CN104224719A - Dry cefdinir suspension and preparation method thereof - Google Patents
Dry cefdinir suspension and preparation method thereof Download PDFInfo
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- CN104224719A CN104224719A CN201310084603.XA CN201310084603A CN104224719A CN 104224719 A CN104224719 A CN 104224719A CN 201310084603 A CN201310084603 A CN 201310084603A CN 104224719 A CN104224719 A CN 104224719A
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Abstract
The invention relates to the technical field of medicinal preparations and discloses a dry cefdinir suspension and a preparation method thereof. The dry cefdinir suspension comprises cefdinir as an active component, a filling agent, a suspending aid, a disintegrating agent, a stabilizing agent, a flavoring agent, an aromatic and a flowing aid. The active component is micronized by a supercutical fluid technology so that particle sizes are less than 10 microns, a particle sedimentation rate is reduced and solubility is improved. The dry cefdinir suspension is prepared by a dry granulation technology so that a wet granulation process under wet-heat conditions which can produce influence on stability of cefdinir as an active component is avoided, the problem of poor fluidity of direct powder mixing is solved, and production efficiency is improved. The dry cefdinir suspension has a good taste, a fast oral absorption rate and high bioavailability. Through combination of the flavoring agent and the aromatic, compliance of patients is improved and especially, compliance of children is improved.
Description
One, technical field.
The present invention relates to technical field of medicine, be specifically related to a kind of Cefdinir dry suspension agent and preparation method thereof.
Two, technical background.
Cephalosporins medicine is powerful and strong fresh combatants in anti-infectives, the features such as curative effect is high, side effect is little, has a broad antifungal spectrum, antibacterial activity are strong that it has.Cephalosporins cultivates the natural cephalosporin that obtains as raw material, the class antibiotic obtained through its side chain of semi-synthetic transformation using crown head spore bacterium.Cephalo element class antibiotic is the semisynthetic antibiotics containing 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 play bactericidal action by anti-bacteria Cell wall synthesis, stablizes most beta-lactamase.
Cefdinir is the third generation oral cephalosporin developed on the basis of cefixime, its chemical constitution feature introduces aminothiazole base, oximino on 7 side chains of 7-amino-cephalosporanic acid skeleton, vinyl introduced by 3 side chains, and structural formula as shown in Figure 1.The activity to G+ bacterium (comprising MRSA) is enhanced with cefixime ratio.Cefdinir compensate for original third generation cephalosporin shortcoming weak to gram positive bacteria effect, becomes broad ectrum antibiotic truly.Be characterized in just having enough antibacterial abilities in the first stage for the treatment of and to avoid the generation of drug resistance.
Cefdinir is as third generation cephalosporin, and cefdinir is to G
+, G
-bacterium has broad spectrum antibiotic activity, the clinical isolates of 90% ~ 100% can be suppressed, as the staphylococcus aureus (MSSA) of methicillin-sensitivity, staphylococcus epidermidis (MSSE), streptococcus (comprising streptococcus pneumoniae), influenza blood bacillus, Klebsiella Pneumoniae, moraxelle catarrhalis, escherichia coli, even also there is good efficacy to gonococcus, mucositis Blanc Chinese bacterium, indole-positive Bacillus proteus, but invalid to Pseudomonas aeruginosa, Pseudomonas cepacia.
Abbott Laboratories discloses a kind of new Cefdinir oral suspension powder (application number: 200480036573.4), employing be the direct hybrid technology of powder, also disclose preparation this suspensoid method and use this suspensoid to carry out the method for the treatment of.At present this patent belongs to and haves no right state.
Beijing HuPoGuangHua Medical Sci-Tech Development Co., Ltd's application discloses a kind of Cefdinir dry suspension agent (application number: 200710308430.X,), what adopt is wet granulation technology, be mainly used for treating the infection that staphylococcus, streptococcus, propionibacterium, gonococcus, escherichia coli, Cray diphtheria, proteus mirabilis, hemophilus influenza, Pu Luweidengsi bacterium etc. cause, as pharyngolaryngitis, tonsillitis, bronchitis, pneumonia, pyelonephritis, cystitis, gonococcal urethritis and gynecological, surgery, skin, as tissue infection etc.At present this patent is in and haves no right state.
Guangdong Hengjian Pharmaceutical Co., Ltd. discloses a kind of cephalosporin suspension granule and preparation method thereof (application number: 201010176154.8), adopts wet granulation method to prepare cephalosporin suspension granule, and applies fluidized bed drying method drying.Fluid-bed drying technology, compared with traditional oven drying, has drying time short, on the advantage such as the impact of active substance is little, not only ensure that the quality of product but also substantially increase production efficiency.
Current market existing cefdinir preparation is fewer, only has the production of capsule, granule and dispersible tablet.The present invention has developed a kind of Cefdinir dry suspension agent, compares with other dosage forms, and dry suspension tool has the following advantages: 1, dry suspension is larger than common granule dispersion, and absorbability is good, is more easily absorbed by the body, and is more applicable for child; 2, taking convenience, add water and can take after mixing it with water, dosage strengths is certain; 3, production technology is simple, suitable with common granule production equipment condition, all can produce at granule, tablet, capsule workshop.In conjunction with efficient, the safe feature that cefdinir itself has, the Cefdinir dry suspension agent that we develop has filled up the market vacancy, facilitates patient's especially child patient medication, has wide market prospect.
Simultaneously because cephalosporins raw material quality under wet, heat condition is unstable, easy degraded, the quality stability of this series products is generally poor in the market, therefore be not suitable for adopting wet granulation technology, adopt dry granulation to avoid wet-granulation process, wet heat condition is on the impact of active component cefdinir stability; Also can avoid direct powder and mix the problems such as the poor fluidity brought, improve production efficiency, obtained dry suspension mouthfeel is good, and oral absorption is fast, bioavailability is high, and correctives used in combination and aromatic improve the compliance of patient's especially child patient medication.
In the present invention, the granularity of active component is controlled, be less than 10 μm.Specific surface area and the dissolution rate of insoluble drug can be significantly improved after drug micronization, to the medicine be easily degraded in gastrointestinal just by the administration of the mode such as transdermal, mucosa, thus 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 preparing tool thermal sensitivity, easily degraded; and solvent-free remnants, be conducive to medicine subsequent treatment and environmental conservation.Ultimate principle makes solution within the extremely short time, reach height hypersaturated state, thus make the instantaneous precipitation of solute form ultra-fine grain.
Three, summary of the invention.
The object of the invention is to develop a kind of Cefdinir dry suspension agent, convenient drug administration is simple, mouthfeel good, and oral absorption is fast, and bioavailability is high, can improve the compliance of patient's especially child patient medication.
A kind of Cefdinir dry suspension agent active component of the present invention adopts supercritical fluid technology to carry out micronization, makes particle diameter be less than 10 μm, the sedimentation velocity of the particle that slows down, increases its stripping.Adopt dry granulation process to prepare Cefdinir dry suspension agent, both can avoid wet-granulation process, wet heat condition is on the impact of active component cefdinir stability; Also can avoid direct powder and mix the problems such as the poor fluidity brought, improve production efficiency.
Object of the present invention can be achieved through the following technical solutions.
What Cefdinir dry suspension agent of the present invention adopted is dry granulation process, be made up of active component cefdinir, diluent, suspending agent, disintegrating agent, stabilizing agent, correctives, fluidizer, wherein first by active component micronization, particle diameter is made to be less than 10 μm.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 the ultra-fine drug particles preparing tool thermal sensitivity, easily degraded, and solvent-free remnants, be conducive to medicine subsequent treatment and environmental conservation.
Diluent in Cefdinir dry suspension agent of the present invention selects one or more in lactose, mannitol, sucrose, sorbitol, xylitol, glucose sugar, fructose.
Suspending agent in Cefdinir dry suspension agent of the present invention is selected from one or more in xanthan gum, hydroxypropyl methylcellulose, arabic gum, sodium alginate, polyvinylpyrrolidone, carbomer, sodium carboxymethyl cellulose, gelatin, hydroxypropyl cellulose.
Disintegrating agent in Cefdinir dry suspension agent of the present invention is selected from one or more of the hydroxypropyl methylcellulose of low replacement, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone and carboxymethyl starch sodium or conbined usage 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.
Stabilizing agent in Cefdinir dry suspension agent of the present invention is selected from the one in flocculating agent, deflocculant and surfactant, preferably citric acid salt, is exactly one or more in hydrochlorate, phosphate and sodium lauryl sulphate.
Correctives in Cefdinir dry suspension agent 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 be selected from starch, arabic gum, tragcanth, sodium carboxymethyl cellulose, sodium alginate one or both.
Fluidizer in Cefdinir dry suspension agent 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 dry suspension agent of the present invention, comprises the steps:
Step 1: pretreatment
Adjuvant was all pulverized 100 sieves, for subsequent use; Active component is carried out micronization, makes particle diameter be less than 10 μm, for subsequent use;
Step 2: the preparation of mixed powder
By the mode that active component, diluent, suspending agent, disintegrating agent, stabilizing agent adopt equivalent to progressively increase, 100 mesh sieve mix homogeneously, obtain mixed powder I;
Step 3: the preparation of granule
Get the mixed powder I that step 2 is obtained, adopt dry granulation respectively, obtained granule I;
Step 4: always mix
Sieve the granule of step 3, selection granule size is the granule between 18 orders to 80 orders, is weighed, adds fluidizer and the correctives of recipe quantity, mix homogeneously, point packaging.
Four, Figure of description
The structural formula of Fig. 1 cefdinir;
Fig. 2 embodiment 1-embodiment 5 dissolution study;
Fig. 3 embodiment 1-embodiment 5 stability study.
Five, detailed description of the invention.
Embodiment 1:
Cefdinir 100g
Lactose 600g
Sucrose 600g
Hydroxypropyl methylcellulose 80g
Low-substituted hydroxypropyl cellulose 150g
Tartaric acid 50g
Sodium bicarbonate 50g
Fructus Citri tangerinae essence 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Magnesium stearate 8g
Make 1000
Preparation method:
Adjuvant was all pulverized 100 sieves, for subsequent use; Active component is carried out micronization, makes particle diameter be less than 10 μm, for subsequent use.By lactose, sucrose, hydroxypropyl methylcellulose, low-substituted hydroxypropyl cellulose, tartaric acid, the sodium bicarbonate of active component cefdinir and recipe quantity, adopt the mode that equivalent is progressively increased, 100 mesh sieve mix homogeneously, obtain mixed powder, adopt dry granulation, the size selecting granule is between 18 orders to 80 orders, weighed, added the Fructus Citri tangerinae essence of recipe quantity, saccharin sodium, micropowder silica gel and magnesium stearate, mix homogeneously, divide packaging, to obtain final product.
Embodiment 2:
Cefdinir 100g
Sucrose 1200g
Hydroxypropyl methylcellulose 80g
Low-substituted hydroxypropyl cellulose 150g
Citric acid 50g
Sodium bicarbonate 50g
Orange flavor 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Magnesium stearate 8g
Make 1000
Preparation method:
Adjuvant was all pulverized 100 sieves, for subsequent use; Active component is carried out micronization, makes particle diameter be less than 10 μm, for subsequent use.By sucrose, hydroxypropyl methylcellulose, low-substituted hydroxypropyl cellulose, citric acid, the sodium bicarbonate of active component cefdinir and recipe quantity, adopt the mode that equivalent is progressively increased, 100 mesh sieve mix homogeneously, obtain mixed powder, adopt dry granulation, the size selecting granule is between 18 orders and 80 orders, weighed, added the orange flavor of recipe quantity, saccharin sodium, micropowder silica gel and magnesium stearate, mix homogeneously, divide packaging, to obtain final product.
Embodiment 3:
Cefdinir 100g
Lactose 600g
Sucrose 600g
Sodium carboxymethyl cellulose 80g
Low-substituted hydroxypropyl cellulose 150g
Tartaric acid 50g
Sodium bicarbonate 50g
Cherry essence 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Magnesium stearate 8g
Make 1000
Preparation method:
Adjuvant was all pulverized 100 sieves, for subsequent use; Active component is carried out micronization, makes particle diameter be less than 10 μm, for subsequent use.By lactose, sucrose, sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, tartaric acid, the sodium bicarbonate of active component cefdinir and recipe quantity, adopt the mode that equivalent is progressively increased, 100 mesh sieve mix homogeneously, obtain mixed powder, adopt dry granulation, the size selecting granule is between 18 orders and 80 orders, weighed, added the cherry essence of recipe quantity, saccharin sodium, micropowder silica gel and magnesium stearate, mix homogeneously, divide packaging, to obtain final product.
Embodiment 4:
Cefdinir 100g
Sucrose 1200g
Sodium carboxymethyl cellulose 80g
Low-substituted hydroxypropyl cellulose 150g
Citric acid 50g
Sodium bicarbonate 50g
Fructus Citri tangerinae essence 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Magnesium stearate 8g
Make 1000
Preparation method:
Adjuvant was all pulverized 100 sieves, for subsequent use; Active component is carried out micronization, makes particle diameter be less than 10 μm, for subsequent use.By sucrose, sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, citric acid, the sodium bicarbonate of active component cefdinir and recipe quantity, adopt the mode that equivalent is progressively increased, 100 mesh sieve mix homogeneously, obtain mixed powder, adopt dry granulation, the size selecting granule is between 18 orders and 80 orders, its granule is weighed, adds the Fructus Citri tangerinae essence of recipe quantity, saccharin sodium, micropowder silica gel and magnesium stearate, mix homogeneously, divide packaging, to obtain final product.
Embodiment 5:
Cefdinir 100g
Lactose 600g
Sucrose 400g
Sorbitol 200g
Hydroxypropyl methylcellulose 120g
Tartaric acid 100g
Sodium bicarbonate 100g
Fructus Citri Limoniae essence 10g
Saccharin sodium 10g
Micropowder silica gel 5g
Magnesium stearate 8g
Make 1000
Preparation method:
Adjuvant was all pulverized 100 sieves, for subsequent use; Active component is carried out micronization, makes particle diameter be less than 10 μm, for subsequent use.By lactose, sucrose, sorbitol, hydroxypropyl methylcellulose, tartaric acid, the sodium bicarbonate of active component cefdinir and recipe quantity, adopt the mode that equivalent is progressively increased, 100 mesh sieve mix homogeneously, obtain mixed powder, adopt dry granulation, the size selecting granule is between 18 orders and 80 orders, the granule that granularity is suitable is weighed, and adds the Fructus Citri Limoniae essence of recipe quantity, saccharin sodium, micropowder silica gel and magnesium stearate, mix homogeneously, divide packaging, to obtain final product.
Embodiment 6:
Each 6 of Example 1-embodiment 5, investigate its dissolved corrosion in pH1.0 hydrochloric acid solution, Ph4.5 acetate buffer solution, pH6.8 phosphate buffer and water, the meansigma methods (%) executing the accumulative stripping percentage ratio of routine each time point of 1-embodiment 5, to the stripping curve of time (min), the results are shown in Figure 2;
Result shows, Cefdinir dry suspension agent prepared by the present invention dissolved corrosion in four kinds of media is similar to, and 30min stripping is all greater than 80%.
Embodiment 7
The listing packaging sample of Example 1-embodiment 5, places 6 months under temperature 40 DEG C, relative humidity 75% condition, and detect respectively at 0,1,2,3 and sampling in June, investigate character, related substance, sedimentation volume ratio, content, analysis result is shown in Fig. 3;
Illustrate that this product is through 40 DEG C, RH75% accelerated test 6 months, its character, related substance, sedimentation volume ratio, content, all without significant change, illustrate this product (listing packaging) constant product quality under this experimental condition.
Claims (10)
1. the preparation of a Cefdinir dry suspension agent, what it is characterized in that this dry suspension adopts is dry granulation process, be made up of active component cefdinir, diluent, suspending agent, disintegrating agent, stabilizing agent, correctives, fluidizer, wherein by active component micronization, particle diameter is made to be less than 10 μm.
2. the preparation of Cefdinir dry suspension agent according to claim 1, it is characterized in that the micronized method of 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 dry suspension agent according to claim 1, is characterized in that diluent selects lactose, mannitol, sucrose, sorbitol, xylitol, glucose sugar, one or more in fructose.
4. the preparation of Cefdinir dry suspension agent according to claim 1, is characterized in that one or more that suspending agent is selected from xanthan gum, arabic gum, sodium alginate, polyvinylpyrrolidone, carbomer, sodium carboxymethyl cellulose, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose.
5. the preparation of Cefdinir dry suspension agent 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 dry suspension agent according to claim 1, it is characterized in that stabilizing agent is selected from the one in flocculating agent, deflocculant and surfactant, preferably citric acid salt, is exactly one or more in hydrochlorate, phosphate and sodium lauryl sulphate.
7. the preparation of Cefdinir dry suspension agent according to claim 1, it is characterized in that one or more that correctives is selected from sweeting agent, aromatic, mucilage, 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 be selected from starch, arabic gum, tragcanth, sodium carboxymethyl cellulose, sodium alginate one or both.
8. the preparation of Cefdinir dry suspension agent according to claim 1, is characterized in that one or more that fluidizer is selected from micropowder silica gel, aerosil, magnesium stearate, Pulvis Talci, Polyethylene Glycol.
9. the preparation of Cefdinir dry suspension agent according to claim 1, is characterized in that it is made up of following steps:
Step 1: pretreatment
Adjuvant was all pulverized 100 sieves, for subsequent use; Active component is carried out micronization, makes particle diameter be less than 10 μm, for subsequent use.
10. step 2: the preparation of mixed powder
By the mode that active component, diluent, suspending agent, disintegrating agent, stabilizing agent adopt equivalent to progressively increase, 100 mesh sieve mix homogeneously, obtain mixed powder;
Step 3: the preparation of granule
Get the mixed powder that step 2 is obtained, adopt dry granulation, obtained granule;
Step 4: always mix
Sieve the granule of step 3, selection granule size is the granule between 18 orders to 80 orders, is weighed, adds fluidizer and the correctives of recipe quantity, mix homogeneously, point packaging.
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| CN201310084603.XA CN104224719A (en) | 2013-06-06 | 2013-06-06 | Dry cefdinir suspension and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104224722A (en) * | 2014-09-02 | 2014-12-24 | 河南亚卫动物药业有限公司 | Oxytetracycline dry suspension and preparation method thereof |
| CN105287599A (en) * | 2015-10-14 | 2016-02-03 | 康普药业股份有限公司 | Cefradine pharmaceutical composition |
| CN107802613A (en) * | 2017-11-13 | 2018-03-16 | 郑州大学 | Micro-nano dry suspensoid agent of a kind of taste masking enteron aisle quick-releasing type Tilmicosin and preparation method thereof |
| CN110960498A (en) * | 2019-12-25 | 2020-04-07 | 南京亿华药业有限公司 | Preparation method of heat-unstable pharmaceutical composition |
| WO2022052672A1 (en) * | 2020-09-11 | 2022-03-17 | 宁波聚焦生物医药科技股份有限公司 | Effervescent gel dry powder formulation and preparation method thereof |
| WO2023115688A1 (en) * | 2021-12-21 | 2023-06-29 | 上海奥全生物医药科技有限公司 | Rapidly dispersed suspending composition, preparation method therefor and application thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104224722A (en) * | 2014-09-02 | 2014-12-24 | 河南亚卫动物药业有限公司 | Oxytetracycline dry suspension and preparation method thereof |
| CN105287599A (en) * | 2015-10-14 | 2016-02-03 | 康普药业股份有限公司 | Cefradine pharmaceutical composition |
| CN107802613A (en) * | 2017-11-13 | 2018-03-16 | 郑州大学 | Micro-nano dry suspensoid agent of a kind of taste masking enteron aisle quick-releasing type Tilmicosin and preparation method thereof |
| CN107802613B (en) * | 2017-11-13 | 2020-01-31 | 郑州大学 | taste-masking intestinal immediate-release tilmicosin micro-nano dry suspension and preparation method thereof |
| CN110960498A (en) * | 2019-12-25 | 2020-04-07 | 南京亿华药业有限公司 | Preparation method of heat-unstable pharmaceutical composition |
| WO2022052672A1 (en) * | 2020-09-11 | 2022-03-17 | 宁波聚焦生物医药科技股份有限公司 | Effervescent gel dry powder formulation and preparation method thereof |
| WO2023115688A1 (en) * | 2021-12-21 | 2023-06-29 | 上海奥全生物医药科技有限公司 | Rapidly dispersed suspending composition, preparation method therefor and application thereof |
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