Traditional Chinese medicine composition for protecting gastric mucosa and medicine for preventing and treating gastric ulcer

Abstract

The invention relates to a traditional Chinese medicine composition for protecting gastric mucosa and a medicine for preventing and treating gastric ulcer. The active ingredient of the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-20 parts of rhizoma bletillae, 5-15 parts of folium artemisiae argyi, 3-10 parts of liquorice, 3-10 parts of semen coicis and 3-5 parts of honey. The raw materials of the traditional Chinese medicine composition have synergistic interaction, can effectively increase gastric secretion, prevent gastric mucosal injury and promote gastric ulcer repair, and can be used for preparing medicines for preventing and / or treating gastric ulcer. The raw materials in the traditional Chinese medicine composition are all from natural traditional Chinese medicinal materials, and are cheap and safe. In addition, the traditional Chinese medicine composition is simple in preparation process, safe and low in cost.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for protecting gastric mucosa and a medicine for preventing and treating gastric ulcer. Background Art

[0002] In traditional Chinese medicine, gastric ulcer belongs to "epigastric pain". The causes of epigastric pain are mostly related to the combined effects of the six exogenous pathogens (wind, cold, heat, dampness, dryness, and fire), emotional imbalance, improper diet, and physical factors. Although the disease is in the stomach, it is often closely related to liver and spleen disharmony. The basic pathogenesis is spleen and stomach weakness, which leads to spleen and stomach reception and transportation disorders, qi stagnation in the middle jiao, lack of biochemical sources, and lack of nourishment to the stomach network, resulting in pain due to lack of nourishment. From the perspective of traditional Chinese medicine syndrome differentiation, spleen deficiency and stomach weakness are the main pathogenesis of gastric ulcer, and qi stagnation and blood stasis are the main pathological manifestations. Traditional Chinese medicine currently has no unified standard for the syndrome differentiation of gastric ulcer. Its treatment is mostly based on strengthening the spleen and stomach. According to the theory of viscera and qi and blood in traditional Chinese medicine, special prescriptions are added or subtracted according to the severity of the disease to achieve the purpose of improving or curing gastric ulcer. Summary of the invention

[0003] Based on this, the purpose of the present invention is to provide a Chinese medicine composition for protecting gastric mucosa, which can increase gastric juice secretion, prevent gastric mucosal damage, promote gastric ulcer repair, and can be used to prevent and treat gastric ulcer.

[0004] The first aspect of the present invention is to provide a traditional Chinese medicine composition for protecting gastric mucosa, wherein the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 5-20 parts of Bletilla striata, 5-15 parts of Artemisia argyi, 3-10 parts of Licorice, 3-10 parts of Coix seeds, and 3-5 parts of honey.

[0005] In some of the embodiments, the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 10-20 parts of Bletilla striata, 10-15 parts of Artemisia argyi, 3-5 parts of Licorice, 3-5 parts of Coix seeds, and 3-5 parts of honey.

[0006] In some of the embodiments, the active ingredients of the Chinese medicine composition are prepared from the following raw materials in parts by weight: 14-16 parts of Bletilla striata, 12-13 parts of Artemisia argyi, 4-5 parts of Licorice, 3.5-4.5 parts of Coix seeds, and 3.5-4.5 parts of honey.

[0007] In some of the embodiments, the active ingredients of the Chinese medicine composition are prepared from the following raw materials in parts by weight: 15 parts of Bletilla striata, 12.5 parts of Artemisia argyi, 4.5 parts of Licorice, 4 parts of Coix seeds, and 4 parts of honey.

[0008] The second aspect of the present invention is to provide use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for preventing and / or treating gastric ulcer.

[0009] The third aspect of the present invention is to provide a method for preparing the Chinese medicine composition as described above, comprising the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding an extraction reagent for extraction to obtain an extract, and adding the honey to obtain the extract.

[0010] In some embodiments, the extraction reagent is water or ethanol.

[0011] In some embodiments, the extraction is decoction extraction.

[0012] In some embodiments, the extraction includes the following steps: taking the white schizonepeta, wormwood leaf, liquorice and coix seed according to the amount, adding 5-15 times the total mass of water, boiling and extracting 1-3 times, each time for 1h-2h.

[0013] The fourth aspect of the present invention is to provide a drug for preventing and / or treating gastric ulcer, wherein the drug comprises an active ingredient and pharmaceutically acceptable excipients, wherein the active ingredient comprises the Chinese medicine composition as described above.

[0014] In some embodiments, each 1g of the drug contains not less than 1mg of Bletilla striata in the form of 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate; and / or

[0015] Containing not less than 0.01 mg of Artemisia argyi calculated as borneol; and / or,

[0016] Containing not less than 0.1 mg of liquorice in terms of liquiritin; and / or

[0017] Containing not less than 0.1 mg of coix seed calculated as triolein; and / or,

[0018] Honey should contain not less than 0.4 μg of 5-hydroxymethylfurfural

[0019] In some embodiments, the drug is in the form of oral liquid, granules, tablets, capsules, or pills.

[0020] The fifth aspect of the present invention is to provide a method for preparing the drug as described above.

[0021] In some embodiments, the dosage form of the drug is an oral liquid, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding an extraction reagent for extraction, taking the extract, precipitating, taking the supernatant, and concentrating under reduced pressure; adding ethanol and filtering; taking the filtrate, adding water, and filtering; adding the honey and preservative to the filtrate, mixing, and obtaining.

[0022] In some embodiments, the dosage form of the drug is a granule, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding an extraction reagent for extraction, taking the extract, precipitating, taking the supernatant, and concentrating under reduced pressure; adding the honey and mixing; adding ethanol and filtering; taking the filtrate, adding a disintegrant and a filler, granulating, and drying to obtain the product.

[0023] In some embodiments, the dosage form of the drug is a tablet, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding an extraction reagent for extraction, taking the extract, adding the honey, mixing, and concentrating under reduced pressure; adding a disintegrant and a filler, granulating, and tableting to obtain the product.

[0024] In some embodiments, the dosage form of the drug is a capsule, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding an extraction reagent for extraction, taking the extract, precipitating, taking the supernatant, and concentrating under reduced pressure; adding the honey and mixing; adding ethanol and filtering; taking the filtrate, adding a disintegrant and a filler, and granulating; adding a lubricant, mixing, and filling into capsules to obtain the product.

[0025] In some embodiments, the dosage form of the drug is pills, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding extraction reagent for extraction, taking the extract, precipitating, taking the supernatant, and concentrating under reduced pressure; adding the honey and water, making soft material into pills, and obtaining the product.

[0026] The present invention provides a Chinese medicine composition for protecting gastric mucosa, which is composed of appropriate weight portions of Bletilla striata, Artemisia argyi, Licorice, Coix seeds and honey. In the prescription, Bletilla striata and Artemisia argyi are both monarch drugs, Bletilla striata contains bibenzyl and phenanthrene derivatives, Bletilla striata polysaccharide, etc., which can astringe and stop bleeding, reduce swelling and promote tissue regeneration; Artemisia argyi can warm the meridians and stop bleeding, dispel cold and relieve pain; Licorice and Coix seeds are both ministerial drugs, Licorice can tonify the spleen and replenish qi, clear away heat and detoxify, relieve urgency and stop pain, and harmonize various drugs; Coix seeds can promote water and dampness, strengthen the spleen and stop diarrhea, remove numbness, discharge pus, detoxify and disperse knots; adjuvant honey can tonify the middle, moisten dryness, stop pain and detoxify. The five drugs are used together to play the effects of regulating qi, removing stagnation, removing blood stasis and relieving pain.

[0027] The raw materials of the Chinese medicine composition of the present invention are mutually synergistic and can effectively increase gastric juice secretion, prevent gastric mucosal damage and promote gastric ulcer repair, and can be used to prepare medicines and health products for preventing and / or treating gastric ulcers. The raw materials in the Chinese medicine composition are all derived from natural Chinese medicinal materials, among which Artemisia argyi, Licorice, Coix seeds and honey are both medicinal and edible varieties, and Bletilla striata is a commonly used Chinese medicinal material, which is cheap and safe. In addition, the preparation process of the Chinese medicine composition of the present invention is simple, safe and low in cost. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1These are photos of the stomach organs of rats in each group in Example 7. DETAILED DESCRIPTION

[0029] In order to facilitate the understanding of the present invention, the present invention will be described more fully below. The present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present invention more thorough and comprehensive.

[0030] The experimental methods in the following examples without specifying specific conditions are usually carried out under conventional conditions or conditions recommended by the manufacturers. The various commonly used chemical reagents used in the examples are all commercially available products.

[0031] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those commonly understood by those skilled in the art to which the present invention belongs. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used in the present invention includes any and all combinations of one or more of the related listed items.

[0032] In addition, as used in the present invention, the term "or" is an inclusive "or" symbol and is equivalent to the term "and / or", unless the context clearly dictates otherwise. The term "based on" is not exclusive and allows for being based on other factors not described, unless the context clearly dictates otherwise. In addition, throughout the specification, the meanings of "a", "an", and "the" include plural referents. The meaning of "in..." includes "in..." and "on...".

[0033] Some embodiments of the present invention relate to a traditional Chinese medicine composition for protecting gastric mucosa, wherein the active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 5-20 parts of Bletilla striata, 5-15 parts of Artemisia argyi, 3-10 parts of Licorice, 3-10 parts of Coix seeds, and 3-5 parts of honey.

[0034] In the formula, Bletilla striata and Artemisia argyi are both the main drugs. Bletilla striata contains bibenzyl and phenanthrene derivatives, Bletilla striata polysaccharides, etc., which can astringe and stop bleeding, reduce swelling and promote tissue regeneration; Artemisia argyi can warm the meridians and stop bleeding, dispel cold and relieve pain; Licorice and Coix seeds are both the assistant drugs. Licorice can nourish the spleen and replenish qi, clear away heat and detoxify, relieve urgency and stop pain, and harmonize the drugs; Coix seeds can promote diuresis and eliminate dampness, strengthen the spleen and stop diarrhea, remove numbness, discharge pus, and detoxify and disperse knots; the adjuvant honey can nourish the middle, moisten dryness, stop pain and detoxify. The five drugs are used together to achieve the effects of regulating qi, removing stagnation, removing blood stasis and relieving pain.

[0035] Bletilla striata: It is the dried tuber of Bletilla striata (Thunb.) Reichb.f. of the orchid family. It tastes bitter, sweet, astringent, and slightly cold. It enters the lung, liver, and stomach meridians.

[0036] Artemisia argyi Lévl. et Vant. is a plant of the Asteraceae family. It is pungent, bitter, warm, and slightly toxic. It enters the liver, spleen, and kidney meridians.

[0037] Licorice: It is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the Leguminosae family. It is sweet and neutral in nature. It enters the heart, lung, spleen and stomach meridians.

[0038] Coix seeds: the dried mature kernel of Coix lacryma-jobi L. var. mayuen (Roman.) Stapf. It is sweet, light and cool. It enters the spleen, stomach and lung meridians.

[0039] Honey: Honey produced by the Chinese honey bee, Apis cerana Fabricius, or the Italian honey bee, Apismellifera Linnaeus. It is sweet and neutral in nature. It enters the lung, spleen, and large intestine meridians.

[0040] Some embodiments of the present invention relate to a drug for preventing and / or treating gastric ulcer, wherein the drug comprises an active ingredient and pharmaceutically acceptable excipients, wherein the active ingredient comprises the Chinese medicine composition as described above.

[0041] The present invention is further described in detail below with reference to specific embodiments.

[0042] The quality control and detection method of the medicine of the present invention comprises the following steps:

[0043] (1) Quality control and detection method of Bletilla striata content (calculated as 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate).

[0044] The detection method is HPLC.

[0045] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; the mobile phase was acetonitrile-0.1% phosphoric acid solution (22:78); the detection wavelength was 223 nm. The theoretical plate number calculated by 1,4-di[4-(glucose oxygen) benzyl]-2-isobutyl malate should not be less than 2000.

[0046] Preparation of reference solution: Accurately weigh 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate reference substance, add dilute ethanol (50%) to make a 1 ml solution containing 0.15 mg of each.

[0047] Preparation of test solution: Preparation of test solution for liquid preparation: Take the liquid preparation and shake it evenly, filter it, and you are done. Preparation of test solution for solid preparation: Accurately weigh about 2g of fine powder of solid preparation (pass through No. 4 sieve), put it in a stoppered conical bottle, accurately add 100ml of dilute ethanol (70%), stopper it, weigh it, ultrasonicate it (power 250W, frequency 40kHz) for 30 minutes, let it cool, weigh it again, make up the lost weight with 70% ethanol, shake it evenly, filter it, and take the filtrate to get it.

[0048] Determination method: Accurately pipette 10 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0049] (2) Quality control and detection methods of mugwort leaf content (measured in borneol).

[0050] The detection method is gas chromatography.

[0051] Chromatographic conditions and system suitability test: stationary phase: 50% phenyl-methylpolysiloxane (column length 30m, inner diameter 0.25mm, film thickness 0.25μm); column temperature is programmed, initial temperature 45℃, first heated to 75℃ at a rate of 2℃ per minute, maintained for 5 minutes; then heated to 90℃ at a rate of 1℃ per minute, maintained for 6 minutes; then heated to 150℃ at a rate of 5℃ per minute; finally heated to 250℃ at a rate of 10℃ per minute, maintained for 5 minutes; injection port temperature 240℃; detector temperature 250℃. Flow rate 0.6ml per minute; split injection, split ratio 5:1. The theoretical plate number calculated based on borneol peak should not be less than 50,000.

[0052] Preparation of reference solution: Take an appropriate amount of borneol reference, accurately weigh it, and add ethyl acetate to make a mixed solution containing 0.1 mg of borneol per 1 ml.

[0053] Preparation of test solution: Preparation of test solution for liquid preparation: Take the liquid preparation and shake it evenly, filter it, and you are done. Preparation of test solution for solid preparation: Accurately weigh about 2g of fine powder of solid preparation (pass through No. 4 sieve), put it in a stoppered conical bottle, accurately add 100ml of dilute ethanol (70%), stopper it, weigh it, ultrasonicate it (power 250W, frequency 40kHz) for 30 minutes, let it cool, weigh it again, make up the lost weight with 70% ethanol, shake it evenly, filter it, and take the filtrate to get it.

[0054] Determination method: Accurately pipette 1 μl of reference solution and test solution respectively, inject into gas chromatograph, and determine.

[0055] (3) Quality control and detection methods of liquorice content (measured in glycyrrhizin).

[0056] The detection method is high performance liquid chromatography.

[0057] Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; the mobile phase is acetonitrile-0.05% phosphoric acid solution, the elution gradient is shown in Table 1 below; the detection wavelength is 237nm. The theoretical plate number calculated based on liquiritin should not be less than 5000.

[0058] Table 1 Elution gradient

[0059] time Mobile phase A (%) Mobile phase B (%) 0～8 19 81 8～35 19→50 81→50 35～36 50→100 50→0 36～40 100→19 0→81

[0060] Preparation of reference solution: Accurately weigh the liquiritin reference substance, add dilute ethanol (50%) to make a 1 ml solution containing 20 μg.

[0061] Preparation of test solution: Preparation of test solution for liquid preparation: Take the liquid preparation and shake it evenly, filter it, and you are done. Preparation of test solution for solid preparation: Accurately weigh about 2g of fine powder of solid preparation (pass through No. 4 sieve), put it in a stoppered conical bottle, accurately add 100ml of dilute ethanol (70%), stopper it, weigh it, ultrasonicate it (power 250W, frequency 40kHz) for 30 minutes, let it cool, weigh it again, make up the lost weight with 70% ethanol, shake it evenly, filter it, and take the filtrate to get it.

[0062] Determination method: Accurately pipette 10 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0063] (4) Quality control and detection methods of coix seed content (calculated as triolein).

[0064] The detection method is high performance liquid chromatography.

[0065] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; the mobile phase was acetonitrile-dichloromethane (65:35); evaporative light scattering detector was used for detection. The theoretical plate number calculated based on the trioleylglycerol peak should not be less than 5000.

[0066] Preparation of reference solution: Accurately weigh an appropriate amount of triolein reference substance and add mobile phase to make a 1 ml solution containing 0.14 mg.

[0067] Preparation of test solution: Preparation of test solution for liquid preparation: Take the liquid preparation and shake it evenly, filter it, and you are done. Preparation of test solution for solid preparation: Accurately weigh about 2g of fine powder of solid preparation (pass through No. 4 sieve), put it in a stoppered conical bottle, accurately add 100ml of dilute ethanol (70%), stopper it, weigh it, ultrasonicate it (power 250W, frequency 40kHz) for 30 minutes, let it cool, weigh it again, make up the lost weight with 70% ethanol, shake it evenly, filter it, and take the filtrate to get it.

[0068] Determination method: Accurately pipette 5μL and 10μL of the reference solution and 5-10μL of the test solution respectively, inject into liquid chromatograph, determine, and calculate with the external standard two-point method logarithmic equation to obtain the result.

[0069] (5) Quality control and detection methods of honey content (measured in 5-hydroxymethylfurfural).

[0070] The detection method is high performance liquid chromatography.

[0071] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; the mobile phase was acetonitrile-0.1% formic acid solution (5:95); the detection wavelength for 5-hydroxymethylfurfural was 284nm, and the detection wavelength for guanosine was 254nm. The theoretical plate number calculated based on the guanosine peak should be no less than 3000.

[0072] Preparation of reference solution: Accurately weigh an appropriate amount of guanosine reference substance, add 10% methanol to prepare 1 ml of solution containing 0.2 mg of guanosine; accurately weigh an appropriate amount of 5-hydroxymethylfurfural reference substance, add 10% methanol to prepare 1 ml of 4 μg solution for positioning.

[0073] Preparation of test solution: Preparation of test solution for liquid preparation: Take the liquid preparation and shake it evenly, filter it, and you are done. Preparation of test solution for solid preparation: Accurately weigh about 2g of fine powder of solid preparation (pass through No. 4 sieve), put it in a stoppered conical bottle, accurately add 100ml of dilute ethanol (70%), stopper it, weigh it, ultrasonicate it (power 250W, frequency 40kHz) for 30 minutes, let it cool, weigh it again, make up the lost weight with 70% ethanol, shake it evenly, filter it, and take the filtrate to get it.

[0074] Determination method: Accurately pipette 10 μL of the test solution, inject into the liquid chromatograph, and determine; separately take 10 μL of guanosine reference solution and 5-hydroxymethylfurfural reference solution, and determine to determine the chromatographic peaks of 5-hydroxymethylfurfural and guanosine in the test sample chromatogram; calculate the content with the guanosine reference solution and correct it by multiplying it by the correction factor 0.340.

[0075] The sources of the reference substances of the present invention are as follows:

[0076] 1,4-Di[4-(glucose oxygen)benzyl]-2-isobutylmalate reference substance (China Food and Drug Inspection Institute, 112061-202102);

[0077] Borneol reference substance (China Food and Drug Inspection Institute, 110881-201709);

[0078] Liquorice glycoside reference substance (China Food and Drug Inspection Institute, 111610-202209);

[0079] Glyceryl trioleate reference substance (China Food and Drug Inspection Institute, 111692-202208);

[0080] Hydroxymethylfurfural reference substance (China Food and Drug Inspection Institute, 111626-202316).

[0081] Example 1 Solution

[0082] Weigh 15g of Bletilla striata, 12.5g of Artemisia argyi, 4.5g of Licorice tablets, and 4g of Coix seeds according to the weight ratio, add water (10 times the total weight of the original medicinal materials), and boil for 3 times, 2 hours for the first time, 1 hour for the second and third times respectively, and let the combined decoctions stand for 12 hours to allow them to precipitate. Take the supernatant and concentrate it to an appropriate amount under reduced pressure, add ethanol to make the alcohol content reach 75%, refrigerate for 10 hours, filter, and recover the filtrate until there is no alcohol taste, add an appropriate amount of water and stir, refrigerate for 12 hours, filter, add 4g of honey and 0.02g of potassium sorbate to the filtrate to dissolve it, add water to adjust to 100mL, stir well, filter, and obtain a solution.

[0083] The solution prepared in this example was subjected to quality control and testing, and the results showed that per 1 g of the solution, the content of Bletilla striata was calculated as 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate was 1.03 mg; the content of Artemisia argyi was calculated as eucalyptus borneol was 0.01 mg; the content of Licorice was calculated as liquiritin was 0.11 mg; the content of Coix lachryma-jobi was calculated as triolein was 0.10 mg; and the content of honey was calculated as 5-hydroxymethylfurfural was 0.40 μg.

[0084] Example 2 Granules

[0085] According to the weight ratio, weigh 15g of Bletilla striata, 12.5g of Artemisia argyi, 4.5g of Licorice tablets, and 4g of Coix seeds, add water (10 times the total weight of the original medicinal materials) and boil for 3 times, 2 hours for the first time, 1 hour for the second and third times respectively, and let the combined decoctions stand for 12 hours to allow them to precipitate. Take the supernatant and concentrate it to an appropriate amount under reduced pressure, add 4g of honey, stir evenly, add ethanol to make the alcohol content reach 75%, refrigerate for 10 hours, filter, recover the filtrate until there is no alcohol taste, add disintegrant and filler, granulate with 70% ethanol, dry at 55°C, sieve, and package to obtain granules.

[0086] The granules prepared in this example were subjected to quality control and testing, and the results showed that per 1 g of granules, the amount of Bletilla striata calculated as 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate was 1.03 mg; the amount of Artemisia argyi calculated as eucalyptus borneol was 0.01 mg; the amount of Licorice calculated as liquiritin was 0.10 mg; the amount of Coix lachryma-jobi calculated as triolein was 0.10 mg; and the amount of honey calculated as 5-hydroxymethylfurfural was 0.43 μg.

[0087] Example 3 Tablets

[0088] Weigh 15g of Bletilla striata, 12.5g of Artemisia argyi, 4.5g of licorice tablets, and 4g of Coix seeds according to the weight ratio, add water (10 times the total weight of the original medicinal materials), and boil for 3 times, 2 hours for the first time, and 1 hour for the second and third times respectively. Combine the decoctions, add 4g of honey and stir evenly, concentrate under reduced pressure to an appropriate amount, then add disintegrants and fillers, granulate with 70% ethanol, dry at 55°C, and press into tablets to obtain tablets.

[0089] The tablets prepared in this example were subjected to quality control and testing, and the results showed that per 1 gram of the tablet, the content of Bletilla striata was calculated as 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate was 1.01 mg; the content of Artemisia argyi was calculated as eucalyptus borneol was 0.01 mg; the content of Licorice was calculated as liquiritin was 0.11 mg; the content of Coix lachryma-jobi was calculated as triolein was 0.10 mg; and the content of honey was calculated as 5-hydroxymethylfurfural was 0.43 μg.

[0090] Example 4 Capsules

[0091] According to the weight ratio, weigh 15g of Bletilla striata, 12.5g of Artemisia argyi, 4.5g of Licorice tablets, and 4g of Coix seeds, add water (10 times the total weight of the original medicinal materials) and boil for 3 times, 2 hours for the first time, 1 hour for the second and third times respectively, and let the combined decoctions stand for 12 hours to allow them to precipitate. Take the supernatant and concentrate it to an appropriate amount under reduced pressure, add 4g of honey, stir evenly, add ethanol to make the alcohol content reach 75%, refrigerate for 10 hours, filter, recover the filtrate until there is no alcohol taste, add disintegrant and filler, granulate with 70% ethanol, dry at 55°C, add 0.2% lubricant, mix evenly, and fill capsules to obtain capsules.

[0092] The capsules prepared in this example were subjected to quality control and testing, and the results showed that per 1 gram of the capsules, the amount of Bletilla striata calculated as 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate was 1.01 mg; the amount of Artemisia argyi calculated as borneol was 0.01 mg; the amount of Licorice calculated as liquiritin was 0.11 mg; the amount of Coix lachryma-jobi calculated as triolein was 0.10 mg; and the amount of honey calculated as 5-hydroxymethylfurfural was 0.40 μg.

[0093] Example 5 Pills

[0094] Weigh 15g of Bletilla striata, 12.5g of Artemisia argyi, 4.5g of Licorice tablets and 4g of Coix seeds according to the weight ratio, add water (10 times the total weight of the original medicinal materials) and boil for 3 times, 2 hours for the first time, 1 hour for the second and third times respectively, combine the decoctions, concentrate to an appropriate amount under reduced pressure, add 4g of honey and an appropriate amount of water, and make pills with the soft material.

[0095] The pills prepared in this example were subjected to quality control and testing, and the results showed that per 1 gram of the pills, the content of Bletilla striata was calculated as 1,4-di[4-(glucose oxygen)benzyl]-2-isobutylmalate was 1.01 mg; the content of Artemisia argyi was calculated as borneol eucalyptus was 0.01 mg; the content of Licorice was calculated as liquiritin was 0.10 mg; the content of Coix lachryma-jobi was calculated as triolein was 0.10 mg; and the content of honey was calculated as 5-hydroxymethylfurfural was 0.43 μg.

[0096] Example 6 Drug Efficacy Study

[0097] The solution used in the experiment was prepared by the following method: 15 g of Bletilla striata, 12.5 g of Artemisia argyi, 4.5 g of Licorice tablets, and 4 g of Coix seeds were weighed in weight proportion, and water (10 times the total weight of the original medicinal materials) was added and decocted for 3 times, 2 hours for the first time, 1 hour for the second and third times respectively, the combined decoction was allowed to stand for 12 hours to allow it to precipitate, the supernatant was concentrated under reduced pressure to an appropriate amount, ethanol was added to make the alcohol content reach 75%, refrigerated for 10 hours, filtered, the filtrate was recovered until there was no alcohol taste, an appropriate amount of water was added and stirred, refrigerated for 12 hours, filtered, 4 g of honey and 0.02 g of potassium sorbate were added to the filtrate to dissolve it, water was added to adjust the volume to 100 mL, stirred well, filtered, and a solution was obtained.

[0098] Control composition 1: 15g of Bletilla striata, 12.5g of Artemisia argyi, and 4g of honey. The control composition 1 is prepared into solution 1 according to the following method: 15g of Bletilla striata and 12.5g of Artemisia argyi are weighed in weight proportion, and water (10 times the total weight of the original medicinal materials) is added and decocted for 3 times, 2 hours for the first time, 1 hour for the second and third times respectively, the combined decoction is placed for 12 hours to precipitate, the supernatant is concentrated to an appropriate amount under reduced pressure, ethanol is added to make the alcohol content reach 75%, refrigerated for 10 hours, filtered, the filtrate is recovered until there is no alcohol taste, an appropriate amount of water is added and stirred, refrigerated for 12 hours, filtered, 4g of honey and 0.02g of potassium sorbate are added to the filtrate to dissolve it, water is added to adjust the volume to 100mL, stirred evenly, filtered, and solution 1 is obtained.

[0099] Control composition 2: 15g of Bletilla striata, 12.5g of Artemisia argyi, 4g of Chinese yam, 4g of dried tangerine peel, and 4g of honey. The control composition 2 is prepared into solution 2 according to the following method: 15g of Bletilla striata, 12.5g of Artemisia argyi, 4g of Chinese yam, and 4g of dried tangerine peel are weighed in weight proportions and boiled 3 times with water (10 times the total weight of the original medicinal materials), 2 hours for the first time, 1 hour for the second and third times respectively, the combined decoction is placed for 12 hours to precipitate, the supernatant is concentrated to an appropriate amount under reduced pressure, ethanol is added to make the alcohol content reach 75%, refrigerated for 10 hours, filtered, the filtrate is recovered until there is no alcohol taste, an appropriate amount of water is added and stirred, refrigerated for 12 hours, filtered, 4g of honey and 0.02g of potassium sorbate are added to the filtrate to dissolve it, water is added to adjust the volume to 100mL, stirred evenly, filtered, and solution 2 is obtained.

[0100] Test product:

[0101] The solution of the present invention has a low concentration, a content of 0.2 g crude drug / mL, a batch number of 240601, and a validity period of September 2024, and is provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd.

[0102] The concentration of the solution of the present invention, content: 0.4g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd.

[0103] The solution of the present invention has a high concentration, a content of 0.8 g crude drug / mL, a batch number of 240601, and a validity period of until September 2024, and is provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd.

[0104] Solution 1, content: 0.8 g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd.

[0105] Solution 2, content: 0.8 g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd.

[0106] Bletilla striata extract, content: 0.8g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., the preparation method is as follows: take 15g of Bletilla striata, add water (10 times the total mass of the original medicinal material) and boil for 3 times, the first time for 2 hours, the second and third times for 1 hour each, the combined decoction is placed for 12 hours to precipitate, the supernatant is concentrated to an appropriate amount under reduced pressure, ethanol is added to make the alcohol content reach 75%, refrigerate for 10 hours, filter, recover the filtrate until there is no alcohol taste, add an appropriate amount of water and stir, refrigerate for 12 hours, filter, add 0.02g of potassium sorbate to the filtrate to dissolve it, add water to adjust to 100mL, stir well, filter, and obtain.

[0107] Artemisia argyi extract, content: 0.8g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., the preparation method is as follows: take 12.5g of artemisia argyi, add water (10 times the total mass of the original medicinal material) and boil it 3 times, the first time for 2 hours, the second and third times for 1 hour each, the combined decoction is placed for 12 hours to allow it to precipitate, the supernatant is concentrated under reduced pressure to an appropriate amount, ethanol is added to make the alcohol content reach 75%, refrigerated for 10 hours, filtered, the filtrate is recovered until there is no alcohol taste, an appropriate amount of water is added and stirred, refrigerated for 12 hours, filtered, 0.02g of potassium sorbate is added to the filtrate to dissolve it, water is added to adjust to 100mL, stirred well, filtered, and the product is obtained.

[0108] Licorice extract, content: 0.8g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., the preparation method is as follows: take 4.5g of licorice tablets, add water (10 times the total mass of the original medicinal material) and boil three times, the first time for 2 hours, the second and third times for 1 hour each, the combined decoction is placed for 12 hours to precipitate, the supernatant is concentrated to an appropriate amount under reduced pressure, ethanol is added to make the alcohol content reach 75%, refrigerate for 10 hours, filter, recover the filtrate until there is no alcohol taste, add an appropriate amount of water and stir, refrigerate for 12 hours, filter, add 0.02g of potassium sorbate to the filtrate to dissolve it, add water to adjust to 100mL, stir well, filter, and obtain.

[0109] Coix seed extract, content: 0.8g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., the preparation method is as follows: take 4g of coix seed, add water (10 times the total mass of the original medicinal material) and boil it 3 times, the first time for 2 hours, the second and third times for 1 hour each, the combined decoction is placed for 12 hours to precipitate, the supernatant is concentrated to an appropriate amount under reduced pressure, ethanol is added to make the alcohol content reach 75%, refrigerate for 10 hours, filter, recover the filtrate until there is no alcohol taste, add an appropriate amount of water and stir, refrigerate for 12 hours, filter, add 0.02g of potassium sorbate to the filtrate to dissolve it, add water to adjust to 100mL, stir well, filter, and obtain.

[0110] Honey aqueous solution, content: 0.8g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., the preparation method is as follows: take 4g of honey and dissolve it in water.

[0111] Weileshu oral liquid is a light yellow to light brown viscous liquid, taken orally, 10mL / time, twice a day. Indications: invigorating the spleen and stomach, relieving pain. Used for stomachache due to spleen deficiency, epigastric pain (gastritis, chronic atrophic gastritis, gastric ulcer and duodenal ulcer). Provided by Jiangsu Shenhua Pharmaceutical Co., Ltd.

[0112] Normal saline solution.

[0113] The above-mentioned solution was used for drug efficacy research, wherein different dosage groups of the solution of the present invention were respectively recorded as a low-dose group of the composition of the present invention, a medium-dose group of the composition of the present invention, and a high-dose group of the composition of the present invention; the solution 1 administration group was recorded as a control composition group 1; and the solution 2 administration group was recorded as a control composition group 2.

[0114] The experimental animals are shown in Table 2:

[0115] Table 2 Experimental animals

[0116]

[0117] Main experimental instruments: mainly include scalpels, surgical scissors, etc.

[0118] Test sample preparation: as described above.

[0119] Grouping and dosing:

[0120] Grouping: 36 SPF SD rats that passed the quarantine were selected and randomly divided into 12 groups, with 3 rats in each group.

[0121] Dosage: The dosing regimen for animal experiments is shown in Table 3:

[0122] Table 3 Dosage regimen for animal experiments

[0123]

[0124]

[0125] Control composition 1, control composition 2, Bletilla striata extract, Artemisia argyi extract, Licorice extract, Coix seed extract, honey aqueous solution are used for comparison in the present invention to verify the synergistic effect of the composition of the present invention, so a high dose of the composition of the present invention is used. The dosage setting is based on the body surface area normalization method to convert the clinical intended dose into a rat dosage by equivalent conversion.

[0126] Observation indicators

[0127] Observation of physical signs and body weight monitoring of rats

[0128] The rats' physical signs were observed after administration every day. The observation indicators included: animal appearance, behavioral activities, secretions, excretions, diet, death (number of deaths, time of death, pre-death reactions), etc.

[0129] Gastric juice secretion and acidity in rats

[0130] Before the last administration, the animals were fasted but not watered for 24 hours. After anesthesia, the abdomen was shaved and disinfected, an incision was made along the midline below the xiphoid process, the stomach was gently removed, the gastric pylorus was ligated, and the incision was sutured to complete the first operation. The last administration was completed after the operation, and the animals were fasted but not watered. After 4 hours of anesthesia, the first surgical incision was opened, the gastric cardia was ligated, and the stomach was removed.

[0131] The stomach was cut open along the greater curvature, gastric juice was collected, centrifuged (4°C, 2600g for 10 min), the supernatant was collected, and the volume of gastric juice was measured. Then 1 mL of gastric juice was taken to measure the total acidity of gastric acid using the acid-base titration method, and the gastric acid secretion rate was calculated using the following formula:

[0132] Total gastric acidity = (NaOH concentration * volume) / amount of gastric juice taken for titration;

[0133] Gastric acid secretion rate = (total acidity * total gastric juice volume) / collection time.

[0134] Animal treatment

[0135] Gross dissection: At the end of the experiment, the experimental animals shall be dissected grossly in accordance with relevant regulations, and the surface color, shape, size and texture of major organs such as the heart, liver, spleen, lungs, kidneys, gastrointestinal tract, brain, and drug administration site shall be observed with the naked eye to see if there are obvious toxic pathological changes, which shall be recorded on the animal disposal record sheet. If there are obvious lesions in the organs visible to the naked eye during the gross dissection, a comprehensive analysis shall be conducted based on the degree of the lesion to determine whether a histopathological examination shall be performed.

[0136] If an animal is found dead or dying during the experiment, a gross dissection should be performed on the animal in a timely manner in accordance with relevant regulations, and the surface color, shape, size, and texture of major organs such as the heart, liver, spleen, lungs, kidneys, gastrointestinal tract, brain, and administration site should be observed for obvious toxic and pathological changes, and the information should be recorded in the animal disposal record sheet.

[0137] result

[0138] 1. Clinical Observation in Rats

[0139] No obvious abnormalities in activity were found.

[0140] 2. Effects on gastric juice secretion in rats

[0141] The gastric juice volume, total acidity of gastric juice and gastric acid secretion rate of rats in each group are shown in Table 4:

[0142] Table 4 Effects on gastric juice secretion in rats ( N=3)

[0143]

[0144]

[0145] Compared with the blank control group, *p<0.05; **p<0.01.

[0146] The results show that the Chinese medicine composition of the present invention can significantly promote gastric juice secretion and increase the amount of gastric juice; and significantly reduce gastric acid acidity and gastric acid secretion rate, indicating that it has a significant protective effect on gastric mucosa. And this effect is stronger than the extracts of each component at the same dose, showing that there is a synergistic effect between the components. Moreover, under the same dosage, the gastric mucosal protective effect of the composition of the present invention (high dose group) is significantly better than that of the control composition 1 and the control composition 2. The raw materials for preparing the active ingredients of the composition of the present invention are composed of appropriate amounts of white schizonepeta, wormwood, licorice, coix seed and honey. In the prescription, white schizonepeta and wormwood are the main medicines, licorice and coix seed are the ministerial medicines, and honey is the adjuvant. The five medicines are used together to play the effects of regulating qi and stagnation, removing blood stasis and relieving pain. The control group composition 1 does not contain licorice and coix seed, and the raw materials cannot promote each other well; in the control composition 2, yam and tangerine peel are used instead of licorice and coix seed, and its protective effect on gastric mucosa is significantly reduced, indicating that the raw materials of the composition of the present invention can better cooperate.

[0147] Example 7 Pharmacodynamics on rats with ethanol-induced gastric ulcer

[0148] This example uses the same solution of the present invention, solution 1, solution 2 and various raw material extracts as in Example 6 to conduct experiments.

[0149] Test product:

[0150] The solution of the present invention has a low concentration, a content of 0.2 g crude drug / mL, a batch number of 240601, and a validity period of September 2024. It is provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., and the preparation method is the same as that of Example 6.

[0151] The concentration in the solution of the present invention, content: 0.4g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., and the preparation method is the same as Example 6.

[0152] The solution of the present invention has a high concentration, a content of 0.8 g crude drug / mL, a batch number of 240601, and a validity period of September 2024. It is provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., and the preparation method is the same as that of Example 6.

[0153] Solution 1, content: 0.8 g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., and the preparation method is the same as Example 6.

[0154] Solution 2, content: 0.8 g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., and the preparation method is the same as Example 6.

[0155] Bletilla striata extract, content: 0.8 g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., and the preparation method is the same as Example 6.

[0156] Artemisia argyi extract, content: 0.8 g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., and the preparation method is the same as Example 6.

[0157] Licorice extract, content: 0.8 g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., and the preparation method is the same as Example 6.

[0158] Coix seed extract, content: 0.8 g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., preparation method is the same as Example 6.

[0159] Honey aqueous solution, content: 0.8 g crude drug / mL, batch number: 240601, valid until September 2024, provided by Hunan Hengxing Pharmaceutical Technology Co., Ltd., preparation method is the same as Example 6.

[0160] Weileshu oral liquid is a light yellow to light brown viscous liquid, taken orally, 10mL / time, twice a day. Indications: invigorating the spleen and stomach, relieving pain. Used for stomachache due to spleen deficiency, epigastric pain (gastritis, chronic atrophic gastritis, gastric ulcer and duodenal ulcer). Provided by Jiangsu Shenhua Pharmaceutical Co., Ltd.

[0161] Normal saline solution.

[0162] The above-mentioned solution was used for drug efficacy research, wherein different dosage groups of the solution of the present invention were respectively recorded as a low-dose group of the composition of the present invention, a medium-dose group of the composition of the present invention, and a high-dose group of the composition of the present invention; the solution 1 administration group was recorded as a control composition group 1; and the solution 2 administration group was recorded as a control composition group 2.

[0163] The experimental animals are shown in Table 5:

[0164] Table 5 Experimental animals

[0165]

[0166] Main experimental instruments: mainly include scalpels, surgical scissors, etc.

[0167] Test sample preparation: as described above.

[0168] Thirty-nine SPF SD rats that passed the quarantine were selected and randomly divided into 13 groups, with 3 rats in each group. Twelve of the groups were gastric ulcer model groups, which were given 80% ethanol after the administration. The remaining group was a normal rat group, which was only given the same volume of saline.

[0169] Dosage: The dosing regimen for animal experiments is shown in Table 6:

[0170] Table 6 Dosage regimen for animal experiments

[0171]

[0172]

[0173] The control composition 1, the control composition 2, the extract of Bletilla striata, the extract of Artemisia argyi, the extract of Licorice, the extract of Coix lachryma-jobi, and the aqueous honey solution are used for comparison in the present invention to verify the synergistic effect of the composition of the present invention, so the high dose of the composition of the present invention is used. The Wei Le Shu oral solution adopts the clinical dosage and is equivalently converted into the dosage for rat administration.

[0174] Observation indicators

[0175] Observation of physical signs and body weight monitoring of rats

[0176] The rats' physical signs were observed after administration every day. The observation indicators included: animal appearance, behavioral activities, secretions, excretions, diet, death (number of deaths, time of death, pre-death reactions), etc.

[0177] Gastric ulcer index in rats

[0178] After the last administration, 1 mL / rat of AL group was given 80% ethanol, and 1 mL / rat of M group was given normal saline. 30 minutes after modeling, the whole stomach was removed, cut open and rinsed with normal saline, and the length of gastric mucosal lesions (in cm) was measured with a precision caliper, and the sum of the lengths of gastric mucosal lesions was used as the ulcer index.

[0179] Animal treatment

[0180] Gross dissection: At the end of the experiment, the experimental animals shall be dissected grossly in accordance with relevant regulations, and the surface color, shape, size and texture of major organs such as the heart, liver, spleen, lungs, kidneys, gastrointestinal tract, brain, and drug administration site shall be observed with the naked eye to see if there are obvious toxic pathological changes, which shall be recorded on the animal disposal record sheet. If there are obvious lesions in the organs visible to the naked eye during the gross dissection, a comprehensive analysis shall be conducted based on the degree of the lesion to determine whether a histopathological examination shall be performed.

[0181] If an animal is found dead or dying during the experiment, a gross dissection should be performed on the animal in a timely manner in accordance with relevant regulations, and the surface color, shape, size, and texture of major organs such as the heart, liver, spleen, lungs, kidneys, gastrointestinal tract, brain, and administration site should be observed for obvious toxic and pathological changes, and the information should be recorded in the animal disposal record sheet.

[0182] result

[0183] 1. Clinical Observation in Rats

[0184] No obvious abnormalities in activity were found.

[0185] 2. Effect on ulcer index of rats

[0186] The ulcer index results of rats in each group are shown in Table 7:

[0187] Table 7 Effects on ulcer index of ethanol-injured rats ( N=3)

[0188]

[0189]

[0190] Compared with the blank model group, *p<0.05; compared with the high-dose group of the Chinese medicine composition of the present invention, +p<0.05.

[0191] 3. Gross anatomy

[0192] No obvious pathological changes were observed in the organs (except the gastrointestinal tract) by naked eye observation.

[0193] Figure 1 Table 7 and Figure 1 The results showed that compared with the saline (model rat) group, the low, medium and high dose groups of the Chinese medicine composition of the present invention can effectively reduce the rat ulcer index. Moreover, the effect of the Chinese medicine composition of the present invention on reducing the rat ulcer index is significantly better than that of Wei Le Shu oral liquid, each raw material extract group, control composition 1 and control composition 2. The results show that the composition of the present invention can significantly reduce the ethanol-induced gastric mucosal injury index and has a significant protective effect on ethanol-induced gastric mucosal injury, and the effect is stronger than that of the extracts of each component, control composition 1 and control composition 2 at the same dose, further indicating that the raw materials of the Chinese medicine composition of the present invention show better synergistic effects.

[0194] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A Chinese medicine composition for protecting gastric mucosa, characterized in that: The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 5-20 parts of bletilla striata, 5-15 parts of wormwood leaves, 3-10 parts of liquorice, 3-10 parts of coix seeds, and 3-5 parts of honey.

2. The Chinese medicine composition according to claim 1, characterized in that The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 10-20 parts of bletilla striata, 10-15 parts of wormwood leaves, 3-5 parts of liquorice, 3-5 parts of coix seeds, and 3-5 parts of honey.

3. The Chinese medicine composition according to claim 2, characterized in that: The active ingredients of the traditional Chinese medicine composition are prepared from the following raw materials in parts by weight: 14-16 parts of bletilla striata, 12-13 parts of wormwood leaves, 4-5 parts of liquorice, 3.5-4.5 parts of coix seeds, and 3.5-4.5 parts of honey.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: Take the bletilla striata, wormwood leaf, liquorice and coix seed according to the amount, add the extraction reagent for extraction, obtain the extract, add the honey to obtain the extract.

5. The preparation method according to claim 4, characterized in that: The extraction reagent is water or ethanol; and / or the extraction is decoction extraction; Preferably, the extraction comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding 5-15 times of water in amount of the total mass of the raw materials, decocting and extracting 1-3 times, each time for 1h-2h.

6. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for preventing and / or treating gastric ulcer.

7. A drug for preventing and / or treating gastric ulcer, characterized in that: The medicine comprises an active ingredient and pharmaceutically acceptable excipients, and the active ingredient includes the traditional Chinese medicine composition according to any one of claims 1 to 3.

8. The drug according to claim 7, characterized in that Each 1g of the drug contains not less than 1mg of Bletilla striata in the form of 1,4-di-[4-(glucose oxygen) benzyl]-2-isobutyl malate; and / or Containing not less than 0.01 mg of Artemisia argyi calculated as borneol; and / or, Containing not less than 0.1 mg of liquorice calculated as liquiritin; and / or, Containing not less than 0.1 mg of coix seed calculated as triolein; and / or, The content of honey in terms of 5-hydroxymethylfurfural shall not be less than 0.4 μg.

9. The drug according to claim 7, characterized in that The dosage form of the medicine is oral liquid, granules, tablets, capsules and pills.

10. The method for preparing the drug according to claim 7, characterized in that: The dosage form of the drug is an oral liquid, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding an extraction reagent for extraction, taking the extract, precipitating, taking the supernatant, and concentrating under reduced pressure; adding ethanol and filtering; taking the filtrate, adding water and filtering; adding the honey and preservative to the filtrate, mixing, and obtaining; Or, the dosage form of the drug is a granule, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding an extraction reagent for extraction, taking the extract, precipitating, taking the supernatant, and concentrating under reduced pressure; adding the honey, mixing; adding ethanol, filtering; taking the filtrate, adding a disintegrant and a filler, granulating, and drying to obtain; Or, the dosage form of the drug is a tablet, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding an extraction reagent for extraction, taking the extract, adding the honey, mixing, and concentrating under reduced pressure; adding a disintegrant and a filler, granulating, and tableting to obtain; Or, the dosage form of the drug is a capsule, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding an extraction reagent for extraction, taking the extract, precipitating, taking the supernatant, and concentrating under reduced pressure; adding the honey, mixing; adding ethanol, filtering; taking the filtrate, adding a disintegrant and a filler, granulating; adding a lubricant, mixing, and filling the capsule to obtain: Or, the dosage form of the drug is pills, and the preparation method comprises the following steps: taking the Bletilla striata, Artemisia argyi, Licorice and Coix seeds according to the amount, adding extraction reagent for extraction, taking the extract, precipitating, taking the supernatant, and concentrating under reduced pressure; adding the honey and water, making soft material into pills, and obtaining the product.

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