CN102349889A - 一种含有决奈达隆的组合物 - Google Patents
一种含有决奈达隆的组合物 Download PDFInfo
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- CN102349889A CN102349889A CN201110340013XA CN201110340013A CN102349889A CN 102349889 A CN102349889 A CN 102349889A CN 201110340013X A CN201110340013X A CN 201110340013XA CN 201110340013 A CN201110340013 A CN 201110340013A CN 102349889 A CN102349889 A CN 102349889A
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- dronedarone
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- ZQTNQVWKHCQYLQ-UHFFFAOYSA-N dronedarone Chemical compound C1=CC(OCCCN(CCCC)CCCC)=CC=C1C(=O)C1=C(CCCC)OC2=CC=C(NS(C)(=O)=O)C=C12 ZQTNQVWKHCQYLQ-UHFFFAOYSA-N 0.000 title claims abstract description 32
- 229960002084 dronedarone Drugs 0.000 title claims abstract description 32
- 239000000203 mixture Substances 0.000 title abstract description 31
- 238000002360 preparation method Methods 0.000 claims abstract description 15
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 13
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- 150000003839 salts Chemical class 0.000 claims abstract description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 18
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- 239000002253 acid Substances 0.000 claims description 9
- JLPULHDHAOZNQI-ZTIMHPMXSA-N 1-hexadecanoyl-2-(9Z,12Z-octadecadienoyl)-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/C\C=C/CCCCC JLPULHDHAOZNQI-ZTIMHPMXSA-N 0.000 claims description 8
- 229940083466 soybean lecithin Drugs 0.000 claims description 8
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims description 6
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- ITPDYQOUSLNIHG-UHFFFAOYSA-N Amiodarone hydrochloride Chemical class [Cl-].CCCCC=1OC2=CC=CC=C2C=1C(=O)C1=CC(I)=C(OCC[NH+](CC)CC)C(I)=C1 ITPDYQOUSLNIHG-UHFFFAOYSA-N 0.000 description 4
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Images
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- Medicinal Preparation (AREA)
Abstract
Description
成分 | mg | % |
盐酸决奈达隆 | 426(相当于决奈达隆400mg) | 65.5 |
微晶纤维素 | 94 | 14.5 |
乳糖 | 27 | 4.2 |
枸橼酸 | 4 | 0.62 |
共聚维酮S630 | 20 | 3 |
低取代羟丙纤维素 | 32.5 | 5 |
蛋黄卵磷脂 | 40 | 6.2 |
二氧化硅 | 3.25 | 0.5 |
硬脂酸镁 | 3.25 | 0.5 |
纯化水 | 适量(在工艺过程中除去) | |
总计 | 650 | 100 |
成分 | mg | % |
盐酸决奈达隆 | 426(相当于决奈达隆400mg) | 42.6 |
微晶纤维素 | 339 | 33.9 |
枸橼酸 | 40 | 4 |
羟丙甲纤维素 | 80 | 8 |
交联羧甲基纤维素钠 | 80 | 8 |
蛋黄卵磷脂 | 2 | 2 |
二氧化硅 | 5 | 0.5 |
硬脂酸镁 | 10 | 1 |
总计 | 1000 | 100 |
成分 | mg | % |
盐酸决奈达隆 | 426(相当于决奈达隆400mg) | 65.54 |
微晶纤维素 | 65 | 10 |
乳糖 | 30.29 | 4.66 |
酒石酸 | 19.5 | 3 |
羟丙甲纤维素 | 65 | 10 |
交联聚维酮 | 32.5 | 5 |
大豆卵磷脂 | 5.2 | 0.8 |
二氧化硅 | 3.25 | 0.5 |
硬脂酸镁 | 3.25 | 0.5 |
5%羟丙甲纤维素水溶液 | 适量(水在工艺过程中除去) | |
总计 | 650 | 100 |
成分 | mg | % |
盐酸决奈达隆 | 426(相当于决奈达隆400mg) | 65.54 |
微晶纤维素 | 130 | 20 |
乳糖 | 55 | 8.46 |
交联聚维酮 | 32.5 | 5 |
二氧化硅 | 3.25 | 0.5 |
硬脂酸镁 | 3.25 | 0.5 |
纯化水 | 适量(在工艺过程中除去) | |
总计 | 650 | 100 |
成分 | mg | % |
盐酸决奈达隆 | 426(相当于决奈达隆400mg) | 65.54 |
微晶纤维素 | 130 | 20 |
乳糖 | 49.8 | 7.66 |
交联羧聚维酮 | 32.5 | 5 |
大豆卵磷脂 | 5.2 | 0.8 |
二氧化硅 | 3.25 | 0.5 |
硬脂酸镁 | 3.25 | 0.5 |
纯化水 | 适量(在工艺过程中除去) | |
总计 | 650 | 100 |
成分 | mg | % |
盐酸决奈达隆 | 426(相当于决奈达隆400mg) | 65.54 |
微晶纤维素 | 78 | 12 |
乳糖 | 36.8 | 5.66 |
羟丙甲纤维素 | 65 | 10 |
交联聚维酮 | 32.5 | 5 |
大豆卵磷脂 | 5.2 | 0.8 |
二氧化硅 | 3.25 | 0.5 |
硬脂酸镁 | 3.25 | 0.5 |
纯化水 | 适量(在工艺过程中除去) | |
总计 | 650 | 100 |
Tmax(h) | Cmax(ng/ml) | AUC(0-t)(hr*ng/ml) | |
实施例3禁食 | 3.33 | 220.28 | 2118 |
实施例3进食 | 2.0 | 238.63 | 2027 |
Claims (10)
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CN102349889A true CN102349889A (zh) | 2012-02-15 |
CN102349889B CN102349889B (zh) | 2013-08-28 |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
CN105412027A (zh) * | 2015-11-13 | 2016-03-23 | 青岛市海慈医疗集团 | 一种盐酸决奈达隆片剂的制备方法 |
CN108042489A (zh) * | 2017-12-19 | 2018-05-18 | 佛山市弘泰药物研发有限公司 | 一种盐酸决奈达隆自微乳制剂及其制备方法 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1267217A (zh) * | 1997-06-23 | 2000-09-20 | 萨诺菲-合成实验室公司 | 含苯并呋喃衍生物的固体药物组合物 |
CN101152154A (zh) * | 2006-09-29 | 2008-04-02 | 北京德众万全药物技术开发有限公司 | 盐酸决奈达隆口服药物组合物及其制备方法 |
CN102188417A (zh) * | 2010-03-19 | 2011-09-21 | 江苏恒瑞医药股份有限公司 | 决奈达隆药物组合物 |
WO2011132167A1 (en) * | 2010-04-21 | 2011-10-27 | Sanofi-Aventis | Method for preparing pharmaceutical compositions intended for oral administration comprising one or more active ingredients and the compositions comprising same |
-
2011
- 2011-11-01 CN CN 201110340013 patent/CN102349889B/zh active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1267217A (zh) * | 1997-06-23 | 2000-09-20 | 萨诺菲-合成实验室公司 | 含苯并呋喃衍生物的固体药物组合物 |
CN101152154A (zh) * | 2006-09-29 | 2008-04-02 | 北京德众万全药物技术开发有限公司 | 盐酸决奈达隆口服药物组合物及其制备方法 |
CN102188417A (zh) * | 2010-03-19 | 2011-09-21 | 江苏恒瑞医药股份有限公司 | 决奈达隆药物组合物 |
WO2011132167A1 (en) * | 2010-04-21 | 2011-10-27 | Sanofi-Aventis | Method for preparing pharmaceutical compositions intended for oral administration comprising one or more active ingredients and the compositions comprising same |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
CN105412027A (zh) * | 2015-11-13 | 2016-03-23 | 青岛市海慈医疗集团 | 一种盐酸决奈达隆片剂的制备方法 |
CN105412027B (zh) * | 2015-11-13 | 2018-10-26 | 青岛市海慈医疗集团 | 一种盐酸决奈达隆片剂的制备方法 |
CN108042489A (zh) * | 2017-12-19 | 2018-05-18 | 佛山市弘泰药物研发有限公司 | 一种盐酸决奈达隆自微乳制剂及其制备方法 |
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