CN111035620B - 一种辅料组合物、植物甾醇复合营养素咀嚼片及其制备方法 - Google Patents
一种辅料组合物、植物甾醇复合营养素咀嚼片及其制备方法 Download PDFInfo
- Publication number
- CN111035620B CN111035620B CN201911332320.6A CN201911332320A CN111035620B CN 111035620 B CN111035620 B CN 111035620B CN 201911332320 A CN201911332320 A CN 201911332320A CN 111035620 B CN111035620 B CN 111035620B
- Authority
- CN
- China
- Prior art keywords
- phytosterol
- chewable tablet
- tablet
- powder
- preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000007910 chewable tablet Substances 0.000 title claims abstract description 56
- 229940068682 chewable tablet Drugs 0.000 title claims abstract description 40
- 239000000203 mixture Substances 0.000 title claims abstract description 25
- 239000000463 material Substances 0.000 title claims abstract description 17
- 235000015097 nutrients Nutrition 0.000 title abstract description 25
- 150000001875 compounds Chemical class 0.000 title abstract description 16
- 238000002360 preparation method Methods 0.000 title abstract description 14
- GXCLVBGFBYZDAG-UHFFFAOYSA-N N-[2-(1H-indol-3-yl)ethyl]-N-methylprop-2-en-1-amine Chemical compound CN(CCC1=CNC2=C1C=CC=C2)CC=C GXCLVBGFBYZDAG-UHFFFAOYSA-N 0.000 claims abstract description 18
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 17
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 17
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 17
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 17
- 239000003826 tablet Substances 0.000 claims abstract description 15
- 239000000905 isomalt Substances 0.000 claims abstract description 13
- 235000010439 isomalt Nutrition 0.000 claims abstract description 13
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims abstract description 13
- 239000002671 adjuvant Substances 0.000 claims abstract description 11
- BTCSSZJGUNDROE-UHFFFAOYSA-N gamma-aminobutyric acid Chemical compound NCCCC(O)=O BTCSSZJGUNDROE-UHFFFAOYSA-N 0.000 claims description 30
- 239000000843 powder Substances 0.000 claims description 29
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 22
- 239000008187 granular material Substances 0.000 claims description 20
- 102000015636 Oligopeptides Human genes 0.000 claims description 18
- 108010038807 Oligopeptides Proteins 0.000 claims description 18
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 17
- SERLAGPUMNYUCK-YJOKQAJESA-N 6-O-alpha-D-glucopyranosyl-D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-YJOKQAJESA-N 0.000 claims description 16
- OGNSCSPNOLGXSM-UHFFFAOYSA-N (+/-)-DABA Natural products NCCC(N)C(O)=O OGNSCSPNOLGXSM-UHFFFAOYSA-N 0.000 claims description 15
- 235000010469 Glycine max Nutrition 0.000 claims description 15
- 238000001035 drying Methods 0.000 claims description 15
- 229960003692 gamma aminobutyric acid Drugs 0.000 claims description 15
- 235000013557 nattō Nutrition 0.000 claims description 15
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 15
- 150000003904 phospholipids Chemical class 0.000 claims description 14
- 240000008042 Zea mays Species 0.000 claims description 13
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 claims description 13
- 235000002017 Zea mays subsp mays Nutrition 0.000 claims description 13
- 235000005822 corn Nutrition 0.000 claims description 13
- 244000068988 Glycine max Species 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 12
- 239000004376 Sucralose Substances 0.000 claims description 11
- 235000019359 magnesium stearate Nutrition 0.000 claims description 11
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims description 11
- 235000019408 sucralose Nutrition 0.000 claims description 11
- 238000009835 boiling Methods 0.000 claims description 10
- 238000004519 manufacturing process Methods 0.000 claims description 10
- 235000010355 mannitol Nutrition 0.000 claims description 9
- 229940068065 phytosterols Drugs 0.000 claims description 6
- 239000005913 Maltodextrin Substances 0.000 claims description 5
- 229920002774 Maltodextrin Polymers 0.000 claims description 5
- 239000011230 binding agent Substances 0.000 claims description 5
- 229940035034 maltodextrin Drugs 0.000 claims description 5
- 102000004196 processed proteins & peptides Human genes 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 abstract 1
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 24
- 210000004369 blood Anatomy 0.000 description 17
- 239000008280 blood Substances 0.000 description 17
- 230000001603 reducing effect Effects 0.000 description 14
- 230000000694 effects Effects 0.000 description 11
- 208000032928 Dyslipidaemia Diseases 0.000 description 10
- 108010028554 LDL Cholesterol Proteins 0.000 description 10
- 208000017170 Lipid metabolism disease Diseases 0.000 description 10
- 235000002378 plant sterols Nutrition 0.000 description 10
- 238000012360 testing method Methods 0.000 description 10
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 10
- 235000012000 cholesterol Nutrition 0.000 description 9
- 108010007622 LDL Lipoproteins Proteins 0.000 description 8
- 102000007330 LDL Lipoproteins Human genes 0.000 description 8
- 239000002131 composite material Substances 0.000 description 8
- 150000002632 lipids Chemical class 0.000 description 7
- 208000024172 Cardiovascular disease Diseases 0.000 description 6
- 241000196324 Embryophyta Species 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 201000001320 Atherosclerosis Diseases 0.000 description 4
- 241001465754 Metazoa Species 0.000 description 4
- FFRBMBIXVSCUFS-UHFFFAOYSA-N 2,4-dinitro-1-naphthol Chemical compound C1=CC=C2C(O)=C([N+]([O-])=O)C=C([N+]([O-])=O)C2=C1 FFRBMBIXVSCUFS-UHFFFAOYSA-N 0.000 description 3
- 241000699673 Mesocricetus auratus Species 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 238000010924 continuous production Methods 0.000 description 3
- 235000013312 flour Nutrition 0.000 description 3
- 206010003210 Arteriosclerosis Diseases 0.000 description 2
- 241000699800 Cricetinae Species 0.000 description 2
- 208000035150 Hypercholesterolemia Diseases 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 235000013376 functional food Nutrition 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 235000009200 high fat diet Nutrition 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 235000018102 proteins Nutrition 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- JLPULHDHAOZNQI-ZTIMHPMXSA-N 1-hexadecanoyl-2-(9Z,12Z-octadecadienoyl)-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/C\C=C/CCCCC JLPULHDHAOZNQI-ZTIMHPMXSA-N 0.000 description 1
- ZNQVEEAIQZEUHB-UHFFFAOYSA-N 2-ethoxyethanol Chemical compound CCOCCO ZNQVEEAIQZEUHB-UHFFFAOYSA-N 0.000 description 1
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 208000023275 Autoimmune disease Diseases 0.000 description 1
- 102000014914 Carrier Proteins Human genes 0.000 description 1
- 108010078791 Carrier Proteins Proteins 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 235000009917 Crataegus X brevipes Nutrition 0.000 description 1
- 235000013204 Crataegus X haemacarpa Nutrition 0.000 description 1
- 235000009685 Crataegus X maligna Nutrition 0.000 description 1
- 235000009444 Crataegus X rubrocarnea Nutrition 0.000 description 1
- 235000009486 Crataegus bullatus Nutrition 0.000 description 1
- 235000017181 Crataegus chrysocarpa Nutrition 0.000 description 1
- 235000009682 Crataegus limnophila Nutrition 0.000 description 1
- 235000004423 Crataegus monogyna Nutrition 0.000 description 1
- 240000000171 Crataegus monogyna Species 0.000 description 1
- 235000002313 Crataegus paludosa Nutrition 0.000 description 1
- 235000009840 Crataegus x incaedua Nutrition 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 206010019663 Hepatic failure Diseases 0.000 description 1
- 244000131316 Panax pseudoginseng Species 0.000 description 1
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
- 108010064851 Plant Proteins Proteins 0.000 description 1
- 208000001647 Renal Insufficiency Diseases 0.000 description 1
- 241000555745 Sciuridae Species 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 238000010171 animal model Methods 0.000 description 1
- 230000000049 anti-anxiety effect Effects 0.000 description 1
- 230000003064 anti-oxidating effect Effects 0.000 description 1
- 239000002249 anxiolytic agent Substances 0.000 description 1
- 239000007900 aqueous suspension Substances 0.000 description 1
- 235000014590 basal diet Nutrition 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 235000018927 edible plant Nutrition 0.000 description 1
- 238000004945 emulsification Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 235000008524 evening primrose extract Nutrition 0.000 description 1
- 239000010475 evening primrose oil Substances 0.000 description 1
- 229940089020 evening primrose oil Drugs 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000013401 experimental design Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 235000021323 fish oil Nutrition 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000014509 gene expression Effects 0.000 description 1
- 235000008434 ginseng Nutrition 0.000 description 1
- 230000007365 immunoregulation Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 201000006370 kidney failure Diseases 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 108010022197 lipoprotein cholesterol Proteins 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 208000007903 liver failure Diseases 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000000691 measurement method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229940086319 nattokinase Drugs 0.000 description 1
- 108010073682 nattokinase Proteins 0.000 description 1
- 239000002858 neurotransmitter agent Substances 0.000 description 1
- 230000000508 neurotrophic effect Effects 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000001766 physiological effect Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 229940026314 red yeast rice Drugs 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000029865 regulation of blood pressure Effects 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 229940083466 soybean lecithin Drugs 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 230000002537 thrombolytic effect Effects 0.000 description 1
- 230000004614 tumor growth Effects 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
Classifications
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L11/00—Pulses, i.e. fruits of leguminous plants, for production of food; Products from legumes; Preparation or treatment thereof
- A23L11/50—Fermented pulses or legumes; Fermentation of pulses or legumes based on the addition of microorganisms
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
- A23L29/37—Sugar alcohols
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
- A23L33/11—Plant sterols or derivatives thereof, e.g. phytosterols
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/115—Fatty acids or derivatives thereof; Fats or oils
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/17—Amino acids, peptides or proteins
- A23L33/18—Peptides; Protein hydrolysates
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L7/00—Cereal-derived products; Malt products; Preparation or treatment thereof
- A23L7/20—Malt products
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/20—Agglomerating; Granulating; Tabletting
- A23P10/28—Tabletting; Making food bars by compression of a dry powdered mixture
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/01—Hydrolysed proteins; Derivatives thereof
- A61K38/011—Hydrolysed proteins; Derivatives thereof from plants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
-
- 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
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- 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
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
-
- 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
- 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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2063—Proteins, e.g. gelatin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Nutrition Science (AREA)
- Polymers & Plastics (AREA)
- Food Science & Technology (AREA)
- Molecular Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Botany (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Mycology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Zoology (AREA)
- Physiology (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Microbiology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Agronomy & Crop Science (AREA)
- Biotechnology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
本申请涉及一种辅料组合物、植物甾醇复合营养素咀嚼片及其制备方法。特别地,本申请涉及一种用于制备咀嚼片的辅料组合物,其以16‑24:18‑26:0.5‑2.0的比例包含异麦芽酮糖醇、微晶纤维素和炒麦芽。本申请还提供包含上述辅料的植物甾醇咀嚼片及其制备方法。本申请提供的辅料组合物能够减少片剂制备过程中粘冲的发生,并且能够提高植物甾醇的添加量。
Description
技术领域
本发明涉及一种辅料组合物和含有该辅料组合物的植物甾醇咀嚼片。本发明还涉及一种植物甾醇咀嚼片的制备方法。
背景技术
2012年全国血脂调查结果显示,我国成人血脂异常总体患病率高达40.0%,人群血清胆固醇水平的升高将导致2010年-2030年期间我国心血管疾病将增加约920万。我国儿童青少年高胆固醇血症患病率也有明显升高,预示未来中国成人血脂异常患病率及相关疾病负担都将持续加重。
血脂异常是心血管疾病的首要风险因素,其中高胆固醇血症是导致动脉粥样硬化的独立风险因素,高低密度脂蛋白胆固醇是导致动脉粥样硬化的必要条件。降低低密度脂蛋白胆固醇和总胆固醇水平,可显著减少动脉粥样硬化性心血管疾病的发病及死亡风险。有效控制血脂异常,对我国防治动脉粥样硬化性心血管疾病具有重要意义。
市售以植物甾醇作为主要活性成分的降血脂功能性食品或保健品组方常见为植物甾醇与大豆卵磷脂、鱼油、月见草油、红曲等常见降血脂活性成分搭配,或与山楂、人参等传统药材搭配。植物甾醇性质发粘,因此,传统含有植物甾醇的功能性食品在生产过程中常常发生粘冲,因而导致生产中断,影响生产效率。
发明内容
为了解决上述技术问题,本发明提供一种用于咀嚼片的辅料组合物,其以16-24:18-26:0.5-2.0的比例包含异麦芽酮糖醇、微晶纤维素和炒麦芽。
植物甾醇性质发粘,在加工片剂过程中容易粘住压片机冲头,需要中断生产以清除冲头上的粘粘物。本发明提供的辅料组合物可以解决植物甾醇片剂制备过程中的粘冲头的问题,能够更长时间的连续生产。
本发明的目的还在于提供一种植物甾醇复合营养素咀嚼片及其制备方法。在一些实施例中,本发明的植物甾醇咀嚼片还包含:植物甾醇、植物低聚肽、磷脂、γ-氨基丁酸和纳豆粉。
本发明还提供一种用于制备上述植物甾醇咀嚼片的方法,其包括以下步骤:
1):所有原辅料分别过60目筛。
2):将过筛后的植物甾醇、大豆肽、玉米低聚肽、磷脂、D-甘露糖醇、微晶纤维素、异麦芽酮糖醇、麦芽粉、γ-氨基丁酸的几种或全部按照比例置于湿法制粒机中混合均匀,以水为粘合剂制粒。
3):用沸腾干燥机烘干,先烘半干,再用16目筛制粒。
4):经步骤3)所得的半干颗粒再用沸腾干燥机烘干,水分控制在4.0%~4.5%左右,再用20目筛整粒,控制颗粒与粉的比例接近1:1.
5):将步骤4)所得的干颗粒与纳豆粉、硬脂酸镁、三氯蔗糖的几种或全部置于混合机内,混合均匀。
6):用旋转式压片机压片。
具体实施方式
本申请的第一方面提供一种用于制备咀嚼片的辅料组合物,其以16-24:18-26:0.5-2.0的比例包含异麦芽酮糖醇、微晶纤维素和炒麦芽。本申请的辅料组合物还可以包含:麦芽糊精、D-甘露糖醇、硬脂酸镁、三氯蔗糖中的一种或几种。
本申请中提供的异麦芽酮糖醇、微晶纤维素和炒麦芽粉的组合能够出人意料地减少压片过程中粘冲头的问题,提高生产效率,同时还能够减少裂片的产生,有利于获得硬度适宜、质量合格的咀嚼片。
在一些实施例中,辅料组合物中异麦芽酮糖醇、微晶纤维素和炒麦芽的比例为16-24:18-26:0.5-2.0,优选为18-22:20-24:0.5-1.5,更优选为19-21:18-22:1。
本申请的第二方面提供一种植物甾醇咀嚼片,其包含本申请中所描述的辅料组合物。在一些实施例中本申请的植物甾醇咀嚼片包括植物甾醇、大豆肽。在一些实施例中,本申请的植物甾醇咀嚼片还包含:玉米低聚肽、磷脂、γ-氨基丁酸和纳豆粉。
植物甾醇,与胆固醇具有相似的结构,能够通过在消化道内与胆固醇竞争吸收位点、抑制胆固醇转运蛋白基因表达和减少胆固醇再酯化等方式能够减少30%~50%的饮食中胆固醇吸收,此外植物甾醇还能够提高体内胆固醇的清除,具有降低血清胆固醇和低密度脂蛋白胆固醇水平的作用。植物甾醇是中国、欧洲、美国等多个国家以及ESC/EAS等医学协会指南和共识均推荐血脂异常人群食用以帮助降低血脂和预防心血管疾病,推荐剂量为2~3g/天。
植物低聚肽是指来源于可食用植物蛋白,分子结构介于氨基酸和蛋白质之间的一类化合物。植物低聚肽相比蛋白质,溶解性增强,吸收更好。具有免疫调节、抗氧化、调节血压和抑制肿瘤生长等多种生理活性。在一些实施例中,植物低聚肽包括大豆肽、玉米低聚肽或其组合。
γ-氨基丁酸是一种广泛分布在动植物体内的活性物质,是大脑中最重要的神经递质之一,具有神经营养、抗焦虑、促进血管扩张和参与镇痛的作用。
磷脂具有亲水、亲油的乳化作用,能参与脂肪和胆固醇的运输,降低血清胆固醇、甘油三酯、低密度脂蛋白胆固醇。是公认的有益于血脂健康的营养素。
纳豆富含纳豆激酶,是一种天然的溶纤酶,具有溶栓的作用。
通过植物甾醇、植物低聚肽、磷脂、γ-氨基丁酸和纳豆粉的组合,本申请提供的咀嚼片可以起到降低胆固醇和低密度脂蛋白胆固醇的作用,从而保护心血管,预防心血管疾病的发生。
在一些实施例中,物甾醇复合营养素咀嚼片由以下组分构成:植物甾醇、大豆肽粉、磷脂、玉米低聚肽粉、γ-氨基丁酸、纳豆粉、异麦芽酮糖醇、D-甘露糖醇、微晶纤维素、炒麦芽、硬脂酸镁、三氯蔗糖。
现有技术中,植物甾醇通常以10%-15%的量添加到咀嚼片中。而本申请前述辅料组合物能够出人意料地提高片剂中植物甾醇的添加量。例如,本申请提供的咀嚼片通过添加前述辅料组合物能够使每一片咀嚼片中植物甾醇的添加量增加到16%-20%,甚至高达21%-25%。
在一些实施例中,基于本申请咀嚼片的总重量,植物甾醇的量为16%~25%,优选为17%~24%,更优选为18%~22%。例如,植物甾醇的含量可以为16%、17%、18%、19%、19.5%、20%、20.5%、21%、21.5%、22%、23%、24%、25%或上述数值之间的任意范围。
在一些实施例中,基于本申请咀嚼片的总重量,大豆肽、玉米低聚肽和磷脂的含量各自为1%~10%,优选为3%~7%,更优选为4%~6%。例如,大豆肽、玉米低聚肽和磷脂的含量各自可以为约1%、2%、3%、4%、5%、6%、7%、8%、9%、10%或上述数值之间的任意范围。
在一些实施例中,基于本申请咀嚼片的总重量,γ-氨基丁酸和纳豆粉的含量各自为1%~5%,优选为1%~3%,更优选为1%~2%。例如,γ-氨基丁酸和纳豆粉的含量各自可以为约1.0、1.25%、1.5%、2.0%、3.0%、4.0%、5.0%或上述数值之间的任意范围。
在一些实施例中,基于本申请咀嚼片的总重量,异麦芽酮糖醇、微晶纤维素和D-甘露糖醇的含量各自为16%~28%,优选为16%~24%,更优选为18%~22%。例如,植物甾醇的含量可以为16%、17%、18%、19%、19.5%、20%、20.5%、21%、21.5%、22%、23%、24%、25%、26%、27%、28%或上述数值之间的任意范围。
在一些实施例中,基于本申请咀嚼片的总重量,炒麦芽的量为1%~5%,优选为1%~3%,更优选为1%~2%。
在一些实施例中,基于本申请组合物的总重量,硬脂酸镁的量为1%~6%,优选为1%~4%,更优选为1%~3%。
在一些实施例中,基于本申请组合物的总重量,三氯蔗糖的量为0.01%~0.08%,优选为0.02%~0.07%,更优选为0.03%~0.06%。
本申请中提供的植物甾醇复合营养素咀嚼片,经动物试验和人群试食试验证实,具有降低总胆固醇、总甘油三酯、低密度脂蛋白胆固醇的作用,可以预防心血管疾病发生。
本申请的另一方面提供一种用于制备本文中所描述的植物甾醇咀嚼片的方法,其包括以下步骤:
1):所有原辅料分别过60目筛。
2):将过筛后的植物甾醇、大豆肽、玉米低聚肽、磷脂、D-甘露糖醇、微晶纤维素、异麦芽酮糖醇、麦芽糊精、麦芽粉、γ-氨基丁酸的几种或全部按照比例置于湿法制粒机中混合均匀,以水为粘合剂制粒。
3):用沸腾干燥机烘干,先烘半干,再用16目筛制粒。
4):经步骤3)所得的半干颗粒再用沸腾干燥机烘干,水分控制在4.0%~4.5%左右,再用20目筛整粒,控制颗粒与粉的比例接近1:1.
5)将步骤4)所得的干颗粒与纳豆粉、硬脂酸镁、三氯蔗糖的几种或全部置于混合机内,混合均匀。
6)用旋转式压片机压片。
本发明还提供了一种降血脂植物甾醇复合营养素咀嚼片的制备方法,本申请的发明人出人意料地发现通过添加异麦芽酮糖醇、微晶纤维素、炒麦芽粉并控制三者在合适的比例,能够使片剂中植物甾醇的添加量提高到21%-25%,同时解决生产工艺过程中常出现的裂片、粘冲的问题。
本发明的有益之处在于,本发明提供了一种降血脂植物甾醇复合营养素咀嚼片及其制备方法,通过植物甾醇、大豆肽、玉米低聚肽、γ-氨基丁酸、磷脂、纳豆粉的协同作用,无需服用推荐剂量2-3g植物甾醇也能有效的降低血脂,降血脂的效果短期呈现剂量依赖效应,长期效果低(0.48g/d)、中(0.96g/d)、高(1.32g/d)相一致。
实施例
下面结合实施例对本发明作进一步详细的描述,但本发明的实施方式不限于此。
实施例1:降血脂植物甾醇复合营养素咀嚼片
植物甾醇21%,大豆肽粉10.95%,麦芽糊精21%、异麦芽酮糖醇22%、微晶纤维素22%、炒麦芽粉1%、硬脂酸镁2%、三氯蔗糖0.05%
采用以下制备步骤得到:
1):所有原辅料分别过60目筛。
2):将过筛后的植物甾醇、大豆肽粉、麦芽糊精、微晶纤维素、异麦芽酮糖醇、炒麦芽粉置于湿法制粒机中混合均匀,以水为粘合剂制粒。
3):用沸腾干燥机烘干,先烘半干,再用16目筛制粒。
4):制好的半干颗粒再用沸腾干燥机烘干,水分控制在4.0%~4.5%左右,再用20目筛整粒,控制颗粒与粉的比例接近1:1。
5)将前述干颗粒、硬脂酸镁、三氯蔗糖置于混合机内,混合均匀。
6)用旋转式压片机压片。
实施例2:降血脂植物甾醇复合营养素咀嚼片
植物甾醇20%,大豆肽5%,磷脂5%、玉米低聚肽4%、γ-氨基丁酸1.25%、纳豆粉1.5%、异麦芽酮糖醇20%、D-甘露糖醇20%、微晶纤维素20%、炒麦芽粉1.2%、硬脂酸镁2%、三氯蔗糖0.05%
1):所有原辅料分别过60目筛。
2):将过筛后的植物甾醇、大豆肽、磷脂、玉米低聚肽、γ-氨基丁酸、D-甘露糖醇、微晶纤维素、异麦芽酮糖醇、炒麦芽粉置于湿法制粒机中混合均匀,以水为粘合剂制粒。
3):用沸腾干燥机烘干,先烘半干,再用16目筛制粒。
4):制好的半干颗粒再用沸腾干燥机烘干,水分控制在4.0%~4.5%左右,再用20目筛整粒,控制颗粒与粉的比例接近1:1。
5)将前述干颗粒、纳豆粉、硬脂酸镁、三氯蔗糖置于混合机内,混合均匀。
6)用旋转式压片机压片。
实施例3:对具备降血脂功效植物甾醇复合营养素咀嚼片进行动物试验
实验动物:Syrian金黄地鼠,♂,6~8周龄,体质量90~110g,够自北京维通利华实验动物中心,许可证号:SCXK(京)2012-0001。金黄地鼠常规饲料和高脂饲料,均由北京华阜康生物科技股份有限公司提供,生产许可证:SCXK(京)2014-0008。常规饲料可以满足金黄地鼠所有的营养需求,金黄地鼠在SPF级环境中饲养【许可证号SYXK(京)2013-0023】,温度(22.0±2.0)℃,湿度50%~70%,10只/笼,12h昼夜交替,定量给与常规饲料或高脂饲料,自由饮水。
试剂:血清总胆固醇(TC)批号141281、甘油三酯(TG)批号150821、低密度脂蛋白胆固醇(LDL-C)批号150781,以上测定试剂盒均够自中生北控生物科技股份有限公司。
动物及处理:50只Syrian金黄地鼠适应性饲养1周。第2周起,根据体质量随机分成5组:正常对照组、模型组、低剂量组(以植物甾醇计70mg/kg)、中剂量组(以植物甾醇计140mg/kg)、高剂量组(以植物甾醇计280mg/kg),每组10只。正常对照组喂基础饲料,其他各组喂高脂饲料。1周后,测定各组金黄地鼠的血脂水平(TC、TG、LDL-C),确定模型成立。各模型组根据血脂结果进行组间调整,使模型组和各给药组血脂水平无组间差异。实验组各组分别灌胃一定剂量的植物甾醇复合营养素咀嚼片的水混悬液,连续给药四周。正常对照组和模型组分别灌胃等体积的蒸馏水。末次给药后禁食不禁水12h,麻醉眼眶取血,分离血清,测定血脂指标。
试验结果:相比模型组,口服植物甾醇复合营养素咀嚼片4周,低、中、高剂量组都能降低高脂饮食导致的TC、TG和LDL-C,呈剂量-效果相关性。
注:相比模型组,*p<0.05,**p<0.01
实施例4:对具备降血脂功效植物甾醇复合营养素咀嚼片进行人群试验
设计方法:按照我国《保健品食品检验及评价技术规范——2003年》第一部分第四项人体试食规程,以及第二部分第二项辅助降血脂功能检验方法——人体试食试验中的规定内容。试验设计采用随机双盲方案,设定对照组和低、中、高剂量组,其中各组植物甾醇剂量分别为0.00、1.04g/d、1.56g/d和2.08g/d。通过测定受试者干预前、干预1个月和3个月后的血脂指标变化,考察对降脂功效的影响。
受试样本纳入及排除标准:招募TC或TG指标分别不小于5.18mmol/L和1.7mmol/L的受试人员181名,排除其中含有干扰试验结果指标的因素,例如合并糖尿病、慢性感染性疾病、严重肝肾功能衰竭、严重心功能衰竭、自身免疫性疾病及恶性肿瘤等。最终筛选共141名受试者,最终纳入分析的各组样本数分别为:对照组22人、低剂量组30人、中剂量组19人和高剂量组24人。
观察指标及测定方法:根据《中国成人血脂异常防治指南(2007版)》诊断标准,选定TC、TG、LDL和HDL作为干预效果指标。受试者干预前进行体格检查,以此作为干预效果评价的基准,受试者服用植物甾醇复合营养素咀嚼片1个月和3个月后,分别对其进行干预中期和终期体格检查,通过TC、TG、LDL和HDL指标的变化评定干预效果,其TC、TG、LDL指标的降低,以及HDL指标的升高都表明存在正面的干预效果;反之则提示负面的干预效果。
试验结果:
1)当试服植物甾醇复合营养素咀嚼片,低剂量3个月后及中、高剂量1个月后的LDL指标显著降低,与对照组相比差异具有统计学意义(p<0.05),每天摄入植物甾醇1.04g的低剂量植物甾醇复合营养素咀嚼片能在干预1个月后降低LDL值3.7%,而干预3个月后可降低13.6%。
2)增加植物甾醇复合营养素咀嚼片摄入量能更显著降低LDL值,干预1个月后LDL值降低高达35.2%。
3)低、高剂量组HDL指标也显著提高,与对照组相比差异具统计学意义(p<0.05)。
实施例5:植物甾醇复合营养素咀嚼片血脂异常人群试服个体数据
32岁男性,植物甾醇复合营养素咀嚼片,剂量以植物甾醇计,480mg/天,持续6周。
实施例6:植物甾醇复合营养素咀嚼片血脂异常人群试服个体数据
72岁女性,植物甾醇复合营养素咀嚼片,剂量以植物甾醇计,960mg/天,持续8周。
实施例7:植物甾醇复合营养素咀嚼片血脂异常人群试服个体数据
58女性,植物甾醇复合营养素咀嚼片,剂量以植物甾醇计,前8周960mg/天,后四周480mg/天,共持续12周。
实施例8
分别使用本发明的辅料组合物和现有技术的辅料组合物来制备含有植物甾醇的咀嚼片。根据本发明的辅料组合物优选为异麦芽酮糖醇:微晶纤维素:炒麦芽=19-21:18-22:1;现有技术的辅料组合物不包括炒麦芽。
将上述辅料组合物与包括植物甾醇的其他原料混合,其中,本申请的辅料组合物可以添加高达25%的植物甾醇,而对于现有技术的辅料组合物,植物甾醇的添加量仅能够达到15%,当高于该添加量时,连续生产10分钟,压片机个别冲头开始出现轻微粘冲的情况;连续生产20分钟,压片机大部分冲头都出现粘冲,影响咀嚼片的外观,需要清理冲头;连续生产30分钟,所有冲头粘冲严重,无法压片,需要清理冲头。
通过与实施例1或实施例2的相同的制备方法生产咀嚼片,记录两次停止生产以清理粘冲物质的间隔时间,结果见下表。
本发明的实施方式并不受上述实施例的限制,其他的任何未背离本发明的精神实质与原理下所作的改变、修饰、替代、组合、简化,均应为等效的置换方式,都包含在本发明的保护范围之内。
Claims (7)
1.一种植物甾醇咀嚼片,其包含辅料组合物,所述辅料组合物以16-24:18-26:0.5-2.0的比例包含异麦芽酮糖醇、微晶纤维素和炒麦芽。
2.根据权利要求1所述的植物甾醇咀嚼片,其还包含植物甾醇、大豆肽。
3.根据权利要求1所述的植物甾醇咀嚼片,其还包含:玉米低聚肽、磷脂、γ-氨基丁酸和纳豆粉。
4.根据权利要求2或3所述的植物甾醇咀嚼片,其中,所述植物甾醇:所述大豆肽:所述玉米低聚肽:所述磷脂:所述γ-氨基丁酸:所述纳豆粉=10-22:1-8:1-8:1-8:1:0.2-6.6。
5.根据权利要求1所述的植物甾醇咀嚼片,其中,植物甾醇的添加量达到16%~25%/片咀嚼片。
6.根据权利要求1所述的植物甾醇咀嚼片,其还包含甘露醇、硬脂酸镁和三氯蔗糖。
7.一种用于制备根据权利要求1-6中任一项权利要求所述的植物甾醇咀嚼片的方法,其包括以下步骤:
1):所有原辅料分别过60目筛;
2):将过筛后的植物甾醇、大豆肽、玉米低聚肽、γ-氨基丁酸、麦芽糊精、D-甘露糖醇、微晶纤维素、异麦芽酮糖醇、炒麦芽粉的几种或全部按照比例置于湿法制粒机中混合均匀,以水为粘合剂制粒;
3):用沸腾干燥机烘干,先烘半干,再用16目筛制粒;
4):制好的半干颗粒再用沸腾干燥机烘干,水分控制在4.0%~4.5%,再用20目筛整粒,控制颗粒与粉的比例为1:1;
5):将前述干颗粒与纳豆粉、硬脂酸镁、三氯蔗糖中的几种或全部置于混合机内,混合均匀;
6):用旋转式压片机压片。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201911332320.6A CN111035620B (zh) | 2019-12-25 | 2019-12-25 | 一种辅料组合物、植物甾醇复合营养素咀嚼片及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201911332320.6A CN111035620B (zh) | 2019-12-25 | 2019-12-25 | 一种辅料组合物、植物甾醇复合营养素咀嚼片及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN111035620A CN111035620A (zh) | 2020-04-21 |
CN111035620B true CN111035620B (zh) | 2021-08-27 |
Family
ID=70238165
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201911332320.6A Active CN111035620B (zh) | 2019-12-25 | 2019-12-25 | 一种辅料组合物、植物甾醇复合营养素咀嚼片及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN111035620B (zh) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110897164A (zh) * | 2019-12-26 | 2020-03-24 | 广州莱可福生物科技有限公司 | 一种含有植物甾醇的组合物及其改善血糖的用途 |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2006054627A1 (ja) * | 2004-11-17 | 2008-05-29 | 三栄源エフ・エフ・アイ株式会社 | 植物ステロール類含有組成物とその製造方法 |
CN102143692A (zh) * | 2008-09-04 | 2011-08-03 | 卡吉尔公司 | 赤藓醇的压片 |
CN103519055A (zh) * | 2013-10-15 | 2014-01-22 | 陕西科技大学 | 一种荞麦膳食纤维咀嚼片的制备方法 |
US20190201345A1 (en) * | 2016-06-28 | 2019-07-04 | Japan Antivirus Res. Inst., Ltd. | Excipient and tablet |
CN106617072A (zh) * | 2016-12-20 | 2017-05-10 | 广州莱可福生物科技有限公司 | 一种植物甾醇复合降脂组方及其片剂制备方法 |
-
2019
- 2019-12-25 CN CN201911332320.6A patent/CN111035620B/zh active Active
Also Published As
Publication number | Publication date |
---|---|
CN111035620A (zh) | 2020-04-21 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP6271571B2 (ja) | 腸内微生物叢の平衡を保つための組成物、該組成物の製法、および、該組成物の利用 | |
KR101464337B1 (ko) | 고욤나무 추출물을 유효성분으로 함유하는 항비만용 조성물 | |
KR101523812B1 (ko) | 율초 추출물을 유효성분으로 함유하는 대사성 질환 예방 및 치료용 조성물 | |
JP2008174539A (ja) | 紫色の馬鈴薯を使用した肥満患者用の健康機能食品 | |
JP2012051940A (ja) | ビワ葉抽出物を含有する飲食品及び医薬品 | |
JP2003342185A (ja) | リパーゼ活性阻害剤 | |
JP2004091464A (ja) | 肥満抑制剤 | |
CN111035620B (zh) | 一种辅料组合物、植物甾醇复合营养素咀嚼片及其制备方法 | |
EP1583547B1 (en) | Anti-obesity ingredients from medicinal plants and their composition | |
CN107551001B (zh) | 一种用于防治酒精性肝损伤的中药复合物及其制法 | |
EP1656943A1 (en) | Extract from plant of japanese parsley family and process for producing the same | |
KR20160141027A (ko) | 아위버섯 물 추출물을 유효성분으로 함유하는 대사성질환의 예방 및 치료용 약학적 조성물 또는 건강기능성식품 | |
CN108420890B (zh) | 一种具有降血脂作用的组合物及其制备方法 | |
CN113350453B (zh) | 用于升高hdl-c的组合物 | |
JP3204348B2 (ja) | 動脈硬化抑制剤及びこれを含む食品又は医薬 | |
JP3142192B2 (ja) | 血中脂質改善剤及びこれを含有する組成物 | |
KR101811210B1 (ko) | 마가목 열매 추출물을 유효성분으로 하는 당뇨 질환 치료, 개선 또는 예방용 조성물 | |
JP3897262B2 (ja) | キヌア皮含有組成物及び食品 | |
US20070092587A1 (en) | Extract from plant of japanese parsley family and process for producing the same | |
KR100473529B1 (ko) | 순기산 생약 복합제 추출물을 유효성분으로 함유하는당뇨병 예방 및 치료용 조성물 | |
CN110404029B (zh) | 一种具有降血糖功效的组合物及其制备方法和应用 | |
KR20190094572A (ko) | 항당뇨용 조성물 및 이의 제조 방법 | |
KR102200260B1 (ko) | 두메부추 및 오이풀 추출물의 제조방법 및 상기 추출물을 유효성분으로 포함하는 비만 및 비만으로부터 유도된 대사증후군 개선용 조성물 | |
WO2021112263A1 (ja) | アディポネクチン産生促進剤 | |
EP3620166B1 (en) | Composition for anti-obesity comprising the pulverized material of odontella aurita as an active ingredient |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
GR01 | Patent grant | ||
GR01 | Patent grant |