Preparation for preventing and treating gastric mucosal damage and application thereof

Abstract

The present invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a preparation for preventing and treating gastric mucosal damage and its application. By selecting sanguisorba officinalis, coptis root, costusroot and angelica sinensis for reasonable combination, the formula is simple and the processing is convenient, and the problems of complex components, high recurrence rate, easy induction of drug resistance and large toxic and side effects of existing drugs are solved.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a preparation for preventing and treating gastric mucosal damage and an application thereof. Background Art

[0002] The stomach is an important digestive organ for humans and animals. It is connected to the esophagus above and the duodenum below. It has the functions of storage, digestion, and absorption. Its mucosa and secreted gastric acid can also defend against the invasion of pathogens. With the development of the economy and society, gastric diseases are becoming more and more common, among which gastric mucosal damage is a common clinical phenomenon. There are many reasons for gastric mucosal damage, such as overeating, smoking and drinking, long-term consumption of hot or rough food, drug stimulation, bacterial infection, etc. Common symptoms of gastric mucosal damage include indigestion, bloating, stomach pain, acid reflux and nausea. If the damaged area is not treated for a long time, long-term stimulation will cause gastritis, gastric ulcer, gastric perforation and even cancer and other irreversible damage. It can be said that gastric mucosal damage is the "culprit" of gastric disease.

[0003] Prevention and treatment of gastric mucosal damage can be achieved by improving diet and lifestyle, and if the condition is severe, medication is required. Currently, the relevant drugs are mainly divided into two categories: gastric acid neutralizing drugs and gastric mucosal protective drugs, including alkaline antacids such as calcium carbonate and bicarbonate chloride, H2 receptor antagonists such as ranitidine and cimetidine, and proton pump inhibitors such as omeprazole. However, due to incorrect use in clinical practice, such as improper dosage, improper route of administration, arbitrary use of drugs without following doctor's orders, and long-term use, it may lead to high recurrence rate, drug resistance and various toxic side effects, such as cardiovascular disease, osteoporosis, liver and kidney damage, neurological diseases, gastrointestinal cancer, etc.

[0004] Traditional Chinese medicine contains a large number of natural active ingredients, has many pharmacological activities, has a wide range of sources, little toxicity and side effects, good efficacy, not easy to produce drug resistance and other characteristics, so the use of traditional Chinese medicine to treat gastric mucosal damage has great potential. For example, the patent with publication number CN116617346A discloses a Chinese medicine composition for treating gastric disease, which contains more than 20 Chinese medicines including costusroot, coptis root, and angelica root; the patent with publication number CN116920049B discloses a skin-regenerating oil for treating gastric ulcer, which contains more than ten Chinese medicines including burdock, angelica root, and coptis root. During processing, it needs to be sheared 3-5 times at 20000rpm by a flash extraction device, and then negative pressure is passed through a 5000 mesh sieve to remove the residue. It can be seen that the existing Chinese medicine compositions for treating gastric ulcer or gastric mucosal damage are mostly large prescriptions, the dosage-effect relationship of the taste is complex, and the processing technology has high requirements for equipment.

[0005] Therefore, exploring compound Chinese herbal preparations for the treatment of gastric mucosal injury has important guiding significance in the research of gastric mucosal injury diseases and drug development. Summary of the invention

[0006] In view of the shortcomings of the prior art, the present invention aims to provide a Chinese medicine composition for preventing and treating gastric mucosal damage and its application. By selecting appropriate medicinal flavors for reasonable combination, the problems of high recurrence rate, easy induction of drug resistance and large toxic and side effects caused by existing Western medicine treatment are solved.

[0007] To achieve the above objectives, in a first aspect, the present invention provides a preparation for preventing and treating gastric mucosal damage, characterized in that the raw materials of the preparation include Sanguisorba officinalis, Coptis chinensis, Costusroot and Angelica sinensis.

[0008] The medicinal properties, flavors, meridians and pharmacology of each Chinese medicine component of the present invention are as follows:

[0009] Sanguisorba officinalis: It has a slightly cold nature, tastes bitter and sour; it enters the liver and large intestine meridians; it has the effects of cooling blood and stopping bleeding, clearing away heat and detoxifying, reducing swelling and healing sores; it is mainly used to treat various bleeding syndromes, especially bloody stools and bloody dysentery due to blood heat in the lower abdomen; modern pharmacological research has shown that Sanguisorba officinalis has the effects of stopping bleeding and coagulating blood, suppressing inflammation and killing bacteria, anti-oxidation, and anti-tumor.

[0010] Coptis chinensis: bitter in nature and flavor; cold; enters the heart, liver, stomach, and large intestine meridians; has the effects of clearing away heat and dampness, clearing the heart and purging fire, clearing heat and detoxifying; mainly treats symptoms of damp-heat stagnation in the stomach and intestines; modern pharmacological research has shown that Coptis chinensis has broad-spectrum anti-inflammatory, antioxidant, and cerebral ischemia inhibition effects.

[0011] Costus root: It has a warm nature, spicy and bitter taste; it enters the gallbladder, stomach, large intestine, triple burner, and lung meridians; it has the effects of promoting qi and relieving pain, strengthening the spleen and digesting food; modern pharmacological research has shown that costus root has anti-tumor, anti-inflammatory, and therapeutic effects on loss of appetite, abdominal distension and pain, and indigestion.

[0012] Angelica: It has a warm nature, sweet and spicy taste; it enters the liver, heart and spleen meridians; it has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, moistening the intestines and relieving constipation; modern pharmacological research has shown that Angelica has the effects of analgesia, anti-inflammatory, enhancing immunity, anti-tumor, and lowering blood lipids.

[0013] Furthermore, the weight proportions of the sanguisorba officinalis, coptis chinensis, costus root and angelica sinensis are 12-27 parts of sanguisorba officinalis (such as 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts), 12-27 parts of coptis chinensis (such as 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts), 12-27 parts of costus root Parts (such as 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27), 12-37 parts of Angelica sinensis (such as 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37).

[0014] Furthermore, the weight proportions of the Sanguisorba officinalis, Coptidis Root, Aucklandia Sinensis and Angelica Sinensis are 13-26 parts of Sanguisorba officinalis, 13-26 parts of Coptidis Root, 13-26 parts of Aucklandia Sinensis and 24-36 parts of Angelica Sinensis.

[0015] Furthermore, the weight proportions of the Sanguisorba officinalis, Coptidis Root, Aucklandia Sinensis and Angelica Sinensis are 15-25 parts of Sanguisorba officinalis, 15-25 parts of Coptidis Root, 15-25 parts of Aucklandia Sinensis and 25-35 parts of Angelica Sinensis.

[0016] In a second aspect, the present invention provides a method for preparing the preparation of the first aspect, the preparation method comprising the steps of weighing raw materials, decocting, filtering and concentrating the filtrate.

[0017] Furthermore, a soaking step is included before decocting.

[0018] Furthermore, the solvent for soaking and / or decocting is water.

[0019] Furthermore, the decoction is performed once, twice or three times.

[0020] Furthermore, the concentration is concentration under reduced pressure.

[0021] Furthermore, it is concentrated to a concentration of 0.3-0.5 g / mL, preferably 0.4 g / mL.

[0022] In a third aspect, the present invention provides a composition comprising the preparation described in the first aspect.

[0023] In a fourth aspect, the present invention provides use of the preparation described in the first aspect or the composition described in the third aspect in the preparation of a product for preventing and treating gastric mucosal injury and diseases related to gastric mucosal injury.

[0024] Furthermore, the application includes at least one of the following:

[0025] (1) Application in the preparation of products for reducing gastric mucosal injury index;

[0026] (2) Application in the preparation of products for improving the inhibition rate of gastric mucosal damage.

[0027] Furthermore, the gastric mucosal damage-related disease includes at least one of gastric ulcer, acute gastritis, and chronic gastritis.

[0028] Furthermore, the product is a medicine, a feed additive or a feed.

[0029] Compared with the prior art, the present invention has the following advantages:

[0030] (1) The compound preparation of the present invention overcomes the problems of high recurrence rate, easy induction of drug resistance and large toxic side effects when using Western medicine to treat gastric mucosal damage in the prior art. It can effectively reduce the gastric mucosal damage index and increase the gastric mucosal damage inhibition rate, and has achieved excellent results in preventing and treating gastric mucosal damage.

[0031] (2) The combination of medicinal materials in the compound preparation of the present invention is reasonable. Not only is the formula simple, but it also effectively utilizes the characteristics of Sanguisorba officinalis, Coptis chinensis, Aucklandia lappa and Angelica sinensis, and exerts the synergistic effect between the various medicinal flavors.

[0032] (3) The dosage of each medicinal material in the compound preparation of the present invention is reasonable, which promotes the further full play of the efficacy of each component and promotes the synergistic effect between the medicinal materials to achieve the best efficacy.

[0033] (4) The raw materials of the compound preparation of the present invention are easily available, low in cost, and have good effects, and are suitable for wide use. The processing steps are simple, and the compound preparation has potential application value in preventing and treating gastric mucosal damage and preventing and treating diseases related to gastric mucosal damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 Shown are the gastric mucosal lesions of mice in each group.

[0035] Figure 2 Shown is the gastric mucosal injury index of mice in each group.

[0036] Figure 3 Shown is the gastric mucosal injury inhibition rate of each group of drugs. DETAILED DESCRIPTION

[0037] The following is a further description of the concept of the present invention and the technical effects produced in conjunction with specific embodiments, so as to fully understand the purpose, features and effects of the present invention. The methods are conventional methods unless otherwise specified. The materials can be obtained from public commercial channels unless otherwise specified. The illustrative embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations of the present invention. It should be noted that the embodiments of the present invention and the features in the embodiments can be combined with each other without conflict.

[0038] Example 1

[0039] Take 20g of Radix Sanguisorbae, 20g of Rhizoma Coptidis, 20g of Radix Aucklandiae, and 30g of Radix Angelicae Sinensis. Add distilled water to cover the medicinal materials for the first time and soak for 1 hour. Then boil over high heat. After boiling, filter with 3 layers of gauze to remove the residue and collect the liquid. Add distilled water to cover the medicinal materials for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate under reduced pressure to a concentration of 0.4g / mL using a rotary evaporator.

[0040] Example 2

[0041] Take 25g of Radix Sanguisorbae, 15g of Rhizoma Coptidis, 25g of Radix Aucklandiae, and 25g of Radix Angelicae Sinensis. Add distilled water to cover the medicinal materials for the first time and soak for 1 hour. Then boil over high heat. After boiling, filter with 3 layers of gauze to remove the residue and collect the liquid. Add distilled water to cover the medicinal materials for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate under reduced pressure to a concentration of 0.4g / mL using a rotary evaporator.

[0042] Example 3

[0043] Take 15g of Radix Sanguisorbae, 25g of Rhizoma Coptidis, 15g of Radix Aucklandiae, and 35g of Radix Angelicae Sinensis. Add distilled water to cover the medicinal materials for the first time and soak for 1 hour. Then boil over high heat. After boiling, filter with 3 layers of gauze to remove the residue and collect the liquid. Add distilled water to cover the medicinal materials for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate under reduced pressure to a concentration of 0.4g / mL using a rotary evaporator.

[0044] Comparative Example 1

[0045] Take 90g of Sanguisorba officinalis, add distilled water to cover the medicinal material for the first time, soak for 1 hour, and then boil over high heat. After boiling, filter with 3 layers of gauze to remove the residue and collect the liquid. Add distilled water to cover the medicinal material for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate under reduced pressure using a rotary evaporator to a concentration of 0.4 g / mL.

[0046] Comparative Example 2

[0047] Take 90g of Coptis chinensis, add distilled water to cover the medicinal material for the first time, soak for 1 hour, and then boil over high heat. After boiling, filter with 3 layers of gauze to remove the residue and collect the liquid. Add distilled water to cover the medicinal material for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate to a concentration of 0.4 g / mL under reduced pressure using a rotary evaporator.

[0048] Comparative Example 3

[0049] Take 90g of costusroot, add distilled water to cover the herbs for the first time, soak for 1 hour, boil over high heat, filter with 3 layers of gauze to remove the residue, and collect the liquid. Add distilled water to cover the herbs for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate to a concentration of 0.4 g / mL under reduced pressure using a rotary evaporator.

[0050] Comparative Example 4

[0051] Take 90g of Angelica sinensis, add distilled water to cover the herbs for the first time, soak for 1 hour, boil over high heat, filter with 3 layers of gauze to remove the residue, and collect the liquid. Add distilled water to cover the herbs for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate to a concentration of 0.4 g / mL under reduced pressure using a rotary evaporator.

[0052] Comparative Example 5

[0053] Take 10g of Radix Sanguisorbae, 30g of Rhizoma Coptidis, 20g of Radix Aucklandiae, and 30g of Radix Angelicae Sinensis. Add distilled water to cover the medicinal materials for the first time and soak for 1 hour. Then boil over high heat. After boiling, filter with 3 layers of gauze to remove the residue and collect the liquid. Add distilled water to cover the medicinal materials for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate under reduced pressure to a concentration of 0.4 g / mL using a rotary evaporator.

[0054] Comparative Example 6

[0055] Take 30g of Sanguisorba officinalis, 10g of Coptis chinensis, 20g of Aucklandia lappa, and 30g of Angelica sinensis. Add distilled water to cover the medicinal materials for the first time and soak for 1 hour. Then boil over high heat. After boiling, filter with 3 layers of gauze to remove the residue and collect the liquid. Add distilled water to cover the medicinal materials for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate under reduced pressure with a rotary evaporator to a concentration of 0.4 g / mL.

[0056] Comparative Example 7

[0057] Take 20g of Radix Sanguisorbae, 20g of Rhizoma Coptidis, 30g of Radix Aucklandiae, and 20g of Radix Angelicae Sinensis. Add distilled water to cover the medicinal materials for the first time and soak for 1 hour. Then boil over high heat. After boiling, filter with 3 layers of gauze to remove the residue and collect the liquid. Add distilled water to cover the medicinal materials for the second time, boil over low heat for 30 minutes, filter with 3 layers of gauze after boiling, combine the two filtrates, and concentrate to a concentration of 0.4 g / mL under reduced pressure using a rotary evaporator.

[0058] Performance test Establishment of rat gastric mucosal injury model and drug efficacy test

[0059] After one week of adaptive feeding, male 4-week-old Kunming mice were randomly divided into 12 groups, with 10 mice in each group. The groups are as follows:

[0060] (1) Blank group: intragastric administration of normal saline;

[0061] (2) Model group: intragastric administration of normal saline;

[0062] (3) Example 1 group (hereinafter referred to as "Example"): The Chinese medicine composition prepared in Example 1 was administered intragastricly, with an intragastric dose of 0.2 mL / animal / day;

[0063] (4) Example 2 group: intragastric administration of the Chinese medicine composition prepared in Example 2, with an intragastric dose of 0.2 mL / animal / day;

[0064] (5) Example 3 group: intragastric administration of the Chinese medicine composition prepared in Example 3, with an intragastric dose of 0.2 mL / animal / day;

[0065] (6) Comparative Example 1 group: intragastric administration of the Chinese medicine prepared in Comparative Example 1, with an intragastric dose of 0.2 mL / animal / day;

[0066] (7) Comparative Example 2 group: intragastric administration of the Chinese medicine prepared in Comparative Example 2, with an intragastric dose of 0.2 mL / animal / day;

[0067] (8) Comparative Example 3 group: intragastric administration of the Chinese medicine prepared in Comparative Example 3, with an intragastric dose of 0.2 mL / animal / day;

[0068] (9) Comparative Example 4 group: intragastric administration of the Chinese medicine prepared in Comparative Example 4, with an intragastric dose of 0.2 mL / animal / day;

[0069] (10) Comparative Example 5 group: intragastric administration of the Chinese medicine prepared in Comparative Example 5, with an intragastric dose of 0.2 mL / animal / day;

[0070] (11) Comparative Example 6 group: intragastric administration of the Chinese medicine prepared in Comparative Example 6, with an intragastric dose of 0.2 mL / animal / day;

[0071] (12) Comparative Example 7 group: The Chinese medicine prepared in Comparative Example 7 was administered orally, with a dose of 0.2 mL / animal / day.

[0072] Each group was given the drug once a day for 7 consecutive days. The mice were fasted but not watered for 24 h before the last drug administration. 2 h after the last drug administration, mice in all groups except the blank group were gavaged with anhydrous ethanol (gavage dose was 0.1 mL / 10 g body weight) to induce gastric mucosal damage.

[0073] The mice were killed, the stomach was removed, cut open along the greater curvature of the stomach, the stomach contents were washed, and the gastric mucosa was unfolded for subsequent observation and testing.

[0074] 1. Gastric mucosal lesions in mice

[0075] Observe the gastric mucosal lesions of mice. Figure 1 As shown. Compared with the blank group mice, the gastric mucosal tissue of the model group mice showed mucosal congestion, bleeding, swelling, and obvious ulcer formation after acute alcohol treatment. Figure 1 It can be seen that the degree of damage to the gastric mucosal tissue of the mice in the Example group was significantly lower than that in the Model group, and mucosal congestion, bleeding and swelling were effectively alleviated. Therefore, the preparation in the Example has a significant preventive and therapeutic effect on gastric mucosal damage.

[0076] Meanwhile, the mice in groups 1 to 4 of the comparative example were first treated with a single Chinese medicine and then acutely treated with alcohol. Figure 1 It can be seen that compared with the model group, the congestion and bleeding of the gastric mucosa of the mice in Comparative Examples 1-4 were slightly alleviated, but the preventive and therapeutic effects on gastric mucosal damage were obviously not as good as those in the embodiment.

[0077] The mice in groups 5 to 7 of the comparative example were first administered with a drug compound preparation having a different drug ratio from that in the example, and then acutely treated with alcohol. Figure 1 It can be seen that compared with the model group, the gastric mucosal damage of the mice in the comparative example 5-7 groups was alleviated, and the congestion and bleeding were improved. However, compared with the preventive and therapeutic effect of the example preparations on gastric mucosal damage in mice, the effect of the comparative example 5-7 groups was still at a relatively low level.

[0078] In summary, it can be seen that the Sanguisorba officinalis, Coptis chinensis, Costus root and Angelica sinensis in the example preparations have a synergistic effect in preventing and treating gastric mucosal damage, and achieve excellent effects under specific dosage ratios, which can effectively alleviate gastric mucosal damage and prevent and treat the occurrence and development of related diseases such as gastric ulcers.

[0079] 2. Gastric mucosal injury index and gastric mucosal injury inhibition rate

[0080] The area of ​​gastric mucosal bleeding or ulcer and the corresponding total area of ​​gastric glands were measured by Image J software. The gastric mucosal injury index and gastric mucosal injury inhibition rate were used as test indicators, and the calculation formula was as follows:

[0081] Gastric mucosal injury index = gastric bleeding or ulcer area / corresponding gastric gland area × 100%

[0082] Gastric mucosal injury inhibition rate = 100% - injury index of drug-treated group / injury index of model group × 100%

[0083] The gastric mucosal injury index was calculated according to the formula. Figure 2 shown.

[0084] The drug damage inhibition rate was calculated according to the formula, and the results are shown in Table 1 and Figure 3 shown.

[0085] Table 1 Gastric mucosal injury index and injury inhibition rate in each group

[0086]

[0087] ## Indicates that there is a significant difference compared with the model group. ** It indicates that there is a significant difference compared with the example, P < 0.01.

[0088] Through Table 1 and Figure 2-3 It can be seen that compared with the model group (damage index 31.14%), after taking the composite preparation in the example, the damage index of the gastric mucosal tissue of the mice was significantly reduced (damage index 0.21%), and the damage inhibition rate of the preparation in the example was more than 95%, which was significantly better than the effect of the single preparation in comparative examples 1-4 (damage index 3.85%-13.52%), and also significantly better than the effect of the composite preparation in comparative examples 5-7 (damage index 7.37%-9.65%).

[0089] The above experimental results prove that when Sanguisorba officinalis, Coptis chinensis, Costusroot and Angelica sinensis are compounded in a specific ratio, they can synergize with each other in preventing and treating gastric mucosal damage, and exert a gastric mucosal protective effect that is significantly better than that of a single herb.

[0090] The embodiments described above are only some embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, other embodiments obtained by those skilled in the art without creative work shall all fall within the scope of protection of the present invention.

Claims

1. A preparation for preventing and treating gastric mucosal damage, characterized in that: The raw materials of the preparation are sanguisorba officinalis, coptis chinensis, costus root and angelica sinensis, and the weight proportions of sanguisorba officinalis, coptis chinensis, costus root and angelica sinensis are 12-27 parts of sanguisorba officinalis, 12-27 parts of coptis chinensis, 12-27 parts of costus root and 12-37 parts of angelica sinensis.

2. The preparation according to claim 1, characterized in that The weight proportions of the sanguisorba officinalis, coptis chinensis, costus root and angelica sinensis are 13-26 parts of sanguisorba officinalis, 13-26 parts of coptis chinensis, 13-26 parts of costus root and 24-36 parts of angelica sinensis.

3. The preparation according to claim 2, characterized in that The weight proportions of the sanguisorba officinalis, coptis chinensis, costus root and angelica sinensis are 15-25 parts of sanguisorba officinalis, 15-25 parts of coptis chinensis, 15-25 parts of costus root and 25-35 parts of angelica sinensis.

4. A method for preparing the preparation according to any one of claims 1 to 3, characterized in that: The preparation method comprises the steps of weighing raw materials, decocting, filtering and concentrating the filtrate.

5. The preparation method according to claim 4, characterized in that: The concentration is concentration under reduced pressure.

6. A composition, characterized in that The composition contains the preparation according to any one of claims 1 to 3.

7. Use of the preparation according to any one of claims 1 to 3 or the composition according to claim 6 in the preparation of a product for preventing and treating gastric mucosal injury and diseases related to gastric mucosal injury, wherein the product is a medicine, a feed additive or a feed.

8. The use according to claim 7, characterized in that: The application includes at least one of the following: (1) Application in the preparation of products for reducing gastric mucosal injury index; (2) Application in the preparation of products for improving the inhibition rate of gastric mucosal damage.

9. The use according to claim 7, characterized in that: The gastric mucosal injury-related disease includes at least one of gastric ulcer, acute gastritis and chronic gastritis.

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