CN111603440A - Gynecological gel foaming agent and preparation method thereof - Google Patents

Gynecological gel foaming agent and preparation method thereof Download PDF

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Publication number
CN111603440A
CN111603440A CN202010597997.9A CN202010597997A CN111603440A CN 111603440 A CN111603440 A CN 111603440A CN 202010597997 A CN202010597997 A CN 202010597997A CN 111603440 A CN111603440 A CN 111603440A
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chitosan
mixed solution
parts
water
gel
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李亚军
张健
冯瑞茹
贡艳
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Nanjing Dongwan Biotechnology Co ltd
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Nanjing Dongwan Biotechnology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/722Chitin, chitosan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/28Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • A61K9/122Foams; Dry foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Reproductive Health (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Dispersion Chemistry (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gynecology & Obstetrics (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Virology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention provides a gynecological gel foaming agent, which comprises a gel solution and a propellant, wherein the gel solution comprises chitosan or chitosan derivatives, a solubilizer, a water-soluble polymer, a surfactant, a bacteriostatic agent, a protein repair factor and water. The invention has the beneficial effects that: the foaming agent has the advantages of simple preparation method, stable product performance, good antibacterial and bactericidal effects, and safe, sanitary and convenient use, and is suitable for treating various vaginitis, protecting cervix, repairing wound surface, and promoting ulcer healing.

Description

Gynecological gel foaming agent and preparation method thereof
Technical Field
The invention relates to the field of gynecological cleaning agents, in particular to a gynecological gel foaming agent and a preparation method thereof.
Background
Gynecological diseases such as vaginitis are common frequently-occurring diseases, and common diseases such as pruritus, burning pain, irritation, abnormal fluid and the like have great influence on normal work and life. Many clinical medicines can produce some side effects, and influence the health to a certain extent. In addition to vaginitis, cervical cancer is also a gynecological disease that is prone to occur, causing a great deal of damage to the female body and health.
Disclosure of Invention
The invention overcomes the defects in the prior art and provides a gynecological gel foaming agent and a preparation method thereof.
The purpose of the invention is realized by the following technical scheme.
A gynecological gel foaming agent comprises a gel solution and a propellant, wherein the gel solution comprises chitosan or chitosan derivatives, a solubilizer, a water-soluble polymer, a surfactant, a bacteriostatic agent, a protein repair factor and water.
Preferably, the gel solution comprises the following components in parts by weight: 0.1-3 parts of chitosan or chitosan derivative, 0.5-5 parts of solubilizer, 0.1-5 parts of water-soluble polymer, 0.1-10 parts of surfactant, 0.01-5 parts of bacteriostatic agent, 0.001-1 part of protein repair factor and the balance of water.
In any of the above schemes, preferably, the propellant is added in a proportion of 1-50 parts per hundred parts of the gel solution.
In any of the above schemes, preferably, the chitosan or chitosan derivative is one or more of chitosan, chitosan oligosaccharide, chitosan quaternary ammonium salt, chitosan hydrochloride, chitosan lactate, and carboxymethyl chitosan.
In any of the above embodiments, preferably, the solubilizer is one or more of glycerol, propylene glycol, butylene glycol, pentylene glycol, hydrogenated castor oil.
In any of the above embodiments, preferably, the water-soluble polymer is one or more of hydroxyethyl cellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, polyquaternium 1, polyquaternium 6, guar gum, and xanthan gum.
In any of the above schemes, preferably, the surfactant is one or more of alkylphenol ethoxylates, polyoxyethylene fatty acid esters, polyoxyethylene alkylamides, sucrose fatty acid esters, span, tween and poloxamer.
In any of the above schemes, preferably, the bacteriostatic agent is one or more of sorbic acid or sorbate, methyl paraben, ethyl paraben, propyl paraben, benzyl alcohol, polyhexamethylene biguanide, polylysine and natamycin.
In any one of the above embodiments, preferably, the protein repair factor is an adipose-derived stem cell extract.
A preparation method of a gynecological gel foaming agent comprises the following steps:
firstly, adding a solubilizer in a formula amount into water in a formula amount, and uniformly stirring to obtain a mixed solution I;
secondly, adding chitosan or chitosan derivatives with the formula amount into the mixed solution I, and uniformly stirring to obtain a mixed solution II;
thirdly, adding the water-soluble polymer with the formula amount into the mixed solution II, and uniformly stirring to obtain a mixed solution III;
fourthly, adding the surfactant with the formula amount into the third mixed solution, and uniformly stirring to obtain a fourth mixed solution;
fifthly, adding the bacteriostatic agent and the protein repair factor in the formula amount into the mixed solution IV, and uniformly stirring to obtain a mixed solution V;
and sixthly, filling the mixed solution V into a bottle, and then pressing the propellant with the formula amount into the bottle to obtain the gynecological gel foaming agent.
The invention has the beneficial effects that:
the foaming agent has the same osmotic pressure as body fluid, can effectively permeate into vagina, is uniformly distributed in the vaginal cavity and on the surface of skin, has fine and dense foam and good biocompatibility with the skin, improves the absorption rate of the medicine, increases the bioavailability of the medicine, and promotes the absorption of the medicine preparation.
The chitosan or chitosan derivative is commonly used as a carrier material in the field of medicine, can control the release of medicines, has good antibacterial performance and can effectively inhibit the propagation of bacteria and fungi.
The foaming agent has the advantages of simple preparation method, stable product performance, good antibacterial and bactericidal effects, and safe, sanitary and convenient use, and is suitable for treating various vaginitis, protecting cervix, repairing wound surface, and promoting ulcer healing.
Detailed Description
The technical solution of the present invention is further illustrated by the following specific examples.
Chitosan or chitosan derivative is subjected to chemical reaction to prepare N, O-hydroxymethylation chitosan with bacteriostatic activity, wherein the relative molecular mass has obvious influence on the bacteriostatic activity, for example, the bacteriostatic activity is obviously enhanced along with the reduction of the relative molecular mass, and when the relative molecular mass is lower than 5000, the material has obvious effect of inhibiting and killing staphylococcus aureus; after the chitosan is dissolved in acid, the-NH 2 on the sugar chain is combined with H < + > to form a strong positive charge cationic group, which is very beneficial to improving the acidic constitution;
solubilizers have been widely used for solubilizing poorly soluble drugs to obtain clear or clear solutions of higher concentration suitable for therapeutic needs;
the water-soluble polymer has flocculation effect, is an effective polymeric flocculant, and has charged parts capable of neutralizing the charges of colloidal particles, destroying the stability of the colloidal particles in water, promoting the collision of the colloidal particles, and entangling a plurality of fine particles together through macromolecular long-chain bridges to aggregate the fine particles into large particles, thereby accelerating the sedimentation. The flocculation and sedimentation speed is high, the sludge dewatering efficiency is high, and the special effect is achieved on the treatment of certain wastewater;
the surface active agent can be used as a bactericide and a disinfectant in the pharmaceutical industry, the sterilization and disinfection effects of the surface active agent are attributed to the fact that the surface active agent and the bacterial biofilm protein are denatured or nonfunctional due to strong interaction, the disinfectants have relatively high solubility in water, and can be used for skin disinfection, wound or mucosa disinfection, instrument disinfection and environment disinfection before operation according to the using concentration; meanwhile, the surfactant has the effect of changing a solution system, increasing the viscosity and thickening or increasing the foam of the system;
the bacteriostatic agent has obvious antibacterial effect, strong deodorization effect, and is colorless, transparent and odorless;
the protein repair factor has self-renewal, proliferation and multi-directional differentiation potential, can be differentiated into fat cells, cartilage cells, muscle cells, osteoblasts, nerve cells, glial cells and islet cells, can secrete various angiogenesis promoting factors and anti-apoptosis factors to resist inflammation and oxidation, and can resist damage of oxygen free radicals
The propellant helps to hasten the formation of foam;
the gynecological external antibacterial foaming agent has the characteristics of broad-spectrum physical antibacterial property, no drug resistance, lasting efficacy, stronger sterilizing power when meeting water, safety, environmental protection and the like, is an ideal novel gynecological antibacterial anti-inflammatory preparation, adopts the foaming agent to generate fine and soft foam, can be quickly dispersed through filling and retaining effects, ensures that the main drug is distributed and permeated in the medicine application part in a solution state, has direct effect, is beneficial to absorption, is more thorough in sterilization, and achieves more effective treatment.
Example 1
A gel solution of the gynecological gel foaming agent is prepared from the following raw materials in percentage by weight: 0.5 part of chitosan, 2 parts of glycerol, 0.5 part of hydroxyethyl cellulose, 0.2 part of alkylphenol polyoxyethylene, 0.1 part of methyl paraben, 0.01 part of adipose-derived stem cell extracting solution and 96.6 parts of water; 10 parts of propellant are added into the gel solution.
A preparation method of a gynecological gel foaming agent comprises the following steps:
step one, adding 0.5 part of glycerol into 96.6 parts of water, and uniformly stirring to obtain a mixed solution I;
secondly, adding 0.5 part of chitosan into the mixed solution I, and uniformly stirring to obtain a mixed solution II;
thirdly, adding 0.5 part of hydroxyethyl cellulose into the mixed solution II, and uniformly stirring to obtain a mixed solution III;
fourthly, adding 0.2 part of alkylphenol polyoxyethylene into the third mixed solution, and uniformly stirring to obtain a fourth mixed solution;
fifthly, adding 0.1 part of methyl paraben and 0.01 part of adipose-derived stem cell extracting solution into the fourth mixed solution, and uniformly stirring to obtain a fifth mixed solution;
and sixthly, filling the mixed solution five into a bottle, and then pressing 10 parts of propellant into the mixed solution five to obtain the gynecological gel foaming agent.
Example 2:
a gel solution of the gynecological gel foaming agent is prepared from the following raw materials in percentage by weight: 1 part of chitosan lactate, 3 parts of propylene glycol, 0.5 part of hydroxypropyl cellulose, 0.3 part of polyoxyethylene alkyl amide, 0.2 part of sorbic acid, 0.01 part of an adipose-derived stem cell extracting solution and 94.9 parts of water; 20 parts of propellant are added into the hundred parts of gel solution.
A preparation method of a gynecological gel foaming agent comprises the following steps:
step one, adding 3 parts of propylene glycol into 94.9 parts of water, and uniformly stirring to obtain a mixed solution I;
secondly, adding 1 part of chitosan lactate into the first mixed solution, and uniformly stirring to obtain a second mixed solution;
step three, adding 0.5 part of hydroxypropyl cellulose into the mixed solution II, and uniformly stirring to obtain a mixed solution III;
fourthly, adding 0.3 part of polyoxyethylene alkylamide into the third mixed solution, and uniformly stirring to obtain a fourth mixed solution;
fifthly, adding 0.2 part of sorbic acid and 0.01 part of adipose-derived stem cell extracting solution into the fourth mixed solution, and uniformly stirring to obtain a fifth mixed solution;
and sixthly, filling the mixed solution five into a bottle, and then pressing 20 parts of propellant into every hundred parts of the mixed solution five to obtain the gynecological gel foaming agent.
Example 3:
the gynecological gel foaming agent is prepared from the following raw materials in percentage by weight: 2 parts of chitosan quaternary ammonium salt, 4 parts of pentanediol, 1 part of carboxymethyl cellulose, 0.5 part of poloxamer, 0.02 part of polyhexamethylene biguanide, 0.01 part of adipose-derived stem cell extracting solution and 92.38 parts of water; 30 parts of propellant is added into the hundred parts of gel solution.
A preparation method of a gynecological gel foaming agent comprises the following steps:
step one, adding 4 parts of pentanediol into 92.38 parts of water, and uniformly stirring to obtain a mixed solution I;
secondly, adding 2 parts of chitosan quaternary ammonium salt into the mixed solution I, and uniformly stirring to obtain a mixed solution II;
step three, adding 1 part of cellulose glycolate into the mixed solution II, and uniformly stirring to obtain a mixed solution III;
fourthly, adding 0.5 part of poloxamer into the third mixed solution, and uniformly stirring to obtain a fourth mixed solution;
fifthly, adding 0.02 part of polyhexamethylene biguanide and 0.01 part of adipose-derived stem cell extracting solution into the mixed solution IV, and uniformly stirring to obtain a mixed solution V;
and sixthly, filling the mixed solution five into a bottle, and then pressing 30 parts of propellant into every hundred parts of the mixed solution five to obtain the gynecological gel foaming agent.
The three embodiments of the present invention have been described in detail, but the description is only for the preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. All equivalent changes and modifications made within the scope of the present invention shall fall within the scope of the present invention.

Claims (10)

1. The gynecological gel foaming agent is characterized in that: the gel comprises a gel solution and a propellant, wherein the gel solution comprises chitosan or chitosan derivatives, a solubilizer, a water-soluble polymer, a surfactant, a bacteriostatic agent, a protein repair factor and water.
2. The gynecological gel foam formulation of claim 1, characterized in that: the gel solution comprises the following components in parts by weight: 0.1-3 parts of chitosan or chitosan derivative, 0.5-5 parts of solubilizer, 0.1-5 parts of water-soluble polymer, 0.1-10 parts of surfactant, 0.01-5 parts of bacteriostatic agent, 0.001-1 part of protein repair factor and the balance of water.
3. The gynecological gel foam formulation according to claim 2, characterized in that: the propellant is added in a proportion of 1-50 parts per hundred parts of the gel solution.
4. The gynecological gel foam formulation according to claim 3, characterized in that: the chitosan or chitosan derivative is one or more of chitosan, chitosan oligosaccharide, chitosan quaternary ammonium salt, chitosan hydrochloride, chitosan lactate and carboxymethyl chitosan.
5. The gynecological gel foam formulation according to claim 3, characterized in that: the solubilizer is one or more of glycerol, propylene glycol, butanediol, pentanediol and hydrogenated castor oil.
6. The gynecological gel foam formulation according to claim 3, characterized in that: the water-soluble polymer is one or more of hydroxyethyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose, polyquaternium 1, polyquaternium 6, guar gum and xanthan gum.
7. The gynecological gel foam formulation according to claim 3, characterized in that: the surfactant is one or more of alkylphenol polyoxyethylene, polyoxyethylene fatty acid ester, polyoxyethylene alkylamide, sucrose fatty acid ester, span, tween and poloxamer.
8. The gynecological gel foam formulation according to claim 3, characterized in that: the bacteriostatic agent is one or more of sorbic acid or sorbate, methyl paraben, ethyl paraben, propyl paraben, benzyl alcohol, polyhexamethylene biguanide, polylysine and natamycin.
9. The gynecological gel foam formulation according to claim 3, characterized in that: the protein repair factor is an adipose-derived stem cell extracting solution.
10. A process for the preparation of a gynaecological gel foam according to any of claims 1 to 9, characterized in that: the method comprises the following steps:
firstly, adding a solubilizer in a formula amount into water in a formula amount, and uniformly stirring to obtain a mixed solution I;
secondly, adding chitosan or chitosan derivatives with the formula amount into the mixed solution I, and uniformly stirring to obtain a mixed solution II;
thirdly, adding the water-soluble polymer with the formula amount into the mixed solution II, and uniformly stirring to obtain a mixed solution III;
fourthly, adding the surfactant with the formula amount into the third mixed solution, and uniformly stirring to obtain a fourth mixed solution;
fifthly, adding the bacteriostatic agent and the protein repair factor in the formula amount into the mixed solution IV, and uniformly stirring to obtain a mixed solution V;
and sixthly, filling the mixed solution V into a bottle, and then pressing the propellant with the formula amount into the bottle to obtain the gynecological gel foaming agent.
CN202010597997.9A 2020-06-28 2020-06-28 Gynecological gel foaming agent and preparation method thereof Pending CN111603440A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113576978A (en) * 2021-08-27 2021-11-02 黄桦 Composition containing orange medicinal material extract and preparation method and application thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102872159A (en) * 2012-09-29 2013-01-16 广东同德药业有限公司 Nano-silver chitosan gel foam preparation for treating vaginal bacterial inflammation, and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102872159A (en) * 2012-09-29 2013-01-16 广东同德药业有限公司 Nano-silver chitosan gel foam preparation for treating vaginal bacterial inflammation, and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113576978A (en) * 2021-08-27 2021-11-02 黄桦 Composition containing orange medicinal material extract and preparation method and application thereof

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