CN115192684B - 一种用于减轻或治疗疼痛的中药组合物及其制备方法 - Google Patents
一种用于减轻或治疗疼痛的中药组合物及其制备方法 Download PDFInfo
- Publication number
- CN115192684B CN115192684B CN202210892316.0A CN202210892316A CN115192684B CN 115192684 B CN115192684 B CN 115192684B CN 202210892316 A CN202210892316 A CN 202210892316A CN 115192684 B CN115192684 B CN 115192684B
- Authority
- CN
- China
- Prior art keywords
- parts
- traditional chinese
- chinese medicine
- pain
- weight
- 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
- 208000002193 Pain Diseases 0.000 title claims abstract description 56
- 230000036407 pain Effects 0.000 title claims abstract description 54
- 239000000203 mixture Substances 0.000 title claims abstract description 29
- 238000002360 preparation method Methods 0.000 title description 40
- 239000003814 drug Substances 0.000 claims abstract description 43
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 claims abstract description 21
- 241000218176 Corydalis Species 0.000 claims abstract description 21
- 239000004863 Frankincense Substances 0.000 claims abstract description 21
- REPVLJRCJUVQFA-UHFFFAOYSA-N (-)-isopinocampheol Natural products C1C(O)C(C)C2C(C)(C)C1C2 REPVLJRCJUVQFA-UHFFFAOYSA-N 0.000 claims abstract description 20
- 235000003717 Boswellia sacra Nutrition 0.000 claims abstract description 20
- 240000007551 Boswellia serrata Species 0.000 claims abstract description 20
- 235000012035 Boswellia serrata Nutrition 0.000 claims abstract description 20
- 241000131329 Carabidae Species 0.000 claims abstract description 20
- 240000007311 Commiphora myrrha Species 0.000 claims abstract description 20
- 235000006965 Commiphora myrrha Nutrition 0.000 claims abstract description 20
- 244000163122 Curcuma domestica Species 0.000 claims abstract description 20
- 235000007265 Myrrhis odorata Nutrition 0.000 claims abstract description 20
- 229940116229 borneol Drugs 0.000 claims abstract description 20
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 claims abstract description 20
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 claims abstract description 20
- 235000003392 Curcuma domestica Nutrition 0.000 claims abstract description 19
- 241000208296 Datura Species 0.000 claims abstract description 19
- 235000003373 curcuma longa Nutrition 0.000 claims abstract description 19
- 235000013976 turmeric Nutrition 0.000 claims abstract description 19
- 206010058019 Cancer Pain Diseases 0.000 claims abstract description 16
- 239000000843 powder Substances 0.000 claims description 43
- 235000008671 Calycanthus floridus Nutrition 0.000 claims description 18
- 235000008670 Calycanthus occidentalis Nutrition 0.000 claims description 18
- 244000148992 Lindera benzoin Species 0.000 claims description 18
- 235000004520 Lindera benzoin Nutrition 0.000 claims description 18
- 235000008262 Lindera benzoin var. benzoin Nutrition 0.000 claims description 18
- 239000002994 raw material Substances 0.000 claims description 7
- 239000002552 dosage form Substances 0.000 claims description 5
- 235000003351 Brassica cretica Nutrition 0.000 claims description 4
- 235000003343 Brassica rupestris Nutrition 0.000 claims description 4
- QKSKPIVNLNLAAV-UHFFFAOYSA-N bis(2-chloroethyl) sulfide Chemical compound ClCCSCCCl QKSKPIVNLNLAAV-UHFFFAOYSA-N 0.000 claims description 4
- 235000010460 mustard Nutrition 0.000 claims description 4
- 244000056139 Brassica cretica Species 0.000 claims 3
- 244000241463 Cullen corylifolium Species 0.000 claims 1
- 235000013399 edible fruits Nutrition 0.000 claims 1
- 235000019508 mustard seed Nutrition 0.000 abstract description 16
- 230000000694 effects Effects 0.000 abstract description 12
- 206010067484 Adverse reaction Diseases 0.000 abstract description 4
- 230000006838 adverse reaction Effects 0.000 abstract description 4
- 229940126680 traditional chinese medicines Drugs 0.000 abstract description 2
- 230000000202 analgesic effect Effects 0.000 abstract 1
- 238000000227 grinding Methods 0.000 description 16
- 239000000463 material Substances 0.000 description 16
- 241000699670 Mus sp. Species 0.000 description 12
- 230000000052 comparative effect Effects 0.000 description 11
- PJMPHNIQZUBGLI-UHFFFAOYSA-N fentanyl Chemical compound C=1C=CC=CC=1N(C(=O)CC)C(CC1)CCN1CCC1=CC=CC=C1 PJMPHNIQZUBGLI-UHFFFAOYSA-N 0.000 description 10
- 229960002428 fentanyl Drugs 0.000 description 10
- 206010028980 Neoplasm Diseases 0.000 description 8
- 238000002474 experimental method Methods 0.000 description 8
- 229940079593 drug Drugs 0.000 description 6
- 239000011159 matrix material Substances 0.000 description 6
- 230000035484 reaction time Effects 0.000 description 6
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 5
- 238000006243 chemical reaction Methods 0.000 description 5
- 230000003285 pharmacodynamic effect Effects 0.000 description 5
- 238000000034 method Methods 0.000 description 4
- 210000005036 nerve Anatomy 0.000 description 4
- 210000000056 organ Anatomy 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 206010065390 Inflammatory pain Diseases 0.000 description 3
- 210000000988 bone and bone Anatomy 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 230000003902 lesion Effects 0.000 description 3
- 230000003340 mental effect Effects 0.000 description 3
- 208000004296 neuralgia Diseases 0.000 description 3
- 208000021722 neuropathic pain Diseases 0.000 description 3
- 230000000472 traumatic effect Effects 0.000 description 3
- 238000011282 treatment Methods 0.000 description 3
- 208000004454 Hyperalgesia Diseases 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- 206010058467 Lung neoplasm malignant Diseases 0.000 description 2
- 206010061902 Pancreatic neoplasm Diseases 0.000 description 2
- 206010041349 Somnolence Diseases 0.000 description 2
- 208000005718 Stomach Neoplasms Diseases 0.000 description 2
- 229960000583 acetic acid Drugs 0.000 description 2
- 229940035676 analgesics Drugs 0.000 description 2
- 238000010171 animal model Methods 0.000 description 2
- 239000000730 antalgic agent Substances 0.000 description 2
- 210000004556 brain Anatomy 0.000 description 2
- 201000011510 cancer Diseases 0.000 description 2
- 206010017758 gastric cancer Diseases 0.000 description 2
- 235000012907 honey Nutrition 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 230000009545 invasion Effects 0.000 description 2
- 201000007270 liver cancer Diseases 0.000 description 2
- 208000014018 liver neoplasm Diseases 0.000 description 2
- 201000005202 lung cancer Diseases 0.000 description 2
- 208000020816 lung neoplasm Diseases 0.000 description 2
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 description 2
- 201000002528 pancreatic cancer Diseases 0.000 description 2
- 208000008443 pancreatic carcinoma Diseases 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 239000002504 physiological saline solution Substances 0.000 description 2
- 208000020016 psychiatric disease Diseases 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 239000008159 sesame oil Substances 0.000 description 2
- 235000011803 sesame oil Nutrition 0.000 description 2
- 201000011549 stomach cancer Diseases 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 230000000451 tissue damage Effects 0.000 description 2
- 231100000827 tissue damage Toxicity 0.000 description 2
- RSWGJHLUYNHPMX-UHFFFAOYSA-N Abietic-Saeure Natural products C12CCC(C(C)C)=CC2=CCC2C1(C)CCCC2(C)C(O)=O RSWGJHLUYNHPMX-UHFFFAOYSA-N 0.000 description 1
- 206010002556 Ankylosing Spondylitis Diseases 0.000 description 1
- 206010003840 Autonomic nervous system imbalance Diseases 0.000 description 1
- 241000717739 Boswellia sacra Species 0.000 description 1
- 241000219198 Brassica Species 0.000 description 1
- 235000014375 Curcuma Nutrition 0.000 description 1
- 208000032131 Diabetic Neuropathies Diseases 0.000 description 1
- 201000011275 Epicondylitis Diseases 0.000 description 1
- 241001489978 Eupolyphaga Species 0.000 description 1
- 241000628997 Flos Species 0.000 description 1
- 208000035154 Hyperesthesia Diseases 0.000 description 1
- 208000004404 Intractable Pain Diseases 0.000 description 1
- 238000012449 Kunming mouse Methods 0.000 description 1
- 206010024453 Ligament sprain Diseases 0.000 description 1
- 206010027476 Metastases Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 241000699666 Mus <mouse, genus> Species 0.000 description 1
- 241001057584 Myrrha Species 0.000 description 1
- 206010028851 Necrosis Diseases 0.000 description 1
- 206010030216 Oesophagitis Diseases 0.000 description 1
- 208000006735 Periostitis Diseases 0.000 description 1
- 206010036376 Postherpetic Neuralgia Diseases 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- KHPCPRHQVVSZAH-HUOMCSJISA-N Rosin Natural products O(C/C=C/c1ccccc1)[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 KHPCPRHQVVSZAH-HUOMCSJISA-N 0.000 description 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 1
- 208000032140 Sleepiness Diseases 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- RSWGJHLUYNHPMX-ONCXSQPRSA-N abietic acid Chemical compound C([C@@H]12)CC(C(C)C)=CC1=CC[C@@H]1[C@]2(C)CCC[C@@]1(C)C(O)=O RSWGJHLUYNHPMX-ONCXSQPRSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 231100000215 acute (single dose) toxicity testing Toxicity 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 208000005298 acute pain Diseases 0.000 description 1
- 238000011047 acute toxicity test Methods 0.000 description 1
- 206010053552 allodynia Diseases 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 208000006990 cholangiocarcinoma Diseases 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- VFLDPWHFBUODDF-FCXRPNKRSA-N curcumin Chemical compound C1=C(O)C(OC)=CC(\C=C\C(=O)CC(=O)\C=C\C=2C=C(OC)C(O)=CC=2)=C1 VFLDPWHFBUODDF-FCXRPNKRSA-N 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 208000006881 esophagitis Diseases 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000000556 factor analysis Methods 0.000 description 1
- 210000003195 fascia Anatomy 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000012362 glacial acetic acid Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000010832 independent-sample T-test Methods 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 206010022437 insomnia Diseases 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 208000028867 ischemia Diseases 0.000 description 1
- 210000003041 ligament Anatomy 0.000 description 1
- 231100001252 long-term toxicity Toxicity 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000009401 metastasis Effects 0.000 description 1
- 230000001394 metastastic effect Effects 0.000 description 1
- 206010061289 metastatic neoplasm Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 201000001119 neuropathy Diseases 0.000 description 1
- 230000007823 neuropathy Effects 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 210000003460 periosteum Anatomy 0.000 description 1
- 208000033808 peripheral neuropathy Diseases 0.000 description 1
- 239000011505 plaster Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- 210000000582 semen Anatomy 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 230000037321 sleepiness Effects 0.000 description 1
- 210000000278 spinal cord Anatomy 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- KHPCPRHQVVSZAH-UHFFFAOYSA-N trans-cinnamyl beta-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OCC=CC1=CC=CC=C1 KHPCPRHQVVSZAH-UHFFFAOYSA-N 0.000 description 1
- 238000011269 treatment regimen Methods 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 210000005166 vasculature Anatomy 0.000 description 1
- 230000002747 voluntary effect 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)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
-
- 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)
- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
-
- 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)
- A61K36/32—Burseraceae (Frankincense family)
- A61K36/324—Boswellia, e.g. frankincense
-
- 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)
- A61K36/32—Burseraceae (Frankincense family)
- A61K36/328—Commiphora, e.g. mecca myrrh or balm of Gilead
-
- 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
- A61K36/487—Psoralea
-
- 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)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
-
- 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)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Botany (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Insects & Arthropods (AREA)
- Zoology (AREA)
- Animal Husbandry (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
本发明属于中药技术领域,具体涉及一种止痛作用的中药组合物。所述中药组合物由由延胡索18‑25重量份、乌药75‑95重量份、土鳖虫33‑50重量份、姜黄50‑80重量份、补骨脂60‑80重量份、芥子50‑70重量份、乳香35‑50重量份、没药30‑50重量份、洋金花3‑6重量份、冰片2‑3重量份组成。本发明中药组合物具有明显的止疼、镇痛作用,对中、重度癌性疼痛的缓解总有效率可达85.71%、64.26%,可有效用于治疗癌性疼痛,疗效确切可靠,且不良反应发生率低,具有很强的临床实际应用价值。
Description
技术领域
本发明涉及一种中药组合物及其用途、制备方法,属于中药技术领域。
背景技术
疼痛(pain)是人类大脑对机体一定部位组织损伤或可导致组织损伤的刺激作用产生的一种不愉快的主观感觉。疼痛可涉及全身各部位、各系统器官和组织。
疼痛的起因可以分为创伤性疼痛、炎性疼痛、神经病理性疼痛、癌痛和精神(心理)性疼痛等。
1、创伤性疼痛,创伤性疼痛主要是皮肤、肌肉、韧带、筋膜、骨的损伤引起的疼痛,如骨折、急性或慢性腰扭伤、肱骨外上髁炎、烧伤等。
2、炎性疼痛,主要是由于生物源性炎症、化学源性炎症所致的疼痛,如风湿性关节炎、类风湿关节炎、强直性脊柱炎等。
3、神经病理性疼痛,神经病理性疼痛是指发生于神经系统包括周围神经和中枢神经任何部位的神经病变和损害相关的痛觉过敏、痛觉异常所致的疼痛,如带状疱疹后神经痛、糖尿病性神经病变等。
4、癌痛,是由于肿瘤压迫使组织缺血、肿瘤浸润周围器官、神经引起的疼痛,常见于肝癌、胃癌、胰腺癌、胆管癌和恶性肿瘤骨转移的疼痛。
5、精神(心理)性疼,主要是由于心理障碍引起的疼痛,往往无确切的病变和阳性检查结果,患者常主诉周身痛或多处顽固性痛。还可能会伴有其他心理障碍表现,如失眠、多梦、困倦等。
癌性疼痛一般是指由肿瘤直接引起的疼痛,肿瘤侵犯或压迫神经根、神经干、神经丛或神经;侵犯脑和脊髓;肿瘤侵犯骨膜或骨骼;侵犯实质性脏器及空腔性脏器;侵犯或堵塞脉管系统;肿瘤引起局部坏死,溃疡,炎症等;在上述情况下均可导致严重的疼痛。在肿瘤治疗过程中所引起的疼痛,也被认为是癌性疼痛。
发明内容
本发明的目的之一在于提供一种中药组合物,所述的中药组合物主要由延胡索、乌药、土鳖虫、姜黄、补骨脂、芥子、乳香、没药、洋金花、冰片组成。
本发明目的之二在于提供上述中药组合物的具体组成,即所述的中药组合物主要由以下原料组成:
优选的,所述的中药组合物主要由以下原料组成:
进一步优选的,所述的中药组合物主要由以下原料组成:
本发明目的之三在于提供上述中药组合物的用途,即所述的中药组合物在制备减轻或治疗疼痛药物中的用途。
具体的,所述的疼痛包括但不限于创伤性疼痛、炎性疼痛、神经病理性疼痛、癌性疼痛。
优选的,所述的疼痛为癌性疼痛。
进一步优选的,所述的癌性疼痛可以是原发性病灶引起的疼痛和/或转移病灶引起的疼痛。
进一步优选的,所述的癌性疼痛可以是由肺癌、胃癌、胰腺癌、食管炎、肝癌等癌症所引起的疼痛。
更优选的,所述的癌性疼痛为由肺癌引起的疼痛。
本发明目的之四在于提供一种中药制剂,所述的中药制剂由上述含有上述中药组合物或由上述中药组合物制备而成,且为临床上可接受的剂型。
优选的,所述临床上可接受的剂型包括但不限于粉剂、散剂、膏剂。
进一步优选的,所述的临床上可接受的剂型为粉剂。
本发明目的之五在于提供上述粉剂的制备方法,即所述的粉剂的制备方法为:将延胡索、乌药、土鳖虫、姜黄、补骨脂、芥子、乳香、没药、洋金花、冰片,研磨成细粉,加入基质,调成糊状,即可。
优选的,所述的粉剂的制备方法中细粉与基质的比例为1:0.8-2.5。
进一步优选的,所述细粉与基质的比例为1:0.8-1.5。
更优选的,所述细粉与基质的比例为1:1。
上述基质可以是香油、松香、蜂蜜、黄酒中的一种或多种。
优选的,所述基质为蜂蜜。
与现有技术相比,本发明取得了显著的技术效果:
1)药理实验证明,本发明中药组合物及其制剂可以明显减少醋酸所致疼痛小鼠扭体反应次数,具有明显的止疼、镇痛作用。
2)临床试验证实,本发明中药贴剂对中、重度癌性疼痛的缓解总有效率为85.71%、64.26%,可有效用于治疗癌性疼痛,疗效确切可靠,治疗效果优于芬太尼透皮贴组,且不良反应较芬太尼透皮贴组发生率低,具有很强的临床实际应用价值,有巨大的经济和社会效益。
具体实施方式
下面结合具体实施例进一步阐明本发明,应理解这些实施例仅用于说明本发明而不用于限制本发明的范围,在阅读了本发明之后,本领域技术人员对本发明的各种等价形式的修改均落于本申请所附权利要求所限定的范围。
实施例1粉剂制备
延胡索23g、乌药80g、土鳖虫39g、姜黄68g、补骨脂73g、芥子63g、乳香45g、没药40g、洋金花5g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入蜂蜜调和成糊状,即可。
实施例2粉剂制备
延胡索23g、乌药80g、土鳖虫39g、姜黄68g、补骨脂73g、芥子63g、乳香45g、没药40g、洋金花5g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:0.8的比例加入蜂蜜调和成糊状,即可。
实施例3粉剂制备
延胡索23g、乌药80g、土鳖虫39g、姜黄68g、补骨脂73g、芥子63g、乳香45g、没药40g、洋金花5g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:1.5的比例加入蜂蜜调和成糊状,即可。
实施例4粉剂制备
延胡索23g、乌药80g、土鳖虫39g、姜黄68g、补骨脂73g、芥子63g、乳香45g、没药40g、洋金花5g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:2.5的比例加入蜂蜜调和成糊状,即可。
实施例5粉剂制备
延胡索23g、乌药80g、土鳖虫39g、姜黄68g、补骨脂73g、芥子63g、乳香45g、没药40g、洋金花5g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入香油调和成糊状,即可。
实施例6粉剂制备
延胡索23g、乌药80g、土鳖虫39g、姜黄68g、补骨脂73g、芥子63g、乳香45g、没药40g、洋金花5g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入松香调和成糊状,即可。
实施例7粉剂制备
延胡索23g、乌药80g、土鳖虫39g、姜黄68g、补骨脂73g、芥子63g、乳香45g、没药40g、洋金花5g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入黄酒调和成糊状,即可。
实施例8粉剂制备
延胡索23g、乌药78g、土鳖虫43g、姜黄60g、补骨脂75g、芥子55g、乳香48g、没药35g、洋金花6g、冰片2g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入蜂蜜调和成糊状,即可。
实施例9粉剂制备
延胡索20g、乌药83g、土鳖虫35g、姜黄75g、补骨脂68g、芥子65g、乳香40g、没药43g、洋金花3g、冰片3g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入蜂蜜调和成糊状,即可。
实施例10粉剂制备
延胡索25g、乌药75g、土鳖虫50g、姜黄50g、补骨脂80g、芥子50g、乳香50g、没药30g、洋金花6g、冰片2g;
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入蜂蜜调和成糊状,即可。
实施例11粉剂制备
延胡索18g、乌药95g、土鳖虫33g、姜黄80g、补骨脂60g、芥子70g、乳香35g、没药50g、洋金花3g、冰片3g;
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入蜂蜜调和成糊状,即可。
对比实施例1粉剂制备
延胡索30g、乌药60g、土鳖虫80g、姜黄30g、补骨脂100g、芥子80g、乳香30g、没药30g、洋金花3g、冰片1.5g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入蜂蜜调和成糊状,即可。
对比实施例2粉剂制备
延胡索23g、乌药80g、土鳖虫39g、姜黄68g、补骨脂73g、芥子63g、乳香45g、没药40g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入蜂蜜调和成糊状,即可。
对比实施例3粉剂制备
延胡索23g、乌药80g、土鳖虫39g、补骨脂73g、芥子63g、乳香45g、没药40g、洋金花5g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入蜂蜜调和成糊状,即可。
对比实施例4粉剂制备
延胡索23g、乌药80g、土鳖虫39g、姜黄68g、芥子63g、乳香45g、没药40g、洋金花5g、冰片2.8g。
制备方法:取上述药材,研磨成细粉,按照1:1的比例加入蜂蜜调和成糊状,即可。
二、药理学实验
为验证本发明中药组合物在止痛,尤其是减轻癌性疼痛中的作用,发明人开展了相关的药效学试验研究。需要说明的是,下述药效学试验所选取的药品为本发明具有代表性的配方及其制备方法所得的药品;本发明所包含的其它配方及制备方法所得药品,发明人同样进行了药效学实验,实验结果显示其他配方及制备方法所得药品具有相同或类似的效果,但由于篇幅限制,在此不一一穷举。
此外,下述药效学实验仅以部分动物模型为例验证本发明的功效,本发明中提到的其他类型的疼痛或癌性疼痛,发明人亦做了相关药效学实验,实验结果显示,具有相同或类似的效果,在此,不再一一穷举。
发明人要说明的是,以下实验研究均是在急性毒性试验、长期毒性试验证明药物安全性基础之上开展,实验研究中的给药剂量均在安全剂量范围之内。
一、急性疼痛实验
1材料
1.1动物:
昆明种小鼠,SPF级,18~22g,实验动物许可证号:SYXK(鲁)2018 0008,由鲁南制药集团股份有限公司提供,实验前适应性饲养一周。
1.2药物、试剂
1.2.1药物
实施例1、2、5、6、7、8所得粉剂,对比实施例1、2、3、4所得粉剂
1.2.3用药剂量
2.7g/贴
2.造模、分组及给药
取小鼠120只,随机分为空白组、模型组、实施例1、2、5、6、7、8组、对比实施例1、2、3、4组,每组10只;除空白组、模型组外,其余各组取相应的药物贴敷于腹部,固定,空白组、模型组涂擦适量的生理盐水。
3观察指标
3.1扭体反应次数
给药30min后,除空白组外,其余各组小鼠按照10ml/kg腹腔注射0.6%的冰醋酸,空白组腹腔注射等量的生理盐水;观察各组小鼠自出现扭体反应后30min内的扭体反应次数。
3.2统计学处理
采用SPSS22.0软件对所得数据进行统计分析,计量资料用表示,多组间比较采用单因素方差分析,两组间采用独立样本T检验方式分析。以P<0.05为差异有统计学意义。
4.结果及结论
与空白组相比,模型组小鼠30min内扭体反应次数明显增加(P<0.01);
与模型组相比,实施例1、2、5、6、7、8组小鼠扭体反应次数明显降低,且实施例1、2组较实施例5、6、7、8组扭体反应次数较低,其中实施例1组扭体反应次数最少;对比实施例1、2、3、4组小鼠扭体反应次数较实施例组增加,其中,对比实施例1组小鼠扭体反应次数较其他对比实施例组偏低。
表1各组小鼠扭体反应次数比较(n=10)
组别 | 扭体次数 |
空白组 | 2.36±0.64 |
模型组 | 38.67±9.57* |
实施例1组 | 9.67±11.59@# |
实施例2组 | 10.34±2.01@# |
实施例5组 | 12.36±2.09*# |
实施例6组 | 11.97±2.41@# |
实施例7组 | 12.09±1.59*# |
实施例8组 | 12.37±2.51*# |
对比实施例1 | 21.36±3.58*# |
对比实施例2 | 29.87±4.65*△ |
对比实施例3 | 30.84±5.08*△ |
对比实施例4 | 33.94±5.34*△ |
注:与空白组对比,@P<0.05,*P<0.01;
与模型组对比,△P<0.05,#P<0.01。
二、临床使用资料
1.一般资料:
2018年-2020年收集我院确诊为癌症疼痛的患者28例,随机分为本发明中药贴剂组、芬太尼透皮贴组。本发明中药贴剂组14例,男8例,女6例,年龄最大者60岁,最小者40岁;芬太尼透皮贴组14例,男7例,女7例,年龄最大者60岁,年龄最小者41岁。
2.癌症疼痛的分级标准:
参照中华人民共和国卫生部2011年版《癌症疼痛诊疗规范》主诉疼痛程度分级法的建议制定:根据患者对疼痛的主诉,将疼痛分为轻度、中度、重度三类。
(1)轻度疼痛:有疼痛但可以忍受,生活正常,睡眠无干扰。
(2)中度疼痛:疼痛明显,不能忍受,要求服用镇痛药物,睡眠受干扰。
(3)重度疼痛:疼痛剧烈,不能忍受,需要镇痛药物,睡眠受严重干扰,可伴自主神经紊乱或被动体位。
3.纳入标准
肿瘤患者;预期生存时间6个月以上;无智力及精神障碍,语言表达正常,可对自身疼痛做出判断;自愿参加试验研究。
4.排除标准
妊娠和哺乳患者;局部有破损,不可将膏药直接贴在破损处者;精神病患者;其他不符合纳入标准,影响疗效或安全性判断者。
5.治疗方案
本发明中药贴剂组采用本发明实施例1所得粉剂,30g/贴,1贴/1次,局部贴敷,1天更换一次,15天统计疗效。
对照组为芬太尼透皮贴组,2.1mg/贴,1贴/1次,疗程同本发明中药贴剂组。
6.疗效评定标准:
采用WHO疼痛疗效标准结合数字评分(NRS)法双重判定:
(1)完全缓解:完全无疼痛,NRS评分0分;
(2)中度缓解:疼痛较前明显减轻,睡眠不受影响,NRS评分减少1/2-3/4;
(3)轻度缓解:疼痛较前减轻,但仍明显疼痛,NRS评分减少小于1/2;
(4)无效:疼痛较前无减轻,NRS评分无减少。
总有效率=完全缓解+中度缓解+轻度缓解
7.结果:
表1两组患者用药后重度疼痛缓解情况比较(例,%)
组别 | 例数 | 完全缓解 | 中度缓解 | 轻度缓解 | 无效 | 总有效率 |
本发明中药贴剂组 | 14 | 1(7.14) | 4(28.57) | 4(28.57) | 5(35.71) | 64.26 |
芬太尼组 | 14 | 1(7.14) | 4(28.57) | 6(42.86) | 3(21.43) | 78.57 |
表2两组患者用药后中度疼痛缓解情况比较(%)
组别 | 例数 | 完全缓解 | 中度缓解 | 轻度缓解 | 无效 | 总有效率 |
本发明中药贴剂组 | 14 | 3(21.43) | 5(35.71) | 4(28.57) | 2(14.29) | 85.71 |
芬太尼组 | 14 | 2(14.29) | 8(57.14) | 3(21.43) | 1(7.14) | 92.86 |
由上表1、2可知,本发明中药贴剂对中、重度疼痛的缓解总有效率分别为85.71%、64.26%。其中,本发明中药贴剂组不良反应的发生率为0%。芬太尼透皮贴组出现恶心呕吐者3例(21.43%),皮肤瘙痒者4例(28.57%),头晕者4例(28.57%),嗜睡者2例(14.29%)。
8.结论
综上所述,经临床试验表明,本发明中药贴剂组方科学合理,原料丰富,易生产制备,使用方便,具有活血化瘀、通络止痛、散结消癥之功效,有效用于治疗癌性疼痛,疗效确切可靠,治疗效果与芬太尼透皮贴组相当,且不良反应较芬太尼透皮贴组发生率低,具有很强的临床实际应用价值,有巨大的经济和社会效益。
Claims (6)
1.一种用于减轻或治疗疼痛的中药组合物,其特征在于,所述中药组合物的原料药由以下组成:
延胡索18-25重量份 乌药75-95重量份 土鳖虫33-50重量份
姜黄50-80重量份 补骨脂60-80重量份 芥子50-70重量份
乳香35-50重量份 没药30-50重量份 洋金花3-6重量份
冰片2-3重量份。
2.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物的原料药由以下组成:
延胡索20-23重量份 乌药78-83重量份 土鳖虫35-43重量份
姜黄60-75重量份 补骨脂68-75重量份 芥子55-65重量份
乳香40-48重量份 没药35-43重量份 洋金花3-6重量份
冰片2-3重量份。
3.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物的原料药由以下组成:
延胡索23重量份 乌药80重量份 土鳖虫39重量份
姜黄68重量份 补骨脂73重量份 芥子63重量份
乳香45重量份 没药40重量份 洋金花5重量份
冰片2.8重量份。
4.如权利要求1所述的中药组合物,其特征在于,所述的疼痛为癌性疼痛。
5.如权利要求1-3任一项所述的中药组合物,其特征在于,所述的中药组合物制备成临床上可接受的剂型。
6.如权利要求5所述的中药组合物,其特征在于,所述临床上可接受的剂型为粉剂、膏剂。
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202311289229.7A CN117085102A (zh) | 2022-07-27 | 2022-07-27 | 一种用于减轻或治疗疼痛的中药组合物及其制备方法 |
CN202210892316.0A CN115192684B (zh) | 2022-07-27 | 2022-07-27 | 一种用于减轻或治疗疼痛的中药组合物及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202210892316.0A CN115192684B (zh) | 2022-07-27 | 2022-07-27 | 一种用于减轻或治疗疼痛的中药组合物及其制备方法 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202311289229.7A Division CN117085102A (zh) | 2022-07-27 | 2022-07-27 | 一种用于减轻或治疗疼痛的中药组合物及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN115192684A CN115192684A (zh) | 2022-10-18 |
CN115192684B true CN115192684B (zh) | 2023-10-27 |
Family
ID=83583986
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202311289229.7A Pending CN117085102A (zh) | 2022-07-27 | 2022-07-27 | 一种用于减轻或治疗疼痛的中药组合物及其制备方法 |
CN202210892316.0A Active CN115192684B (zh) | 2022-07-27 | 2022-07-27 | 一种用于减轻或治疗疼痛的中药组合物及其制备方法 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202311289229.7A Pending CN117085102A (zh) | 2022-07-27 | 2022-07-27 | 一种用于减轻或治疗疼痛的中药组合物及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (2) | CN117085102A (zh) |
-
2022
- 2022-07-27 CN CN202311289229.7A patent/CN117085102A/zh active Pending
- 2022-07-27 CN CN202210892316.0A patent/CN115192684B/zh active Active
Non-Patent Citations (2)
Title |
---|
中药外用制剂治疗癌性疼痛临床研究现状;谭桥秀等;中国实用医药;第10卷(第29期);276-278 * |
中药贴敷治疗癌性疼痛研究进展;夏克春等;山东中医药大学学报;第36卷(第2期);170-173 * |
Also Published As
Publication number | Publication date |
---|---|
CN117085102A (zh) | 2023-11-21 |
CN115192684A (zh) | 2022-10-18 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN108354981A (zh) | 一种小金橡胶贴膏及其制备方法与用途 | |
CN102274252B (zh) | 治疗类风湿病的野木瓜外用制剂及其制备方法 | |
CN101926969B (zh) | 一种治疗神经根型颈椎病的中药组合物及其制备方法 | |
CN105497261A (zh) | 一种外用贴剂基质及该基质制成的外用贴剂和助眠贴 | |
CN104524247B (zh) | 一种治疗偏头痛的药物组合物及其用途 | |
CN115192684B (zh) | 一种用于减轻或治疗疼痛的中药组合物及其制备方法 | |
CN1054526C (zh) | 治疗癫痫的中成药 | |
CN108578603B (zh) | 基于“少阳主骨”理论的治疗肾虚髓亏型膝骨关节炎的中药复方及其应用 | |
CN104587209B (zh) | 一种治疗坐骨神经痛的药剂 | |
CN105233167A (zh) | 一种治疗血管神经性头痛的药物组合物 | |
CN100455309C (zh) | 一种治疗妇科炎症的复方中药制剂及其制备方法 | |
CN104435437B (zh) | 一种治疗三叉神经痛并发舌咽神经痛的中药及其制备方法 | |
CN1686194A (zh) | 一种治疗偏头痛的药及其制备方法 | |
CN111494446B (zh) | 治疗胆绞痛的中药组合物及其应用 | |
CN115624582B (zh) | 新定膝痛方及其制备方法和用途 | |
US11684631B2 (en) | Method of treating cancer with composition of traditional Chinese medicine and its preparation method thereof | |
CN111920891B (zh) | 一种温中止痛的药物组合物及其制备方法和用途 | |
CN108686178B (zh) | 一种治疗帕金森病的中药穴位贴膏剂及其制备方法 | |
CN101095759B (zh) | 一种抹肚脐治疗便秘的药物 | |
CN107362296B (zh) | 治疗皮肤良性肿瘤的药物及其制备方法 | |
CN105770265A (zh) | 一种用于食道癌的药物制剂及其用途 | |
CN105194352A (zh) | 一种改善学习记忆的中药组合物及其制备方法 | |
CN105434544A (zh) | 一种治疗腰椎间盘突出症的中药组合物 | |
WO2023004940A1 (zh) | 一种药物组合物及艾瑞昔布在制备抗神经根颈椎病药剂中的应用 | |
CN115154528A (zh) | 一种治疗前列腺炎、前列腺增生的中药外用贴剂 |
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 |