Traditional Chinese medicine composition for benign prostatic hyperplasia, extract and application

Abstract

The traditional Chinese medicine composition is prepared from the following raw materials: astragalus membranaceus, herba artemisiae anomalae, pollen typhae, rhizoma dioscoreae septemlobae, stiff silkworm, kelp, cinnamon, curcuma zedoary, euphorbia helioscopia, tortoise plastron and liquorice. According to the traditional Chinese medicine composition or the extract of the traditional Chinese medicine composition provided by the invention, under the guidance of a new thought of prostate meridian and collateral qi and blood differentiation, inherent physiological differences of different regions of the prostate are fully considered, pathological characteristics and pathogenesis of diseases are discriminated on the basis, and a new traditional Chinese medicine formula aiming at prostate lesions is constructed and formed; the traditional Chinese medicine formula especially aims at benign prostatic hyperplasia lesions.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound, a traditional Chinese medicine composition prepared therefrom, a preparation method and an application thereof, in particular an application for preventing or treating benign prostatic hyperplasia. Background Art

[0002] The prostate is the largest parenchymal organ among the accessory glands of the male genitalia, located between the bladder and the urogenital diaphragm. Men are inevitably affected by prostate diseases throughout their lives. At the same time, with the advent of the era of severe aging, the incidence of prostate-related diseases has increased significantly. Among them, benign prostatic hyperplasia is the most common type of lesion occurring in the prostate and is also the most common chronic progressive disease causing abnormal urination in middle-aged and elderly men. In 1968, scholars at Stanford University in the United States, McNeal, proposed the currently widely used prostate zonal theory from the dual perspectives of histology and anatomy, dividing the glandular tissue into the peripheral zone, the central zone, and the transitional zone. Since the proposal of the prostate zonal theory for more than half a century, such a fact has gradually become clear: Benign prostatic hyperplasia only occurs in the transitional zone of the prostate.

[0003] Benign prostatic hyperplasia (BPH), also known as prostate hyperplasia, is mainly manifested by the proliferation of prostatic stromal cells and epithelial cells in the transitional zone around the urethra. It is a common and frequently-occurring disease in urological clinical practice, with a relatively high incidence in elderly men. The incidence of BPH in men over 50 years old is as high as 50%, and the incidence of BPH in men over 80 years old is as high as 80%. Although BPH rarely causes death, the changes in bladder function caused by urethral compression and urine flow obstruction during the disease process, such as detrusor overactivity or decreased detrusor contractility, are accompanied by a feeling of fullness in the lower abdomen or lumbosacral pain, etc. In severe cases, it can cause secondary complications such as acute urinary retention or upper urinary tract lesions. At the same time, it is often accompanied by metabolic syndromes (Metabolic syndrome, MetS) such as hypertension and hyperlipidemia, making the existing surgical treatment and chemical drug treatment often have problems such as high recurrence rate, long medication cycle, and high side effects, seriously affecting the quality of life of middle-aged and elderly male patients. According to McNeal's zoning method, the prostate is divided into several different regions, including the periurethral glandular tissue region, the central region, the transitional zone, and the peripheral zone. According to research (see Non-Patent Document 1), benign prostatic hyperplasia is prone to occur in the transitional zone (Transition Zone, TZ), and its main feature is an increase in the number of cells in the transitional zone (Transition Zone, TZ) of the prostate, resulting in an enlarged prostate volume. This enlarged prostate can compress the urethra. After the occurrence of benign prostatic hyperplasia, the most common accompanying symptoms are bladder outlet obstruction (BOO) and lower urinary tract symptoms (LUTS). Lower urinary tract symptoms (LUTS) are a group of common urinary system symptoms, which mainly include the following aspects: ① Symptoms during urination: difficulty in urination, urinary retention; ② Symptoms during urine storage: frequent urination, urgency, increased nocturia; ③ Symptoms after urination: incomplete urination, dribbling after urination. Bladder outlet obstruction (BOO) refers to an obstructive lesion occurring in the urinary tract from the bladder neck to the external urethral orifice. Benign prostatic hyperplasia (BPH) is the most common cause of bladder outlet obstruction. With the increase in age, the prostate volume gradually increases, compressing the urethra and making the urethra narrower, thus hindering the outflow of urine from the bladder. In addition, long-term urethral compression may cause bladder function damage, and the bladder may not be able to empty completely, resulting in an increase in residual urine volume.

[0004] Drug therapy is the preferred method for the treatment of BPH. According to their different mechanisms of action, they can be divided into α1-adrenergic receptor blockers (α1-ARs blocker, such as terazosin hydrochloride, tamsulosin, and prazosin), 5α-reductase inhibitors (5α-RI, such as dutasteride, finasteride, and epristeride), phosphodiesterase inhibitors (PDEI, such as sildenafil), gonadotropin-releasing hormone (GnRH, such as triptorelin, cyproterone acetate, and flutamide), etc. These drugs can mainly relax smooth muscle, relieve the dynamic factors of urinary tract obstruction, quickly relieve symptoms, and play a role in treating the symptoms, but they cannot reverse BPH, are prone to recurrence after drug withdrawal, and cannot achieve the effect of treating the root cause. Moreover, long-term use will produce adverse reactions such as nausea, vomiting, abdominal pain, breast tenderness and enlargement, rash and itching, testicular atrophy, ejaculation disorders, and low sexual function. For example, tamsulosin will cause fatigue, dizziness, ejaculation abnormalities, and hypotension, while finasteride will cause impotence, ejaculation abnormalities, and decreased libido; the adverse reactions of flutamide are gynecomastia and gastrointestinal discomfort in men. Therefore, there is an urgent clinical need to develop new anti-BPH drugs.

[0005] In addition, tracing back to history, due to the limitations of ancient anatomy, the existence of the prostate has been ignored in the development of Eastern and Western medicine. The "Revised New Book of Anatomy" written in the early 19th century mentioned the "prostate gland", which is the earliest record related to the prostate that can be traced in Chinese culture. Therefore, traditional Chinese medicine has insufficient understanding of the prostate from the basic theory, which is also one of the reasons for the poor clinical efficacy of prostate hyperplasia at present. At the same time, benign prostatic hyperplasia is a chronic progressive disease that occurs in the transitional zone. At the beginning of the disease, there are no obvious clinical symptoms, only the prostate volume increases on imaging. We call this part of the patients "pathological prostatic hyperplasia"; as the disease progresses, the lower urinary tract symptoms (LUTS) caused by this gradually worsen, seriously troubling the patients. We call this part of the patients "benign prostatic hyperplasia".

[0006] Currently, traditional Chinese medicine mainly treats benign prostatic hyperplasia through syndrome differentiation and treatment. However, due to the insidious onset of this disease and the lack of obvious early clinical symptoms, it is often difficult to master the core pathogenesis of this disease during clinical treatment. We can only focus on improving the lower urinary tract symptoms of patients with prostate hyperplasia, while ignoring the treatment of the glandular hyperplasia in the transitional zone of the prostate itself, which is also the difficulty in treating this disease clinically.

[0007] Non-patent literature 1: Yu Wenxiao. Guidelines for the Integrated Traditional Chinese and Western Medicine Multidisciplinary Diagnosis and Treatment of Benign Prostatic Hyperplasia (2022 Edition) [J]. Chinese Journal of Andrology, 2022, 36(02): 96-102. Summary of the Invention

[0008] 1. Problems to be Solved

[0009] One of the objectives of the present invention is to provide a traditional Chinese medicine composition, which has remarkable effects on prostate diseases, especially prostate hyperplasia.

[0010] 2. Technical Solution

[0011] To solve the above problems, the technical solutions adopted by the present invention are as follows:

[0012] According to the objective of the present invention, a traditional Chinese medicine composition is provided in the first aspect of the present invention. The traditional Chinese medicine composition is made from the following raw materials: Astragalus membranaceus, Herba Siphonostegiae, Pollen Typhae, Rhizoma Dioscoreae Hypoglaucae, Bombyx batryticatus, Thallus Laminariae, Cortex Cinnamomi, Rhizoma Zedoariae, Herba Euphorbiae Helioscopiae, Plastrum Testudinis, Licorice Root.

[0013] For the traditional Chinese medicine composition according to any implementation scheme of the first aspect of the present invention, calculated by weight parts, the traditional Chinese medicine composition is made from the following raw materials in the following weight parts:

[0014]

[0015] For the traditional Chinese medicine composition according to any implementation scheme of the first aspect of the present invention, calculated by weight parts, the traditional Chinese medicine composition is made from the following raw materials in the following weight parts:

[0016]

[0017] For the traditional Chinese medicine composition according to any implementation scheme of the first aspect of the present invention, calculated by weight parts, the traditional Chinese medicine composition is made from the following raw materials in the following weight parts:

[0018]

[0019] For the traditional Chinese medicine composition according to any implementation scheme of the first aspect of the present invention, calculated by weight parts, the traditional Chinese medicine composition is made from the following raw materials in the following weight parts:

[0020]

[0021]

[0022] For the traditional Chinese medicine composition according to any implementation scheme of the first aspect of the present invention, calculated by weight parts, the traditional Chinese medicine composition is made from the following raw materials in the following weight parts:

[0023]

[0024] The traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, by weight, the ratio of astragalus membranaceus, artemisia anomala s. moore, typha angustata, dioscorea septemloba thunb, bombyx batryticatus, laminaria japonica, cinnamon, zedoary turmeric, euphorbia helioscopia, tortoise shell, and licorice is (10-60):(10-60):(10-60):(5-40):(5-30):(5-30):(1-10):(10-60):(10-30):(2-15):(2-15).

[0025] The traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, by weight, the ratio of astragalus membranaceus, artemisia anomala s. moore, typha angustata, dioscorea septemloba thunb, bombyx batryticatus, laminaria japonica, cinnamon, zedoary turmeric, euphorbia helioscopia, tortoise shell, and licorice is (20-60):(20-60):(20-60):(10-30):(5-25):(5-25):(1-6):(20-60):(5-25):(2-10):(2-10).

[0026] The traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, by weight, the ratio of astragalus membranaceus, artemisia anomala s. moore, typha angustata, dioscorea septemloba thunb, bombyx batryticatus, laminaria japonica, cinnamon, zedoary turmeric, euphorbia helioscopia, tortoise shell, and licorice is (20-40):(20-40):(20-40):(15-25):(10-20):(10-20):(1-5):(20-40):(10-20):(2-9):(2-9).

[0027] The traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, by weight parts, the ratio of astragalus membranaceus, artemisia anomala s. moore, typha angustata, dioscorea septemloba thunb, bombyx batryticatus, laminaria japonica, cinnamon, zedoary turmeric, euphorbia helioscopia, tortoise shell, and licorice is (25-35):(25-35):(25-35):(15-25):(10-20):(10-20):(1-5):(25-35):(10-20):(2-9):(2-9).

[0028] The traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, by weight parts, the ratio of astragalus membranaceus, artemisia anomala s. moore, typha angustata, dioscorea septemloba thunb, bombyx batryticatus, laminaria japonica, cinnamon, zedoary turmeric, euphorbia helioscopia, tortoise shell, and licorice is 30:30:30:20:15:15:3:30:15:6:6.

[0029] The traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, the dosage form of the traditional Chinese medicine composition includes powder, powder for oral use, tablet, pill, capsule, suspension, lozenge, granule, ointment, syrup, oral liquid, cream, drop, suppository, emulsion, patch or plaster.

[0030] The traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, the traditional Chinese medicine composition is for oral use or for skin use.

[0031] In the second aspect of the present invention, a traditional Chinese medicine extract is provided. The extract is made from the following traditional Chinese medicine raw materials: Astragalus membranaceus, Siphonostegia chinensis, Pollen Typhae, Dioscorea septemloba Thunb., Bombyx batryticatus, Ecklonia kurome, Cinnamomum cassia, Rhizoma Zedoariae, Euphorbia helioscopia L., Plastrum Testudinis, and Glycyrrhiza uralensis Fisch.

[0032] For the traditional Chinese medicine extract according to any implementation scheme of the second aspect of the present invention, the extract is made from the following traditional Chinese medicine raw materials by weight:

[0033]

[0034] For the traditional Chinese medicine extract according to any implementation scheme of the second aspect of the present invention, the extract is made from the following traditional Chinese medicine raw materials by weight:

[0035]

[0036] For the traditional Chinese medicine extract according to any implementation scheme of the second aspect of the present invention, the extract is made from the following traditional Chinese medicine raw materials by weight:

[0037]

[0038] For the traditional Chinese medicine extract according to any implementation scheme of the second aspect of the present invention, the extract is made from the following traditional Chinese medicine raw materials by weight:

[0039]

[0040] For the traditional Chinese medicine extract according to any implementation scheme of the second aspect of the present invention, the extract is made from the following traditional Chinese medicine raw materials by weight:

[0041]

[0042] For the traditional Chinese medicine extract according to any implementation scheme of the second aspect of the present invention, the extract is made from the following traditional Chinese medicine raw materials by weight ratio: the ratio of Astragalus membranaceus, Siphonostegia chinensis, Pollen Typhae, Dioscorea septemloba Thunb., Bombyx batryticatus, Ecklonia kurome, Cinnamomum cassia, Rhizoma Zedoariae, Euphorbia helioscopia L., Plastrum Testudinis, and Glycyrrhiza uralensis Fisch. is (10 - 60):(10 - 60):(10 - 60):(5 - 40):(5 - 30):(5 - 30):(1 - 10):(10 - 60):(10 - 30):(2 - 15):(2 - 15).

[0043] The traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, wherein the extract is prepared from traditional Chinese medicine raw materials with the following weight ratios: the ratios of Astragalus membranaceus, Herba Artemisiae Anomalae, Pollen Typhae, Rhizoma Dioscoreae Hypoglaucae, Bombyx Batryticatus, Thallus Laminariae, Cortex Cinnamomi, Rhizoma Zedoariae, Herba Euphorbiae Helioscopiae, Plastrum Testudinis, and Glycyrrhiza uralensis Fisch. are (20 - 60):(20 - 60):(20 - 60):(10 - 30):(5 - 25):(5 - 25):(1 - 6):(20 - 60):(5 - 25):(2 - 10):(2 - 10).

[0044] The traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, wherein the extract is prepared from traditional Chinese medicine raw materials with the following weight ratios: the ratios of Astragalus membranaceus, Herba Artemisiae Anomalae, Pollen Typhae, Rhizoma Dioscoreae Hypoglaucae, Bombyx Batryticatus, Thallus Laminariae, Cortex Cinnamomi, Rhizoma Zedoariae, Herba Euphorbiae Helioscopiae, Plastrum Testudinis, and Glycyrrhiza uralensis Fisch. are (20 - 40):(20 - 40):(20 - 40):(15 - 25):(10 - 20):(10 - 20):(1 - 5):(20 - 40):(10 - 20):(2 - 9):(2 - 9).

[0045] The traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, wherein the dosage forms of the extract include powder, powder for oral use, tablet, pill, capsule, suspension, lozenge, granule, ointment, syrup, oral liquid, cream, drop, suppository, emulsion, patch or plaster.

[0046] The traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, wherein the extract of the traditional Chinese medicine composition is for oral use or for skin use.

[0047] The traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, wherein the extract includes any one or two of water extract and alcohol extract.

[0048] The third aspect of the present invention provides a traditional Chinese medicine extract, and the active ingredients included in the traditional Chinese medicine extract are: the extract of Astragalus membranaceus, the extract of Herba Artemisiae Anomalae, the extract of Pollen Typhae, the extract of Rhizoma Dioscoreae Hypoglaucae, the extract of Bombyx Batryticatus, the extract of Thallus Laminariae, the extract of Rhizoma Zedoariae, the extract of Cortex Cinnamomi, the extract of Herba Euphorbiae Helioscopiae, the extract of Plastrum Testudinis, and the extract of Glycyrrhiza uralensis Fisch.

[0049] The traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention, wherein the extract includes any one or two of water extract and alcohol extract.

[0050] The fourth aspect of the present invention provides the application of the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, or the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, or the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention, in the prevention and / or control and / or treatment of benign prostatic hyperplasia; and / or,

[0051] Use in preventing and / or controlling and / or treating urinary system events.

[0052] The fifth aspect of the present invention provides the use of the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, or the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, or the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention, and the uses include:

[0053] Use in preventing and / or controlling and / or treating prostatic hyperplasia; and / or,

[0054] Use in preventing and / or controlling and / or treating benign prostatic hyperplasia; and / or,

[0055] Use in preventing and / or controlling and / or treating diseases characterized by an increase in prostate wet weight; and / or,

[0056] Use in preventing and / or controlling and / or treating diseases characterized by an increase in prostate index; and / or,

[0057] Use in preventing and / or controlling and / or treating diseases characterized by prostatic gland hyperplasia; and / or,

[0058] Use in preventing and / or controlling and / or treating diseases characterized by prostatic stromal hyperplasia; and / or,

[0059] Use in preventing and / or controlling and / or treating diseases characterized by an increase in prostate volume; and / or,

[0060] Use in preventing and / or controlling and / or treating diseases characterized by an increase in prostate volume; and / or,

[0061] Use in preventing and / or controlling and / or treating diseases characterized by an increase in the number of transitional zone cells in the prostate; and / or,

[0062] Use in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the glandular region of the prostate; and / or,

[0063] Use in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0064] Use in preventing and / or controlling and / or treating diseases characterized by hyperplasia of prostatic glandular epithelial cells; and / or,

[0065] Use in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0066] Use in preventing and / or controlling and / or treating diseases characterized by bladder outlet obstruction; and / or,

[0067] Use in preventing and / or controlling and / or treating diseases characterized by lower urinary tract symptoms; and / or,

[0068] Use in preventing and / or controlling and / or treating prostate diseases characterized by increased prostate wet weight; and / or,

[0069] Use in preventing and / or controlling and / or treating prostate diseases characterized by increased prostate index; and / or,

[0070] Use in preventing and / or controlling and / or treating prostate diseases characterized by prostate gland hyperplasia; and / or,

[0071] Use in preventing and / or controlling and / or treating prostate diseases characterized by prostate stromal hyperplasia; and / or,

[0072] Use in preventing and / or controlling and / or treating prostate diseases characterized by increased prostate volume; and / or,

[0073] Use in preventing and / or controlling and / or treating prostate diseases characterized by increased number of transitional zone cells in the prostate; and / or,

[0074] Use in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of the glandular region of the prostate; and / or,

[0075] Use in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0076] Use in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of glandular epithelial cells in the prostate; and / or,

[0077] Use in preventing and / or controlling and / or treating prostate diseases characterized by smooth muscle hyperplasia of the bladder; and / or,

[0078] Use in preventing and / or controlling and / or treating prostate diseases characterized by bladder outlet obstruction; and / or,

[0079] Use in preventing and / or controlling and / or treating prostate diseases characterized by lower urinary tract symptoms; and / or,

[0080] Use in preventing and / or controlling and / or treating prostate hyperplasia characterized by increased prostate wet weight; and / or,

[0081] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by an increased prostate index; and / or,

[0082] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by hyperplasia of the prostate gland; and / or,

[0083] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by hyperplasia of the prostate stroma; and / or,

[0084] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by an enlarged prostate volume; and / or,

[0085] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by an increased number of cells in the transitional zone of the prostate; and / or,

[0086] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by hyperplasia of the glandular area of the prostate; and / or,

[0087] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0088] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by hyperplasia of the prostatic epithelial cells; and / or,

[0089] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0090] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by bladder outlet obstruction; and / or,

[0091] Use in the prevention and / or control and / or treatment of prostate hyperplasia characterized by lower urinary tract symptoms; and / or,

[0092] Use in the prevention and / or control and / or treatment of benign prostatic hyperplasia characterized by an increased wet weight of the prostate; and / or,

[0093] Use in the prevention and / or control and / or treatment of benign prostatic hyperplasia characterized by an increased prostate index; and / or,

[0094] Use in the prevention and / or control and / or treatment of benign prostatic hyperplasia characterized by hyperplasia of the prostate gland; and / or,

[0095] Use in the prevention and / or control and / or treatment of benign prostatic hyperplasia characterized by hyperplasia of the prostate stroma; and / or,

[0096] Use in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an enlarged prostate volume; and / or,

[0097] Use in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increased number of transitional zone cells in the prostate; and / or,

[0098] Use in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the glandular area of the prostate; and / or,

[0099] Use in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0100] Use in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of prostatic glandular epithelial cells; and / or,

[0101] Use in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0102] Use in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0103] Use in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by lower urinary tract symptoms; and / or,

[0104] Use in preventing and / or controlling and / or treating urinary system events; and / or,

[0105] Use in preventing and / or controlling and / or urinary system events.

[0106] The sixth aspect of the present invention provides the use of the traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, or the traditional Chinese medicine extract according to any one of the embodiments of the second aspect of the present invention, or the traditional Chinese medicine extract according to any one of the embodiments of the third aspect of the present invention, and the uses include: being applied in the preparation of a drug or a health product or a nutritional product for preventing and / or controlling and / or treating benign prostatic hyperplasia;

[0107] Or, being applied in the preparation of a drug or a health product or a nutritional product for preventing and / or controlling and / or treating urinary system events.

[0108] The seventh aspect of the present invention provides the use of the traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, or the traditional Chinese medicine extract according to any one of the embodiments of the second aspect of the present invention, or the traditional Chinese medicine extract according to any one of the embodiments of the third aspect of the present invention, and the uses include:

[0109] Use in the preparation of a product for preventing and / or controlling and / or treating any of the following aspects:

[0110] Prostatic hyperplasia; and / or,

[0111] Benign prostatic hyperplasia; and / or,

[0112] Diseases characterized by an increase in prostate wet weight; and / or,

[0113] Diseases characterized by an increase in prostate index; and / or,

[0114] Diseases characterized by prostatic glandular hyperplasia; and / or,

[0115] Diseases characterized by prostatic stromal hyperplasia; and / or,

[0116] Diseases characterized by an increase in prostate volume; and / or,

[0117] Diseases characterized by an increase in prostate volume; and / or,

[0118] Diseases characterized by an increase in the number of transitional zone cells of the prostate; and / or diseases characterized by hyperplasia of the glandular zone of the prostate; and / or,

[0119] Diseases characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0120] Diseases characterized by hyperplasia of prostatic glandular epithelial cells; and / or,

[0121] Diseases characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0122] Diseases characterized by bladder outlet obstruction; and / or,

[0123] Diseases characterized by lower urinary tract symptoms; and / or,

[0124] Prostatic diseases characterized by an increase in prostate wet weight; and / or,

[0125] Prostatic diseases characterized by an increase in prostate index; and / or,

[0126] Prostatic diseases characterized by prostatic glandular hyperplasia; and / or,

[0127] Prostatic diseases characterized by prostatic stromal hyperplasia; and / or,

[0128] Prostatic diseases characterized by an increase in prostate volume; and / or,

[0129] Prostate diseases characterized by an increased number of transitional zone cells in the prostate; and / or, prostate diseases characterized by hyperplasia of the glandular region of the prostate; and / or, prostate diseases characterized by hyperplasia of the transitional zone of the prostate; and / or, prostate diseases characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or, prostate diseases characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0130] Prostate diseases characterized by bladder outlet obstruction; and / or,

[0131] Prostate diseases characterized by lower urinary tract symptoms; and / or,

[0132] Benign prostatic hyperplasia characterized by an increase in prostate wet weight; and / or,

[0133] Benign prostatic hyperplasia characterized by an increase in prostate index; and / or,

[0134] Benign prostatic hyperplasia characterized by hyperplasia of the prostate gland; and / or,

[0135] Benign prostatic hyperplasia characterized by hyperplasia of the prostate stroma; and / or,

[0136] Benign prostatic hyperplasia characterized by an increase in prostate volume; and / or,

[0137] Benign prostatic hyperplasia characterized by an increased number of transitional zone cells in the prostate; and / or, benign prostatic hyperplasia characterized by hyperplasia of the glandular region of the prostate; and / or, benign prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or, benign prostatic hyperplasia characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or, benign prostatic hyperplasia characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0138] Benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0139] Benign prostatic hyperplasia characterized by lower urinary tract symptoms; and / or,

[0140] Benign prostatic hyperplasia characterized by an increase in prostate wet weight; and / or, benign prostatic hyperplasia characterized by an increase in prostate index; and / or, benign prostatic hyperplasia characterized by hyperplasia of the prostate gland; and / or, benign prostatic hyperplasia characterized by hyperplasia of the prostate stroma; and / or, benign prostatic hyperplasia characterized by an increase in prostate volume; and / or, benign prostatic hyperplasia characterized by an increased number of transitional zone cells in the prostate; and / or, benign prostatic hyperplasia characterized by hyperplasia of the glandular region of the prostate; and / or, benign prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or, benign prostatic hyperplasia characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0141] Benign prostatic hyperplasia characterized by smooth muscle hyperplasia of the bladder; and / or,

[0142] Benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0143] Benign prostatic hyperplasia characterized by lower urinary tract symptoms; and / or,

[0144] Treating urinary system events.

[0145] The application according to any embodiment of the seventh aspect of the present invention, wherein the product retains any one of drugs, health products, and nutritional products.

[0146] The eighth aspect of the present invention provides a drug having any one of the following effects, wherein the drug is the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0147] Or,

[0148] The drug comprises the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0149] The effects include:

[0150] Preventing and / or controlling and / or treating benign prostatic hyperplasia; and / or,

[0151] Preventing and / or controlling and / or treating urinary system events.

[0152] The ninth aspect of the present invention provides a drug having any one of the following effects, wherein the drug is the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0153] Or,

[0154] The drug comprises the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0155] The effects include:

[0156] The effect of preventing and / or controlling and / or treating prostatic hyperplasia; and / or,

[0157] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia; and / or,

[0158] Role in preventing and / or controlling and / or treating diseases characterized by an increase in prostate wet weight; and / or,

[0159] Role in preventing and / or controlling and / or treating diseases characterized by an increase in prostate index; and / or,

[0160] Role in preventing and / or controlling and / or treating diseases characterized by prostate gland hyperplasia; and / or,

[0161] Role in preventing and / or controlling and / or treating diseases characterized by prostate stromal hyperplasia; and / or,

[0162] Role in preventing and / or controlling and / or treating diseases characterized by an increase in prostate volume; and / or,

[0163] Role in preventing and / or controlling and / or treating diseases characterized by an increase in prostate volume; and / or,

[0164] Role in preventing and / or controlling and / or treating diseases characterized by an increase in the number of transitional zone cells in the prostate; and / or,

[0165] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the glandular region of the prostate; and / or,

[0166] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0167] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0168] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0169] Role in preventing and / or controlling and / or treating diseases characterized by bladder outlet obstruction; and / or,

[0170] Role in preventing and / or controlling and / or treating diseases characterized by lower urinary tract symptoms; and / or,

[0171] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increase in prostate wet weight; and / or,

[0172] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increase in prostate index; and / or,

[0173] Role in preventing and / or controlling and / or treating prostate diseases characterized by prostatic gland hyperplasia; and / or,

[0174] Role in preventing and / or controlling and / or treating prostate diseases characterized by prostatic stromal hyperplasia; and / or,

[0175] Role in preventing and / or controlling and / or treating prostate diseases characterized by an enlarged prostate volume; and / or,

[0176] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increased number of transitional zone cells in the prostate; and / or,

[0177] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of the glandular region of the prostate; and / or,

[0178] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0179] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of prostatic glandular epithelial cells; and / or,

[0180] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0181] Role in preventing and / or controlling and / or treating prostate diseases characterized by bladder outlet obstruction; and / or,

[0182] Role in preventing and / or controlling and / or treating prostate diseases characterized by lower urinary tract symptoms; and / or,

[0183] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by an increased wet weight of the prostate; and / or,

[0184] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by an increased prostate index; and / or,

[0185] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by prostatic gland hyperplasia; and / or,

[0186] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by prostatic stromal hyperplasia; and / or,

[0187] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by an enlarged prostate volume; and / or,

[0188] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in the number of transitional zone cells of the prostate; and / or,

[0189] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the glandular region of the prostate; and / or,

[0190] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0191] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0192] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0193] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0194] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by lower urinary tract symptoms; and / or,

[0195] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in the wet weight of the prostate; and / or,

[0196] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in the prostate index; and / or,

[0197] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the prostate gland; and / or,

[0198] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the prostate stroma; and / or,

[0199] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in the volume of the prostate; and / or,

[0200] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in the number of transitional zone cells of the prostate; and / or,

[0201] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the glandular region of the prostate; and / or,

[0202] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0203] Use in the prevention and / or control and / or treatment of benign prostatic hyperplasia characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0204] Use in the prevention and / or control and / or treatment of benign prostatic hyperplasia characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0205] Use in the prevention and / or control and / or treatment of benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0206] Use in the prevention and / or control and / or treatment of benign prostatic hyperplasia characterized by lower urinary tract symptoms; and / or,

[0207] Use in the prevention and / or control and / or treatment of urinary system events.

[0208] A drug according to any embodiment of the ninth aspect of the present invention, the drug further comprising a pharmaceutically acceptable excipient and / or carrier and / or adjuvant.

[0209] A drug according to any embodiment of the ninth aspect of the present invention, the pharmaceutically acceptable excipient comprising an inert diluent, a dispersant and / or a granulating agent, a surfactant and / or an emulsifier, a disintegrant, a binder, a preservative, a buffer, a lubricant and / or an oil.

[0210] The adjuvant comprises a colorant, a coating agent, a sweetening agent, a flavoring agent and an aromatic agent.

[0211] A drug according to any embodiment of the ninth aspect of the present invention, the dosage form of the drug comprising a powder, a powder, a tablet, a pill, a capsule, a suspension, a lozenge, a granule, an ointment, a syrup, an oral liquid, a cream, a drop, a suppository, an emulsion, a patch or a plaster.

[0212] A drug according to any embodiment of the ninth aspect of the present invention, the drug is for oral use or for transdermal use.

[0213] The tenth aspect of the present invention provides a health product having any of the following described effects, the health product being the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0214] Or,

[0215] The health product comprises the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or, the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0216] The functions include:

[0217] Preventing and / or controlling and / or treating benign prostatic hyperplasia; and / or,

[0218] Preventing and / or controlling and / or treating urinary system events.

[0219] The eleventh aspect of the present invention provides a health product having any one of the following functions, the health product being the traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, and / or, the traditional Chinese medicine extract according to any one of the embodiments of the second aspect of the present invention, and / or, the traditional Chinese medicine extract according to any one of the embodiments of the third aspect of the present invention;

[0220] Or,

[0221] The health product comprises the traditional Chinese medicine composition according to any one of the embodiments of the first aspect of the present invention, and / or, the traditional Chinese medicine extract according to any one of the embodiments of the second aspect of the present invention, and / or, the traditional Chinese medicine extract according to any one of the embodiments of the third aspect of the present invention;

[0222] The functions include:

[0223] Functions in preventing and / or controlling and / or treating prostatic hyperplasia; and / or,

[0224] Functions in preventing and / or controlling and / or treating benign prostatic hyperplasia; and / or,

[0225] Functions in preventing and / or controlling and / or treating diseases characterized by an increase in prostate wet weight; and / or,

[0226] Functions in preventing and / or controlling and / or treating diseases characterized by an increase in prostate index; and / or,

[0227] Functions in preventing and / or controlling and / or treating diseases characterized by prostatic gland hyperplasia; and / or,

[0228] Functions in preventing and / or controlling and / or treating diseases characterized by prostatic stromal hyperplasia; and / or,

[0229] Functions in preventing and / or controlling and / or treating diseases characterized by an increase in prostate volume; and / or,

[0230] Functions in preventing and / or controlling and / or treating diseases characterized by an increase in prostate volume; and / or,

[0231] Functions in preventing and / or controlling and / or treating diseases characterized by an increase in the number of transitional zone cells in the prostate; and / or,

[0232] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia in the glandular region of the prostate; and / or,

[0233] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia in the transitional zone of the prostate; and / or,

[0234] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of glandular epithelial cells in the prostate; and / or,

[0235] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the smooth muscle in the bladder; and / or,

[0236] Role in preventing and / or controlling and / or treating diseases characterized by bladder outlet obstruction; and / or,

[0237] Role in preventing and / or controlling and / or treating diseases characterized by lower urinary tract symptoms; and / or,

[0238] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increase in prostate wet weight; and / or,

[0239] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increase in prostate index; and / or,

[0240] Role in preventing and / or controlling and / or treating prostate diseases characterized by prostate gland hyperplasia; and / or,

[0241] Role in preventing and / or controlling and / or treating prostate diseases characterized by prostate stromal hyperplasia; and / or,

[0242] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increase in prostate volume; and / or,

[0243] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increase in the number of transitional zone cells in the prostate; and / or,

[0244] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia in the glandular region of the prostate; and / or,

[0245] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia in the transitional zone of the prostate; and / or,

[0246] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of glandular epithelial cells in the prostate; and / or,

[0247] Role in preventing and / or controlling and / or treating prostate diseases characterized by smooth muscle hyperplasia of the bladder; and / or,

[0248] Role in preventing and / or controlling and / or treating prostate diseases characterized by bladder outlet obstruction; and / or,

[0249] Role in preventing and / or controlling and / or treating prostate diseases characterized by lower urinary tract symptoms; and / or,

[0250] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by increased prostate wet weight; and / or,

[0251] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by increased prostate index; and / or,

[0252] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by prostate gland hyperplasia; and / or,

[0253] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by prostate stromal hyperplasia; and / or,

[0254] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by increased prostate volume; and / or,

[0255] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by increased number of transitional zone cells in the prostate; and / or,

[0256] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by hyperplasia of the glandular area of the prostate; and / or,

[0257] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0258] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by hyperplasia of prostatic gland epithelial cells; and / or,

[0259] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by smooth muscle hyperplasia of the bladder; and / or,

[0260] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by bladder outlet obstruction; and / or,

[0261] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by lower urinary tract symptoms; and / or,

[0262] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in prostate wet weight; and / or,

[0263] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in prostate index; and / or,

[0264] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by prostate gland hyperplasia; and / or,

[0265] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by prostate stromal hyperplasia; and / or,

[0266] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in prostate volume; and / or,

[0267] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in the number of transitional zone cells in the prostate; and / or,

[0268] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia in the glandular area of the prostate; and / or,

[0269] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia in the transitional zone of the prostate; and / or,

[0270] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of prostatic glandular epithelial cells; and / or,

[0271] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by smooth muscle hyperplasia of the bladder; and / or,

[0272] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0273] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by lower urinary tract symptoms; and / or,

[0274] Role in preventing and / or controlling and / or treating urinary system events.

[0275] A health product according to any embodiment of the eleventh aspect of the present invention, the health product further comprising acceptable excipients or additives.

[0276] A health product according to any embodiment of the eleventh aspect of the present invention, wherein the acceptable excipients or additives of the health product include fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices.

[0277] A health product according to any embodiment of the eleventh aspect of the present invention, wherein the dosage forms of the health product include powders, powders for external use, tablets, pills, capsules, suspensions, lozenges, granules, ointments, syrups, oral liquids, creams, drops, suppositories, emulsions, patches or cataplasms.

[0278] The twelfth aspect of the present invention provides a nutritional product having any one of the following functions, wherein the nutritional product is the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0279] Or,

[0280] The nutritional product contains the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0281] The functions include:

[0282] Preventing and / or controlling and / or treating benign prostatic hyperplasia; and / or,

[0283] Preventing and / or controlling and / or treating urinary system events.

[0284] The thirteenth aspect of the present invention provides a nutritional product having any one of the following functions, wherein the nutritional product is the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0285] Or,

[0286] The nutritional product contains the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, and / or the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, and / or the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention;

[0287] The functions include:

[0288] The function of preventing and / or controlling and / or treating prostate hyperplasia; and / or,

[0289] The function of preventing and / or controlling and / or treating benign prostatic hyperplasia; and / or,

[0290] Role in preventing and / or controlling and / or treating diseases characterized by an increase in prostate wet weight; and / or,

[0291] Role in preventing and / or controlling and / or treating diseases characterized by an increase in prostate index; and / or,

[0292] Role in preventing and / or controlling and / or treating diseases characterized by prostate gland hyperplasia; and / or,

[0293] Role in preventing and / or controlling and / or treating diseases characterized by prostate stromal hyperplasia; and / or,

[0294] Role in preventing and / or controlling and / or treating diseases characterized by an increase in prostate volume; and / or,

[0295] Role in preventing and / or controlling and / or treating diseases characterized by an increase in prostate volume; and / or,

[0296] Role in preventing and / or controlling and / or treating diseases characterized by an increase in the number of transitional zone cells in the prostate; and / or,

[0297] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the glandular region of the prostate; and / or,

[0298] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0299] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0300] Role in preventing and / or controlling and / or treating diseases characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0301] Role in preventing and / or controlling and / or treating diseases characterized by bladder outlet obstruction; and / or,

[0302] Role in preventing and / or controlling and / or treating diseases characterized by lower urinary tract symptoms; and / or,

[0303] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increase in prostate wet weight; and / or,

[0304] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increase in prostate index; and / or,

[0305] Role in preventing and / or controlling and / or treating prostate diseases characterized by prostate gland hyperplasia; and / or,

[0306] Role in preventing and / or controlling and / or treating prostate diseases characterized by prostate stromal hyperplasia; and / or,

[0307] Role in preventing and / or controlling and / or treating prostate diseases characterized by an enlarged prostate volume; and / or,

[0308] Role in preventing and / or controlling and / or treating prostate diseases characterized by an increased number of transitional zone cells in the prostate; and / or,

[0309] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of the glandular region of the prostate; and / or,

[0310] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0311] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0312] Role in preventing and / or controlling and / or treating prostate diseases characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0313] Role in preventing and / or controlling and / or treating prostate diseases characterized by bladder outlet obstruction; and / or,

[0314] Role in preventing and / or controlling and / or treating prostate diseases characterized by lower urinary tract symptoms; and / or,

[0315] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by an increase in prostate wet weight; and / or,

[0316] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by an increase in prostate index; and / or,

[0317] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by prostate gland hyperplasia; and / or,

[0318] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by prostate stromal hyperplasia; and / or,

[0319] Role in preventing and / or controlling and / or treating prostate hyperplasia characterized by an enlarged prostate volume; and / or,

[0320] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in the number of transitional zone cells of the prostate; and / or,

[0321] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the glandular region of the prostate; and / or,

[0322] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0323] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0324] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0325] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0326] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by lower urinary tract symptoms; and / or,

[0327] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in prostate wet weight; and / or,

[0328] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in prostate index; and / or,

[0329] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the prostate gland; and / or,

[0330] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the prostate stroma; and / or,

[0331] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in prostate volume; and / or,

[0332] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by an increase in the number of transitional zone cells of the prostate; and / or,

[0333] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the glandular region of the prostate; and / or,

[0334] Role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0335] Its role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0336] Its role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0337] Its role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0338] Its role in preventing and / or controlling and / or treating benign prostatic hyperplasia characterized by lower urinary tract symptoms; and / or

[0339] Its role in preventing and / or controlling and / or treating urinary system events.

[0340] A nutritional product according to any embodiment of the thirteenth aspect of the present invention, the nutritional product further comprising acceptable excipients or additives.

[0341] A nutritional product according to any embodiment of the thirteenth aspect of the present invention, the acceptable excipients or additives of the nutritional product including fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, matrices.

[0342] A nutritional product according to any embodiment of the thirteenth aspect of the present invention, the dosage form of the nutritional product including powders, powders for external use, tablets, pills, capsules, suspensions, lozenges, granules, ointments, syrups, oral liquids, creams, drops, suppositories, emulsions, patches or plasters.

[0343] For the traditional Chinese medicine composition according to any embodiment of the first aspect of the present invention, or the traditional Chinese medicine extract according to any embodiment of the second aspect of the present invention, or the traditional Chinese medicine extract according to any embodiment of the third aspect of the present invention, or the drug, health product, nutritional product according to any embodiment of the sixth aspect of the present invention, or the drug, health product, nutritional product according to any embodiment of the seventh aspect of the present invention, or the drug according to any embodiment of the eighth aspect of the present invention, or the drug according to any embodiment of the ninth aspect of the present invention, or the health product according to any embodiment of the tenth aspect of the present invention, or the health product according to any embodiment of the eleventh aspect of the present invention, or the nutritional product according to any embodiment of the twelfth aspect of the present invention, or the nutritional product according to any embodiment of the thirteenth aspect of the present invention, the fourteenth aspect of the present invention provides the preparation of any of the above-mentioned traditional Chinese medicine composition, traditional Chinese medicine extract, traditional Chinese medicine, health product, nutritional product, including the steps of: proportioning each raw material, soaking in a solvent, and decocting.

[0344] Preparation according to any embodiment of the fourteenth aspect of the present invention, wherein the solvent comprises water and / or alcohol.

[0345] Preparation according to any embodiment of the fourteenth aspect of the present invention, wherein the soaking time is 30 to 60 minutes.

[0346] Preparation according to any embodiment of the fourteenth aspect of the present invention, wherein the decocting comprises first decocting with strong fire and then decocting with slow fire;

[0347] The time for decocting with strong fire is 45 to 75 minutes; the time for decocting with slow fire is 15 to 45 minutes.

[0348] Preparation according to any embodiment of the fourteenth aspect of the present invention, specifically comprising: proportioning each raw material according to quantity, mixing with a solvent and soaking, and after the soaking is completed, first decocting with strong fire and then decocting with slow fire.

[0349] As described herein, for soaking or decocting, it is preferred to use ceramic containers such as earthenware pots and crocks, and avoid using metal utensils such as copper, iron, and aluminum. Put each traditional Chinese medicine slice in the above traditional Chinese medicine composition into the decocting container according to the dosage ratio, add cold water, and the amount of water added is preferably 2 - 3 cm higher than the surface of the medicine. Soak for 30 minutes to 1 hour. After the soaking is completed, first bring the medicinal liquid to a boil with strong fire (vigorous fire), and then continue to decoct with slow fire (gentle fire). Filter and pour out the medicinal liquid after the first decoction, add an appropriate amount of cold water for the second decoction, and pour out the medicinal liquid of the second decoction. Decoct for 1 hour for the first time and 30 minutes for the second time, mix the medicinal liquids obtained from the two decoctions, filter, and thus complete the preparation of the above traditional Chinese medicine composition decoction.

[0350] The fifteenth aspect of the present invention provides a method for treating and / or controlling and / or preventing any of the following diseases, wherein the diseases include:

[0351] Prostatic hyperplasia; and / or,

[0352] Benign prostatic hyperplasia; and / or,

[0353] Diseases characterized by an increase in prostate wet weight; and / or,

[0354] Diseases characterized by an increase in prostate index; and / or,

[0355] Diseases characterized by prostatic gland hyperplasia; and / or,

[0356] Diseases characterized by prostatic stromal hyperplasia; and / or,

[0357] Diseases characterized by an increase in prostate volume; and / or,

[0358] Diseases characterized by an increase in prostate volume; and / or,

[0359] A disease characterized by an increased number of transitional zone cells in the prostate; and / or,

[0360] A disease characterized by hyperplasia of the glandular region of the prostate; and / or,

[0361] A disease characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0362] A disease characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0363] A disease characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0364] A disease characterized by bladder outlet obstruction; and / or,

[0365] A disease characterized by lower urinary tract symptoms; and / or,

[0366] A prostate disease characterized by an increase in prostate wet weight; and / or,

[0367] A prostate disease characterized by an increase in prostate index; and / or,

[0368] A prostate disease characterized by hyperplasia of the prostate glands; and / or,

[0369] A prostate disease characterized by hyperplasia of the prostate stroma; and / or,

[0370] A prostate disease characterized by an increase in prostate volume; and / or,

[0371] A prostate disease characterized by an increased number of transitional zone cells in the prostate; and / or,

[0372] A prostate disease characterized by hyperplasia of the glandular region of the prostate; and / or,

[0373] A prostate disease characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0374] A prostate disease characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or,

[0375] A prostate disease characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0376] A prostate disease characterized by bladder outlet obstruction; and / or,

[0377] A prostate disease characterized by lower urinary tract symptoms; and / or,

[0378] Prostate hyperplasia characterized by an increase in prostate wet weight; and / or,

[0379] Prostatic hyperplasia characterized by an increased prostate index; and / or,

[0380] Prostatic hyperplasia characterized by hyperplasia of the prostate gland; and / or,

[0381] Prostatic hyperplasia characterized by hyperplasia of the prostate stroma; and / or,

[0382] Prostatic hyperplasia characterized by an enlarged prostate volume; and / or,

[0383] Prostatic hyperplasia characterized by an increased number of cells in the transitional zone of the prostate; and / or,

[0384] Prostatic hyperplasia characterized by hyperplasia of the glandular region of the prostate; and / or,

[0385] Prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0386] Prostatic hyperplasia characterized by hyperplasia of the prostatic glandular epithelial cells; and / or,

[0387] Prostatic hyperplasia characterized by hyperplasia of the smooth muscle of the bladder; and / or,

[0388] Prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0389] Prostatic hyperplasia characterized by lower urinary tract symptoms; and / or,

[0390] Benign prostatic hyperplasia characterized by an increased wet weight of the prostate; and / or,

[0391] Benign prostatic hyperplasia characterized by an increased prostate index; and / or,

[0392] Benign prostatic hyperplasia characterized by hyperplasia of the prostate gland; and / or,

[0393] Benign prostatic hyperplasia characterized by hyperplasia of the prostate stroma; and / or,

[0394] Benign prostatic hyperplasia characterized by an enlarged prostate volume; and / or,

[0395] Benign prostatic hyperplasia characterized by an increased number of cells in the transitional zone of the prostate; and / or,

[0396] Benign prostatic hyperplasia characterized by hyperplasia of the glandular region of the prostate; and / or,

[0397] Benign prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or,

[0398] Benign prostatic hyperplasia characterized by hyperplasia of the prostatic glandular epithelial cells; and / or,

[0399] Benign prostatic hyperplasia characterized by smooth muscle hyperplasia of the bladder; and / or,

[0400] Benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or,

[0401] Benign prostatic hyperplasia characterized by lower urinary tract symptoms;

[0402] The method includes: using the traditional Chinese medicine composition described in any embodiment of the first aspect of the present invention, or the traditional Chinese medicine extract described in any embodiment of the second aspect of the present invention, or the traditional Chinese medicine extract described in any embodiment of the third aspect of the present invention, or the drug, health product, nutritional product described in any embodiment of the sixth aspect of the present invention, or the drug, health product, nutritional product described in any embodiment of the seventh aspect of the present invention, or the drug described in any embodiment of the eighth aspect of the present invention, or the drug described in any embodiment of the ninth aspect of the present invention, or the health product described in any embodiment of the tenth aspect of the present invention, or the health product described in any embodiment of the eleventh aspect of the present invention, or the nutritional product described in any embodiment of the twelfth aspect of the present invention, or the nutritional product described in any embodiment of the thirteenth aspect of the present invention.

[0403] The sixteenth aspect of the present invention provides a method for the treatment and / or control and / or prevention of urinary system events;

[0404] The method includes: using the traditional Chinese medicine composition described in any embodiment of the first aspect of the present invention, or the traditional Chinese medicine extract described in any embodiment of the second aspect of the present invention, or the traditional Chinese medicine extract described in any embodiment of the third aspect of the present invention, or the drug, health product, nutritional product described in any embodiment of the sixth aspect of the present invention, or the drug, health product, nutritional product described in any embodiment of the seventh aspect of the present invention, or the drug described in any embodiment of the eighth aspect of the present invention, or the drug described in any embodiment of the ninth aspect of the present invention, or the health product described in any embodiment of the tenth aspect of the present invention, or the health product described in any embodiment of the eleventh aspect of the present invention, or the nutritional product described in any embodiment of the twelfth aspect of the present invention, or the nutritional product described in any embodiment of the thirteenth aspect of the present invention. Description of the Drawings

[0405] Figure 1 For the comparison of serum liver and kidney functions of rats in each group: P>0.05, there is no difference between groups;

[0406] Figure 2 Ultrasonic imaging of the ventral lobe of the prostate, seminal vesicles, and bladder of experimental rats (↑ indicates the left and right ventral lobes; * indicates the bladder; △ indicates the left and right seminal vesicles);

[0407] Figure 3 Comparison of the ultrasonic cross-sectional areas of the ventral lobes of the prostate in each group of rats. A: Left ventral lobe (VP-L-Area); B: Right ventral lobe (VP-R-Area). Compared with the Control group, #P < 0.0001; compared with the Model group, ****P < 0.0001; compared with YQHX-D, ns: P > 0.05;

[0408] Figure 4 Gross specimens of the left and right ventral lobes of the prostate in each group of rats;

[0409] Figure 5 Comparison of the prostate ventral lobe index (PI) in each group of experimental rats: Compared with the Control group, #P < 0.0001; compared with the Model group, *P < 0.05, **P < 0.01, ****P < 0.0001; compared with YQHX-D, ns: P > 0.05;

[0410] Figure 6 HE staining of the left ventral lobe tissue of the prostate in each group of rats.

[0411] Beneficial effects

[0412] (1) The traditional Chinese medicine composition or the extract of the traditional Chinese medicine composition provided by the present invention is a new traditional Chinese medicine formula for treating prostate lesions constructed under the guidance of the new idea of "differentiating syndromes of prostate meridian qi and blood", fully considering the inherent physiological differences of different prostate regions, and on this basis, analyzing the pathological characteristics and pathogenesis of diseases. It is particularly suitable for treating, controlling or preventing benign prostatic hyperplasia (BPH) and preventing urinary system events, such as reducing the risk of acute urinary retention and reducing the risk of transurethral resection of the prostate (TURP) and prostatectomy.

[0413] (2) Different from the existing treatment ideas that target symptoms, the traditional Chinese medicine composition or the extract of the traditional Chinese medicine composition provided by the present invention fundamentally treats the cause / lesion site that causes benign prostatic hyperplasia lesions, shrinks the enlarged prostate, improves urine flow and improves the symptoms related to prostate hyperplasia. Fundamentally prevent or treat the onset of benign prostatic hyperplasia, achieving true "treating the root cause" rather than simply "treating the symptoms".

[0414] (3) The traditional Chinese medicine composition formula provided by the present invention has a significant curative effect on benign prostatic hyperplasia model rats, can significantly reduce the wet weight and index of the prostate, can maintain the normal secretory function of glandular epithelial cells, and has an improvement effect on both glandular hyperplasia and interstitial hyperplasia of the prostate. Detailed implementation manners

[0415] The present disclosure can be more readily understood by reference to the following description in conjunction with the accompanying drawings and examples, all of which form a part of the present disclosure. It should be understood that the present disclosure is not limited to the specific products, methods, conditions or parameters described and / or illustrated herein. Further, the terms used herein are for the purpose of describing particular embodiments by way of example only and are not intended to be limiting unless otherwise specified.

[0416] It should be noted that the terms used herein are merely for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present invention. It should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terms used in the embodiments of the present invention are for describing specific embodiments and not for limiting the scope of protection of the present invention. For experimental methods not specified with specific conditions in the following specific embodiments, they are generally carried out according to the conventional methods and conditions of molecular biology in the art, and such techniques and conditions are fully explained in the literature.

[0417] It should also be understood that, for clarity, certain features of the present disclosure may be described herein in the context of separate embodiments, but may also be provided in combination with each other in a single embodiment. That is, unless clearly incompatible or specifically excluded, each individual embodiment is considered combinable with any other embodiment, and such combination is considered to represent another distinct embodiment. Conversely, for the sake of brevity, the various features of the present disclosure described in the context of a single embodiment may also be provided individually or in any sub-combination. Finally, although a particular embodiment may be described as part of a series of steps or part of a more general structure, each step or sub-structure itself may also be considered an independent embodiment.

[0418] Unless otherwise specified, it should be understood that each individual element in a list and each combination of the individual elements in the list will be construed as a different embodiment. For example, a list of embodiments represented as "A, B, or C" should be construed as including the embodiments "A", "B", "C", "A or B", "A or C", "B or C", or "A, B, or C".

[0419] In this document, the endpoints and any values in the disclosed ranges are not limited to the exact ranges or values, and these ranges or values should be understood to include values close to these ranges or values. For numerical ranges, between the endpoint values of each range, between the endpoint values of each range and individual point values, and between individual point values, they can be combined with each other to obtain one or more new numerical ranges, and these numerical ranges should be regarded as specifically disclosed in this document. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" as used herein include both singular and plural referents. A numerical range expressed by endpoints includes all the numerical values and fractions within the corresponding range, as well as the expressed endpoints, unless the context clearly states otherwise.

[0420] In this document, the mention of "substance" refers to at least one of such substance and its equivalents.

[0421] When describing items by using conjunctive terms such as "……and / or……", etc., the description should be understood to include any one of the associated listed items and all combinations of one or more of them.

[0422] Generally, the use of the term "about" indicates an approximate value that can vary according to the desired characteristics obtained from the disclosed subject matter, and will be interpreted in a context-dependent manner based on function. Therefore, those of ordinary skill in the art will be able to interpret a certain degree of difference on a case-by-case basis. In some cases, the number of significant digits used when expressing a specific value can be a representative technique for determining the difference allowed by the term "about". In other cases, the gradient in a series of values can be used to determine the range of differences allowed by the term "about". Further, all ranges in this disclosure are inclusive and combinable, and the mention of the values stated in the range includes each value within that range.

[0423] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this invention pertains; the terms and / or used herein include any and all combinations of one or more of the associated listed items.

[0424] In this document, the "drug" mentioned herein includes the aforementioned traditional Chinese medicine composition or the aforementioned traditional Chinese medicine extract and pharmaceutically acceptable excipients. In a specific embodiment, the traditional Chinese medicine composition or the aforementioned traditional Chinese medicine extract described in the present invention is provided in the drug in an effective amount (such as a therapeutically effective amount).

[0425] As used herein, the term "pharmaceutically acceptable excipients" includes inert diluents, dispersants and / or granulating agents, surfactants and / or emulsifying agents, disintegrants, binders, preservatives, buffers, lubricants and / or oils. Excipients (such as cocoa butter and suppository wax), coloring agents, coating agents, sweetening agents, flavoring agents and aromatic agents may also be present in the pharmaceutical composition.

[0426] As used herein, the "drug" can be prepared by any method known in pharmacy. Generally, these preparation methods include associating the aforementioned traditional Chinese medicine composition or the aforementioned traditional Chinese medicine extract (i.e., the first active ingredient) with a carrier or excipient and / or one or more other auxiliary components, and then, if necessary and / or desired, shaping and / or packaging the product into the desired single-dose or multi-dose unit.

[0427] The drugs herein can be prepared according to known methods, such as those described in the general rules for preparation in the Chinese Pharmacopoeia, Japanese Pharmacopoeia, United States Pharmacopoeia and European Pharmacopoeia. It depends on the dosage form.

[0428] The traditional Chinese medicine composition described herein can also be made into any conventional dosage form acceptable in pharmacy according to conventional pharmaceutical processes, for example, the preparation processes described in Zhang Zhaowang and Fan Biting's "Pharmaceutics of Traditional Chinese Medicine" (China Traditional Chinese Medicine Press, the 1st edition in January 2002), such as capsules, tablets, granules, powders, oral liquids or pills, etc.

[0429] In the application of the present invention, the pharmaceutical preparation form of the traditional Chinese medicine composition is capsule, tablet, granule, powder, oral liquid or pill. To enable the realization of the above-mentioned forms, pharmaceutically acceptable excipients need to be added during the preparation of these forms, such as: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, matrices, etc. Fillers include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silicon dioxide, etc.; suspending agents include: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include, starch paste, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.; sweeteners include: sodium saccharin, aspartame, sucrose, sodium cyclamate, glycyrrhetinic acid, etc.; flavoring agents include: sweeteners and various flavors; preservatives include: parabens, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chlorhexidine acetate, eucalyptus oil, etc.; matrices include: PEG6000, PEG4000, beeswax, etc. To enable the realization of the traditional Chinese medicine preparations of the above-mentioned forms, other pharmaceutically acceptable excipients need to be added during the preparation of these forms (excipients recorded in each form in "Traditional Chinese Medicine Pharmaceutics" by Zhang Zhaowang and Fan Biting, China Traditional Chinese Medicine Press, the 1st edition in January 2002).

[0430] In this text, the first active ingredient (i.e., traditional Chinese medicine extract and / or traditional Chinese medicine composition) and pharmaceutically acceptable excipients in the "drug" will vary according to the attributes, body size and / or conditions of the subject being treated and further according to the route of administration of the composition. The drug may contain from 0.1% to 100% (w / w) of the first active ingredient.

[0431] In this text, the "effective amount" refers to the amount sufficient to elicit the desired biological response. The effective amount of the active ingredient of the present invention may vary depending on factors such as: the desired biological endpoint, the pharmacokinetics of the compound, the condition being treated, the mode of administration and the age and health status of the subject. In certain embodiments, the effective amount is a therapeutically effective amount. The effective amount is the amount of the first active ingredient described in the present invention in a single dose. In certain embodiments, the effective amount is the combined amount of the active ingredient described in the present invention in multiple doses.

[0432] As used herein, the term "therapeutically effective amount" means an amount sufficient to provide a therapeutic benefit in the treatment of a disorder or sufficient to delay or minimize one or more symptoms associated with the disorder. A therapeutically effective amount of a traditional Chinese medicine composition or extract thereof means an amount of the therapeutic agent that provides a therapeutic benefit, alone or in combination with other therapies, in the treatment of a disorder. The term "therapeutically effective amount" can encompass an amount that modifies overall therapy, reduces or avoids symptoms, signs or causes of a disorder, and / or enhances the therapeutic efficacy of another therapeutic agent. In certain embodiments, a therapeutically effective amount is an amount sufficient to treat any disease or disorder recited herein.

[0433] As used herein, the term "treatment", unless otherwise indicated, means reversing, ameliorating, alleviating, delaying or slowing a disorder or condition to which the term applies or one or more symptoms of such a disorder or condition, inhibiting the progression of the disorder or condition or one or more symptoms thereof, or preventing the disorder or condition or one or more symptoms thereof. The term "treatment" as used in the invention refers to a treatment act as "treatment" is defined immediately above.

[0434] As used herein, "delay" means that the drugs, compositions and treatment methods provided herein are capable of postponing, impeding or slowing the onset of the disease / symptom, such that the likelihood of early disease / symptom manifestation in a patient or the likelihood of the occurrence of the disease in multiple patients is reduced compared to not using the drugs, compositions or methods provided herein within a given time frame.

[0435] As used herein, "slow down" means that the drugs, compositions and treatment methods provided herein effectively inhibit the progressive deterioration of a disease.

[0436] As used herein, "ameliorate" means that the drug compositions and treatment methods provided herein reduce the disease / symptom and / or improve physical function.

[0437] As used herein, "prevention" means delaying the onset of the disease / symptom, slowing down the progression of the disease / symptom, and / or improving the symptoms of the disease, particularly by administering the drugs and compositions of the present invention to a subject before the occurrence of the disease or symptom to avoid the occurrence of the disease or symptom.

[0438] As used herein, "reducing the risk of occurrence of a disease or symptom in a subject" means that the likelihood of a subject developing a disease or symptom is lower than that of an equivalent control individual, e.g., the subject is administered the drug composition of the present invention and the control is untreated or receives no drug.

[0439] In this text, the "urinary system events" used generally refer to various problems or conditions that may occur in the urinary system, and these problems may include, but are not limited to, infections, stones, tumors, obstructions, etc. Among them, the "events" used may be acute, such as the acute pain caused by urinary tract infection (UTI) or kidney stones, or may be chronic, such as chronic nephritis or prostatic hyperplasia. Urinary system events are not necessarily diseases; they may just be temporary symptoms or signs, such as one-time dysuria.

[0440] In this text, the terms "subject" or "patient" used are well-known in the art and are used interchangeably herein, referring to mammals, including dogs, cats, rats, mice, monkeys, cows, horses, goats, sheep, pigs, camels, and most preferably humans.

[0441] In addition to the preparation methods described above in this text, in this text, the active ingredients or extracts of the traditional Chinese medicine composition can be obtained by conventional extraction processes (such as Zhang Zhaowang, Fan Biting, "Pharmaceutics of Traditional Chinese Medicine", China Press of Traditional Chinese Medicine, January 2002, 1st edition).

[0442] In this text, the described traditional Chinese medicine composition or extract can also be used as one of the raw materials and included in feeds, foods, health products, nutritional products, and medicines.

[0443] In this text, the acceptable excipients or additives for the nutritional products or health products include fillers (such as microcrystalline cellulose, pregelatinized starch, etc., for improving the taste and stability of the product), binders (such as hypromellose, sodium carboxymethylcellulose, etc., for increasing the adhesiveness of granules), disintegrants (such as croscarmellose sodium, crospovidone, etc., for improving the disintegration speed of tablets or capsules), lubricants (such as magnesium stearate, colloidal silicon dioxide, etc., for reducing the friction of granules during pressing), coating agents (such as hypromellose acetate succinate, polyvinyl alcohol, etc., for improving the appearance of the product and controlling release), sweeteners (such as sorbitol, mannitol, etc., for increasing the sweetness of the product), preservatives (such as parabens, sodium benzoate, etc., for extending the shelf life of the product), pigments (such as natural pigments or synthetic pigments, for improving the appearance of the product), flavors (for imparting specific aromas to the product), as well as lubricants and suspending agents, and raw materials and additives that can be used in health foods as specified in the "Catalogue of Raw Materials for Health Foods (2020 Edition)".

[0444] In this text, the "drug content of the decoction / decocted liquid" can be expressed by the "drug content concentration representation method", and examples are as follows: Decocted liquid 3 g / ml (Astragalus membranaceus 9 g, Siphonostegia chinensis 9 g, Typha angustata 12 g, made into 10 ml).

[0445] In this text, the descriptions of the raw materials used in the traditional Chinese medicine composition or traditional Chinese medicine extract are as follows:

[0446] In this article, there are no special requirements for the processing methods of the preparation raw materials, and conventional processing methods can be adopted. Commonly referred to processing methods can be found in the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the Chinese Pharmacopoeia), the traditional Chinese medicine processing specifications of each province, etc. Generally, impurity removal, cleaning, slicing, cutting into sections, drying, or additional treatments such as steaming, soaking, and moistening through are carried out. For example, according to the records of the Chinese Pharmacopoeia:

[0447] Astragalus membranaceus (Fisch.) Bunge var. mongholicus (Bunge) Hsiao & K. C. Hsia or Astragalus membranaceus (Fisch.) Bunge, Leguminosae, dried roots. Tonifying qi and strengthening the spleen, lifting yang and raising prolapse. This product is sweet and warm and is good at entering the spleen and stomach. It is an important herb for tonifying the spleen qi. "Medical Compendium of Chinese and Western Medicine" states that it "can tonify qi, and at the same time can lift qi, and is good at treating the qi in the chest cavity". The representative method for processing Astragalus membranaceus is to remove impurities, separate them by size, wash, moisten through, cut into thick slices, and dry;

[0448] Artemisia anomala S. Moore, Scrophulariaceae, dried whole herb. Having the effects of promoting blood circulation to remove stasis and dredging menstruation by breaking blood. The representative method for processing Artemisia anomala is to remove impurities, wash, cut into sections, and dry;

[0449] Typha angustifolia L., Typha orientalis Presl or pollen of plants of the same genus, Typhaceae. Aliases: Cattail Pollen, Cattail Flower, Pollen of Cattail Spike, Pollen of Cattail Fruit. Having the effects of promoting blood circulation to remove stasis, diuresis, and relieving stranguria. The representative method for processing Typha angustifolia is to break up the lumps and sieve;

[0450] Dioscorea septemloba Thunb., Dioscoreaceae, dried rhizome. Good at expelling wind and relieving arthralgia, promoting diuresis and resolving turbidity. When used in combination with other herbs, it is applicable to lower urinary tract symptoms such as frequent urination, incomplete urination, dysuria, and turbid urine caused by benign prostatic hyperplasia. The representative method for processing Dioscorea septemloba is to remove the fibrous roots, wash, slice, and dry in the sun;

[0451] Bombyx batryticatus, the dried body of the 4th to 5th instar larvae of the silkworm Bombyx mori L. infected (or artificially inoculated) with Beauveria bassiana (Bals.-Criv.) Vuill. The representative method for processing Bombyx batryticatus is to wash and dry, and remove impurities. However, it should be noted that considering the characteristic of Bombyx batryticatus having a fishy smell, it is preferably recommended to use modern processing methods such as stir-frying with bran, soaking and roasting with rice-washing water, stir-frying with glutinous rice, stir-frying with flour, honey-roasting, stir-frying with oil, stir-frying with wine, ginger-roasting, ginger-steaming, etc. The main function is to correct the taste and odor, so as not to damage the stomach qi of the patient, thereby enabling the drug to better exert its curative effect.

[0452] Ecklonia kurome Okamura or Laminaria japonica Aresch., Laminariaceae, dried thallus. The representative method for processing Ecklonia kurome is to remove impurities, rinse thoroughly, air-dry slightly, cut into wide strips, and dry in the sun.

[0453] Ecklonia kurome and Bombyx batryticatus: Both have the function of resolving phlegm and dissipating nodules. When the two herbs are used in combination, the power of resolving phlegm and softening hardness and dissipating nodules is stronger.

[0454] Cinnamomum cassia Presl, Lauraceae, dried bark. Tonifying fire and assisting yang, warming the channels and promoting qi transformation in the lower energizer. The representative method for processing Cinnamomum cassia is to remove impurities and rough bark, and pound before use;

[0455] Rhizoma Curcumae, the dried rhizome of Curcuma phaeocaulis Valeton, Curcuma kwangsiensis S. G. Lee et C. F. Liang or Curcuma wenyujin Y. H. Chen et C. Ling, Zingiberaceae family. It can promote blood circulation to remove blood stasis, activate qi and relieve pain. Both Herba Artemisiae Anomalae and Rhizoma Curcumae are important drugs for promoting blood circulation to remove blood stasis. In the new traditional Chinese medicine formula described in this patent, Herba Artemisiae Anomalae and Rhizoma Curcumae are key drugs targeting the main pathological factor of "blood stasis" in patients with benign prostatic hyperplasia. The representative method for processing Rhizoma Curcumae is to remove impurities, soak it slightly, wash it, steam it until soft, cut it into thick slices, and dry it;

[0456] Plastrum Testudinis, the dorsal and ventral carapaces of the tortoise, Testudinidae family. Also known as Carapax et Plastrum Testudinis, it is the carapace of the tortoise, Testudo genus. It has the functions of nourishing yin and suppressing yang, and strengthening the kidneys and bones. Li Shizhen in "Compendium of Materia Medica" said: "Tortoises and deer are spiritual and long-lived. The head of the tortoise is often hidden towards the abdomen, and it can connect with the Conception Vessel which runs through the abdomen. Therefore, taking its abdomen can tonify the heart, nourish the kidneys and enrich the blood, all of which are for nourishing yin." Ye Tianshi in "Medical Records of Clinical Guidelines" said: "The nature of the tortoise is yin and it runs through the Conception Vessel." Therefore, Plastrum Testudinis is the most important guiding drug for the Conception Vessel and can regulate the qi and blood state of the Conception Vessel. The representative method for processing Plastrum Testudinis (Carapax et Plastrum Testudinis) is to place the carapax et plastrum testudinis in a steaming pot, steam it with boiling water for 45 minutes, take it out, put it into hot water, immediately use a stiff brush to remove all the flesh and skin, wash it, and dry it in the sun. In addition, there are also processing methods for Plastrum Testudinis (Carapax et Plastrum Testudinis) such as boiling method, sand roasting method, stewing method, and lime water soaking method. The above are all common methods for processing the pure product of Plastrum Testudinis during the preparation process, and the purpose is to remove the rotten flesh attached to the surface of the medicinal material. During the clinical application process, sand roasting and vinegar quenching can also be added. The specific method is as follows: break the carapax et plastrum testudinis into small pieces, stir-fry it with sand until it is extremely hot, then quickly sieve out the sand and spray it with vinegar. The processed Plastrum Testudinis is the processed Plastrum Testudinis. Compared with the raw Plastrum Testudinis, the extraction rate of protein in the processed Plastrum Testudinis during decocting, boiling and making glue is increased by 4 times. From the perspective of traditional Chinese medicine processing theory, the Plastrum Testudinis after sand roasting and vinegar quenching enhances its power of softening hardness and dissipating nodules. Therefore, it is more suitable for the treatment of benign prostatic hyperplasia.

[0457] Radix Glycyrrhizae, the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L., Leguminosae family. It is sweet and neutral, and is a qi-tonifying drug among the drugs for tonifying deficiency. It has the functions of invigorating the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating pain and harmonizing various drugs. In the new traditional Chinese medicine formula described in this patent, Astragalus membranaceus is the key drug targeting the main pathological factor of "qi deficiency" in patients with benign prostatic hyperplasia. The combination of Radix Glycyrrhizae and Astragalus membranaceus also jointly plays the role of tonifying the spleen qi. At the same time, Radix Glycyrrhizae also plays the role of harmonizing various drugs. The representative method for processing Radix Glycyrrhizae is to remove impurities, wash it, moisten it thoroughly, cut it into thick slices, and dry it.

[0458] Another record shows that Euphorbia helioscopia L., the whole herb of Euphorbia helioscopia L., Euphorbiaceae family. It promotes diuresis and reduces edema, and dissipates phlegm and relieves cough. The representative method for processing it is to remove impurities, wash it, moisten it slightly, cut it into sections, and dry it.

[0459] In addition to the above, all the Chinese medicinal materials used in this article have passed quality inspection. The items of drug inspection include: color of decoction, properties, content determination, impurities, moisture, total ash, acid-insoluble ash, carbon dioxide residue, microscopic identification, thin-layer identification, extractives, and residues of 33 kinds of prohibited pesticides. The basis for drug inspection: Volume I and Volume IV of the Chinese Pharmacopoeia (2020 Edition).

[0460] Based on this, the formula provided by the present invention includes raw materials Astragali Radix, Artemisiae Anomalae Herba, Pollen Typhae, Dioscoreae Hypoglaucae Rhizoma, Bombyx Batryticatus, Laminariae Thallus, Cinnamomi Cortex, Rhizoma Zedoariae, Euphorbiae Helioscopiae Herba, Plastrum Testudinis, and Glycyrrhizae Radix et Rhizoma, which have the best therapeutic effect. On this basis, the reduced-formula formulations (formulation methods of reducing certain drugs), such as removing Cinnamomi Cortex, prepared Plastrum Testudinis, and raw Glycyrrhizae Radix et Rhizoma, and / or Dioscoreae Hypoglaucae Rhizoma and Euphorbiae Helioscopiae Herba, and / or raw Pollen Typhae, will all weaken the overall drug effect and result in poor therapeutic effects.

[0461] The present invention will be described below through specific examples to make the technical solutions of the present invention easier to understand and master. However, the present invention is not limited thereto. The described embodiments are only a part of the embodiments of the present invention, rather than all embodiments. Therefore, they do not impose any limitations on the present invention. Those skilled in the art make some non-essential improvements and adjustments based on the content of the present invention, which all fall within the protection scope of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention. In the following embodiments, the experimental methods are all conventional methods unless otherwise specified; the reagents and materials can be obtained from commercial channels unless otherwise specified. Specific Embodiments

[0463] Example 1

[0464] Raw material formula: 30 g of Astragali Radix, 30 g of Artemisiae Anomalae Herba, 30 g of Pollen Typhae, 20 g of Dioscoreae Hypoglaucae Rhizoma, 15 g of Bombyx Batryticatus, 15 g of Laminariae Thallus, 3 g of Cinnamomi Cortex, 30 g of Rhizoma Zedoariae, 15 g of Euphorbiae Helioscopiae Herba, 6 g of Plastrum Testudinis, and 6 g of Glycyrrhizae Radix et Rhizoma.

[0465] Preparation method: Step 1) Compatibility of each Chinese medicinal material that has passed quality inspection according to the proportion, soak in pure water for 30 minutes, and the water addition amount should exceed the drug surface by 2 - 3 cm;

[0466] Step 2) Decoct twice successively with a decocting pot, decoct for 1 hour for the first time and 30 minutes for the second time;

[0467] Step 3) Combine the water decoctions of the two times, filter, and concentrate the filtrate to obtain.

[0468] Example 2

[0469] Raw material formula: 60 g of Astragalus membranaceus, 60 g of Siphonostegia chinensis, 60 g of Typha angustifolia, 40 g of Dioscorea septemloba, 30 g of Bombyx batryticatus, 30 g of Ecklonia kurome, 6 g of Cinnamomum cassia, 60 g of Curcuma zedoaria, 30 g of Euphorbia helioscopia, 12 g of Plastron carapacis, 12 g of Glycyrrhiza uralensis.

[0470] Preparation method: Step 1) Compatibility of each qualified Chinese medicinal material according to the proportion, soak in pure water for 30 minutes, and the water addition amount should exceed the drug surface by 2 - 3 cm;

[0471] Step 2) Decoct twice successively with a decocting pot, decoct for 1 hour for the first time and 30 minutes for the second time;

[0472] Step 3) Combine the water decoction liquids of the two times, filter, and concentrate the filtrate to obtain.

[0473] Example 3

[0474] Raw material formula: 10 g of Astragalus membranaceus, 10 g of Siphonostegia chinensis, 10 g of Typha angustifolia, 5 g of Dioscorea septemloba, 5 g of Bombyx batryticatus, 5 g of Ecklonia kurome, 1 g of Cinnamomum cassia, 10 g of Curcuma zedoaria, 5 g of Euphorbia helioscopia, 2 g of Plastron carapacis, 2 g of Glycyrrhiza uralensis.

[0475] Preparation method: Step 1) Pulverize each qualified Chinese medicinal material into medicinal powder;

[0476] Step 2) Mix the medicinal powder and the binder evenly and knead into a soft and hard appropriate mass;

[0477] Step 3) Extrude the mass into uniform pill strips and cut into uniform pill grains.

[0478] Example 4

[0479] Raw material formula: 25 g of Astragalus membranaceus, 25 g of Siphonostegia chinensis, 25 g of Typha angustifolia, 18 g of Dioscorea septemloba, 13 g of Bombyx batryticatus, 13 g of Ecklonia kurome, 1.5 g of Cinnamomum cassia, 25 g of Curcuma zedoaria, 13 g of Euphorbia helioscopia, 3 g of Plastron carapacis, 3 g of Glycyrrhiza uralensis.

[0480] Preparation method: Step 1) Carry out percolation extraction on each qualified Chinese medicinal material with water for 2 times, 40 minutes each time, combine the extraction liquids, and filter the extraction liquids;

[0481] Step 2) Concentrate and purify the filtered extraction liquid;

[0482] Step 3) Add appropriate excipients to the purified concentrated liquid, dry and form it into an ointment.

[0483] Example 5

[0484] Raw material formula: 23 g of Astragalus membranaceus, 23 g of Siphonostegia chinensis, 23 g of Typha angustifolia, 15 g of Dioscorea septemloba, 12 g of Bombyx batryticatus, 12 g of Ecklonia kurome, 1 g of Cinnamomum cassia, 23 g of Curcuma zedoaria, 12 g of Euphorbia helioscopia, 2 g of Plastron carapacis, 2 g of Glycyrrhiza uralensis.

[0485] Preparation method: Step 1) Add water to each qualified Chinese medicinal material through quality inspection and perform ultrasonic extraction twice, each time for 40 minutes. Combine the extraction solutions and filter the extraction solution.

[0486] Step 2) Concentrate and purify the filtered extraction solution.

[0487] Step 3) Add tablet excipients to the purified concentrated solution to make tablets.

[0488] Example 6

[0489] Raw material formula: 15 g of Astragalus membranaceus, 15 g of Siphonostegia chinensis, 15 g of Typha angustifolia, 10 g of Dioscorea septemloba, 8 g of Bombyx batryticatus, 8 g of Ecklonia kurome, 2 g of Cinnamomum cassia, 15 g of Curcuma zedoaria, 8 g of Euphorbia helioscopia, 3 g of Plastrum Testudinis, 3 g of Glycyrrhiza uralensis.

[0490] Preparation method: Step 1) Add water to each qualified Chinese medicinal material through quality inspection and perform ultrasonic extraction twice, each time for 40 minutes. Combine the extraction solutions and filter the extraction solution.

[0491] Step 2) Concentrate and purify the filtered extraction solution.

[0492] Step 3) Purified concentrated capsules.

[0493] Example 7

[0494] 1. Experimental animals and modeling drugs

[0495] (1.1) Experimental animals: 1 SD white male rat of Specific pathogen free (SPF) level, certificate number SCXK (Beijing) 2021-0006. The body weight was between 220 g and 250 g when purchased. It was raised in a standardized barrier environment animal room at a room temperature of 22 - 25 °C and a relative humidity of 50% - 60%. This experiment was approved by the Experimental Animal Welfare and Ethics Committee of the First Clinical Medical College of Beijing University of Chinese Medicine (No. 23-05-01).

[0496] (1.2) Modeling drug: Testosterone propionate injection, specification (concentration): 1 ml: 50 mg; packaging: 1 ml / branch × 10 branches / box; manufacturer: Harbin Sanma Veterinary Pharmaceutical Co., Ltd.; production batch number: 20220502; certificate number: (2018) Veterinary GMP Certificate No. 08006, approval number: Veterinary Drug No. 080231055.

[0497] (1.3) Modeling:

[0498] Refer to the "Specification for the Preparation of Benign Prostatic Hyperplasia Animal Models (Draft)" issued by the "Professional Committee of Traditional Chinese Medicine Experimental Pharmacology, China Association of Chinese Medicine" in 2018 for the establishment of the benign prostatic hyperplasia (BPH) model. Specifically: A non-castrated subcutaneous injection of testosterone propionate is used to induce an animal model of benign prostatic hyperplasia. The specific operation method is as follows: Inject testosterone propionate injection (50 mg·kg -1 ) subcutaneously in the back of the rat's neck every other day for 28 consecutive days, and the dosing mass concentration is 0.001 ml·g -1 ; In the following blank group (labeled as the Control group), inject the same dose of olive oil subcutaneously at the same position, and the time and number of subcutaneous injections are the same as those in the model group.

[0499] 2. Intervention drugs

[0500] (2.1) Use of drugs

[0501] Equal-dose Chinese medicine group (YQHX-D): The decoction prepared according to Example 1, and the crude drug content of the decoction is 1.8 g / ml;

[0502] High-dose Chinese medicine group (YQHX-G): The decoction prepared according to Example 2, and the crude drug content of the decoction is 3.6 g / ml;

[0503] Positive drug control group (Finasteride): Grind finasteride tablets into powder and prepare a solution with a concentration of 0.045 mg / ml using pure water.

[0504] (2.2) Explanation of the dose conversion of the intervention drugs

[0505] Chinese medicine group (equal-dose Chinese medicine group, high-dose Chinese medicine group): The dose of taking Chinese medicine decoction by adults is 1 dose per day for oral administration. The total amount of crude drugs in the new Chinese medicine formula studied in this example is 200 g;

[0506] The gavage volume for rats is 1 ml / 100 g (decoction / rat). The clinical equivalent dose of rats in the equal-dose Chinese medicine group = 200 g / 70 kg × 6.3 = 18 g / kg = 1.8 g / 100 g (crude drug); Therefore, the dosing concentration of the equal-dose Chinese medicine group is: Each 1 ml of the decoction contains 1.8 g of crude drug; Similarly, the high-dose Chinese medicine group is twice the clinical equivalent dose. Therefore, the dosing concentration of the high-dose Chinese medicine group is that each 1 ml of the decoction contains 3.6 g of crude drug;

[0507] Finasteride tablets used in the positive drug control group: English name: Finasteride; Trade name: Proscar; Specification: 5 mg; Packaging: 10 tablets / box; Manufacturer: AIAC International Pharma LLC (Puerto Rico); Import Drug Registration Certificate Number: H20160290; Approval Number: National Medicine Standard J20150143.

[0508] The human dosage of finasteride tablets for the treatment of BPH is 5 mg orally per day. Therefore, the clinical equivalent dose for rats = 5 mg / 70 kg × 6.3 = 0.45 mg / Kg = 0.045 mg / 100 g; the rat gavage volume is 1 ml / 100 g, therefore, the dosing concentration of finasteride is 0.045 mg / ml.

[0509] 3. Experimental grouping and model preparation

[0510] (3.1) Experimental groups

[0511] After the experimental rats were purchased, ear tags were inserted one by one. After adaptive feeding, the experimental rats were randomly divided into a blank group (marked as Control group), a model group (marked as Model group), a positive drug control group (marked as Finasteride group), a Chinese medicine equal dose group (marked as YQHX-D group), and a Chinese medicine high dose group (marked as YQHX-G group), with 6 rats in each group.

[0512] (3.2) Group intervention

[0513] The positive drug control group (labeled as Finasteride group) was given finasteride suspension by gavage;

[0514] The Chinese medicine equal dose group (labeled as YQHX-D group) and the Chinese medicine high dose group (labeled as YQHX-G group) were given Chinese medicine decoction of corresponding concentrations by gavage;

[0515] The blank group and the model group were given the same dose of pure water by gavage;

[0516] The above groups were weighed and gavaged at a fixed time every day, once a day, for 4 consecutive weeks.

[0517] (3.3) Obtaining materials

[0518] Fix the anesthetized rats on the rat board. Incise the entire abdominal wall along the midline of the lower abdomen. After exposing the abdominal aorta, collect blood sample specimens using a small blood collection needle and a blood collection tube containing anticoagulant. Be careful during laparotomy and blood collection to avoid damaging the prostate. After the whole blood sample is left standing at room temperature for 30 minutes, centrifuge it at 3500 r / min for 20 minutes. Aliquot the blood sample specimens into cryotubes, first store them in a -20°C refrigerator, and then transfer them to an -80°C refrigerator for storage. Place the rats after blood collection on an ice plate, incise the lower abdomen to the pubic symphysis to fully expose the abdominal organs. First, find the bladder and seminal vesicles. Using the bladder neck as an anatomical landmark, pull upward to expose the left and right ventral lobes of the prostate. After fully showing the boundaries of the ventral lobes of the prostate, use tissue scissors to cut its connections with the surrounding fascia and muscles. Use small curved forceps for delicate operation to remove the excess adipose tissue around the prostate tissue. Through delicate operation, completely free the left and right ventral lobes of the prostate, place them in PBS buffer for rinsing, dry the excess moisture on the tissue surface with absorbent paper, weigh them on an electronic balance, and place them at the scale for photography. The above operations are all carried out on ice. After photographing the gross tissue, fix the intact left ventral lobe in 4% paraformaldehyde solution for 72 hours and store it in a 4°C refrigerator. Divide the right ventral lobe into 3 equal parts with tissue scissors, place them in cryotubes, and store them in liquid nitrogen.

[0519] (3.4) Serum liver and kidney function tests

[0520] Use the Beckman Coulter AU5800 biochemical analysis system to detect the biochemical indicators of the centrifuged serum. The main purpose is to evaluate the effects of intervention errors involved in the experimental results on the liver and kidney functions of the experimental rats, specifically including: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine (CREA).

[0521] (3.5) Histomorphological examination

[0522] (3.5.1) Small animal ultrasound examination

[0523] After the last administration, the rats in each group were fasted but allowed to drink water. After 8 hours, small animal ultrasound examinations were performed on the experimental rats in each group. The ultrasonic cross-sectional data of the prostate of each rat were measured one by one, and the image data of the ultrasonic cross-section were retained. The specific operation of rat prostate ultrasound was carried out under the guidance of the teachers in the small animal ultrasound room of the Key Laboratory of the Ministry of Education. At the same time, the methods in the literature of Mário Ginja (GINJAM, PIRES M J, GONZALO-ORDEN J M, et al. Anatomy and Imaging of Rat Prostate: Practical Monitoring in Experimental Cancer-Induced Protocols[J]. Diagnostics (Basel), 2019, 9(3).) et al. [2] and Liu Chengcheng (Liu Chengcheng, Han Guangwei, Shang Yonggang, et al. Discussion on Establishing a Rat Model of Chronic Bacterial Prostatitis by Fine Needle Puncture Injection of Escherichia coli under Ultrasonic Guidance[J]. Acta Academiae Medicinae Militaris Tertiae, 2015, 37(19): 1981-1984.) et al. were referred to: A 2.5 ml sterile syringe was used to draw 1% sodium pentobarbital solution. The needle was inserted into the abdominal skin of the rat at an angle of 30°. After aspiration of no liquid, it was injected into the rat abdominal cavity at a dose of 0.5 ml / 100 g; after proper anesthesia, the head and limbs of the rat were fixed. The hair on the lower abdomen, groin and side of the tail of the rat was carefully removed with a small animal special hair clipper; after skin preparation, it was transferred to the operation table of the small animal ultrasound instrument, the limbs of the rat were fixed, the lower abdomen and groin area were fully exposed, and ultrasonic gel was evenly applied. The right hand operated the ultrasonic probe, and a complete cross-sectional scan was performed from top to bottom with the lower abdomen area of the rat as the acoustic window. After the complete seminal vesicle and ventral lobe of the rat prostate were displayed on the ultrasonic monitor, the ultrasonic section was fixed; the ultrasonic cross-sectional data of the prostate of normal rats and the model group rats were observed and measured.

[0524] (3.5.2) Prostate wet weight and index

[0525] Before sampling, the rats were weighed and the weight of each rat was recorded; after sampling, the completely free and rinsed ventral lobe was weighed to obtain the wet weight of the ventral lobe of the prostate; Prostate index (PI) = prostate wet weight / rat body weight × 100%.

[0526] (3.5.3) Prostate pathological observation

[0527] Hematoxylin-eosin (HE) staining was used to observe the morphological changes of the left ventral lobe of the prostate. The specific steps are as follows:

[0528] (1) Dehydration: The left ventral lobe was taken out of the fixing solution, placed in a dehydration box, and put into a dehydrator for dehydration with gradient alcohol in turn;

[0529] (2) Embedding: Embed the wax-impregnated tissue in an embedding machine. First, put the melted wax into the embedding frame. Before the wax solidifies, take the tissue out of the dehydration box and put it into the embedding frame, then cool it on a -20°C freezing table. After the wax solidifies, take out the wax block from the embedding frame and trim the wax block;

[0530] (3) Sectioning: Put the trimmed wax block on a -20°C freezing table to cool, then place the cooled wax block on a paraffin slicing machine to slice, with a thickness of 4μm. Float the slices on the warm water at 40°C on a spreading machine to flatten the tissue, pick up the tissue with a glass slide, and bake the slide in an oven at 60°C for 2 hours to dry the water and melt the wax;

[0531] (4) Dewaxing: Put the slices into environmentally friendly dewaxing solution Ⅰ for 20 minutes - environmentally friendly dewaxing solution Ⅱ for 20 minutes - absolute ethanol Ⅰ for 5 minutes - absolute ethanol Ⅱ for 5 minutes - 75% alcohol for 5 minutes in sequence, and wash with tap water;

[0532] (5) Hematoxylin staining: Put the slices into hematoxylin staining solution and stain for 3 - 5 minutes, wash with tap water, differentiate with a differentiating solution, wash with tap water, blue with a bluing solution, and rinse with running water;

[0533] (6) Eosin staining: Put the slices into 85% and 95% gradient alcohols for dehydration for 5 minutes each in sequence, and then stain in eosin staining solution for 5 minutes;

[0534] (7) Dehydration and mounting: Put the slices into absolute ethanol I for 5 minutes - absolute ethanol II for 5 minutes - absolute ethanol III for 5 minutes - xylene I for 5 minutes - xylene II for 5 minutes in sequence for clearing, and mount with neutral balsam;

[0535] (8) Observation: Observe the tissue-stained sections under an optical microscope and take pictures.

[0536] (3.5.4) Statistical methods

[0537] In this study, SPSS 25.0 was used for data analysis and GraphPad Prism V 9.0 was used for graphing. Quantitative data were described as mean ± standard deviation. Independent sample t-tests were used for comparing normally distributed data between two groups, and one-way ANOVA was used for multiple groups of normal data. When comparing pairwise between groups with homogeneous variances, Bonferroni tests were used, and when comparing pairwise between groups with heterogeneous variances, Games-Howell tests were used. For those that did not conform, rank sum and non-parametric tests were used. P < 0.05 was considered statistically significant.

[0538] 4. Experimental results

[0539] (1) Basic conditions of experimental rats

[0540] After the experimental rats were randomly grouped, there were 6 rats in each group, and there was no significant difference in the body weights of the rats among the groups. During the experiment, the body weights of the rats in each group increased steadily with the number of weeks, they ate and drank freely and stably, and their hair coats had luster. Compared with the Control group, the rats in the Model group had increased water intake and wetter bedding after subcutaneous injection of testosterone propionate injection. From the results of the body weight changes, it can be seen that the average body weight of the rats in the Model group was lower than that in the Control group; the average growth rate of the body weight in the Model group was lower than that in the Control group; in addition, the body weight increase in the YQHX-G group was the smallest. See Table 1 for details.

[0541] Table 1 Changes in the body weights of rats in each group during the experimental period (g)( n = 6)

[0542] Group The 2nd week The 4th week The 6th week The 8th week Control 351.3±11.3 395.7±9.9 457.0±11.4 497.2±29.1 Model 323.9±12.0 347.8±18.6 398.4±20.9 450.4±29.4 Finasteride 325.3±19.6 348.0±21.5 414.9±45.6 458.7±43.2 YQHX-D 326.5±21.4 350.1±18.7 411.6±34.7 458.8±37.1 YQHX-G 327.9±5.9 348.9±9.5 401.6±23.7 429.5±31.9

[0543] *Note: Control: blank group; Model: model group; Finasteride: positive drug control group (finasteride); YQHX-D: equal-dose group of new traditional Chinese medicine formula; YQHX-G: high-dose group of new traditional Chinese medicine formula

[0544] (2) Serum liver and kidney functions of experimental rats

[0545] The test results of the serum liver and kidney functions of the rats in each group showed (Table 2, Figure 1 ), and there was no significant difference in the core indicators of liver function (ALT and AST) and the core indicator of kidney function (CREA) among the groups (P > 0.05).

[0546] Table 2 Serum liver and kidney functions of rats in each group n = 6)

[0547]

[0548]

[0549] In summary, through the pharmacodynamic experimental results of the body weights of the rats and the serum liver and kidney functions of the rats, it is shown that the water decoction of the traditional Chinese medicine composition provided in the embodiment of the present invention has high drug safety and does not cause abnormalities in the liver and kidney functions of the experimental rats.

[0550] (3) Prostate ultrasound and gross photos of experimental rats

[0551] After the grouping intervention treatment was completed, a dedicated small animal ultrasound instrument was used to detect the lower abdomen of each experimental rat. The prostate anatomical structure and its surrounding tissues of the experimental rat were identified under ultrasound, and the areas of the cross-sections of the left and right ventral lobes of the prostate were measured (as shown in Table 3, Figure 2 , Figure 3As shown). From the results of small animal ultrasound examination, the bladder is round or oval. The bladders of some experimental mice are full of urine. The inside of the bladder shows a clear echo-free structure area (marked with *), and the ventral lobe of the prostate can be seen around the bladder (thick arrow → indicated). The ventral lobe of the prostate appears as a low-echo oval structure, roughly symmetrical on both sides, with a high-echo capsule located on the ventral side of the bladder. In addition, the seminal vesicle structure (marked with △) can be clearly observed on ultrasound. It is located on the dorsal side of the bladder. The seminal vesicle appears as a slender low-echo structure on ultrasound imaging. Compared with the ventral lobe of the prostate, the seminal vesicle has less low echo. Because the seminal vesicle wraps part of the condensation gland, the seminal vesicle and the condensation gland cannot be completely distinguished from each other on ultrasound imaging.

[0552] Ultrasound imaging showed that compared with the Control group, the cross-sectional area of ​​the left and right ventral lobes of the prostate in the Model group was significantly larger (P<0.0001), and the echo was uneven, which was mainly manifested in the denser "point-like" high echoes inside the ventral lobe of the prostate in the Model group (Figure X). Compared with the Model group, the cross-sectional area of ​​the Finasteride group, the YQHX-D group, and the YQHX-G group was significantly reduced (P<0.0001), the point-like high echoes decreased, and the distribution density decreased (Figure X); there was no statistically significant difference between the YQHX-D group and the YQHX-G group (P>0.05).

[0553] Table 3 Ultrasound cross-sectional area of ​​the ventral lobe of the prostate of rats in each group (mm 2 )( n=6)

[0554] Group Left ventral lobe (VP-L-Area) Right ventral lobe (VP-R-Area) Control 19.73±2.29 20.10±2.28 Model 32.70±3.42 33.14±4.37 Finasteride 19.10±2.64 18.62±3.35 YQHX-D 20.34±2.62 20.99±2.38 YQHX-G 18.99±2.28 17.93±3.93

[0555] After the small animal ultrasound examination was completed, the prostate tissue specimens of the experimental rats were further obtained and photographed (e.g. Figure 4 The results show:

[0556] The ventral lobe of the prostate gland in the control group experimental rats was light pink, soft and shiny, and the surface of the gland was covered with a thin and transparent membrane, which was wrapped with varying degrees of fat and connective tissue. We removed excess fat and connective tissue during the sampling process.

[0557] Compared with the Control group, the Model group showed fuller glandular tissue, and the tiny blood vessels on the surface of the glands were clearly visible;

[0558] Compared with the Model group, the glands of the mice in the Finasteride group, YQHX-D group, and YQHX-G group were reduced in size to varying degrees, but the overall color of the glands was darker and the glossiness was poorer;

[0559] In terms of the size visible to the naked eye, the Finasteride group shrank the most significantly, but its surface was not smooth and its overall shape was irregular; compared with the Finasteride group, the glands in the traditional Chinese medicine treatment group were relatively intact and their shape was more regular;

[0560] From the perspective of gross specimens, there were no obvious differences between the YQHX-D group and the YQHX-G group.

[0561] In summary, in this embodiment, small animal ultrasound was used to evaluate the curative effect, realizing the monitoring of the structure, size and shape of the rat prostate in vivo, providing more evaluation methods for prostate-related animal experiments, and further confirming from the perspective of imaging that the traditional Chinese medicine composition decoction provided in the embodiment of the present invention can effectively treat benign prostatic hyperplasia.

[0562] (4) Comparison of the wet weight and index of the prostate of experimental rats

[0563] The wet weight and index of the prostate of rats in each group are shown in the following table (as shown in Table 4, Figure 5 shown). Compared with the Control group, the wet weight of the prostate and the prostate index (PI) of rats in the Model group were significantly increased (P<0.0001);

[0564] Compared with the Model group, the wet weight of the prostate and PI in the Finasteride group, YQHX-D group and YQHX-G group were all significantly decreased: among them, the Finasteride group decreased the most significantly (P<0.0001), followed by the YQHX-G group (P<0.001) and the YQHX-D group (P<0.01); there was no significant difference between the YQHX-D group and the YQHX-G group (P>0.05).

[0565] Table 4 Wet weight and index of the prostate of experimental rats in each group ( n = 6)

[0566]

[0567]

[0568] In summary, it can be seen that the traditional Chinese medicine composition decoction provided in the embodiment of the present invention has a significant curative effect on rats with benign prostatic hyperplasia model, can significantly reduce the wet weight and index of the prostate of rats with hyperplasia model, can maintain the normal secretory function of glandular epithelial cells, and has an improvement effect on both glandular hyperplasia and interstitial hyperplasia of the prostate.

[0569] (5) Histopathological comparison of the prostate of experimental rats

[0570] Control group: The ventral lobe of the rat prostate consists of alveoli of varying sizes. The glandular structure is intact, the outline of the glandular lumen is regular and flat, with very few internal foldings, surrounded by a small amount of smooth muscle, and contains pale eosinophilic serous fluid and flocculent secretions; the glandular epithelium is normal in morphology and neatly arranged. The epithelial cells are monolayer cuboidal or short columnar, loose and orderly, with normal morphological structure, no obvious protrusions, and no obvious nucleoli; there is little interstitial connective tissue.

[0571] Model group: The glandular structure is disordered, the capsule is thickened, the outline of the glandular lumen fluctuates significantly, and individual glandular epithelial cells are tall columnar or flattened, with increased density, arranged in multiple layers, showing stratified or pseudostratified in many places, and many clustered and papillary internal foldings can be seen, protruding into the glandular lumen; the epithelial cells secrete vigorously; the overall tissue morphology of the Model group shows complex hyperplasia with multifocal lesions, and vacuole distribution can be seen in some parts; the interstitial blood vessels are dilated and congested, and the connective tissue components in the interstitium are significantly increased.

[0572] Finasteride group: The tissue of the ventral lobe of the prostate after finasteride intervention still has a very disordered glandular structure, the outline of the glandular lumen is irregular, most of the alveoli show an atrophic state, the epithelial cells are irregular, darkly stained, showing degenerative manifestations, the space between alveoli is large, and there is chronic inflammatory infiltration around, the distribution of vacuoles is significantly increased, and fibromuscular components can be seen increasing in the interstitium.

[0573] YQHX-D group and YQHX-G group: The prostate tissue after intervention with traditional Chinese medicine decoction machine. Most of the alveolar lumens are full, with scattered vacuole distribution, and basically return to the state of normal tissue structure. The epithelial cells return to cuboidal and columnar shapes, and the phenomenon of disordered arrangement has been improved to varying degrees, much more regular than the Model group. The number of glandular epithelial cells is significantly reduced, the papillary internal foldings in the alveoli are significantly less, the inner surface of the glandular lumen is smooth, the space between most alveoli is smaller than that of the Model group, and the connective tissue components in the interstitium are significantly reduced.

[0574] In summary, it can be seen that compared with the Finasteride group, the traditional Chinese medicine composition decoction provided in the embodiments of the present invention shows significant curative effects on rats with benign prostatic hyperplasia models, and the improvement effect in pathology is better than that of the Finasteride group. The main manifestations are that a large number of glandular epithelial atrophy and loss of secretory function occur in the prostate of rats in the Finasteride group; while the improvement effect of the traditional Chinese medicine composition decoction provided in the embodiments of the present invention on the interstitial components of the rat prostate is better than that of finasteride in the Finasteride group.

Claims

1. A Chinese medicine composition, wherein the Chinese medicine composition is made of the following raw materials in parts by weight:

2. A Chinese medicine composition, wherein the Chinese medicine composition is made of the following raw materials in parts by weight:

3. A Chinese medicine composition, calculated by weight, comprising the following raw materials:

4. A Chinese medicine composition, which is made from the following raw materials in parts by weight:

5. A Chinese medicine extract, characterized in that: The extract is prepared from raw materials for preparing the Chinese medicine composition according to any one of claims 1 to 4.

6. A Chinese medicine extract, characterized in that: The Chinese medicine extract comprises active ingredients: extract of astragalus, extract of northern liujiu, extract of pollen typhae, extract of schisandra chinensis, extract of bombyx batryticatus, extract of kelp, extract of zedoaria, extract of cinnamon bark, extract of lacquer, extract of tortoise shell, and extract of liquorice.

7. The Chinese herbal medicine extract according to claim 6, characterized in that: The extract comprises any one or both of a water extract and an alcohol extract.

8. A drug, characterized in that The medicine comprises the Chinese medicine composition according to any one of claims 1 to 4, or the Chinese medicine extract according to any one of claims 5 to 7.

9. A health product, characterized in that: The health care product comprises the Chinese medicine composition according to any one of claims 1 to 4, or the Chinese medicine extract according to any one of claims 5 to 7.

10. A nutritional product, characterized in that: The nutritional product comprises the Chinese medicine composition according to any one of claims 1 to 4, or the Chinese medicine extract according to any one of claims 5 to 7.

11. Use of the Chinese medicine composition according to any one of claims 1 to 4, or the Chinese medicine extract according to any one of claims 5 to 7, in the preparation of a medicine or health product or nutritional product for preventing and / or controlling and / or treating benign prostatic hyperplasia or urinary system events.

12. Use of the Chinese medicine composition according to any one of claims 1 to 4, or the Chinese medicine extract according to any one of claims 5 to 7, in the preparation of a medicine or health product or nutritional product for preventing and / or controlling and / or treating any of the following aspects: Prostate hyperplasia; and / or, Benign prostatic hyperplasia; and / or, Disease characterized by increased prostate wet weight; and / or, Disease characterized by an increased prostate index; and / or, A disease characterized by hyperplasia of the prostate gland; and / or, Disease characterized by prostatic stromal hyperplasia; and / or, A disease characterized by an increase in the size of the prostate gland; and / or, A disease characterized by an increase in the size of the prostate gland; and / or, A disorder characterized by an increase in the number of transitional zone cells in the prostate; and / or, A disorder characterized by hyperplasia of the glandular area of ​​the prostate; and / or, Disease characterized by hyperplasia of the transitional zone of the prostate; and / or, A disorder characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or, Disorders characterized by smooth muscle hyperplasia of the bladder; and / or, Disorders characterized by bladder outlet obstruction; and / or, Disorders characterized by lower urinary tract symptoms; and / or, Prostate disease characterized by increased prostate wet weight; and / or, Prostate disease characterized by an increased prostate index; and / or, Prostate disease characterized by hyperplasia of the prostate gland; and / or, Prostate disease characterized by prostatic stromal hyperplasia; and / or, Prostate disease characterized by an increase in prostate size; and / or, Prostate disease characterized by an increase in the number of transitional zone cells in the prostate; and / or, Prostate disease characterized by hyperplasia of the glandular area of ​​the prostate; and / or, Prostatic disease characterized by hyperplasia of the transitional zone of the prostate; and / or, Prostate disease characterized by hyperplasia of the glandular epithelial cells of the prostate; and / or, Prostatic disease characterized by hyperplasia of the smooth muscle of the bladder; and / or, Prostatic disease characterized by bladder outlet obstruction; and / or, Prostate disease characterized by lower urinary tract symptoms; and / or, Prostatic hyperplasia characterized by increased prostate wet weight; and / or, Prostatic hyperplasia characterized by an increased prostatic index; and / or, Prostatic hyperplasia characterized by enlargement of the prostate gland; and / or, Prostatic hyperplasia characterized by prostatic stromal hyperplasia; and / or, Prostatic hyperplasia, characterized by an increase in the size of the prostate; and / or, Prostatic hyperplasia characterized by an increase in the number of cells in the transitional zone of the prostate; and / or, Prostatic hyperplasia characterized by an increase in the glandular area of ​​the prostate; and / or, Prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or, Prostatic hyperplasia characterized by proliferation of the glandular epithelial cells of the prostate; and / or, Prostatic hyperplasia characterized by hyperplasia of the smooth muscles of the bladder; and / or, Prostatic hyperplasia characterized by bladder outlet obstruction; and / or, Prostatic hyperplasia characterized by lower urinary tract symptoms; and / or, Benign prostatic hyperplasia characterized by increased prostate wet weight; and / or, Benign prostatic hyperplasia characterized by an increased prostatic index; and / or, Benign prostatic hyperplasia, characterized by enlargement of the prostate gland; and / or, Benign prostatic hyperplasia characterized by prostatic stromal hyperplasia; and / or, benign prostatic hyperplasia, characterized by an increase in the size of the prostate; and / or, Benign prostatic hyperplasia, characterized by an increase in the number of cells in the transitional zone of the prostate; and / or, benign prostatic hyperplasia characterized by hyperplasia of the glandular zone of the prostate; and / or, benign prostatic hyperplasia characterized by hyperplasia of the transitional zone of the prostate; and / or, Benign prostatic hyperplasia, characterized by proliferation of the glandular epithelial cells of the prostate; and / or, Benign prostatic hyperplasia characterized by hyperplasia of the smooth muscle of the bladder; and / or, Benign prostatic hyperplasia characterized by bladder outlet obstruction; and / or, Benign prostatic hyperplasia characterized by lower urinary tract symptoms; and / or, Urinary events.

13. The Chinese medicine composition according to any one of claims 1 to 4, or the Chinese medicine extract according to any one of claims 5 to 7, or the medicine according to any one of claims 8, 11 to 12, or the health care product according to any one of claims 9, 11 to 12, or the nutritional product according to any one of claims 10, 11 to 12, characterized in that: The dosage forms of the Chinese medicine composition, the Chinese medicine extract, the medicine, the health product, or the nutrient include powders, granules, tablets, pills, capsules, suspensions, lozenges, granules, ointments, syrups, oral liquids, creams, drops, suppositories, emulsions, patches, or plasters.

14. The Chinese medicine composition according to any one of claims 1 to 4, or the Chinese medicine extract according to any one of claims 5 to 7, or the medicine according to any one of claims 8, 11 to 12, or the health care product according to any one of claims 9, 11 to 12, or the nutritional product according to any one of claims 10, 11 to 12, characterized in that: For oral use or skin application.

15. The preparation of the Chinese medicine composition according to any one of claims 1 to 4, 13 to 14, or the Chinese medicine extract according to any one of claims 5 to 7, 13 to 14, or the medicine according to any one of claims 8, 11 to 14, or the health care product according to any one of claims 9, 11 to 14, or the nutritional product according to any one of claims 10 to 14, comprising the steps of: mixing the raw materials according to the amount, soaking them in a solvent, and decocting them.

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