CN105412694A - Anti-hunger and thirst-quenching tablet and preparation method thereof - Google Patents
Anti-hunger and thirst-quenching tablet and preparation method thereof Download PDFInfo
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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)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/57—Magnoliaceae (Magnolia family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/756—Phellodendron, e.g. corktree
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/79—Schisandraceae (Schisandra family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8968—Ophiopogon (Lilyturf)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8969—Polygonatum (Solomon's seal)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K36/8994—Coix (Job's tears)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention discloses an anti-hunger and thirst-quenching tablet and a preparation method thereof. The tablet is characterized in that 100g of tribulus terrestris, 50 g of coix seeds, 100 g of cortex phellodendri, 50 g of radix rehmanniae, 100 g of wolfberry fruits, 100 g of polygonatum odoratum, 100 g of radix ophiopogonis and fructus schizandrae are taken, extraction is carried out through a carbon dioxide supercritical extraction method, pressure reduction and drying are conducted, the materials are smashed into nano dry paste through a high-energy nano impacting mill, functional auxiliary materials are added, and the anti-hunger and thirst-quenching tablet is prepared. The disintegration time is remarkably shortened, the treatment effect is remarkably better than that of anti-hunger and thirst-quenching tablets sold in the market, and positive effects are obtained.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of anti-hydatic agent and preparation method thereof.
Background technology
Anti-hydatic agent Replenishing QI and nourishing YIN, moisturizes and promotes the production of body fluid, and quenches the thirst in anti-Tianjin.For non-insulin-dependent diabetes mellitus, to chronic atrophic gastritis, deficiency of stomach-YIN person also has certain effect.Commercially available anti-hydatic agent 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 anti-hydatic agent that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Fructus Tribuli 100g, Semen Coicis 50g, Cortex Phellodendri 100g, Radix Rehmanniae 50g, Fructus Lycii 100g, Rhizoma Polygonati Odorati 100g, Radix Ophiopogonis 100g, Fructus Schisandrae Chinensis, 60g is ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add L MALIC ACID 80 ~ 120g, 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 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional polyethylene glycol 6000 7 ~ 9g, granulate, be pressed into 1000, obtained anti-hydatic agent.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Fructus Tribuli: China's coastal port one ministerial standard.This product is the dry mature fruit of zygophyllaceae plant Fructus Tribuli TribulusterrestrisL..Tap plant during fruit maturation in autumn, dry, lay fruit, removing impurity.
Semen Coicis: China's coastal port one ministerial standard.This product is grass Semen Coicis Coixlacryma-jobiL.var.ma-yuen(ROman.) dry mature kernal of Stapf.Tap plant during fruit maturation in autumn, dry, lay fruit, then dry, except decapsidate, yellowish-brown seed coat and impurity, collect kernel.
Cortex Phellodendri: China's coastal port one ministerial standard.This product is the dry bark of rutaceae wampee PhellodendronchinenseSchneid..Practise and claim " Cortex Phellodendri ".After stripping bark, removing rough bark, dries.
Radix Rehmanniae: China's coastal port one ministerial standard.This product is the fresh of scrophulariaceae rehmannia glutinosa plant RehmanniaglutinosaLibosch. or dried root.Autumn excavates, except removing LU, fibrous root and silt, and using fresh herb; Or Radix Rehmanniae is slowly cured to about most probably dry.The former practises title " Radix Rehmanniae ", and the latter practises title " Radix Rehmanniae ".
Fructus Lycii: China's coastal port one ministerial standard.This product is the dry mature fruit of plant of Solanaceae lycium barbarum LyciumbarbarumL..Summer, autumn two gather when season, fruit took on a red color, hot-air seasoning, removing carpopodium, or dry in the air to rhicnosis, dry, removing carpopodium.
Rhizoma Polygonati Odorati: China's coastal port one ministerial standard.This product is liliaceous plant Rhizoma Polygonati Odorati Polygonatumodoratum(Mill.) dry rhizome of Druce.Autumn excavates, removing fibrous root, clean, shine to softness, repeatedly rub, dry in the sun to without hard-core, dry; Or steam thoroughly, rub to translucent, dry.
Radix Ophiopogonis: China's coastal port one ministerial standard.This product is liliaceous plant Ophiopogonjaponicus(Thunb. Radix Ophiopogonis) dried root of Ker-Gawl..Summer excavates, and cleans, is repeatedly exposed to the sun, banks up. and to very likely in, removing fibrous root, dry.
Fructus Schisandrae Chinensis: China's coastal port one ministerial standard.This product is magnoliaceae schisandra Schisandrachfnensis(Turcz.) dry mature fruit of Baill., practise and claim " Radix Schisandrae Bicoloris ".Pluck during fruit maturation in autumn, dry or dry after steaming, removing carpopodium and impurity.
L MALIC ACID: 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.
Hypromellose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Micropowder silica gel: Chinese Pharmacopoeia version two ministerial standard in 2010.
Polyethylene glycol 6000: Chinese Pharmacopoeia version two ministerial standard in 2010.
Raw material used by above anti-hydatic agent 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 Fructus Tribuli 100g, Semen Coicis 50g, Cortex Phellodendri 100g, Radix Rehmanniae 50g, Fructus Lycii 100g, Rhizoma Polygonati Odorati 100g, Radix Ophiopogonis 100g, Fructus Schisandrae Chinensis, is ground into 60 order coarse powder, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 20Mpa, extraction temperature 20 DEG C, separator pressure 15Mpa, separator temperature 40 DEG C, disengaging time 2 hours, carbon dioxide flow 20L per hour, obtains extracting solution; Get extracting solution 60 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add L MALIC ACID 80g, 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 35g, crospolyvinylpyrrolidone 35g, cross-linking sodium carboxymethyl cellulose 35g, hypromellose 25g, micropowder silica gel 15g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional polyethylene glycol 6000 7g, granulate, be pressed into 1000, obtained anti-hydatic agent.
Specific embodiments of the invention 2
Get Fructus Tribuli 100g, Semen Coicis 50g, Cortex Phellodendri 100g, Radix Rehmanniae 50g, Fructus Lycii 100g, Rhizoma Polygonati Odorati 100g, Radix Ophiopogonis 100g, Fructus Schisandrae Chinensis, is ground into 60 order coarse powder, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 40Mpa, extraction temperature 40 DEG C, separator pressure 25Mpa, separator temperature 60 DEG C, disengaging time 4 hours, carbon dioxide flow 40L per hour, obtains extracting solution; Get extracting solution 80 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add L MALIC ACID 120g, 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 45g, hypromellose 35g, micropowder silica gel 25g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional polyethylene glycol 6000 9g, granulate, be pressed into 1000, obtained anti-hydatic agent.
Specific embodiments of the invention 3
Get Fructus Tribuli 100g, Semen Coicis 50g, Cortex Phellodendri 100g, Radix Rehmanniae 50g, Fructus Lycii 100g, Rhizoma Polygonati Odorati 100g, Radix Ophiopogonis 100g, Fructus Schisandrae Chinensis, is ground into 60 order coarse powder, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 30 DEG C, separator pressure 20Mpa, 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 L MALIC ACID 100g, 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 40g, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, micropowder silica gel 20g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional polyethylene glycol 6000 8g, granulate, be pressed into 1000, obtained anti-hydatic agent.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make anti-hydatic agent.Actual effect of the present invention is investigated below with the anti-hydatic agent that embodiment 3 is obtained:
(1) embodiment 3 anti-hydatic agent and commercially available anti-hydatic agent contrast disintegration
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 anti-hydatic agent and commercially available anti-hydatic agent contrast table disintegration
The above results shows, anti-hydatic agent prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available anti-hydatic agent.
(2) embodiment 3 anti-hydatic agent and commercially available anti-hydatic agent treat non-insulin-dependent diabetes mellitus clinical observation on the therapeutic effect
1 case scenario
Statistics outpatient service and inpatient, observe non-insulin-dependent diabetes mellitus case 100 example, 60 years old mean age altogether.Patient is divided into two groups, test group takes embodiment 3 anti-hydatic agent, and matched group takes commercially available anti-hydatic agent.
2 efficacy assessment standards
According to new Chinese medicine 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 anti-hydatic agent and commercially available anti-hydatic agent clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, anti-hydatic agent prepared by the present invention is evident in efficacy higher than commercially available anti-hydatic agent when treating non-insulin-dependent diabetes mellitus, p < 0.05.
Claims (3)
1. treat an anti-hydatic agent for non-insulin-dependent diabetes mellitus, it is characterized in that getting Fructus Tribuli 100g, Semen Coicis 50g, Cortex Phellodendri 100g, Radix Rehmanniae 50g, Fructus Lycii 100g, Rhizoma Polygonati Odorati 100g, Radix Ophiopogonis 100g, Fructus Schisandrae Chinensis, 60g is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add L MALIC ACID 80 ~ 120g, 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 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional polyethylene glycol 6000 7 ~ 9g, granulate, suppresses to obtain anti-hydatic agent.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Fructus Tribuli 100g, Semen Coicis 50g, Cortex Phellodendri 100g, Radix Rehmanniae 50g, Fructus Lycii 100g, Rhizoma Polygonati Odorati 100g, Radix Ophiopogonis 100g, Fructus Schisandrae Chinensis, 60g is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add L MALIC ACID 80 ~ 120g, 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 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional polyethylene glycol 6000 7 ~ 9g, granulate, suppresses to obtain anti-hydatic agent.
3. the preparation method of Chinese medicine according to claim 1, gets Fructus Tribuli 100g, Semen Coicis 50g, Cortex Phellodendri 100g, Radix Rehmanniae 50g, Fructus Lycii 100g, Rhizoma Polygonati Odorati 100g, Radix Ophiopogonis 100g, Fructus Schisandrae Chinensis, is ground into 60 order coarse powder, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 30 DEG C, separator pressure 20Mpa, 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 L MALIC ACID 100g, 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 40g, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, micropowder silica gel 20g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional polyethylene glycol 6000 8g, granulate, suppresses to obtain anti-hydatic agent.
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