CN114129684B - Traditional Chinese medicine composition and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition and a preparation method and application thereof, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-15 parts of rhizoma atractylodis, 10-14 parts of agastache rugosus, 10-14 parts of mangnolia officinalis, 10-14 parts of dried orange peel, 10-14 parts of artemisia capillaries, 2-5 parts of rhizoma zingiberis, 7-10 parts of rhizoma acori graminei, 19-23 parts of red paeony root, 19-23 parts of rhizoma phragmitis, 3-6 parts of round cardamom, 11-15 parts of cuttlebone, 14-18 parts of rhizoma bletillae, 5-9 parts of rhizoma pinelliae preparata and 4-8 parts of liquorice. The selected raw material medicines of the traditional Chinese medicine composition accord with the compatibility principle of monarch, minister, assistant and guide, and all the components are cooperated or shared, so that the traditional Chinese medicine composition has the effects of activating spleen and regulating the middle warmer, and resolving dampness and relieving pain.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and a preparation method thereof, and application of the traditional Chinese medicine composition in treating chronic superficial gastritis.
Background
The spleen and stomach diseases are the most common and most frequent diseases in the traditional Chinese medicine clinic. Because the current living standard is improved, the work rhythm is accelerated, the competition is fierce, and the mental factor of people who are easy to move liver qi is the intrinsic factor of the disease. The wine is not eaten in a proper amount, so that the wine is wet in the interior. Acute food, fast food, cold food, hot food, overeating and dirty food all cause dampness in the interior. The accumulation of damp-food can lead to dysfunction of the spleen in transport and transformation, stagnation of the spleen due to long-term depression, and disease. The chronic superficial gastritis (CSG for short) belongs to a common category of spleen and stomach diseases in traditional Chinese medicine, has extremely high prevalence rate, is the first gastric disease and accounts for about 80-90 percent of patients who receive gastroscopy, and has the main symptoms that the patients can have dyspepsia symptoms of different degrees, such as epigastric discomfort and dull pain after eating, eructation, nausea, pantothenic acid and occasional vomiting. Modern medicine mainly aims at relieving symptoms and improving gastric mucositis for treating chronic superficial gastritis, and no specific treatment method or treatment medicine exists at present.
The stomach calming powder is taken as a basic formula, comes from the 'Taiping Huimin He Ji Ju Fang', is applied to the treatment of the spleen and stomach diseases for over 900 years, and the clinical proved formula 'modified stomach calming powder' developed on the basis of the stomach calming powder expands the application range and shows the unique value and advantages of the traditional Chinese medicine. With the development of traditional Chinese medicines, numerous small compound prescriptions and 'drug pairs' are derived on the basis of the prescription of the Pingwei powder, but the existing small compound prescriptions or 'drug pairs' have no obvious effect on treating chronic gastritis, while the existing western medicine symptomatic treatment has better temporary curative effect but is easy to relapse, and some drugs are suitable for generating drug dependence after long-term application.
Disclosure of Invention
In view of the above, the present invention provides a traditional Chinese medicine composition, wherein the traditional Chinese medicine composition uses rhizoma atractylodis and agastache rugosus as monarch drugs, mangnolia officinalis and dried orange peel as ministerial drugs, red peony root, rhizoma phragmitis, artemisia capillaries, rhizoma coptidis from ginger, rhizoma acori graminei, fructus amomi rotundus, rhizoma pinelliae preparata, rhizoma bletillae and cuttlebone as adjuvant drugs, and all the components are cooperated or shared, so that the traditional Chinese medicine composition has the effects of activating spleen and regulating stomach, resolving dampness and relieving pain.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention firstly provides a traditional Chinese medicine composition which comprises the following raw materials in parts by weight: 10-15 parts of rhizoma atractylodis, 10-14 parts of agastache rugosus, 10-14 parts of mangnolia officinalis, 10-14 parts of dried orange peel, 10-14 parts of artemisia capillaries, 2-5 parts of rhizoma zingiberis, 7-10 parts of rhizoma acori graminei, 19-23 parts of red paeony root, 19-23 parts of rhizoma phragmitis, 3-6 parts of round cardamom, 11-15 parts of cuttlebone, 14-18 parts of rhizoma bletillae, 5-9 parts of rhizoma pinelliae preparata and 4-8 parts of liquorice.
Further scheme, the material comprises the following raw materials in parts by weight: 10-12 parts of rhizoma atractylodis, 10-12 parts of agastache rugosus, 10-11 parts of mangnolia officinalis, 10-12 parts of dried orange peel, 10-12 parts of artemisia capillaries, 2-3 parts of rhizoma zingiberis, 7-9 parts of rhizoma acori graminei, 19-21 parts of red paeony root, 19-21 parts of rhizoma phragmitis, 3-5 parts of round cardamom, 11-13 parts of cuttlebone, 14-16 parts of rhizoma bletillae, 5-7 parts of rhizoma pinelliae preparata and 4-6 parts of liquorice.
Further scheme, the material comprises the following raw materials in parts by weight: 10 parts of rhizoma atractylodis, 10 parts of agastache rugosus, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 10 parts of artemisia capillaries, 2 parts of rhizoma coptidis from ginger, 7 parts of rhizoma acori graminei, 19 parts of radix paeoniae rubra, 19 parts of rhizoma phragmitis, 3 parts of cardamom, 11 parts of cuttlebone, 14 parts of rhizoma bletillae, 5 parts of rhizoma pinelliae from ginger and 4 parts of liquorice;
or 12 parts of rhizoma atractylodis, 12 parts of wrinkled gianthyssop herb, 11 parts of mangnolia officinalis, 12 parts of dried orange peel, 12 parts of artemisia capillaries, 3 parts of rhizoma coptidis from rhizomes, 9 parts of rhizoma acori graminei, 21 parts of red paeony roots, 21 parts of rhizoma phragmitis, 5 parts of round cardamom, 13 parts of cuttlebone, 16 parts of rhizoma bletillae, 7 parts of rhizoma pinelliae from rhizomes and 6 parts of liquorice;
or 15 parts of rhizoma atractylodis, 14 parts of agastache rugosus, 14 parts of mangnolia officinalis, 14 parts of dried orange peel, 14 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 10 parts of rhizoma acori graminei, 23 parts of red paeony root, 23 parts of rhizoma phragmitis, 6 parts of round cardamom, 15 parts of cuttlebone, 18 parts of rhizoma bletillae, 9 parts of rhizoma pinelliae preparata and 8 parts of liquorice.
In a further scheme, the traditional Chinese medicine composition is any pharmaceutically acceptable dosage form.
In a further scheme, the pharmaceutically acceptable dosage form is granules, oral solutions, tablets, capsules or pills.
In a further aspect, the traditional Chinese medicine composition is used for treating chronic superficial gastritis.
The invention further provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
a) Extracting cortex Magnolia officinalis with 8-12 times of 60-80% ethanol for 1-3 times, each for 1-3 hr, filtering, mixing filtrates, recovering ethanol, concentrating, and freeze drying at-80 deg.C to-60 deg.C to obtain dry extract;
b) Soaking rhizoma Atractylodis, herba Agastaches, pericarpium Citri Tangerinae, rhizoma Acori Graminei and fructus Amomi rotundus in water for 1-3 hr, extracting volatile oil by steam distillation for 2-6 hr, and collecting volatile oil; collecting the distilled water solution in another container;
c) Mixing the volatile oil-extracted raw materials with the rest raw materials, decocting in water for 2-5 times (each for 1-3 hr), filtering, and mixing with the volatile oil-extracted water solution to obtain extractive solution;
d) Concentrating the extracting solution to the relative density of 1.10-1.20 at 60 ℃ to obtain concentrated solution;
e) Mixing the concentrated solution obtained in the step D) with ethanol until the alcohol content is 65% -75%, and carrying out alcohol precipitation to obtain alcohol precipitation supernatant;
f) Concentrating the supernatant to 60 deg.C with relative density of 1.25-1.35 to obtain concentrated solution again;
g) Freeze drying the concentrated solution obtained in the step F) at-80 to-60 ℃ to obtain a water extraction and alcohol precipitation traditional Chinese medicine composition;
h) The collected volatile oil is included by a water saturation method;
i) Crushing the dry paste obtained in the step A) and the step G), and uniformly mixing the crushed dry paste with the volatile oil inclusion compound obtained in the step H) to obtain the traditional Chinese medicine composition.
In a further scheme, in the step A), the mass ratio of the total amount of the ethanol to the total amount of each raw material medicine is 9-15.
In a further scheme, the time for extracting the volatile oil in the step B) is 5 hours.
Further, the concentration temperature of the step D) is 55-65 ℃.
Compared with the prior art, the invention has the following beneficial effects:
the traditional Chinese medicine composition provided by the invention has the effects of activating spleen and regulating stomach, and eliminating dampness and relieving pain, the full formula combines pungent, dry and bitter in nature and flavor to exert the functions of eliminating and dispersing the pathogenic factors so as to adjust the functions of spleen transportation, stomach elimination and intestinal motility, and can calm the unevenness of gastric soil, is mainly used for treating chronic superficial gastritis (stomach pain and epigastric fullness syndrome), and has ideal effect.
Drawings
FIG. 1 is a pathological graph showing the effect of normal group on gastric mucosal tissue of rats with chronic gastritis;
FIG. 2 is a pathological diagram of the effect of model groups on gastric mucosal tissue of rats with chronic gastritis;
FIG. 3 is a pathological diagram of the positive group's effect on the gastric mucosal tissue of rats with chronic gastritis;
FIG. 4 is a pathological diagram showing the effect of the decoction set of the Chinese medicinal composition of example 5 on the gastric mucosal tissue of rats with chronic gastritis;
FIG. 5 is a pathological graph of the effect of high, medium and low dose groups of the granules of the Chinese medicinal composition of example 5 on the gastric mucosal tissues of rats with chronic gastritis;
FIG. 6 is a pathological diagram showing the effects of the Chinese medicinal composition of comparative examples 14 to 19 on the tissues of the gastric mucosa of rats with chronic gastritis.
Detailed Description
In order that the invention may be more fully understood, reference will now be made to the specific embodiments illustrated. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
The invention discloses a traditional Chinese medicine composition, which comprises the following raw materials in parts by weight: 10-15 parts of rhizoma atractylodis, 10-14 parts of agastache rugosus, 10-14 parts of mangnolia officinalis, 10-14 parts of dried orange peel, 10-14 parts of artemisia capillaries, 2-5 parts of rhizoma zingiberis, 7-10 parts of rhizoma acori graminei, 19-23 parts of red paeony root, 19-23 parts of rhizoma phragmitis, 3-6 parts of round cardamom, 11-15 parts of cuttlebone, 14-18 parts of rhizoma bletillae, 5-9 parts of rhizoma pinelliae preparata and 4-8 parts of liquorice.
In the Chinese medicinal composition, the main medicaments of rhizoma atractylodis and agastache rugosus and the bitter Wen Xinsao are used for removing dampness and activating spleen, the auxiliary medicaments of magnolia officinalis and dried orange peel are used for strengthening the function of removing dampness, the auxiliary medicaments of artemisia capillaries, rhizoma zingiberis, rhizoma acori graminei, fructus amomi rotundus, ginger processed pinellia ternate, rhizoma bletillae and cuttlebone are used for digesting bitter pungent and antacid and astringing ulcer as adjuvant medicaments, and the auxiliary medicaments of magnolia officinalis and dried orange peel are used for assisting in guiding qi downward and descending adverse qi, and the liquorice is sweet and moderate in regulating the middle. The whole formula aims at combining pungent, dry and bitter in flavor, and exerting the functions of eliminating and dispersing the pathogenic factors, thereby regulating the functions of spleen transportation, stomach digestion and intestinal motility and calming the unevenness of stomach and earth. It is indicated for damp-turbidity retention in middle energizer.
Specifically, the selected raw material medicines accord with the compatibility principle of monarch, minister, assistant and guide, and the rhizoma atractylodis and the agastache are taken as monarch medicines in the formula, so that the Chinese medicinal composition has the effects of eliminating dampness, activating spleen, aromatizing and harmonizing stomach; rhizoma Atractylodis, pungent and bitter in flavor and warm in nature, has the effects of eliminating dampness and invigorating spleen, and is mainly used for treating diseases such as psychroalgia of spleen and stomach, listlessness and lethargy, chest fullness and abdominal distention, anorexia, emesis and diarrhea. Agastache rugosus, pungent in flavor and slightly warm in nature; herba Agastaches has effects of eliminating dampness with aromatics, regulating stomach function and relieving vomit. It can be used for treating damp obstruction of middle energizer manifested by abdominal distention, anorexia, emesis, and diarrhea. The two ingredients have synergistic effect, and have effects of activating spleen and regulating stomach, eliminating dampness and relieving pain, and aromatizing and regulating stomach function, so as to remove dampness, turbid stagnation and stagnation in middle-jiao.
The officinal magnolia bark and the dried orange peel are used as ministerial drugs, and the officinal magnolia bark is bitter and pungent in taste and warm in nature. Has the effects of promoting qi circulation, removing food retention, eliminating dampness and relieving fullness. Mainly treats the symptoms of food retention, qi stagnation, abdominal distension, constipation, dampness obstruction in middle energizer, epigastric fullness, vomiting and diarrhea and the like, regulates qi, eliminates dampness, eliminates stagnation and relieves distension; tangerine peel is pungent and bitter in flavor and warm in nature. Has the effects of regulating qi-flowing, lowering adverse flow of qi, regulating middle warmer, stimulating appetite, eliminating dampness and eliminating phlegm, and can be used for treating stagnation of qi and dampness of spleen and stomach, fullness and stuffiness of chest and diaphragm, abdominal distention and pain, anorexia, emesis, singultus, etc. The two herbs have synergistic effect to dry dampness, strengthen spleen, resolve fat turbidity, and tonify the root of spleen deficiency and qi weakness.
Radix Paeoniae Rubra and rhizoma Phragmitis have effects in dispersing stagnated liver qi, resolving stagnation, resolving food stagnation, and activating qi-flowing; artemisia capillaris Thunb, rhizoma Coptidis, rhizoma Acori Tatarinowii, fructus Amomi rotundus, rhizoma Pinelliae preparata, rhizoma Bletillae, endoconcha Sepiae, herba asari, digestion promoting, antacid and ulcer healing are adjuvant drugs, and have effects of nourishing the middle-jiao and clearing away heat, invigorating the middle-jiao, strengthening the stomach and spleen, warm-blooded detoxification, promoting spleen and stomach strengthening, nourishing blood and detoxification, invigorating spleen and stomach, regulating qi-flowing and relieving pain, warming the middle-jiao and dispelling cold, dispersing stagnated liver qi and relieving qi stagnation.
Licorice root, radix Glycyrrhizae is sweet and mild in flavor and acts as a guiding drug to regulate the function of the other drugs in the recipe.
The whole formula has the effects of eliminating dampness, activating spleen, aromatizing, regulating the middle warmer, relieving spasm, relieving pain, promoting qi circulation and relieving distension, and on the basis, the addition and subtraction of the medicinal materials are carried out according to the clinical symptoms of patients, so that the dosage of the medicinal materials is flexibly adjusted, and the disease progress can be more effectively controlled. Therefore, the traditional Chinese medicine composition improves the symptoms of the patient such as gastric cavity dull pain, nausea and vomiting, and has obvious curative effect on chronic superficial gastritis.
According to a further scheme, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-12 parts of rhizoma atractylodis, 10-12 parts of agastache rugosus, 10-11 parts of mangnolia officinalis, 10-12 parts of dried orange peel, 10-12 parts of artemisia capillaries, 2-3 parts of rhizoma zingiberis, 7-9 parts of rhizoma acori graminei, 19-21 parts of radix paeoniae rubra, 19-21 parts of rhizoma phragmitis, 3-5 parts of fructus amomi rotundus, 11-13 parts of cuttlebone, 14-16 parts of rhizoma bletillae, 5-7 parts of rhizoma pinelliae preparata and 4-6 parts of liquorice.
Preferably, in one or more embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials by weight: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 10 parts of artemisia capillaries, 2 parts of rhizoma coptidis from rhizomes, 7 parts of rhizoma acori graminei, 19 parts of red paeony roots, 19 parts of rhizoma phragmitis, 3 parts of round cardamom, 11 parts of cuttlebone, 14 parts of rhizoma bletillae, 5 parts of rhizoma pinelliae from rhizomes and 4 parts of liquorice;
or 12 parts of rhizoma atractylodis, 12 parts of wrinkled gianthyssop herb, 11 parts of mangnolia officinalis, 12 parts of dried orange peel, 12 parts of artemisia capillaries, 3 parts of rhizoma coptidis from rhizomes, 9 parts of rhizoma acori graminei, 21 parts of red paeony roots, 21 parts of rhizoma phragmitis, 5 parts of round cardamom, 13 parts of cuttlebone, 16 parts of rhizoma bletillae, 7 parts of rhizoma pinelliae from rhizomes and 6 parts of liquorice;
or 15 parts of rhizoma atractylodis, 14 parts of agastache rugosus, 14 parts of mangnolia officinalis, 14 parts of dried orange peel, 14 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 10 parts of rhizoma acori graminei, 23 parts of red paeony root, 23 parts of rhizoma phragmitis, 6 parts of round cardamom, 15 parts of cuttlebone, 18 parts of rhizoma bletillae, 9 parts of rhizoma pinelliae preparata and 8 parts of liquorice.
In a further scheme, the traditional Chinese medicine composition further comprises pharmaceutically acceptable auxiliary materials, so that the traditional Chinese medicine composition can be any pharmaceutically acceptable dosage form, such as granules, oral solutions, tablets, capsules or pills.
In a further scheme, the traditional Chinese medicine composition is used for treating chronic superficial gastritis.
The second aspect of the invention provides a preparation method of the traditional Chinese medicine composition of the first aspect of the invention, which comprises the steps of sequentially carrying out alcohol extraction, volatile oil extraction, water extraction, alcohol precipitation, freeze drying and one-step granulation on raw materials, thereby extracting effective components from the medicine composition to the maximum extent, applying a freeze-drying technology to ensure that the medicinal material basis of a clinical proved prescription (decoction) is not obviously changed, and the traditional Chinese medicine composition still has the same effect after being prepared into granules, oral solutions, tablets, capsules or pills. The preparation method of the traditional Chinese medicine composition comprises the following steps:
a) Extracting cortex Magnolia officinalis with 8-12 times of 60-80% ethanol for 1-3 times, each for 1-3 hr, filtering, mixing filtrates, recovering ethanol, concentrating, and freeze drying at-80 deg.C to-60 deg.C to obtain dry extract;
b) Soaking rhizoma Atractylodis, herba Agastaches, pericarpium Citri Tangerinae, rhizoma Acori Graminei and fructus Amomi rotundus in water for 1-3 hr, extracting volatile oil by steam distillation for 2-6 hr, and collecting volatile oil; collecting the distilled water solution in another container;
c) Mixing the volatile oil-extracted raw materials with the rest raw materials, decocting in water for 2-5 times (each for 1-3 hr), filtering, and mixing with the water solution after volatile oil extraction to obtain extractive solution;
d) Concentrating the extracting solution to the relative density of 1.10-1.20 at 60 ℃ to obtain a concentrated solution;
e) Mixing the concentrated solution obtained in the step D) with ethanol until the alcohol content is 65% -75%, and carrying out alcohol precipitation to obtain alcohol precipitation supernatant;
f) Concentrating the alcohol precipitation supernatant to 60 ℃ and obtain a concentrated solution, wherein the relative density of the concentrated solution is 1.25-1.35;
g) Freeze-drying the concentrated solution obtained in the step F) at-80 to-60 ℃ to obtain a water extraction and alcohol precipitation traditional Chinese medicine composition;
h) Collecting volatile oil, and including with water saturation method;
i) And D) crushing the dry paste obtained in the step A) and the step G), and uniformly mixing the crushed dry paste and the volatile oil inclusion compound obtained in the step H) to obtain the traditional Chinese medicine composition.
In a further scheme, in the step A), the mass ratio of the total amount of the ethanol to the total amount of each raw material medicine is 9-15.
In a further scheme, the time for extracting the volatile oil in the step B) is 5 hours.
Further, the concentration temperature of the step D) is 55-65 ℃.
In one or more embodiments of the invention, the concentrated solution is dried by a freeze dryer, the temperature of the freeze dryer is set to-80, -70 ℃ and-60 ℃, the dried solid is crushed into fine powder, and the fine powder is sieved by a 80-mesh sieve, so as to obtain the traditional Chinese medicine composition. The temperature of the drying is preferably-80 ℃.
The volatile oil inclusion compound can adopt a conventional inclusion mode in the field without special limitation, and in one or more embodiments of the invention, the specific steps are as follows: embedding the volatile oil with beta-cyclodextrin to form an inclusion compound, and drying for later use; the embedding method of the volatile oil comprises the following steps: the weight ratio of volatile oil: beta-cyclodextrin: water =1:10: grinding at 18,2mm grinding clearance for 15 min to form inclusion, drying, and pulverizing into coarse powder;
after drying and crushing, the traditional Chinese medicine composition can be prepared into corresponding dosage forms according to the conventional process means of the technicians in the field, specifically:
when the Chinese medicinal composition is a granule, pulverizing the dried solid, sieving, mixing with adjuvants, granulating with water as binder in fluidized bed, drying, grading, and packaging; the fluidized bed one-step granulation parameters of the steps are that the fan frequency is 15-40Hz, and the air intake is 60-150m 3 H, the air inlet temperature is 90 ℃, the material temperature is 70-80 ℃, the air outlet temperature is 50-60 ℃, and the rotation speed of a liquid supply pump is 25r/min.
When the Chinese medicinal composition is a tablet, the dried solid is crushed, sieved, mixed with auxiliary materials uniformly, granulated and tableted to obtain the Chinese medicinal composition; the granulation in the step is fluidized bed granulation, the tabletting parameters are within the pressure range of 10-30 KN, and the tabletting speed is 27000 tablets/hour.
When the Chinese medicinal composition is a capsule, pulverizing the dried solid, sieving, mixing with adjuvants, granulating, and encapsulating; the granulation in the step is granulation by using 92% ethanol and a 24-mesh sieve, the dosage of the ethanol is 12mL/50g, the stirring time is 1min, and the drying time is 0.5h;
when the traditional Chinese medicine composition is an oral solution, the traditional Chinese medicine raw materials are prepared into the oral solution by the processes of alcohol extraction, volatile oil extraction, water extraction, alcohol precipitation, filtration, concentration, diluted preparation, refrigeration and the like; the diluted preparation in the step is that the concentrated solution is diluted by adding purified water and refrigerated for 48 hours at 4-8 ℃.
The technical solution of the present invention will be more fully described with reference to the following specific examples.
EXAMPLE 1 preparation of the Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of agastache rugosus, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 10 parts of artemisia capillaries, 2 parts of rhizoma coptidis from ginger, 7 parts of rhizoma acori graminei, 19 parts of radix paeoniae rubra, 19 parts of rhizoma phragmitis, 3 parts of cardamom, 11 parts of cuttlebone, 14 parts of rhizoma bletillae, 5 parts of rhizoma pinelliae from ginger and 4 parts of liquorice;
the preparation method comprises the following specific steps:
1) Cleaning cortex Magnolia officinalis, cutting, extracting with 70% ethanol under reflux for 3 times, adding 11 times of 70% ethanol for the first time, adding 10 times of 70% ethanol for the second time, extracting for 2 hr each time, filtering, mixing filtrates, recovering ethanol, concentrating, and freeze drying at-80 deg.C to obtain dry extract, wherein the concentration is performed with single-effect evaporator at 60 deg.C and vacuum degree: -0.06MPa;
2) Soaking rhizoma Atractylodis, herba Agastaches, pericarpium Citri Tangerinae, rhizoma Acori Graminei and fructus Amomi rotundus in 10 times of water for 1 hr, and extracting volatile oil by steam distillation for 5 hr to obtain volatile oil extract;
3) Embedding the volatile oil with beta-cyclodextrin;
4) Mixing the volatile oil-extracted raw materials with the rest raw materials, decocting in water for 2-5 times (each for 1-3 hr), filtering, and mixing with the volatile oil-extracted water solution to obtain extractive solution;
5) Concentrating the extracting solution to the relative density of 1.10-1.20 at 60 ℃ to obtain a concentrated solution;
6) Mixing the concentrated solution with ethanol until the alcohol content is 65% -75%, and carrying out alcohol precipitation to obtain alcohol precipitation supernatant;
7) Concentrating the alcohol precipitation supernatant to 60 ℃ and obtain a concentrated solution, wherein the relative density of the concentrated solution is 1.25-1.35;
8) Freeze-drying the concentrated solution obtained in the step 7) to obtain freeze-dried powder of the traditional Chinese medicine composition;
9) And (3) uniformly mixing the freeze-dried powder obtained in the steps 1) and 8) to obtain the traditional Chinese medicine composition.
Comparative example 1 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 20 parts of rhizoma atractylodis, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 10 parts of artemisia capillaries, 2 parts of rhizoma zingiberis, 7 parts of rhizoma acori graminei, 19 parts of radix paeoniae rubra, 19 parts of rhizoma phragmitis, 3 parts of fructus amomi rotundus, 11 parts of cuttlebone, 14 parts of rhizoma bletillae, 5 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 2 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 20 parts of wrinkled gianthyssop herb, 10 parts of officinal magnolia bark, 10 parts of tangerine peel, 10 parts of artemisia capillaries, 2 parts of rhizoma zingiberis, 7 parts of grassleaf sweelflag rhizome, 19 parts of red paeony root, 19 parts of reed rhizome, 3 parts of round cardamom, 11 parts of cuttlebone, 14 parts of common bletilla pseudobulb, 5 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 3 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 20 parts of mangnolia officinalis, 10 parts of artemisia capillaries, 2 parts of rhizoma zingiberis, 7 parts of rhizoma acori graminei, 19 parts of radix paeoniae rubra, 19 parts of rhizoma phragmitis, 3 parts of round cardamom, 11 parts of cuttlebone, 14 parts of rhizoma bletillae, 5 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 4 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 20 parts of dried orange peel, 10 parts of artemisia capillaries, 2 parts of rhizoma zingiberis, 7 parts of rhizoma acori graminei, 19 parts of red paeony root, 19 parts of rhizoma phragmitis, 3 parts of round cardamom, 11 parts of cuttlebone, 14 parts of rhizoma bletillae, 5 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 5 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 3 parts of rhizoma zingiberis recens and coptis chinensis, 8 parts of rhizoma acori graminei, 20 parts of red paeony root, 20 parts of rhizoma phragmitis, 4 parts of round cardamom, 13 parts of cuttlebone, 16 parts of rhizoma bletillae, 6 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 6 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 10 parts of artemisia capillaries, 7 parts of rhizoma acori graminei, 19 parts of red paeony root, 19 parts of rhizoma phragmitis, 4 parts of round cardamom, 11 parts of cuttlebone, 14 parts of rhizoma bletillae, 6 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 7 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of officinal magnolia bark, 10 parts of dried orange peel, 11 parts of artemisia capillaries, 3 parts of rhizoma zingiberis, 19 parts of red paeony root, 20 parts of reed rhizome, 4 parts of round cardamom, 12 parts of cuttlebone, 15 parts of common bletilla pseudobulb, 6 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 8 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 13 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 9 parts of rhizoma acori graminei, 21 parts of rhizoma phragmitis, 5 parts of round cardamom, 13 parts of cuttlebone, 16 parts of rhizoma bletillae, 8 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 9 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 13 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 9 parts of rhizoma acori graminei, 21 parts of red paeony root, 5 parts of round cardamom, 13 parts of cuttlebone, 16 parts of rhizoma bletillae, 8 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 10 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 11 parts of artemisia capillaries, 3 parts of rhizoma zingiberis, 7 parts of rhizoma acori graminei, 19 parts of red paeony root, 19 parts of rhizoma phragmitis, 11 parts of cuttlebone, 14 parts of rhizoma bletillae, 6 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 11 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of officinal magnolia bark, 10 parts of tangerine peel, 13 parts of artemisia capillaries, 4 parts of rhizoma coptidis from rhizomes, 9 parts of rhizoma acori graminei, 20 parts of red paeony root, 20 parts of rhizoma phragmitis, 5 parts of round cardamom, 14 parts of rhizoma bletillae, 5 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 12 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 12 parts of artemisia capillaries, 4 parts of rhizoma coptidis from rhizomes, 9 parts of rhizoma acori graminei, 21 parts of red paeony roots, 21 parts of rhizoma phragmitis, 5 parts of round cardamom, 13 parts of cuttlebone, 5 parts of rhizoma pinelliae preparata and 4 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 13 preparation of a Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 10 parts of artemisia capillaries, 3 parts of rhizoma coptidis from rhizomes, 8 parts of rhizoma acori graminei, 19 parts of red paeony roots, 19 parts of rhizoma phragmitis, 5 parts of round cardamom, 12 parts of cuttlebone, 14 parts of rhizoma bletillae and 4 parts of liquorice;
the preparation method is the same as example 1.
EXAMPLE 2 preparation of the Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 11 parts of rhizoma atractylodis, 12 parts of wrinkled gianthyssop herb, 11 parts of mangnolia officinalis, 11 parts of dried orange peel, 12 parts of artemisia capillaries, 3 parts of rhizoma coptidis from rhizomes, 9 parts of rhizoma acori graminei, 21 parts of red paeony roots, 21 parts of rhizoma phragmitis, 5 parts of round cardamom, 13 parts of cuttlebone, 16 parts of rhizoma bletillae, 7 parts of rhizoma pinelliae from rhizomes and 6 parts of liquorice;
the preparation method is the same as example 1.
Examples3 preparation of the Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 12 parts of rhizoma atractylodis, 12 parts of wrinkled gianthyssop herb, 11 parts of mangnolia officinalis, 12 parts of dried orange peel, 14 parts of artemisia capillaries, 3 parts of rhizoma coptidis from rhizomes, 9 parts of rhizoma acori graminei, 21 parts of red paeony roots, 21 parts of rhizoma phragmitis, 5 parts of round cardamom, 13 parts of cuttlebone, 16 parts of rhizoma bletillae, 7 parts of rhizoma pinelliae from rhizomes and 6 parts of liquorice;
the preparation method is the same as example 1.
EXAMPLE 4 preparation of the Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 13 parts of rhizoma atractylodis, 13 parts of agastache rugosus, 13 parts of mangnolia officinalis, 14 parts of dried orange peel, 14 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 10 parts of rhizoma acori graminei, 23 parts of red paeony root, 23 parts of rhizoma phragmitis, 6 parts of round cardamom, 12 parts of cuttlebone, 16 parts of rhizoma bletillae, 9 parts of rhizoma pinelliae preparata and 8 parts of liquorice;
the preparation method is the same as example 1.
EXAMPLE 5 preparation of the Chinese medicinal composition
The traditional Chinese medicine composition comprises the following raw materials: 15 parts of rhizoma atractylodis, 14 parts of agastache rugosus, 14 parts of mangnolia officinalis, 14 parts of dried orange peel, 14 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 10 parts of rhizoma acori graminei, 23 parts of red paeony root, 23 parts of rhizoma phragmitis, 6 parts of round cardamom, 15 parts of cuttlebone, 18 parts of rhizoma bletillae, 9 parts of rhizoma pinelliae preparata and 8 parts of liquorice;
the preparation method is the same as example 1.
Preparation of related formula-dismantling traditional Chinese medicine composition
Comparative example 14 lack of radix paeoniae rubrathe and licorice root medicine formula
Taking 15 parts of rhizoma atractylodis, 14 parts of wrinkled gianthyssop herb, 14 parts of mangnolia officinalis, 14 parts of dried orange peel, 14 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 10 parts of rhizoma acori graminei, 23 parts of rhizoma phragmitis, 6 parts of round cardamom, 15 parts of cuttlebone, 18 parts of rhizoma bletillae and 9 parts of rhizoma pinelliae preparata;
the preparation method is the same as example 1.
Comparative example 15 lack of rhizoma atractylodis and dried orange peel medicine formula
Taking 14 parts of wrinkled gianthyssop herb, 14 parts of mangnolia officinalis, 14 parts of artemisia capillaries, 5 parts of rhizoma coptidis from ginger, 10 parts of rhizoma acori graminei, 23 parts of red paeony root, 23 parts of rhizoma phragmitis, 6 parts of round cardamom, 15 parts of cuttlebone, 18 parts of rhizoma bletillae, 9 parts of rhizoma pinelliae from ginger and 8 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 16 lack of rhizoma atractylodis and agastache rugosus medicine formula
Taking 14 parts of mangnolia officinalis, 14 parts of pericarpium citri reticulatae, 14 parts of artemisia capillaries, 5 parts of rhizoma coptidis from ginger, 10 parts of rhizoma acori graminei, 23 parts of radix paeoniae rubra, 23 parts of rhizoma phragmitis, 6 parts of fructus amomi rotundus, 15 parts of cuttlebone, 18 parts of rhizoma bletillae, 9 parts of rhizoma pinelliae from ginger and 8 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 17 lack of rhizoma atractylodis and ginger processed pinellia tuber medicine formula
Taking 14 parts of wrinkled gianthyssop herb, 14 parts of mangnolia officinalis, 14 parts of dried orange peel, 14 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 10 parts of rhizoma acori graminei, 23 parts of red paeony root, 23 parts of rhizoma phragmitis, 6 parts of round cardamom, 15 parts of cuttlebone, 18 parts of rhizoma bletillae and 8 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 18 Magnolia officinalis and dried orange peel medicinal composition
Taking 15 parts of rhizoma atractylodis, 14 parts of agastache rugosus, 14 parts of artemisia capillaries, 5 parts of rhizoma coptidis with ginger, 10 parts of rhizoma acori graminei, 23 parts of radix paeoniae rubra, 23 parts of rhizoma phragmitis, 6 parts of cardamom, 15 parts of cuttlebone, 18 parts of rhizoma bletillae, 9 parts of rhizoma pinelliae preparata and 8 parts of liquorice;
the preparation method is the same as example 1.
Comparative example 19 rhizoma bletillae and cuttlebone medicine formula
Taking 15 parts of rhizoma atractylodis, 14 parts of wrinkled gianthyssop herb, 14 parts of mangnolia officinalis, 14 parts of dried orange peel, 14 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 10 parts of rhizoma acori graminei, 23 parts of red paeony root, 23 parts of rhizoma phragmitis, 6 parts of round cardamom, 9 parts of rhizoma pinelliae preparata and 8 parts of liquorice;
the preparation method is the same as example 1.
Test example
1. Pharmacological tests prove that the traditional Chinese medicine composition has influence on a rat gastritis model.
1. Sample preparation
(1) Taking the granules prepared from the traditional Chinese medicine compositions in the embodiment 1 and the embodiment 5 respectively, and preparing the granules into high, medium and low dose groups with the concentration of 26g crude drug/mL, 13g crude drug/mL and 6.5g crude drug/mL by using distilled water respectively;
(2) Taking the granules prepared from the traditional Chinese medicine compositions in the comparative examples 1-13, and preparing the granules into solutions with the concentration of 13g crude drugs/mL by using distilled water respectively;
(3) Taking granules prepared from the Chinese medicinal composition of the relevant formula of the comparative examples 14-19, and preparing into solutions with the concentration of 13g crude drugs/mL by using distilled water respectively.
2. Grouping and administration of drugs
(1) Protective effect on acute gastritis of rats
Taking a plurality of SD rats with half male and half female, the weight of 200g-230g, and 10 rats in each group, wherein:
1.2 and 3, respectively intragastric administration: in example 5 of the invention, the granules have high, medium and low dosages (26 g crude drug/kg, 13g crude drug/kg, 6.5g crude drug/kg);
4. and 5, respectively intragastric administration of 6 groups: the granules in the embodiment 1 of the invention have high, medium and low dosages (26 g crude drug/kg, 13g crude drug/kg, 6.5g crude drug/kg); positive control: positive control drug gastric juice granule (1.35 g/kg);
7. 8 groups are respectively the control group (13 g/kg) of the decoction of the embodiment 1 and the embodiment 5;
9 model control groups: distilled water;
and (3) intragastric administration of 10-22 groups: granule solutions of comparative examples 1-13 (13 g crude drug/kg);
and 23-28 groups of the medicinal materials are respectively irrigated with stomach: comparative examples 14-19 prescription (13 g crude drug/kg).
For 7 days, 1 time per day, rats are fasted for 24 hours before the last administration, water is freely drunk, after 90min of the last administration, the rats are gavaged with 2 mL/mouse of 15% ethanol, and the rats are killed after 4 hours and the degree of gastric mucosal injury is observed. The lesions were expressed as ulcer indexes, and the ulcer inhibition ratios were calculated as the ulcer indexes in millimeters of the sum of the lengths of the ulcers, and the results are shown in tables 1 and 2.
Table 1 results of the effects of example 1 and comparative examples 1 to 13 on rat acute gastritis model: (n=10)
Group of | Dosage (g/kg) | Ulcer index (mm) | Inhibition ratio (%) |
Model control group | Distilled water | 31.80±8.36 | / |
Control group of Weisu granule | 1.35 | 24.70±5.44* | 22.33 |
Example 1 decoction control group | 13 | 25.43±4.89 | 20.03 |
Example 1 high dose | 26 | 26.36±5.97 | 17.11 |
Dosage in example 1 | 13 | 26.71±5.04 | 16.01 |
Example 1 Low dose | 6.5 | 27.29±4.79 | 14.18 |
Comparative example 1 | 13 | 27.44±6.13 | 13.71 |
Comparative example 2 | 13 | 27.24±5.97 | 14.34 |
Comparative example 3 | 13 | 26.01±5.11 | 18.21 |
Comparative example 4 | 13 | 26.24±6.03 | 17.48 |
Comparative example 5 | 13 | 27.05±5.71 | 14.94 |
Comparative example 6 | 13 | 26.89±5.29 | 15.44 |
Comparative example 7 | 13 | 26.44±5.13 | 16.86 |
Comparative example 8 | 13 | 27.12±5.42 | 14.72 |
Comparative example 9 | 13 | 26.30±5.22 | 17.30 |
Comparative example 10 | 13 | 27.04±5.03 | 14.97 |
Comparative example 11 | 13 | 27.05±5.41 | 14.94 |
Comparative example 12 | 13 | 26.71±5.38 | 16.01 |
Comparative example 13 | 13 | 27.04±6.13 | 14.97 |
Table 2 example 5 and comparative examples 14-19 acute treatment of ratsEffect of the model of sexual gastritis: (n=10)
Group of | Dosage (g/kg) | Ulcer index (mm) | Inhibition ratio (%) |
Model control group | Distilled water | 31.80±8.36 | / |
Control group of Weisu granule | 1.35 | 24.70±5.44* | 22.33 |
Example 5 decoction control group | 13 | 25.20±6.27* | 20.75 |
Example 5 high dose | 26 | 22.50±6.60** | 29.25 |
Examples5 dosage | 13 | 24.30±7.59* | 23.58 |
Example 5 Low dose | 6.5 | 28.80±5.63 | 9.43 |
Comparative example 14 | 13 | 26.34±5.07 | 17.17 |
Comparative example 15 | 13 | 26.04±6.03 | 18.11 |
Comparative example 16 | 13 | 26.35±5.47 | 17.14 |
Comparative example 17 | 13 | 26.89±5.29 | 15.44 |
Comparative example 18 | 13 | 27.44±6.13 | 13.71 |
Comparative example 19 | 13 | 28.22±6.07 | 11.26 |
Note: p <0.05 compared to model control; * P <0.01;
in tables 1 and 2, the inhibition rate = (ulcer index of model group-ulcer index of drug treatment group)/ulcer index of model group × 100%.
As can be seen from the test results in tables 1 and 2, compared with the model group, the high and medium dose groups of the pharmaceutical composition granules can obviously reduce the ulcer index of rats, the difference is significant, the low dose group has no obvious effect (P < 0.01), the effect is similar to that of the positive medicine stomach Su granules, the stomach Su granules are dose-dependent, and no obvious statistical difference exists for improving the physique. All the components of the splitting formula have improvement effect on the two aspects, but the statistical difference does not exist, which indicates that the effect of the splitting formula is obviously inferior to that of the whole formula.
(2) Protective effect on chronic gastritis of rats
A plurality of SD rats are selected, the male and female rats are not limited, the weight of the SD rats is 200g-230g, and 10 normal groups drink distilled water. The rest rats are subjected to intragastric administration of 2 mL/mouse 60% ethanol solution every 5 days and 31-60 days every 7 days on the 1 st-30 th days of molding, and 20mmol/L sodium deoxycholate solution is used as drinking water for drinking at will. On the 60 th to 90 th days, 30 percent ethanol solution and 20mmol/L sodium deoxycholate solution are respectively used for changing every 3 days to be used as drinking water for random drinking.
The rats surviving after model building are randomly grouped (10 rats in each group) into a model control group (distilled water), a positive control group (gastric threonine granules), an example 1 decoction control group (13 g/kg) and an example 1 high dose group (26 g/kg), an example 1 medium dose group (13 g/kg), an example 1 low dose group (6.5 g/kg), comparative examples 1-13 (13 g crude drug/kg), an example 5 decoction control group (13 g/kg) and an example 5 high dose group (26 g/kg), an example 5 medium dose group (13 g/kg), an example 5 low dose group (6.5 g/kg) and comparative examples 14-19 (13 g crude drug/kg). Wherein the model group and the normal group are administered with distilled water of equal volume, and are administered for 7 days by regular drenching for 1 time each day; rats were sacrificed 1 hour after the last dose. Detecting gastric acidity and pepsin activity, fixing gastric tissues with 10% formaldehyde, performing HE staining, observing the thickness of a pyloric part and a gastric fundus mucosa glandular layer and a muscular layer of each HE staining piece by means of a micrometer under a microscope, calculating the average of the thickness of each mucosal glandular layer (L1) and muscular layer (L2), comparing the average to obtain L1/L2, measuring the number of mucosa-inherent glands with the length of 2mm by using the micrometer between 200-1200 mu m away from the junction of the pyloric ring, the forestomach and the glandular stomach, taking any two visual fields, and averaging to obtain the gland density (unit: per mm).
After the animal is subjected to last administration, the animal is killed, serum is collected, SOD and GSH-Px activity in the serum is measured according to the kit instructions, stomach tissues are taken and prepared into 10 percent homogenate, and the MDA content is measured according to the kit instructions. The results are shown in tables 3 to 8.
Table 3 effect of example 1 and comparative examples 1-13 on gastric juice composition in chronic gastritis rat (X ± S, n = 10)
Group of | Dosage (g/kg) | Gastric acidity value (mmol/L) | Pepsin Activity (U) |
Normal group | 13 | 10.01±2.21 | 169.17±51.05 |
Model control group | Distilled water | 6.83±1.12 △△ | 130.64±32.19 △ |
Control group of Weisu granule | 1.35 | 7.65±1.49 | 138.62±37.38 |
Example 1 decoction control group | 13 | 7.92±1.61 | 142.34±32.59 |
Example 1 high dose | 26 | 7.27±1.12 | 136.27±34.64 |
Dosage in example 1 | 13 | 7.53±1.82 | 137.05±35.02 |
Example 1 Low dose | 6.5 | 7.14±1.34 | 131.47±36.22 |
Comparative example 1 | 13 | 7.54±1.07 | 134.14±33.57 |
Comparative example 2 | 13 | 7.27±1.44 | 135.08±36.50 |
Comparative example 3 | 13 | 7.52±1.83 | 137.22±35.46 |
Comparative example 4 | 13 | 7.47±1.62 | 134.80±33.07 |
Comparative example 5 | 13 | 7.22±1.56 | 135.24±35.02 |
Comparative example 6 | 13 | 7.15±1.42 | 136.11±29.98 |
Comparative example 7 | 13 | 7.40±1.53 | 134.28±31.57 |
Comparative example 8 | 13 | 7.33±1.62 | 133.82±29.02 |
Comparative example 9 | 13 | 7.15±1.90 | 135.07±32.67 |
Comparative example 10 | 13 | 7.27±1.88 | 134.55±33.24 |
Comparative example 11 | 13 | 7.37±1.22 | 135.22±34.50 |
Comparative example 12 | 13 | 7.05±1.57 | 134.92±35.89 |
Comparative example 13 | 13 | 7.28±1.44 | 133.08±33.27 |
Table 4 effects of example 1 and comparative examples 1-13 on SOD, GSH-Px activity and MDA content in chronic gastritis rats (X ± S, n = 10)
TABLE 5 Effect of example 1 and comparative examples 1-13 on gastric mucosal morphology index in rats with chronic gastritis (X + -S, n = 10)
Table 6 effects of example 5 and comparative examples 14-19 on gastric juice composition in chronic gastritis rats: (n=10)
Group of | Dosage (g/kg) | Gastric acidity value (mmol/L) | Pepsin Activity (U) |
Normal group | 13 | 10.01±2.21 | 169.17±51.05 |
Model control group | Distilled water | 6.83±1.12 △△ | 130.64±32.19 △ |
Control group of Weisu granule | 1.35 | 7.65±1.49 | 138.62±37.38 |
Example 5 decoction control group | 13 | 8.38±1.64* | 140.69±33.55 |
EXAMPLE 5 high dose | 26 | 8.43±1.73* | 134.85±55.12 |
Dosage in example 5 | 13 | 8.48±1.67* | 148.78±48.49 |
Example 5 Low dose | 6.5 | 7.89±1.42 | 137.90±38.88 |
Comparative example 14 Red peony and licorice root drug combination | 13 | 7.99±1.49 | 139.24±37.22 |
Comparative example 15 rhizoma Atractylodis and pericarpium Citri Tangerinae drug combination | 13 | 8.12±1.51 | 136.88±38.34 |
Comparative example 16 lack rhizoma Atractylodis and herba Agastaches medicinal group | 13 | 8.24±1.66 | 142.01±37.16 |
Comparative example 17 rhizoma Atractylodis and ginger processed pinellia Tuber lacking medicinal group | 13 | 7.98±1.43 | 138.55±39.56 |
Comparative example 18 Magnolia officinalis and Citrus reticulata blanco medicinal group | 13 | 8.07±1.58 | 134.09±42.06 |
Comparative example 19 common bletilla pseudobulb and cuttlebone medicine group | 13 | 8.28±1.62 | 137.11±39.07 |
Note: in comparison with the normal group, △ P<0.05; △△ P<0.01; p compared to model control group<0.05
TABLE 7 Effect of example 5 and comparative examples 14-19 on SOD, GSH-Px Activity and MDA content in rats with chronic gastritis: (n=10)
Note: in comparison with the normal group, △ P<0.05; △△ P<0.01; p compared to model control group<0.05;**P<0.01
Table 8 effect of example 5 and comparative examples 14-19 on gastric mucosal morphology index (X ± S, n = 10) in rats with chronic gastritis
Note: in comparison with the normal group, △△ P<0.01; p compared to model control group<0.05;**P<0.01
According to the test results in tables 3-5, the important composition in the invention has an ideal effect on chronic gastritis according to the compatibility principle of 'monarch, minister, assistant and guide' and the synergistic or shared effect among the components; as can be seen from the test results in tables 6 to 8, the total gastric acidity and pepsin activity of rats in example 5 are significantly reduced compared with the normal group, which indicates that the high and medium dose groups of the Chinese medicinal composition prepared in example 5 can significantly inhibit the reduction of gastric acidity; but has no obvious influence on the activity of the gastric juice protease; the high, medium and low dose groups of the particles of the traditional Chinese medicine composition prepared in the embodiment 5 can obviously improve the activities of SOD and GSH-Px in serum and reduce the content of MDA in stomach tissues; in comparison examples 14-19, the formula after the formula splitting has improved the above two aspects, but there is no statistical difference, which indicates that the effect of the formula splitting group is obviously inferior to that of the whole group.
The above tests of the Chinese medicinal composition granules in other examples show that the effect of the granules is similar to that of the Chinese medicinal composition in example 5 of the invention, and the obvious difference is not generated (P is less than 0.05).
The results show that different formulas and high, medium and low dose groups of the granules of the pharmaceutical composition can obviously improve the effect of acute and chronic gastritis, particularly the effect of chronic gastritis is ideal, but the effect of the formula splitting group is obviously inferior to that of the whole formula.
The experimental result shows that the high, medium and low dose groups of the pharmaceutical composition granule can obviously increase the activities of SOD and GSH-Px in rat serum and reduce the content of MDA in stomach tissues, which indicates that the pharmaceutical composition granule has better antioxidation and the action is better than that of a positive control group (stomach Su granule).
The experimental result shows that the content of PGE2 in the stomach tissue of the rat with bile reflux gastritis can be obviously increased by the high and medium dose groups of the medicinal composition particles, the content is consistent with the pathological examination result, and the effect of the positive control group (gastric perilla particles) is not obvious.
Fig. 1 to 4 show the pathological graphs of the normal group, the model group, the positive group and the decoction group of example 5, respectively, and fig. 5 to 6 show the pathological graphs of the effect of the traditional Chinese medicine composition of example 5 and comparative examples 14 to 19 on the gastric mucosa tissue of rats with chronic gastritis, as shown in fig. 5 and 6. As can be seen from the figure, the normal group of rats has normal gastric mucosal tissue structure, intact mucosal epithelium, and normal size, shape, structure and distribution of most glands, and has no other pathological changes such as gland hyperplasia, congestion, hemorrhage, edema, degeneration, erosion, necrosis, intestinal metaplasia, fibrous tissue hyperplasia, lymphocyte and plasma cell infiltration; the pathological changes of the tissue structure of the mucous membrane of the rat stomach body are serious, the mucous membrane epithelium is desquamated focally, the mild erosion, the light and moderate gland hyperplasia are accompanied, the tissue structure of the inherent membrane is basically clear, the mild edema is caused, and the infiltration of the lymphocyte and the plasma cell is obvious; the positive medicine group rat stomach mucosa tissue structure is obviously improved and basically tends to be normal, the mucosa epithelium is complete, the gland hyperplasia and erosion are obviously improved, the inherent membrane tissue structure is basically clear, but slight lymphocyte and plasma cell infiltration still exists.
In the groups of example 5 and comparative examples 14-19, the structure of the mucous membrane tissue of the stomach of the rat is normal, the pathological improvement is obvious, the mucous membrane epithelium is complete, the hyperplastic gland is obviously improved, the infiltration of lymphocytes and plasma cells is less, but congestion, bleeding, degeneration, erosion, necrosis, intestinal metaplasia, fibrous tissue hyperplasia and other pathological changes are not seen, which shows that the composition has obvious curative effect on improving the pathological changes of the mucous membrane of the stomach.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (6)
1. A traditional Chinese medicine composition for treating chronic superficial gastritis is characterized by being prepared from the following raw materials in parts by weight: 10 parts of rhizoma atractylodis, 10 parts of wrinkled gianthyssop herb, 10 parts of mangnolia officinalis, 10 parts of dried orange peel, 10 parts of artemisia capillaries, 2 parts of rhizoma coptidis from rhizomes, 7 parts of rhizoma acori graminei, 19 parts of red paeony roots, 19 parts of rhizoma phragmitis, 3 parts of round cardamom, 11 parts of cuttlebone, 14 parts of rhizoma bletillae, 5 parts of rhizoma pinelliae from rhizomes and 4 parts of liquorice;
or 12 parts of rhizoma atractylodis, 12 parts of wrinkled gianthyssop herb, 11 parts of mangnolia officinalis, 12 parts of dried orange peel, 12 parts of artemisia capillaries, 3 parts of rhizoma coptidis from rhizomes, 9 parts of rhizoma acori graminei, 21 parts of red paeony roots, 21 parts of rhizoma phragmitis, 5 parts of round cardamom, 13 parts of cuttlebone, 16 parts of rhizoma bletillae, 7 parts of rhizoma pinelliae from rhizomes and 6 parts of liquorice;
or 15 parts of rhizoma atractylodis, 14 parts of agastache rugosus, 14 parts of mangnolia officinalis, 14 parts of dried orange peel, 14 parts of artemisia capillaries, 5 parts of rhizoma zingiberis, 10 parts of rhizoma acori graminei, 23 parts of red paeony root, 23 parts of rhizoma phragmitis, 6 parts of round cardamom, 15 parts of cuttlebone, 18 parts of rhizoma bletillae, 9 parts of rhizoma pinelliae preparata and 8 parts of liquorice.
2. The traditional Chinese medicine composition for treating chronic superficial gastritis as claimed in claim 1, wherein the traditional Chinese medicine composition is in any pharmaceutically acceptable dosage form.
3. The traditional Chinese medicine composition for treating chronic superficial gastritis as claimed in claim 2, wherein the pharmaceutically acceptable dosage form is granules, oral solutions, tablets, capsules or pills.
4. A method of preparing the Chinese medicinal composition for treating chronic superficial gastritis as claimed in claim 1, comprising the steps of:
a) Extracting cortex Magnolia officinalis with 8-12 times of 60-80% ethanol for 1-3 times (each for 1-3 hr), filtering, mixing filtrates, recovering ethanol, concentrating, and lyophilizing at-80 deg.C to-60 deg.C to obtain dry extract;
b) Soaking rhizoma Atractylodis, herba Agastaches, pericarpium Citri Tangerinae, rhizoma Acori Graminei and fructus Amomi rotundus in water for 1-3 hr, extracting volatile oil by steam distillation for 2-6 hr, and collecting volatile oil; collecting the distilled water solution in another container;
c) Mixing the volatile oil-extracted raw materials with the rest raw materials, decocting in water for 2-5 times (each for 1-3 hr), filtering, and mixing with the volatile oil-extracted water solution to obtain extractive solution;
d) Concentrating the extracting solution to the relative density of 1.10-1.20 at 60 ℃ to obtain a concentrated solution;
e) Mixing the concentrated solution obtained in the step D) with ethanol until the alcohol content is 65% -75%, and carrying out alcohol precipitation to obtain alcohol precipitation supernatant;
f) Concentrating the alcohol precipitation supernatant to 60 ℃ relative density of 1.25-1.35 to obtain concentrated solution again;
g) Freeze drying the concentrated solution obtained in the step F) at minus 80 ℃ to minus 60 ℃ to obtain a water extraction and alcohol precipitation traditional Chinese medicine composition;
h) The collected volatile oil is included by a water saturation method;
i) Crushing the dry paste obtained in the step A) and the step G), and uniformly mixing the crushed dry paste with the volatile oil inclusion compound obtained in the step H) to obtain the traditional Chinese medicine composition.
5. The method of claim 4, wherein the time period for extracting volatile oil in step B) is 5 hours.
6. The method of claim 4, wherein the concentration temperature of step D) is 55-65 ℃.
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