A traditional Chinese medicine composition for treating chronic non-bacterial prostatitis and a preparation method thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating chronic non-bacterial prostatitis and its preparation method and application.The traditional Chinese medicine composition includes bran warm Chinese yam, steamed leucomalus, alisma, cistanche, smilax glabra, sanqi head, fried radix codonopsis, fried white kidney bean and prepared rehmannia, with typical characteristics of homology of medicine and food, patient is easy to tolerate, can be taken long-term;And can improve the immune capacity of organism, kidney and yang, support and consolidate, completely relieve chronic prostatitis symptoms until radical cure.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating chronic nonbacterial prostatitis, its preparation method, and its application. Background Technology

[0002] Chronic prostatitis (CP) is a common disease in male urology, with the majority of patients suffering from chronic nonbacterial prostatitis. The main symptoms include pain in the lower abdomen and perineum, accompanied by urinary symptoms such as urinary frequency, urgency, and dysuria. Some patients also experience anxiety and insomnia. In severe cases, it can lead to sexual dysfunction. The incidence rate is 10%–15%. Chronic prostatitis is prone to recurrence and is protracted, significantly impacting patients' quality of life. Refractory chronic prostatitis, in particular, with its long course, remains a challenge in clinical treatment. The pathogenesis of CP is currently unclear, but it may be closely related to the patient's immune function.

[0003] Traditional Chinese medicine (TCM) does not have a specific disease name for "prostatitis." Based on its urethral symptoms, it categorizes prostatitis under terms such as "seminal turbidity," "urinary tract turbidity," and "leukorrhea." The *Standards for Diagnosis and Treatment of Diseases in Traditional Chinese Medicine* names prostatitis "seminal turbidity" and classifies it into two main categories: basic syndromes and complex syndromes. Basic syndromes include damp-heat accumulation, qi stagnation and blood stasis, liver qi stagnation, and kidney yang or kidney yin deficiency. Complex syndromes include damp-heat stagnation, kidney deficiency with damp-heat, spleen and kidney deficiency, cold congealing the liver meridian, damp-heat accumulation, and heat toxicity accumulation. TCM has a comprehensive understanding of chronic prostatitis, emphasizing syndrome differentiation and treatment. Its location is in the kidneys, with damp-heat, kidney deficiency, and stagnation being key pathogenic mechanisms. Kidney deficiency is considered the root cause, while damp-heat stagnation is the manifestation. The treatment principle is to clear heat and dampness, and to invigorate blood and remove blood stasis.

[0004] According to the latest research literature, the etiology of chronic prostatitis is complex and its pathogenesis is unclear. Currently, there is a lack of specific treatments for chronic prostatitis, and the condition is prone to recurrence, difficult to cure completely, and prolonged treatment leads to a decline in patients' quality of life and seriously affects their physical and mental health. Western medicine mainly uses antibiotics, anti-inflammatory analgesics, and alpha-receptor antagonists, but the treatment effects are not ideal. Traditional Chinese medicine mainly uses herbal formulas or prepared Chinese medicines for internal use, which have some therapeutic effects, but require long-term medication, which is poorly tolerated by patients and difficult to adhere to. Therefore, there is an urgent need to develop some food-grade medicinal products that are easily accepted by patients and can enhance their constitution and prolong life.

[0005] In view of this, the present invention is proposed. Summary of the Invention

[0006] The problem the invention aims to solve

[0007] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition and its preparation method for treating chronic nonbacterial prostatitis. The traditional Chinese medicine composition can not only relieve the symptoms of chronic prostatitis but also serve as a nourishing food, possessing both medicinal and edible properties.

[0008] Solution for solving the problem

[0009] To address the aforementioned technical problems, this disclosure provides the following technical solutions:

[0010] This invention provides a traditional Chinese medicine composition, characterized in that it includes bran-processed yam, steamed cornus officinalis, alisma plantago-aquatica, cistanche deserticola, smilax glabra, notoginseng root, stir-fried codonopsis pilosula, stir-fried white hyacinth bean, and prepared rehmannia glutinosa.

[0011] Further, by weight percentage, the traditional Chinese medicine composition comprises: 8-10 wt% of Dioscorea opposita, 8-10 wt% of Cornus officinalis, 8-10 wt% of Alisma plantago-aquatica, 8-10 wt% of Cistanche deserticola, 8-10 wt% of stir-fried Dolichos lablab, 8-10 wt% of Rehmannia glutinosa, 4-6 wt% of Panax notoginseng root, 12-18 wt% of stir-fried Codonopsis pilosula, and 15-25 wt% of Smilax glabra.

[0012] Further, by weight percentage, the traditional Chinese medicine composition comprises: 9.8 wt% of Dioscorea opposita, 9.8 wt% of Cornus officinalis, 9.8 wt% of Alisma plantago-aquatica, 9.8 wt% of Cistanche deserticola, 9.8 wt% of stir-fried Dolichos lablab, 9.8 wt% of Rehmannia glutinosa, 5.9 wt% of Panax notoginseng root, 15.7 wt% of stir-fried Codonopsis pilosula, and 19.6 wt% of Smilax glabra.

[0013] Furthermore, the traditional Chinese medicine composition includes 2-40g of bran-warmed yam, 2-40g of steamed cornus officinalis, 2-40g of alisma plantago-aquatica, 2-40g of cistanche deserticola, 5-80g of smilax glabra, 2-20g of notoginseng root, 4-60g of stir-fried codonopsis pilosula, 2-40g of stir-fried white hyacinth bean, and 2-40g of prepared rehmannia glutinosa.

[0014] Furthermore, the traditional Chinese medicine composition includes 5-20g of bran-warmed yam, 5-20g of steamed cornus officinalis, 5-20g of alisma plantago-aquatica, 5-20g of cistanche deserticola, 10-40g of smilax glabra, 3-12g of Panax notoginseng root, 8-32g of stir-fried codonopsis pilosula, 5-20g of stir-fried white hyacinth bean, and 5-20g of prepared rehmannia glutinosa.

[0015] Furthermore, the traditional Chinese medicine composition consists of Dioscorea opposita (wheat bran yam), Cornus officinalis (steamed), Alisma plantago-aquatica, Cistanche deserticola, Smilax glabra, Panax notoginseng root, Codonopsis pilosula (fried), Dolichos lablab (fried), and Rehmannia glutinosa (processed).

[0016] The present invention provides a method for preparing the traditional Chinese medicine composition described in any of the preceding claims, characterized in that it includes the steps of weighing, mixing, soaking in water, decocting, and filtering the various components of the traditional Chinese medicine composition.

[0017] Furthermore, the soaking in water refers to soaking in water with 3-10 times the weight equivalent of the traditional Chinese medicine composition;

[0018] Preferably, the soaking in water involves adding 5-8 times the weight equivalent of the traditional Chinese medicine composition to water.

[0019] Furthermore, the soaking time is 20-80 minutes;

[0020] Preferably, the soaking time is 30-60 minutes.

[0021] Furthermore, the simmering process includes simmering over high heat and simmering over low heat;

[0022] Preferably, the simmering process involves bringing the mixture to a boil over high heat and then simmering it over low heat for 10-40 minutes.

[0023] Preferably, the simmering process involves bringing the mixture to a boil over high heat and then simmering it over low heat for 20-30 minutes.

[0024] Furthermore, the decoction is performed 1-5 times;

[0025] Preferably, the decocting is performed 2-3 times.

[0026] Furthermore, the number of times the filtration is performed is the same as the number of times the decoction is performed;

[0027] Furthermore, the step also includes mixing the filtered filtrate.

[0028] This invention provides a traditional Chinese medicine preparation, characterized in that it comprises the traditional Chinese medicine composition as described above or the traditional Chinese medicine composition prepared according to the aforementioned preparation method.

[0029] Furthermore, the traditional Chinese medicine preparation is a decoction, granules, or oral dosage form;

[0030] Preferably, the traditional Chinese medicine preparation is an oral dosage form.

[0031] The present invention also provides a method for preparing a traditional Chinese medicine preparation as described above, characterized by comprising the following steps: subjecting the traditional Chinese medicine filtrate of the aforementioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared according to the aforementioned method to vacuum recovery and concentration to obtain the preparation.

[0032] Furthermore, the concentration of the concentrated medicinal material is 0.5–2 g / ml;

[0033] Preferably, the concentration of the concentrated medicinal material is 1g / ml.

[0034] Furthermore, the concentration process also includes steps of boiling, filtering, washing, vacuum concentration, adding preservatives, and adding water and stirring.

[0035] Furthermore, the boiling process involves adding water at a ratio of 2:1 (medicinal materials:water by mass) and boiling.

[0036] Furthermore, the filtration includes filtering after allowing the sample to stand.

[0037] Furthermore, the washing process involves washing the filter residue with water.

[0038] Furthermore, the vacuum concentration includes concentrating the washing liquid and the filtrate under reduced pressure.

[0039] Furthermore, the amount of the preservative added is 1-5%;

[0040] Preferably, the amount of preservative added is 3%.

[0041] Furthermore, the preservative is selected from one or more of phenoxyethanol, sorbic acid, potassium sorbate, sodium benzoate, or benzoic acid;

[0042] Preferably, the preservative is sodium benzoate.

[0043] Furthermore, the water addition and stirring includes adding water at a mass ratio of 1:1 after filtration and stirring until homogeneous.

[0044] Furthermore, it also includes the step of dispensing the preparation into 20ml glass bottles and sealing them under aseptic conditions.

[0045] The present invention also provides the use of the traditional Chinese medicine composition as described above, or the traditional Chinese medicine composition prepared according to the method as described above, or the traditional Chinese medicine preparation as described above, or the traditional Chinese medicine preparation prepared according to the method as described above, in the preparation of a medicament for the prevention and / or treatment of prostate-related diseases.

[0046] Furthermore, the prostate-related disease is prostatitis;

[0047] Preferably, the prostate-related disease is chronic nonbacterial prostatitis.

[0048] The effects of the invention

[0049] 1. The herbal composition of this invention contains a variety of Chinese medicinal herbs, including Dioscorea opposita, Cornus officinalis, Alisma plantago-aquatica, Cistanche deserticola, and Smilax glabra, which are also nourishing foods. Based on this, an oral Chinese medicine preparation named "Prostate Relief Oral Liquid" has been developed to relieve the symptoms of chronic prostatitis. It has the typical characteristics of being both medicine and food, is easily tolerated by patients, and can be taken for a long time. It can also improve the body's immunity, tonify the kidneys and nourish yin, strengthen the body's resistance, and completely relieve the symptoms of chronic prostatitis until it is cured.

[0050] 2. The herbal composition of the present invention is more effective in treating chronic nonbacterial prostatitis than existing products, and has a certain dose-response relationship in the prevention / treatment of nonbacterial prostatitis.

[0051] 3. The "Prostate Relief Oral Solution" developed based on the traditional Chinese medicine composition of this invention will be reasonably priced and suitable for ordinary people to consume. Moreover, chronic prostatitis is a common disease with a large patient population and broad market demand. Attached Figure Description

[0052] Figure 1 The bar chart shows the prostate index of rats in each group.

[0053] Figure 2 Line graphs showing the results of abnormal pain in the pelvic region of rats in each group on days 1, 7, 14, 21, 28 and 35 of the experiment.

[0054] Figure 3 A bar chart showing the content of the inflammatory factor IL-6 in the prostate tissue of rats in each group.

[0055] Figure 4 Bar chart showing the content of the inflammatory factor MIP-1α in the prostate tissue of rats in each group.

[0056] Figure 5 Bar chart showing the content of the inflammatory factor MIP-1β in the prostate tissue of rats in each group.

[0057] Figure 6 Bar chart showing the content of the inflammatory factor TNF-α in the prostate tissue of rats in each group.

[0058] Figure 7 Histopathological section of prostate tissue from control group rats.

[0059] Figure 8 Histopathological section of prostate tissue from rats in the model group.

[0060] Figure 9 Histopathological section of prostate tissue from rats in the Qianliekang group.

[0061] Figure 10 Histopathological section of prostate tissue from rats in the low-dose group of Qianlie Huanshu oral liquid.

[0062] Figure 11 This is a histopathological section of the prostate tissue of rats in the medium-dose group of the Prostate Relief Oral Solution.

[0063] Figure 12 Histopathological section of prostate tissue from rats in the high-dose group of Qianlie Huanshu oral liquid.

[0064] Figure 13 A bar chart showing the relative expression levels of COX-2 in the prostate tissues of rats in each group.

[0065] Figure 14 Immunoblot images of COX-2 in prostate tissue of rats in each group. Detailed Implementation

[0066] To make the technical solution and beneficial effects of the present invention more apparent and understandable, a detailed description is provided below by listing specific embodiments. The accompanying drawings are not necessarily drawn to scale, and local features may be enlarged or reduced to more clearly show the details of the local features; unless otherwise defined, the technical and scientific terms used herein have the same meanings as those in the technical field to which this application pertains.

[0067] This invention provides a traditional Chinese medicine composition, characterized in that it includes bran-processed yam, steamed cornus officinalis, alisma plantago-aquatica, cistanche deserticola, smilax glabra, notoginseng root, stir-fried codonopsis pilosula, stir-fried white hyacinth bean, and prepared rehmannia glutinosa.

[0068] In some embodiments, the traditional Chinese medicine composition comprises, by weight percentage: 8-10 wt% of Dioscorea opposita, 8-10 wt% of Cornus officinalis, 8-10 wt% of Alisma plantago-aquatica, 8-10 wt% of Cistanche deserticola, 8-10 wt% of stir-fried Dolichos lablab, 8-10 wt% of Rehmannia glutinosa, 4-6 wt% of Panax notoginseng root, 12-18 wt% of stir-fried Codonopsis pilosula, and 15-25 wt% of Smilax glabra.

[0069] In some embodiments, the traditional Chinese medicine composition comprises, by weight percentage: 9.8 wt% of Dioscorea opposita, 9.8 wt% of Cornus officinalis, 9.8 wt% of Alisma plantago-aquatica, 9.8 wt% of Cistanche deserticola, 9.8 wt% of stir-fried Dolichos lablab, 9.8 wt% of Rehmannia glutinosa, 5.9 wt% of Panax notoginseng root, 15.7 wt% of stir-fried Codonopsis pilosula, and 19.6 wt% of Smilax glabra.

[0070] In some embodiments, the traditional Chinese medicine composition includes 2-40g of bran-warmed yam, 2-40g of steamed cornus officinalis, 2-40g of alisma plantago-aquatica, 2-40g of cistanche deserticola, 5-80g of smilax glabra, 2-20g of notoginseng root, 4-60g of stir-fried codonopsis pilosula, 2-40g of stir-fried white hyacinth bean, and 2-40g of prepared rehmannia glutinosa.

[0071] In some embodiments, the traditional Chinese medicine composition includes 5-20g of bran-warmed yam, 5-20g of steamed cornus officinalis, 5-20g of alisma plantago-aquatica, 5-20g of cistanche deserticola, 10-40g of smilax glabra, 3-12g of Panax notoginseng root, 8-32g of stir-fried codonopsis pilosula, 5-20g of stir-fried white hyacinth bean, and 5-20g of prepared rehmannia glutinosa.

[0072] In some embodiments, the traditional Chinese medicine composition comprises Dioscorea opposita, Cornus officinalis, Alisma plantago-aquatica, Cistanche deserticola, Smilax glabra, Panax notoginseng root, Codonopsis pilosula (fried), Dolichos lablab (fried), and Rehmannia glutinosa (processed).

[0073] In some embodiments, the traditional Chinese medicine composition consists of 5g of bran-warmed yam, 5g of steamed cornus officinalis, 5g of alisma plantago-aquatica, 5g of cistanche deserticola, 10g of smilax glabra, 3g of notoginseng root, 8g of stir-fried codonopsis pilosula, 5g of stir-fried white hyacinth bean, and 5g of prepared rehmannia glutinosa.

[0074] In some embodiments, the traditional Chinese medicine composition consists of 10g of bran-warmed yam, 10g of steamed cornus officinalis, 10g of alisma plantago-aquatica, 10g of cistanche deserticola, 20g of smilax glabra, 6g of notoginseng root, 16g of stir-fried codonopsis pilosula, 10g of stir-fried white hyacinth bean, and 10g of prepared rehmannia glutinosa.

[0075] In some embodiments, the traditional Chinese medicine composition consists of 20g of bran-warmed yam, 20g of steamed cornus officinalis, 20g of alisma plantago-aquatica, 20g of cistanche deserticola, 40g of smilax glabra, 12g of notoginseng root, 32g of stir-fried codonopsis pilosula, 20g of stir-fried white hyacinth bean, and 20g of prepared rehmannia glutinosa.

[0076] The present invention provides a method for preparing the traditional Chinese medicine composition described in any of the preceding claims, characterized in that it includes the steps of weighing, mixing, soaking in water, decocting, and filtering the various components of the traditional Chinese medicine composition.

[0077] In some embodiments, the soaking in water involves adding 3-10 times the weight equivalent of the herbal composition in water.

[0078] In some embodiments, the soaking in water involves adding 5-8 times the weight equivalent of the herbal composition in water.

[0079] In some implementations, the soaking time is 20-80 minutes.

[0080] In some implementations, the soaking time is 30-60 minutes.

[0081] In some embodiments, the simmering includes simmering over high heat and simmering over low heat.

[0082] In some implementations, the simmering process involves bringing the water to a boil over high heat and then simmering over low heat for 10-40 minutes.

[0083] In some implementations, the simmering process involves bringing the water to a boil over high heat and then simmering it over low heat for 20-30 minutes.

[0084] In some implementations, the decocting is performed 1-5 times.

[0085] In some implementations, the decocting is performed 2-3 times.

[0086] In some implementations, the number of filtrations is the same as the number of decoctings.

[0087] In some embodiments, the step further includes mixing the filtered filtrate.

[0088] This invention provides a traditional Chinese medicine preparation, characterized in that it comprises the traditional Chinese medicine composition as described above or the traditional Chinese medicine composition prepared according to the aforementioned preparation method.

[0089] In some embodiments, the traditional Chinese medicine preparation is a decoction, granules, or oral dosage form.

[0090] In some embodiments, the traditional Chinese medicine preparation is an oral dosage form.

[0091] The present invention also provides a method for preparing a traditional Chinese medicine preparation as described above, characterized by comprising the following steps: subjecting the traditional Chinese medicine filtrate of the aforementioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared according to the aforementioned method to vacuum recovery and concentration to obtain the preparation.

[0092] In some implementation schemes, the concentration of the concentrated medicinal material is 0.5–2 g / ml.

[0093] In some implementation schemes, the concentration of the concentrated medicinal material is 1 g / ml.

[0094] In some embodiments, the concentration process further includes boiling, filtering, washing, vacuum concentration, adding preservatives, and stirring with water.

[0095] In some embodiments, the boiling is performed by adding water at a ratio of 2:1 (medicinal material:water mass ratio) and boiling.

[0096] In some implementations, the boiling time is 20 to 40 minutes.

[0097] In some implementations, the boiling time is 30 minutes.

[0098] In some implementations, the filtration includes filtering after allowing the sample to settle.

[0099] In some embodiments, the washing is the washing of the filter residue with water.

[0100] In some embodiments, the vacuum concentration includes concentrating the washings and filtrate under reduced pressure.

[0101] In some embodiments, the amount of the preservative added is 1-5%.

[0102] In some embodiments, the amount of preservative added is 3%.

[0103] In some embodiments, the preservative is selected from one or more of phenoxyethanol, sorbic acid, potassium sorbate, sodium benzoate, or benzoic acid.

[0104] In some embodiments, the preservative is sodium benzoate.

[0105] In some embodiments, the water addition and stirring includes adding water at a mass ratio of 1:1 after filtration and stirring until homogeneous.

[0106] In some embodiments, the method further includes the step of aliquoting the preparation into 20 ml glass vials and sealing them under aseptic conditions.

[0107] The present invention also provides the use of the traditional Chinese medicine composition as described above, or the traditional Chinese medicine composition prepared according to the method as described above, or the traditional Chinese medicine preparation as described above, or the traditional Chinese medicine preparation prepared according to the method as described above, in the preparation of a medicament for the prevention and / or treatment of prostate-related diseases.

[0108] In some implementations, the prostate-related disease is prostatitis.

[0109] In some implementations, the prostate-related disease is chronic nonbacterial prostatitis.

[0110] The method of the present invention will be described below through specific embodiments. It should be understood that these embodiments are used to illustrate the basic principles, main features and advantages of the present invention, and the present invention is not limited to the scope of the following embodiments. The implementation conditions used in the embodiments can be further adjusted according to specific requirements, and the implementation conditions not specified are usually the conditions in conventional experiments.

[0111] Unless otherwise specified, all reagents and materials used in the following examples are commercially available.

[0112] Example 1

[0113] A low-dose traditional Chinese medicine composition for treating chronic nonbacterial prostatitis, comprising the following ingredients:

[0114] 5g of bran-warmed yam, 5g of steamed cornus officinalis, 5g of alisma plantago-aquatica, 5g of cistanche deserticola, 10g of smilax glabra, 3g of notoginseng root, 8g of stir-fried codonopsis pilosula, 5g of stir-fried white hyacinth bean, and 5g of prepared rehmannia glutinosa.

[0115] Preparation method: Mix the above raw materials together, put them into a medicine pot, add 5-8 times the weight equivalent of water to submerge them, submerge for 60 minutes, boil over high heat until boiling, then simmer over low heat for 20 minutes, filter to obtain filtrate, add water to the residue again to submerge it, boil over high heat until boiling, then simmer over low heat for 25 minutes, filter to obtain filtrate, combine the two filtrates, mix well to obtain the final product.

[0116] Example 2

[0117] A medium-dose traditional Chinese medicine composition for treating chronic nonbacterial prostatitis, comprising the following ingredients:

[0118] 10g of bran-warmed yam, 10g of steamed cornus officinalis, 10g of alisma plantago-aquatica, 10g of cistanche deserticola, 20g of smilax glabra, 6g of notoginseng root, 16g of stir-fried codonopsis pilosula, 10g of stir-fried white hyacinth bean, and 10g of prepared rehmannia glutinosa.

[0119] Preparation method: Mix the above raw materials together, put them into a medicine pot, add 5-8 times the weight equivalent of water to submerge them, submerge for 60 minutes, boil over high heat until boiling, then simmer over low heat for 20 minutes, filter to obtain filtrate, add water to the residue again to submerge it, boil over high heat until boiling, then simmer over low heat for 25 minutes, filter to obtain filtrate, combine the two filtrates, mix well to obtain the final product.

[0120] Example 3

[0121] A high-dose traditional Chinese medicine composition for treating chronic nonbacterial prostatitis, comprising the following ingredients:

[0122] 20g of bran-warmed yam, 20g of steamed cornus officinalis, 20g of alisma plantago-aquatica, 20g of cistanche deserticola, 40g of smilax glabra, 12g of notoginseng root, 32g of stir-fried codonopsis pilosula, 20g of stir-fried white hyacinth bean, and 20g of prepared rehmannia glutinosa.

[0123] Preparation method: Mix the above raw materials together, put them into a medicine pot, add 5-8 times the weight equivalent of water to submerge them, submerge for 60 minutes, boil over high heat until boiling, then simmer over low heat for 20 minutes, filter to obtain filtrate, add water to the residue again to submerge it, boil over high heat until boiling, then simmer over low heat for 25 minutes, filter to obtain filtrate, combine the two filtrates, mix well to obtain the final product.

[0124] Example 4: Preparation of Prostate Relief Oral Solution

[0125] The herbal filtrates obtained in Examples 1 to 3 were recovered under reduced pressure and concentrated to a concentration of 1 g / ml (1 g of herb per ml of water). Water was added at a mass ratio of 2:1 and boiled for 30 minutes. The solution was allowed to stand for 24 hours, filtered, and the residue was washed with a small amount of water. The washings were added back to the filtrate, and the solution was concentrated under reduced pressure. Sodium benzoate (a preservative) was added at a mass ratio of 3% of the concentrated solution, stirred well, allowed to stand for 24 hours, filtered, and water was added at a mass ratio of 1:1. The solution was then stirred well to obtain the preparation. Under aseptic conditions, the preparation was dispensed into 20 ml glass bottles and sealed for later use.

[0126] Example 1: Effects of Prostate Relief Oral Solution on Body Weight and Prostate Index in Rats with Chronic Nonbacterial Prostatitis

[0127] I. Experimental Materials

[0128] (1) Experimental animals: SD rats, 7 to 8 weeks old, weighing 180 to 220g, SPF grade male.

[0129] (2) Drugs: Complete Freund's adjuvant (CFA), 37.5% chloral hydrate, 0.5% CMC-Na, levofloxacin solution.

[0130] II. Experimental Methods

[0131] 1. Construction of a rat model of autoimmune chronic nonbacterial prostatitis

[0132] Experimental SD rats (weighing 180–220 g, SPF grade males) were anesthetized by intraperitoneal injection with 0.8 mL / 100 g of 37.5% chloral hydrate. The control group received two subcutaneous injections of 1.0 mL of physiological saline solution at multiple points on days 0 and 7. The model group received two subcutaneous injections of 1.0 mL each of purified rat prostate protein solution and Freund's complete adjuvant (CFA) emulsion (1:1 ratio suspension) at multiple points on days 0 and 7 (0.3 mL × 2 on both upper backs and 0.2 mL each in the bilateral groin areas). On day 21, the control group received multiple subcutaneous injections of 1.0 mL of physiological saline solution; the model group received multiple subcutaneous injections of 1.0 mL each of purified rat prostate protein solution and incomplete Freund's adjuvant emulsion (1:1 ratio suspension) at multiple points (0.3 mL × 2 on both upper backs and 0.2 mL each in the bilateral groin areas). The protein content of the purified prostate protein solution from rats on days 0 and 7 was 20 mg / mL, and the protein content of the purified prostate protein solution from rats on day 21 was 40 mg / mL. A rat model of autoimmune chronic nonbacterial prostatitis was established 42 days after the first injection.

[0133] 2. Experimental Grouping

[0134] (1) Control group (6 animals): Starting from day 35 after modeling, the animals were given 0.5% CMC-Na solution by gavage once a day, with a volume of 1 mL / 100 g, for a total of 35 days.

[0135] (2) Model group (6 animals): Starting from day 35 after modeling, the animals were given 0.5% CMC-Na solution by gavage once a day, with a volume of 1 mL / 100 g, for a total of 35 days.

[0136] (3) Prostate Health Group (6 animals): Starting from day 35 after modeling, the animals were given 2 mg / mL levofloxacin solution by gavage once a day, with a single dose of 20 mg levofloxacin / kg body weight, for a total of 35 days.

[0137] (4) Low-dose group of Prostate Relief Oral Solution (6 animals): Prostate Relief Oral Solution was administered once daily by gavage starting on the 35th day after modeling, with the single dose to be determined, for a total of 35 days.

[0138] (5) Medium-dose group of Prostate Relief Oral Solution (6 animals): Prostate Relief Oral Solution was administered once daily by gavage starting on the 35th day after modeling, with the single dose to be determined, for a total of 35 days.

[0139] (6) High-dose group of Prostate Relief Oral Solution (6 animals): Prostate Relief Oral Solution was administered once daily by gavage starting on the 35th day after modeling, with the single dose to be determined, for a total of 35 days.

[0140] III. Testing Methods

[0141] The prostate index can reflect the degree of prostate inflammation. On day 35 of the experiment, after weighing the rats in each group, they were anesthetized by intraperitoneal injection of an excess of 37.5% chloral hydrate, and the prostate tissue was collected for wet weight and prostate index calculation. The body weight of the rats in the experimental groups is shown in Table 1. There was no significant difference in body weight among the groups when the sample tissue was collected.

[0142] The prostate index is calculated as follows:

[0143] Prostate Index (PI) = Prostate tissue wet weight (g) / Rat body weight (g) × 100%.

[0144] The results are as follows Figure 1 As shown, compared with the control group, the prostate index of rats in the model group increased significantly; compared with the model group, the positive control drug Qianliekang tablets did not show a significant difference in the change of prostate index, while the prostate index of the medium-dose group and the high-dose group of Qianlieshuhuan oral liquid decreased to varying degrees and showed significant differences, which were similar to the levels of the control group.

[0145] Table 1

[0146]

[0147] Example 2: Effect of Prostate Relief Oral Solution on Abnormal Pelvic Pain in Rats with Chronic Nonbacterial Prostatitis

[0148] The experimental materials and methods used in this embodiment are the same as those in Example 1.

[0149] The testing method was as follows: Abnormal pain in the pelvic region of rats was tested on days 0, 7, 14, 21, and 35 after modeling and immunization. Rats were allowed 30 minutes to acclimatize before tactile abnormal pain was tested using Von Frey filaments at forces of 0.4g, 1g, and 4g. Each filament was applied a total of 5 times, each time for 1-2 seconds, with a 2-minute interval between stimulations. The filaments were then applied in ascending order of force. Stimulation was limited to the lower abdominal region on the prostate gland, and care was taken to stimulate different areas within this region to avoid desensitization or inflammatory effects. The following three types of behavior were categorized as positive responses to filament stimulation: 1. Abdominal contraction; 2. Immediate licking or scratching of the stimulated site; 3. Jumping. The frequency of these responses was calculated as the percentage of positive responses.

[0150] The results are as follows Figure 2As shown, after treating rats with autoimmune chronic nonbacterial prostatitis with Prostate Relief Oral Solution for 35 days, the frequency of abnormal pain responses in the rats was lower than that in the model group and similar to that in the control group during the 35-day treatment period. Furthermore, during the 35-day intervention period, the model group had the highest frequency of pain responses, significantly higher than the three Prostate Relief Oral Solution groups, while the control group had the lowest frequency. The positive control group (Prostate Health Tablets) showed intervention effects on days 28 and 35, but the effects were slightly less than those in the medium- and high-dose Prostate Relief Oral Solution groups. Comparison of the three Prostate Relief Oral Solution groups revealed that the high-dose group was more effective than the low- and medium-dose groups, indicating that Prostate Relief Oral Solution has a dose-response relationship in the prevention / treatment of nonbacterial prostatitis.

[0151] Example 3: Effects of Prostate Relief Oral Solution on Cellular Inflammatory Factors in Prostatic Tissue of Rats with Chronic Nonbacterial Prostatitis

[0152] The experimental materials and methods used in this embodiment are the same as those in Example 1.

[0153] On day 35 of the experiment, rat prostate tissue was added to physiological saline at a weight-to-volume ratio of 1:2 (g:mL), homogenized, and centrifuged at 14,000 rpm for 25 min at 4℃. The supernatant was collected. The levels of cytokines TNF-α, IL-6, MIP-1α, and MIP-1β in the prostate tissue were detected according to the ELISA kit procedure.

[0154] The results of ELISA detection of TNF-α, IL-6, MIP-1α, and MIP-1β levels in prostate tissue are as follows: Figures 3 to 6 As shown in the figure, compared with the control group, the levels of TNF-α, IL-6, MIP-1α, and MIP-1β in the model group were significantly increased. Compared with the model group, the levels of inflammatory factors in each treatment group were decreased to varying degrees, showing significant statistical differences (P < 0.05). Among them, the levels of inflammatory factors TNF-α, IL-6, MIP-1α, and MIP-1β in the three groups treated with Qianlieshuhuan oral liquid were significantly lower than those in the model group, indicating that the high-dose, medium-dose, and low-dose groups of Qianlieshuhuan oral liquid had better anti-inflammatory effects than the positive control drug Qianliekang tablets group.

[0155] Example 4: Effects of Qianlie Huanshu Oral Solution on Prostate Pathological Morphology in Rats with Chronic Nonbacterial Prostatitis

[0156] The experimental materials and methods used in this embodiment are the same as those in Example 1.

[0157] On day 35 of the experiment, rat prostate tissue was washed with physiological saline and fixed in neutral tissue fixative for more than 24 hours. After fixation, paraffin sections were prepared, stained with hematoxylin and eosin (HE) according to conventional methods, and examined under a microscope. The pathological morphology of the prostate tissue in each group was analyzed and compared.

[0158] The pathological observation results of HE staining of prostate tissue from each group of rats are as follows: Figures 7 to 12 As shown, all magnifications are 100x. Section results show that in the blank control group, the prostate tissue showed intact acinar structure, full acini, and uniform pink secretions within the glandular lumen. The acinar epithelium was a single-layer structure, and there was no edema between the glands. In the model group, the prostate tissue showed atrophied acinar tissue with wrinkles, multi-layered acinar epithelium, disappearance of secretions within the glandular lumen, edema between the glands, and partial congestion. Numerous lymphocyte infiltrations were also observed. The positive control group (Qianliekang tablets) showed a lower degree of relief from glandular atrophy, but significant thickening of the acinar epithelium was still visible. In the group treated with Qianlieshuhuan oral liquid, glandular atrophy was significantly relieved, the epithelial cells were a single layer with a relatively neat arrangement, no edema was observed between the glands, and the pink secretions within the lumen were uniformly distributed. Some lymphocyte infiltration was still visible in the low-dose group, while inflammatory cell infiltration was reduced in the high-dose group.

[0159] Example 5

[0160] The experimental materials and methods used in this embodiment are the same as those in Example 1.

[0161] On day 35 of the experiment, total protein was extracted from prostate tissue of rats in each group. Protein concentration was determined by BCA. Equal amounts of protein were loaded onto the membrane, and after SDS-PAGE gel electrophoresis, the samples were transferred to PVDF membranes. The membranes were blocked with skim milk for 1 hour, and then incubated overnight at 4°C with primary antibodies (cox-2 diluted 1:1000 and β-actin diluted 1:5000). The membranes were washed 3 times with TBST, and then incubated at 37°C for 1 hour with secondary antibodies. The membranes were then developed by ECL, and images were acquired using the BioRad full-function imaging system. Optical density was analyzed using Image-J. The relative protein expression of each group was calculated using β-actin as an internal control.

[0162] The results are as follows Figures 13 to 14 As shown, COX-2 expression in the prostate tissue of rats in the model group was significantly higher than that in the control group, and COX-2 expression in the prostate tissue of the medium and high dose groups of the Prostate Relief Oral Solution was significantly lower than that in the model group.

[0163] It should be understood that the above embodiments are exemplary and are not intended to encompass all possible implementations included in the claims. Various modifications and changes can be made to the above embodiments without departing from the scope of this disclosure. Similarly, the various technical features of the above embodiments can be arbitrarily combined to form other embodiments of the present invention that may not be explicitly described. Therefore, the above embodiments only illustrate several implementations of the present invention and do not limit the scope of protection of this patent.

Claims

1. A traditional Chinese medicine composition, characterized in that, By weight percentage, the traditional Chinese medicine composition comprises 9.8 wt% of Dioscorea opposita, 9.8 wt% of Cornus officinalis, 9.8 wt% of Alisma plantago-aquatica, 9.8 wt% of Cistanche deserticola, 9.8 wt% of stir-fried Dolichos lablab, 9.8 wt% of Rehmannia glutinosa, 5.9 wt% of Panax notoginseng root, 15.7 wt% of stir-fried Codonopsis pilosula, and 19.6 wt% of Smilax glabra.

2. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition consists of 2-40g of bran-warmed yam, 2-40g of steamed cornus officinalis, 2-40g of alisma plantago-aquatica, 2-40g of cistanche deserticola, 5-80g of smilax glabra, 2-20g of notoginseng root, 4-60g of stir-fried codonopsis pilosula, 2-40g of stir-fried white hyacinth bean, and 2-40g of prepared rehmannia glutinosa.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition consists of 5-20g of bran-warmed yam, 5-20g of steamed cornus officinalis, 5-20g of alisma plantago-aquatica, 5-20g of cistanche deserticola, 10-40g of smilax glabra, 3-12g of notoginseng root, 8-32g of stir-fried codonopsis pilosula, 5-20g of stir-fried white hyacinth bean, and 5-20g of prepared rehmannia glutinosa.

4. A method for preparing a traditional Chinese medicine composition as described in any one of claims 1 to 3, characterized in that, The process includes weighing, mixing, soaking in water, decocting, and filtering the various components of the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that, The soaking in water involves adding 3-10 times the weight equivalent of the herbal composition to water.

6. The preparation method according to claim 5, characterized in that, The soaking in water involves adding 5-8 times the weight equivalent of the herbal composition to water.

7. The preparation method according to claim 4, characterized in that, The soaking time is 20-80 minutes.

8. The preparation method according to claim 7, characterized in that, The soaking time is 30-60 minutes.

9. The preparation method according to claim 4, characterized in that, The cooking process includes cooking over high heat and cooking over low heat.

10. The preparation method according to claim 9, characterized in that, The simmering process includes bringing the mixture to a boil over high heat and then simmering it over low heat for 10-40 minutes.

11. The preparation method according to claim 10, characterized in that, The simmering process includes bringing the mixture to a boil over high heat and then simmering it over low heat for 20-30 minutes.

12. The preparation method according to claim 4, characterized in that, The decoction is prepared 1-5 times.

13. The preparation method according to claim 12, characterized in that, The decoction is prepared 2-3 times.

14. The preparation method according to claim 4, characterized in that, The number of filtrations is the same as the number of decoctings.

15. The preparation method according to claim 4, characterized in that, The steps also include mixing the filtered filtrate.

16. A traditional Chinese medicine preparation, characterized in that, This includes the traditional Chinese medicine composition according to any one of claims 1-3 or the traditional Chinese medicine composition prepared by the method according to any one of claims 4-15.

17. The traditional Chinese medicine preparation according to claim 16, characterized in that, The traditional Chinese medicine preparation is an oral dosage form.

18. The traditional Chinese medicine preparation according to claim 16, characterized in that, The traditional Chinese medicine preparation is either a decoction or granules.

19. A method for preparing a traditional Chinese medicine preparation as described in claim 16, characterized in that, Includes the following steps: The traditional Chinese medicine filtrate containing any one of the traditional Chinese medicine compositions according to claims 1-3, or the traditional Chinese medicine composition prepared according to any one of claims 4-15, is subjected to vacuum recovery and concentration to obtain the preparation.

20. The preparation method according to claim 19, characterized in that, The concentration of the concentrated medicinal materials is 0.5~2g / ml.

21. The preparation method according to claim 20, characterized in that, The concentration of the concentrated medicinal materials is 1g / ml.

22. The preparation method according to claim 19, characterized in that, The concentration process also includes steps such as boiling, filtering, washing, vacuum concentration, adding preservatives, and adding water and stirring.

23. The preparation method according to claim 22, characterized in that, The boiling process involves adding water at a ratio of 2:1 (medicinal materials:water mass ratio) and boiling.

24. The preparation method according to claim 22, characterized in that, The filtration process includes filtering after allowing the sample to stand.

25. The preparation method according to claim 22, characterized in that, The washing process involves washing the filter residue with water.

26. The preparation method according to claim 22, characterized in that, The vacuum concentration includes combining the washing liquid and the filtrate and then concentrating them under reduced pressure.

27. The preparation method according to claim 22, characterized in that, The amount of the preservative added is 1-5%.

28. The preparation method according to claim 27, characterized in that, The amount of preservative added is 3%.

29. The preparation method according to claim 22, characterized in that, The preservative is selected from one or more of phenoxyethanol, sorbic acid, potassium sorbate, sodium benzoate, or benzoic acid.

30. The preparation method according to claim 29, characterized in that, The preservative is selected from sodium benzoate.

31. The preparation method according to claim 22, characterized in that, The process of adding water and stirring includes adding water at a mass ratio of 1:1 after filtration and stirring until well mixed.

32. The preparation method according to claim 22, characterized in that, It also includes the step of dispensing the preparation into 20ml glass bottles and sealing them under aseptic conditions.

33. The use of the traditional Chinese medicine composition according to any one of claims 1-3, or the traditional Chinese medicine composition prepared by the method according to any one of claims 4-15, or the traditional Chinese medicine preparation according to any one of claims 16-18, or the traditional Chinese medicine preparation prepared by the method according to any one of claims 19-32, in the preparation of a medicament for the prevention and / or treatment of prostate-related diseases.

34. The application according to claim 33, characterized in that, The prostate-related disease mentioned is prostatitis.

35. The application according to claim 33, characterized in that, The prostate-related disease mentioned is chronic nonbacterial prostatitis.

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