Kidney-tonifying, yang-strengthening and deficiency-tonifying traditional Chinese medicine composition for treating male erectile dysfunction and oligospermia and asthenospermia

Abstract

The invention provides a traditional Chinese medicine composition for tonifying kidney, strengthening yang and tonifying deficiency for treating male erectile dysfunction and oligospermia and asthenospermia. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 220 to 500 parts of semen cuscutae, 350 to 650 parts of bull penis, 230 to 480 parts of herba epimedii, 210 to 470 parts of herba cistanche, 190 to 450 parts of fructus corni, 180 to 420 parts of tortoise shell, 170 to 400 parts of antler, 160 to 350 parts of hippocampus, 160 to 280 parts of ginseng, 170 to 300 parts of rhizoma polygoni cuspidati, 210 to 380 parts of cortex eucommiae, 160 to 310 parts of okra seed, 130 to 250 parts of pericarpium citri reticulatae, 210 to 450 parts of caulis spatholobi, 250 to 360 parts of caulis sargentodoxae and 180 to 380 parts of rhizoma chuanxiong. The traditional Chinese medicine composition is used for treating male erectile dysfunction and insufficiency of kidney yang, impotence, spermatorrhea, premature ejaculation and sexual dysfunction in oligospermia and asthenospermia, can be used for symptomatically improving the weakness of male middle-aged and elderly people, has a long-term effect and stability after treatment, is superior to other treatment medicines and treatment technologies in modern medicine, and has a wide application prospect. Wide clinical value and commercial value are realized.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a kidney-tonifying, aphrodisiac, and deficiency-replenishing traditional Chinese medicine composition for treating male erectile dysfunction and oligospermia / asthenospermia.

[0002] This invention is a traditional Chinese medicine technique that achieves clinical cure for male erectile dysfunction and oligospermia / asthenospermia by enhancing and improving the body's constitution. It can also be used by middle-aged and elderly people with weak constitutions, as it is relatively mild and safe, providing comprehensive balancing and conditioning for patients. Technically, this invention can treat both erectile dysfunction and oligospermia / asthenospermia, while simultaneously improving the patient's constitution. Furthermore, the therapeutic effect is long-lasting and stable after treatment, demonstrating significant advantages compared to other drug treatment techniques in the same field of modern medicine. Background Technology

[0003] Erectile dysfunction (ED) in men refers to the persistent inability of the penis to achieve or maintain an erection sufficient for satisfactory sexual intercourse. In traditional Chinese medicine, this condition is called "yinwei," "jinwei," or "yangbuji."

[0004] From a modern medical perspective, the endothelial cells of the corpora cavernosa play a crucial role in regulating the tension of the smooth muscle in the corpora cavernosa, thus affecting penile erectile function. Nitric oxide (NO) and plasma endothelin-1 (ET-1), secreted by endothelial cells, are important active substances that regulate vasoconstriction and vasodilation. Decreased NO levels and increased ET-1 levels can cause abnormal relaxation of penile smooth muscle, thus leading to erectile dysfunction (ED).

[0005] In medical research, most scholars agree that testosterone plays a central and peripheral regulatory role in penile erection. Studies have shown that "changes in serum reproductive hormone (testosterone) levels are an important factor leading to erectile dysfunction (ED). Among various changes in reproductive hormones… it is one of the important factors causing ED and should be given clinical attention. In ED patients… the pathologically altered testes do not produce the expected levels of testosterone, leading to a vicious cycle in reproductive hormone secretion, ultimately causing hypothalamic-pituitary-gonadal axis dysfunction. Therefore, reproductive hormone level testing is very important for evaluating male sexual function, especially for the diagnosis and treatment of ED etiology" (Excerpt from: Journal of Radioimmunology, 2008, Vol. 21, No. 3; Analysis of Reproductive Hormone Levels in Male Patients with Erectile Dysfunction, Xintai Hospital Affiliated to Taishan Medical College (271200)). Zhang Yang); Furthermore, research indicates that "normal male sexual function depends on the coordinated action of numerous factors, including psychological, neurological, vascular, and endocrine factors… Most scholars agree that testosterone plays a central and peripheral regulatory role in penile erection, potentially regulating male sexual function through the central nervous system, sexual reflex arc, and penile cavernous tissue. It is generally believed that testosterone affects male sexual function by acting on central dopamine receptors. Penile erection is a complex process. Currently, nitric oxide is considered a key neurotransmitter for the production and maintenance of erection. Nitric oxide activates guanylate cyclase, leading to increased cyclic guanylate levels, which relaxes the smooth muscle within the cavernous body, allowing blood to flow in and resulting in penile erection. Nitric oxide is produced by the production of nitric oxide…" The expression of the penile nitric oxide synthase gene depends on sufficient levels of testosterone. Androgen deficiency can lead to loss of sexual interest, reduced frequency, amplitude, and duration of nocturnal erections… Testosterone not only indirectly promotes penile erection by enhancing libido and sexual arousal, but also plays an important role in penile tissue structure. Testosterone deficiency can cause a decrease in the number of smooth muscle cells in the corpora cavernosa, fibrous tissue hyperplasia, fat deposition, and reduced nitric oxide synthesis, all of which are important pathogenic causes of erectile dysfunction (ED). (Excerpt from: New Medicine, May 2009, Vol. 40, No. 5, New Advances in the Research on the Relationship between Testosterone and Metabolic Syndrome and Erectile Dysfunction, Department of Sexual Function Rehabilitation, Nanchang Andrology Hospital, 330001, Xu Ping and Tian Erpo)

[0006] Traditional Chinese medicine (TCM) summarizes erectile dysfunction as "inability to achieve or maintain an erection, and inability to sustain an erection for long periods." It attributes the cause to kidney deficiency, liver stagnation, damp-heat, blood stasis, and deficiency of qi and blood. The pathogenesis is often attributed to excessive depletion of kidney essence, leading to physical weakness and deficiency of both qi and blood, thus inducing symptoms such as "impotence, seminal emission, premature ejaculation, and decreased sexual function." This condition is one of the most common diseases among men in my country, not only affecting middle-aged and elderly men but also showing an increasing incidence among young adults.

[0007] Currently, ED treatment primarily uses phosphodiesterase type 5 (PDE5) inhibitors. However, these drugs all have short-term effects. While they are fast-acting and can solve the problem temporarily, they can cause side effects such as dizziness, headache, facial flushing, visual disturbances, nausea, and vomiting, increasing the psychological, economic, and physiological burden on patients. For patients, this type of medication is not conducive to physical recovery and cannot achieve the goal of improving the body's endocrine and nervous systems from a constitutional perspective. Therefore, using traditional Chinese medicine techniques to treat ED from a constitutional perspective is an urgent and much-needed technology.

[0008] With the accelerated pace of modern society, increased pressure from studies, life, and work, and factors such as widespread late marriage and childbearing or unhealthy lifestyles, the incidence of male infertility has risen significantly, and oligospermia and asthenospermia are common causes of male infertility. Modern medicine has not yet fully elucidated the etiology and pathogenesis of oligospermia and asthenospermia, and effective treatments are still lacking.

[0009] Although traditional Chinese medicine does not have specific disease names for oligospermia or asthenospermia, based on its clinical manifestations, it should be categorized under "infertility, cold sperm, and the desire for offspring." The *Suwen* (Plain Questions) states, "At eight years old, a man's kidney qi is strong, his hair grows and his teeth change. At sixteen, his kidney qi is abundant, his *tiankui* (menstrual blood) arrives, his essence overflows, yin and yang are in harmony, thus he can have children… At forty-eight, his liver qi declines, and his tendons cannot move. At forty-eight, his *tiankui* is exhausted, his essence is scarce, his kidneys decline, and his body reaches its limit." This indicates that the kidneys are the foundation of male fertility; abundant kidney qi and sufficient essence lead to fertility, while deficient kidney qi and scarce essence result in infertility. The *Jinkui Yaolue* (Essential Prescriptions of the Golden Chamber) states, "A man's pulse is floating, weak, and hesitant, indicating infertility, and his essence is cold." This considers this condition a form of consumptive disease. Kidney yang deficiency weakens the body's ability to nourish essence, leading to infertility. As can be seen from the above literature, ancient physicians had already explained the etiology and pathogenesis of this disease, believing that it was mostly a deficiency syndrome, with the disease location in the kidneys. The deficiency of yin and yang in the kidneys and the insufficiency of kidney essence led to this disease.

[0010] Conditions such as "impotence, premature ejaculation, and oligospermia / asthenospermia," after ruling out congenital deficiencies and infectious factors, fall under the category of "asthenia" in traditional Chinese medicine. They are all caused by physical weakness or excessive sexual activity that depletes vital energy, leading to deficiency of qi and blood, and depletion of kidney essence, ultimately resulting in "insufficient kidney essence and impotence." Therefore, oligospermia / asthenospermia and erectile dysfunction (ED) share a common origin, as both are rooted in the kidneys and have similar core pathogenesis.

[0011] In Traditional Chinese Medicine (TCM), these symptoms all fall under the category of "deficiency syndromes" (or "weakness syndromes"). TCM diagnosis focuses on qi and blood deficiency, and kidney qi insufficiency, with the underlying causes being kidney deficiency, liver stagnation, blood stasis, and dampness retention. Since the kidneys govern bones and nourish essence and blood, the core treatment principles are tonifying the kidneys and replenishing essence, nourishing yin and strengthening yang, and replenishing qi and blood. The treatment emphasizes addressing overall weakness and deficiency, supplemented by methods to soothe the liver, invigorate blood circulation, clear heat, and eliminate dampness.

[0012] During the research and development process, the technical team of this invention innovatively refined a treatment approach that combines kidney tonification, aphrodisiac, and deficiency-replenishing methods to improve and strengthen the patient's weak constitution. This approach integrates male erectile dysfunction and oligospermia / asthenospermia into a single treatment, incorporating family-inherited formulas to develop this invention. After years of practical clinical application, this invention has demonstrated long-lasting and stable therapeutic effects, exhibiting significant advantages compared to other drug treatments in the same field of modern medicine. Summary of the Invention

[0013] To address the shortcomings of existing technologies in the same field, this invention provides a traditional Chinese medicine composition for treating male erectile dysfunction and oligospermia / asthenospermia, which tonifies the kidneys, strengthens yang, and replenishes deficiency. The traditional Chinese medicine composition of this invention, by weight, consists of the following raw materials: Cuscuta chinensis 220-500 parts, Ox penis 350-650 parts, Epimedium brevicornu 230-480 parts, Cistanche deserticola 210-470 parts, Cornus officinalis 190-450 parts, Tortoise shell 180-420 parts, Deer antler 170-400 parts, Seahorse 160-350 parts, Ginseng 160-280 parts, Polygonum cuspidatum 170-300 parts, Eucommia ulmoides 210-380 parts, Okra seed 160-310 parts, Tangerine peel 130-250 parts, Spatholobus suberectus 210-450 parts, Sargentodoxa cuneata 250-360 parts, and Ligusticum chuanxiong 180-380 parts.

[0014] Furthermore, the preparation of the traditional Chinese medicine composition of the present invention is made from the following raw materials: Cuscuta chinensis, Ox penis, Epimedium, Cistanche deserticola, Cornus officinalis, Tortoise shell, Deer antler, Seahorse, Ginseng, Polygonum cuspidatum, Eucommia ulmoides, Okra seeds, Tangerine peel, Spatholobus suberectus, Sargentodoxa cuneata, Ligusticum chuanxiong, and glutinous rice sweet wine and glutinous rice liquor added during the preparation of the preparation.

[0015] Furthermore, the glutinous rice sweet wine and glutinous rice liquor added during the preparation of the traditional Chinese medicine composition of the present invention are characterized by using fresh glutinous rice that has been steamed and then brewed with yeast to remove the lees, resulting in non-inactivated glutinous rice sweet wine and glutinous rice liquor; the glutinous rice sweet wine has a sugar content of 8-12% and an alcohol content of 14-16% vol, and the glutinous rice liquor has an alcohol content of 56% vol.

[0016] To achieve the objective of this invention, this invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, which includes the following steps:

[0017] (1) According to the traditional Chinese medicine composition of the present invention, the following raw materials are pulverized into fine powder and mixed evenly after being proportioned according to their weight ratio: Cuscuta chinensis, Ox penis, Epimedium, Cistanche deserticola, Cornus officinalis, Tortoise shell, Deer antler, Seahorse, Ginseng, Polygonum cuspidatum, Eucommia ulmoides, Okra seeds, Tangerine peel, Spatholobus suberectus, Sargentodoxa cuneata, and Ligusticum chuanxiong.

[0018] (2) Weigh the above medicinal powder, soak it in a mixture of 1 part medicinal powder and 7 parts glutinous rice sweet wine by weight, seal the jar and store it at 18℃ for 10 days;

[0019] (3) Place the soaked medicine and medicine liquid in a medicine tank, heat it to 50°C and keep it for 3 hours, then heat it to 100°C and keep it for 1.5 hours, filter it to separate the medicine liquid from the medicine residue, and obtain the first extracted medicine liquid;

[0020] (4) After the first extraction and filtration, add an appropriate amount of pure water to the dregs, heat it to 100℃ in a medicine tank, keep it at 2.5 hours, filter it to separate the medicine liquid from the dregs, and obtain the medicine liquid extracted in the second extraction.

[0021] (5) After the second extraction and filtration, add an appropriate amount of pure water to the dregs, heat it to 100℃ in a medicine tank and keep it for 3 hours, then filter out the dregs to obtain the third extraction liquid.

[0022] (6) After mixing the three medicinal solutions, heat them to about 100°C to concentrate them until the medicinal solution is concentrated into a paste with a density of 1.4;

[0023] (7) Alternatively, the three solutions can be mixed and heated to about 100°C for concentration and spray drying into powder for later use as preparations suitable for various dosage forms such as capsules and tablets.

[0024] (8) The concentrated ointment with a density of 1.4 is mixed with glutinous rice liquor with an alcohol content of 56% vol to make a 40% vol medicinal liquor. It is then sealed and stored at room temperature for 30 days.

[0025] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for treating male erectile dysfunction and oligospermia, asthenospermia, and tonifying the kidney and strengthening yang, addressing kidney yang deficiency, impotence, premature ejaculation, and decreased sexual function, as well as symptomatically improving physical weakness in middle-aged and elderly men.

[0026] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of kidney-tonifying and aphrodisiac foods and health products for treating male erectile dysfunction, oligospermia, and asthenospermia, as well as for treating kidney yang deficiency, impotence, premature ejaculation, and decreased sexual function, and for symptomatic improvement of physical weakness in middle-aged and elderly men.

[0027] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of functional food and beverages for treating male erectile dysfunction and oligospermia, tonifying kidney yang and strengthening yang, addressing kidney yang deficiency, impotence, premature ejaculation, and decreased sexual function, as well as for symptomatic improvement of physical weakness in middle-aged and elderly men.

[0028] In traditional Chinese medicine theory, prescriptions for treating diseases are formulated using the "principal, assistant, adjuvant, and guide" principle. The pharmacological principle of the herbal composition of this invention is as follows: Cuscuta chinensis, ox penis, Epimedium, Cistanche deserticola, and Cornus officinalis are the principal herbs; tortoise shell, deer antler, seahorse, and ginseng are the assistant herbs; Polygonum cuspidatum, Eucommia ulmoides, and okra seeds are the adjuvant herbs; and tangerine peel, Spatholobus suberectus, Sargentodoxa cuneata, and Ligusticum chuanxiong are the guiding herbs. The combined effect of the "principal, assistant, adjuvant, and guide" principle achieves the therapeutic effect of tonifying the kidney and strengthening yang in treating male erectile dysfunction and oligospermia / asthenospermia, addressing kidney yang deficiency, impotence, premature ejaculation, and decreased sexual function, as well as symptomatically improving physical weakness in middle-aged and elderly men.

[0029] Cuscuta chinensis: It enters the liver, kidney and spleen meridians. It is sweet and warm in nature. Its functions and indications are to benefit the essence and marrow, nourish the liver and kidneys, consolidate the essence and reduce urination. It is used for impotence, seminal emission, soreness and weakness of the waist and knees, kidney deficiency and threatened abortion, and spleen and kidney deficiency diarrhea. Pharmacological studies have shown that it has protective activity against liver damage, yang-tonifying and sexual vitality-enhancing effects.

[0030] Ox penis: It is warm in nature and enters the kidney meridian. Its main functions are to warm and tonify kidney yang, and replenish essence and marrow. It is used for diseases caused by kidney yang deficiency and insufficient essence and blood, such as impotence, seminal emission, premature ejaculation, soreness of the waist and knees, dizziness and tinnitus.

[0031] Epimedium: It enters the liver and kidney meridians. It is sweet, pungent and warm in nature. Its functions and indications are to tonify kidney yang, strengthen tendons and bones and dispel wind and dampness. It is used for impotence, seminal emission, weakness of tendons and bones, rheumatic pain, numbness and contracture, and menopausal hypertension. Pharmacological studies have shown that it has aphrodisiac effects, promotes excessive semen secretion, stimulates sensory nerves, indirectly excites libido, and has antihypertensive effects.

[0032] Cistanche deserticola: It enters the kidney and large intestine meridians. It is sweet, salty and warm in nature. Its functions and indications are to tonify kidney yang and nourish essence and blood. It is used for impotence and infertility, soreness and weakness of the waist and knees, weakness of muscles and bones, and constipation due to intestinal dryness.

[0033] Cornus officinalis: It enters the liver and kidney meridians. It is sour, astringent and slightly warm in nature. Its functions and indications are to tonify the liver and kidneys, astringe essence and consolidate the body. It is used for dizziness and tinnitus, soreness and pain in the waist and knees, impotence and seminal emission, enuresis and frequent urination, metrorrhagia and leukorrhea, profuse sweating and collapse, internal heat and thirst, tonify vital energy, consolidate vital essence and strengthen the spirit. Its pharmacological effects also include antibacterial and anti-inflammatory effects.

[0034] In the herbal composition of this invention, Cuscuta chinensis, Ox penis, Epimedium, Cistanche deserticola, and Cornus officinalis are the principal herbs, which achieve the main effects of benefiting and protecting the liver, tonifying the kidney and strengthening yang to generate essence, benefiting essence and consolidating essence to fill the marrow, benefiting qi and blood to strengthen muscles and bones, and dispelling wind and dampness and anti-inflammation.

[0035] Tortoise shell: Enters the liver, kidney, and heart meridians. It is salty and neutral in nature. Its functions and indications are to nourish yin and subdue yang, tonify the kidneys and strengthen bones, nourish blood and tonify the heart. It is used to treat kidney yin deficiency, seminal emission, metrorrhagia, leukorrhea, fatigue, lower back pain and bone weakness, heart deficiency and forgetfulness, yin deficiency with wind-heat tidal fever, chronic dysentery and malaria, and delayed closure of the fontanelle in children.

[0036] Deer antler: It enters the liver, kidney and heart meridians. It is salty and warm in nature. Its functions and indications are to warm the kidney yang, strengthen tendons and bones, promote blood circulation and reduce swelling. It is used for impotence, seminal emission, blood stasis and swelling, cold pain in the waist and spine, carbuncles and sores. It can also treat acute mastitis.

[0037] Seahorse: Enters the liver and kidney meridians, is sweet and warm in nature, and is used to warm the kidneys and strengthen yang, reduce swelling and dissipate nodules. It is used for impotence, enuresis, infertility due to cold uterus, asthma due to kidney deficiency, injuries from falls, and masses and accumulations. Pharmacological studies have shown that it has sex hormone effects and anti-aging effects.

[0038] Ginseng: It enters the spleen, lung, and heart meridians. Its taste is sweet and slightly bitter, and its properties are neutral. Its functions and indications include greatly replenishing vital energy, restoring pulse and consolidating the body, tonifying the spleen and lungs, promoting body fluid production, and calming the mind. It is used for physical weakness and impending collapse, cold limbs and weak pulse, spleen deficiency and poor appetite, lung deficiency and cough, thirst due to fluid depletion, internal heat and thirst, chronic illness and emaciation, palpitations and insomnia, impotence and cold uterus, heart failure, and cardiogenic shock. Pharmacological studies have shown that it has an excitatory effect on the central nervous system, a direct effect on the myocardium and blood vessels, can promote the gonadal function of animals, can stimulate hematopoietic organs, and can improve anemia.

[0039] In the traditional Chinese medicine composition of this invention, tortoise shell, deer antler, seahorse, and ginseng are used as assistant ingredients to jointly promote blood circulation, nourish blood, tonify yin and yang, reduce swelling and dissipate nodules, stimulate gonadal function, replenish vital energy, and strengthen the body.

[0040] Polygonum cuspidatum: It enters the liver, gallbladder, and lung meridians. It is slightly bitter and slightly cold in nature. Its functions and indications are to dispel wind and dampness, disperse blood stasis and relieve pain, and stop cough and resolve phlegm. It is used for joint pain, damp-heat jaundice, amenorrhea, abdominal masses, burns, traumatic injuries, carbuncles and boils, and cough with excessive phlegm. Pharmacological studies have also shown that it has antibacterial and antiviral effects and is used to treat inflammation such as arthritis, chronic osteomyelitis, and pneumonia.

[0041] Eucommia ulmoides: Enters the liver and kidney meridians. Its properties are sweet and warm. Functions and indications: Tonifies the liver and kidneys, strengthens tendons and bones, and calms the fetus. Used for kidney deficiency causing lower back pain, weakness of tendons and bones, threatened miscarriage, fetal restlessness, and hypertension. Pharmacological studies have shown its effects on the pituitary-adrenal cortex system, non-specific immune function, humoral immunity, and cellular immunity.

[0042] Okra seeds: They enter the kidney, stomach, and bladder meridians. They are sweet and cold in nature. Their functions and indications include promoting diuresis, regulating menstruation, reducing swelling and detoxifying, treating urinary tract infections, edema and constipation, insufficient lactation, carbuncles, traumatic injuries, fractures, strengthening the spleen and stomach, and promoting tissue regeneration. They are an important medicine for inducing labor and promoting urination. Pharmacological effects also include aiding digestion, strengthening the stomach, and clearing liver toxins.

[0043] In the herbal composition of this invention, Polygonum cuspidatum, Eucommia ulmoides, and okra seeds are used as adjuvants to compensate for the deficiency of the principal and assistant herbs, and further promote the balance of the overall medicinal properties by tonifying the spleen, strengthening the stomach and clearing the liver.

[0044] Dried tangerine peel: Enters the spleen and lung meridians. Its properties are pungent, bitter, and warm. Its main functions are to regulate qi, strengthen the spleen, dry dampness, and resolve phlegm. It is used for chest and abdominal distension, poor appetite, vomiting and diarrhea, and cough with excessive phlegm. Modern pharmacological effects include inhibiting tumor cell proliferation, cardiovascular protection by lowering blood lipids, improving vascular endothelial function, gastrointestinal regulation by inhibiting gastric acid secretion, antioxidant and anti-inflammatory effects, scavenging free radicals and inhibiting the release of inflammatory factors, neuroprotection by inhibiting neuroinflammation, improving cognitive function, promoting bone health by promoting bone formation, and inhibiting bone resorption.

[0045] Chicken blood vine: Enters the liver and kidney meridians; bitter, sweet, and warm in nature. Functions and indications: Nourishes blood, invigorates blood circulation, unblocks meridians, regulates menstruation, and relieves pain. Used for irregular menstruation, amenorrhea, blood deficiency and chlorosis, numbness and paralysis, and rheumatic pain. Pharmacologically, it can dilate coronary arteries, inhibit platelet aggregation, and reduce the risk of thrombosis, thus improving cardiovascular and cerebrovascular diseases such as coronary heart disease and cerebral ischemia.

[0046] Large-leaved spatholobus: a plant of the genus Large-leaved spatholobus in the family Lardizabalaceae. It enters the liver and large intestine meridians. Its functions and indications are clearing heat and detoxifying, promoting blood circulation, dispelling wind and relieving pain, treating intestinal abscess and abdominal pain, sores caused by heat toxins, amenorrhea, dysmenorrhea, swelling and pain from falls and injuries, and rheumatic pain.

[0047] Chuanxiong (Ligusticum striatum): It enters the liver, gallbladder, and pericardium meridians. It is pungent and warm in nature. Its functions include promoting blood circulation and qi circulation, dispelling wind and relieving pain. Its pharmacological effects include increasing coronary artery blood supply, increasing cerebral artery blood flow, lowering blood pressure, and inhibiting platelet aggregation and thrombosis.

[0048] In the herbal composition of this invention, tangerine peel, chicken blood vine, large blood vine, and chuanxiong are used as guiding herbs to regulate qi, nourish blood, promote blood circulation, remove blood stasis, unblock meridians, dispel wind, relieve pain, reduce inflammation, and lower blood pressure. Together with the principal, assistant, and adjuvant herbs, the total medicinal power of the principal, assistant, adjuvant, and guiding herbs can reach the peripheral ends of various meridians, blood vessels, and nerves to achieve the effect of treating or improving the patient's condition.

[0049] Compared with the prior art, the beneficial effects and advantages of the present invention are as follows:

[0050] The technical advantages of this invention are that it is a pure traditional Chinese medicine formula, convenient to prepare and apply. It achieves its therapeutic effect by strengthening and improving the body's constitution. Relatively speaking, the medicinal properties are mild and safe, providing comprehensive balancing and conditioning for patients. It has a rapid effect, a relatively short treatment course and recovery time, and the effects are long-lasting and stable. For male erectile dysfunction and oligospermia / asthenospermia, it addresses kidney yang deficiency, impotence, premature ejaculation, and decreased sexual function by tonifying the kidneys and strengthening yang. It effectively improves the physical weakness of middle-aged and elderly men, making these conditions both preventable and treatable. Compared with modern medical technologies in the same field, it has significant advantages and possesses extremely high medical and socioeconomic value. Detailed Implementation

[0051] This invention provides a traditional Chinese medicine composition for treating male erectile dysfunction and oligospermia / asthenospermia, which tonifies the kidneys, strengthens yang, and replenishes deficiency. The composition, by weight, comprises the following ingredients: Cuscuta chinensis 220-500 parts, Ox penis 350-650 parts, Epimedium brevicornu 230-480 parts, Cistanche deserticola 210-470 parts, Cornus officinalis 190-450 parts, Tortoise shell 180-420 parts, Deer antler 170-400 parts, Seahorse 160-350 parts, Ginseng 160-280 parts, Polygonum cuspidatum 170-300 parts, Eucommia ulmoides 210-380 parts, Okra seed 160-310 parts, Tangerine peel 130-250 parts, Spatholobus suberectus 210-450 parts, Sargentodoxa cuneata 250-360 parts, and Ligusticum chuanxiong 180-380 parts.

[0052] The dodder seed, by weight, includes, but is not limited to, a point value of any one of 220 to 500 parts or a range between any two.

[0053] Among them, the bullwhip, when measured by weight, includes, but is not limited to, any one of the values ​​between 350 and 650 parts, or any range between two values.

[0054] Among them, the point value of Epimedium by weight is not limited to any one of 230 to 480 parts or any range between two.

[0055] The value of Cistanche deserticola by weight is not limited to, but includes, any one of the values ​​from 210 to 470 parts or any range between the two.

[0056] Among them, the point value of Cornus officinalis by weight is not limited to, but includes, any one of 190 to 450 parts or any range between two.

[0057] The tortoise shell, when measured by weight, includes, but is not limited to, a point value of any one of 180 to 420 parts or a range between any two.

[0058] Among them, the point value of deer antlers by weight is not limited to any one of 170 to 400 parts or any range between two.

[0059] The seahorse, measured by weight, includes, but is not limited to, a point value of any one of 160 to 350 parts or a range between any two.

[0060] Among them, the ginseng, by weight, includes but is not limited to the point value of any one of 160 to 280 parts or the range between any two.

[0061] Among them, the point value of Polygonum cuspidatum, calculated by weight, includes but is not limited to any one of 170 to 300 parts or any range between two.

[0062] Among them, the point value of Eucommia ulmoides by weight is not limited to any one of 210 to 380 parts or any range between two.

[0063] Among them, okra seeds, by weight, include but are not limited to a point value of any one of 160 to 310 parts or a range between any two.

[0064] The tangerine peel, measured by weight, includes, but is not limited to, any one of the values ​​between 130 and 250 parts, or any range between two values.

[0065] Among them, the value of chicken blood vine by weight is not limited to any one of 210 to 450 parts or any range between two.

[0066] Among them, the value of *Sargentodoxa cuneata* by weight is not limited to, but includes, any one of 250 to 360 parts or any range between two.

[0067] The value of Chuanxiong, measured by weight, includes, but is not limited to, any one of the values ​​in the range of 180 to 380 parts or any range between the two.

[0068] The following embodiments are used to further illustrate the core ideas and implementation methods of the present invention, and are not intended to limit the scope of protection of the present invention. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from the TCM theory and pharmacology of the present invention, and these improvements and modifications also fall within the scope of protection of the claims of the present invention. Therefore, the present invention is not limited to the embodiments shown herein, but can be applied to a wider range consistent with the pharmacology and novel features of TCM prescriptions disclosed herein. Unless otherwise defined, all techniques and TCM terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains.

[0069] Preparation of the Traditional Chinese Medicine Composition of the Present Invention in Examples

[0070] 220 parts of Cuscuta chinensis, 350 parts of Ox penis, 230 parts of Epimedium brevicornu, 210 parts of Cistanche deserticola, 190 parts of Cornus officinalis, 230 parts of tortoise shell, 170 parts of deer antler, 160 parts of seahorse, 160 parts of ginseng, 170 parts of Polygonum cuspidatum, 210 parts of Eucommia ulmoides, 160 parts of okra seeds, 130 parts of dried tangerine peel, 210 parts of Spatholobus suberectus, 250 parts of Sargentodoxa cuneata, and 180 parts of Ligusticum chuanxiong.

[0071] Preparation method:

[0072] (1) Weigh the above-mentioned Chinese herbal medicine pieces according to the weight ratio, mix them well, pulverize them into fine powder and mix them evenly;

[0073] (2) Soak the medicinal powder at a weight ratio of 1 part glutinous rice to 7 parts sweet rice wine, seal the container, and store it at 18°C ​​for 10 days.

[0074] (3) Place the soaked medicine and medicine liquid in a medicine tank, heat it to 50°C and keep it for 3 hours, then heat it to 100°C and keep it for 1.5 hours, filter it to separate the medicine liquid from the medicine residue, and obtain the first extracted medicine liquid;

[0075] (4) After the first extraction and filtration, add an appropriate amount of pure water to the dregs, heat it to 100℃ in a medicine tank, keep it at 2.5 hours, filter it to separate the medicine liquid from the dregs, and obtain the medicine liquid extracted in the second extraction.

[0076] (5) After the second extraction and filtration, add an appropriate amount of pure water to the dregs, heat it to 100℃ in a medicine tank and keep it for 3 hours, then filter out the dregs to obtain the third extraction liquid.

[0077] (6) After mixing the three medicinal solutions, heat them to about 100°C to concentrate them until the medicinal solution is concentrated into a paste with a density of 1.4;

[0078] (7) The concentrated ointment with a density of 1.4 was mixed with glutinous rice liquor with an alcohol content of 56% vol to make a 40% vol medicinal liquor, which was then sealed and stored at room temperature for 30 days.

[0079] (8) Alternatively, the three medicinal solutions can be mixed and heated to about 100°C for concentration and spray drying into powder for later use. Take 20 kg of the powder and mix it with distilled water at a weight ratio of 0.4:1 to prepare a pharmaceutical product. Name the pharmaceutical product "Bawang Xiongbian Liquid" and package it in 500 ml / bottle. Take 20 bottles of "Bawang Xiongbian Liquid" for "Example 1: Pharmacological efficacy test of the traditional Chinese medicine composition preparation "Bawang Xiongbian Liquid" of the present invention".

[0080] (9) After being sealed and stored for 30 days, the medicinal wine is opened and repackaged into 500-gram bottles. The medicinal wine is named "Bawang Xiongbian Wine". 1000 bottles of "Bawang Xiongbian Wine" are used in "Example 2: Clinical observation of the effects of the traditional Chinese medicine composition preparation "Bawang Xiongbian Wine" of the present invention".

[0081] The efficacy observation of the traditional Chinese medicine composition preparation of the present invention is divided into the following two examples:

[0082] Example 1: The efficacy of the traditional Chinese medicine composition preparation "Bawang Xiongbian Liquid" of the present invention was tested using animal experiments.

[0083] Example 2: Clinical observation of the effects of the traditional Chinese medicine composition preparation of the present invention, "Bawang Xiongbian Wine".

[0084] Example 1: Efficacy testing of the traditional Chinese medicine composition preparation "Bawang Xiongbian Liquid" of the present invention

[0085] The efficacy was assessed using SD rats. No pathological model was established in this experiment; SD rats that were allowed free access to food and water and grew naturally under the same conditions served as a blank control group.

[0086] Experimental objective: To observe the effects of "Bawang Xiongbian Liquid" on the physical condition and reproductive system development of SD rats during their normal growth cycle.

[0087] Forty male 4-week-old SPF-grade SD rats, weighing 100–105g, were purchased from the Shanghai Laboratory Animal Center. During the experiment, all rats were kept in an SPF-grade environment, separately caged, and given free access to standard pelleted feed and water. The environment was controlled with a temperature of 20–26℃, humidity of 40–70%, and a 12-hour light-dark cycle.

[0088] Forty rats were randomly divided into two groups of 20 each using a random number table method: the study group (drug administration group) and the control group (blank control group). This ensured that there were no statistically significant differences in the initial weight and health status of the two groups (P>0.05), thus guaranteeing the balance and objectivity of the experiment.

[0089] In the research group, each rat was administered Bawang Xiongbian Liquid twice daily by gavage, with 5 mL administered each time and an interval of 6 hours between the two administrations, for a total daily dosage of 10 mL. After administration, the rats had free access to food and water.

[0090] Control group: Rats were not given oral medication, but had free access to food and water, and all other feeding conditions were exactly the same as those of the study group.

[0091] The experiment lasted for 4 weeks, during which the growth, development and reproductive system of the rats were continuously observed.

[0092] The initial experimental period for rats was 4 weeks. After the 4-week experimental cycle was superimposed, the rats were 8 weeks old at the end of the experiment. On the last day of the experiment (day 57), the rats were fasted for 12 hours and then sacrificed and bled. The rats were then dissected to observe and compare the morphology of the prostate, testes (bilateral), and kidneys (bilateral) of the two groups of rats. At the same time, the mass of the above organs was measured and recorded, and the differences between the groups were analyzed.

[0093] Statistical analysis: SPSS 20.0 software was used to analyze the data. t-tests were used for continuous data. () indicates that count data are expressed using the χ² method. 2 The test showed that P < 0.05 was statistically significant.

[0094] Conclusion: Comparing the two groups of rats, the body weight and the quality of organs such as prostate, testis and kidneys in the study group were significantly higher than those in the control group, and the differences were statistically significant (P<0.05), as shown in Table 1.

[0095] Table 1. Comparison of physical condition of rats with a co-growth period of 8 weeks and an experimental period of 4 weeks ( )

[0096]

[0097] Experimental data showed that the body weight, as well as the organ weights of the prostate, bilateral testes, and bilateral kidneys, of the SD rats in the study group were significantly higher than those in the control group. This result confirms that oral administration of the traditional Chinese medicine composition "Bawang Xiongbian Liquid" of this invention can significantly enhance the physical condition of rats and has a positive promoting effect on the development of their kidneys and reproductive system organs.

[0098] Example 2: Clinical observation of the effects of the traditional Chinese medicine composition preparation of the present invention, "Bawang Xiongbian Wine".

[0099] The clinical efficacy observation of Example 2 was divided into two groups: Study Group 1 and Study Group 2;

[0100] Study Group 1: Clinical observation of the effects on erectile dysfunction (ED);

[0101] Study Group 2: Clinical efficacy observation for oligospermia and asthenospermia.

[0102] Example 2, Study Group 1: Clinical observation of the effects on erectile dysfunction (ED);

[0103] The clinical efficacy observation for erectile dysfunction (ED) was based on two data points: "serum testosterone data" and "medical history and physical examination findings".

[0104] From January 2023 to December 2024, in cooperation with medical institutions, 60 patients with erectile dysfunction (ED) were recruited as volunteer patients in case study group 1. The volunteer patients were required to drink "Bawang Xiongbian Wine" for 30 days and meet the conditions for follow-up. The diagnosis of all volunteer patients was based on the diagnosis of a tertiary hospital.

[0105] Inclusion criteria for Case 1 in Study Group 2 of Example 2:

[0106] (1) Willing to accept treatment with traditional Chinese medicine wine;

[0107] (2) Blood pressure <150 / 100 mmHg at the time of case selection and assessment;

[0108] (3) Has not received Western medicine hormone therapy;

[0109] (4) Male, aged 30-60;

[0110] (5) Sign the patient’s voluntary and informed consent form.

[0111] Exclusion criteria for Case 1 in Study Group 2 of Example 2:

[0112] (1) Allergic to alcohol and traditional Chinese medicine;

[0113] (2) Has a serious skin infection;

[0114] (3) Having an infectious disease of the reproductive system;

[0115] (4) Having gastrointestinal diseases such as gastrointestinal erosion or ulceration;

[0116] (5) Those who have had surgery on their reproductive organs (excluding circumcision)

[0117] (6) Individuals with severe functional impairments of the heart, liver, kidneys, etc., or those with autoimmune diseases;

[0118] (7) Comorbid acute complications of diabetes (diabetic ketoacidosis, diabetic nonketotic hyperosmolar syndrome, etc.).

[0119] (8) Severe chronic complications (such as diabetic nephropathy with nephrotic syndrome, diabetic lower extremity arterial occlusion, etc.).

[0120] (9) Individuals who have mental illness, psychological disorder, intellectual disability, etc. and are unable to cooperate in completing this test.

[0121] Example 2: Study Group 1 included 60 volunteers with erectile dysfunction (ED). 30 patients were ≤45 years old (aged 35–45 years, mean age 38.4±6.6 years), and 30 patients were >45 years old (aged 45–55 years, mean age 49.8±5.2 years). All patients met the medical diagnosis criteria for ED. Data on patient age, education level, and disease duration were analyzed using SPSS 20.0 software. There were no significant differences in general characteristics among the volunteers in Study Group 1 (P>0.05).

[0122] Clinical Protocol: In Example 2, Study Group 1 patients with erectile dysfunction (ED) were treated with "Bawang Xiongbian Wine" for one month. The medication was administered orally twice daily on an empty stomach, 50ml each time. Sexual activity was prohibited during the treatment period, but normal sexual activity could resume after the course of treatment. Serum testosterone levels were monitored every 10 days during the treatment. After a 30-day break following the end of the treatment, two data points were reviewed for clinical efficacy analysis: "serum testosterone levels" and "medical history and physical examination findings."

[0123] Data analysis: SPSS 20.0 software was used to analyze the data. () represents the mean ± standard deviation. Paired t-tests were used for within-group comparisons of testosterone data, and chi-square tests were used for within-group comparisons of erectile function improvement rates. 2 The difference was statistically significant (P<0.05).

[0124] Serum testosterone was collected according to the Chinese version of the LOH guidelines, "Guidelines for the Diagnosis and Treatment of Late-Onset Hypogonadism," combined with clinical experience. Blood samples were collected twice in the morning between 8:00 and 10:00 to record total testosterone levels. (Testosterone levels <290 ng / dL (<10 nmol / L) are considered low; 290–350 ng / dL is borderline low; >1000 ng / dL is considered high).

[0125] Clinical efficacy: Serum testosterone data of patients with erectile dysfunction (ED) in Study Group 1 of Example 2:

[0126] The serum testosterone data of patients in the ≤45-year-old group (30 cases) and the >45-year-old group (30 cases) who were treated with oral Bawang Xiongbian Wine were shown in Table 2 after a course of treatment, 30 days after stopping the medication and abstaining from sexual activity for 5 days (Note: serum testosterone values ​​were measured on the 36th day after stopping the medication).

[0127] Table 2. Serum testosterone data after oral administration of Bawang Xiongbian Wine and 30 days after discontinuation (n=60, ng / dL). )

[0128]

[0129] Conclusion: Serum testosterone levels in both groups showed a continuous upward trend throughout the treatment process, and remained high even 30 days after discontinuation of medication, without any decline. This indicates that the testosterone-boosting effect of "Bawang Xiongbian Wine" is long-lasting and stable, and not a short-term, transient effect. Intergroup comparison showed that the testosterone increase was slightly higher in the ≤45-year-old group than in the >45-year-old group, indicating that this medicinal wine has a significant effect on testosterone regulation in men of different ages.

[0130] Example 2: Study Group 1 patients with erectile dysfunction (ED) – “Medical history and physical examination findings” data:

[0131] The ≤45-year-old group (30 cases) and the >45-year-old group (30 cases) were treated with oral Bawang Xiongbian Wine for one month. After the course of treatment, the medication was stopped for 30 days, followed by 5 days of abstinence, and a follow-up examination of "medical history and physical signs" was conducted (Note: follow-up examination was conducted on the 36th day after stopping the medication). The data on the improvement of erectile dysfunction are shown in Table 3 below.

[0132] Table 3. Data on improvement in erectile dysfunction after treatment (n=60%, %)

[0133]

[0134] Conclusion: Overall improvement in erectile dysfunction (ED) in the two groups: the total improvement rate was 96.7% (29 / 30) in the ≤45-year-old group and 93.3% (28 / 30) in the >45-year-old group. Subtype improvement: Nocturnal erectile dysfunction showed the highest improvement rate, reaching 100% (30 / 30) in the ≤45-year-old group and 96.7% (29 / 30) in the >45-year-old group. Reflex and psychogenic erectile dysfunction showed slightly lower improvement rates, both at 93.3% (28 / 30) in the ≤45-year-old group and 90% (27 / 30) in the >45-year-old group. Analysis of the data on erectile dysfunction improvement in study group 1 of Example 2 demonstrates that the technology of this invention significantly improved relevant indicators in 60 patients with erectile dysfunction (ED) in both the ≤45-year-old and >45-year-old groups. The use of "Bawang Xiongbian Jiu" medicinal wine has a significant therapeutic effect on patients' erectile function.

[0135] As explained above, hormone level testing is a very important indicator for evaluating male sexual function, especially for the diagnosis and treatment of erectile dysfunction (ED).

[0136] In Example 2, patients with erectile dysfunction (ED) in study group 1 were treated with Bawang Xiongbian Wine for one month. After the course of treatment was completed and the medication was stopped for 30 days, the data in Tables 2 and 3 showed that the patients' testosterone secretion rate increased significantly, and the three physiological erectile functions of reflex erection, psychogenic erection and nocturnal erection were significantly improved.

[0137] Based on the two data points ("serum testosterone data" and "medical history and physical examination findings") from the follow-up study group 1 of Example 2 (60 volunteers with erectile dysfunction (ED), the results were as follows: In the group ≤45 years old (30 cases), the serum testosterone level reached 676±21.3 ng / dL, an increase of 48.9%, with a 100% improvement rate in testosterone secretion and a total ED improvement rate of 96.7%; In the group >45 years old (30 cases), the serum testosterone level reached 602±19.6 ng / dL, an increase of 46.1%, with a 100% improvement rate in testosterone secretion and a total ED improvement rate of 93.3%.

[0138] Therefore, this invention demonstrates that the technology of the present invention has an improving effect on promoting the natural secretion of testosterone in the body, and has a long-lasting and stable effect on regulating serum testosterone levels. Furthermore, the increase in testosterone levels is positively correlated with the improvement of erectile function. Thus, the technology of the present invention has a good therapeutic effect on male erectile dysfunction.

[0139] Example 2, Study Group 2: Clinical efficacy observation for oligospermia and asthenospermia;

[0140] From January 2023 to December 2024, in cooperation with medical institutions, 60 patients with oligospermia and asthenospermia were recruited as volunteers in Study Group 2 of Example 2. The volunteers were required to drink "Bawang Xiongbian Wine" for 30 days and meet the conditions for follow-up. The diagnosis of all volunteers was based on the diagnosis of a tertiary hospital.

[0141] According to the "Guidelines for the Diagnosis and Treatment of Male Infertility in China (2023 Edition)" (fully adopting the WHO 5th / 6th edition criteria), oligospermia is defined as a sperm concentration <15 × 10⁻⁶. 6 / mL (15 million / ml); Asthenospermia: sperm density ≥15×10 6 A sperm motility index ( / mL) of less than 32% with other parameters being normal or essentially normal can be diagnosed as asthenospermia.

[0142] Inclusion criteria for Case 2 in Study Group 2 of Example 2:

[0143] (1) Willing to undergo treatment with traditional Chinese medicine;

[0144] (2) Blood pressure <150 / 100 mmHg at the time of case selection and assessment;

[0145] (3) Has not received Western medicine hormone therapy;

[0146] (4) Male, aged 30-45;

[0147] (5) Sign the patient’s voluntary and informed consent form.

[0148] Exclusion criteria for Case 2 in Study Group 2 of Example 2:

[0149] (1) Allergic to alcohol and traditional Chinese medicine;

[0150] (2) Has a serious skin infection;

[0151] (3) Individuals with reproductive system infections;

[0152] (4) Having gastrointestinal diseases such as gastrointestinal erosion or ulceration;

[0153] (5) Those with congenital azoospermia, or testicular malformation or occult testes;

[0154] (6) Those who have had surgery on their reproductive organs (excluding circumcision);

[0155] (7) Individuals with severe functional impairments of the heart, liver, kidneys, etc., or those with autoimmune diseases;

[0156] (8) Comorbid acute complications of diabetes (diabetic ketoacidosis, diabetic nonketotic hyperosmolar syndrome, etc.).

[0157] (9) Severe chronic complications (such as diabetic nephropathy with nephrotic syndrome, diabetic lower extremity arterial occlusion, etc.).

[0158] (10) Individuals who have mental illness, psychological disorder, intellectual disability, etc. and are unable to cooperate in completing this test.

[0159] Example 2: Study group 2 included 60 volunteers with oligospermia and asthenospermia. One group consisted of 20 patients with oligospermia (aged 30–45 years, mean age 38.7±5.4 years); another group consisted of 20 patients with asthenospermia (aged 30–45 years, mean age 39.7±4.1 years); and yet another group consisted of 20 patients with oligospermia and asthenospermia (aged 30–45 years, mean age 38.5±4.3 years). All patients met the medical diagnostic criteria for oligospermia and asthenospermia. Patient age, education level, and disease duration were analyzed using SPSS 20.0 software. There were no significant differences in general characteristics between the two groups (P>0.05).

[0160] Clinical Protocol: In Example 2, study group 2 patients with oligospermia and asthenospermia underwent oral treatment with "Bawang Xiongbian Wine" for one month. The medicine was taken twice daily on an empty stomach before meals, 50ml each time. Sexual activity was prohibited during the treatment period, but was lifted after the treatment course. A follow-up examination was conducted 30 days after the end of the treatment course, with abstinence required for 5 days prior to the follow-up examination. Semen was collected by masturbation 5 days later (Note: sperm was collected on day 36 after stopping the medication). Routine analysis of semen volume, sperm concentration, and progressive motility (PR) was performed.

[0161] Data were analyzed using SPSS 20.0 software. Paired t-tests were used for within-group comparisons, and P < 0.05 was considered statistically significant. Data before and after treatment for oligospermia and asthenospermia are shown in Table 4.

[0162] Table 4. Data before and after treatment for oligospermia and asthenospermia (n=60)

[0163]

[0164] Semen volume, sperm density, and sperm motility are the core diagnostic indicators for oligospermia and asthenospermia. Oligospermia can be diagnosed mainly based on sperm concentration; sperm motility includes progressive motility (PR) and non-progressive motility (NP), among which only progressive motility (PR) sperm can directly affect fertility, so the proportion of progressive motility (PR) sperm is a key indicator for diagnosing asthenospermia.

[0165] Clinical data analysis: Data from 30 days after the end of treatment showed that in the oligospermia group, the improvement rates of semen volume, sperm concentration, and sperm motility were 95%, 98%, and 97%, respectively, with increases of 50%, 220.7%, and 103.4%. In the asthenospermia group, the improvement rates were 90%, 95%, and 98%, with increases of 34.6%, 54.8%, and 117.6%. In the oligospermia and asthenospermia groups, the improvement rates were 88%, 96%, and 95%, with increases of 55.6%, 237.2%, and 124.4%. Compared with pre-treatment levels, semen volume, sperm concentration, and progressive motility (PR) sperm motility significantly increased in all three groups. Post-treatment, all relevant indicators met the reference standards specified in the WHO Semen Manual, 5th / 6th edition.

[0166] Conclusion: Bawang Xiongbian Wine can significantly improve semen quality in patients with oligospermia, asthenospermia, and oligospermia-asthenospermia, with improvement rates ranging from 88% to 98% and enhancement rates from 34.6% to 237.2%, demonstrating definite clinical efficacy. Based on the data in Table 4 and referring to the World Health Organization's "Laboratory Manual for the Examination and Processing of Human Semen" (5th / 6th edition) and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," the clinical cure standard is defined as a sperm concentration ≥15×10⁻⁶ in patients with oligospermia after treatment. 6 / mL, after treatment, the progressive motility (PR) rate of sperm in patients with asthenospermia was ≥32%; the criteria for significant effect were an increase of ≥50% in sperm concentration and ≥25% in progressive motility (PR) rate in patients with asthenospermia, but not reaching the normal standard; the criteria for effectiveness were an increase of ≥15% in sperm concentration and ≥5% but <25% in progressive motility (PR) rate in patients with asthenospermia; and the criteria for ineffectiveness were that the increase in sperm concentration and progressive motility (PR) rate did not meet the effective standard, or the indicators showed no improvement or even decreased. Based on the above criteria, the data in Table 4 confirm that the oligospermia group, asthenospermia group, and oligospermia-asthenospermia group all achieved clinical cure efficacy.

[0167] In the implementation of the present invention, the drug efficacy test of SD rats in Example 1 confirmed that the present invention has the effect of improving the physical condition of SD rats and promoting the development of the reproductive system of sexual organs.

[0168] In the implementation of this invention, the clinical effects in Example 2 are all follow-up results after the volunteers completed the treatment course and stopped medication for 30 days, rather than the immediate effects during medication. This is the core advantage, proving that the efficacy of this invention remains long-lasting and stable after medication is stopped.

[0169] From the perspective of traditional Chinese medicine theory, the technology of this invention does have the effect of tonifying the kidneys, strengthening yang, and replenishing deficiency in the embodiments. It achieves the overall treatment goal by improving physical weakness and enhancing the patient's constitution. It also has the effect of enhancing and improving the constitution of middle-aged and elderly people with corresponding symptoms who are weak and frail.

[0170] Therefore, the clinical effect of this invention is to tonify the kidneys, strengthen yang, and replenish deficiencies, thereby improving physical condition and treating erectile dysfunction (ED) and oligospermia and asthenospermia. It also has the effect of improving and strengthening the physical condition of middle-aged and elderly people who are weak and frail and meet the corresponding symptoms.

[0171] In summary, the traditional Chinese medicine composition provided by this invention, with its excellent kidney-tonifying, aphrodisiac, and deficiency-replenishing effects, can effectively improve the patient's constitution and has excellent therapeutic effects on male erectile dysfunction and oligospermia / asthenospermia. Furthermore, the therapeutic effect is long-lasting and stable after discontinuation of the medication. Compared with other drug treatment technologies in the same field of modern medicine, this invention has significant advantages.

[0172] This invention can be widely applied in the fields of medicine, functional food and beverage, and health care products.

[0173] The embodiments of the present invention have been described in detail above, but the present invention is not limited to the described embodiments. Based on the above description of the present invention, and according to ordinary technical knowledge and common practice in the art, it will be obvious to those skilled in the art that various other changes and modifications can be made to these embodiments without departing from the basic technical concept of the present invention, and these changes still fall within the protection scope of the present invention.

Claims

1. This invention provides a traditional Chinese medicine composition for treating male erectile dysfunction and oligospermia / asthenospermia, which tonifies the kidneys, strengthens yang, and replenishes deficiency. The traditional Chinese medicine composition of this invention is composed of the following raw materials in parts by weight: Cuscuta chinensis 220–500 parts, Ox penis 350–650 parts, Epimedium brevicornu 230–480 parts, Cistanche deserticola 210–470 parts, Cornus officinalis 190–450 parts, Tortoise shell 180–420 parts, Deer antler 170–400 parts, Seahorse 160–350 parts, Ginseng 160–280 parts, Polygonum cuspidatum 170–300 parts, Eucommia ulmoides 210–380 parts, Okra seed 160–310 parts, Tangerine peel 130–250 parts, Spatholobus suberectus 210–450 parts, Sargentodoxa cuneata 250–360 parts, Ligusticum chuanxiong 180–380 parts.

2. The traditional Chinese medicine composition as described in claim 1, in the preparation of the formulation, is characterized in that... The traditional Chinese medicine composition is prepared from the following raw materials: Cuscuta chinensis, Ox penis, Epimedium, Cistanche deserticola, Cornus officinalis, Tortoise shell, Deer antler, Seahorse, Ginseng, Polygonum cuspidatum, Eucommia ulmoides, Okra seeds, Tangerine peel, Spatholobus suberectus, Sargentodoxa cuneata, Ligusticum chuanxiong, and glutinous rice sweet wine and glutinous rice liquor added during the preparation of the preparation.

3. The traditional Chinese medicine composition as described in claims 1-2, characterized in that the glutinous rice sweet wine and glutinous rice spirit added during the preparation process are, The non-deactivated glutinous rice sweet wine and glutinous rice liquor are made by steaming fresh glutinous rice and then brewing it with yeast. The glutinous rice sweet wine has a sugar content of 8-12% and an alcohol content of 14-16% vol. The glutinous rice liquor has an alcohol content of 56% vol.

4. The preparation of the traditional Chinese medicine composition according to claims 1 to 3 may be in the form of medicinal wine, liquid, powder, tablet, pill, capsule, ointment, or jelly.

5. The formulation of the traditional Chinese medicine composition according to claims 1 to 4, characterized in that... A preparation made by adding other excipients or auxiliary ingredients acceptable for pharmaceuticals or food to a drug active pharmaceutical ingredient, a powdered active pharmaceutical ingredient, a concentrated extract of an active pharmaceutical ingredient, or a drug extracted from an active pharmaceutical ingredient through a certain technology and process.

6. The formulation of the traditional Chinese medicine composition according to claims 1 to 5, characterized in that... The aforementioned traditional Chinese medicine composition is a preparation specifically used in the treatment of male erectile dysfunction and oligospermia / asthenospermia, specifically for tonifying kidney yang, invigorating yang, treating impotence, premature ejaculation, and decreased sexual function, as well as for symptomatic improvement of physical weakness in middle-aged and elderly men.

7. The formulation of the traditional Chinese medicine composition according to claims 1 to 5, characterized in that... The Chinese herbal composition is a preparation specifically used for tonifying the kidney and strengthening yang in men with erectile dysfunction and oligospermia, as well as for treating kidney yang deficiency, impotence, premature ejaculation, and decreased sexual function. It is also used in special medical foods, beverages, and health products to symptomatically improve physical weakness in middle-aged and elderly men.

8. The formulation of the traditional Chinese medicine composition according to claims 1 to 5, characterized in that... The Chinese herbal composition is a preparation specifically used in the treatment of male erectile dysfunction and oligospermia, as well as in the context of tonifying the kidney and strengthening yang, addressing kidney yang deficiency, impotence, premature ejaculation, and decreased sexual function, and in the symptomatic improvement of physical weakness in middle-aged and elderly men.

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