CN105030717A - Moxifloxacin hydrochloride film-coated tablet and preparation method thereof - Google Patents
Moxifloxacin hydrochloride film-coated tablet and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a moxifloxacin hydrochloride film-coated tablet, which comprises the following components of moxifloxacin hydrochloride, pregelatinized starch, microcrystalline cellulose, croscarmellose sodium and magnesium stearate. The preparation method of a moxifloxacin hydrochloride preparation provided by the invention is simple in method, relatively few in pharmaceutical adjuvants, easy to operate and suitable for industrial production.
Description
Technical field
The present invention relates to pharmaceutical preparation, be specifically related to a kind of moxifloxacin hydrochloride Film coated tablets and preparation method thereof.
Background technology
Moxifloxacin (Moxifloxacin), Chinese another name 1-cyclopropyl-7-(S, S-2,8-diazabicyclo [4.3.0] nonane-8-base) the fluoro-8-methoxy of-6--4-oxo-1,4-dihydro-3-quinoline carboxylic acid, referred to as CDCH, be the complete synthesis antibacterials of fluorine quinoline quinolones broad spectrum activity of new generation.Be mainly used in treatment upper respiratory tract and lower respiratory infection clinically, as acute sinusitis, chronic bronchial acute attack, community acquired pneumonia, and Skin and soft tissue infection etc.
Moxifloxacin hydrochloride is the forth generation fluoroquinolones broad spectrum activity antimicrobial drug of German Bayer company research and development, and within 2002, Moxifloxacin hydrochloride tablet is in Discussion on Chinese Listed, and within 2005, moxifloxacin hydrochloride injection is in Discussion on Chinese Listed, trade name: visit multiple pleasure.
Bayer Bitterfeld GmbH medicine discloses the chemical constitution of Moxifloxacin and is used as the purposes of antibacterial in CN1074218A (application number is CN93100215.X), CN1368891A (application number is CN00811427.7), the pharmaceutical dosage form of Moxifloxacin is disclosed in the patents such as CN1325306A (application number is CN99813124.5), in CN1325306A, wherein disclose the oral formulations of Moxifloxacin, there are Moxifloxacin or its salt, 2-25% lactose, microcrystalline Cellulose, the oral drug preparation of sodium carboxymethyl cellulose and magnesium stearate, emphasize owing to employing lactose in prescription, Moxifloxacin tablet is made to have enough hardness and outstanding release.But the toleration of lactose is poor, be especially common in the crowd of intestinal lactase deficiency.The clinical symptoms such as abdominal cavity spasm, diarrhoea, abdominal distention and flatulence can be caused.
CN101890169A (application number is CN200910212686.X) discloses the oral drug preparation containing Moxifloxacin, its salt and/or its hydrate and soluble starch and pregelatinized Starch, it is mainly containing Moxifloxacin or its salt, waterless adhesive and disintegrating agent, lubricant and the soluble starch of 2.9-15.5% and the pregelatinized Starch of 1.4-6.5%, and the combination of mentioned component improves the dissolution of moxifloxacin hydrochloride.But soluble starch not yet has pharmaceutic adjuvant standard at present, the industrialization of product is thrown in has certain risk.
CN102600093B (application number is CN201210105923.4) discloses a kind of tablet of Moxifloxacin, and this tablet is primarily of Moxifloxacin or its salt, waterless adhesive, disintegrating agent and lubricant and a kind of mixing Hardening agent composition.Adopt the polyvidone of 10-25% pregelatinized Starch and 2-8%, tablet is made to have enough hardness and release as the agent of mixing Hardening, but the consumption of pregelatinized Starch in its prescription is 124mg, account for 18% of tablet weight, reached the upper limit about this adjuvant monolithic consumption in the adjuvant data base of State Food and Drug Administration's new drug approval center, the safety of life-time service medication has impact.
Moxifloxacin oral preparation commercially available is at present mainly tablet, Moxifloxacin poor fluidity, and powder is light, and water solublity is poor, is difficult to granulate, also increases the difficulty of tabletting.
Therefore, need to provide a kind of formula that can solve above-mentioned tabletting difficulty.
In prior art CN96123220.X, closely, difference is for the adjuvant of use and the present invention: the present invention's pregelatinized Starch substituted for the corn starch in the document, and the consumption of a lot of adjuvant is different from the present invention.
Pregelatinized Starch is its compressibility, good fluidity compared with common corn starch, has the character of bonding and disintegrate concurrently and is applicable to powder vertical compression, being therefore amylum pregelatinisatum again.Directly prepare starch slurry for not heating during wet granulation, therefore it directly can add in facility for granulating together with principal agent, other adjuvants, then adds water as wetting agent; It has self-lubricating function, and when can reduce tabletting, element sheet is from the frictional force of mold ejection, also can prevent the generation of taking off lid phenomenon simultaneously; In formulation study process, carried out comparative study to pregelatinized Starch and corn starch, pregelatinized Starch is compared corn starch and is had better compressibility, in tableting processes, corn starch has occurred taking off lid phenomenon, plain sheet friability is poor simultaneously, and hardness is also inadequate, is difficult to ensure the complete of coating.
4, the preparation method of moxifloxacin hydrochloride preparation provided by the invention, method is simple, and pharmaceutic adjuvant is less, is easy to operation, and Suitable commercial is produced.
Summary of the invention
In view of the above problems, the invention provides a kind of moxifloxacin hydrochloride Film coated tablets and preparation method thereof.
Moxifloxacin hydrochloride Film coated tablets provided by the invention, its plain sheet contains following composition: moxifloxacin hydrochloride, pregelatinized Starch, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose and magnesium stearate.
Concrete, the plain sheet of described Film coated tablets contains the composition of following weight portion: moxifloxacin hydrochloride 66-70 part, pregelatinized Starch 6-8 part, microcrystalline Cellulose 18-24 part, cross-linking sodium carboxymethyl cellulose 4-6 part and magnesium stearate 0.8-1.5 part.
Preferably, the plain sheet of described Film coated tablets contains the composition of following weight portion: moxifloxacin hydrochloride 67 parts, pregelatinized Starch 7 parts, microcrystalline Cellulose 20 parts, cross-linking sodium carboxymethyl cellulose 5 parts and magnesium stearate 1 part.
In Film coated tablets provided by the invention, it also comprises coating, and described bundle of clothes is water-soluble film clothing coating powder, and it accounts for 3% of plain sheet weight.
The present invention also provides the preparation method of described moxifloxacin hydrochloride Film coated tablets, and it is characterized in that, the method comprises the steps:
(1) supplementary material process: moxifloxacin hydrochloride is crossed 80 mesh sieves for subsequent use, it is for subsequent use that microcrystalline cellulose excipients, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose, magnesium stearate cross 80 mesh sieves respectively;
(2) wet mixing, granulation: take moxifloxacin hydrochloride, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose, magnesium stearate according to proportioning, then by moxifloxacin hydrochloride, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose mix homogeneously, add purified water, granulate, granulate, dry;
(3) tabletting: the dry granule that step (2) obtains is mixed with magnesium stearate, tabletting;
(4) coating: coating powder adds water, is mixed with the coating solution of 8%-10%, and in coating pan, temperature of charge controls all the time at 50-60 DEG C, and coating to obtain final product.
In said method: the consumption of the purified water in described step (2) is 1.5-3 times of volume of microcrystalline Cellulose weight, and as microcrystalline Cellulose consumption 10g, then the consumption of purified water is 15-30ml.
Moxifloxacin hydrochloride Film coated tablets provided by the invention and preparation technology thereof have the following advantages:
1, form: the poor and light weight of moxifloxacin hydrochloride mobility, when being prepared into preparation, be not easy tabletting, the present invention has selected in following composition:
Cross-linking sodium carboxymethyl cellulose: when investigating for disintegrating agent kind, selects during cross-linking sodium carboxymethyl cellulose and the disintegration time of this tablet can be controlled within 2min., find when study on the stability, the stability of adding the sample of cross-linking sodium carboxymethyl cellulose is better meanwhile, its disintegration and releasing effect can not because of time and become.
Pregelatinized Starch, belongs to modified starch, compares starch and has better compressibility; When tablet forming technique is groped, contrast with starch and investigate, the sample friability of starch is higher and there will be sticking phenomenon in process, simultaneously suppress about 0.7g and the Special-shaped sheet of larger flap-type time, the hardness of element sheet need ensure the integrity of flap-type in coating process, so select the good pregelatinized Starch of compressibility to be very necessary when prescription is investigated at least more than 180N.In addition, pregelatinized Starch not only has the effect of filler, the suitable effect having binding agent concurrently of the ratio used in wet granulation; From preparation process, pregelatinized Starch and the ratio of microcrystalline Cellulose in prescription consumption are at about 1:3, and pregelatinized Starch is more the effect of filler.From dissolved corrosion, when selecting pregelatinized Starch, 15min dissolution is more than 85%; Pregelatinized Starch and microcrystalline Cellulose ratio are when about 1:3, and disintegration of tablet time limit and dissolution all present good effect.
Microcrystalline Cellulose is waterless adhesive, is conventional pharmaceutic adjuvant.
2, preparation technology:
In process, according to the physicochemical property of moxifloxacin hydrochloride itself, the poor and feature of light weight of its mobility, when adopting boiling granulating method, raw material easily sticks at ebullated bed inwall and trembles on bag, is unfavorable for very much Homogeneous phase mixing between supplementary material; But when adopting wet granulation, during premix, supplementary material gets final product mix homogeneously, improves the mobility of raw material preferably, be more convenient to tabletting after granulation.
In preparation process, during granulation, the amount needs adding water control about 40%, there will be the phenomenon of granule comparatively large comparatively hard or granule less one-tenth fine powder time more or less; During tabletting, the hardness of plain sheet need be ensured with larger pressure, once hardness is lower, during coating, then there will be the phenomenons such as sheet surface wear, pitted skin.
Inventor finds when choice for use pregelatinized Starch and microcrystalline Cellulose after large quantity research, during preparation Moxifloxacin tablet, there occurs beat all effect.
3, compared with prior art:
Detailed description of the invention
Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.
Embodiment 1: moxifloxacin hydrochloride Film coated tablets
1, form: this Film coated tablets counts by weight percentage, and 1000 (tablet calculates based on non-coating) its prescriptions are as follows:
2, preparation technology:
(1) 80 mesh sieves are crossed in supplementary material process;
(2) wet mixing, granulation: the moxifloxacin hydrochloride after sieving, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose drop in wet granulator and stir high-speed stirred, add the purified water of microcrystalline Cellulose recipe quantity 2 times of volumes, adopt oscillating granulator 20 eye mesh screen wet granular, wet granular is dried to moisture in heated-air circulation oven 55 DEG C and is less than 3%;
(3) tabletting: dry granule with add the magnesium stearate of having sieved simultaneously and mix, drop into movement mixer mixing, according to the average sheet weight of midbody particle cubage, control tablet weight variation ± 5%;
(4) coating: added water by coating, is mixed with the coating solution of 8%, and in coating pan, temperature of charge controls all the time at 55 DEG C.
Embodiment 2: moxifloxacin hydrochloride Film coated tablets
1, form: this Film coated tablets counts by weight percentage, and 1000 (tablet calculates based on non-coating) its prescriptions are as follows:
2, preparation technology:
(1) 80 mesh sieves are crossed in supplementary material process;
(2) wet mixing, granulation: the moxifloxacin hydrochloride after sieving, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose drop in wet granulator and stir high-speed stirred, add the purified water of microcrystalline Cellulose recipe quantity 2 times of volumes, adopt oscillating granulator 20 eye mesh screen wet granular, wet granular is dried to moisture in heated-air circulation oven 50 DEG C and is less than 4%;
(3) tabletting: dry granule with add the magnesium stearate of having sieved simultaneously and mix, drop into movement mixer mixing, according to the average sheet weight of midbody particle cubage, control tablet weight variation ± 5%;
(4) coating: coating adds water, is mixed with the coating solution of 10%, and in coating pan, temperature of charge controls all the time at 50 DEG C.
Embodiment 3: moxifloxacin hydrochloride Film coated tablets
1, form: this Film coated tablets counts by weight percentage, and 1000 (tablet calculates based on non-coating) its prescriptions are as follows:
2, preparation technology:
(1) 80 mesh sieves are crossed in supplementary material process;
(2) wet mixing, granulation: the moxifloxacin hydrochloride after sieving, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose drop in wet granulator and stir high-speed stirred, add the purified water of microcrystalline Cellulose recipe quantity 2 times of volumes, adopt oscillating granulator 20 eye mesh screen wet granular, wet granular is dried to moisture in heated-air circulation oven 60 DEG C and is less than 2%;
(3) tabletting: dry granule with add the magnesium stearate of having sieved simultaneously and mix, drop into movement mixer mixing, according to the average sheet weight of midbody particle cubage, control tablet weight variation ± 5%;
(4) coating: coating adds water, is mixed with the coating solution of 10%, and in coating pan, temperature of charge controls all the time at 60 DEG C.
Comparative example 1
1, form: prepare Moxifloxacin tablet 1000 (tablet calculates based on non-coating) by comparative example CN201210105923.4 (embodiment 3):
2, the concrete steps of Moxifloxacin tablet preparation method are as follows:
1) get above-mentioned moxifloxacin hydrochloride, Hardening agent pregelatinized Starch, waterless adhesive microcrystalline Cellulose, in the cross-linking sodium carboxymethyl cellulose that adds and Hardening agent mannitol be dry mixed;
2) 5% PVP K30 solution is joined step 1) in the mixture of gained, mix homogeneously;
3) 80 DEG C of dryings, 18 mesh sieve granulate, add magnesium stearate and silicon dioxide, additional cross-linking sodium carboxymethyl cellulose in lubricant, mix homogeneously, and intermediate detects qualified rear tabletting, to obtain final product.
Comparative example 2:
With reference to the embodiment 7 of CN96123220.X, specifically see the following form:
| Weight | Percentage ratio (%) | |
| Moxifloxacin hydrochloride | 25.1g | 82.84 |
| Corn starch | 1.7g | 5.61 |
| Microcrystalline Cellulose (Avicel PH 101) | 3.3g | 10.89 |
| Cross-linking sodium carboxymethyl cellulose (Ac-Di-Sol) | 0.19g | 0.63 |
| Magnesium stearate | 0.01g | 0.03 |
| Add up to | 30.3g | 100 |
Its preparation method adopts the method preparation of CN96123220.X, then coating (materials of coating and consumption are with embodiments of the invention 1).
Comparative example 3: the starch (namely using soluble starch and pregelatinized Starch) in the formula of reference example 1 and CN101890169A prepares Moxifloxacin tablet 1000 (tablet calculates based on non-coating)
| Weight | Percentage ratio (%) | |
| Moxifloxacin hydrochloride | 436.4g | 67 |
| Soluble starch | 31.9g | 5 |
| Pregelatinized Starch | 13.7g | 2 |
| Microcrystalline Cellulose | 130.2g | 20 |
| Cross-linking sodium carboxymethyl cellulose | 32.6g | 5 |
| Magnesium stearate | 6.5g | 1 |
| Add up to | 651.3g | 100 |
Its preparation method adopts the method preparation of embodiment 1.
Measure embodiment 1: the hardness evaluation of tablet
1, by the sample obtained by embodiment 1,2,3 and comparative example, under the uniform pressure of tablet machine 10KN, obtained slice, thin piece hardness tester measures hardness, and the hardness during element sheet fracture of record Moxifloxacin sheet, in units of N.
2, each group tablet hardness situation comparative result: in table 1.
Table 1: each group tablet hardness situation
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 | Comparative example 3 | |
| Element sheet hardness (N) | 200 | 210 | 200 | 160 | 150 | 170 |
| Friability (%) | 0.10 | 0.11 | 0.10 | 0.18 | 0.20 | 0.15 |
Shown by table 1 result: under the pressure being all 10KN, the preparation hardness of embodiment 1 is 200N, and comparative example is 160N, 150N and 170N.
Result shows, preparation provided by the invention tablet hardness is at the same pressure higher than three comparative example.
Measure embodiment 2: study on the stability
Accelerated test (40 DEG C ± 2 DEG C, RH75% ± 5%), concrete test method is in table 2:
Table 2: accelerated test method
| Investigation project | Method and limit (requirement) |
| Character | Range estimation (Film coated tablets, aobvious faint yellow or yellow after removing coating) |
| Disintegration | CP2010 version two annex Ⅹ A |
| Dissolution | CP2010 version two annex Ⅹ C second methods (limit is 85% of labelled amount) |
| Moisture | Conventional method (must not 6.0% be crossed) |
| Assay | HPLC method (should be 95.0% ~ 105.0% of labelled amount) |
Sample is obtained to embodiment 1-3 and carries out accelerated test investigation, in Table 3-5:
Table 3: embodiment 1 sample accelerated test investigates situation
Table 4: embodiment 2 sample accelerated test investigates situation
Table 5: embodiment 3 sample accelerated test investigates situation
Result shows, preparation provided by the invention, and the tablet stability under accelerated test environment is fine.
Measure embodiment 3: the Dissolution Evaluation of tablet
1, dissolving-out method: Chinese Pharmacopoeia 2010 editions two annex XC second methods
Rotating speed: 50 revs/min;
Dissolution medium: 0.1mol/L hydrochloric acid 900ml;
Get this product, often criticize 6, carry out stripping curve mensuration as stated above, respectively through 5,10,15,30,45 minutes time, get dissolution fluid 10ml, filter through 0.45 μm of filter membrane, add equivalent equality of temperature solvent simultaneously.
2, assay method: precision measures subsequent filtrate 1ml, puts in 20ml volumetric flask, is diluted to scale with dissolution medium, shake up, as need testing solution; Separately get Moxifloxacin reference substance appropriate, add stripping medium dissolves and make the solution about containing 20 μ g Moxifloxacin in every 1ml, product solution in contrast.Get need testing solution and reference substance solution respectively, according to ultraviolet visible spectrophotometry (Chinese Pharmacopoeia version in 2010 two annex IV A), measure absorbance at 324nm wavelength place, calculate dissolution and draw accumulation stripping curve.
3, record result, mapping is compared, and the time the results are shown in Table 6.
Table 6: stripping situation
| Time (min) | Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
| 5 | 84 | 79 | 82 | 80 | 83 | 80 |
| 10 | 97 | 95 | 97 | 93 | 91 | 91 |
| 15 | 99 | 98 | 98 | 96 | 95 | 95 |
| 30 | 99 | 99 | 99 | 99 | 98 | 99 |
| 45 | 100 | 99 | 99 | 99 | 99 | 99 |
| 60 | 100 | 100 | 100 | 100 | 99 | 100 |
Shown by table 6 result: the accumulative releasing degree under same time, be better than preparation prepared by comparative example disclosure method, prescription is more simple simultaneously.Such as 15 minutes time, the preparation of embodiment 1 adds up release 99%, and comparative example is 96%.
Result shows: from dissolved corrosion, and pregelatinized Starch and microcrystalline Cellulose ratio are when about 1:3, and disintegration of tablet time limit and dissolution all present good effect.The preparation method of moxifloxacin hydrochloride preparation provided by the invention, method is simple, and pharmaceutic adjuvant is less, is easy to operation, and Suitable commercial is produced.
Although above with general explanation, detailed description of the invention and test, the present invention is described in detail, and on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (9)
1. a moxifloxacin hydrochloride Film coated tablets, its plain sheet contains following composition: moxifloxacin hydrochloride, pregelatinized Starch, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose and magnesium stearate.
2. Film coated tablets according to claim 1, it is characterized in that, the plain sheet of described Film coated tablets contains the composition of following weight portion: moxifloxacin hydrochloride 66-70 part, pregelatinized Starch 6-8 part, microcrystalline Cellulose 18-24 part, cross-linking sodium carboxymethyl cellulose 4-6 part and magnesium stearate 0.8-1.5 part.
3. Film coated tablets according to claim 2, it is characterized in that, the plain sheet of described Film coated tablets contains the composition of following weight portion: moxifloxacin hydrochloride 67 parts, pregelatinized Starch 7 parts, microcrystalline Cellulose 20 parts, cross-linking sodium carboxymethyl cellulose 5 parts and magnesium stearate 1 part.
4. Film coated tablets according to claim 2, it is characterized in that, the plain sheet of described Film coated tablets contains the composition of following weight portion: moxifloxacin hydrochloride 66 parts, pregelatinized Starch 8 parts, microcrystalline Cellulose 21 parts, cross-linking sodium carboxymethyl cellulose 4 parts and magnesium stearate 1 part.
5. Film coated tablets according to claim 2, it is characterized in that, the plain sheet of described Film coated tablets contains the composition of following weight portion: moxifloxacin hydrochloride 70 parts, pregelatinized Starch 6 parts, microcrystalline Cellulose 18 parts, cross-linking sodium carboxymethyl cellulose 5 parts and magnesium stearate 1 part.
6. the Film coated tablets according to any one of claim 1-5, is characterized in that, also comprises coating.
7. Film coated tablets according to claim 6, is characterized in that, described coating is water-soluble film clothing coating powder.
8. prepare the method for the Film coated tablets described in any one of claim 1-7, it is characterized in that, the method comprises the steps:
(1) supplementary material process: moxifloxacin hydrochloride is crossed 80 mesh sieves for subsequent use, it is for subsequent use that microcrystalline cellulose excipients, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose, magnesium stearate cross 80 mesh sieves respectively;
(2) wet mixing, granulation: take moxifloxacin hydrochloride, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose, magnesium stearate according to proportioning, then moxifloxacin hydrochloride, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose are put mix homogeneously in method using fast wet granulator, add purified water, wet granular is made through 20 mesh sieves, drying, then through 20 mesh sieve granulate;
(3) always mix: the dry granule that step (2) obtains is mixed homogeneously with magnesium stearate;
(4) tabletting: according to after the total mixed granule content calculating sheet weight that step (3) obtains, carry out continuous tabletting;
(5) coating: coating adds water, is mixed with the coating solution of 8%-10%, and in coating pan, temperature of charge controls all the time at 50-60 DEG C, between coating weight gain 2.0 ~ 3.0%, and slice and get final product.
9. the application of the Film coated tablets described in any one of claim 1-7 in the medicine that preparation is antibacterial.
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| CN113499316A (en) * | 2021-07-12 | 2021-10-15 | 湖南天济草堂制药股份有限公司 | Preparation method of moxifloxacin hydrochloride tablets |
| CN113750067A (en) * | 2021-08-25 | 2021-12-07 | 海南海灵化学制药有限公司 | Preparation process of levofloxacin tablets |
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| CN109045034A (en) * | 2018-09-29 | 2018-12-21 | 哈尔滨珍宝制药有限公司 | A kind of moxifloxacin hydrochloride medicinal composition and its preparation method and application |
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| CN113750067A (en) * | 2021-08-25 | 2021-12-07 | 海南海灵化学制药有限公司 | Preparation process of levofloxacin tablets |
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Application publication date: 20151111 |