CN104491640A - Pharmaceutical composition for treating functional dyspepsia - Google Patents
Pharmaceutical composition for treating functional dyspepsia Download PDFInfo
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- CN104491640A CN104491640A CN201410822234.4A CN201410822234A CN104491640A CN 104491640 A CN104491640 A CN 104491640A CN 201410822234 A CN201410822234 A CN 201410822234A CN 104491640 A CN104491640 A CN 104491640A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/344—Codonopsis
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/535—Perilla (beefsteak plant)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
- A61K36/725—Ziziphus, e.g. jujube
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition for treating functional dyspepsia. The pharmaceutical composition consists of the following components: codonopsis pilosula, bighead atractylodes rhizome, jujube, perilla stem, medicated leaven, dried orange peel, galangal, cassia twig, clove and radix paeoniae alba. The pharmaceutical composition disclosed by the invention, which is totally prepared from Chinese herbal medicines, has functions of invigorating spleen and replenishing qi, warming stomach and lowering adverse-rising energy; the pharmaceutical composition is concrete in curative effect on the functional dyspepsia and especially on functional dyspepsia caused by deficiency-cold in spleen and stomach, and the pharmaceutical composition is good in market prospect.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of pharmaceutical composition for the treatment of functional dyspepsia.
Background technology
Dyspepsia is that (dyspepsia) refers to that one group shows as epigastrium pain or burn feeling, post-prandial fullness and early full syndrome, can accompany inappetence, belch, n or V.According to the cause of disease of indigestion symptom, dyspepsia is divided into Organic dyspepsia and functional dyspepsia (functional dyspepsia, FD).The name of disease of FD is not had in Chinese medicine.According to the difference of the cause of disease, pathogenesis, pathological changes internal organs and characteristic of disease in one's power, the category such as " gastric abscess ", " feeling of fullness ", " noisy " can be belonged to, be a kind of common functional gastrointestinal disease, there is the symptoms such as Upper abdominal pain or discomfort (comprising Abdeminal pain, early full, nausea and vomiting, burn feeling, belch and inenarrable epigastric discomfort sense).
FD is as one of the commonly encountered diseases of Digestive System Department, and domestic sickness rate about 23%, accounts for 40% of digestive system disease Number of Outpatients.Primary disease and the liver failing to maintain the normal flow of QI, dysfunction of the spleen in transportation, stomach-QI being unable to descend normally is relevant, and by its clinical manifestation, its differentiation of symptoms and signs for classification of syndrome has depression and stagnation of QI type, liver-fire invading the stomach type, stagnation of turbid phlegm in middle-JIAO type, stasis blocking stomach network type, spleen-stomach deficiency-cold, stomach-yin deficiency etc.
Western medicine is by treatment FD such as short digestive tract power, protection gastric mucosa, acid suppression, anti-helicobacter pylori (HP), anxiety and antidepressants; there is certain curative effect; but life-time service side effect is many; Chinese medicine makes some progress the understanding of the etiology and pathogenesis of FD and treatment aspect; curative effect is comparatively reliable; the Western medicine of ratio has the advantages such as more economical, few side effects, relapse rate are low, and the Chinese medicine composition for this reason studying effective treatment functional dyspepsia is very necessary.
Summary of the invention
The invention provides a kind of new pharmaceutical composition for the treatment of functional dyspepsia, this pharmaceutical composition is rapid-action, good effect, toxic and side effects is little, and it is obtained by following raw material: Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Fructus Jujubae, Caulis Perillae, Massa Medicata Fermentata, Pericarpium Citri Reticulatae, Rhizoma Kaempferiae, Ramulus Cinnamomi, Flos Caryophylli, the Radix Paeoniae Alba.
Radix Codonopsis, nature and flavor are sweet, flat, nontoxic.Gui Jing: to start with, meridian of Foot-TAI YIN edema caused by disorder of QI.Cure mainly invigorating middle warmer, QI invigorating, promote the production of body fluid.Control weakness of the spleen and stomach, deficiency of both QI and blood, fatigue and lack of strength, lack of appetite, thirsty, chronic diarrhea, proctoptosis.
The Rhizoma Atractylodis Macrocephalae, bitter, sweet, temperature.Return spleen, stomach warp.Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.
Fructus Jujubae, nature and flavor are sweet, temperature.Return spleen, stomach warp.Cure mainly spleen reinforcing stomach function regulating, supplementing QI for promoting the production of body fluid, adjust battalion to defend, separate poison of drug.Control insufficiency of stomach lack of appetite, the weak loose stool of spleen, qi-blood-body fluid is not enough, disharmony of nutrient QI with defensive QI, severe palpitation.Married woman's stolen goods are hot-tempered.
Caulis Perillae, pungent, temperature.Return lung, spleen channel.Regulating the flow of QI to ease the stomach, pain relieving, antiabortive.Vexed for chest and diaphragm painful abdominal mass, gastralgia, belch is vomitted, frequent fetal movement.
Massa Medicata Fermentata, sweet; Pungent; Temperature; Nontoxic.Spleen; Stomach warp.Invigorating the spleen and regulating the stomach; Promoting digestion and removing stagnation.Main retention of food and drink; Dyspepsia; Distension and fullness in the abdomen; Inappetence; Vomiting dysentery.
Pericarpium Citri Reticulatae, bitter, pungent, temperature.Return lung, spleen channel.Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.
Rhizoma Kaempferiae, temperature; Pungent; Return stomach warp.Circulation of qi promoting warming middle-JIAO, helps digestion, pain relieving.For chest and diaphragm distension, coldness and pain in the epigastrium, diet does not disappear.
Ramulus Cinnamomi, acrid, sweet, warm.GUIXIN, lung, urinary bladder channel.Diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.For anemofrigid cold, coldness and pain in the epigastrium, cold in blood amenorrhea, arthralgia, phlegm retention, edema, cardiopalmus, renal mass.
Flos Caryophylli, temperature; Pungent; Return spleen, stomach, lung, kidney channel.Warming middle-JIAO to send down the adverse QI, reinforcing the kidney and supporting YANG.For Deficiency and coldness of spleen and stomach, singultus is vomitted, lack of appetite and vomiting, trusted subordinate's cold type of pain, impotence due to deficiency of the kidney.
The Radix Paeoniae Alba, bitter, sour, be slightly cold.Return liver, spleen channel.Suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.Dizzy for having a headache, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.
In pharmaceutical composition of the present invention, select the sweet temperature of Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, invigorating the spleen and benefiting QI, Fructus Jujubae sweet in the mouth, temperature, spleen reinforcing stomach function regulating, supplementing QI for promoting the production of body fluid; Caulis Perillae acrid in the mouth, warm in nature, there is regulating the flow of QI to ease the stomach, Massa Medicata Fermentata, bitter in the mouth, warm in nature, there is strengthening the spleen to promote digestion, regulating QI to expel dampness effect, the pungent perfume (or spice) of Pericarpium Citri Reticulatae and going, kind regulating functional activities of vital QI, adjust smooth in burnt and make it lifting in order; Rhizoma Kaempferiae, Ramulus Cinnamomi regulating QI to relieve pain, diaphoresis tonify deficiency; Flos Caryophylli warming middle-JIAO to send down the adverse QI, reinforcing the kidney and supporting YANG, the acid of the Radix Paeoniae Alba, relieving spasm to stop pain.All medicines share, can spleen invigorating stomach warming again can regulating functional activities of qi, play the merit of invigorating the spleen and benefiting QI, stomach warming sending down the abnormal ascending QI altogether.
The technical scheme adopted for solving its technical problem is the pharmaceutical composition of described treatment functional dyspepsia, be made up of the medicine material of following weight: Radix Codonopsis 9-15 part, Rhizoma Atractylodis Macrocephalae 5-15 part, Fructus Jujubae 10-20 part, Caulis Perillae 5-12 part, Massa Medicata Fermentata 5-11 part, Pericarpium Citri Reticulatae 4-8 part, Rhizoma Kaempferiae 2-6 part, Ramulus Cinnamomi 2-6 part, Flos Caryophylli 1-5 part, Radix Paeoniae Alba 1-5 part.
The preferred technical solution of the present invention is, described pharmaceutical composition of the present invention is obtained by the raw material of following weight portion: Radix Codonopsis 12 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, 15 parts, Fructus Jujubae, Caulis Perillae 9 parts, Massa Medicata Fermentata 8 parts, Pericarpium Citri Reticulatae 6 parts, Rhizoma Kaempferiae 4 parts, Ramulus Cinnamomi 4 parts, Flos Caryophylli 3 parts, the Radix Paeoniae Alba 3 parts.
Present invention also offers the preparation method of described pharmaceutical composition, after specifically comprising the steps: that the raw material Radix Codonopsis of above-mentioned weight portion, Caulis Perillae, Massa Medicata Fermentata, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Rhizoma Kaempferiae, the Radix Paeoniae Alba, Ramulus Cinnamomi, Flos Caryophylli, Fructrs Jujubae Powder are broken into coarse powder, add the water of 5 times amount of coarse powder gross weight, decoct three times, each is 1.5h, filters, when the filtrate after merging is concentrated into 75 DEG C, its relative density is the thick paste of 1.30-1.34.
Those skilled in the art directly can be used as medicine on obtained active constituents of medicine basis of the present invention to use or add on pharmaceutics acceptable adjuvant routinely technique be prepared into required preparation.As the oral drugs of the solid dosage form such as conventional tablet (dispersible tablet, effervescent tablet, oral cavity disintegration tablet, buccal tablet, chewable tablet, effervescent tablet), capsule (hard capsule, soft capsule), granule, pill (drop pill), powder can be made, the oral drugs of the liquid forms such as syrup, oral liquid, water preparation, mixture, decoction also can be made.Preferably, pharmaceutical composition of the present invention conveniently preparation technology be prepared into oral liquid, granule, electuary or powder.
The present invention also asks to protect aforementioned pharmaceutical compositions in the purposes of preparation treatment functional dyspepsia particularly in preparation treatment spleen-stomach deficiency-cold dyspepsia medicine.Known by clinical trial, after two groups of patient treatment 1 courses for the treatment of, total effects compares, and treatment group cure rate is 32.6%, and matched group is 14.3%, and cure rate compares, and the equal < 0.05 of P value, has significant difference; Total effective rate treatment group is 93.0%, and matched group is 71.4%, and total effective rate compares, and the equal < 0.05 of P value, has significant difference.
Routine blood test, hepatic and renal function, electrocardiogram change without exception before and after treatment group patient treatment, in therapeutic process, vital sign is steadily and without the untoward reaction such as nausea and vomiting, allergy.
Pharmaceutical composition of the present invention is natural pure Chinese medicinal preparation, and raw material is easy to get, with low cost, follows the prescriptions principle prescription of the traditional Chinese medical science.Verify through clinical practice, use medicine composite for curing dyspepsia of the present invention particularly to treat and belong to spleen-stomach deficiency-cold dyspepsia determined curative effect, mild in medicine property and, there is not toxic and side effects and serious adverse reaction, clinical observation total effective rate reaches more than 90%, serve the remarkable result for the treatment of both the principal and secondary aspects of a disease, can be used as the dyspeptic active drug for the treatment of spleen-stomach deficiency-cold, be worth of widely use in clinical.Medicine medication prepared by the present invention is simultaneously convenient, improves the compliance of dyspepsia patient.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, but the present invention is not limited only to following specific embodiment.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
embodiment 1
The each raw material of the present invention is taken: Radix Codonopsis 12 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, 15 parts, Fructus Jujubae, Caulis Perillae 9 parts, Massa Medicata Fermentata 8 parts, Pericarpium Citri Reticulatae 6 parts, Rhizoma Kaempferiae 4 parts, Ramulus Cinnamomi 4 parts, Flos Caryophylli 3 parts, the Radix Paeoniae Alba 3 parts by following weight portion.
Preparation technology is as follows: after the raw material Radix Codonopsis of above-mentioned weight portion, the Rhizoma Atractylodis Macrocephalae, Fructus Jujubae, Caulis Perillae, Massa Medicata Fermentata, Pericarpium Citri Reticulatae, Rhizoma Kaempferiae, Ramulus Cinnamomi, Flos Caryophylli, the Radix Paeoniae Alba are ground into coarse powder, add the water of 5 times amount of coarse powder gross weight, decoct three times, each is 1.5h, filter, when filtrate after merging is concentrated into 75 DEG C, its relative density is the thick paste of 1.30-1.34.Those skilled in the art directly can be used as medicine on this basis and be used or add adjuvant conventional formulation technique and obtain the conventional oral formulations such as oral liquid, granule, electuary or powder.
When using medicine composite for curing dyspepsia of the present invention to demonstrate,prove, take prepared oral liquid, every bottle contains crude drug amount 10g, each 1 bottle, 2 times on the one.Take prepared granule, electuary or powder, every bag contains crude drug amount 5g, each 2 bags, 2 times on the one.
embodiment 2
The each raw material of the present invention is taken: Radix Codonopsis 9 parts, the Rhizoma Atractylodis Macrocephalae 5 parts, 10 parts, Fructus Jujubae, Caulis Perillae 5 parts, Massa Medicata Fermentata 5 parts, Pericarpium Citri Reticulatae 4 parts, Rhizoma Kaempferiae 2 parts, Ramulus Cinnamomi 2 parts, Flos Caryophylli 1 part, the Radix Paeoniae Alba 1 part by following weight portion.
Preparation technology is with embodiment 1.
embodiment 3
The each raw material of the present invention is taken: Radix Codonopsis 15 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, 20 parts, Fructus Jujubae, Caulis Perillae 12 parts, Massa Medicata Fermentata 11 parts, Pericarpium Citri Reticulatae 8 parts, Rhizoma Kaempferiae 6 parts, Ramulus Cinnamomi 6 parts, Flos Caryophylli 5 parts, the Radix Paeoniae Alba 5 parts by following weight portion.
Preparation technology is with embodiment 1.
embodiment 4
The each raw material of the present invention is taken: Radix Codonopsis 9 parts, the Rhizoma Atractylodis Macrocephalae 5 parts, 20 parts, Fructus Jujubae, Caulis Perillae 12 parts, Massa Medicata Fermentata 5 parts, Pericarpium Citri Reticulatae 4 parts, Rhizoma Kaempferiae 6 parts, Ramulus Cinnamomi 6 parts, Flos Caryophylli 1 part, the Radix Paeoniae Alba 1 part by following weight portion.
Preparation technology is with embodiment 1.
embodiment 5
The each raw material of the present invention is taken: Radix Codonopsis 15 parts, the Rhizoma Atractylodis Macrocephalae 15 parts, 10 parts, Fructus Jujubae, Caulis Perillae 5 parts, Massa Medicata Fermentata 11 parts, Pericarpium Citri Reticulatae 8 parts, Rhizoma Kaempferiae 2 parts, Ramulus Cinnamomi 2 parts, Flos Caryophylli 5 parts, the Radix Paeoniae Alba 5 parts by following weight portion.
Preparation technology is with embodiment 1.
the clinical observation of embodiment 6 medicine composite for curing functional dyspepsia of the present invention
1, case-data: patient 85 example meeting functional dyspepsia (syndrome of deficient cold of spleen and stomach) diagnostic criteria selecting hospital ward and outpatient clinic.The method of employing random packet, parallel control is studied.
Institute include in the object of observation, treatment group: 43 example, man 20 example, female 23 example, age 18-55 year, 41 years old mean age, slight 14 example, moderate 23 example, severe 6 example.Matched group: 42 example, man 20 example, female 22 example, age 19-56 year, 42 years old mean age, slight 15 example, moderate 22 example, severe 5 example.
Two groups of ages, body weight, course of disease situation compares, equal tool comparability (P > 0.05).
2, diagnosis basis:
1) the tcm diagnosis standard of epigastric fullness
(1) conscious stomach headquarters or seat of leading organs of an institute like the Chinese Academy of Sciences painful abdominal mass plug, distension or distending pain are uncomfortable;
(2) onset is slow, time light time heavy, recurrent exerbation is more than 2 months;
(3) morbidity normal with diet, feelings will, daily life, the cold inducement such as warm be relevant.
All possess above 1,2, with reference to 3 and other symptoms, tongue fur, pulse condition and diagnosable.
2) TCM syndrome diagnostic criteria: syndrome of deficient cold of spleen and stomach
Main symptom: (1) cold syndrome of the stomach dull pain or feeling of fullness, (2) like warm pain relieved by pressing.
Secondary card: (1) general vomiting watery fluid, (2) are indigestion and loss of appetite, and (3) Mental fatigue is indolent and listless, (4) hands and feet being not warm, and (5) stool is warded off thin,
(6) pale tongue with white fur, (7) thready and weak pulse.
Syndrome is determined: all possess main symptom to add time card 2 diagnosable be Deficiency and coldness of spleen and stomach.
3) Western medicine diagnose standard: in U.S.'s disease for digest meeting in May, 2006, propose up-to-date diagnostic criteria, i.e. Rome III standard:
Patient has the symptom occurred for 3 months more than with the next item down or several at least in 6 months in the past: early full sense, post-prandial fullness discomfort, upper abdomen burn feeling, Upper abdominal pain, and does not have organic disease can explain above-mentioned symptom (comprising splanchnoscopy).
3, inclusive criteria:
(1) the tcm diagnosis standard of feeling of fullness and the syndrome diagnostic criterion of Deficiency and coldness of spleen and stomach is met
(2) Western medicine diagnose is met;
(3) age is between 18-60 year;
(4) " Informed Consent Form " person is signed.
4, exclusion standard:
(1) " Informed Consent Form " person is not signed.
(2) gestation, preparation gestation or women breast-feeding their children.
(3) psychotic, or diabetics, or be in severe anxiety depressive state, there is the patient of suicidal tendency.
(4) merging peptic ulcer, erosive gastritis, atrophic gastritis, Previous abdominal surgery, gastric mucosa have severe dysplasia, or pathological diagnosis is suspected to have the person of cancerating.
(5) the serious disease persons such as the heart, brain, liver, kidney and hemopoietic system are merged.
(6) suspect or truly have ethanol, history of substance abuse, or according to the judgement of researcher, having and reduce into group probability or make into other complicated pathological changes of group or situation, as working environment often change, living environment is unstable etc. easily causes situation lost to follow-up.
(7) known maybe may to trial drug and component allergy sufferers thereof.
5, to reject and the standard that comes off:
(1), after case is selected in, find not meet inclusive criteria or meet exclusion standard person;
(2) there is serious adverse events, judge to stop this case clinical trial person according to doctor;
(3) case selected after data not entirely or not by specifying medication person;
(4) in process of the test, experimenter's compliance is poor, and affect the treatment estimator.
6, usage and dosage:
General treatment:
(1) diet cold and cool, pungent, stimulate, rotten, stiff food, delicious food savoury of not taking food, can not satiate, must strict wine for giving off smoking;
(2) harmonizing emotions, keeps good phychology and daily life system rule, does not take food before sleeping;
(3) having regular daily life, avoids aggravating activities and competitive activity.
Treatment group: take Drug therapy of the present invention, granule prepared by Example 1, every bag contains crude drug amount 5g, each 2 bags, 2 times on the one.
Matched group: domperidone tablet (the accurate word H10910003 of traditional Chinese medicines, 10 milligrams), oral, one time 1,3 times on the one, 20 minutes ante cibum took.
Being used in conjunction 2 weeks was 1 course for the treatment of.Recovery from illness case is followed up a case by regular visits to 3 months after terminating the course for the treatment of.
7, efficacy evaluation:
(1) cure: gastric abscess and other transference cure, x-ray canel barium meal contrast examination or gastroscopy normal.
(2) take a turn for the better: stomachache is alleviated, attack times reduces, and other symptoms alleviate, and x-ray canel barium meal contrast examination or gastroscopy take a favorable turn.
(3) do not heal: symptom without improvement, x-ray canel barium meal contrast examination or gastroscopy unchanged.
8, therapeutic effect:
Without rejecting and the case that comes off in therapeutic process, all complete clinical observation.
After two groups of patient treatment 1 courses for the treatment of, total effects compares, and treatment group cure rate is 32.6%, and matched group is 14.3%, and cure rate compares, and the equal < 0.05 of P value, has significant difference; Total effective rate treatment group is 93.0%, and matched group is 71.4%, and total effective rate compares, and the equal < 0.05 of P value, has significant difference.
The comparitive study of table 1. treatment group and matched group
| Group | Cure | Take a turn for the better | Do not heal | Total effective rate |
| Treatment group | 14 | 26 | 3 | 40（93.0%） |
| Matched group | 6 | 24 | 12 | 30（71.4%） |
Routine blood test, hepatic and renal function, electrocardiogram change without exception before and after treatment group patient treatment, in therapeutic process, vital sign is steadily and without the untoward reaction such as dizzy, irritated of feeling sick, therapeutic outcome shows that treatment group cure rate and effective percentage are obviously better than matched group, has significant difference.
Illustrate that using medicine composite for curing functional dyspepsia of the present invention particularly to treat belongs to spleen-stomach deficiency-cold functional dyspepsia thus, have significant curative effect, clinical practice is safe and reliable, is worth research further and promotes.
Claims (8)
1. treat the pharmaceutical composition of functional dyspepsia for one kind, it is characterized in that, it is obtained by the raw material of following weight portion: Radix Codonopsis 9-15 part, Rhizoma Atractylodis Macrocephalae 5-15 part, Fructus Jujubae 10-20 part, Caulis Perillae 5-12 part, Massa Medicata Fermentata 5-11 part, Pericarpium Citri Reticulatae 4-8 part, Rhizoma Kaempferiae 2-6 part, Ramulus Cinnamomi 2-6 part, Flos Caryophylli 1-5 part, Radix Paeoniae Alba 1-5 part.
2. pharmaceutical composition as claimed in claim 1, it is characterized in that, it is obtained by the raw material of following weight portion: Radix Codonopsis 12 parts, the Rhizoma Atractylodis Macrocephalae 10 parts, 15 parts, Fructus Jujubae, Caulis Perillae 9 parts, Massa Medicata Fermentata 8 parts, Pericarpium Citri Reticulatae 6 parts, Rhizoma Kaempferiae 4 parts, Ramulus Cinnamomi 4 parts, Flos Caryophylli 3 parts, the Radix Paeoniae Alba 3 parts.
3. pharmaceutical composition as claimed in claim 1 or 2, it is characterized in that, described pharmaceutical composition is oral formulations.
4. pharmaceutical composition as claimed in claim 3, it is characterized in that, described oral formulations is oral liquid, granule, electuary or powder.
5. pharmaceutical composition as claimed in claim 4, it is characterized in that, described oral formulations is granule.
6. prepare the method for pharmaceutical composition as claimed in claim 1 or 2 for one kind, it is characterized in that, after comprising the steps: that the raw material Radix Codonopsis of above-mentioned weight portion, the Rhizoma Atractylodis Macrocephalae, Fructus Jujubae, Caulis Perillae, Massa Medicata Fermentata, Pericarpium Citri Reticulatae, Rhizoma Kaempferiae, Ramulus Cinnamomi, Flos Caryophylli, the Radix Paeoniae Alba are ground into coarse powder, add the water of 5 times amount of coarse powder gross weight, decoct three times, be 1.5h at every turn, filter, when filtrate after merging is concentrated into 75 DEG C, its relative density is the thick paste of 1.30-1.34.
7. the purposes of pharmaceutical composition as claimed in claim 1 or 2 in preparation treatment functional dyspepsia medicine.
8. the purposes of pharmaceutical composition as claimed in claim 1 or 2 in preparation treatment spleen-stomach deficiency-cold functional dyspepsia medicine.
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| CN104815202A (en) * | 2015-04-12 | 2015-08-05 | 徐建 | Traditional Chinese medicine composition for treating functional dyspepsia spleen-stomach deficient cold syndrome |
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