CN111714449A - 含有紫杉烷-环糊精复合物的药物组合物、制造方法和使用方法 - Google Patents
含有紫杉烷-环糊精复合物的药物组合物、制造方法和使用方法 Download PDFInfo
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- CN111714449A CN111714449A CN202010727929.XA CN202010727929A CN111714449A CN 111714449 A CN111714449 A CN 111714449A CN 202010727929 A CN202010727929 A CN 202010727929A CN 111714449 A CN111714449 A CN 111714449A
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- Prior art keywords
- taxane
- liquid pharmaceutical
- cyclodextrin
- pharmaceutical composition
- povidone
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- -1 taxane compound Chemical class 0.000 claims abstract description 15
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- 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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| CN202010718622.3A Pending CN111728941A (zh) | 2015-03-16 | 2016-03-14 | 含有紫杉烷-环糊精复合物的药物组合物、制造方法和使用方法 |
| CN202010718595.XA Pending CN111728940A (zh) | 2015-03-16 | 2016-03-14 | 含有紫杉烷-环糊精复合物的药物组合物、制造方法和使用方法 |
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| CN202010718595.XA Pending CN111728940A (zh) | 2015-03-16 | 2016-03-14 | 含有紫杉烷-环糊精复合物的药物组合物、制造方法和使用方法 |
| CN201680016066.7A Active CN107427486B (zh) | 2015-03-16 | 2016-03-14 | 含有紫杉烷-环糊精复合物的药物组合物、制造方法和使用方法 |
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| CN113559277B (zh) * | 2018-01-11 | 2023-11-17 | 比卡生物科技（广州）有限公司 | 一种注射用卡巴他赛组合物及其制备方法 |
| EP3827822B1 (en) | 2018-07-25 | 2024-11-06 | Bika Biotechnology (Guangzhou) Co., Ltd. | Docetaxel composition for injection and preparation method therefor |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1879612A (zh) * | 2005-06-17 | 2006-12-20 | 上海艾力斯医药科技有限公司 | 紫杉烷环糊精包合物纳米粒及其制备方法 |
| CN101366696A (zh) * | 2008-10-16 | 2009-02-18 | 姚定全 | 一种紫杉醇的水溶性注射用药物组合物、制备方法及用途 |
| CN101484137A (zh) * | 2006-05-22 | 2009-07-15 | Sk化学株式会社 | 包含多西他赛的稳定的药物组合物及其生产方法 |
| CN102026667A (zh) * | 2008-04-18 | 2011-04-20 | 安吉奥开米公司 | 紫杉醇、紫杉醇类似物或紫杉醇结合物的药物组合物及相关制备方法和用途 |
| CN103974703A (zh) * | 2011-08-10 | 2014-08-06 | SciDose有限责任公司 | 卡巴他赛制剂及其制备方法 |
| KR20140147336A (ko) * | 2013-06-19 | 2014-12-30 | 에스케이케미칼주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
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| CN1676125A (zh) | 2004-03-31 | 2005-10-05 | 张昊 | 含有紫杉碱类或难溶药物的纳米级乳剂 |
| US20060105045A1 (en) | 2004-11-08 | 2006-05-18 | Buchanan Charles M | Cyclodextrin solubilizers for liquid and semi-solid formulations |
| CN101020059B (zh) * | 2006-02-15 | 2011-01-05 | 中国科学院上海药物研究所 | 一种含多烯紫杉醇类物质的药物组合物及其制备方法 |
| CN100486645C (zh) | 2006-09-12 | 2009-05-13 | 南京师范大学 | 含有环糊精紫杉醇包合物的药物组合物及其制备方法 |
| CN100411688C (zh) | 2006-09-12 | 2008-08-20 | 南京师范大学 | 含有环糊精/多烯紫杉醇包合物的药物组合物及其制备方法 |
| CN101439017B (zh) | 2007-11-20 | 2013-03-20 | 石茂光 | 紫杉烷类抗肿瘤药物的聚合物水溶液制剂的制备方法 |
| KR101478779B1 (ko) | 2007-11-22 | 2015-01-05 | 에스케이케미칼주식회사 | 재수화시간이 향상된 택산 유도체 함유 동결건조 조성물 및이의 제조방법 |
| KR101502533B1 (ko) | 2007-11-22 | 2015-03-13 | 에스케이케미칼주식회사 | 우수한 안정성을 갖는 택산 유도체 함유 주사제용동결건조 조성물 및 이의 제조방법 |
| CN101485652B (zh) * | 2009-02-25 | 2012-03-28 | 北京世纪博康医药科技有限公司 | 一种紫杉烷类化合物的组合物、其制备方法和用途 |
| WO2012012404A1 (en) * | 2010-07-19 | 2012-01-26 | Bayer Healthcare Llc | Drug combinations with fluoro-substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions |
| WO2012161520A2 (ko) * | 2011-05-23 | 2012-11-29 | 에스케이케미칼 주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
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Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1879612A (zh) * | 2005-06-17 | 2006-12-20 | 上海艾力斯医药科技有限公司 | 紫杉烷环糊精包合物纳米粒及其制备方法 |
| CN101484137A (zh) * | 2006-05-22 | 2009-07-15 | Sk化学株式会社 | 包含多西他赛的稳定的药物组合物及其生产方法 |
| CN102026667A (zh) * | 2008-04-18 | 2011-04-20 | 安吉奥开米公司 | 紫杉醇、紫杉醇类似物或紫杉醇结合物的药物组合物及相关制备方法和用途 |
| CN101366696A (zh) * | 2008-10-16 | 2009-02-18 | 姚定全 | 一种紫杉醇的水溶性注射用药物组合物、制备方法及用途 |
| CN103974703A (zh) * | 2011-08-10 | 2014-08-06 | SciDose有限责任公司 | 卡巴他赛制剂及其制备方法 |
| KR20140147336A (ko) * | 2013-06-19 | 2014-12-30 | 에스케이케미칼주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
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| CN107427486A (zh) | 2017-12-01 |
| EP3270912A4 (en) | 2018-11-14 |
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| US20180050116A1 (en) | 2018-02-22 |
| EP3270912B1 (en) | 2021-08-18 |
| US10398785B2 (en) | 2019-09-03 |
| JP2018512395A (ja) | 2018-05-17 |
| CN107427486B (zh) | 2020-07-10 |
| CN111728941A (zh) | 2020-10-02 |
| PL3270912T3 (pl) | 2022-04-19 |
| CN111728940A (zh) | 2020-10-02 |
| WO2016149162A1 (en) | 2016-09-22 |
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