Traditional Chinese medicine composition for treating chronic enteritis and preparation method thereof

Abstract

The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 13 to 17 parts of fried hyacinth beans, 13 to 17 parts of fried rhizoma atractylodis macrocephalae, 8 to 12 parts of fructus tsaoko, 8 to 12 parts of rhizoma galangae, 8 to 12 parts of medicated leaven, 8 to 12 parts of pericarpium citri reticulatae viride, 3 to 7 parts of betel nuts and 3 to 7 parts of rhizoma zingiberis. The traditional Chinese medicine composition disclosed by the invention takes effect quickly and has a remarkable curative effect aiming at the symptoms of deficiency-cold in spleen and stomach and qi stagnation and dampness obstruction, overcomes the defects of biased drug properties or single effect in the prior art, has small side effects and high safety, and provides a more excellent treatment choice for clinical treatment of chronic enteritis.

Description

TECHNICAL FIELD

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

[0002] Chronic enteritis is a common digestive system disease, and its main symptoms are long-term or recurrent abdominal pain, diarrhea, and abnormal stool. Its causes are complex, and the disease is prolonged and not cured, which seriously affects the quality of life of patients.

[0003] At present, the treatment of chronic enteritis mainly includes two ways of western medicine and traditional Chinese medicine. Western medicine treatment often uses antibiotics (such as for bacterial infection), intestinal mucosa protective agents, microecological preparations, and antispasmodic analgesics. These methods can relieve symptoms to some extent, but have problems such as treating symptoms but not the root cause, easy to produce drug resistance, obvious side effects (such as disturbing intestinal flora), and limited effect on non-infectious and functional chronic enteritis.

[0004] In the theory of traditional Chinese medicine, chronic enteritis is mostly attributed to diarrhea, chronic dysentery, and abdominal pain. It is generally believed that the core pathogenesis is deficiency of the spleen and stomach, combined with pathological factors such as dampness, qi stagnation, and food accumulation. The spleen and stomach are located in the middle, and are responsible for transportation and transformation. If the yang qi is weak, the transportation and transformation will be abnormal, cold will be generated from the middle, water and dampness will be retained inside, and clear qi will not rise, thereby causing abdominal pain and diarrhea. Therefore, the basic principle of traditional Chinese medicine treatment is to warm the middle, invigorate the spleen, and eliminate dampness to stop diarrhea.

[0005] There are many traditional Chinese medicine compounds for treating spleen and stomach cold type diarrhea in the prior art, such as the classic prescription Fuzili Zhongwan Pill and Shenling Baizhu Powder. These prescriptions have certain effects, but still have some deficiencies. For example, the aconite in Fuzili Zhongwan Pill is a very hot product, and is not suitable for long-term use; many prescriptions focus on warming and tonifying, or tonifying qi and invigorating the spleen, or eliminating dampness, and it is difficult to fully consider the common complex pathogenesis of spleen and stomach cold accompanied by qi stagnation and dampness retention, resulting in slow or difficult to consolidate the curative effect.

[0006] Therefore, there is an urgent need in the art for a traditional Chinese medicine composition with more appropriate compatibility, which can synergistically play the comprehensive effects of warming the middle and dispelling cold, invigorating the spleen and drying dampness, and promoting qi and eliminating accumulation, and has small side effects, strong targeting, and significant effect, to solve the above-mentioned defects in the prior art, and better meet the needs of clinical treatment of spleen and stomach cold type chronic enteritis with qi stagnation and dampness retention. SUMMARY

[0007] In view of the deficiencies of the prior art, the present application provides a traditional Chinese medicine composition for treating chronic enteritis and a preparation method thereof. The traditional Chinese medicine composition has the effects of warming the middle and invigorating the spleen, and promoting qi and stopping diarrhea for abdominal pain and diarrhea caused by chronic enteritis due to deficiency of the spleen and stomach.

[0008] The application provides a traditional Chinese medicine composition for treating chronic enteritis, which is prepared from the following raw materials in parts by weight: fried lablab 13-17 parts, fried atractylodes 13-17 parts, Amomum tsao-ko 8-12 parts, high-quality ginger 8-12 parts, Shenqu 8-12 parts, pericarpium citri reticulatae viride 8-12 parts, areca nut 3-7 parts and dried ginger 3-7 parts, wherein the parts by weight are based on the dry weight of the raw medicinal materials.

[0009] Preferably, the traditional Chinese medicine composition for treating chronic enteritis is prepared from the following raw materials in parts by weight: fried lablab 15 parts, fried atractylodes 15 parts, Amomum tsao-ko 10 parts, high-quality ginger 10 parts, Shenqu 10 parts, pericarpium citri reticulatae viride 10 parts, areca nut 5 parts and dried ginger 5 parts, wherein the parts by weight are based on the dry weight of the raw medicinal materials.

[0010] Preferably, the traditional Chinese medicine composition is prepared into an oral preparation.

[0011] Preferably, the oral preparation is one of water decoction, oral liquid, granules, tablets, capsules and pills.

[0012] The preparation method of the traditional Chinese medicine composition comprises the following steps: weighing the raw materials according to the proportion by weight, adding 3-5 times the volume of water of the raw materials, boiling for 30-40 minutes on a small fire, filtering to obtain medicinal liquid, storing the medicinal liquid in another container, adding 3-5 times the volume of water of the raw materials again, boiling for the second time according to the foregoing method, filtering to obtain medicinal liquid, mixing the medicinal liquid obtained in the first and second times, and continuing to heat and concentrate until the medicinal liquid contains 1 g / mL of raw medicinal materials.

[0013] The medicinal mechanism of the medicinal raw materials used in the application is as follows:

[0014] Fried lablab: sweet and slightly warm, meridian-entering spleen and stomach. Fried lablab can enhance the function of strengthening the spleen and stopping diarrhea, and has the effects of strengthening the spleen, removing dampness, harmonizing the center, and stopping diarrhea.

[0015] Fried atractylodes: sweet and bitter and warm, meridian-entering spleen and stomach. Fried atractylodes can enhance the function of strengthening the spleen and stopping diarrhea, and has the effects of strengthening the spleen, tonifying qi, drying dampness and removing water.

[0016] Amomum tsao-ko: bitter and pungent and warm, meridian-entering liver, gallbladder and stomach. Amomum tsao-ko is good at dispersing liver qi and breaking up stagnation, and has the effects of drying dampness and removing cold, removing phlegm and stopping malaria, and digesting food.

[0017] High-quality ginger: pungent and hot, meridian-entering spleen and stomach. High-quality ginger has the effects of warming the stomach and dispelling cold, and digesting food and stopping pain.

[0018] Shenqu: sweet and pungent and warm, meridian-entering spleen and stomach. Shenqu has the effects of strengthening the spleen and stomach, and digesting food and removing stagnation.

[0019] Pericarpium citri reticulatae viride: bitter and pungent and warm, meridian-entering liver, gallbladder and stomach. Pericarpium citri reticulatae viride has the effects of dispersing liver qi and breaking up stagnation, and digesting food and removing stagnation.

[0020] Betel nut: bitter-warm, return to stomach, large intestine. Can move gas and eliminate accumulation, benefit water and remove dampness.

[0021] The traditional Chinese medicine composition of the present application strictly follows the theory of monarch, minister and assistant of traditional Chinese medicine, and is matched according to the core pathogenesis of spleen and stomach deficiency, cold and dampness stagnation:

[0022] Monarch: Amomum tsao-ko and Alpinia officinarum are the monarch. Amomum tsao-ko is pungent and strong, and is good at drying dampness and warming middle, and removing cold and dampness in middle. Alpinia officinarum is pungent and hot, and is good at warming stomach and dispelling cold. The two together directly hit the disease, and are good at removing cold and dampness.

[0023] Minister: fried Atractylodes and fried lentil are the minister. Fried Atractylodes is good at tonifying qi and spleen, drying dampness and benefiting water, and fried lentil is good at tonifying spleen, removing dampness and stopping diarrhea. On the basis of removing evil by monarch, the two can support the healthy qi and enhance the function of spleen and stomach, so as to fundamentally eliminate the source of water and dampness, and embody the principle of treating disease from the root.

[0024] Assistant: Betel nut and medicated leaven are the assistant. Medicated leaven is good at digesting food and stomach, and resolving food accumulation. Betel nut is good at moving qi, eliminating accumulation, benefiting water and removing dampness. The two are good at removing qi stagnation and food accumulation, dredging qi movement in middle, eliminating fullness, and making the whole prescription tonifying without stagnation, and dredging without deficiency, which clears the obstacles for the effect of monarch and minister.

[0025] Agent: dried ginger and pericarpium citri reticulatae are the agent. Dried ginger is good at warming middle and recovering yang, and assists monarch to enhance the effect of warming middle and dispelling cold. Pericarpium citri reticulatae is good at moving qi and breaking knot, and its pungent and dispersing nature can lead other medicines into liver and spleen, and is good at dredging qi movement, preventing tonifying medicine from being greasy, and playing the role of regulating medicines.

[0026] The matching principle of the present application is that Amomum tsao-ko and Alpinia officinarum are the core of removing evil, fried Atractylodes and fried lentil are the basis of supporting healthy qi, betel nut and medicated leaven are the bridge of dredging, and dried ginger and pericarpium citri reticulatae are the pivot of cooperation. The whole prescription can disperse cold evil, tonify spleen qi, remove dampness and dredge qi movement, so as to stop abdominal pain and cure diarrhea.

[0027] The beneficial effects of the present application are:

[0028] The traditional Chinese medicine composition of the present application is good at treating the syndrome of spleen and stomach deficiency, qi stagnation and dampness obstruction, and has rapid effect and remarkable curative effect, and overcomes the defects of existing technology, such as partial medicine property and single effect, and has small side effect and high safety, and provides a more superior treatment choice for the clinical treatment of chronic enteritis. DETAILED DESCRIPTION

[0029] The following examples further illustrate the present application, but should not be construed as limiting the present application. Modifications or replacements of the method, steps or conditions of the present application without departing from the spirit and essence of the present application all belong to the scope of the present application.

[0030] Example 1: Traditional Chinese medicine composition for treating chronic enteritis

[0031] The following raw medicinal materials were weighed by dry weight: fried lentils 15 g, fried atractylodes 15 g, cardamom 10 g, galangal 10 g, medicated leaven 10 g, pericarpium citri reticulatae viride 10 g, areca nut 5 g, dried ginger 5 g.

[0032] The following steps were taken: the raw medicinal materials were washed and dried, 5 times the volume of water was added, and it was boiled for 40 minutes on a low fire. The medicinal liquid was filtered and placed in another container for later use. The same process was repeated a second time with 5 times the volume of water. The medicinal liquid was filtered and kept. The two medicinal liquids were mixed and heated to concentrate the medicinal liquid to 1 g / mL.

[0033] Example 2 Chinese medicinal composition for treating chronic enteritis

[0034] The following raw medicinal materials were weighed by dry weight: fried lentils 15 g, fried atractylodes 15 g, cardamom 10 g, galangal 10 g, medicated leaven 10 g, pericarpium citri reticulatae viride 10 g, areca nut 5 g, dried ginger 5 g.

[0035] The following steps were taken: the raw medicinal materials were washed and dried, 5 times the volume of water was added, and it was boiled for 40 minutes on a low fire. The medicinal liquid was filtered and placed in another container for later use. The same process was repeated a second time with 5 times the volume of water. The medicinal liquid was filtered and kept. The two medicinal liquids were mixed and heated to concentrate the medicinal liquid to 1 g / mL.

[0036] Example 3 Chinese medicinal composition for treating chronic enteritis

[0037] The following raw medicinal materials were weighed by dry weight: fried lentils 15 g, fried atractylodes 15 g, cardamom 10 g, galangal 10 g, medicated leaven 10 g, pericarpium citri reticulatae viride 10 g, areca nut 5 g, dried ginger 5 g.

[0038] The following steps were taken: the raw medicinal materials were washed and dried, 5 times the volume of water was added, and it was boiled for 40 minutes on a low fire. The medicinal liquid was filtered and placed in another container for later use. The same process was repeated a second time with 5 times the volume of water. The medicinal liquid was filtered and kept. The two medicinal liquids were mixed and heated to concentrate the medicinal liquid to 1 g / mL.

[0039] Comparative Example Fuzi Lizhong Decoction

[0040] The classic Chinese medicine prescription Fuzili Zhongtang was selected as a comparative example. The following raw medicinal materials were weighed according to dry weight: Fuzi 10 g, Dangshen 20 g, Chao Baizhu 15 g, Ganjiang 10 g, and Zhigancao 10 g. The raw medicinal materials were washed and dried, and then added with water in a volume of 5 times that of the raw medicinal materials. The mixture was boiled for 40 minutes on a low heat, and then filtered to obtain medicinal liquid. The medicinal liquid was stored in another container for standby. Water in a volume of 5 times that of the raw medicinal materials was added again, and the mixture was boiled for the second time according to the foregoing method. The medicinal liquid was filtered and reserved. The medicinal liquids obtained in the first and second times were mixed uniformly, and then continuously heated and concentrated until the raw medicinal material contained in the medicinal liquid was 1 g / mL.

[0041] Experimental Example

[0042] The therapeutic effects of the medicinal composition in Example 1 and Fuzili Zhongtang in the comparative example on intestinal inflammation mice were investigated, and the experimental procedure was as follows:

[0043] 1. Experimental animals: 50 ICR mice, male, weighing 18-22 g, were adaptively fed for one week. The mice were randomly divided into 5 groups: a blank control group, an Example 1 group, a comparative example group, a model group, and a western medicine control group, 10 mice in each group.

[0044] 2. Modeling method

[0045] The raw medicinal material of sennae folium was weighed, and then decocted with water to prepare a raw medicinal water decoction with a concentration of 0.1 g / mL (10%) for standby. The Example 1 group, the comparative example group, the model group, and the western medicine control group were subjected to gavage at a volume of 0.1 mL / 10 g of body weight once a day for 14 days. The blank control group was subjected to gavage with physiological saline at the same volume once a day for 14 days.

[0046] The distilled water was stored in a 4°C refrigerator for at least 12 hours, and then freshly taken before each gavage to keep low temperature. The Example 1 group, the comparative example group, the model group, and the western medicine control group were subjected to gavage at a volume of 0.1 mL / 10 g of body weight once every other day for 14 days. The blank control group was subjected to gavage with physiological saline at 37°C at the same volume once every other day for 14 days.

[0047] In this way, a mouse model similar to human diseases with main manifestations of diarrhea, weight loss, cold and huddling, and abdominal distension was obtained.

[0048] 3. Experimental reagents:

[0049] The medicinal liquid of Example 1;

[0050] The medicinal liquid of the comparative example;

[0051] Loperamide (Xi'an Yangsen Pharmaceutical Co., Ltd.) was prepared into a suspension with a concentration of 0.3 mg / mL as the western medicine control group mouse test drug for standby.

[0052] 4. Experimental process

[0053] On the 7th to 14th day of mouse modeling, the administration was as shown in Table 1:

[0054] Table 1 Summary of mouse administration

[0055]

[0056] After the last administration, the mice in each group were fasted for 24 hours without water. The serum was taken to detect TNF-α, IL-1β, IL-6 indicators; each mouse was given Indian ink suspension by gavage, and 30 minutes later, it was executed, and the percentage of ink advance length to the whole length of small intestine (small intestine advance rate) was calculated. The test results are shown in Table 2:

[0057] Table 2 Test data of mice in each group

[0058]

[0059] As can be seen from the data in Table 2, there is a significant difference between the model group and the blank group, which indicates that the modeling is successful.

[0060] Analysis of three inflammation indicators (TNF-α, IL-1β, IL-6): the model group has the highest value, which indicates that the modeling successfully triggers a strong intestinal inflammatory response; the inflammation factor level of the western medicine control group has no statistical difference with the model group, and even IL-6 is higher. This reflects its simple antidiarrheal, not anti-inflammatory characteristics, and even may aggravate local inflammation due to content retention; the three inflammation indicators of the comparative example group are significantly lower than those of the model group, which proves that the method of warming middle and invigorating spleen of Fuzi Lizhong Decoction has a certain anti-inflammatory effect; and the three inflammation indicators of Example 1 group are the lowest among all treatment groups, and there is a significant difference with the comparative example group and the western medicine control group. This strongly proves that the formula of the application not only inherits the warming and anti-inflammatory effect of Fuzi Lizhong Decoction, but also produces a stronger anti-inflammatory effect due to its unique compatibility (such as grass fruit, areca nut, etc.), far exceeding the western medicine which is simply antidiarrheal.

[0061] Analysis of small intestine advance rate: the model group has the highest advance rate, which shows that the intestinal peristalsis is hyperactive and diarrhea; the advance rate of the western medicine control group is excessively inhibited, which is significantly lower than even the blank control group. This simulates its clinical side effect of causing abdominal distension and constipation, and reflects the drawbacks of antidiarrheal retention; the advance rate of the comparative example group is lower than that of the model group, but is still significantly higher than that of the blank group, which indicates that its function of restoring normal intestinal motility is limited; and the advance rate of Example 1 group is restored to the ideal level which has no significant difference with the blank control group, which indicates that the qi-moving drugs (pericarpium citri reticulatae viride, areca nut) in the prescription of the application are compatible with the spleen-invigorating and antidiarrheal drugs, which realizes the effect of antidiarrheal without retention, effectively stopping diarrhea and avoiding the problems of intestinal motility inhibition caused by western medicine and incomplete recovery of positive drugs, which is significantly better than the western medicine control group and the comparative example group.

Claims

1. A traditional Chinese medicine composition for treating chronic enteritis, characterized in that, The traditional Chinese medicine composition is made of the following raw materials in parts by weight: fried lablab 13-17 parts, fried atractylodes 13-17 parts, cardamom 8-12 parts, galangal 8-12 parts, Chinese medicinal leaven 8-12 parts, pericarpium citri reticulatae viride 8-12 parts, areca nut 3-7 parts, and dried ginger 3-7 parts, wherein the parts by weight are based on the dry weight of the raw medicinal materials.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made of the following raw materials in parts by weight: fried lablab 15 parts, fried atractylodes 15 parts, cardamom 10 parts, galangal 10 parts, Chinese medicinal leaven 10 parts, pericarpium citri reticulatae viride 10 parts, areca nut 5 parts, and dried ginger 5 parts, wherein the parts by weight are based on the dry weight of the raw medicinal materials.

3. The traditional Chinese medicine composition according to any one of claims 1-2, characterized in that: The traditional Chinese medicine composition is made into an oral preparation.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The oral preparation is one of water decoction, oral liquid, granules, tablets, capsules, and pills.

5. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The method comprises the following steps: The raw materials are weighed according to the proportion by weight, water with a volume of 3-5 times that of the raw materials is added, and the mixture is boiled for 30-40 minutes on a small fire. The medicinal liquid is filtered and reserved in another container. Water with a volume of 3-5 times that of the raw materials is added again, and the mixture is boiled for the second time according to the previous method. The medicinal liquid is filtered and reserved. The medicinal liquids obtained in the first and second times are mixed uniformly, and the mixture is continuously heated and concentrated until the content of the raw medicinal materials in the medicinal liquid is 1 g / mL.

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