Probiotic-containing compositions and their application in regulating menstruation, improving dysmenorrhea, and vaginal health

Abstract

The present application belongs to the field of food technology, and relates to a composition containing probiotics and application thereof in regulating menstruation, improving dysmenorrhea and vaginal health. The composition contains cinnamon powder, red ginseng powder or red ginseng extract, and lactic acid bacteria compound powder NWH. The present application selects cinnamon and red ginseng, and scientifically compounds the lactic acid bacteria compound powder NWH with active ingredients of raw materials. The active ingredients of plant raw materials and the lactic acid bacteria compound powder NWH play a synergistic role, and have the effects of preventing or improving dysmenorrhea, preventing or improving infectious vaginitis, and improving PCOS. Through strict formula and process research, the raw materials in the composition are stable and compatible, the effect of the composition is fully exerted, and the problem that saponins and polyphenol flavonoids in red ginseng and cinnamon components inhibit the activity of probiotics is avoided. The composition of the present application is simple in composition, clear in proportion, and high in safety, and avoids the problems of complex components, unclear mechanism of action, and side effects.

Description

Technical Field

[0001] This invention belongs to the field of food technology and relates to probiotic-containing compositions and their application in regulating menstruation, improving dysmenorrhea, and vaginal health. Background Technology

[0002] Irregular sleep patterns and unbalanced diets can easily lead to a weakened immune system. A weakened immune system often causes various health problems, with menstrual irregularities and infectious vaginitis being the most common gynecological issues.

[0003] From the perspective of modern medicine, menstrual irregularities are often caused by endocrine disorders, specifically hormonal imbalances. Main symptoms include excessively short or long menstrual cycles, irregular periods, and dysmenorrhea. Polycystic ovary syndrome (PCOS) is another menstrual disorder caused by excessively high levels of androgens, leading to infrequent menstruation, dysmenorrhea, hirsutism, acanthosis nigricans, and other symptoms. It often results in infertility due to anovulation or infrequent ovulation. In most cases, PCOS is also accompanied by a series of metabolic diseases, such as metabolic syndrome, type 2 diabetes, and cardiovascular disease, all closely related to insulin resistance, severely impacting quality of life. Primary dysmenorrhea is a common painful symptom during menstruation. Current solutions primarily involve painkillers, which have drawbacks such as significant side effects, short-lasting effects, and only treating the symptoms, not the underlying cause. From the perspective of Traditional Chinese Medicine, primary dysmenorrhea is caused by qi and blood deficiency, kidney qi deficiency, and cold stagnation of blood. Currently, there are many traditional Chinese medicine preparations for improving menstrual cramps, all of which are composed of multiple herbs. These preparations are numerous and varied, and as with any medicine, there are always some side effects. Since everyone's tolerance to the side effects of different herbs varies, the use of multiple herbs in these preparations increases the risk of side effects.

[0004] Infectious vaginitis is a bacterial or fungal vaginitis caused by vaginal flora imbalance due to a weakened immune system in women, which can result without timely intervention. Currently, the common treatment for vaginitis is oral antibiotics. However, due to the emergence of new pathogens and drug resistance, antibiotic use has a high relapse rate and can easily lead to antibiotic-induced diarrhea caused by intestinal flora imbalance, resulting in poor patient compliance. With in-depth research on probiotics, their benefits in regulating vaginal flora and improving infectious vaginitis have been clinically recognized. Orally administered probiotics enter the digestive tract and eventually reach the terminal rectum, migrating through the perineum to the reproductive tract and colonizing, thereby inhibiting pathogenic bacteria and regulating flora balance. During this process, some also colonize the intestines, improving insulin resistance and hyperandrogenemia in PCOS patients by regulating intestinal microecological balance, improving the intestinal mucosal barrier, and downregulating inflammatory factors. However, not all probiotics possess these functions; even within the same species, there are significant differences in functional and stability characteristics. Therefore, the functional positioning of probiotics should be based on the strain number.

[0005] Chinese invention patent CN101332282A discloses a traditional Chinese medicine composition and its preparation method for treating gynecological diseases caused by kidney deficiency and coldness. This composition consists of raw materials including red ginseng, leek seed, dodder seed, fenugreek, amethyst, wormwood, cinnamon, morinda root, cornus fruit, cnidium fruit, epimedium, yangqi stone, cistanche, Sichuan pepper, and motherwort. It is used to treat gynecological diseases such as kidney deficiency and coldness, irregular menstruation, and dysmenorrhea. This invention's traditional Chinese medicine composition involves multiple herbs, has a complex composition, and a complex mechanism of action, potentially leading to side effects.

[0006] Chinese invention patent CN107998154A discloses a probiotic preparation for the prevention and treatment of women's diseases, its preparation method, and its application. The probiotic preparation comprises a powder component and a solution component. The powder component is prepared from the following raw materials in weight percentages: 1-13% probiotic compound powder, 2-10% tara gum, 35-55% fructooligosaccharides, and 35-55% galactooligosaccharides; the probiotic compound powder is composed of *Lactobacillus rhamnosus* R11, *Lactobacillus reuteri* HA188, and *Lactobacillus helveticus* R52. The solution component is prepared from the following raw materials in weight percentages: 1-25% fructooligosaccharides, 0.001%-0.01% citric acid, and the balance being physiological saline. This probiotic preparation can effectively regulate the health of the reproductive tract flora, alleviating and improving female reproductive tract infections such as bacterial vaginosis, fungal vaginitis, pelvic inflammatory disease, cervicitis, and urinary tract infections. This patented preparation is a combination of all probiotics, which is only for improving infectious vaginal inflammation. It does not address the improvement of dysmenorrhea or PCOS, nor does it have any conditioning effect on the body.

[0007] Chinese invention patent CN110179121A discloses a five-component probiotic composition for improving gut health. By weight, it comprises the following components: 60-65 parts isomaltosylate, 25-30 parts maltodextrin, 15-20 parts erythritol, 10-12 parts galactooligosaccharides, and 11-25 parts probiotics. The probiotics include *Lactobacillus rhamnosus* R0011, *Lactobacillus helveticus* R0052, *Lactobacillus rhamnosus* GG, *Bifidobacterium animalis* B94, and *Bifidobacterium longum* R0175. This invention also provides a compound solid beverage prepared according to the above five-component probiotic composition. Through a scientifically formulated ratio of strains, it promotes the absorption of effective amounts of live bacteria in the gastrointestinal tract, regulates the intestinal flora, and improves gastrointestinal discomfort symptoms, such as various gastrointestinal discomfort symptoms after bacterial infection-induced flora imbalance, and symptoms such as antibiotic-associated diarrhea. It also regulates the intestinal environment, thereby enhancing immunity and fundamentally regulating the immune response to allergic diseases. Furthermore, it improves the female body's constitution and effectively prevents and treats bacterial vaginosis. The composition in this patent has only been studied for the prevention and treatment of bacterial vaginosis, and its effects on dysmenorrhea and PCOS have not been studied. Summary of the Invention

[0008] In view of the existing technology, no solution has been found to simultaneously prevent or improve dysmenorrhea, PCOS and infectious vaginal inflammation, fill the technological gap, and existing compositions related to regulating women's menstrual health have complex drug compositions, unclear dose-effect relationships and technical problems such as side effects. The purpose of this invention is to provide a probiotic-containing composition and its application in regulating menstruation, improving dysmenorrhea and vaginal health.

[0009] To achieve the above objectives, the present invention adopts the following technical solution:

[0010] The present invention provides a composition comprising cinnamon powder and red ginseng powder or red ginseng extract.

[0011] Further, the composition contains, by weight, 0.1-10 parts cinnamon powder, 0.2-10 parts red ginseng powder, or 0.14-7.1 parts red ginseng extract.

[0012] Furthermore, the composition comprises, by weight, 1 part cinnamon powder, 5 parts red ginseng powder, or 3.6 parts red ginseng extract.

[0013] The present invention also provides a composition comprising cinnamon powder, red ginseng powder or red ginseng extract, and lactic acid bacteria compound powder NWH.

[0014] Furthermore, the lactic acid bacteria compound powder NWH is composed of Lactobacillus helveticus R0052, Lactobacillus rhamnosus R0011, and Lactobacillus reuteri HA188.

[0015] Further, the composition, by weight, contains 0.1-10 parts cinnamon powder, 0.2-10 parts red ginseng powder or 0.14-7.1 parts red ginseng extract, and 1-10 parts lactic acid bacteria compound powder NWH.

[0016] Furthermore, the composition, by weight, comprises 1 part cinnamon powder, 5 parts red ginseng powder or 3.6 parts red ginseng extract, and 3 parts lactic acid bacteria compound powder NWH.

[0017] Further, in the composition, the mass ratio of cinnamon powder, red ginseng powder and lactic acid bacteria compound powder NWH is 0.1-10:0.2-10:1-10, or the mass ratio of cinnamon powder, red ginseng extract and lactic acid bacteria compound powder NWH is 0.1-10:0.14-7.1:1-10.

[0018] Furthermore, in the composition, the mass ratio of cinnamon powder, red ginseng powder, and lactic acid bacteria compound powder NWH is 1:5:3, or the mass ratio of cinnamon powder, red ginseng extract, and lactic acid bacteria compound powder NWH is 1:3.6:3.

[0019] Furthermore, the composition also comprises at least one of the following ingredients: probiotics, plant extracts, prebiotics, soy lecithin, collagen, elastin peptides, resveratrol, nutritional yeast powder, red dates, longan, black beans, brown sugar, donkey-hide gelatin, goji berries, and dried tangerine peel.

[0020] Furthermore, the composition also comprises at least one of the following raw materials: Lactobacillus plantarum, Bifidobacterium animalis, Lactobacillus rhamnosus, Lactobacillus curvatureii, Lactobacillus casei, Lactobacillus paracasei, Lactobacillus helveticus, Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium longum, Lactobacillus reuteri, Lactobacillus salivarius, saffron extract, carob extract, cranberry extract, amla extract, grape seed extract, pomegranate extract, rose extract, soybean lecithin, collagen, elastin peptides, resveratrol, tremella polysaccharide, yeast β-glucan, nutritional yeast powder, red dates, longan, black beans, brown sugar, donkey-hide gelatin, wolfberry, and dried tangerine peel.

[0021] Furthermore, the composition further comprises fruit powder or juice, said fruit powder or juice being at least one of apple powder and / or juice, sweet orange powder and / or juice, peach powder and / or juice, passion fruit powder and / or juice, pear powder and / or juice, pomegranate powder and / or juice, lychee powder and / or juice, longan powder and / or juice, watermelon powder and / or juice, cantaloupe powder and / or juice, blueberry powder and / or juice, strawberry powder and / or juice, banana powder and / or juice, mangosteen powder and / or juice, kiwi fruit powder and / or juice, and star fruit powder and / or juice.

[0022] Furthermore, the composition also includes a sweetener, an acidity modifier, and a thickener.

[0023] Furthermore, the sweetener is at least one selected from sucrose, glucose, fructose, xylitol, lactitol, erythritol, sucralose, mogrosides, steviol glycosides, licorice extract, fructooligosaccharides, isomaltooligosaccharides, galactooligosaccharides, and inulin.

[0024] Furthermore, the acidity regulator is at least one of citric acid and malic acid.

[0025] Furthermore, the thickener is at least one selected from pectin, guar gum, xanthan gum, and sodium methylcellulose.

[0026] The present invention also provides a method for preparing the composition, comprising the following steps:

[0027] Weigh out the lactic acid bacteria compound powder NWH, cinnamon powder, and red ginseng powder or red ginseng extract according to the formula, mix them evenly, and the composition is obtained.

[0028] Furthermore, the method for preparing the cinnamon powder includes the following steps:

[0029] S1. Grind the dried cinnamon bark, sift it, and obtain coarse cinnamon powder;

[0030] S2. Add water to the cinnamon powder described in step S1, mix, and soak to obtain a mixture;

[0031] S3. Raise the temperature of the mixture described in step S2 to 75-85℃ and extract with ultrasonic assistance for 10-20 minutes to obtain the extract.

[0032] S4. Filter and concentrate the extract obtained in step S3 to obtain a concentrated solution;

[0033] S5. Add the concentrated solution from step S4 to resistant dextrin, and after drying, obtain cinnamon powder.

[0034] Furthermore, in step S2, the ratio of coarse cinnamon powder to water is 1:20 g / mL, and the soaking time is 20-40 min.

[0035] Furthermore, the resistant dextrin in step S5 has a mass fraction of 25%.

[0036] Furthermore, the drying described in step S5 is spray drying.

[0037] The present invention also provides the use of the composition in the preparation of products that improve dysmenorrhea, regulate menstrual cycles, and improve infectious vaginal inflammation.

[0038] The present invention also provides a product that improves dysmenorrhea, regulates the menstrual cycle, and improves infectious vaginal inflammation, comprising the aforementioned composition.

[0039] Furthermore, the dosage form of the product is direct-drinking powder, tablets, capsules, soft capsules, or oral liquid.

[0040] Cinnamon, the dried bark and branch bark of the cinnamon tree (Cinnamomum cassia), is a common spice and herb widely used in cooking and herbal remedies. In China, cinnamon is now included in the list of food and medicine homologous, serving both as a food ingredient and a traditional Chinese medicine. The effects of cinnamon on women's menstrual health are receiving increasing attention. According to the 2020 edition of the Pharmacopoeia, cinnamon has the effects of tonifying yang, dispelling cold and relieving pain, and warming the meridians, showing good effects in improving dysmenorrhea and dispelling uterine cold. The cinnamon powder of this invention is prepared through a specific process, and its active ingredient, double-chain cinnamon polyphenol type A polymer, is ≥3%, and coumarin is ≤0.7%.

[0041] Red ginseng, a perennial herb belonging to the genus Panax of the Araliaceae family, is a processed form of ginseng, obtained through washing, steaming, and other processing methods. Its extremely high medicinal value has been recognized since ancient times. It possesses the effects of greatly replenishing vital energy, restoring pulse and consolidating the body, and invigorating qi and stopping bleeding. In China, it is listed as a food and medicine homology ingredient, meaning it can be used both as a food ingredient and as a traditional Chinese medicine. Red ginseng plays an important role in regulating women's overall health, including menstrual health, skin health, and menopausal health. The key active ingredient in red ginseng, ginsenosides, has a structure similar to estrogen, giving it estrogen-like effects, thereby regulating sex hormone balance and playing an important role in regulating menstruation, alleviating premenstrual syndrome, and menopausal syndrome. The red ginseng used in this invention is red ginseng powder or red ginseng extract. Among them, red ginseng powder is obtained by sterilizing, drying and pulverizing red ginseng, with a total ginsenoside content of ≥1.6% and a moisture content of ≤7.0%; red ginseng extract is obtained by extracting red ginseng, sterilizing, concentrating and filtering it, with a soluble solids content of ≥60.0% and a total ginsenoside content of ≥3.0%.

[0042] NWH, a complex lactic acid bacteria powder, is composed of three strains: *Lactobacillus helveticus* R0052, *Lactobacillus rhamnosus* R0011, and *Lactobacillus reuteri* HA188, which were isolated and screened from dairy products and the human body, respectively. NWH has two main sites of action: the gut and the female reproductive tract. In the gut, it maintains the normal intestinal mucosal barrier, regulates immunity, modulates cytokine secretion, effectively improves inflammatory responses, and maintains a healthy gut. This, in turn, regulates hormone balance through the gut-brain axis, improving PCOS and its associated inflammatory responses. In the female reproductive tract, it lowers the pH of the reproductive tract, inhibits pathogenic bacteria colonization, and regulates the flora balance by producing H2O2 and lactic acid, effectively repairing and improving urinary tract or reproductive tract infections.

[0043] The beneficial effects of this invention are as follows:

[0044] This invention uses carefully selected cinnamon powder, red ginseng powder, or red ginseng extract as raw materials. Through the scientific compounding of lactic acid bacteria compound powder NWH with the raw materials, the plant raw material components and lactic acid bacteria compound powder NWH exert a synergistic effect, which can prevent or improve dysmenorrhea, prevent or improve infectious vaginal inflammation, and improve PCOS.

[0045] This invention, through rigorous formulation and process research, uses a specific process to prepare cinnamon powder, ensuring the stability and compatibility of the raw materials in the composition, guaranteeing the full realization of the composition's effects, and avoiding the problem of saponins and polyphenolic flavonoids in red ginseng and cinnamon inhibiting the activity of probiotics.

[0046] The composition of the present invention is simple, with a clear proportion and high safety, avoiding the problems of complex composition, unclear mechanism of action, and side effects. Attached Figure Description

[0047] Figure 1 The average menstrual cycle of each group before and after the intervention in Example 1 and the comparative intervention;

[0048] Figure 2 The average score of vaginal secretions in each group before and after intervention in Example 1 and the comparative example is given. Detailed Implementation

[0049] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0050] Before further describing specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terminology used in the embodiments of the present invention is for describing specific embodiments and not for limiting the scope of protection of the present invention.

[0051] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0052] Unless otherwise specified, all raw materials used in this invention are commercially available products commonly used in this technical field. The NWH lactic acid bacteria compound powder was purchased from Raman Group, with a live bacteria count of 30 billion CFU / gram.

[0053] Example

[0054] The formulations of the compositions in Examples 1-3 and Comparative Examples 1-5 are shown in Table 1.

[0055] Table 1

[0056]

[0057] The methods for preparing cinnamon powder in the compositions of Examples 1-3 and Comparative Examples 1-5 are as follows:

[0058] S1. Dry the dried cinnamon bark at 40℃, grind it into powder, and pass it through an 80-mesh sieve to obtain coarse cinnamon powder;

[0059] S2. Mix the obtained coarse cinnamon powder and pure water at a ratio of 1g:20mL, and soak at room temperature for 30 minutes to obtain a mixture;

[0060] S3. Then, the temperature of the mixture is raised to 80°C, and ultrasonic extraction is performed for 15 minutes to obtain the extract.

[0061] S4. After cooling the extract to room temperature, filter to remove impurities and concentrate to 20% of the original volume to obtain the concentrate.

[0062] S5. Add 25% by mass of resistant dextrin to the concentrate and spray dry to obtain cinnamon powder;

[0063] The spray dryer has an inlet air temperature of 150℃, an outlet air temperature of 75℃, and a rotation speed of 16000rpm.

[0064] The cinnamon powder obtained by the above preparation method contains ≥3% of the active ingredient double-chain cinnamon polyphenol type A polymer and ≤0.7% of coumarin.

[0065] Comparative Example 6

[0066] The difference between this comparative example and Example 1 lies in the preparation method of the cinnamon powder; specifically, the cinnamon powder is prepared by a heating and reflux alcohol extraction process, as detailed below:

[0067] S1. Dry the dried cinnamon bark at 40℃, grind it into powder, and pass it through an 80-mesh sieve to obtain coarse cinnamon powder;

[0068] S2. Mix the obtained coarse cinnamon powder and 80% ethanol at a ratio of 1g:20mL and soak at room temperature for 30 minutes to obtain a mixture;

[0069] S3. Then, the temperature of the mixture is raised to 80°C and refluxed twice, 2 hours each time, to obtain the extract;

[0070] S4. After cooling the extract to room temperature, filter to remove impurities and concentrate to 20% of the original volume to obtain the concentrate.

[0071] S5. Add 25% by mass of resistant dextrin to the concentrate and spray dry to obtain cinnamon powder;

[0072] The spray dryer has an inlet air temperature of 150℃, an outlet air temperature of 75℃, and a rotation speed of 16000rpm.

[0073] The cinnamon powder obtained by the above preparation method contains ≥1.5% of the active ingredient double-chain cinnamon polyphenol type A polymer and ≤2% of coumarin.

[0074] Performance test

[0075] I. Inhibitory ability against three common vaginal pathogens

[0076] Test subjects: Compositions of Examples 1-3 and Comparative Examples 1-6.

[0077] Take multiple test tubes and add modified Martin's medium, LST medium, and TSB medium. Inoculate activated Candida albicans, Escherichia coli, and Atobococcus vaginalis into the corresponding mediums, respectively. Then add the composition solutions from Examples 1-3 and Comparative Examples 1-6 to the test tubes, respectively, with final concentrations of 256 μg / mL, 128 μg / mL, 64 μg / mL, 32 μg / mL, 16 μg / mL, 8 μg / mL, 4 μg / mL, 2 μg / mL, and 1 μg / mL. Half-dilution concentrations of 0.5 μg / mL, 0.25 μg / mL, 0.125 μg / mL, and 0.0625 μg / mL were set and cultured at 37℃ and 5% CO2 for 24 hours. After the culture, the bacterial solution was streaked onto an agar plate using a sterile inoculation loop. The streaked plate was then incubated at 37℃ and 5% CO2 for 12 hours. The concentration at which no corresponding bacterial strain grew at the streaked area was determined as the minimum inhibitory concentration (MIC). The results are shown in Table 2.

[0078] Table 2. Minimum inhibitory concentrations (MICs) of three common vaginal pathogens.

[0079]

[0080] As shown in Table 2, the MIC of Example 1 against all three pathogenic bacteria was the lowest, indicating that the composition of Example 1 had the strongest inhibitory effect against Candida albicans, Escherichia coli and Atobococcus vaginalis. The other examples also showed good inhibitory effects against the three pathogenic bacteria.

[0081] The MICs of the three pathogenic bacteria in Comparative Examples 1-5 were higher than those in Example 1. This indicates that the combination of red ginseng powder, cinnamon powder, and lactic acid bacteria compound powder NWH in a certain proportion can synergistically inhibit the three pathogenic bacteria, thereby improving and preventing infectious vaginitis.

[0082] As can be seen from the results of Comparative Example 6, when the preparation method of cinnamon powder is changed, the MIC of the composition against the three pathogenic bacteria is significantly higher than that of Example 1, indicating that the cinnamon powder prepared by the specific process of this application exhibits significant antibacterial activity against the three vaginal pathogenic bacteria and can prevent the occurrence of vaginal inflammation.

[0083] II. Human Clinical Testing

[0084] Table 3 Composition of Test Sample Formulation

[0085]

[0086] 2.1 Experimental Methods

[0087] We are recruiting 200 women aged 20-40 who are troubled by gynecological problems. The screening criteria are as follows: 1. Meet the diagnostic criteria for polycystic ovary syndrome (PCOS): According to the Rotterdam criteria issued by the European Centre for Human Reproduction and Embryology and the American Society for Reproductive Medicine in 2003, and the Chinese Guidelines for the Diagnosis and Treatment of Polycystic Ovary Syndrome issued by the Endocrinology Group and Guideline Expert Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association, PCOS can be diagnosed if any two of the following indicators are met: (1) infrequent ovulation or anovulation; (2) hyperandrogenemia or clinical manifestations of hyperandrogenemia (such as hirsutism, acne, etc.). (3) Ultrasound examination shows that there are ≥12 small follicles with a diameter of 2-9 mm in both ovaries, and / or the ovarian volume is ≥10 ml (ovarian volume is calculated as 0.5 × diameter × transverse diameter × anteroposterior diameter); 2. Abnormal vaginal discharge; 3. Exclude hyperandrogenemia or hyperandrogen symptoms caused by other causes such as Cushing's syndrome, non-classical congenital adrenal hyperplasia, and tumors of the ovary or adrenal gland that secrete androgens; 3. Exclude ovulation disorders caused by functional hypothalamic amenorrhea, thyroid disease, hyperPRLemia, premature ovarian insufficiency, etc.; 4. Have not taken hormone drugs in the past 3 months; 5. No other serious diseases or chronic diseases, and no serious mental illness; 6. Able to actively cooperate with treatment, and willing to accept treatment.

[0088] Subjects were randomly divided into 8 groups and received interventions with the 8 test samples listed in Table 3 for a period of 6 months. The androgen levels and self-report questionnaires (including dysmenorrhea severity, menstrual frequency, and vaginal health) of the subjects before and after the intervention were used as observation indicators to evaluate the improvement effects of the test samples on PCOS and vaginal environment.

[0089] 2.2 Observation Indicators

[0090] 2.2.1. Serum free testosterone levels

[0091] 2.2.2 Self-assessment questionnaire

[0092] (1) Severity of dysmenorrhea: The Visual Analogue Scale (VAS) was used, allowing patients to select a score based on their own feelings. 0 points represented no pain, and 10 points represented the most severe pain. VAS efficacy index (n) = (self-reported score before intervention - self-reported score after intervention) / self-reported score before intervention × 100%. Cure: VAS score decreased to 100%; Significant effect: VAS score decreased to 50% or more; Effective: VAS score decreased to 25%-50%; Ineffective: VAS score decreased by less than 25%.

[0093] (2) Menstrual frequency: Record the number of days in the most recent menstrual cycle before the intervention and the number of days in the last menstrual cycle after the intervention;

[0094] (3) Vaginal health score: A. Amount of vaginal discharge: 2 points for small amount, 1 point for moderate amount, 0 points for large amount; B. Characteristics of vaginal discharge: 1 point for thin, 0 points for thick; C. Odor of vaginal discharge: 1 point for odorless, 0 points for odorous; D. Color of vaginal discharge: 3 points for clear color, 2 points for light yellow, 1 point for yellow, 0 points for green.

[0095] 2.3 Test Results

[0096] 2.3.1 Changes in serum free testosterone levels

[0097] The changes in serum free testosterone levels before and after intervention in each group are shown in Table 4:

[0098] Table 4. Serum free testosterone levels and improvement in each group of subjects.

[0099]

[0100] High androgen levels are one of the main indicators of PCOS and a significant factor leading to menstrual irregularities. High androgen levels can cause a range of hyperandrogen symptoms, such as hair loss, acne, obesity, increased body hair, and acanthosis nigricans. After a 6-month intervention, only the subjects in Example 1 showed a significant decrease in average serum testosterone levels, a reduction of 33.9%. Comparative groups 1-5 also showed a certain degree of decrease in testosterone levels, but the reduction was smaller. This indicates that the combination of red ginseng powder / red ginseng extract, cinnamon powder, and NWH lactic acid bacteria compound powder within a certain ratio can synergistically reduce androgen levels in PCOS patients, with effects far exceeding those of using any three ingredients individually. Comparative group 6 also showed a certain degree of decrease in testosterone levels, but the reduction was smaller. This demonstrates that the combination of cinnamon powder prepared using a specific method and red ginseng powder / red ginseng extract, along with NWH lactic acid bacteria compound powder, is far more effective than cinnamon powder prepared using conventional extraction processes.

[0101] 2.3.2 Improvement in the severity of dysmenorrhea

[0102] Table 5 shows the improvement in the degree of dysmenorrhea before and after intervention in each group.

[0103] Table 5. Degree of improvement in dysmenorrhea and corresponding number of participants in each group.

[0104]

[0105] As shown in Table 5, after 6 months of intervention, the effective rate of dysmenorrhea improvement in the subjects of Example 1 group reached 96%, with 20% of subjects reporting no longer experiencing dysmenorrhea and 64% reporting significant improvement in dysmenorrhea. A small number of subjects in Comparative Examples 1-5 also experienced improvement in dysmenorrhea, but the effective rate was low. This indicates that the combination of red ginseng powder / red ginseng extract, cinnamon powder, and NWH lactic acid bacteria compound powder within a specific ratio range can synergistically improve dysmenorrhea, with effects far exceeding those of using the three ingredients individually. A small number of subjects in Comparative Example 6 also experienced improvement in dysmenorrhea, but the effective rate was low. This indicates that the combination of cinnamon powder prepared using a specific method and red ginseng powder / red ginseng extract, along with NWH lactic acid bacteria compound powder, has a far greater effect on improving dysmenorrhea than cinnamon powder prepared using conventional extraction processes.

[0106] 2.3.3 Menstrual cycle regulation

[0107] PCOS patients often experience infrequent or even anovulatory ovulation, which manifests as longer menstrual cycles. Figure 1 For Example 1, the distribution of the average menstrual cycle of subjects before and after intervention in Comparative Examples 1-6 is shown in the figure. Figure 1 As shown, before the intervention, the average menstrual cycle of the subjects in each group was between 83 and 88 days. After the intervention, the average menstrual cycle of the group in Example 1 shortened to 39 days and tended to stabilize. The subjects in the control groups 1 and 2 (taking red ginseng powder or cinnamon powder alone), the control group 3 (taking cinnamon powder and NWH lactic acid bacteria compound powder), the control group 5 (taking powder not in a specific ratio), and the control group 6 (taking cinnamon powder prepared using conventional processes) all showed a shortening of their average menstrual cycle, but the magnitude was smaller than that in the group in Example 1, indicating a weaker improvement effect. The probiotic group alone showed almost no change. This demonstrates that the present invention can significantly improve infrequent ovulation in PCOS patients and supports the normalization of ovulation cycles.

[0108] 2.3.4 Vaginal health score

[0109] Vaginal health can be assessed through the state of vaginal discharge, including the amount, color, and odor. When the vagina is infected with bacteria or yeast, the discharge will increase, develop a fishy odor, and may be yellow or green, or even appear as a viscous substance. According to a set scoring standard, the higher the score, the more normal the discharge and the healthier the vaginal environment. Figure 2 This is a score chart showing the vaginal health of subjects before and after intervention in Example 1 and Comparative Examples 1-6. (Source: [Insert Source Here]) Figure 2As can be seen, the average scores of vaginal discharge status in the subjects of Example 1 were all higher than before the intervention, and the increase was greater than that in the control groups 1-6. This indicates that the combination of red ginseng powder, cinnamon powder, and NWH lactic acid bacteria compound powder within a specific ratio range can synergistically improve vaginal health, with effects far exceeding those of using the three raw materials alone. Furthermore, the combination of cinnamon powder prepared using a specific method with red ginseng powder and NWH lactic acid bacteria compound powder has a far greater effect on improving vaginal health than cinnamon powder prepared using conventional extraction processes. This demonstrates that the present invention can synergistically regulate the vaginal environment and improve vaginal infections.

[0110] The above description, in conjunction with specific embodiments, further illustrates the present invention. However, these embodiments are merely exemplary and do not constitute any limitation on the scope of the present invention. Those skilled in the art should understand that modifications or substitutions to the details and form of the technical solutions of the present invention can be made without departing from the spirit and scope of the invention, and all such modifications and substitutions fall within the protection scope of the present invention.

Claims

1. A composition characterized in that, Cassia powder, red ginseng powder and lactic acid bacteria compound powder NWH in a mass ratio of 0.1-10:0.2-10:1-10; The preparation method of the cassia powder comprises the following steps: S1, grinding and sieving the cassia dry skin to obtain cassia coarse powder; S2, adding water to the cassia coarse powder of step S1, mixing and soaking to obtain a mixture; S3, increasing the temperature of the mixture of step S2 to 75-85℃, and ultrasonic-assisted extracting for 10-20 min to obtain an extract; S4, filtering and concentrating the extract of step S3 to obtain a concentrated solution; S5, adding resistant dextrin to the concentrated solution of step S4, and drying to obtain the cassia powder. The lactic acid bacteria compound powder NWH is composed of Lactobacillus helveticus R0052, Lactobacillus rhamnosus R0011 and Lactobacillus reuteri HA188 in a proportion.

2. The composition of claim 1, wherein, It further comprises at least one of the following raw materials: probiotics, plant extracts, prebiotics, soy lecithin, collagen, elastin peptides, resveratrol, nutritional yeast powder, red dates, longan, black beans, brown sugar, donkey-hide gelatin, Chinese wolfberry and dried tangerine or orange peel.

3. Process for the preparation of a composition according to any one of claims 1-2, characterized in that, The method comprises the following steps: The lactic acid bacteria compound powder NWH, the cassia powder and the red ginseng powder are weighed according to the formula, and then uniformly mixed to obtain the composition.

4. The production method according to claim 3, characterized by, The preparation method of the cassia powder comprises the following steps: S1, grinding and sieving the cassia dry skin to obtain cassia coarse powder; S2, adding water to the cassia coarse powder of step S1, mixing and soaking to obtain a mixture; S3, increasing the temperature of the mixture of step S2 to 75-85℃, and ultrasonic-assisted extracting for 10-20 min to obtain an extract; S4, filtering and concentrating the extract of step S3 to obtain a concentrated solution; S5, adding resistant dextrin to the concentrated solution of step S4, and drying to obtain the cassia powder.

5. Use of the composition of any one of claims 1-2 in the preparation of a product for improving dysmenorrhea, regulating menstrual cycle and improving infectious vaginitis.

6. A product for improving dysmenorrhea, regulating menstrual cycle, improving infective vaginitis, characterized in that, The composition of any one of claims 1-2 is contained.

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