CN107519159A - 复方组合物 - Google Patents
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Abstract
一种用于缓解疼痛和/或炎症的静脉内给药组合物，所述组合物包含联合施用给人的布洛芬和对乙酰氨基酚，其中每剂量的所述组合物包含a)约125mg至约150mg布洛芬与约475mg至约525mg对乙酰氨基酚的组合；或b)约275mg至约325mg布洛芬与约975mg至约1025mg对乙酰氨基酚的组合。
Description
本申请是申请日为2011年10月26日，优先权日为2010年11月4日，申请号为201180052565.9，名称为“复方组合物”的中国发明专利申请的分案申请。
技术领域
本发明涉及含有对乙酰氨基酚和布洛芬的复方组合物。本发明的一个特别优选的实施方案涉及用于缓解疼痛和/或炎症的含有这些有效成分的复方组合物。
背景技术
对乙酰氨基酚和布洛芬的联合使用是已知的，例如含有150mg布洛芬以及500mg对乙酰氨基酚的相对低剂量的片剂。然而，需要一种特别是可在医院环境下静脉内给药的药物。本发明的一个实施方案的一个目的是至少在某种程度上促进实现这种药物。
定义
本说明书中所称的“成人”是指体重50公斤以上的人。
本说明书中所称的“儿童”是指体重低于50公斤的人。
虽然本说明书中特定提及的是布洛芬和对乙酰氨基酚，但是这两种活性成分的合适的其它药学上可接受的形式(例如盐等)也可以使用并且旨在通过提及该活性成分本身而被包括在权利要求中，只是根据重量进行相应的调整。例如，当使用盐形式时，可包含足够量以满足化合物本身所需的量(例如，513mg布洛芬赖氨酸盐或553mg布洛芬精氨酸盐相当于300mg布洛芬)。因此，举例来说，提及300mg布洛芬可解释为足以包括治疗相当量的布洛芬赖氨酸盐或布洛芬精氨酸盐。
术语“包括”及其衍生词例如“包含”在用于涉及特征组合时，不应排除该组合具有其它未指明特征的可能性。
发明内容
根据本发明的一个方面，提供一种用于缓解疼痛和/或炎症的静脉内给药组合物，该组合物含有联合施用给人的布洛芬和对乙酰氨基酚，其中每剂量的所述组合物包含：
a)约125mg至约175mg布洛芬与约475mg至约525mg对乙酰氨基酚的组合；或
b)约275mg至约325mg布洛芬与约975mg至约1025mg对乙酰氨基酚的组合。
优选地，所述组合物用于以约每6小时为基准给药。
优选地，所述组合物包含：
a)约150mg布洛芬与约500mg对乙酰氨基酚的组合；或
b)约300mg布洛芬与1000mg对乙酰氨基酚的组合。
优选地，所述组合物为溶液形式。
本发明的再一个方面包括对乙酰氨基酚和布洛芬在制造用于治疗人的疼痛和/或炎症的静脉内药物中的应用，其中所述药物以每剂量基准包含：
a)约125mg至约175mg布洛芬与约475mg至约525mg对乙酰氨基酚的组合；
b)约275mg至约325mg布洛芬与约975mg至约1025mg对乙酰氨基酚的组合。
优选地，所述组合物用于以约每6小时为基准给药。
优选地，所述组合物包含：
a)约150mg布洛芬与约500mg对乙酰氨基酚的组合；或
b)约300mg布洛芬与1000mg对乙酰氨基酚的组合。
优选地，所述组合物为溶液形式。
本发明的再一个方面包括通过对人静脉内施用药物来治疗疼痛和/或炎症的方法，所述药物包含：
a)约125mg至约175mg布洛芬与约475mg至约525mg对乙酰氨基酚的组合；
b)约275mg至约325mg布洛芬与约975mg至约1025mg对乙酰氨基酚的组合。
优选地，该组合物用于以6小时为基准给药。
优选地，该组合物包含：
a)约150mg布洛芬与约500mg对乙酰氨基酚的组合；或
b)约300mg布洛芬与1000mg对乙酰氨基酚的组合。
优选地，所述组合物为溶液形式。
具体实施方式
在本发明的一个优选实施方案中，提供一种静脉内给药溶液用于治疗人类患者的疼痛或炎症。该溶液是一种复方药物，包含布洛芬、对乙酰氨基酚和适宜的赋形剂，所述赋形剂是配制静脉内给药药物领域的普通技术人员所公知的。所述赋形剂可包括合适的抗氧化剂、pH调节剂、缓冲剂、等渗剂和纯化水。
下面的实施例说明静脉输注液形式的本发明优选实施方案。
对于每一个上述实施例，两种活性成分均与合适的标准赋形剂混合，以得到如上所示的小瓶容量。
输注液以完整剂量为患者给药，例如，在每一种情况下，病人每6小时接受完整小瓶内容物的15分钟输注。实施例1是儿童剂量，实施例2是成人剂量。对于非常年轻或年幼的儿童，可以与处方医生的医嘱相匹配地按照体重仅给予部分小瓶内容物的剂量。
每24小时4000mg对乙酰氨基酚以每6小时4次1000mg剂量给药长期以来被认为足够缓解低水平的疼痛，但是对于遭受剧烈疼痛的患者，例如在某些手术后的情况下，这种剂量是不够的。然而，通常不建议对乙酰氨基酚的剂量超过每剂量1000mg或每24小时周期超过4000mg，因为这样做可能会导致不良副作用。
已知使用每8小时800mg布洛芬的剂量来治疗剧烈疼痛。然而，高达800mg的剂量会导致不良副作用，例如心肺功能不良、肾功能问题、血栓风险和胃肠道出血。降低单次给药的布洛芬量可以减少副作用的风险，但同时会导致疼痛缓解作用显著下降。
出乎意料的是，每6小时使用分别含有150mg至300mg布洛芬以及500mg至1000mg对乙酰氨基酚的静脉内给药药物对于某些患者提供了足够的疼痛缓解，否则这些患者将需要每8小时分别给药400mg或800mg布洛芬。较低剂量的布洛芬对于部分患者减少了不良副作用的风险，但是该药物对这些患者的效果不会因对乙酰氨基酚的存在而减弱。这是出人意料的，因为不能预见到对乙酰氨基酚的存在对许多患者能起到任何显著程度的益处。这种联合施用是违背常识的，因为例如用于缓解疼痛的400mg布洛芬一般被视为每8小时药剂，而1000mg对乙酰氨基酚通常被视为每6小时药剂。这些活性成分的正常剂量方案是彼此不同步的，即每8小时对每6小时，因此本领域普通技术人员不会将本发明的剂量视作合适的复方药物。
类似的考虑也适用于150mg布洛芬与500mg对乙酰氨基酚联合施用以治疗遭受疼痛的儿童。在这方面，出乎意料的是，通常给予200mg布洛芬来缓解疼痛的一些儿童可作为替代地被给予150mg布洛芬与500mg对乙酰氨基酚的组合。
在持续进行的基础上，例如每6小时，对成人给予包含300mg布洛芬和1000mg对乙酰氨基酚的并用静脉内给药溶液或者对儿童给予包含150mg布洛芬和500mg对乙酰氨基酚的并用静脉内给药溶液，相对于相同剂量的口服给药例如口服片剂方式而言，提供了出乎意料的疼痛缓解水平。静脉内给药至少对于从外科手术中恢复的一些患者减少了对缓解疼痛进行救援的需要。静脉内给药可以是例如通过注射或输注进行。
实施例3
在本发明的一个特定实施方案中，静脉内给药溶液可以通过以下活性成分和赋形剂的混合制备：
| 活性成分 | 用量 |
| 对乙酰氨基酚 | 1000mg |
| 布洛芬精氨酸盐 | 553mg |
| 赋形剂 | 用量 |
| 还原型谷胱甘肽(作为抗氧化剂) | 20mg |
| 氢氧化钠或盐酸(作为pH调节剂) | 足以得到5-6的pH值 |
| 柠檬酸钠(作为缓冲剂) | 10mg |
| 氯化钠(作为等渗剂) | 足够赋予等渗性 |
| 纯化水 | 足够将组合物补充至100ml |
根据需要并与处方医生的医嘱相匹配，将该溶液作为单次静脉内给药剂量和其它等同剂量对成人给药。
实施例4
在本发明的另一实施方案中，静脉内给药溶液可以通过以下活性成分和赋形剂的混合制备：
根据需要并与处方医生的医嘱相匹配，将该溶液作为单次静脉内给药剂量和其它等同剂量对儿童给药。
虽然已经通过举例方式描述了本发明的一些优选形式，但应当理解的是可在不偏离以下权利要求的范围内进行修改和改进。
Claims (8)
1.一种用于缓解疼痛和/或炎症的静脉内给药组合物，所述组合物包含联合施用给人的布洛芬和对乙酰氨基酚，其中每剂量的所述组合物包含：
a)125mg至150mg布洛芬与475mg至525mg对乙酰氨基酚的组合；或
b)275mg至325mg布洛芬与975mg至1025mg对乙酰氨基酚的组合。
2.如权利要求1所述的组合物，所述组合物用于以每6小时为基准给药。
3.如权利要求1或2所述的组合物，包含：
a)150mg布洛芬与500mg对乙酰氨基酚的组合；或
b)300mg布洛芬与1000mg对乙酰氨基酚的组合。
4.如权利要求1或2或3所述的组合物，其中所述组合物为溶液形式。
5.一种对乙酰氨基酚和布洛芬在制造用于治疗人的疼痛和/或炎症的静脉内药物中的应用，其中所述药物以每剂量基准包含：
a)125mg至175mg布洛芬与475mg至525mg对乙酰氨基酚的组合；
b)275mg至325mg布洛芬与975mg至1025mg对乙酰氨基酚的组合。
6.如权利要求5所述的应用，其中所述组合物用于以每6小时为基准给药。
7.如权利要求5或6所述的应用，其中所述组合物包含：
a)150mg布洛芬与500mg对乙酰氨基酚的组合；或
b)300mg布洛芬与1000mg对乙酰氨基酚的组合。
8.如权利要求5或6或7所述的应用，其中所述组合物为溶液形式。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| NZ58901110 | 2010-11-04 | ||
| NZ589011 | 2010-11-04 | ||
| CN2011800525659A CN103298464A (zh) | 2010-11-04 | 2011-10-26 | 复方组合物 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011800525659A Division CN103298464A (zh) | 2010-11-04 | 2011-10-26 | 复方组合物 |
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| Publication Number | Publication Date |
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| CN107519159A true CN107519159A (zh) | 2017-12-29 |
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| CN2011800525659A Pending CN103298464A (zh) | 2010-11-04 | 2011-10-26 | 复方组合物 |
| CN201710623266.5A Pending CN107519159A (zh) | 2010-11-04 | 2011-10-26 | 复方组合物 |
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| CN2011800525659A Pending CN103298464A (zh) | 2010-11-04 | 2011-10-26 | 复方组合物 |
Country Status (27)
| Country | Link |
|---|---|
| US (5) | US20130225685A1 (zh) |
| EP (1) | EP2635269B1 (zh) |
| JP (2) | JP2013541583A (zh) |
| KR (1) | KR101900520B1 (zh) |
| CN (2) | CN103298464A (zh) |
| AU (1) | AU2011324137B2 (zh) |
| BR (1) | BR112013010829B8 (zh) |
| CA (1) | CA2814057C (zh) |
| CL (1) | CL2013001250A1 (zh) |
| CO (1) | CO6771406A2 (zh) |
| CY (1) | CY1123398T1 (zh) |
| DK (1) | DK2635269T3 (zh) |
| ES (1) | ES2742373T3 (zh) |
| HR (1) | HRP20191489T1 (zh) |
| HU (1) | HUE045442T2 (zh) |
| LT (1) | LT2635269T (zh) |
| MX (2) | MX2013005113A (zh) |
| MY (1) | MY160572A (zh) |
| NZ (1) | NZ609727A (zh) |
| PH (1) | PH12021550804A1 (zh) |
| PL (1) | PL2635269T3 (zh) |
| PT (1) | PT2635269T (zh) |
| RS (1) | RS59258B1 (zh) |
| RU (2) | RU2013123646A (zh) |
| SG (1) | SG189319A1 (zh) |
| SI (1) | SI2635269T1 (zh) |
| WO (1) | WO2012060719A1 (zh) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2013005113A (es) | 2010-11-04 | 2013-06-03 | Aft Pharmaceuticals Ltd | Una composicion combinada. |
| US9072710B2 (en) | 2012-03-16 | 2015-07-07 | Cumberland Pharmaceuticals Inc. | Injectable ibuprofen formulation |
| WO2016008546A1 (en) * | 2014-07-18 | 2016-01-21 | Everbright Pharmaceuticals S.A.R.L. | Aqueous formulation comprising paracetamol and ibuprofen |
| EP3203996A4 (en) * | 2014-10-06 | 2018-05-16 | Cumberland Pharmaceuticals, Inc. | Co-administration of intravenous ibuprofen and acetaminophen for treatment of pain |
| WO2018192664A1 (en) | 2017-04-20 | 2018-10-25 | Hyloris Developments Sa | METHOD FOR PREPARING A COMPOSITION WITH A LOW DISSOLVED OXYGEN CONTENT, COMPRISING ACETAMINOPHEN, AND OPTIONALLY ONE OR MORE NSAIDs, AND A COMPOSITION OBTAINED THEREOF |
| US10376471B2 (en) * | 2017-07-10 | 2019-08-13 | Gel Cap Technologies, LLC | Dual release dosage form capsule and methods, devices and systems for making same |
| US11197830B2 (en) | 2019-02-27 | 2021-12-14 | Aft Pharmaceuticals Limited | Pharmaceutical composition containing acetaminophen and ibuprofen |
| US11568752B2 (en) * | 2020-01-28 | 2023-01-31 | David Clark Company Incorporated | Gateway retrieval alert device for aircraft pushback operations |
| WO2023281089A2 (en) | 2021-07-08 | 2023-01-12 | Krka, D.D., Novo Mesto | Pharmaceutical composition comprising naproxen and paracetamol |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101022789A (zh) * | 2004-07-07 | 2007-08-22 | Aft制药有限公司 | 一种药物组合物 |
| KR20080072839A (ko) * | 2005-10-13 | 2008-08-07 | 알코아 인코포레이티드 | 용융 알루미늄 고압 압출 장치 및 방법 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1997020551A1 (en) * | 1995-12-05 | 1997-06-12 | Adcock Ingram Limited | Pharmaceutical composition comprising a skeletal muscle relaxant, a non-steroidal antiinflammatory agent and an analgesic |
| CA2462452C (en) * | 2001-11-02 | 2006-07-04 | Leo Pavliv | Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid |
| BR0318201A (pt) * | 2003-03-21 | 2006-03-21 | Mcneil Ppc Inc | regime de dosagem de fármaco antiinflamatório não-esteroidal |
| KR20060072839A (ko) * | 2004-12-23 | 2006-06-28 | 김경태 | 아세트아미노펜과 이부프로펜을 이용하여 통증조절과 해열작용을 하는 주사제 |
| US8580855B2 (en) * | 2006-10-20 | 2013-11-12 | Mcneil-Ppc, Inc. | Acetaminophen / ibuprofen combinations and method for their use |
| WO2008079818A2 (en) * | 2006-12-21 | 2008-07-03 | Soluprin Pharmaceuticals, Inc. | Intravenous administration of water soluble analgesic formulations |
| US20090264530A1 (en) * | 2008-04-16 | 2009-10-22 | Nickell Robert P | Combined nsaid and acetaminophen formulation and method |
| PL2341900T3 (pl) * | 2008-10-14 | 2019-08-30 | Aft Pharmaceuticals Limited | Produkt medyczny i leczenie |
| ES2694506T3 (es) * | 2009-03-12 | 2018-12-21 | Cumberland Pharmaceuticals Inc. | Administración de ibuprofeno por vía intravenosa |
| MY164112A (en) * | 2010-07-07 | 2017-11-30 | Aft Pharmaceuticals Ltd | A combination composition comprising ibuprofen and paracetamol |
| MX2013005113A (es) | 2010-11-04 | 2013-06-03 | Aft Pharmaceuticals Ltd | Una composicion combinada. |
| EP3203996A4 (en) * | 2014-10-06 | 2018-05-16 | Cumberland Pharmaceuticals, Inc. | Co-administration of intravenous ibuprofen and acetaminophen for treatment of pain |
-
2011
- 2011-10-26 MX MX2013005113A patent/MX2013005113A/es not_active Application Discontinuation
- 2011-10-26 PT PT11838295T patent/PT2635269T/pt unknown
- 2011-10-26 NZ NZ609727A patent/NZ609727A/en unknown
- 2011-10-26 KR KR1020137014178A patent/KR101900520B1/ko active IP Right Review Request
- 2011-10-26 RU RU2013123646/15A patent/RU2013123646A/ru not_active Application Discontinuation
- 2011-10-26 AU AU2011324137A patent/AU2011324137B2/en active Active
- 2011-10-26 DK DK11838295.1T patent/DK2635269T3/da active
- 2011-10-26 LT LTEP11838295.1T patent/LT2635269T/lt unknown
- 2011-10-26 RS RSP20190963 patent/RS59258B1/sr unknown
- 2011-10-26 BR BR112013010829A patent/BR112013010829B8/pt active IP Right Grant
- 2011-10-26 JP JP2013537631A patent/JP2013541583A/ja active Pending
- 2011-10-26 CA CA2814057A patent/CA2814057C/en active Active
- 2011-10-26 EP EP11838295.1A patent/EP2635269B1/en active Active
- 2011-10-26 US US13/882,953 patent/US20130225685A1/en not_active Abandoned
- 2011-10-26 SI SI201131767T patent/SI2635269T1/sl unknown
- 2011-10-26 CN CN2011800525659A patent/CN103298464A/zh active Pending
- 2011-10-26 HU HUE11838295A patent/HUE045442T2/hu unknown
- 2011-10-26 MX MX2015008709A patent/MX367209B/es unknown
- 2011-10-26 PL PL11838295T patent/PL2635269T3/pl unknown
- 2011-10-26 CN CN201710623266.5A patent/CN107519159A/zh active Pending
- 2011-10-26 ES ES11838295T patent/ES2742373T3/es active Active
- 2011-10-26 SG SG2013026265A patent/SG189319A1/en unknown
- 2011-10-26 RU RU2015103107A patent/RU2707089C2/ru active
- 2011-10-26 WO PCT/NZ2011/000226 patent/WO2012060719A1/en active Application Filing
- 2011-10-26 MY MYPI2013001237A patent/MY160572A/en unknown
-
2013
- 2013-05-06 CL CL2013001250A patent/CL2013001250A1/es unknown
- 2013-05-22 CO CO13125952A patent/CO6771406A2/es not_active Application Discontinuation
-
2015
- 2015-08-21 US US14/832,154 patent/US20160235695A1/en not_active Abandoned
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2017
- 2017-03-22 JP JP2017055893A patent/JP6353577B2/ja active Active
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2018
- 2018-10-01 US US16/149,109 patent/US11446266B2/en active Active
-
2019
- 2019-07-18 CY CY20191100766T patent/CY1123398T1/el unknown
- 2019-08-16 HR HRP20191489 patent/HRP20191489T1/hr unknown
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2021
- 2021-04-08 PH PH12021550804A patent/PH12021550804A1/en unknown
-
2022
- 2022-09-13 US US17/943,708 patent/US11896567B2/en active Active
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2024
- 2024-01-05 US US18/405,907 patent/US20240207210A1/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101022789A (zh) * | 2004-07-07 | 2007-08-22 | Aft制药有限公司 | 一种药物组合物 |
| KR20080072839A (ko) * | 2005-10-13 | 2008-08-07 | 알코아 인코포레이티드 | 용융 알루미늄 고압 압출 장치 및 방법 |
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