CN114191522A - Pharmaceutical composition and preparation for treating functional dyspepsia and preparation method thereof - Google Patents
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Abstract
The invention discloses a pharmaceutical composition for treating functional dyspepsia, a preparation and a preparation method thereof, wherein the pharmaceutical composition comprises the following components: radix Codonopsis, cortex Magnolia officinalis, Atractylodis rhizoma parched with bran, lignum Dalbergiae Odoriferae, rhizoma Pinelliae Preparata, fructus Amomi, rhizoma corydalis processed with vinegar and fructus crataegi preparata. The traditional Chinese medicine composition provided by the invention can be used for treating symptoms such as epigastric stuffiness, fullness or pain, anorexia, belching, gastric upset, fatigue, weakness, epigastric scorching and the like caused by spleen deficiency and qi stagnation; and functional dyspepsia with the symptoms, and has good clinical curative effect. The traditional Chinese medicine composition can be further developed into medical institution preparations, is convenient for clinical application, and has positive clinical significance.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine extraction, and particularly relates to a pharmaceutical composition for treating functional dyspepsia, a preparation and a preparation method thereof.
Background
Functional Dyspepsia (FD) is one of the common functional gastrointestinal diseases in gastroenterology. According to the Roman III diagnosis standard, the symptom occurrence region is upper abdomen, and the main symptoms comprise abdominal pain, abdominal burning sensation, abdominal distension, early satiety and the like, and the symptoms occur intermittently at least 1 time per week. The prevalence rate of FD reported in various countries ranges from 19% to 41%, and patients mainly suffering from dyspepsia account for about 52.85% of the outpatient service of the department of gastroenterology. The quality of life of FD patients is significantly reduced and a large number of medical resources are consumed. In recent years, with the development of society, the pace of life of people is accelerated, the working pressure is increased, the dietary structure is changed, and the incidence of FD is in a further rising trend in China.
The western medicine treatment of the disease mainly comprises the following aspects: (1) promoting gastrointestinal motility: the medicine mainly comprises dopamine receptor antagonist, 5-HT4 receptor agonist, motilin receptor agonist and the like; (2) acid inhibition: the therapeutic drugs mainly comprise H2 receptor antagonist (H2RA) and Proton Pump Inhibitor (PPI); (3) anxiolytic depression: more selected are highly selective intracerebral 5-HT reuptake inhibitors; (4) eliminating helicobacter pylori. At present, western medicines are used for treating main clinical symptoms and possible pathological mechanisms of patients, the clinical effect is far from satisfactory, and the western medicines have the defects of easy relapse after stopping taking the medicines, large side effect, high cost and the like.
FD has no specific diagnosis record in traditional Chinese medicine, nearly hundreds of traditional Chinese medicine digestive pathology experts from all over the country are fully discussed and modified under the division organization of the traditional Chinese medicine society for spleen and stomach diseases in 2009, and FD is divided into 5 syndromes, namely spleen deficiency and qi stagnation syndrome, liver and stomach disharmony syndrome, spleen and stomach damp-heat syndrome, spleen and stomach deficiency-cold syndrome and cold-heat mixed syndrome, through the consensus opinion of traditional Chinese medicine diagnosis and treatment of dyspepsia in an unrecognized voting form.
FD is the dominant disease species for traditional Chinese medicine treatment. Systemic evaluation of FD in traditional Chinese medicine treatment has been carried out, and the results show that: compared with western medicines or placebo, the traditional Chinese medicine intervention has obvious advantages in the aspects of improving the cure rate and the total effective rate of the total symptoms; ② the intervention of the traditional Chinese medicine can obviously reduce the FD recurrence rate, and is superior to western medicine or placebo. However, the traditional Chinese medicine research of FD still has some problems: the research method is scientific, lacks of prospective clinical research of random, contrast, double-blind, multi-center and large samples, has lower evidence grade of evidence-based medicine, poor curative effect repeatability and is not easy to be generally accepted; ② the medicine has large difference, the proposal is not standard, mainly soothing liver and regulating qi, strengthening spleen and warming yang, and removing food retention and removing stagnation. Aiming at the main pathogenesis, the treatment method which also gives consideration to the functions of strengthening the spleen and regulating the flow of qi is less. Limits the popularization and application of the traditional Chinese medicine in the treatment of FD.
Disclosure of Invention
Aiming at the problems, the invention provides a pharmaceutical composition for treating functional dyspepsia, a preparation and a preparation method thereof, the preparation method can effectively extract active ingredients in medicinal materials, the traditional Chinese medicine composition prepared by the method has the effects of strengthening spleen, regulating qi, relieving flatulence, harmonizing stomach, lowering adverse qi and relieving pain, and has good clinical effect on treating functional dyspepsia caused by spleen deficiency and qi stagnation.
Specifically, the invention provides the following technical scheme:
a traditional Chinese medicine composition for treating functional dyspepsia is characterized in that: the traditional Chinese medicine composition comprises the following components in parts by weight: 225-750 parts of codonopsis pilosula, 75-500 parts of cortex magnoliae officinalis, 150-375 parts of bran-fried bighead atractylodes rhizome, 225-375 parts of dalbergia wood, 15-250 parts of rhizoma pinellinae praeparata, 45-200 parts of fructus amomi, 75-500 parts of vinegar rhizoma corydalis and 225-375 parts of fried hawthorn.
Preferably, the traditional Chinese medicine composition comprises the following components in proportion: 250-500 parts of codonopsis pilosula, 250-500 parts of cortex magnoliae officinalis, 225-375 parts of bran-fried bighead atractylodes rhizome, 225-375 parts of dalbergia wood, 15-250 parts of rhizoma pinellinae praeparata, 45-200 parts of fructus amomi, 250-500 parts of vinegar rhizoma corydalis and 225-375 parts of fried hawthorn.
Preferably, the traditional Chinese medicine composition comprises the following components in proportion: 375 parts of codonopsis pilosula, 375 parts of cortex magnoliae officinalis, 250 parts of rhizoma atractylodis macrocephalae stir-fried with bran, 250 parts of dalbergia wood, 225 parts of rhizoma pinellinae praeparata, 150 parts of fructus amomi, 375 parts of rhizoma corydalis processed with vinegar and 250 parts of fried hawthorn.
A preparation method of a traditional Chinese medicine composition for treating functional dyspepsia comprises the following steps:
(1) extracting cortex Magnolia officinalis, Atractylodis rhizoma parched with bran, lignum Dalbergiae Odoriferae and fructus Amomi by steam distillation, collecting volatile oil, mixing with first adjuvant, and making into clathrate;
(2) extracting rhizoma corydalis and parched fructus crataegi with ethanol, and filtering to obtain filtrate;
(3) decocting radix Codonopsis and rhizoma Pinelliae Preparata in water, and filtering to obtain filtrate; and
(4) and (3) mixing the filtrate obtained in the step (2) and the filtrate obtained in the step (3), concentrating and drying, and uniformly mixing with the inclusion compound obtained in the step (1) and a second auxiliary material to prepare a finished product preparation.
Preferably, in the step (1), the magnolia officinalis processed with ginger, the white atractylodes rhizome processed with bran, the dalbergia wood and the amomum villosum are added with 8 times of water and are subjected to steam distillation extraction for 8 hours, and the volatile oil is collected.
Preferably, in the step (1), the inclusion compound is prepared by uniformly mixing the volatile oil, the first auxiliary material and water, refrigerating, filtering and drying.
Preferably, in the step (1), the mass ratio of the volatile oil, the first auxiliary material and the water is as follows: 1:8:15.
Preferably, in the step (1), the first auxiliary material is beta-cyclodextrin.
Preferably, in step (1), the temperature for preparing the inclusion compound is 60 ℃.
Preferably, in the step (1), the residue obtained after the extraction by the steam distillation method is decocted with water and filtered, and the filtrate is ready for use.
Further preferably, in the step (1), the decoction conditions of the residue are as follows: adding 8 times of water; decocting for 1 hr.
Preferably, in the step (2), 8 times of ethanol is added.
Preferably, in step (2), ethanol is added for extraction 3 times, each for 1 hour.
Preferably, in step (2), the concentration of ethanol is 70%.
Preferably, in the step (2), the temperature of the ethanol extraction is 55-75 ℃.
Preferably, in the step (3), the codonopsis pilosula and the rhizoma pinellinae praeparata are decocted in water on the dregs obtained in the step (2), and the decoction is filtered to obtain filtrate for later use; and/or in the step (3), decocting for 2 times, and each time lasts for 1 hour.
Further preferably, in the step (3), 8 times of water is added for the first time, and 6 times of water is added for the second time.
Preferably, the mixing in the step (4) is carried out by mixing the filtrate obtained in the step (2) and the filtrate obtained in the step (3) with the distilled aqueous solution obtained in the step (1) and/or the residue obtained by the steam distillation extraction in the step (1);
and/or in the step (4), the second auxiliary material is dextrin.
Preferably, in the step (4), the finished preparation is a decoction, a capsule, a pill, a granule, a tablet or an oral liquid; granules are preferred.
Preferably, the Chinese medicinal composition is applied to preparing medicaments for treating gastrointestinal dyskinesia, abnormal gastric acid secretion or analgesia.
The invention has the advantages of
The traditional Chinese medicine composition has the functions of strengthening spleen, regulating qi, relieving flatulence, harmonizing stomach, lowering adverse qi and relieving pain. Can effectively regulate gastrointestinal dyskinesia, abnormal gastric acid secretion and relieve pain, and has good clinical curative effect on symptoms of epigastric fullness, fullness or pain, anorexia, belch, gastric upset, fatigue, weakness, epigastric ardor and the like caused by spleen deficiency and qi stagnation and FD patients with the symptoms. In addition, compared with western medicines, the traditional Chinese medicine composition for treating functional dyspepsia has low cost, is safe to use, and has no pain and toxic or side effect. The preparation obtained by the preparation method can be further developed into a preparation for medical institutions, is convenient for clinical application, and has positive clinical significance.
Detailed Description
The inventor of the invention focuses on the research of functional dyspepsia diseases for a long time, and discloses a brief preparation process of spleen-invigorating and qi-regulating granules on the basis of the clinical application of the spleen-invigorating and qi-regulating granules in treating functional dyspepsia and the research of pharmacodynamics mechanism in the Wuzhengyu doctor graduation paper in 2016: extracting volatile medicinal components from cortex Magnolia officinalis, Atractylodis rhizoma parched with bran, lignum Dalbergiae Odoriferae, and fructus Amomi by steam distillation, and collecting volatile oil; the main components of the vinegar rhizoma corydalis and the fried hawthorn are respectively alkaloids and organic acids, and the solubility in ethanol is higher, so that the effective components are extracted by heating 70% ethanol; extracting effective components of radix Codonopsis and rhizoma Pinelliae Preparata by decocting; finally, the granules are prepared by forming and drying.
Although the doctor paper discloses eight traditional Chinese medicine components, specific proportions of the components are not disclosed, and if the eight traditional Chinese medicines are not matched in dosage, functional dyspepsia cannot be treated, but negative effects are possibly caused; in addition, the inventor also optimizes the parameters of the preparation process of the traditional Chinese medicine composition, and the obtained traditional Chinese medicine composition has better effect.
One embodiment of the invention provides a traditional Chinese medicine composition for treating functional dyspepsia, which comprises the following components in parts by weight: 225-750 parts of codonopsis pilosula, 75-500 parts of cortex magnoliae officinalis, 150-375 parts of bran-fried bighead atractylodes rhizome, 225-375 parts of dalbergia wood, 15-250 parts of rhizoma pinellinae praeparata, 45-200 parts of fructus amomi, 75-500 parts of vinegar rhizoma corydalis and 225-375 parts of fried hawthorn.
The quality standards of the eight traditional Chinese medicines of codonopsis pilosula, cortex magnoliae officinalis, rhizoma atractylodis macrocephalae stir-fried with bran, dalbergia wood, rhizoma pinellinae praeparata, fructus amomi, rhizoma corydalis stir-fried with vinegar and fructus crataegi used in the invention all meet the relevant regulations under the relevant item of the first edition of the 'Chinese pharmacopoeia' 2015 edition.
Processing method of stir-fried rhizoma Atractylodis Macrocephalae with bran (the edition of 2015 in Chinese pharmacopoeia): spreading the honey-fried bran into a hot pot, adding Atractylodis rhizoma tablet when smoking, parching to brown, discharging burnt smell, taking out, and sieving to remove the honey-fried bran. Every 100kg of the white atractylodes rhizome tablets are roasted by 10kg of bran with honey.
Processing method of rhizoma Pinelliae Preparata (the 2015 edition of Chinese pharmacopoeia): separating rhizoma Pinelliae into different sizes, soaking in water until there is no dry core, and taking out. Decocting Glycyrrhrizae radix in water twice, mixing decoctions, adding into lime solution prepared from appropriate amount of water, stirring, adding the soaked rhizoma Pinelliae, soaking, stirring for 1-2 times every day, keeping pH of the soaking solution above 12, taking out until the section is yellow and uniform, cleaning, and drying in the shade or oven drying. Each 100kg of purified pinellia tuber is prepared from 15kg of liquorice and 10kg of quicklime.
Processing method of vinegar rhizoma corydalis (Chinese pharmacopoeia 2015 edition): parching rhizoma corydalis with vinegar (0213) or decocting with vinegar (0213) until vinegar is absorbed completely, and slicing or mashing.
A processing method of parched fructus crataegi (2015 edition of Chinese pharmacopoeia): parching fructus crataegi with clear parching method (general rule 0213) until color becomes dark.
The eight traditional Chinese medicine components used in the invention are as follows: dangshen, officinal magnolia bark, bran-fried largehead atractylodes rhizome, rosewood heart wood, rhizoma pinellinae praeparata, villous amomum fruit, vinegar-processed corydalis tuber and fried hawthorn fruit, except for adopting a preparation method in the 2015 edition of Chinese pharmacopoeia, the traditional Chinese medicine components obtained by other conventional preparation methods adopted by the technical personnel in the field can also be used in the invention.
The eight traditional Chinese medicines used in the invention have the following functions:
the codonopsis pilosula, the ginger and the magnolia bark are monarch: codonopsis pilosula is sweet and neutral, and enters spleen and lung meridians. It is similar to ren Shen but milder in action of tonifying qi of spleen and lung. The herbal supplement: to tonify middle-jiao and Qi, harmonize spleen and stomach, and relieve polydipsia. The middle-jiao qi is slightly deficient to regulate and tonify, even safe. ". The book of materia Medica: it is not far from ren Shen, because it can tonify spleen and stomach, moisten lung and promote fluid production, and strengthen qi of middle energizer. "; hou Po is bitter and pungent, warm in nature, and enters spleen, stomach, lung and large intestine meridians. It is indicated for damp obstruction of middle energizer, abdominal distention, food retention and qi stagnation because it can descend qi and remove fullness, and is good at drying dampness. The miscellaneous records of famous physicians: the recipe mainly warms the middle warmer, supplements qi, eliminates phlegm and descending qi, and relieves dysphoria, so as to thicken intestines and stomach. The effect of warming stomach, eliminating phlegm and stopping vomiting can be enhanced after the magnolia officinalis is roasted with ginger. The codonopsis pilosula, the ginger and the magnolia bark are monarch drugs, so that the effects of tonifying qi and descending qi are achieved, and the effects of tonifying spleen, regulating qi, relieving flatulence and regulating qi activity of middle-jiao are achieved. The former tonifies the middle-jiao and strengthens the spleen, while the latter eliminates dampness and helps transportation, while the latter helps transportation, and the two complement each other to benefit the effects of strengthening the spleen and assisting transportation.
White atractylodes rhizome stir-fried with bran and dalbergia wood are used as ministers: bai Zhu is sweet, bitter and warm, and enters spleen and stomach meridians. Has effects in invigorating spleen, invigorating qi, and eliminating dampness. Bighead atractylodes rhizome, rhizoma Atractylodis Macrocephalae, which has the effects of removing dampness without impairing qi, entering spleen soil, tonifying spleen qi and assisting spleen transportation, is praised as the first important herb for spleen qi and spleen invigorating by predecessors. In Ben Cao Tong Xuan (the introduction to the xuan of materia Medica), the herbs for tonifying spleen and stomach are not suitable for the right. The actions of strengthening spleen and replenishing qi are enhanced after stir-frying with bran. Jiangxiang, pungent and warm flavor entering liver and spleen meridians. Has effects of removing blood stasis, regulating qi-flowing, and relieving pain. The compendium of materia Medica states that the medicine treats the incised wound and incised wound, stops bleeding and relieves pain, and eliminates swelling and promotes tissue regeneration. "; the original menstrual period was: "Jiangzhenxiang is reddish in color and descends due to blood system invasion, so it can remove blood stasis … … when taken orally. The atractylodes macrocephala koidz and the dalbergia wood are used as ministerial drugs, the effect of supplementing one to achieve the effect of treating the stagnation of qi and the blood is achieved, the effect of supplementing the qi and the middle-jiao and promoting the circulation of qi and regulating the blood are achieved, and the effect of the monarch drugs is combined. Wherein the bighead atractylodes rhizome assists the codonopsis pilosula to strengthen the spleen and replenish qi, the rosewood heart wood assists the magnolia officinalis to regulate qi and eliminate fullness, monarch and minister cooperate with each other, and the functions of strengthening the spleen and regulating qi are complemented.
The rhizoma pinellinae praeparata, the vinegar rhizoma corydalis and the like are used as adjuvant drugs: fa ban Xia is pungent and warm, and enters spleen, stomach and lung meridians. It has effects in eliminating dampness, relieving oppression and masses, and dispersing pathogen accumulation. "digestion of heart, abdomen, chest and diaphragm with phlegm-heat and accumulation, cough, epigastric distention, pain in the lower abdomen, fullness and distention, vomiting and regurgitation … …"; in the medical inspiration, … … harmonizes stomach qi, removes stomach cold, enters … … diet; the main treatment secret essentials indicate that … … is used for drying stomach dampness, resolving phlegm and tonifying spleen and stomach qi. The medicine has the effects of regulating stomach and lowering adverse qi; corydalis tuber is pungent, bitter and warm, and enters heart, liver and spleen meridians. Has effects in promoting blood circulation, promoting circulation of qi, and relieving pain. Ben Cao gang mu, Yan Hu is a miraculous one specially for treating pain of the upper and lower parts of the body because it can promote qi stagnation in blood and blood stagnation in qi. Yanhusuo, Gao, can activate blood and regulate qi, the first herb. After stir-baked with vinegar, it enters liver meridian; the rhizoma pinellinae praeparata, the vinegar rhizoma corydalis and other medicines are used together as an assistant and a guide, and aim at assisting monarch and minister medicines, strengthening the spleen and harmonizing the stomach, regulating the flow of qi and lowering the adverse qi, and activating the blood to build the effect of relieving pain.
Sha ren is pungent and warm in property, and has the actions of resolving dampness, moving qi, warming middle energizer and checking diarrhea. It is pungent, dispersing and warm in property, fragrant in smell, and has good effects of resolving dampness, activating spleen, promoting qi and warming middle energizer, so it is recorded by ancient people: "is the key herb for activating spleen and regulating stomach. "
The stir-fried hawthorn is sour, sweet and slightly warm, and has the effects of promoting digestion, relieving stasis, promoting qi circulation, removing blood stasis and relieving pain. Daily herbal medicine: to resolve food stagnation, remove stagnation of qi, invigorate spleen and relieve diaphragm, and remove blood stasis and qi stagnation. "; compendium of materia Medica: "Hua Yin Shi, Xiao Rou Jie, Mass, phlegm-fluid retention, stuffiness and fullness, acid regurgitation, blood stagnation and distending pain". ".
Therefore, the traditional Chinese medicine composition combines monarch, minister and assistant and guide medicines, has the functions of tonifying and eliminating, has the functions of ascending and descending, can strengthen and transport spleen and stomach, can regulate qi-flowing mechanism, can tonify deficiency and stagnation, and has the effects of tonifying spleen, regulating qi, relieving flatulence, harmonizing stomach, lowering adverse qi and relieving pain.
In order to obtain the traditional Chinese medicine composition, the invention provides a preparation method of a traditional Chinese medicine composition for treating functional dyspepsia, which comprises the following steps:
(1) extracting cortex Magnolia officinalis, Atractylodis rhizoma parched with bran, lignum Dalbergiae Odoriferae and fructus Amomi by steam distillation, collecting volatile oil, mixing with first adjuvant, and making into clathrate;
(2) extracting rhizoma corydalis and parched fructus crataegi with ethanol, and filtering to obtain filtrate;
(3) decocting radix Codonopsis and rhizoma Pinelliae Preparata in water, and filtering to obtain filtrate; and
(4) and (3) mixing the filtrate obtained in the step (2) and the filtrate obtained in the step (3), concentrating and drying, and uniformly mixing with the inclusion compound obtained in the step (1) and a second auxiliary material to prepare a finished product preparation.
In a specific embodiment, the preparation method of the traditional Chinese medicine composition comprises the following steps:
a preparation method of a traditional Chinese medicine composition for treating functional dyspepsia comprises the following steps:
(1) extracting cortex Magnolia officinalis, Atractylodis rhizoma parched with bran, lignum Dalbergiae Odoriferae and fructus Amomi by steam distillation, collecting volatile oil, mixing with first adjuvant, and making into clathrate; collecting the distilled water solution for later use; decocting the residue with water, and filtering to obtain filtrate;
(2) extracting rhizoma corydalis and parched fructus crataegi with ethanol, and filtering to obtain filtrate;
(3) decocting the medicine residues obtained in the step (2), codonopsis pilosula and rhizoma pinellinae praeparata in water, and filtering to obtain filtrate for later use;
(4) and (3) mixing the filtrate obtained in the step (2), the filtrate obtained in the step (3) and the distilled water solution obtained in the step (1) and the filtrate obtained after the residues are decocted by adding water, concentrating, drying and crushing, mixing with the inclusion compound and the second auxiliary material in the step (1), and further preparing the finished product preparation.
The Chinese medicinal composition of the present invention is explained in detail by specific examples below.
Example 1
TABLE 1 formulation ratio of the Chinese medicinal materials used in example 1
| Chinese medicine | Content (wt.) | Chinese medicine | Content (wt.) | Chinese medicine | Content (wt.) | Chinese medicine | Content (wt.) |
| Codonopsis pilosula | 375 portions of | Cortex Magnolia officinalis | 375 portions of | Bran-fried bighead atractylodes rhizome | 250 portions of | Lignum Dalbergiae Odoriferae | 250 portions of |
| Rhizoma Pinelliae Preparata | 225 parts by weight | Fructus amomi | 150 portions of | Vinegar corydalis tuber | 375 portions of | Fried hawthorn | 250 portions of |
A preparation method of a traditional Chinese medicine composition for treating functional dyspepsia comprises the following steps:
(1) taking cortex magnoliae officinalis, bran-fried rhizoma atractylodis macrocephalae, lignum dalbergiae odoriferae and fructus amomi, adding 8 times of water, extracting volatile oil for 8 hours by using a steam distillation method, collecting the volatile oil, weighing beta-cyclodextrin with 8 times of volatile oil amount and water with 15 times of volatile oil amount to prepare a 60 ℃ aqueous solution, adding the volatile oil while stirring, continuously stirring for 3 hours at the temperature of 60 ℃, refrigerating for 24 hours, performing suction filtration, and drying at 40 ℃ for later use; collecting the distilled water solution in another container for later use; decocting the residue with 8 times of water for 1 hr, filtering, and collecting filtrate.
(2) Heating and extracting rhizoma corydalis processed with vinegar and fructus crataegi preparata with 8 times of 70% ethanol at 55-75 deg.C for 3 times, each for 1 hr, and filtering to obtain filtrate;
(3) decocting the residue obtained by filtering in the step (2) with radix Codonopsis and rhizoma Pinelliae Preparata for 2 times, 1 hr each time, adding 8 times of water for the first time and 6 times of water for the second time, and filtering to obtain filtrate.
(4) Mixing the filtrate obtained in the step (2), the filtrate obtained in the step (3), the distilled water solution obtained in the step (1) and the filtrate obtained by decocting residues in water, concentrating to obtain a clear paste with the relative density of 1.30-1.35 (50 ℃), drying under reduced pressure, crushing, mixing with the beta-cyclodextrin inclusion compound and the dextrin, uniformly mixing, granulating with ethanol, and drying to obtain the granular preparation.
Example 2
TABLE 2 proportioning of the Chinese medicinal materials used in example 2
| Chinese medicine | Content (wt.) | Chinese medicine | Content (wt.) | Chinese medicine | Content (wt.) | Chinese medicine | Content (wt.) |
| Codonopsis pilosula | 225 parts by weight | Cortex Magnolia officinalis | 75 portions of | Bran-fried bighead atractylodes rhizome | 150 portions of | Lignum Dalbergiae Odoriferae | 225 parts by weight |
| Rhizoma Pinelliae Preparata | 75 portions of | Fructus amomi | 75 portions of | Vinegar corydalis tuber | 75 portions of | Fried hawthorn | 225 parts by weight |
The procedure for preparing the Chinese medicinal granule from the Chinese medicinal components is the same as in example 1.
Example 3
TABLE 3 proportioning of the Chinese medicinal materials used in example 3
| Chinese medicine | Content (wt.) | Chinese medicine | Content (wt.) | Chinese medicine | Content (wt.) | Chinese medicine | Content (wt.) |
| Codonopsis pilosula | 750 portions of | Cortex Magnolia officinalis | 250 portions of | Bran-fried bighead atractylodes rhizome | 300 portions of | Lignum Dalbergiae Odoriferae | 375 portions of |
| Rhizoma Pinelliae Preparata | 225 parts by weight | Fructus amomi | 150 portions of | Vinegar corydalis tuber | 250 portions of | Fried hawthorn | 300 portions of |
The procedure for preparing the Chinese medicinal granule from the Chinese medicinal components is the same as in example 1.
The following is a description of the relevant tests using the Chinese medicinal granule preparation obtained in example 1 of the present invention.
Test 1 Effect on gastrointestinal motility of atropine-induced gastrointestinal motility disorder rats
1. Experimental Material
1.1 test drugs
The granular formulation prepared in example 1; xiangshaliujun pills, lot number: 4082304, manufacturer: beijing Tongrentang pharmaceuticals, Inc.; morpholine, batch number: 150331894, manufacturer: saian Ponsen pharmaceuticals, Inc.
1.2 Experimental animals
SD rat, Beijing Wittiulihua laboratory animal technology Co., Ltd;
1.3 reagents
Atropine sulfate, provided by Tianjin Jinyao pharmaceutical Co., Ltd;
2. experimental methods
The SD rats were randomly divided into a normal group, a model group, a high dose group of example 1, a medium dose group of example 1, a low dose group of example 1, a xiangshaliujunwan group, and a morpholine group, and 12 rats were administered to each group.
Example 1 the high dose group was administered to the granular formulation obtained in example 1 (18.9g crude drug/kg), the dose group in example 1 was administered to the granular formulation obtained in example 1 (9.45g crude drug/kg), the low dose group in example 1 was administered to the granular formulation obtained in example 1 (4.72g crude drug/kg), the xiangshaliujun pill group was administered to the xiangshaliujun pill (1.89g finished drug/kg), the molsidine group was administered to the molsidine (0.00315g finished drug/kg), the normal group and the model group were administered with equal volumes of physiological saline, and the administration was performed once daily for 5 days. Except for the normal group, the rats were injected with atropine sulfate (2mg/kg) intraperitoneally 20min before the test, and after 20min, 2 ml/rat of the semi-solid nutritional paste was administered. After 20 minutes, the cervical vertebrae are removed to kill the rat, the abdomen is opened to ligate the cardia and the pylorus, the stomach is taken out, the stomach is wiped dry by using filter paper and then the full weight of the stomach is weighed, then the stomach body is cut along the greater curvature of the stomach, the gastric contents are washed off, the stomach body is wiped dry by using the filter paper and the net weight of the stomach is weighed, and the residual rate of the stomach is calculated. And simultaneously, quickly taking out the small intestine, slightly stripping the small intestine, then directly paving the small intestine on white paper, measuring the distance from the pylorus to the full length of the ileocecal part and the distance from the pylorus to the front edge of the black semisolid nutrient paste, and taking the percentage of the distance from the pylorus to the front edge of the black semisolid nutrient paste to the full length of the pylorus to the ileocecal part as the small intestine propulsion rate.
The gastric residual rate (%) [ (total weight of stomach-net weight)/weight of semisolid paste ] × 100%
The small intestine propulsion rate (%) -. semisolid paste length/small intestine full length × 100%
3. Results of the experiment
TABLE 4 variation of gastric residual rate and intestinal transit rate in various groups of rats
Note: p <0.05, P <0.01, relative to normal group; p <0.05, P <0.01, relative to the model group.
The results show that the gastric residual rate of the model group rats is obviously increased (P <0.01) and the small intestine propulsion rate is obviously reduced (P <0.01) compared with the normal group rats. Compared with the model group rats, the gastric residual rate and the small intestine propulsion rate of the rats in each dose group show different degrees of improvement. The high dose, the medium dose and the low dose of the granular preparation obtained in example 1 can effectively reduce the gastric residual rate (P <0.01, P <0.05, P <0.05) and increase the small intestine propulsion rate (P <0.01, P <0.01, P <0.01) of rats with gastrointestinal motility disorders. The results show that the granular preparation obtained by the invention can obviously improve the gastric residual rate and the small intestine propulsion rate of a rat model, and the curative effects of the gastric residual rate and the small intestine propulsion rate are equivalent to those of the Xiangshaliujun pill group and the morpholine group.
Experiment 2 Effect on atropine-induced gastrointestinal motility weakening mouse model Small intestine Propulsion Rate
1. Experimental Material
1.1 test drugs
The granular formulation prepared in example 1; xiangshaliujun pills, lot number: 4082304, manufacturer: beijing Tongrentang pharmaceuticals, Inc.; morpholine, lot No. 150331894, manufacturer: saian Ponsen pharmaceuticals, Inc.
1.2 Experimental animals
ICR mouse, weight 18-22g, by Beijing vitamin Tonglihua experimental animal technology company Limited;
1.3 reagents
Atropine sulfate, provided by Tianjin Jinyao pharmaceutical Co., Ltd;
2. experimental methods
The ICR mice were randomly divided into a normal group, a model group, a high dose group of example 1, a medium dose group of example 1, a low dose group of example 1, a satsuma pill group, and a morpholine group, and 20 mice were administered to each group.
Example 1 the granule formulation obtained in example 1 (27.27g crude drug/kg) was administered to the high dose group, the granule formulation obtained in example 1 (13.64g crude drug/kg) was administered to the dose group in example 1, the granule formulation obtained in example 1 (6.82g crude drug/kg) was administered to the low dose group in example 1, the xiangshaliujun pill group was administered to the xiangshaliujun pill (2.7g finished drug/kg), the molsidine group was administered to the molsidine (0.0045g finished drug/kg), and the normal group and the model group were administered with an equal volume of physiological saline, and were drenched once a day for 5 days. Except for the normal group, the mice were injected with atropine sulfate (10mg/kg) intraperitoneally 20min before the test.
The small intestine propulsion rate (%) -. semisolid paste length/small intestine full length × 100%
3. Results of the experiment
TABLE 5 Change in intestinal motility in groups of mice
Note: p <0.05, P <0.01, relative to normal group; p <0.05, P <0.01, relative to the model group.
The results show that the intestinal propulsion rate of the model group mice is obviously reduced compared with that of the normal group (P < 0.01); high-dose and medium-dose interventions can effectively increase the small intestine propulsion rate and have statistical significance (P <0.01, P <0.05) compared with the model group, while low-dose interventions do not significantly increase the small intestine propulsion rate. The result shows that the granular preparation obtained by the invention can obviously improve the small intestine propulsion rate of a mouse model, and the curative effect on the small intestine propulsion rate is equivalent to that of the morpholine group or the xiangshaliujun pill group.
Experiment 3 Effect on the rate of intestinal propulsion in mouse model of gastrointestinal hypermotility caused by neostigmine
1. Experimental Material
1.1 test drugs
The granular formulation prepared in example 1; xiangshaliujun pills, lot number: 4082304, manufacturer: beijing Tongrentang pharmaceuticals, Inc.; atropine, lot No. 1411131, manufacturer: tianjin Jinyao pharmaceutical Co., Ltd;
1.2 Experimental animals
The ICR mouse is 18-22g in weight and is provided by Beijing Wittiulihua experimental animal technology limited company;
1.3 reagents
Neostigmine methosulfate, offered by Shanghai Xinyi Jinzhu pharmaceutical Co., Ltd;
2. experimental methods
The ICR mice were randomly divided into a normal group, a model group, a high dose group in example 1, a medium dose group in example 1, a low dose group in example 1, a six jun pill group of xiangsha, and an atropine group, each of which was 20 mice.
Example 1 the high dose group was administered to the granular formulation obtained in example 1 (27.27g crude drug/kg), the dose group in example 1 was administered to the granular formulation obtained in example 1 (13.64g crude drug/kg), the low dose group in example 1 was administered to the granular formulation obtained in example 1 (6.82g crude drug/kg), the sandrine pill group was administered to the sandrine pill (2.7g finished drug/kg), the atropine group was administered to atropine (0.0005g finished drug/kg), and the normal group and the model group were administered with equal volumes of physiological saline, and were drenched once a day for 5 days. Except for the normal group, mice were injected with neostigmine mesylate (0.1mg/kg) intraperitoneally 20min before the test.
The small intestine propulsion rate (%) -. semisolid paste length/small intestine full length × 100%
3. Results of the experiment
TABLE 6 Change in intestinal motility in groups of mice
Note: p <0.05, P <0.01, relative to normal group; p <0.05, P <0.01, relative to the model group.
The results show that the intestinal propulsion rate of the model group mice is obviously increased compared with that of the normal group (P < 0.01); high, medium, and low dose intervention was effective in reducing the rate of small bowel propulsion in mice and was statistically significant compared to the model group (P <0.01, P < 0.05). Wherein the high dose group, the medium dose group are more effective than the low dose group. The results show that the traditional Chinese medicine composition can obviously improve the small intestine propulsion rate of a mice model with hyperfunction of gastrointestinal motility, and the curative effect on the small intestine propulsion rate is equivalent to that of an atropine group or a xiangshaliujun pill group.
Test 4 Effect on the amount of food intake, gastric secretion and gastrointestinal hormones in rats with functional dyspepsia
1. Experimental Material
1.1 test drugs:
the granular formulation prepared in example 1; xiangshaliujun pills, lot number: 4082304, manufacturer: beijing Tongrentang pharmaceuticals, Inc.; morpholine, lot No. 150331894, manufacturer: west amoeb pharmaceutical co; dachengqi decoction (decoction of rhubarb 10g, immature bitter orange 10g, mirabilite 10g and magnolia bark 10g, 200 ml).
1.2 Experimental animals:
SD rats weighing 190-210 g are provided by Beijing Wittiulihua laboratory animal technology Co.
2. Experimental methods
The SD rats were randomly divided into a normal group, a model group, a high dose group in example 1, a medium dose group in example 1, a low dose group in example 1, a xiangshaliujunwan group, and a morpholine group, and 10 rats were each group.
The molding method comprises the following steps: adopting combined molding: and (3) performing combined modeling by major qi-bearing soup drenching, irregular diet and tail clamping stress method, and establishing an FD rat model. Except for the normal group of rats, the other groups of rats adopt combined modeling: firstly, 1.5ml/100g of Dachengqi decoction (1g/ml) is infused every day; ② fasting without water supply every other day; and clamp tail stress stimulation. The whole molding process lasts for 10 days. After the molding is finished, 18.9g of crude drug/kg.d is administered to the granular preparation in example 1 in the high dose group, 9.45g of crude drug/kg.d is administered to the granular preparation in example 1 in the dose group in example 1, 4.72g of crude drug/kg.d is administered to the granular preparation in example 1 in the low dose group, 1.89g of patent drug/kg.d is administered to the Xiangshaliujun pill group, 0.00315g of molitriline is administered to the molsidrine group in the normal and model groups, and the normal and model groups are administered with physiological saline with equal volume for 21 days.
The influence of the granular preparation of example 1 on gastric acid and pepsin levels of FD rats after intragastric administration for 21 days was examined by alkali titration and modified ANSON (ANSON) method, respectively.
The effect of intragastric administration of the granular formulation of example 1 on serum oxyntomodulin levels in FD rats for 21 days was examined by ELISA.
3. Results of the experiment
TABLE 7 variation of food intake of rats in each group
Note: p <0.05, P <0.01, relative to normal group; p <0.05, P <0.01, relative to the model group.
The results show that the 3h food intake of the rats in the model group is obviously reduced compared with that in the normal group (P <0.01), and the food intake can be effectively increased by high-dose, medium-dose and low-dose interventions (P <0.05, P <0.01 and P <0.05), wherein the 3h food intake of the rats in the medium-dose group is obviously increased.
TABLE 8 Effect of gastric fluid volume, gastric acid and pepsin activity in groups of rats
The results show that high, medium and low dose intervention has no effect on gastric acid and pepsin activity in rats (P > 0.05).
TABLE 9 comparison of serum oxyntomodulin SS, CCK, VIP and GAS levels in groups of rats
Note: p <0.05, P <0.01, relative to normal group; p <0.05, P <0.01, relative to the model group. SS refers to somatostatin, CCK refers to cholecystokinin (cholecystokinin), VIP refers to Vasoactive Intestinal Peptide (Vasoactive Intestinal Peptide), and GAS refers to gastrin (gastrin).
The result of the gastrointestinal hormone shows that the serum SS, CCK and VIP levels of the model group rats are obviously higher than those of the normal group rats, and the serum GAS level of the model group rats is lower than that of the normal group rats; the high, medium and low dose intervention can effectively reduce the serum SS and CCK levels of rats (SS: P <0.01, P <0.01, P < 0.01; CCK: P <0.01, P <0.01, P <0.05), and the low dose intervention can effectively reduce the serum VIP level of rats (P < 0.05); the medium and low dose group intervention can effectively improve the serum GAS level of rats (P <0.01 ).
In conclusion, the granular preparation obtained by the invention can obviously improve the food intake of a rat model, and the curative effect on the food intake is equivalent to that of a morpholine group or a xiangshaliujun pill group. The traditional Chinese medicine composition can obviously improve the serum SS, CCK and GAS levels of a rat model, and has the same adjusting effect on the serum SS, CCK and GAS levels as the curative effect of a morpholine group or a xiangshaliujun pill group.
Experiment 5 analgesic effect study on acetic acid intraperitoneal injection mouse pain model
1. Experimental Material
1.1 test drugs:
the granular formulation prepared in example 1; xiangshaliujun pills, lot number: 4082304, manufacturer: beijing Tongrentang pharmaceuticals, Inc.; fenbyde, batch number H10900089, manufacturer: zhongmei Tianjin Shike pharmaceutical Co., Ltd.
1.2 Experimental animals:
the ICR mouse is 18-22g in weight and is provided by Beijing Wittiulihua experimental animal technology limited company;
1.3 reagent:
acetic acid solution, provided by Shanghai national drug group chemical reagents, Inc.;
2. experimental methods
The ICR mice were randomly divided into a normal group, a model group, a high dose group in example 1, a medium dose group in example 1, a low dose group in example 1, a xiangshaliujunwan group, and a fenbibide group, with 20 mice per group.
Example 1 the high dose group was administered to the granular formulation obtained in example 1 (27.27g crude drug/kg), the dose group in example 1 was administered to the granular formulation obtained in example 1 (13.64g crude drug/kg), the low dose group in example 1 was administered to the granular formulation obtained in example 1 (6.82g crude drug/kg), the xiangshaliujun pill group was administered to the xiangshaliujun pill (2.7g finished drug/kg), the fenbifen group was administered to the fenbifen (0.09g finished drug/kg), the normal group and the model group were administered with equal volumes of physiological saline, and the administration was performed once daily for 5 days. 1 hour after the last administration, 0.3ml of 0.6% acetic acid solution was administered into the abdominal cavity of the mouse 20min before the test in each group except the normal group, resulting in a pain model in the mouse. The time from the intraperitoneal injection of acetic acid to the first writhing of the mice (writhing latency) and the number of writhing of each group of mice within 20 minutes after the injection of acetic acid were observed and recorded by three subjects out-of-group experimenters.
3. Results of the experiment
TABLE 10 study of analgesic Effect
Note: p <0.05, P <0.01, relative to the model group.
The results show that compared with the model group, the high-dose, medium-dose and fenbib groups can obviously prolong the writhing latency period of the mice (P <0.01, P <0.05 and P <0.01), reduce the writhing frequency of the mice within 20 minutes (P <0.01, P <0.01 and P <0.01) and have no effect in the low-dose group. The granular preparation has obvious analgesic effect on acetic acid abdominal cavity injection mouse pain models, and the analgesic effect is obviously superior to that of the Xiangshaliujun pill group and slightly lower than that of the fenbibide group.
Test 6 clinical verification
The granular preparation in example 1 is used for effect verification, 120 patients with functional dyspepsia of spleen deficiency and qi stagnation syndrome are randomly divided into an experimental group and a control group, each group comprises 60 patients, the experimental group takes the granular preparation in example 1 (namely the ginseng spleen strengthening and qi regulating granules), the control group takes a simulation agent (containing 1/30 dosage of the ginseng spleen strengthening and qi regulating granules, which is prepared and provided by a test base in the institute of clinical pharmacy in Beijing), the treatment course is 4 weeks, the visit is carried out one month after the treatment, and the traditional Chinese medicine syndrome integral (made according to the guidance principle of new traditional Chinese medicine clinical research, the diagnosis and treatment consensus of chronic gastritis experts) is comprehensively evaluated, the traditional Chinese medicine overall curative effect is evaluated, and the single western medicine symptom (single degree score of the main western medicine symptom is multiplied by the single frequency score) is comprehensively evaluated.
TABLE 11 Chinese medicine syndrome integral change chart before and after treatment
TABLE 12 Total therapeutic effect of TCM on 2 weeks of treatment
| Group of | Clinical recovery | Show effect | Is effective | Invalidation | Total effective rate |
| Test group N60 | 8(13.3％) | 11(18.3％) | 30(50％) | 11(18.3％) | 81.7％ |
| Control group N60 | 3(5％) | 6(10％) | 26(43.3％) | 25(41.7％) | 58.3％ |
TABLE 13 Total therapeutic effect of Chinese medicine for 4 weeks
| Group of | Clinical recovery | Show effect | Is effective | Invalidation | Total effective rate |
| Test group N60 | 13(21.7％) | 20(33.3％) | 23(38.3％) | 4(6.7％) | 93.3％ |
| Control group N60 | 6(10.0％) | 14(23.3％) | 21(35.0％) | 19(31.7％) | 68.3％ |
TABLE 14 Total therapeutic effects of Chinese medicine at one month follow-up
| Group of | Clinical recovery | Show effect | Is effective | Invalidation | Total effective rate |
| Test group N60 | 15(25.0％) | 26(43.3％) | 14(23.3％) | 5(8.3％) | 91.7％ |
| Control group N60 | 2(3.3％) | 7(11.7％) | 24(40.0％) | 27(45.0％) | 55.0％ |
TABLE 15 Upper abdominal distention integral table
| Group of | Before treatment | 2 weeks | 4 weeks | Follow-up visit of 1 month |
| Test group N60 | 7,317±5.457 | 1.933±2.939* | 0.733±1.528* | 0.850±1.582* |
| Control group N60 | 8.967±4.654 | 4.300±3.920* | 3.883±3.936* | 4.800±4.003* |
TABLE 16 Upper abdomen pain score-chart
| Group of | Before treatment | 2 weeks | 4 weeks | Follow-up visit of 1 month |
| Test group N60 | 5.517±6.408 | 1.783±3.992* | 0.800±2.106* | 0.583±1.942* |
| Control group N60 | 4.800±5.980 | 1.800±2.996* | 2.100±3.564* | 2.667±3.816* |
TABLE 17 early satiety integral table
| Group of | Before treatment | 2 weeks | 4 weeks | Follow-up visit of 1 month |
| Test group N60 | 6.733±5.275 | 1.717±2.775* | 0.617±1.497* | 0.700±1.566* |
| Control group N60 | 8.100±5.473 | 3.750±3.847* | 3.483±3.942* | 4.517±4.011* |
Watch 18 upper abdomen burning integral meter
| Group of | Before treatment | 2 weeks | 4 weeks | Follow-up visit of 1 month |
| Test group N60 | 2.133±4.869 | 0.467±1.620* | 0.350±1.388* | 0.400±1.639* |
| Control group N60 | 1.867±4.098 | 0.483±1.372* | 0.483±2.038* | 0.500±2.111* |
The results show that the granular preparation has obvious treatment effect on patients with functional dyspepsia, and can obviously improve the symptoms of epigastric fullness, epigastric pain, epigastric burning and early satiety.
In conclusion, the granular preparation has good clinical effect on treating the functional dyspepsia with spleen deficiency and qi stagnation.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (12)
1. A traditional Chinese medicine composition for treating functional dyspepsia is characterized in that: the traditional Chinese medicine composition comprises the following components in parts by weight: 225-750 parts of codonopsis pilosula, 75-500 parts of cortex magnoliae officinalis, 150-375 parts of bran-fried bighead atractylodes rhizome, 225-375 parts of dalbergia wood, 15-250 parts of rhizoma pinellinae praeparata, 45-200 parts of fructus amomi, 75-500 parts of vinegar rhizoma corydalis and 225-375 parts of fried hawthorn.
2. The traditional Chinese medicine composition for treating functional dyspepsia according to claim 1, which is characterized in that: the traditional Chinese medicine composition comprises the following components in parts by weight: 250-500 parts of codonopsis pilosula, 250-500 parts of cortex magnoliae officinalis, 225-375 parts of bran-fried bighead atractylodes rhizome, 225-375 parts of dalbergia wood, 15-250 parts of rhizoma pinellinae praeparata, 45-200 parts of fructus amomi, 250-500 parts of vinegar rhizoma corydalis and 225-375 parts of fried hawthorn.
3. The traditional Chinese medicine composition for treating functional dyspepsia according to claim 1 or 2, which is characterized in that: the traditional Chinese medicine composition comprises the following components in parts by weight: 375 parts of codonopsis pilosula, 375 parts of cortex magnoliae officinalis, 250 parts of rhizoma atractylodis macrocephalae stir-fried with bran, 250 parts of dalbergia wood, 225 parts of rhizoma pinellinae praeparata, 150 parts of fructus amomi, 375 parts of rhizoma corydalis processed with vinegar and 250 parts of hawthorn fruit stir-fried.
4. A method for preparing the traditional Chinese medicine composition for treating functional dyspepsia of any one of claims 1 to 3, which comprises the following steps:
(1) extracting cortex Magnolia officinalis, Atractylodis rhizoma parched with bran, lignum Dalbergiae Odoriferae and fructus Amomi by steam distillation, collecting volatile oil, mixing with first adjuvant, and making into clathrate;
(2) extracting rhizoma corydalis and parched fructus crataegi with ethanol, and filtering to obtain filtrate;
(3) decocting radix Codonopsis and rhizoma Pinelliae Preparata in water, and filtering to obtain filtrate; and
(4) and (3) mixing the filtrate obtained in the step (2) and the filtrate obtained in the step (3), concentrating and drying, and uniformly mixing with the inclusion compound obtained in the step (1) and a second auxiliary material to prepare a finished product preparation.
5. The preparation method of the traditional Chinese medicine composition for treating functional dyspepsia according to claim 4, which is characterized by comprising the following steps: in the step (1), the magnolia officinalis, the white atractylodes rhizome stir-fried with bran, the dalbergia wood and the amomum villosum are taken, 8 times of water is added, the water vapor distillation extraction is carried out for 8 hours, and the volatile oil is collected.
6. The preparation method of the traditional Chinese medicine composition for treating functional dyspepsia according to claim 4 or 5, which is characterized by comprising the following steps: in the step (1), the inclusion compound is prepared by uniformly mixing the volatile oil, the first auxiliary material and water, refrigerating, filtering and drying; preferably, the mass ratio of the volatile oil to the first auxiliary material to the water is as follows: 1:8: 15; the first excipient is preferably beta-cyclodextrin.
7. The preparation method of the traditional Chinese medicine composition for treating functional dyspepsia according to any one of claims 4 to 6, which is characterized by comprising the following steps: in the step (1), adding water into residues obtained after extraction by a steam distillation method for decoction, and filtering to obtain filtrate for later use; preferably, the decoction conditions of the residue are as follows: adding 8 times of water; decocting for 1 hr.
8. The preparation method of the traditional Chinese medicine composition for treating functional dyspepsia according to any one of claims 4 to 7, which is characterized by comprising the following steps: in the step (2), 8 times of ethanol is added for ethanol extraction; the concentration of ethanol is preferably 70%; further preferably, the ethanol is extracted for 3 times, each time for 1 hour; more preferably, the temperature of the ethanol extraction is 55-75 ℃.
9. The preparation method of the traditional Chinese medicine composition for treating functional dyspepsia according to any one of claims 4 to 8, which is characterized by comprising the following steps: in the step (3), the codonopsis pilosula and the rhizoma pinellinae praeparata are added with water to decoct the dregs obtained in the step (2), and then the decoction is filtered to obtain filtrate for later use;
and/or in the step (3), the decoction is carried out for 2 times, and each time lasts for 1 hour; preferably, 8 times the amount of water is added for the first time and 6 times the amount of water is added for the second time.
10. The preparation method of the traditional Chinese medicine composition for treating functional dyspepsia according to any one of claims 4 to 9, which is characterized by comprising the following steps: the mixing in the step (4) is to mix the filtrate obtained in the step (2) and the filtrate obtained in the step (3) with the distilled aqueous solution obtained in the step (1) and/or the residue obtained after the steam distillation extraction in the step (1);
and/or in the step (4), the second auxiliary material is dextrin.
11. The preparation method of the traditional Chinese medicine composition for treating functional dyspepsia according to any one of claims 4 to 10, wherein the preparation method comprises the following steps: the finished product preparation in the step (4) is decoction, capsules, pills, granules, tablets or oral liquid.
12. Use of a Chinese medicinal composition according to any one of claims 1 to 3 or prepared by a process for preparing a Chinese medicinal composition according to any one of claims 4 to 11 in the manufacture of a medicament for the treatment of gastrointestinal dyskinesia, abnormal gastric acid secretion or analgesia.
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