CN107213130B - 一种恩替卡韦药用组合物、制备方法及其应用 - Google Patents
一种恩替卡韦药用组合物、制备方法及其应用 Download PDFInfo
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- CN107213130B CN107213130B CN201710333110.3A CN201710333110A CN107213130B CN 107213130 B CN107213130 B CN 107213130B CN 201710333110 A CN201710333110 A CN 201710333110A CN 107213130 B CN107213130 B CN 107213130B
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- 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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- A61K31/708—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid having oxo groups directly attached to the purine ring system, e.g. guanosine, guanylic acid
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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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- 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
- A61K47/38—Cellulose; Derivatives thereof
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- 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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- A61K9/2022—Organic macromolecular compounds
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- A61K9/2806—Coating materials
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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Abstract
Description
释放度(%w/w) | 20161114-1 | 20161121-1 | 20161121-2 | 20161121-3 | 20161121-4 | 20160926-2 |
1 | 17.8 | 19.6 | 18.4 | 21.8 | 24.9 | 17.7 |
2 | 29.9 | 31.6 | 32.7 | 38.3 | 44.7 | 29.7 |
4 | 49.0 | 49.7 | 56.7 | 66.4 | 76.2 | 49.5 |
6 | 63.6 | 63.5 | 74.8 | 85.4 | 91.8 | 65.0 |
9 | 79.6 | 78.8 | 90.5 | 98.4 | 100.1 | 81.5 |
12 | 90.4 | 89.1 | 95.1 | 100.6 | 100.4 | 91.9 |
15 | 97.3 | 94.7 | 95.8 | 100.9 | 100.6 | 96.8 |
18 | 101.5 | 97.4 | 96.6 | 101.8 | 101.5 | 98.8 |
24 | 103.8 | 98.4 | 97.0 | 102.5 | 102.5 | 99.3 |
成分(mg) | 20161113-1 | 20161114-1 | 20170321-1 | 20170322-1 | 20170322-2 |
恩替卡韦一水合物 | 1.06 | 1.6 | -- | 3.2 | 4.8 |
恩替卡韦 | -- | -- | 1.5 | -- | -- |
喷雾干燥乳糖 | 20 | 20 | 20 | 20 | 20 |
微晶纤维素 | 96.94 | 96.4 | 96.5 | 94.8 | 93.2 |
羟丙甲基纤维素K15M | 80 | 80 | 80 | 80 | 80 |
硬脂酸镁 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 |
二氧化硅 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 |
总量 | 200 | 200 | 200 | 200 | 200 |
Claims (5)
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201710333110.3A CN107213130B (zh) | 2017-05-12 | 2017-05-12 | 一种恩替卡韦药用组合物、制备方法及其应用 |
PCT/US2017/056318 WO2018071654A1 (en) | 2016-10-12 | 2017-10-12 | Sustained release pharmaceutical dosage form of entecavir |
US16/382,921 US20190240143A1 (en) | 2016-10-12 | 2019-04-12 | Sustained Release Pharmaceutical Dosage Form of Entecavir |
PCT/US2020/027638 WO2020210604A1 (en) | 2017-05-12 | 2020-04-10 | Sustained release pharmaceutical dosage form of entecavir |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201710333110.3A CN107213130B (zh) | 2017-05-12 | 2017-05-12 | 一种恩替卡韦药用组合物、制备方法及其应用 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN107213130A CN107213130A (zh) | 2017-09-29 |
CN107213130B true CN107213130B (zh) | 2018-05-11 |
Family
ID=59943937
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN201710333110.3A Active CN107213130B (zh) | 2016-10-12 | 2017-05-12 | 一种恩替卡韦药用组合物、制备方法及其应用 |
Country Status (3)
Country | Link |
---|---|
US (1) | US20190240143A1 (zh) |
CN (1) | CN107213130B (zh) |
WO (2) | WO2018071654A1 (zh) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107213130B (zh) * | 2017-05-12 | 2018-05-11 | 上海奥科达生物医药科技有限公司 | 一种恩替卡韦药用组合物、制备方法及其应用 |
CN114732791B (zh) * | 2022-03-17 | 2023-09-29 | 成都倍特药业股份有限公司 | 一种含有卡麦角林的组合物及其制备方法和用途 |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1786000A (zh) * | 2005-05-23 | 2006-06-14 | 杨喜鸿 | 恩替卡韦的钠盐及其制备方法和药物应用 |
CN101028270A (zh) * | 2007-02-02 | 2007-09-05 | 广东东阳光药业有限公司 | 恩替卡韦控释片及其制备方法 |
WO2013114389A1 (en) * | 2011-12-21 | 2013-08-08 | Mylan Laboratories Limited. | Process for preparing solid oral formulations comprising low dose of entecavir |
EP2644197A1 (en) * | 2012-03-26 | 2013-10-02 | Sanovel Ilac Sanayi ve Ticaret A.S. | Novel Pharmaceutical Compositions of Entecavir |
KR101285008B1 (ko) * | 2012-04-18 | 2013-07-10 | 제일약품주식회사 | 저용량 엔테카비어의 경구투여 제제의 제조방법 |
WO2014028878A1 (en) * | 2012-08-16 | 2014-02-20 | Teva Pharmaceutical Industries Ltd. | Pharmaceutical compositions of memantine |
EP2832351A1 (en) * | 2013-07-29 | 2015-02-04 | Sanovel Ilac Sanayi ve Ticaret A.S. | Multilayer Tablet Formulations Comprising Tenofovir and Entecavir |
CN107213130B (zh) * | 2017-05-12 | 2018-05-11 | 上海奥科达生物医药科技有限公司 | 一种恩替卡韦药用组合物、制备方法及其应用 |
-
2017
- 2017-05-12 CN CN201710333110.3A patent/CN107213130B/zh active Active
- 2017-10-12 WO PCT/US2017/056318 patent/WO2018071654A1/en active Application Filing
-
2019
- 2019-04-12 US US16/382,921 patent/US20190240143A1/en not_active Abandoned
-
2020
- 2020-04-10 WO PCT/US2020/027638 patent/WO2020210604A1/en active Application Filing
Also Published As
Publication number | Publication date |
---|---|
US20190240143A1 (en) | 2019-08-08 |
WO2018071654A1 (en) | 2018-04-19 |
WO2020210604A1 (en) | 2020-10-15 |
CN107213130A (zh) | 2017-09-29 |
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Inventor after: Lu Enxian Inventor after: Li Shoufeng Inventor after: Lv Shaoqiong Inventor before: Lu Enxian Inventor before: Li Shoufeng Inventor before: Ma Hongyan Inventor before: Lv Shaoqiong Inventor before: Wang Shuo |
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Effective date of registration: 20191011 Address after: 201318 Room 301, building 2, No. 3377, Kangxin Road, Pudong New Area, Shanghai Patentee after: Shanghai Aoquan Biomedical Technology Co., Ltd. Address before: 201318, room 2, building 3377, 301, Kang Xin Road, Shanghai, Pudong New Area Patentee before: Shanghai Aucta Pharmaceuticals Co., Ltd. |
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