CN1243004A - Enterogastric medicine for resisting activity of pyloric twining bacillus - Google Patents
Enterogastric medicine for resisting activity of pyloric twining bacillus Download PDFInfo
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- CN1243004A CN1243004A CN 99110907 CN99110907A CN1243004A CN 1243004 A CN1243004 A CN 1243004A CN 99110907 CN99110907 CN 99110907 CN 99110907 A CN99110907 A CN 99110907A CN 1243004 A CN1243004 A CN 1243004A
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Abstract
To obtain a gastrointestinal drug which contains the combination of Coptidis rhizoma and/or Pbellodendri cortex puverata and Aurantii nobilis pericarpium pulveratum, possesses anti-Helicobacter pylori activity and is useful in the prevention, the treatment or the recidivation prevention for gastritis, gastric ulcer, duodental ulcer or the like. This gastrointestinal drug is obtained by including the combination of (A) Coptidis rhizoma and/or Phellodendri cortex pulverata or extracts and (B) Aurantii nobilis pericarpium pulveratum or extract. On this gastrointestinal drug, it is favorable to use 2-200 pts.wt. of the raw crude drug of the component B based on 1 pt.wt. of the raw crude drug of the component A. Further, it is favorable that this gastrointestinal drug includes at least one kind of histamine H2 receptor antagonist (e.g. cimetidine or the like), proton pump inhibitor (e.g. lansoprazole or the like), gastric mucosa protection type gastritis-peptic ulcer therapeutic drug (e.g. aldioxa or the like), antacid and stegnotic. On the amounts of the components A and B used, Coptidis rhizoma and Phellodendri cortex or Aurantii nobilis pericarpium are preferably used at daily doses of 0.03-6 g and 0.03-10 g, respectively, per an adult based on the raw crude drugs.
Description
The invention relates to the herbal powder of Rhizoma Coptidis and/or Cortex Phellodendri or extract the herbal powder of composition and Pericarpium Citri Reticulatae or be extracted into branch and make up the medicine for enterogastritis that forms.Medicine for enterogastritis of the present invention has anti-Helicobacter pylori activity, can be used for prevention and treatment gastritis, gastric ulcer, duodenal ulcer etc. or be used to prevent these palindromias.
Past people is known, the medical herbs of some kind demonstrates antibacterial action for Helicobacter pylori, for example, disclose among the Te Kaiping 8-295632 contain Rhizoma Coptidis etc. more than a kind herbal powder or extract the Helicobacter pylori antimicrobial drug of composition, in addition, disclose a kind of pharmaceutical composition among the Te Kaiping 10-109942, contained (a) and have the active herbal powder of anti-Helicobacter pylori or its and extract composition and (b) histamine H
2Receptor antagonist, proton pump inhibitor, at least a in the agent of gastric mucosal defense type gastritis treatment of peptic ulcer, antacid and the diarrhea, described medical herbs is a Rhizoma Coptidis.In addition, the 47th Japanese Japan medical science academic always give a lecture to have put down in writing in the main idea collection, in May, 1996, the 78th page, right hurdle use PPI or H in the ulcer case
2Blocker, a kind in the administration herbal mediciment is a Pingwei San then.
As the Therapeutic Method of killing Helicobacter pylori, be mostly in the past with penicillium sp prime system, cephalosporin system, Fourth Ring prime system, Novel Quinolone (ニ ェ one キ ノ ロ Application) be, antibiotic more than a kind and three doses of bismuth preparation, proton pump inhibitors (PPI) etc. in the macrolide etc. and use, though antibiotic bacteria-eliminating efficacy is very strong, cause side effect such as anaphylaxis or diarrhoea and the problem that fungus resistance occurs easily.
Therefore, urgent wish development a kind of effectively prevent or treat by Helicobacter pylori infect and intestinal medicine for treating gastrosis such as the gastritis that causes, gastric ulcer, duodenal ulcer, and contain that to have stronger anti-Helicobacter pylori active and to the medicine for enterogastritis of human body herb ingredients as safe as a house.
In order to solve above-mentioned problem, the inventor furthers investigate, found that, specific medical herbs combined to bring into play the active collaborative facilitation that suppresses Helicobacter pylori propagation, and then find, to think in the past and not have Helicobacter pylori antibacterial activity or the very weak histamine H2-receptor antagonist of antibacterial activity, perhaps proton pump inhibitor (lansoprazole for example, the La Beila azoles, omeprazole etc.), gastric mucosal defense type gastritis drug for peptic ulcer, bismuth preparation and treat normally used antacid of gastritis etc. clinically and combine, can obtain especially significant gastritis, the prevention of gastric ulcer and duodenal ulcer etc., the treatment and prevent to recur effect, thereby finished the present invention.
That is, the invention relates to:
(1) will be 1. Rhizoma Coptidis and/or Cortex Phellodendri herbal powder extract the herbal powder of composition and 2. Pericarpium Citri Reticulatae or be extracted into the branch combination and constitute have an active medicine for enterogastritis of anti-Helicobacter pylori.
(2) medicine for enterogastritis described in above-mentioned (1), wherein, with respect to the herbal powder of the 1. Rhizoma Coptidis of the former medical herbs of 1 part of weight or extract medical herbs end or the extraction composition that composition uses the 2. Pericarpium Citri Reticulatae of the former medical herbs of about 2-200 part weight.
(3) medicine for enterogastritis described in above-mentioned (1), wherein, with respect to the medical herbs powder of the 1. Cortex Phellodendri of the former medical herbs of 1 part of weight or extract medical herbs powder or the extraction composition that composition uses the 2. Pericarpium Citri Reticulatae of the former medical herbs of about 1-100 part weight.
(4) medicine for enterogastritis described in above-mentioned (1) wherein, with respect to the medical herbs powder of the 1. Rhizoma Coptidis of the former medical herbs of 1 part of weight and Cortex Phellodendri or extract composition, uses the medical herbs powder or the extraction composition of the 2. Pericarpium Citri Reticulatae of the about 1-200 part of former medical herbs weight.
(5) medicine for enterogastritis described in above-mentioned (1) of the gastroenteropathy cause because of Helicobacter pylori infects of prevention or treatment.
(6) medicine for enterogastritis described in above-mentioned (1) wherein, contains histamine H
2At least a in receptor antagonist, proton pump inhibitor, gastric mucosal defense type gastritis drug for peptic ulcer, antacid and the diarrhea.
(7) medicine for enterogastritis described in above-mentioned (1) wherein, contains histamine H
2Receptor antagonist.
(8) medicine for enterogastritis described in above-mentioned (7), wherein, histamine H
2Receptor antagonist is cimetidine or its salt that pharmaceutically allows.
(9) medicine for enterogastritis described in above-mentioned (1) wherein, contains antacid.
(10) as herb ingredients, by the medical herbs powder of (1) Rhizoma Coptidis and/or Cortex Phellodendri or extract the medical herbs powder of composition and (2) Pericarpium Citri Reticulatae or be extracted into the medicine for enterogastritis that branch constitutes.
(11) medicine for enterogastritis described in above-mentioned (10) wherein, contains histamine H
2At least a in receptor antagonist, proton pump inhibitor, gastric mucosal defense type gastritis drug for peptic ulcer, antacid and the diarrhea.
(12) by the medical herbs powder of Rhizoma Coptidis, Cortex Phellodendri and Pericarpium Citri Reticulatae or extract that composition constitutes have an active medicine for enterogastritis of anti-Helicobacter pylori.
(13) the medical herbs powder of Pericarpium Citri Reticulatae or extraction composition are in the active using method of anti-Helicobacter pylori that strengthens Rhizoma Coptidis and/or Cortex Phellodendri.
The present invention is a kind of medicine for enterogastritis, it is characterized in that: the medical herbs powder of (1) Rhizoma Coptidis or extract composition and the medical herbs powder of Pericarpium Citri Reticulatae or to be extracted into branch combined, (2) the medical herbs powder of Cortex Phellodendri or extract composition and the medical herbs powder of Pericarpium Citri Reticulatae or to be extracted into branch combined, perhaps, the medical herbs powder of (3) Rhizoma Coptidis and Cortex Phellodendri or extract composition and the medical herbs powder of Pericarpium Citri Reticulatae or to be extracted into branch combined.Particularly preferably be the medical herbs powder of Rhizoma Coptidis or extract composition and the medical herbs powder of Pericarpium Citri Reticulatae or to be extracted into branch combined.These medical herbs powder or extraction composition can be used as independent preparation and merge use, also can make mixture and use.
Medical herbs powder of above-mentioned (1) Rhizoma Coptidis and/or Cortex Phellodendri or extraction composition can suitably be selected with the medical herbs powder of (2) Pericarpium Citri Reticulatae or the combination matching of extraction composition, but, with take easily and low-cost Pericarpium Citri Reticulatae is compared, Rhizoma Coptidis and Cortex Phellodendri taste are very bitter and price is very high, therefore, in medicine for enterogastritis of the present invention,, can reduce the dosage of Rhizoma Coptidis and Cortex Phellodendri relatively according to the synergism that particular combinations produced (experimental example in vide infra) of herb ingredients.In view of this consideration, when considering the proportioning of above-mentioned medical herbs, with respect to the medical herbs powder of the Rhizoma Coptidis of 1 part of weight of former medical herbs or extract composition, Pericarpium Citri Reticulatae is converted into former medical herbs and is about 2-200 part weight, preferably about 5-100 part weight, preferably about 10-50 part weight.In addition, with respect to the medical herbs powder or the extraction composition of 1 part of weight of the former medical herbs of Cortex Phellodendri, Pericarpium Citri Reticulatae is converted into former medical herbs and is about 1-100 part weight, preferably about 2-50 part weight, preferably about 3-30 part weight.With respect to the Rhizoma Coptidis of 1 part of weight of former medical herbs and medical herbs powder or the extraction composition of Cortex Phellodendri, Pericarpium Citri Reticulatae is converted into former medical herbs and is about l-200 part weight, preferably about 5-100 part weight, preferably about 10-50 part weight.In addition, the ratio that cooperates of Rhizoma Coptidis at this moment and Cortex Phellodendri, with respect to the medical herbs powder of the Rhizoma Coptidis of 1 part of weight of former medical herbs or extract composition, it is 0.2-30 part weight that Cortex Phellodendri is converted into former medical herbs, preferably about 0.5-10 part weight, preferably about 1-3 part weight.
Medicine for enterogastritis of the present invention preferably also contains histamine H
2At least a in receptor antagonist, proton pump inhibitor, gastric mucosal defense type gastritis drug for peptic ulcer, antacid and the diarrhea.
Histamine H
2Receptor antagonist for example can be enumerated cimetidine, ranitidine, famotidine, roxatidine, nizatidine and their salt or the derivant that pharmaceutically allow, can select use more than a kind wherein.Described salt or the derivant that pharmaceutically allows, for example, the salt of ranitidine can be enumerated the hydrochloric acid ranitidine, and the derivant of roxatidine can be enumerated the hydrochloric acid roxatidine acetate.
Proton pump inhibitor for example can be enumerated
Rope draws azoles, omeprazole, Pan Tela azoles (バ Application ト Block ラ ソ-Le), La Beila azoles, Le Minuola azoles (レ ミ ノ Block ラ ソ-Le) etc. and their salt that pharmaceutically allows, can therefrom select to use more than a kind, preferentially select lansoprazole, omeprazole or La Beila azoles for use.Proton pump inhibitor preferably with antacid described below and usefulness, perhaps make enteric solubility preparation or stabilized preparations (for example alkaline, inorganic salts of magnesium or calcium), be used for the influence of gastric acid inhibitory.
The curative of above-mentioned gastric mucosal defense type gastritis peptic ulcer for example can be enumerated, aldioxa, aldioxa silicic acid magnesium aluminate, sucralfate, proglumide, teprenone, cetraxate hydrochloride, plaunotol, sofalcone, hydrochloric acid benexate-β this gram of its dawn ( デ ス Network), maleic acid clothing Suo Gelaxin (ィ Le ソ ゲ ラ ジ Application), Lei Bapi miaow spy (レ バ ピ ミ De), Ai Jiabeituo sodium (エ カ ベ ト Na ト リ ゥ system), Bo Lapuxinke (Port ラ プ ジ Application Network) etc., can therefrom select to use more than a kind, wherein preferentially select sucralfate for use, cetraxate hydrochloride, teprenone or sofalcone.
Above-mentioned antacid for example can be enumerated Aluminium Hydroxide, the silicic acid magnesium aluminate, magnesium silicate, synthetic aluminium silicate, synthetic hydrotalcite, magnesium oxide, aluminum magnesium hydroxide, gel aluminum hydroxide, aluminium hydroxide, sodium bicarbonate co-precipitation product, aluminium hydroxide magnesium carbonate combination drying gel, aluminium hydroxide magnesium carbonate calcium carbonate co-precipitation product, magnesium hydroxide, sodium bicarbonate, magnesium carbonate, winnofil, aluminosilicate magnesium, calcium phosphate dibasic anhydrous, inorganic antacid such as calcium hydrogen phosphate; Amino acid preparations such as glycine; Dihydroxyaluminum aminoacetate; Rhizoma Scopoliae Japonicae extractum etc.Can therefrom select to use more than a kind.
Above-mentioned diarrhea for example can be enumerated bismuth preparation (for example bismuth subsalicylate, bismuth subnitrate, bismuth subcarbonate, inferior no food give sour bismuth etc.), tannin preparation (for example tannin, albumin tannate, methylene thymol tannin etc.), can therefrom select to use more than a kind, wherein preferentially select for use for the effective especially bismuth preparation of Helicobacter pylori.
In medicine for enterogastritis of the present invention, for example can add as required and be selected from following at least a medical herbs powder or its extraction composition: Semen Arecae (Areca), Pericarpium Granati (Punica granatum), Radix Glycyrrhizae (Lic oriceroot), Rhizoma Cimicifugae (Cimicifuga rhizome), Herba Artemisiae Scopariae (Artemisiae capillaris herba), Rhizoma Corydalis (Corydalis tuber), Folium Sennae (Senna), Folium Perillae (perilla herb), Fructus Arctii (Actiumlappa), Radix Salviae Miltiorrhizae (Salviae miltiorrhizae), Hindu lotus petiole (Forsythiae fructus), Cortex Moutan (Moutancortex), Fructus Crataegi (Crataegus), Aconitum carmichjaelii Debx. (Aconitum carmichaeli), Flos Lonicerae (Radix Ophiopogonis, Louicwra japonica), Rhizoma Cyperi (Cyperus rhizome), Flos Carthami (Carthami flos), the Radix Linderae (Linderastrychnifolia), Semen Nelumbinis (Lotus seed), Radix Et Rhizoma Rhei (Rhubarb), Rhizoma Zingiberis Recens (Ginger), Radix Sophorae Flavescentis (Sophoraroot), Aloe (Aloe), Radix Paeoniae (Peony root), Flos Caryophylli (Clove), Radix Scutellariae (Scutellaria root), Fructus Aurantii Immaturus (Immature orange), Cortex Magnoliae Officinalis (Magnolia bark) is preferably added Rhizoma Zingiberis Recens, Radix Scutellariae, Fructus Aurantii Immaturus, Flos Caryophylli, Radix Glycyrrhizae, the medical herbs powder of Cortex Magnoliae Officinalis or Rhizoma Corydalis or its extract a kind in the composition.
The medical herbs powder that uses among the present invention and extract composition is the medical herbs powder that uses as single medicinal material or medium-height grass prescription since ancient times and extract composition, can directly use the medical herbs powder that obtains by conventional process or extract composition.Medical herbs powder or extraction composition can use commercially available product or its processed goods.The medical herbs powder for example also can use the further fine powder of exsiccant silk processed goods broken and obtain the dry product (medical herbs xeraphium) of Powdered or micronized.In addition, the form of the extraction composition of medical herbs has no particular limits, and for example can use dry extract, extract powder, pilular extract, fluid extract, contain any forms such as tincture of ethanol or second alcohol and water.Preferentially select the high extraction composition of freedom of preparationization for use, for example dry extract.
Extract composition and can adopt customary way to obtain, for example from medical herbs of the present invention, extract active component with anti-Helicobacter pylori effect with extraction solvent.Extraction solvent for example can make water, hydrophilic solvent or their mixture.Above-mentioned hydrophilic solvent for example can be enumerated alcohols such as methanol, ethanol, propanol, isopropyl alcohol, butanols, isobutanol, sec-butyl alcohol, the tert-butyl alcohol (the preferably water-soluble alcohol, particularly ethanol of 1-3 carbon atoms such as methanol, ethanol, propanol, isopropyl alcohol); Cellosolve such as methyl cellosolve, ethyl cellosolve class; Ketones such as acetone; Ethers such as diox, oxolane; Pyridine, morpholine, acetonitrile, N, nitrogenous solvents such as dinethylformamide, dimethyl acetylamide, N-Methyl pyrrolidone.These hydrophilic solvents can use separately, also can use the mixed solvent more than 2 kinds.Have the active composition of anti-Helicobacter pylori in order more effectively to extract, the mixed solution that preferably uses above-mentioned alcohols or above-mentioned alcohols and water is as extraction solvent.
When above-mentioned extraction solvent makes the mixed solvent of water and hydrophilic solvent, the match ratio of water and hydrophilic solvent for example can be about 5/95 (weight ratio) of water/hydrophilic solvent=about 95/5-, preferably about 50/50 (weight ratio) of water/hydrophilic solvent=about 90/10-, preferably about 60/40 (weight ratio) of water/hydrophilic solvent=about 85/15-.Extract operation and can under suitable temperature, carry out the reflux temperature of for example about 10 ℃～solvent, preferably about 15-70 ℃ temperature.In addition, also merceration extraction at room temperature.The extracting solution that extracts with extraction solvent can directly be used as the extraction composition, also can water etc. dilutes, and perhaps also the extractum that extracts can be concentrated the back and use concentrated extract.Usually, can add additive as required in concentrated extract that obtains in that extracting solution is concentrated or the extract, make powder with methods such as spray drying, lyophilizations under the situation mostly, use resulting extract powder.
The consumption of the medical herbs powder of the Rhizoma Coptidis in the medicine for enterogastritis of the present invention, Cortex Phellodendri and Pericarpium Citri Reticulatae or extraction composition, so long as the effective dose that demonstrates antibacterial activity for Helicobacter pylori gets final product, have no particular limits, in the occasion of giving people's medication, according to dosage form, route of administration, consumptions such as treatment target, symptom degree and kind are different, for example, the adult calculates the about 0.01-10g of Rhizoma Coptidis, preferably about 0.03-6g (body weight 60kg) every day with former medical herbs, the about 0.01-20g of Cortex Phellodendri, preferably about 0.03-10g, the about 0.01-50g of Pericarpium Citri Reticulatae, preferably about 0.03-10g.Administration number of times has no particular limits, can every day 1 time or divide administration several times every day.
Histamine H
2Receptor antagonist uses wantonly a kind in cimetidine, ranitidine, famotidine, roxatidine, the nizatidine etc. usually.These histamine H
2The consumption of receptor antagonist can suitably be selected to determine by the medical worker.Employed amount ranges in the time of can using general therapeutic (for example, adult (60kg) every day about 1-800mg).For example, the consumption of being grown up (60kg) every day is the about 10-800mg of cimetidine, ranitidine adopts the about 5-300mg of hydrochloric acid ranitidine, the about 1-40mg of famotidine, roxatidine adopts the about 5-150mg of hydrochloric acid roxatidine acetate, the preferably about 30-300mg of nizatidine.
In addition, its administration number of times and usage can suitably be determined.
The dosage of proton pump inhibitor can be used the employed amount ranges of general therapeutic, and about 0.01-100mg (60kg) every day for example is grown up.Concrete consumption can suitably be selected by the medical worker, determine.For example, adult's (60kg) consumption every day, the about 0.01-30mg of lansoprazole, the about 0.01-20mg of omeprazole.
Administration number of times can also can divide 2-3 administration with the dosage of every day once a day, and according to gastric ulcer treatment standard, the administration persistent period should be no more than for 8 weeks, and according to duodenal ulcer treatment standard, the administration persistent period was no more than for 6 weeks.These proton pump inhibitors, with with the medical herbs powder of (1) Rhizoma Coptidis and/or Cortex Phellodendri or extract the medical herbs powder of composition and (2) Pericarpium Citri Reticulatae or be extracted into the herb ingredients combination that the branch combination forms and use, can treat the intestinal medicine for treating gastrosis that causes because of Helicobacter pylori more effective, quickly or prevent these palindromia, its effect is according to dosage form, route of administration, treatment target, symptom degree and kind and different, in general, 8 weeks of medication effect of sufficient can be obtained during the treatment gastric ulcer, 6 weeks of medication effect of sufficient can be obtained during the treatment duodenal ulcer.
The curative of gastric mucosal defense type gastritis peptic ulcer can suitably be selected definite by the medical worker according to the consumption of general use (for example, adult's (60kg) every day about 0.01-3600mg).Its administration number of times can be definite according to imposing a condition in the medical treatment, preferably takes into account other composition of cooperation, every day 1 time or divide 2-4 administration.
Antacid can adopt normally used amount ranges, and these antacid can be used in combination more than a kind.For example, inorganic antacid maximum consumption every day is about 1-30g, and every day, minimum amount was 1/100 of a maximum consumption, promptly about 0.01-0.3g.To the about 0.01-2g of consumption every day of glycine of adult's (60kg) amino acid preparation, to the about 0.1-10g of consumption every day of the dihydroxyaluminum aminoacetate of be grown up (60kg).Consumption every day of Rhizoma Scopoliae Japonicae extractum to adult (60kg) is about 0.1-100mg.Concrete consumption can suitably be selected by the medical worker, determine.
Diarrhea can adopt the amount ranges of general use, for example, and to the about 0.01-10g of consumption every day of adult's (60kg) bismuth preparation, the adult's of tannin preparation (60kg) the about 0.01-10g of consumption every day.Concrete consumption can suitably be selected by the medical worker, determine.
Except these histamine H
2Outside receptor antagonist, proton pump inhibitor, gastric mucosal defense type gastritis drug for peptic ulcer, antacid, the diarrhea composition, can also and with or cooperate other composition of allocating into usually in the medicine for enterogastritis, for example digest the agent of medicinal physiotherapy intestinal, analgesia anti-spasmodics, mucosa and repair medicine, defoamer dimethyl polysiloxane isoreactivity composition.
Normally oral medicine of medicine for enterogastritis of the present invention.The kind of the oral medicine preparation of this medicine for enterogastritis has no particular limits, and for example can be solid preparations such as tablet, granule, granula subtilis, pill, capsule, chewable tablet, also can be liquors such as syrup, suspending agent, Emulsion.
When making preparation, can use habitual carrier components according to the kind of preparation, for example, the habitual composition when making solid preparation can use saccharides such as starch, lactose, sucrose, mannitol, corn starch; Excipient such as crystalline cellulose, carboxymethyl cellulose, light anhydrous silicic acid; Binding agents such as polyvinyl alcohol, polyvinylpyrrolidone, polyvinylether, ethyl cellulose, Radix Acaciae senegalis, tragcanth, gelatin, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, calcium citrate, dextrin, pectin; Lubricants such as magnesium stearate, calcium stearate, Talcum, Polyethylene Glycol, colloidal silica; Starch, carboxymethyl cellulose, carboxymethylcellulose calcium, staggered carmellose sodium disintegrating agents such as (Network ロ ス カ Le メ ロ ス Na ト リ ゥ system), disintegrate auxiliary agent, wetting agent or surfactant etc.
In addition,, reach the purpose of enteric solubility or persistence, can carry out coating, make the oral medicine preparation with known method in order to shelter abnormal flavour.Described coating materials for example can use hydroxypropyl emthylcellulose, ethyl cellulose, hydroxy methocel, hydroxypropyl cellulose, polyoxyethylene glycol, soil temperature 80, Pu Luluonike (Pluronic) F68, Cellacefate, hydroxypropylmethyl cellulose phthalate, acetic acid methylol methyl cellulose succinate acid esters, ォ ィ De ラ ギ ッ De (German ロ-system company manufacturing, methacrylic acid acrylic copolymer) and pigments such as titanium dioxide, ferrum oxide.Preferably adopt the method described in the special fair 3-38247 to make the oral medicine preparation.
When making liquor, can use habitual composition, for example water (comprising water for injection), ethanol, ethylene glycol equal solvent; Cosolvents such as ethanol, Polyethylene Glycol, propylene glycol, D-mannitol, cholesterol, triethanolamine, sodium carbonate, sodium citrate; Surfactants such as octadecyl triethanolamine, sodium lauryl sulphate, lecithin, glyceryl monostearate; Hydrophilic macromolecule suspending agents such as polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, hydroxy methocel, hydroxyethyl-cellulose, hydroxypropyl cellulose; Phosphate, acetate, carbonate; Buffer agents such as citrate; Glucose, aminoacid etc.
In above-mentioned solid preparation and liquor, can use preservative agent, solubilizing agent, emulsifying agent, dispersant, thickening agent, plasticizer, adsorbent, spice, coloring agent, drug flavoring, sweeting agent, antiseptic, antioxidant etc. as required.
Medicine for enterogastritis of the present invention can be according to the kind of preparation, for example adopts and mixes, customary way manufacturings such as mixing, pelletize, tabletting, coating, sterilization treatment, emulsifying.In addition, about the manufacturing of preparation, can be according to the every regulation manufacturing in the Pharmacopeia of Japan preparation general provisions.
Medicine for enterogastritis of the present invention uses and is used for medicinal herb ingredients since ancient times as main component, thereby does not have toxic side effects, can give the mammal medication that comprises the people, and is fool proof.
The various gastroenteropathys, particularly gastritis that medicine for enterogastritis of the present invention can be used for the treatment of and prevent to be caused by Helicobacter pylori effectively, gastric ulcer, duodenal ulcer etc. also can be used for treatment and prevention gastric cancer in some occasion.
Medicine for enterogastritis of the present invention, not only can use the medical herbs powder of (1) Rhizoma Coptidis and/or Cortex Phellodendri or extract composition and the medical herbs powder of (2) Pericarpium Citri Reticulatae or the mixture of extraction composition, also each effective ingredient can be made preparation respectively, while or interval certain hour are given same patient's medication.In addition, for can or being extracted into the histamine H that the branch combination is used with these medical herbs powder
2It is at least a that medical herbs powder beyond curative, antacid, diarrhea, above-mentioned Rhizoma Coptidis, Cortex Phellodendri and the Pericarpium Citri Reticulatae of receptor antagonist, proton pump inhibitor, gastric mucosal defense type gastritis peptic ulcer or be extracted into grades, not only can use mixture, also each effective ingredient can be made preparation respectively, while or interval certain hour are given same patient's medication.
The working of an invention scheme
Explain the present invention below by embodiment, but the present invention is not subjected to the restriction of these embodiment.
[embodiment]
Reference example
The manufacturing of dry extract
In 50g Rhizoma Coptidis silk, add 30 capacity % ethanol waters of about 7 times of amounts (being 350ml), with the rotating speed stirring of 30rpm, 50 ℃ of following extractings 1.5 hours.Filter with standard screen (nominal dimension 75 μ m), residue washs with 30 capacity % ethanol water 150ml.Merge the filtrate and the cleaning mixture that reclaim, carry out suction strainer.The filtrate of reclaiming is evaporated to below the temperature about 50ml at 50 ℃, obtains pilular extract.With this pilular extract lyophilization 24 hours, obtain dry extract.Equally, make dry extract by Cortex Phellodendri and Pericarpium Citri Reticulatae.
The test example
The propagation inhibition test of Helicobacter pylori
Use the dry extract of the Rhizoma Coptidis, Cortex Phellodendri and the Pericarpium Citri Reticulatae that obtain in the reference example, and the employing agar plate dilutes the check-out console method and measures the anti-Helicobacter pylori activity that mentioned component produces.Dry extract is dissolved in the sterile purified water 2 times of preparation series of reuse sterile purified water dilution.The sample survey 2ml of also each dilution series combination of the extractum of usefulness is mixed with cloth Lu Shi agar (Brucella agar) the culture medium l8ml that adds 7% horse serum, make and measure with flat board.As being verified bacterium, the NCTC11916 of CPY433, the TN2 of use (a) clinical separation strain, TN58, the strain of (b) metronidazole patience.CPY433 and NCTC11916 are on the books in document (European Journal of Clinical Microbiologyand Infectious Diseases, 14,391-399, (1995)).In addition, TN2 can be respectively obtains by the strain that is provided by big minute medical university is provided as 91-196 as 92-244, TN58.Use cloth Lu Shi meat soup (Brucella broth) culture medium of adding 2.5% fetal bovine serum, inserting CampyPak
TMIn the thermos flask of (BBL Beckton Dickinson Microbiology System), under 37 ℃ with these experimental bacteria shaken cultivation 20 hours.To adjust concentration on this culture medium is about 10
6Each bacterium liquid 5 μ l of CFU (colony-forming units)/ml are inoculated into each and measure with on the agar plate, contain CampyPak in insertion
TMWith in the thermos flask of the absorbent cotton of water, cultivated 4 days down in 37 ℃.After the cultivation, the developmental state of perusal bacterium will be tested the MIC (the minimum growth stops concentration) of extractum with the least concentration of not observing growth as this.Obtain the two extractum FIC (fractional inhiditory concentration) separately of the combined concentration of strong interaction, the FIC sum that calculates two extractum is FIC index.FIC index is at document (Krogstad Dj, Mollering RC:Antimicrobialcombinations.In:Lorian V (ed): Antibiotics in laboratory medicine.Williams ﹠amp; Wilkins, Baltimore, 1986, P.537-595) the existing detailed description in detail in, according to the record in the document, FIC index has synergism when following 0.5, have summation action during＞0.5-10, do not interact during＞1.0-2.0 (not having influence) is greater than having antagonism at 2.0 o'clock.
Result of the test is shown in Table 1.Shown in the table 1 by each independent MIC and and with the FIC value obtained of MIC value of (combination) generation with and the FIC index that obtains thus.
The anti-Helicobacter pylori active bacterial strain FIC that table 1 herb extracts and time spent produce (
*And use MIC/
*Independent MIC) FIC index
CPY433 0.50 ( 62.5/125 ) 0.50 ( 125/250 ) 1.00TN2 0.50 ( 62.5/125 ) 0.50 ( 125/250 ) 1.00TN58 0.50 ( 62.5/125 ) 0.50 ( 125/250 ) 1.00NCTC11916 0.50 ( 62.5/125 ) 0.50 ( 125/250 ) 1.00 CPY433 0.13 ( 15.6/125 ) ≤0.25 ( 500/≥2000 ) ≤0.38TN2 0.13 ( 15.6/125 ) ≤0.25 ( 500/≥2000 ) ≤0.38TN58 0.13 ( 15.6/125 ) ≤0.25 ( 500/≥2000 ) ≤0.38NCTC11916 0.13 ( 15.6/125 ) ≤0.25 ( 500/≥2000 ) ≤0.38 CPY433 0.25 ( 62.5/250 ) ≤0.25 ( 500/≥2000 ) ≤0.50TN2 0.25 ( 62.5/250 ) ≤0.25 ( 500/≥2000 ) ≤0.50TN58 0.25 ( 62.5/250 ) ≤0.13 ( 250/≥2000 ) ≤0.38NCTC11916 0.25 ( 62.5/250 ) ≤0.25 ( 500/≥2000 ) ≤0.50*And with MIC and separately the unit of MIC be μ g/ml
The FIC index of Rhizoma Coptidis and Cortex Phellodendri and time spent is 1.00, demonstrate summation action, and FIC index≤0.38～≤ 0.50 of Rhizoma Coptidis or Cortex Phellodendri and Pericarpium Citri Reticulatae and time spent demonstrates synergism, particularly Rhizoma Coptidis and Pericarpium Citri Reticulatae and time spent, demonstrates tangible synergism.
Specifically, show separately respectively that with Rhizoma Coptidis and Cortex Phellodendri the active concentration of anti-Helicobacter pylori compares, by adding Pericarpium Citri Reticulatae, the activity of Rhizoma Coptidis increases 8 times, and the activity of Cortex Phellodendri increases 4 times.In addition, demonstrate the active concentration of anti-Helicobacter pylori separately with Pericarpium Citri Reticulatae and compare, by adding Rhizoma Coptidis or Cortex Phellodendri, its activity strengthens respectively more than 4 times.This shows that Rhizoma Coptidis or Cortex Phellodendri and Pericarpium Citri Reticulatae and time spent have the effect that significantly multiplies each other.
In addition, adopt method check Rhizoma Coptidis, Cortex Phellodendri and the effect of Pericarpium Citri Reticulatae and time spent same,, the MIC value when having only Rhizoma Coptidis and Cortex Phellodendri is reduced to below 1/4 by also using Pericarpium Citri Reticulatae with above-mentioned test.3 doses and time spent, Rhizoma Coptidis and Cortex Phellodendri significantly reduce for the MIC value of Helicobacter pylori, and hence one can see that, and Pericarpium Citri Reticulatae and Rhizoma Coptidis and Cortex Phellodendri also can significantly strengthen anti-Helicobacter pylori activity with Pericarpium Citri Reticulatae.
Specifically describe formulation example of the present invention below, but the present invention is not subjected to the restriction of these formulation example.In addition, in following example, if not otherwise specified, the use level of each composition is meant adult (60kg) dose of every day, makes preparation according to a conventional method.
Embodiment 1
(prescription) adult dose (in 3 bags) [mg] on the 1st
Rhizoma Coptidis dry extract 10
Pericarpium Citri tangerinae dry extrat 250
Cimetidine 300
Sucralfate 1500
Crystalline cellulose 1200
Starch 450
Hydroxypropyl cellulose 180
Lactose 520
Add up to 4410
Make mixed-powder by above-mentioned prescription, make granule according to the regulation of one of granule in the Pharmacopeia of Japan preparation general provisions.
Embodiment 2
(prescription) adult dose (in 3 bags) [mg] on the 1st
Cortex Phellodendri dry extract 50
Pericarpium Citri tangerinae dry extrat 500
Radix Scutellariae dry extract 450
Synthetic hydrotalcite 700
Magnesium oxide 800
Bismuth subgallate 1000
Crystalline cellulose 900
Starch 600
Hydroxypropyl cellulose 180
Lactose 690
Add up to 5870
By above-mentioned prescription, make granule according to the regulation of one of granule in the Pharmacopeia of Japan preparation general provisions.
Embodiment 3
[label]
(prescription) adult dose (in 9) [mg] on the 1st
Rhizoma Coptidis dry extract 10
Cortex Phellodendri dry extract 20
Pericarpium Citri tangerinae dry extrat 300
Rhizoma Zingiberis Recens dry extract 500
Cimetidine 300
Crystalline cellulose 444
Starch 295
Hydroxypropyl cellulose 103
Magnesium stearate 20
Lactose 700
Subtotal 2692
[coated tablet]
Label 2692
Sliding 1141.1
Radix Acaciae senegalis 75.3
Titanium oxide 46.3
White sugar 1104.3
Add up to 5059.0
By above-mentioned prescription, make label and coated tablet according to the regulation of one in tablet in the Pharmacopeia of Japan preparation general provisions.
Embodiment 4
(prescription) adult dose (among the 60ml) on the 1st
Rhizoma Coptidis dry extract 10mg
Cortex Phellodendri dry extract 30mg
Pericarpium Citri tangerinae dry extrat 600mg
Magnesium hydroxide 1000mg
Gel aluminum hydroxide 600mg
Cimetidine 240mg
Castor sugar 3000mg
Butyl p-hydroxybenzoate 7.5mg
Correctives 0.06ml
Distilled water (adding total amount to) 60ml
By above-mentioned prescription, make solution according to the regulation of one of solution in the Pharmacopeia of Japan preparation general provisions.Filter the back sterilization, in the vial of packing into then.
The effect of invention
Medicine for enterogastritis of the present invention demonstrates stronger antibacterial activity, and particularly anti-helicobacter pylori is lived The property, there are not the side effects such as the common allergy of antibiotic or diarrhoea, drug-fast bacteria can not appear, can use In medicine medicine for enterogastritis particularly, the gastritis that prevention or treatment are caused by helicobacter pylori, gastric ulcer or Gastrointestinal diseases such as duodenal ulcer or prevent these palindromia. In addition, can reduce each herbal medicine The usefulness of powder or extraction composition, particularly price height and the very big coptis root that is difficult to take of bitter taste and/or golden cypress Amount, thereby the preparation of taking easily can be provided, and economically also favourable.
Claims (13)
1. have the active medicine for enterogastritis of anti-Helicobacter pylori, it is characterized in that, by the herbal powder of 1. Rhizoma Coptidis and/or Cortex Phellodendri or extract composition and 2. Pericarpium Citri Reticulatae herbal powder or be extracted into branch and make up and constitute.
2. the described medicine for enterogastritis of claim 1 wherein, with respect to the medical herbs powder of the 1. Rhizoma Coptidis of 1 part of weight of former medical herbs or extract composition, uses the medical herbs end or the extraction composition of the 2. Pericarpium Citri Reticulatae of the about 2-200 part of former medical herbs weight.
3. the described medicine for enterogastritis of claim 1 wherein, with respect to the medical herbs powder of the 1. Cortex Phellodendri of 1 part of weight of former medical herbs or extract composition, uses the medical herbs powder or the extraction composition of the 2. Pericarpium Citri Reticulatae of the about 1-100 part of primary medical herbs weight.
4. the described medicine for enterogastritis of claim 1 wherein, with respect to the 1. Rhizoma Coptidis of 1 part of weight of former medical herbs and medical herbs powder or the extraction composition of Cortex Phellodendri, uses the medical herbs powder or the extraction composition of the 2. Pericarpium Citri Reticulatae of the about 1-200 part of former medical herbs weight.
5. the described medicine for enterogastritis of claim 1 is characterized in that, is the gastrointestinal disease that causes is infected in prevention or treatment because of Helicobacter pylori medicament.
6. the described medicine for enterogastritis of claim 1 wherein, contains histamine H
2At least a in receptor antagonist, proton pump inhibitor, gastric mucosal defense type gastritis drug for peptic ulcer, antacid and the diarrhea.
7. the described medicine for enterogastritis of claim 1 wherein, contains histamine H
2Receptor antagonist.
8. the described medicine for enterogastritis of claim 7, wherein, histamine H
2Receptor antagonist is cimetidine or its salt that pharmaceutically allows.
9. the described medicine for enterogastritis of claim 1 wherein, contains antacid.
One kind by the medical herbs powder of 1. Rhizoma Coptidis and/or Cortex Phellodendri or extract composition and 2. the medical herbs powder of Pericarpium Citri Reticulatae or extraction composition as medicine for enterogastritis that herb ingredients constituted.
11. the described medicine for enterogastritis of claim 10 wherein, contains histamine H
2At least a in receptor antagonist, proton pump inhibitor, the agent of gastric mucosal defense type gastritis treatment of peptic ulcer, antacid and the diarrhea.
12. by the medical herbs powder of Rhizoma Coptidis, Cortex Phellodendri and Pericarpium Citri Reticulatae or be extracted into that branch constitutes have an active medicine for enterogastritis of anti-Helicobacter pylori.
13. the medical herbs powder of Pericarpium Citri Reticulatae or extraction composition strengthen the active using method of anti-Helicobacter pylori of Rhizoma Coptidis and/or Cortex Phellodendri.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 99110907 CN1243004A (en) | 1998-06-11 | 1999-06-11 | Enterogastric medicine for resisting activity of pyloric twining bacillus |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP163811/1998 | 1998-06-11 | ||
| CN 99110907 CN1243004A (en) | 1998-06-11 | 1999-06-11 | Enterogastric medicine for resisting activity of pyloric twining bacillus |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1243004A true CN1243004A (en) | 2000-02-02 |
Family
ID=5274774
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 99110907 Pending CN1243004A (en) | 1998-06-11 | 1999-06-11 | Enterogastric medicine for resisting activity of pyloric twining bacillus |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1243004A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101632826B (en) * | 2009-07-16 | 2011-07-20 | 中国人民解放军海军医学研究所 | Traditional Chinese medicine composition for treating peptic ulcer and preparation method thereof |
| CN108653381A (en) * | 2018-07-11 | 2018-10-16 | 合肥华盖生物科技有限公司 | A kind of Chinese and western medicinal composition preparation method for treating chronic gastric ulcer |
-
1999
- 1999-06-11 CN CN 99110907 patent/CN1243004A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101632826B (en) * | 2009-07-16 | 2011-07-20 | 中国人民解放军海军医学研究所 | Traditional Chinese medicine composition for treating peptic ulcer and preparation method thereof |
| CN108653381A (en) * | 2018-07-11 | 2018-10-16 | 合肥华盖生物科技有限公司 | A kind of Chinese and western medicinal composition preparation method for treating chronic gastric ulcer |
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