CN105343677A - Embolism eliminating and collateral dredging capsules and preparing method thereof - Google Patents

Embolism eliminating and collateral dredging capsules and preparing method thereof Download PDF

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Publication number
CN105343677A
CN105343677A CN201510905092.2A CN201510905092A CN105343677A CN 105343677 A CN105343677 A CN 105343677A CN 201510905092 A CN201510905092 A CN 201510905092A CN 105343677 A CN105343677 A CN 105343677A
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carbon dioxide
dry
ground
jiaonang
extract
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不公告发明人
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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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)
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236—Ligusticum (licorice-root)
    • A—HUMAN NECESSITIES
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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)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
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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)
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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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/67—Piperaceae (Pepper family), e.g. Jamaican pepper or kava
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/884—Alismataceae (Water-plantain family)
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Abstract

The invention discloses embolism eliminating and collateral dredging capsules and a preparing method thereof. The preparing method is characterized in that 15.6 g of pogostemon cablin, 78 g of pericarpium granati, 104 g of semen coicis, 156 g of fructus piperis longi, 287 g of ligusticum wallichii, 215 g of salvia miltiorrhiza, 412 g of radix astragali, 128 g of rhizoma alismatis, 144 g of pseudo-ginseng, 78 g of sophora japonica and 156 g of cassia twig are taken and extracted through a carbon dioxide supercritical extraction method, the extract is dried under reduced pressure and smashed into nanometer dry paste through high-energy nanometer impact grinding, and a functional auxiliary material is added to prepare the embolism eliminating and collateral dredging capsules. The disintegration time is remarkably shortened, the treatment effect is remarkably better than commercially available embolism eliminating and collateral dredging capsules, and a positive effect is achieved.

Description

A kind of XIAOSHUAN TONGLUO JIAONANG and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of XIAOSHUAN TONGLUO JIAONANG and preparation method thereof.
Background technology
XIAOSHUAN TONGLUO JIAONANG blood circulation promoting and blood stasis dispelling, promoting the flow of QI in the collateral by warming the meridian.For the apoplexy caused by obstruction of collaterals by blood stasis, disease sees dull expression, speech stuttering puckery, hands and feet coolness, limbs pain; Cerebral infarction and hyperlipemia are shown in above-mentioned patient.Commercially available XIAOSHUAN TONGLUO JIAONANG 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 XIAOSHUAN TONGLUO JIAONANG that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Herba Pogostemonis 15.6g, Pericarpium Granati 78g, Semen Coicis 104g, Fructus Piperis Longi 156g, Rhizoma Chuanxiong 287g, Radix Salviae Miltiorrhizae 215g, Radix Astragali 412g, Rhizoma Alismatis 128g, Radix Notoginseng 144g, Flos Sophorae 78g, Ramulus Cinnamomi 156g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 19 ~ 44Mpa, extraction temperature 24 ~ 37 DEG C, separator pressure 11 ~ 20Mpa, separator temperature 41 ~ 51 DEG C, disengaging time 2.6 ~ 3.9 hours, carbon dioxide flow 21 ~ 32L per hour, obtains extracting solution; Get extracting solution 62 ~ 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 XIAOSHUAN TONGLUO JIAONANG 1100.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Herba Pogostemonis: China's coastal port one ministerial standard.This product is that labiate extensively stores fragrant Pogostemoncablin(Blanco) dry aerial parts of Benth..Tap when branch and leaf are luxuriant, Exposure to Sunlight is vexed for night, repeatedly to dry.
Pericarpium Granati: China's coastal port one ministerial standard.This product is the dry peel of Punicaceae plant Punica granatum L. PunicagranatumL..Autumn collects peel after fruit maturation, dries.
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.
Fructus Piperis Longi: Chinese Pharmacopoeia version one ministerial standard in 2010.This product is the nearly ripe or mature fruit cluster of the drying of Piperaceae plant Fructus Piperis Longi PiperlongumL..Fruit ear is gathered by during green blackening, and removing impurity, dries.
Rhizoma Chuanxiong: China's coastal port one ministerial standard.This product is the dry rhizome of samphire Rhizoma Chuanxiong LigusticumchuanriongHort..The joint dish that summer works as on stem is significantly outstanding, and excavates during purplish, and removing silt, shines post-drying, then remove fibrous root.
Radix Salviae Miltiorrhizae: China's coastal port one ministerial standard.This product is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae SalviamiltiorrhizaBge..Spring, Qiu Erji excavate, removing silt, dry.
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.
Rhizoma Alismatis: China's coastal port one ministerial standard.This product is Notes On Alism At Aceae Rhizoma Alismatis Alismaorientalis(Sam.) dry tuber of Juzep..Excavate when winter, stem and leaf started withered, cleaning, drying, removing fibrous root and rough bark.
Radix Notoginseng: China's coastal port one ministerial standard.This product is the dry root and rhizome of panax araliaceae plant Punaxnotoginseng (Burk.) F.H.Chen.Autumn excavates before the flowers are in blossom, cleans, and separately main root, a root and rhizome, dry.Supporting root is practised and is claimed " rib ", and rhizome is practised and claimed " clip ".
Flos Sophorae: China's coastal port one ministerial standard.This product is the dry flower and alabastrum of leguminous plant Chinese scholartree SophorajaponicaL..Summer, the flowers are in blossom put or alabastrum is formed time gather, dry in time, except debranching, stalk and impurity.The former practises title " Flos Sophorae ", and the latter practises title " Flos Sophorae Immaturus ".
Ramulus Cinnamomi: China's coastal port one ministerial standard.This product is the dry twig of canella Cortex Cinnamomi CinnamomumcassiaPresl.Spring, Xia Erji gather, and except defoliation, dry, or section is dried.
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 XIAOSHUAN TONGLUO JIAONANG 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 Herba Pogostemonis 15.6g, Pericarpium Granati 78g, Semen Coicis 104g, Fructus Piperis Longi 156g, Rhizoma Chuanxiong 287g, Radix Salviae Miltiorrhizae 215g, Radix Astragali 412g, Rhizoma Alismatis 128g, Radix Notoginseng 144g, Flos Sophorae 78g, Ramulus Cinnamomi 156g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 19Mpa, extraction temperature 24 DEG C, separator pressure 11Mpa, separator temperature 41 DEG C, disengaging time 2.6 hours, carbon dioxide flow 21L per hour, obtains extracting solution; Get extracting solution 62 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 XIAOSHUAN TONGLUO JIAONANG 1100.
Specific embodiments of the invention 2
Get Herba Pogostemonis 15.6g, Pericarpium Granati 78g, Semen Coicis 104g, Fructus Piperis Longi 156g, Rhizoma Chuanxiong 287g, Radix Salviae Miltiorrhizae 215g, Radix Astragali 412g, Rhizoma Alismatis 128g, Radix Notoginseng 144g, Flos Sophorae 78g, Ramulus Cinnamomi 156g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 19 ~ 44Mpa, extraction temperature 37 DEG C, separator pressure 20Mpa, separator temperature 51 DEG C, disengaging time 3.9 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 XIAOSHUAN TONGLUO JIAONANG 1100.
Specific embodiments of the invention 3
Get Herba Pogostemonis 15.6g, Pericarpium Granati 78g, Semen Coicis 104g, Fructus Piperis Longi 156g, Rhizoma Chuanxiong 287g, Radix Salviae Miltiorrhizae 215g, Radix Astragali 412g, Rhizoma Alismatis 128g, Radix Notoginseng 144g, Flos Sophorae 78g, Ramulus Cinnamomi 156g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 32Mpa, extraction temperature 31 DEG C, separator pressure 16Mpa, separator temperature 46 DEG C, disengaging time 3.3 hours, carbon dioxide flow 27L per hour, obtains extracting solution; Get extracting solution 69 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 XIAOSHUAN TONGLUO JIAONANG 1100.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make XIAOSHUAN TONGLUO JIAONANG.Actual effect of the present invention is investigated below with the XIAOSHUAN TONGLUO JIAONANG that embodiment 3 is obtained:
(1) embodiment 3 XIAOSHUAN TONGLUO JIAONANG and contrast disintegration of commercially available XIAOSHUAN TONGLUO JIAONANG
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 XIAOSHUAN TONGLUO JIAONANG and commercially available XIAOSHUAN TONGLUO JIAONANG contrast table disintegration
The above results shows, XIAOSHUAN TONGLUO JIAONANG prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available XIAOSHUAN TONGLUO JIAONANG.
(2) embodiment 3 XIAOSHUAN TONGLUO JIAONANG and the apoplexy of commercially available XIAOSHUAN TONGLUO JIAONANG treatment caused by obstruction of collaterals by blood stasis, disease sees dull expression, speech stuttering puckery, hands and feet coolness, limbs pain; Cerebral infarction and hyperlipemia are shown in above-mentioned patient clinical observation on the therapeutic effect
1 case scenario
Statistics outpatient service and inpatient, observe the apoplexy caused by obstruction of collaterals by blood stasis altogether, disease sees dull expression, speech stuttering puckery, hands and feet coolness, limbs pain; Cerebral infarction and hyperlipemia are shown in above-mentioned patient case 122 example, 58 years old mean age.Patient is divided into two groups, test group takes embodiment 3 XIAOSHUAN TONGLUO JIAONANG, and matched group takes commercially available XIAOSHUAN TONGLUO JIAONANG.
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 XIAOSHUAN TONGLUO JIAONANG and commercially available XIAOSHUAN TONGLUO JIAONANG clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, XIAOSHUAN TONGLUO JIAONANG prepared by the present invention apoplexy caused by treatment obstruction of collaterals by blood stasis, and disease sees dull expression, speech stuttering puckery, hands and feet coolness, limbs pain; When cerebral infarction and hyperlipemia are shown in above-mentioned patient, evident in efficacy higher than commercially available XIAOSHUAN TONGLUO JIAONANG, p < 0.05.

Claims (3)

1. treat the apoplexy caused by obstruction of collaterals by blood stasis, disease sees dull expression, speech stuttering puckery, hands and feet coolness, limbs pain; Cerebral infarction and hyperlipemia are shown in the Chinese medicine of above-mentioned patient, it is characterized in that getting Herba Pogostemonis 15.6g, Pericarpium Granati 78g, Semen Coicis 104g, Fructus Piperis Longi 156g, Rhizoma Chuanxiong 287g, Radix Salviae Miltiorrhizae 215g, Radix Astragali 412g, Rhizoma Alismatis 128g, Radix Notoginseng 144g, Flos Sophorae 78g, Ramulus Cinnamomi 156g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 19 ~ 44Mpa, extraction temperature 24 ~ 37 DEG C, separator pressure 11 ~ 20Mpa, separator temperature 41 ~ 51 DEG C, disengaging time 2.6 ~ 3.9 hours, carbon dioxide flow 21 ~ 32L per hour, obtains extracting solution; Get extracting solution 62 ~ 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 XIAOSHUAN TONGLUO JIAONANG.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Herba Pogostemonis 15.6g, Pericarpium Granati 78g, Semen Coicis 104g, Fructus Piperis Longi 156g, Rhizoma Chuanxiong 287g, Radix Salviae Miltiorrhizae 215g, Radix Astragali 412g, Rhizoma Alismatis 128g, Radix Notoginseng 144g, Flos Sophorae 78g, Ramulus Cinnamomi 156g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 19 ~ 44Mpa, extraction temperature 24 ~ 37 DEG C, separator pressure 11 ~ 20Mpa, separator temperature 41 ~ 51 DEG C, disengaging time 2.6 ~ 3.9 hours, carbon dioxide flow 21 ~ 32L per hour, obtains extracting solution; Get extracting solution 62 ~ 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 XIAOSHUAN TONGLUO JIAONANG.
3. the preparation method of Chinese medicine according to claim 1, gets Herba Pogostemonis 15.6g, Pericarpium Granati 78g, Semen Coicis 104g, Fructus Piperis Longi 156g, Rhizoma Chuanxiong 287g, Radix Salviae Miltiorrhizae 215g, Radix Astragali 412g, Rhizoma Alismatis 128g, Radix Notoginseng 144g, Flos Sophorae 78g, Ramulus Cinnamomi 156g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 32Mpa, extraction temperature 31 DEG C, separator pressure 16Mpa, separator temperature 46 DEG C, disengaging time 3.3 hours, carbon dioxide flow 27L per hour, obtains extracting solution; Get extracting solution 69 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 XIAOSHUAN TONGLUO JIAONANG.
CN201510905092.2A 2015-12-10 2015-12-10 Embolism eliminating and collateral dredging capsules and preparing method thereof Pending CN105343677A (en)

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