A composition for improving perimenopausal symptoms

Abstract

This invention belongs to the field of pharmaceutical technology, specifically relating to a composition for improving perimenopausal symptoms. It comprises the following components: 400-700 parts protein, 30-50 parts fat, 120-170 parts carbohydrates, 40-90 parts dietary fiber, 30-80 parts food-grade medicinal materials, 2-6 parts complex trace minerals, 50-95 parts complex macrominerals, 3-5 parts complex vitamins, and 5-10 parts blueberry powder. The protein is composed of whey protein, soy protein, and collagen peptides in a mass ratio of 7-12:6.1-8.5:1. By precisely controlling the ratio of soy protein and collagen peptides in the protein, this composition can significantly improve perimenopausal symptoms such as hot flashes, insomnia, osteoporosis, decreased estrogen levels, and uterine atrophy.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a composition for improving perimenopausal symptoms. Background Technology

[0002] Perimenopause refers to the period before and after menopause in women, including the menopausal transition period and the period after menopause. The average age at which Chinese women begin perimenopause is 46, and the average age of menopause is between 48 and 52. Approximately 90% of women experience menopause between the ages of 45 and 55, and it is projected that by 2030, the number of women aged 50 and above will exceed 280 million. Menopause is essentially the failure of ovarian function. The fluctuating decline and lack of estrogen leads to menopause-related symptoms such as menstrual irregularities, hot flashes and sweating, sleep disturbances, mood changes, and general muscle and joint pain. Furthermore, long-term estrogen deficiency can increase the risk of metabolic diseases, including abnormalities in calcium metabolism and glucose and lipid metabolism, such as osteoporosis and cardiovascular diseases. Approximately 80% of women experience at least one menopause-related symptom. The physiological and pathological changes that occur during this stage can negatively impact the quality of life of middle-aged women, and if not addressed, may lead to serious physical and mental illnesses that persist into later life.

[0003] As ovarian function gradually declines and estrogen levels decrease in women, the metabolism of various nutrients changes accordingly, leading to a significant increase in the incidence of various metabolic diseases. Due to the loss of the protective effect of estrogen, postmenopausal women are more prone to obesity / overweight, metabolic syndrome, insulin resistance, glucose and lipid metabolism disorders, and loss of bone mass and lean body mass. These unique pathophysiological characteristics dictate that continuous and appropriate nutritional management, which is crucial for metabolic improvement, must play a fundamental role in promoting health during this special physiological stage of women. Therefore, nutritional health management for perimenopausal women, and early identification and proactive intervention of perimenopausal problems, are of paramount importance.

[0004] Research reports that the principles of nutritional therapy for women entering perimenopause are: while ensuring and meeting the necessary energy needs for physical activity, control total calorie intake, appropriately limit the intake of animal products, reduce the content of saturated fatty acids and cholesterol in food, ensure sufficient vitamins and minerals, consume more fresh vegetables, and control the amount of salt and cooking oil used (Chinese Medical Association Clinical Nutrition Training Project Office, Nutritional Therapy for Perimenopausal Syndrome [J]). However, self-planning a diet under professional advice requires more time and effort for research and preparation, while purchasing corresponding nutritional supplements is relatively convenient and time-saving. However, there are currently no nutritional supplements that combine the protein, carbohydrates, fats, vitamins, and other components required in the diet to improve perimenopausal symptoms in perimenopausal women. Summary of the Invention

[0005] To address the shortcomings of existing technologies and practical needs, this invention proposes a complete nutritional composition specifically designed for perimenopausal women. This composition aims to alleviate anxiety and hot flashes in perimenopausal women and improve their sleep.

[0006] To achieve the above objectives, the present invention provides a composition for improving perimenopausal symptoms, comprising the following components:

[0007] 400-700 parts of protein, 30-50 parts of fat, 120-170 parts of carbohydrate, 40-90 parts of dietary fiber, 30-80 parts of food and medicine homology, 2-6 parts of complex trace minerals, 50-95 parts of complex macro minerals, 3-5 parts of complex vitamins, and 5-10 parts of blueberry powder.

[0008] The protein-like substance is composed of whey protein, soy protein, and collagen peptides in a mass ratio of 7~12:6.1~8.5:1;

[0009] The carbohydrate substance is composed of maltodextrin and solid corn syrup;

[0010] The medicinal and edible homologous substances are composed of wolfberry powder, lily powder, lotus seed powder, longan powder, red date powder, and jujube seed powder;

[0011] The fatty substance is composed of plant oil microcapsule powder and fish oil;

[0012] The vegetable oil microcapsule powder is made by mixing medium-chain triglycerides, soybean oil, and low-erucic acid rapeseed oil with an edible carrier.

[0013] The dietary fiber is composed of resistant dextrin and fructooligosaccharides;

[0014] The composite trace minerals are made from a mixture of copper sulfate, ferric pyrophosphate, manganese sulfate, sodium selenite, potassium iodide, and zinc citrate.

[0015] The composite macro-mineral is made from a mixture of calcium carbonate, magnesium carbonate, potassium citrate, and potassium dihydrogen phosphate.

[0016] The multivitamin is made from a mixture of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, pantothenic acid, vitamin B6, vitamin B12, vitamin C, biotin, folic acid, and niacin.

[0017] Furthermore, it consists of the following components:

[0018] 400-500 parts protein, 30-40 parts fat, 120-130 parts carbohydrate, 60-70 parts dietary fiber, 50-60 parts food and medicine homology, 3-3.5 parts complex trace minerals, 70-75 parts complex macro minerals, 3-4 parts complex vitamins, and 8-8.5 parts blueberry powder;

[0019] Furthermore, it is composed of the following components:

[0020] 488 samples of protein, 36 samples of fat, 121 samples of carbohydrate, 62 samples of dietary fiber, 58 samples of food and medicine homology, 3.1 samples of complex trace minerals, 72 samples of complex macro minerals, 3.5 samples of complex vitamins, and 8.1 samples of blueberry powder.

[0021] Furthermore, the protein-like substance is composed of whey protein, soy protein, and collagen peptides in a mass ratio of 12:8.5:1;

[0022] Alternatively: Composed of whey protein, soy protein, and collagen peptides in a mass ratio of 7:6.1:1;

[0023] Furthermore, the mass ratio of resistant dextrin to fructooligosaccharides in the dietary fiber is 1~2:1.

[0024] Furthermore, the mass ratio of copper sulfate, ferric pyrophosphate, manganese sulfate, sodium selenite, potassium iodide, and zinc citrate in the composite trace minerals is 7~8:15~16:45~46:5~6:9~10:10;

[0025] The mass ratio of calcium carbonate, magnesium carbonate, potassium citrate, and potassium dihydrogen phosphate in the composite macromineral is 1~2:0.5~1:1~2:1.

[0026] Furthermore, the mass ratio of medium-chain triglycerides, soybean oil, low-erucic acid rapeseed oil, and fish oil in the fatty substances is 5~6:7~8:2~3:1; the edible carrier is maltodextrin.

[0027] Furthermore, the mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, pantothenic acid, vitamin B6, vitamin B12, vitamin C, biotin, folic acid, and niacin in the compound vitamin is 0.5~0.6:0.008~0.009:18~19:1~2:1~2:4~5:3~4:0.003~0.005:72~73:0.02~0.04:0.2~0.3:10.

[0028] Furthermore, the mass ratio of wolfberry powder, lily powder, lotus seed powder, longan powder, red date powder, and jujube seed powder in the aforementioned food-medicine homology substance is 6~7:8~9:8~9:7~8:12~13:10;

[0029] The mass ratio of maltodextrin to solid corn syrup in the carbohydrates is 2-3:1.

[0030] The present invention also provides the use of the aforementioned composition in the preparation of a medicament for improving perimenopausal symptoms, said perimenopausal symptoms including hot flashes, insomnia, osteoporosis, decreased estrogen levels, and uterine atrophy.

[0031] The "red dates" described in this invention belong to the category of jujubes in the Complete Catalogue of Food and Medicine with the Same Origin, and are red or dark red in appearance.

[0032] The beneficial effects of this invention are:

[0033] This invention's composition selects a variety of high-quality proteins. Soy protein, rich in soy isoflavones, can alleviate symptoms such as hot flashes and night sweats, improve ovarian function, prevent osteoporosis, and support cardiovascular health. Whey protein, rich in various essential amino acids and bioactive substances, provides high-quality protein, enhances immunity, and helps promote calcium absorption, thereby increasing bone density. Collagen peptides are specially added, making it easy to digest and absorb, and can also promote collagen synthesis in the body, alleviating skin aging and bone and joint problems. Soluble dietary fiber improves the intestinal flora environment and effectively controls blood sugar and weight levels. Omega-3 fatty acids from fish oil... It helps alleviate hot flashes and mood swings, and reduces the risk of cardiovascular disease; multiple vitamins and minerals, including vitamin D and calcium, help maintain bone density and prevent osteoporosis; vitamins A, E, selenium, and zinc have antioxidant effects, support immune function, and protect cardiovascular health; blueberry powder has antioxidant and anti-inflammatory effects; food-grade medicinal ingredients, such as goji berry powder, nourish the liver and kidneys, benefit essence and improve eyesight, and can relieve perimenopausal symptoms such as dizziness and tinnitus; lily powder, lotus seed powder, and jujube seed powder nourish the heart and calm the mind, helping to relieve sleep disorders, palpitations, and fatigue; longan powder and red date powder replenish qi and can improve forgetfulness and insomnia. These active ingredients are combined in specific proportions, especially the soy protein and collagen peptides in the protein. By precisely controlling the ratio of these two when the protein composition is constant, perimenopausal symptoms such as hot flashes, insomnia, osteoporosis, decreased estrogen levels, and uterine atrophy can be significantly improved.

[0034] Animal experiments have determined that the efficacy of each component in the composition of this invention is affected by the proteins soy protein and collagen peptides. When the protein in the composition consists of whey protein, soy protein, and collagen peptides, and the mass ratio of the three proteins is controlled at 7~12:6.1~8.5:1, the functional components work synergistically and have a significant effect on improving perimenopausal symptoms. In particular, when the mass ratio of whey protein, soy protein, and collagen peptides is 12:8.5:1, the improvement effect on various perimenopausal symptoms is particularly outstanding, which has practical application value.

[0035] Obviously, based on the above description of the present invention, and according to common technical knowledge and conventional methods in the field, various other modifications, substitutions or alterations can be made without departing from the basic technical concept of the present invention.

[0036] The following detailed embodiments further illustrate the above-described content of the present invention. However, this should not be construed as limiting the scope of the present invention to the following examples. All technologies implemented based on the above-described content of the present invention fall within the scope of the present invention. Attached Figure Description

[0037] Figure 1 A graph showing the skin temperature of a rat's tail;

[0038] Figure 2 A graph of the rat uterine index;

[0039] Figure 3 A graph showing the results of E2 detection in rats;

[0040] Figure 4 A graph showing the results of FSH and LH tests in rats;

[0041] Figure 5 A graph showing the results of bone mineral density testing in the femur of a rat;

[0042] Figure 6 A graph showing the sleep latency and sleep duration of mice. Detailed Implementation

[0043] The raw materials and equipment used in the specific embodiments of this invention can all be purchased commercially. Among them, the low erucic acid rapeseed oil is rapeseed oil with an erucic acid content of no more than 3% of the fatty acid composition; the oligofructose is an oligosaccharide formed by sucrose and 1 to 3 fructose groups linked to the fructose groups in sucrose through β-(2→1)-glycosidic bonds; the oligomaltose is an oligosaccharide formed by 3 to 10 glucose groups linked through α-1,4 glycosidic bonds.

[0044] Example 1: Preparation of the nutritional composition of the present invention

[0045] Formula: 488 parts protein, 36 parts fat, 121 parts carbohydrate, 62 parts dietary fiber, 58 parts food and medicine homology, 3.1 parts complex trace minerals, 72 parts complex macro minerals, 3.5 parts complex vitamins, and 8.1 parts blueberry powder;

[0046] The protein-containing substances are composed of whey protein, soy protein, and collagen peptides in a mass ratio of 12:8.5:1, namely 272.37 parts whey protein, 192.93 parts soy protein, and 22.70 parts collagen peptides.

[0047] The fatty substances are composed of vegetable oil microcapsule powder and fish oil; the vegetable oil microcapsule powder is made by mixing medium-chain triglycerides, soybean oil and low-erucic acid rapeseed oil with edible carrier oligomaltose; the mass ratio of medium-chain triglycerides, soybean oil, low-erucic acid rapeseed oil and fish oil in the fatty substances is 5.2:7.1:2.5:1, that is, 9.8 parts of medium-chain triglycerides, 13.4 parts of soybean oil, 4.8 parts of low-erucic acid rapeseed oil, 1.9 parts of fish oil, and the remainder is oligomaltose.

[0048] The carbohydrates consist of maltodextrin and solid corn syrup in a mass ratio of 2.8:1, namely 89.2 parts maltodextrin and 31.8 parts solid corn syrup.

[0049] Dietary fiber is composed of resistant dextrin and fructooligosaccharides in a mass ratio of 1.64:1, namely 38.5 parts resistant dextrin and 23.5 parts fructooligosaccharides.

[0050] The food-medicine homology substance is composed of wolfberry powder, lily powder, lotus seed powder, longan powder, red date powder, and jujube seed powder in a mass ratio of 6.2:8.1:8.6:7.4:12.1:10, namely 6.86 parts wolfberry powder, 8.97 parts lily powder, 9.52 parts lotus seed powder, 8.19 parts longan powder, 13.39 parts red date powder, and 11.07 parts jujube seed powder.

[0051] The complex trace minerals are composed of copper sulfate, ferric pyrophosphate, manganese sulfate, sodium selenite, potassium iodide, and zinc citrate in a mass ratio of 7.38:15.93:45.24:5.07:9.10:10, specifically 0.2467 parts copper sulfate, 0.5326 parts ferric pyrophosphate, 1.5126 parts manganese sulfate, 0.1695 parts sodium selenite, 0.3043 parts potassium iodide, and 0.3343 parts zinc citrate.

[0052] The complex macro-minerals are composed of calcium carbonate, magnesium carbonate, potassium citrate, and potassium dihydrogen phosphate in a mass ratio of 1.85:0.53:1.58:1, namely 26.85 parts calcium carbonate, 7.69 parts magnesium carbonate, 22.94 parts potassium citrate, and 14.52 parts potassium dihydrogen phosphate.

[0053] The multivitamin is composed of vitamins A, D, E, B1, B2, pantothenic acid, B6, B12, C, biotin, folic acid, and niacin in a mass ratio of 0.55:0.009:18.21:1.35:1.26:4.62:3.5:0.004:72.16:0.03:0.28:10, specifically: 0.0172 parts of vitamin A, 0.0003 parts of vitamin D, 0.5692 parts of vitamin E, 0.042 parts of vitamin B1, 0.0394 parts of vitamin B2, 0.1444 parts of pantothenic acid, 0.1094 parts of vitamin B6, 0.0001 parts of vitamin B12, 2.2555 parts of vitamin C, 0.0009 parts of biotin, 0.0088 parts of folic acid, and 0.3126 parts of niacin.

[0054] Preparation method: Weigh the raw materials according to the formula, and add fish oil, compound vitamins, compound trace minerals, wolfberry powder, lily powder, blueberry powder, red date powder, lotus seed powder, longan powder, jujube seed powder, maltodextrin, compound macro minerals, solid corn syrup, vegetable oil microcapsule powder, resistant dextrin, fructooligosaccharides, and collagen peptides in sequence, and mix for 30 minutes; then add whey protein and soy protein, and mix for 60 minutes to obtain the finished product.

[0055] Example 2 Preparation of the nutritional composition of the present invention

[0056] This embodiment is basically the same as Embodiment 1, except that the protein-like substance is composed of whey protein, soy protein and collagen peptide in a mass ratio of 7:6.1:1, that is, 242.27 parts of whey protein, 211.12 parts of soy protein and 34.61 parts of collagen peptide. The rest is the same as in Embodiment 1.

[0057] Comparative Example 3: Preparation of the nutritional composition of the present invention

[0058] This embodiment is basically the same as Embodiment 1, except that the protein-like substance is composed of whey protein, soy protein and collagen peptide in a mass ratio of 4.5:2.7:1, that is, 267.80 parts of whey protein, 160.68 parts of soy protein and 59.51 parts of collagen peptide. The rest is the same as in Embodiment 1.

[0059] Comparative Example 4: Preparation of the nutritional composition of the present invention

[0060] This embodiment is basically the same as Embodiment 1, except that the protein substance is 488 parts of whey protein, and everything else is the same as in Embodiment 1.

[0061] The following experimental examples further illustrate the beneficial effects of the present invention:

[0062] Experimental Example 1: Study on the effect of the nutritional composition of the present invention on improving perimenopausal symptoms

[0063] 1. Experimental Methods

[0064] Sixty SPF-grade 2-month-old female SD rats, weighing 180-220g at purchase, and one SPF-grade 1-month-old female ICR mice, weighing 19-23g at purchase, were purchased. The animals were housed in a clean environment with constant temperature and humidity (temperature 22-25°C, humidity 65%-70%), with a 12-hour light and 12-hour dark cycle, and in a well-ventilated environment with free access to food and water.

[0065] After one week of acclimatization, rats and mice were randomly divided into 6 groups (n=10 per group): rats: blank control group (sham operation group), model group, Example 1 group, Example 2 group, comparative example 3 group, and comparative example 4 group; mice: blank control group (sham operation group), model group, Example 1 group, Example 2 group, comparative example 3 group, and comparative example 4 group. In the model group, Example 1 group, Example 2 group, comparative example 3 group, and comparative example 4 group, the abdominal cavity of rats and mice was incised, bilateral ovaries were removed, and the incision was sutured to establish perimenopausal rat and mouse models. In the blank control group (sham operation group), the abdominal cavity of rats and mice was incised, some adipose tissue around the ovaries was removed, and the incision was sutured. Antibiotics were administered for three consecutive days postoperatively to prevent infection.

[0066] Intervention began one week after surgery. Rats and mice in Example 1, Example 2, Comparative Example 3, and Comparative Example 4 were administered an aqueous solution (0.2 g / ml) of the nutrient composition of Example 1, Example 2, Comparative Example 3, and Comparative Example 4 by gavage, at a dose of 2 g / kg BW. The blank control group and model group of rats and mice were administered the same amount of distilled water by gavage daily. Rats were administered the solution by gavage for 12 consecutive weeks, and mice for 4 consecutive weeks.

[0067] The formulations of the nutritional compositions administered by gavage to each treatment group are listed below:

[0068] Table 1. Summary of Dosage Formulations for Each Group

[0069]

[0070]

[0071] For rats, 24 hours after the last gavage, body weight and tail skin temperature were measured. After anesthesia, blood was collected from the abdominal aorta, serum was separated and stored, and the uterus was removed, weighed, and recorded before being stored at -80°C. After euthanasia, the right femur of the rat was removed, and any attached muscle and soft tissue were removed. It was then stored in 4% paraformaldehyde for subsequent experimental analysis.

[0072] For mice, 1 hour after the last gavage, each group of mice was intraperitoneally injected with a threshold dose of sodium pentobarbital (40 mg / kg). The disappearance of the righting reflex was used as the indicator of falling asleep, and the recovery of the righting reflex was used as the indicator of awakening. The sleep latency and sleep duration of each group of mice were recorded.

[0073] 1.1 Tail temperature

[0074] Hot flashes are a typical symptom of perimenopausal syndrome in women, accompanied by other symptoms such as chest tightness and anxiety, affecting their quality of life. This study measured the skin temperature of the rat tail to evaluate the effect of an intervention on improving hot flash symptoms in perimenopausal rats.

[0075] Results of rat tail skin temperature Figure 1 As shown, the tail temperature of rats in the model group was significantly higher than that in the control group (P<0.05), while the tail temperatures of the other four groups all increased to varying degrees. The tail temperatures of rats in Example 1 and Example 2 were significantly lower than those in the model group (P<0.05), indicating that Example 1 and Example 2 can effectively inhibit the abnormal increase in body temperature in perimenopausal rats and alleviate hot flash symptoms. The tail temperature of rats in Example 1 was lower than that in Example 2, showing a more significant effect.

[0076] 1.2 Uterine Index

[0077] The uterine index (uterine weight as a percentage of body weight) in rats is an important parameter reflecting perimenopausal status and estrogen levels. During perimenopause, due to the decline in ovarian function and reduced estrogen secretion, uterine atrophy occurs, leading to a significant decrease in the uterine index. The uterine index is calculated by weighing the wet weight of the rat uterus and calculating its ratio to body weight, reflecting uterine development and assessing the effect of interventions on uterine development in perimenopausal model rats.

[0078] Rat uterine index results as follows Figure 2 As shown, the uterine index in the model group was significantly lower than that in the control group (P<0.05), while the uterine index in Example 1 and Example 2 groups was significantly higher than that in the model group (P<0.05). Comparative Example 3 and Comparative Example 4 groups could improve the uterine index of perimenopausal model rats to some extent, but the effect was not statistically significant. The intervention in Example 1 group could effectively promote normal uterine development and alleviate perimenopausal symptoms, with better results than that in Example 2 group.

[0079] 1.3 Estradiol (E2)

[0080] Estradiol (E2) is an important estrogen, belonging to the steroid hormone class, secreted by the follicular cells of the ovary, and is the most biologically active estrogen. Estradiol plays a crucial role in menstrual regulation, reproductive health, bone metabolism, and cardiovascular protection. After entering perimenopause, ovarian function gradually declines, and E2 levels drop sharply, leading to a series of perimenopausal symptoms, including hot flashes, night sweats, osteoporosis, and an increased risk of cardiovascular disease. This study used an ELISA kit to detect serum E2 levels in rats of different groups to assess the effect of interventions on E2 levels in a perimenopausal rat model.

[0081] The results of E2 detection in rats are as follows Figure 3 As shown, the E2 level in the model group was significantly lower than that in the control group (P<0.05). The level in the Example 1 group was close to that in the control group and significantly higher than that in the model group (P<0.05). The E2 level in the Example 2 group was also significantly higher than that in the model group (P<0.05), but lower than that in the Example 1 group. This indicates that the intervention in the Example 1 group had the best effect on improving the decline in estrogen levels in rats during perimenopause, followed by the Example 2 group. Comparison groups 3 and 4 had no significant effect on improving the decline in estrogen levels during perimenopause.

[0082] 1.4 Serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH)

[0083] Serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in rats are important physiological indicators for assessing perimenopausal status. Perimenopausal syndrome leads to abnormally elevated FSH and LH levels, disrupting hormonal balance and exacerbating the health effects of perimenopause. Detecting serum FSH and LH levels in rats using an ELISA kit can indirectly reflect their estrogen secretion and perimenopausal status.

[0084] The results of rat FSH and LH tests are as follows: Figure 4 As shown, FSH and LH in the model group were significantly higher than those in the control group (P<0.05), while FSH and LH in Example 1 group were significantly lower than those in the model group (P<0.05). FSH in Example 2 group was significantly different from that in the model group, but slightly higher than that in Example 1 group. This indicates that Example 1 group had the best effect in inhibiting the abnormal increase of FSH and LH in perimenopausal rats and maintaining hormonal balance, followed by Example 2 group. Comparison groups 3 and 4 showed no significant effect in maintaining estrogen balance during perimenopause.

[0085] 1.5 Femoral bone mineral density

[0086] Perimenopausal osteoporosis is a common disease caused by a decline in estrogen levels leading to an imbalance in bone metabolism. It is mainly characterized by decreased bone mineral density and bone structure destruction, thereby increasing the risk of fractures. Dual-energy X-ray absorptiometry (DXA) was used to measure bone mineral density at the midpoint and distal femur of rats to evaluate the effects of various interventions on bone mineral density in perimenopausal rats.

[0087] The results of rat femoral bone mineral density testing are as follows: Figure 5 As shown, the femoral mineral density in the model group was significantly lower than that in the control group (P<0.05). The femoral mineral density at both the distal and midpoint of the femur in Example 1 group was significantly higher than that in the model group (P<0.05), and also higher than that in Example 2, Comparative Example 3, and Comparative Example 4. The femoral mineral density at the distal end of the femur in Example 2 group was significantly different from that in the model group (P<0.05). This indicates that Example 1 has the best effect in improving bone mineral density and preventing osteoporosis in perimenopausal rats, followed by Example 2. Comparative Example 3 and 4 showed no significant effect in improving perimenopausal bone mineral density.

[0088] 1.6 Mouse Sleep Experiment

[0089] Insomnia is a significant symptom of perimenopausal syndrome, with patients experiencing difficulty falling asleep, frequent awakenings at night, and vivid dreams, severely impacting their quality of life. This study investigated the effects of different interventions on sleep in perimenopausal model mice by prolonging sodium pentobarbital sleep time after intervention.

[0090] Mouse sleep latency and sleep duration, as follows Figure 6 As shown, compared with the control group, the model group had a significantly prolonged sleep latency (P<0.05) and a significantly shortened sleep duration (P<0.05). Both Example 1 and Example 2 groups showed significantly shorter sleep latency and longer sleep duration compared to the model group (P<0.05). Example 1 group had a shorter sleep latency and longer sleep duration than Example 2 group, indicating a more significant effect. Comparative Examples 3 and 4 showed no significant effect on improving perimenopausal sleep.

[0091] The above results indicate that the interventions in both Example 1 and Example 2 groups can promote uterine development, improve estrogen secretion, maintain hormonal balance, alleviate perimenopausal hot flashes, and increase bone density in perimenopausal rat models. They also improve insomnia in perimenopausal mice, shortening sleep latency and prolonging sleep time. Therefore, both Example 1 and Example 2 groups have the effect of alleviating and treating perimenopausal syndrome, with Example 1 showing better intervention effects.

[0092] The main difference between the compositions of Examples 1-2 and Comparative Example 4 used in the animal experiments lies in the presence or absence of soy protein and collagen peptides in the protein, indicating that soy protein and collagen peptides in the composition have a significant impact on the intervention effect. The main difference between the compositions of Examples 1-2 and Comparative Example 3 lies in the ratio of soy protein and collagen peptides in the protein. The composition of Comparative Example 3 contains 160.68 parts of soy protein, significantly lower than the 192.93-211.12 parts of soy protein in Examples 1-2, and 59.51 parts of collagen peptides, significantly higher than the compositions of Examples 1-2. In Examples 1 and 2, the collagen peptides in the compositions ranged from 22.70 to 34.61 parts, indicating that the addition of soy protein and collagen peptides, along with controlling the ratio of the two proteins, is necessary to improve perimenopausal symptoms. The main difference between the compositions of Example 1 and Example 2 is the proportion of whey protein in the protein. The whey protein in the composition of Example 2 was 242.27 parts, which is significantly lower than the whey protein in the composition of Example 1 (272.37 parts). This shows that controlling the ratio of soy protein and collagen peptides in the protein, while also controlling the proportion of whey protein, can maximize the improvement effect on perimenopausal syndrome symptoms.

[0093] In summary, the composition of this invention combines the nutritional and functional characteristics of each component. Based on this, when the mass ratio of whey protein, soy protein, and collagen peptides is controlled at 7~12:6.1~8.5:1, the various functional components work synergistically, resulting in significant effects in improving perimenopausal symptoms. In particular, when the mass ratio of whey protein, soy protein, and collagen peptides is 12:8.5:1, the improvement effect on various perimenopausal symptoms is particularly outstanding, making it worthy of practical application.

Claims

1. Use of a composition for the manufacture of a medicament for improving perimenstrual symptoms, characterized in that: The perimenopausal symptoms are hot flashes, insomnia, estrogen level reduction, and uterus atrophy; The composition is composed of: 488 parts of protein substances, 36 parts of fat substances, 121 parts of carbohydrate substances, 62 parts of dietary fiber substances, 58 parts of medicinal and edible substances, 3.1 parts of complex trace minerals, 72 parts of complex macro minerals, 3.5 parts of complex vitamins, 8.1 parts of blueberry powder; The protein substances are composed of whey protein, soy protein and collagen peptide at a mass ratio of 12:8.5:1; The carbohydrate substances are composed of malt dextrin and solid corn syrup; The medicinal and edible substances are composed of wolfberry powder, lily powder, lotus seed powder, longan powder, red date powder and jujube seed powder; The fat substances are composed of plant oil microcapsule powder and fish oil; The plant oil microcapsule powder is prepared by mixing medium-chain triglyceride, soybean oil and low erucic rapeseed oil with edible carriers; The dietary fiber substances are composed of resistant dextrin and fructooligosaccharide; The complex trace minerals are prepared by mixing copper sulfate, ferric pyrophosphate, manganese sulfate, sodium selenite, potassium iodide and zinc citrate; The complex macro minerals are prepared by mixing calcium carbonate, magnesium carbonate, potassium citrate and potassium dihydrogen phosphate; The complex vitamins are prepared by mixing vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, pantothenic acid, vitamin B6, vitamin B12, vitamin C, biotin, folic acid and niacin.

2. Use according to claim 1, characterized in that: The mass ratio of resistant dextrin to fructooligosaccharide in the dietary fiber substances is 1-2:

1.

3. Use according to claim 1, characterized in that: The mass ratio of copper sulfate, ferric pyrophosphate, manganese sulfate, sodium selenite, potassium iodide and zinc citrate in the complex trace minerals is 7-8:15-16:45-46:5-6:9-10:

10. The mass ratio of calcium carbonate, magnesium carbonate, potassium citrate and potassium dihydrogen phosphate in the complex macro minerals is 1-2:0.5-1:1-2:

1.

4. Use according to claim 1, characterized in that: The mass ratio of medium-chain triglyceride, soybean oil, low erucic rapeseed oil and fish oil in the fat substances is 5-6:7-8:2-3:1; and the edible carrier is maltotriose.

5. Use according to claim 1, characterized in that: The mass ratio of vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, pantothenic acid, vitamin B6, vitamin B12, vitamin C, biotin, folic acid and niacin in the complex vitamins is 0.5-0.6:0.008-0.009:18-19:1-2:1-2:4-5:3-4:0.003-0.005:72-73:0.02-0.04:0.2-0.3:

10.

6. Use according to claim 1, characterized in that: The mass ratio of wolfberry powder, lily powder, lotus seed powder, longan powder, red date powder and jujube seed powder in the medicinal and edible substances is 6-7:8-9:8-9:7-8:12-13:

10. The mass ratio of malt dextrin to solid corn syrup in the carbohydrate substances is 2-3:1.

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