Traditional Chinese medicine composition and traditional Chinese medicine preparation with effects of consolidating vital essence and consolidating foundation as well as preparation method and application of traditional Chinese medicine composition and traditional Chinese medicine preparation

Abstract

The invention provides a traditional Chinese medicine composition with effects of reinforcing vital essence and consolidating basis. The traditional Chinese medicine composition comprises the following components in parts by weight: 26-35 parts of codonopsis pilosula, 12-20 parts of bighead atractylodes rhizome, 12-18 parts of poria cocos, 10-15 parts of pericarpium citri reticulatae, 7-12 parts of pinellia ternate, 3-8 parts of honey-fried licorice root, 25-33 parts of scorched hawthorn fruit, 16-23 parts of scorched medicated leaven, 8-15 parts of scorched malt, 3-7 parts of elecampane, 10-17 parts of pogostemon cablin, 2-5 parts of clove, 9-15 parts of lotus seed and 6-12 parts of fructus amomi. According to the traditional Chinese medicine composition with the effect of consolidating vital essence and consolidating body resistance, all the medicines are precisely and appropriately matched to jointly achieve the effects of invigorating spleen to eliminate dampness and tonifying spleen and qi, the immune function of the organism can be effectively improved, and a positive curative effect is achieved in the aspect of treating inflammation. Based on the traditional Chinese medicine composition, the invention also provides a traditional Chinese medicine preparation taking the traditional Chinese medicine composition as a medicinal active component, and provides a preparation method of the traditional Chinese medicine preparation.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition with the effects of nourishing the vital energy and strengthening the body, a traditional Chinese medicine preparation, and a preparation method and application thereof. Background Art

[0002] "Immunity" generally refers to the body's ability to resist foreign pathogens, eliminate aging and mutated cells, and repair tissue damage. Immunity plays a crucial role in the fight against viral infections. Beyond combating viral infections, immunity also has other important functions. For example, the immune system can eliminate aging and mutated cells in the body, thereby preventing the development of tumors. The immune system monitors and attacks abnormal cells, preventing them from developing into cancer. A stable and balanced immune system is crucial for maintaining health: when immunity is too weak, it is susceptible to infection and tumors; when immunity is too strong, autoimmune diseases may develop. The generation, maintenance, and stimulation of immunity are primarily based on a complex and sophisticated immune system, which is primarily composed of immune organs (such as lymph nodes, spleen, and thymus), immune cells (such as T cells, B cells, and macrophages), and immune molecules (such as cytokines and antibodies). Immune responses are categorized into two main types: innate immunity and acquired immunity, based on their timing, mechanism, and specificity. Innate immunity, also known as "natural immunity," is the body's innate defense mechanism. It includes physical barriers such as the skin and mucous membranes, as well as immune cells such as phagocytes and natural killer cells that respond quickly in the early stages of viral invasion. However, innate immunity has limited recognition capabilities and can only target some common pathogen patterns. Acquired immunity, also known as "adaptive immunity," is a specific defense mechanism that the body gradually develops after exposure to pathogens. Through immune memory, acquired immunity can respond quickly and effectively upon re-exposure to the same pathogen.

[0003] Yuan Qi, the fundamental energy of the human body, originates in the liver and kidneys, and circulates throughout the body, reaching the internal organs and external meridians, stimulating and maintaining the normal physiological activities of the organs, meridians, and tissues. Therefore, nourishing the Yuan Qi and strengthening the foundation plays a vital role in enhancing the body's functions and immunity.

[0004] The purpose of the present invention is to provide a traditional Chinese medicine formula with the effect of nourishing the vital energy and strengthening the body. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine formula with the effect of nourishing the vital energy and strengthening the body, which can effectively improve the immune function of the body.

[0006] The first aspect of the present invention is to provide a Chinese medicine composition having the effect of strengthening the body, comprising the following ingredients in parts by weight:

[0007] 26-35 parts of Codonopsis pilosula, 12-20 parts of Atractylodes macrocephala, 12-18 parts of Poria cocos, 10-15 parts of dried tangerine peel, 7-12 parts of Pinellia ternata, 3-8 parts of roasted liquorice root, 25-33 parts of charred hawthorn, 16-23 parts of charred Shenqu, 8-15 parts of charred malt, 3-7 parts of costus root, 10-17 parts of patchouli, 2-5 parts of cloves, 9-15 parts of lotus seeds, and 6-12 parts of Amomum villosum.

[0008] Preferably, the Chinese medicine composition having the effect of strengthening the body comprises the following ingredients in parts by weight:

[0009] 30 parts of Codonopsis pilosula, 15 parts of Atractylodes macrocephala, 15 parts of Poria cocos, 12 parts of dried tangerine peel, 9 parts of Pinellia ternata, 6 parts of roasted Licorice root, 30 parts of scorched Crataegus, 20 parts of scorched Shenqu, 10 parts of scorched malt, 5 parts of costus root, 15 parts of patchouli, 3 parts of cloves, 12 parts of lotus seeds, and 9 parts of Amomum villosum.

[0010] The second aspect of the present invention is to provide a traditional Chinese medicine preparation with the effect of nourishing the vital energy and strengthening the foundation, comprising a pharmaceutically active ingredient and a pharmaceutically acceptable excipient, wherein the pharmaceutically active ingredient is prepared from the traditional Chinese medicine composition described in the first aspect.

[0011] The third aspect of the present invention is to provide a method for preparing a Chinese medicine preparation having the effect of strengthening the body, using the Chinese medicine composition described in the first aspect, comprising the following steps:

[0012] Step S1, soaking the traditional Chinese medicine composition in an appropriate amount of water, decocting, filtering, and concentrating to obtain an extract with a relative density of 1.18 to 1.30 at 60° C.;

[0013] Step S2, drying, grinding into fine powder, adding appropriate amount of dextrin, and mixing;

[0014] Step S3, granulating with ethanol having a mass concentration of 90%, and drying to obtain a finished Chinese medicine preparation.

[0015] The fourth aspect of the present invention is to provide a use of the traditional Chinese medicine composition described in the first aspect in treating inflammation.

[0016] The fifth aspect of the present invention is to provide a use of the traditional Chinese medicine preparation described in the second aspect in treating inflammation.

[0017] Compared with the prior art, the Chinese medicine composition, Chinese medicine preparation, preparation method and application thereof provided by the present invention with the efficacy of nourishing the vital energy and strengthening the foundation have the following beneficial effects:

[0018] One, the Chinese medicine composition with the effect of strengthening the original body and consolidating the foundation of the present invention, with Codonopsis pilosula, Poria cocos, and Atractylodes macrocephala as monarch medicine, play the effect of invigorating qi, strengthening the spleen and eliminating dampness, tangerine peel, lotus seed, patchouli, Amomum villosum, costus root, and clove as ministerial medicine, invigorating the spleen and eliminating dampness, stopping diarrhea, and helping the effect of the monarch medicine, scorched hawthorn, Shenqu, and malt as adjuvant medicine, digesting food, invigorating the spleen and promoting qi circulation, and roasted liquorice harmonizes various medicines, and has the merit of invigorating the spleen and replenishing qi concurrently. Therefore, the Chinese medicine composition with the effect of strengthening the original body and consolidating the foundation of the present invention, each drug compatibility is appropriate, and together they have the merit of invigorating the spleen and eliminating dampness, invigorating the spleen and replenishing qi, can effectively improve the body's immune function, and has a positive therapeutic effect in treating inflammation.

[0019] 2. The preparation method of the Chinese medicine preparation with the effect of nourishing the essence and strengthening the foundation of the present invention is to soak, decoct, filter and concentrate the various components of the Chinese medicine composition to make an extract, and then granulate to obtain the finished Chinese medicine preparation granules. The effective ingredients of each medicine can be fully utilized, thereby improving the therapeutic effect of the Chinese medicine preparation. DETAILED DESCRIPTION

[0020] In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present invention and to make the above-mentioned objects, features and advantages of the present invention more obvious and understandable, the specific implementation methods of the present invention are further described below.

[0021] The endpoints of the ranges and any values ​​disclosed herein are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoints of each range, the endpoints of each range and individual point values, and the individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed herein.

[0022] The Chinese medicine composition with the effect of strengthening the body and nourishing the vital energy of the present invention comprises the following ingredients in parts by weight:

[0023] 26-35 parts of Codonopsis pilosula, 12-20 parts of Atractylodes macrocephala, 12-18 parts of Poria cocos, 10-15 parts of dried tangerine peel, 7-12 parts of Pinellia ternata, 3-8 parts of roasted liquorice root, 25-33 parts of charred hawthorn, 16-23 parts of charred Shenqu, 8-15 parts of charred malt, 3-7 parts of costus root, 10-17 parts of patchouli, 2-5 parts of cloves, 9-15 parts of lotus seeds, and 6-12 parts of Amomum villosum.

[0024] The medicinal properties and effects of each drug ingredient are as follows:

[0025] Codonopsis: sweet, neutral. Enters the spleen and lung meridians, strengthens the spleen and lungs, nourishes blood and produces body fluids. It is used for spleen and lung qi deficiency, poor appetite and fatigue, cough and asthma, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to loss of body fluids, and internal heat and thirst.

[0026] Poria: Sweet, mild, and neutral. It enters the Heart, Lung, Spleen, and Kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It is used for edema, oliguria, phlegm and fluid retention, dizziness and palpitations, spleen deficiency, poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0027] Tangerine peel: Bitter, pungent, and warm. Enters the Lung and Spleen meridians. Regulates Qi and strengthens the spleen, dissipates dampness and resolves phlegm. Used for abdominal distension, loss of appetite, vomiting, diarrhea, and cough with excessive phlegm.

[0028] Pinellia: Pungent and warm. Enters the spleen, stomach, and lung meridians. It dries dampness and resolves phlegm, relieves adverse reactions and stops vomiting, and dissipates lumps and resolves nodules. It is used for damp phlegm, cold phlegm, cough, asthma, excessive phlegm, phlegm-induced dizziness and palpitations, dizziness due to phlegm, headache, vomiting and nausea, chest and abdominal distension, and plum pit qi. It is also used externally for carbuncles, swellings, and phlegm nodules.

[0029] Roasted Licorice: Sweet, neutral. Entries the Heart, Lung, Spleen, and Stomach meridians. Tonifies the spleen and stomach, replenishes Qi and restores pulses. Used for spleen and stomach deficiency, fatigue, palpitations, and irregular pulses.

[0030] Scorched Hawthorn: Sour, sweet, and slightly warm. It enters the spleen, stomach, and liver meridians. It helps digestion and strengthens the stomach, promotes qi and dissipates blood stasis, clears turbidity, and reduces lipids. Scorched Hawthorn enhances its digestive and stagnant properties. It is used for meat stagnation and diarrhea.

[0031] Scorched Shenqu: Scorched Malt: Sweet, neutral. Enters the spleen and stomach meridians. Promotes qi and aids digestion, strengthens the spleen and stimulates appetite, promotes lactation and relieves bloating. Used for indigestion, abdominal distension and pain, spleen deficiency and poor appetite, milk stagnation, and breast pain.

[0032] Costus root: Pungent, bitter, and warm. It enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It promotes qi circulation and relieves pain, strengthens the spleen, and aids digestion. It is used for chest, flank, and abdominal distension and pain, heaviness after diarrhea, indigestion, and loss of appetite. Simmered costus root strengthens the intestines and relieves diarrhea. It is used for abdominal pain caused by diarrhea.

[0033] Patchouli: Pungent, slightly warm. It enters the spleen, stomach, and lung meridians. Its aromatic properties clear turbidity, soothe the stomach and stop vomiting, and relieve heatstroke. It is used for dampness and turbidity blocking the middle part of the body, abdominal distension and vomiting, symptoms of dampness and summer heat, the initial onset of damp-heat syndrome, fever and fatigue, chest tightness and discomfort, cold-dampness and summer heat retention, abdominal pain, vomiting and diarrhea, and sinusitis and headache.

[0034] Clove: Pungent and warming. It enters the spleen, stomach, lung, and kidney meridians, warming the middle and relieving adverse reactions, tonifying the kidneys and supporting yang. It is used for spleen and stomach deficiency and cold, hiccups and vomiting, loss of appetite, vomiting and diarrhea, cold pain in the heart and abdomen, and impotence due to kidney deficiency.

[0035] Lotus seeds: Sweet, astringent, neutral. Enters the spleen, kidney, and heart meridians. Tonifies the spleen and stops diarrhea, stops leukorrhea, benefits the kidneys, astringes semen, nourishes the heart and calms the mind. Used for spleen deficiency diarrhea, leukorrhea, spermatorrhea, palpitations, and insomnia.

[0036] Amomum villosum: Pungent, warming. Enters the spleen, stomach, and kidney meridians. It eliminates dampness and stimulates appetite, warms the spleen and stops diarrhea, regulates qi and stabilizes pregnancy. It is used for dampness and turbidity blocking the middle abdomen, abdominal distension without hunger, spleen and stomach deficiency and cold, vomiting and diarrhea, nausea and vomiting during pregnancy, and fetal movement disorder.

[0037] The Chinese medicine preparation with the effect of nourishing the vital energy and strengthening the foundation of the present invention comprises a pharmaceutically active ingredient and a pharmaceutically acceptable excipient, wherein the pharmaceutically active ingredient is prepared from the above-mentioned Chinese medicine composition, and the excipient used can be starch, dextrin, lactose, etc.

[0038] The following describes in detail the Chinese medicine composition and Chinese medicine preparation having the effect of strengthening the body and nourishing the vital energy through specific examples.

[0039] Example 1

[0040] A Chinese medicine composition with the effect of nourishing the vital energy and strengthening the body, comprising the following ingredients:

[0041] Codonopsis pilosula 30g, Atractylodes macrocephala 15g, Poria 15g, Tangerine peel 12g, Pinellia 9g, Roasted Licorice 6g, Charred Hawthorn 30g, Charred Shenqu 20g, Charred Malt 10g, Costus root 5g, Patchouli 15g, Clove 3g, Lotus seed 12g, Amomum villosum 9g.

[0042] Example 2

[0043] A Chinese medicine preparation having the effect of strengthening the body, wherein the active ingredient is prepared from the Chinese medicine composition of Example 1, and the preparation method of the Chinese medicine preparation comprises the following steps:

[0044] Step S1, soaking the above thirteen Chinese herbs in 8 times the amount of water for 0.5 hours, decocting twice, the first time for 1.5 hours, and the second time for 1 hour with 6 times the amount of water, combining the decoctions, filtering, and concentrating the filtrate to an extract with a relative density of 1.18 to 1.30 (60° C.);

[0045] Step S2, drying, grinding into fine powder, adding appropriate amount of dextrin, and mixing;

[0046] Step S3: granulating with 90 wt% ethanol, drying, and preparing about 1000 g of a Chinese medicine granule preparation.

[0047] The prepared Chinese medicine preparation granules are packed in bags according to specifications.

[0048] clinical trials

[0049] 1. Research subjects: 80 patients with sepsis hospitalized in the ICU of our hospital from 2018 to 2023 were selected and divided into two groups (observation group and control group) according to different treatment methods, with 40 cases in each group.

[0050] 2. Diagnostic criteria:

[0051] Inclusion criteria: (1) meeting the 2016 Sepsis 3.0 definition; (2) complete clinical data; (3) informed consent from patients and their families.

[0052] Exclusion criteria: (1) multiple organ dysfunction syndrome (MODS) at admission; (2) combined with malignant tumors; (3) accompanied by blood system diseases; (4) combined with heart failure; (5) allergic to study drugs, etc.

[0053] The observation group included 22 males and 21 females; aged 35 to 69 years, with an average age of (51.44±5.10) years; the causes of disease were pulmonary infection in 17 cases, acute pancreatitis in 15 cases, abdominal infection in 6 cases, and other in 5 cases.

[0054] The control group included 23 males and 20 females, aged 34 to 68 years (mean age: (51.30±5.47) years). There were 18 cases of pulmonary infection, 16 cases of acute pancreatitis, 7 cases of abdominal infection, and 2 cases of other diseases. There were no significant differences in the data between the groups (P>0.05).

[0055] 3. Treatment methods:

[0056] After admission, both groups received routine treatment including fluid resuscitation, nutritional support, and anti-infection. Meanwhile, the observation group took one bag of this product (10 g per bag) orally three times a day for two weeks.

[0057] 4. Observation indicators:

[0058] (1) Treatment effect. Evaluation is based on the improvement of laboratory indicators, vital signs, etc. Markedly effective: Inflammatory factors and other examination indicators are within the normal range, and vital signs are stable; Effective: All examination indicators and vital signs are significantly improved;

[0059] (2) Inflammatory indicators. Before and after treatment, blood samples were collected to measure interleukin-6 (IL-6) and procalcitonin (PCT) in both groups.

[0060] (3) Health level. The acute physiology and chronic health evaluation (APACHE II) score was used to evaluate health status before and after treatment. It consists of three parts: acute physiology, chronic health, and age. The total score is 71 points. The lower the score, the better the health status.

[0061] Statistical methods SPSS 20.0 was used to analyze the data. Measurement data were expressed as (xˉ±s), and inter-group and intra-group comparisons were performed using t-test and paired t-test, respectively. Number of cases (%) was used to represent enumeration data. 2 P < 0.05 was considered statistically significant. The statistical analysis data of each indicator are as follows:

[0062] The statistical analysis of the treatment effects is as follows:

[0063] Group Significantly effective efficient invalid Total efficiency Observation Group 24(60％) 14(35％) 2(5％) 95％ control group 20(50％) 12(30％) 8(20％) 80％ <![CDATA[X 2 ]]> 4.08 P 0.042

[0064] The statistical analysis of inflammatory indicators is as follows:

[0065]

[0066] The statistical analysis of health levels is as follows:

[0067] Group Before treatment After treatment t p Observation Group 23.54±4.32 9.58±1.67 24.538 ＜0.001 control group 23.89±4.21 11.35±1.68 21.349 ＜0.001 <![CDATA[X 2 ]]> 1.254 9.548 P 0.153 ＜0.001

[0068] The above data results show that the Chinese medicine preparation of the present invention can improve the patient's health level after oral administration, while improving systemic inflammatory response and enhancing the body's immunity.

[0069] Animal experiments:

[0070] 1. Modeling

[0071] For the ulcerative colitis model, rats were fasted (but not watered) for 24 h the day before sampling. After emptying their feces, they were anesthetized with 10% chloral hydrate (0.3 ml / 100 g) intraperitoneally. TNBS / ethanol solution (100 mg / kg TNBS + 50% ethanol 0.25 ml) was then gently injected into the intestinal cavity of the rat at a depth of about 5-6 cm from the anus using a rubber infusion tube. 1 ml of air was then extracted and injected into the intestinal cavity of the rat again. The rat was kept tilted and inverted for several minutes, and then laid flat to wake up naturally.

[0072] After modeling, 10 rats were selected in each of the control group, model group and experimental group, and 10 rats were selected in the normal group for animal experiments.

[0073] 2. Dosage

[0074] The experimental group used the Chinese medicine preparation granules prepared in Example 2, and the dosage coefficients of normal adults and rats were converted according to the human and rat drug dosage conversion formula: 大鼠 =d 人 *(k 大鼠 / k 人 ), calculate the daily dosage for rats. 大鼠 、k 人 Specifically, the experimental group received a 22 g / kg dose of the drug, administered orally once a day for 21 consecutive days.

[0075] The control group was given sulfasalazine at 0.3 g / kg by oral gavage once a day for 21 consecutive days.

[0076] The normal group and the model group were given equal volumes of sterile water.

[0077] 3. Scoring criteria for histological changes observed under a light microscope included ulceration, inflammation, and fibrosis, with scores of 0, 1, and 2, depending on their presence and severity. Lesion depth (reaching the submucosal layer: 1 point, the muscularis sinister layer: 2 points, and the serosa layer: 3 points) was added together to obtain a total score for statistical analysis. The results were analyzed as follows:

[0078] Analysis of colon histopathological scoring results in model rats

[0079]

[0080] Note: Compared with the model group, *P<0.01

[0081] According to the above pathological scores, it can be seen that the Chinese medicine preparation of the present invention can significantly improve the inflammation score of colon tissue in the rat model.

[0082] 4. Detection of inflammatory factors in rat serum

[0083] The serum of rats in each group was collected to detect the levels of IL-4 and IFN-γ in the serum. The test results are as follows:

[0084] Results of IL-4 and IFN-γ content detection in the serum of rats in each group

[0085]

[0086] Note: Compared with the model group, *P<0.01

[0087] According to the above analysis results, the Chinese medicine preparation of the present invention can improve the inflammatory factors in the blood of ulcerative colitis model mice, reduce pro-inflammatory factors and upregulate anti-inflammatory factors.

[0088] In summary, clinical observations and animal experiments have shown that the Chinese medicine preparation of the present invention can regulate immunity, improve the balance between pro-inflammatory factors and anti-inflammatory factors in the body, achieve the purpose of strengthening the body, and at the same time improve the body's inflammatory response.

[0089] The embodiments of the present invention are described in detail above, but the present invention is not limited to the described embodiments. It is apparent to those skilled in the art that various changes, modifications, substitutions, and variations made to these embodiments without departing from the principles and spirit of the present invention are still within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition having the effect of strengthening the body, characterized in that: The composition comprises the following components by weight: 26-35 parts of Codonopsis pilosula, 12-20 parts of Atractylodes macrocephala, 12-18 parts of Poria cocos, 10-15 parts of dried tangerine peel, 7-12 parts of Pinellia tuber, 3-8 parts of roasted liquorice, 25-33 parts of charred hawthorn, 16-23 parts of charred Shenqu, 8-15 parts of charred malt, 3-7 parts of costusroot, 10-17 parts of patchouli, 2-5 parts of cloves, 9-15 parts of lotus seeds, and 6-12 parts of Amomum villosum.

2. The Chinese medicine composition with the effect of strengthening the body according to claim 1, characterized in that: The composition includes the following components by weight: 30 parts of Codonopsis pilosula, 15 parts of Atractylodes macrocephala, 15 parts of Poria cocos, 12 parts of dried orange peel, 9 parts of Pinellia tuber, 6 parts of roasted Licorice root, 30 parts of charred Crataegus pinnatifida, 20 parts of charred Shenqu, 10 parts of charred malt, 5 parts of costusroot, 15 parts of patchouli, 3 parts of cloves, 12 parts of lotus seeds, and 9 parts of Amomum villosum.

3. A Chinese medicine preparation having the effect of strengthening the body, characterized in that: It comprises active pharmaceutical ingredients and pharmaceutically acceptable excipients, wherein the active pharmaceutical ingredients are prepared from the traditional Chinese medicine composition according to claim 1.

4. A method for preparing a Chinese medicine preparation having the effect of strengthening the body, characterized in that: The Chinese medicine composition according to claim 1 is used, and the preparation method comprises the following steps: Step S1, soaking the Chinese medicine composition in an appropriate amount of water, decocting, filtering and concentrating to obtain an extract with a relative density of 1.18 to 1.30 at 60° C.; Step S2, drying, crushing into fine powder, adding appropriate amount of dextrin, and mixing; Step S3, granulating with ethanol having a mass concentration of 90%, and drying to obtain a finished Chinese medicine preparation.

5. Use of the Chinese medicinal composition with the effect of strengthening the body as claimed in claim 1 in treating inflammation.

6. Use of the Chinese medicinal preparation with the effect of strengthening the body as claimed in claim 3 in treating inflammation.

Images