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US20180153949A1 - Composition, containing quisaqualis indica extract, for preventing or treating prostatic hyperplasia - Google Patents

Composition, containing quisaqualis indica extract, for preventing or treating prostatic hyperplasia Download PDF

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Publication number
US20180153949A1
US20180153949A1 US15/574,702 US201615574702A US2018153949A1 US 20180153949 A1 US20180153949 A1 US 20180153949A1 US 201615574702 A US201615574702 A US 201615574702A US 2018153949 A1 US2018153949 A1 US 2018153949A1
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Prior art keywords
prostatic hyperplasia
extract
present disclosure
indica extract
prostate
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Abandoned
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US15/574,702
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English (en)
Inventor
Hyo Jung Kwon
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Industry and Academy Cooperation In Chungnam National University
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Industry and Academy Cooperation In Chungnam National University
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Assigned to THE INDUSTRY & ACADEMIC COOPERATION IN CHUNGNAM NATIONAL UNIVERSITY (IAC) reassignment THE INDUSTRY & ACADEMIC COOPERATION IN CHUNGNAM NATIONAL UNIVERSITY (IAC) ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KWON, HYO JUNG
Publication of US20180153949A1 publication Critical patent/US20180153949A1/en
Abandoned legal-status Critical Current

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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
    • 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
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Definitions

  • the present disclosure relates to a pharmaceutical composition
  • a pharmaceutical composition comprising a Quisqualis indica extract as an active ingredient for preventing or treating prostatic hyperplasia, and to a food composition.
  • Benign prostatic hyperplasia is a male disease rapidly occurring in Korean men aged 50 years or older, and recently the number of patients with benign prostatic hyperplasia in Korea is sharply increasing over 20% per year. In the case of this disease, the cause is the overgrowth of smooth cell and epithelial cell in the transition zone of prostate, and various urinary disorders caused by bladder obstruction occur. It is known that one mechanism of prostatic hyperplasia is related to male hormones, testosterone and dihydrotestosterone (DHT).
  • DHT dihydrotestosterone
  • 5-alpha reductase inhibitor expresses an anti-androgenic activity effect by selectively inhibiting the generation of dihydrotestosterone while not affecting testosterone having male hormone activities, and reduces the enlarged prostate without side effects appearing in anticancer hormone drugs, so it is recognized as a drug for safe and causal treatment of urinary disorders.
  • a compound such as finasteride (Proxcar, Merck) which inhibits the generation of dihydrotestosterone in tissue by inhibiting the activity of 5-alpha reductase enzyme is commercially available as a drug for treating prostatic hyperplasia (U.S. Pat. No. 4,377,584, U.S. Pat. No. 4,760,071, Korean Patent Publication No. 2004-0016559).
  • Quisqualis indica is native to India, and grows in southern regions of China and tropical regions.
  • the common name of Quisqualis indica comes from the person called Guo Shijun in a certain province of China, which was told by later generations of medical practitioners that he treated many children's diseases with this drug alone.
  • It has warm properties and tastes sweet, and contains quiscalic acid, triggonelline, pyridine and fatty oil as active ingredients. It is used to kill parasites, and its percentage amounts to about 70%. Besides, it is used to treat roundworms, but its effect is lower than one of killing parasites, and it functions to strengthen stomachs even though its effect is weak.
  • This drug is less toxic, causing no damage to bodies, and is known as being good for children to eat because it tastes sweet (Encyclopedia of Korean Culture).
  • the present disclosure is directed to providing a pharmaceutical composition comprising a Quisqualis indica extract for preventing or treating prostatic hyperplasia, as a natural medicinal substance having effects on the reduction of prostate weight, DHT and epithelial hyperplasia in prostatic hyperplasia.
  • the present disclosure is further directed to providing a food composition comprising the extract.
  • the present disclosure provides a pharmaceutical composition comprising a Quisqualis indica extract as an active ingredient for preventing or treating prostatic hyperplasia.
  • the Quisqualis indica extract includes all extracts prepared with a whole or part of the plant body by a common plant extraction method known in the art.
  • the Quisqualis indica extract is a crude extract, a polar solvent soluble extract, or a non-polar solvent soluble extract.
  • the Quisqualis indica material of the present disclosure is extracted using a polar solvent selected from water, ethanol, lower alcohol having 1 to 4 carbon atoms or their mixed solvent, preferably water or a mixed solvent of water and ethanol, and more preferably, water or a mixed solvent of 1 to 30% (v/v) water and ethanol, whose volumes are about 1 to 100 times, preferably about 2 to 20 times, greater than the sample weight, at 20 to 120° C., preferably 30 to 80° C.
  • a polar solvent selected from water, ethanol, lower alcohol having 1 to 4 carbon atoms or their mixed solvent, preferably water or a mixed solvent of water and ethanol, and more preferably, water or a mixed solvent of 1 to 30% (v/v) water and ethanol, whose volumes are about 1 to 100 times, preferably about 2 to 20 times, greater than the sample weight, at 20 to 120° C., preferably 30 to 80° C.
  • the Quisqualis indica extract has effects on the reduction of prostate weight, DHT which is a factor causing benign prostatic hyperplasia, and prostate epithelial hyperplasia, and thus is effective in treating and preventing prostatic hyperplasia.
  • the present disclosure provides a pharmaceutical composition or a food composition comprising the Quisqualis indica extract as an active ingredient for preventing or treating prostatic hyperplasia.
  • a Quisqualis indica extract is a medicinal substance that has been long eaten or used as herb medication
  • the extracts of the present disclosure extracted therefrom also have no toxicity and side effect problem.
  • the pharmaceutical composition comprising the extract of the present disclosure for preventing or treating prostatic hyperplasia may include the extract in an amount of 0.1 to 50 weight % based on the total weight of the composition.
  • the pharmaceutical composition comprising the extract of the present disclosure may further include appropriate carriers, excipients and diluents commonly used to prepare pharmaceutical compositions.
  • the pharmaceutical dosage form of the extract of the present disclosure may be also used in the form of their pharmaceutically acceptable salt, and may be used alone or in combination with other pharmaceutically active compounds, and used as appropriate mixtures.
  • the pharmaceutical composition comprising the extract according to the present disclosure may be formulated and used by each common method as oral dosage formulations such as powders, granules, tablets, capsules, suspensions, emulsions, syrups and aerosols, external applications, suppositories and sterilized injection solutions.
  • oral dosage formulations such as powders, granules, tablets, capsules, suspensions, emulsions, syrups and aerosols, external applications, suppositories and sterilized injection solutions.
  • the carriers, excipients and diluents that may be included in the composition comprising the extract include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.
  • the pharmaceutical composition is prepared using commonly used diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants and surfactants.
  • a solid formulation for oral administration includes tablets, pills, powders, granules and capsules, and this solid formulation is prepared by mixing the extract with at least one excipient, for example, starch, calcium carbonate, sucrose or lactose, and gelatin.
  • excipients for example, starch, calcium carbonate, sucrose or lactose, and gelatin.
  • lubricants such as magnesium stearate and talc are also used.
  • a liquid formulation for oral use may include suspensions, solutions, emulsions and syrups, and may include commonly used diluents such as water, liquid paraffin as well as many excipients, for example, wetting agents, sweetening agents, flavoring agents and preservatives.
  • the formulation for non-oral administration includes sterilized aqueous solutions, non-aqueous solvents, suspensions, emulsions, freeze-dried formulations and suppositories.
  • propyleneglycol, polyethylene glycol, vegetable oil such as olive oil, and injectable ester such as ethylolate may be used.
  • Witepsol Macrogol, Tween 61, cacao butter, laurin fat and glycerogelatin may be used.
  • a preferable dose of the extract of the present disclosure changes depending on the patient's condition and weight, the degree of disease, the type of medication, and dosing route and period, but may be appropriately selected by those skilled in the art.
  • the extract of the present disclosure is preferably administered at 0.0001 to 100 mg/kg, and preferably 0.001 to 100 mg/kg per day. Single or multiple doses per day may be used, and multiple divided doses may be used. The dose does not limit the scope of the present disclosure in any aspect.
  • the extract of the present disclosure may be administered via various routes. All predictable dosing methods can be used, and the extract may be administered via, for example, oral, rectal or intravenous, intramuscular, subcutaneous, epidural or intracerebroventricular injection route.
  • the present disclosure provides a food composition comprising a Quisqualis indica extract as an active ingredient for preventing or improving prostatic hyperplasia.
  • the food composition is not limited to a particular type of food, and in its functional aspect, may be a health functional food.
  • the “health functional food” refers to food prepared or processed using a raw material or ingredient having good functionality for human body in accordance with Article 6727 of the Health Functional Food Act, and “functional” refers to eating with an aim of obtaining a good effect for health purposes such as nutrient control or biological activity with regard to the structure and function of human body.
  • the food composition for preventing prostatic hyperplasia includes the extract in an amount of 0.01 to 95 weight %, and preferably 1 to 80 weight % based on the total weight of the composition.
  • a health functional food in the form of tablets, capsules, powders, granules, liquids, and pills.
  • the food to which the extract of the present disclosure can be added includes, for example, different types of foods, beverage, gums, teas, vitamin complexes and health functional foods.
  • the extract may be added to the food or beverage.
  • an amount of the extract in the food or beverage may be 0.01 to 15 weight % based on the total food weight, and the extract may be added in an amount of 0.02 to 5 g, preferably 0.3 to 1 g, based on 100 ml of the beverage composition.
  • the beverage composition of the present disclosure may contain other ingredients without any particular limitation, and like common beverage, may contain many flavoring agents or natural carbohydrates as an additional ingredient.
  • natural carbohydrate include monosaccharide, for example, glucose and fructose; disaccharide, for example, maltose and sucrose; and polysaccharide, for example, common sugar such as dextrin and cyclodextrin, and sugar alcohol such as xylitol, sorbitol and erythritol.
  • natural flavoring agents thaumatin, stevia extracts (for example, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) may be advantageously used.
  • An amount of the natural carbohydrate is generally about 1 to 20 g, and preferably about 5 to 12 g based on 100 ml of the composition of the present disclosure.
  • the extract of the present disclosure may contain many nutritional supplements, vitamins, minerals (electrolytes), flavoring agents such as synthetic flavoring agents and natural flavoring agents, coloring agents and mogul agents (cheese, chocolate, etc.), pectic acid and its salt, alginic acid and its salt, organic acid, protective colloid thickening agents, pH regulating agents, stabilizing agents, preservatives, glycerin, alcohol, and carbonating agents used in carbonated beverage.
  • nutritional supplements vitamins, minerals (electrolytes), flavoring agents such as synthetic flavoring agents and natural flavoring agents, coloring agents and mogul agents (cheese, chocolate, etc.), pectic acid and its salt, alginic acid and its salt, organic acid, protective colloid thickening agents, pH regulating agents, stabilizing agents, preservatives, glycerin, alcohol, and carbonating agents used in carbonated beverage.
  • the Quisqualis indica extract of the present disclosure can be usefully used to treat and prevent prostatic hyperplasia by virtue of the effects on the reduction of prostate weight, DHT which is a factor causing benign prostatic hyperplasia, and prostate epithelial hyperplasia.
  • FIG. 1 shows prostate weight changes in prostatic hyperplasia animal models treated with the Quisqualis indica extract.
  • FIG. 2 shows prostate DHT changes in prostatic hyperplasia animal models treated with the Quisqualis indica extract.
  • FIG. 3 shows serum testosterone levels in prostatic hyperplasia animal models treated with the Quisqualis indica extract.
  • FIG. 4 shows histopathological changes of prostate in prostatic hyperplasia animal models treated with the Quisqualis indica extract.
  • FIG. 5 shows evaluation results of toxicity in prostatic hyperplasia animal models treated with the Quisqualis indica extract.
  • TP testosterone propionate
  • the Quisqualis indica extract prepared in Example 1 was orally administered at 150 mg/kg for 4 weeks one hour before TP injection, and finasteride (10 mg/kg), a 5 ⁇ -reductase enzyme inhibitor used to treat prostatic hyperplasia, was administered to the positive control group by the same method.
  • prostate was taken from each group (normal control group; NC, induced prostatic hyperplasia group; BPH, induced prostatic hyperplasia group+ Quisqualis indica extract administered group; BPH+ Quisqualis indica , induced prostatic hyperplasia group+finasteride administered group; BPH+finasteride), and its weight was measured.
  • NC induced prostatic hyperplasia group
  • BPH induced prostatic hyperplasia group+ Quisqualis indica extract administered group
  • BPH+ Quisqualis indica induced prostatic hyperplasia group+finasteride administered group
  • BPH+finasteride induced weight was measured.
  • FIG. 1 shows prostate weight changes in prostatic hyperplasia animal models treated with the Quisqualis indica extract.
  • the prostate weight was significantly reduced in the Quisqualis indica extract administered group (BPH+ Quisqualis indica ) compared to the TP-induced prostatic hyperplasia group (BPH). This showed a similar effect to finasteride that is currently used to treat prostatic hyperplasia.
  • DHT dihydrotestosterone
  • the concentration of the separated protein was measured using Bio-Rad protein assay kit (Bio-Rad, USA) and to measure the DHT concentration in the supernatant, an amount of DHT in prostate was measured according to the manufacturer's method using ELISA kit (Cayman, USA) that specifically responds to DHT. The measured value was converted based on quantitative protein value, and differences were compared by conducting statistical analysis.
  • FIG. 2 shows prostate DHT changes in prostatic hyperplasia animal models treated with the Quisqualis indica extract. As can be seen from FIG. 2 , it was found that the concentration of DHT causing prostatic hyperplasia was significantly reduced in the group administered with the Quisqualis indica extract.
  • the blood separated after the end of the experiment was centrifugally separated at 12,000 rpm for 20 minutes, the supernatant was harvested and serum testosterone levels were measured using ELISA kit (Cayman, USA).
  • FIG. 3 shows serum testosterone levels in prostatic hyperplasia animal models treated with the Quisqualis indica extract. As can be seen from FIG. 3 , the testosterone levels in the group administered with the Quisqualis indica extract were significantly reduced.
  • the prostate dissected after the end of the experiment was fixed with 10% neutral buffered formalin for 24 hours, followed by paraffin embedding.
  • the embedded tissue was sliced 4 ⁇ m in thickness to create a section, which was stained with hematoxylin (Sigma-Aldrich, USA) and eosin Y (Sigma-Aldrich), mounted in mounting medium, and examined using optical microscope.
  • FIG. 4 shows histopathological changes of prostate in prostatic hyperplasia animal models treated with the Quisqualis indica extract.
  • the height and number of epithelial cells greatly increased in the induced prostatic hyperplasia group, while a reduction in epithelial hyperplasia was observed in the group administered with Quisqualis indica extract.
  • the blood separated after the end of the experiment was centrifugally separated at 12,000 rpm for 20 minutes, the supernatant was harvested and general hepatotoxicity indices, ALT (alanine transaminase) and AST (aspartate transaminase) levels in serum were measured.
  • FIG. 5 shows evaluation results of toxicity in prostatic hyperplasia animal models treated with the Quisqualis indica extract. As can be seen from FIG. 5 , when compared to the normal control group, no significant change in ALT and AST was observed in both the induced prostatic hyperplasia group and the Quisqualis indica extract administered group.
  • testosterone propionate was subcutaneously injected into white rats for 4 weeks to induce prostatic hyperplasia, and the Quisqualis indica extract and finasteride which is being used to treat prostatic hyperplasia were administered for 4 weeks. After the end of medication administration, changes were measured as below.
  • DHT dihydrotestosterone
  • the Quisqualis indica extract of the present disclosure has effects on the reduction of prostate weight, DHT which is a factor causing benign prostatic hyperplasia, and prostate epithelial hyperplasia, and thus can be an effective drug for treating prostatic hyperplasia.
  • the ingredients were mixed and filled in hermetic packaging to prepare powder.
  • tableting was performed according to the common tablet preparation method to prepare tablet.
  • gelatin capsule was filled according to the common capsule preparation method to prepare capsule.
  • the ingredients were mixed and heated while shaking at 85° C. for about 1 hour to prepare a solution, which was filtered and put in 2 l sterilized container, followed by hermetical sealing and sterilization, and cold storage, and was used to produce the health food of the present disclosure.

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US15/574,702 2015-05-18 2016-05-03 Composition, containing quisaqualis indica extract, for preventing or treating prostatic hyperplasia Abandoned US20180153949A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020150069047A KR101552813B1 (ko) 2015-05-18 2015-05-18 사군자 추출물을 함유하는 전립선 비대증 예방 또는 치료용 조성물
KR10-2015-0069047 2015-05-18
PCT/KR2016/004653 WO2016186349A2 (fr) 2015-05-18 2016-05-03 Composition, contenant un extrait de quisaqualis indica, pour la prévention ou le traitement de l'hyperplasie prostatique

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US15/574,702 Abandoned US20180153949A1 (en) 2015-05-18 2016-05-03 Composition, containing quisaqualis indica extract, for preventing or treating prostatic hyperplasia
US16/725,608 Active 2036-05-31 US11771726B2 (en) 2015-05-18 2019-12-23 Composition, containing Quisqualis indica extract, for preventing or treating prostatic hyperplasia
US18/058,038 Active US12156895B2 (en) 2015-05-18 2022-11-22 Composition, containing Quisqualis indica extract, for preventing or treating prostatic hyperplasia

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US18/058,038 Active US12156895B2 (en) 2015-05-18 2022-11-22 Composition, containing Quisqualis indica extract, for preventing or treating prostatic hyperplasia

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EP (1) EP3299025B1 (fr)
JP (1) JP6773303B2 (fr)
KR (1) KR101552813B1 (fr)
CN (2) CN119235936A (fr)
ES (1) ES2770979T3 (fr)
MY (1) MY195068A (fr)
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Cited By (1)

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US12156895B2 (en) 2015-05-18 2024-12-03 The Industry & Academic Cooperation In Chungnam National University (Iac) Composition, containing Quisqualis indica extract, for preventing or treating prostatic hyperplasia

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KR20190090910A (ko) 2018-01-26 2019-08-05 최윤식 나노화된 꿀벌 화분을 유효성분으로 포함하는 양성 전립선 비대증 개선용 조성물
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US20200138886A1 (en) 2020-05-07
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US11771726B2 (en) 2023-10-03
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