Traditional Chinese medicine composition for treating climacteric-like symptoms as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating climacteric-like symptoms as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition comprises the following raw materials: prepared rehmannia root, Chinese yam, wine-processed fructus corni, fried spina date seed, moutan bark, gardenia, white paeony root, rhizoma alismatis, angelica sinensis, poria cocos, blighted wheat, radix bupleuri and honey-fried licorice root, and the traditional Chinese medicine composition has the effects of nourishing yin, tonifying kidney, clearing heat and soothing liver, can effectively treat climacteric-like symptoms, and almost has no influence on sex hormone level, so that the traditional Chinese medicine composition has no toxic or side effect. Compared with hormone replacement treatment medicines, the medicine is safer. Especially for tumor patients with climacteric-like symptoms after receiving ovarian function inhibition treatment, the traditional Chinese medicine composition can improve the symptoms and avoid tumor recurrence caused by estrogen fluctuation at the same time.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating perimenopausal symptoms, a preparation method thereof, and an application thereof. Background Art

[0002] Perimenopausal symptoms refer to a series of symptoms similar to those in menopause, including hot flashes and sweating, irritability and anxiety; secondary symptoms are: soreness and weakness of the waist and knees, dizziness and tinnitus, insomnia, restlessness of the mind, distending pain in the chest and hypochondrium, oliguria, dryness of the vulva, etc. The main reasons for the appearance of perimenopausal symptoms include decreased ovarian function, reduced and fluctuating hormone secretion levels, etc. For example, the endocrine treatment methods for breast cancer patients include using drugs such as ovarian function inhibitors (OFS) or luteinizing hormone-releasing hormone antagonists (LH-RHa) to treat hormone receptor-positive breast cancer by inhibiting estrogen production at the pituitary level. While this therapy brings therapeutic effects, it may also produce a series of side effects, mainly manifested as perimenopausal symptoms.

[0003] The treatment means for perimenopausal symptoms include drug treatment and non-drug treatment. Among them, hormone replacement therapy (HRT) is currently recognized as the most effective treatment method for relieving perimenopausal symptoms. However, while hormone replacement therapy drugs treat perimenopausal symptoms, there are also some potential risks and side effects. For example, they increase the risk of diseases such as breast cancer and endometrial cancer. Especially for breast cancer patients, hormone replacement therapy drugs are usually contraindicated for breast cancer women. And the choice of non-hormone treatment drugs is limited, there are problems of off-label use, and patients are prone to adverse reactions such as dry mouth, nausea, drowsiness, insomnia, and anxiety. Summary of the Invention

[0004] In view of the above technical problems, the present invention provides a traditional Chinese medicine composition for treating perimenopausal symptoms, a preparation method thereof, and an application thereof. This traditional Chinese medicine composition can significantly improve perimenopausal symptoms, and has basically no effect on sex hormone levels, and is safe and effective.

[0005] To achieve the above invention purpose, the present invention adopts the following technical solutions: In the first aspect, the present invention provides a traditional Chinese medicine composition for treating perimenopausal symptoms. The raw materials are proportioned by mass as follows: 12 - 18 parts of prepared rehmannia root, 8 - 12 parts of Chinese yam, 8 - 12 parts of fructus corni processed with wine, 12 - 18 parts of wild jujube seed stir-fried, 8 - 12 parts of moutan bark, 8 - 12 parts of gardenia fruit, 8 - 12 parts of white peony root, 8 - 12 parts of oriental water plantain rhizome, 8 - 12 parts of angelica sinensis, 8 - 12 parts of poria cocos, 24 - 36 parts of floating wheat, 8 - 12 parts of bupleurum root, and 5 - 7 parts of roasted licorice root.

[0006] Prepared rehmannia root is slightly warm in nature, sweet in taste, and belongs to the liver and kidney meridians; it nourishes blood and yin, and replenishes essence and marrow; Yam is mild in nature, sweet in taste, and enters the spleen, lung, and kidney meridians; it nourishes the spleen and stomach, promotes the production of body fluids and benefits the lungs, and nourishes the kidneys and astringes semen; Wine cornus fruit is slightly warm in nature, sour and astringent in taste, and enters the liver and kidney meridians; it nourishes the liver and kidneys, astringes the essence and strengthens the body; Fried Chinese jujube seeds are mild and slightly warm in nature, sweet and sour in taste, and enter the liver and heart meridians; they nourish the heart and liver, calm the mind, and stop sweating. Compared with raw Chinese jujube seeds, they have stronger ability to stop sweating and stop yin. Peony bark is slightly cold in nature, bitter and pungent in taste, and enters the heart, liver, and kidney meridians; it clears away heat, cools blood, and promotes blood circulation and removes blood stasis; Gardenia is cold in nature, bitter in taste, and enters the heart, lung, and triple burner meridians; it can relieve fire and relieve restlessness, clear away heat and dampness, cool blood and detoxify; White peony root is slightly cold in nature, bitter and sour in taste, and enters the liver and spleen meridians; it nourishes blood and restrains yin, softens the liver and relieves pain, and calms liver yang; Alisma orientalis is cold in nature, sweet and light in taste, and enters the kidney and bladder meridians; it promotes diuresis, eliminates dampness, relieves heat, clears turbidity and reduces lipids; Angelica sinensis is warm in nature, sweet and spicy in taste, and enters the liver meridian, heart meridian, and large intestine meridian; it replenishes blood and regulates menstruation, promotes blood circulation and relieves pain, and moistens the intestines and promotes bowel movements; Poria is mild in nature, sweet in taste, and enters the heart, spleen, kidney, and lung meridians; it promotes diuresis and reduces swelling, removes dampness, strengthens the spleen, and calms the mind; Floating wheat is cool in nature, sweet in taste, and enters the heart meridian; it strengthens the exterior and stops sweating, replenishes qi, and eliminates heat; Bupleurum is slightly cold in nature, bitter and pungent in taste, and enters the liver meridian, gallbladder meridian, and lung meridian; it can relieve coldness, soothe the liver and relieve depression, raise yang and lift sunken, reduce fever and stop malaria; Roasted licorice root is mild in nature, sweet in taste, and enters the heart, lung, spleen, and stomach meridians; it tonifies the spleen and replenishes qi, clears away heat and detoxifies, removes phlegm and relieves cough, relieves pain, and harmonizes various medicines.

[0007] This prescription uses Rehmannia glutinosa as the main medicine to nourish yin and blood, replenish essence and benefit marrow, and uses yam, Radix Angelicae Pubescentis, Bupleurum chinense, and white peony root to assist the main medicine and enhance the function of nourishing the kidney and clearing the liver. Poria cocos, stir-fried Ziziphus jujuba seeds, wine-made Cornus officinalis, and Paeonia suffruticosa rubra assist the main and minister medicines to nourish the kidney and astringe essence, purge fire and calm the mind, and use Gardenia jasminoides, Alisma orientalis, floating wheat, and roasted liquorice as the guiding medicines. The combination of the four medicines can reconcile the virtual fire inflammation caused by liver and kidney yin deficiency.

[0008] The Chinese medicine composition can effectively treat menopausal symptoms and has almost no effect on sex hormone levels, so it is safer than hormone replacement therapy drugs. In particular, for tumor patients who experience menopausal symptoms after receiving ovarian function suppression therapy, such as breast cancer patients receiving endocrine therapy, the Chinese medicine composition can improve symptoms while avoiding tumor recurrence caused by estrogen fluctuations.

[0009] Preferably, the raw materials of the traditional Chinese medicine composition are proportioned by mass parts and include: 13.5 - 16.5 parts of prepared rehmannia root, 9 - 11 parts of Chinese yam, 9 - 11 parts of cornel fruit processed with wine, 13.5 - 16.5 parts of stir-fried wild jujube seed, 9 - 11 parts of moutan bark, 9 - 11 parts of gardenia fruit, 9 - 11 parts of white peony root, 9 - 11 parts of oriental waterplantain rhizome, 9 - 11 parts of angelica sinensis, 9 - 11 parts of poria cocos, 27 - 33 parts of floating wheat, 9 - 11 parts of bupleurum root, and 5.5 - 6.5 parts of roasted licorice root.

[0010] Preferably, the raw materials of the traditional Chinese medicine composition are proportioned by mass parts and include: 15 parts of prepared rehmannia root, 10 parts of Chinese yam, 10 parts of cornel fruit processed with wine, 15 parts of stir-fried wild jujube seed, 10 parts of moutan bark, 10 parts of gardenia fruit, 10 parts of white peony root, 10 parts of oriental waterplantain rhizome, 10 parts of angelica sinensis, 10 parts of poria cocos, 30 parts of floating wheat, 10 parts of bupleurum root, and 6 parts of roasted licorice root.

[0011] In a second aspect, the present invention also provides a preparation method of the above traditional Chinese medicine composition: decoct the raw materials with water, filter, and take the filtrate to obtain the composition.

[0012] Preferably, the raw materials are soaked in water at 30 - 45 °C for 20 - 40 min before decocting. More preferably: the raw materials are soaked in water at 30 - 45 °C for 30 min before decocting.

[0013] Preferably, decoct twice. First, bring to a boil over high heat, then simmer over low heat for 30 - 40 min, filter, and take the filtrate; add water to the obtained medicinal residues, bring to a boil over high heat, then simmer over low heat for 20 - 30 min, filter, and take the filtrate; combine the filtrates to obtain the composition. More preferably: first, bring to a boil over high heat, then simmer over low heat for 35 min, filter, and take the filtrate; add water to the obtained medicinal residues, bring to a boil over high heat, then simmer over low heat for 25 min, filter, and take the filtrate; combine the filtrates to obtain the composition.

[0014] In a third aspect, the present invention also provides another traditional Chinese medicine composition for treating perimenopausal symptoms. The raw materials are proportioned by mass parts and include: 12 - 18 parts of prepared rehmannia root, 8 - 12 parts of Chinese yam, 8 - 12 parts of cornel fruit processed with wine, 12 - 18 parts of stir-fried wild jujube seed, 8 - 12 parts of moutan bark, 8 - 12 parts of gardenia fruit, 8 - 12 parts of white peony root, 8 - 12 parts of oriental waterplantain rhizome, 8 - 12 parts of angelica sinensis, 8 - 12 parts of poria cocos, 24 - 36 parts of floating wheat, 8 - 12 parts of bupleurum root, 2.4 - 3.6 parts of hypericum perforatum, 8 - 12 parts of iron filings, and 5 - 7 parts of roasted licorice root.

[0015] On the basis of the aforementioned traditional Chinese medicine composition, Hypericum perforatum and cast iron filings are added to this traditional Chinese medicine composition. Hypericum perforatum is cold in nature, pungent in flavor, and belongs to the liver meridian; it soothes the liver and relieves depression, clears heat and promotes diuresis, reduces swelling and promotes lactation; cast iron filings are cool in nature, pungent in flavor, and belong to the heart and liver meridians; they soothe the liver and suppress fright, detoxify and astringe sores, and enrich the blood. In the formula, Rehmannia glutinosa is the monarch drug, known as the "main drug for tonifying the water", greatly tonifying the true yin of the five zang-organs, fully demonstrating the "water-tonifying" effect of this formula. Dioscorea opposita and Cornus officinalis benefit the liver and kidney and tonify the spleen qi, regulating the liver and kidney simultaneously; Semen Ziziphi Spinosae nourishes the heart and soothes the mind; Paeonia lactiflora soothes the liver and astringes yin; Cornus officinalis, Semen Ziziphi Spinosae, and Paeonia lactiflora all have the meaning of astringency, showing the effect of astringing yin and stopping sweating. Cortex Moutan and Gardenia jasminoides clear heat and cool the blood, soothe the liver and purge heat. These six herbs are all ministerial drugs, harmonizing the five zang-organs, nourishing the liver and kidney, focusing on nourishing the kidney water of the lesser yin, regulating the liver function, and purging the pathogenic fire. Poria cocos and Alisma orientale promote diuresis and percolate dampness, Angelica sinensis nourishes and invigorates the blood, preventing the stagnation of yin blood, and the three herbs are used together to nourish the blood and promote diuresis simultaneously, preventing the stagnation of tonifying herbs. Fructus Tritici Levis consolidates the exterior and stops sweating, nourishes yin and astringes yin, and at the same time assists Cortex Moutan and Gardenia jasminoides in clearing heat and cooling the blood. Bupleurum chinense soothes the liver and relieves depression, Hypericum perforatum soothes the liver and relieves depression, clears heat and promotes diuresis, and the two herbs assist the heat of Cortex Moutan and Gardenia jasminoides to disperse externally. A small amount of processed Glycyrrhiza uralensis is used to replenish qi and harmonize the middle, and harmonize all the herbs. The whole formula is formulated in combination, jointly exerting the effects of nourishing yin and tonifying the kidney, clearing heat and soothe the liver.

[0016] After adding Hypericum perforatum and cast iron filings to the aforementioned traditional Chinese medicine composition, this traditional Chinese medicine composition can more effectively treat menopausal symptoms and still does not affect the sex hormone level. According to clinical statistics, for patients receiving endocrine therapy for breast cancer, the effective rate of this traditional Chinese medicine composition can reach 92.31%.

[0017] Preferably, the raw materials of the traditional Chinese medicine composition are proportioned by mass parts as follows: 13.5 - 16.5 parts of Rehmannia glutinosa, 9 - 11 parts of Dioscorea opposita, 9 - 11 parts of Cornus officinalis, 13.5 - 16.5 parts of Semen Ziziphi Spinosae, 9 - 11 parts of Cortex Moutan, 9 - 11 parts of Gardenia jasminoides, 9 - 11 parts of Paeonia lactiflora, 9 - 11 parts of Alisma orientale, 9 - 11 parts of Angelica sinensis, 9 - 11 parts of Poria cocos, 27 - 33 parts of Fructus Tritici Levis, 9 - 11 parts of Bupleurum chinense, 2.7 - 3.3 parts of Hypericum perforatum, 9 - 11 parts of cast iron filings, and 5.5 - 6.5 parts of processed Glycyrrhiza uralensis.

[0018] Preferably, the raw materials of the traditional Chinese medicine composition are proportioned by mass parts as follows: 15 parts of Rehmannia glutinosa, 10 parts of Dioscorea opposita, 10 parts of Cornus officinalis, 15 parts of Semen Ziziphi Spinosae, 10 parts of Cortex Moutan, 10 parts of Gardenia jasminoides, 10 parts of Paeonia lactiflora, 10 parts of Alisma orientale, 10 parts of Angelica sinensis, 10 parts of Poria cocos, 30 parts of Fructus Tritici Levis, 10 parts of Bupleurum chinense, 3 parts of Hypericum perforatum, 10 parts of cast iron filings, and 6 parts of processed Glycyrrhiza uralensis.

[0019] In actual clinical use, for this composition, 1 g corresponds to the weight of each weight part, and 1 - 2 doses are used every day according to the condition.

[0020] Fourth aspect, the present invention also provides a preparation method of the above traditional Chinese medicine composition: decoct the iron filings with water for 20 - 30 min, then add other raw materials and continue to decoct, filter, and take the filtrate to obtain the composition.

[0021] Preferably, the other raw materials are soaked in water at 30 - 45 °C for 20 - 40 min before decocting. More preferably, the other raw materials are soaked in water at 30 - 45 °C for 30 min before decocting.

[0022] Preferably, after adding the other raw materials, decoct twice. First, bring to a boil over high heat, then simmer over low heat for 30 - 40 min, filter, and take the filtrate; add water to the obtained medicinal residues, bring to a boil over high heat, then simmer over low heat for 20 - 30 min, filter, and take the filtrate; combine the filtrates to obtain the composition. More preferably, first bring to a boil over high heat, then simmer over low heat for 35 min, filter, and take the filtrate; add water to the obtained medicinal residues, bring to a boil over high heat, then simmer over low heat for 25 min, filter, and take the filtrate; combine the filtrates to obtain the composition.

[0023] The water consumption for decocting the iron filings first and the water consumption for soaking the other raw materials only need to be sufficient to submerge all the raw materials during the decoction extraction; during the second decoction extraction, the added water also only needs to be sufficient to submerge the raw materials.

[0024] Preferably, the preparation method further includes concentrating and / or drying the obtained water extract for easy transportation, storage, and use.

[0025] Fifth aspect, the present invention also provides the application of the above traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above preparation method, including: Application in the preparation of drugs for treating climacteric - like symptoms; Application in the preparation of drugs for treating climacteric - like symptoms in female patients who are not suitable for hormone replacement therapy drugs.

[0026] Preferably, the drug is an oral preparation, including but not limited to oral liquid, syrup, paste, powder, granule, capsule, tablet, etc.

[0027] Preferably, the above oral preparation further includes pharmaceutically acceptable excipients, such as flavoring agents, fillers, glidants, binders, disintegrants, anti - sticking agents, etc.

[0028] Preferably, the drug is for patients with climacteric - like symptoms after ovarian function suppression treatment for tumor patients. For example, the drug can be used for breast cancer endocrine therapy patients and can treat their climacteric - like symptoms without changing hormone levels. Detailed implementation manners

[0029] In order to make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the present invention will be further described in detail below in conjunction with specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

[0030] In the following examples, Rehmanniae Radix Praeparata, Dioscoreae Rhizoma, Cornus officinalis (under Cornus officinalis), Semen Ziziphi Spinosae Praeparatum (under Semen Ziziphi Spinosae), Moutan Cortex, Gardeniae Fructus, Paeoniae Radix Alba, Alismatis Rhizoma, Angelicae Sinensis Radix, Poria, Bupleuri Radix, Hyperici Perforati Herba, and Glycyrrhizae Radix Praeparata all meet the requirements of each drug item in the Chinese Pharmacopoeia (2020 Edition, Volume I). Fructus Tritici Levis and Ferrum Flos meet the requirements of each item in the Tianjin Chinese Herbal Pieces Processing Specifications (2018 Edition).

[0031] Example 1 The embodiment of the present invention provides a traditional Chinese medicine composition, which is prepared from the following raw materials per dose: 15 g of Rehmanniae Radix Praeparata, 10 g of Dioscoreae Rhizoma, 10 g of Cornus officinalis, 15 g of Semen Ziziphi Spinosae Praeparatum, 10 g of Moutan Cortex, 10 g of Gardeniae Fructus, 10 g of Paeoniae Radix Alba, 10 g of Alismatis Rhizoma, 10 g of Angelicae Sinensis Radix, 10 g of Poria, 30 g of Fructus Tritici Levis, 10 g of Bupleuri Radix, and 10 g of Glycyrrhizae Radix Praeparata.

[0032] Preparation method: Soak all the raw materials in warm water at 35-40 °C for half an hour, then decoct them twice with water. For the first decoction, first bring to a boil over high heat, and then simmer over low heat for 35 minutes, and filter to obtain the decoction; for the second decoction, add water to submerge the medicinal materials, first bring to a boil over high heat, and then simmer over low heat for 25 minutes, and filter to obtain the decoction. Mix the decoctions obtained from the two decoctions to get the finished product. Take it in the morning and evening when using.

[0033] Example 2 The embodiment of the present invention provides a traditional Chinese medicine composition, which is prepared from the following raw materials per dose: 13.5 g of Rehmanniae Radix Praeparata, 9 g of Dioscoreae Rhizoma, 9 g of Cornus officinalis, 13.5 g of Semen Ziziphi Spinosae Praeparatum, 9 g of Moutan Cortex, 9 g of Gardeniae Fructus, 9 g of Paeoniae Radix Alba, 9 g of Alismatis Rhizoma, 9 g of Angelicae Sinensis Radix, 9 g of Poria, 27 g of Fructus Tritici Levis, 9 g of Bupleuri Radix, and 5.5 g of Glycyrrhizae Radix Praeparata.

[0034] The preparation method is the same as that in Example 1.

[0035] Example 3 The embodiment of the present invention provides a traditional Chinese medicine composition for treating symptoms similar to menopause, which is prepared from the following raw materials per dose: 16.5 g of Rehmanniae Radix Praeparata, 11 g of Dioscoreae Rhizoma, 11 g of Cornus officinalis, 16.5 g of Semen Ziziphi Spinosae Praeparatum, 11 g of Moutan Cortex, 11 g of Gardeniae Fructus, 11 g of Paeoniae Radix Alba, 11 g of Alismatis Rhizoma, 11 g of Angelicae Sinensis Radix, 11 g of Poria, 33 g of Fructus Tritici Levis, 11 g of Bupleuri Radix, and 6.5 g of Glycyrrhizae Radix Praeparata.

[0036] The preparation method is the same as that in Example 1.

[0037] Example 4 An embodiment of the present invention provides a traditional Chinese medicine composition for treating climacteric-like symptoms. Each dose is made from the following raw materials: 12 g of Rehmanniae Radix Praeparata, 8 g of Dioscoreae Rhizoma, 8 g of Corni Fructus, 12 g of Ziziphi Spinosae Semen, 8 g of Moutan Cortex, 8 g of Gardeniae Fructus, 8 g of Paeoniae Radix Alba, 8 g of Alismatis Rhizoma, 8 g of Angelicae Sinensis Radix, 8 g of Poria, 24 g of Fructus Tritici Levis, 8 g of Bupleuri Radix, and 5 g of Glycyrrhizae Radix Praeparata.

[0038] Preparation method: Soak all the raw materials in warm water at 30 - 35°C for 40 min, then decoct twice with water. For the first decoction, first bring to a boil over high heat, then simmer over low heat for 40 min, and filter to obtain the decoction. For the second decoction, add water to submerge the medicinal materials, first bring to a boil over high heat, then simmer over low heat for 30 min, and filter to obtain the decoction. Mix the decoctions obtained from the two decoctions to get the product. Take it in the morning and evening when using.

[0039] Example 5 An embodiment of the present invention provides a traditional Chinese medicine composition for treating climacteric-like symptoms. Each dose is made from the following raw materials: 18 g of Rehmanniae Radix Praeparata, 12 g of Dioscoreae Rhizoma, 12 g of Corni Fructus, 18 g of Ziziphi Spinosae Semen, 12 g of Moutan Cortex, 12 g of Gardeniae Fructus, 12 g of Paeoniae Radix Alba, 12 g of Alismatis Rhizoma, 12 g of Angelicae Sinensis Radix, 12 g of Poria, 36 g of Fructus Tritici Levis, 12 g of Bupleuri Radix, and 7 g of Glycyrrhizae Radix Praeparata.

[0040] Preparation method: Soak all the raw materials in warm water at 40 - 45°C for 20 min, then decoct twice with water. For the first decoction, first bring to a boil over high heat, then simmer over low heat for 30 min, and filter to obtain the decoction. For the second decoction, add water to submerge the medicinal materials, first bring to a boil over high heat, then simmer over low heat for 20 min, and filter to obtain the decoction. Mix the decoctions obtained from the two decoctions to get the product. Take it in the morning and evening when using.

[0041] Example 6 An embodiment of the present invention provides a traditional Chinese medicine composition for treating climacteric-like symptoms. Each dose is made from the following raw materials: 15 g of Rehmanniae Radix Praeparata, 10 g of Dioscoreae Rhizoma, 10 g of Corni Fructus, 15 g of Ziziphi Spinosae Semen, 10 g of Moutan Cortex, 10 g of Gardeniae Fructus, 10 g of Paeoniae Radix Alba, 10 g of Alismatis Rhizoma, 10 g of Angelicae Sinensis Radix, 10 g of Poria, 30 g of Fructus Tritici Levis, 10 g of Bupleuri Radix, 3 g of Hyperici Perforati Herba, 10 g of Ferrum Sphaerulatum (decocted first), and 6 g of Glycyrrhizae Radix Praeparata.

[0042] Preparation method: First, decoct the iron filings in water for 25 minutes, then add the other herbs that have been soaked in warm water at 35 - 40°C for half an hour and decoct them twice. For the first decoction, bring to a boil over high heat, then reduce the heat and simmer for 35 minutes, then filter to obtain the decoction. For the second decoction, add water to cover the herbs, bring to a boil over high heat, then reduce the heat and simmer for 25 minutes, then filter to obtain the decoction. Mix the two decoctions obtained from the two decoctions, and you will get the medicine. Take it in the morning and evening when using.

[0043] Example 7 An embodiment of the present invention provides a traditional Chinese medicine composition for treating symptoms similar to menopause. Each dose is made from the following raw materials: 13.5 g of prepared rehmannia root, 9 g of Chinese yam, 9 g of cornel fruit, 13.5 g of stir-fried wild jujube seed, 9 g of moutan bark, 9 g of gardenia fruit, 9 g of white peony root, 9 g of oriental waterplantain rhizome, 9 g of Chinese angelica, 9 g of poria cocos, 27 g of floating wheat, 9 g of bupleurum root, 2.7 g of hypericum perforatum, 9 g of iron filings, and 5.5 g of roasted licorice root.

[0044] The preparation method is the same as that in Example 1.

[0045] Example 8 An embodiment of the present invention provides a traditional Chinese medicine composition for treating symptoms similar to menopause. Each dose is made from the following raw materials: 16.5 g of prepared rehmannia root, 11 g of Chinese yam, 11 g of cornel fruit, 16.5 g of stir-fried wild jujube seed, 11 g of moutan bark, 11 g of gardenia fruit, 11 g of white peony root, 11 g of oriental waterplantain rhizome, 11 g of Chinese angelica, 11 g of poria cocos, 33 g of floating wheat, 11 g of bupleurum root, 3.3 g of hypericum perforatum, 11 g of iron filings, and 6.5 g of roasted licorice root.

[0046] The preparation method is the same as that in Example 1.

[0047] Example 9 An embodiment of the present invention provides a traditional Chinese medicine composition for treating symptoms similar to menopause. Each dose is made from the following raw materials: 12 g of prepared rehmannia root, 8 g of Chinese yam, 8 g of cornel fruit, 12 g of stir-fried wild jujube seed, 8 g of moutan bark, 8 g of gardenia fruit, 8 g of white peony root, 8 g of oriental waterplantain rhizome, 8 g of Chinese angelica, 8 g of poria cocos, 24 g of floating wheat, 8 g of bupleurum root, 2.4 g of hypericum perforatum, 8 g of iron filings, and 5 g of roasted licorice root.

[0048] Preparation method: First, decoct the iron filings in water for 20 minutes, then add the other herbs that have been soaked in warm water at 30 - 35°C for 40 minutes and decoct them twice. For the first decoction, bring to a boil over high heat, then reduce the heat and simmer for 40 minutes, then filter to obtain the decoction. For the second decoction, add water to cover the herbs, bring to a boil over high heat, then reduce the heat and simmer for 30 minutes, then filter to obtain the decoction. Mix the two decoctions obtained from the two decoctions, and you will get the medicine. Take it in the morning and evening when using.

[0049] Example 10 An embodiment of the present invention provides a traditional Chinese medicine composition for treating perimenopausal symptoms. Each dose is made from the following raw materials: 18 g of prepared rehmannia root, 12 g of Chinese yam, 12 g of wine-processed dogwood fruit, 18 g of stir-fried wild jujube seed, 12 g of moutan bark, 12 g of gardenia fruit, 12 g of white peony root, 12 g of oriental waterplantain rhizome, 12 g of Chinese angelica root, 12 g of poria cocos, 36 g of floating wheat, 12 g of bupleurum root, 3.6 g of hypericum perforatum, 12 g of cast iron filings, and 7 g of roasted licorice root.

[0050] Preparation method: First, decoct the cast iron filings in water for 30 minutes, and then add the other herbs that have been soaked in warm water at 40 - 45 °C for 20 minutes and decoct twice. For the first decoction, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter to obtain the decoction. For the second decoction, add water to submerge the herbs, bring to a boil over high heat, then simmer over low heat for 20 minutes, and filter to obtain the decoction. Mix the two decoctions obtained after the two decoctions, and you will get it. Take it in the morning and evening when using.

[0051] Comparative example 1 This comparative example provides a traditional Chinese medicine composition. Each dose is made from the following raw materials: 15 g of prepared rehmannia root, 10 g of Chinese yam, 10 g of wine-processed dogwood fruit, 15 g of stir-fried wild jujube seed, 10 g of moutan bark, 10 g of gardenia fruit, 10 g of white peony root, 10 g of oriental waterplantain rhizome, 10 g of Chinese angelica root, 10 g of poria cocos, and 10 g of bupleurum root.

[0052] The preparation method is the same as that of Example 1.

[0053] Effect example 1 This effect example provides the statistical results of the clinical effects of the traditional Chinese medicine composition in Example 1 of the present invention for treating perimenopausal symptoms.

[0054] 1. Research subjects Case source: Patients aged 35 - 50 years old who had perimenopausal symptoms after endocrine therapy for breast cancer and visited the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 2022 to December 2024, a total of 78 cases. According to the actual clinical medication situation, they were divided into Treatment Group 1, Treatment Group 2, and the control group.

[0055] 2. Treatment methods Treatment Group 1: Orally take the traditional Chinese medicine composition in Example 1 of the present invention, one dose per day, taken separately in the morning and evening.

[0056] Treatment Group 2: Orally take the traditional Chinese medicine composition in Example 6 of the present invention, one dose per day, taken separately in the morning and evening.

[0057] Control group: Orally take the traditional Chinese medicine composition in Comparative Example 1 of the present invention, one dose per day, taken separately in the morning and evening.

[0058] Take continuously for 28 days.

[0059] 3. Efficacy evaluation Evaluation criteria for the curative effect of traditional Chinese medicine syndromes: Score the primary and secondary symptoms and calculate the total score of this syndrome. Finally, judge the curative effect of the syndrome according to the Nimodipine method combined with the value of the total score.

[0060] The primary symptoms are: hot flashes and sweating, irritability and anger; the secondary symptoms are: soreness and weakness of the waist and knees, dizziness and tinnitus, insomnia, restlessness of the mind, distending pain in the chest and hypochondrium, oliguria, and dryness of the genitals. The scoring criteria are shown in Table 1.

[0061] Table 1 Traditional Chinese medicine syndrome scoring

[0062] Calculation formula: [(pre-treatment score - post-treatment score) / pre-treatment score]*100%; ① Recovery: The syndrome score is reduced by >95%; ② Marked effect: 95% ≥ the reduction of the syndrome score >70%; ③ Effective: 70% ≥ the reduction of the syndrome score ≥ 30%; ④ Ineffective: The reduction of the syndrome score <30%.

[0063] The total effective rate is calculated based on the number of effective cases.

[0064] Total effective rate = (number of recovered cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0065] 4. Results of curative effect evaluation The results of curative effect evaluation of the three groups of cases are shown in Table 2 and Table 3.

[0066] Table 2 Comparison of the effective conditions before and after treatment in two groups

[0067] Note: * indicates compared with the control group, p <0.05; ** indicates compared with the control group, p <0.01. In addition, compared with Treatment Group 2, the χ 2 is 0.673, p is 0.88, with no significant difference.

[0068] 5. Comparison of sex hormone levels Compare the sex hormone levels of the three groups of cases before and after treatment, and the results are shown in Table 3.

[0069] Table 3 Comparison of sex hormone levels before and after treatment in two groups

[0070] Note: After t-test, p >0.05, and there is no significant difference in the sex hormone levels of the three groups of cases before and after treatment.

[0071] The above clinical results show that: 1. Oral administration of the traditional Chinese medicine compositions provided in Example 1, Example 6 or Comparative Example 1 of the present invention can significantly improve the menopausal-like symptoms after endocrine therapy for breast cancer ( p <0.05), and there is no statistically significant difference in the changes of sex hormone levels before and after treatment ( p >0.05).

[0072] 2. The traditional Chinese medicine compositions provided in Example 1 and Example 6 of the present invention have better curative effects in improving the Kupperman score and the integral of traditional Chinese medicine syndromes than the control group after treatment, the effective rate is significantly higher than that of the control group, and the effective rate of using the traditional Chinese medicine composition in Example 6 is higher than that of using the traditional Chinese medicine composition in Example 1.

[0073] Effect Example 2 This effect example provides a typical case of treating menopausal-like symptoms with the traditional Chinese medicine composition in Example 1 of the present invention.

[0074] Case 1: Qin, female, 52 years old, from Tianjin. The patient had hot flashes and sweating about 4 - 5 times a day in February 2022 and didn't pay attention. One month later, the sweating worsened, with involuntary hand tremors and weakness in the left limb. During the attack, there were palpitations, chest tightness, shortness of breath, and profuse sweating, which relieved in 2 minutes. Now, it occurs several times at irregular intervals every day and relieves in 5 - 15 minutes. The patient once visited the psychiatric department of the hospital and was diagnosed with an anxiety state, and was given relevant drug treatment, but the symptoms did not improve significantly after taking the medicine. Kupperman score: 36 points. The traditional Chinese medicine composition provided in Example 1 of the present invention was given for treatment, one dose a day, taken separately in the morning and evening. After taking the medicine continuously for 7 days, the frequency of the patient's hot flashes and sweating decreased significantly compared with before, the frequency of hand tremors and weakness in the left limb decreased compared with before, the degree was reduced, the relief time was shortened compared with before, the shortness of breath symptom was significantly reduced compared with before, the mood improved compared with before, the frequency of communicating with family members increased compared with before, and the sleep improved compared with before. After adjusting and nourishing with this formula for more than 3 months, the patient's symptoms basically disappeared without other discomforts, and there was no recurrence during the follow-up. Kupperman score after the course of treatment: 9 points.

[0075] Case 2: Cao, female, 51 years old, from Tianjin. The patient found a right breast tumor in August 2016 and went to the hospital for treatment. Considering right breast cancer, she underwent right mastectomy, and underwent 6 cycles of chemotherapy after surgery, without radiotherapy. After chemotherapy, the patient began to take tamoxifen orally for endocrine therapy. After breast cancer resection, the patient had intermittent hot flashes and sweating, palpitations and shortness of breath, and went to the local community hospital for treatment. Following the doctor's advice, he took Liuwei Dihuang Pills and Danshen Drop Pills without relief, and then went to several hospitals for treatment without any improvement in symptoms. The Chinese medicine composition provided in Example 1 of the present invention was given for treatment, one dose a day, divided into morning and evening. After serving for 7 consecutive days, the patient's mood was better than before, fatigue and heaviness of the lower limbs were improved, and sleep was improved. After keeping this formula for more than 1 month, the patient's hot flashes and sweating stopped, fatigue was alleviated, sleep improved, and no other discomfort was reported. There was no recurrence in the follow-up period. Kupperman score after the course of treatment: 7 points.

[0076] Effect Example 3 This effect example provides a typical case of the Chinese medicine composition in Example 6 of the present invention for treating menopausal symptoms.

[0077] Li, female, 47 years old, first diagnosed on May 28, 2024, 1 year after right breast cancer surgery. Postoperative pathology showed: right breast ductal carcinoma in situ with calcification, mainly papillary, cribriform, and comedo, nuclear grade II; ductal carcinoma in situ can be seen locally in the lower outer incision; ER90%, PR60%, HER1+~2+, Ki67 20%. Tamoxifen was taken for more than half a year after surgery. Current symptoms: clear consciousness, poor spirit, hot sweating, sweating frequency about 10 times / day, palpitations and irritability, fatigue, poor sleep, dreamy and easy to wake up, difficult to fall asleep after waking up, poor appetite, and two bowel movements. Pale tongue, white fur, deep and thin pulse. Western medicine diagnosis: postoperative breast cancer. Chinese medicine diagnosis: breast rock, various symptoms before and after menopause. Treatment is to nourish the kidney and nourish yin, soothe the liver and clear heat. Prescription: Treat with the Chinese medicine composition provided in Example 6 of the present invention, one dose a day, divided into morning and evening. The patient stopped taking the medicine after one month of continuous medication. Follow-up showed no recurrence of symptoms. The patient followed the doctor's advice and had regular checkups, and no signs of tumor recurrence or metastasis were found.

[0078] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modification, equivalent substitution or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating menopausal symptoms, characterized in that: The raw materials of the Chinese medicine composition include, by mass, 12-18 parts of Rehmannia root, 8-12 parts of Chinese yam, 8-12 parts of cornus officinalis, 12-18 parts of stir-fried Ziziphus jujuba seeds, 8-12 parts of Paeonia suffruticosa, 8-12 parts of Gardenia jasminoides, 8-12 parts of White Peony Root, 8-12 parts of Alisma orientalis, 8-12 parts of Chinese angelica, 8-12 parts of Poria, 24-36 parts of Triticum aestivum, 8-12 parts of Bupleurum chinense and 5-7 parts of Radix Glycyrrhizae Preparata.

2. The Chinese medicine composition according to claim 1, characterized in that: The raw materials of the Chinese medicine composition include, by mass, 13.5-16.5 parts of Rehmannia root, 9-11 parts of Chinese yam, 9-11 parts of cornus officinalis, 13.5-16.5 parts of stir-fried Ziziphus jujuba seeds, 9-11 parts of Paeonia suffruticosa, 9-11 parts of Gardenia jasminoides, 9-11 parts of White Peony Root, 9-11 parts of Alisma orientalis, 9-11 parts of Chinese Angelica sinensis, 9-11 parts of Poria cocos, 27-33 parts of Triticum aestivum, 9-11 parts of Bupleurum chinense and 5.5-6.5 parts of Radix Glycyrrhizae Preparata.

3. The Chinese medicine composition according to claim 2, characterized in that: The raw materials of the Chinese medicine composition include, by mass, 15 parts of Rehmannia root, 10 parts of Chinese yam, 10 parts of cornus officinalis, 15 parts of stir-fried Ziziphus jujuba seeds, 10 parts of Paeonia suffruticosa, 10 parts of Gardenia jasminoides, 10 parts of White Peony Root, 10 parts of Alisma Orientalis, 10 parts of Chinese Angelica sinensis, 10 parts of Poria, 30 parts of Triticum aestivum, 10 parts of Bupleurum chinense and 6 parts of Radix Glycyrrhizae Preparata.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The raw materials are boiled in water, filtered, and the filtrate is taken to obtain the product.

5. A Chinese medicine composition for treating menopausal symptoms, characterized in that: 12-18 parts of Rehmannia root, 8-12 parts of Chinese yam, 8-12 parts of wine-boiled cornus fruit, 12-18 parts of stir-fried Ziziphus jujuba seeds, 8-12 parts of Paeonia suffruticosa, 8-12 parts of Gardenia jasminoides, 8-12 parts of White Peony Root, 8-12 parts of Alisma Orientis, 8-12 parts of Angelica sinensis, 8-12 parts of Poria, 24-36 parts of Floating Wheat, 8-12 parts of Bupleurum, 2.4-3.6 parts of Hypericum perforatum, 8-12 parts of Tieluohua and 5-7 parts of roasted Licorice root.

6. The Chinese medicine composition according to claim 5, characterized in that: The raw materials of the Chinese medicine composition include, by mass, 13.5-16.5 parts of Rehmannia root, 9-11 parts of Chinese yam, 9-11 parts of cornus officinalis, 13.5-16.5 parts of stir-fried Ziziphus jujuba seeds, 9-11 parts of Paeonia suffruticosa, 9-11 parts of Gardenia jasminoides, 9-11 parts of White Peony Root, 9-11 parts of Alisma orientalis, 9-11 parts of Chinese Angelica sinensis, 9-11 parts of Poria cocos, 27-33 parts of Triticum aestivum, 9-11 parts of Bupleurum chinense, 2.7-3.3 parts of Hypericum perforatum, 9-11 parts of Triticum tiliaceum and 5.5-6.5 parts of Radix Glycyrrhizae Preparata.

7. The Chinese medicine composition according to claim 6, characterized in that: The raw materials of the traditional Chinese medicine composition include, by mass, 15 parts of Rehmannia root, 10 parts of Chinese yam, 10 parts of cornus fruit, 15 parts of stir-fried Ziziphus jujuba seeds, 10 parts of Paeonia suffruticosa, 10 parts of Gardenia jasminoides, 10 parts of White Peony Root, 10 parts of Alisma Orientalis, 10 parts of Angelica sinensis, 10 parts of Poria, 30 parts of Triticum tiliaceum, 10 parts of Bupleurum chinense, 3 parts of Hypericum perforatum, 10 parts of Triticum tiliaceum and 6 parts of Radix Glycyrrhizae Preparata.

8. The method for preparing the Chinese medicine composition according to any one of claims 5 to 7, characterized in that: After boiling the iron flower in water for 20-30 minutes, adding other raw materials and continuing boiling, taking the filtrate to obtain the product.

9. Use of the Chinese medicine composition according to any one of claims 1 to 3 or 5 to 7 or the Chinese medicine composition prepared by the preparation method according to claim 4 or 8, comprising: Application in the preparation of medicines for treating menopausal symptoms; Application in the preparation of a drug for treating menopausal symptoms in female patients who are not suitable for hormone replacement therapy.

10. The use according to claim 9, characterized in that: The drug is an oral preparation; and / or The drug is used for cancer patients who develop menopausal-like symptoms after receiving ovarian function suppression treatment.

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