Medicine for treating menopausal syndrome insomnia and preparation method thereof

Abstract

The invention discloses a medicine for treating menopausal syndrome insomnia. The medicine is prepared from radix pseudostellariae, radix ophiopogonis, schisandra chinensis, semen ziziphi spinosae, semen boitae, polygala tenuifolia, nacre mother of pearl, coptis chinensis, donkey-hide gelatin, radix rehmanniae, lily, vine of multiflower knotweed, jujube, radix paeoniae alba and liquorice. The traditional Chinese medicine composition has the effects of nourishing yin to lessen fire, regulating heart and kidney, calming heart and tranquilizing mind. The traditional Chinese medicine composition can be used for treating menopausal syndrome insomnia caused by heart-kidney disharmony due to the fact that kidney fluid cannot flow upwards and heart fire cannot be reduced, and is suitable for chemotherapy patients with menopausal syndrome insomnia.

Description

Field of the Invention

[0001] The invention relates to a medicine for treating menopausal syndrome insomnia and a preparation method thereof, belonging to the technical field of medicines. Background Art

[0002] Menopausal syndrome refers to a series of physical and mental symptoms caused by fluctuations or reductions in sex hormones before and after menopause, such as menstrual disorders, unstable vasomotor function, autonomic dysfunction, mental symptoms, abnormal urogenital function, osteoporosis, etc. Surveys show that the incidence of menopausal syndrome is as high as 90%, of which insomnia can reach 76.8%, including 10-30% severe insomnia, which is one of the most common and frequent symptoms of menopausal syndrome that patients find unbearable. The main manifestations of insomnia in menopausal syndrome are: abnormal sleep symptoms (poor sleep onset, poor sleep maintenance, early awakening, etc.) and daytime symptoms (fatigue, general discomfort, emotional disorders, behavioral problems, etc.). The ancients said: "Those who can sleep and eat can live long." Sleep is a necessary physiological process for the human body. Effective sleep can restore people's spirit and physical strength, and help improve the body's immunity and enhance resistance; ineffective sleep cannot effectively restore the body's functions, affecting physical and mental health, and at the same time bringing heavy mental pressure to patients.

[0003] Modern medicine believes that the pathogenesis of insomnia caused by menopausal syndrome is mainly related to the gradual decline of ovarian function and disorder of sex hormone secretion in women before and after menopause

[18] . Among them, insufficient estrogen secretion directly or indirectly affects the regulation of sleep-wake mechanism, and the influence of social and psychological factors leads to the occurrence of insomnia caused by menopausal syndrome. Western medicine mainly treats insomnia caused by menopausal syndrome by symptomatic treatment, mainly using sex hormones and sedatives, which can effectively improve women's sleep state; however, the side effects are large. For example, long-term use of sex hormones will increase the risk of abnormal uterine bleeding, reproductive organ cancer, cardiovascular and cerebrovascular diseases, etc.; long-term use of sedatives can easily lead to drug resistance, addiction, withdrawal syndrome, etc., resulting in poor patient compliance.

[0004] Traditional Chinese medicine has inherited the essence of traditional medicine for thousands of years. It has a variety of treatment methods for insomnia caused by menopausal syndrome. It focuses on overall conditioning, which can not only improve insomnia symptoms, but also improve hot flashes, night sweats, anxiety and depression. It has significant therapeutic effects, treats both the symptoms and the root causes, has few side effects, and has good compliance. Therefore, the use of traditional Chinese medicine to treat insomnia caused by menopausal syndrome is increasingly receiving attention and recognition.

[0005] The drug formulation of the present invention has the effects of nourishing yin and reducing fire, connecting the heart and kidney, and calming the mind. It can treat insomnia of menopausal syndrome caused by the failure of kidney water to ascend and heart fire to descend, resulting in the failure of heart and kidney to communicate. It is suitable for chemotherapy patients with insomnia of menopausal syndrome, and has few side effects and good patient compliance. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a medicine for treating insomnia of menopausal syndrome and a preparation method thereof. The present invention has the effects of nourishing yin and reducing fire, connecting the heart and kidney, and calming the mind and tranquilizing the spirit, and can treat insomnia of menopausal syndrome caused by the failure of kidney water to ascend and heart fire to descend, and is suitable for chemotherapy patients with insomnia of menopausal syndrome.

[0007] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0008] A medicine for treating insomnia caused by menopausal syndrome, wherein the effective medicinal ingredients are calculated by weight as follows: 50-300 parts of Pseudostellariae Radix, 40-200 parts of Radix Ophiopogonis, 40-200 parts of Fructus Schisandrae Chinensis, 150-500 parts of Semen Ziziphi Spinosae, 40-200 parts of Semen Platycladi, 30-200 parts of Polygala Tenuifolia, 150-500 parts of Mother of Pearl, 50-300 parts of Coptis Chinensis, 50-300 parts of Ejiao, 50-300 parts of Radix Rehmanniae, 50-300 parts of Lilium, 30-200 parts of Radix Polygoni Multiflori, 150-500 parts of Jujube, 50-300 parts of White Peony Root, and 20-120 parts of Licorice

[0009] The above-mentioned medicine for treating insomnia due to menopausal syndrome, its medicinal active ingredients are calculated by weight: 100-200 parts of Pseudostellariae Radix, 80-160 parts of Ophiopogon japonicus, 80-160 parts of Schisandrae Chinensis, 200-400 parts of Ziziphus jujuba seeds, 80-160 parts of Platycladus orientalis, 50-150 parts of Polygala tenuifolia, 200-400 parts of Mother of Pearl, 100-200 parts of Coptis chinensis, 100-200 parts of donkey-hide gelatin, 100-200 parts of Rehmannia root, 100-200 parts of Lilium, 50-150 parts of Polygonum multiflorum, 200-400 parts of jujube, 100-200 parts of White Peony Root, and 30-90 parts of Licorice.

[0010] Specifically, the aforementioned medicine for treating insomnia due to menopausal syndrome, its medicinal active ingredients are calculated by weight: 150 parts of Pseudostellariae Radix, 120 parts of Ophiopogon japonicus, 120 parts of Schisandrae Chinensis, 300 parts of Semen Ziziphi Spinosae, 120 parts of Platycladus orientalis, 100 parts of Polygala tenuifolia, 300 parts of Mother of Pearl, 150 parts of Coptis chinensis, 150 parts of donkey-hide gelatin, 150 parts of Rehmannia root, 150 parts of Lilium, 100 parts of Polygonum multiflorum, 300 parts of Jujube, 150 parts of White Peony Root, and 60 parts of Licorice.

[0011] For the aforementioned drugs for treating insomnia due to menopausal syndrome, if the patients with insomnia due to menopausal syndrome have obvious hot flashes and night sweats, add raw dragon bone, raw oyster, sweet wormwood, tortoise shell and turtle shell to the formula;

[0012] For the aforementioned drugs for treating insomnia due to menopausal syndrome, if the patients suffer from obvious dizziness and tinnitus, add Uncaria rhynchophylla, chrysanthemum, Gastrodia elata and Semen Cassiae to the formula.

[0013] For the aforementioned drugs for treating insomnia due to menopausal syndrome, if patients with insomnia due to menopausal syndrome experience obvious fatigue and weakness, add astragalus, codonopsis pilosula, atractylodes macrocephala, polygonatum sibiricum and jujube to the prescription.

[0014] For the aforementioned drugs for treating insomnia due to menopausal syndrome, if patients suffer from obvious weakness in waist and knees due to insomnia due to menopausal syndrome, add Chuanduan, Viscum album, Psoralea corylifolia, Morinda officinalis and Eucommia ulmoides to the prescription.

[0015] For the aforementioned drugs for treating insomnia due to menopausal syndrome, if patients with insomnia due to menopausal syndrome have obvious urinary pain and burning, add Lophatherum gracile, Rhizoma Alismatis, Phellodendron amurense and Taraxacum officinale to the formula.

[0016] The preparation method of the above-mentioned medicine for treating insomnia caused by menopausal syndrome comprises weighing all the medicinal materials in the prescription according to a proportion, and processing them according to a conventional preparation method to prepare a corresponding pharmaceutical preparation.

[0017] The aforementioned pharmaceutical preparations include decoctions, hard capsules, granules, tablets or oral liquid preparations.

[0018] The above-mentioned decoction paste is prepared as follows:

[0019] (1) Stir-frying sugar: Put sugar in a pot, stir-fry frequently until it is completely dissolved and turns yellow. When it starts to foam and emits a little bluish-white smoke, the sugar is ready for use.

[0020] (2) Weigh each medicinal material according to the prescription ratio, add 10 times the amount of water, soak for 0.5 hours, boil and reflux for extraction twice, each time for 1 hour, combine the two extracts, mix well, and concentrate to 70% of the original drug solution. Filter while hot, and concentrate the filtrate to an extract with a relative density of 1.25-1.35 at 50°C. Take 50-60% of the weight of the above extract in fried sugar, slowly add it to the above extract, stir well, continue to heat over low heat to collect the paste, and wait until a small amount can be pulled into a thread or dripped on paper without water marks, put it into a sterile bottle and seal it.

[0021] The hard capsule is prepared as follows: weigh each medicinal material according to the prescription ratio, add 8 times the amount of water, soak for 0.5 hours, boil and reflux for extraction 3 times, each time for 0.5 hours, combine the three extracts, mix well, concentrate to 70% of the original drug solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.25-1.35 at 50°C, dry the extract at 80°C to form a dry extract, grind it into fine powder, add 15% pregelatinized starch, 2% dextrin and 1% microcrystalline cellulose in the preparation amount, mix well, granulate with 85% ethanol, dry at 80°C, granulate, fill capsules, and obtain the hard capsule.

[0022] The above-mentioned granules are prepared as follows: weigh each medicinal material according to the prescription ratio, add 12 times the amount of water, soak for 0.5 hours, boil and reflux for extraction 3 times, each time for 1 hour, combine the three extracts, mix well, concentrate to 70% of the original drug solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.25-1.35 at 50°C, dry under reduced pressure, and crush into fine powder to obtain a dry extract. Take 1 part of the dry extract and 1 part of sucrose, prepare granules by wet method with 85% ethanol, dry at 75-85°C after the granules are made, pass through a 16-mesh sieve once, and separate the fine powder with a 100-mesh sieve to obtain the granules.

[0023] The above-mentioned tablets are prepared as follows: weigh each medicinal material according to the prescription ratio, add 6 times the amount of water, soak for 0.5 hours, boil and reflux and extract twice, each time for 1.5 hours, combine the two extracts, mix well, concentrate to 70% of the original drug solution, filter while hot, concentrate and dry the filtrate to 3-3.5% of moisture, and grind it into fine powder, use 10% starch alcohol slurry to make a soft material, granulate through a 16-mesh sieve, dry at 55°C, add 2% sodium carboxymethyl starch, 1% micro-powder silica gel and 1% magnesium stearate to mix well, press into tablets, and film-coat to obtain the tablets.

[0024] The above-mentioned oral liquid preparation is prepared as follows: weigh each medicinal material according to the prescription ratio, add 8 times the amount of water, soak for 0.5 hours, boil and reflux for extraction twice, each time for 2 hours, combine the two extracts, mix well, and concentrate to 70% of the original drug solution. After cooling, add 2 times the amount of 85% ethanol and let it stand overnight. After the ethanol is recovered, add 10% stevioside, 3% citric acid and 0.2% sodium benzoate, stir well, filter, and concentrate to a relative density of 1.10-1.05 at room temperature.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] The drug for treating insomnia caused by menopausal syndrome is prepared from Radix Pseudostellariae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Semen Ziziphi Spinosae, Semen Platycladi, Radix Polygalae, Mother of Pearl, Rhizoma Coptidis, Ejiao, Radix Rehmanniae, Lilium, Radix Polygoni Multiflori, Jujube, White Peony Root and Radix Glycyrrhizae. The properties and effects of each component are as follows: Radix Pseudostellariae is a plant of Caryophyllaceae family, Glehnia littoralis

[0027] The dried root of Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm. is sweet and slightly bitter, and has a neutral nature. It enters the spleen and lung meridians. It has the effects of invigorating qi and strengthening the spleen, promoting fluid and moistening the lungs. It is used for spleen deficiency, fatigue, loss of appetite, weakness after illness, insufficient qi and yin, spontaneous sweating and thirst, and dry cough due to lung dryness. Ophiopogon japonicus (Lf) Ker-Gawl. is a dried root of the Liliaceae plant Ophiopogon japonicus (Lf) Ker-Gawl. It is sweet and slightly bitter, and has a slightly cold nature. It enters the heart, lung, and stomach meridians. It has the effects of nourishing yin and promoting fluid, moistening the lungs and clearing the heart. It is used for dry cough due to lung dryness, tuberculosis due to yin deficiency, sore throat and pharynx, thirst due to fluid loss, internal heat and thirst, restlessness and insomnia, and constipation due to dry intestines. Schisandra chinensis is the dried mature fruit of Schisandra chinensis (Turcz.) Baill. of the Magnoliaceae family; it tastes sour and sweet, and is warm in nature; it enters the lung, heart, and kidney meridians; it has the effects of astringing, strengthening qi, promoting the production of body fluid, and tonifying the kidney and calming the mind; it is used for chronic cough, asthenia, nocturnal emission, spermatorrhea, enuresis, frequent urination, chronic diarrhea, spontaneous sweating, night sweats, thirst due to loss of body fluid, internal heat and thirst, palpitations and insomnia. Ziziphus jujuba is the dried mature seed of Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex HFChou of the Rhamnaceae family; it tastes sweet and sour, and is neutral in nature; it enters the liver, gallbladder, and heart meridians; it has the effects of nourishing the heart and liver, calming the mind and tranquilizing the nerves, astringing sweat, and promoting the production of body fluid; it is often used for insomnia due to deficiency, palpitations and dreams, excessive sweating due to physical weakness, and thirst due to loss of body fluid. Platycladus orientalis (L.) Franco, a plant of the Cupressaceae family, is a dried mature seed kernel. The mature seeds are harvested in autumn and winter, dried in the sun, the seed coat is removed, and the kernels are collected. It is sweet and neutral in nature. It enters the heart, kidney, and large intestine meridians. It has the effects of nourishing the heart and calming the mind, moistening the intestines and relieving constipation, and stopping sweating. It is used for yin-blood deficiency, insomnia due to deficiency, palpitations, constipation due to dry intestines, and night sweats due to yin deficiency. Polygala is the dried root of Polygala tenuifolia Willd. or Polygalasibirica L., a plant of the Polygalaceae family. It is bitter and pungent in taste and warm in nature. It enters the heart, kidney, and lung meridians. It has the effects of calming the mind and improving intelligence, connecting the heart and kidney, removing phlegm, and reducing swelling. It is used for insomnia, dreaminess, forgetfulness, palpitations, confusion, coughing and expectoration, sores, swelling, and breast pain caused by disharmony between the heart and kidney. Mother of pearl is the shell of the Hyriopsis cumingii (Lea) of the family Hyriopsis, the Cristaria p1icata (leach) of the family Leach, or the Pteria martensii (Dunker) of the family Pearl Oysteridae. It tastes salty and is cold in nature. It enters the liver and heart meridians. It has the effects of calming the liver and suppressing yang, calming the mind and relieving shock, improving eyesight and removing cataracts. It is used to treat headaches, dizziness, palpitations, insomnia, red eyes, cataracts, and blurred vision.Coptis chinensis is the dried rhizome of Coptis chinensis Franch., Coptis deltoidea C.Y.Cheng et Hsiao or Coptis teeta Wall. of the Ranunculaceae family. It tastes bitter and is cold in nature. It enters the heart, spleen, stomach, liver, gallbladder and large intestine meridians. It has the effects of clearing away heat and dampness, purging fire and detoxifying. It is used for damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and coma, hyperactivity of heart fire, restlessness and insomnia, palpitations, vomiting and bleeding due to blood heat, red eyes, toothache, diabetes, carbuncle and furuncle; it is also used externally to treat eczema, wet sores and pus in the ear canal. Ejiao is a solid glue made by boiling and concentrating the dried or fresh skin of Equus asinus L., an equine animal. It is sweet in taste and neutral in nature. It enters the lung, liver and kidney meridians. It has the effects of nourishing blood and yin, moistening dryness and stopping bleeding. It is used for blood deficiency and sallow complexion, dizziness and palpitations, muscle weakness, restlessness and insomnia, internal wind movement, dry lung cough, hemoptysis due to overwork, hematuria and hematuria, hematochezia and metrorrhagia, and pregnancy and fetal leakage. Shengdihuang is the fresh or dried root of Rehmannia glutinosa Libosch., a plant of the Scrophulariaceae family, which is slowly baked to about 80% dry. It is sweet in taste and cold in nature. It enters the heart, liver and kidney meridians. It has the effects of clearing heat and cooling blood, nourishing yin and promoting body fluid, and is used for heat entering the blood, fever caused by warm poison, hematemesis and epistaxis, yin damage caused by febrile disease, red tongue and thirst, body fluid damage and constipation, yin deficiency fever, bone steaming and overwork fever, and internal heat and thirst. Lily is the dried fleshy scales of Lilium lancifolium Thunb., Lilium brownii FEBrownvar.viridulum Baker or Lilium pumilum DC, which are plants of the Liliaceae family. It is dug in autumn, washed, peeled, and scalded in boiling water, and dried. It is sweet and cold in nature. It enters the heart and lung meridians. It has the effects of nourishing yin and moistening the lungs, clearing the heart and calming the mind. It is used for dry cough due to yin deficiency, cough with blood due to overwork, restlessness, palpitations, and mental confusion. Polygonum multiflorum is the dried vine stem of Polygonum multiflorum Thunb., which is sweet and neutral in nature. It enters the heart and liver meridians. It has the effects of nourishing blood and calming the mind, dispelling wind and unblocking the meridians. It is used for insomnia, dreaminess, body pain due to blood deficiency, rheumatic pain, and skin itching. The jujube is also known as jujube, jujube, thorny jujube, and jujube; it is the mature fruit of the jujube (Ziziphus jujuba Mill.) of the Rhamnaceae family; it tastes sweet and is warm in nature; it enters the spleen meridian and stomach meridian; it has the effects of tonifying the middle and replenishing qi, nourishing blood and calming the mind, and nourishing the spleen and stomach; the role of red dates is to treat spleen and stomach disharmony, indigestion, cough caused by fatigue, anemia and weight loss, and the taboo of eating red dates is constipation, and those with severe internal heat should not eat red dates. White peony is the dried root of the Ranunculaceae plant Paeonia lactiflora Pall.; it tastes bitter and sour, and is slightly cold in nature; it enters the liver and spleen meridians; it has the effects of nourishing blood and regulating menstruation, restraining yin and stopping sweating, softening the liver and relieving pain, and calming liver yang; it is used for blood deficiency and sallow complexion, irregular menstruation, spontaneous sweating, night sweats, flank pain, abdominal pain, limb cramps, headache and dizziness.Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch. Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the Leguminosae family. It is dug in spring and autumn, the fibrous roots are removed, and it is dried in the sun. It tastes sweet and is neutral in nature. It enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving pain, and harmonizing various medicines. It is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, acute pain in the abdomen and limbs, carbuncles, sores, and relieves the toxicity and potency of drugs.

[0028] Solution

[0029] In the formula, Radix Pseudostellariae is sweet, bitter and slightly warm, which can nourish qi and yin, produce fluid and moisten dryness; Radix Ophiopogonis replenishes the source of water to nourish yin and moisten dryness, and clears the heat of the heart meridian and relieves restlessness; Ejiao enters the kidney meridian to nourish water, nourish the kidney and replenish qi, harmonize blood and replenish yin; the three herbs are used together to nourish qi and nourish yin, and nourishing yin and kidney is the main herb; Coptis chinensis is bitter and enters the heart, and is cool and heat-relieving to relieve restlessness; Radix Rehmanniae cools blood and clears heat, nourishes yin and nourishes kidney, produces fluid and quenches thirst; the two herbs are used together to nourish yin and clear heat; Schisandrae Chinensis replenishes qi and produces fluid, nourishes the kidney and nourishes the heart, and can also nourish yin and restrain sweat; White peony root softens the liver, nourishes yin and blood, and nourishes kidney yin; jujube seeds are sour and enter the heart and liver, benefiting liver blood and calming the mind; mother-of-pearl clears the heart and calms the nerves; the above medicines are used together to nourish yin and reduce fire, calm the mind and calm the nerves as the minister; with Polygala tenuifolia to calm the mind and calm the heart, strengthen the will and connect the heart and kidney; Polygonum multiflorum nourishes blood and calms the mind; Platycladus seed nourishes yin and calms the mind; lily and mother-of-pearl clear the heart and calm the nerves; together as adjuvants to calm the mind and calm the nerves, and connect the heart and kidney; licorice is used to harmonize the various medicines, and can be used with sour jujube seeds to acidify yin and harmonize yin and yang. The whole prescription has the effects of nourishing yin and reducing fire, connecting the heart and kidney, and calming the mind. It can treat menopausal syndrome insomnia caused by the inability of kidney water to ascend and the inability of heart fire to descend, which is caused by the disharmony between the heart and kidney, and is suitable for chemotherapy patients with menopausal syndrome insomnia. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 :Prescription sheet of embodiment 1;

[0031] Figure 2 : Example 1 outpatient records;

[0032] Figure 3 : Example 1 Clinical Observation Table;

[0033] Figure 4 : Embodiment 2 prescription note;

[0034] Figure 5 : Example 2 Clinical Observation Table;

[0035] Figure 6 : Embodiment 3 prescription note;

[0036] Figure 7 : Example 3 outpatient records. DETAILED DESCRIPTION

[0037] The present invention will be further described below in conjunction with the embodiments, but they are not intended to limit the present invention.

[0038] Example 1.

[0039] Prescription: 150g of Pseudostellaria heterophylla, 120g of Ophiopogon japonicus, 120g of Schisandra chinensis, 300g of Ziziphus jujuba seed, 120g of Torreya grandis seed, 100g of Polygala tenuifolia, 300g of mother-of-pearl, 150g of Coptis chinensis, 150g of donkey-hide gelatin, 150g of Rehmannia root, 150g of Lilium, 100g of Polygonum multiflorum, 300g of jujube, 150g of White Peony Root, and 60g of Licorice.

[0040] Preparation process:

[0041] (1) Stir-frying sugar: Place sugar in a suitable pot, stir-fry frequently until it is completely dissolved and turns yellow. When it starts to foam and produces a little bluish-white smoke, the sugar is ready for use.

[0042] (2) Weigh each medicinal material according to the prescription ratio, add 10 times the amount of water, soak for 0.5 hours, boil and reflux for extraction twice, each time for 1 hour, combine the two extracts, mix well, and concentrate to 70% of the original drug solution. Filter while hot, and concentrate the filtrate to an extract with a relative density of 1.25-1.35 at 50°C. Take 50-60% of the weight of the above extract in fried sugar, slowly add it to the above extract, stir well, continue to heat over low heat to collect the paste, and wait until a small amount can be pulled into a thread or dripped on paper without water marks, put it into a sterile bottle and seal it to obtain a decoction.

[0043] Dosage and Administration: Take three times a day, morning, noon and evening, 20-30g each time.

[0044] Example 2.

[0045] Prescription: 50g of Pseudostellaria chinensis, 40g of Ophiopogon japonicus, 40g of Schisandra chinensis, 500g of Ziziphus jujuba seed, 200g of Torreya grandis seed, 30g of Polygala tenuifolia, 500g of mother-of-pearl, 300g of Coptis chinensis, 300g of donkey-hide gelatin, 50g of Rehmannia glutinosa, 50g of Lilium bulb, 200g of Polygonum multiflorum, 500g of Jujube, 300g of White Peony Root, and 120g of Licorice.

[0046] Preparation process:

[0047] Weigh each medicinal material according to the prescription ratio, add 8 times the amount of water, soak for 0.5 hour, boil and reflux for extraction 3 times, each time for 0.5 hour, combine the three extracts, mix well, concentrate to 70% of the original drug solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.25-1.35 at 50°C, dry the extract at 80°C to form a dry extract, grind into fine powder, add 15% pregelatinized starch, 2% dextrin and 1% microcrystalline cellulose, mix well, granulate with 85% ethanol, dry at 80°C, granulate whole, fill into capsules, and obtain hard capsules.

[0048] Dosage and Administration: Take three times a day, morning, noon and evening, 3-5g each time (1g / pill).

[0049] Example 3.

[0050] Prescription: 300g of Pseudostellaria heterophylla, 200g of Ophiopogon japonicus, 200g of Schisandra chinensis, 150g of Ziziphus jujuba seed, 40g of Torreya grandis seed, 200g of Polygala tenuifolia, 150g of mother-of-pearl, 50g of Coptis chinensis, 50g of donkey-hide gelatin, 300g of Rehmannia root, 300g of Lilium, 30g of Polygonum multiflorum, 150g of Jujube, 50g of White Peony Root, and 20g of Licorice.

[0051] Preparation process:

[0052] Weigh each medicinal material according to the prescription ratio, add 12 times the amount of water, soak for 0.5 hour, boil and reflux for extraction 3 times, each time for 1 hour, combine the three extracts, mix well, concentrate to 70% of the original drug solution, filter while hot, concentrate the filtrate to an extract with a relative density of 1.25-1.35 at 50°C, dry under reduced pressure, and grind into fine powder to obtain a dry extract. Take 1 part of the dry extract and 1 part of sucrose, prepare granules by wet method with 85% ethanol, dry at 75-85°C after the granules are made, pass through a 16-mesh sieve once, and use a 100-mesh sieve to separate the fine powder to obtain granules.

[0053] Dosage and Administration: Take three times a day, morning, noon and evening, 10-20g each time.

[0054] Example 4.

[0055] Prescription: 150g Pseudostellariae Radix, 180g Ophiopogon japonicus, 100g Schisandrae Chinensis, 300g Ziziphus jujuba seed, 100g Torreya grandis seed, 80g Polygala tenuifolia, 280g Mother of Pearl, 100g Coptis chinensis, 220g donkey-hide gelatin, 250g Rehmannia root, 180g Lilium, 180g Polygonum multiflorum, 170g Jujube, 90g White Peony Root, and 50g Licorice.

[0056] Preparation process:

[0057] Weigh each medicinal material according to the prescription ratio, add 6 times the amount of water, soak for 0.5 hour, boil and reflux for extraction twice, each time for 1.5 hours, combine the two extracts, mix well, concentrate to 70% of the original drug solution, filter while hot, concentrate and dry the filtrate to 3-3.5% moisture, and grind into fine powder, use 10% starch alcohol slurry to make a soft material, pass through a 16-mesh sieve to granulate, dry at 55°C, add 2% sodium carboxymethyl starch, 1% micro-powder silica gel and 1% magnesium stearate, mix well, press into tablets, and film-coat to obtain tablets.

[0058] Dosage and Administration: Take three times a day, morning, noon and evening, 4-6 tablets each time (1g / tablet).

[0059] Example 5.

[0060] Prescription: 280g of Pseudostellaria heterophylla, 170g of Ophiopogon japonicus, 90g of Schisandra chinensis, 350g of Ziziphus jujuba seed, 120g of Torreya grandis seed, 150g of Polygala tenuifolia, 320g of mother-of-pearl, 100g of Coptis chinensis, 200g of donkey-hide gelatin, 100g of Rehmannia root, 200g of Lilium, 70g of Polygonum multiflorum, 260g of Jujube, 270g of White Peony Root, and 90g of Licorice.

[0061] Preparation process:

[0062] Weigh each medicinal material according to the prescription ratio, add 8 times the amount of water, soak for 0.5 hour, boil and reflux for extraction twice, each time for 2 hours, combine the two extracts, mix well, and concentrate to 70% of the original drug solution. After cooling, add 2 times the amount of 85% ethanol and let stand overnight. After the ethanol is recovered, add 10% stevioside, 3% citric acid and 0.2% sodium benzoate, stir well, filter, and concentrate to a relative density of 1.10-1.05 at room temperature to obtain an oral liquid preparation.

[0063] Dosage and Administration: Take three times a day, morning, noon and evening, 10-20mL each time.

[0064] Example 6.

[0065] Prescription: Pseudostellariae Radix 15g, Ophiopogon japonicus 12g, Schisandrae Chinensis 12g, Ziziphus jujuba seed 30g, Torreya grandis seed 12g, Polygala tenuifolia 10g, Mother of Pearl 30g, Coptis chinensis 15g, Donkey-hide gelatin 15g, Rehmannia root 15g, Lilium 15g, Polygonum multiflorum 10g, Jujube 200g, White Peony 15g, Licorice 6g.

[0066] Preparation process:

[0067] Weigh each medicinal material according to the prescription ratio, add 8 times the amount of water, soak for 0.5 hour, boil and reflux for extraction 3 times, each time for 1 hour, and combine the three extracts to obtain a decoction.

[0068] Dosage and Administration: This dosage is for one day, take three times a day, morning, noon and evening.

[0069] Example 7.

[0070] Prescription: 90g of Pseudostellaria heterophylla, 120g of Ophiopogon japonicus, 180g of Schisandra chinensis, 410g of Ziziphus jujuba seed, 80g of Torreya grandis seed, 60g of Polygala tenuifolia, 250g of mother-of-pearl, 300g of Coptis chinensis, 100g of donkey-hide gelatin, 280g of Rehmannia root, 100g of Lilium, 30g of Polygonum multiflorum, 180g of Jujube, 100g of White Peony Root, and 120g of Licorice.

[0071] Preparation process:

[0072] (1) Stir-frying sugar: Put sugar in a pot, stir-fry frequently until it is completely dissolved and turns yellow. When it starts to foam and emits a little bluish-white smoke, the sugar is ready for use.

[0073] (2) Weigh each medicinal material according to the prescription ratio, add 10 times the amount of water, soak for 0.5 hours, boil and reflux for extraction twice, each time for 1 hour, combine the two extracts, mix well, and concentrate to 70% of the original drug solution. Filter while hot, and concentrate the filtrate to an extract with a relative density of 1.25-1.35 at 50°C. Take 50-60% of the weight of the above extract in fried sugar, slowly add it to the above extract, stir well, continue to heat over low heat to collect the paste, and wait until a small amount can be pulled into a thread or dripped on paper without water marks, put it into a sterile bottle and seal it to obtain a decoction.

[0074] Dosage and Administration: Take three times a day, morning, noon and evening, 20-30g each time.

[0075] The present invention has carried out a lot of experimental studies, and the following are the results of the experimental studies of the present invention:

[0076] 1. Clinical Trials

[0077] 1. Clinical research data and methods

[0078] 1.1 Case source

[0079] This study collected 60 outpatients who visited the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine between January 2019 and December 2024, were diagnosed with insomnia due to menopausal syndrome caused by cardiorenal disharmony, and met the inclusion criteria.

[0080] 1.2. Diagnostic criteria

[0081] 1.2.1. Western medicine diagnostic criteria

[0082] Refer to the "Chinese Classification and Diagnostic Criteria for Mental Disorders" CCMD-3 and the relevant diagnostic standards of the ninth edition of "Obstetrics and Gynecology".

[0083] (1) Age: 45-55 years old;

[0084] (2) Diagnosis of insomnia due to menopausal syndrome:

[0085] 1) Difficulty falling asleep: duration of falling asleep > 30 minutes;

[0086] 2) Sleep maintenance disorder: easy awakening (>2 times), early awakening, and difficulty falling asleep after awakening;

[0087] 3) Decreased sleep quality: shallow sleep and frequent dreams;

[0088] 4) Short total sleep time: less than 5 hours of sleep per night;

[0089] 5) Daytime functional impairment: fatigue, depression or irritability, physical discomfort, cognitive impairment, etc.;

[0090] (3) The above symptoms occur at least three times a week and last for more than one month;

[0091] 1.2.2. TCM diagnostic criteria

[0092] With reference to the relevant diagnostic criteria of TCM Gynecology and the Guiding Principles for Clinical Research of New Chinese Medicines, the key points are as follows:

[0093] (1) Main symptoms: poor sleep, manifested as difficulty falling asleep or restless sleep or waking up easily after falling asleep, difficulty falling asleep again after waking up, waking up early or having trouble sleeping all night.

[0094] (2) Secondary symptoms: restlessness, dizziness, tinnitus, weakness in waist and knees, fever in the five parts of the body, dry throat and thirst, hot flashes, night sweats or menstrual disorders, etc.

[0095] (3) Tongue and pulse: The tongue is red or has a red tip, the tongue coating is thin yellow or less, and the pulse is fine and rapid.

[0096] Note: The main symptoms are required, and the secondary symptoms must have more than 2 items, combined with the tongue and pulse to make a diagnosis

[0097] 1.3 Case screening criteria

[0098] 1.3.1 Inclusion criteria:

[0099] (1) Female patients aged 45-55 years;

[0100] (2) Meet the Western medical diagnostic criteria for this disease;

[0101] (3) Those who meet the TCM syndrome differentiation criteria for this disease;

[0102] (4) Pittsburgh Sleep Quality Index (PSQI) > 7 points;

[0103] (5) Voluntarily participate in this study and sign the informed consent.

[0104] (Note: Menstruation is not included in this study)

[0105] 1.3.2 Exclusion criteria

[0106] (1) Those who do not meet the inclusion criteria;

[0107] (2) People with allergies, abusers and addicts of psychoactive substances or drugs;

[0108] (3) used antipsychotics, antidepressants, hypnotics, etc. in the week before the study;

[0109] (4) Patients with severe primary diseases of the cardiovascular and cerebrovascular systems, hematopoietic systems, and mental illness;

[0110] (5) Various secondary insomnia (severe infection of heart, brain, kidney, lung, etc.);

[0111] (6) Those who refuse to cooperate with medication and refuse to sign the informed consent form.

[0112] 1.3.3 Elimination criteria

[0113] (1) Subjects who fail to take medication as required or stop taking medication on their own;

[0114] (2) Those who need to terminate the experiment due to allergic reactions or adverse events during the experiment;

[0115] (3) Those who withdraw voluntarily.

[0116] 1.3.4 Quantitative Standards for TCM Symptoms:

[0117] The TCM symptom scores of patients were evaluated and recorded before treatment and after each course of treatment, and the efficacy was evaluated by observing the changes in the scores. The TCM symptom quantitative scoring standard was formulated with reference to the "Guidelines for Clinical Research of New Chinese Medicines", and the table is as follows:

[0118] Table 1 Quantitative scoring standards for TCM symptoms

[0119]

[0120]

[0121] Note: Tongue and pulse are recorded but not scored.

[0122] 1.4 Research Methods

[0123] 1.4.1 Grouping method

[0124] According to the random number table method, the 60 patients were divided into a treatment group and a control group, with 30 cases in each group.

[0125] 1.4.2 Treatment methods

[0126] (1) Treatment group: Patients took the prescription of “Shenmai Huanglian Ejiao Decoction” from Ding’s Gynecology Department. The prescription consists of Radix Pseudostellariae Radix, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Rehmanniae, Rhizoma Coptis Chinensis, Ejiao, White Peony Root, Semen Ziziphi Spinosae, Semen Platycladi, Radix Polygalae, Mother of Pearl, Radix Glycyrrhizae, Lilium Bulbosae, and Rhizoma Polygoni Multiflori. Patients started taking the medicine at the time of consultation, 1 dose per day, 3 times per day, 200 ml per time; 10 days as one course of treatment, 3 courses in total.

[0127] Clinical application:

[0128] ① If hot flashes and night sweats are obvious, add raw dragon bone, raw oyster, Artemisia annua, tortoise shell, and turtle shell; ② If dizziness and tinnitus are obvious, add Uncaria rhynchophylla, chrysanthemum, Gastrodia elata, and Semen Cassiae; ③ If fatigue and weakness are obvious, add Astragalus, Codonopsis pilosula, Atractylodes macrocephala, Polygonatum sibiricum, and jujube; ④ If soreness and weakness of waist and knees are obvious, add Chuanduan, Viscum album, Psoralea corylifolia, Morinda officinalis, and Eucommia ulmoides; ⑤ If urination is painful and burning, add Lophatherum gracile, Alisma orientale, Phellodendron chinense, and Taraxacum mongolicum; ⑥ If irritability, irritability, depression, add Albizzia julibrissin, Curcuma aromatica, and Toosendan fruit.

[0129] (2) Control group: Take Kuntai Capsules (produced by Guiyang Xintian Pharmaceutical Co., Ltd., approval number: National Medicine Standard Z20000083, dosage form: capsules. 0.5g per capsule, 12 capsules x 2). Start taking it when you see the doctor, 4 capsules at a time, 3 times a day, take with warm water half an hour after meals; 10 days is one course of treatment, and there are 3 courses in total.

[0130] (3) Precautions: Both groups of patients were advised to go to bed on time after taking the medicine. During the treatment period, they were not allowed to drink tea or coffee, take other sleeping pills or anti-anxiety and depression drugs, and eat less spicy food.

[0131] 1.5 Observation Method

[0132] (1) Observe and record the changes in the Pittsburgh Sleep Quality Index (PSQI) scores before and after each course of treatment. (Note: This study excluded those who had used hypnotic drugs in the past week, so the use of "hypnotic drugs" was not counted)

[0133] (2) Observe and record the changes in the scores of various TCM clinical symptoms and the total score before treatment and after each course of treatment.

[0134] (3) Observe and record the changes in the scores of the modified Kupperman scale before treatment and after each course of treatment.

[0135] 1.6 Observe adverse drug reactions during medication

[0136] Observe whether there are any adverse reactions during medication, such as nausea and vomiting, abdominal pain and diarrhea, skin itching, rashes, blisters, etc. If any of the above symptoms occur, make corresponding records, ask the patient to stop the medication in time, guide the patient to seek medical treatment if necessary, and exclude them from this study.

[0137] 1.7 Clinical efficacy evaluation indicators

[0138] 1.7.1 Determination of the efficacy of insomnia treatment:

[0139] The criteria are formulated based on the "Clinical Guidance for New Chinese Medicines", "Clinical Research Guidance for New Chinese Medicines for the Treatment of Female Menopausal Syndrome" (1997) and PSQI score reduction rate or score reduction. Cured: Insomnia symptoms disappear (sleep time is restored or the night sleep time is more than 6 hours, sleep is deep, and the spirit is full after waking up), PSQI total reduction rate ≥ 75% or score reduction ≥ 5 points.

[0140] Markedly effective: Insomnia symptoms were significantly improved (sleep time increased by more than 3 hours, sleep depth increased), PSQI score reduction rate ≥ 50% or reduction ≥ 3 points.

[0141] Effective: Insomnia symptoms are relieved (sleep time increases by less than 3 hours compared with before), PSQI score decreases by ≥25% or decreases by ≥1 point.

[0142] Ineffective: Insomnia symptoms were not significantly relieved or even aggravated after treatment, and the PSQI score reduction rate was less than 20%.

[0143] Note: PSQI score reduction rate = (pre-treatment score - total score after three courses of treatment) / pre-treatment score * 100% Total effective rate = (cured + markedly effective + effective) ÷ total number of cases

[0144] 1.7.2 Evaluation of TCM Symptoms and Efficacy of Insomnia in Menopausal Syndrome with Heart-Kidney Disharmony

[0145] Formulated based on the Diagnosis and Efficacy Standards for Traditional Chinese Medicine Diseases and the Guidelines for Clinical Research of New Chinese Medicines (2002 edition).

[0146] Efficacy index: n = (score before treatment - score after 3 courses of treatment) / score before treatment x 100%

[0147] Cured: After treatment, the main TCM symptoms and secondary TCM symptoms disappeared, n≥95%;

[0148] Markedly effective: After treatment, the main TCM symptoms and secondary TCM symptoms were significantly alleviated, 70%≤n<95%;

[0149] Effective: After treatment, the main TCM symptoms and secondary TCM symptoms did not improve or worsen, 30%≤n<70%;

[0150] Ineffective: After treatment, the main TCM symptoms and secondary TCM symptoms were not significantly alleviated or aggravated, n<30%.

[0151] 1.7.3 Domestic modified version of Kupperman scale for efficacy evaluation

[0152] Evaluation of the integral reduction rate calculated according to the nimodipine algorithm:

[0153] Efficacy index: n = (total score before treatment - total score after 3 courses of treatment) / total score before treatment × 100%

[0154] Cured: clinical symptoms basically disappeared after treatment, n>95%;

[0155] Markedly effective: Clinical symptoms were significantly alleviated after treatment, 70% <n<95%;

[0156] Effective: Clinical symptoms were alleviated after treatment, 30% <n<70%;

[0157] Ineffective: clinical symptoms did not change or changed insignificantly after treatment, n<30%.

[0158] 1.8 Statistical analysis

[0159] The statistical software SPSS26.0 was used to perform statistical processing on the clinical research results. If the normal distribution and variance homogeneity were met, the paired sample T test was used for intra-group comparison, and the independent sample T test was used for inter-group comparison; non-parametric tests were used for those that did not meet the normal distribution. When P < 0.05, the difference was statistically significant; when P > 0.05, the difference was not statistically significant.

[0160] 2. Research Results

[0161] 2.1 Comparison of basic conditions between groups before treatment

[0162] Before treatment, the age and disease course of the two groups of patients were both >0.05, and there was no statistically significant difference between the two groups, which was comparable. (See Table 2 for details)

[0163] Table 2: Comparison of basic conditions between the two groups before treatment (x±s)

[0164]

[0165] Note: According to t test, ● P>0.05, ▲ P>0.05,

[0166] 2.2 Comparison of efficacy after treatment

[0167] 2.2.1 Comparison of the efficacy of insomnia after treatment

[0168] There was no significant difference in the total PSQI score between the two groups before treatment (P>0.05), and the two groups were comparable. After the first, second, and third courses of treatment, the total effective rates of insomnia in the treatment group were 33.33%, 76.66%, and 93.32%, respectively; the total effective rates of the control group were 20.0%, 36.66%, and 73.32%, respectively. In the intra-group comparison, the total insomnia score between the two groups before treatment and after each course of treatment was significantly different (p<0.05); in the inter-group comparison, the total insomnia score between the two groups in each course of treatment was significantly different (P<0.05); in summary, the results of the study indicate that both groups can improve menopausal heart-kidney disharmony type insomnia, and the treatment group has outstanding efficacy, which is better than the control group. (See Tables 3 and 4 for details)

[0169] Table 3: Comparison of the efficacy of insomnia between the two groups (X±S)

[0170]

[0171] Table 4: Comparison of insomnia scores between the two groups (X±S)

[0172]

[0173] Note: P: comparison before and after treatment within the group; P ◆ : Comparison between groups before treatment; P■ : Comparison between groups after the first course of treatment; P ▲ : Comparison between groups after the second course of treatment; P ★ : Comparison among groups after the third course of treatment.

[0174] 2.2.2 Comparison of the efficacy of various factors of PSQI

[0175] Before treatment, there was no significant difference in the scores of each factor of PSQI between the two groups (P>0.05), which showed comparability. After treatment, the scores of each factor before treatment and after three courses of treatment were compared within the two groups, and the differences were statistically significant (p<0.05); compared between the two groups, there were significant differences in the time to fall asleep, sleep duration, daytime function, sleep quality, sleep efficiency, and sleep disorders after three courses of treatment (p<0.05). (See Table 5 for details)

[0176] Table 5 Comparative analysis of the scores of the six items of PSQI between the two groups (x±s)

[0177]

[0178] Note: P: comparison within the group before and after treatment; P: comparison between groups before treatment, P 2★ <0.05; P 2▲ >0.05.

[0179] 2.2.3 Comparison of TCM symptom efficacy

[0180] Before treatment: There was no significant difference in the total score and single score of TCM syndrome between the two groups (all P>0.05), and they were comparable. After the first, second and third courses of treatment, the total effective rates of the treatment group were 63.%, 76.67% and 93.33%, respectively; the total effective rates of the control group were 50%, 63.32% and 76.67%, respectively. Intra-group comparison: There was a significant difference in the total score between the two groups before treatment and after the three courses of treatment (p<0.05); between-group comparison: There was no significant difference in the total score between the two groups in the first course of treatment (p>0.05), and there was a significant difference in the total score between the second and third courses of treatment (all p<0.05). There was a significant difference in the single symptom score between the two groups before treatment and after the third course of treatment (all p<0.05). (See Tables 6, 7 and 8 for details)

[0181] Table 6: Comparison of the total efficacy of TCM symptoms between the two groups (X±S)

[0182]

[0183] Table 7: Comparison of total TCM symptom scores between the two groups (points, x±s)

[0184]

[0185] Note: P value indicates intra-group comparison, P △ : Comparison between groups before treatment; P ▲ : Comparison between groups after the first course of treatment; P ○ : Comparison between groups after the second course of treatment; P ● : Comparison among groups after the third course of treatment.

[0186] Table 8: Comparison of TCM single symptom scores between the two groups (scores x±s)

[0187]

[0188] Note: P: comparison within the group before and after treatment; P2: comparison between groups before treatment, P 2★ <0.05; P 2▲ >0.05.

[0189] 2.2.4. Comparison of efficacy of the domestic modified Kupperman scale

[0190] Before treatment: There was no significant difference in the total score and single score of the modified Kupperman scale between the two groups (all P>0.05), which was comparable. After the first, second and third courses of treatment, the effective rates of the treatment group were 60%, 76.67% and 86.67%, respectively; the effective rates of the control group were 53.33%, 63.33% and 76.67%, respectively. Intra-group comparison: There was a significant difference in the total score between the two groups before treatment and after the three courses of treatment (all P<0.05); Inter-group comparison: There was no significant difference in the total score between the two groups after the first and second courses of treatment (all P>0.05), but there was a significant difference after the third course of treatment (p<0.05). Intra-group comparison: There was a significant difference in the single symptom score between the two groups before treatment and after the third course of treatment (all P<0.05); Inter-group comparison: There was a significant difference in the single score between the two groups (all P<0.05). (See Tables 9, 10, and 11 for details)

[0191] Table 9 Comparison of the efficacy of the two groups of domestic modified Kupperman scale

[0192]

[0193] Table 10 Comparison of total scores of the domestic modified Kupperman scale between the two groups

[0194]

[0195] Note: P value indicates intra-group comparison. △ : Comparison between groups before treatment; P ▲ : Comparison between groups after the first course of treatment; P ○: Comparison between groups after the second course of treatment; P ● : Comparison among groups after the third course of treatment.

[0196] Table 11 Comparison of symptom scores of the two groups in the domestic modified Kupperman questionnaire

[0197]

[0198] Note: P1 value indicates intra-group comparison, P2 value indicates inter-group comparison; P ★ <0.05, P ◆ >0.05.

[0199] 2.3 Statistics of adverse reactions between groups

[0200] There were no adverse drug reactions in both groups during the treatment.

[0201] 3. Discussion

[0202] As shown in Table 5, the scores of each factor before and after three courses of treatment in the two groups were compared, and the differences were statistically significant (p<0.05); after three courses of treatment, the six factors of PSQI in the two groups were above, and the differences were statistically significant (p<0.05). It was concluded that Shenmai Huanglian Ejiao Decoction can effectively improve sleep time, sleep duration, daytime function, sleep quality, sleep efficiency, and sleep disorders.

[0203] Conclusion Analysis: The main clinical manifestations of insomnia in menopausal syndrome are: difficulty falling asleep, shallow sleep and many dreams, easy awakening, early awakening, difficulty falling asleep after waking up, even sleepless all night, fatigue, dizziness and discomfort the next day. "Yang enters Yin" is the key to ensure normal sleep. The excess or deficiency of both Yin and Yang will lead to "Yang cannot enter Yin"; for women before and after menopause, their bodies are mostly kidney yin deficiency, because Yin deficiency cannot suppress Yang, Yang hyperactivity cannot sleep, so it can be seen that it is difficult to fall asleep, or even sleepless all night. Because the kidney controls the yin and yang of the whole body, the imbalance of yin and yang in the kidney will affect the imbalance of yin and yang in the body's internal organs, and the internal generation of virtual evil will hinder the mutual sympathy between the water and fire organs, so it can lead to interrupted sleep maintenance, easy awakening after sleeping, early awakening, and difficulty falling asleep after waking up. Because the kidney water does not go up to the heart, the heart fire cannot be nourished by the kidney water, the virtual fire disturbs the spirit, and the soul is restless, so the sleep is shallow and dreamy. Due to the deficiency of kidney essence, the marrow sea is not full, and the heart and spirit are nourished, fatigue, dizziness, tinnitus and other symptoms may occur. Therefore, the treatment should nourish kidney water, subdue heart yang, communicate yin and yang, and reduce fire and calm the mind. From the above explanation, it can be seen that Shenmai Huanglian Ejiao Decoction has the effects of nourishing kidney water to benefit heart yin, clearing heart heat to reduce heart fire, water and fire are in harmony, heart and kidney are sympathetic, yin can subdue yang, and heavy tranquilization can improve sleep time, sleep quality, sleep duration, sleep disorders, and sleep efficiency. The prescription can also replenish qi, nourish yin and blood, so it improves daytime functional disorders. Therefore, Shenmai Huanglian Ejiao Decoction can effectively improve sleep time, sleep duration, daytime function, sleep quality, sleep efficiency, and sleep disorders. At the same time, it may also be related to the fact that modern pharmacology suggests that the drugs in the prescription have the effects of prolonging total sleep time, shortening sleep time, increasing sleep efficiency, improving sleep quality, anti-fatigue, sedation and hypnosis, improving immunity, memory, and anti-inflammatory, sedative and analgesic.

[0204] As shown in Tables 6 to 11, the TCM symptoms and the domestic modified version of the two groups after three courses of treatment

[0205] The Kupperman total score and single symptom score were improved (p<0.05), and the efficacy of the treatment group was better than that of the control group. It was concluded that Shenmai Huanglian Ejiao Decoction can significantly improve the symptoms of insomnia associated with menopausal syndrome of heart-kidney disharmony.

[0206] Conclusion analysis:

[0207] The clinical efficacy of Shenmai Huanglian Ejiao Decoction on insomnia and its associated symptoms of heart-kidney disharmony type menopausal syndrome is better than Kuntai Capsule, which may be due to the fact that Shenmai Huanglian Ejiao Decoction is specially formulated for its pathogenesis and is a special prescription. Although Kuntai Capsule has the effects of nourishing yin, clearing heat, calming the mind and relieving restlessness, it is not a special medicine for this disease and is a fixed pill, which may be related to factors such as slower absorption of the drug effect than decoction.

[0208] Summary: Ding's gynecology "Shenmai Huanglian Ejiao Decoction" has the effects of nourishing yin and clearing heat, connecting the heart and kidney, nourishing the heart and calming the mind, and has a significant effect on insomnia and accompanying symptoms of heart-kidney disharmony type menopausal syndrome, and can shorten the time to fall asleep, prolong sleep time, improve sleep efficiency, improve sleep quality, sleep disorders and daytime dysfunction. At the same time, it may also be related to the effects of modern pharmacology suggesting that the prescription has estrogen-like effects, regulates neurotransmitters, calms and hypnotizes, resists fatigue, depression, and improves immunity.

[0209] 4. Conclusion

[0210] (1) Ding's Gynecology "Shenmai Huanglian Donkey-hide Gelatin Decoction" is effective in treating insomnia and its accompanying symptoms of menopausal syndrome of heart-kidney disharmony, and is superior to Kuntai Capsules.

[0211] (2) Ding's Gynecology "Ginseng, Wheat, Coptis and Donkey-hide Gelatin Soup" can effectively improve sleep onset time, sleep duration, sleep quality, sleep efficiency, sleep disorders, and daytime functional disorders, and is superior to Kuntai Capsules.

[0212] 2. Typical Clinical Cases

[0213] 1. Typical Case 1

[0214] Patient Li, female, 41 years old, was admitted to our outpatient clinic on December 25, 2024 for "reduced menstruation and unreliable sleep for more than 1 year". Current medical history: menstrual volume has decreased for more than 1 year, reduced by about 1 / 3, red color, blood clots and dysmenorrhea, accompanied by hot flashes, night sweats, poor sleep, many dreams, and easy awakening. No past history. No epidemiological history. No history of allergies.

[0215] The four diagnostic results of Traditional Chinese Medicine were: normal complexion, normal appearance, normal voice, normal breath, pale tongue, thin tongue, red tongue tip, thin yellow tongue coating, and rapid and fine pulse.

[0216] Clinical diagnosis:

[0217] TCM diagnosis: 1. Symptoms before and after menopause (heart-kidney disharmony); 2. Insomnia (heart-kidney disharmony).

[0218] Western medicine diagnosis: 1. Female menopausal syndrome; 2. Insomnia.

[0219] The treatment plan is to nourish Yin, reduce fire, and harmonize the mind.

[0220] Treatment prescription (one dose): 15g of Pseudostellaria heterophylla, 12g of Ophiopogon japonicus, 12g of Schisandra chinensis with vinegar, 30g of Ziziphus jujuba seeds, 12g of Platycladus orientalis seeds, 10g of Polygala tenuifolia with honey, 30g of mother-of-pearl, 15g of Coptis chinensis with wine, 15g of donkey-hide gelatin, 15g of Rehmannia root, 15g of Lilium, 10g of Polygonum multiflorum, 30g of Jujube, 15g of White Peony Root, and 6g of Licorice.

[0221] 5 sets of Chinese medicine, one dose per day (divided into three times), for oral administration.

[0222] After five days, the insomnia was relieved.

[0223] 2. Typical Case 2

[0224] The patient, Zhang, female, 47 years old, came to our outpatient clinic for a follow-up visit on December 25, 2024 due to "decreased menstrual flow and disturbed sleep for 5+ months".

[0225] The four diagnostic results of Traditional Chinese Medicine: normal complexion, normal appearance, normal voice, normal breath, red tongue, normal tongue body, thin white tongue coating, and normal pulse.

[0226] Clinical diagnosis:

[0227] TCM diagnosis: 1. Symptoms before and after menopause (heart-kidney disharmony); 2. Insomnia (heart-kidney disharmony).

[0228] Western medicine diagnosis: 1. Female menopausal syndrome; 2. Insomnia.

[0229] The treatment plan is to nourish Yin, reduce fire, and harmonize the mind.

[0230] Treatment prescription (one dose): 15g of Pseudostellaria heterophylla, 12g of Ophiopogon japonicus, 12g of Schisandra chinensis with vinegar, 30g of Ziziphus jujuba seeds, 12g of Platycladus orientalis seeds, 10g of Polygala tenuifolia with honey, 30g of mother-of-pearl, 15g of Coptis chinensis with wine, 15g of donkey-hide gelatin, 15g of Rehmannia root, 15g of Lilium, 10g of Polygonum multiflorum, 30g of Jujube, 15g of White Peony Root, and 6g of Licorice.

[0231] 5 sets of Chinese medicine, one dose per day (divided into three times), for oral administration.

[0232] After five days, the insomnia was relieved.

[0233] 3. Typical Case 3

[0234] The patient, Yue, female, 50 years old, was referred to our outpatient clinic on December 28, 2024 for a follow-up visit due to "8+ months of menopause and 2+ months of poor sleep." She had difficulty falling asleep, dizziness, needed to take sleeping pills, hot flashes and night sweats, good appetite, and two changes of the night shift.

[0235] Clinical diagnosis:

[0236] TCM diagnosis: 1. Symptoms before and after menopause (heart-kidney disharmony).

[0237] Western medicine diagnosis: 1. Female menopausal syndrome.

[0238] The treatment plan is to nourish Yin, reduce fire, and harmonize the mind.

[0239] Treatment prescription (one dose): 15g of Pseudostellaria heterophylla, 12g of Ophiopogon japonicus, 12g of Schisandra chinensis with vinegar, 30g of Ziziphus jujuba seeds, 12g of Platycladus orientalis seeds, 10g of Polygala tenuifolia with honey, 30g of mother-of-pearl, 15g of Coptis chinensis with wine, 15g of donkey-hide gelatin, 15g of Rehmannia root, 15g of Lilium, 10g of Polygonum multiflorum, 30g of Jujube, 15g of White Peony Root, and 6g of Licorice.

[0240] 5 sets of Chinese medicine, one dose per day (divided into three times), for oral administration.

Claims

1. A drug for treating insomnia caused by menopausal syndrome, characterized in that: The medicinal effective ingredients are calculated by weight: 50-300 parts of Pseudostellariae Radix, 40-200 parts of Radix Ophiopogonis, 40-200 parts of Fructus Schisandrae Chinensis, 150-500 parts of Semen Ziziphi Spinosae, 40-200 parts of Semen Platycladi, 30-200 parts of Polygala Tenuifolia, 150-500 parts of Mother of Pearl, 50-300 parts of Coptis Chinensis, 50-300 parts of Ejiao, 50-300 parts of Radix Rehmanniae, 50-300 parts of Lilium, 30-200 parts of Polygonum Multiflorum, 150-500 parts of Jujube, 50-300 parts of White Peony Root and 20-120 parts of Licorice.

2. The drug for treating insomnia caused by menopausal syndrome according to claim 1, characterized in that: The medicinal effective ingredients are calculated by weight: 100-200 parts of Pseudostellariae Radix, 80-160 parts of Radix Ophiopogonis, 80-160 parts of Fructus Schisandrae Chinensis, 200-400 parts of Semen Ziziphi Spinosae, 80-160 parts of Semen Platycladi, 50-150 parts of Polygala Tenuifolia, 200-400 parts of Mother of Pearl, 100-200 parts of Coptis Chinensis, 100-200 parts of Ejiao, 100-200 parts of Radix Rehmanniae, 100-200 parts of Lilium, 50-150 parts of Polygonum Multiflorum, 200-400 parts of Jujube, 100-200 parts of White Peony Root and 30-90 parts of Licorice.

3. The drug for treating insomnia caused by menopausal syndrome according to claim 1 or 2, characterized in that: The medicinal active ingredients are calculated by weight: 150 parts of Pseudostellariae Radix, 120 parts of Ophiopogon japonicus, 120 parts of Schisandrae Chinensis, 300 parts of Ziziphus jujuba seeds, 120 parts of Platycladus orientalis seeds, 100 parts of Polygala tenuifolia, 300 parts of Mother of Pearl, 150 parts of Coptis chinensis, 150 parts of donkey-hide gelatin, 150 parts of Rehmannia root, 150 parts of Lilium, 100 parts of Polygonum multiflorum, 300 parts of jujube, 150 parts of White Peony Root, and 60 parts of Licorice.

4. The drug for treating insomnia caused by menopausal syndrome according to any one of claims 1 to 3, characterized in that: For patients with menopausal syndrome and insomnia who have obvious hot flashes and night sweats, add raw dragon bone, raw oyster, Artemisia annua, tortoise shell and turtle shell to the prescription.

5. The drug for treating insomnia caused by menopausal syndrome according to any one of claims 1 to 3, characterized in that: For patients with menopausal syndrome and insomnia who suffer from obvious dizziness and tinnitus, add Uncaria rhynchophylla, Chrysanthemum, Gastrodia elata and Semen Cassiae to the prescription.

6. The drug for treating insomnia caused by menopausal syndrome according to any one of claims 1 to 3, characterized in that: For patients with menopausal syndrome and insomnia who suffer from obvious fatigue and weakness, add astragalus, codonopsis pilosula, atractylodes macrocephala, polygonatum sibiricum and jujube to the prescription.

7. The drug for treating insomnia caused by menopausal syndrome according to any one of claims 1 to 3, characterized in that: For patients with menopausal syndrome and insomnia who suffer from obvious weakness in the waist and knees, add Chuanduan, Viscum album, Psoralea corylifolia, Morinda officinalis and Eucommia ulmoides to the prescription.

8. The drug for treating insomnia caused by menopausal syndrome according to any one of claims 1 to 3, characterized in that: For patients with menopausal syndrome and insomnia who experience obvious pain and burning sensation when urinating, add Lophatherum gracile, Alisma orientale, Phellodendron chinense and Taraxacum officinale to the prescription.

9. The method for preparing the drug for treating insomnia caused by menopausal syndrome according to any one of claims 1 to 8, characterized in that: All medicinal materials in the prescription are weighed according to the proportion, and processed according to the conventional preparation method to prepare the corresponding drug preparation.

10. The method for preparing the drug for treating menopausal syndrome insomnia according to claim 9, characterized in that: The pharmaceutical preparations include decoctions, hard capsules, granules, tablets or oral liquid preparations.

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