CN108392473A - A kind of formula and preparation method thereof of the stable freeze-dried preparation containing active oil - Google Patents
A kind of formula and preparation method thereof of the stable freeze-dried preparation containing active oil Download PDFInfo
- Publication number
- CN108392473A CN108392473A CN201710067974.5A CN201710067974A CN108392473A CN 108392473 A CN108392473 A CN 108392473A CN 201710067974 A CN201710067974 A CN 201710067974A CN 108392473 A CN108392473 A CN 108392473A
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- CN
- China
- Prior art keywords
- preparation
- oil
- freeze
- stabilizer
- formula
- Prior art date
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- Pending
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- 238000002360 preparation method Methods 0.000 title claims abstract description 46
- 238000009472 formulation Methods 0.000 title claims abstract description 5
- 239000003381 stabilizer Substances 0.000 claims abstract description 28
- 239000000203 mixture Substances 0.000 claims abstract description 22
- 230000000694 effects Effects 0.000 claims abstract description 19
- 239000003921 oil Substances 0.000 claims description 28
- 235000019198 oils Nutrition 0.000 claims description 28
- -1 ascorbic acid phosphoric acid esters Chemical class 0.000 claims description 17
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 claims description 16
- 239000011230 binding agent Substances 0.000 claims description 15
- 239000003795 chemical substances by application Substances 0.000 claims description 15
- 239000004519 grease Substances 0.000 claims description 12
- 239000000463 material Substances 0.000 claims description 12
- 239000007788 liquid Substances 0.000 claims description 11
- 150000001875 compounds Chemical class 0.000 claims description 10
- 238000004108 freeze drying Methods 0.000 claims description 10
- 239000010802 sludge Substances 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 238000007872 degassing Methods 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 9
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 claims description 8
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 8
- 241000196324 Embryophyta Species 0.000 claims description 8
- BGNXCDMCOKJUMV-UHFFFAOYSA-N Tert-Butylhydroquinone Chemical compound CC(C)(C)C1=CC(O)=CC=C1O BGNXCDMCOKJUMV-UHFFFAOYSA-N 0.000 claims description 8
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- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 7
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- 238000011049 filling Methods 0.000 claims description 6
- 239000002904 solvent Substances 0.000 claims description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 5
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium erythorbate Chemical compound [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims description 5
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims description 4
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- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims description 4
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- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims description 4
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- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 3
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- 229920003086 cellulose ether Polymers 0.000 claims description 3
- 125000003438 dodecyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 claims description 3
- 230000005496 eutectics Effects 0.000 claims description 3
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- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims description 3
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- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 3
- 239000000341 volatile oil Substances 0.000 claims description 3
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims description 3
- GDSOZVZXVXTJMI-SNAWJCMRSA-N (e)-1-methylbut-1-ene-1,2,4-tricarboxylic acid Chemical compound OC(=O)C(/C)=C(C(O)=O)\CCC(O)=O GDSOZVZXVXTJMI-SNAWJCMRSA-N 0.000 claims description 2
- CFWRDBDJAOHXSH-SECBINFHSA-N 2-azaniumylethyl [(2r)-2,3-diacetyloxypropyl] phosphate Chemical compound CC(=O)OC[C@@H](OC(C)=O)COP(O)(=O)OCCN CFWRDBDJAOHXSH-SECBINFHSA-N 0.000 claims description 2
- 108010088751 Albumins Proteins 0.000 claims description 2
- 102000009027 Albumins Human genes 0.000 claims description 2
- 235000017166 Bambusa arundinacea Nutrition 0.000 claims description 2
- 235000017491 Bambusa tulda Nutrition 0.000 claims description 2
- 239000004255 Butylated hydroxyanisole Substances 0.000 claims description 2
- 229920001661 Chitosan Polymers 0.000 claims description 2
- 229920002307 Dextran Polymers 0.000 claims description 2
- GHKOFFNLGXMVNJ-UHFFFAOYSA-N Didodecyl thiobispropanoate Chemical compound CCCCCCCCCCCCOC(=O)CCSCCC(=O)OCCCCCCCCCCCC GHKOFFNLGXMVNJ-UHFFFAOYSA-N 0.000 claims description 2
- 239000003508 Dilauryl thiodipropionate Substances 0.000 claims description 2
- IMQLKJBTEOYOSI-GPIVLXJGSA-N Inositol-hexakisphosphate Chemical compound OP(O)(=O)O[C@H]1[C@H](OP(O)(O)=O)[C@@H](OP(O)(O)=O)[C@H](OP(O)(O)=O)[C@H](OP(O)(O)=O)[C@@H]1OP(O)(O)=O IMQLKJBTEOYOSI-GPIVLXJGSA-N 0.000 claims description 2
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- 244000082204 Phyllostachys viridis Species 0.000 claims description 2
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- IMQLKJBTEOYOSI-UHFFFAOYSA-N Phytic acid Natural products OP(O)(=O)OC1C(OP(O)(O)=O)C(OP(O)(O)=O)C(OP(O)(O)=O)C(OP(O)(O)=O)C1OP(O)(O)=O IMQLKJBTEOYOSI-UHFFFAOYSA-N 0.000 claims description 2
- 229930003427 Vitamin E Natural products 0.000 claims description 2
- RXDLGFMMQFNVLI-UHFFFAOYSA-N [Na].[Na].[Ca] Chemical compound [Na].[Na].[Ca] RXDLGFMMQFNVLI-UHFFFAOYSA-N 0.000 claims description 2
- 150000007513 acids Chemical class 0.000 claims description 2
- SHGAZHPCJJPHSC-YCNIQYBTSA-N all-trans-retinoic acid Chemical compound OC(=O)\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C SHGAZHPCJJPHSC-YCNIQYBTSA-N 0.000 claims description 2
- 239000010775 animal oil Substances 0.000 claims description 2
- 239000012874 anionic emulsifier Substances 0.000 claims description 2
- 239000011425 bamboo Substances 0.000 claims description 2
- 235000019282 butylated hydroxyanisole Nutrition 0.000 claims description 2
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 claims description 2
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- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 2
- 239000002480 mineral oil Substances 0.000 claims description 2
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- 150000003626 triacylglycerols Chemical class 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- LADGBHLMCUINGV-UHFFFAOYSA-N tricaprin Chemical compound CCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCC)COC(=O)CCCCCCCCC LADGBHLMCUINGV-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 229940099259 vaseline Drugs 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/07—Retinol compounds, e.g. vitamin A
-
- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
- A61K31/23—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms
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- 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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/074—Ganoderma
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- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
- A61K8/345—Alcohols containing more than one hydroxy group
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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
- A61K8/347—Phenols
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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/37—Esters of carboxylic acids
- A61K8/375—Esters of carboxylic acids the alcohol moiety containing more than one hydroxy group
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/46—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
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- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
- A61K8/4993—Derivatives containing from 2 to 10 oxyalkylene groups
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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/67—Vitamins
- A61K8/671—Vitamin A; Derivatives thereof, e.g. ester of vitamin A acid, ester of retinol, retinol, retinal
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/67—Vitamins
- A61K8/676—Ascorbic acid, i.e. vitamin C
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- A61K8/00—Cosmetics or similar toiletry preparations
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- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/73—Polysaccharides
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Abstract
The present invention relates to a kind of formulas and preparation method thereof of the stable freeze-dried preparation containing active oil, the formula of especially a kind of activity oil containing efficacy activity, and pass through the formula and preparation method thereof of stable freeze-dried preparation made from certain stabilizer composition and content, it can be adapted for, comprising the formula with efficacy activity and the poor activity oil of stability, obtaining ensureing the product of stability containing active oil and in shelf life.
Description
Technical field
The present invention relates to a kind of formulas and preparation method thereof of the stable freeze-dried preparation containing active oil, and especially one kind contains
The formula of powerful active activity oil, and pass through the formula of stable freeze-dried preparation made from certain stabilizer composition and content
And preparation method thereof, it can be adapted for, comprising the formula with efficacy activity and the poor activity oil of stability, obtaining containing work
Property oil and shelf life ensure stability product.
Background technology
In food, health food, drug, household chemicals, active grease is a kind of common active material, many living
Property grease, such as liposoluble vitamin has very strong physiological activity, and has poor stability simultaneously, especially in liquid
In body preparation system.This kind of active grease can have application range because easily being aoxidized under the conditions of light, air, temperature etc.
Extremely limited, preparation process requires the defects of high, of high cost.
Freeze-drying excipient technology refers to the addition skeleton supporting agent in the active constituent of flowable liquid, semisolid or solid
And itself contains binder and skeleton supporting agent in binder or the flowable liquid, semisolid or solid, then will
It is filled into molding die, and molding technology is able to by freeze drying process, the preparation prepared by the way that excipient technology is lyophilized
Referred to as lyophilized excipient.
Since such preparation uses freeze drying process, labile active ingredient can be protected not to be destroyed, passed through simultaneously
Water sublimed generates a large amount of micropores and duct, can have disintegration and solution rate quickly, therefore receive extensive use, can
To be applied to the multiple fields such as oral disnitegration tablet, fast-release tablet, chewable tablets, special cosmetics, medical instrument, health products.
Inventor dedicates itself to innovation, and has carried out a large amount of in-depth studies and experiment work, based on lyophilized preparation manufacturing process
Principle carries out process optimization, and by the research to formula, provides the formula scheme of a set of addition stabilizer, it is ensured that living
Property oil component ensure that its product is stable and does not improve the production cost of product, work in lyophilized technique and during shelf life
Skill cost.
Invention content
The present invention relates to a kind of formula and preparation method thereof of the stable freeze-dried preparation containing active oil, the lyophilized preparation
Formula is made of active oil, stabilizer and auxiliary material.
The content of the activity oil is 0.001mg/cm than the weight ratio of preparation3-5000mg/cm3, preferably 0.001mg/
cm3-1000mg/cm3, 0.001mg/cm3-500mg/cm3, 0.01mg/cm3-1000mg/cm3, 0.01mg/cm3-500mg/cm3,
Most preferably 0.01mg/cm3-500mg/cm3；Stabiliser content is 0.01mg/cm than the weight ratio of preparation3-5000mg/cm3, excellent
Select 0.001mg/cm3-1000mg/cm3, 0.001mg/cm3-500mg/cm3, 0.01mg/cm3-1000mg/cm3, 0.01mg/
cm3-500mg/cm3, 0.05mg/cm3-500mg/cm3, most preferably 0.01mg/cm3-500mg/cm3。
The activity oil is the grease-like composition with certain efficacy activity, can be selected from animal oil, vegetable oil, manually close
At one or more combinations in grease and mineral oil；It is preferred that liposoluble vitamin and its reactive derivative, caprylic/capric glycerine
One or more combinations of lipid, animals and plants active grease extract；Most preferably retinol, retinoic acid, tocopherol, tocopherol spread out
One or more combinations in biology, active botanical essential oils.
The stabilizer can be folk prescription stabilizer or compound stabilizer；Its ingredient can be selected from 2,6- di-t-butyls to first
Phenol, tert-butylhydroquinone, butylated hydroxy anisole, thio-2 acid double lauryl, thio-2 acid, thio-2 acids two
Lauryl, propylgallate, pentaerythrite four (double-tert-butyl hydroxyhydrocinnamic acid) ester, ascorbic acid, D- are different anti-bad
Hematic acid, sodium isoascorbate, sodium ascorbate, Calcium Ascorbate, ascorbyl palmitate, ascorbic acid phosphoric acid esters, dimension life
Plain E, vitamin e derivative, lecithin, cephalin, Licorice root antioxidant, 4- hexyl resorcins, Rosmarinus officinalis extract, the leaf of bamboo
One or more combinations in polyphenoils, calcium disodium chelate, Oxystearin, tea polyphenols, phytic acid；Wherein compound
Stabilizer preferably 2,6- toluene di-tert-butyl phenols are combined with the compound of other stabilizers or tert-butylhydroquinone is steady with other
Determine the compound combination or 2 of agent, 6- toluene di-tert-butyl phenols and tert-butylhydroquinone are combined with the compound of other stabilizers.
The auxiliary material, is made of emulsifier and binder.
The emulsifier, it is a kind of or more selected from anionic emulsifier, cationic emulsifier and nonionic emulsifier
Kind combination.
The binder can be freeze-drying binder or the combination of binder and low temperature bonding agent is lyophilized.
The freeze-drying binder is artificial or natural polymers, inorganic matter gelling agent, cellulose ethers, modified shallow lake
Powder class, hyalomitome acids, albumin, dextran, chitosan and its different molecular weight product, PVP, PVA, gather sodium alginate
Ethylene glycol, agar, polyaminoacid, glycan or combination thereof；The alcohol, grease, surface that the low temperature bonding agent is C1-C16 are lived
One or more combinations in property agent, high molecular polymer.
The alcohol of the C1-C6 be selected from propylene glycol, butanediol, glycerine, 1,2 butanediols, 1,2 propylene glycol, 1,3 butanediols,
It is one or more in pentanediol, polyethylene glycol, polyglycereol, diglycerol etc..
The grease is selected from dimethyl silicone polymer, eight stearate of polyglycereol -6, caprylic/capric triglyceride, glycerine
Three (thylhexoic acid) esters, diisooctadecanol malate, three isostearate of polyglycereol -2, dipentaerythritol three-poly- hydroxyl
Stearate, phytosterols oletate, vaseline, xanthans, glycerine three (behenic acid/isostearic acid/eicosane diacid) ester, lecithin
Fat, hydrolecithin, Nexbase 2004, ethylhexyl methoxy cinnamate, cream, ermine oil, goose oil, dogfish oil, almond oil,
Apricot kernel oil, olive oil, sesame oil, tea-seed oil, ethylhexyl palmitate, Butyrospermum parkii fruit ester, lauric acid hexyl ester, carbonic acid two are pungent
It is one or more in ester, GTCC, sad Propylheptyl, oleyl alcohol or triglycerides etc..
The surfactant is selected from tween constituents, sapn constituents, PEG-20 glyceryl triisostearates, poly- sweet
It is one or more in oily -10 distearates, -2 oleate of polyglycereol, cocounut oil acyl glycine potassium, lauroyl glycine potassium etc..
The high molecular polymer be sodium alginate, lanolin, agar, polyvinyl alcohol methyl acrylate graft copolymer,
Carbomer, carbomer, Sodium Hyaluronate, hyaluronic acid, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyoxyethylene
One kind in alkene, modified paraffin, polyacrylamide, Sodium Polyacrylate, polyacrylate and polyacrylic acid and its derivative etc. or
It is a variety of.
The inorganic matter gelling agent is diatomite, bentonite, montmorillonite, Li-montmorillonite, one kind in Silica hydrogel or more
Kind.
The glue class binder is collagen, gelatin, gelatin hydrolysate, Arabic gum, xanthans, soybean protein glue, pyrenomycetes
Glue, biological carbohydrate gum, carragheen, guar gum, gellan gum, pectin, konjac glucomannan, carrageenan, locust bean gum, natural gum, locust bean gum etc.
In it is one or more.
The cellulose ethers binder is microcrystalline cellulose, carboxymethyl cellulose, carboxyethyl cellulose, ethoxy first
It is one or more in base cellulose, hydroxypropyl methyl cellulose etc..
The modified starch series binder is selected from Sodium Polyacrylate graft starch, pulullan, hydroxypropul starch, hydroxypropyl
One kind or more in methyl starch, pregelatinized starch, amylose, carboxymethyl starch, hydroxyethyl starch, hydroxypropul starch etc.
Kind.
The one kind or more of the polyaminoacid in polyglutamic acid, polyalanine, poly-aspartate, polylysine etc.
Kind.
The glycan is one or more in fucoidin, synanthrin, glucan etc..
The formula can also further add other auxiliary materials in formula, be selected from skeleton supporting agent, skin sense modifying agent,
Antioxidant, corrigent, essence, across one or more combinations in mucous membrane, skin penetration enhancer and pH adjusting agent.
The skeleton agent is selected from sugared (such as maltose, trehalose), sugar alcohol (such as mannitol, sorbierite), 2-12 carbon atoms
Amino acid (such as glycine, alanine, glutamic acid) and any one of inorganic salts (such as sodium phosphate, alumina silicate) or number
Kind mixture.
The skin sense modifying agent is selected from polymethylsilsesquioxane, tapioca, two C12-13 alcohol malates, two Pork and beans
Cool alcohol tartrate, PPG-15 tristearin alcohol ether, polyamide fibre -12, wineberry seed oil etc. have any in the substance for improving skin sense
Kind or several mixtures.
The antioxidant is selected from vitamin C, vitamin E, anthocyanidin, resveratrol, glutathione, superoxides discrimination
Change enzyme, saccharomycete/rice fermentation Product filtrate, plant extracts, Beauveria sp extract, kahikatea dew fungus extract, fruits and vegetables extraction
Object, plant origin polyhydric phenols etc. there is any one of anti-oxidation efficacy substance or several mixtures.
The corrigent and essence be selected from mint flavored, chocolate flavoured, fruits and vegetables taste, flowers and plants fragrance, plant flavour, vanilla flavored,
The mixture of essence or the one of the above such as caf, tea flavour, corn taste, lemon, milk flavor or several fragrance.
It is described to be selected from any one of lecithin, tween, sapn or several mixed across mucous membrane or skin penetration enhancer
Close object.
The PH conditioning agents are selected from citric acid, sorbic acid, tartaric acid, lactic acid, malic acid, sodium bicarbonate, sodium carbonate, phosphorus
Any one of sour disodium hydrogen, calcium phosphate, potassium phosphate, tricresyl phosphate magnesium etc. or several mixtures.
The invention further relates to the preparation methods of above-mentioned formula, have following preparation method：
A, method 1
A) solution, lotion or the suspension for forming water, active oil, stabilizer, auxiliary material, constant volume, degassing；
B) quantitative filling pump is used, will a) be injected into quantitative molding die, be de-gassed；
C) it will b) be freeze-dried, remove solvent, obtain the stable freeze-dried preparation for including activity oil and stabilizer, and system is lyophilized
Dress can be wrapped inside with break away from moulds in agent.
B, method 2
A) sludge ice mixture is prepared：
By active oil, stabilizer and auxiliary material, is completely or partially mixed with solvent, congeal, obtain sludge ice mixture 1；
B) 1) all sludge ice mixtures obtained are used into certain mould shape, the mixture 2 after being shaped, demoulding；
C) mixture 2 is freeze-dried, obtains lyophilized preparation.
C, method 3
A) solution, lotion or the suspension for forming water, activity oil, stabilizer and auxiliary material, constant volume, degassing；
B) quantitative filling pump is used, is in solution eutectic point nacelle below and instils in internal temperature, make its drop
Freeze rapidly when liquid；
C) frozen solution is freeze-dried, obtains the stable freeze-dried preparation for including activity oil and stabilizer.
The present invention also includes above-mentioned any one formula and/or the product that preparation method is prepared.
The product is arbitrary shape.Can be figure of tablet, capsule shape, soft capsule shape, spherical shape, elliposoidal or
The various personages of person, animal, plant, food, pattern identification or cartoon character.
Specific implementation mode
It further illustrates the present invention by the following examples, but the present invention is not restricted to this.
Embodiment 1
By retinol 0.5g, polysorbas20 0.5g, Tween 80 2g, glucan 0.75g, 2,6- toluene di-tert-butyl phenols
0.25g, Propiram 7g, mannitol 12.5g are dissolved in 250ml water, and constant volume, degassing obtain mixed solution, using liquid-transfering gun,
Mixed solution is fed into piece shape mold, after degassing, pre-freeze, freeze-drying, removing solvent, obtains stable external application retinol
Lyophilized preparation.
Embodiment 2
By retinol 1g, polysorbas20 1g, Tween 80 4g, glucan 0.75g, 2,6- toluene di-tert-butyl phenol 0.25g,
Tert-butylhydroquinone 0.15g, Propiram 7g, mannitol 12.5g are dissolved in 250ml water, and constant volume, degassing obtain mixing molten
Liquid is in solution eutectic point nacelle below in internal temperature and is instiled using peristaltic pump, makes to freeze rapidly when its dropping liquid
Knot, frozen solution is freeze-dried, stable external application retinol lyophilized preparation is obtained.
Embodiment 3
By retinol 1g, Tween 80 1g, Tween 80 4g, 2,6- toluene di-tert-butyl phenol 0.58g, tertiary butyl is to benzene two
Phenol 0.35g, glycerine 29g, melon bean gum 1.7g, Propiram 2.9g is added in 58ml water and is uniformly dissolved into mixed solution, by liquid
It congeals under the conditions of -7 DEG C, forms sludge ice mixture；Sludge ice mixture is packed into the ball-type for passing through precooling using quantitative filling pump
Mold is quantitative；Using liquid nitrogen circulation temperature lowering mode, make quantitative component break away from moulds under -205 DEG C of environment；It will be disengaged from the group of mold
Divide and be lyophilized, obtains stable external application retinol lyophilized preparation.
Embodiment 4
By caprylic/capric glyceride 8%, mannitol 5%, Sodium Hyaluronate 0.2%, Tween 80 8%, 2, bis- tertiary fourths of 6-
Base p-cresol 0.1%, dilauryl thiodipropionate 0.25% are dissolved in 1L water, and constant volume, degassing obtain mixed solution,
Using liquid-transfering gun, mixed solution is fed into hemispherical, after degassing, pre-freeze, freeze-drying, removing solvent, is obtained steady
Fixed external application active grease lyophilized preparation.
Embodiment 5
By oiliness Ganodenna Lucidum P.E 10%, tert-butylhydroquinone 0.06%, sodium ascorbate 0.1%, mannitol 15%,
Sodium Hyaluronate 0.5%, Tween 80 5%, glycerine 2% are dissolved in 1L water uniformly at mixed solution, by liquid in -10 DEG C of items
It congeals under part, forms sludge ice mixture；Sludge ice mixture is quantified using the spherical module that quantitative filling pump is packed by precooling；
Using liquid nitrogen circulation temperature lowering mode, make quantitative component break away from moulds under -200 DEG C of environment；The component that will be disengaged from mold is frozen
It is dry, obtain stable exterior-applied plant essential oil lyophilized preparation.
It is according to the present invention at be grouped as, form and preparation method are not limited to form cited in embodiment, real
It is only presently preferred embodiments of the present invention to apply example, cannot limit protection domain with this.It is all with scope of the presently claimed invention
The simple or equivalent variation and modification, comes under protection scope of the present invention.
Claims (12)
1. a kind of formula and preparation method thereof of the stable freeze-dried preparation containing active oil, which is characterized in that the lyophilized preparation
Formula is made of active oil, stabilizer and auxiliary material；Wherein the content of activity oil is 0.001mg/cm than the weight ratio of preparation3-
5000mg/cm3, stabiliser content is 0.01mg/cm than the weight ratio of preparation3-5000mg/cm3。
2. formula according to claim 1, which is characterized in that the activity oil is the grease type with certain efficacy activity
Ingredient, can be selected from one or more combinations in animal oil, vegetable oil, artificial synthesized grease and mineral oil；It is preferred that fat-soluble
One or more combinations of vitamin and its reactive derivative, caprylic/capric glycerolipid, animals and plants active grease extract；
One or more combinations most preferably in retinol, retinoic acid, tocopherol, Tocopheryl derivatives, active botanical essential oils.
3. according to the formula described in claim 1,2, which is characterized in that the stabilizer can be that folk prescription stabilizer or compound are steady
Determine agent；Its ingredient can be selected from 2,6- toluene di-tert-butyl phenols, tert-butylhydroquinone, butylated hydroxy anisole, thio two
Propionic acid double lauryl, thio-2 acid, dilauryl thiodipropionate, propylgallate, the (double-tert-butyls of pentaerythrite four
Hydroxyhydrocinnamic acid) it is ester, ascorbic acid, D-araboascorbic acid, sodium isoascorbate, sodium ascorbate, Calcium Ascorbate, anti-
Bad hematic acid palmitate, ascorbic acid phosphoric acid esters, vitamin E, vitamin e derivative, lecithin, cephalin, Radix Glycyrrhizae are anti-oxidant
Object, 4- hexyl resorcins, Rosmarinus officinalis extract, bamboo leaf antioxidant, calcium disodium chelate, Oxystearin, tea
One or more combinations in polyphenol, phytic acid；The wherein preferred 2,6- toluene di-tert-butyl phenols of compound stabilizer and other stabilizations
The compound of agent combines or tert-butylhydroquinone is combined with the compound of other stabilizers or 2,6- toluene di-tert-butyl phenols with
Tert-butylhydroquinone is combined with the compound of other stabilizers.
4. according to the formula described in claim 1-3, which is characterized in that the auxiliary material is made of emulsifier and binder.
5. according to the formula described in claim 1-4, which is characterized in that the emulsifier, selected from anionic emulsifier, sun from
Subtype emulsifier and the one or more combinations of nonionic emulsifier.
6. according to the formula described in claim 1-5, which is characterized in that the binder can be freeze-drying binder or freeze-drying
The combination of binder and low temperature bonding agent.
7. according to the formula described in claim 1-6, which is characterized in that the freeze-drying binder is that artificial or natural polymer is poly-
Close object, inorganic matter gelling agent, cellulose ethers, modified starch series, hyalomitome acids, albumin, dextran, chitosan and its
Different molecular weight product, sodium alginate, PVP, PVA, polyethylene glycol, agar, polyaminoacid, glycan or combination thereof；It is described
Low temperature bonding agent is one or more combinations in the alcohol of C1-C16, grease, surfactant, high molecular polymer.
8. according to the formula described in claim 1-7, which is characterized in that other auxiliary materials can also be further added in formula,
Selected from skeleton supporting agent, skin sense modifying agent, antioxidant, corrigent, essence, across mucous membrane, skin penetration enhancer and pH adjusting
One or more combinations in agent.
9. preparation method according to claim 1, which is characterized in that have following preparation method：
A, method 1
A) solution, lotion or the suspension for forming water, active oil, stabilizer, auxiliary material, constant volume, degassing；
B) quantitative filling pump is used, will a) be injected into quantitative molding die, be de-gassed；
C) it will b) be freeze-dried, remove solvent, obtain the stable freeze-dried preparation for including activity oil and stabilizer, and lyophilized preparation can
With break away from moulds, dress is wrapped inside.
B, method 2
A) sludge ice mixture is prepared：
By active oil, stabilizer and auxiliary material, is completely or partially mixed with solvent, congeal, obtain sludge ice mixture 1；
B) 1) all sludge ice mixtures obtained are used into certain mould shape, the mixture 2 after being shaped, demoulding；
C) mixture 2 is freeze-dried, obtains lyophilized preparation.
C, method 3
A) solution, lotion or the suspension for forming water, activity oil, stabilizer and auxiliary material, constant volume, degassing；
B) quantitative filling pump is used, is in solution eutectic point nacelle below and instils in internal temperature, when making its dropping liquid
Freeze rapidly；
C) frozen solution is freeze-dried, obtains the stable freeze-dried preparation for including activity oil and stabilizer.
10. the product being prepared by any one of claim 1-9 formulas and/or preparation method.
11. product according to claim 10, which is characterized in that it is arbitrary shape.
12. product according to claim 11, which is characterized in that it is figure of tablet, capsule shape, flexible glue scrotiform
Shape, spherical shape, elliposoidal or various personages, animal, plant, food, pattern identification or cartoon character.
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| JP2019514947A (en) * | 2016-05-12 | 2019-06-06 | ユニリーバー・ナームローゼ・ベンノートシヤープ | Method for Stabilizing Retinoic Acid Precursor and Skin Benefit Composition Comprising Stabilized Retinoic Acid Precursor |
| CN110393703A (en) * | 2018-04-25 | 2019-11-01 | 山东坦途农业科技有限公司 | A kind of lyophilized excipient of ascorbic acid and preparation method thereof |
| CN110592056A (en) * | 2019-09-19 | 2019-12-20 | 昆明理工大学 | Phage lyase composite powder and preparation method and application thereof |
| CN114599337A (en) * | 2019-10-25 | 2022-06-07 | 联合利华知识产权控股有限公司 | Cosmetic compositions with enhanced color stability |
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| JP2019514947A (en) * | 2016-05-12 | 2019-06-06 | ユニリーバー・ナームローゼ・ベンノートシヤープ | Method for Stabilizing Retinoic Acid Precursor and Skin Benefit Composition Comprising Stabilized Retinoic Acid Precursor |
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| CN110592056A (en) * | 2019-09-19 | 2019-12-20 | 昆明理工大学 | Phage lyase composite powder and preparation method and application thereof |
| CN114599337A (en) * | 2019-10-25 | 2022-06-07 | 联合利华知识产权控股有限公司 | Cosmetic compositions with enhanced color stability |
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| CN108392473A8 (en) | 2018-09-07 |
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| CI02 | Correction of invention patent application |
Correction item: Applicant|Address Correct: Dong Ling|100024 School of life sciences, Beijing University of Chinese Medicine, Fangshan District, Beijing False: CHANGZHOU YOUDUN INDUSTRIAL INVESTMENT CO.,LTD.|No. 9, river Hai Dong Road, Tianning District, Changzhou, Jiangsu Number: 33-01 Page: The title page Volume: 34 Correction item: Applicant|Address Correct: Dong Ling|100024 School of life sciences, Beijing University of Chinese Medicine, Fangshan District, Beijing False: CHANGZHOU YOUDUN INDUSTRIAL INVESTMENT CO.,LTD.|No. 9, river Hai Dong Road, Tianning District, Changzhou, Jiangsu Number: 33-01 Volume: 34 |
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