Traditional Chinese medicine formula granules for treating perimenopausal female sleep disorder and preparation method of traditional Chinese medicine formula granules

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to traditional Chinese medicine formula granules for treating perimenopausal female sleep disorder and a preparation method thereof. The traditional Chinese medicine formula granules are prepared from the following raw materials in parts by weight: 3 to 5 parts of nacre mother of pearl, 8 to 10 parts of raw oyster, 3 to 5 parts of semen boitae, 3 to 4 parts of honey-fried licorice root, 3 to 5 parts of glossy privet fruit, 3 to 5 parts of herba ecliptae, 3 to 5 parts of raw spina date seed, 8 to 10 parts of tortoise shell, 8 to 10 parts of radix salviae miltiorrhizae and 3 to 5 parts of radix angelicae sinensis. According to the traditional Chinese medicine formula granules, kidney tonifying, blood activating and heart and kidney traffic are effectively fused, and the effects of lightly dispersing pathogenic qi of intangible deficiency heat and expelling tangible and gummy blood stasis are effectively combined. In combination with the physiological characteristics of seven-seven women, water-fire balance of heart and kidney is regulated, and yin-yang harmony of mind is relieved; in addition, the preparation method is simple and easy to control, and large-scale production is facilitated; and finally, the medicine prepared by the invention is granules, is convenient to take after being mixed with water, and can benefit more female patients.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine formula granule for treating sleep disorders in perimenopausal women and a preparation method thereof. Background Art

[0002] Perimenopausal syndrome, often referred to as menopausal syndrome, is a series of physical signs and psychological symptoms caused by women before and after entering menopause, such as palpitations, hot flashes, anxiety, dry mouth, etc., which are rooted in the fluctuation and reduction of sex hormones. Menopause can be divided into natural menopause, that is, the decline of follicular function leads to permanent cessation of menstruation; and artificial menopause, including surgical removal of the ovaries or iatrogenic operations leading to loss of ovarian function. Among them, women with artificial menopause are more likely to experience menopausal symptoms. The exact time of perimenopause varies slightly due to individual differences, but generally starts at around 40 years old, which is the beginning of ovarian function decline, and lasts for about 1 year after the last menstruation.

[0003] Patent No. 201410537766.3 discloses a Chinese medicine composition for regulating menopausal syndrome, the raw materials of which include: Polygonum multiflorum, Ligustrum lucidum, Kudingcha, Albizzia julibrissin, Lycium barbarum leaf, Chrysanthemum, Eucommia ulmoides, Cuscuta australis, Tangerine peel, Cortex Moutan, Ecliptae, Angelica sinensis and Ophiopogon japonicus. This solution is not very targeted, and contains Polygonum multiflorum, which is toxic to the liver and kidneys.

[0004] Therefore, based on this, the technical solution of the present invention is proposed. Summary of the invention

[0005] In order to solve the problems existing in the prior art, the present invention provides a Chinese medicine formula granule for treating sleep disorders in perimenopausal women. The Chinese medicine formula granule comprises the following raw materials in parts by weight: 3-5 parts of mother of pearl, 8-10 parts of raw oyster, 3-5 parts of cypress seed, 3-4 parts of roasted licorice, 3-5 parts of Ligustrum lucidum fruit, 3-5 parts of Eclipta prostrata, 3-5 parts of raw Ziziphus jujuba seed, 8-10 parts of tortoise shell, 8-10 parts of Salvia miltiorrhiza, and 3-5 parts of Angelica sinensis.

[0006] Preferably, the Chinese medicine formula granules include the following raw materials in parts by weight: 5 parts of mother of pearl, 10 parts of raw oyster, 5 parts of cypress seed, 3.3 parts of roasted licorice, 5 parts of Ligustrum lucidum, 5 parts of Eclipta prostrata, 5 parts of raw Ziziphus jujuba seed, 10 parts of tortoise shell, 10 parts of Salvia miltiorrhiza, and 5 parts of Angelica sinensis.

[0007] Based on the same technical concept, the present invention further provides a method for preparing Chinese medicine formula granules for treating sleep disorders in perimenopausal women, the preparation method comprising the following steps:

[0008] (1) mixing mother-of-pearl, raw oysters, tortoise shells and water and boiling them, and filtering to obtain a mother-of-pearl-raw oyster-tortoise shell boiling filtrate;

[0009] (2) adding pine nuts, roasted liquorice, Ligustrum lucidum fruit, Eclipta prostrata, and raw Ziziphus jujuba seeds into ethanol for ultrasonic extraction, and filtering to obtain a filter residue and an extract;

[0010] (3) combining the extracts of the respective components in step (2) to obtain a total extract; and then concentrating the total extract until there is no alcohol taste to obtain a concentrated solution;

[0011] (4) combining the filter residues of the respective components in step (2) to obtain a total filter residue; and then boiling the total filter residue with water to obtain a total decoction;

[0012] (5) mixing salvia miltiorrhiza and angelica sinensis with water and decocting the mixture, and filtering the mixture to obtain a salvia miltiorrhiza-angelica sinensis decoction filtrate;

[0013] (6) combining the pearl mother-oyster-tortoise shell decoction filtrate obtained in step (1), the concentrated solution obtained in step (3), the total decoction obtained in step (4), and the salvia miltiorrhiza-angelica decoction filtrate obtained in step (5), and concentrating the mixture by rotary evaporation to a paste to obtain an extract, and then drying, crushing, and sieving the extract to obtain an extract powder;

[0014] (7) uniformly mixing the extract with the mixed auxiliary materials, and then adding ethanol to prepare a soft material;

[0015] (8) The soft material is granulated and dried in sequence to obtain Chinese medicine formula granules for treating sleep disorders in perimenopausal women.

[0016] Preferably, in step (1), the mother-of-pearl, raw oyster and tortoise shell are mixed with 18 to 22 times of water and boiled, kept in a boiling state for 2 to 3 hours, and then filtered to obtain a filter residue and a primary filtrate; the filter residue is then boiled with water of the same mass and filtered to obtain a secondary filtrate; the primary filtrate and the secondary filtrate are combined; the above steps are boiled for a total of 3 times, and all the filtrates are combined to obtain the mother-of-pearl-raw oyster-tortoise shell decoction filtrate.

[0017] Preferably, in step (2), the seeds of Platycladus orientalis, roasted licorice, fructus ligustri lucidi, herba Ecliptae, and raw jujube seeds are added to aqueous ethanol solutions with volume concentrations of 90%, 60%, and 30%, respectively, and ultrasonic-assisted extraction is performed for 30 to 35 minutes at an ultrasonic power of 100 to 120 W and a temperature of 50 to 55° C. After completion, the extraction is filtered to obtain a residue and an extract.

[0018] Preferably, in step (4), the filter residues of the respective components in step (2) are combined to obtain a total filter residue; and the total filter residue is then boiled in water for 3 to 4 times to obtain a total decoction.

[0019] Preferably, in step (5), Danshen and Angelica are mixed with 12 to 14 times the mass of water and decocted for 3 to 4 times, with each decoction time being 1.5 to 2 hours. After completion, the mixture is filtered and combined to obtain a Danshen-Angelica decoction filtrate.

[0020] Preferably, in step (6), the extract is concentrated by rotary evaporation under reduced pressure at 70°C, and the relative density of the extract is 1.12; and / or the drying method is: drying under reduced pressure at 70°C.

[0021] Preferably, in step (7), the mass ratio of the extract to the mixed excipient is 2:1; and / or the mixed excipient includes microcrystalline cellulose and mannitol, and the mass ratio of the microcrystalline cellulose to the mannitol is 1:1; and / or the ethanol is an ethanol aqueous solution with a volume fraction of 85%, and the mass of the ethanol aqueous solution is 25% of the mass of the soft material.

[0022] Preferably, in step (8), the soft material is extruded and passed through a 16-mesh sieve to obtain wet granules, and then the wet granules are placed in a drying oven at 60° C. to dry, and after completion, they are sized through a 14-mesh sieve to obtain Chinese medicine formula granules for treating sleep disorders in perimenopausal women.

[0023] For ease of understanding of the present invention, the compatibility of the present invention is described:

[0024] Salvia miltiorrhiza 30g, Angelica sinensis 15g, both are the main drugs (nourishing blood and promoting blood circulation). Ligustrum lucidum 15g, Eclipta prostrata 15g, Tortoise shell 30g (nourishing liver and kidney); Raw Ziziphus jujuba seeds 15g, Platycladus orientalis seeds 15g (calming the mind and tranquilizing the nerves); Raw oyster 30g, Mother of pearl 15g (calming the nerves and tranquilizing the nerves); three groups of ministerial drugs. Roasted Licorice root 10g (adjuvant drug).

[0025] The results of modern pharmacological research show that Danshen mainly contains tanshinone and tanshinone components, which have pharmacological effects such as protecting the cardiovascular system, anti-inflammatory, anti-oxidation, and scavenging free radicals; Angelica sinensis mainly contains volatile oils and organic acids, which have pharmacological effects such as improving cardiovascular and cerebrovascular diseases, enhancing the body's hematopoietic function, and improving the body's immune system. The "Zhu's Gynecological Medicine Pairs and Medicine Groups" edited by the clinical master of traditional Chinese medicine Zhu Nansun details the compatibility of Danshen and Angelica sinensis, which has the effects of nourishing blood and activating blood circulation, and can be used to treat blood stasis and blood deficiency. Professor Ma Kun used this drug pair in clinical practice to treat insomnia from the perspective of activating blood circulation and removing blood stasis, with remarkable results.

[0026] Erzhi Pills, which are composed of Ligustrum lucidum and Ecliptae, are derived from the Medical Prescriptions Collection. Ligustrum lucidum is cool in nature, sweet and bitter in taste, and belongs to the liver and kidney meridians. It has the effects of nourishing liver and kidney yin, blackening the beard and improving eyesight, and is characterized by nourishing the liver and kidney, nourishing essence and nourishing blood; Ecliptae is cold in nature, sweet and sour in taste, and can adjust yin and yang, achieve the effect of cooling blood and stopping bleeding. The combined use can achieve the effect of nourishing the liver and kidney, strengthening tendons and bones, and removing deficiency heat. Its formula embodies the "nourishing water and containing wood" method. The combination of tortoise shell, which nourishes yin and suppresses yang, benefits the kidney and strengthens bones, nourishes blood and nourishes the heart, plays the role of nourishing the liver and kidney, nourishing the heart and cooling blood.

[0027] Raw sour jujube seeds and cypress seeds are used together. "Sour jujube seeds are sweet in taste and enter the liver and heart meridians. They can nourish liver blood and benefit heart yin to achieve the effect of calming the mind. They are important medicines for nourishing the heart and calming the mind. They are especially suitable for those with insufficient heart and liver yin and blood, and those who are not nourished by the mind and have palpitations, dreams, and insomnia due to deficiency. "Yaojian" records that "Sour jujube seeds have a flat qi, sweet and sour taste, and are non-toxic. They can calm the five internal organs and greatly nourish the heart and spleen." "Yaoyao Huayi" also says: "Zijube seeds, the main tonic, the red skin is similar to the heart, and they are used to benefit the heart blood. Its qi is fried and fragrant, and it becomes slightly warm. The fragrance can penetrate the heart qi, and the warmth can help the mind. All those who are bitter in their minds will hurt the blood, and those who use their wisdom will damage the mind, resulting in heart deficiency... must use it. Also take the fragrance and warmth to warm the liver and gallbladder... Use this to make the liver and gallbladder blood sufficient, then the five internal organs will be harmonious, and sleep will be peaceful. "Sour jujube seeds can be widely used in the treatment of insomnia due to deficiency syndrome. Modern research has found that sour jujube seeds have the functions of hypnosis and sedation, anticonvulsant, analgesia, anti-anxiety, antidepression, improvement of cognition and regulation of immunity. In this study, the frequency of use of cypress seeds was second only to sour jujube seeds. It tastes sweet, is neutral in nature, and enters the heart, kidney and large intestine meridians, and has the effect of nourishing the heart and calming the mind. The heart is the master of storing the spirit, and the kidney stores the will. If both the heart and kidney are deficient, the mind will be restless, and there will be palpitations and insomnia. Cypress seeds enter the heart meridian to nourish the spirit, and enter the kidney meridian to calm the will. When the heart and kidney are nourished, the heart will be calm and the mind will be stable. "Compendium of Materia Medica" says: "Cypress seeds are neutral in nature and neither cold nor dry, sweet and tonic... nourish the heart qi, moisten the kidney dryness, calm the soul and stabilize the spirit, improve intelligence and calm the mind. "Modern pharmacological research has found that cypress seeds contain lipids, saponins, amino acids and other ingredients, which have the effects of calming the nerves, improving sleep, anti-depression, and improving memory storage disorders. The combination of Chinese jujube seeds and cypress seeds is complementary to each other and can enhance the function of nourishing the heart and calming the mind. It is suitable for insomnia, palpitations, and night sweats caused by yin and blood deficiency and lack of nourishment to the mind. Pharmacological studies have shown that both Chinese jujube seeds and cypress seeds can treat insomnia through multiple components, multiple pathways, multiple targets and multiple organs. The combination can superimpose sedative and hypnotic effects to achieve complementary therapeutic effects.

[0028] Raw oysters and mother-of-pearl are used together. Oysters belong to the liver and kidney meridians and have the functions of calming the liver and suppressing yang, astringing and firming, softening and dispersing lumps, calming the nerves and tranquilizing the mind. They are clinically used for palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm nodules, and masses. Mother-of-pearl has the functions of calming the liver and suppressing yang, clearing the liver and improving eyesight, calming the mind and tranquilizing the mind. They are clinically commonly used for the treatment of headache, dizziness, irritability, insomnia, liver-heat red eyes, liver-deficiency blurred vision, etc. The two drugs are used together to calm the nerves and tranquilize the mind.

[0029] Three groups of drug pairs are used in combination, the main drugs nourish blood and promote blood circulation, and the three pairs of auxiliary drugs nourish the liver and kidney, calm the mind and soothe the nerves; it is used to treat sleep disorders in perimenopausal women with various syndromes, such as: liver and kidney yin deficiency syndrome, restless syndrome, liver fire disturbance syndrome, kidney deficiency and blood stasis syndrome.

[0030] The beneficial effects of the present invention are:

[0031] 1. The Chinese medicine formula granules for treating sleep disorders in perimenopausal women of the present invention have scientific and reasonable raw material compatibility, no toxic side effects and excellent effects. Specifically, the inventors have found that mother-of-pearl can calm the heart, liver and kidney meridians, calm the nerves, soothe the liver and suppress yang, and can be used in combination with oysters to treat insomnia. Mother-of-pearl and oysters can significantly increase the content of 5-HT, 5-HIAA and GABA in the brainstem of mice and improve the sleep quality of insomnia mice. Ligustrum lucidum and Eclipta prostrata are used in Erzhi Pills, which nourish kidney yin and replenish kidney water; Salvia miltiorrhiza and Chinese angelica nourish blood and activate blood circulation, remove blood stasis and promote new blood circulation; Salvia miltiorrhiza can also clear the heart and relieve restlessness, and Platycladus seed replenishes qi and relieves restlessness, and Ziziphus jujuba seed nourishes the heart, calms the mind and stops sweating, and together with licorice, it forms Ganmai Dazao Tang, which can relieve women's restlessness and insomnia. The whole prescription replenishes kidney essence to adjust the kidney-Tiangui-Chongren-uterus axis, and at the same time promotes blood circulation and menstruation to eliminate evil and treat symptoms, so that the evil is gone and the body is at peace, thereby improving sleep problems caused by the rapid decline of estrogen in perimenopause. It effectively integrates kidney tonification and blood circulation with the communication between the heart and kidney, and effectively combines the dispersal of invisible evil qi of virtual heat with the expulsion of visible blood stasis. Combined with the physiological characteristics of women's "Qiqi", it adjusts the water and fire balance of the heart and kidney, and the harmony of yin and yang of the mind.

[0032] 2. The preparation method of the present invention is simple and easy to control, and is convenient for large-scale production.

[0033] 3. The medicine prepared by the present invention is a granule, which is convenient to prepare and take, and can benefit more female patients. DETAILED DESCRIPTION

[0034] To make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be described in detail below. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other implementation methods obtained by ordinary technicians in this field without creative work belong to the scope of protection of the present invention.

[0035] Example 1

[0036] This embodiment provides a method for preparing Chinese medicine formula granules for treating sleep disorders in perimenopausal women, the preparation method comprising the following steps:

[0037] (1) Mix 5 parts (1 part is about 3 g, the same below) of mother-of-pearl, 10 parts of raw oysters, and 10 parts of tortoise shells with 20 times of water and boil them, keep boiling for 2 hours, and then filter to obtain a filter residue and a primary filtrate; then add the same amount of water to the filter residue, boil it, and filter it to obtain a secondary filtrate; combine the primary filtrate and the secondary filtrate; boil it three times according to the above steps, and combine all the filtrates to obtain a mother-of-pearl-raw oyster-tortoise shell decoction filtrate;

[0038] (2) 5 parts of pine nuts, 3.3 parts of roasted liquorice, 5 parts of Ligustrum lucidum, 5 parts of Eclipta prostrata, and 5 parts of Ziziphus jujuba seeds were added to ethanol aqueous solutions with volume concentrations of 90%, 60%, and 30% in sequence, and ultrasonic-assisted extraction was performed at an ultrasonic power of 100 W and a temperature of 50° C. for 30 minutes. After completion, filtering was performed to obtain a filter residue and an extract;

[0039] (3) combining the extracts of the respective components in step (2) to obtain a total extract; and then concentrating the total extract until there is no alcohol taste to obtain a concentrated solution;

[0040] (4) combining the filter residues of the respective components in step (2) to obtain a total filter residue; and then boiling the total filter residue with water for three times to obtain a total decoction;

[0041] (5) Mix 10 parts of Danshen and 4 parts of Angelica with 12 times the weight of water and decoct for 3 times, each decoction time is 1.5 hours. After completion, filter and combine to obtain the Danshen-Angelica decoction filtrate;

[0042] (6) combining the pearl mother-oyster-tortoise shell decoction filtrate obtained in step (1), the concentrated solution obtained in step (3), the total decoction obtained in step (4), and the salvia miltiorrhiza-angelica decoction filtrate obtained in step (5), and concentrating them by rotary evaporation to a paste to obtain an extract with a relative density of 1.12, and then drying the extract (drying under reduced pressure at 70° C.), crushing, and sieving to obtain an extract powder;

[0043] (7) uniformly mixing the extract powder with microcrystalline cellulose and mannitol, and then adding ethanol to prepare a soft material; wherein: the total mass of the microcrystalline cellulose and mannitol is the same as the mass of the extract powder, the mass ratio of the microcrystalline cellulose to the mannitol is 2:1, the ethanol is an ethanol aqueous solution with a volume fraction of 85%, and the mass of the ethanol aqueous solution is 25% of the mass of the soft material;

[0044] (8) The soft material is extruded and passed through a 16-mesh sieve to obtain wet granules, and then the wet granules are placed in a drying oven at 60° C. and dried under reduced pressure. After completion, the wet granules are sized through a 14-mesh sieve to obtain Chinese medicine formula granules for treating sleep disorders in perimenopausal women.

[0045] Example 2

[0046] This embodiment provides a method for preparing Chinese medicine formula granules for treating sleep disorders in perimenopausal women, the preparation method comprising the following steps:

[0047] (1) Mix 5 parts (1 part is about 3 g, the same below) of mother-of-pearl, 10 parts of raw oysters, and 10 parts of tortoise shells with 18 times of water and boil them, keep boiling for 2 hours, and then filter to obtain a filter residue and a primary filtrate; then add the same amount of water to the filter residue and boil it, and filter to obtain a secondary filtrate; combine the primary filtrate and the secondary filtrate; boil it three times according to the above steps, and combine all the filtrates to obtain a mother-of-pearl-raw oyster-tortoise shell decoction filtrate;

[0048] (2) 5 parts of pine nuts, 3.3 parts of roasted licorice, 5 parts of Ligustrum lucidum, 5 parts of Eclipta prostrata, and 5 parts of Ziziphus jujuba seeds were added to ethanol aqueous solutions with volume concentrations of 90%, 60%, and 30% in sequence, and ultrasonic-assisted extraction was performed at an ultrasonic power of 110 W and a temperature of 52° C. for 32 minutes. After completion, filtering was performed to obtain a filter residue and an extract;

[0049] (3) combining the extracts of the respective components in step (2) to obtain a total extract; and then concentrating the total extract until there is no alcohol taste to obtain a concentrated solution;

[0050] (4) combining the filter residues of the respective components in step (2) to obtain a total filter residue; and then boiling the total filter residue with water for three times to obtain a total decoction;

[0051] (5) Mix 10 parts of Danshen and 5 parts of Angelica with 13 times the weight of water and decoct for 3 times, each decoction time is 1.5 hours. After completion, filter and combine to obtain the Danshen-Angelica decoction filtrate;

[0052] (6) combining the pearl mother-oyster-tortoise shell decoction filtrate obtained in step (1), the concentrated solution obtained in step (3), the total decoction obtained in step (4), and the salvia miltiorrhiza-angelica decoction filtrate obtained in step (5), and concentrating them by rotary evaporation to a paste to obtain an extract with a relative density of 1.12, and then drying the extract (drying under reduced pressure at 70° C.), crushing, and sieving to obtain an extract powder;

[0053] (7) uniformly mixing the extract powder with microcrystalline cellulose and mannitol, and then adding ethanol to prepare a soft material; wherein: the total mass of the microcrystalline cellulose and mannitol is the same as the mass of the extract powder, the mass ratio of the microcrystalline cellulose to the mannitol is 2:1, the ethanol is an ethanol aqueous solution with a volume fraction of 85%, and the mass of the ethanol aqueous solution is 25% of the mass of the soft material;

[0054] (8) The soft material is extruded and passed through a 16-mesh sieve to obtain wet granules, and then the wet granules are placed in a drying oven at 60° C. and dried under reduced pressure. After completion, the wet granules are sized through a 14-mesh sieve to obtain Chinese medicine formula granules for treating sleep disorders in perimenopausal women.

[0055] Example 3

[0056] This embodiment provides a method for preparing Chinese medicine formula granules for treating sleep disorders in perimenopausal women, the preparation method comprising the following steps:

[0057] (1) Mix 5 parts of mother-of-pearl, 10 parts of raw oysters, and 10 parts of tortoise shells (1 part is about 3 g, the same below) with 22 times of water and boil them, keep boiling for 3 hours, and then filter to obtain a filter residue and a primary filtrate; then add the same amount of water to the filter residue and boil it, and filter to obtain a secondary filtrate; combine the primary filtrate and the secondary filtrate; boil them three times according to the above steps, and combine all the filtrates to obtain a mother-of-pearl-raw oyster-tortoise shell decoction filtrate;

[0058] (2) 5 parts of pine nuts, 3.3 parts of roasted licorice, 5 parts of Ligustrum lucidum, 5 parts of Eclipta prostrata, and 5 parts of Ziziphus jujuba seeds were added to ethanol aqueous solutions with volume concentrations of 90%, 60%, and 30% in sequence, and ultrasonic-assisted extraction was performed for 35 minutes under the conditions of ultrasonic power of 120 W and temperature of 55° C. After completion, filtering was performed to obtain a filter residue and an extract;

[0059] (3) combining the extracts of the respective components in step (2) to obtain a total extract; and then concentrating the total extract until there is no alcohol taste to obtain a concentrated solution;

[0060] (4) combining the filter residues of the respective components in step (2) to obtain a total filter residue; and then boiling the total filter residue with water for 4 times to obtain a total decoction;

[0061] (5) Mix 10 parts of Danshen and 5 parts of Angelica with 14 times the mass of water and decoct them 4 times, each decoction time is 2 hours. After completion, filter and combine to obtain the Danshen-Angelica decoction filtrate;

[0062] (6) combining the pearl mother-oyster-tortoise shell decoction filtrate obtained in step (1), the concentrated solution obtained in step (3), the total decoction obtained in step (4), and the salvia miltiorrhiza-angelica decoction filtrate obtained in step (5), and concentrating them by rotary evaporation to a paste to obtain an extract with a relative density of 1.12, and then drying the extract (drying under reduced pressure at 70° C.), crushing, and sieving to obtain an extract powder;

[0063] (7) uniformly mixing the extract powder with microcrystalline cellulose and mannitol, and then adding ethanol to prepare a soft material; wherein: the total mass of the microcrystalline cellulose and mannitol is the same as the mass of the extract powder, the mass ratio of the microcrystalline cellulose to the mannitol is 2:1, the ethanol is an ethanol aqueous solution with a volume fraction of 85%, and the mass of the ethanol aqueous solution is 25% of the mass of the soft material;

[0064] (8) The soft material is extruded and passed through a 16-mesh sieve to obtain wet granules, and then the wet granules are placed in a drying oven at 60° C. and dried under reduced pressure. After completion, the wet granules are sized through a 14-mesh sieve to obtain Chinese medicine formula granules for treating sleep disorders in perimenopausal women.

[0065] Effect Example

[0066] 50 patients with perimenopausal sleep disorders were asked to take the Chinese medicine granules prepared in Example 1, three times a day, one bag (3 g) each time, for 14 days, and a follow-up visit was conducted after 30 days. The details are as follows:

[0067] Efficacy Description:

[0068] (I) Inclusion criteria: ① All participants were in menopause and had varying degrees of insomnia; ② All basic information was complete and there was no allergic reaction to the therapeutic drugs and methods used in this study; ③ No medication for insomnia was taken within 1 month before participating in this study.

[0069] (II) Refer to the international unified standard Pittsburgh Sleepiness Index (PSQI) assessment standard, expressed as PSQI reduction rate, see formula: PSQI reduction rate = (pre-medication score - post-medication score) / pre-medication score × 100%

[0070] (1) Recovery: PSQI total score reduction rate after treatment>75%

[0071] (2) Significant effect: 75% ≥ PSQI total score reduction rate after treatment > 50%

[0072] (3) Effective: 50% ≥ PSQI total score reduction rate after treatment > 25%

[0073] (4) Ineffective: The PSQI total score reduction rate after treatment is ≤25%, or increases compared with that before treatment.

[0074] Total effective rate = (cured + markedly effective + effective) / total number of cases × 100%

[0075] Results: A total of 50 people took the medicine, of whom 3 dropped out (i.e. a total of 47 cases), 40 recovered, 2 showed significant effects, 3 were effective, and 2 were ineffective. The total effective rate was 95.7%.

[0076] (III) Perimenopause symptoms:

[0077] (1) Cured: After treatment, the patient's symptoms such as hot flashes, sweating, abnormal mood, fever in the five parts of the body, depression, and pain in the waist and knees completely disappeared, and the Kupperman score decreased by ≥90%;

[0078] (2) Markedly effective: clinical symptoms were significantly improved after treatment, with the Kupperman score decreasing by 60% to 89%;

[0079] (3) Effective: clinical symptoms were partially improved after treatment, and the Kupperman score decreased by 30% to 59%;

[0080] (4) Ineffectiveness means no clinical improvement after treatment, and the Kupperman score decreases by less than 30%.

[0081] Total effective rate = (cured + markedly effective + effective) / total number of cases × 100%

[0082] Results: A total of 50 people took the medicine, of whom 3 dropped out (i.e. a total of 47 cases), 41 recovered, 4 showed significant effects, 1 was effective, and 1 was ineffective. The total effective rate was 97.8%.

[0083] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. A Chinese medicine granule for treating sleep disorders in perimenopausal women, characterized in that: The Chinese medicine formula granules include the following raw materials in parts by weight: 3-5 parts of mother-of-pearl, 8-10 parts of raw oysters, 3-5 parts of cypress seeds, 3-4 parts of roasted licorice, 3-5 parts of Ligustrum lucidum fruits, 3-5 parts of Eclipta prostrata, 3-5 parts of raw Ziziphus jujuba seeds, 8-10 parts of tortoise shells, 8-10 parts of salvia miltiorrhiza, and 3-5 parts of angelica sinensis.

2. The Chinese medicine formula granules for treating sleep disorders in perimenopausal women according to claim 1, characterized in that: The Chinese medicine formula granules include the following raw materials in parts by weight: 5 parts of mother of pearl, 10 parts of raw oyster, 5 parts of cypress seed, 3.3 parts of roasted licorice, 5 parts of Ligustrum lucidum fruit, 5 parts of Eclipta prostrata, 5 parts of raw spinulosa seed, 10 parts of tortoise shell, 10 parts of salvia miltiorrhiza, and 5 parts of angelica.

3. The method for preparing the Chinese medicine formula granules for treating sleep disorders in perimenopausal women according to claim 1 or 2, characterized in that: The preparation method comprises the following steps: (1) mixing mother-of-pearl, raw oysters, tortoise shells and water and boiling them, and filtering to obtain a mother-of-pearl-raw oyster-tortoise shell boiling filtrate; (2) adding pine nuts, roasted liquorice, Ligustrum lucidum fruit, Eclipta prostrata, and raw Ziziphus jujuba seeds into ethanol for ultrasonic extraction, and filtering to obtain a filter residue and an extract; (3) combining the extracts of the respective components in step (2) to obtain a total extract; and then concentrating the total extract until there is no alcohol taste to obtain a concentrated solution; (4) combining the filter residues of the respective components in step (2) to obtain a total filter residue; and then boiling the total filter residue with water to obtain a total decoction; (5) mixing salvia miltiorrhiza and angelica sinensis with water and decocting the mixture, and filtering the mixture to obtain a salvia miltiorrhiza-angelica sinensis decoction filtrate; (6) combining the pearl mother-oyster-tortoise shell decoction filtrate obtained in step (1), the concentrated solution obtained in step (3), the total decoction obtained in step (4), and the salvia miltiorrhiza-angelica decoction filtrate obtained in step (5), and concentrating the mixture by rotary evaporation to a paste to obtain an extract, and then drying, crushing, and sieving the extract to obtain an extract powder; (7) uniformly mixing the extract powder and the mixed auxiliary materials, and then adding ethanol to prepare a soft material; (8) The soft material is granulated and dried in sequence to obtain Chinese medicine formula granules for treating sleep disorders in perimenopausal women.

4. The preparation method according to claim 3, characterized in that: In step (1), the mother-of-pearl, raw oyster and tortoise shell are mixed with 18 to 22 times of water and boiled, and the mixture is kept in a boiling state for 2 to 3 hours and then filtered to obtain a filter residue and a primary filtrate; the filter residue is then boiled with water of the same mass and filtered to obtain a secondary filtrate; the primary filtrate and the secondary filtrate are combined; the mixture is boiled three times according to the above steps, and all the filtrates are combined to obtain a mother-of-pearl-raw oyster-tortoise shell decoction filtrate.

5. The preparation method according to claim 3, characterized in that: In step (2), arborvitae seeds, roasted liquorice, Ligustrum lucidum fruit, Eclipta prostrata and raw jujube seeds are added to ethanol aqueous solutions with volume concentrations of 90%, 60% and 30% in sequence, and ultrasonic-assisted extraction is performed for 30 to 35 minutes at an ultrasonic power of 100 to 120 W and a temperature of 50 to 55° C. After completion, filtering is performed to obtain a filter residue and an extract.

6. The preparation method according to claim 3, characterized in that: In step (4), the filter residues of the respective components in step (2) are combined to obtain a total filter residue; and the total filter residue is then boiled in water for 3 to 4 times to obtain a total decoction.

7. The preparation method according to claim 3, characterized in that: In step (5), Danshen and Angelica are mixed with 12 to 14 times the mass of water and decocted for 3 to 4 times, each decocting time being 1.5 to 2 hours. After completion, the decocting filtrate is filtered and combined to obtain Danshen-Angelica decoction filtrate.

8. The preparation method according to claim 3, characterized in that: In step (6), the extract is concentrated by rotary evaporation under reduced pressure at 70°C, and the relative density of the extract is 1.12; and / or the drying method is: drying under reduced pressure at 70°C.

9. The preparation method according to claim 3, characterized in that: In step (7), the mass ratio of the extract to the mixed excipient is 1:1; and / or the mixed excipient includes microcrystalline cellulose and mannitol, the mass ratio of the microcrystalline cellulose to the mannitol is 2:1, and / or the ethanol is an ethanol aqueous solution with a volume fraction of 85%, and the mass of the ethanol aqueous solution is 25% of the mass of the soft material.

10. The preparation method according to claim 3, characterized in that: In step (8), the soft material is extruded and passed through a 16-mesh sieve to obtain wet granules, and then the wet granules are placed in a drying oven at 60° C. and dried. After completion, the wet granules are sieved through a 14-mesh sieve to obtain Chinese medicine formula granules for treating sleep disorders in perimenopausal women.