CN1321642C - 泮托拉唑钠肠溶微丸 - Google Patents
泮托拉唑钠肠溶微丸 Download PDFInfo
- Publication number
- CN1321642C CN1321642C CNB2003101126070A CN200310112607A CN1321642C CN 1321642 C CN1321642 C CN 1321642C CN B2003101126070 A CNB2003101126070 A CN B2003101126070A CN 200310112607 A CN200310112607 A CN 200310112607A CN 1321642 C CN1321642 C CN 1321642C
- Authority
- CN
- China
- Prior art keywords
- pantoprazole sodium
- enteric
- enteric coated
- pill
- pantoprazole
- 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.)
- Expired - Lifetime
Links
- YNWDKZIIWCEDEE-UHFFFAOYSA-N pantoprazole sodium Chemical compound [Na+].COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC YNWDKZIIWCEDEE-UHFFFAOYSA-N 0.000 title claims abstract description 78
- 229960004048 pantoprazole sodium Drugs 0.000 title claims abstract description 74
- QMBJSIBWORFWQT-DFXBJWIESA-N Chlormadinone acetate Chemical compound C1=C(Cl)C2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(C)=O)(OC(=O)C)[C@@]1(C)CC2 QMBJSIBWORFWQT-DFXBJWIESA-N 0.000 title claims description 28
- 230000001458 anti-acid effect Effects 0.000 claims abstract description 28
- 239000003814 drug Substances 0.000 claims abstract description 16
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 14
- 239000000126 substance Substances 0.000 claims abstract description 5
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 22
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims description 19
- 229930064664 L-arginine Natural products 0.000 claims description 19
- 235000014852 L-arginine Nutrition 0.000 claims description 19
- 238000007789 sealing Methods 0.000 claims description 18
- 239000010410 layer Substances 0.000 claims description 17
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims description 12
- 239000001069 triethyl citrate Substances 0.000 claims description 12
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims description 12
- 235000013769 triethyl citrate Nutrition 0.000 claims description 12
- 239000004408 titanium dioxide Substances 0.000 claims description 11
- 239000000463 material Substances 0.000 claims description 10
- 239000012055 enteric layer Substances 0.000 claims description 9
- 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 8
- -1 magnesium stearate Chemical compound 0.000 claims description 7
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 claims description 6
- 239000002253 acid Substances 0.000 claims description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 6
- 229960005019 pantoprazole Drugs 0.000 claims description 6
- 239000011347 resin Substances 0.000 claims description 5
- 229920005989 resin Polymers 0.000 claims description 5
- 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 claims description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
- 239000002671 adjuvant Substances 0.000 claims description 4
- 239000002994 raw material Substances 0.000 claims description 4
- 239000005720 sucrose Substances 0.000 claims description 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 3
- 239000000314 lubricant Substances 0.000 claims description 3
- 235000019359 magnesium stearate Nutrition 0.000 claims description 3
- HNJBEVLQSNELDL-UHFFFAOYSA-N pyrrolidin-2-one Chemical compound O=C1CCCN1 HNJBEVLQSNELDL-UHFFFAOYSA-N 0.000 claims description 3
- 239000000741 silica gel Substances 0.000 claims description 3
- 229910002027 silica gel Inorganic materials 0.000 claims description 3
- 239000005995 Aluminium silicate Substances 0.000 claims description 2
- 235000012211 aluminium silicate Nutrition 0.000 claims description 2
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 claims description 2
- 239000001913 cellulose Substances 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims 1
- 239000002775 capsule Substances 0.000 abstract description 29
- 238000002360 preparation method Methods 0.000 abstract description 18
- 238000002955 isolation Methods 0.000 abstract description 3
- 206010067484 Adverse reaction Diseases 0.000 abstract 1
- 229920006397 acrylic thermoplastic Polymers 0.000 abstract 1
- 230000006838 adverse reaction Effects 0.000 abstract 1
- 230000009748 deglutition Effects 0.000 abstract 1
- 210000000936 intestine Anatomy 0.000 abstract 1
- 229920003229 poly(methyl methacrylate) Polymers 0.000 abstract 1
- ISXSCDLOGDJUNJ-UHFFFAOYSA-N tert-butyl prop-2-enoate Chemical compound CC(C)(C)OC(=O)C=C ISXSCDLOGDJUNJ-UHFFFAOYSA-N 0.000 abstract 1
- 238000000576 coating method Methods 0.000 description 29
- 239000011248 coating agent Substances 0.000 description 27
- 239000000843 powder Substances 0.000 description 20
- 238000012360 testing method Methods 0.000 description 19
- 235000010603 pastilles Nutrition 0.000 description 14
- 238000000338 in vitro Methods 0.000 description 12
- 239000004615 ingredient Substances 0.000 description 9
- 239000000243 solution Substances 0.000 description 9
- 238000000034 method Methods 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 7
- 239000002702 enteric coating Substances 0.000 description 6
- 238000009505 enteric coating Methods 0.000 description 6
- 230000000968 intestinal effect Effects 0.000 description 6
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 5
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 5
- 238000013112 stability test Methods 0.000 description 5
- 229920003081 Povidone K 30 Polymers 0.000 description 4
- 239000011230 binding agent Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 210000004211 gastric acid Anatomy 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000008188 pellet Substances 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 229920003138 Eudragit® L 30 D-55 Polymers 0.000 description 2
- 229920003134 Eudragit® polymer Polymers 0.000 description 2
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 2
- 208000007107 Stomach Ulcer Diseases 0.000 description 2
- 208000025865 Ulcer Diseases 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- 230000002950 deficient Effects 0.000 description 2
- 238000007599 discharging Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 230000002183 duodenal effect Effects 0.000 description 2
- GDCRSXZBSIRSFR-UHFFFAOYSA-N ethyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.CCOC(=O)C=C GDCRSXZBSIRSFR-UHFFFAOYSA-N 0.000 description 2
- 235000021050 feed intake Nutrition 0.000 description 2
- 201000005917 gastric ulcer Diseases 0.000 description 2
- 230000009931 harmful effect Effects 0.000 description 2
- 229960003943 hypromellose Drugs 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 231100000397 ulcer Toxicity 0.000 description 2
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
- 239000004925 Acrylic resin Substances 0.000 description 1
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 206010009866 Cold sweat Diseases 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 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 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 235000010489 acacia gum Nutrition 0.000 description 1
- 239000001785 acacia senegal l. willd gum Substances 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 229940069428 antacid Drugs 0.000 description 1
- 239000003159 antacid agent Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 239000002532 enzyme inhibitor Substances 0.000 description 1
- 229940125532 enzyme inhibitor Drugs 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 208000021302 gastroesophageal reflux disease Diseases 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 239000011229 interlayer Substances 0.000 description 1
- 229960003174 lansoprazole Drugs 0.000 description 1
- MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 229960000381 omeprazole Drugs 0.000 description 1
- 229940006344 pantoprazole 40 mg Drugs 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 208000000689 peptic esophagitis Diseases 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Claims (6)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2003101126070A CN1321642C (zh) | 2003-12-12 | 2003-12-12 | 泮托拉唑钠肠溶微丸 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2003101126070A CN1321642C (zh) | 2003-12-12 | 2003-12-12 | 泮托拉唑钠肠溶微丸 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1546025A CN1546025A (zh) | 2004-11-17 |
CN1321642C true CN1321642C (zh) | 2007-06-20 |
Family
ID=34336584
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2003101126070A Expired - Lifetime CN1321642C (zh) | 2003-12-12 | 2003-12-12 | 泮托拉唑钠肠溶微丸 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN1321642C (zh) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100423722C (zh) * | 2004-12-10 | 2008-10-08 | 山东绿叶制药有限公司 | 泮托拉唑或其盐的口服肠溶微丸及其制备工艺 |
CN101057837B (zh) * | 2006-04-20 | 2010-12-22 | 湖南九典制药有限公司 | 一种右旋酮洛芬肠溶微丸及制备方法 |
CN101596165B (zh) * | 2008-06-04 | 2012-07-11 | 永信药品工业(昆山)有限公司 | 泮托拉唑钠肠溶微丸 |
CN101836985A (zh) * | 2009-03-17 | 2010-09-22 | 北京利乐生制药科技有限公司 | 一种含有左旋泮托拉唑镁的药物制剂及其制备方法 |
CN102552159B (zh) * | 2010-12-22 | 2013-07-17 | 南京长澳医药科技有限公司 | 雷贝拉唑钠肠溶微丸及其制备方法 |
CN104523648A (zh) * | 2014-12-19 | 2015-04-22 | 福州闽海药业有限公司 | 一种泮托拉唑钠肠溶微丸胶囊及其制备方法 |
CN104825414B (zh) * | 2015-05-07 | 2018-11-16 | 山东新时代药业有限公司 | 一种稳定的s-泮托拉唑钠肠溶片 |
CN110200947A (zh) * | 2019-06-27 | 2019-09-06 | 深圳市泛谷药业股份有限公司 | 一种安非他酮肠溶缓释微丸胶囊及其制备方法 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1025151C (zh) * | 1986-04-30 | 1994-06-29 | 哈斯莱股份公司 | 含酸不稳定化合物的口服药用制剂的制备方法 |
-
2003
- 2003-12-12 CN CNB2003101126070A patent/CN1321642C/zh not_active Expired - Lifetime
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1025151C (zh) * | 1986-04-30 | 1994-06-29 | 哈斯莱股份公司 | 含酸不稳定化合物的口服药用制剂的制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN1546025A (zh) | 2004-11-17 |
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GR01 | Patent grant | ||
ASS | Succession or assignment of patent right |
Owner name: NANJING CHANG AO PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: CHANG'AO PHARMACY TECHNOLOGY CO., LTD., NANJING CITY Effective date: 20081107 |
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Effective date of registration: 20081107 Address after: No. eight hundred, No. 2, Liuhe District, Jiangsu, Nanjing Patentee after: CHANG'AO PHARMACEUTICAL TECHNOLOGY (HOLDINGS) LTD. Address before: Jiangsu province Nanjing city Qinhuai District dajiaochang Road No. 30 Patentee before: NANJING CHANGAO PHARMACEUTICAL SCIENCE & TECHNOLOGY Co.,Ltd. |
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C56 | Change in the name or address of the patentee | ||
CP02 | Change in the address of a patent holder |
Address after: Kexinlu Liuhe District of Nanjing City, Jiangsu Province, No. 63 211500 Patentee after: CHANG'AO PHARMACEUTICAL TECHNOLOGY (HOLDINGS) LTD. Address before: 211500 No. eight hundred, No. 2, Liuhe District, Jiangsu, Nanjing Patentee before: CHANG'AO PHARMACEUTICAL TECHNOLOGY (HOLDINGS) LTD. |
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CP02 | Change in the address of a patent holder |
Address after: No. 63 Kexin Road, Jiangbei New District, Nanjing City, Jiangsu Province, 210000 Patentee after: CHANG'AO PHARMACEUTICAL TECHNOLOGY (HOLDINGS) LTD. Address before: Kexinlu Liuhe District of Nanjing City, Jiangsu Province, No. 63 211500 Patentee before: CHANG'AO PHARMACEUTICAL TECHNOLOGY (HOLDINGS) LTD. |
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CX01 | Expiry of patent term |
Granted publication date: 20070620 |
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CX01 | Expiry of patent term |