CN114377148B - 盐酸决奈达隆药物组合物、其制备方法及应用 - Google Patents
盐酸决奈达隆药物组合物、其制备方法及应用 Download PDFInfo
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- CN114377148B CN114377148B CN202111223181.0A CN202111223181A CN114377148B CN 114377148 B CN114377148 B CN 114377148B CN 202111223181 A CN202111223181 A CN 202111223181A CN 114377148 B CN114377148 B CN 114377148B
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- Prior art keywords
- dronedarone hydrochloride
- cyclodextrin
- dronedarone
- clathrate
- pharmaceutical formulation
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- 241000282465 Canis Species 0.000 description 1
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- 208000019505 Deglutition disease Diseases 0.000 description 1
- 229920003083 Kollidon® VA64 Polymers 0.000 description 1
- 241000845082 Panama Species 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 239000003416 antiarrhythmic agent Substances 0.000 description 1
- MCOQHIWZJUDQIC-UHFFFAOYSA-N barban Chemical compound ClCC#CCOC(=O)NC1=CC=CC(Cl)=C1 MCOQHIWZJUDQIC-UHFFFAOYSA-N 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 235000021152 breakfast Nutrition 0.000 description 1
- 239000004067 bulking agent Substances 0.000 description 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
- 235000013539 calcium stearate Nutrition 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
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- 230000015556 catabolic process Effects 0.000 description 1
- WZNRVWBKYDHTKI-UHFFFAOYSA-N cellulose, acetate 1,2,4-benzenetricarboxylate Chemical compound OC1C(O)C(O)C(CO)OC1OC1C(CO)OC(O)C(O)C1O.OC1C(O)C(O)C(CO)OC1OC1C(CO)OC(O)C(O)C1O.CC(=O)OCC1OC(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(COC(C)=O)O1.CC(=O)OCC1OC(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(COC(C)=O)O1.OC(=O)C1=CC(C(=O)O)=CC=C1C(=O)OCC1C(OC2C(C(OC(=O)C=3C(=CC(=CC=3)C(O)=O)C(O)=O)C(OC(=O)C=3C(=CC(=CC=3)C(O)=O)C(O)=O)C(COC(=O)C=3C(=CC(=CC=3)C(O)=O)C(O)=O)O2)OC(=O)C=2C(=CC(=CC=2)C(O)=O)C(O)=O)C(OC(=O)C=2C(=CC(=CC=2)C(O)=O)C(O)=O)C(OC(=O)C=2C(=CC(=CC=2)C(O)=O)C(O)=O)C(OC(=O)C=2C(=CC(=CC=2)C(O)=O)C(O)=O)O1 WZNRVWBKYDHTKI-UHFFFAOYSA-N 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 239000008119 colloidal silica Substances 0.000 description 1
- -1 compound hydrochloride Chemical class 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000030136 gastric emptying Effects 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
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- 229940068196 placebo Drugs 0.000 description 1
- 239000000902 placebo Substances 0.000 description 1
- 229940057838 polyethylene glycol 4000 Drugs 0.000 description 1
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- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000007613 slurry method Methods 0.000 description 1
- 235000015424 sodium Nutrition 0.000 description 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Classifications
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
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- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61K47/40—Cyclodextrins; Derivatives thereof
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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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
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- A—HUMAN NECESSITIES
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
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- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Biochemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
原辅料名称 | mg/片 | 处方占比% |
规格 | 20 | N/A |
盐酸决奈达隆包合物 | 163.4 | 32.7% |
乳糖 | 191.6 | 38.3% |
预胶化淀粉 | 60.0 | 12.0% |
交联聚维酮 | 50.0 | 10.0% |
胶体二氧化硅 | 20.0 | 4.0% |
氢化蓖麻油 | 15.0 | 3.0% |
欧巴代 | 15.0 | 3.0% |
总重 | 515.0 | 100% |
原辅料名称 | 作用 | 单片(mg) | 百分比% |
盐酸绝奈达隆 | API | 20.00 | 10.53 |
羟丙基-β环糊精 | 增溶剂 | 99.19 | 52.21 |
普鲁兰多糖 | 赋形剂 | 3.33 | 1.75 |
右旋糖酐 | 填充剂 | 66.67 | 35.09 |
甜菊糖苷 | 矫味剂 | 0.50 | 0.26 |
阿司帕坦 | 矫味剂 | 0.03 | 0.02 |
片重mg | / | 190 | 100.00 |
原辅料名称 | 作用 | 单片(mg) | 百分比% |
盐酸绝奈达隆 | API | 20.00 | 10.53 |
羟丙基-β环糊精 | 增溶剂 | 99.19 | 52.21 |
普鲁兰多糖 | 赋形剂 | 3.33 | 1.75 |
右旋糖酐 | 填充剂 | 66.67 | 35.09 |
吐温80 | 促渗剂 | 0.20 | 0.11 |
甜菊糖苷 | 矫味剂 | 0.50 | 0.26 |
阿司帕坦 | 矫味剂 | 0.03 | 0.02 |
片重mg | / | 190 | 100.00 |
原辅料名称 | 作用 | 单片(mg) | 百分比% |
盐酸绝奈达隆 | API | 18.00 | 13.07 |
磺丁基-β环糊精钠 | 增溶剂 | 111.48 | 80.96 |
普鲁兰多糖 | 赋形剂 | 3.00 | 2.18 |
甜菊糖苷 | 填充剂 | 3.00 | 2.18 |
阿司帕坦 | 矫味剂 | 0.06 | 0.04 |
枸橼酸 | 矫味剂 | 2.00 | 1.45 |
吐温80 | 促渗剂 | 0.15 | 0.11 |
片重mg | / | 138 | 100 |
原辅料名称 | 作用 | 单片(mg) | 百分比% |
盐酸绝奈达隆 | API | 25.00 | 13.07 |
磺丁基-β环糊精钠 | 增溶剂 | 154.82 | 80.96 |
普鲁兰多糖 | 赋形剂 | 4.17 | 2.18 |
甜菊糖苷 | 矫味剂 | 4.17 | 2.18 |
阿司帕坦 | 矫味剂 | 0.08 | 0.04 |
枸橼酸 | 矫味剂 | 2.78 | 1.45 |
吐温80 | 促渗剂 | 0.21 | 0.11 |
片重mg | / | 191 | 100.00 |
Claims (24)
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CN202011121736 | 2020-10-20 | ||
CN2020111217366 | 2020-10-20 | ||
CN202110889937 | 2021-08-04 | ||
CN2021108899379 | 2021-08-04 |
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CN114377148A CN114377148A (zh) | 2022-04-22 |
CN114377148B true CN114377148B (zh) | 2023-09-29 |
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CN202111223181.0A Active CN114377148B (zh) | 2020-10-20 | 2021-10-20 | 盐酸决奈达隆药物组合物、其制备方法及应用 |
Country Status (3)
Country | Link |
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CN (1) | CN114377148B (zh) |
TW (1) | TW202227049A (zh) |
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1479610A (zh) * | 2000-12-11 | 2004-03-03 | ʥŵ��-�ϳ�ʵ���ҹ�˾ | 肠胃道外给药的多恩达隆医药组合物 |
CN103054820A (zh) * | 2012-08-22 | 2013-04-24 | 石药集团中奇制药技术(石家庄)有限公司 | 一种盐酸决奈达隆药物组合物及其制备方法 |
CN103169691A (zh) * | 2011-12-22 | 2013-06-26 | 深圳信立泰药业股份有限公司 | 一种决奈达隆或其盐的粉末及由其制备的药物组合物 |
-
2021
- 2021-10-20 WO PCT/CN2021/124961 patent/WO2022083636A1/zh active Application Filing
- 2021-10-20 CN CN202111223181.0A patent/CN114377148B/zh active Active
- 2021-10-20 TW TW110138967A patent/TW202227049A/zh unknown
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1479610A (zh) * | 2000-12-11 | 2004-03-03 | ʥŵ��-�ϳ�ʵ���ҹ�˾ | 肠胃道外给药的多恩达隆医药组合物 |
CN103169691A (zh) * | 2011-12-22 | 2013-06-26 | 深圳信立泰药业股份有限公司 | 一种决奈达隆或其盐的粉末及由其制备的药物组合物 |
CN103054820A (zh) * | 2012-08-22 | 2013-04-24 | 石药集团中奇制药技术(石家庄)有限公司 | 一种盐酸决奈达隆药物组合物及其制备方法 |
Non-Patent Citations (4)
Title |
---|
Ana Isa P. Marcolino等.Establishment of a stability indicating HPLC method for dronedarone hydrochloride in tablets and in cyclodextrin inclusion complexes: application to degradation kinetic studies.Chemical Papers.2018,第73卷(第73期),871-881. * |
Ana Isa Pedroso Marcolino等.Comparative evaluation of the hepatotoxicity, phototoxicity and photosensitizing potential of dronedarone hydrochloride and its cyclodextrin-based inclusion complexes.Photochemical & Photobiological Sciences.2019,第18卷(第6期),1565-1575. * |
Ana Isa Pedroso Marcolino等.Preparation, characterization and in vitro cytotoxicity study of dronedarone hydrochloride inclusion complexes.Materials Science & Engineering C.2019,第100卷48-61. * |
N. Sudha等.Alteration of the Binding Strength of Dronedarone with Bovine Serum Albumin by β-Cyclodextrin: A Spectroscopic Study.Spectroscopy Letters.2014,第48卷(第48期),112-119. * |
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