CN103301068A - Cefixime dry suspension and preparation method thereof - Google Patents
Cefixime dry suspension and preparation method thereof Download PDFInfo
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- CN103301068A CN103301068A CN2013102856233A CN201310285623A CN103301068A CN 103301068 A CN103301068 A CN 103301068A CN 2013102856233 A CN2013102856233 A CN 2013102856233A CN 201310285623 A CN201310285623 A CN 201310285623A CN 103301068 A CN103301068 A CN 103301068A
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Abstract
The invention discloses a cefixime dry suspension and a preparation method thereof. The preparation comprises the following components in parts by weight: 1 part of cefixime, 0.8-4 parts of polyoxyethylated castor oil, 3-6 parts of medium-chain fatty acid glyceride, 2-6 parts of a suspending agent and 8-15 parts of a filler; the preparation method comprises the flowing steps of: dissolving cefixime in the medium-chain fatty acid glyceride with the polyoxyethylated castor oil, and subsequently absorbing by using a mixture of the suspending agent and the filler. The preparation is good in stability, rapid to dissolve, simple in process and applicable to industrial large-scale production.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of Cefixime suspension agent and preparation method thereof.
Background technology
Cefixime (Cefixime) is a kind of oral third generation cephalosporin antibiotic, chemical name: (6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-(carboxylic methoxyimino) acetylamino]-8-oxo-3-ethylene-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid trihydrate, chemical structural formula is as follows:
Cefixime be white to light yellow crystalline powder, tasteless, tool is slight special smelly, is soluble in methanol, dimethyl sulfoxine, slightly is dissolved in acetone, is insoluble in ethanol, in several water insoluble, ethyl acetates, ether, the hexane.Cefixime is as third generation oral cephalosporin class antibiotic, have has a broad antifungal spectrum, antibacterial activity is strong, gram-positive microorganism, gram-negative micro-organism, moraxelle catarrhalis (comprise and produce the enzyme strain), escherichia coli, proteus mirabilis, gonococcus (comprise and produce the enzyme strain) all there is good antibacterial activity, the advantage such as stable and side effect is little to most beta lactamases.Be applicable to the following bacterial infection disease that Streptococcus (except the enterococcus), streptococcus pneumoniae, gonococcus, branhamella catarrhalis, escherichia coli, Klebsiella, Serratia, Proteus and hemophilus influenza etc. to the cefixime sensitive organism cause: bronchitis, bronchiectasis, the secondary infection that chronic respiratory system catches, pneumonia; Pyelonephritis, cystitis, gonococcal urethritis; Cholecystitis, cholangitis; Scarlet fever; Otitis media, nasal sinusitis etc.
At present, the cefixime preparation of listing has capsule, tablet, dispersible tablet, chewable tablet, granule and dry suspension, is traditional oral administered dosage form.Because the less stable of cefixime, and bioavailability is also relatively low, medicine absorption and distribution in vivo is slower, has affected onset speed and the final curative effect of medicine, and the ordinary preparation technology is difficult to solve the instability problem of cefixime in preparation and the storage process simultaneously.
Chinese patent CN101889987A discloses a kind of new Cefixime tablets and the preparation method of capsule, and the method comprises cefixime, solubilizing agent and water soluble adjuvant micronization, dry granulation after mixing with all the other adjuvants again.Chinese patent CN101721363A discloses a kind of cefixime oral administration mixed suspension and preparation method thereof, the every 100ml of this oral administration mixed suspension consists of the following composition: cefixime 0.5～4.0g, the thickening suspending agent greater than 0 to 20.0g, cosolvent, correctives, antiseptic, all the other are non-aqueous liquid media.Chinese patent CN101606913A discloses a kind of cefixime dispersible tablet and preparation method thereof, and every contains cefixime 40～420mg, starch 0～100mg, pregelatinized Starch 0～250mg, mannitol 10～80mg, microcrystalline Cellulose 0～150mg, carboxymethylstach sodium 10～60mg, PVP K30 2～20mg, magnesium stearate 0.4～10mg, steviosin 0～10mg, orange flavor 0～10mg.Chinese patent CN101496791A discloses a kind of cefixime sustained-release tablets and preparation method thereof, this slow releasing tablet is comprised of the supplementary material of following weight proportioning: 200 parts of cefiximes (in anhydride), at least a pharmaceutically acceptable slow-release material that 20～200 parts scalable sustained drug slowly discharges fully, 20～400 parts at least a pharmaceutically acceptable excipient, the solubilizing agent of 5～100 parts at least a energy Effective Raise drug release rate.Chinese patent CN1803138A discloses a kind of cefixime oral disintegration tablet and preparation method thereof, and the weight ratio ingredient that comprises is: cefixime 10.0%～35.0%, microcrystalline Cellulose 0%～10.0%, lactose starch 0%～35.0%, mannitol 35.0%～59.0%, cross-linking sodium carboxymethyl cellulose 4.0%～15.0%, copolyvidone 1.0%～5.0%, sodium lauryl sulphate 0.01%～1.0%, micropowder silica gel 0.01%～0.5%.The cefixime preparation that above-mentioned patented technology the relates to problem that all existence and stability is relatively poor, bioavailability is relatively low.
Chinese patent CN101972231A, CN101966166A, CN101966160A, CN101966159A and CN101966154A disclose respectively dry suspension, capsule, dispersible tablet, tablet and the granule that contains cefixime liposome, and the Liposomal formulation stability of these cefiximes remains further to be improved.Chinese patent CN101711741A discloses a kind of cefixime submicro-emulsion solid preparation, owing to there not being oil phase, therefore during dissolution determination, surfactant is soluble in the aqueous phase rapidly, causes drug crystallization to be separated out, so drug-eluting and unhappy.CN102327235B discloses a kind of solid cefixime lipid nanoparticle preparation and method for making thereof, the solid lipid nano-particle preparation drug loading that provides is high, particle diameter even, medicine retention time in blood circulation is long, have better slow release and controlled-release effect, yet the liposome technology preparation is complicated, does not utilize in the production and uses.
Summary of the invention
In view of the deficiencies in the prior art, the object of the present invention is to provide that a kind of good stability, stripping are rapid, the simple Cefixime suspension agent of technique and preparation method thereof.
Particularly, the objective of the invention is to be achieved through the following technical solutions:
A kind of Cefixime suspension comprises the component of following weight portion:
Preferably, above-mentioned Cefixime suspension is prepared from by the component of following weight portion:
Further preferably, above-mentioned Cefixime suspension, wherein said medium chain length fatty acid triglyceride is selected from as follows: saturated Trivent OCG, saturated tricaprin, saturated sad-triglyceride that capric acid mixes.
Cefixime suspension of the present invention, wherein said suspending agent are selected from following one or more: sodium carboxymethyl cellulose, polyvidone, hydroxypropyl cellulose, hypromellose and xanthan gum.Preferred described suspending agent is hydroxypropyl cellulose.
Cefixime suspension of the present invention, wherein said filler are selected from following one or more: pregelatinized Starch, cyclodextrin, lactose, starch, sucrose, mannitol, calcium hydrogen phosphate and calcium sulfate.Preferred described filler is pregelatinized Starch.
Another object of the present invention provides the preparation method of above-mentioned Cefixime suspension, comprises the steps:
(1) gets cefixime, add in the Trivent OCG under the stirring condition, make dissolving, and then add polyoxyethylene castor oil, stir, get solution;
(2) with suspending agent and filler mix homogeneously, get mixture, adopt the solution of described mixture adsorption step (1), stir, carry out packing at particles packing machine, namely get Cefixime suspension.
The preparation method of Cefixime suspension of the present invention, wherein said suspending agent are selected from following one or more: sodium carboxymethyl cellulose, polyvidone, hydroxypropyl cellulose, hypromellose and xanthan gum; Described filler is selected from following one or more: pregelatinized Starch, cyclodextrin, lactose, starch, sucrose, mannitol, calcium hydrogen phosphate and calcium sulfate.
The preparation method of Cefixime suspension of the present invention, wherein said suspending agent is preferably hydroxypropyl cellulose; Described filler is preferably pregelatinized Starch.
The present invention in containing the oil phase of surfactant, utilizes the hydrophobic property of oil phase with material dissolution, has avoided extraneous moisture on the impact of medicine; Itself has anti-oxidant action oil phase, has further improved medicine stability; Simultaneously, owing to having added the surfactant polyoxyethylene Oleum Ricini, the oil phase of preparation is the Emulsion concentrated solution, and when carrying out stripping mensuration, rapid dispersion becomes emulsion, and stripping is rapid.Compared with prior art, Cefixime suspension agent that the present invention relates to and preparation method thereof has following advantage and significant progressive: (1) technique is simple, is fit to industrialized great production; (2) better stability of preparation, stripping is rapid, has improved bioavailability.
Specific embodiment
In finishing process of the present invention, the inventor considers, in order to improve medicine stability, should protect medicine to avoid moisture effects.The powder coating operation easier is large in the prior art; Add water-insoluble lipid material, such as stearic acid etc., no doubt can protect medicine, but that the unfavorable factor of bringing is drug-eluting is slack-off; The preparation liposome, the complex process such as microsphere, the industrialization difficulty is high.In order to overcome the problems referred to above, the inventor creatively proposes following imagination: if with medicine dissolution in the low viscous oil that contains surfactant, then adsorb this oil-phase solution with adjuvant, following effect will be arranged: the protection medicine, avoid moisture effects; In the stripping mensuration process, oil phase moment can be dispersed in the dissolution medium, forms microemulsion solution, the rapid stripping of medicine; Measure settling volume than the time because oil phase is similar Emulsion concentrated solution, thus can be well dispersed in the water, can layering, suspendible is respond well.Based on this, the inventor selects from a large amount of oil phases, has finally selected medium chain length fatty acid triglyceride as oil phase, and its character is a kind of colorless and odorless, low viscous lipophile isostearyl glyceryl pentaerythrityl ether, has high non-oxidizability; Surfactant is selected polyoxyethylene castor oil, because itself and medium chain length fatty acid triglyceride dissolve each other.The inventor in containing the medium chain length fatty acid triglyceride of polyoxyethylene castor oil, obtains settled solution with the cefixime material dissolution, then adsorbs this solution with adjuvant pharmaceutically commonly used, namely gets Cefixime suspension.
Following examples further describe preparation process of the present invention and beneficial effect, embodiment only is used for the purpose of illustration, do not limit the scope of the invention, apparent change and modification that while those of ordinary skills make according to the present invention are also contained within the scope of the invention.
Embodiment 1
Preparation technology:
(1) recipe quantity takes by weighing cefixime, under the stirring condition, adds in the saturated Trivent OCG, makes dissolving, then adds polyoxyethylene castor oil in this oil solution, stirs, and gets settled solution;
(2) recipe quantity takes by weighing polyvidone and pregelatinized Starch, and mix homogeneously gets mixture;
(3) solution of the mixture adsorption step (1) of usefulness step (2) stirs;
(4) carry out packing at particles packing machine, namely get Cefixime suspension.
Embodiment 2
Preparation technology:
(1) recipe quantity takes by weighing cefixime, under the stirring condition, adds in the saturated tricaprin, makes dissolving, then adds polyoxyethylene castor oil in this oil solution, stirs, and gets settled solution;
(2) recipe quantity takes by weighing lactose and sodium carboxymethyl cellulose, and mix homogeneously gets mixture;
(3) solution of the mixture adsorption step (1) of usefulness step (2) stirs;
(4) carry out packing at particles packing machine, namely get Cefixime suspension.
Embodiment 3
Preparation technology:
(1) recipe quantity takes by weighing cefixime, under the stirring condition, add sad and capric acid mol ratio and be 1:1 saturated sad-the capric acid mixed triglyceride in, make dissolving, then in this oil solution, add polyoxyethylene castor oil, stir, get settled solution;
(2) recipe quantity takes by weighing pregelatinized Starch and hydroxypropyl cellulose, and mix homogeneously gets mixture;
(3) solution of the mixture adsorption step (1) of usefulness step (2) stirs;
(4) carry out packing at particles packing machine, namely get Cefixime suspension.
The comparative example 1
Preparation technology:
(1) recipe quantity takes by weighing cefixime, under the stirring condition, add sad and capric acid mol ratio and be 1:1 saturated sad-the capric acid mixed triglyceride in, make dissolving, get settled solution;
(2) recipe quantity takes by weighing pregelatinized Starch and hydroxypropyl cellulose, and mix homogeneously gets mixture;
(3) solution of the mixture adsorption step (1) of usefulness step (2) stirs;
(4) carry out packing at particles packing machine, namely get Cefixime suspension.
The comparative example 2
Preparation technology:
(1) recipe quantity takes by weighing cefixime, under the stirring condition, add sad and capric acid mol ratio and be 1:1 saturated sad-the capric acid mixed triglyceride in, make dissolving, then in this oil solution, add Tween 80, stir, get muddy oil solution;
(2) recipe quantity takes by weighing pregelatinized Starch and hydroxypropyl cellulose, and mix homogeneously gets mixture;
(3) solution of the mixture adsorption step (1) of usefulness step (2) stirs;
(4) carry out packing at particles packing machine, namely get Cefixime suspension.
The comparative example 3
Cefixime 50g
Pregelatinized Starch 470g
Preparation technology:
Cefixime is crossed 100 mesh sieves, with pregelatinized Starch mix homogeneously, packing, namely gets Cefixime suspension.
Embodiment 4
1, dissolution test
Get respectively the sample of embodiment 1 and comparative example 1-3 preparation, test according to dissolution method (two appendix X of Chinese Pharmacopoeia version in 2010 C first method), take phosphate buffer (pH7.2) 900ml as solvent, rotating speed is that per minute 100 turns, in accordance with the law operation, in the time of 5 minutes, get solution an amount of, filter, it is an amount of that precision measures subsequent filtrate, become the solution that approximately contains cefixime 12 μ g among every 1ml with above-mentioned solvent dilution, as need testing solution; It is an amount of that other precision takes by weighing this product, add methanol an amount of (every 5mg cefixime adds methanol 2ml) and make dissolving, make the solution that approximately contains cefixime 250 μ g among every 1ml with above-mentioned solvent dilution by labelled amount, filter, it is an amount of that precision measures subsequent filtrate, make the solution that approximately contains cefixime 12 μ g among every 1ml, in contrast solution with above-mentioned solvent dilution.Get above-mentioned two kinds of solution, according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2010 A), measure respectively trap at the wavelength place of 288nm, the ratio by the two trap calculates every stripping quantity.The results are shown in Table 1.
2, related substance inspection
The sample of getting respectively embodiment 1 and comparative example 1-3 preparation is an amount of, accurately weighed, makes the solution of 1mg/ml with phosphate buffer dissolving and dilution, as need testing solution; Precision measures in right amount, makes the solution of 0.01mg/ml with the phosphate dilution, in contrast solution.According to the chromatographic condition under the assay item, injection liquid chromatography, single impurity must not be crossed 0.2 times (0.5%) of contrast solution main peak area.The results are shown in Table 2.
3, settling volume is than measuring
Get respectively each one bag in the sample of embodiment 1 and comparative example 1-3 preparation, add water 50ml, jolting 1min leaves standstill 3h, measures.The results are shown in Table 3.
Table 15min dissolution determination result
| Embodiment | 0 day (%) | 40 ℃, 75%RH accelerates 6 months (%) |
| Embodiment 1 | 99.8 | 97.9 |
| Embodiment 2 | 95.7 | 94.8 |
| Embodiment 3 | 99.4 | 98.2 |
| The comparative example 1 | 45.5 | 32.1 |
| The comparative example 2 | 50.2 | 30.2 |
| The comparative example 3 | 32.1 | 20.2 |
Can find out from the result of the test of table 1: embodiments of the invention 1-3 stripping is rapid, accelerates after 6 months under 40 ℃, the condition of 75%RH, and it is complete that 5min still can stripping; Although comparative example 1 in oil phase, does not add surfactant with medicine dissolution, when stripping is measured, the bad dispersion of oil phase, so stripping is bad; Comparative example 2 uses Tween 80 instead as surfactant, does not form Emulsion pre-concentration liquid, therefore dissolubility is bad; Comparative example's 3 usefulness oil phase and surfactants, stripping is the poorest; And the sample of comparative example 1-3 is after accelerating, and stripping all obviously descends.
The maximum single assorted measurement result of table 2 related substance
| Embodiment | 0 day (%) | 40 ℃, 75%RH accelerates 6 months (%) |
| Embodiment 1 | 0.21 | 0.34 |
| Embodiment 2 | 0.22 | 0.35 |
| Embodiment 3 | 0.20 | 0.33 |
| The comparative example 1 | 0.23 | 0.37 |
| The comparative example 2 | 0.24 | 0.39 |
| The comparative example 3 | 0.23 | 3.56 |
Can find out from the result of the test of table 2, owing to having added oil phase, therefore the related substance of embodiment 1-3 and comparative example 1-2 is all better, also change little after the accelerated test; Comparative example 3 does not add oil phase, increases obviously after related substance accelerates.
Table 3 settling volume compares measurement result
| Embodiment | Measurement result |
| Embodiment 1 | 0.95 |
| Embodiment 2 | 0.96 |
| Embodiment 3 | 0.97 |
| The comparative example 1 | 0.94 |
| The comparative example 2 | 0.94 |
| The comparative example 3 | 0.65 |
Can find out from the result of the test of table 3, the sample of embodiment 1-3 and comparative example 1-2 preparation all can meet the regulation of dry suspension; Comparative example 3 settling volume is than against regulation.
Claims (10)
1. Cefixime suspension is characterized in that: the component that comprises following weight portion:
2. Cefixime suspension according to claim 1, it is characterized in that: the component by following weight portion is prepared from:
3. Cefixime suspension according to claim 1, it is characterized in that: described medium chain length fatty acid triglyceride is selected from as follows: saturated Trivent OCG, saturated tricaprin, saturated sad-triglyceride that capric acid mixes.
4. each described Cefixime suspension according to claim 1-3 is characterized in that: described suspending agent is selected from following one or more: sodium carboxymethyl cellulose, polyvidone, hydroxypropyl cellulose, hypromellose and xanthan gum.
5. Cefixime suspension according to claim 4, it is characterized in that: described suspending agent is hydroxypropyl cellulose.
6. each described Cefixime suspension according to claim 1-3 is characterized in that: described filler is selected from following one or more: pregelatinized Starch, cyclodextrin, lactose, starch, sucrose, mannitol, calcium hydrogen phosphate and calcium sulfate.
7. Cefixime suspension according to claim 6, it is characterized in that: described filler is pregelatinized Starch.
8. the preparation method of each described Cefixime suspension is characterized in that comprising the steps: according to claim 1-3
(1) gets cefixime, add in the Trivent OCG under the stirring condition, make dissolving, and then add polyoxyethylene castor oil, stir, get solution;
(2) with suspending agent and filler mix homogeneously, get mixture, adopt the solution of described mixture adsorption step (1), stir, carry out packing at particles packing machine, namely get Cefixime suspension.
9. the preparation method of Cefixime suspension according to claim 8 is characterized in that: described suspending agent is selected from following one or more: sodium carboxymethyl cellulose, polyvidone, hydroxypropyl cellulose, hypromellose and xanthan gum; Described filler is selected from following one or more: pregelatinized Starch, cyclodextrin, lactose, starch, sucrose, mannitol, calcium hydrogen phosphate and calcium sulfate.
10. the preparation method of Cefixime suspension according to claim 8, it is characterized in that: described suspending agent is hydroxypropyl cellulose; Described filler is pregelatinized Starch.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104771368A (en) * | 2015-04-08 | 2015-07-15 | 石家庄四药有限公司 | Cefpodoxime proxetil rapid-release preparation and preparation method thereof |
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| CN1247060A (en) * | 1998-08-18 | 2000-03-15 | 灵药生物技术有限公司 | Novel medicinal compsns. containing cyclosporin |
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| JPS56100712A (en) * | 1980-01-18 | 1981-08-12 | Sankyo Co Ltd | Preparation of pharmaceutical of 7-methoxycephalosporin for rectal administration |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104771368A (en) * | 2015-04-08 | 2015-07-15 | 石家庄四药有限公司 | Cefpodoxime proxetil rapid-release preparation and preparation method thereof |
| CN104771368B (en) * | 2015-04-08 | 2017-12-22 | 石家庄四药有限公司 | Cefpodoxime Proxetil quick releasing formulation and preparation method thereof |
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