CN102302758A - 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 PDF

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CN102302758A
CN102302758A CN201110260384A CN201110260384A CN102302758A CN 102302758 A CN102302758 A CN 102302758A CN 201110260384 A CN201110260384 A CN 201110260384A CN 201110260384 A CN201110260384 A CN 201110260384A CN 102302758 A CN102302758 A CN 102302758A
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rhizoma
radix
pharmaceutical composition
processed
calcined
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CN102302758B (en
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张声生
汪红兵
吴兵
赵鲁卿
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Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital University of Medicine Sciences
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Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital University of Medicine Sciences
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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

The pharmaceutical composition and the method for making of treatment simultaneous occurrence of cold and heat syndromes functional dyspepsia
Technical field
The present invention relates to a kind of pharmaceutical composition of treating functional dyspepsia, particularly relate to a kind of treatment based on pharmaceutical composition of the functional dyspepsia of simultaneous occurrence of cold and heat syndromes and its production and application.
Background technology
Functional dyspepsia (functional dyspepsia; FD) be one group of, abdominal part flatulence glutted with persistence or repeatability outbreak epigastrium pain, food back, belch, early full, anorexia, 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 indigestion symptom prescription on individual diagnosis person between 20~49%, the functional dyspepsia sickness rate is further ascendant trend in China, is the sick hot research fields of digestion always.
For functional dyspepsia; The predicament that western medicine faces is: 1. pathogenesis is not illustrated as yet fully: possibly relate to the multiple factors such as sensitivity, inflammation, HP infection of dyskinesis, internal organs, so think that functional dyspepsia is that multiple physiology and the social factor gastrointestinal motility disorder of participating in is diseases related.2. lack specific treatment, the state of an illness easily repeatedly, the labor medical resource.Western medicine mainly is short digestive tract power, protection gastric mucosa medicine and the utilization that presses down sour medicine 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 to 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 property and pathogenesis is indeterminate and the defective of symptomatic treatment only; Provide a kind of and adopt Chinese medicine, through 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 process pharmaceutical composition; Through 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 scheme that the present invention adopts is, a kind of pharmaceutical composition of treating 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 of treating 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 processed by the pharmaceutical composition of above-mentioned treatment functional dyspepsia, and 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; Soaking the back boils with big fire; The slow fire decoction is 150-300ml to remaining medicinal liquid then; 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, open subsequent use according to every part of 150ml branch then.
Wherein, the Chinese medicine medical 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 market.
Aforesaid method for preparing 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 the treatment functional dyspepsia, especially based on the functional dyspepsia of simultaneous occurrence of cold and heat syndromes.
Pharmaceutical composition of the present invention; With pungent drugs can disperse and bitter drugs can descend is that the method for letting out falls in activating YANG with pungent and warm drugs and bitter cold; Hot Wen Yisheng scatters strongly fragrant; Bitter cold is with the turbid descending that purges heat; To functional dyspepsia based on simultaneous occurrence of cold and heat syndromes; Can obviously improve symptoms such as gastral cavilty feeling of fullness, gastralgia, noisy pantothenic acid, solve the Western medicine cause of disease and pathogenesis is indeterminate, the defective of symptomatic treatment only.
In addition, pharmaceutical composition of the present invention is with low cost, and institute's medicament all is a 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, characteristic and effect,, the present invention is elaborated by following concrete embodiment.
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 process, and aspect the functional dyspepsia of simultaneous occurrence of cold and heat syndromes, is obtaining unexpected therapeutic effect.
The present invention provides a kind of pharmaceutical composition of treating 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 of treatment 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 processed 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 the interior no dried heart; Mouth is tasted little numb feeling in the tongue that has; Take out, clean, cut sheet; Drying promptly 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 heat clearing and damp drying, antiabortive, the antidotal effect of removing heat from blood.
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, plain flower Radix Codonopsis, radix codonpsis tangshen, pipe flower Radix Codonopsis, globe daisy Radix Codonopsis, gray wool Radix Codonopsis.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 the 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 method for preparing 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 method for preparing of conventional Massa Medicata Fermentata is: with bright Herba Artemisiae Annuae, bright Herba Xanthii, each 12Kg of bright Herba polygoni hydropiperis, and chopping respectively; 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, flour 60Kg, it is an amount of to add water then; Piece kneads; Flatten the back and cover, make it fermentation, when appearance grows yellow mycelia, take out with Caulis et Folium Oryzae or gunnysack; Be cut into the fritter of about 3 centimeter square, dry.
The used Concha Arcae (calcined) of the present invention is processed 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 medicine medical material of the present invention is all those skilled in the art's conventional Chinese medicine medical material that uses when treating gastroenteropathy; Concocting method according to the invention is all the conventional Chinese crude drug concocting method in present technique field, and those skilled in the art confirm and obtain the Chinese medicine raw material of the present invention's use easily.That is to say that each Chinese medicine medical material that this paper is mentioned so long as can be used in field those medical materials commonly used of treatment gastroenteropathy, all can be used in the pharmaceutical composition of the present invention, can process 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, factors such as the change of helicobacter pylori infections, gut hormone, socio-psychological factors are relevant more.Because pathogenetic complexity has brought certain degree of difficulty for the treatment of functional dyspepsia, western medical treatment is that the symptomatic treatment on basis is main with the experience at present, does not still have the special treatment medicine.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 a 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, diseases caused by exogenous pathogenic factor internal injury, damp-heat blocking in the body and innate deficiency etc. cause in burnt mechanism of qi retardance, the taste imbalance of going up and down, 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 uses pungent drugs can disperse and bitter drugs can descend, mildly regulating cold and heat to execute for main method and controls according to the simultaneous occurrence of cold and heat syndromes etiology and pathogenesis.The present invention simplifies for basis side adds to cut out with banxia xiexin decoction (coming from treatise on Febrile Diseases, is the agent of wanting of mildly regulating cold and heat) and forms.Rhizoma Pinelliae, the hot temperature of Rhizoma Zingiberis are removed and are trembled 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 that full, the merit of relieving gastric hyperacidity to alleviate stomachache, strengthening the spleen to promote digestion.All medicines are shared, remove its cold and heat, and multiple its up-down 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.
Feelings will is smooth to be present in the whole process that functional dyspepsia is fallen ill with eating accumulation; The present invention adopts above-mentioned pharmaceutical composition; With pungent drugs can disperse and bitter drugs can descend is that the method for letting out falls in activating YANG with pungent and warm drugs and bitter cold; Hot Wen Yisheng scatters strongly fragrant; Bitter cold is with the turbid descending that purges heat; To functional dyspepsia, can obviously improve symptoms such as gastral cavilty feeling of fullness, gastralgia, noisy pantothenic acid based on simultaneous occurrence of cold and heat syndromes.
Pharmaceutical composition of the present invention can add the regular dosage form that conventional adjuvant is processed oral administration according to conventional formulation technology, comprises decoction, granule, tablet, capsule, oral liquid, pill, powder.Conventional formulation technology that the present invention is alleged and adjuvant etc. are meant on textbook, national standard, provincial standard disclosed method, technology and adjuvant.
The method for preparing 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; Soaking the back boils with big fire; Slow fire decocts then; 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, press 150-300ml then, preferred 200ml branch is opened subsequent use.The method for preparing of above-mentioned decoction is this area conventional formulation method.
The method for preparing 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, open subsequent use according to every part of 150ml branch then.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 to treat functional dyspepsia; Dosage regimen is following: the decoction dosage regimen: with the fried as stated above medicinal liquid that becomes of each medical material gross weight 43g-210g and water; 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 of treatment.The granule dosage regimen: with the medicinal liquid that each granule medical material gross weight 43g-210g processes 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 of treatment.
Embodiment
Below, enumerate embodiment the present invention is further described, but the present invention is not limited to following embodiment.
Medication preparation embodiment:
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; Boil with big fire then; 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; Boil with big fire then; 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; Boil with big fire then; 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; Said mixture is dissolved in the 300ml boiled water then; 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; Said mixture is dissolved in the 300ml boiled water then; 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; Said mixture is dissolved in the 300ml boiled water then; Gained solution is divided into two parts, about every part of 150ml.
The pharmaceutical properties evaluation test
Below, to the pharmaceutical composition of the foregoing description preparation, carry out the evaluation experimental of functional dyspepsia curative effect of disease.
The evaluation test of this pharmaceutical properties adopt multicenter (how tame hospital participates in), at random, double blinding, placebo-controlled study.Above-mentioned multicenter is meant 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, promptly meet primary symptom: 1. gastral cavilty feeling of fullness or pain; 2. noisy pantothenic acid; Meet as in the next disease more than two, it is heavy 1. to meet cold rnning; 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 for use is got rid of and is suffered from other gastroenteropathy, incretion metabolism disease persons such as connective tissue disease, diabetes, climacteric syndrome person; Have the serious constitutional heart, liver, lung, kidney, blood or influence the serious disease person of its existence; The disease that the experiment of routine clinical such as trimester of pregnancy, women breast-feeding their children is got rid of.
2, institute's medicament and medication:
Test group: with the preparation of embodiment 4 preparations, according to potion every day, each oral taking medicine once of morning and evening is taken before the meal, and each 150ml is a course of treatment all around, and treatment finishes first moon of back and follows up a case by regular visits to.
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 of treatment all around, and treatment finishes first moon of back and follows up a case by regular visits to.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 that the test medication; Viewing duration ban use of other treatment functional dyspepsia Chinese medicine and Western medicine and with the relevant other treatment of primary disease treatment, like use 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, to (one-tenth) medicine, NSAID (non-steroidal anti-inflammatory drug), amcinonide in the influential effect of gastrointestinal tract, possibly influence other measures of gastrointestinal function.
Embodiment 1: tcm syndrome is learned index
1. employing method
Before drug treatment, behind the drug treatment, treatment finishes back first month and follows 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 " the clinical research guideline of new Chinese medicine treatment feeling of fullness " in May, 2002 version " new Chinese medicine clinical research guideline ".
Table 1
2. evaluation methodology
2.1 adopt international SPSS (9.10) statistical analysis software,, treatment back preceding 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 test group and matched group patient are classified according to standards respectively.Integration * 100% before therapeutic index=(integration before the treatment-treatment back integration)/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: before two groups of treatments, treatment back and the tcm syndrome integration of following up a case by regular visits to relatively
According to table 2, test group and matched group are compared P before the treatment>0.05, difference not statistically significant for two groups; Treat the back and follow up a case by regular visits to equal P<0.01, difference has the significance statistical significance.Can find out that from last table in the test group, the treatment back is far smaller than the preceding tcm syndrome integral mean value of treatment with the tcm syndrome integral mean value of following up a case by regular visits to, and that is to say the treatment through medicine of the present invention, tcm syndrome has obtained tangible improvement.
3.2 tcm syndrome curative effect grade evaluation
Table 3: two groups of treatment back tcm syndrome curative effect grades relatively
Figure BDA0000088966210000111
Can find out from last 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 index
The symptom overall evaluation
1. the method for Cai Yonging
Before drug treatment, behind the drug treatment, treatment finishes back first month and follows up a case by regular visits to; To each test group and matched group patient's upper abdominal pain, upper abdomen burn feeling, glutted discomfort, full sense early after the meal, feel sick, vomiting, belch, other the order of severity of indigestion symptom mark according to the nothing of table 4, slight, moderate and severe; With each symptom sum of every patient is symptom integral, and scoring process is by doctor and the independent respectively completion of patient.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, has only when concern just can feel, can not influence 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, is difficult to stand, and has obviously influenced daily life, working and learning
2. evaluation methodology
2.1 adopt international SPSS (9.10) statistical analysis software,, treatment back preceding 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 are carried out statistical analysis and are calculated.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 percentage rate=(total mark before the treatment-treatment back the total mark)/preceding total mark of treatment * 100%; Calculate the doing well,improving percentage rate; Judge test group and each patient's of matched group treatment situation according to standards, and test group and matched group patient are classified according to standards respectively.
(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: before the treatment, treatment back and the overall symptom integral of doctor trained in Western medicine of following up a case by regular visits to relatively
Figure BDA0000088966210000131
Can find out from last table, test group and matched group are compared for two groups, P before the treatment>0.05, difference not statistically significant; Treat the back and follow up a case by regular visits to equal P<0.01, difference has the significance statistical significance.In addition, in the test group, the treatment back is far smaller than the preceding doctor trained in Western medicine syndrome integral mean value of treatment with the doctor trained in Western medicine syndrome integral mean value of following up a case by regular visits to, and that is to say the treatment through medicine of the present invention, and the doctor trained in Western medicine syndrome has obtained tangible 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
Figure BDA0000088966210000132
Can find out from last table, treatment back test group total effective rate 76.1%, 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 for Cai Yonging
Before drug treatment, behind the drug treatment, treatment finishes back first month and follows 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 promptly obtains the evaluation mark of single symptom, and the high more explanation symptom of mark is heavy more.
Functional dyspepsia symptom rating scale
Figure BDA0000088966210000141
2. evaluation methodology
Adopt international SPSS (9.10) statistical analysis software,, treatment back preceding to treating and the individual event symptom score of following up a case by regular visits to are carried out statistical analysis and are calculated.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
Figure BDA0000088966210000151
**P<0.01, *P<0.05.
Can find out from last table, test group and matched group are compared for two groups, treatment back upper abdominal pain, upper abdomen burn feeling, glutted discomfort, four the equal P of symptom<0.01 of full sense early after the meal, 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; Treatment back and the individual event syndrome integral mean value of following up a case by regular visits to are far smaller than the 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 tangible improvement.
Embodiment 3 quality of life evaluation index
1. the method for Cai Yonging
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), physiology 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 keeping the score of each dimension, presses last topic value calculating raw score, and reuse normalized form " whole score=(actual score just-minimum possibility score)/(the highest possibility score-minimum possibility score) * 100 " calculates transmuted score.Last each dimension must be divided into 0 minute (the poorest)-100 minutes (best).Above-mentioned 8 subscales are further returned into two types: PF, RP, BP, GH be the healthy general comment of body (physical component Summary, PCS), VT, SF, RE, MH be the Mental Health general comment (mental component Summary, MCS).(X), treatment finish back (Y) and treat end back 1st month (Z) test group and matched group are carried out record before treatment respectively.Adopt international SPSS (9.10) statistical analysis software,, treatment back preceding to treating, treatment finish back quality of life first month and estimate the scale score value and 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: before two groups of treatments, treatment back, treatment finish back quality of life first month scale integration relatively
Figure BDA0000088966210000171
**P<0.01, *P<0.05.
Can find out from last table, test group and matched group are compared for two groups that the healthy P of treatment back body<0.05, two group of difference has statistical significance; Treatment finishes the healthy P of back first month body<0.01, two group of difference has the significance statistical significance, and Mental Health P<0.05, two group difference has statistical significance.In addition, in the test group, the treatment back 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, and patients ' life quality has arrived tangible improvement.
The drug safety evaluation experimental
Adverse events possibly 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 clinical research guideline (trying) ") that work out at Ministry of Public Health adverse drug reaction supervision center, assessment is made in the association that possibly exist between adverse events and the test medication by " certainly, probably, possible, suspicious, impossible " Pyatyi classification method.
2. evaluation criterion
(1) 1 grade: safety, there is not any untoward reaction.
(2) 2 grades: compare safety,, need not do any processing and can continue administration, experimenter's rehabilitation is not had influence if any untoward reaction.
(3) 3 grades: safety issue is arranged, moderate untoward reaction is arranged, the experimenter is difficult to stand, and needs withdrawal to end to test or do special handling and can continue administration, and experimenter's rehabilitation is had direct influence.
(4) 4 grades: end test because of untoward reaction, jeopardize experimenter's life, cause death or disable, need withdrawal immediately or do emergent management.
3. evaluation conclusion
All patient's each item safety indexes of treatment back do not occur unusually, treat and follow up a case by regular visits to occur 1 routine adverse events in the process, and are irrelevant through analyzing with clinical trial.

Claims (8)

1. a pharmaceutical composition of treating functional dyspepsia is characterized in that, 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).
2. a pharmaceutical composition of treating the simultaneous occurrence of cold and heat syndromes functional dyspepsia is characterized in that, 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).
3. the pharmaceutical composition of treatment functional dyspepsia according to claim 1 and 2; 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 of treatment 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 processed 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; Soaking the back boils with big fire; Slow fire decocts then; 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, open subsequent use according to every part of 150ml branch then.
8. according to each described method for preparing of claim 6-7, it is characterized in that, calculate by weight, use 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
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
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
CN116763880A (en) * 2023-07-31 2023-09-19 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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CN1296837A (en) * 1999-04-05 2001-05-30 阚士宇 Chinese patent medicine for treating peptide ulcer
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CN1296837A (en) * 1999-04-05 2001-05-30 阚士宇 Chinese patent medicine for treating peptide ulcer
CN101279003A (en) * 2008-04-21 2008-10-08 济南康众医药科技开发有限公司 Enema medicament for promoting anal exsufflation and preparation

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Publication number Priority date Publication date Assignee Title
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
CN116763880A (en) * 2023-07-31 2023-09-19 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
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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