CN106924209A - Erythromycin enteric-coated tabletses and preparation method thereof - Google Patents
Erythromycin enteric-coated tabletses and preparation method thereof Download PDFInfo
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- CN106924209A CN106924209A CN201710314785.3A CN201710314785A CN106924209A CN 106924209 A CN106924209 A CN 106924209A CN 201710314785 A CN201710314785 A CN 201710314785A CN 106924209 A CN106924209 A CN 106924209A
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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
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/2813—Inorganic compounds
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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
- A61K9/282—Organic compounds, e.g. fats
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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
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Abstract
The present invention provides a kind of erythromycin enteric-coated tabletses and preparation method thereof.Using erythromycin enteric preparation release stabilization obtained in the present invention, in storage process, release stabilization, it is ensured that the quality and curative effect of the product.In enteric coating, the enteric cellulosic polymer aqueous solution coated systems neutralized using ammonia are coated, and are not in the problem of film blocking, and the surface of final product is smooth, and coatings are homogeneous, while avoiding organic solvent is coated a series of problems for bringing.
Description
Technical field
The invention belongs to field of medicaments, more particularly to a kind of erythromycin enteric-coated tabletses and preparation method thereof.
Background technology
Erythromycin, clinic is mainly used in the microbial tonsillitis of hammer, scarlet fever, diphtheria and carrier, gonorrhoea, Lee
This special bacterium disease, streptococcus pneumonia ALRI.Can also be applied to the infection of the upper respiratory tract, golden yellow Portugal that Bacillus influenzae causes
Grape coccus skin and soft tissue infection, syphilis, intestinal amebiasis etc..
There is certain defect in erythromycin design feature, its C-6, C-12 hydroxyl, and C-9 carbonyl can shape under acid catalysis
Unstable under acidic condition into ethylidene ether structure, below pH6 easily rapid decomposition loses activity, therefore is easy to by stomach when oral
Acid destruction is ineffective, causes poor bioavailability, dosage to be difficult grasp etc., therefore, it is generally prepared as enteric coated preparations.It is existing at present
Have that erythromycin enteric preparation release is unstable, in storage process, release is gradually reduced, so as to cannot ensure that the product exists
It is qualified in the term of validity, have a strong impact on the quality and curative effect of the product.
And, existing erythromycin enteric is coated and is coated using organic solvent, and is coated and can be brought with organic solvent
The aspect such as environment, economic and security a series of problems.
The content of the invention
The shortcoming of prior art in view of the above, it is an object of the invention to provide a kind of erythromycin enteric-coated tabletses and its system
Preparation Method, for solving problems present in prior art.
In order to achieve the above objects and other related objects, the present invention provides a kind of erythromycin enteric-coated tabletses, including label, isolation
Layer and enteric layer, wherein,
The label includes 50-65 mass parts erythromycin, 2.5-39.75 mass parts microcrystalline celluloses, the poly- dimension of 2-6 mass parts
Ketone, 0.5-5 mass parts Ac-Di-Sols, 2-5 mass parts PVPPs, 0.25-0.5 mass parts colloidal silicas
Silicon, 0.5-1 mass parts magnesium stearates, 5-15 mass parts sodium citrates；
The separation layer includes 10-40 mass parts Hydroxypropyl methylcelluloses, 10-20 mass parts hydroxypropyl celluloses, 10-30 matter
Amount part propane diols, 10-30 mass parts Arlacel-80s；
The enteric layer includes 40-60 mass parts hypromellose phthalates, 5-20 mass parts diacetylations
Monoglyceride, 5-10 mass parts talcum powder, 2-10 mass parts titanium dioxide, 5-30 mass parts ammonium hydroxide.
Preferably, erythromycin enteric-coated tabletses, including label, separation layer and enteric layer, wherein,
The label includes 58-61 mass parts erythromycin, and 22.5-31.25 mass parts microcrystalline celluloses, 4-5 mass parts are gathered
Dimension ketone, 2-3 mass parts Ac-Di-Sols, 3-4.5 mass parts PVPPs, 0.3-0.4 mass parts colloidal state dioxies
SiClx, 0.75-0.86 mass parts magnesium stearates, 7-10 mass parts sodium citrates；
The separation layer includes 20-30 mass parts Hydroxypropyl methylcelluloses, 13-16 mass parts hydroxypropyl celluloses, 18-21 matter
Amount part propane diols, 17-22 mass parts Arlacel-80s；
The enteric layer includes 47-52 mass parts hypromellose phthalates, 10-14 mass parts diacetylations
Monoglyceride, 7-8 mass parts talcum powder, 5-8 mass parts titanium dioxide, 15-21 mass parts ammonium hydroxide.
In order to achieve the above objects and other related objects, the present invention provides a kind of preparation method of erythromycin enteric-coated tabletses, bag
Contain,
The preparation of label：
(1) adhesive is prepared：PVP is dissolved with purified water, being subsequently adding sodium citrate makes dissolving；
(2) erythromycin and microcrystalline cellulose are poured into wet granulator in prescription ratio and is well mixed, in prescription ratio
The adhesive prepared in step (1) is added, stirring is made wet granular；
(3) wet granular that will be made is dried using in boiling drier, and it is 4.5-6.5% to dry to moisture, is used
Pelletizing machine whole grain；
(4) in prescription ratio by Ac-Di-Sol, PVPP, colloidal silica, magnesium stearate and
(3) it is obtained in during particle adds mixer and is mixed, obtains single-size；
(5) compressing tablet, using tabletting machine, is obtained label；
Bag separation layer：
Separation layer is uniformly dispersed using purified water, is coated；8-12 revs/min of drum rotation speed of setting, piece bed tempertaure
35-45℃；
Bag enteric layer：
Hypromellose phthalate, diacetylation monoglyceride, talcum powder, titanium dioxide divides in water
Dissipate, add ammonium hydroxide to make dissolving；It is coated, sets 8-15 revs/min of drum rotation speed, 35-45 DEG C of piece bed tempertaure.
Preferably, before bag separation layer, label is heated to 30-40 DEG C.
Preferably, after bag separation layer, label weightening is 2-3%.
Preferably, after bag enteric layer, enteric layer weightening is 6-7%.
As described above, erythromycin enteric-coated tabletses of the invention and preparation method thereof, have the advantages that：
Obtained erythromycin enteric preparation release stabilization of the invention, in storage process, release stabilization, it is ensured that should
The quality and curative effect of product.In enteric coating, the enteric cellulosic polymer aqueous solution coated systems neutralized using ammonia are coated,
Be not in the problem of film blocking, and the surface of final product is smooth, and coatings are homogeneous, while avoiding organic solvent bag
A series of problems that belt comes.
Brief description of the drawings
Fig. 1 is shown as 1 erythromycin enteric-coated tabletses of embodiment 0 day and long-term June stripping curve (pH6.8 media).
Specific embodiment
Embodiments of the present invention are illustrated below by way of specific instantiation, those skilled in the art can be by this specification
Disclosed content understands other advantages of the invention and effect easily.The present invention can also be by specific realities different in addition
The mode of applying is embodied or practiced, the various details in this specification can also based on different viewpoints with application, without departing from
Various modifications or alterations are carried out under spirit of the invention.
It should be clear that process equipment not specific dated in the following example or device using conventional equipment in the art or
Device；All pressure values and scope are all referring to absolute pressure.
In addition, it is to be understood that one or more method and steps mentioned in the present invention do not repel before and after the combination step
Can also there is other method step or other method step can also be inserted between the step of these are specifically mentioned, unless separately
It is described；It should also be understood that the combination annexation between one or more the equipment/devices mentioned in the present invention is not repelled
Can also exist before and after the unit equipment/device other equipment/device or two equipment/devices specifically mentioning at these it
Between can also insert other equipment/device, unless otherwise indicated.And, unless otherwise indicated, the numbering of various method steps is only
Differentiate the convenient tool of various method steps, rather than to limit the ordering of various method steps or limiting enforceable model of the invention
Enclose, being altered or modified for its relativeness is of the invention enforceable when being also considered as in the case of without essence change technology contents
Category.
Embodiment 1
Prescription is as follows：
Preparation method：
(1) adhesive is prepared：PVP is dissolved with purified water, the sodium citrate for being subsequently adding recipe quantity makes dissolving.
(2) erythromycin and microcrystalline cellulose are poured into wet granulator in prescription ratio and is well mixed, in prescription ratio
The adhesive prepared in (1) is added, stirring is made wet granular.
(3) wet granular that will be made is dried using in boiling drier, and it is 4.5%~6.5% to dry to moisture, is adopted
Use pelletizing machine whole grain.
(4) in prescription ratio by Ac-Di-Sol, PVPP, colloidal silica, magnesium stearate and
(3) it is obtained in during particle adds mixer and is mixed, obtains enteric coatel tablets single-size.
(5) compressing tablet, using tabletting machine, is obtained label.
Bag separation layer is carried out to the label：
(1) label is weighed, is placed in seed-coating machine, start seed-coating machine, label is heated to 30~40 DEG C.
(2) bag separation layer：In prescription ratio, separation layer is prepared, separation layer is uniformly dispersed using purified water, be coated
8~12 revs/min of drum rotation speed of setting, 35~45 DEG C of piece bed tempertaure.Control coating weight gain 2-3%.
Bag enteric layer：
By prescription proportions enteric layer, by the hypromellose phthalate of prescription ratio, diacetylation list
Acid glyceride, talcum powder, titanium dioxide disperses in water, adds the ammonium hydroxide of recipe quantity and makes dissolving.It is coated, setting rolling
8~15 revs/min of rotating speed of cylinder, 35~45 DEG C of piece bed tempertaure.Control coating weight gain 6-7%.
Embodiment 2
Prescription is as follows：
Preparation method：
(1) adhesive is prepared：PVP is dissolved with purified water, the sodium citrate for being subsequently adding recipe quantity makes dissolving.
(2) erythromycin and microcrystalline cellulose are poured into wet granulator in prescription ratio and is well mixed, in prescription ratio
The adhesive prepared in (1) is added, stirring is made wet granular.
(3) wet granular that will be made is dried using in boiling drier, and it is 4.5%~6.5% to dry to moisture, is adopted
Use pelletizing machine whole grain.
(4) in prescription ratio by Ac-Di-Sol, PVPP, colloidal silica, magnesium stearate and
(3) it is obtained in during particle adds mixer and is mixed, obtains enteric coatel tablets single-size.
(5) compressing tablet, using tabletting machine, is obtained label.
Bag separation layer：
(1) label is weighed, is placed in seed-coating machine, start seed-coating machine, label is heated to 30~40 DEG C.
(2) bag separation layer：In prescription ratio, separation layer is prepared, separation layer is uniformly dispersed using purified water, be coated
8~12 revs/min of drum rotation speed of setting, 35~45 DEG C of piece bed tempertaure.Control coating weight gain 2-3%.
Bag enteric layer：
By prescription proportions enteric layer, by the hypromellose phthalate of prescription ratio, diacetylation list
Acid glyceride, talcum powder, titanium dioxide disperses in water, adds the ammonium hydroxide of recipe quantity and makes dissolving.It is coated, setting rolling
8~15 revs/min of rotating speed of cylinder, 35~45 DEG C of piece bed tempertaure.Control coating weight gain 6-7%.
Embodiment 3
Prescription is as follows：
Preparation method：
(1) adhesive is prepared：PVP is dissolved with purified water, the sodium citrate for being subsequently adding recipe quantity makes dissolving.
(2) erythromycin and microcrystalline cellulose are poured into wet granulator in prescription ratio and is well mixed, in prescription ratio
The adhesive prepared in (1) is added, stirring is made wet granular.
(3) wet granular that will be made is dried using in boiling drier, and it is 4.5%~6.5% to dry to moisture, is adopted
Use pelletizing machine whole grain.
(4) in prescription ratio by Ac-Di-Sol, PVPP, colloidal silica, magnesium stearate and
(3) it is obtained in during particle adds mixer and is mixed, obtains enteric coatel tablets single-size.
(5) compressing tablet, using tabletting machine, is obtained label.
Bag separation layer and enteric coating are carried out to the label
(1) label is weighed, is placed in seed-coating machine, start seed-coating machine, label is heated to 30~40 DEG C.
(2) bag separation layer：In prescription ratio, separation layer is prepared, separation layer is uniformly dispersed using purified water, be coated
8~12 revs/min of drum rotation speed of setting, 35~45 DEG C of piece bed tempertaure.Control coating weight gain 2-3%.
(3) bag enteric layer：
By prescription proportions enteric layer, by the hypromellose phthalate of prescription ratio, diacetylation list
Acid glyceride, talcum powder, titanium dioxide disperses in water, adds the ammonium hydroxide of recipe quantity and makes dissolving.It is coated, setting rolling
8~15 revs/min of rotating speed of cylinder, 35~45 DEG C of piece bed tempertaure.Control coating weight gain 6-7%.
Test example
Erythromycin enteric-coated tabletses obtained in embodiment 1 its dissolution data see the table below, and stripping curve is shown in Fig. 1, dissolution test explanation,
Obtained erythromycin enteric preparation release stabilization of the invention, in long term storage, release stabilization.
Erythromycin enteric-coated tabletses dissolution data
Embodiment above is, in order to illustrate embodiment disclosed by the invention, can not to be interpreted as to limit of the invention
System.Additionally, method, the change of composition in various modifications listed herein and invention, are not departing from the scope of the present invention
Be obvious for those skilled in the art on the premise of spirit.Although having combined of the invention various specific
Preferred embodiment has carried out specific description to the present invention, it is to be understood that, the present invention should not be limited only to these specific embodiments.
In fact, various modifications obvious for those skilled in the art as described above should all include obtaining invention
Within the scope of the invention.
Claims (7)
1. a kind of erythromycin enteric-coated tabletses, it is characterised in that including label, separation layer and enteric layer, wherein,
The label include 50-65 mass parts erythromycin, 2.5-39.75 mass parts microcrystalline celluloses, 2-6 mass parts PVPs,
0.5-5 mass parts Ac-Di-Sols, 2-5 mass parts PVPPs, 0.25-0.5 mass parts colloidal silicas,
0.5-1 mass parts magnesium stearates, 5-15 mass parts sodium citrates；
The separation layer includes 10-40 mass parts Hydroxypropyl methylcelluloses, 10-20 mass parts hydroxypropyl celluloses, 10-30 mass parts
Propane diols, 10-30 mass parts Arlacel-80s；
The enteric layer includes 40-60 mass parts hypromellose phthalates, 5-20 mass parts diacetylation mono-acids
Glyceride, 5-10 mass parts talcum powder, 2-10 mass parts titanium dioxide, 5-30 mass parts ammonium hydroxide.
2. erythromycin enteric-coated tabletses as claimed in claim 1, it is characterised in that including label, separation layer and enteric layer, wherein,
The label include 58-61 mass parts erythromycin, 22.5-31.25 mass parts microcrystalline celluloses, 4-5 mass parts PVPs,
2-3 mass parts Ac-Di-Sols, 3-4.5 mass parts PVPPs, 0.3-0.4 mass parts colloidal silicas,
0.75-0.86 mass parts magnesium stearates, 7-10 mass parts sodium citrates；
The separation layer includes 20-30 mass parts Hydroxypropyl methylcelluloses, 13-16 mass parts hydroxypropyl celluloses, 18-21 mass parts
Propane diols, 17-22 mass parts Arlacel-80s；
The enteric layer includes 47-52 mass parts hypromellose phthalates, 10-14 mass parts diacetylation mono-acids
Glyceride, 7-8 mass parts talcum powder, 5-8 mass parts titanium dioxide, 15-21 mass parts ammonium hydroxide.
3. erythromycin enteric-coated tabletses as claimed in claim 1 or 2, it is characterised in that its preparation method, comprising,
The preparation of label：
(1) adhesive is prepared：PVP is dissolved with purified water, being subsequently adding sodium citrate makes dissolving；
(2) erythromycin and microcrystalline cellulose are poured into wet granulator in prescription ratio and is well mixed, added in prescription ratio
The adhesive prepared in step (1), stirring, is made wet granular；
(3) wet granular that will be made is dried using in boiling drier, and it is 4.5-6.5% to dry to moisture, using whole grain
Machine whole grain；
(4) in prescription ratio by Ac-Di-Sol, PVPP, colloidal silica, in magnesium stearate and (3)
It is obtained during particle adds mixer and mixes, obtains single-size；
(5) compressing tablet, using tabletting machine, is obtained label；
Bag separation layer：
Separation layer is uniformly dispersed using purified water, is coated；8-12 revs/min of drum rotation speed of setting, piece bed tempertaure 35-45
℃；
Bag enteric layer：
Hypromellose phthalate, diacetylation monoglyceride, talcum powder, titanium dioxide disperses in water, plus
Entering ammonium hydroxide makes dissolving；It is coated, sets 8-15 revs/min of drum rotation speed, 35-45 DEG C of piece bed tempertaure.
4. the preparation method of erythromycin enteric-coated tabletses as claimed in claim 1 or 2, it is characterised in that include,
The preparation of label：
(1) adhesive is prepared：PVP is dissolved with purified water, being subsequently adding sodium citrate makes dissolving；
(2) erythromycin and microcrystalline cellulose are poured into wet granulator in prescription ratio and is well mixed, added in prescription ratio
The adhesive prepared in step (1), stirring, is made wet granular；
(3) wet granular that will be made is dried using in boiling drier, and it is 4.5-6.5% to dry to moisture, using whole grain
Machine whole grain；
(4) in prescription ratio by Ac-Di-Sol, PVPP, colloidal silica, in magnesium stearate and (3)
It is obtained during particle adds mixer and mixes, obtains single-size；
(5) compressing tablet, using tabletting machine, is obtained label；
Bag separation layer：
Separation layer is uniformly dispersed using purified water, is coated；8-12 revs/min of drum rotation speed of setting, piece bed tempertaure 35-45
℃；
Bag enteric layer：
Hypromellose phthalate, diacetylation monoglyceride, talcum powder, titanium dioxide disperses in water, plus
Entering ammonium hydroxide makes dissolving；It is coated, sets 8-15 revs/min of drum rotation speed, 35-45 DEG C of piece bed tempertaure.
5. the preparation method of erythromycin enteric-coated tabletses as claimed in claim 4, it is characterised in that before bag separation layer, by label plus
Heat is to 30-40 DEG C.
6. the preparation method of erythromycin enteric-coated tabletses as claimed in claim 4, it is characterised in that after bag separation layer, label weightening is
2-3%.
7. the preparation method of erythromycin enteric-coated tabletses as claimed in claim 4, it is characterised in that after bag enteric layer, enteric layer weightening
It is 6-7%.
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Cited By (1)
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|---|---|---|---|---|
| CN109893511A (en) * | 2017-12-11 | 2019-06-18 | 湖北舒邦药业有限公司 | A kind of Dirithromycin enteric coatel tablets enteric coating, preparation method and a kind of Dirithromycin enteric coatel tablets |
| CN109893511B (en) * | 2017-12-11 | 2022-07-12 | 湖北舒邦药业有限公司 | Dirithromycin enteric-coated tablet enteric-coated coating, preparation method thereof and dirithromycin enteric-coated tablet |
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