CN102274448B - Pharmaceutical composition for treating spleen deficiency and qi stagnation type functional dyspepsia and preparation method - Google Patents
Pharmaceutical composition for treating spleen deficiency and qi stagnation type functional dyspepsia and preparation method Download PDFInfo
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Abstract
The invention provides a pharmaceutical composition for treating spleen deficiency and qi stagnation type functional dyspepsia and a preparation method thereof. The pharmaceutical composition contains pilose Asiabell root, stir-fried largehead atractylodes rhizome, Indian buead, roasted liquoric root, stir-baked officinal magnolia bark with ginger juice, costustoot, villous amomum fruit, stir-baked rhizoma corydalis with vinegar and prepared pinellia tuber, preferentially, the pharmaceutical composition contains 15 parts by weight of the pilose Asiabell root, 10 parts by weight of the stir-fried largehead atractylodes rhizome, 10 parts by weight of the Indian buead, 5 parts by weight of the roasted liquoric root, 10 parts by weight of the stir-baked officinal magnolia bark with the gingerjuice, 10 parts by weight of costustoot, 6 parts by weight of the villous amomum fruit, 15 parts by weight of the stir-baked rhizoma corydalis with the vinegar and 10 parts by weight of the prepared pinellia tuber. The composition can overcome the defects of indefinite cause of the disease, indefinite nosogenesis and only symptomatic treatment of existing pharmaceutical preparations for treating the functional dyspepsia, is used for treating the functional dyspepsia based on syndromes spleen deficiency and qi stagnation and is further safe, effective, low in cost and convenient to grasp.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of functional dyspepsia, particularly relate to a kind for the treatment of based on pharmaceutical composition of the functional dyspepsia of syndrome of spleen-deficiency and QI-stagnation and its preparation method and application.
Background technology
Functional dyspepsia (functional dyspepsia, FD) be one group of glutted after persistence or repeatability outbreak epigastrium pain, the food, abdominal part flatulence, belch, early full, anorexia, the epigastric discomfort such as feel sick are the clinical syndrome of cardinal symptom, function of dominant gastroenteropathy category.The prevalence of various countries' report accounts for 20～40% of Gastroenterology Clinic in China with the indigestion symptom clients between 20～49%, the functional dyspepsia sickness rate is further ascendant trend in China, is the study hotspot in the sick field of digestion always.
For functional dyspepsia, the predicament that western medicine faces is: 1. pathogenesis is illustrated not yet fully: may relate to the many factors such as sensitivity, inflammation, HP infection of dyskinesis, internal organs, so think that functional dyspepsia is that the gastrointestinal motility disorder that participates in of multiple physiology and social factor is diseases related.2. lack the treatment of specially good effect, the state of an illness expends a large amount of medical resources easily repeatedly.Western medicine mainly is the utilization of short digestive tract power, protection gastric mucosa medicine and antisecretory at present, and to using the anti-depression anxiety medicine with the psychological abnormality person, curative effect is far from satisfactory, and easily repeatedly, lacks the individuation diagnosis and treatment scheme for multi-pathogenesis.
Summary of the invention
Technical problem to be solved by this invention is to overcome the dyspeptic pharmaceutical preparation cause of disease of existing capability and pathogenesis is indefinite and the defective of symptomatic treatment only, a kind of employing Chinese medicine is provided, passes through to regulate the liver spleen, treatment is based on pharmaceutical composition of the functional dyspepsia of syndrome of spleen-deficiency and QI-stagnation and preparation method thereof, and said composition is safe and effective, with low cost, be convenient to grasp.
For solving the problems of the technologies described above, the present invention adopts Radix Codonopsis, Rhizoma Atractylodis Macrocephalae (parched), Poria, Radix Glycyrrhizae Preparata, Cortex Magnoliae Officinalis(processed with ginger), the Radix Aucklandiae, Fructus Amomi, stir-baked RHIZOMA CORYDALIS with vinegar and Rhizoma Pinelliae Preparatum to make pharmaceutical composition, at the treatment functional dyspepsia, especially the functional dyspepsia aspect based on syndrome of spleen-deficiency and QI-stagnation has obtained beyond thought beneficial effect evident in efficacy.
Particularly, the technical solution used in the present invention is, a kind of pharmaceutical composition for the treatment of functional dyspepsia is provided, and it is characterized in that, contains Radix Codonopsis, Rhizoma Atractylodis Macrocephalae (parched), Poria, Radix Glycyrrhizae Preparata, Cortex Magnoliae Officinalis(processed with ginger), the Radix Aucklandiae, Fructus Amomi, stir-baked RHIZOMA CORYDALIS with vinegar and Rhizoma Pinelliae Preparatum.
The present invention also provides a kind of pharmaceutical composition for the treatment of the syndrome of spleen-deficiency and QI-stagnation functional dyspepsia, contains Radix Codonopsis, Rhizoma Atractylodis Macrocephalae (parched), Poria, Radix Glycyrrhizae Preparata, Cortex Magnoliae Officinalis(processed with ginger), the Radix Aucklandiae, Fructus Amomi, stir-baked RHIZOMA CORYDALIS with vinegar and Rhizoma Pinelliae Preparatum.
The pharmaceutical composition of aforesaid treatment functional dyspepsia calculates by weight, contains Radix Codonopsis 5-30, Rhizoma Atractylodis Macrocephalae (parched) 5-20, Poria 5-20, Radix Glycyrrhizae Preparata 2-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Radix Aucklandiae 5-20, Fructus Amomi 1-10, stir-baked RHIZOMA CORYDALIS with vinegar 5-30 and Rhizoma Pinelliae Preparatum 3-10.
The pharmaceutical composition of aforesaid treatment functional dyspepsia calculates by weight, contains Radix Codonopsis 15, Rhizoma Atractylodis Macrocephalae (parched) 10, Poria 10, Radix Glycyrrhizae Preparata 5, Cortex Magnoliae Officinalis(processed with ginger) 10, the Radix Aucklandiae 10, Fructus Amomi 6, stir-baked RHIZOMA CORYDALIS with vinegar 15 and Rhizoma Pinelliae Preparatum 10.
The present invention further provides a kind of preparation of being made by the pharmaceutical composition of above-mentioned treatment functional dyspepsia, the dosage form of said preparation is: decoction or granule.
A kind of method for preparing decoction, calculate by weight, Radix Codonopsis 5-30, Rhizoma Atractylodis Macrocephalae (parched) 5-20, Poria 5-20, Radix Glycyrrhizae Preparata 2-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Radix Aucklandiae 5-20, Fructus Amomi 1-10, stir-baked RHIZOMA CORYDALIS with vinegar 5-30 and Rhizoma Pinelliae Preparatum 3-10 are mixed, this medicinal mixture is soaked, institute's water consumption is for surpassing the medicinal mixture powder more than 1/3, soak time is 20-30 minute, boil with big fire after soaking, then the slow fire decoction is 150-300ml to remaining medicinal liquid, preferred 200ml, repeat above-mentioned decoction process secondary, the gained medicine juice is mixed.
A kind of method for preparing granule, calculate by weight, prepare medicinal granule according to Radix Codonopsis 5-30, Rhizoma Atractylodis Macrocephalae (parched) 5-20, Poria 5-20, Radix Glycyrrhizae Preparata 2-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Radix Aucklandiae 5-20, Fructus Amomi 1-10, stir-baked RHIZOMA CORYDALIS with vinegar 5-30 and Rhizoma Pinelliae Preparatum 3-10, with above-mentioned nine kinds of medicine granule for treating mixings, use the 300ml dissolved in boiled water, then separately for subsequent use according to every part of 150ml.
Wherein, each medical material of Radix Codonopsis, Rhizoma Atractylodis Macrocephalae (parched), Poria, Radix Glycyrrhizae Preparata, Cortex Magnoliae Officinalis(processed with ginger), the Radix Aucklandiae, Fructus Amomi, stir-baked RHIZOMA CORYDALIS with vinegar and Rhizoma Pinelliae Preparatum and their granular preparation all can be commercially available from the market.
Aforesaid preparation method is calculated by weight, uses Radix Codonopsis 15, Rhizoma Atractylodis Macrocephalae (parched) 10, Poria 10, Radix Glycyrrhizae Preparata 5, Cortex Magnoliae Officinalis(processed with ginger) 10, the Radix Aucklandiae 10, Fructus Amomi 6, stir-baked RHIZOMA CORYDALIS with vinegar 15 and Rhizoma Pinelliae Preparatum 10.
Pharmaceutical composition of the present invention is mainly used in treating functional dyspepsia, especially based on the functional dyspepsia of syndrome of spleen-deficiency and QI-stagnation.
Pharmaceutical composition of the present invention is by regulating the liver spleen, to treating functional dyspepsia, especially having obtained good effect based on the functional dyspepsia of syndrome of spleen-deficiency and QI-stagnation, can obviously improve the symptoms such as fullness and oppression in the stomach, epigastric distending pain, lack of appetite be indigestion and loss of appetite, and can improve gastric motility, solved the Western medicine cause of disease and pathogenesis is indefinite, the defective of symptomatic treatment only.
In addition, pharmaceutical composition of the present invention is with low cost, and used medicine all is common Chinese medicine, and administering mode is easy, therefore is suitable for applying of basic hospital, particularly under-developed area.
The specific embodiment
For fully understanding the present invention's purpose, feature and effect, by following concrete embodiment, the present invention is elaborated.
Pharmaceutical composition of the present invention adopts Radix Codonopsis, Rhizoma Atractylodis Macrocephalae (parched), Poria, Radix Glycyrrhizae Preparata, Cortex Magnoliae Officinalis(processed with ginger), the Radix Aucklandiae, Fructus Amomi, stir-baked RHIZOMA CORYDALIS with vinegar and Rhizoma Pinelliae Preparatum to make, and is obtaining unexpected therapeutic effect aspect the functional dyspepsia of syndrome of spleen-deficiency and QI-stagnation.
The invention provides a kind of pharmaceutical composition for the treatment of functional dyspepsia, calculate by weight, contain Radix Codonopsis 5-30, Rhizoma Atractylodis Macrocephalae (parched) 5-20, Poria 5-20, Radix Glycyrrhizae Preparata 2-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Radix Aucklandiae 5-20, Fructus Amomi 1-10, stir-baked RHIZOMA CORYDALIS with vinegar 5-30 and Rhizoma Pinelliae Preparatum 3-10.
Preferably, the pharmaceutical composition for the treatment of functional dyspepsia of the present invention calculates by weight, contains Radix Codonopsis 15, Rhizoma Atractylodis Macrocephalae (parched) 10, Poria 10, Radix Glycyrrhizae Preparata 5, Cortex Magnoliae Officinalis(processed with ginger) 10, the Radix Aucklandiae 10, Fructus Amomi 6, stir-baked RHIZOMA CORYDALIS with vinegar 15 and Rhizoma Pinelliae Preparatum 10.
The used Radix Codonopsis of the present invention (Radix Codonopsis Pilosulae) is the root of campanulaceae (Campanulaceae) Codonopsis (Codonopsis) plant Radix Codonopsis, element flower Radix Codonopsis, radix codonpsis tangshen, pipe flower Radix Codonopsis, C. subglobosa, C. canescens.Radix Codonopsis has the effect of invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.
The used Rhizoma Atractylodis Macrocephalae (parched) of the present invention is to be that Rhizoma Atractylodis Macrocephalae sheet is extremely light yellow with parched with bran.The Rhizoma Atractylodis Macrocephalae (Rhizoma Atractylodis Macrocephalae) is the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae (Atractylodes macrocephala Koidz.).The Rhizoma Atractylodis Macrocephalae has the effect of invigorating the spleen and benefiting QI, dampness diuretic.
The used Poria of the present invention (Wolfiporia cocos (Schw.) Ryv.﹠amp; Gibn) belong to Polyporaceae (Polyporaceae), Poria belongs to (Wolfiporia).Poria has the effect of spleen invigorating.
The used Radix Glycyrrhizae Preparata of the present invention (Radix Glycyrrhizae Preparata) is that the honey of glycyrrhizic legume is smoked processed goods.Radix Glycyrrhizae Preparata has the effect of spleen reinforcing stomach function regulating, Yiqi and vein recovery.
The used Cortex Magnoliae Officinalis(processed with ginger) of the present invention is bark or the root bark of Magnoliacea plant Cortex Magnoliae Officinalis (Magnoliaof-ficinalisRehd.etWils) or magnolia officinalis rehd.et wils.var.biloba rehd.et wils. (M.biloba (Rehd.et.wils.) Cheng).Cortex Magnoliae Officinalis(processed with ginger) has that alleviating distention in middle-JIAO is regulated the flow of vital energy, the effect of removing dampness dissipating depression of QI.
The used Radix Aucklandiae of the present invention (Radix Aucklandiae) belongs to feverfew.The Radix Aucklandiae has the effect of intestinal stasis relieving in promoting the circulation of QI to relieve pain, the accent.
The dry mature fruit of the used Fructus Amomi of the present invention (Fructus Amomi) zingiberaceous plant Fructus Amomi, green shell sand or SEMEN AMOMI LONGILIGULA.Fructus Amomi has removing dampness appetizing, warming spleen and stopping diarrha effect.
The used stir-baked RHIZOMA CORYDALIS with vinegar of the present invention is got by Rhizoma Corydalis vinegar system, is generally with vinegar Rhizoma Corydalis is mixed thoroughly, infiltrates, and to the vinegar exhaustion, then puts in the pot and fries to little dried with slow fire, takes out, and cools, and every Rhizoma Corydalis 100Kg uses vinegar 20Kg.Rhizoma Corydalis is the tuber of Papaveraceae (Papaveraceae) plant Rhizoma Corydalis and tooth lobe Rhizoma Corydalis.Rhizoma Corydalis have invigorate blood circulation, the effect of promoting the circulation of QI, pain relieving, diuresis.
The used Rhizoma Pinelliae Preparatum of the present invention (Rhizoma Pinelliae Preparatum) is made by the tuber of the aroid Rhizoma Pinelliae (Pinellia ternata (Thunb) Breit.), it is the Preparation process product that drying forms after adopting Rhizoma Pinelliae to soak with the Radix Glycyrrhizae lime liquor, every 100kg Rhizoma Pinelliae is with Radix Glycyrrhizae 15kg, quicklime 10kg.Rhizoma Pinelliae Preparatum has the effect of drying dampness to eliminate phlegm.
The used Chinese medicinal material of the present invention the is all those skilled in the art conventional Chinese medicinal material that uses when treating gastroenteropathy, concocting method of the present invention is all the conventional preparation method of Chinese medicinal material of the art, and those skilled in the art determine and obtain the Chinese herb of the present invention's use easily.That is to say that each Chinese medicinal material that this paper is mentioned so long as can be used in field those medical materials commonly used for the treatment of gastroenteropathy, all can be used in the pharmaceutical composition of the present invention, can make corresponding drug form.
Functional dyspepsia is clinical common a kind of functional gastrointestinal disease, thinks at present that its pathogenesis increases with gastrointestinal motility obstacle, visceral sensitivity, the factors such as the change of helicobacter pylori infections, gut hormone, socio-psychological factors are relevant more.Because pathogenetic complexity has brought certain difficulty for the treatment of functional dyspepsia, the symptomatic treatment of western medical treatment take experience as the basis there is no the special treatment medicine as main at present.Primary disease belongs to the sick category of the traditional Chinese medical science " stomach painful abdominal mass ", makes a general survey of the process of this disease morbidity, often is that eating and drinking without temperance, work and rest are improper, all heresies of diseases caused by exogenous pathogenic factor, the multifactor combined effect of internal damage by the excessive seven emotions, causes weakness of the spleen and stomach, stomach-QI being unable to descend normally, taste abnormal ascending-descending of QI.Pathogenesis is deficiency in origin and excess in superficiality, simulataneous insufficiency and excessive.
The traditional Chinese medical science thinks that feelings will is smooth, excessive thinking, eating accumulation, Exogenous and internal injuries, damp-heat blocking in the body and innate deficiency etc. cause middle burnt mechanism of qi retardance, taste lifting imbalance, gastrointestinal motility dysfunction.Though the sick position of functional dyspepsia is at stomach, dirty in close relations with liver spleen two, clinical manifestation is empty or real, or simulataneous insufficiency and excessive, or coldheat complex.It is cold, hot, empty, real that the present invention has formulated is guiding principle, and syndrome of deficient cold of spleen and stomach, syndrome of spleen-deficiency and QI-stagnation, syndrome of dampness-heat of spleen and stomach, simultaneous occurrence of cold and heat syndromes are purpose clinical diagnosis and treatment scheme.
Syndrome of spleen-deficiency and QI-stagnation is one of common pattern of syndrome of functional dyspepsia.Functional dyspepsia based on syndrome of spleen-deficiency and QI-stagnation has following symptom.Primary symptom: 1. fullness and oppression in the stomach or distending pain; 2. lack of appetite is indigestion and loss of appetite.Inferior disease: 1. whenever freely do not show effect or increase the weight of because of feelings will; 2. belch; 3. singultus; 4. fatigue and weak; 5. light red tongue, white and thin fur; 6. stringy and thready pulse.All possess primary symptom and add time 2 of diseases and can be diagnosed as syndrome of spleen-deficiency and QI-stagnation.
According to the syndrome of spleen-deficiency and QI-stagnation etiology and pathogenesis, use invigorating the spleen and regulating the stomach, the relieving distension of regulating the flow of vital energy is that main method is executed and controlled, the present composition forms for the square foundation addition or subtraction of changes with decoction of four noble drugs (decoction of four noble drugs comes from " formulary of peaceful benevolent dispensary ", is the agent of wanting of invigorating the spleen and regulating the stomach).Radix Codonopsis, Radix Glycyrrhizae Preparata invigorating the spleen and replenishing QI in the present composition, the Poria invigorating the spleen for eliminating dampness, the Rhizoma Atractylodis Macrocephalae (parched) strengthening the spleen to promote digestion adds the merit of strengthening regulating QI to expel dampness, relieving distension pain relieving with the Radix Aucklandiae, Fructus Amomi, Cortex Magnoliae Officinalis, stir-baked RHIZOMA CORYDALIS with vinegar, Rhizoma Pinelliae Preparatum etc.All medicines share, and have both mended the wherein deficiency in origin of burnt taste, and the relieving distension of regulating the flow of vital energy again is except the mark reality of its stagnation of QI, allly demonstrate,prove to such an extent that remove.
The smooth and eating accumulation of feelings will is present in the whole process that functional dyspepsia is fallen ill, the insufficiency of the spleen stagnation of QI is the center pathology link of functional dyspepsia, on the basis of comprehensive integration, for the functional dyspepsia based on syndrome of spleen-deficiency and QI-stagnation, adopt above-mentioned pharmaceutical composition, the symptoms such as fullness and oppression in the stomach, epigastric distending pain, lack of appetite be indigestion and loss of appetite can be obviously improved, and gastric motility can be improved.
Pharmaceutical composition of the present invention can add the regular dosage form that conventional adjuvant is made oral administration according to conventional formulation technique, comprises decoction, granule, tablet, capsule, oral liquid, pill, powder.The conventional formulation technique that the present invention is alleged and adjuvant etc. refer on textbook, national standard, provincial standard disclosed method, technology and adjuvant.
The preparation method of above-mentioned decoction is: calculate by weight, with Radix Codonopsis 5-30, Rhizoma Atractylodis Macrocephalae (parched) 5-20, Poria 5-20, Radix Glycyrrhizae Preparata 2-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Radix Aucklandiae 5-20, Fructus Amomi 1-10, stir-baked RHIZOMA CORYDALIS with vinegar 5-30 and Rhizoma Pinelliae Preparatum 3-10 mix, this medicinal mixture is soaked, institute's water consumption is for surpassing the medicinal mixture powder more than 1/3, soak time is 20-30 minute, boil with big fire after soaking, then slow fire decocts, according to the every 36g-170g meter of each medical material gross weight, decocting to remaining medicinal liquid is 150-300ml, preferred 200ml, repeat above-mentioned decoction process secondary, the gained medicine juice is mixed, then press 150-300ml, preferred 200ml divides out for subsequent use.The preparation method of above-mentioned decoction is this area conventional formulation method.
The preparation method of granule is: calculate by weight, prepare medicinal granule according to Radix Codonopsis 5-30, Rhizoma Atractylodis Macrocephalae (parched) 5-20, Poria 5-20, Radix Glycyrrhizae Preparata 2-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Radix Aucklandiae 5-20, Fructus Amomi 1-10, stir-baked RHIZOMA CORYDALIS with vinegar 5-30 and Rhizoma Pinelliae Preparatum 3-10, with above-mentioned nine kinds of medicine granule for treating mixings, according to the every 36g-170g meter of each medical material gross weight, use the 300ml dissolved in boiled water, divide right and left for subsequent use according to every part of 150ml medicine juice.The granular preparation of above-mentioned nine kinds of medicines can adopt commercially available drug particles.
When adopting pharmaceutical composition of the present invention to be used for the treatment of functional dyspepsia, dosage regimen is as follows: the decoction dosage regimen: the medicinal liquid that each medical material gross weight 36g-170g and water are fried into as stated above, each oral taking medicine once of morning and evening, each 150-300ml, preferred 200ml, take before the meal, 28 days or 30 days is a course for the treatment of.The granule dosage regimen: with the medicinal liquid that each granule medical material gross weight 36g-170g makes with the 300ml water dissolution, each oral taking medicine once of morning and evening, each 150ml takes before the meal, and 28 days or 30 days is a course for the treatment of.
Embodiment
Below, enumerate embodiment the present invention is further described, but the present invention is not limited to following embodiment.
The medicine Preparation Example:
Embodiment 1:
Take by weighing each medicine material (tomorrow, people's Pharmaceutical did not provide said medicine by) according to Radix Codonopsis 15g, Rhizoma Atractylodis Macrocephalae (parched) 10g, Poria 10g, Radix Glycyrrhizae Preparata 5g, Cortex Magnoliae Officinalis(processed with ginger) 10g, Radix Aucklandiae 10g, Fructus Amomi 6g, stir-baked RHIZOMA CORYDALIS with vinegar 15g and Rhizoma Pinelliae Preparatum 10g, with above-mentioned each medicament mixed that takes by weighing, add water to and flood and exceed the medicine powder more than 1/3, soaked 25 minutes, then boil with big fire, then the slow fire decoction is 200ml to remaining medicinal liquid, repeat above-mentioned decoction process secondary, to be divided into two parts after the mixing of gained medicine juice, about every part of 200ml.
Embodiment 2:
Take by weighing each medicine material (tomorrow, people's Pharmaceutical did not provide said medicine by) according to Radix Codonopsis 5g, Rhizoma Atractylodis Macrocephalae (parched) 5g, Poria 5g, Radix Glycyrrhizae Preparata 2g, Cortex Magnoliae Officinalis(processed with ginger) 5g, Radix Aucklandiae 5g, Fructus Amomi 1g, stir-baked RHIZOMA CORYDALIS with vinegar 5g and Rhizoma Pinelliae Preparatum 3g, with above-mentioned each medicament mixed that takes by weighing, add water to and flood and exceed the medicine powder more than 1/3, soaked 20 minutes, then boil with big fire, then the slow fire decoction is 200ml to remaining medicinal liquid, repeat above-mentioned decoction process secondary, to be divided into two parts after the mixing of gained medicine juice, about every part of 200ml.
Embodiment 3:
Take by weighing each medicine material (tomorrow, people's Pharmaceutical did not provide said medicine by) according to Radix Codonopsis 30g, Rhizoma Atractylodis Macrocephalae (parched) 20g, Poria 20g, Radix Glycyrrhizae Preparata 10g, Cortex Magnoliae Officinalis(processed with ginger) 20g, Radix Aucklandiae 20g, Fructus Amomi 10g, stir-baked RHIZOMA CORYDALIS with vinegar 30g and Rhizoma Pinelliae Preparatum 10g, with above-mentioned each medicament mixed that takes by weighing, add water to and flood and exceed the medicine powder more than 1/3, soaked 30 minutes, then boil with big fire, then the slow fire decoction is 200ml to remaining medicinal liquid, repeat above-mentioned decoction process secondary, to be divided into two parts after the mixing of gained medicine juice, about every part of 200ml.
Embodiment 4:
According to Radix Codonopsis 15g, Rhizoma Atractylodis Macrocephalae (parched) 10g, Poria 10g, Radix Glycyrrhizae Preparata 5g, Cortex Magnoliae Officinalis(processed with ginger) 10g, Radix Aucklandiae 10g, Fructus Amomi 6g, stir-baked RHIZOMA CORYDALIS with vinegar 15g and Rhizoma Pinelliae Preparatum 10g, the granule of the said medicine that people's Pharmaceutical provides will mix with tomorrow not, then said mixture is dissolved in the 300ml boiled water, gained solution is divided into two parts, about every part of 150ml.
Embodiment 5:
According to Radix Codonopsis 5g, Rhizoma Atractylodis Macrocephalae (parched) 5g, Poria 5g, Radix Glycyrrhizae Preparata 2g, Cortex Magnoliae Officinalis(processed with ginger) 5g, Radix Aucklandiae 5g, Fructus Amomi 1g, stir-baked RHIZOMA CORYDALIS with vinegar 5g and Rhizoma Pinelliae Preparatum 3g, the granule of the said medicine that people's Pharmaceutical provides will mix with tomorrow not, then said mixture is dissolved in the 300ml boiled water, gained solution is divided into two parts, about every part of 150ml.
Embodiment 6:
According to Radix Codonopsis 30g, Rhizoma Atractylodis Macrocephalae (parched) 20g, Poria 20g, Radix Glycyrrhizae Preparata 10g, Cortex Magnoliae Officinalis(processed with ginger) 20g, Radix Aucklandiae 20g, Fructus Amomi 10g, stir-baked RHIZOMA CORYDALIS with vinegar 30g and Rhizoma Pinelliae Preparatum 10g, the granule of the said medicine that people's Pharmaceutical provides will mix with tomorrow not, then said mixture is dissolved in the 300ml boiled water, gained solution is divided into two parts, about every part of 150ml.
The pharmaceutical properties evaluation test
Below, to the pharmaceutical composition of above-described embodiment preparation, carry out the evaluation experimental of functional dyspepsia curative effect of disease.
The evaluation test of this pharmaceutical properties adopt multicenter, at random, double blinding, placebo-controlled study.Above-mentioned multicenter refers to that Beijing Chinese Medical Hospital, attached to Capital Medical Univ. is the carrier, and Nanjing University of Traditional Chinese Medicine Affiliated Hospital, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine (Liaoning Province institute of traditional Chinese medicine), No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ (Guangdong Provincial TCM Hospital), Xuanwu District, Beijing institute of traditional Chinese medicine are cooperation unit.
1, sufferer group
According to following standard, choose matched group 54 examples, test group 106 examples comprise expulsion rate design 15%.
(1) meets functional dyspepsia doctor trained in Western medicine Rome III diagnostic criteria;
(2) meet syndrome of spleen-deficiency and QI-stagnation, namely meet primary symptom: 1. fullness and oppression in the stomach or distending pain; 2. lack of appetite is indigestion and loss of appetite; Meet as in the next disease more than two, 1. whenever freely do not show effect or increase the weight of because of feelings will; 2. belch; 3. singultus; 4. fatigue and weak; 5. light red tongue, white and thin fur; 6. stringy and thready pulse.
(3) age between 18～65 years old, male or female.
The sufferer of more than selecting is got rid of and is suffered from other gastroenteropathy, the incretion metabolism disease persons such as connective tissue disease, diabetes, climacteric syndrome person; Have the serious constitutional heart, liver, lung, kidney, blood or affect the serious disease person of its existence; The disease that the experiment of the routine clinical such as trimester of pregnancy, women breast-feeding their children is got rid of.
2, used medicine and medication:
Test group: with the preparation of embodiment 4 preparations, according to potion every day, each oral taking medicine is once taken before the meal sooner or later, and each 150ml is a course for the treatment of all around, and first month was followed up a case by regular visits to after treatment finished.
Matched group: placebo according to potion administration every day, is dissolved in placebo in the 300ml boiled water, is divided into two equal portions, each oral taking medicine is once taken before the meal sooner or later, is a course for the treatment of all around, and first month was followed up a case by regular visits to after treatment finished.Placebo is the granule that tomorrow, people's Pharmaceutical did not provide, the composition of granule is respectively that Radix Codonopsis 0.5g adds starch to 15g, Rhizoma Atractylodis Macrocephalae (parched) 0.33g adds starch to 10g, Poria 0.33g adds starch to 10g, Radix Glycyrrhizae Preparata 0.17g adds starch to 5g, Cortex Magnoliae Officinalis(processed with ginger) 0.33 and adds starch to 10g, the Radix Aucklandiae 0.33 adds starch to 10g, and Fructus Amomi 0.2g adds starch and adds starch to 6g, stir-baked RHIZOMA CORYDALIS with vinegar 0.5g and add starch to 10g to 15g and Rhizoma Pinelliae Preparatum 0.33g.
Except the test medication; viewing duration bans use of other treatment Chinese medicine of functional dyspepsia and Western medicine and the other treatment relevant with the primary disease treatment, as using but sour medicine, antacid, digestant, gastrointestinal mucosa are protected medicine, digestive tract power reinforcing medicine, anticholinergic agent, antipsychotic drug, narcotic analgesic medicine, Bendectin, somatostatin class medicine, on (one-tenth) medicine, NSAID (non-steroidal anti-inflammatory drug), amcinonide in the influential effect of gastrointestinal tract, may affect other measures of gastrointestinal function.
Embodiment 1: the TCM Syndrome Theories index
The symptom overall evaluation
1. employing method
Before drug treatment, behind the drug treatment, treatment finish after first month follow up a case by regular visits to, according to table 1, to each test group and matched group patient's gastral cavilty or distension and fullness in the abdomen, gastralgia, diet minimizing, belch singultus, bitter taste xerostomia, fatigue and weak, nausea and vomiting, epigastric upset, uncomfortable in chest, heavy sensation of the body is sleepy, loose stool, oliguria with yellow urine is scored respectively, is symptom integral with each symptom score sum of every patient.
Tcm symptom quantizes grade scale: formulate with reference to " guideline of clinical investigations of new Chinese medicine treatment feeling of fullness " in May, 2002 version " new Chinese medicine guideline of clinical investigations ".
Table 1
2. evaluation methodology
2.1 adopt international SPSS statistical analysis software, after, the treatment front to treating and tcm syndrome total mark, the curative effect grade evaluation of following up a case by regular visits to carry out statistical analysis and calculate.Two-sided test is all adopted in the check of the significance,statistical of this experimental study, and as judging that difference has the standard of statistical significance, P＜0.01 is as the standard of the statistical significance of judging that there was a significant difference with P≤0.05.
2.2 adopt the nimodipine method to calculate, judge test group and each patient's of matched group treatment situation, and with test group and matched group patient respectively according to following criteria classification.Integration * 100% before therapeutic index=(integration after integration before the treatment-treatment)/treatment).
(1) clinic control: therapeutic index 〉=95%.
(2) produce effects: 70%≤therapeutic index＜95%.
(3) effective: 30%≤therapeutic index＜70%.
(4) invalid: therapeutic index＜30%.
3. efficacy result
3.1 tcm syndrome integral estimation
Table 2: two groups of tcm syndrome integral contrasts that treatment is front, treatment is rear and follow up a case by regular visits to
According to table 2, two groups of test group and matched groups are compared P before the treatment＞0.05, difference not statistically significant; Treatment is rear and follow up a case by regular visits to equal P＜0.01, and difference has the significance statistical significance.As can be seen from the above table, in the test group, be far smaller than the front tcm syndrome integral mean value for the treatment of with the tcm syndrome integral mean value of following up a case by regular visits to after the treatment, and be reduced to respectively 3 and 4.5 with the tcm syndrome integration median of following up a case by regular visits to by 22 before treating after the treatment, that is to say the treatment through medicine of the present invention, tcm syndrome has obtained obvious improvement.
3.2 tcm syndrome curative effect grade evaluation
Table 3: tcm syndrome curative effect grade relatively after two groups of treatments
As can be seen from the above table, after the treatment, test group total effective rate 88.7%, matched group total effective rate 59.3%, wherein effective percentage=(clinic control+produce effects+effective)/sufferer number, and two groups of curative effect grades compares P＜0.01, and difference has remarkable statistical significance.
The individual event symptom is estimated
1. the method that adopts
Before drug treatment, behind the drug treatment, treatment finish after first month follow up a case by regular visits to, each indigestion symptom to each test group and matched group patient is estimated respectively from the order of severity, frequency and three aspects of influence degree, the mark addition of three aspects namely obtains the evaluation mark of single symptom, and the higher explanation symptom of mark is heavier.
Functional dyspepsia symptom rating scale
2. evaluation methodology
Adopt international SPSS (9.10) statistical analysis software, after, the treatment front to treating and the individual event symptom score of following up a case by regular visits to carry out statistical analysis and calculate.Two-sided test is all adopted in the check of the significance,statistical of this experimental study, and as judging that difference has the standard of statistical significance, P＜0.01 is as the standard of the statistical significance of judging that there was a significant difference with P≤0.05.
3. efficacy result
Table 4: two groups of tcm syndrome individual event symptom score that treatment is front, treatment is rear and follow up a case by regular visits to relatively
(**P＜0.01，*P＜0.05)
As can be seen from the above table, two groups of test group and matched groups are compared, after the treatment and when following up a case by regular visits to, gastral cavilty or distension and fullness in the abdomen, gastralgia, diet minimizing, belch singultus, dry mouth with bitter taste, fatigue and weak, seven symptom P＜0.01 uncomfortable in chest, difference has the significance statistical significance.In addition, in the test group, be far smaller than the front individual event syndrome integral mean value for the treatment of with the individual event syndrome integral mean value of following up a case by regular visits to after the treatment, that is to say the treatment through medicine of the present invention, every syndrome has all obtained obvious improvement.
Embodiment 2: doctor trained in Western medicine syndrome manifestations index
The symptom overall evaluation
1. the method that adopts
Before drug treatment, behind the drug treatment, treatment finish after first month follow up a case by regular visits to, to each test group and matched group patient's upper abdominal pain, upper abdomen burn feeling, after the meal glutted discomfort, early full sense, feel sick, vomiting, belch, other the order of severity of indigestion symptom mark according to the nothing of table 5, slight, moderate and severe, be symptom integral with each symptom sum of every patient, scoring process is by doctor and patient complete independently respectively.The highest symptom, symptom that the patient pays close attention to the most of giving a mark is patient's cardinal symptom.
Table 5 indigestion symptom score basis
| Mark | Classification | Explanation |
| 0 minute | Asymptomatic | / |
| 1 minute | Slightly | Symptom is slight, only has when concern just can feel, can not affect daily life, working and learning |
| 2 minutes | Moderate | Symptom still can be stood, some effects daily life, working and learning |
| 3 minutes | Severe | Symptom is obvious, and endurable has obviously affected daily life, working and learning |
2. evaluation methodology
2.1 adopt international SPSS (9.10) statistical analysis software, after, the treatment front to treating and the overall symptom integral of doctor trained in Western medicine of following up a case by regular visits to, overall symptom integral curative effect carry out statistical analysis and calculate.Two-sided test is all adopted in the check of the significance,statistical of this experimental study, and as judging that difference has the standard of statistical significance, P＜0.01 is as the standard of the statistical significance of judging that there was a significant difference with P≤0.05.
2.2 by improving the percentage rate=front total mark of (total mark after total mark before the treatment-treatment)/treatment * 100%, calculate the doing well,improving percentage rate, judge test group and each patient's of matched group treatment situation according to following standard, and with test group and matched group patient respectively according to following criteria classification.
(1) doing well,improving percentage rate 〉=75% is evident in efficacy.
(2) 51%≤doing well,improving percentage rate＜75% is that curative effect is better.
(3) 25%≤doing well,improving percentage rate＜50% is that curative effect is general.
(4) doing well,improving percentage rate＜25% is invalid, is deterioration during doing well,improving percentage rate negative value.
3. efficacy result
3.1 overall symptom integral evaluation
Table 6: two groups treatment is front, treatment is rear and the overall symptom integral of doctor trained in Western medicine that follow up a case by regular visits to compares
As can be seen from the above table, two groups of test group and matched groups are compared P before the treatment＞0.05, difference not statistically significant; Treatment is rear and follow up a case by regular visits to equal P＜0.01, and difference has the significance statistical significance.In addition, in the test group, be improved as 2 with the doctor trained in Western medicine syndrome integration median of following up a case by regular visits to by 7 before treating after the treatment, that is to say the treatment through medicine of the present invention, the doctor trained in Western medicine syndrome has obtained obvious improvement.
3.2 overall symptom integral curative effect grade evaluation
Table 7: two groups of overall symptom integral curative effects of doctor trained in Western medicine relatively
As can be seen from the above table, test group total effective rate 69.8% after the treatment, matched group total effective rate 44.4%, wherein effective percentage=(evident in efficacy+curative effect is better)/sufferer number, and two groups of curative effect grades compares P＜0.01, and difference has remarkable statistical significance.
The individual event symptom is estimated
1. the method that adopts
Before drug treatment, behind the drug treatment, treatment finish after first month follow up a case by regular visits to, each indigestion symptom to each test group and matched group patient is estimated respectively from the order of severity, frequency and three aspects of influence degree, the mark addition of three aspects namely obtains the evaluation mark of single symptom, and the higher explanation symptom of mark is heavier.
Functional dyspepsia symptom rating scale
2. evaluation methodology
Adopt international SPSS (9.10) statistical analysis software, after, the treatment front to treating and the individual event symptom score of following up a case by regular visits to carry out statistical analysis and calculate.Two-sided test is all adopted in the check of the significance,statistical of this experimental study, and as judging that difference has the standard of statistical significance, P＜0.01 is as the standard of the statistical significance of judging that there was a significant difference with P≤0.05.
3. efficacy result
3.1 the individual event symptom integral is estimated
Table 8: before the treatment, after the treatment and the individual event symptom score of following up a case by regular visits to relatively
**P＜0.01，*P＜0.05.
As can be seen from the above table, two groups of test group and matched groups are compared, after the meal glutted discomfort, two symptom P＜0.01 of full sense early after the treatment, difference has the significance statistical significance; Upper abdomen burn feeling P＜0.05, difference has statistical significance.Upper abdominal pain when following up a case by regular visits to, after the meal glutted discomfort, early full sense P＜0.01, two group difference has the significance statistical significance.In addition, in the test group, after the treatment and the individual event syndrome integral mean value of following up a case by regular visits to be far smaller than individual event syndrome integral mean value before the treatment, that is to say the treatment through medicine of the present invention, upper abdominal pain, upper abdomen burn feeling, after the meal glutted discomfort, early four syndromes of full sense have all obtained obvious improvement.
Embodiment 3 stomach and intestine dynamics indexs
1. the method that adopts
Test group and matched group check respectively 1 time before treatment, obtain unusual case 32 examples of test group, unusual case 10 examples of matched group.Above unusual case is finished check in 3 days in treatment.
Preparation before examination: the standard test-meal is a, comprises Chef Kang's board Lentinus Edodes Carnis Gallus domesticus instant noodles 97 grams, the two board ham sausage that converge of 45g, boiled water 400ml; Show 1 bottle (including length 10mm, little 20 in the barium sulfate of diameter 1mm) of son, take down with breakfast.About 490 kilocalories of above-mentioned food total amount of heat.
Inspection method: check advanced dinner → morning 6:00 eat the breakfast → advanced in the 5-10 minute breakfast → after this prohibit diet and medicine of 18:00 in the afternoon day before yesterday, rear 5 hours (about 11:00AM) rested → had meal to bed to the clinical research hospital radiological department → foaming agent 3g swallows, health overturn for two weeks, take 1 of clinostatism abdomen plain film, calculate gastric residue barium bar number.
Points for attention: reliable and stable for guaranteeing experimental result, check the inactive medicine that affects gastrointestinal function the last week, this inspection X sheet is responsible for shooting by the special messenger.
2. evaluation methodology
Adopt international SPSS (9.10) statistical analysis software, carry out statistical analysis calculating to discharging barium bar difference (discharging the barium number before discharging barium number-treatment after treating) before and after the treatment.Two-sided test is all adopted in the check of the significance,statistical of this experimental study, and as judging that difference has the standard of statistical significance, P＜0.01 is as the standard of the statistical significance of judging that there was a significant difference with P≤0.05.
3. efficacy result
Discharge barium bar difference relatively before and after the table 9 liang group treatment
As can be seen from the above table, compare after the test group treatment with before the treatment, the average of discharging the difference of barium bar has reached 5.16 ± 7.53, that is to say adopt Drug therapy of the present invention after, discharge barium number showed increased, the Stomach in Patients intestinal motive force obviously improves.Discharge barium bar difference P＜0.05 after the treatment, difference has statistical significance.
Embodiment 4 Evaluation on quality of life indexs
1. the method that adopts
The Chinesizing version SF-36 health survey scale (healthy universality scale SF-36) that adopts professor Li Lu of Zhejiang University to provide is estimated physiological function (PF), physiological function (RP), body pain (BP), general health (GH), vigor (VT), social function (SF), emotion function (RE), 8 dimensions of Mental Health (MH).The Li Ke summation is used in scoring of each dimension, presses last topic value calculating raw score, uses normalized form " whole score=(actual just score-minimum possibility score)/(the highest possibility score-minimum possibility score) * 100 " to calculate transmuted score again.Last each dimension must be divided into 0 minute (the poorest)-100 minutes (best).Above-mentioned 8 subscales are further returned into two classes: PF, RP, BP, GH are healthy general comment (the physical component Summary of body, PCS), VT, SF, RE, MH are Mental Health general comment (mental component Summary, MCS).1st month (Z) carried out record to test group and matched group after (Y) and treatment finished after (X), treatment finished before treatment respectively.Adopt international SPSS (9.10) statistical analysis software, after, the treatment front to treating, treatment finish after first month Evaluation on quality of life scale score value carry out statistical analysis and calculate.Two-sided test is all adopted in the check of the significance,statistical of this experimental study, and as judging that difference has the standard of statistical significance, P＜0.01 is as the standard of the statistical significance of judging that there was a significant difference with P≤0.05.
2. efficacy result
Table 10 liang group treatment is front, treatment is rear, treatment finishes rear first month quality of life scale integral contrast
**P＜0.01，*P＜0.05.
As can be seen from the above table, two groups of test group and matched groups are compared, the treatment back body is healthy, Mental Health P＜0.05, two group difference has statistical significance; First month body health, Mental Health P＜0.01, two group difference had the significance statistical significance after treatment finished.In addition, in the test group, obviously greater than the healthy average of the body before the treatment, Mental Health average, that is to say the treatment through medicine of the present invention with the body health average of following up a case by regular visits to, Mental Health average after the treatment, patients ' life quality has arrived obvious improvement.
The drug safety evaluation experimental
Adverse events may be: new disease; The deterioration of therapeutic state Sx, or the deterioration of accompanying diseases; The effect of control drug etc.
1. adverse events and medicine cause effect relation determination methods
According to the standard (referring to " new Chinese medicine guideline of clinical investigations (trying) ") that work out at Ministry of Public Health adverse drug reaction supervision center, by " certainly, probably, possible, suspicious, impossible " five-category method assessment is made in the association that may exist between adverse events and the test medication.
2. evaluation criterion
(1) 1 grade: safety, without any untoward reaction.
(2) 2 grades: safer, if any untoward reaction, need not do any processing and can continue administration, on experimenter's rehabilitation without impact.
(3) 3 grades: safety issue is arranged, moderate untoward reaction is arranged, experimenter's endurable needs withdrawal to end to test or do special handling and can continue administration, and experimenter's rehabilitation is had a direct impact.
(4) 4 grades: end test because of untoward reaction, jeopardize experimenter's life, cause death or disable, need immediately withdrawal or do emergent management.
3. evaluation conclusion
The every safety indexes of all patients does not occur unusually after the treatment, treats and follow up a case by regular visits to not occur adverse events in the process, and safety is good.
Claims (3)
1. a pharmaceutical composition for the treatment of functional dyspepsia is characterized in that, calculates by weight, and said composition is comprised of Radix Codonopsis 15, Rhizoma Atractylodis Macrocephalae (parched) 10, Poria 10, Radix Glycyrrhizae Preparata 5, Cortex Magnoliae Officinalis(processed with ginger) 10, the Radix Aucklandiae 10, Fructus Amomi 6, stir-baked RHIZOMA CORYDALIS with vinegar 15 and Rhizoma Pinelliae Preparatum 10.
2. a preparation of being made by the pharmaceutical composition for the treatment of functional dyspepsia claimed in claim 1 is characterized in that, the dosage form of said preparation is: decoction or granule.
3. method for preparing decoction, calculate by weight, Radix Codonopsis 15, Rhizoma Atractylodis Macrocephalae (parched) 10, Poria 10, Radix Glycyrrhizae Preparata 5, Cortex Magnoliae Officinalis(processed with ginger) 10, the Radix Aucklandiae 10, Fructus Amomi 6, stir-baked RHIZOMA CORYDALIS with vinegar 15 and Rhizoma Pinelliae Preparatum 10 are mixed, medicinal mixture is soaked, institute's water consumption is for surpassing the medicinal mixture powder more than 1/3, soak time is 20-30 minute, boil with big fire after soaking, then slow fire decocts, according to the every 36g-170g meter of each medical material gross weight, decocting to remaining medicinal liquid is 150-300ml, repeats above-mentioned decoction process secondary, and the gained medicine juice is mixed.
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| CN102935194B (en) * | 2012-12-06 | 2014-12-10 | 中国科学院昆明植物研究所 | Traditional Chinese medicine or food for promoting digestion function and detoxifying and beautifying as well as preparation method and applications thereof |
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| CN104013895A (en) * | 2014-05-20 | 2014-09-03 | 柳晖 | Traditional Chinese medicine composition for treating epigastric pain caused by duodenal ulcer |
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| CN104958636A (en) * | 2015-07-29 | 2015-10-07 | 青岛蓝盛洋医药生物科技有限责任公司 | Medicinal composition for treating functional dyspepsia and preparation method of medicinal composition |
| CN106334109A (en) * | 2016-08-31 | 2017-01-18 | 安徽省润生医药股份有限公司 | Medicinal composition for treating dyspepsia, preparation method thereof and preparation |
| CN110090283A (en) * | 2019-05-27 | 2019-08-06 | 广东省中医院（广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院） | A kind of Chinese medicine composition that treating spleen-deficiency qi-stagnation type functional dyspepsia FD, preparation method and water decoction |
| CN112089809A (en) * | 2020-10-29 | 2020-12-18 | 杨玉良 | Traditional Chinese medicine composition with spleen invigorating and qi benefiting functions, traditional Chinese medicine plaster and preparation method thereof |
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