Traditional Chinese medicine composition for treating climacteric syndrome as well as preparation method and application thereof

Abstract

The invention relates to a traditional Chinese medicine composition material, in particular to a traditional Chinese medicine composition for treating climacteric syndrome as well as a preparation method and application thereof, and the traditional Chinese medicine composition is prepared from the following raw material medicines: radix bupleuri, radix paeoniae alba, liquorice, cortex phellodendri, scutellaria baicalensis, radix ophiopogonis, pericarpium citri reticulatae, ligustrum lucidum, dogwood, valerian, ligusticum wallichii, poria cocos, corn stigma, leonurus, semen cuscutae and rhizoma acori graminei. Wherein the radix paeoniae alba, the radix scutellariae, the pericarpium citri reticulatae, the fructus corni, the valerian and the rhizoma chuanxiong need to be subjected to fermentation pretreatment, and the corn stigma and the herba leonuri need to be subjected to secondary treatment. The traditional Chinese medicine composition for treating the climacteric syndrome, provided by the invention, shows a remarkable treatment effect and product advantages by virtue of a unique raw material formula and an innovative preparation process. In the aspect of raw material selection, sixteen traditional Chinese medicinal materials including radix bupleuri, radix paeoniae alba, liquorice and the like are elaborately matched, all the medicinal materials have a synergistic effect, the effect of regulating the function of a human body can be achieved from multiple aspects, and the effect of treating the climacteric syndrome is greatly improved.

Description

Technical Field

[0001] The present invention relates to traditional Chinese medicine composition materials, and specifically to a traditional Chinese medicine composition for treating menopausal syndrome, its preparation method and application. Background Art

[0002] Menopausal syndrome is a series of physical and mental symptoms caused by fluctuations or decreases in hormone levels in the body during the transitional stage from middle age to old age in women and some men. It mostly occurs in women aged 45 - 55, and the onset age in men is relatively later. This disease not only involves vasomotor symptoms such as hot flashes and night sweats, but also includes neuropsychiatric symptoms such as anxiety and depression, as well as urogenital atrophy symptoms and osteoporosis, etc., seriously affecting the quality of life of patients.

[0003] Currently, the clinical treatment of menopausal syndrome mainly uses chemical drugs, such as hormone replacement therapy. However, these chemical drugs have many drawbacks. Long - term use of hormone drugs may increase the risk of breast cancer, endometrial cancer, cardiovascular diseases, and also cause adverse reactions such as nausea, vomiting, headache, etc. In addition, some chemical drugs can only relieve surface symptoms and cannot regulate the body functions as a whole, easily leading to recurrence of the disease.

[0004] In contrast, traditional Chinese medicine has unique advantages in treating menopausal syndrome. Traditional Chinese medicine pays attention to overall conditioning, improves symptoms from the root by regulating the balance of yin and yang and the circulation of qi and blood in the human body. At the same time, traditional Chinese medicine has relatively few adverse reactions and high safety, being suitable for long - term use. However, traditional Chinese medicine preparations have deficiencies in the extraction and utilization of active ingredients. The present invention aims to overcome these defects, through fermentation pretreatment and secondary treatment of specific Chinese medicinal materials, to improve the dissolution and content of active ingredients, optimize the formula and preparation process of the traditional Chinese medicine composition, and provide a safer, more effective and higher - quality treatment option for patients with menopausal syndrome. Summary of the Invention

[0005] Aiming at the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating menopausal syndrome, its preparation method and application.

[0006] To achieve the above object, the present invention provides the following technical solutions:

[0007] A traditional Chinese medicine composition for treating menopausal syndrome, calculated by weight, the traditional Chinese medicine composition is composed of the following raw materials: 3 - 6 parts of Bupleuri Radix, 12 - 15 parts of Paeoniae Radix Alba, 5 - 8 parts of Glycyrrhizae Radix et Rhizoma, 6 - 7 parts of Phellodendri Chinensis Cortex, 8 - 12 parts of Scutellariae Radix, 10 - 15 parts of Ophiopogonis Radix, 8 - 10 parts of Citri Reticulatae Pericarpium, 14 - 20 parts of Ligustri Lucidi Fructus, 14 - 18 parts of Corni Fructus, 2 - 5 parts of Valerianae Radix, 8 - 14 parts of Chuanxiong Rhizoma, 10 - 16 parts of Poria, 18 - 20 parts of Stigmata Maydis, 10 - 15 parts of Leonuri Herba, 6 - 10 parts of Cuscuta Chinensis Semen, 5 - 8 parts of Acori Tatarinowii Rhizoma;

[0008] Among them, Paeonia lactiflora Pall., Scutellaria baicalensis Georgi, Citrus reticulata Blanco, Cornus officinalis Sieb. et Zucc., Valeriana officinalis L., and Ligusticum chuanxiong Hort. need to undergo fermentation pretreatment, and Stigma maydis and Leonurus japonicus Houtt. need to undergo secondary treatment.

[0009] As a further technical solution, the specific steps include material preparation, fermentation pretreatment, secondary treatment, and mixing and formulation.

[0010] As a further technical solution, the fermentation pretreatment step is specifically as follows:

[0011] Select a composite bacterium agent obtained by mixing Bifidobacterium and Lactobacillus acidophilus in a ratio of 1:3;

[0012] Before inoculation, Paeonia lactiflora Pall., Scutellaria baicalensis Georgi, Citrus reticulata Blanco, Cornus officinalis Sieb. et Zucc., Valeriana officinalis L., and Ligusticum chuanxiong Hort. are respectively crushed to 80-100 meshes and sterilized.

[0013] According to the ratio of adding 20-30 g of the composite bacterium agent per kilogram of medicinal materials, the bacterium agent is evenly sprayed on the surface of the sterilized medicinal material powder by means of a spraying device, and sterile water is added to keep the water content of the material at 40%-50%.

[0014] The inoculated material is transferred to a fermentation tank. During the fermentation process, the environmental humidity is controlled at 60%-70%, the temperature is maintained at 30-35 °C, the fermented material is stirred for 1 min every 12 hours, and the fermentation continues for 6-7 days, and then the material is discharged and steam sterilized.

[0015] As a further technical solution, the secondary treatment includes: a primary treatment link and a secondary treatment link;

[0016] Among them, in the primary treatment link, Stigma maydis and Leonurus japonicus Houtt. are mixed, and then 8-10 times the total weight of the mixed medicinal materials of Stigma maydis and Leonurus japonicus Houtt. is added, and conventional decoction is carried out at 90-95 °C for 2-3 hours, and after concentration to 10% of the original volume, a concentrated solution is obtained.

[0017] As a further technical solution, the secondary treatment link in the secondary treatment is:

[0018] The concentrated solution obtained from the primary treatment is transferred to a reaction vessel, ultrasonic waves with a frequency of 30-40 kHz are applied, and the treatment is carried out for 5-7 min;

[0019] Then a rotating magnetic field with an intensity of 55-60 mT is applied, and the treatment is carried out for 30-40 minutes under the condition of a temperature of 30-40 °C;

[0020] After the treatment is completed, membrane separation technology is used, and ultrafiltration membranes with a molecular weight cut-off of 2000-2500 Da are used for filtration and separation;

[0021] Finally, after spray drying, a secondary treatment product is obtained.

[0022] As a further technical solution, the mixing and preparation step is as follows: First, Bupleurum chinense, Glycyrrhiza uralensis, Phellodendron amurense, Ophiopogon japonicus, Ligustrum lucidum, Poria cocos, Cuscuta chinensis, and Acorus tatarinowii are ultrafinely pulverized to a particle size of 50 - 80 μm, then the product obtained by fermentation pretreatment and the product obtained by secondary treatment are mixed therewith, and then excipients are added to process and obtain the traditional Chinese medicine composition.

[0023] As a further technical solution, the excipients are starch, sodium carboxymethyl starch, and magnesium stearate.

[0024] As a further technical solution, the dosage of starch is 10% - 12% of the total mass of the traditional Chinese medicine composition; the dosage of sodium carboxymethyl starch is 3% - 3.5% of the total mass of the traditional Chinese medicine composition; the dosage of magnesium stearate is 0.5% - 0.8% of the total mass of the traditional Chinese medicine composition.

[0025] As a further technical solution, the traditional Chinese medicine composition is any one of pills, powders, tablets, or capsules.

[0026] The traditional Chinese medicine composition obtained by the preparation method of a traditional Chinese medicine composition for treating menopausal syndrome is applied to treat menopausal syndrome.

[0027] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0028] The traditional Chinese medicine composition for treating menopausal syndrome provided by the present invention, with its unique raw material formula and innovative preparation process, demonstrates remarkable therapeutic effects and product advantages.

[0029] First, in terms of raw material selection, the present invention carefully combines sixteen traditional Chinese medicinal materials such as Bupleurum chinense, Paeonia lactiflora, and Glycyrrhiza uralensis. Each medicinal material acts synergistically and can play the role of regulating the human body's functions from multiple aspects, greatly improving the effect of treating menopausal syndrome. At the same time, the fermentation pretreatment and secondary treatment processes significantly enhance the medicinal efficacy performance of the traditional Chinese medicine composition.

[0030] The present invention aims at the fermentation pretreatment of six Chinese medicinal materials such as white peony root and scutellaria baicalensis, and selects a compound bacterial agent which is a mixture of bifidobacterium and lactobacillus acidophilus in a specific proportion. Under suitable temperature, humidity and time conditions, the microorganisms interact with the medicinal materials. On the one hand, it promotes the decomposition of macromolecular substances in the medicinal materials and increases the dissolution of active ingredients. On the other hand, the metabolites of the microorganisms may also produce new active ingredients, significantly increasing the contents of active ingredients such as paeoniflorin and baicalin, and enhancing the effects of nourishing blood and regulating menstruation, anti-inflammatory and antibacterial of the traditional Chinese medicine composition. The secondary treatment of corn silk and motherwort also has remarkable effects. Through a series of processes such as conventional decoction, ultrasonic treatment, rotating magnetic field treatment, membrane separation and spray drying, not only the active ingredients such as stachydrine hydrochloride are effectively enriched and their contents are increased, but also impurities are removed and the product purity is improved. This enables the traditional Chinese medicine composition to play a better effect in regulating endocrine and effectively alleviates the symptoms of menopausal syndrome.

[0031] Compared with conventional traditional Chinese medicine, after the traditional Chinese medicine composition of the present invention is taken, the absorption rate of the human body is relatively fast, and the uncomfortable symptoms such as hot flashes and night sweats of the patient can be effectively controlled, and the anxiety mood is also significantly reduced.

[0032] Description of the drawings

[0033] Figure 1 is the preparation flow chart of the present invention. Detailed implementation manners

[0034] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0035] The present application provides a traditional Chinese medicine composition for treating menopausal syndrome and a preparation method thereof.

[0036] Among them, the traditional Chinese medicine composition for treating menopausal syndrome of the present application is composed of the following raw materials by weight: 3-6 parts of bupleurum root, 12-15 parts of white peony root, 5-8 parts of licorice root, 6-7 parts of phellodendron bark, 8-12 parts of scutellaria baicalensis, 10-15 parts of dwarf lilyturf tuber, 8-10 parts of dried tangerine peel, 14-20 parts of glossy privet fruit, 14-18 parts of Asiatic cornelian cherry fruit, 2-5 parts of valerian root, 8-14 parts of chuanxiong rhizome, 10-16 parts of poria cocos, 18-20 parts of corn silk, 10-15 parts of motherwort, 6-10 parts of dodder seed, 5-8 parts of grassleaf sweetflag rhizome; and the white peony root, scutellaria baicalensis, dried tangerine peel, Asiatic cornelian cherry fruit, valerian root, chuanxiong rhizome need to be subjected to fermentation pretreatment, and the corn silk and motherwort need to be subjected to secondary treatment.

[0037] The specific steps of the fermentation pretreatment are as follows:

[0038] A compound bacterium agent obtained by mixing Bifidobacterium and Lactobacillus acidophilus in a ratio of 1:3;

[0039] Before inoculation, Paeonia lactiflora, Scutellaria baicalensis, Citrus reticulata Blanco, Cornus officinalis, Valeriana officinalis, and Ligusticum chuanxiong are respectively pulverized to 80 - 100 meshes and sterilized;

[0040] According to the ratio of adding 20 - 30 g of the compound bacterium agent per kilogram of medicinal materials, the bacterium agent is evenly sprayed on the surface of the sterilized medicinal material powder by means of a spraying device, and sterile water is added to keep the moisture content of the material at 40% - 50%;

[0041] The inoculated material is transferred to a fermentation tank. During the fermentation process, the environmental humidity is controlled at 60% - 70%, the temperature is maintained at 30 - 35 °C, the fermented material is stirred for 1 min every 12 hours, and the fermentation continues for 6 - 7 days, and then the material is discharged and steam - sterilized.

[0042] The secondary treatment includes: a primary treatment link and a secondary treatment link;

[0043] Among them, in the primary treatment link, corn silk and motherwort are mixed, and then 8 - 10 times the total weight of the mixed medicinal materials of corn silk and motherwort is added, and conventional decoction is carried out at 90 - 95 °C for 2 - 3 hours, and after concentration to 10% of the original volume, a concentrated solution is obtained.

[0044] The secondary treatment link in the secondary treatment is:

[0045] The concentrated solution obtained from the primary treatment is transferred to a reaction vessel, ultrasonic waves with a frequency of 30 - 40 kHz are applied, and the treatment is carried out for 5 - 7 min;

[0046] Then a rotating magnetic field with an intensity of 55 - 60 mT is applied, and under the condition of a temperature of 30 - 40 °C, the treatment is carried out for 30 - 40 minutes;

[0047] After the treatment, membrane separation technology is used, and ultrafiltration membranes with a molecular weight cut - off of 2000 - 2500 Da are used for filtration and separation;

[0048] Finally, after spray - drying, a secondary treatment product is obtained.

[0049] The mixing and formulation process is as follows: First, Bupleurum chinense, Glycyrrhiza uralensis, Phellodendron amurense, Ophiopogon japonicus, Ligustrum lucidum, Poria cocos, Cuscuta chinensis, and Acorus tatarinowii are ultrafinely pulverized to a particle size of 50 - 80 μm. Then, the product obtained through fermentation pretreatment and the product obtained through secondary treatment are mixed with them. Subsequently, excipients are added to process and obtain the traditional Chinese medicine composition. The excipients are starch, sodium carboxymethyl starch, and magnesium stearate. The dosage of starch is 10% - 12% of the total mass of the traditional Chinese medicine composition; the dosage of sodium carboxymethyl starch is 3% - 3.5% of the total mass of the traditional Chinese medicine composition; the dosage of magnesium stearate is 0.5% - 0.8% of the total mass of the traditional Chinese medicine composition. The traditional Chinese medicine composition is any one of pills, powders, tablets, or capsules.

[0050] The following are specific examples:

[0051] Example 1

[0052] A traditional Chinese medicine composition for treating menopausal syndrome, calculated by weight, consists of the following raw medicinal materials: 3 parts of Bupleurum chinense, 12 parts of Paeonia lactiflora, 5 parts of Glycyrrhiza uralensis, 6 parts of Phellodendron amurense, 8 parts of Scutellaria baicalensis, 10 parts of Ophiopogon japonicus, 8 parts of Citrus reticulata Blanco, 14 parts of Ligustrum lucidum, 14 parts of Cornus officinalis, 2 parts of Valeriana officinalis, 8 parts of Ligusticum chuanxiong, 10 parts of Poria cocos, 18 parts of Stigma maydis, 10 parts of Leonurus japonicus, 6 parts of Cuscuta chinensis, and 5 parts of Acorus tatarinowii.

[0053] Fermentation pretreatment steps:

[0054] A compound bacterial agent obtained by mixing Bifidobacterium and Lactobacillus acidophilus in a ratio of 1:3 is selected;

[0055] Before inoculation, Paeonia lactiflora, Scutellaria baicalensis, Citrus reticulata Blanco, Cornus officinalis, Valeriana officinalis, and Ligusticum chuanxiong are respectively pulverized to 80 meshes and sterilized;

[0056] According to the ratio of adding 20 g of the compound bacterial agent per kilogram of medicinal materials, the bacterial agent is evenly sprayed on the surface of the sterilized medicinal material powder by means of a spraying device, and sterile water is added to maintain the moisture content of the material at 40%;

[0057] The inoculated material is transferred to a fermentation tank. During the fermentation process, the environmental humidity is controlled at 60%, the temperature is maintained at 30 °C, the fermentation material is stirred for 1 min every 12 hours, fermentation continues for 6 days, then the material is discharged and steam sterilized.

[0058] Secondary treatment:

[0059] In the primary treatment step, Stigma maydis and Leonurus japonicus are mixed, and then 8 times the total weight of the mixed medicinal materials of Stigma maydis and Leonurus japonicus is added, and conventional decoction is carried out at 90 °C for 2 hours, and after concentration to 10% of the original volume, a concentrated solution is obtained.

[0060] The secondary treatment process is as follows: Transfer the concentrated liquid obtained from the primary treatment to a reaction vessel, apply ultrasonic waves with a frequency of 30 kHz, and process for 5 minutes; then apply a rotating magnetic field with an intensity of 55 mT and process for 30 minutes under the condition of a temperature of 30 °C; after the treatment, filter and separate through a membrane separation technique using an ultrafiltration membrane with a molecular weight cut-off of 2000 Da; finally, obtain the secondary treatment product through spray drying.

[0061] Mixing and compounding: First, ultra-finely pulverize Bupleurum chinense, Glycyrrhiza uralensis, Phellodendron amurense, Ophiopogon japonicus, Ligustrum lucidum, Poria cocos, Cuscuta chinensis, and Acorus tatarinowii to a particle size of 50 μm, then mix the product obtained from the fermentation pretreatment and the product obtained from the secondary treatment with them, and subsequently add excipients to process and obtain a traditional Chinese medicine composition in the form of pills; the dosage of starch in the excipients is 10% of the total mass of the traditional Chinese medicine composition; the dosage of sodium carboxymethyl starch is 3% of the total mass of the traditional Chinese medicine composition; the dosage of magnesium stearate is 0.5% of the total mass of the traditional Chinese medicine composition.

[0062] Example 2

[0063] A traditional Chinese medicine composition for treating menopausal syndrome, calculated by weight, consists of the following raw medicinal materials: 4 parts of Bupleurum chinense, 13 parts of Paeonia lactiflora, 6 parts of Glycyrrhiza uralensis, 6.5 parts of Phellodendron amurense, 10 parts of Scutellaria baicalensis, 12 parts of Ophiopogon japonicus, 9 parts of Citrus reticulata Blanco, 16 parts of Ligustrum lucidum, 16 parts of Cornus officinalis, 3 parts of Valeriana officinalis, 10 parts of Ligusticum chuanxiong, 12 parts of Poria cocos, 19 parts of Stigma maydis, 12 parts of Leonurus japonicus, 8 parts of Cuscuta chinensis, and 6 parts of Acorus tatarinowii.

[0064] Fermentation pretreatment steps:

[0065] Select a compound bacterial agent obtained by mixing Bifidobacterium and Lactobacillus acidophilus in a ratio of 1:3;

[0066] Before inoculation, pulverize Paeonia lactiflora, Scutellaria baicalensis, Citrus reticulata Blanco, Cornus officinalis, Valeriana officinalis, and Ligusticum chuanxiong to 90 mesh respectively and perform sterilization treatment;

[0067] According to the ratio of adding 25 g of the compound bacterial agent per kilogram of medicinal materials, evenly spray the bacterial agent on the surface of the sterilized medicinal material powder with the aid of a spraying device, and add sterile water to maintain the moisture content of the material at 45%;

[0068] Transfer the inoculated material to a fermentation tank. During the fermentation process, control the environmental humidity at 65%, maintain the temperature at 32 °C, turn over the fermented material for 1 minute every 12 hours, continuously ferment for 6.5 days, then discharge the material and perform steam sterilization.

[0069] Secondary treatment:

[0070] In the primary treatment process, mix Stigma maydis and Leonurus japonicus, then add 9 times the total weight of the mixed medicinal materials of Stigma maydis and Leonurus japonicus, and perform conventional decoction at 92 °C for 2.5 hours, and concentrate to 10% of the original volume to obtain a concentrated liquid.

[0071] The secondary treatment process is as follows: transfer the concentrated liquid obtained from the primary treatment to a reaction vessel, apply ultrasonic waves with a frequency of 35 kHz, and process for 6 minutes; then apply a rotating magnetic field with an intensity of 57 mT and process for 35 minutes under the condition of a temperature of 35 °C; after the treatment is completed, filter and separate through a membrane separation technique using an ultrafiltration membrane with a molecular weight cut-off of 2200 Da; finally, obtain the secondary treatment product through spray drying.

[0072] Mixing and formulation: First, ultra-finely pulverize Bupleurum chinense, Glycyrrhiza uralensis, Phellodendron amurense, Ophiopogon japonicus, Ligustrum lucidum, Poria cocos, Cuscuta chinensis, and Acorus tatarinowii to a particle size of 60 μm, then mix them with the product obtained from the fermentation pretreatment and the secondary treatment product, and subsequently add excipients to process and obtain a traditional Chinese medicine composition in the form of a powder; the dosage of starch in the excipients is 11% of the total mass of the traditional Chinese medicine composition; the dosage of sodium carboxymethyl starch is 3.2% of the total mass of the traditional Chinese medicine composition; the dosage of magnesium stearate is 0.6% of the total mass of the traditional Chinese medicine composition.

[0073] Example 3

[0074] A traditional Chinese medicine composition for treating menopausal syndrome, calculated by weight, consists of the following raw materials: 5 parts of Bupleurum chinense, 14 parts of Paeonia lactiflora, 7 parts of Glycyrrhiza uralensis, 6.8 parts of Phellodendron amurense, 11 parts of Scutellaria baicalensis, 14 parts of Ophiopogon japonicus, 9.5 parts of Citrus reticulata Blanco, 18 parts of Ligustrum lucidum, 17 parts of Cornus officinalis, 4 parts of Valeriana officinalis, 12 parts of Ligusticum chuanxiong, 14 parts of Poria cocos, 19.5 parts of Zea mays stigma, 14 parts of Leonurus japonicus, 9 parts of Cuscuta chinensis, and 7 parts of Acorus tatarinowii.

[0075] Fermentation pretreatment steps:

[0076] Select a compound bacterial agent obtained by mixing Bifidobacterium and Lactobacillus acidophilus in a ratio of 1:3;

[0077] Before inoculation, pulverize Paeonia lactiflora, Scutellaria baicalensis, Citrus reticulata Blanco, Cornus officinalis, Valeriana officinalis, and Ligusticum chuanxiong to 95 meshes respectively and sterilize them;

[0078] Spray the bacterial agent evenly on the surface of the sterilized medicinal material powder with the help of a spraying device according to the ratio of adding 28 g of the compound bacterial agent per kilogram of medicinal material, and add sterile water to maintain the water content of the material at 48%;

[0079] Transfer the inoculated material to a fermentation tank. During the fermentation process, control the environmental humidity at 68%, maintain the temperature at 34 °C, stir the fermented material for 1 minute every 12 hours, continuously ferment for 6.8 days, then discharge the material and sterilize it with steam.

[0080] Secondary treatment:

[0081] In the first treatment step, corn silk and motherwort are mixed, and then 9.5 times the total weight of the mixed medicinal materials of corn silk and motherwort is added, and conventional decoction is carried out at 94 °C for 2.8 hours, and after concentration to 10% of the original volume, a concentrated solution is obtained.

[0082] The second treatment step is as follows: transfer the concentrated solution obtained in the first treatment to a reaction vessel, apply ultrasonic waves with a frequency of 38 kHz, and process for 6.5 min; then apply a rotating magnetic field with a strength of 58 mT, and under the condition of a temperature of 38 °C, process for 38 minutes; after the treatment is completed, then through membrane separation technology, ultrafiltration membrane with a molecular weight cut-off of 2400 Da is used for filtration and separation; finally, through spray drying, a second treatment product is obtained.

[0083] Mixing and formulation: First, bupleurum, licorice, phellodendron, ophiopogon, ligustrum, poria, cuscuta, and acorus tatarinowii are ultra-finely pulverized to a particle size of 70 μm, and then the product obtained by fermentation pretreatment and the product obtained by the second treatment are mixed with them, and then excipients are added to process a traditional Chinese medicine composition in tablet form; the amount of starch in the excipients is 11.5% of the total mass of the traditional Chinese medicine composition; the amount of sodium carboxymethyl starch is 3.4% of the total mass of the traditional Chinese medicine composition; the amount of magnesium stearate is 0.7% of the total mass of the traditional Chinese medicine composition.

[0084] Example 4

[0085] A traditional Chinese medicine composition for treating menopausal syndrome, calculated by weight, consists of the following raw medicinal materials: 6 parts of bupleurum, 15 parts of white peony root, 8 parts of licorice, 7 parts of phellodendron, 12 parts of scutellaria baicalensis, 15 parts of ophiopogon japonicus, 10 parts of tangerine peel, 20 parts of ligustrum lucidum, 18 parts of cornel, 5 parts of valerian, 14 parts of chuanxiong, 16 parts of poria, 20 parts of corn silk, 15 parts of motherwort, 10 parts of cuscuta, and 8 parts of acorus tatarinowii.

[0086] Fermentation pretreatment step:

[0087] A compound bacterium agent obtained by mixing bifidobacterium and lactobacillus acidophilus in a ratio of 1:3 is selected;

[0088] Before inoculation, white peony root, scutellaria baicalensis, tangerine peel, cornel, valerian, and chuanxiong are respectively pulverized to 100 meshes and sterilized;

[0089] According to the ratio of adding 30 g of compound bacterium agent per kilogram of medicinal materials, the bacterium agent is evenly sprayed on the surface of the sterilized medicinal material powder by means of a spraying device, and sterile water is added to keep the moisture content of the material at 50%;

[0090] Transfer the inoculated material to a fermentation tank. During the fermentation process, control the environmental humidity at 70%, maintain the temperature at 35 °C, turn over the fermented material for 1 min every 12 hours, continuously ferment for 7 days, then discharge the material, and sterilize with steam.

[0091] Secondary treatment:

[0092] In the primary treatment step, the corn silk and motherwort are mixed, and then 10 times the total weight of the mixed medicinal materials of corn silk and motherwort is added, and conventional decoction is carried out at 95 °C for 3 hours, and after concentration to 10% of the original volume, a concentrated solution is obtained.

[0093] The secondary treatment step is as follows: transfer the concentrated solution obtained from the primary treatment to a reaction vessel, apply ultrasonic waves with a frequency of 40 kHz, and process for 7 min; then apply a rotating magnetic field with an intensity of 60 mT, and under the condition of a temperature of 40 °C, process for 40 minutes; after the treatment is completed, then through membrane separation technology, ultrafiltration membrane with a cut-off molecular weight of 2500 Da is used for filtration and separation; finally, through spray drying, a secondary treatment product is obtained.

[0094] Mixing and preparation: First, bupleurum, licorice, phellodendron, ophiopogon japonicus, ligustrum lucidum, poria cocos, cuscuta chinensis, and acorus tatarinowii are ultra-finely pulverized to a particle size of 80 μm, and then the product obtained by fermentation pretreatment and the secondary treatment product are mixed with them, and then auxiliary materials are added to process a traditional Chinese medicine composition in the form of capsules; the amount of starch used in the auxiliary materials is 12% of the total mass of the traditional Chinese medicine composition; the amount of sodium carboxymethyl starch used is 3.5% of the total mass of the traditional Chinese medicine composition; the amount of magnesium stearate used is 0.8% of the total mass of the traditional Chinese medicine composition.

[0095] Control Example 1

[0096] Based on Example 1, the difference from Example 1 is that Paeonia lactiflora, Scutellaria baicalensis, Citrus reticulata Blanco, Cornus officinalis, Valeriana officinalis, and Ligusticum chuanxiong are not subjected to fermentation pretreatment.

[0097] Control Example 2

[0098] Based on Example 1, the difference from Example 1 is that the secondary treatment of corn silk and motherwort is not carried out. Experiment:

[0099] Determination test of active ingredient content

[0100] With the help of high performance liquid chromatography (HPLC) technology, the contents of paeoniflorin (the main active ingredient of Paeonia lactiflora), baicalin (the main active ingredient of Scutellaria baicalensis), and stachydrine hydrochloride (the main active ingredient of motherwort) in the traditional Chinese medicine compositions of the examples and control examples are determined. Paeoniflorin can nourish blood and regulate menstruation, baicalin has anti-inflammatory and antibacterial properties, and stachydrine hydrochloride can regulate endocrine, and these ingredients all play a key role in improving menopausal syndrome.

[0101] Standard curve drawing: Weigh appropriate amounts of paeoniflorin, baicalin, and stachydrine hydrochloride reference substances respectively, and make reference substance solutions with a series of concentrations by adding methanol. Taking the peak area as the ordinate and the concentration as the abscissa, draw a standard curve to obtain a regression equation.

[0102] Sample solution preparation: Appropriate amounts of the traditional Chinese medicine compositions of the examples and comparative examples were taken, ground finely, accurately weighed, an appropriate amount of methanol was added, ultrasonic extraction was carried out for a certain time, filtered, and the subsequent filtrate was taken as the test solution.

[0103] Content determination: The test solution was accurately pipetted and injected into a high-performance liquid chromatograph to measure the peak area, and the contents of paeoniflorin, baicalin, and stachydrine hydrochloride in the sample were calculated according to the standard curve;

[0104] Table 1

[0105]

[0106]

[0107] It can be seen from the above data that for the traditional Chinese medicine composition prepared by the fermentation pretreatment and secondary treatment of the present invention, the contents of its main active ingredients are significantly higher than those of the comparative examples without the corresponding treatment, fully indicating that the fermentation treatment and secondary treatment can effectively improve the dissolution of the active ingredients in the traditional Chinese medicine composition, thereby improving the product quality and efficacy.

[0108] The efficacy tests were carried out on the traditional Chinese medicine compositions of the examples and comparative examples. 100 patients with menopausal syndrome were randomly selected and randomly divided into 5 groups, with 20 people in each group. They were respectively administered the traditional Chinese medicine compositions of Examples 1-4 and Comparative Examples 1-2 (3 times a day, 5 g each time, and can be taken after mixing with water), and the administration period was 3 months, and the improvement of the patients' symptoms was observed.

[0109] Table 2

[0110] Group Symptom improvement (number of effective cases / total number of cases) Example 1 18 / 20 Example 2 17 / 20 Example 3 18 / 20 Example 4 19 / 20 Comparative Example 1 12 / 20 Comparative Example 2 14 / 20

[0111] It can be seen from Table 2 that the traditional Chinese medicine composition for treating menopausal syndrome prepared in the present invention has good efficacy, and the effect is better after fermentation pretreatment and secondary treatment.

[0112] The preferred embodiments of the present invention disclosed above are only used to help illustrate the present invention. The preferred embodiments do not describe all the details in detail, nor limit the invention to the specific embodiments described. Obviously, many modifications and changes can be made according to the content of this specification.

Claims

1. A traditional Chinese medicine composition for treating menopausal syndrome, characterized in that, The traditional Chinese medicine composition is composed of the following raw materials by weight parts: 3 - 6 parts of Bupleuri Radix, 12 - 15 parts of Paeoniae Radix Alba, 5 - 8 parts of Glycyrrhizae Radix et Rhizoma, 6 - 7 parts of Phellodendri Chinensis Cortex, 8 - 12 parts of Scutellariae Radix, 10 - 15 parts of Ophiopogonis Radix, 8 - 10 parts of Citri Reticulatae Pericarpium, 14 - 20 parts of Ligustri Lucidi Fructus, 14 - 18 parts of Corni Fructus, 2 - 5 parts of Valerianae Radix, 8 - 14 parts of Chuanxiong Rhizoma, 10 - 16 parts of Poria, 18 - 20 parts of Stigma Maydis, 10 - 15 parts of Leonuri Herba, 6 - 10 parts of Cuscuta Chinensis Lam., 5 - 8 parts of Acori Tatarinowii Rhizoma; Among them, Paeoniae Radix Alba, Scutellariae Radix, Citri Reticulatae Pericarpium, Corni Fructus, Valerianae Radix, Chuanxiong Rhizoma need to be pretreated by fermentation, and Stigma Maydis, Leonuri Herba need to be subjected to secondary treatment.

2. The preparation method of a traditional Chinese medicine composition for treating menopausal syndrome according to claim 1, characterized in that, The specific steps include material preparation, fermentation pretreatment, secondary treatment and mixing and preparation.

3. The preparation method of a traditional Chinese medicine composition for treating menopausal syndrome according to claim 2, characterized in that, The fermentation pretreatment step is specifically as follows: Select a compound bacterium agent obtained by mixing Bifidobacterium and Lactobacillus acidophilus in a ratio of 1:3; Before inoculation, Paeoniae Radix Alba, Scutellariae Radix, Citri Reticulatae Pericarpium, Corni Fructus, Valerianae Radix, Chuanxiong Rhizoma are respectively pulverized to 80 - 100 meshes and sterilized; According to the ratio of adding 20 - 30 g of the compound bacterium agent per kilogram of medicinal materials, the bacterium agent is evenly sprayed on the surface of the sterilized medicinal material powder by means of a spraying device, and sterile water is added to keep the water content of the material at 40% - 50%; The inoculated material is transferred to a fermentation tank. During the fermentation process, the environmental humidity is controlled at 60% - 70%, the temperature is maintained at 30 - 35 °C, the fermentation material is stirred for 1 min every 12 hours, and the fermentation continues for 6 - 7 days, and then the material is discharged and sterilized by steam.

4. The preparation method of a traditional Chinese medicine composition for treating menopausal syndrome according to claim 2, wherein, The secondary treatment includes: a primary treatment link and a secondary treatment link; Among them, in the primary treatment link, Stigma Maydis and Leonuri Herba are mixed, and then 8 - 10 times the total weight of the mixed medicinal materials of Stigma Maydis and Leonuri Herba is added, and conventional decoction is carried out at 90 - 95 °C for 2 - 3 hours, and after concentration to 10% of the original volume, a concentrated solution is obtained.

5. The preparation method of a traditional Chinese medicine composition for treating menopausal syndrome according to claim 4, characterized in that, The secondary treatment link in the secondary treatment is as follows: The concentrated solution obtained from the primary treatment is transferred to a reaction vessel, and ultrasonic waves with a frequency of 30 - 40 kHz are applied for 5 - 7 min; Then a rotating magnetic field with an intensity of 55 - 60 mT is applied, and under the condition of a temperature of 30 - 40 °C, it is treated for 30 - 40 minutes; After the treatment, through membrane separation technology, ultrafiltration membranes with a molecular weight cut-off of 2000 - 2500 Da are used for filtration and separation; Finally, through spray drying, a secondary treatment product is obtained.

6. The preparation method of a traditional Chinese medicine composition for treating menopausal syndrome according to claim 2, characterized in that, The mixing and preparation link is as follows: First, Bupleuri Radix, Glycyrrhizae Radix et Rhizoma, Phellodendri Chinensis Cortex, Ophiopogonis Radix, Ligustri Lucidi Fructus, Poria, Cuscuta Chinensis Lam., Acori Tatarinowii Rhizoma are ultra-finely pulverized to make the particle size reach 50 - 80 μm, then the products obtained by fermentation pretreatment and the products obtained by secondary treatment are mixed with them, and then excipients are added to process and obtain the traditional Chinese medicine composition.

7. The preparation method of a traditional Chinese medicine composition for treating menopausal syndrome according to claim 6, characterized in that, The excipients are starch, sodium carboxymethyl starch and magnesium stearate.

8. The preparation method of a traditional Chinese medicine composition for treating menopausal syndrome according to claim 6, wherein, The dosage of the starch is 10% - 12% of the total mass of the traditional Chinese medicine composition; the dosage of the sodium carboxymethyl starch is 3% - 3.5% of the total mass of the traditional Chinese medicine composition; the dosage of the magnesium stearate is 0.5% - 0.8% of the total mass of the traditional Chinese medicine composition.

9. The preparation method of a traditional Chinese medicine composition for treating menopausal syndrome according to claim 6, characterized in that, The traditional Chinese medicine composition is any one of pills, powders, tablets or capsules.

10. The traditional Chinese medicine composition obtained by the preparation method of the traditional Chinese medicine composition for treating menopausal syndrome according to any one of claims 2-9 is used for treating menopausal syndrome.

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