CN103040778A - Azithromycin dispersible tablet, as well as preparation method and application thereof - Google Patents
Azithromycin dispersible tablet, as well as preparation method and application thereof Download PDFInfo
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- CN103040778A CN103040778A CN2012105902402A CN201210590240A CN103040778A CN 103040778 A CN103040778 A CN 103040778A CN 2012105902402 A CN2012105902402 A CN 2012105902402A CN 201210590240 A CN201210590240 A CN 201210590240A CN 103040778 A CN103040778 A CN 103040778A
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Abstract
The invention provides an azithromycin dispersible tablet which is a preparation prepared from the following raw materials by weight: 10-16 parts of micro-powder silicon gel, 60-120 parts of microcrystalline cellulose, 20-40 parts of low substituted hydroxy propyl cellulose, 8-15 parts of tablet lubricant and 0-50 parts of filler, wherein the filler is one or combination of more than two of lactose, pregelatinized starch, starch, dextrin, mannitol, powdered sugar and calcium carbonate. The invention further provides a preparation method and an application of the dispersible tablet. Through a great deal of experimental research on dispersible tablet recipes, an azithromycin dispersible tablet recipe applicable to the mode that powder is directly pressed into tablets is ultimately found, so that not only are phenomena of sticking, crack, uncovering and the like in the process that the azithromycin powder is directly pressed into tablets solved, but also dispersible tablets with good properties of uniform dispersion, dissolution rate and the like are obtained; and meanwhile the dispersible table ensures the stability of a main medicine, avoids degradation of the main medicine and provides safer choice for clinical medication.
Description
Technical field
The present invention relates to a kind of Azithromycin dispersible tablet and its production and use.
Background technology
Azithromycin belongs to macrolide antibiotics, has unique pharmacokinetic characteristics, and biological half-life is long, and tissue permeability is high, and chemistry and biological stability are good, has a broad antifungal spectrum, and untoward reaction is little, the advantages such as better tolerance.Be widely used in clinically respiratory tract, skin soft tissue and urogenital infections.This kind dosage form of present domestic listing includes ordinary tablet, dispersible tablet, capsule, granule, dry suspension etc.
Because the azithromycin poorly water-soluble, ordinary tablet stripping and absorption in vivo is greatly affected.Dispersible tablet is a kind of novel quick-effective preparation that in recent years develops rapidly, both can directly take, also but rapid dispersion is drunk after in water, it is slow that the appearance of this dosage form has solved the solid preparation disintegrate, stripping is poor, the problems such as bioavailability is not high are particularly suitable for the medicine that infection, antipyretic-antalgic etc. need quick acting." clear and definite definition and requirement are arranged in the Chinese pharmacopoeia, and " dispersible tablet means can rapid disintegrate and homodisperse tablet in water version in 2010 for this dosage form.Medicine in the dispersible tablet should be indissoluble.Dispersible tablet can add after the aqueous dispersion oral, also dispersible tablet can be contained in to suck clothes in the mouth or swallow.
At present existing research worker is prepared into the dispersion sheet with azithromycin, has obtained good therapeutic effect.Yet, there is following problem in the Azithromycin dispersible tablet of listing: existing Azithromycin dispersible tablet preparation method all is tablettings behind the wet granulation, but azithromycin is macrolide antibiotics, unstable under wet heat condition, inevitably can be exposed in the hygrothermal environment in the wet-granulation process, principal agent can be degraded, and related substance can obviously increase, so that may there be certain potential safety hazard in medicine.
If can adopt the method for powder formulation tabletting to prepare dispersible tablet, then can address the above problem.But the inventor studies discovery, because the compressibility of azithromycin own is relatively poor, and has viscosity, is easy to cause sticking in the process of carrying out tabletting, sliver, and the problem such as friability is defective, this phenomenon more highlights when adopting technique of direct powder compression.
Summary of the invention
For defects, the object of the present invention is to provide a kind of Azithromycin dispersible tablet that is suitable for direct pressed powder, and the preparation method of Azithromycin dispersible tablet and purposes.
The invention provides a kind of Azithromycin dispersible tablet, it is the preparation that the supplementary material by following weight proportion is prepared from:
250 parts of azithromycins;
10 ~ 16 parts of micropowder silica gels, 60 ~ 120 parts of microcrystalline Cellulose, with lubricator 8 ~ 15 parts of 20 ~ 40 parts of low-substituted hydroxypropyl celluloses, tablet, 0 ~ 50 part of filler; Described filler is one or more the combination in lactose, pregelatinized Starch, starch, dextrin, mannitol, Icing Sugar, the calcium carbonate.
Further, described micropowder silica gel is 12 ~ 16 parts, and low-substituted hydroxypropyl cellulose is 25 ~ 40 parts.
Further, described microcrystalline Cellulose is 70 ~ 120 parts.
Further, described filler is that lactose is or/and pregelatinized Starch; Described tablet with lubricator is one or more the combination in magnesium stearate, sodium stearyl fumarate, Pulvis Talci, the glyceryl monostearate.
Further preferably, it is the preparation that the supplementary material by following weight proportion is prepared from:
250 parts of azithromycins;
12 ~ 14 parts of micropowder silica gels, 70 ~ 90 parts of microcrystalline Cellulose, with lubricator 8 ~ 10 parts of 25 ~ 40 parts of low-substituted hydroxypropyl celluloses, tablet, 30 ~ 50 parts of filleies; Wherein, tablet with lubricator is magnesium stearate, and filler is lactose.
Further preferably, it is the preparation that the supplementary material by following weight proportion is prepared from:
250 parts of azithromycins, 14 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 10 parts of magnesium stearate;
Or, 250 parts of azithromycins, 16 parts of micropowder silica gels, 110 parts of microcrystalline Cellulose, 20 parts of lactose, pregelatinized Starch 20 minutes, 25 parts of low-substituted hydroxypropyl celluloses, 15 parts of magnesium stearate;
Or, 250 parts of azithromycins, 14 parts of micropowder silica gels, 80 parts of microcrystalline Cellulose, 40 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 10 parts of magnesium stearate;
Or, 250 parts of azithromycins, 12 parts of micropowder silica gels, 70 parts of microcrystalline Cellulose, 50 parts of lactose, 40 parts of low-substituted hydroxypropyl celluloses, 8 parts of magnesium stearate;
Or, 250 parts of azithromycins, 15 parts of micropowder silica gels, 120 parts of microcrystalline Cellulose, 40 parts of low-substituted hydroxypropyl celluloses, 8 parts of magnesium stearate;
Or, 250 parts of azithromycins, 16 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 15 parts of Pulvis Talci;
Or, 250 parts of azithromycins, 14 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 5 parts of magnesium stearate, 10 parts of Pulvis Talci;
Or, 250 parts of azithromycins, 14 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 15 parts of sodium stearyl fumarates;
Or, 250 parts of azithromycins, 16 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 15 parts of glyceryl monostearate.
Wherein, described adjuvant also comprises 1-3 part correctives.
Further, described correctives is aspartame, steviosin, saccharin sodium or sucralose.
The present invention also provides the preparation method of above-mentioned Azithromycin dispersible tablet, and it comprises following operating procedure:
(1) takes by weighing by weight ratio supplementary material;
(2) get other supplementary materials except magnesium stearate, sieve, behind the mixing, add the magnesium stearate mix homogeneously again, direct compression namely gets dispersible tablet.
Further, the concrete operations of step (2) are as follows:
A, get azithromycin and micropowder silica gel, mixed 80 ~ 100 mesh sieves, mix homogeneously gets powder a;
B, get other adjuvants except magnesium stearate and micropowder silica gel, mix homogeneously gets powder b;
C, powder a, b are crossed 40 ~ 60 mesh sieves, behind the mix homogeneously, add magnesium stearate again and mix, incorporation time is in 30min, and gained mixed-powder direct compression namely gets dispersible tablet.
Further, among the step C, incorporation time is 5 ~ 30min after the adding magnesium stearate.
The present invention is by the lot of experiments research to the dispersible tablet prescription, finally obtained the Azithromycin dispersible tablet prescription of suitable direct powder compression, not only solve sticking, sliver that azithromycin occurs in the direct powder compression process, taken off the phenomenons such as lid, obtained being uniformly dispersed, the well behaved dispersible tablet such as dissolution, simultaneously, the gained dispersible tablet has guaranteed the stability of principal agent, has avoided the degraded of principal agent, for clinical application provides safer selection.
The specific embodiment
The preparation method of embodiment 1 Azithromycin dispersible tablet of the present invention
[prescription]
Preparation method:
1, gets azithromycin and mixed 80 mesh sieves, mix homogeneously with micropowder silica gel;
2, with lactose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, aspartame mix homogeneously;
3, above two kinds of powder are crossed 60 mesh sieves, behind the mix homogeneously, add magnesium stearate and in mixer, mix 5-10min;
4, regulate tablet machine pressure and sheet and weigh, get above-mentioned mixed powder and carry out tabletting, namely get 1000 dispersible tablets.
The present invention can also use sucrose, steviosin, saccharin sodium, sucralose, edible essence and their compositions etc. except using aspartame as the correctives.
The preparation method of embodiment 2 Azithromycin dispersible tablets of the present invention
Prescription and preparation method according to embodiment 1 prepare dispersible tablet, and wherein step 1,3 the whole incorporation time of crossing grit number and step 3 are with reference to following table, and the result is as follows for the gained dispersible tablet:
Table 1
By the above results as can be known, after incorporation time reached 30min, slice, thin piece hardness significantly descended, and in order to guarantee the concordance of product quality, the present invention is incorporation time 5-30min preferably.
It is preferred that embodiment 3 Azithromycin dispersible tablets of the present invention are write out a prescription
Because the compressibility of azithromycin own is relatively poor, and has viscosity, in the process of carrying out tabletting, be easy to cause sticking, sliver, the problem such as friability is defective, this phenomenon more highlights when adopting technique of direct powder compression.
In order to obtain the Azithromycin dispersible tablet of high-quality, the present invention screens the dispersible tablet prescription, and wherein, prescription proportioning and incorporation time are all according to table 2, and preparation method is with reference to embodiment 1.
Table 2
Table 2 is continuous
Brief summary:
(1) by the prescription 1-13 more as can be known, if the prescription in do not add micropowder silica gel, then dispersible tablet sticking phenomenon is comparatively obvious; If adopt pregelatinized Starch and cross-linking sodium carboxymethyl cellulose in the prescription, replace lactose and low-substituted hydroxypropyl cellulose, the easy sliver of dispersible tablet then, friability is undesirable;
By the screening to supplementary product kind, the supplementary product kind that the present invention finally determines is: micropowder silica gel, microcrystalline Cellulose, lactose, low-substituted hydroxypropyl cellulose, magnesium stearate, and an amount of correctives and pregelatinized Starch, finally obtain substantially qualified dispersible tablet supplementary material proportioning and be:
250 parts of azithromycins; 10 ~ 16 parts of micropowder silica gels, 60 ~ 120 parts of microcrystalline Cellulose, with lubricator 8 ~ 15 parts of 20 ~ 40 parts of low-substituted hydroxypropyl celluloses, tablet, 0 ~ 50 part of filler.
(2) by writing out a prescription 2-4,7-18 more as can be known, even if selected supplementary product kind, but different supplementary product consumptions still plays crucial impact to the performance of dispersible tablet, wherein, dispersible tablet under the 2 supplementary product consumption proportionings of writing out a prescription, disintegration is longer, and dispersing uniformity and dissolution are relatively poor; The dispersed homogeneous degree of 3 adjuvants of writing out a prescription is general; The features such as dissolution of prescription 11 are qualified, but disintegration is longer, surpass 1min.Therefore, the present invention determines that standard compliant dispersible tablet supplementary material proportioning is:
250 parts of azithromycins; 12 ~ 16 parts of micropowder silica gels, 60 ~ 120 parts of microcrystalline Cellulose, with lubricator 8 ~ 15 parts of 25 ~ 40 parts of low-substituted hydroxypropyl celluloses, tablet, 0 ~ 50 part of filler.
(3) in order further to improve the dissolution (more than 90%) of dispersible tablet, the present invention can be preferably as follows the supplementary material proportioning:
250 parts of azithromycins; 12 ~ 16 parts of micropowder silica gels, 70 ~ 120 parts of microcrystalline Cellulose, with lubricator 8 ~ 15 parts of 25 ~ 40 parts of low-substituted hydroxypropyl celluloses, tablet, 0 ~ 50 part of filler.
(4) in order to guarantee dissolution more than 90%, can further reduce again the friability of tablet, guarantee intact in transportation, storage of tablet, the present invention finally also is preferably as follows the supplementary material proportioning:
250 parts of azithromycins; 12 ~ 14 parts of micropowder silica gels, 70 ~ 90 parts of microcrystalline Cellulose, with lubricator 8 ~ 10 parts of 25 ~ 40 parts of low-substituted hydroxypropyl celluloses, tablet, 30 ~ 50 parts of filleies; Wherein, tablet with lubricator is magnesium stearate, and filler is lactose.
Below specify beneficial effect of the present invention by test example.
The tablet properties of test example 1 Azithromycin dispersible tablet of the present invention is measured
By " 2010 editions correlation techniques of Chinese pharmacopoeia are measured dissolution, friability, disintegration and the dispersing uniformity of Azithromycin dispersible tablet of the present invention (embodiment 1 preparation).The result is referring to table 3,4.
Table 3 Azithromycin dispersible tablet dissolution of the present invention (%) testing result (n=6)
| The sample name | 3min | 10min |
| Embodiment 1 sample 1 | 93.2 | 99.7 |
| Embodiment 1 sample 2 | 94.3 | 99.5 |
| Embodiment 1 sample 3 | 92.7 | 100.3 |
Other testing results of table 4 Azithromycin dispersible tablet of the present invention (n=6)
| The sample name | Embodiment 1 sample 1 | Embodiment 1 sample 2 | Embodiment 1 sample 3 |
| Friability | 0.13% | 0.15% | 0.11% |
| Disintegration | 25s | 30s | 27s |
| Dispersing uniformity | Up to specification (＜1min) | Up to specification (＜1min) | Up to specification (＜1min) |
By the above results as can be known, the Azithromycin dispersible tablet of the present invention's preparation, overcome sticking, sliver that azithromycin occurs in the direct powder compression process, taken off the problems such as lid, prepared all good dispersible tablets of dissolution, friability, disintegration and dispersing uniformity.
Test example 2 Azithromycin dispersible tablets of the present invention are on the impact of raw material degraded
By " 2010 editions correlation techniques of Chinese pharmacopoeia are measured its related substances in Azithromycin dispersible tablet of the present invention (embodiment 1 preparation) and the Azithromycin Raw Material, whether raw material are caused degraded in order to the preparation of determining dispersible tablet of the present invention.The results are shown in Table 5.
Table 5 Azithromycin Raw Material and dispersible tablet related substance testing result
| The sample name | Maximum is the assorted % of notice of invitation not | Total assorted % |
| Raw material | 0.54 | 2.58 |
| Embodiment 1 sample 1 | 0.55 | 2.57 |
| Embodiment 1 sample 2 | 0.54 | 2.58 |
| Embodiment 1 sample 3 | 0.55 | 2.58 |
By the above results as can be known, in the dispersible tablet finished product of the present invention, its related substances and raw material are consistent, and namely show, in the preparation process, it is stable that the principal agent composition keeps, and degraded do not occur.
The present invention is by the lot of experiments research to the dispersible tablet prescription, finally obtained the Azithromycin dispersible tablet prescription of suitable direct powder compression, not only solve sticking, sliver that azithromycin occurs in the direct powder compression process, taken off the phenomenons such as lid, obtained being uniformly dispersed, the well behaved dispersible tablet such as dissolution, simultaneously, the gained dispersible tablet has guaranteed the stability of principal agent, has avoided the degraded of principal agent, for clinical application provides safer selection.
In addition, compare with existing wet granule compression tablet, the present invention does not adopt binding agent granulation, drying, has saved operation and energy consumption, has reduced the CCP in the whole technique, has reduced the difficulty of quality control.
Claims (10)
1. Azithromycin dispersible tablet is characterized in that: it is the preparation that the supplementary material by following weight proportion is prepared from:
250 parts of azithromycins;
10 ~ 16 parts of micropowder silica gels, 60 ~ 120 parts of microcrystalline Cellulose, with lubricator 8 ~ 15 parts of 20 ~ 40 parts of low-substituted hydroxypropyl celluloses, tablet, 0 ~ 50 part of filler; Described filler is one or more the combination in lactose, pregelatinized Starch, starch, dextrin, mannitol, Icing Sugar, the calcium carbonate.
2. Azithromycin dispersible tablet according to claim 1, it is characterized in that: described micropowder silica gel is 12 ~ 16 parts, low-substituted hydroxypropyl cellulose is 25 ~ 40 parts.
3. Azithromycin dispersible tablet according to claim 1 and 2, it is characterized in that: described microcrystalline Cellulose is 70 ~ 120 parts.
4. the described Azithromycin dispersible tablet of any one according to claim 1-3, it is characterized in that: described filler is that lactose is or/and pregelatinized Starch; Described tablet with lubricator is one or more the combination in magnesium stearate, sodium stearyl fumarate, Pulvis Talci, the glyceryl monostearate.
5. the described Azithromycin dispersible tablet of any one according to claim 1-3 is characterized in that: it is the preparation that the supplementary material by following weight proportion is prepared from:
250 parts of azithromycins;
12 ~ 14 parts of micropowder silica gels, 70 ~ 90 parts of microcrystalline Cellulose, with lubricator 8 ~ 10 parts of 25 ~ 40 parts of low-substituted hydroxypropyl celluloses, tablet, 30 ~ 50 parts of filleies; Wherein, tablet with lubricator is magnesium stearate, and filler is lactose.
6. the described Azithromycin dispersible tablet of any one according to claim 1-4 is characterized in that: it is the preparation that the supplementary material by following weight proportion is prepared from:
250 parts of azithromycins, 14 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 10 parts of magnesium stearate;
Or, 250 parts of azithromycins, 16 parts of micropowder silica gels, 110 parts of microcrystalline Cellulose, 20 parts of lactose, pregelatinized Starch 20 minutes, 25 parts of low-substituted hydroxypropyl celluloses, 15 parts of magnesium stearate;
Or, 250 parts of azithromycins, 14 parts of micropowder silica gels, 80 parts of microcrystalline Cellulose, 40 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 10 parts of magnesium stearate;
Or, 250 parts of azithromycins, 12 parts of micropowder silica gels, 70 parts of microcrystalline Cellulose, 50 parts of lactose, 40 parts of low-substituted hydroxypropyl celluloses, 8 parts of magnesium stearate;
Or, 250 parts of azithromycins, 15 parts of micropowder silica gels, 120 parts of microcrystalline Cellulose, 40 parts of low-substituted hydroxypropyl celluloses, 8 parts of magnesium stearate;
Or, 250 parts of azithromycins, 16 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 15 parts of Pulvis Talci;
Or, 250 parts of azithromycins, 14 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 5 parts of magnesium stearate, 10 parts of Pulvis Talci;
Or, 250 parts of azithromycins, 14 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 15 parts of sodium stearyl fumarates;
Or, 250 parts of azithromycins, 16 parts of micropowder silica gels, 90 parts of microcrystalline Cellulose, 30 parts of lactose, 25 parts of low-substituted hydroxypropyl celluloses, 15 parts of glyceryl monostearate.
7. the described Azithromycin dispersible tablet of any one according to claim 1-6, it is characterized in that: described adjuvant also comprises 1-3 part correctives.
8. the preparation method of the described Azithromycin dispersible tablet of claim 1-7 any one, it is characterized in that: it comprises following operating procedure:
(1) takes by weighing by weight ratio supplementary material;
(2) get other supplementary materials except magnesium stearate, sieve, behind the mixing, add the magnesium stearate mix homogeneously again, direct compression namely gets dispersible tablet.
9. preparation method according to claim 8, it is characterized in that: the concrete operations of step (2) are as follows:
A, get azithromycin and micropowder silica gel, mixed 80 ~ 100 mesh sieves, mix homogeneously gets powder a;
B, get other adjuvants except magnesium stearate and micropowder silica gel, mix homogeneously gets powder b;
C, powder a, b are crossed 40 ~ 60 mesh sieves, behind the mix homogeneously, add magnesium stearate again and mix, incorporation time is in 30min, and gained mixed-powder direct compression namely gets dispersible tablet.
10. preparation method according to claim 9 is characterized in that: among the step C, add that incorporation time is 5 ~ 30min after the magnesium stearate.
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| CN201510191211.2A CN104825408A (en) | 2012-12-31 | 2012-12-31 | Azithromycin dispersible tablet and preparation method and use thereof |
| CN2012105902402A CN103040778A (en) | 2012-12-31 | 2012-12-31 | Azithromycin dispersible tablet, as well as preparation method and application thereof |
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Cited By (5)
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| CN103550181A (en) * | 2013-11-04 | 2014-02-05 | 深圳致君制药有限公司 | Azithromycin dispersible tablet and preparation method thereof |
| CN103655496A (en) * | 2013-12-10 | 2014-03-26 | 山东淄博新达制药有限公司 | Azithromycin dispersible tablet and preparation process thereof |
| CN112315924A (en) * | 2020-11-10 | 2021-02-05 | 迪沙药业集团有限公司 | Azithromycin composition and preparation method thereof |
| CN113559073A (en) * | 2021-07-20 | 2021-10-29 | 海南海神同洲制药有限公司 | Azithromycin tablet and preparation method thereof |
| CN114983954A (en) * | 2022-06-15 | 2022-09-02 | 广州新济药业科技有限公司 | Folic acid tablet and preparation method thereof |
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| CN106279312B (en) * | 2016-08-16 | 2019-08-20 | 珠海同源药业有限公司 | A kind of azithromycin compound and combinations thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103550181A (en) * | 2013-11-04 | 2014-02-05 | 深圳致君制药有限公司 | Azithromycin dispersible tablet and preparation method thereof |
| CN103550181B (en) * | 2013-11-04 | 2015-06-17 | 深圳致君制药有限公司 | Azithromycin dispersible tablet and preparation method thereof |
| CN103655496A (en) * | 2013-12-10 | 2014-03-26 | 山东淄博新达制药有限公司 | Azithromycin dispersible tablet and preparation process thereof |
| CN112315924A (en) * | 2020-11-10 | 2021-02-05 | 迪沙药业集团有限公司 | Azithromycin composition and preparation method thereof |
| CN113559073A (en) * | 2021-07-20 | 2021-10-29 | 海南海神同洲制药有限公司 | Azithromycin tablet and preparation method thereof |
| CN114983954A (en) * | 2022-06-15 | 2022-09-02 | 广州新济药业科技有限公司 | Folic acid tablet and preparation method thereof |
| CN114983954B (en) * | 2022-06-15 | 2023-09-12 | 广州新济药业科技有限公司 | Folic acid tablet and preparation method thereof |
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| Publication number | Publication date |
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| CN104825408A (en) | 2015-08-12 |
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Application publication date: 20130417 |