CN100367961C - 盐酸替罗非班冻干粉针注射剂及其制备方法 - Google Patents
盐酸替罗非班冻干粉针注射剂及其制备方法 Download PDFInfo
- Publication number
- CN100367961C CN100367961C CNB2005100152950A CN200510015295A CN100367961C CN 100367961 C CN100367961 C CN 100367961C CN B2005100152950 A CNB2005100152950 A CN B2005100152950A CN 200510015295 A CN200510015295 A CN 200510015295A CN 100367961 C CN100367961 C CN 100367961C
- Authority
- CN
- China
- Prior art keywords
- dried powder
- tirofiban hydrochloride
- tirofiban
- lactose
- hydrochloride 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.)
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- HWAAPJPFZPHHBC-FGJQBABTSA-N tirofiban hydrochloride Chemical compound O.Cl.C1=CC(C[C@H](NS(=O)(=O)CCCC)C(O)=O)=CC=C1OCCCCC1CCNCC1 HWAAPJPFZPHHBC-FGJQBABTSA-N 0.000 title claims abstract description 46
- 229960004929 tirofiban hydrochloride Drugs 0.000 title claims abstract description 44
- 239000000843 powder Substances 0.000 title claims abstract description 30
- 238000000034 method Methods 0.000 title claims abstract description 24
- 239000000243 solution Substances 0.000 claims abstract description 50
- 229960003425 tirofiban Drugs 0.000 claims abstract description 35
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 28
- 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 abstract description 26
- 239000008101 lactose Substances 0.000 claims abstract description 26
- 238000002360 preparation method Methods 0.000 claims abstract description 24
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000008215 water for injection Substances 0.000 claims abstract description 20
- 238000001914 filtration Methods 0.000 claims abstract description 10
- 238000011049 filling Methods 0.000 claims abstract description 9
- 238000004108 freeze drying Methods 0.000 claims abstract description 9
- 238000003756 stirring Methods 0.000 claims description 17
- 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 8
- 238000005262 decarbonization Methods 0.000 claims description 8
- 239000012528 membrane Substances 0.000 claims description 8
- 238000012856 packing Methods 0.000 claims description 8
- 239000004033 plastic Substances 0.000 claims description 8
- 229910052799 carbon Inorganic materials 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- 239000002253 acid Substances 0.000 claims description 2
- 239000003513 alkali Substances 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 claims description 2
- 238000002347 injection Methods 0.000 abstract description 45
- 239000007924 injection Substances 0.000 abstract description 45
- 239000003814 drug Substances 0.000 abstract description 14
- 239000000126 substance Substances 0.000 abstract description 5
- 230000008901 benefit Effects 0.000 abstract description 4
- 230000015556 catabolic process Effects 0.000 abstract description 2
- 238000006731 degradation reaction Methods 0.000 abstract description 2
- 230000008569 process Effects 0.000 abstract description 2
- 230000001105 regulatory effect Effects 0.000 abstract description 2
- 238000003860 storage Methods 0.000 abstract description 2
- 229910052782 aluminium Inorganic materials 0.000 abstract 1
- 239000003242 anti bacterial agent Substances 0.000 abstract 1
- 230000003115 biocidal effect Effects 0.000 abstract 1
- 238000004806 packaging method and process Methods 0.000 abstract 1
- COKMIXFXJJXBQG-NRFANRHFSA-N tirofiban Chemical compound C1=CC(C[C@H](NS(=O)(=O)CCCC)C(O)=O)=CC=C1OCCCCC1CCNCC1 COKMIXFXJJXBQG-NRFANRHFSA-N 0.000 description 33
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 27
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 20
- 238000012360 testing method Methods 0.000 description 20
- 239000013618 particulate matter Substances 0.000 description 13
- 241000283973 Oryctolagus cuniculus Species 0.000 description 8
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 8
- 239000000047 product Substances 0.000 description 8
- 206010018910 Haemolysis Diseases 0.000 description 7
- 210000003743 erythrocyte Anatomy 0.000 description 7
- 230000008588 hemolysis Effects 0.000 description 7
- 230000033228 biological regulation Effects 0.000 description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 239000011265 semifinished product Substances 0.000 description 6
- 239000011780 sodium chloride Substances 0.000 description 6
- 210000003462 vein Anatomy 0.000 description 6
- 206010002198 Anaphylactic reaction Diseases 0.000 description 5
- 241000700199 Cavia porcellus Species 0.000 description 5
- 241001465754 Metazoa Species 0.000 description 5
- 230000036783 anaphylactic response Effects 0.000 description 5
- 208000003455 anaphylaxis Diseases 0.000 description 5
- 238000002474 experimental method Methods 0.000 description 5
- 238000007689 inspection Methods 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 210000004204 blood vessel Anatomy 0.000 description 4
- 230000037396 body weight Effects 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 230000034994 death Effects 0.000 description 4
- 238000001514 detection method Methods 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000012535 impurity Substances 0.000 description 4
- 235000011121 sodium hydroxide Nutrition 0.000 description 4
- 238000010998 test method Methods 0.000 description 4
- 108010058846 Ovalbumin Proteins 0.000 description 3
- 208000005392 Spasm Diseases 0.000 description 3
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical compound CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 description 3
- 238000010171 animal model Methods 0.000 description 3
- 230000002950 deficient Effects 0.000 description 3
- 230000002949 hemolytic effect Effects 0.000 description 3
- 238000010253 intravenous injection Methods 0.000 description 3
- 229940092253 ovalbumin Drugs 0.000 description 3
- 239000008354 sodium chloride injection Substances 0.000 description 3
- 230000000638 stimulation Effects 0.000 description 3
- 239000006228 supernatant Substances 0.000 description 3
- 206010011224 Cough Diseases 0.000 description 2
- 208000000059 Dyspnea Diseases 0.000 description 2
- 206010013975 Dyspnoeas Diseases 0.000 description 2
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 2
- 206010020751 Hypersensitivity Diseases 0.000 description 2
- 206010028851 Necrosis Diseases 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 206010044565 Tremor Diseases 0.000 description 2
- 238000004220 aggregation Methods 0.000 description 2
- 230000002776 aggregation Effects 0.000 description 2
- 230000000702 anti-platelet effect Effects 0.000 description 2
- 239000003146 anticoagulant agent Substances 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000001802 infusion Methods 0.000 description 2
- 239000004531 microgranule Substances 0.000 description 2
- 208000010125 myocardial infarction Diseases 0.000 description 2
- 230000017074 necrotic cell death Effects 0.000 description 2
- 230000035939 shock Effects 0.000 description 2
- 239000001509 sodium citrate Substances 0.000 description 2
- 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 description 2
- 239000007787 solid Substances 0.000 description 2
- 208000010110 spontaneous platelet aggregation Diseases 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 208000004476 Acute Coronary Syndrome Diseases 0.000 description 1
- 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 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- 102000008946 Fibrinogen Human genes 0.000 description 1
- 108010049003 Fibrinogen Proteins 0.000 description 1
- 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 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 241000283898 Ovis Species 0.000 description 1
- 108010035030 Platelet Membrane Glycoprotein IIb Proteins 0.000 description 1
- 206010070834 Sensitisation Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 208000007814 Unstable Angina Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- WEVYAHXRMPXWCK-UHFFFAOYSA-N acetonitrile Substances CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000000172 allergic effect Effects 0.000 description 1
- 238000002399 angioplasty Methods 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 125000000484 butyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 239000006285 cell suspension Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000003750 conditioning effect Effects 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
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- 239000012153 distilled water Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 229940012952 fibrinogen Drugs 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- DKAGJZJALZXOOV-UHFFFAOYSA-N hydrate;hydrochloride Chemical compound O.Cl DKAGJZJALZXOOV-UHFFFAOYSA-N 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000011534 incubation Methods 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 208000028867 ischemia Diseases 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 208000031225 myocardial ischemia Diseases 0.000 description 1
- 239000013642 negative control Substances 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 1
- 239000013641 positive control Substances 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 239000002464 receptor antagonist Substances 0.000 description 1
- 229940044551 receptor antagonist Drugs 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 230000000250 revascularization Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
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- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000011003 system suitability test Methods 0.000 description 1
- 229960004441 tyrosine Drugs 0.000 description 1
- 210000003556 vascular endothelial cell Anatomy 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
检查项目 | 样品1 | 样品2 | 样品3 | |||||||||
0天 | 10天 | 30天 | 60天 | 0天 | 10天 | 30天 | 60天 | 0天 | 10天 | 30天 | 60天 | |
含量(%) | 99.7 | 99.6 | 99.5 | 99.4 | 99.6 | 99.6 | 99.4 | 99.2 | 99.8 | 99.8 | 99.8 | 99.7 |
有关物质(%) | 0.14 | 0.15 | 0.17 | 0.21 | 0.13 | 0.16 | 0.18 | 0.22 | 0.14 | 0.13 | 0.14 | 0.15 |
可见异物 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 |
不溶性微粒 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 | 合格 |
反应级数 | 反应症状 |
0 | 无明显反应 |
1 | 只有轻微抓鼻、颤抖或竖毛 |
2 | 有几次咳嗽、有抓鼻、颤抖或竖毛 |
3 | 多次或连续咳嗽、伴有呼吸困难或痉挛、抽搐 |
4 | 痉挛、抽搐、大小便失禁、休克死亡 |
组别 | 动物数(只) | 过敏反应级数 | |
14天(n=3) | 21天(n=3) | ||
注射用盐酸替罗非班 | 6 | 0 | 0 |
0.9%氯化钠注射液 | 6 | 0 | 0 |
1%卵白蛋白 | 6 | 4 | 4 |
程度 | 标识 | 现象 |
无溶血 | - | 红细胞全部下沉,上清液体无色澄明 |
部分溶血 | ± | 溶液澄明红色或棕色,管底有少量红细胞残留 |
全溶血 | + | 溶液澄明红色,管底无红细胞残留 |
凝聚 | 溶液中有棕红色或红棕色絮状沉淀,振摇后不能分散 |
时间 | 试管号 | ||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | |
15min | - | - | - | - | - | - | + |
30min | - | - | - | - | - | - | + |
45min | - | - | - | - | - | - | + |
1h | - | - | - | - | - | - | + |
2hr | - | - | - | - | - | - | + |
3hr | + |
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2005100152950A CN100367961C (zh) | 2005-09-30 | 2005-09-30 | 盐酸替罗非班冻干粉针注射剂及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CNB2005100152950A CN100367961C (zh) | 2005-09-30 | 2005-09-30 | 盐酸替罗非班冻干粉针注射剂及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1742725A CN1742725A (zh) | 2006-03-08 |
CN100367961C true CN100367961C (zh) | 2008-02-13 |
Family
ID=36138351
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2005100152950A Active CN100367961C (zh) | 2005-09-30 | 2005-09-30 | 盐酸替罗非班冻干粉针注射剂及其制备方法 |
Country Status (1)
Country | Link |
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CN (1) | CN100367961C (zh) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101716148B (zh) * | 2009-12-08 | 2012-03-07 | 鲁南制药集团股份有限公司 | 一种盐酸替罗非班冻干粉针制剂及其制备方法 |
CN101756915B (zh) * | 2010-02-25 | 2011-06-22 | 山东新时代药业有限公司 | 盐酸替罗非班冻干粉针注射剂及制备方法 |
CN110988158A (zh) * | 2019-11-25 | 2020-04-10 | 鲁南制药集团股份有限公司 | 一种盐酸替罗非班注射液有关物质的检测方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1200676A (zh) * | 1995-10-27 | 1998-12-02 | 麦克公司 | 含有血小板凝集抑制剂的药物组合物 |
CN1446537A (zh) * | 2003-03-29 | 2003-10-08 | 王鹤东 | 甲磺酸二氢麦角碱冻干粉针及其制备方法 |
-
2005
- 2005-09-30 CN CNB2005100152950A patent/CN100367961C/zh active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1200676A (zh) * | 1995-10-27 | 1998-12-02 | 麦克公司 | 含有血小板凝集抑制剂的药物组合物 |
CN1446537A (zh) * | 2003-03-29 | 2003-10-08 | 王鹤东 | 甲磺酸二氢麦角碱冻干粉针及其制备方法 |
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