CN105412753A - Stone removing capsule and preparation method thereof - Google Patents
Stone removing capsule and preparation method thereof Download PDFInfo
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- CN105412753A CN105412753A CN201510864858.7A CN201510864858A CN105412753A CN 105412753 A CN105412753 A CN 105412753A CN 201510864858 A CN201510864858 A CN 201510864858A CN 105412753 A CN105412753 A CN 105412753A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/12—Magnesium silicate
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
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- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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- A61K36/18—Magnoliophyta (angiosperms)
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Abstract
The invention discloses a stone removing capsule and a preparation method thereof. The capsule is characterized in that 88 g of rhizoma nardostachyos, 26.5 g of resurrection lily rhizome, 250 g of herba desmodii styracifolii, 56 g of astragalus, 56 g of poria cocos, 56 g of polygonum aviculare, 56 g of lygodium japonicum, 56 g of epimedium, 60 g of selfheal, 60 g of talc, 56 g of corydalis tubers, 50 g of radix angelica sinensis, 50 g of morinda officinalis, 44 g of semen plantaginis, 45 g of peach kernels and 55 g of endothelium corneum gigeriae galli 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 stone removing capsule is prepared. The disintegration time is remarkably shortened, the treatment effect is obviously better than that of stone removing capsules 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 clean stone curing capsule and preparation method thereof.
Background technology
The kidney invigorating of clean stone curing capsule, diuresis, calculus.The hydronephrosis, urinary tract infection etc. that are used for the treatment of renal calculus, ureteral calculus, vesical calculus and are caused by calculus.Commercially available clean stone curing capsule 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 clean stone curing capsule that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Radix Et Rhizoma Nardostachyos 88g, Rhizoma Kaempferiae 26.5g, Herba Desmodii Styracifolii 250g, Radix Astragali 56g, Poria 56g , Herba Polygoni Avicularis 56g, Spora Lygodii 56g, Herba Epimedii 56g, Spica Prunellae 60g, Talcum 60g, Rhizoma Corydalis 56g, Radix Angelicae Sinensis 50g, Radix Morindae Officinalis 50g, Semen Plantaginis 44g, Semen Persicae 45g, Endothelium Corneum Gigeriae Galli 55g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 17 ~ 35Mpa, extraction temperature 23 ~ 40 DEG C, separator pressure 13 ~ 18Mpa, separator temperature 42 ~ 54 DEG C, disengaging time 1.7 ~ 3.6 hours, carbon dioxide flow 28 ~ 33L per hour, obtains extracting solution; Get extracting solution 64 ~ 77 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 clean stone curing capsule 1500.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Radix Et Rhizoma Nardostachyos: China's coastal port one ministerial standard.RADIXETRHIZOMANARDOSTACHYOS this product is the dry root and rhizome of Valerianaceae plant Radix Et Rhizoma Nardostachyos NardostachyschinensisBatal. or spoon Ye Gansong NardostachysjatamansiDC..Spring, Qiu Erji excavate, and removing silt and impurity, dry or dry in the shade.
Rhizoma Kaempferiae: Chinese Pharmacopoeia version one ministerial standard in 2010.This product has another name called that three a kind of apples, mountain are peppery, Sha Jiang.For the rhizome of zingiberaceous plant Rhizoma Kaempferiae KaempferiagalangaL..Originate in Taiwan, Guangdong, Guangxi, Yunnan.Winter excavates, and cleans, and removing fibrous root, section, dries.
Herba Desmodii Styracifolii: China's coastal port one ministerial standard.This product is leguminous plant Herba Desmodii Styracifolii Desmodiumstyracifolium(Osb.) dry aerial parts of Merr..Summer, Qiu Erji tap, and removing impurity dries.
The Radix Astragali: China's coastal port one ministerial standard.This product is leguminous plant Radix Astagali Astragalusmembranaceus(Fisch.) Bge.var.mongholicus(Bge.) Hsiao or Radix Astragali Astragalusmembranaceus(Fisch.) Bge, dry root.Spring, autumn two, Lee excavated, and removing fibrous root and root head, 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 ".
Herba Polygoni Avicularis: China's coastal port one ministerial standard.This product is the dry aerial parts of Liao section Zhi Wu Herba Polygoni Avicularis PolygonumaviculareL..Gather during leafiness in summer, removing root and impurity, dry.
Spora Lygodii: China's coastal port one ministerial standard.This product is Lygodiaceae plant Spora Lygodii Lygodiumjaponicum(Thunb.) the drying and ripening spore of Sw..Tap rattan leaf when autumn, spore did not come off, dry, crumple or lay spore, removing rattan leaf.
Herba Epimedii: China's coastal port one ministerial standard.This product is Berberidaceae plant Herba Epimedii EpimediumbrevicornumMaxim., Epimedium sagittatum Epimediumsagittatum(Sieb.etZucc.) dry aerial parts of Maxim., E. Pubescens EpimediumpubescensMaxim., Wushan excessive sheep work EpimediumwushanenseT.S.Ying or Herba Epimedii EpimediumkoreanumNabai.Tap when summer, autumn, stem and leaf was luxuriant, the thick stalk of removing and impurity, dry or dry in the shade.
Spica Prunellae: China's coastal port one ministerial standard.This product is the dry fruit ear of labiate Spica Prunellae PrunellavulgarisL..Gather when summer, fruit ear was brownish red, removing impurity, dries.
Talcum: China's coastal port one ministerial standard.This product is silicates mineral talc race Talcum. main containing hydrous magnesium silicate (Mg3(Si4O10) (OH) 2) excavate after, removing silt and assorted stone.
Rhizoma Corydalis: China's coastal port one ministerial standard.This product is the dry tuber of papaveraceae plant corydalis CorydalisyanhusnoW.T.Wang.Excavate when early summer stem and leaf is withered, removing fibrous root, cleans, and puts in boiling water and boils to during just without the white heart, take out, dry.
Radix Angelicae Sinensis: China's coastal port one ministerial standard.This product is umbelliferae angelica Angelicasinensis(Oliv.) dry root of Diels.Autumn end excavates, and removing fibrous root and silt, after moisture slightly evaporates, be bundled into wisp, upper canopy, with pyrotechnics slowly smoke-dried beancurd.
Radix Morindae Officinalis: China's coastal port one ministerial standard.This product is the dry root of Maguireothamnus speciosus Radix Morindae Officinalis MorindaofficinalisHow.The whole year all can excavate, and cleans, and removing fibrous root, shines to 6 seventy percent dry, beat flat gently, dry.
Semen Plantaginis: China's coastal port one ministerial standard.This product is the dry mature seed of Plantaginaceae plant Herba Plantaginis PlantagoasiaticaL. or Plantago depressa Willd PlantagodepressaWilld..To gather when summer, autumn two season seed maturity fruit ear, dry, rub seed, removing impurity.
Semen Persicae: China's coastal port one ministerial standard.This product is rosaceous plant Fructus Persicae Prunuspersica(L.) Batsch or Prunus davidiana Prunusdavidiana(Cars.) dry mature seed of Franch..Gather after fruit maturation, removing sarcocarp and nucleocapsid, take out seed, dry.
Endothelium Corneum Gigeriae Galli: China's coastal port one ministerial standard.This product is the dry inner wall of sandbag of Phasianidae animal man chicken GallusgallusdomesticusBrisson.After killing chicken, take out chicken and doze, peel inwall immediately. clean. 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.
Clean raw material used by stone curing capsule all can be bought from pharmaceuticals and obtain above, 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 Radix Et Rhizoma Nardostachyos 88g, Rhizoma Kaempferiae 26.5g, Herba Desmodii Styracifolii 250g, Radix Astragali 56g, Poria 56g , Herba Polygoni Avicularis 56g, Spora Lygodii 56g, Herba Epimedii 56g, Spica Prunellae 60g, Talcum 60g, Rhizoma Corydalis 56g, Radix Angelicae Sinensis 50g, Radix Morindae Officinalis 50g, Semen Plantaginis 44g, Semen Persicae 45g, Endothelium Corneum Gigeriae Galli 55g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 17Mpa, extraction temperature 23 DEG C, separator pressure 13Mpa, separator temperature 42 DEG C, disengaging time 1.7 hours, carbon dioxide flow 28L 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 clean stone curing capsule 1500.
Specific embodiments of the invention 2
Get Radix Et Rhizoma Nardostachyos 88g, Rhizoma Kaempferiae 26.5g, Herba Desmodii Styracifolii 250g, Radix Astragali 56g, Poria 56g , Herba Polygoni Avicularis 56g, Spora Lygodii 56g, Herba Epimedii 56g, Spica Prunellae 60g, Talcum 60g, Rhizoma Corydalis 56g, Radix Angelicae Sinensis 50g, Radix Morindae Officinalis 50g, Semen Plantaginis 44g, Semen Persicae 45g, Endothelium Corneum Gigeriae Galli 55g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 35Mpa, extraction temperature 40 DEG C, separator pressure 18Mpa, separator temperature 54 DEG C, disengaging time 3.6 hours, carbon dioxide flow 33L per hour, obtains extracting solution; Get extracting solution 77 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 clean stone curing capsule 1500.
Specific embodiments of the invention 3
Get Radix Et Rhizoma Nardostachyos 88g, Rhizoma Kaempferiae 26.5g, Herba Desmodii Styracifolii 250g, Radix Astragali 56g, Poria 56g , Herba Polygoni Avicularis 56g, Spora Lygodii 56g, Herba Epimedii 56g, Spica Prunellae 60g, Talcum 60g, Rhizoma Corydalis 56g, Radix Angelicae Sinensis 50g, Radix Morindae Officinalis 50g, Semen Plantaginis 44g, Semen Persicae 45g, Endothelium Corneum Gigeriae Galli 55g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 26Mpa, extraction temperature 32 DEG C, separator pressure 15Mpa, separator temperature 48 DEG C, disengaging time 2.7 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 clean stone curing capsule 1500.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make clean stone curing capsule.Actual effect of the present invention is investigated below with the clean stone curing capsule that embodiment 3 is obtained:
(1) the clean stone curing capsule of embodiment 3 and contrast disintegration of commercially available clean stone curing capsule
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
The clean stone curing capsule of table 1 embodiment 3 and commercially available clean stone curing capsule contrast table disintegration
The above results shows, clean stone curing capsule prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available clean stone curing capsule.
(2) the clean stone curing capsule of embodiment 3 and commercially available clean stone curing capsule treatment renal calculus, ureteral calculus, vesical calculus and the hydronephrosis caused by calculus, urinary tract infection clinical observation on the therapeutic effect
1 case scenario
Statistics outpatient service and inpatient, observes renal calculus, ureteral calculus, vesical calculus and the hydronephrosis caused by calculus, urinary tract infection case 133 example, 45 years old mean age altogether.Patient is divided into two groups, test group takes the clean stone curing capsule of embodiment 3, and matched group takes commercially available clean stone curing capsule.
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
The clean stone curing capsule of table 2 embodiment 3 and commercially available clean stone curing capsule clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, clean stone curing capsule prepared by the present invention is when treating renal calculus, ureteral calculus, vesical calculus and the hydronephrosis caused by calculus, urinary tract infection, evident in efficacy higher than commercially available clean stone curing capsule, p < 0.05.
Claims (3)
1. a treatment renal calculus, ureteral calculus, vesical calculus and the hydronephrosis caused by calculus, the Chinese medicine of urinary tract infection, it is characterized in that getting Radix Et Rhizoma Nardostachyos 88g, Rhizoma Kaempferiae 26.5g, Herba Desmodii Styracifolii 250g, Radix Astragali 56g, Poria 56g, Herba Polygoni Avicularis 56g, Spora Lygodii 56g, Herba Epimedii 56g, Spica Prunellae 60g, Talcum 60g, Rhizoma Corydalis 56g, Radix Angelicae Sinensis 50g, Radix Morindae Officinalis 50g, Semen Plantaginis 44g, Semen Persicae 45g, Endothelium Corneum Gigeriae Galli 55g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 17 ~ 35Mpa, extraction temperature 23 ~ 40 DEG C, separator pressure 13 ~ 18Mpa, separator temperature 42 ~ 54 DEG C, disengaging time 1.7 ~ 3.6 hours, carbon dioxide flow 28 ~ 33L per hour, obtain extracting solution, get extracting solution 64 ~ 77 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 clean stone curing capsule.
2. the preparation method of Chinese medicine according to claim 1, it is characterized in that getting Radix Et Rhizoma Nardostachyos 88g, Rhizoma Kaempferiae 26.5g, Herba Desmodii Styracifolii 250g, Radix Astragali 56g, Poria 56g, Herba Polygoni Avicularis 56g, Spora Lygodii 56g, Herba Epimedii 56g, Spica Prunellae 60g, Talcum 60g, Rhizoma Corydalis 56g, Radix Angelicae Sinensis 50g, Radix Morindae Officinalis 50g, Semen Plantaginis 44g, Semen Persicae 45g, Endothelium Corneum Gigeriae Galli 55g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 17 ~ 35Mpa, extraction temperature 23 ~ 40 DEG C, separator pressure 13 ~ 18Mpa, separator temperature 42 ~ 54 DEG C, disengaging time 1.7 ~ 3.6 hours, carbon dioxide flow 28 ~ 33L per hour, obtain extracting solution, get extracting solution 64 ~ 77 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 clean stone curing capsule.
3. the preparation method of Chinese medicine according to claim 1, get Radix Et Rhizoma Nardostachyos 88g, Rhizoma Kaempferiae 26.5g, Herba Desmodii Styracifolii 250g, Radix Astragali 56g, Poria 56g, Herba Polygoni Avicularis 56g, Spora Lygodii 56g, Herba Epimedii 56g, Spica Prunellae 60g, Talcum 60g, Rhizoma Corydalis 56g, Radix Angelicae Sinensis 50g, Radix Morindae Officinalis 50g, Semen Plantaginis 44g, Semen Persicae 45g, Endothelium Corneum Gigeriae Galli 55g, 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 15Mpa, separator temperature 48 DEG C, disengaging time 2.7 hours, carbon dioxide flow 30L per hour, obtain 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 clean stone curing capsule.
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