CN104013586A - 一种注射用兰索拉唑冻干粉针剂的制备工艺 - Google Patents
一种注射用兰索拉唑冻干粉针剂的制备工艺 Download PDFInfo
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- CN104013586A CN104013586A CN201410276117.2A CN201410276117A CN104013586A CN 104013586 A CN104013586 A CN 104013586A CN 201410276117 A CN201410276117 A CN 201410276117A CN 104013586 A CN104013586 A CN 104013586A
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- China
- Prior art keywords
- injection
- lansoprazole
- freeze
- condition
- under
- 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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Links
- 229960003174 lansoprazole Drugs 0.000 title claims abstract description 59
- 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 title claims abstract description 59
- 239000007924 injection Substances 0.000 title claims abstract description 31
- 238000002347 injection Methods 0.000 title claims abstract description 31
- 238000002360 preparation method Methods 0.000 title claims abstract description 11
- 239000000843 powder Substances 0.000 title abstract 4
- 239000000243 solution Substances 0.000 claims abstract description 27
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 22
- 238000001914 filtration Methods 0.000 claims abstract description 17
- 238000003756 stirring Methods 0.000 claims abstract description 15
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 13
- 229930195725 Mannitol Natural products 0.000 claims abstract description 13
- 239000000594 mannitol Substances 0.000 claims abstract description 13
- 235000010355 mannitol Nutrition 0.000 claims abstract description 13
- 229910052799 carbon Inorganic materials 0.000 claims abstract description 12
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 claims abstract description 11
- 229960003194 meglumine Drugs 0.000 claims abstract description 11
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims abstract description 9
- 239000000706 filtrate Substances 0.000 claims abstract description 9
- 239000003513 alkali Substances 0.000 claims abstract description 7
- 238000004321 preservation Methods 0.000 claims abstract description 7
- 239000008215 water for injection Substances 0.000 claims description 14
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 claims description 11
- 239000012982 microporous membrane Substances 0.000 claims description 11
- 238000005516 engineering process Methods 0.000 claims description 9
- 238000001035 drying Methods 0.000 claims description 8
- 238000009413 insulation Methods 0.000 claims description 7
- 230000001186 cumulative effect Effects 0.000 claims description 6
- 238000004821 distillation Methods 0.000 claims description 6
- 230000033228 biological regulation Effects 0.000 claims description 5
- 230000014759 maintenance of location Effects 0.000 claims description 5
- 238000000859 sublimation Methods 0.000 claims description 5
- 230000008022 sublimation Effects 0.000 claims description 5
- 229940090044 injection Drugs 0.000 abstract description 23
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 abstract description 11
- 238000000034 method Methods 0.000 abstract description 9
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 abstract description 7
- 229940093181 glucose injection Drugs 0.000 abstract description 7
- 239000001540 sodium lactate Substances 0.000 abstract description 7
- 229940005581 sodium lactate Drugs 0.000 abstract description 7
- 235000011088 sodium lactate Nutrition 0.000 abstract description 7
- 239000008354 sodium chloride injection Substances 0.000 abstract description 6
- 239000012528 membrane Substances 0.000 abstract description 3
- 238000010438 heat treatment Methods 0.000 abstract description 2
- 239000002904 solvent Substances 0.000 abstract description 2
- 239000011148 porous material Substances 0.000 abstract 4
- 238000001816 cooling Methods 0.000 abstract 1
- 238000007865 diluting Methods 0.000 abstract 1
- 238000011049 filling Methods 0.000 abstract 1
- 238000004108 freeze drying Methods 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 24
- 229960001855 mannitol Drugs 0.000 description 11
- 239000013618 particulate matter Substances 0.000 description 8
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 description 6
- 239000008156 Ringer's lactate solution Substances 0.000 description 6
- BMLSTPRTEKLIPM-UHFFFAOYSA-I calcium;potassium;disodium;hydrogen carbonate;dichloride;dihydroxide;hydrate Chemical compound O.[OH-].[OH-].[Na+].[Na+].[Cl-].[Cl-].[K+].[Ca+2].OC([O-])=O BMLSTPRTEKLIPM-UHFFFAOYSA-I 0.000 description 6
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 description 6
- 238000012856 packing Methods 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 239000002671 adjuvant Substances 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 239000008103 glucose Substances 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 3
- 238000007689 inspection Methods 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 229920001983 poloxamer Polymers 0.000 description 3
- 230000000630 rising effect Effects 0.000 description 3
- 239000001509 sodium citrate Substances 0.000 description 3
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 3
- 235000010265 sodium sulphite Nutrition 0.000 description 3
- 238000005261 decarburization Methods 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 239000003381 stabilizer Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 208000007107 Stomach Ulcer Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 238000005352 clarification Methods 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 201000005917 gastric ulcer Diseases 0.000 description 1
- 208000021302 gastroesophageal reflux disease Diseases 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 208000000689 peptic esophagitis Diseases 0.000 description 1
- 229940126409 proton pump inhibitor Drugs 0.000 description 1
- 239000000612 proton pump inhibitor Substances 0.000 description 1
- 239000011265 semifinished product Substances 0.000 description 1
- 229940083608 sodium hydroxide Drugs 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
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Priority Applications (1)
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CN201410276117.2A CN104013586B (zh) | 2014-06-19 | 2014-06-19 | 一种注射用兰索拉唑冻干粉针剂及其制备工艺 |
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CN201410276117.2A CN104013586B (zh) | 2014-06-19 | 2014-06-19 | 一种注射用兰索拉唑冻干粉针剂及其制备工艺 |
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CN104013586A true CN104013586A (zh) | 2014-09-03 |
CN104013586B CN104013586B (zh) | 2015-04-22 |
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105267162A (zh) * | 2015-11-29 | 2016-01-27 | 南京多宝生物科技有限公司 | 一种治疗脑梗塞的注射用奥扎格雷钠冻干粉 |
CN105343017A (zh) * | 2015-12-01 | 2016-02-24 | 李正梅 | 一种抗菌的注射用头孢美唑钠冻干粉 |
CN109394706A (zh) * | 2018-12-07 | 2019-03-01 | 杭州上禾健康科技有限公司 | 一种注射用兰索拉唑冻干粉及其制备方法 |
CN113069421A (zh) * | 2021-03-29 | 2021-07-06 | 海南锦瑞制药有限公司 | 注射用兰索拉唑 |
CN115919783A (zh) * | 2022-11-24 | 2023-04-07 | 海南锦瑞制药有限公司 | 一种注射用兰索拉唑冻干粉针剂及其制备方法 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101229136A (zh) * | 2008-01-18 | 2008-07-30 | 山东罗欣药业股份有限公司 | 一种注射用兰索拉唑冻干粉及其制备方法 |
CN101502493A (zh) * | 2009-03-23 | 2009-08-12 | 悦康药业集团有限公司 | 一种注射用兰索拉唑冻干粉针剂的制备方法 |
CN103705473A (zh) * | 2013-12-26 | 2014-04-09 | 山东博迈康药物研究有限公司 | 一种兰索拉唑冻干粉针剂及其制备方法 |
-
2014
- 2014-06-19 CN CN201410276117.2A patent/CN104013586B/zh active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101229136A (zh) * | 2008-01-18 | 2008-07-30 | 山东罗欣药业股份有限公司 | 一种注射用兰索拉唑冻干粉及其制备方法 |
CN101502493A (zh) * | 2009-03-23 | 2009-08-12 | 悦康药业集团有限公司 | 一种注射用兰索拉唑冻干粉针剂的制备方法 |
CN103705473A (zh) * | 2013-12-26 | 2014-04-09 | 山东博迈康药物研究有限公司 | 一种兰索拉唑冻干粉针剂及其制备方法 |
Non-Patent Citations (1)
Title |
---|
刘昔平等: "注射用兰索拉唑冻干工艺研究", 《科技创业》, no. 11, 31 December 2013 (2013-12-31), pages 187 - 188 * |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105267162A (zh) * | 2015-11-29 | 2016-01-27 | 南京多宝生物科技有限公司 | 一种治疗脑梗塞的注射用奥扎格雷钠冻干粉 |
CN105343017A (zh) * | 2015-12-01 | 2016-02-24 | 李正梅 | 一种抗菌的注射用头孢美唑钠冻干粉 |
CN109394706A (zh) * | 2018-12-07 | 2019-03-01 | 杭州上禾健康科技有限公司 | 一种注射用兰索拉唑冻干粉及其制备方法 |
CN113069421A (zh) * | 2021-03-29 | 2021-07-06 | 海南锦瑞制药有限公司 | 注射用兰索拉唑 |
CN115919783A (zh) * | 2022-11-24 | 2023-04-07 | 海南锦瑞制药有限公司 | 一种注射用兰索拉唑冻干粉针剂及其制备方法 |
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CN104013586B (zh) | 2015-04-22 |
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Effective date of registration: 20160509 Address after: Huankeyuan Tea Road 214205 Jiangsu city of Yixing province No. 18 Patentee after: JIANGSU JINSILI PHARMACEUTICAL CO.,LTD. Address before: 200240 Shanghai city Minhang District Jianchuan Road No. 951 Building 5 floor 2 Room 203 Patentee before: SHANGHAI CIRUI MEDICAL TECHNOLOGY CO.,LTD. |
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Effective date of registration: 20170711 Address after: 201108 room 2, building 598, Guanghua Road, Shanghai, Minhang District, Patentee after: SHANGHAI CIRUI MEDICINE TECHNOLOGY CO.,LTD. Address before: Huankeyuan Tea Road 214205 Jiangsu city of Yixing province No. 18 Patentee before: JIANGSU JINSILI PHARMACEUTICAL CO.,LTD. |
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Effective date of registration: 20210204 Address after: 214200 No.18 chaquan Road, huankeyuan, Yixing City, Wuxi City, Jiangsu Province Patentee after: JIANGSU KINGSLEY PHARMACEUTICAL Co.,Ltd. Address before: 201108 room b2116, building 2, 598 Guanghua Road, Minhang District, Shanghai Patentee before: SHANGHAI CIRUI MEDICINE TECHNOLOGY Co.,Ltd. |
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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: Lansoprazole freeze-dried powder for injection and its preparation process Effective date of registration: 20230530 Granted publication date: 20150422 Pledgee: Bank of China Limited Yixing branch Pledgor: JIANGSU KINGSLEY PHARMACEUTICAL CO.,LTD. Registration number: Y2023980042280 |