Andrographolide gel as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of female private part nursing, and particularly relates to andrographolide gel as well as a preparation method and application thereof. The invention provides an andrographolide gel, which is prepared from the following components in parts by mass: 0.1 to 0.5 part of andrographolide, 2.0 parts of caprylic / capric polyethylene glycol glyceride, 5.0 parts of propylene glycol, 0.05 to 0.2 part of chitosan, 10.0 parts of 1 percent W / V lactic acid solution, 0.15 to 0.6 part of hydroxyethyl cellulose and 30.0 parts of water. The andrographolide, the caprylic / capric polyethylene glycol glyceride, the propylene glycol, the chitosan, the 1% W / V lactic acid solution, the hydroxyethyl cellulose and the water are combined for use, the proportion of the components is strictly limited, and the obtained andrographolide gel can effectively inhibit vaginal pathogenic bacteria (including candida chromosomes, escherichia coli, staphylococcus aureus and gardnerella); the traditional Chinese medicine is used for treating fungal vaginitis and has no irritation to vaginal tissues.

Description

Technical Field

[0001] The invention belongs to the technical field of female private parts care, and in particular relates to andrographolide gel and a preparation method and application thereof. Background Art

[0002] Vulvovaginal candidiasis, also known as vulvovaginal candidiasis (VVC), is mainly caused by Candida (candida) infection, among which Candida albicans is the most common pathogen. VVC has a high incidence rate in women, about 70% to 75% of women have experienced at least one infection in their lifetime; the recurrence rate is also quite significant, 40% to 50% of infected people will get sick again; 5% to 10% of women will be diagnosed with recurrent vaginal candidiasis, that is, at least four attacks in a year, which is difficult to cure and is currently the most difficult type of vaginal infection to treat clinically.

[0003] Currently, the treatment of VVC is mainly based on antibacterial drugs. Five major types of antifungal drugs are commonly used in the treatment of Candida albicans infections, including azoles, acrylamides, echinocandins, polyenes, and nucleoside analogs. However, the fungal clearance rate and clinical effect of traditional antifungal drugs are limited. Summary of the invention

[0004] The purpose of the present invention is to make up for the deficiencies of the prior art and provide an andrographolide gel and a preparation method and application thereof, which can effectively inhibit vaginal pathogens including Candida albicans, Escherichia coli, Staphylococcus aureus and Gardnerella, treat fungal vaginitis, and have no irritation to vaginal tissue.

[0005] The present invention provides an andrographolide gel, which comprises the following components in parts by mass:

[0006] 0.1-0.5 parts of andrographolide, 2.0 parts of caprylic acid and capric acid macrogol esters, 5.0 parts of propylene glycol, 0.05-0.2 parts of chitosan, 10.0 parts of 1% W / V lactic acid solution, 0.15-0.6 parts of hydroxyethyl cellulose and 30.0 parts of water.

[0007] Preferably, the following components are included in parts by mass:

[0008] 0.1-0.5 parts of andrographolide, 2.0 parts of caprylic acid and capric acid macrogol ester, 5.0 parts of propylene glycol, 0.1 parts of chitosan, 10.0 parts of 1% W / V lactic acid solution, 0.6 parts of hydroxyethyl cellulose and 30.0 parts of water.

[0009] The present invention also provides a method for preparing the andrographolide gel described in the above technical solution, comprising the following steps:

[0010] andrographolide, caprylic acid capric acid macrogol glyceride and propylene glycol are mixed at 37° C. to obtain an andrographolide solution;

[0011] mixing chitosan and 1% W / V lactic acid solution at 37° C. to obtain a chitosan solution;

[0012] Hydroxyethyl cellulose and water were mixed at 37°C to obtain HEC gel;

[0013] The andrographolide solution, the chitosan solution and the HEC gel are mixed to obtain the andrographolide gel.

[0014] Preferably, the method of mixing the andrographolide solution, the chitosan solution and the HEC gel comprises: mixing the chitosan solution and the andrographolide solution, adding the HEC gel and stirring.

[0015] Preferably, the stirring time is 20 to 40 minutes.

[0016] The present invention also provides the use of the andrographolide gel described in the above technical solution or the andrographolide gel obtained by the preparation method described in the above technical solution in the preparation of antibacterial products.

[0017] Preferably, the antibacterial product is a product that inhibits pathogenic bacteria, and the pathogenic bacteria include one or more of Candida albicans, Escherichia coli, Staphylococcus aureus and Gardnerella vaginalis.

[0018] The present invention also provides the use of the andrographolide gel described in the above technical solution or the andrographolide gel obtained by the preparation method described in the above technical solution in the preparation of products for treating fungal vaginitis.

[0019] Preferably, the fungal vaginitis includes candidal vaginitis.

[0020] Preferably, the fungal vaginitis is fungal vaginitis caused by Candida albicans.

[0021] Beneficial effects:

[0022] The invention provides an andrographolide gel, which comprises the following components by weight: 0.1-0.5 parts of andrographolide, 2.0 parts of caprylic acid capric acid polyethylene glycol glyceride, 5.0 parts of propylene glycol, 0.05-0.2 parts of chitosan, 10.0 parts of 1% W / V lactic acid solution, 0.15-0.6 parts of hydroxyethyl cellulose and 30.0 parts of water. The invention uses andrographolide, caprylic acid capric acid polyethylene glycol glyceride, propylene glycol, chitosan, 1% W / V lactic acid solution, hydroxyethyl cellulose and water in combination, and strictly limits the proportion of the components. The obtained andrographolide gel can effectively inhibit vaginal pathogens (including Candida albicans, Escherichia coli, Staphylococcus aureus and Gardnerella), treat fungal vaginitis, and has no irritation to vaginal tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required to be used in the embodiments are briefly introduced below.

[0024] Figure 1 This is a macroscopic characterization diagram of andrographolide vaginal gel in Example 7;

[0025] Figure 2 The inhibition rates of different concentrations of andrographolide vaginal gel on vaginal pathogens; compared with the blank group, different lowercase letters represent significant differences;

[0026] Figure 3 The numbers of live Candida albicans in the vagina of rats with VVC vaginitis before and after administration of different concentrations of andrographolide vaginal gel; different lowercase letters represent significant differences compared with the blank group before administration. DETAILED DESCRIPTION

[0027] The present invention provides an andrographolide gel, which comprises the following components in parts by mass:

[0028] 0.1-0.5 parts of andrographolide, 2.0 parts of caprylic acid and capric acid macrogol esters, 5.0 parts of propylene glycol, 0.05-0.2 parts of chitosan, 10.0 parts of 1% W / V lactic acid solution, 0.15-0.6 parts of hydroxyethyl cellulose and 30.0 parts of water.

[0029] According to the mass percentage, the andrographolide gel of the present invention comprises 0.1 to 0.5 parts of andrographolide. As an embodiment, the andrographolide gel of the present invention comprises 0.25 parts of andrographolide. The andrographolide of the present invention is purchased from Solebol, with a CAS number of 5508-58-7.

[0030] Based on the mass fraction of andrographolide, the andrographolide gel of the present invention includes 1.0 to 5.0 parts of caprylic acid capric acid polyethylene glycol glyceride. As an embodiment, the andrographolide gel of the present invention includes 2.0 to 4.0 parts of caprylic acid capric acid polyethylene glycol glyceride; as another embodiment, the andrographolide gel of the present invention includes 2.0 parts of caprylic acid capric acid polyethylene glycol glyceride. The present invention utilizes caprylic acid capric acid polyethylene glycol glyceride, which is used as a surfactant to enhance the water solubility of andrographolide and promote the dissolution of andrographolide.

[0031] Based on the mass fraction of andrographolide, the andrographolide gel of the present invention includes 1.0 to 5.0 parts of propylene glycol. As another embodiment, the andrographolide gel of the present invention includes 2.0 to 5.0 parts of propylene glycol; as another embodiment, the andrographolide gel of the present invention includes 4.0 to 5.0 parts of propylene glycol; as another embodiment, the andrographolide gel of the present invention includes 5.0 parts of propylene glycol. The present invention utilizes propylene glycol, which has strong hydrophilicity, can enhance the water solubility of andrographolide, and promote the dissolution of andrographolide.

[0032] Based on the mass fraction of andrographolide, the andrographolide gel of the present invention includes 0.05-0.2 parts of chitosan. As an embodiment, the andrographolide gel of the present invention includes 0.1 parts of chitosan. The present invention uses chitosan as one of the andrographolide gel forming matrices.

[0033] Based on the mass fraction of andrographolide, the andrographolide gel of the present invention includes 5.0 to 15.0 parts of 1% W / V lactic acid solution. As an embodiment, the andrographolide gel of the present invention includes 8.0 to 12.0 parts of 1% W / V lactic acid solution; as another embodiment, the andrographolide gel of the present invention includes 10.0 parts of 1% W / V lactic acid solution. The present invention utilizes lactic acid solution to adjust pH.

[0034] Based on the mass fraction of the andrographolide, the andrographolide gel of the present invention includes 0.15 to 0.6 parts of hydroxyethyl cellulose. As an embodiment, the andrographolide gel of the present invention includes 0.2 to 0.5 parts of hydroxyethyl cellulose; as another embodiment, the andrographolide gel of the present invention includes 0.3 parts of hydroxyethyl cellulose. The present invention uses hydroxyethyl cellulose as the main molding matrix of the andrographolide gel.

[0035] Based on the mass fraction of the andrographolide, the andrographolide gel of the present invention includes 15 to 45 parts of water. As an embodiment, the andrographolide gel of the present invention includes 20 to 45 parts of water; as another embodiment, the andrographolide gel of the present invention includes 25 to 45 parts of water; as another embodiment, the andrographolide gel of the present invention includes 30.0 parts of water. As an embodiment, the water of the present invention is purified water.

[0036] The invention uses andrographolide, caprylic acid capric acid macrogol glyceride, propylene glycol, chitosan, 1% W / V lactic acid solution, hydroxyethyl cellulose and water in combination to obtain andrographolide gel which can effectively inhibit vaginal pathogens, treat fungal vaginitis and has no irritation to vaginal tissue.

[0037] The present invention also provides a method for preparing the andrographolide gel described in the above technical solution, comprising the following steps:

[0038] andrographolide, caprylic acid capric acid macrogol glyceride and propylene glycol are mixed at 37° C. to obtain an andrographolide solution;

[0039] mixing chitosan and 1% W / V lactic acid solution at 37° C. to obtain a chitosan solution;

[0040] Hydroxyethyl cellulose and water were mixed at 37°C to obtain HEC gel;

[0041] The andrographolide solution, the chitosan solution and the HEC gel are mixed to obtain the andrographolide gel.

[0042] The present invention mixes andrographolide, caprylic acid capric acid macrogol glyceride and propylene glycol at 25 to 37° C. to obtain an andrographolide solution. As an embodiment, the present invention mixes andrographolide, caprylic acid capric acid macrogol glyceride and propylene glycol at 37° C. The present invention has no strict requirements on the mixing method, and a conventional method in the art, such as stirring, can be used.

[0043] The present invention mixes chitosan and 1% W / V lactic acid solution at 25-37° C. to obtain a chitosan solution. As an embodiment, the present invention mixes chitosan and 1% W / V lactic acid solution at 37° C. The present invention has no strict requirements on the mixing method, and the chitosan and 1% W / V lactic acid solution can be completely dissolved by conventional methods in the art, such as stirring.

[0044] The present invention mixes hydroxyethyl cellulose and water at 25-37° C. to obtain HEC gel. As an embodiment, the present invention mixes hydroxyethyl cellulose and water at 37° C. The present invention has no strict requirements on the mixing method, and the hydroxyethyl cellulose and water can be completely dissolved by conventional methods in the art, such as stirring.

[0045] After obtaining the andrographolide solution, chitosan solution and HEC gel, the present invention mixes the andrographolide solution, chitosan solution and HEC gel to obtain andrographolide gel. As an embodiment, the present invention sequentially adds chitosan solution and andrographolide solution to HEC gel and stirs. As an embodiment, the stirring time of the present invention is 20 to 40 minutes; as an embodiment, the stirring time of the present invention is 30 minutes. The present invention limits the addition of HEC gel after the chitosan solution and andrographolide solution are mixed to ensure that chitosan, andrographolide and HEC gel are fully mixed and cross-linked.

[0046] The present invention also provides the use of the andrographolide gel described in the above technical solution or the andrographolide gel obtained by the preparation method described in the above technical solution in the preparation of antibacterial products.

[0047] As an embodiment, the antibacterial product of the present invention is a product for inhibiting pathogens, and the pathogens include one or more of Candida albicans, Escherichia coli, Staphylococcus aureus and Gardnerella; as another embodiment, the pathogens of the present invention include Candida albicans, Escherichia coli, Staphylococcus aureus and Gardnerella.

[0048] The present invention also provides the use of the andrographolide gel described in the above technical solution or the andrographolide gel obtained by the preparation method described in the above technical solution in the preparation of products for treating fungal vaginitis.

[0049] As an embodiment, the fungal vaginitis described in the present invention includes candidal vaginitis. As an embodiment, the fungal vaginitis described in the present invention is fungal vaginitis caused by Candida albicans.

[0050] In order to further illustrate the present invention, an andrographolide gel provided by the present invention and its preparation method and application are described in detail below in conjunction with the accompanying drawings and examples, but they should not be construed as limiting the scope of protection of the present invention.

[0051] Example 1

[0052] A method for preparing andrographolide vaginal gel, comprising the following specific steps:

[0053] 1. Prepare materials: 0.1 g of andrographolide, 2.0 g of caprylic acid and capric acid macrogol ester, 5.0 g of propylene glycol, 0.05 g of chitosan, 10.0 g of 1% W / V lactic acid solution, 0.15 g of hydroxyethyl cellulose and 30.0 g of purified water.

[0054] 2. Stir andrographolide, caprylic acid capric acid macrogol glyceride and propylene glycol at 37° C. to obtain andrographolide solution.

[0055] 3. Add chitosan to 1% W / V lactic acid solution and stir at 37°C until completely dissolved to obtain a chitosan solution.

[0056] 4. Add hydroxyethyl cellulose to purified water and stir at 37°C until completely dissolved to obtain HEC gel.

[0057] 5. Add the chitosan solution obtained in step 3 and the andrographolide solution obtained in step 2 to the HEC gel obtained in step 4 in sequence, continue stirring for 20 to 40 minutes to mix well, and obtain andrographolide vaginal gel.

[0058] Example 2

[0059] A method for preparing andrographolide vaginal gel similar to Example 1, except that the mass of andrographolide is 0.25 g.

[0060] Example 3

[0061] A method for preparing andrographolide vaginal gel similar to Example 1, except that the mass of andrographolide is 0.5 g.

[0062] Example 4

[0063] A method for preparing andrographolide vaginal gel is similar to Example 1, except that the mass of andrographolide is 0.25 g, and the mass of chitosan is 0.1 g.

[0064] Example 5

[0065] A method for preparing andrographolide vaginal gel is similar to Example 1, except that the mass of andrographolide is 0.25 g, and the mass of chitosan is 0.2 g.

[0066] Example 6

[0067] A method for preparing andrographolide vaginal gel is similar to Example 1, except that the mass of andrographolide is 0.25 g, the mass of chitosan is 0.1 g, and the mass of hydroxyethyl cellulose is 0.3 g.

[0068] Example 7

[0069] A method for preparing andrographolide vaginal gel is similar to Example 1, except that the mass of andrographolide is 0.25 g, the mass of chitosan is 0.1 g, and the mass of hydroxyethyl cellulose is 0.6 g.

[0070] Comparative Example 1

[0071] A method for preparing a vaginal gel, compared with Example 1, does not use andrographolide, and the specific steps are as follows:

[0072] 1. Prepare materials: 4.0 g of caprylic acid and capric acid polyethylene glycol ester, 3.0 g of propylene glycol, 0.05 g of chitosan, 10.0 g of 1% W / V lactic acid solution, 0.15 g of hydroxyethyl cellulose and 30.0 g of purified water.

[0073] 2. Stir caprylic / capric macrogol glyceride and propylene glycol at 37°C to obtain a premix.

[0074] 3. Add chitosan to 1% W / V lactic acid solution and stir at 37°C until completely dissolved to obtain a chitosan solution.

[0075] 4. Add hydroxyethyl cellulose to purified water and stir at 37°C until completely dissolved to obtain HEC gel.

[0076] 5. Add the chitosan solution obtained in step 3 and the premixed solution obtained in step 2 to the HEC gel obtained in step 4 in sequence, continue stirring for 20 to 40 minutes to mix well, and obtain a vaginal gel.

[0077] Comparative Example 2

[0078] A method for preparing a vaginal gel, compared with Example 1, does not use chitosan, and the specific steps are as follows:

[0079] 1. Prepare materials: 0.25 g of andrographolide, 2.0 g of caprylic acid and capric acid macrogol ester, 5.0 g of propylene glycol, 10.0 g of 1% W / V lactic acid solution, 0.3 g of hydroxyethyl cellulose and 30.0 g of purified water.

[0080] 2. Stir andrographolide, caprylic acid capric acid macrogol glyceride and propylene glycol at 37° C. to obtain andrographolide solution.

[0081] 3. Add hydroxyethyl cellulose to purified water and stir at 37°C until completely dissolved to obtain HEC gel.

[0082] 4. Add 1% W / V lactic acid solution and the andrographolide solution obtained in step 2 to the HEC gel obtained in step 3 in sequence, continue stirring for 20 to 40 minutes to obtain andrographolide vaginal gel.

[0083] Comparative Example 3

[0084] A method for preparing a vaginal gel, compared with Example 1, does not use hydroxyethyl cellulose, and the specific steps are as follows:

[0085] 1. Prepare materials: 0.25 g of andrographolide, 2.0 g of caprylic acid and capric acid macrogol ester, 5.0 g of propylene glycol, 0.1 g of chitosan, 10.0 g of 1% W / V lactic acid solution and 30.0 g of purified water.

[0086] 2. Stir andrographolide, caprylic acid capric acid macrogol glyceride and propylene glycol at 37° C. to obtain andrographolide solution.

[0087] 3. Add chitosan to 1% W / V lactic acid solution and stir at 37°C until completely dissolved to obtain a chitosan solution.

[0088] 4. Add the chitosan solution obtained in step 3 and the andrographolide solution obtained in step 2 into purified water in sequence, continue stirring for 20 to 40 minutes to mix well, and obtain andrographolide vaginal gel.

[0089] Test Example 1

[0090] The pH values ​​of the vaginal gels obtained in Examples 1 to 7 and Comparative Examples 1 to 3 were measured using a pH meter, and their fluidity, viscosity and formability were evaluated according to the standards in Table 1. The results are shown in Table 2.

[0091] Table 1 Evaluation criteria for gel sensory indexes

[0092]

[0093] Table 2 Basic properties of different vaginal gels

[0094]

[0095]

[0096] According to Table 2, the vaginal gel obtained in Example 7 has the best formability and viscosity, moderate fluidity and is easier to stay in the vagina, and a pH value of 3.79, which is equivalent to the pH of the normal vaginal environment. The actual picture is as shown in Figure 1 shown.

[0097] Example 8

[0098] A method for preparing andrographolide vaginal gel similar to Example 7, except that the mass of andrographolide is 0.1 g.

[0099] Example 9

[0100] A method for preparing andrographolide vaginal gel similar to Example 7, except that the mass of andrographolide is 0.5 g.

[0101] Test Example 2

[0102] Antibacterial effect detection

[0103] The andrographolide vaginal gel obtained in Examples 7 to 9 was used as the vaginal gel to be tested. The antibacterial effects of different vaginal gels to be tested on vaginal pathogens (Candida albicans, Escherichia coli, Staphylococcus aureus and Gardnerella) were evaluated by co-culture method. The lower the bacterial survival rate, the higher the antibacterial rate. The specific steps are as follows:

[0104] In the experimental group, 0.5 g of the vaginal gel to be tested was added to a 2 mL sterile EP tube, followed by 1 mL of 10 5 CFU / mL vaginal pathogen suspension. After incubation at 37℃ for 12h, dilute 100μL of the incubated bacterial suspension 10-100 times. Add 100μL of the diluent to the agar plate and incubate at 37℃ for 12-24h. Count the colony forming units. Take the bacterial suspension without andrographolide vaginal gel as the blank group, and calculate the bacterial survival rate according to the following formula: Survival rate (%) = CFU 实验组 / CFU 空白组 × 100%, the results are shown in Table 3 and Figure 2 shown.

[0105] Table 3 Bacterial survival rate of different tested vaginal gels

[0106] Vaginal gel to be tested Candida albicans Escherichia coli Staphylococcus aureus Gardnerella Blank Group 99.3±1.7％ 99.0±1.4％ 99.7±1.7％ 100.3±3.4％ Example 8 (0.1) 52.3±1.7％ 39.0±1.4％ 34.0±1.6％ 41.7±1.2％ Example 7 (0.25) 8.7±0.9％ 5.8±0.5％ 6.5±1.2％ 6.3±0.8％ Example 9 (0.5) 7.1±1.3％ 4.0±0.8％ 6.3±0.5％ 5.7±0.9％

[0107] According to Table 3 and Figure 2 It can be seen that the andrographolide vaginal gel obtained in Examples 7 to 9 can effectively reduce the amount of viable vaginal pathogens. A good inhibitory effect has been achieved when the andrographolide concentration is 0.1 g / tube (2.1 mg / g). When the andrographolide concentration is 0.25 g / tube (5.2 mg / g), more than 90% of vaginal pathogens can be inhibited. The antibacterial effect does not change much when the andrographolide concentration continues to increase.

[0108] Test Example 3

[0109] Vaginal irritation test

[0110] Twelve female SD rats weighing 200-250 g were selected and randomly divided into four treatment groups: blank group, 0.1AG group, 0.25AG group and 0.5AG group, with 3 rats in each group, and the following treatments were performed:

[0111] Blank group: rats were given 200 μL of normal saline intravaginally;

[0112] 0.1AG group: rats were intravaginally administered 200 μL of andrographolide vaginal gel obtained in Example 8;

[0113] 0.25AG group: rats were intravaginally administered 200 μL of andrographolide vaginal gel obtained in Example 7;

[0114] 0.5AG group: 200 μL of andrographolide vaginal gel obtained in Example 9 was administered intravaginally to rats.

[0115] 24 hours after administration, the vagina and surrounding tissues and vaginal mucosa of rats in each treatment group were observed with the naked eye for congestion, edema, changes in secretions, etc., and the vaginal mucosal irritation reaction was scored according to the standards in Table 4. The scoring results are shown in Table 5.

[0116] Table 4 Evaluation criteria for vaginal mucosal irritation response

[0117] Points Evaluation Criteria Vaginal mucosa / 0 No change or slight change 1 The blood vessels on the mucosal surface are slightly congested and red 2 Redness and swelling of the mucosal surface 3 Erosion and congestion of mucosal surface Secretions / 0 No color change or becomes transparent 1 The color is slightly white, and the amount has increased 2 White in color, thick, large in quantity 3 Yellowish or greenish in color, thick, large in volume, and smelly

[0118] Table 5 Vaginal mucosal irritation response scoring results

[0119] Treatment Group Points Blank Group 0 0.1AG group 0 0.25AG group 0 0.5AG group 0

[0120] According to the naked eye observation and the scoring results in Table 5, it can be seen that the vaginal mucosa of the rats in each treatment group did not show redness or swelling, and no large amount of secretions were produced, indicating that the andrographolide vaginal gel has no irritation to the vaginal tissue of rats.

[0121] Test Example 4

[0122] Testing the therapeutic effect of candidal vaginitis (VVC vaginitis)

[0123] 1. Select 200-250g female SD rats and establish a rat candidal vaginitis model by intravaginal infusion of Candida albicans solution. Specifically: before infusion of Candida albicans solution, subcutaneous injection of estradiol benzoate was performed for 3 consecutive days at a dose of 1.2 mg / kg, once a day, to induce pseudoestrus and immunosuppressive environment. Then, a micropipette was used to inoculate the rat vagina with a physiological saline suspension of Candida albicans (50 μL / rat, bacterial concentration 1.0×10 8 CFU / mL), once a day for 5 consecutive days. After injection, a sterile cotton ball was used to block the vaginal opening for 5 to 10 minutes to prevent the liquid from flowing out. After 5 consecutive days of inoculation, a large number of cells, fungal spores and hyphae were observed under a microscope, indicating that the modeling was successful.

[0124] 2. The rats with successful modeling were randomly divided into four treatment groups: blank group, 0.1AG group, 0.25AG group and 0.5AG group, with 3 rats in each group, and the following treatments were performed:

[0125] Blank group: rats were given 200 μL of normal saline intravaginally;

[0126] 0.1AG group: rats were intravaginally administered 200 μL of andrographolide vaginal gel obtained in Example 8;

[0127] 0.25AG group: rats were intravaginally administered 200 μL of andrographolide vaginal gel obtained in Example 7;

[0128] 0.5AG group: 200 μL of andrographolide vaginal gel obtained in Example 9 was administered intravaginally to rats.

[0129] Each treatment group was given the drug once a day for 5 consecutive days. After 24 hours of the last administration, a sterile cotton swab was used to rotate the rat vagina once to collect secretions, which were then placed in 1 mL of normal saline. 100 μL was spread on the SDA agar plate, and the average number of colonies in each group was calculated after 48 hours. The results are shown in the figure. Figure 3 and as shown in Table 6.

[0130] Table 6 The number of viable Candida albicans bacteria before and after medication in each treatment group (CFU / mL)

[0131] Treatment Group Before administration After administration Blank Group <![CDATA[5.50×10 3 ]]> <![CDATA[5.90×10 3 ]]> 0.1AG group <![CDATA[5.07×10 3 ]]> <![CDATA[2.71×10 2 ]]> 0.25AG group <![CDATA[5.47×10 3 ]]> 9.67 0.5AG group <![CDATA[5.53×10 3 ]]> 8.25

[0132] According to Table 6 and Figure 3 It can be seen that after 5 days of medication, the number of live Candida albicans in the 0.1AG group, 0.25AG group and 0.5AG group decreased compared with the control group. When the andrographolide concentration in the andrographolide vaginal gel reached 0.25g / tube (5.2mg / g), it could effectively eliminate the Candida in the vagina of VVC rats and achieve significant therapeutic effects.

[0133] It can be seen from the above content that the andrographolide gel provided by the present invention can effectively inhibit Candida albicans, Escherichia coli, Staphylococcus aureus and Gardnerella, treat fungal vaginitis, and has no irritation to vaginal tissue.

[0134] Although the above embodiment describes the present invention in detail, it is only a part of the embodiments of the present invention, not all of the embodiments. People can also obtain other embodiments based on this embodiment without creativity, and these embodiments all fall within the protection scope of the present invention.

Claims

1. An andrographolide gel, characterized in that: According to the mass percentage, it includes the following components: 0.1-0.5 parts of andrographolide, 2.0 parts of caprylic acid and capric acid macrogol esters, 5.0 parts of propylene glycol, 0.05-0.2 parts of chitosan, 10.0 parts of 1% W / V lactic acid solution, 0.15-0.6 parts of hydroxyethyl cellulose and 30.0 parts of water.

2. The andrographolide gel according to claim 1, characterized in that According to the mass percentage, it includes the following components: 0.1-0.5 parts of andrographolide, 2.0 parts of caprylic acid and capric acid macrogol ester, 5.0 parts of propylene glycol, 0.1 parts of chitosan, 10.0 parts of 1% W / V lactic acid solution, 0.6 parts of hydroxyethyl cellulose and 30.0 parts of water.

3. The method for preparing the andrographolide gel according to claim 1 or 2, characterized in that: The steps include: andrographolide, caprylic acid capric acid macrogol glyceride and propylene glycol are mixed at 37° C. to obtain an andrographolide solution; Mixing chitosan and 1% W / V lactic acid solution at 37° C. to obtain a chitosan solution; Hydroxyethyl cellulose and water were mixed at 37°C to obtain HEC gel; The andrographolide solution, the chitosan solution and the HEC gel are mixed to obtain the andrographolide gel.

4. The preparation method according to claim 3, characterized in that: The method of mixing the andrographolide solution, the chitosan solution and the HEC gel comprises: mixing the chitosan solution and the andrographolide solution, adding the HEC gel and stirring.

5. The preparation method according to claim 4, characterized in that: The stirring time is 20 to 40 minutes.

6. Use of the andrographolide gel according to claim 1 or 2 or the andrographolide gel obtained by the preparation method according to any one of claims 3 to 5 in the preparation of antibacterial products.

7. The use according to claim 6, characterized in that: The antibacterial product is a product for inhibiting pathogenic bacteria, and the pathogenic bacteria include one or more of Candida albicans, Escherichia coli, Staphylococcus aureus and Gardnerella vaginalis.

8. Use of the andrographolide gel according to claim 1 or 2 or the andrographolide gel obtained by the preparation method according to any one of claims 3 to 5 in the preparation of products for treating fungal vaginitis.

9. The use according to claim 8, characterized in that: The fungal vaginitis includes candidal vaginitis.

10. The use according to claim 8 or 9, characterized in that: The fungal vaginitis is fungal vaginitis caused by Candida albicans.

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