CN1616080A - 含有谷光甘肽的法罗培南药物组合物 - Google Patents
含有谷光甘肽的法罗培南药物组合物 Download PDFInfo
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- CN1616080A CN1616080A CN 200410077880 CN200410077880A CN1616080A CN 1616080 A CN1616080 A CN 1616080A CN 200410077880 CN200410077880 CN 200410077880 CN 200410077880 A CN200410077880 A CN 200410077880A CN 1616080 A CN1616080 A CN 1616080A
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- Prior art keywords
- faropenem
- glutathione
- hydrate
- compositions
- sodium
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- RWSXRVCMGQZWBV-WDSKDSINSA-N glutathione Chemical compound OC(=O)[C@@H](N)CCC(=O)N[C@@H](CS)C(=O)NCC(O)=O RWSXRVCMGQZWBV-WDSKDSINSA-N 0.000 title claims abstract description 76
- 229960000379 faropenem Drugs 0.000 title claims abstract description 62
- 229960003180 glutathione Drugs 0.000 title claims abstract description 45
- 108010024636 Glutathione Proteins 0.000 title claims abstract description 31
- HGGAKXAHAYOLDJ-FHZUQPTBSA-N 6alpha-[(R)-1-hydroxyethyl]-2-[(R)-tetrahydrofuran-2-yl]pen-2-em-3-carboxylic acid Chemical compound S([C@@H]1[C@H](C(N1C=1C(O)=O)=O)[C@H](O)C)C=1[C@H]1CCCO1 HGGAKXAHAYOLDJ-FHZUQPTBSA-N 0.000 title claims abstract description 28
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 9
- 239000000203 mixture Substances 0.000 claims abstract description 26
- 150000003839 salts Chemical class 0.000 claims abstract description 17
- MOGICMVNWAUWMK-HIXRZVNASA-L disodium;(5r,6s)-6-[(1r)-1-hydroxyethyl]-7-oxo-3-[(2r)-oxolan-2-yl]-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate;pentahydrate Chemical compound O.O.O.O.O.[Na+].[Na+].S([C@@H]1[C@H](C(N1C=1C([O-])=O)=O)[C@H](O)C)C=1[C@H]1CCCO1.S([C@@H]1[C@H](C(N1C=1C([O-])=O)=O)[C@H](O)C)C=1[C@H]1CCCO1 MOGICMVNWAUWMK-HIXRZVNASA-L 0.000 claims description 34
- 239000008187 granular material Substances 0.000 claims description 28
- 238000002360 preparation method Methods 0.000 claims description 18
- 239000003814 drug Substances 0.000 claims description 17
- 239000000843 powder Substances 0.000 claims description 13
- 239000003826 tablet Substances 0.000 claims description 13
- 239000002775 capsule Substances 0.000 claims description 12
- 239000003795 chemical substances by application Substances 0.000 claims description 11
- 238000002347 injection Methods 0.000 claims description 9
- 239000007924 injection Substances 0.000 claims description 9
- 239000003708 ampul Substances 0.000 claims description 4
- 150000004677 hydrates Chemical class 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 3
- 230000035479 physiological effects, processes and functions Effects 0.000 claims description 2
- 235000003969 glutathione Nutrition 0.000 description 32
- 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 14
- 239000011734 sodium Substances 0.000 description 14
- 229910052708 sodium Inorganic materials 0.000 description 14
- 229920002472 Starch Polymers 0.000 description 13
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 13
- 229940079593 drug Drugs 0.000 description 13
- 239000008107 starch Substances 0.000 description 13
- 235000019698 starch Nutrition 0.000 description 13
- 239000000243 solution Substances 0.000 description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
- 230000001476 alcoholic effect Effects 0.000 description 6
- 238000001035 drying Methods 0.000 description 6
- 238000005516 engineering process Methods 0.000 description 6
- 238000012856 packing Methods 0.000 description 6
- 239000000126 substance Substances 0.000 description 5
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 4
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 4
- 229920001353 Dextrin Polymers 0.000 description 4
- 239000004375 Dextrin Substances 0.000 description 4
- 229920000881 Modified starch Polymers 0.000 description 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 4
- 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 4
- 229930006000 Sucrose Natural products 0.000 description 4
- 239000003963 antioxidant agent Substances 0.000 description 4
- 230000003078 antioxidant effect Effects 0.000 description 4
- 235000006708 antioxidants Nutrition 0.000 description 4
- 230000003115 biocidal effect Effects 0.000 description 4
- 235000019425 dextrin Nutrition 0.000 description 4
- 239000002552 dosage form Substances 0.000 description 4
- 238000011156 evaluation Methods 0.000 description 4
- 238000007689 inspection Methods 0.000 description 4
- 235000019359 magnesium stearate Nutrition 0.000 description 4
- 239000000741 silica gel Substances 0.000 description 4
- 229910002027 silica gel Inorganic materials 0.000 description 4
- 229960002920 sorbitol Drugs 0.000 description 4
- 239000005720 sucrose Substances 0.000 description 4
- 238000005303 weighing Methods 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
- 206010013786 Dry skin Diseases 0.000 description 3
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 206010059866 Drug resistance Diseases 0.000 description 2
- 241000192125 Firmicutes Species 0.000 description 2
- 229930182555 Penicillin Natural products 0.000 description 2
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 2
- 239000003242 anti bacterial agent Substances 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 229940088710 antibiotic agent Drugs 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- HHXMXAQDOUCLDN-RXMQYKEDSA-N penem Chemical compound S1C=CN2C(=O)C[C@H]21 HHXMXAQDOUCLDN-RXMQYKEDSA-N 0.000 description 2
- 229940049954 penicillin Drugs 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 239000007916 tablet composition Substances 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 108020004256 Beta-lactamase Proteins 0.000 description 1
- 229930186147 Cephalosporin Natural products 0.000 description 1
- 241000194033 Enterococcus Species 0.000 description 1
- 241000194032 Enterococcus faecalis Species 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 206010057190 Respiratory tract infections Diseases 0.000 description 1
- 241000191940 Staphylococcus Species 0.000 description 1
- 241000193998 Streptococcus pneumoniae Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 150000001336 alkenes Chemical class 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 150000008064 anhydrides Chemical class 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000003781 beta lactamase inhibitor Substances 0.000 description 1
- -1 beta-lactam compound Chemical class 0.000 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 229940126813 beta-lactamase inhibitor Drugs 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229940124587 cephalosporin Drugs 0.000 description 1
- 150000001780 cephalosporins Chemical class 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 239000000890 drug combination Substances 0.000 description 1
- 229940032049 enterococcus faecalis Drugs 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 238000000892 gravimetry Methods 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 150000002961 penems Chemical class 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000007699 photoisomerization reaction Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 206010040872 skin infection Diseases 0.000 description 1
- ICSAXRANXQSPQP-VUKDEKJYSA-M sodium;(5r,6s)-6-[(1r)-1-hydroxyethyl]-7-oxo-3-[(2r)-oxolan-2-yl]-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate Chemical compound [Na+].S([C@@H]1[C@H](C(N1C=1C([O-])=O)=O)[C@H](O)C)C=1[C@H]1CCCO1 ICSAXRANXQSPQP-VUKDEKJYSA-M 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 229940031000 streptococcus pneumoniae Drugs 0.000 description 1
- 208000019206 urinary tract infection Diseases 0.000 description 1
- 229940126085 β‑Lactamase Inhibitor Drugs 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
Description
片剂处方(mg) | 时间 | 外观性状 | 含量% | 有关物质% | 溶出度% |
法罗培南钠123.5,谷胱甘肽20,预胶化淀粉40,羧甲基淀粉钠30,硬脂酸镁6,5%PVP95%乙醇溶液 | 0天 | 淡黄色 | 101.33 | 0.31 | 92.1 |
3月 | 淡黄色 | 98.47 | 1.62 | 91.5 | |
6月 | 淡黄色 | 98.44 | 2.02 | 91.2 |
胶囊处方(mg) | 时间 | 外观性状 | 含量% | 有关物质% | 溶出度% |
法罗培南钠123.5,谷胱甘肽20,羧甲基淀粉钠60,微粉硅胶6,5%PVP95%乙醇溶液 | 0天 | 淡黄色颗粒 | 102.50 | 0.50 | 92.4 |
3月 | 淡黄色颗粒 | 100.32 | 1.51 | 93.9 | |
6月 | 淡黄色颗粒 | 99.54 | 2.11 | 94.3 |
颗粒剂处方(mg) | 时 | 外观性状 | 干燥失 | 含量 | 有关物 | 溶化 |
间 | 重% | % | 质% | 性% | ||
法罗培南钠247,谷胱甘肽20,D-山梨醇270,蔗糖290,羧甲基淀粉钠150,糊精20,薄荷香精,5%PVP95%乙醇溶液 | 0天 | 淡黄色颗粒 | 5.38 | 101.83 | 0.31 | 92.1 |
3月 | 淡黄色颗粒 | 5.66 | 100.28 | 1.36 | 91.4 | |
6月 | 淡黄色颗粒 | 5.44 | 99.23 | 2.27 | 91.2 |
处方(mg) | 外观性状 | 含量%(以无水物计算) | 有关物质% |
法罗培南钠250,谷胱甘肽5 | 白色或淡黄色结晶粉末 | 92.48 | 0.72 |
法罗培南钠250,谷胱甘肽10 | 白色或淡黄色结晶粉末 | 93.35 | 0.52 |
法罗培南钠250,谷胱甘肽15 | 白色或淡黄色结晶粉末 | 93.38 | 0.51 |
Claims (10)
Priority Applications (1)
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CN 200410077880 CN1236814C (zh) | 2004-09-16 | 2004-09-16 | 含有谷胱甘肽的法罗培南药物组合物 |
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CN 200410077880 CN1236814C (zh) | 2004-09-16 | 2004-09-16 | 含有谷胱甘肽的法罗培南药物组合物 |
Publications (2)
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CN1616080A true CN1616080A (zh) | 2005-05-18 |
CN1236814C CN1236814C (zh) | 2006-01-18 |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101756924B (zh) * | 2008-12-24 | 2011-04-13 | 鲁南制药集团股份有限公司 | 法罗培南的缓释片 |
CN101904822B (zh) * | 2009-06-04 | 2011-11-09 | 鲁南制药集团股份有限公司 | 一种法罗培南钠冻干粉针及其制备方法 |
CN101744782B (zh) * | 2010-01-24 | 2012-03-21 | 鲁南贝特制药有限公司 | 一种含有法罗培南钠的片剂 |
-
2004
- 2004-09-16 CN CN 200410077880 patent/CN1236814C/zh active Active
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101756924B (zh) * | 2008-12-24 | 2011-04-13 | 鲁南制药集团股份有限公司 | 法罗培南的缓释片 |
CN101904822B (zh) * | 2009-06-04 | 2011-11-09 | 鲁南制药集团股份有限公司 | 一种法罗培南钠冻干粉针及其制备方法 |
CN101744782B (zh) * | 2010-01-24 | 2012-03-21 | 鲁南贝特制药有限公司 | 一种含有法罗培南钠的片剂 |
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Publication number | Publication date |
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CN1236814C (zh) | 2006-01-18 |
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Owner name: SHANDONG XINSHIDAI PHARMACEUTICAL INDUSTRY CO., LT Free format text: FORMER OWNER: ZHONGHAI BIO-TECHNOLOGY DEVELOPMENT CO., LTD., SHENYANG CITY Effective date: 20131023 |
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Effective date of registration: 20131023 Address after: 273400 Shandong province Feixian County North Ring Road No. 1 Patentee after: Shandong Xinshidai Pharmaceutical Industry Co., Ltd. Address before: South Street in Dongling District of Shenyang city in Liaoning province 110016 129 Lane 28 Building No. 2 Patentee before: Shengyang Zhonghai Biological Technology Development Co., Ltd. |