CN114652773A - Gynecological gel and preparation method and application thereof - Google Patents
Gynecological gel and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a gynecological gel and a preparation method and application thereof, and belongs to the technical field of medicines. The gynecological gel is prepared from the following raw materials in parts by weight: 1-20 parts of polygonatum polysaccharide, 1-20 parts of pachymaran, 94010-20 parts of carbomer, 30-100 parts of aloe gel, 150-250 parts of glycerol, 0.1-10 parts of cinnamon volatile oil, 0.1-10 parts of houttuynia volatile oil, 0.1-10 parts of clove volatile oil, 10-20 parts of L-menthol, 10-20 parts of lactobacillus rhamnosus, 0.1-10 parts of ethylparaben, 20-80 parts of 95% ethanol and 150-250 parts of water. The gynecological gel prepared by the invention has obvious antibacterial and anti-inflammatory effects and is suitable for industrial popularization and application.
Description
Technical Field
The invention belongs to the technical field of medicines, particularly relates to a gynecological gel and a preparation method thereof, and discloses application of the gynecological gel in bacteriostasis and anti-inflammation in the field of medicines.
Background
The gynecological infectious diseases are common diseases and frequently encountered diseases, particularly the incidence rate of mycotic vaginitis, cervical erosion and senile vaginitis is high, at present, the vaginitis is mainly treated by adopting antibiotic medicines, and the cervical erosion is mainly treated by adopting physical and operative therapies. After long-term use of antibiotic drugs, drug resistance can be generated, so that vaginal flora is disordered; and physical or surgical therapy has wound on human body, cervical secretion capacity is reduced, and vagina defense barrier is damaged, thus seriously affecting sexual life and reproductive health.
Therefore, the technical problem to be solved by those skilled in the art is how to provide a safe and effective gynecological gel with bacteriostatic and anti-inflammatory effects.
Disclosure of Invention
In view of the above, the present invention aims to provide a gynecological gel with antibacterial and anti-inflammatory effects, which is directed to the problems in the prior art.
In order to achieve the purpose, the invention adopts the following technical scheme:
the gynecological gel is prepared from the following raw materials in parts by weight:
1-20 parts of polygonatum polysaccharide, 1-20 parts of pachymaran, 94010-20 parts of carbomer, 30-100 parts of aloe gel, 150-250 parts of glycerol, 0.1-10 parts of cinnamon volatile oil, 0.1-10 parts of houttuynia volatile oil, 0.1-10 parts of clove volatile oil, 10-20 parts of L-menthol, 10-20 parts of lactobacillus rhamnosus, 0.1-10 parts of ethylparaben, 20-80 parts of 95% ethanol and 150-250 parts of water.
It is to be noted that the polygonatum polysaccharide and pachyman in the gynecological gel component have the function of enhancing the immunity of the organism; the herba Houttuyniae volatile oil has antiviral, antiinflammatory, and immunity enhancing effects; cortex Cinnamomi volatile oil has antipyretic, analgesic, antibacterial, and antifungal effects; the clove volatile oil has obvious antibacterial effect on Klebsiella oxytoca, Salmonella enteritidis, Shigella dysenteriae, Escherichia coli, Staphylococcus epidermidis and Staphylococcus aureus in vitro; has better therapeutic effect on mice infected by staphylococcus aureus, escherichia coli and the like in vivo.
In addition, the polysaccharide enhances the immunity, so that the resistance of the organism is improved, and the organism is prevented from being invaded by exogenous pathogenic factors; the volatile oil has antibacterial and anti-inflammatory effects, and can be used for treating gynecological diseases such as bacterial vaginitis and senile vaginitis.
The invention also aims to provide a preparation method of the gynecological gel.
In order to achieve the purpose, the technical scheme of the invention is as follows:
a preparation method of gynecological gel specifically comprises the following steps:
(1) weighing the raw materials according to the weight parts disclosed above, and adding water into rhizoma polygonati polysaccharide and pachyman to dissolve completely for later use;
(2) solution A: adding carbomer 940 and aloe gel into the liquid dissolved in the step (1), uniformly stirring, standing for 6-24 hours, and fully swelling for later use;
(3) and B, liquid B: dissolving L-menthol, cinnamon volatile oil, houttuynia volatile oil, clove volatile oil and ethylparaben in 95% ethanol, adding glycerol, and stirring;
(4) and adding the solution B into the solution A for a few times, adding lactobacillus rhamnosus, stirring while adding, homogenizing for 1-3 times by using a colloid mill after uniformly stirring, and filling to obtain the gynecological gel.
The invention also claims the application of the gynecological gel in the field of medicine.
According to the technical scheme, compared with the prior art, the gynecological gel and the preparation method and application thereof provided by the invention have the following excellent effects:
(1) the gynecological gel prepared from the pure natural traditional Chinese medicine volatile oil components is harmless to human bodies, and does not generate drug resistance and durability; and the results of bacteriostatic experiments show that the compound has stronger inhibiting effect on escherichia coli, candida albicans and staphylococcus aureus.
(2) The invention adjusts the vaginal micro-ecological environment and inhibits the growth of pathogenic microorganisms by adding the probiotic lactobacillus.
(3) The invention adopts the high molecular compound carbomer as a matrix, can maintain the stability of volatile oil active substances, and has affinity and protection effects on vaginal mucosa.
(4) The preparation process disclosed by the invention is simple and convenient to operate and is suitable for industrial mass production.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.
FIG. 1 shows the effect of different gynecological gels on vaginal histopathological morphology of New Zealand rabbits.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The embodiment of the invention discloses gynecological gel with antibacterial and anti-inflammatory effects and a preparation method thereof.
The present invention will be further specifically illustrated by the following examples for better understanding, but the present invention is not to be construed as being limited thereto, and certain insubstantial modifications and adaptations of the invention by those skilled in the art based on the foregoing disclosure are intended to be included within the scope of the invention.
The technical scheme of the invention will be further explained by combining specific experiments.
The contents of the present invention are not limited to the contents of the following experimental examples.
Example 1:
the formula is as follows: 1 part of polygonatum polysaccharide, 94010 parts of carbomer, 30 parts of aloe gel, 150 parts of glycerol, 0.1 part of cinnamon volatile oil, 0.1 part of houttuynia volatile oil, 0.1 part of clove volatile oil, 10 parts of L-menthol, 10 parts of lactobacillus rhamnosus, 0.1 part of ethylparaben, 20 parts of 95% ethanol and 150 parts of water.
The preparation method comprises the following steps: (1) weighing rhizoma Polygonati polysaccharide, and dissolving in water completely;
(2) solution A: carbomer 940, aloe gel, and the above rhizoma Polygonati polysaccharide solution by stirring, standing for 6 hr, and swelling;
(3) and B, liquid B: dissolving L-menthol, cinnamon volatile oil, houttuynia volatile oil, clove volatile oil and ethylparaben in 95% ethanol, adding glycerol, and stirring;
(4) adding the solution B into the solution A for a few times, adding lactobacillus rhamnosus while stirring, and homogenizing for 1 time by a colloid mill after stirring uniformly;
(5) and (5 g) filling, namely obtaining the gynecological gel.
Example 2:
the formula is as follows: 1 part of polygonatum polysaccharide, 1 part of pachyman, 94015 parts of carbomer, 40 parts of aloe gel, 180 parts of glycerol, 0.2 part of cinnamon volatile oil, 0.2 part of houttuynia volatile oil, 0.2 part of clove volatile oil, 15 parts of L-menthol, 15 parts of lactobacillus rhamnosus, 0.2 part of ethylparaben, 25 parts of 95% ethanol and 180 parts of water.
The preparation method comprises the following steps: (1) weighing rhizoma Polygonati polysaccharide and pachyman, and dissolving in water;
(2) solution A: adding carbomer 940, aloe gel, and above rhizoma Polygonati polysaccharide solution, stirring, standing for 12 hr, and swelling;
(3) and B, liquid B: dissolving L-menthol, cinnamon volatile oil, houttuynia volatile oil, clove volatile oil and ethylparaben in 95% ethanol, adding glycerol, and stirring;
(4) adding the solution B into the solution A for a few times, adding lactobacillus rhamnosus, stirring while adding, and homogenizing for 2 times by a colloid mill after stirring uniformly;
(5) and (5 g) filling, namely filling each bottle to obtain the gynecological gel.
Example 3:
the formula is as follows: 2 parts of polygonatum polysaccharide, 2 parts of pachyman, 94020 parts of carbomer, 50 parts of aloe gel, 200 parts of glycerol, 0.3 part of cinnamon volatile oil, 0.3 part of houttuynia volatile oil, 0.3 part of clove volatile oil, 20 parts of L-menthol, 0.3 part of ethylparaben, 30 parts of 95% ethanol and 200 parts of water.
The preparation method comprises the following steps: (1) weighing rhizoma Polygonati polysaccharide and pachyman, and dissolving in water;
(2) solution A: adding carbomer 940, aloe gel, and above rhizoma Polygonati polysaccharide solution, stirring, standing for 24 hr, and swelling;
(3) and B, liquid B: dissolving L-menthol, cinnamon volatile oil, houttuynia volatile oil, clove volatile oil and ethylparaben in 95% ethanol, adding glycerol, and stirring;
(4) adding the solution B into the solution A for a few times while stirring, and homogenizing by a colloid mill after uniformly stirring;
(5) and (5 g) filling, namely filling each bottle to obtain the gynecological gel.
To further verify that the gynecological gel prepared by the invention has excellent technical effects, the inventor also performs the following performance determination experiments:
in vivo experiments: comparative study of gynecological gels of different specifications on in-vivo antibacterial and anti-inflammatory effects of experimental rabbits
1. Purpose of the experiment
In the test, by establishing a staphylococcus aureus, escherichia coli and candida albicans mixed bacteria vaginitis model, the inhibition effect of the gynecological gel on staphylococcus aureus, escherichia coli and candida albicans is investigated, and a pharmacological basis is provided for the clinical application of the gynecological gel.
2. Test materials (to be noted, the following samples 1 to 3 correspond to the gynecological gel compositions and the preparation methods disclosed in the above examples 1 to 3, respectively)
2.1.1 test article 1
Name: gynecological gel 1
Batch number: 20210413
The characteristics are as follows: /
Specification: each pack is 5g
The validity period is as follows: 04 Yue 2023
Storage conditions are as follows: storing in shade, ventilated and dry place
The components: volatile oil of rhizoma Polygonati and cortex Cinnamomi
The functional indications are as follows: /
The clinical planned dose: /
The clinical proposed route: /
The clinical planned course of treatment: /
Production unit: research institute of traditional Chinese medicine of Hunan province
Providing a unit: research institute of traditional Chinese medicine of Hunan province
2.1.2 test article 2
The name is as follows: gynecological gel 2
Batch number: 20210903
The characteristics are as follows: /
Specification: each pack is 5g
The validity period is as follows: 09 months of 2023
Storage conditions are as follows: storing in shade, ventilated and dry place
The components: volatile oil of rhizoma Polygonati, Poria and cortex Cinnamomi
The functional indications are as follows: /
The clinical planned dose: /
The clinical proposed route: /
The clinical planned course of treatment: /
Production unit: research institute of traditional Chinese medicine of Hunan province
Providing a unit: research institute of traditional Chinese medicine of Hunan province
2.1.3 test article 3
Name: gynecological gel 3
Batch number: 20210904
The characteristics are as follows: /
Specification: each pack is 5g
The validity period is as follows: 09 months of 2023
Storage conditions are as follows: storing in shade, ventilated and dry place
The components: volatile oil of rhizoma Polygonati, Poria, cortex Cinnamomi, etc
The functional indications are as follows: /
Clinically planned doses: /
The clinical proposed route: /
The clinical planned course of treatment: /
Production unit: research institute of traditional Chinese medicine of Hunan province
Providing a unit: research institute of traditional Chinese medicine of Hunan province
2.2 vehicle control
Name: gel matrix
Providing a unit: hunan institute of traditional Chinese medicine
2.3 Positive control
Name: clotrimazole cream
Batch number: h44023928
Specification: 10 g/branch of clotrimazole, 0.03g of clotrimazole per g of clotrimazole cream
Production unit: guangdong Hengjian pharmaceutical Co Ltd
2.4 Experimental reagents
2.4.1 Experimental reagent 1
Name: metronidazole and sodium chloride injection
Batch number: 20211112A
Specification: 100 mL/bottle
The components: the main component is metronidazole, and the auxiliary materials are sodium chloride and the like
Action and use: has antibacterial and antiinflammatory effects
Production unit: guangdong Su Meitang sanitary products Co Ltd
2.4.2 Experimental reagent 2
Name: gentamicin sulfate injection
Batch number: 210907
Specification: 1 ml/piece, 10 pieces/box
The components: the main component is gentamicin sulfate
Action and use: aminoglycoside antibiotics for gram-negative and gram-positive bacterial infections
Production unit: shanghai Quanyu Biotechnology (Limb shop) animal pharmaceutical Co., Ltd
2.5 test strains
2.5.1 Experimental Strain 1
Name: staphylococcus aureus FSCC223001
Numbering: ATCC25923
The source is as follows: guangdong food safety strain preservation center
The category: class III
2.5.2 Experimental Strain 2
Name: candida albicans FSCC129001
Numbering: ATCC10231
The source is as follows: guangdong food safety strain preservation center
The category: class III
2.5.3 Experimental Strain 3
The name is as follows: escherichia coli FSCC149004
Numbering: ATCC8739
The source is as follows: guangdong food safety strain preservation center
The category: class III
2.6 test apparatus
2.6.1 Standard McLeod turbidimetric tube
The manufacturer: hedebeckmann biotechnology limited, lot No.: 20200728, expiration date: 12 months old
2.6.2 blood plate
The manufacturer: guangdong Huaqiao Biotech limited, production lot number: L2101Y, expiration date to: 2022.02.23
2.6.3 Potato dextrose agar
The manufacturer: guangdong Huaqiao Biotech limited, production lot number: 1105601, effective period to: 2024.08.18
2.6.4 nutrient agar
The manufacturer: guangdong Huaqiao Biotech limited, production lot number: 1086511, effective period to: 2022.11.05
2.6.5 TU-1810 type ultraviolet-visible spectrophotometer
The manufacturer: beijing Pujingyo general instruments, Limited liability company, number 092
2.6.6 SHH-150J type mould incubator
The manufacturer: yongsheng laboratory instruments of Chongqing City, number 120
2.6.7 SHH-150L type biochemical incubator, the manufacturer: yongsheng laboratory instruments of Chongqing City, serial number 118
3. Experimental system
3.1 Experimental animals
Variety/strain: new Zealand Rabbit
Grade: common stage
Sex: female
Number of purchased animals: number of animals used 20: 18 pieces of
Weight range at purchase: 1.8-2.2kg actual body weight range: 2.0-2.5kg
Supply unit: taiping, Hunan Biotech Ltd
Production license number of experimental animal: SCXK (Xiang) 2018-
License number for experimental animals: SYXK 2020 + 0004
3.2 reason for animal selection
The animal is recommended to be used in the technical guidelines on the research of drug irritation, anaphylaxis and hemolysis and the toxicology of drugs.
3.3 animal acceptance and quarantine
The experimental animals were received and quarantined as per the company SOP regulations, with a quarantine period of 6 days.
3.3.1 animals receive:
receiving time: 12 months and 08 days 2021
The experimental animals were weighed for receiving using an electronic balance model TP-5200 (No. 067).
3.3.2 animal quarantine:
and (3) quarantine time: 08 days 12/2021-13 days 12/2021
And (3) quarantine places: common environment C area laboratory III
During quarantine, the animal shape, fur, body shape, body temperature, movement, respiration, mouth and nose, excrement, genitals, urine, food intake and the like are observed and recorded by quarantine personnel every day, and if the animal is abnormal or weak and possibly influences the test, the animal is rejected and cannot be used in the test. After the quarantine was completed, the experimental animals were weighed using a TP-5200 electronic balance (No. 067). Animal quality is qualified through veterinarian inspection.
3.4 identification method of animal quarantine period
Animals were numbered and labeled during quarantine according to SOP regulations. When the animals enter the room, the sex is divided into a general number from 1. The inner side of the left ear is used for directly writing animal numbers for marking, and meanwhile, a corresponding white cage card is hung on the cage.
3.5 animal husbandry management
Experimental animals were kept under management according to company SOP.
3.5.1 animal rearing Environment
Raising a room: common environment C area laboratory III
Environmental grade: common stage
Temperature: 16-26 deg.C
Relative humidity: 40-70%
And (3) ventilation frequency: the animal illumination is more than or equal to 8 times/h: 100-200Lx
Illumination time: alternate illumination of 12h/12h every day
Animal cage utensil: the cage has a specification of 500mm × 315mm × 320mm, is made of stainless steel, and is produced by Suzhou von Willebrand laboratory animal facilities, Inc.
Feeding density: 1 per cage.
Cleaning and disinfecting: in the test period, a ground table is cleaned and disinfected once a day; cleaning and disinfecting the whole room once every week, and cleaning and disinfecting the ceiling once every month; taking down and cleaning food boxes and drinking articles (including drinking bottles and bottle stoppers) every week, draining water and returning; cleaning and disinfecting the cage once a week; cleaning the toilet pan once a day. The disinfectant is 84 disinfectant and benzalkonium bromide, and is used alternately for 7 days.
3.5.2 feed
Rabbit maintenance feed purchased from Szechwan feed company Limited (production permit number: SCXK 2020-: double-layer plastic; specification: each bag is 25 kg.
The feeding method comprises the following steps: according to company SOP specifications. The feed is fed twice a day, once in the morning and afternoon.
And (3) confirming the feed quality: nutritional ingredients, heavy metals, pesticide residues, microorganism indexes and the like in the feed are detected by referring to national standards GB/T14924.2-2001 and GB/T14924.3-2010 of the people's republic of China, and a supplier entrusts a third-party detection mechanism to detect once every quarter.
3.5.3 Drinking Water
The types are as follows: pure water, prepared by a company's pure water plant (No. 051).
The water supply method comprises the following steps: the water is freely drunk.
And (3) confirmation of water quality: according to national standards GB5750-2006, GB8538-2016, GB5749-2006 and GB14925-2010 of the people's republic of China, the microorganism indexes are detected by a genetic toxicology laboratory of the company for 1 time every 3 months, and the sensory indexes, the physicochemical indexes, the microorganism indexes and the like of water quality of units meeting corresponding quality of national regulations are sent to be detected once every year.
3.5.4 treatment of remaining animals
The remaining animals were euthanized according to company SOP requirements.
3.5.5 ethics and protection of animals
The experimental protocol is implemented after being reviewed and approved by the ethical committee of the company laboratory animal welfare and is executed according to the relevant national laboratory animal welfare regulations and the specification of the company SOP.
4 test method
4.1 dose setting (as in Table 1)
TABLE 1 dosage form
4.2 test methods
4.2.1 vaginal decontamination of New Zealand rabbits
The gentamicin sulfate injection and the metronidazole injection are mixed in equal volume, then 1mL of mixed solution is given to the vagina of each animal once a day for three consecutive days, so that the cleanness of the vagina of the animal is ensured, and the interference of original mixed bacteria of the vagina to the experiment is avoided.
4.2.2 preparation of Mixed bacterial liquid
Respectively inoculating Staphylococcus aureus, Escherichia coli and Candida albicans into blood plate, common nutrient agar and potato agar culture medium, culturing at 37 deg.C for 24 hr, culturing Candida albicans at 25 deg.C for 48 hr, respectively selecting appropriate amount of colony with sterile inoculating loop, placing into 10ml sterile physiological saline tube, continuously adjusting colony addition amount until the concentration of the colony is identical to that of Bickmann organism No. 5 standard tube by naked eye comparison, respectively sucking 1.5ml bacterial liquid, and detecting absorbance at 625nm wavelength with TU-1810 type ultraviolet visible spectrophotometer to ensure that OD value is in the range of 0.80-1.00 (i.e. bacterial liquid concentration of each bacterium is 1.5 × 109Bacteria/ml), adding the same amount of colony into each test tube, mixing, and measuring absorbance value within 2.40-3.00 (bacterial liquid concentration is 4.5 × 10)9Bacteria/ml).
Respectively sucking the concentrated solution at 4.5X 109Mixing bacteria/ml Staphylococcus aureus, Escherichia coli and Candida albicans 5ml into sterile test tube, and mixing to obtain mixed bacteria solution with total volume of 15ml and concentration of 4.5 × 109Bacteria/ml.
4.2.3 construction of New Zealand Rabbit vaginal bacterial infection model
Selecting 20 new zealand rabbits qualified for quarantine, female, and 3 new zealand rabbits as blank control groups, performing no treatment, inoculating the mixed bacteria solution into another 17 new rabbits, inserting a No. 16 rat gavage needle into the vagina for about 6cm, and repeatedly pushing the needle against the vaginal wall for 5-6 times, front, back, left and right, so as to cause slight local injury to the vaginal mucosa; injecting the mixed bacteria liquid into the vagina of a New Zealand rabbit by wrapping a latex tube outside a needle head, inoculating 1.0mL of each needle head, blocking the vagina with sterile absorbent cotton after inoculation, 1 time every day for 3 days continuously, smearing the materials in the vagina of all animals by adopting a sterile cotton swab in the 4 th day, then respectively transferring the obtained materials into a sterile tube containing 5mL of PBS for uniform mixing, diluting each sample for 2 gradients, respectively inoculating the sample into selective culture media of three strains, culturing for 24-72 hours at 37 ℃, and indicating that the molding is successful if staphylococcus aureus, escherichia coli and candida albicans appear on the culture media.
4.2.4 grouping and administering to subjects
Selecting 15 New Zealand rabbits which are successfully molded, and randomly dividing the rabbits into 5 groups according to the weight, a model control group, a gynecological gel 1 group, a gynecological gel 2 group, a gynecological gel 3 group and a clotrimazole group. Another 3 unmolded New Zealand rabbits were designated as blank control group, and there were 6 groups in total. Except for the blank control group, each group was given 1 mL/one of the corresponding test substances (gel matrix in the model control group), and the clotrimazole cream group was given 1.0 g/one of the clotrimazole cream 1 time per day for 5 consecutive days.
4.3 detection index
4.3.1 weight weighing
New Zealand rabbits were weighed before, at week 1 and at week 2 of the test.
4.3.2 vaginal introitus and surrounding tissue Observation
Before giving the test object, at the 1 st week and at the 2 nd week of giving the test object, swelling, congestion, secretion and the like of the vaginal orifice and surrounding tissues of the New Zealand rabbit are visually observed and graded, and the grading standard is as follows: no edema, no congestion, no secretion scored as 0; mild edema, hyperemia, visible secretion score 1; moderate edema, congestion, increased secretions scored 2 points; severe congestion, edema, and large secretions were scored 3 points with a maximum score of 3 points, as shown in Table 2.
TABLE 2 visual evaluation of New Zealand Rabbit vaginal orifice
4.3.3 anatomical visualization of vaginal tissue
After the New Zealand rabbits are euthanized by carbon dioxide, the vaginal tissues are taken out and immediately dissected to carry out visual observation on the inner walls of the vagina and grade, wherein the grade standard is as follows: no edema, no congestion, no erosion are scored as 0; mild edema, hyperemia, erosion score 1; moderate edema, congestion, erosion are scored as 2 points; severe congestion, edema, and erosion were scored as 3 points with a maximum score of 3 points, as shown in Table 3.
TABLE 3 visual evaluation of the tissue of the vaginal wall of New Zealand rabbits
4.3.4 examination of vaginal histopathology
After the dissection of a New Zealand rabbit, the vaginal tissue is fixed in 10% neutral formalin, and is subjected to conventional dehydration, embedding, slicing and staining for histopathological examination. Scoring was performed according to the histopathological scoring criteria shown in table 3, and the evaluation scores for each group of animals were added and divided by the number of observed animals and scored as the mean score for the group, with a maximum score of 16. As in table 4.
TABLE 4 vaginal histopathological examination score criteria
5 results of the test
5.1 Effect of different Specifications of gynecological gels on vaginal bacterial infection of New Zealand Rabbit body weight
Compared with a blank control group, the weight average of the model control group, the gynecological gel 1 group, the gynecological gel 2 group, the gynecological gel 3 group and the clotrimazole cream group before the test object is given, 1 week after the test object is given and 2 weeks after the test object is given has no statistical difference (P is more than 0.05). Compared with the model control group, the weights of the gynecological gel 1 group, the gynecological gel 2 group, the gynecological gel 3 group and the clotrimazole cream group are not statistically different before the test object is given, 1 week after the test object is given and 2 weeks after the test object is given (P is more than 0.05). The specific results are detailed in table 5.
TABLE 5 Effect of different gynecological gels on vaginal bacterial infection of New Zealand Rabbit weight: (
n＝3)
5.2 Effect of gynecological gels of different specifications on vaginal bacterial infection of New Zealand rabbit vaginal orifice inflammation
Compared with the blank control group, the model control group has obviously increased vaginal inflammation score (P is less than 0.05) before the test object is given, 1 week after the test object is given and 2 weeks after the test object is given. Compared with a model control group, the scores of all groups before the test substances are given have no statistical difference; the scores of the gynecological gel 1 group and the gynecological gel 2 group for the vaginal orifice inflammation after the test object is given for 1 week have no statistical difference, and the scores are obviously reduced after the test object is given for 2 weeks (P is less than 0.05); the scores of the vaginal inflammation of the patient in the gynecological gel group 3 and the clotrimazole cream group 1 week and 2 weeks after the patient is given are obviously reduced (P is less than 0.05). Compared with the clotrimazole cream group, no obvious difference is seen in the gynecological gel 1 group, the gynecological gel 2 group and the gynecological gel 3 group before the test object is given, 1 week after the test object is given and 2 weeks after the test object is given (P is more than 0.05), and the results are shown in a table 6.
TABLE 6 influence of gynecological gels of different specifications on vaginal bacterial infection of New Zealand Rabbit vaginal orifice inflammation
n＝3)
Note: compared with the blank control group, the composition of the composition,*P＜0.05，**p is less than 0.01. Compared with the model control group,△P＜0.05，△△p is less than 0.01. In comparison with the clotrimazole cream group,#P＜0.05，##P＜0.01。
5.3 Effect of gynecological gels of different specifications on vaginal bacterial infection of New Zealand rabbit vaginal tissue
Compared with the blank control group, the vagina inflammation score of the model control group is obviously increased after the dissection (P is less than 0.05). No significant difference was found in the vaginal inflammation scores of the animals in each group compared to the model control group (P >0.05), and the results are shown in Table 7.
TABLE 7 Effect of different gynecological gels on vaginal bacterial infection of New Zealand Rabbit vaginal tissue: (
n＝3)
Note: compared with the blank control group, the composition of the composition,*P＜0.05，**p is less than 0.01. Compared with the model control group,△P＜0.05，△△p is less than 0.01. In comparison with the clotrimazole group,#P＜0.05，##P＜0.01。
5.4 Effect of gynecological gels of different specifications on vaginal bacterial infection of New Zealand Rabbit vaginal histopathological morphology
Blank control group: the vaginal mucosa epithelium of the animal of the blank control group No. 1F02 can be seen to be degenerated, the mucosa lamina propria has little leukocyte infiltration, and the score is 2; no. 1F01 or No. 1F03 animal vaginal mucosal epithelial cells have no degeneration and necrosis, and mucosal lamina propria and submucosa have no pathological changes such as edema, hyperemia, hemorrhage, inflammatory cell infiltration, etc., and the score is 0. See table 8 for details.
Model control group: the model control group of animals No. 2F01 had local erosion of vaginal mucosa epithelium, small amount of leukocyte infiltration of mucosa lamina propria, and the score was 5; the vaginal mucosa tissue of the animal No. 2F02 is deformed, the inherent layer of the mucosa is heavily infiltrated by white blood cells, the blood vessels are slightly hyperemic, and the score is 7; no. 2F03 animal vaginal mucosal epithelial cells did not show degeneration and necrosis, and mucosal lamina propria and submucosa did not show pathological changes such as edema, hyperemia, hemorrhage, inflammatory cell infiltration, etc., and the score is 0. See table 8 for details.
Gynecological gel 1 group: the gynecological gel 1 group of No. 3F01 animals have visible cell degeneration of vaginal mucosa epithelium, mild leukocyte infiltration of mucosa lamina propria, and the score is 3; the epithelial cells of the vaginal mucosa of the animal No. 3F02 are denatured, the inherent layer of the mucosa is slightly infiltrated by white cells, the blood vessels are extremely congested, and the score is 4; no. 3F03 animal vaginal mucosal epithelial cells have no degeneration and necrosis, and mucosal lamina propria and submucosa have no pathological changes such as edema, hyperemia, hemorrhage, and inflammatory cell infiltration, and the score is 0. See table 8 for details.
Gynecological gel 2 group: the gynecological gel 2 group of animals No. 4F01 have degeneration of vaginal mucosa epithelial cells, little infiltration of leucocytes in mucosa lamina propria, little congestion of blood vessels and little edema, and the score is 4; the epithelial cells of the vaginal mucosa of the animal No. 4F02 are denatured, the inherent layer of the mucosa has little leukocyte infiltration, the blood vessels are slightly hyperemic, and the score is 4; no. 4F03 animal vaginal mucosal epithelial cells have no degeneration and necrosis, and mucosal lamina propria and submucosa have no pathological changes such as edema, hyperemia, hemorrhage, and inflammatory cell infiltration, and the score is 0. See table 6 for details.
Gynecological gel 3 groups: the gynecological gel 3 group of animals No. 5F01 have vaginal mucosal epithelial tissue deformation and the score is 2; the animal No. 5F02 has local erosion of vaginal mucosa epithelium, little leukocyte infiltration of mucosa lamina propria, little congestion of blood vessel, little edema, and score of 6; no. 5F03 animal vaginal mucosal epithelial cells have no degeneration and necrosis, and mucosal lamina propria and submucosa have no pathological changes such as edema, hyperemia, hemorrhage, and inflammatory cell infiltration, and the score is 0. See table 8 for details.
Clotrimazole cream group: the vaginal mucosa epithelial cells of animals No. 6F01 and No. 6F02 of the clotrimazole cream group have no degeneration necrosis, and the mucous membrane lamina propria and the mucous membrane lamina have no pathological changes such as edema, hyperemia, hemorrhage, inflammatory cell infiltration and the like, and the scores are 0 point; animal No. 6F03 has denatured vaginal mucosal epithelial cells, little leukocyte infiltration of mucosa lamina propria, little blood vessel congestion, and a score of 3. See table 8 for details.
TABLE 8 microscopic observation and scoring table
Compared with a blank control group, the number of the pathological changes of the model control group is large, the degree of the occurring pathological changes is serious, the score is high, and the statistical difference is realized (P is less than 0.05); compared with the model control group, the vaginal tissue lesions of the gynecological gel 1 group, the gynecological gel 2 group and the gynecological gel 3 group are improved in different degrees, the pathological scores are reduced, but no statistical difference is seen; the clotrimazole cream group has obviously improved vaginal tissue lesions, obviously reduced pathological scores and statistical difference (P is less than 0.05). See table 9 and figure 1 for details.
TABLE 9 vaginal histopathomorphology score (
n＝3)
Note: compared with the blank control group, the composition of the composition,*P＜0.05，**p is less than 0.01. Compared with the control group of the model,△P＜0.05，△△p is less than 0.01. In comparison with the clotrimazole cream group,#P＜0.05，##P＜0.01。
6 experiment summary
Under the test condition, the gynecological gels 1, 2 and 3 have no obvious influence on the weight average of the New Zealand rabbit bodies; the gynecological gels 1, 2 and 3 and the clotrimazole cream group have obvious improvement effect on the vaginitis of New Zealand rabbits caused by staphylococcus aureus, candida albicans and escherichia coli.
In vitro experiments
The gynecological gels 1, 2 and 3 are respectively subjected to bacteriostatic tests of candida albicans, staphylococcus aureus and escherichia coli, and the specific test contents are as follows:
candida albicans bacteriostasis test
1. Equipment
(1) Sample preparation: gynecological gel sample one (lot number 20210413).
(2) Candida albicans ATCC10231 (supplied by Kyork Microbiology technologies, Inc., Guangdong): collecting 24h fresh slant culture (generation 5), washing thallus Porphyrae with PBS, diluting with PBS to desired concentration, dripping 20 μ L onto sterilized cloth (1.0cm × 1.0cm), oven drying to recover thallus count of 1 × 104CFU/sheet-9X 104CFU/sheet.
(3) Sabouraud medium (batch No. 1103001).
(4) The instrument comprises the following steps: a biological safety cabinet (EC 18-01); biochemical incubator (EB 29-01); two-hole constant temperature water bath (EB 09-04).
2. Method of producing a composite material
(1) The detection basis is as follows: GB 15979 supplement 2002 hygienic Standard for Disposable sanitary articles appendix C.
(2) Detecting the environment: the temperature is 22.0-22.7 ℃, and the relative humidity is 53-58%.
(3) The detection method comprises the following steps:
placing the sample and the control matrix in a sterilization plate, taking the prepared carrier to respectively soak the sample and the matrix, respectively acting for 2min, 5min, 10min and 20min, taking out the carrier by using sterile forceps, respectively transferring the carrier into a test tube containing 5.0mL PBS for uniformly mixing, properly diluting, and respectively sucking 1.0mL of the plate to count the viable bacteria colonies. The experiment was repeated 3 times.
Second, Staphylococcus aureus bacteriostasis test
1. Equipment
(1) Sample preparation: gynecological gel sample I (batch number 20210413)
(2) Staphylococcus aureus ATCC 6538 (supplied by Kyork, Guangdong, Microbiol. technologies Co., Ltd.) bacterial vector: collecting 24h fresh slant culture (generation 5), washing thallus Porphyrae with PBS, diluting with PBS to desired concentration, dropping 20 μ L onto sterilized cloth (1.0cm × 1.0cm) carrier, oven drying to recover bacteria number of 1 × 104CFU/sheet-9X 104CFU/sheet.
(3) Nutrient agar medium (batch No. 1103581).
(4) The instrument comprises the following steps: a biological safety cabinet (EC 18-01); biochemical incubator (EB 29-01); two-hole constant temperature water bath (EB 09-04).
2. Method of producing a composite material
(1) The detection basis is as follows: GB 15979 supplement 2002 hygienic Standard for Disposable sanitary articles appendix C.
(2) Detecting the environment: the temperature is 22.0-22.7 deg.C, and the relative humidity is 53-58%.
(3) The detection method comprises the following steps:
placing the sample and the control matrix in a sterilization plate, respectively soaking the prepared carrier in the sample and the matrix, respectively acting for 2min, 5min, 10min and 20min, respectively, taking out the carrier by using sterile forceps, respectively transferring into a test tube containing 5.0mL PBS, mixing uniformly, diluting properly, and respectively sucking 1.0mL of tilting dish to count viable bacteria colonies. The experiment was repeated 3 times.
Coli bacteria inhibition test
1. Equipment
(1) Sample preparation: gynecological gel sample one (lot number 20210413).
(2) Coli 8099 (provided by Kyork, Guangdong, Microscience, Inc.) bacterial vector: collecting fresh slant culture (generation 5) cultured for 24 hr, washing thallus Porphyrae with PBS, diluting with PBS to desired concentration, dropping 20 μ L onto sterilized cloth (1.0cm × 1.0cm) carrier, oven drying to recover bacteria number of 1 × 104CFU/sheet-9X 104CFU/sheet.
(3) Nutrient agar medium (batch No. 1103581).
(4) The instrument comprises the following steps: a biological safety cabinet (EC 18-01); biochemical incubator (EB 29-01); two-hole constant temperature water bath (EB 09-04).
2. Method of producing a composite material
(1) The detection basis is as follows: GB 25979 appendix C of 2002 sanitary Standard for Disposable sanitary articles.
(2) Detecting the environment: the temperature is 22.0-22.7 ℃, and the relative humidity is 53-58%.
(3) The detection method comprises the following steps:
placing the sample and the control matrix in a sterilization plate, respectively soaking the prepared carrier in the sample and the matrix, respectively acting for 2min, 5min, 10min and 20min, respectively, taking out the carrier by using sterile forceps, respectively transferring into a test tube containing 5.0mL PBS, mixing uniformly, diluting properly, and respectively sucking 1.0mL of tilting dish to count viable bacteria colonies. The experiment was repeated 3 times.
Analysis of bacteriostatic Effect
1. Bacteriostatic effect of Candida albicans
The test was repeated 3 times at 20 ℃. + -. 1 ℃ with the inhibition (%) of the first sample at different times shown in Table 1, the inhibition (%) of the second sample at different times shown in Table 2, and the inhibition (%) of the third sample at different times shown in Table 3.
TABLE 1
Note: negative control: the colonies grow aseptically. As can be seen from Table 1, the average bacteriostasis rates of the samples on Candida albicans are 100.00% after the samples are acted for 2min, 5min, 10min and 20 min.
TABLE 2
Note: negative control: the colonies grow aseptically.
As can be seen from Table 2, the average inhibition rates of the samples on Candida albicans in the second action time of 2min, 5min, 10min and 20min are 96.45%, 100.00% and 100.00%, respectively.
TABLE 3
Note: negative control: the colonies grew aseptically.
As can be seen from Table 3, the average bacteriostasis rates of the samples on Candida albicans are 100.00% for 2min, 5min, 10min and 20 min.
2. Bacteriostatic effect of staphylococcus aureus
The test was repeated 3 times at 20 ℃. + -. 1 ℃ with the inhibition (%) for the first sample at different times shown in Table 4, the inhibition (%) for the second sample at different times shown in Table 5, and the inhibition (%) for the third sample at different times shown in Table 6.
TABLE 4
Note: negative control: the colonies grow aseptically.
As can be seen from Table 4, the average inhibitory rates of Staphylococcus aureus at 2min, 5min, 10min and 20min of the first action of the sample were 92.52%, 97.40%, 99.46% and 100.00%, respectively.
TABLE 5
Note: negative control: the colonies grew aseptically.
As can be seen from Table 5, the average inhibitory rates of the samples on Staphylococcus aureus after the second action for 2min, 5min, 10min and 20min are 89.60%, 94.40%, 99.41% and 100.00%, respectively.
TABLE 6
Note: negative control: the colonies grow aseptically.
As can be seen from Table 6, the average bacteriostatic rates of the samples on Staphylococcus aureus after three actions for 2min, 5min, 10min and 20min are 97.15%, 99.31%, 100.00% and 100.00%, respectively.
3. Bacteriostatic effect of Escherichia coli
The test was repeated 3 times at 20 ℃. + -. 1 ℃ with the inhibition (%) for the first sample at different times shown in Table 7, the inhibition (%) for the second sample at different times shown in Table 8, and the inhibition (%) for the third sample at different times shown in Table 9.
TABLE 7
As can be seen from Table 7, the average inhibition rates of the samples on Escherichia coli for 2min, 5min, 10min and 20min were 95.62%, 98.56%, 100.00% and 100.00%, respectively.
TABLE 8
As can be seen from Table 8, the average inhibition rates of the samples on Escherichia coli for 2min, 5min, 10min and 20min were 93.49%, 97.83%, 100.00% and 100.00%, respectively.
TABLE 9
Note: negative control: the colonies grew aseptically.
As can be seen from Table 9, the average inhibition rates of the samples on Escherichia coli for three actions of 2min, 5min, 10min and 20min were 99.23%, 100.00% and 100.00%, respectively.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (3)
1. The gynecological gel is characterized by being prepared from the following raw materials in parts by weight:
1-20 parts of polygonatum polysaccharide, 1-20 parts of pachymaran, 94010-20 parts of carbomer, 30-100 parts of aloe gel, 150-250 parts of glycerol, 0.1-10 parts of cinnamon volatile oil, 0.1-10 parts of houttuynia volatile oil, 0.1-10 parts of clove volatile oil, 10-20 parts of L-menthol, 10-20 parts of lactobacillus rhamnosus, 0.1-10 parts of ethylparaben, 20-80 parts of 95% ethanol and 150-250 parts of water.
2. A process for the preparation of a gynaecological gel according to claim 1, characterised in that it comprises in particular the following steps:
(1) weighing the raw materials according to the parts by weight of the raw materials as defined in claim 1, and adding water into the polygonatum polysaccharide and the pachyman to dissolve the raw materials completely for later use;
(2) solution A: adding carbomer 940 and aloe gel into the liquid dissolved in the step (1), uniformly stirring, standing for 6-24 hours, and fully swelling for later use;
(3) and B, liquid B: dissolving L-menthol, cinnamon volatile oil, houttuynia volatile oil, clove volatile oil and ethylparaben in 95% ethanol, adding glycerol, and stirring;
(4) and adding the solution B into the solution A for a few times, adding lactobacillus rhamnosus while stirring, homogenizing for 1-3 times by using a colloid mill after uniformly stirring, and filling to obtain the gynecological gel.
3. Use of a gynaecological gel according to claim 1 or a gynaecological gel prepared according to the method of claim 2 in the field of medicine.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101579432A (en) * | 2008-05-15 | 2009-11-18 | 北京法玛赛科医药科技有限公司 | Vaginal gel for treating gynecologic diseases, and preparation method thereof |
| CN106267329A (en) * | 2016-08-15 | 2017-01-04 | 湖南仁馨生物技术有限公司 | A kind of plants essential oil gel dressing and its preparation method and application |
| CN112316017A (en) * | 2020-11-19 | 2021-02-05 | 陕西康乐实业有限公司 | Gynecological antibacterial gel and preparation method thereof |
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| CN101579432A (en) * | 2008-05-15 | 2009-11-18 | 北京法玛赛科医药科技有限公司 | Vaginal gel for treating gynecologic diseases, and preparation method thereof |
| CN106267329A (en) * | 2016-08-15 | 2017-01-04 | 湖南仁馨生物技术有限公司 | A kind of plants essential oil gel dressing and its preparation method and application |
| CN112316017A (en) * | 2020-11-19 | 2021-02-05 | 陕西康乐实业有限公司 | Gynecological antibacterial gel and preparation method thereof |
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