CN104069063A - 盐酸法舒地尔药物组合物及其制备方法 - Google Patents
盐酸法舒地尔药物组合物及其制备方法 Download PDFInfo
- Publication number
- CN104069063A CN104069063A CN201410223649.XA CN201410223649A CN104069063A CN 104069063 A CN104069063 A CN 104069063A CN 201410223649 A CN201410223649 A CN 201410223649A CN 104069063 A CN104069063 A CN 104069063A
- Authority
- CN
- China
- Prior art keywords
- injection
- preparation
- fasudic hydrochloride
- add
- minutes
- 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
- 238000002360 preparation method Methods 0.000 title claims abstract description 27
- 239000008194 pharmaceutical composition Substances 0.000 title abstract description 5
- ZAVGJDAFCZAWSZ-UHFFFAOYSA-N hydroxyfasudil Chemical compound C1=CC=C2C(O)=NC=CC2=C1S(=O)(=O)N1CCCNCC1 ZAVGJDAFCZAWSZ-UHFFFAOYSA-N 0.000 title abstract 3
- 239000007924 injection Substances 0.000 claims abstract description 23
- 238000002347 injection Methods 0.000 claims abstract description 23
- 239000001509 sodium citrate Substances 0.000 claims abstract description 10
- 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 claims abstract description 10
- 239000002552 dosage form Substances 0.000 claims abstract 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 24
- 239000000203 mixture Substances 0.000 claims description 11
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 9
- 238000003756 stirring Methods 0.000 claims description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 8
- 239000000243 solution Substances 0.000 claims description 8
- 238000007689 inspection Methods 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 238000004806 packaging method and process Methods 0.000 claims description 4
- 238000013019 agitation Methods 0.000 claims description 3
- 229910052799 carbon Inorganic materials 0.000 claims description 3
- 238000001514 detection method Methods 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 3
- 239000011265 semifinished product Substances 0.000 claims description 3
- 239000011780 sodium chloride Substances 0.000 claims description 3
- 238000001179 sorption measurement Methods 0.000 claims description 3
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 238000004659 sterilization and disinfection Methods 0.000 claims description 3
- 239000008215 water for injection Substances 0.000 claims description 3
- 238000000034 method Methods 0.000 abstract description 3
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 239000002245 particle Substances 0.000 abstract 1
- 230000000052 comparative effect Effects 0.000 description 12
- 239000013618 particulate matter Substances 0.000 description 12
- 239000000126 substance Substances 0.000 description 7
- NGOGFTYYXHNFQH-UHFFFAOYSA-N fasudil Chemical compound C=1C=CC2=CN=CC=C2C=1S(=O)(=O)N1CCCNCC1 NGOGFTYYXHNFQH-UHFFFAOYSA-N 0.000 description 5
- 229960002435 fasudil Drugs 0.000 description 5
- 239000012895 dilution Substances 0.000 description 4
- 238000010790 dilution Methods 0.000 description 4
- 230000009286 beneficial effect Effects 0.000 description 3
- 210000004556 brain Anatomy 0.000 description 3
- 239000003085 diluting agent Substances 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 239000003381 stabilizer Substances 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000000324 neuroprotective effect Effects 0.000 description 2
- 230000006641 stabilisation Effects 0.000 description 2
- 238000011105 stabilization Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 206010061623 Adverse drug reaction Diseases 0.000 description 1
- 206010002660 Anoxia Diseases 0.000 description 1
- 201000006474 Brain Ischemia Diseases 0.000 description 1
- 206010008120 Cerebral ischaemia Diseases 0.000 description 1
- 208000030453 Drug-Related Side Effects and Adverse reaction Diseases 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- 206010021143 Hypoxia Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 102000011131 Myosin-Light-Chain Phosphatase Human genes 0.000 description 1
- 108010037801 Myosin-Light-Chain Phosphatase Proteins 0.000 description 1
- 208000005392 Spasm Diseases 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- 206010047163 Vasospasm Diseases 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 230000008485 antagonism Effects 0.000 description 1
- 230000006909 anti-apoptosis Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000028600 axonogenesis Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000004958 brain cell Anatomy 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 206010008118 cerebral infarction Diseases 0.000 description 1
- 230000001149 cognitive effect Effects 0.000 description 1
- 210000003792 cranial nerve Anatomy 0.000 description 1
- 230000000916 dilatatory effect Effects 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000008151 electrolyte solution Substances 0.000 description 1
- 210000003725 endotheliocyte Anatomy 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 230000000302 ischemic effect Effects 0.000 description 1
- 230000004089 microcirculation Effects 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 210000002569 neuron Anatomy 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 239000003590 rho kinase inhibitor Substances 0.000 description 1
- 239000008354 sodium chloride injection Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Claims (4)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410223649.XA CN104069063B (zh) | 2014-05-22 | 2014-05-22 | 盐酸法舒地尔药物组合物及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410223649.XA CN104069063B (zh) | 2014-05-22 | 2014-05-22 | 盐酸法舒地尔药物组合物及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN104069063A true CN104069063A (zh) | 2014-10-01 |
CN104069063B CN104069063B (zh) | 2019-03-26 |
Family
ID=51590934
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201410223649.XA Expired - Fee Related CN104069063B (zh) | 2014-05-22 | 2014-05-22 | 盐酸法舒地尔药物组合物及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN104069063B (zh) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105168224A (zh) * | 2015-09-24 | 2015-12-23 | 辰欣药业股份有限公司 | 一种盐酸法舒地尔注射液及其制备方法 |
CN110327292A (zh) * | 2019-08-11 | 2019-10-15 | 天津乾丰瑞科技有限公司 | 一种盐酸法舒地尔注射制剂及其制备方法 |
CN110507608A (zh) * | 2019-10-08 | 2019-11-29 | 四川太平洋药业有限责任公司 | 一种盐酸法舒地尔注射液制备工艺 |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005117896A1 (de) * | 2004-06-03 | 2005-12-15 | Schering Aktiengesellschaft | Formulierungen, die fasudil, eine matrix und einem mantel enthalten |
CN102008433A (zh) * | 2010-12-01 | 2011-04-13 | 广东三信药业有限公司 | 一种改善稳定性的法舒地尔盐注射液及其制备方法 |
CN102266363A (zh) * | 2011-08-08 | 2011-12-07 | 南京泽朗医药科技有限公司 | 同时提取西河柳中总黄酮和总皂苷的工艺 |
CN102525897A (zh) * | 2012-01-17 | 2012-07-04 | 山东罗欣药业股份有限公司 | 一种盐酸法舒地尔组合物注射液及其制备方法 |
CN102973571A (zh) * | 2012-12-12 | 2013-03-20 | 天津红日药业股份有限公司 | 法舒地尔的新用途 |
CN103222953A (zh) * | 2013-05-03 | 2013-07-31 | 成都苑东药业有限公司 | 一种盐酸法舒地尔注射液组合物及其制备方法 |
-
2014
- 2014-05-22 CN CN201410223649.XA patent/CN104069063B/zh not_active Expired - Fee Related
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005117896A1 (de) * | 2004-06-03 | 2005-12-15 | Schering Aktiengesellschaft | Formulierungen, die fasudil, eine matrix und einem mantel enthalten |
CN102008433A (zh) * | 2010-12-01 | 2011-04-13 | 广东三信药业有限公司 | 一种改善稳定性的法舒地尔盐注射液及其制备方法 |
CN102266363A (zh) * | 2011-08-08 | 2011-12-07 | 南京泽朗医药科技有限公司 | 同时提取西河柳中总黄酮和总皂苷的工艺 |
CN102525897A (zh) * | 2012-01-17 | 2012-07-04 | 山东罗欣药业股份有限公司 | 一种盐酸法舒地尔组合物注射液及其制备方法 |
CN102973571A (zh) * | 2012-12-12 | 2013-03-20 | 天津红日药业股份有限公司 | 法舒地尔的新用途 |
CN103222953A (zh) * | 2013-05-03 | 2013-07-31 | 成都苑东药业有限公司 | 一种盐酸法舒地尔注射液组合物及其制备方法 |
Non-Patent Citations (2)
Title |
---|
王冰等: "防范静脉输液中不溶性微粒危害的研究进展", 《上海护理》 * |
袁松范: "注射剂中应用的辅料", 《国外医药——合成药 生化药 制剂分册》 * |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105168224A (zh) * | 2015-09-24 | 2015-12-23 | 辰欣药业股份有限公司 | 一种盐酸法舒地尔注射液及其制备方法 |
CN105168224B (zh) * | 2015-09-24 | 2018-11-13 | 辰欣药业股份有限公司 | 一种盐酸法舒地尔注射液及其制备方法 |
CN110327292A (zh) * | 2019-08-11 | 2019-10-15 | 天津乾丰瑞科技有限公司 | 一种盐酸法舒地尔注射制剂及其制备方法 |
CN110507608A (zh) * | 2019-10-08 | 2019-11-29 | 四川太平洋药业有限责任公司 | 一种盐酸法舒地尔注射液制备工艺 |
Also Published As
Publication number | Publication date |
---|---|
CN104069063B (zh) | 2019-03-26 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN102008727B (zh) | 一种提高川芎嗪药物注射制剂稳定性的注射用药物组合物 | |
CN105106110A (zh) | 一种提高葛根素药物注射制剂稳定性的注射用药物组合物 | |
CN106061467A (zh) | 用于产生去甲肾上腺素的稳定低浓度、可注射溶液的方法 | |
CN101991589A (zh) | 一种甘油果糖注射液及其制备方法 | |
CN1729985A (zh) | 盐酸法舒地尔注射液及其制备方法 | |
CN104069063A (zh) | 盐酸法舒地尔药物组合物及其制备方法 | |
CN105125485A (zh) | 一种提高葛根素药物注射制剂稳定性注射药物的制备方法 | |
CN105919931A (zh) | 一种稳定的盐酸法舒地尔注射液及其制备方法 | |
CN104208020B (zh) | 一种盐酸罗哌卡因注射液及其制备方法 | |
CN106959347B (zh) | 环磷腺苷葡胺注射液药物组合物的质控方法 | |
CN102836123A (zh) | 一种含有左乙拉西坦活性成分的注射剂及其制备工艺 | |
CN104706655B (zh) | 注射用环磷腺苷葡胺粉针剂药物组合物和制法 | |
CN108324683A (zh) | 一种稳定的大输液依达拉奉注射液及其制备工艺 | |
CN102068408A (zh) | 一种盐酸法舒地尔注射液及其制备方法 | |
CN104188902B (zh) | 一种高稳定性达肝素钠注射液的生产工艺 | |
CN106109401A (zh) | 一种高纯度氨甲环酸注射剂及其制备方法以及在心脏外科手术体外循环围术期适应症的应用 | |
CN101491495B (zh) | 丹酚酸b镁注射剂、制备方法及应用 | |
CN106361969A (zh) | 一种提高参麦药物注射制剂稳定性药物组合物的制备方法 | |
CN106074366B (zh) | 治疗脑外伤及脑手术后意识障碍的注射液及其制备方法 | |
CN100509787C (zh) | 吡硫醇的新的药学上可接受的盐及其制备方法 | |
CN106389315A (zh) | 一种提高益智仁药物注射制剂稳定性的注射用药物组合物 | |
CN102652755A (zh) | 一种甘油果糖氯化钠注射液及制备方法 | |
CN106474056A (zh) | 一种提高叶黄素药物注射制剂稳定性的注射用药物组合物 | |
CN101121696B (zh) | 吡硫醇的金属盐及其水合物 | |
CN112545982A (zh) | 一种双嘧达莫制备的大容量注射剂及其制备方法 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
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: 20170105 Address after: 100022 Beijing Jianguo Road No. 93, building 12, building 1901, No. Applicant after: XIZANG JIURUI HEALTH Co.,Ltd. Address before: Room 12, building 93, Wanda Plaza, No. 100022 Jianguo Road, Beijing, Chaoyang District, China Applicant before: An Dong |
|
DD01 | Delivery of document by public notice |
Addressee: XIZANG JIURUI HEALTH Co.,Ltd. Document name: Notification of Passing Examination on Formalities |
|
DD01 | Delivery of document by public notice | ||
GR01 | Patent grant | ||
GR01 | Patent grant | ||
CP01 | Change in the name or title of a patent holder | ||
CP01 | Change in the name or title of a patent holder |
Address after: 100022 Beijing Jianguo Road No. 93, building 12, building 1901, No. Patentee after: JIURUI health Co.,Ltd. Address before: 100022 Beijing Jianguo Road No. 93, building 12, building 1901, No. Patentee before: XIZANG JIURUI HEALTH Co.,Ltd. |
|
CF01 | Termination of patent right due to non-payment of annual fee | ||
CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20190326 Termination date: 20210522 |