CN108685869A - A kind of clarithromycin capsule - Google Patents
A kind of clarithromycin capsule Download PDFInfo
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- CN108685869A CN108685869A CN201810830113.2A CN201810830113A CN108685869A CN 108685869 A CN108685869 A CN 108685869A CN 201810830113 A CN201810830113 A CN 201810830113A CN 108685869 A CN108685869 A CN 108685869A
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- clarithromycin
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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
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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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
- A61K9/5021—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
- 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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- Public Health (AREA)
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- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
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- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to Biaxin technical fields, and in particular to a kind of clarithromycin capsule is prepared by clarithromycin, filler, adhesive, glidant, medicinal hollow capsule and stomach dissolution type coating pre-mixing agent.The pellet of certain particle size is made in clarithromycin, filler, adhesive by the present invention, and the stability and mobility of pre-mixing agent and glidant increase pellet are coated by stomach dissolution type, is improved the quality of clarithromycin capsule, is increased the safety of medication.
Description
Technical field
The present invention relates to Biaxin technical fields, and in particular to a kind of clarithromycin capsule.
Background technology
Clarithromycin (Clarithromycin, CLM also known as carbamazepine), chemical constitution are Erythromycin A 6
On-OH be changed to-OCH3, it is macrolide antibiotics of new generation, except with erythromycin and oral beta-lactam class drug
Outside microbiological activity, in confrontation haemophilus influenzae, atypical bacteria opportunistic pathogen etc., relatively the two has stronger antibacterial activity later, separately
Its outer structure is shown after 6 upper hydroxyls of big lactonic ring are by methoxy substitution on pharmacokinetics:Hydrochloric acid in gastric juice is stablized, life is taken orally
Object availability is high, removes long half time and the feature strong to tissue penetration, thus corresponding reduction dosage and administration number of times, toxicity
It is opposite with adverse reaction to reduce, to obtain splendid face is infectd in breathing, reproduction, uropoiesis, face, skin and accessory structure
Bed evaluation.
This medicine, which belongs to, goes back greatly lactone antibiotic, and mechanism is inhibited by the connection of block cell nucleoprotein 50S subunits
The synthesis of protein and generate bacteriostasis.This medicine is to gram-positive bacteria such as staphylococcus aureus, streptococcus, pneumococcus
Etc. there is inhibiting effect, to part Gram-negative bacteria such as haemophilus influenzae, Bordetella pertussis, diplococcus, Shi Fei legions
Bacterium and part anaerobic bacteria such as fragility also have inhibiting effect like bacillus, peptostreptococcus, propionibacterium acnes.In addition to mycoplasma
Also there is inhibiting effect.This medicine feature is similar to erythromycin for antibacterial activity in vitro, but such as golden yellow Portugal of part bacterium in vivo
The antibacterial activities such as grape coccus, streptococcus, haemophilus influenzae are stronger than erythromycin.
Clarithromycin at home and abroad treats and has obtained in-depth study and extensive in bacterial respiratory tract infection disease
Using its high benefit/risk-ratio, low side effect are also welcome by numerous medical workers and patient, and demand is huge.
But the monolithic dosage of clarithromycin is larger, is 250mg, in order to which the tablet of stable content is made, needs to be added big
Filler is measured, causes monolithic volume big and leads to dysphagia, increase the medication difficulty of patient, especially pharyngeal infection
Patient.The present invention uses extrusion spheronization technique, by increasing the mobility of capsule core is made to reduce the capsule content uniformity low
Risk also reduces the weight and volume of single capsule, so that patient is swallowed easy, increases the compliance of patient.
Invention content
(One)The technical issues of solution
In view of the deficiencies of the prior art, the present invention provides a kind of preparations of low single total capsule weight of lower content uniformity risk
Method, the medication for reducing patient are difficult.
(Two)Technical solution
In order to achieve the above object, the present invention is achieved by the following technical programs:
A kind of clarithromycin capsule, which is characterized in that by clarithromycin, filler, adhesive, glidant, medicinal hollow capsule
It is prepared with stomach dissolution type coating pre-mixing agent.
Preferably, the clamycin 2 0-40 parts by weight, adhesive 2-10 parts by weight, filler 10-20 parts by weight help
Agent 0.1-2 parts by weight are flowed, stomach dissolution type is coated pre-mixing agent 1-5 parts by weight.
It is furthermore preferred that 5 parts by weight of the clamycin 2,5 parts by weight of adhesive, 15 parts by weight of filler, 2 weight of glidant
Part is measured, stomach dissolution type is coated 3 parts by weight of pre-mixing agent.
It is furthermore preferred that the filler is starch, microcrystalline cellulose, lactose, calcium monohydrogen phosphate, sorbierite or mannitol;Institute
It is talcum powder or magnesium stearate or silica to state glidant;Described adhesive is sodium carboxymethylcellulose, povidone, copolymerization dimension
Ketone, starch, pregelatinized starch, carragheen or high substituted carboxymethyl cellulose.
It is furthermore preferred that the model of the medicinal hollow capsule No. 1, No. 2 or No. 3;The stomach dissolution type is coated pre-mixing agent
Film forming agent be sodium carboxymethylcellulose or povidone.
The present invention provides the preparation methods of clarithromycin capsule, include the following steps:
1)Clarithromycin, filler are weighed, some adhesive is placed in extrusion spheronization pellet processing machine and mixes 1- under 200-400r/min
2min;
2)Remainder adhesive is added in purified water, is added 1)In the mixture, 2- is mixed under 100-200r/min
Softwood is made in 5min;
3)By 2)Described in soft ability particle is made by 20-30 mesh screens, ball is made under 1000-1500r/min in spheronizator
Core;
4)By step 3)Described in capsule core input fluid bed coating of pellets machine in, 40-50 °C of fluidized drying 30-45min;
5)Stomach dissolution type coating pre-mixing agent is dissolved in purified water, the aqueous solution of 10-15% is made;
6)By step 5)Described in Coating Solution sprayed under 40 °C by fluidized-bed coating machine, make 4)Described in drying capsule core
Wrap uniform film-coating;
7)By 6)Described in film coating pellet be added three-dimensional mixer in, be added glidant, 10r/min mixing 10min, fill
Enter in medicinal hollow capsule.
(Three)Advantageous effect
The present invention provides a kind of clarithromycin capsule, reasonable recipe, added auxiliary material without physiological activity, takes safety;System
Preparation Method is simple, is suitble to promote production.
The pellet of certain particle size is made in clarithromycin, filler, adhesive by the present invention, and is coated and is premixed by stomach dissolution type
Agent and glidant increase the stability and mobility of pellet, improve the quality of clarithromycin capsule, increase the safety of medication
Property.
The present invention uses extrusion spheronization technique, by increasing the mobility of capsule core is made to reduce the capsule content uniformity low
Risk, also reduce the weight and volume of single capsule, so that patient is swallowed easy, increase the compliance of patient.
Specific implementation mode
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below in conjunction with the embodiment of the present invention,
Technical scheme in the embodiment of the invention is clearly and completely described, it is clear that described embodiment is the present invention one
Divide embodiment, instead of all the embodiments.Based on the embodiments of the present invention, those of ordinary skill in the art are not making
The every other embodiment obtained under the premise of creative work, shall fall within the protection scope of the present invention.
Embodiment 1
A kind of clarithromycin capsule, wherein 5 parts by weight of clamycin 2,5 parts by weight of adhesive, 15 parts by weight of filler, glidant
2 parts by weight, stomach dissolution type are coated 3 parts by weight of pre-mixing agent.;
The preparation method of clarithromycin capsule, includes the following steps:
1)5 parts by weight of clamycin 2,2 parts by weight of sodium carboxymethylcellulose are weighed, 15 parts by weight of cornstarch are placed in extrusion rolling
In circle pellet processing machine 1-2min is mixed under 200-400r/min;
2)3 parts by weight of sodium carboxymethylcellulose are added in purified water, are added 1)In the mixture, mixed under 100-200r/min
It closes 2-5min and softwood is made;
3)By 2)Described in softwood particle is made by 20-30 mesh screens, ball is made under 1000-1500r/min in spheronizator
Core;
4)By step 3)Described in capsule core input fluid bed coating of pellets machine in, 40-50 °C of fluidized drying 30-45min;
5)Stomach dissolution type coating 3 parts by weight of pre-mixing agent are dissolved in purified water, the aqueous solution of 10-15% is made;
6)By step 5)Described in Coating Solution sprayed under 40 °C by fluidized-bed coating machine, make 4)Described in drying capsule core
Wrap uniform film-coating;
7)By 6)Described in film coating pellet be added three-dimensional mixer in, be added 2 parts by weight of colloidal silicon dioxide, 10r/
Min mixing 10min, are fitted into medicinal hollow capsule.
Embodiment 2
A kind of clarithromycin capsule, wherein 5 parts by weight of clamycin 2,5 parts by weight of adhesive, 15 parts by weight of filler, glidant
2 parts by weight, stomach dissolution type are coated 3 parts by weight of pre-mixing agent.;
The preparation method of clarithromycin capsule, includes the following steps:
1)5 parts by weight of clamycin 2,2 parts by weight of copolyvidone are weighed, 15 parts by weight of cornstarch are placed in extrusion spheronization pill
In machine 1-2min is mixed under 200-400r/min;
2)3 parts by weight of copolyvidone are added in purified water, are added 1)In the mixture, 2- is mixed under 100-200r/min
Softwood is made in 5min;
3)By 2)Described in softwood particle is made by 20-30 mesh screens, ball is made under 1000-1500r/min in spheronizator
Core;
4)By step 3)Described in capsule core input fluid bed coating of pellets machine in, 40-50 °C of fluidized drying 30-45min;
5)Stomach dissolution type coating 3 parts by weight of pre-mixing agent are dissolved in purified water, the aqueous solution of 10-15% is made;
6)By step 5)Described in Coating Solution sprayed under 40 °C by fluidized-bed coating machine, make 4)Described in drying capsule core
Wrap uniform film-coating;
7)By 6)Described in film coating pellet be added three-dimensional mixer in, be added 2 parts by weight of colloidal silicon dioxide, 10r/
Min mixing 10min, are fitted into medicinal hollow capsule.
Embodiment 3
A kind of clarithromycin capsule, wherein 5 parts by weight of clamycin 2,5 parts by weight of adhesive, 15 parts by weight of filler, glidant
2 parts by weight, stomach dissolution type are coated 3 parts by weight of pre-mixing agent.;
The preparation method of clarithromycin capsule, includes the following steps:
1)5 parts by weight of clamycin 2,1 parts by weight of sodium carboxymethylcellulose are weighed, 15 parts by weight of cornstarch are placed in extrusion rolling
In circle pellet processing machine 1-2min is mixed under 200-400r/min;
2)4 parts by weight of sodium carboxymethylcellulose are added in purified water, are added 1)In the mixture, mixed under 100-200r/min
It closes 2-5min and softwood is made;
3)By 2)Described in softwood particle is made by 20-30 mesh screens, ball is made under 1000-1500r/min in spheronizator
Core;
4)By step 3)Described in capsule core input fluid bed coating of pellets machine in, 40-50 °C of fluidized drying 30-45min;
5)Stomach dissolution type coating 3 parts by weight of pre-mixing agent are dissolved in purified water, the aqueous solution of 10-15% is made;
6)By step 5)Described in Coating Solution sprayed under 40 °C by fluidized-bed coating machine, make 4)Described in drying capsule core
Wrap uniform film-coating;
7)By 6)Described in film coating pellet be added three-dimensional mixer in, be added 2 parts by weight of colloidal silicon dioxide, 10r/
Min mixing 10min, are fitted into medicinal hollow capsule.
The above embodiments are merely illustrative of the technical solutions of the present invention, rather than its limitations;Although with reference to the foregoing embodiments
Invention is explained in detail, it will be understood by those of ordinary skill in the art that:It still can be to aforementioned each implementation
Technical solution recorded in example is modified or equivalent replacement of some of the technical features;And these modification or
It replaces, the spirit and scope for various embodiments of the present invention technical solution that it does not separate the essence of the corresponding technical solution.
Claims (6)
1. a kind of clarithromycin capsule, which is characterized in that by clarithromycin, filler, adhesive, glidant, medicinal hollow glue
Capsule and stomach dissolution type coating pre-mixing agent are prepared.
2. clarithromycin capsule as described in claim 1, which is characterized in that the clamycin 2 0-40 parts by weight, adhesive
2-10 parts by weight, filler 10-20 parts by weight, glidant 0.1-2 parts by weight, stomach dissolution type are coated pre-mixing agent 1-5 parts by weight.
3. clarithromycin capsule as claimed in claim 2, which is characterized in that 5 parts by weight of the clamycin 2,5 weight of adhesive
Measure part, 15 parts by weight of filler, 2 parts by weight of glidant, stomach dissolution type coating 3 parts by weight of pre-mixing agent.
4. clarithromycin capsule as claimed in claim 3, which is characterized in that the filler is starch, microcrystalline cellulose, breast
Sugar, calcium monohydrogen phosphate, sorbierite or mannitol;The glidant is talcum powder or magnesium stearate or silica;Described adhesive
For sodium carboxymethylcellulose, povidone, copolyvidone, starch, pregelatinized starch, carragheen or high substituted carboxymethyl cellulose.
5. the clarithromycin capsule as described in right 3, which is characterized in that the model of the medicinal hollow capsule No. 1, No. 2
Or No. 3;The film forming agent of the stomach dissolution type coating pre-mixing agent is sodium carboxymethylcellulose or povidone.
6. according to the preparation method of any clarithromycin capsule of Claims 1 to 5, which is characterized in that including following step
Suddenly:
1)Clarithromycin, filler are weighed, some adhesive is placed in extrusion spheronization pellet processing machine and mixes 1- under 200-400r/min
2min;
2)Remainder adhesive is added in purified water, is added 1)In the mixture, 2- is mixed under 100-200r/min
Softwood is made in 5min;
3)By 2)Described in soft ability particle is made by 20-30 mesh screens, ball is made under 1000-1500r/min in spheronizator
Core;
4)By step 3)Described in capsule core input fluid bed coating of pellets machine in, 40-50 °C of fluidized drying 30-45min;
5)Stomach dissolution type coating pre-mixing agent is dissolved in purified water, the aqueous solution of 10-15% is made;
6)By step 5)Described in Coating Solution sprayed under 40 °C by fluidized-bed coating machine, make 4)Described in drying capsule core
Wrap uniform film-coating;
7)By 6)Described in film coating pellet be added three-dimensional mixer in, be added glidant, 10r/min mixing 10min, fill
Enter in medicinal hollow capsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810830113.2A CN108685869A (en) | 2018-07-26 | 2018-07-26 | A kind of clarithromycin capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810830113.2A CN108685869A (en) | 2018-07-26 | 2018-07-26 | A kind of clarithromycin capsule |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108685869A true CN108685869A (en) | 2018-10-23 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810830113.2A Pending CN108685869A (en) | 2018-07-26 | 2018-07-26 | A kind of clarithromycin capsule |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110151722A (en) * | 2019-05-07 | 2019-08-23 | 上海新生源医药集团有限公司 | A kind of stomach dissolution type clarithromycin slow-released tablet and its production technology |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1207895A (en) * | 1997-08-12 | 1999-02-17 | 陕西省西安制药厂 | Clarithromycin capsule |
| CN103446074A (en) * | 2013-08-08 | 2013-12-18 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Clarithromycin capsule and preparation method thereof |
| CN103751151A (en) * | 2013-12-31 | 2014-04-30 | 北京万全德众医药生物技术有限公司 | Venlafaxine slow-release formulation capable of providing 24-h release result and preparation method of venlafaxine slow-release formulation |
-
2018
- 2018-07-26 CN CN201810830113.2A patent/CN108685869A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1207895A (en) * | 1997-08-12 | 1999-02-17 | 陕西省西安制药厂 | Clarithromycin capsule |
| CN103446074A (en) * | 2013-08-08 | 2013-12-18 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Clarithromycin capsule and preparation method thereof |
| CN103751151A (en) * | 2013-12-31 | 2014-04-30 | 北京万全德众医药生物技术有限公司 | Venlafaxine slow-release formulation capable of providing 24-h release result and preparation method of venlafaxine slow-release formulation |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110151722A (en) * | 2019-05-07 | 2019-08-23 | 上海新生源医药集团有限公司 | A kind of stomach dissolution type clarithromycin slow-released tablet and its production technology |
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Application publication date: 20181023 |
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