CN108553578A - 一种4克装小儿肺热咳喘颗粒的制备方法 - Google Patents
一种4克装小儿肺热咳喘颗粒的制备方法 Download PDFInfo
- Publication number
- CN108553578A CN108553578A CN201810544136.7A CN201810544136A CN108553578A CN 108553578 A CN108553578 A CN 108553578A CN 201810544136 A CN201810544136 A CN 201810544136A CN 108553578 A CN108553578 A CN 108553578A
- Authority
- CN
- China
- Prior art keywords
- cough
- granules
- asthma
- grams
- pathogenic heat
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 206010011224 Cough Diseases 0.000 title claims abstract description 56
- 208000006673 asthma Diseases 0.000 title claims abstract description 50
- 210000004072 lung Anatomy 0.000 title claims abstract description 47
- 239000008187 granular material Substances 0.000 title claims abstract description 37
- 230000001717 pathogenic effect Effects 0.000 title claims abstract description 36
- 238000002360 preparation method Methods 0.000 title claims abstract description 21
- 241001465251 Ephedra sinica Species 0.000 claims abstract description 49
- 239000000463 material Substances 0.000 claims abstract description 41
- 239000003814 drug Substances 0.000 claims abstract description 31
- 239000000706 filtrate Substances 0.000 claims abstract description 29
- 239000000843 powder Substances 0.000 claims abstract description 22
- 229930006000 Sucrose Natural products 0.000 claims abstract description 14
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 14
- 229960004793 sucrose Drugs 0.000 claims abstract description 14
- 238000001694 spray drying Methods 0.000 claims abstract description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 42
- 239000006071 cream Substances 0.000 claims description 36
- 239000002245 particle Substances 0.000 claims description 27
- 238000002156 mixing Methods 0.000 claims description 24
- 238000001035 drying Methods 0.000 claims description 18
- 238000001914 filtration Methods 0.000 claims description 11
- 230000009977 dual effect Effects 0.000 claims description 9
- 238000005507 spraying Methods 0.000 claims description 9
- 230000008719 thickening Effects 0.000 claims description 9
- 239000007921 spray Substances 0.000 claims description 7
- 239000007788 liquid Substances 0.000 claims description 3
- 238000000605 extraction Methods 0.000 claims description 2
- 235000014666 liquid concentrate Nutrition 0.000 claims 1
- 239000012141 concentrate Substances 0.000 abstract description 8
- 240000000691 Houttuynia cordata Species 0.000 abstract description 4
- 239000010231 banlangen Substances 0.000 abstract description 4
- 229910052602 gypsum Inorganic materials 0.000 abstract description 4
- 239000010440 gypsum Substances 0.000 abstract description 4
- 210000000582 semen Anatomy 0.000 abstract description 4
- 235000013717 Houttuynia Nutrition 0.000 abstract description 3
- 230000001088 anti-asthma Effects 0.000 abstract description 3
- 238000003809 water extraction Methods 0.000 abstract description 2
- 241000205585 Aquilegia canadensis Species 0.000 abstract 1
- 235000008216 herbs Nutrition 0.000 abstract 1
- 239000000047 product Substances 0.000 description 26
- 238000000034 method Methods 0.000 description 9
- KWGRBVOPPLSCSI-WPRPVWTQSA-N (-)-ephedrine Chemical compound CN[C@@H](C)[C@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WPRPVWTQSA-N 0.000 description 8
- 229940079593 drug Drugs 0.000 description 8
- 241001570521 Lonicera periclymenum Species 0.000 description 7
- 239000004375 Dextrin Substances 0.000 description 6
- 229920001353 Dextrin Polymers 0.000 description 6
- 235000019425 dextrin Nutrition 0.000 description 6
- 241001164374 Calyx Species 0.000 description 5
- 241001573881 Corolla Species 0.000 description 5
- UDIPTWFVPPPURJ-UHFFFAOYSA-M Cyclamate Chemical compound [Na+].[O-]S(=O)(=O)NC1CCCCC1 UDIPTWFVPPPURJ-UHFFFAOYSA-M 0.000 description 5
- 235000009508 confectionery Nutrition 0.000 description 5
- 239000000625 cyclamic acid and its Na and Ca salt Substances 0.000 description 5
- KWGRBVOPPLSCSI-UHFFFAOYSA-N d-ephedrine Natural products CNC(C)C(O)C1=CC=CC=C1 KWGRBVOPPLSCSI-UHFFFAOYSA-N 0.000 description 5
- 235000013399 edible fruits Nutrition 0.000 description 5
- 229960001462 sodium cyclamate Drugs 0.000 description 5
- 230000001225 therapeutic effect Effects 0.000 description 5
- 239000004480 active ingredient Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 229960002179 ephedrine Drugs 0.000 description 4
- 210000004209 hair Anatomy 0.000 description 4
- 238000007493 shaping process Methods 0.000 description 4
- 230000037303 wrinkles Effects 0.000 description 4
- 241000196324 Embryophyta Species 0.000 description 3
- 241000245240 Lonicera Species 0.000 description 3
- 244000018633 Prunus armeniaca Species 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 239000000284 extract Substances 0.000 description 3
- 238000003306 harvesting Methods 0.000 description 3
- 239000012535 impurity Substances 0.000 description 3
- 239000004615 ingredient Substances 0.000 description 3
- 238000007689 inspection Methods 0.000 description 3
- 230000001788 irregular Effects 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000002304 perfume Substances 0.000 description 3
- 208000011580 syndromic disease Diseases 0.000 description 3
- 241000251468 Actinopterygii Species 0.000 description 2
- 238000012935 Averaging Methods 0.000 description 2
- 241000723281 Ephedra equisetina Species 0.000 description 2
- 206010020112 Hirsutism Diseases 0.000 description 2
- 206010062717 Increased upper airway secretion Diseases 0.000 description 2
- 241001170080 Lonicera hypoglauca Species 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 206010030113 Oedema Diseases 0.000 description 2
- 208000004880 Polyuria Diseases 0.000 description 2
- 235000009827 Prunus armeniaca Nutrition 0.000 description 2
- REFJWTPEDVJJIY-UHFFFAOYSA-N Quercetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 REFJWTPEDVJJIY-UHFFFAOYSA-N 0.000 description 2
- 206010006451 bronchitis Diseases 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 239000008367 deionised water Substances 0.000 description 2
- 229910021641 deionized water Inorganic materials 0.000 description 2
- 230000035619 diuresis Effects 0.000 description 2
- 229930003944 flavone Natural products 0.000 description 2
- 150000002213 flavones Chemical class 0.000 description 2
- 235000011949 flavones Nutrition 0.000 description 2
- 150000004676 glycans Chemical class 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 238000011534 incubation Methods 0.000 description 2
- IYRMWMYZSQPJKC-UHFFFAOYSA-N kaempferol Chemical compound C1=CC(O)=CC=C1C1=C(O)C(=O)C2=C(O)C=C(O)C=C2O1 IYRMWMYZSQPJKC-UHFFFAOYSA-N 0.000 description 2
- MWDZOUNAPSSOEL-UHFFFAOYSA-N kaempferol Natural products OC1=C(C(=O)c2cc(O)cc(O)c2O1)c3ccc(O)cc3 MWDZOUNAPSSOEL-UHFFFAOYSA-N 0.000 description 2
- 201000010260 leiomyoma Diseases 0.000 description 2
- 150000007524 organic acids Chemical class 0.000 description 2
- 210000001672 ovary Anatomy 0.000 description 2
- 238000012856 packing Methods 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 208000026435 phlegm Diseases 0.000 description 2
- 229920001282 polysaccharide Polymers 0.000 description 2
- 239000005017 polysaccharide Substances 0.000 description 2
- 230000035900 sweating Effects 0.000 description 2
- 239000001648 tannin Substances 0.000 description 2
- 235000018553 tannin Nutrition 0.000 description 2
- 229920001864 tannin Polymers 0.000 description 2
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 description 1
- SBZWTSHAFILOTE-SOUVJXGZSA-N (2R,3S,4S)-leucocyanidin Chemical compound C1([C@H]2OC3=CC(O)=CC(O)=C3[C@H](O)[C@@H]2O)=CC=C(O)C(O)=C1 SBZWTSHAFILOTE-SOUVJXGZSA-N 0.000 description 1
- KWTSXDURSIMDCE-QMMMGPOBSA-N (S)-amphetamine Chemical class C[C@H](N)CC1=CC=CC=C1 KWTSXDURSIMDCE-QMMMGPOBSA-N 0.000 description 1
- 241000867477 Amara Species 0.000 description 1
- VHUUQVKOLVNVRT-UHFFFAOYSA-N Ammonium hydroxide Chemical compound [NH4+].[OH-] VHUUQVKOLVNVRT-UHFFFAOYSA-N 0.000 description 1
- 235000003840 Amygdalus nana Nutrition 0.000 description 1
- 241000605447 Anemarrhena Species 0.000 description 1
- 241000605445 Anemarrhena asphodeloides Species 0.000 description 1
- 235000010864 Armeniaca mandshurica Nutrition 0.000 description 1
- 244000147617 Armeniaca mandshurica Species 0.000 description 1
- 235000015577 Armeniaca sibirica Nutrition 0.000 description 1
- 244000141006 Armeniaca sibirica Species 0.000 description 1
- 201000004813 Bronchopneumonia Diseases 0.000 description 1
- 244000025254 Cannabis sativa Species 0.000 description 1
- UBSCDKPKWHYZNX-UHFFFAOYSA-N Demethoxycapillarisin Natural products C1=CC(O)=CC=C1OC1=CC(=O)C2=C(O)C=C(O)C=C2O1 UBSCDKPKWHYZNX-UHFFFAOYSA-N 0.000 description 1
- 206010012335 Dependence Diseases 0.000 description 1
- 206010013911 Dysgeusia Diseases 0.000 description 1
- 241000723237 Ephedra intermedia Species 0.000 description 1
- 241000555712 Forsythia Species 0.000 description 1
- 241000576429 Forsythia suspensa Species 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 241000202807 Glycyrrhiza Species 0.000 description 1
- 244000303040 Glycyrrhiza glabra Species 0.000 description 1
- 241001278898 Glycyrrhiza inflata Species 0.000 description 1
- 240000008917 Glycyrrhiza uralensis Species 0.000 description 1
- 235000000554 Glycyrrhiza uralensis Nutrition 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 241000334154 Isatis tinctoria Species 0.000 description 1
- HMXJLDJMSRBOCV-UHFFFAOYSA-N Leucocyanidin Natural products OC1C(OC2C(O)C(Oc3cc(O)cc(O)c23)c4ccc(O)c(O)c4)c5c(O)cc(O)cc5OC1c6ccc(O)c(O)c6 HMXJLDJMSRBOCV-UHFFFAOYSA-N 0.000 description 1
- 241000254023 Locusta Species 0.000 description 1
- 241000173699 Lonicera dasystyla Species 0.000 description 1
- 244000167230 Lonicera japonica Species 0.000 description 1
- 208000019693 Lung disease Diseases 0.000 description 1
- 206010054949 Metaplasia Diseases 0.000 description 1
- 241000207834 Oleaceae Species 0.000 description 1
- 244000248557 Ophiopogon japonicus Species 0.000 description 1
- 241000921313 Phyllopodium Species 0.000 description 1
- 235000011432 Prunus Nutrition 0.000 description 1
- 241000220299 Prunus Species 0.000 description 1
- 235000002413 Prunus ansu Nutrition 0.000 description 1
- ZVOLCUVKHLEPEV-UHFFFAOYSA-N Quercetagetin Natural products C1=C(O)C(O)=CC=C1C1=C(O)C(=O)C2=C(O)C(O)=C(O)C=C2O1 ZVOLCUVKHLEPEV-UHFFFAOYSA-N 0.000 description 1
- HWTZYBCRDDUBJY-UHFFFAOYSA-N Rhynchosin Natural products C1=C(O)C(O)=CC=C1C1=C(O)C(=O)C2=CC(O)=C(O)C=C2O1 HWTZYBCRDDUBJY-UHFFFAOYSA-N 0.000 description 1
- 241000207929 Scutellaria Species 0.000 description 1
- 240000004534 Scutellaria baicalensis Species 0.000 description 1
- 235000017089 Scutellaria baicalensis Nutrition 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- DHXVGJBLRPWPCS-UHFFFAOYSA-N Tetrahydropyran Chemical compound C1CCOCC1 DHXVGJBLRPWPCS-UHFFFAOYSA-N 0.000 description 1
- 230000001800 adrenalinergic effect Effects 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
- 150000003797 alkaloid derivatives Chemical class 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 239000000908 ammonium hydroxide Substances 0.000 description 1
- 229910052925 anhydrite Inorganic materials 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 235000006708 antioxidants Nutrition 0.000 description 1
- 238000009412 basement excavation Methods 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 235000010980 cellulose Nutrition 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 210000000038 chest Anatomy 0.000 description 1
- 150000004683 dihydrates Chemical class 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- QOLIPNRNLBQTAU-UHFFFAOYSA-N flavan Chemical compound C1CC2=CC=CC=C2OC1C1=CC=CC=C1 QOLIPNRNLBQTAU-UHFFFAOYSA-N 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000000762 glandular Effects 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 235000001727 glucose Nutrition 0.000 description 1
- 229930182478 glucoside Natural products 0.000 description 1
- 229960001660 histamine phosphate Drugs 0.000 description 1
- ZHIBQGJKHVBLJJ-UHFFFAOYSA-N histamine phosphate Chemical compound OP(O)(O)=O.OP(O)(O)=O.NCCC1=CNC=N1 ZHIBQGJKHVBLJJ-UHFFFAOYSA-N 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 230000030214 innervation Effects 0.000 description 1
- 235000008777 kaempferol Nutrition 0.000 description 1
- -1 ketone glucoside Chemical class 0.000 description 1
- 235000021374 legumes Nutrition 0.000 description 1
- SBZWTSHAFILOTE-UHFFFAOYSA-N leucocianidol Natural products OC1C(O)C2=C(O)C=C(O)C=C2OC1C1=CC=C(O)C(O)=C1 SBZWTSHAFILOTE-UHFFFAOYSA-N 0.000 description 1
- 229940086558 leucocyanidin Drugs 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 210000001370 mediastinum Anatomy 0.000 description 1
- 230000015689 metaplastic ossification Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- UXOUKMQIEVGVLY-UHFFFAOYSA-N morin Natural products OC1=CC(O)=CC(C2=C(C(=O)C3=C(O)C=C(O)C=C3O2)O)=C1 UXOUKMQIEVGVLY-UHFFFAOYSA-N 0.000 description 1
- 239000002858 neurotransmitter agent Substances 0.000 description 1
- 229960002748 norepinephrine Drugs 0.000 description 1
- SFLSHLFXELFNJZ-UHFFFAOYSA-N norepinephrine Natural products NCC(O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-UHFFFAOYSA-N 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid group Chemical group C(CCCCCCC\C=C/CCCCCCCC)(=O)O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 1
- 229920001277 pectin Polymers 0.000 description 1
- 239000001814 pectin Substances 0.000 description 1
- 235000010987 pectin Nutrition 0.000 description 1
- 229920002338 polyhydroxyethylmethacrylate Polymers 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 235000014774 prunus Nutrition 0.000 description 1
- KWGRBVOPPLSCSI-WCBMZHEXSA-N pseudoephedrine Chemical compound CN[C@@H](C)[C@@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WCBMZHEXSA-N 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 235000005875 quercetin Nutrition 0.000 description 1
- 229960001285 quercetin Drugs 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 235000020995 raw meat Nutrition 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000005070 ripening Effects 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- XDQITMCFPPPMBC-TUANDBMESA-N scutelloside Natural products OC[C@H]1O[C@@H](O[C@@H]2O[C@@H]3C[C@H]4[C@H](O)[C@@H](O)[C@@](O)(CO3)[C@@H]24)[C@H](O)[C@@H](O)[C@@H]1O XDQITMCFPPPMBC-TUANDBMESA-N 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 238000000528 statistical test Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000003813 thin hair Effects 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 239000000341 volatile oil Substances 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
- A61K36/17—Gnetophyta, e.g. Ephedraceae (Mormon-tea family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- 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)
- A61K36/19—Acanthaceae (Acanthus family)
- A61K36/195—Strobilanthes
-
- 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
- A61K36/315—Isatis, e.g. Dyer's woad
-
- 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)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
-
- 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)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/634—Forsythia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/78—Saururaceae (Lizard's-tail 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
- A61K36/8964—Anemarrhena
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Botany (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Neurosurgery (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种小儿肺热咳喘颗粒的制备方法:称取以下重量份配比的中药材:麻黄300、苦杏仁600、生石膏2400、甘草300、金银花1000、连翘1000、知母1000、黄芩1000、板蓝根1000、麦冬1000和鱼腥草1000。将上述十一味中药材分两次水提取后,合并滤液,滤液浓缩,喷雾干燥后测定麻黄含量,按照测得的麻黄含量加入相应重量份的蔗糖粉,使得到的4克装小儿肺热咳喘颗粒的麻黄含量为1.80~1.90mg/袋,所制备的小儿肺热咳喘颗粒麻黄含量稳定,具有显著的止咳和平喘作用。
Description
技术领域
本发明涉及药物制剂制备领域,具体涉及一种4克装小儿肺热咳喘颗粒的制备方法。
背景技术
现有的小儿肺热咳喘制剂一般是以麻黄、苦杏仁、生石膏、甘草、金银花、连翘、知母、黄芩、板蓝根、麦冬和鱼腥草十一味中药材为原料制成的,具有清热解毒、宣肺止咳、化痰平喘的功效,临床实践证明,其对于感冒、支气管炎、喘息性支气管炎、支气管肺炎属痰热壅肺症者具有非常显著的疗效。
小儿肺热咳喘制剂多为依据***药品标准中药成方制剂第十八册第14页收载的小儿肺热咳喘冲剂质量标准(WS3-B-3361-98)制备的颗粒剂。
传统的小儿肺热咳喘颗粒的制法为:按处方量称取30g麻黄、60g苦杏仁、240g生石膏、30g甘草、100g金银花、100g连翘、100g知母、100g黄芩、100g板蓝根、100g麦冬和100g鱼腥草十一味中药材,加水煎煮2次,每次1小时,合并煎液,滤过,滤液浓缩的清膏,按清膏1重量份、糊精0.27重量份和环拉酸钠0.05重量份的配比混合后制成颗粒,过筛,分装,即得小儿肺热咳喘颗粒。
上述清膏为水提取产物,制成的小儿肺热咳喘颗粒由于产品质量标准中未能保证成品中生药量稳定,致使产品中麻黄鉴别项不稳定,麻黄含量得不到控制,造成制剂质量不稳定,产品合格率偏低。
申请号为201010134951.X的中国发明专利公开了一种小儿肺热咳喘颗粒的制备方法,将一定重量份的十一味中药材分两组经水提取后,合并滤液,过滤,滤液浓缩得清膏,按清膏1重量份、糊精0.27重量份和环拉酸钠0.05重量份的配比混合后制成颗粒,干燥后即得小儿肺热咳喘颗粒。该方法对水提取药材过程中的水用量进行严格控制,并根据不同的药材特性进行分组提取,制备的小儿肺热咳喘颗粒黄芩苷鉴别项稳定且符合标准要求。该发明将清膏、糊精、环拉酸钠按重量比1∶0.27∶0.05的配比混匀后制成颗粒,可能会造成所得产品中有效成分含量不稳定,进而影响产品的治疗效果。
发明内容
本发明的目的在于提供了一种将有效成分控制在一定范围内的4克装小儿肺热咳喘颗粒的制备方法,使得制备得到的4克装小儿肺热咳喘颗粒的药效显著提高。
一种4克装小儿肺热咳喘颗粒的制备方法,称取如下重量份的中药材:
其特征在于,包括如下步骤:
(1)将所述十一味药材混匀后加水煎煮2次,每次煎煮1~4小时,第一次水的用量为药材总重量的8~12倍量,第二次水的用量为药材总重量的6~10倍量,合并2次得到的提取液,过滤后滤液备用;
(2)将得到的滤液浓缩至相对密度为1.06~1.19的清膏,将清膏喷雾干燥成粉后测定麻黄含量,按照测得的麻黄含量加入蔗糖粉,混匀,制得颗粒;
(3)将得到的颗粒干燥后按4g/袋分装,控制麻黄含量为1.80~1.90mg/袋,制得所述的4克装小儿肺热咳喘颗粒。
麻黄具有发汗散寒、宣肺平喘、利水消肿的功能,主要用于风寒感冒,胸闷喘咳,风水浮肿。已知麻黄中含有生物碱、黄酮、黄烷、鞣质、挥发油、有机酸、多糖等多种成分,其中麻黄碱的含量较高,主要为***类生物碱,该类成分一直以来被认为是麻黄具有平喘功能的有效成分,目前已被分离的有麻黄碱、伪麻黄碱、麻黄次碱、麻黄恶烷等;黄酮类成分主要有:芹菜素、山奈酚、槲皮素、无色矢车菊素等。另外,麻黄中还含有多糖、有机酸、鞣质、黄酮甙、糊精、淀粉、果胶、纤维素、葡萄糖等成分。
现代药理研究证实:麻黄碱是麻黄平喘的有效成分,麻黄碱有类似肾上腺素的交感神经兴奋作用,在机体内可直接激动肾上腺素受体,并间接促进去甲肾上腺素神经递质的释放,同时显著兴奋中枢。麻黄已见报道的其他药理作用还有发汗、利尿、镇咳、平喘、抗过敏、升高血压、抗凝血、免疫抑制、抗氧化等作用。
由于麻黄具有较好的止咳、平喘、散热等作用,本发明将浓缩得到的清膏通过特定的干燥工艺喷雾成型为干粉,测定所得干粉中的麻黄含量来匹配蔗糖粉,得到麻黄量被控制在最有效范围的4克装小儿肺热咳喘颗粒。
本发明直接将清膏干燥喷雾成型为干粉后再与蔗糖粉混合,简化了原有工艺,保证了最终产品的生药量和产量,为后续制粒提供了便利,避免了现有技术中添加多种辅料所带来的影响最终产品生药量和产量的问题。
本发明所得产品中麻黄含量稳定,能充分保证产品的治疗效果,避免了现有技术中仅按照固定配比来添加辅料所造成的产品中有效成分含量不稳定的技术问题。
小儿肺热咳喘颗粒中麻黄含量过量会对服用人群造成一定致瘾性,而产品中麻黄含量过少则达不到最好的治疗效果,故本发明选择将所得4克装小儿肺热咳喘颗粒的麻黄含量控制在在1.80~1.90mg/袋。
为了进一步提高产品生药量以及产品的治疗效果,优选按以下步骤制备:
(1)将所述十一味药材混匀后加水煎煮2次,每次煎煮1~3小时,第一次水的用量为药材总重量的9~11倍量,第二次水的用量为药材总重量的7~9倍量,合并2次得到的提取液,过滤后滤液备用;
(2)将得到的滤液浓缩至相对密度为1.10~1.17的清膏,将清膏喷雾干燥成粉后测定麻黄含量,按照测得的麻黄含量加入蔗糖粉,混匀,制得颗粒;
(3)将得到的颗粒干燥后按4g/袋分装,控制麻黄含量为1.85~1.90mg/袋,制得所述的4克装小儿肺热咳喘颗粒。
优选地,所述步骤(2)中的滤液浓缩在双效节能浓缩器中进行,浓缩温度为60~70℃,浓缩真空度为-0.06~-0.08MPa。
在上述条件下浓缩是为了提高提取收率及进度,节约工时,提高所得清膏中有效成分的含量,同时进一步保证了产品的治疗效果。
优选地,所述步骤(2)中喷雾干燥在喷雾干燥机中进行,控制清膏温度为60~75℃,电机转速为5~10HZ,进风温度为140~160℃,出风温度为80~90℃,有效的控制了流量,保证了喷雾的顺利进行以及喷雾成型为干粉,为后续的生产过程奠定了基础。
优选地,所述步骤(3)中干燥时的干燥温度为75~85℃,干燥时间为1~3小时,这是为了保证产品的最终收率、水分含量以及产品中有效成分的含量。
本品规格为每袋装4g;用法与用量为:开水冲服,三周岁以下一次4g,一日3次;三周岁以上一次4g,一日4次;七周岁以上一次8g,一日3次。
本发明所采用的原药材具体描述如下:
麻黄为麻黄科植物草麻黄Ephedra sinica Stapf、中麻黄Ephedra intermediaSchrenk et C.A.Mey.或木贼麻黄Ephedra equisetina Bge.的干燥草质茎。秋季采割绿色的草质茎,晒干。草麻黄呈细长圆柱形,少分枝;直径1~2mm。有的带少量棕色木质茎。表面淡绿色至黄绿色,有细纵脊线,触之微有粗糙感。节明显,节间长2~6cm。节上有膜质鳞叶,长3~4mm;裂片2(稀3),锐三角形,先端灰白色,反曲,基部联合成筒状,红棕色。体轻,质脆,易折断,断面略呈纤维性,周边绿黄色,髓部红棕色,近圆形。气微香,味涩、微苦。中麻黄多分枝,直径1.5~3mm,有粗糙感。节间长2~6cm,膜质鳞叶长2~3mm,裂片3(稀2),先端锐尖,断面髓部呈三角状圆形。木贼麻黄较多分枝,直径1~1.5mm,无粗糙感。节间长1.5~3cm。膜质鳞叶长1~2mm;裂片2(稀3),上部为短三角形,灰白色,先端多不反曲,基部棕红色至棕黑色。
苦杏仁为蔷薇科植物山杏Prunus armeniaca L.var.ansu Maxim.、西伯利亚杏Prunus sibirica L.、东北杏Prunus mandshurica(Maxim.)Koehne或杏Prunus armeniacaL.的干燥成熟种子。夏季采收成熟果实,除去果肉及核壳,取出种子,晒干。本品呈扁心形,长1~1.9cm,宽0.8~1.5cm,厚0.5~0.8cm。表面黄棕色至深棕色,一端尖,另端钝圆,肥厚,左右不对称。尖端一侧有短线形种脐,圆端合点处向上具多数深棕色的脉纹。种皮薄,子叶2,乳白色,富油性。无臭,味苦。
生石膏指天然的二水石膏(含两个水分子),主要化学成分:CaSO4·nH2O。为纤维状集合体,呈长块状,板块状或不规则块状。白色、灰白色或淡黄色,有的半透明。体重,质软,纵断面具绢丝样光泽,气微,味淡。(清热泻火药)辛、甘,微寒;归肺、胃经。
甘草为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草Glycyrrhizainflata Bat.或光果甘草Glycyrrhiza glabra L.的干燥根及根茎。春、秋二季采挖,除去须根,晒干。根呈圆柱形,长25~100cm,直径0.6~3.5cm。外皮松紧不一。表面红棕色或灰棕色,具显著的纵皱纹、沟纹、皮孔及稀疏的细根痕。质坚实,断面略显纤维性,黄白色,粉性,形成层环明显,射线放射状,有的有裂隙。根茎呈圆柱形,表面有芽痕,断面中部有髓。气微,味甜而特殊。
金银花为忍冬科植物忍冬Lonicera japonica Thunb.、红腺忍冬Lonicerahypoglau-ca Miq.、山银花Lonicera confusμ DC.或毛花柱忍冬Lonicera dasystylaRehd.的干燥花蕾或带初开的花。夏初花开放前采收,干燥。外表黄色或黄褐色,被有短柔毛及腺毛,基部有绿色细小的花萼,5裂,裂片三角形,无毛。剖开花蕾则见5枚雄蕊及1枚雌蕊。花冠唇形,雌雄蕊呈须状伸出。忍冬呈棒状,上粗下细,略弯曲,长2~3cm,上部直径约3mm下部直径约1.5mm。表面黄白色或绿白色(贮久色渐深),密被短柔毛。偶见叶状苞片。花萼绿色,先端5裂,裂片有毛,长约2mm。开放者花冠筒状,先端二唇形;雄蕊5个,附于筒壁,黄色;雌蕊1个,子房无毛。气清香,味淡、微苦。红腺忍冬长2.5~4.5cm,直径0.8~2mm。表面黄白至黄棕色,无毛或疏被毛。萼筒无毛,先端5裂,裂片长三角形,被毛。开放者花冠下唇反转。花柱无毛。山银花长1.6~3.5cm,直径0.5~2mm。萼筒和花冠密被灰白色毛,子房有毛。毛花柱忍冬长2.5~4cm,直径1~2.5mm。表面淡黄色微带紫色,无毛。花萼裂片短三角形。开放者花冠上唇常不整齐,花柱下部多密被长柔毛。
连翘为木犀科植物连翘Forsythia suspensa(Thunb.)Vahl的干燥果实。秋季果实初熟尚带绿色时采收,除去杂质,蒸熟,晒干,***滑,具一纵隔;质脆;种子棕色,多已脱落。气微香,味苦。
知母为百合科植物知母Anemarrhena asphodeloides Bge.的干燥根茎。春、秋二季采挖,除去须根及泥沙,晒干,习称“毛知母”;或除去外皮,晒干。本品呈长条状,微弯曲,略扁,偶有分枝,长3~15cm,直径0.8~1.5cm,一端有浅黄色的茎叶残痕。表面黄棕色至棕色,上面有一凹沟,具紧密排列的环状节,节上密生黄棕色的残存叶基,由两侧向根茎上方生长;下面***而略皱缩,并有凹陷或突起的点状根痕。质硬,易折断,断面黄白色。气微,味微甜、略苦,嚼之带粘性。
黄芩为唇形科植物黄芩Scutellaria baicalensis Georgi的干燥根。春、秋二季采挖,除去须根及泥沙,晒后撞去粗皮,晒干。本品呈圆锥形,扭曲,长8~25cm,直径1~3cm。表面棕黄色或深黄色,有稀疏的疣状细根痕,上部较粗糙,有扭曲的纵皱或不规则的网纹,下部有顺纹和细皱。质硬而脆,易折断,断面黄色,中间红棕色;老根中心枯朽状或中空,呈暗棕色或棕黑色。气微,味苦。
板蓝根为十字花科植物菘蓝Isatis indigotica Fort.的干燥根。秋季采挖,除去泥沙,晒干。呈圆柱形,稍扭曲,长10-20cm直径0.5-1em,表面淡灰黄色或淡棕黄色,有纵皱纹横长皮孔样突起及直根痕,根头略膨大,体实,质略软,断面皮部黄白色,木部黄色,气微,味微甜后苦涩。
麦冬为百合科植物麦冬Ophiopogon japonicus(Thunb.)Ker-Gawl.的干燥块根。夏季采挖,洗净,反复暴晒、堆置,至七八成干,除去须根,干燥。本品呈纺锤形,两端略尖,长1.5~3cm,直径0.3~0.6cm。表面黄白色或淡黄白,有细纵纹。质柔韧,断面黄白色,半透明,中柱细小。气微香,味甘、微苦。
鱼腥草为三白草科植物蕺菜Houttuynia cordata Thunb.的干燥地上部分。夏季茎叶茂盛花穗多时采割,除去杂质,晒干。茎扁圆形,皱缩而弯曲,长20-30cm;表面黄棕色,具纵棱,节明显,下部节处有须根残存;质脆,易折断。叶互生。多皱缩。展平后心形,长3-5,宽3-4.5cm;上面暗绿或黄绿色,下面绿褐色或灰棕色;叶柄细长,基部与托叶合成鞘状。穗状花序项生。搓碎有鱼腥气,味微涩。以叶多、色绿、有花穗、鱼腥气。
本发明与现有技术相比,具有以下有益效果:
(1)本发明方法中通过测定喷雾干燥成粉后的清膏中的麻黄含量来加入相应重量份的蔗糖粉,使得到的4克装小儿肺热咳喘颗粒的麻黄含量为1.80~1.90mg/袋,显著提高了产品的止咳、平喘效果。
(2)本发明将浓缩得到的清膏通过特定的干燥工艺喷雾成型为干粉,再直接将干粉与蔗糖粉混合制得4克装小儿肺热咳喘颗粒,简化了工艺流程、保证了最终产品的生药量,为后续制粒提供了便利。
(3)本发明方法操作简单、生产周期短、无需特殊的设备,成本低、收率高,适于工业化生产。
具体实施方式
实施例1
称取如下重量的中药材:
按以下步骤制备:
(1)将以上十一味药材混匀后加水煎煮2次,每次煎煮1小时,第一次水的用量为药材总重量的8倍量,第二次水的用量为药材总重量的6倍量,合并2次的提取液,过滤后滤液备用;
(2)将得到的滤液在双效节能浓缩器中进行浓缩,浓缩温度为60℃,浓缩真空度为-0.06MPa,得到了相对密度为1.10的清膏,将65℃的清膏在电机转速为5HZ,进风温度为140℃,出风温度为80℃的条件下喷雾干燥后测定麻黄含量,再加入2632g蔗糖粉,混匀,制得颗粒;
(3)将得到的颗粒在75℃下干燥1小时后,按4g/袋分装,测得麻黄含量为1.88mg/袋,得到4克装小儿肺热咳喘颗粒。
实施例2
称取如下重量的中药材:
按以下步骤制备:
(1)将以上十一味药材混匀后加水煎煮2次,每次煎煮1小时,第一次水的用量为药材总重量的9倍量,第二次水的用量为药材总重量的7倍量,合并2次的提取液,过滤后滤液备用;
(2)将得到的滤液在双效节能浓缩器中进行浓缩,浓缩温度为60℃,浓缩真空度为-0.07MPa,得到了相对密度为1.11的清膏,将60℃的清膏在电机转速为7HZ,进风温度为150℃,出风温度为85℃的条件下喷雾干燥后测定麻黄含量,再加入2712g蔗糖粉,混匀,制得颗粒;
(3)将得到的颗粒在80℃下干燥1小时后,按4g/袋分装,测得麻黄含量为1.87mg/袋,得到4克装小儿肺热咳喘颗粒。
实施例3
称取如下重量的中药材:
按以下步骤制备:
(1)将以上十一味药材混匀后加水煎煮2次,每次煎煮1小时,第一次水的用量为药材总重量的10倍量,第二次水的用量为药材总重量的8倍量,合并2次的提取液,过滤后滤液备用;
(2)将得到的滤液在双效节能浓缩器中进行浓缩,浓缩温度为70℃,浓缩真空度为-0.08MPa,得到了相对密度为1.12的清膏,将75℃的清膏在电机转速为8HZ,进风温度为150℃,出风温度为85℃的条件下喷雾干燥后测定麻黄含量,再加入2928g蔗糖粉,混匀,制得颗粒;
(3)将得到的颗粒在82℃下干燥1.5小时后,按4g/袋分装,测得麻黄含量为1.83mg/袋,得到4克装小儿肺热咳喘颗粒。
实施例4
称取如下重量的中药材:
按以下步骤制备:
(1)将以上十一味药材混匀后加水煎煮2次,每次煎煮1小时,第一次水的用量为药材总重量的9倍量,第二次水的用量为药材总重量的7倍量,合并2次的提取液,过滤后滤液备用;
(2)将得到的滤液在双效节能浓缩器中进行浓缩,浓缩温度为75℃,浓缩真空度为-0.06MPa,得到了相对密度为1.17的清膏,将70℃的清膏在电机转速为10HZ,进风温度为160℃,出风温度为80℃的条件下喷雾干燥后测定麻黄含量,再加入2657g蔗糖粉,混匀,制得颗粒;
(3)将得到的颗粒在75℃下干燥1.5小时后,按4g/袋分装,测得麻黄含量为1.85mg/袋,得到4克装小儿肺热咳喘颗粒。
实施例5
称取如下重量的中药材:
按以下步骤制备:
(1)将以上十一味药材混匀后加水煎煮2次,每次煎煮1小时,第一次水的用量为药材总重量的9倍量,第二次水的用量为药材总重量的8倍量,合并2次的提取液,过滤后滤液备用;
(2)将得到的滤液在双效节能浓缩器中进行浓缩,浓缩温度为70℃,浓缩真空度为-0.08MPa,得到了相对密度为1.17的清膏,将75℃的清膏在电机转速为9HZ,进风温度为160℃,出风温度为80℃的条件下喷雾干燥后测定麻黄含量,再加入2684g蔗糖粉,混匀,制得颗粒;
(3)将得到的颗粒在78℃下干燥1小时后,按4g/袋分装,测得麻黄含量为1.86mg/袋,得到4克装小儿肺热咳喘颗粒。
对比例1
称取如下重量的中药材:
按以下步骤制备:
(1)将以上十一味药材混匀后加水煎煮2次,每次煎煮1小时,第一次水的用量为药材总重量的9倍量,第二次水的用量为药材总重量的8倍量,合并2次的提取液,过滤后滤液备用;
(2)将得到的滤液在双效节能浓缩器中进行浓缩,浓缩温度为70℃,浓缩真空度为-0.08MPa,得到了相对密度为1.17的清膏,将清膏、糊精、环拉酸钠按重量比1∶0.27∶0.05的配比混匀后制成颗粒,过筛,按4g/袋分装,测得麻黄含量为1.70mg/袋,得到小儿肺热咳喘颗粒。
对比例2
称取如下重量的中药材:
按以下步骤制备:
(1)将以上十一味药材混匀后加水煎煮2次,每次煎煮1小时,第一次水的用量为药材总重量的8倍量,第二次水的用量为药材总重量的6倍量,合并2次的提取液,过滤后滤液备用;
(2)将得到的滤液在双效节能浓缩器中进行浓缩,浓缩温度为60℃,浓缩真空度为-0.06MPa,得到了相对密度为1.10的清膏,将清膏、糊精、环拉酸钠按重量比1∶0.27∶0.05的配比混匀后制成颗粒,过筛,按4g/袋分装,测得麻黄含量为1.60mg/袋,得到小儿肺热咳喘颗粒。
以上所有实施例和对比例中的麻黄含量都是按照***药品标准中药成方制剂第六册第14页收载的小儿肺热咳喘冲剂质量标准(WS3-B-3361-98)及《国家食品药品监督管理总局标准》YBZ00822015中的方法检测得到。
选用合格的ICR种小鼠100只,体重11-13g,随机分为10组,每组10只,雌雄各半。按下表所示剂量给药,每天1次,连续3天,对照组给予同体积去离子水。于末次给药后40分钟,将每只动物分别置于喷雾装置内,浓度为12.5%的氨水用诱咳引喘仪匀速喷入5秒,仪器自动记录小鼠咳嗽潜伏期,并记数3分钟内咳嗽次数。将各组所得平均值与对照组平均值比较,进行统计学检验,检验结果如下表:
(与对照组比较*p<0.05,**p<0.01)
选用经筛选合格的豚鼠100只,体重180-200g,随机分为5组,每组10只,雌雄各半。按下表所示剂量口服给药,每天1次,连续3天,对照组给予同体积去离子水。于末次给药后40分钟,将每只动物分别置于喷雾装置内,浓度为0.2%的磷酸组胺溶液用诱咳引喘仪匀速喷入18秒,记录豚鼠引喘潜伏期。将各组所得平均值与对照组平均值比较,进行统计学检验,检验结果如下表:
(与对照组比较*p<0.05,**p<0.01)
由此可见,采用本发明方法进行4克装小儿肺热咳喘颗粒的生产,并将其分别用于小鼠和豚鼠上,能够显著地延长小鼠咳嗽潜伏期,减少咳嗽次数,同时能够非常显著地延长豚鼠的引喘潜伏期,表明所制得的4克装小儿肺热咳喘颗粒具有明显的止咳和平喘作用。
Claims (7)
1.一种4克装小儿肺热咳喘颗粒的制备方法,称取如下重量份的中药材:
其特征在于,包括如下步骤:
(1)将所述十一味药材混匀后加水煎煮2次,每次煎煮1~4小时,第一次水的用量为药材总重量的8~12倍量,第二次水的用量为药材总重量的6~10倍量,合并2次得到的提取液,过滤后滤液备用;
(2)将得到的滤液浓缩至相对密度为1.06~1.19的清膏,将清膏喷雾干燥成粉后测定麻黄含量,按照测得的麻黄含量加入蔗糖粉,混匀,制得颗粒;
(3)将得到的颗粒干燥后按4g/袋分装,控制麻黄含量为1.80~1.90mg/袋,制得所述的4克装小儿肺热咳喘颗粒。
2.根据权利要求1所述的4克装小儿肺热咳喘颗粒的制备方法,其特征在于,包括如下步骤:
(1)将所述十一味药材混匀后加水煎煮2次,每次煎煮1~3小时,第一次水的用量为药材总重量的9~11倍量,第二次水的用量为药材总重量的7~9倍量,合并2次得到的提取液,过滤后滤液备用;
(2)将得到的滤液浓缩至相对密度为1.10~1.17的清膏,将清膏喷雾干燥成粉后测定麻黄含量,按照测得的麻黄含量加入蔗糖粉,混匀,制得颗粒;
(3)将得到的颗粒干燥后按4g/袋分装,控制麻黄含量为1.85~1.90mg/袋,制得所述的4克装小儿肺热咳喘颗粒。
3.根据权利要求1所述的4克装小儿肺热咳喘颗粒的制备方法,其特征在于,所述步骤(2)中的滤液浓缩在双效节能浓缩器中进行。
4.根据权利要求3所述的4克装小儿肺热咳喘颗粒的制备方法,其特征在于,所述的滤液浓缩条件为:浓缩温度为60~70℃,浓缩真空度为-0.06~-0.08MPa。
5.根据权利要求1所述的4克装小儿肺热咳喘颗粒的制备方法,其特征在于,所述步骤(2)中喷雾干燥在喷雾干燥机中进行。
6.根据权利要求5所述的4克装小儿肺热咳喘颗粒的制备方法,其特征在于,所述喷雾干燥的条件为:控制清膏温度为60~75℃,电机转速为5~10HZ,进风温度为140~160℃,出风温度为80~90℃。
7.根据权利要求1所述的4克装小儿肺热咳喘颗粒的制备方法,其特征在于,所述步骤(3)中干燥时的干燥温度为75~85℃,干燥时间为1~3小时。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201810544136.7A CN108553578A (zh) | 2018-05-30 | 2018-05-30 | 一种4克装小儿肺热咳喘颗粒的制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201810544136.7A CN108553578A (zh) | 2018-05-30 | 2018-05-30 | 一种4克装小儿肺热咳喘颗粒的制备方法 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN108553578A true CN108553578A (zh) | 2018-09-21 |
Family
ID=63552454
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201810544136.7A Pending CN108553578A (zh) | 2018-05-30 | 2018-05-30 | 一种4克装小儿肺热咳喘颗粒的制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN108553578A (zh) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112472749A (zh) * | 2020-12-18 | 2021-03-12 | 天津中新药业集团股份有限公司达仁堂制药厂 | 用于治疗稳定期慢阻肺的中药颗粒剂及其制备方法和用途 |
CN113384650A (zh) * | 2021-06-15 | 2021-09-14 | 海南葫芦娃药业集团股份有限公司 | 一种小儿肺热咳喘颗粒的制备方法 |
CN113687005A (zh) * | 2021-09-17 | 2021-11-23 | 海南葫芦娃药业集团股份有限公司 | 小儿肺热咳喘颗粒中盐酸麻黄碱与盐酸伪麻黄碱的含量测定方法 |
CN113720957A (zh) * | 2021-08-04 | 2021-11-30 | 海南葫芦娃药业集团股份有限公司 | 小儿肺热咳喘颗粒中鱼腥草有效成分的鉴别方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1097320A (zh) * | 1993-07-13 | 1995-01-18 | 四川省中药厂 | 无糖型小儿肺热咳喘冲剂及其制备方法 |
CN101780214A (zh) * | 2010-03-30 | 2010-07-21 | 海南新中正制药有限公司 | 小儿肺热咳喘颗粒的制备方法 |
-
2018
- 2018-05-30 CN CN201810544136.7A patent/CN108553578A/zh active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1097320A (zh) * | 1993-07-13 | 1995-01-18 | 四川省中药厂 | 无糖型小儿肺热咳喘冲剂及其制备方法 |
CN101780214A (zh) * | 2010-03-30 | 2010-07-21 | 海南新中正制药有限公司 | 小儿肺热咳喘颗粒的制备方法 |
Non-Patent Citations (1)
Title |
---|
李海英;等: "小儿肺热咳喘颗粒工艺研究", 《黑龙江科技信息》 * |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112472749A (zh) * | 2020-12-18 | 2021-03-12 | 天津中新药业集团股份有限公司达仁堂制药厂 | 用于治疗稳定期慢阻肺的中药颗粒剂及其制备方法和用途 |
CN113384650A (zh) * | 2021-06-15 | 2021-09-14 | 海南葫芦娃药业集团股份有限公司 | 一种小儿肺热咳喘颗粒的制备方法 |
CN113720957A (zh) * | 2021-08-04 | 2021-11-30 | 海南葫芦娃药业集团股份有限公司 | 小儿肺热咳喘颗粒中鱼腥草有效成分的鉴别方法 |
CN113687005A (zh) * | 2021-09-17 | 2021-11-23 | 海南葫芦娃药业集团股份有限公司 | 小儿肺热咳喘颗粒中盐酸麻黄碱与盐酸伪麻黄碱的含量测定方法 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN108553578A (zh) | 一种4克装小儿肺热咳喘颗粒的制备方法 | |
CN101780214B (zh) | 小儿肺热咳喘颗粒的制备方法 | |
CN107308392A (zh) | 一种玛咖虫草人参代用茶 | |
CN107183276A (zh) | 一种覆盆黄精代用茶 | |
CN110279107A (zh) | 一种参鹿酥油膏及其制备方法 | |
CN101269175B (zh) | 痔舒适洗液的检测方法 | |
CN107333942A (zh) | 一种人参玫瑰代用茶 | |
CN104288234B (zh) | 防治羊呼吸***疾病的中药制剂及其生产方法 | |
CN105963536A (zh) | 一种滋阴降火用的中药组合物及其制备方法 | |
CN111840476A (zh) | 一种治疗流行性感冒的中药组合物、制剂及其制备方法和应用 | |
CN110251610A (zh) | 一种参鞭酥油膏及其制备方法 | |
Ye et al. | Medicinal angiosperms of Scrophulariaceae | |
Ye et al. | Medicinal Angiosperms of Rutaceae | |
Ye et al. | Medicinal Angiosperms of Alangiaceae, Nyssaceae, and Araliaceae | |
Ye et al. | Medicinal Angiosperms of Liliaceae | |
CN103169856B (zh) | 一种含有黄连的中药组合物 | |
CN108434425A (zh) | 一种中药生发配方及其制备方法 | |
Ye et al. | Medicinal Angiosperms of Cruciferae, Violaceae, and Polygalaceae | |
Ye et al. | Medicinal Angiosperms of Ranunculaceae, Nymphaeaceae, and Berberidaceae | |
CN110584188A (zh) | 用于卷烟的复合中草药制剂及其制备方法 | |
Ye et al. | Medicinal Angiosperms of Iridaceae, Stemonaceae, Dioscoreaceae, Agavaceae, Palmae, Pandanaceae, and Hypoxidaceae | |
CN106177863A (zh) | 一种治疗胃寒的中药配方 | |
CN106139105A (zh) | 一种治疗***的中药配方 | |
CN108704040B (zh) | 一种中药组合物及其应用 | |
CN101322781A (zh) | 用于治疗咽喉炎的胶囊 |
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 | ||
RJ01 | Rejection of invention patent application after publication | ||
RJ01 | Rejection of invention patent application after publication |
Application publication date: 20180921 |