CN105343429A - Capsule containing Chinese wolfberry, chrysanthemum and rehmannia - Google Patents
Capsule containing Chinese wolfberry, chrysanthemum and rehmannia Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/40—Cornaceae (Dogwood family)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
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- A—HUMAN NECESSITIES
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
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- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention discloses a capsule containing Chinese wolfberry, chrysanthemum and rehmannia, as well as a preparation method of the capsule. The preparation method is characterized by comprising the following steps: taking 37.5 g of acorns tatarinowii root, 112.5 g of euphorbia lathyris seed, 55 g of poria cocos, 45 g of paeonia suffruticosa bark, 80 g of dioscorea opposita root, 160 g of prepared rehmannia root and 50 g of cornus officinalis fruit for extraction according to a carbon dioxide supercritical extraction method, conducting vacuum drying, conducting pulverization to form a nanometer dry extract by a high-energy nanometer impacting grinder, and adding functional auxiliary materials to prepare the capsule. The disintegration time is remarkably shortened, and the capsule provided by the invention has a remarkably better curative effect than the commercially available capsule containing Chinese wolfberry, chrysanthemum and rehmannia, and achieves active effects.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Qiju Dihuang capsules and preparation method thereof.
Background technology
Qiju Dihuang capsules nourishing the kidney and liver.For hepatic and renal YIN deficiency, vertigo and tinnitus, photophobia photophobia, epiphora induced by wind, blurring of vision.Commercially available Qiju Dihuang capsules is due to prescription and technological reason, and curative effect is not satisfactory, and preparation adopts traditional handicraft preparation, there is the deficiencies such as prolonged disintegration, curative effect are low.
Summary of the invention
The present invention, for overcoming above-mentioned deficiency, provides Qiju Dihuang capsules that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Rhizoma Acori Graminei 37.5, Semen Euphorbiae 112.5g, Poria 55g, Cortex Moutan 45g, Rhizoma Dioscoreae 80g, Radix Rehmanniae Preparata 160g, Fructus Corni 50g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 15 ~ 37Mpa, extraction temperature 23 ~ 40 DEG C, separator pressure 13 ~ 19Mpa, separator temperature 44 ~ 57 DEG C, disengaging time 1.9 ~ 4.0 hours, carbon dioxide flow 27 ~ 32L per hour, obtains extracting solution; Get extracting solution 64 ~ 76 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained Qiju Dihuang capsules 800.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Rhizoma Acori Graminei: China's coastal port one ministerial standard.This product is the dry rhizome of acorus gramineus araceae plant AcornstatarinowiiSchott.Autumn, each two seasons excavate, and removing must be reported and silt, dries.
Semen Euphorbiae: China's coastal port one ministerial standard.This product is the dry mature seed of euphorbia plant Euphorbia lathyris EuphorbialathyrisL..Gather when summer, autumn two season fruit maturation, removing impurity, dry.
Poria: China's coastal port one ministerial standard.This product is On Polyporaceae Poria Poriacocos(Schw.) dry sclerotia of Wolf.Excavate more than the 7-9 month, dig out rear removing silt, bank up after " diaphoresis ", spread out and dry in the air to dry tack free, then " diaphoresis ", after extremely now scatter and disappear in wrinkle, the large portion of internal moisture for several times repeatedly, dry in the shade, be called " Poria "; Or fresh Poria is pressed different parts cutting, cloudy in, be called " Cortex Sclerotii Poriae " and " Poria block ".
Cortex Moutan: China's coastal port one ministerial standard.This product is the dry root bark of ranunculaceae peony PaeoniasuffruticosaAndr..Autumn excavates root, and removing radicula and silt, strip root bark, dry.
Rhizoma Dioscoreae: China's coastal port one ministerial standard.This product is the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae DioscoreaoppositaThunb..Winter, stem and leaf was excavated after withering, and cut macroradical head, cleaned, and removing crust and fibrous root are dry; Also have and select loose straight dry Rhizoma Dioscoreae, put in clear water, be dipped into without the dry heart, vexed, trim two ends, be twisted into plank cylindric, dry, polishing, practise and claim " light yam ".
Radix Rehmanniae Preparata: China's coastal port one ministerial standard.This product is the Preparation process product of Radix Rehmanniae.
Fructus Corni: China's coastal port one ministerial standard.This product is the drying and ripening sarcocarp of Fructus Corni English section plant Fructus Corni CornusofficinalisSieb.etZucc..Picking fruit when time of the year when autumn changes into winter, peel reddened, after drying with slow fire or putting in boiling water and slightly scald, in time except removal core, dry.
Mannitol: Chinese Pharmacopoeia version two ministerial standard in 2010.
Microcrystalline Cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Crospolyvinylpyrrolidone: Chinese Pharmacopoeia version two ministerial standard in 2010.
Cross-linking sodium carboxymethyl cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Carboxymethyl starch sodium: Chinese Pharmacopoeia version two ministerial standard in 2010.
Magnesium stearate: Chinese Pharmacopoeia version two ministerial standard in 2010.
Raw material used by above Qiju Dihuang capsules all can be bought from pharmaceuticals and obtain, and all can be used to implement the present invention program as long as meet national standard.
In foregoing invention scheme, term used is pharmacy proprietary term, as " decompression " etc. all defers to Chinese Pharmacopoeia regulation and pharmaceutical practice of being correlated with.
Unit g in the present invention also can be other weight portion, does not affect the enforcement of the present invention program.
Equipment Market described in the present invention program all has sale, is not limited to typical production producer, as long as technical specification can reach requirement, all can be used to realize the present invention.
Four detailed description of the invention
Specific embodiments of the invention 1
Get Rhizoma Acori Graminei 37.5, Semen Euphorbiae 112.5g, Poria 55g, Cortex Moutan 45g, Rhizoma Dioscoreae 80g, Radix Rehmanniae Preparata 160g, Fructus Corni 50g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 15Mpa, extraction temperature 23 DEG C, separator pressure 13Mpa, separator temperature 44 DEG C, disengaging time 1.9 hours, carbon dioxide flow 27L per hour, obtains extracting solution; Get extracting solution 64 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 150g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45g, crospolyvinylpyrrolidone 45g, cross-linking sodium carboxymethyl cellulose 35g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional carboxymethyl starch sodium 7g, magnesium stearate 1g, granulate, incapsulates, obtained Qiju Dihuang capsules 800.
Specific embodiments of the invention 2
Get Rhizoma Acori Graminei 37.5, Semen Euphorbiae 112.5g, Poria 55g, Cortex Moutan 45g, Rhizoma Dioscoreae 80g, Radix Rehmanniae Preparata 160g, Fructus Corni 50g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 37Mpa, extraction temperature 40 DEG C, separator pressure 19Mpa, separator temperature 57 DEG C, disengaging time 4.0 hours, carbon dioxide flow 32L per hour, obtains extracting solution; Get extracting solution 76 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 55g, crospolyvinylpyrrolidone 55g, cross-linking sodium carboxymethyl cellulose 45g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional carboxymethyl starch sodium 9g, magnesium stearate 3g, granulate, incapsulates, obtained Qiju Dihuang capsules 800.
Specific embodiments of the invention 3
Get Rhizoma Acori Graminei 37.5, Semen Euphorbiae 112.5g, Poria 55g, Cortex Moutan 45g, Rhizoma Dioscoreae 80g, Radix Rehmanniae Preparata 160g, Fructus Corni 50g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 26Mpa, extraction temperature 32 DEG C, separator pressure 16Mpa, separator temperature 50 DEG C, disengaging time 3 hours, carbon dioxide flow 30L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 175g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 50g, crospolyvinylpyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 40g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, granulate, incapsulates, obtained Qiju Dihuang capsules 800.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make Qiju Dihuang capsules.Actual effect of the present invention is investigated below with the Qiju Dihuang capsules that embodiment 3 is obtained:
(1) embodiment 3 Qiju Dihuang capsules and contrast disintegration of commercially available Qiju Dihuang capsules
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 Qiju Dihuang capsules and commercially available Qiju Dihuang capsules contrast table disintegration
The above results shows, Qiju Dihuang capsules prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available Qiju Dihuang capsules.
(2) embodiment 3 Qiju Dihuang capsules and commercially available Qiju Dihuang capsules treatment hepatic and renal YIN deficiency, vertigo and tinnitus, photophobia photophobia, epiphora induced by wind, blurring of vision clinical observation on the therapeutic effect
1 case scenario
Statistics outpatient service and inpatient, observe hepatic and renal YIN deficiency, vertigo and tinnitus, photophobia photophobia, epiphora induced by wind, blurring of vision altogether.Case 137 example, 64 years old mean age.Patient is divided into two groups, test group takes embodiment 3 Qiju Dihuang capsules, and matched group takes commercially available Qiju Dihuang capsules.
2 efficacy assessment standards
According to new Chinese medicine treatment guideline of clinical investigations tcm syndrome curative effect determinate standard:
Clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.
Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%.
Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%.
Invalid: tcm clinical practice symptom, sign are all not improved or increase the weight of, syndrome integral reduces < 30%.
Computing formula: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
3 clinical observation result
Table 2 embodiment 3 Qiju Dihuang capsules and commercially available Qiju Dihuang capsules clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, Qiju Dihuang capsules prepared by the present invention is treating hepatic and renal YIN deficiency, vertigo and tinnitus, photophobia photophobia, epiphora induced by wind, during blurring of vision, evident in efficacy higher than commercially available Qiju Dihuang capsules, p < 0.05.
Claims (3)
1. treat a hepatic and renal YIN deficiency, vertigo and tinnitus, photophobia photophobia, epiphora induced by wind, the Chinese medicine of blurring of vision, is characterized in that getting Rhizoma Acori Graminei 37.5, Semen Euphorbiae 112.5g, Poria 55g, Cortex Moutan 45g, Rhizoma Dioscoreae 80g, Radix Rehmanniae Preparata 160g, Fructus Corni 50g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 15 ~ 37Mpa, extraction temperature 23 ~ 40 DEG C, separator pressure 13 ~ 19Mpa, separator temperature 44 ~ 57 DEG C, disengaging time 1.9 ~ 4.0 hours, carbon dioxide flow 27 ~ 32L per hour, obtains extracting solution; Get extracting solution 64 ~ 76 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained Qiju Dihuang capsules.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Rhizoma Acori Graminei 37.5, Semen Euphorbiae 112.5g, Poria 55g, Cortex Moutan 45g, Rhizoma Dioscoreae 80g, Radix Rehmanniae Preparata 160g, Fructus Corni 50g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 15 ~ 37Mpa, extraction temperature 23 ~ 40 DEG C, separator pressure 13 ~ 19Mpa, separator temperature 44 ~ 57 DEG C, disengaging time 1.9 ~ 4.0 hours, carbon dioxide flow 27 ~ 32L per hour, obtains extracting solution; Get extracting solution 64 ~ 76 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained Qiju Dihuang capsules.
3. the preparation method of Chinese medicine according to claim 1, gets Rhizoma Acori Graminei 37.5, Semen Euphorbiae 112.5g, Poria 55g, Cortex Moutan 45g, Rhizoma Dioscoreae 80g, Radix Rehmanniae Preparata 160g, Fructus Corni 50g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 26Mpa, extraction temperature 32 DEG C, separator pressure 16Mpa, separator temperature 50 DEG C, disengaging time 3 hours, carbon dioxide flow 30L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 175g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 50g, crospolyvinylpyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 40g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, granulate, incapsulates, obtained Qiju Dihuang capsules.
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