CN101797236B - 重酒石酸卡巴拉汀口腔崩解片及其制备方法 - Google Patents
重酒石酸卡巴拉汀口腔崩解片及其制备方法 Download PDFInfo
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- CN101797236B CN101797236B CN2010101307574A CN201010130757A CN101797236B CN 101797236 B CN101797236 B CN 101797236B CN 2010101307574 A CN2010101307574 A CN 2010101307574A CN 201010130757 A CN201010130757 A CN 201010130757A CN 101797236 B CN101797236 B CN 101797236B
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- Prior art keywords
- rivastigmine
- disintegration tablet
- disintegrating agent
- hydrogentartrate
- lubricant
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- XSVMFMHYUFZWBK-NSHDSACASA-N Rivastigmine Chemical compound CCN(C)C(=O)OC1=CC=CC([C@H](C)N(C)C)=C1 XSVMFMHYUFZWBK-NSHDSACASA-N 0.000 title claims abstract description 40
- 229960004136 rivastigmine Drugs 0.000 title claims abstract description 38
- 238000002360 preparation method Methods 0.000 title abstract description 12
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 36
- 238000000034 method Methods 0.000 claims abstract description 31
- 239000000945 filler Substances 0.000 claims abstract description 23
- 239000000314 lubricant Substances 0.000 claims abstract description 23
- 210000000214 mouth Anatomy 0.000 claims abstract description 21
- 239000000843 powder Substances 0.000 claims abstract description 14
- 239000008187 granular material Substances 0.000 claims description 65
- 229950010673 rivastigmine hydrogen tartrate Drugs 0.000 claims description 43
- GWHQHAUAXRMMOT-MBANBULQSA-N rivastigmine tartrate Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O.CCN(C)C(=O)OC1=CC=CC([C@H](C)N(C)C)=C1 GWHQHAUAXRMMOT-MBANBULQSA-N 0.000 claims description 43
- 239000000203 mixture Substances 0.000 claims description 27
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 24
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 22
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 18
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 17
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 17
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- 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 13
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 13
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- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 13
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 12
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- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 10
- 206010013786 Dry skin Diseases 0.000 claims description 10
- 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 10
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- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 7
- 235000010357 aspartame Nutrition 0.000 claims description 7
- 229960003438 aspartame Drugs 0.000 claims description 7
- 238000009702 powder compression Methods 0.000 claims description 7
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 6
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- 235000002906 tartaric acid Nutrition 0.000 claims description 6
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 5
- 238000005469 granulation Methods 0.000 claims description 5
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 16
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- 229960001375 lactose Drugs 0.000 description 9
- 239000011230 binding agent Substances 0.000 description 6
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- 239000003814 drug Substances 0.000 description 5
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 4
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 3
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
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- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 3
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- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
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- 239000004386 Erythritol Substances 0.000 description 2
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 description 2
- 239000001856 Ethyl cellulose Substances 0.000 description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 2
- 229920000881 Modified starch Polymers 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 description 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
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- 238000004519 manufacturing process Methods 0.000 description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 2
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- 229910000029 sodium carbonate Inorganic materials 0.000 description 2
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- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 2
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 2
- 229960002675 xylitol Drugs 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
- 229940100578 Acetylcholinesterase inhibitor Drugs 0.000 description 1
- 229940122041 Cholinesterase inhibitor Drugs 0.000 description 1
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- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
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- 239000000273 veterinary drug Substances 0.000 description 1
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Abstract
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CN2010101307574A CN101797236B (zh) | 2010-03-23 | 2010-03-23 | 重酒石酸卡巴拉汀口腔崩解片及其制备方法 |
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CN2010101307574A CN101797236B (zh) | 2010-03-23 | 2010-03-23 | 重酒石酸卡巴拉汀口腔崩解片及其制备方法 |
Publications (2)
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CN101797236A CN101797236A (zh) | 2010-08-11 |
CN101797236B true CN101797236B (zh) | 2012-05-23 |
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CN2010101307574A Active CN101797236B (zh) | 2010-03-23 | 2010-03-23 | 重酒石酸卡巴拉汀口腔崩解片及其制备方法 |
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Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101836974A (zh) * | 2010-05-27 | 2010-09-22 | 北京德众万全药物技术开发有限公司 | 一种含有重酒石酸卡巴拉汀的药物组合物及其制备方法 |
CN103877045A (zh) * | 2014-03-24 | 2014-06-25 | 张绪伟 | 一种重酒石酸卡巴拉汀崩解片及其制备方法 |
CN112641741A (zh) * | 2020-12-29 | 2021-04-13 | 卓和药业集团有限公司 | 一种含有重酒石酸卡巴拉汀的口崩片及其制备方法 |
Family Cites Families (4)
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DE69923200T2 (de) * | 1998-10-01 | 2005-12-22 | Novartis Ag | Neue oral anzuwendende arzneizubereitungen für rivastigmine mit kontrollierter wirkstoffabgabe |
GB9923045D0 (en) * | 1999-09-29 | 1999-12-01 | Novartis Ag | New oral formulations |
CN101204389A (zh) * | 2006-12-19 | 2008-06-25 | 北京德众万全药物技术开发有限公司 | 一种含有重酒石酸卡巴拉汀的药物组合物及其制备方法 |
JP2011506279A (ja) * | 2007-12-08 | 2011-03-03 | バイエル・シェーリング・ファルマ・アクチェンゲゼルシャフト | 経口で分散可能な錠剤 |
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Address after: 400715 No. 2, Tiansheng Road, Beibei District, Chongqing Patentee after: Southwest University Address before: 402460 No. 160 Changyuan Street College Road, Rongchang District, Chongqing Patentee before: Southwest University |
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Effective date of registration: 20220906 Address after: Room 709-11, Floor C1, CMC Building, No. 1, Yaocheng Avenue, Pharmaceutical High-tech Industrial Development Zone, Taizhou City, Jiangsu Province (south of Yaocheng Avenue and east of Koutai Road), 225300 Patentee after: Taizhou jundao Litong Biotechnology Co.,Ltd. Address before: Room 101, floor 1-5, building 351, Shuian manor, Chaoyang District, Beijing 100012 (01) 101057 Patentee before: Beijing zhongronglong Trading Co.,Ltd. |