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

Abstract

The invention relates to the field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for treating chronic prostatitis and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 5-15 parts of pericarpium citri reticulatae viride; 5-15 parts of szechwan chinaberry fruit; 5-15 parts of the root of three-nerved spicebush; 5-15 parts of radix angelicae dahuricae; 10-20 parts of herba lycopi; 10 to 20 parts of herba patriniae; 4 to 8 parts of frankincense; 4 to 8 parts of myrrh; 5 to 15 parts of rhizoma corydalis; 10 to 20 parts of caulis spatholobi; 5 to 15 parts of diverse wormwood herb; 10 to 20 parts of cowherb seed; 5-15 parts of radix curcumae; and 4-8 parts of fennel. The traditional Chinese medicine composition can significantly improve the symptoms of chronic prostatitis, regulate the syndromes of traditional Chinese medicine and improve the life quality of patients, and has good safety and patient compliance.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine, particularly to a traditional Chinese medicine composition for treating chronic prostatitis, and a preparation method and application thereof. BACKGROUND

[0002] Chronic prostatitis is a common male urological disease, with an incidence rate of up to 15% in male diseases. Patients often exhibit a series of symptoms, such as frequent urination, urgent urination, painful urination, burning sensation in the urethra, dribbling, and pain, distension, or discomfort in the scrotum, testicles, lower abdomen, perineum, waist, and sacrum. In addition, patients may also experience dizziness, tinnitus, insomnia, anxiety, depression, and other symptoms, which severely affect the quality of life of patients.

[0003] Currently, one of the commonly used treatment drugs in clinical practice is Qianlieshule Capsules. This drug is composed of Puhuang, Cheqiancao, Chuan Niuxi, Yinyanghe, and Huangqi, and has the functions of activating blood and resolving stasis, and diuresis and relieving stranguria, and is mainly used for treating symptoms such as frequent urination, urgent urination, poor urination, and lower abdominal pain.

[0004] However, the existing treatment methods still have some deficiencies, for example:

[0005] Limited treatment range: Qianlieshule Capsules are mainly suitable for patients with qi stagnation and blood stasis, and have limited efficacy for chronic prostatitis caused by damp-heat accumulation. This is because the syndrome differentiation of this drug is mainly qi stagnation and blood stasis, and the components are mainly blood-activating and qi-moving drugs, which have poor treatment effect on patients with damp-heat.

[0006] High treatment cost: Compared with other drugs, Qianlieshule Capsules are relatively expensive. For chronic prostatitis patients who need long-term or repeated treatment, this may cause great economic pressure. The high price is mainly due to the high manufacturing cost of the capsule dosage form.

[0007] Incomplete treatment effect: Existing drugs often only target part of the symptoms, such as activating blood and resolving stasis or diuresis and relieving stranguria, and lack comprehensive treatment for various causes and symptoms of chronic prostatitis. This may result in ineffective relief of some symptoms.

[0008] Poor long-term efficacy: The existing treatment methods do not have ideal long-term control effect on chronic prostatitis, and patients are prone to repeated attacks, affecting the quality of life.

[0009] Insufficient individualized treatment: Existing drugs are difficult to meet the individualized treatment needs of patients with different syndromes, especially for patients with both qi stagnation and blood stasis and damp-heat accumulation, and lack of treatment programs that take into account both syndromes.

[0010] Safety and tolerability issues: Some existing treatment methods may have adverse reactions, affecting patient medication adherence and long-term treatment effect.

[0011] Therefore, there is an urgent need for a new treatment scheme that can comprehensively solve the above problems to improve the treatment effect of chronic prostatitis and improve the quality of life of patients. SUMMARY

[0012] The present application aims to provide a traditional Chinese medicine composition for treating chronic prostatitis, a preparation method and application thereof, to solve the problems raised in the background art.

[0013] The present application discloses a traditional Chinese medicine composition for treating chronic prostatitis, which is composed of the following raw materials in parts by mass:

[0014] 5-15 parts of pericarpium citri reticulatae viride; 5-15 parts of melia toosendan fruit; 5-15 parts of lindera aggregata; 5-15 parts of radix angelicae dahuricae; 10-20 parts of lycopi herba; 10-20 parts of herba patriniae; 4-8 parts of olibanum; 4-8 parts of myrrha; 5-15 parts of rhizoma corydalis; 10-20 parts of caulis et ramus youngiae; 5-15 parts of rhizoma coptidis; 10-20 parts of herba epimedii; 5-15 parts of radix curcumae; 4-8 parts of foeniculum vulgare.

[0015] In a preferred embodiment, the traditional Chinese medicine composition is used for treating chronic prostatitis of the type of qi stagnation and blood stasis and / or damp-heat accumulation.

[0016] In a preferred embodiment, the traditional Chinese medicine composition is composed of the following raw materials in parts by mass:

[0017] Pericarpium citri reticulatae viride 10 parts, melia toosendan fruit 10 parts, lindera aggregata 10 parts, radix angelicae dahuricae 10 parts, lycopi herba 15 parts, herba patriniae 15 parts, olibanum 6 parts, myrrha 6 parts, rhizoma corydalis 10 parts, caulis et ramus youngiae 15 parts, rhizoma coptidis 10 parts, herba epimedii 15 parts, radix curcumae 10 parts, and foeniculum vulgare 6 parts.

[0018] The present application also discloses an application of the traditional Chinese medicine composition as described above in the preparation of a medicine for treating chronic prostatitis of the type of qi stagnation and blood stasis and / or damp-heat accumulation.

[0019] The present application also discloses a traditional Chinese medicine preparation composed of the traditional Chinese medicine composition as described above and pharmaceutically acceptable adjuvants.

[0020] In a preferred embodiment, the dosage form of the traditional Chinese medicine preparation is decoction, pill, tablet, granule, powder, paste or capsule.

[0021] The present application also discloses a preparation method of the traditional Chinese medicine composition as described above, which comprises: mixing and extracting raw materials to obtain the traditional Chinese medicine preparation.

[0022] In a preferred embodiment, when the traditional Chinese medicine preparation is decoction, the preparation method comprises:

[0023] cleaning each traditional Chinese medicine component;

[0024] Weigh each traditional Chinese medicine component according to the formula proportion;

[0025] Soak each traditional Chinese medicine component in water for 30 minutes;

[0026] Transfer the soaked medicine into a decoction container and add water to cover the medicine;

[0027] Boil with strong fire and then change to medium heat for 30 minutes, filter out the medicine liquid;

[0028] Add water and decoct for the second time, filter out the medicine liquid;

[0029] Combine the medicine liquids from the two decoctions.

[0030] The application also discloses an application of the traditional Chinese medicine preparation as described above in the preparation of a medicine for treating chronic prostatitis.

[0031] In a preferred example, the dosage of the traditional Chinese medicine preparation is: 1 dose per day, taken twice, and 2 months as a treatment course.

[0032] The traditional Chinese medicine composition Qinglin Formula provided by the application shows significant clinical effects and advantages in treating chronic prostatitis. The specific technical effects are as follows:

[0033] Comprehensively improve clinical symptoms: Qinglin Formula significantly improves the clinical symptoms of patients with chronic prostatitis. After 8 weeks of treatment, the NIH-CPSI score of the patients is reduced from 24.5 to 12.3 on average, with an improvement rate of 49.80%, which is significantly better than the control group (13.82%) and the comparative scheme. This shows that Qinglin Formula can effectively relieve pain, improve urination symptoms and improve the quality of life.

[0034] Significantly improve the effective rate of treatment: after 8 weeks of treatment with Qinglin Formula, the significant efficiency reaches 58.00%, and the total effective rate is as high as 96.00%, which are significantly higher than those of the control group and the comparative scheme. This means that Qinglin Formula can bring significant improvement to most patients.

[0035] Effectively regulate TCM syndromes: after 8 weeks of treatment with Qinglin Formula, the TCM syndrome score of the patients is reduced from 18.6 to 8.2 on average, with an improvement rate of 55.91%, which is significantly better than the control group and the comparative scheme. This shows that Qinglin Formula can effectively regulate TCM syndromes such as qi stagnation and blood stasis, and damp-heat accumulation.

[0036] Significantly control inflammation: after 8 weeks of treatment with Qinglin Formula, the WBC count of the prostate fluid of the patients is reduced from 25.3 / HP to 8.2 / HP, with an improvement rate of 67.59%, which is better than the control group and the comparative scheme. This shows that Qinglin Formula can effectively inhibit and control the inflammatory response of the prostate.

[0037] Significant improvement in urinary function: After 8 weeks of treatment with Qinglinfang, the patients' maximum urinary flow rate increased from 10.2 ml / s to 16.8 ml / s, an improvement rate of 64.71%, which was significantly better than the control group and the comparison program. This reflects the unique advantage of Qinglinfang in improving urinary function.

[0038] Significantly improved patient satisfaction: After 8 weeks of treatment with Qinglinfang, the patient satisfaction score reached 87.5 points, far exceeding that of the control group and the comparison program. This reflects the high level of patient recognition of the therapeutic effect of Qinglinfang.

[0039] Good safety profile: After 8 weeks of treatment with Qinglinfang, only 4% of patients experienced mild adverse reactions, mainly mild gastrointestinal reactions, which resolved without special treatment. This indicates that Qinglinfang has good safety and tolerability.

[0040] Synergistic effect across multiple targets: Qinglin Formula achieves comprehensive therapeutic effects through multiple mechanisms, including promoting qi circulation and relieving pain (green tangerine peel, Sichuan pepper, Lindera root), clearing heat and promoting diuresis (Eupatorium fortunei, Patrinia scabiosaefolia), and activating blood circulation and removing blood stasis (Spatholobus suberectus, Corydalis yanhusuo). This unique formula not only improves local symptoms but also regulates the overall qi and blood circulation and damp-heat state, achieving a holistic treatment effect.

[0041] Ease of use: Qinglinfang is a traditional decoction, taken once in the morning and once in the evening. It is simple and convenient to use, suitable for long-term use by patients of all ages, and helps to improve patient compliance.

[0042] Broad application prospects: Qinglin Formula is not only suitable for chronic prostatitis caused by qi stagnation and blood stasis, and damp-heat accumulation, but also for other types of chronic prostatitis. Its unique efficacy advantages and safety make it a potential routine and long-term medication for the prevention and treatment of chronic prostatitis, and it may also have potential therapeutic effects on other urinary system diseases.

[0043] In conclusion, Qinglin Formula demonstrates significant advantages in improving clinical symptoms, regulating TCM syndromes, controlling inflammation, improving urinary function, and enhancing quality of life, while also exhibiting good safety and patient compliance. These comprehensive technical effects make Qinglin Formula an ideal choice for treating chronic prostatitis, with broad prospects for clinical application.

[0044] A large number of technical features are described in the specification of the present application, which are distributed in various technical solutions. If all possible combinations of technical features (i.e. technical solutions) of the present application are listed, the specification will be too long. In order to avoid this problem, each technical feature disclosed in the above summary of the application, each technical feature disclosed in the following embodiments and examples can be freely combined to form various new technical solutions (which are considered to have been described in the specification), unless such combination of technical features is technically infeasible. For example, features A+B+C are disclosed in one example, features A+B+D+E are disclosed in another example, features C and D are equivalent technical means that play the same role, and can only be used at the same time, and feature E can be combined with feature C technically. Therefore, the solution of A+B+C+D should not be considered to have been described because it is technically infeasible, and the solution of A+B+C+E should be considered to have been described. DETAILED DESCRIPTION

[0045] In the following description, many technical details are presented to help the reader better understand the present application. However, those of ordinary skill in the art can understand that the technical solutions claimed by the present application can be implemented even without these technical details and based on various changes and modifications of the following embodiments.

[0046] Explanation of some concepts:

[0047] Chronic prostatitis: refers to chronic inflammation of the prostate tissue caused by various causes, and is one of the common urogenital diseases in men. Patients may have symptoms such as frequent urination, urgency, pain, burning sensation in the urethra, residual dribbling, pain, distension or discomfort in the scrotum, testicles, lower abdomen, perineum, waist and sacrum, etc.

[0048] Qi stagnation and blood stasis: one of the pathogenesis theories in traditional Chinese medicine, refers to the pathological state of blood stasis caused by the stagnation of Qi movement, leading to blood circulation disorder. In chronic prostatitis, the main symptoms are distending pain in the lower abdomen and perineum, and fixed pain.

[0049] Damp-heat accumulation: one of the pathogenesis theories in traditional Chinese medicine, refers to the pathological state of dampness and heat accumulating in the body and being difficult to dissipate. In chronic prostatitis, the main symptoms are frequent urination, urgency, pain, burning sensation in the urine, red tongue, yellow and greasy fur, etc.

[0050] Promoting blood circulation to remove blood stasis: one of the treatment methods in traditional Chinese medicine, refers to promoting blood circulation and eliminating stagnant blood through drugs or other therapies to achieve the treatment purpose.

[0051] Clearing heat and promoting diuresis: one of the treatment methods in traditional Chinese medicine, refers to clearing heat and promoting diuresis through drugs or other therapies to achieve the treatment purpose.

[0052] Tonglin: A traditional Chinese medical treatment method, specifically for unblocking the urinary tract, used to treat symptoms such as difficulty urinating.

[0053] Jun Chen Za Shi: One of the principles of traditional Chinese medicine formula, referring to the different roles and positions of various herbs in a prescription. The monarch herb is the main therapeutic drug, the ministerial herb assists the monarch herb to enhance efficacy, the auxiliary herb assists the monarch and ministerial herbs in treatment or solves the combined symptoms, and the guide herb adjusts the other herbs.

[0054] Water Decoction: A common method of decocting traditional Chinese medicines, which involves boiling medicinal materials in water to extract active ingredients.

[0055] Pericarpium Citri Reticulatae Viride: The unripe fruit of the citrus plant, belonging to the Rutaceae family. It is pungent and bitter in nature, and warm in property. It has the traditional functions of regulating qi, soothing liver, and resolving accumulation. It is commonly used to treat chest and abdominal distension, food retention, and other symptoms.

[0056] Fructus Meliae Cavaleriei: The dried mature fruit of the Melia Cavaleriei, belonging to the Meliaceae family. It is bitter and pungent in nature, and cold in property. It is traditionally believed to have the functions of soothing the liver, resolving stagnation, and relieving pain. It is commonly used to treat liver and stomach qi pain, and hernia pain.

[0057] Lindera Aggregata: The dried root and rhizome of the Lindera Aggregata, belonging to the Lauraceae family. It is pungent and warm in nature. It is traditionally believed to have the functions of regulating qi and relieving pain, and warming the kidney and dispelling cold. It is commonly used to treat abdominal pain and stomach pain caused by cold and qi stagnation.

[0058] Angelica Dahurica: The dried root of Angelica Dahurica, belonging to the Apiaceae family. It is pungent and warm in nature. Its traditional functions include relieving the exterior and dispelling cold, unblocking the nasal passages, and eliminating dampness and relieving pain. It is commonly used to treat headaches, nasal congestion, and facial pain.

[0059] Lycopi Herba: The dried aerial parts of Lycopi Herba, belonging to the Asteraceae family. It is bitter and pungent in nature, and slightly warm. It is traditionally believed to have the functions of promoting blood circulation and regulating menstruation, and promoting water excretion and resolving swelling. It is commonly used to treat menstrual disorders and abdominal pain, as well as edema.

[0060] Herba Inulae: The dried whole plant of Inula japonica, belonging to the Asteraceae family. It is bitter and slightly cold in nature. It is traditionally believed to have the functions of clearing heat and resolving toxins, and resolving abscesses and dissolving nodules. It is commonly used to treat abscesses, traumatic injuries, and other symptoms.

[0061] Olibanum: The resin of the Boswellia sacra, belonging to the Burseraceae family. It is pungent and bitter in nature, and warm in property. Its traditional functions include promoting blood circulation and relieving pain, and resolving swelling and promoting tissue regeneration. It is commonly used to treat traumatic injuries and arthralgia.

[0062] Myrrh: The resin of the Commiphora myrrha, belonging to the Burseraceae family. It is bitter and neutral in nature. It is traditionally believed to have the functions of promoting blood circulation and resolving stasis, and resolving swelling and relieving pain. It is commonly used to treat traumatic injuries and arthralgia.

[0063] Rhizoma Corydalis: The dried tuber of Corydalis yanhusuo, belonging to the Papaveraceae family. It is pungent and bitter in nature, and warm in property. It is traditionally believed to have the functions of promoting blood circulation, regulating qi, and relieving pain. It is commonly used to treat chest and abdominal pain.

[0064] Caulis Spatholobi: The dried stem of Spatholobus suberectus, a legume. It is sweet and warm in nature. Traditional uses include tonifying blood and activating blood, relaxing sinews and unblocking meridians. It is commonly used for symptoms such as physical weakness, soreness in the waist and knees, etc.

[0065] Herba Lophatheri: The dried aerial parts of Lophatherum gracile, a member of the Asteraceae family. It is bitter and acrid, with a slight coldness. It is traditionally believed to have the effects of clearing heat and resolving toxins, promoting blood flow and relieving pain. It is commonly used for symptoms such as contusions and injuries, abscesses, etc.

[0066] Seed of Falsesolmsia Hedinii: The dried mature seeds of Falsesolmsia hedinii, a member of the Caryophyllaceae family. It is sweet and neutral in nature. It is traditionally believed to have the effects of unblocking blood vessels and promoting fetal movement. It is commonly used for symptoms such as amenorrhea and dysmenorrhea, etc.

[0067] Radix Curcumae: The dried rhizome of Curcuma zedoaria, a member of the Zingiberaceae family. It is acrid and bitter, with a cold nature. Traditional uses include activating blood and relieving pain, moving qi and resolving stagnation, clearing the heart and cooling the blood. It is commonly used for symptoms such as chest and hypochondriac pain, amenorrhea, etc.

[0068] Fructus Foeniculi: The dried mature fruit of Foeniculum vulgare, a member of the Apiaceae family. It is acrid and warm in nature. It is traditionally believed to have the effects of warming the middle and dispelling cold, regulating qi and relieving pain. It is commonly used for symptoms such as cold pain in the abdomen, lumbago, etc.

[0069] The present application provides a traditional Chinese medicine composition for treating chronic prostatitis, as well as its preparation and application. The traditional Chinese medicine composition is composed of the following raw materials in parts by mass: 5-15 parts of pericarpium citri reticulatae viride, 5-15 parts of fructus meliae toosendan, 5-15 parts of linderae, 5-15 parts of radix angelicae dahuricae, 10-20 parts of lycopi, 10-20 parts of herba patriniae, 4-8 parts of olibanum, 4-8 parts of myrrh, 5-15 parts of rhizoma corydalis, 10-20 parts of caulis spatholobi, 5-15 parts of herba lophatheri, 10-20 parts of seed of falsesolmsia hedinii, 5-15 parts of radix curcumae, and 4-8 parts of fructus foeniculi.

[0070] The traditional Chinese medicine composition is particularly suitable for treating chronic prostatitis of the type of qi stagnation and blood stasis and / or damp-heat accumulation. In a preferred embodiment, the specific proportions of the composition are as follows: pericarpium citri reticulatae viride 10 parts, fructus meliae toosendan 10 parts, linderae 10 parts, radix angelicae dahuricae 10 parts, lycopi 15 parts, herba patriniae 15 parts, olibanum 6 parts, myrrh 6 parts, rhizoma corydalis 10 parts, caulis spatholobi 15 parts, herba lophatheri 10 parts, seed of falsesolmsia hedinii 15 parts, radix curcumae 10 parts, and fructus foeniculi 6 parts.

[0071] The traditional Chinese medicine composition of the present application can be combined with pharmaceutically acceptable excipients to prepare various dosage forms of traditional Chinese medicine preparations, including but not limited to decoctions, pills, tablets, granules, powders, pastes, or capsules.

[0072] In terms of preparation method, the present application provides an optional preparation method, i.e., mixing and extracting the raw materials to obtain the traditional Chinese medicine preparation. For decoctions, the specific preparation method includes: washing the traditional Chinese medicine components, weighing them according to the prescription ratio, soaking for 30 minutes, decocting twice and combining the medicinal liquid. Other dosage forms can be prepared according to conventional preparation methods.

[0073] In the application aspect, the traditional Chinese medicine preparation of the present application is used for preparing a drug for treating chronic prostatitis. The recommended dosage is 1 dose per day, taken 2 times, and 2 months as a course of treatment.

[0074] The traditional Chinese medicine composition and preparation of the present application exhibit good therapeutic effect in multiple embodiments, and the specific data will be described in detail in the subsequent clinical research part.

[0075] In order to make the purpose, technical scheme and advantages of the present application more clear, the embodiments of the present application will be further described in detail below.

[0076] Example 1: Basic formula and preparation method

[0077] Ingredients and proportion

[0078] In this embodiment, the traditional Chinese medicine composition is composed of the following components with the following weight proportions:

[0079] 5-15 parts by weight of pericarpium citri reticulatae viride; 5-15 parts by weight of fructus meliae toosendan; 5-15 parts by weight of lindera aggregata; 5-15 parts by weight of radix angelicae dahuricae; 10-20 parts by weight of herba lycopi; 10-20 parts by weight of herba patriniae; 4-8 parts by weight of olibanum; 4-8 parts by weight of myrrha; 5-15 parts by weight of rhizoma corydalis; 10-20 parts by weight of caulis sargentodoxae; 5-15 parts by weight of rhizoma coptidis; 10-20 parts by weight of herba epimedii; 5-15 parts by weight of rhizoma paridis; 5-15 parts by weight of radix curcumae; and 4-8 parts by weight of fructus carum.

[0080] Alternatively, the specific proportion of the active ingredients is as follows:

[0081] 5 parts by weight of pericarpium citri reticulatae viride; 5 parts by weight of fructus meliae toosendan; 5 parts by weight of lindera aggregata; 5 parts by weight of radix angelicae dahuricae; 10 parts by weight of herba lycopi; 10 parts by weight of herba patriniae; 4 parts by weight of olibanum; 4 parts by weight of myrrha; 5 parts by weight of rhizoma corydalis; 10 parts by weight of caulis sargentodoxae; 5 parts by weight of rhizoma coptidis; 10 parts by weight of herba epimedii; 5 parts by weight of radix curcumae; and 4 parts by weight of fructus carum.

[0082] Alternatively, the specific proportion of the active ingredients is as follows:

[0083] 10 parts by weight of pericarpium citri reticulatae viride; 10 parts by weight of fructus meliae toosendan; 10 parts by weight of lindera aggregata; 10 parts by weight of radix angelicae dahuricae; 15 parts by weight of herba lycopi; 15 parts by weight of herba patriniae; 6 parts by weight of olibanum; 6 parts by weight of myrrha; 10 parts by weight of rhizoma corydalis; 15 parts by weight of caulis sargentodoxae; 10 parts by weight of rhizoma coptidis; 15 parts by weight of herba epimedii; 10 parts by weight of radix curcumae; and 6 parts by weight of fructus carum.

[0084] Alternatively, the specific proportion of the active ingredients is as follows:

[0085] 15 parts by weight of pericarpium citri reticulatae viride; 15 parts by weight of fructus meliae toosendan; 15 parts by weight of linderae radix; 15 parts by weight of radix angelicae dahuricae; 20 parts by weight of lycopi herba; 20 parts by weight of patriniae herba; 8 parts by weight of olibanum; 8 parts by weight of myrrha; 15 parts by weight of rhizoma corydalis; 20 parts by weight of caulis sargentodoxae; 15 parts by weight of rhizoma gentianae stramnioidis; 20 parts by weight of flos daturae; 15 parts by weight of radix curcumae; 8 parts by weight of cuminum.

[0086] The traditional Chinese medicine composition in the embodiment is used for treating chronic prostatitis, in particular, chronic prostatitis of the type of qi stagnation and blood stasis and / or damp-heat accumulation.

[0087] Specific preparation steps are as follows:

[0088] (1) Raw material processing

[0089] The traditional Chinese medicinal materials such as pericarpium citri reticulatae viride, fructus meliae toosendan, linderae radix, radix angelicae dahuricae, lycopi herba, patriniae herba, olibanum, myrrha, rhizoma corydalis, caulis sargentodoxae, rhizoma gentianae stramnioidis, flos daturae, radix curcumae and cuminum are selected from GAP standardized planting bases, and the properties and quality of the medicinal materials meet the requirements of the Chinese Pharmacopoeia (2020 edition). The traditional Chinese medicinal materials are cleaned and impurities are removed for standby.

[0090] (2) Weighing

[0091] Pericarpium citri reticulatae viride, fructus meliae toosendan, linderae radix, radix angelicae dahuricae, rhizoma corydalis, rhizoma gentianae stramnioidis and radix curcumae are weighed at 5-15 g each, lycopi herba, patriniae herba, caulis sargentodoxae and flos daturae are weighed at 10-20 g each, and olibanum, myrrha and cuminum are weighed at 4-8 g each. The weighing sensitivity is 0.1 g, and the weighing deviation is not more than ±1%.

[0092] (3) Soaking

[0093] The weighed traditional Chinese medicinal materials are placed in an appropriate amount of clean water and soaked for 30 minutes to allow the medicinal materials to fully absorb water.

[0094] (4) Decoction

[0095] a) First decoction: The soaked medicinal materials are poured into a decoction container together with the soaking water, and an appropriate amount of clean water is added to cover the medicinal materials. After boiling with a strong fire, the fire is changed to a weak fire, and the medicinal materials are decocted for 30 minutes.

[0096] b) Filtration: The decoction liquid is filtered while hot, and the medicinal liquid is collected.

[0097] c) Second decoction: An appropriate amount of clean water is added to the medicinal dregs, and steps a) and b) are repeated.

[0098] (5) Combine medicinal liquid

[0099] The medicinal liquids obtained by two times of decoction are combined and stirred uniformly.

[0100] (6) Concentration (optional)

[0101] According to the needs, the combined medicinal liquid can be concentrated to the required volume in a 60-70°C water bath.

[0102] (7) Sub-packing

[0103] The medicinal liquid is sub-packed into clean glass bottles or plastic bags while hot, with each portion being 200-250ml, which is one daily dose.

[0104] (8) Cooling and storage

[0105] The sub-packed medicinal liquid is naturally cooled to room temperature and labeled (with information such as the drug name, usage and dosage, preparation date, etc.).

[0106] (9) Preservation

[0107] The prepared medicinal liquid is stored in a refrigerator at 2-8°C, with a shelf life of 7 days. If long-term storage is required, the medicinal liquid can be stored frozen, with the shelf life extended to 1 month.

[0108] Usage instructions:

[0109] One daily dose is taken, with two portions in the morning and evening. The medicinal liquid is reheated to about 37°C before taking. The treatment course is 4-8 weeks, which can be adjusted according to the disease condition.

[0110] The above specific preparation steps not only ensure the stable content of effective components of traditional Chinese medicine compositions, but also significantly improve the extraction efficiency of the drug, the dissolution of active ingredients, and the stability and bioavailability of the final product through strict quality control and optimized preparation techniques (such as reasonable soaking time, sub-cooking, and temperature-controlled concentration). Compared with traditional methods, the preparation method of the present application can more effectively preserve the active ingredients in traditional Chinese medicinal materials, improve the efficacy, and have better therapeutic effect.

[0111] It is particularly worth mentioning that by precisely controlling the cooking time and temperature, the present method effectively balances the extraction of effective components of various medicinal materials, ensuring the preservation of volatile components (such as volatile oils in pericarpium citri reticulatae and cumin) and the sufficient dissolution of poorly soluble components (such as resinous substances in frankincense and myrrh). In addition, the sub-cooking method not only improves the utilization rate of medicinal materials, but also better preserves heat-sensitive components.

[0112] It should be noted that the above specific preparation steps are exemplary and are intended to describe one possible implementation. The present application is not limited to these specific steps, and any skilled person can make various improvements and changes based on the principles and technical features of the present application, using other appropriate preparation methods and technical means, such as ultrasonic-assisted extraction, microwave extraction, or modern traditional Chinese medicine preparation technology, etc. These improvements and changes should be considered as the protection scope of the present application. For example, the cooking times, times or temperatures can be adjusted according to specific needs, or techniques such as vacuum concentration can be used to further improve product quality.

[0113] Clinical application effect

[0114] The clinical efficacy and safety of the traditional Chinese medicine composition in treating chronic prostatitis were evaluated by a randomized, double-blind, placebo-controlled clinical trial method.

[0115] 4.1 Clinical trial design

[0116] (1) Subjects: 150 patients with chronic prostatitis, aged 30-65 years, with a disease duration of 1-10 years. Those with a National Institutes of Health Chronic Prostatitis Symptom Score (NIH-CPSI) of ≥ 15 were diagnosed as having chronic prostatitis.

[0117] (2) Grouping method: Patients were divided into 3 groups according to a random number table method, with 50 patients in each group. The control group (placebo), the Qianlie Shulue group (oral Qianlie Shulue capsules 0.38 g / time, 3 times a day), and the traditional Chinese medicine group (oral Qinglin Decoction, 1 dose per day, taken twice a day).

[0118] (3) Drug preparation: The traditional Chinese medicine composition was prepared into a decoction using the preferred embodiment in Example 1, with the specific proportions as follows: 10 g of pericarpium citri reticulatae viride; 10 g of fructus toosendan; 10 g of lindera; 10 g of radix angelicae dahuricae; 15 g of lycopi herba; 15 g of herba patriniae; 6 g of olibanum; 6 g of myrrha; 10 g of rhizoma corydalis; 15 g of caulis sargentodoxae; 10 g of rhizoma coptidis; 15 g of herba epimedii; 10 g of radix curcumae; and 6 g of foeniculum vulgare. The placebo was made of starch and a small amount of traditional Chinese medicine powder, similar in appearance and odor to the traditional Chinese medicine composition decoction.

[0119] (4) Administration method: The traditional Chinese medicine group took 1 dose of Qinglin Decoction per day, taken twice a day. The Qianlie Shulue group and the control group took the drugs according to the corresponding regimen. All patients took the drugs continuously for 8 weeks.

[0120] (5) Observation indexes:

[0121] a. NIH-CPSI score: used to evaluate the severity of chronic prostatitis symptoms in patients, including pain, urinary symptoms, and quality of life in three dimensions.

[0122] b. Prostatic fluid routine examination: to observe the changes in white blood cell count in prostatic fluid.

[0123] c. Maximum urinary flow rate (Qmax): urodynamic examination was used to evaluate the urinary function of patients.

[0124] d. Residual urine volume: B-ultrasound examination was used to evaluate the urinary function of patients.

[0125] e. Quality of life score: the quality of life index (QoL) was used to evaluate the overall quality of life of patients.

[0126] f. TCM syndrome score: to evaluate the improvement of TCM symptoms in patients.

[0127] g. Inflammatory markers: to detect the levels of serum C-reactive protein (CRP) and interleukin-6 (IL-6).

[0128] h. Safety indicators: to closely observe and record adverse reactions during medication, and to regularly perform blood routine, urine routine, liver and kidney function tests, etc.

[0129] 4.2 Statistical analysis

[0130] SPSS 25.0 software was used for data analysis. Measurement data was expressed as mean ± standard deviation (Mean ± SD), and one-way ANOVA was used for comparison between groups, and paired t-test was used for comparison before and after within-group. Count data was expressed as number and percentage [n (%)], and chi-square test or Fisher's exact probability method was used for comparison between groups. Rank data was analyzed by Ridit analysis. P<0.05 was considered statistically significant.

[0131] Intention-to-treat (ITT) and per-protocol set (PPS) methods were used for efficacy analysis. Missing data was filled in by last observation carried forward (LOCF) method.

[0132] To evaluate the clinical efficacy of Qinglin Decoction, the following specific analysis will be conducted:

[0133] Primary efficacy endpoint: comparison of changes in NIH-CPSI total score and dimension scores among the three groups.

[0134] Secondary efficacy endpoint: comparison of changes in prostate fluid leukocyte count, maximum urinary flow rate, residual urine volume, quality of life score, and TCM syndrome score among the three groups.

[0135] Safety analysis: comparison of adverse reaction incidence and severity among the three groups.

[0136] Subgroup analysis: subgroup analysis based on patient age, disease duration, baseline NIH-CPSI score, and other factors to explore the efficacy differences of Qinglin Decoction in different patient populations.

[0137] 4.3 Clinical trial results

[0138] Table 1. Comparison of main evaluation indicators before and after treatment in each group

[0139]

[0140]

[0141] Note: Data are expressed as mean ± SD. Improvement rate = (post-treatment value - pre-treatment value) / pre-treatment value x 100%. "-" indicates data not applicable or not measured. NIH-CPSI: National Institutes of Health Chronic Prostatitis Symptom Index; WBC: white blood cell; QoL: quality of life index; CRP: C-reactive protein; IL-6: interleukin-6.

[0142] Table 1 shows the results of the comparison of the clinical application effects, as follows:

[0143] (1) NIH-CPSI total score: After 8 weeks, the Qinglong Decoction group decreased from 24.5 ± 3.2 to 12.3 ± 2.8, the Qianlieshulue group decreased from 24.8 ± 3.1 to 14.6 ± 3.0, and the control group decreased from 24.6 ± 3.3 to 21.2 ± 3.1. The Qinglong Decoction group and the Qianlieshulue group were significantly better than the control group (P < 0.01), and the improvement rate of the Qinglong Decoction group was significantly greater than that of the Qianlieshulue group (P < 0.05).

[0144] (2) Prostatic fluid WBC count: After 8 weeks, the Qinglong Decoction group decreased from 25.3 ± 5.6 / HP to 8.2 ± 3.1 / HP, the Qianlieshulue group decreased from 24.9 ± 5.4 / HP to 11.5 ± 3.5 / HP, and the control group decreased from 25.1 ± 5.5 / HP to 22.3 ± 5.0 / HP. The Qinglong Decoction group was significantly better than the Qianlieshulue group and the control group (P < 0.01).

[0145] (3) Maximum urinary flow rate: After 8 weeks, the Qinglong Decoction group increased from 10.2 ± 2.1 ml / s to 16.8 ± 2.5 ml / s, the Qianlieshulue group increased from 10.5 ± 2.0 ml / s to 15.3 ± 2.3 ml / s, and the control group increased from 10.3 ± 2.2 ml / s to 11.2 ± 2.1 ml / s. The Qinglong Decoction group and the Qianlieshulue group were significantly better than the control group (P < 0.01), and the improvement rate of the Qinglong Decoction group was significantly greater than that of the Qianlieshulue group (P < 0.05).

[0146] (4) Residual urine volume: After 8 weeks, the Qinglong Decoction group decreased from 45.6 ± 10.2 ml to 22.3 ± 6.5 ml, the Qianlieshulue group decreased from 44.8 ± 9.8 ml to 28.5 ± 7.2 ml, and the control group decreased from 45.2 ± 10.1 ml to 41.6 ± 9.5 ml. The Qinglong Decoction group was significantly better than the Qianlieshulue group and the control group (P < 0.01).

[0147] (5) Quality of life score (QoL): After 8 weeks, the Qinglong Decoction group decreased from 4.5 ± 0.8 to 2.1 ± 0.6, the Qianlieshulue group decreased from 4.6 ± 0.7 to 2.5 ± 0.7, and the control group decreased from 4.5 ± 0.8 to 4.0 ± 0.7. The Qinglong Decoction group was significantly better than the Qianlieshulue group and the control group (P < 0.05).

[0148] (6) TCM syndrome score: After 8 weeks, the QLFS group decreased from 18.6 ± 3.2 to 8.2 ± 2.1, the Qianliehuolue group decreased from 18.4 ± 3.1 to 10.5 ± 2.5, and the control group decreased from 18.5 ± 3.3 to 16.8 ± 3.0. The QLFS group was significantly better than the Qianliehuolue group and the control group (P < 0.01).

[0149] (7) Inflammatory markers:

[0150] CRP: After 8 weeks, the QLFS group decreased from 6.8 ± 1.5 mg / L to 3.2 ± 0.9 mg / L, the Qianliehuolue group decreased from 6.7 ± 1.4 mg / L to 4.1 ± 1.1 mg / L, and the control group decreased from 6.9 ± 1.6 mg / L to 6.3 ± 1.4 mg / L. The QLFS group was significantly better than the Qianliehuolue group and the control group (P < 0.01).

[0151] IL-6: After 8 weeks, the QLFS group decreased from 8.5 ± 1.8 pg / mL to 4.1 ± 1.2 pg / mL, the Qianliehuolue group decreased from 8.3 ± 1.7 pg / mL to 5.2 ± 1.4 pg / mL, and the control group decreased from 8.4 ± 1.9 pg / mL to 7.8 ± 1.7 pg / mL. The QLFS group was significantly better than the Qianliehuolue group and the control group (P < 0.01).

[0152] (8) Safety: The incidence of adverse reactions in the QLFS group was 4%, mainly mild gastrointestinal reactions, which could be alleviated without special treatment. The incidence of adverse reactions in the Qianliehuolue group was 12%, mainly including mild dizziness, nausea, etc. The incidence of adverse reactions in the control group was 2%. The tolerance of the QLFS group was significantly better than that of the Qianliehuolue group (P < 0.05).

[0153] Comparative Example

[0154] In order to further verify the uniqueness and superiority of the QLFS in treating chronic prostatitis, we designed two adjusted comparative examples and conducted corresponding experimental studies.

[0155] Comparative Example 1

[0156] Composition:

[0157] Pericarpium Citri Reticulatae Viride 10g

[0158] Fructus Xanthii 10g

[0159] Lindera Aggregata 10g

[0160] Radix Angelicae Dahuricae 10g

[0161] Herba Euphorbiae Humifusae 15g (instead of Herba Lycopi)

[0162] Herba Patriniae 15g

[0163] Mastic 6g

[0164] Myrrh 6g

[0165] Fibrous Cucumber 10g

[0166] Salvia 15g (replaced by Caulis Spatholobi)

[0167] Herba Andrographitis 10g

[0168] Herba Plantaginis 15g (replaced by Herba Vaccariae)

[0169] Radix Anemarrhenae 10g

[0170] Herba Foeniculi 6g

[0171] Preparation Method:

[0172] According to the above proportions, each Chinese medicinal material is weighed, washed, and then soaked in water for 30 minutes. The soaked medicinal materials are placed in a decoction container, water is added to a total volume of 1000ml, and after boiling, the fire is changed to a small fire for slow decoction. Decoction is performed for 1 hour until about 500ml remains. The decoction is filtered and divided into daily doses of 2 times.

[0173] Theoretical Basis:

[0174] Comparative Example 1 retains most of the components of the Qinglin Formula, but makes the following adjustments:

[0175] Pyrrosia herb is used instead of Lycopi Herba, aiming to enhance the effect of clearing heat and detoxifying.

[0176] Salvia is used instead of Caulis Spatholobi, with the purpose of comparing the effects of different blood-activating and stasis-removing drugs.

[0177] Herba Plantaginis is used instead of Herba Vaccariae, aiming to enhance the diuretic and urinary stone-removing effects.

[0178] This formula aims to explore the influence of adjusting some drugs on the treatment effect on the basis of retaining the main characteristics of the Qinglin Formula.

[0179] Comparative Example 2

[0180] Composition:

[0181] Pericarpium Citri Reticulatae Viride 10g

[0182] Fructus Xanthoceri 10g

[0183] Linderae 10g

[0184] Phellodendri 10g (replaced by Radix Angelicae Dahuricae)

[0185] Lycopi Herba 15g

[0186] Herba Inulae 15g

[0187] Frankincense 6g

[0188] Myrrh 6g

[0189] Corydalis 10g

[0190] Caulis Spatholobi 15g

[0191] Peach Kernel 10g (instead of Rubus parvifolius)

[0192] Cowslip 15g

[0193] Turmeric 10g

[0194] Costus 6g (instead of Foeniculum vulgare)

[0195] Preparation method:

[0196] According to the above proportion, each Chinese medicinal material is weighed, washed, and then soaked in water for 30 minutes. The soaked medicinal materials are placed in a decoction container, water is added to a total volume of 1000ml, and after boiling, the fire is changed to a small fire for slow decoction. Decoction is performed for 1 hour until about 500ml remains. The decoction is filtered and divided into daily doses of 2 times.

[0197] Theoretical basis:

[0198] Comparative Example 2 also retains most of the components of the Qinglin Formula, but with the following adjustments:

[0199] Cortex Phellodendri is used instead of Radix Angelicae Dahuricae, aiming to enhance the effect of clearing heat and drying dampness.

[0200] Peach Kernel is used instead of Rubus parvifolius, with the purpose of comparing the effects of different blood-activating and stasis-removing drugs.

[0201] Costus is used instead of Foeniculum vulgare, aiming to enhance the effect of moving qi and relieving pain.

[0202] This formula aims to explore the influence of adjusting some drugs on the treatment effect on the basis of retaining the main characteristics of the Qinglin Formula, especially in terms of clearing heat and drying dampness and moving qi and relieving pain.

[0203] Comparative experiment

[0204] In order to evaluate the treatment effects of the Qinglin Formula of the present application and the two comparative examples, we conducted an 8-week clinical comparative experiment. A total of 150 patients with chronic prostatitis were randomly divided into three groups, with 50 people in each group, and were treated with the scheme of the present application (Qinglin Formula), Comparative Example 1 and Comparative Example 2, respectively. Patients took the corresponding Chinese medicinal decoction in the morning and evening every day. Before the start of the experiment, after 4 weeks of the experiment, and at the end of the experiment, the patients were evaluated by NIH-CPSI score, TCM symptom score, and routine examination of prostatic fluid and maximum urinary flow rate determination.

[0205] Experimental results:

[0206] Evaluation index The present application (qinglon recipe) Comparative example 1 Comparative example 2 NIH-CPSI score improvement rate 49.80％ 38.71％ 43.55％ TCM symptom score improvement rate 55.91％ 44.62％ 49.46％ Effective rate 58.00％ 42.00％ 48.00％ Total effective rate 96.00％ 84.00％ 88.00％ Prostatic fluid WBC count improvement rate 67.59％ 52.17％ 58.96％ Maximum urinary flow rate improvement rate 64.71％ 47.62％ 54.29％ Patient satisfaction 87.5 73.2 79.8

[0207] Analysis of Comparative Example Results:

[0208] Symptom Improvement: The Qinglong Formula significantly outperformed both comparative examples in improving NIH-CPSI scores, likely due to the unique combination of ingredients in the Qinglong Formula that more effectively alleviate pain, improve urinary symptoms, and enhance quality of life. The Qinglong Formula achieved an improvement rate of 49.80% in NIH-CPSI scores, significantly higher than the 38.71% of Comparative Example 1 and the 43.55% of Comparative Example 2.

[0209] TCM Syndrome Regulation: The Qinglong Formula was significantly more effective than both comparative examples in regulating TCM syndromes, indicating that the Qinglong Formula's formulation better aligns with the principles of TCM diagnosis and treatment. The Qinglong Formula achieved an improvement rate of 55.91% in TCM syndrome scores, while Comparative Example 1 and Comparative Example 2 achieved 44.62% and 49.46%, respectively.

[0210] Treatment Efficiency: The Qinglong Formula had both a higher significant efficiency rate (58.00%) and a higher total efficiency rate (96.00%) than both comparative examples, demonstrating the superiority of the Qinglong Formula's formulation. This may be due to the Qinglong Formula's synergistic effects in promoting blood circulation, clearing heat and dampness, and relieving qi stagnation and pain.

[0211] Anti-inflammatory Effect: The Qinglong Formula was more effective than both comparative examples in reducing prostate fluid WBC count, achieving an improvement rate of 67.59%, while Comparative Example 1 and Comparative Example 2 achieved 52.17% and 58.96%, respectively. This indicates that the Qinglong Formula has a stronger effect on controlling local inflammation in the prostate.

[0212] Urination Function Improvement: The Qinglong Formula performed best in improving maximum urinary flow rate, achieving an improvement rate of 64.71%, significantly higher than the 47.62% of Comparative Example 1 and the 54.29% of Comparative Example 2. This reflects the unique advantages of the Qinglong Formula in improving urinary function.

[0213] Patient Satisfaction: The Qinglong Formula achieved the highest patient satisfaction score (87.5 points), reflecting its comprehensive advantages in improving symptoms and quality of life. The patient satisfaction scores of Comparative Example 1 and Comparative Example 2 were 73.2 points and 79.8 points, respectively.

[0214] In summary, through comparative experiments with two comparative examples, it is fully demonstrated that the Qinglong Formula of the present application has unique properties and advantages in treating chronic prostatitis. The Qinglong Formula not only performs well in various clinical indicators, but also has obvious advantages in patient satisfaction, reflecting the innovation and scientific nature of the present application in component selection and formulation optimization.

[0215] Specifically, the advantages of the Qinglong Formula may be attributed to the following aspects:

[0216] Comprehensive therapeutic effect: Qinglong Decoction has multiple mechanisms of action, such as promoting blood circulation to remove blood stasis (e.g., Spatholobus suberectus and Corydalis), clearing heat and dampness (e.g., Lycopi and Herba Patriniae), and promoting qi and relieving pain (e.g., Pericarpium Citri Reticulatae Viride, Fructus Meliae Toosendan, and Lindsaea), to comprehensively regulate various symptoms of chronic prostatitis.

[0217] Unique drug combination: The addition of Liuji Nu and Fructus Ficicaricis in Qinglong Decoction enhances the blood-activating and stasis-removing effects of the prescription, which helps to improve local blood circulation and eliminate inflammation in the prostate.

[0218] Precise proportioning: The proportioning of each drug in Qinglong Decoction is carefully designed to achieve the best synergistic effect of each component, thereby excelling in improving symptoms, regulating TCM syndromes, and improving quality of life.

[0219] These results provide strong experimental support for the application of Qinglong Decoction in the clinical treatment of chronic prostatitis, and also highlight the innovative value of this application in the research of traditional Chinese medicine compounds.

[0220] 4.4 Results analysis

[0221] The clinical trial results and comparative example studies of the embodiments of the present application show that Qinglong Decoction has significant advantages and uniqueness in treating chronic prostatitis.

[0222] Symptom improvement: Compared with the control group and the two comparative examples, Qinglong Decoction performs the most outstandingly in improving the symptoms of chronic prostatitis. After 8 weeks of treatment, the improvement rate of NIH-CPSI score in the Qinglong Decoction group reached 49.80%, which was significantly higher than that of the control group (13.82%) and better than that of Comparative Example 1 (38.71%) and Comparative Example 2 (43.55%). This indicates that the unique formula of Qinglong Decoction is more effective in relieving pain, improving urination symptoms, and improving quality of life.

[0223] TCM syndrome regulation: Qinglong Decoction also performs excellently in regulating TCM syndromes. The improvement rate of TCM syndrome score reached 55.91%, which was significantly better than that of the control group (9.19%) and higher than that of the two comparative examples. This shows that Qinglong Decoction is more in line with the principles of TCM syndrome differentiation and treatment, and can better regulate syndromes such as qi stagnation and blood stasis, and damp-heat accumulation.

[0224] Treatment efficiency: The significant efficiency (58.00%) and total efficiency (96.00%) of Qinglong Decoction are higher than those of the control group and the two comparative examples, proving the superiority of the Qinglong Decoction formula.

[0225] Patient satisfaction: Qinglong Decoction performs outstandingly in improving patient satisfaction, with a score of 87.5, which is much higher than that of the control group and the two comparative examples. This reflects the high recognition of patients for the treatment effect of Qinglong Decoction.

[0226] Anti-inflammatory effect: In terms of prostate fluid WBC count, the improvement rate after treatment with Qinglin Formula was 67.59%, which was better than the control group (11.16%) and the two comparative examples. This indicates that Qinglin Formula has a stronger effect in controlling local inflammation of the prostate.

[0227] Improvement of urination function: Qinglin Formula significantly improved the maximum urinary flow rate of patients, with an improvement rate of 64.71%, which was better than the control group (8.74%) and the two comparative examples. This reflects the unique advantage of Qinglin Formula in improving urination function.

[0228] Safety: Qinglin Formula showed good tolerability, with an adverse reaction rate (4%) lower than the control group and Comparative Example 1, and mainly mild gastrointestinal reactions that could be alleviated without special treatment.

[0229] The excellent performance of Qinglin Formula is closely related to its unique formula. The functions of regulating qi and relieving pain of Qingpi, Chuanlianzi, and Wuyao, the effects of clearing heat and dampness of Zelan and Baijiangcao, and the functions of promoting blood circulation and removing blood stasis of Jixueteng and Yansu form a multi-target and multi-path synergistic system. This unique combination not only effectively improves local symptoms, but also regulates the overall qi and blood circulation and damp-heat state, achieving the effect of treating both symptoms and root causes.

[0230] Through comparison with the control group and the two comparative examples, the innovation and scientificity of Qinglin Formula in component selection and ratio optimization are fully demonstrated. Qinglin Formula not only significantly improves the symptoms of patients, but also effectively controls inflammation, improves urination function, and improves the quality of life of patients, opening up a new way for the TCM treatment of chronic prostatitis.

[0231] In summary, the traditional Chinese medicine composition Qinglin Formula prepared in this application has a significant therapeutic effect on chronic prostatitis caused by qi stagnation and blood stasis, damp-heat accumulation, etc., with exact curative effect, high safety, and good patient compliance. This provides an effective, safe, and easy-to-use traditional Chinese medicine preparation for the prevention and treatment of chronic prostatitis, with broad clinical application prospects.

[0232] Technical effects:

[0233] The traditional Chinese medicine composition Qinglin Formula provided by the embodiments of this application shows significant clinical effects and advantages in the treatment of chronic prostatitis. The specific technical effects are as follows:

[0234] Comprehensive improvement of clinical symptoms: Qinglin Formula can significantly improve the clinical symptoms of patients with chronic prostatitis. In the clinical trial, after 8 weeks of treatment with Qinglin Formula, the NIH-CPSI score of patients decreased from 24.5 to 12.3 on average, with an improvement rate of 49.80%, which was significantly better than the control group (13.82%) and the two comparative examples. This indicates that Qinglin Formula can more effectively relieve pain, improve urination symptoms, and improve the quality of life.

[0235] Significantly improve the treatment efficiency: Qinglin Formula shows excellent effects in the treatment of chronic prostatitis. The results of clinical trials show that after 8 weeks of treatment with Qinglin Formula, the marked efficiency rate reaches 58.00%, and the total efficiency rate is as high as 96.00%, both significantly higher than those of the control group and two comparative examples. This means that Qinglin Formula can bring obvious improvements to the vast majority of patients.

[0236] Regulate traditional Chinese medicine syndromes: Qinglin Formula can effectively improve the traditional Chinese medicine syndromes of patients with chronic prostatitis. In clinical trials, after 8 weeks of treatment with Qinglin Formula, the average traditional Chinese medicine syndrome score of patients decreased from 18.6 points to 8.2 points, and the improvement rate reached 55.91%, significantly better than those of the control group and two comparative examples. This shows that Qinglin Formula can more effectively regulate traditional Chinese medicine syndromes such as qi stagnation and blood stasis, and damp-heat accumulation.

[0237] Significantly improve patient satisfaction: By comprehensively improving clinical symptoms and traditional Chinese medicine syndromes, Qinglin Formula significantly improves the satisfaction of patients with chronic prostatitis. In clinical trials, after 8 weeks of treatment with Qinglin Formula, the satisfaction score of patients reached 87.5 points, far exceeding those of the control group and two comparative examples. This reflects the high recognition of patients for the treatment effect of Qinglin Formula.

[0238] Effectively control inflammation: Qinglin Formula shows excellent performance in controlling local inflammation of the prostate. Clinical trials show that after 8 weeks of treatment with Qinglin Formula, the WBC count in the prostatic fluid of patients decreased from 25.3 / HP to 8.2 / HP, and the improvement rate reached 67.59%, better than those of the control group and two comparative examples. This shows that Qinglin Formula can more effectively inhibit and control the inflammatory reaction of the prostate.

[0239] Improve urinary function: Qinglin Formula significantly improves the urinary function of patients. In clinical trials, after 8 weeks of treatment with Qinglin Formula, the maximum urinary flow rate of patients increased from 10.2 ml / s to 16.8 ml / s, and the improvement rate reached 64.71%, significantly better than those of the control group and two comparative examples. This reflects the unique advantage of Qinglin Formula in improving urinary function.

[0240] Good safety: In clinical trials, after 8 weeks of treatment with Qinglin Formula, only 4% of patients had mild adverse reactions, lower than those of the control group and Comparative Example 1. And these adverse reactions were mainly mild gastrointestinal reactions, which could be relieved without special treatment. This shows that Qinglin Formula has better safety and tolerance.

[0241] Multi-target synergistic effect: Qinglin Formula plays a comprehensive therapeutic role of multiple targets and multiple pathways through the unique ratio and division of labor of Qingpi, Toosendan Fruit, Lindera Root (promoting qi circulation to relieve pain), Eupatorium japonicum Thunb., Patrinia scabiosaefolia Fisch. (clearing heat and promoting diuresis), Spatholobus suberectus Dunn, Corydalis yanhusuo W. T. Wang (promoting blood circulation to remove stasis), etc. This optimized formula can not only improve the local symptoms of patients with chronic prostatitis, but also regulate the overall qi and blood circulation and damp-heat state, making the treatment more comprehensive and thorough.

[0242] Convenient to use: Qinglong Formula adopts the form of traditional decoction, which is simple and convenient to use, and has good patient compliance. It is taken once in the morning and evening, without complex operation, and is suitable for patients of all ages.

[0243] Wide application prospect: The Qinglong Formula provided by the application is not only suitable for chronic prostatitis caused by qi stagnation and blood stasis and damp-heat accumulation, but also can be used for other types of chronic prostatitis. At the same time, due to its unique efficacy advantage and safety, it can also be used as a routine drug and long-term drug for the prevention and treatment of chronic prostatitis. In addition, the use of Qinglong Formula may have potential therapeutic effects on other urinary system diseases, and has wide clinical application value.

[0244] Although the application has been fully described in the foregoing description with reference to the drawings, modifications or improvements can be made to it on the basis of the application, which will be apparent to those skilled in the art. Therefore, these modifications or improvements made on the basis of not deviating from the spirit of the application shall fall within the scope of the application claimed.

Claims

1. A traditional Chinese medicine composition for treating chronic prostatitis, characterized in that, The traditional Chinese medicine composition is composed of the following raw materials in mass fraction: 5-15 parts of pericarpium citri reticulatae viride; 5-15 parts of melia toosendan fruit; 5-15 parts of lindera aggregata; 5-15 parts of radix angelicae dahuricae; 10-20 parts of lycopus lucidus; 10-20 parts of patrinia; 4-8 parts of olibanum; 4-8 parts of myrrha; 5-15 parts of corydalis; 10-20 parts of caulis taxilli; 5-15 parts of gentiana; 10-20 parts of fumaria; 5-15 parts of radix curcumae; 4-8 parts of cuminum cyminum.

2. The traditional Chinese medicine composition of claim 1, characterized in that, The traditional Chinese medicine composition is used for treating chronic prostatitis of qi stagnation and blood stasis and / or damp-heat accumulation.

3. The traditional Chinese medicine composition of claim 1, wherein, The traditional Chinese medicine composition is composed of the following raw materials in mass fraction: Pericarpium citri reticulatae viride 10 parts, melia toosendan fruit 10 parts, lindera aggregata 10 parts, radix angelicae dahuricae 10 parts, lycopus lucidus 15 parts, patrinia 15 parts, olibanum 6 parts, myrrha 6 parts, corydalis 10 parts, caulis taxilli 15 parts, gentiana 10 parts, fumaria 15 parts, radix curcumae 10 parts, and cuminum cyminum 6 parts.

4. The use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicine for treating chronic prostatitis of qi stagnation and blood stasis and / or damp-heat accumulation.

5. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine composition of claim 1 and pharmaceutically acceptable adjuvants.

6. The traditional Chinese medicine preparation of claim 5, characterized in that, The dosage form of the traditional Chinese medicine preparation is decoction, pill, tablet, granule, powder, paste or capsule.

7. A method for preparing the traditional Chinese medicine preparation for treating chronic prostatitis according to any one of claims 5-6, characterized in that, Comprising: The raw materials are mixed and extracted to obtain the traditional Chinese medicine preparation.

8. The method for preparing the traditional Chinese medicine preparation for treating chronic prostatitis as described in claim 7, characterized in that, When the traditional Chinese medicine preparation is decoction, the preparation method comprises: The traditional Chinese medicine components are cleaned; The traditional Chinese medicine components are weighed according to the prescription proportion; The weighed traditional Chinese medicine components are added into a proper amount of water and soaked for 30 minutes; The soaked medicinal materials are transferred into a decocting container and added with water to immerse the medicinal materials; After boiling, the fire is changed to a low fire for 30 minutes, and the medicinal liquid is filtered out; Water is added for the second time of decocting, and the medicinal liquid is filtered out; The medicinal liquids from the two times of decocting are combined.

9. The use of the traditional Chinese medicine preparation of claim 5 in the preparation of a medicine for treating chronic prostatitis.

10. Use according to claim 9, wherein: The dosage of the traditional Chinese medicine preparation is 1 dose per day, taken twice a day, and 2 months as a treatment course.

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