CN100366250C - 长春西汀冻干粉针制剂及其制备工艺 - Google Patents
长春西汀冻干粉针制剂及其制备工艺 Download PDFInfo
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- CN100366250C CN100366250C CNB2004100464197A CN200410046419A CN100366250C CN 100366250 C CN100366250 C CN 100366250C CN B2004100464197 A CNB2004100464197 A CN B2004100464197A CN 200410046419 A CN200410046419 A CN 200410046419A CN 100366250 C CN100366250 C CN 100366250C
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- Prior art keywords
- vinpocetine
- weight portion
- lyophilized injectable
- injection
- frozen
- 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.)
- Expired - Lifetime
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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 76
- 229960000744 vinpocetine Drugs 0.000 title claims abstract description 75
- 239000000843 powder Substances 0.000 title claims abstract description 37
- 238000002347 injection Methods 0.000 title claims abstract description 32
- 239000007924 injection Substances 0.000 title claims abstract description 32
- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- 239000000243 solution Substances 0.000 claims description 35
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 27
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 25
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid group Chemical group C(CC(O)(C(=O)O)CC(=O)O)(=O)O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 24
- 238000004108 freeze drying Methods 0.000 claims description 23
- 239000007788 liquid Substances 0.000 claims description 21
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 19
- 229930195725 Mannitol Natural products 0.000 claims description 19
- 239000000594 mannitol Substances 0.000 claims description 19
- 235000010355 mannitol Nutrition 0.000 claims description 19
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 17
- 239000003795 chemical substances by application Substances 0.000 claims description 17
- 238000003756 stirring Methods 0.000 claims description 17
- 239000008215 water for injection Substances 0.000 claims description 16
- 239000006184 cosolvent Substances 0.000 claims description 13
- 239000000126 substance Substances 0.000 claims description 12
- 210000004907 gland Anatomy 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 11
- 239000003963 antioxidant agent Substances 0.000 claims description 10
- 230000003078 antioxidant effect Effects 0.000 claims description 10
- 229910052799 carbon Inorganic materials 0.000 claims description 10
- 230000008859 change Effects 0.000 claims description 10
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- 238000002372 labelling Methods 0.000 claims description 9
- 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 claims description 8
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 8
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims description 8
- 238000005303 weighing Methods 0.000 claims description 8
- 230000014759 maintenance of location Effects 0.000 claims description 7
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 6
- 229920002307 Dextran Polymers 0.000 claims description 6
- 238000003556 assay Methods 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 6
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 6
- 235000010199 sorbic acid Nutrition 0.000 claims description 6
- 239000004334 sorbic acid Substances 0.000 claims description 6
- 229940075582 sorbic acid Drugs 0.000 claims description 6
- 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 5
- 239000008103 glucose Substances 0.000 claims description 5
- 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 4
- 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 4
- 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 description 4
- 239000002158 endotoxin Substances 0.000 claims description 4
- 238000002474 experimental method Methods 0.000 claims description 4
- 238000004128 high performance liquid chromatography Methods 0.000 claims description 4
- 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 4
- 239000004310 lactic acid Substances 0.000 claims description 4
- 235000014655 lactic acid Nutrition 0.000 claims description 4
- 239000013558 reference substance Substances 0.000 claims description 4
- 235000010265 sodium sulphite Nutrition 0.000 claims description 4
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 claims description 4
- 235000019345 sodium thiosulphate Nutrition 0.000 claims description 4
- 239000000600 sorbitol Substances 0.000 claims description 4
- 239000011975 tartaric acid Substances 0.000 claims description 4
- 235000002906 tartaric acid Nutrition 0.000 claims description 4
- 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 3
- 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 3
- ONBIUAZBGHXJDM-UHFFFAOYSA-J bismuth;potassium;tetraiodide Chemical compound [K+].[I-].[I-].[I-].[I-].[Bi+3] ONBIUAZBGHXJDM-UHFFFAOYSA-J 0.000 claims description 3
- 239000008101 lactose Substances 0.000 claims description 3
- 238000001556 precipitation Methods 0.000 claims description 3
- 230000004580 weight loss Effects 0.000 claims description 3
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- 235000011054 acetic acid Nutrition 0.000 claims description 2
- 239000007864 aqueous solution Substances 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
- 235000015165 citric acid Nutrition 0.000 claims description 2
- 239000008176 lyophilized powder Substances 0.000 claims description 2
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims description 2
- 235000010262 sodium metabisulphite Nutrition 0.000 claims description 2
- 238000012859 sterile filling Methods 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 238000003908 quality control method Methods 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 claims 1
- -1 wherein Substances 0.000 claims 1
- 239000002904 solvent Substances 0.000 abstract 1
- 239000000047 product Substances 0.000 description 38
- 229940090044 injection Drugs 0.000 description 28
- 238000012360 testing method Methods 0.000 description 20
- 238000001914 filtration Methods 0.000 description 14
- 238000005352 clarification Methods 0.000 description 13
- 238000005516 engineering process Methods 0.000 description 13
- 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 description 9
- 229920005549 butyl rubber Polymers 0.000 description 7
- 239000003610 charcoal Substances 0.000 description 7
- 239000000706 filtrate Substances 0.000 description 7
- 239000012982 microporous membrane Substances 0.000 description 7
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 238000007493 shaping process Methods 0.000 description 4
- 208000006011 Stroke Diseases 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 3
- 230000036770 blood supply Effects 0.000 description 3
- 210000004556 brain Anatomy 0.000 description 3
- 230000002490 cerebral effect Effects 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- 238000000528 statistical test Methods 0.000 description 3
- 206010065559 Cerebral arteriosclerosis Diseases 0.000 description 2
- 206010008190 Cerebrovascular accident Diseases 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 230000001684 chronic effect Effects 0.000 description 2
- 208000029078 coronary artery disease Diseases 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000008273 gelatin Substances 0.000 description 2
- 229920000159 gelatin Polymers 0.000 description 2
- 235000019322 gelatine Nutrition 0.000 description 2
- 235000011852 gelatine desserts Nutrition 0.000 description 2
- 239000000413 hydrolysate Substances 0.000 description 2
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- 150000002475 indoles Chemical class 0.000 description 2
- 201000005851 intracranial arteriosclerosis Diseases 0.000 description 2
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- 201000006474 Brain Ischemia Diseases 0.000 description 1
- 206010008111 Cerebral haemorrhage Diseases 0.000 description 1
- 206010008120 Cerebral ischaemia Diseases 0.000 description 1
- 206010057315 Daydreaming Diseases 0.000 description 1
- 206010012289 Dementia Diseases 0.000 description 1
- XEUCQOBUZPQUMQ-UHFFFAOYSA-N Glycolone Chemical compound COC1=C(CC=C(C)C)C(=O)NC2=C1C=CC=C2OC XEUCQOBUZPQUMQ-UHFFFAOYSA-N 0.000 description 1
- UWIULCYKVGIOPW-UHFFFAOYSA-N Glycolone Natural products CCOC1=C(CC=CC)C(=O)N(C)c2c(O)cccc12 UWIULCYKVGIOPW-UHFFFAOYSA-N 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 208000031226 Hyperlipidaemia Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 206010022998 Irritability Diseases 0.000 description 1
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- 230000033228 biological regulation Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
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- 230000008499 blood brain barrier function Effects 0.000 description 1
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- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
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- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
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- 201000010875 transient cerebral ischemia Diseases 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
加入甘露醇量(g/ml) | 冻干样品外观 | 复水性 | 标示量(%) | |
l234567 | 3%5%8%10%12%15%18% | 萎缩,易碎可成型,用力振荡易碎成形好,细密不易碎成形好,细密不易碎成形好,细密不易碎成形好,细密不易碎溶液饱和,略有不溶物 | -好好好好好好 | -100.3899.93100.9199.4699.52100.01 |
留样 | 性状 | 酸度 | 溶液的颜色和澄清度 | 有关物质(%) | 含量(%) |
0月 | 白色疏松块状物 | 3.4 | 无色、澄清 | 0.81 | 100.8 |
3月 | 白色疏松块状物 | 3.4 | 无色、澄清 | 0.8l | 100.6 |
6月 | 白色疏松块状物 | 3.5 | 无色、澄清 | 0.80 | 100.5 |
9月 | 白色疏松块状物 | 3.4 | 无色、澄清 | 0.82 | 100.9 |
12月 | 白色疏松块状物 | 3.5 | 无色、澄清 | 0.81 | 100.8 |
18月 | 白色疏松块状物 | 3.5 | 无色、澄清 | 0.83 | 100.6 |
24月 | 白色疏松块状物 | 3.5 | 无色、澄清 | 0.85 | 100.7 |
留样 | 性状 | 酸度 | 溶液的颜色和澄清度 | 有关物质(%) | 含量(%) |
0月 | 无色澄明液体 | 3.5 | 无色、澄清 | 0.82 | 101.2 |
3月 | 无色澄明液体 | 3.5 | 无色、澄清 | 0.80 | 100.5 |
6月 | 无色澄明液体 | 3.6 | 无色、澄清 | 0.91 | 99.7 |
9月 | 无色澄明液体 | 3.5 | 无色、澄清 | 0.88 | 99.1 |
12月 | 无色澄明液体 | 3.7 | 无色、澄清 | 0.90 | 98.5 |
18月 | 无色澄明液体 | 3.9 | 无色、澄清 | 0.98 | 97.2 |
24月 | 无色澄明液体 | 4.5 | 微黄,略有不溶物 | 1.50 | 90.2 |
Claims (12)
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CNB2004100464197A CN100366250C (zh) | 2003-06-11 | 2004-06-09 | 长春西汀冻干粉针制剂及其制备工艺 |
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CN03137517.0 | 2003-06-11 | ||
CN03137517 | 2003-06-11 | ||
CNB2004100464197A CN100366250C (zh) | 2003-06-11 | 2004-06-09 | 长春西汀冻干粉针制剂及其制备工艺 |
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CN1572296A CN1572296A (zh) | 2005-02-02 |
CN100366250C true CN100366250C (zh) | 2008-02-06 |
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Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101264064B (zh) * | 2008-04-17 | 2011-04-20 | 孙向阳 | 一种长春西汀冻干粉针剂及其制备方法 |
CN101874776B (zh) * | 2009-04-28 | 2012-06-13 | 中国人民解放军军事医学科学院毒物药物研究所 | 长春西汀的干乳剂及其制备方法 |
CN102038680B (zh) * | 2010-11-24 | 2015-03-25 | 常建晖 | 一种药用组合物 |
CN102526042B (zh) * | 2010-12-09 | 2013-12-11 | 常建晖 | 稳定的液体药物组合物 |
CN102266329B (zh) * | 2011-06-16 | 2012-08-22 | 罗诚 | 一种含长春西汀化合物的药物组合物及其制备方法 |
CN102600143B (zh) * | 2012-02-24 | 2013-09-11 | 湖北美林药业有限公司 | 长春西汀药物组合物及其制备方法 |
CN102657646B (zh) * | 2012-05-14 | 2013-07-03 | 长春海悦药业有限公司 | 一种药物组合物及其制剂 |
CN105213323A (zh) * | 2014-05-30 | 2016-01-06 | 海南通用康力制药有限公司 | 一种注射用长春西汀冻干粉的制备方法 |
CN105267160B (zh) * | 2015-11-24 | 2019-05-14 | 河北智同生物制药股份有限公司 | 一种注射用长春西汀冻干制剂组合物及其制备方法 |
CN109364021A (zh) * | 2018-10-26 | 2019-02-22 | 山西普德药业有限公司 | 一种注射用长春西汀 |
-
2004
- 2004-06-09 CN CNB2004100464197A patent/CN100366250C/zh not_active Expired - Lifetime
Non-Patent Citations (1)
Title |
---|
长春西汀治疗急性脑梗死50例. 张杰文等.医药导报,第22卷第2期. 2003 * |
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