CN111467326A - Process for manufacturing trehalose repair patch capable of promoting repair of damaged skin barrier - Google Patents

Process for manufacturing trehalose repair patch capable of promoting repair of damaged skin barrier Download PDF

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CN111467326A
CN111467326A CN202010435054.6A CN202010435054A CN111467326A CN 111467326 A CN111467326 A CN 111467326A CN 202010435054 A CN202010435054 A CN 202010435054A CN 111467326 A CN111467326 A CN 111467326A
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舒凌
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Chayan Biotechnology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00Medicinal preparations containing organic active ingredients
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    • A61K31/7016Disaccharides, e.g. lactose, lactulose
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders

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Abstract

The invention provides a manufacturing process of a trehalose repair patch capable of promoting repair of a damaged skin barrier, wherein the repair patch comprises the following raw materials: 46-98 parts of trehalose, 13-25 parts of sea buckthorn polysaccharide, 44-65 parts of sweet almond oil, 25-50 parts of argania spinosa kernel oil, 13-20 parts of helicase, 5-8 parts of menthol, 25-35 parts of pentanediol, 3.0-5.0 parts of phenoxyethanol, 2.3-3.5 parts of triethanolamine, 505-652 parts of water and 28-32 parts of a film forming agent; the trehalose repairing agent is permeated into pores of the non-woven fabric through a high-voltage electrostatic spraying process technology, atomization treatment is carried out, process parameters are controlled, the skin barrier trehalose repairing paste with high skin application performance is obtained, the transdermal absorption capacity of functional components is enhanced, and the drug effect is more durable.

Description

Process for manufacturing trehalose repair patch capable of promoting repair of damaged skin barrier
Technical Field
The invention relates to the technical field of medicines, in particular to a trehalose repair patch manufacturing process capable of promoting the repair of a damaged skin barrier.
Background
In recent years, the medical plastic beauty industry of China is different military prominence, the development is rapid, the demand market is vigorous, beauty in the 21 st century is a necessary living need of young women, laser treatment is a novel medical beauty technology which is made up at present, most of patients with skin problems need to receive laser treatment, laser beauty actually utilizes lasers with different types and wavelengths to cause certain influence on skin tissues, for example, the heat effect generated by the laser treatment can cause the reduction of the skin barrier function, so that the skin becomes sensitive, the main expression is inflammatory cell infiltration around dermal blood vessels, the epidermis has intracellular edema and intercellular edema, and erythema, swelling and even blister are generated;
however, some existing skin barrier repair patches are difficult to act through the epidermis, due to the unique histological structure, barrier effect, defense function and the like of the skin, the efficacy of the repair agent cannot be fully exerted, and the skin and the drugs generate mutual exclusion effect and limit the function of the repair patches.
Disclosure of Invention
In view of the above, the present invention provides a manufacturing process of a trehalose repair patch capable of promoting repair of damaged skin barrier, so as to solve the above problems.
The technical scheme of the invention is realized as follows: a manufacturing process of a trehalose repair patch capable of promoting repair of damaged skin barriers comprises the following steps: the method comprises the following steps:
(1) preparing a trehalose repairing agent:
a. the composite material comprises the following raw materials in parts by weight: 46-98 parts of trehalose, 13-25 parts of sea buckthorn polysaccharide, 44-65 parts of sweet almond oil, 25-50 parts of argania spinosa kernel oil, 13-20 parts of helicase, 5-8 parts of menthol, 25-35 parts of pentanediol, 3.0-5.0 parts of phenoxyethanol, 2.3-3.5 parts of triethanolamine, 505-652 parts of water and 28-32 parts of a film forming agent;
b. adding 50% of water in the total amount into a preparation tank, adding trehalose and hippophae rhamnoides polysaccharide in a stirring state, stirring and dissolving for 20-40 min at a stirring frequency of 30-35 Hz to obtain a phase A, adding 1.0-1.2 times of composite phosphate solution, placing in a water bath oscillator, adjusting the pH value to be 6-8, and oscillating for 50-80 min at a temperature of 50-70 ℃ to obtain a phase B;
c. centrifuging the phase B at 5000-7000 rpm for 20-30 min, ultrafiltering the supernatant with an ultrafiltration membrane, allowing the ultrafiltration permeate to pass through an acid-base column at a flow rate of 5-7 m L/s, collecting the solution passing through the acid-base column as phase C,
d. and sequentially adding sweet almond oil, argania spinosa kernel oil, helicase, menthol, pentanediol, phenoxyethanol and a film forming agent into the phase C, adding the rest water, circularly homogenizing for 10-15 times by using a high-pressure homogenizer under the conditions of 80-140 MPa and 100-110 ℃, and adjusting the pH value of the solution to 4.5-6.5 by using triethanolamine to obtain the trehalose repairing agent.
(2) Preparing a trehalose repair patch:
and (3) permeating the obtained trehalose repairing agent into pores of the non-woven fabric through high-voltage electrostatic spraying, and then carrying out atomization treatment, wherein the spraying pressure of atomized water is 25-30 KPa, the front side is sprayed for 5-10 min, the back side is sprayed for 5-8 min, and the cycle times of the front side and the back side are alternately sprayed for 7-9 times, so that the trehalose repairing paste is obtained.
Further, the trehalose repairing agent comprises the following raw materials: 72 parts of trehalose, 22 parts of sea buckthorn polysaccharide, 55 parts of sweet almond oil, 39 parts of argania spinosa kernel oil, 16 parts of helicase, 6 parts of menthol, 30 parts of pentanediol, 4.0 parts of phenoxyethanol, 3.1 parts of triethanolamine, 550 parts of water and 30 parts of film forming agent.
Furthermore, the trehalose comprises α -trehalose, α -trehalose and β -trehalose in a mass ratio of 1:5: 5.
Further, the film forming agent is one or a combination of a plurality of polyvinylpyrrolidone, sodium carboxymethylcellulose, sodium alginate or polyvinyl alcohol.
Further, the flow rate of the high-voltage electrostatic spraying in the step (2) is 2.3-3.6 m L/h, and the voltage is 30-40 kV.
Compared with the prior art, the invention has the beneficial effects that:
(1) the invention selects raw materials aiming at the skin repair mechanism, improves the oil phase content of the raw materials, reduces the water phase content, is scientific in proportioning, can play a role in synergy, improves the skin repair function, avoids skin allergy caused after laser treatment, mixes trehalose and hippophae rhamnoides polysaccharide in proportion, can effectively enter cells to play a role of unique water substitution stress factors, replaces glycerin with argania spinosa kernel oil, contains more linoleic acid, gamma-linolenic acid and arachidic acid, is beneficial to the absorption of the repair patch, is better applied to the surface of the skin by adding a film-forming agent, can reduce water evaporation by forming a compact film on the outer layer, can effectively transfer the medicine into skin cells after the loose part of the inner layer is atomized and has large medicine-carrying capacity after contacting with the skin, and improves the skin transmittance of effective components;
(2) in the preparation process, the stirring frequency and time are strictly controlled, and the centrifugal liquid is centrifuged at a certain speed to achieve the purified centrifugal liquid, so that the high-pressure homogenization at the later stage is facilitated; in addition, the repairing agent permeates into pores of the non-woven fabric through high-voltage electrostatic spraying, the problem that the skin absorption permeability is low due to the fact that a medicament is absorbed by the non-woven fabric due to the fact that the non-woven fabric is uneven in thickness and mixed component distribution in a traditional method is avoided, the high pressure and the spraying speed are controlled to comb fibers, the uniformity and the functionality of the non-woven fabric are improved, the medicament is uniformly sprayed into the non-woven fabric, atomized water spraying is conducted, the effective small molecular weight of the medicament is effectively improved, the area covering the non-woven fabric is wide, the medicament solubility and the unit volume effective component concentration are improved, when the repairing paste is used, the small molecular weight and the largest area of the medicament can be covered to the outer layer of the non-woven fabric, namely the non-woven fabric is in contact with a skin layer, the repairing.
Detailed Description
In order to better understand the technical content of the invention, specific examples are provided below to further illustrate the invention.
The experimental methods used in the examples of the present invention are all conventional methods unless otherwise specified.
The materials, reagents and the like used in the examples of the present invention can be obtained commercially without specific description.
Example 1
A manufacturing process of a trehalose repair patch capable of promoting repair of damaged skin barriers comprises the following steps: the method comprises the following steps:
(1) preparing a trehalose repairing agent:
a. the sea buckthorn polysaccharide film forming agent comprises the following raw materials, by weight, 46 parts of trehalose, 13 parts of sea buckthorn polysaccharide, 44 parts of sweet almond oil, 25 parts of argania spinosa kernel oil, 13 parts of helicase, 5 parts of menthol, 25 parts of pentanediol, 3.0 parts of phenoxyethanol, 2.3 parts of triethanolamine, 505 parts of water and 28 parts of a film forming agent, wherein the trehalose comprises α -trehalose, α -trehalose and β -trehalose which are mixed according to a mass ratio of 1:5:5, and the film forming agent is polyvinylpyrrolidone;
b. adding 50% of water into a preparation tank, adding trehalose and hippophae rhamnoides polysaccharide in a stirring state, stirring for dissolving, stirring at a frequency of 32Hz for 30min to obtain phase A, adding 1.1 times of composite phosphate solution, placing in a water bath oscillator, adjusting pH to 7, and oscillating at 60 ℃ for 70min to obtain phase B;
c. centrifuging phase B at 6000rpm for 25min, ultrafiltering the supernatant with ultrafiltration membrane, passing the ultrafiltration permeate through acid-base column at flow rate of 6m L/s, collecting the filtrate as phase C,
d. adding sweet almond oil, argania spinosa kernel oil, helicase, menthol, pentanediol, phenoxyethanol and a film forming agent into the phase C in sequence, adding the rest water, circularly homogenizing for 12 times by a high-pressure homogenizer under the conditions of 110MPa and 105 ℃, and adjusting the pH value of the solution to 5 by triethanolamine to obtain the trehalose repairing agent.
(2) Preparing a trehalose repair patch:
and (3) permeating the obtained trehalose repairing agent into pores of the non-woven fabric through high-voltage electrostatic spraying, wherein the flow rate of the high-voltage electrostatic spraying is 3.2m L/h, the voltage is 35kV, then carrying out atomization treatment, the spraying pressure of the atomization water is 28KPa, spraying for 8min on the front side, spraying for 6min on the back side, and spraying for 8 times alternately on the front side and the back side to obtain the trehalose repairing paste.
Example 2
A manufacturing process of a trehalose repair patch capable of promoting repair of damaged skin barriers comprises the following steps: the method comprises the following steps:
(1) preparing a trehalose repairing agent:
a. the sea buckthorn polysaccharide film forming agent comprises the following raw materials, by weight, 98 parts of trehalose, 25 parts of sea buckthorn polysaccharide, 65 parts of sweet almond oil, 50 parts of argania spinosa kernel oil, 20 parts of helicase, 8 parts of menthol, 35 parts of pentanediol, 5.0 parts of phenoxyethanol, 3.5 parts of triethanolamine, 652 parts of water and 32 parts of a film forming agent, wherein the trehalose comprises α -trehalose, α -trehalose and β -trehalose which are mixed according to a mass ratio of 1:5:5, and the film forming agent is sodium carboxymethylcellulose;
b. adding 50% of water into a preparation tank, adding trehalose and hippophae rhamnoides polysaccharide in a stirring state, stirring for dissolving, stirring at a frequency of 32Hz for 30min to obtain phase A, adding 1.1 times of composite phosphate solution, placing in a water bath oscillator, adjusting pH to 7, and oscillating at 60 ℃ for 70min to obtain phase B;
c. centrifuging phase B at 6000rpm for 25min, ultrafiltering the supernatant with ultrafiltration membrane, passing the ultrafiltration permeate through acid-base column at flow rate of 6m L/s, collecting the filtrate as phase C,
d. adding sweet almond oil, argania spinosa kernel oil, helicase, menthol, pentanediol, phenoxyethanol and a film forming agent into the phase C in sequence, adding the rest water, circularly homogenizing for 12 times by a high-pressure homogenizer under the conditions of 110MPa and 105 ℃, and adjusting the pH value of the solution to 5 by triethanolamine to obtain the trehalose repairing agent.
(2) Preparing a trehalose repair patch:
and (3) permeating the obtained trehalose repairing agent into pores of the non-woven fabric through high-voltage electrostatic spraying, wherein the flow rate of the high-voltage electrostatic spraying is 3.2m L/h, the voltage is 35kV, then carrying out atomization treatment, the spraying pressure of the atomization water is 28KPa, spraying for 8min on the front side, spraying for 6min on the back side, and spraying for 8 times alternately on the front side and the back side to obtain the trehalose repairing paste.
Example 3
A manufacturing process of a trehalose repair patch capable of promoting repair of damaged skin barriers comprises the following steps: the method comprises the following steps:
(1) preparing a trehalose repairing agent:
a. the sea buckthorn polysaccharide-containing film forming agent comprises the following raw materials, by weight, 72 parts of trehalose, 22 parts of sea buckthorn polysaccharide, 55 parts of sweet almond oil, 39 parts of argania spinosa kernel oil, 16 parts of helicase, 6 parts of menthol, 30 parts of pentanediol, 4.0 parts of phenoxyethanol, 3.1 parts of triethanolamine, 550 parts of water and 30 parts of a film forming agent, wherein the trehalose comprises α -trehalose, α -trehalose and β -trehalose which are mixed according to a mass ratio of 1:5:5, and the film forming agent comprises sodium carboxymethylcellulose and sodium alginate which are mixed according to a mass ratio of 1: 1.3;
b. adding 50% of water into a preparation tank, adding trehalose and hippophae rhamnoides polysaccharide in a stirring state, stirring for dissolving, stirring at a frequency of 32Hz for 30min to obtain phase A, adding 1.1 times of composite phosphate solution, placing in a water bath oscillator, adjusting pH to 7, and oscillating at 60 ℃ for 70min to obtain phase B;
c. centrifuging phase B at 6000rpm for 25min, ultrafiltering the supernatant with ultrafiltration membrane, passing the ultrafiltration permeate through acid-base column at flow rate of 6m L/s, collecting the filtrate as phase C,
d. adding sweet almond oil, argania spinosa kernel oil, helicase, menthol, pentanediol, phenoxyethanol and a film forming agent into the phase C in sequence, adding the rest water, circularly homogenizing for 12 times by a high-pressure homogenizer under the conditions of 110MPa and 105 ℃, and adjusting the pH value of the solution to 5 by triethanolamine to obtain the trehalose repairing agent.
(2) Preparing a trehalose repair patch:
and (3) permeating the obtained trehalose repairing agent into pores of the non-woven fabric through high-voltage electrostatic spraying, wherein the flow rate of the high-voltage electrostatic spraying is 3.2m L/h, the voltage is 35kV, then carrying out atomization treatment, the spraying pressure of the atomization water is 28KPa, spraying for 8min on the front side, spraying for 6min on the back side, and spraying for 8 times alternately on the front side and the back side to obtain the trehalose repairing paste.
Example 4
A manufacturing process of a trehalose repair patch capable of promoting repair of damaged skin barriers comprises the following steps: the method comprises the following steps:
(1) preparing a trehalose repairing agent:
a. the sea buckthorn polysaccharide-containing film forming agent comprises the following raw materials, by weight, 72 parts of trehalose, 22 parts of sea buckthorn polysaccharide, 55 parts of sweet almond oil, 39 parts of argania spinosa kernel oil, 16 parts of helicase, 6 parts of menthol, 30 parts of pentanediol, 4.0 parts of phenoxyethanol, 3.1 parts of triethanolamine, 550 parts of water and 30 parts of a film forming agent, wherein the trehalose comprises α -trehalose, α -trehalose and β -trehalose which are mixed according to a mass ratio of 1:5:5, and the film forming agent comprises sodium carboxymethylcellulose and sodium alginate which are mixed according to a mass ratio of 1: 1.3;
b. adding 50% of water into a preparation tank, adding trehalose and hippophae rhamnoides polysaccharide in a stirring state, stirring for dissolving, stirring at a frequency of 30Hz for 20min to obtain phase A, adding 1.0 time of composite phosphate solution, placing in a water bath oscillator, adjusting pH to 6, and oscillating at 50 ℃ for 50min to obtain phase B;
c. centrifuging phase B at 5000rpm for 20min, ultrafiltering the supernatant with ultrafiltration membrane, passing the ultrafiltration permeate through acid-base column at flow rate of 5m L/s, collecting the filtrate as phase C,
d. adding sweet almond oil, argania spinosa kernel oil, helicase, menthol, pentanediol, phenoxyethanol and a film forming agent into the phase C in sequence, adding the rest water, circularly homogenizing for 10 times by a high-pressure homogenizer under the conditions of 80MPa and 100 ℃, and adjusting the pH value of the solution to 4.5 by triethanolamine to obtain the trehalose repairing agent.
(2) Preparing a trehalose repair patch:
and (3) permeating the obtained trehalose repairing agent into pores of the non-woven fabric through high-voltage electrostatic spraying, wherein the flow rate of the high-voltage electrostatic spraying is 2.3m L/h, the voltage is 30kV, then carrying out atomization treatment, the spraying pressure of atomized water is 25KPa, spraying for 5min on the front side, spraying for 5min on the back side, and spraying for 7 times alternately on the front side and the back side to obtain the trehalose repairing paste.
Example 5
A manufacturing process of a trehalose repair patch capable of promoting repair of damaged skin barriers comprises the following steps: the method comprises the following steps:
(1) preparing a trehalose repairing agent:
a. the sea buckthorn polysaccharide-containing film forming agent comprises the following raw materials, by weight, 72 parts of trehalose, 22 parts of sea buckthorn polysaccharide, 55 parts of sweet almond oil, 39 parts of argania spinosa kernel oil, 16 parts of helicase, 6 parts of menthol, 30 parts of pentanediol, 4.0 parts of phenoxyethanol, 3.1 parts of triethanolamine, 550 parts of water and 30 parts of a film forming agent, wherein the trehalose comprises α -trehalose, α -trehalose and β -trehalose which are mixed according to a mass ratio of 1:5:5, and the film forming agent comprises sodium carboxymethylcellulose and sodium alginate which are mixed according to a mass ratio of 1: 1.3;
b. adding 50% of water into a preparation tank, adding trehalose and hippophae rhamnoides polysaccharide in turn under stirring, stirring for dissolving, stirring at 35Hz for 40min to obtain phase A, adding 1.2 times of composite phosphate solution, placing in a water bath oscillator, adjusting pH to 8, and oscillating at 70 deg.C for 80min to obtain phase B;
c. centrifuging phase B at 7000rpm for 30min, ultrafiltering the supernatant with ultrafiltration membrane, allowing the filtrate to pass through acid-base column at 7m L/s, collecting the filtrate as phase C,
d. adding sweet almond oil, argania spinosa kernel oil, helicase, menthol, pentanediol, phenoxyethanol and a film forming agent into the phase C in sequence, adding the rest water, circularly homogenizing for 15 times by a high-pressure homogenizer under the conditions of 140MPa and 110 ℃, and adjusting the pH value of the solution to 6.5 by triethanolamine to obtain the trehalose repairing agent.
(2) Preparing a trehalose repair patch:
and (3) permeating the obtained trehalose repairing agent into pores of the non-woven fabric through high-voltage electrostatic spraying, wherein the flow rate of the high-voltage electrostatic spraying is 3.6m L/h, the voltage is 40kV, then carrying out atomization treatment, the spraying pressure of the atomization water is 30KPa, spraying for 10min on the front side, spraying for 8min on the back side, and spraying for 9 times alternately on the front side and the back side to obtain the trehalose repairing paste.
Example 6
The difference between the embodiment and the embodiment 3 is that the trehalose comprises α -trehalose, α -trehalose and β -trehalose in a mass ratio of 1:1: 1.
Example 7
The difference between the embodiment and the embodiment 3 is that in the preparation method of the skin barrier trehalose repair patch, the high-pressure electrostatic spraying flow rate of the step (2) is 4m L/h, and the voltage is 20 kV.
Comparative example 1
The trehalose repairing agent comprises the following raw materials: 100 parts of trehalose, 12 parts of sea buckthorn polysaccharide, 40 parts of sweet almond oil, 20 parts of argania spinosa kernel oil, 25 parts of helicase, 10 parts of menthol, 20 parts of pentanediol, 3 parts of phenoxyethanol, 2 parts of triethanolamine and 700 parts of water.
Comparative example 2
The trehalose repairing agent comprises the following raw materials: 72 parts of trehalose, 22 parts of sea buckthorn polysaccharide, 30 parts of sweet almond oil, 20 parts of argania spinosa kernel oil, 16 parts of helicase, 6 parts of menthol, 30 parts of pentanediol, 4.0 parts of phenoxyethanol, 3.1 parts of triethanolamine, 550 parts of water and 30 parts of film forming agent
Comparative example 3
The trehalose repairing agent comprises the following raw materials: 100 parts of trehalose, 12 parts of sea buckthorn polysaccharide, 55 parts of sweet almond oil, 39 parts of argania spinosa kernel oil, 16 parts of helicase, 6 parts of menthol, 30 parts of pentanediol, 4.0 parts of phenoxyethanol, 3.1 parts of triethanolamine, 850 parts of water and 30 parts of a film forming agent.
Comparative example 4
The comparative example differs from example 3 in that argania spinosa kernel oil in the starting material of the trehalose restoration agent is replaced with glycerol.
Comparative example 5
The difference between the comparative example and the example 3 is that the stirring frequency of the trehalose and the hippophae rhamnoides polysaccharide in the step b is 45 Hz.
Comparative example 6
This comparative example differs from example 3 in that the high-pressure homogenizer in step d has a pressure of 70MPa and a temperature of 80 ℃.
Comparative example 7
The difference between this comparative example and example 3 is that the trehalose repair agent was sprayed at a high temperature to penetrate into the voids of the nonwoven fabric in the preparation of the trehalose repair patch.
Comparative example 8
This comparative example differs from example 3 in that the trehalose patch was prepared without atomization.
First, animal skin irritation test
(1) The standard of the test basis is GB/T16886.10-2017 medical instrument biological evaluation
(2) Test system:
animal species: rabbit
Animal number: 12 pieces of
Body weight range: 2.0kg-2.2kg
(3) Animal selection: healthy, early adult, previously unused test animals were selected, and females were infertile and infertile.
(4) The test procedure was carried out by dividing rabbits into 3 groups of 4 rabbits each, removing the area to be dehaired, applying the sample prepared in example 1-3 wetted 2.5 × 2.5.5 cm nonwoven fabric directly to the test site, recording the condition of each contact site 1h, 24h, 48h and 72h after removing the applied material, and scoring according to the skin reaction classification scoring system in the standard.
Reaction of Stimulation scoring
Erythema and eschar formation
No erythema 0
Extremely slight erythema (barely visible) 1
Clear erythema 2
Moderate erythema 3
Eschar formation from severe erythema (mauve) to no erythema grading 4
Edema formation
Without edema 0
Extreme mild edema (barely visible) 1
Clear edema (swelling, clear swelling edge) 2
Moderate edema (swelling about 1mm) 3
Severe edema (swelling over 1mm and beyond the contact zone) 4
Stimulation peak score 8
(5) Evaluation of results
Figure BDA0002501924720000101
Second, determination of skin percutaneous absorption
(1) 48 rats were randomly selected and divided into 16 groups of 3 rats each, using the dressings of examples 1-7 and comparative examples 1-8, respectively, and a commercial trehalose patch, during which no repair product was used.
(2) The transdermal property is compared and researched by an in-vitro transdermal diffusion instrument, so that the in-vitro transdermal penetration capability of the trehalose repair patch is evaluated and researched.
(3) The determination method comprises maintaining 37 deg.C water bath in diffusion cell, fixing rat skin between supply cell and receiving cell, with dermis facing to the receiving cell, effective permeation area of 2.5 × 2.5.5 cm, filling receiving liquid in the receiving cell to prevent generation of bubbles, and receiving cell volume of 10ml, respectively uniformly coating the repairing paste on skin, placing cover glass on the supply chamber to prevent water evaporation, stirring with electromagnetic stirrer at 300rpm, taking out 1ml of receiving liquid at 2, 4, 6, and 8 hr, centrifuging sample solution at 15000rpm, collecting supernatant, analyzing with HP L C, and determining the accumulated transdermal absorption (μ g/cm) of each repairing paste according to the accumulated transdermal absorption2) The results are given in the following table:
Figure BDA0002501924720000111
as can be seen from the above table, in the preparation method of the skin barrier trehalose repair patch of the present invention, the examples 1 to 7 are compared with the comparative examples 1 to 3, it can be seen that the raw materials used in the invention are scientifically proportioned, the obtained repairing paste can effectively promote the skin absorption and transdermal permeability, the examples 1-7 are compared with the comparative example 4, the argania spinosa kernel oil can promote the synergistic effect of the raw materials, the examples 1-7 are compared with the comparative examples 5 and 6, the selection of preparation process parameters has certain influence on the preparation of the raw materials, and the examples 1-7 are compared with the comparative example 7, the repairing agent can be fully permeated into gaps of the non-woven fabric after being sprayed at high temperature, so that the absorption capacity of the repairing paste is improved, and compared with examples 1-7 and a comparative example 8, the repairing agent can be atomized after being sprayed at high temperature, so that the molecular weight can be refined, and the absorption permeability of the repairing paste can be further improved; examples 1-5 compare with example 6, trehalose compounded according to the proportion of the examples of the invention achieves better effect, examples 1-5 compare with example 7, the spray amount can be improved by selecting specific flow rate and voltage, and examples 1-3 compare with examples 4 and 5, which illustrate that the trehalose is preparedIn the process, the selection of each process parameter has a certain influence on the effect of the repair patch, compared with the examples 1-2 and 3, the scientific proportioning of the raw materials in the example 3 synergistically plays a role in the optimal proportioning to improve the absorption effect of the repair patch, and the transdermal mass is 1268.6 mug/cm in 8 hours2
Third, absorption assay for skin repair
(1) 160 volunteers aged 16-40 years, half of each of men and women were randomly selected, and divided into 16 groups, 10 persons in each group had their facial skin treated with laser, and the skin appeared to be itchy, dry, flushed, and atrophied, and the repair patches of examples 1-7 and comparative examples 1-8 and the commercial trehalose repair patch were used, respectively, during which no repair product was used.
(2) The using method comprises the following steps: after cleaning the face, the product was applied to the repaired site and the therapeutic effect was recorded after 5 days of use.
(3) And (3) effect measurement:
the effect is shown: more than 80% of symptoms such as skin pruritus, dryness, facial flushing, skin atrophy and thinning are disappeared.
The method has the following advantages: the symptoms of skin pruritus, dryness, facial flushing, skin atrophy and thinning disappear by 50-80%.
And (4) invalidation: skin itching, dryness, facial flushing, skin atrophy thinning, etc. < 50% or no change.
(4) The specific therapeutic effects are shown in the following table:
Figure BDA0002501924720000121
Figure BDA0002501924720000131
as can be seen from the above table, in examples 1 to 7, after 7 days, the symptoms such as skin itch, dryness, facial flushing, skin atrophy and thinning disappear by more than 80%; in comparative examples 1-8, after 7 days, symptoms such as skin itch, dryness, facial flushing, skin atrophy and thinning disappear by 50-80%; the commercial product has less than 50% disappearance of symptoms such as skin itch, dryness, facial flushing, skin atrophy and thinning after 7 days.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (5)

1. A manufacturing process of a trehalose repair patch capable of promoting repair of damaged skin barriers is characterized by comprising the following steps: the method comprises the following steps:
(1) preparing a trehalose repairing agent:
a. the composite material comprises the following raw materials in parts by weight: 46-98 parts of trehalose, 13-25 parts of sea buckthorn polysaccharide, 44-65 parts of sweet almond oil, 25-50 parts of argania spinosa kernel oil, 13-20 parts of helicase, 5-8 parts of menthol, 25-35 parts of pentanediol, 3.0-5.0 parts of phenoxyethanol, 2.3-3.5 parts of triethanolamine, 505-652 parts of water and 28-32 parts of a film forming agent;
b. adding 50% of water in the total amount into a preparation tank, adding trehalose and hippophae rhamnoides polysaccharide in a stirring state, stirring and dissolving for 20-40 min at a stirring frequency of 30-35 Hz to obtain a phase A, adding 1.0-1.2 times of composite phosphate solution, placing in a water bath oscillator, adjusting the pH value to be 6-8, and oscillating for 50-80 min at a temperature of 50-70 ℃ to obtain a phase B;
c. centrifuging the phase B at 5000-7000 rpm for 20-30 min, ultrafiltering the supernatant with an ultrafiltration membrane, allowing the ultrafiltration permeate to pass through an acid-base column at a flow rate of 5-7 m L/s, collecting the solution passing through the acid-base column as phase C,
d. adding sweet almond oil, argania spinosa kernel oil, helicase, menthol, pentanediol, phenoxyethanol and a film forming agent into the phase C in sequence, adding the rest water, circularly homogenizing for 10-15 times by using a high-pressure homogenizer under the conditions of 80-140 MPa and 100-110 ℃, and adjusting the pH value of the solution to 4.5-6.5 by using triethanolamine to obtain a trehalose repairing agent;
(2) preparing a trehalose repair patch:
and (3) permeating the obtained trehalose repairing agent into pores of the non-woven fabric through high-voltage electrostatic spraying, and then carrying out atomization treatment, wherein the spraying pressure of atomized water is 25-30 KPa, the front side is sprayed for 5-10 min, the back side is sprayed for 5-8 min, and the cycle times of the front side and the back side are alternately sprayed for 7-9 times, so that the trehalose repairing paste is obtained.
2. The process for preparing a trehalose patch for promoting repair of damaged skin barrier as claimed in claim 1, wherein: the trehalose repairing agent comprises the following raw materials: 72 parts of trehalose, 22 parts of sea buckthorn polysaccharide, 55 parts of sweet almond oil, 39 parts of argania spinosa kernel oil, 16 parts of helicase, 6 parts of menthol, 30 parts of pentanediol, 4.0 parts of phenoxyethanol, 3.1 parts of triethanolamine, 550 parts of water and 30 parts of film forming agent.
3. The manufacturing process of the trehalose repair patch capable of promoting the repair of the damaged skin barrier as claimed in claim 1, wherein the trehalose comprises α -trehalose, α -trehalose and β -trehalose in a mass ratio of 1:5: 5.
4. The process for preparing a trehalose patch for promoting repair of damaged skin barrier as claimed in claim 1, wherein: the film forming agent is one or a combination of a plurality of polyvinylpyrrolidone, sodium carboxymethylcellulose, sodium alginate or polyvinyl alcohol.
5. The manufacturing process of the trehalose repair patch capable of promoting the repair of the damaged skin barrier as claimed in claim 1, wherein the high-pressure electrostatic spraying flow rate in the step (2) is 2.3-3.6 m L/h, and the voltage is 30-40 kV.
CN202010435054.6A 2020-05-21 2020-05-21 Process for manufacturing trehalose repair patch capable of promoting repair of damaged skin barrier Pending CN111467326A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108813608A (en) * 2018-05-25 2018-11-16 陕西黄龙国寿堂生物工程有限公司 A kind of production method of sea-buckthorn wilsonii cream

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108813608A (en) * 2018-05-25 2018-11-16 陕西黄龙国寿堂生物工程有限公司 A kind of production method of sea-buckthorn wilsonii cream

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