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CN-121987684-A - Traditional Chinese medicine composition for strengthening spleen and clearing liver and preparation method thereof

CN121987684ACN 121987684 ACN121987684 ACN 121987684ACN-121987684-A

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, and discloses a traditional Chinese medicine composition for strengthening spleen and clearing liver and a preparation method thereof, wherein the composition comprises 20-40:60-80 parts by weight of core components and auxiliary components, the core components are micromolecular active component enrichment matters obtained after specific probiotics (bifidobacterium and lactobacillus) metabolize spleen-strengthening and liver-clearing classical traditional Chinese medicine mixtures, the total content of phenolic acids and flavonoid aglycone components is more than or equal to 80%, and the auxiliary components are water extraction and alcohol precipitation extracts of the traditional Chinese medicine mixtures. According to the invention, by simulating the intestinal environment of a human body, in-vitro pretreatment is carried out on the traditional Chinese medicine by adopting specific probiotics, and the micromolecule active ingredients with high bioavailability are actively enriched, so that the absorption efficiency of the pharmacodynamic ingredients and the intestinal-hepatic axis targeting are obviously improved; the method effectively solves the problem of drug effect fluctuation of the traditional Chinese medicine preparation caused by individual intestinal flora difference, and improves the stability of the curative effect and individual adaptability of the medicine.

Inventors

  • QI WENYING

Assignees

  • 北京中医药大学东直门医院

Dates

Publication Date
20260508
Application Date
20260227

Claims (7)

  1. 1. A traditional Chinese medicine composition for strengthening spleen and clearing liver is characterized by comprising 20-40 parts by weight of core components and 60-80 parts by weight of auxiliary components; The core component is a micromolecular active component enrichment obtained after a classical traditional Chinese medicine mixture for strengthening spleen and clearing liver by metabolism of specific probiotics, wherein the total content of phenolic acids and flavonoid aglycone components is more than or equal to 80 percent, and the phenolic acids and the flavonoid aglycone components comprise at least 6 of gallic acid, protocatechuic acid, caffeic acid, quercetin, kaempferol, chlorogenic acid metabolite, tanshinol and protocatechuic aldehyde, and the total proportion of the components in the core component is more than or equal to 60 percent; The auxiliary component is an aqueous extraction and alcohol precipitation extract of the spleen-strengthening and liver-clearing classical Chinese medicine mixture; The specific probiotics are complex bacterial groups of bifidobacterium and lactobacillus, and the total viable count is more than or equal to 1 multiplied by 10 9 CFU/mL; the spleen-invigorating and liver-clearing classical traditional Chinese medicine mixture consists of, by weight, 15-25 parts of bighead atractylodes rhizome, 15-25 parts of poria cocos, 10-20 parts of radix bupleuri, 20-40 parts of herba artemisiae capillaris, 15-25 parts of radix salviae miltiorrhizae, 10-20 parts of radix paeoniae alba and 5-10 parts of liquorice.
  2. 2. The Chinese medicinal composition for invigorating spleen and clearing liver according to claim 1, wherein the specific probiotics comprise at least two of bifidobacterium longum, bifidobacterium animalis, lactobacillus acidophilus, lactobacillus casei, bifidobacterium adolescentis and lactobacillus plantarum, and the ratio of viable bacteria to viable bacteria among the probiotics is 1:1-3.
  3. 3. The Chinese medicinal composition for invigorating spleen and clearing liver as claimed in claim 2, wherein the probiotic bacteria of the genus bifidobacterium are preferably bifidobacterium adolescentis or bifidobacterium longum, and the probiotic bacteria of the genus lactobacillus are preferably lactobacillus plantarum or lactobacillus casei.
  4. 4. A preparation method of a traditional Chinese medicine composition for invigorating spleen and clearing liver, which is based on any one of claims 1-3, and is characterized by comprising the following steps: (1) Decocting the spleen-invigorating and liver-clearing classical Chinese medicinal mixture with water, filtering, concentrating until the crude drug concentration is 0.5-1g/mL to obtain Chinese medicinal mixture extract, sequentially incubating the extract with artificial gastric juice (pH 1.5-2.0) and artificial intestinal juice (pH 6.8-7.2) for 1-2 hr, simulating gastrointestinal digestion, mixing with specific probiotic seed solution at volume ratio of 1:5, constructing an in vitro anaerobic metabolism system, anaerobic culturing at pH 6.5-7.0 for 24-48 hr at 37 deg.C with concentration of 1×10 7 –1×10 9 CFU/mL, centrifuging to remove thallus, purifying supernatant by macroporous adsorption resin chromatography, and lyophilizing eluate to obtain core component; (2) Decocting the spleen-invigorating and liver-clearing classical Chinese medicine mixture with water, precipitating with ethanol to remove impurities, concentrating, and drying to obtain water-extracted and ethanol-precipitated extract, namely an auxiliary component; (3) Mixing the core component and the auxiliary component according to the weight part of 20-40:60-80, adding the medicinal auxiliary materials, and uniformly stirring to obtain a composition intermediate; (4) Making the composition intermediate into granule or oral liquid.
  5. 5. The method for preparing a traditional Chinese medicine composition for invigorating spleen and clearing liver as claimed in claim 4, wherein in the step (4), the auxiliary materials used in the granules are lactose, the dosage of the auxiliary materials is 30% -50% of the weight of the composition intermediate, and the auxiliary materials used in the oral liquid comprise stevioside and sodium benzoate, and the dosage of the auxiliary materials is 0.1% -0.2% and 0.05% -0.1% of the total weight of a final preparation system respectively.
  6. 6. Use of a Chinese medicinal composition according to any one of claims 1-3 for the preparation of a medicament for invigorating spleen and clearing liver, wherein the medicament exerts a therapeutic effect by targeting the intestine-liver axis for the treatment of liver diseases which are of the type of liver depression and spleen deficiency, incoordination between liver and spleen or spleen deficiency and liver depression with damp-heat accumulation.
  7. 7. The use according to claim 6, wherein the liver disease is non-alcoholic fatty liver disease, chronic viral hepatitis b or drug-induced liver injury.

Description

Traditional Chinese medicine composition for strengthening spleen and clearing liver and preparation method thereof Technical Field The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition for strengthening spleen and clearing liver and a preparation method thereof. Background The Chinese herbal compound for strengthening the spleen and clearing liver is widely applied to the treatment of liver depression and spleen deficiency, incoordination between the liver and spleen and other symptoms in clinic, has the core effects of regulating spleen and stomach transportation and transformation function, clearing liver fire, soothing liver and regulating qi, adopts white atractylodes rhizome, poria cocos, radix bupleuri, herba artemisiae, radix salviae miltiorrhizae and the like as core medicinal materials in classical compatibility, and relies on the principle of monarch, minister and minister assistance of Chinese herbal medicines to realize overall syndrome differentiation treatment, and has the advantages that the medicinal material basis of the compound is mainly active ingredients such as flavonoids, phenolic acids, terpenes and the like, but has lower bioavailability, poor medicinal effect stability, obvious individual curative effect difference and the like, and long-term restricts the clinical application effect. In the prior art, the traditional extraction technology (such as water decoction, alcohol extraction, ultrasonic extraction and the like) is mainly adopted for preparing the spleen-strengthening and liver-clearing traditional Chinese medicine preparation, and raw material extracts are directly used as raw materials to prepare the preparation such as granules, oral liquid and the like, so that only the retention of raw components is concerned, and the metabolic conversion effect of the intestinal flora of the human body on the traditional Chinese medicine active ingredients is not considered. Research shows that after the Chinese herbal medicine compound enters a human body, most of macromolecular active ingredients are required to be metabolized and converted into micromolecular active substances (such as phenolic acid, flavonoid aglycone and the like) through intestinal flora and can be absorbed and utilized, and individual differences of the intestinal flora composition can cause obvious differences of the types and the contents of metabolic products of the same Chinese herbal medicine compound in different human bodies, so that the problems of fluctuation of the drug effect and poor individual adaptability are caused. At present, the traditional Chinese medicine compound preparation on the market does not adopt an individual intestinal flora metabolism guidance design, lacks accurate regulation and control on interaction of intestinal flora and traditional Chinese medicine components, cannot realize synergistic effect of original formula efficacy retention and metabolite synergy, and also cannot solve core pain points of efficacy stability and individual adaptability, so that development of a traditional Chinese medicine composition for strengthening spleen and clearing liver, which is based on intestinal flora metabolism guidance, targeting intestinal-liver axis and has high efficacy and high adaptability, becomes a technical problem to be solved in the field. Disclosure of Invention (One) solving the technical problems Aiming at the defects of the prior art, the invention provides a traditional Chinese medicine composition for strengthening spleen and clearing liver and a preparation method thereof, which have the advantages of being based on intestinal flora metabolism guiding design, accurately enriching high-activity micromolecular metabolites, remarkably improving bioavailability of medicinal components, intestinal-liver axis targeting, enhancing clinical curative effect stability and individual adaptability and the like, and solve the technical problems that the traditional spleen strengthening liver clearing compound has large medicinal effect fluctuation, low absorption rate of the effective components and lack of active regulation and control mechanism of metabolites due to the fact that the traditional spleen strengthening liver clearing compound depends on individual intestinal flora difference, and the existing commercial products do not realize 'prodrug-metabolism synergy' accurate compatibility. (II) technical scheme In order to realize the aim of providing the spleen-strengthening and liver-clearing traditional Chinese medicine composition with high bioavailability and intestinal-liver axis targeting based on intestinal flora metabolism guidance and a controllable and repeatable preparation method thereof, the invention provides the following technical scheme that the spleen-strengthening and liver-clearing traditional Chinese medicine composition consists of a core component and an aux