CN104474384A - Fuganning tablet and preparation method thereof - Google Patents

Fuganning tablet and preparation method thereof Download PDF

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Publication number
CN104474384A
CN104474384A CN201410702359.3A CN201410702359A CN104474384A CN 104474384 A CN104474384 A CN 104474384A CN 201410702359 A CN201410702359 A CN 201410702359A CN 104474384 A CN104474384 A CN 104474384A
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Prior art keywords
fuganning
ground
carbon dioxide
pian
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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Publication of CN104474384A publication Critical patent/CN104474384A/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)
    • A61K36/19—Acanthaceae (Acanthus family)
    • A61K36/195—Strobilanthes
    • 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
    • A61K36/233—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)
    • A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A61K36/315—Isatis, e.g. Dyer's woad
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • 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)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • 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)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8998—Hordeum (barley)
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • A61K2236/50—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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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Botany (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention discloses a Fuganning tablet and a preparation method thereof. The preparation method is characterized by comprising the following steps: extracting 120g of angelica pubescens, 80g of lysimachia christinae hance, 114g of radix isatidis, 45g of malt, 68g of radix bupleuri and 68g of moutan bark by adopting a carbon dioxide supercritical extraction method; drying at reduced pressure, and grinding into nano-dry extract by virtue of a high-energy nano-impact mill; and adding functional auxiliaries to prepare the Fuganning tablet. The Fuganning tablet can be used for greatly shortening the disintegrating time, and has a curative effect which is remarkably superior to that of commercially available Fuganning tablets, so that a positive effect is achieved.

Description

A kind of FUGANNING PIAN and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of FUGANNING PIAN and preparation method thereof.
Background technology
FUGANNING PIAN the liver soothing and the spleen invigorating, clearing away heat-damp and promoting diuresis.Belong to liver-yang hyperactivity for HBS anti-positive insufficiency of the spleen, pyretic toxicity is Sheng person comparatively.Commercially available FUGANNING PIAN 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 FUGANNING PIAN that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Radix Angelicae Pubescentis 120g, Herba Lysimachiae 80g, Radix Isatidis 114g, Fructus Hordei Germinatus 45g, Radix Bupleuri 68g, Cortex Moutan 68g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add fructose 80 ~ 120g, 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 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, be pressed into 1000, obtained FUGANNING PIAN.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Radix Angelicae Pubescentis: China's coastal port one ministerial standard.This product is the dry root of samphire Angelica pubescens Angelica pubescensMaxim.f.biserrata Shan et Yuan.Excavate when Seedling at the beginning of spring has just germinateed or autumn Mo, stem and leaf was withered, removing fibrous root and silt, be dried to half-dried, bank up 2-3 days, is dried to absolutely dry after feeling like jelly again.
The Rhizoma Atractylodis Macrocephalae: China's coastal port one ministerial standard.This product is the dry rhizome of feverfew Rhizoma Atractylodis Macrocephalae Atractylodes macrocephala Koldz..Excavate when withered and yellow, the upper leaf of inferior leads in winter becomes fragile, removing silt, dries or dries, then remove fibrous root.
Herba Lysimachiae: China's coastal port one ministerial standard.This product is the dry herb of Ofthe Primulaceae Lysimachia christinae Hance Lysimachia christinaeHance.Summer, Qiu Erji receive, and removing impurity, dries.
Radix Isatidis: China's coastal port one ministerial standard.This product is the dry root of cruciferae isatis Isatis indigotica Fort..Autumn digs, and removing silt, dries.
Fructus Hordei Germinatus: China's coastal port one ministerial standard.This product is that the mature fruit of grass Fructus Hordei Vulgaris Hordeum vulgarE L. obtains through drying of germinateing.After wheat grain is soaked in water, keeps suitable epidemic disaster, when plumelet grows to about 0.5cm, dry or cold drying.
Radix Bupleuri: China's coastal port one ministerial standard.This product is the dry root of umbelliferae bupleurum Bupleurum chinense DC. or Radix Bupeuri Scorzonerfolii. Bupleurum scocrzonerifolium Willd..Different by character, practise title " Radix Bupleuri " and " Radix Bupleuri Scorzonerifolii " respectively.Spring, Qiu Erji excavate, removing stem and leaf and silt, dry.
Cortex Moutan: China's coastal port one ministerial standard.This product is the dry root bark of ranunculaceae peony Paeonia suffruticosa Andr..Autumn excavates root, and removing radicula and silt, strip root bark, dry.
Fructose: 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.
Hypromellose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Micropowder silica gel: Chinese Pharmacopoeia version two ministerial standard in 2010.
Leucine: Chinese Pharmacopoeia version two ministerial standard in 2010.
Raw material used by above FUGANNING PIAN 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 Angelicae Pubescentis 120g, Herba Lysimachiae 80g, Radix Isatidis 114g, Fructus Hordei Germinatus 45g, Radix Bupleuri 68g, Cortex Moutan 68g, be ground into 60 order coarse powder, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 20Mpa, extraction temperature 20 DEG C, separator pressure 15Mpa, separator temperature 40 DEG C, disengaging time 2 hours, carbon dioxide flow 20L per hour, obtains extracting solution; Get extracting solution 60 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add fructose 80g, 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 35g, crospolyvinylpyrrolidone 35g, cross-linking sodium carboxymethyl cellulose 35g, hypromellose 25g, micropowder silica gel 15g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional leucine 7g, granulate, is pressed into 1000, obtained FUGANNING PIAN.
Specific embodiments of the invention 2
Get Radix Angelicae Pubescentis 120g, Herba Lysimachiae 80g, Radix Isatidis 114g, Fructus Hordei Germinatus 45g, Radix Bupleuri 68g, Cortex Moutan 68g, be ground into 60 order coarse powder, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 40Mpa, extraction temperature 40 DEG C, separator pressure 25Mpa, separator temperature 60 DEG C, disengaging time 4 hours, carbon dioxide flow 40L per hour, obtains extracting solution; Get extracting solution 80 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add fructose 120g, 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 45g, hypromellose 35g, micropowder silica gel 25g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional leucine 9g, granulate, is pressed into 1000, obtained FUGANNING PIAN.
Specific embodiments of the invention 3
Get Radix Angelicae Pubescentis 120g, Herba Lysimachiae 80g, Radix Isatidis 114g, Fructus Hordei Germinatus 45g, Radix Bupleuri 68g, Cortex Moutan 68g, be ground into 60 order coarse powder, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 30 DEG C, separator pressure 20Mpa, 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 fructose 100g, 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 40g, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, micropowder silica gel 20g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional leucine 8g, granulate, is pressed into 1000, obtained FUGANNING PIAN.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make FUGANNING PIAN.Actual effect of the present invention is investigated below with the FUGANNING PIAN that embodiment 3 is obtained:
(1) embodiment 3 FUGANNING PIAN and commercially available FUGANNING PIAN contrast disintegration
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 FUGANNING PIAN and commercially available FUGANNING PIAN contrast table disintegration
The above results shows, FUGANNING PIAN prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available FUGANNING PIAN.
(2) embodiment 3 FUGANNING PIAN and commercially available FUGANNING PIAN treat hepatitis B Disease Clinical observation of curative effect
1 case scenario
Statistics outpatient service and inpatient, observe hepatitis B disease case 110 example, 45 years old mean age altogether.Patient is divided into two groups, test group takes embodiment 3 FUGANNING PIAN, and matched group takes commercially available FUGANNING PIAN.
2 efficacy assessment standards
According to new Chinese medicine 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 FUGANNING PIAN and commercially available FUGANNING PIAN clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, FUGANNING PIAN prepared by the present invention is evident in efficacy higher than commercially available FUGANNING PIAN when treating hepatitis B disease, p < 0.05.

Claims (3)

1. treat a Chinese medicine for hepatitis B disease, it is characterized in that getting Radix Angelicae Pubescentis 120g, Herba Lysimachiae 80g, Radix Isatidis 114g, Fructus Hordei Germinatus 45g, Radix Bupleuri 68g, Cortex Moutan 68g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add fructose 80 ~ 120g, 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 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, suppresses to obtain FUGANNING PIAN.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Radix Angelicae Pubescentis 120g, Herba Lysimachiae 80g, Radix Isatidis 114g, Fructus Hordei Germinatus 45g, Radix Bupleuri 68g, Cortex Moutan 68g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add fructose 80 ~ 120g, 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 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, suppresses to obtain FUGANNING PIAN.
3. the preparation method of Chinese medicine according to claim 1, gets Radix Angelicae Pubescentis 120g, Herba Lysimachiae 80g, Radix Isatidis 114g, Fructus Hordei Germinatus 45g, Radix Bupleuri 68g, Cortex Moutan 68g, is ground into 60 order coarse powder, is ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 30Mpa, extraction temperature 30 DEG C, separator pressure 20Mpa, 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 fructose 100g, 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 40g, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, micropowder silica gel 20g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional leucine 8g, granulate, suppresses to obtain FUGANNING PIAN.
CN201410702359.3A 2014-11-29 2014-11-29 Fuganning tablet and preparation method thereof Withdrawn CN104474384A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106215037A (en) * 2016-07-30 2016-12-14 林启东 A kind of Fructus Hordei Germinatus scented tea for treating chronic hepatitis

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106215037A (en) * 2016-07-30 2016-12-14 林启东 A kind of Fructus Hordei Germinatus scented tea for treating chronic hepatitis

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Application publication date: 20150401