Traditional Chinese medicine composition for treating chronic prostatitis, traditional Chinese medicine preparation and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating chronic prostatitis, a traditional Chinese medicine preparation and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. In order to solve the problems of poor effect and large side effect of western medicines at present, the traditional Chinese medicine composition is prepared from 15g of sargentgloryvine stem, 15g of herba patriniae, 5g of rhizoma sparganii, 5g of curcuma zedoary, 15g of yam rhizome, 15g of dandelion, 15g of semen allii tuberosi, 15g of herba epimedii, 15g of oldenlandia diffusa, 15g of selfheal, 10g of tangerine seed, 5g of folium artemisiae argyi, 15g of dogwood, 15g of eucommia ulmoides, 10g of radix achyranthis bidentatae, 10g of codonopsis pilosula, 15g of poria cocos, 10g of rhizoma atractylodis macrocephalae, 5g of fennel, 10g of radix linderae and 10g of golden cypress. The prepared traditional Chinese medicine preparation is high in effective rate, good in compliance, free of dependence, small in side effect and beneficial to healing of chronic prostatitis patients.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition and a traditional Chinese medicine preparation for treating chronic prostatitis and a preparation method thereof. Background Art

[0002] Chronic prostatitis is a common and difficult-to-treat chronic disease that occurs in men of reproductive age between 20 and 50 years old, with a domestic incidence of 6.0% to 32.9%. The main symptoms are pain in the pelvic area, discomfort during urination, burning sensation in the urethra, and may be accompanied by sexual dysfunctions such as loss of libido, erectile dysfunction, premature ejaculation, and psychoneurological symptoms. The disease develops slowly, is stubborn, recurs repeatedly, and is difficult to cure, seriously affecting the quality of life and family harmony.

[0003] Traditional Chinese medicine does not have a disease name called chronic prostatitis, but based on its symptoms of testicular pain, frequent and urgent urination, burning and stinging pain in the urethra, dribbling after urination, white drops after urination, as well as pain and discomfort in the perineum, suprapubic area, and low back, it is classified into the categories of "turbid semen", "leucorrhea", "turbid stranguria" or "kidney deficiency and low back pain" in traditional Chinese medicine. The cause of this disease is complex. Traditional Chinese medicine believes that patients may be fond of eating greasy food, which leads to internal generation of dampness, or they may hold back their semen, or have unsatisfied sexual desire, or have unclean sexual intercourse, resulting in an empty seminal chamber, which causes the fire to move recklessly, consumes essence and damages yin, leading to poor circulation of qi and blood in the prostate and its adjacent tissues and organs, and blockage of meridians, which causes pain. The onset of many diseases is slow, and the initial treatment is poor, so the course of the disease gradually spreads. The initial pathological changes are mainly damp-heat, which then stagnates and transforms into qi, leading to meridian obstruction and damage to blood vessels. Long-term illness causes tuberculosis, and gradually symptoms of qi stagnation and blood stasis appear. Therefore, the treatment of chronic prostatitis focuses on regulating damp-heat and blood stasis, with the key points being clearing away heat, promoting dampness, and promoting blood circulation and removing blood stasis.

[0004] Most of the western medicines used to treat chronic prostatitis today can only alleviate symptoms to varying degrees, but cannot cure the disease. In addition, western medicines have serious side effects on the human body. Compared with western medicines, traditional Chinese medicine has stronger specificity and targeting in treating this disease. Therefore, developing drugs that can treat both the symptoms and the root cause from the perspective of traditional Chinese medicine has a good application prospect. Summary of the invention

[0005] In order to solve the deficiencies in the above background technology, the present invention proposes a Chinese medicine composition, a Chinese medicine preparation and a preparation method thereof for treating chronic prostatitis.

[0006] In order to achieve the above technical objectives, the present invention adopts the following technical solutions:

[0007] The technical solution of the first aspect provided by the present invention is: a traditional Chinese medicine composition for treating chronic prostatitis, comprising the following traditional Chinese medicine raw materials by weight: 10-30g of red vine, 10-30g of Patrinia scabra, 5-15g of Tripterygium wilfordii, 5-15g of Curcuma zedoaria, 10-30g of Dioscorea paniculata, 10-30g of Taraxacum mongolicum, 10-30g of Allium sativum seeds, 10-30g of Epimedium, 10-30g of Hedyotis diffusa, 10-30g of Prunella vulgaris, 10-30g of Citrus aurantium, 5-15g of Artemisia argyi, 10-30g of Cornus officinalis, 10-30g of Eucommia ulmoides, 10-30g of Achyranthes bidentata, 10-30g of Codonopsis pilosula, 10-30g of Poria, 10-30g of Atractylodes macrocephala, 5-15g of Cuscuta australis, 10-20g of Linderae strychnos acuminatum and 10-20g of Phellodendron chinense.

[0008] As a further preferred embodiment of the above technical scheme: 10-20g of red vine, 10-20g of Patrinia scabra, 5-10g of Tripterygium wilfordii, 5-10g of Curcuma zedoaria, 10-20g of Dioscorea paniculata, 10-20g of Taraxacum mongolicum, 15-20g of Allium sativum seed, 15-20g of Epimedium, 10-20g of Oldenlandia diffusa, 10-20g of Prunella vulgaris, 10-15g of Citrus aurantium, 5-10g of Artemisia argyi, 10-20g of Cornus officinalis, 10-20g of Eucommia ulmoides, 10-20g of Achyranthes bidentata, 10-20g of Codonopsis pilosula, 10-20g of Poria, 10-20g of Atractylodes macrocephala, 5-10g of fennel, 10-15g of Linderae scabra and 10-15g of Phellodendron chinense.

[0009] As a further preferred embodiment of the above technical scheme: 15g of red vine, 15g of Patrinia scabra, 5g of Tripterygium wilfordii, 5g of Curcuma zedoaria, 15g of Dioscorea paniculata, 15g of Taraxacum mongolicum, 15g of Allium sativum seed, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of fennel, 10g of Linderae scabra and 10g of Phellodendron chinense.

[0010] The following is an explanation and description of the drug mechanism of the Chinese medicine composition of the present invention:

[0011] Red twig: bitter, neutral. Enters the large intestine and liver meridians. Clears away heat and detoxifies, promotes blood circulation, dispels wind, and relieves pain. Used for abdominal pain caused by intestinal carbuncle, ulcers caused by heat toxins, injuries from falls, amenorrhea, dysmenorrhea, and rheumatic pain.

[0012] Patrinia scabra: pungent, bitter, slightly cold. Enters the stomach, large intestine, and liver meridians. Clears away heat and detoxifies, eliminates carbuncle and discharges pus, removes blood stasis and relieves pain. Used for intestinal carbuncle, lung carbuncle, carbuncle, sore, and abdominal pain caused by blood stasis after childbirth.

[0013] Trigonum multiflorum: pungent, bitter, neutral. Enters the liver and spleen meridians. Breaks blood and promotes qi circulation, eliminates stagnation and relieves pain. Used for accumulation of lumps, amenorrhea, heart and abdominal pain due to blood stasis, and abdominal distension and pain due to food stagnation.

[0014] Curcuma: pungent, bitter, warm. Enters the liver and spleen meridians. Breaks blood and promotes qi, eliminates stagnation and relieves pain. Used for stagnation and accumulation of masses, amenorrhea, heart and abdominal pain, food stagnation and abdominal distension and pain. Trillium and Curcuma are often used together.

[0015] Radix Dioscoreae: bitter, neutral. Enters the kidney and stomach meridians. Removes dampness and turbidity, dispels wind and removes numbness. Used for stranguria, leucorrhea, pain in the waist and knees, and difficulty in flexing and stretching tendons.

[0016] Taraxacum: bitter, sweet, cold. Enters the liver and stomach meridians. Clears away heat and detoxifies, reduces swelling and resolves stagnation, promotes dampness and relieves stranguria. Used for carbuncle, breast carbuncle, internal carbuncle, hot stranguria, damp-heat jaundice, red and swollen eyes due to liver heat.

[0017] Leek seeds: pungent, sweet, warm. Enter the kidney and liver meridians. Warm and nourish the liver and kidney, strengthen yang and consolidate essence. Used for impotence and spermatorrhea, leucorrhea, liver and kidney deficiency, soreness of waist and knees.

[0018] Epimedium: pungent, sweet, warm. Enters the kidney and liver meridians. Nourishes the kidney and strengthens yang, dispels wind and dampness. Used for kidney yang deficiency, impotence, frequent urination, weakness of waist and knees, wind-cold-dampness arthralgia, and numbness of limbs.

[0019] Hedyotis diffusa: slightly bitter, sweet, cold. Enters the stomach, large intestine, and small intestine meridians. Clears away heat and detoxifies, promotes dampness and relieves stranguria. Used for carbuncle, sore throat, snake bites, painful stranguria caused by heat, damp-heat jaundice, and various cancers.

[0020] Prunella Vulgaris: pungent, bitter, cold. Enters the liver and gallbladder meridians. Clears away heat and purges fire, improves eyesight, disperses stagnation and reduces swelling. Used for red and swollen eyes, headache and dizziness, night pain in the eyes, scrofula, goiter, and swelling and pain in breast abscess.

[0021] Tangerine seed: bitter, neutral. Enters the liver and kidney meridians. Regulates qi and resolves stagnation, relieves pain. Used for hernia pain, testicular swelling and pain, breast lumps, etc.

[0022] Artemisia argyi: pungent, bitter, warm. Slightly toxic. Enters the liver, spleen, and kidney meridians. Warms the meridians to stop bleeding, dispels cold and regulates menstruation, and stabilizes the fetus. Used for cold bleeding, cold in the lower jiao, irregular menstruation, dysmenorrhea, cold pain in the abdomen, and restless fetuses. It is also used to prevent the disadvantages of cold and blood stasis caused by taking a large number of cold and cool medicines.

[0023] Cornus officinalis: sour, astringent, slightly warm. Enters the liver and kidney meridians. Nourishes the liver and kidneys, astringes and consolidates. Used for soreness of waist and knees, dizziness and tinnitus, impotence, spermatorrhea, enuresis and frequent urination, metrorrhagia, menorrhagia, excessive sweating, physical weakness and thirst.

[0024] Eucommia: sweet, warm. Enters the liver and kidney meridians. Nourishes the liver and kidney, strengthens the tendons and bones, and stabilizes the fetus. Used for low back pain due to kidney deficiency, rheumatism, traumatic low back pain, menstrual low back pain, impotence due to kidney deficiency, cold and unstable semen, frequent urination, restless fetus, and habitual abortion.

[0025] Achyranthes bidentata: bitter, sweet, sour, neutral. Enters the liver and kidney meridians. Promotes blood circulation and menstruation, nourishes the liver and kidneys, strengthens tendons and bones, promotes diuresis and relieves stranguria, and guides fire (blood) downward. Used for blood stasis blocking amenorrhea, dysmenorrhea, abdominal pain during menstruation, retained placenta, traumatic injuries, soreness of waist and knees, paralysis of lower limbs, stranguria, edema, dysuria, headache, dizziness, toothache, oral ulcers, hematemesis, and epistaxis.

[0026] Codonopsis: sweet, neutral. Enters the spleen and lung meridians. Strengthens the spleen and lungs, nourishes blood and produces body fluids. Used for spleen and lung qi deficiency, poor appetite and fatigue, cough and asthma, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to loss of body fluids, internal heat and thirst, etc.

[0027] Poria: sweet, light, neutral. Enters the heart, spleen, and kidney meridians. Promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind. Used for various edemas caused by cold, heat, deficiency, and excess, spleen and stomach weakness, poor appetite, fatigue, phlegm and fluid retention, spleen deficiency and dampness diarrhea, palpitations, insomnia, etc.

[0028] Atractylodes macrocephala: bitter, sweet, warm. Enters the spleen and stomach meridians. Replenishes qi and strengthens the spleen, dries dampness and promotes diuresis, stops sweating, and stabilizes the fetus. Used for spleen and stomach qi deficiency, inability to transport and transform, poor appetite and loose stools, abdominal distension, limb weakness and fatigue, phlegm and fluid retention caused by spleen deficiency and water retention, edema, urinary difficulties, spleen deficiency and excessive sweating, and fetal movement disorders due to spleen deficiency.

[0029] Fennel: pungent, warm. Enters the liver, kidney, spleen, and stomach meridians. Dispels cold and relieves pain, regulates qi and harmonizes the stomach. Used for abdominal pain caused by cold hernia, testicular swelling and pain, cold pain in the lower abdomen, dysmenorrhea, and qi stagnation caused by deficiency of cold in the middle jiao.

[0030] Linderae Root: pungent, warm. Enters the lung, spleen, kidney, and bladder meridians. Promotes qi and relieves pain, warms the kidney and dispels cold. Used for chest and abdominal pain due to cold stagnation and qi stagnation, frequent urination, and enuresis.

[0031] Phellodendron chinense: bitter, cold. Enters kidney, bladder, and large intestine meridians. Clears away heat and dries dampness, purges fire and detoxifies, and relieves fever and removes steam. Used for damp-heat diarrhea, beriberi due to heat, diarrhea, jaundice, sores, swelling and pain, eczema, wet sores, yin deficiency fever, night sweats, and spermatorrhea.

[0032] The second technical solution provided by the present invention is: a traditional Chinese medicine preparation for treating chronic prostatitis.

[0033] Preferably, the Chinese medicine preparation is any one of pills, powders, granules, tablets, capsules, and extracts; more preferably, the Chinese medicine preparation is granules.

[0034] The third technical solution provided by the present invention is: a method for preparing a traditional Chinese medicine preparation for treating chronic prostatitis, wherein:

[0035] The preparation method of a Chinese medicine extract for treating chronic prostatitis comprises the following steps:

[0036] S1: weigh 15g of red vine, 15g of Patrinia scabra, 5g of Tripterygium wilfordii, 5g of Curcuma zedoaria, 15g of Radix Dioscoreae, 15g of Taraxaci, 15g of Allium sativum seeds, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of Fennel, 10g of Linderae umbellatae and 10g of Phellodendron amurense, mix well, add 10 times the amount of water and soak for 1-2h;

[0037] S2: After soaking, boil over high heat and then simmer over low heat for 2-3 hours, then filter;

[0038] S3: Add 8-10 times the amount of water again, boil, then simmer for 2 hours, filter;

[0039] S4: combining the medicinal solutions obtained by filtering twice in step S2 and step S3, concentrating to a thick paste with a relative density of 1.10 to 1.50, and drying to obtain an extract.

[0040] The preparation method of Chinese medicine granules for treating chronic prostatitis comprises the following steps:

[0041] S1: weigh 15g of red vine, 15g of Patrinia scabra, 5g of Tripterygium wilfordii, 5g of Curcuma zedoaria, 15g of Radix Dioscoreae, 15g of Taraxaci, 15g of Allium sativum seeds, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of Fennel, 10g of Linderae umbellatae and 10g of Phellodendron amurense, mix well, add 10 times the amount of water and soak for 1-2h;

[0042] S2: After soaking, boil over high heat and then simmer over low heat for 2-3 hours, then filter;

[0043] S3: Add 8-10 times the amount of water again, boil, then simmer for 2 hours, filter;

[0044] S4: combining the liquid medicines obtained by filtering twice in step S2 and step S3, concentrating to a thick paste with a relative density of 1.10 to 1.50, and drying to obtain an extract;

[0045] S5: Add pharmaceutical excipients to the extract in proportion and mix evenly, granulate by wet method, make granules after drying, and package.

[0046] The fourth technical solution provided by the present invention is: use of the Chinese medicine composition described in any one of the above aspects or the Chinese medicine preparation described in any one of the above aspects in the preparation of a drug for chronic prostatitis.

[0047] Compared with the prior art, the technical effects produced by the present invention are as follows:

[0048] 1. In the Chinese medicine composition of the present invention, Caulis Sargentodoxae, Herba Patriniae, and Herba Prunellae are the main ingredients of the liver meridian, and clearing away heat and toxic substances, removing blood stasis and relieving pain are the main ingredients; Radix Dipterocarpae, Herba Taraxaci, Herba Hedyotis Diffusae, and Herba Phellodendri are the ministers for clearing away heat and toxic substances, removing dampness and removing turbidity; Rhizoma Sparganii, Rhizoma Curcumae, Semen Allii Folium, Herba Epimedii, Semen Citri Reticulatae, Folium Artemisiae Argyi, Fennel, Fructus Corni, Eucommia, Codonopsis Pilosulae, Poria, and Rhizoma Atractylodis Macrocephalae are the adjuvants for warming the middle and invigorating the spleen, warming the liver and tonifying the kidney, and promoting blood circulation and relieving pain; Radix Achyranthis Bidentatae and Radix Linderae are the agents for promoting blood circulation and dispersing stagnation, and guiding the downward movement of the medicine. All the medicines cooperate with each other, complement each other, and treat both the symptoms and the root causes, and treat the root causes by warming the liver and invigorating the spleen, warming the yang and unblocking the collaterals, and treating the symptoms by clearing away heat and toxic substances, removing dampness and removing turbidity, and promoting blood circulation and dispersing stagnation, so as to achieve the treatment of testicular pain caused by chronic prostatitis, frequent and urgent urination, burning and stinging pain in the urethra, incomplete dripping after urine, white dripping after urine, and discomfort in the perineum, suprapubic area, and waist.

[0049] 2. The clinical efficacy of the Chinese medicine preparation prepared by the present invention can reach 90%, which is significantly better than the efficacy of existing Western medicines for chronic prostatitis. After treatment, the NIH-CPSI score, white blood cell count in EPS, quality of life and other indicators are significantly improved compared with those before treatment, indicating that the Chinese medicine preparation has a definite effect, and the Chinese medicine preparation has good compliance, no dependence, and small side effects. It can improve the patient's clinical symptoms and greatly reduce the mental and psychological burden of the patient's long-term medication with poor effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art are briefly introduced below.

[0051] Figure 1 It is an overall diagram of the Chinese medicine composition, preparation method and clinical effect evaluation of the present invention;

[0052] Figure 1 (a) confirming the components of the Chinese medicine composition of the present invention;

[0053] Figure 1 (b) is the theoretical basis of the present invention for treating chronic prostatitis by the "tongbu" method based on the theory of network disease;

[0054] Figure 1 (c) a method for preparing a standardized Chinese medicine preparation for treating chronic prostatitis according to the present invention;

[0055] Figure 2 A method for preparing the Chinese medicine extract for treating chronic prostatitis of the present invention;

[0056] Figure 3 A method for preparing the Chinese medicine granules for treating chronic prostatitis of the present invention;

[0057] Figure 4 Comprehensive evaluation of the effects of the Chinese medicine preparation of the present invention on clinical patients;

[0058] Figure 5 The electronic medical record of the clinical patient 1 of the present invention;

[0059] Figure 6 The test report sheet of the clinical patient 1 before treatment of the present invention;

[0060] Figure 7 The test report of the clinical patient 1 after treatment of the present invention;

[0061] Figure 8 The electronic medical record of clinical patient 2 of the present invention;

[0062] Fig. 9 The test report sheet of clinical patient 2 before treatment of the present invention;

[0063] Fig.10 The test report of clinical patient 2 after treatment of the present invention;

[0064] Fig.11 The electronic medical record of clinical patient 3 of the present invention;

[0065] Fig.12 The test report sheet of clinical patient 3 before treatment of the present invention;

[0066] Fig.13 The test report of clinical patient 3 after treatment of the present invention;

[0067] Fig.14 The electronic medical record of the clinical patient 4 of the present invention;

[0068] Fig.15 The test report sheet of the clinical patient 4 of the present invention before treatment;

[0069] Fig.16 The test report sheet of the clinical patient 4 of the present invention after treatment;

[0070] Fig.17 The electronic medical record of the clinical patient 5 of the present invention;

[0071] Fig.18 The test report sheet of the clinical patient 5 of the present invention before treatment;

[0072] Fig.19 This is the test report of clinical patient 5 after treatment of the present invention. DETAILED DESCRIPTION

[0073] To make the purpose, technical solution and advantages of the embodiments of the present invention more clear, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0074] Reference Figure 1-4 The present invention provides a traditional Chinese medicine composition for treating chronic prostatitis, comprising the following traditional Chinese medicine raw materials by weight: 10-30g of red vine, 10-30g of Patrinia scabra, 5-15g of Tripterygium wilfordii, 5-15g of Curcuma zedoaria, 10-30g of Radix Dipterocarpa, 10-30g of Taraxacum mongolicum, 10-30g of Allium sativum seeds, 10-30g of Epimedium, 10-30g of Hedyotis diffusa, 10-30g of Prunella vulgaris, 10-30g of Citrus aurantium, 5-15g of Artemisia argyi, 10-30g of Cornus officinalis, 10-30g of Eucommia ulmoides, 10-30g of Achyranthes bidentata, 10-30g of Codonopsis pilosula, 10-30g of Poria, 10-30g of Atractylodes macrocephala, 5-15g of Cuscuta australis, 10-20g of Linderae strychnos acuminatum and 10-20g of Phellodendron chinense.

[0075] Preferably: red vine 10-20g, Patrinia 10-20g, Tripterygium wilfordii 5-10g, Curcuma 5-10g, Dioscorea 10-20g, Taraxacum mongolicum 10-20g, Allium sativum seed 15-20g, Epimedium 15-20g, Oldenlandia diffusa 10-20g, Prunella vulgaris 10-20g, Citrus aurantium 10-15g, Artemisia argyi 5-10g, Cornus officinalis 10-20g, Eucommia ulmoides 10-20g, Achyranthes bidentata 10-20g, Codonopsis pilosula 10-20g, Poria 10-20g, Atractylodes macrocephala 10-15g, fennel 5-10g, Linderae 10-15g and Phellodendron chinense 10-15g.

[0076] More preferably: 15g of red vine, 15g of Patrinia scabra, 5g of Tripterygium wilfordii, 5g of Curcuma zedoaria, 15g of Dioscorea paniculata, 15g of Taraxacum mongolicum, 15g of Allium sativum seed, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of fennel, 10g of Linderae scabra and 10g of Phellodendron chinense.

[0077] The present invention also provides a method for preparing a Chinese medicine extract for treating chronic prostatitis, comprising the following steps:

[0078] S1: weigh 15g of red vine, 15g of Patrinia scabra, 5g of Tripterygium wilfordii, 5g of Curcuma zedoaria, 15g of Radix Dioscoreae, 15g of Taraxaci, 15g of Allium sativum seeds, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of Fennel, 10g of Linderae umbellatae and 10g of Phellodendron amurense, mix well, add 10 times the amount of water and soak for 1-2h;

[0079] S2: After soaking, boil over high heat and then simmer over low heat for 2-3 hours, then filter;

[0080] S3: Add 8-10 times the amount of water again, boil, then simmer for 2 hours, filter;

[0081] S4: Combine the two filtered solutions, concentrate to a thick paste with a relative density of 1.10 to 1.50, and dry to obtain an extract.

[0082] The present invention also provides a method for preparing a Chinese medicine granule for treating chronic prostatitis, comprising the following steps:

[0083] S1: weigh 15g of red vine, 15g of Patrinia scabra, 5g of Tripterygium wilfordii, 5g of Curcuma zedoaria, 15g of Radix Dioscoreae, 15g of Taraxaci, 15g of Allium sativum seeds, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of Fennel, 10g of Linderae umbellatae and 10g of Phellodendron amurense, mix well, add 10 times the amount of water and soak for 1-2h;

[0084] S2: After soaking, boil over high heat and then simmer over low heat for 2-3 hours, then filter;

[0085] S3: Add 8-10 times the amount of water again, boil, then simmer for 2 hours, filter;

[0086] S4: combining the two filtered solutions, concentrating to a thick paste with a relative density of 1.10 to 1.50, and vacuum drying the solution at a temperature of 80°C to obtain an extract, wherein the moisture content of the extract is controlled to be less than 5%;

[0087] S5: Add pharmaceutical excipients (including dextrin, microcrystalline cellulose, etc.) to the extract in proportion and mix evenly, use wet granulation, drying, filling to form granules, and pack into bags.

[0088] Embodiment 1:

[0089] Weigh 15g of red vine, 15g of Patrinia, 5g of Tripterygium, 5g of Curcuma, 15g of Dioscorea, 15g of Taraxacum, 15g of Allium, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella Vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of fennel, 10g of Linderae scutellariae and 10g of Phellodendron chinense respectively, and prepare granules according to the above method.

[0090] Embodiment 2:

[0091] Weigh 10g of red vine, 10g of Patrinia, 5g of Tripterygium, 5g of Curcuma, 10g of Dioscorea, 10g of Taraxacum, 10g of Allium, 10g of Epimedium, 10g of Hedyotis diffusa, 10g of Prunella Vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 10g of Cornus officinalis, 10g of Eucommia, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 10g of Poria, 10g of Atractylodes macrocephala, 5g of fennel, 10g of Linderae strychni and 10g of Phellodendron amurense, and prepare granules according to the above method.

[0092] Embodiment 3:

[0093] Weigh 30g of red vine, 30g of Patrinia, 15g of Tripterygium, 15g of Curcuma, 30g of Dioscorea, 30g of Taraxacum, 30g of Allium, 30g of Epimedium, 30g of Hedyotis diffusa, 30g of Prunella Vulgaris, 30g of Citrus aurantium, 15g of Artemisia argyi, 30g of Cornus officinalis, 30g of Eucommia, 30g of Achyranthes bidentata, 30g of Codonopsis pilosula, 30g of Poria, 30g of Atractylodes macrocephala, 15g of fennel, 20g of Linderae strychni and 20g of Phellodendron amurense, and prepare granules according to the above method.

[0094] Embodiment 4:

[0095] Weigh 20g of red vine, 20g of Patrinia, 10g of Tripterygium, 10g of Curcuma, 20g of Dioscorea, 20g of Taraxacum, 20g of Allium, 20g of Epimedium, 20g of Hedyotis diffusa, 20g of Prunella Vulgaris, 15g of Citrus aurantium, 10g of Artemisia argyi, 20g of Cornus officinalis, 20g of Eucommia, 20g of Achyranthes bidentata, 20g of Codonopsis pilosula, 20g of Poria, 15g of Atractylodes, 10g of Foeniculum vulgare, 15g of Linderae umbellatae and 15g of Phellodendron chinense respectively, and make granules according to the above method.

[0096] Embodiment 5:

[0097] Weigh 10g of red vine, 10g of Patrinia scabra, 10g of Tripterygium wilfordii, 10g of Curcuma zedoaria, 10g of Dioscorea paniculata, 10g of Taraxacum mongolicum, 15g of Allium sativum seed, 15g of Epimedium, 10g of Hedyotis diffusa, 10g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 10g of Cornus officinalis, 10g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 10g of Poria, 10g of Atractylodes macrocephala, 5g of fennel, 10g of Linderae scutellariae and 10g of Phellodendron chinense respectively, and make granules according to the above method.

[0098] Clinical application cases:

[0099] 1) General information:

[0100] 120 patients with chronic prostatitis who met the clinical diagnostic criteria were selected and divided into two groups according to the principle of non-random control. The treatment group had 60 cases, aged 23-55 years, with an average age of 36.32±8.87 years, a course of disease of 0.5-5 years, and an average course of disease of 2.48±1.33 years; the control group had 60 cases, aged 22-57 years, with an average age of 36.28±8.93 years, a course of disease of 0.5-4.8 years, and an average course of disease of 2.56±1.40 years. There was no significant difference in the general data between the two groups (P>0.05), and they were comparable.

[0101] 2) Diagnostic criteria and inclusion criteria:

[0102] Western medicine diagnosis refers to the 2014 edition of the "Guidelines for the Diagnosis and Treatment of Urological Diseases in China": (1) Clinical symptoms: patients have varying degrees of pelvic discomfort, abnormal urination, autonomic dysfunction and other changes, and are evaluated by the National Institutes of Health's Prostatitis Symptom Index (NIH-CPSI) score; (2) Laboratory examination: routine examination of prostatic fluid (EPS) under the microscope. If the EPS examination shows ≥10 white blood cells / HP, chronic prostatitis can be diagnosed; (3) Bacterial culture: The bacterial localization culture method for prostatitis is determined by urine culture before and after prostate massage (PPMT).

[0103] Inclusion criteria: (1) All patients met the above diagnostic criteria, and the prostatitis symptom score (NIH-CPSI) was ≥10 points. (2) Symptoms: The main manifestations were frequent urination, burning and stinging pain in the urethra, and dripping after urination. It may be accompanied by pain and discomfort in the testicles, perineum, and suprapubic area, white dripping after urination, wet scrotum, soreness of waist and knees, fatigue, dizziness, tinnitus, or (and) sexual dysfunction. (3) The white blood cell count of prostatic fluid was >10 / HP, the bacteriological culture was negative, and the lecithin bodies decreased or disappeared. (4) The patient gave informed consent and signed the informed consent form.

[0104] 3) Exclusion criteria:

[0105] (1) Patients who have used nonsteroidal anti-inflammatory drugs, receptor blockers, antibiotics and other drugs for the treatment of chronic prostatitis in the past week. (2) Patients with other cardiovascular and cerebrovascular diseases, prostatic hyperplasia, malignant tumors, neurogenic bladder, urethral stenosis, inguinal hernia, urinary tract stones, anorectal diseases, neurosis, liver and kidney diseases, blood system diseases, thyroid, adrenal or gonadal dysfunction. (3) Patients with poor compliance and neurological or mental illness. (4) Patients who have received other drug treatments and have a history of severe drug allergies. (5) Patients aged <20 or >60 years with a disease course of less than 3 months.

[0106] 4) Treatment methods:

[0107] The treatment group was given the Chinese medicine preparation prepared in Example 1 of the present invention for oral administration, with 6 packets of decoction-free granules for each dose, taken warm for 2 days, 3 times a day; the control group was given conventional treatment, 0.2 mg of tamsulosin hydrochloride sustained-release capsules [Astellas Pharmaceuticals (China) Co., Ltd., National Medicine Approval Number: Y0701] were taken orally, 1 capsule / night, and clarithromycin sustained-release tablets (Jiangsu Hengrui, National Medicine Approval Number 181220JK) were taken orally, 500 mg, 1 tablet / day. Both groups took it for 2 consecutive months.

[0108] 5) Observation indicators:

[0109] The improvements of NIH-CPSI symptom scores, main symptoms, white blood cell count in prostatic fluid (EPS) (median / HP), and quality of life (sexual dysfunction) were observed.

[0110] 6) Efficacy criteria:

[0111] NIH-CPSI was used to evaluate the severity of prostatitis, including pain and discomfort scores, as well as urination symptom scores. The evaluation was based on the sum of all the scores of the questions: mild 0-9 points, moderate 10-18 points, and severe 19-31 points. The evaluation was based on the scores of each question in the International Erectile Function Scale IIEF-5, which is a self-test of erectile dysfunction: mild 12-21 points, moderate 8-11 points, and severe 5-7 points. Cured: The patient's TCM clinical symptoms disappeared, sexual function returned to normal, NIH-CPSI score ≤ 9, IIEF-5 score ≥ 22, and EPS white blood cell count < 10 / HP; effective: The patient's TCM clinical symptoms were relieved or disappeared, the EPS white blood cell count decreased by 50% compared with the base number, and the score improved by one level; ineffective: The patient's TCM clinical symptoms did not show significant relief or worsened, the EPS white blood cell count did not change or changed slightly compared with the base number, and the score did not change. Total effective rate = cure rate + effective rate.

[0112] 7) Statistical methods:

[0113] All data were analyzed using SPSS 24.0 statistical software, and the improvement rates of count data were compared using the χ 2 The measurement data were expressed as ˉx±s, and the t-test was used for comparison among the groups. P<0.05 indicated that the difference was statistically significant.

[0114] 8) Statistical results:

[0115] ① Comparison of NIH-CPSI symptom scores between the two groups of prostatitis patients before and after treatment is shown in Table 1.

[0116] Table 1 Comparison of NIH-CPSI symptom scores between the two groups before and after treatment

[0117] Group Number of cases Before treatment After treatment Treatment Group 60 15.45±6.61 <![CDATA[2.20±1.43 *▲ ]]> Control group 60 15.15±6.09 9.15±4.15

[0118] Note: Compared with before treatment, *P<0.01; compared with the control group during the same period, ▲P<0.01.

[0119] As shown in Table 1, before treatment, there was no significant difference in the symptom scores of the NIH-CPSI method between the treatment group and the control group (P>0.05). After treatment, the pain and discomfort symptoms and urination symptoms of the patients in the treatment group were significantly relieved, and the scores were significantly lower than before treatment (P<0.01), and the treatment effect was significantly better than that of the control group (P<0.01).

[0120] ②Comparison of EPS leukocyte counts in the two groups of prostatitis patients before and after treatment is shown in Table 2.

[0121] Table 2 Comparison of EPS leukocyte counts between the two groups of patients before and after treatment

[0122] Group Number of cases Before treatment After treatment Treatment Group 60 29.00±9.95 <![CDATA[10.50±6.05 *▲ ]]> Control group 60 30.00±9.46 22.25±8.19

[0123] Note: Compared with before treatment, *P<0.01; compared with the control group during the same period, ▲P<0.01

[0124] As shown in Table 2, before treatment, there was no significant difference in the leukocyte count of EPS between the treatment group and the control group (P>0.05). After treatment, the leukocyte count of EPS in the treatment group was significantly lower than that before treatment (P<0.01), and was significantly lower than that in the control group during the same period, which was statistically significant (P<0.01).

[0125] ③Comparison of the quality of life scores of the two groups of prostatitis patients before and after treatment is shown in Table 3.

[0126] Table 3 Comparison of NIH-CPSI quality of life scores between the two groups

[0127] Group Number of cases Before treatment After treatment Treatment Group 60 7.00±2.87 <![CDATA[3.00±0.92 *▲ ]]> Control group 60 7.25±2.71 4.70±1.03

[0128] Note: Compared with before treatment, *P<0.01; compared with the control group during the same period, ▲P<0.01.

[0129] As shown in Table 3, before treatment, there was no significant difference in the scores of the treatment group and the control group on the impact of quality of life (P>0.05). After treatment, the impact of the treatment group on the quality of life of patients was significantly improved, and the score was significantly lower than before treatment (P<0.01), and significantly better than the control group (P<0.01).

[0130] ④Comparison of the self-assessed erectile function scores of the two groups of prostatitis patients before and after treatment is shown in Table 4.

[0131] Table 4 Comparison of erectile function scores between the two groups before and after treatment

[0132] Group Number of cases Before treatment After treatment Treatment Group 60 9.15±3.03 <![CDATA[19.50±4.37 *▲ ]]> Control group 60 9.00±2.68 9.85±3.70

[0133] Note: Compared with before treatment, *P<0.01; compared with the control group during the same period, ▲P<0.01.

[0134] As shown in Table 4, before treatment, there was no significant difference in the self-assessed erectile function scores between the treatment group and the control group (P>0.05). The erectile function scores of the treatment group were significantly improved compared with those before treatment (P<0.01), and the difference was statistically significant compared with the control group (P<0.01).

[0135] ⑤Comparison of the total effective rates of the two groups of prostatitis patients is shown in Table 3.

[0136] Table 5 Comparison of the total effective rate of treatment between the two groups of patients (%)

[0137]

[0138] Note: Compared with the control group, ★ P<0.01.

[0139] As shown in Table 5, after 2 months of treatment, 24 cases in the treatment group were cured, 30 cases were effective, and the total effective rate was 90%. In the control group, 5 cases were cured, 34 cases were effective, and the total effective rate was 65%. The total effective rate of the treatment group was significantly better than that of the control group.

[0140] The following are the detailed usage and effects of the Chinese medicine preparation prepared in Example 1 of the present invention on some patients in clinical treatment:

[0141] Reference Figure 5-7 Patient 1: Jing Moumou, male, 22 years old, chronic prostatitis for 1 year, testicular pain, urethral burning pain and discomfort, dripping after urination, scrotal moisture, accompanied by erectile dysfunction. Prostatic fluid examination showed: white blood cells> 40, a large number of amyloid bodies and a small number of granular cells appeared, diagnosed as chronic prostatitis, using the Chinese medicine composition of the present invention, when used, the Chinese medicine composition is prepared into decoction-free granules for oral administration, each dose is taken for 2 days, and taken 3 times a day. After 10 days of oral administration, the urethral burning pain was relieved, and the scrotal moisture was reduced. After taking it for 2 months, the urethral burning pain basically disappeared, the dripping after urination was significantly improved, and the erectile function was significantly enhanced. The reexamination of the prostatic fluid found that the white blood cells were <10, and granular cells were occasionally seen. The disease was basically cured.

[0142] Reference Figure 8-10Patient 2: Jiang, male, 39 years old, ankylosing spondylitis for 3 years, long-term use of anti-rheumatic immunosuppressants, chronic prostatitis for half a year, urethral burning pain discomfort, urinary incontinence, came to the clinic. Prostatic fluid examination showed: leukocytes 20-30, diagnosed as chronic prostatitis, using the Chinese medicine composition of the present invention, when used, the Chinese medicine composition is prepared into decoction-free granules for oral administration, each dose is taken for 2 days, and taken twice a day. After continuous oral administration of Chinese medicine for 20 days, the urethral burning pain was relieved, and the symptom of incontinence was also alleviated. After continuous use for 2 months, the prostatic fluid was re-examined and the leukocytes were <10, and the prostatitis was basically cured.

[0143] Reference Figure 11-13 Patient 3: Wu, male, 36 years old, chronic prostatitis for 3 years, perineum pain, scrotal moisture, waist pain, mild erectile dysfunction, prostate fluid examination showed: white blood cells> 40, diagnosed as chronic prostatitis, using the Chinese medicine composition of the present invention, when used, the Chinese medicine composition is prepared into decoction-free granules for oral administration, each dose is taken for 2 days, twice a day. After taking it for 1 month, the perineum pain is significantly improved, the scrotal moisture and waist pain are relieved, and the erectile function is basically restored after 2 months of use. The reexamination of prostate fluid found that the white blood cells were 20-30, and the disease has improved.

[0144] Reference Figure 14-16 Patient 4: Zhao, male, 28 years old, chronic prostatitis for 1 year, manifested as scrotal moisture, perineal discomfort, erectile dysfunction in the past year, which seriously affected his life. Prostatic fluid examination showed: white blood cells> 40, diagnosed as chronic prostatitis, using the Chinese medicine composition of the present invention, when using, the Chinese medicine composition is prepared into decoction-free granules for oral administration, each dose is taken for 2 days, 3 times a day. After the patient took it for 1 month, the scrotal moisture was reduced, the perineal discomfort was improved, and the erectile function was enhanced after 2 months of use. The reexamination of prostatic fluid found that the white blood cells were 10-20, and the prostatitis was basically cured.

[0145] Reference Figure 17-19 Patient 5: Zhang, male, 49 years old, chronic prostatitis for 8 months, frequent urination, urethral dripping, accompanied by scrotal moisture, erectile dysfunction, seriously affecting the family's sexual happiness, prostate fluid examination showed: white blood cells> 40, a small number of granular cells, diagnosed as chronic prostatitis, using the Chinese medicine composition of the present invention, when used, the Chinese medicine composition is prepared into decoction-free granules for oral administration, each dose is taken for 2 days, and taken twice a day. After the patient continued to take it for 20 days, the frequent urination improved, the scrotal moisture was reduced after 1 month, and the erectile function gradually improved. After continuous use for 2 months, the prostatitis was basically cured. The reexamination of the prostate fluid found that the white blood cells were 30-40, no granular cells were found, and the sexual function improved.

[0146] The Chinese medicine composition of the present invention can effectively treat common symptoms such as testicular pain, frequent and urgent urination, burning and stinging pain in the urethra, dripping after urination, white drops after urination, pain and discomfort in the perineum, suprapubic area, waist and the like caused by chronic prostatitis; compared with western medicines such as tamsulosin hydrochloride sustained-release capsules, clarithromycin sustained-release tablets, azithromycin and the like, the medicine of the present invention adopts traditional Chinese medicine for oral administration, and adopts decocting-free granules, which is convenient to use, has good compliance, is non-dependent, and basically does not affect liver and kidney functions, achieves the purpose of continuous and slow onset of effect, is conducive to the recovery of chronic diseases, and does not increase the mental and psychological burden of patients due to poor long-term medication effects.

[0147] The detailed description of the above embodiments is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the invention. The embodiments are only used to illustrate the technical solution of the invention and are not intended to limit it. Other modifications or equivalent substitutions made by ordinary technicians in the field to the technical solution of the invention should be included in the scope of the claims of the invention as long as they do not depart from the spirit and scope of the technical solution of the invention.

Claims

1. A Chinese medicine composition for treating chronic prostatitis, characterized in that: The invention comprises the following Chinese medicinal raw materials by weight: 10-30g of red vine, 10-30g of Patrinia scabra, 5-15g of Trigonosciadium japonicum, 5-15g of Curcuma zedoaria, 10-30g of Dioscorea macrocephala, 10-30g of Taraxacum mongolicum, 10-30g of Allium sativum seed, 10-30g of Epimedium, 10-30g of Hedyotis diffusa, 10-30g of Prunella vulgaris, 10-30g of Citrus aurantium, 5-15g of Artemisia argyi, 10-30g of Cornus officinalis, 10-30g of Eucommia ulmoides, 10-30g of Achyranthes bidentata, 10-30g of Codonopsis pilosula, 10-30g of Poria, 10-30g of Atractylodes macrocephala, 5-15g of Cuscuta australis, 10-20g of Linderae strychnos acuminatum and 10-20g of Phellodendron chinense.

2. A Chinese medicine composition for treating chronic prostatitis according to claim 1, characterized in that: The invention comprises the following Chinese medicinal raw materials by weight: 10-20g of red vine, 10-20g of Patrinia scabra, 5-10g of Trigonosciadium japonicum, 5-10g of Curcuma zedoaria, 10-20g of Dioscorea paniculata, 10-20g of Taraxacum mongolicum, 15-20g of Allium sativum seed, 15-20g of Epimedium, 10-20g of Oldenlandia diffusa, 10-20g of Prunella vulgaris, 10-15g of Citrus aurantium, 5-10g of Artemisia argyi, 10-20g of Cornus officinalis, 10-20g of Eucommia ulmoides, 10-20g of Achyranthes bidentata, 10-20g of Codonopsis pilosula, 10-20g of Poria, 10-15g of Atractylodes macrocephala, 5-10g of fennel, 10-15g of Linderae scabra and 10-15g of Phellodendron chinense.

3. A Chinese medicine composition for treating chronic prostatitis according to claim 1, characterized in that: The invention comprises the following Chinese medicinal raw materials by weight: 15g of red vine, 15g of Patrinia scabra, 5g of Tripterygium wilfordii, 5g of Curcuma zedoaria, 15g of Dioscorea paniculata, 15g of Taraxacum mongolicum, 15g of Allium sativum seed, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of fennel, 10g of Linderae scabra and 10g of Phellodendron chinense.

4. A Chinese medicine preparation for treating chronic prostatitis prepared from the Chinese medicine composition according to any one of claims 1 to 3.

5. A Chinese medicine preparation for treating chronic prostatitis according to claim 4, characterized in that: The traditional Chinese medicine preparation is any one of pills, powders, granules, tablets, capsules and extracts.

6. A method for preparing a Chinese medicine extract for treating chronic prostatitis, characterized in that: The following steps are involved: S1: weigh 15g of red vine, 15g of Patrinia scabra, 5g of Tripterygium wilfordii, 5g of Curcuma zedoaria, 15g of Radix Dioscoreae, 15g of Taraxaci, 15g of Allium sativum seeds, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of Fennel, 10g of Linderae umbellatae and 10g of Phellodendron amurense, mix well, add 10 times the amount of water and soak for 1-2h; S2: After soaking, boil over high heat and then simmer over low heat for 2-3 hours, then filter; S3: Add 8-10 times the amount of water again, boil, then simmer for 2 hours, filter; S4: Combine the medicinal solutions obtained by filtering twice in step S2 and step S3, concentrate to a thick paste with a relative density of 1.10 to 1.50, and obtain an extract after drying.

7. A method for preparing a Chinese medicine granule for treating chronic prostatitis, characterized in that: The following steps are involved: S1: weigh 15g of red vine, 15g of Patrinia scabra, 5g of Tripterygium wilfordii, 5g of Curcuma zedoaria, 15g of Radix Dioscoreae, 15g of Taraxaci, 15g of Allium sativum seeds, 15g of Epimedium, 15g of Hedyotis diffusa, 15g of Prunella vulgaris, 10g of Citrus aurantium, 5g of Artemisia argyi, 15g of Cornus officinalis, 15g of Eucommia ulmoides, 10g of Achyranthes bidentata, 10g of Codonopsis pilosula, 15g of Poria, 10g of Atractylodes macrocephala, 5g of Fennel, 10g of Linderae umbellatae and 10g of Phellodendron amurense, mix well, add 10 times the amount of water and soak for 1-2h; S2: After soaking, boil over high heat and then simmer over low heat for 2-3 hours, then filter; S3: Add 8-10 times the amount of water again, boil, then simmer for 2 hours, filter; S4: combining the liquid medicines obtained by filtering twice in step S2 and step S3, concentrating to a thick paste with a relative density of 1.10 to 1.50, and drying to obtain an extract; S5: Add pharmaceutical excipients to the extract in proportion and mix evenly, granulate by wet method, make granules after drying, and package.

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