CN104435247A - Pharmaceutical composition for treating indigestion - Google Patents

Pharmaceutical composition for treating indigestion Download PDF

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Publication number
CN104435247A
CN104435247A CN201410619642.XA CN201410619642A CN104435247A CN 104435247 A CN104435247 A CN 104435247A CN 201410619642 A CN201410619642 A CN 201410619642A CN 104435247 A CN104435247 A CN 104435247A
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China
Prior art keywords
pharmaceutical composition
parts
endothelium corneum
gigeriae galli
corneum gigeriae
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李文军
成建国
张太君
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CHENGDU GUORUI PHARMACEUTICAL TECHNOLOGY Co Ltd
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CHENGDU GUORUI PHARMACEUTICAL TECHNOLOGY Co Ltd
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Publication of CN104435247A publication Critical patent/CN104435247A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258Panax (ginseng)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/57Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/47Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/62Nymphaeaceae (Water-lily family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/55Liquid-liquid separation; Phase separation

Abstract

The invention discloses a pharmaceutical composition for treating indigestion. The pharmaceutical composition is prepared from ginseng, endothelium corneum gigeriae galli, dried tangerine peel, emblic leafflower fruits, lotus leaves and glycyrrhiza uralensis. The pharmaceutical composition can be used for strengthening the spleen and harmonizing the stomach and promoting digestion, can also be used for promoting digestion and stopping diarrhea, and particularly has a definite treatment effect on anorexia and indigestion resulting from the Yin deficiency of the spleen and stomach.

Description

Treat dyspeptic pharmaceutical composition
Technical field
The present invention relates to one and treat dyspeptic pharmaceutical composition, particularly a kind of is the pharmaceutical composition that raw material is made by Radix Ginseng, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Phyllanthi, Folium Nelumbinis and Radix Glycyrrhizae.
Background technology
Dyspepsia is a kind of common internal medicine digestive system disease, morbidity crowd is many, its symptom main manifestations is for having epigastric discomfort or pain, glutted, heartburn (acid regurgitation), belch by spells, often be reluctant to take food or take food less as far as possible because satisfy uncomfortable in chest, morning sense, abdominal distention etc. are uncomfortable, also be difficult to sleep peacefully at night, normal with nightmare after sleeping.Also have some patient's abdominal distention obvious, abdominal part borborygmus, aerofluxus increases, even the indigested food debris of Chang Kejian in stool.
The Western medicine huge number of current treatment dyspepsia disease, as motilium, metoclopramide etc., although instant effect, good effect, but there is certain side effect, Chinese medicine is little with its toxic and side effects, the occupancy volume of the market share expands year by year, but usually there is the problems such as curative effect is rapid not, effective ingredient is not obvious, medication dose is large.
Summary of the invention
The object of the invention is to overcome above-mentioned deficiency existing in prior art, provide one to treat dyspeptic pharmaceutical composition.This pharmaceutical composition effectively can treat dyspepsia, instant effect, and dosage is little, has no side effect.
In order to realize foregoing invention object, the invention provides following technical scheme:
The dyspeptic pharmaceutical composition for the treatment of of the present invention, it is the medicament be made up of following raw material: Radix Ginseng, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Phyllanthi, Folium Nelumbinis and Radix Glycyrrhizae.
In pharmaceutical composition of the present invention, Radix Ginseng is flat, sweet in the mouth, micro-hardship, and tepor returns spleen channel, lung meridian, has strongly invigorating primordial QI, and multiple arteries and veins takes off admittedly, invigorating the spleen to benefit the lung, promoting the production of body fluid to quench thirst, Fructus Alpiniae Oxyphyllae of calming the nerves.
Endothelium Corneum Gigeriae Galli, sweet in the mouth, property is put down.Return spleen, stomach, small intestinal, urinary bladder channel.Function: strengthening the spleen to promote digestion; Arresting seminal emission; Xiao Disorder fossil.Cure mainly: dyspepsia; Eating accumulation; Vomiting regurgitation; To have loose bowels dysentery; Infantile malnutrition; Seminal emission; The enuresis; Frequent micturition; Urinary system calculus and cholelithiasis; Mass in the abdomen amenorrhea; Sore throat tonsillitis; Ulcerative gingivitis aphtha.
Pericarpium Citri Reticulatae, nature and flavor are bitter, pungent, and temperature, returns 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.
Fructus Phyllanthi, bitter but sweet flavor, cold in nature.Attach to the lung and stomach meridians.Relieving sore-throat by clearing away heat, moistening the lung and resolving phlegm, promoting the production of body fluid to quench thirst." Traditional Chinese Medicine in Sichuan will ": " enter spleen, stomach paralysis is reduced phlegm, and promotes the production of body fluid, cough-relieving, removing toxic substances.Cure cold heating, cough pharyngalgia, diphtheria, restlessness and fever with thirst.”
Folium Nelumbinis, bitter but sweet flavor, property is put down, GUIXIN, Liver Channel.Delicate fragrance rises loose effect with the expelling summer-heat that clears away heart-fire, dissipating blood stasis hemostasis, pathogenic wind expelling damp eliminating.Cure mainly summer-heat excessive thirst, pediatric epilepsy scared, the inverse stupor of married woman's blood, gets injured by a fall hematemesis, menoxenia, metrorrhagia, eczema scabies.
Radix Glycyrrhizae, nature and flavor are sweet, flat, and GUIXIN, lung, spleen, stomach warp, have QI invigorating invigorating middle warmer, the function of heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, the mediation property of medicine.
Applicant finds through test of many times, is that pharmaceutical composition made by raw material, effectively can treats indigestion by Radix Ginseng, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Phyllanthi, Folium Nelumbinis and Radix Glycyrrhizae.
Preferably, described pharmaceutical composition is made up of the raw material of following weight: Radix Ginseng 1 ~ 20 part, Endothelium Corneum Gigeriae Galli 2 ~ 18 parts, Pericarpium Citri Reticulatae 1 ~ 22 part, Fructus Phyllanthi 1 ~ 15 part, 2 ~ 10 parts, Folium Nelumbinis and 1 ~ 8 part, Radix Glycyrrhizae.
Applicant finds through many experiments, and pharmaceutical composition of the present invention is made up of the raw material of above-mentioned weight, better can play the synergistic function of each raw material components, not only effectively can treat indigestion, instant effect simultaneously, dosage is little, has no side effect.
Further preferably, described pharmaceutical composition is made up of the raw material of following weight: Radix Ginseng 1 ~ 15 part, Endothelium Corneum Gigeriae Galli 2 ~ 15 parts, Pericarpium Citri Reticulatae 1 ~ 18 part, Fructus Phyllanthi 2 ~ 12 parts, 3 ~ 10 parts, Folium Nelumbinis and 1 ~ 5 part, Radix Glycyrrhizae.
Still more preferably, described pharmaceutical composition is made up of the raw material of following weight: Radix Ginseng 1 ~ 10 part, Endothelium Corneum Gigeriae Galli 4 ~ 10 parts, Pericarpium Citri Reticulatae 5 ~ 12 parts, Fructus Phyllanthi 3 ~ 7 parts, 3 ~ 6 parts, Folium Nelumbinis and 2 ~ 3 parts, Radix Glycyrrhizae.
Preferably, to the best described pharmaceutical composition be made up of the raw material of following weight: Radix Ginseng 5 parts, Endothelium Corneum Gigeriae Galli 6 parts, Pericarpium Citri Reticulatae 6 parts, Fructus Phyllanthi 6 parts, 6 parts, Folium Nelumbinis and 3 parts, Radix Glycyrrhizae.
By preferably above, the curative effect of pharmaceutical composition can be improved further.
The dosage form of pharmaceutical composition of the present invention can be the existing pharmaceutical dosage form of any one in drop pill, tablet, capsule, soft capsule, granule.
The preparation method of pharmaceutical composition of the present invention is as follows:
(1) get Radix Ginseng, add the ethanol of 8-10 times of volume or water extraction 3 times, each 1.5-2h, collect merge extractive liquid, and concentrated, in extracting solution after concentration, thin up, staticly settles, and filters, gets supernatant concentration and become rare extractum; Above-mentioned rare extractum is crossed macroporous adsorbent resin, and first with the low-concentration ethanol eluting of water or 1-20%, removing is dissolved in the impurity of polar solvent, is discarded by the eluent of this water or low-concentration ethanol; Use the high concentration ethanol eluting of 40-95% again, collect this high concentration ethanol eluent, by dry for the eluent reclaimed after ethanol, obtain Radix Ginseng extract.
(2) get Endothelium Corneum Gigeriae Galli, rub, add 6-10 times of volume water, regulate pH to 12 with 40%NaOH, 50 DEG C of heating 3h, collecting by filtration filtrate, repeats above operation 1 time to filtering residue, collects filtrate and merge.The hydrochloric acid of the filtrate 2mol/L after merging adjusts pH to 4, centrifugal, obtains precipitation.Precipitate is again with ether or dehydrated alcohol dehydration, and natural drying 48h, obtains Endothelium Corneum Gigeriae Galli extract.
(3) get Pericarpium Citri Reticulatae, rub, add the water of 5 times of volumes, soak 1h, filter, in filtering residue, add the saturated Ca (OH) of 8-10 times of volume 2solution, stir after extracting 2h and filter, the hydrochloric acid solution with 10% regulates filtrate pH value to 4.5, and be incubated crystallization 1h at 70 DEG C, spend the night after cooling, filter to obtain crystallization, drying crystalline, to constant weight, obtains Pericarpium Citri Reticulatae extract.
(4) get Fructus Phyllanthi, add the water reflux, extract, 10 hours of 8-12 times of volume, collect extracting solution, concentrated, dry, obtain Fructus Phyllanthi extract.
(5) get Folium Nelumbinis, add ethanol 55 DEG C of lixiviates 3 times of 75% of 8-10 times of volume, each 1.5 hours.Collect merge extractive liquid, and concentrate, dry, obtain Folium Nelumbinis extract.
(6) extracting liquorice, adds the water boiling and extraction 2 times of 8-10 times of volume, each 1.5-2h, merge extractive liquid, concentrated, dry, obtains Radix Glycyrrhizae extract.
(7) Radix Ginseng, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Phyllanthi, Folium Nelumbinis and Radix Glycyrrhizae extract are mixed, make acceptable various pharmaceutical dosage form.
Preparation method of the present invention effectively can extract the effective ingredient in each crude drug, makes it better play the effect of Synergistic.
The present invention's various raw medicinal materials used are the Chinese crude drug meeting country or provincial standard and specify.The dyspeptic pharmaceutical composition for the treatment of of the present invention, based on theory of Chinese medical science, in conjunction with clinical practice, filter out from Chinese medicine material treasure-house and there is invigorating the stomach and promoting digestion, invigorating the spleen and benefiting QI, regulating QI to relieve pain, digestive pure purification of tcm forms, and regulate the weight of each raw material, make the effect playing Synergistic between each raw material, can latent heat in clearing stomach, let out the fire of liver taste, adjust liver QI of the spleen and stomach, the abdominal discomfort that treatment dyspepsia is caused or pain, glutted, heartburn (acid regurgitation), the symptoms such as belch have significant curative effect, effective treatment rate reaches more than 90%.Pharmaceutical composition instant effect of the present invention simultaneously, dosage is little, has no side effect.
Detailed description of the invention
Below in conjunction with test example and detailed description of the invention, the present invention is described in further detail.But this should be interpreted as that the scope of the above-mentioned theme of the present invention is only limitted to following embodiment, all technology realized based on content of the present invention all belong to scope of the present invention.
Embodiment 1
The dyspeptic pharmaceutical composition for the treatment of described in the present embodiment, be made up of the raw material of following weight:
Radix Ginseng 5g, Endothelium Corneum Gigeriae Galli 6g, Pericarpium Citri Reticulatae 6g, Fructus Phyllanthi 6g, Folium Nelumbinis 6g and Radix Glycyrrhizae 3g.
Above-mentioned raw materials is prepared into capsule, and preparation method is as follows:
(1) get Radix Ginseng, add the ethanol of 8 times of volumes or water extraction 3 times, each 1.5h, collect merge extractive liquid, and concentrated, in extracting solution after concentration, thin up, staticly settles, and filters, gets supernatant concentration and become rare extractum; Above-mentioned rare extractum is crossed macroporous adsorbent resin, first with water or 10% low-concentration ethanol eluting, removing is dissolved in the impurity of polar solvent, is discarded by the eluent of this water or low-concentration ethanol; Use the high concentration ethanol eluting of 60% again, collect this high concentration ethanol eluent, by dry for the eluent reclaimed after ethanol, obtain Radix Ginseng extract.
(2) get Endothelium Corneum Gigeriae Galli, rub, add 10 times of volume water, regulate pH to 12 with 40%NaOH, 50 DEG C of heating 3h, collecting by filtration filtrate, repeats above operation 1 time to filtering residue, collects filtrate and merge.The hydrochloric acid of the filtrate 2mol/L after merging adjusts pH to 4, centrifugal, obtains precipitation.Precipitate is again with ether or dehydrated alcohol dehydration, and natural drying 48h, obtains Endothelium Corneum Gigeriae Galli extract.
(3) get Pericarpium Citri Reticulatae, rub, add the water of 5 times of volumes, soak 1h, filter, in filtering residue, add the saturated Ca (OH) of 8 times of volumes 2solution, stir after extracting 2h and filter, the hydrochloric acid solution with 10% regulates filtrate pH value to 4.5, and be incubated crystallization 1h at 70 DEG C, spend the night after cooling, filter to obtain crystallization, drying crystalline, to constant weight, obtains Pericarpium Citri Reticulatae extract.
(4) get Fructus Phyllanthi, add the water reflux, extract, 10 hours of 12 times of volumes, collect extracting solution, concentrated, dry, obtain Fructus Phyllanthi extract.
(5) get Folium Nelumbinis, add ethanol 55 DEG C of lixiviates 3 times of 75% of 8 times of volumes, each 1.5 hours.Collect merge extractive liquid, and concentrate, dry, obtain Folium Nelumbinis extract.
(6) extracting liquorice, adds the water boiling and extraction 2 times of 10 times of volumes, each 1.5h, merge extractive liquid, concentrated, dry, obtains Radix Glycyrrhizae extract.
(7) by Radix Ginseng, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Phyllanthi, Folium Nelumbinis and Radix Glycyrrhizae extract mix homogeneously.
(8) said mixture is mixed homogeneously with starch 80g, adopt capsules preparation technique, the pharmaceutical composition of obtained capsule.
Embodiment 2
The dyspeptic pharmaceutical composition for the treatment of described in the present embodiment, be made up of the raw material of following weight:
Radix Ginseng 1g, Endothelium Corneum Gigeriae Galli 18g, Pericarpium Citri Reticulatae 22g, Fructus Phyllanthi 1g, Folium Nelumbinis 2g and Radix Glycyrrhizae 8g.
Above-mentioned raw materials is prepared into tablet, and preparation method is as follows:
(1) get Radix Ginseng, add the ethanol of 8 times of volumes or water extraction 3 times, each 2h, collect merge extractive liquid, and concentrated, in extracting solution after concentration, thin up, staticly settles, and filters, gets supernatant concentration and become rare extractum; Above-mentioned rare extractum is crossed macroporous adsorbent resin, first with water or 20% low-concentration ethanol eluting, removing is dissolved in the impurity of polar solvent, is discarded by the eluent of this water or low-concentration ethanol; Use the high concentration ethanol eluting of 95% again, collect this high concentration ethanol eluent, by dry for the eluent reclaimed after ethanol, obtain Radix Ginseng extract.
(2) get Endothelium Corneum Gigeriae Galli, rub, add 6 times of volume water, regulate pH to 12 with 40%NaOH, 50 DEG C of heating 3h, collecting by filtration filtrate, repeats above operation 1 time to filtering residue, collects filtrate and merge.The hydrochloric acid of the filtrate 2mol/L after merging adjusts pH to 4, centrifugal, obtains precipitation.Precipitate is again with ether or dehydrated alcohol dehydration, and natural drying 48h, obtains Endothelium Corneum Gigeriae Galli extract.
(3) get Pericarpium Citri Reticulatae, rub, add the water of 5 times of volumes, soak 1h, filter, in filtering residue, add the saturated Ca (OH) of 10 times of volumes 2solution, stir after extracting 2h and filter, the hydrochloric acid solution with 10% regulates filtrate pH value to 4.5, and be incubated crystallization 1h at 70 DEG C, spend the night after cooling, filter to obtain crystallization, drying crystalline, to constant weight, obtains Pericarpium Citri Reticulatae extract.
(4) get Fructus Phyllanthi, add the water reflux, extract, 10 hours of 8 times of volumes, collect extracting solution, concentrated, dry, obtain Fructus Phyllanthi extract.
(5) get Folium Nelumbinis, add ethanol 55 DEG C of lixiviates 3 times of 75% of 10 times of volumes, each 1.5 hours.Collect merge extractive liquid, and concentrate, dry, obtain Folium Nelumbinis extract.
(6) extracting liquorice, adds the water boiling and extraction 2 times of 8 times of volumes, each 2h, merge extractive liquid, concentrated, dry, obtains Radix Glycyrrhizae extract.
(7) by Radix Ginseng, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Phyllanthi, Folium Nelumbinis and Radix Glycyrrhizae extract mix homogeneously.
(8) by said mixture and 200g starch, 20g polyvidone mixes, and adopts existing pressed-disc technique, the pharmaceutical composition of obtained tablet.
Embodiment 3
The dyspeptic pharmaceutical composition for the treatment of described in the present embodiment, be made up of the raw material of following weight:
Radix Ginseng 20g, Endothelium Corneum Gigeriae Galli 2g, Pericarpium Citri Reticulatae 1g, Fructus Phyllanthi 15g, Folium Nelumbinis 10g and Radix Glycyrrhizae 1g.
Above-mentioned raw materials is prepared into soft capsule, and preparation method is as follows:
(1) get Radix Ginseng, add the ethanol of 10 times of volumes or water extraction 3 times, each 1.5h, collect merge extractive liquid, and concentrated, in extracting solution after concentration, thin up, staticly settles, and filters, gets supernatant concentration and become rare extractum; Above-mentioned rare extractum is crossed macroporous adsorbent resin, first with water or 10% low-concentration ethanol eluting, removing is dissolved in the impurity of polar solvent, is discarded by the eluent of this water or low-concentration ethanol; Use the high concentration ethanol eluting of 65% again, collect this high concentration ethanol eluent, by dry for the eluent reclaimed after ethanol, obtain Radix Ginseng extract.
(2) get Endothelium Corneum Gigeriae Galli, rub, add 6 times of volume water, regulate pH to 12 with 40%NaOH, 50 DEG C of heating 3h, collecting by filtration filtrate, repeats above operation 1 time to filtering residue, collects filtrate and merge.The hydrochloric acid of the filtrate 2mol/L after merging adjusts pH to 4, centrifugal, obtains precipitation.Precipitate is again with ether or dehydrated alcohol dehydration, and natural drying 48h, obtains Endothelium Corneum Gigeriae Galli extract.
(3) get Pericarpium Citri Reticulatae, rub, add the water of 5 times of volumes, soak 1h, filter, in filtering residue, add the saturated Ca (OH) of 8 times of volumes 2solution, stir after extracting 2h and filter, the hydrochloric acid solution with 10% regulates filtrate pH value to 4.5, and be incubated crystallization 1h at 70 DEG C, spend the night after cooling, filter to obtain crystallization, drying crystalline, to constant weight, obtains Pericarpium Citri Reticulatae extract.
(4) get Fructus Phyllanthi, add the water reflux, extract, 10 hours of 12 times of volumes, collect extracting solution, concentrated, dry, obtain Fructus Phyllanthi extract.
(5) get Folium Nelumbinis, add ethanol 55 DEG C of lixiviates 3 times of 75% of 8 times of volumes, each 1.5 hours.Collect merge extractive liquid, and concentrate, dry, obtain Folium Nelumbinis extract.
(6) extracting liquorice, adds the water boiling and extraction 2 times of 10 times of volumes, each 2h, merge extractive liquid, concentrated, dry, obtains Radix Glycyrrhizae extract.
(7) by Radix Ginseng, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Phyllanthi, Folium Nelumbinis and Radix Glycyrrhizae extract mix homogeneously.
(8) by said mixture and vegetable oil 25g, mixing, does capsule casing material with ' Yanming ' capsules for clearing, adopts existing soft capsule preparation technology, be pressed into soft capsule.
Embodiment 4
The dyspeptic pharmaceutical composition for the treatment of described in the present embodiment, be made up of the raw material of following weight:
Radix Ginseng 10g, Endothelium Corneum Gigeriae Galli 15g, Pericarpium Citri Reticulatae 17g, Fructus Phyllanthi 10g, Folium Nelumbinis 8g and Radix Glycyrrhizae 6g.
Above-mentioned raw materials is prepared into tablet, and preparation method is as follows:
(1) get Radix Ginseng, add the ethanol of 10 times of volumes or water extraction 3 times, each 2h, collect merge extractive liquid, and concentrated, in extracting solution after concentration, thin up, staticly settles, and filters, gets supernatant concentration and become rare extractum; Above-mentioned rare extractum is crossed macroporous adsorbent resin, first with water or 20% low-concentration ethanol eluting, removing is dissolved in the impurity of polar solvent, is discarded by the eluent of this water or low-concentration ethanol; Use the high concentration ethanol eluting of 55% again, collect this high concentration ethanol eluent, by dry for the eluent reclaimed after ethanol, obtain Radix Ginseng extract.
(2) get Endothelium Corneum Gigeriae Galli, rub, add 8 times of volume water, regulate pH to 12 with 40%NaOH, 50 DEG C of heating 3h, collecting by filtration filtrate, repeats above operation 1 time to filtering residue, collects filtrate and merge.The hydrochloric acid of the filtrate 2mol/L after merging adjusts pH to 4, centrifugal, obtains precipitation.Precipitate is again with ether or dehydrated alcohol dehydration, and natural drying 48h, obtains Endothelium Corneum Gigeriae Galli extract.
(3) get Pericarpium Citri Reticulatae, rub, add the water of 5 times of volumes, soak 1h, filter, in filtering residue, add the saturated Ca (OH) of 9 times of volumes 2solution, stir after extracting 2h and filter, the hydrochloric acid solution with 10% regulates filtrate pH value to 4.5, and be incubated crystallization 1h at 70 DEG C, spend the night after cooling, filter to obtain crystallization, drying crystalline, to constant weight, obtains Pericarpium Citri Reticulatae extract.
(4) get Fructus Phyllanthi, add the water reflux, extract, 10 hours of 9 times of volumes, collect extracting solution, concentrated, dry, obtain Fructus Phyllanthi extract.
(5) get Folium Nelumbinis, add ethanol 55 DEG C of lixiviates 3 times of 75% of 9 times of volumes, each 1.5 hours.Collect merge extractive liquid, and concentrate, dry, obtain Folium Nelumbinis extract.
(6) extracting liquorice, adds the water boiling and extraction 2 times of 9 times of volumes, each 2h, merge extractive liquid, concentrated, dry, obtains Radix Glycyrrhizae extract.
(7) by Radix Ginseng, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Phyllanthi, Folium Nelumbinis and Radix Glycyrrhizae extract mix homogeneously.
(8) by said mixture and 100g starch, 20g polyvidone mixes, and adopts existing pressed-disc technique, obtained tablet.
Comparative example 1
The dyspeptic pharmaceutical composition for the treatment of described in this comparative example, be made up of the raw material of following weight:
Radix Ginseng 5g, Endothelium Corneum Gigeriae Galli 6g, Pericarpium Citri Reticulatae 6g, Folium Nelumbinis 6g and Radix Glycyrrhizae 3g.
Adopt the preparation method described in embodiment 1, make the pharmaceutical composition of capsule.
Comparative example 2
The dyspeptic pharmaceutical composition for the treatment of described in the present embodiment, be made up of the raw material of following weight:
Radix Ginseng 5g, Pericarpium Citri Reticulatae 6g, Fructus Phyllanthi 6g and Radix Glycyrrhizae 3g.
Adopt the preparation method described in embodiment 1, make the pharmaceutical composition of capsule.
Embodiment 5
The curative effect of pharmaceutical composition of the present invention and advantage thereof are by following clinical trial certificate:
1, Subject Population:
Be divided into A, B, C tri-experimental grouies by disease symptom, group result is as described in Table 1:
Table 1 patient group result
2, efficacy result evaluation
(1) pharmaceutical composition of the present invention is to the therapeutic outcome of A group patient
A group patient is equally divided into six groups (a ~ f groups), often organizes 50 people.Give pharmaceutical composition prepared by six groups of oral embodiment of the present invention 1 ~ 4 of patient and comparative example 1 ~ 2 respectively, every day is early, middle and late respectively to be taken 2 (sheets) after meal, and serve on 5 days, accumulated dose of taking medicine is 0.73g raw medicinal herbs/kg every day.
Efficacy evaluation: symptom is invalid without alleviation or DeGrain; Symptom substantially disappears or disappears completely is effective, and the therapeutic effect of medicine of the present invention to A group patient is as shown in table 2.
Table 2 pharmaceutical composition of the present invention is to the therapeutic outcome of A group patient
(2) pharmaceutical composition of the present invention is to the therapeutic outcome of B group patient
B group patient is equally divided into six groups (a ~ f groups), often organizes 50 people.Give pharmaceutical composition prepared by six groups of oral embodiment of the present invention 1 ~ 4 of patient and comparative example 1 ~ 2 respectively, every day is early, middle and late respectively to be taken 2 (sheets) after meal, and serve on 5 days, accumulated dose of taking medicine is 0.73g raw medicinal herbs/kg every day.
Efficacy evaluation: symptom is invalid without alleviation or DeGrain; Symptom substantially disappears or disappears completely is effective, and the therapeutic effect of medicine of the present invention to B group patient is as shown in table 3.
Table 3 pharmaceutical composition of the present invention is to the therapeutic outcome of B group patient
(3) pharmaceutical composition of the present invention is to the therapeutic outcome of C group patient
C group patient is equally divided into six groups (a ~ f groups), often organizes 50 people.Give pharmaceutical composition prepared by six groups of oral embodiment of the present invention 1 ~ 4 of patient and comparative example 1 ~ 2 respectively, every day is early, middle and late respectively to be taken 2 (sheets) after meal, and serve on 5 days, accumulated dose of taking medicine is 0.73g raw medicinal herbs/kg every day.
Efficacy evaluation: symptom is invalid without alleviation or DeGrain; Symptom substantially disappears or disappears completely is effective, and the therapeutic effect of medicine of the present invention to C group patient is as shown in table 4.
Table 4 pharmaceutical composition of the present invention is to the therapeutic outcome of C group patient
In experimentation, before and after patient medication, all do not find untoward reaction, also that is to say that pharmaceutical composition of the present invention has no side effect to patient body.
According to the data in table 2 ~ 4, the dyspeptic pharmaceutical composition for the treatment of of the present invention effectively can treat A, B, C tri-kinds of symptoms, and effective percentage reaches about 90%.The effective percentage of pharmaceutical composition described in embodiment 1 ~ 4 is compared with the effective percentage of pharmaceutical composition described in comparative example 1 ~ 2, all improve more than 20%, show that pharmaceutical composition of the present invention needs the mutual compatibility of each raw material components, play the effect of Synergistic, just can reach best therapeutic effect, lack the curative effect that any Herba indigoferae Pseudotinctoriae all significantly can reduce pharmaceutical composition.
From the data of embodiment in table 2 ~ 41 ~ 4, the curative effect of pharmaceutical composition described in embodiment 1 is compared with the curative effect of pharmaceutical composition described in embodiment 2 ~ 4, all more than 5 ~ 10% are improve to the effective percentage for the treatment of indigestion symptom, showing that the pharmaceutical composition described in embodiment 1 achieves non-obvious therapeutic effect, is optimum implementation of the present invention.

Claims (5)

1. treat a dyspeptic pharmaceutical composition, it is characterized in that, it is the medicament be made up of following raw material: Radix Ginseng, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae, Fructus Phyllanthi, Folium Nelumbinis and Radix Glycyrrhizae.
2. pharmaceutical composition according to claim 1, is characterized in that, the weight of described each raw material is: Radix Ginseng 1 ~ 20 part, Endothelium Corneum Gigeriae Galli 2 ~ 18 parts, Pericarpium Citri Reticulatae 1 ~ 22 part, Fructus Phyllanthi 1 ~ 15 part, 2 ~ 10 parts, Folium Nelumbinis and 1 ~ 8 part, Radix Glycyrrhizae.
3. pharmaceutical composition according to claim 2, is characterized in that, the weight of described each raw material is: Radix Ginseng 1 ~ 15 part, Endothelium Corneum Gigeriae Galli 2 ~ 15 parts, Pericarpium Citri Reticulatae 1 ~ 18 part, Fructus Phyllanthi 2 ~ 12 parts, 3 ~ 10 parts, Folium Nelumbinis and 1 ~ 5 part, Radix Glycyrrhizae.
4. pharmaceutical composition according to claim 3, is characterized in that, the weight of described each raw material is: Radix Ginseng 1 ~ 10 part, Endothelium Corneum Gigeriae Galli 4 ~ 10 parts, Pericarpium Citri Reticulatae 5 ~ 12 parts, Fructus Phyllanthi 3 ~ 7 parts, 3 ~ 6 parts, Folium Nelumbinis and 2 ~ 3 parts, Radix Glycyrrhizae.
5. pharmaceutical composition according to claim 4, is characterized in that, the weight of described each raw material is: Radix Ginseng 5 parts, Endothelium Corneum Gigeriae Galli 6 parts, Pericarpium Citri Reticulatae 6 parts, Fructus Phyllanthi 6 parts, 6 parts, Folium Nelumbinis and 3 parts, Radix Glycyrrhizae.
CN201410619642.XA 2014-11-06 2014-11-06 Pharmaceutical composition for treating indigestion Pending CN104435247A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109663009A (en) * 2019-01-21 2019-04-23 广西中医药大学 A kind of strong drug composition and preparation method thereof for treating functional dyspepsia FD
CN112023018A (en) * 2020-10-23 2020-12-04 广西壮族自治区兽医研究所 Traditional Chinese medicine composition for preventing and treating livestock diarrhea and preparation method and application thereof

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CN102940673A (en) * 2012-10-31 2013-02-27 成都医路康医学技术服务有限公司 Medicine composition for treating dyspepsia

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109663009A (en) * 2019-01-21 2019-04-23 广西中医药大学 A kind of strong drug composition and preparation method thereof for treating functional dyspepsia FD
CN112023018A (en) * 2020-10-23 2020-12-04 广西壮族自治区兽医研究所 Traditional Chinese medicine composition for preventing and treating livestock diarrhea and preparation method and application thereof
CN112023018B (en) * 2020-10-23 2022-04-05 广西壮族自治区兽医研究所 Traditional Chinese medicine composition for preventing and treating livestock diarrhea and preparation method and application thereof

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