WO2018222166A2 - Utilisation d'une préparation à base de plantes, contenant de l'huile de lin, dans le traitement de régulation des taux de lipides (graisse) dans le sang - Google Patents

Utilisation d'une préparation à base de plantes, contenant de l'huile de lin, dans le traitement de régulation des taux de lipides (graisse) dans le sang Download PDF

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Publication number
WO2018222166A2
WO2018222166A2 PCT/TR2018/050092 TR2018050092W WO2018222166A2 WO 2018222166 A2 WO2018222166 A2 WO 2018222166A2 TR 2018050092 W TR2018050092 W TR 2018050092W WO 2018222166 A2 WO2018222166 A2 WO 2018222166A2
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WO
WIPO (PCT)
Prior art keywords
linseed oil
oil
herbal
levels
treatment
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Application number
PCT/TR2018/050092
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English (en)
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WO2018222166A9 (fr
WO2018222166A3 (fr
Inventor
Mevlüt Büyükhelvacigi̇l
Original Assignee
Helvacizade Gida İlaç Ki̇mya Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
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Publication of WO2018222166A2 publication Critical patent/WO2018222166A2/fr
Publication of WO2018222166A3 publication Critical patent/WO2018222166A3/fr
Publication of WO2018222166A9 publication Critical patent/WO2018222166A9/fr

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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)
    • A61K36/55—Linaceae (Flax family), e.g. Linum
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics

Definitions

  • the present invention relates to use of an herbal formulation containing linseed oil (Oleum Lini) in the drug industry in the chemical industry.
  • the invention relates to use of an herbal formulation that is prepared with linseed oil being rich in alpha-linolenic acid which is an herbal fatty acid containing Omega 3; that is in the form of a capsule having an antioxidant property, in the regulation of some blood lipid (fat) levels.
  • Omega 3 is an essential fatty acid, it is a fatty acid thatshould be taken from outside to maintain the organism's life as other essential fatty acids and that cannot be synthesised in body. This essential fatty acid should be taken by means of nutrition and supplements into body.
  • ALA that is an herbal fatty acid containing Omega 3 taken from outside into organism can be used as a herbal Omega 3 (ALA) source in those, particularly in vegetarians who cannot use fish oil and functions as an adjuvant in regulating some blood lipid (fat) levels, treatment of chronic constipation, treatment of cardiovascular system disease and mild gastrointestinal discomfort.
  • CN103099755 a shower foam prepared with various herbal materials including linseed that is natural and providing vitality and softness to skin.
  • T he application numbered C N105560646 mentions a herbal mixture comprising nanking cherry, tamarind, banana, dragon's tongue leaf, carageen, R ussian bochniakia plant, J apanese dok roots, Nepal dok roots, radix S crophulariae, radix lithospemi, coffee bean, senna, unripe Inula, orange, pakchoi plantlets, alopecia, senna and peach flowers as well as linseed so as to treat the symptoms such as constipation, irregular bowel movements, hard stool and pellet-like dry stool.
  • Main object of the invention is to be able to use linseed oil formulation in order to regulate some blood lipid (fat) levels.
  • T he formulation comprises Omega 3, highly -linolenic acid (ALA, 18:3n-3) and lignans.
  • Linseed oil causes serum total cholesterol levels to decrease by 15 percent.
  • Use of linseed oil containing highly ALA decreases serum total cholesterol, LDL (low density lipoprotein) levels on people with hyperlipidaemia. F urther, LDL cholesterol levels are decreased on postmenopausal women.
  • T his effect is resulted from S DG (secoisolariciresional diglucoside) composition being precursor of lignans named as enterodiol and enterolactone that is in breasts isolated from linseed, and 33 percent decrease in serum total cholesterol and 73 percent decrease in plaque have been observed.
  • T hese effects of linseed oil clarify the effects inhibiting the development of atherosclerosis and the effects regulating the blood lipid levels.
  • T hus the formulation can be used as adjuvant to the regulation of blood lipid (fat) levels.
  • T he formulation may assist in decreasing thrombosis incidence since it has the antithrombotic effects and the effects reducing aggregation of thrombosis. Therefore, the formulation can be used as adjuvant in the treatment of cardiovascular diseases.
  • Another object of the invention is to provide a formulation containing no chemical substances, and being totally natural and herbal. No heat or chemical treatment is carried out even when the linseed oil used in the content of the formulation is obtained. T hus, active substances, nutritional values, vitamin and minerals in the plant are directly infused into the product without losing them. Another object of the invention is to ensure to minimise the side effects badly affecting the human health by means of the content formed without chemicals. T he side effects affecting only gastro-entero system such as nausea, vomit, diarrhea resulting from the use of totally natural and herbal products is rarely observed.
  • F urther object of the invention is to provide ease of use in terms of patient compliance through the fact that the formed formulation is in the form of capsule. F urthermore, it is advantageous in administrating the dosing in said indications by means of the formed capsule form.
  • T here are oil and lignans being rich in omega-3(ALA) in the linseed.
  • Linseed among the oils obtained through seeds comes into prominence because it has highly -linolenic acid (ALA, 18:3n-3) and lignans. Linseed comprises oil rate of 35-45 percent whose ALA rate is varying between 45-52 percent thereof. ALA is classified as Omega 3 group of fatty acids.
  • Linseed oil exhibits various pharmacological effects due to ALA in its structure. Linseed oil causes serum total cholesterol levels to decrease by 15 percent. Use of linseed oil containing highly ALA decreases serum total cholesterol, LDL (low density lipoprotein) levels on people with hyperlipidaemia. F urther, LD L cholesterol levels are decreased on postmenopausal women. T his effect is resulted from S DG (secoisolariciresional diglucoside) composition being precursor of lignans named as enterodiol and enterolactone that is in breasts isolated from linseed, and 33 percent decrease in serum total cholesterol and 73 percent decrease in plaque have been observed. T hese effects of linseed oil clarify the effects inhibiting the development of atherosclerosis and the effects regulating the blood lipid levels. T hus, the formulation can be used as adjuvant to the regulation of blood lipid (fat) levels.
  • S DG secoisolariciresional diglucoside
  • T he formulation may assist in decreasing thrombosis incidence since it has the antithrombotic effects and the effects reducing aggregation of thrombosis Therefore, the formulation can be used as adjuvant in the treatment of cardiovascular diseases.
  • Linseed oil exhibits antioxidant effects due to ALA therein.
  • F urthermore ALA has suppressor effects on interleukin, TN F (Tumor necrosis factor), leukotriene B4 and polymorphonuclear leukocytes.
  • T hese facts can explain the effects of linseed oil that can inhibit the development of inflammation. it is known that linseed oil can increase calcium absorption. Along with the effect, it has supportive effects on bone health.
  • T he linseed oil not only is a good nutritional source but also improve bowel movement in adults due to fibrous structure therein. Defecation frequency and continuity are regulated on those who uses the linseed oil. T herefore, the formulation can be used as adjuvant to the treatment of chronic constipation and mild gastrointestinal problems.
  • T he linseed oil is important for adults who cannot use fish oil, particularly vegetarians within the scope of the fact that it is supportive in terms of herbal Omega 3.
  • Linseed oil as active substance and dl -tocopherol, dl -tocopheril acetate, glycerine, purified water and gelatine as inactive substance are employed in the formulation, dl -tocopherol and -tocopheril acetate serve as preservative substance, dl -tocopherol and dl -tocopheril acetate are added into the formulation in the ratio of ppm.
  • Bovine gelatine is used so as to maintain the integrity of content.
  • other animal-originated and herbal gelatines can be used.
  • P roduction steps of capsule formulation follows as below: linseed oil, one of the raw materials, is subjected to sieving process. After sieving process, if necessary, breaking process is carried out. After carrying out said process and obtained desired size, the linseed oil is sent to cold pressing unit By means of cold pressing method, extraction of oil from raw material is performed. In said method, it is not exceeded over 55 S3. T he oil obtained through cold pressing unit is held in the mixing and settling tanks before filtering process. Thus, possible particles can be easily separated by means of mixing and settling processes. the extracted oil is fed to the filter unit indoor and at room temperature after mixing and settling tanks. Particles in the oil are filtered in the filter unit if there are. After filtering process, dl - tocopherol and dl -tocopheril acetate as preservative substance are added into the obtained oil. Thus, the mixture of which content is formed, is obtained.
  • the gelatine is prepared in the gelatine preparing unit so as to maintain the integrity of capsule while carrying out these processes.
  • capsules in desired dosages are prepared by means of sending it to capsule producing unit.
  • S aid capsules are gelatine capsules.
  • the capsule is rich in alpha-linolenic acid (ALA) being O mega 3 that is herbal. It is adjuvant to the treatment of patients with chronic constipation. F urther, it is adjuvant to the treatment of cardio-vascular system diseases, regulating some blood lipid (fat) levels and mild gastrointestinal problems. T he capsule can be used as a herbal Omega 3 (ALA) source on those who cannot use fish oil, particularly on vegetarians.
  • ALA alpha-linolenic acid
  • Dos ing admin istration frequency and period As long as doctor recommends otherwise; the capsules are taken orally as 2-4 capsules (1250-2500 mg/day at dose) per day by adults (aged 18 and older). The capsule can be taken as 1 -2 capsules 1250 mg/day) by children over 12 years of age.
  • R enal/liver failure T he capsules should not be used on the patients with R enal and liver failure because sufficient safety study has not been performed.
  • C ontraindications - Active substance Linseed or any component that the capsule contains should not be used on those who have allergic thereto;
  • E ach capsule contains 0, 161 g of glycerine. It is not expected to appear any side effects resulting from the glycerine at this ratio.
  • T he capsule should be carefully used in the course of the treatment of hormone-related tumors due to its oestrogenic effect.
  • I P regnancy period T he capsule should not be used because no study related to this matter has been performed.
  • I G astrointestinal Diseases C ommonly meteorism and rarely hypersensitivity reactions similarto anaphylaxis can be observed along with the use of capsule. F urther, nausea, vomit and diarrhea can be observed, however its frequency is not known.
  • T here is no reported overdose related to linseed oil.
  • the linseed oil orally taken can be tolerated well. However, it is reported that if the linseed itself is taken orally, abdominal problems such as overdose- related gas and bloating may occur. If any findings occur subsequent to overdose, the treatment should be symptomatic and supportive. There is no specific antidote and elimination enhancement method.
  • S helf life of the product is determined as 2 years.
  • G MP G ood Manufacturing P ractices
  • This product has been approved by a health authority, such as the Ministry of Health, by licensing the SPI (Short Product Information-Prospectus) and UI (Use Instructions) of a Traditional Herbal Medical product
  • a health authority such as the Ministry of Health by standardizing and licensing the usage and dosing of a Traditional Herbal Medicinal product.
  • the traditional herbal medical product licensed by the Ministry of Health, dosing of which is stated in writing in compliance with the clinical studies has been officialised by obtaining the approval of health authorities and presented to the service of world medicine.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Botany (AREA)
  • Obesity (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Biotechnology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Dans l'industrie pharmaceutique, l'invention concerne l'utilisation d'une préparation à base de plantes, contenant de l'huile de lin riche en acide linolénique (ALA), qui est un acide gras oméga 3 de plante, dans le traitement de régulation des taux de lipies dans le sang. Ladite préparation à base de plantes comprend de l'huile de lin, du di-α-tocophérol, du di-α-tocophéryl acétate, de la glycérine, de l'eau purifiée et de la gélatine maintenant l'intégrité et la formation du contenu.
PCT/TR2018/050092 2017-03-10 2018-03-09 Utilisation d'une préparation à base de plantes, contenant de l'huile de lin, dans le traitement de régulation des taux de lipides (graisse) dans le sang WO2018222166A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR201703735 2017-03-10
TR2017/03735 2017-03-10

Publications (3)

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WO2018222166A2 true WO2018222166A2 (fr) 2018-12-06
WO2018222166A3 WO2018222166A3 (fr) 2019-01-10
WO2018222166A9 WO2018222166A9 (fr) 2019-04-11

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PCT/TR2018/050092 WO2018222166A2 (fr) 2017-03-10 2018-03-09 Utilisation d'une préparation à base de plantes, contenant de l'huile de lin, dans le traitement de régulation des taux de lipides (graisse) dans le sang

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104288345B (zh) * 2013-07-15 2018-08-24 湘北威尔曼制药股份有限公司 一种辅助降血脂的中药组合物及其制备方法

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WO2018222166A3 (fr) 2019-01-10

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