A traditional Chinese medicine composition containing total saponins of Albizia julibrissin, a preparation method and a preparation

Abstract

This invention, entitled "A Traditional Chinese Medicine Composition Containing Total Saponins from Albizia Bark, its Preparation Method, and its Formulation," belongs to the field of traditional Chinese medicine technology. The technical problem to be solved is to provide a method for preparing a traditional Chinese medicine composition with higher and more stable effective component content, and more effective in treating generalized anxiety disorder. The key points of the technical solution are as follows: The preparation method includes the following steps: S1: Albizia bark, floating wheat, and ethanol solution are mixed and extracted by reflux to obtain filter residue 1 and extract A. Extract A is concentrated to obtain component 1; the volume fraction of the ethanol solution is 55%-85%; S2: Filter residue 1 is mixed with Bupleurum, Curcuma, and Salvia miltiorrhiza, and extracted by reflux with an ethanol solution of 20%-40% by volume to obtain filter residue 2 and extract B. Extract B is concentrated to obtain component 2; S3: White peony root, Schisandra chinensis, licorice, and jujube are decocted in water to obtain filter residue 3 and filtrate C. Filtrate C is concentrated to obtain component 3; S4: Components 1, 2, and 3 are combined to obtain an extract, which is then dried.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition containing total saponins from Albizia bark, its preparation method, and formulation. Background Technology

[0002] For understanding the technical content of this invention:

[0003] Generalized anxiety disorder (GAD) is an anxiety disorder characterized by a vague sense of unease and tension without a clear object or specific content, accompanied by significant autonomic symptoms, muscle tension, and restlessness. Physical changes during anxiety include heightened muscle tension, rapid breathing, elevated blood pressure, sweating, dizziness, chest tightness, palpitations, tremors, urinary urgency, urinary frequency, vomiting, abdominal distension, and diarrhea. Psychological changes include excessive excitement, intense focus on a specific task, restlessness, and altered mood and thought patterns. Behavioral changes include heightened alertness, difficulty concentrating, and loss of interest in daily activities. Patients experience unbearable and inescapable suffering.

[0004] Albizia bark is a traditional Chinese medicine derived from the dried bark of the Albizia julibrissin Durazz., a legume. It is typically harvested and dried in summer and autumn. It is sweet and neutral in nature, and enters the heart, liver, and lung meridians. It has the effects of relieving depression and calming the mind, promoting blood circulation and reducing swelling. Clinically, it is mainly used to treat restlessness, depression and insomnia, lung abscess, sores and swellings, and injuries from falls and blows.

[0005] Albizia bark is commonly found in many classic prescriptions. For example, Albizia bark alone is called "Huanghun Tang" (Evening Decoction), which is specifically used to clear the lungs and eliminate carbuncles, treating lung abscesses. Albizia bark combined with Ampelopsis japonica, known as "Hehuan Yin" (Albizia Drink), can detoxify, eliminate carbuncles, and promote wound healing, making it suitable for lung abscesses that are slow to heal. In "Hehuan Jieyu Tang" (Albizia Decoction for Relieving Depression), it is used together with Bupleurum chinense, Cyperus rotundus, Ziziphus jujuba var. spinosa, and Poria cocos to soothe the liver, relieve depression, strengthen the spleen, and calm the mind, effectively treating various symptoms caused by emotional distress.

[0006] Floating wheat is the dried, light, and shriveled fruit of wheat (Triticum aestivum L.), a plant belonging to the genus Triticum of the Poaceae family. It is cool in nature and sweet in taste, and enters the heart meridian. It has the effects of invigorating qi and clearing heat, nourishing the heart and generating fluids, and stopping spontaneous sweating, night sweats, and bone steaming fever. Clinically, it is often used to treat symptoms such as excessive sweating due to deficiency heat, night sweats, dry mouth and tongue, irritability and insomnia. It has the effects of consolidating the exterior and stopping sweating, invigorating qi, and clearing heat.

[0007] The main components of Albizia julibrissin bark include saponins, lignans, organic acids, flavonoids, and tannins, among which saponins are the main active components responsible for its antidepressant effects. Wheat bran, while similar in origin to wheat, exhibits different effects; its content of linolenic acid and linolenic acid is significantly higher than that of wheat, and these are also key components contributing to its anti-inflammatory and mood-improving effects.

[0008] Relevant patent documents retrieved:

[0009] This document, published in China (CN106108539A) on November 16, 2016, discloses a calming and heart-nourishing health-preserving pillow. It consists of a pillowcase and a pillow core containing traditional Chinese medicinal herbs. The herbs, by weight, include 10-12 parts lavender, 4-6 parts Poria cocos, 6-8 parts Platycladus orientalis seed, 10-12 parts Albizia julibrissin bark, 4-6 parts Gastrodia elata, 2-3 parts Polygala tenuifolia, 5-8 parts Poria cocos, 10-15 parts Alpinia oxyphylla, 5-7 parts Polygonum multiflorum, 2-4 parts Triticum aestivum, 5-6 parts Rheum palmatum, 2-4 parts Hibiscus syriacus bark, 6-8 parts Calceolaria fortunei, 1-3 parts Calceolaria lobata leaves, 4-5 parts Caulis Sedum, and 2-4 parts Hemp chinensis root. While the pillow's raw materials include Albizia julibrissin bark and Triticum aestivum, the extraction process and method are not disclosed. However, it is well known to those skilled in the art that different processing methods for traditional Chinese medicine result in different efficacies.

[0010] This document, published in China (CN106110089A) on November 16, 2016, discloses a traditional Chinese medicine composition for treating anxiety and insomnia, and its preparation method. The composition is prepared from the following main ingredients in parts by weight: raw jujube seed, Poria cocos, Polygala tenuifolia, Citrus medica, Paeonia suffruticosa root bark, Ulmus pumila seed, Albizia julibrissin flower, Ligusticum chuanxiong rhizome, apricot kernel, Polygonum multiflorum stem, Platycladus orientalis seed, lotus seed, stir-fried Juncus effusus, Luffa cylindrica sponge, Citrus reticulata peel, stir-fried jujube seed, raw malt, wheat bran, Melia toosendan fruit, bamboo shavings, Salvia miltiorrhiza, Atractylodes macrocephala, and Cicadae periostracum. The ingredient used for treating anxiety and depression includes wheat bran but excludes Albizia julibrissin bark. Furthermore, the preparation method involves conventional decoction, resulting in a low content of active substances in the obtained composition, and its anti-anxiety efficacy needs further improvement.

[0011] The prior art represented by the aforementioned documents has at least the following unresolved technical problems or defects:

[0012] Saponins from Albizia bark and linolenic acid and linoleic acid from Triticum aestivum are the main active components responsible for the efficacy of these two medicinal herbs. However, saponins, linolenic acid, and linoleic acid all suffer from poor water solubility and are easily decomposed at high temperatures, leading to their loss during the preparation of traditional Chinese medicine products and adversely affecting their efficacy. Furthermore, due to their long-chain fatty acid structure, both saponins and linoleic acid are more alcohol-soluble than water-soluble. Therefore, developing a novel preparation method to significantly improve the extraction rate of active ingredients and thus enhance efficacy is a key research focus for researchers in this field. Summary of the Invention

[0013] The purpose of this invention is to provide:

[0014] A traditional Chinese medicine composition containing total saponins from Albizia bark, its preparation method and formulation, and related technologies, to solve technical problems such as providing a method for preparing a traditional Chinese medicine composition with higher and more stable content of effective ingredients and more effective in treating generalized anxiety disorder, or a combination thereof.

[0015] Terminology Explanation:

[0016] Unless otherwise defined, all technical terms in this document have the same meanings as commonly understood by one of ordinary skill in the art to which the subject matter of the claims pertains. Unless otherwise stated, all patents, patent inventions, and publications cited in this document are incorporated herein by reference in their entirety. If multiple definitions exist for terms in this document, the definitions in this chapter shall prevail.

[0017] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0018] The definitions of standard chemical terms can be found in the reference "Pharmacopoeia of the People's Republic of China (2020 Edition), China Medical Science and Technology Press: May 2020: 1st Edition."

[0019] Unless otherwise stated, conventional methods within the scope of the art, such as mixing, decocting, separating, merging, and concentrating, shall be used.

[0020] Unless specifically defined herein, the use of all commercially available products herein employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0021] The term "active ingredient" as used in this article refers to a single natural ingredient extracted from traditional Chinese medicine, the content of which should account for more than 90% of the total extract.

[0022] As used herein, the term "pharmaceuticalally acceptable excipient" refers to pharmaceutically acceptable materials, such as liquid or solid fillers, stabilizers, dispersants, suspending agents, diluents, excipients, thickeners, solvents, or encapsulating materials, relating to the carrying or transport of any pharmaceutical composition from one organ or part of the body to another organ or part of the body. Each carrier must be "acceptable" in the sense of compatibility with other components of the pharmaceutical composition and harmlessness to the patient.

[0023] The term "decoction" as used in this article refers to the process of placing medicinal materials in a container, adding water, and boiling them to dissolve the active ingredients in the water through heating, thus forming a medicinal liquid.

[0024] In a first aspect, the present invention provides: a method for preparing a traditional Chinese medicine composition containing total saponins from Albizia bark, comprising the following steps:

[0025] S1: Albizia bark, floating wheat, and ethanol solution are mixed and extracted by reflux to obtain filter residue 1 and extract A. Extract A is concentrated to obtain component 1; the volume fraction of the ethanol solution is 55%-85%.

[0026] S2: Mix the filter residue 1 with Bupleurum, Curcuma and Salvia miltiorrhiza, and extract by reflux with ethanol solution of volume fraction of 20%-40% to obtain filter residue 2 and extract B. Concentrate extract B to obtain component 2.

[0027] S3: White peony root, schisandra fruit, licorice root, jujube and water are mixed, decocted, separated, and residue 3 and filtrate C are obtained. Filtrate C is concentrated to obtain component 3.

[0028] S4: Combine components 1, 2 and 3 to obtain an extract, and dry it.

[0029] These include technical features such as ethanol solution, reflux extraction, decoction, and extract.

[0030] In step S1, the technical feature of the ethanol solution is selected from those with a volume fraction of 55%-85%.

[0031] Any point value within the above numerical range, or the range between two points, can satisfy the technical effect of the present invention, including but not limited to: the volume fraction of the ethanol solution being 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, and 85%.

[0032] In step S1, the preferred technical feature of the ethanol solution is that the volume fraction of the ethanol solution is 65%-75%.

[0033] Any point value within the above numerical range or the range between two points can satisfy the technical effect of the present invention, and will not be elaborated here.

[0034] In step S1, the ethanol solution is further preferably characterized by having a volume fraction of 65%.

[0035] In step S1, the temperature for reflux extraction of technical features is selected from 65℃-85℃.

[0036] Any point value or range between two points within the above-mentioned numerical range can satisfy the technical effect of the present invention, including but not limited to: 65℃, 66℃, 67℃, 68℃, 69℃, 70℃, 71℃, 72℃, 73℃, 74℃, 75℃, 76℃, 77℃, 78℃, 79℃, 80℃, 81℃, 82℃, 83℃, 84℃, and 85℃.

[0037] In step S1, the temperature for reflux extraction of technical features is further preferably 75°C.

[0038] In step S1, the time for technical feature reflux extraction is selected from 1h-2.5h.

[0039] Any point value or range between two points within the above numerical range can satisfy the technical effect of the present invention, including but not limited to: 1h, 1.1h, 1.2h, 1.3h, 1.4h, 1.5h, 1.6h, 1.7h, 1.8h, 1.9h, 2.0h, 2.1h, 2.2h, 2.3h, 2.4h, and 2.5h.

[0040] In step S1, the preferred time for technical feature reflux extraction is 1h-2.0h.

[0041] Any point value within the above numerical range or the range between two points can satisfy the technical effect of the present invention, and will not be elaborated here.

[0042] In step S1, the time for technical feature reflux extraction is further preferably 1.5 hours.

[0043] Preferably, in step S1, the technical features are extracted backflow twice.

[0044] In step S1, the ratio of the total mass of Albizia bark and floating wheat to the ethanol solution is selected as 1 kg: 6-12 L.

[0045] Any point value or range between two points within the above numerical range can satisfy the technical effect of the present invention, including but not limited to: 1:6, 1:7, 1:8, 1:9, 1:10, 1:11, 1:12 (unit: kg:L).

[0046] In step S1, the preferred material-to-liquid ratio of the total mass of Albizia bark and floating wheat to the ethanol solution is 1 kg: 8-12 L.

[0047] Any point value within the above numerical range or the range between two points can satisfy the technical effect of the present invention, and will not be elaborated here.

[0048] In step S1, the ratio of the total mass of Albizia bark and floating wheat to the ethanol solution is further preferably 1 kg: 10 L.

[0049] In step S2, the technical feature of the ethanol solution is selected from those with a volume fraction of 20%-40%.

[0050] Any point value within the above numerical range or the range between two points can satisfy the technical effect of the present invention, including but not limited to: the volume fraction of the ethanol solution being 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, and 40%.

[0051] In step S2, the preferred technical feature of the ethanol solution is that the volume fraction of the ethanol solution is 30%.

[0052] Any point value within the above numerical range or the range between two points can satisfy the technical effect of the present invention, and will not be elaborated here.

[0053] In step S2, the temperature for reflux extraction of technical features is selected from 65℃-85℃.

[0054] Any point value or range between two points within the above-mentioned numerical range can satisfy the technical effect of the present invention, including but not limited to: 65℃, 66℃, 67℃, 68℃, 69℃, 70℃, 71℃, 72℃, 73℃, 74℃, 75℃, 76℃, 77℃, 78℃, 79℃, 80℃, 81℃, 82℃, 83℃, 84℃, and 85℃.

[0055] In step S2, the temperature for reflux extraction of technical features is further preferably 75°C.

[0056] In step S2, the time for technical feature reflux extraction is selected from 1h to 2.5h.

[0057] Any point value or range between two points within the above numerical range can satisfy the technical effect of the present invention, including but not limited to: 1h, 1.1h, 1.2h, 1.3h, 1.4h, 1.5h, 1.6h, 1.7h, 1.8h, 1.9h, 2.0h, 2.1h, 2.2h, 2.3h, 2.4h, and 2.5h.

[0058] In step S2, the preferred time for technical feature reflux extraction is 1h-2.0h.

[0059] Any point value within the above numerical range or the range between two points can satisfy the technical effect of the present invention, and will not be elaborated here.

[0060] In step S2, the time for technical feature reflux extraction is further preferably 1.5 hours.

[0061] Preferably, in step S2, the technical features are extracted backflow 2-3 times.

[0062] In step S2, the technical feature is reflux extraction. The material-to-liquid ratio for reflux extraction is selected as 1kg:6-12L, based on the total mass of Albizia bark, wheat bran, Bupleurum, Curcuma longa and Salvia miltiorrhiza.

[0063] Any point value or range between two points within the above numerical range can satisfy the technical effect of the present invention, including but not limited to 1:6, 1:7, 1:8, 1:9, 1:10, 1:11, and 1:12 (unit: kg:L).

[0064] In step S2, the technical feature is reflux extraction. The material-to-liquid ratio for reflux extraction is selected as 1kg:8-12L, based on the total mass of Albizia bark, wheat bran, Bupleurum, Curcuma longa and Salvia miltiorrhiza.

[0065] Any point value within the above numerical range or the range between two points can satisfy the technical effect of the present invention, and will not be elaborated here.

[0066] In step S2, the technical feature is reflux extraction, wherein the material-to-liquid ratio of the reflux extraction is 1kg:10L, based on the total mass of Albizia bark, floating wheat, Bupleurum, Curcuma longa and Salvia miltiorrhiza.

[0067] In step S3, the mass of the water is selected from: the mass of the water is 6-12 times the total mass of white peony root, schisandra fruit, licorice root and jujube.

[0068] Any point value or the range between two points within the above numerical range can satisfy the technical effect of the present invention, including but not limited to 6 times, 7 times, 8 times, 9 times, 10 times, 11 times, and 12 times.

[0069] In step S3, the cooking time is selected from 1h to 2.5h; the cooking is boiling.

[0070] Any point value or range between two points within the above numerical range can satisfy the technical effect of the present invention, including but not limited to 1h, 1.1h, 1.2h, 1.3h, 1.4h, 1.5h, 1.6h, 1.7h, 1.8h, 1.9h, 2.0h, 2.1h, 2.2h, 2.3h, 2.4h, and 2.5h.

[0071] In step S3, the technical feature is boiled 2-3 times.

[0072] In step S4, the technical feature extract is selected from extracts with a relative density of 1.02-1.40 at 40-60℃.

[0073] Any point value within the above numerical range or the range between two points can satisfy the technical effect of the present invention, and will not be elaborated here.

[0074] Preferably, step S4 further includes drying.

[0075] More preferably, the drying process is selected from vacuum drying, spray drying, freeze drying, vacuum drying, and fluidized bed drying, and the moisture content is dried to ≤8%.

[0076] More preferably, the drying is selected from spray drying or vacuum drying, and the moisture content is dried to ≤8%.

[0077] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 8-17 parts of Albizia bark, 15-30 parts of wheat bran, 6-14 parts of white peony root, 4-10 parts of Bupleurum root, 3-10 parts of Curcuma root, 4-10 parts of Salvia miltiorrhiza root, 3-9 parts of Schisandra fruit, 5-11 parts of jujube, and 3-10 parts of licorice root.

[0078] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-15 parts of Albizia bark, 20-25 parts of wheat bran, 7-12 parts of white peony root, 5-9 parts of Bupleurum root, 4-9 parts of Curcuma root, 5-9 parts of Salvia miltiorrhiza root, 4-7 parts of Schisandra fruit, 6-10 parts of jujube, and 4-9 parts of licorice root.

[0079] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 12 parts of Albizia bark, 21 parts of wheat bran, 9 parts of white peony root, 6 parts of Bupleurum root, 6 parts of Curcuma root, 6 parts of Salvia miltiorrhiza root, 6 parts of Schisandra fruit, 9 parts of jujube, and 6 parts of licorice root.

[0080] Preferably, the traditional Chinese medicine composition further includes dextrin.

[0081] More preferably, the mass of the dextrin is 15% of the total mass of Albizia bark, wheat bran, white peony root, Bupleurum root, turmeric, Salvia miltiorrhiza, Schisandra fruit, jujube, and licorice.

[0082] Secondly, the present invention provides a traditional Chinese medicine composition containing total saponins from Albizia bark prepared by the preparation method described above.

[0083] Thirdly, the present invention provides a formulation for treating anxiety, comprising a traditional Chinese medicine composition containing total saponins from Albizia bark prepared by the preparation method described above, and pharmaceutically acceptable excipients.

[0084] Preferably, the pharmaceutically acceptable excipients include, but are not limited to, soluble starch, polyvinylpyrrolidone K30, maltodextrin, aspartame, ethanol, mannitol, trehalose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, pregelatinized starch, corn starch, resistant dextrin, β-cyclodextrin, gum arabic, magnesium stearate, and silicon dioxide.

[0085] The present invention has at least the following beneficial effects:

[0086] The specific preparation method of this invention involves extracting Albizia bark and wheat bran with a high volume concentration of 55%-85% ethanol solution, followed by a secondary extraction of the resulting residue 1 with Bupleurum, Curcuma longa, and Salvia miltiorrhiza using a low concentration ethanol solution; then, Paeonia lactiflora, Schisandra chinensis, and jujube are mixed with water and decocted for extraction. Under specific extraction parameters, the content of effective components in the final traditional Chinese medicine composition is significantly increased, especially the content of saponins in Albizia bark, which solves the problems of poor water solubility and easy decomposition at high temperatures. The traditional Chinese medicine composition obtained by this preparation method has a significantly improved effect on the treatment of generalized anxiety disorder. Detailed Implementation

[0087] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0088] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0089] Example 1

[0090] A method for preparing a traditional Chinese medicine composition containing total saponins from Albizia bark, comprising the following steps:

[0091] S1: Mix and grind 12 parts of Albizia bark and 21 parts of floating wheat. Add 65% (v / v) ethanol solution at a material-to-liquid ratio of 1kg:10L and reflux extract at 75℃ for 1.5 hours. Reflux extract twice to obtain filter residue 1. Combine the residues to obtain extract A. Concentrate extract A to obtain component 1.

[0092] S2: The filter residue 1 from step S1 is mixed with 6 parts of Bupleurum, 6 parts of Curcuma longa, and 6 parts of Salvia miltiorrhiza. It is then refluxed and extracted with 30% (v / v) ethanol solution at a material-to-liquid ratio of 1kg:10L (based on the total mass of Albizia julibrissin bark, wheat bran, Bupleurum, Curcuma longa, and Salvia miltiorrhiza). The mixture is refluxed twice at 75℃ for 1.5 hours each time, yielding filter residue 2 and extract B. Extract B is then concentrated to obtain component 2.

[0093] S3: Mix 9 parts white peony root, 6 parts schisandra fruit, 9 parts jujube and 6 parts licorice root, add 10 times the amount of water and soak for 30 minutes, decoct twice, 1 hour each time, filter to obtain filtrate C and residue 3, concentrate filtrate C to obtain component 3.

[0094] S4: Combine components 1, 2 and 3 to obtain an extract with a relative density of 1.02-1.30. Add 15% of the total mass of the above medicinal materials as dextrin and stir until completely dissolved. Then spray dry and pass through an 80-mesh sieve to obtain a dry extract powder.

[0095] Example 2

[0096] A method for preparing a traditional Chinese medicine composition containing total saponins from Albizia bark, comprising the following steps:

[0097] S1: Mix and grind 12 parts of Albizia bark and 21 parts of floating wheat. Add 70% (v / v) ethanol solution at a material-to-liquid ratio of 1kg:10L and reflux at 80℃ for 1 hour. Reflux extraction is performed twice to obtain filter residue 1. Combine the residues to obtain extract A. Concentrate extract A to obtain component 1.

[0098] S2: The filter residue 1 from step S1 is mixed with 6 parts of Bupleurum, 6 parts of Curcuma longa, and 6 parts of Salvia miltiorrhiza. The mixture is then refluxed with a 30% (v / v) ethanol solution at a material-to-liquid ratio of 1 kg:10 L (based on the total mass of Albizia julibrissin bark, Triticum aestivum, Bupleurum, Curcuma longa, and Salvia miltiorrhiza). The mixture is refluxed twice at 70°C for 1.5 hours each time, yielding filter residue 2 and extract B. Extract B is then concentrated to obtain component 2.

[0099] S3: Mix 9 parts of white peony root, 6 parts of schisandra fruit, 9 parts of jujube and 6 parts of licorice root, add 6 times the amount of water and soak for 30 minutes, decoct twice, 1.5 hours each time, filter to obtain filtrate C and residue 3, concentrate filtrate C to obtain component 3;

[0100] S4: Combine components 1, 2 and 3, concentrate to a relative density of 1.30-1.40, add 15% of the total mass of the above medicinal materials with dextrin and stir until completely dissolved, then vacuum dry and pass through an 80-mesh sieve to obtain a dry extract powder.

[0101] Example 3

[0102] A method for preparing a traditional Chinese medicine composition containing total saponins from Albizia bark, comprising the following steps:

[0103] S1: Mix and grind 12 parts of Albizia bark and 21 parts of floating wheat. Add 55% (v / v) ethanol solution at a material-to-liquid ratio of 1kg:6L and reflux extract at 85℃ for 2.5 hours. Reflux extract twice to obtain filter residue 1. Combine the residues to obtain extract A. Concentrate extract A to obtain component 1.

[0104] S2: The filter residue 1 from step S1 is mixed with 6 parts of Bupleurum, 6 parts of Curcuma longa, and 6 parts of Salvia miltiorrhiza. 20% (v / v) ethanol solution is used for reflux extraction at a material-to-liquid ratio of 1 kg:12 L (based on the total mass of Albizia julibrissin bark, wheat bran, Bupleurum, Curcuma longa and Salvia miltiorrhiza). Reflux extraction is performed twice at 85℃, 1 hour each time. Filter residue 2 and extract B are then mixed. Extract B is concentrated to obtain component 2.

[0105] S3: Mix 9 parts of white peony root, 6 parts of schisandra fruit, 9 parts of jujube and 6 parts of licorice root, add 12 times the amount of water and soak for 30 minutes, decoct twice, 1 hour each time, filter to obtain filtrate C and residue 3, concentrate filtrate C to obtain component 3.

[0106] S4: Combine components 1, 2 and 3 to obtain an extract with a relative density of 1.02-1.30. Add 15% of the total mass of the above medicinal materials as dextrin and stir until completely dissolved. Then spray dry and pass through an 80-mesh sieve to obtain a dry extract powder.

[0107] Example 4

[0108] A method for preparing a traditional Chinese medicine composition containing total saponins from Albizia bark, comprising the following steps:

[0109] S1: Mix and grind 12 parts of Albizia bark and 21 parts of floating wheat. Add 85% (v / v) ethanol solution at a material-to-liquid ratio of 1kg:12L and reflux extract at 65℃ for 2 hours. Reflux extract twice to obtain filter residue 1. Combine the residues to obtain extract A. Concentrate extract A to obtain component 1.

[0110] S2: The filter residue 1 from step S1 is mixed with 6 parts of Bupleurum, 6 parts of Curcuma longa, and 6 parts of Salvia miltiorrhiza. It is then refluxed and extracted with 40% (v / v) ethanol solution at a material-to-liquid ratio of 1 kg:10 L (based on the total mass of Albizia julibrissin bark, wheat bran, Bupleurum, Curcuma longa, and Salvia miltiorrhiza). The mixture is refluxed twice at 65℃ for 2.5 hours each time, yielding filter residue 2 and extract B. Extract B is then concentrated to obtain component 2.

[0111] S3: Mix 9 parts of white peony root, 6 parts of schisandra fruit, 9 parts of jujube and 6 parts of licorice root, add 8 times the amount of water and soak for 30 minutes, decoct twice, 2.5 hours each time, filter to obtain filtrate C and residue 3, concentrate filtrate C to obtain component 3;

[0112] S4: Combine components 1, 2 and 3 to obtain an extract with a relative density of 1.30-1.40. Add 15% of the total mass of the above medicinal materials with dextrin and stir until completely dissolved. Then vacuum dry and pass through an 80-mesh sieve to obtain a dry extract powder.

[0113] Comparative Example 1

[0114] A method for preparing a traditional Chinese medicine composition containing total saponins from Albizia bark, differing from Example 1 in that the concentration of the ethanol solution in step S1 is different, specifically:

[0115] S1: Mix and grind 12 parts of Albizia bark and 21 parts of floating wheat. Add 95% (v / v) ethanol solution at a material-to-liquid ratio of 1kg:10L and reflux extract at 75℃ for 1.5 hours. Reflux extract twice to obtain filter residue 1. Combine the residues to obtain extract A. Concentrate extract A to obtain component 1.

[0116] Steps S2-S4 are the same as in Example 1.

[0117] Comparative Example 2

[0118] A method for preparing a traditional Chinese medicine composition containing total saponins from Albizia bark, comprising the following steps:

[0119] S1: Mix and pulverize 12 parts of Albizia bark, 9 parts of white peony root, 6 parts of Schisandra chinensis, 6 parts of Bupleurum chinense, and 6 parts of Curcuma longa. Add 65% (v / v) ethanol solution at a material-to-liquid ratio of 1kg:10L and reflux at 75℃ for 1.5 hours. Reflux extraction is performed twice to obtain filter residue 1. Combine the residues to obtain extract A. Concentrate extract A to obtain component 1.

[0120] S2: The filter residue 1 from step S1 and 6 parts of Salvia miltiorrhiza were mixed and extracted by reflux with 30% (v / v) ethanol solution at a material-to-liquid ratio of 1kg:10L (based on the total mass of Albizia julibrissin bark, Paeonia lactiflora, Schisandra chinensis, Bupleurum chinense, Curcuma longa and Salvia miltiorrhiza). The mixture was refluxed twice at 75℃ for 1.5 hours each time to obtain filter residue 2 and extract B. Extract B was concentrated to obtain component 2.

[0121] S3: Mix 9 parts white peony root, 9 parts jujube and 6 parts licorice root, add 10 times the amount of water and soak for 30 minutes, decoct twice, 1 hour each time, filter, and obtain filtrate C and residue 3. Concentrate filtrate C to obtain component 3.

[0122] S4: Combine components 1, 2 and 3 to obtain an extract with a relative density of 1.02-1.30. Add 15% of the total mass of the above medicinal materials as dextrin and stir until completely dissolved. Then spray dry and pass through an 80-mesh sieve to obtain a dry extract powder.

[0123] Comparative Example 3

[0124] A method for preparing a traditional Chinese medicine composition containing total saponins from Albizia bark, differing from Example 1 in that it does not involve a two-step alcohol extraction. Specifically:

[0125] S1: Mix and grind 12 parts of Albizia bark and 21 parts of floating wheat. Add 65% (v / v) ethanol solution at a material-to-liquid ratio of 1kg:10L and reflux extract at 75℃ for 1.5 hours. Reflux extract twice to obtain filter residue 1. Combine the residues to obtain extract A. Concentrate extract A to obtain component 1.

[0126] S2: The residue 1 from step S1 is mixed with 6 parts of Bupleurum, 6 parts of Curcuma longa, 6 parts of Salvia miltiorrhiza, 9 parts of Paeonia lactiflora, 6 parts of Schisandra chinensis, 9 parts of Jujube and 6 parts of Glycyrrhiza uralensis. Add water equivalent to 10 times the total mass of all raw materials and soak for 30 minutes. Decoction is carried out 4 times, 1 hour each time. Filter to obtain filtrate and residue. Concentrate the filtrate to obtain component 2.

[0127] S3: Combine components 1 and 2 to obtain an extract with a relative density of 1.02-1.30. Add 15% of the total mass of the above medicinal materials with dextrin and stir until completely dissolved. Then spray dry and pass through an 80-mesh sieve to obtain a dry extract powder.

[0128] Test Example 1

[0129] The content of (I) eugenol-4-O-β-D-furanotropic glycoside in the traditional Chinese medicine compositions prepared in Examples 1-4 and Comparative Examples 1-3.

[0130] Test method: The test was conducted according to the method for detecting the content of (-)-eugenol-4-O-β-D-furanoside-(1→2)-β-D-glucopyranoside in Albizia bark as recorded in the 2020 edition of the Chinese Pharmacopoeia.

[0131] The data is shown in Table 1 below:

[0132] Table 1. Content

[0133]

[0134] As shown in Table 1, compared with the comparative example, the content of (-)-eugenol-4-O-β-D-furanoside in the traditional Chinese medicine composition prepared by the specific preparation method of the present invention is significantly increased.

[0135] Test Example 2

[0136] Effects of mCPP (m-chloropiperazine) on anxiety-like behavior in mice

[0137] 1. Modeling and Drug Administration: After acclimatization, 100 male C57BL / 6 mice (SPF grade, 35-48 days old; Animal Certificate No.: 20250627Abzz06190000122; Source of experimental animals: Zhejiang Vital River Laboratory Animal Technology Co., Ltd.; Laboratory Animal Production License No.: SCXK (Su) 2024-0001; Laboratory Animal Use License No.: SYXK (Su) 2021-0065) were randomly divided into a normal control group (n=10) and a modeling group (n=90) according to body weight. The modeling group was then randomly divided into a model group, a positive control group (diazepam tablets), Example 1 group, Example 2 group, Example 3 group, Example 4 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group, with 10 mice in each group. Except for the normal control group and the model group, which were given 10.65 g / kg of double-distilled water, all other treatment groups were given 10.65 g / kg of the test substance (traditional Chinese medicine composition) once a day for 14 consecutive days. After the last administration, except for the normal control group, the mice in the other groups were intraperitoneally injected with mCPP (m-chloropiperazine) at a dose of 4 mg / kg to induce anxiety-like behavior in the mice.

[0138] 2. Open field experiment: Conduct an open field experiment and statistically analyze the percentage of central distance (%) and percentage of central time (%) for each group based on the software.

[0139] Central Distance Percentage (%) = Central Area Distance / Total Distance × 100%;

[0140] Central time percentage (%) = Central area exercise time / Total exercise time × 100%.

[0141] 3. Results are expressed as mean ± standard deviation. Pairwise comparisons between groups were performed using t-tests. P < 0.05 was considered statistically significant.

[0142] 4. The percentage of central distance and central time for each group of mice in the open field experiment are shown in Table 2.

[0143] Table 2. Results of the open field experiment (n=10)

[0144]

[0145] Table 2 shows the comparison between the model group and the normal control group. # P<0.05, ## P < 0.01 indicates successful model establishment; comparisons between experimental groups and the model group show... & P<0.05,&& P<0.05; compared with Example 1 group, % P<0.05.

[0146] 1# Calculated by diazepam content.

[0147] As shown in Table 2, compared with the normal control group, the central distance percentage and central time percentage of the model group were significantly reduced (P < 0.01), indicating that intraperitoneal injection of mCPP (m-chloropiperazine) induced significant anxiety-like behavior in mice, and the model was successfully established. Compared with the model group, the central distance percentage and central time percentage of the positive control group, the example group, and the comparative group increased, suggesting that the anxiety-like behavior in mice was improved. Specifically, the central distance percentage and central time percentage of the example group of this invention were significantly increased, showing a significant effect of improving anxiety compared with the model group (P < 0.01). The central distance percentage and central time percentage of the composition in the comparative group were inferior to those in the example group (P < 0.05). This indicates that although the comparative group with modified preparation method has a certain anti-anxiety effect, its effect on improving mCPP-induced anxiety-like behavior in mice is significantly lower than that in the example group, and the preparation method of this invention achieves a better effect in improving anxiety.

[0148] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A method for preparing a traditional Chinese medicine composition containing total saponins of Albizia julibrissin, characterized in that, Includes the following steps: S1: Albizia bark, floating wheat, and ethanol solution are mixed and extracted by reflux to obtain filter residue 1 and extract A. Extract A is concentrated to obtain component 1; the volume fraction of the ethanol solution is 55%-85%. S2: Mix the filter residue 1 with Bupleurum, Curcuma and Salvia miltiorrhiza, and extract by reflux with ethanol solution of volume fraction of 20%-40% to obtain filter residue 2 and extract B. Concentrate extract B to obtain component 2. S3: White peony root, schisandra fruit, licorice root, jujube and water are mixed, decocted, separated, and residue 3 and filtrate C are obtained. Filtrate C is concentrated to obtain component 3. S4: Combine components 1, 2 and 3 to obtain an extract, and dry it; The traditional Chinese medicine composition in the preparation method comprises the following raw materials by weight: 8-17 parts of Albizia bark, 15-30 parts of wheat bran, 6-14 parts of white peony root, 4-10 parts of Bupleurum root, 3-10 parts of Curcuma root, 4-10 parts of Salvia miltiorrhiza root, 3-9 parts of Schisandra fruit, 5-11 parts of jujube, and 3-10 parts of licorice root.

2. The preparation method according to claim 1, characterized in that, In step S1, the volume fraction of the ethanol solution is 65%-75%.

3. The preparation method according to claim 1, characterized in that, In step S1, the reflux extraction temperature is 65℃-85℃; the reflux extraction time is 1h-2.5h, and the number of extractions is 2; the total mass of Albizia bark and floating wheat to the ethanol solution is 1kg:6-12L.

4. The preparation method according to claim 1, characterized in that, In step S2, the volume fraction of the ethanol solution is 30%.

5. The preparation method according to claim 1, characterized in that, In step S2, the extraction temperature is 65℃-85℃ and the extraction time is 1h-2.5h. During the extraction process, the total mass of Albizia bark, wheat bran, Bupleurum, Curcuma longa and Salvia miltiorrhiza are used as the standard, and the extraction material-to-liquid ratio is 1kg:6-12L.

6. The preparation method according to claim 1, characterized in that, In step S3, the mass of the water is 6-12 times the total mass of white peony root, schisandra fruit, licorice root, and jujube; the decoction is performed 2-3 times, and each decoction lasts for 1-2.5 hours.

7. The preparation method according to claim 1, characterized in that, In step S4, the relative density of the extract at 40-60°C is 1.02-1.

40.

8. The traditional Chinese medicine composition containing total saponins from Albizia bark prepared by the preparation method according to any one of claims 1-7.

9. A formulation for treating anxiety, characterized in that, The traditional Chinese medicine composition containing total saponins from Albizia bark, prepared by the preparation method according to any one of claims 1-7, and pharmaceutically acceptable excipients.

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