CN109906077B - 依达拉奉与(+)-2-莰醇的舌下用药物组合物 - Google Patents
依达拉奉与(+)-2-莰醇的舌下用药物组合物 Download PDFInfo
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- CN109906077B CN109906077B CN201780048512.7A CN201780048512A CN109906077B CN 109906077 B CN109906077 B CN 109906077B CN 201780048512 A CN201780048512 A CN 201780048512A CN 109906077 B CN109906077 B CN 109906077B
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- Prior art keywords
- edaravone
- borneol
- pharmaceutical composition
- sublingual
- copovidone
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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
- A61K9/2027—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
-
- 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
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Abstract
Description
物料名称 | 用量(g) |
依达拉奉 | 30 |
(+)-2-莰醇 | 1.5 |
乳糖 | 39.7 |
羟丙甲纤 | 4 |
维素交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 30 |
(+)-2-莰醇 | 2 |
乳糖 | 39.2 |
羟丙甲纤 | 4 |
维素交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 1.5 |
(+)-2-莰醇 | 30 |
乳糖 | 39.7 |
羟丙甲纤 | 4 |
维素交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 6 |
(+)-2-莰醇 | 30 |
倍他环糊 | 35.2 |
精乳糖 | 10 |
羟丙甲纤 | 4 |
维素交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 40 |
(+)-2-莰醇 | 8 |
倍他环糊 | 23.2 |
精乳糖 | 10 |
羟丙甲纤 | 4 |
维素交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 50 |
(+)-2-莰醇 | 5 |
甘露醇 | 16.2 |
共聚维酮 | 4 |
交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 30 |
(+)-2-莰醇 | 6 |
甘露醇 | 14 |
乳糖 | 22.2 |
共聚维酮 | 3 |
交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 30 |
(+)-2-莰醇 | 6 |
甘露醇 | 6 |
乳糖 | 29.2 |
共聚维酮 | 4 |
交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 30 |
(+)-2-莰醇 | 6 |
乳糖 | 31.2 |
共聚维酮 | 8 |
交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 30 |
(+)-2-莰醇 | 6 |
甘露醇 | 14 |
微晶纤维 | 22.2 |
素共聚维酮 | 3 |
交联羧甲 | 4 |
基纤硬维素脂钠酸镁 | 0.8 |
物料名称 | 用量(g) |
依达拉奉 | 30 |
(+)-2-莰醇 | 6 |
甘露醇 | 14 |
微晶纤维 | 11.2 |
素共聚维酮 | 3 |
交联羧甲 | 4 |
基纤二维素氧钠化硅 | 1.1 |
硬脂酸镁 | 0.7 |
静注 | 舌下 | |
Tmax(h) | 0.033 | 2.5 |
Cmax(ng/mL) | 58550 | 4793 |
AUC<sub>0-5h</sub>(h*ng/mL) | 18179 | 15638 |
MRTlast(h) | 0.59 | 2.06 |
F(%) | / | 62.6 |
静注 | 舌下 | |
Tmax(h) | 0.033 | 0.25 |
Cmax(ng/mL) | 1405 | 55.3 |
AUC<sub>0-5h</sub>(h*ng/mL) | 270 | 106 |
MRTlast(h) | 0.20 | 1.18 |
F(%) | / | 28.5 |
静注 | 舌下 | |
Tmax(h) | 0.033 | 1.00 |
Cmax(ng/mL) | 1611 | 105 |
AUC<sub>0-5h</sub>(h*ng/mL) | 622 | 353 |
MRTlast(h) | 0.64 | 1.86 |
F(%) | / | 51.6 |
静注 | 舌下 | |
Tmax(h) | 0.033 | 0.5 |
Cmax(ng/mL) | 5726 | 260 |
AUC<sub>0-5h</sub>(h*ng/mL) | 1686 | 529 |
MRTlast(h) | 0.34 | 1.31 |
F(%) | / | 28.5 |
组别 | 动物数 | 神经缺陷症状评分 |
模型组 | 12 | 2.58±0.51 |
复方依达拉奉组 | 13 | 1.77±0.93* |
舌下片(0.8mg) | 14 | 2.00±0.68* |
舌下片(2.4mg) | 12 | 1.75±0.75** |
舌下片(7.2mg) | 13 | 1.54±1.05** |
组别 | 动物数 | 脑梗面积(%) |
模型组 | 12 | 35.1±11.5 |
复方依达拉奉组 | 13 | 22.9±13.0* |
舌下片(0.8mg) | 14 | 24.0±10.0* |
舌下片(2.4mg) | 12 | 22.0±11.4* |
舌下片(7.2mg) | 13 | 20.7±13.1** |
静注 | 舌下 | |
Tmax(h) | 0.032 | 0.5 |
Cmax(ng/mL) | 56370 | 5875 |
AUC<sub>0-5h</sub>(h*ng/mL) | 16038 | 17427 |
MRTlast(h) | 0.59 | 2.63 |
F(%) | / | 79.9 |
静注 | 舌下 | |
Tmax(h) | 0.032 | 0.25 |
Cmax(ng/mL) | 1398 | 59.2 |
AUC<sub>0-5h</sub>(h*ng/mL) | 255 | 110 |
MRTlast(h) | 0.20 | 1.16 |
F(%) | / | 30.1 |
静注 | 舌下 | |
Tmax(h) | 0.032 | 1.00 |
Cmax(ng/mL) | 1571 | 114 |
AUC<sub>0-5h</sub>(h*ng/mL) | 593 | 392 |
MRTlast(h) | 0.63 | 1.93 |
F(%) | / | 60.1 |
静注 | 舌下 | |
Tmax(h) | 0.032 | 0.5 |
Cmax(ng/mL) | 5430 | 273 |
AUC<sub>0-5h</sub>(h*ng/mL) | 1729 | 541 |
MRTlast(h) | 0.34 | 1.30 |
F(%) | / | 29.6 |
组别 | 动物数 | 脑梗面积(%) |
模型组 | 11 | 37.2±12.3 |
复方依达拉奉组 | 12 | 21.6±12.5* |
舌下片(0.8mg) | 14 | 23.4±9.3* |
舌下片(2.4mg) | 14 | 21.3±8.5* |
舌下片(7.2mg) | 13 | 19.8±10.1** |
Claims (11)
Applications Claiming Priority (3)
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CN2016107618907 | 2016-08-29 | ||
CN201610761890.7A CN107773545A (zh) | 2016-08-29 | 2016-08-29 | 依达拉奉与(+)‑2‑莰醇的舌下用药物组合物 |
PCT/CN2017/098620 WO2018040989A1 (zh) | 2016-08-29 | 2017-08-23 | 依达拉奉与(+)-2-莰醇的舌下用药物组合物 |
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CN109906077A CN109906077A (zh) | 2019-06-18 |
CN109906077B true CN109906077B (zh) | 2020-02-07 |
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CN201610761890.7A Pending CN107773545A (zh) | 2016-08-29 | 2016-08-29 | 依达拉奉与(+)‑2‑莰醇的舌下用药物组合物 |
CN201780048512.7A Active CN109906077B (zh) | 2016-08-29 | 2017-08-23 | 依达拉奉与(+)-2-莰醇的舌下用药物组合物 |
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US (1) | US11135199B2 (zh) |
EP (1) | EP3505161B1 (zh) |
JP (1) | JP6751475B2 (zh) |
KR (1) | KR102216381B1 (zh) |
CN (2) | CN107773545A (zh) |
AU (1) | AU2017317950B2 (zh) |
CA (1) | CA3037089C (zh) |
RU (1) | RU2720204C1 (zh) |
WO (1) | WO2018040989A1 (zh) |
ZA (1) | ZA201901866B (zh) |
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CN109431966B (zh) * | 2018-04-27 | 2020-09-22 | 首都医科大学附属北京天坛医院 | 依达拉奉药物组合物 |
BR112022000914A2 (pt) * | 2019-07-18 | 2022-03-08 | Bdr Pharmaceuticals International Private Ltd | Composição farmacêutica |
WO2022007831A1 (zh) * | 2020-07-08 | 2022-01-13 | 先声药业有限公司 | 一种组合物的医药用途 |
AU2021329765A1 (en) * | 2020-08-17 | 2023-03-09 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Stable pharmaceutical composition |
CN114099500B (zh) * | 2020-08-26 | 2023-09-22 | 上海云晟研新生物科技有限公司 | 依达拉奉缓释药物组合物、制备方法及应用 |
CN112426433B (zh) * | 2020-12-23 | 2022-08-05 | 湖南中医药大学 | 一种抗脑缺血炎症反应的冰片当归多糖脂质体及制备方法 |
WO2022192477A1 (en) * | 2021-03-10 | 2022-09-15 | Giri Rajan Shobhanath | Compounds for treating conditions related to oxidative stress |
WO2023078325A1 (zh) * | 2021-11-08 | 2023-05-11 | 南京宁丹新药技术有限公司 | 一种含有依达拉奉右莰醇组合物在治疗认知障碍中的应用 |
WO2024038471A1 (en) * | 2022-08-18 | 2024-02-22 | Bdr Pharmaceuticals International Private Limited | Oral formulations of edaravone and improved method of manufacturing thereof |
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ES2038696T3 (es) | 1986-03-10 | 1996-07-16 | Burghart Kurt | Procedimiento para producir un preparado farmaceutico. |
IE60601B1 (en) | 1986-08-27 | 1994-07-27 | Chugai Pharmaceutical Co Ltd | Therapeutic agent for the treatment of disorders associated with cerebral ischemia |
KR950010727B1 (ko) * | 1993-06-10 | 1995-09-22 | 엘지전선주식회사 | 전력케이블 시험용 단말장치 |
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