CN102716064A - 一种长春西汀注射液及其生产方法 - Google Patents
一种长春西汀注射液及其生产方法 Download PDFInfo
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- CN102716064A CN102716064A CN2011103597985A CN201110359798A CN102716064A CN 102716064 A CN102716064 A CN 102716064A CN 2011103597985 A CN2011103597985 A CN 2011103597985A CN 201110359798 A CN201110359798 A CN 201110359798A CN 102716064 A CN102716064 A CN 102716064A
- Authority
- CN
- China
- Prior art keywords
- vinpocetine
- injection
- water
- acid
- cosolvent
- 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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- DDNCQMVWWZOMLN-IRLDBZIGSA-N Vinpocetine Chemical compound C1=CC=C2C(CCN3CCC4)=C5[C@@H]3[C@]4(CC)C=C(C(=O)OCC)N5C2=C1 DDNCQMVWWZOMLN-IRLDBZIGSA-N 0.000 title claims abstract description 90
- 229960000744 vinpocetine Drugs 0.000 title claims abstract description 90
- 238000002347 injection Methods 0.000 title claims abstract description 55
- 239000007924 injection Substances 0.000 title claims abstract description 55
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 14
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims abstract description 70
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 52
- 238000003756 stirring Methods 0.000 claims abstract description 47
- 239000008215 water for injection Substances 0.000 claims abstract description 43
- 235000010323 ascorbic acid Nutrition 0.000 claims abstract description 35
- 239000011668 ascorbic acid Substances 0.000 claims abstract description 35
- 229960005070 ascorbic acid Drugs 0.000 claims abstract description 35
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims abstract description 24
- 239000011975 tartaric acid Substances 0.000 claims abstract description 24
- 235000002906 tartaric acid Nutrition 0.000 claims abstract description 24
- 230000001954 sterilising effect Effects 0.000 claims abstract description 19
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 19
- 239000006184 cosolvent Substances 0.000 claims abstract description 17
- 238000006392 deoxygenation reaction Methods 0.000 claims abstract description 16
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims abstract description 15
- 229910052799 carbon Inorganic materials 0.000 claims abstract description 15
- 239000000243 solution Substances 0.000 claims abstract description 11
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims abstract description 8
- 239000000203 mixture Substances 0.000 claims abstract description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 33
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 30
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 15
- 229910052757 nitrogen Inorganic materials 0.000 claims description 15
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 10
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 10
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 10
- 235000011054 acetic acid Nutrition 0.000 claims description 5
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 5
- 239000004310 lactic acid Substances 0.000 claims description 5
- 235000014655 lactic acid Nutrition 0.000 claims description 5
- 235000015165 citric acid Nutrition 0.000 claims description 3
- 235000011167 hydrochloric acid Nutrition 0.000 claims description 2
- 238000002474 experimental method Methods 0.000 abstract description 5
- 239000003814 drug Substances 0.000 abstract description 4
- 239000002253 acid Substances 0.000 abstract description 2
- 150000007513 acids Chemical class 0.000 abstract description 2
- 239000002245 particle Substances 0.000 abstract description 2
- 238000004090 dissolution Methods 0.000 abstract 2
- 229940079593 drug Drugs 0.000 abstract 1
- 238000001914 filtration Methods 0.000 abstract 1
- 238000010438 heat treatment Methods 0.000 abstract 1
- 239000011259 mixed solution Substances 0.000 abstract 1
- 238000001179 sorption measurement Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 description 33
- 238000012360 testing method Methods 0.000 description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 239000000126 substance Substances 0.000 description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 4
- 235000010262 sodium metabisulphite Nutrition 0.000 description 4
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 description 3
- 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 3
- 210000004556 brain Anatomy 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 238000001514 detection method Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000007254 oxidation reaction Methods 0.000 description 3
- 239000013618 particulate matter Substances 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 239000000600 sorbitol Substances 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- 239000003963 antioxidant agent Substances 0.000 description 2
- 235000006708 antioxidants Nutrition 0.000 description 2
- 208000026106 cerebrovascular disease Diseases 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 2
- 230000003647 oxidation Effects 0.000 description 2
- 238000010525 oxidative degradation reaction Methods 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 239000000377 silicon dioxide Substances 0.000 description 2
- SGTNSNPWRIOYBX-UHFFFAOYSA-N 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile Chemical compound C1=C(OC)C(OC)=CC=C1CCN(C)CCCC(C#N)(C(C)C)C1=CC=C(OC)C(OC)=C1 SGTNSNPWRIOYBX-UHFFFAOYSA-N 0.000 description 1
- OZDNDGXASTWERN-CTNGQTDRSA-N Apovincamine Chemical compound C1=CC=C2C(CCN3CCC4)=C5[C@@H]3[C@]4(CC)C=C(C(=O)OC)N5C2=C1 OZDNDGXASTWERN-CTNGQTDRSA-N 0.000 description 1
- 208000014644 Brain disease Diseases 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010065559 Cerebral arteriosclerosis Diseases 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 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 1
- 206010021143 Hypoxia Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- WEVYAHXRMPXWCK-UHFFFAOYSA-N acetonitrile Substances CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 235000019257 ammonium acetate Nutrition 0.000 description 1
- 230000003026 anti-oxygenic effect Effects 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 229950006936 apovincamine Drugs 0.000 description 1
- OZDNDGXASTWERN-UHFFFAOYSA-N apovincamine Natural products C1=CC=C2C(CCN3CCC4)=C5C3C4(CC)C=C(C(=O)OC)N5C2=C1 OZDNDGXASTWERN-UHFFFAOYSA-N 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 235000019445 benzyl alcohol Nutrition 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 229940088033 calan Drugs 0.000 description 1
- 206010008118 cerebral infarction Diseases 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000037149 energy metabolism Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- RTZKZFJDLAIYFH-UHFFFAOYSA-N ether Substances CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 150000002475 indoles Chemical class 0.000 description 1
- 201000005851 intracranial arteriosclerosis Diseases 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000002858 neurotransmitter agent Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 150000003222 pyridines Chemical class 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000011003 system suitability test Methods 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (6)
Priority Applications (1)
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CN201110359798.5A CN102716064B (zh) | 2011-11-14 | 2011-11-14 | 一种长春西汀注射液及其生产方法 |
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CN201110359798.5A CN102716064B (zh) | 2011-11-14 | 2011-11-14 | 一种长春西汀注射液及其生产方法 |
Publications (2)
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CN102716064A true CN102716064A (zh) | 2012-10-10 |
CN102716064B CN102716064B (zh) | 2014-04-09 |
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CN201110359798.5A Active CN102716064B (zh) | 2011-11-14 | 2011-11-14 | 一种长春西汀注射液及其生产方法 |
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101066244A (zh) * | 2006-09-28 | 2007-11-07 | 郑州羚锐制药有限公司 | 长春西汀小容量注射剂及其制备工艺 |
CN101889978A (zh) * | 2010-04-29 | 2010-11-24 | 袁璐 | 含有长春西汀的药用组合物及其制备方法和应用 |
CN101991530A (zh) * | 2009-08-28 | 2011-03-30 | 沈阳志鹰制药厂 | 含有长春西汀大容量氯化钠注射剂及其制备方法 |
CN102091030A (zh) * | 2011-01-20 | 2011-06-15 | 罗军 | 长春西汀注射液及其制备方法 |
CN102113994A (zh) * | 2010-01-04 | 2011-07-06 | 长春富春制药有限公司 | 一种脑血管扩张药及其制备方法 |
-
2011
- 2011-11-14 CN CN201110359798.5A patent/CN102716064B/zh active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101066244A (zh) * | 2006-09-28 | 2007-11-07 | 郑州羚锐制药有限公司 | 长春西汀小容量注射剂及其制备工艺 |
CN101991530A (zh) * | 2009-08-28 | 2011-03-30 | 沈阳志鹰制药厂 | 含有长春西汀大容量氯化钠注射剂及其制备方法 |
CN102113994A (zh) * | 2010-01-04 | 2011-07-06 | 长春富春制药有限公司 | 一种脑血管扩张药及其制备方法 |
CN101889978A (zh) * | 2010-04-29 | 2010-11-24 | 袁璐 | 含有长春西汀的药用组合物及其制备方法和应用 |
CN102091030A (zh) * | 2011-01-20 | 2011-06-15 | 罗军 | 长春西汀注射液及其制备方法 |
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C06 | Publication | ||
PB01 | Publication | ||
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C14 | Grant of patent or utility model | ||
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 vinpocetine injection and its production method Effective date of registration: 20230222 Granted publication date: 20140409 Pledgee: CITIC Bank Limited by Share Ltd. Zhengzhou branch Pledgor: HENAN RUNHONG PHARMACEUTICAL Co.,Ltd. Registration number: Y2023980033250 |
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PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
PC01 | Cancellation of the registration of the contract for pledge of patent right |
Granted publication date: 20140409 Pledgee: CITIC Bank Limited by Share Ltd. Zhengzhou branch Pledgor: HENAN RUNHONG PHARMACEUTICAL Co.,Ltd. Registration number: Y2023980033250 |
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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: A Changchun Xiting Injection and Its Production Method Granted publication date: 20140409 Pledgee: CITIC Bank Limited by Share Ltd. Zhengzhou branch Pledgor: HENAN RUNHONG PHARMACEUTICAL Co.,Ltd. Registration number: Y2024980003580 |