CN104706613B - A kind of stomach floats the preparation method of hollow sustained release tablets - Google Patents
A kind of stomach floats the preparation method of hollow sustained release tablets Download PDFInfo
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- CN104706613B CN104706613B CN201510124161.6A CN201510124161A CN104706613B CN 104706613 B CN104706613 B CN 104706613B CN 201510124161 A CN201510124161 A CN 201510124161A CN 104706613 B CN104706613 B CN 104706613B
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Abstract
The present invention discloses the preparation method that a kind of new stomach floats hollow sustained release tablets, including：(1) preparation of middle part plain piece with concave surfaces；(2) bonding of plain piece and adhesion technique.Present invention also offers one kind intragastric floating tablets as made from the above method, the tablet can keep floating state more than 24 hours in gastric juice, in the process, medicine can slow sustained release, until release is complete.A kind of new stomach provided by the present invention, which floats hollow sustained release tablets, can preferably keep the blood concentration of stable state, improve bioavilability, reduce side effect.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of stomach floats hollow sustained release tablets and preparation method thereof.
Background technology
Sustained release preparation refers in regulation dissolution medium, on request slowly non-constant velocity release medicine, its with it is corresponding general
Logical preparation compares, and administration frequency reduces half than ordinary preparation or administration frequency has been reduced than ordinary preparation, and can significantly increase
Add the preparation of the compliance of patient.Sustained release preparation is mainly to extend dissolving, release, the suction of medicine in vivo by suitable method
The processes such as receipts, reaching reduces plasma drug level fluctuation, reduces administration number of times, improves curative effect of medication, reduces the mesh of adverse reaction
's.
Intragastric floating slowly releasing preparation is one kind mainly by medicine, framework material, foaming agent, bleach activator and some other necessity
A kind of special preparation for forming of excipient compacting, be characterized in drug after oral administration floatability on gastric content, extension
Medicine is not influenceed in gastric transit time, and holdup time of the medicine in stomach by gastric emptying.Stomach floating common at present
Sustained release preparation mainly has two kinds of intumescent, effervescence type.The characteristics of intumescent gastric floating slow-release preparation is that the hydrophily in preparation is coagulated
Glue skeleton not easy disintegrating, when being contacted after oral with gastric juice, it just starts to produce hydration, and expanding makes its density be less than stomach content
Thing density (1.004~1.010g/cm3) and float on gastric juice, while dosage surface forms one layer of water impermeability gel barrier
Film, the colloidal interface layer control the diffusion rate of the medicine and solvent in preparation, so as to extend medicine in gastric transit time
And the rate of release of medicine is controlled, until carrying medicament release is complete.And the characteristics of effervescence type gastric floating slow-release preparation be
The foaming agent added in preparation can produce gas rapidly under the conditions of human gastric juice, to reach the purpose of floating.Both the above stomach
Float slow release preparation be all place one's entire reliance upon auxiliary material species and dosage ease up reaching medicine in floating in stomach the mesh of On The Drug Release
.
The new stomach of tablet flotation property can be kept to float hollow sustained release system for a long time using the special construction of itself
The agent country has not been reported.DomeStructure is the typical structure of the current external hollow preparation studied, but
DomeThe hollow tablet of structure need suppress two kinds of complementary structures tablet, complex manufacturing technology, meanwhile, DomeThe hollow tablet of structure mainly uses physics wedging function that both are joined together, and this joint is made
Tablet configuration is insecure, easily rupturable, and is more easy to be damaged in process in leaching, and when causing floating of the tablet in gastric juice
Between be merely able to reach 5~6 hours.Therefore, the present inventor have studied a kind of stomach for problem above and float hollow sustained release tablets, have
It can float on for a long time on gastric content, delay the characteristics of Slow release.
The content of the invention
The invention provides a kind of stomach to float hollow sustained release tablets and preparation method thereof, and it is new specifically to provide a kind of application
Intragastric floating tablets prepared by the tablet machining process of type.
A kind of stomach floats the preparation method of hollow sustained release tablets, comprises the following steps：
(1) preparation of plain piece：After main ingredient and pharmaceutic adjuvant are mixed by recipe quantity, No. five sieves (180 μm ± 7.6 μm) are crossed,
Using compression mold, it is in plane plain piece to suppress middle part to have concave surface, week edge, standby；
(2) preparation of tablet unit：The plain piece that is obtained in step (1) is uniformly sprayed on using the coating solution prepared in advance
Concave surface and its all edges, form coatings on the surface on concave surface and its all edges, and plain piece collectively constitutes tablet unit with coatings；
(3) preparation of hollow tablet：Before the coatings of the tablet unit of gained are unseasoned in step (2), by two panels piece
Agent unit has the corresponding fastening of the one side of the concave surface, bonds the week edge of two tablet units under 5~20N pressure
To form the hollow tablet with capsule space, finally the hollow tablet bonded is placed in baking oven, at 40 DEG C~60 DEG C
At a temperature of dry drying, produce the stomach and float hollow sustained release tablets.
The compression mold has upper trimming die and lower punch, and the lower punch is a diameter of 7~15mm female punch die, described
Upper trimming die is public punch die of the middle part with prominent disk corresponding with the lower punch, the diameter of the prominent disk is 5~
11mm, the diameter of the prominent disk are less than the diameter of the lower punch, and the projecting height of the prominent disk is 1~5mm.
The plain piece accounts for the 75%~98% of tablet unit weight, the coatings account for tablet unit weight 2%~
25%；The dosage of the main ingredient accounts for the 5%~50% of plain piece weight, the dosage of the pharmaceutic adjuvant account for plain piece weight 50%~
95%.
The main ingredient is one kind in diltiazem hydrochloride, Norfloxacin, ACV and Carvedilol.
The pharmaceutic adjuvant includes hydrophilic gel framework material, filler, disintegrant and lubricant, and each component accounts for institute
The percentage by weight for stating pharmaceutic adjuvant is as follows：
The hydrophilic gel framework material includes hydroxypropyl methyl cellulose, sodium alginate, sodium carboxymethylcellulose, first
One or more in base cellulose and ethyl cellulose；The filler includes dextrin, microcrystalline cellulose, lactose, starch, pre-
One or more in gelling starch and beta-schardinger dextrin；The disintegrant includes PVPP, low-substituted hydroxypropyl
One or more in base cellulose and sodium carboxymethyl starch；The lubricant includes magnesium stearate, talcum powder and dodecyl
One or more in sodium sulphate.
The raw material of the coating solution includes tablet coating material, solvent and plasticizer, and each component accounts for the coating solution
Percentage by weight is as follows：
Tablet coating material 5%~25%
Solvent 70%~90%
Plasticizer 1%~5%.
The tablet coating material be acrylic resin, carbomer, ethyl cellulose, low viscosity (viscosity be 15~
The one or more in hydroxypropyl methyl cellulose and sodium carboxymethylcellulose 400mPas)；The solvent is water, 95%
One or more in ethanol, acetone and isopropanol；The plasticizer includes triethyl citrate, Macrogol 6000, lemon
One kind in sour tributyl and dibutyl sebacate.
The raw material of the coating solution also includes antiplastering aid and defoamer, and this two kinds of components account for the weight percent of the coating solution
Than as follows：
Antiplastering aid 1%~8%；
Defoamer 0.01%~0.05%.
The antiplastering aid be talcum powder, magnesium stearate, lauryl sodium sulfate and glycerin monostearate in one kind or
It is several；The defoamer is methyl-silicone oil.
A kind of stomach prepared by the present invention floats hollow sustained release tablets, and Dome is different from structureThe sky of structure
Core structure, hollow tablet of the invention only need to suppress a kind of relatively easy with plain piece with concave surfaces, manufacture craft.Profit of the invention
With special packaging technique then obtained tablet unit is bonded into by the concave surface of plain piece and its week two-by-two along being coated
For hollow tablet, the capsule heart is internally formed in hollow tablet, the stomach is produced and floats hollow sustained release tablets, keeps it overall close with this
Degree is less than gastric content density (1.004~1.010g/cm3), while the slow release of main ingredient depends on hydrophilic gel skeleton
The duct that is formed of gradual expansion and pharmaceutic adjuvant gradual corrosion, so as to reach float on for a long time on gastric content,
The purpose of slow Slow release.
Coating solution used in the present invention has the effect that：One is to provide adhesive effect so that two tablet units can be with
The hollow tablet of an entirety is bonded into, so that the hollow-core construction inside tablet can be completely presented；Second, in hollow tablet
During corrosion so that the hollow-core construction of hollow tablet exists all the time during whole tablet corrosion, effectively extends sky
Lamination agent is kept for the time of its integrality, maintains lasting floating of the hollow tablet in gastric juice.
Therefore, a kind of stomach of the present invention, which floats hollow sustained release tablets, has unique preparation technology and technical characterstic, is characterized in：
The flotation property of tablet is mainly kept by itself special hollow-core construction, and the formation of hollow-core construction again relies on holding
The special art for coating of special compression mold and later stage.
Brief description of the drawings
Fig. 1 a are the structural representation of middle part plain piece with concave surfaces, and Fig. 1 b are the full wafer tablet after two tablet unit bondings
Structural representation；
Fig. 2 is that the diltiazem hydrochloride stomach of embodiment 1 floats hollow sustained release tablets cumulative release curve, n=6；
Fig. 3 is that the Norfloxacin stomach of embodiment 2 floats hollow sustained release tablets cumulative release curve, n=6；
Fig. 4 is that the Norfloxacin stomach of embodiment 3 floats hollow sustained release tablets cumulative release curve, n=6；
Fig. 5 is that the ACV stomach of embodiment 4 floats hollow sustained release tablets cumulative release curve, n=6；
Fig. 6 is that the Carvedilol stomach of embodiment 5 floats hollow sustained release tablets cumulative release curve, n=6.
Embodiment
A kind of stomach of the present invention floats hollow sustained release tablets, is carried out referring in particular to following embodiments.
(1) preparation technology：
A, the preparation of plain piece：The main ingredient of recipe quantity and each pharmaceutic adjuvant are weighed, after they are mixed, No. five is crossed and sieves (180 μm
± 7.6 μm), using compression mold, it is in plane plain piece to suppress middle part to have concave surface, week edge, as shown in Figure 1a, standby；
B, the preparation of coating solution：Tablet coating material, plasticizer and the antiplastering aid for weighing recipe quantity are dissolved in solvent, fully
Stirring, with (355 μm ± 13 μm) filterings of No. three sieves, it is standby to obtain coating solution；If the prescription of coating solution includes defoamer,
Defoamer is added after above-mentioned stirring, is then stirred for 30min, finally with (355 μm ± 13 μm) filterings of No. three sieves, is obtained
Coating solution is standby；
C, the preparation of tablet unit：Using above-mentioned coating solution uniformly spray the plain piece obtained in step a concave surface and its
All edges, coatings are formed on the surface on concave surface and its all edges, plain piece and coatings collectively constitute tablet unit；
D, the preparation of hollow tablet：Before the coatings of the tablet unit obtained by step c are unseasoned, by two tablet units
Have the corresponding fastening of one side with concave surfaces, will have under 5~20N pressure along being glued together to be formed in the week of two tablet units
The hollow tablet in capsule space, as shown in Figure 1 b, finally the hollow tablet bonded is placed in baking oven, at 40 DEG C~60 DEG C
At a temperature of dry drying, produce the stomach and float hollow sustained release tablets.
In step a, compression mold has a upper trimming die and lower punch, and lower punch is a diameter of 7~15mm female punch die, upper punching
Mould is public punch die of the middle part corresponding with lower punch with prominent disk, and the diameter of prominent disk is 5~11mm, prominent disk
Diameter is less than the diameter of lower punch, and the projecting height of prominent disk is 1~5mm.
In tablet unit, plain piece accounts for the 75%~98% of tablet unit weight, and coatings account for the 2% of tablet unit weight
~25%；The dosage of main ingredient accounts for the 5%~50% of plain piece weight, and the dosage of pharmaceutic adjuvant accounts for the 50%~95% of plain piece weight.
Wherein, main ingredient is one kind in diltiazem hydrochloride, Norfloxacin, ACV and Carvedilol.
Pharmaceutic adjuvant includes hydrophilic gel framework material, filler, disintegrant and lubricant, and each component accounts for medicinal auxiliary
The percentage by weight of material is as follows：
Wherein, hydrophilic gel framework material include hydroxypropyl methyl cellulose, sodium alginate, sodium carboxymethylcellulose,
One or more in methylcellulose and ethyl cellulose, hydroxypropyl methyl cellulose are selected from K4M, K15M and K100M wherein
One kind；Filler includes one kind or several in dextrin, microcrystalline cellulose, lactose, starch, pregelatinized starch and beta-schardinger dextrin
Kind；Disintegrant includes one kind or several in PVPP, low-substituted hydroxypropyl cellulose and sodium carboxymethyl starch
Kind；Lubricant includes the one or more in magnesium stearate, talcum powder and lauryl sodium sulfate.
The raw material of coating solution mainly includes tablet coating material, solvent and plasticizer, and each component accounts for the weight of coating solution
Percentage is as follows：
Tablet coating material 5%~25%
Solvent 70%~90%
Plasticizer 1%~5%.
Wherein, tablet coating material be acrylic resin, carbomer, ethyl cellulose, low viscosity (viscosity be 15~
The one or more in hydroxypropyl methyl cellulose and sodium carboxymethylcellulose 400mPas)；Solvent be water, 95% ethanol,
One or more in acetone and isopropanol；Plasticizer include triethyl citrate, Macrogol 6000, ATBC and
One kind in dibutyl sebacate.
The raw material of coating solution also includes antiplastering aid and defoamer, and the percentage by weight that this two kinds of components account for coating solution is as follows：
Antiplastering aid 1%~8%；
Defoamer 0.01%~0.05%.
Wherein, antiplastering aid be talcum powder, magnesium stearate, lauryl sodium sulfate and glycerin monostearate in one kind or
It is several；Defoamer is methyl-silicone oil.
(2) drug release determination
According to drug release determination method (two methods of annex XD first of Chinese Pharmacopoeia version in 2010), using dissolution method second
The device of method, using 900ml 0.1M hydrochloric acid as solvent, rotating speed be 75 turns per minute, operate in accordance with the law, through 0.5h, 1h, 2h, 3h,
4h, 5h, 6h, 8h, 10h, 12h, 14h, 16h, 24h take out solution 5ml filtrations respectively, and supplement mutually synthermal, same volume simultaneously
Long-pending 0.1M hydrochloric acid solutions.Take subsequent filtrate appropriate respectively, quantitatively diluted with 0.1M hydrochloric acid solutions and solution to be measured is made, according to ultraviolet point
Light photometry determines trap respectively at each suitable wavelength, calculates Accumulation dissolution.
Embodiment 1：Diltiazem hydrochloride stomach floats hollow sustained release tablets
(1) composition
A, plain piece prescription：
Ingredient names dosage (1000)
Main ingredient：
Diltiazem hydrochloride 100g
Pharmaceutic adjuvant：
B, coating fluid prescription：
(2) measure of Accumulation dissolution
Trap is determined respectively at 236nm wavelength according to ultraviolet spectrophotometry, calculates Accumulation dissolution, as a result as schemed
Shown in 2.
Embodiment 2：Norfloxacin stomach floats hollow sustained release tablets
(1) composition
A, plain piece prescription：
Ingredient names dosage (1000)
Main ingredient
Norfloxacin 200g
Pharmaceutic adjuvant：
B, coating fluid prescription：
(2) measure of Accumulation dissolution
Trap is determined respectively at 278nm wavelength according to ultraviolet spectrophotometry, calculates Accumulation dissolution, as a result as schemed
Shown in 3.
Embodiment 3：Norfloxacin stomach floats hollow sustained release tablets
(1) composition
A, plain piece prescription
Ingredient names dosage (1000)
Main ingredient：
Norfloxacin 400g
Pharmaceutic adjuvant：
B, coating fluid prescription：
(2) measure of Accumulation dissolution
Trap is determined respectively at 278nm wavelength according to ultraviolet spectrophotometry, calculates Accumulation dissolution, as a result as schemed
Shown in 4.
Embodiment 4：ACV stomach floats hollow sustained release tablets
(1) composition
A, plain piece prescription：
Ingredient names dosage (1000)
Main ingredient：
ACV 180g
Pharmaceutic adjuvant：
B, coating fluid prescription：
(2) measure of Accumulation dissolution
Trap is determined respectively at 254nm wavelength according to ultraviolet spectrophotometry, calculates Accumulation dissolution, as a result as schemed
Shown in 5.
Embodiment 5：Carvedilol stomach floats hollow sustained release tablets
(1) composition
A, plain piece prescription：
Ingredient names dosage (1000)
Main ingredient：
Carvedilol 50g
Pharmaceutic adjuvant：
B, coating fluid prescription：
(2) measure of Accumulation dissolution
Trap is determined respectively at 240nm wavelength according to ultraviolet spectrophotometry, calculates Accumulation dissolution, as a result as schemed
Shown in 6.
Claims (7)
1. a kind of stomach floats the preparation method of hollow sustained release tablets, it is characterised in that：Comprise the following steps：
(1) preparation of plain piece：After main ingredient and pharmaceutic adjuvant are mixed by recipe quantity, No. five sieves are crossed, using compression mold, are suppressed
There are concave surface, week in middle part along be in plane plain piece, standby, the pharmaceutic adjuvant including hydrophilic gel framework material, filler,
Disintegrant and lubricant, the percentage by weight that each component accounts for the pharmaceutic adjuvant are as follows：
It is fine that the hydrophilic gel framework material includes hydroxypropyl methyl cellulose, sodium alginate, sodium carboxymethylcellulose, methyl
One or more in dimension element and ethyl cellulose；The filler includes dextrin, microcrystalline cellulose, lactose, starch, pregelatinated
One or more in starch and beta-schardinger dextrin；It is fine that the disintegrant includes PVPP, low substituted hydroxy-propyl
One or more in dimension element and sodium carboxymethyl starch；The lubricant includes magnesium stearate, talcum powder and dodecyl sulphate
One or more in sodium；
(2) preparation of tablet unit：The concave surface of the plain piece obtained in step (1) is uniformly sprayed on using the coating solution prepared in advance
Place and its all edges, form coatings on the surface on concave surface and its all edges, and plain piece collectively constitutes tablet unit with coatings；
(3) preparation of hollow tablet：Before the coatings of the tablet unit obtained by step (2) are unseasoned, by two tablet units
The corresponding fastening of one side with the concave surface, it will be formed under 5~20N pressure along being glued together in the week of two tablet units
Hollow tablet with capsule space, finally the hollow tablet bonded is placed in baking oven, at a temperature of 40 DEG C~60 DEG C
Drying is dried, the stomach is produced and floats hollow sustained release tablets.
2. stomach according to claim 1 floats the preparation method of hollow sustained release tablets, it is characterised in that：The compression mold tool
There are upper trimming die and lower punch, the lower punch is a diameter of 7~15mm female punch die, and the upper trimming die is and the lower punch pair
The middle part answered carries the public punch die of prominent disk, and the diameter of the prominent disk is 5~11mm, and the diameter of the prominent disk is small
In the diameter of the lower punch, the projecting height of the prominent disk is 1~5mm.
3. stomach according to claim 1 floats the preparation method of hollow sustained release tablets, it is characterised in that：The plain piece accounts for tablet
The 75%~98% of unit weight, the coatings account for the 2%~25% of tablet unit weight；The dosage of the main ingredient accounts for plain piece
The 5%~50% of weight, the dosage of the pharmaceutic adjuvant account for the 50%~95% of plain piece weight.
4. stomach according to claim 1 floats the preparation method of hollow sustained release tablets, it is characterised in that：The original of the coating solution
Material includes tablet coating material, solvent and plasticizer, and the percentage by weight that each component accounts for the coating solution is as follows：
Tablet coating material 5%~25%
Solvent 70%~90%
Plasticizer 1%~5%.
5. stomach according to claim 4 floats the preparation method of hollow sustained release tablets, it is characterised in that：The tablet is coated material
Expect for acrylic resin, carbomer, ethyl cellulose, low viscosity hydroxypropyl methyl cellulose and sodium carboxymethylcellulose in
It is one or more of；The solvent is the one or more in water, 95% ethanol, acetone and isopropanol；The plasticizer includes lemon
One kind in lemon triethylenetetraminehexaacetic acid ester, Macrogol 6000, ATBC and dibutyl sebacate.
6. the stomach according to claim 4-5 floats the preparation method of hollow sustained release tablets, it is characterised in that：The coating solution
Raw material also includes antiplastering aid and defoamer, and the percentage by weight that this two kinds of components account for the coating solution is as follows：
Antiplastering aid 1%~8%；
Defoamer 0.01%~0.05%.
7. stomach according to claim 6 floats the preparation method of hollow sustained release tablets, it is characterised in that：The antiplastering aid is cunning
One or more in stone flour, magnesium stearate, lauryl sodium sulfate and glycerin monostearate；The defoamer is methyl silicon
Oil.
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|---|---|---|---|
| CN201510124161.6A CN104706613B (en) | 2015-03-20 | 2015-03-20 | A kind of stomach floats the preparation method of hollow sustained release tablets |
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| CN104706613B true CN104706613B (en) | 2018-01-16 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102112701B1 (en) * | 2018-03-30 | 2020-05-20 | 원광대학교산학협력단 | Gastroretentive controlled release formulation |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112972400A (en) * | 2021-03-09 | 2021-06-18 | 华侨大学 | Rapidly disintegrable minodronic acid granules and preparation method thereof |
| CN113577036B (en) * | 2021-05-31 | 2023-04-04 | 石药集团欧意药业有限公司 | Pregabalin gastric floating sustained release tablet and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3976764A (en) * | 1974-03-12 | 1976-08-24 | Eisai Co., Ltd. | Solid therapeutic preparation remaining in stomach |
| CN101371822A (en) * | 2007-08-20 | 2009-02-25 | 北京天衡药物研究院 | Stomach detention sustained and controlled release medicament releasing system and preparation method |
| EP2457561A1 (en) * | 2009-07-06 | 2012-05-30 | Kyorin Pharmaceutical Co., Ltd. | Tablet having hollow structure |
| CN103037850A (en) * | 2010-07-05 | 2013-04-10 | 雅戈泰克股份公司 | Dosage form |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITMI20012481A1 (en) * | 2001-11-23 | 2003-05-23 | Univ Parma | MODULAR SYSTEMS FOR THE CONTROLLED RELEASE OF SUBSTANCE WITH SPATIAL AND TEMPORAL CONTROL |
-
2015
- 2015-03-20 CN CN201510124161.6A patent/CN104706613B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3976764A (en) * | 1974-03-12 | 1976-08-24 | Eisai Co., Ltd. | Solid therapeutic preparation remaining in stomach |
| CN101371822A (en) * | 2007-08-20 | 2009-02-25 | 北京天衡药物研究院 | Stomach detention sustained and controlled release medicament releasing system and preparation method |
| EP2457561A1 (en) * | 2009-07-06 | 2012-05-30 | Kyorin Pharmaceutical Co., Ltd. | Tablet having hollow structure |
| CN103037850A (en) * | 2010-07-05 | 2013-04-10 | 雅戈泰克股份公司 | Dosage form |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102112701B1 (en) * | 2018-03-30 | 2020-05-20 | 원광대학교산학협력단 | Gastroretentive controlled release formulation |
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