Traditional Chinese medicine formula for treating climacteric syndrome and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparation, in particular to a traditional Chinese medicine formula for treating climacteric syndrome and a preparation method thereof.The traditional Chinese medicine formula is formed by compatibility of tuber fleeceflower stem, polygala tenuifolia, rhizoma acori graminei and other raw materials according to a specific proportion, the preferable proportion is clear, the formula contains specific active ingredient groups, and the content of the active ingredient groups reaches the standard through HPLC determination. The composition is accurate in compatibility, can comprehensively condition and improve various climacteric symptoms such as hectic fever, night sweat, insomnia and the like, and is definite in active ingredients, reliable in curative effect, high in universality and high in safety. The preparation method comprises specific decoction steps, such as first decoction of the raw dens draconis, staged decoction and adoption of a gradient heating process, the drug effect is improved, meanwhile, the quality is guaranteed through strict quality control, the process is flexible, various dosage forms can be prepared, the traditional Chinese medicine formula is combined with the preparation method, and the traditional Chinese medicine composition has an efficient and safe treatment effect on the climacteric syndrome and is worthy of popularization and application. The clinical application value is obvious.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparation, and more specifically, to a traditional Chinese medicine formula for treating menopausal syndrome and its preparation method. Background Art

[0002] Menopausal syndrome is a syndrome of a series of autonomic nervous function disorders and neuropsychological symptoms caused by the fluctuation or reduction of sex hormones before and after menopause in women. The clinical manifestations include hot flashes and sweating, insomnia and anxiety, menstrual disorders, osteoporosis, etc., which seriously affect the quality of life. At present, Western medicine mainly adopts estrogen replacement therapy (such as nilestriol, livial, etc.), but there are problems such as limited symptom improvement rate and increased risk of adverse reactions with long-term use; traditional Chinese medicine relies on the advantage of overall conditioning and regulates the pathogenesis of yin-yang imbalance and liver-kidney deficiency through compound preparations, which has become an important development direction. However, there are still problems in the existing traditional Chinese medicine treatment plans, such as insufficient pertinence of formula compatibility, extensive preparation process, and poor efficacy stability, and there is an urgent need for optimization and improvement.

[0003] Limitations of Western Medicine Treatment The existing Western medicine treatment mainly focuses on supplementing estrogen. Although it can relieve some symptoms, the clinical symptom improvement rate is generally not high, and long-term use may increase the risks of breast cancer, cardiovascular diseases, etc., and the applicable population is limited. In addition, for non-hormone-dependent symptoms such as hot flashes and sweating, and mood disorders, Western medicine lacks specific intervention means, and the overall efficacy has limitations.

[0004] Space for Compatibility Optimization of Traditional Chinese Medicine Formulas Most of the existing traditional Chinese medicine formulas are based on empirical compatibility, and the pertinence to the core pathogenesis of menopause (such as deficiency of liver and kidney essence and blood, and yin-yang imbalance) needs to be improved. For example, the formula of Chinese Patent CN105168536A is mainly composed of processed fleece-flower root, millettia reticulata, and polygonum multiflorum thunb. vine, focusing on nourishing blood and calming the nerves, but it lacks coverage of the core targets (such as regulation of autonomic nerve function and neuroendocrine intervention) for symptoms such as hot flashes and sweating, anxiety and depression; although Chinese Patent CN103536792A contains ingredients for astringing sweating and calming the nerves such as floating wheat and calcined dragon bone, the formula contains 24 ingredients, which may have problems such as redundant medicinal flavors and ambiguous monarch-minister-assistant-guide relationships, affecting the accuracy of drug efficacy.

[0005] Technical Defects in the Preparation Process Existing preparation methods mostly adopt the traditional water decoction method and do not optimize the extraction process according to the characteristics of different components. For example, Chinese Patent CN105168536A only combines the filtrates of two water decoctions and does not perform prior decoction on mineral drugs (such as uncalcined fossil fragments and calcined oyster shells), which may lead to insufficient dissolution of the ingredients for calming the mind and suppressing hyperactivity; although Chinese Patent CN103536792A performs vinegar processing on Scutellaria baicalensis, subsequent drying by baking and short-time decoction (only 5 minutes) may cause degradation of heat-sensitive components (such as albizia flower flavonoids and ophiopogon saponins) or loss of volatile components (such as Scutellaria baicalensis volatile oil), affecting the medicinal efficacy. In addition, existing processes generally lack modern technical means such as gradient heating, fine filtration, and vacuum drying, making it difficult to ensure the stable content of active ingredients and the safety of the preparation. Summary of the Invention

[0006] The purpose of the present invention is to provide a traditional Chinese medicine formula for treating menopausal syndrome and its preparation method to solve the problems raised in the above background technology.

[0007] To achieve the above purpose, the present invention provides a traditional Chinese medicine formula for treating menopausal syndrome, which is composed of the following raw materials in specific proportions by weight: 25 - 35 parts of polygonum multiflorum thunb, 6 - 12 parts of polygala tenuifolia willd, 3 - 9 parts of acorus tatarinowii schott, 12 - 18 parts of stir-fried amomum villosum lour, 12 - 18 parts of poria cocos wolf, 8 - 12 parts of albizia julibrissin durazz, 10 - 15 parts of raw dragon's teeth, 3 - 9 parts of bupleurum chinense dc, 6 - 12 parts of dried tangerine peel, 8 - 12 parts of raw rehmannia root, and 1 - 5 parts of amber powder.

[0008] Preferably, it includes the following raw materials by weight: 30 parts of polygonum multiflorum thunb, 9 parts of polygala tenuifolia willd, 6 parts of acorus tatarinowii schott, 15 parts of stir-fried amomum villosum lour, 15 parts of poria cocos wolf, 10 parts of albizia julibrissin durazz, 12 parts of raw dragon's teeth, 6 parts of bupleurum chinense dc, 9 parts of dried tangerine peel, 10 parts of raw rehmannia root, and 3 parts of amber powder.

[0009] Preferably, it further includes a specific group of active ingredients: β-sitosterol ≥ 0.3%, saikosaponin a ≥ 0.2%, polygalaxanthone III ≥ 0.15%, total flavonoids ≥ 5%, and the content of active ingredients is determined by HPLC method.

[0010] On the other hand, the present invention also provides a method for preparing the above traditional Chinese medicine composition, which includes the following steps: S1: First decoct raw dragon's teeth for 30 minutes, add polygonum multiflorum thunb, acorus tatarinowii schott, albizia julibrissin durazz, and raw rehmannia root, bring to a boil over high heat and then decoct over low heat for 40 minutes; S2: Add polygala tenuifolia willd, stir-fried amomum villosum lour, poria cocos wolf, bupleurum chinense dc, and dried tangerine peel, and continue to decoct for 20 minutes; S3: Filter the medicinal liquid, add 8 times the amount of water to the medicinal residues and decoct again for 30 minutes; S4: Combine the two decocted liquids, control the temperature to 60°C for concentration, concentrate to a relative density of 1.25 - 1.30, add amber powder and mix evenly to make a pharmaceutical preparation.

[0011] Preferably, soluble starch is added to the concentrated solution, and the mass ratio of the two is 1:0.3. Granules are prepared after drying under reduced pressure at 60 °C.

[0012] Preferably, a gradient temperature decocting process is adopted: (a) After decocting raw dragon teeth at 100 °C for 30 minutes, the remaining medicinal materials are added; (b) The decocting temperature in the first stage is maintained at 95 - 100 °C for 20 minutes; (c) In the second stage, the temperature is reduced to 80 - 85 °C and decocted for 15 minutes to form a multi-component gradient release system.

[0013] Preferably, the pharmaceutical preparation is made into any one of the following dosage forms: granules, tablets, capsules or oral liquids, and each bag of the granules contains 5 - 7 g of crude drug content.

[0014] Preferably, when the dosage form is oral liquid, after the concentrated solution in step S4 is sterilized by moist heat at 105 °C for 30 minutes, 0.1 - 0.3% of sodium benzoate is added as a preservative.

[0015] Preferably, in step S3, filtration is carried out with a microporous membrane with a pore size of 0.22 μm for fine filtration to ensure that the number of insoluble particles in the medicinal liquid is ≤ 2000 per 100 ml.

[0016] Preferably, in step S4, the concentrated solution and soluble starch are granulated in a ratio of 1:0.2 - 0.4 and dried under reduced pressure at 50 - 70 °C.

[0017] Compared with the prior art, the beneficial effects of the present invention are as follows: I. Beneficial effects of the traditional Chinese medicine formula 1. Precise compatibility and comprehensive conditioning In the formula, raw dragon teeth and succinum powder have the functions of calming the mind and suppressing hyperactivity, targeting the common insomnia and palpitations in menopause; polygonum multiflorum thunb stem and cortex albiziae nourish the blood and calm the mind, relieving restlessness and uneasiness; polygala tenuifolia and acorus tatarinowii calm the heart and open the orifices, improving mental restlessness; bupleurum chinense soothes the liver and relieves depression, citrus reticulata blanco regulates qi and harmonizes the middle-jiao, relieving anxiety and depression; poria cocos invigorates the spleen and promotes diuresis, rehmannia glutinosa nourishes yin and clears heat, balancing yin and yang. All the medicinal materials are used together to achieve the effects of tonifying the liver and kidney, calming the heart and soothing the nerves, regulating qi and regulating the middle-jiao, and comprehensively improving menopausal symptoms such as hot flashes and sweating, insomnia, anxiety and depression, and shoulder and back pain.

[0018] 2. Clear active ingredients and reliable curative effects Determined by HPLC method, the contents of active ingredients such as β-sitosterol, saikosaponin a, polygala tenuifolia ketone III, and total flavonoids in the formula meet the standards (β-sitosterol ≥ 0.3%, saikosaponin a ≥ 0.2%, polygala tenuifolia ketone III ≥ 0.15%, total flavonoids ≥ 5%). These ingredients act synergistically to regulate neuroendocrine function, enhance the body's anti-stress ability, improve the therapeutic effect on menopausal syndrome, and are significantly superior to ordinary formulas as verified by experiments (such as the effective rate of hot flashes and night sweats reaching over 93.3%).

[0019] 3. Strong universality and high safety Mainly composed of traditional Chinese medicine raw materials, it avoids the adverse reactions of hormone replacement therapy (such as increasing the risk of cancer), has good curative effects on menopausal syndrome of different syndromes, has a wide range of applicable populations, and has high safety for long-term use.

[0020] II. Beneficial effects of the preparation method 1. Scientific decoction to enhance drug efficacy Decoct raw dragon's teeth first: Ensure that components such as calcium and magnesium in the mineral medicine are fully dissolved to exert the effect of calming the mind and suppressing hyperactivity.

[0021] Decoct in stages: Decoct polygonum multiflorum thunb and acorus tatarinowii first, and then add polygala tenuifolia and stir-fried amomum villosum to avoid excessive loss of volatile components (such as amomum villosum volatile oil), and at the same time ensure the full extraction of components with different properties (such as heat-sensitive flavonoids and saponins).

[0022] Gradient heating process: High-temperature decoction in the first stage to extract heat-stable components (such as saikosaponin), and cooling decoction in the second stage to protect heat-sensitive components (such as albizia julibrissin flavonoids), forming a multi-component gradient release system to improve drug utilization rate.

[0023] 2. Strict quality control to ensure quality Fine filtration process: Use a microporous filter membrane with a pore size of 0.22μm for fine filtration to ensure that the insoluble particles in the medicinal liquid meet the standards (≤2000 particles per 100ml), and improve the safety of the preparation.

[0024] Concentration and drying: Concentrate at a temperature of 50 - 70°C to avoid high-temperature degradation of active ingredients; vacuum drying further ensures the stability of components, and prepare dosage forms such as granules and capsules for easy taking and storage.

[0025] 3. Flexible process and wide applicability It can be made into various dosage forms such as granules, tablets, capsules, and oral liquids to meet the needs of different patients. For example, the oral liquid is sterilized by moist heat and preservatives are added to extend the shelf life; each bag of granules contains a definite amount of crude drug (5 - 7g), with accurate dosage and convenient taking.

[0026] In summary, the compatibility of this traditional Chinese medicine formula is scientific, and the preparation method improves the dissolution and stability of active ingredients through process optimization. The combination of the two achieves the efficient and safe treatment of menopausal syndrome, with significant clinical application value. Detailed implementation manners

[0027] Next, in combination with the embodiments of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0028] Embodiment 1 (preferred example) Raw material composition (parts by weight): 30 parts of Polygonum multiflorum Thunb. var. thomsonii (Wall.) Stew., 9 parts of Polygala tenuifolia Willd., 6 parts of Acorus tatarinowii Schott, 15 parts of stir-fried Amomum villosum Lour., 15 parts of Poria cocos (Schw.) Wolf, 10 parts of Albizia julibrissin Durazz., 12 parts of Odontosoria yunnanensis (Baker) Ching, 6 parts of Bupleurum chinense DC., 9 parts of Citrus reticulata Blanco, 10 parts of Rehmannia glutinosa Libosch. and 3 parts of succinum powder.

[0029] Preparation method: First decoct Odontosoria yunnanensis (Baker) Ching: Take Odontosoria yunnanensis (Baker) Ching and add 10 times the amount of water (calculated based on the total weight of the raw materials). After boiling with strong fire, decoct with slow fire for 30 minutes to release mineral components such as calcium salts.

[0030] First-stage decoction: Add Polygonum multiflorum Thunb. var. thomsonii (Wall.) Stew., Acorus tatarinowii Schott, Albizia julibrissin Durazz. and Rehmannia glutinosa Libosch. After boiling with strong fire, maintain with slow fire for 40 minutes to promote the dissolution of anthraquinone components in Polygonum multiflorum Thunb. var. thomsonii (Wall.) Stew. and volatile oil in Acorus tatarinowii Schott.

[0031] Second-stage decoction: Add Polygala tenuifolia Willd., stir-fried Amomum villosum Lour., Poria cocos (Schw.) Wolf, Bupleurum chinense DC. and Citrus reticulata Blanco, and continue to decoct for 20 minutes to avoid excessive loss of volatile oil in Amomum villosum Lour.

[0032] Filtration and re-decoction: The medicinal liquid is coarsely filtered through a 200-mesh filter cloth, and the medicinal residues are re-decocted with 8 times the amount of water for 30 minutes, and the two decocted liquids are combined.

[0033] Concentration and granulation: Concentrate under reduced pressure at 50-70 °C to a relative density of 1.25-1.30 (measured at 60 °C), add succinum powder and mix evenly. Granulate according to the ratio of concentrated liquid: soluble starch = 1:0.3 (mass ratio), and dry under reduced pressure at 60 °C until the moisture content ≤ 5%, and pack into 5-g granule agents per bag.

[0034] Quality control: Active ingredients: β-sitosterol ≥ 0.3%, saikosaponin a ≥ 0.2%, tenuifolin III ≥ 0.15%, total flavonoids ≥ 5% (determined by HPLC method, chromatographic column CAPCELLPAK C18, mobile phase acetonitrile-0.1% phosphoric acid gradient elution).

[0035] Microbial limit: comply with the requirements under the item of Granules in Chinese Pharmacopoeia.

[0036] Example 2 (lower limit of raw material range) Raw material composition (parts by weight): Polygonum multiflorum Thunb. 25 parts, Polygala tenuifolia Willd. 6 parts, Acorus tatarinowii Schott 3 parts, stir-fried Amomum villosum Lour. 12 parts, Poria cocos (Schw.) Wolf 12 parts, Albizia julibrissin Durazz. 8 parts, Odontotermes formosanus (Shiraki) 10 parts, Bupleurum chinense DC. 3 parts, Citrus reticulata Blanco 6 parts, Rehmannia glutinosa Libosch. 8 parts, Succinum powder 1 part.

[0037] Preparation method: Decoct Odontotermes formosanus (Shiraki) first: add 8 times the amount of water, bring to a boil over high heat and then simmer for 30 minutes over low heat.

[0038] Combine decoctions: add the remaining medicinal materials, bring to a boil over high heat and then simmer for 40 minutes over low heat, filter, and decoct the dregs with 6 times the amount of water for another 20 minutes.

[0039] Concentrate and granulate: combine the decoction liquids, concentrate to a relative density of 1.28 at 60 °C, add soluble starch (ratio 1:0.3), dry under reduced pressure at 60 °C and then granulate, with each bag containing 7 g of crude drug content.

[0040] Features: Component analysis: due to the reduction in the amount of raw materials used, the content of β-sitosterol is about 0.28% (close to the lower limit of the standard), and the content of saikosaponin a is about 0.18%. Process optimization is required to ensure the efficacy.

[0041] Applicable scenarios: suitable for menopausal patients with mild symptoms, or used as a basic formula with additions or subtractions.

[0042] Example 3 (upper limit of raw material range + gradient process) Raw material composition (parts by weight): Polygonum multiflorum Thunb. 35 parts, Polygala tenuifolia Willd. 12 parts, Acorus tatarinowii Schott 9 parts, stir-fried Amomum villosum Lour. 18 parts, Poria cocos (Schw.) Wolf 18 parts, Albizia julibrissin Durazz. 12 parts, Odontotermes formosanus (Shiraki) 15 parts, Bupleurum chinense DC. 9 parts, Citrus reticulata Blanco 12 parts, Rehmannia glutinosa Libosch. 12 parts, Succinum powder 5 parts.

[0043] Preparation method: Decoct with gradient temperature increase: Stage 1: Decoct Odontotermes formosanus (Shiraki) at 100 °C for 30 minutes to release calcium and magnesium ions.

[0044] Stage 2: Add the remaining medicinal materials and decoct at 95 - 100 °C for 20 minutes to extract heat-stable components such as saikosaponin and polygalaxanthone.

[0045] Stage 3: Cool down to 80 - 85 °C and decoct for 15 minutes to protect volatile oils in Amomum villosum Lour. and heat-sensitive components such as flavonoids in Albizia julibrissin Durazz.

[0046] Fine filtration and sterilization: The decoction is finely filtered through a 0.22 μm microporous membrane to ensure that the number of insoluble particles ≤ 2000 particles / 100 ml, sterilized by moist heat at 105 °C for 30 minutes, and 0.2% sodium benzoate is added for preservation to prepare the oral liquid.

[0047] Advantages: Component retention: The gradient process increases the content of saikosaponin a to 0.25%, polygalaxanthone III to 0.18%, and total flavonoids to 5.5%.

[0048] Clinical application: Suitable for patients with hot flashes, sweating, and severe insomnia. The oral liquid dosage form is absorbed faster.

[0049] Example 4 (specific active ingredient group + fine filtration process) Raw material composition (parts by weight): Same as Example 1 (preferred ratio).

[0050] Preparation method: Gradient temperature decoction: Same as Example 3.

[0051] Fine filtration and drying: After the decoction is finely filtered through a 0.22 μm filter membrane, it is concentrated to a relative density of 1.30 at 50 - 70 °C, soluble starch is added (ratio 1:0.2), dried under reduced pressure at 60 °C, pulverized, and filled into capsules (each capsule contains 0.5 g of crude drug).

[0052] Quality standard: Active ingredients: β-sitosterol 0.32%, saikosaponin a 0.21%, polygalaxanthone III 0.16%, total flavonoids 5.2% (verified by HPLC method).

[0053] Safety: Heavy metals and agricultural residues comply with the standards of the Chinese Pharmacopoeia, and the microbial limit is qualified.

[0054] Two groups of comparative examples Comparative example 1 (lacking key ingredient: succinum powder) Raw material composition (parts by weight): Polygonum multiflorum Thunb. 30 parts, Polygala tenuifolia Willd. 9 parts, Acorus tatarinowii Schott 6 parts, stir-fried Amomum villosum Lour. 15 parts, Poria cocos (Schw.) Wolf 15 parts, Albizia julibrissin Durazz. 10 parts, Draco dentes 12 parts, Bupleurum chinense DC. 6 parts, Citrus reticulata Blanco 9 parts, Rehmannia glutinosa Libosch. 10 parts (without succinum powder).

[0055] Preparation method: Same as Example 1 (conventional decoction process), and granules are prepared.

[0056] Comparative analysis: Component difference: Lack of sedative components such as succinic acid, and the total flavonoid content drops to 4.5%.

[0057] Efficacy prediction: The improvement of insomnia and palpitations symptoms is weak, especially the effect on patients with blood stasis is not obvious.

[0058] Comparative Example 2 (Changing the core process: raw dragon teeth not decocted first + high temperature throughout the process) Raw material composition (parts by weight): Same as Example 1 (preferred ratio).

[0059] Preparation method: Decoct raw dragon teeth together with other medicinal materials: Put all the medicinal materials into cold water, bring to a boil over high heat, and then simmer for 40 minutes.

[0060] Concentrate at high temperature throughout the process: Decoct the liquid directly to a relative density of 1.30 without using gradient temperature increase.

[0061] Comparative analysis: Component dissolution: The dissolution rate of calcium salts in raw dragon teeth decreased by 30%, and saikosaponin a degraded by 15% (destroyed by high temperature).

[0062] Process defect: The loss rate of volatile oil in fructus amomi reached 40%, resulting in weakened qi-regulating efficacy.

[0063] Compare the performance of the traditional Chinese medicine prescriptions for treating menopausal syndrome in the above four groups of examples and two groups of comparative examples as shown in the following table:

[0064] Analyze according to the data in the above table: 1. Hot flashes and night sweats Examples: The effective rate was above 82% (95%, 90%, 96%, 94% for Examples 1 - 4 respectively). This is due to the clearing heat and nourishing yin effects of polygonum multiflorum thunb. and rehmannia glutinosa in the prescription, and the calming and subduing yang effects of raw dragon teeth and succinum powder. The scientific process (such as decocting first and gradient decocting) promotes the dissolution of active ingredients, regulates autonomic nerve disorders, and improves hot flashes and night sweats.

[0065] Comparative examples: The effective rates were only 65% (Comparative Example 1) and 68% (Comparative Example 2). In Comparative Example 1, succinum powder (a key ingredient for calming the mind and suppressing hyperactivity of yang) was missing. In Comparative Example 2, due to the raw dragon teeth not being decocted first and high temperature throughout the process, the dissolution of mineral medicine components and heat-sensitive components was insufficient, and the effect of clearing heat and calming the mind could not be fully exerted.

[0066] 2. Insomnia Examples: The effective rate reached above 85% (92%, 85%, 93%, 91%). The calming ingredients such as polygonum multiflorum thunb., polygala tenuifolia, and cortex albiziae in the prescription were fully released through processes such as decocting first and gradient decocting, and worked together to soothe the nerves and calm the mind.

[0067] Control examples: The effective rates are 60% (Control example 1) and 63% (Control example 2). In Control example 1, amber powder is lacking, resulting in insufficient power for calming the mind by suppressing hyperactive yang; in Control example 2, raw dragon's teeth are not decocted first, with less dissolution of mineral components such as calcium salts, making it difficult to effectively improve insomnia.

[0068] 3. Anxiety and depression Examples: The effective rate is over 83% (90%, 83%, 91%, 89%). Bupleurum can soothe the liver and relieve depression, Albizia julibrissin and Polygala tenuifolia can regulate emotions, Poria can strengthen the spleen and calm the heart, and the process ensures that the contents of active ingredients such as saikosaponin a and tenuifolin reach the standard, thus significantly improving anxiety and depression.

[0069] Control examples: The effective rates are only 55% (Control example 1) and 58% (Control example 2). Due to the lack of formula or technological defects in the control examples, the active ingredients are insufficient and cannot fully regulate emotions.

[0070] 4. Shoulder and back pain Examples: The effective rate is over 82% (88%, 82%, 89%, 87%). Rehmannia glutinosa and Polygonum multiflorum can nourish blood and dredge collaterals, Acorus tatarinowii and Citrus reticulata can dispel dampness and promote qi movement, and the reasonable process promotes the dissolution of active ingredients such as total flavonoids, showing a significant effect on shoulder and back pain.

[0071] Control examples: The effective rates are 50% (Control example 1) and 53% (Control example 2). Due to the lack of ingredients or insufficient dissolution in the control examples, it is difficult to achieve the same effect.

[0072] Summary Due to the reasonable formula compatibility (such as the integrity of key ingredients like amber powder and raw dragon's teeth) and scientific process (such as decocting first, gradient decocting, fine filtration, etc.) in the examples, the effective rate of each symptom is significantly higher than that of the control examples. In the control examples, the low curative effect is caused by either the lack of key ingredients (such as no amber powder in Control example 1) or improper process (such as raw dragon's teeth not being decocted first and the components being destroyed by high temperature throughout the process). This fully verifies the scientific nature, practicality of the formula and process of the present invention and its improvement advantages for menopausal syndrome.

[0073] Advantages of the traditional Chinese medicine formula for treating menopausal syndrome and its preparation method of the present invention: I. Beneficial effects of the traditional Chinese medicine formula 1. Precise compatibility and comprehensive conditioning In the formula, raw dragon's teeth and amber powder can calm the mind by suppressing hyperactive yang, targeting common insomnia and palpitations in menopause; Polygonum multiflorum and Albizia julibrissin can nourish blood and calm the mind, relieving restlessness; Polygala tenuifolia and Acorus tatarinowii can calm the heart and open the orifices, improving mental restlessness; Bupleurum can soothe the liver and relieve depression, and Citrus reticulata can regulate qi and harmonize the middle-jiao, relieving anxiety and depression; Poria can strengthen the spleen and promote diuresis, and Rehmannia glutinosa can nourish yin and clear heat, balancing yin and yang. All the herbs are used together to achieve the effects of tonifying the liver and kidney, calming the mind, regulating qi and regulating the middle-jiao, comprehensively improving menopausal symptoms such as hot flashes and sweating, insomnia, anxiety and depression, and shoulder and back pain.

[0074] 2. Clear active ingredients and reliable efficacy Determined by HPLC method, the contents of active ingredients such as β-sitosterol, saikosaponin a, polygala tenuifolia ketone III, and total flavonoids in the formula meet the standards (β-sitosterol ≥ 0.3%, saikosaponin a ≥ 0.2%, polygala tenuifolia ketone III ≥ 0.15%, total flavonoids ≥ 5%). These ingredients act synergistically to regulate neuroendocrine function, enhance the body's anti-stress ability, improve the therapeutic effect on menopausal syndrome, and through experimental verification (such as the effective rate of hot flashes and night sweats reaching over 93.3%), the efficacy is significantly better than that of ordinary formulas.

[0075] 3. Strong universality and high safety Mainly composed of traditional Chinese medicine raw materials, it avoids the adverse reactions of hormone replacement therapy (such as increasing the risk of cancer), has good curative effects on different syndromes of menopausal syndrome, has a wide range of applicable populations, and has high safety for long-term use.

[0076] II. Beneficial effects of the preparation method 1. Scientific decoction to enhance drug efficacy Decoct raw dragon's teeth first: Ensure that components such as calcium and magnesium in the mineral medicine are fully dissolved to exert the effect of calming the mind and suppressing hyperactivity.

[0077] Decoct in stages: First decoct polygonum multiflorum thunb var. caulis and acorus tatarinowii, etc., then add polygala tenuifolia and stir-fried amomum villosum, etc., to avoid excessive loss of volatile components (such as amomum villosum volatile oil), and at the same time ensure the full extraction of components with different properties (such as heat-sensitive flavonoids and saponins).

[0078] Gradient temperature rise process: In the first stage, decoct at high temperature to extract heat-stable components (such as saikosaponin), and in the second stage, cool down to decoct to protect heat-sensitive components (such as albizia julibrissin bark flavonoids), forming a multi-component gradient release system to improve the drug utilization rate.

[0079] 2. Strict quality control to ensure quality Fine filtration process: Use a microporous filter membrane with a pore size of 0.22μm for fine filtration to ensure that the insoluble particles in the medicinal liquid meet the standards (≤2000 particles per 100ml), and improve the safety of the preparation.

[0080] Concentration and drying: Control the temperature at 50 - 70°C for concentration to avoid high-temperature degradation of active ingredients; vacuum drying further ensures the stability of components, and forms dosage forms such as granules and capsules, which are convenient for taking and storing.

[0081] 3. Flexible process and wide applicability It can be made into various dosage forms such as granules, tablets, capsules, oral liquids, etc. to meet the needs of different patients. For example, the oral liquid is sterilized by moist heat and added with preservatives to extend the shelf life; each bag of granules contains a clear amount of crude drug (5 - 7g), with accurate dosage and convenient taking.

[0082] In summary, the compatibility of this traditional Chinese medicine formula is scientific, and the preparation method improves the dissolution and stability of active ingredients through process optimization. The combination of the two achieves the efficient and safe treatment of menopausal syndrome, with significant clinical application value.

[0083] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. The above embodiments and the descriptions in the specification are only preferred examples of the present invention and are not used to limit the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed.

Claims

1. A Chinese medicine formula for treating menopausal syndrome, characterized in that: The invention comprises the following raw materials in parts by weight which are matched in specific proportions: 25-35 parts of Polygonum multiflorum, 6-12 parts of Polygala tenuifolia, 3-9 parts of Acorus calamus, 12-18 parts of stir-fried Amomum villosum, 12-18 parts of Poria cocos, 8-12 parts of Albizzia julibrissin bark, 10-15 parts of raw Dragon's Tooth, 3-9 parts of Bupleurum chinense, 6-12 parts of dried tangerine peel, 8-12 parts of raw Rehmannia root and 1-5 parts of amber powder.

2. The Chinese medicine prescription for treating menopausal syndrome according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 30 parts of Polygala tenuifolia, 9 parts of Polygala tenuifolia, 6 parts of Acorus calamus, 15 parts of stir-fried Amomum villosum, 15 parts of Poria cocos, 10 parts of Albizzia julibrissin bark, 12 parts of raw Dragon's Tooth, 6 parts of Bupleurum chinense, 9 parts of Citrus reticulatae, 10 parts of raw Rehmannia root and 3 parts of amber powder.

3. The Chinese medicine prescription for treating menopausal syndrome according to claim 1, characterized in that: Also includes specific groups of active ingredients: β-Sitosterol ≥ 0.3%, saikosaponin a ≥ 0.2%, polygalazone III ≥ 0.15%, total flavonoids ≥ 5%, the active ingredient content was determined by HPLC.

4. A method for preparing the Chinese medicine composition according to claim 1, characterized in that: The following steps are involved: S1: First, decoct the raw dragon tooth for 30 minutes, add Polygonum multiflorum, Acorus calamus, Albizzia julibrissin, and Rehmannia root, bring to a boil over high heat, then simmer over low heat for 40 minutes; S2: Add Polygala tenuifolia, stir-fried Amomum villosum, Poria cocos, Bupleurum chinense, and dried orange peel, and continue to boil for 20 minutes; S3: Filter the medicinal liquid, add 8 times the amount of water to the medicinal residue and boil it again for 30 minutes; S4: Combine the two decoctions, control the temperature to 50-70°C for concentration, concentrate to a relative density of 1.25-1.30, add amber powder and mix well to prepare a pharmaceutical preparation.

5. The method for preparing the Chinese medicine prescription for treating menopausal syndrome according to claim 4, characterized in that: Soluble starch is added to the concentrated solution in a mass ratio of 1:0.3, and the concentrated solution is dried under reduced pressure at 60° C. and then granulated.

6. The method for preparing the Chinese medicine prescription for treating menopausal syndrome according to claim 4, characterized in that: Adopt gradient temperature rising decoction process: S11: After boiling the raw dragon tooth at 100°C for 30 minutes, add the remaining medicinal materials; S12: In the first stage, the boiling temperature is maintained at 95-100°C for 20 minutes; S13: In the second stage, the temperature is lowered to 80-85°C and boiled for 15 minutes to form a multi-component gradient release system.

7. The method for preparing the Chinese medicine prescription for treating menopausal syndrome according to claim 4, characterized in that: The pharmaceutical preparation is prepared into any of the following dosage forms: granules, tablets, capsules or oral liquids, wherein each bag of granules contains 5-7g of crude drug.

8. The method for preparing the Chinese medicine formula for treating menopausal syndrome according to claim 7, characterized in that: When the dosage form is an oral liquid, after the concentrate in step S4 is sterilized by wet heat at 105° C. for 30 minutes, 0.1-0.3% sodium benzoate is added as a preservative.

9. The method for preparing the Chinese medicine prescription for treating menopausal syndrome according to claim 4, characterized in that: In step S3, a microporous filter membrane with a pore size of 0.22 μm is used for fine filtration to ensure that the insoluble particles in the drug solution are ≤ 2000 particles per 100 ml.

10. The method for preparing the Chinese medicine formula for treating menopausal syndrome according to claim 4, characterized in that: In step S4, the concentrated solution and the soluble starch are granulated in a ratio of 1:0.2-0.4, and dried under reduced pressure at 50-70°C.

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