CN118077903B - Oral probiotic composite preparation for improving vagina tightening and moisturizing environment for females and preparation method and application thereof - Google Patents
Oral probiotic composite preparation for improving vagina tightening and moisturizing environment for females and preparation method and application thereof Download PDFInfo
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Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L19/00—Products from fruits or vegetables; Preparation or treatment thereof
- A23L19/01—Instant products; Powders; Flakes; Granules
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/17—Amino acids, peptides or proteins
- A23L33/18—Peptides; Protein hydrolysates
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Nutrition Science (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Mycology (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The invention discloses an oral probiotic composite preparation for improving vagina tightening and moisturizing environment for females, and a preparation method and application thereof, wherein the oral probiotic composite preparation comprises the following components in parts by weight: 0.015-0.035 parts of lactobacillus rhamnosus, 0.015-0.035 parts of lactobacillus reuteri, 0.05-0.1 parts of sodium hyaluronate, 1.2-1.8 parts of collagen peptide and 0.3-0.4 parts of blueberry fruit powder; the number of active bacteria of the lactobacillus rhamnosus and the lactobacillus reuteri is 300-500 hundred million CFU/g respectively. Also comprises lactobacillus acidophilus 0.015-0.035 parts and lactobacillus crispatus 0.015-0.035 parts; the active bacteria number of the lactobacillus acidophilus and the lactobacillus crispatus is 300-500 hundred million CFU/g respectively. The oral probiotic composite preparation has remarkable effects on improving vagina tightening and moisturizing environment for females, does not influence normal beneficial flora in the vagina and produce side effects, and lays a foundation for development and application of novel oral microecologics in the future.
Description
Technical Field
The invention relates to the technical field of health-care product processing, in particular to an oral probiotic composite preparation for improving vagina tightening and moisturizing environment for females, and a preparation method and application thereof.
Background
Investigation by the World Health Organization (WHO) showed that over 90% of adult females had reproductive health problems; over 85.6% of divorces are due to incoordination between couples' lives; over 85% of adult women suffer from vaginitis; more than 70% of women suffer from cervical erosion to varying degrees; 87% of women suffer from more than one gynecological disease; vaginal relaxation occurs in 99% of women after delivery and the sexual desire is low; 95% of women with age have reduced genital tract function, and have premature senility, insomnia, anxiety and frigidity. More seriously, the health problems are repeated, have high morbidity and low cure rate, have certain potential hidden dangers and have great negative influence on the physiology and the psychology of females.
Among the main causes of vaginal relaxation are the following:
1. Breaking the elastic fiber to break the vaginal elastic fiber net;
2. pregnancy and labor cause tears in the muscles and fascia of the pelvic floor and the associated supporting ligaments become loose.
3. The progressive estrogen level of age drops, causing the muscles, fascia, ligaments and associated supporting structures to undergo degenerative changes, the tension of the muscles drops, the fascia becomes thinner, and the vaginal mucosa assumes atrophy, which increasingly aggravates the relaxation of the vagina.
4. Postmenopausal women have reduced estrogen levels, and the vaginal walls shrink, lose elasticity, and relax the vagina due to decline or even disappearance of ovarian function.
In addition, in addition to the above-mentioned vaginal relaxation phenomenon, vaginal dryness and dryness also affect reproductive health.
Disclosure of Invention
The invention aims to solve the technical problem of providing an oral probiotic composite preparation for improving vagina tightening and moisturizing environment for females, and a preparation method and application thereof.
In order to solve the technical problems, the invention adopts the following technical scheme:
In a first aspect, the invention provides an oral probiotic composite formulation for women to improve vaginal tightness and a moist environment, comprising, in parts by weight: 0.015-0.035 parts of lactobacillus rhamnosus, 0.015-0.035 parts of lactobacillus reuteri, 0.05-0.1 parts of sodium hyaluronate, 1.2-1.8 parts of collagen peptide and 0.3-0.4 parts of blueberry fruit powder; the number of active bacteria of the lactobacillus rhamnosus and the lactobacillus reuteri is 300-500 hundred million CFU/g respectively.
Lactobacillus rhamnosus and lactobacillus reuteri are separated from the urethra and the vagina of a healthy female respectively, and can smoothly pass through the gastrointestinal tract after being orally taken, and finally, the lactobacillus reuteri is planted in the vagina. Lactobacillus rhamnosus: and bacterioids (effectively killing other gram-negative bacteria such as escherichia coli, gardnerella vaginalis and the like and effectively killing yeasts) are generated. Lactobacillus reuteri: hydrogen peroxide (H 2O2) was produced effectively killing gram positive bacteria. The combination of the two can synergistically improve the colpitis, thereby improving the vaginal relaxation sense and the dry environment. The synergy of the two is shown in:
(1) Competing for nutrition: the combination of the two and pathogenic bacteria compete with the nutrition of vaginal secretion, and the growth of pathogenic bacteria is limited.
(2) Competition space: the two are combined, planted and guided to compete with the disease curing bacteria for survival space, and become dominant bacteria.
(3) Organic acid is generated: the combination of the two can generate organic acid to maintain the pH value of vagina below 4.5.
(4) Producing an antibacterial substance: the combination of the two can produce bacteriocin and hydrogen peroxide, and inhibit the growth of pathogenic bacteria.
Sodium hyaluronate can promote the generation of collagen and elastic fiber, thereby improving skin elasticity. It stimulates skin cells to produce new collagen and elastic fibers and promotes their distribution and alignment within the skin. Particularly, a layer of moisturizing film is formed on the surface of the mucous membrane layer, so that moisture is effectively locked, and the local moisture content is increased.
The repeated unit of the amino acid sequence of the collagen peptide is the same as the specific functional region of the amino acid sequence of human collagen, and the collagen peptide has good tissue compatibility, high safety and low sensitization. The collagen peptide obviously enhances the vaginal tensile capacity, thickens the vaginal lamina propria and the muscular layer, increases the blood vessel and the collagen fiber quantity in connective tissue of the lamina propria, promotes the expression of extracellular matrix components and promotes the early adhesion of sacral ligament fibroblasts. The device is matched with massage daily or the instrument helps the collagen to absorb, so that the device can effectively supplement the collagen, is beneficial to repairing damaged tissues at the pelvic floor, strengthens the elasticity and toughness of connective tissues at the pelvic floor, recovers the elasticity of the vulva skin, promotes the repair of mucous membranes, and further improves the vaginal relaxation.
As a further improvement of the invention, the invention comprises the following components in parts by weight: lactobacillus rhamnosus 0.025 parts, lactobacillus reuteri 0.025 parts, sodium hyaluronate 0.08 parts, collagen peptide 1.5 parts and blueberry fruit powder 0.37 parts, wherein the active bacteria numbers of the lactobacillus rhamnosus and the lactobacillus reuteri are 400 hundred million CFU/g respectively.
Further, the method comprises the following steps of: 0.015-0.035 parts of Lactobacillus acidophilus and 0.015-0.035 parts of Lactobacillus crispatus; the active bacteria number of the lactobacillus acidophilus and the lactobacillus crispatus is 300-500 hundred million CFU/g respectively.
Lactobacillus acidophilus can improve female health in a variety of ways. First, lactobacillus acidophilus can inhibit the proliferation of candida albicans in the vagina. Candida albicans is a common pathogen of vaginal infection, and when the number of the candida albicans is excessive, vaginitis and other related diseases are caused. While lactobacillus acidophilus is capable of producing a substance called lactic acid, which makes the vaginal environment acidic, thereby inhibiting the proliferation of candida albicans. Second, lactobacillus acidophilus also enhances the vaginal mucosal barrier function. The vaginal mucosal barrier is the first line of defense against the entry of harmful microorganisms into the vagina, and when its function is impaired, it can lead to the occurrence of various female diseases. And lactobacillus acidophilus can prevent harmful microorganisms from entering the vagina by enhancing the barrier function of the vaginal mucosa, thereby maintaining the health of women. In addition, lactobacillus acidophilus can also promote the immunomodulatory effects in the vagina. Vaginal immunomodulation is one of the important mechanisms to prevent the invasion of harmful microorganisms, which, when impaired in function, can lead to the occurrence of a variety of female diseases. And lactobacillus acidophilus can prevent harmful microorganisms from entering the vagina by promoting the immunoregulation in the vagina, thereby maintaining the health of women.
Lactobacillus crispatus, which has been the first line of defense of the female genitourinary tract as demonstrated by studies in recent decades, colonized the human vagina, is the most common beneficial bacterium among the vaginal flora of healthy humans, and produces large amounts of lactic acid which are powerful broad-spectrum bactericides, virucides and immunomodulators that can be used as prebiotics and probiotics for restoring the vaginal flora.
Lactobacillus crispatus growth metabolism produces acid which inhibits the growth of pathogenic bacteria associated with urogenital infections. It has been shown that acidic substances produced by Lactobacillus crispatus in anaerobic conditions inhibit the growth of N.gonorrhoeae. Lactobacillus crispatus has a strong hydrogen peroxide-producing ability, second only to lactobacillus jensenii. Meanwhile, 21 strains of lactobacillus crispatus are separated from vaginal secretion of pregnant women in China, wherein 90.48 percent of the lactobacillus crispatus can generate hydrogen peroxide, the hydrogen peroxide generating capacity of the strains is divided into 4 grades from strong to no, and the proportions of the lactobacillus crispatus and the lactobacillus crispatus are 19.05 percent, 52.38 percent, 19.05 percent and 9.52 percent in sequence. In addition, lactobacillus crispatus has an inhibitory effect on the growth of Staphylococcus epidermidis and Streptococcus angina.
The lactobacillus rhamnosus, lactobacillus reuteri, lactobacillus acidophilus and lactobacillus crispatus are all probiotics, and the action mechanism is as follows:
(1) Biological antagonism: under the condition that the normal vaginal microbiota is normal in type and quantity, the normal vaginal microbiota has obvious antagonism to external bacteria or pathogenic bacteria, and the vaginal microbiota is protected from being affected and infected.
(2) Stimulating the activity of vaginal mucosal cells: the health state and normal secretion function of the vaginal mucosa are maintained, and the effect of sexual behavior is improved.
(3) Promoting the growth and development of female reproductive system: the female reproductive system, including the labia, clitoris, vagina, posterior forum, cervix, endometrium, fallopian tube and ovary, all of which are closely related to the normal microbiota of the vagina in terms of growth and development or other functions, because in the case of dysbacteriosis the entire reproductive system will have organic and functional changes.
(4) Self-cleaning action: the vaginal flora has the effect of decomposing putrefying substances and old waste. Abnormal secretions such as leucorrhea, menstrual residues, lochia, fishy smell and the like can be removed by the self-cleaning effect of normal vaginal flora.
(5) Immunomodulation: the normal microbiota of human body mainly comprises intestinal tract, respiratory tract, oral cavity, skin and vagina, and has immunoregulatory effect, so that human body cell immunity and humoral immunity can be kept in balance state, and human body 'self-stabilizing mechanism' (homoestas i s) can be operated normally.
Further, the method comprises the following steps of: lactobacillus rhamnosus 0.025 parts, lactobacillus reuteri 0.025 parts, lactobacillus acidophilus 0.025 parts, lactobacillus crispatus 0.025 parts, sodium hyaluronate 0.08 parts, collagen peptide 1.5 parts and blueberry fruit powder 0.32 parts, wherein the active bacteria numbers of the lactobacillus rhamnosus, the lactobacillus reuteri, the lactobacillus acidophilus and the lactobacillus crispatus are 400 hundred million CFU/g respectively.
Further, the collagen peptide is derived from mollusc, fish or land animal, and comprises one or more of abalone, sea cucumber, snail, clam, razor clam, fish, sheep, cow and pig.
In a second aspect, the present invention provides a method of preparing an oral probiotic composite formulation for use in improving vaginal tightness and a moist environment in a female, comprising the steps of:
(1) Sieving the raw materials to obtain fine powder for later use;
(2) Weighing: respectively weighing raw materials according to the formula proportion;
(3) Mixing: uniformly mixing all the lactobacillus in the raw materials to obtain first mixed powder; dissolving collagen peptide into collagen peptide aqueous solution by using purified water, mixing sodium hyaluronate and blueberry fruit powder to obtain second mixed powder, preparing soft materials or not soft materials by using the collagen peptide aqueous solution and the second mixed powder, granulating or not granulating, drying, finishing or not finishing, crushing or not crushing, and then mixing with the first mixed powder to obtain total mixed particles.
Further, the method further comprises the following steps:
(4) And (3) inner packaging: bagging the total mixed particles, wherein the loading amount is controlled to be 1.9-2.1g.
In a third aspect, the invention also provides an application of the oral probiotic composite preparation or the oral probiotic composite preparation prepared by the preparation method in preparing an oral probiotic composite preparation for improving vaginal tightening of women and/or an application in preparing an oral probiotic composite preparation for improving vaginal moisturizing environment of women.
The probiotics composite preparation provided by the invention has remarkable effects on improving the vaginal tightening and moisturizing environment of females, and meanwhile, normal beneficial flora in the vagina and side effects are not influenced, so that a foundation is laid for the development and application of novel oral microecologics in the future.
Drawings
The foregoing is merely an overview of the present invention, and the present invention is further described in detail below with reference to the accompanying drawings and detailed description.
FIG. 1 is a diagram showing a production process (preparation method) of an oral probiotic composite preparation according to an embodiment of the present invention;
FIG. 2 is a graph of clinical data statistics in an embodiment of the present invention;
FIG. 3 is a graph of Nugent scoring results in an embodiment of the invention;
FIG. 4 is a graph of vaginal pressure test results in an embodiment of the invention;
Fig. 5 is a graph showing the results of evaluation of vaginal dryness in an embodiment of the present invention.
Detailed Description
Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
In the process of researching and developing probiotics and improving vaginal flora balance, the inventor unexpectedly finds that the probiotics product taking lactobacillus rhamnosus and lactobacillus reuteri as the combination can improve the phenomenon of vaginal tightening and moisturizing environment in part of crowd experiments, so that the product formula is re-matched with the combination bacteria as a main component, the product quality standard and the production process are formulated, crowd comparison tests are developed, and some detection indexes of the product are formulated.
The invention provides an oral probiotic composite preparation for improving vagina tightening and moisturizing environment for females, which at least comprises the following raw materials: 2 or 4 of lactobacillus rhamnosus, lactobacillus reuteri, lactobacillus acidophilus and lactobacillus crispatus, and the nutritional ingredients are sodium hyaluronate, collagen peptide and blueberry fruit powder.
The following is a detailed description of the embodiments.
Example 1
1. Formula compatibility 1:
2 g/bag, 1 bag in the morning and evening, each bag is prepared as follows:
2. The formula is compatible with 2:
2 g/bag, 1 bag in the morning and evening, each bag is prepared as follows:
The compatibility of the above formula is prepared according to the following production process (preparation method) by matching with the formula shown in figure 1:
1. Taking lactobacillus rhamnosus, lactobacillus reuteri, lactobacillus acidophilus, lactobacillus crispatus, sodium hyaluronate, collagen peptide and blueberry fruit powder which meet the qualification of inspection;
2. Removing the outer package from each raw material, and enabling the inner package to enter a clean area through a buffer window;
3. Sieving: sieving lactobacillus rhamnosus, lactobacillus reuteri, lactobacillus acidophilus, lactobacillus crispatus, sodium hyaluronate, collagen peptide and blueberry fruit powder with 80 mesh sieve to obtain fine powder for use;
4. weighing: weighing lactobacillus rhamnosus, lactobacillus reuteri, sodium hyaluronate, collagen peptide and blueberry fruit powder according to a formula proportion;
5. Mixing: mixing lactobacillus rhamnosus, lactobacillus reuteri, lactobacillus acidophilus and lactobacillus crispatus for 15min, and uniformly mixing to obtain first mixed powder; dissolving collagen peptide into collagen peptide aqueous solution by using purified water, mixing sodium hyaluronate and blueberry fruit powder to obtain second mixed powder, preparing soft materials (or not preparing soft materials) by using the collagen peptide aqueous solution and the second mixed powder, granulating (or not granulating), drying, finishing (or not finishing), not crushing (or crushing), and then mixing with the mixed powder 1 to obtain total mixed particles. Wherein, if the powder is crushed, the powder is in a granular state if the powder is not crushed. The final product has two standard characters, namely powder or granule.
6. And (3) inner packaging: the total mixed particles were bagged, 2 g/bag. The packaging process is controlled to be different in loading quantity, the allowable positive and negative deviation is 5%, the inspection is carried out every 15min, the loading quantity is controlled to be 1.9-2.1g, and the semi-finished product is obtained, and the total quantity of active bacteria of at least the composite probiotics in each bag of preparation is 20 hundred million CFU. The standard of the composite film for medicine packaging for inner packaging accords with the rule of YBB00132002 composite film for medicine packaging and general rule of bags.
7. And (3) external packing: 14 bags/boxes, and are packaged by corrugated paper.
8. Checking and warehousing
And (5) checking the finished products item by item according to each quality index specified by the product, and stamping and warehousing after the finished products are qualified.
Remarks description: workshop conditions meet the GMP requirement, and the air cleanliness of the clean area reaches 10 ten thousand levels.
EXAMPLE 2 technical parameter testing
The technical specification/requirement has an important influence on the quality of the product, can ensure that the product meets the standard requirement, improves the reliability and stability of the product, can also improve the competitiveness and market acceptance of the product, and promotes the upgrading and innovation development of industry.
The quality of the product is controlled from the sensory requirements, the efficacy components, the physicochemical indexes, the microorganism and the net content of the planned specification, wherein the indexes of the related national standard requirements of heavy metals (lead, arsenic and mercury) and the negative deviation be strict with of the net content can better ensure the safety and the efficacy of the product.
1. Sensory requirements
Sensory requirements should be met in Table 1
Table 1 sensory requirements
2. Functional component
The effective components meet the requirements of Table 2
TABLE 2 functional ingredients
| Project | Index (I) |
| Lactic acid bacteria, CFU/100g is more than or equal to | 5.0×109 |
3. Physical and chemical index
The physical and chemical indexes meet the requirements of Table 3
TABLE 3 physicochemical index
| Project | Index (I) |
| Moisture content is less than or equal to | 5.0 |
| Ash content is less than or equal to | 9.0 |
| Lead (Pb)/mg/kg is less than or equal to | 2.0 |
| Total arsenic (As)/mg/kg is less than or equal to | 1.0 |
| Total mercury (Hg)/mg/kg is less than or equal to | 0.3 |
4. Microorganism index
The microorganism index should meet the specifications of Table 4
TABLE 4 microbial indicators
| Project | Index (I) |
| Coliform bacteria, MPN/g is less than or equal to | 0.92 |
| Mould and yeast, CFU/g is less than or equal to | 50 |
| Staphylococcus aureus | 0/25g |
| Salmonella bacteria | 0/25g |
5. Net content and allowable negative bias
The net content and the allowable negative deviation should be in accordance with the specifications of Table 5
TABLE 5 net content and allowable negative bias
EXAMPLE 3 stability Studies
The long-term stability test is carried out by referring to the health food stability test guidelines, and the product can keep the shelf life for 18 months under the sealed, shady and dry condition through test data analysis, and the effective component probiotics (lactobacillus) of the product do not reach obvious attenuation. The following test results of the long-term stability test are shown in tables 6 to 12 below, taking formula 1 in example 1 as an example:
Table 6 results of month zero
TABLE 7 results of month 3
TABLE 8 results of month 6
TABLE 9 results of month 9
Table 10 results of month 12
TABLE 11 results of month 15
Table 12 18 th month results
Stability test results evaluation: through three batches of sample stability tests, the sensory, efficacy component, physicochemical index and net content of the product (granule) are comprehensively examined, the repeatability of each index detection method is good, the fluctuation of each index detection value of the product is small, the quality requirement can be met, and the product stability in the effective period is ensured. The above is a product using granules, and similarly, powder products can also ensure stability during the period of validity.
Example 4 crowd function verification
Crowd verification-women with different degrees such as vaginal relaxation, dryness and the like are study objects, the ages are 25-45 years, menstrual cycle is regular, menstrual period is normal, and women with normal regular life in non-gestation period and lactation period are provided; setting medicine administration or suppository control group.
465 Gynaecological and obstetrical outpatients are randomly selected, and sexual females aged 22-45 are divided into 5 groups, an experimental group (a probiotics group A/B, a compound group A/B) and a control group, 93 groups are taken by the control group, the product prepared by the embodiment 1 of the invention is taken by the experimental group. The main clinical situations are: symptoms such as congestion and edema, itching, vaginal mucosa elasticity decrease, vaginal atrophy, vaginal relaxation, vaginal environment dryness and the like caused by vaginal inflammation infection.
Experimental group: probiotic group a (probiotics in formula 1), probiotic group B (part of probiotics in formula 2), compound group a (formula 1), compound group B (formula 2), specifically as follows:
Probiotic group a (probiotics in formula 1): lactobacillus rhamnosus, lactobacillus reuteri; the rest is supplemented by maltodextrin;
probiotic group B (part of probiotics in formula 2): lactobacillus acidophilus and Lactobacillus crispatus; the rest is supplemented by maltodextrin;
compound group a (formula compatibility 1): lactobacillus rhamnosus, lactobacillus reuteri, sodium hyaluronate, collagen peptide, blueberry fruit powder;
compound group B (formula compatibility 2): lactobacillus rhamnosus, lactobacillus reuteri, lactobacillus acidophilus, lactobacillus crispatus, sodium hyaluronate, collagen peptide, blueberry fruit powder;
1. the treatment method comprises the following steps:
1 bag (2 g/bag) of the product is taken daily, 1 piece of ornidazole dispersible tablet (0.25 g/tablet) is taken daily, 1 treatment course is taken after 14 days of mild treatment, and 1 treatment course is taken after 30 days of moderate and severe treatment.
2. Standard of efficacy:
(1) And (3) healing: the symptoms disappear, the erosion surface disappears, the secretion disappears, the cervical is smooth, the vagina is compact and the environment is moist.
(2) The method is effective: the symptom is obviously improved, the erosion surface is reduced by more than 50%, the severity is changed into moderate, the moderate is changed into mild, and the vagina tightening and moisturizing environment are improved;
(3) Invalidation: the symptoms and the surface erosion are not obviously improved.
Nugent score:
Nugent scoring is that 30 visual field observation count lactobacillus, gram-negative bacillus (gardnerella vaginalis), gram-negative bacillus (bacteroides), gram-negative campylobacter (campylobacter) and integrated value are taken under an oil lens of a sample of vaginal secretion of a gram-dyed volunteer, nugent scoring is calculated by summation, scoring value is 0-3 and is defined as normal, and 4-6 are defined as transition state; it is more than or equal to 7 BV, namely bacterial vaginosis. Wherein the Nugent scoring system is as follows in table 13:
TABLE 13Nugent scoring Table
4. Vaginal pressure test:
the vaginal relaxation was tested using a vaginal manometer.
(1) Opening a pressure switch, extruding the air bag, adjusting the pressure at a 20N position, and then screwing the switch;
(2) Adding a proper amount of lubricating liquid, sterilizing with alcohol, and placing the measuring head into vagina;
(3) During measurement, the user needs to stand and differentiate the two legs, the user does not need to record the shoulder width, and the user can forcefully contract the pessary muscle and the pelvic floor muscle at the same time, and measurement data on the instrument are recorded;
(4) Relaxing, breathing, measuring for the second time, measuring for three times, and taking an average value to obtain a vaginal relaxation standard value;
(5) Taking out the measuring head after measurement, washing with clear water, sterilizing with alcohol, and placing into a package.
Table 14 vaginal pressure test comparative table
5. The treatment effect is as follows:
(1) The statistical results of the clinical data are shown in table 15 and fig. 2:
Table 15 clinical data statistics
(2) Nugent scoring results are shown in Table 16 and FIG. 3:
Table 16Nugent scoring Table
(3) The vaginal pressure test results are shown in Table 17 and FIG. 4:
table 17 vaginal pressure test meter
(4) The subjective evaluation results of vaginal wetting are shown in table 18 and fig. 5;
Table 18 subjective evaluation chart of vaginal wetting
(5) From the data, the total effective rate of the experimental group (the compound group A and the compound group B) can reach 97.8 percent and 95.7 percent respectively, and the total effective rate of the control group is only 75.3 percent; in Nugent scoring projects after taking, the improvement effective rate of the experimental groups (compound groups A and B) can reach 96% and 95.7% respectively, and the improvement effective rate is equivalent to that of a medicine control group; in the vaginal pressure test data, in a very loose vaginal state, the effective rate of the experimental groups (the compound groups A and B) can reach 76.5 percent and 72.4 percent respectively, and meanwhile, the vaginal relaxation of 48.8 percent and 48.4 percent of people in the experimental groups is recovered to normal condition; the subjective evaluation data of vaginal wetting show that the total effective rate of the experimental groups (compound groups A and B) can reach 63.4% and 58.1% respectively, and the vaginal dryness phenomenon can be effectively improved.
The probiotics product prepared by the invention not only has good adhesiveness in the vagina, but also can stabilize and permanently sterilize, diminish inflammation and relieve itching, improve the vaginal wettability, improve vaginal atrophy, relieve external drying pain symptoms and restore the balance efficacy of vaginal flora.
The above description is only of the preferred embodiments of the present invention, and is not intended to limit the invention in any way, and some simple modifications, equivalent variations or modifications can be made by those skilled in the art using the teachings disclosed herein, which fall within the scope of the present invention.
Claims (9)
1. An oral probiotic composite preparation for improving vagina tightening and moisturizing environment for women is characterized by comprising the following components in parts by weight: 0.015-0.035 parts of lactobacillus rhamnosus, 0.015-0.035 parts of lactobacillus reuteri, 0.05-0.1 parts of sodium hyaluronate, 1.2-1.8 parts of collagen peptide and 0.3-0.4 parts of blueberry fruit powder;
The number of active bacteria of the lactobacillus rhamnosus and the lactobacillus reuteri is 300-500 hundred million CFU/g respectively.
2. The oral probiotic composite formulation for women to improve vaginal tightening and moisturizing environment according to claim 1, characterized by comprising, in parts by weight: lactobacillus rhamnosus 0.025 parts, lactobacillus reuteri 0.025 parts, sodium hyaluronate 0.08 parts, collagen peptide 1.5 parts and blueberry fruit powder 0.37 parts, wherein the active bacteria numbers of the lactobacillus rhamnosus and the lactobacillus reuteri are 400 hundred million CFU/g respectively.
3. The oral probiotic composite formulation for women to improve vaginal tightness and moist environment according to claim 1, characterized in that it further comprises, in parts by weight: 0.015-0.035 parts of Lactobacillus acidophilus and 0.015-0.035 parts of Lactobacillus crispatus; the active bacteria number of the lactobacillus acidophilus and the lactobacillus crispatus is 300-500 hundred million CFU/g respectively.
4. An oral probiotic composite formulation for women to improve vaginal tightness and moist environment according to claim 3, characterized in that it comprises, in parts by weight: lactobacillus rhamnosus 0.025 parts, lactobacillus reuteri 0.025 parts, lactobacillus acidophilus 0.025 parts, lactobacillus crispatus 0.025 parts, sodium hyaluronate 0.08 parts, collagen peptide 1.5 parts and blueberry fruit powder 0.32 parts, wherein the active bacteria numbers of the lactobacillus rhamnosus, the lactobacillus reuteri, the lactobacillus acidophilus and the lactobacillus crispatus are 400 hundred million CFU/g respectively.
5. The oral probiotic composite formulation for women to improve vaginal tightness and moist environment according to any of claims 1-4, characterized in that the collagen peptide is derived from one or more of abalone, sea cucumber, snail, clam, razor clam, fish, sheep, cow, pig.
6. A method of preparing an oral probiotic composite formulation for use in women to improve vaginal tightness and moist environment according to any of claims 1-5, characterized in that it comprises the steps of:
(1) Sieving the raw materials to obtain fine powder for later use;
(2) Weighing: respectively weighing raw materials according to the formula proportion;
(3) Mixing: uniformly mixing all the lactobacillus in the raw materials to obtain first mixed powder; dissolving collagen peptide into collagen peptide aqueous solution by using purified water, mixing sodium hyaluronate and blueberry fruit powder to obtain second mixed powder, preparing soft materials or not soft materials by using the collagen peptide aqueous solution and the second mixed powder, granulating or not granulating, drying, finishing or not finishing, crushing or not crushing, and then mixing with the first mixed powder to obtain total mixed particles.
7. The method of preparing an oral probiotic composite formulation for use in improving vaginal tightness and moist environment in women according to claim 6, further comprising:
(4) And (3) inner packaging: bagging the total mixed particles, wherein the loading amount is controlled to be 1.9-2.1g.
8. Use of an oral probiotic composite formulation according to any one of claims 1 to 5, for the preparation of an oral probiotic composite formulation for improving vaginal tightness and a moist environment in women.
9. Use of an oral probiotic composite formulation prepared by the method of any one of claims 6 to 7, for the preparation of an oral probiotic composite formulation for improving vaginal tightness and a moist environment in women.
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