CN106137991A - A kind of Li Gelieting sheet method of granulating - Google Patents

A kind of Li Gelieting sheet method of granulating Download PDF

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Publication number
CN106137991A
CN106137991A CN201610618521.2A CN201610618521A CN106137991A CN 106137991 A CN106137991 A CN 106137991A CN 201610618521 A CN201610618521 A CN 201610618521A CN 106137991 A CN106137991 A CN 106137991A
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CN
China
Prior art keywords
parts
gelieting
mixing
mannitol
starch
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201610618521.2A
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Chinese (zh)
Inventor
金慧芳
王志国
刘斐
孙松
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
HEFEI YUANZHI PHARMACEUTICAL R & D Co Ltd
Original Assignee
HEFEI YUANZHI PHARMACEUTICAL R & D Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by HEFEI YUANZHI PHARMACEUTICAL R & D Co Ltd filed Critical HEFEI YUANZHI PHARMACEUTICAL R & D Co Ltd
Priority to CN201610618521.2A priority Critical patent/CN106137991A/en
Publication of CN106137991A publication Critical patent/CN106137991A/en
Pending legal-status Critical Current

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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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)

Abstract

A kind of Li Gelieting sheet method of granulating.Weigh 100 140 parts of mannitol in parts by weight, pregelatinized Starch 15 40 parts, corn starch 5 20 parts, then putting in the most preheated fluid bed by mannitol, pregelatinized Starch, corn starch, after mixing, the suspension spraying into binding agent polyvidone and Li Gelieting is blended grain, then it is dried to pellet moisture 2 4%, after 30 mesh granulate, add 1.5% magnesium stearate mixing, Ge Lieting granule of i.e. getting profit.The inventive method is pelletized and is integrated mixing, pelletizes, is dried, and decreases the exposed link of pelletization, operates simpler, controlled.

Description

A kind of Li Gelieting sheet method of granulating
Technical field
The present invention relates to pharmaceutical granulation technical field, be specifically related to a kind of Li Gelieting sheet method of granulating.
Background technology
Li Gelieting (Linagliptin Tablets), Li Gelieting are a kind of dipeptidyl peptidase-4 (DPP-4) suppression Agent, can improve the different blood glucose levels of type 2 diabetes mellitus (T2DM) adult patients on the basis of diet control and physical training.But The method of granulating operation being current is complicated, difficult to be controlled.
Summary of the invention
The technical problem to be solved in the present invention is the defect overcoming prior art, it is provided that a kind of Li Gelieting industrialized production Method.
In order to solve above-mentioned technical problem, the invention provides following technical scheme: a kind of Li Gelieting sheet granulation side Method, its scheme is as follows:
Weighing mannitol 100-140 part, pregelatinized Starch 15-40 part in parts by weight, corn starch 5-20 part, then by sweet Dew alcohol, pregelatinized Starch, corn starch are put in the most preheated fluid bed, after mixing, spray into binding agent polyvidone and profit The suspension of Ge Lieting is blended grain, is then dried to pellet moisture 2-4%, after 30 mesh granulate, adds 1.5% magnesium stearate mixing, i.e. Get profit Ge Lieting granule.
The inventive method is pelletized and is integrated mixing, pelletizes, is dried, and decreases the exposed link of pelletization, operates more Simply, controlled.
Embodiment
Embodiment 1
Weighing 100 parts of mannitol, pregelatinized Starch 15 parts in parts by weight, corn starch 5 parts, then by mannitol, pre-glue Change starch, corn starch and put in the most preheated fluid bed, after mixing, spray into the outstanding of binding agent polyvidone and Li Gelieting Liquid is blended grain, is then dried to pellet moisture 3%, after 30 mesh granulate, adds 1.5% magnesium stearate mixing, i.e. gets profit Ge Lieting Grain.
Embodiment 2
Weighing 140 parts of mannitol, pregelatinized Starch 35 parts in parts by weight, corn starch 15 parts, then by mannitol, pre-glue Change starch, corn starch and put in the most preheated fluid bed, after mixing, spray into the outstanding of binding agent polyvidone and Li Gelieting Liquid is blended grain, is then dried to pellet moisture 2%, after 30 mesh granulate, adds 1.5% magnesium stearate mixing, i.e. gets profit Ge Lieting Grain.
Embodiment 3
Weighing 130 parts of mannitol, pregelatinized Starch 40 parts in parts by weight, corn starch 20 parts, then by mannitol, pre-glue Change starch, corn starch and put in the most preheated fluid bed, after mixing, spray into the outstanding of binding agent polyvidone and Li Gelieting Liquid is blended grain, is then dried to pellet moisture 4%, after 30 mesh granulate, adds 1.5% magnesium stearate mixing, i.e. gets profit Ge Lieting Grain.

Claims (1)

1. Yi Zhong Li Gelieting sheet method of granulating, it is characterised in that weigh mannitol 100-140 part, pre-glue in parts by weight Change starch 15-40 part, corn starch 5-20 part, then mannitol, pregelatinized Starch, corn starch are put into the most preheated In fluid bed, after mixing, the suspension spraying into binding agent polyvidone and Li Gelieting is blended grain, is then dried to pellet moisture 2- 4%, after 30 mesh granulate, add 1.5% magnesium stearate mixing, Ge Lieting granule of i.e. getting profit.
CN201610618521.2A 2016-08-01 2016-08-01 A kind of Li Gelieting sheet method of granulating Pending CN106137991A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201610618521.2A CN106137991A (en) 2016-08-01 2016-08-01 A kind of Li Gelieting sheet method of granulating

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201610618521.2A CN106137991A (en) 2016-08-01 2016-08-01 A kind of Li Gelieting sheet method of granulating

Publications (1)

Publication Number Publication Date
CN106137991A true CN106137991A (en) 2016-11-23

Family

ID=57328322

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201610618521.2A Pending CN106137991A (en) 2016-08-01 2016-08-01 A kind of Li Gelieting sheet method of granulating

Country Status (1)

Country Link
CN (1) CN106137991A (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106236754A (en) * 2016-07-31 2016-12-21 合肥远志医药科技开发有限公司 A kind of compositions comprising Li Gelieting active component and preparation method thereof
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

Citations (5)

* Cited by examiner, † Cited by third party
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
CN106236754A (en) * 2016-07-31 2016-12-21 合肥远志医药科技开发有限公司 A kind of compositions comprising Li Gelieting active component and preparation method thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
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
CN106236754A (en) * 2016-07-31 2016-12-21 合肥远志医药科技开发有限公司 A kind of compositions comprising Li Gelieting active component and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106236754A (en) * 2016-07-31 2016-12-21 合肥远志医药科技开发有限公司 A kind of compositions comprising Li Gelieting active component and preparation method thereof
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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Application publication date: 20161123