CN104116713A - Cefdinir granule and preparation method thereof - Google Patents
Cefdinir granule and preparation method thereof Download PDFInfo
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- CN104116713A CN104116713A CN201310143706.9A CN201310143706A CN104116713A CN 104116713 A CN104116713 A CN 104116713A CN 201310143706 A CN201310143706 A CN 201310143706A CN 104116713 A CN104116713 A CN 104116713A
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Abstract
The invention relates to the technical field of medicinal preparations, and discloses a cefdinir granule and a preparation method thereof. The cefdinir granule comprises an active component cefdinir, a filler, a disintegrating agent, a flavoring, a perfume and a flow aid. The cefdinir granule is characterized in that small balls with the size of about 40 meshes are prepared by adopting an extrusion-spheronization technology or a centrifugation granulation technology, the small balls are coated by a colored film, and packaging is carried out by adopting a line-shaped band. The cefdinir granule prepared in the invention has the advantages of good mouthfeel, fast oral absorption, high bioavailability, and improvement of the medication compliance of patients especially children patients by the mixed use of the flavoring, the perfume and the colored film coating.
Description
One, technical field
The present invention relates to technical field of medicine, be specifically related to a kind of cefdinir granule and preparation method thereof.
Two, technical background
Cephalosporins medicine is powerful and strong fresh combatants in anti-infectives, the feature such as it has, and curative effect is high, side effect is little, has a broad antifungal spectrum, antibacterial activity are strong.Cephalosporins is to using crown head spore bacterium to cultivate the natural cephalosporin obtain as raw material, the class antibiotic obtaining through its side chain of semi-synthetic transformation.Cephalo element class antibiotic is the semisynthetic antibiotics that contains cephem in molecule, and it belongs to β-lactam antibiotics, is the derivant of the 7-amino-cephalo-alkanoic acid in β-lactam antibiotics.Cephalosporins, is to play bactericidal action by anti-bacteria Cell wall synthesis, stable to most beta-lactamases.
Cefdinir is the third generation oral cephalosporin of developing on the basis of cefixime, its chemical constitution feature is to introduce aminothiazole base, oximino on 7 side chains of 7-amino-cephalosporanic acid skeleton, on 3 side chains, introduce vinyl, structural formula as shown in Figure 1.Strengthened the G+ bacterium activity of (comprising MRSA) with cefixime ratio.Cefdinir has made up the shortcoming of original third generation cephalosporin a little less than to gram positive bacteria effect, becomes broad ectrum antibiotic truly.Be characterized in regard to thering is enough antibacterial abilities, avoiding the generation of drug resistance in the first stage for the treatment of.
Cefdinir is as third generation cephalosporin, and cefdinir is to G
+, G
-bacterium has broad spectrum antibiotic activity, can suppress 90%～100% clinical isolates, as the staphylococcus aureus of methicillin-sensitivity (MSSA), staphylococcus epidermidis (MSSE), streptococcus (comprising streptococcus pneumoniae), influenza blood bacillus, Klebsiella Pneumoniae, moraxelle catarrhalis, escherichia coli, even gonococcus, mucositis Blanc Chinese bacterium, indole-positive Bacillus proteus are also had to good efficacy, but invalid to Pseudomonas aeruginosa, Pseudomonas cepacia.
The present invention has developed a kind of cefdinir granule, and tool has the following advantages: 1, granule dispersion is large, and absorbability is good, is easily absorbed by the body, and is more applicable for child; 2, taking convenience, adding water can take after mixing it with water, and dosage specification is certain; 3, production technology is simple, efficient, the safe feature having in conjunction with cefdinir itself, the cefdinir granules that we develop, mouthfeel is good, oral absorption is fast, bioavailability is high, mixes and uses correctives and coloured film coating to improve the especially compliance of child patient medication of patient, has wide market prospect.
Granularity to active component in the present invention is controlled, and is less than 10 μ m.After drug micronization, can significantly improve specific surface area and the dissolution rate of insoluble drug, to the medicine being easily degraded, just can pass through the mode administrations such as transdermal, mucosa in gastrointestinal, thereby improve curative effect.Traditional method of micronization may damage active ingredient; and based on supercritical fluid (supercriticalfluid; SCF) the method for micronization mild condition of technology; be applicable to the ultra-fine drug particles of preparing tool thermal sensitivity, easily degrading; and solvent-free remnants, are conducive to medicine subsequent treatment and environmental conservation.Ultimate principle is to make solution within the extremely short time, reach height hypersaturated state, thereby makes the instantaneous formation ultra-fine grain of separating out of solute.Form oversaturated mode and be generally divided into two large classes, be supercritical solution rapid expanding (rapid expansion ofsupercritical fluid solution, RESS) and the anti-solvent of supercritical (supercritical antisolvent, and other derivative method SAS).
Three, summary of the invention
The object of the invention is to develop a kind of cefdinir granules, convenient drug administration is simple, mouthfeel good, and oral absorption is fast, and bioavailability is high, can improve the especially compliance of child patient medication of patient.
A kind of cefdinir granule of the present invention, its active component adopts supercritical fluid technology to carry out micronization, makes particle diameter be less than 10 μ m, can increase its stripping.
Object of the present invention can be achieved through the following technical solutions.
What cefdinir granules of the present invention adopted is to adopt spheronization technique or the centrifugal granulating technology extruded, by active component cefdinir, filler, binding agent, disintegrating agent, correctives, aromatic, fluidizer, formed, wherein, by active component micronization, make particle diameter be less than 10 μ m.Wherein micronized method is selected from one or more in colloid mill, jet mill, ball mill, supercritical fluid (supercritical fluid, SCF) technology, preferred supercritical fluid technology.Its method of micronization mild condition, is applicable to prepare tool thermal sensitivity, the easily ultra-fine drug particles of degraded, and solvent-free remnants, is conducive to medicine subsequent treatment and environmental conservation.
Diluent in cefdinir granules of the present invention is selected from one or more in lactose, mannitol, sucrose, sorbitol, xylitol, glucose sugar, fructose.
Binding agent in cefdinir granules of the present invention is selected from one or more in xanthan gum, arabic gum, sodium alginate, polyvinylpyrrolidone, sodium carboxymethyl cellulose, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose.
Disintegrating agent in cefdinir granules of the present invention is selected from one or more of hydroxypropyl methylcellulose, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone and carboxymethyl starch sodium of low replacement, or uses gas-producing disintegrant; Gas-producing disintegrant is selected from one or more in sodium bicarbonate and citric acid, sodium bicarbonate and tartaric acid, sodium bicarbonate and citric acid and sodium bicarbonate and fumaric acid.
Correctives in cefdinir granules of the present invention is selected from one or more in sweeting agent, aromatic, mucilage, and wherein sweeting agent is selected from one or more in aspa spy, stevioside, glucide, saccharin sodium; Aromatic is selected from one or more in orange flavor, Fructus Citri Limoniae essence, Fructus Citri tangerinae essence, Mint Essence, kiwi fruit essence, spice, Herba Menthae Rotundifoliae; Mucilage is selected from one or both in starch, arabic gum, tragcanth, sodium carboxymethyl cellulose, sodium alginate.
Fluidizer in cefdinir granules of the present invention is selected from one or more in micropowder silica gel, aerosil, magnesium stearate, Pulvis Talci, Polyethylene Glycol.
The preparation of cefdinir granules of the present invention, adopts and extrudes spheronization technique, following steps, consists of:
Step 1: pretreatment
Adjuvant was all pulverized to 100 sieves, standby; Active component is carried out to micronization, make particle diameter be less than 10 μ m, standby;
Step 2: the preparation of mixed powder
The mode that adopts equivalent to progressively increase active component, diluent, disintegrating agent, correctives, 100 mesh sieve mix homogeneously, obtain mixed powder;
Step 3: the preparation of soft material
Suitable amount of adhesive soft material processed for the mixed-powder that step 2 is made;
Step 4: the preparation of granule
Get the soft material that step 3 makes, adopt and extrude spheronization technique, make 40 object granules;
Step 5: the oven dry of granule
Get the granule that step 4 makes, under 35 ℃ of-40 ℃ of conditions, dry 3-5h, make dry granule, make its moisture lower than 3%;
Step 6: the coating of granule
Get the dry granule that step 5 makes, carry out coloured film coating;
Step 7: the coating of granule
Get the coloured particle that step 6 makes, divide and be packaged in a word band.
The preparation of cefdinir granules of the present invention, adopts centrifugal granulating technology, and centrifugal granulation is that a kind of parameter flexible adjustment is large, can realize granulation, dosing, coating integrated, following steps, consists of:
Step 1: pretreatment
Adjuvant was all pulverized to 100 sieves, standby; Active component is carried out to micronization, make particle diameter be less than 10 μ m, standby;
Step 2: the preparation of mixed powder
The mode that adopts equivalent to progressively increase active component, diluent, disintegrating agent, correctives, 100 mesh sieve mix homogeneously, obtain mixed powder;
Step 3: the preparation of granule
What the mixed-powder that step 2 is made adopted is centrifugal granulating technology, the granule of preparation 40 order left and right;
Step 4: the coating of granule
Get the micropill that step 4 makes, carry out coloured film coating,
Step 5: the packing of granule
Get the coloured particle that step 4 makes, divide and be packaged in a word band.
Four, Figure of description
The structural formula of Fig. 1 cefdinir;
Fig. 2 embodiment 1-embodiment 5 dissolution studies;
Fig. 3 embodiment 1-embodiment 5 stability studies;
Five, the specific embodiment.
Embodiment 1:
Cefdinir 100g
Lactose 600g
Sucrose 600g
Low-substituted hydroxypropyl cellulose 250g
Fructus Citri tangerinae essence 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Hydroxypropyl cellulose Q.S.
Pulvis Talci Q.S.
Make 1000
Preparation method:
Adjuvant was all pulverized to 100 sieves, standby; Active component is carried out to micronization, make particle diameter be less than 10 μ m, standby.The mode that adopts equivalent to progressively increase the lactose of active component cefdinir and recipe quantity, sucrose, low-substituted hydroxypropyl cellulose, Fructus Citri tangerinae essence, saccharin sodium, micropowder silica gel, 100 mesh sieve mix homogeneously, must mix powder, hydroxypropyl cellulose 70% alcoholic solution soft material processed, employing is extruded spheronization technique and is prepared granule, selects the order number of granule to be about 40 orders, and granule is carried out to coloured film coating, divide and be packaged in a word band, obtain.
Embodiment 2:
Cefdinir 100g
Lactose 600g
Sucrose 600g
Low-substituted hydroxypropyl cellulose 250g
Fructus Citri tangerinae essence 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Hydroxypropyl cellulose Q.S.
Pulvis Talci Q.S.
Make 1000
Preparation method:
Adjuvant was all pulverized to 100 sieves, standby; Active component is carried out to micronization, make particle diameter be less than 10 μ m, standby.The mode that adopts equivalent to progressively increase the lactose of active component cefdinir and recipe quantity, sucrose, low-substituted hydroxypropyl cellulose, Fructus Citri tangerinae essence, saccharin sodium, micropowder silica gel, 100 mesh sieve mix homogeneously, must mix powder, adopt centrifugal granulating to prepare granule, select the order number of granule to be about 40 orders, granule is carried out to coloured film coating, divide and be packaged in a word band, obtain.
Embodiment 3:
Cefdinir 100g
Lactose 1200g
Cross-linking sodium carboxymethyl cellulose 150g
Tartaric acid 50g
Sodium bicarbonate 50g
Cherry essence 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Hydroxypropyl cellulose Q.S.
Pulvis Talci Q.S.
Make 1000
Preparation method:
Adjuvant was all pulverized to 100 sieves, standby; Active component is carried out to micronization, make particle diameter be less than 10 μ m, standby.The mode that adopts equivalent to progressively increase the lactose of active component cefdinir and recipe quantity, cross-linking sodium carboxymethyl cellulose, tartaric acid, sodium bicarbonate, cherry essence, saccharin sodium, micropowder silica gel, 100 mesh sieve mix homogeneously, must mix powder, hydroxypropyl cellulose 70% alcoholic solution soft material processed, employing is extruded spheronization technique and is prepared granule, selects the order number of granule to be about 40 orders, and granule is carried out to coloured film coating, divide and be packaged in a word band, obtain.
Embodiment 4:
Cefdinir 100g
Sucrose 1200g
Crospovidone 200g
Citric acid 50g
Sodium bicarbonate 50g
Fructus Citri tangerinae essence 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Polyvinylpyrrolidone Q.S.
Pulvis Talci Q.S.
Make 1000
Preparation method:
Adjuvant was all pulverized to 100 sieves, standby; Active component is carried out to micronization, make particle diameter be less than 10 μ m, standby.The mode that adopts equivalent to progressively increase the sucrose of active component cefdinir and recipe quantity, crospovidone, citric acid, sodium bicarbonate, Fructus Citri tangerinae essence, saccharin sodium, micropowder silica gel, 100 mesh sieve mix homogeneously, must mix powder, polyvinylpyrrolidone 70% alcoholic solution soft material processed, employing is extruded spheronization technique and is prepared granule, selects the order number of granule to be about 40 orders, and granule is carried out to coloured film coating, divide and be packaged in a word band, obtain.
Embodiment 5:
Cefdinir 100g
Lactose 600g
Sucrose 400g
Sorbitol 200g
Cross-linking sodium carboxymethyl cellulose 200g
Fructus Citri Limoniae essence 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Polyvinylpyrrolidone Q.S.
Pulvis Talci Q.S.
Make 1000
Preparation method:
Adjuvant was all pulverized to 100 sieves, standby; Active component is carried out to micronization, make particle diameter be less than 10 μ m, standby.The mode that adopts equivalent to progressively increase the lactose of active component cefdinir and recipe quantity, sucrose, sorbitol, cross-linking sodium carboxymethyl cellulose, Fructus Citri Limoniae essence, saccharin sodium, micropowder silica gel, 100 mesh sieve mix homogeneously, must mix powder, adopt centrifugal granulating technology to prepare granule, select the order number of granule to be about 40 orders, granule is carried out to coloured film coating, divide and be packaged in a word band, obtain.
Embodiment 6:
Get respectively 6 bags of embodiment 1-embodiment 5, investigate its stripping behavior in pH1.0 hydrochloric acid solution, pH4.5 acetate buffer solution, pH6.8 phosphate buffer and water, the curve of the meansigma methods (%) of accumulative total stripping percentage ratio of executing routine 1-embodiment 5 each time points to time (min), the results are shown in accompanying drawing 2;
Result shows, cefdinir granule prepared by the present invention stripping behavior in four kinds of media is approximate, and 30min stripping is all greater than 80%.
Embodiment 7
Get the listing packing of embodiment 1-embodiment 5, under 40 ℃ of temperature, relative humidity 75% condition, place 6 months, respectively at 0,1,2,3 and sampling in June detect, investigate character, related substance and content, analysis result is shown in accompanying drawing 3;
Illustrate that this product is through 40 ℃, RH75% accelerated test 6 months, its character, related substance and content, all without significant change, illustrate this product (listing packing) constant product quality under this experimental condition.
Claims (9)
1. the preparation of a cefdinir granules, what it is characterized in that this granule employing is to adopt spheronization technique or the centrifugal granulating technology extruded, by active component cefdinir, filler, binding agent, disintegrating agent, correctives, aromatic, fluidizer, formed, wherein, by active component micronization, make particle diameter be less than 10 μ m.
2. the preparation of cefdinir granules according to claim 1, the micronized method that it is characterized in that active component is selected from colloid mill, jet mill, ball mill, supercritical fluid (supercritical fluid, SCF) in technology one or more, preferred supercritical fluid technology.
3. the preparation of cefdinir granules according to claim 1, is characterized in that diluent selects one or more in lactose, mannitol, sucrose, sorbitol, xylitol, glucose sugar, fructose.
4. the preparation of cefdinir granules according to claim 1, is characterized in that binding agent is selected from one or more in xanthan gum, arabic gum, sodium alginate, polyvinylpyrrolidone, sodium carboxymethyl cellulose, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose.
5. the preparation of cefdinir granules according to claim 1, it is characterized in that disintegrating agent is selected from one or more of the hydroxypropyl methylcellulose of low replacement, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone and carboxymethyl starch sodium, or use gas-producing disintegrant; Gas-producing disintegrant is selected from one or more in sodium bicarbonate and citric acid, sodium bicarbonate and tartaric acid, sodium bicarbonate and citric acid and sodium bicarbonate and fumaric acid.
6. the preparation of cefdinir granules according to claim 1, is characterized in that correctives is selected from one or more in sweeting agent, aromatic, mucilage, and wherein sweeting agent is selected from one or more in aspa spy, stevioside, glucide, saccharin sodium; Aromatic is selected from one or more in orange flavor, Fructus Citri Limoniae essence, Fructus Citri tangerinae essence, Mint Essence, kiwi fruit essence, spice, Herba Menthae Rotundifoliae; Mucilage is selected from one or both in starch, arabic gum, tragcanth, sodium carboxymethyl cellulose, sodium alginate.
7. the preparation of cefdinir granules according to claim 1, is characterized in that fluidizer is selected from one or more in micropowder silica gel, aerosil, magnesium stearate, Pulvis Talci, Polyethylene Glycol.
8. the preparation of cefdinir granules according to claim 1, what it is characterized in that granule preparation employing is to extrude spheronization technique, following steps, consists of:
Step 1: pretreatment
Adjuvant was all pulverized to 100 sieves, standby; Active component is carried out to micronization, make particle diameter be less than 10 μ m, standby;
Step 2: the preparation of mixed powder
The mode that adopts equivalent to progressively increase active component, diluent, disintegrating agent, correctives, 100 mesh sieve mix homogeneously, obtain mixed powder;
Step 3: the preparation of soft material
Suitable amount of adhesive soft material processed for the mixed-powder that step 2 is made;
Step 4: the preparation of granule
Get the soft material that step 3 makes, adopt and extrude spheronization technique, make 40 object granules;
Step 5: the oven dry of granule
Get the granule that step 4 makes, under 35 ℃ of-40 ℃ of conditions, dry 3-5h, make dry granule, make its moisture lower than 3%;
Step 6: the coating of granule
Get the dry granule that step 5 makes, carry out coloured film coating;
Step 7: the coating of granule
Get the coloured particle that step 6 makes, divide and be packaged in a word band.
9. the preparation of cefdinir granules according to claim 1, what it is characterized in that granule preparation adopts is centrifugal granulating technology, centrifugal granulation is that a kind of parameter flexible adjustment is large, can realize granulation, dosing, coating integrated, following steps, consists of:
Step 1: pretreatment
Adjuvant was all pulverized to 100 sieves, standby; Active component is carried out to micronization, make particle diameter be less than 10 μ m, standby;
Step 2: the preparation of mixed powder
The mode that adopts equivalent to progressively increase active component, diluent, disintegrating agent, correctives, 100 mesh sieve mix homogeneously, obtain mixed powder;
Step 3: the preparation of granule
What the mixed-powder that step 2 is made adopted is centrifugal granulating technology, the granule of preparation 40 order left and right;
Step 4: the coating of granule
Get the micropill that step 4 makes, carry out coloured film coating,
Step 5: the packing of granule
Get the coloured particle that step 4 makes, divide and be packaged in a word band.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310143706.9A CN104116713B (en) | 2013-04-24 | 2013-04-24 | A kind of cefdinir granule and preparation method thereof |
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| CN201310143706.9A CN104116713B (en) | 2013-04-24 | 2013-04-24 | A kind of cefdinir granule and preparation method thereof |
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| CN104116713A true CN104116713A (en) | 2014-10-29 |
| CN104116713B CN104116713B (en) | 2016-10-19 |
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| CN108653214A (en) * | 2018-06-28 | 2018-10-16 | 苏州中联化学制药有限公司 | A kind of cefdinir granules and preparation method thereof |
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| CN112545996A (en) * | 2020-12-14 | 2021-03-26 | 广州白云山光华制药股份有限公司 | Cephalosporin granules and preparation method thereof |
| CN115607553A (en) * | 2021-07-16 | 2023-01-17 | 广州白云山天心制药股份有限公司 | Cefdinir-containing medicine |
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| CN115607553A (en) * | 2021-07-16 | 2023-01-17 | 广州白云山天心制药股份有限公司 | Cefdinir-containing medicine |
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| CN104116713B (en) | 2016-10-19 |
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