Traditional Chinese medicine composition for treating distention and fullness as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating distention and fullness and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition comprises the following raw materials: 10-30 parts of codonopsis pilosula, 20-30 parts of medicated leaven, 20-30 parts of endothelium corneum gigeriae galli, 20-30 parts of fried malt, 5-10 parts of rhizoma pinellinae praeparata, 10-20 parts of mangnolia officinalis, 5-10 parts of bighead atractylodes rhizome, 8-16 parts of pericarpium citri reticulatae, 6-12 parts of fructus amomi, 10-20 parts of curcuma zedoary, 10-20 parts of elecampane, 5-10 parts of rhizoma cyperi, 5-10 parts of fructus aurantii and 5-10 parts of liquorice. Wherein codonopsis pilosula has the effects of tonifying middle-Jiao and Qi and strengthening spleen and stomach and is a monarch drug Medicated leaven, endothelium corneum gigeriae galli and fried malt are compatible, can strengthen spleen and stomach and promote digestion, and are used as ministerial drugs; rhizoma atractylodis macrocephalae, fructus amomi, rhizoma pinellinae praeparata, pericarpium citri reticulatae and mangnolia officinalis have the effects of regulating qi, eliminating dampness and strengthening the spleen, rhizoma cyperi and fructus aurantii have the effects of regulating qi, eliminating dampness, radix aucklandiae and The liquorice is used for harmonizing the medicines and is a conductant medicine; the medicines are compatible to achieve the effects of tonifying qi and spleen, invigorating stomach and promoting digestion, and regulating qi and removing dampness.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating fullness and a preparation method and application thereof. BACKGROUND

[0002] The Huangdi Neijing first proposed the name of abdominal pain, which laid an important theoretical foundation for the cognition and treatment of diseases of the spleen and stomach system. Zhang Zhongjing discussed the syndrome differentiation and treatment of abdominal pain in detail in the Synopsis of Golden Chamber, and used different prescriptions for different etiologies, which laid the foundation for the treatment of abdominal pain. Li Dongyuan's Spleen and Stomach Theory in the Jin and Yuan Dynasties emphasized that'spleen and stomach deficiency leads to all diseases', highlighting the core position of the spleen and stomach in health, and its theory has a profound influence on later generations. Abdominal distension was called 'fullness' in ancient times, and the Jingyue Complete Works pointed out that fullness has deficiency and excess, and treatment needs to be based on deficiency and excess. Spleen and stomach dysfunction can also cause symptoms such as vomiting, abdominal pain, abdominal distension, hematochezia, belching and acid reflux, and these diseases have similar etiologies and treatment methods, mainly focusing on regulating the spleen and stomach.

[0003] The theory of spleen and stomach is the core of traditional Chinese medicine. Doctors have a common understanding of various diseases, believing that various factors can cause dysfunction of the spleen and stomach. However, traditional prescriptions have limitations in dealing with modern complex diseases. For example, the Xiangsha Liujunzi Decoction has the effects of benefiting qi and resolving phlegm, but has three major defects: the prescription is biased towards tonifying, and lacks comprehensive regulation of combined syndromes; most commercially available Chinese patent medicines continue the single tonifying approach, making it difficult to deal with complex pathogenesis; traditional decoctions are inconvenient to cook and have poor taste, and modern dosage forms such as tablets and capsules have low bioavailability and weak mucosal repair effects. SUMMARY

[0004] Therefore, one of the purposes of the present application is to provide a traditional Chinese medicine composition for treating fullness.

[0005] The second purpose of the present application is to provide a preparation method of the traditional Chinese medicine composition.

[0006] The third purpose of the present application is to provide the application of the traditional Chinese medicine composition or the preparation method.

[0007] The fourth purpose of the present application is to provide a medicine for treating fullness.

[0008] In order to achieve the above purposes, the present application provides the following technical solutions: A traditional Chinese medicine composition for treating fullness, comprising the following raw materials in parts by weight: 10-30 parts of radix codonopsis, 20-30 parts of Jian Shengqu, 20-30 parts of Gini Jiang, 20-30 parts of fried barley, 5-10 parts of radix bisolae, 10-20 parts of Magnolia officinalis, 5-10 parts of Atractylodes, 8-16 parts of Pericarpium Citri Reticulatae, 6-12 parts of Amomum villosum, 10-20 parts of Curcuma zedoaria, 10-20 parts of Aucklandia, 5-10 parts of Citrus aurantium, and 5-10 parts of Glycyrrhiza uralensis.

[0009] The application further provides a preparation method of the traditional Chinese medicine composition, comprising the following steps: The raw materials are weighed according to the proportion; The Aucklandia, dried tangerine or orange peel and Amomum villosum are mixed, dried and crushed to obtain a mixture 1, the mixture 1 is mixed with water to perform distillation extraction, and the distillation liquid, residue and remaining liquid are collected; The Radix Codonopsis, Gekko, Rhizoma Pinelliae, Curcuma zedoaria, Chinese herb, roasted wheat, Rhizoma Cyperi, Magnolia officinalis, Atractylodes, Citrus aurantium, Glycyrrhiza and the residue and remaining liquid are mixed to obtain a mixture 2, the mixture 2 is mixed with water to perform decoction, and the decoction liquid is collected; The decoction liquid is filtered and left overnight, the supernatant is collected and concentrated to obtain a concentrated liquid, and the concentrated liquid is filtered to obtain a filtrate; The sodium benzoate and sucrose are added to the filtrate, mixed under heating, the distillation liquid is added, and water is added to constant volume, and the mixture is cooled and then divided into portions.

[0010] Preferably, the Aucklandia, dried tangerine or orange peel and Amomum villosum are dried at 60℃, and then crushed to pass through a 20-mesh sieve.

[0011] Preferably, the mixture 1 is mixed with water at a mass ratio of 1:5, and the distillation extraction is performed at a temperature of 100℃ for 30-45 min.

[0012] Preferably, the mixture 2 is mixed with water at a mass ratio of 1:(4-6), and the decoction is performed for 1.5-2.5 h.

[0013] Preferably, the relative density of the concentrated liquid is 1.10-1.15.

[0014] Preferably, the proportions of the traditional Chinese medicine raw material, sodium benzoate, sucrose and constant volume are 770g:3g:450g:1000mL based on the mass of the traditional Chinese medicine raw material.

[0015] The application further provides an application of the traditional Chinese medicine composition or the preparation method in the preparation of a medicine for treating fullness.

[0016] The application further provides a medicine for treating fullness, wherein the medicine comprises the traditional Chinese medicine composition.

[0017] Preferably, the medicine is prepared by adding a pharmaceutically acceptable excipient to obtain a powder, a decoction, a pill, a capsule, a tablet, a granule and an oral liquid.

[0018] Compared with the prior art, the application has the following beneficial effects: The present application provides a kind of traditional Chinese medicine composition for treating fullness, for treating spleen and stomach system diseases of spleen and stomach qi deficiency, symptom is diet, belching nausea, abdominal distension and pain etc..The traditional Chinese medicine composition of the present application initiates "supplementing-eliminating-digesting" four-dimensional synergistic model, breaks through the single supplementing architecture of traditional spleen-invigorating formula, wherein radix codonopsis has the effect of tonifying middle energizer and invigorating spleen and stomach, and is the monarch drug;Jian Shenqu, Jinejin and fried wheat germ are combined, and have the effect of invigorating spleen and stomach and eliminating food stagnation, and are the ministerial drugs;Baizhu, Sharen, Banxia, Chenpi and Huopu regulate qi and dry dampness to invigorate spleen, Xiangfu and Jikeli regulate qi and remove dampness, Muxiang and Ezhuhong eliminate stagnation, and are the auxiliary drugs;Gancao harmonizes all drugs, and is the ministerial drug;All drugs are combined to tonify qi and invigorate spleen, invigorate stomach and eliminate food stagnation, regulate qi and remove dampness, and expand the clinical drug selection of spleen and stomach diseases. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 It is a flow chart of the preparation method; wherein, the shaded part represents that it is carried out in D-level clean area, and * is a quality control point. DETAILED DESCRIPTION

[0020] The present application provides a kind of traditional Chinese medicine composition for treating fullness, according to weight fraction, it includes the following raw materials: radix codonopsis 10-30 parts, Jian Shenqu 20-30 parts, Jinejin 20-30 parts, fried wheat germ 20-30 parts, Banxia 5-10 parts, Huopu 10-20 parts, Baizhu 5-10 parts, Chenpi 8-16 parts, Sharen 6-12 parts, Ezhuhong 10-20 parts, Muxiang 10-20 parts, Xiangfu 5-10 parts, Jikeli 5-10 parts and Gancao 5-10 parts.The addition amount of radix codonopsis in the traditional Chinese medicine composition of the present application is preferably 15-25 parts, more preferably 20 parts;The addition amount of Jian Shenqu is preferably 22-28 parts, more preferably 25 parts;The addition amount of Jinejin is preferably 22-28 parts, more preferably 25 parts;The addition amount of fried wheat germ is preferably 22-28 parts, more preferably 25 parts;The addition amount of Banxia is preferably 8 parts;The addition amount of Huopu is preferably 13-17 parts, more preferably 15 parts;The addition amount of Baizhu is preferably 8 parts;The addition amount of Chenpi is preferably 10-14 parts, more preferably 12 parts;The addition amount of Sharen is preferably 8-11 parts, more preferably 10 parts;The addition amount of Ezhuhong is preferably 13-17 parts, more preferably 15 parts;The addition amount of Muxiang is preferably 13-17 parts, more preferably 15 parts;The addition amount of Xiangfu is preferably 8 parts;The addition amount of Jikeli is preferably 8 parts;The addition amount of Gancao is preferably 8 parts.The present application does not have special limitation to the specific source of the above raw materials, and the conventional commercially available products in the art can be used.

[0021] In the traditional Chinese medicine composition of the present application, radix codonopsis is the monarch drug.Radix codonopsis helps to improve the digestive function of spleen and stomach, relieve anorexia, abdominal distension and other discomforts, has the effect of tonifying middle energizer and invigorating spleen and stomach, and plays a major role in the whole prescription, so that the whole prescription has the effect of tonifying qi and invigorating spleen.

[0022] In the traditional Chinese medicine composition of the present application, the following are used as ministerial drugs: Jian Shenqu, Jinejin and Fried Malt. Jian Shenqu is a kind of medicinal agent made of wheat flour, bran and various medicinal herbs after fermentation, which has the effects of invigorating the spleen, promoting digestion, regulating qi and eliminating dampness, and relieving the exterior. It can be used to treat food retention, sudden vomiting and diarrhea, dysentery, cold and headache, and loss of appetite in children. Jinejin has the effects of enhancing the function of the spleen and stomach, improving food retention and abdominal distension, and promoting nutrient absorption, and is mainly used to relieve overeating, abdominal distension and loss of appetite in children. Fried Malt is a kind of traditional Chinese medicine made of barley after germination, drying and frying, which has the effects of promoting digestion, relieving lactation and abdominal distension, and soothing the liver and relieving depression, and is used for food retention and breast distension. The combination of Jinejin, Fried Malt and the monarch drug can invigorate the spleen and stomach and eliminate food retention.

[0023] In the traditional Chinese medicine composition of the present application, the following are used as ministerial drugs: Baizhu, Sharen, Fahanxia, Chenpi, Huhou, Xiangfu, Jike, Muxiang and Ezhuteng. Baizhu can enhance the function of the spleen and stomach, promote digestion and absorption, improve abdominal distension and diarrhea, limb weakness, edema and abnormal sweating, and enhance immunity and physical fitness. Sharen can be used to resolve internal dampness and regulate qi, and has the effects of eliminating dampness, relieving abdominal distension and pain, improving indigestion and preventing miscarriage, and is often used to improve abdominal distension, nausea and vomiting, and discomfort during pregnancy. Fahanxia has the effects of resolving phlegm, relieving cough and stopping vomiting, and is often used to treat excessive phlegm, cough, chest distension and abdominal distension, and symptoms of nausea and vomiting. Chenpi has the effects of promoting digestion, relieving abdominal distension and pain, resolving phlegm and improving cough, and is often used to relieve loss of appetite, excessive phlegm and cough. Huhou can regulate qi and eliminate dampness, and has the effects of promoting intestinal peristalsis, relieving abdominal distension, eliminating excess water in the body and improving indigestion, and is often used to treat abdominal distension, loss of appetite, excessive phlegm and cough. The combination of Baizhu, Sharen, Fahanxia, Chenpi and Huhou can regulate qi, eliminate dampness and invigorate the spleen. Xiangfu can soothe the liver and relieve depression, regulate qi and relieve pain, and is used for liver depression and qi stagnation, chest and hypochondrium distension and pain, hernia pain, breast distension and pain, spleen and stomach qi stagnation, abdominal distension and pain, irregular menstruation and menstrual pain. Jike can regulate qi and eliminate dampness, and is used for chest and hypochondrium qi stagnation, abdominal distension and pain, food retention, internal phlegm and organ prolapse. The combination of Xiangfu and Jike can regulate qi and eliminate dampness. Muxiang can regulate qi and relieve pain, invigorate the spleen and promote digestion, and is used for chest and abdominal distension and pain, diarrhea and indigestion, and loss of appetite. Ezhuteng can regulate qi and eliminate blood stasis, eliminate food retention and relieve pain, and is used for blood and qi heart pain, food retention, abdominal distension and pain, blood stasis and irregular menstruation, menstrual pain, mass and blockage, and injury. The combination of Muxiang and Ezhuteng can regulate qi and eliminate food retention. Baizhu, Sharen, Fahanxia, Chenpi, Huhou, Xiangfu, Jike, Muxiang and Ezhuteng are used as ministerial drugs, which can further enhance the effects of the composition.

[0024] In the traditional Chinese medicine composition of the present application, Ganzao is used as a drug, which has the effect of regulating all drugs.

[0025] The traditional Chinese medicine composition of the present application initiates a four-dimensional synergistic model of "tonifying-activating-eliminating-digesting", and the prescription is reasonable, and the drugs are compatible, which can jointly tonify qi and invigorate the spleen, strengthen the stomach and eliminate dampness.

[0026] The present application also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: weighing the raw materials according to the proportion; mixing, drying and crushing the Radix Aucklandiae, Pericarpium Citri Reticulatae and Fructus Amomi to obtain mixture 1, mixing the mixture 1 with water to perform distillation extraction, collecting the distillation liquid, residue and remaining liquid; mixing the Radix Codonopsis, Endothelium Corneum Corii Asini, Rhizoma Pinelliae, Rhizoma Curcumae, Radix et Rhizoma Praeparata cum Succo Glycyrrhizae, Fructus Amomi Rotundus, Rhizoma Atractylodis Macrocephalae, Fructus Aurantii, Radix Glycyrrhizae, residue and remaining liquid to obtain mixture 2, mixing the mixture 2 with water to perform decoction, and collecting the decoction liquid; filtering the decoction liquid and standing overnight, collecting the supernatant, concentrating to obtain a concentrated liquid, filtering the concentrated liquid to obtain a filtrate; adding sodium benzoate and sucrose to the filtrate, mixing under heating, adding the distillation liquid, adding water to constant volume, and cooling to obtain a final product.

[0027] In the preparation method, the Radix Aucklandiae, Pericarpium Citri Reticulatae and Fructus Amomi are preferably dried at 60 DEG C; and after drying, they are preferably crushed to pass through a 20-mesh sieve. The mixture 1 is preferably mixed with water at a mass ratio of 1:5; the temperature of distillation extraction is preferably 100 DEG C; the pressure of distillation extraction is preferably ≤0.25 Mpa; the present application preferably boils by heating, adjusts the steam pressure, maintains the boiling temperature at 100 DEG C, and collects the distillation liquid by decoction; and the time of distillation extraction is preferably 30-45 min. The effective components of the Radix Aucklandiae, Pericarpium Citri Reticulatae and Fructus Amomi in the prescription mainly exist in the volatile oil thereof, and the present application can fully extract the effective components in the Radix Aucklandiae, Pericarpium Citri Reticulatae and Fructus Amomi by distillation extraction.

[0028] In the preparation method, the mixture 2 is preferably mixed with water at a mass ratio of 1:(4-6), and in some examples, the mass ratio can be 1:4, 1:5 or 1:6; the decoction time is preferably 1.5-2.5 h, and more preferably 2 h. The number of decoction is preferably 1-3 times, and more preferably 2 times. The combined decoction liquid is preferably concentrated to a relative density of 1.10-1.15 (20 DEG C). The mixing under heating is preferably mixing under stirring, heating to 100 DEG C and maintaining for 30 min. The mass ratio of the traditional Chinese medicine raw material, sodium benzoate, sucrose and constant volume is 770 g:3 g:450 g:1000 mL. The intermediate product obtained after cooling to 15-25 DEG C is preferably the qualified product, and the relative density of the intermediate product is 1.03-1.18 (20 DEG C), and the pH value is 4.0-6.0.

[0029] The application also provides application of the traditional Chinese medicine composition or the preparation method in preparing a medicine for treating fullness; the fullness is a spleen and stomach system disease caused by spleen and stomach qi deficiency, and symptoms include indigestion, belching, nausea, abdominal distension and abdominal pain.

[0030] The application also provides a medicine for treating fullness, which comprises the traditional Chinese medicine composition; the medicine can also add a pharmaceutically acceptable adjuvant, and the adjuvant can obtain a powder, a decoction, a pill, a capsule, a tablet, a granule and an oral liquid.

[0031] The technical solutions provided by the application are described in detail below in combination with examples, but they should not be understood as limitations to the protection scope of the application.

[0032] Example 1 A traditional Chinese medicine composition for treating fullness, according to weight parts, raw materials are as follows: 20 parts of radix codonopsis, 20 parts of jian shenqu, 20 parts of chicken gizzard, 20 parts of fried wheat, 10 parts of radix pinelliae, 10 parts of pinellia ternate, 5 parts of white atractylodes, 8 parts of dried tangerine or orange peel, 6 parts of amomum villosum, 10 parts of curcuma zedoaria, 10 parts of saussurea involucrata, 5 parts of aurantii nobilis pericarpium, 5 parts of cyperus rotundus, and 5 parts of licorice.

[0033] The preparation method is as follows: The radix codonopsis, chicken gizzard, saussurea involucrata, radix pinelliae, curcuma zedoaria, dried tangerine or orange peel, amomum villosum, jian shenqu, fried wheat, cyperus rotundus, radix pinelliae, white atractylodes, aurantii nobilis pericarpium and licorice are weighed according to the prescription amount and prepared.

[0034] The saussurea involucrata, dried tangerine or orange peel and amomum villosum are dried at 60 DEG C and then crushed through a 20-mesh screen to obtain mixture 1; the mixture 1 is placed in a distiller, wetted with water according to a mass ratio of 1:5, heated and distilled (100 DEG C, 0.2 Mpa, 40 min), and the distillate, residue and remaining liquid are collected for later use.

[0035] The radix codonopsis, chicken gizzard, radix pinelliae, curcuma zedoaria, jian shenqu (wrapped with gauze), fried wheat, cyperus rotundus, radix pinelliae, white atractylodes, aurantii nobilis pericarpium, licorice, residue and remaining liquid are obtained as mixture 2; the mixture 2 is mixed with water according to a mass ratio of 1:5 and then put into an extraction tank for decocting for 2 h; the decocting liquid is collected and repeated decocting is performed twice.

[0036] The decocting liquids are combined, filtered through a 100-mesh screen, left to stand overnight, and then the supernatant is absorbed and concentrated to a concentrated liquid with a relative density of 1.15 (20 DEG C); the concentrated liquid is filtered to obtain a filtrate.

[0037] Based on the weight of the raw Chinese medicine materials, and according to the ratio of raw Chinese medicine materials, sodium benzoate, sucrose, and a final volume of 770g:3g:450g:1000mL, the filtrate was drawn into a mixing tank, sodium benzoate and sucrose were added, the stirrer was turned on, and the mixture was heated to 100℃ and kept at that temperature for 30 minutes. The mixture was then filtered through a 200-mesh sieve, distillate was added, and finally purified water was added to make up the volume. The jacket cooling water was turned on to cool the intermediate product to 20℃. A sample of the intermediate product was taken for testing. A relative density of 1.03~1.18 and a pH value of 4.0~6.0 indicate a qualified intermediate product. After passing the test, the solution was dispensed.

[0038] Before dispensing, the dispensing machine pipeline is disinfected with 75% ethanol, then cleaned with purified water until the nozzle sprays purified water at least 10 times. The pipeline is then rinsed three times with a qualified pharmaceutical solution. High-density polyethylene bottles are used, with each bottle containing no less than 150mL. The bottles are then sealed, leak-tested, and packaged to obtain the finished syrup.

[0039] Example 2 A traditional Chinese medicine composition for treating abdominal distension, comprising the following ingredients by weight: Codonopsis pilosula 10 parts, Shenqu (medicated leaven) 20 parts, chicken gizzard lining 20 parts, roasted malt 20 parts, prepared Pinellia ternata 5 parts, Magnolia officinalis 10 parts, Atractylodes macrocephala 5 parts, tangerine peel 8 parts, Amomum villosum 6 parts, Curcuma zedoaria 10 parts, Aucklandia lappa 10 parts, Citrus aurantium 10 parts, Cyperus rotundus 10 parts, Glycyrrhiza uralensis 5 parts.

[0040] The preparation method is the same as in Example 1.

[0041] Example 3 A traditional Chinese medicine composition for treating abdominal distension, comprising the following ingredients by weight: Codonopsis pilosula 25 parts, Shenqu (medicated leaven) 25 parts, chicken gizzard lining 25 parts, stir-fried malt 25 parts, processed Pinellia ternata 8 parts, Magnolia officinalis 15 parts, Atractylodes macrocephala 8 parts, Citrus reticulata 10 parts, Amomum villosum 10 parts, Curcuma zedoaria 15 parts, Aucklandia lappa 15 parts, Citrus aurantium 8 parts, Cyperus rotundus 8 parts, Glycyrrhiza uralensis 5 parts.

[0042] The preparation method is the same as in Example 1.

[0043] Example 4 Codonopsis pilosula 30 parts, Shenqu (medicated leaven) 30 parts, chicken gizzard lining 30 parts, stir-fried malt 30 parts, prepared Pinellia ternata 10 parts, Magnolia officinalis 20 parts, Atractylodes macrocephala 10 parts, tangerine peel 16 parts, Amomum villosum 12 parts, Curcuma zedoaria 20 parts, Aucklandia lappa 20 parts, Citrus aurantium 5 parts, Cyperus rotundus 5 parts, Glycyrrhiza uralensis 5 parts.

[0044] The preparation method is the same as in Example 1.

[0045] Comparative Example 1 The difference between this comparative example and Example 1 is that no Codonopsis pilosula was added.

[0046] Comparative Example 2 The difference between this comparative example and Example 1 is that no medicinal herbs, chicken gizzard lining, or roasted malt were added.

[0047] Comparative Example 3 A traditional Chinese medicine composition for treating abdominal distension, comprising the following ingredients by weight: Codonopsis pilosula 35 parts, Shenqu (medicated leaven) 20 parts, chicken gizzard lining 20 parts, roasted malt 20 parts, prepared Pinellia ternata 10 parts, Magnolia officinalis 10 parts, Atractylodes macrocephala 5 parts, Citrus reticulata 8 parts, Amomum villosum 6 parts, Curcuma zedoaria 10 parts, Aucklandia lappa 10 parts, Citrus aurantium 5 parts, Cyperus rotundus 5 parts, Glycyrrhiza uralensis 5 parts.

[0048] Comparative Example 4 A traditional Chinese medicine composition for treating abdominal distension, comprising the following ingredients by weight: Codonopsis pilosula 20 parts, Shenqu (medicated leaven) 10 parts, chicken gizzard lining 10 parts, stir-fried malt 10 parts, prepared Pinellia ternata 10 parts, Magnolia officinalis 10 parts, Atractylodes macrocephala 5 parts, Citrus reticulata peel 8 parts, Amomum villosum 6 parts, Curcuma zedoaria 10 parts, Aucklandia lappa 10 parts, Citrus aurantium 5 parts, Cyperus rotundus 5 parts, Glycyrrhiza uralensis 5 parts.

[0049] Comparative Example 5 A traditional Chinese medicine composition for treating abdominal distension, comprising the following ingredients by weight: Codonopsis pilosula 20 parts, Shenqu (medicated leaven) 20 parts, chicken gizzard lining 20 parts, stir-fried malt 20 parts, processed Pinellia ternata 15 parts, Magnolia officinalis 25 parts, Atractylodes macrocephala 15 parts, Citrus reticulata peel 20 parts, Amomum villosum 15 parts, Curcuma zedoaria 15 parts, Aucklandia lappa 15 parts, Citrus aurantium 8 parts, Cyperus rotundus 8 parts, Glycyrrhiza uralensis 5 parts.

[0050] Example 5 Efficacy verification trial.

[0051] To verify the clinical efficacy and safety of the traditional Chinese medicine composition of the present invention (denoted as Jianpi Hewei Syrup), a randomized, double-blind, positive-drug-controlled multicenter clinical trial was conducted.

[0052] 1. Experimental Design (1) Case selection: 270 patients aged 18-65 years who met the diagnostic criteria for "epigastric fullness" - spleen and stomach qi deficiency syndrome in the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine" were included. The main symptoms included epigastric fullness and distension, soft to the touch without pain, fluctuating in severity, and recurring; secondary symptoms included poor appetite, severe bloating after meals, relief with belching, vomiting of clear saliva, fatigue, weakness, and reluctance to speak; a pale tongue with a white coating and a weak pulse were also observed. Organic diseases such as gastric cancer were excluded.

[0053] (2) Grouping and administration: 270 patients were randomly divided into 9 groups and each group took the finished syrup prepared in Examples 1 to 4 and Comparative Examples 1 to 5, 30 mL each time, 3 times a day, orally.

[0054] 2. Observation Indicators (1) Symptom scoring: A scoring table was developed based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", including symptoms such as stomach pain, poor appetite, and loose stools, and graded as none (0 points), mild (1 point), moderate (2 points), and severe (3 points).

[0055] (2) TCM syndrome scoring: tongue appearance (pale tongue with white coating), pulse appearance (weak pulse) and changes in systemic symptoms.

[0056] (3) Safety indicators: blood routine, liver and kidney function and adverse event records.

[0057] 3. Evaluation of therapeutic effect (1) Efficacy evaluation criteria: Cure: Symptoms have completely disappeared, and the total symptom score is 0. Significant effect: Symptoms are significantly reduced, and the total symptom score decreases by ≥70%; Effective: Symptoms are alleviated, with a decrease in total symptom score of ≥30% and <70%. Ineffective: Total symptom score decreases by <30% or total symptom score increases (2) Overall effective rate (%) = (number of cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%; Significant effective rate (%) = number of cases with significant effect / total number of cases × 100%; Cured rate (%) = number of cured cases / total number of cases × 100%. The results are shown in Table 1.

[0058] Table 1. Therapeutic effects of different traditional Chinese medicine combinations

[0059] This invention selected 270 medical records that met the requirements from 2022 to 2025 for retrospective analysis. According to the results in Table 1, the total effective rate of Example 1 for treating patients with spleen and stomach qi deficiency was 90%, the cure rate was 13%, and there were 3 ineffective cases.

[0060] Example 1 (Codonopsis pilosula, Shenqu, chicken gizzard lining, and roasted malt = 20:20:20:20) showed the best efficacy, with a total effective rate of 90% and a cure rate of 13%. This demonstrates that through the synergistic effect of Codonopsis pilosula (principal drug) invigorating qi and strengthening the spleen, Shenqu (assistant drug) invigorating the spleen, regulating qi and resolving dampness, chicken gizzard lining (assistant drug) invigorating the spleen and eliminating food stagnation, and roasted malt (assistant drug) invigorating the spleen, regulating qi and promoting digestion, it significantly improves the core symptoms of spleen and stomach qi deficiency such as abdominal pain, fullness, and fatigue.

[0061] The efficacy of the formula decreased sharply when key drugs were missing: the total effective rate of Comparative Example 1 (lacking Codonopsis pilosula) dropped sharply to 33%, while the total effective rate of Comparative Example 2 (lacking Shenqu, chicken gizzard membrane, and roasted malt) was only 57%, confirming that the principal and assistant drugs are irreplaceable; the ratio of principal and assistant drugs was changed in Comparative Examples 3 and 4, but the cure rate was 0%, and the effective rate was also lower than that of Example 1, suggesting that the efficacy decreased after changing the compatibility ratio. The significant efficacy of Comparative Example 5 (with changes in adjuvant drugs) was only 33%, suggesting that the dosage of drugs that dry dampness, strengthen the spleen, and regulate qi needs to be strictly controlled.

[0062] In terms of safety, no abnormalities were found in blood routine tests, liver and kidney function, or adverse event records in all patients participating in the trial, indicating that the traditional Chinese medicine composition (Jianpi Hewei Syrup) has good safety.

[0063] In summary, clinical trials have confirmed that the efficacy of this invention depends on the completeness of the formulation and the accuracy of the compatibility ratios. Each herb is indispensable and its dosage must be strictly controlled in order to achieve both symptomatic and root-cause treatment.

[0064] Typical Cases Case 1: Patient Liu, male, 35 years old. Chief complaint: Abdominal fullness and discomfort, relieved on an empty stomach but aggravated after meals, frequent but weak belching, bland taste in the mouth, vomiting of clear saliva, and loose stools. After taking the herbal composition of Example 1 for 7 days, the abdominal pain lessened, the voice became loud and strong, and bowel movements returned to normal. No recurrence was observed during a 1-month follow-up.

[0065] Case 2: Patient Qin, female, 19 years old. Chief complaint: poor appetite, significant abdominal distension after eating, loose stools, thin white tongue coating, and weak pulse. After taking the herbal composition of Example 2 for 5 days, the patient had no adverse symptoms. No recurrence was observed during a 1-month follow-up.

[0066] Case 3: Patient Zhang, male, 52 years old. Chief complaint: persistent and unbearable bloating and discomfort, aversion to food, bland taste in the mouth without thirst, pale tongue with white coating, aversion to cold and preference for warmth, and sallow complexion. After taking the herbal composition of Example 3 for 14 days, the symptoms of bloating and discomfort and aversion to food disappeared. No recurrence was observed during a one-month follow-up.

[0067] Case 4: Patient Wang, female, 45 years old. Chief complaint: Recurrent abdominal fullness and discomfort for more than half a year, aggravated by eating, with occasional belching and acid reflux, limb weakness, mental fatigue, and stools that were sometimes loose and sometimes dry. Her tongue was pale with a white and greasy coating, and her pulse was thready and slippery. After taking the Chinese medicine composition of Example 4 for 5 days, the abdominal fullness was significantly reduced, the belching and acid reflux disappeared, her mental state improved, and her bowel movements became more regular. She continued to take the medicine for 2 weeks to consolidate the therapeutic effect, and there was no recurrence during a 1-month follow-up.

[0068] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating abdominal distension, characterized in that, The ingredients, by weight, include the following: 10-30 parts Codonopsis pilosula, 20-30 parts Shenqu (medicated leaven), 20-30 parts chicken gizzard lining, 20-30 parts roasted malt, 5-10 parts prepared Pinellia ternata, 10-20 parts Magnolia officinalis, 5-10 parts Atractylodes macrocephala, 8-16 parts dried tangerine peel, 6-12 parts Amomum villosum, 10-20 parts Curcuma zedoaria, 10-20 parts Aucklandia lappa, 5-10 parts Cyperus rotundus, 5-10 parts Citrus aurantium, and 5-10 parts Glycyrrhiza uralensis.

2. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, Includes the following steps: Weigh out each raw material according to the proportions; Costus root, dried tangerine peel and amomum villosum are mixed, dried and pulverized to obtain mixture 1. Mixture 1 is mixed with water and distilled to extract the extract. The distillate, residue and remaining liquid are collected. Mix Codonopsis pilosula, chicken gizzard lining, Pinellia ternata, Curcuma zedoaria, medicated leaven, roasted malt, Cyperus rotundus, Magnolia officinalis, Atractylodes macrocephala, Citrus aurantium, Glycyrrhiza uralensis, dregs and remaining liquid to obtain mixture 2. Mixture 2 is then decocted with water, and the decoction is collected. After filtering the decoction, let it stand overnight, collect the supernatant and concentrate it to obtain a concentrated solution. Filter the concentrated solution to obtain a filtrate. Sodium benzoate and sucrose were added to the filtrate and mixed under heating conditions. Distillate was added, and water was added to make up to volume. After cooling, the mixture was dispensed.

3. The preparation method according to claim 2, characterized in that, Costus root, dried tangerine peel, and amomum villosum were dried at 60℃ and then pulverized to pass through a 20-mesh sieve.

4. The preparation method according to claim 2, characterized in that, Mixture 1 was mixed with water at a mass ratio of 1:5; the distillation extraction conditions were: temperature 100℃, time 30~45min.

5. The preparation method according to claim 2, characterized in that, Mixture 2 is mixed with water at a mass ratio of 1:(4~6) and decocted for 1.5~2.5 hours.

6. The preparation method according to claim 2, characterized in that, The relative density of the concentrate is 1.10~1.

15.

7. The preparation method according to claim 2, characterized in that, Based on the mass of the Chinese herbal medicine raw materials, the ratio of the Chinese herbal medicine raw materials, sodium benzoate, sucrose, and the fixed volume is 770g:3g:450g:1000mL.

8. The use of the traditional Chinese medicine composition according to claim 1 or the preparation method according to any one of claims 2 to 7 in the preparation of a medicine for treating abdominal distension.

9. A medicine for treating abdominal distension, characterized in that, The drug includes the traditional Chinese medicine composition of claim 1.

10. The medicament according to claim 9, characterized in that, The drug is prepared by adding pharmaceutically acceptable excipients to obtain powders, decoctions, pills, capsules, tablets, granules, and oral liquids.

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