CN104606376A - Traditional Chinese medicinal composition preparation for treating gastric ulcer and preparation method thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicinal composition preparation for treating gastric ulcer and a preparation method thereof. Raw materials of the traditional Chinese medicinal composition preparation consist of the following Chinese medicinal components in parts by weight: 20 to 50 parts of zanthoxylum nitidum, 20 to 40 parts of scandent schefflera root, 10 to 30 parts of centipeda minima, 10 to 30 parts of bigleaf beautyberry leaf, 8 to 20 parts of white paeony root, 5 to 15 parts of rhizoma corydalis and 5 to 15 parts of liquorice. The traditional Chinese medicinal composition preparation has effects of regulating stomach and removing painful abdominal mass, warming middle-jiao to dispel cold, invigorating the spleen to eliminate dampness, activating blood and dissolving stasis and promoting qi circulation to relieve pain and can obviously improve gastric ulcer symptoms of patients, such as epigastrium nausea, pain, belching, xerostomia, epigastric upset, acid regurgitation and the like. The preparation is scientific and reasonable in production process, is convenient to take, has small side effects and has no adverse reaction.

Description

A kind of Chinese medicinal composition preparation for the treatment of gastric ulcer and preparation method thereof

Technical field

The invention belongs to medicine field, relate to a kind of Chinese medicinal composition preparation for the treatment of gastric ulcer and preparation method thereof.

Background technology

Modern owing to being busy with one's work, often staying up late, at ordinary times diet not note etc. reason causing the health of a lot of people to be all in sub-health state, as gastric ulcer.Gastric ulcer is common clinical, frequently-occurring disease, its etiology and pathogenesis is illustrated so far not yet completely, modern medicine is illustrated not yet about the cause of disease of gastric ulcer, think that its basic pathogenesis is peracid, helicobacter pylori, it is unbalance that immunity waits many factors to cause stomach to bore between the infringement of film and protection factor, based on symptomatic treatment in treatment, comprise antacid, anti-HP, strengthen mucous membrane protection, promote gastric peristalsis, reduce the hands sections such as Duodenal reflux, along with the appearance of various efficient antacid new drug, treatment gastric ulcer obtains good curative effect, but relapse rate still can be in any more, and majority has the medicine of definite curative effect, long-term taking has again many untoward reaction, so anxious to be developed go out one can ensure curative effect, relapse rate can be reduced again, and the medicine that untoward reaction is slight.Chinese medicine gastric ulcer few side effects, not easily produces drug resistance, treating both the principal and secondary aspects of a disease, has unique advantage and potential.The present invention, through long term accumulation, works out a kind of Chinese medicinal composition preparation for the treatment of gastric ulcer, effectively can improve symptom, can reduce recurrence again, at present, there is not yet relevant report.

(1) Radix Zanthoxyli is the dry root of rutaceae Radix Zanthoxyli Zanthor μ lum nitidum (Roxb.) DC..Record in Chinese Pharmacopoeia version in 2010: [nature and flavor with return through] are bitter, pungent, flat; Slightly poisonous.Return liver, stomach warp.[function with cure mainly] blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain, dispelling wind and removing obstruction in the collateral, removing toxic substances and promoting subsidence of swelling.For injury from falling down, stomachache, toothache, rheumatic arthralgia, venom; Externally treating burns and scalds.Modern study shows, the two sides crown is mainly containing containing the chemical compositions such as alkaloid, diosmin, coumarin, sterin, flavonoid glycoside, aminoacid.Radix Zanthoxyli Chinese medicine extract antiinflammatory, analgesia, anti-mattress, to cardiovascular system, spasmolytic, anticancer etc. in all have effect.

(2) Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae), is Araliaceae Schefflera plant schefflera arboricola Scheffleva arboricola Hayata and Schefflera venulosa (Wight et Arn.) Harms S.venulosa (Wight et Arn.) Harms, is used as medicine with stem and leaf.Record in Chinese Pharmacopoeia version in 1977: [nature and flavor] acrid in the mouth; Micro-hardship; Warm in nature.[function with cure mainly] wind-expelling pain-stopping; Promoting blood circulation and detumescence.Main air pain of dampness syndrome; Headache; Toothache; Epigastric pain; Dysmenorrhea; Puerperal abdonimal pain; Treating swelling and pain by traumatic injury; Fracture; Skin ulcer swells.

(3) Herba Centipedae is the dry herb of feverfew Herba Centipedae Centipeda minima (L.) A.Br.et Aschers..Record in Chinese Pharmacopoeia version in 2010: [nature and flavor with return through] are pungent, temperature.Return lung meridian.[function with cure mainly] dispersing wind-cold, clearing the nasal passage, cough-relieving.For headche due to wind-cold, cough with copious phlegm, has a stuffy nose obstructed, nasal sinusitis watery nasal discharge.

(4) Folium Callicarpae Macrophyllae is dried leaves or the band leaf twig of Verbenaceae Folium Callicarpae Macrophyllae Callicarpa macroph μ llaVahl.Record in Chinese Pharmacopoeia version in 2010: [nature and flavor with return through] are pungent, bitter, flat.Return liver, lung, stomach warp.[function with cure mainly] dissipating blood stasis stops blooding, reducing swelling and alleviating pain.For epistaxis, spitting of blood, spits blood, has blood in stool, traumatic hemorrhage, tumbling and swelling.

(5) Radix Paeoniae Alba, the dry root of ranunculaceae plant Radix Paeoniae Paeonia tacti lora Pall..[nature and flavor with return through] are bitter, sour, are slightly cold.Return liver, spleen channel.[function with cure mainly] nourishing blood for regulating menstruation, astringing YIN to stop sweating, easing the affected liver to relieve pain, suppressing liver-YANG.For blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, stomachache, limb pain twin, has a headache dizzy.

(6) Rhizoma Corydalis is the dry tuber of papaveraceae plant corydalis Corydalis yanhusuo W.T.Wang.Record in Chinese Pharmacopoeia version in 2010: [nature and flavor with return through] are pungent, bitter, temperature.Return liver, spleen channel.[function with cure mainly] invigorates blood circulation, circulation of qi promoting, pain relieving.For the breast side of body, epigastric pain, obstruction of qi in the chest and cardialgia, amenorrhea dysmenorrhea, postpartum stagnation, tumbling and swelling.

(7) Radix Glycyrrhizae is the dry root and rhizome of glycyrrhizic legume Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. Glycyrrhizainflata Bat. or Glycyrrhiza glabra L. Glycyrrhiza glabra L..[nature and flavor with return through] are sweet, flat, GUIXIN, lung, spleen, stomach warp; [function with cure mainly] invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription, for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.

Summary of the invention

The object of this invention is to provide a kind of Chinese medicinal composition preparation for the treatment of gastric ulcer.

The technical solution adopted in the present invention is as follows:

Treat a Chinese medicinal composition preparation for gastric ulcer, raw material is made up of the Chinese medicinal components of following weight portion: Radix Zanthoxyli 20-50 part, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae) 20-40 part, Herba Centipedae 10-30 part, Folium Callicarpae Macrophyllae 10-30 part, Radix Paeoniae Alba 8-20 part, Rhizoma Corydalis 5-15 part, Radix Glycyrrhizae 5-15 part.

The Chinese medicinal composition preparation of the above treatment gastric ulcer, raw material is preferably made up of the Chinese medicinal components of following weight portion: Radix Zanthoxyli 35 parts, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae) 30 parts, Herba Centipedae 20 parts, Folium Callicarpae Macrophyllae 20 parts, the Radix Paeoniae Alba 15 parts, Rhizoma Corydalis 10 parts, 10 parts, Radix Glycyrrhizae.

The Chinese medicinal composition preparation of the above treatment gastric ulcer, acceptable excipient on various pharmaceuticss required when preparing different dosage form can be added, as disintegrating agent, lubricant, binding agent, cosolvent, thickening agent, antiseptic etc., and be prepared into pharmaceutically acceptable any dosage form with modern Chinese medicine formulation method.Such as, be mixed and made into powder after each raw material of Chinese medicine directly can being pulverized; Also by these crude drug water or with processing accordingly after ethanol extraction and adding the different auxiliary material needed for the different solid preparation of preparation, the day oral solid preparation that capsule, tablet, pill, powder, drop pill, granule etc. are multi-form can namely be can be made into; Also by these crude drug water or with processing accordingly after ethanol extraction and adding the different auxiliary material prepared needed for different liquids preparation, the oral liquid that mixture, syrup, Emulsion etc. are multi-form can namely be can be made into.As preferably, described dosage form is tablet.

The preparation method of the Chinese medicinal composition preparation of the above treatment gastric ulcer, comprises the following steps:

1. take component respectively by weight: Radix Zanthoxyli 20-50 part, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae) 20-40 part, Herba Centipedae 10-30 part, Folium Callicarpae Macrophyllae 10-30 part, Radix Paeoniae Alba 8-20 part, Rhizoma Corydalis 5-15 part, Radix Glycyrrhizae 5-15 part;

2. get Rhizoma Corydalis and be ground into fine powder, cross 80 mesh sieves, obtain first English white;

3. get Herba Centipedae and extract volatile oil, for subsequent use; Medicinal residues and Radix Zanthoxyli, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae), Folium Callicarpae Macrophyllae, the Radix Paeoniae Alba, Radix Glycyrrhizae, add 6-10 times of water gaging, heating extraction 2-3 time, each 1-2 hour, filter, merging filtrate, filtrate is condensed into thick paste, adds the first English white under step 2 and appropriate amount of starch, dry, pulverize, get dry extract powder;

4. get the volatile oil under step 3, with 6-10 times amount betacyclodextrin inclusion his cyclodextrin inclusion complex at double, add in step 3 dried cream powder, then add carboxymethylstach sodium, hyprolose, mixing, makes granule, dry, obtains dry granule;

5. in dry granule, add magnesium stearate, mixing, tabletting, to obtain final product.

Chinese medicine composition of the present invention is made up of Radix Zanthoxyli, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae), Herba Centipedae, Folium Callicarpae Macrophyllae, the Radix Paeoniae Alba, Rhizoma Corydalis, Radix Glycyrrhizae, all medicines are harmonious, gather altogether and diabetes involving middle-JIAO painful abdominal mass, warming spleen and stomach for dispelling cold, the spleen strengthening and damp drying, blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain merit, there is well treatment gastric ulcer effect.The consumption of pharmaceutical composition of the present invention is also through inventor and gropes in a large number to sum up, repeatedly study and verify preferably and obtain, and this preparation production technique is scientific and reasonable, is suitable for the large production of industry.Show through clinical trial: the present invention treats gastric ulcer significant curative effect, effective percentage reaches 98%, can obviously improve patient's epigastrium full vexed, pain, belch, xerostomia, noisy, pantothenic acid, weak, become thin, the symptom such as lack of appetite, and side effect is little, during medication, there is not the untoward reaction such as gastrointestinal tract, allergy.

Detailed description of the invention

Below in conjunction with specific embodiment, the invention will be further described, but do not limit the scope of the invention and range of application:

One, the preparation method of the Chinese medicinal composition preparation of gastric ulcer is treated

1. EXPERIMENTAL DESIGN:

This test 5 embodiments are prepared into tablet respectively, and design parameter refers to table 1.

Table 1 embodiment preparation parameter table

Embodiment	Embodiment 1	Embodiment 2	Embodiment 3	Embodiment 4	Embodiment 5
						Radix Zanthoxyli (kg)	20	50	40	30	35
Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae) (kg)	20	40	35	25	30
						Herba Centipedae (kg)	10	30	25	15	20
Folium Callicarpae Macrophyllae (kg)	10	30	25	15	20
						The Radix Paeoniae Alba (kg)	8	20	18	10	15
Rhizoma Corydalis (kg)	5	15	12	8	10
						Radix Glycyrrhizae (kg)	5	15	12	8	10
Extract amount of water (doubly)	6	8	10	7	8
						Extraction time (secondary)	3	2	2	3	2
Time (h/ time)	1	2	1.5	1	2
						Relative density (60 DEG C)	1.25	1.28	1.26	1.32	1.30
Betacyclodextrin amount (doubly)	6	8	7	8	6

2. operating procedure:

(1) take respectively by table 1 weight portion: Radix Zanthoxyli, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae), Herba Centipedae, Folium Callicarpae Macrophyllae, the Radix Paeoniae Alba, Rhizoma Corydalis, Radix Glycyrrhizae;

(2) get Rhizoma Corydalis and be ground into fine powder, cross 80 mesh sieves, obtain first English white;

(3) get Herba Centipedae and extract volatile oil, for subsequent use; Medicinal residues and Radix Zanthoxyli, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae), Folium Callicarpae Macrophyllae, the Radix Paeoniae Alba, Radix Glycyrrhizae, add 6-10 times of water gaging, heating extraction 2-3 time, each 1-2 hour, filters, merging filtrate, filtrate is condensed into the thick paste that relative density is 1.25 ~ 1.32 (60 DEG C), adds the first English white under step (2) and appropriate amount of starch, dry, pulverize, get dry extract powder;

(4) get the volatile oil under step (3), with 6-10 times amount betacyclodextrin inclusion his cyclodextrin inclusion complex at double, add in step (3) dried cream powder, add carboxymethylstach sodium, hyprolose again, mixing, makes granule, drying, obtains dry granule;

(5) in dry granule, add magnesium stearate, mixing, tabletting, to obtain final product.

Three, clinical practice

1. case selection standard

All cases all meet the diagnostic criteria that digestive endoscopy branch of Chinese Medical Association works out " the endoscopic classification grade scale of chronic gastritis and the tentative suggestion for the treatment of " in 2003.

(1) clinical cardinal symptom: the epigastrium of prolonged and repeated generation full vexed, pain, belch, xerostomia, noisy, pantothenic acid.Have a medical check-up and can have the mild tenderness of epigastrium, without muscle tonus and rebound tenderness.

(2) gastroscope prompting has shallow gastric ulcer or erosive gastric ulcer or reflux gastric ulcer.

(3) inclusive criteria:

A. the age is between 18-65 year.

B. before medication, 1-2 week is interior through gastroscope, pathologic finding prover.

C. can partner treatment, the patient of further consultation on time.

(4) exclusion standard

A. the age is under-18s or over-65s person.

B. peptic ulcer is merged, digestive system carcinoma, the doubtful person of cancerating of pathological diagnosis.

C. severe primary disease, the abdominal operations such as Progressive symmetric erythrokeratodermia scleroderma, the heart, cerebrovascular, Liver and kidney and hemopoietic system is merged, psychotic.

D. gestation or preparation gravid woman, women breast-feeding their children.

E. allergic constitution or to multi-medicament allergy sufferers.

F. not by regulation medication or therapy discontinued, cannot judge that curative effect or data are not congruent and affect the treatment or safety judgement person.

2. therapeutic scheme

(1) embodiment group: by above-mentioned embodiment 5 sample prepared, for clinical trial.Oral, one time 5,3 times on the one.The course for the treatment of: medication 45 days.

(2) matched group: cubic stomach sheet (commercially available).Oral, one time 3,3 times on the one.The course for the treatment of: medication 45 days.

3. efficacy assessment standard

Integration × 100% before therapeutic index=(treat front integration one and treat rear integration)/treatment

(1) fully recover: clinical cardinal symptom disappears or substantially disappears, therapeutic index >=95%; Gastroscopy ulcer and around inflammation all disappear, and are cicatrix.

(2) improve: clinical cardinal symptom take a favorable turn, therapeutic index >=30%; Gastroscopy ulcer surface reduces more than 50%.

(3) invalid: clinical cardinal symptom without improvement, therapeutic index < 30%; Gastroscopy ulcer surface reduces not as good as 50%.

4. result of the test: be used for the treatment of and observe 75 routine outpatients.By above-mentioned embodiment 5 sample for preparing and cubic stomach sheet, be respectively used to patient: treatment group: 45 examples (man 22 example, female 23 example, 38.5 years old mean age), matched group 30 example (man 13 example, female 17 example, 40.2 years old mean age), the results detailed in Table 2.

Table 2 clinical trial result table

Result shows: adopt the embodiment of the present invention 5 to treat, cure rate is 76%, effective percentage reaches 98%, general effect is suitable with matched group, do not have untoward reaction to occur, use safety, effectively, can obviously improve patient's epigastrium full vexed, pain, belch, xerostomia, noisy, pantothenic acid, weak, become thin, the symptom such as lack of appetite, favourable prognosis, without recurrence.Be below several model case:

Case 1: multitude's ××, man, 28 years old, before or after meals stomach dull pain, existing half a year, hospital gastroscope check result: shallow gastric ulcer.Take the embodiment of the present invention 5, each 5, every day 3 times, serve on 45, gastric ulcer transference cure, recovery from illness.Pay a return visit after 1 year, have no recurrence.

Case 2: Tang's ××, female, 45 years old, epigastrium was glutted, dull pain, belch acid regurgitation.Gastroscopy gastric mucosa is congested.Take the embodiment of the present invention 5, each 5, every day 3 times, take 5, dull pain symptom is eliminated, and take 10, glutted, belch acid regurgitation symptom is obviously improved, and serve on 45, gastric ulcer transference cure, recovery from illness.Pay a return visit after 1 year, have no recurrence.

Case 3: Song's ××, man, 38 years old, has chronic alcoholism history, easily has a stomachache on an empty stomach, time have sense of feeling sick.Gastroscopy, gastric mucosa is congested, ulcer.Take the embodiment of the present invention 5, each 5, every day 3 times, serve on 45, above symptom is eliminated, gastroscopy, has no stomach congested and rotten to the corn, recovery from illness.Pay a return visit after 1 year, have no recurrence.

Claims (2)

1. treat the Chinese medicinal composition preparation of gastric ulcer for one kind, it is characterized in that, raw material is made up of the Chinese medicinal components of following weight portion: Radix Zanthoxyli 20-50 part, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae) 20-40 part, Herba Centipedae 10-30 part, Folium Callicarpae Macrophyllae 10-30 part, Radix Paeoniae Alba 8-20 part, Rhizoma Corydalis 5-15 part, Radix Glycyrrhizae 5-15 part.

2. treat a preparation method for the Chinese medicinal composition preparation of gastric ulcer as claimed in claim 1, it is characterized in that, comprise the following steps:

(1) component is taken respectively by weight: Radix Zanthoxyli 20-50 part, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae) 20-40 part, Herba Centipedae 10-30 part, Folium Callicarpae Macrophyllae 10-30 part, Radix Paeoniae Alba 8-20 part, Rhizoma Corydalis 5-15 part, Radix Glycyrrhizae 5-15 part;

(2) get Rhizoma Corydalis and be ground into fine powder, cross 80 mesh sieves, obtain first English white;

(3) get Herba Centipedae and extract volatile oil, for subsequent use; Medicinal residues and Radix Zanthoxyli, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae), Folium Callicarpae Macrophyllae, the Radix Paeoniae Alba, Radix Glycyrrhizae, add 6-10 times of water gaging, heating extraction 2-3 time, each 1-2 hour, filter, merging filtrate, filtrate is condensed into thick paste, adds the first English white under step (2) and appropriate amount of starch, dry, pulverize, get dry extract powder;

(4) get the volatile oil under step (3), with 6-10 times amount betacyclodextrin inclusion his cyclodextrin inclusion complex at double, add in step (3) dried cream powder, then add carboxymethylstach sodium, hyprolose, mixing, makes granule, dry, obtains dry granule;

(5) in dry granule, add magnesium stearate, mixing, tabletting, to obtain final product.