CN-122005694-A - Traditional Chinese medicine composition for treating functional dyspepsia, preparation thereof and preparation method of preparation

CN122005694ACN 122005694 ACN122005694 ACN 122005694ACN-122005694-A

Abstract

The invention relates to the technical field of medicines, in particular to a traditional Chinese medicine composition for treating functional dyspepsia, a preparation thereof and a preparation method of the preparation, the traditional Chinese medicine composition comprises, by weight, 8-12 parts of codonopsis pilosula, 8-12 parts of poria cocos, 8-12 parts of pinellia ternate, 8-12 parts of honey-fried licorice root, 8-12 parts of dried orange peel, 15-25 parts of raw bighead atractylodes rhizome, 3-6 parts of coptis chinensis, 25-35 parts of dandelion, 15-25 parts of eupatorium, 8-12 parts of magnolia officinalis, 8-12 parts of immature bitter orange, 9-12 parts of costustoot, 15-25 parts of cuttlebone and 10-20 parts of fried chicken gizzard-skin. The traditional Chinese medicine composition for treating functional dyspepsia, the preparation and the preparation method thereof are suitable for treating spleen deficiency and qi stagnation and spleen and stomach damp-heat type functional dyspepsia, and can synchronously improve pathological states such as gastrointestinal motility disorder, intestinal flora disorder, mucous membrane injury, intestinal brain interaction abnormality and the like.

Inventors

BAI MIN
CHENG YINGXIA
LIU MENGYA
DUAN YONGQIANG
HU JUNRUI
LU HAIRUI

Assignees

宁夏医科大学

Dates

Publication Date: 20260512
Application Date: 20260319

Claims (10)

1. The traditional Chinese medicine composition for treating functional dyspepsia is characterized by comprising, by weight, 8-12 parts of codonopsis pilosula, 8-12 parts of poria cocos, 8-12 parts of pinellia ternate, 8-12 parts of honey-fried licorice roots, 8-12 parts of dried orange peel, 15-25 parts of raw bighead atractylodes rhizome, 3-6 parts of coptis chinensis, 25-35 parts of dandelion, 15-25 parts of eupatorium, 8-12 parts of magnolia officinalis, 8-12 parts of immature bitter orange, 9-12 parts of costustoot, 15-25 parts of cuttlebone and 10-20 parts of fried chicken gizzard-skin.
2. A traditional Chinese medicine preparation for treating functional dyspepsia is characterized by comprising the traditional Chinese medicine composition for treating functional dyspepsia according to claim 1, wherein the traditional Chinese medicine preparation is in the form of a tablet, a capsule or a granule, the traditional Chinese medicine preparation is prepared from traditional Chinese medicine particles with a three-layer structure, the traditional Chinese medicine particles sequentially comprise an inner core layer, an intermediate functional buffer layer and an outer response shell layer from inside to outside, the inner core layer is prepared from a composite extract of the traditional Chinese medicine composition according to claim 1, the intermediate functional buffer layer is a calcium alginate gel layer containing a mucous membrane repair and barrier enhancing component and a pH buffer pair, and the outer response shell layer is a coating layer containing a pH response material.
3. The traditional Chinese medicine preparation for treating functional dyspepsia according to claim 2, wherein the mucosa repair and barrier enhancement component consists of bletilla striata polysaccharide, glutamine and L-arginine in a mass ratio of (2.5-3.5) (1.5-2.5) (0.8-1.2).
4. The Chinese medicinal preparation for treating functional dyspepsia according to claim 2, wherein the pH buffer pair is sodium dihydrogen phosphate-disodium hydrogen phosphate, and the buffer capacity is 10-50 mmol/L.
5. The Chinese medicinal preparation for treating functional dyspepsia according to claim 2, wherein the pH responsive material is one or more of methacrylic acid-ethyl acrylate copolymer and methacrylic acid-methyl methacrylate copolymer.
6. The method for preparing the traditional Chinese medicine preparation for treating functional dyspepsia according to any one of claims 2-5, wherein the method comprises the following steps: S1, extracting a traditional Chinese medicine compound extract, namely decocting radix codonopsis pilosulae, poria cocos, honey-fried licorice root, dried orange peel, pinellia tuber, raw bighead atractylodes rhizome, magnolia officinalis, immature bitter orange, costustoot, cuttlebone and fried chicken' S gizzard-skin with water to obtain an aqueous extract, reflux-extracting coptis chinensis, dandelion and eupatorium with ethanol to obtain an alcoholic extract, mixing the aqueous extract and the alcoholic extract, and spray-drying to obtain a traditional Chinese medicine compound extract dry powder; s2, preparing a mucosa repair and barrier enhancement component, namely mixing and grinding bletilla striata polysaccharide, glutamine and L-arginine, and adding a dispersing agent to prepare a mucosa repair and barrier enhancement component powder; S3, constructing an intermediate function buffer layer, namely preparing a sodium alginate solution containing a pH buffer pair, mixing the dried powder of the traditional Chinese medicine composite extract of S1, the powder of the mucosa repair and barrier enhancement component of S2 and the sodium alginate solution containing the pH buffer pair, and injecting the mixture into a calcium chloride solution for ionic crosslinking to form a calcium alginate gel layer; S4, preparing an outer response shell layer, namely preparing coating liquid containing the pH response material, and spraying and coating the coating liquid on the surface of the calcium alginate gel layer of S3 by adopting a fluidized bed coating technology to obtain traditional Chinese medicine particles; s5, the preparation is molded, namely the traditional Chinese medicine granules and the pharmaceutic adjuvant are mixed and pressed into tablets, filled into capsules or granulated to obtain granules.
7. The method for preparing the traditional Chinese medicine preparation for treating functional dyspepsia according to claim 6, wherein in S1, spray drying is carried out under the conditions of 170-190 ℃ of air inlet temperature, 75-85 ℃ of air outlet temperature and 5-10 mL/min of feeding speed.
8. The method for preparing a Chinese medicinal preparation for treating functional dyspepsia according to claim 6, wherein in S2, the dispersing agent comprises one of polyethylene glycol 4000, polyethylene glycol 8000 or tween 80, and the mass of the dispersing agent is 0.5% -12% of the powder of the mucosa repair and barrier enhancement components.
9. The method for preparing the traditional Chinese medicine preparation for treating functional dyspepsia according to claim 6, wherein in S3, a sodium alginate solution containing a pH buffer pair is prepared by mixing sodium alginate with 2% -8% of sodium dihydrogen phosphate-disodium hydrogen phosphate buffer solution by mass percent, stirring and dissolving to obtain a sodium alginate solution containing the pH buffer pair, wherein the sodium alginate solution contains 1.5% -3.0% of sodium alginate by mass percent, the calcium chloride solution contains 0.5% -5.0% of sodium chloride by mass percent, and the ionic crosslinking time is 10-60 min.
10. The method for preparing a traditional Chinese medicine preparation for treating functional dyspepsia according to claim 6, wherein in S4, the coating liquid containing the pH response material is prepared by mixing the pH response material with a mixed solution of ethanol and water, adding 0.5% -2.0% of plasticizer by mass, stirring and dissolving, and preparing the coating liquid with the mass fraction of 5% -15%.

Description

Traditional Chinese medicine composition for treating functional dyspepsia, preparation thereof and preparation method of preparation Technical Field The invention relates to the technical field of medicines, in particular to a traditional Chinese medicine composition for treating functional dyspepsia, a preparation thereof and a preparation method of the preparation. Background Functional Dyspepsia (FD) is a clinically common intestinal-brain interaction abnormal disease, and takes postprandial fullness, early satiety, epigastric fullness, epigastric burning and the like as core symptoms, the global incidence rate reaches 8% -23%, wherein Postprandial Discomfort Syndrome (PDS) is a main subtype, and accounts for about 61% of all FD. Clinical studies indicate that FD patients often combine excessive growth of Small Intestine Bacteria (SIBO), helicobacter pylori infection, low inflammation of the duodenum and damage of the mucosal barrier, and most patients are accompanied with emotional problems such as anxiety and depression, forming malignant circulation of spleen deficiency-damp heat-qi stagnation-mucosal damage-dysbacteriosis. At present, western medicine treatment mainly uses combined medicines such as prokinetic medicines, probiotics, acid inhibitors and the like, but has the problems of limited curative effect, easy recurrence, more adverse reactions and the like. For example, long-term use of proton pump inhibitors may trigger osteoporosis, prokinetic drugs may cause arrhythmia, and antibiotic treatment of SIBO is prone to disruption of intestinal flora balance and development of drug resistance. The traditional Chinese medicine belongs to the stomach fullness category, the core pathogenesis is spleen deficiency, qi stagnation and damp-heat accumulation, and although classical formulas such as Lianpuyin and Zhishuangzhong capsules and Chinese patent medicines are applied, the traditional preparation has the defects of low bioavailability, easily damaged active ingredients by gastric acid, insufficient targeting and the like, and the single formula is difficult to cover the complex pathogenesis of the FD. Disclosure of Invention The invention aims to provide a traditional Chinese medicine composition for treating functional dyspepsia, a preparation thereof and a preparation method thereof, which are suitable for treating spleen deficiency and qi stagnation and spleen and stomach damp-heat type functional dyspepsia, and can synchronously improve pathological states such as gastrointestinal motility disorder, intestinal flora disorder, mucous membrane injury, intestinal brain interaction abnormality and the like. The traditional Chinese medicine composition comprises, by weight, 8-12 parts of codonopsis pilosula, 8-12 parts of poria cocos, 8-12 parts of pinellia ternate, 8-12 parts of honey-fried licorice root, 8-12 parts of dried orange peel, 15-25 parts of raw bighead atractylodes rhizome, 3-6 parts of coptis chinensis, 25-35 parts of dandelion, 15-25 parts of eupatorium, 8-12 parts of magnolia officinalis, 8-12 parts of immature bitter orange, 9-12 parts of costustoot, 15-25 parts of cuttlebone and 10-20 parts of fried chicken gizzard-skin. The invention also provides a traditional Chinese medicine preparation for treating functional dyspepsia, which comprises the traditional Chinese medicine composition for treating functional dyspepsia, wherein the traditional Chinese medicine preparation is in the form of a tablet, a capsule or a granule, the traditional Chinese medicine preparation is prepared from traditional Chinese medicine particles with a three-layer structure, the traditional Chinese medicine particles sequentially comprise an inner core layer, an intermediate functional buffer layer and an outer response shell layer from inside to outside, the inner core layer is prepared from a composite extract of the traditional Chinese medicine composition, the intermediate functional buffer layer is a calcium alginate gel layer containing a mucous membrane repair and barrier enhancement component and a pH buffer pair, and the outer response shell layer is a coating layer containing a pH response material. Preferably, the mucosa repair and barrier enhancement component consists of bletilla polysaccharide, glutamine and L-arginine in a mass ratio of (2.5-3.5) (1.5-2.5) (0.8-1.2). Preferably, the pH buffer pair is sodium dihydrogen phosphate-disodium hydrogen phosphate, and the buffer capacity is 10-50 mmol/L. Preferably, the pH responsive material is one or more of methacrylic acid-ethyl acrylate copolymer, methacrylic acid-methyl methacrylate copolymer. The invention also provides a preparation method of the traditional Chinese medicine preparation for treating functional dyspepsia, which comprises the following steps: S1, extracting a traditional Chinese medicine compound extract, namely decocting radix codonopsis pilosulae, poria cocos, honey-fried licorice root, dried orange peel, pinellia tuber, r