A Chinese medicinal compound for treating prostatic hyperplasia and its preparation method

Abstract

The invention discloses a Chinese medicinal compound for treating prostate hyperplasia. The Chinese medicinal compound is prepared by extracting the following Chinese medicinal raw materials: 20-30 parts of mulberry leaves, 15-25 parts of white mulberry bark, 15-20 parts of Chinese wolfberry bark, 20-30 parts of platycodon, 10-20 parts of burdock seeds, 20-30 parts of schizonepeta, 8-12 parts of cinnamon bark, 5-8 parts of processed aconite, 15-25 parts of bupleurum, 5-15 parts of cyperus, 20-30 parts of tangerine peel, 20-30 parts of plantain seeds, 15-25 parts of desmodium herb, 20-30 parts of pyrrosia, 10-20 parts of gardenia, 8-12 parts of talc, 15-25 parts of scutellaria and 10-20 parts of phellodendron. The invention also discloses a preparation method thereof. The whole compound can relieve lung heat, open lung qi, achieve lung descending, regulate water channels, transport to the bladder and promote urination, so as to achieve the purpose of treating prostate hyperplasia.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound for treating prostate hyperplasia and a preparation method thereof. Background Art

[0002] Prostatic hypertrophy is also called benign prostatic hypertrophy or prostatic hyperplasia. In traditional Chinese medicine, it belongs to the category of stranguria and urethritis. This disease is a common disease in middle-aged and elderly men, and the incidence gradually increases with age. It is currently believed that its onset may be related to the imbalance of sex hormones or cholesterol accumulation in the elderly, or inflammation of the urinary system and pelvic congestion may also aggravate the symptoms. The main symptoms are frequent urination, difficulty in urination, acute urinary retention or urinary incontinence, and in the early stage, it is often only an increase in the number of nocturia. Prostatic hypertrophy, mild cases do not cause urinary tract obstruction and urinary disorders; severe cases, the number of urination increases at the beginning, which is more obvious at night, and with difficulty in urination, there is a feeling of incomplete urination. In severe cases, it takes a lot of effort to urinate, which can sometimes cause acute urinary retention. Traditional Chinese medicine treatment for prostate hyperplasia. Traditional Chinese medicine believes that the occurrence and development of the disease involves the lung, kidney and spleen, or is related to qi deficiency and blood stasis. In traditional Chinese medicine, the lung is the canopy. If the spleen fails to be expressed, it will be difficult to regulate downward. As the saying goes, the upper orifices are closed and the lower orifices are blocked. The spleen is the foundation of the acquired constitution. If the transportation and transformation are not powerful, the water will not flow, causing urine retention. Clinically, it is believed that dampness is heavy and damp heat is poured downward. As for clearing heat and promoting diuresis, Bazhengsan is added with flavor. Plantago, talcum powder, gardenia, rush, and licorice can be selected for treatment. If the poison is blocked, it can be cleared with heat, detoxified, and liver fire can be relieved. Longdan Xiegan Decoction is used, but the effect is not very good. Summary of the invention

[0003] Purpose of the invention: In order to solve the above problems, the purpose of the present invention is to provide a Chinese medicine compound for treating prostatic hyperplasia, and a preparation method and application thereof.

[0004] Technical solution: The purpose of the present invention is achieved through the following solution:

[0005] A traditional Chinese medicine compound for treating prostatic hyperplasia is prepared by extracting the following traditional Chinese medicine raw materials: 20-30 parts of mulberry leaves, 15-25 parts of white mulberry bark, 15-20 parts of Chinese wolfberry bark, 20-30 parts of platycodon, 10-20 parts of burdock seeds, 20-30 parts of schizonepeta, 8-12 parts of cinnamon bark, 5-8 parts of processed aconite, 15-25 parts of bupleurum, 5-15 parts of cyperus, 20-30 parts of tangerine peel, 20-30 parts of plantain seeds, 15-25 parts of desmodium herb, 20-30 parts of pyrrosia, 10-20 parts of gardenia, 8-12 parts of talc, 15-25 parts of scutellaria, and 10-20 parts of phellodendron.

[0006] The Chinese medicinal compound for treating prostatic hyperplasia is prepared by extracting the following Chinese medicinal raw materials: 25 parts of mulberry leaves, 20 parts of white mulberry bark, 18 parts of Chinese wolfberry bark, 25 parts of platycodon, 15 parts of burdock seeds, 25 parts of schizonepeta, 10 parts of cinnamon bark, 7 parts of processed aconite, 20 parts of bupleurum, 10 parts of cyperus, 25 parts of tangerine peel, 25 parts of plantain seeds, 20 parts of desmodium, 25 parts of pyrrosia, 15 parts of gardenia, 10 parts of talc, 20 parts of scutellaria, and 15 parts of phellodendron.

[0007] The Chinese medicinal compound for treating prostatic hyperplasia is prepared by extracting the following Chinese medicinal raw materials: 20 parts of mulberry leaves, 25 parts of white mulberry bark, 15 parts of Chinese wolfberry bark, 30 parts of platycodon, 10 parts of burdock seeds, 30 parts of schizonepeta, 8 parts of cinnamon bark, 8 parts of processed aconite, 15 parts of bupleurum, 15 parts of cyperus, 20 parts of tangerine peel, 30 parts of plantain seeds, 15 parts of desmodium, 30 parts of pyrrosia, 10 parts of gardenia, 12 parts of talc, 15 parts of scutellaria, and 20 parts of phellodendron.

[0008] The Chinese medicinal compound for treating prostatic hyperplasia is prepared by extracting the following Chinese medicinal raw materials: 30 parts of mulberry leaves, 15 parts of white mulberry bark, 20 parts of Chinese wolfberry bark, 20 parts of platycodon, 20 parts of burdock seeds, 20 parts of schizonepeta, 12 parts of cinnamon, 5 parts of processed aconite, 25 parts of bupleurum, 5 parts of cyperus, 30 parts of tangerine peel, 20 parts of plantain seeds, 25 parts of desmodium, 20 parts of pyrrosia, 20 parts of gardenia, 8 parts of talc, 25 parts of scutellaria, and 10 parts of phellodendron.

[0009] The Chinese medicinal compound for treating prostatic hyperplasia is prepared by:

[0010] (1) Extraction: Take talc and decoct for 1 hour, then add other raw materials, soak in water for 1 hour and decoct twice, each time for 1.5 hours. For the first decoction, add 10 times the amount of water of the medicinal materials, and for the second decoction, add 8 times the amount of water of the medicinal materials. The decoctions are filtered through a 100-mesh sieve and the two decoctions are combined;

[0011] (2) Concentration: taking the combined decoction from step (1), concentrating the decoction at a vacuum degree of -0.05 to -0.10 MPa and a temperature of 60 to 80° C., and controlling the relative density of the concentrated paste to be 1.10 to 1.20;

[0012] (3) Alcohol precipitation: Take the clear paste from step (2), add 95% ethanol, stir well to make the alcohol content of the solution reach 70%, and let it stand for 24 hours;

[0013] (4) recovering ethanol: taking the supernatant after standing in step (3), recovering ethanol and concentrating it to a clear paste having a relative density of 1.15 to 1.20 at 50° C.;

[0014] (5) Preparation of dry paste powder: Take the clear paste from step (4), spray dry it, grind it into dry paste powder, add auxiliary materials, and prepare it into a solid preparation.

[0015] The Chinese medicinal compound for treating prostatic hyperplasia, in the preparation method, the auxiliary materials include fillers, disintegrants, lubricants, and adhesives, the fillers include: one or more of starch, pregelatinized starch, mannitol, chitin, microcrystalline cellulose, and sucrose; the disintegrants include: one or more of starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl cellulose, cross-linked polyvinyl pyrrolidone, low-substituted hydroxypropyl cellulose, and cross-linked sodium carboxymethyl cellulose; the lubricants include: one or more of magnesium stearate, sodium lauryl sulfate, talc, and silicon dioxide; the adhesives include: one or more of starch slurry, polyvinyl pyrrolidone, and hydroxypropyl methylcellulose.

[0016] The Chinese medicinal compound for treating prostatic hyperplasia is of the lung-heat and qi-stagnation type.

[0017] Mulberry leaf is the dried leaf of the mulberry plant of the Moraceae family. It is also known as domestic mulberry, jing mulberry, mulberry tree, yellow mulberry leaf, etc. It is produced in most parts of the country. Mulberry leaf extract deoxynojirimycin is combined with flavonoids extracted from kudzu root to form a new substance - pancreatic clearing sugar, which is suitable for treating blood sugar, blood lipids, and anti-inflammatory effects. It is bitter and sweet in nature and cold in nature. It enters the lung and liver meridians. It can dispel wind-heat, clear the lungs and moisten dryness, calm the liver and improve eyesight, and cool blood and stop bleeding. It is used for wind-heat colds, early onset of febrile diseases, lung heat coughs, dizziness due to hyperactivity of liver yang, red and blurred eyes, and coughing and vomiting blood due to blood heat.

[0018] Morus alba bark is the dried root bark of the dicotyledonous plant Morus alba after removing the cork bark. It was first recorded in Shennong's Herbal Classic. It is sweet and cold in nature and belongs to the lung and spleen meridians. Morus alba bark has the effects of purging the lungs and relieving asthma, promoting water circulation and reducing swelling. It is mainly used to treat lung heat, asthma and cough, oliguria and edema, and swelling of the face and skin. Morus alba bark has a variety of modern pharmacological activities such as lowering blood pressure and anti-inflammatory. The functions mainly include: purging the lungs and relieving asthma, promoting water circulation and reducing swelling, tonifying deficiency, promoting blood circulation and removing blood stasis, resolving phlegm and stopping cough, stopping bleeding, promoting body fluid and quenching thirst, purging and relieving constipation, expelling parasites, digesting food, dispelling wind, relieving stranguria, and relieving pain.

[0019] Di Gu Pi, also known as Lycium bark, is a plant of the Solanaceae family and the Lycium genus. It is the root bark of Lycium chinense Mill. It can be used as medicine, and has the effects of reducing fever and removing steam, cooling blood and removing steam, clearing the lungs and reducing fire. "Ben Cao Shu" says: "It is mainly used to treat fever due to asthenia, alternating chills and fever, various blood syndromes, epistaxis, coughing up blood, coughing, wheezing, consumptive disease, stroke, dizziness, spasm, back pain, paralysis, beriberi, edema, restlessness, palpitations, forgetfulness, urinary obstruction, and red and white turbidity."

[0020] Platycodon grandiflorus (Jacq.) A.Dc. is a plant of the Campanulaceae family. It is harvested in spring and autumn, washed, the fibrous roots are removed, the skin is peeled while fresh or not, and dried. It grows on mountain grass slopes, forest edges, or is cultivated. It is distributed in various regions of the country. It has the effects of clearing the lungs, relieving sore throat, removing phlegm, and expelling pus. It is used for cough with phlegm, chest tightness, sore throat, hoarseness, and vomiting pus due to lung abscess.

[0021] Burdock seeds are the dried mature fruits of the biennial herbaceous plant Burdock of the Asteraceae family. They are oblong, slightly flat, slightly curved, 5 to 7 mm long and 2 to 3 mm wide. The surface is gray-brown with purple-black spots and several longitudinal ridges, usually 1 to 2 in the middle are more obvious. The top is blunt and slightly wide, with a ring on the top surface and a dot-shaped style remnant in the middle; the base is slightly narrow and the surface is lighter. The fruit skin is hard, with 2 cotyledons, light yellow-white, and rich in oil. Odorless, bitter and slightly spicy, and slightly numbing. When the fruit is ripe in autumn, the fruit sequence is harvested, dried, the fruit is beaten, impurities are removed, and then dried. It can be used raw or fried, and crushed when used. It has the effects of dispersing wind-heat, clearing the lungs and clearing rashes, relieving throat and dispersing knots, and detoxifying and reducing swelling. It belongs to the wind-heat dispersing medicine among the antipyretics. Modern research shows that burdock seeds can also be used to prevent and treat diabetic nephropathy. The arctiin generated by hydrolysis of arctiin contained in burdock fruit has anti-cancer activity.

[0022] Schizonepeta is the dried aerial part of Schizonepeta tenuifolia Briq., a plant of the Labiatae family. It is harvested in summer and autumn when the flowers have bloomed to the top and the spikes are green, and then the impurities are removed and dried in the sun. It is pungent and slightly warm in nature. It enters the lung and liver meridians. It can relieve the exterior wind, dissipate rashes, and eliminate sores. It is used for colds, headaches, measles, rubella, and the initial stage of sores. "Compendium of Materia Medica": It can dissipate wind and heat, and clear the head and eyes. It can be used as a pillow to dissipate wind in the head and neck; it can be taken with gypsum powder to dissipate wind and heat headache. "Ben Jing Feng Yuan": It can stop bleeding after childbirth, and can be used to make black urine from children. It is forbidden to eat pufferfish, all scaleless fish, and donkey meat; it can be taken after eating yellow croaker, which can make people vomit blood, but only ground pulp can relieve it. It can be eaten with crabs to cause wind. "Ben Cao Cong Xin": It can induce sweating. It can dissipate rheumatism. It can benefit the throat. It can clear the head and eyes. It can treat headache caused by typhoid fever. It can make the mouth lock after stroke. It can make the body strong and the neck straight.

[0023] Processed aconite is a processed product of the rootlets of Aconitum carmichaeli Debx., a plant of the Ranunculaceae family. It is dug from late June to early August, and the mother root, fibrous roots and mud and sand are removed. It is commonly known as "mud aconite". After being processed by salting, water bleaching, boiling, frying and other methods to reduce toxicity, it is called "processed aconite". It is pungent, sweet, very hot; toxic. It enters the heart, kidney and spleen meridians. It can restore yang and rescue adverse conditions, replenish fire and assist yang, and expel wind, cold and dampness. It is used for yang loss, collapse, cold limbs and weak pulse, impotence, cold uterus, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, edema due to yin and cold, exogenous infection due to yang deficiency, and arthralgia due to cold and dampness.

[0024] Cinnamon bark is the dried bark of Cinnamomum cassia Presl, a plant of the Lauraceae family. It is usually peeled in autumn and dried in the shade. It tastes spicy and sweet, and is very hot in nature. It enters the kidney, spleen, heart, and liver meridians. It has the effects of replenishing fire and yang, guiding fire back to the origin, dispersing cold and relieving pain, and warming and unblocking the meridians. It is used for impotence, cold uterus, cold pain in the waist and knees, asthma due to kidney deficiency, floating of false yang, dizziness and red eyes, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, abdominal pain due to cold hernia, and dysmenorrhea and amenorrhea.

[0025] Bupleurum is the dried root of the Umbelliferae plant Bupleurum or Bupleurum angustifolia. It is dug in spring and autumn, and the stems, leaves and mud are removed and dried. Bupleurum is a commonly used antipyretic. Also known as ground smoke, mountain vegetables, mushroom grass, and firewood, it is bitter and slightly cold in nature and enters the liver and gallbladder meridians. It has the effects of reconciling the exterior and interior, soothing the liver and raising yang. It is used for colds and fever, alternating colds and heat, malaria, liver depression and qi stagnation, chest and rib pain, rectal prolapse, uterine prolapse, and irregular menstruation. "Southern Yunnan Materia Medica": "Use Bupleurum to induce sweating in typhoid fever, and it can only be used after four days: if it is used first, the yang symptoms will be introduced into the yin meridian, and it should be avoided." "Ben Jing Feng Yuan": "Bupleurum is suitable for children with five malnutritions, weak fever, and various malaria cold and heat. After the smallpox appears, there is cold and heat, or pain and heat under the ribs, use it in the surface-penetrating medicine, so that the heat will not remain in the Shaoyang meridian, and there will be no teething problems in the future."

[0026] Cyperus rotundus is the dried rhizome of Cyperus rotundus, a plant of the Cyperaceae family. It is collected in autumn, burned to remove the hair, placed in boiling water and boiled briefly or steamed thoroughly and then dried, or burned and then dried directly. It tastes pungent, slightly bitter, slightly sweet, and neutral. It enters the liver, spleen, and triple burner meridians. It soothes the liver and relieves depression, regulates qi and relieves fullness, regulates menstruation and relieves pain. It is used for liver depression and qi stagnation, chest and flank distension and pain, hernia pain, breast distension and pain, spleen and stomach qi stagnation, abdominal distension, fullness and pain, irregular menstruation, amenorrhea and dysmenorrhea. "Compendium of Materia Medica Yanyi Buyi": Cyperus rotundus must be soaked in children's urine. It must be used for all blood and qi medicines. It leads to qi and produces blood. This is the meaning of yang giving birth to yin. Zhu Zhenheng: Cyperus rotundus, "Compendium of Materia Medica" does not mention tonic, but the prescription family says it is beneficial to the elderly, and the meaning is there, probably in the action with tonic theory.

[0027] Tangerine peel is the dried mature peel of the citrus plant (Citrus reticulata Blanco) and its cultivated varieties in the Rutaceae family. The medicinal material is divided into "Chenpi" and "Guangchenpi". Pick the ripe fruits, peel the peel, and dry them in the sun or at low temperature. It tastes bitter and pungent, and is warm in nature. It enters the lung and spleen meridians. It regulates qi and strengthens the spleen, dries dampness and resolves phlegm. It is used for abdominal distension, loss of appetite, vomiting and diarrhea, and cough with excessive phlegm. "Famous Doctors' Records": It can reduce qi and stop vomiting. "Compendium of Materia Medica": It can treat vomiting, nausea, vomiting of clear water from time to time.

[0028] Plantago seeds are the dried mature seeds of Plantago asiatica L. or Plantago depressa Willd. of the Plantaginaceae family. The seeds are harvested in summer and autumn when they are ripe, dried in the sun, and the seeds are rubbed out to remove impurities. It tastes sweet and is cold in nature. It enters the liver, kidney, lung, and small intestine meridians. It clears away heat, promotes diuresis, relieves stranguria, eliminates dampness and stops diarrhea, improves eyesight, and eliminates phlegm. It is used for painful stranguria caused by heat, edema, diarrhea caused by summer heat and dampness, red and swollen eyes, and cough caused by phlegm and heat.

[0029] Houttuynia cordata is the dried whole herb of Lysimachia christinae Hance, a plant of the Primulaceae family. It is distributed in Yunnan, Sichuan, Guizhou, Shaanxi (southern), Henan, Hubei, Hunan, Guangxi, Guangdong, Jiangxi, Anhui, Jiangsu, Zhejiang, Fujian and other places. It has the effects of removing dampness and jaundice, promoting diuresis and relieving stranguria, detoxifying and reducing swelling. It is often used for damp-heat jaundice, gallbladder distension and hypochondriacal pain, stranguria with stones, stranguria with heat, painful and astringent urination, carbuncle, furuncle, snake and insect bites.

[0030] Pyrrosia is the dried leaves of Pyrrosio, sheareri (Bak.) Ching, Pyrrosialingua (Thunb.) Farwell or Pyrrosia petiolosa (Christ) Ching of the Polypodiaceae family. It can be harvested throughout the year, and the rhizomes and roots are removed, and dried in the sun or in the shade. It tastes sweet and bitter, and is slightly cold in nature. It enters the lung and bladder meridians. It has the effects of diuresis, clearing the lungs and relieving cough, cooling blood and stopping bleeding. It is used for hot stranguria, blood stranguria, stone stranguria, urinary obstruction, dripping and painful, lung heat and cough, vomiting blood, epistaxis, hematuria, and metrorrhagia. "Shennong's Herbal Classic": It can treat heat evil qi, five kinds of stranguria, and blockage, and it can benefit the urinary tract. "Compendium of Materia Medica": It can treat metrorrhagia, wounds, and clear lung qi.

[0031] Gardenia is the fruit of the Rubiaceae plant Gardenia. The fruit of Gardenia is a traditional Chinese medicine and is included in the first batch of dual-purpose medicinal and edible resources issued by the Ministry of Health. It has the effects of protecting the liver, promoting bile secretion, lowering blood pressure, calming, stopping bleeding, and reducing swelling. It is often used in clinical Chinese medicine to treat icteric hepatitis, sprains, hypertension, diabetes, etc. It is bitter and cold. It enters the heart, lung, and triple burner meridians. It can purge fire and relieve restlessness, clear away heat and dampness, cool blood and detoxify; it can be used externally to reduce swelling and relieve pain. It is used for restlessness due to fever, jaundice due to damp heat, painful stranguria due to stranguria, vomiting and bleeding due to blood heat, red and swollen eyes, fire poison sores, and external treatment of sprains and pain. "Compendium of Materia Medica" states: "Zhongjing treated (typhoid fever) after sweating and vomiting, and the patient was restless and unable to sleep. If the condition is severe, the patient will be in a state of confusion and upset. Gardenia and Fermented Soya Bean Soup was used to treat it. Rhubarb is not used because it is weak, as it has a cold toxicity. Although gardenia is cold and non-toxic, it can treat heat in the stomach, which causes loss of blood and body fluids, lack of nourishment to the internal organs, and internal heat. This must be removed. It can also treat heat retention in the heart meridian and astringent urination. Use peeled gardenia, simmered rhubarb, forsythia, and licorice (roasted), divide them into equal parts, grind them into powder, decoct them in water for three qian and take it with no adverse effects." "Tangye Materia Medica" states: "Gardenia may be used to promote urination, but it is not actually used to promote urination, but to clear the lungs. The lung qi is clear and transformed, and the bladder is the place where body fluids are stored. Urine is expelled by the transformation of this qi. Gardenia and Fermented Soybean Soup is used to treat restlessness. Restlessness is qi, and restlessness is blood. Qi governs the lungs, and blood governs the kidneys. Therefore, gardenia is used to treat lung restlessness, and fermented soy beans are used to treat kidney restlessness. Restlessness is caused by melancholy and insomnia. "Compendium of Materia Medica" says: "Gardenia clears the heat of Shaoyin, and then the evil qi in the five internal organs will go away, and the heat in the stomach will also be removed. Red face, wine blisters, and nasal congestion are signs of lung heat. The lungs are responsible for clearing and clearing, and wine heat invades them, so this symptom is seen. The face is extended to the opening of the orifices. The lungs receive bitter and cold qi, so the wine heat will go away and the redness of the face and nose will all disappear. It is used to treat red and white leprosy, sores, and ulcers. , that is, all pains, itches, sores and ulcers are caused by heart fire. It can treat red and hot pain in the eyes, severe heat in the chest, heart, large and small intestines, and depression in the heart, and it can eliminate the heat in the heart and lung meridians. This medicine tastes bitter and cold, and it can purge all excess fire, so it can treat the above symptoms. "Gardenia has a very bitter and cold nature, which damages the stomach and blood. People with weak spleen and stomach should avoid it, and those with blood deficiency and fever should avoid it. It can purge excess fire, so it is not suitable for people without evil heat in the heart and lungs; it is not suitable for people with urinary obstruction due to the lack of qi in the bladder to transform, but not for those with heat in the small intestine; sores and ulcers cannot be contracted due to deficiency of qi and blood, so they are long-term cold sores, and cannot be treated with warming and nourishing medicine. If you take medicine, it will not heal. This is what is meant by "after the ulcer has been ruptured, not even a bit of cold medicine can be used". People in the world also use it to treat various blood diseases, but they don't know that blood flows when it is hot and coagulates when it is cold. Stagnant blood coagulates in the body, which can cause cold and heat, or fever, fatigue, cough, and reduced appetite. It is a difficult disease to treat. All methods for treating vomiting blood should be based on smoothing the qi first, because blood flows with qi, and when qi descends, fire descends, and when fire descends, blood returns to the meridians. It stops without seeking to stop. This is the key method of treatment and cannot be violated. "Compendium of Materia Medica Chongyuan": "It is said that gardenia can cause vomiting when used raw, but not when fried until black. Gardenia and Douchi soup is used as an emetic. I have used raw gardenia and gardenia and Douchi soup, but I have never vomited.

[0032] Talc has the effects of diuresis, clearing away heat and relieving summer heat, and absorbing moisture and healing sores. This product has adsorption and astringency effects, and can protect the intestinal wall when taken orally. Talc powder is spread on the wound surface to form a membrane, which protects the wound surface, absorbs secretions, and promotes scab formation.

[0033] Scutellaria baicalensis is a perennial herbaceous plant of the genus Scutellaria in the family Lamiaceae. It has a thick fleshy rhizome, hard and papery leaves, lanceolate to linear-lanceolate, and a terminal raceme on the stems and branches. The corolla is purple, purple-red to blue, with flat filaments, slender styles, annular discs, brown ovaries, and ovoid nuts. The flowering and fruiting period is from July to September. Scutellaria baicalensis grows on sunny grassy slopes at an altitude of 60 to 1,300 (1,700 to 2,000) meters. It is produced in Heilongjiang, Liaoning, Inner Mongolia, Hebei, Henan, Gansu, Shaanxi, Shanxi, Shandong, Sichuan and other places, and can be planted in most provinces and regions in northern China. Its root is used as medicine, which tastes bitter and is cold in nature. It has the effects of clearing away heat and dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is mainly used to treat febrile diseases, upper respiratory tract infections, lung heat cough, damp-heat jaundice, pneumonia, dysentery, hemoptysis, red eyes, restless fetus, hypertension, carbuncle, furuncle, etc. The clinical antibacterial property of Scutellaria baicalensis is better than that of Coptis chinensis, and it does not produce drug resistance. "Compendium of Materia Medica": It treats wind-heat damp-heat headache, running pig heat pain, fire cough lung atrophy throat fishy, ​​and various blood loss. "Bie Lu": It treats phlegm heat and stomach heat, lower abdominal colic, digestion, small intestine, female blood retention, stranguria, and children's abdominal pain. "Ben Jing": It treats various heat jaundice, intestinal diarrhea, expelling water, blood retention, malignant sores, ulcers, erosions, and fire ulcers. "Ben Jing Feng Yuan": It is bitter and cold, non-toxic. The hollow ones are dried Scutellaria baicalensis and enter the lungs, and the thin and solid ones are Zi Scutellaria baicalensis and enter the large intestine. They are cooked and fried with wine.

[0034] Phellodendron chinense Schneid. is a dried bark of the Rutaceae plant. It is commonly known as "Sichuan Phellodendron". After peeling the bark, remove the rough skin and dry it in the sun. It tastes bitter and is cold in nature. It enters the kidney and bladder meridians. It has the effects of clearing heat and dampness, purging fire and removing steam, detoxifying and curing sores. It is used for damp-heat diarrhea, jaundice, red urine, leucorrhea, itching, hot stranguria, beriberi, bone steaming, fatigue, night sweats, spermatorrhea, sores, swelling and poison, eczema and wet sores. Salted Phellodendron nourishes yin and reduces fire. It is used for yin deficiency and fire, night sweats and bone steaming. "Treatise on Febrile Diseases": Phellodendron, Gardenia, Licorice. Treats yellow body and fever due to typhoid fever. "Fu Qingzhu's Gynecology": Phellodendron, Chinese yam, Plantago seed, Euryale ferox, Ginkgo. Treats damp heat in the lower jiao and leucorrhea.

[0035] Analysis of TCM compatibility theory: The occurrence of prostatic hyperplasia is closely related to the dysfunction of the lung, spleen, liver, kidney, triple energizer, and viscera. The failure of the upper energizer to transform qi should be blamed on the lung. If the lung fails to clear and purify, it cannot regulate the water channel and transport it to the bladder. The failure of the middle energizer to transform qi should be blamed on the spleen. If the spleen fails to function properly, it cannot raise the clear and lower the turbid. The failure of the lower energizer to transform qi should be blamed on the kidney. If the kidney yang is deficient, the qi cannot transform into water; if the kidney yin is insufficient, the yin cannot transform into yang. In addition, liver depression and qi stagnation, unfavorable qi transformation in the triple energizer, and urinary tract obstruction can all lead to abnormal bladder qi transformation. And dampness, heat, blood stasis, stagnation, and deficiency are the main pathological factors of stranguria. Generally speaking, the disease is stranguria in the early stage. If the course of the disease is long, the righteous qi is weak or the evil is strong, it can go from stranguria to retention. Clinically, there are many symptoms of mixed deficiency and excess.

[0036] Li Yongcui of the Qing Dynasty pointed out that the qi of the whole body is related to the lungs. When the lungs are clear, the qi flows. When the lungs are turbid, the qi is blocked. Therefore, urinary obstruction is mostly caused by the inability of lung qi to be released. It is advisable to mainly clear the metal and descend the qi, and treat it in conjunction with other symptoms. The lungs are the upper source of water. When heat is blocked in the lungs, the lung qi cannot descend, the distribution of body fluids is abnormal, the water channels are not regulated, and the body cannot be transported to the bladder, which will cause urinary obstruction. If the heat is too strong, the lung heat moves to the bladder, and the bladder is not functioning properly because the lungs cannot clear and purify, resulting in the upper and lower parts of the body being blocked by heat, and no urine can be passed. The disease is urgent and the symptoms are severe, which is worse than the previous one. The invention uses mulberry leaf, white mulberry bark and Chinese wolfberry bark to clear lung heat and nourish lung yin; platycodon, burdock fruit and schizonepeta to invigorate lung qi, lift the pot and open the lid, and they are all monarch drugs; cinnamon bark and aconite warm and nourish kidney yang and invigorate kidney qi, and they are all assistant drugs; bupleurum, cyperus rotundus and dried orange peel soothe the liver and regulate qi; plantain seed, desmodium scrotum and pyrrosia striata clear water channels, and they are all adjuvant drugs; gardenia, talcum powder, scutellaria baicalensis and phellodendron chinense clear damp-heat in the three burners, and they are all guiding drugs. Because the latent heat in the lung cannot produce water, or the lung is dry and cannot produce water, the whole prescription can relieve lung heat, invigorate lung qi, achieve the purpose of lung purging and descending, unblocking water channels, transporting to the bladder, and unblocking urination, so as to achieve the purpose of treating prostate hyperplasia. DETAILED DESCRIPTION

[0037] Embodiment 1:

[0038] Take 25g of mulberry leaves, 20g of white mulberry bark, 18g of Lycium bark, 25g of Platycodon grandiflorum, 15g of Burdock seeds, 25g of Nepeta tenuifolia, 10g of Cinnamon bark, 7g of Aconite root, 20g of Bupleurum root, 10g of Cyperus rotundus, 25g of Tangerine peel, 25g of Plantago seed, 20g of Lysimachia chinensis, 25g of Pyrrosia odoratus, 15g of Gardenia jasminoides, 10g of Talcum, 20g of Scutellaria baicalensis, and 15g of Phellodendron chinense. The preparation method is as follows:

[0039] (1) Extraction: Take talc and decoct for 1 hour, then add other raw materials, soak in water for 1 hour and decoct twice, each time for 1.5 hours. For the first decoction, add 10 times the amount of water of the medicinal materials, and for the second decoction, add 8 times the amount of water of the medicinal materials. The decoctions are filtered through a 100-mesh sieve and the two decoctions are combined;

[0040] (2) Concentration: taking the combined decoction from step (1), concentrating the decoction at a vacuum degree of -0.05 to -0.10 MPa and a temperature of 60 to 80° C., and controlling the relative density of the concentrated paste to be 1.10 to 1.20;

[0041] (3) Alcohol precipitation: Take the clear paste from step (2), add 95% ethanol, stir well to make the alcohol content of the solution reach 70%, and let it stand for 24 hours;

[0042] (4) recovering ethanol: taking the supernatant after standing in step (3), recovering ethanol and concentrating it to a clear paste having a relative density of 1.15 to 1.20 at 50° C.;

[0043] (5) Preparation of dry paste powder: Take the clear paste of step (4), spray dry it, grind it into dry paste powder, add starch and sodium carboxymethyl cellulose, use polyvinyl pyrrolidone to granulate, add sodium lauryl sulfate, and prepare granules.

[0044] Embodiment 2:

[0045] Take 20g of mulberry leaves, 25g of white mulberry bark, 15g of Lycium bark, 30g of Platycodon grandiflorum, 10g of burdock seeds, 30g of Nepeta tenuifolia, 8g of cinnamon bark, 8g of processed aconite root, 15g of bupleurum root, 15g of cyperus rotundus, 20g of dried tangerine peel, 30g of plantain seeds, 15g of Lysimachia chinensis, 30g of pyrrosia, 10g of gardenia, 12g of talc, 15g of scutellaria baicalensis, and 20g of phellodendron chinense. The preparation method is as follows:

[0046] (1) Extraction: Take talc and decoct for 1 hour, then add other raw materials, soak in water for 1 hour and decoct twice, each time for 1.5 hours. For the first decoction, add 10 times the amount of water of the medicinal materials, and for the second decoction, add 8 times the amount of water of the medicinal materials. The decoctions are filtered through a 100-mesh sieve and the two decoctions are combined;

[0047] (2) Concentration: taking the combined decoction from step (1), concentrating the decoction at a vacuum degree of -0.05 to -0.10 MPa and a temperature of 60 to 80° C., and controlling the relative density of the concentrated paste to be 1.10 to 1.20;

[0048] (3) Alcohol precipitation: Take the clear paste from step (2), add 95% ethanol, stir well to make the alcohol content of the solution reach 70%, and let it stand for 24 hours;

[0049] (4) recovering ethanol: taking the supernatant after standing in step (3), recovering ethanol and concentrating it to a clear paste having a relative density of 1.15 to 1.20 measured at 50° C.;

[0050] (5) Preparation of dry paste powder: Take the clear paste of step (4), spray dry, grind into dry paste powder, add microcrystalline cellulose, cross-linked polyvinyl pyrrolidone, use starch slurry for granulation, add magnesium stearate, and press into tablets.

[0051] Embodiment 3:

[0052] Take 30g of mulberry leaves, 15g of white mulberry bark, 20g of Lycium bark, 20g of Platycodon grandiflorum, 20g of Burdock seeds, 20g of Nepeta tenuifolia, 12g of cinnamon bark, 5g of processed aconite, 25g of bupleurum, 5g of Cyperus rotundus, 30g of dried tangerine peel, 20g of Plantago seeds, 25g of Lysimachia chinensis, 20g of Pyrrosia odoratus, 20g of Gardenia jasminoides, 8g of talc, 25g of Scutellaria baicalensis, and 10g of Phellodendron chinense. The preparation method is as follows:

[0053] (1) Extraction: Take talc and decoct for 1 hour, then add other raw materials, soak in water for 1 hour and decoct twice, each time for 1.5 hours. For the first decoction, add 10 times the amount of water of the medicinal materials, and for the second decoction, add 8 times the amount of water of the medicinal materials. The decoctions are filtered through a 100-mesh sieve and the two decoctions are combined;

[0054] (2) Concentration: taking the combined decoction from step (1), concentrating the decoction at a vacuum degree of -0.05 to -0.10 MPa and a temperature of 60 to 80° C., and controlling the relative density of the concentrated paste to be 1.10 to 1.20;

[0055] (3) Alcohol precipitation: Take the clear paste from step (2), add 95% ethanol, stir well to make the alcohol content of the solution reach 70%, and let it stand for 24 hours;

[0056] (4) recovering ethanol: taking the supernatant after standing in step (3), recovering ethanol and concentrating it to a clear paste having a relative density of 1.15 to 1.20 at 50° C.;

[0057] (5) Preparation of dry paste powder: Take the clear paste of step (4), spray dry, grind into dry paste powder, add chitosan, low-substituted hydroxypropyl cellulose, use hydroxypropyl methylcellulose for granulation, add magnesium stearate, and fill capsules.

[0058] Example 4: Effect of the present invention on experimental prostatic hyperplasia in mice

[0059] 80 male mice were randomly divided into a model group, a blank control group, a positive drug group [Qianliekang (Pulean tablets, approval number: National Medicine Standard Z33020303 manufacturer: Zhejiang Kangenbei Pharmaceutical Co., Ltd.) 0.57 g / kg group], and a 2.5 g / kg group of the granule product of Example 1 of the present invention. Except for the blank control group, the remaining mice were subcutaneously injected (Sc) with testosterone propionate (5 mg / kg) once a day, and then gavaged (ig) once 1 hour later. The blank group and the model group were given the same volume of distilled water for 30 consecutive days. On the 31st day, the mice were killed, and the prostate of each mouse was carefully peeled off and weighed (mg) respectively, and the prostate index (prostate weight (mg / 10g body weight) was calculated. The results are shown in Table 1.

[0060] Table 1 Effect of the present invention on experimental prostatic hyperplasia in mice (X±S)

[0061] Group Prostate weight (mg) Prostate index (mg / 10g) Blank group 14.35±3.19 5.04±0.45 Model Group <![CDATA[25.78±5.84 △△ ]]> <![CDATA[8.45±2.97 △△ ]]> Positive drug group 17.46±3.69** 5.94±2.13** Example 1 Group 16.74±4.13** 4.87±2.04**

[0062] Note: △△ indicates P < 0.01 compared with the blank control group, and ** indicates P < 0.01 compared with the model group.

[0063] As can be seen from Table 1, both the present invention and the positive drug group (Qianliekang group) can significantly inhibit experimental prostatic hyperplasia in mice, and the effect of Example 1 group is better than that of the positive drug group (Qianliekang group).

[0064] Example 5: Study on the effect of the present invention on ear swelling in mice

[0065] Take 26-30g male mice, randomly divided into three groups, each group of 10, namely, Example 2 group (20g / kg), positive drug Qianliekang group (2g / kg), physiological saline group (20ml / kg), gavage administration, once a day, for 3 consecutive days, 30min after the last administration, 0.05ml of 2% croton oil was applied to both sides of the left ear of the mouse, and the mouse was killed by dislocation 4h later, and the left and right ears were cut off. Then the round ear pieces were taken out at the same position with a puncher (diameter of 9mm), weighed with a torsion balance, and the weight of the ear shell was calculated. The results are shown in Table 2.

[0066] Table 2 Effect of the present invention on ear swelling of mice caused by croton oil (X±S)

[0067] Group quantity Ear swelling (mg) Normal saline group 10 11.9±4.2 Qianliekang Group 10 9.3±2.8* Example 2 Group 10 7.5±3.4*

[0068] *P<0.05 **P<0.01 compared with normal saline group

[0069] The experimental results showed that the Example 2 group of the present invention could reduce the ear swelling of mice caused by croton oil, and there was a significant difference compared with the normal saline group (P<0.05), indicating that the present invention has a significant anti-inflammatory effect, and the effect is better than the positive drug group (Qianliekang group).

[0070] Example 6: Clinical trial data of the present invention on lung heat and qi stagnation type prostatic hyperplasia

[0071] General information of experimental subjects: A total of 100 cases of prostatic hyperplasia of lung heat and qi stagnation type were treated with the Chinese medicine composition of the present invention, all of whom were patients of Yancheng Traditional Chinese Medicine Hospital, the oldest was 53 years old, the youngest was 28 years old, and all were male.

[0072] Diagnostic criteria: 1. Observe the size of the prostate through color Doppler ultrasound examination. If it is larger than 3cm, it can be diagnosed as prostate hyperplasia; if it reaches 4-5cm, it can be diagnosed as moderate or severe prostate hyperplasia; 2. Check the size of the prostate, whether there is hyperplasia on both sides of the prostate, and whether the central groove disappears through rectal examination to determine whether the prostate is hyperplastic; 3. Combine the level of prostate-specific antigen and the results of MRI scans to distinguish it from prostatitis and prostate cancer. The main manifestations of TCM diagnosis are urinary incontinence, dry throat, thirst, shortness of breath, or cough. The tongue coating is thin and yellow, and the pulse is rapid, which belongs to the type of prostate hyperplasia of lung heat and qi stagnation.

[0073] Efficacy criteria: Cured: The symptoms of dysuria disappear, and rectal examination or B-ultrasound indicates that the enlarged prostate returns to normal, and the TCM symptoms improve. Significantly effective: The symptoms of dysuria basically disappear, and the number of nocturia is halved or reduced to less than 2 times. Rectal examination or B-ultrasound examination shows that the enlarged prostate shrinks by one level, the residual urine is halved, or reduced to less than 30 ml, and the TCM symptoms improve. Improved: The dysuria is alleviated to varying degrees, and the number of nocturia is reduced by 2 times, but there is no obvious improvement in the prostate, and the TCM symptoms improve. Ineffective: There is no improvement in clinical symptoms and no improvement in objective examination indicators.

[0074] Treatment method: Usage and dosage: The granules prepared in Example 1 of the present invention are used in an amount of 2 packets each time, 10 grams per packet, 3 times a day, with warm water for administration. One week is one course of treatment, and a total of 4 courses of treatment are required. The results are shown in Table 3.

[0075] Table 3 Statistical results of the efficacy of each group

[0076] Efficacy get well Significant effect Improvement invalid Total Effectiveness 56 20 16 8 92％

[0077] In summary, the Chinese medicine composition of the present invention can relieve lung heat, open up lung qi, achieve the effect of lung descending, regulate water channels, transport to the bladder, and promote urination, thereby achieving the purpose of treating prostate hyperplasia. It has a significant effect on the treatment of prostate hyperplasia caused by lung heat and qi stagnation, and is easily accepted by patients.

[0078] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the appended claims of the application equally.

Claims

1. A Chinese medicine composition for treating prostatic hyperplasia, characterized in that: The invention is prepared by extracting the following Chinese medicinal raw materials: 20-30 parts of mulberry leaves, 15-25 parts of white mulberry barks, 15-20 parts of Chinese wolfberry barks, 20-30 parts of platycodon grandiflorum, 10-20 parts of burdock seeds, 20-30 parts of schizonepeta, 8-12 parts of cinnamon bark, 5-8 parts of processed aconite root, 15-25 parts of bupleurum root, 5-15 parts of cyperus rotundus, 20-30 parts of tangerine peel, 20-30 parts of plantain seeds, 15-25 parts of desmodium herb, 20-30 parts of pyrrosia, 10-20 parts of gardenia, 8-12 parts of talc, 15-25 parts of scutellaria baicalensis and 10-20 parts of phellodendron amurense.

2. A Chinese medicine composition for treating prostatic hyperplasia as claimed in claim 1, characterized in that: The invention is prepared by extracting the following Chinese medicinal raw materials: 25 parts of mulberry leaves, 20 parts of white mulberry barks, 18 parts of Chinese wolfberry barks, 25 parts of platycodon grandiflorum, 15 parts of burdock seeds, 25 parts of schizonepeta tenuifolia, 10 parts of cinnamon bark, 7 parts of processed aconite roots, 20 parts of bupleurum root, 10 parts of cyperus rotundus, 25 parts of tangerine peel, 25 parts of plantain seeds, 20 parts of desmodium herb, 25 parts of pyrrosia, 15 parts of gardenia, 10 parts of talc, 20 parts of scutellaria baicalensis, and 15 parts of phellodendron amurense.

3. A Chinese medicine composition for treating prostatic hyperplasia as claimed in claim 1, characterized in that: The invention is prepared by extracting the following Chinese medicinal raw materials: 20 parts of mulberry leaves, 25 parts of white mulberry barks, 15 parts of Chinese wolfberry barks, 30 parts of platycodon grandiflorum, 10 parts of burdock seeds, 30 parts of schizonepeta tenuifolia, 8 parts of cinnamon bark, 8 parts of processed aconite root, 15 parts of bupleurum root, 15 parts of cyperus rotundus, 20 parts of tangerine peel, 30 parts of plantain seeds, 15 parts of desmodium herb, 30 parts of pyrrosia, 10 parts of gardenia, 12 parts of talc, 15 parts of scutellaria baicalensis, and 20 parts of phellodendron amurense.

4. A Chinese medicine composition for treating prostatic hyperplasia as claimed in claim 1, characterized in that: The invention is prepared by extracting the following Chinese medicinal raw materials: 30 parts of mulberry leaves, 15 parts of white mulberry barks, 20 parts of Chinese wolfberry barks, 20 parts of platycodon grandiflorum, 20 parts of burdock seeds, 20 parts of schizonepeta tenuifolia, 12 parts of cinnamon bark, 5 parts of processed aconite roots, 25 parts of bupleurum root, 5 parts of cyperus rotundus, 30 parts of tangerine peel, 20 parts of plantain seeds, 25 parts of desmodium herb, 20 parts of pyrrosia, 20 parts of gardenia, 8 parts of talc, 25 parts of scutellaria baicalensis, and 10 parts of phellodendron amurense.

5. A Chinese medicine composition for treating prostatic hyperplasia as claimed in claim 1, characterized in that: The preparation method is: (1) Extraction: Take talc and decoct for 1 hour, then add other raw materials, soak in water for 1 hour and decoct twice, each time for 1.5 hours. For the first decoction, add 10 times the amount of water of the medicinal materials, and for the second decoction, add 8 times the amount of water of the medicinal materials. The decoctions are filtered through a 100-mesh sieve and the two decoctions are combined; (2) Concentration: taking the combined decoction from step (1), concentrating the decoction at a vacuum degree of -0.05 to -0.10 MPa and a temperature of 60 to 80° C., and controlling the relative density of the concentrated paste to be 1.10 to 1.20; (3) Alcohol precipitation: Take the clear paste from step (2), add 95% ethanol, stir well to make the alcohol content of the solution reach 70%, and let it stand for 24 hours; (4) recovering ethanol: taking the supernatant after standing in step (3), recovering ethanol and concentrating it to a clear paste having a relative density of 1.15 to 1.20 at 50° C.; (5) Preparation of dry paste powder: Take the clear paste from step (4), spray dry it, grind it into dry paste powder, add auxiliary materials, and prepare it into a solid preparation.

6. A Chinese medicine composition for treating prostatic hyperplasia as claimed in claim 5, characterized in that: The auxiliary materials in the preparation method are fillers, disintegrants, lubricants, and adhesives; the fillers are one or more of starch, pregelatinized starch, mannitol, chitin, microcrystalline cellulose, and sucrose; the disintegrants are one or more of starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl cellulose, cross-linked polyvinyl pyrrolidone, low-substituted hydroxypropyl cellulose, and cross-linked sodium carboxymethyl cellulose; the lubricants are one or more of magnesium stearate, sodium lauryl sulfate, talc, and silicon dioxide; and the adhesives are one or more of starch slurry, polyvinyl pyrrolidone, and hydroxypropyl methylcellulose.

7. A Chinese medicine composition for treating prostatic hyperplasia as claimed in claim 1, characterized in that: The prostatic hyperplasia is of the lung-heat and qi-stagnation type.