CN106806358A - One seed ginseng wheat Neulized inhalation pharmaceutical solutions and preparation method thereof - Google Patents
One seed ginseng wheat Neulized inhalation pharmaceutical solutions and preparation method thereof Download PDFInfo
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- CN106806358A CN106806358A CN201510854859.3A CN201510854859A CN106806358A CN 106806358 A CN106806358 A CN 106806358A CN 201510854859 A CN201510854859 A CN 201510854859A CN 106806358 A CN106806358 A CN 106806358A
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- 238000002360 preparation method Methods 0.000 title claims abstract description 48
- 241000209140 Triticum Species 0.000 title claims abstract description 29
- 235000021307 Triticum Nutrition 0.000 title claims abstract description 29
- 241000208340 Araliaceae Species 0.000 title claims abstract description 19
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 title claims abstract description 19
- 235000003140 Panax quinquefolius Nutrition 0.000 title claims abstract description 19
- 235000008434 ginseng Nutrition 0.000 title claims abstract description 19
- 239000003186 pharmaceutical solution Substances 0.000 title claims abstract description 13
- 239000004480 active ingredient Substances 0.000 claims abstract description 33
- 239000007951 isotonicity adjuster Substances 0.000 claims abstract description 7
- 239000007853 buffer solution Substances 0.000 claims abstract description 5
- 239000002904 solvent Substances 0.000 claims abstract description 3
- 239000000243 solution Substances 0.000 claims description 82
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 47
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 44
- 229940041682 inhalant solution Drugs 0.000 claims description 20
- 239000000706 filtrate Substances 0.000 claims description 12
- 239000000443 aerosol Substances 0.000 claims description 9
- 239000000284 extract Substances 0.000 claims description 9
- 240000002948 Ophiopogon intermedius Species 0.000 claims description 7
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 6
- 238000001914 filtration Methods 0.000 claims description 6
- 238000004064 recycling Methods 0.000 claims description 6
- 239000011734 sodium Substances 0.000 claims description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 5
- -1 is filtered Substances 0.000 claims description 5
- 229910052708 sodium Inorganic materials 0.000 claims description 5
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims description 4
- 235000002789 Panax ginseng Nutrition 0.000 claims description 4
- 229940089161 ginsenoside Drugs 0.000 claims description 4
- 229930182494 ginsenoside Natural products 0.000 claims description 4
- 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 claims description 3
- 238000012869 ethanol precipitation Methods 0.000 claims description 3
- 235000020710 ginseng extract Nutrition 0.000 claims description 3
- 238000010992 reflux Methods 0.000 claims description 3
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- 239000001110 calcium chloride Substances 0.000 claims description 2
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- 239000001257 hydrogen Substances 0.000 claims description 2
- 229910052739 hydrogen Inorganic materials 0.000 claims description 2
- 229910001629 magnesium chloride Inorganic materials 0.000 claims description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 2
- BUCIWTBCUUHRHZ-UHFFFAOYSA-K potassium;disodium;dihydrogen phosphate;hydrogen phosphate Chemical compound [Na+].[Na+].[K+].OP(O)([O-])=O.OP([O-])([O-])=O BUCIWTBCUUHRHZ-UHFFFAOYSA-K 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- IGHGOYDCVRUTSU-UHFFFAOYSA-M sodium;2-hydroxypropane-1,2,3-tricarboxylic acid;hydroxide Chemical compound [OH-].[Na+].OC(=O)CC(O)(C(O)=O)CC(O)=O IGHGOYDCVRUTSU-UHFFFAOYSA-M 0.000 claims description 2
- 239000000811 xylitol Substances 0.000 claims description 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 2
- 229960002675 xylitol Drugs 0.000 claims description 2
- 235000010447 xylitol Nutrition 0.000 claims description 2
- 239000003182 parenteral nutrition solution Substances 0.000 claims 2
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 claims 1
- 235000005979 Citrus limon Nutrition 0.000 claims 1
- 244000131522 Citrus pyriformis Species 0.000 claims 1
- 235000002710 Ilex cornuta Nutrition 0.000 claims 1
- 241001310146 Ilex cornuta Species 0.000 claims 1
- 235000010326 Osmanthus heterophyllus Nutrition 0.000 claims 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 239000000460 chlorine Substances 0.000 claims 1
- 229910052801 chlorine Inorganic materials 0.000 claims 1
- 239000011591 potassium Substances 0.000 claims 1
- 229910052700 potassium Inorganic materials 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 15
- 238000002347 injection Methods 0.000 abstract description 14
- 239000007924 injection Substances 0.000 abstract description 14
- 239000008862 fructus schizandrae, radix ginseng, radix ophiopogonis drug combination Substances 0.000 abstract description 13
- 238000000034 method Methods 0.000 abstract description 6
- 239000008215 water for injection Substances 0.000 description 43
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 24
- 238000003756 stirring Methods 0.000 description 22
- 239000012467 final product Substances 0.000 description 11
- 238000007789 sealing Methods 0.000 description 11
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 9
- 238000011049 filling Methods 0.000 description 9
- 238000005660 chlorination reaction Methods 0.000 description 8
- 206010067484 Adverse reaction Diseases 0.000 description 5
- 230000006838 adverse reaction Effects 0.000 description 5
- 208000029078 coronary artery disease Diseases 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000013641 positive control Substances 0.000 description 4
- 208000009525 Myocarditis Diseases 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 230000001684 chronic effect Effects 0.000 description 3
- 230000007812 deficiency Effects 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 230000035939 shock Effects 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- 201000010000 Agranulocytosis Diseases 0.000 description 2
- 201000006306 Cor pulmonale Diseases 0.000 description 2
- SRBFZHDQGSBBOR-IOVATXLUSA-N D-xylopyranose Chemical compound O[C@@H]1COC(O)[C@H](O)[C@H]1O SRBFZHDQGSBBOR-IOVATXLUSA-N 0.000 description 2
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000011777 magnesium Substances 0.000 description 2
- 229910052749 magnesium Inorganic materials 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 206010002199 Anaphylactic shock Diseases 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 206010067482 No adverse event Diseases 0.000 description 1
- 206010033661 Pancytopenia Diseases 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- PYMYPHUHKUWMLA-UHFFFAOYSA-N arabinose Natural products OCC(O)C(O)C(O)C=O PYMYPHUHKUWMLA-UHFFFAOYSA-N 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 238000000889 atomisation Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- SRBFZHDQGSBBOR-UHFFFAOYSA-N beta-D-Pyranose-Lyxose Natural products OC1COC(O)C(O)C1O SRBFZHDQGSBBOR-UHFFFAOYSA-N 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 235000013339 cereals Nutrition 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 208000024389 cytopenia Diseases 0.000 description 1
- CBMPTFJVXNIWHP-UHFFFAOYSA-L disodium;hydrogen phosphate;2-hydroxypropane-1,2,3-tricarboxylic acid Chemical compound [Na+].[Na+].OP([O-])([O-])=O.OC(=O)CC(O)(C(O)=O)CC(O)=O CBMPTFJVXNIWHP-UHFFFAOYSA-L 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 238000011552 rat model Methods 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- XPFJYKARVSSRHE-UHFFFAOYSA-K trisodium;2-hydroxypropane-1,2,3-tricarboxylate;2-hydroxypropane-1,2,3-tricarboxylic acid Chemical compound [Na+].[Na+].[Na+].OC(=O)CC(O)(C(O)=O)CC(O)=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O XPFJYKARVSSRHE-UHFFFAOYSA-K 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
-
- 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)
- A61K36/88—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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- 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
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- 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
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- 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
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a seed ginseng wheat Neulized inhalation pharmaceutical solutions, belong to galenic pharmacy field.The Neulized inhalation pharmaceutical solutions of one seed ginseng wheat, including (1) ginseng wheat active ingredient；(2) isotonic agent and solvent, can also include buffer solution.Pharmaceutical solutions prepared by the present invention compensate for the blank on domestic market, can prevent due to a lack of the special preparation medicine of Inhalation in Treating, the safety risks for being substituted for Inhalation in Treating using Shenmai injection and producing.And pharmaceutical solutions prepared by the present invention is to aim at Neulized inhalation to be designed with patient, is supported the use with atomizer, convenient using process, compared with Shenmai injection, method of administration is different, and dosage is reduced, and security is improved.
Description
Technical field
The present invention relates to seed ginseng wheat Neulized inhalation pharmaceutical solutions and preparation method thereof, belong to galenic pharmacy field.
Background technology
Shenmai injection is made up of medicines such as red ginseng, the tubers of dwarf lilyturf, is taken off admittedly with QI invigorating, nourishing Yin and promoting production of body fluid, raw arteries and veins
Effect, clinically for treating shock, coronary heart disease, vital myocarditis, the chronic pulmonary of type of deficiency of both QI and YIN
Worry, agranulocytosis etc..
Recently as the increase of clinical application crowd, its Reporting of harms is also increasing, is mainly manifested in
The serious adverse reactions such as anaphylactic shock, respiratory tract obstruction.It would therefore be highly desirable to develop a kind of safer agent
Type, reduces adverse reaction, improves clinical application safety.
The content of the invention
The present invention solves the technical problem of provide it is a kind of safely, effectively, the atomization of the ginseng wheat of good quality
Suction pharmaceutical solutions；Present invention also offers the preparation method of said preparation.
The present invention is achieved by the following technical solutions：
One seed ginseng wheat Neulized inhalation pharmaceutical solutions, including：
(1) wheat active ingredient is joined；
(2) isotonic agent and solvent；
Buffer solution can also be added.
Wherein, in terms of ginsenoside, active ingredient is 1: 1-1: 5 with the mass ratio of isotonic agent.
Heretofore described Neulized inhalation preparation include the pharmaceutical dosages of the 8-50mg in terms of ginsenoside it is effective into
Point.
Active ingredient is prepared obtaining：
1 part of red ginseng, 2 parts of the tuber of dwarf lilyturf
Ginseng is washed and chopped, plus 75% alcohol reflux is extracted 4 times, each 2h, merges extract solution, is filtered,
Filtrate recycling ethanol is to without alcohol taste, and when being concentrated into 50 DEG C, relative density is 1.20, plus ethanol reaches alcohol content
85%, 48h is stood, filtration, filtrate recycling ethanol is standby to without alcohol taste；It is another to take after the tuber of dwarf lilyturf cleans, add water
Extract 3 times, each 1h, merge extract solution, filtration, it is 1.20 that filtrate is concentrated into 50 DEG C of relative densities, plus
Enter ethanol precipitation 2 times, alcohol content up to 75%, 85% is made respectively, 24h is stood respectively, filter, filtrate is reclaimed
Ethanol mixes to without alcohol taste with above-mentioned Ginseng extract, obtains active ingredient of the invention.
Isotonic agent is in sodium chloride, potassium chloride, magnesium chloride, calcium chloride, glucose, xylitol, sorbierite
One kind.
Buffer solution be citric acid-sodium citrate, citrate-phosphate disodium hydrogen, potassium dihydrogen phosphate-disodium hydrogen phosphate,
One kind in citric acid-sodium hydroxide, citric acid-disodium hydrogen phosphate.
The pH value of aerosol inhalation solution is 3.0-8.5；Preferable ph is 4.0-7.0.
The consumption of aerosol inhalation solution is 0.1-0.8 times of Shenmai injection consumption；Preferable amount is ginseng wheat note
Penetrate liquid consumption 0.3-0.6 times.
It is of the present invention ginseng wheat Neulized inhalation pharmaceutical solutions can be used for treat type of deficiency of both QI and YIN shock,
Coronary heart disease, vital myocarditis, chronic cardiopulmonary disease, agranulocytosis etc..
It is an advantage of the present invention to provide a kind of novel form better than Shenmai injection, said preparation is directly by breathing
Road suck, in localized clusters into higher concentration, and directly act on airway surface receptor or target acceptor and
Play a role, and can directly be absorbed from air flue mucous membrane and lung, the administering mode can be direct by effective component
Focus is delivered to, safely and effectively, bioavilability is high, low dosage can be realized and fast and effectively treated,
Thus have a clear superiority.
Pharmaceutical solutions prepared by the present invention compensate for the blank on domestic market, can prevent due to a lack of suction
Enter to treat special preparation medicine, the security for being substituted for Inhalation in Treating using Shenmai injection and producing is hidden
Suffer from.It is supporting with atomizer to make and pharmaceutical solutions prepared by the present invention is to aim at Neulized inhalation to be designed with patient
With convenient using process, compared with Shenmai injection, method of administration is different, and dosage is reduced, safety
Property improve.
Beneficial effects of the present invention are further illustrated below by way of test example：
Prepare coronary heart disease rat model 60, be randomly divided into Normal group, positive controls, medicine group one,
Medicine group two, medicine group three, medicine group four, every group 10, wherein, Normal group gives normal
Saline IV；Positive controls give Shenmai injection intravenous injection；Medicine group one, two, three, four
Give respectively ginseng wheat aerosol inhalation solution (consumption be respectively 0.1 times of Shenmai injection, 0.3 times, 0.6 times,
0.8 times), successive administration 3 days, observation by after treatment, the cure rate of each group, adverse reaction rate,
And the peak concentration of drug after last dose in lung tissue and blood.Specifically see the table below：
Situation after the treatment of table each group
It can thus be seen that each medicine group has preferable therapeutic action, wherein medicine group to coronary heart disease rat
2nd, three, four therapeutic effect is substantially better than positive controls, and medicine group one is equivalent with positive controls, and
There is no adverse reaction.
In summary, medicine group dosage is small, and adverse reaction is few, and medicine it is main lung be gathered into compared with
High concentration, is conducive to effective component to directly act on focus, and bioavilability is high, realizes low dosage and fast
Fast effective treatment, thus have a clear superiority.
Equally, shock, vital myocarditis, chronic cardiopulmonary disease, grain of the medicine group in treatment type of deficiency of both QI and YIN
The effect of cytopenia etc. is also significantly better than Shenmai injection.
The therapeutic effect of present invention ginseng wheat aerosol inhalation solution is substantially better than Shenmai injection, has filled up current state
The blank of the ginseng special aerosol inhalation solution of wheat of interior in the market, compared with Shenmai injection, dosage is significantly
Reduce, be 0.1-0.8 times of Shenmai injection, preferably 0.3-0.6 times, while method of administration is changed,
The generation of adverse reaction is reduced, therefore, the present invention possesses creative and prominent substantive distinguishing features and significant
It is progressive.
Specific embodiment
The consumption of the production process of following pharmaceutical preparation embodiment and material used by preparation or material used by preparation is not
It is limited to character express, the formulation method of all pharmaceutical compositions provided containing the present invention is belonged to of the invention
Protection domain.
Embodiment 1
(1) preparation of active ingredient：
1 part of red ginseng, 2 parts of the tuber of dwarf lilyturf
Ginseng is washed and chopped, plus 75% alcohol reflux is extracted 4 times, each 2h, merges extract solution, is filtered,
Filtrate recycling ethanol is to without alcohol taste, and when being concentrated into 50 DEG C, relative density is 1.20, plus ethanol reaches alcohol content
85%, 48h is stood, filtration, filtrate recycling ethanol is standby to without alcohol taste；It is another to take after the tuber of dwarf lilyturf cleans, add water
Extract 3 times, each 1h, merge extract solution, filtration, it is 1.20 that filtrate is concentrated into 50 DEG C of relative densities, plus
Enter ethanol precipitation 2 times, alcohol content up to 75%, 85% is made respectively, 24h is stood respectively, filter, filtrate is reclaimed
Ethanol mixes to without alcohol taste with above-mentioned Ginseng extract, obtains active ingredient of the invention.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.4mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 5.0-7.0, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 2
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium, adds appropriate water for injection, is stirred to dissolve, and obtains solution 2；Solution 1 and solution is 2-in-1 simultaneously, stirring
Uniformly, solution 3 is obtained；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to the molten of 0.4mol/L
Liquid, stirring is slowly added into solution 3, regulation pH value to 4.0-7.0, plus water for injection 1000ml, is filled
Dress, sealing, obtain final product.
Embodiment 3
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Magnesium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.2mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 5.0-6.0, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 4
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Calcium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.4mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 5.0-6.5, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 5
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another sodium citrate that takes is appropriate, plus appropriate water for injection is configured to 0.4mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 6.0-7.0, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 6
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take grape
Sugar and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.4mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 4.5-5.5, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 7
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take xylose
Alcohol and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；It is another to take Sodium hydroxide q. s, plus water for injection is configured to 0.1mol/L in right amount
Solution, stirring be slowly added into solution 3, regulation pH value to 3.0-5.0, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 8
(1) preparation of active ingredient：Preparation method is with embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium and potassium dihydrogen phosphate, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；By solution 1 and solution
It is 2-in-1 simultaneously to stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to
The solution of 0.4mol/L, stirring is slowly added into solution 3, regulation pH value to 7.5-8.5, plus injection
Water 1000ml, filling, sealing is obtained final product.
Embodiment 9
(1) preparation of active ingredient：Preparation method is with embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take sorb
Alcohol and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.2mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 5.0-6.0, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 10
(1) preparation of active ingredient：Preparation method is with embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.2mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 5.0-6.5, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 11
(1) preparation of active ingredient：Preparation method is with embodiment 1.
(2) preparation of wheat Neulized inhalation solution is joined：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Magnesium, adds appropriate water for injection, is stirred to dissolve, and obtains solution 2；Solution 1 and solution is 2-in-1 simultaneously, stirring
Uniformly, solution 3 is obtained；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to the molten of 0.4mol/L
Liquid, stirring is slowly added into solution 3, regulation pH value to 6.5-8.5, plus water for injection 1000ml, is filled
Dress, sealing, obtain final product.
Claims (10)
1. a seed ginseng wheat Neulized inhalation pharmaceutical solutions, it is characterised in that join wheat active ingredient including (1)；
(2) isotonic agent and solvent；
In terms of ginsenoside, active ingredient is 1: 1-1: 5 with the mass ratio of isotonic agent.
2. preparation according to claim 1, it is characterised in that described Neulized inhalation preparation include with
The active ingredient of ginsenoside meter 8-50mg pharmaceutical dosages.
3. preparation according to claim 1 and 2, it is characterised in that active ingredient is to be prepared
Arrive：
1 part of red ginseng, 2 parts of the tuber of dwarf lilyturf
Ginseng is washed and chopped, plus 75% alcohol reflux is extracted 4 times, each 2h, merges extract solution, is filtered,
Filtrate recycling ethanol is to without alcohol taste, and when being concentrated into 50 DEG C, relative density is 1.20, plus ethanol reaches alcohol content
85%, 48h is stood, filtration, filtrate recycling ethanol is standby to without alcohol taste；It is another to take after the tuber of dwarf lilyturf cleans, add water
Extract 3 times, each 1h, merge extract solution, filtration, it is 1.20 that filtrate is concentrated into 50 DEG C of relative densities, plus
Enter ethanol precipitation 2 times, alcohol content up to 75%, 85% is made respectively, 24h is stood respectively, filter, filtrate is reclaimed
Ethanol mixes to without alcohol taste with above-mentioned Ginseng extract, obtains active ingredient of the invention.
4. preparation according to claim 1, it is characterised in that described isotonic agent is sodium chloride, chlorine
Change the one kind in potassium, magnesium chloride, calcium chloride, glucose, xylitol, sorbierite.
5. preparation according to claim 1, it is characterised in that also include buffer solution in said preparation.
6. preparation according to claim 5, it is characterised in that described buffer solution is citric acid-lemon
Lemon acid sodium, citrate-phosphate disodium hydrogen, potassium dihydrogen phosphate-disodium hydrogen phosphate, citric acid-sodium hydroxide, Chinese holly
One kind in rafter acid-disodium hydrogen phosphate.
7. preparation according to claim 1, it is characterised in that the pH value of aerosol inhalation solution is
3.0-8.5。
8. preparation according to claim 7, it is characterised in that the pH value of aerosol inhalation solution is
4.0-7.0。
9. preparation according to claim 1, it is characterised in that the consumption of aerosol inhalation solution is ginseng wheat
0.1-0.8 times of parenteral solution consumption.
10. preparation according to claim 9, it is characterised in that the consumption of aerosol inhalation solution is ginseng
0.3-0.6 times of wheat parenteral solution consumption.
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Cited By (4)
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| CN107648207A (en) * | 2017-10-11 | 2018-02-02 | 北京北朋科技有限公司 | Neulized inhalation citrate sugar alcohol solution |
| CN109745441A (en) * | 2017-11-03 | 2019-05-14 | 北京盈科瑞创新药物研究有限公司 | One seed ginseng wheat stops Neulized inhalation pharmaceutical solutions and preparation method thereof of coughing |
| CN109745352A (en) * | 2017-11-03 | 2019-05-14 | 北京盈科瑞创新药物研究有限公司 | A kind of gingko seed beverage Neulized inhalation pharmaceutical solutions and preparation method thereof |
| CN109771398A (en) * | 2019-02-25 | 2019-05-21 | 广州南鑫药业有限公司 | A kind of Peramivir solution-type inhalant and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107648207A (en) * | 2017-10-11 | 2018-02-02 | 北京北朋科技有限公司 | Neulized inhalation citrate sugar alcohol solution |
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| CN109745441A (en) * | 2017-11-03 | 2019-05-14 | 北京盈科瑞创新药物研究有限公司 | One seed ginseng wheat stops Neulized inhalation pharmaceutical solutions and preparation method thereof of coughing |
| CN109745352A (en) * | 2017-11-03 | 2019-05-14 | 北京盈科瑞创新药物研究有限公司 | A kind of gingko seed beverage Neulized inhalation pharmaceutical solutions and preparation method thereof |
| CN109771398A (en) * | 2019-02-25 | 2019-05-21 | 广州南鑫药业有限公司 | A kind of Peramivir solution-type inhalant and preparation method thereof |
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Address after: Double camp 102299 West Road Beijing city Changping District Science Park No. 79, No. 24 building 6 layer cloud Valley Park Applicant after: Beijing Increasepharm Co.,Ltd. Address before: 100088 Beijing city Xicheng District, New Street No. 2 Tiancheng Technology building block B room 4002 Applicant before: BEIJING INCREASE PHARMACEUTICAL INSTITUTE Co.,Ltd. |
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Effective date of registration: 20201113 Address after: 102299 5th floor 506, Building 24, Yungu Garden, 79 Shuangying West Road, Changping District, Beijing Applicant after: BEIJING INCREASE INNOVATIVE DRUG Co.,Ltd. Address before: 102299 Six Floors, Building 24, Yungu Garden, No. 79 Shuangying West Road, Changping District Science and Technology Park, Beijing Applicant before: Beijing Increasepharm Co.,Ltd. |
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Application publication date: 20170609 |