A Chinese medicine composition for preventing or treating constipation and its preparation method and application

Abstract

The invention provides a Chinese medicine composition for preventing or treating constipation, and a preparation method and application thereof. The Chinese medicine composition comprises the following raw materials in parts by weight: 25-45 parts of Codonopsis pilosula, 12-25 parts of Atractylodes macrocephala, 18-22 parts of Poria cocos, 10-18 parts of Radix Sanguisorbae officinalis, 5-12 parts of Aquilaria sinensis, 8-15 parts of Linderae scutellariae, 5-10 parts of Scrophularia ningpoensis, 3-8 parts of Ophiopogon japonicus, 2-6 parts of Radix Rehmanniae, 2-8 parts of Radix Angelicae Pubescentis, 3-9 parts of Rhubarb, 1-5 parts of Immature Citrus aurantium, 2-7 parts of Magnolia officinalis, 1-5 parts of Sodium Sulfate, 2-8 parts of Aucklandia lappa, 2-7 parts of Radix Glycyrrhizae Preparata and 2-6 parts of Radix Bupleuri. The active ingredients in the medicine are prepared and extracted in steps according to the compatibility of monarch medicine, ministerial medicine and adjuvant medicine, so that the drug effect can be more fully exerted, the microecological environment inside the intestine can be effectively improved, and the occurrence of constipation can be prevented. After administration, the constipation symptoms are significantly improved, the number of defecation is increased, the stool shape is normal, the degree of effort in defecation is reduced, and the symptoms of real constipation type constipation are effectively prevented or treated.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for preventing or treating constipation, and a preparation method and application thereof. Background Art

[0002] Traditional Chinese medicine divides constipation into two types: excess constipation and deficiency constipation. Excess constipation includes heat accumulation in the stomach and intestines, qi stagnation, and yin-cold stagnation. Among them, the symptoms of heat accumulation in the stomach and intestines are thirst, frequent drinking, and constipation; the symptoms of qi stagnation are chest and flank distension and dry stool; the symptoms of yin-cold stagnation are cold limbs and dry stool; deficiency constipation includes qi deficiency constipation, blood deficiency constipation, and yang deficiency constipation, including dry or not dry stool, lack of strength to defecate despite the urge to defecate, sweating, shortness of breath, fatigue, limb fatigue, laziness, etc.

[0003] Constipation is a common digestive system disease, characterized by symptoms such as decreased bowel movement, labored defecation, hard or ball-shaped stool, and a feeling of incomplete defecation. Actual constipation is one type of constipation, which is mainly caused by slower intestinal motility, stool staying in the intestine for too long, and excessive water absorption. Treatments for actual constipation include drug therapy and non-drug therapy, among which drug therapy mainly uses Chinese or Western medicine. Western medicine has many drugs for treating constipation, which take effect relatively quickly and can quickly relieve constipation symptoms. Western medicine has relatively large side effects in treating constipation, such as drug dependence, intestinal flora imbalance, etc. In addition, the efficacy of Western medicine in treating constipation may be unstable and easily affected by factors such as diet and lifestyle.

[0004] Traditional Chinese medicine has unique advantages in treating constipation, mainly because it has an overall regulatory effect, can treat the cause of the disease, and has the advantage of fewer side effects. In terms of Chinese medicine compositions, many prescriptions have been used to treat constipation to enhance intestinal motility, soften stool, and relieve constipation symptoms. Although some Chinese medicine compositions have been used to treat constipation, there are still some problems. There are differences in the conditions and constitutions of different patients, and the forms of real and virtual constipation are different. Different types of constipation need to be treated according to syndrome differentiation. In addition, the composition of Chinese medicine is relatively complex, and there may be interactions between different drugs. Improper combination will lead to unstable efficacy. Summary of the invention

[0005] In view of this, the present invention provides a Chinese medicine composition for preventing or treating constipation and a preparation method and application thereof to solve the above problems.

[0006] The technical scheme of the present invention is achieved as follows: A Chinese medicine composition for preventing or treating constipation comprises the following raw materials in parts by weight: 25-45 parts of Codonopsis pilosula, 12-25 parts of Atractylodes macrocephala, 18-22 parts of Poria cocos, 10-18 parts of fried Sanguisorba officinalis, 5-12 parts of Aquilaria woodii, 8-15 parts of Linderae scutellariae, 5-10 parts of Scrophularia ningpoensis, 3-8 parts of Ophiopogon japonicus, 2-6 parts of Rehmannia root, 2-8 parts of Shenqu, 3-9 parts of Rhubarb, 1-5 parts of Citrus aurantium, 2-7 parts of Magnolia officinalis, 1-5 parts of Sodium sulfate, 2-8 parts of Aucklandia lappa, 2-7 parts of Radix Glycyrrhizae roasted, and 2-6 parts of Bupleurum chinense.

[0007] Furthermore, a Chinese medicine composition for preventing or treating constipation comprises the following raw materials in parts by weight: 30-40 parts of Codonopsis pilosula, 15-20 parts of Atractylodes macrocephala, 19-21 parts of Poria cocos, 15-17 parts of Sanguisorba officinalis, 7-10 parts of Aquilaria woodii, 10-13 parts of Linderae scutellariae, 6-8 parts of Scrophularia ningpoensis, 4-6 parts of Ophiopogon japonicus, 3-5 parts of Rehmannia root, 4-6 parts of Shenqu, 4-8 parts of Rhubarb, 3-5 parts of Citrus aurantium, 3-5 parts of Magnolia officinalis, 2-4 parts of Sodium sulfate, 4-6 parts of Costus root, 3-5 parts of Radix Glycyrrhizae, and 3-5 parts of Bupleurum chinense.

[0008] Further, it includes the following raw materials in parts by weight: 35 parts of Codonopsis pilosula, 18 parts of Atractylodes macrocephala, 20 parts of Poria cocos, 16 parts of fried Sanguisorba officinalis, 8 parts of Aquilaria woodii, 12 parts of Linderae scutellariae, 7 parts of Scrophularia ningpoensis, 5 parts of Ophiopogon japonicus, 4 parts of Rehmannia root, 5 parts of Shenqu, 6 parts of Rhubarb, 4 parts of Citrus aurantium, 4 parts of Magnolia officinalis, 3 parts of Sodium sulfate, 5 parts of Costus root, 4 parts of Radix Glycyrrhizae uralensis, and 4 parts of Bupleurum chinense.

[0009] Furthermore, the raw materials are added with pharmaceutically acceptable excipients to prepare any dosage form.

[0010] Furthermore, a method for preparing a Chinese medicine composition for preventing or treating constipation comprises the following steps:

[0011] S1. According to the formula, weigh the raw materials of Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Sanguisorba officinalis, Aquilaria sinensis, and Linderae strychnifolia, dry them, crush them, and sieve them to obtain coarse powder I for later use; take Scrophularia ningpoensis, Ophiopogon japonicus, Rehmannia glutinosa, and Shenqu, dry them, crush them, and sieve them to obtain coarse powder II;

[0012] S2, mixing the above coarse powder I and coarse powder II, adding purified water, ultrasonically extracting for 2-4 times, each time for 40-60 min, filtering, and combining to obtain filtrate I;

[0013] S3, taking rhubarb, immature bitter orange, magnolia bark, sodium sulfate, costus root, licorice root, and bupleurum, freeze-dried at -20°C or below, crushed, put into an extraction tank, and then extracted with anhydrous ethanol for 3-5 hours, filtered after extraction, and obtained filtrate II;

[0014] S4. Mix the filtrate I and the filtrate II, adjust the pH to 5-7, and concentrate to a relative density of 1.10-1.2 to obtain a fluid extract.

[0015] Furthermore, the particle size of the coarse powder I and the coarse powder II in S1 is 850±70 μm.

[0016] Furthermore, the mass volume g / mL of the mixture of coarse powder I and coarse powder II and purified water in S2 is 4-8:20.

[0017] Furthermore, the power of ultrasonic extraction in S2 is 300-400W, and the ultrasonic frequency is 20-100KHz.

[0018] Furthermore, a Chinese medicine composition for preventing or treating constipation is used in the preparation of a medicine for preventing or treating constipation.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The Chinese medicine composition of the present invention is a clinical experience prescription, wherein Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, fried Sanguisorba officinalis, Aquilaria sinensis, and Linderae radix are monarch drugs, which have the effects of tonifying the middle qi, strengthening the spleen and benefiting the lungs, astringing and stopping bleeding, and Scrophularia ningpoensis, Radix Ophiopogonis, Radix Rehmanniae, and Radix Angelicae Sinensis are minister drugs, which can enhance the effect of the monarch drug, and have the effects of nourishing yin and promoting body fluid, moistening dryness and relieving constipation, and promoting digestion and middle effects. The monarch drug can be assisted in treating the symptoms of spleen and stomach weakness, insufficient lung qi, and the symptoms of constipation and loss of appetite caused by the disease can be alleviated; Rhubarb, Fructus Aurantii Immaturus, Magnolia officinalis, Sodium Sulfate, and Radix Aucklandiae are mutually adjuvant drugs, which have the effects of clearing away heat and purging fire, promoting qi and relieving constipation, and promoting digestion and removing accumulation, and can assist the monarch drug and minister drug in treating febrile diseases, and Radix Glycyrrhizae Preparata has the effect of harmonizing various drugs, can enhance the efficacy, make the prescription more peaceful as a whole, and reduce the occurrence of adverse reactions. Bupleurum has the effect of soothing the liver and relieving depression, can enhance the efficacy of the main and auxiliary drugs, can enhance the qi-promoting effect of agarwood and lindera, and relieve symptoms such as abdominal distension and abdominal pain caused by constipation. The prescription of the present invention can be used to treat symptoms such as gastrointestinal heat accumulation, qi stagnation, and lung qi deficiency, and can relieve symptoms such as constipation and loss of appetite caused by diseases.

[0021] According to the compatibility of the main drug, the auxiliary drug and the adjuvant drug, the active ingredients in the drug are prepared and extracted step by step, and then mixed and compounded. Animal experiments have confirmed that the Chinese medicine composition of the present invention has the functions of increasing gastrointestinal motility and moistening the intestines and relieving constipation, and can significantly improve the constipation symptoms of animal models of gastrointestinal heat accumulation, qi stagnation and yin-cold stagnation; clinical experiments have confirmed that the Chinese medicine composition of the present invention can significantly reduce the constipation symptoms caused by gastrointestinal heat accumulation, qi stagnation and yin-cold stagnation, and relieve gastrointestinal discomfort. DETAILED DESCRIPTION

[0022] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0023] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0024] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0025] The following introduces the basic information of the main raw materials based on the "Chinese Pharmacopoeia", "Chinese Materia Medica Dictionary" and "Chinese Herbal Medicine".

[0026] Codonopsis: Nature and flavor: sweet, neutral. Enters the spleen and lung meridians. Functions and indications: tonifies the middle and replenishes qi, strengthens the spleen and benefits the lungs. Used for spleen and lung weakness, shortness of breath and palpitations, poor appetite and loose stools, asthenia and cough, internal heat and thirst.

[0027] Atractylodes macrocephala: Nature and flavor: bitter, sweet, warm. Enters the spleen and stomach meridians. Functions and indications: invigorates the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and stabilizes the fetus. Used for spleen deficiency, poor appetite, abdominal distension and diarrhea, phlegm and fluid, dizziness and palpitations, edema, spontaneous sweating, and restless fetus.

[0028] Poria: Nature and flavor: sweet, light, neutral. Enters the heart, lung, spleen, and kidney meridians. Functions and indications: diuresis and dampness removal, spleen-strengthening and heart-calming. Used for edema, oliguria, phlegm and fluid, palpitations, spleen deficiency, poor appetite, loose stools, restlessness, palpitations, and insomnia.

[0029] Fried Sanguisorba officinalis: Nature and flavor: bitter, sour, astringent, slightly cold. Enter the liver and large intestine meridians. Functions and indications: cooling blood and stopping bleeding, detoxifying and healing sores. Used for blood in stool, hemorrhoids, bloody diarrhea, metrorrhagia, burns caused by water or fire, carbuncle, sores and poison.

[0030] Agarwood: Nature and flavor: pungent, bitter, slightly warm. Enters the spleen, stomach, and kidney meridians. Functions and indications: promotes qi and relieves pain, warms the middle and stops vomiting, and relieves asthma. Used for chest and abdominal distension and pain, vomiting and hiccups due to stomach cold, and asthma due to kidney deficiency and qi reversal.

[0031] Linderae Root: Nature and flavor: pungent, warm. Enters the lung, spleen, kidney, and bladder meridians. Functions and indications: promotes qi and relieves pain, warms the kidney and dispels cold. Used for chest and abdominal distension and pain, cold hernia and abdominal pain, frequent urination and enuresis.

[0032] Scrophularia: Nature and flavor: sweet, bitter, salty, cold. Enters the lung, stomach, and kidney meridians. Functions and indications: clearing heat and cooling blood, nourishing yin and detoxifying. Used for heat entering the blood, fever toxicity causing spots, febrile disease damaging yin, red tongue and thirst, body fluid damage and constipation, bone steaming and fatigue cough, red eyes and sore throat, scrofula and sputum nodules, carbuncle and sore.

[0033] Ophiopogon japonicus: Nature and flavor: sweet, slightly bitter, slightly cold. Enters the heart, lung, and stomach meridians. Functions and indications: nourishes yin and produces body fluid, moistens the lungs and relieves cough. Used for symptoms such as thirst due to deficiency of lung and stomach yin, dry cough and hemoptysis; palpitations and easy fright due to deficiency of heart yin, and damage to body fluid by heat in the late stage of fever.

[0034] Raw Rehmannia root: Nature and flavor: sweet, bitter, cold. Enters the heart, liver, and kidney meridians. Functions and indications: clears away heat and produces body fluid, cools blood and stops bleeding. Used for hot wind damaging yin, thirst, red tongue, yin deficiency, internal heat, thirst, and excessive drinking.

[0035] Shenqu: Nature and flavor: sweet, pungent, warm. Enters the spleen and stomach meridians. Functions and indications: helps digestion and soothes the stomach. Used for food stagnation syndrome.

[0036] Rhubarb: Nature and flavor: bitter, cold. It enters the spleen, stomach, large intestine, liver, and pericardium meridians. Functions and indications: purging heat and clearing the intestines, cooling blood, removing blood stasis, and dredging the menstrual period. It is used for constipation due to excess heat, abdominal pain due to accumulation, diarrhea, and jaundice due to damp heat.

[0037] Citrus aurantium: Nature and flavor: bitter, pungent, sour, warm. Enters the spleen and stomach meridians. Functions and indications: dispersing qi and eliminating stagnation, resolving phlegm and removing abdominal distension. Used for symptoms such as internal stagnation, fullness and pain, heaviness after diarrhea, constipation, phlegm stagnation and qi obstruction in the chest.

[0038] Magnolia officinalis: Nature and flavor Meridian: bitter, pungent, warm. Enter the spleen, stomach and large intestine meridians Functions and indications: promote qi and dry dampness, eliminate accumulation and relieve asthma. It is used for dampness blocking the middle jiao syndrome, gastrointestinal stagnation, cough, asthma and sputum.

[0039] Glauber's Salt: Nature and flavor: salty, bitter, cold. Enters the stomach and large intestine meridians. Functions and indications: purging heat and relieving constipation, moistening dryness and softening hard masses, clearing away heat and reducing swelling. Used for constipation due to excess heat, dry stool, abdominal distension and pain; external treatment for breast abscess, swollen and painful hemorrhoids, and red and swollen eyes without ulceration.

[0040] Costusroot: Nature and flavor: pungent; bitter; warming. Functions and indications: promoting qi and relieving pain; regulating the middle and relieving stagnation. Mainly used for bloating and distension of the ribs and flanks; abdominal distension and pain; belching, vomiting, diarrhea, and heaviness after dysentery. Used for chest and abdominal distension and pain, heaviness after dysentery, indigestion, and loss of appetite.

[0041] Roasted Licorice: Nature and flavor: sweet; neutral. Targets the heart, lung, spleen, and stomach meridians. Functions and indications: tonifies the spleen and harmonizes the stomach; replenishes qi and restores the pulse. Treats spleen and stomach weakness; fatigue; palpitations; pulse knots and irregularities. Used for spleen and stomach weakness, fatigue, palpitations, and pulse knots and irregularities.

[0042] Bupleurum: Nature and flavor: bitter, pungent, slightly cold. Enters the liver, gallbladder, and lung meridians. Functions and indications: dispels heat, soothes the liver, raises yang, promotes the production of body fluids and quenches thirst. Used for colds and fevers, alternating colds and heats,

[0043] Example 1

[0044] A traditional Chinese medicine composition for preventing or treating constipation comprises the following raw materials by weight: 25 grams of Codonopsis pilosula, 12 grams of Atractylodes macrocephala, 18 grams of Poria cocos, 10 grams of fried Sanguisorba officinalis, 5 grams of Aquilaria sinensis, 8 grams of Linderae scutellariae, 5 grams of Scrophularia ningpoensis, 3 grams of Ophiopogon japonicus, 2 grams of Rehmannia root, 2 grams of Shenqu, 3 grams of Rhubarb, 1 gram of Citrus aurantium, 2 grams of Magnolia officinalis, 1 gram of Sodium Sulfate, 2 grams of Costusroot, 2 grams of Radix Glycyrrhizae Preparata, and 2 grams of Bupleurum chinense.

[0045] Example 2

[0046] A traditional Chinese medicine composition for preventing or treating constipation comprises the following raw materials by weight: 45 grams of Codonopsis pilosula, 25 grams of Atractylodes macrocephala, 22 grams of Poria cocos, 18 grams of fried Sanguisorba officinalis, 12 grams of Aquilaria sinensis, 15 grams of Linderae scutellariae, 10 grams of Scrophularia ningpoensis, 8 grams of Ophiopogon japonicus, 6 grams of Rehmannia root, 8 grams of Shenqu, 9 grams of Rhubarb, 5 grams of Citrus aurantium, 7 grams of Magnolia officinalis, 5 grams of Sodium sulfate, 8 grams of Aucklandia lappa, 7 grams of Radix Glycyrrhizae Preparata, and 6 grams of Bupleurum chinense.

[0047] The above-mentioned examples 1-2 adopt the following preparation method:

[0048] S1. According to the formula, the raw materials of Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Sanguisorba officinalis, Aquilaria sinensis, and Linderae scutellariae are weighed, dried, crushed, and sieved to obtain coarse powder I for later use; Scrophularia ningpoensis, Ophiopogon japonicus, Rehmannia glutinosa, and Shenqu are weighed, dried, crushed, and sieved to obtain coarse powder II; the crushed particle size of the coarse powder I and coarse powder II is 780 μm;

[0049] S2, mixing the above coarse powder I and coarse powder II, adding purified water, the mass volume g / mL of the mixture of coarse powder I and coarse powder II and purified water is 4:20, ultrasonic extraction is performed twice, the power of ultrasonic extraction is 300W, the ultrasonic frequency is 20KHz, each time for 40min, filtering, and combining to obtain filtrate I;

[0050] S3, take rhubarb, immature bitter orange, magnolia bark, mirabilite, costusroot, licorice, bupleurum, freeze-dry below -20℃, crush, put into extraction tank, and then use anhydrous ethanol for extraction, the extraction temperature is 80℃, the extraction pressure is 20KG / cm 2 , extraction time 3h, filtration after extraction to obtain filtrate II;

[0051] S4. Mix the filtrate I and filtrate II, adjust the pH to 5, concentrate to a relative density of 1.10 to obtain a fluid extract, add a pharmaceutically acceptable carrier, and prepare granules.

[0052] Example 3

[0053] A traditional Chinese medicine composition for preventing or treating constipation comprises the following raw materials by weight: 40 grams of Codonopsis pilosula, 20 grams of Atractylodes macrocephala, 21 grams of Poria cocos, 17 grams of fried Sanguisorba officinalis, 10 grams of Aquilaria sinensis, 13 grams of Linderae scutellariae, 8 grams of Scrophularia ningpoensis, 6 grams of Ophiopogon japonicus, 5 grams of Rehmannia root, 6 grams of Shenqu, 8 grams of Rhubarb, 5 grams of Citrus aurantium, 5 grams of Magnolia bark, 4 grams of Sodium sulfate, 6 grams of Aucklandia lappa, 5 grams of Radix Glycyrrhizae roasted, and 5 grams of Bupleurum chinense.

[0054] Example 4

[0055] A traditional Chinese medicine composition for preventing or treating constipation comprises the following raw materials by weight: 30 grams of Codonopsis pilosula, 15 grams of Atractylodes macrocephala, 19 grams of Poria cocos, 15 grams of fried Sanguisorba officinalis, 7 grams of Aquilaria sinensis, 10 grams of Linderae scutellariae, 6 grams of Scrophularia ningpoensis, 4 grams of Ophiopogon japonicus, 3 grams of Rehmannia root, 4 grams of Shenqu, 4 grams of Rhubarb, 3 grams of Citrus aurantium, 3 grams of Magnolia officinalis, 2 grams of Sodium sulfate, 4 grams of Aucklandia lappa, 3 grams of Radix Glycyrrhizae roasted, and 3 grams of Bupleurum chinense.

[0056] The above examples 3-4 adopt the following preparation method:

[0057] S1. According to the formula, the raw materials of Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Sanguisorba officinalis, Aquilaria sinensis, and Linderae strychnifolia are weighed, dried, crushed, and sieved to obtain coarse powder I for later use; Scrophularia ningpoensis, Ophiopogon japonicus, Rehmannia glutinosa, and Shenqu are weighed, dried, crushed, and sieved to obtain coarse powder II; the crushed particle size of the coarse powder I and coarse powder II is 920 μm;

[0058] S2, mixing the above coarse powder I and coarse powder II, adding purified water, the mass volume g / mL of the mixture of coarse powder I and coarse powder II and purified water is 8:20, ultrasonic extraction is performed 4 times, the power of ultrasonic extraction is 400W, the ultrasonic frequency is 100KHz, each time for 60min, filtering, and combining to obtain filtrate I;

[0059] S3, take rhubarb, immature bitter orange, magnolia bark, mirabilite, costusroot, licorice, bupleurum, freeze-dry below -20℃, crush, put into extraction tank, and then use anhydrous ethanol for extraction, the extraction temperature is 90℃, the extraction pressure is 50KG / cm 2 , extraction time 5h, filtration after extraction to obtain filtrate II;

[0060] S4. Mix the filtrate I and the filtrate II, adjust the pH to 7, concentrate to a relative density of 1.2 to obtain a fluid extract, add a pharmaceutically acceptable carrier, and prepare a pill.

[0061] Example 5

[0062] A traditional Chinese medicine composition for preventing or treating constipation comprises the following raw materials by weight: 35 grams of Codonopsis pilosula, 18 grams of Atractylodes macrocephala, 20 grams of Poria cocos, 16 grams of fried Sanguisorba officinalis, 8 grams of Aquilaria sinensis, 12 grams of Linderae scutellariae, 7 grams of Scrophularia ningpoensis, 5 grams of Ophiopogon japonicus, 4 grams of Rehmannia root, 5 grams of Shenqu, 6 grams of Rhubarb, 4 grams of Citrus aurantium, 4 grams of Magnolia officinalis, 3 grams of Sodium sulfate, 5 grams of Aucklandia lappa, 4 grams of Radix Glycyrrhizae roasted, and 4 grams of Bupleurum chinense.

[0063] The above-mentioned Example 5 adopts the following preparation method:

[0064] S1. According to the formula, the raw materials of Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Sanguisorba officinalis, Aquilaria sinensis, and Linderae strychnifolia are weighed, dried, crushed, and sieved to obtain coarse powder I for later use; Scrophularia ningpoensis, Ophiopogon japonicus, Rehmannia glutinosa, and Shenqu are weighed, dried, crushed, and sieved to obtain coarse powder II; the particle size of the coarse powder I and coarse powder II is 850 μm;

[0065] S2, mixing the above coarse powder I and coarse powder II, adding purified water, the mass volume g / mL of the mixture of coarse powder I and coarse powder II and purified water is 6:20, ultrasonic extraction is performed 3 times, the power of ultrasonic extraction is 350W, the ultrasonic frequency is 70KHz, each time is 50min, filtering, and combining to obtain filtrate I;

[0066] S3, take rhubarb, immature bitter orange, magnolia bark, mirabilite, costusroot, licorice, bupleurum, freeze-dry below -20℃, crush, put into extraction tank, and then use anhydrous ethanol for extraction, the extraction temperature is 85℃, the extraction pressure is 30KG / cm 2 , extraction time 4h, filtration after extraction to obtain filtrate II;

[0067] S4. Mix the filtrate I and filtrate II, adjust the pH to 6, concentrate to a relative density of 1.11 to obtain a fluid extract, add a pharmaceutically acceptable carrier, and prepare a capsule.

[0068] Experimental Example 5 Application of a Chinese medicine composition in the preparation of a medicament for preventing or treating constipation

[0069] 1. Animal experiments:

[0070] 1.1. Experimental animals: SPF mice, with a body weight of 30±5g, half male and half female, were fed adaptively for 1 week before the experiment. All experimental operations were in accordance with the requirements of the "Guidelines for the Management and Use of Laboratory Animals".

[0071] 1.2. Test drug: The Chinese medicine composition of Example 5 of the present invention was used.

[0072] 1.3. Modeling and drug administration: The mice were divided into 3 groups, including a normal control group, a model control group, and a Chinese medicine treatment group according to Example 5, with 10 mice in each group. Except for the normal control group, the other groups were modeled with gastrointestinal heat accumulation mice. The mice were placed in special cages, their activities were restricted, and high-fat, high-protein, low-fiber feed was provided; the Chinese medicine composition was prepared into a 2g / 100ml solution with physiological saline, and then the mice were gavaged, with 1ml of the drug solution being gavaged for every 100g of body weight.

[0073] 1.4. Observation indicators: Observe the defecation of mice at different time points before and after administration, including the number of defecation and stool shape indicators.

[0074] 1.5 Experimental results:

[0075]

[0076] From the above results, it can be seen that the Chinese medicine composition of the present invention has the function of increasing gastrointestinal motility and moisturizing the intestines to promote bowel movements, effectively improving the internal microecological environment of the mouse intestine, and preventing the occurrence of constipation. After administration, the frequency of bowel movements in mice is effectively improved, and the stool is long and oval in shape, dark brown or black in color, and has a moderate hardness and softness. The average stool weight of mice is 2.6 g, which is consistent with the amount of food intake and water intake, maintaining a certain balance.

[0077] 2. Clinical trials:

[0078] 2.1 Experimental subjects: A total of 100 eligible constipation patients aged between 18 and 65 years were recruited. All of them had varying degrees of constipation symptoms caused by gastrointestinal heat accumulation, Qi stagnation, and Yin-cold stagnation, such as decreased bowel movement, dry stools, and difficulty in defecation.

[0079] 2.2 Experimental method: The randomized controlled trial method was adopted to divide the patients into an experimental group and a control group, with 50 people in each group. The patients in the experimental group received the Chinese medicine composition treatment, and the patients in the control group received the placebo treatment.

[0080] 2.3 Administration: The patients in the experimental group took the Chinese medicine composition orally, 3 capsules each time, 3 times a day, for 2 consecutive weeks. The patients in the control group took the placebo orally, 3 capsules each time, 3 times a day, for 2 consecutive weeks.

[0081] 2.4 Observation indicators: Record the changes in constipation symptoms before and after treatment, including the number of bowel movements, stool shape, degree of defecation effort, etc. At the same time, observe the patient's adverse reactions.

[0082] 2.5 Efficacy standards:

[0083] Significant effect: The frequency of bowel movements increased, the stool shape became normal, the bowel movements became smooth, the stool became soft, the degree of straining during bowel movements was reduced, and the symptoms disappeared;

[0084] Effective: bowel movements occur once a day or every other day, the stool is of normal shape, the bowel movements are smooth, the stool is soft, the bowel movements are labored, and the symptoms disappear or are alleviated;

[0085] Ineffective: The number of bowel movements is the same as before treatment, and the symptoms are not relieved.

[0086] 2.5 Data analysis: The observed indicators were statistically analyzed to compare the improvement of constipation symptoms and the occurrence of adverse reactions in the experimental group and the control group.

[0087] 2.6 Test results:

[0088] Number of cases Significant effect efficient invalid Total effective rate% Experimental Group 50 48 2 0 100 Control group 50 12 2 36 28.0

[0089] After treatment, the constipation symptoms of the experimental group patients were significantly improved, the number of defecation increased, the stool shape was normal, and the degree of defecation effort was reduced. After treatment, the constipation symptoms of the control group patients were not significantly improved. According to the experimental results, the efficacy of the Chinese medicine composition of the present invention in treating constipation is better than that of placebo treatment, and the incidence of adverse reactions is low.

[0090] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for preventing or treating constipation, characterized in that: The invention is composed of the following raw materials in parts by weight: 25-45 parts of Codonopsis pilosula, 12-25 parts of Atractylodes macrocephala, 18-22 parts of Poria cocos, 10-18 parts of Sanguisorba officinalis, 5-12 parts of Aquilaria sinensis, 8-15 parts of Linderae scutellariae, 5-10 parts of Scrophularia ningpoensis, 3-8 parts of Ophiopogon japonicus, 2-6 parts of Rehmannia root, 2-8 parts of Shenqu, 3-9 parts of Rhubarb, 1-5 parts of Citrus aurantium, 2-7 parts of Magnolia officinalis, 1-5 parts of Sodium Sulfate, 2-8 parts of Aucklandia lappa, 2-7 parts of Radix Glycyrrhizae Preparata, and 2-6 parts of Bupleurum chinense; The method for preparing the Chinese medicine composition for preventing or treating constipation comprises the following steps: S1. According to the formula, the raw materials of Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Sanguisorba officinalis, Aquilaria sinensis, and Linderae scutellariae were weighed, dried, crushed, and sieved to obtain coarse powder I for later use; Scrophularia ningpoensis, Ophiopogon japonicus, Rehmannia glutinosa, and Shenqu were weighed, dried, crushed, and sieved to obtain coarse powder II; the particle size of coarse powder I and coarse powder II was 850±70μm; S2, mixing the above coarse powder I and coarse powder II, adding purified water, the mass volume g / mL of the mixture of coarse powder I and coarse powder II and purified water is 4-8:20, ultrasonic extraction is performed 2-4 times, each time for 40-60 min, the power of ultrasonic extraction is 300-400 W, the ultrasonic frequency is 20-100 KHz, filtering, and combining to obtain filtrate I; S3, take rhubarb, immature bitter orange, magnolia bark, mirabilite, costusroot, licorice root, bupleurum, freeze-dry below -20℃, crush, put into extraction tank, and then use anhydrous ethanol for extraction, the extraction temperature is 80-90℃, the extraction pressure is 20-50KG / cm 2 , extraction time 3-5h, filtering after extraction to obtain filtrate II; S4. Mix the filtrate I and the filtrate II, adjust the pH to 5-7, and concentrate to a relative density of 1.10-1.2 to obtain a Chinese medicine composition.

2. A Chinese medicine composition for preventing or treating constipation according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 30-40 parts of Codonopsis pilosula, 15-20 parts of Atractylodes macrocephala, 19-21 parts of Poria cocos, 15-17 parts of fried Sanguisorba officinalis, 7-10 parts of Aquilaria woodii, 10-13 parts of Linderae scutellariae, 6-8 parts of Scrophularia ningpoensis, 4-6 parts of Ophiopogon japonicus, 3-5 parts of Rehmannia root, 4-6 parts of Shenqu, 4-8 parts of Rhubarb, 3-5 parts of Citrus aurantium, 3-5 parts of Magnolia officinalis, 2-4 parts of Sodium sulfate, 4-6 parts of Costus root, 3-5 parts of Radix Glycyrrhizae roasted and 3-5 parts of Bupleurum chinense.

3. A Chinese medicine composition for preventing or treating constipation according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 35 parts of Codonopsis pilosula, 18 parts of Atractylodes macrocephala, 20 parts of Poria cocos, 16 parts of fried Sanguisorba officinalis, 8 parts of Aquilaria woodii, 12 parts of Linderae scutellariae, 7 parts of Scrophularia ningpoensis, 5 parts of Ophiopogon japonicus, 4 parts of Rehmannia root, 5 parts of Shenqu, 6 parts of Rhubarb, 4 parts of Citrus aurantium, 4 parts of Magnolia bark, 3 parts of Sodium sulfate, 5 parts of Aucklandia lappa, 4 parts of Radix Glycyrrhizae roasted, and 4 parts of Radix Bupleuri.

4. A Chinese medicine composition for preventing or treating constipation according to any one of claims 1 to 3, characterized in that: The raw materials are added with pharmaceutically acceptable auxiliary materials to prepare any dosage form.

5. Use of a Chinese medicine composition for preventing or treating constipation as claimed in any one of claims 1 to 3 in the preparation of a medicine for preventing or treating constipation.

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