Health-care food composition and preparation method thereof

Abstract

The invention discloses a composition for improving perimenopausal syndrome and a preparation method thereof, and the composition comprises the following components in parts by weight: 10-25 parts of spina date seed, 10-25 parts of poria cocos, 10-25 parts of Chinese yam, 5-15 parts of wolfberry, 5-15 parts of rhizoma polygonati, 5-15 parts of mulberry, 5-15 parts of raspberry, 1-10 parts of paeonia ostii, 1-10 parts of double-petal red rose, 1-5 parts of liquorice, 1-5 parts of humulus lupulus and 2-8 parts of pollen pini. The composition for improving the perimenopausal syndrome, provided by the invention, has the main effects of nourishing kidney and replenishing essence, nourishing yin and suppressing yang, regulating yin and yang balance, regulating viscera disorder, improving ovary microcirculation, and improving various perimenopausal female symptoms such as dysphoria and palpitation, hectic fever, anxiety and depression, insomnia and amnesia, frequent urination and the like. Animal experiment research shows that the composition can regulate the in-vivo disordered hormone level and relieve sexual organ atrophy, has the effects of improving various syndromes of female perimenopause and regulating the hormone level, and is free of toxic and side effects.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a health food composition and a preparation method thereof. Background Art

[0002] Perimenopause is a stage that women must go through when they enter old age from the childbearing age. It is the age stage when women transition from a state of vigorous reproductive function to an age stage when they have no reproductive function, that is, from the beginning of the decline of ovarian function to one year after the last menstruation, that is, the menopausal transition period plus one year after menopause. Modern medicine believes that the physiological characteristics of perimenopausal women are mainly menstrual changes, with atrophic changes in reproductive organs, accompanied by neuropsychiatric symptoms, urinary system, cardiovascular system, secondary sexual characteristics and changes in bones. About 1 / 3 of perimenopausal women can achieve a new balance through neuroendocrine self-regulation without conscious symptoms, while 2 / 3 of women experience a series of symptoms caused by a decrease in sex hormones, such as menstrual disorders, hot flashes, dizziness, headaches, tinnitus, palpitations, insomnia, back pain, facial swelling, limb swelling, irritability, anxiety, depression, frequent urination at night, urinary incontinence, etc., which is called perimenopausal syndrome. About 40% of them affect their work and normal life, seriously endangering the physical and mental health of middle-aged and elderly women. With the continuous aging of my country's population structure, increasingly fierce social competition, poor working environment, mental factors and other influences, the disease has shown a trend of earlier onset age and higher incidence rate, and has been increasingly valued by society.

[0003] Perimenopausal syndrome is a series of symptoms and signs mainly caused by autonomic nervous system disorders due to ovarian dysfunction and decreased estrogen levels. It belongs to the category of "pre-menopausal syndromes" in TCM gynecology. Perimenopausal women are mainly caused by kidney deficiency, because the kidney is the source of Tiangui, the root of Chong and Ren meridians, and the root of Qi and blood. When women enter the perimenopausal period, kidney qi gradually declines, Ren meridian is weak and Chong meridian is insufficient, Tiangui is about to be exhausted, Yin and Yang are unbalanced, Qi and blood are not adjusted, and eventually natural menopause occurs, reproductive organs begin to atrophy, fertility is lost, and body functions gradually decline. "Suwen Shanggu Tianzhen Lun" says: "At the age of 77, Ren meridian is weak, Taichong meridian is weak, Tiangui is exhausted, and the earth channel is blocked, so the body has a shape but no children." The kidney stores the original Yin and Yang, "the Yin Qi of the five internal organs cannot be nourished without it, and the Yang Qi of the five internal organs cannot be developed without it", so the imbalance of Yin and Yang in the kidney often affects other organs such as the heart, liver, and spleen, and a series of symptoms of the nervous, cardiovascular, motor and urogenital systems appear. If perimenopausal women have kidney deficiency and kidney qi deficiency, the bladder qi transformation is not good, and urine cannot be retained, resulting in urinary and reproductive system symptoms such as frequent urination and urgency. In summary, the organs related to perimenopausal syndrome are mainly kidney deficiency, which affects the heart, liver, and spleen dysfunction. Therefore, the treatment should treat both the symptoms and the root causes, focusing on tonifying the kidney and replenishing the essence, regulating the liver and nourishing the blood, and at the same time nourishing the heart, strengthening the spleen, and soothing the liver.

[0004] Traditional Chinese medicine believes that kidney deficiency is the root cause of perimenopausal syndrome, and most of them are treated with kidney-tonifying drugs; modern medicine believes that ovarian function decline and reduced estrogen secretion are its core pathogenesis and pathological basis, and mainly adopts hormone replacement therapy, but this method is prone to adverse reactions such as increased incidence of estrogen-dependent malignant tumors, heart damage, and stroke, and its use is limited. However, Chinese medicine can relieve clinical symptoms without increasing the risk of malignant tumors, and is therefore widely recognized. Modern pharmacological research and clinical practice have confirmed that many kidney-tonifying Chinese medicines have estrogen-like effects, which can regulate endocrine and the function of the thalamus-pituitary-ovarian axis, thereby improving the symptoms of perimenopausal syndrome. Therefore, the selection of medicinal and edible products with the effects of nourishing the liver and kidney, nourishing the heart and calming the mind, and nourishing the spleen and stomach, to nourish the kidney while taking into account the heart, liver, and spleen, regulating the disorder of the internal organs, promoting the balance of yin and yang, and regulating the function of menstrual disorders, is highly safe, has no toxic side effects, is easy to carry and eat, and can significantly improve the symptoms of perimenopausal syndrome, so that the majority of women can smoothly pass the perimenopausal period. Summary of the invention

[0005] The purpose of the present invention is to make up for the deficiencies of the prior art and provide a Chinese medicine composition, which comprises, by weight ratio, 1 to 40 parts of Chinese date seeds, 1 to 40 parts of Poria cocos, 1 to 40 parts of Chinese yam, 1 to 30 parts of Chinese wolfberry, 1 to 30 parts of Polygonatum sibiricum, 1 to 30 parts of mulberry, 1 to 30 parts of raspberry, 1 to 20 parts of red peony flowers, 1 to 20 parts of double red roses, 1 to 10 parts of licorice, 1 to 10 parts of hops, and 1 to 10 parts of pine pollen. The composition of the present invention can be directly ground into powder, or it can be an extract prepared by conventional means in the art. The raw materials used in the composition of the present invention can also be used in the form of direct grinding into powder, extracts, or other processed forms.

[0006] Preferably, the composition comprises: 10-30 parts of Chinese jujube seeds, 10-30 parts of Poria cocos, 10-30 parts of Chinese yam, 5-20 parts of wolfberry, 5-20 parts of polygonatum, 1-15 parts of mulberry, 5-20 parts of raspberry, 1-10 parts of red peony flowers, 1-10 parts of double red roses, 1-5 parts of licorice, 1-5 parts of hops, and 2-10 parts of pine pollen.

[0007] Preferably, the composition comprises: 10-25 parts of Chinese jujube seeds, 10-25 parts of Poria cocos, 10-25 parts of Chinese yam, 5-15 parts of wolfberry, 5-15 parts of polygonatum, 5-15 parts of mulberry, 5-15 parts of raspberry, 1-10 parts of red peony flowers, 1-10 parts of double red roses, 1-5 parts of licorice, 1-5 parts of hops, and 5-10 parts of pine pollen.

[0008] More preferably, the composition comprises: 15-20 parts of Chinese jujube seeds, 15-20 parts of Poria cocos, 15-20 parts of Chinese yam, 10-15 parts of wolfberry, 10-15 parts of polygonatum, 10-15 parts of mulberry, 10-15 parts of raspberry, 5-10 parts of red peony flowers, 5-10 parts of double red roses, 1-3 parts of licorice, 1-3 parts of hops, and 5-10 parts of pine pollen.

[0009] Most preferably, the composition comprises: 20 parts of Chinese jujube seeds, 20 parts of Poria cocos, 20 parts of Chinese yam, 12 parts of wolfberry, 12 parts of polygonatum, 12 parts of mulberry, 12 parts of raspberry, 6 parts of red peony flowers, 6 parts of double red roses, 3 parts of licorice, 3 parts of hops, and 5 parts of pine pollen.

[0010] The present invention also proposes the use of any of the above-mentioned compositions in medicines, health products and foods for improving perimenopausal syndrome, for example, it can be used to regulate disordered hormone levels in the body and / or alleviate sexual organ (uterus) atrophy.

[0011] The composition of the present invention can be used to prepare medicines, health products and foods that nourish the liver and kidneys, regulate endocrine, improve ovarian microcirculation and resist aging.

[0012] The present invention also proposes the use of any of the above-mentioned compositions in the preparation of medicines, health products and foods for treating perimenopausal female symptoms including irritability, palpitations, hot flashes, insomnia and forgetfulness, menstrual disorders, frequent urination and the like.

[0013] Specifically, the use may be any method that is beneficial to improving the corresponding symptoms of the patient, including treatment or prevention.

[0014] The present invention also provides a composition, which is prepared from any of the above-mentioned compositions and an auxiliary material or additive acceptable to medicines, health products, and foods.

[0015] Specifically, the composition is selected from decoction, granules, capsules, tablets, oral liquids, pills, soft capsules, dripping pills, tinctures, syrups, suppositories, gels, sprays, and injections.

[0016] The present invention also provides a method for preparing any of the aforementioned compositions, the preparation method comprising:

[0017] Take Chinese date seeds, poria, Chinese yam, wolfberry, polygonatum, mulberry, raspberry, red peony flower, double red rose, and licorice medicinal materials, add 8 to 12 times water to reflux extraction, filter the extract, concentrate the filtrate to a relative density of 1.10 to 1.15, centrifuge and dry; take Humulus lupulus medicinal materials, add 8 to 12 times water to reflux extraction, filter the extract, concentrate the filtrate to a relative density of 1.05 to 1.10, dry the concentrated filtrate and mix it with the extract powder and pine pollen. Preferably, the preparation method of the composition comprises:

[0018] Take Chinese date seeds, Poria cocos, Chinese yam, Chinese wolfberry, Polygonatum sibiricum, mulberry, raspberry, red peony flower, double red rose, and licorice, add water and reflux extract twice, each time for 1 hour, add 12 times water for the first time, and add 10 times water for the second time, combine the extracts, filter, concentrate the filtrate to a ratio of 1:1 with the medicinal materials (relative density 1.10-1.15, 60°C), centrifuge and filter, spray dry the mixed solution to obtain extract powder①;

[0019] Take the herb of Humulus lupulus and add 8-12 times of water to reflux extraction, filter the extract, concentrate the filtrate to a relative density of 1.05-1.10, centrifuge and filter, and spray dry the filtrate;

[0020] Preferably, take the herb of Humulus lupulus and add water to reflux extraction twice, each time for 1 hour, add 12 times of water for the first time, and add 10 times of water for the second time, combine the extracts, filter, concentrate the filtrate to a ratio of 1:1 with the herb (relative density 1.05-1.10, 60°C), spray dry the filtrate to obtain extract powder②;

[0021] The extract powder ①, extract powder ② and pine pollen obtained after the above drying can be crushed and mixed as needed.

[0022] The invention also proposes a preparation method of a Chinese medicine granule, which comprises: taking 20 parts of Chinese jujube seeds, 20 parts of Poria cocos, 20 parts of Chinese yam, 12 parts of wolfberry, 12 parts of polygonatum, 12 parts of mulberry, 12 parts of raspberry, 6 parts of red peony flowers, 6 parts of double red roses, and 3 parts of liquorice, adding water to extract twice, each time for 1 hour, adding 12 times of water for the first time and 10 times of water for the second time, combining the extracts, filtering, concentrating the filtrate to a ratio of 1:1 with the medicinal materials (relative density 1.10-1.15, 60°C), centrifuging and filtering, adding 5%-15% maltodextrin to the filtrate, mixing evenly, spray drying, and obtaining extract powder①.

[0023] Take 3 parts of hops, add water to extract twice, each time for 1 hour, add 12 times of water for the first time, add 10 times of water for the second time, combine the extracts, filter, relative density 1.10-1.15, 60°C, centrifuge and filter, spray dry the filtrate to obtain extract powder ②. Grind and mix the obtained extract powder ①, extract powder ② and 5 parts of pine pollen to obtain an intermediate composition, add acerola fruit powder, maltodextrin and stevioside, and mix well to obtain.

[0024] The present invention proposes a Chinese medicine composition, and provides a preparation method of an active extract intermediate composition for preparing the composition. The composition obtained by the extraction method of the present invention, a composition for improving perimenopausal syndrome provided by the present invention, has the main effects of nourishing the kidney and replenishing essence, nourishing yin and suppressing yang, regulating yin and yang balance, regulating viscera disorders, improving ovarian microcirculation, delaying aging, and having obvious therapeutic effects on patients with perimenopausal syndrome, especially patients with liver and kidney yin deficiency type perimenopausal syndrome, and can improve many symptoms of perimenopausal women such as irritability, palpitations, hot flashes, anxiety and depression, insomnia, forgetfulness, frequent urination, etc. It has the effect of improving various symptoms of female perimenopause and regulating hormone levels, and has no toxic side effects. DETAILED DESCRIPTION

[0025] As mentioned above, the present invention aims to provide a Chinese medicine composition and its preparation method and application. The following will be described in detail in conjunction with the contents of the experimental examples.

[0026] It is particularly important to point out that similar substitutions and modifications made to the present invention are obvious to those skilled in the art, and they are all considered to be included in the present invention. Relevant personnel can obviously modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. The following are the raw materials of the Chinese medicine composition of the present invention:

[0027] Ziziphus jujuba seeds: This product is the dried mature seeds of Ziziphus jujuba Mill.var.spinosa (Bunge) Huex HFChou, a plant of the Rhamnaceae family. The mature fruits are harvested in late autumn and early winter, the pulp and shell are removed, the seeds are collected and dried. Poria cocos: This product is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. Chinese Yam: This product is the dried rhizome of Dioscorea opposita Thunb., a plant of the Dioscoreaceae family. Lycium barbarum: This product is the dried mature fruit of Lycium barbarum L., a plant of the Solanaceae family. Polygonatum sibiricum: This product is the dried rhizome of Polygonatum kingianum Coll.et Hemsl., Polygonatum sibiricum Red. or Polygonatum cyrtonema Hua, plants of the Liliaceae family. Mulberry: This product is the dried fruit spike of Morus alba L., a plant of the Moraceae family. Raspberry: This product is the dried fruit of Rubus chingii Hu, a plant of the Rosaceae family. Peony flower is a new food raw material, which is the dried flower of Peony flower, a plant of the Paeonia family, and has certain medicinal value. Double red rose: This product is the dried flower bud of Rosa rugosa Thunb., a plant of the Rosaceae family. Licorice: This product is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., a plant of the Leguminosae family. Hops: This product is Humulus lupulus L., a plant of the Moraceae family. The unripe green fruit spikes are used as medicine. The fruit spikes are picked when they are green and slightly yellow, and then dried in the sun or in an oven. Pine pollen: This product is the dried pollen of Pinus massoniana Lamb., Pinus tabulieformis Carr. or several plants of the same genus in the Pinaceae family.

[0028] If no specific conditions are specified in the present invention, the process is carried out under conventional conditions or conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments used, whose manufacturers are not specified, are all conventional products that can be obtained commercially.

[0029] Example 1 Chinese medicine compound granules

[0030] Prescription: 20 parts of spiny jujube seeds, 20 parts of Poria cocos, 20 parts of yam, 12 parts of wolfberry, 12 parts of polygonatum, 12 parts of mulberry, 12 parts of raspberry, 6 parts of red peony flowers, 6 parts of double red roses, 3 parts of liquorice, 3 parts of hops, and 5 parts of pine pollen.

[0031] The preparation method of the Chinese medicine composition granules:

[0032] Take Chinese date seeds, Poria cocos, Chinese yam, Chinese wolfberry, Polygonatum sibiricum, mulberry, raspberry, red peony flower, double red rose, and licorice medicinal materials, add 8-12 times water, reflux extraction, extract twice, each time for 1 hour, add 12 times water for the first time, and add 10 times water for the second time, combine the extracts, filter, concentrate the filtrate to a ratio of 1:1 with the medicinal materials (relative density 1.10-1.15, 60°C), centrifuge, concentrate the filtrate to a relative density of 1.10-1.15, centrifuge, add 5%-15% maltodextrin, mix evenly, spray dry, and obtain extract powder①;

[0033] Take the herb of Humulus lupulus and add 8-12 times of water to reflux extraction, filter the extract, concentrate the filtrate to a relative density of 1.05-1.10, centrifuge and filter, and spray dry the filtrate. Add water to the herb and reflux extract twice, each time for 1 hour, add 12 times of water for the first time, and add 10 times of water for the second time, combine the extracts, filter, concentrate the filtrate to a relative density of 1.05-1.10, centrifuge and filter, spray dry the filtrate to obtain extract powder②;

[0034] The extract powder ①, extract powder ② and pine pollen obtained above are crushed and mixed uniformly to obtain a Chinese medicine composition, and acerola fruit powder, maltodextrin and stevioside are added to obtain granules by dry granulation.

[0035] Embodiment 2 Chinese medicine compound capsule

[0036] Prescription: 10 parts of spiny jujube seeds, 20 parts of Poria cocos, 15 parts of yam, 15 parts of wolfberry, 10 parts of polygonatum, 5 parts of mulberry, 15 parts of raspberry, 8 parts of red peony flowers, 2 parts of double red rose, 3 parts of liquorice, 3 parts of hops, and 7 parts of pine pollen.

[0037] The preparation method of the Chinese medicine composition capsule:

[0038] Take Chinese jujube seeds, Poria cocos, Chinese yam, Chinese wolfberry, Polygonatum sibiricum, mulberry, raspberry, red peony flower, double red rose, and licorice medicinal materials, add 8-12 times water, reflux extraction, extract twice, each time for 1 hour, add 12 times water for the first time, and add 10 times water for the second time, combine the extracts, filter, concentrate the filtrate to a ratio of 1:1 with the medicinal materials (relative density 1.10-1.15, 60°C), centrifuge and filter, concentrate the filtrate to a relative density of 1.10-1.15, centrifuge and filter, add 5%-15% maltodextrin, mix evenly, spray dry, and obtain extract powder①.

[0039] Take the herb of Humulus lupulus and add 8-12 times of water to reflux extraction, filter the extract, concentrate the filtrate to a relative density of 1.05-1.10, centrifuge and filter, and spray dry the filtrate. Add water to the herb and reflux extract twice, each time for 1 hour, add 12 times of water for the first time, and add 10 times of water for the second time, combine the extracts, filter, concentrate the filtrate to a relative density of 1.05-1.10, centrifuge and filter, spray dry the filtrate to obtain extract powder②,

[0040] The extract powder ①, extract powder ② and pine pollen obtained above are crushed and mixed evenly to obtain a Chinese medicine composition, and certain auxiliary materials are added to wet granulate to prepare capsules.

[0041] Example 3 Chinese medicine compound tablets

[0042] Prescription: 20 parts of Chinese jujube seeds, 25 parts of Poria cocos, 20 parts of Chinese yam, 10 parts of wolfberry, 5 parts of polygonatum, 5 parts of mulberry, 15 parts of raspberry, 5 parts of red peony flowers, 5 parts of double red roses, 2 parts of liquorice, 2 parts of hops, and 3 parts of pine pollen.

[0043] The preparation method of the Chinese medicine composition tablet:

[0044] Take Chinese jujube seeds, Poria cocos, Chinese yam, Chinese wolfberry, Polygonatum sibiricum, mulberry, raspberry, red peony flower, double red rose, and licorice medicinal materials, add 8-12 times water, reflux extraction, extract twice, each time for 1 hour, add 12 times water for the first time, and add 10 times water for the second time, combine the extracts, filter, concentrate the filtrate to a ratio of 1:1 with the medicinal materials (relative density 1.10-1.15, 60°C), centrifuge and filter, concentrate the filtrate to a relative density of 1.10-1.15, centrifuge and filter, add 5%-15% maltodextrin, mix evenly, spray dry, and obtain extract powder①.

[0045] Take the herb of Humulus lupulus and add 8-12 times of water to reflux extraction, filter the extract, concentrate the filtrate to a relative density of 1.05-1.10, centrifuge and filter, and spray dry the filtrate. Add water to the herb and reflux extract twice, each time for 1 hour, add 12 times of water for the first time, and add 10 times of water for the second time, combine the extracts, filter, concentrate the filtrate to a relative density of 1.05-1.10, centrifuge and filter, spray dry the filtrate to obtain extract powder②,

[0046] The extract powder ①, extract powder ② and pine pollen obtained above are crushed and mixed evenly to obtain a Chinese medicine composition, and auxiliary materials such as maltodextrin and microcrystalline cellulose are added to prepare tablets.

[0047] Example 4 Effect of the composition of the present invention on changes in body weight and uterine index, serum hormone E2, FSH, and LH levels in perimenopausal castrated rats

[0048] 1 Materials and methods

[0049] 1.1 Materials

[0050] 1.1.1 Experimental animals

[0051] SPF rats, 36 females, weighing 220 g ± 20, license number SCXK (Su) 2019-0001, were provided by the Experimental Animal Center of Nantong University. During the experiment, they were caged in the same room, with 12 h of light and 12 h of darkness, and had free access to water and feed. The room temperature was 18-22 °C.

[0052] 1.1.2 Experimental drugs

[0053] Test drug: The low, medium and high doses of the Chinese medicine composition prepared in Example 1 are 0.18g / kg (raw drug amount 0.41g / kg), 0.36g / kg (raw drug amount 0.82g / kg), 0.72g / kg (raw drug amount 1.64g / kg) (each administration volume 10mL / kg), preparation method: dissolve in distilled water, respectively configured to concentrations of 0.18g / mL, 0.36 / mL, 0.72g / mL, and set aside. Positive drug group: The dosage of estradiol valerate tablets is 0.2mg / kg.

[0054] 1.2 Experimental methods

[0055] 1.2.1 Modeling and administration: SPF rats, female, were randomly divided into 6 groups according to body weight, namely normal control group, model control group, positive control group (estradiol valerate 0.2mg / kg), low-dose group of Chinese medicine composition (0.18g / kg), medium-dose group of Chinese medicine composition (0.36g / kg), and high-dose group of Chinese medicine composition (0.72g / kg), with 6 rats in each group. Except for the normal control group, the rats in the other groups were anesthetized by intraperitoneal injection of 3.5% chloral hydrate solution 10ml / kg, and the skin and muscles were cut under the back ribs to expose the abdominal cavity, and the bilateral ovaries were found. Both ovaries were removed and sutured. A certain amount of penicillin was injected intramuscularly every day for the first three days after the operation to prevent infection and death. After the modeling was successful, except for the normal control group and the model control group, which were gavaged with a volume of 1mL / 100g distilled water according to body weight, each medication group was gavaged with the corresponding drug, and the gavage volume was 1mL / 100g body weight, once a day for 1 month. After the experiment, the rats were anesthetized and blood was collected. The serum was separated and the hormone content was detected using a kit; the uterus was separated and weighed, and the uterine index was calculated.

[0056] 1.2.2 Index determination

[0057] ① Serum sex hormone index: Blood was collected from the eye sockets two months after administration to measure serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) levels. ② Organ index: After the rats were killed, the abdominal cavity was opened, the uterus was taken out, the wet weight was weighed, and the uterine index was calculated. ③ Statistical analysis: All data results were expressed as mean ± standard deviation, and the t-test was performed between groups to compare the means of two samples. P < 0.05 was considered statistically significant.

[0058] 2 Experimental results

[0059] Table 1 Changes in uterine weight and uterine index of rats in each group (±s, n=6)

[0060]

[0061]

[0062] Note: Compared with the normal control group, a) p < 0.05; compared with the model control group, b) p < 0.05; compared with the positive group, c) p < 0.05.

[0063] As shown in Table 1, compared with the normal control group, the uterine weight and uterine index of the rats in the model control group, positive drug group, experimental low-, medium- and high-dose groups were significantly reduced after ovariectomy, among which the uterine weight and uterine index of the rats in the model control group were the lowest; compared with the model control group, the uterine weight and coefficient of the rats in the positive drug group, experimental low-, medium- and high-dose groups were significantly increased; among which the uterine weight and coefficient of the rats in the experimental high-dose group were even higher than those in the positive control group.

[0064] Table 2 Changes in serum hormone levels in rats of each group (±s, n=6)

[0065]

[0066] Note: Compared with the normal control group, a) p < 0.05; compared with the model control group, b) p < 0.05; compared with the positive group, c) p < 0.05.

[0067] The results are shown in Table 2: Compared with the normal control group, the serum E2 level of the rats in the model control group was significantly reduced, and the LH and FSH levels were significantly increased, which indicated that the rat modeling was successful. Compared with the model control group, the low, medium and high doses (0.18 g / kg, 0.36 g / kg, 0.72 g / kg) of the pharmaceutical composition of Example 1 can significantly increase the serum E2 level of the model rats and reduce the LH and FSH levels of the model rats.

[0068] This study shows that the drug composition of this embodiment can increase the estrogen level of the classic perimenopausal model animals, regulate the disordered hormone levels in the body, and alleviate the atrophy of sexual organs, with significant differences compared with the model control group. This indicates that this drug composition has a certain improvement effect on the perimenopausal rat model and can be developed into a new indication for the treatment of perimenopausal syndrome.

[0069] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A composition for improving perimenopausal syndrome, characterized in that: In terms of weight ratio, the Chinese medicine composition comprises: 1-40 parts of sour jujube seeds, 1-40 parts of poria cocos, 1-40 parts of yam, 1-30 parts of wolfberry, 1-30 parts of polygonatum, 1-30 parts of mulberry, 1-30 parts of raspberry, 1-20 parts of red peony flowers, 1-20 parts of double red roses, 1-10 parts of liquorice, 1-10 parts of hops, and 1-10 parts of pine pollen.

2. The composition according to claim 1, characterized in that The Chinese medicine composition comprises: 10-25 parts of sour jujube seeds, 10-25 parts of poria cocos, 10-25 parts of yam, 10-15 parts of wolfberry, 5-15 parts of polygonatum, 5-15 parts of mulberry, 5-15 parts of raspberry, 1-10 parts of red peony flowers, 1-10 parts of double red roses, 1-5 parts of liquorice, 1-5 parts of hops, and 5-10 parts of pine pollen.

3. The composition according to claim 1, characterized in that The Chinese medicine composition comprises: 15-20 parts of sour jujube seeds, 15-20 parts of poria cocos, 15-20 parts of yam, 10-15 parts of wolfberry, 10-15 parts of polygonatum, 10-15 parts of mulberry, 10-15 parts of raspberry, 5-10 parts of red peony flowers, 5-10 parts of double red roses, 1-3 parts of liquorice, 1-3 parts of hops, and 5-10 parts of pine pollen.

4. The composition according to claim 1, characterized in that The Chinese medicine composition comprises: 20 parts of Semen Ziziphi Spinosae, 20 parts of Poria cocos, 20 parts of Rhizoma Dioscoreae, 12 parts of Fructus Lycii, 12 parts of Rhizoma Polygonati, 12 parts of Fructus Mori, 12 parts of Fructus Rubi, 6 parts of Red Peony Flowers, 6 parts of Double Red Roses, 3 parts of Radix Glycyrrhizae, 3 parts of Herba Humuli, and 5 parts of Pine Pollen.

5. Use of the composition according to any one of claims 1 to 4 in the preparation of medicines, health products or foods for improving perimenopausal syndrome.

6. Use of the composition according to any one of claims 1 to 4 in the preparation of medicines, health products or foods for regulating disordered hormone levels in the body and alleviating sexual organ atrophy.

7. A medicine, health product or food, characterized in that: The invention comprises the composition according to any one of claims 1 to 4 and acceptable auxiliary materials or additives.

8. The medicine, health product or food according to claim 7, characterized in that: The medicine, health product or food is selected from decoction, granules, capsules, tablets, pills, oral liquids, tinctures, syrups, suppositories, gels, sprays and injections.

9. A method for preparing the composition according to any one of claims 1 to 4, characterized in that: The composition preparation method comprises: The Chinese medicinal materials of spiny jujube seeds, poria cocos, yam, wolfberry, polygonatum, mulberry, raspberry, red peony flower, double red rose and licorice are added with 8-12 times of water for reflux extraction, the extract is filtered, the filtrate is concentrated and dried to obtain extract powder; the Chinese medicinal material of Humulus lupulus is added with 8-12 times of water for reflux extraction, the extract is filtered, the filtrate is concentrated to a relative density of 1.05-1.10, and the concentrated filtrate is dried and mixed with the extract powder and pine pollen.

10. A method for preparing a medicine, health product or food according to claim 7 or 8, characterized in that: The medicine, health product or food is selected from granules, and the preparation method thereof comprises: taking Chinese date seeds, poria, yam, wolfberry, polygonatum, mulberry, raspberry, red peony flower, double red rose and liquorice medicinal materials, adding water and refluxing extraction for 2 times, each time for 1 hour, adding 12 times water for the first time and 10 times water for the second time, combining the extracts, filtering, concentrating the filtrate to a relative density of 1.10-1.15, centrifugally filtering, adding 5%-15% maltodextrin, spray drying, and obtaining extract powder ①; taking Humulus lupulus medicinal materials, adding 8-12 times water and refluxing extraction, filtering the extract, concentrating the filtrate to a relative density of 1.05-1.10, centrifugally filtering, spray drying the concentrated filtrate, and obtaining extract powder ②; mixing the obtained extract powder ①, extract powder ② and pine pollen evenly to obtain an intermediate composition, adding acerola fruit powder, maltodextrin and stevioside, mixing evenly and granulating.

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