CN105287421A - Paeonol gastric floating tablet and preparation method thereof - Google Patents
Paeonol gastric floating tablet and preparation method thereof Download PDFInfo
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- CN105287421A CN105287421A CN201510870678.XA CN201510870678A CN105287421A CN 105287421 A CN105287421 A CN 105287421A CN 201510870678 A CN201510870678 A CN 201510870678A CN 105287421 A CN105287421 A CN 105287421A
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Abstract
The invention relates to the field of medicinal preparations, in particular to a paeonol gastric floating tablet. The tablet is prepared from the components such as 20 to 50 percent of paeonol, 15 to 30 percent of sustained-release matrix material, 10 to 25 percent of pore-foaming agent, 0.5 to 2 percent of flow aid and 10 to 30 percent of diluent; powder is directly subjected to tabletting to prepare the gastric floating tablet. The paeonol gastric floating tablet is short in floating starting time, long in floating duration, good in stability and capable of achieving a sustained-release effect of sustained release.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, specifically relate to a kind of Chinese medicine intra-gastric floating tablet and preparation method thereof.
Background technology
Paeonol (Paeonol), also known as paeonol, is be separated the bioactive substance obtained from Chinese medicine Radix Cynanchi Paniculati and Cortex Moutan.Paeonol is that a pharmacologically active is extensive, the medicine of high-efficiency low-toxicity, mainly contain antimicrobial antiphlogistic, improve hemorheology, lipid lowering, anti-lipid peroxidation, antitumor, anti-inflammatory and antalgic, atherosclerosis, enhancing immunity, promotion microcirculation, the effect such as arrhythmia.There are some researches show that paeonol has good protective effect to digestive tract inflammatory diseasess such as stress gastric ulcers, and substantially there is no toxic and side effects.According to the literature, paeonol stress have protective effect by induced mice gastric ulcer to water, and the antiulcer degree of its high dose is similar to omeprazole, significantly can alleviate the mucosal lesion that water stress cause.But paeonol poorly water-soluble, oxidizable, biological half-life is short, and the ordinary preparation that gone on the market is difficult to allow medicine long period resident stomach, reaches the object of local and long-acting treatment disease of stomach.
In-stomach floating type preparation designs according to fluid dynamic equilibrium principle (HBS), enter after in stomach and expand in the effect lower volume of gastric environment, its apparent density is caused to be less than gastric content density, therefore can be floating state in gastric juice, not easily discharge from stomach, thus extend the holdup time of medicine at gastric.After preparation enters stomach, foaming agent and gastric juice react and generate carbon dioxide, and be coated in gel surface, add the floating force of preparation, release after ease until carbon dioxide, dosage surface can form said minuscule hole, hydrophilic gel is through hydration swelling, the permeable gel barrier film of one deck can be formed in dosage surface again, maintain preparation density and be less than gastric juice density, and Drug controlled release.
Summary of the invention
Object of the present invention aims to provide and a kind of plays at gastric that the drift time is fast, to continue the flotation time long, can play slow releasing function, and high paeonol intra-gastric floating tablet of bioavailability and preparation method thereof.
Specifically, a first aspect of the present invention there is provided a kind of paeonol intra-gastric floating tablet, and it obtains through following methods with following weight percents composition:
Paeonol 20 ~ 50%, sustained-release matrix material 15 ~ 30%, porogen 10 ~ 25%, fluidizer 0.5 ~ 2%, diluent 10 ~ 30%,
Described sustained-release matrix material be selected from hydroxypropyl emthylcellulose, Glyceryl Behenate, sodium alginate one or more, described porogen be selected from sodium bicarbonate, calcium carbonate one or more, described fluidizer be selected from micropowder silica gel or magnesium stearate one or more, described diluent be selected from spray-dried lactose or microcrystalline Cellulose one or more;
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The sustained-release matrix material of recipe quantity, porogen, diluent are crossed 60 ~ 80 mesh sieves respectively, for subsequent use;
Step 2, mixes the fluidizer of paeonol and recipe quantity, then adds diluent, porogen, sustained-release matrix material successively, crosses 60 ~ 80 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet.
In a preference, described paeonol intra-gastric floating tablet also comprise by step 3 gained element sheet carry out film-coated step, the coating material used in described film coating step is
western medicine, coating conditions is: water is lytic agent, coating solution concentration 12% ~ 15%, coating weight gain 2% ~ 3%, inlet temperature 10 ~ 30 DEG C, compressor pressure 0.2 ~ 0.4MPa, coating pan rotating speed 30 ~ 60rmp, peristaltic pump flow velocity 1.5 ~ 3mlmin
-1.
In another preference, the consumption of described paeonol is 40%.
In another preference, the consumption of described sustained-release matrix material is 20%.
In another preference, the consumption of described porogen is 15%.
In another preference, the consumption of described fluidizer is 1%.
In another preference, the consumption of described diluent is 12 ~ 25%.
In another preference, described paeonol intra-gastric floating tablet obtains through following steps with following weight percents composition:
Paeonol 40%, hydroxypropyl emthylcellulose 20%, sodium bicarbonate 15%, micropowder silica gel 1%, microcrystalline Cellulose 12%, spray-dried lactose 12%;
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The hydroxypropyl emthylcellulose of recipe quantity, sodium bicarbonate, spray-dried lactose are crossed 80 mesh sieves respectively, for subsequent use;
Step 2, mixes the micropowder silica gel of paeonol and recipe quantity, then adds spray-dried lactose, sodium bicarbonate, hydroxypropyl emthylcellulose successively, crosses 80 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet;
Optional step 4, step 3 gained element sheet is carried out film coating, and the coating material of use is
western medicine, coating conditions is: water is lytic agent, coating solution concentration 15%, coating weight gain 2%, inlet temperature 25 DEG C, compressor pressure 0.3MPa, coating pan rotating speed 50rmp, peristaltic pump flow velocity 2.5mlmin
-1.
A second aspect of the present invention there is provided the preparation method of described paeonol intra-gastric floating tablet, and described method comprises the following steps:
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The sustained-release matrix material of recipe quantity, porogen, diluent are crossed 60 ~ 80 mesh sieves respectively, for subsequent use;
Step 2, mixes the fluidizer of paeonol and recipe quantity, then adds diluent, porogen, sustained-release matrix material successively, crosses 60 ~ 80 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet.
In a preference, described method also comprises carries out film-coated step by step 3 gained element sheet, and the coating material used in described film coating step is
western medicine, coating conditions is: water is lytic agent, coating solution concentration 12% ~ 15%, coating weight gain 2% ~ 3%, inlet temperature 10 ~ 30 DEG C, compressor pressure 0.2 ~ 0.4MPa, coating pan rotating speed 30 ~ 60rmp, peristaltic pump flow velocity 1.5 ~ 3mlmin
-1.
The details of various aspects of the present invention is able to detailed description by chapters and sections subsequently.By hereafter and the description of claim, feature of the present invention, object and advantage will be more obvious.
Accompanying drawing explanation
Fig. 1 is the surface electrical scarnning mirror figure of paeonol intra-gastric floating tablet of the present invention
A: release 0h, b: release 4h.
Fig. 2 is the internal structure electron-microscope scanning figure of paeonol intra-gastric floating tablet of the present invention
A: release 0h, b: release 4h.
Detailed description of the invention
Study discovery through the present inventor, due to paeonol crude drug poorly water-soluble, wet granulation is more difficult, and time dry, paeonol loss is very large, therefore the preparation choice of powder direct compression process of label of the present invention.And direct powder compression to have technical process fairly simple, need not to granulate, dry, the advantages such as end product quality is stable.As those of ordinary skill in the art is known, in technique of direct powder compression, the selection of adjuvant is particularly important.Except requiring that adjuvant possesses except the performance of general additive of tablet, most importantly adjuvant should have good mobility and compressibility, also needs suitable bulk density and larger Dilute potential.
As used in the present invention, the consumption of crude drug paeonol in intra-gastric floating tablet of the present invention is 20 ~ 50%, is preferably 40%.
As used in the present invention, described sustained-release matrix material can be the hydrophilic gel framework material that this area is commonly used, lightweight wax material or polysaccharide macromolecular material, include but are not limited to: hydroxypropyl emthylcellulose, Glyceryl Behenate, sodium alginate etc., preferably use hydroxypropyl emthylcellulose (K4M).Above-mentioned sustained-release matrix material can be used alone or merge use.Sustained-release matrix material all plays an important role for the floating and lasting slow release of this intra-gastric floating tablet of the present invention, and its amount ranges is 15 ~ 30%, is preferably 20%.
As used in the present invention, described porogen can be the pore material that this area is commonly used, and includes but not limited to: various carbonate, as sodium bicarbonate, calcium carbonate etc.Above-mentioned pore material can be used alone or merge use.Porogen for intra-gastric floating tablet of the present invention rise drift and medicine most important from the stripping this intra-gastric floating tablet, its amount ranges is 10 ~ 25%, be preferably 15%.Discovery is studied through the present inventor, when using sodium bicarbonate as porogen, itself and sustained-release matrix material can make rising of intra-gastric floating tablet of the present invention float time advance as both hydroxypropyl emthylcelluloses combine, and medicine paeonol can be discharged completely in the slow-release time of design, therefore porogen preferably uses sodium bicarbonate.After sodium bicarbonate contacts with gastric juice, the carbon dioxide of generation is released effusion and is come from slice, thin piece, and sheet sub-surface can form hole (as shown in Figure 1), serves porogen and plays dual parts to float agent.Meanwhile, the hydroxypropyl emthylcellulose that density is less is originally powder body material, but forms gel skeleton (as shown in Figure 2) after swelling a period of time in release medium, combines form certain release duct with hole.Along with the prolongation of flotation time, release duct increases gradually, and medicine paeonol slowly discharges from preparation, and then plays the effect of slow release.
As used in the present invention, described fluidizer can be the fluidizer material that this area is commonly used, and includes but not limited to: micropowder silica gel or magnesium stearate etc.Above-mentioned pore material can be used alone or merge use.Its amount ranges is 0.5 ~ 2%, is preferably 1%.Study discovery through the present inventor, micropowder silica gel is better compared to the magnesium stearate effect through being commonly used for lubricant, adds and can obviously increase mixed-powder mobility on a small quantity.In we, principal agent paeonol crystal powder easily clumps together bulk, and adding micropowder silica gel can also effectively prevent it from luming, and its preferable amount 1% not only can prevent caking by fluidizer very well, and powder reduces angle of repose greatly.If add too much, its mobility does not only strengthen how much have impact to the compressibility of powder on the contrary compared to the consumption of 1%, and therefore we select and add 1% micropowder silica gel and make fluidizer.
As used in the present invention, described diluent can be the diluted material that this area is commonly used, and includes but not limited to: spray-dried lactose or microcrystalline Cellulose etc.Above-mentioned diluent can be used alone or merges use.Its amount ranges is 10 ~ 30%, is preferably 12 ~ 25%.The present invention's microcrystalline Cellulose model used is ph102, and this adjuvant has good mobility and compressibility, has diluent, binding agent and disintegrating agent effect concurrently, and drug loading is large, and compression molding is good, can reach very high hardness.And spray-dried lactose used is also the adjuvant for direct powder compression, the tablet surface be pressed into is bright and clean, attractive in appearance, and release medicine is fast, mobility, adhesion are all good, is the desirable filler of tablet.Both share and are more conducive to compression molding, obtain desirable hardness, are easy to tabletting.
As those of ordinary skill in the art is known, because paeonol is pin crystalline solid, mobility is poor, the uniformity of dosage units of tablet can be affected, so need in preparation process first by crude drug paeonol and fluidizer as mixings such as micropowder silica gels, improve the mobility of paeonol, then by itself and diluent as the good auxiliary materials and mixing of these mobility such as lactose or crystallite, finally by itself and all auxiliary materials and mixing.
As a kind of optimal way of the present invention, floating for obtained stomach plain sheet has also been carried out coating by the present invention.Abandon the conventional bag sugar-coat of the paeonol tablet that goes on the market, select novel film-coat coating material.Meanwhile, do not affecting the drift time, and when ensureing stability, optimizing film-coated technique, have selected best coating conditions.
Paeonol intra-gastric floating tablet element sheet of the present invention is heavily 0.2g, and hardness is 4 ~ 5kg/cm
2, play drift time < 3min, the lasting flotation time is greater than 8h, and 8h paeonol dissolution is greater than 85%, meets States Pharmacopoeia specifications.
Study confirmation through the present inventor, paeonol intra-gastric floating tablet of the present invention has the following advantages:
Paeonol intra-gastric floating tablet preparation technology of the present invention is simple, is applicable to the large production of industry, adopts the pharmaceutic adjuvant that safety is novel, by extending preparation in the time of staying of gastric and then the effect reaching raising therapeutic local concentration and therapeutic effect.It is short that paeonol intra-gastric floating tablet of the present invention plays the drift time, continues the flotation time long, and good stability, the slow release effect of sustained release can be reached.
Below in conjunction with specific embodiment, set forth the present invention further.Should be understood that these embodiments are only not used in for illustration of the present invention to limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example, the usually conveniently conditioned disjunction condition of advising according to manufacturer.
Unless otherwise defined, all specialties used in literary composition and scientific words and one skilled in the art the same meaning be familiar with.In addition, any method similar or impartial to described content and material all can be applicable in the inventive method.The use that better implementation method described in literary composition and material only present a demonstration.
The above-mentioned feature that the present invention mentions, or the feature that embodiment is mentioned can combination in any.All features that patent specification discloses can with any composition forms and use, each feature disclosed in description, anyly can provide identical, alternative characteristics that is impartial or similar object replaces.Therefore apart from special instruction, the feature disclosed is only general example that is impartial or similar features.
Embodiment 1:
As shown above, prepare 1000, concrete technology method is as follows for the every tablet recipe content of this intra-gastric floating tablet:
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The sustained-release matrix material of recipe quantity, porogen, diluent are crossed 80 mesh sieves respectively, for subsequent use;
Step 2, mixes the fluidizer of paeonol and recipe quantity, then adds diluent, porogen, sustained-release matrix material successively, crosses 80 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet.
Embodiment 2:
As shown above, prepare 1000, concrete technology method is with embodiment 1 for the every tablet recipe content of this intra-gastric floating tablet.
Embodiment 3:
| Formulation ingredients | Formulatory agents | Consumption (mg) | W/W％ |
| Crude drug | Paeonol | 80 | 40 |
| Sustained-release matrix material | HPMC-K4M | 50 | 25 |
| Porogen | Sodium bicarbonate | 40 | 20 |
| Fluidizer | Micropowder silica gel | 4 | 2 |
| Diluent | Microcrystalline Cellulose | 26 | 13 |
As shown above, prepare 1000, concrete technology method is as follows for the every tablet recipe content of this intra-gastric floating tablet:
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The sustained-release matrix material of recipe quantity, porogen, diluent are crossed 80 mesh sieves respectively, for subsequent use;
Step 2, mixes the fluidizer of paeonol and recipe quantity, then adds diluent, porogen, sustained-release matrix material successively, crosses 60 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet.
Step 4, step 3 gained element sheet is carried out film coating, and the coating material of use is
western medicine, coating conditions is: water is lytic agent, coating solution concentration 12%, coating weight gain 3%, inlet temperature 25 DEG C, compressor pressure 0.4MPa, coating pan rotating speed 60rmp, peristaltic pump flow velocity 3mlmin
-1.
Embodiment 4:
As shown above, prepare 1000, concrete technology method is with embodiment 1 for the every tablet recipe content of this intra-gastric floating tablet.
Embodiment 5:
As shown above, prepare 1000, concrete technology method is as follows for the every tablet recipe content of this intra-gastric floating tablet:
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The sustained-release matrix material of recipe quantity, porogen, diluent are crossed 60 mesh sieves respectively, for subsequent use;
Step 2, mixes the fluidizer of paeonol and recipe quantity, then adds diluent, porogen, sustained-release matrix material successively, crosses 60 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet.
Step 4, step 3 gained element sheet is carried out film coating, and the coating material of use is
western medicine, coating conditions is: water is lytic agent, coating solution concentration 14%, coating weight gain 3%, inlet temperature 30 DEG C, compressor pressure 0.3MPa, coating pan rotating speed 50rmp, peristaltic pump flow velocity 2mlmin
-1.
Embodiment 6:
As shown above, prepare 1000, concrete technology method is with embodiment 1 for the every tablet recipe content of this intra-gastric floating tablet.
Embodiment 7:
As shown above, prepare 1000, concrete technology method is as follows for the every tablet recipe content of this intra-gastric floating tablet:
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The sustained-release matrix material of recipe quantity, porogen, diluent are crossed 80 mesh sieves respectively, for subsequent use;
Step 2, mixes the fluidizer of paeonol and recipe quantity, then adds diluent, porogen, sustained-release matrix material successively, crosses 80 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet.
Step 4, step 3 gained element sheet is carried out film coating, and the coating material of use is
western medicine, coating conditions is: water is lytic agent, coating solution concentration 15%, coating weight gain 2%, inlet temperature 25 DEG C, compressor pressure 0.3MPa, coating pan rotating speed 50rmp, peristaltic pump flow velocity 2.5mlmin
-1.
Embodiment 8
Get the paeonol intra-gastric floating tablet that above-described embodiment is obtained, investigate it and play the drift time, continue flotation time and drug release in vitro curve, contrast with the common paeonol sheet of same specification simultaneously.Result of the test is as shown in the table.
Each time point drug accumulation release:
Known by above-mentioned experimental result, the paeonol intra-gastric floating tablet that the present invention obtains compared with common paeonol sheet, slow release characteristic highly significant.
Many aspects involved in the present invention have been done and have as above been set forth.It is to be understood, however, that put before not departing from spirit of the present invention, those skilled in the art can carry out equivalent change and modification to it, and described change and modification fall into the coverage of the application's claims equally.
Claims (10)
1. a paeonol intra-gastric floating tablet, is characterized in that, it obtains through following methods with following weight percents composition:
Paeonol 20 ~ 50%, sustained-release matrix material 15 ~ 30%, porogen 10 ~ 25%, fluidizer 0.5 ~ 2%, diluent 10 ~ 30%,
Described sustained-release matrix material be selected from hydroxypropyl emthylcellulose, Glyceryl Behenate, sodium alginate one or more, described porogen be selected from sodium bicarbonate, calcium carbonate one or more, described fluidizer be selected from micropowder silica gel or magnesium stearate one or more, described diluent be selected from spray-dried lactose or microcrystalline Cellulose one or more;
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The sustained-release matrix material of recipe quantity, porogen, diluent are crossed 60 ~ 80 mesh sieves respectively, for subsequent use;
Step 2, mixes the fluidizer of paeonol and recipe quantity, then adds diluent, porogen, sustained-release matrix material successively, crosses 60 ~ 80 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet.
2. paeonol intra-gastric floating tablet as claimed in claim 1, is characterized in that, it also comprises carries out film-coated step by step 3 gained element sheet, and the coating material used in described film coating step is for clinging in Europe
western medicine, coating conditions is: water is lytic agent, coating solution concentration 12% ~ 15%, coating weight gain 2% ~ 3%, inlet temperature 10 ~ 30 DEG C, compressor pressure 0.2 ~ 0.4MPa, coating pan rotating speed 30 ~ 60rmp, peristaltic pump flow velocity 1.5 ~ 3mlmin
-1.
3. paeonol intra-gastric floating tablet as claimed in claim 1 or 2, it is characterized in that, the consumption of described paeonol is 40%.
4. paeonol intra-gastric floating tablet as claimed in claim 1 or 2, it is characterized in that, the consumption of described sustained-release matrix material is 20%.
5. paeonol intra-gastric floating tablet as claimed in claim 1 or 2, it is characterized in that, the consumption of described porogen is 15%.
6. paeonol intra-gastric floating tablet as claimed in claim 1 or 2, it is characterized in that, the consumption of described fluidizer is 1%.
7. paeonol intra-gastric floating tablet as claimed in claim 1 or 2, it is characterized in that, the consumption of described diluent is 12 ~ 25%.
8. concentrated pill as claimed in claim 1 or 2, is characterized in that, it obtains through following steps with following weight percents composition:
Paeonol 40%, hydroxypropyl emthylcellulose 20%, sodium bicarbonate 15%, micropowder silica gel 1%, microcrystalline Cellulose 12%, spray-dried lactose 12%;
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The hydroxypropyl emthylcellulose of recipe quantity, sodium bicarbonate, spray-dried lactose are crossed 80 mesh sieves respectively, for subsequent use;
Step 2, mixes the micropowder silica gel of paeonol and recipe quantity, then adds spray-dried lactose, sodium bicarbonate, hydroxypropyl emthylcellulose successively, crosses 80 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet;
Optional step 4, step 3 gained element sheet is carried out film coating, and the coating material of use is
western medicine, coating conditions is: water is lytic agent, coating solution concentration 15%, coating weight gain 2%, inlet temperature 25 DEG C, compressor pressure 0.3MPa, coating pan rotating speed 50rmp, peristaltic pump flow velocity 2.5mlmin
-1.
9. the preparation method of paeonol intra-gastric floating tablet as claimed in claim 1, it is characterized in that, described method comprises the following steps:
Step one, crosses 60 mesh sieves by the paeonol of recipe quantity, for subsequent use; The sustained-release matrix material of recipe quantity, porogen, diluent are crossed 60 ~ 80 mesh sieves respectively, for subsequent use;
Step 2, mixes the fluidizer of paeonol and recipe quantity, then adds diluent, porogen, sustained-release matrix material successively, crosses 60 ~ 80 mesh sieves after mixing, for subsequent use;
Step 3, by step 2 gained mixed-powder direct compression, makes plain sheet.
10. the preparation method of paeonol intra-gastric floating tablet as claimed in claim 9, is characterized in that, described method also comprises carries out film-coated step by step 3 gained element sheet, and the coating material used in described film coating step is
western medicine, coating conditions is: water is lytic agent, coating solution concentration 12% ~ 15%, coating weight gain 2% ~ 3%, inlet temperature 10 ~ 30 DEG C, compressor pressure 0.2 ~ 0.4MPa, coating pan rotating speed 30 ~ 60rmp, peristaltic pump flow velocity 1.5 ~ 3mlmin
-1.
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| CN201510870678.XA CN105287421A (en) | 2015-12-01 | 2015-12-01 | Paeonol gastric floating tablet and preparation method thereof |
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| CN109432028A (en) * | 2018-11-30 | 2019-03-08 | 广东乾禾药用植物发展有限公司 | A kind of preparation method of Hericium erinaceus gastric floating tablet |
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Application publication date: 20160203 |
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| RJ01 | Rejection of invention patent application after publication |