WO2023017533A1 - A nutritional capsule of ayurvedic herbs, unani herbs, minerals, amino acids, vitamins, probiotic and nutraceuticals - Google Patents

A nutritional capsule of ayurvedic herbs, unani herbs, minerals, amino acids, vitamins, probiotic and nutraceuticals Download PDF

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Publication number
WO2023017533A1
WO2023017533A1 PCT/IN2022/050713 IN2022050713W WO2023017533A1 WO 2023017533 A1 WO2023017533 A1 WO 2023017533A1 IN 2022050713 W IN2022050713 W IN 2022050713W WO 2023017533 A1 WO2023017533 A1 WO 2023017533A1
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vitamin
herbs
benefits
ingredients
beta
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PCT/IN2022/050713
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French (fr)
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I. Tak ASIF
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Auffullen Healthcare Pvt. Ltd.
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    • 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)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • A—HUMAN NECESSITIES
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    • 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
    • A61K31/07—Retinol compounds, e.g. vitamin A
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
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    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
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    • 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
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    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4188—1,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
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    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
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    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525—Isoalloxazines, e.g. riboflavins, vitamin B2
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    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/592—9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
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Definitions

  • the present invention relates to nutritional capsules for men and women having ayurvedic herbs, Unani Herbs, Minerals, amino acids, vitamins and nutraceuticals.
  • Nutritional supplements are primarily important for those who have inadequate diets reduced ability to utilize or absorb vitamins and minerals from food.
  • the conventional nutritional products are having some negative effects due to its ingredients.
  • the object of this invention is to provide a capsule which reduces a multistep morning ritual into a single convenient dose form. It is further an object of this invention to provide vitamin I and mineral supplements which when taken, help to establish consistent use of the supplements.
  • the present invention is a nutritional capsule having Ayurvedic herbs, Unani Herbs, minerals, amino acids, vitamins and nutraceuticals which reduces negative effects of some ingredients.
  • This invention is related to Ayurvedic, Unani, herbal and nutraceutical preparation which is a nutrition for men and women.
  • This preparation is a unique blend of 9 different Ayurvedic herbs, 4 different Unani herbs, 13 minerals, 11 essential amino acids, 13 vitamins and 17 nutraceuticals. These ingredients are obtained in powder form and mixed to obtain this exclusive capsule for men and women separately. This capsule taste neutral and odor masked capsule. Also, these capsules are used to replete the nutrition for men and women. The quantities which are added in these capsules are as per the RDA norms. It is formulated by taking nutritional values that is required by the body of men and women. The invention provides necessary nutrition in humans which they do not get from the meals that they consume. It gives benefits to the whole body for example improving immune system, digestion, good for skin, hair, bones and many more. The exceptionality of the invention is that one capsule of the invention per day is more than enough. The invention can help achieve a good healthy body.
  • the invention contains the following ingredients:- 7.
  • Emblica officinalis Parts used Fruit Major Phytochemical constituents: Emblicanin A and B, Pedunculagin, Phyllembein, Ellagic acid, Kaempferol [3] .
  • Jathikka Scientific name Myristica fragrans Parts used: Fruit Major Phytochemical constituents: Lignans and neolignans, ferulic acid, catechins, caffeic acid, epicatechins, protocatechuic acids [4] .
  • Pomegranate shows potential activity against heart related diseases, almost all types of cancers, diabetes, aging, bacterial infections [5] . 5.
  • Trigonella foenum-graecum is used to ease child birth and to increase milk flow. Also, it is used to relieve menstrual cramps and abdominal pain [7] .
  • Bilberry Scientific name Vaccinium mytrillus Parts used: fruit Major Phytochemical constituents: Anthocyanins, Delphinidins, Cyanidins, Petunidins, Malvidins, Peonidins [8] .
  • Benefits: Satawar is well known for to prevent aging and to increase longevity. Satawar also improves mental functions [9] .
  • Salab misri used in the treatment of sexually transmitted diseases such as Syphilis, diarrhea, Pain related to bladder, Partial paralysis, indigestion, tuberculosis, weakness and parasitic infection [10] .
  • Benefits: Tribulus terrestris is used as hypertensive and urinary disinfectant. Tribulus terrestris can also be good for reducing the level of serum glucose and serum cholesterol. Tribulus terrestris also improves the function of heart [11] .
  • Habbal sawda Scientific name Nigella Sativa Parts used: Seeds Major Phytochemical constituents: Alkaloids, Saponins, Essential oils, Nigellisimine, Nigellidine, Nigellicine, Thymoquinone, d-limonene [13] .
  • Nigella Sativa seeds have effects such as antioxidant, gastroprotective, anti- anxiety, anti-ulcer, antiasthmatic, anti-cancer, anti-inflammatory, and anti-tumor properties and liver protective.
  • Nigella Sativa shows improvement in men infertility, stimulation in milk production. It also shows improvement in immunity related disorders, memory and cardiovascular diseases [13] .
  • Khadir Scientific name Acacia Arabica or Acacia nilotica Parts used: pods Major Phytochemical constituents: Tannin, dicatechin, quercetin, gallic acid and alpha- amyrin, ß-sitosterol [14] .
  • the pods of Acacia Arabica are used for impotency, urino-genital disorder and in dry cough.
  • the fresh pods of Acacia Arabica tree are effective in treating sexual disorders such as spermatorrhoea, loss of consistency of semen, frequent night discharges and premature ejaculation [15] .
  • Nutraceuticals 1. Green tea extract Scientific name: Camellia sinensis Parts used: Leaves Major Phytochemical constituents: Linoleic acid, catechin, Stigmasterols, Carotenoids, Volatile compounds, Alkaloids, Theobromine, Phenolic acids [16] .
  • Camellia sinensis shows positive health benefits, including the prevention of cancer and cardiovascular diseases, antiarthritic, antibacterial, antioxidative, antiviral, neuroprotective and cholesterol-lowering effects [16] .
  • Ginseng extract Scientific name: Panax ginseng Parts used: Roots Major Phytochemical constituents: ginsenosides, triterpene saponins, fatty acids, phenolic compounds, essential oils, polyacetylenes [18] .
  • Lutein IUPAC Name: (1R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(1R,4R)-4-hydroxy- 2,6,6-trimethylcyclohex-2-en-1-yl]-3,7,12,16-tetramethyloctadeca- 1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-ol Benefits: Lutein may prevent age-related diseases, including cataract, heart disease, and some forms of cancer [19] . 5.
  • Zeaxanthin IUPAC Name: (1R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(4R)-4-hydroxy- 2,6,6-trimethylcyclohexen-1-yl]-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17- nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-ol Benefits: Zeaxanthin may prevent against several age-related diseases, including cataract, heart disease, and some forms of cancer [19] . 6.
  • Colostrum Benefits Colostrum is used to treat joint related problems, whereas it is also used to prevent immunity related disorders, it also has antibacterial and antiviral activity [21] . 8.
  • Citrus bioflavonoid Benefits Citrus Flavonoids shows positive effects on the treatment of dyslipidemia, insulin resistance, hepatic steatosis, obesity and atherosclerosis [22] .
  • Insulin is a double-chain protein hormone that is formed from proinsulin in the beta cells of the pancreatic islets of Langerhans. Insulin is secreted into the blood in response to a rise in concentration of glucose in the blood. Insulin promotes the storage of glucose in the liver, skeletal muscle and adipose tissue, and is necessary for the body to be able to use sugar, which is the basic fuel for cells in the body. Insulin is necessary for the body to be able to use glucose that enters into the bloodstream after eating. It transports the sugar from the bloodstream into cells, and acts as a messenger to inform the liver of the quantity of sugar that should be released into the bloodstream.
  • diabetes hyperglycemia
  • Insulin and other diabetes medications are often administered to diabetic or other glucose intolerant humans by injection, or through use of an insulin pump, in order to lower blood glucose levels.
  • Glucose Intolerance and Diabetes Several distinct disorders of glucose tolerance presently exist. The most widely used classification of diabetes mellitus and other categories of glucose intolerance is that recommended by the World Health Organization (WHO) in 1985.
  • diabetes mellitus (“diabetes”) is a medical disorder that is characterized by varying or persistent hyperglycemia (elevated blood sugar levels), especially after eating. Hypoglycemia (low blood sugar) is rarely a feature of diabetes, except as an accident of treatment (usually a misapplication of medication in particular circumstances).
  • Inflammation and excessive weight are each imp;ortant risk factors that may cuase a transformation of pre-diabetic, or borderlin, diabetic condition into diabetes. Inflammation is also believed to cause complications that are associated with diabetes, such as eye and kidney disease..
  • MSM Scientific name Methylsulfonylmethane Benefits: MSM is well tolerated for arthritis and a number of other conditions related to inflammation, physical function, and performance. Emerging research suggests that MSM may one day aid in the treatment of various types of cancer [24] . 11.
  • Coenzyme Q10 supplements alone or in combination with other drug therapies and nutritional supplements may help prevent or treat some of the following conditions: cardiovascular diseases, high blood pressure, cancer, periodontal diseases, mitochondrial disorders, radiation injury, obesity, diabetes, Parkinson's disease, acquired immune deficiency syndrome (AIDS), gastric ulcers, allergy, migraine headaches, kidney failure, muscular dystrophy, and aging [26] .
  • Astaxanthin IUPAC Name: (6S)-6-Hydroxy-3-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(4S)-4- hydroxy-2,6,6-trimethyl-3-oxo-1-cyclohexenyl]-3,7,12,16-tetramethyloctadeca- 1,3,5,7,9,11,13,15,17-nonaenyl]-2,4,4-trimethyl-1-cyclohex-2-enone
  • Astaxanthin has shown potential pharmacological effects against cancer, diabetes, brain related problems, heart related problems, eye and skin related problems [27] . 14.
  • Lactobacillus acidophilus is very well known probiotic; it helps to maintain intestinal microbial balance [28] .
  • Rose hip extract Scientific name Rosa canina Parts used: Flowers (Petals) Major Phytochemical constituents: phenols, ascorbic acid, tocopherols, ⁇ -carotene, lycopene, tannins, pectin [31] .
  • Calcium Source Calcium citrate malate Molecular formula of sources: (C6H7O7)x ⁇ (C4H5O5)y ⁇ (Ca2+)z Calcium present in source: 21 % [33] Benefits: Calcium helps to reduce blood pressure, reduces possibilities of kidney stones and promotes weight loss [34] .
  • Potassium Source Potassium Iodide Molecular formula of sources: KI Potassium present in source: 23.55 % Benefits: Potassium helps to reduce the risk of cardiovascular disease and stroke. Potassium also protects against bone loss [35] . 3.
  • Magnesium Source Magnesium sulphate Molecular formula of sources: MgSO 4 Magnesium present in source: 20.1925 % Benefits: Magnesium has several functions in the human body. It acts as a cofactor for more than 300 enzymes, which regulates the number of fundamental functions such as muscle contraction, neuromuscular conduction, myocardial contraction, controlling diabetes and blood pressure [36] . 4.
  • Manganese Source Manganese sulphate Molecular formula of sources: M n SO 4 Manganese present in source: 36.38 % Benefits: Manganese is an essential nutrient required for the formation of bone and also required to regulate amino acid, cholesterol, and carbohydrate metabolism [37] . 5.
  • Zinc Source Zinc sulphate monohydrate Molecular formula of sources: ZnSO4.H2O Zinc present in source: 36.43 % Benefits: Zinc deficiency results into immune related disorders, diarrhea and altered cognition etc. [37] . 6.
  • Iron Source Ferrous Fumarate Molecular formula of sources: CuSO4 Iron present in source: 32.86 % Benefits: Iron is required to develop healthy red blood cells which are also known as hemoglobin. Insufficient iron in the body results into Anemia [37] .
  • Copper Source Copper sulphate Molecular formula of sources: CuSO4 Copper present in source: 39.81 % Benefits: Copper is needed for maintaining proper cholesterol level [38] . 8.
  • Chromium Source Chromium Picolinate Molecular formula of sources: Cr(C 6 H 4 NO 2 ) 3 Chromium present in source: 12.43 % Benefits: Chromium has been shown to play an important role in type 2 diabetes mellitus, gestational diabetes, steroid-induced diabetes and glucose intolerance by providing significant beneficial effects of the insulin system, often enhancing insulin sensitivity and overcoming glucose intolerance [39] . 9. Boron Source: Boron citrate Molecular formula of sources: C 6 H 5 BO 7 Boron present in source: 5.40 % Benefits: Boron prevents bone related problems, central nervous system related problems and cancer. It maintains hormonal balance and immunity within the body [ 40] . 10.
  • Iodine Source Potassium Iodide Molecular formula of sources: KI Iodine present in source: 76.45 % Benefits: An inadequate dietary intake of iodine leads to insufficient production of thyroid hormones, which affects many parts of the body, particularly muscle, heart, liver, kidney and the developing brain [41] . 11.
  • Phosphorous Source Di calcium phosphate IP Molecular formula of source: CaHPO4 Phosphorous present in source: 22.76 % Benefits: Phosphate is one of the most important molecular elements to normal cellular functions within the body. It acts as an integral component of nucleic acids and also it is used to replicate DNA and RNA [42] . 12.
  • Molybdenum Source Sodium molybdate Molecular formula of sources: Na 2 MoO 4 Molybdenum present in source: 46.59 % Benefits: Molybdenum deficiency causes rapid heart rate, night blindness and headache [42] . 13.
  • Selenium Source Selenomethionine Molecular formula of source: C 5 H 11 NO 2 Se Selenium present in source: 40.26 % Benefits: Supplementation of selenium may improve atherosclerosis, hypercholesterolemia, type 1 diabetes mellitus [43] . Vitamins:- 1.
  • Vitamin C Molecular formula: C 6 H 8 O 6 IUPAC name: (2R)-2-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxy-2H-furan-5-one Chemical structure: Benefits: Vitamin C is essential to prevent scurvy in humans. It is used as the primary prevention of common and complex diseases such as coronary heart disease, stroke, and cancer [44] . 2.
  • Vitamin E Molecular formula: C 29 H 50 O 2 IUPAC name: (2R)-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4- dihydrochromen-6-ol Chemical structure: Benefits: Vitamin E has been found to be very effective in the prevention and reversal of various disease complications due to its function as an antioxidant, its role in anti- inflammatory processes, its inhibition of blood clots and its immune-enhancing activity. Vitamin E also possesses anti-cancer properties [45] . 3.
  • Vitamin A Molecular formula: C 20 H 30 O IUPAC name: (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona- 2,4,6,8-tetraen-1-ol
  • Benefits Vitamin A's involvement in cell morphogenesis, differentiation, and proliferation is essential to gene regulation. Additionally, its function as an antioxidant decreases free radical damage to DNA. A deficiency in vitamin A is believed to play a role in tumor formation and cancerous cells. [46] . 4.
  • Folic acid Molecular formula: C 19 H 19 N 7 O 6 IUPAC name: (2S)-2-[[4-[(2-amino-4-oxo-3H-pteridin-6- yl)methylamino]benzoyl]amino]pentanedioic acid Chemical structure: Benefits: Folate is necessary for the production and maintenance of new cells, for DNA synthesis and RNA synthesis through methylation, and for preventing changes to DNA [47] . 5.
  • Vitamin K2-7 Molecular formula: C 31 H 46 O 2 IUPAC name: 2-methyl-3-[(E)-3,7,11,15-tetramethylhexadec-2-enyl]naphthalene-1,4- dione Chemical structure: Benefits: Vitamin K2-7 has a plethora of potential implications, including prevention and treatment of arterial calcifications, coronary heart disease and cancer. It also improves bone strength and reduces risks of fractures. Vitamin K2-7 has shown improvements in insulin sensitivity [48] . 6.
  • Vitamin D Molecular formula: C27H44O IUPAC name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2- yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4- methylidenecyclohexan-1-ol Chemical structure: Benefits: Poor vitamin D intake and low blood levels of vitamin D metabolites are associated with increased incidence and severity of several autoimmune diseases involving the T helper type 1 lymphocyte, including multiple sclerosis, rheumatoid arthritis, type I diabetes, systemic lupus erythematosus, and psoriasis.
  • T helper type 1 lymphocyte including multiple sclerosis, rheumatoid arthritis, type I diabetes, systemic lupus erythematosus, and psoriasis
  • Biotin Molecular formula C 10 H 16 N 2 O 3 S IUPAC name: 5-[(3aS,4S,6aR)-2-oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol- 4-yl]pentanoic acid Chemical structure: Benefits: This vitamin, Biotin is involved in the regulation of fatty acid synthesis and it also influences the carbohydrate metabolism. More recently, the role of biotin in the regulation of gene expression has also been established [51] . 9.
  • Vitamin B3 Molecular formula: C6H5NO2 IUPAC name: pyridine-3-carboxylic acid Chemical structure: Benefits: Vitamin B3, also known as Niacin possesses anti-oxidative and anti- inflammatory activities. These activities decrease the risk of cardiovascular disease [ 52] . 10. Vitamin B5 Molecular formula: C 9 H 17 NO 5 IUPAC name: 3-[[(2R)-2,4-dihydroxy-3,3-dimethylbutanoyl]amino]propanoic acid Chemical structure: Benefits: Vitamin B5 has been shown to reduce many signs of skin aging, including hyper pigmentation and redness [53] . Vitamin B5 improves the texture of skin giving shiny and healthy looking skin. 11.
  • Vitamin B2 Molecular formula: C17H20N4O6 IUPAC name: 7,8-dimethyl-10-[(2S,3S,4R)-2,3,4,5- tetrahydroxypentyl]benzo[g]pteridine-2,4-dione Chemical structure: Benefits: Vitamin B2 also known as, Riboflavin is a water-soluble and heat-stable vitamin that the body uses to metabolize fats, protein, and carbohydrates into glucose for energy. Riboflavin is used as an antioxidant for proper function of the immune system, healthy skin and hair. This is done with the help of two main coenzymes, flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD).
  • FMN flavin mononucleotide
  • FAD flavin adenine dinucleotide
  • Vitamin B1 Molecular formula: C12H17ClN4OS IUPAC name: 2-[3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol- 3-ium-5-yl]ethanol;chloride Chemical structure: Benefits: Wernicke-Korsakoff syndrome (WKS) and Beriberi are the two most common complications that may arise from a thiamin or vitamin B1 deficiency, though these two syndromes rarely occur at same time in an individual. WKS affects the central nervous system, which involves the brain and spinal cord.
  • Beriberi is another disorder caused by a thiamin or vitamin B1 deficiency.
  • symptoms of beriberi include constipation, appetite suppression, nausea, mental depression, fatigue, peripheral neuropathy, anorexia, and weight loss. With progression, chronic symptoms can begin to manifest as either wet beriberi or dry beriberi. Wet beriberi presents with edema, an enlarged heart, cardiac failure etc [55] . 13.
  • Vitamin B6 Molecular formula: C 8 H 11 NO 3 IUPAC name: 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol Chemical structure: Benefits: Vitamin B6 is an interesting micronutrient that mediates numerous metabolic processes in vivo including amino acid metabolism, gluconeogenesis, lipid metabolism, and nervous system development and functioning. Vitamin B6 has been implicated in the regulation of immune responses that are associated with a wide range of diseases, including inflammation and various cancers [56] . Amino acids: 1.
  • Arginine may prevent or treat heart and circulatory diseases, combat fatigue, and stimulate the immune system. It also boosts production of nitric oxide, relaxing blood vessels and treating angina and other cardiovascular problems [58] .
  • L-Methionine Chemical formula: C 5 H 11 NO 2 S IUPAC name: (2S)-2-amino-4-methylsulfanylbutanoic acid Chemical structure: Benefits: Methionine is one of nine essential amino acids in humans (provided by food), Methionine is required for growth and tissue repair. A sulphur-containing amino acid, methionine improves the tone and pliability of skin, hair, and strengthens nails [59] . 4.
  • L-Phenylalanine Chemical formula: C 9 H 11 NO 2 IUPAC name: (2S)-2-amino-3-phenylpropanoic acid Chemical structure: Benefits: Phenylalanine Used by the brain to produce Norepinephrine, a chemical that transmits signals between nerve cells and the brain; keeps you awake and alert; reduces hunger pains; functions as an antidepressant and helps improve memory [60] . 5.
  • Carnitine deficiency is not as rare and is most commonly associated with dialysis in chronic renal failure, although it can also be induced by intestinal resection, severe infection, and liver disease. Other conditions associated with a carnitine deficiency include cancer, diabetes, Alzheimer's disease, and heart failure [62] . 7.
  • Histidine is important for maintenance of myelin sheaths that protect nerve cells and is metabolized to the neurot ransmitter histamine. Histamines play many roles in immunity, gastric secretion, and sexual functions. Histidine is also required for blood cell manufacture and protects tissues against damage caused by radiation and heavy metals [64] .
  • L-Leucine Chemical formula: C 6 H 13 NO 2 IUPAC name: (2S)-2-amino-4-methylpentanoic acid Chemical structure: Benefits: An essential amino acid. Leucine helps with the regulation of blood-sugar levels, the growth and repair of muscle tissue (such as bones, skin and muscles), growth hormone production, and wound healing as well as energy regulation [65] . 10.
  • L-Isoleucine Chemical formula: C6H13NO2 IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid Chemical structure: Benefits: L-Isoleucine is one of nine essential amino acids in humans (present in dietary proteins), L-Isoleucine has diver se physiological functions, such as assisting wound healing, detoxification of nitrogenous wastes, stimulating immune function, and promoting secretion of several hormones. Necessary for hemoglobin formation and regulating blood sugar and energy levels, L-Isoleucine is concentrated in muscle tissues in humans [66] . 11.
  • L-Threonine Chemical formula: C4H9NO3 IUPAC name: (2S,3R)-2-amino-3-hydroxybutanoic acid Chemical structure: Benefits: L-Threonine is an essential amino acid that helps to maintain the proper protein balance in the body. It is important for the formation of collagen, elastin, and tooth enamel [67] . 10 ) Manufacturing Technology: Technologies which are used while preparing these capsules are: (a) Phyto-Alkatech – This technology is used to neutralize acidic ingredients and to reduce gastric irritation. It also enhances absorption of all ingredients. (b) Syner-Tech — This technology is used to make sure better working of all the ingredients present. This technology also increases beneficial effects of multiple ingredients.
  • Raw materials are weighed as per the batch size. These materials are then added to the vessel of drum mixer for mixing, which is made up of stainless steel. Mixing is done for duration of 30 minutes. All the powdered raw materials are added altogether. Liquid materials were sprayed on powdered raw material in regular intervals during mixing. As all the raw materials are heat sensitive, the temperature has been maintained at 25 0 C throughout the mixing. Also, humidity level was retained under 40% RH to avoid any condensation.
  • Capsule or pouch filing Capsules are first checked for any tempering and consistent weight. At first few of the capsules are checked, if the filling machine delivers the stated amount of filling. Once satisfied, filling is done for the whole batch using Hand Operated Capsule Filling Machine.

Abstract

A nutritional capsule for men and women having Ayurvedic Herbs, Unani Herbs, minerals, amino acids, vitamins, probiotics and nutraceuticals is made by using the technology to neutralize acidic ingredients and to reduce gastric irritation and to provide absorption of all ingredients. The technology is used to make sure better working of all ingredients present and to increase beneficial effect of multiple ingredients. The technology reduces side effects of some ingredients. The preparation contains 9 types of ayurvedic Herbs, 4 types of unani herbs, 13 minerals, 11 essential amino acids, 13 vitamins and 17 nutraceuticals.

Description

A NUTRITIONAL CAPSULE OF AYURVEDIC HERBS, UNANI HERBS, MINERALS, AMINO ACIDS, VITAMINS, PROBIOTIC AND NUTRACEUTICALS
BACKGROUND OF THE INVENTION :
The present invention relates to nutritional capsules for men and women having ayurvedic herbs, Unani Herbs, Minerals, amino acids, vitamins and nutraceuticals.
1. Nutrient intake surveys have shown world’s population consumes substantially less than the recommended amounts of numerous vitamins and minerals.
2. Nutritional supplements are primarily important for those who have inadequate diets reduced ability to utilize or absorb vitamins and minerals from food.
The conventional nutritional products are having some negative effects due to its ingredients.
OBJECT OF THE PRESENT INVENTION:
3. The object of this invention is to provide a capsule which reduces a multistep morning ritual into a single convenient dose form. It is further an object of this invention to provide vitamin I and mineral supplements which when taken, help to establish consistent use of the supplements.
4. It also the object of the present invention is to avoid the side effects of certain ingredients.
BRIEFT SUMMARY OF THE INVENTION :
The present invention is a nutritional capsule having Ayurvedic herbs, Unani Herbs, minerals, amino acids, vitamins and nutraceuticals which reduces negative effects of some ingredients.
TECHNICAL DETAILS OF THE INVENTION: This invention is related to Ayurvedic, Unani, herbal and nutraceutical preparation which is a nutrition for men and women. This preparation is a unique blend of 9 different Ayurvedic herbs, 4 different Unani herbs, 13 minerals, 11 essential amino acids, 13 vitamins and 17 nutraceuticals. These ingredients are obtained in powder form and mixed to obtain this exclusive capsule for men and women separately. This capsule taste neutral and odor masked capsule. Also, these capsules are used to replete the nutrition for men and women. The quantities which are added in these capsules are as per the RDA norms. It is formulated by taking nutritional values that is required by the body of men and women. The invention provides necessary nutrition in humans which they do not get from the meals that they consume. It gives benefits to the whole body for example improving immune system, digestion, good for skin, hair, bones and many more. The exceptionality of the invention is that one capsule of the invention per day is more than enough. The invention can help achieve a good healthy body.
6) The invention contains the following ingredients:-
Figure imgf000004_0001
Figure imgf000005_0001
7. The details of Ingredients of Ayurvedic Herbs:- 1. Muringa Scientific name: Moringa oleifera Parts used: Drumstick (fruit) Major Phytochemical constituents: Isothiocyanate, nitrites, thiocarbamates,O- (1heptenyloxy) propyl undecanoate, O-ethyl-4-(alpha-L-rhamnosyloxy) benzyl carbamate, methyl- p-hydroxybenzoate, beta- sitosterol [1]. Benefits: The bioactive components present in Moringa oleifera are known to treat diarrhea, liver and spleen problems. It is used to treat joint pain [2]. 2. Amalaki Scientific name: Emblica officinalis Parts used: Fruit Major Phytochemical constituents: Emblicanin A and B, Pedunculagin, Phyllembein, Ellagic acid, Kaempferol [3]. Benefits: The bioactive components present in Emblica officinalis are known to regulate blood sugar and cholesterol level. Emblica officinalis also helps to improve intelligence and memory power [3]. 3. Jathikka Scientific name: Myristica fragrans Parts used: Fruit Major Phytochemical constituents: Lignans and neolignans, ferulic acid, catechins, caffeic acid, epicatechins, protocatechuic acids [4]. Benefits: Myristica fragrans is used as a remedy for stomach and kidney disorders. There are also reports on the traditional uses for skin infections [4]. 4. Pomegranate Scientific name: Punica granatum Parts used: Fruit Major Phytochemical constituents: Punicalgin, Punicalin, Polyphenols, Elagitannins, Anthocyanins, Gallotannins [5]. Benefits: Pomegranate shows potential activity against heart related diseases, almost all types of cancers, diabetes, aging, bacterial infections [5]. 5. Olive Scientific name: Olea Europea Parts used: fruit Major Phytochemical constituents: Oleuropein, Olivil, Esculin, Scopolin, Wedelosin, Hellicoside, Uvaol, Berchemol, Verucosin [6]. Benefits: Olives are known for maintaining blood sugar, cholesterol and uric acid level. Also, it has been used to treat respiratory and urinary tract infections, asthma, hemorrhoids, stomach and intestinal diseases [6]. 6. Medhika Scientific name: Trigonella foenum-graecum Parts used: Seed Major Phytochemical constituents: Fenugrin B, Fenugreekine, Trigofoenosides A-G, tigogenin, neotigogenin [7]. Benefits: Trigonella foenum-graecum is used to ease child birth and to increase milk flow. Also, it is used to relieve menstrual cramps and abdominal pain [7]. 7. Bilberry Scientific name: Vaccinium mytrillus Parts used: fruit Major Phytochemical constituents: Anthocyanins, Delphinidins, Cyanidins, Petunidins, Malvidins, Peonidins [8]. Benefits: Bilberries are known to improve vision. They also control the blood sugar level and maintain the cholesterol level [8]. 8. Satawar Scientific name: Asparagus racemosus Parts used: Roots Major Phytochemical constituents: Shatavarin I, Aspargamine A, Racemosol, Racemofuran, Kaepfrol, Sarsapogenin [9]. Benefits: Satawar is well known for to prevent aging and to increase longevity. Satawar also improves mental functions [9]. 9. Salabmisri Scientific name: Orchis latifolia Linn. Parts used: Seeds Major Phytochemical constituents: phenolic acids, tannin, flavanoids, coumarins and terpenoids [10]. Benefits: Salab misri used in the treatment of sexually transmitted diseases such as Syphilis, diarrhea, Pain related to bladder, Partial paralysis, indigestion, tuberculosis, weakness and parasitic infection [10]. Unani herbs:- 1. Hasak Scientific name: Tribulus terrestris Parts used: Fruit Major Phytochemical constituents: Saponins, Flavonoids, Tannins, Tribuloside, Terrestribisamide, Tribulusterine, Stigmasterols [11]. Benefits: Tribulus terrestris is used as hypertensive and urinary disinfectant. Tribulus terrestris can also be good for reducing the level of serum glucose and serum cholesterol. Tribulus terrestris also improves the function of heart [11]. 2. Guduchi Scientific name: Tinospora cordifolia Parts used: Stem Major Phytochemical constituents: Diterpenoids, Bergenin, Syringen, Gilenin, Columbin, Gilosterol, Palmatoside F [12]. Benefits: Tinospora cordifolia is used to reduce body heat for example in a case of Jaundice. It is also used for indigestion, weakness, fever and urinary diseases [12]. 3. Habbal sawda Scientific name: Nigella Sativa Parts used: Seeds Major Phytochemical constituents: Alkaloids, Saponins, Essential oils, Nigellisimine, Nigellidine, Nigellicine, Thymoquinone, d-limonene [13]. Benefits: Nigella Sativa seeds have effects such as antioxidant, gastroprotective, anti- anxiety, anti-ulcer, antiasthmatic, anti-cancer, anti-inflammatory, and anti-tumor properties and liver protective. Nigella Sativa shows improvement in men infertility, stimulation in milk production. It also shows improvement in immunity related disorders, memory and cardiovascular diseases [13]. 4. Khadir Scientific name: Acacia Arabica or Acacia nilotica Parts used: pods Major Phytochemical constituents: Tannin, dicatechin, quercetin, gallic acid and alpha- amyrin, ß-sitosterol [14]. Benefits: The pods of Acacia Arabica are used for impotency, urino-genital disorder and in dry cough. The fresh pods of Acacia Arabica tree are effective in treating sexual disorders such as spermatorrhoea, loss of consistency of semen, frequent night discharges and premature ejaculation [15]. Nutraceuticals 1. Green tea extract Scientific name: Camellia sinensis Parts used: Leaves Major Phytochemical constituents: Linoleic acid, catechin, Stigmasterols, Carotenoids, Volatile compounds, Alkaloids, Theobromine, Phenolic acids [16]. Benefits: Camellia sinensis shows positive health benefits, including the prevention of cancer and cardiovascular diseases, antiarthritic, antibacterial, antioxidative, antiviral, neuroprotective and cholesterol-lowering effects [16]. 2. Grape seed extract Scientific name: Vitis vinifera Parts used: Seeds Major Phytochemical constituents: Proanthocyanidin, Polyphenolic compounds, Epicatechin, gallic acid, Viniferones A, B and C [17]. Benefits: Phytochemical compounds present in the seeds of Vitis vinifera protect the body from sun damage, improve vision, and improve blood circulation [17]. 3. Ginseng extract Scientific name: Panax ginseng Parts used: Roots Major Phytochemical constituents: ginsenosides, triterpene saponins, fatty acids, phenolic compounds, essential oils, polyacetylenes [18]. Benefits: Panax ginseng is effective on headache, fatigue, diabetes, dizziness, nausea, asthma, Alzheimer’s disease, hemorrhage and impotence, increase physical stamina and mental capacity, to improve resistance against diseases and work efficiency and to prevent muscle damage from exercise and athletic endurance [18]. 4. Lutein IUPAC Name: (1R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(1R,4R)-4-hydroxy- 2,6,6-trimethylcyclohex-2-en-1-yl]-3,7,12,16-tetramethyloctadeca- 1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-ol Benefits: Lutein may prevent age-related diseases, including cataract, heart disease, and some forms of cancer [19]. 5. Zeaxanthin IUPAC Name: (1R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(4R)-4-hydroxy- 2,6,6-trimethylcyclohexen-1-yl]-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17- nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-ol Benefits: Zeaxanthin may prevent against several age-related diseases, including cataract, heart disease, and some forms of cancer [19]. 6. Lycopene IUPAC Name: (6E,8E,10E,12E,14E,16E,18E,20E,22E,24E,26E)- 2,6,10,14,19,23,27,31-octamethyldotriaconta-2,6,8,10,12,14,16,18,20,22,24,26,30- tridecaene Benefits: Lycopene have been studied for their activity against cardiovascular disease, hypertension, atherosclerosis, cancers and diabetes [20]. 7. Colostrum Benefits: Colostrum is used to treat joint related problems, whereas it is also used to prevent immunity related disorders, it also has antibacterial and antiviral activity [21]. 8. Citrus bioflavonoid Benefits: Citrus Flavonoids shows positive effects on the treatment of dyslipidemia, insulin resistance, hepatic steatosis, obesity and atherosclerosis [22]. 9. Inulin IUPAC Name: alpha-D-gluco-hexopyranosyl beta-D-arabino-hex-2-ulofuranosyl-(2- >1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl- (2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2- ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex- 2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino- hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D- arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta- D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)- beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2- >1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl- (2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2- ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex- 2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino- hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D- arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta- D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)- beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2- >1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl- (2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex-2- ulofuranosyl-(2->1)-beta-D-arabino-hex-2-ulofuranosyl-(2->1)-beta-D-arabino-hex- 2-ulofuranoside studies showed that Inulin is used as bifidogenic agents that increases Bifidobacteria in the product or in intestines, stimulating the immune system of the body, decreasing the levels of pathogenic bacteria in the intestine, relieving constipation, decreasing the risk of osteoporosis by increasing mineral absorption, especially of calcium, reducing the risk of atherosclerosis by lowering the synthesis of triglycerides and fatty acids in the liver and decreasing their level in serum. a) Insulin is a double-chain protein hormone that is formed from proinsulin in the beta cells of the pancreatic islets of Langerhans. Insulin is secreted into the blood in response to a rise in concentration of glucose in the blood. Insulin promotes the storage of glucose in the liver, skeletal muscle and adipose tissue, and is necessary for the body to be able to use sugar, which is the basic fuel for cells in the body. Insulin is necessary for the body to be able to use glucose that enters into the bloodstream after eating. It transports the sugar from the bloodstream into cells, and acts as a messenger to inform the liver of the quantity of sugar that should be released into the bloodstream. If the body produces too much insulin, blood sugar levels fall, resulting in typical symptoms of fainting and/or convulsions (hypoglycemia). An elevated blood sugar level, on the other hand, can be attributable to a reduced insulin formation, as occurs in diabetes (hyperglycemia). Insulin and other diabetes medications are often administered to diabetic or other glucose intolerant humans by injection, or through use of an insulin pump, in order to lower blood glucose levels. Glucose Intolerance and Diabetes. Several distinct disorders of glucose tolerance presently exist. The most widely used classification of diabetes mellitus and other categories of glucose intolerance is that recommended by the World Health Organization (WHO) in 1985. Recently, the American Diabetes Association (ADA) proposed a system based upon disease etiology instead of classification according to type of pharmacological treatment. The major categories of the disorders of glucose tolerance (glycemia) are type 1 diabetes mellitus, type 2 diabetes mellitus, other specific types of diabetes, gestational diabetes mellitus (GDM), impaired glucose tolerance (IGT) and impaired fasting glucose (IFG). Diabetes mellitus (“diabetes”) is a medical disorder that is characterized by varying or persistent hyperglycemia (elevated blood sugar levels), especially after eating. Hypoglycemia (low blood sugar) is rarely a feature of diabetes, except as an accident of treatment (usually a misapplication of medication in particular circumstances). Although different types of diabetes exist, most are asymptomatic for a variable time after onset, and all types generally share similar symptomatology and complications at advanced stages Inflammation and excessive weight (above-normal body weight) are each imp;ortant risk factors that may cuase a transformation of pre-diabetic, or borderlin, diabetic condition into diabetes. Inflammation is also believed to cause complications that are associated with diabetes, such as eye and kidney disease..
10. MSM Scientific name: Methylsulfonylmethane Benefits: MSM is well tolerated for arthritis and a number of other conditions related to inflammation, physical function, and performance. Emerging research suggests that MSM may one day aid in the treatment of various types of cancer [24]. 11. Omega-3 fatty acid IUPAC Name: (4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid;(5E,8E,11E,14E,17E)-henicosa-5,8,11,14,17-pentaenoic acid Benefits: Evidence suggests that omega−3 fatty acids modestly lower blood Pressure (systolic and diastolic) in people with hypertension and in people with normal blood pressure [25]. 12. CoEnzyme Q10 IUPAC Name: 2-[(2E,6E,10E,14E,18E,22E,26E,30E,34E)- 3,7,11,15,19,23,27,31,35,39-Decamethyltetraconta-2,6,10,14,18,22,26,30,34,38- decaenyl]-5,6-dimethoxy-3-methylcyclohexa-2,5-diene-1,4-dione Benefits: Coenzyme Q10 supplements alone or in combination with other drug therapies and nutritional supplements may help prevent or treat some of the following conditions: cardiovascular diseases, high blood pressure, cancer, periodontal diseases, mitochondrial disorders, radiation injury, obesity, diabetes, Parkinson's disease, acquired immune deficiency syndrome (AIDS), gastric ulcers, allergy, migraine headaches, kidney failure, muscular dystrophy, and aging [26]. 13. Astaxanthin IUPAC Name: (6S)-6-Hydroxy-3-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(4S)-4- hydroxy-2,6,6-trimethyl-3-oxo-1-cyclohexenyl]-3,7,12,16-tetramethyloctadeca- 1,3,5,7,9,11,13,15,17-nonaenyl]-2,4,4-trimethyl-1-cyclohex-2-enone Benefits: Astaxanthin has shown potential pharmacological effects against cancer, diabetes, brain related problems, heart related problems, eye and skin related problems [27]. 14. Lactobacillus acidophilus Benefits: Lactobacillus acidophilus is very well known probiotic; it helps to maintain intestinal microbial balance [28]. 15. Beta-carotene IUPAC Name: 1,3,3-trimethyl-2-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16- tetramethyl-18-(2,6,6-trimethylcyclohexen-1-yl)octadeca-1,3,5,7,9,11,13,15,17- nonaenyl]cyclohexene Benefits: β-Carotene is the most common form of carotene in plants. It is an important dietary resource and a precursor of vitamin A in humans [29]. Functions of the same include maintaining vision and maintaining immunity [30]. 16. Rose hip extract Scientific name: Rosa canina Parts used: Flowers (Petals) Major Phytochemical constituents: phenols, ascorbic acid, tocopherols, β-carotene, lycopene, tannins, pectin [31]. Benefits: Rose hips have been used to treat conditions such as joint related problems and diabetes [31]. 17. Wheat Germ oil (GLA) Scientific name: Triticum vulgare Benefits: Wheat germ oil helps to maintain cholesterol level and gut microbiota [32]. Minerals:- 1. Calcium Source: Calcium citrate malate Molecular formula of sources: (C6H7O7)x·(C4H5O5)y·(Ca2+)z Calcium present in source: 21 % [33] Benefits: Calcium helps to reduce blood pressure, reduces possibilities of kidney stones and promotes weight loss [34]. 2. Potassium Source: Potassium Iodide Molecular formula of sources: KI Potassium present in source: 23.55 % Benefits: Potassium helps to reduce the risk of cardiovascular disease and stroke. Potassium also protects against bone loss [35]. 3. Magnesium Source: Magnesium sulphate Molecular formula of sources: MgSO4 Magnesium present in source: 20.1925 % Benefits: Magnesium has several functions in the human body. It acts as a cofactor for more than 300 enzymes, which regulates the number of fundamental functions such as muscle contraction, neuromuscular conduction, myocardial contraction, controlling diabetes and blood pressure [36]. 4. Manganese Source: Manganese sulphate Molecular formula of sources: MnSO4 Manganese present in source: 36.38 % Benefits: Manganese is an essential nutrient required for the formation of bone and also required to regulate amino acid, cholesterol, and carbohydrate metabolism [37]. 5. Zinc Source: Zinc sulphate monohydrate Molecular formula of sources: ZnSO4.H2O Zinc present in source: 36.43 % Benefits: Zinc deficiency results into immune related disorders, diarrhea and altered cognition etc. [37]. 6. Iron Source: Ferrous Fumarate Molecular formula of sources: CuSO4 Iron present in source: 32.86 % Benefits: Iron is required to develop healthy red blood cells which are also known as hemoglobin. Insufficient iron in the body results into Anemia [37]. 7. Copper Source: Copper sulphate Molecular formula of sources: CuSO4 Copper present in source: 39.81 % Benefits: Copper is needed for maintaining proper cholesterol level [38]. 8. Chromium Source: Chromium Picolinate Molecular formula of sources: Cr(C6H4NO2)3 Chromium present in source: 12.43 % Benefits: Chromium has been shown to play an important role in type 2 diabetes mellitus, gestational diabetes, steroid-induced diabetes and glucose intolerance by providing significant beneficial effects of the insulin system, often enhancing insulin sensitivity and overcoming glucose intolerance [39]. 9. Boron Source: Boron citrate Molecular formula of sources: C6H5BO7 Boron present in source: 5.40 % Benefits: Boron prevents bone related problems, central nervous system related problems and cancer. It maintains hormonal balance and immunity within the body [40]. 10. Iodine Source: Potassium Iodide Molecular formula of sources: KI Iodine present in source: 76.45 % Benefits: An inadequate dietary intake of iodine leads to insufficient production of thyroid hormones, which affects many parts of the body, particularly muscle, heart, liver, kidney and the developing brain [41]. 11. Phosphorous Source: Di calcium phosphate IP Molecular formula of source: CaHPO4 Phosphorous present in source: 22.76 % Benefits: Phosphate is one of the most important molecular elements to normal cellular functions within the body. It acts as an integral component of nucleic acids and also it is used to replicate DNA and RNA [42]. 12. Molybdenum Source: Sodium molybdate Molecular formula of sources: Na2MoO4 Molybdenum present in source: 46.59 % Benefits: Molybdenum deficiency causes rapid heart rate, night blindness and headache [42]. 13. Selenium Source: Selenomethionine Molecular formula of source: C5H11NO2Se Selenium present in source: 40.26 % Benefits: Supplementation of selenium may improve atherosclerosis, hypercholesterolemia, type 1 diabetes mellitus [43]. Vitamins:- 1. Vitamin C Molecular formula: C6H8O6 IUPAC name: (2R)-2-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxy-2H-furan-5-one Chemical structure:
Figure imgf000021_0001
Benefits: Vitamin C is essential to prevent scurvy in humans. It is used as the primary prevention of common and complex diseases such as coronary heart disease, stroke, and cancer [44]. 2. Vitamin E Molecular formula: C29H50O2 IUPAC name: (2R)-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4- dihydrochromen-6-ol Chemical structure:
Figure imgf000021_0002
Benefits: Vitamin E has been found to be very effective in the prevention and reversal of various disease complications due to its function as an antioxidant, its role in anti- inflammatory processes, its inhibition of blood clots and its immune-enhancing activity. Vitamin E also possesses anti-cancer properties [45]. 3. Vitamin A Molecular formula: C20H30O IUPAC name: (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona- 2,4,6,8-tetraen-1-ol Chemical structure:
Figure imgf000022_0001
Benefits: Vitamin A's involvement in cell morphogenesis, differentiation, and proliferation is essential to gene regulation. Additionally, its function as an antioxidant decreases free radical damage to DNA. A deficiency in vitamin A is believed to play a role in tumor formation and cancerous cells. [46]. 4. Folic acid Molecular formula: C19H19N7O6 IUPAC name: (2S)-2-[[4-[(2-amino-4-oxo-3H-pteridin-6- yl)methylamino]benzoyl]amino]pentanedioic acid Chemical structure:
Figure imgf000022_0002
Benefits: Folate is necessary for the production and maintenance of new cells, for DNA synthesis and RNA synthesis through methylation, and for preventing changes to DNA [47]. 5. Vitamin K2-7 Molecular formula: C31H46O2 IUPAC name: 2-methyl-3-[(E)-3,7,11,15-tetramethylhexadec-2-enyl]naphthalene-1,4- dione Chemical structure:
Figure imgf000023_0001
Benefits: Vitamin K2-7 has a plethora of potential implications, including prevention and treatment of arterial calcifications, coronary heart disease and cancer. It also improves bone strength and reduces risks of fractures. Vitamin K2-7 has shown improvements in insulin sensitivity [48]. 6. Vitamin D Molecular formula: C27H44O IUPAC name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2- yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4- methylidenecyclohexan-1-ol Chemical structure:
Figure imgf000023_0002
Benefits: Poor vitamin D intake and low blood levels of vitamin D metabolites are associated with increased incidence and severity of several autoimmune diseases involving the T helper type 1 lymphocyte, including multiple sclerosis, rheumatoid arthritis, type I diabetes, systemic lupus erythematosus, and psoriasis. Lower levels of vitamin D, adjusted for body mass index, are also associated with increased risk of hypertension, myocardial infarction, and death as a result of cardiovascular disease [49]. 7. Methylcobalamin Molecular formula: C63H88CoN14O14P IUPAC name: cobalt(3+);[(2R,3S,4R,5S)-5-(5,6-dimethylbenzimidazol-1-yl)-4- hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2R)-1-[3- [(1R,2R,3R,5Z,7S,10Z,12S,13S,15Z,17S,18S,19R)-2,13,18-tris(2-amino-2-oxoethyl)- 7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2,7,12,17- tetrahydro-1H-corrin-24-id-3-yl]propanoylamino]propan-2-yl] phosphate;cyanide Chemical structure:
Figure imgf000024_0001
Benefits: Symptoms of methylcobalamin deficiency include anemia, neuropathy, and neuropsychiatric disorders, but it more commonly leads to nonspecific tiredness or discomfort in older people [50]. 8. Biotin Molecular formula: C10H16N2O3S IUPAC name: 5-[(3aS,4S,6aR)-2-oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol- 4-yl]pentanoic acid Chemical structure:
Figure imgf000025_0001
Benefits: This vitamin, Biotin is involved in the regulation of fatty acid synthesis and it also influences the carbohydrate metabolism. More recently, the role of biotin in the regulation of gene expression has also been established [51]. 9. Vitamin B3 Molecular formula: C6H5NO2 IUPAC name: pyridine-3-carboxylic acid Chemical structure:
Figure imgf000025_0002
Benefits: Vitamin B3, also known as Niacin possesses anti-oxidative and anti- inflammatory activities. These activities decrease the risk of cardiovascular disease [52]. 10. Vitamin B5 Molecular formula: C9H17NO5 IUPAC name: 3-[[(2R)-2,4-dihydroxy-3,3-dimethylbutanoyl]amino]propanoic acid Chemical structure:
Figure imgf000026_0001
Benefits: Vitamin B5 has been shown to reduce many signs of skin aging, including hyper pigmentation and redness [53]. Vitamin B5 improves the texture of skin giving shiny and healthy looking skin. 11. Vitamin B2 Molecular formula: C17H20N4O6 IUPAC name: 7,8-dimethyl-10-[(2S,3S,4R)-2,3,4,5- tetrahydroxypentyl]benzo[g]pteridine-2,4-dione Chemical structure:
Figure imgf000026_0002
Benefits: Vitamin B2 also known as, Riboflavin is a water-soluble and heat-stable vitamin that the body uses to metabolize fats, protein, and carbohydrates into glucose for energy. Riboflavin is used as an antioxidant for proper function of the immune system, healthy skin and hair. This is done with the help of two main coenzymes, flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD). Without an adequate amount of riboflavin, macros like carbohydrates, fats, and proteins cannot be digested properly [54]. 12. Vitamin B1 Molecular formula: C12H17ClN4OS IUPAC name: 2-[3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol- 3-ium-5-yl]ethanol;chloride Chemical structure:
Figure imgf000027_0001
Benefits: Wernicke-Korsakoff syndrome (WKS) and Beriberi are the two most common complications that may arise from a thiamin or vitamin B1 deficiency, though these two syndromes rarely occur at same time in an individual. WKS affects the central nervous system, which involves the brain and spinal cord. Beriberi is another disorder caused by a thiamin or vitamin B1 deficiency. Early on, symptoms of beriberi include constipation, appetite suppression, nausea, mental depression, fatigue, peripheral neuropathy, anorexia, and weight loss. With progression, chronic symptoms can begin to manifest as either wet beriberi or dry beriberi. Wet beriberi presents with edema, an enlarged heart, cardiac failure etc [55]. 13. Vitamin B6 Molecular formula: C8H11NO3 IUPAC name: 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol Chemical structure:
Figure imgf000028_0001
Benefits: Vitamin B6 is an interesting micronutrient that mediates numerous metabolic processes in vivo including amino acid metabolism, gluconeogenesis, lipid metabolism, and nervous system development and functioning. Vitamin B6 has been implicated in the regulation of immune responses that are associated with a wide range of diseases, including inflammation and various cancers [56]. Amino acids: 1. L-lysine Chemical formula: C6H14N2O2 IUPAC name: (2S)-2,6-diaminohexanoic acid Chemical structure:
Figure imgf000028_0002
Benefits: Upon oral intake, L-lysine promotes healthy tissue function, growth and healing and improves the immune system. L-Lysine promotes calcium uptake, is essential for carnitine production and collagen formation. Collagen is essential for connective tissue maintenance [57]. 2. L-Arginine Chemical formula: C6H14N4O2 IUPAC name: [(4S)-4-amino-4-carboxybutyl]-(diaminomethylidene)azanium Chemical structure:
Figure imgf000029_0001
Benefits: Arginine may prevent or treat heart and circulatory diseases, combat fatigue, and stimulate the immune system. It also boosts production of nitric oxide, relaxing blood vessels and treating angina and other cardiovascular problems [58]. B) L-arginine, in an amount that is safe for comsumption by humans, and is safe for consumption by humans, and is safe for developing fetuses or breast-fed babies of pregnant or lactating women, and that is effective for enhancing vascular, neutolocial or immune function in humans or insulin sensitivity in diabetic humans;
3. L-Methionine Chemical formula: C5H11NO2S IUPAC name: (2S)-2-amino-4-methylsulfanylbutanoic acid Chemical structure:
Figure imgf000030_0001
Benefits: Methionine is one of nine essential amino acids in humans (provided by food), Methionine is required for growth and tissue repair. A sulphur-containing amino acid, methionine improves the tone and pliability of skin, hair, and strengthens nails [59]. 4. L-Phenylalanine Chemical formula: C9H11NO2 IUPAC name: (2S)-2-amino-3-phenylpropanoic acid Chemical structure:
Figure imgf000030_0002
Benefits: Phenylalanine Used by the brain to produce Norepinephrine, a chemical that transmits signals between nerve cells and the brain; keeps you awake and alert; reduces hunger pains; functions as an antidepressant and helps improve memory [60]. 5. L-Tryptophan Chemical formula: C11H12N2O2 IUPAC name: (2S)-2-amino-3-(1H-indol-3-yl)propanoic acid Chemical structure:
Figure imgf000031_0001
Benefits: Dietary tryptophan and its metabolites seem to have the potential to contribute to the therapy of autism, cardiovascular disease, cognitive function, chronic kidney disease, depression, inflammatory bowel disease, multiple sclerosis, sleep, social function and microbial infections [61]. 6. L-Carnitine Chemical formula: C7H15NO3 IUPAC name: 3-hydroxy-4-(trimethylazaniumyl)butanoate Chemical structure:
Figure imgf000031_0002
Benefits: Carnitine deficiency is not as rare and is most commonly associated with dialysis in chronic renal failure, although it can also be induced by intestinal resection, severe infection, and liver disease. Other conditions associated with a carnitine deficiency include cancer, diabetes, Alzheimer's disease, and heart failure [62]. 7. L-Valine Chemical formula: C5H11NO2 IUPAC name: (2S)-2-amino-3-methylbutanoic acid Chemical structure:
Figure imgf000032_0001
Benefits: L-Valine a branched-chain amino acid, that enhances energy, increases endurance and aids in muscle tissue recovery and repair [63
Figure imgf000032_0002
8. L-Histidine Chemical formula: C6H9N3O2 IUPAC name: (2S)-2-amino-3-(1H-imidazol-5-yl)propanoic acid Chemical structure:
Figure imgf000032_0003
Benefits: Histidine is a semi-essential amino acid (children should obtain it from food) needed in humans for growth and tissue repair. Histidine is important for maintenance of myelin sheaths that protect nerve cells and is metabolized to the neurot ransmitter histamine. Histamines play many roles in immunity, gastric secretion, and sexual functions. Histidine is also required for blood cell manufacture and protects tissues against damage caused by radiation and heavy metals [64].
9. L-Leucine Chemical formula: C6H13NO2 IUPAC name: (2S)-2-amino-4-methylpentanoic acid Chemical structure:
Figure imgf000033_0001
Benefits: An essential amino acid. Leucine helps with the regulation of blood-sugar levels, the growth and repair of muscle tissue (such as bones, skin and muscles), growth hormone production, and wound healing as well as energy regulation [65]. 10. L-Isoleucine Chemical formula: C6H13NO2 IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acid Chemical structure:
Figure imgf000033_0002
Benefits: L-Isoleucine is one of nine essential amino acids in humans (present in dietary proteins), L-Isoleucine has diver se physiological functions, such as assisting wound healing, detoxification of nitrogenous wastes, stimulating immune function, and promoting secretion of several hormones. Necessary for hemoglobin formation and regulating blood sugar and energy levels, L-Isoleucine is concentrated in muscle tissues in humans [66]. 11. L-Threonine Chemical formula: C4H9NO3 IUPAC name: (2S,3R)-2-amino-3-hydroxybutanoic acid Chemical structure:
Figure imgf000034_0001
Benefits: L-Threonine is an essential amino acid that helps to maintain the proper protein balance in the body. It is important for the formation of collagen, elastin, and tooth enamel [67]. 10 ) Manufacturing Technology: Technologies which are used while preparing these capsules are: (a) Phyto-Alkatech – This technology is used to neutralize acidic ingredients and to reduce gastric irritation. It also enhances absorption of all ingredients. (b) Syner-Tech – This technology is used to make sure better working of all the ingredients present. This technology also increases beneficial effects of multiple ingredients. Process or mixing Raw materials are weighed as per the batch size. These materials are then added to the vessel of drum mixer for mixing, which is made up of stainless steel. Mixing is done for duration of 30 minutes. All the powdered raw materials are added altogether. Liquid materials were sprayed on powdered raw material in regular intervals during mixing. As all the raw materials are heat sensitive, the temperature has been maintained at 250 C throughout the mixing. Also, humidity level was retained under 40% RH to avoid any condensation. Capsule or pouch filing Capsules are first checked for any tempering and consistent weight. At first few of the capsules are checked, if the filling machine delivers the stated amount of filling. Once satisfied, filling is done for the whole batch using Hand Operated Capsule Filling Machine. First capsules are put into the capsules loading tray. Then the capsules are separated in cap and body. Body of the capsules are filled with the mixture first then the cap of the capsule is pressed and locked down. Each time 300 of capsules is filled. Capsule polishing Capsules are then polished with the help of a Turkish cotton cloth with glycerin. Turkish cotton cloth removes any dust or excess of mixture from the exterior of the capsules. Glycerin gives shine to the capsules from outside. Capsules are checked visually for any abnormally looking capsules, which are then discarded. Capsules are then put on the capsule tray. Once this is done, the capsule tray is then taken over to the packaging area. Quality analysis Mixed powder is undergoing for a quality check to see whether the raw materials are equally distributed or not. If not then batch is subjected to reprocessing. Capsules at the final stage also undergo a quality analysis to retain optimum results. Control samples from each batch of production are stored again to conduct all the tests. The limits for the ingredients intake are under the guidelines of United States Pharmacopeia (USP) 561 and Food Safety and Standards Regulations (FSSR) 2011 methods.

Claims

CLAIM: 1. A product according to the present invention is a nutritional capsule for men and women having ayurvedic herbs, unani herbs, minerals, amino acids, vitamins, probiotic and nutraceuticals which reduces side effect of some ingredients and by using technologies it neutralizes acidic ingredients and reduces gastric irritation and provides absorption of all ingredients.
2. The product according to the present invention as claimed in claim 1 in which contains the Ayurvedic and Unani Herbal extracts such as Guduchi (Tinospora cordifolia), Jathikka (Myristica fragrans), Satawar (Asparagus racemosus), khadir (Vachellia nilotica), Habb al sawda (Nigella sativa), Muringa (Moringa oleifera), Medhika (Trigonella foenum graecum), Amalaki (Phyllanthus emblica), Bilberry (Vaccinium myrtillus), Pomegranate (Punica granatum), Olive (Olea europaea), Hasak (Tribulus terrestris) and Salab misri (Orchis latifolia).
3. The product according to the present invention also contains Nutraceuticals – Botanicals such as Omega-3 Fatty Acids, MSM, Colostrum, Ginseng, Grape Seed Extract, Green Tea Extract, Citrus Bioflavonoid, Inulin, CoEnzyme Q10, Beta- Carotene, Lycopene, Wheat Germ Oil, Rose Hip Extract, Zeaxanthin, Astaxanthin and Lutein.
4. The product as claimed in claim 1 contains the probiotic, Amino acids such as Lactobacillus acidophilus, L-Lysine, L-Arginine, L-Tryptophan, L-Carnitine, L- Methionine, L-Phenylalanine, L-Valine, L-Histidine, L-Leucine, L-Isoleucine and L- Threonine.
5. The product according to the present invention also contains also contains vitamins such as Vitamin C, Vitamin B3, Vitamin E, Vitamin B5, Vitamin B6, Vitamin B2, Vitamin B1, Methylcobalamin, Vitamin A, Vitamin B9, Vitamin K2-7, Biotin, and Vitamin D.
6. The product as claimed in claim 1 contains minerals such as Calcium, Iron, Phosphorous, Zinc, Manganese, Magnesium, Iodine, Copper, Selenium, Molybdenum, Chromium, Potassium and Boron.
PCT/IN2022/050713 2021-08-13 2022-08-08 A nutritional capsule of ayurvedic herbs, unani herbs, minerals, amino acids, vitamins, probiotic and nutraceuticals WO2023017533A1 (en)

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