CN113975228B - Gynecological antibacterial gel and application thereof - Google Patents
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Abstract
The invention relates to the technical field of gynecological medical use, in particular to a gynecological antibacterial gel for treating colpitis. A gynecological antibacterial gel comprises matrine, repairing agent, gel matrix and adhesive with repairing function, wherein the adhesive with repairing function is mussel mucin. The gynecological antibacterial gel can effectively improve the killing rate of fungi, and particularly reduce the recurrence rate of colpitis.
Description
Technical Field
The invention relates to the technical field of gynecological medical use, in particular to a gynecological antibacterial gel for treating colpitis.
Background
Vaginitis is an inflammatory disease caused by inflammatory changes of the vaginal mucosa, and submucosal connective tissue, caused by pathogenic microorganisms. Colpitis mycotica is a common type of vaginitis, which is common in clinic, and the pathogenic bacteria of colpitis albicans are mainly candida albicans. According to clinical statistics, the incidence rate of colpitis mycotica is as high as 75%. If the control is not performed in time, inflammation can attack the internal reproductive organs, induce pelvic inflammation and the like, and seriously influence the physical and mental health of patients.
Clinically, the broad-spectrum antifungal medicament is a common medicament for clinically treating colpitis mycotica, and can remove infectious pathogenic bacteria and improve clinical symptoms. According to the report of the literature, the oral antifungal medicine and the traditional Chinese medicine compound lotion are used for washing vagina or the traditional Chinese medicine extracts such as matrine, zedoary turmeric oil and the like are used for preparing vaginal suppositories for treatment, and satisfactory curative effects can be obtained.
However, compared with candida simplex vaginitis, the intractable candida vaginitis is characterized by difficult radical treatment and high recurrence rate, and the recurrence rate reaches 5 percent in literature. The patient can diagnose recurrent mycotic vaginitis, also called refractory candidal vaginitis, by checking vaginal secretion candidal for 4 times or more within 1 year.
The high recurrence rate of colpitis mycotica is mainly caused by the broken bacterial balance, abnormal proliferation of pathogenic bacteria and the like caused by the change of physical and chemical conditions of the environment in the vagina. The long-term use of the traditional Chinese medicine lotion and the preparation is easy to cause the change of the internal environment of vagina, and the repeated use of a large amount of antibiotics is an important cause of candida drug resistance and repeated inflammation. The existing treatment method for purely killing candida albicans can promote the occurrence of recurrence while achieving the curative effect.
How to prevent the recurrence of colpitis mycotica is a difficult problem in the treatment of gynecological colpitis, but the current clinically used drugs and treatment methods cannot effectively solve the problem.
Matrine is mainly extracted from Sophora alopecuroide of Leguminosae, is white or light yellow, has good antibacterial and antiinflammatory effects, and can promote granulation and astringe. The matrine vaginal preparation is mainly used for treating colpitis mycotica. If the literature reports that matrine gel treats 322 cases of colpitis mycotica, the clinical cure rate is 37.89%, the obvious efficiency is 32.61%, the total effective rate is 96.89%, and the matrine gel has better curative effect on treating simple colpitis mycotica.
Madecassic acid, also known as asiaticoside, is a pale yellow to yellowish brown powder; has no odor, bitter taste, slightly hygroscopicity, is a weak acidic compound with larger molecular weight, and has pharmacological effects of inhibiting fibroblast proliferation, resisting tumor, resisting inflammation, protecting cardiovascular system, etc. Madecassic acid has the effects of accelerating wound healing by activating epithelial tissues, inhibiting collagen synthesis and controlling excessive proliferation of matrix and fiber components of connective tissues to treat scars, so that the madecassic acid can be widely applied clinically to inhibit fibroblast proliferation to treat fibrotic diseases such as burn scars and scleroderma, but has no related application and research to prove that the madecassic acid has a therapeutic effect or an auxiliary effect on colpitis mycotica.
The vaginitis is generated by the external genitalia of women, has complex structure and more folds of skin and mucous membrane, not only has sweat glands and sebaceous glands, but also has secretions of the large vestibule glands, cervix and vagina, and menstrual discharge, so that the general external preparation is difficult to be attached to the affected part for a long time to act; in addition, some fungi are easily hidden in the wrinkled or inflamed skin, and it is difficult for the existing external preparation to completely kill the fungi, so that the mycotic vaginitis repeatedly recurs.
Disclosure of Invention
The invention aims to provide an antibacterial gel for treating colpitis mycotica, which has good curative effect and low recurrence rate.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
a gynecological antibacterial gel comprises matrine, repairing agent, gel matrix and adhesive with repairing function, wherein the adhesive with repairing function is mussel mucin.
Further, the repair agent is madecassic acid and the mussel mucin is mussel mucin mfp-3 or mussel mucin mfp-5.
Further, the antibacterial gel comprises the following components: contains 4% matrine ethanol solution 2-5%, madecassic acid 0.5-2%, mussel mucin 0.1-0.3%, carbomer 0.3-1%, purified water,
further, the pH of the gynecological antibacterial gel is 4.1-4.5.
Further, the beverage also comprises other auxiliary materials, wherein the other auxiliary materials are essence and PH regulator. The gel matrix is carbomer or sodium alginate.
Further, matrine is 4% matrine ethanol solution, and the mass ratio of matrine, madecassic acid and mussel mucin is 3:1:0.2.
further, the antibacterial gel is prepared from the following components: 3.0% of 4% matrine ethanol solution, 1.0% of madecassic acid, 0.2% of mussel mucin mfp-5, 0.6% of carbomer, 0.02% of other auxiliary materials and the balance of purified water.
Application of gynecological antibacterial gel in preparing medicine for treating recurrent mycotic vaginitis is provided.
Application of gynecological antibacterial gel in auxiliary medicine after ovarian cancer operation is provided.
According to the gynecological antibacterial gel, the matrine ethanol solution, the madecassic acid and the mussel mucin mfp-5 are adopted in a specific mass ratio, so that pathogenic fungi of colpitis can be effectively killed, the synergistic effect of the matrine ethanol solution, the madecassic acid and the mussel mucin mfp-5 is utilized, the action time of the gel on an affected part is prolonged by utilizing the strong adhesion and the repair effect of the mussel mucin mfp-5, continuous sterilization and repair of inflammatory skin are carried out, the killing rate of fungi can be effectively improved, and particularly the recurrence rate of colpitis is reduced.
Detailed Description
Examples
Preparing antibacterial gel:
the main components are as follows:
matrine: hunan Kaelarui Biotech Co., ltd;
madecassic acid: nanjing spring and autumn bioengineering Co., ltd;
asiaticoside: nanjing spring and autumn bioengineering Co., ltd;
mussel mucin, mussel mucin Mfp-5: university of ocean in Zhejiang.
The inventive samples and control samples were prepared and formulated as shown in table 1 below:
table 1:
the other auxiliary materials of the sample 1 are essence and PH regulator, and the consumption is 0.01 percent respectively.
Sample 1 preparation method:
(1) Preparing 4% matrine ethanol solution: weighing matrine extract, adding 95% ethanol according to calculated amount, and dissolving to obtain ethanol solution containing 4% matrine.
(2) Weighing madecassic acid, adding into purified water, and heating for dissolving; adding 4% matrine ethanol solution with the prescription amount, and stirring uniformly; adding mussel mucin mfp-5, and stirring uniformly; and weighing carbomer 940, uniformly dispersing in the liquid level, keeping the liquid level calm, adding essence after the carbomer 940 is completely swelled, uniformly stirring, and adding a PH regulator to enable the PH value of the gel to reach 4.3.
In vitro antibacterial test
1. Test sample: samples 1 to 7 obtained in example 1, and commercially available clotrimazole plugs;
culture medium: glucose agar, glucose liquid culture medium.
And (3) strain: candida albicans is separated from leucorrhea and cervical secretion specimens of clinical colpitis patients, and is identified by a bud tube formation test, a thick film sporulation test and a mice pathogenicity test.
2. Experimental method
20ml of thawed and cooled glucose agar (Saccharum sinensis Roxb.) at 45deg.C is poured into a sterilization plate with an inner diameter of 9cm by bacteria collection mixing and dosing method, and solidified. A plurality of culture plates were prepared in this way, three loops of diluted bacteria solution with a concentration of 104CFU/ml were picked up with a standard inoculating loop, inoculated by densely streaking on the plates, sterilized oxford cups with an inner diameter of 6mm were used, and 6 tubes were placed equidistantly on the surface of the culture medium. The compound liquid medicine is respectively sucked into 50ul holes by a microsampler, placed in a 37 ℃ incubator for culturing for 48 hours, the diameter value of a bacteriostasis circle is measured, the experiment is repeated for 3 times, and the average value of 3 times is taken as the bacteriostasis diameter, and the bacteriostasis diameter is shown in table 2.
3. Experimental results
Table 2: experimental results of inhibition zone
Test for resisting rabbit vaginal mucosa artificial fungus infection
Rabbits, 72 females, weighing (1.9.+ -. 0.5) kg, were randomly divided into 9 groups of 8 animals each. Except for the blank group, 0.1ml of candida albicans bacterial liquid (about 10 hundred million bacteria per ml) is extracted by an inoculation injection needle head and is injected into the vagina of the rabbit to a depth of about 3-4 cm, before bacterial liquid is injected, the needle head is clung to the front, back, left and right of the vagina to repeatedly advance and retreat for 7-8 times, so that local damage of vaginal mucosa is caused, and then bacterial liquid is injected. Starting 24h after fungus inoculation, continuously injecting distilled water into the vagina of the rabbit in each d blank group and model group for 7d, and respectively using 0.5g of sample 1 to sample 6 and clotrimazole suppository to smear the inner wall of the vagina of the rabbit in each other group. After the treatment is finished, the local secretion of vagina is adopted to detect fungi and the fungi are cultivated. The results are shown in Table 3.
Table 3: therapeutic effect of rabbit vaginal mucosa artificial fungus infection
From the above experimental results, it is shown that the treatment effects of sample 1, sample 2, sample 5, sample 7 and clotrimazole suppository group are relatively good, and the fungi are substantially disappeared.
Rabbit vaginal fungus infection recurrence rate experiment
The rabbits of each group after the treatment period are continuously fed for 14 days, and the rabbits are normally eaten and active. After 14d, the animals are sacrificed for examination of vaginal smear, local secretion of vagina is adopted for fungus culture, and finally, the vagina is examined for pathological section. The experimental results are shown in Table 4.
Table 4: the recurrence of the rabbit vaginal mucosa artificial fungus infection.
The experimental results of the table show that the mycotic vaginitis does not recur after two weeks of treatment of the rabbits using the sample 1 obtained by the invention, and the inner wall of the vagina is not inflamed according to pathological sections; other groups have different degrees of recurrence, probably because the strong adhesiveness of mussel mucin mfp-5 prolongs the action time of the gel on the affected part, the common parameters of mussel mucin mfp-5 and madecassic acid have synergistic effect, and mussel mucin mfp-5 and madecassic acid with repair effect lead the gel to have better anti-inflammatory effect and repair capability. The mussel mucin mfp-5 of the invention can be extracted naturally, or can be expressed from escherichia coli, yeast or CHO cells, separated and purified.
The pH value of the vagina is acidic in a healthy state, and too high pH value of the gel can unbalance the pH value of the vagina, so that the antibacterial effect is affected. The adhesion of mussel mucin is enhanced with the increase of pH, and the adhesion of mussel mucin is reduced at low pH in the intravaginal environment, whereas mussel mucin mfp-5 is the most adhesive mussel mucin with high DOPA content. When mussel mucin mfp-5 is used as gel, the general pH value is not less than 7, and the higher the pH value is, the better the adhesion performance is, but the too high pH value of the gel of the patent can unbalance vaginal acid and alkali, so that the antibacterial effect is affected. The mussel mucin mfp-5 content and the specific proportion of the mussel mucin mfp-5, matrine and madecassic acid are adopted in the preparation, so that the gel can still keep a strong adhesion effect in a low-pH environment, and the action time of the gel on an affected part can be prolonged relative to the gel using common mussel mucin, so that the antibacterial effect is better, and the recurrence of vaginitis after healing is prevented.
Heavy metal detection of antibacterial gel:
1. equipment and method for manufacturing the same
1. Test sample: sample 1 obtained in example 1;
2. instrument apparatus: atomic fluorescence photometer, model: BAF-2000; atomic absorption spectrophotometer, model: AA-6880F/AAC; electronic balance, model: JA5003N.
3. Standard solution and concentration: mercury standard solution (10 ug/L); arsenic standard solution (100 ug/L); lead standard solution (50 mg/L).
2. Method of
The detection basis is as follows: first method of 1.2 mercury of the fourth chapter of cosmetic safety technical Specification (2015 edition); 1.4 arsenic first method; 1.3 lead second method.
3. Results
The heavy metal test results of the samples are shown in Table 6
TABLE 5 heavy metal test results for samples
4. Conclusion(s)
The mercury content of the gynecological antibacterial gel of the sample 1 is 0.002mg/kg, the arsenic content is 0.02mg/kg, and the lead content is less than 1.5mg/kg.
And (3) detecting the PH value of the gynecological antibacterial gel:
1. equipment and method for manufacturing the same
1. Test sample: sample 1 obtained in example 1;
2. instrument apparatus: acidimeter, model: PHS-25.
3. Standard buffer solution for calibration:
potassium hydrogen phthalate solution PH (25 ℃) =4.00
Phosphate buffer PH (25 ℃) =6.
Borate standard buffer PH (25 ℃) =9.18
2. Method of
1. The detection basis is as follows: determination of the value 2.2.1.4PH of the disinfection Specification (2002 edition).
2. Detection conditions: the ambient temperature was 27.2 ℃ and the relative humidity was 64%. Number of test replicates: 2 times.
3. Sample detection: the pH of the sample was measured directly (25 ℃).
3. Results
The pH (25 ℃) of this sample was 4.30 as tested and the results are shown in Table 6.
TABLE 6 PH (25 ℃) test results of gynecological antibacterial gel
4. Conclusion(s)
The pH (25 ℃) of the gynecological antibacterial gel of sample 1 of the example of the invention was 4.30.
Claims (6)
1. A gynecological antibacterial gel comprises matrine, a repairing agent, a gel matrix and an adhesive with a repairing function, and is characterized in that the adhesive with the repairing function is mussel mucin, and the mussel mucin is mussel mucin mfp-3 or mussel mucin mfp-5; the repairing agent is madecassic acid, and the matrine is 4% matrine ethanol solution;
the gynecological antibacterial gel comprises the following components: 2% -5% of 4% matrine ethanol solution, 0.5% -2% of madecassic acid, 0.1% -0.3% of mussel mucin, 0.3% -1% of carbomer and purified water.
2. A gynecological antibacterial gel according to claim 1, wherein the PH of the gynecological antibacterial gel is 4.1-4.5.
3. A gynecological antibacterial gel according to claim 1, further comprising other adjuvants, said other adjuvants being fragrances and PH adjusting agents.
4. The gynecological antibacterial gel according to claim 1, wherein the mass ratio of matrine, madecassic acid and mussel mucin is 3:1:0.2.
5. a gynecological antibacterial gel according to claim 1, which is prepared from the following components: 3.0% of 4% matrine ethanol solution, 1.0% of madecassic acid, 0.2% of mussel mucin mfp-5, 0.6% of carbomer, 0.02% of other auxiliary materials and the balance of purified water.
6. Use of a gynecological antibacterial gel according to any one of claims 1 to 5 in the preparation of a medicament for the treatment of recurrent mycotic vaginitis.
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