A composition for inhibiting prostatic hyperplasia and its preparation and use

Abstract

This invention provides a composition for inhibiting benign prostatic hyperplasia (BPH), its preparation method, and its application, relating to the field of pharmaceutical technology. The composition comprises the following raw materials in parts by weight: 1-4 parts of processed Polygonum multiflorum, 1-4 parts of Ganoderma lucidum, 0.505-2.02 parts of Morinda officinalis, 1.54-4.55 parts of Polygonatum sibiricum, and 0.5-2 parts of Panax notoginseng. By utilizing the synergistic effect of processed Polygonum multiflorum, Ganoderma lucidum, Morinda officinalis, and Polygonatum sibiricum to nourish the liver and kidneys, and working synergistically with Panax notoginseng to promote blood circulation and remove blood stasis, the raw materials exhibit a synergistic effect, achieving the functions of tonifying the kidneys, promoting blood circulation and removing blood stasis, and anti-aging. It can effectively inhibit the growth of BPH-1 cells, improve benign prostatic hyperplasia, and significantly enhance the inhibitory effect on BPH. Furthermore, none of the raw materials have any toxic side effects, making them suitable for long-term use.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a composition for inhibiting benign prostatic hyperplasia, its preparation method, and its application. Background Technology

[0002] Benign prostatic hyperplasia (BPH) is a typical chronic disease of the elderly, commonly affecting men over 40 years of age. Clinically, it mainly manifests as lower urinary tract symptoms such as urinary frequency and difficulty urinating. With the increasing aging of the global population, the incidence of BPH is generally on the rise, with a prevalence of nearly 40% in the 50-79 age group and exceeding 80% in the 80-year-old age group.

[0003] With the improvement of living standards and the progress of health care, the average life expectancy of humans has been continuously extended, and the aging population in countries around the world is increasing day by day. The incidence of aging is rising, which seriously affects the physical and mental health and quality of life of middle-aged and elderly men and has become a major disease of universal international concern.

[0004] Currently, the main clinical treatments for BPH include Western medicine, minimally invasive treatment, and surgery. However, the Western medicines on the market all have certain deficiencies in terms of tolerability. For example, tamsulosin can cause retrograde ejaculation, finasteride can cause breast hyperplasia, and sildenafil can cause visual impairment. Minimally invasive treatment and surgery not only have high recurrence rates but can also cause erectile dysfunction in patients. Traditional Chinese medicine combinations are gradually being used in clinical practice due to their advantages such as fewer toxic side effects.

[0005] Chinese patent document CN111375022A discloses a traditional Chinese medicine composition for treating benign prostatic hyperplasia. The active ingredients of this composition are American ginseng, astragalus, wolfberry, polygonatum, notoginseng, and licorice. Animal experiments on mice have shown that it has the effect of improving benign prostatic hyperplasia. However, the amount of American ginseng in this composition is relatively large and the price of this raw material is high, which increases the medical cost for consumers.

[0006] In view of this, the present invention is hereby proposed. Summary of the Invention

[0007] One of the objectives of this invention is to provide a composition that inhibits benign prostatic hyperplasia (BPH), thereby at least addressing the technical problems of toxic side effects, low quality and safety of minimally invasive treatments and surgeries in the prior art for improving BPH.

[0008] A second objective of this invention is to provide an extract that inhibits benign prostatic hyperplasia.

[0009] A third objective of this invention is to provide a method for preparing an extract that inhibits benign prostatic hyperplasia.

[0010] The fourth objective of this invention is to provide the application of the above-mentioned extract or the extract prepared by the above-mentioned preparation method in the preparation of products that inhibit benign prostatic hyperplasia.

[0011] The fifth objective of this invention is to provide a drug for inhibiting benign prostatic hyperplasia.

[0012] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted:

[0013] In a first aspect, the present invention provides a composition for inhibiting benign prostatic hyperplasia, comprising the following raw materials in parts by weight: 1-4 parts of processed Polygonum multiflorum, 1-4 parts of Ganoderma lucidum, 0.505-2.02 parts of Morinda officinalis, 1.54-4.55 parts of Polygonatum sibiricum, and 0.5-2 parts of Panax notoginseng.

[0014] Furthermore, the ingredients include the following parts by weight: 1-2 parts of processed Polygonum multiflorum, 3.35-4 parts of Ganoderma lucidum, 0.505-1.01 parts of Morinda officinalis, 3.2-4.55 parts of Polygonatum sibiricum, and 0.5-1 parts of Panax notoginseng;

[0015] Furthermore, the ingredients include the following parts by weight: 1 part processed Polygonum multiflorum, 4 parts Ganoderma lucidum, 0.505 parts Morinda officinalis, 4.55 parts Polygonatum sibiricum, and 0.5 parts Panax notoginseng.

[0016] Secondly, the present invention provides an extract for inhibiting prostatic hyperplasia, which is made from the above-mentioned composition.

[0017] Thirdly, the present invention provides a method for preparing an extract that inhibits benign prostatic hyperplasia, wherein the extract is obtained by extraction using the above-mentioned composition as raw material.

[0018] Furthermore, the extraction method includes any one of the following A to C:

[0019] A. Extract each raw material in the composition separately and then mix them to obtain the extract;

[0020] B. Extract one part of the raw materials in the composition separately, and extract the other part of the raw materials after mixing to obtain the extract;

[0021] C. Extract the raw materials in the composition by mixing and then extracting.

[0022] Furthermore, the extraction is performed twice, the weight ratio of raw material to solvent is 1:10, and the extraction time for each extraction is 2 hours.

[0023] Preferably, the extraction process further includes coarsely crushing the raw materials.

[0024] Preferably, the extraction process further includes filtration and concentration drying.

[0025] Fourthly, the present invention provides the use of the above-described composition or the above-described extract, or the extract prepared by the above-described preparation method, in the preparation of products for inhibiting benign prostatic hyperplasia;

[0026] Fifthly, the present invention provides a medicament for inhibiting benign prostatic hyperplasia, wherein the active ingredient of the medicament is the composition described above, the extract described above, or the extract prepared by the preparation method described above.

[0027] Furthermore, the dosage forms of the drug include oral liquid, granules, capsules, pills, powders, suspensions, tablets, or lozenges;

[0028] Preferably, the drug further includes a carrier or excipients;

[0029] Preferably, the excipients include at least one of flavoring agents, thickeners, lubricants, binders, disintegrants, or fillers.

[0030] This invention provides a composition for inhibiting benign prostatic hyperplasia (BPH). It utilizes a combination of processed Polygonum multiflorum, Ganoderma lucidum, Morinda officinalis, and Panax notoginseng to nourish the liver and kidneys, promote blood circulation, and remove blood stasis, working synergistically with Polygonatum sibiricum. Polygonatum sibiricum replenishes qi and nourishes yin, strengthens the spleen, and moistens the lungs, guiding the other herbs in the formula to the affected area, thus enhancing the efficacy of each ingredient. The combined effects of these herbs achieve the functions of invigorating qi and warming the kidneys, promoting blood circulation, removing blood stasis, strengthening the spleen and stomach, and anti-aging. It can effectively inhibit the growth of BPH-1 cells, improve benign prostatic hyperplasia, and significantly enhance the inhibitory effect on BPH. Furthermore, none of the ingredients have any toxic side effects, making it suitable for long-term use. Detailed Implementation

[0031] Unless otherwise defined herein, the scientific and technical terms used in conjunction with this invention shall have the meanings commonly understood by one of ordinary skill in the art. The meaning and scope of terms shall be clear; however, in any case of potential ambiguity, the definitions provided herein shall prevail over any dictionary or foreign definitions. In this application, unless otherwise stated, the use of "or" means "and / or". Furthermore, the use of the term "comprising" and other forms is non-limiting.

[0032] Unless otherwise stated, the methods and techniques of the present invention are generally carried out according to conventional methods well known in the art and as described in various general and more specific references, which are cited and discussed throughout this specification.

[0033] The present invention provides a composition for inhibiting benign prostatic hyperplasia, comprising the following raw materials in parts by weight: 1-4 parts of processed Polygonum multiflorum, 1-4 parts of Ganoderma lucidum, 0.505-2.02 parts of Morinda officinalis, 1.54-4.55 parts of Polygonatum sibiricum, and 0.5-2 parts of Panax notoginseng.

[0034] By utilizing processed Polygonum multiflorum, Ganoderma lucidum, Morinda officinalis, and Panax notoginseng in combination to nourish the liver and kidneys and promote blood circulation, this formula works synergistically with Polygonatum sibiricum. Polygonatum sibiricum replenishes qi and nourishes yin, strengthens the spleen, and moistens the lungs, guiding the other herbs in the formula to the affected area, thus enhancing the efficacy of each ingredient. The combined effects of these herbs achieve the functions of invigorating qi and warming the kidneys, promoting blood circulation, removing blood stasis, strengthening the spleen and stomach, and anti-aging. It can effectively inhibit the growth of BPH-1 cells, improve benign prostatic hyperplasia, and significantly enhance the inhibitory effect on benign prostatic hyperplasia. Furthermore, none of the ingredients have any toxic side effects, making it suitable for long-term use.

[0035] Processed Polygonum multiflorum is slightly warm in nature, sweet and astringent in taste, and enters the liver and kidney meridians. The Compendium of Materia Medica records that Polygonum multiflorum is a nourishing medicine with the effects of tonifying the liver and kidneys, replenishing essence and blood, and blackening hair. Processed Polygonum multiflorum contains anthraquinones, flavonoids, phenylpropanoids, sterols, and other components. Current pharmacological studies show that it has anti-aging effects, neuroprotective effects, enhances immunity, lowers blood lipids, and has anti-atherosclerotic effects.

[0036] Morinda officinalis, pungent, sweet, and slightly warm in nature, enters the kidney meridian. Its functions include tonifying the kidney and strengthening yang, dispelling wind and dampness. The *Shennong Bencao Jing* (Shennong's Classic of Materia Medica) states that it "strengthens tendons and bones, calms the five internal organs, replenishes the middle jiao, enhances willpower, and benefits qi," classifying it as a superior herb and a "key medicine for tonifying kidney yang." Morinda officinalis contains polysaccharides, iridoids, amino acids, anthraquinones, and other components. Current pharmacological studies show that it has antioxidant, anti-aging, and angiogenesis-promoting effects.

[0037] Panax notoginseng, with a sweet and slightly bitter taste and warm nature, enters the liver and stomach meridians. It has the functions of promoting blood circulation and relieving pain, and removing blood stasis. Modern research shows that Panax notoginseng contains various chemical components such as saponins, flavonoids, cyclic peptides, sterols, sugars, and amino acids, and has protective effects on the cardiovascular and nervous systems, as well as anti-inflammatory and antibacterial properties.

[0038] Reishi mushroom is sweet and neutral in nature. It enters the heart, lung, liver, and kidney meridians, and has the effects of calming the mind and replenishing qi. The Compendium of Materia Medica records that it "strengthens the body's resistance and consolidates its foundation; long-term consumption can lighten the body, prevent aging, and prolong life like an immortal." Reishi mushroom contains polysaccharides, triterpenoids, and other components, and modern pharmacological studies have proven that it has antioxidant, anti-aging, and immune-enhancing effects.

[0039] Polygonatum rhizome is sweet and neutral in nature. It enters the heart, lung, liver, and kidney meridians, and has the functions of tonifying qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. The *Mingyi Bielu* states that "Polygonatum rhizome primarily tonifies the middle jiao and benefits qi, eliminates dampness, and soothes the five internal organs. Long-term use lightens the body, prolongs life, and reduces hunger." Polygonatum rhizome contains polysaccharides, saponins, flavonoids, and other components, and modern pharmacological studies have proven its antioxidant, anti-aging, hypoglycemic, and anti-inflammatory effects.

[0040] In this formula, prepared Polygonum multiflorum and Morinda officinalis tonify the kidneys and boost yang, replenish essence and blood; Panax notoginseng invigorates blood and removes blood stasis; Ganoderma lucidum and Polygonatum sibiricum tonify qi, strengthen the spleen, and moisten the lungs. The combined effects of these herbs tonify kidney essence, remove blood stasis and unblock collaterals, strengthen the spleen and moisten the lungs, and promote urination, thus treating both the symptoms and root cause of benign prostatic hyperplasia.

[0041] Symptoms of benign prostatic hyperplasia (BPH) include frequent urination at night, difficulty urinating, urinary stream splitting, urinary hesitancy, and even urinary retention. These clinical manifestations are closely related to kidney deficiency and blood stasis. The *Shengji Zonglu* (Comprehensive Records of Sacred Relief) states, "Insufficient kidney essence, impaired qi transformation, and obstructed qi flow lead to urinary retention due to heat accumulation in the bladder and blocked urinary tract." Wang Qingren of the Qing Dynasty stated in *Yilin Gaicuo* (Corrections of Errors in Medical Classics), "Lumps must be formed from tangible blood." Therefore, BPH is essentially a stagnation of blood stasis. Thus, BPH is rooted in kidney qi deficiency and manifested by blood stasis, a mixed deficiency and excess syndrome. Treatment primarily focuses on promoting blood circulation, removing blood stasis, tonifying qi, and warming the kidneys. This formula, in addition to promoting blood circulation, removing blood stasis, tonifying qi, and warming the kidneys, also incorporates lung-moistening and spleen-strengthening effects. Moistening the lungs allows for normal distribution of body fluids and smooth urination, while strengthening the spleen enables the herbs to reach the affected area, resulting in a better synergistic effect among the ingredients.

[0042] Benign prostatic hyperplasia (BPH) is more common in middle-aged and elderly men, a group characterized by old age and weakness, primarily kidney deficiency and blood stasis. This treatment utilizes a combination of processed Polygonum multiflorum, Ganoderma lucidum, Morinda officinalis, and Panax notoginseng to nourish the liver and kidneys, promote blood circulation, and remove blood stasis, working synergistically with Polygonatum sibiricum. Polygonatum sibiricum replenishes qi and yin, strengthens the spleen, and moistens the lungs, guiding the other herbs in the formula to the affected area, thus enhancing the overall efficacy of each ingredient. The combined effects of these herbs invigorate qi and warm the kidneys, promote blood circulation, remove blood stasis, strengthen the spleen and stomach, and have anti-aging properties. It can effectively inhibit BPH-1 cell growth, improve BPH, and significantly enhance the inhibitory effect on BPH. Furthermore, all ingredients are listed as both food and medicine, with no contraindications or toxic side effects, making it suitable for long-term use.

[0043] Specifically, the prepared Polygonum multiflorum can be in portions of, but not limited to, 1, 2, 3, or 4, or any number of portions between 1 and 4.

[0044] The amount of Ganoderma lucidum can be, but is not limited to, 1, 2, 3 or 4 parts, or any number between 1 and 4 parts.

[0045] Morinda officinalis can be used in quantities of, but not limited to, 0.505, 0.6, 0.8, 1.0, 1.2, 1.4, 1.6, 1.8, 2.0, or 2.02 parts, or any number of parts between 0.505 and 2.02.

[0046] The amount of Polygonatum can be, but is not limited to, 1.54 parts, 1.8 parts, 2.0 parts, 2.2 parts, 2.5 parts, 2.7 parts, 3.0 parts, 3.2 parts, 3.5 parts, 3.7 parts, 4.0 parts, 4.2 parts, 4.4 parts, or 4.55 parts, or any number of parts between 1.54 and 4.55.

[0047] Panax notoginseng can be used in quantities of, but not limited to, 0.5, 0.8, 1.0, 1.2, 1.4, 1.6, 1.8, or 2.0 parts, or any number of parts between 0.5 and 2.

[0048] To further enhance the inhibitory effect of the composition on benign prostatic hyperplasia, the dosage of each raw material was optimized.

[0049] In some specific embodiments, the raw materials include the following parts by weight: 1-2 parts of processed Polygonum multiflorum, 3.35-4 parts of Ganoderma lucidum, 0.505-1.01 parts of Morinda officinalis, 3.2-4.55 parts of Polygonatum sibiricum, and 0.5-1 parts of Panax notoginseng;

[0050] In some specific embodiments, the raw materials include the following parts by weight: 1 part of processed Polygonum multiflorum, 4 parts of Ganoderma lucidum, 0.505 parts of Morinda officinalis, 4.55 parts of Polygonatum sibiricum, and 0.5 parts of Panax notoginseng.

[0051] By optimizing the dosage of each raw material, the inhibitory effect of the composition on benign prostatic hyperplasia can be improved.

[0052] In another aspect, the present invention provides an extract for inhibiting prostatic hyperplasia, which is made from the above-described composition.

[0053] Extracts prepared from the various active pharmaceutical ingredients in the composition allow the efficacy of the active pharmaceutical ingredients to be released, further enhancing the inhibitory effect on benign prostatic hyperplasia.

[0054] In another aspect, the present invention provides a method for preparing an extract that inhibits benign prostatic hyperplasia, wherein the above-mentioned composition is used as a raw material to extract the extract.

[0055] The extraction process can refer to existing technologies, specifically water extraction or alcohol extraction, with water extraction being preferred.

[0056] In order to avoid differences in the extraction effects of each raw material and thus affect the efficacy of the extract, in practice, it is possible to extract each raw material separately or to extract the extract after mixing the raw materials.

[0057] In some specific implementations, the extraction method includes any one of the following A to C:

[0058] A. Extract each raw material in the composition separately and then mix them to obtain the extract;

[0059] B. Extract one part of the raw materials in the composition separately, and extract the other part of the raw materials after mixing to obtain the extract;

[0060] C. Extract the raw materials in the composition by mixing and then extracting.

[0061] The extraction was performed twice, with a raw material to solvent weight ratio of 1:10, and each extraction lasted for 2 hours.

[0062] Preferably, the extraction process further includes coarsely crushing the raw materials.

[0063] The particle size of each raw material after coarse grinding is 0.5–20 mm.

[0064] In some specific implementations, the extraction process further includes filtration and concentration / drying. Maltodextrin may be added to the concentrate before drying.

[0065] Adding maltodextrin to the concentrate can ensure uniform dispersion of the extract; the drying process includes baking, freeze-drying, or spray drying, with spray drying being preferred. The concentration method is not limited; vacuum concentration or thermal evaporation concentration can be selected, and the specific concentration method and the concentration of the concentrate can be chosen based on the drying method.

[0066] In another aspect, the present invention provides the use of the above-described composition or extract, or the extract prepared by the above-described preparation method, in the preparation of products for inhibiting benign prostatic hyperplasia.

[0067] In another aspect, the present invention provides a medicament for inhibiting benign prostatic hyperplasia, wherein the active ingredient of the medicament is the above-described composition or the above-described extract, or an extract prepared by the above-described preparation method.

[0068] In some specific embodiments, the dosage form of the drug includes oral liquid, granules, capsules, pills, powders, suspensions, and tablets;

[0069] Preferably, the drug also includes a carrier or excipients;

[0070] Preferably, the excipients include at least one of flavoring agents, thickeners, lubricants, binders, disintegrants, or fillers.

[0071] The drug can also be a conventional formulation, a sustained-release formulation, a controlled-release formulation, or various microparticle delivery systems. To formulate unit-dose dosage forms into tablets, a wide variety of carriers and excipients known in the art can be widely used, such as diluents and absorbents like starch, dextrin, calcium sulfate, lactose, mannitol, sucrose, sodium chloride, glucose, urea, calcium carbonate, kaolin, microcrystalline cellulose, aluminum silicate, etc.; humectants and binders like water, glycerin, polyethylene glycol, ethanol, propanol, starch paste, dextrin, syrup, honey, glucose solution, gum arabic paste, gelatin paste, sodium carboxymethyl cellulose, shellac, methyl cellulose, potassium phosphate, etc. Polyvinylpyrrolidone, etc.; disintegrants, such as dried starch, alginate, agar powder, brown algae starch, sodium bicarbonate and citric acid, calcium carbonate, polyoxyethylene, sorbitol fatty acid esters, sodium lauryl sulfonate, methylcellulose, ethylcellulose, etc.; disintegration inhibitors, such as sucrose, tristearate, cocoa butter, hydrogenated oil, etc.; absorption promoters, such as quaternary ammonium salts, sodium lauryl sulfate, etc.; lubricants, such as talc, silica, corn starch, stearates, boric acid, liquid paraffin, polyethylene glycol, etc. Tablets can also be further formulated into coated tablets, such as sugar-coated tablets, film-coated tablets, enteric-coated tablets, or bilayer and multilayer tablets. To formulate unit-dose dosage forms into pills, a wide variety of carriers known in the art can be used, such as diluents and absorbents like glucose, lactose, starch, cocoa butter, hydrogenated vegetable oil, polyvinylpyrrolidone, kaolin, talc, etc.; binders like gum arabic, tragacanth, gelatin, ethanol, honey, liquid sugar, rice paste, or flour paste, etc.; and disintegrants like agar powder, dried starch, alginate, sodium dodecyl sulfate, methylcellulose, ethylcellulose, etc. Furthermore, colorants, preservatives, flavorings, tasters, or other materials can be added to the pharmaceutical preparation if necessary.

[0072] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Unless otherwise specified, the materials in the embodiments are prepared according to existing methods or purchased directly from the market.

[0073] The processed Polygonum multiflorum extract used in Examples 1-3 below was purchased from Guangdong Qingyunshan Pharmaceutical Co., Ltd., batch number 20230301; Ganoderma lucidum extract was purchased from Guangdong Qingyunshan Pharmaceutical Co., Ltd., batch number 20221102; Morinda officinalis extract was purchased from Guangdong Yifang Pharmaceutical Co., Ltd., batch number S2305022; Polygonatum sibiricum extract was purchased from Guangdong Qingyunshan Pharmaceutical Co., Ltd., batch number 20221002; Panax notoginseng extract was purchased from Guangdong Qingyunshan Pharmaceutical Co., Ltd., batch number 20221101; and erythritol was purchased from Shandong Sanyuan Biotechnology Co., Ltd., batch number 20220903.

[0074] Example 1

[0075] A composition for inhibiting benign prostatic hyperplasia comprises the following raw materials in parts by weight: 2 parts of processed Polygonum multiflorum extract (equivalent to 2 parts of medicinal material), 3.35 parts of Ganoderma lucidum extract (equivalent to 3.35 parts of medicinal material), 1.01 parts of Morinda officinalis extract (equivalent to 1 part of medicinal material), 3.2 parts of Polygonatum sibiricum extract (equivalent to 3.2 parts of medicinal material), and 1 part of Panax notoginseng extract, and then 6 parts of erythritol are added, and the mixture is stirred evenly to obtain the product.

[0076] Example 2

[0077] A composition for inhibiting benign prostatic hyperplasia comprises the following raw materials in parts by weight: 1 part of processed Polygonum multiflorum extract (equivalent to 1 part of medicinal material), 4 parts of Ganoderma lucidum extract (equivalent to 4 parts of medicinal material), 0.505 parts of Morinda officinalis extract (equivalent to 0.505 parts of medicinal material), 4.55 parts of Polygonatum sibiricum extract (equivalent to 0.5 parts of medicinal material), and then 6 parts of erythritol are added. After mixing evenly, the product is obtained.

[0078] Example 3

[0079] A composition for inhibiting benign prostatic hyperplasia comprises the following raw materials in parts by weight: 4 parts of processed Polygonum multiflorum extract (equivalent to 4 parts of medicinal material), 1 part of Ganoderma lucidum extract (equivalent to 1 part of medicinal material), 2.02 parts of Morinda officinalis extract (equivalent to 2 parts of medicinal material), 1.54 parts of Polygonatum sibiricum extract (equivalent to 1.54 parts of medicinal material), and 2 parts of Panax notoginseng extract (equivalent to 2 parts of medicinal material), and then 6 parts of erythritol are added, and the mixture is stirred evenly to obtain the product.

[0080] Example 4

[0081] A composition for inhibiting benign prostatic hyperplasia is prepared by means of the following components in parts by weight: 2 parts of processed Polygonum multiflorum, 3.35 parts of Ganoderma lucidum, 1.01 parts of Morinda officinalis, 3.2 parts of Polygonatum sibiricum, and 1 part of Panax notoginseng. The raw materials are coarsely pulverized and mixed. Water is added at a ratio of 1:10, and the mixture is decocted for 2 hours and filtered. The resulting residue is then decocted twice more with a ratio of 1:8 water for 2 hours each time, followed by filtration. The two filtrates are combined and concentrated. 2 parts of maltodextrin are added to the concentrate, and the mixture is dried. Finally, a certain amount of erythritol is added to bring the total to 6 parts, and the mixture is thoroughly mixed to obtain the final product.

[0082] Example 5

[0083] A composition for inhibiting benign prostatic hyperplasia is prepared by means of the following components in parts by weight: 1 part processed Polygonum multiflorum, 4 parts Ganoderma lucidum, 0.505 parts Morinda officinalis, 4.55 parts Polygonatum sibiricum, and 0.5 parts Panax notoginseng. The raw materials are coarsely pulverized and mixed. Water is added at a ratio of 1:10, and the mixture is decocted for 2 hours and filtered. The resulting residue is then decocted twice more with a ratio of 1:8 water for 2 hours each time, followed by filtration. The two filtrates are combined and concentrated. 2 parts maltodextrin are added to the concentrate, and the mixture is dried. Finally, erythritol is added to a final volume of 6 parts, and the mixture is thoroughly mixed to obtain the final product.

[0084] Example 6

[0085] A composition for inhibiting benign prostatic hyperplasia is prepared by means of the following components in parts by weight: 4 parts of processed Polygonum multiflorum, 1 part of Ganoderma lucidum, 2.02 parts of Morinda officinalis, 1.54 parts of Polygonatum sibiricum, and 2 parts of Panax notoginseng. The raw materials are coarsely pulverized and mixed. Water is added at a ratio of 1:10, and the mixture is decocted for 2 hours and filtered. The resulting residue is then decocted twice more with a ratio of 1:8 water for 2 hours each time, followed by filtration. The two filtrates are combined and concentrated. 2 parts of maltodextrin are added to the concentrate, and the mixture is dried. Finally, erythritol is added to a final volume of 6 parts, and the mixture is thoroughly mixed to obtain the final product.

[0086] Comparative Example 1

[0087] The only difference between this comparative example and Example 1 is that the raw materials of the composition contain only Polygonatum extract, which is equivalent to 3.2 parts of medicinal material. The insufficient part is made up to 6 parts with erythritol.

[0088] Comparative Example 2

[0089] The only difference between this comparative example and Example 1 is that the raw materials of the composition do not contain Polygonatum extract, and the insufficient part is made up to 6 parts with erythritol.

[0090] Comparative Example 3

[0091] The only difference between this comparative example and Example 2 is that the raw materials of the composition contain only Polygonatum extract, which is equivalent to 4.55 parts of medicinal material. The insufficient part is made up to 6 parts with erythritol.

[0092] Comparative Example 4

[0093] The only difference between this comparative example and Example 2 is that the raw materials of the composition do not contain Polygonatum extract, and the insufficient part is made up to 6 parts with erythritol.

[0094] Comparative Example 5

[0095] The only difference between this comparative example and Example 3 is that the raw materials of the composition contain only Polygonatum extract, which is equivalent to 1.54 parts of medicinal material. The insufficient part is made up to 6 parts with erythritol.

[0096] Comparative Example 6

[0097] The only difference between this comparative example and Example 3 is that the raw materials of the composition do not contain Polygonatum extract; otherwise, they are the same as in Example 3.

[0098] Comparative Example 7

[0099] This comparative example uses a traditional Chinese medicine composition for treating benign prostatic hyperplasia disclosed in Chinese patent document CN111375022A as a raw material to prepare the extract. All raw materials consist of American ginseng extract (Guangdong Qingyunshan Pharmaceutical Co., Ltd., batch number 20230501), Astragalus extract (Guangdong Qingyunshan Pharmaceutical Co., Ltd., batch number 20220101), Lycium barbarum extract (Qinghai Kangpu Biotechnology Co., Ltd., batch number KPGQZTQW-E-23-01), Polygonatum sibiricum extract (same as above), Panax notoginseng extract (same as above), and Glycyrrhiza uralensis extract (Guangdong Yifang Pharmaceutical Co., Ltd., batch number AL2212922), and are mixed evenly. The amount of raw material extracts, converted to the weight of the medicinal materials, is: American ginseng 7.5 parts; Astragalus membranaceus 5 parts; Lycium barbarum 10 parts; Polygonatum sibiricum 10 parts; Panax notoginseng 1.5 parts; and Glycyrrhiza uralensis 1 part.

[0100] Inhibition test of different compositions on BPH-1 cells

[0101] This experiment used extracts prepared in Examples 1-3 and Comparative Examples 1-7 to verify their inhibitory effect on human benign prostatic hyperplasia (BPH-1) cells, while also including a blank control group and a control group. The specific experimental steps are as follows:

[0102] Cell culture: Human benign prostatic hyperplasia (BPH-1) cells were cultured in RPMI 1640 medium containing 20% ​​fetal bovine serum, 20 ng / mL testosterone, 5 μg / mL transferrin, 5 ng / mL sodium selenite, 5 μg / mL insulin, and 1% anti-inflammatory agent, and passaged in a 37°C, 5% CO2 incubator. 100 IU / L penicillin and 100 μg / mL streptomycin were added to the culture medium.

[0103] Experimental testing: Well-grown BPH-1 cells in the logarithmic growth phase were digested with 0.25% trypsin and seeded into 96-well plates, with 7000 cells per well. 100 μl of culture medium was added to each well, and the plates were incubated at 37°C in a 5% CO2 incubator. After 24 hours, the culture medium was discarded, and the experiments were conducted.

[0104] In the control group, 100 μL of prepared complete culture medium was added; in the blank group, no cells were added, and it served as a zeroing well; the extracts of Examples 1-3 and Comparative Examples 1-7 were diluted with complete culture medium to an extract concentration of 6.25 mg / mL and incubated at 37°C in a 5% CO2 incubator. After 24 h, the culture medium was discarded, 10 μL of MTT diluent was added to each well, and the plate was incubated for 4 h. Then, the MTT was discarded, 150 μL of LDMSO was added to each well to dissolve the crystals, and the plate was gently shaken for 10 min. After the purple crystals were fully dissolved, the absorbance value A at 570 nm was measured using an enzyme-linked spectrophotometer to reflect the number of viable cells.

[0105] BPH-1 cell viability (%) = (A value of experimental group - A value of blank group) ÷ (A value of control group - A value of blank group) × 100%;

[0106] BPH-1 cell inhibition rate (%) = 100% - BPH-1 cell survival rate.

[0107] The specific experimental results are shown in Table 1.

[0108] Table 1. Results of the inhibitory effects of different compositions on BPH-1 cells.

[0109]

[0110]

[0111] Wherein, *** represents an extremely significant difference compared to the control group (p<0.001); &&& represents an extremely significant difference between the examples and the control group containing only Polygonatum extract at the same concentration (p<0.001); # represents a significant difference between the examples and the control group containing no Polygonatum extract at the same concentration (p<0.05); and ### represents p<0.001. The representative example showed a significant difference compared to Comparative Example 7, p<0.01.

[0112] Table 1 shows that the BPH-1 cell survival rate in Examples 1-3 was significantly lower than that in the control group, indicating that Examples 1-3 have a strong inhibitory effect on benign prostatic hyperplasia (BPH). Comparative Examples 2, 4, and 6 also showed significantly lower BPH-1 cell survival rates compared to the control group, indicating that processed Polygonum multiflorum, Ganoderma lucidum, Morinda officinalis, and Panax notoginseng, at certain doses, can improve BPH. However, Comparative Examples 1, 3, and 5 showed no significant difference compared to the control group, indicating that the composition containing only Polygonatum sibiricum does not have an inhibitory effect on BPH.

[0113] Compared with Comparative Examples 1 and 2, Example 1 showed a significantly lower percentage of BPH-1 cell survival, indicating that the composition (processed Polygonum multiflorum, Ganoderma lucidum, Morinda officinalis, Polygonatum sibiricum, Panax notoginseng) was more effective than Comparative Example 2 (processed Polygonum multiflorum, Ganoderma lucidum, Morinda officinalis, Panax notoginseng) under the same dosage conditions. Comparative Example 1 (Polygonatum sibiricum) showed that there was a synergistic effect among the raw materials in the composition. Polygonatum sibiricum itself does not have an inhibitory effect on prostate hyperplasia, but adding Polygonatum sibiricum to the composition can enhance the inhibitory effect on prostate hyperplasia.

[0114] Similarly, compared to Comparative Examples 3 and 4, Example 2 showed a significantly lower percentage of BPH-1 cell survival; compared to Comparative Examples 5 and 6, Example 3 showed a significantly lower percentage of BPH-1 cell survival, further demonstrating that there is a synergistic effect among the ingredients in this formulation, and that Polygonatum sibiricum can enhance the effect of inhibiting prostate hyperplasia.

[0115] Comparative Example 7 showed a highly significant decrease in BPH-1 cell survival rate compared to the control group, indicating that Comparative Example 7 has an inhibitory effect on benign prostatic hyperplasia (BPH), which is consistent with the research results of patent CN111375022A. Example 2 showed a BPH-1 cell survival rate of only 10.51%, while Comparative Example 7 showed a BPH-1 cell survival rate of 17.11%. Example 2 showed a highly significant decrease in BPH-1 cell survival rate compared to Comparative Example 7 (the preferred embodiment in patent CN111375022A). Examples 1 and 3 showed no significant difference compared to Comparative Example 7, indicating that the embodiments of this scheme have a good or equivalent inhibitory effect on BPH.

[0116] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A composition for inhibiting benign prostatic hyperplasia, characterized in that, It is composed of the following raw materials in parts by weight: 1-4 parts of processed Polygonum multiflorum, 1-4 parts of Ganoderma lucidum, 0.505-2.02 parts of Morinda officinalis, 1.54-4.55 parts of Polygonatum sibiricum, and 0.5-2 parts of Panax notoginseng.

2. The composition according to claim 1, characterized in that, It is composed of the following raw materials in parts by weight: 1-2 parts of processed Polygonum multiflorum, 3.35-4 parts of Ganoderma lucidum, 0.505-1.01 parts of Morinda officinalis, 3.2-4.55 parts of Polygonatum sibiricum, and 0.5-1 parts of Panax notoginseng.

3. The composition according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: 1 part processed Polygonum multiflorum, 4 parts Ganoderma lucidum, 0.505 parts Morinda officinalis, 4.55 parts Polygonatum sibiricum and 0.5 parts Panax notoginseng.

4. An extract for inhibiting benign prostatic hyperplasia, characterized in that, Made from the composition according to any one of claims 1 to 3.

5. A method for preparing an extract that inhibits benign prostatic hyperplasia, characterized in that, The extract is obtained by extraction using the composition according to any one of claims 1 to 3 as a raw material.

6. The preparation method according to claim 5, characterized in that, The extraction method includes any one of the following A~C: A. Extract each raw material in the composition separately and then mix them to obtain the extract; B. Extract one part of the raw materials in the composition separately, and extract the other part of the raw materials after mixing to obtain the extract; C. Extract the raw materials in the composition by mixing and then extracting.

7. The preparation method according to claim 5, characterized in that, The extraction was performed twice, with a raw material to solvent weight ratio of 1:10, and each extraction lasted for 2 hours.

8. The preparation method according to claim 5, characterized in that, The extraction process also includes coarsely crushing the raw materials.

9. The preparation method according to claim 5, characterized in that, The extraction process also includes filtration, concentration, and drying.

10. The use of the composition according to any one of claims 1 to 3, the extract according to claim 4, or the extract prepared by the preparation method according to any one of claims 5 to 9 in the preparation of a medicament for inhibiting benign prostatic hyperplasia.

11. A drug for inhibiting benign prostatic hyperplasia, characterized in that, The active ingredient of the drug is the composition according to any one of claims 1 to 3, the extract according to claim 4, or the extract prepared by the preparation method according to any one of claims 5 to 9.

12. The medicament according to claim 11, characterized in that, The dosage forms of the drug include oral liquid, granules, capsules, pills, powders, suspensions, or tablets.

13. The medicament according to claim 11, characterized in that, The drug may also include a carrier or excipients.

14. The medicament according to claim 13, characterized in that, The excipients include at least one of flavoring agents, thickeners, lubricants, binders, disintegrants, or fillers.

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