CN1931139A - 注射用盐酸川芎嗪冻干剂及其制备方法 - Google Patents
注射用盐酸川芎嗪冻干剂及其制备方法 Download PDFInfo
- Publication number
- CN1931139A CN1931139A CN 200610150893 CN200610150893A CN1931139A CN 1931139 A CN1931139 A CN 1931139A CN 200610150893 CN200610150893 CN 200610150893 CN 200610150893 A CN200610150893 A CN 200610150893A CN 1931139 A CN1931139 A CN 1931139A
- Authority
- CN
- China
- Prior art keywords
- injection
- preparation
- ligustrazine
- hydrochloride
- ligustrazine hydrochloride
- 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.)
- Granted
Links
- RQKFOGXUTRDQPB-UHFFFAOYSA-N hydron;2,3,5,6-tetramethylpyrazine;chloride Chemical compound Cl.CC1=NC(C)=C(C)N=C1C RQKFOGXUTRDQPB-UHFFFAOYSA-N 0.000 title claims abstract description 31
- 238000002347 injection Methods 0.000 title claims abstract description 15
- 239000007924 injection Substances 0.000 title claims abstract description 15
- 238000000034 method Methods 0.000 title description 2
- 230000008569 process Effects 0.000 title description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 35
- 238000002360 preparation method Methods 0.000 claims abstract description 33
- 229910052799 carbon Inorganic materials 0.000 claims abstract description 20
- 239000000243 solution Substances 0.000 claims abstract description 19
- 238000001914 filtration Methods 0.000 claims abstract description 13
- 238000012856 packing Methods 0.000 claims abstract description 13
- 238000003756 stirring Methods 0.000 claims abstract description 13
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims abstract description 12
- 239000012528 membrane Substances 0.000 claims abstract description 12
- 239000008215 water for injection Substances 0.000 claims abstract description 12
- 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 claims abstract description 8
- 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 8
- 229920002307 Dextran Polymers 0.000 claims abstract description 8
- 229930195725 Mannitol Natural products 0.000 claims abstract description 8
- 239000000594 mannitol Substances 0.000 claims abstract description 8
- 235000010355 mannitol Nutrition 0.000 claims abstract description 8
- 239000000600 sorbitol Substances 0.000 claims abstract description 8
- 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 claims abstract description 4
- FINHMKGKINIASC-UHFFFAOYSA-N Tetramethylpyrazine Chemical compound CC1=NC(C)=C(C)N=C1C FINHMKGKINIASC-UHFFFAOYSA-N 0.000 claims description 16
- 238000010792 warming Methods 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 13
- 238000004108 freeze drying Methods 0.000 claims description 12
- 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
- 238000007689 inspection Methods 0.000 claims description 11
- 239000007788 liquid Substances 0.000 claims description 11
- 238000011068 loading method Methods 0.000 claims description 11
- 238000005303 weighing Methods 0.000 claims description 11
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 8
- 239000002671 adjuvant Substances 0.000 claims description 8
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 238000007710 freezing Methods 0.000 claims description 3
- 210000004907 gland Anatomy 0.000 claims description 3
- 238000010438 heat treatment Methods 0.000 abstract description 9
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 abstract description 5
- 239000003814 drug Substances 0.000 abstract description 2
- 239000000463 material Substances 0.000 abstract 1
- 238000005352 clarification Methods 0.000 description 27
- 238000001035 drying Methods 0.000 description 24
- 230000008859 change Effects 0.000 description 9
- 238000005057 refrigeration Methods 0.000 description 8
- 239000007787 solid Substances 0.000 description 8
- 239000008363 phosphate buffer Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 206010008132 Cerebral thrombosis Diseases 0.000 description 1
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 1
- 201000001429 Intracranial Thrombosis Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 229930013930 alkaloid Natural products 0.000 description 1
- 150000003797 alkaloid derivatives Chemical class 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 230000000702 anti-platelet effect Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 206010008118 cerebral infarction Diseases 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000004089 microcirculation Effects 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 208000019553 vascular disease Diseases 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
批号 | 时间(月) | 性状 | 溶液的澄清度与颜色 | 酸度 | 有关物质(%) | 澄明度 | 含量(%) |
001204001205001206 | 013612182430360136121824303601361218243036 | 白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物白色块状物 | 澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色澄清无色 | 3.303.303.293.273.283.263.273.263.263.283.273.263.283.263.243.253.243.253.303.243.273.283.313.303.283.273.28 | 0.0140.0200.0190.0180.0180.0230.0360.0530.0660.0140.0140.0140.0200.0180.0270.0410.0590.0710.0120.0120.0170.0210.0200.0240.0340.0470.057 | 符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定符合规定 | 100.599.399.8100.299.499.199.098.498.399.499.099.499.599.299.098.698.498.298.798.398.898.298.498.298.098.197.7 |
Claims (1)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2006101508933A CN100528141C (zh) | 2006-10-13 | 2006-10-13 | 注射用盐酸川芎嗪冻干剂及其制备方法 |
Applications Claiming Priority (1)
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CNB2006101508933A CN100528141C (zh) | 2006-10-13 | 2006-10-13 | 注射用盐酸川芎嗪冻干剂及其制备方法 |
Publications (2)
Publication Number | Publication Date |
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CN1931139A true CN1931139A (zh) | 2007-03-21 |
CN100528141C CN100528141C (zh) | 2009-08-19 |
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101961310A (zh) * | 2010-09-15 | 2011-02-02 | 河南辅仁怀庆堂制药有限公司 | 盐酸川芎嗪注射液配制工艺 |
CN101647781B (zh) * | 2009-09-03 | 2011-06-29 | 海南新中正制药有限公司 | 注射用磷酸川芎嗪粉针的制备方法 |
CN104173299A (zh) * | 2014-08-29 | 2014-12-03 | 湖南科伦制药有限公司 | 一种注射用盐酸川芎嗪的冷冻干燥方法 |
CN105078907A (zh) * | 2015-08-18 | 2015-11-25 | 北京四环科宝制药有限公司 | 注射用盐酸川芎嗪冻干制剂的冷冻干燥方法 |
CN105213328A (zh) * | 2015-11-10 | 2016-01-06 | 瑞阳制药有限公司 | 注射用磷酸川芎嗪冻干粉针及其制备方法 |
-
2006
- 2006-10-13 CN CNB2006101508933A patent/CN100528141C/zh active Active
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101647781B (zh) * | 2009-09-03 | 2011-06-29 | 海南新中正制药有限公司 | 注射用磷酸川芎嗪粉针的制备方法 |
CN101961310A (zh) * | 2010-09-15 | 2011-02-02 | 河南辅仁怀庆堂制药有限公司 | 盐酸川芎嗪注射液配制工艺 |
CN104173299A (zh) * | 2014-08-29 | 2014-12-03 | 湖南科伦制药有限公司 | 一种注射用盐酸川芎嗪的冷冻干燥方法 |
CN104173299B (zh) * | 2014-08-29 | 2017-06-13 | 湖南科伦制药有限公司 | 一种注射用盐酸川芎嗪的冷冻干燥方法 |
CN105078907A (zh) * | 2015-08-18 | 2015-11-25 | 北京四环科宝制药有限公司 | 注射用盐酸川芎嗪冻干制剂的冷冻干燥方法 |
CN105078907B (zh) * | 2015-08-18 | 2018-09-21 | 北京四环科宝制药有限公司 | 注射用盐酸川芎嗪冻干制剂的冷冻干燥方法 |
CN105213328A (zh) * | 2015-11-10 | 2016-01-06 | 瑞阳制药有限公司 | 注射用磷酸川芎嗪冻干粉针及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN100528141C (zh) | 2009-08-19 |
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Legal Events
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C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C41 | Transfer of patent application or patent right or utility model | ||
TA01 | Transfer of patent application right |
Effective date of registration: 20090123 Address after: Room 6304, office building, Jinhua sea logistics center, 14A, Hainan, Hainan Yangpu Economic Development Zone, zip code: 570125 Applicant after: Hainan four ring Pharmaceutical Co., Ltd. Co-applicant after: Sihuan Research Institute of Cardiovascular and Cerebrovascular Medicine Co., Ltd. Address before: Room 1301, room 172, No. 150040, Nangang, Harbin District, Heilongjiang, Zhongshan Road Applicant before: Guo Weicheng |
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ASS | Succession or assignment of patent right |
Owner name: HAINAN SIHUAN PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: GUO WEICHENG Effective date: 20090123 |
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C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
ASS | Succession or assignment of patent right |
Owner name: SHENZHEN SIHUAN PHARMACEUTICAL CO., LTD. TONGHUA S Free format text: FORMER OWNER: SHENZHEN SIHUAN PHARMACEUTICAL CO., LTD. Effective date: 20130206 |
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C41 | Transfer of patent application or patent right or utility model | ||
COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 570125 HAIKOU, HAINAN PROVINCE TO: 578001 DANZHOU, HAINAN PROVINCE |
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TR01 | Transfer of patent right |
Effective date of registration: 20130206 Address after: 578001, Hainan Yangpu Economic Development Zone, Ocean Road west side of the property market building on the third floor, room 304 Patentee after: Hainan Sihuan Pharmaceutical Co.,Ltd Patentee after: Sihuan Research Institute of Cardiovascular and Cerebrovascular Medicine Co., Ltd. Patentee after: Tonghua Sihuan Pharm Co., Ltd. Address before: 570125, Hainan Yangpu Economic Development Zone 14A Hainan Jinhua sea logistics center office building, room 6304 Patentee before: Hainan Sihuan Pharmaceutical Co.,Ltd Patentee before: Sihuan Research Institute of Cardiovascular and Cerebrovascular Medicine Co., Ltd. |
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C56 | Change in the name or address of the patentee | ||
CP01 | Change in the name or title of a patent holder |
Address after: 578001, Hainan Yangpu Economic Development Zone, Ocean Road west side of the property market building on the third floor, room 304 Patentee after: Hainan Sihuan Pharmaceutical Co.,Ltd Patentee after: Sihuan Research Institute of Cardiovascular and Cerebrovascular Medicine Co., Ltd. Patentee after: Tonghua Jida Pharmaceutical Co., Ltd. Address before: 578001, Hainan Yangpu Economic Development Zone, Ocean Road west side of the property market building on the third floor, room 304 Patentee before: Hainan Sihuan Pharmaceutical Co.,Ltd Patentee before: Sihuan Research Institute of Cardiovascular and Cerebrovascular Medicine Co., Ltd. Patentee before: Tonghua Sihuan Pharm Co., Ltd. |
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DD01 | Delivery of document by public notice |
Addressee: Beijing Sihuan Pharmaceutical Co., Ltd. Document name: Notification of Approving Refund |
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EE01 | Entry into force of recordation of patent licensing contract |
Application publication date: 20070321 Assignee: MEDISAN PHARMACEUTICAL CO., LTD. HARBIN Assignor: Hainan Sihuan Pharmaceutical Co. Ltd.|Shenzhen Sihuan Pharmaceutical Co. Ltd.|Tonghua Jida Pharmaceutical Co. Ltd. Contract record no.: 2015230000012 Denomination of invention: Freeze dried ligustrazine hydrochloride prepn for injection and its prepn process Granted publication date: 20090819 License type: Common License Record date: 20150216 |
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EC01 | Cancellation of recordation of patent licensing contract |
Assignee: HARBIN MEDISAN PHARMACEUTICAL Co.,Ltd. Assignor: Hainan Sihuan Pharmaceutical Co., Ltd.|Shenzhen Sihuan Pharmaceutical Co., Ltd.| Tonghua Jida Pharmaceutical Co., Ltd Contract record no.: 2015230000012 Date of cancellation: 20200324 |
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EC01 | Cancellation of recordation of patent licensing contract | ||
EE01 | Entry into force of recordation of patent licensing contract |
Application publication date: 20070321 Assignee: HARBIN MEDISAN PHARMACEUTICAL Co.,Ltd. Assignor: Hainan Sihuan Pharmaceutical Co., Ltd.| Shenzhen Sihuan Pharmaceutical Co., Ltd.|Tonghua Jida Pharmaceutical Co., Ltd Contract record no.: X2020230000001 Denomination of invention: Freeze dried ligustrazine hydrochloride prepn for injection and its prepn process Granted publication date: 20090819 License type: Common License Record date: 20200327 |
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