CN105412748A - Anti-tuberculosis capsules and preparation method thereof - Google Patents

Anti-tuberculosis capsules and preparation method thereof Download PDF

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Publication number
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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capsules
carbon dioxide
ground
kanglao
extracting solution
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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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Priority to CN201510948820.8A priority Critical patent/CN105412748A/en
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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)
  • Botany (AREA)
  • 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

A kind of Kanglao Capsules and preparation method thereof
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.
CN201510948820.8A 2015-12-18 2015-12-18 Anti-tuberculosis capsules and preparation method thereof Pending CN105412748A (en)

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