CN114903809A - Single-matrix freeze-dried excipient, preparation method thereof and freeze-dried preparation for beautifying and protecting skin - Google Patents
Single-matrix freeze-dried excipient, preparation method thereof and freeze-dried preparation for beautifying and protecting skin Download PDFInfo
- Publication number
- CN114903809A CN114903809A CN202110172581.7A CN202110172581A CN114903809A CN 114903809 A CN114903809 A CN 114903809A CN 202110172581 A CN202110172581 A CN 202110172581A CN 114903809 A CN114903809 A CN 114903809A
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- CN
- China
- Prior art keywords
- single matrix
- freeze
- dried
- silk fibroin
- excipient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- 239000011159 matrix material Substances 0.000 title claims abstract description 86
- 239000000546 pharmaceutical excipient Substances 0.000 title claims abstract description 46
- 238000002360 preparation method Methods 0.000 title claims abstract description 32
- 108010022355 Fibroins Proteins 0.000 claims abstract description 43
- 239000007788 liquid Substances 0.000 claims abstract description 35
- 239000003814 drug Substances 0.000 claims abstract description 27
- 229940079593 drug Drugs 0.000 claims abstract description 25
- 239000007864 aqueous solution Substances 0.000 claims abstract description 7
- 230000003796 beauty Effects 0.000 claims abstract description 7
- 239000002994 raw material Substances 0.000 claims abstract description 6
- 239000000243 solution Substances 0.000 claims description 34
- 239000000203 mixture Substances 0.000 claims description 22
- 239000004480 active ingredient Substances 0.000 claims description 16
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- 239000002243 precursor Substances 0.000 claims description 14
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- 238000009472 formulation Methods 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 8
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 238000004108 freeze drying Methods 0.000 claims description 7
- 238000007872 degassing Methods 0.000 claims description 6
- 238000002156 mixing Methods 0.000 claims description 6
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- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerol Natural products OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 4
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- RWSXRVCMGQZWBV-WDSKDSINSA-N glutathione Chemical compound OC(=O)[C@@H](N)CCC(=O)N[C@@H](CS)C(=O)NCC(O)=O RWSXRVCMGQZWBV-WDSKDSINSA-N 0.000 claims description 4
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- 238000007710 freezing Methods 0.000 claims description 3
- 230000008014 freezing Effects 0.000 claims description 3
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- A61K8/67—Vitamins
- A61K8/676—Ascorbic acid, i.e. vitamin C
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- A—HUMAN NECESSITIES
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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
- A61K8/678—Tocopherol, i.e. vitamin E
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
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- A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
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- A61K8/00—Cosmetics or similar toiletry preparations
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- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
- A61K8/9728—Fungi, e.g. yeasts
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
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- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
- A61K8/9783—Angiosperms [Magnoliophyta]
- A61K8/9789—Magnoliopsida [dicotyledons]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
- A61K8/9783—Angiosperms [Magnoliophyta]
- A61K8/9794—Liliopsida [monocotyledons]
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/10—General cosmetic use
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
- A61K2800/84—Products or compounds obtained by lyophilisation, freeze-drying
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Abstract
The invention discloses a single-matrix freeze-dried excipient, a preparation method thereof and a freeze-dried preparation for beautifying and protecting skin. The raw materials of the single matrix freeze-dried excipient comprise a single matrix liquid and a main drug, wherein the single matrix liquid is a silk fibroin aqueous solution. The freeze-dried excipient with single matrix does not contain a framework support agent and only contains the silk fibroin single matrix, so that the content of main drugs in the freeze-dried excipient is improved to the maximum extent. Meanwhile, the good biocompatibility of the silk fibroin also improves the main drug efficacy of the freeze-dried excipient, and when the freeze-dried excipient is applied to a beauty skin-care freeze-dried preparation, the re-dissolving speed is high, the skin feel is good, and the freeze-dried excipient is smooth and non-sticky. In addition, the silk fibroin has the functions of penetration promotion and whitening, and has good application prospect in the field of beauty and skin care.
Description
Technical Field
The invention relates to the technical field of freeze-dried preparations, in particular to a single-matrix freeze-dried excipient, a preparation method thereof and a beauty and skin care freeze-dried preparation.
Background
The freeze-dried excipient is prepared by preparing the main drug into solution or emulsion, freeze-drying the main drug by a freeze-drying method, and adding water for redissolution before use. The freeze-dried excipient contains functional components which are freeze-dried and sealed for storage, so that the damage of oxidation and hydrolysis is isolated, the main medicine efficacy of the components can be furthest stored, the defects of the traditional dosage form are avoided, and the freeze-dried excipient has obvious functional advantages.
The traditional freeze-dried excipient consists of a matrix and an active ingredient, wherein the matrix comprises a skeleton supporting agent and a binder, and the skeleton supporting agent is mostly selected from sugar, sugar alcohol, amino acid with 2-12 carbon atoms, inorganic salt (such as sodium phosphate, aluminum silicate and the like) and the like. Since sugars, sugar alcohols, and inorganic salts (e.g., sodium phosphate, aluminum silicate, etc.) have hygroscopicity, they easily absorb moisture in the air during the production process to cause collapse or complete collapse of the skeleton structural components of the lyophilized excipient, or cause adhesion to the hands due to rapid moisture absorption when the user opens the package, etc., which may adversely affect the feeling of use, and the skeleton-supporting agent also has many disadvantages such as prolonging the disintegration process.
The Chinese invention patent (grant publication number: CN 103893770B) discloses a freeze-dried excipient and a preparation method thereof. In the patent of the invention, the freeze-dried excipient only consists of an active ingredient and a binder, wherein the active ingredient is selected from selegiline, and the binder is selected from polyglutamic acid. The invention can achieve the technical effects of reducing moisture absorption risk, simplifying preparation process, reducing cost and improving unit drug-loading rate by avoiding using a skeleton supporting agent.
The silk fibroin is natural polymer fibrin extracted from silk, the content of the natural polymer fibrin accounts for about 70-80% of the silk, and the silk fibroin contains 18 amino acids, wherein glycine (Gly), alanine (Ala) and serine (Ser) account for more than 80% of the total composition. The silk fibroin has good mechanical properties and physicochemical properties, such as good flexibility, tensile strength, air permeability, moisture permeability, slow release property and the like. In addition, the silk fibroin also has the function of penetration promotion, has the whitening effect and has good application prospect in beauty and skin care products.
Disclosure of Invention
The invention aims to provide a single-matrix freeze-dried excipient which comprises raw materials of a single matrix solution and a main drug, wherein the single matrix solution is a silk fibroin aqueous solution. The freeze-dried excipient with single matrix does not contain a framework support agent and only contains the silk fibroin single matrix, so that the content of main drugs in the freeze-dried excipient is improved to the maximum extent. Meanwhile, the good biocompatibility of the silk fibroin also improves the main drug efficacy of the freeze-dried excipient.
The invention also aims to provide a preparation method of the single-matrix freeze-dried excipient, wherein the concentration range of the silk fibroin in a single matrix liquid is wide, so that the preparation method is suitable for different formula systems.
The invention also aims to provide the application of the single-matrix freeze-dried excipient in the cosmetic skincare product.
The invention also aims to provide a freeze-dried preparation for beautifying and protecting skin.
The invention also aims to provide application of the freeze-dried cosmetic skin care preparation in the field of cosmetic skin care.
The technical scheme adopted for realizing the purpose of the invention is as follows:
a single matrix lyophilized excipient comprises a single matrix solution and a main drug; the single matrix solution is silk fibroin aqueous solution.
In the above technical scheme, the concentration of the silk fibroin in the single matrix solution is 0.0001% -75%.
In the technical scheme, the concentration of the silk fibroin in the single matrix solution is 0.0001% -1%; the mass of solid in the main drug accounts for 0.0001-25% of the total mass of the single matrix liquid. The solid matter is solid matter.
In the technical scheme, the concentration of the silk fibroin in the single matrix solution is 1% -30%; the mass of solid in the main drug accounts for 0.0001-60% of the total mass of the single matrix liquid.
In the technical scheme, the concentration of the silk fibroin in the single matrix solution is 30% -75%; the mass of solid matters in the main drug accounts for 0.0001-25% of the total mass of the single matrix liquid; the mass of the aqueous liquid in the main drug accounts for 25-70% of the total mass of the single matrix liquid.
In the technical scheme, the main drug can be selected from skin care active ingredients, and also can be selected from one or a mixture of other chemical drugs and traditional Chinese medicine extracts in any proportion.
In another aspect of the present invention, a method for preparing a single matrix lyophilized excipient comprises the following steps:
step 1: preparation of a Freeze-dried precursor solution
Mixing and dissolving silk fibroin and water to obtain a single matrix solution, adding a main drug into the single matrix solution, and uniformly mixing to obtain a freeze-dried precursor solution;
step 2: subpackaging the freeze-dried precursor liquid obtained in the step 1 into a quantitative forming mold, and performing degassing treatment;
and 3, step 3: and (3) quickly freezing the degassed freeze-dried precursor solution in a quantitative forming mould, then freeze-drying, and demoulding to obtain the freeze-dried excipient.
In the technical scheme, the viscosity of the single matrix liquid is 5cps-5000 cps.
In the technical scheme, the friability of the obtained freeze-dried excipient is less than 0.1%; the obtained lyophilized excipient has disintegration rate of 1-15 s.
In another aspect of the present invention, the single matrix lyophilized excipient is used for skin care.
In another aspect of the invention, a freeze-dried preparation for beauty and skin care comprises raw materials including a single matrix liquid and a skin care active ingredient; the single matrix solution is silk fibroin aqueous solution.
In the above technical scheme, the concentration of the silk fibroin in the single matrix solution is 0.0001% -75%.
In the technical scheme, the concentration of the silk fibroin in the single matrix solution is 0.0001% -1%; the mass of the skin care active component accounts for 0.0001-25% of the total mass of the single matrix liquid; the skin care active ingredients comprise peptides and plant extracts; the peptides comprise one or a mixture of glutathione, tripeptide-1, acetyl hexapeptide-8, nonapeptide-1, acetyl tetrapeptide-2, carnosine and copper peptide in any proportion; the plant extract comprises one or a mixture of any proportion of centella asiatica extract, angelica root extract, mastic resin extract, cucumber fruit extract, lavender extract, rose extract, ginger root extract, ganoderma lucidum extract and oat extract.
In the technical scheme, the concentration of the silk fibroin in the single matrix solution is 1% -30%; the mass of the active ingredients accounts for 0.0001-60% of the total mass of the single matrix liquid; the active ingredients comprise one or a mixture of squalane, argan, jojoba oil, fullerene, cannabidiol, coenzyme Q10, SOD, VA and derivatives, VE and derivatives, VB3, biotin, pantothenic acid and derivatives, VC and derivatives, saponin and flavone in any proportion.
In the technical scheme, the concentration of the silk fibroin in the single matrix solution is 30% -75%; the mass of the active ingredients accounts for 0.0001-25% of the total mass of the single matrix liquid; the active ingredients comprise one or a mixture of tetrahydropyrane triol, glycerol glucoside, baicalin and ferulic acid in any proportion.
In the technical scheme, the beverage also comprises auxiliary components, wherein the auxiliary components comprise one or more of an emulsifier, a humectant, a pigment and essence; the emulsifier comprises one or a mixture of poloxamer, polyglycerol ester and tween at any ratio.
In another aspect of the invention, the freeze-dried cosmetic skin care preparation is applied to the field of cosmetic skin care.
Compared with the prior art, the invention has the beneficial effects that:
1. the raw materials of the single-matrix freeze-dried excipient provided by the invention comprise a single matrix solution and a main drug, wherein the single matrix solution is a silk fibroin aqueous solution. The freeze-dried excipient with single matrix does not contain a framework support agent and only contains the silk fibroin single matrix, so that the content of main drugs in the freeze-dried excipient is improved to the maximum extent.
2. In the preparation method of the single-matrix freeze-dried excipient provided by the invention, the concentration range of the fibroin in the single matrix liquid is wide and is 0.0001-75%, and the viscosity of the single matrix liquid in the range is 5-5000cps, so that the freeze-dried excipient can meet the requirements. The addition range of the traditional binder is 0.5-3.0%, and if the addition range exceeds the range, the traditional binder cannot be molded or disintegrated, so that the requirement of freeze-drying forming cannot be met. The concentration range of the silk fibroin is wide, the silk fibroin can be better suitable for different formula systems, and simultaneously the silk fibroin can be molded without influencing the disintegration speed, so the silk fibroin has great application prospect in the field of freeze-drying excipient.
3. The freeze-dried preparation for beautifying and protecting skin provided by the invention has the advantages of high redissolution speed, good skin feel and smoothness without stickiness. In addition, the silk fibroin has the functions of penetration promotion and whitening, and has good application prospect in the field of beauty and skin care.
Detailed Description
The present invention will be described in further detail with reference to specific examples. It should be understood that the specific embodiments described herein are merely illustrative of the invention and do not limit the invention.
Example 1
A preparation method of a single-matrix freeze-dried excipient comprises the following steps:
step 1: preparation of a Freeze-dried precursor solution
Mixing and dissolving silk fibroin and water to obtain single matrix solution, adding a main drug into the single matrix solution, and uniformly mixing to obtain freeze-dried precursor solution;
step 2: subpackaging the freeze-dried precursor liquid obtained in the step 1 into a quantitative forming mold, and performing degassing treatment, wherein the degassing method can adopt a centrifugal degassing method, a vacuum degassing method or an ultrasonic degassing method;
and step 3: and (3) quickly freezing the degassed freeze-dried precursor liquid in a quantitative forming die by liquid nitrogen, transferring the freeze-dried precursor liquid into a freeze dryer, freeze-drying the freeze-dried precursor liquid at the temperature of-30 ℃ under the pressure of 0.5mPa, and demoulding to obtain the freeze-dried excipient.
Example 2
A series of single matrix lyophilized vehicle formulations (1-4) and cosmetic skin care lyophilized formulations (5-11) were prepared according to the following formulation using the preparation method of example 1.
In the above table, the content (%) means the ratio of the mass of each substance to the mass of a single base liquid.
The disintegration rate is the time for which the formulation is put into a test tube containing 2 ml of water at 37 ℃, and the formulation is observed to completely disintegrate and pass through a 20-mesh sieve.
The friability means that the preparation is dropped onto a stainless steel platform from a position with the height of one meter in a free falling mode, 100 granules are thrown, and the total falling powder is determined to be qualified, wherein the weight of the total falling powder is less than 3 percent of the total weight of the preparation.
Example 3
The freeze-dried preparation (5-11) for beautifying and protecting skin obtained in the example 2 is added with water for re-dissolving when in use, and the viscosity of the skin-care liquid obtained after re-dissolving is 5-5000 cps.
The measuring method comprises the following steps: adding 0.15-0.5ml of lyophilized preparation for skin care into water for redissolving to obtain skin care liquid, wherein the water addition amount is 0.5ml per single dose.
According to the skin sensation test method, 20 test volunteers are randomly selected from each sample, and the skin sensation types selected by more than 75% of the volunteers are the skin sensation test results of the sample.
The single matrix lyophilized vehicle of the present invention was prepared according to the present disclosure with process parameter adjustments and exhibited substantially the same performance as examples 2 and 3.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, many modifications and adaptations can be made without departing from the principle of the present invention, and such modifications and adaptations should also be considered as the scope of the present invention.
Claims (16)
1. A single matrix freeze-dried excipient is characterized in that raw materials comprise a single matrix solution and a main drug; the single matrix solution is silk fibroin aqueous solution.
2. The single matrix lyophilized excipient of claim 1 wherein the concentration of fibroin in said single matrix fluid is 0.0001% to 75%.
3. The single matrix lyophilized excipient of claim 2 wherein the concentration of the silk fibroin in the single matrix fluid is between 0.0001% and 1%; the mass of solid matters in the main drug accounts for 0.0001-25% of the total mass of the single matrix liquid.
4. The single matrix lyophilized excipient of claim 2 wherein the concentration of the silk fibroin in the single matrix fluid is 1% to 30%; the mass of solid in the main drug accounts for 0.0001-60% of the total mass of the single matrix liquid.
5. The single matrix lyophilized vehicle of claim 2, wherein the concentration of the silk fibroin in the single matrix solution is 30% -75%; the mass of solid in the main drug accounts for 0.0001-25% of the total mass of the single matrix liquid; the mass of the aqueous liquid in the main drug accounts for 25-70% of the total mass of the single matrix liquid.
6. A preparation method of a single-matrix freeze-dried excipient is characterized by comprising the following steps:
step 1: preparation of a Freeze-dried precursor solution
Mixing and dissolving silk fibroin and water to obtain single matrix solution, adding a main drug into the single matrix solution, and uniformly mixing to obtain freeze-dried precursor solution;
and 2, step: subpackaging the freeze-dried precursor liquid obtained in the step 1 into a quantitative forming die, and performing degassing treatment;
and step 3: and (3) quickly freezing the degassed freeze-dried precursor solution in a quantitative forming mould, then freeze-drying, and demoulding to obtain the freeze-dried excipient.
7. The method of claim 6, wherein: the viscosity of the single matrix liquid is 5cps-5000 cps.
8. The process according to claim 6, wherein the friability of the resulting lyophilized excipient preparation is less than 0.1%; the obtained lyophilized excipient has disintegration rate of 1-15 s.
9. Use of a single matrix lyophilized excipient according to any one of claims 1-8 in a cosmetic skin care product.
10. The freeze-dried preparation for beauty and skin care is characterized in that the raw materials comprise single matrix liquid and skin care active ingredients; the single matrix solution is silk fibroin aqueous solution.
11. The lyophilized cosmetic skin care formulation of claim 10, wherein the concentration of the silk fibroin in the single matrix fluid is 0.0001% to 75%.
12. The lyophilized cosmetic skin care formulation of claim 11, wherein the concentration of the silk fibroin in the single matrix fluid is 0.0001% to 1%; the mass of the skin care active component accounts for 0.0001-25% of the total mass of the single matrix liquid;
the skin care active ingredients include peptides and plant extracts; the peptides comprise one or a mixture of glutathione, tripeptide-1, acetyl hexapeptide-8, nonapeptide-1, acetyl tetrapeptide-2, carnosine and copper peptide in any proportion; the plant extract comprises one or more of centella asiatica extract, angelica root extract, mastic resin extract, cucumber fruit extract, lavender extract, rose extract, ginger root extract, ganoderma lucidum extract and oat extract.
13. The lyophilized cosmetic skin care formulation of claim 11, wherein the concentration of the silk fibroin in the single matrix fluid is 1% to 30%; the mass of the active ingredients accounts for 0.0001-60% of the total mass of the single matrix liquid;
the active ingredients comprise one or a mixture of squalane, diglycerol, jojoba oil, fullerene, cannabidiol, coenzyme Q10, SOD, VA and derivatives, VE and derivatives, VB3, biotin, pantothenic acid and derivatives, VC and derivatives, saponin and flavone in any proportion.
14. The lyophilized cosmetic skin care formulation of claim 11, wherein the concentration of silk fibroin in the single matrix fluid is 30% -75%; the mass of the active ingredients accounts for 0.0001-25% of the total mass of the single matrix liquid;
the active ingredients comprise one or a mixture of tetrahydropyrane triol, glycerol glucoside, baicalin and ferulic acid in any proportion.
15. The lyophilized cosmetic skin care formulation of claim 10, further comprising an adjunct ingredient comprising one or more of an emulsifier, a humectant, a pigment, and a fragrance; the emulsifier comprises one or a mixture of poloxamer, polyglycerol ester and tween at any proportion.
16. Use of a lyophilized cosmetic skin care formulation according to any one of claims 10 to 15 in the field of cosmetic skin care.
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Application publication date: 20220816 |