CN105412748A - Anti-tuberculosis capsules and preparation method thereof - Google Patents
Anti-tuberculosis capsules and preparation method thereof Download PDFInfo
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- CN105412748A CN105412748A CN201510948820.8A CN201510948820A CN105412748A CN 105412748 A CN105412748 A CN 105412748A CN 201510948820 A CN201510948820 A CN 201510948820A CN 105412748 A CN105412748 A CN 105412748A
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- 239000002775 capsule Substances 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 9
- 230000002365 anti-tubercular Effects 0.000 title abstract 5
- 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
- 238000000194 supercritical-fluid extraction Methods 0.000 claims abstract description 8
- 239000006071 cream Substances 0.000 claims description 21
- 239000000843 powder Substances 0.000 claims description 21
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 16
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 14
- 238000002156 mixing Methods 0.000 claims description 14
- 239000009636 Huang Qi Substances 0.000 claims description 9
- 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 8
- 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
- 229930195725 Mannitol Natural products 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
- 239000000594 mannitol Substances 0.000 claims description 8
- 235000010355 mannitol 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
- 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
- 230000007812 deficiency Effects 0.000 claims description 7
- 239000000284 extract Substances 0.000 claims description 7
- 238000000605 extraction Methods 0.000 claims description 7
- 239000008187 granular material Substances 0.000 claims description 7
- 238000000227 grinding Methods 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 7
- 239000002245 particle Substances 0.000 claims description 7
- 238000005550 wet granulation Methods 0.000 claims description 7
- 206010011224 Cough Diseases 0.000 claims description 6
- 239000008280 blood Substances 0.000 claims description 6
- 210000004369 blood Anatomy 0.000 claims description 6
- 206010036790 Productive cough Diseases 0.000 claims description 5
- 208000013116 chronic cough Diseases 0.000 claims description 5
- 239000003814 drug Substances 0.000 claims description 5
- 210000004072 lung Anatomy 0.000 claims description 5
- 208000024794 sputum Diseases 0.000 claims description 5
- 210000003802 sputum Anatomy 0.000 claims description 5
- 230000000694 effects Effects 0.000 abstract description 7
- 239000002994 raw material Substances 0.000 abstract description 4
- 241000045403 Astragalus propinquus Species 0.000 abstract description 3
- 235000006533 astragalus Nutrition 0.000 abstract description 3
- 241000471262 Ardisia japonica Species 0.000 abstract description 2
- 235000008708 Morus alba Nutrition 0.000 abstract description 2
- 240000000249 Morus alba Species 0.000 abstract description 2
- 241001671204 Stemona Species 0.000 abstract 1
- 230000003116 impacting effect Effects 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
- 241001078983 Tetradium ruticarpum Species 0.000 description 3
- 235000013399 edible fruits Nutrition 0.000 description 3
- 230000010354 integration Effects 0.000 description 3
- 241000196324 Embryophyta Species 0.000 description 2
- 238000009835 boiling Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 206010062717 Increased upper airway secretion Diseases 0.000 description 1
- 241000218231 Moraceae Species 0.000 description 1
- 241000233855 Orchidaceae Species 0.000 description 1
- 241001671203 Stemona japonica Species 0.000 description 1
- 241000417534 Stemona sessilifolia Species 0.000 description 1
- 241000411860 Stemona tuberosa Species 0.000 description 1
- 241000244978 Stemonaceae Species 0.000 description 1
- 206010053615 Thermal burn Diseases 0.000 description 1
- 229940126678 chinese medicines Drugs 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 230000006837 decompression Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000002349 favourable effect 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
- 208000026435 phlegm Diseases 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000003813 thin hair Effects 0.000 description 1
Classifications
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
-
- 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)
- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
- A61K36/605—Morus (mulberry)
-
- 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)
- A61K36/754—Evodia
-
- 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)
- A61K36/898—Orchidaceae (Orchid family)
-
- 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)
- A61K36/904—Stemonaceae (Stemona family), e.g. croomia
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- 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
- A61K2236/30—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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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
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- Medical Informatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses anti-tuberculosis capsules and a preparation method thereof. The anti-tuberculosis capsules are characterized by being prepared by taking 180g of astragalus membranaceus, 54g of fructus evodiae, 324g of Japanese ardisia herb, 108g of the tuber of stemona, 108g of rhizoma bletillae and 60g of white mulberry root bark, extracting the raw materials with a carbon dioxide supercritical extraction method, decompressing and drying, crushing the raw materials into nano dry paste with a high-energy nano impacting mill, and adding functional auxiliary materials. Compared with commercially available anti-tuberculosis capsules, the disintegration time of the anti-tuberculosis capsules is remarkably shortened and the curative effect is remarkably better, so that the active effect is obtained.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Kanglao Capsules and preparation method thereof.
Background technology
Kanglao Capsules dissipating blood stasis stops blooding, expelling phlegm for arresting cough.For chronic cough of deficiency lung, sputum mixed with blood.Commercially available Kanglao Capsules is due to prescription and technological reason, and curative effect is not satisfactory, and preparation adopts traditional handicraft preparation, there is the deficiencies such as prolonged disintegration, curative effect are low.
Summary of the invention
The present invention, for overcoming above-mentioned deficiency, provides Kanglao Capsules that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Radix Astragali 180g, Fructus Evodiae 54g, Herba Ardisiae Japonicae 324g, Radix Stemonae 108g, Pseudobulbus Bletillae (Rhizoma Bletillae) 108g, Cortex Mori 60g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 18 ~ 38Mpa, extraction temperature 20 ~ 36 DEG C, separator pressure 13 ~ 18Mpa, separator temperature 43 ~ 57 DEG C, disengaging time 2.3 ~ 3.2 hours, carbon dioxide flow 25 ~ 33L per hour, obtains extracting solution; Get extracting solution 61 ~ 78 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 Kanglao Capsules 700.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
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.
Fructus Evodiae: China's coastal port one ministerial standard.This product is luxuriant growth savoury herb Fructus Evodiae Evodiarutaecarpa(Juss.) Benth., Shi Hu Evodiarutaecarpa(Juss.) Benth.var.officina-lis(Dode) Huang or thin hair Fructus Evodiae Evodiarutaecarpa(Juss.) Benth.var.bodinieri(Dode) the dry almost ripe fruit of Huang.When the 8-11 month, fruit not yet ftractureed, cut Fruit branch, dry or cold drying. except impurity such as debranching, leaf, carpopodiums.
Herba Ardisiae Japonicae: China's coastal port one ministerial standard.This product is Myrsinacea plant Herba Ardisiae Japonicae Ardisiajaponica(Tbunb.) the dry herb of Blume.Summer, autumn two excavate when season, stem and leaf was luxuriant, removing silt, dry.
The Radix Stemonae: China's coastal port one ministerial standard.This product is Stemonaceae plant Radix Stemonae Stemonasessilifolia (Miq.) Miq., Radix stemonae japonicae Stemonajaponica(Bl.) dried root of Miq. or radix stemonae tuberosae StemonatuberosaLour..Spring, Qiu Erji excavate. removing fibrous root, and clean, put in boiling water and slightly scald or steam to without the white heart, take out, dry.
Pseudobulbus Bletillae (Rhizoma Bletillae): China's coastal port one ministerial standard.This product is orchid Pseudobulbus Bletillae (Rhizoma Bletillae) Bletillastriafa(Thunb.) drying of Reichb.f. determines stem.Summer, Qiu Erji dig, and removing fibrous root, cleans, and put in boiling water and boil or steam to without the white heart, shine to half-dried, removing crust, dries.
Cortex Mori: China's coastal port one ministerial standard.This product is the dry root bark of moraceae plants Mulberry MirusalbaL..Fall last years of a century in autumn and excavate root before secondary spring germinates, scrape off yellowish-brown rough bark. longitudinally cut open. strip root bark, 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 Kanglao Capsules all can be bought from pharmaceuticals and obtain, and all can be used to implement the present invention program as long as meet national standard.
In foregoing invention scheme, term used is pharmacy proprietary term, as " decompression " etc. all defers to Chinese Pharmacopoeia regulation and pharmaceutical practice of being correlated with.
Unit g in the present invention also can be other weight portion, does not affect the enforcement of the present invention program.
Equipment Market described in the present invention program all has sale, is not limited to typical production producer, as long as technical specification can reach requirement, all can be used to realize the present invention.
Detailed description of the invention
Specific embodiments of the invention 1
Get Radix Astragali 180g, Fructus Evodiae 54g, Herba Ardisiae Japonicae 324g, Radix Stemonae 108g, Pseudobulbus Bletillae (Rhizoma Bletillae) 108g, Cortex Mori 60g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 18Mpa, extraction temperature 20 DEG C, separator pressure 13Mpa, separator temperature 43 DEG C, disengaging time 2.3 hours, carbon dioxide flow 25L per hour, obtains extracting solution; Get extracting solution 61 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 Kanglao Capsules 700.
Specific embodiments of the invention 2
Get Radix Astragali 180g, Fructus Evodiae 54g, Herba Ardisiae Japonicae 324g, Radix Stemonae 108g, Pseudobulbus Bletillae (Rhizoma Bletillae) 108g, Cortex Mori 60g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 38Mpa, extraction temperature 36 DEG C, separator pressure 18Mpa, separator temperature 57 DEG C, disengaging time 3.2 hours, carbon dioxide flow 33L 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 Kanglao Capsules 700.
Specific embodiments of the invention 3
Get Radix Astragali 180g, Fructus Evodiae 54g, Herba Ardisiae Japonicae 324g, Radix Stemonae 108g, Pseudobulbus Bletillae (Rhizoma Bletillae) 108g, Cortex Mori 60g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 28Mpa, extraction temperature 28 DEG C, separator pressure 16Mpa, separator temperature 50 DEG C, disengaging time 2.8 hours, carbon dioxide flow 29L 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 Kanglao Capsules 700.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make Kanglao Capsules.Actual effect of the present invention is investigated below with the Kanglao Capsules that embodiment 3 is obtained:
(1) embodiment 3 Kanglao Capsules and contrast disintegration of commercially available Kanglao Capsules
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 Kanglao Capsules and commercially available Kanglao Capsules contrast table disintegration
The above results shows, Kanglao Capsules prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available Kanglao Capsules.
(2) embodiment 3 Kanglao Capsules and commercially available Kanglao Capsules treatment chronic cough of deficiency lung, sputum mixed with blood clinical observation on the therapeutic effect
1 case scenario
Statistics outpatient service and inpatient, observe chronic cough of deficiency lung altogether, sputum mixed with blood case 124 example, 47 years old mean age.Patient is divided into two groups, test group takes embodiment 3 Kanglao Capsules, and matched group takes commercially available Kanglao Capsules.
2 efficacy assessment standards
According to new Chinese medicine treatment guideline of clinical investigations tcm syndrome curative effect determinate standard:
Clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.
Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%.
Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%.
Invalid: tcm clinical practice symptom, sign are all not improved or increase the weight of, syndrome integral reduces < 30%.
Computing formula: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
3 clinical observation result
Table 2 embodiment 3 Kanglao Capsules and commercially available Kanglao Capsules clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, Kanglao Capsules prepared by the present invention is at treatment chronic cough of deficiency lung, during sputum mixed with blood, evident in efficacy higher than commercially available Kanglao Capsules, p < 0.05.
Claims (3)
1. treat a chronic cough of deficiency lung, the Chinese medicine of sputum mixed with blood, is characterized in that getting Radix Astragali 180g, Fructus Evodiae 54g, Herba Ardisiae Japonicae 324g, Radix Stemonae 108g, Pseudobulbus Bletillae (Rhizoma Bletillae) 108g, Cortex Mori 60g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 18 ~ 38Mpa, extraction temperature 20 ~ 36 DEG C, separator pressure 13 ~ 18Mpa, separator temperature 43 ~ 57 DEG C, disengaging time 2.3 ~ 3.2 hours, carbon dioxide flow 25 ~ 33L per hour, obtains extracting solution; Get extracting solution 61 ~ 78 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 Kanglao Capsules.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Radix Astragali 180g, Fructus Evodiae 54g, Herba Ardisiae Japonicae 324g, Radix Stemonae 108g, Pseudobulbus Bletillae (Rhizoma Bletillae) 108g, Cortex Mori 60g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 18 ~ 38Mpa, extraction temperature 20 ~ 36 DEG C, separator pressure 13 ~ 18Mpa, separator temperature 43 ~ 57 DEG C, disengaging time 2.3 ~ 3.2 hours, carbon dioxide flow 25 ~ 33L per hour, obtains extracting solution; Get extracting solution 61 ~ 78 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 Kanglao Capsules.
3. the preparation method of Chinese medicine according to claim 1, gets Radix Astragali 180g, Fructus Evodiae 54g, Herba Ardisiae Japonicae 324g, Radix Stemonae 108g, Pseudobulbus Bletillae (Rhizoma Bletillae) 108g, Cortex Mori 60g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 28Mpa, extraction temperature 28 DEG C, separator pressure 16Mpa, separator temperature 50 DEG C, disengaging time 2.8 hours, carbon dioxide flow 29L 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 Kanglao Capsules.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510948820.8A CN105412748A (en) | 2015-12-18 | 2015-12-18 | Anti-tuberculosis capsules and preparation method thereof |
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| CN201510948820.8A CN105412748A (en) | 2015-12-18 | 2015-12-18 | Anti-tuberculosis capsules and preparation method thereof |
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