CN104474201A - A kind of pharmaceutical composition for treating stomach disease and preparation method thereof - Google Patents

Abstract

A pharmaceutical composition for treating gastropathy and its preparation method, through extracting its effective constituent to radix astragali, radix Acanthopanacis Senticosi, Crataegus oxyacantha of gastropathy, concentrate and extract, add the powder of medicament with stomach nourishing and stomach protecting in order to strengthen its therapeutic effect, can reach the same effect with compound western medicine preparation for treating gastropathy, and avoid taking western medicine and causing the too strong oxic side effect to the human body, let patient get rid of the relief of gastropathy as early as possible, and avoid the secondary injury of the oxic side effect.

Description

A kind of pharmaceutical composition for treating stomach disease and preparation method thereof

technical field

The invention relates to the technical field of medicines, in particular to a pharmaceutical composition for treating stomach diseases and a preparation method thereof.

Background technique

Stomach disease is a common disease. Stressful work, study, bad eating habits (such as alcoholism, overeating, partial eclipse, irregular diet, and eating too much irritating food), drug stimulation, and bacterial infection may cause stress in the stomach. The irritative reaction damages the gastric mucosa, leading to a series of symptoms such as acute and chronic gastritis, gastric ulcer, duodenal ulcer, gastric polyps, and gastric mucosal prolapse. Induce gastric cancer, gastric cancer and other serious diseases.

Due to the tension of life and the pressure of work, many patients with stomach problems take compound western medicine preparations such as gastric motility drugs, aluminum-containing preparations, gastric mucosal protective agents, bismuth preparations, etc., in order to see curative effect in a short time. It acts quickly and can suppress the onset of stomach problems in a short time, but it is difficult to cure the root cause, and these drugs have side effects in varying degrees. After being absorbed by the human body, they will affect the liver, kidney, spleen, brain, bones and other organs and tissues to cause varying degrees of damage. ; Although the degree of side effects of using traditional Chinese medicine to treat stomach disease is small, there are slow effects and inconvenient characteristics to take.

Contents of the invention

The object of the present invention is to provide a pharmaceutical composition for treating stomach diseases and its preparation method. By extracting the active ingredients of Astragalus, Acanthopanax, and Hawthorn for stomach diseases, and carrying out concentrated extraction, then adding stomach-nourishing and stomach-protecting ingredients The drug powder can enhance its therapeutic effect, which can achieve the same effect as the compound western medicine preparation for treating stomach diseases, and avoid excessive toxic and side effects on the human body caused by taking western medicine, so that patients can get rid of the torment of stomach diseases as soon as possible, and avoid the secondary effects of toxic and side effects harm.

In order to solve the problems of the technologies described above, the present invention takes the following technical solutions:

A pharmaceutical composition for treating stomach diseases and a preparation method thereof, which are made of the following materials in proportion by weight:

20-25 parts of glycosides, 10-12 parts of yam, 5-7 parts of Xu Changqing, 5-7 parts of Divine Comedy, 4-6 parts of rhubarb, 3-5 parts of Codonopsis, 3-5 parts of Atractylodes macrocephala, 3-5 parts of licorice, 4-6 parts of rhubarb.

The glycoside compound is prepared by extracting Astragalus, Acanthopanax and Hawthorn according to the weight ratio of 20-25:30-40:10-15.

A pharmaceutical composition for treating stomach diseases and a preparation method thereof, comprising the following steps:

Step 1: Take Astragalus, Acanthopanax, and Hawthorn, wash, dry, crush and mix, and extract 2-3 times with 8-10 times the amount of aqueous ethanol with a concentration of 50%-70%, 3-3 times each time After 4 hours, the extract was filtered, and the combined filtrate was concentrated under reduced pressure until there was no ethanol smell, then passed through a macroporous adsorption resin, and eluted with a gradient of 50%-70% aqueous ethanol for 5 times the column volume, and then concentrated under reduced pressure again to No ethanol smell, then add alkaline solution, adjust pH to 9-10, react at 35-40°C for 8-10 hours, add acidic solution to adjust pH to 6.8-7.2, add n-butanol for extraction, collect organic phase and polymerize The amide column was subjected to chromatographic separation, followed by gradient elution with 50%-70% aqueous ethanol, concentrated under reduced pressure to a relative density of 1.2, then added ethyl acetate for extraction, collected the aqueous phase and concentrated it to a relative density of 1.3, After standing still, the precipitate is completely filtered, and the filter cake is washed with water, and then recrystallized with methanol to obtain the glycoside compound with the above components as powder.

The pulverization described in this step is to pulverize Astragalus, Acanthopanax, and Hawthorn and pass through a 20-mesh sieve.

The alkaline solution described in this step is a sodium hydroxide or potassium hydroxide solution with a mass concentration of 2%.

The acidic solution described in this step is dilute sulfuric acid or dilute hydrochloric acid with a mass concentration of 4.

The washing with water described in this step is to use deionized water for washing.

Step 2: Grinding the remaining materials and mixing them evenly with glycoside compound powder to obtain the pharmaceutical composition for treating stomach diseases.

The pulverization described in this step is to pulverize the remaining materials through a 200-mesh sieve.

Preferably, those skilled in the art can add pharmaceutically acceptable adjuvants or auxiliary components to the present invention to prepare pharmaceutically commonly used drugs, such as tablets, capsules, granules, oral liquids, and dripping pills, according to what they have learned. and other drugs.

The benefit of the present invention is that astragaloside IV in Astragalus membranaceus is combined with hyperoside in Acanthopanax and hawthorn, and while extracting astragaloside IV and hyperoside as much as possible, combined Rough extraction can reduce unnecessary operation procedures; at the same time, the rest of the drugs that are effective for stomach diseases and nourish the stomach are crushed and mixed with glycosides, which can improve the efficacy of glycosides in treating stomach diseases and maintaining the stomach.

Detailed ways

The invention discloses a pharmaceutical composition for treating stomach diseases and a preparation method thereof. Those skilled in the art can refer to the content of this article and appropriately modify process parameters to realize the preparation of the product. In particular, it should be pointed out that all similar replacements and modifications that are obvious to those skilled in the art are deemed to be included in the present invention. The pharmaceutical composition for treating stomach disease of the present invention and its preparation method have been described in preferred embodiments, and relevant personnel can obviously understand the method and application described herein without departing from the content, spirit and scope of the present invention. Make changes or appropriate changes and combinations to realize and apply the technology of the present invention.

Unless otherwise specified, the test materials involved in the specific embodiments can be purchased freely from the market.

The present invention is specifically described below in conjunction with embodiment:

Example 1

A pharmaceutical composition for treating stomach diseases, made of the following materials in proportion by weight:

20 parts of glycosides, 10 parts of yam, 5 parts of Xu Changqing, 5 parts of Divine Comedy, 4 parts of rhubarb, 3 parts of Codonopsis pilosula, 3 parts of Atractylodes macrocephala, 3 parts of licorice, and 4 parts of rhubarb.

The glycoside compound is prepared by extracting Astragalus, Acanthopanax and Hawthorn in a weight ratio of 20:30:10.

A pharmaceutical composition for treating stomach diseases and a preparation method thereof, comprising the following steps:

Step 1: Take Astragalus, Acanthopanax, and Hawthorn, wash, dry, crush and mix, and extract twice with 8 times the amount of 50% aqueous ethanol, 3 hours each time, filter the extract, and combine The filtrate was concentrated under reduced pressure until there was no ethanol smell, then passed through a macroporous adsorption resin, and eluted with a gradient of 50% aqueous ethanol for 5 times the column volume, and then concentrated under reduced pressure again until there was no ethanol smell, and then an alkaline solution was added to adjust the pH to 9, after reacting at 35°C for 8 hours, adding an acidic solution to adjust the pH to 6.8, adding n-butanol for extraction, collecting the organic phase through a polyamide column for chromatographic separation, and then using 50% aqueous ethanol for gradient elution. Concentrate under reduced pressure to a relative density of 1.2, then add ethyl acetate for extraction, collect the water phase and concentrate to a relative density of 1.3, after standing still, filter the precipitate completely, wash the filter cake with water, and recrystallize it with methanol, The obtained powder is the glycoside compound of the above composition.

The pulverization described in this step is to pulverize Astragalus, Acanthopanax, and Hawthorn and pass through a 20-mesh sieve.

The alkaline solution described in this step is a sodium hydroxide or potassium hydroxide solution with a mass concentration of 2%.

The acidic solution described in this step is dilute sulfuric acid or dilute hydrochloric acid with a mass concentration of 4.

The washing with water described in this step is to use deionized water for washing.

Step 2: Grinding the remaining materials and mixing them evenly with glycoside compound powder to obtain the pharmaceutical composition for treating stomach diseases.

The pulverization described in this step is to pulverize the remaining materials through a 200-mesh sieve.

Preferably, those skilled in the art can add pharmaceutically acceptable adjuvants or auxiliary components to the present invention to prepare pharmaceutically commonly used drugs, such as tablets, capsules, granules, oral liquids, and dripping pills, according to what they have learned. and other drugs.

Example 2

A pharmaceutical composition for treating stomach diseases, made of the following materials in proportion by weight:

23 parts of glycosides, 11 parts of yam, 6 parts of Xu Changqing, 6 parts of Shenqu, 5 parts of rhubarb, 4 parts of Codonopsis pilosula, 4 parts of Atractylodes macrocephala, 4 parts of licorice, and 5 parts of rhubarb.

The glycoside compound is prepared by extracting Astragalus, Acanthopanax and Hawthorn according to the weight ratio of 23:35:13.

A pharmaceutical composition for treating stomach diseases and a preparation method thereof, comprising the following steps:

Step 1: Take Astragalus, Acanthopanax, and Hawthorn, wash, dry, crush and mix, use 9 times the amount of water-containing ethanol with a concentration of 60% to reflux extract 3 times, each time for 3.5 hours, filter the extract, and combine The filtrate was concentrated under reduced pressure until there was no ethanol smell, then passed through a macroporous adsorption resin, and eluted with a gradient of 60% aqueous ethanol for 5 times the column volume, and then concentrated under reduced pressure again until there was no ethanol smell, and then an alkaline solution was added to adjust the pH to 9.5, react at 38°C for 9 hours, add an acidic solution to adjust the pH to 7, add n-butanol for extraction, collect the organic phase and carry out chromatography on a polyamide column, and then use 60% aqueous ethanol for gradient elution. Concentrate under reduced pressure to a relative density of 1.2, then add ethyl acetate for extraction, collect the water phase and concentrate to a relative density of 1.3, after standing still, filter the precipitate completely, wash the filter cake with water, and recrystallize it with methanol, The obtained powder is the glycoside compound of the above composition.

The pulverization described in this step is to pulverize Astragalus, Acanthopanax, and Hawthorn and pass through a 20-mesh sieve.

The alkaline solution described in this step is a sodium hydroxide or potassium hydroxide solution with a mass concentration of 2%.

The acidic solution described in this step is dilute sulfuric acid or dilute hydrochloric acid with a mass concentration of 4.

The washing with water described in this step is to use deionized water for washing.

Step 2: Grinding the remaining materials and mixing them evenly with glycoside compound powder to obtain the pharmaceutical composition for treating stomach diseases.

The pulverization described in this step is to pulverize the remaining materials through a 200-mesh sieve.

Preferably, those skilled in the art can add pharmaceutically acceptable adjuvants or auxiliary components to the present invention to prepare pharmaceutically commonly used drugs, such as tablets, capsules, granules, oral liquids, and dripping pills, according to what they have learned. and other drugs.

Example 3

A pharmaceutical composition for treating stomach diseases and a preparation method thereof, which are made of the following materials in proportion by weight:

25 parts of glycosides, 12 parts of yam, 7 parts of Xu Changqing, 7 parts of Divine Comedy, 6 parts of rhubarb, 5 parts of Codonopsis, 5 parts of Atractylodes macrocephala, 5 parts of licorice, and 6 parts of rhubarb.

The glycoside compound is prepared by extracting Astragalus, Acanthopanax and Hawthorn in a weight ratio of 25:40:15.

A pharmaceutical composition for treating stomach diseases and a preparation method thereof, comprising the following steps:

Step 1: Take Astragalus, Acanthopanax, and Hawthorn, wash, dry, crush and mix, and extract 3 times with 10 times the amount of 70% aqueous ethanol, 4 hours each time, filter the extract, and combine The filtrate was concentrated under reduced pressure until there was no ethanol smell, then passed through a macroporous adsorption resin, and eluted with a gradient of 70% aqueous ethanol for 5 times the column volume, and then concentrated under reduced pressure again until there was no ethanol smell, and then an alkaline solution was added to adjust the pH To 9-10, react at 40°C for 10 hours, add acidic solution to adjust the pH to 7.2, add n-butanol for extraction, collect the organic phase and separate it by polyamide column chromatography, and then use 70% aqueous ethanol for gradient elution , concentrated under reduced pressure to a relative density of 1.2, then added ethyl acetate for extraction, collected the water phase and concentrated to a relative density of 1.3, and filtered the precipitate completely after standing, washed the filter cake with water, and then re-introduced it with methanol Crystallization, the powder is the glycoside compound of the above composition.

The pulverization described in this step is to pulverize Astragalus, Acanthopanax, and Hawthorn and pass through a 20-mesh sieve.

The alkaline solution described in this step is a sodium hydroxide or potassium hydroxide solution with a mass concentration of 2%.

The acidic solution described in this step is dilute sulfuric acid or dilute hydrochloric acid with a mass concentration of 4.

The washing with water described in this step is to use deionized water for washing.

Step 2: Grinding the remaining materials and mixing them evenly with glycoside compound powder to obtain the pharmaceutical composition for treating stomach diseases.

The pulverization described in this step is to pulverize the remaining materials through a 200-mesh sieve.

Preferably, those skilled in the art can add pharmaceutically acceptable adjuvants or auxiliary components to the present invention to prepare pharmaceutically commonly used drugs, such as tablets, capsules, granules, oral liquids, and dripping pills, according to what they have learned. and other drugs.

test case

Using mice as the test animals of this test example, 200 mice were selected for preliminary preparation, and the food mixed with Helicobacter pylori was used as the daily food of the mice. After the mice ate the food for 12 weeks, their food intake dropped by more than half. Among them, 100 mice with relatively similar food intake were divided into 5 groups. Each embodiment of this product and two compound western medicine gastric medicines sold on the market were mixed into the food of the mice respectively, and a comparative test was carried out. During the time period, the mice were fed with the same amount of food for 5 times, once every 4 hours, and the food consumption of the mice in each group was collected every day. After 4 weeks, a preliminary simple evaluation of the product was carried out based on the food consumption of the mice.

test case 1

In the first week of the test period, the food intake of the mice gradually increased, and the food intake returned to normal in the middle of the second week, and the food intake in the third week was the same as that before the preparation or even increased, and the food intake in the fourth week remained at the level of the third week.

test case 2

During the first week of the test period, the food intake of the mice gradually increased, and the food intake returned to normal in the second week. The food intake at the weekend of the second week was the same as that before the previous preparation or even increased, and remained at the weekend food intake level of the second week until the fourth week.

Test case 3

During the first week of the test period, the food intake of the mice gradually increased, and the food intake returned to normal in the second week. The food intake at the weekend of the second week was the same as that before the previous preparation or even increased, and remained at the weekend food intake level of the second week until the fourth week.

Compound western medicine control group 1

In the first week of the test period, the food intake of the mice gradually increased, and the food intake returned to normal in the second week, and the food intake in the third week was the same as that before the preparation or even increased, and the food intake in the fourth week remained at the level of the third week.

Compound western medicine control group 2

In the first week of the test period, the food intake of the mice gradually increased, and the food intake returned to normal in the middle of the second week, and the food intake at the weekend of the second week was the same as that before the previous preparation, or even increased, and remained at the weekend food intake level of the second week until the fourth week.

The above is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art may make changes or modifications without creative work within the technical scope disclosed in the present invention. Replacement should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be determined by the protection scope defined in the claims.

Claims (3)

1. A pharmaceutical composition for the treatment of gastropathy and preparation method thereof, is characterized in that being made by following material by weight fraction ratio: 20-25 parts of glycosides, 10-12 parts of yam, 5-7 parts of Xu Changqing, 5-7 parts of Divine Comedy, 4-6 parts of rhubarb, 3-5 parts of Codonopsis, 3-5 parts of Atractylodes macrocephala, 3-5 parts of licorice, 4-6 parts of rhubarb; it is characterized in that the glycoside compound is extracted from Astragalus, Acanthopanax and Hawthorn in a weight ratio of 20-25:30-40:10-15. 2. A pharmaceutical composition for the treatment of gastropathy and preparation method thereof, is characterized in that following steps: Step 1: Take Astragalus, Acanthopanax, and Hawthorn, wash, dry, crush and mix, and extract 2-3 times with 8-10 times the amount of aqueous ethanol with a concentration of 50%-70%, 3-3 times each time After 4 hours, the extract was filtered, and the combined filtrate was concentrated under reduced pressure until there was no ethanol smell, then passed through a macroporous adsorption resin, and eluted with a gradient of 50%-70% aqueous ethanol for 5 times the column volume, and then concentrated under reduced pressure again to No ethanol smell, then add alkaline solution, adjust pH to 9-10, react at 35-40°C for 8-10 hours, add acidic solution to adjust pH to 6.8-7.2, add n-butanol for extraction, collect organic phase and polymerize The amide column was subjected to chromatographic separation, followed by gradient elution with 50%-70% aqueous ethanol, concentrated under reduced pressure to a relative density of 1.2, then added ethyl acetate for extraction, collected the aqueous phase and concentrated it to a relative density of 1.3, After standing still, the precipitate is completely filtered, and after the filter cake is washed with water, it is recrystallized with methanol to obtain a glycoside compound whose powder is the above composition; Cross 20 mesh sieves; the alkaline solution described in this step is that mass concentration is 2% sodium hydroxide or potassium hydroxide solution; the acidic solution described in this step is dilute sulfuric acid or dilute hydrochloric acid that mass concentration is 4; this step The washing with water is to use deionized water for washing; step 2: pulverize the remaining materials and mix them evenly with the glycoside compound powder to obtain the pharmaceutical composition for treating stomach diseases; the pulverization in this step is to The remaining materials were crushed through a 200-mesh sieve. 3. a kind of pharmaceutical composition for the treatment of stomach disease as claimed in claim 2 and preparation method thereof, it is characterized in that: can add pharmaceutically acceptable adjuvant or auxiliary ingredient in described composition Commonly used drugs, such as tablets, capsules, granules, oral liquids, dripping pills and other drugs.