CN103145880B - 一种去除依诺肝素钠原料中游离态硫的方法 - Google Patents
一种去除依诺肝素钠原料中游离态硫的方法 Download PDFInfo
- Publication number
- CN103145880B CN103145880B CN201310086760.4A CN201310086760A CN103145880B CN 103145880 B CN103145880 B CN 103145880B CN 201310086760 A CN201310086760 A CN 201310086760A CN 103145880 B CN103145880 B CN 103145880B
- Authority
- CN
- China
- Prior art keywords
- ultrafiltration
- enoxaparin sodium
- molecular weight
- sulphur
- raw material
- 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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- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 title claims abstract description 51
- 239000005864 Sulphur Substances 0.000 title claims abstract description 51
- 229960005153 enoxaparin sodium Drugs 0.000 title claims abstract description 35
- CIJQTPFWFXOSEO-NDMITSJXSA-J tetrasodium;(2r,3r,4s)-2-[(2r,3s,4r,5r,6s)-5-acetamido-6-[(1r,2r,3r,4r)-4-[(2r,3s,4r,5r,6r)-5-acetamido-6-[(4r,5r,6r)-2-carboxylato-4,5-dihydroxy-6-[[(1r,3r,4r,5r)-3-hydroxy-4-(sulfonatoamino)-6,8-dioxabicyclo[3.2.1]octan-2-yl]oxy]oxan-3-yl]oxy-2-(hydroxy Chemical compound [Na+].[Na+].[Na+].[Na+].O([C@@H]1[C@@H](COS(O)(=O)=O)O[C@@H]([C@@H]([C@H]1O)NC(C)=O)O[C@@H]1C(C[C@H]([C@@H]([C@H]1O)O)O[C@@H]1[C@@H](CO)O[C@H](OC2C(O[C@@H](OC3[C@@H]([C@@H](NS([O-])(=O)=O)[C@@H]4OC[C@H]3O4)O)[C@H](O)[C@H]2O)C([O-])=O)[C@H](NC(C)=O)[C@H]1C)C([O-])=O)[C@@H]1OC(C([O-])=O)=C[C@H](O)[C@H]1O CIJQTPFWFXOSEO-NDMITSJXSA-J 0.000 title claims abstract description 35
- 238000000034 method Methods 0.000 title claims abstract description 27
- 239000002994 raw material Substances 0.000 title claims abstract description 27
- 238000000108 ultra-filtration Methods 0.000 claims abstract description 45
- 239000007788 liquid Substances 0.000 claims description 47
- 239000012466 permeate Substances 0.000 claims description 12
- 239000008213 purified water Substances 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 238000001514 detection method Methods 0.000 claims description 8
- 239000012535 impurity Substances 0.000 claims description 7
- 239000004695 Polyether sulfone Substances 0.000 claims description 6
- 238000002347 injection Methods 0.000 claims description 6
- 239000007924 injection Substances 0.000 claims description 6
- 229920006393 polyether sulfone Polymers 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 5
- 239000012528 membrane Substances 0.000 claims description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 4
- DPDMMXDBJGCCQC-UHFFFAOYSA-N [Na].[Cl] Chemical compound [Na].[Cl] DPDMMXDBJGCCQC-UHFFFAOYSA-N 0.000 claims description 4
- 238000004090 dissolution Methods 0.000 claims description 4
- 239000012530 fluid Substances 0.000 claims description 4
- 239000002244 precipitate Substances 0.000 claims description 4
- 239000003814 drug Substances 0.000 abstract description 5
- 229940079593 drug Drugs 0.000 abstract description 4
- 238000009776 industrial production Methods 0.000 abstract 1
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical class OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 10
- 229920000669 heparin Polymers 0.000 description 9
- 239000003055 low molecular weight heparin Substances 0.000 description 9
- 238000003756 stirring Methods 0.000 description 9
- 229940127215 low-molecular weight heparin Drugs 0.000 description 6
- 229960002897 heparin Drugs 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 239000007858 starting material Substances 0.000 description 4
- 208000007536 Thrombosis Diseases 0.000 description 3
- 230000002785 anti-thrombosis Effects 0.000 description 3
- 230000010100 anticoagulation Effects 0.000 description 3
- 102000004190 Enzymes Human genes 0.000 description 2
- 108090000790 Enzymes Proteins 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 2
- 239000003146 anticoagulant agent Substances 0.000 description 2
- 229940127219 anticoagulant drug Drugs 0.000 description 2
- 238000003776 cleavage reaction Methods 0.000 description 2
- 230000002596 correlated effect Effects 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 230000007017 scission Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 229910021653 sulphate ion Inorganic materials 0.000 description 2
- 201000001320 Atherosclerosis Diseases 0.000 description 1
- 101100298225 Caenorhabditis elegans pot-2 gene Proteins 0.000 description 1
- 206010062713 Haemorrhagic diathesis Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 238000002144 chemical decomposition reaction Methods 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 229940121657 clinical drug Drugs 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 210000003298 dental enamel Anatomy 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 208000031169 hemorrhagic disease Diseases 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 150000003384 small molecules Chemical class 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
Abstract
Description
Claims (7)
Priority Applications (1)
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CN201310086760.4A CN103145880B (zh) | 2013-03-19 | 2013-03-19 | 一种去除依诺肝素钠原料中游离态硫的方法 |
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CN201310086760.4A CN103145880B (zh) | 2013-03-19 | 2013-03-19 | 一种去除依诺肝素钠原料中游离态硫的方法 |
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CN103145880A CN103145880A (zh) | 2013-06-12 |
CN103145880B true CN103145880B (zh) | 2015-04-22 |
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CN107041870A (zh) * | 2017-04-06 | 2017-08-15 | 泰山医学院 | 一种预防运动创伤手术后静脉血栓的注射液及其制备方法 |
CN107778382A (zh) * | 2017-11-21 | 2018-03-09 | 河北常山生化药业股份有限公司 | 一种可有效降低依诺肝素钠中乙醇残留的方法 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1315458A (zh) * | 2000-03-31 | 2001-10-03 | 上海惠海生化制品厂 | 低分子肝素及其制备方法 |
CN1421464A (zh) * | 2002-11-29 | 2003-06-04 | 上海惠海生化制品厂 | 低分子肝素钠(钙)及其制备方法 |
CN102040671A (zh) * | 2009-10-13 | 2011-05-04 | 北京贯虹科技有限公司 | 一种超低分子量肝素的制备及纯化工艺 |
-
2013
- 2013-03-19 CN CN201310086760.4A patent/CN103145880B/zh active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1315458A (zh) * | 2000-03-31 | 2001-10-03 | 上海惠海生化制品厂 | 低分子肝素及其制备方法 |
CN1421464A (zh) * | 2002-11-29 | 2003-06-04 | 上海惠海生化制品厂 | 低分子肝素钠(钙)及其制备方法 |
CN102040671A (zh) * | 2009-10-13 | 2011-05-04 | 北京贯虹科技有限公司 | 一种超低分子量肝素的制备及纯化工艺 |
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C53 | Correction of patent of invention or patent application | ||
CB03 | Change of inventor or designer information |
Inventor after: Zhou Xia Inventor after: Guo Enzhong Inventor after: Guo Wei Inventor after: Qiao Deqiang Inventor after: Lin Yong Inventor before: Zhou Xia Inventor before: Guo Enzhong |
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COR | Change of bibliographic data |
Free format text: CORRECT: INVENTOR; FROM: ZHOU XIA GUO ENZHONG TO: ZHOU XIA GUO ENZHONG GUO WEI QIAO DEQIANG LIN YONG |
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TR01 | Transfer of patent right | ||
TR01 | Transfer of patent right |
Effective date of registration: 20190507 Address after: 272350 Zhanghuang Industrial Park, Yutai County, Jining City, Shandong Province Patentee after: SHANDONG CHENLONG PHARMACEUTICAL Co.,Ltd. Address before: 272350 Zhanghuang Town Industrial Park, Yutai County, Jining City, Shandong Province Patentee before: SHANDONG CHENZHONG BIOPHARMACEUTICAL Co.,Ltd. |
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PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A method for removing free sulfur from enoxaparin sodium raw material Effective date of registration: 20220630 Granted publication date: 20150422 Pledgee: Industrial and Commercial Bank of China Limited Jining urban sub branch Pledgor: SHANDONG CHENLONG PHARMACEUTICAL Co.,Ltd. Registration number: Y2022980009589 |
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