CN117462629A - Traditional Chinese medicine composition for preventing and treating adverse reactions related to tumor immunotherapy as well as preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for preventing and treating adverse reactions related to tumor immunotherapy as well as preparation method and application thereof Download PDFInfo
- Publication number
- CN117462629A CN117462629A CN202311654113.9A CN202311654113A CN117462629A CN 117462629 A CN117462629 A CN 117462629A CN 202311654113 A CN202311654113 A CN 202311654113A CN 117462629 A CN117462629 A CN 117462629A
- Authority
- CN
- China
- Prior art keywords
- parts
- traditional chinese
- chinese medicine
- medicine composition
- radix
- 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.)
- Withdrawn
Links
- 239000003814 drug Substances 0.000 title claims abstract description 63
- 239000000203 mixture Substances 0.000 title claims abstract description 48
- 238000009169 immunotherapy Methods 0.000 title claims abstract description 29
- 206010067484 Adverse reaction Diseases 0.000 title claims abstract description 26
- 230000006838 adverse reaction Effects 0.000 title claims abstract description 26
- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- 206010028980 Neoplasm Diseases 0.000 title abstract description 16
- 241001523681 Dendrobium Species 0.000 claims abstract description 18
- 241000405414 Rehmannia Species 0.000 claims abstract description 15
- 241000049624 Alisma plantago-aquatica subsp. orientale Species 0.000 claims abstract description 14
- 235000009051 Ambrosia paniculata var. peruviana Nutrition 0.000 claims abstract description 14
- 235000003097 Artemisia absinthium Nutrition 0.000 claims abstract description 14
- 240000001851 Artemisia dracunculus Species 0.000 claims abstract description 14
- 235000017731 Artemisia dracunculus ssp. dracunculus Nutrition 0.000 claims abstract description 14
- 235000003261 Artemisia vulgaris Nutrition 0.000 claims abstract description 14
- 235000009008 Eriobotrya japonica Nutrition 0.000 claims abstract description 14
- 240000005373 Panax quinquefolius Species 0.000 claims abstract description 14
- 235000003140 Panax quinquefolius Nutrition 0.000 claims abstract description 14
- 239000001138 artemisia absinthium Substances 0.000 claims abstract description 14
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims abstract description 14
- 240000002948 Ophiopogon intermedius Species 0.000 claims abstract description 13
- 206010012735 Diarrhoea Diseases 0.000 claims abstract description 11
- 208000010201 Exanthema Diseases 0.000 claims abstract description 11
- 206010047700 Vomiting Diseases 0.000 claims abstract description 11
- 201000005884 exanthem Diseases 0.000 claims abstract description 11
- 206010037844 rash Diseases 0.000 claims abstract description 11
- 244000303040 Glycyrrhiza glabra Species 0.000 claims abstract description 7
- 235000006200 Glycyrrhiza glabra Nutrition 0.000 claims abstract description 7
- 241000045403 Astragalus propinquus Species 0.000 claims abstract description 6
- 235000006533 astragalus Nutrition 0.000 claims abstract description 6
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 claims abstract description 6
- 235000011477 liquorice Nutrition 0.000 claims abstract description 6
- 241000050051 Chelone glabra Species 0.000 claims abstract 5
- 244000061508 Eriobotrya japonica Species 0.000 claims abstract 5
- 238000000605 extraction Methods 0.000 claims description 22
- 239000009636 Huang Qi Substances 0.000 claims description 12
- 239000002904 solvent Substances 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 244000183685 Citrus aurantium Species 0.000 claims description 8
- 235000007716 Citrus aurantium Nutrition 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 8
- 238000002156 mixing Methods 0.000 claims description 6
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 6
- 244000003416 Asparagus officinalis Species 0.000 claims description 5
- 235000005340 Asparagus officinalis Nutrition 0.000 claims description 5
- -1 glidants Substances 0.000 claims description 5
- 239000002994 raw material Substances 0.000 claims description 5
- 238000005303 weighing Methods 0.000 claims description 5
- 239000011248 coating agent Substances 0.000 claims description 4
- 239000003937 drug carrier Substances 0.000 claims description 4
- 230000010354 integration Effects 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 4
- 206010059024 Gastrointestinal toxicity Diseases 0.000 claims description 3
- 206010019670 Hepatic function abnormal Diseases 0.000 claims description 3
- 206010061924 Pulmonary toxicity Diseases 0.000 claims description 3
- 206010059516 Skin toxicity Diseases 0.000 claims description 3
- 230000005856 abnormality Effects 0.000 claims description 3
- 230000002124 endocrine Effects 0.000 claims description 3
- 231100000414 gastrointestinal toxicity Toxicity 0.000 claims description 3
- 239000008187 granular material Substances 0.000 claims description 3
- 231100000374 pneumotoxicity Toxicity 0.000 claims description 3
- 230000007047 pulmonary toxicity Effects 0.000 claims description 3
- 231100000438 skin toxicity Toxicity 0.000 claims description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 2
- 239000002250 absorbent Substances 0.000 claims description 2
- 230000002745 absorbent Effects 0.000 claims description 2
- 239000000443 aerosol Substances 0.000 claims description 2
- 230000000181 anti-adherent effect Effects 0.000 claims description 2
- 239000003911 antiadherent Substances 0.000 claims description 2
- 229940107666 astragalus root Drugs 0.000 claims description 2
- 239000011230 binding agent Substances 0.000 claims description 2
- 239000000872 buffer Substances 0.000 claims description 2
- 239000002775 capsule Substances 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- 238000000576 coating method Methods 0.000 claims description 2
- 239000003086 colorant Substances 0.000 claims description 2
- 239000006071 cream Substances 0.000 claims description 2
- 239000003085 diluting agent Substances 0.000 claims description 2
- 239000007884 disintegrant Substances 0.000 claims description 2
- 239000003995 emulsifying agent Substances 0.000 claims description 2
- 239000000945 filler Substances 0.000 claims description 2
- 239000000796 flavoring agent Substances 0.000 claims description 2
- 235000013355 food flavoring agent Nutrition 0.000 claims description 2
- 239000003205 fragrance Substances 0.000 claims description 2
- 239000003906 humectant Substances 0.000 claims description 2
- 238000002347 injection Methods 0.000 claims description 2
- 239000007924 injection Substances 0.000 claims description 2
- 229940040145 liniment Drugs 0.000 claims description 2
- 239000000865 liniment Substances 0.000 claims description 2
- 239000006210 lotion Substances 0.000 claims description 2
- 239000000314 lubricant Substances 0.000 claims description 2
- 239000011159 matrix material Substances 0.000 claims description 2
- 239000002674 ointment Substances 0.000 claims description 2
- 230000003204 osmotic effect Effects 0.000 claims description 2
- 238000005325 percolation Methods 0.000 claims description 2
- 239000006187 pill Substances 0.000 claims description 2
- 239000004014 plasticizer Substances 0.000 claims description 2
- 239000000843 powder Substances 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- 238000010992 reflux Methods 0.000 claims description 2
- 239000000243 solution Substances 0.000 claims description 2
- 239000007921 spray Substances 0.000 claims description 2
- 239000003381 stabilizer Substances 0.000 claims description 2
- 238000001256 steam distillation Methods 0.000 claims description 2
- 239000000829 suppository Substances 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 239000000375 suspending agent Substances 0.000 claims description 2
- 239000002562 thickening agent Substances 0.000 claims description 2
- 229940098465 tincture Drugs 0.000 claims description 2
- 238000002137 ultrasound extraction Methods 0.000 claims description 2
- 239000000080 wetting agent Substances 0.000 claims description 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 239000000499 gel Substances 0.000 claims 1
- 238000007654 immersion Methods 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 22
- 230000003908 liver function Effects 0.000 abstract description 8
- 230000006378 damage Effects 0.000 abstract description 6
- 229940126680 traditional chinese medicines Drugs 0.000 abstract description 5
- 230000000295 complement effect Effects 0.000 abstract description 2
- 230000000144 pharmacologic effect Effects 0.000 abstract description 2
- 230000002195 synergetic effect Effects 0.000 abstract description 2
- 208000024891 symptom Diseases 0.000 description 13
- 229940079593 drug Drugs 0.000 description 11
- 241001092070 Eriobotrya Species 0.000 description 9
- 241000207929 Scutellaria Species 0.000 description 9
- 206010058467 Lung neoplasm malignant Diseases 0.000 description 6
- 201000005202 lung cancer Diseases 0.000 description 6
- 208000020816 lung neoplasm Diseases 0.000 description 6
- 230000036541 health Effects 0.000 description 5
- 238000010438 heat treatment Methods 0.000 description 5
- 201000011510 cancer Diseases 0.000 description 4
- 230000009467 reduction Effects 0.000 description 4
- 230000002411 adverse Effects 0.000 description 3
- 238000002619 cancer immunotherapy Methods 0.000 description 3
- 238000001914 filtration Methods 0.000 description 3
- 230000036737 immune function Effects 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 230000001737 promoting effect Effects 0.000 description 3
- 210000002784 stomach Anatomy 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- 102000004127 Cytokines Human genes 0.000 description 2
- 108090000695 Cytokines Proteins 0.000 description 2
- 241000721047 Danaus plexippus Species 0.000 description 2
- 229940076838 Immune checkpoint inhibitor Drugs 0.000 description 2
- 102000037984 Inhibitory immune checkpoint proteins Human genes 0.000 description 2
- 108091008026 Inhibitory immune checkpoint proteins Proteins 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 239000010839 body fluid Substances 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 230000006735 deficit Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000012274 immune-checkpoint protein inhibitor Substances 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- 210000004072 lung Anatomy 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000002203 pretreatment Methods 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 230000008685 targeting Effects 0.000 description 2
- VHRSUDSXCMQTMA-PJHHCJLFSA-N 6alpha-methylprednisolone Chemical compound C([C@@]12C)=CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2[C@@H](O)C[C@]2(C)[C@@](O)(C(=O)CO)CC[C@H]21 VHRSUDSXCMQTMA-PJHHCJLFSA-N 0.000 description 1
- 235000002991 Coptis groenlandica Nutrition 0.000 description 1
- 244000247747 Coptis groenlandica Species 0.000 description 1
- 241001071795 Gentiana Species 0.000 description 1
- 235000017443 Hedysarum boreale Nutrition 0.000 description 1
- 235000007858 Hedysarum occidentale Nutrition 0.000 description 1
- 235000002226 Ranunculus ficaria Nutrition 0.000 description 1
- 244000081426 Ranunculus ficaria Species 0.000 description 1
- 240000004534 Scutellaria baicalensis Species 0.000 description 1
- 235000017089 Scutellaria baicalensis Nutrition 0.000 description 1
- 210000001744 T-lymphocyte Anatomy 0.000 description 1
- 208000031971 Yin Deficiency Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 229940022399 cancer vaccine Drugs 0.000 description 1
- 238000009566 cancer vaccine Methods 0.000 description 1
- 230000003915 cell function Effects 0.000 description 1
- 238000002659 cell therapy Methods 0.000 description 1
- 230000002380 cytological effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000000684 flow cytometry Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000001947 glycyrrhiza glabra rhizome/root Substances 0.000 description 1
- 230000003862 health status Effects 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 210000002865 immune cell Anatomy 0.000 description 1
- 230000028993 immune response Effects 0.000 description 1
- 230000001024 immunotherapeutic effect Effects 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 229960004584 methylprednisolone Drugs 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 238000002791 soaking Methods 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 229960005486 vaccine Drugs 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)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
-
- 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)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
-
- 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
- A61K36/282—Artemisia, e.g. wormwood or sagebrush
-
- 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
- A61K36/481—Astragalus (milkvetch)
-
- 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
- A61K36/484—Glycyrrhiza (licorice)
-
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
-
- 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
-
- 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)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
-
- 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)
- A61K36/884—Alismataceae (Water-plantain family)
-
- 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)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8965—Asparagus, e.g. garden asparagus or asparagus fern
-
- 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)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8968—Ophiopogon (Lilyturf)
-
- 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)
- A61K36/898—Orchidaceae (Orchid family)
- A61K36/8984—Dendrobium
-
- 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
- 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
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
-
- 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
- A61P1/12—Antidiarrhoeals
-
- 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
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Medical Informatics (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Pulmonology (AREA)
- Neurosurgery (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Hospice & Palliative Care (AREA)
- Otolaryngology (AREA)
- Gastroenterology & Hepatology (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to the field of traditional Chinese medicines, and in particular provides a traditional Chinese medicine composition for preventing and treating adverse reactions related to tumor immunotherapy, and a preparation method and application thereof, wherein the traditional Chinese medicine composition comprises, by weight, 15-20 parts of radix rehmanniae, 15-20 parts of prepared rehmannia root, 10-15 parts of dwarf lilyturf tuber, 10-12 parts of radix asparagi, 8-10 parts of dendrobium, 4-8 parts of fructus aurantii, 15-20 parts of virgate wormwood herb, 8-12 parts of baical skullcap root, 10-14 parts of loquat leaf, 6-8 parts of liquorice, 6-8 parts of American ginseng, 6-8 parts of oriental waterplantain rhizome and 6-8 parts of astragalus mongholicus. The components in the formula complement each other and the synergistic effect is an important basis of the pharmacological effect, and has remarkable treatment effect on related adverse reactions such as rash, diarrhea, nausea and vomiting, liver function damage and the like caused by tumor immunotherapy.
Description
Technical Field
The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for preventing and treating adverse reactions related to tumor immunotherapy, and a preparation method and application thereof.
Background
In recent years, immunotherapy has become the focus of the field of tumor therapy. To date, immunotherapy has developed in a variety of forms including immune checkpoint inhibitors, targeting antibodies, cancer vaccines, cytokines, and immune adjuvants, among others. At home and abroad, these immunotherapies have been batched to treat a number of malignant tumors, which have been increasingly used in clinic. However, while immunotherapy is carried with the life of cancer patients, this immune response, which enhances T cell function, also leads to a series of systemic and organ-specific immune related adverse reactions, so-called side effects. For the most common types of immunotherapy, about 5% to 10% of patients may experience side effects, and about 1% to 2% of patients may be life threatening. Common adverse reactions include pulmonary toxicity, gastrointestinal toxicity, skin toxicity, endocrine abnormalities, and the like. The quality of life of partial tumor patients is reduced, even the treatment course is interrupted, the treatment effect is influenced, the traditional Chinese medicine plays an important role in treating diseases, the advantages of the traditional Chinese medicine are fully exerted, and the development of the traditional Chinese medicine composition for effectively treating side effects brought by immunotherapy is an urgent problem to be solved.
Disclosure of Invention
Therefore, the invention aims to provide a traditional Chinese medicine composition for preventing and treating adverse reactions related to tumor immunotherapy, and a preparation method and application thereof, so as to prevent, treat or reduce the related adverse reactions caused by the tumor immunotherapy.
The invention provides a traditional Chinese medicine composition, which comprises, by weight, 15-20 parts of radix rehmanniae, 15-20 parts of prepared rehmannia root, 10-15 parts of dwarf lilyturf tuber, 10-12 parts of radix asparagi, 8-10 parts of dendrobium, 4-8 parts of fructus aurantii, 15-20 parts of virgate wormwood herb, 8-12 parts of baical skullcap root, 10-14 parts of loquat leaf, 6-8 parts of liquorice, 6-8 parts of American ginseng, 6-8 parts of oriental waterplantain rhizome and 6-8 parts of astragalus mongholicus.
Further, the dendrobium is dried dendrobium; and/or, the fructus Aurantii is prepared fructus Aurantii.
Further, the traditional Chinese medicine composition comprises, by weight, 15 parts of radix rehmanniae, 15 parts of prepared rehmannia root, 10 parts of dwarf lilyturf tuber, 12 parts of asparagus, 10 parts of dendrobium, 6 parts of bitter orange, 15 parts of virgate wormwood herb, 9 parts of baical skullcap root, 12 parts of loquat leaf, 6 parts of liquoric root, 6 parts of oriental waterplantain rhizome, 6 parts of American ginseng and 8 parts of membranous milkvetch root; or,
the traditional Chinese medicine composition comprises 15 parts of radix rehmanniae, 15 parts of prepared rehmannia root, 10 parts of dwarf lilyturf tuber, 12 parts of radix asparagi, 10 parts of dendrobium, 6 parts of bitter orange, 15 parts of virgate wormwood herb, 12 parts of baical skullcap root, 14 parts of loquat leaf, 8 parts of liquoric root, 8 parts of oriental waterplantain rhizome, 8 parts of American ginseng and 6 parts of membranous milkvetch root; or,
the traditional Chinese medicine composition comprises 20 parts of radix rehmanniae, 20 parts of prepared rehmannia root, 15 parts of dwarf lilyturf tuber, 10 parts of radix asparagi, 8 parts of dendrobium, 8 parts of fructus aurantii, 20 parts of virgate wormwood herb, 9 parts of baical skullcap root, 12 parts of loquat leaf, 6 parts of liquorice, 6 parts of oriental waterplantain rhizome, 6 parts of American ginseng and 6 parts of astragalus membranaceus.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: weighing radix rehmanniae, radix rehmanniae Preparata, radix Ophiopogonis, radix asparagi, herba Dendrobii, fructus Aurantii, herba Artemisiae Scopariae, scutellariae radix, folium Eriobotryae, glycyrrhrizae radix, alismatis rhizoma, radix Panacis Quinquefolii and radix astragali according to the selected weight parts, mixing, extracting by conventional extraction method or respectively extracting by conventional extraction method, and mixing.
Further, the conventional extraction method comprises one or more of water decoction, soaking extraction, percolation extraction, reflux extraction, ultrasonic extraction and steam distillation extraction.
Further, the extraction solvent is selected from water or alcohol solution with the volume percentage of 5-98%; the extraction times are at least 1 time; the extraction time is at least 10min; the ratio of the volume of the extraction solvent to the weight of the raw materials is more than or equal to 2L/kg.
The invention also provides a pharmaceutical preparation which comprises the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation method, and optionally one or more pharmaceutically acceptable carriers;
preferably, the pharmaceutically acceptable carrier is selected from at least one of pharmaceutically acceptable solvents, solubilizers, co-solvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adherents, integration agents, permeation promoters, pH regulators, buffers, plasticizers, surfactants, thickeners, coating agents, humectants, absorbents, diluents, flocculant and deflocculant, filter aids, release retarders, polymeric matrix materials, and film forming materials.
Further, the pharmaceutical preparation is a gel, a cream, a tablet, a capsule, a powder, a mixture, a pill, a granule, an oral liquid, a syrup, a decoction, a suppository, an aerosol, a emplastrum, an ointment, an injection, a spray, a liniment, a tincture, a wet compress, a paste or a lotion.
The invention also provides an application of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by any one of the preparation methods or the medicine preparation in medicines for preventing, treating or relieving related adverse reactions caused by tumor immunotherapy.
Further, the related adverse reaction comprises one or more of pulmonary toxicity, gastrointestinal toxicity, skin toxicity and endocrine abnormality; preferably, the adverse reaction comprises one or more of rash, diarrhea, nausea and vomiting, impaired liver function.
Further, the immunotherapy includes at least one of cytokine therapy, immune cell therapy, tumor vaccine therapy, immune checkpoint inhibitors, targeting antibodies, and immune adjuvants.
The technical scheme of the invention has the following advantages:
1. the invention provides a traditional Chinese medicine composition, which comprises, by weight, 15-20 parts of radix rehmanniae, 15-20 parts of prepared rehmannia root, 10-15 parts of dwarf lilyturf tuber, 10-12 parts of radix asparagi, 8-10 parts of dendrobium, 4-8 parts of fructus aurantii, 15-20 parts of virgate wormwood herb, 8-12 parts of baical skullcap root, 10-14 parts of loquat leaf, 6-8 parts of liquorice, 6-8 parts of American ginseng, 6-8 parts of oriental waterplantain rhizome and 6-8 parts of astragalus mongholicus. The components in the formula complement each other and the synergistic effect is an important basis of the pharmacological effect, and the content of various potential active components is closely related to the clinical treatment effect. Under a specific proportion, the traditional Chinese medicine composition has obvious treatment effect on related adverse reactions such as rash, diarrhea, nausea and vomiting, liver function damage and the like caused by tumor immunotherapy.
Wherein, the raw rehmannia root and the virgate wormwood herb in the prescription are monarch drugs for clearing damp-heat and nourishing stomach yin; radix asparagi, radix ophiopogonis and dendrobium are taken as ministerial drugs, and the three drugs have the effects of clearing heat and promoting fluid production; after the monarch drug and the ministerial drug are compatible, the medicine can not only nourish yin of lung, stomach and liver and kidney and regulate yin deficiency of organism to treat the root cause, but also clear damp-heat of lung, stomach and liver and gall to remove excess evil eroded organism to treat the root cause and treat both the symptoms and root cause. The five medicines together play the roles of clearing heat and detoxicating and clearing damp and heat together with the prepared rehmannia root, the baical skullcap root, the loquat leaf, the bitter orange and the oriental waterplantain rhizome; licorice root, radix Glycyrrhizae Praeparata regulates the action of the other drugs, astragalus root, radix astragali has the effects of invigorating qi, consolidating superficial resistance, invigorating spleen qi, and American ginseng, which are all combined as guiding drugs.
The medicines together play roles in nourishing yin, promoting the production of body fluid, clearing damp-heat, and descending qi, and play a positive role in treating related adverse reactions caused by tumor immunotherapy.
2. The thirteen traditional Chinese medicines in the formula supplement each other, and are unavoidably absent, and if other traditional Chinese medicines with the effects of clearing heat, nourishing yin and promoting the production of body fluid such as figwort are adopted to replace the radix rehmanniae of the invention, or traditional Chinese medicines with the effects of clearing heat, drying dampness such as gentian and coptis are adopted to replace the herba artemisiae scopariae or the baikal skullcap root of the invention, the treatment effect on the related adverse reactions caused by tumor immunotherapy can be greatly affected.
3. The traditional Chinese medicine composition has good effects on rash, diarrhea, nausea and vomiting and liver function damage caused by immunotherapy; wherein the immunotherapy is tumor immunotherapy.
Detailed Description
The following examples are provided for a better understanding of the present invention and are not limited to the preferred embodiments described herein, but are not intended to limit the scope of the invention, any product which is the same or similar to the present invention, whether in light of the present teachings or in combination with other prior art features, falls within the scope of the present invention.
The specific experimental procedures or conditions are not noted in the examples and may be followed by the operations or conditions of conventional experimental procedures described in the literature in this field. The reagents or apparatus used were conventional reagent products commercially available without the manufacturer's knowledge.
Example 1
The embodiment provides a traditional Chinese medicine composition, which comprises the following raw materials: 15g of radix rehmanniae, 15g of prepared rehmannia root, 10g of dwarf lilyturf tuber, 12g of asparagus, 10g of dried dendrobium, 6g of prepared bitter orange, 15g of virgate wormwood herb, 9g of baical skullcap root, 12g of loquat leaf, 6g of liquoric root, 6g of oriental waterplantain rhizome, 6g of American ginseng and 6g of membranous milkvetch root.
The embodiment also provides a pharmaceutical preparation comprising the traditional Chinese medicine composition, and the preparation method comprises the following steps: weighing radix rehmanniae, radix rehmanniae Preparata, radix Ophiopogonis, radix asparagi, herba Dendrobii, fructus Aurantii, herba Artemisiae Scopariae, scutellariae radix, folium Eriobotryae, glycyrrhrizae radix, alismatis rhizoma, radix Panacis Quinquefolii and radix astragali according to the weight of the prescription of the Chinese medicinal composition, decocting twice, adding 5 times of water for the first time, heating to boil, decocting for 3h to obtain decoction and residue, adding 3 times of water for the second time, decocting 2h after heating to boil, mixing decoctions, and filtering to obtain decoction. Is taken for 10 days 2 times a day, one dose each time.
Example 2
The embodiment provides a traditional Chinese medicine composition, which comprises the following raw materials: 15g of radix rehmanniae, 15g of prepared rehmannia root, 10g of dwarf lilyturf tuber, 12g of asparagus, 10g of dried dendrobium, 6g of prepared bitter orange, 15g of virgate wormwood herb, 12g of baical skullcap root, 14g of loquat leaf, 8g of liquoric root, 8g of oriental waterplantain rhizome, 8g of American ginseng and 6g of membranous milkvetch root.
The embodiment also provides a pharmaceutical preparation comprising the traditional Chinese medicine composition, and the preparation method comprises the following steps: weighing radix rehmanniae, radix rehmanniae Preparata, radix Ophiopogonis, radix asparagi, herba Dendrobii, fructus Aurantii, herba Artemisiae Scopariae, scutellariae radix, folium Eriobotryae, glycyrrhrizae radix, alismatis rhizoma, radix Panacis Quinquefolii and radix astragali according to the weight of the prescription of the Chinese medicinal composition, decocting once, adding 15 times of water, heating to boil, decocting for 5 hr to obtain decoction, and filtering to obtain decoction. Is taken for 10 days 2 times a day, one dose each time.
Example 3
The embodiment provides a traditional Chinese medicine composition, which comprises the following raw materials: 20g of radix rehmanniae, 20g of prepared rehmannia root, 15g of dwarf lilyturf tuber, 10g of asparagus, 8g of dried dendrobium, 8g of prepared bitter orange, 20g of virgate wormwood herb, 9g of baical skullcap root, 12g of loquat leaf, 6g of liquoric root, 6g of oriental waterplantain rhizome, 6g of American ginseng and 6g of membranous milkvetch root.
The embodiment also provides a pharmaceutical preparation comprising the traditional Chinese medicine composition, and the preparation method comprises the following steps: weighing radix rehmanniae, radix rehmanniae Preparata, radix Ophiopogonis, radix asparagi, herba Dendrobii, fructus Aurantii, herba Artemisiae Scopariae, scutellariae radix, folium Eriobotryae, glycyrrhrizae radix, alismatis rhizoma, radix Panacis Quinquefolii and radix astragali according to the weight of the prescription of the Chinese medicinal composition, decocting twice, adding 10 times of water for the first time, heating to boil, decocting for 3h to obtain decoction and residue, adding 20 times of water for the second time, decocting for 2h after heating to boil, mixing decoctions, filtering, concentrating, drying, pulverizing to obtain granule. Is taken for 10 days 2 times a day, one dose each time.
Experimental example 1
1.1 general data
98 malignant tumor patients (lung cancer) harvested and treated in 2022 month 1-2023 month 1 are selected as the study objects, and a random digital table method is applied to divide the study objects into a control group and a treatment group. 22 men and 27 women in the control group; ages 40-73 years, with average age (56.35 + -10.58); 23 men and 26 women in the treatment group; ages 40-74 years, with average age (56.39 + -10.60); clinical staging: 17 cases in III and 32 cases in IV. The differences between the two sets of clinical data were statistically significant (P > 0.05).
Inclusion criteria: (1) the pathological or cytological and imaging diagnosis is carried out on the malignant tumor patients; (2) patients treated primarily by immunotherapy; (3) the expected lifetime is more than or equal to 3 months; (4) voluntarily sign the patient's informed consent. Exclusion criteria: (1) immune-related diseases, intolerant to immunotherapeutics; (2) those who are not economically affordable for treatment; (3) conscious or mental disturbance; (4) and the clinical trials of other drugs just ended.
1.2 method
The control group was orally administered 1mg/kg methylprednisolone daily for 10 days. The treatment group was treated with the decoction prepared in example 1 of the present invention on the basis of the control group 2 times a day, one dose each time, for 10 days continuously.
1.3 observations index
The clinical curative effect refers to the classification standard of the relevant symptoms in the "Chinese medicine New medicine clinical research guidelines". The integration and division ratio of the traditional Chinese medicine symptoms is the ratio of the difference between the traditional Chinese medicine symptoms before and after treatment and the traditional Chinese medicine symptoms before treatment multiplied by 100%. The recovery is that symptoms disappear or are obviously improved, and the percent reduction is more than or equal to 95%; the obvious effect is that symptoms disappear or are improved obviously, and the percent reduction is less than 95% and more than 70%; the effective symptoms are improved or improved, and the percent reduction is less than or equal to 30 and less than 70 percent; the ineffectiveness is that the symptoms are not improved or improved, even aggravated, and the percent reduction is less than 30 percent. The integration of the traditional Chinese medicine symptoms refers to the classification standard of the related symptoms in the "new traditional Chinese medicine clinical research guidelines". Patients were scored for rash, diarrhea, liver function impairment, nausea and vomiting, score no, 2 for mild, 4 for moderate, and 6 for severe. Adverse conditions include rash, diarrhea, impaired liver function, nausea and vomiting.
Immune function: extracting two groups of fasting venous blood before and after treatment, centrifuging, taking serum, and testing CD3 by using a flow cytometry analyzer + 、CD4 + 、CD8 + And CD4 + /CD8 + Horizontal.
A karman functional status score (KarnofskyPerformanceScale, KPS) score: 2 trained observers are jointly present, and the total score is divided into 100 scores according to scores of clinical symptoms, physical signs, daily activity conditions, life self-care conditions, hospitalization indicators, survival conditions and the like, wherein the score is proportional to the health condition. And the KPS score after treatment-the KPS score before treatment is more than or equal to 10 and is divided into health improvement, the health is judged to be reduced by less than or equal to-10, and the KPS score after treatment is less than or equal to 10 and is judged to be stable.
2. Results
2.1 comparison of clinical efficacy
The total effective rate was significantly higher (P < 0.05) in the treated group compared to the control group, as shown in table 1. As can be seen from the table, the total effective cases in the control group of the present application is 34 cases, which account for 69.39% of the total cases in the control group, while the ineffective cases are 15 cases, which account for 30.61% of the total cases in the control group. The total effective cases of the treatment group are 46 cases, which account for 93.88% of the total cases of the treatment group, and the ineffective cases are 3 cases, which account for 6.21% of the total cases of the treatment group. Therefore, the adverse reaction caused by the immunotherapy treated by adopting the traditional Chinese medicine composition has a remarkable improvement effect compared with the adverse reaction caused by the immunotherapy treated by the traditional treatment method.
Table 1 comparison of clinical efficacy in two groups of patients with adverse reactions related to immunotherapy of lung cancer
2.2 integral comparison of the symptoms of Chinese traditional medicine
The difference in scores of rash, diarrhea, liver function impairment, nausea and vomiting before treatment was not statistically significant (P > 0.05) in the two groups. After treatment, both were significantly reduced, with significantly lower treatment groups (P < 0.05) compared to control groups, as shown in table 2. As can be seen from the results in Table 2, the treatment of rash, diarrhea, nausea and vomiting, and liver function damage caused by immunotherapy with the Chinese medicinal composition of the invention has good effects, and has significant differences (P < 0.05) compared with the conventional treatment methods.
TABLE 2 Chinese medicine syndrome score comparison (mean.+ -. Standard deviation, score) for two groups of patients with adverse reactions associated with lung cancer immunotherapy
2.3 comparison of adverse reaction occurrence status
The incidence of adverse events was significantly reduced (P < 0.05) in the treated group compared to the control group as seen in the individual condition following treatment of the patient, as shown in Table 3. As can be seen from the results in table 3, in the control group, there were 7 cases of patients with diarrhea, accounting for 14.29% of the total cases; 1 patient with liver function damage accounts for 2.04% of the total number of patients; 4 patients with nausea and vomiting account for 8.16% of the total number; there were 3 cases of rash patients, accounting for 6.12% of the total cases. In the treatment group, there were 1 patient with diarrhea, accounting for 2.04% of the total; 0 patients with liver function damage account for 0% of the total number of cases; 1 patient with nausea and vomiting accounts for 2.04% of the total number of patients; there were 1 patient with rash, accounting for 2.04% of the total cases.
TABLE 3 comparison of adverse reaction occurrence in two groups of patients with adverse reaction related to immunotherapy of lung cancer
2.4 immune function comparison
Two groups of pre-treatment CD3 + 、CD4 + 、CD8 + And CD4 + /CD8 + The differences were statistically significant (P > 0.05) compared. After treatment, CD3 + 、CD4 + And CD4 + /CD8 + The level is obviously improved (P is less than 0.05), and CD8 + All significantly reduced (P < 0.05), the effect of the treatment group was more pronounced than the control group, with significant differences (P < 0.05), as shown in table 4.
TABLE 4 immune function comparison (mean.+ -. Standard deviation) of two groups of patients with adverse reactions associated with lung cancer immunotherapy
2.5 KPS score comparison
The difference was not statistically significant (P > 0.05) compared to the pre-treatment KPS scores for the two groups. After treatment, the KPS scores of both groups are obviously reduced, compared with the control group, the effect of the treatment group is more obvious, and the treatment group has obvious difference (P is less than 0.05); the health condition improving effect is better (P is less than 0.05). The results in the table show that the traditional Chinese medicine composition can obviously improve the health condition of an immunotherapy patient and improve the score of the card type functional state.
TABLE 5 comparison of the Carlsberg status score and health status for two groups of patients with adverse effects associated with lung cancer immunotherapy
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.
Claims (10)
1. The traditional Chinese medicine composition is characterized by comprising, by weight, 15-20 parts of radix rehmanniae, 15-20 parts of prepared rehmannia root, 10-15 parts of dwarf lilyturf tuber, 10-12 parts of radix asparagi, 8-10 parts of dendrobium, 4-8 parts of fructus aurantii, 15-20 parts of virgate wormwood herb, 8-12 parts of baical skullcap root, 10-14 parts of loquat leaf, 6-8 parts of liquorice, 6-8 parts of American ginseng, 6-8 parts of oriental waterplantain rhizome and 6-8 parts of astragalus mongholicus.
2. The traditional Chinese medicine composition according to claim 1, wherein said dendrobium is dried dendrobium; and/or, the fructus Aurantii is prepared fructus Aurantii.
3. The traditional Chinese medicine composition according to claim 1 or 2, wherein the traditional Chinese medicine composition comprises, by weight, 15 parts of radix rehmanniae, 15 parts of prepared rehmannia root, 10 parts of dwarf lilyturf tuber, 12 parts of asparagus root, 10 parts of dendrobium, 6 parts of bitter orange, 15 parts of virgate wormwood herb, 9 parts of baical skullcap root, 12 parts of loquat leaf, 6 parts of liquoric root, 6 parts of oriental waterplantain rhizome, 6 parts of American ginseng and 8 parts of astragalus root; or,
the traditional Chinese medicine composition comprises 15 parts of radix rehmanniae, 15 parts of prepared rehmannia root, 10 parts of dwarf lilyturf tuber, 12 parts of radix asparagi, 10 parts of dendrobium, 6 parts of bitter orange, 15 parts of virgate wormwood herb, 12 parts of baical skullcap root, 14 parts of loquat leaf, 8 parts of liquoric root, 8 parts of oriental waterplantain rhizome, 8 parts of American ginseng and 6 parts of membranous milkvetch root; or,
the traditional Chinese medicine composition comprises 20 parts of radix rehmanniae, 20 parts of prepared rehmannia root, 15 parts of dwarf lilyturf tuber, 10 parts of radix asparagi, 8 parts of dendrobium, 8 parts of fructus aurantii, 20 parts of virgate wormwood herb, 9 parts of baical skullcap root, 12 parts of loquat leaf, 6 parts of liquorice, 6 parts of oriental waterplantain rhizome, 6 parts of American ginseng and 6 parts of astragalus membranaceus.
4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, comprising the following steps: weighing radix rehmanniae, radix rehmanniae Preparata, radix Ophiopogonis, radix asparagi, herba Dendrobii, fructus Aurantii, herba Artemisiae Scopariae, scutellariae radix, folium Eriobotryae, glycyrrhrizae radix, alismatis rhizoma, radix Panacis Quinquefolii and radix astragali according to the selected weight parts, mixing, extracting by conventional extraction method or respectively extracting by conventional extraction method, and mixing.
5. The method for preparing a Chinese medicinal composition according to claim 4, wherein the conventional extraction method comprises one or more of water decoction, immersion extraction, percolation extraction, reflux extraction, ultrasonic extraction and steam distillation extraction.
6. The method for preparing a Chinese medicinal composition according to claim 4 or 5, wherein the extraction solvent is selected from water or an alcohol solution with a volume percentage of 5-98%; the extraction times are at least 1 time; the extraction time is at least 10min; the ratio of the volume of the extraction solvent to the weight of the raw materials is more than or equal to 2L/kg.
7. A pharmaceutical formulation comprising a Chinese medicinal composition according to any one of claims 1 to 3 or a Chinese medicinal composition prepared by a method according to any one of claims 4 to 6, and optionally one or more pharmaceutically acceptable carriers;
preferably, the pharmaceutically acceptable carrier is selected from at least one of pharmaceutically acceptable solvents, solubilizers, co-solvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adherents, integration agents, permeation promoters, pH regulators, buffers, plasticizers, surfactants, thickeners, coating agents, humectants, absorbents, diluents, flocculant and deflocculant, filter aids, release retarders, polymeric matrix materials, and film forming materials.
8. The pharmaceutical formulation of claim 7, wherein the pharmaceutical formulation is a gel, cream, tablet, capsule, powder, mixture, pill, granule, decoction, suppository, aerosol, patch, ointment, injection, spray, liniment, tincture, wet compress, paste, or lotion.
9. Use of a traditional Chinese medicine composition according to any one of claims 1-3 or a traditional Chinese medicine composition prepared by a preparation method of a traditional Chinese medicine composition according to any one of claims 4-6 or a pharmaceutical preparation according to claim 7 or 8 in the preparation of a medicament for preventing, treating or alleviating related adverse reactions caused by immunotherapy.
10. The use of a traditional Chinese medicine composition according to claim 9, wherein the related adverse reaction comprises one or more of pulmonary toxicity, gastrointestinal toxicity, skin toxicity, endocrine abnormality; preferably, the adverse reaction comprises one or more of rash, diarrhea, nausea and vomiting, impaired liver function.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311654113.9A CN117462629A (en) | 2023-12-05 | 2023-12-05 | Traditional Chinese medicine composition for preventing and treating adverse reactions related to tumor immunotherapy as well as preparation method and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311654113.9A CN117462629A (en) | 2023-12-05 | 2023-12-05 | Traditional Chinese medicine composition for preventing and treating adverse reactions related to tumor immunotherapy as well as preparation method and application thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117462629A true CN117462629A (en) | 2024-01-30 |
Family
ID=89625745
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311654113.9A Withdrawn CN117462629A (en) | 2023-12-05 | 2023-12-05 | Traditional Chinese medicine composition for preventing and treating adverse reactions related to tumor immunotherapy as well as preparation method and application thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117462629A (en) |
-
2023
- 2023-12-05 CN CN202311654113.9A patent/CN117462629A/en not_active Withdrawn
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN112972547B (en) | Traditional Chinese medicine composition for treating qi and blood deficiency syndrome and preparation method and application thereof | |
| CN100361689C (en) | Granular composition for reducing blood fat and process for producing the same | |
| CN102008650A (en) | Compound traditional Chinese medicine preparation for treating tumors and preparation method thereof | |
| CN101020027B (en) | Medicine composition for preventing and treating AIDS and its preparation process and use | |
| CN111375035B (en) | Preparation and application of enteric-coated preparation for treating cervical spondylosis | |
| CN111714553A (en) | A Chinese medicinal composition for treating new coronary pneumonia and/or influenza, and its preparation method | |
| CN111588757A (en) | Traditional Chinese medicine composition for treating chronic obstructive pulmonary disease in stable phase and preparation method thereof | |
| CN100428944C (en) | Compound traditional Chinese medicine for improving eyesight and its prepn. method | |
| CN114288367B (en) | Traditional Chinese medicine composition for treating cough | |
| WO2017113476A1 (en) | Traditional chinese medicine composition for treating gastritis | |
| CN101843675A (en) | Chinese medicament for treating allergic rhinitis and acute/chronic rhinitis, and preparation process thereof | |
| CN101954034B (en) | Chinese medicinal preparation for treating acquired immune deficiency syndrome and preparation method thereof | |
| CN117462629A (en) | Traditional Chinese medicine composition for preventing and treating adverse reactions related to tumor immunotherapy as well as preparation method and application thereof | |
| CN105147996B (en) | Kidney-tonifying marrow-benefiting hematogenesis prescription and preparation method of paste and granules thereof | |
| CN109876127B (en) | Blood-nourishing angelica sinensis capsule and preparation method thereof | |
| CN114099609A (en) | Pharmaceutical composition for treating cough and preparation method thereof | |
| CN110652590B (en) | Traditional Chinese medicine compound for treating diabetes and preparation method and application thereof | |
| CN107823487B (en) | Traditional Chinese medicine composition for treating non-alcoholic fatty liver disease and preparation method and application thereof | |
| CN105434379A (en) | Five flower tea dropping pill and preparation method thereof | |
| CN106563076B (en) | Medicine for treating stomach disease and its preparing method | |
| CN105267818A (en) | Traditional Chinese medicine composition for treating epigastric pain and preparation method thereof | |
| CN104587300A (en) | Traditional Chinese medicine composition for treating acute leukemia and preparation method of traditional Chinese medicine composition | |
| CN113648357B (en) | Application of traditional Chinese medicine composition in preparation of anti-inflammatory drugs and/or immunoregulation drugs | |
| CN109091645A (en) | A kind of pharmaceutical composition with treatment inhibition of HIV | |
| CN114209791B (en) | Traditional Chinese medicine composition for treating autoimmune hepatitis by taking Yunnan rhizoma paridis as main raw material, and preparation method, preparation and application thereof |
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 | ||
| WW01 | Invention patent application withdrawn after publication |
Application publication date: 20240130 |
|
| WW01 | Invention patent application withdrawn after publication |