CN105997918A - Thin film coating agent for masking special smell - Google Patents
Thin film coating agent for masking special smell Download PDFInfo
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- CN105997918A CN105997918A CN201610390377.1A CN201610390377A CN105997918A CN 105997918 A CN105997918 A CN 105997918A CN 201610390377 A CN201610390377 A CN 201610390377A CN 105997918 A CN105997918 A CN 105997918A
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- coating agent
- film coating
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- polyethylene glycol
- polyvinyl alcohol
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- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to a thin film coating agent for masking a special smell. The thin film coating agent mainly comprises cellulose ether derivatives, polyvinyl alcohol, polyethylene glycol derivatives and MAE100P, and also can contain a colorant according to the needs; the thin film coating agent can form a tough and compact film on the surface of a drug to play a good obstructing effect on a drug peculiar smell; and the coating agent has better dampproof effect.
Description
Technical field:
The present invention relates to the coating material of a kind of medicine and field of food, special gas can be covered particularly to one
The film coating agent of taste.
Background technology:
It is irritating or make us that the effective ingredient itself having a lot of medicine in our daily life has some
Offending abnormal smells from the patient, affects taking of patient.The method improving adverse drug abnormal smells from the patient at present has: interpolation correctives,
Flavoring agent, encapsulated, to tablet or drug particles coating, spent ion exchange resin adsorbs, medicine is made bag
Compound, nanocapsule or odourless precursors medicine etc..It covers mechanism mainly has following several: the first by medicine with
Taste bud on oral mucosa separates；Its two be add correctives, flavoring agent to cover the taste of medicine；It three is
Taste bud is carried out temporary transient reversibility paralysis；Another is the structure of medicine to be transformed, and is prepared as without bitterness
Prodrug.
Most common method when coating method is to cover adverse drug abnormal smells from the patient, film-coated technique is exactly by film coating
Powder adds solvent, forms finely dispersed mixture, through spray film coating, form the plastic films that a few micrometers is thick,
The technical process being wrapped in machining object.Its operation principle is tablet when operating in seed-coating machine, by coating
Solution or the superfine little droplet jet of suspension to the appearance of the sheet heart, by contact, are sprawled and mutual between drop
In conjunction with, form one layer of clothing film on sheet heart surface, two kinds of effects occur between solvent and the sheet heart in this course,
The i.e. solvent osmosis to the sheet heart and the volatilization of solvent.When the evaporation capacity of solvent is constant, and spray with solvent
Enter amount equal time, the process of coating reach balance.
Being critical that with excellent film coating agent of film coating process.Superior in quality film coating agent should accord with
Closing operation pulping easily and fast, suspendible are uniformly, solvent simplifies, atomization is good, film forming is rapid, unilateral attractive in appearance,
Colour stable and the high requirement of moisture resistance.Especially those there is the preparation of bad smell, even if having employed thin film
Medicine is coated by packaging technique, such as the bag of the hydroxypropyl methyl cellulose of routine (HPMC) type
Clothing agent, but its clothing membrane porosity is big, and abnormal smells from the patient by hole out still can not play and well cover medicine
The effect of abnormal flavour.A kind of there is relatively low thin film permeability so developing, the new of adverse drug abnormal smells from the patient can be intercepted
Type film coating agent is necessary.
MAE100P (trade name: Kollicoat MAE 100P), for a kind of first thing base acrylic acid/propylene
Acetoacetic ester copolymerization, for the film former of enteric film-coated preparation, it belongs to the one of the big apoplexy due to endogenous wind of polyacrylic resin
Kind, major part polyacrylic resin is alcohol-soluble, and needing during use to add a large amount of ethanol is solvent, causes cost
Rise and environmental pollution；The main characteristic of MAE100P is to play good flavor barrier effect,
And this material is that acrylic monomers is polymerized by emulsion, then it is spray-dried and forms powder, during use, be not required to second
Alcohol dissolves, and only need to be added into being sufficiently stirred in water, so that it may by material dispersion in water, do not interfere with after coating
The dissolvent residual of medicine, also will not be to environment；And MAE100P powder can be made with other composition
For becoming powder body coating materials, the shelf-life, up to 2 years, can add pure water within the shelf-life at any time and dissolve use.
Summary of the invention
Film coating agent of the present invention, the composition of each component is as follows:
Preferred film coating agent of the present invention, the composition of each component is as follows:
The percentage ratio of the present invention is mass percent, wherein,
Described cellulose ether derivative be hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose,
A kind of or any two kinds or the most two or more combinations in methylcellulose, carboxymethyl cellulose.
Described polyethyleneglycol derivative be PEG400, polyethylene glycol 1500, PEG3350,
One in Macrogol 4000, polyethylene glycol 6000, PEG 8000 or any two kinds or any two kinds
Above combination.
Described coloring agent is the one in titanium dioxide, color lake, ferrum oxide or any two kinds or the most two or more
Combination.
The preparation method of film coating agent of the present invention is as follows:
Pulverize, with quantitative after sieving with pulverizer after quantitative coloring agent is mixed with basis weight of fiber element ether derivant
Acrylic resin derivant, polyvinyl alcohol, Polyethylene Glycol mix, and to color even, prepare coating materials.
Preferably, the preparation method of film coating agent of the present invention is as follows:
First basis weight of fiber element ether is put into three-dimensional mixer, then put into quantitative coloring agent, mix 20 minutes extremely
Uniformly.With Universalpulverizer, mixed material is pulverized, sieves, can be selected for 40 120 eye mesh screens,
Preferably 60 100 eye mesh screens.On-the-sieve material can put into pulverizer and continue to pulverize, by the material of screen cloth with quantitative
Acrylic resin derivant, polyvinyl alcohol, Polyethylene Glycol enter three-dimensional mixer and mix, incorporation time is
30 80 minutes, preferably incorporation time was 50 60 minutes.Mixing uniformity can be by measuring mixing apparatus
The material color distortion of different parts judges.Is respectively coated on flat board after the material dissolution that each position is taken,
The aberration (△ E) of each thin film is measured after drying and forming-film.When the △ E of mixer each position material is less than 2.0,
It is believed that mix homogeneously.
Film coating agent taste masking effect assessment of the present invention
1. evaluation methodology
The effect of coating materials isolation adverse drug abnormal smells from the patient is evaluated by the method for application double blinding.We take commercially available
Garlicin label is respectively adopted the film coating agent of reference examples film coating agent and the present invention and is coated, after coating
Medicine do not indicate prescription, only do numeral labelling and be placed in airtight plastic bag 6 hours, by 10 participations
The personnel of experiment open the abnormal smells from the patient that medicine distributes by bag mouth and judge.
Reference examples film coating agent is chosen and prepares explanation: Eudragit Ⅳ powder body is insoluble in water, in second
Alcohol dissolves, so the Eudragit Ⅳ aqueous emulsion that we use emulsion polymerization to obtain prepares coating materials.Will
The titanium dioxide of formula ratio, color lake mix with hydroxypropyl methyl cellulose after with pulverizer pulverize, after sieving with join
The polyvinyl alcohol of side's amount, Polyethylene Glycol mix, to color even.Said mixture material is slowly added into and stirs
To dissolving in the purified water mixed, uniformly mix prepared with Eudragit Ⅳ aqueous emulsion.
Reference examples film coating agent forms:
Film coating agent of the present invention forms:
2. evaluation result
The coated tablet that abnormal smells from the patient that 9 experimenters select is less is the coating materials coating using the present invention, to every
The effect approval rate of adverse drug abnormal smells from the patient absolutely reaches 90%, illustrates that the effect of coating materials obstruct abnormal flavour is preferable.Reference examples
The medicine of coating only 2 people think that its abnormal smells from the patient is less, illustrate use other type acrylic resin effect and fail to understand
Aobvious.
3. conclusion
Reference examples is the harm avoiding organic solvent, formula adds acrylic resin aqueous emulsion.Prepare coating
Need during liquid first by after the mixing completely of other composition again with aqueous emulsion mixed dissolution, relatively complicated；Stirring condition
Control bad to easily cause emulsion breaking, affect using effect, and need to use immediately after preparing, it is impossible to time long
Between preserve.And this patent uses MAE100P powder body and other composition can prepare powder body coating materials, the shelf-life
Up to 2 years, pure water can be added within the shelf-life at any time and dissolve use.
When drug administration, in coating materials clothing film involved in the present invention, water-soluble material is fast in water or Digestive system
Instant solution, promotes clothing film to dissolve within a short period of time, and moisture penetrates into inside medicine, does not interferes with the disintegrate of medicine
And release.
Visible film coating agent taste masking effect of the present invention is preferable.
Coating materials of the present invention is for the impact of medicine moisture resistance
1. moistureproof method of testing:
Identical model drug is wrapped by the film coating agent using the present invention with the film coating agent of reference examples
Clothing, thin membrane coated tablet is put into 40 DEG C, the climatic chamber of 75% humidity, is recorded the highest moisture absorption of medicine every day
Rate and cosmetic variation situation.
Prescription A:
Prescription B:
Embodiment 4:
Prescription C:
2. experimental result:
| Coated tablet prescription | Reference examples | The present invention | Prescription A | Prescription B | Prescription C |
| Moisture absorption ratio | 4.34% | 3.65% | 4.07% | 3.84% | 3.95% |
| Reach time to peak | 3rd day | 4th day | 3rd day | 4th day | 3rd day |
3. conclusion:
After measured, reference examples coated tablet reaches peak at the 3rd day moisture absorption ratio, is up to 4.34%, subsequently by
The most steadily it is declined slightly；And use the coated tablet of the present invention to reach peak at the 4th day moisture absorption ratio, it is up to
3.65%.Illustrate that the coating materials moisture-proof role of the present invention is better than reference examples coating materials, it is possible to decrease the moisture absorption ratio of medicine,
Slowing down moisture absorption speed, good effect is played in the preservation to medicine.
The beneficial effects of the present invention is:
MAE100P in film coating agent the most of the present invention, this material is that acrylic monomers is polymerized by emulsion, then sprays
Mist is dried formation powder, is not required to ethanol and dissolves, only need to be added into being sufficiently stirred in water, so that it may by thing during use
Material is dispersed in water, and does not interferes with the dissolvent residual of medicine after coating, also will not be to environment.
2.MAE100P is good with the conventional HPMC compatibility, can form the film of tough and tensile densification at medical surfaces, to medicine
Thing abnormal flavour plays good iris action；Also to make moisture to rest on thin for the hydrophobic group of acrylic resin simultaneously
Film surface, decreases the moisture penetrating into medicine, strengthens the moisture effect of coating materials.
Detailed description of the invention
Further illustrate the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1:
A kind of film coating agent completely cutting off adverse drug abnormal smells from the patient, the composition of each component is as follows:
The film coating agent preparation method of above-mentioned isolation adverse drug abnormal smells from the patient is: by the titanium dioxide of formula ratio, color
Form sediment after mix with hydroxypropyl methyl cellulose with pulverizer pulverizing, after sieving with the MAE100P of formula ratio, gather
Vinyl alcohol, Polyethylene Glycol mix, and to color even, prepare powder body coating materials.
Embodiment 2:
A kind of film coating agent completely cutting off adverse drug abnormal smells from the patient, the composition of each component is as follows:
The film coating agent preparation method of above-mentioned isolation adverse drug abnormal smells from the patient is by the titanium dioxide of formula ratio and first
Pulverize, with the MAE100P of formula ratio, polyvinyl alcohol, poly-second after sieving with pulverizer after the mixing of base cellulose
Glycol mixes, and to color even, prepares powder body coating materials.
Embodiment 3:
A kind of film coating agent completely cutting off adverse drug abnormal smells from the patient, the composition of each component is as follows:
The film coating agent preparation method of above-mentioned isolation adverse drug abnormal smells from the patient is that the hydroxypropyl methyl of formula ratio is fine
Dimension element, MAE100P, polyvinyl alcohol, Polyethylene Glycol mix, and to uniformly, prepare powder body coating materials.
The present embodiment does not use coloring agent, it is possible to form transparent clothing film, embody the original external appearance characteristic of product.
Embodiment 4:
A kind of film coating agent completely cutting off adverse drug abnormal smells from the patient, the composition of each component is as follows:
The film coating agent preparation method of above-mentioned isolation adverse drug abnormal smells from the patient is by the color lake of formula ratio and hydroxypropyl
Pulverize, with the MAE100P of formula ratio, polyvinyl alcohol, poly-second two after sieving with pulverizer after cellulose mixing
Alcohol mixes, and to color even, prepares powder body coating materials.
Embodiment 5:
A kind of film coating agent completely cutting off adverse drug abnormal smells from the patient, the composition of each component is as follows:
The film coating agent preparation method of above-mentioned isolation adverse drug abnormal smells from the patient is by the iron oxide red of formula ratio and carboxylic
Pulverize with pulverizer after methylcellulose mixing, with the MAE100P of formula ratio, polyvinyl alcohol, poly-after sieving
Ethylene glycol mixes, and to color even, prepares powder body coating materials.
Embodiment 6:
Preparation method is by the crushing material of formula ratio, mixing, to color even, prepares coating materials.
Embodiment 7:
Preparation method is by the crushing material of formula ratio, mixing, prepares coating materials.
Embodiment 8:
Preparation method is by the crushing material of formula ratio, mixing, to color even, prepares coating materials.
Embodiment 9:
Preparation method is by the crushing material of formula ratio, mixing, prepares coating materials.
Claims (10)
1. a film coating agent, it is characterised in that containing cellulose ether derivative, polyvinyl alcohol, Polyethylene Glycol
Derivant and MAE100P.
Film coating agent the most according to claim 1, it is characterised in that possibly together with coloring agent.
Film coating agent the most according to claim 2, it is characterised in that the mass percent composition of each component
As follows: cellulose ether derivative accounts for 30% 60%, polyvinyl alcohol accounts for 5% 25%, polyethyleneglycol derivative accounts for
5% 30%, MAE100P accounts for 10% 48%, coloring agent accounts for 0% 32%.
Film coating agent the most according to claim 3, it is characterised in that the mass percent composition of each component
As follows: cellulose ether derivative accounts for 40% 50%, polyvinyl alcohol accounts for 10% 17%, polyethyleneglycol derivative accounts for
10% 20%, MAE100P accounts for 22% 34%, coloring agent accounts for 10% 20%.
5. according to the film coating agent according to any one of claim 1-4, it is characterised in that described cellulose
Ether derivant is: hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, methylcellulose,
A kind of or any two kinds or the most two or more combinations in carboxymethyl cellulose.
6. according to the film coating agent according to any one of claim 1-4, it is characterised in that described poly-second two
01 derivatives is: PEG400, polyethylene glycol 1500, PEG3350, Macrogol 4000,
A kind of or any two kinds or the most two or more combinations in polyethylene glycol 6000, PEG 8000.
7. according to the film coating agent according to any one of claim 2-4, it is characterised in that described coloring agent
For: a kind of or any two kinds or the most two or more combinations in titanium dioxide, color lake, ferrum oxide.
8. according to the preparation method of the film coating agent according to any one of claim 1-4, it is characterised in that include
Following steps: pulverize with pulverizer after quantitative coloring agent is mixed with cellulose ether derivative, after sieving, then
Mix with acrylic resin derivant, polyvinyl alcohol, Polyethylene Glycol, to color even, prepare coating materials.
Preparation method the most according to claim 8, it is characterised in that comprise the following steps: by quantitative
Toner mixes with cellulose ether derivative 20 minutes to be pulverized with pulverizer after uniformly, after crossing 40 120 mesh sieves,
Mix 30 80 minutes with acrylic resin derivant, polyvinyl alcohol, Polyethylene Glycol again, to color even,
Prepare coating materials.
Preparation method the most according to claim 9, it is characterised in that comprise the following steps: by quantitative
Toner mixes with cellulose ether derivative 20 minutes to be pulverized with pulverizer after uniformly, after crossing 60 100 mesh sieves,
Mix 50 60 minutes with acrylic resin derivant, polyvinyl alcohol, Polyethylene Glycol again, to each position material
The aberration △ E measuring each thin film after drying and forming-film is less than 2.0, prepares coating materials.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610390377.1A CN105997918A (en) | 2016-06-03 | 2016-06-03 | Thin film coating agent for masking special smell |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610390377.1A CN105997918A (en) | 2016-06-03 | 2016-06-03 | Thin film coating agent for masking special smell |
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| CN105997918A true CN105997918A (en) | 2016-10-12 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201610390377.1A Pending CN105997918A (en) | 2016-06-03 | 2016-06-03 | Thin film coating agent for masking special smell |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106727416A (en) * | 2016-12-29 | 2017-05-31 | 上海新菲尔生物科技有限公司 | A kind of film coating pre-mix dose and preparation method for soft capsule |
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| CN103041398A (en) * | 2012-12-20 | 2013-04-17 | 天津博科林药品包装技术有限公司 | Film-coated agent for improving coating film mouthfeel of food and drug and preparation method thereof |
| CN105031660A (en) * | 2015-08-21 | 2015-11-11 | 天津博科林药品包装技术有限公司 | Film coating agent and preparation method thereof |
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2016
- 2016-06-03 CN CN201610390377.1A patent/CN105997918A/en active Pending
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| CN102421423A (en) * | 2009-05-12 | 2012-04-18 | Bpsi控股有限责任公司 | Enhanced moisture barrier immediate release film coating systems and substrates coated therewith |
| CN102847163A (en) * | 2012-10-09 | 2013-01-02 | 天津博科林药品包装技术有限公司 | Film coating agent for hygroscopic solid traditional Chinese medicine preparation and preparation method thereof |
| CN103041398A (en) * | 2012-12-20 | 2013-04-17 | 天津博科林药品包装技术有限公司 | Film-coated agent for improving coating film mouthfeel of food and drug and preparation method thereof |
| CN105031660A (en) * | 2015-08-21 | 2015-11-11 | 天津博科林药品包装技术有限公司 | Film coating agent and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106727416A (en) * | 2016-12-29 | 2017-05-31 | 上海新菲尔生物科技有限公司 | A kind of film coating pre-mix dose and preparation method for soft capsule |
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