A solid antibacterial gel and its preparation method and application

Abstract

The present invention provides a solid antibacterial gel and a preparation method and application thereof, wherein the solid antibacterial gel comprises an expansion carrier and an antibacterial gel coated on the surface of the expansion carrier; the raw materials of the antibacterial gel comprise a traditional Chinese medicine composition, a matrix, oligosaccharides and an acid-base source; the traditional Chinese medicine composition comprises an extract of Herba Corydalis, an extract of Acanthopanax senticosus and an extract of Ampelopsis pilosula. The present invention forms a protective gel film on the inner wall of the vagina to physically isolate the vaginal wall from external bacteria, thereby preventing the colonization of pathogenic microorganisms.

Description

Technical Field

[0001] The invention belongs to the technical field of vaginal suppositories, and in particular relates to a solid antibacterial gel and a preparation method and application thereof. Background Art

[0002] The female vaginal environment is very complex and is very easy to be infected by pathogenic bacteria and cause related diseases. There are often a variety of aerobic and anaerobic bacteria and other microorganisms in the female vagina, which are interdependent and mutually restricted, thus forming a relatively stable microecological environment. Studies have shown that when pathogenic bacteria invade the vaginal environment, the bacteria will multiply rapidly, destroying the acidic microenvironment in the vaginal environment, causing symptoms such as itching and fishy odor, and further may cause vaginal diseases such as bacterial vaginitis and yeast infection. At the same time, there is a certain possibility of causing urinary tract infection. With the deepening of research on reproductive tract infections, many scholars at home and abroad have recognized and reached a consensus that the occurrence of reproductive tract infections is related to vaginal flora imbalance, especially changes in beneficial vaginal bacteria. Therefore, restoring the vaginal flora environment of patients with reproductive tract infections and rebuilding the vaginal microecological environment are key ideas for treating such diseases.

[0003] CN100340263A discloses a suppository for treating bacterial vaginitis, which contains total alkaloids of Phellodendron amurense and volatile oil of Atractylodes macrocephala in a weight ratio of 1:1.6; the suppository has antibacterial, antifungal, anti-Trichomonas vaginalis, anti-inflammatory, analgesic and antipruritic effects, achieving the effect of treating both the symptoms and the root cause of bacterial vaginitis, and has a relatively obvious inhibitory and inactivating effect on common bacteria of vaginal infection such as Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Staphylococcus epidermidis, Proteus vulgaris, Streptococcus faecalis, Neisseria gonorrhoeae, and Gardnerella vaginalis.

[0004] CN1739538A discloses a suppository for treating mycotic vaginitis, wherein the suppository is prepared from metronidazole, nystatin and chlorhexidine acetate according to the following weights and units: metronidazole is 1800-2100 grams, nystatin is 130,000-180,000 units, and chlorhexidine acetate is 8-12 milligrams; metronidazole, nystatin and chlorhexidine acetate are put into a container according to the above weights and units, stirred evenly, and then put into a dispenser to prepare the suppository, and the weight of each suppository is 0.5 grams. The suppository directly acts on the lesion site, can promote the proliferation of vaginal epithelial cells, adjust the pH value, enhance the antibacterial ability, improve the permeability of the cell membrane, and is conducive to the absorption of local inflammation; and inhibits and kills deep and superficial fungi through mucosal absorption, thereby achieving a therapeutic effect.

[0005] CN109078069A discloses a vaginal mucosal antibacterial gel and a preparation method thereof, wherein the antibacterial gel contains a sophora japonica extract, a rose extract, carbomer, Tween 80, glycerol, poloxamer 188 and methylparaben. Preparation method: 1. Weigh the raw materials; 2. Mix glycerol, Tween 80 and purified water, and add poloxamer 188, sophora japonica extract and rose extract; 3. Weigh 0.3g of carbomer, add 20g of purified water until completely swollen, and obtain a swelling liquid; 4. Add the suspension to the swelling liquid, and then add methylparaben to obtain the obtained solution.

[0006] At present, there are many varieties and formulas of gynecological antibacterial gels on the market. Generally, they are Chinese herbal medicine extract antibacterial gels, including ginseng, sophora flavescens, Stephania macrophylla, Phellodendron amurense, aloe vera, etc. Western medicine antibacterial gels include guanidines, cationic antibacterial agents, chlorhexidine acetate, chlorhexidine gluconate, benzalkonium chloride, etc. When traditional antibacterial gels are injected into the vagina and encounter salt and electrolytes in the human body, they tend to become thin immediately and cannot adhere well to the vaginal epithelial cells, resulting in them naturally flowing out before they can stay in the inner wall of the vagina to play an antibacterial role, resulting in low efficacy and poor therapeutic effect of gynecological gels. There are various microorganisms in nature, and some microorganisms entering the body will have a greater impact on the human body's internal environment and even cause various infectious diseases; therefore, how to overcome the above-mentioned technical problems and defects has become a key issue that needs to be solved.

[0007] Therefore, developing a broad-spectrum therapeutic drug that can improve the vaginal flora environment from the root, has good therapeutic effects and low recurrence rate is a research focus in this field. Summary of the invention

[0008] In view of the deficiencies in the prior art, the object of the present invention is to provide a solid antibacterial gel and a preparation method and application thereof, which can fundamentally improve the vaginal flora environment, have good therapeutic effects and low recurrence rate.

[0009] In order to achieve the purpose of the invention, the present invention adopts the following technical solutions:

[0010] In a first aspect, the present invention provides a solid antibacterial gel, the solid antibacterial gel comprising an expansion carrier and an antibacterial gel coated on the surface of the expansion carrier;

[0011] The raw materials of the antibacterial gel include a Chinese medicine composition, a matrix, oligosaccharides and an acid-base source;

[0012] The traditional Chinese medicine composition comprises herba schizonepetae extract, acanthopanax senticosus extract and ampelopsis pilosula extract.

[0013] The present invention forms a protective gel film on the inner wall of the vagina to physically isolate the vaginal wall from external bacteria, thereby preventing the colonization of pathogenic microorganisms. The built-in expansion carrier effectively increases the contact area between the active ingredient and the vagina, increases the duration of the drug effect, improves the protective ability, and adsorbs and removes secretions in the vagina. The use of an acid-base source can present an effervescent effect, increase the contact area between the drug and the vagina, allow the drug to penetrate deep into the folds of the vaginal mucosa, give full play to the drug effect, and at the same time adjust the vaginal pH value, improve cleanliness, and improve the vaginal microecological environment.

[0014] The taste of gujingcao is pungent, sweet, and neutral. It has the effects of dispersing wind, improving eyesight, and removing cataracts. Studies have shown that it has inhibitory effects on Staphylococcus aureus, dysentery, Salmonella typhi, and Escherichia coli, and has inhibitory effects on fungi such as Odusan and Microsporum rust. Therefore, gujingcao has bactericidal and antibacterial effects. The main active ingredients in Acanthopanax senticosus are flavonoids, saponins, and polysaccharides. It is a typical tonic drug with significant strengthening and calming effects, and has outstanding biological activity on the circulation and cardiovascular and cerebrovascular systems. The herb contains chrysophanol, chrysophanol, rhamnol, fumaric acid, gallic acid and other antibacterial and fungal ingredients, and has the effects of clearing away heat and detoxifying, eliminating carbuncle and dispersing knots, astringing sores and promoting tissue regeneration, and studies have shown that it has different degrees of inhibitory effects on skin fungi such as Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Trichophyton concentricum, Microsporum audouinum, inguinale and Epidermophyton rubrum. The present invention adds the ingredients of the Chinese medicine composition to the solid antibacterial gel, effectively improves the antibacterial effect of the antibacterial gel and effectively reduces the recurrence of inflammation, and it is found through testing that the Herba Corydalis extract, Acanthopanax senticosus extract and the herb are matched, and the three synergistically exert excellent antibacterial and bactericidal effects.

[0015] Preferably, the expansion carrier is a tampon.

[0016] Preferably, after the expansion carrier absorbs water, the maximum water absorption of each particle is ≥1.5 mL, for example, it can be 1.6 mL, 1.65 mL, 1.7 mL, 1.75 mL, 1.8 mL, etc.

[0017] Preferably, the mass ratio of the expansion carrier to the antibacterial gel is 1:(1-2), for example, 1:1.3, 1:1.5, 1:1.8, etc.

[0018] Preferably, the antibacterial gel is semi-enclosed and coated on 1 / 5-4 / 5 of the front end of the expansion carrier, for example, it can be 1 / 5, 2 / 5, 3 / 5, 4 / 5.

[0019] Preferably, the mass percentage of the acid-base source in the antibacterial gel is 0.003-0.0075%, for example, it can be 0.004%, 0.005%, 0.006%, 0.007%, etc.

[0020] Preferably, the acid and alkali sources include citric acid and sodium bicarbonate.

[0021] Preferably, the mass ratio of the acid source to the alkali source in the acid-base source is (1-10):1, for example, it can be 2:1, 4:1, 6:1, 8:1, etc.

[0022] Preferably, the matrix comprises gelatin glycerol, polyethylene glycol and carbomer homopolymers.

[0023] Preferably, the mass ratio of gelatin to glycerol in the gelatin glycerol is 1:(30-40), for example, it can be 1:32, 1:34, 1:36, 1:38, etc.

[0024] Preferably, the polyethylene glycol comprises polyethylene glycol 4000 and / or polyethylene glycol 400.

[0025] Preferably, the mass ratio of polyethylene glycol 4000 to polyethylene glycol 400 is (7-9):1, for example, it can be 7.5:1, 8:1, 8.5:1, etc.

[0026] Preferably, the mass percentage of the traditional Chinese medicine composition in the antibacterial gel is 3-6%, for example, 3.5%, 4%, 4.5%, 5%, 5.5%, etc.

[0027] Preferably, the mass ratio of the Herba Corydalis extract, the Acanthopanax senticosus extract and the Bletilla striata extract in the traditional Chinese medicine composition is 1:(1-2):(2-3), for example, it can be 1:1:2, 1:1:3, 1:2:2, 1:2:3, etc.

[0028] Other specific point values ​​within the above numerical ranges can be selected and will not be described in detail here.

[0029] Preferably, the Herba Corydalis extract is prepared by the following method, which comprises: extracting the Herba Corydalis with water, filtering and concentrating under reduced pressure to obtain the Herba Corydalis extract.

[0030] Preferably, the solid-liquid ratio of the water extraction is 1:(15-25), for example, it can be 1:16, 1:18, 1:20, 1:22, 1:24, etc.

[0031] Preferably, the water extraction temperature is 95-100°C, for example, 96°C, 97°C, 98°C, 99°C, etc.; the time is 1.5-2.5h, for example, 1.6h, 1.8h, 2h, 2.2h, 2.4h, etc.

[0032] Preferably, the reduced pressure concentration is to one tenth of the original water volume.

[0033] Preferably, the Acanthopanax senticosus extract is prepared by the following method, comprising: extracting Acanthopanax senticosus with water, filtering, concentrating under reduced pressure, and precipitating with alcohol to obtain Acanthopanax senticosus extract, diluting the Acanthopanax senticosus extract, adsorbing and eluting, collecting the eluate, and concentrating under reduced pressure to obtain the Acanthopanax senticosus extract.

[0034] Preferably, the solid-liquid ratio of the water extraction is 1:(15-25), for example, it can be 1:16, 1:18, 1:20, 1:22, 1:24, etc.

[0035] Preferably, the extraction time is 1.5-2.5 h, for example, it can be 1.6 h, 1.8 h, 2 h, 2.2 h, 2.4 h, etc.

[0036] Preferably, the adsorption elution is performed using a macroporous resin.

[0037] Preferably, the eluent for the adsorption elution is a 50-70% ethanol solution (for example, 55%, 60%, 65%, etc.), and the amount of the eluent is 1.5-2.5BV, for example, 1.6BV, 1.8BV, 2BV, 2.2BV, 2.4BV, etc.

[0038] Preferably, the Bletilla striata extract is prepared by the following method, which comprises: extracting Bletilla striata with water, filtering and concentrating under reduced pressure to obtain a water extract, and separating the water extract by high-speed countercurrent chromatography to obtain the Bletilla striata extract.

[0039] Preferably, the solid-liquid ratio of the water extraction is 1:(80-120), for example, it can be 1:90, 1:100, 1:110, etc.

[0040] Preferably, the concentration of soluble solids in the water extract is 0.08-0.12 g / mL, for example, 0.09 g / mL, 0.1 g / mL, 0.11 g / mL, etc.

[0041] Preferably, during the high-speed countercurrent chromatography separation, n-butanol is first used for elution, and then a methanol-water solution is used for elution.

[0042] Other specific point values ​​within the above numerical ranges can be selected and will not be described in detail here.

[0043] In a second aspect, the present invention provides a method for preparing the solid antibacterial gel as described in the first aspect, the preparation method comprising:

[0044] (1) After the matrix components are mixed and melted, oligosaccharides are added and homogenized to obtain a melt;

[0045] (2) adding the Chinese medicine composition to the melt, and adding an acid or alkali source to adjust the pH value to 4-6, and then homogenizing to obtain a bacteriostatic gel;

[0046] (3) placing the antibacterial gel in a plug mold, inserting an expansion carrier, cooling and shaping, and obtaining the solid antibacterial gel.

[0047] In a third aspect, the present invention provides a use of the solid antibacterial gel as described in the first aspect in the preparation of a drug for treating vulvar and vaginal infections and vulvar itching caused by bacteria.

[0048] Compared with the prior art, the present invention has the following beneficial effects:

[0049] The present invention forms a protective gel film on the inner wall of the vagina to physically isolate the vaginal wall from external bacteria, thereby preventing the colonization of pathogenic microorganisms. The built-in expansion carrier effectively increases the contact area between the active ingredient and the vagina, improves the duration of the drug effect, improves the protection ability, and adsorbs and removes the secretions in the vagina. The use of an acid-base source can present an effervescent effect, increase the contact area between the drug and the vagina, allow the drug to penetrate deep into the folds of the vaginal mucosa, give full play to the drug effect, and adjust the vaginal pH value, improve cleanliness, and improve the vaginal microecological environment. The addition of the ingredients of the Chinese medicine composition effectively improves the antibacterial effect of the antibacterial gel and effectively reduces the recurrence of inflammation. In addition, the present invention combines the Herba Corydalis extract, the Herba Acanthopanacis Senticosi extract and the Herba Ampelopsise extract, and the three synergistically exert excellent antibacterial and bactericidal effects. DETAILED DESCRIPTION

[0050] The technical solution of the present invention is further described below by specific implementation methods. It should be understood by those skilled in the art that the embodiments are only to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0051] As used herein, the terms "comprises," "including," "having," "containing," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus that comprises the listed elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.

[0052] "Optional" or "any one" means that the subsequently described matter or event can or cannot occur, and that the description includes instances where the event occurs and instances where it does not.

[0053] The indefinite articles "a" and "an" before the elements or components of the present invention have no limitation on the quantity requirements (i.e. the number of occurrences) of the elements or components. Therefore, "a" or "an" should be interpreted as including one or at least one, and the elements or components in the singular form also include the plural form, unless the quantity obviously refers to the singular form only.

[0054] The terms "one embodiment", "some embodiments", "exemplarily", "specific examples" or "some examples" described in the present invention mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this document, the schematic representation of the above terms does not necessarily refer to the same embodiment or example.

[0055] The sources of reagents or instruments in the following examples are as follows:

[0056] Carbomer homopolymer: purchased from Guangzhou Kangqiao Hamp Pharmaceutical Co., Ltd.

[0057] Preparation Example 1

[0058] This preparation example provides a Herba Codonopsis pilosulae extract, and the preparation method is as follows:

[0059] Take the Herba Corydalis and chop it into pieces, add it to 20 times the amount of distilled water, heat it to 100°C, continue extracting for 2 hours, filter it through 50 mesh, and concentrate the filtrate at 60°C to one tenth of the original water volume to obtain the Herba Corydalis extract.

[0060] Preparation Example 2

[0061] This preparation example provides an Acanthopanax senticosus extract, and the preparation method is as follows:

[0062] Take Acanthopanax senticosus and 20 times of water, crush the Acanthopanax senticosus and add it to water, perform ultrasonic extraction for 2 hours, filter to remove residue, concentrate the filtrate under reduced pressure to one tenth of the original water volume, add 5 times of ethanol for alcohol precipitation, and recover the ethanol to obtain Acanthopanax senticosus extract; dilute the Acanthopanax senticosus extract with 35 times of water, use macroporous resin for adsorption, use 60% ethanol solution for elution, the eluent is used in an amount of 2BV, recover the eluent, and concentrate under reduced pressure to one twentieth of the original water volume to obtain the Acanthopanax senticosus extract.

[0063] Preparation Example 3

[0064] This preparation example provides a Bletilla striata extract, and the preparation method is as follows:

[0065] Mix the white ampel and 100 times the amount of water, perform water extraction at 100°C for 1.5 hours, filter while hot and concentrate under reduced pressure to obtain a water extract with a soluble solid concentration of 0.1 g / mL, separate the water extract by high-speed countercurrent chromatography, first elute with 20 times the amount of n-butanol, then elute with 10 times the amount of 50% methanol aqueous solution, collect the eluate, and concentrate under reduced pressure to remove the solvent to obtain the white ampel extract.

[0066] Preparation Example 4

[0067] This preparation example provides a gelatin glycerol, and the preparation method is as follows:

[0068] Take gelatin, glycerin and water in the ratio of 1:35:15. First, add gelatin into purified water and soak it for 10 hours; slowly add glycerin and homogenize, then heat to 80°C until the water in the mixture evaporates to obtain gelatin glycerin.

[0069] Example 1

[0070] This embodiment provides a solid antibacterial gel, the raw material composition is as follows:

[0071]

[0072] (1) After the matrix components are fully melted and mixed, oligosaccharides are added and homogenized to obtain a melt;

[0073] (2) adding the Chinese medicine composition to the melt, and adding an acid or alkali source to adjust the pH value to 5, and then homogenizing to obtain a bacteriostatic gel;

[0074] (3) The antibacterial gel is placed in a plug mold, an expansion carrier is inserted, and the plug is cooled and shaped to obtain 1000 pieces of the solid antibacterial gel.

[0075] Example 2

[0076] This embodiment provides a solid antibacterial gel, the raw material composition is as follows:

[0077]

[0078] The preparation method is the same as that in Example 1, and 1000 pieces of the solid antibacterial gel are obtained.

[0079] Example 3

[0080] This embodiment provides a solid antibacterial gel, the raw material composition is as follows:

[0081]

[0082] The preparation method is the same as that in Example 1, and 1000 pieces of the solid antibacterial gel are obtained.

[0083] Example 4

[0084] This embodiment provides a solid antibacterial gel, the raw material composition is as follows:

[0085] The only difference between the above-mentioned embodiment 1 is that the Herba Corydalis extract is adjusted to 35 g, the Herba Acanthopanacis Senticosus extract is adjusted to 15 g, and the Herba Bletillae Sinensis extract is adjusted to 30 g. The other raw materials, dosages and preparation methods are the same as those in the above-mentioned embodiment 1.

[0086] Example 5

[0087] This embodiment provides a solid antibacterial gel, the raw material composition is as follows:

[0088] The only difference between the above-mentioned embodiment 1 is that the Herba Corydalis extract is adjusted to 15 g, the Herba Acanthopanacis Senticosus extract is adjusted to 35 g, and the Herba Bletillae Sinensis extract is adjusted to 30 g. The other raw materials, dosages and preparation methods are the same as those in the above-mentioned embodiment 1.

[0089] Example 6

[0090] This embodiment provides a solid antibacterial gel, the raw material composition is as follows:

[0091] The only difference between the above-mentioned embodiment 1 is that the Herba Corydalis extract is adjusted to 15 g, the Herba Acanthopanacis Senticosus extract is adjusted to 15 g, and the Herba Ampelopsis Smilax extract is adjusted to 50 g. The other raw materials, dosages and preparation methods are the same as those in the above-mentioned embodiment 1.

[0092] Example 7

[0093] This embodiment provides a solid antibacterial gel, the raw material composition is as follows:

[0094] The difference between the above-mentioned example and the first embodiment is that the polyethylene glycol 4000 is adjusted to 530 g and the polyethylene glycol 400 is adjusted to 40 g. The other raw materials, dosages and preparation methods are the same as those in the first embodiment.

[0095] Example 8

[0096] This embodiment provides a solid antibacterial gel, the raw material composition is as follows:

[0097] The difference between the above-mentioned example and the first embodiment is that the polyethylene glycol 4000 is adjusted to 490 g and the polyethylene glycol 400 is adjusted to 80 g. The other raw materials, dosages and preparation methods are the same as those in the first embodiment.

[0098] Comparative Example 1

[0099] This comparative example provides a solid antibacterial gel, the raw material composition is as follows:

[0100] The difference between the above method and Example 1 is that the Herba Corydalis extract is adjusted to 40 g, the Acanthopanax senticosus extract is adjusted to 40 g, and the Ampelopsis pilosula extract is not added. The other raw materials, dosages and preparation methods are the same as those in Example 1.

[0101] Comparative Example 2

[0102] This comparative example provides a solid antibacterial gel, the raw material composition is as follows:

[0103] The difference between the above method and Example 1 is that the Herba Corydalis extract is adjusted to 26.5 g, the Herba Ampelopsise extract is adjusted to 53.5 g, and the Acanthopanax senticosus extract is not added. The other raw materials, dosages and preparation methods are the same as those in Example 1.

[0104] Comparative Example 3

[0105] This comparative example provides a solid antibacterial gel, the raw material composition is as follows:

[0106] The difference between the above method and Example 1 is that the amount of Acanthopanax senticosus extract is 26.5 g, the amount of Ampelopsis pilosula extract is 53.5 g, and no Herba Corydalis extract is added. The other raw materials, dosages and preparation methods are the same as those in Example 1.

[0107] Test Example 1

[0108] Expansion value test

[0109] The diameter of the rear end sliver of the solid antibacterial gel provided in the embodiment of the present invention and the comparative example was measured with a vernier caliper, and the diameters were measured again after rolling 90°. The average value R of the diameters of the two tests was taken; after the above-mentioned vaginal expansion plug was used for the determination of the melting time limit, the remaining slivers were immediately taken out, and after the water dripped, they were gently placed on a glass plate, and the diameters of the two ends and three parts in the middle of each sliver were measured with a vernier caliper. The diameters of the three parts were measured again after rolling about 90°. A total of six diameter data were obtained for each sliver, and the average value r was taken; the expansion value P = r / R; 3 samples of each vaginal expansion plug were tested in parallel, and the average value was taken. The radial expansion value data obtained are shown in Table 1.

[0110] Test Example 2

[0111] Stability test

[0112] The solid antibacterial gel provided in the embodiment of the present invention and the comparative example was placed in a constant temperature and humidity chamber at 30°C and 65% humidity for 36 months, and samples were taken for testing at 0 month (i.e. before placement), 3 months, 6 months, 9 months, 12 months, 24 months, and 36 months, respectively. The properties and melting time of the solid antibacterial gel were detected according to the provisions of the Chinese Pharmacopoeia. It was determined that the solid antibacterial gel was light yellow, smooth, and crack-free at 0 month, and the melting time was 25 minutes. The test results for 36 months are shown in Table 1.

[0113] Table 1

[0114]

[0115]

[0116] According to the data in the table, the radial expansion values ​​of the solid antibacterial gel provided in the embodiments and comparative examples of the present invention are greater than 1.5, which can meet the administration requirements of the expandable suppository. After the solid antibacterial gel is placed in a constant temperature and humidity environment for 36 months, its color, appearance and other properties and melting time do not change significantly. It can be seen from Examples 1 and 7-8 that when the polyethylene glycol in the matrix is ​​polyethylene glycol 4000 and polyethylene glycol 400, the state and melting time of the solid antibacterial gel are more stable when the proportion of the present invention is adopted.

[0117] Test Example 3

[0118] Antibacterial performance test

[0119] According to the method of the 2017 edition of the "Technical Specifications for Disinfection" of the Ministry of Health, the sustained-release microemulsion thermosensitive antibacterial gel prepared by the solid antibacterial gel prepared in the examples and comparative examples of the present invention was tested for the bactericidal effect of microorganisms. The test item was the bactericidal rate, and the test bacteria included Staphylococcus aureus ATCC6538, Candida albicans ATCC10231, Trichomonas vaginalis, Neisseria gonorrhoeae and Escherichia coli 0157.

[0120] Test method: 40 mL of the solid antibacterial gel prepared in the embodiment and the comparative example were measured and divided into 4 portions, each 10 mL, and acted on Staphylococcus aureus for 3 minutes, Candida albicans for 8 minutes, Trichomonas vaginalis and Neisseria gonorrhoeae for 10 minutes, and Escherichia coli for 1 hour. The test results are shown in Table 2.

[0121] Table 2

[0122]

[0123]

[0124] According to the data in the table, the solid antibacterial gel provided by the present invention has a good bactericidal effect on Staphylococcus aureus, Candida albicans, Trichomonas vaginalis, Neisseria gonorrhoeae and Escherichia coli, wherein the bactericidal rate of the preferred embodiments 1-3 for Staphylococcus aureus, Candida albicans, Trichomonas vaginalis, Neisseria gonorrhoeae and Escherichia coli reaches more than 98.5%. The Herba Corydalis extract, Acanthopanax senticosus extract and Ampelopsis pilosula extract in the traditional Chinese medicine composition act synergistically to jointly exert the bactericidal and antibacterial effects, and the three traditional Chinese medicine extracts have a more excellent bactericidal and antibacterial effect when they meet the ratio relationship adopted by the present invention.

[0125] The applicant declares that the present invention illustrates the process of the present invention through the above-mentioned embodiments, but the present invention is not limited to the above-mentioned embodiments, that is, it does not mean that the present invention must rely on the above-mentioned embodiments to be implemented. Those skilled in the art should understand that any improvement of the present invention, equivalent replacement of various raw materials of the product of the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

Claims

1. A solid antibacterial gel, It is characterized in that The solid antibacterial gel comprises an expansion carrier and an antibacterial gel coated on the surface of the expansion carrier; The raw materials of the antibacterial gel are composed of a Chinese medicine composition, a matrix, oligosaccharides and an acid-base source; The mass percentage of the Chinese medicine composition in the antibacterial gel is 3-6%; The traditional Chinese medicine composition is composed of Herba Codonopsis pilosulae extract, Acanthopanax senticosus extract and Ampelopsis pilosulae extract; The mass ratio of the Herba Corydalis extract, the Herba Acanthopanacis senticosus extract and the Herba Bletillae Sinensis extract in the traditional Chinese medicine composition is 1:(1-2):(2-3); The Herba Corydalis extract is prepared by the following method, which comprises: extracting the Herba Corydalis with water, filtering and concentrating under reduced pressure to obtain the Herba Corydalis extract; The Acanthopanax senticosus extract is prepared by the following method, which comprises: extracting Acanthopanax senticosus with water, filtering, concentrating under reduced pressure, and precipitating with alcohol to obtain Acanthopanax senticosus extract, diluting the Acanthopanax senticosus extract, adsorbing and eluting, collecting the eluate, and concentrating under reduced pressure to obtain the Acanthopanax senticosus extract; The ampelopsis radiata extract is prepared by the following method, which comprises: extracting the ampelopsis radiata with water, filtering and concentrating under reduced pressure to obtain a water extract, and separating the water extract by high-speed countercurrent chromatography to obtain the ampelopsis radiata extract.

2. The solid antibacterial gel according to claim 1, It is characterized in that The expansion carrier is a tampon.

3. The solid antibacterial gel according to claim 1, It is characterized in that The mass ratio of the expansion carrier to the antibacterial gel is 1:(1-2).

4. The solid antibacterial gel according to claim 1, It is characterized in that The mass percentage of the acid-base source in the antibacterial gel is 0.003-0.0075%.

5. The solid antibacterial gel according to claim 1, It is characterized in that The acid and alkali sources include citric acid and sodium bicarbonate.

6. The solid antibacterial gel according to claim 1, It is characterized in that The matrix includes gelatin glycerin, polyethylene glycol and carbomer homopolymers.

7. The solid antibacterial gel according to claim 6, It is characterized in that The mass ratio of gelatin to glycerol in the gelatin glycerol is 1:(30-40).

8. The solid antibacterial gel according to claim 6, It is characterized in that The polyethylene glycol includes polyethylene glycol 4000 and / or polyethylene glycol 400.

9. The solid antibacterial gel according to claim 6, It is characterized in that The mass ratio of polyethylene glycol 4000 to polyethylene glycol 400 is (7-9):

1.

10. The solid antibacterial gel according to claim 1, It is characterized in that The solid-liquid ratio of the Herba Corydalis water extraction is 1:(15-25).

11. The solid antibacterial gel according to claim 1, It is characterized in that The temperature of the Herba Codonopsis pilosulae water extraction is 95-100° C. and the time is 1.5-2.5 hours.

12. The solid antibacterial gel according to claim 1, It is characterized in that The Herba Corydalis is concentrated under reduced pressure to one tenth of the original water volume.

13. The solid antibacterial gel according to claim 1, It is characterized in that The solid-liquid ratio of the Acanthopanax senticosus water extraction is 1:(15-25).

14. The solid antibacterial gel according to claim 1, It is characterized in that The extraction time of Acanthopanax senticosus is 1.5-2.5h.

15. The solid antibacterial gel according to claim 1, It is characterized in that The adsorption elution is carried out using a macroporous resin.

16. The solid antibacterial gel according to claim 1, It is characterized in that The eluent for the adsorption elution is a 50-70% ethanol solution, and the amount of the eluent used is 1.5-2.5 BV.

17. The solid antibacterial gel according to claim 1, It is characterized in that The solid-liquid ratio of the water extraction of the white ampelopsis is 1:(80-120).

18. The solid antibacterial gel according to claim 1, It is characterized in that The concentration of soluble solids in the water extract of Bletilla striata is 0.08-0.12 g / mL.

19. The solid antibacterial gel according to claim 1, It is characterized in that During the high-speed countercurrent chromatography separation, n-butanol is first used for elution, and then a methanol aqueous solution is used for elution.

20. A method for preparing the solid antibacterial gel according to any one of claims 1 to 19, It is characterized in that The preparation method comprises: (1) After the matrix components are mixed and melted, oligosaccharides are added and homogenized to obtain a melt; (2) adding the Chinese medicine composition to the melt, and adding an acid or alkali source to adjust the pH value to 4-6, and then homogenizing to obtain a bacteriostatic gel; (3) placing the antibacterial gel in a plug mold, inserting an expansion carrier, cooling and shaping, and obtaining the solid antibacterial gel.

21. Use of the solid antibacterial gel according to any one of claims 1 to 19 in the preparation of a drug for treating vulvar and vaginal infections and vulvar pruritus caused by bacteria.

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