CN117257724A - Gel dressing and preparation method and application thereof - Google Patents
Gel dressing and preparation method and application thereof Download PDFInfo
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- CN117257724A CN117257724A CN202311314739.5A CN202311314739A CN117257724A CN 117257724 A CN117257724 A CN 117257724A CN 202311314739 A CN202311314739 A CN 202311314739A CN 117257724 A CN117257724 A CN 117257724A
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- 238000002360 preparation method Methods 0.000 title claims abstract description 30
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract description 102
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 85
- 239000008213 purified water Substances 0.000 claims abstract description 48
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 48
- 239000011159 matrix material Substances 0.000 claims abstract description 45
- 235000021255 galacto-oligosaccharides Nutrition 0.000 claims abstract description 32
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims abstract description 31
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 30
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 claims abstract description 30
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 claims abstract description 30
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- 229940043234 carbomer-940 Drugs 0.000 claims description 8
- JVTIXNMXDLQEJE-UHFFFAOYSA-N 2-decanoyloxypropyl decanoate 2-octanoyloxypropyl octanoate Chemical compound C(CCCCCCC)(=O)OCC(C)OC(CCCCCCC)=O.C(=O)(CCCCCCCCC)OCC(C)OC(=O)CCCCCCCCC JVTIXNMXDLQEJE-UHFFFAOYSA-N 0.000 claims description 4
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- WQZGKKKJIJFFOK-SVZMEOIVSA-N (+)-Galactose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-SVZMEOIVSA-N 0.000 description 2
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- VYZAHLCBVHPDDF-UHFFFAOYSA-N Dinitrochlorobenzene Chemical compound [O-][N+](=O)C1=CC=C(Cl)C([N+]([O-])=O)=C1 VYZAHLCBVHPDDF-UHFFFAOYSA-N 0.000 description 1
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- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 1
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- 208000006374 Uterine Cervicitis Diseases 0.000 description 1
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- GYCKQBWUSACYIF-UHFFFAOYSA-N o-hydroxybenzoic acid ethyl ester Natural products CCOC(=O)C1=CC=CC=C1O GYCKQBWUSACYIF-UHFFFAOYSA-N 0.000 description 1
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- OQUKIQWCVTZJAF-UHFFFAOYSA-N phenol;sulfuric acid Chemical compound OS(O)(=O)=O.OC1=CC=CC=C1 OQUKIQWCVTZJAF-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- 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
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Reproductive Health (AREA)
- Endocrinology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Gynecology & Obstetrics (AREA)
- Molecular Biology (AREA)
- Virology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Urology & Nephrology (AREA)
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- Medicinal Preparation (AREA)
Abstract
The invention relates to the technical field of gel dressing, in particular to a gel dressing and a preparation method and application thereof. The invention provides a gel dressing, which comprises the following components in percentage by mass: 1 to 5 percent of anti-HPV active component, 1 to 5 percent of gel matrix, 1 to 15 percent of glycerol, 0.1 to 15 percent of propylene glycol, 0.1 to 15 percent of absolute ethyl alcohol, 1 to 5 percent of triethanolamine, 0.01 to 0.5 percent of ethylparaben and the balance of purified water; the anti-HPV active component comprises a mixture of galactooligosaccharide and fucan or galactooligosaccharide. The gel dressing can effectively prevent and treat HPV, has no irritation to vagina and skin, and is safe to use.
Description
Technical Field
The invention relates to the technical field of gel dressing, in particular to a gel dressing and a preparation method and application thereof.
Background
Gynecological diseases caused by viruses are most commonly infected by Human Papilloma Virus (HPV), herpes Simplex Virus (HSV) and other viruses. Cervical cancer is one of four malignant tumors of women worldwide, and the death rate is the second most serious cancer among women, and the cervical cancer has a younger trend in the day before. Cervical cancer is a representative of diseases associated with HPV infection, and almost all cervical cancer patients can detect HPV infection, and long-term infection of HPV is closely related to cervical pain and precancerous lesions.
At present, the treatment methods of gynecological diseases caused by pathogenic microorganisms are mainly physiotherapy and pharmacotherapy. Physical therapy is prone to cause destruction of epithelial cells; the oral drug treatment has the limitation of single problems of drug resistance, side effect and action links and the like. Because the vagina has abundant capillaries and lymphatic vessels and no definite nerve endings, the pain stimulation of patients is small when the medicine is administrated, and the medicine can be placed in the vagina and absorbed into local or whole body blood circulation through vaginal mucosa to achieve the treatment purpose. At present, although application research of the gel agent is widely focused by scholars at home and abroad, effective gel agent research aiming at gynecological diseases of HPV infection is less, and development of a gel agent which is free of irritation, safe to use and good in effect and is resistant to HPV infection is urgently needed.
Disclosure of Invention
The invention aims to provide a gel dressing, a preparation method and application thereof, wherein the gel dressing takes an anti-HPV active component as a main active component, the anti-HPV active component comprises a mixture of oligomeric galactosan sulfate and fucoidan or oligomeric galactosan sulfate, the gel dressing can effectively prevent and treat HPV, has no irritation to vagina and skin, and is safe to use.
In order to achieve the above object, the present invention provides the following technical solutions:
the invention provides a gel dressing, which comprises the following components in percentage by mass: 1 to 5 percent of anti-HPV active component, 1 to 5 percent of gel matrix, 1 to 15 percent of glycerol, 0.1 to 15 percent of propylene glycol, 0.1 to 15 percent of absolute ethyl alcohol, 1 to 5 percent of triethanolamine, 0.01 to 0.5 percent of ethylparaben and the balance of purified water;
the anti-HPV active component comprises a mixture of galactooligosaccharide and fucan or galactooligosaccharide.
Preferably, the composition comprises the following components in percentage by mass: 2 to 3 percent of anti-HPV active component, 2 to 5 percent of gel matrix, 1 to 10 percent of glycerol, 1 to 9 percent of propylene glycol, 1 to 11 percent of absolute ethyl alcohol, 1 to 5 percent of triethanolamine, 0.1 to 0.4 percent of ethylparaben and the balance of purified water.
Preferably, the gel matrix is one or more of carbomer 940, carbomer 941, carbomer 934 and sodium carboxymethyl cellulose.
Preferably, when the anti-HPV active component comprises a mixture of galactooligosaccharide and fucan, the mass ratio of galactooligosaccharide to fucan is (1-10): 1.
preferably, the oligomeric galactosan comprises a compound with a structure shown in a formula 1 and a compound with a structure shown in a formula 2; wherein the weight percentage of the compound with the structure shown in the formula 1 in the oligomeric sulfuric acid galactan is 5-50%, and the weight percentage of the compound with the structure shown in the formula 2 in the oligomeric sulfuric acid galactan is 50-95%;
wherein in the formulas 1 and 2, R 1 、R 2 、R 3 Independently H or SO 3 - N is a positive integer of 15 to 100.
The invention also provides a preparation method of the gel dressing according to the technical scheme, which comprises the following steps:
after swelling the gel matrix by purified water, sequentially adding glycerol and triethanolamine to obtain a transparent gel matrix;
mixing the HPV-resistant active component with absolute ethyl alcohol to obtain a solution A;
and adding the solution A and the ethylparaben into the transparent gel matrix, and sequentially adding propylene glycol and purified water to obtain the gel dressing.
Preferably, the mass of the purified water used in the swelling treatment is 2 to 4 times the mass of the gel matrix.
Preferably, after the propylene glycol and the purified water are sequentially added, the method further comprises sequentially filling, capping and sterilizing;
the sterilization is damp-heat sterilization;
the sterilization temperature is 115 ℃ and the sterilization time is 30-40 min.
The invention also provides the application of the gel dressing in the technical scheme or the gel dressing prepared by the preparation method in the technical scheme in preparing an external preparation for treating and/or preventing HPV and gynecological diseases.
Preferably, the gynaecological disease is caused by a bacterial or viral infection.
The invention provides a gel dressing, which comprises the following components in percentage by mass: 1 to 5 percent of anti-HPV active component, 1 to 5 percent of gel matrix, 1 to 15 percent of glycerol, 0.1 to 15 percent of propylene glycol, 0.1 to 15 percent of absolute ethyl alcohol, 1 to 5 percent of triethanolamine, 0.01 to 0.5 percent of ethylparaben and the balance of purified water; the anti-HPV active component comprises a mixture of galactooligosaccharide and fucan or galactooligosaccharide.
Compared with the prior art, the technical scheme of the invention has the following beneficial effects:
1) The main active ingredients of the anti-HPV infection compound preparation comprise oligomeric galactosan, wherein the oligomeric galactosan has negative charges and can effectively neutralize and wrap positive charges carried by pathogenic microorganisms, so that a protective film is formed, HPV infection can be effectively prevented and treated, the negative conversion rate after 3 months is 92.31% -96.92%, the anti-HPV infection compound preparation has no irritation to vagina and skin, and the anti-HPV infection compound preparation is safe to use;
2) According to the invention, after fucoidan is used for replacing the galactooligosaccharide, the negative conversion rate is 72.31% after 3 months, and it can be seen that the anti-HPV effect of fucoidan used alone is lower than that of galactooligosaccharide used alone. The brown algae polysaccharide and the galactooligosaccharide sulfate are combined, the negative conversion rate of the prepared gel dressing after 3 months is 90.77-98.46%, and the combination of the brown algae polysaccharide and the galactooligosaccharide sulfate has a synergistic function;
3) The gel dressing can be used for pushing vagina in gynaecology or washing genital organs; can be used for treating low-grade cervical lesions (CIYI grade) caused by genital tract high-risk HPV infection; can be used for blocking genital tract HPV infection and preventing cervical precancerous lesions (CIN) and cervical cancer; improving vagina microenvironment, reducing vagina inflammatory reaction, reducing vagina secretion amount, effectively improving vagina cleanliness and reducing vagina pH value; can be used for treating various cervicitis, vaginal congestion, increased secretion, odor and pruritus caused by colpitis.
The invention also provides a preparation method of the gel dressing according to the technical scheme, which comprises the following steps: after swelling the gel matrix by purified water, sequentially adding glycerol and triethanolamine to obtain a transparent gel matrix; mixing the HPV-resistant active component with absolute ethyl alcohol to obtain a solution A; and adding the solution A and the ethylparaben into the transparent gel matrix, and sequentially adding propylene glycol and purified water to obtain the gel dressing. The gel dressing provided by the invention has the advantages of simple preparation method, convenience in operation, low production cost and good market prospect.
Detailed Description
In order to make the purposes, technical solutions and some points of the embodiments of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with the detailed description of the present invention.
The invention provides a gel dressing, which comprises the following components in percentage by mass: 1 to 5 percent of anti-HPV active component, 1 to 5 percent of gel matrix, 1 to 15 percent of glycerol, 0.1 to 15 percent of propylene glycol, 0.1 to 15 percent of absolute ethyl alcohol, 1 to 5 percent of triethanolamine, 0.01 to 0.5 percent of ethylparaben and the balance of purified water;
the anti-HPV active component comprises a mixture of galactooligosaccharide and fucan or galactooligosaccharide.
In the present invention, all the preparation materials are commercially available products well known to those skilled in the art unless specified otherwise.
The gel dressing comprises 1-5% of anti-HPV active component, preferably 2-3% of anti-HPV active component by mass percent. In the present invention, the anti-HPV active component comprises a mixture of galactooligosaccharide and fucan or galactooligosaccharide. When the anti-HPV active component comprises a mixture of galactooligosaccharide and fucan, the mass ratio of the galactooligosaccharide to the fucan is (1-10): 1, more preferably (2 to 4): 1, more preferably 2:1. In the present invention, the galactooligosaccharide includes a compound having a structural unit represented by formula 1 and a compound having a structural unit represented by formula 2; the compound having the structural unit shown in formula 1 accounts for preferably 5-50% of the weight of the oligomeric galactosan sulfate, more preferably 10-40%, most preferably 20-30%; the compound with the structural unit shown in the formula 2 accounts for preferably 50-95% of the weight of the oligomeric galactosan sulfate, more preferably 60-90%, and most preferably 70-80%;
wherein R in formula 1 1 Is H or SO 3 - ，R 2 Is H or SO 3 - ，R 3 Is H or SO 3 - N is a positive integer of 15 to 100;
wherein R in formula 2 1 Is H or SO 3 - ，R 2 Is H or SO 3 - ，R 3 Is H or SO 3 - N is a positive integer of 15 to 100.
The gel dressing comprises 1-5% of gel matrix, preferably 2-5% of gel matrix. In the present invention, the gel matrix preferably comprises one or more of carbomer 940, carbomer 941, carbomer 934 and sodium carboxymethylcellulose; when the gel matrix is two or more of the above specific choices, the present invention does not have any particular limitation on the ratio of the above specific substances, and the above specific substances may be mixed in any ratio.
The gel dressing comprises 1-15% of glycerin, preferably 1-10% of glycerin and most preferably 3.0% of glycerin.
In the present invention, the glycerol acts as a moisture absorbent.
The gel dressing comprises 0.1-15% of propylene glycol, preferably 1-9% of propylene glycol, and more preferably 5-9% of propylene glycol.
In the invention, the propylene glycol acts as a dispersing agent and an antifreeze agent.
The gel dressing comprises 0.1-15% of absolute ethyl alcohol, preferably 1-11% of absolute ethyl alcohol, and more preferably 5-11% of absolute ethyl alcohol.
In the present invention, the absolute ethanol acts as a solvent.
The gel dressing comprises 1-5% of triethanolamine, preferably 3-5% of triethanolamine.
In the present invention, the triethanolamine functions as an emulsifier, a humectant, a thickener, and a pH adjuster.
The gel dressing comprises 0.01 to 0.5 percent of ethylparaben, preferably 0.1 to 0.4 percent of ethylparaben by mass percent.
In the present invention, the ethyl hydroxy benzoate acts as a preservative.
The gel dressing also comprises the balance of purified water in percentage by mass.
The invention also provides a preparation method of the gel dressing, which comprises the following steps:
after swelling the gel matrix by purified water, sequentially adding glycerol and triethanolamine to obtain a transparent gel matrix;
mixing the HPV-resistant active component with absolute ethyl alcohol to obtain a solution A;
and adding the solution A and the ethylparaben into the transparent gel matrix, and sequentially adding propylene glycol and purified water to obtain the gel dressing.
In the present invention, the swelling treatment is preferably performed by immersing in purified water, and the immersing is not particularly limited in the present invention, and the gel matrix may be sufficiently swelled in purified water by a process well known to those skilled in the art. In the present invention, the mass of the purified water used in the swelling treatment is preferably 2 to 4 times the mass of the gel matrix, more preferably 3 times the mass of the gel matrix.
After the addition of the glycerin, the present invention also preferably includes stirring, and the stirring process is not particularly limited in the present invention, and may be performed by a process well known to those skilled in the art.
In the present invention, the triethanolamine is preferably added dropwise, and the process of adding dropwise is not particularly limited, and may be performed by a process known to those skilled in the art.
The preparation method of the invention also comprises the step of mixing the HPV-resistant active component with absolute ethyl alcohol to obtain a solution A.
The mixing process is not particularly limited, and may be performed by a process well known to those skilled in the art.
After the solution A is obtained, the solution A and the ethylparaben are added into the transparent gel matrix, and propylene glycol and purified water are sequentially added to obtain the gel dressing.
The method of adding the solution A and the ethylparaben is not particularly limited, and the method is carried out by adopting a process well known to a person skilled in the art. After the addition of the solution A and the ethylparaben is completed, stirring is also preferably included, and the stirring process is not particularly limited in the present invention, and may be performed by a process well known to those skilled in the art.
In the present invention, the process of adding the propylene glycol is preferably performed under stirring, and the stirring process is not particularly limited, and may be performed by a process well known to those skilled in the art.
After adding the purified water, the present invention also preferably includes stirring, and the stirring process is not particularly limited, and may be performed by a process well known to those skilled in the art.
After the propylene glycol and the purified water are added in sequence, the invention also preferably comprises canning, capping, sterilizing, cooling and packaging which are carried out in sequence; the process of canning, capping, cooling and packaging is not particularly limited, and may be performed by processes well known to those skilled in the art. In the invention, the sterilization temperature is preferably 115 ℃, and the sterilization time is preferably more than or equal to 30min. The sterilization mode is preferably damp heat sterilization.
In the present invention, the preparation process of the gel dressing is preferably carried out under the condition of room temperature (25 ℃) without additional heating and ultrasonic conditions.
The invention also provides application of the gel dressing in the technical scheme in preparing an external preparation for treating and/or preventing HPV and gynecological diseases.
In the present invention, the gynecological disease is preferably caused by bacterial or viral infection.
In the present invention, the virus is preferably human papilloma virus.
The gel dressing provided by the present invention, and the preparation method and application thereof are described in detail with reference to the following examples, but they should not be construed as limiting the scope of the present invention.
Example 1
The components of the gel dressing: galactooligosaccharide (comprising 25% by mass of a compound having a structural unit represented by formula 1 and 75% by mass of a compound having a structural unit represented by formula 2), 2% by mass of carbomer 9403%, glycerol 3%, propylene glycol 9%, absolute ethanol 11%, triethanolamine 3%, ethylparaben 0.1% and the balance purified water;
the preparation process comprises the following steps:
swelling carbomer 940 with 3 times of purified water, and sequentially adding glycerol and triethanolamine to obtain transparent gel matrix; mixing oligomeric galactosan sulfate and absolute ethyl alcohol to obtain a solution A; adding the solution A and the ethylparaben into the transparent gel matrix, stirring uniformly, gradually adding propylene glycol and stirring uniformly, adding purified water, stirring uniformly, canning, capping, sterilizing for 30min at 115 ℃ under damp heat, taking out, cooling, inspecting, packaging after passing, and obtaining the gel dressing (the color is colorless and transparent and meets the requirements).
Example 2
The components of the gel dressing: galactooligosaccharide (comprising 25% by mass of a compound having a structural unit represented by formula 1 and 75% by mass of a compound having a structural unit represented by formula 2) 2%, fucoidan 1%, carbomer 9403%, glycerol 3%, propylene glycol 9%, absolute ethanol 11%, triethanolamine 3%, ethylparaben 0.1% and the balance purified water;
the preparation process comprises the following steps:
swelling carbomer 940 with 3 times of purified water, and sequentially adding glycerol and triethanolamine to obtain transparent gel matrix; mixing oligomeric galactosan sulfate, fucoidan and absolute ethyl alcohol to obtain a solution A; adding the solution A and the ethylparaben into the transparent gel matrix, stirring uniformly, gradually adding propylene glycol and stirring uniformly, adding purified water, stirring uniformly, canning, capping, sterilizing for 30min at 115 ℃ under damp heat, taking out, cooling, inspecting, packaging after passing, and obtaining the gel dressing (the color is colorless and transparent and meets the requirements).
Example 3
The components of the gel dressing: 5% of galactooligosaccharide (comprising 25% of a compound with a structural unit shown in a formula 1 and 75% of a compound with a structural unit shown in a formula 2) by mass, 9405% of carbomer, 10% of glycerol, 5% of propylene glycol, 5% of absolute ethyl alcohol, 5% of triethanolamine, 0.4% of ethylparaben and the balance of purified water;
the preparation process comprises the following steps:
swelling sodium carboxymethylcellulose with 4 times of purified water, and sequentially adding glycerol and triethanolamine to obtain transparent gel matrix; mixing oligomeric galactosan sulfate and absolute ethyl alcohol to obtain a solution A; adding the solution A and the ethylparaben into the transparent gel matrix, stirring uniformly, gradually adding propylene glycol and stirring uniformly, adding purified water, stirring uniformly, canning, capping, sterilizing for 30min at 115 ℃ under damp heat, taking out, cooling, inspecting, packaging after passing, and obtaining the gel dressing (the color is colorless and transparent and meets the requirements).
Example 4
The components of the gel dressing: 1% of oligomeric galactosan sulfate (comprising 25% of a compound with a structural unit shown in a formula 1 and 75% of a compound with a structural unit shown in a formula 2 in percentage by mass), 9412% of carbomer, 1% of glycerol, 0.5% of propylene glycol, 8% of absolute ethyl alcohol, 1% of triethanolamine, 0.1% of ethylparaben and the balance of purified water;
the preparation process comprises the following steps:
swelling carbomer 941 with 2 times of purified water, and sequentially adding glycerol and triethanolamine to obtain transparent gel matrix; mixing oligomeric galactosan sulfate and absolute ethyl alcohol to obtain a solution A; adding the solution A and the ethylparaben into the transparent gel matrix, stirring uniformly, gradually adding propylene glycol and stirring uniformly, adding purified water, stirring uniformly, canning, capping, sterilizing for 30min at 115 ℃ under damp heat, taking out, cooling, inspecting, packaging after passing, and obtaining the gel dressing (the color is colorless and transparent and meets the requirements).
Example 5
The components of the gel dressing: galactooligosaccharide (comprising 25% by mass of a compound having a structural unit represented by formula 1 and 75% by mass of a compound having a structural unit represented by formula 2) 2%, fucoidan 0.2%, carbomer 9403%, glycerol 3%, propylene glycol 9%, absolute ethanol 11%, triethanolamine 3%, ethylparaben 0.1% and the balance purified water;
the preparation process comprises the following steps:
swelling carbomer 940 with 3 times of purified water, and sequentially adding glycerol and triethanolamine to obtain transparent gel matrix; mixing oligomeric galactosan sulfate, fucoidan and absolute ethyl alcohol to obtain a solution A; adding the solution A and the ethylparaben into the transparent gel matrix, stirring uniformly, gradually adding propylene glycol and stirring uniformly, adding purified water, stirring uniformly, canning, capping, sterilizing for 30min at 115 ℃ under damp heat, taking out, cooling, inspecting, packaging after passing, and obtaining the gel dressing (the color is colorless and transparent and meets the requirements).
Example 6
The components of the gel dressing: 1% of galactooligosaccharide (comprising 25% of a compound with a structural unit shown in a formula 1 and 75% of a compound with a structural unit shown in a formula 2), 1% of fucoidan, 9403% of carbomer, 3% of glycerol, 9% of propylene glycol, 11% of absolute ethyl alcohol, 3% of triethanolamine, 0.1% of ethylparaben and the balance of purified water;
the preparation process comprises the following steps:
swelling carbomer 940 with 3 times of purified water, and sequentially adding glycerol and triethanolamine to obtain transparent gel matrix; mixing oligomeric galactosan sulfate, fucoidan and absolute ethyl alcohol to obtain a solution A; adding the solution A and the ethylparaben into the transparent gel matrix, stirring uniformly, gradually adding propylene glycol and stirring uniformly, adding purified water, stirring uniformly, canning, capping, sterilizing for 30min at 115 ℃ under damp heat, taking out, cooling, inspecting, packaging after passing, and obtaining the gel dressing (the color is colorless and transparent and meets the requirements).
Comparative example 1
The procedure of example 1 was repeated except that the galactooligosaccharide sulfate was not added in the procedure of example 1.
Comparative example 2
The components of the gel dressing: brown algae polysaccharide 2%, carbomer 9403%, glycerin 3%, propylene glycol 9%, absolute ethyl alcohol 11%, triethanolamine 3%, ethylparaben 0.1% and the balance of purified water;
the preparation process comprises the following steps:
swelling carbomer 940 with 3 times of purified water, and sequentially adding glycerol and triethanolamine to obtain transparent gel matrix; mixing brown algae polysaccharide and absolute ethyl alcohol to obtain a solution A; adding the solution A and the ethylparaben into the transparent gel matrix, stirring uniformly, gradually adding propylene glycol and stirring uniformly, adding purified water, stirring uniformly, canning, capping, sterilizing for 30min at 115 ℃ under damp heat, taking out, cooling, inspecting, packaging after passing, and obtaining the gel dressing (the color is colorless and transparent and meets the requirements).
Test case
1. Basic performance detection
The gel dressings prepared in examples 1 to 6 were subjected to basic performance detection, wherein the appearance was examined by visual inspection, and the pH, viscosity, heavy metals, and sterility index were measured according to the methods prescribed in the four parts of the chinese pharmacopoeia 2020 edition.
Galactose adopts a phenol sulfuric acid colorimetric method: diluting 200 mug/mL of D-galactose standard solution into solutions with mass concentrations of 20, 40, 60, 80, 100, 120, 160 and 200 mug/mL respectively, precisely measuring 0.2mL of each diluted solution respectively, placing the diluted solutions into a 10mL test tube, adding 0.4mL of 50g/L phenol solution respectively, uniformly mixing, quickly adding 2mL of concentrated sulfuric acid respectively, uniformly mixing, placing the mixed solution at room temperature for 30min, taking purified water as a blank control, measuring absorbance A at a wavelength of 490nm, and linearly regressing absorbance A by galactose standard solution concentration C to prepare a standard curve. The samples were measured under the same conditions and the galactose content was determined by reference to a standard curve.
The test results are shown in table 1:
table 1 basic properties of gel dressings prepared in examples 1 to 6
As can be seen from Table 1, the basic properties of the gel dressings prepared in examples 1 to 6 meet the requirements, which indicates that the preparation method is simple and effective.
2. Vaginal irritation and skin irritation test
The gel dressings prepared in examples 1 to 6 were subjected to a vaginal stimulation and skin stimulation test.
Wherein the vaginal stimulation test is according to GB/T16886.10-2017, medical device biology evaluation part 10: the gel dressings prepared in examples 1 to 6 were contacted with the vaginal tissue of New Zealand rabbits as test groups and 0.9% sodium chloride injection was contacted with the vaginal tissue of New Zealand rabbits as control groups, and the potential of the gel dressings prepared in examples 1 to 6 to produce a vaginal tissue stimulation reaction under the test conditions was evaluated.
As a result, it was found that under the test conditions, the animals in the test group and the animals in the control group had no phenomenon of fluid discharge, erythema and edema at the vaginal orifice and perineum after the initial contact (24.+ -.2) and before each test operation (24.+ -.2) h, and the animals in the test group and the animals in the control group had no phenomenon of irritation, damage and necrosis at the vaginal epithelium layer, and the vaginal irritation indexes of the gel dressings prepared in examples 1 to 6 were 0.67, 0.52, 0.65, 0.58, 0.62 and 0.54, respectively, i.e., the type of vaginal irritation reaction was non-irritating.
Skin irritation test using GB/T16886.10-2017 medical instruments biological evaluation part 10: irritation and skin sensitization test the closed patch test method recommended in the skin sensitization test of guinea pigs 7.6 was evaluated for the potential of the gel dressings prepared in examples 1 to 6 to produce skin sensitization in guinea pigs under test conditions.
The gel dressings prepared in examples 1 to 6 were applied to test animals by means of a closed application as required by the standard. The gel dressing prepared in examples 1 to 6 was used to excite the test animals 14 days after the induction period, 24 hours after the first excitation, animal fur at the excitation site and surrounding sites was shaved off, at least 2 hours after the dehairing, and skin conditions of the animal test area were observed and described and classified 48 hours after the excitation patch was removed. The negative control group (0.9% sodium chloride injection) and the positive control group (1-chloro-2, 4-dinitrobenzene) were tested animals in the same manner.
As a result, it was found that the gel dressings prepared in examples 1 to 6 did not cause skin sensitization under the test conditions, and the occurrence of positive excitation results was 0%.
From the above, it can be seen that the gel dressings prepared in examples 1 to 6 are not irritating to the vagina and skin, and are safe to use.
3. Clinical effects against HPV infection
The gel dressings prepared in examples 1 to 6 and comparative examples 1 to 2 were combined with 9 groups of negative control groups, each group was selected from 65 patients with mixed HPV, the ages were 25 to 55 years, and the treatment was repeated 1, 2 and 3 months after treatment, and the treatment effect of each group of gel dressing was examined, and the results are shown in Table 2.
TABLE 2 anti-HPV test results
As can be seen from Table 2, the gel dressing prepared by the method has a negative conversion rate of 90.77-98.46% after 3 months, and has a good HPV infection resistance effect. In comparative example 1, after the oligomeric galactosan sulfate is not added on the basis of example 1, the negative conversion rate after 3 months is only 16.92%; in comparative example 2, the conversion rate of negative after 3 months was 72.31% after the fucoidan was replaced with fucoidan, and it can be seen that the anti-HPV effect of fucoidan alone was lower than that of fucoidan alone. As can be seen from examples 2, 5 and 6, the weight ratio of the galactooligosaccharide and the fucan was controlled to be (1 to 10): 1, the prepared gel dressing has negative conversion rates of 98.46%, 96.85% and 90.77% after 3 months, and has better HPV infection resistance effect, and can be seen that the brown algae polysaccharide and the galactooligosaccharide oligosulfate have synergistic function.
The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention.
Claims (10)
1. A gel dressing, characterized by comprising the following components in percentage by mass: 1 to 5 percent of anti-HPV active component, 1 to 5 percent of gel matrix, 1 to 15 percent of glycerol, 0.1 to 15 percent of propylene glycol, 0.1 to 15 percent of absolute ethyl alcohol, 1 to 5 percent of triethanolamine, 0.01 to 0.5 percent of ethylparaben and the balance of purified water;
the anti-HPV active component comprises a mixture of galactooligosaccharide and fucan or galactooligosaccharide.
2. The gel dressing of claim 1, comprising the following components in mass percent: 2 to 3 percent of anti-HPV active component, 2 to 5 percent of gel matrix, 1 to 10 percent of glycerol, 1 to 9 percent of propylene glycol, 1 to 11 percent of absolute ethyl alcohol, 1 to 5 percent of triethanolamine, 0.1 to 0.4 percent of ethylparaben and the balance of purified water.
3. The gel dressing of claim 1 or 2, wherein the gel matrix is one or more of carbomer 940, carbomer 941, carbomer 934 and sodium carboxymethyl cellulose.
4. Gel dressing according to claim 1 or 2, wherein when the anti-HPV active component comprises a mixture of galactooligosaccharide and fucan, the mass ratio of galactooligosaccharide and fucan is (1-10): 1.
5. the gel dressing of claim 1 or 2, wherein the galactooligosaccharide sulfate comprises a compound having a structure shown in formula 1 and a compound having a structure shown in formula 2; wherein the weight percentage of the compound with the structure shown in the formula 1 in the oligomeric sulfuric acid galactan is 5-50%, and the weight percentage of the compound with the structure shown in the formula 2 in the oligomeric sulfuric acid galactan is 50-95%;
wherein in the formulas 1 and 2, R 1 、R 2 、R 3 Independently H or SO 3 - N is a positive integer of 15 to 100.
6. A method of preparing a gel dressing according to any one of claims 1 to 5, comprising the steps of:
after swelling the gel matrix by purified water, sequentially adding glycerol and triethanolamine to obtain a transparent gel matrix;
mixing the HPV-resistant active component with absolute ethyl alcohol to obtain a solution A;
and adding the solution A and the ethylparaben into the transparent gel matrix, and sequentially adding propylene glycol and purified water to obtain the gel dressing.
7. The method according to claim 6, wherein the mass of the purified water used in the swelling treatment is 2 to 4 times the mass of the gel matrix.
8. The method according to claim 5, wherein after the propylene glycol and the purified water are sequentially added, further comprising sequentially performing filling, capping and sterilization;
the sterilization is damp-heat sterilization;
the sterilization temperature is 115 ℃ and the sterilization time is 30-40 min.
9. Use of a gel dressing according to any one of claims 1 to 5 or a gel dressing prepared by a preparation method according to any one of claims 6 to 8 in the preparation of an external preparation for the treatment and/or prevention of HPV and gynaecological diseases.
10. The use according to claim 9, wherein the gynaecological disease is caused by a bacterial or viral infection.
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