the kidneys and heart and improving male reproductive function, belonging to the field of traditional Chinese medicine technology, specifically involving a compound traditional Chinese medicine technique for regulating male organ function and improving reproductive health. The composition consists of 18 traditional Chinese medicinal materials, including 40-50 parts ginseng leaves, 40-50 parts Ophiopogon japonicus, 8-12 parts vinegar-processed Schisandra chinensis, and 55-65 parts Rehmannia glutinosa, strictly formulated according to specific weight ratios. A preferred ratio is 45 parts ginseng leaves, 45 parts Ophiopogon japonicus, and 10 parts vinegar-processed Schisandra chinensis. This invention also discloses a specific preparation method for the traditional Chinese medicine composition, a traditional Chinese medicine preparation containing the composition, and its related applications. The preparation can be formulated into conventional pharmaceutical dosage forms such as granules, capsules, and tablets according to actual needs, suitable for daily conditioning and auxiliary improvement of male sub-health conditions and decreased reproductive function.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition that has the effects of tonifying the kidney and nourishing the heart, and can effectively relieve male fatigue, improve male erectile function and sperm quality. It also relates to the preparation method of the traditional Chinese medicine composition and its application in the preparation of related drugs, belonging to the field of compound traditional Chinese medicine research and application technology. Background Technology

[0002] With the ever-accelerating pace of modern life and increasing workplace competition, coupled with the widespread influence of unhealthy lifestyle habits such as irregular work and rest, staying up late, unbalanced diet, and lack of exercise, traditional Chinese medicine (TCM) syndromes such as kidney deficiency, heart yin deficiency, qi and blood deficiency, and damp-heat stagnation are becoming increasingly prominent among men and are showing a trend towards affecting younger men. The main clinical manifestations include persistent fatigue, weakness in the lower back and knees, dizziness and tinnitus, palpitations, insomnia, lethargy, and memory loss. These are often accompanied by reproductive health problems such as erectile dysfunction, decreased libido, reduced sperm count, decreased sperm motility, and increased sperm abnormalities. This not only seriously affects men's quality of life but may also negatively impact family harmony and fertility.

[0003] Currently, Western medicine primarily addresses male fatigue and decreased reproductive function through symptomatic treatments such as hormone supplementation and nutritional interventions. While these methods can alleviate some symptoms in the short term, they suffer from inherent drawbacks, including significant side effects, potential dependence with long-term use, and a failure to address the root cause of male organ dysfunction. Traditional Chinese medicine (TCM), on the other hand, possesses unique advantages in regulating male reproductive health. Its core treatment philosophy is holistic diagnosis and treatment that addresses both the symptoms and the underlying cause. Through scientifically formulated combinations of herbs that tonify the kidneys and heart, replenish qi and yin, invigorate blood circulation, and resolve dampness and strengthen the spleen, TCM addresses the root cause of organ dysfunction and improves overall health, thus comprehensively enhancing male reproductive health. TCM is characterized by its safety, gentleness, long-lasting effects, and lack of significant dependence, making it more suitable for long-term use.

[0004] A search of existing publicly available literature on traditional Chinese medicine (TCM) techniques and related patents revealed no identical technical solutions to the formulation of this invention, which simultaneously tonifies the kidneys and nourishes the heart while improving male erectile function and sperm quality. This invention, based on the inventor's extensive clinical experience and combined with TCM diagnostic and treatment theories, has undergone multiple optimizations and experimental verifications. It effectively fills a gap in existing technologies in this field, providing a new technical option for male reproductive health management. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the core objective of this invention is to provide a scientifically formulated, effective, and stable traditional Chinese medicine composition with no significant toxic side effects. This composition is primarily used to tonify the kidneys and heart, alleviate persistent fatigue symptoms in men, improve erectile function, and increase sperm count and quality. It is particularly suitable for men experiencing sub-health conditions and decreased reproductive function due to kidney deficiency, heart deficiency, insufficient qi and blood, and damp-heat stagnation, providing a safe, effective, and gentle compound traditional Chinese medicine option for male reproductive health conditioning.

[0006] The technical solution adopted by this invention to solve its technical problem is: A traditional Chinese medicine composition for tonifying the kidneys and heart and improving male reproductive function is composed of the following medicinal materials in proportion to their respective weights: ginseng leaves 40-50 parts, ophiopogon japonicus 40-50 parts, schisandra chinensis (processed with vinegar) 8-12 parts, rehmannia glutinosa 55-65 parts, deer antler 18-22 parts, turtle shell 18-22 parts, tortoise shell 18-22 parts, chicken gizzard lining 55-65 parts, patrinia scabiosaefolia 25-35 parts, chicken blood vine 25-35 parts, privet fruit 25-35 parts, eclipta prostrata 25-35 parts, poria cocos 40-50 parts, cimicifuga foetida 8-12 parts, agrimony 95-105 parts, patchouli 12-18 parts, eupatorium fortunei 12-18 parts, and acorus tatarinowii 12-18 parts. All the above-mentioned medicinal materials are selected from high-quality medicinal materials that meet the standards of the Pharmacopoeia of the People's Republic of China to ensure the safety and stability of the formulation.

[0007] Optimal formulation: After multiple trials and clinical application optimizations, the optimal formulation of this invention is as follows: 45 parts ginseng leaf, 45 parts ophiopogon japonicus, 10 parts vinegar-processed schisandra chinensis, 60 parts rehmannia glutinosa, 20 parts deer antler, 20 parts turtle shell, 20 parts tortoise shell, 60 parts chicken gizzard lining, 30 parts patrinia scabiosaefolia, 30 parts chicken blood vine, 30 parts privet fruit, 30 parts eclipta prostrata, 45 parts poria cocos, 10 parts cimicifuga foetida, 100 parts agrimony, 15 parts patchouli, 15 parts eupatorium fortunei, and 15 parts acorus tatarinowii. This optimal formulation maximizes the efficacy of each herb, achieves the best synergistic effect, and provides a more precise conditioning effect.

[0008] The efficacy and compatibility mechanisms of the above-mentioned medicinal materials are as follows: 1. Principal ingredients: deer antler, tortoise shell, turtle shell, and rehmannia root. Deer antler is sweet and salty in taste, warm in nature, and enters the liver and kidney meridians. It has the core effects of warming the kidneys and strengthening yang, nourishing essence and blood, and is a key medicinal material for tonifying kidney yang and replenishing kidney essence. Tortoise shell is sweet and salty in taste, slightly cold in nature, and enters the liver, kidney, and heart meridians. Soft-shelled turtle shell is salty in taste, slightly cold in nature, and enters the liver and kidney meridians. Both have the effects of nourishing yin and suppressing yang, tonifying the kidneys and replenishing essence, nourishing blood and tonifying the heart, and can compensate for the dryness and heat that may result from excessive kidney yang. Rehmannia root is sweet and bitter in taste, cold in nature, and enters the heart, liver, and kidney meridians. It has the effects of clearing heat and cooling blood, nourishing yin and generating fluids, and can nourish yin and moisten dryness, harmonizing the overall cold and heat balance of the formula. The four herbs combined achieve the core effect of tonifying both yin and yang, replenishing essence and marrow. As the core of the entire formula for tonifying the kidneys, it can fundamentally improve problems such as poor erection and weakness caused by kidney deficiency.

[0009] 2. Assistant herbs: Ginseng leaf, Ophiopogon japonicus, Vinegar-processed Schisandra chinensis, Ligustrum lucidum, Eclipta prostrata, Poria cocos Ginseng leaves are sweet and slightly bitter, cool in nature, and enter the lung and stomach meridians. They have the effects of replenishing qi and nourishing yin, relieving fatigue, promoting body fluids and calming the mind, and can effectively relieve symptoms of persistent fatigue in men. Ophiopogon japonicus is sweet and slightly bitter, slightly cold in nature, and enters the heart, lung, and stomach meridians. It has the effects of nourishing yin and promoting body fluids, moistening the lungs and clearing the heart, and can nourish heart yin and improve palpitations and insomnia. Vinegar-processed Schisandra chinensis is sour and sweet, warm in nature, and enters the lung, heart, and kidney meridians. After being processed with vinegar, it has enhanced astringent, qi-replenishing, body fluid-generating, kidney-tonifying, and heart-calming effects, and can consolidate essence and replenish qi, calm the mind and aid sleep. Ligustrum lucidum is sweet and bitter, cool in nature, and Eclipta prostrata is sweet and sour, cold in nature. Both enter the liver and kidney meridians and work together to nourish the liver and kidneys, cool the blood and stop bleeding, and further assist in tonifying the kidneys and replenishing essence. Poria cocos is sweet and bland, neutral in nature, and enters the heart and spleen meridians. It has the effects of calming the mind and soothing the nerves, strengthening the spleen and promoting diuresis, and can improve symptoms such as restlessness, insomnia, and forgetfulness. The aforementioned assistant herbs work synergistically with the principal herbs to replenish qi and nourish yin, tonify the kidneys and nourish the heart, calm the mind and combat fatigue, effectively improving problems such as palpitations, insomnia, and mental exhaustion in men.

[0010] 3. Adjuvant herbs: Chicken gizzard lining, Patrinia scabiosaefolia, Spatholobus suberectus, Cimicifuga foetida, Agrimonia pilosa Chicken gizzard lining is sweet in taste and neutral in nature, entering the spleen, stomach, small intestine, and bladder meridians. It has the effects of strengthening the spleen and promoting digestion, consolidating essence and stopping seminal emission. It can help the spleen and stomach to digest and prevent the tonifying herbs in the principal and assistant herbs from being too greasy and affecting digestion and absorption. Patrinia scabiosaefolia is pungent and bitter in taste and slightly cold in nature, entering the stomach, large intestine, and liver meridians. It has the effects of clearing heat and detoxifying, removing blood stasis and promoting diuresis. It can clear damp heat in the lower burner and relieve discomfort caused by damp heat stagnation. Spatholobus suberectus is sweet and bitter in taste and warm in nature, entering the liver and kidney meridians. The formula contains herbs that invigorate blood circulation, nourish blood, and relax muscles and tendons, improving blood flow in the genital area and providing support for erectile function. Cimicifuga rhizome is pungent and sweet, slightly cold in nature, and enters the lung, spleen, stomach, and large intestine meridians. It has the effect of raising yang and lifting prolapse, enhancing the body's yang energy and helping to improve lethargy. Agrimonia pilosa is bitter and astringent, neutral in nature, and enters the heart and liver meridians. It has the effects of astringing and stopping bleeding, tonifying deficiency and stopping diarrhea, and invigorating qi and refreshing the mind, strengthening the body's vital energy and relieving fatigue. The combination of these adjuvant herbs allows the entire formula to achieve the effect of tonifying without stagnation and clearing without harm, improving erectile function by invigorating blood circulation and enhancing male vitality by invigorating qi and nourishing deficiency.

[0011] 4. Medicinal herbs: Patchouli, Eupatorium fortunei, Acorus tatarinowii Patchouli is pungent and slightly warm in nature, and enters the spleen, stomach, and lung meridians. Eupatorium fortunei is pungent and neutral in nature, and also enters the spleen, stomach, and lung meridians. Both have the effects of resolving dampness and harmonizing the middle jiao, invigorating the spleen and stimulating appetite. They can remove dampness and turbidity, and improve problems such as fatigue, weakness, and loss of appetite caused by dampness affecting the spleen. Acorus tatarinowii is pungent and bitter, and warm in nature, and enters the heart and stomach meridians. It has the effects of opening the orifices and invigorating the mind, resolving dampness and harmonizing the stomach, and harmonizing the heart and kidneys. It can regulate the relationship between the heart and kidneys and improve restlessness. As adjuvant herbs, these three herbs can harmonize the properties of all the herbs in the formula, invigorate the spleen and promote digestion, and enhance the body's absorption of the effective components of the herbs, thereby further enhancing the overall therapeutic effect.

[0012] Overall efficacy: Combining the above-mentioned effects of the combination of principal, assistant, adjuvant and guide herbs, the Chinese herbal composition of the present invention has the overall effects of tonifying the kidney and replenishing essence, nourishing the heart and calming the mind, replenishing qi and nourishing yin, promoting blood circulation and unblocking collaterals, and resolving dampness and strengthening the spleen. It can comprehensively regulate the function of male organs and balance yin and yang qi and blood.

[0013] Indications: The herbal composition of this invention is mainly used to treat various discomfort symptoms in men caused by kidney deficiency, heart and spleen deficiency, insufficient qi and blood, and damp-heat stagnation. Specifically, these include: general fatigue and weakness, soreness and weakness of the waist and knees, dizziness and tinnitus, lethargy, insomnia and forgetfulness, memory loss; reproductive function-related problems such as erectile dysfunction, low libido, and weak erection; and sperm quality abnormalities such as low sperm count, low motility, high abnormality rate, and abnormal liquefaction.

[0014] Furthermore, a method for preparing a traditional Chinese medicine composition that tonifies the kidneys and heart and improves male reproductive function is as follows: Step 1: Raw material pretreatment: Accurately weigh all Chinese medicinal materials according to the above weight ratio, clean each material to remove impurities, mud and sand and non-medicinal parts, then wash with purified water to remove surface dust and residual impurities. After washing, place in a ventilated and dry place for drying to ensure that the moisture content of the medicinal materials meets the preparation requirements and avoid mold growth in the subsequent preparation process.

[0015] Step 2: Pre-decoction: Crush the three hard Chinese medicinal materials, deer antler, turtle shell and tortoise shell, which are difficult to extract their active ingredients into a suitable particle size, put them into a decoction container, add an appropriate amount of purified water, soak for 30 minutes, bring to a boil over high heat, and then simmer over low heat for 1 to 2 hours to ensure that their active ingredients are fully dissolved.

[0016] Step 3: Second decoction: After processing the remaining 15 Chinese medicinal herbs as required, add them to the above decoction container, add an appropriate amount of purified water to cover the surface of the herbs by 3-5cm, bring to a boil over high heat, then simmer over low heat twice, each time for 1-1.5 hours. After decoction, filter the two decoctions separately and combine them to obtain a mixed decoction.

[0017] Step 4: Concentration and Drying: Filter the combined decoction with a filter cloth to remove the dregs and insoluble impurities, and obtain a clear decoction. Place the clear decoction in a concentration device and concentrate it under reduced pressure at a suitable temperature until it becomes a clear extract with a relative density of 1.10~1.20 (60℃). Then place the clear extract in a drying device and use spray drying or vacuum drying to make a dry extract powder for later use.

[0018] Step 5: Dosage Form Preparation: Based on actual pharmaceutical needs, add pharmaceutically acceptable excipients such as starch, lactose, and magnesium stearate to the above-mentioned extract powder. After thorough mixing, prepare various conventional pharmaceutical dosage forms such as granules, capsules, tablets, pills, and oral liquids according to conventional Chinese medicine preparation processes, which are convenient for clinical use and patient administration.

[0019] Compared with the prior art, the technical solution of this application has at least the following beneficial effects: This invention combines the physical characteristics of modern men with a combination of yin and yang tonification, heart and kidney regulation, and tonification and unblocking. It focuses on tonifying the kidneys and replenishing essence, nourishing the heart and calming the mind, while also promoting blood circulation, clearing the meridians, resolving dampness and strengthening the spleen. It has no obvious cold or heat bias, and its medicinal properties are mild, making it suitable for long-term conditioning for men with different constitutions.

[0020] Compared with existing single-effect traditional Chinese medicine compositions, this invention can simultaneously improve male fatigue symptoms, sleep quality, and mental state, while also specifically improving erectile function, optimizing sperm count, motility, and quality. It achieves multi-dimensional conditioning, fundamentally solving various problems caused by male kidney deficiency, heart and spleen deficiency, and insufficient qi and blood, with comprehensive and definite conditioning effects.

[0021] This invention is a pure traditional Chinese medicine formula. All medicinal materials are selected from high-quality Chinese medicinal materials that meet the pharmacopoeia standards. No hormones, chemical additives, or preservatives are added. Clinical observation has verified that there are no obvious toxic side effects. Long-term use will not produce dependence. Patient compliance is high, and it is suitable for long-term conditioning.

[0022] The herbal composition of this invention is suitable for a wide range of people, including men with decreased reproductive function and abnormal sperm quality, as well as men who are in a sub-healthy state, fatigued, weak, insomnia and forgetful. It can also be used as a daily conditioning medicine for men who are trying to conceive, and has good application prospects. Attached Figure Description

[0023] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments and comparative examples will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram comparing the overall effectiveness of the embodiments and comparative examples involved in the present invention; Figure 2 This is a schematic diagram comparing the erectile function effectiveness of the embodiments and comparative examples involved in the present invention; Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0026] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other. The present invention will now be described in detail with reference to specific embodiments.

[0027] Example 1 A kidney-tonifying and heart-nourishing traditional Chinese medicine composition, comprising the following raw materials by weight: ginseng leaf 45g, ophiopogon japonicus 45g, vinegar-processed schisandra chinensis 10g, rehmannia glutinosa 60g, deer antler 20g, turtle shell 20g, tortoise shell 20g, chicken gizzard lining 60g, patrinia scabiosaefolia 30g, chicken blood vine 30g, privet fruit 30g, eclipta prostrata 30g, poria cocos 45g, cimicifuga foetida 10g, agrimony 100g, patchouli 15g, eupatorium fortunei 15g, and acorus tatarinowii 15g. All medicinal materials are selected from high-quality materials that meet the standards of the 2020 edition of the Pharmacopoeia of the People's Republic of China to ensure the quality of raw materials.

[0028] Preparation method: Crush deer antler, turtle shell, and tortoise shell to a particle size of 20-40 mesh, put them into a decoction pot, add 1000ml of purified water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 1.5 hours; then add the remaining 15 Chinese medicinal materials, add purified water to cover the surface of the medicinal materials by 4cm, bring to a boil over high heat, then simmer twice over low heat for 1 hour each time, combine the two filtrates, filter with a filter cloth to remove the dregs, and obtain a clear decoction; concentrate the clear decoction under reduced pressure to a clear extract with a relative density of 1.15 (60℃), spray dry to make an extract powder; add an appropriate amount of starch to the extract powder, mix evenly, granulate, dry and fill into capsules, each capsule weighing 0.5g, to obtain the capsule formulation of the Chinese medicine composition of this invention.

[0029] Dosage and administration: Take 2-3 capsules orally twice a day with warm water. It is more effective to take it after meals. One treatment cycle is 4 weeks. Depending on your own situation, you can take it for 2-3 cycles. There are no obvious discomforts with long-term use.

[0030] Example 2 A kidney-tonifying and heart-nourishing traditional Chinese medicine composition comprises the following raw materials in parts by weight: ginseng leaf 48g, ophiopogon japonicus 48g, schisandra chinensis (vinegar-processed) 11g, rehmannia glutinosa 62g, deer antler 21g, turtle shell 21g, tortoise shell 21g, chicken gizzard lining 62g, patrinia scabiosaefolia 32g, chicken blood vine 32g, privet fruit 32g, eclipta prostrata 32g, poria cocos 48g, cimicifuga foetida 11g, agrimony 102g, agastache rugosa 16g, eupatorium fortunei 16g, and acorus tatarinowii 16g. The preparation method is the same as in Example 1. The extract powder is mixed evenly with an appropriate amount of lactose and magnesium stearate, then granulated, dried, and packaged in bags of 5g each, thus obtaining the granules of the traditional Chinese medicine composition of this invention. Dosage and administration: Oral administration, one bag each time, twice a day, dissolved in warm water, taken after meals.

[0031] Example 3 A kidney-tonifying and heart-nourishing traditional Chinese medicine composition comprises the following raw materials in parts by weight: ginseng leaf 40g, ophiopogon japonicus 40g, schisandra chinensis (vinegar-processed) 8g, rehmannia glutinosa 55g, deer antler 18g, turtle shell 18g, tortoise shell 18g, chicken gizzard lining 55g, patrinia scabiosaefolia 25g, chicken blood vine 25g, privet fruit 25g, eclipta prostrata 25g, poria cocos 40g, cimicifuga foetida 8g, agrimony 95g, patchouli 12g, eupatorium fortunei 12g, and acorus tatarinowii 12g. The preparation method is the same as in Example 1. The extract powder is mixed evenly with an appropriate amount of starch and magnesium stearate, and then compressed into tablets, each weighing 0.3g, thus obtaining the tablets of the traditional Chinese medicine composition of this invention. Dosage and administration: Oral administration, 3-4 tablets each time, twice a day, taken with warm water after meals.

[0032] Example 4 A kidney-tonifying and heart-nourishing traditional Chinese medicine composition comprises the following raw materials in parts by weight: 50g ginseng leaf, 50g Ophiopogon japonicus, 12g vinegar-processed Schisandra chinensis, 65g Rehmannia glutinosa, 22g deer antler, 22g turtle shell, 22g tortoise shell, 65g chicken gizzard lining, 35g Patrinia scabiosaefolia, 35g Spatholobus suberectus, 35g Ligustrum lucidum, 35g Eclipta prostrata, 50g Poria cocos, 12g Cimicifuga foetida, 105g Agrimonia pilosa, 18g Pogostemon cablin, 18g Eupatorium fortunei, and 18g Acorus tatarinowii. The preparation method is the same as in Example 1. The extract powder is added to purified water and an appropriate amount of sweetener, stirred evenly, and then made into an oral liquid. Each vial contains 10ml, thus obtaining the oral liquid of the traditional Chinese medicine composition of this invention. Dosage and administration: Oral administration, one vial each time, twice a day, after meals.

[0033] Example 5 A kidney-tonifying and heart-nourishing traditional Chinese medicine composition, with the following preferred weight ratio of raw materials: ginseng leaf 45g, ophiopogon japonicus 45g, schisandra chinensis (vinegar-processed) 10g, rehmannia glutinosa 60g, deer antler 20g, turtle shell 20g, tortoise shell 20g, chicken gizzard lining 60g, patrinia scabiosaefolia 30g, chicken blood vine 30g, privet fruit 30g, eclipta prostrata 30g, poria cocos 45g, cimicifuga foetida 10g, agrimony 100g, agastache rugosa 15g, eupatorium fortunei 15g, and acorus tatarinowii 15g. Preparation method: Crush deer antler, turtle shell, and tortoise shell to 20-40 mesh, decoct for 1.5 hours, add the remaining medicinal materials and decoct twice, 1 hour each time. Combine the filtrates, concentrate and dry to obtain an extract powder; add appropriate amounts of honey and starch to the extract powder, mix evenly, and make into honey pills, each weighing 9g, thus obtaining the pill form of the traditional Chinese medicine composition of this invention. Dosage and administration: Take one pill orally twice a day with warm water after meals.

[0034] Comparative Example 1 A traditional Chinese medicine composition comprises the following raw materials in parts by weight: ginseng leaf 45g, ophiopogon japonicus 45g, schisandra chinensis (processed with vinegar) 10g, rehmannia glutinosa 60g, turtle shell 20g, tortoise shell 20g, chicken gizzard lining 60g, patrinia scabiosaefolia 30g, chicken blood vine 30g, privet fruit 30g, eclipta prostrata 30g, poria cocos 45g, cimicifuga foetida 10g, agrimony 100g, agastache rugosa 15g, eupatorium fortunei 15g, and acorus tatarinowii 15g. The preparation method is the same as in Example 1, and the mixture is made into capsules, each weighing 0.5g. This comparative composition lacks the principal ingredient, deer antler, thus failing to achieve the core effects of warming the kidneys and strengthening yang, nourishing essence and blood, and disrupting the yin-yang balance of the formula.

[0035] Comparative Example 2 A traditional Chinese medicine composition comprises the following ingredients by weight: 45g ginseng leaves, 45g Ophiopogon japonicus, 10g Schisandra chinensis (processed with vinegar), 60g Rehmannia glutinosa, 20g deer antler, 20g turtle shell, 20g tortoise shell, 60g chicken gizzard lining, 30g Patrinia scabiosaefolia, 30g Spatholobus suberectus, 30g Ligustrum lucidum, 30g Eclipta prostrata, 10g Cimicifuga foetida, 100g Agrimonia pilosa, 15g Pogostemon cablin, 15g Eupatorium fortunei, and 15g Acorus tatarinowii. The preparation method is the same as in Example 1, and the mixture is made into capsules, each weighing 0.5g. This composition lacks the assistant herb Poria cocos, thus losing its calming, soothing, spleen-strengthening, and diuretic effects. It cannot effectively improve symptoms such as restlessness, insomnia, and forgetfulness, affecting the overall effect of the formula in nourishing the heart and calming the mind.

[0036] Comparative Example 3 A traditional Chinese medicine composition comprises the following ingredients by weight: 45g ginseng leaf, 45g ophiopogon japonicus, 10g vinegar-processed schisandra chinensis, 60g rehmannia glutinosa, 20g deer antler, 20g turtle shell, 20g tortoise shell, 30g chicken gizzard lining, 15g patrinia scabiosaefolia, 15g chicken blood vine, 15g privet fruit, 15g eclipta prostrata, 45g poria cocos, 5g cimicifuga foetida, 50g agrimony, 15g patchouli, 15g eupatorium fortunei, and 15g acorus tatarinowii. The preparation method is the same as in Example 1, and the mixture is made into capsules, each weighing 0.5g. In this comparative example, the dosage of adjuvant herbs is 50% of the original optimal ratio, which fails to achieve the auxiliary effects of strengthening the spleen and promoting digestion, invigorating blood circulation and unblocking collaterals, and replenishing qi and spirit. This results in a tonifying but stagnant effect, affecting absorption and overall conditioning efficacy.

[0037] Comparative Example 4 The treatment used commercially available, conventional kidney-tonifying traditional Chinese medicine (main ingredients: Rehmannia glutinosa, Cornus officinalis, Dioscorea opposita, Alisma plantago-aquatica, Poria cocos, Paeonia suffruticosa), in capsule form, 0.5g per capsule. Dosage and administration: Oral administration, 3 capsules each time, twice a day, taken with warm water after meals. This comparative study uses common kidney-tonifying traditional Chinese medicines in existing technologies, focusing only on tonifying the kidneys and lacking the effects of nourishing the heart, promoting blood circulation, and resolving dampness. Therefore, it cannot simultaneously improve multiple issues such as male fatigue, erectile function, and sperm quality.

[0038] Clinical observation examples To verify the therapeutic effects of the herbal composition of this invention, an 8-week clinical observation trial was conducted. 120 male patients with symptoms of kidney deficiency and heart deficiency were selected, aged 25–50 years, with an average age of 37.5 years. All patients clearly presented with fatigue, erectile dysfunction, and abnormal sperm quality (sperm density less than 15 × 10⁻⁶). 6 The number of patients with negative sperm counts ( / ml and progressive motility rate less than 32%) was excluded, along with patients with severe liver or kidney dysfunction, organic lesions of the reproductive system, and those allergic to the medicinal materials of this invention. 120 patients were randomly divided into a treatment group and a control group, with 60 patients in each group. There were no significant differences in age, disease duration, symptom severity, or other general information between the two groups (P>0.05), making them comparable.

[0039] Results: Patients in the treatment group took the capsules prepared in Example 1 of this invention, while patients in the control group took conventional kidney-tonifying traditional Chinese medicine (Comparative Example 4). Both groups took the medication continuously for 8 weeks, during which time they were prohibited from taking other kidney-tonifying or reproductive-improving drugs and health products, and maintained regular sleep and a reasonable diet. After 8 weeks, the improvement of symptoms and changes in sperm quality were observed in both groups. The results showed that the total effective rate in the treatment group was 78.0%, with 47 patients showing significant improvement in fatigue symptoms, and the effective rate for erectile function was 72.0%. Sperm density, motility, and abnormality rate all showed some improvement compared to before treatment. The total effective rate in the control group was 61.0%, and the improvement in all symptoms was lower in the control group than in the treatment group. The difference between the two groups was statistically significant (P<0.05). During the entire treatment observation period, no significant adverse reactions occurred in the treatment group, while 3 patients in the control group experienced mild abdominal distension and dry mouth. The symptoms were relieved after discontinuation of the medication, indicating that the traditional Chinese medicine composition of this invention has higher safety.

[0040] Comparative experiment: To further verify the rationality of the formulation of this invention and the synergistic effect of each medicinal material, comparative experiments were conducted between Examples 1-5 and Comparative Examples 1-3. Eighty male patients with symptoms of kidney deficiency and heart deficiency were randomly divided into eight groups of ten each. Each group received the corresponding formulation from the examples and comparative examples for eight consecutive weeks. Symptom improvement was observed, and the results are as follows: Examples 1-5: Symptoms such as fatigue, weakness, insomnia, and forgetfulness in all groups were improved to varying degrees. The effective rates of erectile function were: Example 1: 72%, Example 2: 69%, Example 3: 66%, Example 4: 68%, Example 5: 70%; the total effective rates were: Example 1: 78%, Example 2: 75%, Example 3: 72%, Example 4: 74%, Example 5: 76%; no obvious adverse reactions were observed in any group, with Example 1 (preferred formulation) showing the best overall effect.

[0041] Comparative Group 1: The kidney-tonifying effect was weak, the effective rate of erectile function was only 36%, the relief of fatigue symptoms was limited, and the total effective rate was 42%.

[0042] In the comparative group 2, the patients' symptoms such as insomnia and lethargy did not improve significantly, the effective rate of erectile function was 52%, the total effective rate was 54%, and some patients experienced mild indigestion.

[0043] Comparative group 3: Patients had normal digestion and absorption, the nourishing ingredients were easily stagnant, fatigue improvement was not significant, the effective rate of erectile function was 44%, and the total effective rate was 48%.

[0044] Comparative Group 4: Existing conventional kidney-tonifying Chinese patent medicines only have a certain improvement on symptoms of kidney deficiency, with limited overall conditioning effect. The total effective rate is 61%, the effective rate for erectile function is 58%, and no significant improvement on sperm quality was observed.

[0045] Experimental Conclusions: The traditional Chinese medicine compositions of Examples 1-5 of this invention, regardless of whether the preferred or range-based ratios are used, and regardless of the conventional dosage form, can achieve stable and mild conditioning effects with high safety. In contrast, Comparative Examples 1-3, due to the absence of key medicinal materials or abnormal dosages, all showed significantly reduced conditioning effects. Comparative Example 4, as a conventional kidney-tonifying drug, had a low overall efficacy rate and no significant improvement in sperm quality. This fully demonstrates that the formulation of this invention is scientifically sound and rationally formulated, with significant synergistic effects among the medicinal materials, and a better overall effect within the limited dosage range.

[0046] The embodiments described above are some, but not all, embodiments of the present invention. The detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is composed of the following Chinese medicinal materials in parts by weight: ginseng leaves 40-50 parts, ophiopogon japonicus 40-50 parts, schisandra chinensis (vinegar-processed) 8-12 parts, rehmannia glutinosa 55-65 parts, deer antler 18-22 parts, turtle shell 18-22 parts, tortoise shell 18-22 parts, chicken gizzard lining 55-65 parts, patrinia scabiosaefolia 25-35 parts, chicken blood vine 25-35 parts, privet fruit 25-35 parts, eclipta prostrata 25-35 parts, poria cocos 40-50 parts, cimicifuga foetida 8-12 parts, agrimony 95-105 parts, agastache rugosa 12-18 parts, eupatorium fortunei 12-18 parts, and acorus tatarinowii 12-18 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The ginseng leaves are in the form of 45 parts by weight.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight parts of Ophiopogon japonicus are 45 parts, and the weight parts of Schisandra chinensis are 10 parts.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight of the raw rehmannia root is 60 parts, and the weight of the deer antler, turtle shell, and tortoise shell is 20 parts each.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight of the chicken gizzard lining is 60 parts, and the weight of Patrinia scabiosaefolia, Spatholobus suberectus, Ligustrum lucidum, and Eclipta prostrata are all 30 parts.

6. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight parts of Poria cocos are 45 parts, the weight parts of Cimicifuga foetida are 10 parts, and the weight parts of Agrimonia pilosa are 100 parts.

7. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight parts of the patchouli, eupatorium, and calamus are all 15 parts.

8. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine composition comprises any one of claims 1 to 7, and pharmaceutically acceptable excipients; the traditional Chinese medicine preparation is prepared into granules, powders, oral liquids, pills, decoctions, or other pharmaceutically acceptable oral dosage forms by conventional pharmaceutical methods and with medically acceptable excipients.

9. The use of the traditional Chinese medicine composition according to any one of claims 1 to 7 in the preparation of a drug.

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