CN103977009A - Orally-taken medicinal composition containing cefdinir and preparation method thereof - Google Patents
Orally-taken medicinal composition containing cefdinir and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an orally-taken medicinal composition containing cefdinir and UF711-type microcrystalline cellulose. A cefdinir orally-taken solid preparation is prepared by a powder direct pellet method. The medicinal composition and preparation method thereof can effectively reduce content of impurities in the cefdinir orally-taken solid preparation, and is beneficial to improving and controlling quality and stability of preparation products.
Description
Technical field
The present invention relates to composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose and preparation method thereof.
Background technology
Cefdinir, chemistry is by name: (6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-hydroxyl imide base acetylamino]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid, chemical structural formula is as follows:
Cefdinir belongs to oral third generation cephalosporin, is the oral cephalosporin of developing on the basis of cefixime, and its chemical constitution feature is that the hydroxyl methoxyimino on 7 side chains of cefixime is substituted by oximino.Compare with cefixime, ceftibuten, cefpodoxime, cefaclor, cefdinir is active strong to G+ bacterium; And for G-bacterium, its antibacterial activity is similar to cefixime, be obviously better than cefaclor.Cefdinir can be used for treating tonsillitis, sinusitis, otitis media, acute bronchitis, pneumonia, abdominal cavity, urogenital infections etc., is widely used in clinically catching that the sensitive bacterials such as inside and outside section, department of dermatologry, department of obstetrics and gynecology, urology department cause.Clinical studies show, the treated effect that cefdinir infects for sensitive organism reaches 82%, and side effect incidence rate is 3%, is a kind of efficient, safe cephalosporin antibacterial.
Cefdinir crude drug is micro-yellow powder, and poorly water-soluble easily produces static, and poor fluidity, all unstable to conditions such as wet, heat, light.If production environment exists wet, heat, the conditions such as high light, will produce impact in various degree to the quality of cefdinir product and stability, cause the rising of impurity, especially degradation impurity A[chemistry is by name: 2 (R)-2-[(Z)-2-(thiazolamine-4-yl)-2-(oxyimino) acetylamino]-2-[(2RS, 5RS)-5-methyl-7-oxo-2, 4, 5, 7-tetrahydrochysene-1H-furo [3, 4-d] [1, 3] thiazine-2-yl] acetic acid] and isomer impurities VII[chemistry by name: (6R, 7R)-7-[(E)-2-(thiazolamine-4-base-)-2-(oxyimino) acetylamino]-8-oxo-3-vinyl-5-sulfo--1-azabicyclo [4.2.0] octane-2-alkene-2-carboxylic acid].The rising of impurity, even exceeds standard, and will have a strong impact on safety and the effectiveness of product.Therefore, the preparation of Cefdinir oral preparation should avoid existing the conditions such as wet, heat and high light as far as possible.
Conventional wet granulation technique is obviously not suitable for the production and preparation of Cefdinir oral preparation.Chinese patent CN201210583506.0 discloses the method that dry granulation is prepared Cefdinir dispersible tablet, and the method is squeezed into after block by the supplementary material dry method internally adding in advance, smashes granulation, then carry out tabletting.This method has been avoided water and the heat of wet granulation technique introducing, has improved to a certain extent quality and the stability of product.But the related dry granulation of the method presents some drawbacks in amplifying production continuously.One, dry method extruding continued operation meeting makes the heat production of dry granulating machine roller, if cooling control is not in place, will affect product quality and stability; Its two, roller heat production causes sticky wheel phenomenon immediately, adds a part of lubricant in need to be when extruding is granulated, such as magnesium stearate, to prevent sticky wheel.And in add the impact that lubricant may be certain on the mass formation of product, especially may affect the stability of product dissolution; Its three, although that dry granulation has been avoided is damp and hot, but still need to granulate, granulate link, technique is loaded down with trivial details, poor controllability.
Summary of the invention
The object of this invention is to provide the composition for oral liquid that contains cefdinir, can be used for preparing cefdinir sheet and dispersible tablet.The invention solves Cefdinir oral preparation in preparation process to wet and heat-labile problem, be conducive to reduce and control the impurity content in cefdinir oral formulations, improved quality and the stability of formulation products.
Direct powder compression is a kind of comparatively ideal preparation method of oral solid formulation.Direct powder compression not only can reduce production costs, and can also greatly improve disintegrating property and the dissolution of tablet, and the strong adaptability of technique, is conducive to large-scale industrialization and produces.But realize last vertical compression, prescription and technique are needed to several preconditions: (1) mixture of powders should have good mobility; (2) mixture of powders should have good formability; (3), for improving formability and the mobility of powder, when adding adjuvant, the size that should control slice, thin piece is unsuitable excessive.
Cefdinir crude drug is after pulverizing, and mobility is very poor, and 40%～60% cefdinir drug content also can cause the low compressibility of material.As for improving mobility and the compressibility of powder, select conventional adjuvant, need larger adjuvant amount, this will make slice, thin piece oversize, thereby affects the effect of direct compression.Therefore, selecting the medical additive of a kind of high formability, high fluidity, low use amount is to adopt direct powder compression to prepare the key of Cefdinir oral preparation.
UF711 microcrystalline Cellulose is a kind of novel microcrystalline Cellulose with high fluidity and high formability, by chemical company of Asahi Chemical Industry recent development.Its high fluidity and high-mouldability are the manufacturing technologies that depends on cellulose and particle.UF711 is comprised of the particle of justifying and assemble, and makes itself and PH102 have identical angle of repose (42 °), presents high fluidity.Its particle has loose structure in addition, for it brings plastic deformation, has identical bulk density (0.22g/cm3) with KG-802, presents high-mouldability.Select the UF711 microcrystalline Cellulose of high fluidity and high-mouldability when reducing material usage, to guarantee the high-mouldability of product and the optimization of mobility, thereby to enhance productivity.
Cefdinir oral Pharmaceutical composition provided by the present invention, by adding appropriate UF-711 microcrystalline Cellulose to be achieved direct powder compression.Due to the excellent characteristic of UF711 microcrystalline Cellulose, make the comparable ordinary microcrystalline cellulose of its consumption reduce 30～60%, when having guaranteed high-mouldability and high fluidity, can effectively reduce the size of Cefdinir oral tablet or dispersible tablet.
The composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention, is characterized in that adopting direct powder compression to prepare Cefdinir oral solid preparation.
Adopt the prepared Cefdinir oral solid preparation of composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention, in per unit dosage form, contain cefdinir 50mg or 100mg.
Adopt the prepared Cefdinir oral solid preparation of composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention, the percentage by weight that contains UF711 type microcrystalline Cellulose in per unit dosage form is 5%～40%, preferably 10%～20%.
The composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention can be used to prepare cefdinir sheet and dispersible tablet.
Adopt prescription composition and the percentage by weight thereof of the prepared cefdinir sheet of the composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention to be: 40%～60% cefdinir, 10%～20% UF711 type microcrystalline Cellulose, 10%～30% lactose, 3%～7% hyprolose and 0.5%～2.0% magnesium stearate.
Adopt the preparation method of cefdinir sheet prepared by the composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention as follows:
The first step, crosses 200 mesh sieves after cefdinir crude drug is pulverized standby;
Second step, crosses 100 mesh sieves after all adjuvants are dried standby;
The 3rd step, takes cefdinir, UF711 type microcrystalline Cellulose, lactose and the hyprolose of recipe quantity, mix homogeneously;
The 4th step, after said mixture is mixed with magnesium stearate again, carries out tabletting, obtains.
Adopt the above composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention and preparation method thereof prepared cefdinir sheet, the dissolution at 30 minutes is greater than 95%.
Adopt prescription composition and the percentage by weight thereof of the prepared Cefdinir dispersible tablet of the composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention to be: 40%～60% cefdinir, 10%～20% UF711 type microcrystalline Cellulose, 10%～30% lactose, 3%～7% hyprolose, 4%～8% cross-linking sodium carboxymethyl cellulose, 2%～4% aspartame and 0.5%～2.0% magnesium stearate.
Adopt the preparation method of Cefdinir dispersible tablet prepared by the composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention as follows:
The first step, crosses 200 mesh sieves after cefdinir crude drug is pulverized standby;
Second step, crosses 100 mesh sieves after all adjuvants are dried standby;
The 3rd step, takes cefdinir, UF711 type microcrystalline Cellulose, lactose, hyprolose, the cross-linking sodium carboxymethyl cellulose mix homogeneously of recipe quantity;
The 4th step, after said mixture is mixed with aspartame and magnesium stearate again, carries out tabletting, obtains.
By adopting the above composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention and preparation method thereof prepared Cefdinir dispersible tablet to be placed in the water of 15～25 ℃, in 3 minutes, can all disperse and pass through 24 mesh sieves.
Adopt the above composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention and the prepared Cefdinir dispersible tablet of preparation method, the dissolution at 15 minutes is greater than 95%.
Compare with additive method, adopt the above composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention and preparation method thereof prepared cefdinir sheet and dispersible tablet, there is higher quality and better stability, can better control the impurity of cefdinir sheet and dispersible tablet, especially degradation impurity A and isomer impurities VII.And, and additive method compares, and adopts above composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose provided by the present invention and preparation method thereof prepared cefdinir sheet and dispersible tablet, has more high-dissolution.
The specific embodiment
Following exemplary embodiments is used for illustrating the present invention, within the simple replacement of the present invention being done those skilled in the art or improvement etc. all belong to the technical scheme that the present invention protects.
Embodiment 1:
The preparation of cefdinir sheet (dry granulation)
Prescription forms:
Preparation technology:
(1) it is standby that cefdinir, lactose are crossed respectively 200 mesh sieves after crushed, and it is standby that other adjuvants are crossed 100 mesh sieves after drying;
(2) take cefdinir, lactose, microcrystalline Cellulose, the polyvinylpolypyrrolidone of recipe quantity 50% and the magnesium stearate of recipe quantity 30% of recipe quantity, mix homogeneously;
(3) by dry method, be squeezed into block, smash, 18 mesh sieves are granulated, 16 order granulate;
(4) add polyvinylpolypyrrolidone and the magnesium stearate of surplus, after mix homogeneously, tabletting.
Embodiment 2:
The preparation of cefdinir sheet (direct powder compression)
Prescription forms:
Preparation technology:
(1) standby by crossing 200 mesh sieves after the pulverizing of cefdinir crude drug;
(2) standby by crossing 100 mesh sieves after all adjuvants oven dry;
(3) take cefdinir, UF711 type microcrystalline Cellulose, lactose and the hyprolose of recipe quantity, mix homogeneously;
(4) after said mixture is mixed with magnesium stearate, carry out tabletting again, obtain.
Embodiment 3:
The preparation of cefdinir sheet (direct powder compression)
Prescription forms:
Preparation technology:
(1) standby by crossing 200 mesh sieves after the pulverizing of cefdinir crude drug;
(2) standby by crossing 100 mesh sieves after all adjuvants oven dry;
(3) take cefdinir, UF711 type microcrystalline Cellulose, lactose and the hyprolose of recipe quantity, mix homogeneously;
(4) after said mixture is mixed with magnesium stearate, carry out tabletting again, obtain.
Embodiment 4:
The preparation of Cefdinir dispersible tablet (dry granulation)
Prescription forms:
Preparation technology:
(1) it is standby that cefdinir, lactose are crossed respectively 200 mesh sieves after crushed, and it is standby that other adjuvants are crossed 100 mesh sieves after drying;
(2) take cefdinir, lactose, the microcrystalline Cellulose of recipe quantity, the magnesium stearate of the polyvinylpolypyrrolidone of recipe quantity 50% and recipe quantity 30%, mix homogeneously;
(3) by dry method, be squeezed into block, smash, 18 mesh sieves are granulated, 16 order granulate;
(4) add the polyvinylpolypyrrolidone of surplus, the magnesium stearate of the aspartame of recipe quantity and recipe quantity 70%, after mix homogeneously, tabletting.
Embodiment 5:
The preparation of Cefdinir dispersible tablet (direct powder compression)
Prescription forms:
Preparation technology:
(1) standby by crossing 200 mesh sieves after the pulverizing of cefdinir crude drug;
(2) standby by crossing 100 mesh sieves after all adjuvants oven dry;
(3) take cefdinir, UF711 type microcrystalline Cellulose, lactose, hyprolose, the cross-linking sodium carboxymethyl cellulose mix homogeneously of recipe quantity;
(4) after said mixture is mixed with aspartame and magnesium stearate, carry out tabletting again, obtain.
Embodiment 6:
The preparation of Cefdinir dispersible tablet (direct powder compression)
Prescription forms:
Preparation technology:
(1) standby by crossing 200 mesh sieves after the pulverizing of cefdinir crude drug;
(2) standby by crossing 100 mesh sieves after all adjuvants oven dry;
(3) take cefdinir, UF711 type microcrystalline Cellulose, lactose, hyprolose, the cross-linking sodium carboxymethyl cellulose mix homogeneously of recipe quantity;
(4) after said mixture is mixed with aspartame and magnesium stearate, carry out tabletting again, obtain.
Embodiment 7:
Dissolution determination
Assay method: lucifuge operation.Get test sample, according to dissolution method (two appendix X C the second methods of Chinese Pharmacopoeia version in 2010), hydrochloric acid solution (dilute hydrochloric acid 24 → 1000) 900ml of take is dissolution medium, rotating speed is per minute 50 to turn, operation in accordance with the law, in the time of 30 minutes, get solution appropriate, filter, it is appropriate that precision measures subsequent filtrate, puts in brown bottle, with above-mentioned hydrochloric acid solution dilution, makes the solution that contains 10 μ g in every 1ml, according to ultraviolet visible spectrophotometry (two appendix IV A of Chinese Pharmacopoeia version in 2010), at the wavelength place of 280nm, measure absorbance; Separately get cefdinir reference substance appropriate, accurately weighed, put in brown bottle, add phosphate buffer (pH7.0) and dissolve and dilute the solution of making in every 1ml containing 250 μ g, filter, it is appropriate that precision measures subsequent filtrate, put in brown bottle, with above-mentioned hydrochloric acid solution dilution, make the solution that contains 10 μ g in every 1ml, be measured in the same method, calculate the stripping quantity of every.
Adopt above assay method, the sample prepared to embodiment 1～6 carried out dissolution determination, and measurement result is in Table 1.
Table 1: dissolution determination result
| Embodiment | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 |
| Measurement result | 82.1％ | 97.3％ | 97.8％ | 85.6％ | 97.5％ | 97.2％ |
Embodiment 8:
The detection of degradation impurity A and isomer impurities VII
Detection method: it is appropriate that precision takes test sample fine powder, under lucifuge condition, adds after phosphate buffer (pH7.0) dissolving, with mobile phase A dilution, makes the solution that contains cefdinir 1.5mg in every 1ml, filters, and gets subsequent filtrate as need testing solution; Precision measures 1ml, puts in 100ml measuring bottle, adds mobile phase A and is diluted to scale, shakes up, in contrast solution.According to high performance liquid chromatography (two appendix V D of Chinese Pharmacopoeia version in 2010), measure, employing octadecylsilane chemically bonded silica is filler; Mobile phase A is 0.1% tetramethyl ammonium hydroxide solution (with phosphorus acid for adjusting pH value to 5.5) 1000ml, add 0.1mol/L Calcium Disodium Versenate solution 0.4ml, Mobile phase B is 0.1% tetramethyl ammonium hydroxide solution (with phosphorus acid for adjusting pH value to 5.5)-acetonitrile-methanol (500:300:200), add 0.1mol/L Calcium Disodium Versenate solution 0.4ml, linear gradient eluting.Column temperature is 40 ℃, and detection wavelength is 254nm.Get cefdinir reference substance appropriate, add after phosphate buffer (pH7.0) dissolving, add mobile phase A dilution and make the solution that approximately contains 1.5mg in every 1ml, in heating in water bath 30 minutes, let cool to room temperature, get 20 μ l injection liquid chromatographies, record chromatogram, the retention time at cefdinir peak is about 20 minutes, and number of theoretical plate calculates and should be not less than 7000 by cefdinir peak, and the separating degree of cefdinir peak and adjacent impurity peaks should be not less than 1.0.Get contrast solution 20 μ l, injection liquid chromatography, regulates detection sensitivity, makes the peak height of main constituent chromatographic peak be about 20% of full scale, and precision measures need testing solution and each 20 μ l of contrast solution, and injection liquid chromatography, records chromatogram respectively.
Adopt above assay method, to the prepared sample of embodiment 1～6, at 0 day with under accelerated test condition, (40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%), in the time of 30 days, carries out the detection of degradation impurity A and isomer impurities VII.Testing result is in Table 2.
The testing result of table 2: degradation impurity A and isomer impurities VII
Claims (11)
1. the composition for oral liquid that contains cefdinir and UF711 type microcrystalline Cellulose, is characterized in that adopting direct powder compression to prepare Cefdinir oral solid preparation.
2. Pharmaceutical composition according to claim 1, is characterized in that in unit dosage forms containing cefdinir 50mg or 100mg.
3. Pharmaceutical composition according to claim 1, the percentage by weight that it is characterized in that containing UF711 type microcrystalline Cellulose in unit dosage forms is 5% ~ 40%, preferably 10% ~ 20%.
4. according to the Pharmaceutical composition described in claim 1 ~ 3, it is characterized in that described Cefdinir oral solid preparation is cefdinir sheet and Cefdinir dispersible tablet.
5. according to the Pharmaceutical composition described in claim 1 ~ 4, it is characterized in that prescription composition and the percentage by weight thereof of described cefdinir sheet is: 40% ~ 60% cefdinir, 10% ~ 20% UF711 type microcrystalline Cellulose, 10% ~ 30% lactose, 3% ~ 7% hyprolose and 0.5% ~ 2.0% magnesium stearate.
6. according to the Pharmaceutical composition described in claim 1 ~ 5, it is characterized in that the preparation method of described cefdinir sheet is as follows:
The first step, crosses 200 mesh sieves after cefdinir crude drug is pulverized standby;
Second step, crosses 100 mesh sieves after all adjuvants are dried standby;
The 3rd step, takes cefdinir, UF711 type microcrystalline Cellulose, lactose and the hyprolose of recipe quantity, mix homogeneously;
The 4th step, after said mixture is mixed with magnesium stearate again, carries out tabletting, obtains.
7. according to the Pharmaceutical composition described in claim 1 ~ 6, it is characterized in that the described cefdinir sheet dissolution of 30 minutes is greater than 95%.
8. according to the Pharmaceutical composition described in claim 1 ~ 4, it is characterized in that prescription composition and the percentage by weight thereof of described Cefdinir dispersible tablet is: 40% ~ 60% cefdinir, 10% ~ 20% UF711 type microcrystalline Cellulose, 10% ~ 30% lactose, 3% ~ 7% hyprolose, 4% ~ 8% cross-linking sodium carboxymethyl cellulose, 2% ~ 4% aspartame and 0.5% ~ 2.0% magnesium stearate.
9. according to the Pharmaceutical composition described in claim 1 ~ 4 and 8, it is characterized in that the preparation method of described Cefdinir dispersible tablet is as follows:
The first step, crosses 200 mesh sieves after cefdinir crude drug is pulverized standby;
Second step, crosses 100 mesh sieves after all adjuvants are dried standby;
The 3rd step, takes cefdinir, UF711 type microcrystalline Cellulose, lactose, hyprolose, the cross-linking sodium carboxymethyl cellulose mix homogeneously of recipe quantity;
The 4th step, after said mixture is mixed with aspartame and magnesium stearate again, carries out tabletting, obtains.
10. according to the Pharmaceutical composition described in claim 1 ~ 4 and 8 ~ 9, it is characterized in that described Cefdinir dispersible tablet being placed in to the water of 15 ~ 25 ℃, in 3 minutes, can all disperse and pass through 24 mesh sieves.
11. according to the Pharmaceutical composition described in claim 1 ~ 4 and 8 ~ 9, it is characterized in that the described Cefdinir dispersible tablet dissolution of 15 minutes to be greater than 95%.
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| CN105168161A (en) * | 2015-11-02 | 2015-12-23 | 四川赛卓药业股份有限公司 | Cefdinir dispersible tablet and preparation method thereof |
| CN106333929A (en) * | 2016-09-24 | 2017-01-18 | 万特制药(海南)有限公司 | Agomelatine-containing dispersible tablet and preparation method thereof |
| CN112675137A (en) * | 2020-12-30 | 2021-04-20 | 苏州盛达药业有限公司 | Cefdinir bulk drug |
| CN114681414A (en) * | 2020-12-28 | 2022-07-01 | 北京新领先医药科技发展有限公司 | Cefdinir dispersible tablet pharmaceutical composition and preparation process thereof |
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| CN105168161A (en) * | 2015-11-02 | 2015-12-23 | 四川赛卓药业股份有限公司 | Cefdinir dispersible tablet and preparation method thereof |
| CN106333929A (en) * | 2016-09-24 | 2017-01-18 | 万特制药(海南)有限公司 | Agomelatine-containing dispersible tablet and preparation method thereof |
| CN114681414A (en) * | 2020-12-28 | 2022-07-01 | 北京新领先医药科技发展有限公司 | Cefdinir dispersible tablet pharmaceutical composition and preparation process thereof |
| CN112675137A (en) * | 2020-12-30 | 2021-04-20 | 苏州盛达药业有限公司 | Cefdinir bulk drug |
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