A traditional Chinese medicine composition for treating frequent urination and incontinence in premenopausal and postmenopausal syndromes, a preparation method and applications thereof

Abstract

This invention provides a traditional Chinese medicine composition, preparation method, and application for treating frequent urination with incontinence in various postmenopausal symptoms. The traditional Chinese medicine composition, by weight, consists of the following raw materials: Astragalus membranaceus 10-20 parts, Codonopsis pilosula 10-15 parts, Atractylodes macrocephala 7.5-10 parts, Ziziphus jujuba var. spinosa 10-15 parts, Mantis religiosa ootheca 4-5 parts, Paeonia lactiflora 7.5-15 parts, Rehmannia glutinosa 6-10 parts, Angelica sinensis 7.5-10 parts, Cinnamomum cassia 1.5-2.5 parts, Poria cocos 6-7.5 parts, Lindera strychnifolia 5-6 parts, Schisandra chinensis 5-6 parts, Psoralea corylifolia 4-6 parts, Alpinia oxyphylla 4-6 parts, Citrus reticulata 4-6 parts, Polygala tenuifolia 3-4 parts, Cane sucrose (peeled) 10-30 parts, Zingiber officinale (peeled) 5-7.5 parts, Ziziphus jujuba 5-7.5 parts, and Glycyrrhiza uralensis (processed) 3-4 parts. The traditional Chinese medicine composition of the present invention has definite curative effect, is safe to use, and has no obvious toxic side effects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition, preparation method and application for treating frequent urination with incontinence in various symptoms before and after menopause. Background Technology

[0002] In *Traditional Chinese Medicine Gynecology* (4th edition, New Century, China Traditional Chinese Medicine Press), the description of "pre- and post-menopausal symptoms" is as follows: I. Definition: This refers to the symptoms experienced by women around the time of menopause, including hot flashes and sweating, irritability, flushed face, insomnia, forgetfulness, fatigue, dizziness, tinnitus, palpitations, and sometimes menstrual irregularities. Ancient medical texts do not have a dedicated section on this condition; descriptions of its symptoms can be found scattered throughout texts on conditions such as "visceral agitation," "lily disease," and "senile metrorrhagia." II. Etiology and Pathogenesis: The occurrence of this disease is closely related to the physiological characteristics of women before and after menopause. Around the age of 49, kidney qi gradually declines, the Tian Gui (menstrual blood) gradually depletes, and the Chong and Ren meridians gradually weaken, leading to the cessation of menstruation and menopause. "The kidney is the root of innate essence," and "the five viscera are interconnected; when things reach their limit, they inevitably affect the kidney." Therefore, imbalances in kidney yin and yang easily affect other organs. And diseases of other organs, over time, will inevitably affect the kidney. Thus, the root of this disease lies in the kidney, often affecting the heart, liver, spleen, and other organs, resulting in complex symptoms. It can be divided into: 1. Kidney yin deficiency, 2. Kidney yang deficiency, 3. Kidney yin and yang deficiency, 4. Heart-kidney disharmony.

[0003] III. Key Clinical Points: This disease is fundamentally rooted in kidney deficiency. An imbalance of Yin and Yang in the kidneys affects the heart, liver, and spleen, leading to a series of pathological changes and various syndromes. Clinically, kidney Yin deficiency is the most common, but due to factors such as constitution or Yin-Yang transformation, it can also manifest as kidney Yang deficiency, Yin-Yang deficiency, or disharmony between the heart and kidneys. Furthermore, due to various factors, it often involves complex pathogenesis such as Qi stagnation, blood stasis, and phlegm-dampness around menopause. This disease presents with complex syndromes, often involving a mixture of cold and heat, deficiency and excess, and affecting multiple organs; therefore, treatment should address these factors simultaneously.

[0004] The Suwen·Linglan Secret Canon Chapter says: "The bladder is the official in charge of the capital, where fluids are stored, and when the qi is transformed, they can be excreted." It also says: "The Sanjiao is the official in charge of drainage, where waterways emerge." The Suwen·Xuanming Five Qi Chapter says: "If the bladder is not functioning properly, it will cause urinary retention; if it is not functioning properly, it will cause incontinence." The Lingshu·Benshu Chapter says: "When the Sanjiao is full, it will cause urinary retention; when it is deficient, it will cause incontinence."

[0005] This disease should be differentiated from simple enuresis in minors, urinary abnormalities caused by kidney yin deficiency and fire excess and "kidney yin deficiency leading to heart-kidney disharmony" (including diabetes), urinary abnormalities caused by congenital organic or traumatic or stroke-related causes, and urinary tract infections.

[0006] Currently, Western medicine primarily treats these conditions with behavioral training, pelvic floor muscle rehabilitation, or Western medicine (such as anticholinergic drugs, which often have side effects like dry mouth and constipation). These treatments are characterized by long treatment times and limited efficacy. Surgical treatment further increases the patient's financial burden and suffering, and it is only a symptomatic treatment that does not address the root cause. In Traditional Chinese Medicine (TCM), the concept of "pre- and post-menopausal symptoms" is not specifically addressed; it is only mentioned in the main symptoms of "Kidney Yang Deficiency Syndrome" within its "differentiated treatment based on syndrome differentiation." The prescribed formula, "Yougui Wan," is a unified treatment for all symptoms of "Kidney Yang Deficiency Syndrome" and does not specifically address "frequent urination with incontinence."

[0007] Therefore, there is an urgent need for a drug that is effective, safe to use, and has no obvious toxic side effects. Summary of the Invention

[0008] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition for treating frequent urination with incontinence in various menopausal symptoms. The composition is effective in treating frequent urination with incontinence in various menopausal symptoms, is safe to use, and has no obvious toxic side effects.

[0009] Furthermore, the present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition.

[0010] Furthermore, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition.

[0011] A traditional Chinese medicine composition for treating frequent urination and incontinence in menopausal and perimenopausal symptoms, comprising the following raw materials by weight: Astragalus membranaceus 10-20 parts, Codonopsis pilosula 10-15 parts, Atractylodes macrocephala 7.5-10 parts, Ziziphus jujuba var. spinosa 10-15 parts, Mantis religiosa ootheca 4-5 parts, Paeonia lactiflora 7.5-15 parts, Rehmannia glutinosa 6-10 parts, Angelica sinensis 7.5-10 parts, Cinnamomum cassia 1.5-2.5 parts, Poria cocos 6-7.5 parts, Lindera strychnifolia 5-6 parts, Schisandra chinensis 5-6 parts, Psoralea corylifolia 4-6 parts, Alpinia oxyphylla 4-6 parts, Citrus reticulata 4-6 parts, Polygala tenuifolia 3-4 parts, Cane sucrose (peeled) 10-30 parts, Zingiber officinale (peeled) 5-7.5 parts, Ziziphus jujuba 5-7.5 parts, and Glycyrrhiza uralensis (processed) 3-4 parts.

[0012] Preferably, the traditional Chinese medicine composition for treating frequent urination with incontinence in various symptoms before and after menopause comprises, by weight: Astragalus membranaceus 12.5-20 parts, Codonopsis pilosula 12.5-15 parts, Atractylodes macrocephala 7.5-10 parts, Ziziphus jujuba var. spinosa 10-12.5 parts, Mantis religiosa ootheca 4-5 parts, Paeonia lactiflora 7.5-10 parts, Rehmannia glutinosa 6-7.5 parts, Angelica sinensis 7.5-10 parts, Cinnamomum cassia 2-2.5 parts, Poria cocos 6-7.5 parts, Lindera strychnifolia 5-6 parts, Schisandra chinensis 5-6 parts, Psoralea corylifolia 4-6 parts, Alpinia oxyphylla 4-6 parts, Citrus reticulata 4-6 parts, Polygala tenuifolia 3-4 parts, Cane sucrose (peeled) 20-30 parts, Zingiber officinale (peeled) 5-7.5 parts, Jujube 5-7.5 parts, and Glycyrrhiza uralensis (processed) 3-4 parts. Or by weight: Astragalus membranaceus 10-12.5 parts, Codonopsis pilosula 10-12.5 parts, Atractylodes macrocephala 7.5-10 parts, Ziziphus jujuba var. spinosa 12.5-15 parts, Mantis religiosa ootheca 4-5 parts, Paeonia lactiflora 10-15 parts, Rehmannia glutinosa 7.5-10 parts, Angelica sinensis 7.5-10 parts, Cinnamomum cassia 1.5-2 parts, Poria cocos 6-7.5 parts, Lindera strychnifolia 5-6 parts, Schisandra chinensis 5-6 parts, Psoralea corylifolia 4-6 parts, Alpinia oxyphylla 4-6 parts, Citrus reticulata 4-6 parts, Polygala tenuifolia 3-4 parts, Cane sugarcane (peeled) 10-20 parts, Zingiber officinale (peeled) 5-7.5 parts, Jujube 5-7.5 parts, Glycyrrhiza uralensis (processed) 3-4 parts.

[0013] More preferably, the traditional Chinese medicine composition for treating frequent urination with incontinence in various symptoms before and after menopause comprises, by weight: Astragalus membranaceus 20 parts, Codonopsis pilosula 15 parts, Atractylodes macrocephala 10 parts, Ziziphus jujuba var. spinosa 10 parts, Mantis egg case 5 parts, Paeonia lactiflora 10 parts, Rehmannia glutinosa 7.5 parts, Angelica sinensis 7.5 parts, Cinnamomum cassia 2 parts, Poria cocos 7.5 parts, Lindera strychnifolia 6 parts, Schisandra chinensis 5 parts, Psoralea corylifolia 6 parts, Alpinia oxyphylla 6 parts, Citrus reticulata 6 parts, Polygala tenuifolia 4 parts, Cane sugarcane (peeled) 25 parts, Zingiber officinale (peeled) 5 parts, Jujube 5 parts, Glycyrrhiza uralensis (processed) 3 parts.

[0014] A method for preparing the traditional Chinese medicine composition as described above: Mix the other Chinese medicinal materials except cinnamon, soak them in water, decoct them, add cinnamon halfway through, continue heating, filter out the liquid, and obtain the Chinese medicinal composition.

[0015] The amount of water added is 6-8 times the total weight of the Chinese herbal raw materials.

[0016] The specific steps of the decoction process are as follows: soak in cold water for 30 minutes, bring to a boil over high heat, simmer over low heat for 50 minutes, add cinnamon, and cook for another 10-15 minutes.

[0017] The decoction is performed 2-3 times, with 200 ml of liquid extracted each time, and the extracted liquids are then mixed together.

[0018] The application of a traditional Chinese medicine composition as described above in the preparation of a medicine for treating frequent urination and incontinence in "menopausal symptoms".

[0019] A traditional Chinese medicine preparation comprising the traditional Chinese medicine composition as described above and pharmaceutically acceptable excipients.

[0020] The medicinal properties and effects of each component in the traditional Chinese medicine composition of this invention are as follows: Astragalus: Sweet and slightly warm, it enters the spleen and lung meridians. Functions: Tonifies qi and raises yang, strengthens the defensive qi and consolidates the exterior, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves pain, promotes pus drainage and detoxification, and astringes sores and promotes tissue regeneration.

[0021] Codonopsis pilosula: Sweet, neutral. Enters the spleen and lung meridians. Functions: Tonifies the spleen and lungs, nourishes blood and generates fluids. Atractylodes macrocephala: Sweet, bitter, warm. Enters the spleen and stomach meridians. Functions: Tonifies qi and strengthens the spleen, dries dampness and promotes diuresis. Also helps with water metabolism, stops sweating, and calms the fetus.

[0022] Sour jujube seed: sour, sweet, and neutral in nature. It enters the liver, gallbladder, and heart meridians. Its functions include nourishing the heart and liver, calming the mind and soothing the nerves, astringing sweat, and promoting the production of body fluids. When using this formula, it is essential to select large, plump seeds with a purplish-red outer skin.

[0023] Mantis egg case: Sweet, salty, and neutral in nature. It enters the liver and kidney meridians. Its functions include strengthening essence and reducing urination, tonifying the kidneys and boosting yang.

[0024] White peony root: bitter, sour, and slightly cold. It enters the liver and spleen meridians. Its functions include nourishing blood and regulating menstruation, astringing yin and stopping sweating, softening the liver and relieving pain, and calming liver yang.

[0025] Rehmannia glutinosa (processed): Sweet and slightly warm. It enters the liver and kidney meridians. Its functions include nourishing blood and yin, replenishing essence and marrow.

[0026] Angelica sinensis: sweet, pungent, and warm. It enters the liver, heart, and spleen meridians. Its functions include nourishing and invigorating blood, regulating menstruation, and relieving pain.

[0027] Cinnamon: pungent, sweet, and very hot in nature. It enters the kidney, spleen, heart, and liver meridians. Its functions include tonifying fire and assisting yang, dispelling cold and relieving pain, warming and unblocking the meridians, and guiding fire back to its source. In this formula, it is used in its whole form; it should never be ground into powder.

[0028] Poria cocos: Sweet, bland, and neutral in nature. It enters the heart, lung, spleen, and kidney meridians. Its functions include promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind and spirit.

[0029] Lindera root: pungent, warm. It enters the lung, spleen, kidney, and bladder meridians. Its functions include promoting qi circulation and relieving pain, warming the kidneys and dispelling cold.

[0030] Schisandra chinensis: Sour, sweet, and warm in nature. It enters the lung, heart, and kidney meridians. Its functions include astringing and consolidating, replenishing qi and generating fluids, tonifying the kidneys and calming the mind. In this formula, Schisandra chinensis is processed with wine, which enhances its kidney-tonifying effects while simultaneously astringing the lungs.

[0031] Psoralea corylifolia: pungent, bitter, and warm. It enters the kidney and spleen meridians. Functions: tonifies the kidneys and strengthens yang; consolidates essence and reduces urination; regulates qi and relieves asthma; warms the spleen and stops diarrhea; externally used to dispel wind and remove blemishes. In this formula, Psoralea corylifolia is stir-fried with salt water to enhance its effect of entering the kidneys and tonifying the gate of life (mingmen).

[0032] Alpinia oxyphylla: pungent, warm. Enters the spleen and kidney meridians. Functions: warms the kidneys, consolidates essence, reduces urination, warms the spleen, stops diarrhea, and reduces salivation. In this formula, Alpinia oxyphylla is stir-fried with salt water to guide the medicine to the kidneys, enhancing its effects of warming the kidneys, consolidating qi, and astringing essence.

[0033] Dried tangerine peel: bitter, pungent, and warm. It enters the spleen and lung meridians. Its functions include regulating qi and strengthening the spleen, drying dampness and resolving phlegm.

[0034] Polygala tenuifolia: Bitter, pungent, and warm. It enters the heart, kidney, and lung meridians. Functions: Calms the mind and improves intelligence, harmonizes the heart and kidneys, eliminates phlegm and opens the orifices, and reduces carbuncles and swellings. Processed Polygala tenuifolia is used in this formula.

[0035] Purple sugarcane: Sweet, neutral, slightly warm. It enters the lung, spleen, and stomach meridians. Functions: Tonifies qi and blood, strengthens the spleen and harmonizes the stomach, relieves cough and strengthens the stomach. Fresh purple sugarcane, peeled, must be used in this formula.

[0036] Ginger: pungent, slightly warm. It enters the lung, spleen, and stomach meridians. Red dates: Sweet and warm in nature. They enter the spleen, stomach, and heart meridians. Their functions include tonifying the middle energizer and replenishing qi, nourishing blood and calming the mind.

[0037] Licorice: Sweet, neutral. Enters the heart, lung, spleen, and stomach meridians. Functions: Tonifies the spleen and replenishes qi (when honey-processed), clears heat and detoxifies, resolves phlegm and relieves cough, alleviates spasms and pain, and harmonizes other herbs. The formula uses processed licorice (red peel).

[0038] Note: The preparation methods for all the above-mentioned herbs are based on the "Hunan Province Standard for Processing Chinese Medicinal Materials" compiled by the Hunan Provincial Health Department and published by Hunan Science and Technology Press in 1983.

[0039] The principle of medication of this invention is as follows: This invention is based on the concepts of "pre- and post-menopausal symptoms," "etiology and pathogenesis," "differentiation and treatment," and "clinical key points" in *Traditional Chinese Medicine Gynecology* (New Century Fourth Edition, China Traditional Chinese Medicine Press). Combining these with the main symptom characteristics observed before and after menopause, this invention primarily targets the treatment of frequent urination accompanied by incontinence (most commonly leakage, less frequent enuresis) caused by "deficiency of both kidney yin and yang" with a focus on "kidney yang deficiency" before and after menopause, involving deficiency of lung and spleen qi, deficiency of heart and liver yin and blood, malnourishment of the heart, disharmony between the heart and kidneys, and concurrent liver qi stagnation, leading to bladder dysfunction. This invention has the following five major innovative points, which are described below: 1. As an important supplement to the "Examples of Syndromes" in the concept of "Symptoms Before and After Menopause". In clinical practice, kidney yin deficiency is indeed the most common syndrome before and after menopause. Therefore, most of the examples in the concept describe the syndrome of kidney yin deficiency. However, frequent urination accompanied by incontinence (mostly leakage of urine, and less common enuresis) is very common in this age group. The course of the disease is long and the treatment is often unsatisfactory, which has become a major problem for patients. In order to draw sufficient attention to this, this invention believes that it is necessary to add this syndrome to the description of the concept.

[0040] 2. In terms of syndrome differentiation and treatment, this invention establishes that before and after menopause, "kidney yang deficiency" manifests against the backdrop of "kidney yin deficiency." "At the age of forty-seven, kidney qi gradually declines, the Tian Gui (menstrual blood) gradually depletes, and the Chong and Ren meridians gradually weaken..." This establishes that this invention avoids excessively pungent, hot, and drying warming yang herbs (such as aconite) in treatment to prevent the risk of "damaging yin and causing internal heat." Although a very small amount of cinnamon (also very hot) is used in the formula, its role as the principal herb for "warming the kidney and tonifying yang" is minimal. Therefore, its drying and drying properties are relatively mild, only slightly igniting the fire of the gate of life (guiding the fire back to its origin). Most importantly, it utilizes its ability to enter the liver meridian, playing a crucial adjuvant role, which aconite cannot possess.

[0041] 3. In terms of treatment principles, this invention starts from the holistic dialectical thinking and implements the principle of regulating the five internal organs of heart, liver, spleen, lungs and kidneys. It focuses on regulating the Qi of the spleen, lungs and kidneys, and uses nourishing Yin and blood, nourishing the heart and calming the mind, and astringing the lungs as auxiliary methods. It is combined with methods of soothing the liver and regulating Qi, harmonizing the heart and kidneys, and unblocking the triple burner, so that the functions of the five internal organs can be restored, the Qi of the whole body and the metabolism of water and fluids can be normalized, the Yin and Yang of the kidneys can reach a new and higher level of balance, the Qi transformation and retention capacity of the kidneys can be strengthened and consolidated, and the bladder can open and close properly and retain urine effectively, thereby achieving normal urination.

[0042] 4. Specific treatment measures mainly revolve around the coordinated operation of the five internal organs in the body's Qi circulation and fluid metabolism. Although the direct location of urinary frequency and incontinence is the bladder, the bladder's restraining power (controlling ability) depends on the coordinated function of the five internal organs. The specific principles are as follows: ① Kidney (core): governs storage and controls urination and defecation. The kidney is the foundation of innate constitution and the driving force for controlling urination; sufficient kidney Qi is necessary for the normal opening and closing of the bladder. If kidney Qi is deficient, the storage capacity is weak, leading to urinary frequency or incontinence. ② Spleen (middle support): governs transportation and transformation and the ascending of clear Qi. The spleen is the foundation of acquired constitution, responsible for transporting nutrients and maintaining the position of internal organs; spleen Qi deficiency and sinking of middle Qi not only fail to control water passages but also cause the bladder to shift downwards (organ prolapse). ③ Lung (upper reaches): governs dispersing and descending Qi, regulates water metabolism, and controls water passages. The lung is the upper source of water, responsible for distributing body fluids throughout the body; insufficient lung Qi, on the one hand, "the upper body is deficient and cannot control the lower body," and on the other hand, water flows directly downwards, both leading to loss of control over the opening and closing of the bladder. ④ The liver (pivot point) governs the free flow of Qi and regulates its movement. The liver's meridian encircles the genitals; stagnation of liver Qi can affect bladder Qi transformation, and damp-heat descending through the liver meridian can interfere with the bladder's normal function. ⑤ The heart (ruler) governs the mind and connects to the small intestine. The heart is the sovereign organ, governing consciousness. Loss of mental control during sleep, or excessive heart fire descending to the small intestine, can both cause urinary abnormalities.

[0043] Cinnamon, Psoralea corylifolia, Alpinia oxyphylla, and Mantis egg case: warm and tonify kidney yang, strengthen the body's ability to retain fluids; Rehmannia glutinosa nourishes yin and blood, replenishes essence and marrow; the combination of these two herbs "seeks yang within yin," and "yang receives the assistance of yin, generating endless vitality." Astragalus membranaceus, Codonopsis pilosula, and Atractylodes macrocephala tonify spleen yang, lift prolapsed qi, and strengthen the body's ability to retain fluids; they also tonify lung qi and enhance its ability to retain fluids. The combination of these three herbs warms kidney yang to assist spleen yang (tonifying fire to generate earth), tonifies the spleen to generate lung qi (strengthening earth to generate metal), and strengthens the kidneys to receive lung qi (metal and water mutually generating each other), enabling the lungs, spleen, and kidneys to play a vital role in the "up and down movement of qi and fluid metabolism throughout the body," serving as the principal herbs.

[0044] Angelica sinensis and Paeonia lactiflora enter the liver meridian and nourish liver blood. Paeonia lactiflora also nourishes and softens the liver, working in conjunction with Cinnamomum cassia (which also enters the liver meridian), the chief herb, to maintain the liver's function of dispersing and regulating Qi. Because the liver is "yin in substance but yang in function," it needs yin blood as its material basis and the warming and dispersing effect of yang Qi, thus ensuring that the liver plays a good "pivotal" role in the overall Qi movement and fluid metabolism. Schisandra chinensis and Ziziphus jujuba var. spinosa both enter the heart meridian. Schisandra chinensis mainly astringes and consolidates, invigorates Qi and generates fluids, and calms the mind, tending to "absorb" heart Qi and heart Yin to prevent dissipation; Ziziphus jujuba var. spinosa nourishes the heart and liver, calms the mind, and focuses on "nourishing" heart blood and liver blood. Together, they astringe and nourish, jointly shouldering the role of governing consciousness in the overall Qi movement and fluid metabolism. (Note: Schisandra chinensis can also enter the lung and kidney meridians, astringing lung Qi and tonifying kidney essence, working in conjunction with the chief herb.) Purple sugarcane is sweet and slightly warm in nature, and it enters the spleen, lung, and stomach meridians. It invigorates qi and nourishes blood, strengthens the spleen and harmonizes the middle jiao, providing acquired energy to the spleen and stomach to nourish the innate kidneys. All of the above are considered assistant herbs.

[0045] Poria cocos enters the spleen meridian, strengthening the spleen and eliminating dampness; dried tangerine peel regulates qi and invigorates the spleen. Adding dried tangerine peel to a large group of qi-tonifying and blood-nourishing herbs can promote qi circulation and prevent the tonifying herbs from being too rich and cloying, thus achieving tonification without stagnation; ginger and red dates harmonize the spleen and stomach. The combination of these four ingredients ensures the smooth flow of qi in the middle jiao (middle burner).

[0046] Cinnamon, its most notable characteristic is its entry into the liver meridian, guiding other herbs into the blood. The liver stores blood and governs its free flow; when cold pathogens invade the liver meridian, causing stagnation of qi and blood, cinnamon guides the qi- and blood-tonifying herbs in the formula into the liver meridian, acting as a guide and playing a vital role. Polygala tenuifolia: This herb is bitter, pungent, and warm in nature, entering the heart, kidney, and lung meridians. Its nature is excellent at dispersing and unblocking, opening the heart qi and opening the orifices, as well as unblocking the kidney qi and storing essence, essentially building a bridge between the heart and kidneys, facilitating communication between them. Lindera strychnifolia: Pungent and warm, entering the lung, spleen, kidney, and bladder meridians, it excels at promoting qi circulation and dispelling cold, like a warm lamp illuminating the energy pathways of the whole body (especially the lower jiao), dispelling cold stagnation through warmth and allowing qi to flow smoothly between the three jiaos. The above seven herbs, combined, serve as adjuvants, "soothing the liver and regulating qi, connecting the heart and kidneys, and unblocking the three jiaos," and play a crucial role in maintaining the dynamic balance of qi circulation and fluid metabolism throughout the body. Prepared licorice root tonifies the spleen and replenishes qi, and harmonizes the effects of other herbs.

[0047] Compared with the prior art, the traditional Chinese medicine composition for treating frequent urination and incontinence in various symptoms before and after menopause provided by the present invention is composed of the following raw materials by weight: Astragalus membranaceus 10-20 parts, Codonopsis pilosula 10-15 parts, Atractylodes macrocephala 7.5-10 parts, Ziziphus jujuba var. spinosa 10-15 parts, Mantis religiosa ootheca 4-5 parts, Paeonia lactiflora 7.5-15 parts, Rehmannia glutinosa 6-10 parts, Angelica sinensis 7.5-10 parts, Cinnamomum cassia 1.5-2.5 parts, Poria cocos 6-7.5 parts, Lindera strychnifolia 5-6 parts, Schisandra chinensis 5-6 parts, Psoralea corylifolia 4-6 parts, Alpinia oxyphylla 4-6 parts, Citrus reticulata 4-6 parts, Polygala tenuifolia 3-4 parts, Cane sucrose (peeled) 10-30 parts, Zingiber officinale (peeled) 5-7.5 parts, Jujube 5-7.5 parts, and Glycyrrhiza uralensis (processed) 3-4 parts.

[0048] This invention primarily targets the pathogenesis of the disease, specifically the premenopausal period, which is characterized by "deficiency of both kidney yin and yang," with a predominance of "kidney yang deficiency." This involves lung and spleen qi deficiency, heart and liver yin and blood deficiency, resulting in malnourishment of the heart, disharmony between the heart and kidneys, and concurrent liver qi stagnation, leading to bladder dysfunction. The disease typically occurs between the ages of 40 and 60, with a relatively high incidence and a long course, ranging from a few months to several months or even years. Main symptoms include: delayed menstruation; general cold intolerance, cold extremities, irritability, insomnia, palpitations, and vivid dreams (ranging from mild to severe); frequent urination at night, especially on rainy days, with increased frequency, clarity, volume, and painlessness; urinary leakage (in varying amounts) when coughing, sneezing, laughing, walking, or experiencing emotional stress; a large, pale tongue with a thin white or slippery white coating, teeth marks on the edges, and in rare cases, a slightly red tip; and a deep, thready, and slow pulse. The treatment is effective, safe, and has no significant toxic side effects. Detailed Implementation

[0049] To enable those skilled in the art to better understand the technical solutions in this application, the technical solutions in the embodiments of this application will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0050] The raw materials used in this invention are sourced from the following sources: The Chinese medicines mentioned above are all processed medicinal slices, provided by Hunan Futai Chinese Medicine Slices Co., Ltd.

[0051] Example 1 A traditional Chinese medicine composition for treating frequent urination accompanied by incontinence (most commonly leakage of urine, less common enuresis) in "premenopausal symptoms" is made from the following raw materials in the indicated weight ratios: Astragalus membranaceus 40g, Codonopsis pilosula 30g, Atractylodes macrocephala 20g, Ziziphus jujuba var. spinosa 20g, Mantis religiosa ootheca 10g, Paeonia lactiflora 20g, Rehmannia glutinosa 15g, Angelica sinensis 15g, Cinnamomum cassia 4g, Poria cocos 15g, Lindera strychnifolia 12g, Schisandra chinensis 10g, Psoralea corylifolia 12g, Alpinia oxyphylla 12g, Citrus reticulata 12g, Polygala tenuifolia 8g, Cane sugarcane (peeled) 50g, Zingiber officinale (peeled) 10g, Jujube 10g, Glycyrrhiza uralensis (processed) 6g.

[0052] The preparation method is as follows: Mix the raw materials (except for cinnamon, which should be added later, after simmering over low heat for 40-50 minutes. Note: Do not grind the cinnamon into powder, mainly to prevent excessive loss of its active ingredients such as cinnamaldehyde and other volatile oils. The Chinese Pharmacopoeia stipulates that this product contains not less than 1.2% (mL / g) of volatile oil and not less than 1.5% of cinnamaldehyde (C9H8O)). Add water equal to 7 times the total weight of the raw materials, soak in cold water for 30 minutes, bring to a boil over high heat, simmer over low heat for 50 minutes, add cinnamon, and boil for another 10 minutes. Decoct twice, and pour out about 200 ml of the decoction after each decoction. Mix the decoctions and take them warm twice a day, morning and evening. Do not eat onions or radishes when taking the medicine. Purple sugarcane must be kept fresh. If the core turns red or rots, it must not be used in the medicine.

[0053] Example 2 A traditional Chinese medicine composition for treating frequent urination accompanied by incontinence (most commonly leakage of urine, less common enuresis) in "premenopausal symptoms" is made from the following raw materials in the indicated weight ratios: Astragalus membranaceus 20g, Codonopsis pilosula 25g, Atractylodes macrocephala 20g, Ziziphus jujuba var. spinosa 30g, Mantis religiosa ootheca 10g, Paeonia lactiflora 30g, Rehmannia glutinosa 20g, Angelica sinensis 15g, Cinnamomum cassia 3g, Poria cocos 15g, Lindera strychnifolia 12g, Schisandra chinensis 12g, Psoralea corylifolia 12g, Alpinia oxyphylla 12g, Citrus reticulata 12g, Polygala tenuifolia 8g, Cane sugarcane (peeled) 30g, Zingiber officinale (peeled) 10g, Jujube 10g, Glycyrrhiza uralensis (processed) 6g.

[0054] The preparation method is as follows: Mix the raw materials (except for cinnamon, which should be added later, after simmering over low heat for 40-50 minutes. Note: Do not grind the cinnamon into powder, mainly to prevent excessive loss of its active ingredients such as cinnamaldehyde and other volatile oils. The Chinese Pharmacopoeia stipulates that this product contains not less than 1.2% (mL / g) of volatile oil and not less than 1.5% of cinnamaldehyde (C9H8O)). Add water equal to 6 times the total weight of the raw materials, soak in cold water for 30 minutes, bring to a boil over high heat, simmer over low heat for 50 minutes, add cinnamon, and boil for another 15 minutes. Decoction is repeated 3 times. Each time, about 200 ml of decoction is poured out. Mix the decoctions and take them warm twice a day, morning and evening. Do not eat onions or radishes when taking the medicine. Purple sugarcane must be kept fresh. If the core turns red or rots, it is not allowed to be used in the medicine.

[0055] Example 3 Prepare materials according to the raw materials and proportions shown in Table 1.

[0056] The preparation method is as follows: Mix the raw materials (except for cinnamon, which should be added later, after simmering over low heat for 40-50 minutes. Note: Do not grind the cinnamon into powder, mainly to prevent excessive loss of its active ingredients such as cinnamaldehyde and other volatile oils. The Chinese Pharmacopoeia stipulates that this product contains not less than 1.2% (mL / g) of volatile oil and not less than 1.5% of cinnamaldehyde (C9H8O)). Add water equal to 8 times the total weight of the raw materials, soak in cold water for 30 minutes, bring to a boil over high heat, simmer over low heat for 50 minutes, add cinnamon, and boil for another 10 minutes. Decoct twice, and pour out about 200 ml of the decoction after each decoction. Mix the decoctions and take them warm twice a day, morning and evening. Do not eat onions or radishes when taking the medicine. Purple sugarcane must be kept fresh. If the core turns red or rots, it is not allowed to be used in the medicine.

[0057] Comparative Examples 1-4 Prepare the materials according to the raw materials and proportions shown in Table 1. The preparation method, fasting conditions, and precautions are the same as in Example 1.

[0058] Table 1 Formulations of Examples and Comparative Examples

[0059] Comparative Examples 5-7 Comparative Example 5 represents "Buzhong Yiqi Tang" plus Psoralea corylifolia, Cuscuta chinensis, and Alpinia oxyphylla; namely: Astragalus membranaceus 40g, Atractylodes macrocephala 20g, Citrus reticulata 12g, Cimicifuga foetida 5g, Bupleurum chinense 12g, Codonopsis pilosula 30g, Glycyrrhiza uralensis 6g, Angelica sinensis 15g, Psoralea corylifolia 12g, Cuscuta chinensis 15g, and Alpinia oxyphylla 12g.

[0060] Comparative Example 6 represents the "Yougui Wan" formula for treating kidney yang deficiency syndrome in the "Menopausal Syndromes" section of "Traditional Chinese Medicine Gynecology" (New Century Fourth Edition, China Traditional Chinese Medicine Press); namely, prepared aconite 8g, cinnamon 5g, cornus officinalis 12g, eucommia ulmoides 20g, prepared rehmannia glutinosa 15g, prepared licorice root 6g, yam 20g, and wolfberry 15g.

[0061] Comparative Example 7: Based on the "Erxian Decoction" in the "Menopausal Symptoms" section of "Traditional Chinese Medicine Gynecology" (New Century Fourth Edition, China Traditional Chinese Medicine Press), which is used to treat deficiency of both Yin and Yang of the kidneys, Codonopsis pilosula and Astragalus membranaceus are added; namely, Curculigo orchioides 5g, Epimedium brevicornu 10g, Morinda officinalis 10g, Angelica sinensis 15g, Phellodendron chinense 12g, Anemarrhena asphodeloides 12g, Codonopsis pilosula 30g, and Astragalus membranaceus 40g.

[0062] Comparative Examples 5, 6, and 7 all used prepared medicinal slices (provided by Hunan Futai Traditional Chinese Medicine Slices Co., Ltd.). For Comparative Example 6, the preparation method requires attention: For the first decoction, add an appropriate amount of water to the prepared aconite root and decoct for 1 hour. Then add all the other herbs except for cinnamon, simmer over low heat for 50-60 minutes, then add the cinnamon chunks and decoct for another 10-15 minutes. The remaining decoction steps are the same as in this invention. For Comparative Examples 5 and 6, onions are prohibited during the treatment period. For Comparative Example 6, radishes are prohibited during the treatment period. Comparative Example 7 has no special dietary restrictions.

[0063] Test case 1. From April 2017 to March 2026, 128 patients with frequent urination and incontinence before and after menopause were treated.

[0064] 2. Diagnostic criteria Based on the general overview of "premenopausal symptoms" in *Traditional Chinese Medicine Gynecology* (New Century Fourth Edition, China Traditional Chinese Medicine Press), and considering the etiology and pathogenesis primarily addressed in this invention, the premenopausal period is characterized by "deficiency of both kidney yin and yang," with "kidney yang deficiency" being the primary factor. This involves deficiency of lung and spleen qi, deficiency of heart and liver yin and blood, malnourishment of the heart, disharmony between the heart and kidneys, and concurrent liver qi stagnation, leading to bladder dysfunction. The onset age is mostly between 40 and 60 years old, with a relatively high incidence rate and a long course, ranging from a few months to several months or even years. Main symptoms: delayed menstruation; feeling cold and having cold limbs; irritability, insomnia, palpitations, and vivid dreams (ranging from mild to severe); frequent urination at night, especially on rainy days, with clear, copious, and painless urination; leakage of urine when coughing, sneezing, laughing, walking, or during emotional stress (the amount may vary); a relatively large tongue with a pale white body, a thin white or slippery white coating, teeth marks on the edges, and in rare cases, a slightly red tip; and a deep, thready, and slow pulse. Diagnosis is based on these characteristics and differential diagnosis.

[0065] The symptoms targeted by this invention should be differentiated from simple enuresis in minors, urinary abnormalities caused by "kidney yin deficiency and fire excess" and "kidney yin deficiency leading to heart-kidney disharmony" (including diabetes), urinary abnormalities caused by congenital organic or traumatic or stroke-related causes, and urinary tract infections.

[0066] 3. Treatment methods One dose per day, each dose decocted 2-3 times, each time yielding about 200 ml of liquid. Mix the decocted liquids together and take warm once in the morning and once in the evening. 7-10 doses constitute one course of treatment.

[0067] 4. Efficacy evaluation criteria 1) Cured: Menstrual cycle is normal; limbs are warm and there is no obvious feeling of coldness in the body; sleep is normal; nocturia is 0-1 times a night and is not affected by the weather; there is no leakage of urine when abdominal pressure increases, such as when coughing, and it is not affected by mental factors. The tongue is normal, pale red, with a thin white coating, and the teeth marks on the sides of the tongue have significantly improved or disappeared. The tip of the tongue is not red. The pulse is deep, slow, and forceful.

[0068] 2) Effective: Reduced number of days of delayed menstrual cycle; reduced symptoms of cold intolerance and cold extremities; improved sleep; reduced frequency of urination at night, with no significant impact on urination on rainy days; reduced frequency or volume of urinary incontinence when abdominal pressure increases, such as during coughing; tongue is larger or normal in size, with a pale white or pale red tongue body, a thin white or slippery white coating, reduced teeth marks on the sides, and the original red tip of the tongue is less noticeable; deep and slow pulse.

[0069] 3) Ineffective: There is no improvement in any of the main symptoms of the disease.

[0070] 4) Overall effective rate = (number of cured + effective cases) / total number of cases x 100%.

[0071] 5) Treatment effect: 128 patients, including 45 patients in experimental case 1, 38 patients in experimental case 2, and 45 patients in experimental case 3. Generally, 1-2 courses of treatment were used, and some patients took three courses of treatment. The total effective rate reached 100%, and the cure rates were 91.1%, 89.5%, and 86.6%, respectively.

[0072] Table 2 Comparison of treatment effects between the examples and comparative examples

[0073] Typical Case Data 1. Ms. Duan, 47 years old, from Lianggong, gestation 1, para 1, 5 years post-thyroid cancer surgery, tubal ligation. First visit on January 20, 2026. Menstrual cycle 30-32 days, with small blood clots, clearing in 3 days. However, she experienced lower abdominal distension and back pain on the first and second days of menstruation. She also experienced coldness in her lower back and feet, frequent urination, and urinary incontinence with coughing for over 2 years, each time soaking a large portion of her shorts and outer trousers. She was easily awakened during sleep, had normal bowel movements, a pale white tongue with a thin white coating and teeth marks on the edges, and a deep, thready pulse. She was prescribed Experimental Case 1 of this invention (10 doses). Follow-up visit on January 30, 2026. She reported that urination frequency was basically normal, with only slight leakage when coughing, and significant improvement in the coldness in her lower back and feet. Her tongue was pale red with a thin white coating, and her pulse was deep, slow, and relatively strong. She was again prescribed Experimental Case 1 of this invention (10 doses). A follow-up phone call one month later confirmed complete recovery.

[0074] 2. Ms. Li, 46 years old, from Loudi, gestation 1 (IVF), first visit on February 9, 2026. She had irregular menstruation, with a cycle of 3-4 months. She experienced frequent urination, with urinary incontinence during coughing, running, or lifting heavy objects, and had been experiencing excessive urination for 5-6 years, worsening in the last 2 years. She was particularly sensitive to cold on the outer thighs and buttocks, without hot flashes, sweating, or dry mouth. She had poor sleep quality and 1-2 bowel movements per day, sometimes with loose stools. Her tongue was pale with a white, slippery coating, and her pulse was deep, thready, and slow, with an extremely thin pulse in the right cun position. She was given experimental case 3 of this invention (10 doses). She returned for a follow-up visit on February 26, 2026, reporting that urination frequency had returned to normal, urinary incontinence during coughing had significantly improved (only occasionally leaking a small amount during pulsation), and there was no longer significant coldness on the outer thighs and buttocks. Her sleep had improved. Her tongue was pale with a thin white coating, and her pulse was deep and slow, with a deep and forceful pulse in the right cun position. She was again given experimental case 3 of this invention (10 doses). The patient returned for a follow-up visit on March 16, 2026, reporting that urination frequency was normal, there was no longer any urinary incontinence, and the buttocks and outer thighs felt warm.

[0075] 3. Ms. Xie, female, 60 years old, from Xiaobi, Loudi, first visited on June 9, 2024. She had a history of hypertension and complained of frequent urination, especially nocturia (3-4 times a day), with large, clear urine. She had also experienced urinary incontinence while walking for two years, requiring 2-3 diapers daily. Treatment at various locations had been ineffective. She also experienced irritability and insomnia. Her tongue was pale with a thin, white coating, and the tip was slightly red. Her pulse was deep and thready. She was given Experimental Case 2 of this invention (10 doses). She returned for a follow-up visit on June 29, 2024. She reported that her urination frequency was basically normal, and she could walk over 10,000 steps daily without urinary incontinence. Her sleep had significantly improved. Her tongue was pale with a thin white coating, and the tip was not red. Her pulse was deep, slow, and forceful. She was given Experimental Case 1 of this invention (10 doses). She has been followed up for two years without recurrence.

[0076] 4. Ms. Zhang, 57 years old, from Wanbao Town, Loudi, first visited on September 25, 2025. She had been postmenopausal for 8 years, had lower abdominal distension, had urinary incontinence when coughing for more than a year, mild uterine prolapse, cold lower back, and easy awakening during sleep. Her tongue was pale with a thin white coating, and her pulse was deep and thready. She was given Experimental Case 1 of this invention (10 doses). She returned for a follow-up visit on October 4, 2025, and all the above symptoms had improved. She was given Experimental Case 3 of this invention (10 doses). She returned for a follow-up visit on October 15, 2025, and reported that her urination was normal, her urinary incontinence had been cured, and her sleep was normal.

[0077] 5. Ms. Xiao, 70 years old, from Xiangtan, with a history of hypertension and currently taking antihypertensive medication, first visited on May 13, 2024. She complained of frequent urination and large urine volume since childhood, approximately 20 times / day and 8 times / night. She also experienced unpredictable wet urination 3 times a month during the day (without her knowledge, and currently still does this once a month). Each time, the urine volume was large, without pain, dry mouth, but no hot flashes or sweating. She had poor sleep, was not sensitive to cold, had a pale red tongue with a thin white coating, a deep and large pulse on the left and right cun positions, and a deep and thready pulse on both guan and chi positions. She was given experimental case 1 of this invention (10 doses). On May 30, 2024, her sister informed her that her condition had improved, but due to inconvenience in visiting the doctor, no medication was prescribed. On February 6, 2026, a follow-up visit was conducted by phone. The daytime urinary frequency had resolved, with only slightly more frequent nighttime urination (2-3 times), and occasional light wetting of the bladder.

[0078] The above description is merely an embodiment of the present invention. It should be noted that those skilled in the art can make improvements without departing from the inventive concept of the present invention, but these improvements all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating frequent urination accompanied by incontinence in various symptoms around menopause, characterized in that: By weight, it is composed of the following raw materials: Astragalus membranaceus 10-20 parts, Codonopsis pilosula 10-15 parts, Atractylodes macrocephala 7.5-10 parts, Ziziphus jujuba var. spinosa 10-15 parts, Mantis religiosa ootheca 4-5 parts, Paeonia lactiflora 7.5-15 parts, Rehmannia glutinosa 6-10 parts, Angelica sinensis 7.5-10 parts, Cinnamomum cassia 1.5-2.5 parts, Poria cocos 6-7.5 parts, Lindera strychnifolia 5-6 parts, Schisandra chinensis 5-6 parts, Psoralea corylifolia 4-6 parts, Alpinia oxyphylla 4-6 parts, Citrus reticulata 4-6 parts, Polygala tenuifolia 3-4 parts, peeled purple sugarcane 10-30 parts, peeled ginger 5-7.5 parts, jujube 5-7.5 parts, and prepared licorice root 3-4 parts.

2. The traditional Chinese medicine composition for treating frequent urination with incontinence in various postmenopausal symptoms as described in claim 1, characterized in that: By weight: Astragalus membranaceus 12.5-20 parts, Codonopsis pilosula 12.5-15 parts, Atractylodes macrocephala 7.5-10 parts, Ziziphus jujuba var. spinosa 10-12.5 parts, Mantis religiosa ootheca 4-5 parts, Paeonia lactiflora 7.5-10 parts, Rehmannia glutinosa 6-7.5 parts, Angelica sinensis 7.5-10 parts, Cinnamomum cassia 2-2.5 parts, Poria cocos 6-7.5 parts, Lindera strychnifolia 5-6 parts, Schisandra chinensis 5-6 parts, Psoralea corylifolia 4-6 parts, Alpinia oxyphylla 4-6 parts, Citrus reticulata 4-6 parts, Polygala tenuifolia 3-4 parts, peeled purple sugarcane 20-30 parts, peeled ginger 5-7.5 parts, jujube 5-7.5 parts, prepared licorice root 3-4 parts; Or by weight: Astragalus membranaceus 10-12.5 parts, Codonopsis pilosula 10-12.5 parts, Atractylodes macrocephala 7.5-10 parts, Ziziphus jujuba var. spinosa 12.5-15 parts, Mantis religiosa ootheca 4-5 parts, Paeonia lactiflora 10-15 parts, Rehmannia glutinosa 7.5-10 parts, Angelica sinensis 7.5-10 parts, Cinnamomum cassia 1.5-2 parts, Poria cocos 6-7.5 parts, Lindera strychnifolia 5-6 parts, Schisandra chinensis 5-6 parts, Psoralea corylifolia 4-6 parts, Alpinia oxyphylla 4-6 parts, Citrus reticulata 4-6 parts, Polygala tenuifolia 3-4 parts, peeled purple sugarcane 10-20 parts, peeled ginger 5-7.5 parts, jujube 5-7.5 parts, and prepared licorice root 3-4 parts.

3. The traditional Chinese medicine composition for treating frequent urination with incontinence in various postmenopausal symptoms as described in claim 2, characterized in that: By weight: Astragalus membranaceus 20 parts, Codonopsis pilosula 15 parts, Atractylodes macrocephala 10 parts, Ziziphus jujuba var. spinosa 10 parts, Mantis religiosa ootheca 5 parts, Paeonia lactiflora 10 parts, Rehmannia glutinosa 7.5 parts, Angelica sinensis 7.5 parts, Cinnamomum cassia 2 parts, Poria cocos 7.5 parts, Lindera strychnifolia 6 parts, Schisandra chinensis 5 parts, Psoralea corylifolia 6 parts, Alpinia oxyphylla 6 parts, Citrus reticulata 6 parts, Polygala tenuifolia 4 parts, peeled purple sugarcane 25 parts, peeled ginger 5 parts, jujube 5 parts, and prepared licorice root 3 parts.

4. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: Mix the other Chinese medicinal materials except cinnamon, soak them in water, decoct them, add cinnamon halfway through, continue heating, filter out the liquid, and obtain the Chinese medicinal composition.

5. The method for preparing the traditional Chinese medicine composition as described in claim 4, characterized in that: The amount of water added is 6-8 times the total weight of the Chinese herbal raw materials.

6. The method for preparing the traditional Chinese medicine composition as described in claim 5, characterized in that: The specific steps of the decoction process are as follows: soak in cold water for 30 minutes, bring to a boil over high heat, simmer over low heat for 50 minutes, then add cinnamon and cook for another 10-15 minutes.

7. The method for preparing the traditional Chinese medicine composition according to claim 6, characterized in that: The decoction is prepared 2-3 times, with 200 ml of liquid extracted each time. The decoctions are then mixed together.

8. The use of a traditional Chinese medicine composition as described in any one of claims 1-3 in the preparation of a medicament for treating frequent urination and incontinence in "menopausal symptoms".

9. A traditional Chinese medicine preparation, characterized in that, It includes the traditional Chinese medicine composition according to any one of claims 1-3 and pharmaceutically acceptable excipients.

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