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CN110840827A - Gynecological antibacterial repair gel and preparation method thereof - Google Patents

Gynecological antibacterial repair gel and preparation method thereof Download PDF

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Publication number
CN110840827A
CN110840827A CN201911252416.1A CN201911252416A CN110840827A CN 110840827 A CN110840827 A CN 110840827A CN 201911252416 A CN201911252416 A CN 201911252416A CN 110840827 A CN110840827 A CN 110840827A
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gel
percent
gynecological
extract
mixture
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胡方
刘明东
仇越秀
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Beijing Happy Regenerative Medical Science And Technology Co Ltd
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Beijing Happy Regenerative Medical Science And Technology Co Ltd
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    • A—HUMAN NECESSITIES
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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
    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract

The invention provides a gynecological antibacterial repair gel and a preparation method thereof, wherein the gynecological antibacterial repair gel is prepared from the following raw materials in percentage by weight: 1 to 10 percent of gel, 0.01 to 6 percent of antibacterial agent, 0.1 to 6 percent of bioactive silicon, 2 to 20 percent of nursing component, 0.1 to 15 percent of dispersant, 0.1 to 1 percent of pH regulator and the balance of water.

Description

Gynecological antibacterial repair gel and preparation method thereof
Technical Field
The invention relates to a gynecological antibacterial repair gel and a preparation method thereof, in particular to a gynecological antibacterial repair gel containing a gel, an antibacterial agent, a nursing component, bioactive silicon, a dispersing agent, a pH regulator and a touch agent and a preparation method thereof.
Background
Gynecological diseases are common diseases of women, and the gynecological diseases can be caused by reasons such as flora imbalance, mucosa damage, microenvironment damage and the like, such as trichomonas vaginitis, bacterial vaginitis and the like, and the gynecological diseases have great influence on the life and work of the women. According to statistics, the incidence rate of various gynecological diseases reaches more than 65%.
The treatment of the gynecological diseases usually combines medication besides relying on autoimmune capability, but the infection is mostly at the surface of mucosa, so the external medication can achieve better effect. The prior gynecological gel can be used for treating various gynecological vaginitis and cervicitis, including bacterial vaginitis, mycotic vaginitis and the like, has good antibacterial effect, but lacks sufficient repairing effect on vaginal erosive tissue wound surfaces. Therefore, there is an urgent need for a gynecological disease treatment drug that can rapidly repair the wound surface and control inflammation.
Disclosure of Invention
The invention provides a gynecological antibacterial repair gel and a preparation method thereof, and aims to treat gynecological diseases such as vaginitis and cervicitis.
The technical scheme adopted by the invention for solving the problems is as follows: the gynecological antibacterial repair gel is prepared from the following raw materials in percentage by weight:
1 to 10 percent of gel agent,
0.01 to 6 percent of antibacterial agent,
0.1 to 6 percent of biological active silicon,
2 to 20 percent of nursing component, 0.1 to 15 percent of dispersant,
0.1 to 1 percent of pH regulator and the balance of water.
In the raw material formula of the repair gel, various components are cooperated with each other, so that the control of inflammation and the rapid repair of wound surfaces are realized. Wherein the gel is mainly used for supporting and slowly releasing, so that the gel is firmly fixed on the affected part in a proper time and plays a curative effect; the antibacterial agent is mainly used for playing the roles of sterilizing and relieving itching, and simultaneously lays a good environmental foundation for the repair of the wound surface by the bioactive silicon. The bioactive silicon is uniformly dispersed in the gel, so that the overall repair of the wound surface is promoted, and if the dosage of the bioactive silicon is too large, the gel can be denatured; the nursing components provide good gynecological environment and nutrients for repairing wound surfaces, and if the dosage of the nursing components is too large, side effects such as stimulation and the like can be generated. The gel matrix is pre-dispersed by the dispersing agent so as to be fully swelled; the pH regulator maintains the pH value of the gel at proper acidity, and is favorable for maintaining the vaginal environment and exerting the curative effect of the gel preparation.
In the invention, the bioactive silicon has the function of promoting tissue repair, but the simple application of the bioactive silicon to the wound surface cannot ensure the uniform dispersion, and the bioactive silicon lacks the adhesiveness, can be quickly washed away from the wound surface and cannot completely play a role. The simple gel matrix only has the adhesive effect and has no sterilization and repair effects, but can be used as a carrier for uniformly dispersing the antibacterial agent and the bioactive silicon in the gel matrix, adhering the gel matrix to the wound surface and slowly releasing the antibacterial agent and the bioactive silicon to the wound surface, thereby fully playing the roles of sterilization and repair promotion.
In the above gynecological antibacterial repair gel, as a preferred embodiment, the raw materials further include: 0.01-1% of touch feeling agent.
In the above gynecological antibacterial repair gel, as a preferred embodiment, the raw materials for preparing the gynecological antibacterial repair gel comprise, by weight: 2.0-4.0 percent of gel, 0.1-5 percent of antibacterial agent, 0.2-5 percent of bioactive silicon, 5-15 percent of nursing component, 0.8-15 percent of dispersing agent, 0.1-0.8 percent of pH regulator, 0.01-0.5 percent of touch feeling agent and the balance of water.
In the above gynecological antibacterial repair gel, as a preferred embodiment, the raw materials for preparing the gynecological antibacterial repair gel comprise, by weight: 2.5 to 3.5 percent of gel, 0.3 to 5 percent of antibacterial agent, 0.5 to 5 percent of bioactive silicon, 5 to 15 percent of nursing component, 1 to 15 percent of dispersing agent, 0.1 to 0.8 percent of pH regulator, 0.01 to 0.2 percent of touch feeling agent and the balance of water.
In the above gynecological antibacterial repair gel, as a preferred embodiment, the raw materials for preparing the gynecological antibacterial repair gel in percentage by weight include: 2 to 3 percent of gel, 0.5 to 1.5 percent of antibacterial agent, 0.3 to 1 percent of bioactive silicon, 5 to 15 percent of nursing component, 5 to 15 percent of dispersing agent, 0.5 to 1 percent of pH regulator, 0.1 to 0.15 percent of touch feeling agent and the balance of water.
In the gynecological antibacterial repair gel, as a preferred embodiment, the gelling agent is any one or a mixture of more of hydroxyethyl cellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, carbomer, xanthan gum, sodium alginate, carrageenan and guar gum, and the gelling agent of the invention includes, but is not limited to, the gelling agents mentioned above, and can also include other gelling agents with similar efficacy.
In the gynecological antibacterial repair gel, as a preferred embodiment, the antibacterial agent is any one or a mixture of several of chitosan (preferably carboxymethyl chitosan), chlorhexidine acetate, nano silver, povidone iodine and triclosan. The antibacterial agent of the present invention includes, but is not limited to, the above-mentioned antibacterial agents, and may also include other antibacterial agents having similar effects.
In the above gynecological antibiotic repair gel, as a preferred embodiment, the bioactive silicon is an oxide comprising 40-70 wt% of silicon dioxide and 30-60 wt% of phosphorus, calcium and sodium; wherein the silicon dioxide forms a three-dimensional network structure, and calcium ions and phosphorus ions are orderly distributed among three-dimensional network silicon atoms; wherein the 5-valent silicon atom and/or the 6-valent silicon atom accounts for 1 mol% to 10 mol% of the total silicon atoms; the content of phosphorus oxide is 2-5 wt%. The content of the calcium oxide in the regenerated silicon material is preferably 10 to 20 wt%. The content of the sodium oxide is preferably 10 to 20 wt%. The bioactive silicon of the present invention can be prepared according to the method described in the patent application with the publication number of CN106362214A, and the commercial Regesi regenerated silicon produced by Beijing Happy probiotic high and new technology company Limited can also be adopted, and the Regesi regenerated silicon of any type of the product can be used in the present invention. The material is made of SiO2、CaO、P2O5The formed Regesi regenerated silicon is solid powder, has huge specific surface area and stable pH after contacting body fluid. The bioactive silicon can also be a regenerated silicon material-POSS-based regenerated medical material prepared by the method disclosed in the Chinese patent publication No. CN109771692A, and the material is a product obtained by calcining polyhedral oligomeric silsesquioxane to remove organic components, so as to form a polyhedral cage-shaped structure consisting of Si-O-Si bonds in silicon oxide as a frame, and a novel bioactive material in which calcium and phosphorus elements are embedded.
In the gynecological antibacterial repair gel, as a preferred embodiment, the nursing component is any one or more of centella asiatica extract, cactus extract, oriental cherry extract, arbutin, ginkgo biloba extract, collagen, sodium hyaluronate, ginseng extract, aloe extract, motherwort extract, avenanthramide, peony extract, snow lotus extract, witch hazel extract, moutan bark extract, licorice extract, tocopherol, corn alcohol, oligopeptide, propolis, and sophora flavescens.
In the gynecological antibacterial repair gel, as a preferred embodiment, the dispersant is any one or a mixture of more of propylene glycol, glycerol, polyethylene glycol, tween-80 and absolute ethyl alcohol.
In the gynecological antibacterial repair gel, as a preferred embodiment, the pH regulator is any one or a mixture of several of citric acid, triethanolamine, dihydrogen phosphate (preferably sodium salt or potassium salt), and lactic acid.
In the gynecological antibacterial repair gel, as a preferred embodiment, the touch feeling agent is one or a mixture of more of borneol, menthol, N,2, 3-trimethyl-2-isopropyl butanamide and vanillyl butyl ether.
The antibacterial agents such as chitosan, chlorhexidine acetate and the like have good antibacterial property and biocompatibility, do not have irritation or toxic or side effect, have certain effect on various pathogenic microorganisms in the vagina, can ensure the balance of flora in the vagina, have good treatment effect on bacterial vaginal diseases, trichomonas vaginal diseases, cervical erosion and other gynecological diseases, and also lay a good foundation for repairing damaged tissues. The bioactive silicon can promote the generation of growth factors and the proliferation of cells, and is the only material capable of forming chemical bonding with bone tissues and forming bonding effect with soft tissues. The caring components (such as collagen, Aloe, herba Adonidis extract, and radix et caulis Opuntiae Dillenii) can create good gynecological environment, and can provide sufficient nutrients to promote tissue repair.
A preparation method of gynecological antibacterial repair gel comprises the following steps:
(1) weighing the components according to the raw materials and the percentage thereof in the gynecological antibacterial repair gel for later use;
(2) dispersing the gel into partial dispersant, and stirring uniformly to obtain pre-dispersed gel for later use;
(3) dissolving the antibacterial agent and the care type components in water, fully stirring, adding into the pre-dispersed gel, and fully stirring to obtain a gel-like mixture;
(4) dispersing bioactive silicon and a tactility agent in a dispersing agent, and then adding the first mixture obtained in the step (3) to obtain a second mixture;
(5) adding a proper amount of pH regulator into the second mixture, regulating the pH to 3.5-7.5, preferably 4.0-5.5, standing and defoaming to obtain gynecological antibacterial repair gel;
preferably, part of the dispersant in the step (2) is 1/2-2/3 of the total formula amount of the dispersant;
preferably, step (4) is: dispersing both the tactile agent and the bioactive silicon in the remaining amount of the dispersion according to the formula of claim 2, and then adding the first mixture of step (3) to obtain a second mixture.
The invention has the beneficial effects that: compared with the prior art, the gynecological antibacterial repair gel prepared by the invention can inhibit and kill pathogenic bacteria, promote the wound repair capability, improve the healing speed of the wound, shorten the repair time and create a good gynecological environment. Also has antibacterial and antipruritic effects.
Drawings
FIG. 1 is a diagram of vaginal tissues of an experimental white rat under different treatment conditions; wherein, FIG. 1a is a diagram of vaginal tissue of a white rat in a normal experiment, and FIG. 1b is a diagram of vaginal tissue of a rat which is successfully molded but is not treated; FIG. 1c is a diagram of vaginal tissue of a rat that was successfully molded and vaginally administered with the gynecological antibacterial repair gel of comparative example 1 for 3 days, and FIG. 1d is a diagram of vaginal tissue of a rat that was successfully molded and vaginally administered with the gynecological antibacterial repair gel of comparative example 1 for 7 days; FIG. 1e is a diagram of vaginal tissue of rats successfully molded and vaginally administered with the gynecological antibacterial repair gel of example 6 for 3 days, and FIG. 1f is a diagram of vaginal tissue of rats successfully molded and vaginally administered with the gynecological antibacterial repair gel of example 6 for 7 days.
Detailed Description
For a further understanding of the invention, reference will now be made to the following examples, which are included to provide a further understanding of the invention, and are intended to be purely exemplary of the invention, rather than to be exhaustive of the invention. 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 gynecological antibacterial repair gel is prepared from the following raw materials in percentage by weight: 1 to 10 percent of gel, 0.01 to 6 percent of antibacterial agent, 0.1 to 6 percent of bioactive silicon, 2 to 20 percent of nursing component, 0.1 to 15 percent of dispersant, 0.1 to 1 percent of pH regulator and the balance of water.
The gel is selected from one or more of hydroxyethyl cellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, carbomer, xanthan gum, sodium alginate, carrageenan and guar gum.
The antibacterial agent is selected from one or more of chitosan, chlorhexidine acetate, nano silver, povidone iodine and triclosan.
The protective agent component is selected from one or more of herba Centellae extract, radix et caulis Opuntiae Dillenii extract, Oriental cherry blossom extract, arbutin, semen Ginkgo extract, collagen, sodium hyaluronate, Ginseng radix extract, Aloe extract, herba Leonuri extract, avenanthramide alkaloid, radix Paeoniae extract, herba Saussureae Involueratae extract, radix Hamamelis mollis extract, cortex moutan extract, Glycyrrhrizae radix extract, tocopherol, zein, oligopeptide, propolis, and radix Sophorae Flavescentis. Preferably, the nursing components comprise the following components in percentage by weight based on the total amount of raw materials for preparing the gynecological antibacterial repair gel: 1 to 3 percent of collagen, 0.05 to 1 percent of sodium hyaluronate, 0.05 to 1 percent of ginseng extract, 0.3 to 2 percent of ginkgo extract, 0.3 to 2 percent of motherwort extract, 0.5 to 4 percent of aloe extract, 0.1 to 5 percent of centella extract, 0.3 to 3.5 percent of arbutin, 0.05 to 3 percent of liquorice extract and 0.5 to 3 percent of cactus extract.
The care components of the invention are all products which can be used in the medical, health care or cosmetic industries.
The centella asiatica extract used in the present invention preferably has a triterpene total saponin content of 10 to 20% as measured by HPLC; the centella asiatica extract which is produced by Jianxi Jiahe biotechnology limited company and is numbered JHS-008 is adopted in the embodiment of the invention, and the content of the triterpenoid total saponin is 10 percent.
The cactus extract used in the present invention preferably has a flavone content of 5.0% or more as measured by UV; the cactus extract which is produced by Jianxi Jiahe biotechnology limited company and is numbered JHS-130 is adopted in the embodiment of the invention, and the flavone content is 5.0 percent.
The ginseng extract used in the present invention, preferably, wherein the ginsenoside content is 5.0-80.0% by UV detection; the embodiment of the invention adopts ginseng extract which is produced by Jianxi Jiahe biological science and technology Limited company and has the number of JHY-077, and the content of ginsenoside is 20 percent.
The aloe extract used in the present invention preferably has an aloe-emodin content of 95.0% or more as determined by HPLC; the aloe extract with the number of JHS-062 produced by Jianxi Jiahe biological science and technology Limited company is adopted in the embodiment of the invention, and the content of aloe-emodin is 9 percent.
The cherry extract used in the present invention may be a fine powder obtained by extracting a flower of Japanese cherry belonging to the family Rosaceae with purified water, concentrating under reduced pressure, and spray-drying, and contains sakuranetin and sakuranetin, and may be prepared by a method comprising the following steps: 1, oriental cherry extract.
The quality control of the ginkgo extract used in the invention is shown in the 2015 edition of Chinese pharmacopoeia, and the ginkgo extract produced by the pharmaceutical chemical company Limited in Qifei lake is used in the embodiment of the invention.
The herba leonuri extract used in the present invention may be a herba leonuri extract produced by the West Anchang Yue plant chemical Co., Ltd, which has a stachydrine hydrochloride content of 4%.
The main component of the peony extract used in the invention is paeoniflorin, the content of which is more than 20% (detected by HPLC), and the peony extract with the content of 20% produced by Sianenbao biotechnology limited is used in the embodiment of the invention.
The main component of the licorice extract used in the invention is glycyrrhizic acid, the content of which is more than 20% (detected by adopting a gravimetric method), and the licorice extract with the glycyrrhizic acid content of 20% produced by the sienna clover biotechnology limited is used in the embodiment of the invention.
The snow lotus herb extract used in the invention mainly comprises snow lotus polysaccharide with the content of 10-98% (detected by HPLC), and the snow lotus herb extract with the content of 20% produced by Vant Wallace biological company of Lanzhou is used in the embodiment of the invention.
The witch hazel extract used in the invention has the main component of witch hazel tannin with the content of more than 20% (by adopting UV detection), and the witch hazel extract with the content of 20% of the witch hazel tannin produced by the Western-Ancheng-Cheng-Biotech limited is used in the embodiment of the invention.
The main component of the moutan bark extract used in the invention is paeonol with the content of more than 30% (by adopting UV detection), and the moutan bark extract with the paeonol content of 30% produced by Shaanxi Sinot biotechnology limited is used in the embodiment of the invention.
The care component may be in powder, liquid or other form. The dispersant is selected from one or more of propylene glycol, glycerol, polyethylene glycol, tween-80 and anhydrous alcohol.
The pH regulator is one or more selected from citric acid, triethanolamine, dihydrogen phosphate, and lactic acid.
The touch feeling agent is one or more of borneol, menthol, N,2, 3-trimethyl-2-isopropyl butanamide and vanillyl butyl ether.
A preparation method of gynecological antibacterial repair gel comprises (1) weighing raw materials of each component according to a formula for use;
(1) weighing the components according to the raw materials and the percentages thereof for later use;
(2) dispersing the gel into 2/3 dispersant, and stirring to obtain pre-dispersed gel for use;
(3) dissolving the antibacterial agent and the care type components in water, fully stirring, adding into the pre-dispersed gel, and fully stirring to obtain a gel-like mixture;
(4) dispersing the bioactive silicon and the tactility agent in the remaining 1/3 dispersing agent, and then adding the first mixture obtained in the step (3) to obtain a second mixture;
(5) and adding a proper amount of pH regulator into the second mixture, regulating the pH to 3.5-7.5, standing and defoaming to obtain the gynecological antibacterial repair gel.
Example 1
Weighing the following raw materials according to the following mass formula: chlorhexidine acetate 0.3%, hydroxypropyl methylcellulose 2.5%, glycerol 6%, bioactive silicon 0.5% (commercial Regesi regenerated silicon V type produced by beijing happy probiotic high and new technology limited), nursing component 6%, citric acid 0.1%, borneol 0.1%, and the balance water. Wherein, based on the total amount of the gel raw materials, the nursing components are specifically composed of the following components: ginkgo biloba extract 1%, ginseng extract 0.2%, motherwort herb extract 0.5%, aloe vera extract 2%, centella asiatica extract 0.5%, arbutin 0.5%, licorice extract 0.3%, cactus extract 1%.
Firstly, dispersing hydroxypropyl methyl cellulose in 2/3 glycerol to obtain a pre-dispersed gel for later use. Then dissolving the antibacterial agent chlorhexidine acetate and the nursing component in water with the formula amount, stirring and dissolving, adding into the pre-dispersed gel, and stirring into gel to obtain a first mixture. Dispersing the bioactive silicon and the borneol into the remaining 1/3 glycerol, then adding the first mixture to obtain a second mixture, then adding citric acid and stirring uniformly, and standing and defoaming at normal temperature to obtain the gynecological antibacterial repair gel.
Example 2
Weighing the following raw materials according to the following mass formula: chlorhexidine acetate 0.3%, hydroxyethyl cellulose 3%, glycerol 9%, bioactive silicon 2% (commercial Regesi regenerated silicon V type produced by beijing happy probiotic high and new technology limited), nursing component 6%, citric acid 0.4%, borneol 0.1%, and the balance water. Wherein, the nursing components comprise the following components: ginkgo biloba extract 1%, ginseng extract 0.2%, motherwort herb extract 0.5%, aloe vera extract 2%, centella asiatica extract 0.5%, arbutin 0.5%, licorice extract 0.3%, cactus extract 1%.
Firstly, hydroxyethyl cellulose is dispersed in glycerol of 2/3 to obtain a pre-dispersed gel for later use. Then dissolving the antibacterial agent chlorhexidine acetate and the nursing component in water with the formula amount, stirring and dissolving, adding into the pre-dispersed gel, and stirring into gel to obtain a first mixture. Dispersing the bioactive silicon and the borneol into the remaining 1/3 glycerol, then adding the first mixture to obtain a second mixture, then adding citric acid and stirring uniformly, and standing and defoaming at normal temperature to obtain the gynecological antibacterial repair gel.
Example 3
Weighing the following raw materials according to the following mass formula: chlorhexidine acetate 0.3%, hydroxypropyl methylcellulose 2.5%, glycerol 10%, bioactive silicon 1.5% (commercial Regesi regenerated silicon V type produced by beijing happy probiotic high and new technology limited), nursing component 6%, citric acid 0.3%, borneol 0.1%, and the balance water. Wherein, the nursing components comprise the following components: ginkgo biloba extract 1%, ginseng extract 0.2%, motherwort herb extract 0.5%, aloe vera extract 2%, centella asiatica extract 0.5%, arbutin 0.5%, licorice extract 0.3%, cactus extract 1%.
Firstly, dispersing hydroxypropyl methyl cellulose in 2/3 glycerol to obtain a pre-dispersed gel for later use. Then dissolving the antibacterial agent chlorhexidine acetate and the nursing component in water with the formula amount, stirring and dissolving, adding into the pre-dispersed gel, and stirring into gel to obtain a first mixture. Dispersing the bioactive silicon and the borneol into the remaining 1/3 glycerol, then adding the first mixture to obtain a second mixture, then adding citric acid and stirring uniformly, and standing and defoaming at normal temperature to obtain the gynecological antibacterial repair gel.
Example 4
Weighing the following raw materials according to the following mass formula: 1.8 percent of carboxymethyl chitosan, 2.5 percent of hydroxypropyl methyl cellulose, 6 percent of propylene glycol, 1 percent of bioactive silicon (commercial Regesi regenerated silicon V type produced by Beijing Happy probiotic high and new technology Co., Ltd.), 9 percent of nursing component, 0.4 percent of potassium dihydrogen phosphate, 0.1 percent of borneol, 0.05 percent of menthol and the balance of water. Wherein, the nursing components comprise the following components: 2% of collagen, 0.15% of sodium hyaluronate, 0.2% of ginseng extract, 0.5% of ginkgo biloba extract, 3% of aloe extract, 0.5% of centella extract, 0.5% of arbutin, 0.15% of licorice extract and 2% of cactus extract.
Firstly, dispersing hydroxypropyl methyl cellulose in 2/3 propylene glycol to obtain a pre-dispersed gel for later use. Then dissolving the antibacterial agent carboxymethyl chitosan and the care components in water with the formula amount, stirring and dissolving, adding into the pre-dispersed gel, and stirring to form gel, thus obtaining a first mixture. Dispersing the bioactive silicon, the borneol and the menthol into the remaining 1/3 propylene glycol, then adding the first mixture to obtain a second mixture, then adding the monopotassium phosphate, uniformly stirring, standing at normal temperature for defoaming, and obtaining the gynecological antibacterial repair gel.
Example 5
Weighing the following raw materials according to the following mass formula: 1.8 percent of carboxymethyl chitosan, 2 percent of hydroxyethyl cellulose, 8 percent of propylene glycol, 2 percent of bioactive silicon (a commercial Regesi regenerated silicon V type produced by Beijing Happy probiotic high and new technology Co., Ltd.), 9 percent of nursing component, 0.6 percent of monopotassium phosphate, 0.1 percent of borneol, 0.05 percent of menthol and the balance of water. Wherein, the nursing components comprise the following components: 2% of collagen, 0.15% of sodium hyaluronate, 0.2% of ginseng extract, 0.5% of ginkgo biloba extract, 3% of aloe extract, 0.5% of centella extract, 0.5% of arbutin, 0.15% of licorice extract and 2% of cactus extract.
Firstly, hydroxyethyl cellulose is dispersed in propylene glycol of 2/3 to obtain a pre-dispersed gel for later use. Then, the antibacterial agent carboxymethyl chitosan and the care components are dissolved in water with the formula amount, stirred and dissolved, added into the pre-dispersed gel, and stirred into gel, so as to obtain a first mixture. Dispersing the bioactive silicon, the borneol and the menthol into the remaining 1/3 propylene glycol, then adding the first mixture solution to obtain a second mixture, then adding the monopotassium phosphate, uniformly stirring, and standing at normal temperature for defoaming to obtain the gynecological antibacterial repair gel.
Example 6
Weighing the following raw materials according to the following mass formula: 1.8 percent of carboxymethyl chitosan, 2.5 percent of sodium carboxymethyl cellulose, 10 percent of propylene glycol, 0.5 percent of bioactive silicon (a commercial Regesi regenerated silicon V type produced by Beijing Happy probiotic high and new technology Co., Ltd.), 9 percent of nursing component, 0.2 percent of potassium dihydrogen phosphate, 0.1 percent of borneol, 0.05 percent of menthol and the balance of water. Wherein, the nursing components comprise the following components: 2% of collagen, 0.15% of sodium hyaluronate, 0.2% of ginseng extract, 0.5% of ginkgo biloba extract, 3% of aloe extract, 0.5% of centella extract, 0.5% of arbutin, 0.15% of licorice extract and 2% of cactus extract.
Firstly, dispersing sodium carboxymethylcellulose in 2/3 propylene glycol to obtain a pre-dispersed gel for later use. Then dissolving the antibacterial agent carboxymethyl chitosan and the care components in water with the formula amount, stirring and dissolving, adding into the pre-dispersed gel, and stirring to form gel, thus obtaining a first mixture. Dispersing the bioactive silicon, the borneol and the menthol into the remaining 1/3 propylene glycol, then adding the first mixture to obtain a second mixture, then adding the monopotassium phosphate, uniformly stirring, and standing and defoaming at normal temperature to obtain the gynecological antibacterial repair gel.
Comparative example 1
Weighing the following raw materials according to the following mass formula: 1.8 percent of carboxymethyl chitosan, 2.5 percent of sodium carboxymethyl cellulose, 10 percent of propylene glycol, 9 percent of nursing component, 0.05 percent of potassium dihydrogen phosphate, 0.1 percent of borneol, 0.05 percent of menthol and the balance of water. Wherein, the nursing components comprise the following components: 2% of collagen, 0.15% of sodium hyaluronate, 0.2% of ginseng extract, 0.5% of ginkgo biloba extract, 3% of aloe extract, 0.5% of centella extract, 0.5% of arbutin, 0.15% of licorice extract and 2% of cactus extract.
Firstly, dispersing sodium carboxymethylcellulose in 2/3 propylene glycol to obtain a pre-dispersed gel for later use. Then, the antibacterial agent carboxymethyl chitosan and the nursing ingredients are dissolved in water according to the formula amount, stirred and dissolved, added into the pre-dispersed gel, and stirred into gel, so as to obtain a first mixture. Dispersing borneol and menthol in the remaining 1/3 propylene glycol, then adding the first mixture to obtain a second mixture, then adding monopotassium phosphate, uniformly stirring, standing at normal temperature for defoaming, and obtaining the gynecological antibacterial repair gel.
Product performance detection
Firstly, bacteriostatic experiment:
the test method comprises the following steps: the gynecological antibacterial repair gel prepared in the embodiments 1-6 of the invention is subjected to a bacteriostasis test to test the bacteriostasis effect of the gel on escherichia coli, staphylococcus aureus and candida albicans. The experiment for bacteriostasis is referred to disinfection technical Specification (2002 edition).
The results of the experiment are shown in table 1.
TABLE 1 bacteriostatic experiments
Figure BDA0002309394520000101
Figure BDA0002309394520000111
According to the evaluation standard specified in GB 15979-2002-supplement C4, the bacteriostatic rate is more than or equal to 50-90%, the product has the bacteriostatic action, the bacteriostatic rate is more than or equal to 90%, and the product has strong bacteriostatic action.
Therefore, the gynecological antibacterial repair gel prepared by the invention has a strong bacteriostatic action.
II, animal experiments:
(a) experimental animals: the method comprises the following steps of adaptively feeding a female non-pregnant (Wistar or SD) white rat with the body mass of 170-240 g for 1 week and carrying out ordinary-grade feeding.
(b) Molding: the prepared 25% phenol mucilage liquid medicine (formula: 5g phenol, 15g Arabic gum, 20ml distilled water, complete dissolution at 37 ℃ to prepare mucilage, use in preparation now) is extracted by a 1ml disposable syringe, the liquid medicine is injected into the vagina of a rat with the depth of about 1cm (the action needs to be gentle and slow) according to the dosage of 0.15ml for each rat, a self-made medical sterile cotton strip is used for blocking the vaginal orifice to prevent the liquid medicine from flowing out, the times are 1/2 days and 5 times, wherein, the change of the vagina of the rat is observed by naked eyes in the molding process, most of the vagina of the rat is congested and swollen by congestion and exudation of white secretion after molding for 4 times, which indicates that the molding is successful, and the molding is continued for 1 time.
(c) Grouping and administration: on the day of successful model building, 30 successfully modeled rats were randomly divided into 3 groups, which were grouped in the following table, and a normal group, i.e., a female infertile rat without any treatment, was set.
The experimental group 1 was prepared from vaginal tissues (6) of a normal experimental white rat, the experimental group 2 was prepared from vaginal tissues (6) of a rat which was successfully molded but was not treated, the experimental group 3 was prepared from vaginal tissues of a rat which was successfully molded and was administered with the gel of comparative example 1 for 3 days and 7 days, that is, vaginal tissues (6) of a rat were prepared once after 3 days of administration of the gynecological antibacterial repairing gel of comparative example 1, vaginal tissues (6) of a rat were prepared once for 7 days, the experimental group 4 was prepared from vaginal tissues of a rat which was successfully molded and was administered with the gynecological antibacterial repairing gel of example 6 for 3 days and 7 days, that is, vaginal tissues (6) of a rat were prepared once for 3 days of administration of the gynecological antibacterial repairing gel of example 6, and vaginal tissues (6) of a rat were prepared once for 7 days.
Experimental group 1 Experimental group 2 Experimental group 3 Experimental group 4
Normal group Molding set Comparative example 1 Example 6
6 are 6 are 12 pieces of 12 pieces of
(d) Material taking: according to the requirements of each group, 24 hours after the last administration, the rats are immediately killed, tissues from the vagina to the corner of the uterus (namely the vaginal tissues) are taken, the taken vaginal tissues are placed in 10% formaldehyde solution for soaking and fixing for 24 hours, materials are immediately taken, dehydrated, embedded in paraffin, sliced (5um), and subjected to HE staining routine histopathology examination.
(e) The experimental results are as follows: as shown in fig. 1, when bioactive silicon is not added (comparative example 1), that is, when the gynecological antibacterial repair gel of comparative example 1 is used for drug delivery to vaginal tissue of a rat with successful modeling, after 3 days of drug delivery, a large amount of erosive tissue still exists on the vaginal wound of the rat (shown in fig. 1 c), and after 7 days of drug delivery (shown in fig. 1 d), the vaginal tissue of the normal rat is approached; when the bioactive silicon is added (example 6), namely when the gynecological antibacterial repair gel of example 6 is used for drug delivery to vaginal tissues of rats successfully molded, after 3 days of drug delivery, the vaginal tissues of the rats (shown in figure 1 e) have no difference with the vaginal tissues of normal rats (shown in figure 1 a), which indicates that the bioactive silicon has an excellent promoting effect on vaginal wound repair.
Third, clinical trial
(a) Patient information: 200 patients are all gynecological outpatient cervical erosion patients, have no other diseases, are not treated by any medicament, and have the age of 20-45 years.
(b) The treatment method comprises the following steps: the patient injects the gynecological antibacterial repair gel prepared in the embodiment 6 of the invention into the deep vagina every night, 1 time every day, 3g every time, and 10 consecutive days are 1 course of treatment.
(c) Diagnosis standard of cervical erosion:
mild erosion: the cervical erosion surface is less than 1/3 of the total cervical area.
Moderate erosion: the cervical erosion surface accounts for 1/3-2/3 of the whole cervical area.
Severe erosion: the cervical erosion surface is greater than 2/3 of the total cervical area.
(d) And (3) evaluating the curative effect:
and (3) curing: the erosion face is completely repaired, and the cervix becomes smooth;
the method has the following advantages: the erosion surface is reduced by over 1/3;
and (4) invalidation: the erosion surface is not changed.
(e) The treatment results are as follows: after 200 patients are treated, the total effective rate reaches 100 percent and the total cure rate reaches 99.5 percent after two treatment courses, and the treatment effect and the wound healing time are detailed in tables 2 and 3.
TABLE 2 therapeutic effect of gynecological antibacterial repairing gel prepared by the present invention on cervical erosion
Figure BDA0002309394520000121
Figure BDA0002309394520000131
TABLE 3 wound healing time
Figure BDA0002309394520000132

Claims (10)

1. The gynecological antibacterial repair gel is characterized in that the gynecological antibacterial repair gel is prepared from the following raw materials in percentage by weight: 1 to 10 percent of gel, 0.01 to 6 percent of antibacterial agent, 0.1 to 6 percent of bioactive silicon, 2 to 20 percent of nursing component, 0.1 to 15 percent of dispersant, 0.1 to 1 percent of pH regulator and the balance of water.
2. The gynecological antimicrobial repair gel according to claim 1, wherein the raw materials further comprise: 0.01-1% of touch feeling agent;
preferably, the gynecological antibacterial repair gel is prepared from the following raw materials in percentage by weight: 2.0-4.0 percent of gel, 0.1-5 percent of antibacterial agent, 0.2-5 percent of bioactive silicon, 5-15 percent of nursing component, 0.8-15 percent of dispersing agent, 0.1-0.8 percent of pH regulator, 0.01-0.5 percent of touch feeling agent and the balance of water.
3. The gynecological antibacterial repair gel according to claim 2, characterized in that the raw materials for preparing the gynecological antibacterial repair gel comprise, in weight percent: 2.5-3.5% of gel, 0.3-5% of antibacterial agent, 0.5-5% of bioactive silicon, 5-15% of nursing component, 1-15% of dispersing agent, 0.1-0.8% of pH regulator, 0.01-0.2% of touch feeling agent and the balance of water;
preferably, the gynecological antibacterial repair gel is prepared from the following raw materials in percentage by weight: 2 to 3 percent of gel, 0.5 to 1.5 percent of antibacterial agent, 0.3 to 1 percent of bioactive silicon, 5 to 15 percent of nursing component, 5 to 15 percent of dispersing agent, 0.5 to 1 percent of pH regulator, 0.1 to 0.15 percent of touch feeling agent and the balance of water.
4. The gynecological antimicrobial repair gel of claim 1, wherein: the gel is one or a mixture of more of hydroxyethyl cellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, carbomer, xanthan gum, sodium alginate, carrageenan and guar gum; preferably, the antibacterial agent is any one or a mixture of several of chitosan, chlorhexidine acetate, nano-silver, povidone iodine and triclosan, and preferably, the chitosan is carboxymethyl chitosan.
5. The gynecological antimicrobial repair gel of claim 1, wherein: the nursing component is any one or more of centella extract, cactus extract, oriental cherry extract, arbutin, ginkgo biloba extract, collagen, sodium hyaluronate, ginseng extract, aloe extract, motherwort extract, avenanthramide alkaloid, peony extract, snow lotus extract, witch hazel extract, moutan bark extract, licorice extract, tocopherol, corn alcohol, oligopeptide, propolis and sophora flavescens.
6. The gynecological antimicrobial repair gel of claim 1, wherein: the dispersant is one or a mixture of more of propylene glycol, glycerol, polyethylene glycol, tween-80 and absolute ethyl alcohol;
preferably, the pH regulator is one or a mixture of more of citric acid, lactic acid, triethanolamine and dihydric phosphate; preferably, the dihydrogen phosphate is sodium dihydrogen phosphate or potassium dihydrogen phosphate.
7. The gynecological antimicrobial repair gel of claim 1, wherein: the bioactive silicon is as follows: comprising 40-70 wt% silica and 30-60 wt% of an oxide selected from the group consisting of phosphorus, calcium and sodium; wherein the silicon dioxide forms a three-dimensional network structure, and calcium ions and phosphorus ions are orderly distributed among three-dimensional network silicon atoms; wherein the 5-valent silicon atom and/or the 6-valent silicon atom accounts for 1 mol% to 10 mol% of the total silicon atoms; the content of phosphorus oxide is 2-5 wt%; the content of the calcium oxide in the bioactive silicon is preferably 10-20 wt%, and the content of the sodium oxide in the bioactive silicon is preferably 10-20 wt%; or the bioactive silicon is Regesi regenerated silicon.
8. The gynecological antimicrobial repair gel of claim 2, wherein: the touch feeling agent is one or a mixture of more of borneol, menthol, N,2, 3-trimethyl-2-isopropyl butanamide and vanillyl butyl ether.
9. The gynecological antimicrobial repair gel of claim 1, wherein: the gynecological antibacterial repair gel is prepared by the following steps:
(1) weighing the components according to the raw materials and the percentages thereof in the claim 1 for later use;
(2) dispersing the gel into partial dispersant, and stirring uniformly to obtain pre-dispersed gel for later use;
(3) dissolving the antibacterial agent and the nursing components in water, fully stirring, adding into the pre-dispersed gel, and fully stirring into gel to obtain a first mixture;
(4) dispersing the bioactive silicon in the rest dispersing agent, and then adding the first mixture in the step (3) to obtain a second mixture;
(5) adding a pH regulator into the second mixture, regulating the pH to 3.5-7.5, preferably 4.0-5.5, standing and defoaming to obtain the gynecological antibacterial repair gel;
preferably, part of the dispersant in the step (2) is 1/2-2/3 of the total formula amount of the dispersant;
preferably, step (4) is: dispersing both the tactile agent and the bioactive silicon in the remaining amount of the dispersion according to the formula of claim 2, and then adding the first mixture of step (3) to obtain a second mixture.
10. A process for the preparation of a gynecological antibacterial repair gel according to any one of claims 1 to 8, characterized in that: the method comprises the following steps:
(1) weighing the raw materials and the percentage thereof according to the claims 1 to 8 for later use;
(2) dispersing the gel into partial dispersant, and stirring uniformly to obtain pre-dispersed gel for later use;
(3) dissolving the antibacterial agent and the nursing components in water, fully stirring, adding into the pre-dispersed gel, and fully stirring into gel to obtain a first mixture;
(4) dispersing the bioactive silicon in the rest dispersing agent, and then adding the first mixture in the step (3) to obtain a second mixture;
(5) adding a pH regulator into the second mixture, regulating the pH to 3.5-7.5, preferably 4.0-5.5, standing and defoaming to obtain the gynecological antibacterial repair gel;
preferably, part of the dispersant in the step (2) is 1/2-2/3 of the total formula amount of the dispersant;
preferably, step (4) is: dispersing both the tactile agent and the bioactive silicon in the remaining amount of the dispersion according to the formula of claim 2, and then adding the first mixture of step (3) to obtain a second mixture.
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