CN102302758B - Pharmaceutical composition for treating functional dyspepsia (FD) based on intermingled cold and heat symptom and preparation method thereof - Google Patents
Pharmaceutical composition for treating functional dyspepsia (FD) based on intermingled cold and heat symptom and preparation method thereof Download PDFInfo
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Abstract
The invention provides a pharmaceutical composition for treating functional dyspepsia (FD) based on an intermingled cold and heat symptom and a preparation method thereof. The pharmaceutical composition comprises the following bulk drugs in parts by weight: 10 parts of rhizoma pinelliae preparata, 10 parts of radix scutellariae, 5 parts of rhizoma coptidis, 10 parts of dried ginger, 15 parts of pilose asiabell root, 5 parts of fresh liquorice, 10 parts of officinal magnolia bark, 15 parts of stir-fried medicated leaven and 30 parts of calcined ark shell. The pharmaceutical composition overcomes the defects that the existing pharmaceutical preparation for treating FD has undefined indefinite etiology and pathogenesis as well as only symptomatic treatment; and the pharmaceutical composition for treating FD based on the intermingled cold and heat symptom is safe and active, 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 simultaneous occurrence of cold and heat syndromes 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, provide a kind of and adopt Chinese medicine, by pungent drugs can disperse and bitter drugs can descend method treatment based on pharmaceutical composition of the functional dyspepsia of simultaneous occurrence of cold and heat syndromes and preparation method thereof, 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 Rhizoma Pinelliae, Radix Scutellariae, Rhizoma Coptidis, Rhizoma Zingiberis, Radix Codonopsis, Radix Glycyrrhizae, Cortex Magnoliae Officinalis(processed with ginger), Massa Medicata Fermentata preparata and Concha Arcae (calcined) to make pharmaceutical composition, by the pungent drugs can disperse and bitter drugs can descend method, at the treatment functional dyspepsia, especially the functional dyspepsia aspect based on simultaneous occurrence of cold and heat syndromes 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 contains Rhizoma Pinelliae, Radix Scutellariae, Rhizoma Coptidis, Rhizoma Zingiberis, Radix Codonopsis, Radix Glycyrrhizae, Cortex Magnoliae Officinalis(processed with ginger), Massa Medicata Fermentata preparata and Concha Arcae (calcined).
The present invention also provides a kind of pharmaceutical composition for the treatment of the simultaneous occurrence of cold and heat syndromes functional dyspepsia, contains Rhizoma Pinelliae, Radix Scutellariae, Rhizoma Coptidis, Rhizoma Zingiberis, Radix Codonopsis, Radix Glycyrrhizae, Cortex Magnoliae Officinalis(processed with ginger), Massa Medicata Fermentata preparata and Concha Arcae (calcined).
The pharmaceutical composition of aforesaid treatment functional dyspepsia calculates by weight, contains Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60.
The pharmaceutical composition of aforesaid treatment functional dyspepsia calculates by weight, contains Rhizoma Pinelliae 10, Radix Scutellariae 10, Rhizoma Coptidis 5, Rhizoma Zingiberis 10, Radix Codonopsis 15, Radix Glycyrrhizae 5, Cortex Magnoliae Officinalis(processed with ginger) 10, Massa Medicata Fermentata preparata 15 and Concha Arcae (calcined) 30.
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, Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60 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 Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60, 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, the Chinese medicinal material of Rhizoma Pinelliae, Radix Scutellariae, Rhizoma Coptidis, Rhizoma Zingiberis, Radix Codonopsis, Radix Glycyrrhizae, Cortex Magnoliae Officinalis(processed with ginger), Massa Medicata Fermentata preparata and Concha Arcae (calcined) and their granular preparation all can be commercially available from the market.
Aforesaid preparation method is calculated by weight, uses Rhizoma Pinelliae 10, Radix Scutellariae 10, Rhizoma Coptidis 5, Rhizoma Zingiberis 10, Radix Codonopsis 15, Radix Glycyrrhizae 5, Cortex Magnoliae Officinalis(processed with ginger) 10, Massa Medicata Fermentata preparata 15 and Concha Arcae (calcined) 30.
Pharmaceutical composition of the present invention is mainly used in treating functional dyspepsia, especially based on the functional dyspepsia of simultaneous occurrence of cold and heat syndromes.
Pharmaceutical composition of the present invention, be that the method for letting out falls in activating YANG with pungent and warm drugs and bitter cold with pungent drugs can disperse and bitter drugs can descend, hot Wen Yisheng scatters strongly fragrant, bitter cold is with the turbid descending that purges heat, for the functional dyspepsia based on simultaneous occurrence of cold and heat syndromes, can obviously improve the symptoms such as gastral cavilty feeling of fullness, gastralgia, noisy pantothenic acid, solve 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 Rhizoma Pinelliae, Radix Scutellariae, Rhizoma Coptidis, Rhizoma Zingiberis, Radix Codonopsis, Radix Glycyrrhizae, Cortex Magnoliae Officinalis(processed with ginger), Massa Medicata Fermentata preparata and Concha Arcae (calcined) to make, and is obtaining unexpected therapeutic effect aspect the functional dyspepsia of simultaneous occurrence of cold and heat syndromes.
The invention provides a kind of pharmaceutical composition for the treatment of functional dyspepsia, calculate by weight, contain Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60.
Preferably, the pharmaceutical composition for the treatment of functional dyspepsia of the present invention calculates by weight, contains Rhizoma Pinelliae 10, Radix Scutellariae 10, Rhizoma Coptidis 5, Rhizoma Zingiberis 10, Radix Codonopsis 15, Radix Glycyrrhizae 5, Cortex Magnoliae Officinalis(processed with ginger) 10, Massa Medicata Fermentata preparata 15 and Concha Arcae (calcined) 30.
The used Rhizoma Pinelliae of the present invention (Rhizoma Pinelliae Preparata) is made by the tuber of the Rhizoma Arisaematis section plant Rhizoma Pinelliae (Pinellia ternata (Thunb.) Breit.), get the Rhizoma Pinelliae that cleans up, size is separated, and the alum solution with 8% soaks, to interior without the dried heart, mouth is tasted little numb feeling in the tongue that has, take out, clean, cut sheet, drying namely gets Rhizoma Pinelliae.Every 100kg Rhizoma Pinelliae is used the 20kg Alumen.Rhizoma Pinelliae has the effect of drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.
The used Radix Scutellariae of the present invention (Radix Scutellariae) is the root of labiate Radix Scutellariae (Scutellaria baicalensis Georgi).Radix Scutellariae has that heat clearing and damp drying, removing heat from blood are antiabortive, the effect of detoxifcation.
The used Rhizoma Coptidis of the present invention (Coptis chinensis Franch) is the dry rhizome of ranunculaceae plant Rhizoma Coptidis (Coptis chinensis Franch.), Coptis deltoidea C.Y.Cheng et Hsiao (Coptis deltoidea C.Y.Chenget Hsiao) or Coptis Teeta Wall (Coptis teeta Wall.).Rhizoma Coptidis has the effect of heat clearing and damp drying, eliminating fire and detoxication.
The used Rhizoma Zingiberis of the present invention is the dry rhizome of zingiber (Zingiber officinale Rosc.).Rhizoma Zingiberis has that warming spleen and stomach for dispelling cold, recuperating depleted YANG are promoted blood circulation, the effect of dampness expectorant, warming the lung to resolve fluid-retention.
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 Radix Glycyrrhizae of the present invention (Radix Glycyrrhizae) is the dry root and rhizome of glycyrrhizic legume (Glycyrrhiza uralensis Fisch.), Glycyrrhiza inflata Bat. (Glycyrrhiza Inflata Bat.) or Glycyrrhiza glabra L. (Glycyrrhiza Glabra L.).Radix Glycyrrhizae has the effect of invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
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 preparation method of the used Massa Medicata Fermentata preparata of the present invention (Massa Medicata Fermentata) is: Massa Medicata Fermentata parched with bran to yellow is used as medicine.Massa Medicata Fermentata preparata has strengthening the spleen to promote digestion, regulating QI to expel dampness, the effect of inducing sweat.Conventional commercially available Massa Medicata Fermentata can both be applied to the present invention, and the preparation method of conventional Massa Medicata Fermentata is: with bright Herba Artemisiae Annuae, bright Herba Xanthii, each 12Kg of bright Herba polygoni hydropiperis, and respectively chopping; 6Kg Semen Phaseoli stone roller end, the peeling of 6Kg Semen Armeniacae Amarum are ground, the said medicine mixing is mixed thoroughly, add Testa Tritici 100Kg, then flour 60Kg adds water an amount of, be kneaded into agglomerate, cover with Caulis et Folium Oryzae or gunnysack after flattening, make it fermentation, when appearance grows yellow mycelia, take out, be cut into the approximately fritter of 3 centimeter square, dry.
The used Concha Arcae (calcined) of the present invention is made by the shell of Carnis Arca inflata section animal Scapharca broughtonii, Tegillarca granosa or Scapharca subcrenata.Concha Arcae (calcined) has the effect of expectorant blood stasis dispelling, hard masses softening and resolving, relieving gastric hyperacidity to alleviate stomachache.
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 easily determine and obtain the Chinese herb of the present invention's use.That is to say, 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.
Simultaneous occurrence of cold and heat syndromes is one of common pattern of syndrome of primary disease.Functional dyspepsia based on simultaneous occurrence of cold and heat syndromes has following symptom.Primary symptom: 1. gastral cavilty feeling of fullness or pain; 2. noisy pantothenic acid.Inferior disease: 1. meet cold rnning and weigh; 2. dry mouth with bitter taste; 3. cold extremities loose stool; 4. belch; 5. indigestion and loss of appetite; 6. pale tongue with white fur; 7. wiry and frequent pulse.All possess primary symptom and add time 2 of diseases and can be diagnosed as simultaneous occurrence of cold and heat syndromes.
The present invention is according to the simultaneous occurrence of cold and heat syndromes etiology and pathogenesis, is that main method is executed and controlled with pungent drugs can disperse and bitter drugs can descend, mildly regulating cold and heat.The present invention forms for the square foundation addition or subtraction of changes with banxia xiexin decoction (coming from treatise on Febrile Diseases, is the agent of wanting of mildly regulating cold and heat).Rhizoma Pinelliae, the hot temperature of Rhizoma Zingiberis are except trembling with fear the normalizing the stomach by guiding QI downward preventing or arresting vomiting in the present composition; Rhizoma Coptidis, Radix Scutellariae purging with bitter and cold drugs heat extraction; Radix Codonopsis, Radix Glycyrrhizae invigorating the spleen and replenishing QI, nourishing the stomach; Add with Cortex Magnoliae Officinalis(processed with ginger), Concha Arcae (calcined), Massa Medicata Fermentata preparata etc. and strengthen circulation of qi promoting except full, the merit of relieving gastric hyperacidity to alleviate stomachache, strengthening the spleen to promote digestion.All medicines share, and except its cold and heat, multiple its lifting is mended wherein burntly, and cold and heat must be transferred, and temper must rise, and gastric qi must be fallen, and 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 present invention adopts above-mentioned pharmaceutical composition, be that the method for letting out falls in activating YANG with pungent and warm drugs and bitter cold with pungent drugs can disperse and bitter drugs can descend, hot Wen Yisheng scatters strongly fragrant, bitter cold is with the turbid descending that purges heat, for the functional dyspepsia based on simultaneous occurrence of cold and heat syndromes, can obviously improve the symptoms such as gastral cavilty feeling of fullness, gastralgia, noisy pantothenic acid.
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 Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60 mixes, 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 43g-210g 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 above-mentioned granule is: calculate by weight, prepare medicinal granule according to Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60, with above-mentioned nine kinds of medicine granule for treating mixings, according to the every 43g-210g meter of each medical material gross weight, use the 300ml dissolved in boiled water, then separately for subsequent use according to every part of 150ml.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 43g-210g 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 43g-210g 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 Rhizoma Pinelliae 10g, Radix Scutellariae 10g, Rhizoma Coptidis 5g, Rhizoma Zingiberis 10g, Radix Codonopsis 15g, Radix Glycyrrhizae 5g, Cortex Magnoliae Officinalis(processed with ginger) 10g, Massa Medicata Fermentata preparata 15g and Concha Arcae (calcined) 30g, 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 Rhizoma Pinelliae 3g, Radix Scutellariae 5g, Rhizoma Coptidis 2g, Rhizoma Zingiberis 5g, Radix Codonopsis 5g, Radix Glycyrrhizae 3g, Cortex Magnoliae Officinalis(processed with ginger) 5g, Massa Medicata Fermentata preparata 5g and Concha Arcae (calcined) 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 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 Rhizoma Pinelliae 10g, Radix Scutellariae 20g, Rhizoma Coptidis 10g, Rhizoma Zingiberis 20g, Radix Codonopsis 30g, Radix Glycyrrhizae 10g, Cortex Magnoliae Officinalis(processed with ginger) 20g, Massa Medicata Fermentata preparata 30g and Concha Arcae (calcined) 60g, 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 Rhizoma Pinelliae 10g, Radix Scutellariae 10g, Rhizoma Coptidis 5g, Rhizoma Zingiberis 10g, Radix Codonopsis 15g, Radix Glycyrrhizae 5g, Cortex Magnoliae Officinalis(processed with ginger) 10g, Massa Medicata Fermentata preparata 15g and Concha Arcae (calcined) 30g, 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 Rhizoma Pinelliae 3g, Radix Scutellariae 5g, Rhizoma Coptidis 2g, Rhizoma Zingiberis 5g, Radix Codonopsis 5g, Radix Glycyrrhizae 3g, Cortex Magnoliae Officinalis(processed with ginger) 5g, Massa Medicata Fermentata preparata 5g and Concha Arcae (calcined) 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 6:
According to Rhizoma Pinelliae 10g, Radix Scutellariae 20g, Rhizoma Coptidis 10g, Rhizoma Zingiberis 20g, Radix Codonopsis 30g, Radix Glycyrrhizae 10g, Cortex Magnoliae Officinalis(processed with ginger) 20g, Massa Medicata Fermentata preparata 30g and Concha Arcae (calcined) 60g, 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.
Multicenter (many hospitals participate in), random, double blinding, placebo-controlled study are adopted in the evaluation test of this pharmaceutical properties.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 35 examples, test group 70 examples comprise expulsion rate design 15%.
(1) meets functional dyspepsia doctor trained in Western medicine Rome III diagnostic criteria;
(2) meet simultaneous occurrence of cold and heat syndromes, namely meet primary symptom: 1. gastral cavilty feeling of fullness or pain; 2. noisy pantothenic acid; Meet as in the next disease more than two, 1. meet cold rnning heavy; 2. dry mouth with bitter taste; 3. cold extremities loose stool; 4. belch; 5. indigestion and loss of appetite; 6. pale tongue with white fur; 7. wiry and frequent 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 Rhizoma Pinelliae 0.33g adds starch to 10g, Radix Scutellariae 0.33g adds starch to 10g, Rhizoma Coptidis 0.167g adds starch to 5g, Rhizoma Zingiberis 0.33g adds starch and adds starch to 15g to 10g, Radix Codonopsis 0.5g, Radix Glycyrrhizae 0.167g adds starch to 5g, and Cortex Magnoliae Officinalis(processed with ginger) 0.33g adds starch and adds starch to 10g, Massa Medicata Fermentata preparata 0.5g and add starch to 30g to 15g and Concha Arcae (calcined) 1g.
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
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 (9.10) 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, 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 89.6%, matched group total effective rate 47.1%, 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.
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 4, 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 4 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 5: 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 far smaller than the front doctor trained in Western medicine syndrome integral mean value for the treatment of with the doctor trained in Western medicine 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, the doctor trained in Western medicine syndrome has obtained obvious improvement.
3.2 overall symptom integral curative effect grade evaluation
Table 6: 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 76.1% after the treatment, matched group total effective rate 32.4%, 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 7: treatment front and back and the individual event symptom integral of following up a case by regular visits to compare
**P＜0.01，
*P＜0.05.
As can be seen from the above table, two groups of test group and matched groups are compared, upper abdominal pain after the treatment, upper abdomen burn feeling, after the meal glutted discomfort, four the equal P of symptom＜0.01 of full sense early, difference has the significance 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, upper abdomen burn feeling P＜0.05, difference has 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 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.
Table 8: two groups 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 healthy P for the treatment of back body＜0.05, two group of difference has statistical significance; The healthy P of first month body＜0.01, two group of difference had the significance statistical significance after treatment finished, and Mental Health P＜0.05, two group difference has statistical significance.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 occur 1 routine adverse events in the process, and is irrelevant with clinical trial by analysis.
Claims (8)
1. pharmaceutical composition for the treatment of functional dyspepsia, it is characterized in that, calculate by weight, contain Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60.
2. the pharmaceutical composition for the treatment of functional dyspepsia according to claim 1, it is characterized in that, calculate by weight, contain Rhizoma Pinelliae 10, Radix Scutellariae 10, Rhizoma Coptidis 5, Rhizoma Zingiberis 10, Radix Codonopsis 15, Radix Glycyrrhizae 5, Cortex Magnoliae Officinalis(processed with ginger) 10, Massa Medicata Fermentata preparata 15 and Concha Arcae (calcined) 30.
3. pharmaceutical composition for the treatment of the simultaneous occurrence of cold and heat syndromes functional dyspepsia, it is characterized in that, calculate by weight, contain Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60.
4. the pharmaceutical composition for the treatment of functional dyspepsia according to claim 3, it is characterized in that, calculate by weight, contain Rhizoma Pinelliae 10, Radix Scutellariae 10, Rhizoma Coptidis 5, Rhizoma Zingiberis 10, Radix Codonopsis 15, Radix Glycyrrhizae 5, Cortex Magnoliae Officinalis(processed with ginger) 10, Massa Medicata Fermentata preparata 15 and Concha Arcae (calcined) 30.
5. a preparation of being made by the pharmaceutical composition of each described treatment functional dyspepsia among the claim 1-4 is characterized in that, the dosage form of said preparation is: decoction or granule.
6. method for preparing decoction, calculate by weight, with Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60 mixes, 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 43g-210g 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.
7. method for preparing granule, calculate by weight, prepare medicinal granule according to Rhizoma Pinelliae 3-10, Radix Scutellariae 5-20, Rhizoma Coptidis 2-10, Rhizoma Zingiberis 5-20, Radix Codonopsis 5-30, Radix Glycyrrhizae 3-10, Cortex Magnoliae Officinalis(processed with ginger) 5-20, Massa Medicata Fermentata preparata 5-30, Concha Arcae (calcined) 10-60, with above-mentioned nine kinds of medicine granule for treating mixings, according to the every 43g-210g meter of each medical material gross weight, use the 300ml dissolved in boiled water, then separately for subsequent use according to every part of 150ml.
8. each described preparation method is characterized in that according to claim 6-7, calculates by weight, uses Rhizoma Pinelliae 10, Radix Scutellariae 10, Rhizoma Coptidis 5, Rhizoma Zingiberis 10, Radix Codonopsis 15, Radix Glycyrrhizae 5, Cortex Magnoliae Officinalis(processed with ginger) 10, Massa Medicata Fermentata preparata 15 and Concha Arcae (calcined) 30.
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| CN105106807A (en) * | 2015-09-02 | 2015-12-02 | 宗焕波 | Traditional Chinese medicine composition for treating cold and heat intermingling type functional dyspepsia |
| CN110833609A (en) * | 2018-08-16 | 2020-02-25 | 中国中医科学院望京医院 | Traditional Chinese medicine composition for treating dyspepsia |
| CN108785642A (en) * | 2018-08-28 | 2018-11-13 | 楚雄齐苏堂中医门诊部 | A kind of pharmaceutical composition of coordination of cold and heat and the preparation method and application thereof |
| CN116763880B (en) * | 2023-07-31 | 2024-01-30 | 浙江省立同德医院(浙江省精神卫生研究院) | Traditional Chinese medicine composition and preparation for treating functional dyspepsia accompanied with emaciation and application of traditional Chinese medicine composition and preparation |
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| CN1232694A (en) * | 1999-03-09 | 1999-10-27 | 李胤良 | Health beverage capable of clearing six kinds of stagnation syndromes |
| CN1296837A (en) * | 1999-04-05 | 2001-05-30 | 阚士宇 | Chinese patent medicine for treating peptide ulcer |
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| CN1232694A (en) * | 1999-03-09 | 1999-10-27 | 李胤良 | Health beverage capable of clearing six kinds of stagnation syndromes |
| CN1296837A (en) * | 1999-04-05 | 2001-05-30 | 阚士宇 | Chinese patent medicine for treating peptide ulcer |
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