CN104622821B - Solve the problems, such as Moxifloxacin tablet formula of the dissolved corrosion by granulation time effects - Google Patents
Solve the problems, such as Moxifloxacin tablet formula of the dissolved corrosion by granulation time effects Download PDFInfo
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Abstract
The invention belongs to pharmaceutical technology field, specifically disclosing a kind of can effectively solve the problems, such as Moxifloxacin tablet formula of the dissolved corrosion by granulation time effects.Disintegrant is the mixing disintegrant being made up of the NF of Ac-Di-Sol SD 711 and PVPP XL in the formula, and mixing disintegrant accounts for the 3.0%~6.0% of total weight of tablet, and the wherein mass ratio of Ac-Di-Sol and PVPP is 2:1~5:1.Granulation time is almost on the dissolved corrosion of tablet obtained without influence after mixing disintegrant is added in the tablet formulation of the present invention.Therefore, technical scheme is more beneficial for industrialized production, and clinical application is safer effectively.
Description
Technical field
The present invention relates to pharmaceutical technology field, and in particular to one kind can effectively solve dissolved corrosion and be asked by granulation time effects
The Moxifloxacin tablet formula of topic.
Background technology
MOXIFLOXACIN（Moxifloxacin, Cas NO:151096-09-2）It is developed by German Bayer Medical Corporation
Four generation 8- methoxy fluoroquinolone class broad spectrum antibiotics, to gram-negative bacteria, gram positive bacteria, mycoplasma, Chlamydia and spinal cord
Scorching virus etc. is respectively provided with good antibacterial activity, is clinically used to treat soft group of infection in respiratory system, genital system infection, skin
Knit infection etc..MOXIFLOXACIN has excellent pharmacokinetic properties, and oral absorption is rapid, absolute bioavailability about 91%, blood
Slurry protein binding rate is low, and tissue penetration is strong, is not drained by Cytochrome P450 systemic metabolism, active compound through liver, kidney two-phase, no
The interaction of medicine easily occurs.MOXIFLOXACIN listed in Germany first in 1999, and December in the same year is in the U.S. with AveloxR zero
Trade name lists, and 2002 multiple to visit in ChinaListing.
German Baeyer medicine discloses the chemical constitution of MOXIFLOXACIN in CN1074218A and makees the purposes of antiseptic,
The pharmaceutical dosage form of MOXIFLOXACIN is disclosed in the patents such as CN1368891A, CN1325306A, wherein CN1325306A is finally disclosed
The oral formulations of MOXIFLOXACIN, by MOXIFLOXACIN or its salt, water stick, disintegrant, lubricant and 2.5%~25% lactose etc.
Composition.Although the technical scheme of the invention improves the hardness of tablet to a certain extent, we are studying the preparation work
Found during the committed step and critical process of skill, wherein granulation step is committed step, with the extension of Granulation time,
Dissolution rate can be reduced substantially, so Granulation time is the critical process factor in said preparation preparation process, it directly affects institute
The dissolved corrosion of preparation is obtained, so as to influence the release and absorption of medicine in vivo.Therefore, dissolution can effectively be solved by obtaining one kind
Behavior is very necessary by the Moxifloxacin tablet formula or method of granulation time effects problem.
The content of the invention
For the deficiencies in the prior art, solve dissolved corrosion object of the present invention is to provide one kind and pelletized
The Moxifloxacin tablet formula of time effects problem, the formula are obtained not by adding a certain amount of compound disintegrant
Granulation time length is not influenceed the dissolved corrosion of Xisha star tablet during by preparation completely.
It is well known that MOXIFLOXACIN poor fluidity, powder is poor, is not suitable for direct tablet compressing, can only pass through wet granulation work
Skill prepares tablet, and we have found to be used alone Ac-Di-Sol or PVPP as disintegrant, system after studying
The influence of the tablet dissolved corrosion to being obtained of grain time is more obvious, is replaced by Ac-Di-Sol and the poly- dimension of crosslinking
After ketone mixing disintegrant, Granulation time is almost on the dissolved corrosion of tablet obtained without influence.Therefore, using such scheme more
Be advantageous to industrialized production, clinical application is safer effectively.
Further, the present invention further defines Ac-Di-Sol and the preferable type of PVPP, mixing are collapsed
Solve the preferred content of agent, mix preferred proportion of Ac-Di-Sol and PVPP etc. in disintegrant.
Preferably, the model SD-711NF for mixing Ac-Di-Sol in disintegrant, PVPP
Model XL.
The mixing disintegrant accounts for 3.0%~6.0% of total weight of solids in tablet formulation, wherein cross-linked carboxymethyl cellulose
The mass ratio of sodium and PVPP is 2:1~5:1.
Preferably, the mixing disintegrant accounts for 4.0%~5.0% of total weight of solids in tablet formulation, wherein crosslinking carboxylic first
The mass ratio of base sodium cellulosate and PVPP is 3:1~4:1.
Optimal, the mixing disintegrant accounts for 4.5% of total weight of solids in tablet formulation, wherein cross-linked carboxymethyl fiber
The mass ratio of plain sodium and PVPP is 3.5：1.
Compared with prior art, the advantages of the present invention are：
By using mixing disintegrant in Tablets formula, and the particular type of mixing disintegrant is determined and contains
Amount, the dissolved corrosion of tablet obtained by making is reached completely not by the notable technique effect of granulation time effects.
Brief description of the drawings
Fig. 1-Fig. 3：The stripping curve figure of tablet made from embodiment 1-3, compound disintegrant content during embodiment 1-3 is formulated
For 3.5%, wherein Ac-Di-Sol SD-711NF is 2 with PVPP XL mass ratioes:1, Granulation time is respectively
120S、240S、360S；
Fig. 4-Fig. 6：The stripping curve figure of tablet made from embodiment 4-6, compound disintegrant content during embodiment 4-6 is formulated
For 5.5%, wherein Ac-Di-Sol SD-711NF is 5 with PVPP XL mass ratioes:1, Granulation time is respectively
120S、240S、360S；
Fig. 7-Fig. 9：The stripping curve figure of tablet made from embodiment 7-9, compound disintegrant content during embodiment 7-9 is formulated
For 4.5%, wherein Ac-Di-Sol SD-711NF is 3.5 with PVPP XL mass ratioes:1, Granulation time difference
For 120S, 240S, 360S；
Figure 10-Figure 12：The stripping curve figure of tablet made from comparative example 1-3, comparative example 1-3 are independent in being formulated
Using Ac-Di-Sol SD-711NF as disintegrant, Granulation time is respectively 120S, 240S, 360S；
Figure 13-Figure 15：The stripping curve figure of tablet made from comparative example 4-6, comparative example 4-6 are independent in being formulated
Using PVPP XL as disintegrant, Granulation time is respectively 120S, 240S, 360S.
Embodiment
Technical scheme is described in further detail with reference to specific embodiment.It should separately illustrate
It is that used supplementary material can be obtained commercially in following examples and comparative example.Wherein cross-linked carboxymethyl fiber
Plain sodium is medical auxiliary materials Technology Co., Ltd. purchased from upper Hydron, model SD-711NF；PVPP is doctor purchased from upper Hydron
Medicine auxiliary material Technology Co., Ltd., model XL；
Drug dissolution is evaluated
Dissolving-out method：Chinese Pharmacopoeia two methods of annex XC second of version in 2010
Slurry processes rotating speed：50 turns
Medium temperature：37±0.5℃
Assay method：UV-VIS spectrophotometry（Two A of annex IV of Chinese Pharmacopoeia version in 2010）
Computational methods：External standard method
Embodiment 1：A kind of Moxifloxacin tablet, its formula are as follows：
The step of preparation process of the Moxifloxacin tablet of above-mentioned formula composition is as follows：
(1) moxifloxacin hydrochloride, microcrystalline cellulose, lactose monohydrate, Ac-Di-Sol, PVPP are put
In wet granulator, turn on agitator mixing 90s, be then turned on clipper, be slowly added to purified water, set Granulation time as
120s, softwood is made.
(2) softwood obtained above is pelletized through 20 mesh sieves.
(3) obtained particle is dried 120 minutes under the conditions of 60 DEG C, through 18 mesh sieve whole grains.
(4) magnesium stearate lubricant is added into particle, is well mixed, tabletting produces after the assay was approved through intermediate.
Table 1：The stripping curve measurement result of tablet made from embodiment 1
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 55.3 | 76.5 | 88.4 | 95.8 | 99.1 |
Stripping curve is shown in Fig. 1.
Embodiment 2：A kind of Moxifloxacin tablet, formula composition completely with embodiment 1, preparation technology except setting pelletize when
Between be 240s beyond, remaining it is consistent with embodiment 1.
Table 2：The stripping curve measurement result of tablet made from embodiment 2
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 57.2 | 78.5 | 87.4 | 96.3 | 99.2 |
Stripping curve is shown in Fig. 2.
Embodiment 3：A kind of Moxifloxacin tablet, formula composition completely with embodiment 1, preparation technology except setting pelletize when
Between be 360s beyond, remaining it is consistent with embodiment 1.
Table 3：The stripping curve measurement result of tablet made from embodiment 3
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 54.2 | 75.8 | 86.9 | 97.1 | 98.5 |
Stripping curve is shown in Fig. 3.
Embodiment 4：A kind of Moxifloxacin tablet, its formula are as follows：
The step of preparation process of the Moxifloxacin tablet of above-mentioned formula is as follows：
(1) moxifloxacin hydrochloride, microcrystalline cellulose, lactose monohydrate, Ac-Di-Sol, PVPP are put
In wet granulator, turn on agitator mixing 90s, be then turned on clipper, be slowly added to purified water, set Granulation time as
120s, softwood is made.
(2) softwood obtained above is pelletized through 20 mesh sieves.
(3) obtained particle is dried 120 minutes under the conditions of 60 DEG C, through 18 mesh sieve whole grains.
(4) magnesium stearate lubricant is added into particle, is well mixed, tabletting produces after the assay was approved through intermediate.
Table 4：The stripping curve measurement result of tablet made from embodiment 4
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 51.5 | 73.5 | 82.7 | 94.6 | 98.9 |
Stripping curve is shown in Fig. 4.
Embodiment 5：A kind of Moxifloxacin tablet, formula composition completely with embodiment 4, preparation technology except setting pelletize when
Between be 240s beyond, remaining it is consistent with embodiment 4.
Table 5：The stripping curve measurement result of tablet made from embodiment 5
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 53.5 | 75.1 | 85.3 | 94.6 | 98.1 |
Stripping curve is shown in Fig. 5.
Embodiment 6：A kind of Moxifloxacin tablet, formula composition completely with embodiment 4, preparation technology except setting pelletize when
Between be 360s beyond, remaining it is consistent with embodiment 4.
Table 6：The stripping curve measurement result of tablet made from embodiment 6
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 56.3 | 72.8 | 87.9 | 98.3 | 98.8 |
Stripping curve is shown in Fig. 6.
Embodiment 7：A kind of Moxifloxacin tablet, its formula are as follows：
The step of preparation process of the Moxifloxacin tablet of above-mentioned formula is as follows：
(1) moxifloxacin hydrochloride, microcrystalline cellulose, lactose monohydrate, Ac-Di-Sol, PVPP are put
In wet granulator, turn on agitator mixing 90s, be then turned on clipper, be slowly added to purified water, set Granulation time as
120s, softwood is made.
(2) softwood obtained above is pelletized through 20 mesh sieves.
(3) obtained particle is dried 120 minutes under the conditions of 60 DEG C, through 18 mesh sieve whole grains.
(4) magnesium stearate lubricant is added into particle, is well mixed, tabletting produces after the assay was approved through intermediate.
Table 7：The stripping curve measurement result of tablet made from embodiment 7
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 65.8 | 80.3 | 90.7 | 95.6 | 99.3 |
Stripping curve is shown in Fig. 7.
Embodiment 8：A kind of Moxifloxacin tablet, formula composition completely with embodiment 7, preparation technology except setting pelletize when
Between be 240s beyond, remaining it is consistent with embodiment 7.
Table 8：The stripping curve measurement result of tablet made from embodiment 8
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 68.3 | 82.1 | 91.8 | 96.6 | 99.4 |
Stripping curve is shown in Fig. 8.
Embodiment 9：A kind of Moxifloxacin tablet, formula composition completely with embodiment 7, preparation technology except setting pelletize when
Between be 360s beyond, remaining it is consistent with embodiment 7.
Table 9：The stripping curve measurement result of tablet made from embodiment 9
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 66.5 | 83.1 | 92.9 | 98.3 | 100.2 |
Stripping curve is shown in Fig. 9.
Comparative example 1：A kind of Moxifloxacin tablet, its formula are as follows：
The step of preparation process of the Moxifloxacin tablet of above-mentioned formula is as follows：
(1) moxifloxacin hydrochloride, microcrystalline cellulose, lactose monohydrate, Ac-Di-Sol are placed in wet granulation
In machine, turn on agitator mixing 90s, clipper is then turned on, is slowly added to purified water, sets Granulation time as 120s, is made soft
Material.
(2) softwood obtained above is pelletized through 20 mesh sieves.
(3) obtained particle is dried 120 minutes under the conditions of 60 DEG C, through 18 mesh sieve whole grains.
(4) magnesium stearate lubricant is added into particle, is well mixed, tabletting produces after the assay was approved through intermediate.
Table 10：The stripping curve measurement result of tablet made from comparative example 1
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 45.8 | 70.2 | 80.1 | 90.1 | 95.3 |
Stripping curve is shown in Figure 10.
Comparative example 2：A kind of Moxifloxacin tablet, formula composition is completely with comparative example 1, and preparation technology is except setting
Granulation time is determined for beyond 240s, remaining is consistent with comparative example 1.
Table 11：The stripping curve measurement result of tablet made from comparative example 2
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 34.7 | 58.5 | 72.3 | 81.6 | 90.4 |
Stripping curve is shown in Figure 11.
Comparative example 3：A kind of Moxifloxacin tablet, formula composition is completely with comparative example 1, and preparation technology is except setting
Granulation time is determined for beyond 360s, remaining is consistent with comparative example 1.
Table 12：The stripping curve measurement result of tablet made from comparative example 3
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 26.6 | 53.1 | 68.9 | 76.8 | 85.1 |
Stripping curve is shown in Figure 12.
Comparative example 4：A kind of Moxifloxacin tablet, its formula are as follows：
The step of preparation process of the Moxifloxacin tablet of above-mentioned formula is as follows：
(1) moxifloxacin hydrochloride, microcrystalline cellulose, lactose monohydrate, PVPP are placed in wet granulator, opened
Agitator mixing 90s, is then turned on clipper, is slowly added to purified water, sets Granulation time as 120s, and softwood is made.
(2) softwood obtained above is pelletized through 20 mesh sieves.
(3) obtained particle is dried 120 minutes under the conditions of 60 DEG C, through 18 mesh sieve whole grains.
(4) magnesium stearate lubricant is added into particle, is well mixed, tabletting produces after the assay was approved through intermediate.
Table 13：The stripping curve measurement result of tablet made from comparative example 4
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 40.2 | 63.7 | 73.8 | 85.2 | 90.6 |
Stripping curve is shown in Figure 13.
Comparative example 5：A kind of Moxifloxacin tablet, formula composition is completely with comparative example 4, and preparation technology is except setting
Granulation time is determined for beyond 240s, remaining is consistent with comparative example 4.
Table 14：The stripping curve measurement result of tablet made from comparative example 5
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 30.1 | 52.5 | 62.1 | 77.4 | 86.5 |
Stripping curve is shown in Figure 14.
Comparative example 6：A kind of Moxifloxacin tablet, formula composition is completely with comparative example 4, and preparation technology is except setting
Granulation time is determined for beyond 360s, remaining is consistent with comparative example 4.
Table 15：The stripping curve measurement result of tablet made from comparative example 6
| Time（Minute） | 5 | 10 | 15 | 30 | 45 |
| Dissolution rate（%） | 22.9 | 46.8 | 60.8 | 70.8 | 80.3 |
Stripping curve is shown in Figure 15.
Claims (3)
1. a kind of solve the problems, such as Moxifloxacin tablet of the dissolved corrosion by granulation time effects, it is characterised in that：It is formulated composition
It is as follows：
The step of preparation process of the Moxifloxacin tablet of above-mentioned formula composition is as follows：
(1) moxifloxacin hydrochloride, microcrystalline cellulose, lactose monohydrate, Ac-Di-Sol, PVPP are placed in wet
In method granulator, turn on agitator mixing 90s, be then turned on clipper, be slowly added to purified water, set Granulation time as 120s or
240s or 360s, softwood is made；
(2) softwood obtained above is pelletized through 20 mesh sieves；
(3) obtained particle is dried 120 minutes under the conditions of 60 DEG C, through 18 mesh sieve whole grains；
(4) magnesium stearate lubricant is added into particle, is well mixed, through intermediate tabletting after the assay was approved, obtains Moses's sand
Star tablet.
2. a kind of solve the problems, such as Moxifloxacin tablet of the dissolved corrosion by granulation time effects, it is characterised in that：It is formulated composition
It is as follows：
The step of preparation process of the Moxifloxacin tablet of above-mentioned formula is as follows：
(1) moxifloxacin hydrochloride, microcrystalline cellulose, lactose monohydrate, Ac-Di-Sol, PVPP are placed in wet
In method granulator, turn on agitator mixing 90s, be then turned on clipper, be slowly added to purified water, set Granulation time as 120s or
240s or 360s, softwood is made；
(2) softwood obtained above is pelletized through 20 mesh sieves；
(3) obtained particle is dried 120 minutes under the conditions of 60 DEG C, through 18 mesh sieve whole grains；
(4) magnesium stearate lubricant is added into particle, is well mixed, through intermediate tabletting after the assay was approved, obtains Moses's sand
Star tablet.
3. a kind of solve the problems, such as Moxifloxacin tablet of the dissolved corrosion by granulation time effects, it is characterised in that：It is formulated composition
It is as follows：
The step of preparation process of the Moxifloxacin tablet of above-mentioned formula is as follows：
(1) moxifloxacin hydrochloride, microcrystalline cellulose, lactose monohydrate, Ac-Di-Sol, PVPP are placed in wet
In method granulator, turn on agitator mixing 90s, be then turned on clipper, be slowly added to purified water, set Granulation time as 120s or
240s or 360s, softwood is made；
(2) softwood obtained above is pelletized through 20 mesh sieves；
(3) obtained particle is dried 120 minutes under the conditions of 60 DEG C, through 18 mesh sieve whole grains；
(4) magnesium stearate lubricant is added into particle, is well mixed, through intermediate tabletting after the assay was approved, obtains Moses's sand
Star tablet.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102908323A (en) * | 2012-10-30 | 2013-02-06 | 天津红日药业股份有限公司 | Moxifloxacin-containing pharmaceutical composition |
| CN103284962A (en) * | 2012-02-23 | 2013-09-11 | 重庆圣华曦药业股份有限公司 | Moxifloxacin dispersible tablet and preparation method thereof |
| CN103301080A (en) * | 2012-03-15 | 2013-09-18 | 成都国为医药科技有限公司 | Moxifloxacin hydrochloride-containing pharmaceutical composition and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1663226A1 (en) * | 2003-09-03 | 2006-06-07 | Ranbaxy Laboratories Limited | Pharmaceutical compositions of moxifloxacin and processes for their preparation |
| ES2467105T5 (en) * | 2008-12-08 | 2017-12-05 | Ratiopharm Gmbh | Compacted moxifloxacin |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103284962A (en) * | 2012-02-23 | 2013-09-11 | 重庆圣华曦药业股份有限公司 | Moxifloxacin dispersible tablet and preparation method thereof |
| CN103301080A (en) * | 2012-03-15 | 2013-09-18 | 成都国为医药科技有限公司 | Moxifloxacin hydrochloride-containing pharmaceutical composition and preparation method thereof |
| CN102908323A (en) * | 2012-10-30 | 2013-02-06 | 天津红日药业股份有限公司 | Moxifloxacin-containing pharmaceutical composition |
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