CN103285326B - Medicine composition for treating gastrointestinal motility disorder - Google Patents

Abstract

The invention relates to a medicine composition for treating gastrointestinal motility disorder. The composition is characterized by comprising the following raw medicines in parts by weight: 10-20 parts of zedoary, 7-15 parts of fructus amomi, 7-15 parts of betel nut, 7-15 parts of costus root and 7-15 parts of spikenard. According to the technical scheme, zedoary, fructus amomi, betel nut, costus root and spikenard are composited on the basis of theory of traditional Chinese medicine and through the adjustment of the lifting motion of spleen and stomach and the synergistic effect on the aspects of promoting qi circulation, resolving dampness, eliminating accumulation, stopping pain and the like, the purposes of promoting gastrointestinal motility and treating gastrointestinal motility disorder are achieved.

Description

A kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to a kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder.

Background technology

Digestive tract power is the important component part of digestive tract physiological function, and its dysfunction is one of deciding factor causing symptom of digestive tract.Digestive tract power is abnormal closely related with the digestive tract complication of multiple digestive system disease and other systemic disease.It by the disease due to gastrointestinal motility disorder, is the commonly encountered diseases of clinical Digestive System Department, the functional dyspepsia that gastrointestinal motility obstacle is cardinal symptom as take accounts for the more than 1/3 of gastrointestinal special outpatient clinic patient, patient's life is had to obvious impact, if add gastritis, the kinetics abnormal diseases that the organic diseases such as ulcer cause, incidence rate is higher.Therefore carry out digestive tract power medicine research important in inhibiting.But, still lacking clinically very effective treatment means, modern medicine also only starts from nearest 20 years to its understanding and research, still has many bases and clinical problem not to be elucidated.In recent years along with to the going deep into of the research of digestive tract power, the extensive use clinically of the medicine for stomach dynamic such as motilium, cisapride, but western medicine curative effect is not good enough at present, and symptom repeatedly, has had a strong impact on patient's work, life.Long-term clinical practice shows that Chinese medicine can be used for the treatment of gastrointestinal motility dysfunction symptom as above distention and fullness in the abdomen, stomachache, belch, poor appetite, constipation etc., good effect and few side effects effectively.

Summary of the invention

The invention provides a kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder, its objective is by optimizing preparation prescription a kind of Chinese medicine preparation in stable curative effect aspect treatment gastrointestinal motility disorder is provided.

For achieving the above object, the technical solution used in the present invention is: a kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder, is comprised of the crude drug of following parts by weight:

Rhizoma Curcumae 10-20 part;

Fructus Amomi 7-15 part;

Semen Arecae 7-15 part;

Radix Aucklandiae 7-15 part;

Radix Et Rhizoma Nardostachyos 7-15 part.

In such scheme, in described pharmaceutical composition each crude drug preferably amount ranges be:

Rhizoma Curcumae 12-18 part;

Fructus Amomi 8-12 part;

Semen Arecae 8-12 part;

Radix Aucklandiae 8-12 part;

Radix Et Rhizoma Nardostachyos 8-12 part.

Therapeutic mechanism of the present invention is: the traditional Chinese medical science thinks that the etiology and pathogenesis of gastrointestinal motility disorder is mostly by dysfunction of spleen and stomach, abnormal ascending-descending of QI, middle burnt stop up stagnant, mechanism of qi retardance, spleen-QI sinking, due to adverse rising of stomach-QI.Pharmaceutical composition of the present invention is from the main pathomechanism incision of gastrointestinal motility disorder, select the medicine of Rhizoma Curcumae, Fructus Amomi, Semen Arecae, the Radix Aucklandiae, Radix Et Rhizoma Nardostachyos five tastes circulation of qi promoting removing dampness sending down the abnormal ascending QI to form, wherein Rhizoma Curcumae is as principal agent, there is the dispelling the stagnated QI long-pending effect that helps digestion, Fructus Amomi, Semen Arecae, the Radix Aucklandiae, Radix Et Rhizoma Nardostachyos are as accessory drugs, there is the effect of removing dampness, circulation of qi promoting spleen invigorating, can strengthen the effect of consumer product dredge stasis, in addition, Radix Et Rhizoma Nardostachyos has also been strengthened the merit of the capable appetizing of faling apart, be amusing of perfect square fragrance, clinical practice also proves better efficacy, and patient's reflection takes effect faster, and compliance is better; All medicines share, and have the effect of invigorating the spleen for eliminating dampness, regulating qi-flowing for activating stagnancy, and its mechanism of action is relevant with the expression that increases digestive tract power and adjusting Duodenal Tissues 5-HT3R.That is to say, technical scheme of the present invention according to theory of Chinese medical science by Rhizoma Curcumae, Fructus Amomi, Semen Arecae, the Radix Aucklandiae, Radix Et Rhizoma Nardostachyos prescription, by function of spleen and stomach regulating elevating movement and at the synergism of the aspects such as circulation of qi promoting, removing dampness, removing food stagnancy, pain relieving, reach the object that promotes digestive tract power, treatment gastrointestinal motility disorder.

In pharmaceutical composition of the present invention, the pharmacology of each Chinese medicine ingredients and the property of medicine are as follows:

Rhizoma Curcumae: pungent, bitter, temperature.Return liver, spleen channel.Removing food stagnancy eliminating stagnation, can circulation of qi promoting removing food stagnancy pain relieving, for eating accumulation, breast abdominal distention is vexed has a pain.There are some researches show, 25% Rhizoma Curcumae water decoction can obviously improve Gastroenteric Electrical arhythmicity and rat stomach Emptying Rate.

Fructus Amomi: acrid in the mouth, warm in nature.Have that removing dampness is amusing, the effect of circulation of qi promoting warming middle-JIAO, < < Compendium of Materia Medica > > records " tonifying the lung is amusing, nourishing the stomach kidney tonifying; reason vigour; dispelling stagnant Qi, dispelling cold fluid-retention and abdominal distension, dysphagic vomiting ".Modern pharmacology is tested and is shown, Fructus Amomi can increase motilin (MTL) level of blood plasma, gastric antrum and jejunum tissue homogenate.

Semen Arecae: property is pungent, warm, bitter in the mouth is nontoxic.Return harmonization of the stomach large intestine channel, have the function of parasite killing, consumer product dredge stasis, promoting the circulation of QI to induce diuresis.Can treat stagnation of QI due to dyspepsia, the diseases such as stomachache distension constipation.How on the books successive dynasties book on Chinese herbal medicine is, < < Newly Revised Canon of Materia Medica > >: " controlling abdominal distention, raw end clothes, the diuretic anus smash ".The bright doctor of < < does not record > >: " rapid digestion of food dewaters, except accumulation of phlegm in the hypochondrium ".< < book on Chinese herbal medicine explicit word > >: " Semen Arecae enter the broken stagnant gas of breast abdomen and do not stop ".< < medication heart method > >: " Semen Arecae, bitter stagnant to break, pungent with the heresy of faling apart, specially broken stagnant gas is descending ".Research in recent years also shows that Semen Arecae has stronger short gastrointestinal motility effect.

The Radix Aucklandiae: return spleen, stomach, liver, lung meridian.Promoting the circulation of QI to relieve pain; Intestinal stasis relieving in tune.The Radix Aucklandiae has the effect of circulation of qi promoting spleen invigorating, and it has the gastric emptying of promotion and intestinal transmission effects, and take enhancing gastric emptying as remarkable.

Radix Et Rhizoma Nardostachyos: acrid in the mouth, sweet, warm in nature; Return spleen, stomach warp; Fragrance row is loose.Radix Et Rhizoma Nardostachyos has warming spleen and stomach for dispelling cold, regulating QI to relieve pain, the effect of the appetizing of being amusing; Radix Et Rhizoma Nardostachyos cures mainly coldness and pain in the epigastrium distension, anorexia, and chest pain, toothache, tumbling down is grieved, beriberi edema, cramp caused by acute vomiting and diarrhea.< < Compendium of Materia Medica > >: " Radix Et Rhizoma Nardostachyos, it is strongly fragrant that fragrance can be opened spleen, adds less in taste medicine the gas of being very amusing ".< < book on Chinese herbal medicine converges says > >: " Radix Et Rhizoma Nardostachyos, the medicine of the smooth stomach of being amusing also." < < opens precious side > > " main sudden attack of pain in the chest and abdomen, the loose full therapeutic method to keep the adverse QI flowing downwards, all gets the meaning that Wen Xianghang is loose.Its gas fragrance, enters in taste medicine, holds up greatly spleen pleasant, the merit of appetite-stimulating indigestion-relieving." < < Japan hanako materia medica > >: " control abdominal distnetion, the therapeutic method to keep the adverse QI flowing downwards." effect of Radix Et Rhizoma Nardostachyos to smooth muscle: giving the forward and backward of Cavia porcellus jet tissue amine, application jatamansi can make bronchiectasis.Alcohol extract is (small intestinal, large intestine, uterus, bronchus) on isolated smooth muscle organ, has the effect of antagonism histamine, 5-hydroxy tryptamine and acetylcholine; The spasm can also antagonism barium chloride causing, therefore still have direct effect to smooth muscle.Clinically with controlling asthma, cough, drop, stomachache etc. may be relevant therewith.

The Pharmacodynamics data of pharmaceutical composition of the present invention:

1, the impact that pharmaceutical composition of the present invention advances gastrointestinal motility disorder rat small intestine due to Radix Glycyrrhizae

Adopt Radix Glycyrrhizae administration by gavage to set up gastrointestinal motility disorder rat model, that from model, sets up starts rats gavaged medicine of the present invention (claiming again stomach moving side) on the 2nd day, the moving side of stomach and the not husky Billy (1.4mg/kg) that continue 3 days gavage heavy doses (10.8g/kg), middle dosage (3.6g/kg), low dose of (1.2g/kg), evaluate the therapeutical effect of the moving side of stomach to gastrointestinal motility disorder rat model by the detection of intestinal propulsion rate.Result shows: the large, medium and small dosage group rat small intestine impelling ratio in the moving side of stomach all has raising in various degree, wherein the stomach heavy dose of group in moving side and middle dosage group are compared and are had significant difference with model group, the difference of comparing with blank group is little, illustrate that there is certain therapeutical effect the moving side of stomach to intestinal motility dysfunction, though but the moving square small dose group rat small intestine impelling ratio of stomach is improved, relatively without significant difference, the moving side of low dose of stomach is not obvious to the improvement effect of intestinal motility obstacle with model group.Generally speaking, the moving intestinal propulsion function that can enough promote gastrointestinal motility disorder rat model due to Radix Glycyrrhizae of stomach.

2, the impact of pharmaceutical composition of the present invention on gastrointestinal motility disorder rat model gut hormone content

What at pharmaceutical composition of the present invention, gastrointestinal motility disorder rat small intestine due to Radix Glycyrrhizae is advanced affects on experiment basis, adopt the method that in blood, gut hormone detects, observe the situation of change of gastrin (GAS), motilin (MTL) and vasoactive peptide (VIP) content, result shows: model group MT in serum L content obviously reduces, and GAS and VIP content obviously raise; The MTL content of the big or middle dosage group in the moving side of stomach obviously raises, and reaches that relatively there were significant differences with model group, and GAS and VIP level reduce degree and model group more also there were significant differences.Though above-mentioned intestinal hormone level has optimum improvement trend in moving square group of low dose of stomach, does not reach significance with model group difference.Illustrate that gastrointestinal motility disorder due to Radix Glycyrrhizae rat model and MTL, GAS and the disorder of VIP secretion level have certain relation, the reduction of MT in serum L content, GAS and VIP increased content may be the reasons of gastrointestinal motility disorder; The moving side of stomach has the optimum improvement effect of gut hormone, its facilitation to digestive tract power, the basis, inherence that may exist gut hormone to change.Therefore, the moving variation that can enough regulate gastrointestinal motility disorder rat model blood GAS, MTL, VIP hormone-content of stomach.

3, the impact of pharmaceutical composition of the present invention on gastrointestinal motility disorder rat preduodenal 5-hydroxy tryptamine (5-HT) content

What at pharmaceutical composition of the present invention, gastrointestinal motility disorder rat small intestine due to Radix Glycyrrhizae is advanced affects on experiment basis, adopt the method for SABC to observe the changes of contents situation of 5-HT in each group rat preduodenal tissue, immunohistochemical staining shows: the EC cell quantity of model group rat preduodenal tissue secretion 5-HT obviously increases, higher than Normal group (P<0.05), after treatment, each dosage group of the moving side of stomach is organized rat preduodenal with not husky Billy and is organized 5-HT content substantially to return to normal level (P>0.05), difference not obvious (P>0.05) between each group of staining power.This experimental result, gastrointestinal motility disorder rat model Duodenal Tissues 5-HT compared with normal rat has the trend increasing, and after stomach moving side treatment, organize 5-HT level can recover to approach normal level, consistent with not husky Billy's therapeutical effect, hints model rat tissue 5-HT level is disorderly, and the moving content that can regulate 5-HT disorderly in gastrointestinal motility disorder rat model Duodenal Tissues of stomach, make it to return to normal level, in conjunction with reported in literature, also illustrate that the moving side of stomach may have dual regulation to 5-HT.

4, the impact of pharmaceutical composition of the present invention on gastrointestinal motility disorder rat preduodenal 5-HT3aR mrna expression

What at pharmaceutical composition of the present invention, gastrointestinal motility disorder rat small intestine due to Radix Glycyrrhizae is advanced affects on experiment basis, application real-time fluorescence quantitative PCR (Real-Time PCR) technology, research 5-HT3aR mRNA is at the in-house expression of gastrointestinal motility disorder rat preduodenal, result shows: compare with blank group, model group rat preduodenal organizes the expression of 5-HT3R to increase, its content is 1.8 times of blank group, through the moving side of stomach and not husky Billy, treat after 3 days, the moving side of stomach is large, in, small dose group and Mo Sha Billy organize rat preduodenal and organize the expression of 5-HT3R all to have reduction in various degree.Therefore, the moving expression that can enough regulate Duodenal Tissues 5-HT3R of stomach.

The specific embodiment

Below in conjunction with embodiment, the invention will be further described:

Embodiment mono-: a kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder

Pharmaceutical composition prescription is comprised of the crude drug of following parts by weight:

Rhizoma Curcumae 15g;

Fructus Amomi 10g;

Semen Arecae 10 g;

The Radix Aucklandiae 10 g;

Radix Et Rhizoma Nardostachyos 10 g.

Embodiment bis-: a kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder

Pharmaceutical composition prescription is comprised of the crude drug of following parts by weight:

Rhizoma Curcumae 10 g;

Fructus Amomi 7 g;

Semen Arecae 7 g;

The Radix Aucklandiae 7 g;

Radix Et Rhizoma Nardostachyos 7 g.

Embodiment tri-: a kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder

Pharmaceutical composition prescription is comprised of the crude drug of following parts by weight:

Rhizoma Curcumae 12 g;

Fructus Amomi 8 g;

Semen Arecae 8 g;

The Radix Aucklandiae 8 g;

Radix Et Rhizoma Nardostachyos 8 g.

Embodiment tetra-: a kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder

Pharmaceutical composition prescription is comprised of the crude drug of following parts by weight:

Rhizoma Curcumae 20 g;

Fructus Amomi 15 g;

Semen Arecae 15 g;

The Radix Aucklandiae 15 g;

Radix Et Rhizoma Nardostachyos 15 g.

Embodiment five: a kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder

Pharmaceutical composition prescription is comprised of the crude drug of following parts by weight:

Rhizoma Curcumae 18 g;

Fructus Amomi 12 g;

Semen Arecae 12 g;

The Radix Aucklandiae 12 g;

Radix Et Rhizoma Nardostachyos 12 g.

Embodiment six: a kind of pharmaceutical composition for the treatment of gastrointestinal motility disorder

Pharmaceutical composition prescription is comprised of the crude drug of following parts by weight:

Rhizoma Curcumae 16 g;

Fructus Amomi 11 g;

Semen Arecae 11 g;

The Radix Aucklandiae 11 g;

Radix Et Rhizoma Nardostachyos 9 g.

Functional dyspepsia is the commonly encountered diseases of digestive system, and clinical manifestation is Abdeminal pain, early full, burn feeling, belch, nausea and vomiting and inenarrable epigastric discomfort sense etc., and its morbidity is relevant with gastrointestinal motility disorder.Western medicine curative effect is not good enough at present, and symptom repeatedly, has had a strong impact on patient's work, life.Applicant adopts pharmaceutical composition prescription of the present invention (claiming again stomach moving side) treatment functional dyspepsia, the clinical curative effect that has obtained satisfaction.

Clinical practice example: after the Chinese medicinal granule of each component of the present invention (Tian Jiang Pharma Inc. provides by Jiangsu) is mixed, by 150 ~ 200ml warm water, be washed into suspension, oral, treatment patients with functional dyspepsia 29 examples, and with 31 examples of taking not husky Billy treatment in contrast, by symptom before and after treatment, serum motilin is when measured, is obtained the moving side's treatment of stomach patients with functional dyspepsia clinical efficacy remarkable, be now reported as follows:

1 data and method

1.1 clinical datas: this is organized 60 routine patients and derives from June, 2012 ~ 2012 Nianl2Yue Wo institute Gastroenterology dept.'s outpatient service and ward, are divided into two groups at random, treatment group man l0 example, female's 19 examples, age 26-64 year, 37 years old mean age; Matched group man 12 examples, female's 19 examples, age 24-63 year, 37.5 years old mean age.All patients all do gastroscope, B ultrasonic, blood, urine, stool routine and biochemical a complete set of inspection.

1.2 enter group standard: all patients meet following 4 conditions: (1) all have epigastrium pain, early full, abdominal distention, belch, feel sick, the indigestion symptom such as acid regurgitation; (2) endoscopy is not found the organic diseases such as peptic ulcer, reflux esophagitis, tumor in upper digestive tract; (3) laboratory, B ultrasonic, the biochemical a complete set of pathological changes of getting rid of the impact digestion such as liver and gall spleen pancreas; (4) without abdominal operation history.The sequencing medical by patient is divided into treatment group and matched group at random.

1.3 Therapeutic Method: the moving side for the treatment of group oral Chinese medicine stomach (15 grams of Rhizoma Curcumae, 10 grams of Fructus Amomis, 10 grams of the raw Radix Aucklandiae, 10 grams of Semen Arecaes, 10 grams of Radix Et Rhizoma Nardostachyos, Tian Jiang Pharma Inc. provides Chinese medicinal granule by Jiangsu); 5mg of the oral mosapride citrate of matched group (the auspicious fine jade of trade name, Haosen Pharmaceutical Co., Ltd., Lianyungang produces), every day three times.Be 4 weeks the course for the treatment of.And look into serum motilin level respectively at blood drawing before and after treatment.

1.4 efficacy assessment standard

Symptom evaluation criteria: asymptomatic is 0 minute; After prompting, can recognize that symptom exists for 1 minute; Symptom exists but do not affect daily life is 2 minutes; It is 3 minutes that symptom affects daily life.

Efficacy evaluation: effective, integration reduces more than 80%; Effectively, integration reduces by 50～80%; Invalid, integration reduces below 50%.

1.5 statistical methods adopt 18.0 editions softwares of SPSS to carry out statistical analysis, and two groups of clinical efficacies are used X ²check, P<0.05 represents that difference has statistical significance.

2 results

2.1 treatments are after 4 weeks, and treatment group curative effect is apparently higher than matched group (P<0.05), shown in l.Treatment group serum motilin level, apparently higher than matched group (P<0.05), is shown in Table 2.

Table 1 treatment two groups of patients with functional dyspepsia symptoms comparison after 4 weeks

Group	Number of cases	Effective number of cases	Obvious effective rate (%)	Total effectively number of cases (%)	Total effective rate (%)
						Treatment group	29	25	86.2*	27	93.1**
Matched group	31	21	67.7	25	80.6

Explanation for table 1 partial content: (1) total effective rate=cure rate+obvious effective rate+effective percentage; (2) * P<0.05, * * P<0.05.

As can be seen from Table 1, the obvious effective rate for the treatment of group and total effective rate be all higher than matched group, and have significance (P<0.05), and treatment group curative effect is apparently higher than matched group.

Table 2 treatment two groups of patients with functional dyspepsia serum motilins comparison after 4 weeks

Group	Number of cases	Before treatment (ng/L)	After treatment (ng/L)
				Treatment group	29	196.00±26.25	296.40±23.30*
Matched group	31	201.01±30.43	235.30±29.24

Explanation for table 2 partial content: * P<0.05.

As can be seen from Table 2, after treatment, treatment group serum motilin level, apparently higher than matched group, and has significance (P<0.05).

2.2 untoward reaction

Two groups of patient's untoward reaction are slight.Treatment group times of defecation increases by 2 examples, borborygmus 1 example, and adverse reaction rate is 10.3%; Matched group times of defecation increases by 2 examples, and borborygmus 2 examples adhere to that through explaining medication, symptom spontaneous remission, adverse reaction rate are 12.9%.Two groups of difference nonsignificances (P>0.05).

3 discuss

Functional dyspepsia is the clinical common syndrome of digestive system, cause and onset of disease mechanism is illustrated so far not yet completely, it is generally acknowledged that affecting the daily life factor that gastrointestinal function brings out functional dyspepsia symptom generally includes three aspects: the one, and the distress of psychology and spirit; The 2nd, Bad Eating Habit, comprise irritable food and Bad Eating Habit; The 3rd, the impact of ambient temperature.Various paathogenic factors are all finally cause gastrointestinal motility disorder and occur indigestion symptom.Uncomfortable and impact that may be on quality of life that the harm that functional dyspepsia brings to patient is mainly manifested in that digestive symptoms causes.Some patients were finally causes becoming thin.

Motilin, by gastrointestinal mucosa Mo emiocytosis, is distributed in small intestinal.Research in recent years points out, the generation of dividing a word with a hyphen at the end of a line property myoelectricity complex wave (MMC) and divide a word with a hyphen at the end of a line and be mainly subject to the adjusting of enteric nervous system and gut hormone.The generation of MMC is be released into blood in a large number and caused by the motilin that is periodically-varied.So whether detection functionality dyspepsia patient plasma motilin can indirectly observe MMC and lacks, for clinical observation on the therapeutic effect provides important objective basis.

This research is by clinical efficacy and serum motilin in conjunction with observation, and finding that Chinese medicine stomach is moving can obviously improve the curative effect to patients with functional dyspepsia, and after testing serum motilin level also more not husky Billy's treatment group is high, proportional with curative effect.The moving side of visible Chinese medicine stomach can promote digestive tract power by improving serum motilin level, and due to many target spots regulating action of Chinese medicine, clinical efficacy is better than urging merely digestive tract power treatment.

Above-described embodiment is only explanation technical conceive of the present invention and feature, and its object is to allow person skilled in the art can understand content of the present invention and implement according to this, can not limit the scope of the invention with this.All equivalences that spirit is done according to the present invention change or modify, within all should being encompassed in protection scope of the present invention.

Claims (2)

1. a pharmaceutical composition for the treatment of gastrointestinal motility disorder, is characterized in that: the crude drug by following parts by weight forms:

Rhizoma Curcumae 10-20 part;

Fructus Amomi 7-15 part;

Semen Arecae 7-15 part;

Radix Aucklandiae 7-15 part;

Radix Et Rhizoma Nardostachyos 7-15 part.

2. the pharmaceutical composition for the treatment of gastrointestinal motility disorder according to claim 1, is characterized in that: the crude drug by following parts by weight forms:

Rhizoma Curcumae 12-18 part;

Fructus Amomi 8-12 part;

Semen Arecae 8-12 part;

Radix Aucklandiae 8-12 part;

Radix Et Rhizoma Nardostachyos 8-12 part.