WO2024079757A1 - A herbal composition for erectile dysfunction - Google Patents
A herbal composition for erectile dysfunction Download PDFInfo
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- WO2024079757A1 WO2024079757A1 PCT/IN2023/050940 IN2023050940W WO2024079757A1 WO 2024079757 A1 WO2024079757 A1 WO 2024079757A1 IN 2023050940 W IN2023050940 W IN 2023050940W WO 2024079757 A1 WO2024079757 A1 WO 2024079757A1
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- herbal composition
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- succinate salt
- herbal
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- 239000000203 mixture Substances 0.000 title claims abstract description 60
- 201000001881 impotence Diseases 0.000 title claims description 24
- 208000010228 Erectile Dysfunction Diseases 0.000 title claims description 23
- 241000652475 Euphorbia royleana Species 0.000 claims abstract description 21
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 16
- 238000000034 method Methods 0.000 claims abstract description 9
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- FALRKNHUBBKYCC-UHFFFAOYSA-N 2-(chloromethyl)pyridine-3-carbonitrile Chemical compound ClCC1=NC=CC=C1C#N FALRKNHUBBKYCC-UHFFFAOYSA-N 0.000 claims description 3
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Classifications
-
- 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)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- 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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- 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
- A61K47/30—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
- A61K47/38—Cellulose; Derivatives thereof
Definitions
- the present invention relates to a herbal composition for the treatment of erectile dysfunction. More particularly, the present invention relates to herbal composition comprising the succinate salt of extract of Euphorbia royleana plant fibrous exudate along with acceptable pharmaceutical excipients. The present invention also relates to process for preparation of said herbal composition.
- Erectile dysfunction is a serious health problem characterized by the inability to achieve and maintain a penile erection sufficient for stimulating sexual intercourse. Millions of men around the world suffer from erectile dysfunction. Globally, the prevalence of erectile dysfunction is very high, with estimated incidence ranging from 2% in men under the age of 40 and 86% in men over the age of 80 (Prins et al. 2002).
- Erectile dysfunction can result from disruption of many physiological or psychological factors that maintain a balance between blood flow to and from the penis, causing a rigid expansion of the corpus cavemosum and trabecular bone. Erectile dysfunction is sometimes associated with prostate surgery or treatments related to prostate problems wherein many men suffer from erectile dysfunction in the first few months after treatment. This is because the nerves and blood vessels that control the physical aspects of an erection are very delicate, and any trauma (such as surgery) to this area causes changes in the natural order. There are many surgical and pharmacological treatments available to cure erectile dysfunction. Pharmacological treatments include several effective drugs available orally or topically.
- WO2010044094 discloses a topical composition for treatment of erectile dysfunction and pulmonary arterial hypertension (PAH) comprising pharmaceutically effective amount of l-[[3-(6,7-dihydro-l-methyl-7-oxo-3-propyl- IH-pyrazolo[4,3-pyrimidin-5-yl)-4 ethoxyphenyl] sulfonyl] -4-methyl piperazine citrate and desensitizing agent along with pharmaceutically acceptable excipients.
- PAH pulmonary arterial hypertension
- Panax quinquefolius L. Eurycoma longifolia, Corynanthe yohimbe, Maca, Ginkgo biloba, Tumeria diffusa, Terminalia catappa L., Tribulus terrestris, Euphorbia Hirta L., Passiflora incamata L.
- Plant based herbal compositions offer an alternative therapy for the treatment of erectile dysfunction because of their efficacy, accessibility and affordability.
- Euphorbia royleana a succulent and has cactus like in appearance is a species of flowering plant in the family Euphorbiaceae.
- the areal parts of this plant is traditionally used for treatment of many ailments breathing disorders including asthma, bronchitis, and chest congestion including paralysis, ear pain, loose motions, for mucus in the nose and throat, throat spasms, hay fever, and tumors.
- compositions for improving quality, strength and duration of penile erections for prostate surgery candidate before and after a prostate procedure.
- the compositions additionally comprise of ingredients selected from among one or more plants sources such as euphorbia.
- US9486482 discloses synergistic herbal composition comprising extracts of herbal ingredients of Tribulus terrestris, Withania somnifera, Curculigo orchioides, Mucuna pruriens, Asparagus adscendens, Asteracantha longifolia, Asphaltum, and optionally the extracts of Piper longum and Anacyclus pyrethrum for the treatment of disorders associated with Male sexual Dysfunction.
- CN111789904 discloses prostate maintenance spray comprising euphorbia kansui, safflower, angelica, plantain seed, pumpkin seed, gentian, alisma orientale, rehmannia root, akebia stem, mint and water useful to improve sexual dysfunction.
- CN108159263 discloses a composition for treating impotence and premature ejaculation comprising Safflower, Euphorbia Hylonoma, cynomorium songaricum, Morinda officinalis, radix achyranthis bidentatae, day hero, Semen Cuscutae, testiset penis phocae, tortoise glue, deer horn glue, angelica tail, fructus comi, Radix Rehmanniae, matrimony vine, cultivated land, ginseng, ganoderma lucidum, flat stem astragalus, agalloch eaglewood, Cortex Eucommiae, Radix Polygalae, sealwort, teasel root, Herba Cistanches, Radix Notoginseng, longspur epimedium and Ma Ka.
- compositions show side effects such as stomach disorder, blurry vision, increased risk of bleeding, and urinary tract infections. They also leave bitter taste in the mouth after administration.
- the present inventor has come up with a herbal composition comprising the succinate salt of water extract of Euphorbia royleana plant fibrous exudate which is safe, shows improved efficacy in the treatment of erectile dysfunction and has minimal side effects.
- a herbal composition comprising the succinate salt of water extract of Euphorbia royleana plant fibrous exudate which is safe, shows improved efficacy in the treatment of erectile dysfunction and has minimal side effects.
- an object of the present invention is to provide a herbal composition for treatment of erectile dysfunction.
- Another object of the present invention is to provide a herbal composition having good storage stability.
- Another object of the present invention is to provides a herbal composition comprising salt of extract of fibrous exudate of Euphorbia royleana along with acceptable pharmaceutical excipients for erectile dysfunction.
- the present invention provides a herbal composition for erectile dysfunction.
- the present invention provides a herbal composition
- a herbal composition comprising the succinate salt of extract of Euphorbia royleana plant fibrous exudate along with acceptable excipients for erectile dysfunction.
- the herbal composition of the present invention may be a pharmaceutical or nutraceutical composition.
- the pharmaceutical/nutraceutical excipients in the composition comprise the Penetration enhancer, surfactant and solubilizer such as Epocutol (Diethylene Glycol Monoethyl Ether)
- the herbal composition of the present invention further comprises the acceptable excipients selected from Antioxidant, perfuming agent, chelating agent, Rheology modifier, Humectant, Buffering agent, cathartic, solvent and the like alone or in combinations thereof.
- the herbal composition comprises of Epocutol in an amount of 2-4% w/w, , Propylene glycol in an amount of 5-10% w/w, Hydroxy ethyl cellulose in an amount of 1-8% w/w, Sorbitol in an amount of 2-12%w/w, Propyl gallate in an amount of 0.01-0.09% w/w, Sodium phosphate in an amount of 2-7% w/w, Disodium phosphate in an amount of 4-8% w/w, Ethylenediamine tetraacetic acid (EDTA) in an amount of 0. 15-0.30% w/w and water. .
- Epocutol in an amount of 2-4% w/w
- Propylene glycol in an amount of 5-10% w/w
- Hydroxy ethyl cellulose in an amount of 1-8% w/w
- Sorbitol in an amount of 2-12%w/w
- Propyl gallate in an amount of 0.01-0.09% w/
- the herbal composition comprises of Epocutol 2%, Propylene glycol 6%, Hydroxy ethyl cellulose 3%, Sorbitol 5%, Propyl gallate 0.05%, Sodium phosphate 5%, Disodium phosphate 7%, Ethylenediamine tetraacetic acid (EDTA) 0.25% and water.
- the herbal composition of the present invention is a colorless jelly.
- the present invention provides a process for preparing succinate salt of extract of Euphorbia royleana plant comprising;
- step (iii) adding succinic anhydride to the aqueous extract of step (ii) to obtain the product.
- the concentration of the actives present in the aqueous extract ranges between 5-20%w/w.
- the present invention provides a method of formulating the succinate salt of extract of Euphorbia royleana fibrous exudate into jelly composition comprising adding in suitable amounts the pharmaceutical/ nutraceutical excipients to said succinate salt extract.
- the herbal composition of the present invention shows excellent stability at ambient temperature.
- Source of biological material used in the invention is a source of biological material used in the invention.
- Euphorbia royleana is obtained from Himalayan foot hills of India.
- the present invention relates to a herbal composition
- a herbal composition comprising the succinate salt of extract of Euphorbia royleana plant fibrous exudate along with acceptable excipients for erectile dysfunction.
- the aqueous extracts comprise the succinate salt of flavonoids.
- the pharmaceutical/ nutraceutical excipients in the composition comprise the penetration agent, surfactant and solubilizer such as Epocutol (Diethylene Glycol Monoethyl Ether).
- the herbal composition of the present invention further comprises the acceptable excipients selected from antioxidant, perfuming agent, chelating agent, penetration enhancer, surfactant, solubilizer, Rheology modifier, Humectant, Buffering agent and cathartic in appropriate amounts.
- the present invention discloses a herbal jelly composition, comprising: i. Succinate salt of extract of Euphorbia royleana plant as an active in an amount of 5-20%w/w; ii. EPOCUTOL in an amount of 2-4%w/w; iii. Propylene glycol in an amount of 5-10%w/w; iv. Hydroxy ethyl cellulose in an amount of l-8%w/w, v. Sorbitol in an amount of 2-12%w/w, vi. Propyl gallate in an amount of 0.01-0.09%w/w, vii. Sodium phosphate in an amount of 2-7%w/w, viii. Disodium phosphate in an amount of 4-8%w/w, ix. EDTA in an amount of 0.15-0.30%w/w, and x. water q.s.
- the present invention disclose herbal jelly composition, comprising: i. Succinate salt of extract of Euphorbia royleana plant as an active in an amount of 12%; ii. EPOCUTOL in an amount of 2% iii. Propylene glycol in an amount of 6%; iv. Hydroxy ethyl cellulose in an amount of 3%, v. Sorbitol in an amount of 5%, vi. Propyl gallate in an amount of 0.05 %, vii. Sodium phosphate in an amount of 5%, viii. Disodium phosphate in an amount of 7%, ix. EDTA in an amount of 0.25%, and x. water q.s.
- the herbal composition of the present invention is a colorless jelly. This helps in better bioavailability and better absorption of the active ingredient.
- the jelly composition of the present invention is administered orally.
- the present invention discloses a process for preparing succinate salt of extract of Euphorbia royleana plant comprising;
- step (iii) adding succinic anhydride to the aqueous extract of step (ii) to obtain the product.
- the present invention discloses a method of formulating the succinate salt of extract of Euphorbia royleana fibrous exudate into jelly composition comprising adding in suitable amounts the pharmaceutical/nutraceutical excipients to said succinate salt extract.
- the herbal composition of the present invention shows excellent stability at ambient temperature.
- the herbal composition of the present invention may be administered to a subject in need in suitable dosages.
- the present invention relates to the use of the herbal composition for treating erectile dysfunction.
- the present invention discloses a method for treating erectile dysfunction in the subject comprising providing the herbal composition in an effective amount.
- the present pharmaceutical composition is suitable for use in patients having a decreased ability to swallow and patients whose intake of water has been restricted. ii.
- the present pharmaceutical composition exhibits excellent storage stability. iii.
- the present pharmaceutical composition is safe and has little to no side effects.
- Example 1 - HERBAL JELLY COMPOSITION
- Example 2 HERBAL JELLY COMPOSITION
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Abstract
Disclosed herein is a herbal composition comprising Euphorbia royleana succinate and suitable pharmaceutical excipients. The invention also disclosed herein is process for preparation of said herbal composition.
Description
“A HERBAL COMPOSITION FOR ERECTILE DYSFUNCTION”
TECHNICAL FIELD OF THE INVENTION:
The present invention relates to a herbal composition for the treatment of erectile dysfunction. More particularly, the present invention relates to herbal composition comprising the succinate salt of extract of Euphorbia royleana plant fibrous exudate along with acceptable pharmaceutical excipients. The present invention also relates to process for preparation of said herbal composition.
BACKGROUND AND PRIOR ART:
Erectile dysfunction is a serious health problem characterized by the inability to achieve and maintain a penile erection sufficient for stimulating sexual intercourse. Millions of men around the world suffer from erectile dysfunction. Globally, the prevalence of erectile dysfunction is very high, with estimated incidence ranging from 2% in men under the age of 40 and 86% in men over the age of 80 (Prins et al. 2002).
There are two major causes for the erectile dysfunction: psychogenic and organic causes. Erectile dysfunction can result from disruption of many physiological or psychological factors that maintain a balance between blood flow to and from the penis, causing a rigid expansion of the corpus cavemosum and trabecular bone. Erectile dysfunction is sometimes associated with prostate surgery or treatments related to prostate problems wherein many men suffer from erectile dysfunction in the first few months after treatment. This is because the nerves and blood vessels that control the physical aspects of an erection are very delicate, and any trauma (such as surgery) to this area causes changes in the natural order.
There are many surgical and pharmacological treatments available to cure erectile dysfunction. Pharmacological treatments include several effective drugs available orally or topically.
WO2010044094 discloses a topical composition for treatment of erectile dysfunction and pulmonary arterial hypertension (PAH) comprising pharmaceutically effective amount of l-[[3-(6,7-dihydro-l-methyl-7-oxo-3-propyl- IH-pyrazolo[4,3-pyrimidin-5-yl)-4 ethoxyphenyl] sulfonyl] -4-methyl piperazine citrate and desensitizing agent along with pharmaceutically acceptable excipients.
Many plants have the ability to treat sexual dysfunction. Among them are Panax quinquefolius L., Eurycoma longifolia, Corynanthe yohimbe, Maca, Ginkgo biloba, Tumeria diffusa, Terminalia catappa L., Tribulus terrestris, Euphorbia Hirta L., Passiflora incamata L. Plant based herbal compositions offer an alternative therapy for the treatment of erectile dysfunction because of their efficacy, accessibility and affordability.
Euphorbia royleana, a succulent and has cactus like in appearance is a species of flowering plant in the family Euphorbiaceae. The areal parts of this plant is traditionally used for treatment of many ailments breathing disorders including asthma, bronchitis, and chest congestion including paralysis, ear pain, loose motions, for mucus in the nose and throat, throat spasms, hay fever, and tumors.
US20160206673 discloses methods and compositions for improving quality, strength and duration of penile erections for prostate surgery candidate before and after a prostate procedure. The compositions additionally comprise of ingredients selected from among one or more plants sources such as euphorbia.
US9486482 discloses synergistic herbal composition comprising extracts of herbal ingredients of Tribulus terrestris, Withania somnifera, Curculigo orchioides, Mucuna pruriens, Asparagus adscendens, Asteracantha longifolia,
Asphaltum, and optionally the extracts of Piper longum and Anacyclus pyrethrum for the treatment of disorders associated with Male Sexual Dysfunction.
CN111789904 discloses prostate maintenance spray comprising euphorbia kansui, safflower, angelica, plantain seed, pumpkin seed, gentian, alisma orientale, rehmannia root, akebia stem, mint and water useful to improve sexual dysfunction.
CN108159263 discloses a composition for treating impotence and premature ejaculation comprising Safflower, Euphorbia Hylonoma, cynomorium songaricum, Morinda officinalis, radix achyranthis bidentatae, day hero, Semen Cuscutae, testiset penis phocae, tortoise glue, deer horn glue, angelica tail, fructus comi, Radix Rehmanniae, matrimony vine, cultivated land, ginseng, ganoderma lucidum, flat stem astragalus, agalloch eaglewood, Cortex Eucommiae, Radix Polygalae, sealwort, teasel root, Herba Cistanches, Radix Notoginseng, longspur epimedium and Ma Ka.
However, the above compositions show side effects such as stomach disorder, blurry vision, increased risk of bleeding, and urinary tract infections. They also leave bitter taste in the mouth after administration.
Therefore, there is a need for providing a herbal composition that improves sexual performance in an individual by overcoming the limitations and disadvantages of the prior art.
Hence, the present inventor has come up with a herbal composition comprising the succinate salt of water extract of Euphorbia royleana plant fibrous exudate which is safe, shows improved efficacy in the treatment of erectile dysfunction and has minimal side effects.
OBJECT OF INVENTION
Accordingly, an object of the present invention is to provide a herbal composition for treatment of erectile dysfunction.
Another object of the present invention is to provide a herbal composition having good storage stability.
Another object of the present invention is to provides a herbal composition comprising salt of extract of fibrous exudate of Euphorbia royleana along with acceptable pharmaceutical excipients for erectile dysfunction.
SUMMARY OF THE INVENTION:
In line with the above objectives, the present invention provides a herbal composition for erectile dysfunction.
Accordingly, the present invention provides a herbal composition comprising the succinate salt of extract of Euphorbia royleana plant fibrous exudate along with acceptable excipients for erectile dysfunction.
The herbal composition of the present invention may be a pharmaceutical or nutraceutical composition.
The pharmaceutical/nutraceutical excipients in the composition comprise the Penetration enhancer, surfactant and solubilizer such as Epocutol (Diethylene Glycol Monoethyl Ether)
The herbal composition of the present invention further comprises the acceptable excipients selected from Antioxidant, perfuming agent, chelating agent, Rheology
modifier, Humectant, Buffering agent, cathartic, solvent and the like alone or in combinations thereof.
In an aspect, the herbal composition comprises of Epocutol in an amount of 2-4% w/w, , Propylene glycol in an amount of 5-10% w/w, Hydroxy ethyl cellulose in an amount of 1-8% w/w, Sorbitol in an amount of 2-12%w/w, Propyl gallate in an amount of 0.01-0.09% w/w, Sodium phosphate in an amount of 2-7% w/w, Disodium phosphate in an amount of 4-8% w/w, Ethylenediamine tetraacetic acid (EDTA) in an amount of 0. 15-0.30% w/w and water. .
In a preferable aspect, the herbal composition comprises of Epocutol 2%, Propylene glycol 6%, Hydroxy ethyl cellulose 3%, Sorbitol 5%, Propyl gallate 0.05%, Sodium phosphate 5%, Disodium phosphate 7%, Ethylenediamine tetraacetic acid (EDTA) 0.25% and water.
In an aspect, the herbal composition of the present invention is a colorless jelly.
In another aspect, the present invention provides a process for preparing succinate salt of extract of Euphorbia royleana plant comprising;
(i) Separating the fibrous exudate from Euphorbia royleana plant;
(ii) Extracting the fibrous exudate with water; and
(iii) adding succinic anhydride to the aqueous extract of step (ii) to obtain the product.
In an aspect, the concentration of the actives present in the aqueous extract ranges between 5-20%w/w.
In yet another aspect, the present invention provides a method of formulating the succinate salt of extract of Euphorbia royleana fibrous exudate into jelly composition comprising adding in suitable amounts the pharmaceutical/ nutraceutical excipients to said succinate salt extract.
The herbal composition of the present invention shows excellent stability at ambient temperature.
DETAILED DESCRIPTION OF THE INVENTION:
The invention will now be described in detail in connection with certain preferred and optional embodiments, so that various aspects thereof may be more fully understood and appreciated.
Source of biological material used in the invention:
Euphorbia royleana is obtained from Himalayan foot hills of India.
In an embodiment, the present invention relates to a herbal composition comprising the succinate salt of extract of Euphorbia royleana plant fibrous exudate along with acceptable excipients for erectile dysfunction.
In an embodiment, the aqueous extracts comprise the succinate salt of flavonoids.
The pharmaceutical/ nutraceutical excipients in the composition comprise the penetration agent, surfactant and solubilizer such as Epocutol (Diethylene Glycol Monoethyl Ether).
The herbal composition of the present invention further comprises the acceptable excipients selected from antioxidant, perfuming agent, chelating agent, penetration enhancer, surfactant, solubilizer, Rheology modifier, Humectant, Buffering agent and cathartic in appropriate amounts.
Accordingly, the present invention discloses a herbal jelly composition, comprising:
i. Succinate salt of extract of Euphorbia royleana plant as an active in an amount of 5-20%w/w; ii. EPOCUTOL in an amount of 2-4%w/w; iii. Propylene glycol in an amount of 5-10%w/w; iv. Hydroxy ethyl cellulose in an amount of l-8%w/w, v. Sorbitol in an amount of 2-12%w/w, vi. Propyl gallate in an amount of 0.01-0.09%w/w, vii. Sodium phosphate in an amount of 2-7%w/w, viii. Disodium phosphate in an amount of 4-8%w/w, ix. EDTA in an amount of 0.15-0.30%w/w, and x. water q.s.
In a preferred embodiment, the present invention disclose herbal jelly composition, comprising: i. Succinate salt of extract of Euphorbia royleana plant as an active in an amount of 12%; ii. EPOCUTOL in an amount of 2% iii. Propylene glycol in an amount of 6%; iv. Hydroxy ethyl cellulose in an amount of 3%, v. Sorbitol in an amount of 5%, vi. Propyl gallate in an amount of 0.05 %, vii. Sodium phosphate in an amount of 5%, viii. Disodium phosphate in an amount of 7%, ix. EDTA in an amount of 0.25%, and x. water q.s.
In an embodiment, the herbal composition of the present invention is a colorless jelly. This helps in better bioavailability and better absorption of the active ingredient.
In yet another embodiment, the jelly composition of the present invention is administered orally.
In another embodiment, the present invention discloses a process for preparing succinate salt of extract of Euphorbia royleana plant comprising;
(i) Separating the fibrous exudate from Euphorbia royleana plant;
(ii) Extracting the fibrous exudate with water; and
(iii) adding succinic anhydride to the aqueous extract of step (ii) to obtain the product.
In yet another embodiment, the present invention discloses a method of formulating the succinate salt of extract of Euphorbia royleana fibrous exudate into jelly composition comprising adding in suitable amounts the pharmaceutical/nutraceutical excipients to said succinate salt extract.
The herbal composition of the present invention shows excellent stability at ambient temperature.
The herbal composition of the present invention may be administered to a subject in need in suitable dosages.
In an embodiment, the present invention relates to the use of the herbal composition for treating erectile dysfunction.
In yet another embodiment, the present invention discloses a method for treating erectile dysfunction in the subject comprising providing the herbal composition in an effective amount.
ADVANTAGES OF THE INVENTION i. The present pharmaceutical composition is suitable for use in patients having a decreased ability to swallow and patients whose intake of water has been restricted.
ii. The present pharmaceutical composition exhibits excellent storage stability. iii. The present pharmaceutical composition is safe and has little to no side effects. The following examples which includes preferred embodiments, will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of example and for purpose of illustrative discussion of preferred embodiments of the invention.
Examples:
Example 1 - HERBAL JELLY COMPOSITION
Example 2: HERBAL JELLY COMPOSITION
Example 3- Characterization of the Jelly composition
Although the invention has been described in detail in the foregoing for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that variations can be made therein by those skilled in the art without departing from the spirit and scope of the invention except as it may be limited by the claims.
Claims
1. An herbal composition comprising the succinate salt of aqueous extract of the fibrous exudate of Euphorbia royleana in an amount of 5-20% w/w along with acceptable excipients.
2. The herbal composition as claimed in claim 1, wherein the fibrous exudate is obtained from leaves, flowers and stem.
3. The herbal composition as claimed in claim 1, wherein the excipients are selected from antioxidant, chelating agent, penetration enhancer, surfactant, solubilizer, Rheology modifier, Humectant, Buffering agent, perfuming agent and cathartic in appropriate amounts alone or in combinations thereof .
4. The herbal composition as claimed in claim 3, wherein the excipients comprises Epocutol, Propylene glycol, Hydroxy ethyl cellulose, Sorbitol, Propyl gallate, Sodium phosphate, Disodium phosphate, Ethylenediamine tetraacetic acid (EDTA) and the like in appropriate amounts alone or in combinations thereof .
5. The herbal composition as claimed in claims 1 to 4, comprising; i. Succinate salt of aqueous extract of fibrous exudate of Euphorbia royleana plant as an active in an amount of 5-20%w/w; ii. EPOCUTOL in an amount of 2-4%w/w; iii. Propylene glycol in an amount of 5-10%w/w; iv. Hydroxy ethyl cellulose in an amount of l-8%w/w, v. Sorbitol in an amount of 2- 12%w/w, vi. Propyl gallate in an amount of 0.01-0.09%w/w, vii. Sodium phosphate in an amount of 2-7%w/w, viii. Disodium phosphate in an amount of 4-8%w/w, ix. EDTA in an amount of 0.15-0.30%w/w, and x. water q.s.
6. The herbal composition as claimed in claim 5, comprising; i. Succinate salt of aqueous extract of fibrous exudate of Euphorbia royleana plant as an active in an amount of 12%;
ii. EPOCUTOL in an amount of 2% iii. Propylene glycol in an amount of 6%; iv. Hydroxy ethyl cellulose in an amount of 3%, v. Sorbitol in an amount of 5%, vi. Propyl gallate in an amount of 0.05 %, vii. Sodium phosphate in an amount of 5%, viii. Disodium phosphate in an amount of 7%, ix. EDTA in an amount of 0.25%, and x. water q.s.
7. The herbal composition as claimed in any one of the claims 1 to 6 , wherein the composition is in the form of colorless jelly.
8. The herbal composition as claimed in any of the preceding claims, wherein the succinate salt of the extract is prepared by a process comprising; i. Separating the fibrous exudate from Euphorbia royleana plant; ii. Extracting the fibrous exudate with water; and iii. adding succinic anhydride to the aqueous extract of step (ii) to obtain the product.
9. The herbal composition as claimed in any of the preceding claims, wherein the composition is prepared by mixing the suitable excipients to the succinate salt of the extract of Euphorbia royleana.
10. The herbal composition as claimed in claim 1, wherein the composition may be pharmaceutical or nutraceutical.
11. Use of the herbal composition as claimed in any one of the preceding claims for erectile dysfunction.
12. A method for treating erectile dysfunction in a subject comprising administering an effective amount of the herbal composition as claimed in any one of the preceding claims.
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| CN104983616A (en) * | 2015-06-26 | 2015-10-21 | 东方福尚福养生有限公司 | Human body lubricating fluid and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| AISHA ASHRAF: "Antioxidant, antimicrobial, antitumor, and cytotoxic activities of an important medicinal plant (Euphorbia royleana) from Pakistan", JOURNAL OF FOOD AND DRUG ANALYSIS, TAIBEI, TW, vol. 23, no. 1, 1 March 2015 (2015-03-01), TW , pages 109 - 115, XP093164250, ISSN: 1021-9498, DOI: 10.1016/j.jfda.2014.05.007 * |
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