Traditional Chinese medicine composition for chronic prostatitis accompanied by fatigue syndrome

Abstract

The invention relates to a traditional Chinese medicine composition for treating chronic prostatitis accompanied with fatigue syndrome, the traditional Chinese medicine composition is preferably prepared into dew or oral liquid, and the traditional Chinese medicine composition is prepared from rhizoma polygonati, mulberry, cistanche, raspberry, angelica sinensis, ginseng, schisandra chinensis, ramulus mori and folium mori, can significantly improve the pelvic pain symptom of a rat with prostatitis, and has no toxic or side effect. The leucocyte number and inflammatory factors of prostate are reduced, so that the symptoms and the life quality of chronic prostatitis accompanied by fatigue syndrome are obviously improved.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition for chronic prostatitis accompanied by fatigue syndrome. Background Art

[0002] The "Guidelines for the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Chronic Prostatitis" points out that chronic prostatitis (CP) refers to a disease in which patients present with symptoms such as pelvic pain or discomfort, abnormal urination, etc. under the action of pathogens and / or certain non-infectious factors. This disease belongs to the categories of "jingzhuo", "linzheng", "baizhuo", etc. in traditional Chinese medicine. There are many treatment methods for CP, and the research results of using a single treatment measure are often disappointing. The reason may be related to the fact that CP is a heterogeneous clinical syndrome with multiple etiologies, different progression pathways, diverse symptoms, and variable responses to treatment. Moreover, according to the integrated traditional Chinese and Western medicine collaborative classification idea based on UPOINT and "disease syndrome" in this guideline, in the phenotypic classification of "pelvic floor muscle tenderness", its clinical manifestations include: fibromyalgia, chronic fatigue syndrome, etc. In addition, Shi Zhengqi reported in "The Intervention Effect of Low-Energy Extracorporeal Shock Wave on the Expression of NGF / TRPV1 Signaling Pathway in Chronic Prostatitis Model Rats" that chronic prostatitis is also related to other functional somatic syndromes, such as irritable bowel syndrome, interstitial cystitis, chronic fatigue syndrome, and fibromyalgia, etc. Therefore, chronic fatigue syndrome will further trigger or exacerbate chronic prostatitis. Thus, chronic fatigue syndrome is not just a simple accompanying symptom, but rather mutually affects and further aggravates chronic prostatitis, resulting in poor efficacy of current treatment methods.

[0003] Li Gangqin et al. reported the clinical efficacy of Chaigui Granules in the treatment of type III prostatitis with water stasis syndrome. Chaigui Granules are based on Sini Powder and Danggui Shaoyao Powder as the basic formula, plus Corydalis yanhusuo and Litchi seed, and adopt the methods of promoting qi circulation, promoting diuresis, and activating blood circulation. Clinical studies have shown that Sini Powder can be used in the treatment of chronic prostatitis accompanied by liver depression, and Danggui Shaoyao Powder is a representative formula for nourishing blood and regulating the liver, strengthening the spleen and promoting diuresis, and is also used in the treatment of prostatitis.

[0004] CN101040977B discloses a pharmaceutical composition for treating prostate diseases, which contains extracts of Sabal serrulata and Echinacea as active ingredients. It can significantly reduce the dry and wet weight coefficients of the prostate in rats with chronic prostatitis models, and alleviate the infiltration of inflammatory cells and the hyperplasia of fibroblasts. CN114949108B discloses a traditional Chinese medicine composition for treating prostatitis, which contains the following raw materials and is prepared by extraction: Cortex Moutan, Rhizoma Alismatis, Rhizoma Anemarrhenae, Cortex Phellodendri, Radix Salviae Miltiorrhizae, Herba Lycopi, Radix Paeoniae Rubra, Semen Persicae, etc. It can nourish yin and clear heat, promote blood circulation to remove blood stasis, tonify the kidney and promote diuresis, clear heat and promote dampness, and promote qi movement to relieve stagnation, and has a good effect on prostatitis of yin deficiency and excessive fire type. CN113181122A discloses a traditional Chinese medicine compound Guihuang Fang granules for treating chronic prostatitis, including: weighing Angelica sinensis 6-12g, Cortex Phellodendri 3-12g, Flos Lonicerae 6-15g, Curcuma longa 3-10g, Olibanum 3-5g, Myrrha 3-5g, Radix Angelicae Dahuricae 3-10g, Plantago asiatica 9-30g, Hedyotis diffusa 9-30g, and Pericarpium Citri Reticulatae Viride 3-10g in proportion. It can significantly reduce the total NIH-CPSI score, pain, urination, and quality of life scores of patients with damp-heat stasis type CNP, improve the symptoms of patients, increase the activity of antioxidant enzymes, and inhibit the level of lipid peroxidation products in the prostate. CN107007785A discloses a traditional Chinese medicine composition for treating chronic prostatitis, which is mainly made of the following raw materials in parts by weight: Cuscuta chinensis 5-50 parts, Alpinia oxyphylla 5-50 parts, Schisandra chinensis 5-50 parts, Plantago asiatica 5-50 parts, Acorus tatarinowii 5-30 parts, Verbena officinalis 10-100 parts, Concha Ostreae 10-100 parts, Lindera aggregata 5-50 parts, Dioscorea septemloba 5-50 parts, Vaccaria segetalis 10-100 parts, Hirudo 5-30 parts, and it can significantly improve prostatitis. CN118512557A discloses a traditional Chinese medicine composition for treating chronic prostatitis by differentiating diseases. The composition includes Cinnamomum cassia, Epimedium brevicornu, Rehmannia glutinosa, Dioscorea opposita, Cornus officinalis, Dioscorea septemloba, Acorus tatarinowii, Alpinia oxyphylla, Lindera aggregata, Gardenia jasminoides, Achyranthes bidentata, Curcuma aromatica, and Litchi chinensis. The composition of the present invention has the effects of tonifying the kidney and assisting yang, promoting diuresis and resolving turbidity, soothing the liver and regulating qi, promoting blood circulation to relieve pain, etc., and can be used for the treatment of chronic prostatitis by differentiating diseases, and effectively relieve the four major clinical symptom groups involved in chronic prostatitis, such as pain symptoms, lower urinary tract symptoms, mental and psychological disorders, and sexual dysfunction. KR20230017389A discloses a composition for preventing or treating chronic prostatitis and lower urinary tract symptoms, which is composed of Trigonella foenum-graecum, Serenoa repens, arginine, Poria cocos, and fructooligosaccharide. The composition can prevent chronic prostatitis and the resulting lower urinary tract symptoms, and inhibit the increase in prostate size, thereby preventing urination problems and reducing the severity of fatigue, muscle weakness, and reduced motor ability in patients with male climacteric syndrome.Therefore, the current prevention and treatment of prostatitis focuses more on pain and urinary tract symptoms, while there are very few reports on prostatitis accompanied by fatigue syndrome. The scheme disclosed in KR20230017389A simply combines ingredients that reduce fatigue with raw materials for treating prostatitis. Its overall prevention and treatment effect is still limited, and there is a lack of targeted treatment plans. Summary of the invention

[0005] In view of the current deficiencies, the present invention provides a traditional Chinese medicine composition for chronic prostatitis accompanied by fatigue syndrome, which can significantly improve the pelvic pain symptoms of prostatitis rats, reduce the number of prostate white blood cells and inflammatory factors, and thus significantly improve the symptoms and quality of life of chronic prostatitis accompanied by fatigue syndrome.

[0006] First, the present invention provides a traditional Chinese medicine composition for chronic prostatitis accompanied by fatigue syndrome, which is prepared from the following traditional Chinese medicines in parts by weight: 10-60 parts of polygonatum, 10-60 parts of mulberry, 10-60 parts of cistanche, 5-30 parts of raspberry, 15-40 parts of angelica, 1-15 parts of ginseng, 3-20 parts of schisandra, 10-45 parts of mulberry branches, and 5-30 parts of mulberry leaves.

[0007] Huangjing is a perennial herbaceous plant of the Liliaceae family, also known as "chicken head ginseng" and "tiger ginger". It tastes sweet, is mild in nature, and is non-toxic; it enters the spleen, lung, and kidney meridians; it has the effects of nourishing the middle and replenishing qi, moistening the heart and lungs, and strengthening the tendons and bones. Huangjing was first recorded in "Famous Doctors' Records" and was listed as a top-grade product. Li Shizhen believed that "Huangjing receives the pure qi of Wu and Ji, so it is a good product for nourishing the Huang Palace. Earth is the mother of all things. If the mother is nourished by it, water and fire will be in harmony, wood and gold will be combined, and all evils will go away, and all diseases will not occur."

[0008] Mulberry is the fruit of the perennial woody plant mulberry tree, Moraceae, Moraceae. It tastes sweet, cool and sour, and enters the heart, liver and kidney meridians. It has the effects of nourishing the liver and kidneys, promoting fluid production and moistening the intestines, blackening hair and improving eyesight. It is used for vertigo and tinnitus, palpitations and insomnia, thirst due to loss of fluid, internal heat and thirst, and constipation due to blood deficiency.

[0009] Cistanche is the dried fleshy stem with scaly leaves of the plant Cistanche deserticola of the Orobanchaceae family. It is sweet, salty and warm in nature. It enters the kidney and large intestine meridians. It can replenish kidney yang, benefit essence and blood, moisten the intestines and promote bowel movements. It is used for impotence, infertility, soreness of the waist and knees, weakness of the tendons and bones, and dry intestines and constipation.

[0010] Raspberry is slightly cold in nature, sour and astringent in taste, and belongs to the liver and stomach meridians. It has the effect of nourishing the liver and kidneys. Pharmacology shows that it has an antioxidant effect, helps neutralize free radicals, slows down the aging process, and improves immunity. At the same time, raspberries are rich in dietary fiber, which helps promote intestinal peristalsis and relieve constipation.

[0011] Angelica sinensis tastes bitter, pungent, sweet, and warm in nature. It enters the liver, heart, and spleen meridians. It has the effects of nourishing blood, activating blood circulation, and regulating menstruation: it is usually used for symptoms such as dizziness, vertigo, and pale complexion caused by blood deficiency.

[0012] Schisandra chinensis tastes sour and sweet, and is warm in nature. It acts on the lung, heart, spleen, and kidney meridians. It has the effects of replenishing qi and nourishing yin, nourishing yin and moistening dryness, calming the mind and tranquilizing the spirit, and astringing and consolidating essence. For some symptoms caused by yin deficiency, such as dry mouth, dry throat, dizziness, etc., for symptoms such as anxiety, insomnia, and neurasthenia, and for treating spermatorrhea, impotence, etc. caused by kidney deficiency.

[0013] Mulberry twig: It is neutral in nature and bitter in taste. It acts on the liver meridian. It has the effects of dispelling wind-dampness, dredging collaterals, and promoting the flow of water qi.

[0014] Mulberry leaf: It is bitter, sweet, and cold in nature, and acts on the lung and liver meridians. It has the effects of dispersing wind-heat, moistening the lung and relieving dryness, and clearing the liver and improving eyesight.

[0015] The traditional Chinese medicine composition is preferably made from the following traditional Chinese medicines in parts by weight: 10 - 45 parts of polygonatum sibiricum, 10 - 50 parts of mulberry fruit, 10 - 45 parts of cistanche deserticola, 10 - 30 parts of raspberry, 15 - 30 parts of angelica sinensis, 3 - 15 parts of ginseng, 3 - 15 parts of schisandra chinensis, 10 - 35 parts of mulberry twig, 5 - 20 parts of mulberry leaf.

[0016] The traditional Chinese medicine composition is preferably made from the following traditional Chinese medicines in parts by weight: 10 - 30 parts of polygonatum sibiricum, 10 - 30 parts of mulberry fruit, 10 - 25 parts of cistanche deserticola, 10 - 25 parts of raspberry, 15 - 25 parts of angelica sinensis, 3 - 10 parts of ginseng, 6 - 15 parts of schisandra chinensis, 10 - 25 parts of mulberry twig, 9 - 20 parts of mulberry leaf.

[0017] The traditional Chinese medicine composition is preferably made from the following traditional Chinese medicines in parts by weight: 20 parts of polygonatum sibiricum, 40 parts of mulberry fruit, 20 parts of cistanche deserticola, 15 parts of raspberry, 25 parts of angelica sinensis, 6 parts of ginseng, 9 parts of schisandra chinensis, 15 parts of mulberry twig, 9 parts of mulberry leaf.

[0018] The present invention further provides a preparation, which comprises the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients. The preparation is selected from one of tablets, oral liquids, capsules, tinctures, granules.

[0019] Pharmaceutically acceptable excipients are selected from excipients, fillers, disintegrants, stabilizers, matrix carriers, sweeteners, binders, coating agents, swelling agents, lubricants, glidants, solvents, isotonic agents, or flavoring agents, etc.

[0020] The form of the pharmaceutical preparation can be capsules, granules, tablets, coated tablets, powders, suppositories, solutions, syrups, suspensions, emulsions, drops, or injections, etc. For example, for formulating into the form of tablets or capsules. Suitable fillers include but are not limited to starch, dextrin, microcrystalline cellulose, lactose, mannitol, etc., disintegrants include but are not limited to starch, methylcellulose, agar, bentonite, xanthan gum, etc., binders include but are not limited to starch, polyvinylpyrrolidone, hydroxypropylmethylcellulose, etc., and lubricants include but are not limited to sodium stearate, magnesium stearate.

[0021] When formulated into liquid preparations, a mixture of one or more solvents such as saline, sterile water, maltodextrin solution, glucose solution, buffered saline Ringer's solution, albumin injection solution, maltoglycerol, and ethanol can be used, and other conventional additives such as diluents, surfactants, dispersants, antioxidants, buffers, antibacterial agents, etc. can be further added.

[0022] The pharmaceutical preparation of the present invention can be administered orally or parenterally. In the case of parenterally administered, it can be administered by intravenous injection, subcutaneous injection, intramuscular injection, intraperitoneal injection, transdermal administration, etc., preferably oral administration.

[0023] The pharmaceutical preparation of the present invention can be formulated using pharmaceutically acceptable carriers and / or excipients according to methods that can be easily implemented by those skilled in the art, so as to be prepared in a unit volume form or loaded into a multi-volume container. In this case, the dosage form can be a solution, suspension or emulsion in an oil or aqueous medium, or can also be an extract, powder, granule, tablet or capsule form, preferably a capsule.

[0024] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, which comprises the following steps:

[0025] (1) Grinding ginseng into coarse powder;

[0026] (2) Extract polygonatum, mulberry, cistanche deserticola, raspberry, angelica, schisandra, mulberry branch, mulberry leaf and ginseng coarse powder with water or C1-C4 fatty alcohol solution, filter and collect the filtrate.

[0027] The C1-C4 fatty alcohol is selected from one or more of ethanol, propanol, and n-butanol, preferably a 50-90% ethanol solution, more preferably a 60%, 65%, 70%, or 80% ethanol solution.

[0028] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, which comprises the following steps:

[0029] (1) Grinding ginseng into coarse powder;

[0030] (2) Distill the raw materials of polygonatum, mulberry, cistanche deserticola, raspberry, angelica, schisandra, mulberry branch, mulberry leaf and ginseng powder with water to collect volatile oil.

[0031] The present invention also provides the use of the Chinese medicine composition in preparing a Chinese medicine product for improving chronic prostatitis accompanied by fatigue syndrome.

[0032] The chronic prostatitis is non-bacterial chronic prostatitis; more preferably, the chronic prostatitis is autoimmune non-bacterial chronic prostatitis.

[0033] Beneficial Effects

[0034] The traditional Chinese medicine composition of the present invention can be used to improve chronic prostatitis accompanied by fatigue syndrome, significantly improve the pelvic pain symptoms of rats with prostatitis, reduce the number of prostate white blood cells and inflammatory factors, and thus significantly improve the symptoms and quality of life of chronic prostatitis accompanied by fatigue syndrome. Specific embodiments

[0035] Example 1

[0036] Formulation: 20 g of polygonatum sibiricum, 40 g of mulberry, 20 g of cistanche deserticola, 15 g of rubus idaeus, 25 g of angelica sinensis, 6 g of ginseng, 9 g of schisandra chinensis, 15 g of mulberry twig, 9 g of mulberry leaf, a total of 9 traditional Chinese medicines. Among them, ginseng is pulverized into coarse powder, and then the ginseng coarse powder and other traditional Chinese medicines are added to 10 times the amount of water and soaked for 30 minutes, heated and boiled for extraction for 1 hour, filtered to obtain the filtrate, the medicinal residues are continued to be added to 12 times the amount of water and decocted for 1.5 hours, filtered to obtain the filtrate, and the filtrates are combined and concentrated.

[0037] Example 2

[0038] Formulation: 30 g of polygonatum sibiricum, 20 of mulberry, 30 g of cistanche deserticola, 10 g of rubus idaeus, 20 g of angelica sinensis, 3 g of ginseng, 6 g of schisandra chinensis, 25 g of mulberry twig, 10 g of mulberry leaf, a total of 9 traditional Chinese medicines. Among them, ginseng is pulverized into coarse powder, and then the ginseng coarse powder and other traditional Chinese medicines are added to 8 times the amount of 70% ethanol and refluxed for extraction for 1.5 hours, filtered to obtain the filtrate, the medicinal residues are continued to be added to 10 times the amount of 75% ethanol and refluxed for extraction for 1.5 hours, filtered to obtain the filtrate, and the filtrates are combined, the ethanol is recovered, concentrated and dried to make a powder.

[0039] Example 3

[0040] Formulation: 15 g of polygonatum sibiricum, 10 of mulberry, 10 g of cistanche deserticola, 30 g of rubus idaeus, 15 g of angelica sinensis, 9 g of ginseng, 9 g of schisandra chinensis, 30 g of mulberry twig, 15 g of mulberry leaf, a total of 9 traditional Chinese medicines. Among them, ginseng is pulverized into coarse powder, and then the ginseng coarse powder and other traditional Chinese medicines are added to 8 times the amount of 60% ethanol and refluxed for extraction for 2 hours, filtered to obtain the filtrate, the medicinal residues are continued to be added to 6 times the amount of 80% ethanol and refluxed for extraction for 1.5 hours, filtered to obtain the filtrate, the filtrates are combined, the ethanol is recovered, concentrated, dried, pulverized into powder, then starch, dextrin and binder are added for granulation and sieving, and then lubricant is added for tabletting.

[0041] Example 4

[0042] Formulation: 30 g of polygonatum sibiricum, 20 g of mulberry, 20 g of cistanche deserticola, 25 g of rubus idaeus, 30 g of angelica sinensis, 6 g of ginseng, 9 g of schisandra chinensis, 15 g of mulberry twig, 9 g of mulberry leaf, a total of 9 traditional Chinese medicines. Among them, ginseng is pulverized into coarse powder, and then the ginseng coarse powder and other traditional Chinese medicines are added to 10 times the amount of water and soaked for 30 minutes, heated and boiled for extraction for 3 hours, the volatile oil is collected and made into an aromatic water.

[0043] Example 5

[0044] Formulation: 20 g of Polygonatum sibiricum, 30 g of Mori fructus, 20 g of Cistanche deserticola, 25 g of Rubi fructus, 25 g of Angelicae sinensis radix, 6 g of Ginseng radix, 9 g of Schisandra chinensis fructus, 20 g of Mori ramulus, 9 g of Mori folium, a total of 9 traditional Chinese medicines. Among them, Ginseng radix was pulverized into coarse powder, and then the coarse powder of Ginseng radix, Polygonatum sibiricum, Mori fructus, Cistanche deserticola, Rubi fructus and Angelicae sinensis radix were added to 10 times the amount of water and soaked for 30 minutes, heated to boiling and extracted for 1 hour, filtered to obtain the filtrate, the medicinal residues were continued to be added with 12 times the amount of water and decocted for 1.5 hours, filtered to obtain the filtrate, the filtrates were combined, concentrated to a relative density of 1.05, taken out, cooled, ethanol was added to make the ethanol content reach 60%, left standing for 24 hours, filtered to obtain the ethanol solution; the remaining Schisandra chinensis fructus, Mori ramulus and Mori folium were added to 8 times the amount of 65% ethanol and reflux-extracted for 1 hour, filtered to obtain the filtrate, the medicinal residues were continued to be added with 6 times the amount of 70% ethanol and reflux-extracted for 1.5 hours, filtered to obtain the filtrate, the filtrates were combined with the above ethanol solution, the ethanol was recovered and concentrated, dried, pulverized into powder, an appropriate amount of dextrin was added and mixed evenly, made into pills with water, and dried to obtain the product.

[0045] Example 6

[0046] Formulation: 20 g of Polygonatum sibiricum, 30 g of Mori fructus, 20 g of Cistanche deserticola, 25 g of Rubi fructus, 25 g of Angelicae sinensis radix, 6 g of Ginseng radix, 9 g of Schisandra chinensis fructus, 20 g of Mori ramulus, 9 g of Mori folium, a total of 9 traditional Chinese medicines. Among them, Ginseng radix was pulverized into coarse powder, and then Polygonatum sibiricum, Mori fructus, Cistanche deserticola, Rubi fructus and Mori folium were added to 8 times the amount of water and soaked for 30 minutes, heated to boiling and extracted for 1.5 hours, filtered to obtain the filtrate, the medicinal residues were continued to be added with 12 times the amount of water and decocted for 1.5 hours, filtered to obtain the filtrate, the filtrates were combined, concentrated to a relative density of 1.15, taken out, cooled, ethanol was added to make the ethanol content reach 60%, left standing for 24 hours, filtered to obtain the ethanol solution; the coarse powder of Ginseng radix, Schisandra chinensis fructus, Angelicae sinensis radix and Mori ramulus were added to 8 times the amount of 70% ethanol and reflux-extracted for 1 hour, filtered to obtain the filtrate, the medicinal residues were continued to be added with 6 times the amount of 70% ethanol and reflux-extracted for 1.5 hours, filtered to obtain the filtrate, the filtrates were combined with the above ethanol solution, the ethanol was recovered and concentrated, dried, pulverized into powder, an appropriate amount of dextrin was added and mixed evenly, made into pills with water, and dried to obtain the product.

[0047] Example 7

[0048] Formulation: 40 g of Polygonatum sibiricum, 30 g of Morus alba fruit, 35 g of Cistanche deserticola, 20 g of Rubus chingii, 25 g of Angelica sinensis, 9 g of Panax ginseng, 12 g of Schisandra chinensis, 30 g of Ramulus mori, 6 g of Folium mori, a total of 9 traditional Chinese medicines. Among them, Panax ginseng is pulverized into coarse powder, then Polygonatum sibiricum, Morus alba fruit, Cistanche deserticola, Rubus chingii and Folium mori are added to 8 times the amount of water and soaked for 30 minutes, heated to boiling and extracted for 3 hours, the volatile oil is collected, and the above volatile oil is dissolved with an appropriate amount of glycerol; the coarse powder of Panax ginseng, Polygonatum sibiricum, Angelica sinensis and Ramulus mori are added to 10 times the amount of 70% ethanol and refluxed for 1 hour, filtered to obtain the filtrate, the medicinal residues are continued to be added to 8 times the amount of 75% ethanol and refluxed for 1.5 hours, filtered to obtain the filtrate, the filtrates and the above ethanol solution are combined, the ethanol is recovered and concentrated, diluted with distilled water, and then the above volatile oil glycerol solution is added, and mixed evenly to obtain the product.

[0049] Control Example 1

[0050] Formulation: 20 g of Polygonatum sibiricum, 40 g of Morus alba fruit, 20 g of Cistanche deserticola, 15 g of Rubus chingii, 25 g of Angelica sinensis, 6 g of Panax ginseng, 9 g of Schisandra chinensis, a total of 7 traditional Chinese medicines. Among them, Panax ginseng is pulverized into coarse powder, then the coarse powder of Panax ginseng and other traditional Chinese medicines are added to 10 times the amount of water and soaked for 30 minutes, heated to boiling and extracted for 1 hour, filtered to obtain the filtrate, the medicinal residues are continued to be added to 12 times the amount of water and decocted for 1.5 hours, filtered to obtain the filtrate, and the filtrates are combined and concentrated to obtain the product.

[0051] Control Example 2

[0052] Formulation: 20 g of Polygonatum sibiricum, 40 g of Morus alba fruit, 20 g of Cistanche deserticola, 15 g of Rubus chingii, 25 g of Angelica sinensis, 6 g of Panax ginseng, 9 g of Schisandra chinensis, 15 g of Ramulus cinnamomi, 9 g of Radix paeoniae alba, a total of 9 traditional Chinese medicines. Among them, Panax ginseng is pulverized into coarse powder, then the coarse powder of Panax ginseng and other traditional Chinese medicines are added to 10 times the amount of water and soaked for 30 minutes, heated to boiling and extracted for 1 hour, filtered to obtain the filtrate, the medicinal residues are continued to be added to 12 times the amount of water and decocted for 1.5 hours, filtered to obtain the filtrate, and the filtrates are combined and concentrated to obtain the product.

[0053] Control Example 3

[0054] Formulation: 20 g of Polygonatum sibiricum, 40 g of Morus alba fruit, 20 g of Cistanche deserticola, 15 g of Rubus chingii, 25 g of Angelica sinensis, 6 g of Panax ginseng, 9 g of Schisandra chinensis, 15 g of Ramulus cinnamomi, 9 g of Folium mori, a total of 9 traditional Chinese medicines. Among them, Panax ginseng is pulverized into coarse powder, then the coarse powder of Panax ginseng and other traditional Chinese medicines are added to 10 times the amount of water and soaked for 30 minutes, heated to boiling and extracted for 1 hour, filtered to obtain the filtrate, the medicinal residues are continued to be added to 12 times the amount of water and decocted for 1.5 hours, filtered to obtain the filtrate, and the filtrates are combined and concentrated to obtain the product.

[0055] Control Example 4

[0056] Prescription: 20 g of Polygonatum sibiricum, 40 g of Morus alba fruit, 20 g of Cistanche deserticola, 15 g of Rubus idaeus, 25 g of Angelica sinensis, 6 g of Panax ginseng, 9 g of Schisandra chinensis, and 9 g of Morus alba leaf, a total of 8 traditional Chinese medicines. Among them, Panax ginseng is pulverized into coarse powder, and then the coarse powder of Panax ginseng and other traditional Chinese medicines are added to 10 times the amount of water and soaked for 30 minutes, heated to boiling and extracted for 1 hour, filtered to obtain the filtrate, the medicinal residues are continued to be added to 12 times the amount of water and decocted for 1.5 hours, filtered to obtain the filtrate, and the filtrates are combined and concentrated to obtain.

[0057] Experimental Example

[0058] Construction of a Rat Model of Chronic Prostatitis with Fatigue Syndrome

[0059] Take male SD rats weighing 180 - 220 g. After anesthesia, on the 0th day and the 7th day respectively, 1.0 mL of a suspension of purified rat prostate protein and Freund's complete adjuvant (CFA) emulsion (a suspension with a ratio of 1:1) is subcutaneously injected at multiple points (0.3 mL × 2 in the upper part of both sides of the back, 0.2 mL in each of the bilateral inguinal regions); on the 21st day, the above-mentioned medicinal liquid is injected at multiple points once. Among them, the protein content of the purified rat prostate protein on the 0th and 7th days is 20 mg / mL, and the protein content of the purified rat prostate protein on the 21st day is 40 mg / mL. Usually, a rat model of autoimmune chronic non-bacterial prostatitis is formed 42 days after the first injection. In order to further prepare a rat model of chronic prostatitis with fatigue syndrome in the present invention, during the formation process after the 22nd day, the chronic multiple composite stress method is used to further combine fatigue syndrome in rats with chronic prostatitis. Specific method: Starting from the 22nd day, hang the rats for 1 h in the morning, increase by 0.5 h every 5 days, and continuously hang for 20 days; in the afternoon, swim to exhaustion under negative gravity in a pool with a water temperature of 20 - 22 °C and a water depth of 50 cm for 20 consecutive days. Thus, a rat model of autoimmune chronic non-bacterial chronic prostatitis with fatigue syndrome is formed.

[0060] Grouping: Normal control group, model group, Example 1 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group. Each group has 10 rats. The normal control group and the model group are intragastrically administered with normal saline, and the Example 1 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group are intragastrically administered with the corresponding drugs respectively for 21 consecutive days.

[0061] After the last administration, a VonFrey filament algometer is used to measure the mechanical pain threshold of rats in each group. After the last drug treatment, the rats are placed in a breeding cage and allowed to adapt for 30 min in a quiet environment, and then the pelvic area near the prostate is stimulated with a VonFrey filament for 10 consecutive times, 10 s each time (the interval between every 2 times exceeds 30 s), and the stimulation intensity gradually increases from 0.1 - 60.0 g. When the rats show behaviors such as hind leg jumping and severe abdominal contraction resistance, record the pain pressure value at this time.

[0062] Table 1 Mechanical pain thresholds of each group

[0063]

[0064]

[0065] The results show that Example 1 of the present invention can significantly improve the pain in the pelvic region of rats with chronic prostatitis, while Comparative Examples 1, 2, 3, and 4 have no obvious improvement in pain. Therefore, compared with the groups of Comparative Examples 1, 2, 3, and 4, Example 1 of the present invention has a significant difference in improving the pain in the pelvic region of rats with chronic prostatitis.

[0066] Determination of prostate index: After the last administration, the body weights (g) of the rats in each group were weighed and recorded. After detecting the pain threshold, the rats were sacrificed and the prostate tissues were collected. After cleaning and drying, the prostate mass (mg) was weighed, and the prostate index (prostate mass / body weight) was calculated.

[0067] Table 2 Prostate indices of each group

[0068]

[0069] The results show that both the group of Example 1 and the groups of Comparative Examples 1, 2, 3, and 4 can significantly improve the prostate index, and the effect of the group of Example 1 in improving the prostate index is slightly better than that of the groups of Comparative Examples 1, 2, 3, and 4.

[0070] Leukocyte count in prostatic fluid: After measuring the prostate index, the prostate was massaged, 10 μl of prostatic fluid was taken, and the leukocytes were counted under a microscope.

[0071] Table 3 Leukocyte numbers of each group

[0072]

[0073]

[0074] The results show that the traditional Chinese medicine composition of the present invention can significantly improve the leukocyte count in rats with autoimmune chronic non-bacterial prostatitis accompanied by fatigue syndrome.

[0075] Determination of cellular inflammatory factors in prostate tissue: The prostate tissue of rats was taken and added with physiological saline. After tissue homogenization and centrifugation, the supernatant was taken. According to the steps of the Elisa kit, the levels of cytokines TNF-α, IL-6, and MIP-1α in the prostate tissue were detected.

[0076] Table 4 Cellular inflammatory factors of each group

[0077]

[0078] The results showed that, compared with the control group, the levels of TNF-α, IL-6, and MIP-1α in the model group were significantly increased. Compared with the model group, the contents of inflammatory factors in each administration group decreased to varying degrees, but the effect of reducing the above-mentioned inflammatory factors in Example 1 group was significantly better than that in Comparative Example 1, 2, 3, and 4 groups.

[0079] At the same time, in the preliminary exploration experiment of the present invention, a rat model of autoimmune chronic non-bacterial prostatitis without fatigue syndrome was first established. The results showed that, compared with the autoimmune chronic non-bacterial prostatitis rats with fatigue syndrome, the pelvic pain symptoms of the autoimmune chronic non-bacterial prostatitis rats were relatively mild, and there were significant differences in pain symptoms; and the expression of MIP-1α inflammatory factor was also relatively low, with significant differences. At the same time, the effects of some indexes of Example 1 and Comparative Example 1 were also explored and compared. It was found that there was no obvious difference in the effects of Example 1 and Comparative Example 1 in relieving the pain of autoimmune chronic non-bacterial prostatitis rats and reducing the MIP-1α inflammatory factor, but in the autoimmune chronic non-bacterial prostatitis rats with fatigue syndrome, there were significant differences in improving the above symptoms between Example 1 and Comparative Example 1.

Claims

1. A Chinese medicine composition for chronic prostatitis accompanied by fatigue syndrome, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicines in parts by weight: 10-60 parts of polygonatum, 10-60 parts of mulberry, 10-60 parts of cistanche, 5-30 parts of raspberry, 15-40 parts of angelica, 1-15 parts of ginseng, 3-20 parts of schisandra, 10-45 parts of mulberry branches and 5-30 parts of mulberry leaves.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicines in parts by weight: 10-45 parts of polygonatum, 10-50 parts of mulberry, 10-45 parts of cistanche, 10-30 parts of raspberry, 15-30 parts of angelica, 3-15 parts of ginseng, 3-15 parts of schisandra, 10-35 parts of mulberry branches and 5-20 parts of mulberry leaves.

3. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicines in parts by weight: 10-30 parts of polygonatum, 10-30 parts of mulberry, 10-25 parts of cistanche, 10-25 parts of raspberry, 15-25 parts of angelica, 3-10 parts of ginseng, 6-15 parts of schisandra, 10-25 parts of mulberry branches and 9-20 parts of mulberry leaves.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following Chinese medicines in parts by weight: 20 parts of polygonatum, 40 parts of mulberry, 20 parts of cistanche, 15 parts of raspberry, 25 parts of angelica, 6 parts of ginseng, 9 parts of schisandra, 15 parts of mulberry branches, and 9 parts of mulberry leaves.

5. A Chinese medicine preparation for chronic prostatitis accompanied by fatigue syndrome, characterized in that: It comprises the Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients, and the preparation is selected from one of tablets, oral liquids, capsules, dew and granules.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: It includes the following steps: (1) Grinding ginseng into coarse powder; (2) Extract polygonatum, mulberry, cistanche deserticola, raspberry, angelica, schisandra, mulberry branch, mulberry leaf and ginseng coarse powder with water or C1-C4 fatty alcohol solution, filter and collect the filtrate.

7. The preparation method according to claim 6, characterized in that: The C1-C4 fatty alcohol is selected from one or more of ethanol, propanol and n-butanol.

8. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: It includes the following steps: (1) Grinding ginseng into coarse powder; (2) Distill the raw materials of polygonatum, mulberry, cistanche deserticola, raspberry, angelica, schisandra, mulberry branch, mulberry leaf and ginseng powder with water to collect volatile oil.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a Chinese medicine product for improving chronic prostatitis associated with fatigue syndrome.

10. The use according to claim 8, characterized in that: The chronic prostatitis is non-bacterial chronic prostatitis.

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