CN108815448B - Traditional Chinese medicine granules for treating chronic colitis - Google Patents
Traditional Chinese medicine granules for treating chronic colitis Download PDFInfo
- Publication number
- CN108815448B CN108815448B CN201810782877.9A CN201810782877A CN108815448B CN 108815448 B CN108815448 B CN 108815448B CN 201810782877 A CN201810782877 A CN 201810782877A CN 108815448 B CN108815448 B CN 108815448B
- Authority
- CN
- China
- Prior art keywords
- parts
- traditional chinese
- chinese medicine
- portions
- treating chronic
- 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
- 239000003814 drug Substances 0.000 title claims abstract description 70
- 230000001684 chronic effect Effects 0.000 title claims abstract description 55
- 206010009887 colitis Diseases 0.000 title claims abstract description 41
- 239000008187 granular material Substances 0.000 title claims abstract description 31
- 229940079593 drug Drugs 0.000 claims abstract description 24
- 238000002360 preparation method Methods 0.000 claims abstract description 23
- 239000002245 particle Substances 0.000 claims description 22
- 240000002943 Elettaria cardamomum Species 0.000 claims description 17
- 235000005300 cardamomo Nutrition 0.000 claims description 17
- 241001180876 Saposhnikovia Species 0.000 claims description 15
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 claims description 15
- 241000132012 Atractylodes Species 0.000 claims description 14
- 239000002994 raw material Substances 0.000 claims description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 13
- 235000013399 edible fruits Nutrition 0.000 claims description 13
- 239000000463 material Substances 0.000 claims description 12
- 241000007126 Codonopsis pilosula Species 0.000 claims description 11
- 241000037740 Coptis chinensis Species 0.000 claims description 9
- 238000001035 drying Methods 0.000 claims description 7
- 239000007767 bonding agent Substances 0.000 claims description 6
- 239000000706 filtrate Substances 0.000 claims description 6
- 238000001914 filtration Methods 0.000 claims description 6
- 239000000843 powder Substances 0.000 claims description 6
- 230000002829 reductive effect Effects 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 238000005303 weighing Methods 0.000 claims description 6
- 238000005507 spraying Methods 0.000 claims description 5
- 241000218202 Coptis Species 0.000 claims description 4
- 235000002991 Coptis groenlandica Nutrition 0.000 claims description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
- 238000005469 granulation Methods 0.000 claims description 4
- 230000003179 granulation Effects 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 238000007873 sieving Methods 0.000 claims description 4
- 241000756943 Codonopsis Species 0.000 claims description 3
- 238000001816 cooling Methods 0.000 claims description 3
- 238000005243 fluidization Methods 0.000 claims description 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 3
- 230000002572 peristaltic effect Effects 0.000 claims description 3
- 230000001105 regulatory effect Effects 0.000 claims description 3
- 241000092665 Atractylodes macrocephala Species 0.000 claims description 2
- 239000012141 concentrate Substances 0.000 claims description 2
- 239000012153 distilled water Substances 0.000 claims description 2
- 238000012869 ethanol precipitation Methods 0.000 claims description 2
- 238000010298 pulverizing process Methods 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 23
- 206010009900 Colitis ulcerative Diseases 0.000 abstract description 17
- 201000006704 Ulcerative Colitis Diseases 0.000 abstract description 17
- 206010067484 Adverse reaction Diseases 0.000 abstract description 5
- 230000006838 adverse reaction Effects 0.000 abstract description 5
- 238000000034 method Methods 0.000 abstract description 5
- 239000000203 mixture Substances 0.000 abstract description 5
- 230000003285 pharmacodynamic effect Effects 0.000 abstract description 5
- 238000011160 research Methods 0.000 abstract description 5
- 238000010171 animal model Methods 0.000 abstract description 3
- 238000002474 experimental method Methods 0.000 abstract description 3
- 241000700159 Rattus Species 0.000 description 34
- 206010012735 Diarrhoea Diseases 0.000 description 15
- 210000001072 colon Anatomy 0.000 description 15
- 208000025865 Ulcer Diseases 0.000 description 9
- 238000012360 testing method Methods 0.000 description 9
- 208000012671 Gastrointestinal haemorrhages Diseases 0.000 description 8
- 208000035861 hematochezia Diseases 0.000 description 8
- 231100000397 ulcer Toxicity 0.000 description 8
- NHJVRSWLHSJWIN-UHFFFAOYSA-N 2,4,6-trinitrobenzenesulfonic acid Chemical compound OS(=O)(=O)C1=C([N+]([O-])=O)C=C([N+]([O-])=O)C=C1[N+]([O-])=O NHJVRSWLHSJWIN-UHFFFAOYSA-N 0.000 description 7
- 239000013641 positive control Substances 0.000 description 7
- 206010061218 Inflammation Diseases 0.000 description 6
- 230000004054 inflammatory process Effects 0.000 description 6
- 210000000952 spleen Anatomy 0.000 description 6
- 230000002496 gastric effect Effects 0.000 description 5
- 208000024891 symptom Diseases 0.000 description 5
- 150000001875 compounds Chemical class 0.000 description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 4
- 230000002401 inhibitory effect Effects 0.000 description 4
- 230000000968 intestinal effect Effects 0.000 description 4
- 230000001737 promoting effect Effects 0.000 description 4
- 239000000341 volatile oil Substances 0.000 description 4
- 241001465754 Metazoa Species 0.000 description 3
- 230000037396 body weight Effects 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 238000011161 development Methods 0.000 description 3
- 230000018109 developmental process Effects 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 230000006872 improvement Effects 0.000 description 3
- 210000004400 mucous membrane Anatomy 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 206010000060 Abdominal distension Diseases 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 2
- 208000032843 Hemorrhage Diseases 0.000 description 2
- 206010020751 Hypersensitivity Diseases 0.000 description 2
- 206010024642 Listless Diseases 0.000 description 2
- 206010028813 Nausea Diseases 0.000 description 2
- 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 2
- 238000009825 accumulation Methods 0.000 description 2
- 229930013930 alkaloid Natural products 0.000 description 2
- 208000026935 allergic disease Diseases 0.000 description 2
- 230000007815 allergy Effects 0.000 description 2
- 210000000436 anus Anatomy 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 208000034158 bleeding Diseases 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 230000004087 circulation Effects 0.000 description 2
- 230000007012 clinical effect Effects 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 150000004676 glycans Chemical class 0.000 description 2
- 230000036039 immunity Effects 0.000 description 2
- 208000017971 listlessness Diseases 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 230000008693 nausea Effects 0.000 description 2
- 239000002504 physiological saline solution Substances 0.000 description 2
- 229920001282 polysaccharide Polymers 0.000 description 2
- 239000005017 polysaccharide Substances 0.000 description 2
- 230000028327 secretion Effects 0.000 description 2
- 238000005728 strengthening Methods 0.000 description 2
- NCEXYHBECQHGNR-QZQOTICOSA-N sulfasalazine Chemical compound C1=C(O)C(C(=O)O)=CC(\N=N\C=2C=CC(=CC=2)S(=O)(=O)NC=2N=CC=CC=2)=C1 NCEXYHBECQHGNR-QZQOTICOSA-N 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 229940126680 traditional chinese medicines Drugs 0.000 description 2
- 230000036269 ulceration Effects 0.000 description 2
- ZTVSGQPHMUYCRS-SWLSCSKDSA-N (4as,8as)-3,8a-dimethyl-5-methylidene-4a,6,7,8-tetrahydro-4h-benzo[f][1]benzofuran-2-one Chemical compound C=C([C@@H]1C2)CCC[C@]1(C)C=C1C2=C(C)C(=O)O1 ZTVSGQPHMUYCRS-SWLSCSKDSA-N 0.000 description 1
- MIDXCONKKJTLDX-UHFFFAOYSA-N 3,5-dimethylcyclopentane-1,2-dione Chemical compound CC1CC(C)C(=O)C1=O MIDXCONKKJTLDX-UHFFFAOYSA-N 0.000 description 1
- 208000004998 Abdominal Pain Diseases 0.000 description 1
- 206010000084 Abdominal pain lower Diseases 0.000 description 1
- 244000059800 Amomum compactum Species 0.000 description 1
- 235000016426 Amomum compactum Nutrition 0.000 description 1
- OQYBLUDOOFOBPO-UHFFFAOYSA-N Asterolide Natural products C1C2C(=C)CCCC2(C)CC2C1=C(C)C(=O)O2 OQYBLUDOOFOBPO-UHFFFAOYSA-N 0.000 description 1
- 241000132011 Atractylodes lancea Species 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 241000099774 Cuscuta salina Species 0.000 description 1
- 241000721047 Danaus plexippus Species 0.000 description 1
- 229920001353 Dextrin Polymers 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- 206010020601 Hyperchlorhydria Diseases 0.000 description 1
- UETNIIAIRMUTSM-UHFFFAOYSA-N Jacareubin Natural products CC1(C)OC2=CC3Oc4c(O)c(O)ccc4C(=O)C3C(=C2C=C1)O UETNIIAIRMUTSM-UHFFFAOYSA-N 0.000 description 1
- 206010067482 No adverse event Diseases 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 102000057297 Pepsin A Human genes 0.000 description 1
- 108090000284 Pepsin A Proteins 0.000 description 1
- 208000004880 Polyuria Diseases 0.000 description 1
- 206010057071 Rectal tenesmus Diseases 0.000 description 1
- 229930182558 Sterol Natural products 0.000 description 1
- 206010042220 Stress ulcer Diseases 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 210000000683 abdominal cavity Anatomy 0.000 description 1
- 206010000059 abdominal discomfort Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 150000003797 alkaloid derivatives Chemical class 0.000 description 1
- 230000003266 anti-allergic effect Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 125000003118 aryl group Chemical group 0.000 description 1
- 239000003212 astringent agent Substances 0.000 description 1
- ZYGHJZDHTFUPRJ-UHFFFAOYSA-N benzo-alpha-pyrone Natural products C1=CC=C2OC(=O)C=CC2=C1 ZYGHJZDHTFUPRJ-UHFFFAOYSA-N 0.000 description 1
- YBHILYKTIRIUTE-UHFFFAOYSA-N berberine Chemical compound C1=C2CC[N+]3=CC4=C(OC)C(OC)=CC=C4C=C3C2=CC2=C1OCO2 YBHILYKTIRIUTE-UHFFFAOYSA-N 0.000 description 1
- 229940093265 berberine Drugs 0.000 description 1
- QISXPYZVZJBNDM-UHFFFAOYSA-N berberine Natural products COc1ccc2C=C3N(Cc2c1OC)C=Cc4cc5OCOc5cc34 QISXPYZVZJBNDM-UHFFFAOYSA-N 0.000 description 1
- 210000001185 bone marrow Anatomy 0.000 description 1
- 235000013736 caramel Nutrition 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- OTAFHZMPRISVEM-UHFFFAOYSA-N chromone Chemical compound C1=CC=C2C(=O)C=COC2=C1 OTAFHZMPRISVEM-UHFFFAOYSA-N 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 235000001671 coumarin Nutrition 0.000 description 1
- 150000004775 coumarins Chemical class 0.000 description 1
- 230000002354 daily effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 229960000633 dextran sulfate Drugs 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 230000035619 diuresis Effects 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 230000002497 edematous effect Effects 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 230000003628 erosive effect Effects 0.000 description 1
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000000855 fermentation Methods 0.000 description 1
- 230000004151 fermentation Effects 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000003394 haemopoietic effect Effects 0.000 description 1
- 230000037308 hair color Effects 0.000 description 1
- 235000013402 health food Nutrition 0.000 description 1
- 230000011132 hemopoiesis Effects 0.000 description 1
- 230000007365 immunoregulation Effects 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 208000028774 intestinal disease Diseases 0.000 description 1
- 150000002596 lactones Chemical class 0.000 description 1
- 210000002429 large intestine Anatomy 0.000 description 1
- 239000004816 latex Substances 0.000 description 1
- 229920000126 latex Polymers 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 210000000713 mesentery Anatomy 0.000 description 1
- 230000004089 microcirculation Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 230000009854 mucosal lesion Effects 0.000 description 1
- 210000003097 mucus Anatomy 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 235000015816 nutrient absorption Nutrition 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 229960001412 pentobarbital Drugs 0.000 description 1
- 229960002275 pentobarbital sodium Drugs 0.000 description 1
- 229940111202 pepsin Drugs 0.000 description 1
- 230000008855 peristalsis Effects 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 150000002989 phenols Chemical class 0.000 description 1
- 230000035755 proliferation Effects 0.000 description 1
- 238000010926 purge Methods 0.000 description 1
- 238000011552 rat model Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 229930182490 saponin Natural products 0.000 description 1
- 150000007949 saponins Chemical class 0.000 description 1
- 235000017709 saponins Nutrition 0.000 description 1
- 210000001599 sigmoid colon Anatomy 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 208000010110 spontaneous platelet aggregation Diseases 0.000 description 1
- 150000003432 sterols Chemical class 0.000 description 1
- 235000003702 sterols Nutrition 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 229960001940 sulfasalazine Drugs 0.000 description 1
- NCEXYHBECQHGNR-UHFFFAOYSA-N sulfasalazine Natural products C1=C(O)C(C(=O)O)=CC(N=NC=2C=CC(=CC=2)S(=O)(=O)NC=2N=CC=CC=2)=C1 NCEXYHBECQHGNR-UHFFFAOYSA-N 0.000 description 1
- 208000012271 tenesmus Diseases 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/238—Saposhnikovia
-
- 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)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/344—Codonopsis
-
- 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
- A61K36/718—Coptis (goldthread)
-
- 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
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
-
- 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)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9064—Amomum, e.g. round cardamom
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive 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
-
- 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
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nutrition Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to the technical field of medicines, in particular to a traditional Chinese medicine granule for treating chronic colitis and application thereof. Pharmacodynamic experiments show that the traditional Chinese medicine composition has a remarkable treatment effect on chronic ulcerative colitis animal models; the invention is clinically used for treating chronic colitis, has obvious curative effect, does not have serious adverse reaction, and is safe and reliable; the invention provides a new effective medicine for the traditional Chinese medicine treatment of chronic colitis, enriches the research content of the traditional Chinese medicine pharmaceutics, and provides a reference for a method for converting the traditional Chinese medicine hospital preparation into a new medicine.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to a traditional Chinese medicine granule for treating chronic colitis and a preparation method and application thereof.
Background
Chronic colitis is a common and frequent intestinal disease with colon, sigmoid colon and rectum as the affected parts, and the main symptoms of the disease are left lower abdominal pain, diarrhea, tenesmus, mucus in stool and stool, constipation or diarrhea occur alternately and are good and bad. According to statistics, the incidence of chronic colitis in China in nearly 10 years is increased by 10 times compared with that in the 50 th century, and the chronic colitis becomes one of common diseases and frequently encountered diseases in clinic. At present, the treatment of chronic colitis by western medicine is only suitable for short-term administration; if the medicine is taken for a long time, various adverse reactions such as serious gastrointestinal reaction, bone marrow hematopoietic function inhibition, allergy and the like can be caused. Therefore, the search and development of novel anti-chronic colitis medicines from traditional Chinese medicines have good development potential and important scientific value. According to the typical clinical manifestations of chronic colitis, the clinical treatment should be mainly done by eliminating dampness and turbid pathogen to treat the symptoms, and strengthening spleen and relieving diarrhea to treat diarrhea.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine granule for treating chronic colitis and a preparation method and application thereof.
The invention relates to a traditional Chinese medicine granule for treating chronic colitis, which is a special preparation for treating chronic colitis and consists of 7 medicines of largehead atractylodes rhizome, pilose asiabell root, round cardamom, golden thread, divaricate saposhnikovia root, dark plum fruit and red halloysite. The prescription selects the rhizoma atractylodis macrocephalae with the functions of strengthening spleen and replenishing qi, clearing heat and drying dampness, purging liver and relieving hyperacidity as monarch drugs according to the traditional Chinese medicine core pathogenesis of 'spleen qi deficiency, dampness accumulation and heat, blood wave and liver' of chronic colitis; in the formula, the codonopsis pilosula has the functions of tonifying spleen and lung, the amomum cardamomum has the functions of eliminating dampness and promoting qi circulation, and is a key medicine for treating dampness obstruction and qi stagnation and spleen-stomach disharmony, the codonopsis pilosula and the amomum cardamomum are combined to tonify qi and invigorate spleen to treat the root cause, the amomum cardamomum has the functions of promoting qi circulation and eliminating dampness to treat the root cause, and the amom. Coptis root, rhizoma Coptidis, radix Saposhnikoviae, fructus mume; halloysitum rubrum is used as a guiding drug to enter the large intestine. The medicines are combined to play the effects of invigorating spleen and replenishing qi, promoting diuresis and clearing heat, and relieving diarrhea with astringents.
Modern research on this party has confirmed that: the atractylis ovata mainly contains volatile oil and polysaccharide components, wherein lactone components in the volatile oil have the effects of resisting inflammation, regulating immunity, improving gastrointestinal tract function and promoting nutrient absorption, and especially have remarkable effect on atractylenolide I. Meanwhile, the bighead atractylodes rhizome can promote the proliferation of gastric mucosal cells, stimulate the secretion of pepsin and has a strong effect of preventing stress ulcer. Radix Codonopsis contains various saccharides, phenols, sterols, saponins and trace alkaloids, and has effects of enhancing immunity, improving microcirculation and improving hemopoiesis. The amomum cardamomum contains various volatile oil components, can promote gastric secretion, enhance gastrointestinal peristalsis, prevent intestinal abnormal fermentation, remove gastrointestinal qi accumulation and has good aromatic stomach invigorating effect. Alkaloid components such as berberine in Coptidis rhizoma have broad pharmacological activities of resisting bacteria and inflammation, inhibiting platelet aggregation, lowering blood sugar and resisting arrhythmia. Has obvious inhibiting effect on mouse ulcerative colitis induced by dextral dextran sulfate, can reduce the mouse colitis symptom in a dose-dependent manner, prevent the pathological change of a colon mucous membrane, reduce the MDA content of a colon tissue, increase the MPO activity and the SOD activity, and has the curative effect equivalent to that of sulfasalazine. The divaricate saposhnikovia root mainly contains volatile oil, chromone, coumarins, polysaccharide and other components, the extract of the divaricate saposhnikovia root has the effects of resisting bacteria, inflammation, allergy, bleeding and immunoregulation and the like, the organic acid components in the dark plum have obvious antibacterial and antiallergic effects, and the components have good inhibitory effects on symptoms such as bleeding, abdominal pain, diarrhea and the like caused by chronic colitis. The formula is complete, the compatibility is reasonable, and the traditional Chinese medicine has an obvious treatment effect on chronic colitis patients who are not cured for a long time and have recurrent attacks. The research result of the modern pharmacy with clear medicines in the prescription provides a solid experimental basis for preparing the prescription into a new Chinese medicinal compound preparation which meets the requirements of modern life by adopting the modern preparation process.
Aiming at the defects that the traditional Chinese medicine granule for treating chronic colitis has large dosage (20 g/time, 3 times per day), contains a large amount of sugar, is not suitable for the requirements of special crowds such as diabetes and the like, has rough existing quality standard, poor preparation stability and the like, the modern preparation process is adopted, and the traditional Chinese medicine granule is developed into six types of new traditional Chinese medicines which are convenient to take and carry, wide in application range, good in stability and the like and meet the requirements of modern life and social development, and has good social and economic benefits.
The invention provides a traditional Chinese medicine granule for treating chronic colitis, which is prepared from the following raw material medicines in parts by weight: 150 portions of largehead atractylodes rhizome, 100 portions of pilose asiabell root, 120 portions of cardamom, 90 portions to 120 portions of white cardamom, 75 portions to 100 portions of coptis root, 60 portions to 90 portions of divaricate saposhnikovia root, 75 portions to 100 portions of dark plum fruit and 240 portions of red halloysite.
Further, the preparation method of the traditional Chinese medicine granule for treating chronic colitis comprises the following steps:
(A) pulverizing the raw material extract dry extract into fine powder, sieving with 100 mesh sieve, placing lactose and dry extract powder in a fluidizing chamber of a fluidized bed, and regulating air flow until the material is boiled;
(B) spraying after preheating the materials, starting an atomizer when the temperature of the materials reaches 40 ℃, selecting HPMC with the concentration of 5% as a bonding agent, adjusting the pressure of the atomizer to 0.1MPa, and spraying the bonding agent into a fluidization chamber for granulation;
(C) the rotating speed of the fan is adjusted to 1700rpm, the temperature of inlet air is 65 ℃, and the feeding speed of the peristaltic pump is 4 → 6 → 8 HZ;
(D) after the particles are formed, continuously drying the particles by using hot air at 50 ℃, taking out the particles after about 0.5 hour, weighing the particles, respectively sieving the particles by using a No. 1 sieve and a No. 5 sieve, finally finishing and collecting the particles which can pass through the No. 1 sieve but cannot pass through the No. 5 sieve, and subpackaging to obtain the granules.
Further, the preparation method of the raw material extract dry extract in the step (A) comprises the following steps:
a. weighing Atractylodes macrocephala, radix Codonopsis, fructus Amomi rotundus, Coptidis rhizoma, radix Saposhnikoviae, mume fructus, and Halloysitum rubrum at a certain ratio, adding distilled water 10 times of the medicinal materials, and decocting for 2 times for 1 hr each time;
b. filtering the decoction, concentrating the filtrate to obtain a concentrate with a relative density of 1: 1.08-1.10, cooling to room temperature, adding 95% ethanol to adjust the ethanol precipitation concentration to 70%;
c. standing at 4 ℃ for 24 hours, filtering, concentrating the filtrate under reduced pressure to recover ethanol, and concentrating to obtain the extract with the relative density of 1: 1.25-1.30 of extractum;
d. drying at 60 deg.C under 1Mpa to obtain extract dry extract.
In a second aspect of the invention, an application of the above traditional Chinese medicine granules for treating chronic colitis in preparation of a medicine or health food for preventing or treating chronic colitis is provided.
The invention has the advantages that:
1. pharmacodynamic experiments show that the traditional Chinese medicine composition has a remarkable treatment effect on chronic ulcerative colitis animal models. Clinical tests show that the effective rate of treating chronic ulcerative colitis is 95%, the effective rate of treating chronic non-ulcerative colitis is 90%, and the clinical tests show that the effective rate of treating chronic ulcerative colitis is 95% and has obvious statistical difference compared with a control group;
2. the invention is clinically used for treating chronic colitis, has obvious curative effect, does not have serious adverse reaction, and is safe and reliable;
3. the invention provides a new effective medicine for the traditional Chinese medicine treatment of chronic colitis, enriches the research content of the traditional Chinese medicine pharmaceutics, and provides a reference for a method for converting the traditional Chinese medicine hospital preparation into a new medicine.
Detailed Description
The following examples are provided to illustrate specific embodiments of the present invention.
Example 1:
a traditional Chinese medicine granule for treating chronic colitis is prepared from the following raw material medicines in parts by weight: 150 parts of bighead atractylodes rhizome, 100 parts of codonopsis pilosula, 90 parts of amomum cardamomum, 75 parts of coptis chinensis, 60 parts of divaricate saposhnikovia root, 75 parts of dark plum fruit and 200 parts of red halloysite.
Example 2:
a traditional Chinese medicine granule for treating chronic colitis is prepared from the following raw material medicines in parts by weight: 200 parts of bighead atractylodes rhizome, 120 parts of codonopsis pilosula, 120 parts of amomum cardamomum, 100 parts of coptis chinensis, 90 parts of divaricate saposhnikovia root, 100 parts of dark plum fruit and 240 parts of red halloysite.
Example 3:
a traditional Chinese medicine granule for treating chronic colitis is prepared from the following raw material medicines in parts by weight: 160 parts of largehead atractylodes rhizome, 105 parts of codonopsis pilosula, 95 parts of amomum cardamomum, 80 parts of coptis chinensis, 65 parts of divaricate saposhnikovia root, 80 parts of dark plum fruit and 210 parts of red halloysite.
Example 4:
a traditional Chinese medicine granule for treating chronic colitis is prepared from the following raw material medicines in parts by weight: 170 parts of bighead atractylodes rhizome, 110 parts of codonopsis pilosula, 100 parts of amomum cardamomum, 85 parts of coptis chinensis, 70 parts of divaricate saposhnikovia root, 85 parts of dark plum fruit and 220 parts of red halloysite.
Example 5:
a traditional Chinese medicine granule for treating chronic colitis is prepared from the following raw material medicines in parts by weight: 180 parts of bighead atractylodes rhizome, 115 parts of codonopsis pilosula, 110 parts of amomum cardamomum, 90 parts of coptis chinensis, 75 parts of divaricate saposhnikovia root, 90 parts of dark plum fruit and 230 parts of red halloysite.
Example 6:
a traditional Chinese medicine granule for treating chronic colitis is prepared from the following raw material medicines in parts by weight: 190 parts of bighead atractylodes rhizome, 118 parts of codonopsis pilosula, 115 parts of amomum cardamomum, 95 parts of coptis chinensis, 80 parts of divaricate saposhnikovia root, 95 parts of dark plum fruit and 225 parts of red halloysite.
Example 7: the traditional Chinese medicine compound extract
Weighing 300g of bighead atractylodes rhizome, 200g of codonopsis pilosula, 180g of amomum cardamomum, 150g of coptis chinensis, 120g of divaricate saposhnikovia root, 150g of dark plum fruit and 400g of red halloysite, adding 10 times of water for decocting for 2 times, wherein the decocting time is 1 hour each time, merging decoction, filtering, concentrating the filtrate until the relative density is 1: 1.08-1.10 (90-95 ℃), cooling to room temperature, adding 95% ethanol to adjust the alcohol concentration of the solution to 70%, standing for 24 hours at 4 ℃, filtering, concentrating the filtrate under reduced pressure to recover the ethanol, concentrating into an extract with the relative density of 1: 1.25-1.30(50-60 ℃), and drying under reduced pressure at 60 ℃ and 1Mpa to obtain an extract dry.
Example 8: preparation of the granules of the invention
The dry extract of the extract obtained in example 7 was pulverized to fine powder, sieved through a 100 mesh sieve, and 20g of lactose and 200g of dry extract powder were weighed into a fluidizing chamber of a fluidized bed, and the air flow was adjusted until the material was boiled. Spraying can be started after the materials are preheated, namely, after the temperature of the materials reaches 40 ℃, an atomizer is started, HPMC with the mass concentration of 5% is selected as a bonding agent, the pressure of the atomizer is adjusted to 0.1MPa, the bonding agent is sprayed into a fluidization chamber for granulation, and granulation is carried out. The rotating speed frequency of the fan is adjusted to 1700rpm, the temperature of the inlet air is set to 65 ℃, and the speed of the peristaltic pump is set to 4 → 6 → 8Hz (each speed is kept for 10 minutes and is adjusted to the next rotating speed, and the speed is kept unchanged until the preparation is finished after the highest rotating speed is reached). After the particles are formed, the particles are dried by hot air at 50 ℃, after about 0.5 hour, the particles are taken out and weighed, the particles are respectively sieved by a No. 1 sieve and a No. 5 sieve, and finally, the particles which can be sieved by the No. 1 sieve but can not be sieved by the No. 5 sieve are sorted and collected. Subpackaging to obtain the final product.
Example 9: clinical trial
60 patients with chronic colitis were treated with the granules prepared in example 8, and their efficacy and safety were observed. Of these, 36 men and 24 women were randomized into 3 groups, namely, chronic ulcerative colitis-treated group, chronic non-ulcerative colitis-treated group, and control group, with 20 persons each. The two treatment groups of patients take the traditional Chinese medicine compound extract granules prepared in the embodiment 8 orally, the granular preparation used in the control group is a blank granular preparation, namely the granular preparation does not contain the traditional Chinese medicine compound extract, the lactose and the dextrin with the same proportion are added with caramel edible coloring agent to prepare the granules into the granular preparation with the same appearance and taste as the granular preparation prepared in the embodiment 8, the oral administration is carried out, the administration is carried out 2 times a day, 6g is carried out each time, and the treatment course is 8 weeks. The recovery condition of the patient is integrally evaluated and divided into 3 levels of obvious effect, improvement and ineffectiveness. The results are shown in Table 1.
TABLE 1 evaluation Table for the improvement of the overall therapeutic effect of 8 weeks of treatment
The effective rate is as follows: (number of significant cases + number of good cases)/number of all cases × 100%
After 8 weeks of treatment, the effective rate of treating chronic ulcerative colitis is 95%, the effective rate of treating chronic non-ulcerative colitis is 90%, the effective rate of the control group is 25%, and the treatment group is obviously superior to the control group.
The two treatment groups have 3 cases of mild nausea, abdominal distension or discomfort, the control group has no adverse reaction, and the comparison between the groups has no statistical difference, which indicates that the granule of the invention has good safety.
Example 10 study of the formulation compatibility
The compatibility dosage of the medicine of the prescription is screened by adopting a pharmacodynamics research method.
1. Laboratory animal
Healthy male SD rats, clean grade, weighing 180-200 g, purchased from the laboratory animal center of the second department of military medical university (animal certification number: SCXK2017-0003), drinking water and eating freely.
2. Reagent
The test samples 1, 2 and 3 with the prescription numbers of 1-3 are prepared from the traditional Chinese medicine raw materials with the compatible dosages in the embodiments 1, 2 and 3 according to the medicinal material extraction process and the granule preparation process in the embodiments 7-8, and pharmacodynamic studies are carried out.
3. Animal grouping and establishment of chronic ulcerative colitis rat model
60 male SD rats were randomly divided into 6 groups, namely a normal control group, a model group, a positive control drug sulfasalazine group, a sample 1, a sample 2 and a sample 3, and 10 rats in each group. After fasting for 24 hours, except for a normal control group, the rats of other groups are modeled, 2% pentobarbital sodium is injected into the abdominal cavity, after the rats are slightly anesthetized, a latex tube with the diameter of 2mm is gently inserted into the body of the rats by an anus for about 8cm, a modeling agent TNBS is dissolved in 50% ethanol water solution, the TNBS solution is injected into the intestinal cavity of the rats at one time by a syringe, the TNBS dosage is 100mg/kg according to the body weight, the tail of the rats is lifted and inverted for 30 seconds, the modeling agent is prevented from leaking, and the modeling agent is made to fully permeate into the intestinal cavity of the rats.
4. Administration method and evaluation index
The drug administration is started 6h after the molding, and is continuously carried out for 10 days once a day. The administration groups are respectively administrated by intragastric administration for 2ml each day; rats in the normal control group and the model group were gazed with the same volume of physiological saline daily. And respectively observing the influence of different sample groups on the weight change, diarrhea and hematochezia of the rats with the chronic ulcerative colitis model.
After the rats in each group are administered for 10 days, the rats are killed by injecting excessive sodium pentobarbital, the abdomens of the rats are cut open, and the intestinal tracts are observed to be generally changed. The last colon 10cm from the anus was removed, slit longitudinally along the mesentery, rinsed with ice physiological saline, and weighed after drying with filter paper. Mucosa was spread face up, mucosal lesions were observed and scored according to Wallace and Keenan1990 scoring criteria: 0 point, no inflammation and ulcer; 1 point, local congestion without ulcer; 2 points, ulcer but no congestion; 3 points, one part of ulcer and inflammation; ulcer and inflammation at 4 min, at two or more parts; and 5 points, the ulcer extends over 2 cm.
5. Results of the experiment
5.1 Effect of sample particles of different proportions on weight change of rats with chronic ulcerative colitis model
The normal control group rats gradually returned to the original body weight after slight weight loss due to fasting for 1d, and gradually increased to 115% of the original body weight. The weight of the TNBS model group rats is rapidly reduced after modeling, reduced to 86% of the original weight at 2d, the weight in the body is significantly lower than that of the normal group rats (P <0.05) at 1-7 d, the weight of the rats in the sample 1, the sample 3 and the positive control group in the 3 groups of samples is recovered faster, the weight is gradually recovered to the original weight at 5-6 d, and the weight of the rats in the 1-7 d is significantly higher than that of the model rats (P < 0.05).
5.2 Effect of sample particles with different proportions on diarrhea and hematochezia of rats with chronic ulcerative colitis models
The number of rats with diarrhea and hematochezia in 1, 3, 5 and 7 days in each group is shown in table 2. The rats in the normal control group did not have diarrhea and hematochezia, and the rats after TNBS molding showed disorder and lusterless hair color, listlessness and listlessness, and diarrhea and hematochezia of different degrees appeared in the 1 st day. However, the number of the rats in the model group suffered from diarrhea and hematochezia within 7d is significantly larger than that in the sample group and the positive control group. The 3 groups of samples and the positive control drug have inhibitory effect on diarrhea and hematochezia of the model rats, wherein the effect of the 1 group of samples is equivalent to that of the positive control drug.
TABLE 2 Effect of sample particles on diarrhea and hematochezia in rats model for chronic ulcerative colitis (n ═ 10)
5.3 Effect of sample particles on Colon Damage score in rats model for Chronic ulcerative colitis
The appearance of the colon and the mucous membrane surface of the colon after the rat is dissected are observed, the colon of the model group rat is mostly slightly adhered to the adjacent visceral organs, the colon is congested and edematous, a large ulcerative focus is formed at the position 8cm above the anal orifice, the colon wall at the focus is thickened, and the intestinal mucous membrane surface is subjected to ulcer erosion necrosis, so that the colon is obviously shortened compared with the normal group rat. The 3 samples and the positive control group can improve the inflammatory symptoms such as the congestion and the edema of the colon, reduce the ulcer area, reduce the colon weight and reduce the colon damage score of a model rat (P <0.05), and the results are shown in the table 3.
TABLE 3 particles of samples versus chronic ulcerative colitis modelEffect of Colon Damage score in type rats
P <0.05 vs TNBS model group; p < 0.01vs TNBS model group
The results of the study showed that sample 1 (example 1) had the best pharmacodynamic action, comparable to the positive control.
Example 11 clinical observations
In order to further investigate the clinical application effect of the compatibility of the formula, the clinical effect of the formula of the invention is compared and observed with the formula reported in documents.
1. Method of producing a composite material
Test group drug composition: 30g of bighead atractylodes rhizome, 20g of codonopsis pilosula, 18g of amomum cardamomum, 15g of coptis chinensis, 12g of divaricate saposhnikovia root, 15g of dark plum fruit and 40g of red halloysite;
the drug composition of the control group is as follows: 30g of bighead atractylodes rhizome, 15g of coptis root, 12g of divaricate saposhnikovia root and 15g of dark plum fruit.
The two prescriptions are decocted in water by conventional method and administered orally.
60 patients with chronic colitis were selected, 32 men and 28 women, and were randomly divided into two groups, test and control groups. The water decoctions of the test group and the control group are orally administered to two groups of patients respectively, once every day, in the morning and at night, and are continuously administered for one week and then stopped for one day. The clinical effects and incidence of adverse reactions of the two groups of drugs were examined 8 weeks after administration.
2. Results
Both groups of medicines have good treatment effect on patients with chronic colitis, the effective rate of the test group is 93.4%, and the effective rate of the control group is 86.6%. In the test group, 1 patient has mild abdominal distension; in the control group, 2 patients showed nausea and 2 patients showed diarrhea. The incidence of adverse reactions in the test group (3.33%) was lower than that in the control group (13.3%).
TABLE 4 evaluation Table for improvement of overall therapeutic effect at 8 weeks of treatment
Effective rate (number of significant cases + number of good cases)/number of all cases × 100%.
While the preferred embodiments of the present invention have been described in detail, it will be understood by those skilled in the art that the invention is not limited thereto, and that various changes and modifications may be made without departing from the spirit of the invention, and the scope of the appended claims is to be accorded the full range of equivalents.
Claims (5)
1. The traditional Chinese medicine granule for treating chronic colitis is characterized by being prepared from the following raw material medicines in parts by weight: 150 portions of largehead atractylodes rhizome, 100 portions of pilose asiabell root, 120 portions of cardamom, 90 portions to 120 portions of white cardamom, 75 portions to 100 portions of coptis root, 60 portions to 90 portions of divaricate saposhnikovia root, 75 portions to 100 portions of dark plum fruit and 240 portions of red halloysite.
2. The traditional Chinese medicine granule for treating chronic colitis according to claim 1, which is prepared from the following raw material medicines in parts by weight: 150 parts of bighead atractylodes rhizome, 100 parts of codonopsis pilosula, 90 parts of amomum cardamomum, 75 parts of coptis chinensis, 60 parts of divaricate saposhnikovia root, 75 parts of dark plum fruit and 200 parts of red halloysite.
3. The traditional Chinese medicine granule for treating chronic colitis according to claim 1, wherein the preparation method of the granule comprises the following steps:
(A) pulverizing the raw material extract dry extract into fine powder, sieving with 100 mesh sieve, placing lactose and dry extract powder in a fluidizing chamber of a fluidized bed, and regulating air flow until the material is boiled;
(B) spraying after preheating the materials, starting an atomizer when the temperature of the materials reaches 40 ℃, selecting HPMC with the concentration of 5% as a bonding agent, adjusting the pressure of the atomizer to 0.1MPa, and spraying the bonding agent into a fluidization chamber for granulation;
(C) adjusting the rotating speed of a fan to 1700rpm, the temperature of inlet air to 65 ℃, and the feeding speed of a peristaltic pump to be 4, 6 and 8HZ in sequence;
(D) after the particles are formed, continuously drying the particles by using hot air at 50 ℃, taking out the particles after about 0.5 hour, weighing the particles, respectively sieving the particles by using a No. 1 sieve and a No. 5 sieve, finally finishing and collecting the particles which can pass through the No. 1 sieve but cannot pass through the No. 5 sieve, and subpackaging to obtain the granules.
4. The traditional Chinese medicine granule for treating chronic colitis according to claim 3, wherein the preparation method of the raw material extract dry extract in step A comprises the following steps:
a. weighing Atractylodes macrocephala, radix Codonopsis, fructus Amomi rotundus, Coptidis rhizoma, radix Saposhnikoviae, mume fructus, and Halloysitum rubrum at a certain ratio, adding distilled water 10 times of the medicinal materials, and decocting for 2 times for 1 hr each time;
b. filtering the decoction, concentrating the filtrate to obtain a concentrate with a relative density of 1: 1.08-1.10, cooling to room temperature, adding 95% ethanol to adjust the ethanol precipitation concentration to 70%;
c. standing at 4 ℃ for 24 hours, filtering, concentrating the filtrate under reduced pressure to recover ethanol, and concentrating to obtain the extract with the relative density of 1: 1.25-1.30 of extractum;
d. drying at 60 deg.C under 1Mpa to obtain extract dry extract.
5. Use of the traditional Chinese medicine granules for treating chronic colitis according to any one of claims 1 to 4 in the preparation of a medicament for treating chronic colitis.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810782877.9A CN108815448B (en) | 2018-07-17 | 2018-07-17 | Traditional Chinese medicine granules for treating chronic colitis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810782877.9A CN108815448B (en) | 2018-07-17 | 2018-07-17 | Traditional Chinese medicine granules for treating chronic colitis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN108815448A CN108815448A (en) | 2018-11-16 |
| CN108815448B true CN108815448B (en) | 2021-04-30 |
Family
ID=64140646
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810782877.9A Active CN108815448B (en) | 2018-07-17 | 2018-07-17 | Traditional Chinese medicine granules for treating chronic colitis |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108815448B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111494403A (en) * | 2019-01-31 | 2020-08-07 | 成都中医药大学 | Application of atractylodes macrocephala polysaccharide in preparing medicine for preventing and treating ulcerative colitis |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102085252A (en) * | 2011-01-21 | 2011-06-08 | 中国人民解放军第二军医大学 | Pharmaceutical composition for treating ulcerative colitis and colon-targeted micro-pill preparation thereof |
| CN103784848A (en) * | 2014-01-15 | 2014-05-14 | 中国人民解放军第二军医大学 | Traditional Chinese medicinal composition for treating chronic colitis and preparation and application thereof |
-
2018
- 2018-07-17 CN CN201810782877.9A patent/CN108815448B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102085252A (en) * | 2011-01-21 | 2011-06-08 | 中国人民解放军第二军医大学 | Pharmaceutical composition for treating ulcerative colitis and colon-targeted micro-pill preparation thereof |
| CN103784848A (en) * | 2014-01-15 | 2014-05-14 | 中国人民解放军第二军医大学 | Traditional Chinese medicinal composition for treating chronic colitis and preparation and application thereof |
Non-Patent Citations (1)
| Title |
|---|
| 用流化制粒技术制备的愈肠颗粒的药效学研究;邵雪庆等;《药学服务与研究》;20180430(第2期);104-109页 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN108815448A (en) | 2018-11-16 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101711848B (en) | Chinese medicinal composition capable of adjunctively treating tumour | |
| CN104338044A (en) | Drug for treating gynecological abnormal leucorrhea and preparation method thereof | |
| CN104491342A (en) | Medicament for treating diabetes and preparation method thereof | |
| CN108815448B (en) | Traditional Chinese medicine granules for treating chronic colitis | |
| CN101564464B (en) | Chinese medicament for adjusting organism immunity of tumor patients | |
| CN103977370A (en) | Pharmaceutical composition with effect of inducing diuresis to alleviate edema | |
| CN103417911A (en) | Traditional Chinese medicine composition for supporting chemo-treatment | |
| CN102274428B (en) | Pharmaceutical composition with effect on treating irritable bowel syndrome and preparation method and application thereof | |
| CN106563076B (en) | Medicine for treating stomach disease and its preparing method | |
| CN103520684A (en) | Traditional Chinese medicine compound for reducing blood sugar | |
| CN116440224B (en) | Traditional Chinese medicine composition, preparation and preparation method | |
| CN103341108B (en) | Pharmaceutical composite for treating stress urinary incontinence after prostatectomy | |
| CN103191339B (en) | Method for preparing drug for treating pediatric esophageal achalasia | |
| CN101167915B (en) | Traditional Chinese medicine for treating chronic superficial gastritis and its preparation method | |
| CN102552423B (en) | Medicinal composition for treating migraine | |
| CN107213443B (en) | Traditional Chinese medicine composition for treating hydronephrosis and combined application of thunder-fire moxibustion | |
| CN105148090A (en) | Traditional Chinese medicine preparation for nursing throat and lung diseases | |
| CN1189207C (en) | Chinese medicinal composition for improving human immunity and its preparation method | |
| CN104784563A (en) | Traditional Chinese medicine preparation for treating amygdalitis and preparation method thereof | |
| CN104784567B (en) | A kind of pharmaceutical composition for the treatment of urinary system infection | |
| CN104306585A (en) | Traditional Chinese medicine combination for curing prostatitis, and preparation method and application thereof | |
| CN104491561A (en) | Medicine used for treating pneumonia and preparation method of medicine | |
| CN113797307A (en) | Traditional Chinese medicine preparation for chronic gastroenteritis, preparation method and taking method thereof | |
| CN103566351B (en) | Traditional Chinese medicine preparation for treating infantile diarrhea | |
| CN103301378B (en) | Pharmaceutical composition for treating nocturia of children |
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 | ||
| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20230427 Address after: 215100 C30, bio nano technology park, 218 Xinghu street, Suzhou Industrial Park, Jiangsu Province Patentee after: SUZHOU YOUSEEN NEW DRUG R & D Co.,Ltd. Address before: 200127 No. 270, Dong'an Road, Xuhui District, Shanghai Patentee before: FUNDAN University SHANGHAI CANCER CENTER |