CN115299609A - 一种具有改善睡眠功能的组合物及其制备方法 - Google Patents
一种具有改善睡眠功能的组合物及其制备方法 Download PDFInfo
- Publication number
- CN115299609A CN115299609A CN202210275867.2A CN202210275867A CN115299609A CN 115299609 A CN115299609 A CN 115299609A CN 202210275867 A CN202210275867 A CN 202210275867A CN 115299609 A CN115299609 A CN 115299609A
- Authority
- CN
- China
- Prior art keywords
- extract
- parts
- composition
- sleep
- lycium ruthenicum
- 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.)
- Pending
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 40
- 230000007958 sleep Effects 0.000 title claims abstract description 25
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000000284 extract Substances 0.000 claims abstract description 50
- 241000169546 Lycium ruthenicum Species 0.000 claims abstract description 30
- 239000000843 powder Substances 0.000 claims abstract description 15
- 229940029079 rose petal extract Drugs 0.000 claims abstract description 13
- 241000186000 Bifidobacterium Species 0.000 claims abstract description 12
- 241000220317 Rosa Species 0.000 claims abstract description 12
- 229940104640 chinese yam extract Drugs 0.000 claims abstract description 12
- 210000000582 semen Anatomy 0.000 claims abstract description 8
- 235000004879 dioscorea Nutrition 0.000 claims abstract 2
- 241000186015 Bifidobacterium longum subsp. infantis Species 0.000 claims description 14
- 229940004120 bifidobacterium infantis Drugs 0.000 claims description 14
- 235000002722 Dioscorea batatas Nutrition 0.000 claims description 11
- 235000006536 Dioscorea esculenta Nutrition 0.000 claims description 11
- 240000001811 Dioscorea oppositifolia Species 0.000 claims description 11
- 235000003416 Dioscorea oppositifolia Nutrition 0.000 claims description 11
- 239000000463 material Substances 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 7
- 241000628997 Flos Species 0.000 claims description 5
- 235000009508 confectionery Nutrition 0.000 claims description 4
- 239000008187 granular material Substances 0.000 claims description 4
- 239000007902 hard capsule Substances 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 239000007901 soft capsule Substances 0.000 claims description 4
- 239000003826 tablet Substances 0.000 claims description 4
- 235000000664 Rosa chinensis Nutrition 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 238000003809 water extraction Methods 0.000 claims description 3
- 238000009835 boiling Methods 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- 239000003085 diluting agent Substances 0.000 claims description 2
- 235000013399 edible fruits Nutrition 0.000 claims description 2
- 238000001704 evaporation Methods 0.000 claims description 2
- 239000000945 filler Substances 0.000 claims description 2
- 235000003599 food sweetener Nutrition 0.000 claims description 2
- 238000004108 freeze drying Methods 0.000 claims description 2
- 239000000314 lubricant Substances 0.000 claims description 2
- 239000000049 pigment Substances 0.000 claims description 2
- 239000004014 plasticizer Substances 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- 230000002335 preservative effect Effects 0.000 claims description 2
- 238000002791 soaking Methods 0.000 claims description 2
- 239000000375 suspending agent Substances 0.000 claims description 2
- 239000003765 sweetening agent Substances 0.000 claims description 2
- 240000008254 Rosa chinensis Species 0.000 claims 1
- 239000006186 oral dosage form Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 14
- 230000003860 sleep quality Effects 0.000 abstract description 14
- 239000003814 drug Substances 0.000 abstract description 10
- 229940079593 drug Drugs 0.000 abstract description 4
- 210000003734 kidney Anatomy 0.000 abstract description 4
- 210000004556 brain Anatomy 0.000 abstract description 3
- LQIAZOCLNBBZQK-UHFFFAOYSA-N 1-(1,2-Diphosphanylethyl)pyrrolidin-2-one Chemical compound PCC(P)N1CCCC1=O LQIAZOCLNBBZQK-UHFFFAOYSA-N 0.000 abstract description 2
- 230000008901 benefit Effects 0.000 abstract description 2
- 239000008280 blood Substances 0.000 abstract description 2
- 210000004369 blood Anatomy 0.000 abstract description 2
- 150000001875 compounds Chemical class 0.000 abstract description 2
- 230000006872 improvement Effects 0.000 abstract description 2
- 210000004185 liver Anatomy 0.000 abstract description 2
- 210000005036 nerve Anatomy 0.000 abstract description 2
- 230000009044 synergistic interaction Effects 0.000 abstract description 2
- 230000002936 tranquilizing effect Effects 0.000 abstract description 2
- 235000017784 Mespilus germanica Nutrition 0.000 abstract 1
- 244000182216 Mimusops elengi Species 0.000 abstract 1
- 235000000560 Mimusops elengi Nutrition 0.000 abstract 1
- 235000007837 Vangueria infausta Nutrition 0.000 abstract 1
- 230000004377 improving vision Effects 0.000 abstract 1
- 230000000052 comparative effect Effects 0.000 description 14
- BTCSSZJGUNDROE-UHFFFAOYSA-N gamma-aminobutyric acid Chemical compound NCCCC(O)=O BTCSSZJGUNDROE-UHFFFAOYSA-N 0.000 description 14
- 238000002474 experimental method Methods 0.000 description 13
- 241001465754 Metazoa Species 0.000 description 10
- OGNSCSPNOLGXSM-UHFFFAOYSA-N (+/-)-DABA Natural products NCCC(N)C(O)=O OGNSCSPNOLGXSM-UHFFFAOYSA-N 0.000 description 7
- 241000699670 Mus sp. Species 0.000 description 7
- 229960003692 gamma aminobutyric acid Drugs 0.000 description 7
- 241000699666 Mus <mouse, genus> Species 0.000 description 6
- QGMRQYFBGABWDR-UHFFFAOYSA-M Pentobarbital sodium Chemical compound [Na+].CCCC(C)C1(CC)C(=O)NC(=O)[N-]C1=O QGMRQYFBGABWDR-UHFFFAOYSA-M 0.000 description 5
- 235000013305 food Nutrition 0.000 description 5
- 230000004620 sleep latency Effects 0.000 description 5
- 230000009286 beneficial effect Effects 0.000 description 4
- 230000008034 disappearance Effects 0.000 description 4
- 230000004622 sleep time Effects 0.000 description 4
- 230000036578 sleeping time Effects 0.000 description 4
- 229960001412 pentobarbital Drugs 0.000 description 3
- 239000006041 probiotic Substances 0.000 description 3
- 235000018291 probiotics Nutrition 0.000 description 3
- 230000028527 righting reflex Effects 0.000 description 3
- RGHFKWPGWBFQLN-UHFFFAOYSA-M sodium;5,5-diethylpyrimidin-3-ide-2,4,6-trione Chemical compound [Na+].CCC1(CC)C([O-])=NC(=O)NC1=O RGHFKWPGWBFQLN-UHFFFAOYSA-M 0.000 description 3
- 230000002195 synergetic effect Effects 0.000 description 3
- 241000196324 Embryophyta Species 0.000 description 2
- YJPIGAIKUZMOQA-UHFFFAOYSA-N Melatonin Natural products COC1=CC=C2N(C(C)=O)C=C(CCN)C2=C1 YJPIGAIKUZMOQA-UHFFFAOYSA-N 0.000 description 2
- 229960000796 barbital sodium Drugs 0.000 description 2
- FTOAOBMCPZCFFF-UHFFFAOYSA-N barbitone sodium Natural products CCC1(CC)C(=O)NC(=O)NC1=O FTOAOBMCPZCFFF-UHFFFAOYSA-N 0.000 description 2
- 230000007613 environmental effect Effects 0.000 description 2
- 230000003203 everyday effect Effects 0.000 description 2
- 238000003304 gavage Methods 0.000 description 2
- 230000000147 hypnotic effect Effects 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- DRLFMBDRBRZALE-UHFFFAOYSA-N melatonin Chemical compound COC1=CC=C2NC=C(CCNC(C)=O)C2=C1 DRLFMBDRBRZALE-UHFFFAOYSA-N 0.000 description 2
- 229960003987 melatonin Drugs 0.000 description 2
- 244000005700 microbiome Species 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 229960002275 pentobarbital sodium Drugs 0.000 description 2
- 230000002035 prolonged effect Effects 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 230000028327 secretion Effects 0.000 description 2
- 208000019116 sleep disease Diseases 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 238000011746 C57BL/6J (JAX™ mouse strain) Methods 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 206010011985 Decubitus ulcer Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 206010062519 Poor quality sleep Diseases 0.000 description 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 1
- 208000032140 Sleepiness Diseases 0.000 description 1
- 206010041349 Somnolence Diseases 0.000 description 1
- 210000000683 abdominal cavity Anatomy 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 229940125717 barbiturate Drugs 0.000 description 1
- HNYOPLTXPVRDBG-UHFFFAOYSA-N barbituric acid Chemical compound O=C1CC(=O)NC(=O)N1 HNYOPLTXPVRDBG-UHFFFAOYSA-N 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000027288 circadian rhythm Effects 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 235000015872 dietary supplement Nutrition 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000035622 drinking Effects 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 230000009977 dual effect Effects 0.000 description 1
- 235000018927 edible plant Nutrition 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000004438 eyesight Effects 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 206010022437 insomnia Diseases 0.000 description 1
- 239000007928 intraperitoneal injection Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000000419 plant extract Substances 0.000 description 1
- 230000000529 probiotic effect Effects 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 238000010791 quenching Methods 0.000 description 1
- 230000000171 quenching effect Effects 0.000 description 1
- 230000011514 reflex Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 210000004994 reproductive system Anatomy 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 208000020685 sleep-wake disease Diseases 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
Classifications
-
- 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
-
- 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
- A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/745—Bifidobacteria
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/11—Pteridophyta or Filicophyta (ferns)
- A61K36/12—Filicopsida or Pteridopsida
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
- A61K36/725—Ziziphus, e.g. jujube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/738—Rosa (rose)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
-
- 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
-
- 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
- A23V2400/00—Lactic or propionic acid bacteria
- A23V2400/51—Bifidobacterium
- A23V2400/529—Infantis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Chemical & Material Sciences (AREA)
- Mycology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Medical Informatics (AREA)
- Alternative & Traditional Medicine (AREA)
- Nutrition Science (AREA)
- Polymers & Plastics (AREA)
- Food Science & Technology (AREA)
- Neurosurgery (AREA)
- Anesthesiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Physiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种具有改善睡眠功能的组合物，包括如下重量份的(1)和(2)组分：(1)黑枸杞提取物2～5份和/或酸枣仁提取物2～5份和/或山药提取物2～5份和/或玫瑰小花瓣提取物1～5份；(2)婴儿双岐杆菌干粉0.05‑0.5份。本发明基于中医的整体理念，进行科学配伍，能有效改善睡眠质量，各有效成分之间能够发挥协同增效作用，从而获得一种改善睡眠功能的组合物配方。在该组合物中，枸杞，清肝明目、补肾助眠；酸枣仁用于养心安神催眠；山药养血、补脑、益肾；玫瑰助安神，诸药合用，可以充分发挥复方制剂的整体调节优势，具有较好的改善睡眠作用，疗效确切。
Description
技术领域
本发明属于特殊医疗食品技术领域，具体涉及一种具有改善睡眠功能的组合物及其制备方法。
背景技术
睡眠对大脑的正常运作至关重要。然而，近年来，睡眠障碍的发生越加频繁。睡眠质量差而导致脸色枯黄、反应迟钝、记忆力衰退，不仅影响生活和工作，而且会引发糖尿病、心脑血管等多种慢性病。而依赖于安眠药、褪黑素的疗法无异于饮鸩止渴，其副作用令人无法忽视，还会使身体产生依赖性，直接抑制机体褪黑素的正常合成与分泌，从而导致睡眠功能紊乱。虽然发现了许多改善睡眠质量的中药提取物，但由于种种原因，如毒副作用等问题，目前还没有针对改善睡眠质量的公认食补、药补的方案。
发明内容
为了解决现有技术中的不足，本发明的目的是在于提供一种具有改善睡眠功能的组合物及其制备方法。益生菌是一类对宿主有益的活性微生物，是定植于人体肠道、生殖系统内，能产生确切健康功效从而改善宿主微生态平衡、发挥有益作用的活性有益微生物的总称。其中，婴儿双岐杆菌具有显著的抗衰老、抗氧化、复活机体免疫功能、调整内分泌等效果。本发明发现婴儿双岐杆菌联合黑枸杞、酸枣仁、山药、玫瑰小花瓣具有显著的改善睡眠质量的功效。具体技术方案如下：
本发明第一方面提供一种具有改善睡眠功能的组合物，包括如下重量份的(1)和(2)组分：
(1)黑枸杞提取物2～5份和/或酸枣仁提取物2～5份和/或山药提取物2～5份和/或玫瑰小花瓣提取物1～5份；
(2)婴儿双岐杆菌干粉0.05-0.5份。
优选地，所述组合物包括如下重量份的组分：
黑枸杞提取物2～5份、酸枣仁提取物2～5份、山药提取物2～5份、玫瑰小花瓣提取物1～5份、婴儿双岐杆菌干粉0.05-0.5份。
进一步地，所述婴儿双岐杆菌干粉中的活菌数为1×109-1010CFU/g。
进一步地，所述组合物还包括辅料0.1～4份。
进一步地，所述辅料包括水果粉0％～30％、食用香精0％～30％、甜味剂0％～30％、酸味剂0％～30％、填充剂0％～30％、润滑剂0％～30％、防腐剂0％～30％、助悬剂0％～30％、食用色素0％～30％、稀释剂0％～30％％、增塑剂0％～30％。
进一步地，所述黑枸杞提取物、酸枣仁提取物、山药提取物和玫瑰小花瓣提取物为黑枸杞、酸枣仁、山药和玫瑰小花瓣经水提、煎煮、干燥后的粉末。
进一步地，所述黑枸杞提取物、酸枣仁提取物、山药提取物或玫瑰小花瓣提取物的制备方法为：向黑枸杞、酸枣仁、山药或玫瑰小花瓣中加入水浸泡0.5-1h后，在常压沸水提取2-3次，每次1-2h，然后减压旋转蒸干浓缩成浸膏，冷冻干燥，即得黑枸杞提取物、酸枣仁提取物、山药提取物或玫瑰小花瓣提取物；
优选地，所述黑枸杞、酸枣仁、山药或玫瑰小花瓣与水的质量体积比为1:8。
进一步地，所述组合物的剂型为口服剂；
优选地，所述口服剂包括粉剂、颗粒剂、片剂、硬胶囊剂、软胶囊、口服液和软糖。
本发明第二方面提供一种所述的具有改善睡眠功能的组合物的制备方法，将黑枸杞提取物1～5份和/或酸枣仁提取物2～5份和/或山药提取物2～5份和/或玫瑰小花瓣提取物1～5份与婴儿双岐杆菌0.05-0.5份进行混料，加入辅料，制成口服剂。
进一步地，所述口服剂包括粉剂、颗粒剂、片剂、硬胶囊剂、软胶囊、口服液和软糖。
本发明的有益效果为：
本发明基于中医的整体理念，进行科学配伍，提供一种具有改善睡眠功能的组合物，婴儿双岐杆菌联合黑枸杞、酸枣仁、山药、玫瑰小花瓣等形成的组合物，各有效成分之间能够发挥协同增效作用，其中枸杞，清肝明目、补肾助眠；酸枣仁用于养心安神催眠；山药养血、补脑、益肾；玫瑰助安神，诸药合用，可以充分发挥复方制剂的整体调节优势，具有较好的改善睡眠作用，疗效确切。同时，婴儿双岐杆菌为益生菌，黑枸杞、酸枣仁、山药、玫瑰小花瓣为“药食两用”的食品材料，本发明提供的组合物既改善睡眠质量，也具有更高的安全性。
具体实施方式
为了更清楚地理解本发明，现参照下列实施例进一步描述本发明。实施例仅用于解释而不以任何方式限制本发明。实施例中，各原始试剂材料均可商购获得，未注明具体条件的实验方法为所属领域熟知的常规方法和常规条件，或按照仪器制造商所建议的条件。
实施例中所述黑枸杞提取物、酸枣仁提取物、山药提取物和玫瑰小花瓣提取物为黑枸杞、酸枣仁、山药和玫瑰小花瓣经水提、煎煮、干燥后的粉末。
具体地，所述黑枸杞提取物、酸枣仁提取物、山药提取物或玫瑰小花瓣提取物的制备方法为：向黑枸杞、酸枣仁、山药或玫瑰小花瓣中加入水(w/v,1:8)浸泡0.5h后，在常压沸水提取2次，每次1h，然后减压旋转蒸干浓缩成浸膏，冷冻干燥，即得黑枸杞提取物、酸枣仁提取物、山药提取物或玫瑰小花瓣提取物。
本发明实施例中小鼠分组及其饲养条件如下：
实验在C57BL/6J小鼠(22-25g)适应实验环境一周后进行。每12只小鼠随机分为一组。饲养条件：动物实验设施持续保持屏障环境标准。主要环境指标的控制范围：温度23.1±0.9℃。相对湿度52.8±3g。换气次数为10-20次/小时，光照明：暗＝12h：12h。由获得资格认证的人员进行饲养管理。每周2次更换消毒后的垫料和笼具，保持盒内环境清洁干燥；每日添加饲料和饮水，保持动物自由饮食活动。
每个实施例/对比例需将36只小鼠分为3个实验小组(1组进行直接睡眠实验，延长戊巴比妥钠睡眠时间实验；1组进行戊巴比妥钠阚下剂量催眠实验；1组进行巴比妥钠睡眠潜伏期实验)，每组12只小鼠。
本发明实施例中小鼠睡眠实验测试方法如下：
直接睡眠实验：末次灌胃后，观察是否出现睡眠现象。睡眠以翻正反射消失为指标。当小鼠置于背卧位时。能立即翻正身位，如超过60s不能翻正者.即认为翻正反射消失，进入睡眠。翻正反射恢复即为动物觉醒，翻正反射消失至恢复这段时间为动物睡眠时间，记录对照组与各剂量组入睡动物数及睡眠时间。
延长戊巴比妥钠睡眠时间实验：于末次灌胃15min后，给各组动物腹腔注射50mg·kg-1BW戊巴比妥钠，注射量为0.2mL/20g BW，以翻正反射消失为入睡判断标准，观察受试样品是否延长戊巴比妥钠睡眠时间。
巴比妥钠睡眠潜伏期实验：于末次灌胃15min后.给各组动物腹腔注射280mg·kg- 1BW巴比妥钠，注射量为0.2mL/20g BW，以翻正反射消失为指标，观察受试样品对巴比妥钠睡眠潜伏期的影响。
实施例1
本实施例提供一种改善睡眠质量的益生菌，将婴儿双岐杆菌5×109CFU(0.25g)加蒸馏水复溶，稀释至0.08×109-1010CFU/mL，每只小鼠灌胃量为10mL/kg，即人体等效剂量饲喂小鼠，每天灌胃1次。
实施例2
本实施例提供一种改善睡眠质量的组合物，包括：婴儿双岐杆菌5×109CFU(0.25g)，黑枸杞提取物3g；其他和实施例1保持一致，得到组合物。
实施例3
本实施例提供一种改善睡眠质量的组合物，包括：婴儿双岐杆菌5×109CFU(0.25g)，酸枣仁提取物3g；其他和实施例1保持一致，得到组合物。
实施例4
本实施例提供一种改善睡眠质量的组合物，包括：婴儿双岐杆菌5×109CFU(0.25g)，山药提取物3g；其他和实施例1保持一致，得到组合物。
实施例5
本实施例提供一种改善睡眠质量的组合物，包括：婴儿双岐杆菌5×109CFU(0.25g)，玫瑰小花瓣提取物3g；其他和实施例1保持一致，得到组合物。
实施例6
本实施例提供一种改善睡眠质量的组合物，包括：婴儿双岐杆菌5×109CFU(0.25g)，黑枸杞提取物3g、酸枣仁提取物3g、山药提取物3g、玫瑰小花瓣提取物3g；其他和实施例1保持一致，得到组合物。
对比例1
本对比例采用和实施例1用量相同的蒸馏水进行动物实验。
对比例2
本对比例采用和实施例1用量相同的γ-氨基丁酸(GABA)进行动物实验。
对比例3
本对比例采用和实施例2组合物用量相同的黑枸杞提取物进行动物实验。
对比例4
调整实施例2中婴儿双岐杆菌为γ-氨基丁酸(GABA)，采用包括GABA 0.25g和黑枸杞提取物3g的组合物进行动物实验。
实施例1-6和对比例1-4组合物进行小鼠睡眠实验测试方法。结果如表1所示。
表1实施例1-6、对比例1-4的测试结果
从上表可以看出，相比于空白组(对比例1)，婴儿双岐杆菌组(实施例1)小鼠的睡眠时间显著延长，入睡小鼠比例更多，即睡眠发生率更高，且睡眠潜伏期更短。婴儿双岐杆菌(实施例1)相比于GABA(对比例2)，具有相当水平的改善睡眠质量的效果。相比于婴儿双岐杆菌单方(实施例1)，婴儿双岐杆菌联合黑枸杞、酸枣仁、山药、玫瑰小花瓣“药食同源”的植物提取物进行组合后，能够发挥显著的改善睡眠质量的协同效应，极大地提高小鼠的睡眠时间、睡眠发生率，缩短睡眠潜伏期；而黑枸杞提取物单方(对比例3)和黑枸杞提取物联合γ-氨基丁酸组合物(对比例4)的协同效果并不显著，表明婴儿双岐杆菌与“药食同源”的植物能够发挥出特有的协同改善睡眠质量的效果。婴儿双岐杆菌联合黑枸杞、酸枣仁、山药、玫瑰小花瓣“药食同源”的植物(实施例6)，虽然小鼠睡眠时间并未显著延长，但睡眠发生率显著提高，睡眠潜伏率明显降低，表明该组合物可能靶向调节昼夜节律的平衡，避免夜间失眠和过度嗜睡。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (10)
1.一种具有改善睡眠功能的组合物，其特征在于，所述组合物包括如下重量份的(1)和(2)组分：
(1)黑枸杞提取物2～5份和/或酸枣仁提取物2～5份和/或山药提取物2～5份和/或玫瑰小花瓣提取物1～5份；
(2)婴儿双岐杆菌干粉0.05-0.5份。
2.根据权利要求1所述的组合物，其特征在于，所述组合物包括如下重量份的组分：
黑枸杞提取物2～5份、酸枣仁提取物2～5份、山药提取物2～5份、玫瑰小花瓣提取物1～5份、婴儿双岐杆菌干粉0.05-0.5份。
3.根据权利要求1或2所述的组合物，其特征在于，所述婴儿双岐杆菌干粉中的活菌数为1×109-1010CFU/g。
4.根据权利要求1或2所述的组合物，其特征在于，所述组合物还包括辅料0.1～4份。
5.根据权利要求4所述的组合物，其特征在于，所述辅料包括水果粉0％～30％、食用香精0％～30％、甜味剂0％～30％、酸味剂0％～30％、填充剂0％～30％、润滑剂0％～30％、防腐剂0％～30％、助悬剂0％～30％、食用色素0％～30％、稀释剂0％～30％％、增塑剂0％～30％。
6.根据权利要求1或2所述的组合物，其特征在于，所述黑枸杞提取物、酸枣仁提取物、山药提取物和玫瑰小花瓣提取物为黑枸杞、酸枣仁、山药和玫瑰小花瓣经水提、煎煮、干燥后的粉末。
7.根据权利要求1或2所述的组合物，其特征在于，所述黑枸杞提取物、酸枣仁提取物、山药提取物或玫瑰小花瓣提取物的制备方法为：向黑枸杞、酸枣仁、山药或玫瑰小花瓣中加入水浸泡0.5-1h后，在常压沸水提取2-3次，每次1-2h，然后减压旋转蒸干浓缩成浸膏，冷冻干燥，即得黑枸杞提取物、酸枣仁提取物、山药提取物或玫瑰小花瓣提取物；
优选地，所述黑枸杞、酸枣仁、山药或玫瑰小花瓣与水的质量体积比为1:8。
8.根据权利要求1或2所述的组合物，其特征在于，所述组合物的剂型为口服剂；
优选地，所述口服剂包括粉剂、颗粒剂、片剂、硬胶囊剂、软胶囊、口服液和软糖。
9.一种权利要求1所述的组合物的制备方法，其特征在于，将黑枸杞提取物1～5份和/或酸枣仁提取物2～5份和/或山药提取物2～5份和/或玫瑰小花瓣提取物1～5份与婴儿双岐杆菌0.05-0.5份进行混料，加入辅料，制成口服剂。
10.根据权利要求9所述的制备方法，其特征在于，所述口服剂包括粉剂、颗粒剂、片剂、硬胶囊剂、软胶囊、口服液和软糖。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210275867.2A CN115299609A (zh) | 2022-03-21 | 2022-03-21 | 一种具有改善睡眠功能的组合物及其制备方法 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210275867.2A CN115299609A (zh) | 2022-03-21 | 2022-03-21 | 一种具有改善睡眠功能的组合物及其制备方法 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115299609A true CN115299609A (zh) | 2022-11-08 |
Family
ID=83855706
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210275867.2A Pending CN115299609A (zh) | 2022-03-21 | 2022-03-21 | 一种具有改善睡眠功能的组合物及其制备方法 |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN115299609A (zh) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102960447A (zh) * | 2008-11-03 | 2013-03-13 | 雀巢产品技术援助有限公司 | 包含益生菌并改善睡眠模式的营养组合物 |
| CN103784611A (zh) * | 2014-01-23 | 2014-05-14 | 云南白药天颐茶品有限公司 | 一种具有改善睡眠帮助缓解压力的组合物及其应用 |
| CN104187613A (zh) * | 2014-07-29 | 2014-12-10 | 胡安然 | 失眠全营养配方食品 |
| CN108671135A (zh) * | 2018-08-01 | 2018-10-19 | 泰安大凡神农生物有限公司 | 一种调理失眠和抑郁的中药益生菌复合物 |
-
2022
- 2022-03-21 CN CN202210275867.2A patent/CN115299609A/zh active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102960447A (zh) * | 2008-11-03 | 2013-03-13 | 雀巢产品技术援助有限公司 | 包含益生菌并改善睡眠模式的营养组合物 |
| CN103784611A (zh) * | 2014-01-23 | 2014-05-14 | 云南白药天颐茶品有限公司 | 一种具有改善睡眠帮助缓解压力的组合物及其应用 |
| CN104187613A (zh) * | 2014-07-29 | 2014-12-10 | 胡安然 | 失眠全营养配方食品 |
| CN108671135A (zh) * | 2018-08-01 | 2018-10-19 | 泰安大凡神农生物有限公司 | 一种调理失眠和抑郁的中药益生菌复合物 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103784611B (zh) | 一种具有改善睡眠帮助缓解压力的组合物及其应用 | |
| CN110934914A (zh) | 一种具有保肝功能的组合物及其制备方法和应用 | |
| CN110433259A (zh) | 一种干预气郁体质的中药组合物、破壁组合物及其制备方法 | |
| CN113559130A (zh) | 一种酸枣仁枯草芽孢杆菌共发酵产物及其制备方法和应用 | |
| KR101861784B1 (ko) | 한약재 추출물（ｃｊｓ０３）을 함유하는 불면증 개선, 예방 또는 치료용 조성물 | |
| CN114246878B (zh) | 一种中药提取物组合物及其制备方法和应用 | |
| CN105519816B (zh) | 一种提高蛋鸡抗应激能力的添加剂 | |
| KR101910317B1 (ko) | 택란추출물을 유효성분으로 포함하는 비만 예방, 치료, 또는 개선용 조성물 | |
| CN105433382B (zh) | 一种玛咖组合物及其制备方法和用途 | |
| CN104644734B (zh) | 一种治疗ⅱ型糖尿病及其并发症的药物 | |
| KR101910013B1 (ko) | 한약재 추출물（ｓｏｃｇ）을 함유하는 통증의 개선, 예방 또는 치료용 조성물 | |
| CN115299609A (zh) | 一种具有改善睡眠功能的组合物及其制备方法 | |
| CN115886252A (zh) | 一种促进睡眠和调节抑郁情绪的食品组合物及其制备方法 | |
| KR101687558B1 (ko) | 천연재료 추출물을 유효성분으로 하는 변비 및 숙변 개선용 조성물 및 그의 제조방법 | |
| CN111616357B (zh) | 基于药食同源的gaba补脾安神组合物、制剂及其应用 | |
| TWI784169B (zh) | 夜間頻尿之預防或改善劑 | |
| CN114557446A (zh) | 二氢杨梅素作为活性成分在睡眠障碍中的应用 | |
| CN114009773A (zh) | 一种具有改善睡眠作用的组合物及其制备方法和用途 | |
| KR101568044B1 (ko) | 불안 및 스트레스 해소용 조성물 | |
| CN101584750B (zh) | 一种无花果复方制剂 | |
| CN110710672A (zh) | 一种天然植物活性钙制剂及其制备方法 | |
| CN110063977A (zh) | 一种党参、沙棘复合冲剂及其应用 | |
| KR102687132B1 (ko) | 질경이 추출물을 유효성분으로 함유하는 통증의 개선, 예방 또는 치료용 조성물 | |
| CN114668148B (zh) | 具有安神助眠功效的保健组合物及其制备方法、保健品和应用 | |
| KR101457442B1 (ko) | 감마오리자놀을 유효성분으로 하는 히스타민 수용체 길항제 조성물 |
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 |