CN105250944A - Capsules for treating peptic ulcers - Google Patents
Capsules for treating peptic ulcers Download PDFInfo
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Abstract
The invention discloses capsules for treating peptic ulcers. The capsules are prepared through the method that 100 parts of medicine granules and 1-5 parts of lubricant by weight are evenly mixed and then encapsulated, wherein the medicine granules are prepared from 7-13 parts of bighead atractylodes rhizome, 7-13 parts of poria cocos, 7-13 parts of red bean seeds, 5-10 parts of milkvetch roots, 5-10 parts of oriental wormwood, 5-10 parts of dandelions, 3-7 parts of semen armeniacae amarae, 3-7 parts of platycodon grandiflorum, 3-7 parts of pogostemon cablin, 2-3 parts of dried ginger and 2-3 parts of ginseng. A few number of medicine materials are adopted through specific dosage proportions, and the capsules can effectively treat gastric ulcers, duodenal ulcers and erosive gastritis, and a new pharmacy choice is provided for clinically treating peptic ulcers. Meanwhile, through pharmacodynamic tests, the modes of alcohol and water dual extraction and ginseng used as medicine in a powder mode are adopted, pharmacodynamic activity can be improved, and medicine material resources can be easily used economically.
Description
Technical field
The present invention relates to one and treat peptic ulcer capsule.
Background technology
Peptic ulcer mainly refers to betide the duodenal chronic ulcer of harmonization of the stomach.Wherein, taste-blindness rate refers to the circular or oval full-thickness defects of the limitation of Grastiodudenal mucosa, and muscularis mucosae is penetrated, and inevitably leaves fibrous scar after healing, and surface is covered by one deck epithelium, and muscularis mucosae can not regenerate.It is because many reasons causes gastric acid, pepsin to be destroyed the self-digestion of gastric mucosa or gastric mucosal barrier that its cause of disease sums up.Think that the formation of ulcer and gastric Helicobacter pylori infection also have important relationship in recent years.
Chronic erosive gastritis, also known as gastritis verrucosa or varioliform gastritis generally rarely seen glutted, indigestion symptom such as pantothenic acid, belch, irregularities stomachache after meal.There is multiple excipuliform in Stomach in Patients mucosa, expands folded shape or pimple sample protuberance, diameter 5 ~ 10mm, the visible mucomembranous defect in top or umbilicus sample depression, and there is erosion at center, and protuberance is many without blush around, but the normal erythema similar with size, with gastric antrum, portion is common.
The medicine of the above-mentioned disease of Current therapeutic mostly is chemical drugs, and it is expensive, and side effect is large, and it is long to cure required time.Therefore, urgent need one is economical and practical, toxic and side effects is low, and the medicine of the above-mentioned disease of energy rapid healing.
And Chinese medicine in treatment of chronic diseases one to all playing an important role.Report, with Concha Arcae 75% and Radix Glycyrrhizae 25%, red in pulv, treatment gastric and duodenal ulcers, cure rate reaches 76% (" Chinese medicine voluminous dictionary " second edition, Shanghai science tech publishing house, in March, 2006,548th ~ 549 pages); Also people is had with Os Sepiae (life) 250g, Concha Arcae (calcined) 250g, Radix Et Rhizoma Rhei 200g, Radix Glycyrrhizae Preparata 200g, grinds to the powder, and boiled water is taken after mixing it with water after meal, each 15g, every day 3 ~ 4 times, be used for the treatment of peptic ulcer (Gu Linjiang, Cuttlefish Bone Powder for Peptic Ulcer, journal of shanghai Chinese medicine, phase calendar year 2001 9.Also there is people to treat peptic ulcer with Fructus Amomi Rotundus 10g, Rhizoma Atractylodis Macrocephalae 20g, Poria 20g, Herba Pogostemonis 15g, Herba Taraxaci 15g, Radix Ginseng 5g, Folium Perillae 10g, Semen Armeniacae Amarum 10g, Semen Coicis 20g, Herba Artemisiae Scopariae 15g, there is good therapeutic effect.Chinese Patent Application No.: 201310259917.9, disclose a kind of pharmaceutical composition for the treatment of peptic ulcer, its proportioning raw materials is as follows: Radix Rhodiolae 4.2-7.2 part, Poria 14-26 part, Herba Taraxaci 10.5-19.5 part, Herba Artemisiae Scopariae 10.5-19.5 part, Rhizoma Atractylodis Macrocephalae 10.5-19.5 part, Herba Pogostemonis 7-13 part, Fructus Hordei Germinatus 7-13 part, Fructus Amomi Rotundus 3.5-6.5 part.This prescription drug can effectively treat gastric ulcer, duodenal ulcer and erosive gastritis.
But current Peptic Ulcers One's name is legion, supply falls short of demand for market medicine, therefore, develops a kind of new pharmaceutical composition effectively can treating peptic ulcer and seem particularly necessary.Meanwhile, mostly Chinese medicine material is based on decocting, but some effective ingredient is not soluble in water, loses again or in decocting process, therefore, in order to utilize herb resource better, needs to study the preparation method of pharmaceutical composition simultaneously.
Summary of the invention
One is the object of the present invention is to provide to treat peptic ulcer capsule.
The invention provides one and treat peptic ulcer capsule, it is that after mixing, prepare in incapsulating, wherein, drug particles prepares by the following method by drug particles 100 weight portion, lubricant 1 ~ 5 weight portion:
(1) Rhizoma Atractylodis Macrocephalae 7-13 part, Poria 7-13 part, Semen Phaseoli 7-13 part, Radix Astragali 5-10 part, Herba Artemisiae Scopariae 5-10 part, Herba Taraxaci 5-10 part, Semen Armeniacae Amarum 3-7 part, Radix Platycodonis 3-7 part, Herba Pogostemonis 3-7 part, Rhizoma Zingiberis 2-3 part, Radix Ginseng 2-3 part is got; Get other flavour of a drug except Radix Ginseng, first add 55-95%v/v ethanol extraction, filter, alcohol extract is for subsequent use, and filtering residue decocts with water again, and namely merging alcohol extract and decocting liquid obtain extract;
(2) in extract, add soluble starch: dextrin=(1 ~ 3): 1, total consumption of soluble starch and dextrin is 1.7 ~ 2.4 times of other medicinal substances extract dry weights except Radix Ginseng, after mix homogeneously, granulates, obtains drug particles.
Further, proportioning raw materials is as follows: the proportioning of described crude drug is as follows: Rhizoma Atractylodis Macrocephalae 9-11 part, Poria 9-11 part, Semen Phaseoli 9-11 part, Radix Astragali 7-8 part, Herba Artemisiae Scopariae 7-8 part, Herba Taraxaci 7-8 part, Semen Armeniacae Amarum 4-6 part, Radix Platycodonis 4-6 part, Herba Pogostemonis 4-6 part, Rhizoma Zingiberis 2-3 part, Radix Ginseng 2-3 part.
Preferably, the proportioning of described crude drug is as follows: the Rhizoma Atractylodis Macrocephalae 10 parts, 10 parts, Poria, Semen Phaseoli 10 parts, the Radix Astragali 7.5 parts, Herba Artemisiae Scopariae 7.5 parts, Herba Taraxaci 7.5 parts, Semen Armeniacae Amarum 5 parts, Radix Platycodonis 5 parts, Herba Pogostemonis 5 parts, Rhizoma Zingiberis 2.5 parts, Radix Ginseng 2.5 parts.The present invention studies discovery, and under this conditions of mixture ratios, its drug activity is significantly better than other proportionings, clear curative effect.
Preferably, soluble starch: dextrin=1:1.
Preferably, total consumption of soluble starch and dextrin is 2.0 ~ 2.1 times of other medicinal substances extract dry weights except Radix Ginseng.The present invention studies discovery, for the extract of medical material prescription of the present invention, only only has after soluble starch and dextrin being combinationally used by specific ratio and consumption, can be prepared into qualified drug particles.
Further, being prepared from by the following method of this drug particles:
Getting Radix Ginseng, to beat powder for subsequent use; Get other flavour of a drug except Radix Ginseng, first add 55-95%v/v ethanol extraction, filter, alcohol extract is for subsequent use, and filtering residue decocts with water again, after merging alcohol extract and decocting liquid, be concentrated into the thick paste that relative density is 1.28 ~ 1.30 (60 DEG C), add Radix Ginseng powder, soluble starch and dextrin again, wet granulation, obtain drug particles.
Find in experiment, the drug activity of ethanol on compositions of variable concentrations has appreciable impact, and preferably use 70%v/v ethanol in the present invention, in view of the error that may exist in alcoholic solution process for preparation, concentration of alcohol range set is 65 ~ 75%v/v by the present invention.
Wherein, adopt alcohol reflux 1 ~ 2 time, extract 1 ~ 2 hour, medical material: ethanol=1:8 ~ 12g/ml at every turn.
Wherein, decoct with water extraction 2 ~ 3 times, add water 8 ~ 12 times amount at every turn, decocts 20 ~ 40 minutes.
Wherein, described lubricant is selected from magnesium stearate or Pulvis Talci.
Wherein, described lubricant quantity is 2 ~ 4 parts.
Further, above-mentioned capsule, except drug particles and lubricant, in order to adjust capsule loading, or improves the character such as water absorption, can also contain filler, as microcrystalline Cellulose, starch, dextrin in described capsule.
In the present invention, Poria is the dry sclerotia of On Polyporaceae Poria Poriacocos (Schw.) Wolf.Sweet, light, flat.GUIXIN, lung, spleen, kidney channel.Promoting diuresis to eliminate damp pathogen, spleen invigorating, mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
Semen Phaseoli is the dry mature seed of leguminous plant Semen Phaseoli VignaumbeuataOhwietOhashi or Semen Phaseoli VignaangularisohwietOhashi.Sweet, sour, flat.GUIXIN, small intestine meridian.Inducing diuresis to remove edema, removing toxic substances and promoting pus discharge.For edema distension, beriberi edema, jaundice dark coloured urine, beriberoid pyretic arthralgia, carbuncle sore tumefacting virus, abdominalgia with intestinal abscess.
Herba Taraxaci is Herba Taraxaci TaraxacummongolicumHand.Mazz, alkali ground Herba Taraxaci TaraxacumborealisinenseKitam. or belong to the dry herb of several plants together.Bitter, sweet, cold.Return liver, stomach warp.Heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, inducing diuresis for treating stranguria syndrome.For furuncle swelling toxin, acute mastitis, scrofula, conjunctival congestion, pharyngalgia, lung abscess, acute appendicitis, jaundice due to damp-heat, the puckery pain of pyretic stranguria.
Herba Artemisiae Scopariae is that the quadrate part dryly of feverfew Artemisia scoparia Waldst. et Kit. ArtemisiascopariaWaldst.EtKit. or Herba Artemisiae Scopariae ArtemisiacapillariesThunb. divides.Bitter, pungent, be slightly cold, return spleen, stomach, liver, gallbladder meridian.Eliminating damp-heat, promoting the function of the gallbladder to alleviate jaundice.For jaundice oliguria, hygropyrexia heat-damp in summer, eczema pruritus.
The Rhizoma Atractylodis Macrocephalae is the dry rhizome of feverfew Rhizoma Atractylodis Macrocephalae AtractylodesmacrocephalaKoidz..Bitter, sweet, temperature, returns spleen, stomach warp.Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.
Semen Armeniacae Amarum is the dry mature seed of rosaceous plant Prunus armeniaca L.var.ansu Maxim. PrunusarmeniacaL.var.ansuMaxim., Siberia Fructus Pruni PrunussibiricaL., prunus mandshuricaKoehne Prunusmandshurica (Maxim.) Koehne or Fructus Pruni PrunusarmeniacaL..Bitter, tepor, slightly poisonous, return lung, large intestine channel.Sending down the abnormal ascending QI relieving cough and asthma, loosening bowel to relieve constipation.For cough and asthma, fullness in the chest abundant expectoration, dryness of the intestine constipation.
The Radix Astragali is the dry root of leguminous plant Radix Astagali Astragalusmembranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao or Radix Astragali Astragalusmembranaceus (Fisch.) Bge..Sweet, tepor.Return lung, spleen channel.Tonifying Qi and lifting yang, strengthening superficial resistance to stop perspiration, inducing diuresis to remove edema, promotes the production of body fluid and nourishes blood, the stagnant blood stasis dispelling of row, detoxification evacuation of pus, expelling pus and promoting granulation.Weak in the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, hemiplegia, and arthralgia pain is numb, and carbuncle difficulty is burst, and bursts for a long time and does not hold back.
Radix Platycodonis is the dry root of Campanulaceae Radix Platycodonis Platycodongrandiflorum (Jacq.) A.DC..Bitter, pungent, flat.Return lung meridian.Lung qi dispersing, sore-throat relieving, eliminates the phlegm, evacuation of pus.For cough with copious phlegm, uncomfortable in chest not smooth, pharyngalgia hoarseness, lung abscess vomiting pus.
Herba Pogostemonis is that the quadrate part dryly of labiate Herba Pogostemonis Pogostemoncablin (Blanco) Benth. divides.Pungent, tepor.Return spleen, stomach, lung meridian.Eliminating turbid pathogen with aromatics, and middle preventing or arresting vomiting, deliver expelling summer-heat.For turbid damp obstructing in middle-JIAO, gastral cavity painful abdominal mass is vomitted, heat-damp in summer exterior syndrome, hygropyrexia from the beginning of, heating asthenia, uncomfortable in chestly do not relax, cold-damp closes summer-heat, and stomachache is vomited and diarrhoea, nasosinusitis headache.
Rhizoma Zingiberis is the dry rhizome of zingiber ZingiberofficinaleRose..Pungent, heat.Return spleen, stomach, kidney, the heart, lung meridian.Warming spleen and stomach for dispelling cold, recuperating depleted YANG is promoted blood circulation, warming the lung to resolve fluid-retention.For coldness and pain in the epigastrium, vomiting is had loose bowels, and cold extremities faint pulse, cold fluid-retention is breathed with cough.
Radix Ginseng is the dry root welding technology of Araliaceae Radix Ginseng PanaxginsengC.A.Mey..Sweet, micro-hardship, tepor, return spleen, lung, the heart, kidney channel.Strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung, promotes the production of body fluid and nourish blood, Fructus Alpiniae Oxyphyllae of calming the nerves.For weak body and prostration, cold extremities faint pulse, insufficiency of the spleen lack of appetite, the deficiency of the lung is breathed with cough, and Tianjin wound is thirsty, and interior-heat is quenched one's thirst, deficiency of qi and blood, prolonged illness weakness with emaciation, palpitation with fear insomnia, sexual impotence cold womb.
Drug particles crude drug compatibility of the present invention is reasonable, and pharmaceutical composition of the present invention has played synergistic function, can effectively treat gastric ulcer, duodenal ulcer and erosive gastritis, selects for clinical treatment peptic ulcer provides a kind of new medication.Meanwhile, the present invention is by the test of pesticide effectiveness, and the present invention adopts the second alcohol and water of certain concentration to carry out the mode extracted, Radix Ginseng is used as medicine with powder, can improve drug activity, and the saving contributing to herb resource utilizes.
Detailed description of the invention
The preparation of embodiment 1 capsule of the present invention
(1) drug particles is prepared
Rhizoma Atractylodis Macrocephalae 10g, Poria 10g, Semen Phaseoli 10g, Radix Astragali 7.5g, Herba Artemisiae Scopariae 7.5g, Herba Taraxaci 7.5g, Semen Armeniacae Amarum 5g, Radix Platycodonis 5g, Herba Pogostemonis 5g, Rhizoma Zingiberis 2.5g, Radix Ginseng 2.5g; Get other flavour of a drug except Radix Ginseng, first add 10 times amount 70% alcoholic solution reflux, extract, 1 time, extract 1 hour, filter, filtrate is for subsequent use, and filtering residue uses soak by water 2 times again, add water 8 times amount at every turn, and each decoction 30 minutes, after merging ethanol extract and decocting liquid, be concentrated into the thick paste that relative density is 1.28 ~ 1.30 (60 DEG C), add Radix Ginseng powder again, and soluble starch: dextrin=1:1 totally 43 ~ 44g, wet granulation, dry, obtain drug particles of the present invention.
After measured, the dry cream rate of extracting method of the present invention is 29 ~ 30% (dry cream amount accounts for the ratio of extraction medical material total amount), must about 10g dry extract after every 17g thick paste bone dry, the consumption of soluble starch and dextrin is about the 2.0-2.1 of extract dry weight doubly.
(2) capsule is prepared
Get the drug particles 1000g prepared, add 30g magnesium stearate, after mixing, in incapsulating, obtain capsule.
The preparation of embodiment 2 capsule of the present invention
(1) drug particles is prepared
Rhizoma Atractylodis Macrocephalae 10g, Poria 10g, Semen Phaseoli 10g, Radix Astragali 7.5g, Herba Artemisiae Scopariae 7.5g, Herba Taraxaci 7.5g, Semen Armeniacae Amarum 5g, Radix Platycodonis 5g, Herba Pogostemonis 5g, Rhizoma Zingiberis 2.5g, Radix Ginseng 2.5g; Get other flavour of a drug except Radix Ginseng, first add 10 times amount 70% alcoholic solution reflux, extract, 1 time, extract 1 hour, filter, filtrate is for subsequent use, and filtering residue uses soak by water 2 times again, add water 8 times amount at every turn, and each decoction 30 minutes, after merging ethanol extract and decocting liquid, be concentrated into the thick paste that relative density is 1.28 ~ 1.30 (60 DEG C), add Radix Ginseng powder again, and soluble starch: dextrin=1:1 totally 43 ~ 44g, wet granulation, dry, obtain drug particles of the present invention.
After measured, the dry cream rate of extracting method of the present invention is 29 ~ 30% (dry cream amount accounts for the ratio of extraction medical material total amount), must about 10g dry extract after every 17g thick paste bone dry, the consumption of soluble starch and dextrin is about the 2.0-2.1 of extract dry weight doubly.
(2) capsule is prepared
Get the drug particles 1000g prepared, add 40g magnesium stearate, after mixing, in incapsulating, obtain capsule.
The preparation of embodiment 3 capsule of the present invention
(1) drug particles is prepared
Rhizoma Atractylodis Macrocephalae 10g, Poria 10g, Semen Phaseoli 10g, Radix Astragali 7.5g, Herba Artemisiae Scopariae 7.5g, Herba Taraxaci 7.5g, Semen Armeniacae Amarum 5g, Radix Platycodonis 5g, Herba Pogostemonis 5g, Rhizoma Zingiberis 2.5g, Radix Ginseng 2.5g; Get other flavour of a drug except Radix Ginseng, first add 10 times amount 70% alcoholic solution reflux, extract, 1 time, extract 1 hour, filter, filtrate is for subsequent use, and filtering residue uses soak by water 2 times again, add water 8 times amount at every turn, and each decoction 30 minutes, after merging ethanol extract and decocting liquid, be concentrated into the thick paste that relative density is 1.28 ~ 1.30 (60 DEG C), add Radix Ginseng powder again, and soluble starch: dextrin=1:1 totally 43 ~ 44g, wet granulation, dry, obtain drug particles of the present invention.
After measured, the dry cream rate of extracting method of the present invention is 29 ~ 30% (dry cream amount accounts for the ratio of extraction medical material total amount), must about 10g dry extract after every 17g thick paste bone dry, the consumption of soluble starch and dextrin is about the 2.0-2.1 of extract dry weight doubly.
(2) capsule is prepared
Get the drug particles 1000g prepared, add 20g magnesium stearate, after mixing, in incapsulating, obtain capsule.
The selection of embodiment 4 capsule adjuvant
1 different auxiliary material is on the impact of granulating
Thick paste (about 17g) three parts is taken by extract dry weight 10g, add dried soluble starch, dextrin, soluble starch-dextrin (1:1), soluble starch-dextrin (1:3), soluble starch-dextrin (1:5) each 13g respectively, mix homogeneously, granulate when not adding ethanol, investigate the outward appearance etc. of soft material situation, difficulty or ease of sieving and granule, the results are shown in Table 1.
Table 1 adjuvant is on the impact of granulating
Conclusion: when soluble starch-dextrin is (3:1), (1:1), granulation situation is better, and granule color and luster is dark, epigranular.
2 different auxiliary material are investigated granule hydroscopicity and melting
Get the glass desicator that bottom fills NaCl supersaturated solution, the built-in weighing botle of exsiccator, puts into 25 DEG C of thermostatic drying chamber constant temperature 48 hours, and the relative humidity now in exsiccator is 75%.Bottom the weighing botle being dried to constant weight, put into the thick granule about measured needed for 2mm, to be accurately weighedly placed in above-mentioned exsiccator, open weighing bottle cap, in the weight of 4,8,12,24,48h accurate weighing bottle and granule, calculate Moisture percentage.Result of the test is in table 2.
Table 2 Moisture percentage measurement result table
Conclusion: when adjuvant adds dextrin, soluble starch-dextrin (1:1), soluble starch-dextrin (3:1), microcrystalline Cellulose, the hygroscopicity of granule is all lower, but the granule that microcrystalline Cellulose obtains does not meet melting requirement, and have lamination, in conjunction with the investigation to granulation situation, finally select soluble starch-dextrin (1:1) as the adjuvant of drug particles.
The investigation of 3 supplementary product consumptions
Take thick paste (about 17g) by extract dry weight 10g, totally three parts, add 1.7-1.8 respectively, 2.0-2.1,2.3-2.4 times of soluble starch-dextrin (1:1), granulates, with the qualification rate of granule, situation of sieving for index, select optimal supplementary product consumption.The results are shown in Table 3.
The investigation result of table 3 different auxiliary material consumption
Conclusion: supplementary product consumption is the 1.7-1.8 of extract dry weight, 2.0-2.1, during 2.3-2.4 times, the granule qualification rate made all meets the requirements, but this drug particles later stage needs tabletting, if viscosity too large (as granule to rise, sticky sieve), capsule sticking can be caused, if year too low (not the group of rising, fine powder many), easily cause again slice, thin piece loose.In conjunction with tabletting situation, final selection supplementary product consumption is 2.0-2.1 times of thick paste amount.
Beneficial effect of the present invention is shown further below by way of concrete test example.
Test example 1 pharmaceutical composition of the present invention is to the treatment of gastric ulcer
Gastric Ulcer standard: upper abdomen dull pain, dull pain or burn sample pain, alleviate after taking alkalescent medicine, such pain has rhythmicity, many appearance in 1 hour after the meal, alleviated gradually after 1 ~ 2 hour, generally also there will be acid regurgitation, belch, heartburn, the indigestion symptom such as Abdeminal pain, Nausea and vomiting; The visible niche of upper digestive tract radiography; Endoscopy, can in stomach see circle or oval, bottom is smooth, the ulcer of neat in edge, ulcer surface is greyish white or brown tongue film covers, edge swelling, color and luster ruddy, smooth and soft (i.e. gastric ulcer activity time).Accept 40 examples altogether for medical treatment, endoscopy confirms as gastric ulcer.
Criterion of cure: epigastrium pain disappears, endoscopy, and visible ulcer surface white fur disappears, become red congested cicatrix, visible pleat concentrates (i.e. cicatricial phase).
Effective standard: epigastrium pain disappears or alleviates, endoscopy, and tongue film is thinning, and ulcer reduces, the blush of visible mucous epithelium regeneration around it; Or ulcer surface almost disappears, it there is few thin coating (i.e. healing stage).
Therapeutic Method: prepare decoction as follows:
Rhizoma Atractylodis Macrocephalae 10g, Poria 10g, Semen Phaseoli 10g, Radix Astragali 7.5g, Herba Artemisiae Scopariae 7.5g, Herba Taraxaci 7.5g, Semen Armeniacae Amarum 5g, Radix Platycodonis 5g, Herba Pogostemonis 5g, Rhizoma Zingiberis 2.5g, Radix Ginseng 2.5g; Decoct with water 3 times, first time adds 10 times amount soak by water 5 minutes, and second time adds 8 times amount soak by water 10 minutes, and third time adds 8 times amount soak by water 15 minutes, filters, and after merging decocting liquid, obtains pharmaceutical composition decoction of the present invention.
Every bu is taken for 3 times, period in a medicine, avoids eating anything raw or cold, maror.
Criterion of cure: take medicine continuously by Therapeutic Method, treats 20 ~ 40 days, cures 35 examples, accounts for 87% of total case; Effective 5 examples, account for 13% of total case.Total effective rate reaches 100%.
Test example 2 pharmaceutical composition of the present invention is to the treatment of duodenal ulcer
Duodenal ulcer diagnostic criteria: epigastrium dull pain, causalgia, distending pain or severe pain, also can be the only dull pain discomfort when hunger, or appearance is slight or rest pain under moderate xiphoid-process, can be alleviated by antacid or feed, early within 1 ~ 3 hour after the meal, start to occur upper abdominal pain, if do not taken medicine or taking food, just alleviate after continuing to lunch, food also must have meal to alleviate for latter 2 ~ 4 hours again bitterly.Endoscopy, thick fur and filthy, it can have petechia, sludged blood, and around the obvious congestion and edema of mucosa is rotten to the corn; Or tongue is still thicker, around mucosal inflammation edema alleviates, and red re-epithelialize (active stage) can appear in ulcer edge.Accept 30 examples altogether for medical treatment, endoscopy confirms as duodenal ulcer.
Therapeutic Method: with test example 1.
Criterion of cure: pain disappears, endoscopy, white fur disappears, and replaces red epithelium and cicatrix; Or re-epithelialize redness disappears, cicatrix color white (i.e. cicatricial phase).Take medicine continuously by Therapeutic Method, treat 15 ~ 20 days, cure 30 examples, account for 100% of total case.
Test example 3 pharmaceutical composition of the present invention is to the treatment of chronic erosive gastritis
Chronic erosive gastritis diagnostic criteria: occur the indigestion symptoms such as glutted, acid regurgitation, belch, irregularities stomachache, massive bleeding from upper digestive tract can be occurred, occur hematemesis, melena, shock, normal easily recurrence after stopped bleeding; Endoscopy, visible gastric mucosa congestion and edema, some lamellar is rotten to the corn, the multiple ulcer differed in size, ulcer surface can have fresh go out clot.Accept 22 examples altogether for medical treatment, endoscopy confirms as chronic erosive gastritis.
Therapeutic Method: with test example 1.
Criterion of cure: the indigestion symptom such as acid regurgitation, stomachache disappears, endoscopy, without point-like or lamellar erosion, mucosa edema disappears, and gastric mucosa heals.Take medicine continuously by Therapeutic Method, treat 20 ~ 30 days, cure 22 examples, account for 100% of total case.
Model case 1
Lee, man, 29 years old, when morning rises, distended tummy sense was obvious especially, and ante cibum 1, the phenomenon of belch, acid regurgitation appearred in hours, anorexia, and body weight obviously alleviates, painless; Through gastroscopy, confirm as erosive gastritis.
After taking medicine 7 days by test example 1 method, feeling of repletion, belch phenomenon are alleviated, and after 15 days, appetite has recovered suitable with normal period, acid regurgitation, belch phenomenon disappear, after 25 days, through gastroscopy, ulcer surface heals, and conscious appetite, stomach are felt good, and body weight is gone up.
The screening of test example 4 pharmaceutical composition of the present invention
Get SD rat, male and female half and half fasting is after 12 hours, rats by intraperitoneal injection 3% is anaesthetized without barbital sodium, to sterilize skin with alcohol cotton stick, cut abdominal cavity open, in glandular stomach portion, antetheca hole body intersection serosal surface sticks the circular filter paper 30s soaking into glacial acetic acid, diameter 5mm, repeat 3 times, close abdomen sewing-up cut, be coated with penicillin.Postoperative routine feeding, the 4th day by animal random packet, model group gavage 10mlkg
-1distilled water, positive drug ranitidine group gavage 30mgkg
-1, each screening group 10g crude drug/kg body weight (extracting method is with test example 1) of the present invention.The 2nd day after grouping starts gastric infusion, and administration every day 1 time, dosage is 10mlkg
-1, continuous 5 days, last administration is de-cervical vertebra execution animal after 12 hours, cut open the belly and get stomach, use brine gastric content, stomach is fixed in 10% formaldehyde, stomach is lain on glass surface ware after 15 minutes, measure major diameter and the minor axis of ulcer surface under magnifier with slide gauge, and calculate ulcer surface.
Calculate ulcer inhibition rate: ulcer inhibition rate=(matched group ulcer area-administration group ulcer area)/matched group ulcer area x100%, observe ulcer healing degree.
Experimental result is in table 4
Table 4
Note: compared with model group, * is p<0.05, * * is p<0.01; Compared with group 4, △ is p<0.05
Wherein, the compatibility of each screening group is as follows:
Group 1: the Rhizoma Atractylodis Macrocephalae 15 parts, 15 parts, Poria, Semen Phaseoli 7 parts, the Radix Astragali 5 parts, Herba Artemisiae Scopariae 5 parts, Herba Taraxaci 15 parts, Semen Armeniacae Amarum 8 parts, Radix Platycodonis 8 parts, Herba Pogostemonis 7 parts, Rhizoma Zingiberis 1 part, Radix Ginseng 4 parts;
Group 2: the Rhizoma Atractylodis Macrocephalae 12 parts, 12 parts, Poria, Semen Phaseoli 12 parts, the Radix Astragali 7.5 parts, Herba Artemisiae Scopariae 7.5 parts, Herba Taraxaci 10 parts, Semen Armeniacae Amarum 3 parts, Radix Platycodonis 3 parts, Herba Pogostemonis 10 parts, Rhizoma Zingiberis 4 parts, Radix Ginseng 5 parts;
Group 3: the Rhizoma Atractylodis Macrocephalae 7 parts, 7 parts, Poria, Semen Phaseoli 10 parts, the Radix Astragali 9 parts, Herba Artemisiae Scopariae 10 parts, Herba Taraxaci 10 parts, Semen Armeniacae Amarum 5 parts, Radix Platycodonis 6 parts, Herba Pogostemonis 5 parts, Rhizoma Zingiberis 2.5 parts, Radix Ginseng 2.5 parts;
Group 4: the Rhizoma Atractylodis Macrocephalae 10 parts, 10 parts, Poria, Semen Phaseoli 10 parts, the Radix Astragali 7.5 parts, Herba Artemisiae Scopariae 7.5 parts, Herba Taraxaci 7.5 parts, Semen Armeniacae Amarum 5 parts, Radix Platycodonis 5 parts, Herba Pogostemonis 5 parts, Rhizoma Zingiberis 2.5 parts, Radix Ginseng 2.5 parts.
Above-mentioned each group of compound recipe, flavour of a drug are identical, but medical material consumption proportion difference has appreciable impact to the drug activity of compound recipe: group 1-3, all has certain inhibitory action (p<0.05) to the gastric ulcer of animal pattern; But the prescription proportioning of employing group 4, can significantly improve the therapeutic activity of compound medicine, and its activity is significantly better than other each proportioning groups (p<0.05), and therefore, the present invention preferably organizes the prescription proportioning of 4.Above-mentioned test shows, pharmaceutical composition of the present invention, under specific proportioning, has played synergistic function.
Test example 5 pharmaceutical composition of the present invention is to the therapeutical effect of acetic acid type gastric ulcer
Get SD rat, fasting is after 12 hours, and rats by intraperitoneal injection 3% is anaesthetized without barbital sodium, to sterilize skin with alcohol cotton stick, cut abdominal cavity open, in glandular stomach portion, antetheca hole body intersection serosal surface sticks the circular filter paper 30s soaking into glacial acetic acid, diameter 5mm, repeat 3 times, close abdomen sewing-up cut, be coated with penicillin.Postoperative routine feeding, is divided into 6 groups at random by animal on the 4th day, and often organize 10, male and female half and half, are respectively model group (10mlkg
-1distilled water), pharmaceutical composition senior middle school of the present invention low dose group (be followed successively by 10,20,40g crude drug/kg body weight), contrast groups 1 (20g crude drug/kg body weight), contrast groups 2 (20g crude drug/kg body weight), positive drug ranitidine group (30mgkg
-1).The 2nd day after grouping starts gastric infusion, and administration every day 1 time, dosage is 10mlkg
-1, continuous 5 days, last administration is de-cervical vertebra execution animal after 12 hours, cut open the belly and get stomach, use brine gastric content, stomach is fixed in 10% formaldehyde, stomach is lain on glass surface ware after 15 minutes, measure major diameter and the minor axis of ulcer surface under magnifier with slide gauge, and calculate ulcer surface.
Calculate ulcer inhibition rate: ulcer inhibition rate=(matched group ulcer area-administration group ulcer area)/matched group ulcer area x100%, observe ulcer healing degree.
Pharmaceutical composition of the present invention is prepared by test example 1;
The preparation method of contrast groups 1 medicine is as follows:
Get Fructus Amomi Rotundus 10g, Rhizoma Atractylodis Macrocephalae 20g, Poria 20g, Herba Pogostemonis 15g, Herba Taraxaci 15g, Radix Ginseng 5g, Folium Perillae 10g, Semen Armeniacae Amarum 10g, Semen Coicis 20g, Herba Artemisiae Scopariae 15g; Decoct with water 3 times, first time adds 10 times amount soak by water 5 minutes, and second time adds 8 times amount soak by water 10 minutes, and third time adds 8 times amount soak by water 15 minutes, filters, and after merging decocting liquid, obtains contrast groups 1 decoction.
The preparation method of contrast groups 2 medicine is as follows:
Semen Coicis 20 parts, Semen Benincasae 20 parts, Herba Artemisiae Scopariae 15 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Folium Perillae 10 parts, Semen Armeniacae Amarum 10 parts, Semen Lablab Album 10 parts, Semen Myristicae 10 parts, the Radix Astragali 10 parts, Radix Ginseng 5 parts, Fructus Forsythiae 5 parts.First add 4 times amount water soaking 10 minutes, then decoct with water 2 times, each 20 minutes, add water 10 times amount at every turn, filters, and after merging decocting liquid, obtains contrast groups 2 decoction.
Experimental result is in table 5.
Table 5
Note: compared with model group, * is p<0.05, * * is p<0.01; Compared with low dose group of the present invention, △ is p<0.05.
As shown in Table 2:
(1) pharmaceutical composition of the present invention, effectively can treat gastric ulcer, simultaneously, compared with contrast groups 1, although medicine composition is similar, but pharmaceutical composition of the present invention is all obviously being better than contrast groups 1 (p<0.05) compared with the drug activity under low dosage or Isodose;
(2) compared with contrast groups 2, the present invention is low dosage (10gKg comparatively
-1) time ulcer inhibitory action just suitable with contrast groups 2, during Isodose, drug activity of the present invention is more notable is better than contrast groups 2.
Above-mentioned experiment shows, pharmaceutical composition of the present invention, after the rational concerted application of drugs of screening, has played synergistic function.
Test example 6 pharmaceutical composition of the present invention is to the therapeutical effect of duodenal ulcer rat model
Get SD rat, male and female half and half, after anesthesia, by improvement Okabe method, get the glass tubing of internal diameter 3mm, vertical flicking on 0.5cm place duodenum antetheca serosal surface, injects 70% acetic acid 0.075ml, after 15s under pylorus in this pipe, sucking-off acetic acid, closes abdomen, obtains duodenal ulcer model.Postoperative 4 days, rat is divided into model group (10mlkg
-1distilled water), pharmaceutical composition senior middle school of the present invention low dose group (be followed successively by 10,20,40g crude drug/kg body weight), contrast groups (20g crude drug/kg body weight), positive drug omeprazole group (converting by quantity), gavage is after 7 days respectively, put to death rat, take out duodenum and observe ulcer inhibition rate.
Pharmaceutical composition of the present invention is prepared by test example 1;
The preparation method of contrast groups 1 medicine is as follows:
Get Fructus Amomi Rotundus 10g, Rhizoma Atractylodis Macrocephalae 20g, Poria 20g, Herba Pogostemonis 15g, Herba Taraxaci 15g, Radix Ginseng 5g, Folium Perillae 10g, Semen Armeniacae Amarum 10g, Semen Coicis 20g, Herba Artemisiae Scopariae 15g; Decoct with water 3 times, first time adds 10 times amount soak by water 5 minutes, and second time adds 8 times amount soak by water 10 minutes, and third time adds 8 times amount soak by water 15 minutes, filters, and after merging decocting liquid, obtains contrast groups 1 decoction.
The preparation method of contrast groups 2 medicine is as follows:
Semen Coicis 20 parts, Semen Benincasae 20 parts, Herba Artemisiae Scopariae 15 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, Folium Perillae 10 parts, Semen Armeniacae Amarum 10 parts, Semen Lablab Album 10 parts, Semen Myristicae 10 parts, the Radix Astragali 10 parts, Radix Ginseng 5 parts, Fructus Forsythiae 5 parts.First add 4 times amount water soaking 10 minutes, then decoct with water 2 times, each 20 minutes, add water 10 times amount at every turn, filters, and after merging decocting liquid, obtains contrast groups 2 decoction.
The results are shown in Table 6.
Table 6
Note: compared with model group, * is p<0.05, * * is p<0.01; Compared with low dose group of the present invention, △ is p<0.05.
As shown in Table 3, pharmaceutical composition of the present invention, effectively can treat duodenal ulcer, meanwhile, compared with contrast groups 1, although medicine composition is similar, but the drug activity of pharmaceutical composition of the present invention under Isodose is obviously better than contrast groups (p<0.05); Compared with contrast groups 2, the present invention is low dosage (10gKg comparatively
-1) time ulcer inhibitory action just suitable with contrast groups 2, during Isodose, drug activity of the present invention is more notable is better than contrast groups 2.
This just shows, pharmaceutical composition of the present invention, after the rational concerted application of drugs of screening, has played synergistic function.
The investigation of test example 7 extracting method of the present invention
Prescription: Rhizoma Atractylodis Macrocephalae 10g, Poria 10g, Semen Phaseoli 10g, Radix Astragali 7.5g, Herba Artemisiae Scopariae 7.5g, Herba Taraxaci 7.5g, Semen Armeniacae Amarum 5g, Radix Platycodonis 5g, Herba Pogostemonis 5g, Rhizoma Zingiberis 2.5g, Radix Ginseng 2.5g
Preparation method one:
Get prescription medical material, add 8 times amount soak by water 3 times, each 10 minutes, filter, merge decocting liquid, obtain method one extract A.
Preparation method two:
By prescription weighting raw materials; Get other flavour of a drug except Radix Ginseng, first add 10 times amount 70% alcoholic solution reflux, extract, 1 time, extract 1 hour, filter, filtrate is for subsequent use, and filtering residue uses soak by water 2 times again, and add water 8 times amount at every turn, each decoction 30 minutes, after merging ethanol extract and decocting liquid, concentrated, then add Radix Ginseng powder, mixing, obtains method two extract B.
Preparation method three:
By prescription weighting raw materials; Get other flavour of a drug except Radix Ginseng, first add 10 times amount 85% alcoholic solution reflux, extract, 1 time, extract 1 hour, filter, filtrate is for subsequent use, and filtering residue uses soak by water 2 times again, and add water 8 times amount at every turn, each decoction 30 minutes, after merging ethanol extract and decocting liquid, concentrated, then add Radix Ginseng powder, mixing, obtains method two extract C.
Preparation method four:
By prescription weighting raw materials; Get other flavour of a drug except Radix Ginseng, first add 10 times amount 55% alcoholic solution reflux, extract, 1 time, extract 1 hour, filter, filtrate is for subsequent use, and filtering residue uses soak by water 2 times again, and add water 8 times amount at every turn, each decoction 30 minutes, after merging ethanol extract and decocting liquid, concentrated, then add Radix Ginseng powder, mixing, obtains method three extract D.
Test method:
Get SD rat, fasting is after 12 hours, and rats by intraperitoneal injection 3% is anaesthetized without barbital sodium, to sterilize skin with alcohol cotton stick, cut abdominal cavity open, in glandular stomach portion, antetheca hole body intersection serosal surface sticks the circular filter paper 30s soaking into glacial acetic acid, diameter 5mm, repeat 3 times, close abdomen sewing-up cut, be coated with penicillin.Postoperative routine feeding, gives extract A, B and C, dosage on the 4th day respectively.The 2nd day after grouping starts gastric infusion, and administration every day 1 time, dosage is 10mlkg
-1, continuous 5 days, last administration is de-cervical vertebra execution animal after 12 hours, cut open the belly and get stomach, use brine gastric content, stomach is fixed in 10% formaldehyde, stomach is lain on glass surface ware after 15 minutes, measure major diameter and the minor axis of ulcer surface under magnifier with slide gauge, and calculate ulcer surface.
Calculate ulcer inhibition rate: ulcer inhibition rate=(matched group ulcer area-administration group ulcer area)/matched group ulcer area x100%, observe ulcer healing degree.
Experimental result is in table 7.
Table 7
Note: compared with extract A group, * is p<0.05; Compared with extract B, △ is p<0.05
As seen from the above table, medicine of the present invention all can play good ulcer treatment effect through decocting and two the carrying of alcohol water.
Meanwhile, method two, three, four is compared, and concentration of alcohol is about 70% time, and the therapeutic activity of extract is best, is significantly better than the ethanol extraction of 55%, 85% concentration, therefore, and the solvent that the present invention preferably uses 70% concentration ethanol to carry for alcohol water is two.
In sum, pharmaceutical composition of the present invention is after reasonable compatibility, pharmaceutical composition of the present invention has played synergistic function, can effectively treat gastric ulcer, duodenal ulcer and erosive gastritis, selects for clinical treatment peptic ulcer provides a kind of new medication.
Claims (10)
1. treat a peptic ulcer capsule, it is characterized in that: it is by drug particles 100 weight portion, lubricant 1 ~ 5 weight portion, after mixing, prepares in incapsulating; Wherein, drug particles prepares by the following method:
(1) Rhizoma Atractylodis Macrocephalae 7-13 part, Poria 7-13 part, Semen Phaseoli 7-13 part, Radix Astragali 5-10 part, Herba Artemisiae Scopariae 5-10 part, Herba Taraxaci 5-10 part, Semen Armeniacae Amarum 3-7 part, Radix Platycodonis 3-7 part, Herba Pogostemonis 3-7 part, Rhizoma Zingiberis 2-3 part, Radix Ginseng 2-3 part is got; Get other flavour of a drug except Radix Ginseng, first add 55-95%v/v ethanol extraction, filter, alcohol extract is for subsequent use, and filtering residue decocts with water again, and namely merging alcohol extract and decocting liquid obtain extract;
(2) in extract, add soluble starch: dextrin=(1 ~ 3): 1, total consumption of soluble starch and dextrin is 1.7 ~ 2.4 times of other medicinal substances extract dry weights except Radix Ginseng, after mix homogeneously, granulates, obtains drug particles.
2. raw material according to claim 1, is characterized in that: proportioning raw materials is as follows: the proportioning of described crude drug is as follows: Rhizoma Atractylodis Macrocephalae 9-11 part, Poria 9-11 part, Semen Phaseoli 9-11 part, Radix Astragali 7-8 part, Herba Artemisiae Scopariae 7-8 part, Herba Taraxaci 7-8 part, Semen Armeniacae Amarum 4-6 part, Radix Platycodonis 4-6 part, Herba Pogostemonis 4-6 part, Rhizoma Zingiberis 2-3 part, Radix Ginseng 2-3 part.
3. crude drug according to claim 2, is characterized in that: the proportioning of described crude drug is as follows: the Rhizoma Atractylodis Macrocephalae 10 parts, 10 parts, Poria, Semen Phaseoli 10 parts, the Radix Astragali 7.5 parts, Herba Artemisiae Scopariae 7.5 parts, Herba Taraxaci 7.5 parts, Semen Armeniacae Amarum 5 parts, Radix Platycodonis 5 parts, Herba Pogostemonis 5 parts, Rhizoma Zingiberis 2.5 parts, Radix Ginseng 2.5 parts.
4. adjuvant according to claim 1, is characterized in that: soluble starch: dextrin=1:1.
5. the adjuvant according to claim 1 or 4, is characterized in that: total consumption of soluble starch and dextrin is 2.0 ~ 2.1 times of other medicinal substances extract dry weights except Radix Ginseng.
6. drug particles according to claims 1 to 5, is characterized in that: being prepared from by the following method of this drug particles:
Getting Radix Ginseng, to beat powder for subsequent use; Get other flavour of a drug except Radix Ginseng, first add 55-95%v/v ethanol extraction, filter, alcohol extract is for subsequent use, and filtering residue decocts with water again, after merging alcohol extract and decocting liquid, be concentrated into the thick paste that relative density is 1.28 ~ 1.30 (60 DEG C), add Radix Ginseng powder, soluble starch and dextrin again, wet granulation, obtain drug particles.
7. the preparation method according to claim 1 or 6, is characterized in that: concentration of alcohol is 65 ~ 75%v/v, is preferably 70%v/v; Adopt alcohol reflux 1 ~ 2 time, extract 1 ~ 2 hour, medical material: ethanol=1:8 ~ 12g/ml at every turn.
8. preparation method according to claim 7, is characterized in that: decoct with water extraction 2 ~ 3 times, and add water 8 ~ 12 times amount at every turn, decocts 20 ~ 40 minutes.
9. capsule according to claim 1, is characterized in that: described lubricant quantity is 2 ~ 4 parts; Described lubricant is selected from magnesium stearate or Pulvis Talci.
10. capsule according to claim 1, is characterized in that: also containing filler in described capsule, as microcrystalline Cellulose, starch, dextrin.
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