CN117959372A - Therapeutic pharmaceutical composition for peptic gastric ulcer and preparation method thereof - Google Patents
Therapeutic pharmaceutical composition for peptic gastric ulcer and preparation method thereof Download PDFInfo
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- CN117959372A CN117959372A CN202410381299.3A CN202410381299A CN117959372A CN 117959372 A CN117959372 A CN 117959372A CN 202410381299 A CN202410381299 A CN 202410381299A CN 117959372 A CN117959372 A CN 117959372A
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- white jade
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- pepsin
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 54
- 238000002360 preparation method Methods 0.000 title claims abstract description 53
- 208000007107 Stomach Ulcer Diseases 0.000 title claims abstract description 34
- 201000005917 gastric ulcer Diseases 0.000 title claims abstract description 33
- 230000001175 peptic effect Effects 0.000 title claims abstract description 22
- 230000001225 therapeutic effect Effects 0.000 title claims abstract description 13
- 239000000284 extract Substances 0.000 claims abstract description 195
- 241000237858 Gastropoda Species 0.000 claims abstract description 91
- 240000003826 Eichhornia crassipes Species 0.000 claims abstract description 81
- 239000010977 jade Substances 0.000 claims abstract description 75
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims abstract description 54
- 102000057297 Pepsin A Human genes 0.000 claims abstract description 49
- 108090000284 Pepsin A Proteins 0.000 claims abstract description 49
- 229940111202 pepsin Drugs 0.000 claims abstract description 45
- 210000003097 mucus Anatomy 0.000 claims abstract description 32
- 240000001548 Camellia japonica Species 0.000 claims abstract description 27
- 235000018597 common camellia Nutrition 0.000 claims abstract description 27
- 239000000395 magnesium oxide Substances 0.000 claims abstract description 27
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims abstract description 27
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims abstract description 27
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims abstract description 27
- 235000017557 sodium bicarbonate Nutrition 0.000 claims abstract description 27
- 235000015112 vegetable and seed oil Nutrition 0.000 claims abstract description 27
- 241000237636 Pheretima Species 0.000 claims abstract description 17
- 239000003814 drug Substances 0.000 claims abstract description 16
- 239000007858 starting material Substances 0.000 claims abstract description 15
- 102000004142 Trypsin Human genes 0.000 claims abstract description 13
- 108090000631 Trypsin Proteins 0.000 claims abstract description 13
- 239000012588 trypsin Substances 0.000 claims abstract description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 91
- 108090000790 Enzymes Proteins 0.000 claims description 50
- 102000004190 Enzymes Human genes 0.000 claims description 50
- 229940088598 enzyme Drugs 0.000 claims description 50
- 238000010438 heat treatment Methods 0.000 claims description 50
- 238000002156 mixing Methods 0.000 claims description 44
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 42
- 239000002775 capsule Substances 0.000 claims description 33
- 239000000203 mixture Substances 0.000 claims description 28
- 239000002002 slurry Substances 0.000 claims description 28
- 238000001816 cooling Methods 0.000 claims description 27
- 230000000415 inactivating effect Effects 0.000 claims description 27
- 238000004108 freeze drying Methods 0.000 claims description 23
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 21
- 238000001914 filtration Methods 0.000 claims description 15
- 239000007788 liquid Substances 0.000 claims description 14
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- 238000000108 ultra-filtration Methods 0.000 claims description 14
- 238000004140 cleaning Methods 0.000 claims description 11
- 239000004382 Amylase Substances 0.000 claims description 10
- 108010065511 Amylases Proteins 0.000 claims description 10
- 102000013142 Amylases Human genes 0.000 claims description 10
- 108010004032 Bromelains Proteins 0.000 claims description 10
- 239000004365 Protease Substances 0.000 claims description 10
- 235000019418 amylase Nutrition 0.000 claims description 10
- 235000019835 bromelain Nutrition 0.000 claims description 10
- 229940059442 hemicellulase Drugs 0.000 claims description 10
- 108010002430 hemicellulase Proteins 0.000 claims description 10
- 239000000463 material Substances 0.000 claims description 10
- 238000005406 washing Methods 0.000 claims description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 9
- 208000008469 Peptic Ulcer Diseases 0.000 claims description 9
- 238000002791 soaking Methods 0.000 claims description 9
- 238000003756 stirring Methods 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 8
- 239000000047 product Substances 0.000 claims description 8
- 239000002994 raw material Substances 0.000 claims description 8
- 239000000706 filtrate Substances 0.000 claims description 7
- 229940095353 oral granules Drugs 0.000 claims description 7
- 238000010298 pulverizing process Methods 0.000 claims description 7
- 239000007944 soluble tablet Substances 0.000 claims description 7
- 235000008534 Capsicum annuum var annuum Nutrition 0.000 claims description 4
- 235000019510 Long pepper Nutrition 0.000 claims description 4
- 240000003455 Piper longum Species 0.000 claims description 4
- 240000005746 Ruta graveolens Species 0.000 claims description 3
- 235000001347 Ruta graveolens Nutrition 0.000 claims description 3
- 239000001229 ruta graveolens Substances 0.000 claims description 3
- 208000011906 peptic ulcer disease Diseases 0.000 claims 7
- 239000003480 eluent Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 24
- 210000001156 gastric mucosa Anatomy 0.000 abstract description 19
- 241000590002 Helicobacter pylori Species 0.000 abstract description 14
- 229940037467 helicobacter pylori Drugs 0.000 abstract description 14
- 210000004211 gastric acid Anatomy 0.000 abstract description 13
- 230000002401 inhibitory effect Effects 0.000 abstract description 10
- 229940079593 drug Drugs 0.000 abstract description 8
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- 230000001737 promoting effect Effects 0.000 abstract description 4
- 150000001875 compounds Chemical class 0.000 abstract description 2
- 230000001681 protective effect Effects 0.000 abstract description 2
- 208000025865 Ulcer Diseases 0.000 description 23
- 231100000397 ulcer Toxicity 0.000 description 23
- 230000000052 comparative effect Effects 0.000 description 20
- 210000002784 stomach Anatomy 0.000 description 15
- 229920002472 Starch Polymers 0.000 description 12
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- 230000005764 inhibitory process Effects 0.000 description 10
- 241000699670 Mus sp. Species 0.000 description 9
- 241001614060 Amynthas aspergillus Species 0.000 description 8
- 230000000844 anti-bacterial effect Effects 0.000 description 6
- 235000013305 food Nutrition 0.000 description 5
- 230000027119 gastric acid secretion Effects 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
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- 230000002708 enhancing effect Effects 0.000 description 2
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- 231100000820 toxicity test Toxicity 0.000 description 2
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 description 1
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 1
- 238000009631 Broth culture Methods 0.000 description 1
- 206010053155 Epigastric discomfort Diseases 0.000 description 1
- 206010015137 Eructation Diseases 0.000 description 1
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 1
- 241001632576 Hyacinthus Species 0.000 description 1
- 206010067482 No adverse event Diseases 0.000 description 1
- 208000005718 Stomach Neoplasms Diseases 0.000 description 1
- 241000301400 Trogopterus Species 0.000 description 1
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- 238000010521 absorption reaction Methods 0.000 description 1
- 229960001138 acetylsalicylic acid Drugs 0.000 description 1
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- 235000013399 edible fruits Nutrition 0.000 description 1
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 description 1
- 210000003608 fece Anatomy 0.000 description 1
- 239000008098 formaldehyde solution Substances 0.000 description 1
- 206010017758 gastric cancer Diseases 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
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- 229940047522 long pepper extract Drugs 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000007102 metabolic function Effects 0.000 description 1
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- 231100000957 no side effect Toxicity 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 229960000381 omeprazole Drugs 0.000 description 1
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- 235000019633 pungent taste Nutrition 0.000 description 1
- 229960004157 rabeprazole Drugs 0.000 description 1
- YREYEVIYCVEVJK-UHFFFAOYSA-N rabeprazole Chemical compound COCCCOC1=CC=NC(CS(=O)C=2NC3=CC=CC=C3N=2)=C1C YREYEVIYCVEVJK-UHFFFAOYSA-N 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
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- 210000001519 tissue Anatomy 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/82—Theaceae (Tea family), e.g. camellia
-
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/08—Oxides; Hydroxides
-
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/62—Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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- A61K2236/10—Preparation or pretreatment of starting material
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
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Abstract
The invention relates to a therapeutic pharmaceutical composition for peptic gastric ulcer and a preparation method thereof, belonging to the technical field of medicines, wherein the pharmaceutical composition contains a starter propagation extract, a white jade snail extract, camellia seed oil, an eichhornia crassipes extract, a cubeba extract, sodium bicarbonate and magnesium oxide; wherein the Pheretima extract is the enzymolysis product of Pheretima sequentially passing through pepsin and trypsin; the white jade snail extract is the enzymolysis product of white jade snail mucus by pepsin. The invention starts from various factors such as inhibiting helicobacter pylori, inhibiting gastric acid and pepsin secretion, repairing gastric mucosa, promoting digestion and the like, reasonably compounds the rice-roller extract, the white jade snail extract, the camellia seed oil, the eichhornia crassipes extract, the fructus cubeba extract, the sodium bicarbonate and the magnesium oxide, designs a special preparation method of the extract, has the effect of rapidly treating gastric ulcer, can repair and strengthen the gastric mucosa protective barrier effect, ensures that the gastric ulcer is not easy to repeatedly attack, and is safe and free of side effects.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a pharmaceutical composition for treating peptic gastric ulcer and a preparation method thereof.
Background
Gastric acid, pepsin and other substances can be secreted in the process of digesting food, so that the gastric acid, pepsin and other substances are used for helping to digest food quickly, but gastric acid, pepsin and other substances are also attack factors, when gastric acid, pepsin are secreted too much or gastric mucosa protecting function is weakened, gastric acid, pepsin can invade and stimulate cell tissues below a mucosa layer to damage gastric mucosa to form ulcers, namely, erosion of the mucosa occurs, complications such as perforation bleeding and the like can occur when the erosion is serious, and gastric cancer can also be caused. Therefore, it is important to keep the gastric mucosa healthy, have a good barrier effect, maintain the proper secretion of gastric acid and pepsin, balance the equilibrium of both, and ensure a healthy digestive system. In addition, the stomach is the main site of helicobacter pylori colonization, helicobacter pylori infection is also an important cause of the induction of ulcers, and about 80% of gastric ulcers are caused by helicobacter pylori infection, so that killing and prevention of helicobacter pylori infection are also necessary.
The symptoms of peptic ulcers are typically gastric distension, stomach pain, eructation, acid regurgitation, nausea and vomiting. Treatment of peptic ulcers is generally divided into conditioning and medication modes: the conditioning mode refers to the adjustment of dietary structure and life rule, smoking cessation, alcohol withdrawal, pungency, light and digestible food selection, and sufficient intake of nutrition; the people do not need to stay up night, do not need to drink and eat violently, and develop good living habits. The drug therapy may be selected from drugs that reduce gastric acid secretion, and inhibit gastric acid secretion, such as omeprazole, sodium rabeprazole, and the like. However, the medicines for inhibiting gastric acid secretion treat symptoms but not root causes, and have poor curative effects on the aspects of repairing mucous membrane and enhancing mucous membrane protection function; and drugs inhibiting gastric acid secretion affect digestive metabolism, and have adverse side effects such as abdominal pain, nausea, rash, etc., with poor safety.
Disclosure of Invention
Aiming at the defect of poor curative effect of the existing therapeutic drugs for peptic gastric ulcer in repairing mucous membrane and enhancing mucous membrane protecting function, and the defect of adverse side effects such as abdominal pain, nausea, rash and the like caused by the influence of drugs for inhibiting gastric acid secretion on digestive metabolism function, the safety is poor. The invention provides a therapeutic pharmaceutical composition for peptic gastric ulcer and a preparation method thereof, which are characterized in that from various factors such as helicobacter pylori inhibition, gastric acid and pepsin secretion inhibition, gastric mucosa repair, digestion promotion and the like, a roller extract, a white jade snail extract, camellia seed oil, a hyacinth fruit extract, a long pepper extract, sodium bicarbonate and magnesium oxide are reasonably compounded, and a special extract preparation method is designed. The specific technical scheme is as follows:
A therapeutic pharmaceutical composition for peptic gastric ulcer is prepared from the following raw materials in parts by mass: 1 to 3 parts of a common rue herb extract, 1 to 3 parts of a white jade snail extract, 0.2 to 0.5 part of camellia seed oil, 0.5 to 1.5 parts of an eichhornia crassipes extract, 0.5 to 1.5 parts of a long pepper cubeba extract, 0.3 to1 part of sodium bicarbonate and 0.5 to 1.5 parts of magnesium oxide;
the Pheretima extract is an enzymolysis product of Pheretima sequentially subjected to pepsin and trypsin; the white jade snail extract is an enzymolysis product of white jade snail mucus by pepsin.
In the above technical scheme, the preparation method of the qu-earth-pressure extract comprises the following steps: cleaning and crushing the starter, crushing into slurry, adding water 3-5 times the mass of the slurry, uniformly mixing, adding hydrochloric acid to adjust the pH value to 1.5-2, adding pepsin, carrying out enzymolysis for 1-1.5 hours at 37-40 ℃, heating in water bath to deactivate enzyme, reducing the temperature to 36-38 ℃, adding sodium hydroxide to adjust the pH value to 7.5-8.0, adding trypsin, carrying out enzymolysis for 1-2 hours, heating in water bath to deactivate enzyme, reducing the temperature to room temperature, adopting a30 kDa ultrafiltration membrane to filter, collecting liquid with the pH value less than 30kDa, and freeze-drying to obtain the starter extract.
The addition amount of the pepsin is 1% -5% of the mass of the slurry; the adding amount of the trypsin is 1% -5% of the mass of the slurry; the temperature of the water bath for heating and inactivating enzyme is above 90 ℃ for 15-30 min.
In the technical scheme, the preparation method of the white jade snail extract comprises the following steps: removing shells of white jade snails to obtain white jade snail bodies, repeatedly cleaning the white jade snail bodies with water 3-5 times of the white jade snail bodies until mucus of the white jade snail bodies is eluted to obtain mucus, washing and dehydrating, adding hydrochloric acid into the mucus eluting water to adjust the pH value to 1.5-2, then adding pepsin, carrying out enzymolysis for 1-1.5 hours at 37-40 ℃, heating in water bath to inactivate enzymes, cooling to room temperature, concentrating, and freeze-drying to obtain snail extracts.
The addition amount of the pepsin is 1% -3% of the mass of the mucus eluting water; the temperature of the water bath for heating and inactivating enzyme is above 90 ℃ for 15-30 min.
In the above technical scheme, the preparation method of the eichhornia crassipes extract comprises the following steps: crushing the eichhornia crassipes, adding water with the mass of 4-6 times of the eichhornia crassipes, regulating the pH value to 4.8-5.2, adding hemicellulase, carrying out enzymolysis for 1-2 hours at 50-60 ℃, heating in water bath to deactivate enzyme, reducing the temperature to 40-45 ℃, regulating the pH value to 6.5-7.2, adding bromelain and salivary amylase, carrying out enzymolysis for 1-2 hours, heating in water bath to deactivate enzyme, reducing the temperature to room temperature, filtering by adopting a 5kDa ultrafiltration membrane, collecting liquid with the concentration of below 5kDa, concentrating, and freeze-drying to obtain the eichhornia crassipes extract.
The addition amount of the hemicellulase is 0.5% -2% of the quality of the eichhornia crassipes; the addition amount of the bromelain and the salivary amylase is 0.5-2% of the mass of the eichhornia crassipes; the temperature of the water bath for heating and inactivating enzyme is above 90 ℃ for 15-30 min.
In the technical scheme, the preparation method of the fructus piperis cubeba extract comprises the following steps: pulverizing fructus Litseae, adding water 5-8 times of fructus Litseae, mixing, adding hydrochloric acid to adjust pH to 1.5-2, adding pepsin, performing enzymolysis at 37-40deg.C for 1-2 hr, heating in water bath to deactivate enzyme, cooling to room temperature, adding absolute ethanol, stirring, mixing, soaking, filtering with 500 mesh sieve, collecting filtrate, concentrating, and freeze drying to obtain fructus Litseae extract.
The addition amount of the pepsin is 1% -3% of the mass of the fructus cubeba; the temperature of the water bath for heating and inactivating enzyme is above 90 ℃ for 15-30 min; the addition amount of the absolute ethyl alcohol is 2-4 times of the mass of the fructus cubeba, and the stirring, mixing and soaking time is 1-2 hours.
The preparation method of the pharmaceutical composition for treating the peptic gastric ulcer comprises the following steps:
S1: 1 to 3 parts of a curved-spike-shaped extractive, 1 to 3 parts of a white jade snail extractive, 0.2 to 0.5 part of camellia seed oil, 0.5 to 1.5 parts of an eichhornia crassipes extractive, 0.5 to 1.5 parts of a fructus piperis cubeba extractive, 0.3 to 1 part of sodium bicarbonate and 0.5 to 1.5 parts of magnesium oxide; firstly, uniformly mixing sodium bicarbonate and magnesium oxide, then sequentially adding an eichhornia crassipes extract and a fructus cubeba extract for uniform mixing, and finally, adding a field-roller extract, a snail extract and camellia seed oil for uniform mixing to obtain a pharmaceutical composition;
s2: the medicine composition is compounded with pharmaceutically acceptable auxiliary materials to prepare gastric-soluble tablets, gastric-soluble capsules or oral granules.
Compared with the prior art, the pharmaceutical composition for treating the peptic gastric ulcer and the preparation method thereof have the beneficial effects that:
1. The pharmaceutical composition of the invention contains a common rue herb extract, a white jade snail extract, camellia seed oil, an eichhornia crassipes extract, a fructus cubeba extract, sodium bicarbonate and magnesium oxide. Wherein sodium bicarbonate and magnesium oxide have the effect of inhibiting gastric acid and pepsin secretion; camellia seed oil has helicobacter pylori inhibiting effect; the Pheretima extract and white jade snail extract have the effect of rapidly repairing gastric mucosa; the Eichhornia crassipes extract and the fructus Litseae extract have a certain inhibiting effect on helicobacter pylori, can greatly improve the inactivating property of helicobacter pylori, do not stimulate the stomach, and have the effects of nourishing the stomach and promoting digestion.
2. The invention designs a preparation method of the Pheretima extract, wherein the Pheretima is subjected to enzymolysis by pepsin and trypsin at one time, and the Pheretima extract with the molecular weight of less than 30kDa is collected, so that the irritation to the stomach and the secretion of gastric acid and pepsin can be reduced, meanwhile, the Pheretima extract is a mucinous product which is absorbed in the stomach and can be absorbed through ulcer surfaces, the Pheretima extract has the effects of directly and efficiently repairing gastric mucosa, the gastric mucosa repair is faster, the gastric mucosa protection barrier is improved, and the gastric mucosa health is maintained.
3. The invention designs a preparation method of the white jade snail extract, which takes mucus of the white jade snail, carries out pepsin enzymolysis, and the product after pepsin enzymolysis can reduce the stimulation to the stomach and reduce the secretion of gastric acid and pepsin, and meanwhile, the mucus extract of the white jade snail is a mucinous product, has high absorption speed in the stomach and can also be absorbed through ulcer surfaces, has the function of directly and efficiently repairing gastric mucosa, and ensures that the gastric mucosa is repaired more quickly; the white jade snail extract and the trogopterus dung extract are matched for use, so that the repairing effect of gastric mucosa can be greatly improved, and ulcer repetition is prevented.
4. The invention designs a preparation method of the Eichhornia crassipes extract, which is characterized in that the Eichhornia crassipes extract is subjected to enzymolysis by adopting hemicellulase, and then is subjected to enzymolysis by adopting bromelain and salivary amylase, so that the Eichhornia crassipes extract below 5kD is obtained, has a good stomach nourishing effect, has no irritation to stomach, can directly absorb part of components in the stomach, has the effects of promoting digestion, relieving pain, relieving gastrectasia and belch, and can inhibit helicobacter pylori.
5. The invention designs a preparation method of a fructus cubeba extract, which comprises the steps of carrying out enzymolysis on fructus cubeba by pepsin, and then extracting a dissolved substance of an ethanol water solution and solid components below a 500-mesh screen. The product obtained after pepsin enzymolysis has lower gastric irritation, can reduce gastric acid and pepsin secretion, has the effects of invigorating stomach, resolving food stagnation, dispelling cold and relieving pain, can be rapidly absorbed in stomach, has quicker treatment, shortens treatment course, and can inhibit helicobacter pylori. The fructus Litseae extract and Eichhornia crassipes extract can be used together to greatly improve gastric ulcer treatment effect caused by helicobacter pylori, and can assist the Pheretima aspergillum extract and white jade snail extract in repairing gastric mucosa.
In conclusion, the application reasonably compounds the qu-shi extract, the white jade snail extract, the camellia seed oil, the eichhornia crassipes extract, the long pepper cubeba extract, the sodium bicarbonate and the magnesium oxide from various factors such as inhibiting helicobacter pylori, inhibiting gastric acid and pepsin secretion, repairing gastric mucosa, promoting digestion and the like, has the effect of quickly treating gastric ulcer, can repair and strengthen the protective barrier effect of the gastric mucosa, ensures that the gastric ulcer is not easy to repeatedly attack, is safe and has no side effect, and has good medicinal value.
Detailed Description
The invention will be further illustrated with reference to specific examples, but the invention is not limited to these examples.
Example 1
A therapeutic pharmaceutical composition for peptic gastric ulcer is prepared from the following raw materials in parts by mass: 2 parts of a Pheretima extract, 2 parts of a white jade snail extract, 0.3 part of camellia seed oil, 1 part of an Eichhornia crassipes extract, 1 part of a fructus Litseae extract, 0.5 part of sodium bicarbonate and 0.8 part of magnesium oxide;
Wherein, the preparation method of the Pheretima aspergillum extract comprises the following steps: cleaning and crushing the starter, crushing into slurry, adding water with the mass being 4 times that of the slurry, uniformly mixing, adding hydrochloric acid to adjust the pH value to 1.8, adding pepsin with the mass being 3% of the slurry, carrying out enzymolysis at 38 ℃ for 1h, heating in a water bath to 92 ℃ for inactivating enzyme for 20min, cooling to 37 ℃, adding sodium hydroxide to adjust the pH value to 7.8, adding trypsin with the mass being 3% of the slurry, carrying out enzymolysis for 1.5h, heating in the water bath for inactivating enzyme, cooling to room temperature, adopting a 30kDa ultrafiltration membrane to filter, collecting liquid with the mass being less than 30kDa, and freeze-drying to obtain a starter extract;
The preparation method of the white jade snail extract comprises the following steps: removing shell of white jade snail to obtain white jade snail body, repeatedly washing white jade snail body with water 4 times of the white jade snail body until mucus of white jade snail body is eluted to obtain mucus, washing and dehydrating, adding hydrochloric acid into mucus eluting water to adjust pH value to 1.8, adding pepsin 2% of the mass of mucus eluting water, performing enzymolysis at 38deg.C for 1 hr, heating in water bath to 92 deg.C for inactivating enzyme for 20min, cooling to room temperature, concentrating, and freeze drying to obtain snail extract;
The preparation method of the eichhornia crassipes extract comprises the following steps: crushing Eichhornia crassipes, adding water with the mass 5 times of that of the Eichhornia crassipes, regulating the pH value to 5.0, adding hemicellulase with the mass 1% of the Eichhornia crassipes, carrying out enzymolysis at 55 ℃ for 1h, heating in a water bath to deactivate enzyme, reducing the temperature to 42 ℃, regulating the pH value to 6.8, adding bromelain with the mass 1% of the Eichhornia crassipes and salivary amylase with the mass 1% of the Eichhornia crassipes, carrying out enzymolysis for 1h, heating in the water bath to 92 ℃ to deactivate enzyme for 20min, reducing the temperature to room temperature, adopting a 5kDa ultrafiltration membrane to filter, collecting liquid with the mass less than 5kDa, concentrating, and freeze-drying to obtain an Eichhornia crassipes extract;
Wherein, the preparation method of the fructus Litseae extract comprises the following steps: pulverizing fructus Litseae, adding water 6 times of fructus Litseae, mixing, adding hydrochloric acid to adjust pH to 1.8, adding pepsin 2% of fructus Litseae, performing enzymolysis at 38deg.C for 1 hr, heating in water bath to 92 deg.C for inactivating enzyme for 20min, cooling to room temperature, adding absolute ethanol 3 times of fructus Litseae, stirring, mixing, soaking for 1 hr, filtering with 500 mesh sieve, collecting filtrate, concentrating, and lyophilizing to obtain fructus Litseae extract.
The preparation method of the pharmaceutical composition for treating the peptic gastric ulcer comprises the following steps:
S1: according to the mass parts, 2 parts of a common-mode wheel herb extract, 2 parts of a white jade snail extract, 0.3 part of camellia seed oil, 1 part of an eichhornia crassipes extract, 1 part of a fructus cubeba extract, 0.5 part of sodium bicarbonate and 0.8 part of magnesium oxide; firstly, uniformly mixing sodium bicarbonate and magnesium oxide, then sequentially adding the eichhornia crassipes extract and the fructus cubeba extract for uniform mixing, and finally, adding the field-roller extract, the snail extract and the camellia seed oil for uniform mixing to obtain the pharmaceutical composition.
S2: the medicine composition is compounded with pharmaceutically acceptable auxiliary materials to prepare gastric-soluble tablets, gastric-soluble capsules or oral granules.
In the embodiment, the pharmaceutical composition is prepared into a gastric-soluble capsule sample, the specification of the capsule is No. 1, and each capsule contains 0.1g of the pharmaceutical composition and the balance of starch.
Example 2
A therapeutic pharmaceutical composition for peptic gastric ulcer is prepared from the following raw materials in parts by mass: 3 parts of a Pheretima extract, 3 parts of a white jade snail extract, 0.5 part of camellia seed oil, 1.5 parts of an Eichhornia crassipes extract, 1.5 parts of a fructus Litseae extract, 1 part of sodium bicarbonate and 1.5 parts of magnesium oxide;
Wherein, the preparation method of the Pheretima aspergillum extract comprises the following steps: cleaning and crushing the starter propagation into slurry, adding water with the mass being 5 times that of the slurry, uniformly mixing, adding hydrochloric acid to adjust the pH value to 2, adding pepsin with the mass being 5% of the slurry, carrying out enzymolysis at 40 ℃ for 1.5 hours, heating in a water bath to 100 ℃ for inactivating enzyme for 30 minutes, cooling to 38 ℃, adding sodium hydroxide to adjust the pH value to 8.0, then adding trypsin with the mass being 5% of the slurry, carrying out enzymolysis for 2 hours, heating in the water bath for inactivating enzyme, cooling to room temperature, filtering by adopting a 30kDa ultrafiltration membrane, collecting liquid with the mass being less than 30kDa, and freeze-drying to obtain a starter propagation extract;
The preparation method of the white jade snail extract comprises the following steps: removing shell of white jade snail to obtain white jade snail body, repeatedly washing white jade snail body with water 5 times of the white jade snail body until mucus of white jade snail body is eluted to obtain mucus, washing and dehydrating, adding hydrochloric acid into mucus eluting water to adjust pH value to 2, adding pepsin 3% of the mass of mucus eluting water, performing enzymolysis at 40deg.C for 1.5 hr, heating in water bath to 100deg.C for inactivating enzyme for 30min, cooling to room temperature, concentrating, and freeze drying to obtain snail extract;
The preparation method of the eichhornia crassipes extract comprises the following steps: crushing Eichhornia crassipes, adding water with the mass of 6 times of that of the Eichhornia crassipes, regulating the pH value to 5.2, adding hemicellulase with the mass of 2% of the Eichhornia crassipes, carrying out enzymolysis at 60 ℃ for 2 hours, heating up to deactivate enzyme in a water bath, reducing the temperature to 45 ℃, regulating the pH value to 7.2, adding bromelain with the mass of 2% of the Eichhornia crassipes and salivary amylase with the mass of 2% of the Eichhornia crassipes, carrying out enzymolysis for 2 hours, heating up to 90 ℃ in the water bath to deactivate enzyme for 30 minutes, reducing the temperature to room temperature, adopting a 5kDa ultrafiltration membrane to filter, collecting liquid with the mass of less than 5kDa, concentrating, and freeze-drying to obtain an Eichhornia crassipes extract;
Wherein, the preparation method of the fructus Litseae extract comprises the following steps: pulverizing fructus Litseae, adding 8 times of water, mixing, adding hydrochloric acid to adjust pH to 2, adding pepsin 3% of fructus Litseae, performing enzymolysis at 40deg.C for 2 hr, heating in water bath to 90deg.C for inactivating enzyme for 30min, cooling to room temperature, adding 4 times of absolute ethanol of fructus Litseae, stirring, mixing, soaking for 2 hr, filtering with 500 mesh sieve, collecting filtrate, concentrating, and lyophilizing to obtain fructus Litseae extract.
The preparation method of the pharmaceutical composition for treating the peptic gastric ulcer comprises the following steps:
S1: according to the mass parts, 3 parts of a common-mode wheel herb extract, 3 parts of a white jade snail extract, 0.5 part of camellia seed oil, 1.5 parts of an eichhornia crassipes extract, 1.5 parts of a fructus piperis cubeba extract, 1 part of sodium bicarbonate and 1.5 parts of magnesium oxide; firstly, uniformly mixing sodium bicarbonate and magnesium oxide, then sequentially adding the eichhornia crassipes extract and the fructus cubeba extract for uniform mixing, and finally, adding the field-roller extract, the snail extract and the camellia seed oil for uniform mixing to obtain the pharmaceutical composition.
S2: the medicine composition is compounded with pharmaceutically acceptable auxiliary materials to prepare gastric-soluble tablets, gastric-soluble capsules or oral granules.
In the embodiment, the pharmaceutical composition is prepared into a gastric-soluble capsule sample, the specification of the capsule is No. 1, and each capsule contains 0.1g of the pharmaceutical composition and the balance of starch.
Example 3
A therapeutic pharmaceutical composition for peptic gastric ulcer is prepared from the following raw materials in parts by mass: 1 part of a Pheretima extract, 1 part of a white jade snail extract, 0.2 part of camellia seed oil, 0.5 part of an Eichhornia crassipes extract, 0.5 part of a fructus Litseae extract, 0.3 part of sodium bicarbonate and 0.5 part of magnesium oxide;
Wherein, the preparation method of the Pheretima aspergillum extract comprises the following steps: cleaning and crushing the starter, crushing into slurry, adding water 3 times the mass of the slurry, uniformly mixing, adding hydrochloric acid to adjust the pH value to 1.5, adding pepsin with the mass of the slurry, carrying out enzymolysis for 1h at 37 ℃, heating up to 95 ℃ in a water bath to inactivate enzyme for 15min, cooling to 36 ℃, adding sodium hydroxide to adjust the pH value to 7.5, adding trypsin with the mass of the slurry to carry out enzymolysis for 1h, heating up to inactivate enzyme in the water bath, cooling to room temperature, filtering by adopting a 30kDa ultrafiltration membrane, collecting liquid with the mass of less than 30kDa, and freeze-drying to obtain a starter extract;
The preparation method of the white jade snail extract comprises the following steps: removing shell of white jade snail to obtain white jade snail body, repeatedly washing white jade snail body with water 3 times of the white jade snail body until mucus of white jade snail body is eluted to obtain mucus, washing and dehydrating, adding hydrochloric acid into mucus eluting water to adjust pH value to 1.5, adding pepsin 1% of the mass of mucus eluting water, performing enzymolysis at 37deg.C for 1 hr, heating in water bath to 95deg.C for inactivating enzyme for 15min, cooling to room temperature, concentrating, and freeze drying to obtain snail extract;
The preparation method of the eichhornia crassipes extract comprises the following steps: crushing Eichhornia crassipes, adding water with the mass 4 times of that of the Eichhornia crassipes, regulating the pH value to 4.8, adding hemicellulase with the mass 0.5% of that of the Eichhornia crassipes, carrying out enzymolysis at 50 ℃ for 1h, heating up to deactivate enzyme in a water bath, reducing the temperature to 40 ℃, regulating the pH value to 6.5, adding bromelain with the mass 0.5% of that of the Eichhornia crassipes and salivary amylase with the mass 0.5% of that of the Eichhornia crassipes, carrying out enzymolysis for 1h, heating up to 95 ℃ in the water bath to deactivate enzyme for 15min, cooling to room temperature, filtering by adopting a 5kDa ultrafiltration membrane, collecting liquid with the mass less than 5kDa, concentrating, and freeze-drying to obtain an Eichhornia crassipes extract;
Wherein, the preparation method of the fructus Litseae extract comprises the following steps: pulverizing fructus Litseae, adding water 5 times of fructus Litseae, mixing, adding hydrochloric acid to adjust pH to 1.5, adding pepsin 1% of fructus Litseae, performing enzymolysis at 37deg.C for 1 hr, heating in water bath to 95deg.C for inactivating enzyme for 15min, cooling to room temperature, adding anhydrous ethanol 2 times-4 times of fructus Litseae, stirring, mixing, soaking for 1 hr, filtering with 500 mesh sieve, collecting filtrate, concentrating, and lyophilizing to obtain fructus Litseae extract.
The preparation method of the pharmaceutical composition for treating the peptic gastric ulcer comprises the following steps:
S1: 1 part of a common-earth-herb extract, 1 part of a white jade snail extract, 0.2 part of camellia seed oil, 0.5 part of an eichhornia crassipes extract, 0.5 part of a long pepper cubeba extract, 0.3 part of sodium bicarbonate and 0.5 part of magnesium oxide; firstly, uniformly mixing sodium bicarbonate and magnesium oxide, then sequentially adding the eichhornia crassipes extract and the fructus cubeba extract for uniform mixing, and finally, adding the field-roller extract, the snail extract and the camellia seed oil for uniform mixing to obtain the pharmaceutical composition.
S2: the medicine composition is compounded with pharmaceutically acceptable auxiliary materials to prepare gastric-soluble tablets, gastric-soluble capsules or oral granules.
In the embodiment, the pharmaceutical composition is prepared into a gastric-soluble capsule sample, the specification of the capsule is No. 1, and each capsule contains 0.1g of the pharmaceutical composition and the balance of starch.
Example 4
A therapeutic pharmaceutical composition for peptic gastric ulcer is prepared from the following raw materials in parts by mass: 1.5 parts of a Pheretima aspergillum extract, 1 part of a white jade snail extract, 0.25 part of camellia seed oil, 0.8 part of an Eichhornia crassipes extract, 0.6 part of a fructus Litseae extract, 0.4 part of sodium bicarbonate and 0.6 part of magnesium oxide;
Wherein, the preparation method of the Pheretima aspergillum extract comprises the following steps: cleaning and crushing the starter, crushing into slurry, adding water with the mass being 3.5 times that of the slurry, uniformly mixing, adding hydrochloric acid to adjust the pH value to 1.6, adding pepsin with the mass being 1.5% of that of the slurry, carrying out enzymolysis at 37 ℃ for 1h, heating in a water bath to 90 ℃ for inactivating enzyme for 15min, cooling to 37 ℃, adding sodium hydroxide to adjust the pH value to 7.6, adding trypsin with the mass being 1.5% of that of the slurry, carrying out enzymolysis for 1h, heating in the water bath for inactivating enzyme, cooling to room temperature, adopting a 30kDa ultrafiltration membrane to filter, collecting liquid with the mass being below 30kDa, and freeze-drying to obtain a starter extract;
The preparation method of the white jade snail extract comprises the following steps: removing shell of white jade snail to obtain white jade snail body, repeatedly cleaning white jade snail body with water 3.5 times of the white jade snail body until mucus of white jade snail body is eluted to obtain mucus, washing and dehydrating, adding hydrochloric acid into mucus eluting water to adjust pH value to 1.6, adding pepsin with 1.2% of the mass of mucus eluting water, performing enzymolysis at 37deg.C for 1 hr, heating in water bath to 90deg.C for inactivating enzyme for 18min, cooling to room temperature, concentrating, and freeze drying to obtain snail extract;
the preparation method of the eichhornia crassipes extract comprises the following steps: crushing Eichhornia crassipes, adding water with the mass of 4.5 times of that of the Eichhornia crassipes, regulating the pH value to 4.9, adding hemicellulase with the mass of 0.8% of that of the Eichhornia crassipes, carrying out enzymolysis at 52 ℃ for 1h, heating in a water bath to deactivate enzyme, reducing the temperature to 42 ℃, regulating the pH value to 6.6, adding bromelain with the mass of 0.8% of that of the Eichhornia crassipes and salivary amylase with the mass of 0.8% of that of the Eichhornia crassipes, carrying out enzymolysis for 1h, heating in the water bath to 90 ℃ to deactivate enzyme for 15min, cooling to room temperature, filtering by adopting a 5kDa ultrafiltration membrane, collecting liquid with the mass of less than 5kDa, concentrating, and freeze-drying to obtain an Eichhornia crassipes extract;
wherein, the preparation method of the fructus Litseae extract comprises the following steps: pulverizing fructus Litseae, adding water 5.5 times of fructus Litseae, mixing, adding hydrochloric acid to adjust pH to 1.6, adding pepsin 1.2% of fructus Litseae, performing enzymolysis at 37deg.C for 1 hr, heating in water bath to 90deg.C for inactivating enzyme for 18min, cooling to room temperature, adding absolute ethanol 2.5 times of fructus Litseae, stirring, mixing, soaking for 1.5 hr, filtering with 500 mesh sieve, collecting filtrate, concentrating, and lyophilizing to obtain fructus Litseae extract.
The preparation method of the pharmaceutical composition for treating the peptic gastric ulcer comprises the following steps:
s1: 1.5 parts of a rice-flour-paste-mixture extract, 1 part of a white jade snail extract, 0.25 part of camellia seed oil, 0.8 part of an eichhornia crassipes extract, 0.6 part of a fructus piperis cubeba extract, 0.4 part of sodium bicarbonate and 0.6 part of magnesium oxide; firstly, uniformly mixing sodium bicarbonate and magnesium oxide, then sequentially adding the eichhornia crassipes extract and the fructus cubeba extract for uniform mixing, and finally, adding the field-roller extract, the snail extract and the camellia seed oil for uniform mixing to obtain the pharmaceutical composition.
S2: the medicine composition is compounded with pharmaceutically acceptable auxiliary materials to prepare gastric-soluble tablets, gastric-soluble capsules or oral granules.
In the embodiment, the pharmaceutical composition is prepared into a gastric-soluble capsule sample, the specification of the capsule is No. 1, and each capsule contains 0.1g of the pharmaceutical composition and the balance of starch.
Example 5
A therapeutic pharmaceutical composition for peptic gastric ulcer is prepared from the following raw materials in parts by mass: 2.5 parts of a Pheretima aspergillum extract, 2.2 parts of a white jade snail extract, 0.4 part of camellia seed oil, 1.2 parts of an Eichhornia crassipes extract, 1.4 parts of a fructus Litseae extract, 0.8 part of sodium bicarbonate and 1.2 parts of magnesium oxide;
Wherein, the preparation method of the Pheretima aspergillum extract comprises the following steps: cleaning and crushing the starter, crushing into slurry, adding water with the mass being 4.5 times that of the slurry, uniformly mixing, adding hydrochloric acid to adjust the pH value to 1.8, adding pepsin with the mass being 4% of the slurry, carrying out enzymolysis at 39 ℃ for 1.5 hours, heating in a water bath to 95 ℃ for inactivating enzyme for 25 minutes, cooling to 37 ℃, adding sodium hydroxide to adjust the pH value to 7.8, adding trypsin with the mass being 4% of the slurry, carrying out enzymolysis for 1.5 hours, heating in the water bath for inactivating enzyme, cooling to room temperature, adopting a 30kDa ultrafiltration membrane for filtering, collecting liquid with the mass being less than 30kDa, and freeze-drying to obtain a starter extract;
The preparation method of the white jade snail extract comprises the following steps: removing shell of white jade snail to obtain white jade snail body, repeatedly cleaning white jade snail body with water 4.5 times of the white jade snail body until mucus of white jade snail body is eluted to obtain mucus, washing and dehydrating, adding hydrochloric acid into mucus eluting water to adjust pH value to 1.9, adding pepsin 2.5% of the mass of mucus eluting water, performing enzymolysis at 39deg.C for 1.5 hr, heating in water bath to 95deg.C for inactivating enzyme for 25min, cooling to room temperature, concentrating, and freeze drying to obtain snail extract;
The preparation method of the eichhornia crassipes extract comprises the following steps: crushing Eichhornia crassipes, adding water with the mass 5.5 times of that of the Eichhornia crassipes, regulating the pH value to 5.1, adding hemicellulase with the mass 1.6% of that of the Eichhornia crassipes, carrying out enzymolysis at 58 ℃ for 2 hours, heating up to deactivate enzyme in a water bath, reducing the temperature to 43 ℃, regulating the pH value to 7.1, adding bromelain with the mass 1.8% of that of the Eichhornia crassipes and salivary amylase with the mass 1.6% of that of the Eichhornia crassipes, carrying out enzymolysis for 2 hours, heating up to 90 ℃ in the water bath to deactivate enzyme for 25 minutes, cooling to room temperature, filtering by adopting a 5kDa ultrafiltration membrane, collecting liquid with the mass less than 5kDa, concentrating, and freeze-drying to obtain an Eichhornia crassipes extract;
Wherein, the preparation method of the fructus Litseae extract comprises the following steps: pulverizing fructus Litseae, adding water 7 times of fructus Litseae, mixing, adding hydrochloric acid to adjust pH to 1.9, adding pepsin 2.5% of fructus Litseae, performing enzymolysis at 39deg.C for 2 hr, heating in water bath to 90deg.C for inactivating enzyme for 25min, cooling to room temperature, adding absolute ethanol 3.5 times of fructus Litseae, stirring, mixing, soaking for 2 hr, filtering with 500 mesh sieve, collecting filtrate, concentrating, and lyophilizing to obtain fructus Litseae extract.
The preparation method of the pharmaceutical composition for treating the peptic gastric ulcer comprises the following steps:
S1: 2.5 parts of a rice-flour-center-wheel extract, 2.2 parts of a white jade snail extract, 0.4 part of camellia seed oil, 1.2 parts of an eichhornia crassipes extract, 1.4 parts of a fructus cubeba extract, 0.8 part of sodium bicarbonate and 1.2 parts of magnesium oxide; firstly, uniformly mixing sodium bicarbonate and magnesium oxide, then sequentially adding the eichhornia crassipes extract and the fructus cubeba extract for uniform mixing, and finally, adding the field-roller extract, the snail extract and the camellia seed oil for uniform mixing to obtain the pharmaceutical composition.
S2: the medicine composition is compounded with pharmaceutically acceptable auxiliary materials to prepare gastric-soluble tablets, gastric-soluble capsules or oral granules.
In the embodiment, the pharmaceutical composition is prepared into a gastric-soluble capsule sample, the specification of the capsule is No. 1, and each capsule contains 0.1g of the pharmaceutical composition and the balance of starch.
Preparation of comparative example 1
The Pheretima extract was replaced with starch, and the other methods and parameters were the same as in example 1.
Preparation of comparative example 2
The white jade snail extract was replaced with starch, and the other methods and parameters were the same as in example 1.
Preparation of comparative example 3
The Pheretima extract and white jade snail extract were replaced with starch, and the other methods and parameters were the same as in example 1.
Preparation of comparative example 4
The Eichhornia crassipes extract and the Litsea cubeba extract were replaced with starch, and other methods and parameters were the same as in example 1.
Experiment one, toxicity test:
The pharmaceutical compositions of examples 1-5 were subjected to acute gastric lavage toxicity test in mice, 150 mice were equally divided into 5 groups of 30 mice each, the gastric lavage pharmaceutical composition was 0.02g/kg, and the reaction conditions were observed, and the pharmaceutical compositions of examples all had no adverse reaction; mice were fed daily at 0.02g/kg for 15 consecutive days, and examined for no abnormal phenomenon in the viscera, and as a result, were negative and harmless. The raw materials are all ingredients which are allowed to be added in medicines or foods.
Experiment two, helicobacter pylori in vitro bacteriostasis test:
Helicobacter pylori (ATCC 43504) was cultured at 37℃for 24 hours using a broth culture, then 5mL of several aliquots of the culture were taken, 0.05g of each bacteriostatic sample (bacteriostatic sample comprising the pharmaceutical composition of example 1 to example 5, the composition of comparative example 1 to comparative example 4, the Eichhornia crassipes extract of example 1, the Litsea cubeba extract of example 1) was added, 3 replicates each were prepared, and 3 replicates were prepared using 0.05g of starch as a blank; then culturing at 37 ℃ for 5min; the bacterial count in the culture solution before and after the measurement is carried out by adopting a plate method, and the bacteriostasis rate is calculated: antibacterial ratio= (number of bacteria before culture-number of bacteria after culture)/number of bacteria before culture×100%; the results are shown in Table 1 below.
TABLE 1 antibacterial Rate test results (average value) of helicobacter pylori
| Sample preparation | Antibacterial rate | Sample preparation | Antibacterial rate |
| Example 1 composition | 96.7% | Comparative example 1 composition | 94.6% |
| Example 2 composition | 97.3% | Comparative example 2 composition | 95.8% |
| Example 3 composition | 95.2% | Comparative example 3 composition | 95.4% |
| Example 4 composition | 94.5% | Comparative example 4 composition | 75.6% |
| Example 5 composition | 96.4% | Starch | -0.02% |
| Eichhornia crassipes extract | 72.3% | ||
| Fructus Litseae extract | 68.4% |
From the results, the Eichhornia crassipes extract and the fructus Litseae extract have certain antibacterial effect on helicobacter pylori, and can improve the antibacterial effect of the pharmaceutical composition after being added into the pharmaceutical composition.
Experiment three, gastric ulcer inhibition test:
100 healthy mice are selected and randomly divided into 10 groups, and 10 groups (male and female halves) are respectively and correspondingly dosed with the compositions of the examples 1 to 5, the comparative examples 1 to 4 and the starch control group; the dosage is 0.02g/kg, 1 time a day, 3 days continuously, 30min after the last dosage, 150mg/kg of gastric aspirin, 4 hours later, the mice are sacrificed, the abdominal cavity of the mice is opened, the stomach is taken out and immersed in 1% formaldehyde solution, after 40min, the stomach is dissected along the large curve of the stomach, the gastric ulcer area is observed in an anatomic way, the ulcer index is counted, and the ulcer inhibition rate is calculated, wherein the single ulcer index: the length of the strip-rope-shaped ulcer is greater than 1mm, and the length is measured to be 1 minute per mm; if the width is larger than 1mm, doubling the score according to the millimeter number of the width; the length and width of the material are smaller than 1mm and larger than 0.5 mm, respectively, and the material is smaller than 0.5 and mm, respectively, and the material is smaller than 0.5 and 0.25; the score was added to obtain the ulcer index of the mice. The average ulcer index is the average of the sum of the ulcer points of each group of mice. Ulcer inhibition (%) = (control ulcer index-administration ulcer index)/control ulcer index×100%. The test calculation results are shown in table 2 below.
TABLE 2 gastric ulcer inhibition results (average)
| Sample preparation | Ulcer inhibition rate | Sample preparation | Ulcer inhibition rate |
| Example 1 composition | 60.2% | Comparative example 1 composition | 36.8% |
| Example 2 composition | 62.3% | Comparative example 2 composition | 45.8% |
| Example 3 composition | 56.8% | Comparative example 3 composition | 30.5% |
| Example 4 composition | 57.2% | Comparative example 4 composition | 57.3% |
| Example 5 composition | 59.4% |
From the above results, it is apparent that the extract of the rice bran and the extract of the snail have good inhibition effect on gastric ulcer, and the inhibition effect on gastric ulcer can be greatly improved by using the extract of the rice bran and the extract of the snail together with other components.
Experiment four, human body treatment evaluation test:
90 patients with gastric ulcer (26-42 years old) were selected and randomly divided into 9 groups of 10 persons (5 men and 5 women); each group corresponds to taking the capsules of examples 1 to 5, the capsules of comparative examples 1 to 4, three times a day, 1 granule each time; the results of statistically evaluating the therapeutic effects after 15 days of administration according to the conventional work and rest diet of the subjects are shown in the following table 3.
Table 3 treatment evaluation results
| Sample preparation | The number of people to be cured (no ulcer symptoms such as gastrectasia, gastralgia, belch, acid regurgitation, nausea and vomiting) | Repeated ulcer of rehabilitation person within 6 months after stopping taking medicine | Side effects (abdominal pain, nausea, rash, etc.) |
| Example 1 Capsule | 10 Patients healed | No repetition | Without any means for |
| Example 2 Capsule | 10 Patients healed | No repetition | Without any means for |
| Example 3 Capsule | 10 Patients healed | No repetition | Without any means for |
| Example 4 Capsule | 10 Patients healed | No repetition | Without any means for |
| Example 5 Capsule | 10 Patients healed | No repetition | Without any means for |
| Comparative example 1 Capsule | 8 Patients were cured | 2 People have recurrent ulcers | Without any means for |
| Comparative example 2 Capsule | 9 Patients were cured | 2 People have recurrent ulcers | Without any means for |
| Comparative example 3 Capsule | 6 Patients are healed | 4 People have recurrent ulcers | Without any means for |
| Comparative example 4 Capsule | 9 Patients were cured | No repetition | Without any means for |
From the above results, the pharmaceutical compositions of examples 1 to 5 have good gastric mucosa repair effect, can improve barrier protection ability of gastric mucosa, greatly reduce repeated diseases, and are safe without side effects.
Claims (10)
1. The pharmaceutical composition for treating the peptic gastric ulcer is characterized by being prepared from the following raw materials in parts by weight: 1 to 3 parts of a common rue herb extract, 1 to 3 parts of a white jade snail extract, 0.2 to 0.5 part of camellia seed oil, 0.5 to 1.5 parts of an eichhornia crassipes extract, 0.5 to 1.5 parts of a long pepper cubeba extract, 0.3 to 1 part of sodium bicarbonate and 0.5 to 1.5 parts of magnesium oxide;
the Pheretima extract is an enzymolysis product of Pheretima sequentially subjected to pepsin and trypsin; the white jade snail extract is an enzymolysis product of white jade snail mucus by pepsin.
2. The pharmaceutical composition for treating peptic ulcer according to claim 1, wherein said extract of koji is prepared by the following steps: cleaning and crushing the starter, crushing into slurry, adding water 3-5 times the mass of the slurry, uniformly mixing, adding hydrochloric acid to adjust the pH value to 1.5-2, adding pepsin, carrying out enzymolysis for 1-1.5 hours at 37-40 ℃, heating in water bath to deactivate enzyme, reducing the temperature to 36-38 ℃, adding sodium hydroxide to adjust the pH value to 7.5-8.0, adding trypsin, carrying out enzymolysis for 1-2 hours, heating in water bath to deactivate enzyme, reducing the temperature to room temperature, adopting a30 kDa ultrafiltration membrane to filter, collecting liquid with the pH value less than 30kDa, and freeze-drying to obtain the starter extract.
3. The pharmaceutical composition for treating peptic ulcer according to claim 2, wherein the amount of pepsin added is 1% to 5% of the mass of the slurry; the adding amount of the trypsin is 1% -5% of the mass of the slurry; the temperature of the water bath for heating and inactivating enzyme is above 90 ℃ for 15-30 min.
4. The therapeutic pharmaceutical composition for peptic ulcer according to claim 1, wherein said white jade snail extract is prepared by the following method: removing shells of white jade snails to obtain white jade snail bodies, repeatedly cleaning the white jade snail bodies with water 3-5 times of the white jade snail bodies until mucus of the white jade snail bodies is eluted to obtain mucus, washing and dehydrating, adding hydrochloric acid into the mucus eluting water to adjust the pH value to 1.5-2, then adding pepsin, carrying out enzymolysis for 1-1.5 hours at 37-40 ℃, heating in water bath to inactivate enzymes, cooling to room temperature, concentrating, and freeze-drying to obtain snail extracts.
5. The pharmaceutical composition for treating peptic ulcer according to claim 4, wherein the amount of pepsin added is 1% to 3% of the mass of the mucinous eluent; the temperature of the water bath for heating and inactivating enzyme is above 90 ℃ for 15-30 min.
6. The pharmaceutical composition for treating peptic ulcer according to claim 1, wherein said preparation method of the eichhornia crassipes extract comprises: crushing the eichhornia crassipes, adding water with the mass of 4-6 times of the eichhornia crassipes, regulating the pH value to 4.8-5.2, adding hemicellulase, carrying out enzymolysis for 1-2 hours at 50-60 ℃, heating in water bath to deactivate enzyme, reducing the temperature to 40-45 ℃, regulating the pH value to 6.5-7.2, adding bromelain and salivary amylase, carrying out enzymolysis for 1-2 hours, heating in water bath to deactivate enzyme, reducing the temperature to room temperature, filtering by adopting a 5kDa ultrafiltration membrane, collecting liquid with the concentration of below 5kDa, concentrating, and freeze-drying to obtain the eichhornia crassipes extract.
7. The pharmaceutical composition for treating peptic ulcer according to claim 6, wherein the amount of hemicellulase added is 0.5% to 2% of the mass of eichhornia crassipes; the addition amount of the bromelain and the salivary amylase is 0.5-2% of the mass of the eichhornia crassipes; the temperature of the water bath for heating and inactivating enzyme is above 90 ℃ for 15-30 min.
8. The pharmaceutical composition for treating peptic gastric ulcer according to claim 1, wherein the preparation method of the fructus Litseae extract comprises the following steps: pulverizing fructus Litseae, adding water 5-8 times of fructus Litseae, mixing, adding hydrochloric acid to adjust pH to 1.5-2, adding pepsin, performing enzymolysis at 37-40deg.C for 1-2 hr, heating in water bath to deactivate enzyme, cooling to room temperature, adding absolute ethanol, stirring, mixing, soaking, filtering with 500 mesh sieve, collecting filtrate, concentrating, and freeze drying to obtain fructus Litseae extract.
9. The pharmaceutical composition for treating peptic ulcer according to claim 8, wherein the amount of pepsin added is 1% to 3% of the mass of fructus Litseae; the temperature of the water bath for heating and inactivating enzyme is above 90 ℃ for 15-30 min; the addition amount of the absolute ethyl alcohol is 2-4 times of the mass of the fructus cubeba, and the stirring, mixing and soaking time is 1-2 hours.
10. A method of preparing a therapeutic pharmaceutical composition for peptic gastric ulcer according to claim 1, comprising the steps of:
S1: 1 to 3 parts of a curved-spike-shaped extractive, 1 to 3 parts of a white jade snail extractive, 0.2 to 0.5 part of camellia seed oil, 0.5 to 1.5 parts of an eichhornia crassipes extractive, 0.5 to 1.5 parts of a fructus piperis cubeba extractive, 0.3 to 1 part of sodium bicarbonate and 0.5 to 1.5 parts of magnesium oxide; firstly, uniformly mixing sodium bicarbonate and magnesium oxide, then sequentially adding an eichhornia crassipes extract and a fructus cubeba extract for uniform mixing, and finally, adding a field-roller extract, a snail extract and camellia seed oil for uniform mixing to obtain a pharmaceutical composition;
s2: the medicine composition is compounded with pharmaceutically acceptable auxiliary materials to prepare gastric-soluble tablets, gastric-soluble capsules or oral granules.
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