WO2020106233A1 - Developed herbal composition for use on bph (benign prostate hyperplasia) and/or prostate adenoma - Google Patents

Developed herbal composition for use on bph (benign prostate hyperplasia) and/or prostate adenoma

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Publication number
WO2020106233A1
WO2020106233A1 PCT/TR2018/050757 TR2018050757W WO2020106233A1 WO 2020106233 A1 WO2020106233 A1 WO 2020106233A1 TR 2018050757 W TR2018050757 W TR 2018050757W WO 2020106233 A1 WO2020106233 A1 WO 2020106233A1
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WO
WIPO (PCT)
Prior art keywords
herbal composition
weight
composition according
range
cucurbita pepo
Prior art date
Application number
PCT/TR2018/050757
Other languages
French (fr)
Inventor
Natig YUSUBOV
Original Assignee
Gmg Grand Medical Ilaclari Limited Sirketi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gmg Grand Medical Ilaclari Limited Sirketi filed Critical Gmg Grand Medical Ilaclari Limited Sirketi
Publication of WO2020106233A1 publication Critical patent/WO2020106233A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/77—Sapindaceae (Soapberry family), e.g. lychee or soapberry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

Definitions

  • the invention discloses a pharmaceutical herbal composition containing urtica dioica (nettle), serenoea repens (dwarf palm), aesculus hippocastanum (horse chestnut) and cucurbita pepo (summer squash) for use on people with BPH and/or prostate adenoma in order to comprehensively eliminate chronic urinary retention symptoms.
  • the invention also discloses the method of manufacturing this herbal composition.
  • the prostate is a gland located in the lower urinary tract, below the bladder, situated around the urethra (urinary canal located on the exit of the bladder). It only exists in males, and secretes a fluid that contributes to the semen.
  • a healthy prostate is approximately the size of a large walnut and its volume is 15-25 ml. The prostate grows slowly as men grow older.
  • Prostate diseases usually arise in later ages. It causes disturbing symptoms in the lower urinary tract in men over 50 years of age. These symptoms are more often due to the growth of the prostate, a disease known as benign prostate hyperplasia.
  • Benign prostatic hyperplasia is also known as benign prostate enlargement and is a chronic urination disorder that prevents urinary flow due to an enlarged prostate around the urethra obstructing the bladder exit. Benign prostate enlargement is a common condition. It is associated with hormonal changes that occur in men with age. BPH can affect normal urination and may have a negative impact on quality of life, leading to lower urinary tract symptoms. It is one of the most frequently diagnosed diseases in urology.
  • BPH prostate cancer
  • BPH symptoms reveal a difficulty in urination and painful urination, failure to completely empty the bladder, and a frequent urge to urinate.
  • Symptoms associated with benign prostate enlargement may affect urination in various ways such as the amount of urine in the bladder (storage), urination, and the feeling after urination .
  • Storage symptoms need to urinate more frequently than normal, need to awaken at night to urinate, need for sudden urination and inability to delay this, and incontinence are considered storage symptoms.
  • the most preferred method for BPH patients with moderate symptoms is drug treatment.
  • Alpha blockers, 5-Alpha reductase inhibitors, muscarinic receptor antagonists and phosphodiesterase 5 inhibitors are used.
  • Alpha blockers are a group of drugs that improve the symptoms and urine flow by loosening the smooth muscles of the prostate. It is the most frequently prescribed group of drugs for male BPH patients. Examples of drugs in this group include alfuzosin, doxazosin, tamsulosin, terazosin, silodosin.
  • alfuzosin examples include alfuzosin, doxazosin, tamsulosin, terazosin, silodosin.
  • the problem with the alpha-blocker group of drugs in the prior art is that they fail to reduce prostate size, or to prevent it from growing. Additionally, alpha-blockers can lead to retrograde ejaculation (semen discharge into the bladder).
  • 5 Alpha reductase inhibitors constitute a group that prevents the growth of the prostate, even decreasing its size. These drugs are more effective if the prostate is larger than 40 milliliters and are prescribed when prostate growth causes disturbing symptoms. These drugs can reduce the risk of urinary retention and the need for surgical intervention. However, 5ARI are recommended for treatments that last more than 1 year, since they take a long time to eliminate the symptoms.
  • Muscarinic receptor antagonists constitute a group that reduces the abnormal contractions of the bladder. It can be beneficial against signs of compression caused by BPH in men. But if the bladder cannot be fully emptied and excess urine remains in the bladder after urination, these drugs are usually not prescribed.
  • WO2017164707A1 numbered "pharmaceutical composition and dietary supplement for preventing or treating overactive bladder caused by secondary bladder degeneration due to bladder outlet obstruction caused by benign prostatic hyperplasia"
  • titled patent application discloses a formulation containing Cornus officinalis fruit, angelica gigas, lycium chinense, stag horn, red ginseng and cinnamomum cassia press extracts and a blocker that selectively acts on an alpha-lA- adrenergic receptor.
  • This invention is shown to have an excellent medical effect on overactive bladders caused by secondary bladder degeneration due to bladder output obstruction caused by benign prostatic hyperplasia.
  • Another preparation available on the market, Prostatonin contains urtica dioica and pygenium africanum as active agents . This capsule form that contains a combination of two active substances helps relieve the initial symptoms of benign prostatic hyperplasia.
  • the inventor has developed a new formulation and the method of production thereof in order to overcome all the problems mentioned in the prior art.
  • the object of the invention is to help prevent difficult embolism by reducing the symptoms of painful urination, frequent urination, nocturia, feeling of completely emptying the bladder, and need to urinate in cases of first and second stage prostate adenoma and prostatitis through the formulation that is developed and the product obtained through the method of production.
  • the formulation of the invention comprises composition in specified ratios, reduces the prostate volume, relieves swelling and pain, and stops inflammation. This eliminates urethral muscle spasms. Furthermore, it allows adequate diuresis and prevents prostate adenoma from further growth.
  • a further object of the invention is to avoid swallowing difficulties in geriatric patients, to increase compliance with treatment and to contribute to the patient's medication and continued treatment. Therefore the formulation was developed for liquid forms such as suspensions, syrups, etc.
  • the production method of the invention allows the production of liquid forms.
  • Another object of the invention is to overcome the aforementioned problems of the prior art.
  • the formulation of the present invention uses urtica dioica (nettle), serenoa repens (dwarf palm), aesculus hippocastanum (horse chestnut), cucurbita pepo (squash) as active ingredients.
  • Saw palmetto (dwarf palm), serenoa repens is a plant that contains fatty acids. These fatty acids are capable of blocking the 5-alpha-reductase enzyme, which converts testosterone into dihydrotestosterone (DHT). Its effects on DHT production also led to the use of saw palmetto (LUTS) to treat benign prostatic hyperplasia (BPH) and lower urinary symptoms (LUTS) in men.
  • LUTS saw palmetto
  • Urticae dioica provides anti-inflammatory action, inhibits 5-alpha reductase and aromatase activities and therefore suppresses testosterone-induced increases in prostate volume. In conclusion, urticae dioica is effective in the symptomatic treatment of lower urinary tract disorders (nocturia, polyuria, urinary retention).
  • Aesculus hippocastanum is used in the treatment of BPH and prostatitis due to its anti-inflammatory, diuretic and bactericidal effects.
  • Cucurbita pepo extract is a phytotherapeutic agent obtained from the seeds of the squash plant.
  • the invention is a herbal composition developed to comprehensively eliminate the symptoms of chronic urinary retention in patients with BPH and/or prostate adenoma.
  • This herbal composition uses urtica dioica (nettle), serenoa repens (dwarf palm), aesculus hippocastanum (horse chestnut), cucurbita pepo (squash) as active ingredients.
  • a feature of the invention is that it comprises by weight urtica dioicacin the range of 0.1% to 25%, serenoa repens in the range of 1% -30%, aesculus hippocastanum in the range of 1% -36%, cucurbita pepo in the range of 2% -31%.
  • the invention comprises 5-24% by weight of urtica dioica, 1% -15% of serenoa repens, 1.5% -25% of aesculus hippocastanum, 2% -22% range of cucurbita pepo.
  • Another feature of the invention is that it contains viscosifiers, solubilizings, preservatives, acidity regulating agents and solvents as adjuvants.
  • a feature of the invention is that it comprises from 0.01% to 0.1% by weight of viscosifiers.
  • the known viscosifiers in the art such as HEC, MC, PVA, xanthan gum, etc. may be used.
  • the invention preferably uses 0.08% xanthan gum as viscosifier.
  • a feature of the invention is that the invention contains from 1% to 10% by weight of solubilizing.
  • Propylene glycol, vegetable oils, oleic acid ethyl esters, glycerin, ethanol, mono- and di glycerin palmitates, PEG, etc. solubilizing in the art may be used.
  • the invention uses 4% PEG400.
  • a feature of the invention is that the invention contains from 0.01% to 0.9% by weight of preservatives.
  • Preservatives may be selected from the group including methyl, ethyl, propyl paraben and its salts, sodium benzoate, potassium sorbate.
  • by weight of 0.08% sodium benzoate and 0.06% potassium sorbate are used in the invention.
  • a feature of the invention is that the invention contains from 0.01% to 0.4% by weight of acidity regulators.
  • the invention uses 0.04%wt citric acid as acidity regulator.
  • a feature of the invention is that the invention contains from 30% to 85% by weight of preservatives.
  • the invention uses 72% distilled water by weight as solvent.
  • a feature of the invention is that the invention contains from 0.02% to 2% by weight of sweeteners.
  • Sugar, sodium saccharin, aspartame, sorbitol, xylitol, menthol and flavors in the art can be used as sweeteners.
  • the invention uses 0.3% by weight vanilla and hazelnut flavors.
  • Another feature of the herbal composition in the invention is that it is in suspension, syrup or emulsion dosage forms.
  • the object of the invention The production method of developed herbal composition involves comprises distillation of plants, weighing of auxiliary substances, the mixing steps for dispensing / dispersing the active agents (plants), addition of adjuvants and mixing for homogenization.
  • Another feature of the production method of the invention is that all components are individually weighed under a laminar flow system.
  • the production method of the herbal composition that is developed comprises the following steps:
  • Another feature of the production process of the invention is the addition of distilled plants in sequence. • Serenoa repens

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Abstract

The present invention relates to a pharmaceutical herbal -composition comprising by weight of 0.1% - 25% urtica dioica, by weight of 1% - 30% serenoa repens, by weight of 1%-36% aesculus hippocastanum, by weight of 2% - 31% cucurbita pepo developed in order to comprehensively eliminate chronic urinary retention symptoms in people with BPH and/or prostate adenoma. The invention also discloses the production method of the invention comprises the distillation of plants, weighing of adjuvants, dispersion of active agents (plants), addition of adjuvants, and mixing for homogenization.

Description

DEVELOPED HERBAL COMPOSITION FOR USE ON BPH (BENIGN PROSTATE HYPERPLASIA) AND/OR
PROSTATE ADENOMA
Field of the Invention
The invention discloses a pharmaceutical herbal composition containing urtica dioica (nettle), serenoea repens (dwarf palm), aesculus hippocastanum (horse chestnut) and cucurbita pepo (summer squash) for use on people with BPH and/or prostate adenoma in order to comprehensively eliminate chronic urinary retention symptoms. The invention also discloses the method of manufacturing this herbal composition.
Prior Art
The prostate is a gland located in the lower urinary tract, below the bladder, situated around the urethra (urinary canal located on the exit of the bladder). It only exists in males, and secretes a fluid that contributes to the semen. A healthy prostate is approximately the size of a large walnut and its volume is 15-25 ml. The prostate grows slowly as men grow older.
Prostate diseases usually arise in later ages. It causes disturbing symptoms in the lower urinary tract in men over 50 years of age. These symptoms are more often due to the growth of the prostate, a disease known as benign prostate hyperplasia.
Benign prostatic hyperplasia (BPH) is also known as benign prostate enlargement and is a chronic urination disorder that prevents urinary flow due to an enlarged prostate around the urethra obstructing the bladder exit. Benign prostate enlargement is a common condition. It is associated with hormonal changes that occur in men with age. BPH can affect normal urination and may have a negative impact on quality of life, leading to lower urinary tract symptoms. It is one of the most frequently diagnosed diseases in urology.
Prostate diseases may be very worrying, but it is important to know that BPH is not prostate cancer. BPH does not transform into prostate cancer, even when left untreated. However, benign prostate enlargement and prostate cancer may develop with age and can be observed together.
Examination of BPH symptoms reveal a difficulty in urination and painful urination, failure to completely empty the bladder, and a frequent urge to urinate. Symptoms associated with benign prostate enlargement may affect urination in various ways such as the amount of urine in the bladder (storage), urination, and the feeling after urination . Storage symptoms; need to urinate more frequently than normal, need to awaken at night to urinate, need for sudden urination and inability to delay this, and incontinence are considered storage symptoms.
In the state of the art, the most preferred method for BPH patients with moderate symptoms is drug treatment. Alpha blockers, 5-Alpha reductase inhibitors, muscarinic receptor antagonists and phosphodiesterase 5 inhibitors are used.
Alpha blockers are a group of drugs that improve the symptoms and urine flow by loosening the smooth muscles of the prostate. It is the most frequently prescribed group of drugs for male BPH patients. Examples of drugs in this group include alfuzosin, doxazosin, tamsulosin, terazosin, silodosin. However, the problem with the alpha-blocker group of drugs in the prior art is that they fail to reduce prostate size, or to prevent it from growing. Additionally, alpha-blockers can lead to retrograde ejaculation (semen discharge into the bladder).
5 Alpha reductase inhibitors (5ARI) constitute a group that prevents the growth of the prostate, even decreasing its size. These drugs are more effective if the prostate is larger than 40 milliliters and are prescribed when prostate growth causes disturbing symptoms. These drugs can reduce the risk of urinary retention and the need for surgical intervention. However, 5ARI are recommended for treatments that last more than 1 year, since they take a long time to eliminate the symptoms.
Muscarinic receptor antagonists (MRA) constitute a group that reduces the abnormal contractions of the bladder. It can be beneficial against signs of compression caused by BPH in men. But if the bladder cannot be fully emptied and excess urine remains in the bladder after urination, these drugs are usually not prescribed.
Due to the problems of the aforementioned drugs, there are also drugs that contain herbal compositions rather than these active ingredients.
In the prior art, WO2017164707A1 numbered "pharmaceutical composition and dietary supplement for preventing or treating overactive bladder caused by secondary bladder degeneration due to bladder outlet obstruction caused by benign prostatic hyperplasia" titled patent application discloses a formulation containing Cornus officinalis fruit, angelica gigas, lycium chinense, stag horn, red ginseng and cinnamomum cassia press extracts and a blocker that selectively acts on an alpha-lA- adrenergic receptor. This invention is shown to have an excellent medical effect on overactive bladders caused by secondary bladder degeneration due to bladder output obstruction caused by benign prostatic hyperplasia. Another preparation available on the market, Prostatonin, contains urtica dioica and pygenium africanum as active agents . This capsule form that contains a combination of two active substances helps relieve the initial symptoms of benign prostatic hyperplasia.
However, the fact that benign prostatic hyperplasia occurs in men over 50 years of age leads to another problem: geriatric patients have difficulty in swallowing solid oral dosage forms such as capsules, tablets, etc.
The inventor has developed a new formulation and the method of production thereof in order to overcome all the problems mentioned in the prior art.
Description of the Invention
The object of the invention is to help prevent difficult embolism by reducing the symptoms of painful urination, frequent urination, nocturia, feeling of completely emptying the bladder, and need to urinate in cases of first and second stage prostate adenoma and prostatitis through the formulation that is developed and the product obtained through the method of production.
The formulation of the invention comprises composition in specified ratios, reduces the prostate volume, relieves swelling and pain, and stops inflammation. This eliminates urethral muscle spasms. Furthermore, it allows adequate diuresis and prevents prostate adenoma from further growth.
A further object of the invention is to avoid swallowing difficulties in geriatric patients, to increase compliance with treatment and to contribute to the patient's medication and continued treatment. Therefore the formulation was developed for liquid forms such as suspensions, syrups, etc. The production method of the invention allows the production of liquid forms. Another object of the invention is to overcome the aforementioned problems of the prior art.
The formulation of the present invention uses urtica dioica (nettle), serenoa repens (dwarf palm), aesculus hippocastanum (horse chestnut), cucurbita pepo (squash) as active ingredients.
Saw palmetto (dwarf palm), serenoa repens is a plant that contains fatty acids. These fatty acids are capable of blocking the 5-alpha-reductase enzyme, which converts testosterone into dihydrotestosterone (DHT). Its effects on DHT production also led to the use of saw palmetto (LUTS) to treat benign prostatic hyperplasia (BPH) and lower urinary symptoms (LUTS) in men.
Urticae dioica provides anti-inflammatory action, inhibits 5-alpha reductase and aromatase activities and therefore suppresses testosterone-induced increases in prostate volume. In conclusion, urticae dioica is effective in the symptomatic treatment of lower urinary tract disorders (nocturia, polyuria, urinary retention).
Aesculus hippocastanum is used in the treatment of BPH and prostatitis due to its anti-inflammatory, diuretic and bactericidal effects.
Cucurbita pepo extract is a phytotherapeutic agent obtained from the seeds of the squash plant. An experimental study on cucurbita pepo induced prostatic growth through the administration of testosteron and prazosin, and compared three groups (placebo, cucurbita pepo, and cucurbita pepo & Phytosterol-F). In this study, it was found that prostatic protein synthesis was significantly inhibited in both Cucurbita pepo-treated and combination-treated rats compared to the placebo group and prostatic ventral lobe growth was found to be decreased in both groups. (Tsai YS, Tong YC, Cheng JT, Lee CH, Yang FS, Lee HY.Pumpkin seed oil and phytosterol-F can block testosterone/prazosin-induced prostate growth in rats. Urol Int. 2006;77(3):269-74.)
Detailed Description of the Invention
The invention is a herbal composition developed to comprehensively eliminate the symptoms of chronic urinary retention in patients with BPH and/or prostate adenoma. This herbal composition uses urtica dioica (nettle), serenoa repens (dwarf palm), aesculus hippocastanum (horse chestnut), cucurbita pepo (squash) as active ingredients.
A feature of the invention is that it comprises by weight urtica dioicacin the range of 0.1% to 25%, serenoa repens in the range of 1% -30%, aesculus hippocastanum in the range of 1% -36%, cucurbita pepo in the range of 2% -31%. Preferably, the invention comprises 5-24% by weight of urtica dioica, 1% -15% of serenoa repens, 1.5% -25% of aesculus hippocastanum, 2% -22% range of cucurbita pepo.
Another feature of the invention is that it contains viscosifiers, solubilizings, preservatives, acidity regulating agents and solvents as adjuvants.
A feature of the invention is that it comprises from 0.01% to 0.1% by weight of viscosifiers. The known viscosifiers in the art such as HEC, MC, PVA, xanthan gum, etc. may be used. The invention preferably uses 0.08% xanthan gum as viscosifier.
A feature of the invention is that the invention contains from 1% to 10% by weight of solubilizing. Propylene glycol, vegetable oils, oleic acid ethyl esters, glycerin, ethanol, mono- and di glycerin palmitates, PEG, etc. solubilizing in the art may be used. Preferably, the invention uses 4% PEG400. A feature of the invention is that the invention contains from 0.01% to 0.9% by weight of preservatives. Preservatives may be selected from the group including methyl, ethyl, propyl paraben and its salts, sodium benzoate, potassium sorbate. Preferably, by weight of 0.08% sodium benzoate and 0.06% potassium sorbate are used in the invention.
A feature of the invention is that the invention contains from 0.01% to 0.4% by weight of acidity regulators. The invention uses 0.04%wt citric acid as acidity regulator.
A feature of the invention is that the invention contains from 30% to 85% by weight of preservatives. The invention uses 72% distilled water by weight as solvent.
A feature of the invention is that the invention contains from 0.02% to 2% by weight of sweeteners. Sugar, sodium saccharin, aspartame, sorbitol, xylitol, menthol and flavors in the art can be used as sweeteners. The invention uses 0.3% by weight vanilla and hazelnut flavors.
Another feature of the herbal composition in the invention is that it is in suspension, syrup or emulsion dosage forms.
The object of the invention, The production method of developed herbal composition involves comprises distillation of plants, weighing of auxiliary substances, the mixing steps for dispensing / dispersing the active agents (plants), addition of adjuvants and mixing for homogenization.
Another feature of the production method of the invention is that all components are individually weighed under a laminar flow system.
The production method of the herbal composition that is developed comprises the following steps:
• Distillation of the plants (urtica dioica, serenoa repens, aesculus hippocastanum, cucurbita pepo) in the distillation facility, and their transfer to the liquid tank,
• Dispersion of xanthan gum upon the distillate,
• Mixing for 30 minutes
• PEG addition
• Adddition of sodium benzoate, potassium sorbate, citric acid, sucralose, vanilla/hazelnut flavors in this order, while mixing continues,
• Mixing for 20 minutes
Another feature of the production process of the invention is the addition of distilled plants in sequence. • Serenoa repens
• Aesculus hippocastanum
• Cucurbita pepo
• Urtica dioica
For a better understanding of the formulation of the invention, an exemplary formulation is provided in suspension form using the production method above using the component and weight ratios given in Table 1 below.
Table 1: Example formulation
Figure imgf000007_0001

Claims

1. The invention discloses a pharmaceutical herbal composition comprising to comprehensively eliminate chronic urinary retention symptoms in patients with BPH and/or prostate adenoma, and its feature is that it contains urtica dioica (nettle), serenoea repens (dwarf palm), aesculus hippocastanum (horse chestnut) and cucurbita pepo (squash).
2. A herbal composition according to claim 1, characterized in that it comprises urtica dioica in the range of 0.1 to 25%, serenoa repens in the range of 1-30%, aesculus hippocastanum in the range of 1-36%, cucurbita pepo in the range of 2-31% by weight.
3. A herbal composition according to claim 2, characterized in that it comprises urtica dioica in the range of 5% to 24%, serenoa repens in the range of 1% - 15%, aesculus hippocastanum in the range of 1.5% - 25%, cucurbita pepo in the range of 2% - 22% by weight.
4. A herbal composition according to claim 3, comprising viscosifiers, solubilizing, preservatives, acidity regulating agents and solvents as adjuvants.
5. A herbalcomposition according to claim 4, characterized in that it comprises from 0.01% to 0.1% by weight of viscosifier.
6. A herbalcomposition according to claim 5, characterized in that it comprises from 0.08% by weight of xanthan gum.
7. A herbal composition according to claim 4, characterized in that it comprises from 1% to 10% by weight of solubilizing.
8. A herbal composition according to claim 7, characterized in that it comprises 4% by weight of PEG400.
9. A herbal composition according to claim 4, characterized in that it comprises from 0.01% to 0.9% by weight of preservatives.
10. A herbal composition according to claim 9, characterized in that it comprises 0.08% by weight of sodium benzoate and .0.06% by weight of potassium sorbate.
11. A herbal composition according to claim 4, characterized in that it comprises from 0.01% to 0.4% by weight of acidity regulating agent.
12. A herbal composition according to claim 11, characterized in that it comprises from 0.04% by weight of citric acid.
13. A herbal composition according to claim 4, characterized in that it comprises from 30% to 85% by weight of solvents.
14. A herbal composition according to claim 13, characterized in that it comprises 72% by weight of distilled water.
15. A herbal composition according to claim 4, characterized in that it comprises from 0.02% to 2% by weight of sweeteners.
16. A herbal composition according to claim 15, characterized in that it contains 0.3% by weight of vanilla and hazelnut flavors.
17. A herbal composition according to any one of the preceding claims, characterized in that it is in a suspension, syrup or emulsion dosage form.
18. The production method of the herbal composition comprising involves distillation of plants, weighing of auxiliary substances, the mixing steps for dispensing / dispersing the active agents (plants), addition of adjuvants and mixing for homogenization urtica dioica (nettle), serenoa repens (dwarf palm), aesculus hippocastanum (horse chestnut), cucurbita pepo (squash) according to the invention.
19. The production method of the herbal composition according to claim 18, comprises the step of all components are individually weighed under a laminar flow system.
20. The production method of a herbal composition according to claim 18, comprises the steps of;
• the plants (urtica dioica, serenoa repens, aesculus hippocastanum, cucurbita pepo) are distilled in the distillation facility, and transferred to the liquid tank,
• xanthan gum is dispersed upon the distillate,
• mixed for 30 minutes,
• PEG is added
• sodium benzoate, potassium sorbate, citric acid, sucralose, vanilla/hazelnut flavors are added in this order, while mixing continues,
• mixed again for 20 minutes.
21. The production method of a herbal composition according to claim 18, comprises the steps of the plants are distilled in sequence: serenoa repens, aesculus hippocastanum, cucurbita pepo, urtica dioica.
PCT/TR2018/050757 2018-11-22 2018-12-03 Developed herbal composition for use on bph (benign prostate hyperplasia) and/or prostate adenoma WO2020106233A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6241987B1 (en) * 1998-08-20 2001-06-05 Amway Corporation Dietary supplement containing saw palmetto, pumpkin seed, and nettle root
WO2017164707A1 (en) 2016-03-24 2017-09-28 주식회사 케미메디 Pharmaceutical composition and dietary supplement for preventing or treating overactive bladder caused by secondary bladder degeneration due to bladder outlet obstruction caused by benign prostatic hyperplasia

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6241987B1 (en) * 1998-08-20 2001-06-05 Amway Corporation Dietary supplement containing saw palmetto, pumpkin seed, and nettle root
WO2017164707A1 (en) 2016-03-24 2017-09-28 주식회사 케미메디 Pharmaceutical composition and dietary supplement for preventing or treating overactive bladder caused by secondary bladder degeneration due to bladder outlet obstruction caused by benign prostatic hyperplasia

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Title
"Herbal medicines", 2007, PHARMACEUTICAL PRESS, ISBN: 978-0-85369-623-0, article JOANNE BARNES ET AL: "Herbal Medicines Third edition Horse-chestnut Summary and Pharmaceutical Comment", pages: 363 - 366, XP055632610 *
BEDAR M: "HORSE CHESTNUT: HELPFUL FOR VARICOSE VEINS?", CPJ. CANADIAN PHARMACEUTICAL JOURNAL, CANADIAN PHARMACEUTICAL ASSOCIATION, OTTAWA, CA, vol. 135, no. 6, July 2002 (2002-07-01), pages 41/42, XP009043469, ISSN: 0828-6914 *
TSAI YSTONG YCCHENG JTLEE CHYANG FSLEE HY: "Pumpkin seed oil and phytosterol-F can block testosterone/prazosin-induced prostate growth in rats", UROL INT., vol. 77, no. 3, 2006, pages 269 - 74

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