CN1634002A - 注射用盐酸艾司洛尔冻干粉针剂及其制备方法 - Google Patents
注射用盐酸艾司洛尔冻干粉针剂及其制备方法 Download PDFInfo
- Publication number
- CN1634002A CN1634002A CN 200410065786 CN200410065786A CN1634002A CN 1634002 A CN1634002 A CN 1634002A CN 200410065786 CN200410065786 CN 200410065786 CN 200410065786 A CN200410065786 A CN 200410065786A CN 1634002 A CN1634002 A CN 1634002A
- Authority
- CN
- China
- Prior art keywords
- injection
- esmolol hydrochloride
- water
- esmolol
- freeze
- 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
- 239000000843 powder Substances 0.000 title claims abstract description 90
- VZTMYLWJKCAXMZ-UHFFFAOYSA-N 2-[(2-chloroquinazolin-4-yl)amino]ethanol Chemical compound C1=CC=C2C(NCCO)=NC(Cl)=NC2=C1 VZTMYLWJKCAXMZ-UHFFFAOYSA-N 0.000 title claims abstract description 71
- 229960001015 esmolol hydrochloride Drugs 0.000 title claims abstract description 71
- 239000007924 injection Substances 0.000 title claims abstract description 61
- 238000002347 injection Methods 0.000 title claims abstract description 61
- 238000002360 preparation method Methods 0.000 title claims abstract description 55
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 67
- 239000008215 water for injection Substances 0.000 claims abstract description 51
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 25
- 238000000034 method Methods 0.000 claims abstract description 4
- 239000000243 solution Substances 0.000 claims description 55
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 54
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 44
- 238000001035 drying Methods 0.000 claims description 35
- 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 description 20
- 229930195725 Mannitol Natural products 0.000 claims description 20
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 20
- 239000000594 mannitol Substances 0.000 claims description 20
- 235000010355 mannitol Nutrition 0.000 claims description 20
- 239000007788 liquid Substances 0.000 claims description 18
- 239000002994 raw material Substances 0.000 claims description 18
- 238000000859 sublimation Methods 0.000 claims description 18
- 230000008022 sublimation Effects 0.000 claims description 18
- 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 16
- 238000001914 filtration Methods 0.000 claims description 16
- 238000004108 freeze drying Methods 0.000 claims description 16
- 239000012982 microporous membrane Substances 0.000 claims description 16
- 238000012856 packing Methods 0.000 claims description 16
- 229920002307 Dextran Polymers 0.000 claims description 11
- 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 description 10
- 239000011780 sodium chloride Substances 0.000 claims description 10
- 239000000600 sorbitol Substances 0.000 claims description 10
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 9
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 9
- 239000008103 glucose Substances 0.000 claims description 9
- 239000008101 lactose Substances 0.000 claims description 9
- 239000013543 active substance Substances 0.000 claims description 6
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- 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 description 2
- 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 claims description 2
- 238000004821 distillation Methods 0.000 claims description 2
- 238000009413 insulation Methods 0.000 claims description 2
- 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 claims description 2
- 239000011343 solid material Substances 0.000 claims description 2
- 150000001875 compounds Chemical class 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 description 42
- 229960003745 esmolol Drugs 0.000 description 37
- AQNDDEOPVVGCPG-UHFFFAOYSA-N esmolol Chemical compound COC(=O)CCC1=CC=C(OCC(O)CNC(C)C)C=C1 AQNDDEOPVVGCPG-UHFFFAOYSA-N 0.000 description 37
- 238000004519 manufacturing process Methods 0.000 description 29
- 238000005352 clarification Methods 0.000 description 27
- 238000012360 testing method Methods 0.000 description 27
- 239000003814 drug Substances 0.000 description 21
- 238000005516 engineering process Methods 0.000 description 19
- 238000009472 formulation Methods 0.000 description 16
- 239000000203 mixture Substances 0.000 description 16
- 238000007689 inspection Methods 0.000 description 15
- 230000005496 eutectics Effects 0.000 description 14
- 230000008014 freezing Effects 0.000 description 14
- 238000007710 freezing Methods 0.000 description 14
- 239000008141 laxative Substances 0.000 description 14
- 238000011068 loading method Methods 0.000 description 14
- 230000001543 purgative effect Effects 0.000 description 14
- 238000005057 refrigeration Methods 0.000 description 14
- 230000001105 regulatory effect Effects 0.000 description 14
- 230000002040 relaxant effect Effects 0.000 description 14
- 239000002904 solvent Substances 0.000 description 14
- 238000003756 stirring Methods 0.000 description 14
- 241000283973 Oryctolagus cuniculus Species 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- AQHHHDLHHXJYJD-UHFFFAOYSA-N propranolol Chemical compound C1=CC=C2C(OCC(O)CNC(C)C)=CC=CC2=C1 AQHHHDLHHXJYJD-UHFFFAOYSA-N 0.000 description 4
- 241000700199 Cavia porcellus Species 0.000 description 3
- 206010020772 Hypertension Diseases 0.000 description 3
- 238000004128 high performance liquid chromatography Methods 0.000 description 3
- 230000007794 irritation Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- 206010018910 Haemolysis Diseases 0.000 description 2
- 230000004520 agglutination Effects 0.000 description 2
- 230000003288 anthiarrhythmic effect Effects 0.000 description 2
- 239000003416 antiarrhythmic agent Substances 0.000 description 2
- 210000001992 atrioventricular node Anatomy 0.000 description 2
- 238000012550 audit Methods 0.000 description 2
- 102000012740 beta Adrenergic Receptors Human genes 0.000 description 2
- 108010079452 beta Adrenergic Receptors Proteins 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 210000003743 erythrocyte Anatomy 0.000 description 2
- 230000008588 hemolysis Effects 0.000 description 2
- 230000002949 hemolytic effect Effects 0.000 description 2
- 229960003712 propranolol Drugs 0.000 description 2
- 210000005241 right ventricle Anatomy 0.000 description 2
- 230000035945 sensitivity Effects 0.000 description 2
- 231100000041 toxicology testing Toxicity 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 description 1
- UCTWMZQNUQWSLP-VIFPVBQESA-N (R)-adrenaline Chemical compound CNC[C@H](O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-VIFPVBQESA-N 0.000 description 1
- 229930182837 (R)-adrenaline Natural products 0.000 description 1
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 206010003658 Atrial Fibrillation Diseases 0.000 description 1
- 206010003662 Atrial flutter Diseases 0.000 description 1
- 206010020565 Hyperaemia Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 102100028255 Renin Human genes 0.000 description 1
- 108090000783 Renin Proteins 0.000 description 1
- 208000007888 Sinus Tachycardia Diseases 0.000 description 1
- 206010042600 Supraventricular arrhythmias Diseases 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 230000036783 anaphylactic response Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 239000002876 beta blocker Substances 0.000 description 1
- 229940110331 bextra Drugs 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 229960005139 epinephrine Drugs 0.000 description 1
- KAQKFAOMNZTLHT-VVUHWYTRSA-N epoprostenol Chemical compound O1C(=CCCCC(O)=O)C[C@@H]2[C@@H](/C=C/[C@@H](O)CCCCC)[C@H](O)C[C@@H]21 KAQKFAOMNZTLHT-VVUHWYTRSA-N 0.000 description 1
- 229960001123 epoprostenol Drugs 0.000 description 1
- 230000000004 hemodynamic effect Effects 0.000 description 1
- 230000003118 histopathologic effect Effects 0.000 description 1
- 150000003840 hydrochlorides Chemical class 0.000 description 1
- 230000001631 hypertensive effect Effects 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000007928 intraperitoneal injection Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 210000005240 left ventricle Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 229960002237 metoprolol Drugs 0.000 description 1
- IUBSYMUCCVWXPE-UHFFFAOYSA-N metoprolol Chemical compound COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 IUBSYMUCCVWXPE-UHFFFAOYSA-N 0.000 description 1
- 229910052756 noble gas Inorganic materials 0.000 description 1
- 229960002748 norepinephrine Drugs 0.000 description 1
- SFLSHLFXELFNJZ-UHFFFAOYSA-N norepinephrine Natural products NCC(O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-UHFFFAOYSA-N 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 208000009146 rhinoscleroma Diseases 0.000 description 1
- 238000009781 safety test method Methods 0.000 description 1
- 210000001013 sinoatrial node Anatomy 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000002889 sympathetic effect Effects 0.000 description 1
- 230000035488 systolic blood pressure Effects 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- LNPDTQAFDNKSHK-UHFFFAOYSA-N valdecoxib Chemical compound CC=1ON=C(C=2C=CC=CC=2)C=1C1=CC=C(S(N)(=O)=O)C=C1 LNPDTQAFDNKSHK-UHFFFAOYSA-N 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
Claims (4)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2004100657861A CN1303987C (zh) | 2004-11-19 | 2004-11-19 | 注射用盐酸艾司洛尔冻干粉针剂及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2004100657861A CN1303987C (zh) | 2004-11-19 | 2004-11-19 | 注射用盐酸艾司洛尔冻干粉针剂及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1634002A true CN1634002A (zh) | 2005-07-06 |
CN1303987C CN1303987C (zh) | 2007-03-14 |
Family
ID=34846547
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2004100657861A Expired - Fee Related CN1303987C (zh) | 2004-11-19 | 2004-11-19 | 注射用盐酸艾司洛尔冻干粉针剂及其制备方法 |
Country Status (1)
Country | Link |
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CN (1) | CN1303987C (zh) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102232930A (zh) * | 2010-05-06 | 2011-11-09 | 南京海辰药业有限公司 | 盐酸兰地洛尔药物组合物及其制备方法 |
CN111848420A (zh) * | 2020-07-22 | 2020-10-30 | 杭州煌森生物科技有限公司 | 一种盐酸艾司洛尔的新晶型及制备方法 |
US11246842B2 (en) | 2014-12-18 | 2022-02-15 | Windgap Medical, Inc. | Method and compositions for dissolving or solubilizing therapeutic agents |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6310094B1 (en) * | 2001-01-12 | 2001-10-30 | Baxter International Inc. | Ready-to-use esmolol solution |
TWI277414B (en) * | 2001-01-12 | 2007-04-01 | Baxter Int | Esmolol formulation |
CN1215836C (zh) * | 2003-07-29 | 2005-08-24 | 吉林市卓怡康纳制药有限公司 | 注射用盐酸索他洛尔及其制备方法 |
-
2004
- 2004-11-19 CN CNB2004100657861A patent/CN1303987C/zh not_active Expired - Fee Related
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102232930A (zh) * | 2010-05-06 | 2011-11-09 | 南京海辰药业有限公司 | 盐酸兰地洛尔药物组合物及其制备方法 |
CN102232930B (zh) * | 2010-05-06 | 2013-03-27 | 南京海辰药业有限公司 | 盐酸兰地洛尔药物组合物及其制备方法 |
US11246842B2 (en) | 2014-12-18 | 2022-02-15 | Windgap Medical, Inc. | Method and compositions for dissolving or solubilizing therapeutic agents |
CN111848420A (zh) * | 2020-07-22 | 2020-10-30 | 杭州煌森生物科技有限公司 | 一种盐酸艾司洛尔的新晶型及制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CN1303987C (zh) | 2007-03-14 |
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Date | Code | Title | Description |
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C06 | Publication | ||
PB01 | Publication | ||
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C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
EE01 | Entry into force of recordation of patent licensing contract |
Assignee: JIANGSU AOSAIKANG PHARMACEUTICAL Co.,Ltd. Assignor: Chen Qingcai|Zhao Jun Contract fulfillment period: 2007.4.8 to 2024.11.18 Contract record no.: 2008320000673 Denomination of invention: Esmolol Hydrochloride freeze dried powder for injection and its preparation method Granted publication date: 20070314 License type: Exclusive license Record date: 20081009 |
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LIC | Patent licence contract for exploitation submitted for record |
Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2007.4.8 TO 2024.11.18; CHANGE OF CONTRACT Name of requester: JIANGSU AOSAIKANG PHARMACEUTICAL CO., LTD. Effective date: 20081009 |
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ASS | Succession or assignment of patent right |
Free format text: FORMER OWNER: ZHAO JUN Owner name: JIANGSU AOSAIKANG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: CHEN QINGCAI Effective date: 20110413 |
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Free format text: CORRECT: ADDRESS; FROM: 210029 NANJING AOKANG MEDICAL TECHNOLOGY CO., LTD., TOWER C, 20/F, HANZHONG NEW CITY, NO. 1, HANZHONGMEN STREET, NANJING CITY, JIANGSU PROVINCE TO: 211112 NO. 699, KEJIAN ROAD, JIANGNING SCIENCE PARK, NANJING CITY, JIANGSU PROVINCE |
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TR01 | Transfer of patent right |
Effective date of registration: 20110413 Address after: 211112 Jiangsu Province, Nanjing City, Jiangning Science Park Road No. 699 Patentee after: JIANGSU AOSAIKANG PHARMACEUTICAL Co.,Ltd. Address before: 210029, Jiangsu City, Hanzhoung province Nanjing Avenue 1, Hanzhoung metro, 20 floor, block C, Nanjing AOKANG Pharmaceutical Technology Co., Ltd. Co-patentee before: Zhao Jun Patentee before: Chen Qingcai |
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C56 | Change in the name or address of the patentee |
Owner name: JIANGSU AOSAIKANG PARHMACEUTICAL CO., LTD. Free format text: FORMER NAME: JIANGSU AOSAIKANG PHARMACEUTICAL CO., LTD. |
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CP01 | Change in the name or title of a patent holder |
Address after: 211112 Jiangsu Province, Nanjing City, Jiangning Science Park Road No. 699 Patentee after: JIANGSU AOSAIKANG PHARMACEUTICAL Co.,Ltd. Address before: 211112 Jiangsu Province, Nanjing City, Jiangning Science Park Road No. 699 Patentee before: JIANGSU AOSAIKANG PHARMACEUTICAL Co.,Ltd. |
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CP01 | Change in the name or title of a patent holder | ||
CP01 | Change in the name or title of a patent holder |
Address after: 211112 Kejian Road, Jiangning Science Park, Nanjing City, Jiangsu Province, 699 Patentee after: JIANGSU AOSAIKANG PHARMACEUTICAL Co.,Ltd. Address before: 211112 Kejian Road, Jiangning Science Park, Nanjing City, Jiangsu Province, 699 Patentee before: JIANGSU AOSAIKANG PHARMACEUTICAL Co.,Ltd. |
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CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20070314 Termination date: 20211119 |
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CF01 | Termination of patent right due to non-payment of annual fee |