CN106109573A - A kind of compound isatis root granules and production technology thereof - Google Patents

A kind of compound isatis root granules and production technology thereof Download PDF

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Publication number
CN106109573A
CN106109573A CN201610436349.9A CN201610436349A CN106109573A CN 106109573 A CN106109573 A CN 106109573A CN 201610436349 A CN201610436349 A CN 201610436349A CN 106109573 A CN106109573 A CN 106109573A
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isatis root
root granules
compound isatis
parts
radix
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李国军
李�浩
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GUANGDONG HEPING JUNLE PHARMACEUTICAL CO Ltd
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GUANGDONG HEPING JUNLE PHARMACEUTICAL CO Ltd
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/19—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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/282—Artemisia, e.g. wormwood or sagebrush
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/288—Taraxacum (dandelion)
    • 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
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • 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
    • A61K36/539—Scutellaria (skullcap)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704—Polygonum, e.g. knotweed
    • 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)
    • A61K36/85—Verbenaceae (Verbena family)
    • A61K36/855—Clerodendrum, e.g. glorybower
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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    • 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
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
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    • 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
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • 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
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • 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
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps

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Abstract

The invention discloses a kind of compound isatis root granules and production technology thereof, including following components Radix Isatidis, Folium Isatidis, Herba Taraxaci, Radix Scutellariae, Radix Glycyrrhizae, Herba Artemisiae Scopariae, through decoctions, protease hydrolyzed, ethanol extraction, concentrate, compound isatis root granules that the manufacture of the technique such as granulation is new, it is an advantage of the current invention that: because with the addition of Radix Scutellariae, Herba Taraxaci, Radix Glycyrrhizae, Herba Artemisiae Scopariae define a kind of efficient compound isatis root granules product, there is anti-inflammation, improve immunity, it is possible to suppression lipid peroxide (LPO) also removes the several functions effects such as free radical.

Description

A kind of compound isatis root granules and production technology thereof
Technical field
The present invention relates to a kind of Radix Isatidis granule, particularly relate to a kind of energy heat-clearing and toxic substances removing, the compound recipe Baphicacanthus cusia of raising immunity Root granule.
Background technology
Radix Isatidis granule is conventional Chinese medicine preparation during people live, and there is a lot of functional component the inside.Existing a lot of to tradition The production technology that preparation technology improves, but it is all generally to retain more functional component only for pursuing or consider to produce The reason of equipment investment cost and technique dare not be had too many change.
Chinese invention patent publication No. is " CN104814988A ", entitled " preparation method of a kind of Radix Isatidis granule ", note The technical characteristic carried is as follows: soak Radix Isatidis, secondary decocts and filters, merging filtrate carries out concentrating again, spray granulation is dried.
Above-mentioned technique has certain effect, but owing to Radix Isatidis itself is containing fat-soluble macromole such as protein, decocts Rear filtration, protein, peptide molecule in filtrate can not completely remove, and make product impurity content high, it addition, this compound recipe Baphicacanthus cusia The functional component of root is the most single, and the mechanism of action is single, is unfavorable for that health makes an overall screening the harmful substance causing disease.
Summary of the invention
It is an object of the invention to provide a kind of compound isatis root granules and production technology thereof.
The present invention adopts the following technical scheme that in order to achieve the above object
A kind of compound isatis root granules, includes following component by weight:
Preferably, described Radix Isatidis is preferably 60 parts；Described Folium Isatidis is preferably 90 parts；Described Herba Taraxaci is preferably 4 parts； Described Radix Scutellariae is preferably 10 parts；Described Radix Glycyrrhizae is preferably 8 parts；Described Herba Artemisiae Scopariae is preferably 12 parts；Described cane sugar powder is preferably 140 Part.
A kind of compound isatis root granules preparation method, comprises the steps:
(1) weigh Radix Isatidis, Folium Isatidis, Radix Scutellariae, Radix Glycyrrhizae, Herba Artemisiae Scopariae boiling 2 times, each 1h by weight, merge filter Liquid；
(2) filtrate obtained toward step (1) adds protease, the protein in hydrolysis filtrate；
(3) filtrate after hydrolysis in step (2) is carried out membrance separation operation, reclaim and separate liquid；
(4) the separation liquid that step (3) obtained concentrates, and then adds the 85% of triplication or the alcohol reflux of 95% 2 times, each 1h；
(5) weigh Herba Taraxaci, be 85% or 95% alcohol reflux 2 times by volume fraction, each 2h, merge 2 Pus Herba Taraxaci extracting solution；
(6) the extracting solution mixing that extracting solution step (4) obtained and step (5) obtain, stands 24h, filters；
(7) filtrate of step (6) gained is concentrated into paste；
(8) starch is put in turnover barrel, add 1～1.5 times of cold purified water make it be suspended in water, pour boiling further according to concentration Water, stirring while adding, make 10% corn starch liquid；
(9) 10% corn starch liquid that cane sugar powder and step (8) are prepared slowly is poured in trough-type mixture machine, mixes about 5 Minute to uniformly, the thick paste adding step (7) gained makes soft material；
(10) soft material oscillating granulator is crossed 14 mesh sieves to pelletize；
(11) granule made is put in ebullated dryer；
(12) proceed to after particle drying in vibrating screen classifier, collect the granule between 10 mesh to 18 mesh and enter packaging link, Remaining is thick, fine grained is again pelletized, sieved.
Preferably, the protease in described step (2) can be pepsin, trypsin, and enzymolysis environment is 40 DEG C-50 DEG C, pH value is 7-8, enzymolysis 1-4h.
Preferably, described step (4) and the volume fraction of ethanol used by (5) are 85%.
Preferably, the addition of starch calculates as follows:
Corn starch=[100-runny plaste * (1-runny plaste moisture %)-cane sugar powder amount]/(1-starch moisture %).
Preferably, in described step (11), airpillow-dry environment is 80 DEG C.
Preferably, described step (11) is less than 0.8% particle drying to moisture.
It is an advantage of the current invention that: 1, Radix Isatidis, Folium Isatidis can be extracted respectively by decoction and ethanol extraction two ways Chinese herbal medicine water soluble ingredient and the liposoluble constituents such as leaf；
2, can come in enzymolysis Chinese herbal medicine by adding protease before the Chinese herbal medicine such as ethanol extraction Radix Isatidis, Folium Isatidis Fat-soluble protein macromolecule, more can remove impurity, improve Chinese herbal medicine effective ingredients concentration；
3, by increasing Herba Taraxaci, Radix Scutellariae, Radix Glycyrrhizae, Herba Artemisiae Scopariae Chinese herbal medicine on the basis of conventional formulation Radix Isatidis and Folium Isatidis Make compound isatis root granules, adapt to epidemic febrile disease heating, go out that speckle, anemopyretic cold, swelling throat be rotten, epidemic encephalitis type B, hepatitis, the cheek Adenitis symptom, has the effects such as heat-clearing and toxic substances removing, removing heat from blood, antibacterial, antiviral, raising immunity.
Detailed description of the invention
To describe the present invention in detail with specific embodiment below, at this, illustrative examples and explanation with the present invention are used Explain the present invention, but not as a limitation of the invention.
According to the proportioning of table 1 below, prepare compound isatis root granules
Table 1
Weigh each component by each embodiment of form 1, carry out following steps respectively:
(1) Radix Isatidis, Folium Isatidis, Radix Scutellariae, Radix Glycyrrhizae, Herba Artemisiae Scopariae boiling 2 times, each 1h, merging filtrate；
(2) filtrate obtained toward step (1) adds pepsin or trypsin, the protein in hydrolysis filtrate；
(3) filtrate after hydrolysis in step (2) is carried out membrance separation operation, reclaim and separate liquid；
(4) the separation liquid that step (3) obtained concentrates, then add triplication 85% alcohol reflux 2 times, often Secondary 1h；
(5) weigh Herba Taraxaci, be 85% alcohol reflux 2 times by volume fraction, each 2h, merge 2 Herba Taraxacis and carry Take liquid；
(6) the extracting solution mixing that extracting solution step (4) obtained and step (5) obtain, stands 24h, filters；
(7) filtrate of step (6) gained is concentrated into paste, i.e. runny plaste；
(8) starch is put in turnover barrel, add 1～1.5 times of cold purified water make it be suspended in water, pour boiling further according to concentration Water, stirring while adding, make 10% corn starch liquid；
(9) 10% corn starch liquid that cane sugar powder and step (8) are prepared slowly is poured in trough-type mixture machine, mixes about 5 Minute to uniformly, the thick paste adding step (7) gained makes soft material；
(10) soft material i.e. runny plaste oscillating granulator is crossed 14 mesh sieves to pelletize；
(11) granule made is put in ebullated dryer；
(12) proceed to after particle drying in vibrating screen classifier, collect the granule between 10 mesh to 18 mesh and enter packaging link, Remaining is thick, fine grained is again pelletized, sieved.
Wherein the addition of corn starch calculates as follows:
Corn starch=[100-runny plaste * (1-runny plaste moisture %)-cane sugar powder amount]/(1-starch moisture %).
Finished product of the present invention is shaped as the granule of brown, taste hardship sweet, micro-.
This technique produces with reference to " Good Manufacturing Practice and Quality Control of Drug (revision in 2010) ", " Traditional Chinese medicine historical preparation " the 12nd Volume WS3-B-2377-97, " compound isatis root granules technique verifies report (F) again " (R9-4042-01) are carried out.
Because Radix Isatidis and Folium Isatidis are conventional formulation, there is effect of traditional Radix Isatidis granule, do not repeat, and this Bright because with the addition of Radix Scutellariae, Herba Taraxaci, Radix Glycyrrhizae, Herba Artemisiae Scopariae define a kind of efficient compound isatis root granules product, have antibacterial disappearing Scorching, raising immunity, it is possible to suppression lipid peroxide (LPO) also removes the several functions effects such as free radical.
The technical scheme provided the embodiment of the present invention above is described in detail, specific case used herein Principle and embodiment to the embodiment of the present invention are set forth, and the explanation of above example is only applicable to help to understand this The principle of inventive embodiments；Simultaneously for one of ordinary skill in the art, according to the embodiment of the present invention, in specific embodiment party All will change in formula and range of application, in sum, this specification content should not be construed as limitation of the present invention.

Claims (8)

1. a compound isatis root granules, it is characterised in that: include following component by weight:
Compound isatis root granules the most according to claim 1, it is characterised in that:
Described Radix Isatidis is preferably 60 parts；
Described Folium Isatidis is preferably 90 parts；
Described Herba Taraxaci is preferably 4 parts；
Described Radix Scutellariae is preferably 10 parts；
Described Radix Glycyrrhizae is preferably 8 parts；
Described Herba Artemisiae Scopariae is preferably 12 parts；
Described cane sugar powder is preferably 140 parts.
3. a compound isatis root granules preparation method, it is characterised in that:
Comprise the steps:
(1) Radix Isatidis, Folium Isatidis, Radix Scutellariae, Radix Glycyrrhizae, Herba Artemisiae Scopariae boiling 2 times, each 1h, merging filtrate are weighed by weight；
(2) filtrate obtained toward step (1) adds protease, the protein in hydrolysis filtrate；
(3) filtrate after hydrolysis in step (2) is carried out membrance separation operation, reclaim and separate liquid；
(4) the separation liquid that step (3) obtained concentrates, then add triplication 85% or 95% alcohol reflux 2 times, 1h every time；
(5) weigh Herba Taraxaci, be 85% or 95% alcohol reflux 2 times by volume fraction, each 2h, merge 2 Herba Taraxacis Extracting solution；
(6) the extracting solution mixing that extracting solution step (4) obtained and step (5) obtain, stands 24h, filters；
(7) filtrate of step (6) gained is concentrated into paste；
(8) starch is put in turnover barrel, adds 1～1.5 times of cold purified water make it be suspended in water, pour boiling water further according to concentration, Stirring while adding, make 10% corn starch liquid；
(9) 10% corn starch liquid that cane sugar powder and step (8) are prepared slowly is poured in trough-type mixture machine, mixes about 5 minutes To uniformly, the thick paste adding step (7) gained makes soft material；
(10) soft material oscillating granulator is crossed 14 mesh sieves to pelletize；
(11) granule made is put in ebullated dryer；
(12) proceed to after particle drying in vibrating screen classifier, collect the granule between 10 mesh to 18 mesh and enter packaging link, remaining Slightly, fine grained is again pelletized, is sieved.
Compound isatis root granules preparation method the most according to claim 3, it is characterised in that:
Protease in described step (2) can be pepsin, trypsin, and enzymolysis environment is 40 DEG C-50 DEG C, and pH value is 7-8, Enzymolysis 1-4h.
Compound isatis root granules preparation method the most according to claim 1, it is characterised in that:
Volume fraction of ethanol used by described step (4) and (5) is 85%.
Compound isatis root granules preparation method the most according to claim 1, it is characterised in that:
The addition of starch calculates as follows:
Corn starch=[100-runny plaste * (1-runny plaste moisture %)-cane sugar powder amount]/(1-starch moisture %).
Compound isatis root granules preparation method the most according to claim 5, it is characterised in that:
In described step (11), airpillow-dry environment is 80 DEG C.
Compound isatis root granules preparation method the most according to claim 5, it is characterised in that:
Described step (11) is less than 0.8% particle drying to moisture.
CN201610436349.9A 2016-06-17 2016-06-17 A kind of compound isatis root granules and production technology thereof Pending CN106109573A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107854502A (en) * 2017-12-25 2018-03-30 安徽永生堂药业有限责任公司 A kind of production technology of Banlangen Granule
CN108969604A (en) * 2018-08-15 2018-12-11 康美保宁（四川）制药有限公司 A kind of pre-treating method and preparation method of compound isatis root granules
CN113230305A (en) * 2021-03-29 2021-08-10 广东和平君乐药业有限公司 Isatis root granules and preparation method thereof

Citations (3)

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Publication number Priority date Publication date Assignee Title
CN102908462A (en) * 2012-11-22 2013-02-06 广东和平君乐药业有限公司 Isatis root particle and preparation method thereof
CN104983691A (en) * 2015-06-28 2015-10-21 赵明亮 Preparation method and application of compound indigowoad root granules
CN105412347A (en) * 2015-12-04 2016-03-23 广东和平君乐药业有限公司 Radix isatidis particle and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102908462A (en) * 2012-11-22 2013-02-06 广东和平君乐药业有限公司 Isatis root particle and preparation method thereof
CN104983691A (en) * 2015-06-28 2015-10-21 赵明亮 Preparation method and application of compound indigowoad root granules
CN105412347A (en) * 2015-12-04 2016-03-23 广东和平君乐药业有限公司 Radix isatidis particle and preparation method thereof

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107854502A (en) * 2017-12-25 2018-03-30 安徽永生堂药业有限责任公司 A kind of production technology of Banlangen Granule
CN108969604A (en) * 2018-08-15 2018-12-11 康美保宁（四川）制药有限公司 A kind of pre-treating method and preparation method of compound isatis root granules
CN113230305A (en) * 2021-03-29 2021-08-10 广东和平君乐药业有限公司 Isatis root granules and preparation method thereof

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