Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating functional dyspepsia

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to application of a traditional Chinese medicine composition in preparation of medicines for preventing and treating functional dyspepsia. The traditional Chinese medicine composition comprises the following components in parts by weight: 1-100 parts of mangnolia officinalis, 1-100 parts of scorched betel nut, 1-100 parts of roasted amomum tsao-ko, 1-100 parts of ephedra, 1-100 parts of semen armeniacae amarae, 1-100 parts of notopterygium root, 1-100 parts of ginger, 1-100 parts of pogostemon cablin, 1-100 parts of eupatorium, 1-100 parts of rhizoma atractylodis, 1-160 parts of poria cocos, 1-120 parts of bighead atractylodes rhizome, 1-100 parts of gypsum, 1-100 parts of scorched hawthorn fruit, 1-100 parts of scorched medicated leaven, 1-100 parts of scorched malt, 1-100 parts of earthworm, 1-100 parts of cynanchum paniculatum, 1-100 parts The traditional Chinese medicine composition can remarkably improve body mass, promote gastric emptying and improve the gastrointestinal hormone level, and has a good treatment effect on functional dyspepsia.

Description

[0001] This application claims the priority of the Chinese patent application filed with the China Patent Office on June 8, 2023, with application number 202310680147.9 and invention name “Application of Chinese herbal composition in the preparation of drugs for preventing and treating functional dyspepsia”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present invention relates to the technical field of traditional Chinese medicines, and in particular to application of a traditional Chinese medicine composition in preparing medicines for preventing and treating functional dyspepsia. Background Art

[0003] Functional dyspepsia (FD) is a common functional gastrointestinal disease, including epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). Its main symptoms include epigastric pain, upper abdominal distension, early satiety, belching, loss of appetite, nausea, vomiting, etc. It is one of the most common functional gastrointestinal diseases in clinical practice. It is related to multiple factors such as gastrointestinal motility disorders, visceral hypersensitivity, Helicobacter pylori infection, etc. Long-term anxiety and depression may increase the risk of disease. The onset is usually slow, persistent or recurrent, and many patients have dietary, mental and other inducing factors. It is often dominated by one or a group of symptoms, and the symptoms may also change during the course of the disease. The main symptoms include postprandial fullness, early satiety, distension and pain in the middle and upper abdomen, burning sensation in the middle and upper abdomen, belching, lack of appetite, nausea, etc. Upper abdominal pain is a common symptom, often related to eating, manifested as postprandial pain, which may also be irregular. Some patients experience a burning sensation in the upper abdomen. Postprandial fullness and early satiety are often closely related to eating. Postprandial fullness refers to a feeling of fullness after a normal meal; early satiety refers to a feeling of hunger but a feeling of fullness soon after eating. Many patients also have mental symptoms such as insomnia, anxiety, depression, headache, and inattention.

[0004] The existing therapeutic drugs are not effective. Therefore, providing a related product developed based on Chinese herbal medicine has important practical significance in the prevention and treatment of functional dyspepsia. Summary of the invention

[0005] In view of this, the present invention provides the use of a Chinese medicine composition in the preparation of a drug for preventing and treating functional dyspepsia. The present invention has found through experiments that the Chinese medicine composition of the present invention is beneficial to weight gain, can significantly promote gastric emptying, improve gastrointestinal hormone levels, and has a good therapeutic effect on functional dyspepsia.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] The present invention provides the use of a Chinese medicine composition in preparing a medicine for treating and / or preventing functional dyspepsia;

[0008] The Chinese medicine composition comprises: 1-100 parts of Magnolia officinalis, 1-100 parts of burnt Areca catechu, 1-100 parts of stewed Tsaoko fruit, 1-100 parts of Ephedra, 1-100 parts of Bitter Apricot, 1-100 parts of Notopterygium wilfordii, 1-100 parts of Ginger, 1-100 parts of Patchouli, 1-100 parts of Cyperus rotundus, 1-100 parts of Atractylodes macrocephala, 1-160 parts of Poria, 1-120 parts of Atractylodes macrocephala, 1-100 parts of Gypsum, 1-100 parts of burnt Crataegus pinnatifida, 1-100 parts of burnt Liu Shenqu, 1-100 parts of burnt malt, 1-100 parts of Pheretima, 1-100 parts of Cynanchum chinense, 1-100 parts of Cyperus rotundus and / or 1-100 parts of Lepidium chinense.

[0009] In some specific embodiments of the present invention, the treatment and / or prevention of functional dyspepsia comprises any of the following:

[0010] (I), improving body mass; and / or

[0011] (II), promoting gastric emptying; and / or

[0012] (III) Improve gastrointestinal hormone levels.

[0013] In some specific embodiments of the present invention, the improving gastrointestinal hormone levels comprises any of the following:

[0014] (I), increase serum motilin level; and / or

[0015] (II), increasing serum gastrin levels; and / or

[0016] (III) Reduce serum vasoactive intestinal peptide levels.

[0017] In some specific embodiments of the present invention, the traditional Chinese medicine composition includes: 10-80 parts of Magnolia officinalis, 10-80 parts of scorched betel nut, 10-80 parts of stewed tsaoko, 10-60 parts of ephedra, 10-60 parts of bitter almond, 10-80 parts of Notopterygium wilfordii, 10-60 parts of ginger, 10-80 parts of patchouli, 10-60 parts of Cyperus rotundus, 10-80 parts of Atractylodes macrocephala, 10-160 parts of Poria cocos, 10-120 parts of Atractylodes macrocephala, 10-80 parts of gypsum, 10-50 parts of scorched hawthorn, 10-80 parts of scorched Liu Shenqu, 10-60 parts of scorched malt, 10-80 parts of earthworm, 10-80 parts of Cynanchum chinense, 10-60 parts of Cyperus rotundus and / or 10-80 parts of Lemongrass seeds, or a combination of two or more thereof.

[0018] In some specific embodiments of the present invention, the Chinese medicine composition comprises: 30-50 parts of Magnolia officinalis, 20-30 parts of charred Areca nut, 30-50 parts of stewed Tsaoko fruit, 20-30 parts of Ephedra, 20-30 parts of Bitter Apricot, 30-50 parts of Notopterygium wilfordii, 30-50 parts of Ginger, 30-50 parts of Patchouli, 20-30 parts of Perilla frutescens, 30-50 parts of Atractylodes, 120-150 parts of Poria, 80-100 parts of Atractylodes macrocephala, 30-50 parts of Gypsum, 20-30 parts of charred Crataegus pinnatifida, 30-50 parts of charred Liu Shenqu, 20-30 parts of charred Malt, 30-50 parts of Pheretima, 30-50 parts of Cynanchum cyrtonema, 20-30 parts of Cynomorium wilfordii and / or 30-50 parts of Lepidium chinense;

[0019] Preferentially, one or a combination of two or more of 50 parts of Magnolia officinalis, 30 parts of scorched Areca nut, 30 parts of stewed Tsaoko fruit, 20 parts of Ephedra, 30 parts of Bitter Apricot, 50 parts of Notopterygium wilfordii, 50 parts of Ginger, 50 parts of Patchouli, 30 parts of Perilla frutescens, 50 parts of Atractylodes macrocephala, 150 parts of Poria, 100 parts of Atractylodes macrocephala, 50 parts of Gypsum, 30 parts of scorched Crataegus pinnatifida, 30 parts of scorched Liu Shenqu, 30 parts of scorched malt, 50 parts of Pheretima, 50 parts of Cynanchum chinense, 30 parts of Cynomorium mongolicum and / or 50 parts of Semen Lepidium.

[0020] In some specific embodiments of the present invention, the Chinese medicine composition includes but is not limited to raw materials, powders, slices or other forms made from raw materials, and extracts, fermentation broths or other forms with the same or similar biological activities.

[0021] In some specific embodiments of the present invention, the preparation method of the traditional Chinese medicine composition comprises: taking a formula amount of one or a combination of two or more of Magnolia officinalis, charred Areca nut, stewed grass fruit, ephedra, bitter almond, Notopterygium wilfordii, ginger, patchouli, Perilla frutescens, Atractylodes lancea, Poria cocos, Atractylodes macrocephala, gypsum, charred hawthorn, charred Liushenqu, charred malt, earthworm, Cynanchum chinense, Mianma Guanzhong and / or Lemongrass seed, reflux extraction, filtering, concentrating, centrifuging, drying, and crushing to obtain an intermediate composition;

[0022] Taking the intermediate composition and mixing it with pharmaceutically acceptable excipients to prepare the Chinese medicine composition;

[0023] The reflux extraction comprises: adding 6 times of water for the first time and extracting for 1.5 hours, and adding 4 times of water for the second time and extracting for 1.0 hour.

[0024] In some specific embodiments of the present invention, the acceptable excipients include one or more of a filler, a disintegrant, a lubricant, a suspending agent, a binder, a sweetener, a flavoring agent, a preservative or a matrix.

[0025] In some specific embodiments of the present invention, the preparation method of the traditional Chinese medicine composition comprises: taking 50 parts of Magnolia officinalis, 30 parts of burnt betel nut, 30 parts of stewed tsaoko, 20 parts of ephedra, 30 parts of bitter almond, 50 parts of Notopterygium wilfordii, 50 parts of ginger, 50 parts of patchouli, 30 parts of Perilla frutescens, 50 parts of Atractylodes macrocephala, 150 parts of Poria cocos, 100 parts of Atractylodes macrocephala, 50 parts of gypsum, 30 parts of burnt hawthorn, 30 parts of burnt Liu Shenqu, 30 parts of burnt malt, 50 parts of earthworm, 50 parts of Cynanchum chinense, 30 parts of Cynomorium mongolicum, and 50 parts of Lemongrass, adding water for reflux extraction twice, combining the extracts, filtering, concentrating the filtrate to a relative density of 1.10 to 1.15, centrifuging, vacuum drying the filtrate, spray drying and crushing to obtain an intermediate composition, adding sucralose and dextrin, mixing, and obtaining the traditional Chinese medicine composition;

[0026] The reflux extraction comprises: adding 6 times of water for the first time and extracting for 1.5 hours, and adding 4 times of water for the second time and extracting for 1.0 hour.

[0027] In some specific embodiments of the present invention, the dosage form of the drug includes: one or more of decoction, granules, capsules, tablets, oral liquid, pills, tincture, syrup, gel, spray or injection.

[0028] In some specific embodiments of the present invention, the effective dose of the drug comprises 6.48 to 37.44 g of crude drug / kg of animal body weight.

[0029] In some specific embodiments of the present invention, the effective dose of the drug comprises 6.48 to 25.92 g of crude drug / kg of rat body weight.

[0030] In some specific embodiments of the present invention, the effective dose of the drug comprises 9.36-37.44 g crude drug / kg mouse body weight.

[0031] In some specific embodiments of the present invention, the administration of the drug includes one or more of oral administration, injection or external application.

[0032] The present invention provides the following beneficial effects including but not limited to:

[0033] The Chinese medicine composition of the present invention can significantly improve the body weight of animals, increase the gastric emptying rate of animals, increase the levels of serum motilin (MTL) and gastrin (GAS), and reduce the level of vasoactive intestinal peptide (VIP), indicating that the Chinese medicine composition is beneficial to weight gain, can significantly promote gastric emptying, improve gastrointestinal hormone levels, and has a good therapeutic effect on functional dyspepsia. DETAILED DESCRIPTION

[0034] The present invention discloses the use of a Chinese medicine composition in the preparation of a drug for preventing and treating functional dyspepsia. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention.

[0035] According to traditional Chinese medicine research, spleen deficiency and qi stagnation are the main pathogenesis of FD, and the core treatment method is to strengthen the spleen and regulate qi. The present invention provides an application of a Chinese medicine composition in preparing a drug for treating or preventing functional dyspepsia, the Chinese medicine composition comprising: 1-100 parts of Magnolia officinalis, 1-100 parts of charred Areca nut, 1-100 parts of simmered Tsaoko fruit, 1-100 parts of Ephedra, 1-100 parts of Bitter Apricot, 1-100 parts of Notopterygium wilfordii, 1-100 parts of Ginger, 1-100 parts of Patchouli, 1-100 parts of Perilla frutescens, 1-100 parts of Atractylodes, 1-160 parts of Poria, 1-120 parts of Atractylodes macrocephala, 1-100 parts of Gypsum, 1-100 parts of charred Hawthorn, 1-100 parts of charred Liu Shenqu, 1-100 parts of charred Malt, 1-100 parts of Pheretima, 1-100 parts of Cynanchum cyrtonema, 1-100 parts of Mianma Guanzhong, and 1-100 parts of Lemongrass. The application can be any method that is beneficial to improving the corresponding symptoms of the patient, including treatment or prevention.

[0036] Furthermore, the Chinese medicine composition includes: 10-80 parts of Magnolia officinalis, 10-80 parts of scorched betel nut, 10-80 parts of stewed tsaoko, 10-60 parts of ephedra, 10-60 parts of bitter almond, 10-80 parts of Notopterygium wilfordii, 10-60 parts of ginger, 10-80 parts of patchouli, 10-60 parts of Cyperus rotundus, 10-80 parts of Atractylodes macrocephala, 10-160 parts of Poria cocos, 10-120 parts of Atractylodes macrocephala, 10-80 parts of gypsum, 10-50 parts of scorched hawthorn, 10-80 parts of scorched Liu Shenqu, 10-60 parts of scorched malt, 10-80 parts of earthworms, 10-80 parts of Cynanchum chinense, 10-60 parts of Cynomorium fortunei, and 10-80 parts of Lemongrass seeds.

[0037] Preferably, the Chinese medicine composition comprises: 30-50 parts of Magnolia officinalis, 20-30 parts of charred Areca nut, 30-50 parts of stewed Tsaoko fruit, 20-30 parts of Ephedra, 20-30 parts of Bitter Apricot, 30-50 parts of Notopterygium wilfordii, 30-50 parts of Ginger, 30-50 parts of Patchouli, 20-30 parts of Perilla frutescens, 30-50 parts of Atractylodes lancea, 120-150 parts of Poria, 80-100 parts of Atractylodes macrocephala, 30-50 parts of Gypsum, 20-30 parts of charred Crataegus pinnatifida, 30-50 parts of charred Liu Shenqu, 20-30 parts of charred Malt, 30-50 parts of Pheretima, 30-50 parts of Cynanchum cyrtonema, 20-30 parts of Cynomorium wilfordii, and 30-50 parts of Lepidium chinense;

[0038] Preferably, the Chinese medicine composition includes: 50 parts of Magnolia officinalis, 30 parts of scorched areca nut, 30 parts of stewed tsaoko fruit, 20 parts of ephedra, 30 parts of bitter almond, 50 parts of Notopterygium wilfordii, 50 parts of ginger, 50 parts of patchouli, 30 parts of Cyperus rotundus, 50 parts of Atractylodes macrocephala, 150 parts of Poria cocos, 100 parts of Atractylodes macrocephala, 50 parts of gypsum, 30 parts of scorched hawthorn, 30 parts of scorched Liu Shenqu, 30 parts of scorched malt, 50 parts of earthworm, 50 parts of Cynomorium wilfordii, 30 parts of Cynomorium fortunei, and 50 parts of Lemongrass seeds.

[0039] The above-mentioned composition can be directly ground into powder by raw materials, or can be an extract or other forms prepared by conventional means.

[0040] Specifically, the dosage forms of the aforementioned functional dyspepsia drugs include oral dosage forms, injection dosage forms or external dosage forms.

[0041] The drug of the present invention is prepared by weighing the raw material drug in proportion, adding pharmaceutically acceptable excipients such as fillers, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, bases, etc., and preparing according to conventional production methods in the pharmaceutical field to prepare conventional dosage forms acceptable to pharmacy, including but not limited to decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays, and injections.

[0042] The present invention also provides a method for preparing any of the aforementioned Chinese medicine compositions, the method comprising:

[0043] Weigh Magnolia officinalis, scorched areca nut, stewed tsaoko, ephedra, bitter almond, notopterygium wilfordii, ginger, patchouli, perilla, atractylodes, Poria, Atractylodes macrocephala, gypsum, scorched hawthorn, scorched Liushenqu, scorched malt, earthworm, Cynanchum chinense, Cynomorium morganianum, and Semen tiliaceum, extract twice with water, add 6 times the amount of water for the first time and extract for 1.5 h, add 4 times the amount of water for the second time and extract for 1.0 h, combine the extracts, filter, concentrate the filtrate to a relative density of 1.10-1.15, centrifuge and filter, and dry the filtrate.

[0044] Specifically, the above preparation method has the following steps:

[0045] Take 50 parts of Magnolia officinalis, 30 parts of charred Areca nut, 30 parts of stewed Tsaoko fruit, 20 parts of Ephedra, 30 parts of bitter almond, 50 parts of Notopterygium, 50 parts of ginger, 50 parts of Patchouli, 30 parts of Perilla frutescens, 50 parts of Atractylodes, 150 parts of Poria, 100 parts of Atractylodes, 50 parts of Gypsum, 30 parts of charred Crataegus, 30 parts of charred Liu Shenqu, 30 parts of charred malt, 50 parts of Pheretima, 50 parts of Cynanchum indica, 30 parts of Cynomorium mongolicum, and 50 parts of Lemongrass seeds, add water and reflux extract twice, add 6 times of water for the first time, extract for 1.5h, add 4 times of water for the second time, extract for 1.0h, combine the extracts, filter, concentrate the filtrate to a relative density of 1.10-1.15, centrifuge and filter, vacuum dry the filtrate, spray dry and crush to obtain an intermediate composition, add sucralose and dextrin, mix well, and obtain granules.

[0046] The composition of the present invention can significantly improve the body weight of animals, increase the gastric emptying rate of animals, increase the levels of serum motilin (MTL) and gastrin (GAS), and reduce the level of vasoactive intestinal peptide (VIP), indicating that the Chinese medicine composition is beneficial to weight gain, can significantly promote gastric emptying, improve gastrointestinal hormone levels, and has a good therapeutic effect on functional dyspepsia.

[0047] The following experiments, if no specific conditions are specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The APIs or excipients, reagents or instruments used, if the manufacturer is not specified, are all conventional products that can be purchased commercially. Unless otherwise specified, all percentages, ratios, proportions or parts are by weight.

[0048] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the present invention.

[0049] Unless otherwise specified, the raw materials and reagents used in the application of the Chinese medicine composition provided by the present invention in the preparation of a medicament for preventing and treating functional dyspepsia can all be purchased from the market.

[0050] The present invention will be further described below in conjunction with embodiments:

[0051] Preparation of Chinese medicine composition granules

[0052] The Chinese medicine composition of this embodiment is prepared from the following raw materials: 50 grams of Magnolia officinalis, 30 grams of scorched betel nut, 30 grams of stewed tsaoko, 20 grams of ephedra, 30 grams of bitter almond, 50 grams of Notopterygium wilfordii, 50 grams of ginger, 50 grams of patchouli, 30 grams of Cyperus rotundus, 50 grams of Atractylodes macrocephala, 150 grams of Poria, 100 grams of Atractylodes macrocephala, 50 grams of gypsum, 30 grams of scorched hawthorn, 30 grams of scorched Liu Shenqu, 30 grams of scorched malt, 50 grams of earthworm, 50 grams of Cynomorium fortunei, 30 grams of Cynomorium cyrtonema, and 50 grams of Lemongrass.

[0053] The Chinese medicine composition is prepared according to the following method:

[0054] Take the above medicinal materials, add water and reflux extract twice, add 6 times water for the first time, extract for 1.5 hours, add 4 times water for the second time, extract for 1.0 hours, combine the extracts, filter, concentrate the filtrate to a relative density of 1.10-1.15, centrifuge and filter, vacuum dry the filtrate, spray dry and crush to obtain an intermediate composition, add sucralose and dextrin, mix well, and obtain the Chinese medicine composition granules.

[0055] Example 1 Effect of rhubarb on rat spleen deficiency functional dyspepsia model

[0056] Experimental Materials

[0057] Animals: SD rats, SPF grade, male, 150-170 g, 60 in total, purchased from Nantong University.

[0058] The experimental mouse maintenance feed was purchased from Jiangsu Collaborative Pharmaceutical Bioengineering Co., Ltd., which complies with GB14924.1 "General Quality Standard for Experimental Animal Formula Feed", and the production license number is Su Feed Certificate (2019) 01003. Drug: Kaiwei Jianpi Pills, Li Shizhen Pharmaceutical Co., Ltd., specification: 1 gram per 10 pills, batch number: 201911005.

[0059] Test drug: Chinese medicine composition granules prepared in Preparation Example, provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0060] Reagents: Rhubarb: Pizhou Kangmei Chinese Medicinal Materials Planting Professional Cooperative, specification: 20kg / bag, batch number: Y2201058; Gum Arabic, Shanghai Shenggong, specification: 100g / bottle, batch number: GB25BA0025; Carbon powder, Shanghai Shenggong, specification: 1kg / bag, batch number: H302BA0013; Rat motilin (MTL) ELISA kit: Shanghai Shenggong, specification: 96T / box, batch number: D731179-0096; Rat gastrin (GAS) ELISA kit: Shanghai Shenggong, specification: 96T / box, batch number: D731177-0096.

[0061] Instruments: electronic balance, METTLER TOLEOD, model: MS1003S101; animal weight scale, Shanghai Xiangchuan Electronic Scale Co., Ltd., model: ACX-SC-DA; electronic balance, Shanghai Zhuojing Electronic Co., Ltd., model: BSM220.4; multifunctional microplate reader, MD Company, USA, model: Flexstation3.

[0062] Experimental methods

[0063] Weigh 6 kg of rhubarb and add 8 times the amount of water (48 L), soak for 60 min, quickly heat to boiling, boil for 10 min, pour out the liquid, extract twice, combine the two liquids, filter and concentrate to 3 L to make rhubarb decoction (raw drug amount is 2 g / mL), and store at 4°C for later use.

[0064] After 3 days of adaptive feeding of rats, except for 10 in the blank control group, the remaining 50 animals were modeled with rhubarb decoction. 2g / mL rhubarb decoction was gavaged (10mL / kg), twice a day, and the model was established for 7 consecutive days. After the modeling, they were randomly divided into groups according to body weight, with 10 rats in each group. The low, medium and high dose groups of the Chinese medicine composition were gavaged with 6.48, 12.96 and 25.92g of crude drug / kg, respectively, and the Kaiwei Jianpi Pill group was gavaged with 1.63g / kg, with a gavage volume of 10mL / kg. The blank control group and the model group were gavaged with 10mL / kg of pure water, respectively. Each group was given once a day for 7 consecutive days.

[0065] Detection index: ① Record the rate of change of body weight. ② Gastric emptying rate determination: After the administration, rats in each group fasted for 24h and drank water freely. Solid paste (10% activated carbon powder, 10% gum arabic) was diluted with warm water and stirred evenly to prepare 300mL of about 300g of black semi-solid paste. Each rat in each group was gavaged with 2mL each. After 30min, 10% chloral hydrate was used for anesthesia. The abdominal cavity was opened, the total weight of the stomach was weighed (m), and the net weight of the stomach was weighed after washing the stomach contents and drying (m1). Gastric emptying rate = [1-(m-m1) / mass of gavage nutrient semi-solid paste] × 100%. ③ Determination of gastrointestinal hormone levels: Blood was collected from the abdominal aorta of anesthetized rats. After standing for 30min, it was centrifuged at 3500rpm at 4℃ for 10min, and the supernatant was taken for use. According to the operating steps in the kit instructions, ELISA was used to detect motilin (MTL) and gastrin (GAS) in serum.

[0066] The results showed that compared with the blank control group, the weight of rats in each group decreased significantly after modeling, with statistical differences (P<0.01). After administration of Kaiwei Jianpi Pills and the Chinese medicine composition, the weight of rats in each group recovered. Except for the high-dose Chinese medicine composition group, the other groups showed statistical differences compared with the blank control group (P<0.05). The results are shown in Table 1.

[0067] After 7 days of administration, the gastric emptying rate of rats in the model group was significantly lower than that in the blank control group (P<0.05). Compared with the model group, the gastric emptying rates of rats in the low, medium and high dose groups of the Chinese medicine composition and the Kaiwei Jianpi Pill group were increased to varying degrees, among which the medium and high dose groups of the Chinese medicine composition and the Kaiwei Jianpi Pill group had significant differences (P<0.05). The results are shown in Table 2.

[0068] After 7 days of administration, the serum MTL and GAS levels of rats in the low, medium and high dose groups of the Chinese medicine composition and the Kaiwei Jianpi Pill group were restored to varying degrees compared with the model group. Compared with the model group, the serum MTL levels of the Kaiwei Jianpi Pill and the low, medium and high dose groups of the Chinese medicine composition were significantly increased (P<0.05, P<0.01). Compared with the model group, the serum GAS levels of the low, medium and high dose groups of the Chinese medicine composition and the Kaiwei Jianpi Pill group were significantly increased (P<0.05, P<0.01). The results are shown in Table 3.

[0069] Table 1 Effects of rhubarb on body weight in rat spleen deficiency model ( n=10)

[0070]

[0071] Note: Compared with the blank control group, * P<0.05, ** P<0.01.

[0072] Table 2 Effects on gastric emptying rate in rats ( n=10)

[0073]

[0074] Note: Compared with the blank control group, * P<0.05; compared with the model group, △ P<0.05.

[0075] Table 3 Effects on serum MTL and GAS levels in rats ( n=10)

[0076]

[0077] Note: Compared with the model group, △ P<0.05, △△ P<0.01, △△△ P<0.001.

[0078] Experimental Example 2 Effect of irregular diet combined with L-arginine on the functional dyspepsia model in mice

[0079] Animals: ICR mice, SPF grade, half male and half female, 60 in total, weighing 9-11 g, were purchased from Nantong University.

[0080] The experimental mouse maintenance feed was purchased from Jiangsu Collaborative Pharmaceutical Bioengineering Co., Ltd., which complies with GB14924.1 "General Quality Standard for Experimental Animal Formula Feed", and the production license number is Su Feed Certificate (2019) 01003. Drug: Domperidone Tablets, Xi'an Janssen Pharmaceutical Co., Ltd., batch number: LCJ4286; specification: 10 mg / tablet.

[0081] Test drug: the Chinese medicine composition granules prepared in the preparation example, provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd. Drug dosage: The daily dosage of crude drug for humans is 288 g of crude drug, and the clinical dosage for adults (calculated as 70 kg) is 4.1 g of crude drug / kg. The equivalent dosage for mice is calculated to be 37.44 g of crude drug / kg. This dosage is set as the high dosage, and the low, medium, and high dosage groups are set according to the dosage ratio of 0.25:0.5:1, with dosages of 9.36, 18.72, and 37.44 g of crude drug / kg, respectively, which are equivalent to 2.3, 4.6, and 9.1 times the clinical dosage, respectively.

[0082] Reagents: L-arginine, sigma, specification: 100g / bottle, batch number: SLCF6696; gum arabic, Shanghai Bioengineering, specification: 100g / bottle, batch number: GB25BA0025; carbon powder, Shanghai Bioengineering, specification: 1kg / bag, batch number: H302BA0013; sodium chloride solution, Shijiazhuang Siyao Co., Ltd., specification: 500mL / bottle, batch number: 1803193205; mouse gastrin enzyme-linked immunosorbent assay kit, Shanghai Bioengineering, specification: 96T / box, batch number: 1516AD0369; mouse vasoactive intestinal peptide enzyme-linked immunosorbent assay kit, Shanghai Bioengineering, specification: 96T / box, batch number: 1516AD0370.

[0083] Instruments: electronic balance, METTLER TOLEOD, model: MS1003S101; animal weight scale, Shanghai Xiangchuan Electronic Scale Co., Ltd., model: ACX-SC-DA; electronic balance, Shanghai Zhuojing Electronic Co., Ltd., model: BSM220.4; multifunctional microplate reader, MD Company, USA, model: Flexstation3.

[0084] Experimental methods: 60 ICR mice were randomly divided into 6 groups, 10 mice in each group, half of them were male and half were female. The cages and animals were re-marked, namely the blank control group, model group, low-, medium- and high-dose groups of Chinese medicine composition (9.36, 18.72, 37.44 g crude drug / kg) and the positive control group of domperidone tablets (6.13 mg / kg). Except for the blank control group, the mice in the other groups were fed for 2 days and fasted for 1 day, and the cycle was implemented for a total of 15 days. On the 11th day of modeling, 3.7 g / kg of L-arginine was intraperitoneally injected, and on the 12th-15th days, 1.85 g / kg of L-arginine was intraperitoneally injected. The comprehensive modeling lasted for 15 days. On the 16th day of modeling, the animals in each group were given drug or purified water (20 mL / kg) once a day for 7 consecutive days. On the 22nd day, the semi-solid paste was gavaged at a volume of 20 mL / kg 1 hour after drug administration. After 10 minutes, blood was collected from the mouse orbits, centrifuged, and serum was separated.

[0085] Detection indicators: ① General observation: weigh and record the weight of the mouse, observe its coat gloss, stool characteristics and activity, etc. ② Gastric emptying measurement: quickly remove the mouse's stomach. Record the weight of the stomach filled with semi-solid m, cut the stomach along the greater curvature, and then clean the semi-solid, record the empty stomach weight m1, and calculate the gastric residual rate according to the following formula: Gastric residual rate (%) = (m-m1) / V×100%. ③ Determination of gastrointestinal hormone levels: According to the operating steps of the kit instructions, ELISA method was used to detect gastrin (GAS) and vasoactive intestinal peptide (VIP) in serum.

[0086] The results showed that compared with the blank control group, the weight of mice in each group after modeling was significantly reduced, with statistical differences (P<0.01, P<0.05). After the administration of domperidone and Chinese medicine compounds in three dose groups, the weight of mice in each group was not significantly different from that in the model group (P>0.05). The results are shown in Table 4.

[0087] Compared with the model group, the gastric residual rate of the domperidone tablets and the high-dose Chinese medicine combination group was significantly reduced, with statistical difference (P<0.05). The results are shown in Table 5.

[0088] Compared with the model group, the serum GAS levels in the domperidone tablets, medium-dose and high-dose groups of Chinese herbal compounds were significantly increased (P<0.05). The VIP content in the low-, medium- and high-dose groups of domperidone tablets and Chinese herbal compounds was significantly reduced, with statistical differences (P<0.05, P<0.01). The results are shown in Table 6.

[0089] Table 4 Effects of irregular diet combined with L-arginine on body weight in mice with functional dyspepsia ( n=10)

[0090]

[0091] Note: Compared with the blank control group, * P<0.05, ** P<0.01; compared with the model group, △ P<0.05.

[0092] Table 5 Effects on gastric residual rate ( n=10)

[0093]

[0094] Note: Compared with the model group, △ P<0.05, △△ P<0.01.

[0095] Table 6 Effects on gastrointestinal hormone levels ( n=10)

[0096]

[0097] Note: Compared with the model group, △ P<0.05, △△ P<0.01.

[0098] The Chinese medicine composition proposed by the present invention can effectively improve body weight, significantly promote gastric emptying, improve serum gastrointestinal hormone levels, and has a good therapeutic effect on functional dyspepsia.

[0099] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. Use of a Chinese medicine composition in the preparation of a medicament for treating and / or preventing functional dyspepsia; The Chinese medicine composition comprises: The invention comprises one or a combination of two or more of 1-100 parts of Magnolia officinalis bark, 1-100 parts of burnt Areca catechu, 1-100 parts of stewed Tsaoko fruit, 1-100 parts of Ephedra sinica, 1-100 parts of Bitter Apricot, 1-100 parts of Notopterygium wilfordii, 1-100 parts of Ginger, 1-100 parts of Patchouli, 1-100 parts of Cyperus rotundus, 1-100 parts of Atractylodes macrocephala, 1-160 parts of Poria cocos, 1-120 parts of Atractylodes macrocephala, 1-100 parts of Gypsum, 1-100 parts of burnt Crataegus pinnatifida, 1-100 parts of burnt Liu Shenqu, 1-100 parts of burnt malt, 1-100 parts of Pheretima, 1-100 parts of Cynomorium longituba, 1-100 parts of Cyperus rotundus and / or 1-100 parts of Semen Lepidium.

2. The use according to claim 1, characterized in that The treatment and / or prevention of functional dyspepsia includes any of the following: (I), improving body mass; and / or (II), promoting gastric emptying; and / or (III) Improve gastrointestinal hormone levels.

3. The use according to claim 2, characterized in that The improvement of gastrointestinal hormone levels includes any of the following: (I), increase serum motilin level; and / or (II), increasing serum gastrin levels; and / or (III) Reduce serum vasoactive intestinal peptide levels.

4. The use according to any one of claims 1 to 3, characterized in that The Chinese medicine composition comprises: 10-80 parts of Magnolia officinalis, 10-80 parts of charred Areca catechu, 10-80 parts of stewed Tsaoko fruit, 10-60 parts of Ephedra sinica, 10-60 parts of Bitter Apricot, 10-80 parts of Notopterygium wilfordii, 10-60 parts of Ginger, 10-80 parts of Patchouli, 10-60 parts of Cyperus rotundus, 10-80 parts of Atractylodes macrocephala, 10-160 parts of Poria cocos, 10-120 parts of Atractylodes macrocephala, 10-80 parts of Gypsum, 10-50 parts of charred Crataegus pinnatifida, 10-80 parts of charred Liu Shenqu, 10-60 parts of charred malt, 10-80 parts of Pheretima, 10-80 parts of Cynomorium wilfordii, 10-60 parts of Cyperus rotundus and / or 10-80 parts of Lepidium chinense, or a combination of two or more thereof.

5. The use according to any one of claims 1 to 4, characterized in that: The Chinese medicine composition comprises: 30-50 parts of Magnolia officinalis, 20-30 parts of burnt betel nut, 30-50 parts of stewed grass fruit, 20-30 parts of ephedra, 20-30 parts of bitter almond, 30-50 parts of Notopterygium wilfordii, 30-50 parts of ginger, 30-50 parts of patchouli, 20-30 parts of Perilla frutescens, 30-50 parts of Atractylodes lancea, 120-150 parts of Poria cocos, 80-100 parts of Atractylodes macrocephala, 30-50 parts of gypsum, 20-30 parts of burnt hawthorn, 30-50 parts of burnt six Shenqu, 20-30 parts of burnt malt, 30-50 parts of earthworm, 30-50 parts of Cynanchum cyrtonema, 20-30 parts of Cynomorium wilfordii and / or 30-50 parts of Lepidium chinense; Preferentially, one or a combination of two or more of 50 parts of Magnolia officinalis, 30 parts of scorched Areca nut, 30 parts of stewed Tsaoko fruit, 20 parts of Ephedra, 30 parts of Bitter Apricot, 50 parts of Notopterygium wilfordii, 50 parts of Ginger, 50 parts of Patchouli, 30 parts of Perilla frutescens, 50 parts of Atractylodes macrocephala, 150 parts of Poria, 100 parts of Atractylodes macrocephala, 50 parts of Gypsum, 30 parts of scorched Crataegus pinnatifida, 30 parts of scorched Liu Shenqu, 30 parts of scorched malt, 50 parts of Pheretima, 50 parts of Cynanchum chinense, 30 parts of Cynomorium mongolicum and / or 50 parts of Semen Lepidium.

6. The use according to any one of claims 1 to 5, characterized in that The preparation method of the traditional Chinese medicine composition comprises: taking one or a combination of two or more of magnolia bark, burnt betel nut, stewed tsaoko, ephedra, bitter almond, notopterygium wilfordii, ginger, patchouli, perilla, atractylodes, tuckahoe, atractylodes macrocephala, gypsum, burnt hawthorn, burnt six-shenqu, burnt malt, earthworm, cynanchum chinense, mianma guanzhong and / or scutellaria baicalensis seed in a prescribed amount, refluxing extraction, filtering, concentrating, centrifuging, drying and pulverizing to obtain an intermediate composition; Taking the intermediate composition and mixing it with pharmaceutically acceptable excipients to prepare the Chinese medicine composition; The reflux extraction comprises: adding 6 times of water for the first time and extracting for 1.5 hours, and adding 4 times of water for the second time and extracting for 1.0 hour.

7. The use according to any one of claims 1 to 6, characterized in that The effective dose of the drug includes 6.48 to 37.44 g of crude drug / kg of animal body weight.

8. The use according to any one of claims 1 to 7, characterized in that The effective dose of the drug includes 6.48-25.92 g of crude drug / kg of rat body weight.

9. The use according to any one of claims 1 to 8, characterized in that The effective dose of the drug includes 9.36-37.44 g of crude drug / kg of mouse body weight.

10. The use according to any one of claims 1 to 9, characterized in that The administration method of the drug includes: one or more of oral administration, injection or external application.

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