CN114588253B - Pharmaceutical composition for repairing and preventing vaginal mucosa aging and preparation thereof - Google Patents
Pharmaceutical composition for repairing and preventing vaginal mucosa aging and preparation thereof Download PDFInfo
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Abstract
The invention belongs to the field of medicines, and particularly relates to a vaginal pharmaceutical composition which comprises collagen having a protective effect on vaginal mucosa, a vaginal pathogenic microorganism inhibitor natural flavonoid compound, prebiotics for promoting the growth of vaginal probiotics and schizophyllan for improving the immunity of the organism and maintaining the local anti-infection capability of the vagina. The invention also relates to a pharmaceutical preparation for vagina, which is gel, ointment, foam, suppository, tablet, hard capsule and soft capsule for vagina. The invention also relates to the application of the pharmaceutical composition or the pharmaceutical preparation in preparing medicines for restoring the internal environment of the vagina, repairing the vaginal mucosa, treating vaginitis and preventing the occurrence and the recurrence of vaginitis.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a vaginal pharmaceutical composition, a preparation and an application thereof. In particular, the pharmaceutical composition of the present invention is used for restoring the internal environment of the vagina, repairing the vaginal mucosa, treating vaginitis caused by bacteria, fungi or viruses, and preventing the occurrence and recurrence of vaginitis.
Background
Vaginitis is a common disease in gynecological outpatient service, affects physical and psychological health of women, is mostly related to vaginal microecological imbalance of patients, and has poor treatment effect and high recurrence rate. The main pathological changes are dysbacteriosis in the vagina, namely, the dysbacteriosis of microecology which is normally parasitized in the vagina, the decrease of beneficial bacteria such as lactobacillus in the vagina and the like and the mass propagation of other pathogenic bacteria, the propagation of anaerobic bacteria and the like generate amine substances at the same time, alkalify the vagina, increase vaginal secretion and generate peculiar smell. The common symptoms of pruritus vulvae, burning sensation, swelling and pain, vaginal congestion, large leucorrhea amount, falling pain in the lower abdomen and the like caused by the above cause great inconvenience to normal life and work. Therefore, the key to preventing and treating vaginitis is to regulate the balance of vaginal flora in patients.
Clinically common vaginitis mainly comprises simple bacterial vaginitis, simple candida infection, trichomonas infection, mixed infection, atrophic/senile vaginitis and the like. The traditional treatment method of the vaginitis comprises oral or vaginal administration of metronidazole, clindamycin and other antibiotics for treatment, and chitosan medical appliance products with bacteriostatic efficacy are also appeared in recent years, although the antibacterial and bacteriostatic method can effectively treat the vaginitis. However, after treatment, pathogenic bacteria and beneficial bacteria in the vagina are killed at the same time, so that the vagina is not in a healthy and normal state, various bacteria can easily enter the vagina while being deficient, and if the pathogenic bacteria are in dominance again, vaginitis is relapsed. Researches show that the lactobacillus becomes a dominant flora by adjusting the proportion of the flora in the vagina, the pH value of the vagina is reduced, the cure rate of vaginitis can be effectively improved, the recurrence rate is reduced, and no obvious side effect exists. Meanwhile, the lower pH value is beneficial to the growth of the vaginal dominant flora and the restoration of the internal environment, and the maintenance of the acidic environment in the vagina can improve the treatment effect of the antibiotics. Therefore, the recovery and maintenance of the internal environment of the vagina are better ways to treat and prevent relapse. And for pregnant women, the application of antibiotics for treatment has contraindication, and even the administration by a vaginal route needs to be careful, so the safety of the vaginal environment regulating preparation applied to the pregnant women has obvious advantages.
The research shows that the single effect of inhibiting or killing vaginal pathogenic bacteria is obvious in recent period, but the environment in the vagina is not recovered to a normal state, so that the vaginitis is easy to relapse; and the simple supplement of probiotics or prebiotics can promote the probiotics to take the advantage of the position, but needs a long time and the symptom is slowly relieved. In addition, the first-line treatment medicine applied at present is mainly antibiotic, and has application safety risk for people with high vaginitis incidence like pregnant and lying-in women. There is therefore a need for a safe and effective vaginal pharmaceutical composition that can simultaneously meet these needs.
Disclosure of Invention
In order to solve the technical problems, the invention provides a vaginal pharmaceutical composition, a preparation and an application thereof. The pharmaceutical composition comprises collagen which has a protective effect on vaginal mucosa, natural flavonoid compounds of vaginal pathogenic microorganism inhibitors, prebiotics for promoting the growth of vaginal probiotics and schizophyllan for improving the immunity of organisms and maintaining the local anti-infection capability of vagina, and can be used for recovering the internal environment of the vagina, treating vaginitis caused by bacteria, fungi or viruses and preventing the occurrence and recurrence of vaginitis.
Specifically, the invention is realized by the following technical schemes:
in a first aspect, the present invention provides a pharmaceutical vaginal composition comprising collagen for protecting vaginal mucosa, natural flavonoids as inhibitors of pathogenic vaginal microorganisms, prebiotics for promoting the growth of vaginal probiotics and schizophyllan for enhancing immunity and maintaining local vaginal infection resistance.
Optionally, in the pharmaceutical composition for vaginal use, the pharmaceutical composition contains, by weight, 0.5% to 30% of collagen, 1.5% to 15% of natural flavonoids, 10% to 60% of prebiotics, and 1.5% to 15% of schizophyllan.
Optionally, in the pharmaceutical composition for vaginal use, the pharmaceutical composition contains, in weight percentage, 10% -30% of collagen, 10% -15% of natural flavonoids, 30% -60% of prebiotics and 10% -15% of schizophyllan.
Alternatively, in the vaginal pharmaceutical composition, the pharmaceutical composition comprises 20% collagen, 15% natural flavonoids, 50% prebiotics and 15% schizophyllan in weight percentage.
Alternatively, in the pharmaceutical composition for vaginal use described above, the collagen is a recombinant human type III collagen; the natural flavonoid compound is selected from one or more of the following: luteolin, baicalein, apigenin, quercetin, hesperidin or naringin; the prebiotics are selected from one or more of: lactose, sucrose, fructo-oligosaccharide, or malto-oligosaccharide; the schizophyllan is schizophyllan from fermentation of white ginseng.
Optionally, in the pharmaceutical composition for vaginal use, the collagen is recombinant human type III collagen, the natural flavonoid is naringin, the prebiotic is fructooligosaccharide, and the schizophyllan is schizophyllan derived from fermentation of white ginseng.
Alternatively, in the pharmaceutical composition for vaginal use, the pharmaceutical composition contains 20% of recombinant human type III collagen, 15% of naringin, 50% of fructo-oligosaccharide, and 15% of schizophyllan derived from fermentation of white ginseng bacteria, in percentage by weight.
In a second aspect, the present invention provides a pharmaceutical formulation for vaginal use, comprising the pharmaceutical composition of the first aspect above and a pharmaceutically acceptable excipient, wherein the pH of the pharmaceutical formulation is 4.5 or less.
Alternatively, in the above pharmaceutical preparation for vaginal use, the pharmaceutical preparation is a vaginal gel, a vaginal ointment, a vaginal foam, a vaginal suppository, a vaginal tablet, a vaginal hard capsule or a vaginal soft capsule, and the pH of the pharmaceutical preparation is 3 to 4.5.
Optionally, in the pharmaceutical preparation for vaginal use, the pharmaceutical preparation is a gel, the gel contains a gel matrix, a thickener, an emulsifier, a surfactant and a solvent, the gel matrix is selected from one or more of carbomer, xanthan gum, alginate, chitosan and hyaluronic acid, the thickener is selected from one or more of methyl cellulose, carboxymethyl cellulose, ethyl cellulose, hydroxyethyl cellulose, cyanoethyl cellulose, hydroxypropyl cellulose and hydroxypropyl methyl cellulose, the emulsifier is selected from one or more of polysorbate, polyglycerol ester, sodium stearoyl lactylate, calcium stearoyl lactylate and diacetyl tartaric acid monoglyceride, the surfactant is selected from one or more of lauryl glucoside, sodium lauryl sulfate, sodium dioctyl sodium sulfosuccinate dodecyl benzene sulfonate and sodium glycocholate, and the solvent is selected from one or more of glycerol, liquid paraffin and water, and the gel matrix is swelled by using lactic acid to adjust pH.
In a third aspect, the present invention provides the use of the pharmaceutical composition of the first aspect or the pharmaceutical formulation of the second aspect for the preparation of a medicament for restoring the internal environment of the vagina, repairing the vaginal mucosa, treating vaginitis, and preventing the occurrence and recurrence of vaginitis.
Alternatively, in the above use, the vaginitis is caused by bacteria, fungi or viruses.
Preferably, the vaginitis is caused by a vaginally pathogenic microorganism selected from the group consisting of: gardnerella vaginalis, candida albicans, atorvastatin, trichomonas vaginalis, neisseria gonorrhoeae, staphylococcus aureus, escherichia coli or human papilloma virus, said pharmaceutical composition or pharmaceutical formulation being capable of inhibiting or killing said vaginally pathogenic microorganism.
It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. For reasons of space, they are not described in detail herein.
Compared with the prior art, the invention has the following beneficial effects:
(1) The pharmaceutical composition comprises a plurality of active ingredients with different efficacies, which comprise collagen with the function of protecting vaginal mucosa, natural flavonoid compounds of vaginal pathogenic microorganism inhibitors, prebiotics for promoting the growth of vaginal probiotics and schizophyllan for improving the immunity of the organism and maintaining the local anti-infection capability of the vagina. Therefore, the vaginal pharmaceutical composition has higher inhibiting effect on bacteria, fungi and viruses, is helpful for repairing the normal internal environment of the vagina, and has the effects of moisturizing, protecting and improving vaginal mucosa, improving the immunity of patients and the like. The active ingredients in the vaginal medicinal composition have obvious synergistic interaction, and the combination of the active ingredients accords with the physiological characteristics of a female reproductive system.
(2) The vaginal pharmaceutical composition of the invention does not use antibiotics, so that the vaginal pharmaceutical composition has no drug resistance. In addition, various active ingredients in the pharmaceutical composition are safe and nontoxic, and the pharmaceutical composition is administrated in the vagina without systemic influence.
(3) The pharmaceutical composition for vagina has the advantages of wide source of various active ingredients, simple preparation method, mature industrial production method and low medication cost.
Detailed Description
In the intensive research on various active ingredients and pharmacological mechanisms thereof which can be used for preventing or treating vaginitis caused by various reasons, the inventor firstly discovers that the effect of preventing or treating vaginitis of the pharmaceutical composition for vagina can be obviously enhanced by combining collagen which has a protective effect on vaginal mucosa, natural flavonoid compounds of inhibitors of pathogenic microorganisms in vagina, prebiotics for promoting the growth of probiotics in vagina and schizophyllan for improving the immunity of the organism and maintaining the local anti-infection capability of vagina through a large amount of screening. The present invention has been completed based on this finding.
In the pharmaceutical composition, the natural vaginal pathogenic bacteria inhibiting components (such as natural flavonoids, schizophyllan and the like) and the substances for protecting and promoting the vaginal probiotics are used simultaneously, so that the symptoms can be rapidly eliminated in a short time, the normal internal environment of the vagina is promoted, and the vaginitis relapse is prevented. In addition, the vagina mucosa is irritated by pathogenic bacteria during inflammation to cause congestion and edema, and the vagina mucosa protective agent can form a protective film on the surface of the mucosa, so that the irritants and the mucosa are physically isolated, and the mucosa is sufficiently repaired.
As used herein, the "natural flavonoids" of the present invention can be obtained by extracting and separating the plant containing the active ingredient by a biological purification method, or can be purchased from commercially available products. The natural flavonoids may be selected from one or more of the following: luteolin, baicalein, apigenin, quercetin, hesperidin or naringin. The schizophyllan can be schizophyllan from fermentation of white ginseng, and can be purchased from commercial products.
The vaginal pharmaceutical preparation containing the vaginal pharmaceutical composition of the present invention may be vaginal gel, vaginal ointment, vaginal foam, vaginal suppository, vaginal tablet, vaginal hard capsule or vaginal soft capsule, and the pH of the pharmaceutical preparation is 3 to 4.5. The various dosage forms can be prepared according to the conventional process in the field of pharmaceutical preparation.
The pharmaceutical composition or pharmaceutical formulation of the invention is suitable for use in: treating various vaginal infectious diseases (such as bacterial vaginosis, candidal/mycotic vaginitis, trichomonas vaginitis, senile vaginitis, etc.) with antibiotics in combination and sequence; sequential treatment after regular treatment of the antibiotics for the vaginal infectious diseases helps to recover the normal internal environment of the vagina after the antibiotics kill pathogenic bacteria of the vagina, inhibits the pathogenic bacteria from becoming dominant flora again, supports the beneficial flora to obtain an occupying effect, and thus prevents the recurrence of vaginitis; can be used for recovering normal vaginal internal environment and preventing colpitis inflammation attack when vaginal flora disorder and internal environment disorder are caused by using systemic antibiotic in large amount; can be used for recovering normal vaginal internal environment and forming vaginal protective film to prevent vaginal inflammation attack when vaginal mucosa atrophy due to hormone level decrease during perimenopause, postmenopausal period or castration operation; can be used for treating pH increase caused by menstrual period and sexual life, and vaginal environment change caused by vaginal flora change, and can help to rapidly recover normal vaginal environment and prevent vaginal inflammation attack; after various intravaginal operations (such as digital vagina diagnosis, vaginal irrigation, transvaginal ultrasound, vaginal midwifery and the like), the vagina can be helped to quickly recover the normal internal environment of the vagina.
In the medical use of the vaginal pharmaceutical composition or vaginal pharmaceutical preparation of the present invention, the administration time, the number of times and the frequency of administration of the vaginal pharmaceutical composition or vaginal pharmaceutical preparation of the present invention and the like are determined according to the specific diagnosis result of the disease condition, and it is within the technical scope of those skilled in the art. For example, a therapeutic regimen for mice or rats is applied to humans, and the effective dose of all drugs to humans can be converted to the effective dose of the drug to mice or rats, which is also easily accomplished by one of ordinary skill in the art.
The invention is further illustrated with reference to specific examples. It should be understood that the specific embodiments described herein are illustrative only and are not limiting upon the scope of the invention.
The examples do not show the specific techniques or conditions, according to the technical or conditions described in the literature in the field, or according to the product specifications. The reagents or instruments used are conventional products which are not known to manufacturers and are available from normal sources.
The experimental procedures in the following examples are conventional unless otherwise specified. The test materials used in the following examples are all commercially available products unless otherwise specified.
Unless otherwise indicated, all percentages and parts referred to in the present invention are percentages and parts by weight.
Example (b):
preparation examples:
example 1:
a gel for vagina is prepared from the following components in percentage by weight: 2% of recombinant human source type III collagen, 1.5% of naringin, 5% of fructo-oligosaccharide, 1.5% of schizophyllan from fermentation of white ginseng bacteria and 90% of conventional gel matrix for blank vagina, wherein the pH value of the gel is 3-4.5.
Example 2:
a gel for vagina is prepared from the following components in percentage by weight: 3% of recombinant human source type III collagen, 1.5% of naringin, 4% of fructo-oligosaccharide, 1.5% of schizophyllan from white ginseng bacterium fermentation and 90% of conventional gel matrix for blank vagina, wherein the pH value of the gel is 3-4.5.
Example 3:
a gel for vagina is prepared from the following components in percentage by weight: 2% of recombinant human source type III collagen, 1% of naringin, 6% of fructo-oligosaccharide, 1% of schizophyllan from white ginseng bacterium fermentation and 90% of conventional gel matrix for blank vagina, wherein the pH value of the gel is 3-4.5.
Comparative example 1:
the vaginal gel is prepared from the following components in percentage by weight: 2% of recombinant human type III collagen, 5% of fructo-oligosaccharide and 93% of conventional gel matrix for blank vagina, wherein the pH value of the gel is 3-4.5.
Comparative example 2:
a gel for vagina is prepared from the following components in percentage by weight: 1.5 percent of naringin, 1.5 percent of schizophyllan from white ginseng fungus fermentation and 97 percent of conventional gel matrix for blank vagina, wherein the pH value of the gel is 3-4.5.
Comparative example 3:
a gel for vagina is prepared from the following components in percentage by weight: 2% of recombinant human source type III collagen, 1.5% of quercetin, 5% of fructo-oligosaccharide, 1.5% of schizophyllan from white ginseng bacterium fermentation and 90% of conventional gel matrix for blank vagina, wherein the pH value of the gel is 3-4.5.
Comparative example 4:
a gel for vagina is prepared from the following components in percentage by weight: 100% of a conventional gel matrix for a blank vagina, wherein the pH of the gel is 3-4.5.
Effect embodiment:
a first part: the effect of the pharmaceutical composition for preventing or treating vaginitis is investigated on an animal model of domestic rabbit vaginitis
1. Preparation of animal model of rabbit vaginitis
The experimental animals were purchased from Liaoning Biotechnology GmbH.
Preparation of bacterial vaginitis animal model
Before animal model making, the pH value of the vagina of the rabbit is detected to be 7.2 +/-0.1. Subculturing Staphylococcus aureus and Escherichia coli to obtain high-concentration pathogen suspension with concentration of 1 × 10 9 The suspension of the CFU/mL staphylococcus aureus and the escherichia coli is 0.2 mL, the suspension is injected into the vagina of a rabbit through a catheter, 1 time per day, after 3 days of continuous molding, the swelling and secretion condition of the vulva and the vagina of the animal are clinically checked, the vagina is taken and clinically tested by microorganism to determine whether the vagina contains infectious pathogenic bacteria, the vulva and the vagina generate obvious edema, and the vagina secretion is clinically tested by microorganism to contain the infectious pathogenic bacteria, so that the success of vaginitis preparation is judged.
Animal model of mycotic vaginitis
Culturing Candida albicans by subculture to obtain high-concentration bacteria suspension with concentration of 1 × 10 9 CFU/mL Candida albicans suspension 0.2 mL is injected into the vagina of a rabbit by a catheter, 1 time every day, and after continuous molding for 3 days, the swelling and secretion of the vulva and the vagina of the animal are clinically checked. The red swelling and secretion condition of the vulva and the vagina of the animal are clinically checked, and the vaginal and cervical secretions are taken to be tested by clinical microorganisms to determine whether the vaginal and cervical secretions contain pathogenic bacteria. The vagina secretion contains infectious pathogenic bacteria through clinical microbiological examination to judge the success of vaginitis.
Group administration and Observation
Vaginitis experiments 36 rabbits, 18 bacterial vaginosis and 18 mycotic vaginitis which are successfully modeled were randomly divided into example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group and model group, and each group contains 3 animals. In addition, 2 female rabbits without model are taken as a blank control group, the corresponding medicine is given to each rabbit once a day for 7 days continuously, the administration dose is controlled to fill the vagina and be smeared around the vulva, and sterile normal saline is given to the model group and the blank control group. The general behaviors and the vulva condition of animals are observed every day, the vulva and the vagina of the animals are clinically checked to be red and swollen and the secretion condition is generated after the last administration of 6 h, and the vagina and the cervix secretion are taken to be clinically tested whether to contain infectious pathogenic bacteria or not through microbes. The vulva and vagina red swelling is judged to be positive (+), and divided into light, medium and severe degrees according to the red swelling degree, which are respectively indicated by +++, ++, and plus, otherwise, judged to be (one), the secretion is judged to be positive (+) by clinical microbiological examination containing positive bacteria, divided into light, medium and severe degrees according to the quantity of the positive bacteria, which are respectively indicated by +++, ++, and plus, otherwise judged to be (one). The results of the experiments in each group are expressed as the mean value of the animals in each experiment.
Results of the experiment
For the rabbits with bacterial vaginitis and mycotic vaginitis, the experimental animals in the model group and the experimental animals in the comparative example 4 (blank gel matrix) have severe red swelling of the vaginal mucosa at the end of the research, and can detect a large amount of positive bacteria.
After treatment with the pharmaceutical composition of example 1 of the present invention, the redness of vaginal mucosa had been eliminated and both positive bacteria and mold turned negative in the experimental animals. The result shows that the active ingredients in the pharmaceutical composition have obvious synergistic interaction, and the pharmaceutical composition for vagina has stronger inhibition effect on bacteria and mould, and is also helpful for the normal internal environment of vagina and the repair of vaginal mucosa.
However, after the treatment using the pharmaceutical composition of comparative example 1, the redness and swelling of vaginal mucosa in the experimental animals was improved to some extent (+), but a larger amount of positive bacteria (++) and fungi (+++) could still be detected. This result indicates that the combination of pure recombinant human type III collagen and fructooligosaccharides may be insufficient in the treatment of vaginitis, in particular in the inhibition and killing of bacteria and fungi. In contrast, the redness and swelling of the vaginal mucosa of the experimental animals was hardly improved (+++), but the content of positive bacteria, bacteria (+) and fungi (+), in the vagina of the experimental animals was significantly reduced after the treatment with the pharmaceutical composition of comparative example 2. This result indicates that the combination of naringenin and schizophyllan, although having a strong bactericidal action, may be insufficient in helping the normal internal environment of the vagina and the repair of the vaginal mucosa.
Furthermore, interestingly, after replacing naringenin, which is the active ingredient in the pharmaceutical composition of the present invention, with quercetin, which is a more common flavonoid compound, it can be found that the pharmaceutical composition has reduced effects in both improving the vaginal redness and swelling condition and inhibiting or killing positive bacteria, and particularly has a more significant effect in inhibiting mold. The results show that the specific types of the active ingredients in the pharmaceutical composition of the invention may have certain influence on the effect of the pharmaceutical composition of the invention in preventing or treating vaginitis.
Table 1: the pharmaceutical composition of the invention has the function of preventing or treating the vaginitis of the rabbits
A second part: preliminary clinical trial results
60 patients with vaginitis were selected and divided into 2 groups, and according to the drugs in Table 2, example 1 and comparative example 1 were administered to the vagina of each group of patients, once every day, in the morning and evening, after 1 week of continuous administration, the vaginal samples of the patients were subjected to colony examination and the amounts of Human Papillomavirus (HPV), staphylococcus Aureus (SA), escherichia Coli (EC), pseudomonas Aeruginosa (PA), candida Albicans (CA), cluster A type B hemolytic streptococcus (GSA) samples were counted, and the microbial inhibition ratios were calculated according to the clinical routine method, and the results are shown in Table 2.
Table 2: the influence of the pharmaceutical composition on common microorganisms in vagina
The data in table 2 show that the pharmaceutical composition of the invention has significant inhibiting or killing effect on various common vaginal microorganisms, and the effect is significantly better than that of the combination of only recombinant human type III collagen and fructo-oligosaccharide.
In conclusion, the vaginal pharmaceutical composition has higher inhibition effect on bacteria, fungi and viruses, is helpful for repairing the normal internal environment of the vagina, and has the effects of moisturizing, protecting and improving vaginal mucosa, improving the immunity of patients and the like. The active ingredients in the vaginal medicinal composition have obvious synergistic interaction, and the combination of the active ingredients accords with the physiological characteristics of a female reproductive system. Therefore, the vaginal pharmaceutical composition provides more choices for clinically preventing or treating various types of vaginitis, and has higher economic value and social benefit.
It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (5)
1. A vaginal pharmaceutical composition characterized by: the pharmaceutical composition comprises collagen which has a protective effect on vaginal mucosa, natural flavonoid compounds of vaginal pathogenic microorganism inhibitors, prebiotics which promote the growth of vaginal probiotics and schizophyllan which is used for improving the immunity of the organism and maintaining the local anti-infection capability of the vagina, and comprises 20 percent of recombinant human type III collagen, 15 percent of naringin, 50 percent of fructo-oligosaccharide and 15 percent of schizophyllan which is derived from fermentation of white ginseng bacteria in percentage by weight.
2. A vaginal pharmaceutical formulation characterized by: the pharmaceutical formulation comprising the pharmaceutical composition of claim 1 and a pharmaceutically acceptable excipient, the pharmaceutical formulation being a vaginal gel, the pharmaceutical formulation having a pH of 3-4.5.
3. The pharmaceutical formulation of claim 2, wherein: the medicinal preparation is a gel, the gel contains a gel matrix, a thickening agent, an emulsifier, a surfactant and a solvent, the gel matrix is selected from one or more of carbomer, xanthan gum, alginate, chitosan and hyaluronic acid, the thickening agent is selected from one or more of methyl cellulose, carboxymethyl cellulose, ethyl cellulose, hydroxyethyl cellulose, cyanoethyl cellulose, hydroxypropyl cellulose and hydroxypropyl methyl cellulose, the emulsifier is selected from one or more of polysorbate, polyglycerol ester, sodium stearoyl lactylate, calcium stearoyl lactylate and diacetyl tartaric acid monoglyceride, the surfactant is selected from one or more of lauryl glucoside, sodium lauryl sulfate, sodium dioctyl sodium dodecyl benzene sulfonate and sodium glycocholate, and the solvent is selected from one or more of glycerol, liquid paraffin and water, and the gel matrix is swelled by adjusting pH with lactic acid.
4. Use of the pharmaceutical composition of claim 1 or the pharmaceutical formulation of claim 2 or claim 3 for the manufacture of a medicament for restoring the internal environment of the vagina, repairing the vaginal mucosa, treating vaginitis, which is vaginitis caused by bacteria, fungi or viruses, and preventing the occurrence and recurrence of vaginitis.
5. Use according to claim 4, characterized in that: the vaginitis is caused by a vaginally pathogenic microorganism selected from the group consisting of: gardnerella vaginalis, candida albicans, atorvastatin, trichomonas vaginalis, neisseria gonorrhoeae, staphylococcus aureus, escherichia coli or human papilloma virus, said pharmaceutical composition or pharmaceutical formulation being capable of inhibiting or killing said vaginally pathogenic microorganism.
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| CN117137938B (en) * | 2023-09-08 | 2024-04-05 | 广州小蛮腰医疗器械有限公司 | Pharmaceutical composition for repairing vaginal injury |
| CN117442778B (en) * | 2023-11-20 | 2024-05-10 | 美闺(长沙)医疗美容有限公司 | Gel composition for medical cosmetology |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101797304A (en) * | 2010-03-23 | 2010-08-11 | 杨霞 | Gel for adjusting microecology in vaginas of women |
| CN109010526A (en) * | 2018-08-23 | 2018-12-18 | 河北蕊雅生物科技有限公司 | One kind is for the antibacterial clean Traditional Chinese medicine gel composition of maintenance of vaginal mucosa |
| CN111759852A (en) * | 2020-08-04 | 2020-10-13 | 驯鹿(北京)管理咨询有限公司 | Pharmaceutical composition for vagina, pharmaceutical preparation, preparation method and application thereof |
| WO2021185728A1 (en) * | 2020-03-16 | 2021-09-23 | Biosearch, S.A. | Biocomposites comprising probiotics, collagen and bacterial extracellular polysaccharide and uses thereof |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101797304A (en) * | 2010-03-23 | 2010-08-11 | 杨霞 | Gel for adjusting microecology in vaginas of women |
| CN109010526A (en) * | 2018-08-23 | 2018-12-18 | 河北蕊雅生物科技有限公司 | One kind is for the antibacterial clean Traditional Chinese medicine gel composition of maintenance of vaginal mucosa |
| WO2021185728A1 (en) * | 2020-03-16 | 2021-09-23 | Biosearch, S.A. | Biocomposites comprising probiotics, collagen and bacterial extracellular polysaccharide and uses thereof |
| CN111759852A (en) * | 2020-08-04 | 2020-10-13 | 驯鹿(北京)管理咨询有限公司 | Pharmaceutical composition for vagina, pharmaceutical preparation, preparation method and application thereof |
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| 裂褶菌发酵产物主要活性成分的药理作用研究;刘伟峰;《中国优秀博硕士学位论文全文数据库(硕士)医药卫生科技辑》;20111015;E057-399 * |
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