CN104474204A - Pharmaceutical composition for treating infantile diarrhea - Google Patents
Pharmaceutical composition for treating infantile diarrhea Download PDFInfo
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- CN104474204A CN104474204A CN201410758676.7A CN201410758676A CN104474204A CN 104474204 A CN104474204 A CN 104474204A CN 201410758676 A CN201410758676 A CN 201410758676A CN 104474204 A CN104474204 A CN 104474204A
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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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- 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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/238—Saposhnikovia
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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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)
- A61K36/62—Nymphaeaceae (Water-lily family)
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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)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/884—Alismataceae (Water-plantain family)
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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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
- A61K2236/30—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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- 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
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
Abstract
The invention belongs to the technical field of medicines and particularly relates to a pharmaceutical composition for treating infantile diarrhea. The pharmaceutical composition comprises the following components: radix codonopsis, rhizoma discoreae, orange peel, fried rhizoma atractylodis macrocephalae, white hyacinth beans, radix saposhnikoviae, rhizoma alismatis, semen euryales, tuckahoe and liquorice. The pharmaceutical composition disclosed by the invention is prepared from Chinese herbal medicines and is exact in effect on treating infantile diarrhea caused by spleen deficiency, capable of simultaneously treating the symptoms and root causes and effectively healing a patient suffering from infantile diarrhea caused by spleen deficiency, and little in side effects; the preparation process is mature; raw materials are easily obtained; and the infantile diarrhea caused by spleen deficiency cannot relapse after being treated.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of pharmaceutical composition for the treatment of infantile diarrhea.
Background technology
Infantile diarrhea is equivalent to the Children's diarrhea vein of modern medicine, be a kind of by many cause of diseases, multifactor cause increase with times of defecation the digestive tract syndrome changing into feature with stool.
Infantile spleen deficiency is had loose bowels and belong to " infantile diarrhea " category in the traditional Chinese medical science, and in infantile diarrhea, occupies sizable ratio.The diarrhea due to hypofunction of the spleen often course of disease is long, and easily repeatedly, delay is difficult more, under causing infant body constitution gradually, easily causes malnutrition, rickets, anemia, hypoimmunity, dysplasia etc.Be cause infantile malnutrition, one of dysplasia and main causes of death, diarrhoeal diseases all can be fallen ill throughout the year, especially common with summer and autumn.
Doctor trained in Western medicine is many by killing or suppressing pathogen to be treated, and part infant is due to antibiotic abuse, and cause pathogen drug resistance and some side effects of pharmaceutical drugs, antibacterial effect is not satisfactory.Or owing to having a delicate constitution or feeling evil very grave, healthy energy is impaired, and body can not recover rapidly, or unable removing is remaining evil and cause protracted inflammation and with the passing of time do not heal, so that heresy is dispelled and transporting and transforming function of the spleen and stomach is unable, obstinate disease, and especially for a long time, chronic, intractable has loose bowels.The traditional Chinese medical science is by prescription, and give full play to the speciality of its determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, determined curative effect, side effect is little, has good therapeutic effect to diarrhea due to hypofunction of the spleen, so it is very necessary to study the have loose bowels Chinese medicine composition of disease of effective treatment infantile spleen deficiency type.
Summary of the invention
The invention provides a kind of new pharmaceutical composition for the treatment of infantile diarrhea, this pharmaceutical composition is rapid-action, good effect, and toxic and side effects is little, and it is obtained by following raw material: Radix Codonopsis, Rhizoma dioscoreae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis Macrocephalae (parched), Semen Lablab Album, Radix Saposhnikoviae, Rhizoma Alismatis, Semen Euryales, Poria, Radix Glycyrrhizae.
In pharmaceutical composition of the present invention, described Radix Codonopsis, sweet, flat.Return spleen, lung meridian.Invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst.
Rhizoma dioscoreae, sweet, flat.Return spleen, lung, kidney channel.Spleen reinforcing nourishing the stomach, promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.For insufficiency of the spleen lack of appetite, incessant chronic diarrhea, the deficiency of the lung is breathed with cough, emission due to deficiency of the kidney, leukorrhagia, frequent micturition, and deficiency-heat is quenched one's thirst.Rhizoma Dioscoreae (parched with bran) spleen reinforcing stomach invigorating.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, leukorrhagia.
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.
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.Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, frequent fetal movement.Rhizoma Atractylodis Macrocephalae (parched): be sprinkled into by processed with honey wheat bran in hot pot, add Rhizoma Atractylodis Macrocephalae sheet in time smoldering, fry to coke yellow, effusion burnt odor gas, take out, sieve removes processed with honey wheat bran.Every 100kg Rhizoma Atractylodis Macrocephalae sheet, with processed with honey wheat bran 10kg.
Semen Lablab Album, sweet, tepor.Return spleen, stomach warp.Invigorating the spleen for eliminating dampness, and in relieve summer heat.For weakness of the spleen and stomach, inappetence, diarrhea, leukorrhagia, heat-damp in summer is vomited and diarrhoea, abdominal distention uncomfortable in chest.
Radix Saposhnikoviae, acrid, sweet, warm.Return bladder, liver, spleen channel.Inducing diaphoresis to dispel wind, victory is wet, relieving convulsion.For headache due to common cold, rheumatic arthralgia, rubella pruritus, tetanus.
Rhizoma Alismatis, sweet, cold.Return kidney, urinary bladder channel.Diuresis, clearing away damp-heat.For dysuria, edema distension, oliguria of having loose bowels, dizziness due to fluid-retention, the puckery pain of pyretic stranguria; Hyperlipidemia.
Semen Euryales is sweet, puckery, flat.Return spleen, kidney channel.Supplementing the kidney to control the nocturnal, spleen reinforcing antidiarrheal, damp eliminating leukorrhagia stopping.For emission, enuresis frequent micturition, insufficiency of the spleen chronic diarrhea, nebulousurine, leukorrhagia.
Poria is sweet, light, flat.GUIXIN, lung, spleen, kidney channel.Promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
Radix Glycyrrhizae, sweet, flat.GUIXIN, lung, spleen, stomach warp.Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Infantile spleen deficiency type disease of having loose bowels is commonly encountered diseases, frequently-occurring disease.Control when invigorating the spleen and benefiting QI, hold up spleen to help fortune.The merit selecting Radix Codonopsis, Rhizoma dioscoreae to play invigorating the spleen and benefiting QI altogether in drug regimen object space of the present invention is monarch drug; Regulate the flow of vital energy stomach warming, dyspepsia and intestinal stasis relieving of Pericarpium Citri Reticulatae, Rhizoma Atractylodis Macrocephalae (parched) is ministerial drug; Semen Lablab Album, Radix Saposhnikoviae removing dampness reason spleen, Rhizoma Alismatis, Semen Euryales spleen reinforcing antidiarrheal are adjuvant drug; The invigorating the spleen to arrest diarrhea of Poria mind calming, Radix Glycyrrhizae spleen reinforcing is eliminating evil, coordinating the actions of various ingredients in a prescription, altogether for making medicine.The all medicines of we share, and eliminating evilly just not to hinder, are playing the merit of spleen invigorating mind calming, dyspepsia and intestinal stasis relieving, regulating QI to expel dampness altogether, reach and promote infant appetite, improve the simultaneous phenomenon such as the mental status, stool abnormity, spleen strong then can transporting strong, can to have loose bowels disease from basic infantile spleen deficiency type of curing.
The technical scheme adopted for solving its technical problem is the pharmaceutical composition that described treatment infantile spleen deficiency type is had loose bowels, be made up of the medicine material of following weight: Radix Codonopsis 15-25 part, Rhizoma dioscoreae 10-20 part, Pericarpium Citri Reticulatae 12-18 part, Rhizoma Atractylodis Macrocephalae (parched) 6-12 part, Semen Lablab Album 6-16 part, Radix Saposhnikoviae 8-12 part, Rhizoma Alismatis 5-10 part, Semen Euryales 1-5 part, Poria 3-6 part, Radix Glycyrrhizae 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 20 parts, Rhizoma dioscoreae 15 parts, Pericarpium Citri Reticulatae 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 9 parts, Semen Lablab Album 11 parts, Radix Saposhnikoviae 10 parts, Rhizoma Alismatis 8 parts, Semen Euryales 3 parts, 5 parts, Poria, 3 parts, Radix Glycyrrhizae.
Present invention also offers the preparation method of described pharmaceutical composition, specifically comprise the steps:
By the raw material Radix Codonopsis of above-mentioned weight portion, Rhizoma dioscoreae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis Macrocephalae (parched), Semen Lablab Album, Radix Saposhnikoviae, Rhizoma Alismatis, Semen Euryales, Poria, Radix Glycyrrhizae is ground into coarse powder respectively, mix homogeneously, adds after gross mass 3 times of water gagings first soak 30min and decocts 2 times, filter after each 30min, the determining alcohol adding filtrate equivalent is the alcohol reflux 2 times of 75%, and each 45min, filters, reclaim ethanol, filtrate is concentrated into thick paste, obtains final product.
Those skilled in the art directly can be used as medicine on obtained active constituents of medicine basis of the present invention to take 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.Therefore, in this pharmaceutical composition except effective ingredient, pharmaceutically acceptable adjuvant can also be contained.
Preferably, pharmaceutical composition of the present invention conveniently preparation technology be prepared into oral liquid, syrup, pill or powder etc.Use medicine composite for curing infantile spleen deficiency type of the present invention have loose bowels disease time, take prepared syrup or oral liquid, each 10mL medicinal liquid, 2 times on the one, every milliliter of syrup or oral liquid are containing crude drug amount 0.3g; Or take prepared powder, every bag contains crude drug amount 6g, each half bag, 2 times on the one; Or take prepared pill, every ball contains crude drug amount 1g, each 3,2 times on the one.
The present invention also asks the purposes protecting aforementioned pharmaceutical compositions to have loose bowels in medicine in preparation treatment infantile spleen deficiency type.
By after the safety evaluatio of pharmaceutical composition of the present invention, selecting clinical case to observe 70 known treated routine infantile spleen deficiency types and to have loose bowels infant, without coming off case in therapeutic process, all completing clinical observation.After two groups of infants treated for 2 courses for the treatment of, total effects compares, and treatment group cure rate is 60.0%, and matched group is 40.0%, and cure rate compares, and the equal < 0.05 of P value, has significant difference; Total effective rate treatment group is 94.3%, and matched group is 85.7%, and total effective rate compares, and the equal < 0.05 of P value, has significant difference.Without serious adverse reaction and those who are allergic to this drug in two groups of therapeutic processes.Result shows that treatment group cure rate and effective percentage are obviously better than matched group, has significant difference.Medicine composite for curing infantile spleen deficiency type of the present invention is used to have loose bowels determined curative effect, safe and reliable, can be used as the effective ways that treatment infantile spleen deficiency type is had loose bowels, be worth of widely use in clinical.Reach the object of spleen invigorating mind calming, dyspepsia and intestinal stasis relieving, regulating QI to expel dampness after thus pharmaceutical composition prescription of the present invention being described, serve the remarkable result for the treatment of both the principal and secondary aspects of a disease.
Pharmaceutical composition of the present invention is natural pure Chinese medicinal preparation, former medicine is easy to get, with low cost, follow the prescriptions principle of the traditional Chinese medical science, untoward reaction and side effect significantly reduce, and safety coefficient is high, verify through clinical practice, its 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 94%, can treat infantile spleen deficiency type preferably and have loose bowels.Medicine medication prepared by simultaneously the present invention is convenient, improves infantile spleen deficiency type and to have loose bowels the compliance of patient, improve the quality of life of 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 20 parts, Rhizoma dioscoreae 15 parts, Pericarpium Citri Reticulatae 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 9 parts, Semen Lablab Album 11 parts, Radix Saposhnikoviae 10 parts, Rhizoma Alismatis 8 parts, Semen Euryales 3 parts, 5 parts, Poria, 3 parts, Radix Glycyrrhizae by following weight portion.
Preparation technology: by the raw material Radix Codonopsis of above-mentioned weight portion, Rhizoma dioscoreae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis Macrocephalae (parched), Semen Lablab Album, Radix Saposhnikoviae, Rhizoma Alismatis, Semen Euryales, Poria, Radix Glycyrrhizae is ground into coarse powder respectively, mix homogeneously, adds after gross mass 3 times of water gagings first soak 30min and decocts 2 times, filter after each 30min, the determining alcohol adding filtrate equivalent is the alcohol reflux 2 times of 75%, each 45min, filter, reclaim ethanol, filtrate is concentrated into thick paste.Those skilled in the art directly can be used as medicine on obtained active constituents of medicine basis of the present invention to take or add on pharmaceutics acceptable adjuvant routinely technique obtain the conventional oral formulations such as oral liquid, syrup, pill or powder.
Use medicine composite for curing infantile spleen deficiency type of the present invention have loose bowels disease time, take prepared syrup or oral liquid, each 10mL medicinal liquid, 2 times on the one, every milliliter of syrup or oral liquid are containing crude drug amount 0.3g; Or take prepared powder, every bag contains crude drug amount 6g, each 3g, 2 times on the one; Or take prepared pill, every ball contains crude drug amount 1g, each 3 balls, 2 times on the one.
Embodiment 2
The each raw material of the present invention is taken: Radix Codonopsis 15 parts, Rhizoma dioscoreae 10 parts, Pericarpium Citri Reticulatae 12 parts, Rhizoma Atractylodis Macrocephalae (parched) 6 parts, Semen Lablab Album 6 parts, Radix Saposhnikoviae 8 parts, Rhizoma Alismatis 5 parts, Semen Euryales 1 part, 3 parts, Poria, 1 part, Radix Glycyrrhizae by following weight portion.
Embodiment 3
The each raw material of the present invention is taken: Radix Codonopsis 25 parts, Rhizoma dioscoreae 20 parts, Pericarpium Citri Reticulatae 18 parts, Rhizoma Atractylodis Macrocephalae (parched) 12 parts, Semen Lablab Album 16 parts, Radix Saposhnikoviae 12 parts, Rhizoma Alismatis 10 parts, Semen Euryales 5 parts, 6 parts, Poria, 5 parts, Radix Glycyrrhizae by following weight portion.
Embodiment 4
The each raw material of the present invention is taken: Radix Codonopsis 15 parts, Rhizoma dioscoreae 20 parts, Pericarpium Citri Reticulatae 12 parts, Rhizoma Atractylodis Macrocephalae (parched) 12 parts, Semen Lablab Album 6 parts, Radix Saposhnikoviae 12 parts, Rhizoma Alismatis 5 parts, Semen Euryales 5 parts, 3 parts, Poria, 5 parts, Radix Glycyrrhizae by following weight portion.
Embodiment 5
The each raw material of the present invention is taken: Radix Codonopsis 25 parts, Rhizoma dioscoreae 10 parts, Pericarpium Citri Reticulatae 18 parts, Rhizoma Atractylodis Macrocephalae (parched) 6 parts, Semen Lablab Album 16 parts, Radix Saposhnikoviae 8 parts, Rhizoma Alismatis 10 parts, Semen Euryales 1 part, 6 parts, Poria, 1 part, Radix Glycyrrhizae by following weight portion.
The preparation technology of embodiment 2-5 is with embodiment 1.
Embodiment 6 medicine composite for curing infantile spleen deficiency of the present invention type is had loose bowels the clinical observation of disease
1, case-data: select the infantile spleen deficiency type meeting inclusive criteria of pediatric hospital ward and outpatient clinic to have loose bowels infant 70 example.The method of employing random packet, parallel control is studied.
Institute includes in the object of observation, treatment group: 35 examples, wherein man 20 example, female 15 example, 8 months-5 years old age.Matched group: 35 examples, wherein man 21 example, female 14 example, 7 months-5 years old age.Two groups of sexes, ages etc. through statistical procedures through statistical procedures, compare there was no significant difference (P>0.05), have comparability.
2, diagnosis basis:
1) Western medicine diagnose standard:
According to 2002 " practical paidonosology " the 7th edition formulate with the course of disease more than 2 weeks, times of defecation is more, every day more than 3 times, and with the change of stool amount or character, (stool amount is many, mostly be just shapeless), the visible non-digest food of stool routine examination inspection or a small amount of fat drop.
2) tcm diagnosis standard:
Times of defecation increases, every day 3-5 time, and nearly more than 10 times, in faint yellow, as egg soup sample, or color is brown and smelly, can have a small amount of mucus.Or with feel sick, vomiting, stomachache, heating, thirsty wait disease.There is excess in feeding, unhygienic diet or experience the medical history of seasonal pathogen.Diarrhoea or vomiting more severe case, the diseases such as visible oliguria, excessive thirst, body temperature raise, skin shrivelled, chimney door depression, order pearl are sunk, crying without tears, breathing are profound, abdominal distention.Stool microscopy can have Oil globule, or a small amount of red white corpuscle.The growths such as the visible Escherichia coli of stool pathogenic examination, or isolate rotavirus etc.Severe diarrhea can with dehydration, acid base imbalance and electrolyte disturbance.
3) TCM syndrome diagnostic criteria of syndrome of spleen-deficiency:
Primary symptom: for a long time thirsty more than, or recurrent exerbation, thirsty more than doing after food, time light time heavy, soft stools, or in water sample, color is light not smelly, with milk lobe or indigestion food residues.
Secondary disease: tired, lustreless complexion, emaciated physique, light red tongne, greasy and thin fur, weak pulse is unable.
3, inclusive criteria:
(1) primary disease tcm diagnosis standard person is met;
(2) the syndrome of spleen-deficiency person in primary disease tcm syndrome standard is met;
(3) 6 months-5 years old age, mature newborn baby;
(4) stool routine examination can be shown in red, leukocyte and Oil globule a little;
(5) the experimenter guardian person that signs Informed Consent Form.
4, exclusion standard:
(1) intestinal parasitical diseases, bacillary dysentery, amebic dysentery, cholera etc.;
(2) other diarrhoea caused by system infections disease is merged, as pneumonia etc.;
(3) infant of the diseases such as severe cardiac, brain, liver, kidney and hematopathy is associated with;
(4) 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, and to affect the treatment or safety judgement person.
6, usage and dosage:
Treatment group: oral liquid prepared by Example 1, each serving using 10mL medicinal liquid, 2 times on the one, every milliliter of oral liquid is containing crude drug amount 0.3g.
Matched group: bacillus bifidus live triple falls apart (Birid Triple Viable, the accurate word S10970104 of traditional Chinese medicines), oral, with warm water; Middle clothes.0-1 year child, once half bag; 1-5 year child, one time 1 bag; More than 6 years old children and adults, one time 2 bag; 3 times on the one.
Within 14 days, be 1 course for the treatment of, two groups were all used in conjunction for 2 courses for the treatment of.
7, efficacy evaluation:
(1) cure: stool is shaped, General Symptoms disappears.Stool microscopy is without exception, and etiological examination is negative.
(2) take a turn for the better: times of defecation and moisture content reduce, and General Symptoms improves.Stool microscopy Oil globule or red, leukocyte is accidental.
(3) do not heal: times of defecation and moisture content do not improve, or exacerbation of symptoms.
8, therapeutic effect:
Without coming off case in therapeutic process, all complete clinical observation.After two groups of infants treated for 2 courses for the treatment of, total effects compares, and treatment group cure rate is 60.0%, and matched group is 40.0%, and cure rate compares, and the equal < 0.05 of P value, has significant difference; Total effective rate treatment group is 94.3%, and matched group is 85.7%, and total effective rate compares, and the equal < 0.05 of P value, there were significant differences.
The comparitive study of table 1. treatment group and matched group
Without serious adverse reaction and those who are allergic to this drug in two groups of therapeutic processes.Result shows that treatment group cure rate and effective percentage are obviously better than matched group, has significant difference.Medicine composite for curing infantile spleen deficiency type of the present invention is used to have loose bowels determined curative effect, safe and reliable, can be used as the effective ways that treatment infantile spleen deficiency type is had loose bowels, be worth of widely use in clinical.
Claims (7)
1. treat the pharmaceutical composition of infantile diarrhea for one kind, it is characterized in that, it obtains primarily of the raw material of following weight portion: Radix Codonopsis 15-25 part, Rhizoma dioscoreae 10-20 part, Pericarpium Citri Reticulatae 12-18 part, Rhizoma Atractylodis Macrocephalae (parched) 6-12 part, Semen Lablab Album 6-16 part, Radix Saposhnikoviae 8-12 part, Rhizoma Alismatis 5-10 part, Semen Euryales 1-5 part, Poria 3-6 part, Radix Glycyrrhizae 1-5 part.
2. pharmaceutical composition as claimed in claim 1, is characterized in that, it obtains primarily of the raw material of following weight portion: Radix Codonopsis 20 parts, Rhizoma dioscoreae 15 parts, Pericarpium Citri Reticulatae 15 parts, Rhizoma Atractylodis Macrocephalae (parched) 9 parts, Semen Lablab Album 11 parts, Radix Saposhnikoviae 10 parts, Rhizoma Alismatis 8 parts, Semen Euryales 3 parts, 5 parts, Poria, 3 parts, Radix Glycyrrhizae.
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, syrup, pill, granule or powder.
5. pharmaceutical composition as claimed in claim 4, it is characterized in that, described oral formulations is oral liquid.
6. prepare a method for pharmaceutical composition as claimed in claim 3, it is characterized in that, comprise the steps: the raw material Radix Codonopsis of above-mentioned weight portion, Rhizoma dioscoreae, Pericarpium Citri Reticulatae, Rhizoma Atractylodis Macrocephalae (parched), Semen Lablab Album, Radix Saposhnikoviae, Rhizoma Alismatis, Semen Euryales, Poria, Radix Glycyrrhizae is ground into coarse powder respectively, mix homogeneously, adds after gross mass 3 times of water gagings first soak 30min and decocts 2 times, filter after each 30min, the determining alcohol adding filtrate equivalent is the alcohol reflux 2 times of 75%, each 45min, filters, and reclaims ethanol, filtrate is concentrated into thick paste, obtains final product.
7. pharmaceutical composition as claimed in claim 1 or 2 is preparing the purposes for the treatment of infantile spleen deficiency type and having loose bowels in medicine.
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| CN104906316A (en) * | 2015-06-19 | 2015-09-16 | 韦木兰 | Tablets for strengthening the spleen and clearing away dampness and preparation method thereof |
| CN104906315A (en) * | 2015-06-19 | 2015-09-16 | 韦木兰 | Chinese herbal medicine preparation with effects of tonifying spleens and eliminating dampness and preparation method of Chinese herbal medicine preparation |
| CN113633731A (en) * | 2021-08-12 | 2021-11-12 | 哈尔滨珍宝制药有限公司 | Traditional Chinese medicine composition for treating infantile spleen deficiency diarrhea and preparation method and application thereof |
| CN115553418A (en) * | 2022-09-29 | 2023-01-03 | 泸州肥儿粉股份有限公司 | Complementary food for conditioning diarrhea and preparation method thereof |
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| CN104906316A (en) * | 2015-06-19 | 2015-09-16 | 韦木兰 | Tablets for strengthening the spleen and clearing away dampness and preparation method thereof |
| CN104906315A (en) * | 2015-06-19 | 2015-09-16 | 韦木兰 | Chinese herbal medicine preparation with effects of tonifying spleens and eliminating dampness and preparation method of Chinese herbal medicine preparation |
| CN113633731A (en) * | 2021-08-12 | 2021-11-12 | 哈尔滨珍宝制药有限公司 | Traditional Chinese medicine composition for treating infantile spleen deficiency diarrhea and preparation method and application thereof |
| CN115553418A (en) * | 2022-09-29 | 2023-01-03 | 泸州肥儿粉股份有限公司 | Complementary food for conditioning diarrhea and preparation method thereof |
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Application publication date: 20150401 |