WO2022120906A1 - 一种具有抗焦虑作用的中药复方组合物及其制备方法与应用 - Google Patents
一种具有抗焦虑作用的中药复方组合物及其制备方法与应用 Download PDFInfo
- Publication number
- WO2022120906A1 WO2022120906A1 PCT/CN2020/136657 CN2020136657W WO2022120906A1 WO 2022120906 A1 WO2022120906 A1 WO 2022120906A1 CN 2020136657 W CN2020136657 W CN 2020136657W WO 2022120906 A1 WO2022120906 A1 WO 2022120906A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- chinese medicine
- traditional chinese
- compound composition
- medicine compound
- extract
- Prior art date
Links
- 239000003814 drug Substances 0.000 title claims abstract description 95
- 150000001875 compounds Chemical class 0.000 title claims abstract description 63
- 239000000203 mixture Substances 0.000 title claims abstract description 61
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- 230000000949 anxiolytic effect Effects 0.000 title claims abstract description 16
- 239000000284 extract Substances 0.000 claims abstract description 58
- 235000006484 Paeonia officinalis Nutrition 0.000 claims abstract description 8
- 235000013402 health food Nutrition 0.000 claims abstract description 7
- 235000015872 dietary supplement Nutrition 0.000 claims abstract description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 40
- 239000000463 material Substances 0.000 claims description 29
- 238000000605 extraction Methods 0.000 claims description 21
- 230000000049 anti-anxiety effect Effects 0.000 claims description 20
- 244000236658 Paeonia lactiflora Species 0.000 claims description 19
- 235000008598 Paeonia lactiflora Nutrition 0.000 claims description 19
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- 238000010992 reflux Methods 0.000 claims description 16
- 239000008213 purified water Substances 0.000 claims description 10
- 235000010643 Leucaena leucocephala Nutrition 0.000 claims description 7
- 241000736199 Paeonia Species 0.000 claims description 7
- 238000001035 drying Methods 0.000 claims description 7
- 240000007472 Leucaena leucocephala Species 0.000 claims description 6
- 239000008187 granular material Substances 0.000 claims description 5
- 238000000034 method Methods 0.000 claims description 5
- 239000002775 capsule Substances 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 4
- 239000002994 raw material Substances 0.000 claims description 4
- 238000007873 sieving Methods 0.000 claims description 4
- 239000003826 tablet Substances 0.000 claims description 4
- 239000002552 dosage form Substances 0.000 claims description 3
- 238000002156 mixing Methods 0.000 claims description 3
- 239000002904 solvent Substances 0.000 claims description 3
- 239000011347 resin Substances 0.000 claims description 2
- 229920005989 resin Polymers 0.000 claims description 2
- 240000001972 Gardenia jasminoides Species 0.000 claims 2
- 238000000746 purification Methods 0.000 claims 1
- 208000019901 Anxiety disease Diseases 0.000 abstract description 16
- 240000007185 Albizia julibrissin Species 0.000 abstract description 11
- 235000011468 Albizia julibrissin Nutrition 0.000 abstract description 11
- 230000001737 promoting effect Effects 0.000 abstract description 7
- 230000036506 anxiety Effects 0.000 abstract description 6
- 230000004630 mental health Effects 0.000 abstract description 6
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 abstract description 4
- 206010022437 insomnia Diseases 0.000 abstract description 4
- 238000013329 compounding Methods 0.000 abstract description 2
- 206010001497 Agitation Diseases 0.000 abstract 1
- 244000170916 Paeonia officinalis Species 0.000 abstract 1
- 238000013019 agitation Methods 0.000 abstract 1
- 239000005417 food ingredient Substances 0.000 abstract 1
- 231100000957 no side effect Toxicity 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 23
- 241000699670 Mus sp. Species 0.000 description 21
- 244000111489 Gardenia augusta Species 0.000 description 20
- 238000002474 experimental method Methods 0.000 description 17
- 239000000843 powder Substances 0.000 description 15
- 229940079593 drug Drugs 0.000 description 14
- 239000008280 blood Substances 0.000 description 10
- 210000004369 blood Anatomy 0.000 description 10
- 208000002193 Pain Diseases 0.000 description 8
- 239000012141 concentrate Substances 0.000 description 8
- 238000003304 gavage Methods 0.000 description 7
- 241001465754 Metazoa Species 0.000 description 6
- 239000008367 deionised water Substances 0.000 description 6
- 229910021641 deionized water Inorganic materials 0.000 description 6
- 230000006870 function Effects 0.000 description 6
- 241000699666 Mus <mouse, genus> Species 0.000 description 5
- 241000220433 Albizia Species 0.000 description 4
- 235000011438 Albizia odoratissima Nutrition 0.000 description 4
- 244000184734 Pyrus japonica Species 0.000 description 4
- AAOVKJBEBIDNHE-UHFFFAOYSA-N diazepam Chemical compound N=1CC(=O)N(C)C2=CC=C(Cl)C=C2C=1C1=CC=CC=C1 AAOVKJBEBIDNHE-UHFFFAOYSA-N 0.000 description 4
- 210000004185 liver Anatomy 0.000 description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- 230000035900 sweating Effects 0.000 description 4
- 231100000331 toxic Toxicity 0.000 description 4
- 230000002588 toxic effect Effects 0.000 description 4
- 230000006399 behavior Effects 0.000 description 3
- 238000001816 cooling Methods 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- -1 purify Substances 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 206010067484 Adverse reaction Diseases 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- 230000006838 adverse reaction Effects 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 208000002173 dizziness Diseases 0.000 description 2
- 208000001780 epistaxis Diseases 0.000 description 2
- 241000411851 herbal medicine Species 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 235000019359 magnesium stearate Nutrition 0.000 description 2
- 230000005906 menstruation Effects 0.000 description 2
- 230000003340 mental effect Effects 0.000 description 2
- 208000019906 panic disease Diseases 0.000 description 2
- 238000005192 partition Methods 0.000 description 2
- 230000002085 persistent effect Effects 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 239000008107 starch Substances 0.000 description 2
- 235000019698 starch Nutrition 0.000 description 2
- 230000008961 swelling Effects 0.000 description 2
- LQIAZOCLNBBZQK-UHFFFAOYSA-N 1-(1,2-Diphosphanylethyl)pyrrolidin-2-one Chemical compound PCC(P)N1CCCC1=O LQIAZOCLNBBZQK-UHFFFAOYSA-N 0.000 description 1
- 208000004998 Abdominal Pain Diseases 0.000 description 1
- 241000220479 Acacia Species 0.000 description 1
- 201000000736 Amenorrhea Diseases 0.000 description 1
- 206010001928 Amenorrhoea Diseases 0.000 description 1
- 206010002869 Anxiety symptoms Diseases 0.000 description 1
- 206010003591 Ataxia Diseases 0.000 description 1
- 206010007247 Carbuncle Diseases 0.000 description 1
- 206010008469 Chest discomfort Diseases 0.000 description 1
- 208000034656 Contusions Diseases 0.000 description 1
- 241000721047 Danaus plexippus Species 0.000 description 1
- 206010012374 Depressed mood Diseases 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- 229920001353 Dextrin Polymers 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 208000005171 Dysmenorrhea Diseases 0.000 description 1
- 206010013935 Dysmenorrhoea Diseases 0.000 description 1
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 235000018958 Gardenia augusta Nutrition 0.000 description 1
- 208000011688 Generalised anxiety disease Diseases 0.000 description 1
- 208000034507 Haematemesis Diseases 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 206010021118 Hypotonia Diseases 0.000 description 1
- 206010023126 Jaundice Diseases 0.000 description 1
- 206010024453 Ligament sprain Diseases 0.000 description 1
- 208000037093 Menstruation Disturbances Diseases 0.000 description 1
- 206010027339 Menstruation irregular Diseases 0.000 description 1
- 229920000881 Modified starch Polymers 0.000 description 1
- 208000021384 Obsessive-Compulsive disease Diseases 0.000 description 1
- 206010033425 Pain in extremity Diseases 0.000 description 1
- 206010033557 Palpitations Diseases 0.000 description 1
- 206010033664 Panic attack Diseases 0.000 description 1
- 206010034912 Phobia Diseases 0.000 description 1
- 208000001431 Psychomotor Agitation Diseases 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 206010038743 Restlessness Diseases 0.000 description 1
- 206010039897 Sedation Diseases 0.000 description 1
- 206010041250 Social phobia Diseases 0.000 description 1
- 208000010040 Sprains and Strains Diseases 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 206010042464 Suicide attempt Diseases 0.000 description 1
- 206010044565 Tremor Diseases 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 231100000540 amenorrhea Toxicity 0.000 description 1
- 230000001430 anti-depressive effect Effects 0.000 description 1
- 239000000935 antidepressant agent Substances 0.000 description 1
- 229940005513 antidepressants Drugs 0.000 description 1
- 239000002249 anxiolytic agent Substances 0.000 description 1
- 230000002567 autonomic effect Effects 0.000 description 1
- 229940049706 benzodiazepine Drugs 0.000 description 1
- 150000001557 benzodiazepines Chemical class 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 230000001914 calming effect Effects 0.000 description 1
- 230000009519 contusion Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 229960003529 diazepam Drugs 0.000 description 1
- 206010013663 drug dependence Diseases 0.000 description 1
- 206010013781 dry mouth Diseases 0.000 description 1
- 229960002336 estazolam Drugs 0.000 description 1
- CDCHDCWJMGXXRH-UHFFFAOYSA-N estazolam Chemical compound C=1C(Cl)=CC=C(N2C=NN=C2CN=2)C=1C=2C1=CC=CC=C1 CDCHDCWJMGXXRH-UHFFFAOYSA-N 0.000 description 1
- 230000021824 exploration behavior Effects 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 208000029364 generalized anxiety disease Diseases 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 239000012676 herbal extract Substances 0.000 description 1
- 235000008216 herbs Nutrition 0.000 description 1
- 208000006278 hypochromic anemia Diseases 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000006742 locomotor activity Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 230000007721 medicinal effect Effects 0.000 description 1
- 230000007074 memory dysfunction Effects 0.000 description 1
- 206010027175 memory impairment Diseases 0.000 description 1
- 230000027939 micturition Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000009456 molecular mechanism Effects 0.000 description 1
- 230000036640 muscle relaxation Effects 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 208000015238 neurotic disease Diseases 0.000 description 1
- 230000036565 night sweats Effects 0.000 description 1
- 206010029410 night sweats Diseases 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 238000003359 percent control normalization Methods 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 231100000614 poison Toxicity 0.000 description 1
- 230000007096 poisonous effect Effects 0.000 description 1
- 208000028173 post-traumatic stress disease Diseases 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 208000020016 psychiatric disease Diseases 0.000 description 1
- 238000010926 purge Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000036280 sedation Effects 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 208000013220 shortness of breath Diseases 0.000 description 1
- 208000019116 sleep disease Diseases 0.000 description 1
- 201000001716 specific phobia Diseases 0.000 description 1
- 230000002269 spontaneous effect Effects 0.000 description 1
- 238000010025 steaming Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 208000011117 substance-related disease Diseases 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 210000004243 sweat Anatomy 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
- 229940126673 western medicines Drugs 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- 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
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- 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)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
-
- 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)
- A61K36/74—Rubiaceae (Madder family)
- A61K36/744—Gardenia
-
- 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
- A61P25/22—Anxiolytics
-
- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
Definitions
- the invention belongs to the technical field of natural medicines, in particular to a traditional Chinese medicine compound composition, a preparation method and application thereof, and in particular to a traditional Chinese medicine compound composition with anti-anxiety effect and its preparation method and application.
- Anxiety disorder also known as anxiety neurosis, is a mental disorder characterized by anxiety.
- a neurotic disorder characterized by widespread and persistent anxiety or recurrent panic attacks, which can cause autonomic symptoms such as dizziness, chest tightness, palpitations, shortness of breath, dry mouth, frequent urination, urgency, sweating, tremor, and movement Sexual tension.
- the drugs for the treatment of anxiety disorders are mainly western medicines, which often lead to adverse reactions such as muscle relaxation, sedation, ataxia, forgetfulness, drug dependence, memory dysfunction and other adverse reactions in the process of use/taking.
- these drugs have anxiolytic effects, their duration of action is short, and long-term use is addictive and is not conducive to the recovery of patients.
- the object of the present invention is to aim at the problems existing in the prior art, and provide a kind of Chinese medicine compound composition with anxiolytic effect, the Chinese medicine compound composition has no toxic and side effects, and has remarkable therapeutic effect, and can be used as a dietary supplement or Health food raw materials for preventing and treating anxiety disorders and promoting mental health.
- Depression is a syndrome characterized by significant and persistent depression, mainly manifested as low mood, decreased speech, mental and motor retardation, frequent self-blame, and even suicide attempts.
- Two different mental and psychological diseases but it is common for them to coexist in the same patient clinically.
- Patients with depression accompanied by anxiety symptoms have more severe illness, more complex clinical symptoms, and a lower cure rate. Therefore, according to the symptoms Severe, sequential treatment is more effective and the cure rate is higher. Therefore, on the basis of the previous patent of antidepressant compound traditional Chinese medicine, a compound traditional Chinese medicine with anti-anxiety effect was developed to relieve anxiety and insomnia. .
- a traditional Chinese medicine compound composition with anti-anxiety effect is composed of the following traditional Chinese medicine extracts, according to the mass percentage:
- the traditional Chinese medicine compound composition is composed of the following traditional Chinese medicine extracts, calculated by mass percentage:
- the Chinese herbal extract is prepared by extracting Chinese herbal medicines
- the Chinese herbal compound composition is prepared by separately extracting white peony root, gardenia, acacia and peony bark.
- Baishao [Functions and Indications] Nourishes blood and regulates menstruation, astringes yin and stops sweating, softens liver and relieves pain, and calms liver yang. For blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondral pain, abdominal pain, cramping pain in limbs, headache and dizziness.
- Acacia [Functions and Indications] Relieve depression and soothe the nerves. For restlessness, depression and insomnia.
- Cortex Moutan [Functions and Indications] Clearing heat and cooling blood, promoting blood circulation and removing blood stasis. It is used for heat entering into the camp blood, warm poisonous spots, vomiting blood and epistaxis, hot nights and early coolness, no sweating and bone steaming, amenorrhea, dysmenorrhea, pain from falls, carbuncles, swollen sores.
- This recipe uses white peony as the main medicine, which mainly has the functions of nourishing blood and regulating menstruation, astringing yin and relieving sweat, softening liver and relieving pain, and calming liver yang.
- gardenia and peony bark have the effect of cooling blood and detoxifying, gardenia is more focused on diarrhea. Fire removes vexation, clears heat and disperses dampness, while peony bark has the functions of promoting blood circulation and removing blood stasis, relieving deficiency and heat, and Albizia japonica has the effect of relieving depression and soothing the mind. disease.
- the prescription is an organic whole after the combination of multiple herbs for the disease, and its medicinal effect is not equal to the amount of each flavor based on the commonly used amount.
- Simple superposition according to the commonly used amount of each traditional Chinese medicine, it is usually not possible to determine the amount of the drug in the prescription.
- the proportion of medicinal materials is determined by various considerations such as the characteristics of the medicinal materials, the compatibility of the monarch, ministers, assistants and envoys. It is not a simple method of comparison and orthogonality. Such experimental means can be optimally obtained.
- Another object of the present invention is to provide a preparation method of a traditional Chinese medicine compound composition with anti-anxiety effect, comprising: extracting white peony root, gardenia, acacia and peony bark respectively, purifying macroporous resin, concentrating and drying to prepare The obtained traditional Chinese medicine extract is prepared after mixing evenly; specifically:
- step (1) purifying, concentrating, and drying the combined extract in step (1), and sieving to obtain a traditional Chinese medicine extract
- the volume ratio of the Chinese medicinal materials added to the ethanol solution/purified water is 1: (5-20), and the number of times of heating and refluxing extraction of the Chinese medicinal materials is 1-3 times, and the extraction time is 1- 3h.
- the volume ratio of the added solvent to the medicinal residue is (6-8):1
- the medicinal residue is heated and refluxed for 0 to 3 times
- the extraction time of the medicinal residue is 1 to 2 hours.
- the solvent used for further extraction of medicinal residues is deionized water or ethanol solution.
- the drying temperature is 50°C to 100°C
- the sieving mesh number is 60 to 80 meshes.
- the preparation method of the above-mentioned traditional Chinese medicine compound composition comprises the following steps:
- Cortex Moutan medicinal materials pulverized to obtain coarse powder, add 14 times the amount of purified water, stand for 24 hours, heat to recover 9 times the amount of fractions, refrigerate for 24 hours, crystallize and filter, and dry at low temperature to obtain the Cortex Moutan extract;
- Another object of the present invention is to provide the application of the above-disclosed traditional Chinese medicine compound composition with anxiolytic effect in the preparation of health care products.
- the Chinese medicine compound composition can be used as the raw material of dietary supplement or health food for preventing or treating anxiety, promoting mental health, and the dosage form of the Chinese medicine compound composition is capsule, granule or tablet. .
- the present invention provides a traditional Chinese medicine compound composition with anxiolytic effect and its preparation method and application, which have the following excellent effects:
- the present invention follows the compatibility theory of traditional Chinese medicine, combines white peony root, gardenia, acacia, and Cortex Moutan to innovate, and finally designs a traditional Chinese medicine compound composition with the treatment of anxiety disorder and the improvement of sleep disorders.
- the present invention adopts the preparation process of separate extraction and compounding of medicinal materials to determine the main active substances. Compared with the traditional Chinese medicine extraction method, the quality of the extract is more stable and the product is more controllable.
- the traditional Chinese medicine compound composition disclosed and protected by the present invention has been verified by animal experiments and molecular mechanism experiments to verify its efficacy, and it has been confirmed that it has a good anti-anxiety effect.
- the traditional Chinese medicine compound composition disclosed in the present invention has no toxic and side effects, is easily absorbed, and is used for the treatment of anxiety, upset, insomnia, etc., and the traditional Chinese medicine compound composition disclosed in the present invention can be used as a dietary supplement or a health food raw material for preventing Or treating anxiety disorders and promoting mental health, it can be seen that the traditional Chinese medicine compound composition disclosed in the present invention is suitable for promotion and application.
- Figure 1 shows the effect of the test drug on the open field behavior of mice.
- FIG. 1 shows the effects of the tested drugs on the behavior of EPM in mice.
- Figure 3 shows the effects of the tested drugs on the behavior of mice in the light and dark box.
- the embodiment of the present invention discloses a traditional Chinese medicine compound composition that has no toxic side effects, is easy to absorb and has obvious effects. Promote mental health, suitable for market promotion.
- a compound composition of traditional Chinese medicine extracts with anti-anxiety effect comprising the following parts by weight: 120 parts of white peony root, 60 parts of gardenia, 100 parts of acacia flowers, and 100 parts of peony bark
- the preparation method of above-mentioned traditional Chinese medicine compound composition comprises the following steps:
- Cortex Moutan medicinal materials pulverized to obtain coarse powder, add 14 times the amount of purified water, stand for 24 hours, heat to recover 9 times the amount of fractions, refrigerate for 24 hours, crystallize and filter, and dry at low temperature to obtain the extract of Cortex Moutan;
- a traditional Chinese medicine extract compound composition with anti-anxiety effect comprising the following parts by weight: 120 parts of white peony root, 60 parts of gardenia, 100 parts of Albizia japonica, and 100 parts of Cortex Moutan;
- the preparation method of above-mentioned traditional Chinese medicine compound composition comprises the following steps:
- Cortex Moutan medicinal materials pulverized to obtain coarse powder, add 14 times the amount of purified water, stand for 24 hours, heat to recover 9 times the amount of fractions, refrigerate for 24 hours, crystallize and filter, and dry at low temperature to obtain the extract of Cortex Moutan;
- a compound composition of traditional Chinese medicine extracts with anti-anxiety effect comprising the following parts by weight: 120 parts, 60 parts of Gardenia, 100 parts of Albizia Julibrissin, 100 parts of Cortex Moutan
- the preparation method of above-mentioned traditional Chinese medicine compound composition comprises the following steps:
- Cortex Moutan medicinal materials pulverized to obtain coarse powder, add 14 times the amount of purified water, stand for 24 hours, heat to recover 9 times the amount of fractions, refrigerate for 24 hours, crystallize and filter, and dry at low temperature to obtain the extract of Cortex Moutan;
- a traditional Chinese medicine extract compound composition with anti-anxiety effect comprising the following parts by weight: 120 parts of white peony root, 60 parts of gardenia, 100 parts of Albizia japonica, and 100 parts of Cortex Moutan;
- the preparation method of above-mentioned traditional Chinese medicine compound composition comprises the following steps:
- Cortex Moutan medicinal materials pulverized to obtain coarse powder, add 14 times the amount of purified water, stand for 24 hours, heat to recover 9 times the amount of fractions, refrigerate for 24 hours, crystallize and filter, and dry at low temperature to obtain the extract of Cortex Moutan;
- the traditional Chinese medicine compound composition disclosed and prepared by the present invention is specifically applied to the preparation of health food, wherein the preparation of common pharmaceutical dosage forms is as follows:
- Example 2 The extract prepared in Example 2 was mixed uniformly and passed through an 80-mesh sieve to obtain a traditional Chinese medicine compound, then starch and magnesium stearate were added and mixed uniformly, compressed into tablets, and film-coated to prepare tablets.
- Example 2 Mix the extract prepared in Example 2 evenly, and continue to boil to 1 g/mL; then put the boiled extract into a beaker, add weighed sucrose, starch and dextrin, mix well, and when stirring When kneaded into a ball and it disintegrates when touched, the particles that cannot pass through the 20-mesh sieve and the 80-mesh sieve but can pass through the 10-mesh sieve should be placed in an oven to dry in time, and collected for later use.
- the prepared granules are put into a vacuum dryer for drying, and the water content of the granules is controlled to be 4%, so as to prepare the traditional Chinese medicine compound granules.
- Example 2 The extract prepared in Example 2 was mixed uniformly and passed through an 80-mesh sieve to obtain a traditional Chinese medicine compound, then pregelatinized starch was added, talc and magnesium stearate were mixed uniformly, and the capsules were canned to obtain a traditional Chinese medicine compound capsule.
- mice were acclimated to the experiment for a week after arrival. Each group of 12 animals was divided into 5 groups according to the random block design method: positive drug group (diazepam), normal control group, Example 5 group high-dose, Example 6 group low-dose, Example 6 group high-dose.
- mice were given gavage at a fixed time (9:00) every morning, the gavage volume was 0.1 mL ⁇ 10 g -1 , the administration lasted for one month, and the behavior was measured 1 h after the last gavage.
- the experiment was carried out in an open field box with a length of 50 cm, a width of 50 cm and a depth of 50 cm.
- the bottom of the open field box was equally divided into 9 squares, the central area was the central area, and the remaining area was the peripheral area.
- the bottom and sides of the open field box are all white.
- the experiment was carried out in a quiet weak red light environment. At the beginning, the mice were placed in the center of the open field box to observe the activity within 6 minutes. The total movement distance, central area movement distance and central area entry times of the mice were recorded.
- the EPM experimental system includes two 35cm ⁇ 6cm opposite open arms and two 35cm ⁇ 6cm opposite closed arms.
- the upper part of the closed arms is open, the open arms are open all around, and there is a 5cm ⁇ 5cm opposite arm in the center between the open arms and the closed arms. open department.
- the maze is 50cm from the ground.
- the mice were placed in the central open section with the head facing the open arms.
- the Supermaze software recorded the number of times the mice entered the open and closed arms and the retention time of the two arms within 5 minutes (taking all limbs entering or exiting the arms as the standard). Calculate the percentage (percentage) of the times and time that the mice entered the open arms to the total times (the sum of the times of the two arms) and the total time (the sum of the residence time of the two arms).
- mice in each administration group were significantly increased compared with the control group. It shows that each drug can significantly enhance the open arm activity of mice, and has good anxiolytic activity.
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mycology (AREA)
- General Health & Medical Sciences (AREA)
- Botany (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Nutrition Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
一种具有抗焦虑作用的中药复方组合物及其制备方法与应用，通过将白芍、栀子、合欢花与牡丹皮单独提取得到的提取物进行复配制备出一种具有抗焦虑作用的中药复方组合物，该中药复方组合物无副作用、效果显著，可用于治疗焦虑心烦、失眠等症，并且该中药复方组合物可作为膳食补充剂或保健食品原料，用于预防或者治疗焦虑症、促进心理健康。
Description
本发明属于天然药物技术领域，具体为一种中药复方组合物及其制备方法与应用，尤其涉及一种具有抗焦虑作用的中药复方组合物及其制备方法与应用。
焦虑症又称焦虑性神经症，是一种以焦虑情绪为主的精神疾病。以广泛和持续性焦虑或反复发作的惊恐不安为主要特征的神经症性障碍，可引起头晕、胸闷、心悸、呼吸急促、口干、尿频、尿急、出汗、震颤等植物神经症状和运动性紧张。现阶段有6种主要的焦虑症，包括广泛性焦虑障碍、社交焦虑障碍、惊恐障碍、创伤后应激障碍、强迫症和特定恐惧症。随着社会的进步，人们工作学习压力越来越大，焦虑症患者越来越多，并已成为神经科学的研究热点领域之一。
目前治疗焦虑症的药物主要以西药为主，在使用/服用过程中经常会导致患者如肌肉松弛、镇静、共济失调、健忘、药物依赖、记忆功能障碍等不良反应，临床中治疗焦虑症的药物主要有三种摄取抑制类、苯二氮卓类、艾司唑仑类，虽然这些药物均具有抗焦虑作用，但是作用时间较短，长时间服用有成瘾性且不利于患者康复。
因此，如何开发一种无毒副作用、效果显著且用于预防或者治疗焦虑症、促进心理健康的中药复方组合物是本领域技术人员亟需解决的问题。
发明内容
有鉴于此，本发明的目的是针对现有技术中存在的问题，提供一种具有抗焦虑作用的中药复方组合物，该中药复方组合物无毒副作用、治疗效果显著，能够作为膳食补充剂或者保健食品原料，用于预防与治疗焦虑症、促进心理健康。
为了实现上述目的，本发明采用如下技术方案：
因抑郁症是一种以显著而持久的心境低落为主要特征的综合征，主要表现有情绪低落，言语减少，精神、运动迟缓，常自责自罪，甚至企图自杀等，虽然抑郁与焦虑是两种不同的精神心理性疾病，但临床上两者共存于同一患者的现象很常见，抑郁症伴有焦虑症状的患者，其病情更重，临床症状更复杂，治愈率更低，所以按症状偏重，依次治疗更为有效，且治愈率更高，因此在之前已有抗抑郁复方中药专利的基础上，又开发一种具有抗焦虑作用的复方中药，以用于缓解焦虑情绪，失眠等症。
一种具有抗焦虑作用的中药复方组合物，所述中药复方组合物是由以下中药提取物组成，按照质量百分比计：
优选的，所述中药复方组合物是由以下中药提取物组成，按照质量百分比计：
进一步优选的，所述中药提取物是由中药材经提取制得，且所述中药复方组合物为白芍、栀子、合欢花与牡丹皮经单独提取后复配制得。
值得说明的是，本发明公开的中药提取物所用中药材是通过科学的依据(从抗焦虑相关的方剂)进行筛选，有机结合，并根据中医理论配伍，而不是根据单一中药功效进行的简单叠加，具体的各种中药材的功效如下：
白芍：【功能与主治】养血调经，敛阴止汗，柔肝止痛，平抑肝阳。用于血虚萎黄，月经不调，自汗，盗汗，胁痛，腹痛，四肢挛痛，头痛眩晕。
栀子：【功能与主治】泻火除烦，清热利湿，凉血解毒；外用消肿止痛。 用于热病心烦，湿热黄疸，淋证涩痛，血热吐衄，目赤肿痛，火毒疮疡；外治扭挫伤痛。
合欢花：【功能与主治】解郁安神。用于心神不安，忧郁失眠。
牡丹皮：【功能与主治】清热凉血，活血化瘀。用于热入营血，温毒发斑，吐血衄血，夜热早凉，无汗骨蒸，经闭痛经，跌扑伤痛,痈肿疮毒。
本方以白芍为主药，主要有养血调经，敛阴止汗，柔肝止痛，平抑肝阳的功效；栀子与牡丹皮虽然都有凉血解毒的功效，但是栀子偏重于泻火除烦，清热利湿，而牡丹皮则是活血化瘀、退虚热等功效，加上合欢花具有解郁安神的功效，四味中药相辅相成，共同作用，用于治疗焦虑心烦、失眠等症。
另外，在现有技术中，虽然每味中药的常用量是已知的，但是方剂是针对病症对多味药配伍后的有机整体，其药效不等同于其各药味在常用量基础上的简单叠加，根据每味中药的常用量通常并不能确定其在方剂中的药量，药材用量配比由其药材特性、君臣佐使配伍等各种考虑因素决定，并非简单的通过比较法、正交法等实验手段即可优选得出。
本发明还有一个目的，就是提供一种具有抗焦虑作用的中药复方组合物的制备方法，包括：将白芍、栀子、合欢花与牡丹皮分别提取、大孔树脂纯化、浓缩及干燥制得的中药提取物混合均匀后制得；具体为：
(1)将中药材与乙醇溶液/纯化水按照配比加热回流提取后过滤，并将药渣多次提取后的提取液合并，备用；
(2)将步骤(1)合并的所述提取液纯化、浓缩后干燥，过筛得到中药提取物；
(3)将步骤(2)中所述中药提取物按照上述公开的配比混合均匀，得到具有抗焦虑作用的中药复方组合物。
优选的，所述步骤(1)中，添加中药材与乙醇溶液/纯化水的体积比为1：(5～20)，且中药材加热回流提取次数为1～3次，提取时间为1～3h。
进一步的，添加溶剂与药渣的体积比为(6～8)：1，并将所述药渣加热回流提取0～3次，及药渣加热回流提取时间为1～2h。
需要说明的是，药渣进一步提取使用溶剂为去离子水或乙醇溶液。
优选的，所述步骤(2)中，干燥温度为50℃～100℃，过筛目数为60～80目。
具体的，上述中药复方组合物的制备方法，包括如下步骤：
(1)白芍药材加8倍体60-80％乙醇，加热回流提取2h，滤过，药渣加6倍体去离子水，加热回流提取2次，每次1h，合并提取液，浓缩至稠膏，50-80℃减压干燥，粉碎过80目筛，得白芍提取物；
(2)栀子药材，粉碎得粗粉，加6倍、5倍、4倍60-80％乙醇，加热回流提取提取3次，每次2h，滤过，合并提取液，纯化，浓缩，50-80℃减压干燥，粉碎过80目筛，得栀子提取物；
(3)合欢花药材，粉碎得粗粉，加8倍体60-75％乙醇，加热回流提取2次，每次2h，滤过，浓缩，50-75℃减压干燥，过80目筛，得合欢花提取物；
(4)牡丹皮药材，粉碎得粗粉，加14倍量纯化水，静置24小时，加热回收9倍量馏分，冷藏24小时，析晶过滤，低温干燥，得牡丹皮提取物；
(5)将上述步骤(1)～(4)得到的提取物按照配比混合均匀，即可得到所述具有抗焦虑作用的中药复方组合物。
此外，本发明另外一个目的是提供上述公开的一种具有抗焦虑作用的中药复方组合物在制备保健品中的应用。
进一步的，所述中药复方组合物可以作为膳食补充剂或保健食品的原料，用于预防或者治疗焦虑症、促进心理健康，且所述中药复方组合物的剂型为胶囊剂、颗粒剂或片剂。
经由上述技术方案可知，与现有技术相比，本发明提供了一种具有抗焦虑作用的中药复方组合物及其制备方法与应用，具有如下优异效果：
1.本发明遵循传统中医药配伍理论，将白芍、栀子、合欢花、牡丹皮联合创新，最终设计出了具有治疗焦虑症、改善睡眠障碍的中药复方组合物。
2.本发明采用药材单独提取后复合的制备工艺，确定主要活性物质，与传统中药提取方法相比，其提取物质量更加稳定，产品可控性更高。
3.本发明公开保护的中药复方组合物通过动物实验、分子机制实验以验证其功效，并确定了其具有良好的抗焦虑作用。
4.本发明公开保护的中药复方组合物无毒副作用、易吸收，用于治疗焦虑心烦、失眠等症，并且本发明公开的中药复方组合物可作为膳食补充剂或保健食品原料，用于预防或者治疗焦虑症、促进心理健康，由此可见，本发明公开的中药复方组合物适于推广与应用。
为了更清楚地说明本发明实施例，下面将对实施例中所需要使用的附图做简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可根据提供的附图获得其他的附图。
图1为待试药物对小鼠旷场行为的影响。
图2为待试药物对小鼠EPM行为的影响。
图3为待试药物对小鼠明暗箱行为的影响。
下面将结合说明书及相应的实施例对本发明公开的技术方案进行清楚、完整地描述，显然，所描述的实施例仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明实施例公开了一种无毒副作用、易吸收且效果显著的中药复方组合物，该中药复方组合物具有抗焦虑作用，可作为膳食补充剂或保健食品原料用于预防或治疗焦虑症、促进心理健康，适于市面推广。
为更好地理解本发明，下面通过以下实施例对本发明作进一步具体的阐述，但不可理解为对本发明的限定，对于本领域的技术人员根据上述发明内容所作的一些非本质的改进与调整，也视为落在本发明的保护范围内。
下面将结合具体实施例对本发明公开的技术方案作进一步的说明。
实施例1：
一种具有抗焦虑作用的中药提取物复方组合物，包括以下重量份组成：白芍120份、栀子60份、合欢花100份、牡丹皮100份
且，上述中药复方组合物的制备方法，包括以下步骤：
(1)白芍药材加8倍体75％乙醇，加热回流提取2h，滤过，药渣加6倍体去离子水，加热回流提取2次，每次1h，合并提取液，浓缩至稠膏，60℃减压干燥，粉碎过80目筛，得白芍提取物；
(2)栀子药材，粉碎得粗粉，加6倍、5倍、4倍80％乙醇，加热回流提取提取3次，每次2h，滤过，合并提取液，纯化，浓缩，60℃减压干燥，粉碎过80目筛，得栀子提取物；
(3)合欢花药材，粉碎得粗粉，加8倍体60％乙醇，加热回流提取2次，每次2h，滤过，浓缩，60℃减压干燥，过80目筛，得合欢花提取物；
(4)牡丹皮药材，粉碎得粗粉，加14倍量纯化水，静置24小时，加热回收9倍量馏分，冷藏24小时，析晶过滤，低温干燥得牡丹皮提取物；
(5)将步骤(1)、(2)、(3)、(4)中所得提取物，按照配比52％、27％、19％、2％混合均匀，即可得到具有抗焦虑作用的中药复方组合物。
实施例2：
一种具有抗焦虑作用的中药提取物复方组合物，包括以下重量份组成：白芍120份、栀子60份、合欢花100份、牡丹皮100份；
且，上述中药复方组合物的制备方法，包括以下步骤：
(1)白芍药材加8倍体70％乙醇，加热回流提取2h，滤过，药渣加6倍体去离子水，加热回流提取2次，每次1h，合并提取液，浓缩至稠膏，60℃减压干燥，粉碎过80目筛，得白芍提取物；
(2)栀子药材，粉碎得粗粉，加6倍、5倍、4倍70％乙醇，加热回流提取提取3次，每次2h，滤过，合并提取液，纯化，浓缩，60℃减压干燥，粉碎过80目筛，得栀子提取物；
(3)合欢花药材，粉碎得粗粉，加8倍体70％乙醇，加热回流提取2次，每次2h，滤过，浓缩，60℃减压干燥，过80目筛，得合欢花提取物；
(4)牡丹皮药材，粉碎得粗粉，加14倍量纯化水，静置24小时，加热回收9倍量馏分，冷藏24小时，析晶过滤，低温干燥得牡丹皮提取物；
(5)将步骤(1)、(2)、(3)、(4)中所得提取物，按照配比52.1％、27.0％、18.7％、2.2％，过80目筛、混合均匀，即可得到具有抗焦虑作用的中药复方组合物。
实施例3：
一种具有抗焦虑作用的中药提取物复方组合物，包括以下重量份组成：120份、栀子60份、合欢花100份、牡丹皮100份
且，上述中药复方组合物的制备方法，包括以下步骤：
(1)白芍药材加8倍体65％乙醇，加热回流提取2h，滤过，药渣加6倍体去离子水，加热回流提取2次，每次1h，合并提取液，浓缩至稠膏，60℃减压干燥，粉碎过80目筛，得白芍提取物；
(2)栀子药材，粉碎得粗粉，加6倍、5倍、4倍70％乙醇，加热回流提取提取3次，每次2h，滤过，合并提取液，纯化，浓缩，60℃减压干燥，粉碎过80目筛，得栀子提取物；
(3)合欢花药材，粉碎得粗粉，加8倍体75％乙醇，加热回流提取2次，每次2h，滤过，浓缩，60℃减压干燥，过80目筛，得合欢花提取物；
(4)牡丹皮药材，粉碎得粗粉，加14倍量纯化水，静置24小时，加热回收9倍量馏分，冷藏24小时，析晶过滤，低温干燥得牡丹皮提取物；
(5)将步骤(1)、(2)、(3)、(4)中所得提取物，按照配比55％、22％、18％、5％，过80目筛混合均匀，即可得到具有抗焦虑作用的中药复方组合物。
实施例4：
一种具有抗焦虑作用的中药提取物复方组合物，包括以下重量份组成：白芍120份、栀子60份、合欢花100份、牡丹皮100份；
且，上述中药复方组合物的制备方法，包括以下步骤：
(1)白芍药材加8倍体50％乙醇，加热回流提取2h，滤过，药渣加6倍体去离子水，加热回流提取2次，每次1h，合并提取液，浓缩至稠膏，60℃减压干燥，粉碎过80目筛，得白芍提取物；
(2)栀子药材，粉碎得粗粉，加6倍、5倍、4倍80％乙醇，加热回流提取提取3次，每次2h，滤过，合并提取液，纯化，浓缩，60℃减压干燥，粉碎过80目筛，得栀子提取物；
(3)合欢花药材，粉碎得粗粉，加8倍体60％乙醇，加热回流提取2次，每次2h，滤过，浓缩，60℃减压干燥，过80目筛，得合欢花提取物；
(4)牡丹皮药材，粉碎得粗粉，加14倍量纯化水，静置24小时，加热回收9倍量馏分，冷藏24小时，析晶过滤，低温干燥得牡丹皮提取物；
(5)将步骤(1)、(2)、(3)、(4)中所得提取物，按照配比45％，36％，16％，3％，过80目筛混合均匀，即可得到具有抗焦虑作用的中药复方组合物。
将本发明公开制备的中药复方组合物具体应用到制备保健食品中，其中常见药物剂型的制备如下：
实施例5：
将实施例2制备得到的提取物混合均匀过80目筛，得到中药复合物，随后加入淀粉、硬脂酸镁混合均匀，压制成片，包薄膜衣，制成片剂。
实施例6：
将实施例2制备得到的提取液混合均匀，继续熬至1g/mL；随后将熬制好的浸膏放入烧杯中，加入称量好的蔗糖、淀粉和糊精，混合均匀，当搅拌到手捏成团，触之即散时，筛选不能通过20目筛和80目筛但能通过10目筛的颗粒，及时放入烘箱中干燥，收集备用。
最后将制备得到的颗粒放入真空干燥器进行干燥，并控制颗粒的含水量在4％，以制备得到中药复方颗粒。
实施例7：
将实施例2制备得到的提取物混合均匀过80目筛，得到中药复合物，随后加入预胶化淀粉，滑石粉硬脂酸镁混合均匀并进行罐装胶囊，即得中药复方胶囊。
此外，为了进一步验证本发明技术方案最终产生的技术效果，发明人还进行了如下实验：
一、药效实验
1、分组：小鼠运抵后适应一周进入实验。每组12只，按照随机区组设计方法分为5组：阳性药组(地西泮)、正常对照组、实施例5组大剂量、实施例6组小剂量、实施例6组大剂量。
2、给药：正常组灌胃同体积纯净水，其他各组灌胃剂量见下述结果表格部分说明。每天上午固定时间(9:00)对小鼠实施灌胃，灌胃体积为0.1mL·10g
-1，给药持续一个月，最后一次灌胃后1h进行行为测定。
表1
| 组别 | 剂量 | 动物数 |
| 对照组 | / | 12 |
| 地西泮组 | 2mg/kg | 12 |
| 实施例5组大剂量 | 446.67mg/kg | 12 |
| 实施例6组大剂量 | 446.67mg/kg | 12 |
| 实施例6组小剂量 | 223.33mg/kg | 12 |
3、试验方法：
3.1、小鼠旷场实验
实验于长50cm，宽50cm，深50cm的旷场箱内进行，旷场箱底面等分成9个正方形，正中间区域为中央区，剩余区域为外周区。旷场箱底部和四周全部为白色。实验于安静的弱红光环境下进行，开始时把小鼠放于旷场箱中央，观察6min内的活动情况。记录小鼠的运动总路程、中央区运动路程和中央区进入次数。
3.2、小鼠EPM实验
EPM实验系统包括2个35cm×6cm的相对开臂和2个35cm×6cm的相对闭臂，闭臂上部敞开，开臂四周均敞开，开臂与闭臂之间中央有一个5cm×5cm的相对开阔部。迷宫离地面50cm。将小鼠置于中央开阔部，头朝开臂。Supermaze软件记录5min内小鼠进入开臂与闭臂的次数和两臂滞留的时间 (以四肢全部入臂或出臂为标准)。计算小鼠进入开臂的次数与时间分别占总次数(两臂次数之和)和总时间(两臂滞留时间之和)的百分比(占比)。
3.3、小鼠明暗箱实验
明暗箱由一个整体箱体被中间插门(6.5cm×6.5cm)分隔为两个相同尺寸(L×W×H＝25cm×25cm×30cm)隔间(明区和暗区)组成，明区由白色灯光照明，暗区由红色灯光照明。实验开始时每只小鼠面向隔墙放入明区中央，抽走中隔板间插门。动物四个爪子进入隔间一次即记作一次进入。Supermaze软件记录记录5min内小鼠明区路程、明区停留时间和明区进入次数。
4、试验结果：
4.1、旷场实验
表2待试药物对小鼠旷场实验的影响
注：与对照组比较，*p<0.05，**p<0.01，***p<0.001。
由上述表2中结果数据可知，灌胃一月后，各给药组小鼠旷场运动总路程均较对照组显著增加；除实施例5组大剂量外，其余各给药组中央区路程均较对照组显著增加；除实施例5组大剂量外，其余各给药组中央区进入次数均较对照组显著增加。表明给药后小鼠运动活性显著增强。除实施例5组大剂量外，其余药物均显著增强小鼠中央区活动，有较好抗焦虑活性，且实施例6组小剂量效果最好，其次是实施例6组大剂量、实施例5组大剂量。
4.2、小鼠EPM实验
表3待试药物对小鼠EPM实验的影响
| 组别 | 动物数 | OE％ | OT％ |
| 对照组 | 9 | 0.2348±0.01689 | 0.1260±0.02201 |
| 地西泮组 | 9 | 0.3061±0.02734* | 0.1981±0.03287* |
| 实施例5组大剂量 | 8 | 0.3383±0.02640** | 0.1919±0.01960* |
| 实施例6组大剂量 | 8 | 0.2915±0.01682* | 0.1965±0.02260* |
| 实施例6组小剂量 | 11 | 0.3386±0.02554** | 0.1899±0.02591* |
注：与对照组比较，*p<0.05，**p<0.01，***p<0.001。
由上述表3中结果数据可知，灌胃一月后，各给药组小鼠OE％、OT％均较对照组显著增加。表明各药物均显著增强小鼠开放臂活动，有较好抗焦虑活性。
4.3、明暗箱实验
表4待试药物对小鼠明暗箱实验中明区路程的影响
| 组别 | 动物数 | 明区路程 | 明区停留时间 | 明区进入次数 |
| 对照组 | 10 | 13399±665.3 | 131.7±5.421 | 12.10±1.027 |
| 地西泮组 | 12 | 18141±1011*** | 152.1±6.860* | 18.92±1.540** |
| 实施例5组大剂量 | 8 | 16861±907.1** | 147.5±3.737* | 20.00±1.535*** |
| 实施例6组大剂量 | 11 | 15432±695.8* | 139.8±7.128 | 15.64±1.146* |
| 实施例6组小剂量 | 9 | 15664±928.9* | 150.8±7.514* | 17.11±1.670** |
注：与对照组比较，*p<0.05，**p<0.01，***p<0.001。
由上述表4中结果数据可知，灌胃一月后，各给药组明区路程均较对照组显著增加；实施例5组、实施例6组小剂量给药组明区停留时间均较对照组显著延长；各给药组小鼠明区进入次数均较对照组显著增加。表明各药物均显著增强小鼠明区活动，具有抗焦虑活性，且实施例5组大剂量、实施例6组小剂量组效果较好。
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易 见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。
Claims (9)
- 一种具有抗焦虑作用的中药复方组合物，其特征在于，所述中药复方组合物是由以下中药提取物组成，按照质量百分比计：
- 根据权利要求1所述的一种具有抗焦虑作用的中药复方组合物，其特征在于，所述中药复方组合物是由以下中药提取物组成，按照质量百分比计：
- 根据权利要求1～2任一所述的一种具有抗焦虑作用的中药复方组合物，其特征在于，所述中药提取物是由中药材经提取制得，且所述中药复方组合物为白芍、栀子、合欢花与牡丹皮经单独提取后复配制得。
- 一种如权利要求1～3任一所述的具有抗焦虑作用的中药复方组合物的制备方法，其特征在于，包括：将白芍、栀子、合欢花与牡丹皮分别提取、大孔树脂纯化、浓缩及干燥制得的中药提取物混合均匀后制得；具体为：(1)将中药材与乙醇溶液/纯化水按照配比加热回流提取后过滤，并将药渣多次提取后的提取液合并，备用；(2)将步骤(1)合并的所述提取液纯化、浓缩后干燥，过筛得到中药提取物；(3)将步骤(2)中所述中药提取物按照如权利要求1公开的配比混合均匀，得到具有抗焦虑作用的中药复方组合物。
- 根据权利要求4所述的一种具有抗焦虑作用的中药复方组合物的制备方法，其特征在于，所述步骤(1)中，添加中药材与乙醇溶液/纯化水的体积比为1：(5～20)，且中药材加热回流提取次数为1～3次，提取时间为1～3h。
- 根据权利要求4或5所述的一种具有抗焦虑作用的中药复方组合物的制备方法，其特征在于，添加溶剂与药渣的体积比为(6～8)：1，并将所述药渣加热回流提取0～3次，及药渣加热回流提取时间为1～2h。
- 根据权利要求4所述的一种具有抗焦虑作用的中药复方组合物的制备方法，其特征在于，所述步骤(2)中，干燥温度为50℃～100℃，过筛目数为60～80目。
- 一种如权利要求1～2任一所述的具有抗焦虑作用的中药复方组合物或如权利要求4～7任一所述方法制备的中药复方组合物在制备保健食品中的应用。
- 根据权利要求8所述的一种具有抗焦虑作用的中药复方组合物的应用，其特征在于，所述中药复方组合物可以作为膳食补充剂或保健食品的原料，且所述中药复方组合物的剂型为胶囊剂、颗粒剂或片剂。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US17/315,224 US20220175865A1 (en) | 2020-12-07 | 2021-05-07 | Traditional chinese medicine compound composition with anti-anxiety effect and preparation method and applications thereof |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011437190.5 | 2020-12-07 | ||
| CN202011437190.5A CN112426454B (zh) | 2020-12-07 | 2020-12-07 | 一种具有抗焦虑作用的中药复方组合物及其制备方法与应用 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US17/315,224 Continuation US20220175865A1 (en) | 2020-12-07 | 2021-05-07 | Traditional chinese medicine compound composition with anti-anxiety effect and preparation method and applications thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2022120906A1 true WO2022120906A1 (zh) | 2022-06-16 |
Family
ID=74691203
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CN2020/136657 WO2022120906A1 (zh) | 2020-12-07 | 2020-12-16 | 一种具有抗焦虑作用的中药复方组合物及其制备方法与应用 |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN112426454B (zh) |
| WO (1) | WO2022120906A1 (zh) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1634179A (zh) * | 2003-12-26 | 2005-07-06 | 广州中医药大学 | 一种从丹栀逍遥散中提取的复合物及其应用 |
| CN101310740A (zh) * | 2007-05-24 | 2008-11-26 | 上海欣生源药业有限公司 | 一种抗焦虑复方中药及其制备方法 |
| CN110538232A (zh) * | 2019-09-30 | 2019-12-06 | 青岛琛蓝医药科技发展有限公司 | 一种抗抑郁的复合制剂及其制备方法 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101254247B (zh) * | 2008-03-25 | 2011-06-22 | 深圳力瑞医药科技有限公司 | 一种具有抗抑郁、抗焦虑作用的药物组合物及其制备方法 |
| CN103861005B (zh) * | 2014-03-26 | 2016-03-30 | 胡向仟 | 一种具有抗焦虑作用的中药组合物 |
| CN104042720B (zh) * | 2014-07-08 | 2016-03-30 | 河南中医学院 | 具有防治糖尿病并发抑郁症的中药及其应用 |
-
2020
- 2020-12-07 CN CN202011437190.5A patent/CN112426454B/zh active Active
- 2020-12-16 WO PCT/CN2020/136657 patent/WO2022120906A1/zh active Application Filing
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1634179A (zh) * | 2003-12-26 | 2005-07-06 | 广州中医药大学 | 一种从丹栀逍遥散中提取的复合物及其应用 |
| CN101310740A (zh) * | 2007-05-24 | 2008-11-26 | 上海欣生源药业有限公司 | 一种抗焦虑复方中药及其制备方法 |
| CN110538232A (zh) * | 2019-09-30 | 2019-12-06 | 青岛琛蓝医药科技发展有限公司 | 一种抗抑郁的复合制剂及其制备方法 |
Non-Patent Citations (3)
| Title |
|---|
| LI, NING ET AL.: "Ethological Changes in Rats with Chronic Stress-Induced Anxiety and Interventional Effect of Danzhixiaoyao Powder", JOURNAL OF BEIJING UNIVERSITY OF TRADITIONAL CHINESE MEDICINE, vol. 32, no. 12, 31 December 2009 (2009-12-31), pages 826 - 829, XP055941111 * |
| SONG, XIAOLAN: "Clinical application of the same treatment for different diseases", CHINA PRACTICAL MEDICINE, vol. 6, no. 21, 31 July 2011 (2011-07-31), pages 192 - 193, XP055941107 * |
| ZHANG HAO, GENG XIWEN, LI ZIFA, LI YAQIONG, XU KAIYONG, WU HONGYUN, XIE JINLU, SUN PENG, WEI SHENG, QIAO MINGQI: "Paeonol at Certain Doses Alleviates Aggressive and Anxiety-Like Behaviours in Two Premenstrual Dysphoric Disorder Rat Models", FRONTIERS IN PSYCHIATRY, vol. 11, no. 295, pages 1 - 13, XP055941090, DOI: 10.3389/fpsyt.2020.00295 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN112426454A (zh) | 2021-03-02 |
| CN112426454B (zh) | 2022-06-24 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103549433B (zh) | 一种具有保肝护肝功效的中药保健食品 | |
| CN101933991B (zh) | 一种镇痛抗炎药物及其制备方法 | |
| CN101926882A (zh) | 治疗癌症的药物组合物及其制备方法 | |
| CN104491052A (zh) | 治疗风湿及类风湿性关节炎的中药组合物及其制备方法 | |
| CN106728770B (zh) | 一种补肾益精的中药组合物及其制备方法 | |
| CN101912548B (zh) | 一种治疗小儿夜啼的药物及其制备方法 | |
| WO2022120906A1 (zh) | 一种具有抗焦虑作用的中药复方组合物及其制备方法与应用 | |
| CN102580142B (zh) | 一种用于骨科手术术后愈合的中药敷药及制备方法 | |
| CN104083568A (zh) | 一种苗医骨痛膏药及其制备方法 | |
| CN113304223A (zh) | 柔肝醒胃疏气活血宣通窒滞养颜活血收敛抗肿瘤的组合物 | |
| US20220175865A1 (en) | Traditional chinese medicine compound composition with anti-anxiety effect and preparation method and applications thereof | |
| CN112618626A (zh) | 一种治疗带状疱疹的中药喷雾剂及其制备方法 | |
| CN1033998C (zh) | 一种治疗关节炎的药物及其配制方法 | |
| JP2958198B2 (ja) | 鎮痛用医薬組成物 | |
| CN101961411B (zh) | 一种治疗口疮疾病的药物及其制备方法 | |
| CN100471519C (zh) | 一种治疗胃病的药物组合物及其制备方法和用途 | |
| CN102526544B (zh) | 一种治疗腰椎间盘突出及骨质增生的口服散剂中药 | |
| CN102258602A (zh) | 治疗风湿、类风湿的中药组合物及其制备方法 | |
| CN102772461B (zh) | 药物组合物在制备预防或治疗老年性痴呆的药物中的应用 | |
| CN106039211A (zh) | 一种安神镇惊颗粒及其制备方法 | |
| CN105535595A (zh) | 一种安神镇定清燥缓解精神病的中药组合物及其制备方法 | |
| CN1245181C (zh) | 治疗牛皮癣的中药及其制备方法 | |
| CN115919987A (zh) | 一种用于行气止痛的中药组合物及其制备方法 | |
| CN113827672A (zh) | 一种降尿酸中药 | |
| CN104784567B (zh) | 一种治疗泌尿系感染的药物组合物 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 20964839 Country of ref document: EP Kind code of ref document: A1 |
|
| NENP | Non-entry into the national phase |
Ref country code: DE |
|
| 122 | Ep: pct application non-entry in european phase |
Ref document number: 20964839 Country of ref document: EP Kind code of ref document: A1 |