CN110075085A - A kind of roxithromycin micro-capsule and preparation method thereof - Google Patents
A kind of roxithromycin micro-capsule and preparation method thereof Download PDFInfo
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- CN110075085A CN110075085A CN201910412893.3A CN201910412893A CN110075085A CN 110075085 A CN110075085 A CN 110075085A CN 201910412893 A CN201910412893 A CN 201910412893A CN 110075085 A CN110075085 A CN 110075085A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5089—Processes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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Abstract
The invention discloses a kind of roxithromycin micro-capsules and preparation method thereof, are related to roxithromycin micro-capsule preparation field.The roxithromycin micro-capsule, including using roxithromycin as the capsule heart, and the interior coating and the outer coatings that are successively coated on outside the capsule heart, liposoluble vitamin filler is filled between interior coating and outer coatings.Compared with prior art, the beneficial effects of the present invention are: being designed using double-layer coatings, and increase liposoluble vitamin filler in two-layered coating, on the one hand, outer layer coating ensure that the mouthfeel of roxithromycin micro-capsule entirety, reduce bitter taste, on the other hand, liposoluble vitamin filler in double-layer coatings can effectively improve the absorptivity that roxithromycin is absorbed by the body, and further increase drug effect.
Description
Technical field
The present invention relates to roxithromycin microcapsule technology fields more particularly to a kind of roxithromycin micro-capsule and preparation method thereof.
Background technique
Roxithromycin is macrolide antibiotics of new generation, and mechanism of action is identical as erythromycin, mainly and bacterium
50S ribosomal subunit combines, by blocking transpeptidation and mRNA displacement to inhibit the synthesis of bacterio protein, to play antibacterial
Effect.Its main feature is that can comparatively fast enter macrophage, pneumonocyte, alveolar, in polymorphonuclear leukocyte.Roxithromycin antimicrobial spectrum with it is red
Mycin is similar, and vitro antibacterial activity is similar to erythromycin, and vivo bacteria corrosion action is 1~4 times stronger than erythromycin.Roxithromycin is to leather
Blue positive bacteria effect is slightly poorer than erythromycin, stronger than erythromycin to the effect of legionella pneumophilia.It is former to chlamydia pneumoniae, pneumonia branch
Body, the anti-microbial effect of U. urealyticum and erythromycin are similar or slightly strong.To staphylococcus aureus, (MRSA is removed roxithromycin
Outside), streptococcus (including A, B, c-type streptococcus and streptococcus pneumonia, but except G type and enterococcus), corynebacteria, Liszt
Bacterium, catarrh mora bacterium (micrococcus catarrhalis), Legionella etc. have stronger antibacterial activity;To bacteroides oralis, produce black bacteroid, digestion
The anaerobic bacterias such as coccus, peptostreptococcus, propionibacterium acnes and encephalitis toxoplasm, Chlamydia, mycoplasma, U. urealyticum,
Microspironema pallidum etc. also has a certain effect;The effects of to pylori, gonococcus, meningococcus, Bordetella pertussis, is weaker.
Roxithromycin can inhibit most of gram positive bacteria, to respiratory tract and skin infection common pathogen, as staphylococcus aureus,
The antibacterial activity of staphylococcus epidermis, pneumococcus, micrococcus scarlatinae, Bacillus influenzae, mycoplasma pneumoniae and Legionella etc. with
Erythromycin is similar.
Currently, existing Micro-Encapsulation Technique either spray drying technology, Freeze Drying Technique, extruding particle are then
Fluid-bed drying all has that coating is single, and is difficult to while guaranteeing roxithromycin by human body efficient absorption,
Cover the bitter taste of roxithromycin itself.
Summary of the invention
The technical problem to be solved by the present invention is to hide how while guaranteeing roxithromycin by human body efficient absorption
Cover the bitter taste of roxithromycin itself.
In order to solve the above technical problems, guaranteeing the present invention provides a kind of roxithromycin micro-capsule and preparation method thereof
While roxithromycin is by human body efficient absorption, the bitter taste of roxithromycin itself is covered.
A kind of roxithromycin micro-capsule, it is characterised in that: including using roxithromycin as the capsule heart, and be successively coated on outside the capsule heart
Interior coating and outer coatings, it is described it is interior coating outer coatings between be filled with liposoluble vitamin filler.
A kind of preparation method of roxithromycin micro-capsule, which is characterized in that specific steps are as follows: be placed in roxithromycin
Bottom is sprayed in fluidized bed, and hot-air is passed through, and control hot air temperature is 35~45 DEG C, so that roxithromycin suspension fluidization, then will
Fluidized bed is continuously added by the nozzle atomization that fluidized bed is sprayed at bottom in interior coating material, guarantees the interior coating material sprayed per minute
Amount is the 0.08~0.1% of the roxithromycin quality being passed through, then persistently carries out heated-air drying, and control drying temperature is 30~40
DEG C, 20~30s is kept, preceding microcapsule product is obtained, liposoluble vitamin filler solution is sprayed into fluidized bed the bottom of by again later
Fluidized bed is continuously added in nozzle atomization, guarantees that the interior coating material amount sprayed per minute is intermediate microcapsule product quality
0.1~0.14%, heated-air drying is then persistently carried out, control drying temperature is 35~40 DEG C, keeps 25~30s, obtains middle micro-capsule
Later fluidized bed is continuously added by the nozzle atomization that fluidized bed is sprayed at bottom in outer coatings material by product, and guarantee is sprayed per minute
Interior coating material amount be the 0.15~0.18% of middle microcapsule product quality, then persistently carry out heated-air drying, control drying temperature
It is 35~45 DEG C, keeps 25~28s, then cooling discharging, that is, obtain roxithromycin micro-capsule finished product of the invention.
Further, the partial size of the roxithromycin is 120~130 μm.
Further, it is described it is interior coating be hypromellose phthalate ethanol solution, concentration be 15~
20wt%.
Further, the outer coatings are methacrylic acid-butyl methacrylate methyl esters (2:1:1)
The ethanol solution of copolymer, concentration are 17~19wt%.
Further, the raw material of the liposoluble vitamin filler be carrotene, thiamine, calciferol, tocopherol,
Menadione, vitamin and fat soluble antioxidants.
Further, in the liposoluble vitamin filler each raw material weight percent are as follows: carrotene 10~
12%, thiamine 8~10%, calciferol 11~15%, tocopherol 9~12%, menadione 7~15%, citrin 11~15% and liposoluble
Property antioxidant 20~35%.
Further, the preparation method of the liposoluble vitamin filler is as follows, first configuration ethanol solution, and by rouge
Dissolubility antioxidant is added in ethanol solution to being completely dissolved, and carrotene, thiamine, calciferol, life are then added while stirring
Educate phenol, menadione and citrin, and stir 1.5~2h, active carbon particle is then added and is filtered, and adjust pH value be 6~
6.2, then passing through filtering with microporous membrane.
Further, the ethanol solution that the ethanol solution is 96%.
Compared with prior art, the beneficial effects of the present invention are: being designed using double-layer coatings, and increase in two-layered coating
Liposoluble vitamin filler, on the one hand, outer layer coating ensure that the mouthfeel of roxithromycin micro-capsule entirety, reduce bitter taste, another
Aspect, the liposoluble vitamin filler in double-layer coatings can effectively improve the absorptivity that roxithromycin is absorbed by the body, into one
Step improves drug effect.
Specific embodiment
With reference to embodiment, the present invention is furture elucidated, it should be understood that following specific embodiments are only used for
It is bright the present invention rather than limit the scope of the invention.
Embodiment 1
A kind of roxithromycin micro-capsule, including using roxithromycin as the capsule heart, and the interior coating and the outsourcing that are successively coated on outside the capsule heart
Clothing is filled with liposoluble vitamin filler between interior coating and outer coatings.
The preparation method of roxithromycin micro-capsule, specific steps in the present invention are as follows: roxithromycin is placed in bottom spray fluidized bed,
It is passed through hot-air, control hot air temperature is 45 DEG C, so that roxithromycin suspension fluidization, then passes through bottom jet flow for interior coating material
Fluidized bed is continuously added in the nozzle atomization for changing bed, guarantees that the interior coating material amount sprayed per minute is the roxithromycin being passed through
The 0.08% of quality then persistently carries out heated-air drying, and control drying temperature is 40 DEG C, keeps 20s, obtains preceding microcapsule product, it
Fluidized bed is continuously added by the nozzle atomization that fluidized bed is sprayed at bottom in liposoluble vitamin filler solution again afterwards, guarantees every point
The interior coating material amount that clock is sprayed is the 0.14% of intermediate microcapsule product quality, then persistently carries out heated-air drying, controls drying
Temperature is 35 DEG C, keeps 30s, obtains middle microcapsule product, and the nozzle atomization that outer coatings material is sprayed fluidized bed the bottom of by later is continuous
Addition fluidized bed, guarantee that the interior coating material amount sprayed per minute is the 0.15% of middle microcapsule product quality, then continue into
Row heated-air drying, control drying temperature are 45 DEG C, keep 25s, then cooling discharging, that is, obtain roxithromycin micro-capsule of the invention
Finished product.
In the present embodiment, the partial size of roxithromycin is 130 μm.
In the present embodiment, interior coating is the ethanol solution of hypromellose phthalate, and concentration is
15wt%.
In the present embodiment, outer coatings are methacrylic acid-butyl methacrylate methyl esters (2:1:1)
The ethanol solution of copolymer, concentration 19wt%.
In the present embodiment, the raw material of liposoluble vitamin filler be carrotene, thiamine, calciferol, tocopherol,
Menadione, vitamin and fat soluble antioxidants, wherein in liposoluble vitamin filler each raw material weight percent are as follows: Hu Luo
Bu Su 10%, thiamine 10%, calciferol 11%, tocopherol 12%, menadione 7%, citrin 15% and fat soluble antioxidants 20%.
In the present embodiment, the preparation method of liposoluble vitamin filler is as follows, first configuration ethanol solution, and by rouge
Dissolubility antioxidant is added in ethanol solution to being completely dissolved, and carrotene, thiamine, calciferol, life are then added while stirring
Phenol, menadione and citrin are educated, and stirs 2h, active carbon particle is then added and is filtered, and adjusting pH value is 6, is then existed
By filtering with microporous membrane, the ethanol solution that wherein ethanol solution is 96%.
Embodiment 2
A kind of roxithromycin micro-capsule, including using roxithromycin as the capsule heart, and the interior coating and the outsourcing that are successively coated on outside the capsule heart
Clothing is filled with liposoluble vitamin filler between interior coating and outer coatings.
The preparation method of roxithromycin micro-capsule, specific steps in the present invention are as follows: roxithromycin is placed in bottom spray fluidized bed,
It is passed through hot-air, control hot air temperature is 35 DEG C, so that roxithromycin suspension fluidization, then passes through bottom jet flow for interior coating material
Fluidized bed is continuously added in the nozzle atomization for changing bed, guarantees that the interior coating material amount sprayed per minute is the roxithromycin being passed through
The 0.1% of quality then persistently carries out heated-air drying, and control drying temperature is 30 DEG C, keeps 30s, obtains preceding microcapsule product, it
Fluidized bed is continuously added by the nozzle atomization that fluidized bed is sprayed at bottom in liposoluble vitamin filler solution again afterwards, guarantees every point
The interior coating material amount that clock is sprayed is the 0.1% of intermediate microcapsule product quality, then persistently carries out heated-air drying, controls drying
Temperature is 40 DEG C, keeps 25s, obtains middle microcapsule product, and the nozzle atomization that outer coatings material is sprayed fluidized bed the bottom of by later is continuous
Addition fluidized bed, guarantee that the interior coating material amount sprayed per minute is the 0.18% of middle microcapsule product quality, then continue into
Row heated-air drying, control drying temperature are 35 DEG C, keep 28s, then cooling discharging, that is, obtain roxithromycin micro-capsule of the invention
Finished product.
In the present embodiment, the partial size of roxithromycin is 120 μm.
In the present embodiment, interior coating is the ethanol solution of hypromellose phthalate, and concentration is
20wt%.
In the present embodiment, outer coatings are methacrylic acid-butyl methacrylate methyl esters (2:1:1)
The ethanol solution of copolymer, concentration 17wt%.
In the present embodiment, the raw material of liposoluble vitamin filler be carrotene, thiamine, calciferol, tocopherol,
Menadione, vitamin and fat soluble antioxidants, wherein in liposoluble vitamin filler each raw material weight percent are as follows: Hu Luo
Bu Su 12%, thiamine 8%, calciferol 15%, tocopherol 9%, menadione 15%, citrin 11% and fat soluble antioxidants 35%.
In the present embodiment, the preparation method of liposoluble vitamin filler is as follows, first configuration ethanol solution, and by rouge
Dissolubility antioxidant is added in ethanol solution to being completely dissolved, and carrotene, thiamine, calciferol, life are then added while stirring
Phenol, menadione and citrin are educated, and stirs 1.5h, active carbon particle is then added and is filtered, and adjusting pH value is 6.2, with
Passing through filtering with microporous membrane afterwards, the ethanol solution that wherein ethanol solution is 96%.
Embodiment 3
A kind of roxithromycin micro-capsule, including using roxithromycin as the capsule heart, and the interior coating and the outsourcing that are successively coated on outside the capsule heart
Clothing is filled with liposoluble vitamin filler between interior coating and outer coatings.
The preparation method of roxithromycin micro-capsule, specific steps in the present invention are as follows: roxithromycin is placed in bottom spray fluidized bed,
It is passed through hot-air, control hot air temperature is 40 DEG C, so that roxithromycin suspension fluidization, then passes through bottom jet flow for interior coating material
Fluidized bed is continuously added in the nozzle atomization for changing bed, guarantees that the interior coating material amount sprayed per minute is the roxithromycin being passed through
The 0.09% of quality then persistently carries out heated-air drying, and control drying temperature is 35 DEG C, keeps 25s, obtains preceding microcapsule product, it
Fluidized bed is continuously added by the nozzle atomization that fluidized bed is sprayed at bottom in liposoluble vitamin filler solution again afterwards, guarantees every point
The interior coating material amount that clock is sprayed is the 0.12% of intermediate microcapsule product quality, then persistently carries out heated-air drying, controls drying
Temperature is 38 DEG C, keeps 28s, obtains middle microcapsule product, and the nozzle atomization that outer coatings material is sprayed fluidized bed the bottom of by later is continuous
Addition fluidized bed, guarantee that the interior coating material amount sprayed per minute is the 0.17% of middle microcapsule product quality, then continue into
Row heated-air drying, control drying temperature are 39 DEG C, keep 27s, then cooling discharging, that is, obtain roxithromycin micro-capsule of the invention
Finished product.
In the present embodiment, the partial size of roxithromycin is 125 μm.
In the present embodiment, interior coating is the ethanol solution of hypromellose phthalate, and concentration is
18wt%.
In the present embodiment, outer coatings are methacrylic acid-butyl methacrylate methyl esters (2:1:1)
The ethanol solution of copolymer, concentration 18wt%.
In the present embodiment, the raw material of liposoluble vitamin filler be carrotene, thiamine, calciferol, tocopherol,
Menadione, vitamin and fat soluble antioxidants, wherein in liposoluble vitamin filler each raw material weight percent are as follows: Hu Luo
Bu Su 11%, thiamine 9%, calciferol 13%, tocopherol 10%, menadione 12%, citrin 13% and fat soluble antioxidants 25%.
In the present embodiment, the preparation method of liposoluble vitamin filler is as follows, first configuration ethanol solution, and by rouge
Dissolubility antioxidant is added in ethanol solution to being completely dissolved, and carrotene, thiamine, calciferol, life are then added while stirring
Phenol, menadione and citrin are educated, and stirs 1.7h, active carbon particle is then added and is filtered, and adjusting pH value is 6.1, with
Passing through filtering with microporous membrane afterwards, the ethanol solution that wherein ethanol solution is 96%.
In addition to the implementation, the present invention can also have other embodiments.It is all to use equivalent substitution or equivalent transformation shape
At technical solution, fall within the scope of protection required by the present invention.
Claims (9)
1. a kind of roxithromycin micro-capsule, it is characterised in that: including using roxithromycin as the capsule heart, and be successively coated on outside the capsule heart
Interior coating and outer coatings are filled with liposoluble vitamin filler between the interior coating and outer coatings.
2. a kind of preparation method of roxithromycin micro-capsule according to claim 1, which is characterized in that specific steps are as follows: will
Roxithromycin is placed in bottom spray fluidized bed, is passed through hot-air, and control hot air temperature is 35~45 DEG C, so that roxithromycin suspends
Then fluidized bed is continuously added by the nozzle atomization that fluidized bed is sprayed at bottom in interior coating material by fluidisation, guarantee is sprayed per minute
Interior coating material amount be the 0.08~0.1% of the roxithromycin quality being passed through, then persistently carry out heated-air drying, control drying
Temperature is 30~40 DEG C, keeps 20~30s, obtains preceding microcapsule product, later again pass through liposoluble vitamin filler solution
Fluidized bed is continuously added in the nozzle atomization of bottom spray fluidized bed, guarantees that the interior coating material amount sprayed per minute is intermediate micro-capsule
The 0.1~0.14% of product quality then persistently carries out heated-air drying, and control drying temperature is 35~40 DEG C, keeps 25~30s,
Middle microcapsule product is obtained, fluidized bed is continuously added by the nozzle atomization that fluidized bed is sprayed at bottom in outer coatings material later, is guaranteed every
The interior coating material amount that minute is sprayed is the 0.15~0.18% of middle microcapsule product quality, then persistently carries out heated-air drying, is controlled
Drying temperature processed is 35~45 DEG C, keeps 25~28s, then cooling discharging, that is, obtain roxithromycin micro-capsule finished product of the invention.
3. a kind of preparation method of roxithromycin micro-capsule according to claim 2, it is characterised in that: the roxithromycin
Partial size is 120~130 μm.
4. a kind of preparation method of roxithromycin micro-capsule according to claim 2, it is characterised in that: the interior coating is hydroxyl
The ethanol solution of third methylcellulose phthalic acid ester, concentration are 15~20wt%.
5. a kind of preparation method of roxithromycin micro-capsule according to claim 2, it is characterised in that: the outer coatings are first
Base acrylic acid-methacrylic acid butyl ester-methyl methacrylate (2:1:1) copolymer ethanol solution, concentration be 17~
19wt%.
6. a kind of preparation method of roxithromycin micro-capsule according to claim 2, it is characterised in that: the fat-soluble dimension life
The raw material of plain filler is carrotene, thiamine, calciferol, tocopherol, menadione, vitamin and fat soluble antioxidants.
7. a kind of preparation method of roxithromycin micro-capsule according to claim 2, it is characterised in that: the fat-soluble dimension life
The weight percent of each raw material in plain filler are as follows: carrotene 10~12%, thiamine 8~10%, calciferol 11~15%, life
Educate phenol 9~12%, menadione 7~15%, citrin 11~15% and fat soluble antioxidants 20~35%.
8. a kind of preparation method of roxithromycin micro-capsule according to claim 6, it is characterised in that: the fat-soluble dimension life
The preparation method of plain filler is as follows, first configuration ethanol solution, and fat soluble antioxidants are added in ethanol solution to complete
Carrotene, thiamine, calciferol, tocopherol, menadione and citrin are then added while stirring, and stirs 1.5 for dissolution
~2h is then added active carbon particle and is filtered, and adjusting pH value is 6~6.2, is then being by filtering with microporous membrane
It can.
9. a kind of preparation method of roxithromycin micro-capsule according to claim 7, it is characterised in that: the ethanol solution is
96% ethanol solution.
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN113304050A (en) * | 2021-06-07 | 2021-08-27 | 南京望知星医药科技有限公司 | Production equipment and method of roxithromycin microcapsules |
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CN102579398A (en) * | 2011-12-31 | 2012-07-18 | 沈阳药科大学 | Enteric microcapsule with function of balancing bad taste of medicament and preparation method of enteric microcapsule |
CA3062103A1 (en) * | 2017-08-15 | 2019-02-21 | Thomas Julius Borody | Compositions, devices and methods for treating autism |
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CN1318369A (en) * | 2000-04-17 | 2001-10-24 | 鲍长康 | Preparation of oral coated medicine grains |
CN1537539A (en) * | 2003-04-14 | 2004-10-20 | 上海丽珠制药有限公司 | Coated roxithromycin micro-capsule, and its prepn. method utilizing fluidized bed |
CN1893927A (en) * | 2003-10-17 | 2007-01-10 | 桑多斯股份公司 | Antibiotic composition |
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CN113304050A (en) * | 2021-06-07 | 2021-08-27 | 南京望知星医药科技有限公司 | Production equipment and method of roxithromycin microcapsules |
CN113304050B (en) * | 2021-06-07 | 2023-03-21 | 南京望知星医药科技有限公司 | Production equipment and method of roxithromycin microcapsules |
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