CN105343303A - Xuefuzhuyu soft capsule and preparation method thereof - Google Patents
Xuefuzhuyu soft capsule and preparation method thereof Download PDFInfo
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- CN105343303A CN105343303A CN201510864843.0A CN201510864843A CN105343303A CN 105343303 A CN105343303 A CN 105343303A CN 201510864843 A CN201510864843 A CN 201510864843A CN 105343303 A CN105343303 A CN 105343303A
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 11
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims abstract description 30
- 238000001035 drying Methods 0.000 claims abstract description 17
- 229910002092 carbon dioxide Inorganic materials 0.000 claims abstract description 15
- 239000001569 carbon dioxide Substances 0.000 claims abstract description 15
- 238000000034 method Methods 0.000 claims abstract description 9
- 238000000605 extraction Methods 0.000 claims abstract description 8
- 238000000194 supercritical-fluid extraction Methods 0.000 claims abstract description 8
- 239000010056 xuefu Substances 0.000 claims description 29
- 239000000843 powder Substances 0.000 claims description 18
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 16
- 239000006071 cream Substances 0.000 claims description 15
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 14
- 238000002156 mixing Methods 0.000 claims description 11
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 8
- 229920002472 Starch Polymers 0.000 claims description 8
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 8
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 8
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 8
- 238000004132 cross linking Methods 0.000 claims description 8
- 235000019359 magnesium stearate Nutrition 0.000 claims description 8
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 8
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 8
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 8
- 210000000582 semen Anatomy 0.000 claims description 8
- 239000011734 sodium Substances 0.000 claims description 8
- 229910052708 sodium Inorganic materials 0.000 claims description 8
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 8
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 8
- 239000008107 starch Substances 0.000 claims description 8
- 235000019698 starch Nutrition 0.000 claims description 8
- 206010013786 Dry skin Diseases 0.000 claims description 7
- 239000000284 extract Substances 0.000 claims description 7
- 239000008187 granular material Substances 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 7
- 238000005550 wet granulation Methods 0.000 claims description 7
- 206010002368 Anger Diseases 0.000 claims description 5
- 206010008479 Chest Pain Diseases 0.000 claims description 5
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 5
- 206010019233 Headaches Diseases 0.000 claims description 5
- 206010049976 Impatience Diseases 0.000 claims description 5
- 229930195725 Mannitol Natural products 0.000 claims description 5
- 206010033557 Palpitations Diseases 0.000 claims description 5
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 claims description 5
- 206010047513 Vision blurred Diseases 0.000 claims description 5
- 239000003814 drug Substances 0.000 claims description 5
- 231100000869 headache Toxicity 0.000 claims description 5
- 206010022437 insomnia Diseases 0.000 claims description 5
- 239000000594 mannitol Substances 0.000 claims description 5
- 235000010355 mannitol Nutrition 0.000 claims description 5
- 238000000227 grinding Methods 0.000 claims description 4
- 239000002245 particle Substances 0.000 claims description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 3
- 230000000694 effects Effects 0.000 abstract description 8
- 239000002994 raw material Substances 0.000 abstract description 3
- 244000144730 Amygdalus persica Species 0.000 abstract description 2
- 241000382455 Angelica sinensis Species 0.000 abstract description 2
- 235000006753 Platycodon grandiflorum Nutrition 0.000 abstract description 2
- 230000006837 decompression Effects 0.000 abstract description 2
- 244000274050 Platycodon grandiflorum Species 0.000 abstract 1
- 244000292697 Polygonum aviculare Species 0.000 abstract 1
- 235000006386 Polygonum aviculare Nutrition 0.000 abstract 1
- 235000006040 Prunus persica var persica Nutrition 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 208000011580 syndromic disease Diseases 0.000 description 5
- 208000024891 symptom Diseases 0.000 description 4
- 230000010354 integration Effects 0.000 description 3
- 241000196324 Embryophyta Species 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 230000003760 hair shine Effects 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 235000011446 Amygdalus persica Nutrition 0.000 description 1
- 241000202726 Bupleurum Species 0.000 description 1
- 241000208671 Campanulaceae Species 0.000 description 1
- 244000183685 Citrus aurantium Species 0.000 description 1
- 241000125183 Crithmum maritimum Species 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 241000013557 Plantaginaceae Species 0.000 description 1
- 240000003582 Platycodon grandiflorus Species 0.000 description 1
- 240000002381 Prunus davidiana Species 0.000 description 1
- 235000013527 bean curd Nutrition 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 229940126678 chinese medicines Drugs 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 230000004345 fruit ripening Effects 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
Classifications
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- 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)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
-
- 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
- A61K36/232—Angelica
-
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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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/233—Bupleurum
-
- 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
- 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)
- A61K36/34—Campanulaceae (Bellflower 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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
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- 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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/714—Aconitum (monkshood)
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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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
-
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/752—Citrus, e.g. lime, orange or lemon
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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)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
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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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- 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
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- 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 xuefuzhuyu soft capsule and a preparation method thereof. The xuefuzhuyu soft capsule and the preparation method thereof are characterized in that 75 g of polygonum aviculare, 66.6 g of radix aconiti preparata, 200 g of peach seeds, 150 g of angelica sinensis, 100 g of fructus aurantii (stir-baking with bran), 75 g of rhizoma chuanxiong, 45 g of radix burpleuri, 180 g of radix achyranthis bidentatae, 130 g of radix rehmanniae and 85 g of platycodon grandiflorum are taken, extraction is conducted through a carbon dioxide supercritical extraction method, decompression drying is conducted, a high-energy nano impact mill is utilized to smash the raw materials into nano dry paste, functional auxiliary materials are added, and the xuefuzhuyu soft capsule is prepared. The disintegration time is obviously shortened, the curative effect is significantly superior to that of a commercially available xuefuzhuyu soft capsule, and the active effect is achieved.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Xuefu Zhuyu soft capsule and preparation method thereof.
Background technology
Xuefu Zhuyu soft capsule blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain.For blood-stasis internal-depression, headache or chest pain, interior-heat blurring of vision accompanied with oppressive feeling, insomnia and dreamful sleep, severe palpitation, impatience and irascibility.Commercially available Xuefu Zhuyu soft 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 Xuefu Zhuyu soft capsule that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Qu Herba Polygoni Avicularis 75g, Radix Aconiti Preparata 66.6g, Semen Persicae 200g, Radix Angelicae Sinensis 150g, Fructus Aurantii (parched with bran) 100g, Rhizoma Chuanxiong 75g, Radix Bupleuri 45g, Radix Achyranthis Bidentatae 180g, Radix Rehmanniae 130g, Radix Platycodonis 85g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 19 ~ 42Mpa, extraction temperature 19 ~ 38 DEG C, separator pressure 11 ~ 19Mpa, separator temperature 43 ~ 52 DEG C, disengaging time 2.4 ~ 3.5 hours, carbon dioxide flow 27 ~ 32L per hour, obtains extracting solution; Get extracting solution 60 ~ 78 DEG C of drying under reduced pressure, get dry extract; 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 Xuefu Zhuyu soft capsule 1250.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
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.
Radix Aconiti Preparata: China's coastal port one ministerial standard.This product is the Preparation process product of Radix Aconiti.
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.
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.
Fructus Aurantii: China's coastal port one ministerial standard.This product is the dry immature fruit of rutaceae Citrus aurantium Linn. CitrusaurantiumL. and variety thereof.July gathers when peel is still green, is two halves from middle part crosscut, dries or cold drying.
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 Bupleuri: China's coastal port one ministerial standard.This product is the dry root of umbelliferae bupleurum BupleurumchinenseDC. or Radix Bupeuri Scorzonerfolii. BupleurumscocrzonerifoliumWilld..Different by character, practise title " Radix Bupleuri " and " Radix Bupleuri Scorzonerifolii " respectively.Spring, Qiu Erji excavate, removing stem and leaf and silt, dry.
Radix Achyranthis Bidentatae: China's coastal port one ministerial standard.This product is the dry root of amaranthaceous plant Radix Achyranthis Bidentatae AchyranthesbidentataBl..Excavate when winter, stem and leaf was withered, removing fibrous root and silt, be bundled into wisp, shines as after wrinkle, trimmed on top, dry.
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 ".
Radix Platycodonis: China's coastal port one ministerial standard.This product is Campanulaceae Radix Platycodonis Platycodongrandiflorum(Jacq.) dry root of ADC..Spring, Qiu Erji excavate, and clean, and removing fibrous root, takes advantage of and freshly peel off crust or do not remove crust, 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 Xuefu Zhuyu soft capsule 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 ", " parched with bran " etc. all defer 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
Qu Herba Polygoni Avicularis 75g, Radix Aconiti Preparata 66.6g, Semen Persicae 200g, Radix Angelicae Sinensis 150g, Fructus Aurantii (parched with bran) 100g, Rhizoma Chuanxiong 75g, Radix Bupleuri 45g, Radix Achyranthis Bidentatae 180g, Radix Rehmanniae 130g, Radix Platycodonis 85g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 19Mpa, extraction temperature 19 DEG C, separator pressure 11Mpa, separator temperature 43 DEG C, disengaging time 2.4 hours, carbon dioxide flow 27L per hour, obtains extracting solution; Get extracting solution 60 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 Xuefu Zhuyu soft capsule 1250.
Specific embodiments of the invention 2
Qu Herba Polygoni Avicularis 75g, Radix Aconiti Preparata 66.6g, Semen Persicae 200g, Radix Angelicae Sinensis 150g, Fructus Aurantii (parched with bran) 100g, Rhizoma Chuanxiong 75g, Radix Bupleuri 45g, Radix Achyranthis Bidentatae 180g, Radix Rehmanniae 130g, Radix Platycodonis 85g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 42Mpa, extraction temperature 38 DEG C, separator pressure 19Mpa, separator temperature 52 DEG C, disengaging time 3.5 hours, carbon dioxide flow 32L per hour, obtains extracting solution; Get extracting solution 78 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 Xuefu Zhuyu soft capsule 1250.
Specific embodiments of the invention 3
Qu Herba Polygoni Avicularis 75g, Radix Aconiti Preparata 66.6g, Semen Persicae 200g, Radix Angelicae Sinensis 150g, Fructus Aurantii (parched with bran) 100g, Rhizoma Chuanxiong 75g, Radix Bupleuri 45g, Radix Achyranthis Bidentatae 180g, Radix Rehmanniae 130g, Radix Platycodonis 85g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 28 DEG C, separator pressure 15Mpa, separator temperature 48 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 Xuefu Zhuyu soft capsule 1250.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make Xuefu Zhuyu soft capsule.Actual effect of the present invention is investigated below with the Xuefu Zhuyu soft capsule that embodiment 3 is obtained:
(1) embodiment 3 Xuefu Zhuyu soft capsule and contrast disintegration of commercially available Xuefu Zhuyu soft capsule
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 Xuefu Zhuyu soft capsule and commercially available Xuefu Zhuyu soft capsule contrast table disintegration
The above results shows, Xuefu Zhuyu soft capsule prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available Xuefu Zhuyu soft capsule.
(2) embodiment 3 Xuefu Zhuyu soft capsule and commercially available Xuefu Zhuyu soft capsule treatment blood-stasis internal-depression, headache or chest pain, interior-heat blurring of vision accompanied with oppressive feeling, insomnia and dreamful sleep, severe palpitation, impatience and irascibility Disease Clinical observation of curative effect
1 case scenario
Statistics outpatient service and inpatient, observe blood-stasis internal-depression altogether, headache or chest pain, interior-heat blurring of vision accompanied with oppressive feeling, insomnia and dreamful sleep, severe palpitation, impatience and irascibility case 134 example, 49 years old mean age.Patient is divided into two groups, test group takes embodiment 3 Xuefu Zhuyu soft capsule, and matched group takes commercially available Xuefu Zhuyu soft 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
Table 2 embodiment 3 Xuefu Zhuyu soft capsule and commercially available Xuefu Zhuyu soft capsule clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, Xuefu Zhuyu soft capsule prepared by the present invention, at treatment blood-stasis internal-depression, is had a headache or chest pain, interior-heat blurring of vision accompanied with oppressive feeling, insomnia and dreamful sleep, severe palpitation, during impatience and irascibility disease, evident in efficacy higher than commercially available Xuefu Zhuyu soft capsule, p < 0.05.
Claims (3)
1. a treatment blood-stasis internal-depression, headache or chest pain, interior-heat blurring of vision accompanied with oppressive feeling, insomnia and dreamful sleep, severe palpitation, the Chinese medicine of impatience and irascibility disease, it is characterized in that Qu Herba Polygoni Avicularis 75g, Radix Aconiti Preparata 66.6g, Semen Persicae 200g, Radix Angelicae Sinensis 150g, Fructus Aurantii (parched with bran) 100g, Rhizoma Chuanxiong 75g, Radix Bupleuri 45g, Radix Achyranthis Bidentatae 180g, Radix Rehmanniae 130g, Radix Platycodonis 85g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 19 ~ 42Mpa, extraction temperature 19 ~ 38 DEG C, separator pressure 11 ~ 19Mpa, separator temperature 43 ~ 52 DEG C, disengaging time 2.4 ~ 3.5 hours, carbon dioxide flow 27 ~ 32L per hour, obtain extracting solution, get extracting solution 60 ~ 78 DEG C of drying under reduced pressure, get dry extract, 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 Xuefu Zhuyu soft capsule.
2. the preparation method of Chinese medicine according to claim 1, it is characterized in that Qu Herba Polygoni Avicularis 75g, Radix Aconiti Preparata 66.6g, Semen Persicae 200g, Radix Angelicae Sinensis 150g, Fructus Aurantii (parched with bran) 100g, Rhizoma Chuanxiong 75g, Radix Bupleuri 45g, Radix Achyranthis Bidentatae 180g, Radix Rehmanniae 130g, Radix Platycodonis 85g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 19 ~ 42Mpa, extraction temperature 19 ~ 38 DEG C, separator pressure 11 ~ 19Mpa, separator temperature 43 ~ 52 DEG C, disengaging time 2.4 ~ 3.5 hours, carbon dioxide flow 27 ~ 32L per hour, obtains extracting solution; Get extracting solution 60 ~ 78 DEG C of drying under reduced pressure, get dry extract; 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 Xuefu Zhuyu soft capsule.
3. the preparation method , Qu Herba Polygoni Avicularis 75g of Chinese medicine according to claim 1, Radix Aconiti Preparata 66.6g, Semen Persicae 200g, Radix Angelicae Sinensis 150g, Fructus Aurantii (parched with bran) 100g, Rhizoma Chuanxiong 75g, Radix Bupleuri 45g, Radix Achyranthis Bidentatae 180g, Radix Rehmanniae 130g, Radix Platycodonis 85g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 28 DEG C, separator pressure 15Mpa, separator temperature 48 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 Xuefu Zhuyu soft capsule.
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