Traditional Chinese medicine composition capable of replenishing qi to invigorate spleen as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a qi-tonifying spleen-tonifying traditional Chinese medicine composition and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 to 15 parts of radix pseudostellariae, 5 to 10 parts of rhizoma atractylodis macrocephalae, 5 to 10 parts of pericarpium citri reticulatae, 10 to 15 parts of malt, 5 to 10 parts of poria cocos, 5 to 10 parts of medicated leaven, 5 to 10 parts of fructus crataegi, 5 to 10 parts of rhizoma dioscoreae, 5 to 10 parts of semen coicis, 5 to 10 parts of semen nelumbinis, 1 to 5 parts of herba lophatheri, 10 to 15 parts of radix paeoniae alba, 10 to 20 parts of fructus ziziphi jujubae, 1 to 5 parts of herba eupatorii and 1 to 6 parts of fructus momordicae. The traditional Chinese medicine composition for tonifying qi and spleen provided by the invention takes qi tonifying and spleen strengthening as the basis, dampness resolving and diuresis inducing, digestion promoting and stagnation removing as the key treatment method, is skillfully matched with the products for softening liver and relieving urgency, clearing heat and promoting salivation and relieving restlessness, and moistening lung and relieving sore throat, takes into account possible syndromes, and is especially suitable for conditioning and treating spleen and stomach qi deficiency type chronic digestive system diseases and sub-health status.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a spleen-yang tonifying traditional Chinese medicine composition, a preparation method and application thereof. BACKGROUND

[0002] In the theory of traditional Chinese medicine, the spleen and stomach are the acquired constitution, and the source of qi and blood, and dampness is one of the important factors leading to many diseases of the human body. As a heavy turbid and sticky yin evil, dampness is easy to block the qi movement and damage the spleen yang, leading to dysfunction of transportation and transformation, and various symptoms such as loss of appetite, abdominal distension and diarrhea, heavy limbs, edema and the like caused by spleen deficiency and dampness accumulation, which seriously affect people's physical health and quality of life. Spleen-yang tonifying and dampness-eliminating is the core treatment method of traditional Chinese medicine for the pathogenesis of dampness-evil disturbing the spleen. Therefore, developing safe and effective spleen-yang tonifying and dampness-eliminating products has always been a research focus and priority in the field of traditional Chinese medicine. At present, there are many existing spleen-yang tonifying and dampness-eliminating traditional Chinese medicine compositions and related products on the market, which are mostly based on traditional classic prescriptions for compatibility, and most of them are based on single or simple pathogenesis for formula design. For example, some products overemphasize dampness-elimination and water-elimination, and use a large amount of warm and dry dampness-eliminating drugs, which can relieve the symptoms of dampness accumulation to a certain extent, but easily aggravate the condition of heat stagnation and fluid consumption; at the same time, the existing formula rarely considers the mutual relationship between the liver and the spleen, and fails to assist the spleen by soothing the liver and regulating qi, resulting in a significant reduction in the treatment effect. SUMMARY

[0003] In order to solve the problem that most of the existing products mainly have the effects of simple spleen-yang tonifying or dampness-eliminating, without considering the symptoms of food accumulation, heat stagnation, liver-spleen disharmony and the like, and are difficult to effectively cope with the above-mentioned complex syndromes, the present application aims at the core pathogenesis of spleen and stomach qi deficiency and dysfunction of transportation and transformation, and considers the syndromes of dampness accumulation, food accumulation, heat stagnation and liver-spleen disharmony, and provides a spleen-yang tonifying traditional Chinese medicine composition, a preparation method and application thereof, to synergistically treat chronic digestive system diseases such as fatigue, loss of appetite, abdominal fullness and the like caused by spleen and stomach qi deficiency by spleen-yang tonifying, dampness-eliminating, food-digesting and stagnation-removing.

[0004] According to the first aspect of the present application, a spleen-yang tonifying traditional Chinese medicine composition is provided, which is composed of the following raw materials in parts by weight: Taizishen 10-15 parts, Baizhu 5-10 parts, Chenpi 5-10 parts, Maiya 10-15 parts, Fuling 5-10 parts, Shenqu 5-10 parts, Shanzha 5-10 parts, Shanyao 5-10 parts, Yiyiren 5-10 parts, Lianzi 5-10 parts, Danzhu ye 1-5 parts, Baishao 10-15 parts, Dazao 10-20 parts, Pelian 1-5 parts, Luohan guo 1-6 parts.

[0005] The spleen-yang tonifying traditional Chinese medicine composition provided by the present application can obviously improve the symptoms of chronic gastritis caused by spleen and stomach qi deficiency, such as fatigue, abnormal stool, lazy speech, abdominal pain, abdominal fullness, pale and yellowish complexion and the like. In the formula: Radix Pseudostellariae and Rhizoma Atractylodis Macrocephalae are the monarch herbs. Radix Pseudostellariae is sweet and bitter in taste, and is neutral in nature, and it is associated with the spleen and lung meridians. It can tonify qi and invigorate the spleen, and it can also produce fluid and moisten the lung. It is the core herb for tonifying qi and invigorating the spleen in this formula, and it is especially suitable for the treatment of spleen-qi deficiency with fluid consumption or deficiency failing to be tonified. Rhizoma Atractylodis Macrocephalae is bitter and sweet in taste, and is warm in nature, and it is associated with the spleen and stomach meridians. It can invigorate the spleen and tonify qi, and it can also dry dampness and drain water. It is used together with Radix Pseudostellariae to enhance the function of invigorating the spleen and tonifying qi. Meanwhile, its dampness-drying property can help to eliminate dampness that obstructs the middle energizer, and it is the key herb for invigorating the spleen and eliminating dampness.

[0006] The ministerial herbs are Rhizoma Dioscoreae, Fructus Nelumbinis, Fructus Hordei Germinatus, Fructus Crataegi, Pericarpium Citri Reticulatae, Tuckahoe, Radix Rehmanniae Preparata, Perilla, Massa Medicata Fermentata. Rhizoma Dioscoreae can tonify qi and nourish yin, and it can also tonify the spleen, lung and kidney, arrest diarrhea, and it can also assist Radix Pseudostellariae and Rhizoma Atractylodis Macrocephalae in invigorating the spleen. It can also nourish yin and arrest diarrhea, and it can tonify without drying. Fructus Nelumbinis is sweet and astringent in taste, and it is neutral in nature, and it is associated with the spleen, kidney and heart meridians. It can tonify the spleen, arrest diarrhea, tonify the kidney, astringe essence, nourish the heart and calm the spirit, and it can also assist in invigorating the spleen. Fructus Hordei Germinatus can promote digestion and relieve food retention, and it can also invigorate the spleen and stimulate the appetite. Massa Medicata Fermentata is sweet and pungent in taste, and it is warm in nature, and it is associated with the spleen and stomach meridians. It can relieve food retention and harmonize the stomach. Fructus Crataegi is sour and sweet in taste, and it is slightly warm in nature. It can relieve food retention and accumulation. Pericarpium Citri Reticulatae is pungent and bitter in taste, and it is warm in nature. It can regulate qi, invigorate the spleen, dry dampness and reduce phlegm, and it can also promote digestion and relieve food retention and accumulation. Tuckahoe is sweet and bland in taste, and it is neutral in nature. It can drain water and eliminate dampness, and it can also invigorate the spleen and calm the heart. It can also eliminate dampness from the small intestine. Radix Rehmanniae Preparata is sweet in taste, and it is cold in nature. It can drain water and eliminate dampness, and it can also invigorate the spleen and arrest diarrhea. It can also clear heat and eliminate pus. Perilla is pungent in taste, and it is neutral in nature. It is associated with the spleen, stomach and lung meridians. It can aromatize and eliminate dampness, and it can also awaken the spleen and stimulate the appetite, and it can also release the exterior and relieve summer-heat. It can also eliminate dampness from the middle energizer, awaken the spleen and stimulate the appetite, and it can also relieve abdominal fullness and poor appetite caused by dampness obstruction.

[0007] The auxiliary herbs are Radix Paeoniae Alba, Lophatheri Folium, and Fructus Jujubae. Radix Paeoniae Alba is bitter and sour in taste, and it is cold in nature. It can nourish blood and regulate menstruation, and it can also astringe yin and arrest sweating, and it can also soothe the liver and relieve pain. It is used in a large amount to nourish blood and soothe the liver, and it can prevent the deficiency of the spleen leading to the overabundance of the liver (spleen deficiency leading to the relative overabundance of the liver), and it can relieve abdominal pain or discomfort in the lateral costal region. On the other hand, its astringent property can prevent the excessive consumption of qi caused by pungent and dispersing herbs. Lophatheri Folium is sweet and bland in taste, and it is cold in nature. It is associated with the heart, stomach and small intestine meridians. It can clear heat and drain fire, and it can also relieve thirst and arrest polyuria. It can also clear heat from the heart and stomach, relieve thirst, and promote the excretion of dampness and heat. Its cold nature can also moderate the dryness of some warm herbs in the formula. Fructus Jujubae is sweet in taste, and it is warm in nature. It is associated with the spleen, stomach and heart meridians. It can tonify the center and boost qi, and it can also nourish blood and calm the spirit. It can also moderate the properties of the herbs, and it can assist Radix Pseudostellariae and Rhizoma Atractylodis Macrocephalae in tonifying qi and invigorating the spleen, and it can also nourish blood to moderate Radix Paeoniae Alba. Its sweet and moderate property can prevent the stomach from being damaged by the digestion- and food-retention herbs. It can also moderate the properties of the herbs and induce the herbs into the lung.

[0008] The whole formula eliminates and supplements simultaneously, with supplementation as the main approach. Herbs with sweet and neutral or sweet and warm properties such as Pseudostellaria heterophylla, Atractylodes macrocephala, Dioscorea opposita, Nelumbo nucifera Gaertn. seed, and Ziziphus jujuba Mill. are used to tonify qi and strengthen the spleen to treat the root cause; malt, medicated leaven, hawthorn, and dried tangerine peel are used to promote digestion and remove stagnation, promote qi movement and aid transportation to treat the superficial symptoms. Tonifying deficiency does not hinder pathogenic factors (food retention and damp stagnation), and digestion and guidance do not damage healthy qi. Equal emphasis is placed on strengthening the spleen and promoting the transformation of dampness and inducing diuresis. The combination of herbs such as Atractylodes macrocephala, Poria cocos, Coix lacryma-jobi L., and Eupatorium fortunei Turcz. combines strengthening the spleen and promoting the transportation of dampness with aromatic dampness elimination and mild diuretic dampness percolation, leaving no hiding place for damp pathogens and restoring the transportation and transformation function of the spleen and stomach. The liver and lungs are taken into account, and qi and blood are regulated. White peony root is used in large doses to soothe the liver and relieve spasm, preventing the liver wood from attacking the spleen; it is combined with lophatherum gracile Brongn. to clear the heat of the heart and stomach and promote the production of fluid and relieve vexation; momordica grosvenori Swingle is used to moisten the lungs, soothe the throat, and promote defecation, embodying the idea of "strengthening the earth to generate metal" (strengthening the spleen to benefit the lungs) and overall regulation. Jujube combined with white peony root nourishes blood and harmonizes nutrient qi. Cold and warm herbs are used together, and the medicinal properties are mild. Although there are warm and dry herbs such as Atractylodes macrocephala and dried tangerine peel in the formula, they are combined with herbs with mild, cold, or cool and moistening properties such as Pseudostellaria heterophylla, Dioscorea opposita, Nelumbo nucifera Gaertn. seed, white peony root, lophatherum gracile Brongn., and momordica grosvenori Swingle, making the overall medicinal properties of the whole formula tend to be mild, neither dry nor greasy, suitable for long-term conditioning of syndromes of spleen deficiency complicated with dampness and stagnation, and accompanied by mild stagnant heat or fluid injury. <> <>

[0009] The traditional Chinese medicine composition for tonifying qi and strengthening the spleen provided by the present invention takes tonifying qi and strengthening the spleen (Pseudostellaria heterophylla, Atractylodes macrocephala, Dioscorea opposita, Nelumbo nucifera Gaertn. seed, and Ziziphus jujuba Mill.) as the foundation, promoting the transformation of dampness and inducing diuresis (Poria cocos, Coix lacryma-jobi L., and Eupatorium fortunei Turcz.), and promoting digestion and removing stagnation (malt, medicated leaven, hawthorn, and dried tangerine peel) as the key treatment methods, and ingeniously combines herbs for soothing the liver and relieving spasm (white peony root), clearing heat and promoting the production of fluid and relieving vexation (lophatherum gracile Brongn.), and moistening the lungs and soothing the throat (momordica grosvenori Swingle), taking into account the possible co-existing syndromes. The whole formula has a clear structure, rigorous compatibility, and mild medicinal properties. It is a comprehensive conditioning formula that equally emphasizes strengthening the spleen, promoting the transformation of dampness, promoting digestion, regulating the liver, and harmonizing the lungs, and is especially suitable for the treatment and regulation of chronic digestive system diseases and sub-health states with spleen deficiency, dampness stagnation, food retention, and mixture of deficiency and excess. <> <>

[0010] All raw materials are prepared in accordance with the Chinese Pharmacopoeia and the National Processing Specifications. The specific sources are as follows: <> Pseudostellaria heterophylla: The dried tuberous root of Stellaria media (L.) Cyr. <> Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm. <><0> Atractylodes macrocephala Koidz. of Caryophyllaceae. <> <>

[0011] Atractylodes macrocephala: The dried rhizome of Atractylodes macrocephala Koidz. <> Citrus reticulata Blanco of Asteraceae. <> <>

[0012] Dried tangerine peel: The dried ripe pericarp of Citrus reticulata Blanco <> Hordeum vulgare L. and its cultivated varieties of Rutaceae. <> <>

[0013] Malt: The mature fruit of Hordeum vulgare L. <> Poria cocos (Schw.) Wolf of Poaceae, germinated and dried. <> <>

[0014] Poria cocos: The dried sclerotium of Wolfiporia cocos (Schw.) Ryvarden and Gilbn. <> Crataegus pin, natiida Bge.var.major N.E.Br. of Polyporaceae. <> <>

[0015] Medicated leaven: A medicinal leaven prepared by fermenting polygonum hydropiper L., artemisia annua L., almond paste, adzuki bean, and fresh xanthium sibiricum Patrin ex Widder with flour or wheat bran. <>

[0016] Hawthorn: dried mature fruit of Crataegus pinnatifida Bge. var. major N. E. Hansen Crataegus pin. nati fida Bge. or hawthorn Dioscorea opposita Thunb. .

[0017] Chinese yam: dried rhizome of Dioscorea opposita Thunb. Coix lacryma-jobi L.var.mayuen (Roman.) Stapf .

[0018] Semen coicis: dried mature seed of Coix lacryma-jobi L. var. ma-yor N. E. Hansen Nelumbo nucifera Gaertn. .

[0019] Lotus seed: dried mature seed of Nelumbo nucifera Gaertn. Lophatherum gracile Brongn. .

[0020] Lophatherum gracile Brongn: dried stem and leaf of Lophatherum gracile Brongn. Paeonia lactiflora Pall. .

[0021] White peony root: dried root of Paeonia lactiflora Pall. Eupatorium fortunei Turcz. .

[0022] Jujube: mature fruit of Ziziphus jujuba Mill. var. spinosa (Bunge) Hu.

[0023] Pellitory: dried aboveground part of Eupatorium fortunei H. Bnll. Siraitia grosvenorii (Swingle) C. Jeffrey ex A. .

[0024] Monk fruit: dried fruit of Siraitia grosvenorii Swingle M. Lu et Z.Y.Zhang ​ .

[0025] In some embodiments, the Qi-boosting and spleen-strengthening traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12-15 parts of radix pseudostellariae, 8-10 parts of rhizoma atractylodis macrocephalae, 8-10 parts of pericarpium citri reticulatae, 12-15 parts of fructus hordei, 8-10 parts of poria cocos, 8-10 parts of massa medicata fermentata, 8-10 parts of hawthorn, 8-10 parts of Chinese yam, 8-10 parts of semen coicis, 8-10 parts of lotus seed, 3-5 parts of lophatherum gracile, 12-15 parts of white peony root, 15-20 parts of jujube, 3-5 parts of pellitory, and 3-6 parts of monk fruit.

[0026] In some embodiments, the Qi-boosting and spleen-strengthening traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of radix pseudostellariae, 10 parts of rhizoma atractylodis macrocephalae, 10 parts of pericarpium citri reticulatae, 15 parts of fructus hordei, 10 parts of poria cocos, 10 parts of massa medicata fermentata, 10 parts of hawthorn, 10 parts of Chinese yam, 10 parts of semen coicis, 10 parts of lotus seed, 5 parts of lophatherum gracile, 15 parts of white peony root, 20 parts of jujube, 5 parts of pellitory, and 6 parts of monk fruit.

[0027] According to a second aspect of the present application, there is provided a use of a Qi-boosting and spleen-strengthening traditional Chinese medicine composition in the preparation of a medicament for treating chronic digestive system disease of spleen and stomach Qi deficiency type or regulating sub-health state of spleen and stomach Qi deficiency type.

[0028] According to the third aspect of the present application, a traditional Chinese medicine preparation prepared from the Yiqi Jianpi traditional Chinese medicine composition is provided. The traditional Chinese medicine preparation includes water decoction, granules, paste, pills, powder, capsules, tablets, and mixture, etc. The granules are prepared according to the Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Granules issued by the State Drug Administration.

[0029] In some embodiments, when the traditional Chinese medicine preparation is prepared into different dosage forms, at least one of pharmaceutically acceptable adjuvants, including sustained-release agents, excipients, fillers, binders, humectants, disintegrants, absorption promoters, adsorption carriers, surfactants, and lubricants, can be added.

[0030] According to the fourth aspect of the present application, a preparation method of the Yiqi Jianpi traditional Chinese medicine preparation is provided. When the preparation is prepared into a paste, the method includes the following steps: (1) soaking the raw materials, decocting the soaked raw materials with water for 1-3 times, combining the decocted liquid, fully squeezing the residue, combining the squeezed liquid with the decocted liquid, and placing for 6-7 hours for precipitation, and then filtering through an 80-mesh sieve; (2) heating the filtered liquid of step (1) to boiling, and continuously stirring until the color of the liquid is darkened and the liquid becomes viscous, and then filtering through a 100-mesh sieve; (3) continuously heating the filtered liquid of step (2) with continuous stirring until the liquid is viscous or forms beads when water is dripped onto it, and then the paste is obtained.

[0031] The preparation method of the Yiqi Jianpi traditional Chinese medicine preparation described above, when the preparation is prepared into a water decoction, includes the following steps: soaking the raw materials, decocting the soaked raw materials with water for 2 times, combining the decocted liquid, fully squeezing the residue, combining the squeezed liquid with the decocted liquid, and then the water decoction is obtained.

[0032] In some embodiments, when decocting with water for 2 times, the water level is 15-25 cm higher than the raw materials during the first decocting, the soaking time is 2-8 hours, and the decocting time is 2-4 hours; and during the second decocting, the water level is sufficient to submerge the raw materials, and the decocting time is 1-2 hours.

[0033] According to the fifth aspect of the present application, the Yiqi Jianpi traditional Chinese medicine preparation is used for preparing a medicine for treating chronic digestive system diseases of the spleen and stomach qi deficiency type or regulating the sub-health state of the spleen and stomach qi deficiency type. The chronic digestive system diseases of the spleen and stomach qi deficiency type include chronic gastritis, indigestion, and gastrointestinal dysfunction. The main symptoms of chronic gastritis of the spleen and stomach qi deficiency type include body fatigue, abnormal stool, lazy speech, continuous abdominal pain, abdominal fullness, and pale complexion.

[0034] In some embodiments, the Yiqi Jianpi traditional Chinese medicine preparation is used for preparing a medicine for treating chronic digestive system diseases of the spleen and stomach qi deficiency type or regulating the sub-health state of the spleen and stomach qi deficiency type.

[0035] In the formula design, the application is based on the TCM overall concept and syndrome differentiation and treatment theory, and various Chinese medicinal materials are scientifically matched. The product is prepared by using radix pseudostellariae, rhizoma atractylodis macrocephalae and other products for tonifying qi and invigorating the spleen as the monarch drug to improve the problem of spleen-stomach qi deficiency and transportation failure from the root; using poria cocos, coix seed and other water-draining and dampness-removing drugs as the ministerial drug to effectively resolve the obstruction of dampness and turbidity; matching hawthorn, god's recipe and other food-digesting and accumulation-removing medicinal materials to specifically solve the symptoms of food accumulation and indigestion; at the same time, adding folium phyllostachy sylvestris rehd, radix paeoniae alba and other heat-clearing and body-fluid-producing drugs to improve the yin fluid consumption due to heat stagnation, and using radix paeoniae alba and other liver-spleen regulating drugs to regulate the liver and spleen. The combined use of various drugs not only has clear primary and secondary, but also has mutual coordination, realizes comprehensive and accurate treatment of complex syndromes, and overcomes the defects of single formula and difficulty in considering multiple symptoms of the existing products.

[0036] In the product form and application field, the application breaks through the limitation of traditional dosage forms, and according to the characteristics of the formula, the product is a comprehensive conditioning prescription for invigorating the spleen, removing dampness, digesting food, regulating the liver and harmonizing the lung, which is suitable for the conditioning of spleen-stomach qi deficiency type chronic digestive system diseases and sub-health state, especially for the conditioning of spleen deficiency, dampness accumulation, food accumulation and complex chronic digestive system diseases and sub-health state, and the preparation process is optimized. The strict process parameter control system ensures the stability and uniformity of product quality, and each batch of product can realize stable and effective treatment of complex syndromes, which makes up for the shortcomings of the existing preparation process.

[0037] The application realizes innovation and breakthrough in formula, preparation process and product application, and provides a safer, more effective and personalized treatment option for patients with spleen-stomach qi deficiency and complex syndromes, which has important clinical significance and broad market prospect. DETAILED DESCRIPTION

[0038] The application will be further described in detail below in combination with specific examples, and it should be noted that the following examples are only used to better explain the content of the application and do not limit the scope of the application. The process steps not disclosed in the examples are prior art. Unless otherwise specified, the following raw materials are commercially available. The pressing of the drug residue in the application is to squeeze out the moisture in the drug residue. The pressing method can use the existing drug residue press or presser, or use a pressure filter bag, that is, the drug residue is placed in the pressure filter bag and squeezed. One part in the examples can be 1 g or 1 kg.

[0039] Example 1 A Chinese medicinal composition for tonifying qi and invigorating the spleen, which is composed of the following raw materials by weight: radix pseudostellariae 15 parts, rhizoma atractylodis macrocephalae 10 parts, pericarpium citri reticulatae 10 parts, fructus avenae 15 parts, poria cocos 10 parts, god's recipe 10 parts, hawthorn 10 parts, rhizoma dioscoreae 10 parts, coix seed 10 parts, lotus seed 10 parts, folium phyllostachy sylvestris rehd 5 parts, radix paeoniae alba 15 parts, fructus jujubae 20 parts, pellitory 5 parts, momordica grosvenori 6 parts.

[0040] The Yiqi Jianpi traditional Chinese medicine composition is prepared into a paste (a paste preparation), and the preparation method is as follows: The raw materials are poured into a special medicine soaking container, and drinking water is added, with the water surface being about 15 cm higher than the drinking pieces. The soaking time is about 2 h. The soaked drinking pieces are put into a medicine pot for decoction, and boiling is continued for about 2 h. The first medicine juice is obtained by filtration. Water is added to the pot to immerse the drinking pieces. Boiling is continued for 1 h, and the first medicine juice is obtained by filtration. The two times of medicine juice are combined. The medicine residue is fully squeezed, and the squeezed medicine juice is combined with the above-mentioned medicine juice to obtain a medicine liquid. The medicine liquid is placed in a transfer container and is left to stand for about 6 h. The medicine liquid is filtered through an 80-mesh medicine screen. The filtered medicine liquid is placed in a purple copper medicine pot, and is heated with a strong fire until boiling. Stirring is continued until the color of the medicine liquid is deepened and the medicine liquid has a certain thickness. The medicine liquid is filtered through a 100-mesh screen. The filtered medicine liquid is poured into a purple copper pot and is continuously heated with a weak fire, and stirring is continuously performed. When the medicine juice "hangs a flag" or "drops water into beads" when the stirring rod is lifted, the paste is obtained.

[0041] The paste product is subjected to "insoluble substance detection". 5 ml of the paste product is placed in a glass test container, 200 ml of 90℃ water is added, and stirring is continuously performed. The paste should be completely dissolved within 5 min. After dissolution, the container is observed after being left to stand for 3 min. There should be no foreign matters such as coke blocks and medicine residues in the container. There is no coke smell or peculiar smell. The appearance of the paste is fine, black and shiny. The paste is thick and moderate, is in a semi-solid state, and has a fragrance of medicine, which is qualified.

[0042] The qualified paste is quickly poured into a special packaging machine which has been cleaned and disinfected in advance for distribution, 10 g per bag.

[0043] Example 2 The Yiqi Jianpi traditional Chinese medicine composition is prepared into a paste (a paste preparation), and the preparation method is as follows:

[0044] The Yiqi Jianpi traditional Chinese medicine composition is prepared into a paste (a paste preparation), and the preparation method is as follows: The raw materials are poured into a special medicine soaking container, and drinking water is added, with the water surface being about 15 cm higher than the drinking pieces. The soaking time is about 2 h. The soaked drinking pieces are put into a medicine pot for decoction, and boiling is continued for about 2 h. The first medicine juice is obtained by filtration. Water is added to the pot to immerse the drinking pieces. Boiling is continued for 1 h, and the first medicine juice is obtained by filtration. The two times of medicine juice are combined. The medicine residue is fully squeezed, and the squeezed medicine juice is combined with the above-mentioned medicine juice to obtain a medicine liquid. The medicine liquid is placed in a transfer container and is left to stand for about 6 h. The medicine liquid is filtered through an 80-mesh medicine screen.

[0045] Example 3 A spleen-invigorating traditional Chinese medicine composition, which is composed of the following raw materials in parts by weight: Taizishen 10 parts, Baizhu 5 parts, Chenpi 8 parts, Maiya 10 parts, Fuling 8 parts, Shengqu 5 parts, Shanzha 5 parts, Shanyao 8 parts, Yiyiren 5 parts, Lianzi 5 parts, Danzhu 1 part, Baishao 12 parts, Dazao 10 parts, Pelian 1 part, Luohan 3 parts.

[0046] The spleen-invigorating traditional Chinese medicine composition is made into a paste according to the method of Example 1, which will not be repeated here.

[0047] Next, to illustrate the treatment and improvement of the symptoms of chronic gastritis, indigestion and other symptoms caused by spleen-stomach qi deficiency by the spleen-invigorating composition of the present application, the spleen-invigorating paste prepared in Example 1 (hereinafter referred to as the spleen-invigorating paste) is used for retrospective analysis of clinical data.

[0048] I. Source of data From January 2023 to August 2025, 100 cases of clinical patient records from the outpatient department of a hospital in Shenzhen, Guangdong Province.

[0049] II. Research design A retrospective analysis study and a telephone follow-up method are used for comparison before and after treatment.

[0050] III. Inclusion and exclusion criteria 1. Inclusion criteria (1) Outpatients diagnosed with chronic gastritis, indigestion, fatigue, gastrointestinal dysfunction, etc.; (2) Patients with spleen-stomach qi deficiency syndrome; (3) Outpatients who used the spleen-invigorating paste prepared in Example 1 of the present application for intervention (10g twice a day, for 15 days); (4) Patients with follow-up records or who used the medicine for nearly three months and cooperated with the telephone follow-up.

[0051] 2. Exclusion criteria (1) Outpatients who do not meet the criteria for spleen-stomach qi deficiency; (2) Patients who used other oral Chinese medicines for intervention; (3) Patients with severe primary diseases of the liver, kidney, hematopoietic system, endocrine system, etc. and mental illness.

[0052] IV. Evaluation index According to the "Guidelines for Clinical Research of New Chinese Medicines" (Trial Version), the TCM syndrome score is evaluated. This guideline includes 12 common symptoms, which are assigned and classified according to 0 points, 2 points, 4 points and 6 points, as shown in Table 1. The total score interval is 0 to 72 points, and the higher the score, the deeper the symptoms and degree of spleen-stomach qi deficiency. The efficacy evaluation criteria are as follows: (1) Cure: total score decreased by more than 95%; (2) Effective: total score decreased by more than 70%; (3) Improved: total score decreased by 30% to 70%; (4) Invalid: total score change less than 30%.

[0053] Calculated by the method of nimodipine: Symptom score improvement rate = (total score before treatment - total score after treatment) ÷ total score before treatment x 100% Table 1 Different symptom score table

[0054] V. Research results According to the Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine, the total symptom score decreased by 30% to 70% is improved; the total score decreased by more than 70% is effective, and the score results before and after treatment are shown in Tables 2-5, and part of the recheck / visit records are shown in Table 4. The results show that among the 100 cases included in the observation, the symptom score improvement rate is all ≥30%, among which 97 cases are improved, 3 cases are effective, and the overall effective rate is 100%, indicating that the traditional Chinese medicine composition of the present application is effective for patients with spleen-stomach qi deficiency syndrome.

[0055] Table 2 Score before treatment

[0056] Table 3 Score after treatment

[0057] Table 4 Part of recheck / visit records

[0058] Table 5 Efficacy evaluation results (unit: cases)

[0059] Eliminate the case where the score before and after treatment of each symptom is 0, and then compare and analyze the improvement of the corresponding symptoms before and after treatment, as shown in Table 6, the results show that the traditional Chinese medicine composition of the present application can significantly improve the symptoms of patients with spleen-stomach qi deficiency syndrome such as poor appetite, anorexia, body fatigue, abdominal distension after eating, abnormal stool, lazy speech, abdominal pain, nausea and vomiting, abdominal distension, pale complexion, etc.

[0060] Table 6 Symptom improvement

[0061] The above descriptions are merely some specific embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for tonifying qi and invigorating the spleen, characterized in that, It is composed of the following raw materials by weight: 10-15 parts of radix pseudostellariae, 5-10 parts of rhizoma atractylodis macrocephalae, 5-10 parts of pericarpium citri reticulatae, 10-15 parts of malt, 5-10 parts of poria cocos, 5-10 parts of massa medicata fermentata, 5-10 parts of hawthorn, 5-10 parts of dioscorea, 5-10 parts of coix lachryma-jobi, 5-10 parts of nelumbium speciosum, 1-5 parts of lophatherum gracile, 10-15 parts of radix paeoniae alba, 10-20 parts of fructus jujubae, 1-5 parts of pterocephalus totatus, 1-6 parts of momordica grosvenori.

2. The Qi-boosting and spleen-nourishing traditional Chinese medicine composition according to claim 1, characterized in that, It is composed of the following raw materials by weight: 12-15 parts of radix pseudostellariae, 8-10 parts of rhizoma atractylodis macrocephalae, 8-10 parts of pericarpium citri reticulatae, 12-15 parts of malt, 8-10 parts of poria cocos, 8-10 parts of massa medicata fermentata, 8-10 parts of hawthorn, 8-10 parts of dioscorea, 8-10 parts of coix lachryma-jobi, 8-10 parts of nelumbium speciosum, 3-5 parts of lophatherum gracile, 12-15 parts of radix paeoniae alba, 15-20 parts of fructus jujubae, 3-5 parts of pterocephalus totatus, 3-6 parts of momordica grosvenori.

3. The Qi-boosting and Spleen-nourishing Traditional Chinese Medicine composition according to claim 1, characterized in that, It is composed of the following raw materials by weight: 15 parts of radix pseudostellariae, 10 parts of rhizoma atractylodis macrocephalae, 10 parts of pericarpium citri reticulatae, 15 parts of malt, 10 parts of poria cocos, 10 parts of massa medicata fermentata, 10 parts of hawthorn, 10 parts of dioscorea, 10 parts of coix lachryma-jobi, 10 parts of nelumbium speciosum, 5 parts of lophatherum gracile, 15 parts of radix paeoniae alba, 20 parts of fructus jujubae, 5 parts of pterocephalus totatus, 6 parts of momordica grosvenori.

4. Use of the qi-tonifying and spleen-strengthening traditional Chinese medicine composition of any one of claims 1-3 in the preparation of a medicine for treating chronic digestive system diseases of the spleen-stomach qi deficiency type or regulating the sub-health state of the spleen-stomach qi deficiency type.

5. A traditional Chinese medicine preparation prepared from the qi-tonifying and spleen-strengthening traditional Chinese medicine composition of any one of claims 1-3, wherein the traditional Chinese medicine preparation comprises a decoction, granules, a paste, pills, powder, capsules, tablets or a mixture.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, It also includes pharmaceutically acceptable adjuvants.

7. The preparation method of the traditional Chinese medicine preparation according to claim 5, characterized in that, When the traditional Chinese medicine preparation is a paste, the preparation method is as follows: (1) Soak the raw materials in water, decoct the soaked raw materials in water for 1-3 times, combine the decoctions obtained in each time, and then fully squeeze the residues, combine the squeezed juice with the decoctions, and then stand for 6-7 hours, and then pass through a 80-mesh sieve; (2) Boil the filtered liquid obtained in step (1) while continuously stirring until the color of the liquid is darkened and the liquid becomes thick, and then pass through a 100-mesh sieve; (3) Continue to heat the filtered liquid obtained in step (2) while continuously stirring until the liquid is thick enough.

8. The preparation method of claim 7, characterized in that, When the decoction is prepared for 2 times in step (1), the first time of decoction is performed by immersing the raw materials in water with a water level higher than the raw materials by 15-25 cm, and then soaking for 2-8 hours and decocting for 2-4 hours; and the second time of decoction is performed by immersing the raw materials in water until the raw materials are submerged, and then decocting for 1-2 hours.

9. Use of the traditional Chinese medicine preparation of claim 5 in the preparation of a medicine for treating chronic digestive system diseases of the spleen-stomach qi deficiency type or regulating the sub-health state of the spleen-stomach qi deficiency type.

10. Use according to claim 9, characterized in that, The chronic digestive system diseases of the spleen-stomach qi deficiency type include chronic gastritis, indigestion or gastrointestinal dysfunction.

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