CN105560809A - Production process of preparation containing radix ophiopogonis, processed schisandra chinensis and prepared rehmannia root - Google Patents

Production process of preparation containing radix ophiopogonis, processed schisandra chinensis and prepared rehmannia root Download PDF

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Publication number
CN105560809A
CN105560809A CN201511007837.XA CN201511007837A CN105560809A CN 105560809 A CN105560809 A CN 105560809A CN 201511007837 A CN201511007837 A CN 201511007837A CN 105560809 A CN105560809 A CN 105560809A
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filtrate
fructus schisandrae
schisandrae chinensis
powder
extractum
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龙凤荣
王瑶
李珂
孙敏
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GUIZHOU HONGKANG PHARMACEUTICAL CO Ltd
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GUIZHOU HONGKANG PHARMACEUTICAL CO Ltd
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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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968Ophiopogon (Lilyturf)
    • AHUMAN NECESSITIES
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/076Poria
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    • A61K36/185Magnoliopsida (dicotyledons)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/57Magnoliaceae (Magnolia family)
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    • 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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/79Schisandraceae (Schisandra family)
    • AHUMAN NECESSITIES
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    • 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)
    • A61K36/80Scrophulariaceae (Figwort family)
    • A61K36/804Rehmannia
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    • 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/884Alismataceae (Water-plantain 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/894Dioscoreaceae (Yam family)
    • A61K36/8945Dioscorea, e.g. yam, Chinese yam or water yam
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    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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    • 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
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    • A61K9/2068Compounds of unknown constitution, e.g. material from plants or animals
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    • 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
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    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
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    • 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

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Abstract

The invention discloses a production process of a preparation containing radix ophiopogonis, processed schisandra chinensis and prepared rehmannia root. The preparation consists of radix ophiopogonis, processed schisandra chinensis, prepared rehmannia root, processed semen corni, bark of tree peony root, Chinese yam, Poria cocos and rhizoma alismatis. Based on the properties of the medicines in the prescription of the preparation containing radix ophiopogonis, processed schisandra chinensis and prepared rehmannia root and the roles of the medicines in the prescription, the specific production process is improved, so that the active ingredient schisandrin of schisandra chinensis can be easily detected, and the content of the detected schisandrin is high. Therefore, the preparation is refined, substantial in drug effect and good in clinic curative effect.

Description

A kind of processing technology of Maiwei-dihuang preparation
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of processing technology of Maiwei-dihuang preparation.
Background technology
Chinese medicine extraction is a kind of method conventional in herbal pharmaceutical, and chemical composition of Chinese materia medica is extremely complicated, need extract the effective active ingredient of Chinese herbs of human body from the mixture of complexity.To improve drug effect.
Maiwei-dihuang is made primarily of Radix Ophiopogonis, Fructus Schisandrae (processed), Radix Rehmanniae Preparata, Fructus Corni (processed), Cortex Moutan, Rhizoma Dioscoreae, Poria and Rhizoma Alismatis.There is the effect that lung is supported in nourishing kidney.For deficiency of YIN of both the lung and kidney, hectic fever night sweat, dry pharynx hemoptysis, vertigo and tinnitus, soreness of the waist and knees, the disease such as to quench one's thirst.
In prior art, Maiwei-dihuang makes like this: Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan are ground into fine powder; All the other medicines decoct with water three times, each 1h, for the first time 10 times of water gagings, second and third time adds 8 times of water gagings, collecting decoction, filters, it is 1.10-1.15 (80 DEG C) thick paste that filtrate is condensed into relative density, adds above-mentioned fine powder, mixing, dry (60 DEG C), pulverize, add 0.5% magnesium stearate, mixing, incapsulate, to obtain final product.But inventor finds in research process, adopt existing extraction process to make in Maiwei-dihuang, the effective ingredient schisandrin of Fructus Schisandrae Chinensis is not easily measured.Make the clinical efficacy of Maiwei-dihuang desirable not enough.
Summary of the invention
The invention provides a kind of processing technology of Maiwei-dihuang preparation.The present invention is according to the character of medicine each in Maiwei-dihuang preparation prescription, and this medicine role in prescription, the concrete processing technology of Maiwei-dihuang preparation and parameter are improved, the effective ingredient schisandrin of Fructus Schisandrae Chinensis is easily measured, and the schisandrin content measured is high.Make the refine more of this medicine, drug effect is more remarkable, and clinical efficacy is good.
To achieve these goals, the invention provides following technical scheme: a kind of processing technology of Maiwei-dihuang preparation, described Maiwei-dihuang preparation calculates by weight, primarily of Radix Ophiopogonis 50-70 part, Fructus Schisandrae (processed) 30-50 part, Radix Rehmanniae Preparata 150-170 part, Fructus Corni (processed) 70-90 part, Cortex Moutan 50-70 part, Rhizoma Dioscoreae 70-90 part, Poria 50-70 part and Rhizoma Alismatis 50-70 part makes; The processing technology of described Maiwei-dihuang preparation is: get Fructus Schisandrae Chinensis, cleans, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, then after moistening to vinegar liquid is exhausted by schisandra chinensis medicinal material completely, heating, when frying slightly dry to yellow color, takes out after cooling, dry at 30-40 DEG C, be ground into coarse granule, obtain final product, period, every 10-15 hour turned over medicine once; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction that concentration is 75-85%, extracting solution merges, and filter, filtrate recycling ethanol is also concentrated into extractum, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding concentration is 75-85% alcoholic solution reflux, extract, and filtrate merges, and filter, in filtrate, add citric acid solution until filtrate pH value is 5-6, filtrate recycling ethanol is also concentrated into extractum, obtains Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis adds water, collecting decoction, filter, filtrate is condensed into thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, and mixing, dry at 60 DEG C, pulverize, add adjuvant, mixing, makes pharmaceutical preparation.
In the processing technology of aforesaid Maiwei-dihuang preparation, described Maiwei-dihuang preparation calculates by weight, makes primarily of Radix Ophiopogonis 60 parts, Fructus Schisandrae (processed) 40 parts, Radix Rehmanniae Preparata 160 parts, Fructus Corni (processed) 80 parts, Cortex Moutan 60 parts, Rhizoma Dioscoreae 80 parts, 60 parts, Poria and Rhizoma Alismatis 60 parts.
In the processing technology of aforesaid Maiwei-dihuang preparation, the processing technology of described Maiwei-dihuang preparation is: get Fructus Schisandrae Chinensis, clean, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then within moistening 30-40 minute, being exhausted by schisandra chinensis medicinal material completely to vinegar liquid, heating, when frying slightly dry to yellow color, take out after cooling, dry 80-90 hour at 30-40 DEG C, be ground into coarse granule, obtain, period, every 10-15 hour turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 30-40:1-5; Get above-mentioned Fructus Schisandrae Chinensis granule, add ethanol extraction 2-3 time that 8-10 times amount concentration is 75-85%, each 1-2 hour, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 6-8 times amount concentration is 75-85% alcoholic solution reflux, extract, 3-5 time, each 1-2h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.05-0.15mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add adjuvant, mixing, makes pharmaceutical preparation.
In the processing technology of aforesaid Maiwei-dihuang preparation, the processing technology of described Maiwei-dihuang preparation is: get Fructus Schisandrae Chinensis, clean, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add adjuvant, mixing, makes pharmaceutical preparation.
In the processing technology of aforesaid Maiwei-dihuang preparation, described pharmaceutical preparation is oral formulations.
In the processing technology of aforesaid Maiwei-dihuang preparation, described oral formulations is capsule, tablet, granule or pill.
In the processing technology of aforesaid Maiwei-dihuang preparation, described capsule is prepared like this: get Fructus Schisandrae Chinensis, cleans, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, and heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add magnesium stearate, mixing, incapsulates, to obtain final product.
In the processing technology of aforesaid Maiwei-dihuang preparation, described tablet is prepared like this: get Fructus Schisandrae Chinensis, cleans, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, and heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add starch and the dextrine powder of the amount of making 10-20%, mixing, with alcohol granulation, drying, tabletting, to obtain final product.
In the processing technology of aforesaid Maiwei-dihuang preparation, described granule is prepared like this: get Fructus Schisandrae Chinensis, cleans, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, and heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add starch and the dextrine powder of the amount of making 10-20%, mixing, with alcohol granulation, drying, to obtain final product.
In the processing technology of aforesaid Maiwei-dihuang preparation, described pill is prepared like this: get Fructus Schisandrae Chinensis, cleans, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, and heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add the refined honey of the amount of making 10-20% and appropriate water, general ball, to obtain final product.
The present invention adopts Radix Ophiopogonis, Fructus Schisandrae (processed), Radix Rehmanniae Preparata, Fructus Corni (processed), Cortex Moutan, Rhizoma Dioscoreae, Poria and Rhizoma Alismatis to make medicine, i.e. Maiwei-dihuang preparation, and each raw material has good synergism, and the preparation made has the effect that lung is supported in nourishing kidney.For deficiency of YIN of both the lung and kidney, hectic fever night sweat, dry pharynx hemoptysis, vertigo and tinnitus, soreness of the waist and knees, the disease such as to quench one's thirst.
The process for making of existing production Maiwei-dihuang preparation is: Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan are ground into fine powder; All the other medicines decoct with water three times, each 1h, for the first time 10 times of water gagings, second and third time adds 8 times of water gagings, collecting decoction, filters, it is 1.10-1.15 (80 DEG C) thick paste that filtrate is condensed into relative density, adds above-mentioned fine powder, mixing, dry (60 DEG C), pulverize, add 0.5% magnesium stearate, mixing, incapsulate, to obtain final product.But inventor finds in research process, adopt and make in Maiwei-dihuang in this way, the effective ingredient of Radix Rehmanniae Preparata is not easily measured.Make the clinical efficacy of Maiwei-dihuang desirable not enough.Inventor also finds in technical study, adopt the inventive method to concoct Fructus Schisandrae Chinensis, and the Fructus Schisandrae Chinensis after the process of preparing Chinese medicine and Fructus Corni are extracted separately, in the Maiwei-dihuang preparation made like this, the effective ingredient of Fructus Schisandrae Chinensis is easily measured, and the effective ingredient of the Fructus Schisandrae Chinensis measured is high.This just makes the refine more of this medicine, and drug effect is more remarkable, and clinical efficacy is good.Therefore this technique facilitates the dissolution rate of the dissolution rate of effective ingredient in Fructus Schisandrae Chinensis, particularly schisandrin, after the dissolution rate raising of schisandrin, effectively can improve the drug effect of Maiwei-dihuang preparation.
Compared with prior art, in the Maiwei-dihuang preparation that the method for the invention makes, the effective ingredient schisandrin in Fructus Schisandrae Chinensis is easily measured, and the schisandrin content measured is high.Effectively can improve the drug effect of Maiwei-dihuang preparation.
Invention has been a large amount of experimentatioies, is below the result of experimentation of the present invention:
Experimental example 1: schisandrin Content inspect
1 raw material
1.1 Maiwei-dihuangs of the present invention, make by the method for embodiment 1.
1.2 existing Maiwei-dihuangs: make by following technique:
Prescription: Radix Ophiopogonis 60g, Fructus Schisandrae (processed) 40g, Radix Rehmanniae Preparata 160g, Fructus Corni (processed) 80g, Cortex Moutan 60g, Rhizoma Dioscoreae 80g, Poria 60g, Rhizoma Alismatis 60g and adjuvant.
Technique: Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan are ground into fine powder; All the other medicines decoct with water three times, each 1h, for the first time 10 times of water gagings, second and third time adds 8 times of water gagings, collecting decoction, filters, it is 1.10-1.15 (80 DEG C) thick paste that filtrate is condensed into relative density, adds above-mentioned fine powder, mixing, dry (60 DEG C), pulverize, add 0.5% magnesium stearate, mixing, incapsulates, makes 1000,0.35g/ grain, to obtain final product.
1.3 Shimadzu LC-10AT high performance liquid chromatographs; Zhejiang University's intelligence reaches NEC2000 chromatographic work station; BS-201-S electronic balance; EL204 electronic balance; KQ-100DB type numerical control ultrasonic cleaner. methanol is chromatographically pure, and water is redistilled water, and schisandrin reference substance, Nat'l Pharmaceutical & Biological Products Control Institute provides.
2 experimental techniques and result
2.1 chromatographic condition
VP-ODS chromatographic column (150mm × 4.6mm, 5um); Mobile phase is methanol one water (13:7); Determined wavelength 250nm; Flow velocity 1mL/min, column temperature room temperature; Sample size 10uL.
The preparation of 2.2 reference substance solution
Get schisandrin reference substance 7.5mg, put in 25mL measuring bottle, be diluted to scale with dissolve with methanol, shake up, obtain (every 1mL is containing schisandrin 0.3mg), obtain reference substance solution.
The preparation of 2.3 need testing solutions
The preparation of need testing solution 1: get Maiwei-dihuang 100g of the present invention, porphyrize, precision takes, get 0.25g, put, put in 20mI volumetric flask, add methanol 18mL, supersound process (power 250W, frequency 20Hz) 20min, takes out, add methanol to scale, shake up, get subsequent filtrate, as need testing solution 1.
The preparation of need testing solution 2: enchashment has Maiwei-dihuang 100g, porphyrize, and precision takes, get 0.25g, put, put in 20mI volumetric flask, add methanol 18mL, supersound process (power 250W, frequency 20Hz) 20min, takes out, add methanol to scale, shake up, get subsequent filtrate, as namely obtaining need testing solution 2.
Mass concentration is that the schisandrin reference substance solution of 0.3mg/mL dilutes respectively by 2.4 standard curves preparations is 0.03,0.06,0.12,0.3,0.6, the solution of 1.2,3.0mg/mL, respectively gets 10uL injection liquid chromatography. with reference substance mass concentration (C, ug/mL) be abscissa, peak area (A) is vertical coordinate, makes linear regression, obtains regression equation Y=2 × 10 6x+30294 (R 2=0.9995, n=7), schisandrin is good in 0.03 ~ 3.0mg/mL scope internal linear.
2.5 precision test
Get same mass concentration schisandrin reference substance solution, continuous sample introduction 5 times, each sample introduction 10ul, measure schisandrin integrating peak areas value, be respectively 5288184.5,5248670.5,5297594.0,5452531.5 and 5310764.5, obtaining schisandrin peak RSD is 1.47%.Show that this law precision is good.
2.6 stability test
Get schisandrin reference substance solution, respectively 0,2,4,6,8,12h sample introduction 10uL, record chromatogram, schisandrin peak area is respectively 5454004.05248670.5,5297594.0,5452331.5, and 5310764.5, obtaining schisandrin peak RSD is 1.47%.Therefore this law has good stability.
2.7 repeated experiment
Get Maiwei-dihuang preparation of the present invention and existing Maiwei-dihuang preparation respectively, prepare test liquid 1 and each 5 parts of need testing solution 2 by the preparation method of need testing solution, respectively sample introduction.Calculating RSD is 1.755% and 1.853%, shows that this method repeatability is good.
2.8 average recovery tests
Precision takes 6 parts, the Maiwei-dihuang sample of the present invention of known content, put in 100ml volumetric flask, it is appropriate that precision adds schisandrin reference substance solution, press text chromatographic condition to measure, calculate the response rate, result shows, meansigma methods is the response rate 101.02% and 99.78%, RSD=0.5% and RSD=0.55%.
2.9 sample sizes measure
Measure Maiwei-dihuang of the present invention and existing Maiwei-dihuang 1.7g respectively, accurately weighed, by need testing solution 1 and the preparation of need testing solution 2 preparation method, parallelly measure 6 parts, draw 20 microlitres respectively by chromatographic condition, sample introduction analysis, by the content calculating schisandrin, the results are shown in Table 1.
The assay result of table 1 schisandrin
As known from Table 1, in Maiwei-dihuang of the present invention, the average content of schisandrin is 0.45mg/g, and in existing Maiwei-dihuang, the average content of schisandrin is 0.37mg/g.
Conclusion: compared with existing Maiwei-dihuang, in Maiwei-dihuang of the present invention, the content of the effective ingredient schisandrin of Radix Rehmanniae Preparata is higher.In like manner, the preparation of other dosage forms made according to extracting method of the present invention, the active constituent content of Radix Rehmanniae Preparata also should increase.
Experimental example 2: Effect tests
1 experiment material
1.1 medicine
1.1.1 Maiwei-dihuang preparation of the present invention, with embodiment 1..
1.1.2 existing Maiwei-dihuang preparation, with experimental example 1.
1.2 laboratory animal Kunming kind rat (Wistar) are primary animal, purchased from Guangdong Medical Lab Animal Center.150-180g, Mus 6-8 in age week, male and female half and half, the certification of fitness: probatio inspectionem pecuoarem word 26-99A029; This institute Ordinary Animal Lab environmental facility quality certification: No. 99C032, Guangdong searching.
1.3 instruments and reagent OLYMPUS automatic clinical chemistry analyzer, Japanese OLYMPUS Products; Austria products C liniBio-128C microplate reader; Low speed centrifuge LD4-2, Beijing Medical Centrifugal Machine Factory's product.
1.3.2 reagent serum blood urea nitrogen (BUN), creatinine (Cr), triacylglycerol (TG), cholesterol (TC), albumin (A) and total protein (TP) measure test kit, Beijing Zhong Sheng biological engineering high and new technology company product; 20000603) and malonaldehyde (MDA) content (lot number: 20000522) mensuration test kit, Bioengineering Research Institute's product is built up in Nanjing the active (lot number: of superoxide dismutase (SOD).
2 experimental techniques
2.1 models preparations and experiment grouping get SD rat, 150 1 180g, 6 one 8 weeks ages of Mus, male and female half and half, 7 rats are randomly drawed as blank group, all the other Rat Method, respectively ipADM3mg/kg by sex, body weight, every day 3 times, modeling for three days on end, 14d after modeling, albustix detects urine protein situation, all urine protein)+one ++ rat, namely ADM-NS model formed.After modeling the 15th day, be divided into 3 groups at random by ABW on the same day: Maiwei-dihuang Capsules group of the present invention, existing Maiwei-dihuang Capsules group and model control group, respectively ig administration, every day 1 time, totally 15 days.Blank and model group then replace with isometric distilled water.29th day fasting 18h, all animals eye socket blood-letting in the 30th day, separation of serum, saves backup in-40 DEG C of refrigerators.
2.2 Biochemical Indexes, by institute's separation of serum, respectively by the operational approach of each Testing index description, measure BUN.Cr, TC, TG, A, TP and MDA content and SOD activity.
2.3 histological observations are put to death, dissect animal, take out kidney, and after claiming weight in wet base, by 10% formaldehyde and antiseptic, fix, HE dyes, and Microscopic observation renal pathology changes.In addition, score to often organizing rat kidney tissue, and be averaged pathology integration and (observe 10 glomerule in specimen, by item pathological change light and heavy degree scorings such as mesangial matrix * and sclerosis, interstitial inflammation infiltration and vascular lesions, often kind of pathological changes divides 0-3 level, note 0-3 divides, and scores accumulated are the pathology average integral of this specimen).
2.4 statistical analysis adopt new drug statistical procedure (NDST) software (establishment of mathematics pharmacology Professional Committee of Chinese Pharmacological Society one), measurement data, and with t inspection between group, (heterogeneity of variance is t 0, inspection); Ranked data rank test, carries out data statistics.Experimental data is used represent.
2 experimental results
2.1 on the impact of sick Ren Mus function, blood fat and plasma protein in table 2 and table 3.
Table 2 is on the impact of ADM nephrotic syndrome rat BUN, Cr, TC, TG
Note: compare with ADM-NS model control group, * P<0.05, * * P<0.01;
Compare with existing Maiwei-dihuang group, +p<0.05.
Table 3 is on the impact of ADM nephrotic syndrome rat A and TP
Note: compare with ADM-NS model control group, * P<0.05, * * P<0.01;
Compare with existing Maiwei-dihuang group, +p<0.05.
As seen from table, model control group compares with blank group, and ADM causes nephrotic syndrome rat BUV; Cr, TC, TG content increases, and A, TP content reduces, and difference all has highly significant (P<0.01); And each medicine all obviously can reduce the high BUN of disease Mus, Cr, TC, TG content, improves the A that it is low, the content of TP, difference all has significance (P<0.01), shows that each medicine all can improve every biochemical indicator pathological change of disease Mus to some extent.And Maiwei-dihuang group of the present invention is better than existing Maiwei-dihuang group.
2.2 on the impact of sick Mus SOD and MDA in table 4.
Table 4 is on the impact of sick Mus SOD and MDA
Note: compare with ADM-NS model control group, * P<0.05, * * P<0.01;
Compare with existing Maiwei-dihuang group, +p<0.05.
2.3 on the impact that sick Ren Mus exponential sum renal pathology changes, in table 5 and table 6.
The impact that table 5 changes sick Ren Mus exponential sum renal pathology
Note: compare with ADM-NS model control group, * P<0.05, * * P<0.01;
Compare with existing Maiwei-dihuang group, +p<0.05.
The impact that table 6 changes sick Ren Mus exponential sum renal pathology
Note: compare with ADM-NS model control group, * P<0.05, * * P<0.01;
Compare with existing Maiwei-dihuang group, +p<0.05.
Model control group compares with blank group, sick Ren Mus organizes average pathology integration and the obvious pathological change of Xiang Juncheng such as mesangial matrix * and sclerosis, interstitial inflammation infiltration and vascular lesion, the histopathological indications of every observation, difference all has highly significant (P<0.01.); Maiwei-dihuang group of the present invention and existing Maiwei-dihuang group all obviously can improve the pathological change of disease Ren Mus tissue, and difference has highly significant (P<0.01), and effect is mainly manifested in the pathological change improving mesangial matrix * and sclerosis; And Maiwei-dihuang group effect of the present invention is better than existing Maiwei-dihuang group.
Conclusion, Maiwei-dihuang preparation of the present invention and existing Maiwei-dihuang preparation all have therapeutical effect to nephrotic syndrome, and Maiwei-dihuang preparation of the present invention is better than existing Maiwei-dihuang preparation.
Detailed description of the invention:
Embodiment 1:
Formula: Radix Ophiopogonis 60g, Fructus Schisandrae (processed) 40g, Radix Rehmanniae Preparata 160g, Fructus Corni (processed) 80g, Cortex Moutan 60g, Rhizoma Dioscoreae 80g, Poria 60g, Rhizoma Alismatis 60g and adjuvant.
Technique: get Fructus Schisandrae Chinensis, cleans, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, then, after moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, heating, when frying slightly dry to yellow color, after taking-up cools 6h, at 34-40 DEG C, drying 85 hours, is ground into coarse granule, obtains final product, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add magnesium stearate, mixing, incapsulates, make 1000, obtain capsule.
Usage and dosage: oral, a 3-4 grain, 3 times on the one.
Specification: 0.35g/ grain.
Storage: sealing.
Embodiment 2:
Radix Ophiopogonis 60g, Fructus Schisandrae (processed) 40g, Radix Rehmanniae Preparata 160g, Fructus Corni (processed) 80g, Cortex Moutan 60g, Rhizoma Dioscoreae 80g, Poria 60g, Rhizoma Alismatis 60g and adjuvant.
Technique: get Fructus Schisandrae Chinensis, cleans, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, then, after moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, heating, when frying slightly dry to yellow color, after taking-up cools 6h, at 34-40 DEG C, drying 85 hours, is ground into coarse granule, obtains final product, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add starch and the dextrine powder of the amount of making 10-20%, mixing, with alcohol granulation, drying, tabletting, obtains tablet.
Usage and dosage: oral, a 3-4 sheet, 3 times on the one.
Specification: 0.35g/ sheet.
Storage: sealing.
Embodiment 3:
Radix Ophiopogonis 60g, Fructus Schisandrae (processed) 40g, Radix Rehmanniae Preparata 160g, Fructus Corni (processed) 80g, Cortex Moutan 60g, Rhizoma Dioscoreae 80g, Poria 60g, Rhizoma Alismatis 60g and adjuvant.
Technique: get Fructus Schisandrae Chinensis, cleans, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, then, after moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, heating, when frying slightly dry to yellow color, after taking-up cools 6h, at 34-40 DEG C, drying 85 hours, is ground into coarse granule, obtains final product, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add starch and the dextrine powder of the amount of making 10-20%, mixing, with alcohol granulation, drying, obtains granule.
Usage and dosage: oral, a 5-10g, 3 times on the one.
Specification 5g/ bag.
Storage: sealing.

Claims (10)

1. the processing technology of a Maiwei-dihuang preparation, it is characterized in that: described Maiwei-dihuang preparation calculates by weight, primarily of Radix Ophiopogonis 50-70 part, Fructus Schisandrae (processed) 30-50 part, Radix Rehmanniae Preparata 150-170 part, Fructus Corni (processed) 70-90 part, Cortex Moutan 50-70 part, Rhizoma Dioscoreae 70-90 part, Poria 50-70 part and Rhizoma Alismatis 50-70 part makes; The processing technology of described Maiwei-dihuang preparation is: get Fructus Schisandrae Chinensis, cleans, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, then after moistening to vinegar liquid is exhausted by schisandra chinensis medicinal material completely, heating, when frying slightly dry to yellow color, takes out after cooling, dry at 30-40 DEG C, be ground into coarse granule, obtain final product, period, every 10-15 hour turned over medicine once; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction that concentration is 75-85%, extracting solution merges, and filter, filtrate recycling ethanol is also concentrated into extractum, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding concentration is 75-85% alcoholic solution reflux, extract, and filtrate merges, and filter, in filtrate, add citric acid solution until filtrate pH value is 5-6, filtrate recycling ethanol is also concentrated into extractum, obtains Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis adds water, collecting decoction, filter, filtrate is condensed into thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, and mixing, dry at 60 DEG C, pulverize, add adjuvant, mixing, makes pharmaceutical preparation.
2. the processing technology of Maiwei-dihuang preparation as claimed in claim 1, it is characterized in that: described Maiwei-dihuang preparation calculates by weight, make primarily of Radix Ophiopogonis 60 parts, Fructus Schisandrae (processed) 40 parts, Radix Rehmanniae Preparata 160 parts, Fructus Corni (processed) 80 parts, Cortex Moutan 60 parts, Rhizoma Dioscoreae 80 parts, 60 parts, Poria and Rhizoma Alismatis 60 parts.
3. the processing technology of Maiwei-dihuang preparation as claimed in claim 1, it is characterized in that: the processing technology of described Maiwei-dihuang preparation is: get Fructus Schisandrae Chinensis, clean, after drying, be placed in demulcen container, vinegar is sprayed by the method for spray, sprinkling limit, limit is stirred until evenly, then after within moistening 30-40 minute, being exhausted by schisandra chinensis medicinal material completely to vinegar liquid, heating, when frying slightly dry to yellow color, after taking-up cools, dry 80-90 hour at 30-40 DEG C, be ground into coarse granule, obtain, period, every 10-15 hour turned over medicine once, the weight ratio of Fructus Schisandrae Chinensis and vinegar is 30-40:1-5, get above-mentioned Fructus Schisandrae Chinensis granule, add ethanol extraction 2-3 time that 8-10 times amount concentration is 75-85%, each 1-2 hour, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder, get Fructus Corni, adding 6-8 times amount concentration is 75-85% alcoholic solution reflux, extract, 3-5 time, each 1-2h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.05-0.15mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum, get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add adjuvant, mixing, makes pharmaceutical preparation.
4. the processing technology of Maiwei-dihuang preparation as claimed in claim 3, it is characterized in that: the processing technology of described Maiwei-dihuang preparation is: get Fructus Schisandrae Chinensis, clean, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add adjuvant, mixing, makes pharmaceutical preparation.
5. the processing technology of the Maiwei-dihuang preparation as described in claim 1,3 or 4, is characterized in that: described pharmaceutical preparation is oral formulations.
6. the processing technology of Maiwei-dihuang preparation as claimed in claim 5, is characterized in that: described oral formulations is capsule, tablet, granule or pill.
7. the processing technology of Maiwei-dihuang preparation as claimed in claim 6, it is characterized in that: described capsule is prepared like this: get Fructus Schisandrae Chinensis, clean, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add magnesium stearate, mixing, incapsulates, to obtain final product.
8. the processing technology of Maiwei-dihuang preparation as claimed in claim 6, it is characterized in that: described tablet is prepared like this: get Fructus Schisandrae Chinensis, clean, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add starch and the dextrine powder of the amount of making 10-20%, mixing, with alcohol granulation, drying, tabletting, to obtain final product.
9. the processing technology of Maiwei-dihuang preparation as claimed in claim 6, it is characterized in that: described granule is prepared like this: get Fructus Schisandrae Chinensis, clean, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add starch and the dextrine powder of the amount of making 10-20%, mixing, with alcohol granulation, drying, to obtain final product.
10. the processing technology of Maiwei-dihuang preparation as claimed in claim 6, it is characterized in that: described pill is prepared like this: get Fructus Schisandrae Chinensis, clean, after drying, be placed in demulcen container, spray vinegar by the method for spray, sprinkling limit, limit is stirred until evenly, after then moistening is exhausted by schisandra chinensis medicinal material to vinegar liquid for 35 minutes completely, heating, when stir-fry is slightly dry to yellow color, take out after cooling 6h, drying 85 hours at 34-40 DEG C, be ground into coarse granule, obtain, every 12 hours of period turned over medicine once, and the weight ratio of Fructus Schisandrae Chinensis and vinegar is 35:3; Get above-mentioned Fructus Schisandrae Chinensis granule, add the ethanol extraction 2 times that 9 times amount concentration are 80%, each 1.5 hours, extracting solution merge, filter, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, extract dry, pulverizes, obtains Fructus Schisandrae Chinensis dried cream powder; Get Fructus Corni, adding 7 times amount concentration is 80% alcoholic solution reflux, extract, 4 times, each 1.5h, filtrate merges, filter, in filtrate, add the citric acid solution of 0.1mol/L until filtrate pH value is 5-6, filtrate recycling ethanol and when being concentrated into 50-60 DEG C relative density be the extractum of 1.10-1.20, obtain Fructus Corni extractum; Get Radix Ophiopogonis, Rhizoma Dioscoreae, Poria, Cortex Moutan be ground into fine powder, get Radix Rehmanniae Preparata and Rhizoma Alismatis decocts with water three times, each 1h, first time adds 10 times of water gagings, and second and third time adds 8 times of water gagings, collecting decoction, filter, when filtrate is condensed into 80 DEG C, relative density is 1.10-1.15 thick paste, with above-mentioned mixed-powder, Radix Rehmanniae Preparata powder and Indian Bread, mixing, dry, pulverize at 60 DEG C, add the refined honey of the amount of making 10-20% and appropriate water, general ball, to obtain final product.
CN201511007837.XA 2015-12-29 2015-12-29 Production process of preparation containing radix ophiopogonis, processed schisandra chinensis and prepared rehmannia root Withdrawn CN105560809A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106109836A (en) * 2016-08-28 2016-11-16 刘传水 A kind of Chinese medicine treating Diabetic Acute complication ketoacidosis and preparation method thereof
CN112439025A (en) * 2020-12-16 2021-03-05 江西和明制药有限公司 Preparation method of Maiwei rehmannia oral liquid

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101700349A (en) * 2008-11-24 2010-05-05 四川旭阳药业有限责任公司 Liquid hard capsule of Anagex extract and preparation method thereof
CN102225152A (en) * 2011-06-23 2011-10-26 贵州弘康药业有限公司 Preparation method of Maiwei rehmannia oral preparation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101700349A (en) * 2008-11-24 2010-05-05 四川旭阳药业有限责任公司 Liquid hard capsule of Anagex extract and preparation method thereof
CN102225152A (en) * 2011-06-23 2011-10-26 贵州弘康药业有限公司 Preparation method of Maiwei rehmannia oral preparation

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106109836A (en) * 2016-08-28 2016-11-16 刘传水 A kind of Chinese medicine treating Diabetic Acute complication ketoacidosis and preparation method thereof
CN112439025A (en) * 2020-12-16 2021-03-05 江西和明制药有限公司 Preparation method of Maiwei rehmannia oral liquid

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Application publication date: 20160511