Composition for preventing and treating prostatic hyperplasia with medicinal herbs classified as a food ingredient and Manufacturing method thereof

Abstract

The present invention relates to a composition for the prevention and treatment of benign prostatic hyperplasia using herbal medicines classified as food ingredients, and a method for manufacturing the same. More specifically, the herbal medicines used as food ingredients according to the composition of the present invention consist of herbal medicines containing Cuscuta japonica, Cornus officinalis, Dioscorea opposita, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, ginger, Glycyrrhiza glabra, Astragalus membranaceus, Paeonia lactiflora, and Jujube as active ingredients. Furthermore, the specific composition of the present invention is characterized by including, among the herbal medicinal materials, 4-12% by weight of Cuscuta japonica, 4-12% by weight of Cornus officinalis, 4-12% by weight of Dioscorea opposita, 6-18% by weight of Rehmannia glutinosa, 4-12% by weight of Poria cocos, 4-12% by weight of Platycodon grandiflorus, 2-6% by weight of Cnidium officinale, 2-6% by weight of Angelica sinensis, 3-9% by weight of Carthamus tinctorius, 4-12% by weight of Atractylodes macrocephala, 3-9% by weight of Astragalus membranaceus, 4-12% by weight of Paeonia lactiflora, 1-3% by weight of ginger, 3-9% by weight of Glycyrrhiza glabra, and 2-6% by weight of Jujube as active ingredients, and additionally using herbal medicinal materials classified as food ingredients containing, or extracts of said herbal medicinal materials, mixed by further adding 0.36% by weight of Vitamin B6, 0.0006% by weight of Vitamin B7, 0.012% by weight of Vitamin B12, 1.2% by weight of Vitamin C, and 0.072% by weight of zinc. This relates to a composition for the prevention and treatment of benign prostatic hyperplasia. The present invention aims to provide a composition for the prevention and treatment of benign prostatic hyperplasia and a method for manufacturing the same, which improves lower urinary tract symptoms by using components of herbal medicines classified as raw materials usable in food, specifically Cuscuta japonica, Cornus officinalis, Dioscorea opposita, and Rehmannia glutinosa, to restore the body's ability to produce T, to reduce edema of the prostate and surrounding tissues using Poria cocos, to eliminate congestion of the prostate and testicular veins using Angelica sinensis and Cnidium officinale, and to reduce inflammation using Platycodon grandiflorus.

Description

Technology Field

[0001] The present invention relates to a composition for the prevention and treatment of benign prostatic hyperplasia using herbal medicines classified as food ingredients, and a method for manufacturing the same. More specifically, the present invention relates to a composition for the prevention and treatment of benign prostatic hyperplasia that includes herbal medicines classified as food ingredients as active ingredients to suppress the occurrence of side effects, and through synergistic interactions among the active ingredients of 12 types of herbal medicines classified as food ingredients. Among the herbal medicine components according to the present invention, i) the body's T (testosterone) production capacity is restored using Cuscuta japonica, Cornus officinalis, Dioscorea opposita, Rehmannia glutinosa, etc.; ii) edema of the prostate and surrounding tissues is reduced using Poria cocos, etc.; iii) congestion of the prostate and testicular veins is eliminated using Angelica sinensis, Cnidium officinale, and Paeonia lactiflora, etc.; and iv) inflammation is reduced using Platycodon grandiflorus and Paeonia lactiflora, etc., thereby improving lower urinary tract symptoms and providing prevention and treatment of benign prostatic hyperplasia. Background Technology

[0002] As a key technical component forming the background of the present invention, the prostate, an important male accessory sexual organ, is located deep within the pelvic cavity and has a unique capsule structure, which prevents drugs from penetrating easily, making treatment difficult. The prostate is an accessory sexual organ found only in men that produces about one-third of the liquid components of semen; it plays a role in supplying nutrients to sperm produced by the testes to stimulate sperm movement and enhance sperm fertility. Furthermore, a wide variety of diseases, such as prostatitis, benign prostatic hyperplasia, and prostate cancer, occur in the prostate; among these, prostatitis is a highly frequent genitourinary disease, with more than half of adult men experiencing it at least once in their lifetime.

[0003] Generally, patients with prostatitis account for about 15–25% of outpatients, and benign prostatic hyperplasia is one of the diseases commonly seen in people over 60. In particular, benign prostatic hyperplasia is a disease that occurs when the prostate gland enlarges and blocks the urinary tract below the bladder, thereby reducing the flow of urine. Currently, benign prostatic hyperplasia is defined as "complaints of lower urinary tract symptoms in men over 50 years of age, collectively referring to symptoms of bladder emptying disorder such as frequent urination (more than 8 times / day), nocturia, urgency (strong and sudden urge to urinate), urgency (difficulty holding urine), delayed urination (delayed urination), interrupted urination (interruption of urine flow), and the need to strain during urination."

[0004] The most major contributing factors to the development of the aforementioned benign prostatic hyperplasia are increased age and male hormones. Histological enlargement of the prostate begins at age 35, and it is observed in 60% of men in their 60s and 90% of men in their 80s, with 50% of these patients complaining of urinary dysfunction due to the enlargement of the prostate.

[0005] A more important fact is that the exact causes of prostatitis, benign prostatic hyperplasia (BPH), and prostate cancer are still unknown, the symptoms are highly diverse, and treatment methods have not yet been established. Recently, although the precise cause of prostatic hyperplasia (BPH) is unclear, it is presumed to occur primarily due to hormonal influences, while also being affected by metabolic syndrome and aging.

[0006] Furthermore, according to prior art literature (non-patent documents), the primary cause of benign prostatic hyperplasia (BPH) is known to be an increase in DHT (dihydrotestosterone), which is induced by a deficiency in the body's T-production capacity. It is reported that DHT alleviates symptoms of androgen deficiency because its binding ability to androgen receptors is more than 10 times stronger than that of TP. However, as DHT binds strongly to androgen receptors in the prostate and delays their release, substances such as peptide growth factors are secreted in large quantities; these substances then stimulate DNA transcription factors, causing prostate cells to proliferate. .

[0007] Conventional drug treatments for benign prostatic hyperplasia (BPH) are broadly classified into alpha-blockers and androgen inhibitors (5-alpha-reductase inhibitors). Among these, alpha-blockers are drugs that reduce pressure and tension in the prostatic urethra; commercially available alpha-blockers include terazosin, doxazosin, tamsulosin, and alfuzosin. Additionally, 5-alpha-reductase inhibitors II (finasteride and dutasteride), which are representative conventional treatments, inhibit 5-alpha-reductase, an enzyme that converts T to DHT. It has been reported that reducing DHT production suppresses prostatic proliferation and improves lower urinary tract symptoms. . However, the aforementioned 5-alpha reductase inhibitors have the disadvantage of causing androgen deficiency symptoms, which lead to decreased libido and sexual function, muscle weakness, and weak effects in reducing lower urinary tract symptoms, and can worsen non-alcoholic fatty liver disease, insulin-resistant type 2 diabetes, dry eye syndrome, kidney damage, and other metabolic syndromes. .

[0008] On the other hand, restoring blood T12 levels reduces substitution with DHT, resolving benign prostatic hyperplasia or androgenic alopecia caused by increased DHT, and also resolves symptoms of androgen deficiency through the increase in T12. Methods to raise blood T12 levels include introducing T12 into the body from external sources and restoring the body's production capacity. External T12 administration methods include oral medications and injections. Injectables, which are manufactured to be absorbed in small amounts over a long period, are inconvenient, while oral medications are unsuitable as a treatment due to the large fluctuations in blood T12 levels. When T12 is taken orally, levels remain significantly higher than physiological for a certain period and drop below normal levels over time. These methods are unsuitable as treatments because they have the disadvantage that when levels are high, T12 is substituted for estrogen, potentially leading to feminization, while when levels are low, it is substituted for DHT, eventually causing prostate proliferation.

[0009] Another cause of benign prostatic hyperplasia is associated with poor and stagnant venous blood circulation in the testes. When blood stagnates in the testicular veins, venous circulation in the prostate also stagnates, causing the T concentration in the prostate to increase by more than 100 times. It has been reported that excessively high concentrations of T act as a cause of benign prostatic hyperplasia. .

[0010] As mentioned above, selective adrenergic α1-blockers (SAABs) are often used to alleviate lower urinary tract symptoms, which are a source of distress for benign prostatic hyperplasia; however, SAABs have the disadvantage of not being able to inhibit prostate proliferation. ARIs (5-alpha-reductase inhibitors) also improve lower urinary tract symptoms, but they have the disadvantage of being less effective than SAABs. The worsening or improvement of benign prostatic hyperplasia can be identified by changes in IPSS. .

[0011] However, the aforementioned alpha-blockers are merely temporary treatments as they do not reduce the enlargement of the prostate, and side effects such as dizziness, lethargy, headache, and visual impairment have been reported. Additionally, the aforementioned androgen inhibitors are drugs that prevent prostate enlargement by inhibiting 5-alpha-reductase, which plays a key role in the process of prostate enlargement. Finasteride and dutasteride are commercially available as 5-alpha-reductase inhibitors. However, these drugs take a long time to show effects after administration, and side effects related to sexual function have been reported. As such, most drugs currently on the market or under development exhibit various side effects, so there is a need to develop a treatment for benign prostatic hyperplasia with a new mechanism that is easy to consume as food and has almost no side effects associated with conventional drugs.

[0013] As mentioned above, various drugs have been researched and developed for the treatment of prostate diseases; however, the conventional treatment of prostate diseases using traditional Korean medicine has faced the problems described below. Specifically, there is a problem in that drug absorption is not easy due to the location of the prostate and its unique capsule structure. Furthermore, there is a problem in that the drugs developed so far have a limited scope of application, making it impossible to demonstrate various effects and efficacies.

[0015] Accordingly, the inventors have developed a composition for the prevention and treatment of benign prostatic hyperplasia using herbal ingredients classified as food raw materials. This composition resolves the aforementioned problems regarding drug side effects and ensures that there are no side effects such as sexual dysfunction, dizziness, lethargy, headaches, or visual impairment even with long-term use. By utilizing herbal ingredients classified as food while enhancing the body's own immunity, the treatment effect can be enhanced without causing adverse effects on the body even with prolonged use. Furthermore, while conventional antibiotic prostate treatments manufactured with chemical structures often result in side effects such as a reduction in efficacy due to increased drug resistance when used as a long-term treatment, the inventors have completed a composition for the prevention and treatment of benign prostatic hyperplasia using herbal ingredients classified as food raw materials. This composition improves upon these issues and, by utilizing the immunity-boosting properties characteristic of conventional herbal medicines, also exhibits the secondary effect of enhancing virility. Prior art literature

[0016] Publication No. 특2001-0076810 (August 16, 2001),

[0017] - (Deslypere J.P., Young M., Wilson J.D., McPhaul M.J. Testosterone and 5 alpha-dihydrotestosterone interact differently with the androgen receptor to enhance transcription of the MMTV-CAT reporter gene.Mol Cell Endocrinol.1992;88 :15-22.[PubMed ][Google Scholar]).- (Bartsch, G; Rittmaster, RS; Klocker, H (2002). "Dihydrotestosterone and the concept of 5alpha-reductase inhibition in human benign prostatic hyperplasia".World J Urol .19(6): 413-25.doi :10.1007 / s00345-002-0248-5 .PMID 12022710.[Google Scholar]).- (Gat, Y; Gornish, M; Heiblum, M; Joshua, S (2008). "Reversal of benign prostate hyperplasia by selective occlusion of impaired venous drainage in the male reproductive system: novel mechanism, new treatment".Andrologia40(5):273-281.doi:10.1111 / j.1439-0272. 2008.00883.x.PMID 18811916.[Google Scholar]).- (Emberton M., Andriole G.L., de la Rosette J., Djavan B., Hoefner K., Vela Navarrete R. Benign prostatic hyperplasia: a progressive disease of aging men. Urology.2003;61 :267-273.[PubMed][Google Scholar]). The problem to be solved

[0018] The present invention relates to a composition for the prevention and treatment of benign prostatic hyperplasia using medicinal herbs classified as food ingredients, comprising Cuscuta japonica, Cornus officinalis, Dioscorea japonica, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, Astragalus membranaceus, and Paeonia lactiflora, which are classified as food ingredients, and additionally, ginger, licorice, and jujube are mixed as active ingredients with the above 12 types of major medicinal herb components, and a method for manufacturing the same. To explain this more specifically, among the herbal medicine components classified as food ingredients of the present invention, the present invention aims to provide a composition for the prevention and treatment of benign prostatic hyperplasia and a method for manufacturing the same, which improves lower urinary tract symptoms by i) restoring the body's T (testosterone) production capacity with ingredients such as Cuscuta japonica, Cornus officinalis, Dioscorea opposita, and Rehmannia glutinosa, ii) reducing edema of the prostate and surrounding tissues with ingredients such as Poria cocos, iii) eliminating congestion of the prostate and testicular veins with ingredients such as Angelica sinensis, Cnidium officinale, and Paeonia lactiflora, and iv) reducing inflammation with ingredients such as Platycodon grandiflorus and Paeonia lactiflora.

[0020] Accordingly, the purpose of the present invention is to provide a composition for the prevention and treatment of benign prostatic hyperplasia using herbal ingredients (15 ingredients) that include Cuscuta japonica, Dioscorea opposita, Cornus officinalis, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, ginger, Glycyrrhiza glabra, Astragalus membranaceus, Paeonia lactiflora, and Jujube as active ingredients.

[0022] In addition, as an embodiment of the present invention, the composition of the herbal medicine classified as a food ingredient comprises 4-12% by weight of Cuscuta seed, 4-12% by weight of Cornus fruit, 4-12% by weight of Dioscorea japonica, 6-18% by weight of Rehmannia glutinosa, 4-12% by weight of Poria cocos, 4-12% by weight of Platycodon grandiflorus, 2-6% by weight of Cnidium officinale, 2-6% by weight of Angelica sinensis, 3-9% by weight of Carthamus tinctorius, 4-12% by weight of Atractylodes macrocephala, 3-9% by weight of Astragalus membranaceus, 4-12% by weight of Paeonia lactiflora, 1-3% by weight of ginger, 3-9% by weight of Glycyrrhiza glabra, and 2-6% by weight of Jujube as active ingredients, and the purpose is to provide a composition for the prevention and treatment of benign prostatic hyperplasia using herbal medicine.

[0023] According to one embodiment of the present invention, among the components classified as food ingredients, i) a composition for the prevention and treatment of benign prostatic hyperplasia using herbal medicines that restore the body's ability to produce T (testosterone), such as Cuscuta japonica, Cornus officinalis, Dioscorea opposita, and Rehmannia glutinosa, as active ingredients, and ii) additionally, among the components of herbal medicines classified as food ingredients of the present invention, a composition for the prevention and treatment of benign prostatic hyperplasia that improves lower urinary tract symptoms by reducing swelling of the prostate and surrounding tissues with Poria cocos, etc., eliminating congestion of the prostate and testicular veins with Angelica sinensis and Cnidium officinale, etc., and reducing inflammation with Platycodon grandiflorus, etc., thereby providing a method for manufacturing the same.

[0024] Accordingly, the present invention is composed of Cuscuta chinensis, Cornus officinalis, Dioscorea japonica, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, Astragalus membranaceus, and Paeonia lactiflora, which are classified as food ingredients according to the composition of the present invention. Additionally, the purpose is to provide a composition for the prevention and treatment of benign prostatic hyperplasia that is composed of three additional herbal ingredients, ginger, licorice, and jujube, mixed as active ingredients with the above 12 types of major herbal ingredients.

[0026] In addition, another composition of the present invention enhances the effect of inhibiting prostate proliferation and improving lower urinary tract symptoms by adding vitamins B6, B7, B12, and C to 15 types of food-grade herbal ingredients containing the herbal ingredients or extracts thereof as active ingredients. Furthermore, the purpose is to provide a composition for the prevention and treatment of benign prostatic hyperplasia prepared by adding zinc (Zn) after adding vitamins B6, B7, B12, and C to 15 types of food-grade herbal ingredients.

[0027] To explain this in more detail, regarding the total weight of the above herbal medicines in the 15 types of food ingredients, The purpose is to provide a composition for the prevention and treatment of benign prostatic hyperplasia in another formulation using a herbal medicine classified as a food ingredient, characterized by including as active ingredients an herbal medicine or an extract of said herbal medicine, which is further mixed by adding 0.36% by weight (30mg / 1pc) of vitamin B6, 0.0006% by weight (0.05mg / 1pc) of B7, 0.012% by weight (1.0mg / pc) of B12, 1.2% by weight (100mg / pc) of vitamin C, and 0.072% by weight (6mg / pc) of zinc in a compositional ratio.

[0028] In addition, another aspect of the present invention is to provide a composition for the prevention and treatment of benign prostatic hyperplasia using a medicinal herb classified as a food ingredient, characterized in that the composition prepared using the medicinal herb or an extract of the medicinal herb as an active ingredient is in the form of a pill, granule, powder, capsule, tablet, liquid, or topical agent.

[0029] In addition, the product composition can be formed by adding necessary substances, such as golden extract, date palm extract, fermented hibiscus extract, honey or sugar, or excipients, to the present composition. means of solving the problem

[0030] To achieve the above-mentioned objectives of the present invention, which utilizes herbal ingredients classified as food ingredients to restore the body's testosterone production capacity and improve blood circulation in the testicular veins, thereby inhibiting the progression of benign prostatic hyperplasia unlike conventional treatments, and to alleviate lower urinary tract symptoms by eliminating edema and congestion in the prostate and surrounding tissues, and the method for manufacturing the same, the main herbal ingredients classified as food ingredients according to the composition of the present invention are used as a composition for the prevention and treatment of benign prostatic hyperplasia using herbal ingredients that restore the body's T (testosterone) production capacity, among the compositions classified as food ingredients according to one embodiment of the present invention, i) with active ingredients such as Cuscuta japonica, Cornus officinalis, Dioscorea opposita, and Rehmannia glutinosa, used as active ingredients; and ii) additionally, among the components of the herbal ingredients classified as food ingredients of the present invention, to reduce edema in the prostate and surrounding tissues using Poria cocos, etc., to eliminate congestion in the prostate and testicular veins using Angelica sinensis and Cnidium officinale, and to reduce inflammation using Platycodon grandiflorus, etc. The present invention aims to provide a composition for improving lower urinary tract symptoms and for the prevention and treatment of benign prostatic hyperplasia, as well as a method for manufacturing the same.

[0031] Accordingly, the composition is composed of 15 types of food ingredients classified as food ingredients according to the composition of the present invention, including Cuscuta seed, Cornus fruit, Dioscorea japonica, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, Astragalus membranaceus, and Paeonia lactiflora. Additionally, the composition is characterized by using 15 types of food ingredients, including ginger, licorice, and jujube, which are mixed as active ingredients with the above 12 types of major herbal ingredients.

[0032] Furthermore, another configuration of the present invention enhances the effect of inhibiting prostate proliferation and improving lower urinary tract symptoms by adding vitamins B6, B7, B12, and C to 15 types of food-grade herbal ingredients containing the above herbal ingredients or their extracts as active ingredients. Moreover, it relates to a composition for the prevention and treatment of benign prostatic hyperplasia prepared by adding zinc (Zn) after adding vitamins B6, B7, B12, and vitamin C to 15 types of food-grade herbal ingredients. To explain this more specifically, regarding the total weight of the above herbal ingredients in the 15 types of food-grade herbal ingredients It is characterized by being used as another formulation of a composition for the prevention and treatment of benign prostatic hyperplasia using a herbal medicine classified as a food ingredient, which is characterized by including, as an active ingredient, a herbal medicine or an extract of said herbal medicine, which is further mixed by adding 0.36% by weight (30mg / 1pc) of vitamin B6, 0.0006% by weight (0.05mg / 1pc) of B7, 0.012% by weight (1.0mg / pc) of B12, 1.2% by weight (100mg / pc) of vitamin C, and 0.072% by weight (6mg / pc) of zinc in a compositional ratio.

[0033] In addition, to achieve the above-mentioned purpose of the present invention, the main herbal medicinal ingredients classified as food ingredients according to the composition of the present invention are characterized by containing, as active ingredients, 4-12% by weight of Cuscuta seed, 4-12% by weight of Cornus fruit, 4-12% by weight of Dioscorea japonica, 6-18% by weight of Rehmannia glutinosa, 4-12% by weight of Poria cocos, 4-12% by weight of Platycodon grandiflorus, 2-6% by weight of Cnidium officinale, 2-6% by weight of Angelica sinensis, 3-9% by weight of Carthamus tinctorius, 4-12% by weight of Atractylodes macrocephala, 3-9% by weight of Astragalus membranaceus, 4-12% by weight of Paeonia lactiflora, 1-3% by weight of ginger, 3-9% by weight of Glycyrrhiza glabra, and 2-6% by weight of Jujube.

[0034] In addition, to achieve the above-mentioned purpose of the present invention, the main herbal medicine used as a food ingredient according to the composition of the present invention is characterized by including, as an active ingredient, an herbal medicine or an extract of said herbal medicine, which is mixed by adding 0.36% by weight of vitamin B6, 0.0006% by weight of B7, 0.012% by weight of B12, 1.2% by weight of C, and 0.072% by weight of zinc to the herbal medicine classified as a food ingredient.

[0035] A composition prepared using the herbal medicine or an extract of the herbal medicine according to the composition of the present invention as an active ingredient is characterized in that it is a pill, granule, powder, capsule, tablet, liquid, or topical agent.

[0037] Furthermore, in order to achieve the above-mentioned objective of the present invention, a method for preparing a composition for the prevention and treatment of benign prostatic hyperplasia using herbal medicines classified as food ingredients comprises the steps of: preparing 10 kg of a mixture of herbal medicines, wherein the herbal medicines classified as food ingredients include 4-12% by weight of Cuscuta japonica, 4-12% by weight of Cornus officinalis, 4-12% by weight of Dioscorea opposita, 6-18% by weight of Rehmannia glutinosa, 4-12% by weight of Poria cocos, 4-12% by weight of Platycodon grandiflorus, 2-6% by weight of Cnidium officinale, 2-6% by weight of Angelica gigas, 3-9% by weight of Carthamus tinctorius, 4-12% by weight of Atractylodes macrocephala, 3-9% by weight of Astragalus membranaceus, 4-12% by weight of Paeonia lactiflora, 1-3% by weight of ginger, 3-9% by weight of Glycyrrhiza glabra, and 2-6% by weight of Jujube, as active ingredients; and adding 20 L of purified water to the 10 kg of the herbal medicine mixture and steeping for 2-3 hours. The method is characterized by comprising the steps of: adding 20L of purified water to the herbal medicine mixture that has been soaked; and preparing the herbal medicine mixture with the added purified water by placing it in a vacuum low-temperature extractor and extracting it with hot water for 12 hours; and further comprising the step of preparing the herbal medicine extract prepared by placing the herbal medicine mixture with the added purified water into a vacuum low-temperature extractor and extracting it with hot water for 12 hours, by placing the extract into a vacuum low-temperature concentrator and concentrating its volume to 1 / 10 to extract it into a concentrated liquid of 2.5L.

[0038] In addition, to achieve the above-mentioned purpose of the present invention, a beverage composition for the prevention and treatment of benign prostatic hyperplasia according to one embodiment of the present invention is characterized by containing 40 to 60% by weight of the herbal medicine or an extract of the herbal medicine relative to the total weight of the beverage composition. Effects of the invention

[0040] The present invention comprises ingredients classified as food ingredients, including Cuscuta seed, Cornus fruit, Dioscorea japonica, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, Astragalus membranaceus, and Paeonia lactiflora. Additionally, by mixing ginger, licorice, and jujube as active ingredients with the above 12 types of major herbal ingredients, the invention has the effect of minimizing the occurrence of side effects. That is, in order to exhibit heterogeneous effects according to the composition of the present invention, the composition for the prevention and treatment of benign prostatic hyperplasia, which is the composition of the present invention, is prepared by first adding ginger, licorice, and jujube as active ingredients to the above 12 major herbal ingredients classified as food ingredients, including Cuscuta seed, Cornus fruit, Dioscorea japonica, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, Astragalus membranaceus, and Paeonia lactiflora as active ingredients, to the above 12 major herbal ingredients, and further mixing them to have a complex synergistic effect between the ingredients.

[0041] To explain the effects of these ingredients in detail, first, i) they restore the body's ability to produce T (testosterone) using ingredients such as Cuscuta seed, Cornus fruit, Dioscorea japonica, and Rehmannia glutinosa; ii) they reduce swelling of the prostate and surrounding tissues using ingredients such as Poria cocos; iii) they eliminate congestion in the prostate and testicular veins using ingredients such as Angelica sinensis, Ligusticum chuanxiong, and Paeonia lactiflora; iv) they reduce inflammation using ingredients such as Platycodon grandiflorus and Paeonia lactiflora to improve lower urinary tract symptoms; and v) by mixing Safflower with Angelica sinensis and Ligusticum chuanxiong, the efficacy of eliminating congestion in the prostate and testicular veins and increasing circulation is enhanced through the thrombolytic (blood stasis) removal effect. And, vi) in addition to the main herbal ingredients of Cuscuta seed, Cornus fruit, Dioscorea japonica, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, Astragalus membranaceus, and Paeonia lactiflora, three additional herbal ingredients, ginger, licorice, and jujube, are added to the above 12 main herbal ingredients to create a complex synergistic effect among the herbal ingredients, which ultimately increases the recovery of activity of T-producing cells and reduces the action of 5-reductase, thereby having a complex effect that can resolve benign prostatic hyperplasia overall. Brief explanation of the drawing

[0042] FIG. 1 is a flowchart showing the manufacturing process of a composition for the prevention and treatment of benign prostatic hyperplasia containing a medicinal herb classified as a food ingredient of the present invention, and FIG. 2 is a diagram showing the experimental results of the liquid tea composition (Example 3) and control groups using the composition for the prevention and treatment of benign prostatic hyperplasia extracted in a concentrated liquid form according to the present invention. FIG. 3 is a diagram showing the change in the average concentration of T of a user of the liquid tea 1 composition (Example 3) using a composition for the prevention and treatment of benign prostatic hyperplasia extracted in a concentrated liquid form containing a herbal medicine classified as a food ingredient of the present invention. Figure 4 is a diagram showing a comparison of changes in the International Prostate Symptom Score (IPSS) of a user of the liquid tea composition (Example 3) using a concentrated liquid extract containing a herbal medicine classified as a food ingredient of the present invention for the prevention and treatment of benign prostatic hyperplasia, a user of the control group ARI, and a user of SAI. Specific details for implementing the invention

[0043] The configuration of the present invention will be specifically explained below through Figure 1 and embodiments of the present invention.

[0044] One embodiment of the present invention relates to a composition for the prevention and treatment of benign prostatic hyperplasia using herbal medicines classified as food ingredients, and a method for manufacturing the same. More specifically, the present invention relates to a composition for the prevention and treatment of benign prostatic hyperplasia that includes herbal medicines classified as food ingredients as active ingredients to suppress the occurrence of side effects and utilizes the synergistic effect of the active ingredients of herbal medicines classified as food ingredients. Among the herbal ingredients of the present invention, the body's ability to produce T is restored using Cuscuta japonica, Cornus officinalis, Dioscorea opposita, and Rehmannia glutinosa; edema of the prostate and surrounding tissues is reduced using Poria cocos; congestion of the prostate and testicular veins is eliminated using Angelica sinensis and Cnidium officinale; and inflammation is reduced using Platycodon grandiflorus to improve lower urinary tract symptoms and prevent and treat benign prostatic hyperplasia.

[0045] To achieve the above-mentioned purpose, the present invention comprises 15 types of medicinal herbs used as food ingredients according to the composition of the present invention, including Cuscuta seed, Cornus fruit, Dioscorea japonica, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, ginger, Glycyrrhiza glabra, Astragalus membranaceus, Paeonia lactiflora, and Jujube as active ingredients.

[0047] (1) Dodder (scientific name; Cuscuta chinensis Lamark ) is the seed of the dodder, which belongs to the Convolvulaceae family. It is a medicinal herb that helps boost yang energy and strengthens the genitourinary system, and is effective for male impotence, spontaneous ejaculation, and nocturnal emissions.

[0048] (2) Cornus officinalis (scientific name; Corni fructusIt is made by steaming and drying the pulp of Cornus fruit with the seeds removed, and is effective for frequent urination, erectile dysfunction, and premature ejaculation. It also treats symptoms such as menstruation not stopping in women, premature ejaculation in men, and inability to hold urine.

[0049] (3) Chinese yam (scientific name; Dioscoreae rhizoma ) ; It is a dried, sliced ​​root of the yam from which impurities have been removed, and it has been confirmed that yam treats nocturnal emissions (premature ejaculation), leukorrhea, and frequent urination.

[0050] (4) Rehmannia glutinosa (scientific name; Rehmanniae radix preparat ) is made by removing impurities from the root of raw Rehmannia glutinosa, steaming it nine times with yellow wine, and drying it. It is effective in treating nocturnal emissions, leukorrhea, degenerative arthritis caused by osteoporosis, and gray hair.

[0051] (5) Poria cocos is a mushroom of the family Polyporaceae, order Polyporales, class Basidiomycetes (scientific name: Poria cocos It is obtained by removing the outer layer of the sclerotium (root nodule) of the plant, slicing it to a thickness of 1-2 mm, and drying it in the shade. It is effective in eliminating edema in the digestive system and brain, thereby improving symptoms of bloating and heaviness in the head. It promotes water flow and removes moisture. In the modern pharmacological sense, it eliminates tissue edema through diuretic action, and in this invention, it is used for the purpose of eliminating edema around the prostate.

[0052] (6) Platycodon (scientific name; Platycodi radix ) is made by harvesting balloon flower roots in spring and autumn and drying them in the sun, and it eliminates inflammation of the prostate with its pus-draining and expectorant effects that reduce inflammation and phlegm.

[0053] (7) Cnidium (scientific name; Cnidii rhizoma ) is the dried root of Cnidium officinale, a perennial herbaceous plant belonging to the Apiaceae family, and is mainly effective in eliminating blood stasis and improving blood circulation.

[0054] (8) Angelica (scientific name; Angelicae gigantis radix In Korea, the dried root of the Korean angelica plant is used as a medicinal herb, and angelica eliminates blood stasis and improves blood circulation.

[0055] (9) Safflower (scientific name; Carthami flos Safflower refers to the dried flowers of the safflower, a plant belonging to the Asteraceae family, with the stamens removed. The flowers are picked in early summer when the yellow blossoms turn red and dried in the shade. It has a pungent taste and a warm nature. It acts on the Liver and Heart meridians. It promotes blood circulation, eliminates blood stasis, regulates menstruation, and induces abortion. In small amounts, it nourishes the blood.

[0056] (10) Atractylodes (scientific name; Atractyloidis macrocephalae rhizoma The roots of Atractylodes are harvested between the first frost and the beginning of winter and dried in the sun to be used as a medicinal herb. With the efficacy of tonifying the spleen and benefiting the stomach, pharmacologically it is confirmed to strengthen the digestive system and aid in digestive movement.

[0057] (11) Ginger (scientific name: Zingiber officinale Ginger refers to the root of a perennial plant of the Zingiberaceae family, Zingiber order, of monocotyledonous plants. Mature ginger roots are peeled and sliced ​​to a thickness of 2-5 mm for use. It is reported to assist all medications and eliminate phlegm to relieve dizziness or nausea; as a medicinal herb, it harmonizes medications and prevents them from becoming harsh due to its harmonizing properties.

[0058] (12) Licorice (scientific name: Glycyrrhiza uralensis Licorice refers to the root of a perennial herb belonging to the Fabaceae family of the Rosales order of dicotyledonous plants. Licorice root refers to licorice root that has had its hairs removed, sliced ​​into 1 cm wide strips, and dried in the sun. The effects of licorice root include detoxifying and harmonizing all medicinal substances. Its detoxifying action and harmonizing properties soften the strong medicinal nature of drugs.

[0059] Jujubes, ginger, and licorice are commonly used to neutralize the strong properties of the medicine and reduce the burden on the stomach.

[0060] (13) Astragalus (scientific name; Astragali radix Astragalus root is used as a medicinal herb, and Astragalus primarily eliminates inflammation of the prostate and induces apoptosis (programmed cell death) in aged prostate cells through its efficacy of detoxifying and regenerating tissue.

[0061] (14) Red peony (scientific name: Paeoniae radix rubra) It is made by harvesting the roots of the red peony, a perennial herb belonging to the Ranunculaceae family, removing the skin and fine hairs, steaming them, slicing them into 1cm thick pieces, and drying them in the sun, and it is effective in eliminating blood stasis and inflammation.

[0062] (15) Jujube (scientific name; Jujubae fructus The fruit of ) is used as a medicinal ingredient, and jujube strengthens the digestive system and harmonizes and softens all medicines.

[0063] The above-described major herbal medicines are used to exemplify a method of manufacturing, and the composition for the prevention and treatment of benign prostatic hyperplasia using herbal medicines classified as food ingredients and the method of manufacturing the same are as follows.

[0065] Example 1. Method for preparing a composition (liquid) for the prevention and treatment of benign prostatic hyperplasia

[0066] (1) Step 1 of selecting herbal ingredients for food (S10);

[0067] Fifteen types of medicinal herbs classified as food ingredients of the present invention are selected and prepared by quantifying them (processing the herbs to increase their medicinal properties). Specifically, this is composed of Cuscuta seed, Cornus fruit, Dioscorea japonica, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, Astragalus membranaceus, and Paeonia lactiflora. Additionally, the composition is characterized by mixing three types of additional medicinal herbs—ginger, licorice, and jujube—as active ingredients with the above 12 main medicinal herb components. However, among the above medicinal herbs, the remaining herbs, excluding licorice, are primarily of Korean origin, and may be substituted with herbs from other countries depending on market conditions. Each selected medicinal herb is quantified separately according to the quantification method appropriate for the herb.

[0068] (2) Step 2 of preparation of the composition ratio of herbal medicines containing active ingredients (S20);

[0069] The measured drugs are prepared according to the composition ratio of the present invention, that is, the composition ratio of the 15 types of herbal ingredients used as food raw materials is specifically selected to make 10 kg of herbal ingredients containing 4-12% by weight of Cuscuta seed, 4-12% of Cornus fruit, 4-12% of Dioscorea japonica, 6-18% of Rehmannia glutinosa, 4-12% of Poria cocos, 4-12% of Platycodon grandiflorus, 2-6% of Cnidium officinale, 2-6% of Angelica sinensis, 3-9% of Carthamus tinctorius, 4-12% by weight of Atractylodes macrocephala, 3-9% by weight of Astragalus membranaceus, 4-12% by weight of Paeonia lactiflora, 1-3% by weight of ginger, 3-9% by weight of Glycyrrhiza glabra, and 2-6% by weight of Jujube as active ingredients.

[0070] (3) Step 3 (S30) of mixing and inoculating the above 15 types of herbal medicines;

[0071] Select the above 15 types of herbal medicines, prepare 10 kg, add 20 L of purified water to them, and steep for 2-3 hours.

[0072] (4) Low-pressure low-temperature extraction 4 steps (S40);

[0073] After additionally mixing 20L of purified water into the above-mentioned mixture of 15 types of herbal medicines, the mixture of herbal medicines mixed with purified water is placed in a vacuum low-temperature extractor and hot water extracted for 12 hours to first prepare a composition for the prevention and treatment of benign prostatic hyperplasia in liquid form.

[0074] (5) Step 5 (S50) Preparation of a composition for the prevention and treatment of benign prostatic hyperplasia in the form of an extracted concentrated liquid;

[0075] Among all processes from step 1 to step 4 above, the liquid substance extracted in step 3 of Example 1 described above is placed in a vacuum low-temperature concentrator and concentrated to a volume of approximately 1 / 10, thereby preparing a composition for the prevention and treatment of benign prostatic hyperplasia extracted as a concentrated liquid of 2.5L.

[0077] Example 2. Method for preparing a composition (liquid) for the prevention and treatment of benign prostatic hyperplasia containing vitamins and zinc

[0078] Vitamin B6 0.36% by weight (30mg / 1pc), B7 0.0006% by weight (0.05mg / 1pc), B12 0.012% by weight (1.0mg / pc), C 1.2% by weight (100mg / pc) and zinc 0.072% by weight (6mg / pc) can be further added to the liquid substance of the third step of the above-described Example 1, based on the total weight of the 15 types of food raw herbal medicines of the second step of Example 1. Then, among all processes from the first to the fourth step, the liquid substance extracted in the third step of the above-described Example 1 is placed in a vacuum low-temperature concentrator and concentrated to reduce the volume to approximately 1 / 10, thereby preparing a composition for the prevention and treatment of benign prostatic hyperplasia extracted as a concentrated liquid of 2.5L.

[0080] Example 3. Method for preparing liquid tea 1 using a composition for the prevention and treatment of benign prostatic hyperplasia extracted as a concentrated liquid (S61)

[0081] The method for preparing a liquid tea using the extracted liquid composition for the prevention and treatment of benign prostatic hyperplasia according to the present invention involves adding natural water sterilized by heat treatment, and optionally Scutellaria root extract, Jujube palm extract, fermented hibiscus extract, honey, and sugar to the liquid substance extracted in step 3 of Examples 1 and 2 described above, and packaging it into 1,200 packs with a volume of 30-100 mL depending on the use. In this experiment, the liquid tea was prepared using a known 50 mL liquid packaging tea (in the form of a stick or pouch).

[0083] Example 4. Method for preparing liquid tea 2 using a composition for the prevention and treatment of benign prostatic hyperplasia extracted as a concentrated liquid.

[0084] Liquid tea is prepared by adding rectified water to 2.25 mL of the concentrated liquid composition for the prevention and treatment of benign prostatic hyperplasia, which is prepared by the manufacturing method of Examples 1 and 2 described above. Additionally, additives such as liquid fructose may be added, and the packaging unit may be adjusted.

[0086] Example 5. Method for preparing freeze-dried powder of a composition for the prevention and treatment of benign prostatic hyperplasia extracted in a concentrated liquid form (S62)

[0087] A composition for the prevention and treatment of benign prostatic hyperplasia, extracted as a concentrated liquid by the manufacturing method of Examples 1 and 2 described above, is freeze-dried by adding an excipient. It is then finely ground and packaged in 3g or 6g portions. While adding the excipient, natural water sterilized by heat treatment and, if necessary, goldenrod extract, date palm extract, fermented hibiscus extract, honey, and sugar may be added to the concentrated liquid material in advance according to the intended use.

[0089] Example 6. Method for preparing a jelly using a composition for the prevention and treatment of benign prostatic hyperplasia extracted as a concentrated liquid.

[0090] A composition for the prevention and treatment of benign prostatic hyperplasia, extracted as a concentrated liquid by the manufacturing method of Examples 1 and 2 described above, is mixed with additives such as xanthan gum and agar to form a jelly, and packaged in the required amount. While adding the additives, natural water sterilized by heat treatment and, if necessary, golden extract, date palm extract, fermented hibiscus extract, honey, and sugar may be added to the concentrated liquid material in advance according to the intended use.

[0092] Example 7. Method for preparing a pill containing a composition for the prevention and treatment of benign prostatic hyperplasia

[0093] Step 1; Prepare each herbal medicine according to the composition ratios of Examples 1 and 2 above, and prepare 20 kg by quantification.

[0094] Step 2; Grind the above-prepared 20 kg of herbal medicine to make 10 kg of fine powdered herbal medicine mixture.

[0095] Step 3; 10 kg of fine powdered herbal medicine mixture is prepared by making a hot water extraction solution using steps 2 and 3 of Examples 1 and 2 above, and then concentrated to make 7 L of concentrated liquid material.

[0096] Step 4; mix 3 L of honey with 7 L of a concentrated liquid extract of a composition for the prevention and treatment of benign prostatic hyperplasia, boil for 10 minutes, and then filter out the residue to make a mixed solution.

[0097] Step 5; Mix the remaining 10 kg of fine powder herbal medicine mixture from Step 2 with the mixed solution prepared in Step 4 and glutinous rice porridge, and let it mature for 12 hours.

[0098] Step 6; The herbal medicine mixture prepared through Step 5 above is made into a 5mm pill.

[0100] Example 8. Method for preparing granules

[0101] The herbal medicine mixture obtained from steps 1-5 of Example 7 above is fed into an extruder to be manufactured into granules.

[0103] Example 9. Method for manufacturing a beverage

[0104] After undergoing the process of Example 1 or Example 2 described above, a certain amount of rectified water is added to 2.25 mL of concentrated liquid material of the herbal medicine composition to produce a beverage composition containing 40 to 60 weight percent of a composition for the prevention and treatment of benign prostatic hyperplasia prepared as an active ingredient, based on the total weight of the beverage composition.

[0106] [Test Example 1]

[0107] Animal experiments to study benign prostatic hyperplasia (BPH) present many difficulties. Since experimental animals differ from humans who live upright, BPH similar to that in humans does not naturally occur in them, and it is also difficult to induce it artificially. For this reason, the present invention was developed through comparative research on patients (people) scheduled for treatment who visited the inventor's clinic. A comparative study was conducted on 17 patients treated with the present invention, 6 patients treated with ARI, and 5 patients treated with SAAB at the inventor's clinic (a medical clinic and a Korean medicine clinic, where the inventor is both a doctor and a Korean medicine doctor).

[0109] In the experimental group of the liquid tea composition 1 (Example 3) using the composition for the prevention and treatment of benign prostatic hyperplasia extracted as a concentrated liquid according to the composition of the present invention, 17 subjects were sampled and treated by taking 50 mL each in the morning and evening. Six subjects treated with ARI (finasteride, trade name Proscar 5 mg, one tablet daily) were used as the first control group for the experiment. For the experimental cases, changes in the blood concentration of T and IPSS were measured before administration, at 3 months of administration, and at 6 months of administration. Additionally, IPSS was measured in the same manner for five subjects treated with SAAB (tamsulosin 0.4 mg, one tablet daily) as the second control group. The overall results of the experiment in Test Example 1 are shown in Table 1 below (see Fig. 2).

[0110] Experimental results of the liquid tea composition 1 (Example 3) using the composition for the prevention and treatment of benign prostatic hyperplasia extracted in a concentrated liquid form according to the present invention and the control groups Before taking At the 3-month mark of administration At the 6-month mark of use Change in T concentration (ng / mL) in liquid tea users 4.64(100%) ***S=1.038 5.38(115.9%) S=1.169 5.90(127.2%) S=1.139 Change in T concentration (ng / dL) in ARI users (Control Group 1) 4.73(100%) S=0.558 4.95(104.7%) S=0.450 5.08(107.4%) S=0.546 Change in IPSS score (points) of the user of the present invention 13.8(100%) S=3.17 9.4(-31.0%) S=3.52 7.9(-42.8%) S=3.19 *Change in IPSS of ARI users (Control Group 1) (points) 13.0(100%) S=3.11 11.0(-15.4%) S=2.52 8.5(-34.6%) S=2.57 **Change in IPSS of SAAB users (Control Group 2) (points) 14.8(100%) S=1.47 8.6(-41.9%) S=1.47 7.6(-48.7%) S=1.47

[0111] *ARI; 5-Alpha Reductase InhibitorII

[0112] **SAAB; Selective Alpha-1 Adrenergic Blocker

[0113] ***S; Standard deviation

[0114] Number of participants; Total 28 people,

[0115] Taking the present invention; 17 people,

[0116] Taking 5-alpha reductase inhibitors (ARI); 6 people,

[0117] Selective α1-blocker use (SAAB); 5 people.

[0118] Dosage and method of administration; A liquid tea composition (Example 3) using a composition for the prevention and treatment of benign prostatic hyperplasia extracted as a concentrated liquid was taken twice a day, in the morning and evening.

[0119] [IPSS(International Prostate Syndrome Score)] International Prostate Symptom Score (IPSS) 0 1 2 3 4 5 None at all 1 or fewer out of 5 times 1 out of 2 times or less About half More than half Almost always My score 1. sensation of residual urine 2. Frequent urination 3. Intermittent voiding 4. Sudden urination 5. Weak urine stream 6. Delayed urination 7. Nocturia 0 times 1 time 2nd time 3 times 4th time 5th time IPSS Total Score S = points, 1-7 points mild, 8-19 points moderate, 20-35 points severe

[0120] 1. Sensation of incomplete bladder emptying; How often in the past month have you felt unsatisfied and had urine remaining after urination?

[0121] 2. Frequent urination; How often in the past month have you urinated again within 2 hours of urinating?

[0122] 3. Intermittent urination; How often in the past month has your urine stream been interrupted multiple times each time you urinated?

[0123] 4. Urgency; How often in the past month have you found it difficult to hold your urine when you felt the urge?

[0124] 5. Weak urine stream; How often have you felt that your urine stream was weak in the past month?

[0125] 6. Delayed urination; How often in the past month have you had to strain to urinate because it did not come out immediately?

[0126] 7. Nocturia; How many times did you wake up at night to urinate in the past month?

[0128] 2) Explanation of detailed changes - Changes in aT

[0129] The T concentrations of the user of the present invention and the control group (ARI users) were measured and compared before consumption, at 3 months, and at 6 months of consumption. By confirming the detailed changes in T concentration between the experimental group that consumed the liquid tea composition 1 (Example 3) using the composition for the prevention and treatment of benign prostatic hyperplasia extracted in a concentrated liquid form according to the present invention and the control group (ARI users), the effect of consumption according to the composition of the present invention was confirmed. The effect will be explained in detail through Tables 3 and 4 below, and Figures 3 and 4.

[0130] [ Change in T (Users of the present invention and control group ARI users) ] Change in T Average before taking Average after 3 months of use Average after 6 months of use User of the present invention Average, ng / dL 4.64 5.38 5.90 Percentage, increase / decrease (100%) (115.9%) (+15.9%) (127.2%) (+27.2%) Standard deviation =1.038 S=1.169 S=1.139 ARI users (control group) Average, ng / dL 4.73 4.95 5.08 Percentage, increase / decrease (100%) (104.7%)(+4.7%) (107.4%)(+7.4%) Standard deviation S=0.558 S=0.450 S=0.546

[0131] The average concentration change of T in a user of the liquid tea composition 1 (Example 3), which is a composition for the prevention and treatment of benign prostatic hyperplasia extracted as a concentrated liquid containing a herbal medicine classified as a food ingredient of the present invention, increased from 4.64 ng / dL (100%) with a standard deviation (S) of 1.038 before consumption to 5.38 ng / dL (115.9%) with a standard deviation (S) of 1.169 after 3 months of consumption, and to 5.90 ng / dL (127.2%) with a standard deviation (S) of 1.139 after 6 months of consumption. On the other hand, in the control group that took an ARI inhibiting the substitution of T to DHT, the average T concentration increased slightly from 4.73 ng / dL (100%) S=0.558 before administration to 4.95 ng / dL (104.7%) S=0.45 after 3 months of administration and to 5.08 ng / dL (107.4%) S=0.546 after 6 months of administration. Compared to the control group, the T concentration of the subjects of the present invention increased significantly. This indicates that the body's ability to synthesize T has been restored (see Fig. 3).

[0132] [ Changes in IPSS (Comparison of the user of the present invention with the control group users of ARI and SAI)] Average IPSS before administration Average IPSS at 3 months of administration Average IPSS at 6 months of administration User of the present invention average 13.8 (100%) S=3.17 9.4 (69%)(-31.0%) S=3.52 7.9 (57.2%)(-42.8%) S=3.19 %, +- / Increase / Decrease S = standard deviation ARI users (control group 1) average 13.0 (100%) S=3.11 11.0 (84.6%)(-15.4%) S=2.52 8.5 (65.4%)(-34.6%) S=2.57 %, +- / Increase / Decrease S = standard deviation SAAB users (control group 2) average 14.8 (100%) S=1.47 8.6 (58.1%)(-41.9%) S=1.47 7.6 (51.3%) (-48.7%) S=1.47 %, +- / Increase / Decrease S = standard deviation

[0133] The changes in the International Prostate Symptom Score (IPSS) of 17 users of the liquid tea composition 1 (Example 3), which is a composition for the prevention and treatment of benign prostatic hyperplasia extracted in a concentrated liquid form containing herbal medicines classified as food ingredients according to the composition of the present invention, were compared with the changes in the International Prostate Symptom Score of 6 users of ARI (Control Group 1) and 5 users of SAAB (Control Group 2).

[0134] The effect on benign prostatic hyperplasia can be determined by changes in the International Prostate Symptom Score (IPSS). There were 17 patients taking the invention, and 6 patients taking a 5-alpha-reductase inhibitor (ARI) and 5 patients taking a selective α1-blocker (SAI) were compared as a control group.

[0135] The average change in IPSS of the user of the present invention improved from 13.8 points (standard deviation 3.17) before use to 9.4 points (standard deviation 3.52, -4.4 points, -31.9%) after 3 months of use and 7.9 points (standard deviation 3.19, -5.9 points, -42.8%) after 6 months of use.

[0136] Patients taking ARI showed improvement from 13.0 points (standard deviation 3.11) before administration to 11.0 points (standard deviation 2.52, -2.0 points, 15.4%) after 3 months and 8.5 points (standard deviation 2.57, -4.5 points, -34.6%) after 6 months. The effect appeared more slowly than with the administration of the present invention. Patients taking SAAB showed rapid improvement from 14.8 points (standard deviation 1.47) before administration to 8.6 points (standard deviation 1.47, -6.2 points, -41.9%) after 3 months and 7.6 points (standard deviation 1.47, -7.2 points, -48.6%) after 6 months. Due to the anti-congestive and anti-inflammatory effects and improved blood circulation of the present invention, IPSS symptoms improved, showing an effect that was slightly slower than with SAAB but faster than with ARI.

[0138] Although embodiments of the present invention have been described above, those skilled in the art will understand that the present invention may be implemented in other specific forms without altering the technical spirit or essential features thereof. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive.

Claims

Claim 1 A composition for the prevention and treatment of benign prostatic hyperplasia using medicinal herbs classified as food ingredients, comprising as active ingredients Cuscuta japonica, Cornus officinalis, Dioscorea japonica, Rehmannia glutinosa, Poria cocos, Platycodon grandiflorus, Cnidium officinale, Angelica gigas, Carthamus tinctorius, Atractylodes macrocephala, Astragalus membranaceus, Paeonia lactiflora, ginger, Glycyrrhiza glabra, and Jujube. Claim 2 A composition for the prevention and treatment of benign prostatic hyperplasia using a herbal medicine classified as a food ingredient according to claim 1, wherein the herbal medicine classified as a food ingredient comprises, as active ingredients, 4-12% by weight of Cuscuta japonica, 4-12% by weight of Cornus officinalis, 4-12% by weight of Dioscorea opposita, 6-18% by weight of Rehmannia glutinosa, 4-12% by weight of Poria cocos, 4-12% by weight of Platycodon grandiflorus, 2-6% by weight of Cnidium officinale, 2-6% by weight of Angelica gigas, 3-9% by weight of Carthamus tinctorius, 4-12% by weight of Atractylodes macrocephala, 3-9% by weight of Astragalus membranaceus, 4-12% by weight of Paeonia lactiflora, 1-3% by weight of ginger, 3-9% by weight of Glycyrrhiza glabra, and 2-6% by weight of Jujube. Claim 3 A composition for the prevention and treatment of benign prostatic hyperplasia using a herbal medicine classified as a food ingredient according to claim 2, comprising as an active ingredient an herbal medicine or an extract of said herbal medicine, which is further mixed by adding 0.36% by weight of Vitamin B6, 0.0006% by weight of Vitamin B7, 0.012% by weight of Vitamin B12, 1.2% by weight of Vitamin C, and 0.072% by weight of zinc relative to the total weight of the 15 herbal medicines classified as food ingredients. Claim 4 In claim 2 or 3, the composition for the prevention and treatment of benign prostatic hyperplasia using a herbal medicine classified as a food ingredient is characterized in that the composition prepared as an active ingredient is in the form of a pill, granule, powder, capsule, tablet, liquid, or topical agent. Claim 5 A method for preparing a composition for the prevention and treatment of benign prostatic hyperplasia using herbal medicines classified as food ingredients, comprising the steps of: preparing 10 kg of a mixture of herbal medicines, wherein the herbal medicines classified as food ingredients include 4-12% by weight of Cuscuta japonica, 4-12% by weight of Cornus officinalis, 4-12% by weight of Dioscorea opposita, 6-18% by weight of Rehmannia glutinosa, 4-12% by weight of Poria cocos, 4-12% by weight of Platycodon grandiflorus, 2-6% by weight of Cnidium officinale, 2-6% by weight of Angelica sinensis, 3-9% by weight of Carthamus tinctorius, 4-12% by weight of Atractylodes macrocephala, 3-9% by weight of Astragalus membranaceus, 4-12% by weight of Paeonia lactiflora, 1-3% by weight of ginger, 3-9% by weight of Glycyrrhiza glabra, and 2-6% by weight of Jujube, as active ingredients; and adding 20 L of purified water to the 10 kg of the herbal medicine mixture and steeping for 2-3 hours. A method for preparing a composition for the prevention and treatment of benign prostatic hyperplasia using a herbal medicine classified as a food ingredient, comprising: a step of additionally mixing 20L of purified water into the herbal medicine mixture that has been soaked; and a step of placing the herbal medicine mixture with the additionally mixed purified water into a vacuum low-temperature extractor and extracting it with hot water for 12 hours. Claim 6 A method for preparing a composition for the prevention and treatment of benign prostatic hyperplasia using a herbal medicine classified as a food ingredient, comprising: in claim 5, a step of preparing a medicinal herbal medicine extract by placing the herbal medicine mixture, to which the purified water is additionally mixed, into a vacuum low-temperature extractor and extracting it with hot water for 12 hours, then placing the extract into a vacuum low-temperature concentrator and concentrating it to 1 / 10 of its volume to produce a concentrated liquid of 2.5L. Claim 7 A beverage composition for preventing benign prostatic hyperplasia using a herbal medicine classified as a food ingredient, characterized by containing 40% to 60% by weight of a concentrated liquid of a composition for preventing and treating benign prostatic hyperplasia using a herbal medicine classified as a food ingredient, manufactured by the method of claim 6 above, relative to the total weight of the beverage composition.

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