CN109453127A - A kind of the freeze-drying of ching-chieh volatile oil molten, mouth and preparation method thereof - Google Patents
A kind of the freeze-drying of ching-chieh volatile oil molten, mouth and preparation method thereof Download PDFInfo
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- CN109453127A CN109453127A CN201811525276.6A CN201811525276A CN109453127A CN 109453127 A CN109453127 A CN 109453127A CN 201811525276 A CN201811525276 A CN 201811525276A CN 109453127 A CN109453127 A CN 109453127A
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- volatile oil
- chieh
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- 239000000341 volatile oil Substances 0.000 title claims abstract description 65
- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- 238000004108 freeze drying Methods 0.000 title claims abstract description 16
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims abstract description 12
- 150000001875 compounds Chemical class 0.000 claims abstract description 12
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 12
- 125000003118 aryl group Chemical group 0.000 claims abstract description 9
- 235000003599 food sweetener Nutrition 0.000 claims abstract description 9
- 239000003765 sweetening agent Substances 0.000 claims abstract description 9
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 38
- 238000004321 preservation Methods 0.000 claims description 19
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 14
- 239000000243 solution Substances 0.000 claims description 14
- 229960004756 ethanol Drugs 0.000 claims description 12
- 229920006395 saturated elastomer Polymers 0.000 claims description 12
- 239000007864 aqueous solution Substances 0.000 claims description 11
- 238000002156 mixing Methods 0.000 claims description 7
- 108010011485 Aspartame Proteins 0.000 claims description 6
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 6
- 229930195725 Mannitol Natural products 0.000 claims description 6
- 239000000605 aspartame Substances 0.000 claims description 6
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 6
- 235000010357 aspartame Nutrition 0.000 claims description 6
- 229960003438 aspartame Drugs 0.000 claims description 6
- 239000000594 mannitol Substances 0.000 claims description 6
- 235000010355 mannitol Nutrition 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 6
- 238000004806 packaging method and process Methods 0.000 claims description 6
- 239000008213 purified water Substances 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 108010010803 Gelatin Proteins 0.000 claims description 5
- 239000008273 gelatin Substances 0.000 claims description 5
- 229920000159 gelatin Polymers 0.000 claims description 5
- 235000019322 gelatine Nutrition 0.000 claims description 5
- 235000011852 gelatine desserts Nutrition 0.000 claims description 5
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 3
- 240000008790 Musa x paradisiaca Species 0.000 claims description 3
- 235000018290 Musa x paradisiaca Nutrition 0.000 claims description 3
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims description 3
- 239000004376 Sucralose Substances 0.000 claims description 3
- 235000010489 acacia gum Nutrition 0.000 claims description 3
- 239000001785 acacia senegal l. willd gum Substances 0.000 claims description 3
- 239000008101 lactose Substances 0.000 claims description 3
- 235000019408 sucralose Nutrition 0.000 claims description 3
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims description 3
- 235000010493 xanthan gum Nutrition 0.000 claims description 3
- 239000000230 xanthan gum Substances 0.000 claims description 3
- 229920001285 xanthan gum Polymers 0.000 claims description 3
- 229940082509 xanthan gum Drugs 0.000 claims description 3
- 235000005979 Citrus limon Nutrition 0.000 claims description 2
- 244000131522 Citrus pyriformis Species 0.000 claims description 2
- 244000241257 Cucumis melo Species 0.000 claims description 2
- 235000015510 Cucumis melo subsp melo Nutrition 0.000 claims description 2
- 229920002307 Dextran Polymers 0.000 claims description 2
- 235000016623 Fragaria vesca Nutrition 0.000 claims description 2
- 240000009088 Fragaria x ananassa Species 0.000 claims description 2
- 235000011363 Fragaria x ananassa Nutrition 0.000 claims description 2
- 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 description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- FJJCIZWZNKZHII-UHFFFAOYSA-N [4,6-bis(cyanoamino)-1,3,5-triazin-2-yl]cyanamide Chemical compound N#CNC1=NC(NC#N)=NC(NC#N)=N1 FJJCIZWZNKZHII-UHFFFAOYSA-N 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 claims description 2
- 238000010438 heat treatment Methods 0.000 claims description 2
- 235000012907 honey Nutrition 0.000 claims description 2
- 238000005057 refrigeration Methods 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims 1
- 238000007710 freezing Methods 0.000 claims 1
- 230000008014 freezing Effects 0.000 claims 1
- 238000005406 washing Methods 0.000 claims 1
- 238000005303 weighing Methods 0.000 claims 1
- 229920000858 Cyclodextrin Polymers 0.000 abstract description 6
- 238000000034 method Methods 0.000 abstract description 6
- -1 HP- β-CD Substances 0.000 abstract description 3
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical group CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 abstract 1
- 239000001116 FEMA 4028 Substances 0.000 abstract 1
- 235000011175 beta-cyclodextrine Nutrition 0.000 abstract 1
- 229960004853 betadex Drugs 0.000 abstract 1
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 1
- 210000000214 mouth Anatomy 0.000 description 14
- 239000003814 drug Substances 0.000 description 7
- 229940079593 drug Drugs 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 5
- 239000000463 material Substances 0.000 description 4
- 210000003800 pharynx Anatomy 0.000 description 4
- 238000001291 vacuum drying Methods 0.000 description 4
- 239000000796 flavoring agent Substances 0.000 description 3
- 235000019634 flavors Nutrition 0.000 description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 2
- 235000009754 Vitis X bourquina Nutrition 0.000 description 2
- 235000012333 Vitis X labruscana Nutrition 0.000 description 2
- 240000006365 Vitis vinifera Species 0.000 description 2
- 235000014787 Vitis vinifera Nutrition 0.000 description 2
- 206010000269 abscess Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- 230000003993 interaction Effects 0.000 description 2
- BBEAQIROQSPTKN-UHFFFAOYSA-N pyrene Chemical compound C1=CC=C2C=CC3=CC=CC4=CC=C1C2=C43 BBEAQIROQSPTKN-UHFFFAOYSA-N 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- FZWBNHMXJMCXLU-UHFFFAOYSA-N 2,3,4,5-tetrahydroxy-6-[3,4,5-trihydroxy-6-[[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxymethyl]oxan-2-yl]oxyhexanal Chemical compound OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OCC(O)C(O)C(O)C(O)C=O)O1 FZWBNHMXJMCXLU-UHFFFAOYSA-N 0.000 description 1
- 241001164374 Calyx Species 0.000 description 1
- 241001573881 Corolla Species 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 208000012671 Gastrointestinal haemorrhages Diseases 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
- 208000034507 Haematemesis Diseases 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 206010062717 Increased upper airway secretion Diseases 0.000 description 1
- 241000207923 Lamiaceae Species 0.000 description 1
- 201000005505 Measles Diseases 0.000 description 1
- 206010027514 Metrorrhagia Diseases 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 241000951473 Schizonepeta Species 0.000 description 1
- 238000005411 Van der Waals force Methods 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 230000003110 anti-inflammatory effect 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
- 230000009286 beneficial effect Effects 0.000 description 1
- 229950005162 benexate Drugs 0.000 description 1
- 235000010290 biphenyl Nutrition 0.000 description 1
- 208000034158 bleeding Diseases 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 239000003610 charcoal Substances 0.000 description 1
- IAXUQWSLRKIRFR-SAABIXHNSA-N chembl2104696 Chemical compound C1C[C@@H](CNC(=N)N)CC[C@@H]1C(=O)OC1=CC=CC=C1C(=O)OCC1=CC=CC=C1 IAXUQWSLRKIRFR-SAABIXHNSA-N 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- ZUOUZKKEUPVFJK-UHFFFAOYSA-N diphenyl Chemical compound C1=CC=CC=C1C1=CC=CC=C1 ZUOUZKKEUPVFJK-UHFFFAOYSA-N 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- GVEPBJHOBDJJJI-UHFFFAOYSA-N fluoranthrene Natural products C1=CC(C2=CC=CC=C22)=C3C2=CC=CC3=C1 GVEPBJHOBDJJJI-UHFFFAOYSA-N 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 208000035861 hematochezia Diseases 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 206010033675 panniculitis Diseases 0.000 description 1
- 208000026435 phlegm Diseases 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 210000000697 sensory organ Anatomy 0.000 description 1
- 208000017520 skin disease Diseases 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 210000004304 subcutaneous tissue Anatomy 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 239000011800 void material Substances 0.000 description 1
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- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K36/538—Schizonepeta
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
Invention is related to field of pharmaceutical preparations, and the present invention relates to a kind of ching-chieh volatile oil to be lyophilized molten, mouth and preparation method thereof, and it includes ching-chieh volatile oil, HP- β-CD, excipients, sweetener, aromatic which, which is lyophilized molten component of mouth,.Preparation method is to prepare ching-chieh volatile oil beta cyclodextrin inclusion complex by using paddling process, after then dissolving inclusion compound, excipients, sweetener, aromatic etc. is added, freeze-drying is prepared into freeze-drying molten, mouth.The molten tablet quality of ching-chieh volatile oil prepared by the present invention freeze-drying mouth is stable, without bad smell, it is convenient to take, absorb rapidly, it is rapid-action.
Description
Technical field
The present invention relates to a kind of ching-chieh volatile oil to be lyophilized molten, mouth and preparation method thereof.
Background technique
Ching-chieh is the flower spike of Lamiaceae plant schizonepeta, is spike wheel umbrella inflorescence, is about 0.5cm, irregular segment.Corolla
It falls off more, place calyx mitriform, 5 fissure of apex, light brown or yellow green, by pubescence.Pyrene brownish black.Ching-chieh aroma
Strong, slightly warm in nature, acrid flavour enters liver, lung channel, be usually used in treat anemofrigid cold, headache, abscess of throat, morbilli, rubeola, sore from the beginning of
Deng for a kind of extremely common expelling wind to resolve the exterior Chinese medicine of tcm clinical practice.With regulating blood condition, calmness, analgesia, it is anti-inflammatory, stop blooding, remove phlegm, flat
The effects of breathing heavily, is anti-oxidant cures mainly cold, fever, abscess of throat etc. and a variety of skin diseases, and hemostasia effect is aobvious after stir-fry charcoal
Write, often haematemesis, bleeding from five sense organs or subcutaneous tissue, hematochezia, metrorrhagia and metrostaxis, in terms of play a role, be tcm clinical practice common drug.
Ching-chieh containing volatile oil be it is faint yellow, have special odor, the influence to air, daylight and temperature is more sensitive, is easy to
The disadvantages of decomposed metamorphic is easily vaporized and aoxidizes, and is difficult to control there are stability difference and product quality.Cyclodextrin of volatile oil includes skill
Art refers to that volatile oil is contained the technology that inclusion compound is formed in the void structure of cyclodextrin.There are weak phases between cyclodextrin and drug
The synergistic effect such as interaction such as Van der Waals force, dipole-dipole interaction, electric charge transfer effect, hydrogen bond, hydrophobic effect, forms
Ultra micro cryptomere inclusion compound.After inclusion essential oil, thus it is possible to vary the physicochemical property of volatile oil improves its stability, covers bad gas
Taste reduces irritation；Inclusion compound can increase volatilization oil solubility, improve the bioavilability of preparation, improve drug in vivo
Absorption, mitigate toxic side effect.Cyclodextrin of volatile oil inclusion compound can be made into the regular dosage forms such as Chinese medicinal tablet, capsule, granule,
But these dosage forms need to be delivered with water, it is not easy to gulp down for dysphagia and the inconvenient children that fetch water, old human patient
Pharynx, patient's poor compliance.Therefore need to develop a kind of stabilization for being not required to be delivered with water, be easy to swallow, can take whenever and wherever possible
Preparation is very important.
Summary of the invention
The object of the present invention is to provide a kind of ching-chieh volatile oil freeze-drying molten of mouth and its preparation method.Solve existing skill
The problem of height of bioavilability existing for art, patient's poor compliance.This method prepares ching-chieh volatile oil by using paddling process
After then dissolving inclusion compound, excipients, sweetener, aromatic etc. is added in Benexate Hydrochloride, and freeze-drying is prepared into freeze-drying
Molten of mouth.The preparation method not only increases the stability of volatile oil, covers pessimal stimulation smell；Drug is improved simultaneously
Water solubility works rapidly, and the bioavilability of preparation is high, and convenient to take, patient is easy to receive.
The solution adopted by the present invention to solve the technical problem is that a kind of ching-chieh volatile oil is lyophilized molten, mouth, by weight
It is composed of the following components:
The preferred 80-100g of excipients in above-mentioned pharmaceutic adjuvant is selected from gelatin, Arabic gum, xanthan gum, dextrose
Acid anhydride, lactose, sorbierite, a kind of either two kinds or more of mixture, the preferably mixture of mannitol and gelatin in mannitol.
The preferred 1-2g of sweetener in above-mentioned pharmaceutic adjuvant is selected from Steviosin, Sucralose, Aspartame, sucrose, honey
A kind of middle either two kinds or more of mixture, preferably aspartame.
Aromatic 0.5-1g in above-mentioned pharmaceutic adjuvant is selected from Hami melon essence, flavoring orange essence, strawberry essence, lemonene
Essence, flavoring banana essence, a kind of either two kinds or more of mixture, preferably flavoring orange essence in grape powdered flavor.
Above-mentioned ching-chieh volatile oil be lyophilized molten, mouth the preparation method comprises the following steps:
1) ching-chieh volatile oil is dissolved in dehydrated alcohol, volatile oil/ethanol solution is made；Volatile oil/dehydrated alcohol is molten
Volume ratio is 1:1；
2) a certain amount of HP- β-CD is weighed, suitable quantity of water is added, dissolves by heating, HP- β-CD saturated aqueous solution is made；
3) it will volatilize oily ethanol solution to be added in HP- β-CD saturated aqueous solution, packet stirred at 40-50 DEG C of constant temperature
It closes, mixing speed 200-400r/min, the inclusion time is 2-4h, and the ratio of HP- β-CD and volatile oil is 6:1 (g/ml)；
4) step 3 inclusion compound being cooled to room temperature, 3 DEG C of -8 DEG C of refrigeration 12h-24h, is filtered, dehydrated alcohol washs 3-5 times,
Each dosage 5mL-10mL；40 DEG C are dried in vacuo -36h for 24 hours, obtain ching-chieh volatile oil beta-CD inclusion；
5) it by ching-chieh volatile oil beta-CD inclusion, is dissolved with purified water, excipients, sweetener, aromatic stirring is added
Dissolution, be added mold in, freeze-drying, press mold, packaging to get.
Compared with prior art, the invention has the following beneficial effects:
The present invention combines cyclodextrin encapsulated technique and freeze drying process, not only increases the stability of volatile oil,
Cover pessimal stimulation smell；When preparing molten, mouth using freeze-drying simultaneously, without adding disintegrating agent, preparation process is simple
Feasible, preparation obtained has obvious skeleton structure character, is disintegrated rapidly in the oral cavity, without grittiness, to overcome use
Conventional compression preparation tablet be disintegrated in the oral cavity slowly, have the shortcomings that grittiness.Meanwhile this mouthful of molten convenient to take, patient
It is easy to receive, drug can be absorbed into blood by mucous membrane of mouth, pharynx and oesophagus biomembrane, work rapidly, improve biological benefit
Expenditure improves the absorption of drug in vivo, mitigates toxic side effect.
Specific embodiment
The present invention is described in further detail for following embodiments, but a specific embodiment of the invention is not limited to
This.
A kind of embodiment 1: the freeze-drying of ching-chieh volatile oil molten, mouth preparation
(1) component
(2) preparation method
1) ching-chieh is added to the water of 8 times of medicinal material amounts, 2h is distilled, obtains ching-chieh volatile oil；2) by ching-chieh volatile oil
It is dissolved in dehydrated alcohol, volatile oil/ethanol solution (volume ratio 1:1) is made；3) HP- β-CD saturated aqueous solution, HP- β-CD are prepared
Ratio with volatile oil is 6:1 (g/ml)；4) it will volatilize oily ethanol solution to be added in HP- β-CD saturated aqueous solution, it is permanent
It is stirred at 40 DEG C of temperature, mixing speed 300r/min, the inclusion time is 3h；5) step 4 inclusion compound is cooled to room temperature, 4 DEG C cold
Hiding for 24 hours, filters, and dehydrated alcohol washs 3 times, each dosage 10mL.40 DEG C of vacuum drying for 24 hours, obtain ching-chieh volatile oil beta-CD packet
Close object；6) it by ching-chieh volatile oil beta-CD inclusion, is dissolved with purified water, sorbierite, Steviosin, grape powdered flavor is added
Stirring and dissolving is added in mold, -40 DEG C of pre-freeze 3h；- 25 DEG C of heat preservations 8h, vacuum degree 300-250mT；- 20 DEG C of heat preservation 6h, vacuum
Spend 250mT；- 5 DEG C of heat preservations 4h, vacuum degree 250-200mT；10 DEG C of heat preservation 3h, vacuum degree 200-100mT, press mold, packaging to get.
A kind of embodiment 2: the freeze-drying of ching-chieh volatile oil molten, mouth preparation
(1) component
(2) preparation method
1) ching-chieh is added to the water of 10 times of medicinal material amounts, 3h is distilled, obtains ching-chieh volatile oil；2) by ching-chieh volatile oil
It is dissolved in dehydrated alcohol, volatile oil/ethanol solution (volume ratio 1:1) is made；3) HP- β-CD saturated aqueous solution, HP- β-CD are prepared
Ratio with volatile oil is 6:1 (g/ml)；4) it will volatilize oily ethanol solution to be added in HP- β-CD saturated aqueous solution, it is permanent
It is stirred at 50 DEG C of temperature, mixing speed 400r/min, the inclusion time is 2h；5) step 4 inclusion compound is cooled to room temperature, 4 DEG C cold
20h is hidden, is filtered, dehydrated alcohol washs 5 times, each dosage 8mL.40 DEG C of vacuum drying for 24 hours, obtain ching-chieh volatile oil beta-CD packet
Close object；6) it by ching-chieh volatile oil beta-CD inclusion, is dissolved with purified water, it is fragrant that mannitol, gelatin, aspartame, orange is added
Smart stirring and dissolving is added in mold, -40 DEG C of pre-freeze 3h；- 25 DEG C of heat preservations 8h, vacuum degree 300-250mT；- 20 DEG C of heat preservation 6h, very
Reciprocal of duty cycle 250mT；- 5 DEG C of heat preservations 4h, vacuum degree 250-200mT；10 DEG C of heat preservation 3h, vacuum degree 200-100mT, press mold, packaging, i.e.,
?.
A kind of embodiment 3: the freeze-drying of ching-chieh volatile oil molten, mouth preparation
(1) component
(2) preparation method
1) ching-chieh is added to the water of 8 times of medicinal material amounts, 2h is distilled, obtains ching-chieh volatile oil；2) by ching-chieh volatile oil
It is dissolved in dehydrated alcohol, volatile oil/ethanol solution (volume ratio 1:1) is made；3) HP- β-CD saturated aqueous solution, HP- β-CD are prepared
Ratio with volatile oil is 6:1 (g/ml)；4) it will volatilize oily ethanol solution to be added in HP- β-CD saturated aqueous solution, it is permanent
It is stirred at 45 DEG C of temperature, mixing speed 400r/min, the inclusion time is 3h；5) step 4 inclusion compound is cooled to room temperature, 4 DEG C cold
18h is hidden, is filtered, dehydrated alcohol washs 4 times, each dosage 10mL.40 DEG C of vacuum drying 36h obtain ching-chieh volatile oil beta-CD packet
Close object；6) it by ching-chieh volatile oil beta-CD inclusion, is dissolved with purified water, lactose, Arabic gum, Sucralose, banana is added
Essence stirring and dissolving is added in mold, -40 DEG C of pre-freeze 3h；- 25 DEG C of heat preservations 8h, vacuum degree 300-250mT；- 20 DEG C of heat preservation 6h,
Vacuum degree 250mT；- 5 DEG C of heat preservations 4h, vacuum degree 250-200mT；10 DEG C of heat preservation 3h, vacuum degree 200-100mT, press mold, packaging,
To obtain the final product.
A kind of embodiment 4: the freeze-drying of ching-chieh volatile oil molten, mouth preparation
(1) component
(2) preparation method
1) ching-chieh is added to the water of 8 times of medicinal material amounts, 2h is distilled, obtains ching-chieh volatile oil；2) by ching-chieh volatile oil
It is dissolved in dehydrated alcohol, volatile oil/ethanol solution (volume ratio 1:1) is made；3) HP- β-CD saturated aqueous solution, HP- β-CD are prepared
Ratio with volatile oil is 6:1 (g/ml)；4) it will volatilize oily ethanol solution to be added in HP- β-CD saturated aqueous solution, it is permanent
It is stirred at 40 DEG C of temperature, mixing speed 400r/min, the inclusion time is 3h；5) step 4 inclusion compound is cooled to room temperature, 4 DEG C cold
18h is hidden, is filtered, dehydrated alcohol washs 5 times, each dosage 5mL.40 DEG C of vacuum drying 30h obtain ching-chieh volatile oil beta-CD packet
Close object；6) by ching-chieh volatile oil beta-CD inclusion, dissolved with purified water, be added mannitol, xanthan gum, macrodex,
Aspartame, lemon extract stirring and dissolving are added in mold, -40 DEG C of pre-freeze 3h；- 25 DEG C of heat preservations 8h, vacuum degree 300-
250mT；- 20 DEG C of heat preservations 6h, vacuum degree 250mT；- 5 DEG C of heat preservations 4h, vacuum degree 250-200mT；10 DEG C of heat preservation 3h, vacuum degree
200-100mT, press mold, packaging to get.
Claims (6)
1. a kind of ching-chieh volatile oil is lyophilized molten, mouth, volume basis, including following component by weight:
2. ching-chieh volatile oil as described in claim 1 is lyophilized molten, mouth, it is characterised in that:
The excipients are 80-100g；The sweetener is 1-2g；The aromatic is 0.5-1g.
3. ching-chieh volatile oil as claimed in claim 1 or 2 is lyophilized molten, mouth, it is characterised in that: 5 excipients are selected from
Gelatin, Arabic gum, xanthan gum, dextran, lactose sorbierite, a kind of either two kinds or more of mixing in mannitol
Object；A kind of sweetener either two kinds or more mixed in Steviosin, Sucralose, aspartame, sucrose, honey
Close object；The aromatic it is a kind of in Hami melon essence, flavoring orange essence, strawberry essence, lemon extract, flavoring banana essence or
It is two kinds or more of mixture.
4. ching-chieh volatile oil as claimed in claim 3 is lyophilized molten, mouth, it is characterised in that: the excipients be gelatin and
The mixture of mannitol；The sweetener is aspartame；The aromatic is flavoring orange essence.
5. molten, mouth preparation method is lyophilized in a kind of ching-chieh volatile oil as described in claim 1, include the following steps:
1) ching-chieh volatile oil is dissolved in dehydrated alcohol, volatile oil ethanol solution is made；The molten volume ratio of volatile oil/dehydrated alcohol
For 1:1；
2) the HP- β-CD amount (g/ml) for weighing 6 times of ching-chieh volatile oil, adds water, dissolves by heating, HP- β-CD saturated water is made
Solution；
3) it will volatilize oily ethanol solution to be added in HP- β-CD saturated aqueous solution, inclusion stirred at 40-50 DEG C of constant temperature, is stirred
Mixing speed is 200-400r/min, and the inclusion time is 2-4h；
4) step 3 inclusion compound is cooled to room temperature, 3 DEG C of -8 DEG C of refrigeration 12h-24h, is filtered, dehydrated alcohol washing 3-5 times, every time
Dosage 5mL-10mL；40 DEG C are dried in vacuo -36h for 24 hours, obtain ching-chieh volatile oil beta-CD inclusion；
5) it by ching-chieh volatile oil HP- beta-CD inclusion, is dissolved with purified water, excipients, sweetener, aromatic stirring is added
Dissolution, be added mold in, freeze-drying, press mold, packaging to get.
6. molten, mouth preparation method is lyophilized in ching-chieh volatile oil as claimed in claim 5, it is characterised in that: the freezing
Drying includes: -40 DEG C of pre-freeze 3h；- 25 DEG C of heat preservations 8h, vacuum degree 300-250mT；- 20 DEG C of heat preservations 6h, vacuum degree 250mT；-5℃
Keep the temperature 4h, vacuum degree 250-200mT；10 DEG C of heat preservations 3h, vacuum degree 200-100mT.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115336744A (en) * | 2022-08-19 | 2022-11-15 | 黑龙江省农业科学院食品加工研究所 | Black fungus leisure food and preparation method thereof |
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| CN104784235A (en) * | 2015-04-28 | 2015-07-22 | 北京同仁堂健康药业（辽宁）有限公司 | Method for preparing fresh ginsengfreeze-dried oral instant preparation |
| CN105769795A (en) * | 2016-04-06 | 2016-07-20 | 合肥华方医药科技有限公司 | Desloratadine citrate disodium freeze-dried oral instant tablets and preparing method thereof |
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| CN103919851A (en) * | 2014-04-29 | 2014-07-16 | 南京海思创新生物科技有限公司 | Preparation method of spica schizonepetae volatile oil clathrate compound, application thereof in preparation of children cold spray and preparation method of spray |
| CN104784235A (en) * | 2015-04-28 | 2015-07-22 | 北京同仁堂健康药业（辽宁）有限公司 | Method for preparing fresh ginsengfreeze-dried oral instant preparation |
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