A traditional Chinese medicine composition for clearing heat and dampness, warming kidney and assisting yang, and a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for clearing heat and dampness, warming kidney and assisting yang as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The technical problem to be solved is to provide a traditional Chinese medicine composition which is safe and effective, has few side effects and can quickly relieve and treat chronic prostatitis. The technical solution is characterized by that the raw materials of the traditional Chinese medicine composition include cassia twig, white atractylodes, alisma orientalis, dried tangerine or orange peel, plantago seed, money grass, cornflower, pyrrosia lingii, imperata cylindrical root, golden cypress, radix morindae officinalis, herba epimedii, amomum villosum and poria cocos.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine. More specifically, the present invention relates to a traditional Chinese medicine composition with the effects of clearing heat and draining dampness, warming the kidney and assisting yang, as well as the preparation method and application thereof. Background Art

[0002] Chronic Prostatitis (CP) is one of the common diseases in the urology and andrology department. Epidemiological surveys have found that about half of men have experienced symptoms of prostatitis at a specific stage. Modern medicine considers CP as a heterogeneous clinical syndrome with multiple etiologies and multiple symptoms, and its pathogenesis is not yet clear. Pathogen infection, urine reflux, neuroendocrine factors and the like may be the main etiologies of CP. Chronic prostatitis falls into the categories of "stranguria with turbid discharge", "sperm turbidity", "hypogastric pain" and the like in traditional Chinese medicine. According to traditional Chinese medicine theories, "dampness, heat, stasis and stagnation" are the core pathogenesis causing chronic prostatitis, and common clinical syndrome differentiation types include damp-heat downward pouring syndrome, qi stagnation and blood stasis syndrome, liver qi constraint syndrome, kidney yin deficiency syndrome, kidney yang deficiency syndrome, and damp-heat stasis stagnation syndrome. The main manifestations are perineal distending pain, frequent urination, urgent urination, burning sensation during urination, which may be accompanied by systemic symptoms such as fever. Chronic prostatitis can be further divided into chronic bacterial prostatitis, chronic pelvic pain syndrome (inflammatory / non-inflammatory type) and asymptomatic prostatitis, among which chronic pelvic pain syndrome is more common. The lesions mainly occur in the prostate gland and surrounding tissues, manifested as chronic congestion of the gland, interstitial lymphocyte infiltration, dilated glandular ducts, and deposited secretions. Patients often experience pain and discomfort in the pelvic region, abnormal urination (such as waiting for urination, incomplete urination sensation), or are accompanied by sexual dysfunction.

[0003] Whether it is acute prostatitis or chronic prostatitis, Western medical treatment mainly focuses on antibacterial, anti-inflammatory and symptomatic drugs. For bacterial prostatitis, commonly used antibiotics such as levofloxacin, azithromycin and the like are used, α-receptor blockers (such as tamsulosin hydrochloride) can improve urination symptoms, and non-steroidal anti-inflammatory drugs (such as celecoxib) can relieve pain. The initial diagnosis symptoms may be improved, but long-term use is prone to drug resistance, and there are adverse reactions such as dizziness and gastrointestinal discomfort. Antibiotics have limited effects on non-bacterial prostatitis, and excessive use may also cause environmental drug resistance problems. In the field of traditional Chinese medicine, the treatment of prostatitis with traditional Chinese medicine follows the principle of syndrome differentiation and treatment, selects corresponding prescriptions according to the syndrome types, and the treatment methods are mainly clearing heat and draining dampness, removing stasis and relieving pain, soothing liver and relieving constraint, promoting diuresis and freeing strangury, nourishing yin and clearing heat, and the like. Traditional Chinese medicine therapies have shown unique advantages in dealing with chronic diseases, especially chronic non-bacterial prostatitis and physical conditioning. Treating diseases with traditional Chinese medicine has positive significance for replacing antibiotics and curbing drug resistance. Most traditional Chinese medicines are natural botanical drugs with relatively small toxic and side effects, which are suitable for long-term or repeated use.

[0004] The patent, published in China (CN105213888A) on January 6, 2016, discloses a dehumidifying, detoxifying, and weight-loss oral liquid made from Prunella vulgaris, comprising the following raw materials in parts by weight: 10-50 parts of Prunella vulgaris, 10-20 parts of Forsythia suspensa, 10-20 parts of Citrus medica, 10-20 parts of Benincasa hispida peel, 10-20 parts of Isatis indigotica root, 10-20 parts of Plantago asiatica seed, 10-20 parts of Citrus reticulata peel, 10-20 parts of Coix lacryma-jobi, 10-20 parts of Phragmites communis rhizome, 10-20 parts of Imperata cylindrica root, 10-20 parts of Trichosanthes kirilowii root, 10-20 parts of Bletilla striata, 10-20 parts of Atractylodes macrocephala, 10-20 parts of Scutellaria baicalensis, 10-20 parts of Alisma plantago-aquatica, 10-20 parts of Hedyotis diffusa, 10-20 parts of Epimedium brevicornu, 10-20 parts of Spatholobus suberectus, and 10-20 parts of Nelumbo nucifera leaf. This patent selects traditional Chinese medicines that clear heat and remove dampness. The formula can include ingredients that purge heat, detoxify, and clear away dampness. It promotes the elimination of dampness and heat by draining dampness from the lower body, based on the principle that dampness is excreted through urination and defecation.

[0005] This patent, published in China (CN118987151A) on August 17, 2024, discloses a traditional Chinese medicine formula for Buzhong Dihuang Decoction, its preparation method, and its application. Addressing the problem of spleen and kidney yang deficiency, which Western medicine currently cannot cure, the herbal formula includes Astragalus membranaceus, Codonopsis pilosula, stir-fried Atractylodes lancea, stir-fried Atractylodes macrocephala, prepared Glycyrrhiza uralensis, Angelica sinensis, Citrus reticulata peel, Cimicifuga foetida, Bupleurum chinense, Aconitum carmichaelii, Cinnamomum cassia, Citrus aurantium, Rehmannia glutinosa, Cornus officinalis, Dioscorea opposita, Paeonia suffruticosa, Alisma plantago-aquatica, Poria cocos, Psoralea corylifolia, Cuscuta chinensis, Lycium barbarum, Eucommia ulmoides, Cibotium barometz, Amomum villosum, roasted Hordeum vulgare, roasted Crataegus pinnatifida, roasted Massa fermentata, Cyperus rotundus, Curcuma zedoaria, Vaccaria segetalis, Agrimonia pilosa, Acorus tatarinowii, Zingiber officinale, and Ziziphus jujuba. The above-mentioned herbs are conventionally boiled in water to prepare a decoction, which can be adjusted according to the symptoms. Clinically, it can treat various diseases caused by spleen and kidney yang deficiency, with significant clinical efficacy.

[0006] The literature, "Clinical Observation on the Efficacy of Enema with Traditional Chinese Medicine Tongyu Lizhuo Decoction in the Treatment of Chronic Prostatitis / Chronic Pelvic Pain Syndrome and its Effect on the Levels of NE, IL-8, and TGF-β1 in EPS," records that the following herbs were used: Wangbuliuxing, Liujinu, Danshen, Baijiangcao, Huzhang, Tufuling, Zelan, Pugongying, Niuxi, and Ruxiang. The decoction was concentrated and bottled, and then stored at a constant temperature. Experimental results showed that this drug could effectively relieve the symptoms of patients with chronic prostatitis / chronic pelvic pain syndrome and regulate the levels of cytokines NE, IL-8, and TGF-β1 in EPS, making it an effective method for the clinical treatment of chronic prostatitis.

[0007] The prior art represented by the aforementioned literature has at least the following unresolved technical problems:

[0008] (1) The studies only focused on the effects of clearing heat and promoting diuresis, without directly targeting the treatment of chronic prostatitis. The relevant evidence is as follows: Publication No. CN105213888A, which verified the protective effect against acute liver injury, indicating its effect of promoting diuresis and resolving dampness; Publication No. CN118987151A, which verified the improvement of symptoms such as headache, palpitations, and night sweats through volunteer experiments, indicating its effect of warming the kidney and tonifying yang. None of the above studies directly targeted the treatment of chronic prostatitis.

[0009] (2) At present, there is still a lack of research on traditional Chinese medicine compositions that can clearly treat chronic prostatitis. Therefore, it is of great significance to find a safe, effective, low-side-effect, high-safety traditional Chinese medicine composition that can quickly relieve symptoms. Summary of the Invention

[0010] The purpose of this invention is to provide: A traditional Chinese medicine composition for clearing heat and dampness, warming the kidneys and tonifying yang, and related technologies, to solve technical problems such as safety, effectiveness, few side effects, and rapid relief and treatment of chronic prostatitis, or combinations thereof.

[0011] Terminology Explanation: Unless otherwise defined, all technical terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this subject matter pertains. Unless otherwise stated, all patents, patent inventions, and disclosures cited throughout this document are incorporated herein by reference in their entirety. Where multiple definitions exist for terms herein, the definitions provided in this chapter shall prevail.

[0012] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0013] The definitions of the standard terms can be found in the reference "Pharmacopoeia of the People's Republic of China (2020 Edition)".

[0014] Unless otherwise stated, conventional methods within the scope of the art, such as distillation, heating, vacuum recovery, decoction, filtration, and volume adjustment, shall be used.

[0015] Unless specifically defined herein, the use of all commercially available products herein employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0016] The term “therapeutic effective dose” as used in this article refers to a dose that is sufficient to achieve the desired therapeutic outcome or to affect undesirable symptoms, but is generally insufficient to cause adverse side effects.

[0017] The term “safe and effective amount” as used in this article refers to an amount sufficient to produce the desired effect but low enough to avoid serious side effects.

[0018] As used herein, the terms “subject” or “patient” may refer to a vertebrate organism, such as a mammal (e.g., a human). “Subject” may also refer to a cell, cell group, tissue, organ, or organism, preferably a human.

[0019] As used herein, the term "treatment" generally refers to achieving the desired pharmacological and / or physiological effect. An effect may be preventative, but not necessarily preventative, in relation to the prevention or partial prevention of a disease, symptom, or condition (such as dermatitis). An effect may be therapeutic in relation to the partial or complete cure of a disease, condition, symptom, or adverse reaction attributable to that disease, condition, or condition. Specifically, the term "treatment" can include any treatment of a subject (especially a person) for a relevant symptom or disease, and may include any one or more of the following: (a) prevention of the disease in subjects who may be susceptible to the disease but have not yet been diagnosed with it; (b) suppression of the disease, i.e., prevention of its development; and (c) relief of the disease, i.e., reduction or improvement of the disease and / or its symptoms or condition. The term "treatment" can refer to therapeutic treatment alone, preventative treatment alone, or both therapeutic and preventative treatment. A person requiring treatment (a subject requiring treatment) can include a person who already has a symptom and / or a person who needs to prevent a symptom.

[0020] The term "white grass root" as used in this article refers to the dried rhizome of the grass Imperata cylindrica Beauv. var. major (Nees) CE Hubb.

[0021] In a first aspect, the present invention provides a traditional Chinese medicine composition for clearing heat and dampness, warming the kidneys and assisting yang, wherein the raw materials of the traditional Chinese medicine composition include: cinnamon twig, atractylodes macrocephala, alisma plantago-aquatica, tangerine peel, plantain seed, lysimachia christinae, dianthus superbus, pyrrosia lingua, imperata cylindrica root, phellodendron bark, morinda officinalis, epimedium, amomum villosum and poria cocos.

[0022] This includes technical features such as specific types of raw materials.

[0023] As a preferred option, it also includes the technical feature of a specific weight percentage of the raw materials.

[0024] As an alternative implementation, the raw materials of the traditional Chinese medicine composition, by weight, include: Cinnamon twig 2-6 parts, Atractylodes macrocephala 1-5 parts, Alisma plantago-aquatica 1-5 parts, Citrus reticulata peel 1-5 parts, Plantago asiatica 4-8 parts, Lysimachia christinae 4-8 parts, Dianthus superbus 2-6 parts, Pyrrosia lingua 1-5 parts, Imperata cylindrica root 2-6 parts, Phellodendron chinense 1-5 parts, Morinda officinalis 2-6 parts, Epimedium brevicornu 2-6 parts, Amomum villosum 1-5 parts, and Poria cocos 1-5 parts.

[0025] As an alternative implementation, the raw materials of the traditional Chinese medicine composition, by weight, include: 3-5 parts of cinnamon twig, 2-4 parts of atractylodes macrocephala, 2-4 parts of alisma plantago-aquatica, 2-4 parts of tangerine peel, 4-8 parts of plantain seed, 4-8 parts of lysimachia christinae, 3-5 parts of dianthus superbus, 2-4 parts of pyrrosia lingua, 3-5 parts of imperata cylindrica root, 2-4 parts of phellodendron bark, 3-5 parts of morinda officinalis, 3-5 parts of epimedium, 2-4 parts of amomum villosum, and 2-4 parts of poria cocos.

[0026] As an alternative implementation, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 4 parts cinnamon twig, 3 parts atractylodes macrocephala, 3 parts alisma plantago-aquatica, 3 parts tangerine peel, 6 parts plantain seed, 6 parts lysimachia christinae, 4 parts dianthus superbus, 3 parts pyrrosia lingua, 4 parts imperata cylindrica root, 3 parts phellodendron chinense bark, 4 parts morinda officinalis, 4 parts epimedium, 3 parts amomum villosum, and 3 parts poria cocos.

[0027] The formula of the traditional Chinese medicine composition of the present invention is as follows: Cinnamon twig: pungent, sweet, and warm. It enters the heart, lung, and bladder meridians. It promotes sweating and relieves muscle tension, warms and unblocks the meridians, assists yang qi transformation, and calms and descends qi. It is used for wind-cold common cold, cold pain in the epigastrium and abdomen, amenorrhea due to blood stasis, joint pain, phlegm retention, edema, palpitations, and sudden abdominal pain.

[0028] Atractylodes macrocephala: Bitter, sweet, and warm. It enters the spleen and stomach meridians. It strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. It is used for spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0029] Alisma plantago-aquatica: Sweet, bland, and cold in nature. It enters the kidney and bladder meridians. It promotes urination and eliminates dampness, clears heat, resolves turbidity, and lowers lipids. It is used for dysuria, edema, diarrhea with scanty urine, phlegm retention and dizziness, painful urination due to heat, and hyperlipidemia.

[0030] Dried tangerine peel: bitter, pungent, and warm. 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, poor appetite, vomiting and diarrhea, and cough with excessive phlegm.

[0031] Plantain seed: Sweet, cold. Enters the liver, kidney, lung, and small intestine meridians. Clears heat, promotes urination, relieves strangury, eliminates dampness and stops diarrhea, improves eyesight, and resolves phlegm. Used for painful urination due to heat, edema and abdominal distension, summer-heat diarrhea, red and swollen eyes, and cough with phlegm and heat.

[0032] Lysimachia christinae: Sweet, salty, slightly cold. It enters the liver, gallbladder, kidney, and bladder meridians. It promotes diuresis and relieves jaundice, detoxifies and reduces swelling. It is used for damp-heat jaundice, gallbladder distension and hypochondriac pain, urinary stones, painful urination, carbuncles and boils, and snake and insect bites.

[0033] Dianthus superbus: Bitter, cold. Enters the Heart and Small Intestine meridians. Promotes urination and relieves strangury, invigorates blood and regulates menstruation. Used for urinary tract infections, hematuria, urinary stones, dysuria, painful urination, amenorrhea, and menstrual obstruction.

[0034] Pyrrosia lingua: Sweet, bitter, slightly cold. It enters the Lung and Bladder meridians. It promotes urination and relieves strangury, clears the lungs and stops cough, cools the blood and stops bleeding. It is used for strangury due to heat, hematuria, urinary stones, urinary retention, painful and difficult urination, cough with wheezing due to lung heat, hematemesis, epistaxis, hematuria, and metrorrhagia.

[0035] Imperata cylindrica root: sweet, cold. It enters the lung, stomach, and bladder meridians. It cools the blood and stops bleeding, clears heat and promotes diuresis. It is used for hematemesis due to blood heat, epistaxis, hematuria, feverish thirst, damp-heat jaundice, edema with scanty urine, and painful urination due to heat.

[0036] Phellodendron bark: Bitter, cold. Enters the kidney and bladder meridians. Clears heat and dries dampness, drains fire and eliminates steaming heat, detoxifies and heals sores. Used for damp-heat diarrhea, jaundice with dark urine, leukorrhea and vulvar itching, painful urination due to heat, beriberi with weakness and paralysis, steaming bone fever, night sweats, seminal emission, sores and carbuncles, eczema and damp sores. Salt-processed Phellodendron bark nourishes yin and reduces fire. Used for yin deficiency with excessive fire, night sweats and steaming bone fever.

[0037] Morinda officinalis: Sweet, pungent, slightly warm. Enters the kidney and liver meridians. Tonifies kidney yang, strengthens tendons and bones, dispels wind and dampness. Used for impotence, seminal emission, infertility due to cold uterus, irregular menstruation, lower abdominal pain due to cold, rheumatic pain, and weakness of tendons and bones.

[0038] Epimedium: pungent, sweet, and warm. It enters the liver and kidney meridians. It tonifies kidney yang, strengthens tendons and bones, and dispels wind and dampness. It is used for kidney yang deficiency, impotence, seminal emission, weakness of tendons and bones, rheumatic pain, numbness, and contractures.

[0039] Amomum villosum: pungent, warm. It enters the spleen, stomach, and kidney meridians. It resolves dampness and improves appetite, warms the spleen and stops diarrhea, regulates qi and calms the fetus. It is used for dampness obstructing the middle jiao, epigastric fullness and lack of appetite, spleen and stomach deficiency and cold, vomiting and diarrhea, morning sickness, and threatened abortion.

[0040] Poria cocos: Sweet, neutral. Enters the Heart and Spleen meridians. Calms the mind and soothes the nerves, promotes urination. Used for palpitations, forgetfulness, insomnia, epilepsy, and difficulty urinating.

[0041] Plantain seed, sweet, cold, and slippery, specifically clears damp-heat in the bladder, promotes urination, and eliminates turbidity through urine; Lysimachia christinae clears heat and dampness, and eliminates turbidity. These two herbs work synergistically to directly address the main symptoms of painful and difficult urination, and together they serve as the principal herbs. Morinda officinalis invigorates yang and benefits essence, while Epimedium tonifies the kidneys and strengthens tendons, assisting the transformation of qi at the gate of life to restore the bladder's function of steaming and purging, thus treating frequent urination and lower back coldness from the root cause; Dianthus superbus, Pyrrosia lingua, Phellodendron amurense, and Alisma plantago-aquatica assist the principal herbs in clearing and promoting urination as assistant herbs: Dianthus superbus breaks up blood stasis and promotes urination, Pyrrosia lingua clears the lungs and opens the orifices (opening the upper source of water), Phellodendron amurense drains the ministerial fire in the lower jiao, and Alisma plantago-aquatica drains dampness and clears heat. These six herbs together serve as assistant herbs, working in conjunction with the principal herbs to dredge the water passages and resolve stagnation and heat. Cinnamon twig is added to warm and invigorate kidney yang, while also preventing cold and dampness from taking hold. Atractylodes macrocephala is added to strengthen the spleen, dry dampness, and eliminate the source of turbidity. Tangerine peel is added to regulate qi, transform stagnation, and restore the central jiao's function. Amomum villosum is added to invigorate the spleen and protect the stomach, preventing the bitter and cold herbs from harming the middle jiao. Imperata cylindrica root is added to promote urination and generate fluids, mitigating the harm of excessive urination to yin. Poria cocos is added to drain dampness, calm the mind, and soothe the spirit of long-term illness and stagnation. Cinnamon twig also serves as the guiding herb, its pungent and warm properties guiding the other herbs directly to the bladder and seminal vesicles, opening the gates of urination. The herbs work synergistically, clearing heat without harming yang, warming without generating heat, eliminating pathogens while supporting the body's vital energy. When damp heat is eliminated, the water passages become clear; when kidney yang is replenished, qi transformation is restored, and urinary tract infections naturally heal.

[0042] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the first aspect of the present invention includes: As a preferred embodiment, the raw materials of the traditional Chinese medicine composition include: 2-6 parts of cinnamon twig, 1-5 parts of atractylodes macrocephala, 1-5 parts of alisma plantago-aquatica, 1-5 parts of tangerine peel, 4-8 parts of plantain seed, 4-8 parts of lysimachia christinae, 2-6 parts of dianthus superbus, 1-5 parts of pyrrosia lingua, 2-6 parts of imperata cylindrica root, 1-5 parts of phellodendron bark, 2-6 parts of morinda officinalis, 2-6 parts of epimedium, 1-5 parts of amomum villosum, and 1-5 parts of poria cocos; more preferably: 3-5 parts of cinnamon twig, 2-4 parts of atractylodes macrocephala, 2-4 parts of alisma plantago-aquatica, and 2-4 parts of tangerine peel. The preferred formulation consists of: 4-8 parts Plantago asiatica, 4-8 parts Lysimachia christinae, 3-5 parts Dianthus superbus, 2-4 parts Pyrrosia lingua, 3-5 parts Imperata cylindrica, 2-4 parts Phellodendron chinense, 3-5 parts Morinda officinalis, 3-5 parts Epimedium brevicornu, 2-4 parts Amomum villosum, and 2-4 parts Poria cocos. A further optimized formulation includes: 4 parts Cinnamomum cassia, 3 parts Atractylodes macrocephala, 3 parts Alisma plantago-aquatica, 3 parts Citrus reticulata peel, 6 parts Plantago asiatica, 6 parts Lysimachia christinae, 4 parts Dianthus superbus, 3 parts Pyrrosia lingua, 4 parts Imperata cylindrica, 3 parts Phellodendron chinense, 4 parts Morinda officinalis, 4 parts Epimedium brevicornu, 4 parts Amomum villosum, and 3 parts Poria cocos. This optimized formulation, while addressing the technical issue of "improving the synergistic effect between components and significantly enhancing the treatment of chronic prostatitis," further strengthens the efficacy of the same technical approach.

[0043] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the step of mixing cinnamon twig, tangerine peel, amomum villosum, atractylodes macrocephala, alisma plantago-aquatica, plantain seed, lysimachia christinae, dianthus superbus, pyrrosia lingua, imperata cylindrica root, phellodendron bark, morinda officinalis, epimedium, and poria cocos.

[0044] Furthermore, it also includes sterilization and / or pulverization steps.

[0045] As an alternative implementation, the method for preparing the traditional Chinese medicine composition includes the following steps: S1. Sterilize the following ingredients by moist heat at 90-120℃ for 10-60 minutes and then dry them at 40-80℃: Cinnamon twig, dried tangerine peel, Amomum villosum, Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica root, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos. S2. The sterilized and dried traditional Chinese medicine composition from step S1 is pulverized into a fine powder, sieved, and mixed to obtain the traditional Chinese medicine composition.

[0046] As an alternative implementation, the method for preparing the traditional Chinese medicine composition includes the following steps: S1. Cinnamon twig, dried tangerine peel, amomum villosum, atractylodes macrocephala, alisma plantago-aquatica, plantain seed, lysimachia christinae, dianthus superbus, pyrrosia lingua, imperata cylindrica root, phellodendron bark, morinda officinalis, epimedium, and poria cocos: sterilized by moist heat at 105℃ for 30 minutes and dried at 60℃. S2. Weigh the sterilized and dried traditional Chinese medicine composition from S1 above, pulverize it into a fine powder, pass it through a 100-mesh sieve, and mix it at 10 rpm for 30 minutes to obtain the traditional Chinese medicine composition.

[0047] Thirdly, the present invention provides a processing method for the above-mentioned traditional Chinese medicine composition, comprising a combination of distillation extraction and solvent extraction steps, to prepare a traditional Chinese medicine extract.

[0048] This includes technical features: a specific extraction method.

[0049] Furthermore, the solvent extraction is selected from water extraction and / or alcohol extraction.

[0050] Furthermore, the water extraction is performed by boiling water to extract the water.

[0051] Furthermore, the alcohol extraction is performed by reflux extraction with ethanol. Furthermore, the volume fraction of the ethanol is 60-80%.

[0052] As an alternative implementation, the processing method of the above-mentioned traditional Chinese medicine composition includes the following steps: Cinnamon twig, dried tangerine peel, and amomum villosum were extracted by distillation. Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos were extracted by decoction with water. The extracts were combined to obtain the Chinese herbal extract.

[0053] As an alternative implementation, the processing method of the above-mentioned traditional Chinese medicine composition includes the following steps: S1. Cinnamon twig, dried tangerine peel, and amomum villosum were distilled to extract volatile oil; the distilled residue was boiled with water to extract the oil, and the decoction was filtered to obtain filtrate 1. S2. Extract the following herbs with solvent: Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos. Filter the mixture to obtain filtrate 2. S3. Combine filtrate 1 obtained in step S1 and filtrate 2 obtained in step S2, and add the volatile oil obtained in step S1 to obtain the traditional Chinese medicine extract.

[0054] As an alternative implementation, in step S1, the distillation extraction is performed by adding 6-10 times the total mass of the raw materials to water, and distilling 1-3 times, with each extraction lasting 1-4 hours.

[0055] As an alternative implementation, in step S1, the number of times water is added and boiled is 1-4 times.

[0056] As a further alternative implementation, in step S1, the water-adding decoction extraction is performed by adding 6-10 times the total mass of the raw materials to water, and decocting and extracting 1-2 times, each time for 1-4 hours.

[0057] As an alternative implementation, in step S2, the solvent extraction is performed by: boiling with water and / or reflux extraction with ethanol.

[0058] When the solvent extraction is performed by boiling with water or reflux extraction with ethanol, as an optional implementation scheme, the boiling with water extraction is performed by adding 6-12 times the total mass of the raw material and boiling for 1-3 times, each time for 1-4 hours; the reflux extraction with ethanol is performed by adding 4-10 times the total mass of the raw material and heating and refluxing for 1-3 times, each time for 0.5-3 hours.

[0059] As an alternative implementation, the extraction by boiling with water further includes an alcohol precipitation step. This is further refined by: concentrating the solution, adding ethanol to the concentrate and stirring, allowing it to stand for 12-36 hours, and then filtering to recover the ethanol.

[0060] When the solvent extraction is performed by decoction with water and reflux extraction with ethanol, as an optional implementation, step S2 is as follows: Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Imperata cylindrica, Morinda officinalis, and Poria cocos are extracted by decoction with water, and Epimedium brevicornu, Phellodendron chinense, Lysimachia christinae, Pyrrosia lingua, and Dianthus superbus are extracted by reflux extraction with ethanol.

[0061] Further, the water decoction extraction is performed by adding 6-12 times the total mass of the raw materials and decocting for 1-3 times, each time for 1-4 hours; the ethanol reflux extraction is performed by adding 4-10 times the total mass of the raw materials and heating and refluxing for 1-3 times, each time for 0.5-3 hours.

[0062] As an alternative implementation, the extraction by boiling with water further includes an alcohol precipitation step. This is further refined by: concentrating the solution, adding ethanol to the concentrate and stirring, allowing it to stand for 12-36 hours, and then filtering to recover the ethanol.

[0063] As an alternative implementation, step S3 may include a concentration and drying step after combining the filtrate 1 obtained in step S1 and the filtrate 2 obtained in step S2, or after adding the volatile oil obtained in step S1.

[0064] The concentration can be selected from common concentration methods in the art, including but not limited to one or more combinations of atmospheric pressure evaporation, vacuum concentration, thin film evaporation, freeze concentration, and reverse osmosis concentration.

[0065] The drying process can be selected from common drying methods in the art, including but not limited to one or more combinations of drying methods such as baking, freeze drying, spray drying, vacuum drying, and so on.

[0066] As an alternative implementation, the processing method of the above-mentioned traditional Chinese medicine composition includes the following steps: S1. Weigh out the cinnamon twig, tangerine peel, and amomum villosum from the above-mentioned Chinese herbal composition, add 8 times the amount of water and distill for 4 hours to obtain volatile oil; add 8 times the amount of water to the distilled residue and decoct for 1 hour, filter the decoction to obtain filtrate 1; S2. Weigh out the remaining Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos from the above-mentioned Chinese herbal medicine composition, add 8 times the amount of water, decoct twice, 1.5 hours each time, filter the decoction to obtain filtrate 2. S3. Combine the filtrate 1 obtained in step S1 and the filtrate 2 obtained in step S2, concentrate under reduced pressure to a thick paste, dry under vacuum at 70°C, pulverize, add the volatile oil obtained in step S1 and mix well to obtain the traditional Chinese medicine extract.

[0067] As an alternative implementation, in step S3, the drying is performed under reduced pressure at 60-80°C (preferably 70°C).

[0068] As an alternative implementation, the processing method of the above-mentioned traditional Chinese medicine composition includes the following steps: S1. Weigh out the cinnamon twig, tangerine peel and amomum villosum from the above Chinese herbal composition, add 8 times the amount of water and distill for 4 hours to obtain volatile oil. Add 8 times the amount of water to the distilled residue and decoct for 1 hour. Filter the decoction to obtain filtrate 1. S2. Weigh out the following Chinese herbal medicines from the above-mentioned Chinese herbal medicine composition: Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos. Add 8 times the amount of water and decoct twice, 1.5 hours each time. Filter the decoction to obtain filtrate 2. S3. Combine filtrate 1 obtained in step S1 and filtrate 2 obtained in step S2, concentrate under reduced pressure to a thick paste, add ethanol until the ethanol content of the thick paste is 60%-80%, stir well, let stand for 24-36 hours, filter again, recover ethanol and concentrate, dry to make a dry extract, add the volatile oil obtained in step S1 and mix well to obtain the traditional Chinese medicine extract.

[0069] As an alternative implementation, the preparation method of the traditional Chinese medicine preparation includes the following steps: S1. Weigh out the cinnamon twig, tangerine peel and amomum villosum from the above Chinese herbal composition, add 8 times the amount of water and distill for 4 hours to obtain volatile oil. Add 8 times the amount of water to the distilled residue and decoct for 1 hour. Filter the decoction to obtain filtrate 1. S2. Weigh out the following Chinese herbal medicines from the above-mentioned Chinese herbal medicine composition: Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Imperata cylindrica, Morinda officinalis, and Poria cocos. Add 8 times the amount of water, decoct twice, 1.5 hours each time. Filter the decoction and combine it with filtrate 1 obtained in step S1. Concentrate under reduced pressure, cool, add ethanol to make the alcohol content reach 70%, stir, let stand for 24 hours, filter, and obtain filtrate 2.

[0070] S3. Weigh the Epimedium, Phellodendron bark, Lysimachia christinae, Pyrrosia lingua, and Dianthus superbus from the above-mentioned traditional Chinese medicine composition, add 8 times the amount of 70% ethanol, heat and reflux to extract twice, 1 hour each time, combine the extract with the filtrate 2 obtained in step S2, recover the ethanol under reduced pressure and concentrate to a thick paste, dry under vacuum at 70°C, pulverize, and mix with the volatile oil obtained in step S1 to obtain the traditional Chinese medicine composition.

[0071] Fourthly, the present invention provides a medicine comprising the above-mentioned traditional Chinese medicine composition and / or a traditional Chinese medicine extract prepared according to the processing method of the above-mentioned traditional Chinese medicine composition.

[0072] As an alternative implementation, the drug also contains pharmaceutically acceptable excipients and / or excipients.

[0073] As an alternative implementation, the pharmaceutically acceptable excipients include any one or a combination of at least two of the following: carriers, diluents, excipients, fillers, binders, wetting agents, emulsifiers, cosolvents, surfactants, or buffers.

[0074] As an alternative implementation, the dosage form of the drug is selected from decoctions, ointments, pills, lozenges, tablets, granules, powders, capsules, patches, oral liquids, or syrups.

[0075] Suitable drug carriers can be selected for different dosage forms. For example, the drug carrier used can be solid, liquid, or gaseous. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate, and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil, and water. Examples of gaseous carriers include carbon dioxide and nitrogen.

[0076] In preparing compositions for oral dosage forms, any convenient pharmaceutical medium can be used. For example, water, ethanol, oils, alcohols, flavoring agents, preservatives, coloring agents, etc., can be used to form oral liquid dosage forms, such as suspensions and solutions; while carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulators, emulsifiers, lubricants, binders, and disintegrants, can be used to form oral solid dosage forms, such as powders, capsules, and tablets. Tablets and capsules are preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or non-aqueous techniques.

[0077] Tablets containing the traditional Chinese medicine composition of the present invention can be prepared by compression or molding, and one or more excipients or adjuvants may be used. The active ingredient can be compressed in a free-flowing form (e.g., powder or granules) in a suitable machine, optionally mixed with binders, lubricants, inert diluents, surfactants, or dispersants. Molded tablets can be molded in a suitable machine, i.e., a mixture of powdered compounds moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of active ingredient. For example, a formulation intended for oral administration to humans may contain about 0.5 mg to about 5 g of active drug, mixed with a suitable and convenient carrier material, which may comprise about 5% to 95% of the total composition. Unit dosage forms typically contain about 1 mg to about 2 g of active ingredient, typically in doses of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg, or 1000 mg.

[0078] The pharmaceutical compositions of this invention suitable for parenteral administration can be prepared as aqueous solutions or suspensions of the active compound. Suitable surfactants, such as hydroxypropyl cellulose, may be included. Dispersions can also be prepared in mixtures of glycerol, liquid polyethylene glycol, and their oils. Furthermore, preservatives may be added to prevent harmful microbial growth.

[0079] The medicaments of the present invention can be in forms suitable for topical use, such as aerosols, creams, ointments, lotions, powders, or the like. Furthermore, the compositions can be in suitable forms for transdermal drug delivery devices. These formulations can be prepared using the traditional Chinese medicine compositions of the present invention through conventional processing methods. For example, a cream or ointment with a desired consistency can be prepared by mixing a hydrophilic material and water, and about 5 wt% to about 10 wt% of the compound.

[0080] The medicament of the present invention can be in a form suitable for rectal administration, wherein the carrier is solid. It is preferable to formulate the mixture into a single-dose suppository. Suitable carriers include cocoa butter and other materials commonly used in the art. Suppositories can be made by first forming a mixture containing a softened or melted carrier, followed by cooling and shaping in a mold.

[0081] In addition to the carrier components described above, the pharmaceutical formulations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, binders, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. Furthermore, other excipients may be added, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., colorants, and flavoring agents, etc., to make the formulation isotonic with the blood of the intended receptor. Components containing the traditional Chinese medicine composition of this invention can also be prepared in powder or concentrated form.

[0082] Fifthly, the present invention provides the use of the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine extract prepared according to the processing method of the above-mentioned traditional Chinese medicine composition, or the above-mentioned drug in the preparation of a drug for treating chronic prostatitis or related symptoms thereof.

[0083] Specifically, the chronic prostatitis described is a syndrome of damp-heat accumulation in the lower body combined with kidney yang deficiency.

[0084] Specifically, the chronic prostatitis described belongs to the syndrome of damp-heat accumulation in the lower jiao combined with kidney yang deficiency, with symptoms such as: frequent urination, urgency, burning and painful urethra during urination, yellow and cloudy urine, post-void dribbling, or incomplete emptying of the bladder, damp scrotum, irritability, shortness of breath, bitter taste in the mouth, and dry mouth; accompanied by cold limbs, soreness and weakness in the lower back and knees, decreased libido, red or pale red or pale and swollen tongue, yellow and greasy or white tongue coating, slippery and forceful or wiry and rapid pulse, or deep, slow or weak pulse.

[0085] In a sixth aspect, the present invention provides a method for treating chronic prostatitis or related symptoms thereof, comprising administering to a subject or patient a therapeutically effective amount or a safe and effective amount of the above-mentioned traditional Chinese medicine composition, a traditional Chinese medicine extract prepared according to the processing method of the above-mentioned traditional Chinese medicine composition, or the above-mentioned drug.

[0086] When administering the aforementioned traditional Chinese medicine composition, the traditional Chinese medicine extract prepared according to the processing method of the aforementioned traditional Chinese medicine composition, or the aforementioned drug, it may be administered as a single dose, stepwise dose, or in combination with other therapeutic agents, and the same dosage form as described above may be used. When the drugs are administered in a physical combination, the dosage form and route of administration should be selected based on the compatibility of the combined drugs. When administered as the sole active ingredient or in combination with a second active ingredient, the second active ingredient includes active ingredients known to be effective in treating chronic prostatitis or related symptoms thereof.

[0087] The traditional Chinese medicine composition, the traditional Chinese medicine extract prepared according to the processing method of the above-mentioned traditional Chinese medicine composition, or the above-mentioned drug are unit dosage forms suitable for single-dose administration of precise dosage. In some embodiments, the therapeutically effective amount or safe effective amount is in the range of about 0.001 mg / kg body weight / day to about 1000 mg / kg body weight / day. In some embodiments, the therapeutically effective amount or safe effective amount is about 0.5 mg / kg body weight / day to about 50 mg / kg body weight / day. In some embodiments, the therapeutically effective amount or safe effective amount is about 0.001 g / day to about 7 g / day. In some embodiments, the therapeutically effective amount or safe effective amount is about 0.002 g / day to about 6 g / day. In some administration methods, the therapeutically effective amount or safe effective amount is about 0.005 g / day to about 5 g / day. In some embodiments, the therapeutically effective amount or safe effective amount is about 0.01 g / day to about 5 g / day. In some embodiments, the therapeutically effective or safe effective amount is about 0.02 g / day to about 5 g / day. In some embodiments, the therapeutically effective or safe effective amount is about 0.05 g / day to about 2.5 g / day. In some embodiments, the therapeutically effective or safe effective amount is about 0.1 g / day to about 1 g / day. Dosage levels below the lower limit of the above ranges may be sufficient. In some embodiments, dosage levels above the upper limit of the above ranges may be required. In some embodiments, the compound is administered as a single dose once daily. In some embodiments, the compound is administered in multiple doses more than once daily. In some embodiments, the compound is administered twice daily. In some embodiments, the compound is administered three times daily. In other embodiments, the compound is administered four times daily. In other embodiments, the compound is administered more than four times daily. In some embodiments, the pharmaceutical composition is administered to a mammal. In some embodiments, the mammal is a human.

[0088] In this invention, Examples 1-5 at least support the protection scope of "the raw materials of the traditional Chinese medicine composition include: cinnamon twig, atractylodes macrocephala, alisma plantago-aquatica, tangerine peel, plantain seed, lysimachia christinae, dianthus superbus, pyrrosia lingua, imperata cylindrica root, phellodendron bark, morinda officinalis, epimedium, amomum villosum and poria cocos".

[0089] The above technical features are summarized from the foregoing explanation and / or the corresponding technical features in Examples 1-5: "Cinnamon twig, Atractylodes macrocephala, Alisma plantago-aquatica, Tangerine peel, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, Amomum villosum, and Poria cocos". Therefore, those skilled in the art can reasonably infer that the technical features "including: Cinnamon twig, Atractylodes macrocephala, Alisma plantago-aquatica, Tangerine peel, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, Amomum villosum, and Poria cocos", their subordinate concepts, their essentially equivalent technical means, and technical means that can be replaced within the conventional technical means and common knowledge based on the existing technical level, can achieve the effect of treating chronic prostatitis and are within its protection scope. For example, replacing "Alisma plantago-aquatica" with "salted Alisma plantago-aquatica" while keeping other technical features unchanged still falls within the protection scope of this invention.

[0090] In this invention, Embodiments 1-5, Embodiment 1, Embodiments 3-4, and Embodiment 1 respectively support at least the protection scope of the following technical features: "The raw materials of the Chinese herbal composition include: 2-6 parts of cinnamon twig, 1-5 parts of atractylodes macrocephala, 1-5 parts of alisma plantago-aquatica, 1-5 parts of tangerine peel, 4-8 parts of plantain seed, 4-8 parts of lysimachia christinae, 2-6 parts of dianthus superbus, 1-5 parts of pyrrosia lingua, 2-6 parts of imperata cylindrica root, 1-5 parts of phellodendron bark, 2-6 parts of morinda officinalis, 2-6 parts of epimedium, 1-5 parts of amomum villosum, and 1-5 parts of poria cocos." "The raw materials of the Chinese herbal composition include: 3-5 parts of cinnamon twig, 2-4 parts of atractylodes macrocephala, 2-4 parts of alisma plantago-aquatica, 2-4 parts of tangerine peel, 4-8 parts of plantain seed, 4-8 parts of lysimachia christinae, 3-5 parts of dianthus superbus, 2-4 parts of pyrrosia lingua, 3-5 parts of imperata cylindrica root, 2-4 parts of phellodendron bark, 3-5 parts of morinda officinalis, 3-5 parts of epimedium, 2-4 parts of amomum villosum, and 2-4 parts of poria cocos." "The traditional Chinese medicine composition is prepared from the following raw materials: 4 parts of cinnamon twig, 3 parts of atractylodes macrocephala, 3 parts of alisma plantago-aquatica, 3 parts of tangerine peel, 6 parts of plantain seed, 6 parts of lysimachia christinae, 4 parts of dianthus superbus, 3 parts of pyrrosia lingua, 4 parts of imperata cylindrica root, 3 parts of phellodendron bark, 4 parts of morinda officinalis, 4 parts of epimedium, 3 parts of amomum villosum, and 3 parts of poria cocos." The above-mentioned technical features and their subordinate concepts, their basically equivalent technical means, and technical means that can be replaced within the scope of conventional technical means and common knowledge based on the existing technical level, can all achieve further improvement in the treatment effect of chronic prostatitis and are all within the scope of protection of this invention. For example, if other technical features remain unchanged, replacing "2-6 parts of cinnamon twig" with "2.5 parts of cinnamon twig" or "2.2-5.5 parts of cinnamon twig", and replacing "1-5 parts of dried tangerine peel" with "3.5 parts of dried tangerine peel" or "2.5-3 parts of dried tangerine peel", etc., still falls within the scope of protection of this invention.

[0091] The beneficial effects of this invention are as follows: The present invention has at least the following beneficial effects: 1. Compared with existing technologies, this invention provides a technical solution with a different technical concept. Based on the principle of combining traditional Chinese medicine theory with modern pharmacological research, this invention uses a traditional Chinese medicine composition prepared from cinnamon twig, atractylodes macrocephala, alisma plantago-aquatica, tangerine peel, plantain seed, lysimachia christinae, dianthus superbus, pyrrosia lingua, imperata cylindrica root, phellodendron bark, morinda root, epimedium, amomum villosum, and poria cocos. This invention improves the synergistic effect between components by controlling the specific types and proportions of the drugs, resulting in a significant therapeutic effect on chronic prostatitis. This traditional Chinese medicine composition achieves both symptomatic and root-cause treatment through multi-target and multi-pathway synergistic action, and is particularly suitable for chronic prostatitis caused by damp-heat accumulation and kidney yang deficiency.

[0092] This invention demonstrates that the traditional Chinese medicine composition has a significant therapeutic effect on a rat model of chronic prostatitis: it significantly reduces the frequency of urination in the rats; it significantly reduces the prostate coefficient and IL-6 levels in the prostate tissue. This effect is superior to or close to that of traditional drugs for treating chronic prostatitis (such as Ningmitai capsules).

[0093] 2. This invention provides four preparation process routes: whole powder method, distillation and decoction method, distillation and decoction + water extraction and alcohol precipitation method, and distillation and decoction + water extraction and alcohol precipitation + alcohol extraction method. Experimental data show that the compositions prepared by the whole powder method and the distillation and decoction method are superior to the distillation and decoction + water extraction and alcohol precipitation method and the distillation and decoction + water extraction and alcohol precipitation + alcohol extraction method in reducing the frequency of urination, reducing the prostate coefficient and IL-6 level in prostate tissue of rats with chronic prostatitis.

[0094] In summary, this invention provides a traditional Chinese medicine composition with clear efficacy, good safety, convenient administration, and easy large-scale production. It is an important supplement and optimization to existing drugs for treating chronic prostatitis caused by damp-heat accumulation and kidney yang deficiency, and has significant clinical application value.

[0095] Furthermore, based on the present invention: Based on the comparison of Example 1 and Comparative Examples 1-14, it can be seen that the absence of any one component in the formulation of the present invention will lead to a significant decrease in the therapeutic effect. This indicates that the composition of the present invention, with its specific components working synergistically, achieves a more significant therapeutic effect on chronic prostatitis as a whole. Attached Figure Description

[0096] Figure 1 The effect of compositions 1 to 19 on the frequency of urination in rats with chronic prostatitis.

[0097] Figure 2 The effects of compositions 1 to 19 on the prostate coefficient in rats with chronic prostatitis.

[0098] Figure 3The effects of compositions 1 to 19 on IL-6 levels in prostate tissue of rats with chronic prostatitis. Detailed Implementation

[0099] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0100] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0101] In the following examples, the standard temperature for simmering is boiling.

[0102] Sodium carboxymethyl cellulose (CMC-Na) is commercially available and has the CAS number 9004-32-4.

[0103] In the following examples, the estradiol benzoate injection was manufactured by Shanghai Quanyu Biotechnology Animal Pharmaceutical Co., Ltd., with batch number 240337.

[0104] In the following examples, the manufacturer of the Servet 50 used is Vic Corporation of France, and the batch number is 9KWEA.

[0105] In the following examples, the manufacturer of the Sleepyhead II product was Dunhua Shengda Animal Pharmaceutical Co., Ltd., and the batch number was 20240106.

[0106] In the following examples, the rat IL-6 ELISA detection kit was manufactured by Wuhan Feien Biotechnology Co., Ltd., with batch number FN250825.

[0107] Example 1 The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by weight: 4 parts cinnamon twig, 3 parts atractylodes macrocephala, 3 parts alisma plantago-aquatica, 3 parts tangerine peel, 6 parts plantain seed, 6 parts lysimachia christinae, 4 parts dianthus superbus, 3 parts pyrrosia lingua, 4 parts imperata cylindrica root, 3 parts phellodendron chinense bark, 4 parts morinda officinalis, 4 parts epimedium, 3 parts amomum villosum, and 3 parts poria cocos (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 5).

[0108] Example 2 The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by weight: 6 parts cinnamon twig, 5 parts atractylodes macrocephala, 5 parts alisma plantago-aquatica, 5 parts tangerine peel, 8 parts plantain seed, 8 parts lysimachia christinae, 6 parts dianthus superbus, 5 parts pyrrosia lingua, 6 parts imperata cylindrica root, 5 parts phellodendron chinense bark, 6 parts morinda officinalis, 6 parts epimedium, 5 parts amomum villosum, and 5 parts poria cocos (see Table 1 for the composition ratio and dosage of the traditional Chinese medicine composition, Composition 16).

[0109] Example 3 The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by weight: 5 parts cinnamon twig, 4 parts atractylodes macrocephala, 4 parts alisma plantago-aquatica, 4 parts tangerine peel, 8 parts plantain seed, 8 parts lysimachia christinae, 5 parts dianthus superbus, 4 parts pyrrosia lingua, 5 parts imperata cylindrica root, 4 parts phellodendron chinense bark, 5 parts morinda officinalis, 5 parts epimedium, 4 parts amomum villosum, and 4 parts poria cocos (see Table 1 for the composition ratio and dosage of the traditional Chinese medicine composition, Composition 17).

[0110] Example 4 The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by weight: 2 parts cinnamon twig, 1 part atractylodes macrocephala, 1 part alisma plantago-aquatica, 1 part tangerine peel, 4 parts plantain seed, 4 parts lysimachia christinae, 2 parts dianthus superbus, 1 part pyrrosia lingua, 2 parts imperata cylindrica root, 1 part phellodendron chinense bark, 2 parts morinda officinalis, 2 parts epimedium, 1 part amomum villosum, and 1 part poria cocos (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 18).

[0111] Example 5 The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by weight: 3 parts cinnamon twig, 2 parts atractylodes macrocephala, 2 parts alisma plantago-aquatica, 2 parts tangerine peel, 4 parts plantain seed, 4 parts lysimachia christinae, 3 parts dianthus superbus, 2 parts pyrrosia lingua, 3 parts imperata cylindrica root, 2 parts phellodendron chinense bark, 3 parts morinda officinalis, 3 parts epimedium, 2 parts amomum villosum, and 2 parts poria cocos (see Table 1 for the composition ratio and dosage of the traditional Chinese medicine composition 19).

[0112] Comparative Example 1 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Epimedium is not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 1).

[0113] Comparative Example 2 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Phellodendron bark was not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 2).

[0114] Comparative Example 3 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Dianthus superbus was not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 3).

[0115] Comparative Example 4 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Lysimachia christinae is not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 4).

[0116] Comparative Example 5 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Alisma plantago-aquatica was not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 6).

[0117] Comparative Example 6 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Pyrrosia lingua was not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 7).

[0118] Comparative Example 7 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Morinda officinalis is not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 8).

[0119] Comparative Example 8 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that cinnamon twig is not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 9).

[0120] Comparative Example 9 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Plantago seed is not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 10).

[0121] Comparative Example 10 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that no dried tangerine peel is added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 11).

[0122] Comparative Example 11 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Poria cocos was not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 12).

[0123] Comparative Example 12 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Imperata cylindrica root was not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 13).

[0124] Comparative Example 13 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Amomum villosum was not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 14).

[0125] Comparative Example 14 The composition of the traditional Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Atractylodes macrocephala was not added (see Table 1 for the composition ratio and dosage of traditional Chinese medicine composition 15).

[0126] Table 1. Component Proportion and Dosage Table of Traditional Chinese Medicine Combinations

[0127] Experimental Example 1 I. Preparation of dry extract powder of traditional Chinese medicine composition Based on extensive research and clinical experience, this invention has found that a reasonable combination of cinnamon twig, atractylodes macrocephala, alisma plantago-aquatica, tangerine peel, plantain seed, lysimachia christinae, dianthus superbus, pyrrosia lingua, imperata cylindrica root, phellodendron bark, morinda officinalis, epimedium, amomum villosum, and poria cocos has a therapeutic effect on chronic prostatitis. According to the components and dosages in Table 1, weigh the combined Chinese herbal medicines, distill, extract, decoct, concentrate, and dry to prepare a dry extract powder. The specific preparation method is as follows: weigh 2 portions of the whole formula or decoction pieces, 15 times the daily prescription amount is 1 portion.

[0128] S1. Weigh out the prescribed amounts of cinnamon twig, dried tangerine peel, and amomum villosum from the above-mentioned Chinese herbal composition, add 8 times the amount of water and distill for 4 hours to obtain volatile oil; add 8 times the amount of water to the distilled residue and decoct for 1 hour, filter the decoction to obtain filtrate 1; S2. Weigh out the following ingredients from the above-mentioned Chinese herbal composition: Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos. Add 8 times the amount of water and decoct twice, 1.5 hours each time. Filter the decoction to obtain filtrate 2. S3. Combine filtrate 1 obtained in step S1 and filtrate 2 obtained in step S2, concentrate under reduced pressure to a thick paste (relative density of 1.10-1.40), dry under vacuum at 70°C, pulverize, add the volatile oil obtained in step S1 and mix well to obtain the traditional Chinese medicine extract.

[0129] II. Determining the efficacy of each composition in treating chronic prostatitis 1. Experimental Methods Six- to eight-week-old SPF-grade male SD rats that passed quarantine were selected. Eight rats were chosen as the sham-operated control group, and the remaining animals were used to establish the chronic prostatitis model. A chronic prostatitis model was established by castration combined with subcutaneous injection of estradiol benzoate for four weeks. The number of urinations was measured, and the successfully modeled animals were randomly divided into a model control group, a positive control group, and experimental groups 1 to 19, with eight rats in each group. Drug administration began the day after grouping. The positive control group was administered Ningmitai capsules (398 mg / kg, 10 ml / kg) by gavage, while the sham-operated group and the model control group were administered 0.5% carboxymethyl cellulose sodium solution (0.5% CMC-Na, 10 ml / kg) by gavage. (ml / kg), experimental groups 1 to 19 were administered drug suspensions of compositions 1 to 19 by gavage (dose of 4.29 g crude drug / kg, 4.34 g crude drug / kg, 4.29 g crude drug / kg, 4.08 g crude drug / kg, 4.61 g crude drug / kg, 4.34 g crude drug / kg, 4.34 g crude drug / kg, 4.29 g crude drug / kg, 4.2 g crude drug / kg, 4.08 g crude drug / kg, 4.34 g crude drug / kg, 4.34 g crude drug / kg, 4.29 g crude drug / kg, 4.34 g crude drug / kg, 4.34 g crude drug / kg, 7.07 g crude drug / kg, 6.02 g crude drug / kg, 2.20 g crude drug / kg, and 3.25 g crude drug / kg, respectively, all of which were clinically equivalent doses in rats, and the solvent of the suspension was 0.5% CMC-Na, all at 10 ml / kg). The drug was administered once daily for 7 consecutive days. The final test included the number of urinations in the animals, weighing the prostate tissue and calculating the prostate coefficient, as well as measuring the IL-6 level in the prostate tissue.

[0130] 2. Experimental Results (1) Frequency of urination: The effects of compositions 1 to 19 on the frequency of urination in rats with chronic prostatitis are as follows: Figure 1As shown, at D0 and D7, compared with the normal control group, the number of urinations in the model control group rats increased, with statistically significant differences (P<0.01). Compared with the model control group, at D0, the values ​​among the groups were similar, with no statistical difference. At D7, the number of urinations in all drug groups decreased, except for experimental groups 1, 4, 8, and 10, where there were statistically significant differences (P<0.05 or 0.01). Compared with experimental group 5, at D0, the values ​​among the groups were similar, with no statistical difference. At D7, the number of urinations in all drug groups increased, except for experimental groups 12, 13, 16, 17, 18, and 19, where there were statistically significant differences (P<0.05 or 0.01). On day 7, the mean number of urinations in the positive control group and each drug group, from lowest to highest, was as follows: experimental group 5 < experimental group 16 < positive control group < experimental group 17 < experimental group 19 < experimental group 18 < experimental group 12 < experimental group 13 < experimental group 14 < experimental group 11 < experimental group 15 < experimental group 9 < experimental group 6 < experimental group 2 < experimental group 7 < experimental group 3 < experimental group 1 < experimental group 8 < experimental group 4 < experimental group 10.

[0131] (2) Prostate coefficient: The effects of compositions 1 to 19 on the prostate coefficient in rats with chronic prostatitis are as follows Figure 2 As shown, compared with the normal control group, the prostate coefficient of rats in the model control group was decreased, with a statistically significant difference (P<0.01); compared with the model control group, except for experimental groups 4, 8, and 10, the prostate coefficient of rats in all other drug groups was increased, and among them, except for the positive control group and experimental group 1, all drug groups showed statistically significant differences (P<0.05 or 0.01); compared with experimental group 5, except for experimental groups 16, 17, and 19 which were the same as the experimental group, the prostate coefficient of rats in all other drug groups was decreased, among which experimental groups 1, 4, 8, and 10 showed statistically significant differences (P<0.05 or 0.01). The mean prostate coefficients of the positive control group and each drug group, from highest to lowest, were as follows: experimental group 5, experimental group 16, experimental group 17, experimental group 19 > experimental group 12, experimental group 13, experimental group 18 > experimental group 6, experimental group 9, experimental group 11, experimental group 14, experimental group 15 > experimental group 2, experimental group 3, experimental group 7 > positive control group > experimental group 1 > experimental group 8 > experimental group 4 > experimental group 10.

[0132] (3) IL-6 level in prostate tissue: The effects of compositions 1 to 19 on IL-6 levels in prostate tissue of rats with chronic prostatitis are as follows: Figure 3As shown, compared with the normal control group, the IL-6 level in the prostate tissue of rats in the model control group was increased, with a statistically significant difference (P<0.01); compared with the model control group, the IL-6 level in the prostate tissue of mice in each drug group was decreased, except for experimental groups 4, 8, and 10, all other drug groups showed statistically significant differences (P<0.05 or 0.01); compared with experimental group 5, the IL-6 level in each drug group was increased, with statistically significant differences (P<0.05 or 0.01). The average IL-6 level in the positive control group and each drug group, from lowest to highest, was: experimental group 5 < positive control group < experimental group 16 < experimental group 17 < experimental group 19 < experimental group 18 < experimental group 12 < experimental group 13 < experimental group 14 < experimental group 11 < experimental group 15 < experimental group 9 < experimental group 6 < experimental group 2 < experimental group 7 < experimental group 3 < experimental group 1 < experimental group 8 < experimental group 4 < experimental group 10.

[0133] The effects of compositions 1 to 19 on rats with chronic prostatitis are shown in Table 2. The results indicate that compositions 2, 3, 5, 6, 7, 9, 11, 12, 13, 14, 15, 16, 17, 18, and 19 have significant therapeutic effects on rats with chronic prostatitis established by castration combined with estrogen injection. These compositions can exert significant therapeutic effects after 7 days of administration. Among them, the therapeutic effect of composition 5 is significantly better than that of the other groups. At the same dosage, the overall efficacy ranking is as follows: group 5 > group 16 > group 17 > group 19 > group 18 > group 12 > group 13 > group 14 > group 11 > group 15 > group 9 > group 6 > group 2 > group 7 > group 3 > group 1 > group 8 > group 4 > group 10.

[0134] Table 2. Effects of compositions 1 to 19 on rats with chronic prostatitis ( (n=8)

[0135] Note: vs. normal control group, ##P<0.01; vs. model control group, P<0.01, P<0.05; vs. experimental group 5, ^^P<0.01, ^P<0.05.

[0136] In summary, the results show that the compositions prepared in the embodiments of the present invention have a significant therapeutic effect on a rat model of chronic prostatitis, with the best effect observed in the formulation of Example 1 (experimental group 5). The results of Comparative Examples 1-4 and 6-15 indicate that the absence of any one component leads to a significant decrease in therapeutic effect, demonstrating that the compositions of the present invention, with their specific components working synergistically, achieve a more significant therapeutic effect on chronic prostatitis as a whole.

[0137] Example 7: Process Route Study I. Process Route 1 (Whole Powder Medicinal Group) According to the proportions provided in Example 1, weigh out 2 parts of the whole prescription herbs or decoction pieces, and 5 times the daily prescription amount as 1 part. Weigh out the following herbs respectively: cinnamon twig, tangerine peel, amomum villosum, atractylodes macrocephala, alisma plantago-aquatica, plantain seed, lysimachia christinae, dianthus superbus, pyrrosia lingua, imperata cylindrica root, phellodendron bark, morinda officinalis, epimedium, and poria cocos. Sterilize at 105℃ for 30 minutes, dry at 60℃, pulverize into fine powder, pass through a 100-mesh sieve, and mix at 10 rpm for 30 minutes to obtain the final product.

[0138] II. Process Route 2 (Distillation and Decoction Group) According to the proportions provided in Example 1, weigh out 2 parts of the whole prescription herbs or decoction pieces, and 15 times the daily prescription amount as 1 part. Weigh out cinnamon twig, tangerine peel, and amomum villosum respectively, add 8 times the amount of water, and distill to extract the volatile oil. Set aside the volatile oil. Filter the distilled aqueous solution and set aside the filtrate. Add 8 times the amount of water to the dregs and decoct for 1 hour. Filter the decoction and set aside the filtrate.

[0139] Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos are decocted twice with 8 times the amount of water, each time for 1.5 hours. The decoction is filtered and combined with the filtrate of Cinnamomum cassia, etc., and concentrated under reduced pressure to a thick paste with a relative density of 1.10-1.40 (60℃). The paste is then vacuum dried at 70℃, pulverized, and mixed with the volatile oil of Cinnamomum cassia, etc., to obtain the final product.

[0140] III. Process Route 3 (Distillation and Decoction + Water Extraction and Alcohol Precipitation) According to the proportions provided in Example 1, weigh out 2 parts of the whole prescription herbs or decoction pieces, and 15 times the daily prescription amount as 1 part. Weigh out cinnamon twig, tangerine peel, and amomum villosum respectively, add 8 times the amount of water, and distill to extract the volatile oil. Set aside the volatile oil. Filter the distilled aqueous solution and set aside the filtrate. Add 8 times the amount of water to the dregs and decoct for 1 hour. Filter the decoction and set aside the filtrate.

[0141] Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos are decocted twice with 8 times the amount of water, each time for 1.5 hours. The decoction is filtered and combined with the filtrate of Cinnamomum cassia, etc., and concentrated under reduced pressure to a clear paste with a relative density of 1.10-1.15 (60℃). The paste is cooled, and ethanol is added to make the alcohol content reach 70%. The paste is stirred and allowed to stand for 24 hours. The paste is then filtered, and the ethanol is recovered from the filtrate under reduced pressure. The paste is then concentrated to a thick paste with a relative density of 1.10-1.40 (60℃). The paste is dried under vacuum at 70℃, pulverized, and mixed with the volatile oil of Cinnamomum cassia, etc., to obtain the final product.

[0142] IV. Process Route 4 (Distillation and decoction + water extraction and alcohol precipitation + alcohol extraction group) According to the proportions provided in Example 1, weigh out 2 parts of the whole prescription herbs or decoction pieces, and 15 times the daily prescription amount as 1 part. Weigh out cinnamon twig, tangerine peel, and amomum villosum respectively, add 8 times the amount of water, and distill to extract the volatile oil. Set aside the volatile oil. Filter the distilled aqueous solution and set aside the filtrate. Add 8 times the amount of water to the dregs and decoct for 1 hour. Filter the decoction and set aside the filtrate.

[0143] Add 8 times the amount of water to Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Imperata cylindrica, Morinda officinalis, and Poria cocos, and decoct twice for 1.5 hours each time. Filter the decoction and combine it with the filtrate of Cinnamomum cassia, etc., and concentrate it under reduced pressure to a clear extract with a relative density of 1.10-1.15 (60℃). Let it cool, add ethanol to make the alcohol content reach 70%, stir, let it stand for 24 hours, filter, and keep the filtrate for later use.

[0144] Epimedium, Phellodendron bark, Lysimachia christinae, Pyrrosia lingua, and Dianthus superbus are extracted twice by heating and refluxing with 8 times the amount of 70% ethanol, each time for 1 hour. The extract is combined with the supernatant of Atractylodes macrocephala and other alcohol-precipitated products. The ethanol is recovered under reduced pressure and the extract is concentrated to a thick paste with a relative density of 1.10-1.40 (60℃). The paste is then dried under vacuum at 70℃, pulverized, and mixed with volatile oils such as Cinnamomum cassia to obtain the final product.

[0145] V. Sample Preparation Data The sample preparation data are shown in Table 3. The results show that all four process routes successfully prepared the corresponding samples.

[0146] Table 3. Sample Preparation Data Table

[0147] VI. Determining the efficacy of different treatment methods for chronic prostatitis 1. Experimental Methods Male SPF-grade SD rats aged 6-8 weeks (quarantined and certified) were selected. Eight rats were chosen as the sham-operated control group, and the remaining animals were used to establish the chronic prostatitis model. A chronic prostatitis model was established by castration combined with subcutaneous injection of estradiol benzoate for 4 weeks. Urination frequency was measured, and the successfully modeled animals were randomly divided into four groups based on urination frequency: model control group, positive control group, process group 1, process group 2, process group 3, and process group 4, with eight rats in each group. Drug administration began the day after grouping. The positive control group was administered Ningmitai capsules (398 mg / kg, 10 ml / kg) by gavage. The sham-operated group and model control group were administered 0.5% sodium carboxymethyl cellulose solution (0.5% CMC-Na, 10 ml / kg) by gavage. Process groups 1 to 4 were administered drug suspensions of process road test samples 1 to 4 by gavage (dose: 4.61 g crude drug / kg, the clinically equivalent dose for rats; suspension solvent: 0.5% CMC-Na, 10 ml / kg). Administered once daily for 7 consecutive days. The final test included counting the number of times animals urinated, weighing prostate tissue and calculating the prostate coefficient, and measuring the IL-6 level in the prostate tissue.

[0148] 2. Experimental Results (1) Number of urinations: On D0 and D7, compared with the normal control group, the number of urinations in the model control group increased, which was statistically significant (P<0.01); compared with the model control group, on D0, the values ​​of each group were similar and there was no statistical difference; on D7, the number of urinations in each drug group decreased, which was statistically significant (P<0.05 or 0.01), and the mean values ​​from low to high were: process group 2 < process group 1 < process group 3, positive control group < process group 4.

[0149] (2) Prostate coefficient: Compared with the normal control group, the prostate coefficient of rats in the model control group was reduced, which showed a statistical difference (P<0.01); compared with the model control group, the prostate coefficient of rats in each drug group was increased, which showed a statistical difference (P<0.05 or 0.01), and the mean values ​​from high to low were: process 1 group, process 2 group > process 3 group > process 4 group, positive control group.

[0150] (3) IL-6 level in prostate tissue: Compared with the normal control group, the IL-6 level in the prostate tissue of rats in the model control group was increased, which was statistically significant (P<0.01); compared with the model control group, the IL-6 level in the prostate tissue of rats in each drug group was decreased, which was statistically significant (P<0.05 or 0.01), and the mean values ​​from low to high were: Group 1 < Group 2 < Positive control group, Group 3 < Group 4.

[0151] 3. Conclusion The effects of different processing routes on rats with chronic prostatitis are shown in Table 4. Under the conditions of this experiment, each process sample had a significant therapeutic effect on castration combined with subcutaneous injection of estradiol benzoate in the chronic prostatitis model animals, which could reduce the number of urinations, the IL-6 level in the prostate tissue, and increase the prostate coefficient.

[0152] Among them, process samples 1 and 2 are slightly better than Ningmitai capsules, process sample 3 and process sample 4.

[0153] Table 4. Effects of different processing routes on rats with chronic prostatitis ( (n=8)

[0154] Note: vs. normal control group, ##P<0.01; vs. model control group, P<0.01, P<0.05.

[0155] Example 8 Weigh out the whole medicinal materials or decoction pieces according to the proportion of the traditional Chinese medicine composition in Example 1. Take cinnamon twig, tangerine peel, and amomum villosum, add 8 times the amount of water, and distill to extract the volatile oil. Set the volatile oil aside. Filter the aqueous solution after distillation and set the filtrate aside. Add 8 times the amount of water to the dregs and decoct for 1 hour. Filter the decoction and set the filtrate aside.

[0156] Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos are decocted twice with 8 times the amount of water, each time for 1.5 hours. The decoction is filtered and combined with the filtrate of Cinnamomum cassia, etc., and concentrated under reduced pressure to a suitable thick paste. After cooling, ethanol is added to bring the alcohol content to 60%, stirred well, and allowed to stand for 24 hours. The paste is then filtered, and the ethanol is recovered from the filtrate and concentrated to an extract with a relative density of 1.15~1.20 (60℃). Water is added to approximately the fixed volume, stirred well, and refrigerated (4-7°C) for 36-48 hours. The paste is then filtered. Separately, sucrose is boiled with water to make a syrup, which is added to the above filtrate. Sodium benzoate and cyclamate are added, water is added to the fixed volume, stirred well, sterilized, and bottled to obtain the oral liquid.

[0157] Example 9 Weigh out the whole medicinal materials or decoction pieces according to the proportion of the traditional Chinese medicine composition in Example 1. Take cinnamon twig, tangerine peel, and amomum villosum, add 8 times the amount of water, and distill to extract the volatile oil. Set the volatile oil aside. Filter the aqueous solution after distillation and set the filtrate aside. Add 8 times the amount of water to the dregs and decoct for 1 hour. Filter the decoction and set the filtrate aside.

[0158] Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos are decocted twice with 8 times the amount of water, each time for 1.5 hours. The decoction is filtered and combined with the filtrate of Cinnamomum cassia, etc., and concentrated under reduced pressure to a suitable thick paste. It is then dried, pulverized, and mixed with appropriate excipients to form granules. The granules are then sized, mixed with volatile oils such as Cinnamomum cassia, and packaged to obtain the final product.

[0159] Example 10 Weigh out the whole medicinal materials or decoction pieces according to the proportion of the traditional Chinese medicine composition in Example 1. Take cinnamon twig, tangerine peel, and amomum villosum, add 8 times the amount of water, and distill to extract the volatile oil. Set the volatile oil aside. Filter the aqueous solution after distillation and set the filtrate aside. Add 8 times the amount of water to the dregs and decoct for 1 hour. Filter the decoction and set the filtrate aside.

[0160] Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos are decocted twice with 8 times the amount of water, each time for 1.5 hours. The decoction is filtered and combined with the filtrate of Cinnamomum cassia and other ingredients. The mixture is concentrated under reduced pressure to a suitable consistency. Appropriate amounts of excipients are added, and the mixture is granulated, dried, and sized. The volatile oils of Cinnamomum cassia and other ingredients are added, mixed well, and packaged to obtain the granules.

[0161] Example 11 Weigh all the medicinal materials or decoction pieces according to the proportions of the traditional Chinese medicine composition in Example 1, sterilize them with moist heat at 105℃ for 30 minutes, dry them at 60℃, pulverize them into fine powder, pass them through a 100-mesh sieve, mix them at 10 rpm for 30 minutes, add an appropriate amount of excipients, make wet pills with a suitable wetting agent or binder, dry them, select the pills, and package them to obtain the pills.

[0162] Example 12 Weigh out the whole medicinal materials or decoction pieces according to the proportion of the traditional Chinese medicine composition in Example 1. Take cinnamon twig, tangerine peel, and amomum villosum, add 8 times the amount of water, and distill to extract the volatile oil. Set the volatile oil aside. Filter the aqueous solution after distillation and set the filtrate aside. Add 8 times the amount of water to the dregs and decoct for 1 hour. Filter the decoction and set the filtrate aside.

[0163] Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos are decocted twice with 8 times the amount of water, each time for 1.5 hours. The decoction is filtered and combined with the filtrate of Cinnamomum cassia and other herbs. The mixture is concentrated under reduced pressure to a suitable consistency, dried, pulverized, and mixed with appropriate excipients to form granules. The granules are then dried, compressed into tablets, and packaged to obtain tablets.

[0164] Example 13 Weigh out the whole medicinal materials or decoction pieces according to the proportion of the traditional Chinese medicine composition in Example 1. Take cinnamon twig, tangerine peel, and amomum villosum, add 8 times the amount of water, and distill to extract the volatile oil. Set the volatile oil aside. Filter the aqueous solution after distillation and set the filtrate aside. Add 8 times the amount of water to the dregs and decoct for 1 hour. Filter the decoction and set the filtrate aside.

[0165] Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos are decocted twice with 8 times the amount of water, each time for 1.5 hours. The decoction is filtered and combined with the filtrate of Cinnamomum cassia and other herbs. The mixture is concentrated under reduced pressure to a suitable consistency, dried, pulverized, and mixed with appropriate excipients to form granules. These granules are then filled into capsules and packaged to obtain capsules.

[0166] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for clearing heat and dampness, warming the kidneys and tonifying yang, characterized in that, According to the weight parts, the raw materials of the traditional Chinese medicine composition are: 2-6 parts of cinnamon twig, 1-5 parts of atractylodes macrocephala, 1-5 parts of alisma plantago-aquatica, 1-5 parts of tangerine peel, 4-8 parts of plantain seed, 4-8 parts of lysimachia christinae, 2-6 parts of dianthus superbus, 1-5 parts of pyrrosia lingua, 2-6 parts of imperata cylindrica root, 1-5 parts of phellodendron bark, 2-6 parts of morinda officinalis, 2-6 parts of epimedium, 1-5 parts of amomum villosum, and 1-5 parts of poria cocos. The traditional Chinese medicine composition is used to treat chronic prostatitis; The preparation method of the traditional Chinese medicine composition includes the following steps: S1. Cinnamon twig, dried tangerine peel, and amomum villosum were distilled to extract volatile oil; the distilled residue was boiled with water to extract the oil, and the decoction was filtered to obtain filtrate 1. S2. Extract the following herbs with solvent: Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos. Filter the mixture to obtain filtrate 2. S3. Combine filtrate 1 obtained in step S1 and filtrate 2 obtained in step S2, and add the volatile oil obtained in step S1 to obtain the traditional Chinese medicine extract; The solvent extraction described in step S2 is a decoction extraction with water.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw material composition of the traditional Chinese medicine composition, by weight, is as follows: Cinnamon twig 3-5 parts, Atractylodes macrocephala 2-4 parts, Alisma plantago-aquatica 2-4 parts, Citrus reticulata peel 2-4 parts, Plantago asiatica seed 4-8 parts, Lysimachia christinae 4-8 parts, Dianthus superbus 3-5 parts, Pyrrosia lingua 2-4 parts, Imperata cylindrica root 3-5 parts, Phellodendron chinense bark 2-4 parts, Morinda officinalis root 3-5 parts, Epimedium brevicornu 3-5 parts, Amomum villosum 2-4 parts, Poria cocos 2-4 parts.

3. A method for processing the traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, Includes the following steps: S1. Cinnamon twig, dried tangerine peel, and amomum villosum were distilled to extract volatile oil; the distilled residue was boiled with water to extract the oil, and the decoction was filtered to obtain filtrate 1. S2. Extract the following herbs with solvent: Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos. Filter the mixture to obtain filtrate 2. S3. Combine filtrate 1 obtained in step S1 and filtrate 2 obtained in step S2, and add the volatile oil obtained in step S1 to obtain the traditional Chinese medicine extract; In step S2, the solvent extraction is performed by boiling with water.

4. The processing method according to claim 3, characterized in that, In step S1, the distillation extraction is performed by adding 6-10 times the total mass of the raw materials to water, and distilling 1-3 times, with each extraction lasting 1-4 hours.

5. The processing method according to claim 3, characterized in that, The water-boiling extraction described in steps S1 and S2 is as follows: add 6-12 times the total mass of the raw materials to water, boil and extract 1-3 times, each time for 1-4 hours.

6. The processing method according to claim 3, characterized in that, Includes the following steps: S1. Weigh out the cinnamon twig, tangerine peel, and amomum villosum from the Chinese herbal composition, add 8 times the amount of water and distill for 4 hours to obtain volatile oil; add 8 times the amount of water to the distilled residue and decoct for 1 hour, filter the decoction to obtain filtrate 1; S2. Weigh out the remaining Atractylodes macrocephala, Alisma plantago-aquatica, Plantago asiatica, Lysimachia christinae, Dianthus superbus, Pyrrosia lingua, Imperata cylindrica, Phellodendron chinense, Morinda officinalis, Epimedium brevicornu, and Poria cocos from the Chinese herbal composition, add 8 times the amount of water, decoct twice, 1.5 hours each time, filter the decoction to obtain filtrate 2. S3. Combine the filtrate 1 obtained in step S1 and the filtrate 2 obtained in step S2, concentrate under reduced pressure to a thick paste, dry under vacuum at 70°C, pulverize, add the volatile oil obtained in step S1 and mix well to obtain the traditional Chinese medicine extract.

7. A drug, characterized in that, Made from the traditional Chinese medicine composition according to any one of claims 1-2 and / or the traditional Chinese medicine extract prepared according to the processing method according to any one of claims 3-6.

8. The medicament according to claim 7, characterized in that, The dosage form of the drug is selected from decoction, ointment, pill, lozenge, tablet, granule, powder, capsule or oral liquid.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-2, the traditional Chinese medicine extract prepared according to the processing method according to any one of claims 3-6, or the drug according to any one of claims 7-8 in the preparation of a drug for treating chronic prostatitis or related symptoms thereof.

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