CN111228458A

CN111228458A - External biological preparation for preventing and treating colpitis and preparation method thereof

Info

Publication number: CN111228458A
Application number: CN202010210954.0A
Authority: CN
Inventors: 李伟; 佟长青; 李姹姹
Original assignee: Dalian Fullerene Pharmaceutical Co Ltd
Current assignee: Dalian Fullerene Pharmaceutical Co Ltd
Priority date: 2020-03-24
Filing date: 2020-03-24
Publication date: 2020-06-05

Abstract

The invention discloses an external biological preparation for preventing and treating colpitis, which can maintain an acidic environment with the pH value of vagina being less than or equal to 4.5, has stronger buffering capacity and sterilization effect and no irritation, and is prepared from the following raw materials in percentage by mass: 1-5% of sophora flavescens extract, 1-5% of poria cocos extract, 0.1-2% of angelica sinensis extract, 0.1-2% of wild chrysanthemum flower extract, 0.1-2% of white lily flower extract, 0.1-2% of hamamelis virginiana extract, 0.1-2% of calendula extract, 1-10% of 1, 3-butanediol, 0.1-2% of hydroxyethyl cellulose, 0.1-2% of ammonium acryloyl dimethyl taurate/VP copolymer, 0.1-2% of disodium ethylene diamine tetraacetate, 0.1-10% of antibacterial peptide and the balance of water.

Description

External biological preparation for preventing and treating colpitis and preparation method thereof

Technical Field

The invention relates to a medicine for preventing and treating female genital tract inflammation, in particular to an external biological preparation which can maintain the acidic environment of vaginal pH less than or equal to 4.5, has stronger buffering capacity and sterilization effect and has no stimulation and can prevent and treat vaginal inflammation and a preparation method thereof.

Background

Female Reproductive Tract Infection (RTI) is mainly an infectious disease occurring in the female Reproductive system and is a disease caused by various pathogenic microorganisms such as parasites, viruses, bacteria, fungi, chlamydia and the like. The normal female genital tract flora mainly takes gram-positive lactobacillus as a dominant bacterium, and the lactobacillus decomposes glycogen in vaginal mucosa epithelium under an acidic environment to generate lactic acid and simultaneously generates hydrogen peroxide and lactein, so that the breeding and propagation of pathogenic bacteria can be effectively inhibited. Researches show that the maintenance of the pH value of the vagina is less than or equal to 4.5, and the balance of the microbial flora structure of the vagina is an important factor for maintaining the health of the female reproductive tract.

At present, gel for treating colpitis is available, namely, a medicament for treating pathogenic bacteria is prepared by mixing blank gel, and the gel has good adhesion and retention. The existing gel contains three kinds of medicines, namely antibiotics, traditional Chinese medicine extracts or antibacterial peptides. The antibiotic has the best antibacterial effect, but has the problem of destroying the self-cleaning function of the vagina and causing the imbalance of normal flora in the vagina; the traditional Chinese medicine extract also has good curative effect, but the pH value of the traditional Chinese medicine extract is about 7.5, so that the traditional Chinese medicine extract not only can influence the growth of dominant bacteria such as gram-positive lactobacillus and the like and has certain influence on the self-cleaning function of the vagina, but also can stimulate the skin and sometimes generate side effects such as skin redness and swelling and the like; the pH value of the antibacterial peptide is about 3.8, which is beneficial to self-cleaning of vagina, but the antibacterial effect is relatively weak.

Disclosure of Invention

In order to solve the technical problems in the prior art, the invention provides an external biological preparation for preventing and treating colpitis, which can maintain the acidic environment of the pH value of the vagina to be less than or equal to 4.5, has strong buffering capacity and sterilization effect and is non-irritant, and a preparation method thereof.

The technical solution of the invention is as follows: a biological preparation for external use for preventing and treating colpitis is prepared from the following raw materials in percentage by mass: 1-5% of sophora flavescens extract, 1-5% of poria cocos extract, 0.1-2% of angelica sinensis extract, 0.1-2% of wild chrysanthemum flower extract, 0.1-2% of white lily flower extract, 0.1-2% of hamamelis virginiana extract, 0.1-2% of calendula extract, 1-10% of 1, 3-butanediol, 0.1-2% of hydroxyethyl cellulose, 0.1-2% of ammonium acryloyl dimethyl taurate/VP copolymer, 0.1-2% of disodium ethylene diamine tetraacetate, 0.1-10% of antibacterial peptide and the balance of water.

The preparation method of the external biological preparation for preventing and treating the vaginitis is characterized by comprising the following steps of:

a. adding 1, 3-butanediol, hydroxyethyl cellulose, acryloyl dimethyl ammonium taurate/VP copolymer and water into a container, and uniformly stirring and dissolving; heating the container to 85 ℃, adding disodium ethylene diamine tetraacetate, and stirring at constant temperature for 30min to obtain blank gel;

b. cooling blank gel to 45 deg.C under stirring, adding radix Sophorae Flavescentis extract, Poria extract, radix Angelicae sinensis extract, flos Chrysanthemi Indici extract, flos Albizziae extract, Hamamelis virginiana extract, herba Sidae Rhombifoliae extract and antibacterial peptide, and stirring; and (4) carrying out ultraviolet irradiation for 30 min.

According to the invention, the traditional Chinese medicine extract, the antibacterial peptide and the gel raw materials are reasonably proportioned, the pH value is 3.8-4.4, the buffering capacity is strong, an acidic environment with the pH value of less than or equal to 4.5 in the vagina can be maintained, a good environment is created for the growth of dominant bacteria such as gram-positive lactobacillus and the like, the self-cleaning function of the vagina is improved, the effective components of the medicine are easily absorbed by skin mucosa and are not stimulated, the sterilization effect is improved, and the preparation method can be used for preventing and treating female genital tract inflammation.

Detailed Description

Example 1:

the invention relates to an external biological preparation for preventing and treating colpitis, which consists of the following raw materials in percentage by mass: 2.5% of sophora flavescens extract, 2.5% of poria cocos extract, 0.4% of angelica sinensis extract, 0.4% of wild chrysanthemum flower extract, 0.4% of lily flower extract, 0.4% of hamamelis virginiana extract, 0.4% of calendula extract, 6% of 1, 3-butanediol, 0.2% of hydroxyethyl cellulose, 0.75% of acryloyl dimethyl ammonium taurate/VP copolymer, 0.3% of ethylene diamine tetraacetic acid disodium and 2.1% of antibacterial peptide (BioMAPAs), and the balance of water.

The preparation method comprises the following steps:

The raw materials used were derived as follows:

radix Sophorae Flavescentis extract, Poria extract, radix Angelicae sinensis extract, flos Chrysanthemi Indici extract, flos Albiziae extract, Hamamelis virginiana extract and herba Sidae Rhombifoliae extract, which are available from QINGSHUI scientific Co., Ltd in Beijing cloud; antimicrobial peptides (biomaps) were purchased from yogy biotechnology, guangzhou; 1, 3-butanediol is purchased from Beijing Chengzhilingyuan scientific and technological development company Limited; hydroxyethyl cellulose is available from Beijing, Seattle, commerce and trade, Inc.; acryloyldimethyl ammonium taurate/VP copolymer, disodium ethylenediaminetetraacetate was purchased from Shenyang permanent cleaning & cleaning materials, Inc.

Example 2:

the external biological preparation for preventing and treating the vaginitis consists of the following raw materials in percentage by mass: 1% of sophora flavescens extract, 5% of poria cocos extract, 0.1% of angelica sinensis extract, 2% of wild chrysanthemum flower extract, 0.1% of white lily flower extract, 2% of hamamelis virginiana extract, 0.1% of calendula extract, 2% of 1, 3-butanediol, 1% of hydroxyethyl cellulose, 1% of acryloyl dimethyl ammonium taurate/VP copolymer, 1% of disodium ethylene diamine tetraacetate, 10% of antibacterial peptide and the balance of water.

The preparation method and the raw material source are the same as those of the example 1.

Example 3:

the external biological preparation for preventing and treating the vaginitis consists of the following raw materials in percentage by mass: 5% of sophora flavescens extract, 1% of poria cocos extract, 2% of angelica sinensis extract, 0.1% of wild chrysanthemum flower extract, 2% of lily flower extract, 0.1% of hamamelis virginiana extract, 2% of calendula extract, 8% of 1, 3-butanediol, 2% of hydroxyethyl cellulose, 2% of acryloyl dimethyl taurate/VP copolymer, 2% of disodium ethylene diamine tetraacetate, 8% of antibacterial peptide and the balance of water.

Examples of the experiments

The pH value and the buffering capacity of the invention are measured

1. The external biological preparation for preventing and treating the vaginitis, which is obtained in the embodiment 1 of the invention, is placed in a thermostat with the temperature of 22 ℃, and the pH value is measured to be 4.13 when the relative humidity is 50%.

2. The external biological agent for preventing and treating the vaginitis of the embodiment 1 of the invention is dissolved in distilled water, 0.060mol and 0.070mol of strong acid and strong base are respectively added, the pH value is measured, the average value is obtained by measuring three times, and the measurement result is 4.13.

The invention has strong buffering capacity, can maintain the pH value of the vagina to be less than or equal to 4.5, and can prevent vaginitis.

The invention is used for clinical observation of vaginitis

1. Observation object

Based on the principle of volunteers, 500 cases were selected as the observation targets, and the observation targets were equally divided into example 1 group, blank gel group, control group 1, control group 2, and control group 3. According to the routine examination results of clinical symptoms, signs and leucorrhea, each group of patients is divided into 40 cases of nonspecific vaginitis (vaginal cleanliness III and degree IV), 25 cases of trichomonas vaginitis and 35 cases of mycotic vaginitis, the ages of the vaginitis are 25-49 years, and the patients are married, are not in menstrual period and are not in gestation period and are not treated by other medicines.

2. Symptoms and signs

Four kinds of vaginitis have different degrees of leucorrhea increase, vulvar pruritus or burning sensation. Gynecological examination: vaginal mucosa has different degrees of congestion and many vaginal secretions. Wherein the trichomonas vaginitis secretion is foam-like yellow green dilute solution. The secretion of the mycotic vaginitis is bean dregs or cheese. Nonspecific vaginitis secretions are purulent or bloody.

3. Method of treatment

The using method and the using amount of each group are the same, and the medicaments used in each group are as follows:

example 1 group: the external biological preparation for preventing and treating the vaginitis, which is obtained in the embodiment 1, is disclosed.

Blank gel group: the blank gel obtained in step 1 of the method of example 1 of the invention has a pH of 7.

Control group 1: the composite material is prepared by the method of the embodiment 1, and is different from the embodiment 1 in that the composite material is composed of the following raw materials in percentage by mass: 2.8 percent of lightyellow sophora root extract, 2.8 percent of Indian buead extract, 0.7 percent of Chinese angelica extract, 0.7 percent of wild chrysanthemum flower extract, 0.7 percent of white lily flower extract, 0.7 percent of Hamamelis virginiana extract, 0.7 percent of calendula extract, 6 percent of 1, 3-butanediol, 0.2 percent of hydroxyethyl cellulose, 0.75 percent of acryloyl dimethyl ammonium taurate/VP copolymer, 0.3 percent of ethylene diamine tetraacetic acid disodium, the balance of water and the pH value of 7.2.

Control group 2: the composite material is prepared by the method of the embodiment 1, and is different from the embodiment 1 in that the composite material is composed of the following raw materials in percentage by mass: 6% of 1, 3-butanediol, 0.2% of hydroxyethyl cellulose, 0.75% of acryloyl dimethyl taurate/VP copolymer, 0.3% of ethylene diamine tetraacetic acid disodium, 9.1% of antibacterial peptide (BioMAPAs), and the balance of water and the pH value is 3.5.

Control group 3: chitosan gynecological gel (purchased externally).

The vaginal medicine application method is adopted: taking supine position before sleep, bending knee, lightly inserting the medicine into deep vagina cervix with finger wearing finger stall, drawing out finger stall, and discarding. The medicine is taken once every night, 5-7 days are a treatment course, and 1-2 treatment courses are treated. Vaginal discharge was examined 2 days after withdrawal or after the next menstrual period was cleared. Recording the symptoms and signs before and after the administration, and routine examination results of leucorrhea in laboratory examination.

4. Therapeutic effects

And (3) curing: clinical symptoms and physical signs disappear, the vaginal secretion of the specific vaginitis is checked to be clean at the degree of I-II, and the pathogen turns negative through routine examination of leucorrhea. Improvement: clinical symptoms and signs disappear partially, the cleanness of vaginal secretion of specific vaginitis is checked to be I-II degrees, and pathogens are turned into negative through routine leucorrhea check. And (4) invalidation: clinical symptoms and physical signs are not changed, the vaginal secretion inspection cleanliness of the specific vaginitis is in the range of III-IV degrees, and pathogens are still positive in routine leucorrhea inspection.

5. The results were analyzed as in Table 1.

TABLE 1

Third, the invention biological preparation bacteriostasis experimental research

The control groups 1, 2 and 3 of the invention example 1 were treated with E.coli (Escherichia coli) 8099A. aureus (S.), (Staphylococcus aureus) ATCC 6538, Candida albicans (A. albicans)Candida albicans) ATCC 10231 was subjected to inhibition experiments and the results of viable bacteria are shown in Table 2.

The drugs used in controls 1, 2, and 3 were the same as in experiment 2.

TABLE 2

Fourth, the invention is to the vagina mucosa stimulating reaction experiment

Experimental animals: 6 rabbits, female rabbits, 1500-2000 g in weight, are divided into a group of the invention in the embodiment 1 and a control group, and are fed with complete pellet feed, and the feeding environment is as follows: the temperature is 23.1-25.5 ℃, the humidity is 45-59.4%, and the breeding is carried out in a single cage.

The experimental method comprises the following steps: the rabbit is fixed on the back, and the perineum and the vaginal opening are exposed. A catheter (a child having a length of about 8cm connected to a 5mL syringe) was wetted and gently inserted into the vagina (4 cm) and 2mL of the biological preparation of the present invention was slowly injected into the vagina with the syringe, and the catheter was withdrawn. Control animals were treated with saline in the same manner.

After 24h, the animals are killed by an air embolism method, the whole vagina is taken out after the abdominal incision, the longitudinal dissection is carried out, whether congestion, edema and other phenomena exist or not is observed by naked eyes, then the animals are placed into 10% formalin solution for fixation for 48h, tissues of all parts of the two ends and the middle part 3 of the vagina are selected for flaking, HE staining is carried out, and histopathology examination is carried out.

The result evaluation method comprises the following steps: the histopathological examination results were scored. The stimulation response integrals of 3 parts of the 3 rabbits in the experimental group are added and then divided by the total observation number (the number of the rabbits is multiplied by 3) to obtain the average integral of the vaginal mucosa stimulation response of the experimental group. The control scoring method was as above.

The experimental results are shown in table 3 below.

TABLE 3

Note: mean integral = sum of stimulation response integrals at 3 sites of 3 animals/total number of observations (number of animals x 3); stimulation index = mean integral of invention group-mean integral of control group.

The result shows that the external biological preparation for preventing and treating the vaginitis has the stimulation index of 0 to the vaginal mucosa of the rabbit, and the stimulation response intensity of the vaginal mucosa is the stimulation without the vaginal mucosa.

Claims

1. The external biological preparation for preventing and treating the vaginitis is characterized by comprising the following raw materials in percentage by mass: 1-5% of sophora flavescens extract, 1-5% of poria cocos extract, 0.1-2% of angelica sinensis extract, 0.1-2% of wild chrysanthemum flower extract, 0.1-2% of white lily flower extract, 0.1-2% of hamamelis virginiana extract, 0.1-2% of calendula extract, 1-10% of 1, 3-butanediol, 0.1-2% of hydroxyethyl cellulose, 0.1-2% of ammonium acryloyl dimethyl taurate/VP copolymer, 0.1-2% of disodium ethylene diamine tetraacetate, 0.1-10% of antibacterial peptide and the balance of water.

2. A method for preparing the biological preparation for external use for preventing and treating vaginal inflammation according to claim 1, comprising the steps of: