CN102973531A - 一种左乙拉西坦药物组合物及其制备方法 - Google Patents
一种左乙拉西坦药物组合物及其制备方法 Download PDFInfo
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- CN102973531A CN102973531A CN2012105523355A CN201210552335A CN102973531A CN 102973531 A CN102973531 A CN 102973531A CN 2012105523355 A CN2012105523355 A CN 2012105523355A CN 201210552335 A CN201210552335 A CN 201210552335A CN 102973531 A CN102973531 A CN 102973531A
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- levetiracetam
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- HPHUVLMMVZITSG-ZCFIWIBFSA-N levetiracetam Chemical compound CC[C@H](C(N)=O)N1CCCC1=O HPHUVLMMVZITSG-ZCFIWIBFSA-N 0.000 title claims abstract description 88
- 229960004002 levetiracetam Drugs 0.000 title claims abstract description 86
- 239000000203 mixture Substances 0.000 title claims abstract description 21
- 238000002360 preparation method Methods 0.000 title abstract description 17
- 239000003814 drug Substances 0.000 title abstract description 10
- 238000000034 method Methods 0.000 claims abstract description 26
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 11
- 239000000945 filler Substances 0.000 claims abstract description 11
- 239000000314 lubricant Substances 0.000 claims abstract description 9
- 238000007907 direct compression Methods 0.000 claims abstract description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 32
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 16
- 235000019359 magnesium stearate Nutrition 0.000 claims description 16
- 239000000741 silica gel Substances 0.000 claims description 14
- 229910002027 silica gel Inorganic materials 0.000 claims description 14
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 12
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 12
- 238000004132 cross linking Methods 0.000 claims description 12
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 12
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 12
- 239000000463 material Substances 0.000 claims description 8
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 7
- 239000002994 raw material Substances 0.000 claims description 7
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 6
- 238000007906 compression Methods 0.000 claims description 6
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- 239000008101 lactose Substances 0.000 claims description 6
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- 230000000052 comparative effect Effects 0.000 description 41
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- 238000006243 chemical reaction Methods 0.000 description 7
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 7
- 239000008108 microcrystalline cellulose Substances 0.000 description 7
- 229940016286 microcrystalline cellulose Drugs 0.000 description 7
- 229940079593 drug Drugs 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 5
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 description 5
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 5
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 5
- 239000002671 adjuvant Substances 0.000 description 4
- 239000001961 anticonvulsive agent Substances 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
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- 238000005516 engineering process Methods 0.000 description 2
- 206010015037 epilepsy Diseases 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- 208000017194 Affective disease Diseases 0.000 description 1
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- RWRDLPDLKQPQOW-UHFFFAOYSA-N Pyrrolidine Chemical class C1CCNC1 RWRDLPDLKQPQOW-UHFFFAOYSA-N 0.000 description 1
- 230000003556 anti-epileptic effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
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- 201000001993 idiopathic generalized epilepsy Diseases 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
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- 201000006417 multiple sclerosis Diseases 0.000 description 1
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- 238000005550 wet granulation Methods 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
原辅料名称 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 |
左乙拉西坦 | 25 | 23.4 | 35.8 | 26 | 28.4 |
低取代羟丙基纤维素 | 6.6 | 7 | 1.94 | 6 | 5.08 |
直压乳糖 | 6.6 | 7 | 1.94 | 6 | 5.08 |
交联羧甲基纤维素钠 | 0.6 | 0.8 | 0.04 | 0.8 | 0.4 |
微粉硅胶 | 0.8 | 1 | 0.04 | 0.6 | 0.72 |
硬脂酸镁 | 0.4 | 0.8 | 0.04 | 0.6 | 0.32 |
原辅料名称 | 实施例6 | 实施例7 | 实施例8 | 实施例9 | 实施例10 |
左乙拉西坦 | 25 | 23.4 | 35.8 | 26 | 28.4 |
低取代羟丙基纤维素 | 6.6 | 7 | 1.94 | 6 | 5.08 |
直压乳糖 | 6.6 | 7 | 1.94 | 6 | 5.08 |
交联羧甲基纤维素钠 | 0.6 | 0.8 | 0.04 | 0.8 | 0.4 |
微粉硅胶 | 0.8 | 1 | 0.04 | 0.6 | 0.72 |
硬脂酸镁 | 0.4 | 0.8 | 0.04 | 0.6 | 0.32 |
原辅料名称 | 实施例11 | 实施例12 | 实施例13 | 实施例14 | 实施例15 |
左乙拉西坦 | 25 | 23.4 | 35.8 | 26 | 28.4 |
低取代羟丙基纤维素 | 6.6 | 7 | 1.94 | 6 | 5.08 |
直压乳糖 | 6.6 | 7 | 1.94 | 6 | 5.08 |
交联羧甲基纤维素钠 | 0.6 | 0.8 | 0.04 | 0.8 | 0.4 |
微粉硅胶 | 0.8 | 1 | 0.04 | 0.6 | 0.72 |
硬脂酸镁 | 0.4 | 0.8 | 0.04 | 0.6 | 0.32 |
原辅料名称 | 实施例16 | 实施例17 | 实施例18 | 实施例19 | 实施例20 |
左乙拉西坦 | 25 | 23.4 | 35.8 | 26 | 28.4 |
低取代羟丙基纤维素 | 6.6 | 7 | 1.94 | 6 | 5.08 |
直压乳糖 | 6.6 | 7 | 1.94 | 6 | 5.08 |
交联羧甲基纤维素钠 | 0.6 | 0.8 | 0.04 | 0.8 | 0.4 |
微粉硅胶 | 0.8 | 1 | 0.04 | 0.6 | 0.72 |
硬脂酸镁 | 0.4 | 0.8 | 0.04 | 0.6 | 0.32 |
原辅料名称 | 对比例1 | 对比例2 | 对比例3 |
左乙拉西坦 | 50 | 25 | 50 |
微晶纤维素 | 12.5 | 2.47 | 4.56 |
交联羧甲基纤维素钠 | - | - | 1 |
交联聚维酮 | - | 1.2 | - |
共聚维酮 | - | - | 4 |
聚乙二醇6000 | - | 0.3 | - |
微粉硅胶 | - | 1 | 0.3 |
硬脂酸镁 | 0.31 | 0.03 | 0.14 |
原辅料名称 | 对比例4 | 对比例5 | 对比例6 |
左乙拉西坦 | 50 | 25 | 50 |
微晶纤维素 | 12.5 | 2.47 | 4.56 |
交联羧甲基纤维素钠 | - | - | 1 |
交联聚维酮 | - | 1.2 | - |
共聚维酮 | - | - | 4 |
聚乙二醇6000 | - | 0.3 | - |
微粉硅胶 | - | 1 | 0.3 |
硬脂酸镁 | 0.31 | 0.03 | 0.14 |
原辅料名称 | 对比例7 | 对比例8 | 对比例9 |
左乙拉西坦 | 50 | 25 | 50 |
微晶纤维素 | 12.5 | 2.47 | 4.56 |
交联羧甲基纤维素钠 | - | - | 1 |
交联聚维酮 | - | 1.2 | - |
共聚维酮 | - | - | 4 |
聚乙二醇6000 | - | 0.3 | - |
微粉硅胶 | - | 1 | 0.3 |
硬脂酸镁 | 0.31 | 0.03 | 0.14 |
原辅料名称 | 对比例10 | 对比例11 | 对比例12 |
左乙拉西坦 | 50 | 25 | 50 |
微晶纤维素 | 12.5 | 2.47 | 4.56 |
交联羧甲基纤维素钠 | - | - | 1 |
交联聚维酮 | - | 1.2 | - |
共聚维酮 | - | - | 4 |
聚乙二醇6000 | - | 0.3 | - |
微粉硅胶 | - | 1 | 0.3 |
硬脂酸镁 | 0.31 | 0.03 | 0.14 |
Claims (4)
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CN 201210552335 CN102973531B (zh) | 2012-12-18 | 2012-12-18 | 一种左乙拉西坦药物组合物及其制备方法 |
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CN102973531A true CN102973531A (zh) | 2013-03-20 |
CN102973531B CN102973531B (zh) | 2013-10-16 |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105997914A (zh) * | 2016-07-20 | 2016-10-12 | 南通雅本化学有限公司 | 一种左乙拉西坦组合药物及其制备方法 |
CN107721897A (zh) * | 2017-10-19 | 2018-02-23 | 扬子江药业集团南京海陵药业有限公司 | 一种左乙拉西坦新晶型及其制备方法 |
CN112870176A (zh) * | 2021-01-22 | 2021-06-01 | 天地恒一制药股份有限公司 | 一种左乙拉西坦片剂及其制备方法 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101612135A (zh) * | 2009-07-28 | 2009-12-30 | 无锡鼎福药业有限公司 | 一种用于直接压片的左乙拉西坦组合物及其制备方法 |
CN101693017A (zh) * | 2009-10-28 | 2010-04-14 | 北京赛科药业有限责任公司 | 左乙拉西坦的药物组合物及其制备方法 |
CN102038657A (zh) * | 2009-10-10 | 2011-05-04 | 浙江华海药业股份有限公司 | 左乙拉西坦片及其制备方法 |
WO2012159609A1 (de) * | 2011-05-26 | 2012-11-29 | Stada Arzneimittel Ag | Pulverförmige mischung zur herstellung von levetiracetam-haltigen tabletten |
-
2012
- 2012-12-18 CN CN 201210552335 patent/CN102973531B/zh not_active Expired - Fee Related
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101612135A (zh) * | 2009-07-28 | 2009-12-30 | 无锡鼎福药业有限公司 | 一种用于直接压片的左乙拉西坦组合物及其制备方法 |
CN102038657A (zh) * | 2009-10-10 | 2011-05-04 | 浙江华海药业股份有限公司 | 左乙拉西坦片及其制备方法 |
CN101693017A (zh) * | 2009-10-28 | 2010-04-14 | 北京赛科药业有限责任公司 | 左乙拉西坦的药物组合物及其制备方法 |
WO2012159609A1 (de) * | 2011-05-26 | 2012-11-29 | Stada Arzneimittel Ag | Pulverförmige mischung zur herstellung von levetiracetam-haltigen tabletten |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105997914A (zh) * | 2016-07-20 | 2016-10-12 | 南通雅本化学有限公司 | 一种左乙拉西坦组合药物及其制备方法 |
CN107721897A (zh) * | 2017-10-19 | 2018-02-23 | 扬子江药业集团南京海陵药业有限公司 | 一种左乙拉西坦新晶型及其制备方法 |
CN112870176A (zh) * | 2021-01-22 | 2021-06-01 | 天地恒一制药股份有限公司 | 一种左乙拉西坦片剂及其制备方法 |
CN112870176B (zh) * | 2021-01-22 | 2021-11-02 | 天地恒一制药股份有限公司 | 一种左乙拉西坦片剂及其制备方法 |
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Address after: Tianjin City, Nankai District road 300384 yuan Huayuan new technology industrial park, 5 block D No. 9 Patentee after: Nankai Yungong Pharmaceutical Science-Technology Co., Ltd., Tianjin Patentee after: Tongliao Huabang Pharmaceutical Co Ltd Patentee after: Tibet Linzhi Baisheng Pharmaceutical Co., Ltd. Address before: Tianjin City, Nankai District road 300384 yuan Huayuan new technology industrial park, 5 block D No. 9 Patentee before: Nankai Yungong Pharmaceutical Science-Technology Co., Ltd., Tianjin Patentee before: Naikai Share Pharmaceutical Co., Ltd. Patentee before: Tibet Linzhi Baisheng Pharmaceutical Co., Ltd. |
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Effective date of registration: 20190412 Address after: 028100 Tiedong, Ganqika Town, Kezuo Houqi, Tongliao City, Inner Mongolia Autonomous Region Co-patentee after: Tibet Linzhi Baisheng Pharmaceutical Co., Ltd. Patentee after: Tongliao Huabang Pharmaceutical Co Ltd Address before: 300384 9/F, Block D, No. 5 Lanyuan Road, Huayuan New Technology Industrial Park, Nankai District, Tianjin Co-patentee before: Tongliao Huabang Pharmaceutical Co Ltd Patentee before: Nankai Yungong Pharmaceutical Science-Technology Co., Ltd., Tianjin Co-patentee before: Tibet Linzhi Baisheng Pharmaceutical Co., Ltd. |
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Granted publication date: 20131016 Termination date: 20191218 |