CN112274480A - Preparation method of female contraceptive antibacterial gel lubricant - Google Patents
Preparation method of female contraceptive antibacterial gel lubricant Download PDFInfo
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- CN112274480A CN112274480A CN202011235443.0A CN202011235443A CN112274480A CN 112274480 A CN112274480 A CN 112274480A CN 202011235443 A CN202011235443 A CN 202011235443A CN 112274480 A CN112274480 A CN 112274480A
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- female contraceptive
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- 239000000314 lubricant Substances 0.000 title claims abstract description 20
- 230000000844 anti-bacterial effect Effects 0.000 title claims abstract description 19
- 229940124566 female contraceptive agent Drugs 0.000 title claims abstract description 19
- 238000002360 preparation method Methods 0.000 title claims abstract description 13
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 66
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 54
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 claims abstract description 36
- 239000002562 thickening agent Substances 0.000 claims abstract description 29
- 229920002101 Chitin Polymers 0.000 claims abstract description 27
- 235000011187 glycerol Nutrition 0.000 claims abstract description 24
- 239000000243 solution Substances 0.000 claims abstract description 21
- 235000016337 monopotassium tartrate Nutrition 0.000 claims abstract description 18
- KYKNRZGSIGMXFH-ZVGUSBNCSA-M potassium bitartrate Chemical compound [K+].OC(=O)[C@H](O)[C@@H](O)C([O-])=O KYKNRZGSIGMXFH-ZVGUSBNCSA-M 0.000 claims abstract description 18
- 229940086065 potassium hydrogentartrate Drugs 0.000 claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 17
- 238000002156 mixing Methods 0.000 claims abstract description 12
- 238000003756 stirring Methods 0.000 claims abstract description 12
- 239000011259 mixed solution Substances 0.000 claims abstract description 6
- 230000001954 sterilising effect Effects 0.000 claims abstract description 6
- 239000000499 gel Substances 0.000 claims description 24
- 229920001661 Chitosan Polymers 0.000 claims description 20
- 239000008367 deionised water Substances 0.000 claims description 16
- 229910021641 deionized water Inorganic materials 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 10
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 9
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims description 9
- 159000000000 sodium salts Chemical class 0.000 claims description 9
- 239000004743 Polypropylene Substances 0.000 claims description 7
- 229920002678 cellulose Polymers 0.000 claims description 7
- 239000001913 cellulose Substances 0.000 claims description 7
- -1 polypropylene Polymers 0.000 claims description 7
- 229920001155 polypropylene Polymers 0.000 claims description 7
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims description 5
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 5
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 5
- 239000005714 Chitosan hydrochloride Substances 0.000 claims description 5
- 108010010803 Gelatin Proteins 0.000 claims description 5
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 5
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 5
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims description 5
- 229920000148 Polycarbophil calcium Polymers 0.000 claims description 5
- 229920002125 Sokalan® Polymers 0.000 claims description 5
- 229960001631 carbomer Drugs 0.000 claims description 5
- 229920000159 gelatin Polymers 0.000 claims description 5
- 239000008273 gelatin Substances 0.000 claims description 5
- 235000019322 gelatine Nutrition 0.000 claims description 5
- 235000011852 gelatine desserts Nutrition 0.000 claims description 5
- 229920002674 hyaluronan Polymers 0.000 claims description 5
- 229960003160 hyaluronic acid Drugs 0.000 claims description 5
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 5
- 229920003063 hydroxymethyl cellulose Polymers 0.000 claims description 5
- 229940031574 hydroxymethyl cellulose Drugs 0.000 claims description 5
- 229950005134 polycarbophil Drugs 0.000 claims description 5
- 150000003242 quaternary ammonium salts Chemical class 0.000 claims description 5
- 235000015165 citric acid Nutrition 0.000 claims description 3
- 239000000126 substance Substances 0.000 claims description 2
- 210000001215 vagina Anatomy 0.000 abstract description 9
- 230000002378 acidificating effect Effects 0.000 abstract description 6
- 239000007853 buffer solution Substances 0.000 abstract description 3
- 241000894006 Bacteria Species 0.000 abstract description 2
- 230000003385 bacteriostatic effect Effects 0.000 abstract description 2
- 239000002994 raw material Substances 0.000 description 13
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 10
- 201000010099 disease Diseases 0.000 description 8
- 229940127234 oral contraceptive Drugs 0.000 description 6
- 239000003539 oral contraceptive agent Substances 0.000 description 6
- 208000005189 Embolism Diseases 0.000 description 2
- 206010020772 Hypertension Diseases 0.000 description 2
- 206010027514 Metrorrhagia Diseases 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 239000003433 contraceptive agent Substances 0.000 description 2
- 206010012601 diabetes mellitus Diseases 0.000 description 2
- 208000035475 disorder Diseases 0.000 description 2
- 230000004064 dysfunction Effects 0.000 description 2
- 230000003073 embolic effect Effects 0.000 description 2
- 210000000750 endocrine system Anatomy 0.000 description 2
- 210000003734 kidney Anatomy 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 230000006371 metabolic abnormality Effects 0.000 description 2
- 208000010125 myocardial infarction Diseases 0.000 description 2
- 239000000583 progesterone congener Substances 0.000 description 2
- 230000001850 reproductive effect Effects 0.000 description 2
- 210000004994 reproductive system Anatomy 0.000 description 2
- 230000004083 survival effect Effects 0.000 description 2
- 208000021959 Abnormal metabolism Diseases 0.000 description 1
- 208000006374 Uterine Cervicitis Diseases 0.000 description 1
- 206010046914 Vaginal infection Diseases 0.000 description 1
- 201000008100 Vaginitis Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 206010008323 cervicitis Diseases 0.000 description 1
- 230000002254 contraceptive effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000003974 emollient agent Substances 0.000 description 1
- 230000003054 hormonal effect Effects 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 239000012567 medical material Substances 0.000 description 1
- 210000000582 semen Anatomy 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- 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
- A61K31/716—Glucans
- A61K31/722—Chitin, chitosan
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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
- A61K47/08—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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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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- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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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
- A61K9/0012—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
- 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
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
-
- 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
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Abstract
The invention relates to a preparation method of a female contraceptive antibacterial gel lubricant, which is characterized in that L-lactic acid, citric acid and potassium hydrogen tartrate are prepared into mixed solution according to a proportion; preparing a water-soluble chitin derivative into a solution; preparing a thickening agent and glycerol into gel; mixing and stirring a solution prepared by preparing L-lactic acid, citric acid, potassium hydrogen tartrate, a thickening agent and glycerol into gel to obtain a component A; mixing water soluble chitin derivative solution with thickener and glycerin solution prepared into gel, and stirring to obtain component B; filling the component A and the component B in a two-component injector respectively, and sterilizing; the pH value of the vagina is adjusted to be within the normal range of 3.5-4.5 by a buffer system consisting of L-lactic acid, citric acid and potassium hydrogen tartrate, and the acidic environment is not suitable for the existence of sperms but is essential for the existence of healthy bacteria in the vagina. Meanwhile, under the acidic environment, the water-soluble chitin derivative with higher molecular weight is subjected to acidolysis, and the bacteriostatic performance is exerted.
Description
Technical Field
The invention relates to the technical field of medical materials, in particular to a preparation method of a female contraceptive antibacterial gel lubricant.
Background
The current oral contraceptive is a commonly used contraceptive method for women, the main component of the oral contraceptive is estrogen-progestogen, wherein the success rate of the short-acting oral contraceptive can reach as high as 99 percent, however, people with the disease history of liver and kidney metabolic abnormality, embolic diseases, cardiac dysfunction, hypertension, diabetes and the like are not suitable to use the oral contraceptive. The long-term use of normal people can also cause disorder of the reproductive and endocrine system, and cause diseases such as breakthrough bleeding, venous embolism, myocardial infarction and the like. Meanwhile, gynecological diseases are common diseases of women, such as vaginitis, cervicitis and the like, and are mostly caused by insanitary sexual life. Thus, there is a real need for a non-hormonal contraceptive method and an antimicrobial gel emollient for women.
Disclosure of Invention
The invention aims to provide a preparation method of a gel lubricant for female contraception and antibiosis, which achieves the purpose of contraception by adjusting the pH value of a vagina and is a non-hormonal contraception method; meanwhile, the water-soluble chitin derivative achieves the aim of antibiosis in an acid environment.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows: a preparation method of a female contraceptive antibacterial gel lubricant comprises the following steps:
(1) preparing mixed solution of L-lactic acid, citric acid and potassium hydrogen tartrate according to a proportion;
(2) preparing a water-soluble chitin derivative into a solution;
(3) preparing a thickening agent and glycerol into gel;
(4) mixing and stirring the solutions prepared in the steps (1) and (3) to obtain a component A;
(5) mixing and stirring the solutions prepared in the steps (2) and (3) to obtain a component B;
(6) and respectively filling the component A and the component B into a two-component injector, and sterilizing.
At present, the main component of the oral contraceptive is mainly female progestogen, however, people with the disease history of abnormal metabolism of liver and kidney, embolic diseases, cardiac dysfunction, hypertension, diabetes and the like are not suitable to use the oral contraceptive. The long-term use of normal people can also cause disorder of the reproductive and endocrine system, and cause diseases such as breakthrough bleeding, venous embolism, myocardial infarction and the like. The pH value of the vagina is controlled to be within a normal range of 3.5-4.5 by a buffer system consisting of L-lactic acid, citric acid and potassium hydrogen tartrate, and the acidic environment is not suitable for the existence of sperms.
Preferably, the mass ratio of the component A to the component B is 1: 1.
Preferably, the proportion of the L-lactic acid, the citric acid, the potassium hydrogen tartrate, the glycerol and the thickening agent in the component A is (0.5-3%), (0.4-2%), (0.1-1%) (0.6-12%), (0.5-15%) and the balance of deionized water.
Preferably, the ratio of the water-soluble chitin derivative to the glycerin to the thickener in the component B is (0.6-12%) to (0.5-12%), and the balance is deionized water.
Preferably, the water-soluble chitin derivative is one or more of chitosan lactate, chitosan hydrochloride, carboxymethyl chitosan potassium salt or sodium salt, chitosan acetate and chitosan quaternary ammonium salt.
Preferably, the thickening agent comprises cellulose and polypropylene substances, wherein the cellulose comprises hydroxymethyl cellulose and hydroxyethyl cellulose; the polypropylene includes carbomer and polycarbophil; hyaluronic acid, gelatin.
Compared with the prior art, the invention has the beneficial effects that:
(1) contains no hormone; the pH value of the vagina is usually increased to 7.0-8.0 by semen, and the pH value of the vagina is adjusted to be within a normal range of 3.5-4.5 (the normal pH value of the vagina of a female is within the range) by a buffer system consisting of L-lactic acid, citric acid and potassium hydrogen tartrate, so that the acidic environment of the vagina of the female is maintained, and the acidic environment is not suitable for the survival of sperms but is essential for the survival of healthy bacteria in the vagina. Meanwhile, under the acidic environment, the water-soluble chitin derivative with higher molecular weight is subjected to acidolysis, and the bacteriostatic performance is exerted.
Drawings
FIG. 1 is a schematic diagram of A, B components in example 1 of the preparation method of the female contraceptive antibacterial gel lubricant.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the 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 invention relates to a preparation method of a female contraceptive antibacterial gel lubricant, which consists of a component A and a component B according to the mass ratio of 1: 1, wherein the component A consists of the following raw materials in percentage by mass: 0.5-3% of L-lactic acid, 0.4-2% of citric acid, 0.1-1% of potassium hydrogen tartrate, 0.6-12% of glycerol, 0.5-15% of thickening agent and the balance of deionized water; the component B consists of the following raw materials in percentage by mass: 0.6-12% of water-soluble chitin derivative, 0.6-12% of glycerol, 0.5-12% of thickening agent and the balance of deionized water. The invention specifically comprises the following steps:
(1) preparing mixed solution of L-lactic acid, citric acid and potassium hydrogen tartrate according to a proportion;
(2) preparing a water-soluble chitin derivative into a solution according to a proportion;
(3) preparing gel with thickener and glycerol;
(4) mixing and stirring the solutions prepared in the steps (1) and (3) to obtain a component A;
(5) mixing and stirring the solutions prepared in the steps (2) and (3) to obtain a component B;
(6) filling component A and component B into two-component injector, and sterilizing
The component A of the invention comprises the following raw materials in a proper mass ratio: 1-2.5% of L-lactic acid, 0.5-1% of citric acid, 0.2-8% of potassium hydrogen tartrate, 1-8% of glycerol, 1-10% of thickening agent and the balance of deionized water; the component A comprises the following raw materials in a proper mass ratio: 0.6-12% of water-soluble chitin derivative, 0.6-12% of glycerol, 1-8% of thickening agent and the balance of deionized water.
The water-soluble chitin derivative is one or more of chitosan lactate, chitosan hydrochloride, carboxymethyl chitosan potassium salt or sodium salt, carboxymethyl chitin potassium salt or sodium salt, chitosan acetate and chitosan quaternary ammonium salt; cellulose as the thickener such as hydroxymethyl cellulose and hydroxyethyl cellulose; polypropylenes such as: carbomer, polycarbophil; hyaluronic acid, gelatin.
Example 1:
as shown in figure 1, the preparation method of the female contraceptive antibacterial gel lubricant comprises a component A and a component B according to the mass ratio of 1: 1, wherein the component A comprises the following raw materials in percentage by mass: l-lactic acid, citric acid, potassium hydrogen tartrate, glycerol, a thickening agent and the balance of deionized water; the component B consists of the following raw materials in percentage by mass: water-soluble chitin derivative, glycerin, thickening agent and the balance of deionized water. The invention specifically comprises the following steps:
(1) preparing mixed solution of L-lactic acid, citric acid and potassium hydrogen tartrate according to a proportion;
(2) preparing a water-soluble chitin derivative into a solution according to a proportion;
(3) preparing gel with thickener and glycerol;
(4) mixing and stirring the solutions prepared in the steps (1) and (3) to obtain a component A;
(5) mixing and stirring the solutions prepared in the steps (2) and (3) to obtain a component B;
(6) filling component A and component B into two-component injector, and sterilizing
The component A of the invention comprises the following raw materials in a proper mass ratio: 1% of L-lactic acid, 0.5% of citric acid, 0.2% of potassium hydrogen tartrate, 1% of glycerol, 1% of thickening agent and the balance of deionized water; the component A comprises the following raw materials in a proper mass ratio: 0.6 percent of water-soluble chitin derivative, 0.6 percent of glycerin, 1 percent of thickening agent and the balance of deionized water.
The water-soluble chitin derivative is one or more of chitosan lactate, chitosan hydrochloride, carboxymethyl chitosan potassium salt or sodium salt, carboxymethyl chitin potassium salt or sodium salt, chitosan acetate and chitosan quaternary ammonium salt; cellulose as the thickener such as hydroxymethyl cellulose and hydroxyethyl cellulose; polypropylenes such as: carbomer, polycarbophil; hyaluronic acid, gelatin.
Example 2:
a preparation method of a female contraceptive antibacterial gel lubricant comprises a component A and a component B according to the mass ratio of 1: 1, wherein the component A comprises the following raw materials in parts by mass: l-lactic acid, citric acid, potassium hydrogen tartrate, glycerol, a thickening agent and the balance of deionized water; the component B consists of the following raw materials in percentage by mass: water-soluble chitin derivative, glycerin, thickening agent and the balance of deionized water. The invention specifically comprises the following steps:
(1) preparing mixed solution of L-lactic acid, citric acid and potassium hydrogen tartrate according to a proportion;
(2) preparing a water-soluble chitin derivative into a solution according to a proportion;
(3) preparing gel with thickener and glycerol;
(4) mixing and stirring the solutions prepared in the steps (1) and (3) to obtain a component A;
(5) mixing and stirring the solutions prepared in the steps (2) and (3) to obtain a component B;
(6) filling component A and component B into two-component injector, and sterilizing
The component A of the invention comprises the following raw materials in a proper mass ratio: 2.5% of L-lactic acid, 1% of citric acid, 8% of potassium hydrogen tartrate, 8% of glycerol, 10% of thickening agent and the balance of deionized water; the component A comprises the following raw materials in a proper mass ratio: 12% of water-soluble chitin derivative, 12% of glycerol, 8% of thickening agent and the balance of deionized water.
The water-soluble chitin derivative is one or more of chitosan lactate, chitosan hydrochloride, carboxymethyl chitosan potassium salt or sodium salt, carboxymethyl chitin potassium salt or sodium salt, chitosan acetate and chitosan quaternary ammonium salt; cellulose as the thickener such as hydroxymethyl cellulose and hydroxyethyl cellulose; polypropylenes such as: carbomer, polycarbophil; hyaluronic acid, gelatin.
The preparation method of the female contraceptive antibacterial gel lubricant selects the raw materials, is safe to use, is simple and convenient to operate, and has no toxic or side effect; meanwhile, the preparation method of the female contraceptive antibacterial gel lubricant provided by the invention is low in cost, low in requirements on medical technical environment and simple to use.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.
Claims (8)
1. A preparation method of a female contraceptive antibacterial gel lubricant is characterized by comprising the following steps:
(1) preparing mixed solution of L-lactic acid, citric acid and potassium hydrogen tartrate according to a proportion;
(2) preparing a water-soluble chitin derivative into a solution;
(3) preparing a thickening agent and glycerol into gel;
(4) mixing and stirring the solutions prepared in the steps (1) and (3) to obtain a component A;
(5) mixing and stirring the solutions prepared in the steps (2) and (3) to obtain a component B;
(6) and respectively filling the component A and the component B into a two-component injector, and sterilizing.
2. A method of preparing a female contraceptive antibacterial gel lubricant as claimed in claim 1, wherein: the mass ratio of the component A to the component B is 1: 1.
3. A method of preparing a female contraceptive antibacterial gel lubricant as claimed in claim 2, wherein: the component A comprises L-lactic acid, citric acid, potassium hydrogen tartrate, glycerol and a thickening agent in a ratio of (0.5-3%), 0.4-2%, 0.1-1%, (0.6-12%), 0.5-15% and the balance of deionized water.
4. A method of preparing a female contraceptive antibacterial gel lubricant as claimed in claim 2, wherein: the proportion of the water-soluble chitin derivative, the glycerin and the thickening agent in the component B is 0.6-12 percent to 0.5-12 percent, and the balance is deionized water.
5. A method of preparing a female contraceptive antibacterial gel lubricant as claimed in claim 4, wherein: the water-soluble chitin derivative is one or more of chitosan lactate, chitosan hydrochloride, carboxymethyl chitosan potassium salt or sodium salt, carboxymethyl chitin potassium salt or sodium salt, chitosan acetate and chitosan quaternary ammonium salt.
6. A method of preparing a female contraceptive antibacterial gel lubricant as claimed in claim 4, wherein: the thickening agent comprises cellulose and polypropylene substances.
7. A method of preparing a female contraceptive antibacterial gel lubricant as claimed in claim 6, wherein: the cellulose comprises hydroxymethyl cellulose and hydroxyethyl cellulose.
8. A method of preparing a female contraceptive antibacterial gel lubricant as claimed in claim 6, wherein: the polypropylene includes carbomer and polycarbophil; hyaluronic acid, gelatin.
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112933109A (en) * | 2021-02-03 | 2021-06-11 | 湖南奥朗特医疗器械有限公司 | Vagina pH regulator and preparation method and application thereof |
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CN101172159A (en) * | 2006-10-30 | 2008-05-07 | 上海市计划生育科学研究所 | Acidic biological adhesion heat-variable gelling agent, its preparing method and uses |
CN101559036A (en) * | 2008-04-18 | 2009-10-21 | 上海医药工业研究院 | Conception control gel composition for vagina as well as preparation method and application thereof |
CN101889974A (en) * | 2010-07-12 | 2010-11-24 | 林一文 | Chitosan contraceptive gel and preparation method thereof |
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WO2000015192A1 (en) * | 1998-09-17 | 2000-03-23 | Zonagen, Inc. | Methods and materials related to bioadhesive contraceptive gels |
CN101172159A (en) * | 2006-10-30 | 2008-05-07 | 上海市计划生育科学研究所 | Acidic biological adhesion heat-variable gelling agent, its preparing method and uses |
CN101559036A (en) * | 2008-04-18 | 2009-10-21 | 上海医药工业研究院 | Conception control gel composition for vagina as well as preparation method and application thereof |
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