CN108836979A - A kind of preparation method of sodium hyaluronate reparation patch and reparation patch and reparation patch Essence - Google Patents

A kind of preparation method of sodium hyaluronate reparation patch and reparation patch and reparation patch Essence Download PDF

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CN108836979A
CN108836979A CN201810552610.0A CN201810552610A CN108836979A CN 108836979 A CN108836979 A CN 108836979A CN 201810552610 A CN201810552610 A CN 201810552610A CN 108836979 A CN108836979 A CN 108836979A
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sodium
sodium hyaluronate
polyglutamic acid
parts
essence
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韩晓燕
李艳霞
李丙华
姜杰
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Harbin Yun Mei Da Biotechnology Co Ltd
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Harbin Yun Mei Da Biotechnology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728Hyaluronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/785Polymers containing nitrogen
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/10Anti-acne agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/16Emollients or protectives, e.g. against radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses a kind of sodium hyaluronate reparation patch and the preparation methods of reparation patch and reparation patch Essence, belong to pharmaceutical technology field.The Essence of reparation patch is by acetylation Sodium Hyaluronate, macromolecule Sodium Hyaluronate, small-molecular-weight Sodium Hyaluronate; scintilla amount Sodium Hyaluronate, macromolecular polyglutamic acid sodium, small molecule polyglutamic acid sodium; scintilla polyglutamic acid sodium, preservative and water for injection are prepared.The present invention also provides a kind of preparation method of Essence for sodium hyaluronate reparation patch and the preparation methods of sodium hyaluronate reparation patch.Reparation patch of the invention not only can be carried out daily facial moisturizing moisturizing, can more treat light moderate face acnes (I-III grade that is equivalent to acne);The acne more superficial depressed scar scar caused by reasons such as afterwards;Pigmentation;The inflammation such as erythema, oedema, scorching hot after the iatrotechnics such as skin allergy, laser photon, product safety, effectively.

Description

A kind of sodium hyaluronate reparation patch and reparation patch and reparation patch Essence Preparation method
Technical field
The present invention relates to the preparation sides of a kind of sodium hyaluronate reparation patch and reparation patch and reparation patch Essence Method belongs to pharmaceutical technology field.
Background technique
How the target that the always mankind that remain youthful forever constantly pursue keeps the year of face particularly with the Ms to like to be beautiful Lightization, at permanent project.Currently a popular beauty parlor's injection sodium hyaluronate is exactly one of its method, sodium hyaluronate, chemical name For Sodium Hyaluronate, it is widely present in the physiological activator of animal and human body, in human skin, synovium of joint liquid, umbilical cord, room It is distributed in water and vitreum, is the important composition of skin water lock moisturizing, the content of sodium hyaluronate can be with the increase at age And reduce, sodium hyaluronate begins to be lost after 25 years old, and 30 years old when is only left 25% when being left with the 65% of the brephic, 60 years old, into And cause dry skin water shortage and aging, and generate wrinkle, the problems such as coarse, the dark and gloomy and colour of skin is uneven.Supplement is saturating at present The mode of bright matter acid sodium has two kinds substantially:Subcutaneous injection takes orally.But inject sodium hyaluronate need profession beauty mechanism into Row, and price is higher, and has postoperative risk.How to seek to a kind of simple, safety, effective method, allows hyaluronic acid Sodium can also play its both effectiveness, content of the supplement subcutaneous Sodium Hyaluronate of human body, to realize other than injection of skin mode Reach solution skin aging, scar, it is obscure the problems such as, become new research and development project.
Summary of the invention
To solve the problem of face acnes, pigmentation and epigenetic-surface reworking laser photon post-operation inflammatory.The present invention provides The preparation method of a kind of sodium hyaluronate reparation patch and reparation patch and reparation patch Essence, the technical solution of use It is as follows:
It is pasted the purpose of the present invention is to provide a kind of sodium hyaluronate reparation patch, the sodium hyaluronate reparation Essence is by acetylation Sodium Hyaluronate, macromolecule Sodium Hyaluronate, small-molecular-weight Sodium Hyaluronate, scintilla amount hyalomitome Sour sodium, macromolecule polyglutamic acid sodium, small-molecular-weight polyglutamic acid sodium, scintilla amount polyglutamic acid sodium, preservative and injection Water is prepared, wherein:The molecular weight of the macromolecule Sodium Hyaluronate is -180 ten thousand dalton of 1,500,000 dalton, described The molecular weight of small-molecular-weight Sodium Hyaluronate is -40 ten thousand dalton of 200,000 dalton, point of the scintilla amount Sodium Hyaluronate Son amount is less than 10,000 dalton;The molecular weight of the macromolecule polyglutamic acid sodium is ten thousand dalton of 100-120, the small molecule The molecular weight for measuring polyglutamic acid sodium is -20 ten thousand dalton of 100,000 dalton, and the molecular weight of the scintilla amount polyglutamic acid sodium is small In 10,000 dalton;It is in terms of 1000 parts by Essence total weight, the parts by weight of each component are in Essence:Acetylation hyalomitome 0.5 part -1 part of sour sodium;5 parts -10 parts of macromolecule Sodium Hyaluronate;1.5 parts -2 parts of small-molecular-weight Sodium Hyaluronate, scintilla amount 3 parts -5 parts of Sodium Hyaluronate, 1 part -5 parts of macromolecule polyglutamic acid sodium, 1 part -3 parts of small-molecular-weight polyglutamic acid sodium, scintilla 1 part -10 parts of polyglutamic acid sodium of amount, 2 parts of preservative, surplus is supplied by water for injection.
Preferably, macromolecule polyglutamic acid sodium in the Essence, small-molecular-weight polyglutamic acid sodium, the poly- paddy of scintilla amount The parts by weight of propylhomoserin sodium are respectively:2 parts of macromolecule polyglutamic acid sodium, 2 parts of small-molecular-weight polyglutamic acid sodium, scintilla amount are poly- 3 parts of sodium glutamate.It is highly preferred that being in terms of 1000 parts by Essence total weight, the parts by weight of each component are in Essence:Acetyl Change 1 part of Sodium Hyaluronate;8 parts of macromolecule Sodium Hyaluronate;2 parts of small-molecular-weight Sodium Hyaluronate, scintilla amount hyaluronic acid 5 parts of sodium, 2 parts of macromolecule polyglutamic acid sodium, 2 parts of small-molecular-weight polyglutamic acid sodium, 3 parts of sodium of scintilla amount polyglutamic acid, anti-corrosion 2 parts of agent, surplus is supplied by water for injection.
Preferably, the preservative is made of nipagin A sodium and Sodium Propyl Hydroxybenzoate.
It is highly preferred that the ratio between mass fraction of the nipagin A sodium and Sodium Propyl Hydroxybenzoate is 1: 1。
The present invention provides a kind of preparation methods of the Essence of above-mentioned sodium hyaluronate reparation patch, according to following step It is rapid to carry out:
1) preservative is mixed with water for injection, dissolves preservative;
2) acetylation Sodium Hyaluronate and scintilla Sodium Hyaluronate, scintilla polyglutamic acid sodium is added after preservative dissolution It stirs and evenly mixs;
3) continue that micromolecule hyaluronic acid sodium is successively added into the mixed liquor of step 2), small molecule polyglutamic acid sodium and big Numerator sodium hyaluronate, macromolecular polyglutamic acid sodium stir and evenly mix, while being heated to 60 DEG C or less and continuing to stir 1h, are then allowed to stand To solution complete swelling at clear solution;
4) up to Essence after tune pH value to 5.5-6.5.
Preferably, stirring and evenly mixing described in step 2) and step 3) is carried out at 600 turns/min.
The present invention also provides a kind of preparation methods of above-mentioned sodium hyaluronate reparation patch, according to preceding claim Either method prepares Essence, and then face paper is fitted into packaging bag, in each packaging bag be packed into a face paper, then to Essence is added in each packaging bag, by packaging bag enclosing up to sodium hyaluronate reparation patch.
Preferably, 25mL-35mL Essence is added in each packaging bag.
Preferably, the face paper is spunlace non-woven cloth;The packaging bag is aluminium foil bag.
Preferably, the production environment of the preparation method the factorial production is 100,000 grades of cleaning shops.
Present invention process uses water for injection with water, can preferably control microorganism and the impurity of product.
Beneficial effect of the present invention:
Acetylation Sodium Hyaluronate in the present invention can repair impaired epidermal cell, enhance the barrier function of cuticula, effectively The evaporation of skin internal moisture is reduced, pachylosis, drying regime are improved;Macromolecule Sodium Hyaluronate:Molecular weight 150-180 ten thousand Dalton prevents skin internal moisture from evaporating to reach moisturizing by forming the hydration shell of layer of transparent in skin surface Purpose;Small-molecular-weight Sodium Hyaluronate:Ten thousand dalton of molecular weight 20-40, acts on keratoderma, be absorbed into 1000 times itself The moisture of weight, moistens skin, and bullet is glossy;Scintilla amount Sodium Hyaluronate molecular weight, can be by saturating less than 10,000 dalton Skin absorbs, and into inside skin, removes free radical, the effect that anti-inflammatory, inhibition germ generates, keeps skin bright and clean, increases for cell It grows and provides suitable place with differentiation, directly facilitate cell growth, break up, rebuild and repair etc., polyglutamic acid sodium can effectively store Product natural moisturizing factor slows down Sodium Hyaluronate degradation.
The present invention by by the Sodium Hyaluronate of the polyglutamic acid sodium of three kinds of different molecular weights and three kinds of different molecular weights and Acetylation Sodium Hyaluronate is used in compounding, and can make the polyglutamic acid sodium and three kinds of different molecular weights of three kinds of different molecular weights It acts synergistically each other between Sodium Hyaluronate and acetylation Sodium Hyaluronate, Sodium Hyaluronate and second can be further enhanced The effect of acylated Sodium Hyaluronate, obtains the resistance of enhancing skin reply environmental stimuli, anti-inflammatory, slows down allergy, inhibits black The effect that pigment is formed.
Formula sodium hyaluronate reparation patch according to the invention, not only can be carried out daily facial moisturizing moisturizing, beauty It is white, it goes to wrinkle.More importantly there is clinical effectiveness to the light moderate acne for the treatment of, wound healing;To acne more after, skin allergy Caused scar has desalination, the effect of reparation;To caused rubefaction after laser photon iatrotechnics, Mild edema, early stage color Plain calmness has therapeutic effect.
Specific embodiment
The present invention will be further described combined with specific embodiments below, but the present invention should not be limited by the examples.
The molecular weight of macromolecule Sodium Hyaluronate is -180 ten thousand dalton of 1,500,000 dalton, small-molecular-weight in the present invention The molecular weight of Sodium Hyaluronate is -40 ten thousand dalton of 200,000 dalton, and the molecular weight of scintilla amount Sodium Hyaluronate is less than 10,000 Er Dun;The molecular weight of macromolecule polyglutamic acid sodium is ten thousand dalton of 100-120, and the molecular weight of small-molecular-weight polyglutamic acid sodium is - 20 ten thousand dalton of 100000 dalton, the molecular weight of scintilla amount polyglutamic acid sodium is less than 10,000 dalton.Following embodiment is with big The molecular weight of molecular weight hyaluronic acid sodium is 1,800,000 dalton, and the molecular weight of small-molecular-weight Sodium Hyaluronate is 350,000 dalton, The molecular weight 0.7K dalton of scintilla amount Sodium Hyaluronate;The molecular weight of macromolecule polyglutamic acid sodium is 1,000,000 dalton, The molecular weight of small-molecular-weight polyglutamic acid sodium is 120,000 dalton, and the molecular weight of scintilla amount polyglutamic acid sodium is less than 5K dongle , the molecular weight of acetylation Sodium Hyaluronate is to be illustrated for 30,000 dalton (degree of substitution 3).
Embodiment 1:
It present embodiments provides a kind of sodium hyaluronate reparation patch and its Essence and repairs the preparation method of patch, tool Body formula and preparation method are as follows:
One, sodium hyaluronate reparation patch essence formula of liquid is as follows shown in square table 1:
Essence formula of liquid is pasted in 1 sodium hyaluronate reparation of table
Two, the technological process of production and process conditions
1, production environment:100000 grades of cleaning shops
2, Sodium Hyaluronate quality standard meets main points requirement
3, operating process
A, the preparation method of the Essence of sodium hyaluronate reparation patch, carries out in accordance with the following steps:
1) water for injection is added in homogeneous tank, and quantitative preservative is added into water for injection, thoroughly dissolves;
2) acetylation Sodium Hyaluronate and scintilla Sodium Hyaluronate, scintilla polyglutamic acid sodium is added after preservative dissolution It is stirred and evenly mixed under 600 turns/min;
3) continue successively to be added micromolecule hyaluronic acid sodium, small molecule polyglutamic acid sodium and big into the mixed liquor of step 2) The polyglutamic acid sodium of numerator sodium hyaluronate, macromolecular stirs and evenly mixs under 600 turns/min, while adding to homogeneous tank mixed liquor Heat, temperature are no more than 60 DEG C, and after mixing 1h, static 1h is allowed to go completely into clear solution;
4) up to Essence after tune pH value to 5.5-6.5, Essence is filling, it is wrapped after the filling inspection of semifinished product is qualified Dress.
B, the preparation method of sodium hyaluronate reparation patch, this method are:
Face paper (spunlace non-woven cloth) is fitted into aluminium foil bag, 25-35ml Essence is added, aluminium foil bag seals up to medical Sodium Hyaluronate reparation patch.
Product of the present invention surface is white to flaxen wet film, and clean, free from smutting, product of the present invention should sufficiently moisten Wet, extrudable liquid must not be less than 5ml, and between extrusion liquid pH value 60-7.0, hyaluronic acid na concn is not less than 1.5mg/ml, bacterium Number should be less than 100cfu/ml, and yeast and mold number should be less than 100cfu/ml, and (staphylococcus aureus, verdigris are false for pathogenic bacteria Monad) it must not detect.
C, application method:
External application.Illing skin is cleaned, this product outer packing is opened, sodium hyaluronate face reparation patch expansion is taken out, applies In on skin of face, light pressure makes non-woven fabrics be adjacent to skin.
Treat light moderate acne and acne healing after early stage pigmentation and scar application method:Mild acne patient is every It 1 time, 1 patch, every patch 30 minutes are used continuously one week every time, then weekly 2~3 times, as a treatment course every two weeks;Moderate Cuo 1 time a day, 1 patch, every patch 30 minutes, are used continuously one month, then weekly 2~3 times, each moon is one sore patient every time The course for the treatment of.
Treatment mitigates rear acne, the rear early stage pigmentation of skin allergy, laser photon treatment post-operation inflammatory and scar Application method:1 time a day, 1 patch, every patch 30 minutes are used continuously one week every time, and then weekly 2~3 times, be every two weeks one A course for the treatment of.
Embodiment 2
The present embodiment the difference from embodiment 1 is that:Essence formula of liquid 2 institute of square table as follows is pasted in sodium hyaluronate reparation Show, the preparation method of sodium hyaluronate reparation patch and its Essence is same as Example 1:
Essence formula of liquid is pasted in 2 sodium hyaluronate reparation of table
Embodiment 3
The present embodiment the difference from embodiment 1 is that:Essence formula of liquid 3 institute of square table as follows is pasted in sodium hyaluronate reparation Show, the preparation method of sodium hyaluronate reparation patch and its Essence is same as Example 1:
Essence formula of liquid is pasted in 3 sodium hyaluronate reparation of table
The effect that can be obtained is pasted in sodium hyaluronate reparation to illustrate the invention, has carried out following experiment, below It tests and is illustrated by taking sodium hyaluronate reparation patch prepared by embodiment 1 as an example, other embodiments can also obtain following Effect:
One, clinical trial
1, experimental study object:
1.1 light moderate face acnes (I-III grade that is equivalent to acne) patient 36:Observing skin lesion improves situation
1.2 pigmentation patients 36, observation pigmentation improve situation
1.3 epigenetic-surface reworking patients 36, observation scar improve situation
1.4 skin allergy, laser photon etc. treat postoperative patient 36:Observe inflammation:Erythema, oedema, scorching hot treatment have Imitate situation.
2 experimental study times
Experimental period:On July 18th, 2013, first case entered group;The last one subject is in 10 end of day January in 2014 Follow-up.
3, experiment purpose:Evaluation sodium hyaluronate reparation patch treats light moderate face acnes and (is equivalent to the I-of acne III grade);The acne more superficial depressed scar scar caused by reasons such as afterwards;Pigmentation;The treatment such as skin allergy, laser photon The validity and safety of the inflammation healings such as postoperative erythema, oedema, scorching hot
4, experimental design:
It participates in experimenter and excludes following problems:
4.1 suffer from IV grade and IV grade or more inflammatory reaction person or acne severe infection person;
There are open wound or rotten to the corn face person in 4.2 acne affected parts;
4.3 suffer from serious systemic disease and other skin disease persons, as lupus erythematosus, psoriasis, eczema, mechanicalness dermatitis, Chemically dermatitis, mycotic dermatitis, parasitic dermatitis etc.;
4.4 use hormone (glucocorticoid, contraceptive product and antiandrogen etc.) person in nearly one month;
4.5, which are mentally ill, history or has dependent to alcohol;
4.6 Pregnant and lactant women;
4.7 cannot be by the fine partner of test plan;
Other clinical test persons are participated in 4.8 3 months;
Other externally applied drug persons are used in 4.9 2 weeks.
5, curative effect index
5.1 curative effect indexs
5.1.1 face acnes therapeutic evaluation
The rear pigmentation colorimetric card scoring difference comparsion of acne:Divide colorimetric card to the pretherapy and post-treatment color of patient using 1-15 Heavy situation scores
5.1.2:Pigmentation and epigenetic-surface reworking therapeutic evaluation
The heavy colorimetric card scoring difference comparsion of color:Colorimetric card is divided to comment the heavy situation of patient's color before and after treatment using 1-15 Point
5.1.3:Inflammation treatment effect assessment after the iatrotechnics such as skin allergy, laser photon:
Visual observations:Erythema, oedema, scorching hot situation are evaluated.
5.3 safety indexes:
5.3.1 vital sign:Body temperature, heart rate, breathing, systolic pressure, diastolic pressure;
5.3.2 skin adverse reaction is observed:Erythema, oedema, scorching hot, itch, drying, furfur etc.;
6:Statistical analysis:
It is pasted to experiment patient is participated in using the sodium reparation of hyaluronic acid acid:
6.1, for early stage pigmentation, scar patient after light moderate acne, acne healing:Mild acne patient daily 1 Secondary, 1 patch, every patch 30 minutes are used continuously one week every time, then weekly 2~3 times, as a treatment course every two weeks;Moderate acne is suffered from 1 time a day, 1 patch, every patch 30 minutes, are used continuously one month, then weekly 2~3 times, each moon is a treatment person every time Journey.
6.2, for after mitigating acne more, inflammatory patients after skin allergy, laser photon iatrotechnics:More 1 time a day, every time 1 patch, every patch 30 minutes are used continuously one week, then weekly 2~3 times, as a treatment course every two weeks.
1 experimental result of table
Adapt to symptom Experiment number (example) Efficiently individual quantity (example) Efficient (%) Safety (%)
Patients with acne 36 35 97.2 100
Epigenetic-surface reworking 36 34 91.6 100
Pigmentation 36 34 91.6 100
Laser photon beauty post-operation inflammatory 36 35 97.2 100
8, experiment conclusion:It is light that treatment is attached to by colour atla comparison and the scoring evaluation sodium hyaluronate reparation of ECCA weight Moderate face acnes (I-III grade that is equivalent to acne);The acne more superficial depressed scar scar caused by reasons such as afterwards;Pigment It is calm;The inflammation healings such as erythema, oedema, scorching hot have validity and safety after the iatrotechnics such as skin allergy, laser photon.
Two, three kinds of different molecular weight polyglutamic acid sodium are with the influence for comparing therapeutic effect
Experiment 1:Patch is repaired according to formula and the method preparation of embodiment 1;
Experiment 2:Macromolecular polyglutamic acid sodium 7g does not contain scintilla polyglutamic acid sodium and small molecule polyglutamic acid sodium, His ingredient and content are formulated with embodiment 1 identical, and preparation method is identical as the preparation method of embodiment 1;
Experiment 3:Small molecule polyglutamic acid sodium 7g does not contain scintilla polyglutamic acid sodium and macromolecular polyglutamic acid sodium, His ingredient and content are formulated with embodiment 1 identical, and preparation method is identical as the preparation method of embodiment 1;
Experiment 4:Scintilla polyglutamic acid sodium 7g does not contain macromolecular polyglutamic acid sodium and macromolecular polyglutamic acid sodium, His ingredient and content are formulated with embodiment 1 identical, and preparation method is identical as the preparation method of embodiment 1;
Experiment 5:Macromolecular polyglutamic acid sodium 5g, small molecule polyglutamic acid sodium 1g and scintilla polyglutamic acid sodium 1g, other Ingredient and content are formulated with embodiment 1 identical, and preparation method is identical as the preparation method of embodiment 1;
Experiment 6:Macromolecular polyglutamic acid sodium 1g, small molecule polyglutamic acid sodium 1g and scintilla polyglutamic acid sodium 5g, other Ingredient and content are formulated with embodiment 1 identical, and preparation method is identical as the preparation method of embodiment 1;
It is pasted using the reparation of experiment 1-6, carries out clinical test, experimental result such as table 2 according to the method in above-mentioned experiment one It is shown.
2 experimental result of table
By the data in table 2:Individually use macromolecular polyglutamic acid sodium, small molecule polyglutamic acid sodium and scintilla The effect of polyglutamic acid sodium is obviously worse than macromolecular polyglutamic acid sodium, small molecule polyglutamic acid sodium and scintilla polyglutamic acid sodium The experimental group of compounding, and known to comparative experiments 1,5 and 6:The polyglutamic acid sodium of different molecular weight matches different, therapeutic effect It is not identical, wherein the therapeutic effect of experiment 1 is best, i.e., when macromolecular polyglutamic acid sodium, small molecule polyglutamic acid sodium and scintilla Polyglutamic acid sodium is according to 2:2:3 effects when being matched are best.
Two, three kinds of different molecular weight polyglutamic acid sodium and three kinds of different molecular weight hyaluronic acids and acetylation hyaluronic acid Synergistic effect
Test 1 (+three kinds of acetylation Sodium Hyaluronate+three kinds of Sodium Hyaluronate polyglutamic acid sodium):According to matching for embodiment 1 Patch is repaired in side and method preparation
Test 2 (+three kinds of Sodium Hyaluronates of acetylation Sodium Hyaluronate):Without containing macromolecular polyglutamic acid sodium, small molecule Polyglutamic acid sodium and scintilla polyglutamic acid sodium, other compositions and content are formulated identical, preparation method and implementation with embodiment 1 The preparation method of example 1 is identical;
Test 3 (+three kinds of polyglutamic acid sodium of three kinds of Sodium Hyaluronates):Without containing acetylation Sodium Hyaluronate, other compositions It is formulated with embodiment 1 with content identical, preparation method is identical as the preparation method of embodiment 1;
Test 4 (+three kinds of polyglutamic acid sodium of acetylation Sodium Hyaluronate):Without containing macromolecule Sodium Hyaluronate, small point Son amount Sodium Hyaluronate and scintilla amount Sodium Hyaluronate, other compositions and content are formulated identical, preparation method with embodiment 1 It is identical as the preparation method of embodiment 1;
It is pasted using the reparation of experiment 1-4, carries out clinical test, experimental result such as table 3 according to the method in above-mentioned experiment one It is shown.
3 experimental result of table
By comparing known to the result of experiment 1-4:Three kinds of polyglutamic acid sodium and acetylation Sodium Hyaluronate and three kinds are transparent The scheme (experiment 1) of matter acid sodium compounding is substantially better than the scheme that acetylation Sodium Hyaluronate is individually compounded with three kinds of Sodium Hyaluronates The scheme that (being not added with three kinds of polyglutamic acid sodium), three kinds of Sodium Hyaluronates are individually compounded with three kinds of polyglutamic acid sodium (is not added with second Acylated Sodium Hyaluronate), acetylation Sodium Hyaluronate individually compounded with three kinds of polyglutamic acid sodium scheme (be not added with three kinds it is transparent Matter acid sodium), it can thus be appreciated that:Three kinds of polyglutamic acid sodium and acetylation Sodium Hyaluronate are used together with three kinds of Sodium Hyaluronates can be with Synergistic mutually, three kinds of polyglutamic acid sodium can promote the hair of acetylation Sodium Hyaluronate and three kinds of Sodium Hyaluronate effectiveness It waves, so that the effective percentage of each symptom is further promoted.
Although the present invention has been disclosed in the preferred embodiment as above, it is not intended to limit the invention, any to be familiar with this The people of technology can do various changes and modification, therefore protection of the invention without departing from the spirit and scope of the present invention Range should subject to the definition of the claims.

Claims (10)

1. a kind of sodium hyaluronate reparation patch, which is characterized in that the Essence of the sodium hyaluronate reparation patch by Acetylation Sodium Hyaluronate, macromolecule Sodium Hyaluronate, small-molecular-weight Sodium Hyaluronate, scintilla amount Sodium Hyaluronate, greatly Molecular weight polyisoprene sodium glutamate, small-molecular-weight polyglutamic acid sodium, scintilla amount polyglutamic acid sodium, preservative and water for injection preparation and At, wherein:The molecular weight of the macromolecule Sodium Hyaluronate is -180 ten thousand dalton of 1,500,000 dalton, the small-molecular-weight The molecular weight of Sodium Hyaluronate is -40 ten thousand dalton of 200,000 dalton, and the molecular weight of the scintilla amount Sodium Hyaluronate is less than 1 Ten thousand dalton;The molecular weight of the macromolecule polyglutamic acid sodium is ten thousand dalton of 100-120, the small-molecular-weight polyglutamic acid The molecular weight of sodium is -20 ten thousand dalton of 100,000 dalton, and the molecular weight of the scintilla amount polyglutamic acid sodium is less than 10,000 dongles ?;It is in terms of 1000 parts by Essence total weight, the parts by weight of each component are in Essence:0.5 part of acetylation Sodium Hyaluronate- 1 part;5 parts -10 parts of macromolecule Sodium Hyaluronate;1.5 parts -2 parts of small-molecular-weight Sodium Hyaluronate, scintilla amount Sodium Hyaluronate 3 parts -5 parts, 1 part -5 parts of macromolecule polyglutamic acid sodium, 1 part -3 parts of small-molecular-weight polyglutamic acid sodium, scintilla amount polyglutamic acid 1 part -10 parts of sodium, 2 parts of preservative, surplus is supplied by water for injection.
2. sodium hyaluronate reparation patch according to claim 1, which is characterized in that macromolecule in the Essence The parts by weight of polyglutamic acid sodium, small-molecular-weight polyglutamic acid sodium, scintilla amount polyglutamic acid sodium are respectively:The poly- paddy of macromolecule 2 parts of propylhomoserin sodium, 2 parts of small-molecular-weight polyglutamic acid sodium, 3 parts of sodium of scintilla amount polyglutamic acid.
3. sodium hyaluronate reparation patch according to claim 1, which is characterized in that with Essence total weight for 1000 Part is counted, and the parts by weight of each component are in Essence:1 part of acetylation Sodium Hyaluronate;8 parts of macromolecule Sodium Hyaluronate;It is small 2 parts of molecular weight hyaluronic acid sodium, 5 parts of scintilla amount Sodium Hyaluronate, 2 parts of macromolecule polyglutamic acid sodium, the poly- paddy of small-molecular-weight 2 parts of propylhomoserin sodium, 3 parts of sodium of scintilla amount polyglutamic acid, 2 parts of preservative, surplus is supplied by water for injection.
4. sodium hyaluronate reparation patch according to claim 1 or 2 or 3, which is characterized in that the preservative is by right Nipagin A sodium and Sodium Propyl Hydroxybenzoate composition.
5. sodium hyaluronate reparation patch according to claim 4, which is characterized in that the ethyl-para-hydroxybenzoate The ratio between mass fraction of sodium and Sodium Propyl Hydroxybenzoate is 1:1.
6. a kind of preparation method of the Essence for the patch of sodium hyaluronate reparation described in claim 1, which is characterized in that It carries out in accordance with the following steps:
1) preservative is mixed with water for injection, dissolves preservative;
2) acetylation Sodium Hyaluronate and scintilla Sodium Hyaluronate, the stirring of scintilla polyglutamic acid sodium are added after preservative dissolution It mixes;
3) continue that micromolecule hyaluronic acid sodium, small molecule polyglutamic acid sodium and macromolecular are successively added into the mixed liquor of step 2) Sodium Hyaluronate, macromolecular polyglutamic acid sodium stir and evenly mix, while being heated to 60 DEG C or less and continuing to stir 1h, are then allowed to stand to molten Liquid complete swelling is at clear solution;
4) up to Essence after tune pH value to 5.5-6.5.
7. preparation method according to claim 6, which is characterized in that stirred and evenly mixed described in step 2) and step 3) be It is carried out under 600 turns/min.
8. a kind of preparation method of the patch of sodium hyaluronate reparation described in claim 1, which is characterized in that according to claim Any the method for 5-7 prepares Essence, and then face paper is fitted into packaging bag, and a facial mask is packed into each packaging bag Then Essence is added into each packaging bag in paper, by packaging bag enclosing up to sodium hyaluronate reparation patch.
9. preparation method according to claim 8, which is characterized in that 25mL-35mL Essence is added in each packaging bag.
10. preparation method according to claim 8, which is characterized in that the face paper is spunlace non-woven cloth;The packaging Bag is aluminium foil bag.
CN201810552610.0A 2018-05-31 2018-05-31 A kind of preparation method of sodium hyaluronate reparation patch and reparation patch and reparation patch Essence Pending CN108836979A (en)

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CN112294706A (en) * 2019-07-31 2021-02-02 太和康美(北京)中医研究院有限公司 Moisturizing composition and preparation method and application thereof
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CN112156033B (en) * 2020-10-16 2021-05-28 南京百姿雅生物科技有限公司 Essence containing ultra-small molecule sodium hyaluronate and preparation method thereof
CN113975197A (en) * 2021-11-03 2022-01-28 西安德诺海思医疗科技有限公司 Composition containing sodium polyglutamate and dressing using composition
CN113975197B (en) * 2021-11-03 2023-08-29 西安德诺海思医疗科技有限公司 Composition containing sodium polyglutamate and dressing applied by composition

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