WO2016161991A3 - 一种硫酸氢氯吡格雷固体制剂及其制备方法 - Google Patents

一种硫酸氢氯吡格雷固体制剂及其制备方法 Download PDF

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Publication number
WO2016161991A3
WO2016161991A3 PCT/CN2016/090137 CN2016090137W WO2016161991A3 WO 2016161991 A3 WO2016161991 A3 WO 2016161991A3 CN 2016090137 W CN2016090137 W CN 2016090137W WO 2016161991 A3 WO2016161991 A3 WO 2016161991A3
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WIPO (PCT)
Prior art keywords
preparation
method therefor
clopidogrel bisulphate
solid preparation
solid
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PCT/CN2016/090137
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English (en)
French (fr)
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WO2016161991A2 (zh
Inventor
蔡燕霞
谭岳尧
叶冠豪
Original Assignee
深圳信立泰药业股份有限公司
山东信立泰药业有限公司
惠州信立泰药业有限公司
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Application filed by 深圳信立泰药业股份有限公司, 山东信立泰药业有限公司, 惠州信立泰药业有限公司 filed Critical 深圳信立泰药业股份有限公司
Publication of WO2016161991A2 publication Critical patent/WO2016161991A2/zh
Publication of WO2016161991A3 publication Critical patent/WO2016161991A3/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4365Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

本发明提供了硫酸氢氯吡格雷固体制剂,采用熔融制粒工艺制备,所得颗粒中药物含量高,均匀性好。
PCT/CN2016/090137 2015-12-04 2016-07-15 一种硫酸氢氯吡格雷固体制剂及其制备方法 WO2016161991A2 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201510888830.7A CN105616407B (zh) 2015-12-04 2015-12-04 一种硫酸氢氯吡格雷固体制剂及其制备方法
CN201510888830.7 2015-12-04

Publications (2)

Publication Number Publication Date
WO2016161991A2 WO2016161991A2 (zh) 2016-10-13
WO2016161991A3 true WO2016161991A3 (zh) 2016-12-01

Family

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PCT/CN2016/090137 WO2016161991A2 (zh) 2015-12-04 2016-07-15 一种硫酸氢氯吡格雷固体制剂及其制备方法

Country Status (3)

Country Link
US (1) US20170157098A1 (zh)
CN (1) CN105616407B (zh)
WO (1) WO2016161991A2 (zh)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105616407B (zh) * 2015-12-04 2016-12-28 深圳信立泰药业股份有限公司 一种硫酸氢氯吡格雷固体制剂及其制备方法
CN108186604A (zh) * 2018-03-28 2018-06-22 北京睿悦生物医药科技有限公司 一种硫酸氢氯吡格雷颗粒及其制备方法
CN110339178B (zh) * 2019-06-28 2021-07-02 广州白云山天心制药股份有限公司 一种硫酸氢氯吡格雷固体制剂的制备方法
CN113057944B (zh) * 2019-12-13 2022-09-16 华益泰康药业股份有限公司 一种改善性能的片剂的制备方法
CN114767642A (zh) * 2022-03-25 2022-07-22 扬子江药业集团广州海瑞药业有限公司 硫酸氢氯吡格雷片剂及其制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101690719A (zh) * 2007-07-01 2010-04-07 深圳信立泰药业股份有限公司 一种硫酸氢氯吡格雷的固体制剂、其颗粒及其制备方法
CN105616407A (zh) * 2015-12-04 2016-06-01 深圳信立泰药业股份有限公司 一种硫酸氢氯吡格雷固体制剂及其制备方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3397385B2 (ja) * 1993-09-20 2003-04-14 第一製薬株式会社 崩壊遅延防止錠剤
CN103006599A (zh) * 2012-12-31 2013-04-03 广州白云山天心制药股份有限公司 含氯化钠药物载体的抗凝血片剂及其制备方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101690719A (zh) * 2007-07-01 2010-04-07 深圳信立泰药业股份有限公司 一种硫酸氢氯吡格雷的固体制剂、其颗粒及其制备方法
CN105616407A (zh) * 2015-12-04 2016-06-01 深圳信立泰药业股份有限公司 一种硫酸氢氯吡格雷固体制剂及其制备方法

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Publication number Publication date
CN105616407A (zh) 2016-06-01
CN105616407B (zh) 2016-12-28
WO2016161991A2 (zh) 2016-10-13
US20170157098A1 (en) 2017-06-08

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