CN104523746A - 一种埃索美拉唑镁碳酸氢钠组合物 - Google Patents
一种埃索美拉唑镁碳酸氢钠组合物 Download PDFInfo
- Publication number
- CN104523746A CN104523746A CN201510051236.2A CN201510051236A CN104523746A CN 104523746 A CN104523746 A CN 104523746A CN 201510051236 A CN201510051236 A CN 201510051236A CN 104523746 A CN104523746 A CN 104523746A
- Authority
- CN
- China
- Prior art keywords
- esomeprazole magnesium
- pharmaceutical composition
- sodium bicarbonate
- magnesium
- composition containing
- 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
- 239000000203 mixture Substances 0.000 title claims abstract description 60
- SUBDBMMJDZJVOS-DEOSSOPVSA-N esomeprazole Chemical compound C([S@](=O)C1=NC2=CC=C(C=C2N1)OC)C1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-DEOSSOPVSA-N 0.000 title abstract description 10
- 229960004770 esomeprazole Drugs 0.000 title abstract description 9
- OBGLKIIPIZLFRH-UHFFFAOYSA-K magnesium sodium hydrogen carbonate Chemical compound [Na+].[Mg+2].OC([O-])=O.OC([O-])=O.OC([O-])=O OBGLKIIPIZLFRH-UHFFFAOYSA-K 0.000 title abstract 4
- 229960000197 esomeprazole magnesium Drugs 0.000 claims abstract description 76
- KWORUUGOSLYAGD-WLHYKHABSA-N magnesium;5-methoxy-2-[(r)-(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide Chemical compound [Mg+2].C([S@@](=O)C=1[N-]C2=CC=C(C=C2N=1)OC)C1=NC=C(C)C(OC)=C1C.C([S@@](=O)C=1[N-]C2=CC=C(C=C2N=1)OC)C1=NC=C(C)C(OC)=C1C KWORUUGOSLYAGD-WLHYKHABSA-N 0.000 claims abstract description 76
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims abstract description 40
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 27
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims abstract description 21
- 235000017557 sodium bicarbonate Nutrition 0.000 claims abstract description 21
- 239000008187 granular material Substances 0.000 claims description 32
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims description 28
- 229940049654 glyceryl behenate Drugs 0.000 claims description 28
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 27
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 27
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 27
- 239000011230 binding agent Substances 0.000 claims description 24
- 238000002360 preparation method Methods 0.000 claims description 22
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 20
- 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 14
- 229920002472 Starch Polymers 0.000 claims description 14
- 239000011734 sodium Substances 0.000 claims description 14
- 229910052708 sodium Inorganic materials 0.000 claims description 14
- 239000008107 starch Substances 0.000 claims description 14
- 235000019698 starch Nutrition 0.000 claims description 14
- 238000002156 mixing Methods 0.000 claims description 13
- 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 12
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 11
- 239000000741 silica gel Substances 0.000 claims description 11
- 229910002027 silica gel Inorganic materials 0.000 claims description 11
- 235000019359 magnesium stearate Nutrition 0.000 claims description 10
- 239000003795 chemical substances by application Substances 0.000 claims description 9
- 239000000314 lubricant Substances 0.000 claims description 9
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 8
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 7
- 239000002775 capsule Substances 0.000 claims description 7
- 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 6
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 6
- 238000004132 cross linking Methods 0.000 claims description 6
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 6
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 6
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 6
- 238000004519 manufacturing process Methods 0.000 abstract description 5
- 229940079593 drug Drugs 0.000 abstract description 4
- 238000009776 industrial production Methods 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 13
- 238000012360 testing method Methods 0.000 description 10
- 238000000034 method Methods 0.000 description 8
- 239000000243 solution Substances 0.000 description 8
- 208000021302 gastroesophageal reflux disease Diseases 0.000 description 7
- 239000000047 product Substances 0.000 description 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 238000004811 liquid chromatography Methods 0.000 description 4
- 239000008363 phosphate buffer Substances 0.000 description 4
- 239000002253 acid Substances 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 239000000945 filler Substances 0.000 description 3
- 239000000706 filtrate Substances 0.000 description 3
- 230000027119 gastric acid secretion Effects 0.000 description 3
- 239000013558 reference substance Substances 0.000 description 3
- 241000590002 Helicobacter pylori Species 0.000 description 2
- IXEQEYRTSRFZEO-UHFFFAOYSA-N Omeprazole sulfone Chemical compound N1C2=CC(OC)=CC=C2N=C1S(=O)(=O)CC1=NC=C(C)C(OC)=C1C IXEQEYRTSRFZEO-UHFFFAOYSA-N 0.000 description 2
- 102100021904 Potassium-transporting ATPase alpha chain 1 Human genes 0.000 description 2
- 108010083204 Proton Pumps Proteins 0.000 description 2
- WEVYAHXRMPXWCK-UHFFFAOYSA-N acetonitrile Substances CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 2
- 229910000397 disodium phosphate Inorganic materials 0.000 description 2
- 235000019800 disodium phosphate Nutrition 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229940037467 helicobacter pylori Drugs 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- FPLYNRPOIZEADP-UHFFFAOYSA-N octylsilane Chemical group CCCCCCCC[SiH3] FPLYNRPOIZEADP-UHFFFAOYSA-N 0.000 description 2
- 210000001711 oxyntic cell Anatomy 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000001488 sodium phosphate Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- HLLSOEKIMZEGFV-UHFFFAOYSA-N 4-(dibutylsulfamoyl)benzoic acid Chemical compound CCCCN(CCCC)S(=O)(=O)C1=CC=C(C(O)=O)C=C1 HLLSOEKIMZEGFV-UHFFFAOYSA-N 0.000 description 1
- 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
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 241000589989 Helicobacter Species 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 102000029749 Microtubule Human genes 0.000 description 1
- 108091022875 Microtubule Proteins 0.000 description 1
- 240000000249 Morus alba Species 0.000 description 1
- 235000008708 Morus alba Nutrition 0.000 description 1
- 206010030216 Oesophagitis Diseases 0.000 description 1
- 208000008469 Peptic Ulcer Diseases 0.000 description 1
- 244000061458 Solanum melongena Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 238000011203 antimicrobial therapy Methods 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000000890 drug combination Substances 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 229960000496 esomeprazole sodium Drugs 0.000 description 1
- 208000006881 esophagitis Diseases 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- MQEUGMWHWPYFDD-JIDHJSLPSA-N magnesium;6-methoxy-2-[(s)-(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole Chemical compound [Mg].C([S@](=O)C1=NC2=CC=C(C=C2N1)OC)C1=NC=C(C)C(OC)=C1C MQEUGMWHWPYFDD-JIDHJSLPSA-N 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 125000006216 methylsulfinyl group Chemical group [H]C([H])([H])S(*)=O 0.000 description 1
- 210000004688 microtubule Anatomy 0.000 description 1
- 229960000381 omeprazole Drugs 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 208000000689 peptic esophagitis Diseases 0.000 description 1
- 208000011906 peptic ulcer disease Diseases 0.000 description 1
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 description 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
- 210000001187 pylorus Anatomy 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000008685 targeting Effects 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510051236.2A CN104523746B (zh) | 2015-02-02 | 2015-02-02 | 一种埃索美拉唑镁碳酸氢钠组合物 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510051236.2A CN104523746B (zh) | 2015-02-02 | 2015-02-02 | 一种埃索美拉唑镁碳酸氢钠组合物 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN104523746A true CN104523746A (zh) | 2015-04-22 |
CN104523746B CN104523746B (zh) | 2017-07-07 |
Family
ID=52839503
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201510051236.2A Active CN104523746B (zh) | 2015-02-02 | 2015-02-02 | 一种埃索美拉唑镁碳酸氢钠组合物 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN104523746B (zh) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN109200020A (zh) * | 2017-07-07 | 2019-01-15 | 长春海悦药业股份有限公司 | 一种埃索美拉唑镁的药物组合物 |
CN112494451A (zh) * | 2020-03-24 | 2021-03-16 | 长春海悦药业股份有限公司 | 一种埃索美拉唑镁碳酸氢钠胶囊 |
US11759428B2 (en) | 2018-01-29 | 2023-09-19 | Chong Kun Dang Pharmaceutical Corp. | Pharmaceutical formulation comprising esomeprazole and sodium bicarbonate |
US11813285B2 (en) | 2018-01-29 | 2023-11-14 | Chong Kun Dang Pharmaceutical Corp. | Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102078616A (zh) * | 2011-01-28 | 2011-06-01 | 北京虹湾医药技术有限公司 | 埃索美拉唑碳酸氢钠组合物 |
CN102397277A (zh) * | 2011-11-17 | 2012-04-04 | 成都欣捷高新技术开发有限公司 | 包含埃索美拉唑的药物组合物 |
CN103845734A (zh) * | 2014-03-20 | 2014-06-11 | 辽宁亿灵科创生物医药科技有限公司 | 埃索美拉唑药物组合物及其制剂 |
-
2015
- 2015-02-02 CN CN201510051236.2A patent/CN104523746B/zh active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102078616A (zh) * | 2011-01-28 | 2011-06-01 | 北京虹湾医药技术有限公司 | 埃索美拉唑碳酸氢钠组合物 |
CN102397277A (zh) * | 2011-11-17 | 2012-04-04 | 成都欣捷高新技术开发有限公司 | 包含埃索美拉唑的药物组合物 |
CN103845734A (zh) * | 2014-03-20 | 2014-06-11 | 辽宁亿灵科创生物医药科技有限公司 | 埃索美拉唑药物组合物及其制剂 |
Non-Patent Citations (2)
Title |
---|
杨怡静等: ""山嵛酸甘油酯作为片剂润滑剂的研究"", 《中国现代应用药学》 * |
罗明生等: "《中国药用辅料》", 30 April 2006, 化学工业出版社 * |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN109200020A (zh) * | 2017-07-07 | 2019-01-15 | 长春海悦药业股份有限公司 | 一种埃索美拉唑镁的药物组合物 |
US11759428B2 (en) | 2018-01-29 | 2023-09-19 | Chong Kun Dang Pharmaceutical Corp. | Pharmaceutical formulation comprising esomeprazole and sodium bicarbonate |
US11813285B2 (en) | 2018-01-29 | 2023-11-14 | Chong Kun Dang Pharmaceutical Corp. | Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate |
CN112494451A (zh) * | 2020-03-24 | 2021-03-16 | 长春海悦药业股份有限公司 | 一种埃索美拉唑镁碳酸氢钠胶囊 |
Also Published As
Publication number | Publication date |
---|---|
CN104523746B (zh) | 2017-07-07 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN103655570B (zh) | 西格列汀与二甲双胍复方缓释制剂及其制备方法 | |
CN104523746A (zh) | 一种埃索美拉唑镁碳酸氢钠组合物 | |
CN103463130B (zh) | 一种复方氨酚烷胺胶囊的制备方法 | |
Sokar et al. | Pulsatile core-in-cup valsartan tablet formulations: in vitro evaluation | |
Wilson et al. | Sustained release enteric coated tablets of pantoprazole: Formulation, in vitro and in vivo evaluation | |
CN103181923B (zh) | 包含瑞格列奈的药物制剂及其制备方法 | |
JP6942263B2 (ja) | コロイドビスマスペクチン又はコロイドビスマスペクチン含有製剤中の遊離ビスマスの測定方法 | |
Rathore et al. | Formulation and evaluation of enteric coated tablet of Ilaprazole | |
CN107412198A (zh) | 盐酸度洛西汀肠溶缓释颗粒剂及其制备方法 | |
CN105456213A (zh) | 一种孟鲁司特钠片剂 | |
CN112386578B (zh) | 一种孟鲁司特钠咀嚼片及其制备方法 | |
Kadam et al. | Formulation and evaluation of colon targeted enteric coated tablets of loperamide | |
CN106902097B (zh) | 一种可改善药物生物利用度的药物组合物 | |
CN109200020A (zh) | 一种埃索美拉唑镁的药物组合物 | |
CN103385863B (zh) | 一种薁磺酸钠缓释制剂 | |
Giri et al. | Formulation and evaluation of glipizide sustain release matrix tablets | |
CN103230380B (zh) | 双丙戊酸钠肠溶片芯及其制备方法和其应用 | |
CN103655607B (zh) | 一种含有奥美拉唑的药物组合物 | |
CN107224585B (zh) | 一种包含非甾体抗炎药和质子泵抑制剂的组合物 | |
CN103800326B (zh) | 一种泮托拉唑钠药物组合物、含有该组合物的微丸及其制备方法 | |
CN106913543B (zh) | 一种达比加群酯片剂及其制备方法 | |
CN104644601B (zh) | 一种卡培他滨片剂 | |
CN103989645A (zh) | 一种孟鲁司特钠片剂及其制备方法 | |
CN112494459B (zh) | 一种药物制剂及其用途 | |
AU2021107494A4 (en) | Novel dissolution testing procedure for PANTOPRAZOLE (EC) pellets |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
CB02 | Change of applicant information |
Address after: 130012, 672, pioneering street, hi tech Zone, Jilin, Changchun Applicant after: CHANGCHUN HAIYUE PHARMACEUTICAL Co.,Ltd. Address before: 130012, 672, pioneering street, hi tech Zone, Jilin, Changchun Applicant before: Changchun Haiyue Pharmaceutical Co.,Ltd. |
|
COR | Change of bibliographic data | ||
GR01 | Patent grant | ||
GR01 | Patent grant | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A combination of esomeprazole magnesium bicarbonate and sodium bicarbonate Effective date of registration: 20231226 Granted publication date: 20170707 Pledgee: China Construction Bank Co.,Ltd. Changchun Science and Technology Sub branch Pledgor: CHANGCHUN HAIYUE PHARMACEUTICAL Co.,Ltd. Registration number: Y2023220000149 |