CN108158978A - A kind of polymer waterborne gel and its preparation method and application - Google Patents
A kind of polymer waterborne gel and its preparation method and application Download PDFInfo
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- CN108158978A CN108158978A CN201810252316.8A CN201810252316A CN108158978A CN 108158978 A CN108158978 A CN 108158978A CN 201810252316 A CN201810252316 A CN 201810252316A CN 108158978 A CN108158978 A CN 108158978A
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- polymer waterborne
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- allergic rhinitis
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- 229920000642 polymer Polymers 0.000 title claims abstract description 53
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims abstract description 54
- 206010039085 Rhinitis allergic Diseases 0.000 claims abstract description 32
- 201000010105 allergic rhinitis Diseases 0.000 claims abstract description 32
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 28
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 22
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims abstract description 15
- 239000000463 material Substances 0.000 claims abstract description 15
- 239000008213 purified water Substances 0.000 claims abstract description 15
- 229920002125 Sokalan® Polymers 0.000 claims abstract description 14
- 229960001631 carbomer Drugs 0.000 claims abstract description 14
- 230000002265 prevention Effects 0.000 claims abstract description 13
- 235000011187 glycerol Nutrition 0.000 claims abstract description 11
- 229920000136 polysorbate Polymers 0.000 claims abstract description 9
- 229950008882 polysorbate Drugs 0.000 claims abstract description 9
- 239000000499 gel Substances 0.000 claims abstract 18
- 238000003756 stirring Methods 0.000 claims description 22
- 239000002994 raw material Substances 0.000 claims description 16
- 230000008961 swelling Effects 0.000 claims description 10
- 238000010438 heat treatment Methods 0.000 claims description 9
- 238000004945 emulsification Methods 0.000 claims description 7
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 7
- 229920000053 polysorbate 80 Polymers 0.000 claims description 7
- 238000001816 cooling Methods 0.000 claims description 3
- 229960005150 glycerol Drugs 0.000 claims description 3
- 238000002156 mixing Methods 0.000 claims description 3
- 238000005303 weighing Methods 0.000 claims description 3
- 230000000694 effects Effects 0.000 abstract description 18
- 238000012360 testing method Methods 0.000 abstract description 14
- 239000000084 colloidal system Substances 0.000 abstract description 8
- 239000012535 impurity Substances 0.000 abstract description 8
- 230000001788 irregular Effects 0.000 abstract description 8
- 244000005700 microbiome Species 0.000 abstract description 8
- 238000009098 adjuvant therapy Methods 0.000 abstract description 7
- 239000000047 product Substances 0.000 description 40
- 239000003814 drug Substances 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 230000009967 tasteless effect Effects 0.000 description 6
- 241000238740 Dermatophagoides pteronyssinus Species 0.000 description 5
- 238000010521 absorption reaction Methods 0.000 description 5
- 239000000428 dust Substances 0.000 description 5
- 229920002521 macromolecule Polymers 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 210000003928 nasal cavity Anatomy 0.000 description 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 4
- 238000000034 method Methods 0.000 description 3
- NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 description 2
- 206010020751 Hypersensitivity Diseases 0.000 description 2
- 208000036071 Rhinorrhea Diseases 0.000 description 2
- 206010039101 Rhinorrhoea Diseases 0.000 description 2
- 206010070834 Sensitisation Diseases 0.000 description 2
- 230000000172 allergic effect Effects 0.000 description 2
- 208000010668 atopic eczema Diseases 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000003349 gelling agent Substances 0.000 description 2
- 239000003292 glue Substances 0.000 description 2
- 230000001939 inductive effect Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 210000001331 nose Anatomy 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 206010039083 rhinitis Diseases 0.000 description 2
- 230000008313 sensitization Effects 0.000 description 2
- 235000011121 sodium hydroxide Nutrition 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 1
- ATVJXMYDOSMEPO-UHFFFAOYSA-N 3-prop-2-enoxyprop-1-ene Chemical compound C=CCOCC=C ATVJXMYDOSMEPO-UHFFFAOYSA-N 0.000 description 1
- 244000144725 Amygdalus communis Species 0.000 description 1
- 235000011437 Amygdalus communis Nutrition 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 240000005528 Arctium lappa Species 0.000 description 1
- 235000003130 Arctium lappa Nutrition 0.000 description 1
- 241001645380 Bassia scoparia Species 0.000 description 1
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 description 1
- 235000007516 Chrysanthemum Nutrition 0.000 description 1
- 244000189548 Chrysanthemum x morifolium Species 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 241001465251 Ephedra sinica Species 0.000 description 1
- 240000004670 Glycyrrhiza echinata Species 0.000 description 1
- 235000001453 Glycyrrhiza echinata Nutrition 0.000 description 1
- 235000006200 Glycyrrhiza glabra Nutrition 0.000 description 1
- 235000017382 Glycyrrhiza lepidota Nutrition 0.000 description 1
- 108060003951 Immunoglobulin Proteins 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 241001521901 Tribulus lanuginosus Species 0.000 description 1
- 241001643642 Viticis Species 0.000 description 1
- 241001251949 Xanthium sibiricum Species 0.000 description 1
- 244000126002 Ziziphus vulgaris Species 0.000 description 1
- 239000013566 allergen Substances 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 208000030961 allergic reaction Diseases 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 229940086737 allyl sucrose Drugs 0.000 description 1
- 235000020224 almond Nutrition 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000036783 anaphylactic response Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 238000007405 data analysis Methods 0.000 description 1
- 238000004925 denaturation Methods 0.000 description 1
- 230000036425 denaturation Effects 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 230000009881 electrostatic interaction Effects 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 238000001879 gelation Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 229910052602 gypsum Inorganic materials 0.000 description 1
- 239000010440 gypsum Substances 0.000 description 1
- 229960001340 histamine Drugs 0.000 description 1
- 238000005213 imbibition Methods 0.000 description 1
- 102000018358 immunoglobulin Human genes 0.000 description 1
- 238000009169 immunotherapy Methods 0.000 description 1
- 229940010454 licorice Drugs 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000003020 moisturizing effect Effects 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 210000003097 mucus Anatomy 0.000 description 1
- 210000002850 nasal mucosa Anatomy 0.000 description 1
- 229920001206 natural gum Polymers 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- WXZMFSXDPGVJKK-UHFFFAOYSA-N pentaerythritol Chemical compound OCC(CO)(CO)CO WXZMFSXDPGVJKK-UHFFFAOYSA-N 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 229940124531 pharmaceutical excipient Drugs 0.000 description 1
- 239000011164 primary particle Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 206010041232 sneezing Diseases 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
Classifications
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Otolaryngology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of polymer waterborne gels and its preparation method and application, and using carbomer as gel material, combination purified water, glycerine, polysorbate adjust pH using NaOH solution, electronegative gelinite are prepared.Polymer waterborne gel of the present invention is non-stimulated, it is transparent, there is irregular bubble, without other any macroscopic exogenous impurities, in sticky shape colloid, free from extraneous odour, pH=6.30 9.37, dynamic viscosity is 5000 7000mPa.s, content of microorganisms is 10cfu/g, its in clinical test is to Allergic Rhinitis total effective rate up to 90% or so, and the similar product of the listing of control group smear must be net effective percentage be no more than 70%, show that polymer waterborne gel for treating allergic rhinitis of the present invention is better than other similar products, there are preferable prevention and adjuvant treatment effect to allergic rhinitis.
Description
Technical field
The present invention relates to aqueous gel field, especially a kind of polymer waterborne gel and its preparation method and application.
Background technology
Allergic rhinitis (allergic rhinitis, AR) is also known as allergic rhinitis, refers to schneiderian membrance dust exposure mite
Or after the anaphylactogens such as dermatophagoides pteronyssinus, immunoglobulin E (IgE) is generated, and adsorb on basicyte surface, make body sensitization.When
After being contacted again same allergin, anaphylactogen and IgE are combined, and have activated the enzyme in basicyte, release histamine, slow anti-
Answer the media such as substance, and show as that schneiderian membrane is pale, oedema, intranasal a large amount of clear nasal mucus retain, rhiocnesmus, sneezing, rhinorrhea etc.
Clinical symptoms.The treatment of allergic rhinitis is mainly used and is detached from the therapies such as sensibiligen drug, specific active immunotherapy.
Chinese invention patent CN101953949B discloses a kind of Chinese medicine composition for treating allergic rhinitis, the Chinese medicine group
Object is closed to be made of the following raw material medicine：It is caulis perllae, great burdock achene, chrysanthemum, the fruit of summer cypress, tribulus terrestris, almond, gypsum, the achene of Siberian cocklebur, pungent
Sprout, fructus viticis, dark plum, licorice, jujube, Chinese ephedra processed, above-mentioned composition add in pharmaceutical excipients after the extraction of conventional process
Capsule, tablet, granule, gelling agent or oral liquid is made.It occur frequently that patient goes out certain traditional Chinese medicinal components allergy in use
The in-and-out situation of the existing state of an illness, gelling agent made of Chinese medicine composition is quick to certain patients sometimes, to other patients then
The benefiting from property for not having the effect of apparent namely product is limited.
Invention content
Problem to be solved by this invention is to overcome the shortcomings of the prior art, provide a kind of polymer waterborne gel and
Preparation method and use.
Polymer waterborne gel of the present invention is applied in nasal cavity, is soaked nasal cavity, is easily formed continuous film, pass through electrostatic
Interaction by the absorption of the Typical allergics such as the dust mite with charge or dermatophagoides pteronyssinus original on gel mucous membrane, reduces it into nose
Chamber inducing specific IgE antibody reacts, so as to play the role of prevention and auxiliary treatment to allergic rhinitis.Meanwhile this
The invention polymer waterborne gel does not contain traditional Chinese medicinal components, has prevented the situation of certain traditional Chinese medicinal components sensitization from source,
The tolerance of product is improved, different patients is greatly reduced and is happened using what rear effect differed, ensure that therapeutic effect
Generality.
The present invention prepares gel to play Electrostatic Absorption effect with carbomer, and carbomer prepares gel and is easily mixed not
Uniform situation causes distribution of charges uneven, weakens using effect, it is unstable drug effect occur；The present invention is asked to solve this
Topic using vacuum condition, carries out homogeneous to sample, high speed shear is realized, so as to form the uniform gelinite of distribution of charges.
Polymer waterborne gel of the present invention is the materials such as combination purified water, glycerine using carbomer as gel material,
PH is adjusted using NaOH solution, electronegative gelinite is prepared, is semisolid preparation.Gel products contain 90% or so water
Point, it is a kind of polymer waterborne gel similar to vital tissues, keeps sticky glue at normal temperatures, not dry or liquefaction；Energy
The protective film of continuous-stable is formed, free gas is allowed to permeate, metabolite can be discharged by gel networks, permeability
By force；Adsorption area is big, can adsorb dust mite positively charged in home life, dermatophagoides pteronyssinus particle.
Each component effect is as follows in the present invention：
1., glycerine, the entitled glycerine of chemistry is pleasantly sweet, is water white transparency viscous liquid, has good water imbibition, can inhale
The moisture in air is received, for moisturizing in affected part, and keeps the moisture of skin surface.
2., carbomer, the high molecular polymer of allyl sucrose or pentaerythrite allyl ether is bonded for acrylic acid, is contained
56.0%~68.0% carboxyl (- COOH).Carbomer is a kind of multiduty pharmaceutic adjuvant, and loaded United States Pharmacopeia is chemical
Property is stablized, and no allergic reaction is widely used in Pharmaceutical study.CMC, natural gum class than other gel-type vehicles
On feel is used and product clarity has greater advantage.Acritamer 940 dosage property is stablized, safe and non-toxic, has short stream
The features such as denaturation, high viscosity, product property stability.
3., polysorbate, full name is polyoxyethylene sorbitan monooleate, nonionic surface active agent；It is readily soluble
Yu Shui has emulsification and peptizaiton, improves the homogeneity and stability of product.
4., sodium hydroxide, highly basic, be made into aqueous solution adjust gel acid-base property, make gelinite negatively charged, play absorption
Function.
In the present invention, the dynamic viscosity of polymer waterborne gel is affected to the using effect of product, due to the present invention
The polymer waterborne gel is directly to be applied in nasal cavity, common by dust mite of the absorption with charge or dermatophagoides pteronyssinus etc.
Allergen particles reduce it and react into nasal cavity inducing specific IgE antibody, so as to allergic rhinitis play prevention and
The effect of auxiliary treatment, when 25 DEG C of dynamic viscosities be less than 5000Pa.s, it is impossible to effectively absorption with charge dust mite or
The Typical allergics primary particle such as dermatophagoides pteronyssinus, when 25 DEG C of dynamic viscosities are higher than 7000mPa.s, smearing is difficult, influences user experience.
Concrete scheme is as follows：
A kind of polymer waterborne gel, the polymer waterborne gel are 5000- in 25 DEG C of dynamic viscosity
7000mPa.s, pH 6.30-9.37 are prepared by weight by following raw material：
Further, polymer waterborne gel is prepared by weight by following raw material：
Further, polymer waterborne gel is prepared by weight by following raw material：
Further, the carbomer is Acritamer 940, meets pharmacopoeial requirements；
Optional, the polysorbate is Tween-80；
Optional, the purified water meets the medicinal water regulation of pharmacopeia, sterile, 5.1 μ s/cm of conductivity ＜ at 25 DEG C.
The present invention also provides the purposes of the polymer waterborne gel, are controlled for the prevention or auxiliary of allergic rhinitis
It treats.
The present invention also provides the preparation methods of the polymer waterborne gel, include the following steps：1. by the weight
Amount part weighs each raw material, carbomer, glycerine, polysorbate is poured into agitated kettle, turn on agitator, adds in 80% volume
Purified water, capping stir evenly, for lower step；
2. upper step material is put into homogenizer, homogeneous after ten minutes, opens scraper agitator and vacuum system, stirring motor
Frequency 20Hz when vacuum degree reaches -0.05MPa in pot, closes vacuum system, stirs evenly swelling and obtains within 24 hours swelling material；
3. the purified water of NaOH and remaining 20% volume is dissolved in kettle, heating obtains NaOH solution；
4. 2. swelling material that step is obtained adds in emulsification pot, homogenizer, 3. NaOH that step is obtained are opened in heating
Solution is added in emulsification pot, is added rear homogeneous 5min, is stirred evenly later；
5. opening jacketed valve door, lead in chuck and cool down water cooling, when the temperature in pot to be emulsified reaches 45 DEG C, gel system
It is standby to finish, stop scraper plate stirring, Open valve makes pot inner pressure restore normal, pours out material to get the polymer waterborne
Gel.
Further, the step 1. in, the stirring frequency of blender is 35Hz, and mixing time is 15 minutes.
Further, the step 3. middle heating temperature be 80 DEG C；
Optional, the temperature of the step 4. middle heating is 80 DEG C, and the frequency of stirring is 35Hz, and the time of stirring is
30min。
The present invention also protects the polymer waterborne gel that the preparation method of the polymer waterborne gel obtains.
The present invention also protects the purposes of the polymer waterborne gel, is controlled for the prevention or auxiliary of allergic rhinitis
It treats.
Advantageous effect：Polymer waterborne gel tasteless and nonirritant of the present invention, it is transparent, have irregular bubble, nothing
Other any macroscopic exogenous impurities, in sticky shape colloid, free from extraneous odour, pH=6.30-9.37, dynamic viscosity 5000-
7000mPa.s, content of microorganisms 10cfu/g meet requirement, and polymer waterborne of the present invention coagulates in clinical test
Glue to Allergic Rhinitis total effective rate up to 90% or so, and the similar product of the listing of control group smear must be net effective percentage
No more than 70%, show polymer waterborne gel for treating allergic rhinitis of the present invention better than other similar products, to mistake
Quick property rhinitis has preferable prevention and adjuvant treatment effect.
Specific embodiment
Technical solution of the present invention is further elaborated with reference to embodiment.Particular technique or item are not specified in embodiment
Part person carries out according to the described technology of document in the art or condition or according to product description.Agents useful for same or instrument
Production firm person is not specified in device, and being can be with conventional products that are commercially available.
In this implementation, carbomer is Acritamer 940, meets pharmacopoeial requirements, and polysorbate is Tween-80；Purified water
Meet pharmacopeia medicinal water regulation, sterile, 5.1 μ s/cm of conductivity ＜ at 25 DEG C.
Embodiment 1
Polymer waterborne gel is prepared according to following steps：
1. weighing each raw material by table 1, carbomer, glycerine, polysorbate are poured into agitated kettle, turn on agitator adds
Enter the purified water of 80% volume, capping stirs evenly, for lower step；
2. upper step material is put into homogenizer, homogeneous after ten minutes, opens scraper agitator and vacuum system, stirring motor
Frequency 20Hz when vacuum degree reaches -0.05MPa in pot, closes vacuum system, stirs evenly swelling and obtains within 24 hours swelling material；
3. the purified water of NaOH and remaining 20% volume is dissolved in kettle, it is heated to 80 DEG C and obtains NaOH solution；
4. 2. swelling material that step is obtained adds in emulsification pot, heating, it is 80 DEG C to treat temperature, opens homogenizer, will walk
The rapid NaOH solution 3. obtained is added in emulsification pot, adds rear homogeneous 5min, opens stirring, and stirring frequency 35Hz is maintained
30min；
5. opening jacketed valve door, lead in chuck and cool down water cooling, when the temperature in pot to be emulsified reaches 45 DEG C, gel system
It is standby to finish, stop scraper plate stirring, Open valve makes pot inner pressure restore normal, pours out material to get the polymer waterborne
Gel is sent after weighing to embedding process.
1 raw material dosage table (parts by weight) of table
The polymer waterborne gel that embodiment 1 obtains is detected, the results are shown in Table 2, from table 2 it can be seen that product without
It is taste, non-stimulated, it is transparent, have irregular bubble, without other any macroscopic exogenous impurities, in sticky shape colloid, it is no different
Taste, pH=6.4, dynamic viscosity 6276mPa.s, content of microorganisms 10cfu/g meet requirement.
2 testing result table of table
The product that embodiment 1 is obtained is used for clinical test, and the attached people of Fujian University of Traditional Chinese Medicine are chosen in this clinical test
Hospital is total to 72 allergic rhinitis subjects of enrolled subject, test group and each 36 of control group, and wherein test group uses implementation
The polymer waterborne gel that example 1 obtains, control group is smeared using the similar product of listing must be net.Usage is three times per day, uses every time
0.5g is measured, is uniformly applied to around prenaris.All selected cases meet inclusion criteria, do not meet the feelings of exclusion criteria
Condition.Test group comes off 2, and control group comes off 3, remaining selected case complete testing program defined requirement with
It visits, data are effective, for clinical data analysis.
In clinical test, after the polymer waterborne gel obtained using embodiment 1, sneeze, runny nose, nose are significantly improved
Plug, rhiocnesmus, concha swelling degree, the effect of passing through follow-up score analysis, total effective rate is up to 88.8%；The listing of control group
The effective percentage that similar product smears must be net is 69.4%, and the two is for statistical analysis, has statistical significance, it was demonstrated that embodiment 1 obtains
The polymer waterborne gel for treating allergic rhinitis obtained is better than other similar products.
Embodiment 2
Raw material dosage is shown in Table 1, and preparation method is with implementing 1, obtained product tasteless and nonirritant, it is transparent, have it is irregular
Bubble, without other any macroscopic exogenous impurities, in sticky shape colloid, free from extraneous odour, pH=6.8, dynamic viscosity is
6064mPa.s, content of microorganisms 10cfu/g meet requirement, the polymer waterborne that the present embodiment obtains in clinical test
Gel to Allergic Rhinitis total effective rate 86.11%, and the similar product of the listing of control group smear must be net effective percentage
66.6%, show polymer waterborne gel for treating allergic rhinitis of the present invention better than other similar products, to anaphylaxis
Rhinitis has preferable prevention and adjuvant treatment effect.
Embodiment 3
Raw material dosage is shown in Table 1, and preparation method is with implementing 1, obtained product tasteless and nonirritant, it is transparent, have it is irregular
Bubble, without other any macroscopic exogenous impurities, in sticky shape colloid, free from extraneous odour, pH=7.2, dynamic viscosity is
6462mPa.s, content of microorganisms 10cfu/g meet requirement, the macromolecule water that the present embodiment is obtained in clinical test
Property gel is to Allergic Rhinitis total effective rate up to 90% or so, and the similar product of the listing of control group is smeared and must be had only
Efficiency is no more than 70%, shows that polymer waterborne gel for treating allergic rhinitis of the present invention is better than other similar products,
There are preferable prevention and adjuvant treatment effect to allergic rhinitis.
Embodiment 4
Raw material dosage is shown in Table 1, and preparation method is with implementing 1, obtained product tasteless and nonirritant, it is transparent, have it is irregular
Bubble, without other any macroscopic exogenous impurities, in sticky shape colloid, free from extraneous odour, pH=8.4, dynamic viscosity is
5371mPa.s, content of microorganisms 10cfu/g meet requirement, the macromolecule water that the present embodiment is obtained in clinical test
Property gel is to Allergic Rhinitis total effective rate up to 90% or so, and the similar product of the listing of control group is smeared and must be had only
Efficiency is no more than 70%, shows that polymer waterborne gel for treating allergic rhinitis of the present invention is better than other similar products,
There are preferable prevention and adjuvant treatment effect to allergic rhinitis.
Embodiment 5
Raw material dosage is shown in Table 1, and preparation method is with implementing 1, obtained product tasteless and nonirritant, it is transparent, have it is irregular
Bubble, without other any macroscopic exogenous impurities, in sticky shape colloid, free from extraneous odour, pH=7.8, dynamic viscosity is
6817mPa.s, content of microorganisms 10cfu/g meet requirement, the macromolecule water that the present embodiment is obtained in clinical test
Property gel is to Allergic Rhinitis total effective rate up to 90% or so, and the similar product of the listing of control group is smeared and must be had only
Efficiency is no more than 70%, shows that polymer waterborne gel for treating allergic rhinitis of the present invention is better than other similar products,
There are preferable prevention and adjuvant treatment effect to allergic rhinitis.
Embodiment 6
Raw material dosage is shown in Table 1, and preparation method is with implementing 1, obtained product tasteless and nonirritant, it is transparent, have it is irregular
Bubble, without other any macroscopic exogenous impurities, in sticky shape colloid, free from extraneous odour, pH=9.1, dynamic viscosity is
5045mPa.s, content of microorganisms 10cfu/g meet requirement, the macromolecule water that the present embodiment is obtained in clinical test
Property gel is to Allergic Rhinitis total effective rate up to 90% or so, and the similar product of the listing of control group is smeared and must be had only
Efficiency is no more than 70%, shows that polymer waterborne gel for treating allergic rhinitis of the present invention is better than other similar products,
There are preferable prevention and adjuvant treatment effect to allergic rhinitis.
Embodiment 7
The dosage of fixed purified water, glycerine, Polyoxyethylene Sorbitan Monooleate and NaOH, change Acritamer 940 dosage, study card wave
Influence of 940 dosage of nurse (parts by weight) to product viscosity, specifically, the use of purified water, glycerine, Polyoxyethylene Sorbitan Monooleate and NaOH
For amount with embodiment 1, the dosage of Acritamer 940 is shown in Table 3.
Influence (25 DEG C) of the 3 Acritamer 940 dosage (parts by weight) of table to product viscosity
| Acritamer 940 dosage | 0.8 | 0.9 | 1.0 | 2.0 | 3.0 | 4.0 | 5.0 |
| Dynamic viscosity mPa.s | 5154 | 5435 | 6276 | 6165 | 6349 | 6537 | 6876 |
From table 3 it can be seen that the dosage of carbomer influences significantly, with card wave the dynamic viscosity of polymer waterborne gel
The dosage of nurse increases, and dynamic viscosity is in increase tendency, and the dosage of carbomer can reach high score in 0.8-5.0 parts by weight section
The dynamic viscosity (25 DEG C) of sub- aqueous gel is in the effect of 5000-7000mPa.s, and less than 0.8 parts by weight or higher than 5.0 weight
Part, then product dynamic viscosity off-target range, and then using effect can be weakened.
Embodiment 8
The dosage of fixed purified water, glycerine, Polyoxyethylene Sorbitan Monooleate and Acritamer 940, changes NaOH dosages, and research is different
Influence namely pH influence to product viscosity of the NaOH dosages to product viscosity, specifically, purified water, glycerine, polysorbate
The dosage of ester -80 and Acritamer 940 adjusts NaOH dosages to reach product pH situations in table 4 with embodiment 1.
Influences (25 DEG C) of the table 4pH to product dynamic viscosity
| pH | 4.12 | 5.07 | 6.30 | 7.07 | 8.21 | 9.37 | 9.52 |
| Dynamic viscosity mPa.s | 4274 | 4974 | 6231 | 6960 | 5516 | 5170 | 4210 |
From table 4, it can be seen that under the conditions of mixture ratios of the present embodiment, when pH is 6.30-9.37, product dynamic viscosity
(25 DEG C) are 5170-6960mPa.s, meet the optimum viscosity range of product, in the range of this pH, corresponding NaOH amount ranges
For 0.1-0.6 parts by weight.
Although the embodiments of the present invention has been shown and described above, it is to be understood that above-described embodiment is example
Property, it is impossible to limitation of the present invention is interpreted as, those of ordinary skill in the art are not departing from the principle of the present invention and objective
In the case of can make changes, modifications, substitutions and variations to the above described embodiments within the scope of the invention.
Claims (10)
1. a kind of polymer waterborne gel, it is characterised in that：The polymer waterborne gel is in 25 DEG C of dynamic viscosity
5000-7000mPa.s, pH 6.30-9.37 are prepared by weight by following raw material：
2. polymer waterborne gel according to claim 1, it is characterised in that：It is prepared by weight by following raw material
It arrives：
3. polymer waterborne gel according to claim 1, it is characterised in that：It is prepared by weight by following raw material
It arrives：
4. according to claim 1-3 any one of them polymer waterborne gels, it is characterised in that：The carbomer is card wave
Nurse 940, meets pharmacopoeial requirements；
Optional, the polysorbate is Tween-80；
Optional, the purified water meets the medicinal water regulation of pharmacopeia, sterile, 5.1 μ s/cm of conductivity ＜ at 25 DEG C.
5. the purposes of the polymer waterborne gel described in any one of claim 1-3, for the prevention of allergic rhinitis or auxiliary
Help treatment.
6. the preparation method of claim 1-3 any one of them polymer waterborne gels, it is characterised in that：Including following step
Suddenly：1. weighing each raw material by claim 1-3 any one of them parts by weight, carbomer, glycerine, polysorbate are poured into and stirred
It mixes in pot, turn on agitator, adds in the purified water of 80% volume, capping stirs evenly, for lower step；
2. upper step material is put into homogenizer, homogeneous after ten minutes, opens scraper agitator and vacuum system, stirring motor frequency
20Hz when vacuum degree reaches -0.05MPa in pot, closes vacuum system, stirs evenly swelling and obtains within 24 hours swelling material；
3. the purified water of NaOH and remaining 20% volume is dissolved in kettle, heating obtains NaOH solution；
4. 2. swelling material that step is obtained adds in emulsification pot, homogenizer, 3. NaOH solution that step is obtained are opened in heating
It adds in emulsification pot, adds rear homogeneous 5min, stir evenly later；
5. opening jacketed valve door, lead in chuck and cool down water cooling, when the temperature in pot to be emulsified reaches 45 DEG C, prepared by gel
Finish, stop scraper plate stirring, Open valve makes pot inner pressure restore normal, pours out material to get the polymer waterborne gel.
7. the preparation method of polymer waterborne gel according to claim 6, it is characterised in that：The step 1. in, stir
The stirring frequency for mixing device is 35Hz, and mixing time is 15 minutes.
8. the preparation method of polymer waterborne gel according to claim 6, it is characterised in that：The step 3. middle heating
Temperature be 80 DEG C；
Optional, the temperature of the step 4. middle heating is 80 DEG C, and the frequency of stirring is 35Hz, and the time of stirring is 30min.
9. the polymer waterborne gel that the preparation method of the polymer waterborne gel described in any one of claim 6-8 obtains.
10. the purposes of the polymer waterborne gel described in claim 9, prevention or auxiliary treatment for allergic rhinitis.
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Citations (4)
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|---|---|---|---|---|
| CN1216464A (en) * | 1996-02-27 | 1999-05-12 | 帝人株式会社 | Powdery composition for nasal administration |
| CN101590074A (en) * | 2008-05-27 | 2009-12-02 | 郭进军 | The purposes of carbomer gel on the Polyglucan rhinitis |
| CN103142461A (en) * | 2013-01-25 | 2013-06-12 | 中国人民解放军军事医学科学院微生物流行病研究所 | Gel for vaginas and preparation method thereof |
| WO2017021816A1 (en) * | 2015-07-31 | 2017-02-09 | Metis Healthcare S.R.L. | Composition for the increase of humoral secretion |
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2018
- 2018-03-26 CN CN201810252316.8A patent/CN108158978A/en active Pending
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|---|---|---|---|---|
| CN1216464A (en) * | 1996-02-27 | 1999-05-12 | 帝人株式会社 | Powdery composition for nasal administration |
| CN101590074A (en) * | 2008-05-27 | 2009-12-02 | 郭进军 | The purposes of carbomer gel on the Polyglucan rhinitis |
| CN103142461A (en) * | 2013-01-25 | 2013-06-12 | 中国人民解放军军事医学科学院微生物流行病研究所 | Gel for vaginas and preparation method thereof |
| WO2017021816A1 (en) * | 2015-07-31 | 2017-02-09 | Metis Healthcare S.R.L. | Composition for the increase of humoral secretion |
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