CN106236754A - A kind of compositions comprising Li Gelieting active component and preparation method thereof - Google Patents
A kind of compositions comprising Li Gelieting active component and preparation method thereof Download PDFInfo
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- CN106236754A CN106236754A CN201610612485.9A CN201610612485A CN106236754A CN 106236754 A CN106236754 A CN 106236754A CN 201610612485 A CN201610612485 A CN 201610612485A CN 106236754 A CN106236754 A CN 106236754A
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- gelieting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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Abstract
A kind of compositions comprising Li Gelieting active component that the invention discloses Li Gelieting and preparation method thereof.In addition to active component Li Gelieting, adjuvant composition has mannitol, pregelatinized Starch, corn starch, polyvidone, magnesium stearate, described adjuvant composition includes 80 150 parts of mannitol in parts by weight, pregelatinized Starch 10 60 parts, corn starch 1 30 parts, polyvidone 1 10 parts, magnesium stearate 15 parts.Fluidized bed granulation of the present invention integrates mixing, pelletizes, is dried, and decreases the exposed link of pelletization, operates simpler, controlled.And Li Gelieting uses the method that suspendible sprays into, beneficially Li Gelieting mix homogeneously in prescription.
Description
Technical field: the invention belongs to field of pharmaceutical preparations, is specifically related to Li Gelieting tablet composition and preparation method.
Background technology
Li Gelieting (Linagliptin, structural formula is as shown in formula 1), is a kind of dipeptidy peptidase in inhibitors, changes
Formal name used at school is 1-[(4-methyl-quinazoline-2-base) methyl]-3-methyl-7-(2-butine-1-base)-8-
[3-(R)-amino-piperidines-1-base]-xanthine, by Boehringer Ingelheim, company develops.This product and metformin and
Sulfonylurea drugs is used in combination, and coordinates diet control and motion, the glycemic control of 2 diabetes mellitus types that can be used for growing up.
Inquiry data, it can be seen that the preparation technology of Li Gelieting sheet is efficient wet granulation, efficiently from each patent prescription
Wet granulation technique is the method being most widely used in medical industry, but technique is complex.Fluidized bed granulation be collection mixing,
Pelletize, be dried the granulation technique being integrated, compared with wet granulation technique, eliminate the step of wet granulation, its time-saving energy-saving,
Simple process, technique are few.And fluidized bed granulation gained granule is more fluffy, the dissolution of medicine can be improved.
Summary of the invention:
The invention provides the granulation mode of a kind of new Li Gelieting, its object is to make the preparation technology of Li Gelieting more
Simply, easily operate.Still further provides the adjuvant composition of a kind of Li Gelieting fluidized bed granulation, this adjuvant composition and Li Ge
After the mixing of row spit of fland, the dissolution of medicine can be improved.
A kind of compositions comprising Li Gelieting active component, its scheme is: in addition to active component Li Gelieting, adjuvant group
Become to have mannitol, pregelatinized Starch, corn starch, binding agent, magnesium stearate, described adjuvant composition to include in parts by weight
Mannitol 80-150 part, pregelatinized Starch 10-60 part, corn starch 1-30 part, polyvidone 1-10 part, magnesium stearate 1-5 part.
Preferably, described adjuvant composition includes mannitol 100-140 part, pregelatinized Starch 15-40 in parts by weight
Part, corn starch 5-20 part.
Preferably, binding agent is the povidone solution of 3%-6%.
Preferably, it is fluidized bed granulation for Li Gelieting sheet granulating process, binder aqueous solution adds 10-30% second
Alcohol.
Preferably, described binder aqueous solution adds 10% ethanol.
Preferably, based on Li Gelieting fluidized bed granulation, it is characterised in that dried pellet moisture should control at 2-4%.
Preferably, Li Gelieting in pelletization be suspendible in the solution, solution is aqueous solution or alcoholic solution.
Preferably, based on Li Gelieting fluid bed gained moisture 2-4% granule, during tabletting, pressure should control at 60-80N.
Preferably, described binder aqueous solution adds 10% ethanol.
Preferably, binding agent is 3% povidone solution.
Preferably, described polyvidone can be changed to copolyvidone.
Preferably, described compositions is coated with thin membrane coated tablet.
Preferably, during thin membrane coated tablet, described film-coating material weight is the 2 ~ 4% of coated cores weight.
Present invention also offers a kind of preparation method of composition comprising Li Gelieting active component, it is characterised in that:
Mannitol, pregelatinized Starch, corn starch are put in the most preheated fluid bed, after mixing, sprays into binding agent former
Material suspension is pelletized, and is then dried to pellet moisture 2-4%, after 30 mesh granulate, adds 1.5% magnesium stearate mixing, lattice of i.e. getting profit
Row spit of fland compositions.
Preferably, mannitol, pregelatinized Starch, corn starch are put in the most preheated fluid bed, after mixing, spray
Enter mannitol raw material suspension, be then sprayed into binding agent, then be dried to pellet moisture 2-4%, after 30 mesh granulate, add 1.5% hard
Fatty acid magnesium mixes, Ge Lieting compositions of i.e. getting profit.
Preferably, by Li Gelieting compositions tabletting, Ge Lieting tablet of i.e. getting profit.
Preferably, in mannitol raw material suspension, mannitol consumption is the 1/8-1/5 of recipe quantity mannitol.
Fluidized bed granulation of the present invention integrates mixing, pelletizes, is dried, and decreases the exposed link of pelletization, operation
Simpler, controlled.And Li Gelieting uses the method that suspendible sprays into, beneficially Li Gelieting mix homogeneously in prescription.
It is embodied as content:
Below in conjunction with embodiment, the present invention is described in further detail, to help understanding present disclosure.
Embodiment 1
| Li Gelieting | 40g |
| Pregelatinized Starch | 248g |
| Corn starch | 40g |
| Mannitol | 1042.4g |
| 30 POVIDONE K 30 BP/USP 90 | 48g |
| Magnesium stearate | 21.6g |
| Make altogether | 8000 |
Technique:
Raw material suspension is prepared: weighs recipe quantity 1/6 mannitol and is dissolved in 800g water, then by raw material suspendible wherein.
Binding agent is prepared: weighs recipe quantity 30 POVIDONE K 30 BP/USP 90 and is dissolved in suitable quantity of water, makes 6% 30 POVIDONE K 30 BP/USP 90 aqueous solution.
First fluidised bed granulator sky is heated to parameter stability (temperature: 60 DEG C), then will residue mannitol, pregelatinized Starch
And corn starch puts in fluidised bed granulator, mix 10min, spray into raw material suspension, after having sprayed, then spray into binding agent (root
According to graininess, control between the spray stopping time), after drying, pellet moisture controls at 2-4%.
Embodiment 2
| Li Gelieting | 40g |
| Pregelatinized Starch | 248g |
| Corn starch | 40g |
| Mannitol | 1042.4g |
| 30 POVIDONE K 30 BP/USP 90 | 48g |
| Magnesium stearate | 21.6g |
| Make altogether | 8000 |
Technique:
Binding agent is prepared: weighs recipe quantity 30 POVIDONE K 30 BP/USP 90 and is dissolved in suitable quantity of water, makes 3% 30 POVIDONE K 30 BP/USP 90 aqueous solution, mixed by raw material
Hang wherein.
First fluidised bed granulator sky is heated to parameter stability (temperature: 60 DEG C), then will residue mannitol, pregelatinized Starch
And corn starch puts in fluidised bed granulator, mix 10min, spray into binding agent (according to graininess, control between the spray stopping time),
After drying, pellet moisture controls at 2-4%.
Embodiment 3
| Li Gelieting | 40g |
| Pregelatinized Starch | 248g |
| Corn starch | 40g |
| Mannitol | 1042.4g |
| Copolyvidone | 48g |
| Magnesium stearate | 21.6g |
| Make altogether | 8000 |
Technique:
Binding agent is prepared: weighs recipe quantity copolyvidone soluble in water, makes the aqueous solution of 15% copolyvidone, by raw material suspendible
Wherein.
First fluidised bed granulator sky is heated to parameter stability (temperature: 60 DEG C), then will residue mannitol, pregelatinized Starch
And corn starch puts in fluidised bed granulator, mix 10min, spray into binding agent (according to graininess, control between the spray stopping time),
After drying, pellet moisture controls at 2-4%.
Embodiment 4
| Li Gelieting | 40g |
| Pregelatinized Starch | 248g |
| Corn starch | 40g |
| Mannitol | 1042.4g |
| 30 POVIDONE K 30 BP/USP 90 | 48g |
| Magnesium stearate | 21.6g |
| Make altogether | 8000 |
Technique:
Raw material suspension is prepared: weighs recipe quantity 1/6 mannitol and is dissolved in 800g water, then by raw material suspendible wherein.
Binding agent is prepared: weighs recipe quantity 30 POVIDONE K 30 BP/USP 90 and is dissolved in 20% alcoholic solution, makes 20% alcohol of 6% 30 POVIDONE K 30 BP/USP 90
Solution
First fluidised bed granulator sky is heated to parameter stability (temperature: 60 DEG C), then mannitol, pregelatinized Starch and jade will be remained
Rice starch puts in fluidised bed granulator, mixes 10min, sprays into binding agent (according to graininess, control between the spray stopping time), is dried
After, pellet moisture controls at 2-4%.
Embodiment 5
| Li Gelieting | 40g |
| Pregelatinized Starch | 248g |
| Corn starch | 40g |
| Mannitol | 1042.4g |
| 30 POVIDONE K 30 BP/USP 90 | 48g |
| Magnesium stearate | 21.6g |
| Make altogether | 8000 |
Technique:
Binding agent is prepared: first takes 1/6 mannitol and is dissolved in suitable quantity of water, weighs recipe quantity 30 POVIDONE K 30 BP/USP 90 and be dissolved in wherein to clarification,
Add ethanol in proper amount, by recipe quantity raw material suspendible wherein, make 20% alcoholic solution of 3% 30 POVIDONE K 30 BP/USP 90.
First fluidised bed granulator sky is heated to parameter stability (temperature: 60 DEG C), then will residue mannitol, pregelatinized Starch
And corn starch puts in fluidised bed granulator, mix 10min, spray into binding agent (according to graininess, control between the spray stopping time),
After drying, pellet moisture controls at 2-4%.
Claims (15)
1. the compositions comprising Li Gelieting active component, it is characterised in that in addition to active component Li Gelieting, adjuvant group
Become to have mannitol, pregelatinized Starch, corn starch, binding agent, magnesium stearate, described adjuvant composition to include in parts by weight
Mannitol 80-150 part, pregelatinized Starch 10-60 part, corn starch 1-30 part, polyvidone 1-10 part, magnesium stearate 1-5 part.
Compositions the most according to claim 1, it is characterised in that: described adjuvant composition includes manna in parts by weight
Alcohol 100-140 part, pregelatinized Starch 15-40 part, corn starch 5-20 part.
Compositions the most according to claim 1, it is characterised in that: binding agent is the povidone solution of 3%-6%.
Compositions the most according to claim 1, it is characterised in that: it is fluid bed system for Li Gelieting sheet granulating process
Grain, adds 10-30% ethanol in binder aqueous solution.
Compositions the most according to claim 1, it is characterised in that: described binder aqueous solution adds 10% ethanol.
Compositions the most according to claim 1, it is characterised in that: based on Li Gelieting fluidized bed granulation, it is characterised in that
Dried pellet moisture should control at 2-4%.
Compositions the most according to claim 1, it is characterised in that: Li Gelieting is to be suspended in solution in pelletization
In, solution is aqueous solution or alcoholic solution.
Compositions the most according to claim 1, it is characterised in that: based on Li Gelieting fluid bed gained moisture 2-4%
Grain, during tabletting, pressure should control at 60-80N.
Compositions the most according to claim 4, it is characterised in that: described binder aqueous solution adds 10% ethanol.
Compositions the most according to claim 4, it is characterised in that: binding agent is 3% povidone solution.
11. compositionss according to claim 4, it is characterised in that: described polyvidone can be changed to copolyvidone.
12. 1 kinds of preparation method of composition comprising Li Gelieting active component, it is characterised in that:
Mannitol, pregelatinized Starch, corn starch are put in the most preheated fluid bed, after mixing, sprays into binding agent former
Material suspension is pelletized, and is then dried to pellet moisture 2-4%, after 30 mesh granulate, adds 1.5% magnesium stearate mixing, lattice of i.e. getting profit
Row spit of fland compositions.
13. methods according to claim 12, it is characterised in that: mannitol, pregelatinized Starch, corn starch are put into pre-
In the most preheated fluid bed, after mixing, spray into mannitol raw material suspension, be then sprayed into binding agent, then be dried to granule water
Divide 2-4%, after 30 mesh granulate, add 1.5% magnesium stearate mixing, Ge Lieting compositions of i.e. getting profit.
14. methods according to claim 12, it is characterised in that: by Li Gelieting compositions tabletting, i.e. get profit Ge Lieting
Tablet.
15. methods according to claim 12, it is characterised in that: in mannitol raw material suspension, mannitol consumption is place
The 1/8-1/5 of mannitol measures in side.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610612485.9A CN106236754A (en) | 2016-07-31 | 2016-07-31 | A kind of compositions comprising Li Gelieting active component and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610612485.9A CN106236754A (en) | 2016-07-31 | 2016-07-31 | A kind of compositions comprising Li Gelieting active component and preparation method thereof |
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| CN106236754A true CN106236754A (en) | 2016-12-21 |
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| CN201610612485.9A Pending CN106236754A (en) | 2016-07-31 | 2016-07-31 | A kind of compositions comprising Li Gelieting active component and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106137991A (en) * | 2016-08-01 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of Li Gelieting sheet method of granulating |
| CN110917154A (en) * | 2019-12-12 | 2020-03-27 | 上海信谊天平药业有限公司 | Preparation method of levonorgestrel tablets |
| CN115227661A (en) * | 2022-09-22 | 2022-10-25 | 北京惠之衡生物科技有限公司 | Linagliptin tablet and preparation method thereof |
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| CN104840960A (en) * | 2014-02-14 | 2015-08-19 | 广东东阳光药业有限公司 | Antidiabetic pharmaceutical composition and preparation method thereof |
| CN105456270A (en) * | 2014-08-27 | 2016-04-06 | 石药集团中奇制药技术（石家庄）有限公司 | Dipeptidyl peptidase IV inhibitor pharmaceutical composition, use and preparation method thereof |
| CN105496970A (en) * | 2015-12-18 | 2016-04-20 | 北京华禧联合科技发展有限公司 | Composition containing linagliptin and preparation method thereof |
| CN106137991A (en) * | 2016-08-01 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of Li Gelieting sheet method of granulating |
-
2016
- 2016-07-31 CN CN201610612485.9A patent/CN106236754A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101437493A (en) * | 2006-05-04 | 2009-05-20 | 贝林格尔.英格海姆国际有限公司 | DPP IV inhibitor formulations |
| CN104840960A (en) * | 2014-02-14 | 2015-08-19 | 广东东阳光药业有限公司 | Antidiabetic pharmaceutical composition and preparation method thereof |
| CN105456270A (en) * | 2014-08-27 | 2016-04-06 | 石药集团中奇制药技术（石家庄）有限公司 | Dipeptidyl peptidase IV inhibitor pharmaceutical composition, use and preparation method thereof |
| CN105496970A (en) * | 2015-12-18 | 2016-04-20 | 北京华禧联合科技发展有限公司 | Composition containing linagliptin and preparation method thereof |
| CN106137991A (en) * | 2016-08-01 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of Li Gelieting sheet method of granulating |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106137991A (en) * | 2016-08-01 | 2016-11-23 | 合肥远志医药科技开发有限公司 | A kind of Li Gelieting sheet method of granulating |
| CN110917154A (en) * | 2019-12-12 | 2020-03-27 | 上海信谊天平药业有限公司 | Preparation method of levonorgestrel tablets |
| CN115227661A (en) * | 2022-09-22 | 2022-10-25 | 北京惠之衡生物科技有限公司 | Linagliptin tablet and preparation method thereof |
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