CN113230205A - Gynecological gel preparation and preparation method and application thereof - Google Patents
Gynecological gel preparation and preparation method and application thereof Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7016—Disaccharides, e.g. lactose, lactulose
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- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
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- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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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
- A61K47/30—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
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- 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
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- 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
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- 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
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- 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
- A61P31/02—Local antiseptics
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P31/04—Antibacterial agents
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
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- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The invention discloses a gynecological gel preparation and a preparation method and application thereof, relating to the field of biomedicine, and the key points of the technical scheme are as follows: comprises yolk powder, carbomer, propylene glycol, antiseptic, glycerol, anhydrous alcohol, chlorhexidine gluconate, penetrant, lactose and appropriate amount of distilled water. The invention can radically cure vaginitis, accelerate disease repair treatment, maintain natural vagina moistening, keep the elasticity of the inner wall of the vagina, have hemostatic function and good permeability, can quickly heal wounds of disease parts, diminish inflammation, relieve the pain, prevent bacteria regeneration and play a role in maintenance by reasonably proportioning the components and the contents.
Description
Technical Field
The invention relates to the field of biomedicine, in particular to a gynecological gel preparation and a preparation method and application thereof.
Background
Gynecological problems such as vaginitis, cervical erosion, hysteromyoma and the like greatly disturb the daily life of women, directly affect the physical and mental health of women and the life of couples, and the vaginal problems are not ignored in a plurality of gynecological diseases. The physiological characteristics of the female vagina, the particularity of the anatomical structure and the weakly acidic local environment enable various normal parasitic flora and conditional pathogenic bacteria to be interdependent and mutually restricted, but the normal flora also has the risk of transforming into the pathogenic bacteria, the occurrence of the pathogenic bacteria can cause genital tract infection, vaginitis is easy to relapse, the vaginitis is vaginitis, namely vagina inflammation, the vagina inflammation caused by bacterial infection is a common and frequently encountered gynecological disease and is a group of diseases causing vulvovaginal symptoms such as pruritus, causalgia, stimulation and abnormal fluid, and if a medicine prescription is not rational, the acid-base balance of the flora in the vagina can be damaged.
Therefore, a new solution is needed to solve this problem.
Disclosure of Invention
The present invention aims at providing one kind of gynecological gel preparation and its preparation process and application.
The technical purpose of the invention is realized by the following technical scheme: a gynecological gel preparation comprises yolk powder, carbomer, propylene glycol, antiseptic, glycerol, anhydrous alcohol, chlorhexidine gluconate, lactose and distilled water.
The invention is further configured to: according to the weight ratio, 40g to 60g of yolk powder, 450g to 550g of carbomer, 10ml to 20ml of propylene glycol, 3g to 5g of glycerol, 25ml to 35ml of absolute ethyl alcohol, 2g to 5g of chlorhexidine gluconate and 80g to 120g of distilled water.
The invention is further configured to: the preservative is polyhexamethylene guanidine.
The invention is further configured to: the concentration of the polyhexamethylene guanidine is 0.15-0.35% W/W.
The invention is further configured to: the penetrant is azone.
A preparation method of gynecological gel preparation comprises the following steps:
a. putting a proper amount of distilled water into a clean container, weighing carbomer according to the specific gravity, uniformly scattering the carbomer on the water surface of the distilled water, standing for a period of time to fully swell the carbomer, adding glycerol, and stirring to form paste;
b. placing appropriate amount of distilled water in another clean container, adding yolk powder, antiseptic, chlorhexidine gluconate and lactose, and stirring to dissolve completely;
c. uniformly mixing azone, propylene glycol and absolute ethyl alcohol;
d. mixing the materials obtained in step a, step b and step c, stirring, adding the rest distilled water, slowly adding tea tree oil dropwise while stirring, controlling pH to 6.0-6.5, and packaging.
An application of gynecological gel preparation in preparing medicine for preventing and treating gynecological inflammation diseases is disclosed.
In conclusion, the invention has the following beneficial effects:
the invention can radically cure vaginitis by reasonable proportion of each component and content. The chlorhexidine gluconate and the polyhexamethylene guanidine can be matched to quickly and effectively kill various bacteria, fungi and viruses, and play a role in killing pathogenic bacteria and relieving inflammatory symptoms in a short time; the carbomer can maintain the pH value acidic state (pH 3-5) of the vagina for a long time, promote the propagation of dominant bacteria such as lactic acid bacteria and the like, and inhibit the propagation of anaerobic bacteria, so that the balance of microbial flora in the vagina of a female is adjusted, the healthy vaginal environment is maintained, the carbomer has a biological viscosity effect, can be tightly adhered to vaginal epithelial cells, and can well contact with inflammation parts to completely eliminate diseases; yolk powder and lactose can provide a large amount of nutrients for repairing the disease parts, supplement water and nutrition for vaginal mucosa, accelerate disease repairing treatment, maintain natural moisture of vagina and keep the elasticity of the inner wall of the vagina; the tea tree oil is matched, so that the effects of better disinfection and bacteriostasis can be achieved, the hemostatic function and the good permeability are achieved, the wound at the disease part can be quickly healed, the inflammation is reduced, the relief is realized, the bacterial regeneration is prevented, and the maintenance effect is achieved; meanwhile, the azone is a skin penetration enhancer with excellent penetration effect, can enable the medicine to well penetrate into the skin of a disease part to generate the effect, and effectively prevents or treats gynecological inflammation diseases such as vaginitis, cervicitis and the like.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The first embodiment is as follows: a gynecological gel preparation is prepared from yolk powder 40g, carbomer 450g, propylene glycol 10ml, polyhexamethylene guanidine 0.15% -0.35% W/W, appropriate amount of lactose, glycerol 3g, anhydrous ethanol 25ml, chlorhexidine gluconate 2g, and distilled water 80 g; uniformly spreading carbomer on a proper amount of distilled water, standing to fully swell carbomer, adding glycerol, and stirring to obtain paste; dissolving yolk powder, antiseptic, chlorhexidine gluconate and lactose with appropriate amount of distilled water; uniformly mixing azone, propylene glycol and absolute ethyl alcohol; mixing the above materials, stirring, slowly adding tea tree oil dropwise while stirring, controlling pH to 6.0-6.5, and packaging.
Example two: a gynecological gel preparation is prepared from yolk powder 50g, carbomer 500g, propylene glycol 25ml, polyhexamethylene guanidine 0.15% -0.35% W/W, appropriate amount of lactose, glycerol 5g, anhydrous ethanol 30ml, chlorhexidine gluconate 3g, and distilled water 100 g; uniformly spreading carbomer on a proper amount of distilled water, standing to fully swell carbomer, adding glycerol, and stirring to obtain paste; dissolving yolk powder, antiseptic, chlorhexidine gluconate and lactose with appropriate amount of distilled water; uniformly mixing azone, propylene glycol and absolute ethyl alcohol; mixing the above materials, stirring, slowly adding tea tree oil dropwise while stirring, controlling pH to 6.0-6.5, and packaging.
Example three: a gynecological gel preparation is prepared from yolk powder 60g, carbomer 550g, propylene glycol 10ml, polyhexamethylene guanidine 0.15% -0.35% W/W, glycerol 3g, anhydrous ethanol 35ml, chlorhexidine gluconate 5g, and distilled water 120 g; uniformly spreading carbomer on a proper amount of distilled water, standing to fully swell carbomer, adding glycerol, and stirring to obtain paste; dissolving yolk powder, antiseptic, chlorhexidine gluconate and lactose with appropriate amount of distilled water; uniformly mixing azone, propylene glycol and absolute ethyl alcohol; mixing the above materials, stirring, slowly adding tea tree oil dropwise while stirring, controlling pH to 6.0-6.5, and packaging.
The gel of the invention is used for bacteriostasis test, the gynecological gel prepared in examples 1-3 is used for 5/10/15min on staphylococcus aureus, escherichia coli and candida albicans, and the result is shown in the table I:
watch 1
As can be seen from the table I, the average bacteriostasis rate of the vaginal suppository provided by the invention to conventional infectious bacteria of vaginitis, such as staphylococcus aureus, escherichia coli and candida albicans, reaches more than 90%, and the effect is obvious.
In addition, 100 patients with vaginitis are selected, the gynecological gel prepared in the second embodiment is directly applied to the vagina in the morning and evening every day, and the dosage is 8mL each time; after the inspection of the medicine after three months of use, the recovery shows that the subjective symptoms disappear, the effective shows that the subjective symptoms are relieved, and the ineffective shows that the subjective is normal and has no improvement.
Watch two
As can be seen from the second table, the gynecological gel has the effective rate of over 99 percent in improving the vaginal environment and over 98 percent in improving the vaginal dryness caused by improper cleaning, has very good effect, and has the recurrence rate of less than 3 percent after three months of medication, patients are cured and return visit after 3 months of medication withdrawal.
The above description is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above embodiments, and all technical solutions belonging to the idea of the present invention belong to the protection scope of the present invention. It should be noted that modifications and embellishments within the scope of the invention may occur to those skilled in the art without departing from the principle of the invention, and are considered to be within the scope of the invention.
Claims (7)
1. A gynecological gel preparation is characterized by comprising yolk powder, carbomer, propylene glycol, preservative, glycerol, anhydrous ethanol, chlorhexidine gluconate, lactose and appropriate amount of distilled water.
2. The gynecological gel preparation according to claim 1, wherein the yolk powder comprises 40g to 60g of yolk powder, 450g to 550g of carbomer, 10ml to 20ml of propylene glycol, 3g to 5g of glycerol, 25ml to 35ml of absolute ethyl alcohol, 2g to 5g of chlorhexidine gluconate and 80g to 120g of distilled water.
3. A gynecological gel formulation according to claim 1 wherein the preservative is polyhexamethylene guanidine.
4. A gynecological gel formulation according to claim 3 wherein the concentration of polyhexamethylene guanidine is between 0.15% and 0.35% W/W.
5. The gynecological gel formulation of claim 1, further comprising an osmotic agent, wherein the osmotic agent is azone.
6. A method of preparing a gynaecological gel formulation according to any of claims 1-5, comprising the steps of:
a. putting a proper amount of distilled water into a clean container, weighing carbomer according to the specific gravity, uniformly scattering the carbomer on the water surface of the distilled water, standing for a period of time to fully swell the carbomer, adding glycerol, and stirring to form paste;
b. placing appropriate amount of distilled water in another clean container, adding yolk powder, antiseptic, chlorhexidine gluconate and lactose, and stirring to dissolve completely;
c. uniformly mixing azone, propylene glycol and absolute ethyl alcohol;
d. mixing the materials obtained in step a, step b and step c, stirring, adding the rest distilled water, slowly adding tea tree oil dropwise while stirring, controlling pH to 6.0-6.5, and packaging.
7. Use of a gynaecological gel formulation according to any of claims 1-5 for the preparation of a medicament for the prevention and treatment of gynaecological inflammatory diseases.
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| CN202110561494.0A CN113230205B (en) | 2021-05-22 | 2021-05-22 | Gynecological gel preparation and preparation method and application thereof |
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| CN202110561494.0A CN113230205B (en) | 2021-05-22 | 2021-05-22 | Gynecological gel preparation and preparation method and application thereof |
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| CN113230205B CN113230205B (en) | 2023-07-07 |
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