Traditional Chinese medicine compound for invigorating kidney and strengthening yang and improving and promoting male sexual function and preparation method of traditional Chinese medicine compound

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound for invigorating kidney and strengthening yang and improving and enhancing male sexual function and a preparation method thereof. The traditional Chinese medicine compound is prepared from the following components in parts by mass: 5 to 30 parts of black radix aconiti lateralis preparata, 10 to 40 parts of herba epimedii, 10 to 30 parts of fructus psoraleae, 3 to 15 parts of cortex cinnamomi, 5 to 35 parts of herba cistanche, 10 to 50 parts of actinolitum brevicompactum, 10 to 35 parts of radix rehmanniae preparata, 5 to 25 parts of radix morindae officinalis, 5 to 30 parts of deer-horn glue, 5 to 35 parts of radix salviae miltiorrhizae, 5 to 35 parts of fructus corni, 5 to 35 parts of fructus lycii, 6 to 25 parts of rhizoma curculiginis, 5 to 35 parts of cortex moutan and 10 to 40 parts of radix astragali seu hedysari. Through scientific compatibility, all the components cooperate with one another and jointly act on the male sexual dysfunction caused by kidney-yang deficiency, the traditional Chinese medicine can warm yang and tonify the kidney, meanwhile, yin injury caused by excessive heat can be avoided, blood circulation is promoted to remove blood stasis, and overall qi and blood circulation is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine complex that can be used for tonifying the kidney and strengthening yang, improving and enhancing male sexual function, and a preparation method thereof. Background Art

[0002] Deficiency of kidney yang is a common pathological state in traditional Chinese medicine theory, mainly manifested as deficiency of kidney yang and decline of the fire of the gate of vitality, resulting in the loss of warmth of the body, presenting symptoms such as aversion to cold and cold limbs, soreness and weakness of the waist and knees, decreased sexual desire, impotence, premature ejaculation and other sexual dysfunctions. With the acceleration of the modern life rhythm, people are facing greater life and work pressures, and sexual dysfunctions caused by deficiency of kidney yang are becoming increasingly common among men, and the onset age tends to be younger.

[0003] In traditional Chinese medicine treatment, sexual dysfunctions caused by deficiency of kidney yang are often treated with traditional Chinese medicine prescriptions for warming and tonifying kidney yang and replenishing essence and marrow. For example, classic prescriptions such as Yougui Pills and Jinkui Shenqi Pills are widely used clinically to treat symptoms such as impotence and premature ejaculation caused by deficiency of kidney yang. In addition, modern research also shows that traditional Chinese medicine compound prescriptions can effectively improve the sexual function of patients with deficiency of kidney yang through mechanisms such as regulating endocrine, improving blood circulation, and enhancing nerve function. However, existing traditional Chinese medicine compound prescriptions are mostly based on traditional classic prescriptions and lack innovative formulations for modern lifestyle and disease spectrum changes. Therefore, developing an efficient traditional Chinese medicine composition for male sexual dysfunctions of the deficiency of kidney yang type and optimizing the composition and ratio of the traditional Chinese medicine composition is of great significance for enriching treatment plans and optimizing treatment ideas. Summary of the Invention

[0004] The purpose of the present invention is to provide an efficient traditional Chinese medicine composition for male sexual dysfunctions of the damp-heat pouring downward type, providing a new choice for clinical treatment.

[0005] The present invention provides a traditional Chinese medicine composition for male sexual dysfunctions caused by deficiency of kidney yang. Calculated by mass parts, the traditional Chinese medicine complex comprises the following components: 5 - 30 parts of black aconite, 10 - 40 parts of epimedium, 10 - 30 parts of psoralea corylifolia, 3 - 15 parts of cinnamon, 5 - 35 parts of cistanche deserticola, 10 - 50 parts of actinolite, 10 - 35 parts of rehmannia glutinosa, 5 - 25 parts of morinda officinalis, 5 - 30 parts of deer horn glue, 5 - 35 parts of salvia miltiorrhiza, 5 - 35 parts of cornelian cherry fruit, 5 - 35 parts of wolfberry fruit, 6 - 25 parts of curculigo orchioides, 5 - 35 parts of moutan bark, 10 - 40 parts of astragalus membranaceus.

[0006] Preferably, calculated by mass parts, the traditional Chinese medicine complex comprises the following components: 6 parts of gentian, 3 parts of coptis, 10 parts of honeysuckle, 10 parts of alisma orientale, 20 parts of dianthus superbus, 30 parts of coix seed, 12 parts of anemarrhena asphodeloides, 10 parts of raw rehmannia root.

[0007] The present invention also provides a traditional Chinese medicine complex prepared from the traditional Chinese medicine composition according to the above technical solution. The preparation method of the traditional Chinese medicine complex comprises the following steps: After Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Herba Cistanches, Pyritum, Radix Rehmanniae Praeparata, Fructus Corni, Fructus Lycii, Rhizoma Curculiginis and Cortex Moutan are pulverized, a first pulverized product is obtained. The first pulverized product is mixed with laccase and cellulase for primary enzymatic hydrolysis. After the primary enzymatic hydrolysis is completed, water is used as a solvent for primary ultrasonic extraction to obtain an aqueous extract. After Epimedii Folium, Fructus Psoraleae, Radix Morindae Officinalis, Colla Cornus Cervi, Radix Salviae Miltiorrhizae and Radix Astragali are pulverized, a second pulverized product is obtained. The second pulverized product is mixed with laccase and cellulase for primary enzymatic hydrolysis. After the primary enzymatic hydrolysis is completed, a 75% ethanol solution is used as a solvent for secondary ultrasonic extraction to obtain an ethanol extract. The aqueous extract and the ethanol extract are combined to obtain the traditional Chinese medicine complex.

[0008] Preferably, the mass ratio of laccase to cellulase is 1:1-2.

[0009] Preferably, the mass ratio of the total mass of laccase and cellulase to the first pulverized product is 1-5:100-200, and the mass ratio of the total mass of laccase and cellulase to the second pulverized product is 1-5:100-200.

[0010] Preferably, the temperature of the primary enzymatic hydrolysis is 50°C-60°C, and the time of the primary enzymatic hydrolysis is 40-50 h.

[0011] Preferably, the solid-liquid ratio of the primary ultrasonic extraction is 1:1-10, and the solid-liquid ratio of the secondary ultrasonic extraction is 1:1-10.

[0012] Preferably, the temperature of the primary ultrasonic extraction is 50°C-60°C, and the time is 40-60 min; the temperature of the secondary ultrasonic extraction is 50°C-70°C, and the time is 30-50 min.

[0013] The present invention also provides a product for male sexual dysfunction caused by kidney-yang deficiency. The product comprises the traditional Chinese medicine complex according to the above technical solution.

[0014] Preferably, the dosage form of the product includes decoction, paste, pill and powder Advantages of the present invention: The complex provided by the present invention mainly targets the pathogenesis of kidney-yang deficiency, manifested as fear of cold and cold limbs, soreness and weakness of the waist and knees, impotence and spermatorrhea, frequent urination, pale complexion, listlessness, etc. At the same time, drugs for nourishing yin and promoting blood circulation are added to the formula to avoid excessive heat damaging yin while warming yang and tonifying the kidney, taking into account promoting blood circulation and removing blood stasis to improve the overall qi and blood circulation.

[0015] This composition, through the synergistic effect of various traditional Chinese medicines for warming and tonifying the kidney yang (such as Epimedium, Psoralea corylifolia, Morinda officinalis, deer horn glue, etc.), can effectively improve symptoms such as impotence, premature ejaculation, and decreased libido caused by kidney yang deficiency. For example, icariin in Epimedium can promote the secretion of male hormones, enhance the hardness and duration of penile erection. Ingredients such as Cistanche deserticola and Morinda officinalis can improve the blood circulation of the corpus cavernosum of the penis, improve sperm quality and motility, and have a significant effect on sexual dysfunction and infertility caused by kidney deficiency. In addition, Lycium barbarum can assist in improving sexual dysfunction by nourishing the liver and kidney and improving eyesight with essence. Ingredients such as Rehmannia glutinosa, Cornus officinalis, and Astragalus membranaceus in the formula can not only warm and tonify the kidney yang, but also regulate the qi and blood of the whole body, and relieve symptoms such as soreness and weakness of the waist and knees, fear of cold and cold limbs, and fatigue caused by kidney yang deficiency.

[0016] This composition comprehensively improves the physique of patients with kidney yang deficiency through multi-target action mechanisms such as warming and tonifying the kidney yang, replenishing essence and marrow, and promoting blood circulation to remove blood stasis. For example, the addition of Salvia miltiorrhiza and Paeonia suffruticosa can promote blood circulation to remove blood stasis, improve blood circulation, and further enhance sexual function.

[0017] This composition uses natural traditional Chinese medicine ingredients, and through reasonable compatibility, it avoids the excessive use of single drugs and reduces potential side effects. At the same time, its mild warming and tonifying effect is suitable for long-term conditioning and can fundamentally improve the physique of kidney yang deficiency. Detailed implementation methods

[0018] To further illustrate the present invention, the following examples are used to describe in detail a traditional Chinese medicine complex that can be used for tonifying the kidney and strengthening yang, improving and enhancing male sexual function and its preparation method provided by the present invention, but they cannot be understood as limiting the protection scope of the present invention.

[0019] The information of the traditional Chinese medicines used in the present invention is as follows: Aconiti Lateralis Radix Praeparata: The processed lateral root of Aconitum carmichaelii Debx. of the Ranunculaceae family, pungent, sweet, and extremely hot; toxic. It belongs to the heart, kidney, and spleen meridians, restoring yang to rescue from collapse, tonifying fire to assist yang, and expelling wind-cold-damp pathogens. It is used for yang collapse and profuse sweating, impotence, cold uterus, cold pain in the heart and abdomen, deficiency-cold vomiting and diarrhea, yin-cold edema, etc. Aconitum carmichaelii Epimedium: The aerial parts of Epimedium brevicornu Maxim. of the Berberidaceae family, pungent, sweet, and warm. It belongs to the liver and kidney meridians, tonifying the kidney yang, strengthening the muscles and bones, and dispelling wind-dampness. It is used for kidney yang deficiency, impotence and spermatorrhea, flaccidity of muscles and bones, wind-dampness arthralgia, numbness and contracture, etc.

[0020] Psoralea corylifolia: The dried ripe fruits of Psoralea corylifolia Linn. of the Fabaceae family, pungent, bitter, and warm. It belongs to the kidney and spleen meridians, warming the kidney to assist yang, reducing qi to relieve asthma, and warming the spleen to stop diarrhea. Externally, it dispels wind and removes freckles. Epimedium brevicornu Cinnamomum cassia: The bark of Cinnamomum cassia Presl of the Rutaceae family

[0021] Cinnamomum cassia: The bark of Cinnamomum cassia Presl of the Rutaceae family Psoralea corylifolia Psoralea corylifolia: The dried ripe fruits of Psoralea corylifolia Linn. of the Fabaceae family, pungent, bitter, and warm. It belongs to the kidney and spleen meridians, warming the kidney to assist yang, reducing qi to relieve asthma, and warming the spleen to stop diarrhea. Externally, it dispels wind and removes freckles.

[0022] Cinnamomum cassia: The bark of Cinnamomum cassia Presl of the Rutaceae family Cinnamomum cassiaThe bark of the tree is pungent, sweet and very hot. It enters the kidney, spleen, heart and liver meridians, warms the meridians and dredges the vessels, and helps yang and transforms qi. It is used for cold blood stagnation, chest pain, cold pain in the abdomen, vomiting and diarrhea due to deficiency and cold, etc.

[0023] Cistanche deserticola: Orobanchaceae plant Cistanche deserticola ( Cistanche deserticola The fleshy stem of YC Ma is sweet, salty and warm. It enters the kidney and large intestine meridians, warms and replenishes kidney yang, benefits essence and blood, moistens the intestines and promotes bowel movements. It is used for impotence due to kidney deficiency, cold pain in the waist and knees, weakness of tendons and bones, dry intestines and constipation, etc.

[0024] Yinqishi: A silicate amphibole mineral, salty and warm. It enters the kidney meridian, warms and nourishes the gate of life, warms the kidney and helps yang. It is used for kidney yang deficiency, impotence, cold uterus, cold pain in waist and knees, etc.

[0025] Rehmannia glutinosa: Rehmannia glutinosa ( Rehmannia glutinosa Libosch.) is processed and made into a sweet, slightly warm root. It enters the liver and kidney meridians, nourishes yin and blood, replenishes essence and fills the marrow. It is used for liver and kidney yin deficiency, soreness of waist and knees, dizziness, tinnitus and deafness, etc.

[0026] Morinda officinalis: Rubiaceae plant Morinda officinalis ( Morinda officinalis How.) The dried root is pungent, sweet and warm. It enters the kidney and liver meridians, replenishes kidney yang, strengthens tendons and bones, and removes rheumatism. It is used for kidney yang deficiency, impotence and spermatorrhea, uterine cold and infertility, rheumatic pain, etc.

[0027] Deer antler glue: The antlers of sika deer or red deer, which are decocted in water, are sweet, salty and warm. They enter the kidney and liver meridians, warm and tonify kidney yang, replenish essence and blood. They are used for kidney yang deficiency, insufficient essence and blood, impotence and premature ejaculation, cold uterus and infertility, etc.

[0028] Salvia miltiorrhiza: Salvia miltiorrhiza (Lamiaceae) Salvia miltiorrhiza Bunge.) Dried root and rhizome, bitter, slightly cold. Enter the heart and liver meridians, promote blood circulation and remove blood stasis, cool blood and eliminate carbuncle. Used for blood stasis, chest pain, irregular menstruation, dysmenorrhea and amenorrhea.

[0029] Cornus officinalis: Cornus officinalis ( Cornus officinalis Sieb. et Zucc. ) is sour, astringent and slightly warm. It enters the liver and kidney meridians, nourishes the liver and kidneys, and is astringent and astringent. It is used for liver and kidney yin deficiency, soreness of the waist and knees, dizziness, spermatorrhea, metrorrhagia, and leukorrhea.

[0030] Wolfberry: Solanaceae plant wolfberry ( Lycium barbarum L.) The dried mature fruit is sweet and neutral. It enters the liver and kidney meridians, nourishes the liver and kidneys, improves the essence and improves eyesight. It is used for liver and kidney yin deficiency, soreness of the waist and knees, dizziness, blurred vision, and cough due to consumptive disease.

[0031] Curculigo: Curculigo of the Amaryllidaceae family ( Curculigo orchioidesThe dry rhizome of Aconitum carmichaelii Debx., pungent and hot. It belongs to the kidney and liver meridians, warming the kidney and strengthening yang, dispelling cold and removing dampness. It is used for yang deficiency, impotence and spermatorrhea, infertility due to cold uterus, soreness and cold pain in the waist and knees, etc.

[0032] Moutan Bark: The dry root bark of Paeonia suffruticosa Andr. of the Ranunculaceae family, bitter, pungent, slightly cold. It belongs to the heart, liver and kidney meridians, clearing heat and cooling blood, promoting blood circulation and removing stasis. It is used for epidemic febrile disease with maculae, hematemesis and epistaxis, feverish sensation in the evening and early morning coolness, bone steaming without sweating, amenorrhea and dysmenorrhea, carbuncles and sores, etc. Paeonia suffruticosa Astragalus membranaceus (Fisch.) Bunge of the Leguminosae family, sweet, slightly warm. It belongs to the spleen and lung meridians, replenishing qi and raising yang, benefiting qi and strengthening the exterior, promoting diuresis and relieving edema. It is used for qi deficiency and weakness, poor appetite and loose stools, middle qi sinking, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, qi deficiency edema, etc.

[0033] Astragalus membranaceus (Fisch.) Bunge of the Leguminosae family Astragalus membranaceus (Fisch.) Bunge., dry root, sweet, slightly warm. It belongs to the spleen and lung meridians, replenishing qi and raising yang, benefiting qi and strengthening the exterior, promoting diuresis and relieving edema. It is used for qi deficiency and weakness, poor appetite and loose stools, middle qi sinking, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, qi deficiency edema, etc.

[0034] Example 1 Weigh 15 g of Aconitum carmichaelii Debx., 10 g of Cinnamomum cassia Presl, 15 g of Cistanche deserticola Ma, 20 g of Actinolitum, 25 g of Rehmannia glutinosa Libosch., 15 g of Cornus officinalis Sieb. et Zucc., 15 g of Lycium barbarum L., 10 g of Curculigo orchioides Gaertn., 15 g of Moutan Bark, pulverize them, add a mixture of 0.5 g of laccase and cellulase, the mass ratio of laccase to cellulase is 1:1, add 1 L of water, enzymatically hydrolyze at 55 °C for 48 h; then use water as the solvent (the solid-liquid ratio is 1:5), ultrasonically extract at 55 °C for 60 min to obtain the water extract.

[0035] Weigh 20 g of Epimedium brevicornu Maxim., 20 g of Psoralea corylifolia L., 10 g of Morinda officinalis How, 15 g of Colla Corni Cervi, 15 g of Salvia miltiorrhiza Bunge, 20 g of Astragalus membranaceus (Fisch.) Bunge, pulverize them, add a mixture of 0.5 g of laccase and cellulase, the mass ratio of laccase to cellulase is 1:1, add 1 L of water, enzymatically hydrolyze at 55 °C for 48 h; then use 75% ethanol solution as the solvent (the solid-liquid ratio is 1:5), ultrasonically extract at 60 °C for 40 min to obtain the ethanol extract.

[0036] Combine the water extract and the ethanol extract to obtain the traditional Chinese medicine complex.

[0037] Example 2 Weigh 5 g of Aconitum carmichaelii Debx., 10 g of Cinnamomum cassia Presl, 25 g of Cistanche deserticola Ma, 10 g of Actinolitum, 25 g of Rehmannia glutinosa Libosch., 10 g of Cornus officinalis Sieb. et Zucc., 10 g of Lycium barbarum L., 10 g of Curculigo orchioides Gaertn., 10 g of Moutan Bark, pulverize them, add a mixture of 0.5 g of laccase and cellulase, the mass ratio of laccase to cellulase is 1:2, add 1 L of water, enzymatically hydrolyze at 50 °C for 48 h; then use water as the solvent (the solid-liquid ratio is 1:5), ultrasonically extract at 50 °C for 60 min to obtain the water extract.

[0038] Weigh 40 g of Epimedii Folium, 10 g of Psoraleae Fructus, 20 g of Morindae Officinalis Radix, 20 g of Cornu Cervi Colla, 25 g of Salviae Miltiorrhizae Radix, and 30 g of Astragali Radix. After pulverizing, add a mixture of 0.5 g of laccase and cellulase, with the mass ratio of laccase to cellulase being 1:1. Add 1 L of water and enzymatically hydrolyze at 55 °C for 48 h; then use a 75% ethanol solution as the solvent (material-liquid ratio is 1:5), and perform ultrasonic extraction at 50 °C for 50 min to obtain an ethanol extract.

[0039] Combine the water extract and the ethanol extract to obtain a traditional Chinese medicine complex.

[0040] Example 3 Weigh 20 g of Aconiti Lateralis Radix Preparata, 10 g of Cinnamomi Cortex, 25 g of Cistanches Herba, 30 g of Actinolitum, 35 g of Rehmanniae Radix Preparata, 25 g of Corni Fructus, 25 g of Lycii Fructus, 20 g of Curculiginis Rhizoma, and 25 g of Moutan Cortex. After pulverizing, add a mixture of 0.5 g of laccase and cellulase, with the mass ratio of laccase to cellulase being 1:2. Add 1 L of water and enzymatically hydrolyze at 60 °C for 42 h; then use water as the solvent (material-liquid ratio is 1:5), and perform ultrasonic extraction at 60 °C for 40 min to obtain a water extract.

[0041] Weigh 20 g of Epimedii Folium, 10 g of Psoraleae Fructus, 15 g of Morindae Officinalis Radix, 20 g of Cornu Cervi Colla, 10 g of Salviae Miltiorrhizae Radix, and 15 g of Astragali Radix. After pulverizing, add a mixture of 0.5 g of laccase and cellulase, with the mass ratio of laccase to cellulase being 1:1. Add 1 L of water and enzymatically hydrolyze at 60 °C for 42 h; then use a 75% ethanol solution as the solvent (material-liquid ratio is 1:5), and perform ultrasonic extraction at 50 °C for 50 min to obtain an ethanol extract.

[0042] Combine the water extract and the ethanol extract to obtain a traditional Chinese medicine complex.

[0043] Comparative Example 1 Weigh 15 g of Aconiti Lateralis Radix Preparata, 20 g of Epimedii Folium, 20 g of Psoraleae Fructus, 10 g of Cinnamomi Cortex, 15 g of Cistanches Herba, 20 g of Actinolitum, 25 g of Rehmanniae Radix Preparata, 10 g of Morindae Officinalis Radix, 15 g of Cornu Cervi Colla, 15 g of Salviae Miltiorrhizae Radix, 15 g of Corni Fructus, 15 g of Lycii Fructus, 10 g of Curculiginis Rhizoma, 15 g of Moutan Cortex, and 20 g of Astragali Radix. Add 1 L of water and soak for 30 min, then bring to a boil over high heat, turn to low heat and simmer for 30 min, filter to obtain the first decoction and the medicinal residue; add 800 mL of clear water to the medicinal residue, bring to a boil over high heat, then turn to low heat and simmer for 25 min, filter to obtain the second decoction, and combine the first decoction and the second decoction to obtain a medicinal liquid.

[0044] Comparative Example 2 Weigh 15 g of Aconiti Lateralis Radix Preparata, 10 g of Cinnamomi Cortex, 15 g of Cistanches Herba, 20 g of Actinolitum, 25 g of Rehmanniae Radix Preparata, 15 g of Corni Fructus, 15 g of Lycii Fructus, 10 g of Curculiginis Rhizoma, and 15 g of Moutan Cortex. After pulverizing, use water as the solvent (material-liquid ratio is 1:5), and perform ultrasonic extraction at 55 °C for 60 min to obtain a water extract.

[0045] Weigh 20 g of Epimedii Folium, 20 g of Psoraleae Fructus, 10 g of Morindae Officinalis Radix, 15 g of Cornu Cervi Colla, 15 g of Salviae Miltiorrhizae Radix, and 20 g of Astragali Radix. After pulverization, use 75% ethanol solution as the solvent (material-liquid ratio is 1:5), and perform ultrasonic extraction at 60 °C for 40 min to obtain an ethanol extract.

[0046] Combine the water extract and the ethanol extract to obtain a traditional Chinese medicine complex.

[0047] Control Example 3 Weigh 15 g of Aconiti Lateralis Radix Preparata, 10 g of Cinnamomi Cortex, 15 g of Cistanches Herba, 20 g of Actinolitum, 25 g of Rehmanniae Radix Praeparata, 15 g of Corni Fructus, 15 g of Lycii Fructus, 10 g of Curculiginis Rhizoma, and 15 g of Moutan Cortex. After pulverization, add 0.5 g of cellulase, add 1 L of water, and perform enzymatic hydrolysis at 55 °C for 48 h; then use water as the solvent (material-liquid ratio is 1:5), and perform ultrasonic extraction at 55 °C for 60 min to obtain a water extract.

[0048] Weigh 20 g of Epimedii Folium, 20 g of Psoraleae Fructus, 10 g of Morindae Officinalis Radix, 15 g of Cornu Cervi Colla, 15 g of Salviae Miltiorrhizae Radix, and 20 g of Astragali Radix. After pulverization, add 0.5 g of cellulase, add 1 L of water, and perform enzymatic hydrolysis at 55 °C for 48 h; then use 75% ethanol solution as the solvent (material-liquid ratio is 1:5), and perform ultrasonic extraction at 60 °C for 40 min to obtain an ethanol extract.

[0049] Combine the water extract and the ethanol extract to obtain a traditional Chinese medicine complex.

[0050] Control Example 4 Weigh 15 g of Aconiti Lateralis Radix Preparata, 10 g of Cinnamomi Cortex, 15 g of Cistanches Herba, 20 g of Actinolitum, 25 g of Rehmanniae Radix Praeparata, 15 g of Corni Fructus, 15 g of Lycii Fructus, 10 g of Curculiginis Rhizoma, and 15 g of Moutan Cortex. After pulverization, add 0.5 g of laccase, add 1 L of water, and perform enzymatic hydrolysis at 55 °C for 48 h; then use water as the solvent (material-liquid ratio is 1:5), and perform ultrasonic extraction at 55 °C for 60 min to obtain a water extract.

[0051] Weigh 20 g of Epimedii Folium, 20 g of Psoraleae Fructus, 10 g of Morindae Officinalis Radix, 15 g of Cornu Cervi Colla, 15 g of Salviae Miltiorrhizae Radix, and 20 g of Astragali Radix. After pulverization, add 0.5 g of laccase, add 1 L of water, and perform enzymatic hydrolysis at 55 °C for 48 h; then use 75% ethanol solution as the solvent (material-liquid ratio is 1:5), and perform ultrasonic extraction at 60 °C for 40 min to obtain an ethanol extract.

[0052] Combine the water extract and the ethanol extract to obtain a traditional Chinese medicine complex.

[0053] Control Example 5 Weigh 15 g of red ginseng, 10 g of cinnamon, 15 g of cistanche, 20 g of actinolite, 25 g of rehmannia root, 15 g of cornelian cherry, 15 g of wolfberry fruit, 10 g of curculigo rhizome, and 15 g of moutan bark. After pulverization, add a mixture of 0.5 g of laccase and cellulase, with the mass ratio of laccase to cellulase being 1:1. Add 1 L of water and enzymatically hydrolyze at 55 °C for 48 h; then use water as the solvent (material-to-liquid ratio is 1:5), and perform ultrasonic extraction at 55 °C for 60 min to obtain the water extract.

[0054] Weigh 20 g of epimedium, 20 g of psoralea fruit, 10 g of morinda officinalis, 15 g of deer horn glue, 15 g of salvia miltiorrhiza, and 20 g of astragalus membranaceus. After pulverization, add a mixture of 0.5 g of laccase and cellulase, with the mass ratio of laccase to cellulase being 1:1. Add 1 L of water and enzymatically hydrolyze at 55 °C for 48 h; then use 75% ethanol solution as the solvent (material-to-liquid ratio is 1:5), and perform ultrasonic extraction at 60 °C for 40 min to obtain the ethanol extract.

[0055] Combine the water extract and the ethanol extract to obtain the traditional Chinese medicine complex.

[0056] Control Example 6 Weigh 15 g of aconite root, 10 g of cassia twig, 15 g of cistanche, 20 g of actinolite, 25 g of rehmannia root, 15 g of cornelian cherry, 15 g of wolfberry fruit, 10 g of curculigo rhizome, and 15 g of moutan bark. After pulverization, add a mixture of 0.5 g of laccase and cellulase, with the mass ratio of laccase to cellulase being 1:1. Add 1 L of water and enzymatically hydrolyze at 55 °C for 48 h; then use water as the solvent (material-to-liquid ratio is 1:5), and perform ultrasonic extraction at 55 °C for 60 min to obtain the water extract.

[0057] Weigh 20 g of epimedium, 20 g of psoralea fruit, 10 g of morinda officinalis, 15 g of deer horn glue, 15 g of salvia miltiorrhiza, and 20 g of astragalus membranaceus. After pulverization, add a mixture of 0.5 g of laccase and cellulase, with the mass ratio of laccase to cellulase being 1:1. Add 1 L of water and enzymatically hydrolyze at 55 °C for 48 h; then use 75% ethanol solution as the solvent (material-to-liquid ratio is 1:5), and perform ultrasonic extraction at 60 °C for 40 min to obtain the ethanol extract.

[0058] Combine the water extract and the ethanol extract to obtain the traditional Chinese medicine complex.

[0059] Control Example 7 Weigh 15 g of aconite root, 10 g of cinnamon, 15 g of cistanche, 20 g of actinolite, 25 g of rehmannia root, 15 g of cornelian cherry, 15 g of wolfberry fruit, 10 g of curculigo rhizome, and 15 g of moutan bark. After pulverization, add a mixture of 0.5 g of laccase and cellulase, with the mass ratio of laccase to cellulase being 1:1. Add 1 L of water and enzymatically hydrolyze at 55 °C for 48 h; then use water as the solvent (material-to-liquid ratio is 1:5), and perform ultrasonic extraction at 55 °C for 60 min to obtain the water extract.

[0060] Weigh 20 g of Dipsaci Radix, 20 g of Psoraleae Fructus, 10 g of Morindae Officinalis Radix, 15 g of Cornu Cervi Colla, 15 g of Salviae Miltiorrhizae Radix, and 20 g of Astragali Radix. After pulverization, add a mixture of 0.5 g of laccase and cellulase, with the mass ratio of laccase to cellulase being 1:1. Add 1 L of water and enzymatically hydrolyze at 55 °C for 48 h. Then, using a 75% ethanol solution as the solvent (material-liquid ratio of 1:5), perform ultrasonic extraction at 60 °C for 40 min to obtain the ethanol extract.

[0061] Combine the water extract and the ethanol extract to obtain the traditional Chinese medicine complex.

[0062] Test Example 1 Select male rats with good sexual function. Force the rats to swim until exhaustion (about 30 minutes) every day. At the same time, cage each male rat with 5 estrous female rats and change the female rats every day to induce excessive sexual activity and continuously establish the model for 8 weeks to simulate the symptoms of clinical kidney yang deficiency.

[0063] After successful model establishment, the rats showed manifestations such as soreness and weakness in the waist and knees (decreased grasping force), fear of cold and cold limbs (decreased anal temperature, reduced blood flow in the tail microcirculation), decreased libido (weakened capture and mounting behaviors), listlessness (decreased spontaneous activity), and dull fur. Divide the model rats into 5 experimental groups, a positive control group, and a negative control group, and treat them as follows: Group 1: Use the traditional Chinese medicine complex prepared in Example 1 as the medicament and administer it to the rats at a dose of 5 mg / g body weight, once a day by gavage. Group 2: Use the traditional Chinese medicine complex prepared in Comparative Example 1 as the medicament and administer it to the rats at a dose of 5 mg / g body weight, once a day by gavage. Group 3: Use the traditional Chinese medicine complex prepared in Comparative Example 2 as the medicament and administer it to the rats at a dose of 5 mg / g body weight, once a day by gavage. Group 4: Use the traditional Chinese medicine complex prepared in Comparative Example 3 as the medicament and administer it to the rats at a dose of 5 mg / g body weight, once a day by gavage. Group 5: Use the traditional Chinese medicine complex prepared in Comparative Example 4 as the medicament and administer it to the rats at a dose of 5 mg / g body weight, once a day by gavage. Group 6: Use the traditional Chinese medicine complex prepared in Comparative Example 5 as the medicament and administer it to the rats at a dose of 5 mg / g body weight, once a day by gavage. Group 7: Use the traditional Chinese medicine complex prepared in Comparative Example 6 as the medicament and administer it to the rats at a dose of 5 mg / g body weight, once a day by gavage. Group 8: Use the traditional Chinese medicine complex prepared in Comparative Example 7 as the medicament and administer it to the rats at a dose of 5 mg / g body weight, once a day by gavage. Positive control group: Use the traditional Chinese medicine formula Jinkui Shenqi Pills as the medicament and administer it to the rats at a dose of 5 mg / g body weight, once a day. Negative control group: Rats were gavaged with normal saline at a dose of 5 mg / g body weight once a day.

[0064] After four weeks of administration, the body weights of the rats in Groups 1-5 and the positive control group gradually recovered and no longer decreased continuously, and manifestations such as increased body temperature, restored grasping force, increased activity, and changes in sexual behavior (increased mounting times and shortened latency) occurred, indicating that the traditional Chinese medicine composition provided by the present invention has the effect of warming and tonifying the kidney yang and can improve the constitution of rats with kidney yang deficiency.

[0065] After the observation, the rats were anesthetized with 3% sodium pentobarbital, fixed on the operating board, the lower abdomen and penile region were fully exposed, the skin was incised along the midline of the lower abdomen of the rats to expose the corpus cavernosum penis, the tissues around the penis were gently separated to expose the corpus cavernosum penis, and care was taken to avoid damaging blood vessels and nerves. A 10 mL syringe needle connected to a PE-50 tube was inserted into the corpus cavernosum penis and pre-filled with 1% heparin saline to prevent blood reflux and coagulation. Puncture was performed on the dorsal side of the corpus cavernosum penis, the needle was inserted into the corpus cavernosum to ensure accurate needle position and avoid damaging the corpus cavernosum tissue. The PE-50 tube was connected to a pressure sensor or pressure recorder, and a bipolar electrical stimulation hook was connected to a programmable stimulator. The electrical stimulation parameters were set as: voltage 5 V, frequency 15 Hz, pulse width 5 ms. The electrical stimulation hook was placed near the cavernous nerve, stimulated for 1 minute, and ICP data were recorded. The changes in ICP were observed in real time through the pressure sensor or recorder, and the peak value of ICP was statistically analyzed. Each rat was stimulated and recorded 5 times repeatedly, and the average value was taken as the final result. The results are shown in Table 1.

[0066] Table 1 Peak ICP of rats (mmHg)

[0067] As can be seen from Table 1, compared with the negative control group, the peak ICP of the rats in Groups 1-5 was significantly increased, indicating that the traditional Chinese medicine composition provided by the present invention can effectively treat erectile dysfunction model rats; the peak ICP of the rats in Group 1 was higher than that of the rats in Groups 2-5, indicating that the traditional Chinese medicine composition prepared by the method provided by the present invention has higher activity and better therapeutic effect than other extraction methods; the peak ICP of the rats in Group 1 was generally higher than that of the rats in Groups 6-8, indicating that the compatibility effect of the traditional Chinese medicine composition provided by the present invention is better, and even if other traditional Chinese medicines with similar effects are used, the effect of the traditional Chinese medicine composition of the present invention cannot be achieved.

[0068] Test Example 2 Construct a rat model of kidney-yang deficiency type dysfunction according to the method described in Test Example 1. After the successful construction of the model, the rats showed symptoms such as weakness in the waist and knees (decreased grasping force), fear of cold and cold limbs (decreased anal temperature, reduced blood flow in the tail microcirculation), decreased libido (weakened capture and mounting behaviors), listlessness (decreased spontaneous activity), and dull fur. Divide the model rats into a low-dose group, a medium-dose group, a high-dose group, a positive control group, and a negative control group, and treat them as follows: Low-dose group: Use the traditional Chinese medicine complex prepared in Example 1 as the medicament, and administer it to the rats at a dose of 1 mg / g body weight, once a day by gavage; Medium-dose group: Use the traditional Chinese medicine complex prepared in Example 1 as the medicament, and administer it to the rats at a dose of 3 mg / g body weight, once a day by gavage; High-dose group: Use the traditional Chinese medicine complex prepared in Example 1 as the medicament, and administer it to the rats at a dose of 5 mg / g body weight, once a day by gavage; Negative control group: Administer normal saline to the rats at a dose of 5 mg / g body weight by gavage, once a day.

[0069] After continuous administration for 4 weeks, record the general signs of the rats such as body weight change, hair luster, and activity, and observe whether there are abnormal behaviors.

[0070] Euthanize the rats, perform HE staining on the liver, kidneys, and spleen, and observe whether there is tissue damage.

[0071] Results Compared with the negative control group, the rats in each dose group did not show significant toxic reactions (weight loss, decreased activity, reduced movement), and no tissue damage was found from the HE staining results, indicating that the traditional Chinese medicine composition provided by the present invention has good safety.

[0072] Although the above embodiments have described the present invention in detail, they are only a part of the embodiments of the present invention, not all of them. People can also obtain other embodiments based on these embodiments without creative efforts, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for male sexual dysfunction caused by kidney-yang deficiency, characterized in that, In parts by mass, the traditional Chinese medicine complex comprises the following components: 5 - 30 parts of aconite lateralis preparata, 10 - 40 parts of epimedium, 10 - 30 parts of psoralea corylifolia, 3 - 15 parts of cassia bark, 5 - 35 parts of cistanche deserticola, 10 - 50 parts of actinolite, 10 - 35 parts of rehmannia glutinosa, 5 - 25 parts of morinda officinalis, 5 - 30 parts of deer horn glue, 5 - 35 parts of salvia miltiorrhiza, 5 - 35 parts of cornel fruit, 5 - 35 parts of wolfberry fruit, 6 - 25 parts of curculigo orchioides, 5 - 35 parts of moutan bark, 10 - 40 parts of astragalus membranaceus.

2. The traditional Chinese medicine composition according to claim 1, wherein In parts by mass, the traditional Chinese medicine complex comprises the following components: 5 - 20 parts of aconite lateralis preparata, 20 - 40 parts of epimedium, 10 - 20 parts of psoralea corylifolia, 5 - 10 parts of cassia bark, 10 - 25 parts of cistanche deserticola, 10 - 30 parts of actinolite, 20 - 35 parts of rehmannia glutinosa, 15 - 20 parts of morinda officinalis, 10 - 20 parts of deer horn glue, 10 - 25 parts of salvia miltiorrhiza, 10 - 25 parts of cornel fruit, 10 - 25 parts of wolfberry fruit, 10 - 20 parts of curculigo orchioides, 10 - 25 parts of moutan bark, 15 - 30 parts of astragalus membranaceus.

3. A traditional Chinese medicine complex prepared from the traditional Chinese medicine composition according to claim 1 or claim 2, characterized in that, The preparation method of the traditional Chinese medicine complex comprises the following steps: After aconite lateralis preparata, cassia bark, cistanche deserticola, actinolite, rehmannia glutinosa, cornel fruit, wolfberry fruit, curculigo orchioides and moutan bark are pulverized, a first pulverized product is obtained. The first pulverized product is mixed with laccase and cellulase for primary enzymatic hydrolysis. After the primary enzymatic hydrolysis is completed, water is used as a solvent for primary ultrasonic extraction to obtain an aqueous extract. After epimedium, psoralea corylifolia, morinda officinalis, deer horn glue, salvia miltiorrhiza and astragalus membranaceus are pulverized, a second pulverized product is obtained. The second pulverized product is mixed with laccase and cellulase for primary enzymatic hydrolysis. After the primary enzymatic hydrolysis is completed, a 75% ethanol solution is used as a solvent for secondary ultrasonic extraction to obtain an ethanol extract. The aqueous extract and the ethanol extract are combined to obtain the traditional Chinese medicine complex.

4. The traditional Chinese medicine complex according to claim 3, wherein, The mass ratio of the laccase to the cellulase is 1:1 - 2.

5. The traditional Chinese medicine complex according to claim 3, wherein The mass ratio of the total mass of the laccase and the cellulase to the mass of the first pulverized product is 1 - 5:100 - 200, and the mass ratio of the total mass of the laccase and the cellulase to the mass of the second pulverized product is 1 - 5:100 - 200.

6. The traditional Chinese medicine complex according to claim 3, wherein The temperature of the primary enzymatic hydrolysis is 50°C - 60°C, and the time of the primary enzymatic hydrolysis is 40 - 50 h.

7. The traditional Chinese medicine complex according to claim 3, wherein The material - liquid ratio of the primary ultrasonic extraction is 1:1 - 10; the temperature of the primary ultrasonic extraction is 50°C - 60°C, and the time is 40 - 60 min.

8. The traditional Chinese medicine complex according to claim 3, wherein The material - liquid ratio of the secondary ultrasonic extraction is 1:1 - 10; the temperature of the secondary ultrasonic extraction is 50°C - 70°C, and the time is 30 - 50 min.

9. A product for male sexual dysfunction caused by kidney-yang deficiency, characterized in that, The product comprises the traditional Chinese medicine complex according to any one of claims 3 - 8.

10. The product according to claim 9, wherein, The dosage forms of the product include decoction, paste, pill and powder.

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