CN112618575A - anti-HPV lactic acid bacteria gynecological mousse lotion and application thereof - Google Patents
anti-HPV lactic acid bacteria gynecological mousse lotion and application thereof Download PDFInfo
- Publication number
- CN112618575A CN112618575A CN202110035005.8A CN202110035005A CN112618575A CN 112618575 A CN112618575 A CN 112618575A CN 202110035005 A CN202110035005 A CN 202110035005A CN 112618575 A CN112618575 A CN 112618575A
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- CN
- China
- Prior art keywords
- mousse
- gynecological
- lotion
- hpv
- vaginitis
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
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- A—HUMAN NECESSITIES
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
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- Communicable Diseases (AREA)
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- Gynecology & Obstetrics (AREA)
- Biotechnology (AREA)
- Urology & Nephrology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a gynecological mousse lotion and application thereof. The gynecological mousse lotion comprises plant extracts, 1, 3-butanediol, cocamidopropyl betaine, glycerol, lactobacillus fermentation liquor and water, wherein the plant extracts at least comprise extracts of one or two of radix sophorae flavescentis and cortex phellodendri. The invention is safe, natural and returns to the essential raw materials; the product has the effects of resisting HPV, inhibiting bacteria, preventing and treating vaginitis, and facilitating daily prevention and maintenance of women.
Description
Technical Field
The invention relates to the technical field of biological pharmacy, in particular to an anti-HPV lactobacillus gynecological mousse lotion and application thereof.
Background
Vaginitis is common genital inflammation of women, and more than half of married women suffer from vaginitis of different degrees. In traditional medicine, there is no corresponding term to vaginitis, but from the aspect of its symptoms, vaginitis belongs to the categories of "pruritus vulvae" and "leukorrhagia", and is mostly caused by downward flow of damp-heat. The traditional Chinese medicine preparation such as lotion, vaginal tablet, vaginal suppository and the like at present have the defects of inconvenience in use, small contact area, poor absorption, large side effect, easy cross infection and the like. Therefore, the search for a prescription which has definite curative effect, low side effect and convenient use has great significance.
In recent decades, Chinese medicine has made great progress in the treatment of vaginitis. Vaginitis is mainly characterized by local diseases in external aspect, so the treatment measures are mainly external treatment and auxiliary internal treatment. In the field of external therapies, many new methods have been developed in recent years and many dosage forms have been developed, such as lotions, suppositories, vaginal tablets, powders and capsules, and the like. At present, the traditional Chinese medicine method for treating vaginitis mainly comprises an external treatment method, an internal treatment method and an internal and external combination therapy.
More than 30 kinds of gram-positive bacteria, gram-negative bacteria, bacillus and other microorganisms (such as mycoplasma hominis, yeast, mycoplasma urealyticum, etc.) exist in vagina. The largest number of normal vaginal flora is lactobacilli, which account for about 95% of all flora and coexist with other flora. Under normal conditions, estrogen secreted by the ovary causes the vaginal epithelium to be proliferated and thickened and rich in glycogen, the resistance to pathogens is increased, the glycogen can be decomposed into lactic acid under the action of lactobacillus vaginalis, the normal acidic environment of the vagina is maintained (the pH is below 4.5, and most of the glycogen is 3.8-4.4), so that pathogenic bacteria are inhibited, and a balance is formed between the vagina and the bacteria.
In daily life, however, this balance can be undermined by a number of factors. Factors influencing the vaginal microenvironment mainly comprise vaginal pH value, hormone, change of flora in different periods, menstrual cycle, pregnancy, contraceptive tools, vaginal wall bioelectric potential, menstruation articles, sexual intercourse (the strong basicity of seminal fluid lubricating mucus can not restore the vaginal pH value to normal within 8h after sexual intercourse), vaginal irrigation, cervical operation, medicines (antibiotics, immunosuppressants and the like are used), reduction of lactobacilli for maintaining vaginal balance, hypothyroidism, anemia, infection factors and the like. Once this balance is broken, vaginitis follows.
At present, the vaginitis is roughly divided into more than ten kinds clinically, such as bacterial vaginitis, trichomonas vaginitis, candida vaginitis, senile vaginitis, infantile vaginitis, candida vaginitis, viral HSV, HPV vaginitis, gonococcal vaginitis, desquamative vaginitis, non-specific vaginitis, tuberculous vaginitis, drug vaginitis, radiation vaginitis, vaginal ulcer acute, allergic vaginitis, chronic vaginitis, enterobiasis and the like, and more than half of the clinical vaginitis belongs to a mixed type.
Regarding the prevalence of HPV infection of the female genital tract, a survey of the national health and nutrition research topic from the United states in 2003-2004 showed that the total HPV infection rate was 26.8% between 14 and 59 years old, so that HPV infection was more than estimated before in women. Epidemiological screening of HPV infection in China is not reported in large samples, but the incidence rate of condyloma acuminatum in venereal diseases caused by HPV infection is rapidly increased, and the estimated incidence rate is the most severe of the venereal diseases because of a great amount of reports and reports. About 13.15 million newly discovered cervical cancers are present in China every year, the morbidity and mortality rate in the report are increased, the age of the onset of the cervical cancer is younger, and the huge loss caused in China by HPV infection can be expected
Disclosure of Invention
According to one aspect of the invention, a gynecological mousse lotion is provided, which comprises a plant extract, 1, 3-butanediol, cocamidopropyl betaine, glycerol, lactic acid bacteria fermentation broth and water, wherein the plant extract at least comprises an extract of one or both of radix sophorae flavescentis and cortex phellodendri.
According to the gynecological mousse lotion, clinical tests of plant extracts show that the lotion has inhibitory effect on HPV, menthol has good cool body feeling, lactobacillus fermentation liquor contains rich antibacterial peptide, cocoamidopropyl betaine is used as a foaming agent, and glycerin has good moisture retention; is mainly used for treating and preventing vaginitis. The prescription has good curative effect on vaginitis, small toxic and side effect and no anaphylactic reaction to patients. Not only can effectively treat and prevent vaginitis, but also avoids pollution and cross infection in the using process of the medicine to a great extent.
In some embodiments, the gynecological mousse lotion comprises, in weight percent: 3-10% of plant extract, 1-5% of 1, 3-butanediol, 3-10% of cocamidopropyl betaine, 5-15% of glycerol, 2-10% of lactobacillus fermentation liquor and 60-80% of water.
In some embodiments, the gynecological mousse lotion comprises, in weight percent: the plant extract comprises 5% of plant extract, 2% of 1, 3-butanediol, 5% of cocamidopropyl betaine, 10% of glycerol, 5% of lactobacillus fermentation liquor and 73% of water.
In some embodiments, the plant extract comprises at least one or two of matrine and phellodendrine as an active ingredient.
According to another aspect of the invention, there is provided the use of a gynaecological mousse lotion in a product for the treatment and prevention of vaginitis.
Application of gynecological mousse lotion in products for inhibiting candida albicans and staphylococcus aureus.
Application of gynecological mousse lotion in anti-HPV gynecological products.
According to the technical scheme, the product is novel in form and is mousse lotion; the product components (plant extract and lactobacillus fermentation liquor) are safe, natural and return to the essential raw materials; the product has the effects of resisting HPV, has good bacteriostatic effect, has the effect of preventing and treating vaginitis, and is an effective product for daily prevention and maintenance of women.
Drawings
FIG. 1 is a flow chart of a bacteriostatic ring experiment;
fig. 2 is a bacteriostatic graph of the gynecological mousse lotion against candida albicans and staphylococcus aureus according to an embodiment of the invention.
Detailed Description
Example 1 preparation of gynecological mousse lotion
The reagents used are commercially available and are commercially available. Lactobacillus fermentation broth, produced by the unit itself.
The preparation method of the lactobacillus fermentation liquor comprises the following steps:
inoculating Bacillus bifidus working seed into TPY liquid culture medium, culturing at 37 deg.C for 18-24 hr, centrifuging, and collecting supernatant, i.e. lactobacillus fermentation liquid
Table 1 ingredient ratio
The preparation method comprises the steps of heating and dissolving menthol, 1, 3-butanediol and glycerol, adding lactobacillus fermentation liquor, plant extract and cocamidopropyl betaine, and finally adding water for cooling.
Example 2 technical selection and bacteriostatic experiment of gynecological mousse lotion
The details are as follows:
the instrument equipment comprises:
YF-40 pressureless circulation decocting machine (Beijing Donghua medical equipment, Limited liability company), HH-2 digital display constant temperature water bath (Jiangnan Instrument factory, Jintancity), and constant temperature incubator (Shanghai-Heng).
The theoretical basis of the extraction process design is as follows:
according to the physicochemical properties and action mechanisms of different plant active ingredients in the prescription, a proper process is selected for extracting the plants. All the plants can be decocted with water to extract effective components according to conventional method.
Selecting a plant water extraction process:
determination of factors
The extraction is carried out by a water decoction method, and factors influencing the extraction effect comprise water addition amount, decoction times and decoction time.
Selection of the quantity of water to be added
The plants are immersed by taking the amount of the plants in the prescription and adding 8 times of water, so that the amount of the water is selected to be 8 times, 10 times and 12 times of the amount of the plants.
And (3) selecting time:
considering that the decoction time is too short in large production, the effective components are not easy to be completely extracted, the extraction time is too long, time is consumed, and the cost is increased, the extraction time is selected to be three times, namely 1.5h, 2h and 2.5 h.
Selection of the number of times
Selecting according to general method, decocting for 1 time, 2 times and 3 times respectively.
Experimental animals:
healthy and early-adult female white rabbits with the same strain and the weight of 2.0 kg-2.5 kg are selected. Before the test, the vaginal orifice of the animal should be checked for the presence of secretions, congestion, edema and other lesions. If inflammation or (and) injury occurs, it should be discarded. Preferably, the animal is selected for non-estrus testing.
Grouping tests:
the test is divided into a virus infection group and a control group, and each group comprises 3 animals.
TABLE 2 vaginal mucosal irritation response Scoring criteria
Stimulation response integral ═ A + B + C + D
The operation procedure is as follows:
(1) the disinfectant used for dilution adopts a solution with 5 times concentration of the application solution in mucous membrane disinfection as a test solution. If the application liquid is the disinfectant of the stock solution, the stock solution is used as the test liquid. The control group was saline.
(2) A blunt tip hose about 8cm in length was connected to a 2ml syringe. The syringe and the catheter are filled with the test solution for standby. One set was prepared for each animal.
(3) The contamination method of one vaginal mucosa stimulation test comprises the following steps: the animal is fixed on its back to expose perineum and vaginal opening. The catheter is moistened by test solution or control solution and then is inserted into the vagina (4 cm-5 cm) gently, 2ml of test solution is slowly injected by a syringe, and the catheter is drawn out to finish the contamination. Control animals were treated with saline as well.
(4) The contamination method of the multiple times of vaginal mucosa stimulation test comprises the following steps: according to the contamination method, the contamination is repeated every 24h for 5 days continuously. Control animals were treated with saline as well.
(5) Due to individual differences in vaginal volume of animals, sometimes the test solution may spill after injection and be wiped off with a sterilized cotton or soft paper.
(6) 24h after the last infection, the animals are killed by an air embolism method, the whole vagina is taken out after laparotomy, the longitudinal incision is carried out, and whether congestion, edema and other manifestations exist or not is observed by naked eyes for reference when pathological materials are obtained. Then the vagina is put into 10 percent formalin solution for fixation for more than 24 hours, tissues at two ends and 3 parts in the center of the vagina are selected for flaking, and histopathological examination is carried out after HE staining.
And (4) evaluating the results:
(1) histopathological examination results, the stimulation response of the vaginal mucosa was scored as specified in table 2.
(2) The stimulation response scores of 3 sites of 3 animals in the test group were added and divided by the total number of observations (number of animals x 3) to obtain the average score of the vaginal mucosa stimulation response in the test group, with the maximum score of 16 (see table 1). The control scoring method was as above.
(3) The stimulation index was obtained by subtracting the average integral of the control group from the average integral of the test group, and then the stimulation intensity was graded as shown in table 2.
(4) When the average integral of the vaginal mucosa stimulation response of the animals in the control group is more than 9, 6 animals are adopted for retesting to identify whether the control group is related to the operation injury.
TABLE 3 vaginal mucosal irritation Strength grading
And (3) bacteriostatic test:
the 24h slant culture of the test bacteria was washed with PBS to prepare a bacterial suspension (20. mu.l of wash solution was dropped into 10ml PBS solution, 100. mu.l of wash solution was dropped into 5ml PBS solution (the required concentration was 5X 105 cfu/ml-5X 106cfu/ml), and the experimental flow chart of bacteriostatic loop is shown in FIG. 1.
Sucking 1.0ml of the culture medium, placing the culture medium in 2 plates, pouring 15ml of nutrient agar culture medium or Sabouraud's agar culture medium (yeast) cooled to 40-45 deg.C, rotating the plates to make them fully and uniformly, after the agar is solidified, turning over the plate, culturing at 37 deg.C +/-1 deg.C for 48 hr (bacteria) or at 35 deg.C +/-2 deg.C for 72 hr (yeast), and counting the bacterial colony as viable bacteria.
Bacteriostatic operation process
(1) The antibacterial tablet is prepared by taking sterile and dried filter paper as liquid antibacterial agent. Dripping 20 μ l of bacteriostatic agent solution with practical use concentration into each piece, placing the filter paper piece in a clean sterile plate, opening the cover, and oven drying in a warm box (37 deg.C), or naturally drying at room temperature for use.
The dissoluble antibacterial product can be directly made into round pieces (blocks) with the diameter of 5mm and the thickness of not more than 4mm, and every 4 round pieces (blocks) are in a group.
(2) And (3) preparing a negative control sample sheet, namely taking a sterile dry filter paper sheet, dropwise adding 20 mu l of sterile distilled water into each sheet, and drying for later use.
The negative control sample of the dissoluble antibacterial product is prepared by taking a sample which is made of the same material and does not contain the antibacterial component, and preparing a sample slice (block) with the same size as the test group.
(3) And (3) inoculating the test bacteria, namely dipping the test bacteria suspension with the concentration of 5 multiplied by 105cfu/ml to 5 multiplied by 106cfu/ml by using a sterile cotton swab, and uniformly smearing the test bacteria suspension on the surface of a nutrient agar culture medium plate for 3 times. For each application 1 time, the plate should be rotated 60 °, and finally the cotton swab is applied around the edge of the plate for one revolution. The plate was covered and dried at room temperature for 5 min.
(4) And (3) sticking bacteriostatic agent sample sheets, namely sticking 1 bacteriostatic flat plate on each test, sticking 4 test sample sheets and 1 negative control sample sheet on each flat plate, and sticking 5 negative control sample sheets. A sample was taken with sterile forceps and placed on the surface of the plate. The distance between the centers of the various pieces is more than 25mm, and the distance between the centers of the various pieces and the periphery of the flat plate is more than 15 mm. After the sample is placed, the sample is lightly pressed by using sterile tweezers to be tightly attached to the surface of the flat plate. The plate is covered, the plate is placed in an incubator at 37 ℃, and the result is observed after the plate is cultured for 16 to 18 hours. The diameter of the antibacterial ring (including the patch) was measured with a vernier caliper and recorded. The experiment was repeated 3 times.
When the inhibition zone is measured, the inhibition zone which is uniform and completely aseptically grows is selected for measurement. The diameter of the catheter is measured by taking the outer edge of the bacteriostatic ring as a boundary.
Table of results of orthogonal tests
Orthogonal experiments were performed according to the orthogonal experiment software design table, and the calculation results are shown in the following table, in which ABCD represents the amount of water added, the number of times of decoction, the time of decoction, and the error (%). The conclusion shows that the optimal conditions obtained by performing the variance analysis by taking the dry paste amount as an index are A3B3C 2. From this result, the main factors affecting the water decoction are the number of times of decoction B, the time of decoction C, and the amount of water addition A, and the optimal process is determined as A3B3C2, wherein the amount of water addition is 12 times of that of the plants, the number of times of decoction is 3, and the time of each time of decoction is 2.0 h.
TABLE 4 Water decoction orthogonal test and dry paste result analysis table
1.3-butanediol one-factor test
TABLE 51.3 butanediol monofactor
According to the experimental result, when the addition amount is 2g, the moisturizing effect and the moistening effect reach the optimal effect.
Cocamidopropyl betaine one-factor test
Common blowing agents are some surfactant-type materials. Wherein, the foaming effect of the cocamidopropyl betaine is relatively better, and the cocamidopropyl betaine is selected as the foaming agent. The cocamidopropyl betaine is white powder, is easily dissolved in water, and has good emulsifying and foaming properties.
TABLE 6 Cocamidopropyl betaine Single factor
According to the experimental result, when the addition amount of the cocamidopropyl betaine is 5g, the foam appearance is fine and smooth, and the foaming volume is large.
Glycerol one-factor test
Glycerol is colorless transparent viscous liquid, is safe and nontoxic, has good moisturizing and moistening effects, has insufficient viscosity, directly influences the foaming effect, selects glycerol as a thickening agent, and has the function of dissolving assistance in the formula. We made the following prescription study on the amount of glycerol.
TABLE 7 Glycerol monofactor
According to the experimental result, when the dosage of the glycerol is 10g, the foam has fine appearance, large foaming volume and proper duration, so that l0g is selected as the dosage of the prescription.
Experiment for testing stimulation response intensity of anti-HPV (human papillomavirus) lactobacillus mousse lotion on rabbit vaginal mucosa by visual observation
Both are shown to be non-irritating. No clinical manifestations of pain symptoms of the vagina part of the rabbits, vaginal bleeding, mucus secretion and the like are found in the administration period of the rabbits of the administration group and the control group, vaginal specimens are dissected, only individual specimens are observed by naked eyes and have mild hyperemia, no obvious pathological changes such as edema, erosion, bleeding, ulcer and the like are seen, the average stimulation response score of the vaginal mucosa is 0.25, stimulation intensity evaluation is a non-irritant histopathology microscopic examination result, the stimulation index of HPV lactobacillus mousse lotion to the vaginal mucosa of the rabbits is 0.5, and the stimulation response degree is non-irritant.
Stability test
Appearance character
By visual observation, the product is brown liquid, and has faint scent and slightly pungent taste. The jet is light yellow uniform fine foam. .
pH value
The pH value is determined according to the 'pH value' in the appendix VIG of the first part of Chinese pharmacopoeia of 2005 edition, and the result specifies that the pH value is between 3.4 and 5.4.
Accelerated test
Taking three batches of samples of 1, 2 and 3 of the anti-HPV lactobacillus mousse washing liquid, placing the samples in a constant-temperature and constant-humidity box with the relative humidity of 75 +/-5% and the temperature of 40 +/-and performing examination in 0 month, 1 month, 2 months and 3 months respectively.
TABLE 8 accelerated test
Experiment of bacteriostatic Ring
The left graph is a bacteriostatic ring graph of the anti-HPV lactobacillus mousse lotion on Candida albicans, the right graph is a bacteriostatic graph of the anti-HPV lactobacillus mousse lotion on Staphylococcus aureus, and the two bacteriostatic rings are both larger than 7mm and have better bacteriostatic activity. As shown in fig. 2.
anti-HPV test data supplementation
The method comprises the following steps:
64 patients suffering from cervicitis and HPV infection are selected for clinic visit of gynecology, and are divided into 32 experimental groups and 32 control groups according to the ratio of 1:1 by adopting an open random control experimental design method.
The selection standard is (1) 18-50 years old for female; (2) meets the diagnosis standard of chronic cervicitis; (3) positive for vaginal secretion HPV virus detection; (4) TCT (liquid-based thin layer cell assay) negative; (5) voluntarily attend the clinical trial and sign informed consent.
Exclusion criteria (1) patients with mycotic vaginitis, trichomonas vaginitis, sexually transmitted diseases, CIN and cervical cancer; (2) irregular menstruation of non-menopausal women, including those with a menstrual period of greater than 7 days or a menstrual cycle of <25 days or a menstrual cycle of >40 days; (3) patients with primary diseases such as heart, liver, kidney or hemopoietic system, and psychosis; (4) pregnant or lactating women; (5) allergic constitution or allergic to the product, recombinant human interferon alpha 2a or such components; (6) the patients who are treated by anti-inflammatory and antiviral drugs within 1 week before the administration of the medicine; (7) other clinical trials were conducted within 1 month; (8) women who have not had sexual life (virgo); (9) researchers considered it inappropriate to conduct clinical trials.
Method of treatment
The patients in the test group were administered an anti-HPV lactobacillus mousse lotion in a manner that the lotion was applied to the vaginal exterior and washed before sleeping every night. The control group patients were administered recombinant human interferon alpha 2a suppository (Wuhanweiao pharmaceutical Co., Ltd., specification 6 ten thousand IU/granule) which was applied to the posterior fornix of vagina 1 tablet at a time 1 time every other day before sleeping. The treatment course is 14 days.
Criteria for judging therapeutic effect
The medicine is cured according to (1), the medicine symptoms and physical signs basically disappear, and the integral value is reduced by more than or equal to 90.5 percent; (2) has obvious effect, the symptoms and physical signs of the medicine are obviously improved, and the integral value is reduced by more than or equal to 60 percent; (3) effective, the medicine symptoms and physical signs are improved, and the integral value is reduced by more than or equal to 30.5 percent; (4) no effect, no obvious improvement of drug-taking symptoms and signs, and the integral value reduction is less than 29 percent. And (4) converting the HPV detection result into negative rate.
As a result:
(1) total effective rate of comprehensive therapeutic effect
The total effective rate of the comprehensive curative effect of two groups of patients after 14 days of treatment is 92.5% (N is 13) in the test group and 89.6% (N is 32) in the control group, the difference between the two groups is compared by adopting a continuous correction chi-square test, the P value is greater than 0.05, namely the effective rate difference between the two groups has no statistical significance (table 1), the difference between the test group and the control group is 2.9%, the lower limit of a 95% confidence interval of the difference is-11.4%, and the lower limit is greater than-15% of a non-poor effect threshold, so that the test group is considered to be not inferior to the control group (table 2).
TABLE 9 Total effective rate of the combined treatment effect of two groups of patients after 14 days
TABLE 1014 days Total efficacy Total 95% confidence Interval (ITT)
(2) Percentage of symptom efficacy analysis
After 7 days of treatment, the effective rate of the test group is 22.6 percent higher than that of the control group (19.4 percent), and after 14 days of treatment, the effective rate of the test group is 54.8 percent higher than that of the control group (28.1 percent), the CMH chi-square result P values of 7 days and 14 days of symptom curative effect percentage analysis between two groups are both more than 0.05, and the difference of the 7 days and 14 days of symptom curative effect percentage between the two groups has no statistical significance (Table 3).
TABLE 11 percentage of symptom efficacy analysis (ITT)
Remarking: the total symptom score after the cure is reduced by more than or equal to 90 percent compared with the baseline. The total symptom score after treatment is reduced by more than or equal to 60 percent compared with the baseline.
The total symptom score after treatment is reduced by more than or equal to 30 percent compared with the baseline. Total symptom score decreased < 30% from baseline after treatment.
(3) HPV negative conversion rate
After 14 days of treatment, the negative conversion rate of the test group HPV is 11.1 percent lower than that of the control group.
TABLE 1214 days HPV negative conversion assay (ITT)
And (4) conclusion:
the experimental research shows that the total effective rate of the anti-HPV lactobacillus mousse lotion for treating chronic cervicitis and HPV infection can reach more than 90 percent, and the anti-HPV lactobacillus mousse lotion is not inferior to recombinant human interferon alpha 2a suppository. After 7 days and 14 days of treatment, the effective rate of the symptom curative effect of the anti-HPV lactobacillus mousse washing liquid is obviously higher than that of the recombinant human interferon alpha 2a suppository. In the research, the negative conversion of HPV is lower than that of interferon alpha 2a suppository, but the HPV still has certain curative effect on negative conversion, and can be continuously researched in the later experiments. Through research, the HPV lactobacillus mousse lotion can be used as a new means for clinically treating chronic cervicitis complicated with HPV virus infection, and a new choice which is more effective, safer and more economical is found for patients suffering from chronic cervicitis complicated with HPV infection.
The orthogonal test is carried out on the extraction to be obtained, and the optimal extraction process is determined to be that the water adding amount is 12 times of that of the plant, the extraction is carried out for 3 times, and the extraction effect is optimal after 2 hours of extraction each time; single-factor tests are carried out on 1, 3-butanediol, cocamidopropyl betaine and glycerol, and the HPV lactobacillus mousse lotion is determined to have the best body feeling when the addition amount of the 1, 3-butanediol is 2%, the cocamidopropyl betaine is 5% and the glycerol is 10%; the stimulation index of the HPV lactobacillus mousse lotion to the vaginal mucosa of the rabbit is 0.5, and the stimulation reaction degree is no stimulation; and carrying out stability test on the HPV lactobacillus mousse washing liquid; the HPV lactobacillus mousse lotion has a good inhibition effect on Candida albicans and Staphylococcus aureus, brings gospel to the majority of female patients, and provides a theoretical basis for industrial production of the product.
What has been described above are merely some embodiments of the present invention. It will be apparent to those skilled in the art that various changes and modifications can be made without departing from the inventive concept thereof, and these changes and modifications can be made without departing from the spirit and scope of the invention.
Claims (7)
1. A gynecological mousse lotion is characterized by comprising a plant extract, 1, 3-butanediol, cocamidopropyl betaine, glycerol, a lactic acid bacteria fermentation liquor and water, wherein the plant extract at least comprises an extract of one or two of radix sophorae flavescentis and cortex phellodendri.
2. The gynecological mousse lotion according to claim 1, which comprises the following components in percentage by weight: 3-10% of the plant extract, 1-5% of 1, 3-butanediol, 3-10% of cocamidopropyl betaine, 5-15% of glycerol, 2-10% of lactobacillus fermentation liquor and 60-80% of water.
3. The gynecological mousse lotion according to claim 2, which comprises the following components in percentage by weight: 5% of the plant extract, 2% of the 1, 3-butanediol, 5% of the cocamidopropyl betaine, 10% of the glycerol, 5% of the lactic acid bacteria fermentation liquor and 73% of water.
4. The gynecological mousse lotion according to claim 1, wherein the plant extract comprises at least one or two of matrine and phellodendrine as an effective ingredient.
5. A gynecological mousse lotion according to claims 1-4 for use in products for treating and preventing vaginitis.
6. A gynecological mousse lotion according to claims 1-4 for use in products inhibiting Candida albicans and Staphylococcus aureus.
7. A gynecological mousse lotion according to claims 1-4, for use in anti-HPV gynecological products.
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| CN1718197A (en) * | 2004-07-09 | 2006-01-11 | 湖南一泰中南医药研究有限公司 | Pharmaceutical composition contg .bifidobacterium, prepn. method and medical use thereof |
| CN108888758A (en) * | 2018-07-02 | 2018-11-27 | 西安巨子生物基因技术股份有限公司 | Collagen gynaecologic washing lotion and preparation method thereof |
| CN109078165A (en) * | 2018-10-26 | 2018-12-25 | 广东卓明仕生物科技有限公司 | A kind of composition and the preparation method and application thereof for the nursing of women privates |
| CN111658564A (en) * | 2020-05-26 | 2020-09-15 | 李时珍医药集团有限公司 | Gynecological vulva foam lotion and preparation method thereof |
| US20200345798A1 (en) * | 2019-05-03 | 2020-11-05 | Nam Soo PAEK | Lactobacillus having antimicrobial effect on gardnerella vaginalis and candida albicans |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1718197A (en) * | 2004-07-09 | 2006-01-11 | 湖南一泰中南医药研究有限公司 | Pharmaceutical composition contg .bifidobacterium, prepn. method and medical use thereof |
| CN108888758A (en) * | 2018-07-02 | 2018-11-27 | 西安巨子生物基因技术股份有限公司 | Collagen gynaecologic washing lotion and preparation method thereof |
| CN109078165A (en) * | 2018-10-26 | 2018-12-25 | 广东卓明仕生物科技有限公司 | A kind of composition and the preparation method and application thereof for the nursing of women privates |
| US20200345798A1 (en) * | 2019-05-03 | 2020-11-05 | Nam Soo PAEK | Lactobacillus having antimicrobial effect on gardnerella vaginalis and candida albicans |
| CN111658564A (en) * | 2020-05-26 | 2020-09-15 | 李时珍医药集团有限公司 | Gynecological vulva foam lotion and preparation method thereof |
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