CN108853363A - A kind of preparation method of high-quality gastrodia capsule - Google Patents
A kind of preparation method of high-quality gastrodia capsule Download PDFInfo
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- CN108853363A CN108853363A CN201811000349.XA CN201811000349A CN108853363A CN 108853363 A CN108853363 A CN 108853363A CN 201811000349 A CN201811000349 A CN 201811000349A CN 108853363 A CN108853363 A CN 108853363A
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
- A61K36/8988—Gastrodia
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- 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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- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
The invention discloses a kind of preparation methods of high-quality gastrodia capsule,In particular to one kind is by passing through water extracting mode effective component extracting for Rhizoma Gastrodiae,Due to effective component Gastrodin in Rhizoma Gastrodiae,Solubility is big in water for the substances such as polysaccharide,Therefore it can sufficiently extract the effective component of Rhizoma Gastrodiae,Acrylic resin is added during the extraction process,Using its polyhydroxy structure in conjunction with Rhizoma Gastrodiae effective component,Improve the fat-soluble of Rhizoma Gastrodiae effective component,Increase and absorbs,Again by will be after Rhizoma Gastrodiae extract drying and crushing,It is pelletized using the lactic acid ethanol solution of certain concentration,Novel polymer is combined into using the characteristic and acrylic resin of lactic acid,Wrap up Rhizoma Gastrodiae dried cream powder,Reduce its hygroscopicity,Improve product stability,Therefore it is good to obtain a kind of stability through the invention,Dissolution is fast,The gastrodia capsule of good absorbing,Under severe conditions,Significant changes will not occur for the dissolution rate of gastrodia capsule,Stability is preferable.
Description
Technical field
The present invention relates to a kind of preparation methods of high-quality gastrodia capsule, belong to the field of Chinese medicines.
Background technique
Rhizoma Gastrodiae, Chinese medicine name.This product is the rhizome of orchid Rhizoma Gastrodiae.Winter, the excavation of two season of spring, the winter person's of adopting name winter fiber crops, matter
It measures excellent;The spring person's of adopting name spring fiber crops, quality are good not as good as winter fiber crops.After digging out, the aerial stem of plant and fibrous root are removed, soil is cleaned, is steeped with clear water,
Rough bark is wiped in time, clear water is put into immediately or alum water impregnates, then boiling or steaming are thoroughly, until being degree when center is without white point, taking-up is dried in the air
It is dry, it dries or dries.Major function is:Relieve the wind syndrome, arresting convulsion.Control dizziness pupil, cold and headache, extremity numbness, hemiplegia, language
It is not smoothgoing puckery, infantile epilepsy and convulsions.
Modern pharmacy research shows that its effective component be Gastrodin, vanillic aldehyde, parahydroxyben-zaldehyde, polysaccharide etc. it is a variety of at
Point, have the effects that calm, analgesia, anticonvulsion, anti-inflammatory, improvement memory and delays senescence.During modern clinic in Rhizoma Gastrodiae
Patent medicine preparation is by extensively in treatment rheumatic joint disease, dizziness, headache, neural pain etc., the current domestic preparation to Rhizoma Gastrodiae
Study a lot of, but most of is that Rhizoma Gastrodiae is mixed combination with other Chinese medicines, is prepared into corresponding prescribed preparation, Rhizoma Gastrodiae
Drug effect is significant, and pharmacological research clearly certainly will generate other with the combination of other medicinal materials and react, and has for the pharmacology of itself certain
Influence, however less for the single formulation research of Rhizoma Gastrodiae at present, it is high to be primarily due to water soluble ingredient content in Rhizoma Gastrodiae, system
The standby extract moisture absorption out is serious, influences product quality, and exploitation single preparations of ephedrine difficulty is big, I is opened by years of researches
Issue a kind of Rhizoma Gastrodiae single preparations of ephedrine that quality is stable.
Summary of the invention
To solve the above-mentioned problems of the prior art, the present invention provides a kind of preparation method of gastrodia capsule, the present invention
Resulting gastrodia capsule preparation method is simple controllably, is suitable for industrialization production, and stability is good, significant in efficacy, on realizing
Invention is stated, embodiment is as follows:
One, it takes Processed Product of Rhizoma Gastrodiae appropriate, acrylic resin is added and is equivalent to the water that 2-4 times of Rhizoma Gastrodiae quality is measured, it is small to be heated to reflux 2-4
When, filtering is extracted 1-3 times, merging filtrate, and it is 1.1-1.2 that filtrate, which is concentrated into relative density,(50-60 DEG C of detection)Stiff paste, do
It is dry at dry cream, crushed 80 meshes;Carry out during heating and refluxing extraction it is intermittent vacuumize and vacuum breaker, utilize pressure
Difference variation promotes mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component;Ultrasonic vibration is carried out during heating and refluxing extraction, is utilized
The cavitation effect of ultrasonic wave promotes mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component.
Preferably, the Processed Product of Rhizoma Gastrodiae meets《Chinese Pharmacopoeia》2015 editions one regulation.
Preferably, the acrylic resin additional amount is the 0.5%-1.5% of Rhizoma Gastrodiae quality.
Two, Rhizoma Gastrodiae dried cream powder is mixed with diluent, lactic acid ethanol solution is added, granulation, after dry, whole grain pours into glue
Capsule.
Preferably, the diluent is made of starch, acrylic resin and microcrystalline cellulose;Forming mass ratio is 1:
0.5:1。
Preferably, the acrylic resin and Rhizoma Gastrodiae dried cream powder mass ratio are 1:20-40.
Preferably, the lactic acid ethanol solution is made of lactic acid, ethyl alcohol, water, composition ratio 2:60:38.
Preferably, the granulation refers to is pelletized using the stainless steel mesh of certain mesh number, and the drying includes
Hot air circulation drying and fluidized drying;The whole grain refers to the stainless steel mesh by the particle after drying by certain mesh number,
Carry out whole grain.
Further, the granulation sieve mesh number is 16-24 mesh, and whole grain sieve mesh number is 16-24 mesh.
The method have the characteristics that:
The present invention is dried to obtain Rhizoma Gastrodiae dried cream powder, acrylic acid is added during boiling by the way that Processed Product of Rhizoma Gastrodiae is carried out boiling extraction
Resin, containing great amount of hydroxy group, in conjunction with the effective components such as Gastrodin, polysaccharide, Gastrodine, being formed has certain fat-soluble polymerization
Object reduces the hygroscopicity of medicinal extract, increases its assimilation effect.
For the present invention also by the way that Rhizoma Gastrodiae dried cream powder is pelletized by lactic acid ethanol solution, lactic acid has certain acid, reduction third
Olefin(e) acid resin dissolves in water, and lactic acid is a kind of carboxylic acid of small molecule, after self-polymerization, forms long-chain molecule and acrylic acid tree
Rouge combines, and formation is not easy penetrating polymer, and pelletization is preferably wrapped up the water soluble ingredient in Rhizoma Gastrodiae, into one
Step reduces its moisture absorption, improves its stability.
The beneficial effects of the present invention are:
1, the present invention obtains a kind of gastrodia capsule that quality is stable.
2, the gastrodia capsule good absorbing that the present invention obtains, it is significant in efficacy.
Preparation method of the present invention is simple, and raw material are easy to get, and is suitable for industrialization, large-scale production.
Specific embodiment
Main points in order to better understand the present invention are now described in further detail foregoing invention by specific embodiment, but under
Stating embodiment should not be understood as to further limitation of the invention.
Following embodiment batches are 2000.
Embodiment 1
1, Processed Product of Rhizoma Gastrodiae 10kg as defined in meeting is taken, acrylic resin is added and is equivalent to the water of 3 times of Rhizoma Gastrodiae quality amounts, acrylic acid
Resin amount is the 1.0% of Rhizoma Gastrodiae quality, is heated to reflux 3 hours, is filtered, and is extracted 2 times, merging filtrate, filtrate is concentrated into relatively
Density is 1.15(50-60 DEG C of detection)Stiff paste, be dried to dry cream, crushed 80 meshes;During heating and refluxing extraction
Carry out it is intermittent vacuumize and vacuum breaker, utilize pressure difference variation to promote mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component;Add
Ultrasonic vibration is carried out during circumfluence distillation, promotes mass transfer using the cavitation effect of ultrasonic wave and more thoroughly dissolution Rhizoma Gastrodiae has
Imitate ingredient.
2, Rhizoma Gastrodiae dried cream powder is mixed with diluent, the diluent is by starch, acrylic resin and microcrystalline cellulose
Composition;Forming mass ratio is 1:0.5:1;The acrylic resin and Rhizoma Gastrodiae dried cream powder mass ratio is 1:30.Cream is added
Sour ethanol solution, the lactic acid ethanol solution are made of lactic acid, ethyl alcohol, water, composition ratio 2:60:38;Granulation, it is dry
Afterwards, whole grain pours into capsule.
Embodiment 2
1, Processed Product of Rhizoma Gastrodiae 10kg as defined in meeting is taken, acrylic resin is added and is equivalent to the water of 2 times of Rhizoma Gastrodiae quality amounts, acrylic acid
Resin amount is the 0.5% of Rhizoma Gastrodiae quality, is heated to reflux 2 hours, is filtered, and is extracted 1 time, merging filtrate, filtrate is concentrated into relatively
Density is 1.1(50-60 DEG C of detection)Stiff paste, be dried to dry cream, crushed 80 meshes;During heating and refluxing extraction into
Row is intermittent to be vacuumized and vacuum breaker, and pressure difference variation is utilized to promote mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component;Heating
Ultrasonic vibration is carried out during refluxing extraction, promotes mass transfer using the cavitation effect of ultrasonic wave and more thoroughly dissolution Rhizoma Gastrodiae is effective
Ingredient.
2, Rhizoma Gastrodiae dried cream powder is mixed with diluent, the diluent is by starch, acrylic resin and microcrystalline cellulose
Composition;Forming mass ratio is 1:0.5:1;The acrylic resin and Rhizoma Gastrodiae dried cream powder mass ratio is 1:20.Cream is added
Sour ethanol solution, the lactic acid ethanol solution are made of lactic acid, ethyl alcohol, water, composition ratio 2:60:38;Granulation, it is dry
Afterwards, whole grain pours into capsule.
Embodiment 3
1, Processed Product of Rhizoma Gastrodiae 10kg as defined in meeting is taken, acrylic resin is added and is equivalent to the water of 4 times of Rhizoma Gastrodiae quality amounts, acrylic acid
Resin amount is the 1.5% of Rhizoma Gastrodiae quality, is heated to reflux 4 hours, is filtered, and is extracted 3 times, merging filtrate, filtrate is concentrated into relatively
Density is 1.2(50-60 DEG C of detection)Stiff paste, be dried to dry cream, crushed 80 meshes;During heating and refluxing extraction into
Row is intermittent to be vacuumized and vacuum breaker, and pressure difference variation is utilized to promote mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component;Heating
Ultrasonic vibration is carried out during refluxing extraction, promotes mass transfer using the cavitation effect of ultrasonic wave and more thoroughly dissolution Rhizoma Gastrodiae is effective
Ingredient.
2, Rhizoma Gastrodiae dried cream powder is mixed with diluent, the diluent is by starch, acrylic resin and microcrystalline cellulose
Composition;Forming mass ratio is 1:0.5:1;The acrylic resin and Rhizoma Gastrodiae dried cream powder mass ratio is 1:40.Cream is added
Sour ethanol solution, the lactic acid ethanol solution are made of lactic acid, ethyl alcohol, water, composition ratio 2:60:38;Granulation, it is dry
Afterwards, whole grain pours into capsule.
Comparative example 1
1, Processed Product of Rhizoma Gastrodiae 10kg as defined in meeting is taken, the water for being equivalent to 3 times of Rhizoma Gastrodiae quality amounts is added, is heated to reflux 3 hours, mistake
Filter is extracted 2 times, merging filtrate, and it is 1.15 that filtrate, which is concentrated into relative density,(50-60 DEG C of detection)Stiff paste, be dried to dry cream, powder
Broken 80 mesh of mistake;Carry out during heating and refluxing extraction it is intermittent vacuumize and vacuum breaker, utilize pressure difference variation to promote
Mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component;Ultrasonic vibration is carried out during heating and refluxing extraction, utilizes the sky of ultrasonic wave
Change effect and promotes mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component.
2, Rhizoma Gastrodiae dried cream powder is mixed with diluent, the diluent is by starch, acrylic resin and microcrystalline cellulose
Composition;Forming mass ratio is 1:0.5:1;The acrylic resin and Rhizoma Gastrodiae dried cream powder mass ratio is 1:30.Second is added
Alcoholic solution, the ethanol solution are made of ethyl alcohol, water, composition ratio 60:40;Granulation, after dry, whole grain pours into capsule
?.
Comparative example 2
1, Processed Product of Rhizoma Gastrodiae 10kg as defined in meeting is taken, the water for being equivalent to 2 times of Rhizoma Gastrodiae quality amounts is added, is heated to reflux 2 hours, mistake
Filter is extracted 1 time, merging filtrate, and it is 1.1 that filtrate, which is concentrated into relative density,(50-60 DEG C of detection)Stiff paste, be dried to dry cream, powder
Broken 80 mesh of mistake;Carry out during heating and refluxing extraction it is intermittent vacuumize and vacuum breaker, utilize pressure difference variation to promote
Mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component;Ultrasonic vibration is carried out during heating and refluxing extraction, utilizes the sky of ultrasonic wave
Change effect and promotes mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component.
2, Rhizoma Gastrodiae dried cream powder is mixed with diluent, the diluent is by starch, acrylic resin and microcrystalline cellulose
Composition;Forming mass ratio is 1:0.5:1;The acrylic resin and Rhizoma Gastrodiae dried cream powder mass ratio is 1:20.Second is added
Alcoholic solution, the ethanol solution are made of ethyl alcohol, water, composition ratio 60:40;Granulation, after dry, whole grain pours into capsule
?.
Comparative example 3
1, Processed Product of Rhizoma Gastrodiae 10kg as defined in meeting is taken, the water for being equivalent to 4 times of Rhizoma Gastrodiae quality amounts is added, is heated to reflux 4 hours, mistake
Filter is extracted 3 times, merging filtrate, and it is 1.2 that filtrate, which is concentrated into relative density,(50-60 DEG C of detection)Stiff paste, be dried to dry cream, powder
Broken 80 mesh of mistake;Carry out during heating and refluxing extraction it is intermittent vacuumize and vacuum breaker, utilize pressure difference variation to promote
Mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component;Ultrasonic vibration is carried out during heating and refluxing extraction, utilizes the sky of ultrasonic wave
Change effect and promotes mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component.
2, Rhizoma Gastrodiae dried cream powder is mixed with diluent, the diluent is by starch, acrylic resin and microcrystalline cellulose
Composition;Forming mass ratio is 1:0.5:1;The acrylic resin and Rhizoma Gastrodiae dried cream powder mass ratio is 1:40.Second is added
Alcoholic solution, the lactic acid ethanol solution are made of ethyl alcohol, water, composition ratio 60:40;Granulation, after dry, whole grain is poured into
Capsule.
Preparation process evaluation
Carry out preparing gastrodia capsule according to embodiment 1-3 and comparative example 1-3 respectively, according to the complexity of preparation process into
Row evaluation, record-keeping system are recorded a demerit as follows for phenomenon:
Embodiment | Prepare phenomenon | Particle yield |
Embodiment 1 | Preparation process is smooth, prepares that softwood controllability is strong, and mobility of particle is good, and hygroscopicity is preferably controlled, it is filling smoothly | 98.8% |
Embodiment 2 | Preparation process is smooth, prepares that softwood controllability is strong, and mobility of particle is good, and hygroscopicity is preferably controlled, it is filling smoothly | 97.8% |
Embodiment 3 | Preparation process is smooth, prepares that softwood controllability is strong, and mobility of particle is good, and hygroscopicity is preferably controlled, it is filling smoothly | 98.5% |
Comparative example 1 | Softwood is difficult to control, and the particle moisture absorption is serious, and filling is difficult, and content uniformity is larger, and midway needs constantly cleaning mold. | 78.8% |
Comparative example 2 | Softwood is difficult to control, and the particle moisture absorption is serious, and filling is difficult, and content uniformity is larger, and midway needs constantly cleaning mold. | 82.3% |
Comparative example 3 | Softwood is difficult to control, and the particle moisture absorption is serious, and filling is difficult, and content uniformity is larger, and midway needs constantly cleaning mold. | 69.7% |
It analyzes from the above, the Rhizoma Gastrodiae particle that the present invention obtains is suitable for filling, and preparation process controllability is strong.
Study on the stability
Example 1-3 and each 50g of the resulting gastrodia capsule of comparative example 1-3, is respectively put into 10 low density polyethylene (LDPE) bottles
In, each bottled gastrodia capsule 5g of low density polyethylene (LDPE) covers tightly bottle cap, heat-sealing, by above-mentioned low density polyethylene bottle be put into 40 DEG C,
Under 75% damp condition, moisture and dissolution rate are detected respectively.
1, water content detection
According to《Chinese Pharmacopoeia》Embodiment 1-3 is detected about the oven drying method in moisture detecting method in 2015 editions four and comparison is real
The pellet moisture of a 1-3 is applied, it is as a result as follows:
Date | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
0 month(%) | 0.62 | 0.54 | 0.71 | 0.68 | 0.72 | 0.73 |
January(%) | 0.68 | 0.81 | 0.72 | 2.56 | 2.86 | 2.77 |
2 months(%) | 0.75 | 0.82 | 0.83 | 7.86 | 7.01 | 7.99 |
March(%) | 0.92 | 0.96 | 0.92 | 11.5 | 10.36 | 11.18 |
April(%) | 1.05 | 1.08 | 1.04 | 13.52 | 12.99 | 13.08 |
May(%) | 1.09 | 1.19 | 1.15 | 14.05 | 14.09 | 14.98 |
June(%) | 1.22 | 1.24 | 1.38 | 14.69 | 15.02 | 15.78 |
It analyzes from the above, under severe conditions, moisture has no and rises appreciably gastrodia capsule of the invention within 6 months.
2. dissolution rate is investigated
The gastrodia capsule dissolution situation of 0 month, March, June, reference are detected respectively《Chinese Pharmacopoeia》2015 in version four about molten
Out-degree detection method takes gastrodia capsule 6, is put into stripping rotor, using water as dissolution medium, respectively 5min, 10min,
15min, 30min sample 5ml, reference《Chinese Pharmacopoeia》Version one middle Rhizoma Gastrodiae detection method in 2015, the content in test sample,
Solubility is calculated, the mean value of 6 dissolution rates is calculated, it is as a result as follows:
0 month testing result
Time | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
5min(%) | 75.5 | 78.6 | 79.5 | 60.7 | 62.8 | 55.9 |
10min(%) | 89.5 | 90.5 | 91.4 | 75.9 | 72.9 | 70.4 |
15min(%) | 94.8 | 96.2 | 96.8 | 84.5 | 86.5 | 81.5 |
30min(%) | 98.5 | 96.4 | 99.5 | 90.2 | 91.4 | 89.9 |
March testing result
Time | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
5min(%) | 72.5 | 76.8 | 71.5 | 32.5 | 30.4 | 28.9 |
10min(%) | 86.3 | 88.4 | 84.9 | 54.6 | 51.8 | 48.9 |
15min(%) | 95.6 | 94.8 | 96.4 | 60.4 | 59.6 | 57.2 |
30min(%) | 99.5 | 97.8 | 99.6 | 62.8 | 64.5 | 68.2 |
June testing result
Time | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
5min(%) | 69.8 | 65.9 | 75.8 | 10.5 | 9.5 | 11.4 |
10min(%) | 84.5 | 89.3 | 88.4 | 20.1 | 23.5 | 24.2 |
15min(%) | 94.5 | 93.6 | 92.8 | 30.2 | 29.8 | 26.5 |
30min(%) | 95.9 | 94.7 | 96.8 | 33.4 | 34.3 | 30.7 |
It analyzes from the above, the resulting gastrodia capsule dissolution rate of the present invention is very fast, and under severe conditions, dissolution speed
Degree has no significant change, and stability is preferable.
Claims (5)
1. a kind of preparation method of high-quality gastrodia capsule, it is characterised in that including following steps:
(1)It takes Processed Product of Rhizoma Gastrodiae appropriate, acrylic resin is added and is equivalent to the water that 2-4 times of Rhizoma Gastrodiae quality is measured, it is small to be heated to reflux 2-4
When, filtering is extracted 1-3 times, merging filtrate, and it is 1.1-1.2 that filtrate, which is concentrated into relative density,(50-60 DEG C of detection)Stiff paste, do
It is dry at dry cream, crushed 80 meshes;Carry out during heating and refluxing extraction it is intermittent vacuumize and vacuum breaker, utilize pressure
Difference variation promotes mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component;Ultrasonic vibration is carried out during heating and refluxing extraction, is utilized
The cavitation effect of ultrasonic wave promotes mass transfer and more thoroughly dissolution Rhizoma Gastrodiae effective component;
(2)Rhizoma Gastrodiae dried cream powder is mixed with diluent, lactic acid ethanol solution is added, granulation, after dry, whole grain pours into capsule i.e.
It can.
2. the preparation method of high-quality gastrodia capsule according to claim 1, it is characterised in that:The acrylic resin adds
Enter the 0.5%-1.5% that amount is Rhizoma Gastrodiae quality.
3. the preparation method of high-quality gastrodia capsule according to claim 1, it is characterised in that:The diluent is by forming sediment
Powder, acrylic resin and microcrystalline cellulose composition;Forming mass ratio is 1:0.5:1.
4. the preparation method of high-quality gastrodia capsule according to claim 3, it is characterised in that:The acrylic resin with
Rhizoma Gastrodiae dried cream powder mass ratio is 1:20-40.
5. the preparation method of high-quality gastrodia capsule according to claim 1, it is characterised in that:The lactic acid ethanol solution
It is made of lactic acid, ethyl alcohol, water, composition ratio 2:60:38.
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CN201811000349.XA CN108853363A (en) | 2018-08-30 | 2018-08-30 | A kind of preparation method of high-quality gastrodia capsule |
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CN201811000349.XA CN108853363A (en) | 2018-08-30 | 2018-08-30 | A kind of preparation method of high-quality gastrodia capsule |
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CN201811000349.XA Withdrawn CN108853363A (en) | 2018-08-30 | 2018-08-30 | A kind of preparation method of high-quality gastrodia capsule |
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Application publication date: 20181123 |