CN103462909B - 一种注射用尼扎替丁制剂 - Google Patents
一种注射用尼扎替丁制剂 Download PDFInfo
- Publication number
- CN103462909B CN103462909B CN201310413033.4A CN201310413033A CN103462909B CN 103462909 B CN103462909 B CN 103462909B CN 201310413033 A CN201310413033 A CN 201310413033A CN 103462909 B CN103462909 B CN 103462909B
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- Prior art keywords
- nizatidine
- injection
- mannitol
- speed
- filter element
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- 229960004872 nizatidine Drugs 0.000 title claims abstract description 36
- SGXXNSQHWDMGGP-IZZDOVSWSA-N nizatidine Chemical compound [O-][N+](=O)\C=C(/NC)NCCSCC1=CSC(CN(C)C)=N1 SGXXNSQHWDMGGP-IZZDOVSWSA-N 0.000 title claims abstract description 35
- 238000002347 injection Methods 0.000 title claims abstract description 22
- 239000007924 injection Substances 0.000 title claims abstract description 22
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 238000005516 engineering process Methods 0.000 title description 2
- 239000000203 mixture Substances 0.000 title description 2
- 238000009472 formulation Methods 0.000 title 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 16
- 229930195725 Mannitol Natural products 0.000 claims abstract description 16
- 239000000594 mannitol Substances 0.000 claims abstract description 16
- 235000010355 mannitol Nutrition 0.000 claims abstract description 16
- 238000003756 stirring Methods 0.000 claims description 8
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 7
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 6
- 239000012752 auxiliary agent Substances 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 6
- 239000000047 product Substances 0.000 claims description 6
- 238000000859 sublimation Methods 0.000 claims description 6
- 230000008022 sublimation Effects 0.000 claims description 6
- 238000010792 warming Methods 0.000 claims description 6
- 238000001914 filtration Methods 0.000 claims description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- 239000004695 Polyether sulfone Substances 0.000 claims description 4
- 229910052799 carbon Inorganic materials 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 claims description 4
- 229920006393 polyether sulfone Polymers 0.000 claims description 4
- -1 polypropylene Polymers 0.000 claims description 4
- 239000000243 solution Substances 0.000 claims description 4
- 239000008215 water for injection Substances 0.000 claims description 4
- 239000004743 Polypropylene Substances 0.000 claims description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 2
- 229910052782 aluminium Inorganic materials 0.000 claims description 2
- 239000004411 aluminium Substances 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 claims description 2
- 239000002158 endotoxin Substances 0.000 claims description 2
- 238000011049 filling Methods 0.000 claims description 2
- 239000012467 final product Substances 0.000 claims description 2
- 238000004108 freeze drying Methods 0.000 claims description 2
- 238000007689 inspection Methods 0.000 claims description 2
- 238000002372 labelling Methods 0.000 claims description 2
- 239000000463 material Substances 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 230000003020 moisturizing effect Effects 0.000 claims description 2
- 229920001155 polypropylene Polymers 0.000 claims description 2
- 239000002994 raw material Substances 0.000 claims description 2
- 238000005096 rolling process Methods 0.000 claims description 2
- 238000005092 sublimation method Methods 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 7
- 239000000843 powder Substances 0.000 abstract description 7
- 229940079593 drug Drugs 0.000 abstract description 3
- 239000012535 impurity Substances 0.000 description 3
- 229920002307 Dextran Polymers 0.000 description 2
- NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 description 2
- 206010030216 Oesophagitis Diseases 0.000 description 2
- 208000007107 Stomach Ulcer Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 208000000718 duodenal ulcer Diseases 0.000 description 2
- 201000006549 dyspepsia Diseases 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 208000006881 esophagitis Diseases 0.000 description 2
- 201000005917 gastric ulcer Diseases 0.000 description 2
- 208000021302 gastroesophageal reflux disease Diseases 0.000 description 2
- 208000024798 heartburn Diseases 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 150000001335 aliphatic alkanes Chemical class 0.000 description 1
- 229950003476 aminothiazole Drugs 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 229950002342 bisfentidine Drugs 0.000 description 1
- 239000003610 charcoal Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 229960001340 histamine Drugs 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000012792 lyophilization process Methods 0.000 description 1
- 229940105082 medicinal charcoal Drugs 0.000 description 1
- 238000005374 membrane filtration Methods 0.000 description 1
- FXJAOWANXXJWGJ-UHFFFAOYSA-N n-[4-(2-methyl-1h-imidazol-5-yl)phenyl]-n'-propan-2-ylmethanimidamide Chemical compound C1=CC(NC=NC(C)C)=CC=C1C1=CN=C(C)N1 FXJAOWANXXJWGJ-UHFFFAOYSA-N 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Claims (1)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN201310413033.4A CN103462909B (zh) | 2013-09-12 | 2013-09-12 | 一种注射用尼扎替丁制剂 |
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CN201310413033.4A CN103462909B (zh) | 2013-09-12 | 2013-09-12 | 一种注射用尼扎替丁制剂 |
Publications (2)
Publication Number | Publication Date |
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CN103462909A CN103462909A (zh) | 2013-12-25 |
CN103462909B true CN103462909B (zh) | 2015-03-11 |
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CN201310413033.4A Active CN103462909B (zh) | 2013-09-12 | 2013-09-12 | 一种注射用尼扎替丁制剂 |
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CN (1) | CN103462909B (zh) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104076101A (zh) * | 2014-06-13 | 2014-10-01 | 门毅 | 利用hplc测定尼扎替丁及注射制剂中有关物质的方法 |
CN106137983A (zh) * | 2016-07-29 | 2016-11-23 | 自贡市星星科技有限公司 | 一种尼扎替丁冻干粉针制剂及其制备方法 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1771942A (zh) * | 2005-09-30 | 2006-05-17 | 周卓和 | 尼扎替丁注射剂及其制备方法 |
CN1781482A (zh) * | 2004-12-03 | 2006-06-07 | 成都摩尔生物医药有限公司 | 尼扎替丁冻干粉针制剂及制备方法 |
CN101450046A (zh) * | 2008-07-08 | 2009-06-10 | 黑龙江天行健医药有限公司 | 尼扎替丁冻干粉针注射剂及其制备方法 |
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2013
- 2013-09-12 CN CN201310413033.4A patent/CN103462909B/zh active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1781482A (zh) * | 2004-12-03 | 2006-06-07 | 成都摩尔生物医药有限公司 | 尼扎替丁冻干粉针制剂及制备方法 |
CN1771942A (zh) * | 2005-09-30 | 2006-05-17 | 周卓和 | 尼扎替丁注射剂及其制备方法 |
CN101450046A (zh) * | 2008-07-08 | 2009-06-10 | 黑龙江天行健医药有限公司 | 尼扎替丁冻干粉针注射剂及其制备方法 |
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CN103462909A (zh) | 2013-12-25 |
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Effective date of registration: 20170726 Address after: Huilong town Nanyuan village Qidong city 226200 Jiangsu city of Nantong Province Patentee after: Sun Qingwei Address before: 100021 Beijing city Chaoyang District Jinsong three District No. 302 Huateng building room 1301 Patentee before: Men Yi |
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Effective date of registration: 20180611 Address after: 102212 east side cottage of Beijing Changping District City Xing Shou Town Xing Shou Garden Technology Development Center Patentee after: Beijing Kang Yi Pharmaceutical Co., Ltd. Address before: 226200 Nanyuan new town, Huilong Town, Qidong City, Nantong, Jiangsu Patentee before: Sun Qingwei |