CN105380923A - Cold curing capsule and preparation method thereof - Google Patents

Cold curing capsule and preparation method thereof Download PDF

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Publication number
CN105380923A
CN105380923A CN201510842236.4A CN201510842236A CN105380923A CN 105380923 A CN105380923 A CN 105380923A CN 201510842236 A CN201510842236 A CN 201510842236A CN 105380923 A CN105380923 A CN 105380923A
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carbon dioxide
ground
extracting solution
pressure
separator
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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 CN201510842236.4A priority Critical patent/CN105380923A/en
Publication of CN105380923A publication Critical patent/CN105380923A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/19Acanthaceae (Acanthus family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/31Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A61K36/315Isatis, e.g. Dyer's woad
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/58Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/716Clematis (leather flower)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/37Extraction 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)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a cold curing capsule and a preparation method thereof. The cold curing capsule is characterized by comprising the following preparation steps: extracting 111 g of radix clematidis, 110 g of tabasheer, 56 g of szechwan Chinaberry fruits, 176 g of radix isatidis, 107 g of folium isatidis, 104 g of black sesame, and 23.6 g of herba andrographitis by adopting a carbon dioxide supercritical extraction method, decompressing, drying, pulverizing into a nano dry cream by using a high-power nano impact mill, adding functional auxiliary materials, so that the cold curing capsule is prepared. The disintegrating time is remarkably shortened, the curative effect is obviously better than that of the commercially-available cold curing capsule, and a positive effect is achieved.

Description

A kind of curing cold capsule and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of curing cold capsule and preparation method thereof.
Background technology
Curing cold capsule dispelling wind to relieve the exterior syndrome, heat-clearing and toxic substances removing.For anemopyretic cold, fever, headache, nasal obstruction watery nasal discharge, sneeze, laryngopharynx swelling and pain, the diseases such as systemic pain.Commercially available curing cold 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 curing cold capsule that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Radix Clematidis 111g, Concretio Silicea Bambusae 110g, Fructus Toosendan 56g, Radix Isatidis 176g, Folium Isatidis 107g, Semen Sesami Nigrum 104g, Herba Andrographis 23.6g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 21 ~ 44Mpa, extraction temperature 17 ~ 41 DEG C, separator pressure 10 ~ 19Mpa, separator temperature 43 ~ 58 DEG C, disengaging time 2.1 ~ 3.6 hours, carbon dioxide flow 24 ~ 37L per hour, obtains extracting solution; Get extracting solution 63 ~ 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained curing cold capsule 1000.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Radix Clematidis: China's coastal port one ministerial standard.This product is the dry root and rhizome of ranunculaceae plant Radix Clematidis ClematischinensisOsbeck, Clematis hexapetala ClematishexapetalaPall. or northeast clematis ClematismanshuricaRupr..Autumn excavates. removing silt. dry.
Concretio Silicea Bambusae: China's coastal port one ministerial standard.This product is the dried block of juice in the stalk such as grass Chinese textile bamboo BambusatextilisMcClure or schizostachyum chinense Rendle SchizostachyumchinenseRendle.Autumn, season in winter two receive.
Fructus Toosendan: China's coastal port one ministerial standard.This product is the dry mature fruit of spy section plant Fructus Toosendan MeliatoosendanSleb.etZucc..Gather during fruit maturation in winter, removing impurity, dry.
Radix Isatidis: China's coastal port one ministerial standard.This product is the dry root of cruciferae isatis IsatisindigoticaFort..Autumn digs, and removing silt, dries.
Folium Isatidis: Chinese Pharmacopoeia version one ministerial standard in 2015.This product is cruciferae isatis isatisindigoticafort. dried leaves.In the summer, divide in season in autumn two and gather for 23 times, removing impurity, dries.
Semen Sesami Nigrum: China's coastal port one ministerial standard.This product is the dry mature seed of Pedaliaceae plant sesame SesamumindicumL..Plant is tapped during fruit maturation in autumn. dry, lay seed, removing impurity, then dry.
Herba Andrographis: China's coastal port one ministerial standard.This product is acanthaceous plant Herba Andrographis Andrographispaniculata(Burm.f.) dry aerial parts of Nees.Tap when at the beginning of autumn, stem and leaf is luxuriant. 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 curing cold 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 " etc. all defers to Chinese Pharmacopoeia regulation and pharmaceutical practice of being correlated with.
Unit g in the present invention also can be other weight portion, does not affect the enforcement of the present invention program.
Equipment Market described in the present invention program all has sale, is not limited to typical production producer, as long as technical specification can reach requirement, all can be used to realize the present invention.
Four detailed description of the invention
Specific embodiments of the invention 1
Get Radix Clematidis 111g, Concretio Silicea Bambusae 110g, Fructus Toosendan 56g, Radix Isatidis 176g, Folium Isatidis 107g, Semen Sesami Nigrum 104g, Herba Andrographis 23.6g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 21Mpa, extraction temperature 17 DEG C, separator pressure 10Mpa, separator temperature 43 DEG C, disengaging time 2.1 hours, carbon dioxide flow 24L per hour, obtains extracting solution; Get extracting solution 63 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 curing cold capsule 1000.
Specific embodiments of the invention 2
Get Radix Clematidis 111g, Concretio Silicea Bambusae 110g, Fructus Toosendan 56g, Radix Isatidis 176g, Folium Isatidis 107g, Semen Sesami Nigrum 104g, Herba Andrographis 23.6g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 44Mpa, extraction temperature 41 DEG C, separator pressure 19Mpa, separator temperature 58 DEG C, disengaging time 3.6 hours, carbon dioxide flow 37L per hour, obtains extracting solution; Get extracting solution 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 55g, crospolyvinylpyrrolidone 55g, cross-linking sodium carboxymethyl cellulose 45g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional carboxymethyl starch sodium 9g, magnesium stearate 3g, granulate, incapsulates, obtained curing cold capsule 1000.
Specific embodiments of the invention 3
Get Radix Clematidis 111g, Concretio Silicea Bambusae 110g, Fructus Toosendan 56g, Radix Isatidis 176g, Folium Isatidis 107g, Semen Sesami Nigrum 104g, Herba Andrographis 23.6g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 33Mpa, extraction temperature 30 DEG C, separator pressure 15Mpa, separator temperature 50 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 curing cold capsule 1000.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make curing cold capsule.Actual effect of the present invention is investigated below with the curing cold capsule that embodiment 3 is obtained:
(1) embodiment 3 curing cold capsule and contrast disintegration of commercially available curing cold capsule
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 curing cold capsule and commercially available curing cold capsule contrast table disintegration
The above results shows, curing cold capsule prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available curing cold capsule.
(2) embodiment 3 curing cold capsule and commercially available curing cold capsule treatment anemopyretic cold, fever, headache, nasal obstruction watery nasal discharge, sneeze, laryngopharynx swelling and pain, the disease clinical observation on the therapeutic effect such as systemic pain
1 case scenario
Statistics outpatient service and inpatient, observe anemopyretic cold altogether, fever, headache, nasal obstruction watery nasal discharge, sneeze, laryngopharynx swelling and pain, disease case 140 examples such as systemic pain, 43 years old mean age.Patient is divided into two groups, test group takes embodiment 3 curing cold capsule, and matched group takes commercially available curing cold 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 curing cold capsule and commercially available curing cold capsule clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, curing cold capsule prepared by the present invention is at treatment anemopyretic cold, and fever, has a headache, nasal obstruction watery nasal discharge, sneeze, laryngopharynx swelling and pain, during the diseases such as systemic pain, evident in efficacy higher than commercially available curing cold capsule, p < 0.05.

Claims (3)

1. a treatment anemopyretic cold, fever, headache, nasal obstruction watery nasal discharge, sneeze, laryngopharynx swelling and pain, the Chinese medicine of the diseases such as systemic pain, it is characterized in that getting Radix Clematidis 111g, Concretio Silicea Bambusae 110g, Fructus Toosendan 56g, Radix Isatidis 176g, Folium Isatidis 107g, Semen Sesami Nigrum 104g, Herba Andrographis 23.6g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 21 ~ 44Mpa, extraction temperature 17 ~ 41 DEG C, separator pressure 10 ~ 19Mpa, separator temperature 43 ~ 58 DEG C, disengaging time 2.1 ~ 3.6 hours, carbon dioxide flow 24 ~ 37L per hour, obtain extracting solution, get extracting solution 63 ~ 77 DEG C of drying under reduced pressure, get dry extract, get dry cream and add mannitol 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm, get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained curing cold capsule.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Radix Clematidis 111g, Concretio Silicea Bambusae 110g, Fructus Toosendan 56g, Radix Isatidis 176g, Folium Isatidis 107g, Semen Sesami Nigrum 104g, Herba Andrographis 23.6g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 21 ~ 44Mpa, extraction temperature 17 ~ 41 DEG C, separator pressure 10 ~ 19Mpa, separator temperature 43 ~ 58 DEG C, disengaging time 2.1 ~ 3.6 hours, carbon dioxide flow 24 ~ 37L per hour, obtains extracting solution; Get extracting solution 63 ~ 77 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add mannitol 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained curing cold capsule.
3. the preparation method of Chinese medicine according to claim 1, gets Radix Clematidis 111g, Concretio Silicea Bambusae 110g, Fructus Toosendan 56g, Radix Isatidis 176g, Folium Isatidis 107g, Semen Sesami Nigrum 104g, Herba Andrographis 23.6g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 33Mpa, extraction temperature 30 DEG C, separator pressure 15Mpa, separator temperature 50 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 curing cold capsule.
CN201510842236.4A 2015-11-29 2015-11-29 Cold curing capsule and preparation method thereof Pending CN105380923A (en)

Priority Applications (1)

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Application Number Priority Date Filing Date Title
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CN105380923A true CN105380923A (en) 2016-03-09

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Application publication date: 20160309