A traditional Chinese medicine preparation for treating chronic prostatitis

Abstract

This invention provides a traditional Chinese medicine preparation for treating chronic prostatitis, belonging to the field of traditional Chinese medicine pharmaceutical technology. The preparation comprises *Solanum nigrum*, *Hypericum perforatum*, *Dioscorea hypoglauca*, *Sparganium stoloniferum*, *Litsea cubeba*, *Malva verticillata*, *Polyporus umbellatus*, *Echinops latifolius*, *Ipomoea quamoclit*, *Eupatorium fortunei*, *Eupatorium fortunei*, *Ligustrum lucidum*, *Broussonetia papyrifera*, *Ophiopogon japonicus*, *Polygonum multiflorum*, *Hemerocallis fulva*, and *Glycyrrhiza uralensis*. This preparation possesses the effects of clearing heat and dampness, promoting blood circulation and removing blood stasis, nourishing yin and calming the mind, and tonifying the liver and kidneys. The preparation exhibits a significant therapeutic effect on CNP rats, effectively reducing prostate pathological damage and inflammatory response. Furthermore, it demonstrates good therapeutic effects in alleviating clinical symptoms and inflammation such as pain, urinary frequency, urgency, and difficulty urinating, showing a high overall effective rate for treating chronic prostatitis. This invention provides a new treatment option for chronic prostatitis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine pharmaceutical technology, specifically to a traditional Chinese medicine preparation for treating chronic prostatitis. Background Technology

[0002] Chronic prostatitis (CP) refers to a condition in which the prostate gland, under the influence of certain pathogenic factors such as infection or other precipitating factors, often presents with a series of urinary changes, such as urinary frequency, urgency, hesitancy, and difficulty urinating, along with urethral discharge and pain symptoms such as perineal and lower abdominal discomfort, and sexual dysfunction. The global incidence rate of this disease is approximately 2.2%–16.0%. CP not only affects the patient's physiology and imposes an economic burden, but also places a certain psychological burden on the patient, reducing their quality of life and happiness index.

[0003] Western medicine considers the etiology and pathogenesis of chronic pulmonary angina (CP) to be unclear, but it may be related to pathogenic microorganism infection, abnormal urination function, abnormal immune response, and neuroendocrine factors. Current Western medical treatment for CP mainly involves medication, psychological intervention, and physical therapy. While these methods can alleviate clinical symptoms in the short term, they are difficult to fundamentally stop the progression of the disease due to high recurrence rates and numerous adverse reactions. Therefore, developing more effective, safe, and stable drugs and methods for the prevention and treatment of CP has significant application value and social significance in enriching the clinical treatment approaches for CP.

[0004] Traditional Chinese medicine (TCM) categorizes prostatitis (CP) into categories such as "seminal turbidity" and "leukorrhea," with syndrome types including: heat-toxin accumulation, damp-heat accumulation, damp-heat descending, qi stagnation and blood stasis, liver qi stagnation, kidney yin deficiency, and kidney yang deficiency. The concepts of "dampness, heat, stasis, stagnation, and deficiency" permeate different stages of prostatitis, with "damp-heat accumulation" and "qi stagnation and blood stasis" being key pathogenesis mechanisms. Modern research indicates that TCM treatment for prostatitis not only follows traditional TCM theory but also exerts anti-inflammatory and analgesic effects through modern pharmacological mechanisms such as regulating immune responses and inhibiting the expression of inflammatory cytokines. Increasingly, TCM is being proven effective in treating CP, and its multi-target, multi-stage, and multi-level characteristics are gradually becoming a research hotspot. Summary of the Invention

[0005] (a) Technical problems to be solved

[0006] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine preparation for treating chronic prostatitis, which has the effects of clearing heat and dampness, promoting blood circulation and removing blood stasis, nourishing yin and calming the mind.

[0007] (II) Technical Solution

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] This invention provides a traditional Chinese medicine preparation for treating chronic prostatitis, which is made from the following raw materials in parts by weight: 5-20 parts of Solanum nigrum, 5-20 parts of St. John's wort, 5-20 parts of Dioscorea hypoglauca, 5-20 parts of Sparganium stoloniferum, 5-20 parts of Litchi chinensis, 5-20 parts of Malva verticillata, 5-20 parts of Polyporus umbellatus, 5-20 parts of Echinops latifolius, 5-20 parts of Prunella vulgaris, 5-20 parts of Euphorbia hirta, 5-20 parts of Euphorbia humifusa, 5-20 parts of Ligustrum lucidum, 5-20 parts of Broussonetia papyrifera, 5-20 parts of Ophiopogon japonicus, 5-20 parts of Polygonum multiflorum, 3-15 parts of Hemerocallis fulva, and 5-20 parts of Glycyrrhiza uralensis.

[0010] Furthermore, the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 5-15 parts of Solanum nigrum, 10-20 parts of St. John's wort, 5-15 parts of Dioscorea hypoglauca, 5-15 parts of Sparganium stoloniferum, 5-15 parts of Litchi chinensis, 5-15 parts of Malva verticillata, 5-15 parts of Polyporus umbellatus, 5-15 parts of Echinops latifolius, 5-15 parts of Prunella vulgaris, 5-15 parts of Eupolyphaga sinensis, 5-15 parts of Eupolyphaga sinensis, 5-15 parts of Ligustrum lucidum, 5-15 parts of Broussonetia papyrifera, 5-15 parts of Ophiopogon japonicus, 5-15 parts of Polygonum multiflorum, 3-10 parts of Hemerocallis fulva, and 5-15 parts of Glycyrrhiza uralensis.

[0011] Furthermore, the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 9 parts of black nightshade, 14 parts of St. John's wort, 12 parts of Dioscorea hypoglauca, 9 parts of Sparganium stoloniferum, 9 parts of Litchi chinensis, 9 parts of Malva verticillata, 12 parts of Polyporus umbellatus, 9 parts of Echinops latifolius, 9 parts of Smilax china, 9 parts of Eupolyphaga sinensis, 9 parts of Ligustrum lucidum, 9 parts of Broussonetia papyrifera, 9 parts of Ophiopogon japonicus, 9 parts of Polygonum multiflorum, 6 parts of Hemerocallis fulva, and 9 parts of Glycyrrhiza uralensis.

[0012] The traditional Chinese medicine preparation provided by this invention is used to prepare a drug for treating chronic prostatitis. The drug is made from the above-mentioned parts by weight of traditional Chinese medicine as raw materials, prepared according to conventional methods, and supplemented with medically acceptable excipients to produce granules, powders, decoctions, oral liquids, tablets, capsules, pills, ointments, and freeze-dried powders.

[0013] The pharmacological effects of each component in the traditional Chinese medicine preparation of this invention are as follows:

[0014] Black nightshade: The whole herb or fruit of black nightshade (Solanum nigrum), a plant of the Solanaceae family. It is cold in nature, bitter and slightly sweet in taste, and enters the lung and bladder meridians. It has the effects of clearing heat and detoxifying, promoting diuresis and reducing swelling, cooling blood and stopping bleeding. It is mainly used to treat boils, carbuncles, erysipelas, sprains and strains, chronic bronchitis, acute nephritis and other symptoms.

[0015] Hypericum perforatum L. (family Clusiaceae) is derived from the dried aerial parts of the plant. It is cold in nature, pungent in taste, and enters the liver meridian. It has the effects of soothing the liver and relieving depression, clearing heat and promoting diuresis, reducing swelling and promoting lactation. It is used to treat liver qi stagnation, emotional distress, chest tightness, joint swelling and pain, mastitis, and insufficient lactation.

[0016] Dioscorea: The dried rhizome of Dioscorea septemloba Thunbt and Dioscorea hypoglauca Palibin, both belonging to the Dioscoreaceae family; bitter in taste, neutral in nature, and enters the kidney and stomach meridians; it has the effects of promoting diuresis and removing turbidity, dispelling wind and relieving numbness; it is used for chyluria, leukorrhea, excessive vaginal discharge, rheumatic pain, joint stiffness, and lower back and knee pain.

[0017] Sparganium stolonierum, Buch.-Ham., is the dried tuber of the plant Sparganium stolonierum, Buch.-Ham., belonging to the family Sparganaceae. It has a pungent and bitter taste, is neutral in nature, and enters the liver and spleen meridians. It has the effects of breaking up blood stasis, promoting qi circulation, eliminating stagnation, and relieving pain. It is used for abdominal masses, dysmenorrhea, amenorrhea due to blood stasis, chest pain, and abdominal distension due to food stagnation.

[0018] Salvia plebeia R.Br., also known as toad grass or snow-seeing grass, is a plant belonging to the genus Salvia in the Lamiaceae family. It is bitter, pungent, and cool in nature, and enters the lung, stomach, and liver meridians. It has the effects of clearing heat and detoxifying, promoting diuresis and reducing swelling, cooling blood and stopping bleeding. It is often used for symptoms such as cough due to lung heat, sore throat, damp-heat jaundice, and traumatic injuries.

[0019] Malva verticillata seeds: These are the fruits of Malva verticillata L. and Malva vacrispa L., belonging to the Malvaceae family. They are sweet in taste and cold in nature, and enter the large intestine, small intestine, and bladder meridians. They have the effects of promoting urination and relieving strangury, lubricating the intestines and relieving constipation, and promoting lactation. They are commonly used for gonorrhea, edema, constipation, and insufficient lactation.

[0020] Polyporus umbellatus: The dried sclerotium of the fungus Polyporus umbellatus of the Polyporaceae family. It is sweet, bland and neutral in nature, and enters the kidney and bladder meridians. It has the effects of promoting diuresis and reducing swelling, eliminating dampness and relieving fullness, and is widely used for edema, difficulty in urination and other symptoms.

[0021] Rhaponticum uniforum (L.) DC., a plant belonging to the genus Rhaponticum in the family Asteraceae, is a dried root. It is cold in nature and bitter and salty in taste, possessing the functions of clearing heat and detoxifying, reducing swelling and dissipating nodules, promoting menstruation and lactation, and relaxing muscles and tendons. It is mainly used to treat mastitis, scrofula, insufficient lactation, and damp-heat arthralgia.

[0022] Summer-No: The dried tuber of Coydalis decumbens (Thunb.) Pers., a plant of the Papaveraceae family; bitter and slightly pungent in taste, warm in nature, and enters the liver meridian; it has the effects of promoting blood circulation, relaxing muscles and tendons, and dispelling wind and dampness; it is used for stroke hemiplegia, headache, traumatic injuries, rheumatic pain, and lower back and leg pain.

[0023] Nine-fragrant insect: A traditional Chinese medicine derived from the dried body of the nine-fragrant insect (a member of the stink bug family). It is salty and warm in nature, and enters the liver, spleen, and kidney meridians. It has the effects of regulating qi and relieving pain, warming the kidneys and tonifying yang, and is often used to treat symptoms such as abdominal distension and pain, kidney deficiency and impotence, and soreness and weakness of the waist and knees.

[0024] Privet fruit: The dried, ripe fruit of the privet plant (Ligustrum lucidum) in the Oleaceae family. It is sweet, bitter, and cool in nature, and enters the liver and kidney meridians. It has the effects of nourishing the liver and kidneys, improving eyesight, and darkening hair. It is often used to treat dizziness, weakness in the waist and knees, premature graying of hair, and blurred vision caused by liver and kidney yin deficiency.

[0025] Paper mulberry fruit: The dried, ripe fruit of the paper mulberry tree (Broussonetia papyrifera), a plant of the Moraceae family. It is sweet and cold in nature, and enters the liver and kidney meridians. It has the effects of tonifying the kidney and clearing the liver, improving eyesight and promoting diuresis. It is often used for symptoms such as liver and kidney deficiency, soreness and weakness of the waist and knees, and blurred vision.

[0026] Ophiopogon japonicus: The dried tuberous root of Ophiopogon japonicus (also known as Liriope muscari), a plant of the Liliaceae family; sweet, slightly bitter, and slightly cold in taste; enters the heart, lung, and stomach meridians; has the effects of nourishing yin and promoting body fluids, moistening the lungs and clearing the heart; used for symptoms such as thirst due to deficiency of lung and stomach yin, dry cough with hemoptysis; palpitations and easy fright due to deficiency of heart yin; and heat damage to body fluids in the later stages of febrile diseases.

[0027] Fallopia multiflora (Thunb.) Harald., a plant of the Polygonaceae family, is a vine or leafy vine. It is sweet and neutral in nature, and enters the heart and liver meridians. It has the effects of nourishing the heart and calming the mind, dispelling wind and unblocking the meridians. It is often used to treat insomnia, dreaminess, blood deficiency and body pain, and rheumatic pain.

[0028] Daylily: The root and rhizome of Hemerocallis fulva (L.) L., Hemerocallis flava L., or Hemerocallis minor Mill. (Liliaceae family), also known as Forget-Me-Not Grass, Yellow Flower Vegetable, and Child-Promoting Grass; It is sweet and cool in nature, and enters the liver, spleen, and bladder meridians. It has the effects of clearing heat and dampness, cooling blood and stopping bleeding, detoxifying and reducing swelling; It is mainly used to treat jaundice, edema, gonorrhea, leukorrhea, epistaxis, hematochezia, metrorrhagia, scrofula, mastitis, and insufficient lactation.

[0029] Licorice: The dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. (all belonging to the Fabaceae family). It has a sweet taste and neutral properties, and enters the heart, lung, spleen, and stomach meridians. It tonifies the spleen and replenishes qi, clears heat and detoxifies, resolves phlegm and relieves cough, alleviates spasms and pain, and harmonizes the effects of other herbs. It is used for spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other medications.

[0030] (III) Beneficial Effects

[0031] Chronic prostatitis falls under the categories of "Lin syndrome" and "Spermatic turbidity" in Traditional Chinese Medicine (TCM). Its core pathogenesis is often characterized by damp-heat stagnation, liver and kidney deficiency, and emotional imbalance, with a complex interplay of root cause and symptoms. This invention's TCM preparation adheres to the principle of treating the root cause and addressing both symptoms simultaneously. The formula is rationally formulated, with *Solanum nigrum* clearing damp-heat, breaking up blood stasis, and promoting urination, thus eliminating damp-heat and toxic toxins. *Hypericum perforatum*, with its pungent and dispersing properties, not only assists *Solanum nigrum* in clearing damp-heat but also soothes the liver, relieves stagnation, and promotes the flow of Qi. Together, they serve as the principal herbs, one primarily clearing blood stasis and the other relieving Qi stagnation, achieving a combined treatment of Qi and blood. Dioscorea hypoglauca, Litchi chinensis, Malva verticillata, and Polyporus umbellatus work together to promote diuresis, eliminate dampness and turbidity, clear heat and detoxify, and promote urination. The principal herb, Solanum nigrum, is added to enhance the effects of clearing heat and dampness and separating clear from turbid. Sparganium stoloniferum breaks up blood stasis and promotes qi circulation, and is an essential herb for removing blood stasis. Summer jasmine invigorates blood circulation, unblocks collaterals, promotes qi circulation and relieves pain. Together, they help the principal herb disperse the stagnation of blood stasis in the meridians of the seminal vesicles, and unblock the meridians to relieve the distending pain in the perineum. Dioscorea hypoglauca, Litchi chinensis, Malva verticillata, Polyporus umbellatus, Sparganium stoloniferum, and Summer jasmine together serve as assistant herbs, and work together to clear heat, promote diuresis, disperse blood stasis, and relieve pain. The *Echinops latifolius* clears heat and detoxifies, while the *Hemerocallis fulva* clears heat, promotes diuresis, relieves depression, and dispels melancholy. It assists the principal herb in clearing heat and promoting diuresis, and also helps *Hypericum perforatum* relieve depression. *Corydalis yanhusuo* warms the kidneys, strengthens yang, regulates qi, and relieves pain; its warming properties counteract the cold nature of the herbs in the formula, and also enhance the analgesic effects of the assistant herbs *Sparganium stoloniferum* and *Summer Solstice*. *Ophiopogon japonicus*, *Ligustrum lucidum*, and *Broussonetia papyrifera* nourish yin, generate fluids, tonify the liver and kidneys, support vital energy, and prevent the clearing and diuretic herbs from damaging yin. *Polygonum multiflorum* nourishes blood, calms the mind, dispels wind, and unblocks the meridians, assisting *Hypericum perforatum*. St. John's wort and daylily calm the mind and relieve depression and irritability, effectively alleviating symptoms of emotional imbalance. Seven herbs—Leucas cephalotes, daylily, nine-fragrant insect, Ophiopogon japonicus, Ligustrum lucidum, Broussonetia papyrifera, and Polygonum multiflorum—serve as adjuvant herbs, employing both warming and cooling properties, and combining tonifying and purging effects. These herbs not only assist the principal and assistant herbs in enhancing the effects of clearing heat, dispersing blood stasis, relieving depression, and promoting diuresis, but also harmonize the overall hot and cold properties of the formula, addressing concurrent symptoms of liver and kidney deficiency and restlessness. This ensures the formula attacks pathogens without harming the body's vital energy and nourishes without causing stagnation. Finally, licorice is added as the guiding herb to harmonize the strong properties of the other herbs and strengthen the spleen and stomach. The entire formula works synergistically to clear heat and promote diuresis, invigorate blood circulation and remove blood stasis, nourish yin and calm the mind, and tonify the liver and kidneys.

[0032] The traditional Chinese medicine preparation of this invention, after intervention in CNP model rats, can significantly protect prostate tissue, reduce edema, congestion, and inflammatory cell infiltration, and significantly reduce the prostate index of model rats, effectively improving the symptoms of prostate enlargement. It also significantly reduces the levels of inflammatory factors TNF-α, IL-1β, and IL-6 in the serum and prostate tissue of model rats, and significantly reduces the levels of COX-2, PEG2, and iNOS in the prostate tissue. This traditional Chinese medicine preparation has a significant therapeutic effect on CNP rats, effectively alleviating prostate pathological damage and inflammatory responses. Furthermore, this traditional Chinese medicine preparation can effectively improve the treatment efficacy of chronic prostatitis, alleviating clinical symptoms and inflammation such as pain, urinary frequency, urgency, and difficulty urinating, providing a new treatment option for chronic prostatitis. Attached Figure Description

[0033] Figure 1The prostate organ index (A) and prostate tissue pathological score (B) of rats in each group were compared with those of the model group. *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0034] Figure 2 The serum levels of TNF-α (A), IL-1β (B), and IL-6 (C) in each group of rats were measured. Compared with the model group, *P<0.05, **P<0.01.

[0035] Figure 3 The levels of TNF-α (A), IL-1β (B), IL-6 (C), COX-2 (D), PEG2 (E), and iNOS (F) in the prostate tissue of rats in each group were compared with those in the model group. *P<0.05, **P<0.01, ***P<0.001.

[0036] Figure 4 The results show the symptom improvement time for the two groups of patients; compared with the control group, *P<0.05, **P<0.01.

[0037] Figure 5 Serum CPR (A), IL-6 (B) levels and NIH-CPSI scores (C) before and after treatment were compared between the two groups. Within each group, *P<0.05, **P<0.01 compared with before treatment; after treatment, compared with the control group... # P<0.05, ## P<0.01. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0039] Example 1

[0040] This invention provides a traditional Chinese medicine preparation for treating chronic prostatitis, which is made from the following raw materials in parts by weight: 6 parts of Solanum nigrum, 9 parts of St. John's wort, 6 parts of Dioscorea hypoglauca, 6 parts of Sparganium stoloniferum, 6 parts of Litchi chinensis, 6 parts of Malva verticillata, 6 parts of Polyporus umbellatus, 6 parts of Echinops latifolius, 6 parts of Achyranthes bidentata, 6 parts of Eupolyphaga sinensis, 6 parts of Eupolyphaga sinensis, 6 parts of Eupolyphaga sinensis, 6 parts of Eupolyphaga sinensis, 6 parts of Eupolyphaga sinensis, 3 parts of Hemerocallis fulva, and 6 parts of Glycyrrhiza uralensis.

[0041] The traditional Chinese medicine preparation provided by this invention is used to prepare a drug for treating chronic prostatitis. The drug is made from the above-mentioned parts by weight of traditional Chinese medicine as raw materials, prepared according to conventional methods, and supplemented with medically acceptable excipients to produce granules, powders, decoctions, oral liquids, tablets, capsules, pills, ointments, and freeze-dried powders.

[0042] Example 2

[0043] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight:

[0044] Black nightshade 9 parts, St. John's wort 18 parts, Dioscorea hypoglauca 12 parts, Sparganium stoloniferum 16 parts, Litsea cubeba 9 parts, Malva verticillata 12 parts, Polyporus umbellatus 16 parts, Echinops latifolius 16 parts, Achyranthes bidentata 14 parts, Inula japonica 12 parts, Ligustrum lucidum 16 parts, Broussonetia papyrifera 12 parts, Ophiopogon japonicus 16 parts, Polygonum multiflorum 16 parts, Hemerocallis fulva 9 parts, Glycyrrhiza uralensis 14 parts.

[0045] Example 3

[0046] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 6 parts of Solanum nigrum, 12 parts of St. John's wort, 6 parts of Dioscorea hypoglauca, 9 parts of Sparganium stoloniferum, 6 parts of Litchi chinensis, 9 parts of Malva verticillata, 9 parts of Polyporus umbellatus, 6 parts of Echinops latifolius, 9 parts of Smilax china, 9 parts of Eupolyphaga sinensis, 9 parts of Ligustrum lucidum, 9 parts of Broussonetia papyrifera, 9 parts of Ophiopogon japonicus, 6 parts of Polygonum multiflorum, 4 parts of Hemerocallis fulva, and 9 parts of Glycyrrhiza uralensis.

[0047] Example 4

[0048] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 12 parts of Solanum nigrum, 20 parts of St. John's wort, 12 parts of Dioscorea hypoglauca, 12 parts of Sparganium stoloniferum, 9 parts of Litchi chinensis, 12 parts of Malva verticillata, 12 parts of Polyporus umbellatus, 9 parts of Echinops latifolius, 9 parts of Achyranthes bidentata, 12 parts of Euphorbia humifusa, 12 parts of Ligustrum lucidum, 9 parts of Broussonetia papyrifera, 12 parts of Ophiopogon japonicus, 12 parts of Polygonum multiflorum, 6 parts of Hemerocallis fulva, and 12 parts of Glycyrrhiza uralensis.

[0049] Example 5

[0050] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 9 parts of Solanum nigrum, 16 parts of St. John's wort, 9 parts of Dioscorea hypoglauca, 12 parts of Sparganium stoloniferum, 9 parts of Litchi chinensis, 12 parts of Malva verticillata, 12 parts of Polyporus umbellatus, 9 parts of Echinops latifolius, 6 parts of Prunella vulgaris, 6 parts of Euphorbia hirta, 12 parts of Ligustrum lucidum, 12 parts of Broussonetia papyrifera, 12 parts of Ophiopogon japonicus, 9 parts of Polygonum multiflorum, 5 parts of Hemerocallis fulva, and 10 parts of Glycyrrhiza uralensis.

[0051] Example 6

[0052] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 9 parts of Solanum nigrum, 14 parts of St. John's wort, 12 parts of Dioscorea hypoglauca, 9 parts of Sparganium stoloniferum, 9 parts of Litchi chinensis, 9 parts of Malva verticillata, 12 parts of Polyporus umbellatus, 9 parts of Echinops latifolius, 9 parts of Smilax china, 9 parts of Eupolyphaga sinensis, 9 parts of Eupolyphaga sinensis, 9 parts of Eupolyphaga sinensis, 9 parts of Eupolyphaga sinensis, 6 parts of Hemerocallis fulva, and 9 parts of Glycyrrhiza uralensis.

[0053] Experimental Example 1

[0054] Effects of the traditional Chinese medicine preparation of this invention on a rat model of chronic prostatitis (CNP)

[0055] 1. Materials and Methods

[0056] 1.1 Animals

[0057] Fifty SPF-grade male SD rats, weighing (220±20) g, were selected. Before the experiment, they were allowed free access to water and were kept in alternating light and dark conditions for 12 hours. They were then acclimatized for one week.

[0058] 1.2 Drugs

[0059] The traditional Chinese medicine preparation of this invention is as follows: 9g of Solanum nigrum, 14g of St. John's wort, 12g of Dioscorea hypoglauca, 9g of Sparganium stoloniferum, 9g of Litchi chinensis, 9g of Malva verticillata, 12g of Polyporus umbellatus, 9g of Echinops latifolius, 9g of Achyranthes bidentata, 9g of Euphorbia pekinensis, 9g of Ligustrum lucidum, 9g of Broussonetia papyrifera, 9g of Ophiopogon japonicus, 9g of Polygonum multiflorum, 6g of Hemerocallis fulva, and 9g of Glycyrrhiza uralensis. Add 3 times the weight of water, decoct twice, collect the decoction, concentrate under reduced pressure to a crude drug content of 1g / mL, and refrigerate for later use.

[0060] Positive control drug: Prostate Comfort Capsules

[0061] 1.3 Modeling and Drug Administration

[0062] Ten rats were randomly selected from 50 rats to form a control group, while the remaining rats underwent CNP modeling. The control group received sham surgery. The CNP model was established as follows: rats were fasted for 12 hours prior to modeling but allowed free access to water. At the start of modeling, rats were anesthetized with an intraperitoneal injection of 30 mg / kg of 3% sodium pentobarbital. After the rats were completely unconscious, they were fixed, all abdominal hair was removed, and the area was disinfected. Under aseptic conditions, an incision was made at the midline of the abdomen, and the bladder was gently lifted with a cotton swab to expose the prostate attached to the lateral bladder neck. 1% carrageenan saline solution was injected into the dorsal lobes of the bladder. In the control group, an equal volume of sterile saline solution was injected into both sides. The abdominal wall muscles and skin were sutured, and the rats were returned to their cages with free access to food and drink. Rats with successful modeling were randomly divided into a model group, a positive control group, a low-dose traditional Chinese medicine group, and a high-dose traditional Chinese medicine group, with 10 rats in each group. The treatment methods for each group are detailed in Table 1.

[0063] Table 1. Grouping and drug administration methods for rats in each group.

[0064]

[0065] 1.4 Observation Indicators

[0066] 1.4.1 General Condition Observation

[0067] During the modeling and drug administration process, the mental state and hair of the rats were continuously observed.

[0068] 1.4.2 Prostate Index Measurement

[0069] On the second day after the last administration, the rats in each group were fasted for 12 hours but allowed free access to water, and their body weight was measured. The rats were then sacrificed, and the prostate tissue was dissected and weighed accurately. The prostate index was calculated as follows: prostate index = wet prostate weight / body weight × 100%.

[0070] 1.4.3 Prostate tissue pathology scoring

[0071] The prostate tissue obtained above was fixed in 10% formaldehyde solution, embedded in paraffin, sectioned, stained with hematoxylin and eosin (HE), and observed under an optical microscope. The prostate tissue was then pathologically scored, and the scoring criteria are shown in Table 2.

[0072] Table 2. Prostate tissue pathology scoring criteria

[0073]

[0074] 1.4.4 Serum Cytokine Detection

[0075] Whole blood was collected from rats sacrificed in step 1.4.2 and stored at 4°C and 12,000 r·min. -1 Centrifuge for 20 min, collect the supernatant, and detect the levels of TNF-α, IL-1β, and IL-6 in rat serum according to the ELISA kit instructions.

[0076] 1.4.5 Detection of cytokines in prostate tissue

[0077] Take the prostate tissue from section 1.4.2 and pour it into a homogenizer. Prepare a tissue homogenate under ice bath conditions. Detect the contents of TNF-α, IL-1β, IL-6, COX-2, PEG2, and iNOS in the rat prostate tissue according to the ELISA kit instructions.

[0078] 1.5 Statistical Analysis

[0079] Statistical analysis was performed using GraphPad Prism 8.0.2 software. All data are expressed as mean ± standard deviation. The results indicate that one-way ANOVA was used for intergroup samples, and LSD test was used for pairwise comparisons between groups. P < 0.05 indicates that the difference is statistically significant.

[0080] 2 Results

[0081] 2.1 General Observation

[0082] The control group rats were active, had shiny fur, and exhibited normal eating and activity levels during the experiment. The model group rats showed symptoms such as dry fur, lethargy, and decreased appetite. All treatment groups showed improvement in fur, mental state, and appetite after administration. No rats died during the experiment, indicating that the herbal preparation of this invention is safe and effective for rats.

[0083] 2.2 Effects of the herbal preparation of this invention on the prostate index and prostate tissue pathological score of CNP rats

[0084] like Figure 1 The results showed that, compared with the blank group, the prostate index of rats in the model group was significantly increased (P<0.0001), the prostate tissue structure of rats in the model group showed significant atrophy, obvious interstitial edema and congestion, and a large number of inflammatory cells infiltrated. The prostate tissue pathology score of rats in the model group was higher, indicating that the CNP rat model was successfully established. Compared with the model group, the prostate index of rats in the positive control group and the low- and high-dose traditional Chinese medicine groups was significantly decreased (P<0.05, P<0.01, P<0.001). The prostate tissue structure, interstitial edema and congestion, and inflammatory cell infiltration of rats in the positive control group and the low- and high-dose traditional Chinese medicine groups were significantly improved. The prostate tissue pathology scores of rats in the positive control group and the low- and high-dose traditional Chinese medicine groups were significantly lower than those of the model group (P<0.0001).

[0085] 2.3 Effects of the herbal preparation of this invention on the cytokine content in serum and prostate tissue of CNP rats

[0086] like Figure 2 As shown, compared with the blank group, the serum levels of inflammatory factors TNF-α, IL-1β, and IL-6 in the model group rats were significantly increased (P<0.01); compared with the model group rats, the serum levels of inflammatory factors TNF-α, IL-1β, and IL-6 in the positive control group and the low- and high-dose traditional Chinese medicine groups were significantly decreased (P<0.01).

[0087] like Figure 3 As shown, compared with the blank group, the levels of TNF-α, IL-1β, IL-6, COX-2, PEG2, and iNOS in the prostate tissue of rats in the model group were significantly increased (P<0.01, P<0.001); compared with the model group, the levels of TNF-α, IL-1β, IL-6, COX-2, PEG2, and iNOS in the prostate tissue of rats in the positive control group and the low- and high-dose traditional Chinese medicine groups were significantly decreased (P<0.05, P<0.01, P<0.001).

[0088] 3. Conclusion

[0089] The traditional Chinese medicine preparation of this invention can significantly protect prostate tissue and reduce edema, congestion and inflammatory cell infiltration in CNP model rats after intervention. At the same time, it can significantly reduce the prostate index of model rats and effectively improve the symptoms of prostate enlargement.

[0090] With the deepening of modern pharmacological research, it has been found that the pathogenesis of CNP is closely related to immunity and inflammation. Numerous studies have shown that the levels of inflammatory factors TNF-α, IL-1β, and IL-6 are significantly increased in the serum of clinical CNP patients, and the higher the levels, the more severe the damage to prostate tissue cells. The traditional Chinese medicine preparation of this invention, after intervention in CNP model rats, can significantly reduce the levels of inflammatory factors TNF-α, IL-1β, and IL-6 in the serum and prostate tissue of the model rats. COX-2 is an important rate-limiting enzyme in the synthesis of various prostaglandins. Under pathological conditions, elevated COX-2 levels lead to increased expression of its product PGE2. PGE2 can induce increased expression of iNOS, thereby increasing NO production, causing oxidative stress, and exacerbating inflammation. The traditional Chinese medicine preparation of this invention, after intervention in CNP model rats, can significantly reduce the levels of COX-2, PEG2, and iNOS in the prostate tissue of the model rats. The traditional Chinese medicine preparation of this invention has a significant anti-inflammatory effect on CNP rats.

[0091] In summary, the traditional Chinese medicine preparation of this invention has a significant therapeutic effect on CNP rats, effectively alleviating prostate pathological damage and inflammatory response in CNP rats. This traditional Chinese medicine preparation holds promise for further development and application as a novel drug for the treatment of chronic prostatitis.

[0092] Experimental Example 2

[0093] Observation on the efficacy of the traditional Chinese medicine preparation of this invention in the treatment of chronic prostatitis

[0094] 1. Materials and Methods

[0095] 1.1 General Information

[0096] A total of 144 patients with chronic prostatitis who received treatment at our hospital from June 2024 to September 2025 were selected and randomly divided into two groups using a random number table: an observation group (n=72) and a control group (n=72). The mean age of the observation group was (56.74±8.15) years, and the mean duration of disease was (16.98±5.06) months; the mean age of the control group was (57.41±9.01) years, and the mean duration of disease was (16.29±4.88) months. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0097] 1.2 Inclusion and Exclusion Criteria

[0098] 1.2.1 Inclusion Criteria

[0099] All enrolled patients met the criteria of the "Guidelines for the Diagnosis and Treatment of Chronic Prostatitis" and had varying degrees of symptoms such as urinary frequency, urgency, and difficulty urinating; their ages ranged from 45 to 70 years; and the patients and their families provided informed consent and signed relevant documents.

[0100] 1.2.2 Exclusion Criteria

[0101] (1) Patients with acute prostatitis or other types of chronic prostatitis; (2) Patients with cystitis, seminal vesiculitis, epididymitis, irritable bowel syndrome, etc. that may cause similar symptoms; (3) Patients with benign prostatic hyperplasia, prostate cancer, prostate stones, or pelvic floor muscle dysfunction; (4) Patients with serious primary diseases of the heart, brain, liver, kidney, or lung; (5) Patients with diseases related to the lumbar spine and hip joint; (6) Patients with mental illness; (7) Patients with allergic constitution; (8) Patients with contraindications to the use of drugs.

[0102] 1.3 Methods

[0103] The control group received oral tamsulosin hydrochloride sustained-release capsules, 0.2 mg / capsule, once daily, one capsule each time. The observation group, in addition to the treatment given to the control group, received the following herbal decoction of the present invention: Solanum nigrum 9g, Hypericum perforatum 14g, Dioscorea hypoglauca 12g, Sparganium stoloniferum 9g, Litsea cubeba 9g, Malva verticillata 9g, Polyporus umbellatus 12g, Echinops latifolius 9g, Achyranthes bidentata 9g, Eupolyphaga sinensis 9g, Eupolyphaga sinensis 9g, Ligustrum lucidum 9g, Broussonetia papyrifera 9g, Ophiopogon japonicus 9g, Polygonum multiflorum 9g, Hemerocallis fulva 6g, and Glycyrrhiza uralensis 9g. The decoction was prepared using conventional methods, with each dose yielding 400 mL, taken twice daily after meals. Both groups of patients underwent treatment for 8 weeks.

[0104] 1.4 Efficacy Criteria

[0105] Clinically cured: all symptoms and signs disappear, and the NIH-CPSI score decreases by ≥90%; Markedly effective: symptoms and signs significantly improve, and the NIH-CPSI score decreases by 60%–89%; Effective: symptoms and signs improve, and the NIH-CPSI score decreases by 30%–59%; Ineffective: no significant change in symptoms and signs, and the NIH-CPSI score is below 30%. Total effective rate = (Number of clinically cured + Markedly effective + Effective cases) / Total number of cases × 100%.

[0106] 1.5 Observation Indicators

[0107] 1.5.1 Time to Improvement of Clinical Symptoms

[0108] Record the time it takes for various clinical symptoms such as pain, urinary frequency, urinary urgency, and difficulty urinating to improve during medication, in days.

[0109] 1.5.2 Serum inflammatory factor levels

[0110] Enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of C-reactive protein (CRP) and IL-6 in two groups of patients before and after treatment.

[0111] 1.5.3 Symptoms of prostatitis

[0112] The NIH-CPSI scale was used to score the severity of prostate symptoms in the two groups of patients before and after treatment. The highest score was 43 points, and the higher the score, the more severe the symptoms.

[0113] 1.6 Safety Evaluation

[0114] During the treatment period, the occurrence of adverse reactions in both groups of patients was observed.

[0115] 1.7 Statistical Analysis

[0116] Statistical analysis was performed using GraphPad Prism 8.0.2 software. All quantitative data are expressed as mean ± standard deviation. Data expressed as n (%) were analyzed using a t-test; count data expressed as [n (%)] were analyzed using a χ² test. 2 The test was performed, and a p-value < 0.05 was used to indicate that the difference was statistically significant.

[0117] 2 Results

[0118] 2.1 Comparison of symptom improvement time between the two groups

[0119] After treatment, the improvement time of clinical symptoms such as pain, urinary frequency, urinary urgency, and difficulty urinating in the observation group was significantly shorter than that in the control group (P<0.05). The results are as follows: Figure 4 As shown.

[0120] 2.2 Comparison of inflammatory markers between the two groups

[0121] Before treatment, there were no significant differences in the levels of inflammatory factors CRP and IL-6 between the two groups (P>0.05); after treatment, the levels of inflammatory factors CRP and IL-6 in both groups were significantly lower than before treatment (P<0.01); after treatment, the levels of inflammatory factors CRP and IL-6 in the observation group were significantly lower than those in the control group (P<0.01). Results are as follows. Figure 5 As shown in AB.

[0122] 2.3 Comparison of prostatitis symptom scores between the two groups

[0123] Before treatment, there was no significant difference in NIH-CPSI scores between the two groups (P>0.05); after treatment, the NIH-CPSI scores of both groups were significantly lower than before treatment (P<0.01); after treatment, the NIH-CPSI score of the observation group was significantly lower than that of the control group (P<0.05). Results are as follows. Figure 5 As shown in C.

[0124] 2.4 Comparison of treatment efficacy between the two groups

[0125] The total effective rate of treatment in the observation group was 97.22%, while that in the control group was 88.89%. The difference between the two groups was statistically significant (P<0.01).

[0126] Table 3 Comparison of treatment effects between the two groups [n (%)]

[0127]

[0128] 2.5 Adverse Reactions

[0129] During the observation period, neither group of patients experienced adverse reactions such as vomiting, dizziness, or abdominal pain.

[0130] 3. Conclusion

[0131] In this invention, the traditional Chinese medicine preparation contains *Solanum nigrum* (black nightshade) which clears heat and dampness, breaks up blood stasis and promotes urination, thus eliminating damp-heat and toxic stasis. *Hypericum perforatum* (sturgeon tree) is pungent and dispersing, assisting *Solanum nigrum* in clearing heat and dampness, while also soothing the liver, relieving depression, and promoting the flow of qi. Together, they serve as the principal herbs, one clearing blood stasis and the other relieving qi stagnation, achieving simultaneous treatment of both qi and blood. *Dioscorea hypoglauca* (sweet sorghum), *Litsea cubeba* (lychee herb), *Malva verticillata* (malva seed), and *Polyporus umbellatus* (spleen and stomach) work together to eliminate dampness and turbidity, clear heat and detoxify, and promote urination, strengthening the effects of clearing heat and dampness and separating clear from turbidity, in addition to the principal herb *Solanum nigrum*. *Sparganium stoloniferum* (sparganium rhizome) breaks up blood stasis and promotes qi circulation, a key herb for resolving blood stasis. *Summer pepper* (a type of herb) invigorates blood circulation, unblocks meridians, promotes qi circulation, and relieves pain. Together, they assist the principal herb in dispersing blood stasis in the meridians of the seminal vesicle, unblocking meridians and relieving perineal distension and pain. *Dioscorea hypoglauca* (sweet sorghum), *Litsea cubeba* (lychee herb), *Malva verticillata* (malva seed), *Polyporus umbellatus*, *Sparganium stoloniferum*, and *Summer pepper* (a type of herb) serve as the assistant herbs, clearing heat, eliminating dampness, dis The *Echinops latifolius* clears heat and detoxifies, while the *Hemerocallis fulva* clears heat, promotes diuresis, relieves depression, and dispels melancholy. It assists the principal herb in clearing heat and promoting diuresis, and also helps *Hypericum perforatum* relieve depression. *Corydalis yanhusuo* warms the kidneys, strengthens yang, regulates qi, and relieves pain; its warming properties counteract the cold nature of the herbs in the formula, and also enhance the analgesic effects of the assistant herbs *Sparganium stoloniferum* and *Summer Solstice*. *Ophiopogon japonicus*, *Ligustrum lucidum*, and *Broussonetia papyrifera* nourish yin, generate fluids, tonify the liver and kidneys, support vital energy, and prevent the clearing and diuretic herbs from damaging yin. *Polygonum multiflorum* nourishes blood, calms the mind, dispels wind, and unblocks the meridians, assisting *Hypericum perforatum*. St. John's wort and daylily calm the mind and relieve depression and irritability, effectively alleviating symptoms of emotional imbalance. Seven herbs—Leucas cephalotes, daylily, nine-fragrant insect, Ophiopogon japonicus, Ligustrum lucidum, Broussonetia papyrifera, and Polygonum multiflorum—serve as adjuvant herbs, employing both warming and cooling properties, and combining tonifying and purging effects. These herbs not only assist the principal and assistant herbs in enhancing the effects of clearing heat, dispersing blood stasis, relieving depression, and promoting diuresis, but also harmonize the overall hot and cold properties of the formula, addressing concurrent symptoms of liver and kidney deficiency and restlessness. This ensures the formula attacks pathogens without harming the body's vital energy and nourishes without causing stagnation. Finally, licorice is added as the guiding herb to harmonize the strong properties of the other herbs and strengthen the spleen and stomach. The entire formula works synergistically to clear heat and promote diuresis, invigorate blood circulation and remove blood stasis, nourish yin and calm the mind, and tonify the liver and kidneys.

[0132] The above observations show that the overall therapeutic effect of the observation group treated with the traditional Chinese medicine preparation of this invention was significantly better than that of the control group treated with Western medicine alone (P<0.01). After treatment, the improvement time of clinical symptoms such as pain, urinary frequency, urgency, and difficulty urinating in the observation group was significantly shorter than that in the control group (P<0.05). The levels of inflammatory factors CRP and IL-6 and the NIH-CPSI score in the observation group were significantly lower than those in the control group (P<0.05, P<0.01). Furthermore, no adverse reactions occurred in the observation group, indicating that the traditional Chinese medicine preparation of this invention has good safety. The traditional Chinese medicine preparation of this invention can effectively improve the therapeutic efficacy of chronic prostatitis, alleviate the clinical symptoms of patients, and provide a new treatment option for chronic prostatitis.

[0133] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine preparation for treating chronic prostatitis, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 5-20 parts of Solanum nigrum, 5-20 parts of St. John's wort, 5-20 parts of Dioscorea hypoglauca, 5-20 parts of Sparganium stoloniferum, 5-20 parts of Litchi chinensis, 5-20 parts of Malva verticillata, 5-20 parts of Polyporus umbellatus, 5-20 parts of Echinops latifolius, 5-20 parts of Achyranthes bidentata, 5-20 parts of Eupolyphaga sinensis, 5-20 parts of Ligustrum lucidum, 5-20 parts of Broussonetia papyrifera, 5-20 parts of Ophiopogon japonicus, 5-20 parts of Polygonum multiflorum, 3-15 parts of Hemerocallis fulva, and 5-20 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine preparation for treating chronic prostatitis according to claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 5-15 parts of Solanum nigrum, 10-20 parts of St. John's wort, 5-15 parts of Dioscorea hypoglauca, 5-15 parts of Sparganium stoloniferum, 5-15 parts of Litchi chinensis, 5-15 parts of Malva verticillata, 5-15 parts of Polyporus umbellatus, 5-15 parts of Echinops latifolius, 5-15 parts of Prunella vulgaris, 5-15 parts of Euphorbia hirta, 5-15 parts of Euphorbia humifusa, 5-15 parts of Ligustrum lucidum, 5-15 parts of Broussonetia papyrifera, 5-15 parts of Ophiopogon japonicus, 5-15 parts of Polygonum multiflorum, 3-10 parts of Hemerocallis fulva, and 5-15 parts of Glycyrrhiza uralensis.

3. A traditional Chinese medicine preparation for treating chronic prostatitis according to claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 9 parts black nightshade, 14 parts St. John's wort, 12 parts Dioscorea hypoglauca, 9 parts Sparganium stoloniferum, 9 parts litchi grass, 9 parts Malva verticillata seeds, 12 parts Polyporus umbellatus, 9 parts Echinops latifolius, 9 parts Smilax china, 9 parts Euphorbia hirta, 9 parts Ligustrum lucidum, 9 parts Broussonetia papyrifera seeds, 9 parts Ophiopogon japonicus, 9 parts Polygonum multiflorum, 6 parts Hemerocallis fulva, and 9 parts Glycyrrhiza uralensis.

4. A traditional Chinese medicine preparation for treating chronic prostatitis as described in any one of claims 1 to 3, characterized in that, The traditional Chinese medicine preparations are made from the above-mentioned proportions of traditional Chinese medicine as raw materials, prepared according to conventional methods, and supplemented with medically acceptable excipients, in the form of granules, powders, decoctions, oral liquids, tablets, capsules, pills, ointments, or freeze-dried powders.

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