CN1692909A - 多司马酯分散片及其制备办法 - Google Patents
多司马酯分散片及其制备办法 Download PDFInfo
- Publication number
- CN1692909A CN1692909A CN 200410027074 CN200410027074A CN1692909A CN 1692909 A CN1692909 A CN 1692909A CN 200410027074 CN200410027074 CN 200410027074 CN 200410027074 A CN200410027074 A CN 200410027074A CN 1692909 A CN1692909 A CN 1692909A
- Authority
- CN
- China
- Prior art keywords
- dosmalfate
- starch
- dispersible tablet
- cellulose
- microcrystalline cellulose
- 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.)
- Granted
Links
- 229950002968 dosmalfate Drugs 0.000 title claims description 68
- RIIQJLBJDMMSSK-RHFFRRHRSA-A tetradecaaluminum;[2-methoxy-5-[7-[(2s,3r,4s,5r,6r)-6-[[(2r,3r,4r,5s,6s)-6-methyl-3,4,5-trisulfonatooxyoxan-2-yl]oxymethyl]-3,4,5-trisulfonatooxyoxan-2-yl]oxy-4-oxo-5-sulfonatooxychromen-2-yl]phenyl] sulfate;pentatriacontahydroxide Chemical compound [OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].[Al+3].C1=C(OS([O-])(=O)=O)C(OC)=CC=C1C(OC1=C2)=CC(=O)C1=C(OS([O-])(=O)=O)C=C2O[C@H]1[C@H](OS([O-])(=O)=O)[C@@H](OS([O-])(=O)=O)[C@H](OS([O-])(=O)=O)[C@@H](CO[C@H]2[C@@H]([C@H](OS([O-])(=O)=O)[C@@H](OS([O-])(=O)=O)[C@H](C)O2)OS([O-])(=O)=O)O1 RIIQJLBJDMMSSK-RHFFRRHRSA-A 0.000 title claims description 66
- 238000000034 method Methods 0.000 title claims description 7
- 239000006185 dispersion Substances 0.000 title 1
- 238000002156 mixing Methods 0.000 claims abstract description 23
- 238000001035 drying Methods 0.000 claims abstract description 21
- 229920002472 Starch Polymers 0.000 claims abstract description 18
- 239000008107 starch Substances 0.000 claims abstract description 18
- 235000019698 starch Nutrition 0.000 claims abstract description 18
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract description 16
- 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 abstract description 15
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 5
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 5
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 5
- 208000025865 Ulcer Diseases 0.000 claims abstract 2
- 210000001035 gastrointestinal tract Anatomy 0.000 claims abstract 2
- 231100000397 ulcer Toxicity 0.000 claims abstract 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 44
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 44
- 239000007919 dispersible tablet Substances 0.000 claims description 34
- 239000000203 mixture Substances 0.000 claims description 33
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 25
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 25
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 25
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 25
- 235000019359 magnesium stearate Nutrition 0.000 claims description 22
- 239000008187 granular material Substances 0.000 claims description 20
- 239000007788 liquid Substances 0.000 claims description 20
- 239000007779 soft material Substances 0.000 claims description 20
- 238000005303 weighing Methods 0.000 claims description 20
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 15
- 229950005770 hyprolose Drugs 0.000 claims description 15
- 239000000741 silica gel Substances 0.000 claims description 15
- 229910002027 silica gel Inorganic materials 0.000 claims description 15
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 14
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 14
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 14
- 239000003795 chemical substances by application Substances 0.000 claims description 13
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 12
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 12
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 12
- 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 claims description 11
- 229940013618 stevioside Drugs 0.000 claims description 11
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 claims description 11
- 235000019202 steviosides Nutrition 0.000 claims description 11
- 229920000881 Modified starch Polymers 0.000 claims description 10
- 238000004132 cross linking Methods 0.000 claims description 10
- -1 hydroxypropyl Chemical group 0.000 claims description 8
- 239000004368 Modified starch Substances 0.000 claims description 6
- 235000010980 cellulose Nutrition 0.000 claims description 6
- 229920002678 cellulose Polymers 0.000 claims description 6
- 239000001913 cellulose Substances 0.000 claims description 6
- 235000019426 modified starch Nutrition 0.000 claims description 6
- 238000002360 preparation method Methods 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 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 5
- 239000002671 adjuvant Substances 0.000 claims description 5
- 239000008101 lactose Substances 0.000 claims description 5
- 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 4
- 229920001353 Dextrin Polymers 0.000 claims description 4
- 239000004375 Dextrin Substances 0.000 claims description 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- 125000003118 aryl group Chemical group 0.000 claims description 4
- 239000011230 binding agent Substances 0.000 claims description 4
- 235000019425 dextrin Nutrition 0.000 claims description 4
- 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 claims description 4
- 239000000945 filler Substances 0.000 claims description 4
- 239000001341 hydroxy propyl starch Substances 0.000 claims description 4
- 235000013828 hydroxypropyl starch Nutrition 0.000 claims description 4
- 239000000314 lubricant Substances 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- 229920000609 methyl cellulose Polymers 0.000 claims description 4
- 239000001923 methylcellulose Substances 0.000 claims description 4
- 235000010981 methylcellulose Nutrition 0.000 claims description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 4
- 235000000346 sugar Nutrition 0.000 claims description 4
- 229920002907 Guar gum Polymers 0.000 claims description 3
- 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 claims description 3
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 3
- 239000003292 glue Substances 0.000 claims description 3
- 239000000665 guar gum Substances 0.000 claims description 3
- 235000010417 guar gum Nutrition 0.000 claims description 3
- 229960002154 guar gum Drugs 0.000 claims description 3
- 239000002002 slurry Substances 0.000 claims description 3
- 239000011734 sodium Substances 0.000 claims description 3
- 229910052708 sodium Inorganic materials 0.000 claims description 3
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- 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 2
- 108010011485 Aspartame Proteins 0.000 claims description 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 2
- 239000001856 Ethyl cellulose Substances 0.000 claims 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 claims description 2
- 239000001828 Gelatine Substances 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims description 2
- 229910021502 aluminium hydroxide Inorganic materials 0.000 claims description 2
- 235000010357 aspartame Nutrition 0.000 claims description 2
- 239000000605 aspartame Substances 0.000 claims description 2
- 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 2
- 229960003438 aspartame Drugs 0.000 claims description 2
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 2
- 239000004327 boric acid Substances 0.000 claims description 2
- 229940084030 carboxymethylcellulose calcium Drugs 0.000 claims description 2
- 239000004568 cement Substances 0.000 claims description 2
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims description 2
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 2
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 2
- 229920001249 ethyl cellulose Polymers 0.000 claims description 2
- 229920000159 gelatin Polymers 0.000 claims description 2
- 235000019322 gelatine Nutrition 0.000 claims description 2
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 2
- 229920000053 polysorbate 80 Polymers 0.000 claims description 2
- 229920006316 polyvinylpyrrolidine Polymers 0.000 claims description 2
- 235000015424 sodium Nutrition 0.000 claims description 2
- 229940032147 starch Drugs 0.000 claims description 2
- 239000006188 syrup Substances 0.000 claims description 2
- 235000020357 syrup Nutrition 0.000 claims description 2
- 239000000080 wetting agent Substances 0.000 claims description 2
- 239000000230 xanthan gum Substances 0.000 claims description 2
- 235000010493 xanthan gum Nutrition 0.000 claims description 2
- 229920001285 xanthan gum Polymers 0.000 claims description 2
- 229940082509 xanthan gum Drugs 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims 1
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 abstract 1
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 abstract 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 abstract 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 18
- 238000004090 dissolution Methods 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 239000002552 dosage form Substances 0.000 description 4
- 230000002496 gastric effect Effects 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 208000008469 Peptic Ulcer Diseases 0.000 description 2
- 238000009825 accumulation Methods 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 239000010419 fine particle Substances 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 208000011906 peptic ulcer disease Diseases 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 210000001156 gastric mucosa Anatomy 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 210000004379 membrane Anatomy 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000007613 slurry method Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
Images
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
品种 | 崩解时限 |
多司马酯分散片 | 35秒 |
多司马酯普通片 | 250秒 |
时间(min) | 2 | 4 | 6 | 8 | 10 | 15 | 20 | 30 | 45 | 60 |
普通片 | 3.35 | 9.96 | 12.21 | 16.89 | 21.09 | 27.77 | 50.68 | 64.01 | 81.58 | 92.18 |
分散片 | 74.54 | 84.45 | 87.69 | 89.40 | 91.32 | 93.07 | 95.29 | 95.41 | 95.40 | 95.48 |
时间(min) | 0 | 2 | 4 | 6 | 8 | 10 | 15 | 20 | 30 | 45 | 60 |
普通片 | 0 | 3.35 | 8.96 | 12.21 | 16.89 | 25.09 | 37.77 | 50.68 | 64.01 | 81.58 | 89.18 |
分散片 | 0 | 74.54 | 84.5 | 87.69 | 89.4 | 91.32 | 93.07 | 95.29 | 95.41 | 95.4 | 95.48 |
Claims (8)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2004100270740A CN100372540C (zh) | 2004-05-08 | 2004-05-08 | 多司马酯分散片及其制备办法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2004100270740A CN100372540C (zh) | 2004-05-08 | 2004-05-08 | 多司马酯分散片及其制备办法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1692909A true CN1692909A (zh) | 2005-11-09 |
CN100372540C CN100372540C (zh) | 2008-03-05 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2004100270740A Expired - Lifetime CN100372540C (zh) | 2004-05-08 | 2004-05-08 | 多司马酯分散片及其制备办法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN100372540C (zh) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102462669A (zh) * | 2010-11-19 | 2012-05-23 | 北大方正集团有限公司 | 曲昔派特分散片及其制备方法 |
CN106137990A (zh) * | 2016-07-29 | 2016-11-23 | 花园药业股份有限公司 | 阿奇霉素分散片及其制备工艺 |
WO2020224452A1 (zh) * | 2019-05-05 | 2020-11-12 | 广州新创忆药物临床研究有限公司 | 一种调节人体体重失衡的化合物、其组合物及其应用 |
WO2021078110A1 (zh) * | 2019-10-25 | 2021-04-29 | 广州新创忆药物临床研究有限公司 | 预防或治疗肠易激综合征的药物组合 |
-
2004
- 2004-05-08 CN CNB2004100270740A patent/CN100372540C/zh not_active Expired - Lifetime
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102462669A (zh) * | 2010-11-19 | 2012-05-23 | 北大方正集团有限公司 | 曲昔派特分散片及其制备方法 |
CN102462669B (zh) * | 2010-11-19 | 2013-12-04 | 北大方正集团有限公司 | 曲昔派特分散片及其制备方法 |
CN106137990A (zh) * | 2016-07-29 | 2016-11-23 | 花园药业股份有限公司 | 阿奇霉素分散片及其制备工艺 |
WO2020224452A1 (zh) * | 2019-05-05 | 2020-11-12 | 广州新创忆药物临床研究有限公司 | 一种调节人体体重失衡的化合物、其组合物及其应用 |
WO2021078110A1 (zh) * | 2019-10-25 | 2021-04-29 | 广州新创忆药物临床研究有限公司 | 预防或治疗肠易激综合征的药物组合 |
Also Published As
Publication number | Publication date |
---|---|
CN100372540C (zh) | 2008-03-05 |
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Effective date of registration: 20100910 Address after: 410300, Liuyang City, Hunan province Dong Yang Township (Biological Medicine Park) Patentee after: XIANGBEI WELMAN PHARMACEUTICAL Co.,Ltd. Address before: The city on 510075 Guangzhou Road, Guangdong province science and technology innovation base No. 80 B district two floor Co-patentee before: GUANGZHOU WELMAN NEW DRUG R&D Co.,Ltd. Patentee before: Sun Mingjie Co-patentee before: Wang Ting |
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Address after: 410300, Liuyang City, Hunan province Dong Yang Township (Biological Medicine Park) Patentee after: XIANGBEI WELMAN PHARMACEUTICAL Co.,Ltd. Address before: 410300, Liuyang City, Hunan province Dong Yang Township (Biological Medicine Park) Patentee before: XIANGBEI WELMAN PHARMACEUTICAL Co.,Ltd. |
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CX01 | Expiry of patent term |
Granted publication date: 20080305 |
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CX01 | Expiry of patent term |