CN102145014B - Pharmaceutical composition for treating peptic ulcer, preparation method and use of pharmaceutical composition - Google Patents

Pharmaceutical composition for treating peptic ulcer, preparation method and use of pharmaceutical composition Download PDF

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CN102145014B
CN102145014B CN2011100611336A CN201110061133A CN102145014B CN 102145014 B CN102145014 B CN 102145014B CN 2011100611336 A CN2011100611336 A CN 2011100611336A CN 201110061133 A CN201110061133 A CN 201110061133A CN 102145014 B CN102145014 B CN 102145014B
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pharmaceutical composition
preparation
vinegar
ulcer
endoconcha sepiae
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CN102145014A (en
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刘仲明
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Liu Dong
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Abstract

The invention discloses a pharmaceutical composition for treating peptic ulcer, comprising formulation prepared by the following raw materials by weight: 4-6 parts of vinegar concha arcae and 1 part of cuttlebone. The invention further discloses a preparation method and use of the pharmaceutical composition. The pharmaceutical composition is free from side toxic effect and capable of efficiently treating stomach, gastroduodenal ulcer, erosive duodenum and chronic erosive gastritis; through clinical verification, the pharmaceutical composition can rapidly relieve clinic symptoms of ached upper stomach and the like; the curing time is short, and the curing rate is 100%. The invention provides new selection for clinical application for treating peptic ulcer, the erosive duodenum and the chronic erosive gastritis.

Description

A kind of pharmaceutical composition for the treatment of peptic ulcer and its production and use
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of peptic ulcer, and its production and use.Belong to drug world.
Background technology
Stomach duodenum ulcer refers to the circular or oval full-thickness defects of the limitation of Grastiodudenal mucosa, and muscularis mucosae is penetrated, and leaves inevitably fibrous scar after the healing, and the surface is covered by one deck epithelium, and muscularis mucosae can not be regenerated.Its cause of disease sum up be since many reasons to cause gastric acid, pepsin destroyed to self-digestion or the gastric mucosal barrier of gastric mucosa.Think that in recent years formation and the gastric Helicobacter pylori infection of ulcer also have important relationship.
Chronic erosive gastritis claims again the indigestion symptoms such as general rarely seen after meal glutted, the pantothenic acid of gastritis verrucosa or varioliform gastritis, belch, irregularities stomachache.A plurality of excipuliforms appear in the Stomach in Patients mucosa, expand folded shape or pimple sample protuberance, diameter 5~10mm, and the visible Mucosa Defect in top or umbilicus sample depression, there is erosion at the center, and many without blush around the protuberance, but normal with the similar erythema of size, section is common with gastric antrum.
Duodenal erosion is the shallow depression of mucous layer, and its degree of depth is not passed muscularis mucosae, the point-like that takes on a red color, and diameter is generally less than 0.5cm.Do not stay cicatrix after the healing.
The medicine of the above-mentioned disease of current treatment mostly is chemical drugs, and it is expensive, and side effect is large, and the healing required time is long.Therefore, be badly in need of a kind of economical and practical, toxic and side effects is low, and can rapid healing the medicine of above-mentioned disease.
Concha Arcae is the shell of the animal Scapharca subcrenata Arca subcrenata Lischke of Carnis Arca inflata section, Tegillarca granosa Arca granosaLinnaeus or Scapharca broughtonii Arca inflate Reeve, salty in the mouth, and property is flat, returns liver, lung, stomach warp, expectorant blood stasis dispelling, hard masses softening and resolving, relieving gastric hyperacidity to alleviate stomachache.Endoconcha Sepiae is the dry inner shell of Sepiidae animal sepiella maindroni de Rochebrune Sepiellamaindroni de Rochebrune or golden cuttlefish Sepia esculenta Hoyle, and salty in the mouth, puckery is warm in nature, returns spleen, kidney channel, astringing to arrest bleeding, relieving leukorrhea by astringents, antacid, sore can be used for the acid regurgitation of having a stomachache, Peptic Ulcers etc.Report that 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, the 548th~549 page); Human Os Sepiae (life) 250g, Concha Arcae (calcined) 250g are also arranged, 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, 9 phases of calendar year 2001); Among the people also multiplex Concha Arcae (vinegar is forged 7 times) 270g, Os Sepiae 180g, Pericarpium citri reticuatae chachiensis (stir-fry) 90g grinds to the powder, every day 3 times, each 6g, boiled water send down the acid regurgitation water that treats for stomachache, eructation, very then haematemesis person after the food.
At present, yet there are no the report of only using vinegar Concha Arcae and Endoconcha Sepiae compound treatment peptic ulcer, chronic erosive gastritis and duodenal erosion.
Summary of the invention
Technical program of the present invention lies in providing the medicine of a kind of effective treatment chronic erosive gastritis, gastric ulcer, duodenal erosion and duodenal ulcer, particularly, the invention provides a kind of pharmaceutical composition for the treatment of digestive tract ulcer, it is the preparation that the crude drug by following weight proportion is prepared from:
4~6 parts of vinegar Concha Arcaes, 1 part of Endoconcha Sepiae.
Further, it is the preparation that the crude drug by following weight proportion is prepared from:
5~6 parts of vinegar Concha Arcaes, 1 part of Endoconcha Sepiae.
Further preferably, it is the preparation that the crude drug by following weight proportion is prepared from:
5.5 parts of vinegar Concha Arcaes, 1 part of Endoconcha Sepiae.
Wherein, described preparation is to be active component by the water of the crude drug of raw material medicated vinegar Concha Arcae and Endoconcha Sepiae or crude drug or extractive with organic solvent, adds what pharmaceutically available adjuvant or complementary composition were prepared from.
Wherein, described preparation is oral formulations.
Further, described oral formulations is powder, granule, pill, capsule, tablet or drop pill.
The present invention also provides a kind of method for preparing above-mentioned pharmaceutical composition, and concrete operation step is as follows:
(1) gets 4~6 parts of vinegar Concha Arcaes, 1 part of Endoconcha Sepiae;
(2) vinegar Concha Arcae, Endoconcha Sepiae are pulverized, sieve, add that pharmaceutically available adjuvant or complementary composition are prepared into preparation.
The present invention also provides the above-mentioned purposes of pharmaceutical composition in the medicine of preparation treatment chronic erosive gastritis.
The present invention also provides the above-mentioned purposes of pharmaceutical composition in the medicine of preparation treatment gastric ulcer.
The present invention also provides the above-mentioned purposes of pharmaceutical composition in the medicine of preparation treatment duodenal erosion.
The present invention also provides the above-mentioned purposes of pharmaceutical composition in the medicine of preparation treatment duodenal ulcer.
Used vinegar Concha Arcae in the pharmaceutical composition of the present invention is to get clean Concha Arcae to put in the appropriate vessel, forges in smokeless stove fire to crisp, takes out and pours in the vinegar, makes quench in vinegar even, dries, and is ground into fine powder.The used vinegar Concha Arcae of writing out a prescription can by existing concocting method self-control, also can be bought the commercial goods and obtain.
Pharmaceutical composition of the present invention has no side effect, can effectively treat Stomach duodenum ulcer, duodenal erosion and chronic erosive gastritis, through clinical verification, this pharmaceutical composition can the rapid recovery Upper abdominal pain etc. clinical symptoms, healing time is short, cure rate provides the new selection of clinical application up to 100% for treatment peptic ulcer, duodenal erosion and chronic erosive gastritis.
Below by the specific embodiment, foregoing of the present invention is described in further detail again.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
The preparation of embodiment 1 pharmaceutical composition of the present invention
Get vinegar Concha Arcae 5.5g, Endoconcha Sepiae 1g after the pulverizing, crosses 100 mesh sieves, and is encapsulated behind the mix homogeneously, namely gets capsule of the present invention, about every loading amount 0.7g.
The preparation of embodiment 2 pharmaceutical compositions of the present invention
Get vinegar Concha Arcae 5g, Endoconcha Sepiae 1g after the pulverizing, crosses 120 mesh sieves, and is encapsulated behind the mix homogeneously, namely gets capsule of the present invention, about every loading amount 0.7g.
The preparation of embodiment 3 pharmaceutical compositions of the present invention
Get vinegar Concha Arcae 6g, Endoconcha Sepiae 1g after the pulverizing, crosses 100 mesh sieves, and is encapsulated behind the mix homogeneously, namely gets capsule of the present invention, about every loading amount 0.7g.
The preparation of embodiment 4 pharmaceutical compositions of the present invention
Get vinegar Concha Arcae 40g, Endoconcha Sepiae 10g after the pulverizing, crosses 120 mesh sieves, behind the mix homogeneously, namely gets powder of the present invention.
The preparation of embodiment 5 pharmaceutical compositions of the present invention
Get vinegar Concha Arcae 60g, Endoconcha Sepiae 10g after the pulverizing, crosses 80~100 mesh sieves, behind the mix homogeneously, adds an amount of dextrin, steviosin after, granulation namely gets granule of the present invention.
The preparation of embodiment 6 pharmaceutical compositions of the present invention
Get the granule that embodiment 3 prepares, add an amount of magnesium stearate, behind the tabletting, prepare tablet of the present invention.
The preparation of embodiment 7 pharmaceutical compositions of the present invention
Get vinegar Concha Arcae 50g, Endoconcha Sepiae 10g after the pulverizing, crosses 200 mesh sieves, take appropriate amount of PEG 6000 as substrate, be heated to molten condition and Uniform Dispersion after, drop in the liquid paraffin preparation cost invention drop pill.
The preparation of embodiment 8 pharmaceutical compositions of the present invention
Get vinegar Concha Arcae 60g, Endoconcha Sepiae 10g after the pulverizing, crosses 80~100 mesh sieves, behind the mix homogeneously, adds suitable quantity of water or refined honey, by general system or mould method for making, preparation cost invention pill.
The screening of embodiment 9 pharmaceutical composition prescription proportionings of the present invention
By investigating pharmaceutical composition of the present invention to the therapeutical effect of patients w ith peptic ulcer disease, utilize the consumption proportion relation of single blind method screening prescription.In the screening process, selected patient all confirms to suffer from gastric ulcer through scope, selects the administration of following proportioning prescription, and the record patient feedback opinion, the results are shown in Table 1.
Gastric Ulcer standard: upper abdomen dull pain, Tun pain or burn the sample pain, alleviate after taking alkalescent medicine, such pain has rhythmicity, how in 1 hour after the meal, to occur, after 1~2 hour, alleviate gradually, acid regurgitation, belch, heartburn, Abdeminal pain generally also can occur, feel sick, the indigestion symptom such as vomiting; The visible niche of upper digestive tract radiography; Endoscopy, can in stomach see circle or oval, the 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 (being the gastric ulcer active stage).
Criterion of cure: epigastrium pain disappears, endoscopy, and visible ulcer surface white fur disappears, becomes red congested cicatrix, and visible pleat is concentrated (being cicatricial phase).
Effective standard: epigastrium pain disappears or alleviates, endoscopy, and the attenuation of tongue film, ulcer is dwindled, the blush that visible mucous epithelium is regenerated around it; Or ulcer surface almost disappears, and few thin coating (being healing stage) is arranged on it.
Table 1 prescription the selection result
Figure BSA00000450492600041
As shown in Table 1:
(1) although Concha Arcae (calcined) and vinegar Concha Arcae belong to the processed product of Concha Arcae, the drug effect behind the use Concha Arcae (calcined) compatibility is not as good as the vinegar Concha Arcae;
When (2) using separately Concha Arcae, Endoconcha Sepiae, not good to the therapeutic effect of gastric ulcer;
(3) when the vinegar Concha Arcae: when Endoconcha Sepiae was 4: 1, compositions without obviously gastric irritation effect, can be brought into play preferably drug effect; At the vinegar Concha Arcae: Endoconcha Sepiae is 5~6: 1 o'clock, and the therapeutic effect of compositions is best, and its pain relieving antacid successful, and clinical symptoms that can the rapid recovery gastric ulcer are effectively treated gastric ulcer.If vinegar Concha Arcae proportioning consumption is high again, namely close to using separately the vinegar Concha Arcae, its therapeutic effect also is similar to independent use vinegar Concha Arcae, and drug effect is not good.
The above results shows: pharmaceutical composition of the present invention is selected specific Concha Arcae processed product (vinegar Concha Arcae) and specific prescription proportioning (vinegar Concha Arcae: Endoconcha Sepiae=4~6: 1) combine, not only reduced the stimulation of Endoconcha Sepiae to stomach, can also the fast treating gastric ulcer, and pain relieving antacid is respond well, especially when the vinegar Concha Arcae: Endoconcha Sepiae=5~6: in the time of 1, drug side effect obviously reduces, and drug effect significantly is better than other prescriptions, and therapeutic effect is best.
Below further prove beneficial effect of the present invention by clinical practice.
Test example 1 medicine of the present invention is to the treatment of gastric ulcer
Gastric Ulcer standard: see embodiment 9.Accept altogether 1200 examples for medical treatment, endoscopy is confirmed as gastric ulcer.
Therapeutic Method: get the capsule that embodiment 1-3 prepares, use separately, treat respectively the patient of total case number about 1/3, the patient takes 3 every day, each 4, half an hour ante cibum warm water delivery service, period in a medicine is avoided eating anything raw or cold, maror.
Criterion of cure: see embodiment 9.Take medicine continuously by Therapeutic Method, treated 10~15 days, cure 1200 examples, account for 100% of total case.
Test example 2 pharmaceutical compositions of the present invention are to the treatment of duodenal ulcer
Duodenal ulcer diagnostic criteria: epigastrium dull pain, causalgia, distending pain or severe pain, also can be only dull pain discomfort when hunger, or rest pain under slight or the moderate xiphoid-process appears, can be alleviated by antacid or feed, early began to occur upper abdominal pain in 1~3 hour after the meal, just alleviate then will continue to lunch as not taking medicine or taking food after, food also must have meal to alleviate in rear 2~4 hours again bitterly.Endoscopy, thick fur and filth can have petechia, sludged blood on it, the obvious congestion and edema of mucosa is rotten to the corn on every side; Or tongue is still thicker, and the mucosal inflammation edema alleviates on every side, and red re-epithelialize (active stage) can appear in ulcer edge.Accept altogether 200 examples for medical treatment, endoscopy is confirmed as duodenal ulcer.
Therapeutic Method: with test example 1.
Criterion of cure: pain disappears, endoscopy, and white fur disappears, and replaces red epithelium and cicatrix; Or the re-epithelialize redness disappears cicatrix color white (being cicatricial phase).Take medicine continuously by Therapeutic Method, treated 7~10 days, cure 200 examples, account for 100% of total case.
Test example 3 pharmaceutical compositions of the present invention are to the treatment of chronic erosive gastritis
Chronic erosive gastritis diagnostic criteria: the indigestion symptoms such as glutted, acid regurgitation, belch, irregularities stomachache occur, massive bleeding from upper digestive tract can occur, hematemesis, melena occur, shock, normal easily recurrence after the stopped bleeding; Endoscopy, visible gastric mucosa congestion and edema, the some lamellar is rotten to the corn, and the multiple ulcer that differs in size, ulcer surface can have the fresh clot that goes out.Accept altogether 150 examples for medical treatment, endoscopy is confirmed as chronic erosive gastritis.
Therapeutic Method: with test example 1.
Criterion of cure: the indigestion symptoms such as acid regurgitation, stomachache disappear, endoscopy, and rotten to the corn without point-like or lamellar, mucosa edema disappears, and gastric mucosa heals.Take medicine continuously by Therapeutic Method, treated 20~30 days, cure 150 examples, account for 100% of total case.
Test example 4 pharmaceutical compositions of the present invention are to the treatment of duodenal erosion
The duodenal erosion diagnostic criteria: endoscopy, the Duodenal Mucosa layer has red pitting, and the depth is different, shallow person and neck of gland section, dark person reaches muscularis mucosae, but does not pass this layer.Accept altogether 160 examples for medical treatment, endoscopy is confirmed as duodenal erosion.
Therapeutic Method: with test example 1.
Criterion of cure: endoscopy, the Duodenal Mucosa healing without pitting, and does not have cicatrix to leave over.Treated 10~15 days, and cured 160 examples, account for 100% of total case.
In sum, pharmaceutical composition of the present invention has no side effect, can effectively treat Stomach duodenum ulcer, duodenal erosion and chronic erosive gastritis, through clinical verification, this pharmaceutical composition can the rapid recovery Upper abdominal pain etc. clinical symptoms, healing time is short, and cure rate provides the new selection of clinical application up to 100% for treatment peptic ulcer, duodenal erosion and chronic erosive gastritis.

Claims (11)

1. pharmaceutical composition for the treatment of peptic ulcer is characterized in that: it is the preparation that the crude drug by following weight proportion is prepared from:
5~6 parts of vinegar Concha Arcaes; 1 part of Endoconcha Sepiae.
2. pharmaceutical composition according to claim 1 is characterized in that: it is the preparation that the crude drug by following weight proportion is prepared from:
5.5 parts of vinegar Concha Arcaes; 1 part of Endoconcha Sepiae.
3. pharmaceutical composition according to claim 1 and 2, it is characterized in that: described preparation is to be active component by the water of the crude drug of raw material medicated vinegar Concha Arcae and Endoconcha Sepiae or crude drug or extractive with organic solvent, adds what pharmaceutically available adjuvant or complementary composition were prepared from.
4. the described pharmaceutical composition of any one according to claim 1~3, it is characterized in that: described preparation is oral formulations.
5. pharmaceutical composition according to claim 4, it is characterized in that: described oral formulations is powder, granule, pill, capsule or tablet.
6. pharmaceutical composition according to claim 4, it is characterized in that: described oral formulations is drop pill.
7. prepare the method for the described pharmaceutical composition of claim 1~6 any one, it is characterized in that: concrete operation step is as follows:
(1) gets 5~6 parts of vinegar Concha Arcaes, 1 part of Endoconcha Sepiae;
(2) vinegar Concha Arcae, Endoconcha Sepiae are pulverized, sieve, add that pharmaceutically available adjuvant or complementary composition are prepared into preparation.
8. the purposes of the described pharmaceutical composition of claim 1~6 any one in the medicine of preparation treatment chronic erosive gastritis.
9. the purposes of the described pharmaceutical composition of claim 1~6 any one in the medicine of preparation treatment gastric ulcer.
10. the purposes of the described pharmaceutical composition of claim 1~6 any one in the medicine of preparation treatment duodenal erosion.
11. the purposes of the described pharmaceutical composition of claim 1~6 any one in the medicine of preparation treatment duodenal ulcer.
CN2011100611336A 2011-03-15 2011-03-15 Pharmaceutical composition for treating peptic ulcer, preparation method and use of pharmaceutical composition Expired - Fee Related CN102145014B (en)

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RU2532492C1 (en) * 2013-01-28 2014-11-10 Государственное бюджетное образовательное учреждение высшего профессионального образования "Воронежская государственная медицинская академия им. Н.Н. Бурденко" Министерства здравоохранения Российской Федерации Method for endoscopic treatment of gastroduodenal ulcers
CN103989955A (en) * 2014-06-16 2014-08-20 成刚桥 Pharmaceutical composition for treating stomach and duodenum ulcer, superficial multiple gastric ulcer and erosive gastric ulcer
CN110624072A (en) * 2019-07-29 2019-12-31 洪光富 A Chinese medicinal composition for treating duodenal ulcer, gastric erosion, gastric perforation, and superficial gastritis, and its preparation method

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