CN103285359B - Medicament for treating functional dyspepsia and preparation method thereof - Google Patents

Abstract

The invention discloses a medicament for treating functional dyspepsia. The medicament comprises an active component and a pharmaceutically acceptable excipient, wherein the active component is prepared from the following crude drugs in percentage by weight: 20-35 percent of purple perilla, 20-25 percent of immature citron fruit, 15-20 percent of zedoray rhizome, 15-20 percent of coptis chinensis and 15-20 percent of dried ginger. The medicament can be granules, capsules, tablets or pills. Through clinical verification, the medicament has the advantages of good symptom improvement, low relapse rate and no obvious toxic or side effect.

Description

A kind of medicine for the treatment of functional dyspepsia and preparation method thereof

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to the Chinese medicine composition that a kind of traditional Chinese medicinal material raw materials medicine is made.

Technical background

Functional dyspepsia refer to there is stomachache, abdominal distention, belch, anorexia, acid regurgitation, one group of symptom such as feel sick, except gastroesophageal reflux, gastroduodenal hepatobiliary and pancreatic diseases, systemic disease and some drugs to undermine digestive tract etc. organic, and a kind of epigastrium syndrome that the cause of disease does not understand.This disease is commonly encountered diseases, frequently-occurring disease clinically, and in gastropathy, proportion is the highest, and the course of disease is long, easily repeatedly.For the research of its cause of disease, think now relevant with enteric nervous system: 1. gastric motility extremely, 2. stomach dirty to some sensation allergy, 3. the mental status unbalance, 4. some inflammatory stimulus cause, 5. part and Helicobacter pylori infection is relevant, 6. central nervous system unify between enteric nervous system, transmit not normal etc.In treatment, the suitable use of modern medicine opinion gastro-kinetic agent (as, domperidone, cisapride etc.), acid inhibitor and gastric mucosa protective agent (as, gastropine, sucralfate, cimetidine, omeprazole, bismuth potassium citrate etc.) and the medicine of anti-Helicobacter pylori infection (as, ornidazole, amoxicillin, gentamycin etc.), but said medicine all exists certain side effect, some drugs has obvious side effect to hepatic and renal function and nervous system, should not take for a long time; The traditional Chinese medical science thinks that this disease disease, at stomach, relates to liver spleen two dirty, belongs to stomach painful abdominal mass category, due to the insufficiency of the spleen stagnation of QI, incoordination between the liver and stomach, deficiency of stomach-Yin or retention of food and drink etc., treatment taking spleen invigorating, soothing the liver, stomach falls as fundamentum, the treatments such as conventional zhishi xiaopi pills.Described zhishi xiaopi pills is ground into carefully by Fructus Aurantii Immaturus 100g, Rhizoma Atractylodis Macrocephalae 60g, Rhizoma Pinelliae Preparatum 60g, Rhizoma Coptidis 100g, Radix Codonopsis 50g, Radix Glycyrrhizae 40g, Poria 40g, Cortex Magnoliae Officinalis 80g, Fructus Hordei Germinatus 40g and Rhizoma Zingiberis 40g, sieve, mix, with water pill, dry making, has relieving distension and oppression, effect of invigorating the spleen and regulating the stomach, be used for the treatment of damp and hot friendship and steam, breast abdomen painful abdominal mass pain.But above-mentioned conventional prescription still exists curative effect undesirable, the especially easy problem repeatedly of symptom after drug withdrawal.

Summary of the invention

Problem to be solved by this invention is to provide a kind of Chinese medicine for the treatment of functional dyspepsia, and after this medical instrument has drug withdrawal, symptom is difficult for remarkable result repeatedly.

The technical scheme that the present invention addresses the above problem is as described below:

Treat a medicine for functional dyspepsia, this medicine is made up of active ingredient and medically acceptable excipient, and wherein said active ingredient is made up of the crude drug of following percentage by weight:

Folium Perillae 20～35%, Fructus Aurantii Immaturus 20～25%, Rhizoma Curcumae 15～20%, Rhizoma Coptidis 15～20% and Rhizoma Zingiberis 15～20%.

Medicine of the present invention, wherein the most preferably proportioning of each crude drug is:

Folium Perillae 25%, Fructus Aurantii Immaturus 25%, Rhizoma Curcumae 17%, Rhizoma Coptidis 17%, Rhizoma Zingiberis 16%.

Medicine of the present invention is oral agents, as granule, capsule, tablet or pill.

Medicine of the present invention can adopt various common preparation methoies to obtain, and wherein a kind of simple and easy to do method is made up of following steps:

(1) according to proportioning weighting raw materials, decoct with water 3 times, add water each time 6～10 times and boil rear intense fire decoction 30～60 minutes;

(2) collecting decoction is concentrated into filtrate density and is 1.20～1.30 clear paste at 65～85 DEG C after filtration, put in baking oven in 70～80 DEG C and bake dry cream, is ground into fine powder;

(3) add appropriate medically acceptable excipient, make according to a conventional method conventional oral agents.

Medicine of the present invention is taking Folium Perillae, Fructus Aurantii Immaturus as monarch drug, and Rhizoma Curcumae is ministerial drug, and Rhizoma Coptidis, Rhizoma Zingiberis are adjuvant.Digestion depends on the transporting of taste, and transporting and transforming function of the spleen and stomach relies its mechanism of qi orderly and clearly entirely, and taste are the hinge of mechanism of qi transporting, if pathogenic factor is invaded and harassed, the most easily stop up stagnant.Therefore taking Folium Perillae, Fructus Aurantii Immaturus as monarch drug is with orderly and clearly mechanism of qi; Qi being the governor of blood, obstruction of QI, blood is easily solidifying puckery, therefore that Rhizoma Curcumae is ministerial drug removing blood stasis with potent drugs is capable stagnant; QI and blood is material base each other, is subordinate to negative and positive, taking Rhizoma Coptidis, Rhizoma Zingiberis as adjuvant is with YIN and YANG balance regulating.Above drug regimen is taking the circulation of qi promoting Eradicates stasis of blood, YIN and YANG balance regulating as main.

Medicine of the present invention can effectively treat functional dyspepsia stomachache, abdominal distention, anorexia, acid regurgitation, belch, etc. cardinal symptom, recurrence is few, and without obvious toxic-side effects.Through the patient's of 2 years multipair 52 routine functional dyspepsias clinical practice, obtain good curative effect, total effective rate is 78.88%.

Medicine of the present invention can further be confirmed by the observation of following clinical case the therapeutic effect of functional dyspepsia.

1, patient profile: select to meet for 2004～2007 years the patient of functional dyspepsia diagnostic criteria, totally 102 examples, wherein male's 54 examples, women's 48 examples; The course of disease 1～12 year, average 5 years; 21～66 years old age, average 41 years old.All patients is accepting all there is western medicines in treatment history before Drug therapy of the present invention, and continuously or discontinuously medicine time all more than 2 months.The decoction of Chinese medicine taking spleen invigorating, soothing the liver, nourishing the stomach as main ingredients, and Chinese patent medicine preparation as zhishi xiaopi pills, lenitive pill etc. be main; Western medicine mostly is gastro-kinetic agent (domperidone, cisapride etc.), presses down acid and gastric mucosa protective agent (gastropine, sucralfate, cimetidine, omeprazole, bismuth potassium citrate etc.) and anti-helicobacter pylori medicine (ornidazole, amoxicillin, gentamycin etc.).Accepting before Drug therapy of the present invention, the symptom of the functional dyspepsia such as all patients all has stomachache, abdominal distention, belch, anorexia, acid regurgitation in various degree, feel sick.

2, case source: all cases is all from No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ outpatient.

3, diagnostic criteria: patient at least 12 weeks occurred symptom in 1 year in the past: 1. continue or repeatability epigastrium middle part pain, discomfort, 2. without the organic disease (comprising scope) that can explain symptom, 3. symptom and defecation have nothing to do.

4, Therapeutic Method:

(1) classified data: by the patient who meets case selection standard according to being divided at random two groups.Treatment group 52 examples, male's 26 examples, women's 24 examples, the course of disease 1～12 year, average 5.1 years; Age 21～～66 years old, average 40.8 years old.Matched group 52 examples, male's 28 examples, women's 24 examples; The course of disease 1～12 year, average 4.9 years; 21～65 years old age, average 41.2 years old.Two groups of cases are learned processing by statistics at aspects such as sex, the course of disease, ages, and there are no significant that meaning (P>0.05) has comparability for difference.

(2) method of administration: treatment group gives the granule of preparing according to the method for embodiment in detailed description of the invention 1, each 1 bag, every day 3 times,

Matched group gives zhishi xiaopi pills (Tonghua Maoxiang Pharmaceutical Co., Ltd., authentication code: the accurate word z22024818 of traditional Chinese medicines), each 6 grams, every day 3 times.

Two groups all taking 1 month as a course for the treatment of, after the course for the treatment of, evaluates its curative effect, and drug withdrawal, after 1 month, is evaluated its long-term efficacy.

5, parameters for observation on effect:

(1) safety is observed: comprise general life index (blood pressure, heart rate, breathing), routine blood test, routine urinalysis, darling renal function inspection and untoward reaction detect.General life index once a day, is told patient method, advises itself and household to be recorded in detail; Other indexs, each inspection once before and after treatment.

(2) observation of curative effect: the improvement situation of cardinal symptom before and after treatment (stomachache, abdominal distention, belch, acid regurgitation, anorexia, feel sick etc.), and drug withdrawal Relapse rate situation after 1 month.

(3) statistical method: measurement data adopts t inspection, and enumeration data adopts x ²inspection, ranked data adopt Ridit inspection.

6, efficacy assessment standard:

(1) clinical cure: cardinal symptom disappears, drug withdrawal is nothing recurrence after 1 month;

(2) effective: cardinal symptom is obviously improved, drug withdrawal is recurrence once in a while after 1 month;

(3) effective: cardinal symptom is improved, and drug withdrawal was recurred after 1 month;

(4) invalid: before and after treatment, cardinal symptom is without improvement.

7, efficacy analysis:

(1) using clinical cure, effective and effectively and the data basis of calculating as total effective rate, treatment group and matched group clinical efficacy relatively in table 1:

Table 1

Group	Case load	Cure	Effective	Effectively	Invalid	Total effective rate
							Treatment group	52	11	21	9	11	78.88%
Matched group	52	6	17	12	17	67.31%

Two groups of clinical comparisons, treatment group total effective rate is 78.88%, matched group is 67.31%, two group of comparison, has significant difference (P<0.05).

(2) treatment group and matched group curative effect improve relatively in table 2:

Table 2

Two groups of clinical comparisons, the equal significant difference of improving number of cases/number for the treatment of precedent (P<0.05) of cardinal symptom.

(3) drug withdrawal is after 1 month, symptom occur number of cases repeatedly and total effectively number of cases (cure, effective and effective number of cases and) percentage ratio as relapse rate, the clinical recurrence rate for the treatment of group and matched group is relatively in table 3:

Table 3

Two groups of clinical comparisons, matched group relapse rate is apparently higher than treatment group, significant difference (P<0.05).

8, interpretation of result:

Table 1, table 2 and table 3 show that medicine of the present invention can more efficiently improve the cardinal symptom of functional dyspepsia, treat generally functional dyspepsia and there is good clinical efficacy, with the comparison of matched group medicine zhishi xiaopi pills, diversity has significant, and relapse rate is low.

In clinical observation process, do not find that this medicine has any bad toxicity, show that this medicine is a safe and effective preparation.

Detailed description of the invention

Embodiment 1(granule):

Get 2500 grams of Folium Perillaes, 2500 grams of Fructus Aurantii Immaturuss, 1700 grams of Rhizoma Curcumae, 1700 grams of Rhizoma Coptidis, 1600 grams of Rhizoma Zingiberiss, implement according to the following steps:

(1) according to proportioning weighting raw materials, decoct with water 3 times, add water for the first time 8 times and boil rear intense fire decoction 30 minutes, add water for the second time 7 times and boil rear intense fire decoction 40 minutes, add water for the third time 6 times and boil rear intense fire decoction 60 minutes;

(2) collecting decoction is concentrated into filtrate density and is 1.30 clear paste at 65 DEG C after filtration, put in baking oven in 70 DEG C and bake dry cream, is ground into fine powder;

(3) in the dry cream fine powder obtaining, add appropriate dextrin and starch to 900g, the granulation that then adds water, dry, granulate, pack, is distributed into 9 grams/bag (containing 3.5 grams/bag, dry medicated powder).

Embodiment 2(granule):

Get 2800 grams of Folium Perillaes, 1500 grams of Fructus Aurantii Immaturuss, 1200 grams of Rhizoma Curcumae, 1200 grams of Rhizoma Coptidis, 1200 grams of Rhizoma Zingiberiss, implement according to the following steps

(1) according to proportioning weighting raw materials, decoct with water 3 times, 9 times are boiled rear intense fire decoction 40 minutes for the first time, and 8 times are boiled rear intense fire decoction 50 minutes for the second time, and 7 times are boiled rear intense fire decoction 60 minutes for the third time;

(2) collecting decoction is concentrated into filtrate density and is 1.25 clear paste at 75 DEG C after filtration, put in baking oven in 75 DEG C

(3) in the dry cream fine powder obtaining, add appropriate dextrin and starch to 900g, the granulation that then adds water, dry, granulate, pack, is distributed into 9 grams/bag (containing 3.5 grams/bag, dry medicated powder).

Embodiment 3(granule):

Get 1500 grams of Folium Perillaes, 2000 grams of Fructus Aurantii Immaturuss, 1500 grams of Rhizoma Curcumae, 1500 grams of Rhizoma Coptidis, 1500 grams of Rhizoma Zingiberiss, implement according to the following steps:

(1) according to proportioning weighting raw materials, decoct with water 3 times, 10 times are boiled rear intense fire decoction 30 minutes for the first time, and 9 times are boiled rear intense fire decoction 50 minutes for the second time, and 8 times are boiled rear intense fire decoction 60 minutes for the third time;

(2) collecting decoction is concentrated into filtrate density and is 1.20 clear paste at 85 DEG C after filtration, put in baking oven in 80 DEG C and bake dry cream, is ground into fine powder;

(3) in the dry cream fine powder obtaining, add appropriate dextrin and starch to 900g, the granulation that then adds water, dry, granulate, pack, is distributed into 9 grams/bag (containing 3.5 grams/bag, dry medicated powder).

Embodiment 4(capsule)

By the drug particles of preparing according to the method for embodiment 1, pack gelatine capsule into, make capsule.

Embodiment 5(tablet):

Embodiment 1 granule is added water moistening, tabletting, the dry tablet that makes.

Embodiment 6(pill):

In the fine powder that step in embodiment 1 (2) obtains, enter appropriate dextrin and starch to 900g, then with water pill, the dry pill that makes.

Claims (4)

1. treat the medicine of functional dyspepsia for one kind, this medicine is made up of active ingredient and medically acceptable excipient, and wherein said active ingredient is made up of the crude drug of following percentage by weight: Folium Perillae 20～35%, Fructus Aurantii Immaturus 20～25%, Rhizoma Curcumae 15～20%, Rhizoma Coptidis 15～20% and Rhizoma Zingiberis 15～20%.

2. a kind of medicine for the treatment of functional dyspepsia according to claim 1, is characterized in that the proportioning of described crude drug is: Folium Perillae 25%, Fructus Aurantii Immaturus 25%, Rhizoma Curcumae 17%, Rhizoma Coptidis 17%, Rhizoma Zingiberis 16%.

3. according to a kind of medicine for the treatment of functional dyspepsia described in claim 1 or 2, it is characterized in that described medicine is granule, capsule, tablet or pill.

4. the preparation method of a kind of medicine for the treatment of functional dyspepsia described in claim 1,2 or 3, the method is made up of following steps:

(1) according to proportioning weighting raw materials, decoct with water 3 times, add water each time 6～10 times and boil rear intense fire decoction 30～60 minutes;

(2) collecting decoction is concentrated into filtrate density and is 1.20～1.30 clear paste at 65～85 DEG C after filtration, put in baking oven in 70～80 DEG C and bake dry cream, is ground into fine powder;

(3) add the acceptable adjuvant of appropriate medical science, make according to a conventional method conventional oral agents.