Traditional Chinese medicine composition and application thereof in preparation of erectile dysfunction improving drugs

Abstract

This invention discloses a traditional Chinese medicine composition and its application in the preparation of a drug for improving erectile dysfunction. By weight, it comprises the following components: 9-30 parts of Rhodiola rosea, 10-40 parts of Astragalus membranaceus (processed), 10-30 parts of Codonopsis pilosula, 9-20 parts of Angelica sinensis, 10-20 parts of Salvia miltiorrhiza, 10-30 parts of Paeonia lactiflora, 10-30 parts of Lycium barbarum, 9-30 parts of Epimedium brevicornu, 10-20 parts of Achyranthes bidentata, 3-12 parts of Eupolyphaga sinensis, 3-10 parts of Eupolyphaga sinensis, 10-20 parts of Campsis grandiflora, 10-20 parts of Eucommia ulmoides, and 10-20 parts of Cistanche deserticola. This invention aims to improve the treatment system of "invigorating qi and blood, tonifying the kidney and unblocking the collaterals". By introducing the methods of tonifying the kidney and replenishing essence and clearing away blood stasis, it enhances the regulatory effect on the microcirculation environment inside the corpus cavernosum of the penis and provides targeted repair for the damaged corpus cavernosum tissue structure and biomechanical properties. This effectively improves the clinical applicability of this formula for patients with organic erectile dysfunction or those with kidney essence deficiency and a tendency for prolonged illness to affect the collaterals. From a pathophysiological perspective, it further enriches the intervention methods for erectile dysfunction and its related pathological links.

Description

Technical Field

[0001] This invention relates to the technical field of traditional Chinese medicine preparations, particularly to traditional Chinese medicine compositions and their application in the preparation of drugs for improving erectile dysfunction. Background Technology

[0002] Erectile dysfunction (ED) is considered one of the major health problems for men due to changes in the spectrum of human diseases and the acceleration of aging, which greatly affects the quality of life of patients.

[0003] Currently, the first-line drug for the clinical treatment of erectile dysfunction (ED) is a phosphodiesterase type 5 inhibitor (PDE-5-i). However, the long-term efficacy of PDE5-i in the treatment of ED still needs further verification. It has not yet achieved the desired effect in the treatment of some organic ED cases, and there are problems such as a high relapse rate after drug discontinuation and the need for repeated medication.

[0004] While natural medicines, especially traditional Chinese medicine compound formulas, may not achieve the remarkable clinical effects of synthetic drugs in in vitro experiments when considering a single pathological process, the overall comprehensive efficacy of traditional Chinese medicine compound formulas, which involve multiple components, multiple targets, and multiple processes, is unmatched by synthetic drugs. In particular, the external treatment of erectile dysfunction with traditional Chinese medicine has a very long history and clear efficacy.

[0005] The applicant previously independently developed the Hongjing No. 1 formula, which consists of nine traditional Chinese medicines: Rhodiola rosea, Astragalus membranaceus (processed), Codonopsis pilosula (fried), Angelica sinensis, Salvia miltiorrhiza, Paeonia lactiflora, Lycium barbarum, Epimedium brevicornu, and Achyranthes bidentata. Animal experimental data confirmed that this formula has a clear effect on improving erectile dysfunction in rats with bilateral cavernous nerve injury. To verify its clinical application value, the applicant further selected five comprehensive tertiary-level hospitals nationwide to conduct multi-center clinical trials. The trial results fully corroborated the efficacy of this formula in improving erectile dysfunction in clinical settings. However, the Hongjing No. 1 formula is limited to symptom relief of erectile dysfunction and does not delve into and target the core pathogenesis of the disease, thus failing to fundamentally repair the physiological regulatory mechanisms of the body's internal organs and reproductive system. Summary of the Invention

[0006] The purpose of this invention is to solve the problems in the prior art by proposing a traditional Chinese medicine composition and its application in the preparation of drugs for improving erectile dysfunction, which can solve the above problems.

[0007] To achieve the above objectives, the present invention proposes a traditional Chinese medicine composition comprising, by weight, the following components: 9-30 parts of Rhodiola rosea, 10-40 parts of processed Astragalus membranaceus, 10-30 parts of Codonopsis pilosula, 9-20 parts of Angelica sinensis, 10-20 parts of Salvia miltiorrhiza, 10-30 parts of Paeonia lactiflora, 10-30 parts of Lycium barbarum, 9-30 parts of Epimedium brevicornu, 10-20 parts of Achyranthes bidentata, 3-12 parts of Eupolyphaga sinensis, 3-10 parts of Eupolyphaga sinensis, 10-20 parts of Campsis grandiflora, 10-20 parts of Eucommia ulmoides, and 10-20 parts of Cistanche deserticola.

[0008] As a preferred option, the product comprises the following components by weight: 15 parts Rhodiola rosea, 20 parts Astragalus membranaceus (processed), 15 parts Codonopsis pilosula, 12 parts Angelica sinensis, 15 parts Salvia miltiorrhiza, 15 parts Paeonia lactiflora, 15 parts Lycium barbarum, 10 parts Epimedium brevicornu, 12 parts Achyranthes bidentata, 10 parts Eupolyphaga sinensis, 9 parts Eupolyphaga sinensis, 15 parts Campsis grandiflora, 15 parts Eucommia ulmoides, and 15 parts Cistanche deserticola.

[0009] Among them, Rhodiola saera (Prain) Fu, a plant of the genus Rhodiola in the family Crassulaceae, is used medicinally in its whole form. It has the effects of tonifying qi and promoting blood circulation, benefiting intelligence and nourishing the heart, clearing and reducing lung heat, astringing and stopping bleeding, and dispersing blood stasis and reducing swelling. It is used for qi deficiency and weakness; aversion to cold after illness; shortness of breath and fatigue; cough due to lung heat; hemoptysis; leukorrhea and diarrhea; traumatic injuries; burns; and can also treat neurosis and altitude sickness.

[0010] Astragalus is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., belonging to the Fabaceae family. It has the effects of tonifying qi and strengthening the exterior, promoting diuresis and eliminating toxins, draining pus, and promoting tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, qi sinking, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, carbuncles that are difficult to heal, chronic ulcers that do not heal, anemia and chlorosis, internal heat and thirst; qi and blood stasis, and hemiplegia due to stroke.

[0011] Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. modesta (Nannf.) L. Shen, or Codonopsis tangshen Oliv. are all plants belonging to the Campanulaceae family. Codonopsis pilosula has the effects of tonifying the middle energizer and replenishing qi, strengthening the spleen and benefiting the lungs. It is used for symptoms such as spleen and lung deficiency, shortness of breath and palpitations, poor appetite and loose stools, wheezing and coughing due to deficiency, and internal heat and thirst.

[0012] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant in the Apiaceae family. It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, constipation due to intestinal dryness, rheumatic pain, traumatic injuries, carbuncles and sores. Wine-processed Angelica sinensis promotes blood circulation and regulates menstruation; it is used for amenorrhea and dysmenorrhea, rheumatic pain, and traumatic injuries.

[0013] Danshen is the dried root and rhizome of Salvia miltiorrhiza Bunge., a plant in the Lamiaceae family. It has the effects of removing blood stasis and relieving pain, promoting blood circulation and regulating menstruation, and clearing the heart and relieving irritability. It is used for various diseases caused by blood stasis and obstruction of collaterals, irregular menstruation, amenorrhea and dysmenorrhea, abdominal masses, chest and abdominal pain, hot arthralgia, sores and swelling, irritability and insomnia; hepatosplenomegaly, and angina pectoris.

[0014] White peony root is the dried root of Paeonia lactiflora Pal., a plant in the Ranunculaceae family. It has the effects of calming the liver and relieving pain, nourishing blood and regulating menstruation, and astringing yin and stopping sweating. It is used for headaches and dizziness, hypochondriac pain, abdominal pain, limb spasms, blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, and night sweats.

[0015] Goji berries are the dried, ripe fruit of Lycium barbarum L., a plant in the Solanaceae family. They have the effects of nourishing the liver and kidneys, benefiting essence and improving eyesight; they are used for deficiency of essence and blood, soreness of the waist and knees, dizziness and tinnitus, internal heat and thirst, blood deficiency and chlorosis, and blurred vision.

[0016] Epimedium (also known as horny goat's eye) is a perennial herb with the scientific name Epimedium brevicornu Maxim. It has the effects of tonifying the kidneys, replenishing essence and qi, strengthening muscles and bones, and tonifying the kidneys and strengthening yang. Clinically, it is often used to treat male impotence, spermatorrhea, urinary incontinence, and female infertility.

[0017] Achyranthes bidentata is the dried root of Cyathula officinalis Kuan, a plant in the Amaranthaceae family. It has the effects of removing blood stasis and promoting menstruation, relieving joint pain, and promoting urination. It is used for amenorrhea, retained placenta, joint pain, foot weakness and muscle spasm, hematuria, and injuries from falls.

[0018] Nine-fragrant insect is the dried whole insect of the nine-fragrant insect of the family Stink bug; it has the effects of regulating qi and relieving pain, warming the middle and assisting yang; it is used for symptoms such as kidney deficiency and impotence, cold stomach and abdominal distension and pain, liver and stomach qi pain, soreness of the waist and knees, and chest pain caused by mental unhappiness. It is effective when taken with other tonics.

[0019] Ground beetle is the dried female body of Eupolyphagasinensis Walker or Steleophagaplancyi (Boleny), both belonging to the family Blattodea. It has the effects of removing blood stasis, breaking up accumulations, clearing the meridians, promoting lactation, and tonifying the kidneys. It is mainly used to treat arthritis, lumbago, sprains and bruises, fractures, amenorrhea due to blood stasis in women, and abdominal pain due to blood stasis.

[0020] The flowers and roots of Campsis grandiflora (Thunb.) K.Schum. or Campsis radicans (L.) Seem., belonging to the Bignoniaceae family, are dried. The flowers have the effects of cooling the blood, removing blood stasis, and dispelling wind; they are used for irregular menstruation, amenorrhea, postpartum mastitis, urticaria, itchy skin, and acne. The roots have the effects of promoting blood circulation, removing blood stasis, detoxifying, and reducing swelling; they are used for rheumatic pain, traumatic injuries, fractures, dislocations, and acute gastroenteritis.

[0021] Eucommia ulmoides is the dried bark of the Eucommia ulmoides plant (Eucommia ulmoides Oliver). It has the effects of tonifying the liver and kidneys, strengthening tendons and bones, and calming the fetus. It is used for liver and kidney deficiency, soreness and pain in the lower back and knees, weakness of tendons and bones, dizziness, bleeding during pregnancy, and restless fetal movement.

[0022] Cistanche deserticola is the dried, fleshy stem with scales and leaves of Cistanche deserticola (Cistanche dermatitis Y.C.Ma), a plant of the Orobanchaceae family. It has the effects of tonifying kidney yang, nourishing essence and blood, and moistening the intestines to relieve constipation. It is used for impotence, infertility, soreness and weakness of the waist and knees, weakness of muscles and bones, and constipation due to intestinal dryness.

[0023] As a preferred embodiment, the product also includes the following components by weight: 3-10 parts centipede, 3-12 parts leech, 10-30 parts tribulus, 9-20 parts bupleurum, 10-20 parts yangqi stone, and 9-20 parts morinda root.

[0024] As a preferred option, the product also includes the following components by weight: 5 parts centipede, 10 parts leech, 20 parts tribulus, 12 parts bupleurum, 12 parts yangqi stone, and 15 parts morinda root.

[0025] Leeches, specifically the dried bodies of leeches (Whitmania pigra Whitman), leeches (Hirudonipponica Whitman), or willow-leaf leeches (Whitmania acranulata Whitman), have the effects of breaking up blood stasis, removing blood stasis, and promoting menstruation; they are used for abdominal masses, amenorrhea due to blood stasis, and injuries from falls.

[0026] Centipede is the dried body of the giant centipede (Scolopendra subspinipesmutilans L. Koch), an animal of the Scolopendra family. It has the effects of calming wind and relieving spasms, dispelling toxins and resolving lumps, and clearing the meridians and relieving pain. It is used for infantile convulsions, spasms, facial paralysis due to stroke, hemiplegia, tetanus, stubborn rheumatism, impotence, sores, scrofula, and snake bites.

[0027] Tribulus terrestris L., a plant in the family Tribulaceae, is a dried, mature fruit. It has the effects of calming the liver and relieving depression, promoting blood circulation and dispelling wind, improving eyesight, and relieving itching. It is used for headaches and dizziness, chest and rib pain, mastitis, red eyes with corneal opacity, and itchy rashes.

[0028] Bupleurum is the dried root of Bupleurum chinense DC. or Bupleurum corzonerifolium Willd., both belonging to the Apiaceae family. It has the functions of harmonizing the exterior and interior, soothing the liver, and raising yang. It is used for colds with fever, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0029] Actinolite is a silicate mineral formed by the replacement of more than 2% magnesium ions with ferrous ions in tremolite. It is also a member of the amphibole series, and these minerals are often referred to as amphibole asbestos. It has the effect of warming the kidneys and strengthening yang. It is used for kidney yang deficiency, impotence, seminal emission, premature ejaculation, soreness and weakness of the lower back and knees, infertility due to cold uterus, leukorrhea, abdominal masses, and metrorrhagia.

[0030] Morinda officinalis is the dried root of Morinda officinalis How, a plant in the Rubiaceae family. It has the effects of tonifying kidney yang, strengthening tendons and bones, and dispelling wind and dampness. It is used for impotence, seminal emission, infertility due to cold uterus, irregular menstruation, lower abdominal pain due to cold, rheumatic pain, and weakness of tendons and bones.

[0031] The present invention also proposes the application of the traditional Chinese medicine composition in the preparation of a drug for improving erectile dysfunction, comprising the following steps: first, mixing all components according to a predetermined weight ratio, adding water and decocting at least twice, combining all decoctions, filtering and concentrating to obtain a concentrated solution; then, preparing the concentrated solution into a drug for improving erectile dysfunction according to a predetermined preparation process.

[0032] As a preferred method, add 7-10 times the amount of water each time you decoct the food, and decoct at 100°C for 1-2 hours.

[0033] Preferably, during concentration, the filtrate is concentrated to a concentration with a relative density of 1.2 at 62°C and -0.05 MPa.

[0034] The beneficial effects of this invention are as follows: In the traditional Chinese medicine composition of this invention, Rhodiola rosea is the principal ingredient, which aims to invigorate qi and blood circulation and unblock the meridians; Astragalus membranaceus (processed) and Codonopsis pilosula (stir-fried) are used to invigorate qi and blood circulation, Angelica sinensis and Salvia miltiorrhiza are used to nourish blood and invigorate blood circulation, and Cistanche deserticola is used to invigorate the kidneys and strengthen yang, and to replenish essence and blood, serving as assistant ingredients to assist the principal ingredient in invigorating qi and blood circulation and replenishing essence and blood; Paeonia lactiflora, Lycium barbarum, Epimedium brevicornu, Eucommia ulmoides, Eupolyphaga sinensis, Eupolyphaga sinensis and Campsis grandiflora are added as adjuvant ingredients to synergistically exert the effects of regulating the liver and kidneys, strengthening tendons and bones, and invigorating blood circulation and unblocking the meridians; Achyranthes bidentata is added to guide the other ingredients downwards to the affected area; The principal, assistant, adjuvant and adjuvant ingredients of the whole formula are clearly distinguished, and the combination of the ingredients works synergistically to achieve the effects of invigorating qi and blood circulation, regulating the liver and kidneys; By regulating the male endocrine balance and repairing the smooth muscle and nerve damage of the corpus cavernosum, it can significantly improve penile erectile function, and the total effective rate for erectile dysfunction can reach more than 70%.

[0035] This invention also includes centipede, leech, tribulus terrestris, bupleurum, yangqi stone, and morinda officinalis. After adding these components, the overall effective rate for erectile dysfunction can reach over 75%. Among them, leech, centipede, yangqi stone, morinda officinalis, and cistanche deserticola are added as adjuvant herbs, while bupleurum and tribulus terrestris are added as assistant herbs. Leech and centipede, being insect-based medicines, are considered to have blood and flesh, which can further enhance the blood-activating, stasis-removing, wind-extinguishing, and meridian-clearing effects of the formula, opening the meridians and promoting the smooth flow of qi and blood in the genital area. Yangqi stone... Morinda officinalis and Cistanche deserticola can further enhance the effects of invigorating qi and warming the kidneys, and replenishing kidney essence. They help to supplement kidney essence on the basis of invigorating qi and promoting blood circulation, so that qi and blood have a source, and strengthen the generation of yang qi with warming and unblocking power. Bupleurum chinense and Tribulus terrestris can soothe the liver, relieve depression and promote blood circulation, so that liver qi is regulated and emotions are controlled. They also act as guiding drugs to allow the drugs to reach the disease site directly and flow down to the tendons, so that qi and blood can flow through and the tendons can be nourished. The liver and kidneys are of the same origin, and the mother's disease affects the child. So, products that soothe the liver and regulate blood can prevent disease before it occurs.

[0036] Based on the original formula of Hongjing No. 1, this invention aims to improve the treatment system of "invigorating qi and blood, tonifying the kidney and unblocking the collaterals" by adding Eucommia ulmoides, Cistanche deserticola, Eupolyphaga sinensis, Eupolyphaga sinensis and Campsis grandiflora. This improved scheme, while continuing the qi-invigorating and blood-activating effects of the original formula, enhances the regulatory effect of the formula on the microcirculation environment inside the corpus cavernosum (Zongjin) of the penis by introducing the methods of tonifying the kidney and replenishing essence and clearing away blood stasis. It also provides targeted repair for the damaged corpus cavernosum tissue structure and biomechanical properties. This effectively improves the clinical applicability of the formula for patients with organic erectile dysfunction or those with kidney essence deficiency and a tendency for prolonged illness to affect the collaterals. From a pathophysiological perspective, it further enriches the intervention methods for erectile dysfunction and its related pathological links.

[0037] The features and advantages of the present invention will be described in detail through embodiments and in conjunction with the accompanying drawings. Attached Figure Description

[0038] Figure 1 The experimental results of mICP / MAP and tICP / MAP in each group of rats are shown in the figure. Figure 2 Images showing Masson staining results of rat corpus cavernosum tissue from each group; Figure 3 Figure 1 shows the results of gene expression levels related to fibrosis in the corpus cavernosum tissue of rats in each group. Figure 4 Figure 1 shows the results of detecting the expression levels of proteins related to fibrosis in the corpus cavernosum tissue of rats in each group. In the attached figures, KB represents the blank group, M and Medel represent the model group, HL represents the low-dose traditional Chinese medicine gavage group, HM represents the medium-dose traditional Chinese medicine gavage group, and HH represents the high-dose traditional Chinese medicine gavage group. Detailed Implementation

[0039] Example 1 The traditional Chinese medicine composition, by weight, includes 15 parts of Rhodiola rosea, 20 parts of Astragalus membranaceus (processed), 15 parts of Codonopsis pilosula, 12 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, 15 parts of Paeonia lactiflora, 15 parts of Lycium barbarum, 10 parts of Epimedium brevicornu, 12 parts of Achyranthes bidentata, 10 parts of Eupolyphaga sinensis, 9 parts of Eupolyphaga sinensis, 15 parts of Campsis grandiflora, 15 parts of Eucommia ulmoides, and 15 parts of Cistanche deserticola.

[0040] Example 2 The traditional Chinese medicine composition, by weight, includes 9 parts of Rhodiola rosea, 10 parts of Astragalus membranaceus (processed), 10 parts of Codonopsis pilosula, 9 parts of Angelica sinensis, 10 parts of Salvia miltiorrhiza, 10 parts of Paeonia lactiflora, 10 parts of Lycium barbarum, 9 parts of Epimedium brevicornu, 10 parts of Achyranthes bidentata, 3 parts of Eupolyphaga sinensis, 3 parts of Eupolyphaga sinensis, 10 parts of Campsis grandiflora, 10 parts of Eucommia ulmoides, and 10 parts of Cistanche deserticola.

[0041] Example 3 The traditional Chinese medicine composition, by weight, includes 30 parts of Rhodiola rosea, 40 parts of Astragalus membranaceus (processed), 30 parts of Codonopsis pilosula, 20 parts of Angelica sinensis, 20 parts of Salvia miltiorrhiza, 30 parts of Paeonia lactiflora, 30 parts of Lycium barbarum, 30 parts of Epimedium brevicornu, 20 parts of Achyranthes bidentata, 12 parts of Eupolyphaga sinensis, 10 parts of Eupolyphaga sinensis, 20 parts of Campsis grandiflora, 20 parts of Eucommia ulmoides, and 20 parts of Cistanche deserticola.

[0042] Example 4 The traditional Chinese medicine composition, by weight, includes 15 parts of Rhodiola rosea, 20 parts of Astragalus membranaceus (processed), 15 parts of Codonopsis pilosula, 12 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, 15 parts of Paeonia lactiflora, 15 parts of Lycium barbarum, 10 parts of Epimedium brevicornu, 12 parts of Achyranthes bidentata, 10 parts of Eupolyphaga sinensis, 9 parts of Eupolyphaga sinensis, 15 parts of Campsis grandiflora, 15 parts of Eucommia ulmoides, 15 parts of Cistanche deserticola, 5 parts of Scolopendra subspinipes, 10 parts of Hirudo medicinalis, 20 parts of Tribulus terrestris, 12 parts of Bupleurum chinense, 12 parts of Yangqishi (a type of mineral), and 15 parts of Morinda officinalis.

[0043] Example 5 The traditional Chinese medicine composition, by weight, includes 15 parts of Rhodiola rosea, 20 parts of Astragalus membranaceus (processed), 15 parts of Codonopsis pilosula, 12 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, 15 parts of Paeonia lactiflora, 15 parts of Lycium barbarum, 10 parts of Epimedium brevicornu, 12 parts of Achyranthes bidentata, 10 parts of Eupolyphaga sinensis, 9 parts of Eupolyphaga sinensis, 15 parts of Campsis grandiflora, 15 parts of Eucommia ulmoides, 15 parts of Cistanche deserticola, 3 parts of Scolopendra subspinipes, 3 parts of Hirudo medicinalis, 10 parts of Tribulus terrestris, 9 parts of Bupleurum chinense, 10 parts of Yangqishi (a type of mineral), and 9 parts of Morinda officinalis.

[0044] Example 6 The traditional Chinese medicine composition, by weight, includes 15 parts of Rhodiola rosea, 20 parts of Astragalus membranaceus (processed), 15 parts of Codonopsis pilosula, 12 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, 15 parts of Paeonia lactiflora, 15 parts of Lycium barbarum, 10 parts of Epimedium brevicornu, 12 parts of Achyranthes bidentata, 10 parts of Eupolyphaga sinensis, 9 parts of Eupolyphaga sinensis, 15 parts of Campsis grandiflora, 15 parts of Eucommia ulmoides, 15 parts of Cistanche deserticola, 10 parts of Scolopendra subspinipes, 12 parts of Hirudo medicinalis, 30 parts of Tribulus terrestris, 20 parts of Bupleurum chinense, 20 parts of Yangqishi (a type of mineral), and 20 parts of Morinda officinalis.

[0045] Comparative Example Hongjing No. 1 Formula, by weight, includes 15 parts of Rhodiola rosea, 20 parts of Astragalus membranaceus (processed), 15 parts of Codonopsis pilosula, 12 parts of Angelica sinensis, 15 parts of Salvia miltiorrhiza, 15 parts of Paeonia lactiflora, 15 parts of Lycium barbarum, 10 parts of Epimedium brevicornu, and 12 parts of Achyranthes bidentata.

[0046] Preparation method: Weigh out the Chinese herbal composition according to the formula, decoct it into a concentrated liquid, and then make it into Chinese herbal tablets, granules, capsules or oral liquid preparations for improving erectile dysfunction according to the existing corresponding preparation process.

[0047] The method for preparing the concentrated solution from the various Chinese herbal medicine compositions is as follows: Add all components to an extraction tank according to the predetermined weight proportions, add 8 times the amount of water, heat, and start timing when the temperature inside the tank reaches 100℃, decocting for 1.5 hours; after decoction, lower the temperature inside the tank to 70℃, filter the decoction to obtain filtrate I; add another 8 times the amount of water, continue decocting for 1.5 hours, and obtain filtrate II using the same method as filtrate I; combine filtrate I and filtrate II; centrifuge at room temperature at 3000 rpm for 20 minutes; input the centrifuged liquid into a concentrator, control the temperature of the concentrator at 65℃, and concentrate to a relative density of 1.2 under a vacuum of -0.05 MPa or higher to obtain the concentrated solution.

[0048] The tablet preparation method may include: ① Place the obtained concentrate into a clarifying tank, heat to 50℃, slowly add 10 parts of chitosan clarifying agent (prepared with 2% acetic acid solution to form 1% chitosan colloidal solution) while stirring. After the clarifying agent is added, continue to keep warm and stir for 30 minutes. After cooling to room temperature, let stand overnight, centrifuge at 3000 rpm for 20 minutes; transfer the centrifuged liquid into a concentrator, control the temperature of the concentrator at 65℃, and concentrate it to a thick paste with a relative density of 1.44 under a vacuum of -0.05 MPa or higher. ② Spray drying: When the inlet air temperature rises to 160℃, pre-spraying with purified water begins. When the inlet and outlet air temperatures reach the set values ​​and the temperature fluctuation range does not exceed ±5℃, feeding begins. Five minutes after the spraying begins, the No. 1 powder collection bucket should be replaced, and powder should be collected every 10-20 minutes thereafter. Transfer the extract powder to a pre-prepared clean container, let it cool, and then pass it through a No. 7 sieve. Collect the extract powder obtained through the No. 7 sieve and seal it. ③ Add appropriate amounts of powdered sugar and dextrin to the extract powder, mix well, form into granules, dry, and press into tablets (coated).

[0049] The preparation method of granules can be as follows: the obtained concentrate is directly granulated by dry method without the addition of excipients, and the granules with a water content of ≤0.5% are obtained by sieving and then packaged.

[0050] Methods for preparing capsules may include: ① Place the obtained concentrate into a clarifying tank, heat to 40℃, slowly add 10 parts of chitosan clarifying agent (prepared with 2% acetic acid solution to form 1% chitosan colloidal solution) while stirring. After the clarifying agent is added, continue to keep warm and stir for 30 minutes. After cooling to room temperature, let stand overnight, centrifuge at 3000 rpm for 20 minutes; transfer the centrifuged liquid into a concentrator, control the temperature of the concentrator at 65℃, and concentrate it to a thick paste with a relative density of 1.32 under a vacuum of -0.05 MPa or higher. ② Spray drying: When the inlet air temperature rises to 160℃, pre-spraying with purified water begins. When the inlet and outlet air temperatures reach the set values ​​and the temperature fluctuation range does not exceed ±5℃, feeding begins. The powder collection bucket should be replaced 5 minutes after the spraying begins, and powder should be collected every 10-20 minutes thereafter. The extract powder is transferred to a pre-prepared clean container, cooled, and then passed through a No. 7 sieve. The extract powder obtained through the No. 7 sieve is collected and sealed. ③ Add an appropriate amount of starch to the extract powder, mix well, dry at low temperature, pulverize into fine powder, sieve, mix well, and fill into capsules to obtain the final product.

[0051] Methods for preparing oral liquid formulations may include: ① Place the obtained concentrate into a clarifying tank, heat to 45℃, slowly add 10 parts of chitosan clarifying agent (prepared with 2% acetic acid solution to form 1% chitosan colloidal solution) while stirring. After the clarifying agent is added, continue to keep warm and stir for 30 minutes. After cooling to room temperature, let stand overnight, centrifuge to collect the filtrate. Centrifuge at 3000 rpm for 20 minutes. Concentrate the filtrate to about 2 parts of crude drug per milliliter and refrigerate. ② Filter the concentrated filtrate obtained in step ①, add water to 2000 parts, add an appropriate amount of sugar-free sweetener and preservative, filter, stir evenly, fill, sterilize, and the oral liquid is obtained.

[0052] Of course, the herbal combination can also be decocted directly to make a soup for consumption.

[0053] Basic experimental research Take 100g of the traditional Chinese medicine granules prepared using the traditional Chinese medicine composition of Example 1 for improving erectile dysfunction, add 300mL of hot water at 80-100℃ and stir for 2min. After the product is completely dissolved (slight turbidity is permissible, but there are no foreign objects such as burnt debris), administer the drug to rats with bilateral cavernous nerve injury-induced erectile dysfunction (NED) by gavage. Administer the drug once a day for four consecutive weeks and observe the effect of the drug on the erectile function of the NED rats.

[0054] The results are as follows: Table 1

[0055] The results showed that, compared with normal rats, NED rats exhibited significantly reduced mating behavior; and apomorphine (APO) significantly reduced the success rate of induced erection in NED rats. After 4 weeks of gavage treatment, mating behavior in NED rats significantly increased, and the success rate of induced erection in NED rats treated with apomorphine (APO) showed an increasing trend compared with the model group.

[0056] Animal model control experiments were conducted, and the results of mICP / MAP and tICP / MAP were as follows: Figure 1 As shown: Compared with normal rats, the ratios of maximum intracavernosal pressure / mean arterial pressure (mICP / MAP) and tICP / MAP in NED rats were significantly decreased. After 4 weeks of gavage treatment with low-dose, medium-dose, and high-dose traditional Chinese medicine, the ratios of mICP / MAP and tICP / MAP in NED rats were significantly increased, indicating that erectile function in NED rats was significantly improved.

[0057] like Figure 2As shown, Masson staining results indicated that smooth muscle fibers in the normal group rats were red and collagen fibers were blue. Compared with normal rats, the collagen ratio of the corpus cavernosum smooth muscle in NED rats was significantly reduced. After 4 weeks of treatment with low-dose, medium-dose, and high-dose traditional Chinese medicine via gavage, the collagen in the corpus cavernosum smooth muscle of NED rats was significantly improved.

[0058] Simultaneously, this study also examined the changes in the expression of α-smooth muscle actin (SMA), fibronectin (FN), type I collagen (COLI), type III collagen (COLIII), and transforming growth factor (TGF)-β1 in the corpus cavernosum tissue of rats in each group. The experimental results are as follows: Figure 3 As shown.

[0059] PCR results showed that, compared with normal rats, the gene expression level of α-SMA in NED rats was relatively decreased, while the gene expression levels of FN, COLI, COLIII, and TGF-β1 were relatively increased, with statistically significant differences (P<0.01). After 4 weeks of gavage treatment with low-dose, medium-dose, and high-dose traditional Chinese medicine, the gene expression level of α-SMA increased, while the gene expression levels of FN, COLI, COLIII, and TGF-β1 decreased significantly.

[0060] like Figure 4 As shown in the Western blot results, compared with normal rats, NED rats had a relatively lower protein expression level of α-SMA and a relatively higher protein expression level of FN, COLI, COLIII, and TGF-β1, with statistically significant differences (P<0.01). After 4 weeks of gavage treatment with low-dose, medium-dose, and high-dose traditional Chinese medicine, the relative protein expression level of α-SMA increased, while the relative protein expression levels of FN, COLI, COLIII, and TGF-β1 decreased significantly.

[0061] As can be seen from the above animal experiments, the oral Chinese medicine preparation for improving erectile dysfunction prepared from the Chinese medicine composition in Example 1 is very effective in improving the erectile function of NED rats and ED rats caused by hypoxia.

[0062] We will continue to select the traditional Chinese medicine compositions from Examples 1 and 4 to prepare oral traditional Chinese medicine preparations (granules) for improving erectile dysfunction, and conduct clinical trials.

[0063] First, 159 patients with erectile dysfunction who met the inclusion criteria but did not meet the exclusion criteria were selected and randomly divided into three groups: Jingtian Yishen Granules Treatment Group 1 (Example 1), Jingtian Yishen Granules Treatment Group 2 (Example 4), and Hongjing No. 1 Granules (Comparative Example) Control Group, with 53 patients in each group.

[0064] The criteria for evaluating the efficacy are: 1. Key efficacy indicator: International Indicator of Erectile Function (IIEF-5) efficacy evaluation criteria: (1) Cured: IIEF-5 score ≥ 22 after treatment; (2) Significantly effective: IIEF-5 score < 22 after treatment, with an improvement of ≥ 60%; (3) Effective: IIEF-5 score < 22 after treatment, with an improvement of < 60%, but ≥ 30%; (4) Ineffective: IIEF-5 score < 22 after treatment, with an improvement of < 30%.

[0065] 2. Evaluation criteria for secondary therapeutic efficacy indicators based on TCM syndrome scoring: (1) Clinically cured in the near term: TCM clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥90%; (2) Significantly effective: TCM clinical symptoms and signs are significantly improved, and the syndrome score decreases by ≥60%; (3) Effective: TCM clinical symptoms and signs are improved, and the syndrome score decreases by <60% or ≥30%; (4) Ineffective: TCM clinical symptoms and signs do not improve or even worsen, and the syndrome score decreases by <30%.

[0066] The integral change formula (nimodipine method) is: [(integral before treatment - integral after treatment) ÷ integral before treatment] × 100%.

[0067] The IIEF-5 score and TCM syndrome score of the patients were recorded before the start of treatment and 4 weeks after the start of treatment, and the scores were systematically analyzed.

[0068] Results: Three cases dropped out in both the Jingtian Yishen Granules treatment group and the Hongjing No. 1 Formula control group, resulting in a final effective case count of 150 cases; the analysis results are shown in the table below.

[0069] Table 2

[0070] As shown in Table 2, before treatment, there was no significant difference in IIEF-5 scores between treatment groups 1 and 2 and the control group (P>0.05), indicating comparability. After treatment, all three groups showed significant differences compared to before treatment (P<0.01), indicating that all three groups had a good effect on improving erectile dysfunction from the perspective of IIEF-5 score assessment. At the same time, after treatment, treatment groups 1 and 2 also showed significant differences compared to the control group (P<0.05), indicating that the therapeutic effect of Jingtian Yishen Granules was better than that of Hongjing No. 1 Formula, and the therapeutic effect of treatment group 2 was better than that of treatment group 1.

[0071] Table 3

[0072] As shown in Table 3, before treatment, there were no significant differences in the TCM symptom scores between treatment groups 1 and 2 and the control group (P>0.05), indicating comparability. After treatment, all three groups showed significant differences compared to before treatment (P<0.01), indicating that from the perspective of TCM symptom score evaluation, all three groups had a good effect on improving erectile dysfunction. At the same time, after treatment, treatment group 1 also showed a significant difference compared to the control group (p<0.05), indicating that the therapeutic effect of Jingtian Yishen Granules was better than that of Hongjing No. 1 Formula, and the therapeutic effect of treatment group 2 was better than that of treatment group 1.

[0073] Table 4

[0074] Table 4 shows that there is a significant difference in the total effective rate of treating erectile dysfunction between the treatment group and the control group. The total effective rate of the treatment group is significantly better than that of the control group (P<0.01). At the same time, the total effective rate of treatment group 2 is significantly better than that of treatment group 1 (P<0.05). This table indicates that the total effective rate of Jingtian Yishen Granules is significantly better than that of Hongjing No. 1 Granules, and the total effective rate of treatment group 2 is better than that of treatment group 1.

[0075] Clinical trials: The diagnostic criteria for erectile dysfunction are as follows: 1. Western medical diagnostic criteria for erectile dysfunction: (1) The penis cannot achieve or maintain a sufficient erection to complete satisfactory sexual intercourse, and the course of the disease is more than 3 months; (2) Severity grading criteria: The severity of ED is judged according to the International Erectile Function Questionnaire-5 (IIEF-5); IIEF-5 ≤ 21 points indicates that the patient has ED; the severity is divided into mild 12-21 points, moderate 8-11 points, and severe 5-7 points.

[0076] 2. Traditional Chinese Medicine diagnostic criteria for erectile dysfunction due to Qi deficiency and blood stasis: The criteria are formulated based on the relevant syndromes in the "Guiding Principles for Clinical Research on New Traditional Chinese Medicine Drugs for the Treatment of Erectile Dysfunction". The main symptoms are: inability to achieve or maintain an erection sufficient for satisfactory erection, resulting in flaccidity, weak erection, or short-lived erection, accompanied by aversion to cold and cold limbs. The secondary symptoms are: stabbing pain in the chest and ribs, lower abdominal distension, perineal distension, scrotal pain, soreness and weakness in the lower back and knees, and aversion to cold and cold limbs. The tongue and pulse are: dark purple tongue with petechiae or ecchymosis, white coating, and deep and hesitant or thready and hesitant pulse. The main symptoms are essential, and the presence of 3 secondary symptoms and the appearance of the tongue and pulse are sufficient for diagnosis.

[0077] The inclusion criteria for patients with erectile dysfunction are: (1) Those who meet the Western medical diagnostic criteria for erectile dysfunction (ED); (2) Those who meet the TCM diagnostic criteria for erectile dysfunction-Qi deficiency and blood stasis type; (3) Males aged 20≤age≤60 years, with the conditions for cohabitation and normal libido; (4) IIEF-5≤21 points; (5) Disease duration≥12 weeks; (6) Those who have voluntarily signed the informed consent form.

[0078] The specific treatment plan is as follows: Patients in the Jingtian Yishen Granules treatment group 1 take Jingtian Yishen Granules prepared using the traditional Chinese medicine composition of Example 1 of this invention, and patients in the Jingtian Yishen Granules treatment group 2 take Jingtian Yishen Granules prepared using the traditional Chinese medicine composition of Example 4 of this invention. The decoction-free granules are uniformly prepared and provided by Zhejiang Huisong Pharmaceutical Co., Ltd. using granules of the same batch number and packaged in moisture-proof decoction-free bags. The method of administration is as follows: take it with 200 mL of warm water each time, twice a day, 40 minutes before breakfast and dinner, for a course of treatment of 4 weeks.

[0079] The control group, which received Hongjing No. 1 formula, took Hongjing No. 1 granules (Inner Mongolia Lantai Pharmaceutical Co., Ltd., National Drug Approval Number Z20030099, specification 2 g×10 sachets, purchased uniformly by the Pharmacy Department of Zhejiang Provincial Hospital of Integrated Traditional and Western Medicine). The method of administration was: take it with 200 mL of warm water each time, twice a day, 40 minutes before breakfast and dinner, for a course of treatment of 4 weeks.

[0080] During treatment, all patients must not take any other medications that are effective in treating this disease.

[0081] Standards for Evaluating the Efficacy of Traditional Chinese Medicine Kidney Tonification Therapy (Clinical Symptom Scoring)

[0082] Summary table of clinical efficacy comparison

[0083] Typical clinical cases Case 1 Mr. Zhang, male, 45 years old; The patient reported that two years ago, due to work fatigue and high mental stress, he began to experience decreased libido and decreased erectile rigidity, with occasional mid-intercourse flaccidity; In the past three months, the symptoms have worsened significantly, manifested as penile erection that is not firm, so he went to the hospital for treatment. Sex hormone tests were normal, IIEF-5 score was 12, and AVSS and NPTR tests indicated no effective erection.

[0084] Clinical examination: The patient appears listless, has a pale and dull complexion, low libido, perineal pain and discomfort, normal appetite and bowel movements, frequent awakenings and vivid dreams during sleep, no other discomfort, a dark tongue with obvious teeth marks on the sides, varicose veins under the tongue, and a deep, thready, and hesitant pulse.

[0085] Western medical term: Erectile dysfunction Traditional Chinese Medicine term for impotence: Traditional Chinese Medicine Syndrome: Qi Deficiency and Blood Stasis Treatment: Tonify Qi and invigorate blood circulation, unblock the meridians and relieve weakness. Prescription: Rhodiola rosea 20 g, Astragalus membranaceus (processed) 20 g, Codonopsis pilosula 15 g, Angelica sinensis 12 g, Salvia miltiorrhiza 15 g, Paeonia lactiflora 15 g, Lycium barbarum 15 g, Epimedium brevicornu 15 g, Achyranthes bidentata 12 g, Eupolyphaga sinensis 10 g, Eupolyphaga sinensis 9 g, and Campsis grandiflora 15 g; 14 doses.

[0086] Preparation and administration: Decoction of the above ingredients in water, one dose per day; first soak for half an hour, then bring to a boil over high heat, then simmer over low heat for 10 minutes; pour out the liquid, decoct again, and use the same method as above; mix the two decoctions and take in two doses; the interval between the two doses should be more than 4 hours.

[0087] Follow-up visit 15 days later: The patient felt that his mental state had improved, his fatigue had lessened, and the frequency of morning erections had increased compared to before, but the improvement in erectile hardness was not obvious, and he still had obvious soreness and coldness in his lower back and knees; his tongue was slightly redder than before, and the teeth marks were still there; Eucommia ulmoides and Cistanche deserticola were added to the previous prescription, and he continued to take the same prescription for 14 days to observe the efficacy.

[0088] Fifteen days later, at the third consultation: After taking the above prescription for another 14 doses, all the aforementioned symptoms disappeared, and he was able to complete sexual intercourse.

[0089] Instruct the patient to avoid staying up late, not to engage in excessive sexual activity as function recovers, to jog about 2 kilometers daily, and to abstain from spicy foods, tobacco, and alcohol.

[0090] Case 2 Patient information: Li, male, 38 years old.

[0091] Chief complaint: Decreased erectile function accompanied by fatigue and weakness for more than one year.

[0092] Present Illness: The patient is a programmer at an internet company. For the past year, he has been working long hours and staying up late due to project launches, resulting in immense pressure. He reports a significant decrease in libido. Although he can achieve an erection, the hardness is extremely poor (EHS grade 2), and the duration of erection is short, often becoming flaccid before penetration. He previously took sildenafil, which was effective, but after the medication wore off, he experienced severe headaches and facial flushing, so he sought treatment from traditional Chinese medicine. His IIEF-5 score is 10.

[0093] Clinical examination: The patient appears tired, has little energy and is reluctant to speak. He occasionally experiences dizziness and blurred vision, and his lower back and knees feel weak. He sweats profusely after sexual intercourse. He also occasionally experiences a feeling of heaviness or distension in the perineum. His tongue is pale purple with numerous teeth marks on the sides. The veins under his tongue are bluish and tortuous. His pulse is deep, thready, and weak.

[0094] Western medical term: Erectile dysfunction Traditional Chinese Medicine term for impotence: Traditional Chinese Medicine Syndrome: Qi Deficiency and Blood Stasis Syndrome (accompanied by Kidney Essence Deficiency) Treatment: Tonify Qi and blood, strengthen the kidneys and invigorate Yang, and unblock the meridians to treat impotence.

[0095] Prescription: Rhodiola rosea 20g, Astragalus membranaceus (processed) 30g, Codonopsis pilosula 15g, Angelica sinensis 12g, Salvia miltiorrhiza 15g, Paeonia lactiflora 15g, Lycium barbarum 15g, Epimedium brevicornu 15g, Eucommia ulmoides 15g, Cistanche deserticola 15g, Achyranthes bidentata 12g, Eupolyphaga sinensis 10g, Eupolyphaga sinensis 9g, Campsis grandiflora 15g; 14 doses in total.

[0096] Preparation and administration: Same as before (decocted in water, one dose per day, the two doses of decoction mixed and taken separately).

[0097] Follow-up visit 14 days later: The patient reported significant improvement in mental state and reduced fatigue after working overtime; the frequency of morning erections increased from once a week to four times, and the hardness improved; the tongue turned pale red, the teeth marks decreased slightly, and the pulse was thready.

[0098] Treatment: Continue the prescribed medication for 14 doses to consolidate the foundation.

[0099] 28 days later, at the third visit: the erection hardness reached EHS grade 4, and sexual intercourse could be completed smoothly. The patient's self-satisfaction level was high; the IIEF-5 score was 21 points after retesting.

[0100] Doctor's advice: Quit smoking and drinking, maintain a regular sleep schedule, avoid prolonged sitting, and it is recommended to perform Kegel exercises daily to strengthen the pelvic floor muscles.

[0101] Case 3 Patient information: Zhao, male, 52 years old.

[0102] Chief complaint: Erectile dysfunction for 2 years, worsening in the past 6 months.

[0103] Present Illness: The patient has a 5-year history of hypertension and has been taking antihypertensive drugs for a long time; erectile dysfunction has occurred in the past 2 years, with penile penetration becoming increasingly difficult and almost no effective erection in the past 6 months; physical examination revealed that the patient is overweight, and sex hormone levels indicated that testosterone levels were at a borderline low value; NPTR test showed that the hardness and frequency of nocturnal erections were significantly lower than the normal values ​​for the same age; IIEF-5 score was 8.

[0104] Clinical examination: The patient has a dull complexion, lack of energy in the eyes, soreness and coldness in the lower back and knees, and aversion to cold; low libido, occasional stabbing pain in the lower abdomen and groin; dark red tongue with obvious petechiae, enlarged tongue body, engorged and purplish-black sublingual veins, and a deep and hesitant pulse.

[0105] Western medical term: Erectile dysfunction Traditional Chinese Medicine term for impotence: Traditional Chinese Medicine Syndrome: Qi Deficiency and Blood Stasis Syndrome (Kidney Yang Insufficiency, Blood stasis in the Collaterals) Treatment principle: Tonify Qi and warm the kidneys, and clear away blood stasis in the collaterals.

[0106] Prescription: Rhodiola rosea 25g, Astragalus membranaceus (processed) 40g (heavy dose), Codonopsis pilosula 15g, Angelica sinensis 15g, Salvia miltiorrhiza 20g, Paeonia lactiflora 15g, Lycium barbarum 15g, Epimedium brevicornu 20g (heavy dose), Eucommia ulmoides 20g, Cistanche deserticola 20g, Achyranthes bidentata 12g, Eupolyphaga sinensis 12g, Eupolyphaga sinensis 10g, Campsis grandiflora 20g; 14 doses in total.

[0107] Preparation and administration: Same as before.

[0108] Follow-up visit 14 days later: The patient's lower back and knee pain and coldness have lessened, and his aversion to cold has improved; although he has not had successful sexual intercourse, he reported feeling fullness in his penis in the morning, which is a sign that the medicine is gradually taking effect and his Yang energy is recovering; the petechiae on the sides of his tongue have decreased, and his pulse has become deep and thready.

[0109] Treatment: If the effect is not improved, continue to take the original prescription for 14 more doses.

[0110] 28 days later, at the third visit: the patient reported that penile rigidity had significantly improved, and he could successfully complete sexual intercourse, which lasted about 5-8 minutes; the perineal stinging sensation had disappeared, and his complexion had become more radiant; the IIEF-5 score was 18 points after a follow-up test.

[0111] Doctor's advice: Control blood pressure, follow a low-salt, low-fat diet, maintain a good mood, and persist in aerobic exercise.

[0112] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention can have various modifications and variations. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, By weight, it includes the following components: Rhodiola rosea 9-30 parts, Astragalus membranaceus (processed) 10-40 parts, Codonopsis pilosula 10-30 parts, Angelica sinensis 9-20 parts, Salvia miltiorrhiza 10-20 parts, Paeonia lactiflora 10-30 parts, Lycium barbarum 10-30 parts, Epimedium brevicornu 9-30 parts, Achyranthes bidentata 10-20 parts, Eupolyphaga sinensis 3-12 parts, Eupolyphaga sinensis 3-10 parts, Campsis grandiflora 10-20 parts, Eucommia ulmoides 10-20 parts, and Cistanche deserticola 10-20 parts.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, By weight, it includes the following components: 15 parts Rhodiola rosea, 20 parts Astragalus membranaceus (processed), 15 parts Codonopsis pilosula, 12 parts Angelica sinensis, 15 parts Salvia miltiorrhiza, 15 parts Paeonia lactiflora, 15 parts Lycium barbarum, 10 parts Epimedium brevicornu, 12 parts Achyranthes bidentata, 10 parts Eupolyphaga sinensis, 9 parts Eupolyphaga sinensis, 15 parts Campsis grandiflora, 15 parts Eucommia ulmoides, and 15 parts Cistanche deserticola.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it also includes the following components: 3-10 parts centipede, 3-12 parts leech, 10-30 parts tribulus, 9-20 parts bupleurum, 10-20 parts yangqi stone, and 9-20 parts morinda root.

4. The traditional Chinese medicine composition as described in claim 3, characterized in that, By weight, it also includes the following components: 5 parts centipede, 10 parts leech, 20 parts tribulus, 12 parts bupleurum, 12 parts yangqi stone, and 15 parts morinda root.

5. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for improving erectile dysfunction.

6. The application of the traditional Chinese medicine composition as described in claim 5 in the preparation of a drug for improving erectile dysfunction, characterized in that, The process includes the following steps: First, mix all components according to the preset weight proportions, add water and decoct at least twice, combine all the decoctions, filter and concentrate to obtain a concentrated solution; then, prepare the concentrated solution into an erectile dysfunction improvement drug according to the preset preparation process.

7. The application of the traditional Chinese medicine composition as described in claim 6 in the preparation of a drug for improving erectile dysfunction, characterized in that: Each time you decoct, add 7-10 times the amount of water and simmer at 100℃ for 1-2 hours.

8. The use of the traditional Chinese medicine composition as described in claim 6 in the preparation of a drug for improving erectile dysfunction, characterized in that: During concentration, the filtrate is concentrated to a relative density of 1.2 at 62℃ and -0.05 MPa.

9. A traditional Chinese medicine oral preparation for improving erectile dysfunction, characterized in that, It is prepared using the traditional Chinese medicine composition as described in any one of claims 1 to 4.

10. The oral Chinese medicine preparation as described in claim 9, characterized in that: The oral Chinese medicine preparations mentioned are decoctions, tablets, granules, capsules, or oral liquids.

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