CN102166360B - 一种布洛芬静脉给药制剂及其制备方法 - Google Patents
一种布洛芬静脉给药制剂及其制备方法 Download PDFInfo
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- CN102166360B CN102166360B CN 201110041127 CN201110041127A CN102166360B CN 102166360 B CN102166360 B CN 102166360B CN 201110041127 CN201110041127 CN 201110041127 CN 201110041127 A CN201110041127 A CN 201110041127A CN 102166360 B CN102166360 B CN 102166360B
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- Prior art keywords
- ibuprofen
- injection
- sodium chloride
- minutes
- finished product
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- 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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- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 title claims abstract description 110
- 229960001680 ibuprofen Drugs 0.000 title claims abstract description 98
- 238000002360 preparation method Methods 0.000 title claims abstract description 43
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 79
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 43
- 239000008215 water for injection Substances 0.000 claims abstract description 36
- 230000001954 sterilising effect Effects 0.000 claims description 72
- 239000011780 sodium chloride Substances 0.000 claims description 38
- 238000003756 stirring Methods 0.000 claims description 37
- 239000011265 semifinished product Substances 0.000 claims description 32
- 239000000047 product Substances 0.000 claims description 30
- 238000004659 sterilization and disinfection Methods 0.000 claims description 23
- 238000012856 packing Methods 0.000 claims description 20
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 18
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims description 17
- 229930064664 L-arginine Natural products 0.000 claims description 17
- 235000014852 L-arginine Nutrition 0.000 claims description 17
- 230000033228 biological regulation Effects 0.000 claims description 17
- 239000003610 charcoal Substances 0.000 claims description 17
- 238000005070 sampling Methods 0.000 claims description 17
- 238000001914 filtration Methods 0.000 claims description 16
- 238000007689 inspection Methods 0.000 claims description 16
- 230000001186 cumulative effect Effects 0.000 claims description 15
- 230000002950 deficient Effects 0.000 claims description 15
- 238000011049 filling Methods 0.000 claims description 15
- 238000007731 hot pressing Methods 0.000 claims description 15
- 229940105082 medicinal charcoal Drugs 0.000 claims description 15
- 239000011824 nuclear material Substances 0.000 claims description 15
- 239000002994 raw material Substances 0.000 claims description 15
- 239000004475 Arginine Substances 0.000 claims description 13
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 13
- 235000009697 arginine Nutrition 0.000 claims description 13
- 210000003462 vein Anatomy 0.000 claims description 12
- 238000012377 drug delivery Methods 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 9
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 7
- 238000009472 formulation Methods 0.000 claims description 6
- 239000008354 sodium chloride injection Substances 0.000 abstract description 40
- 239000007924 injection Substances 0.000 abstract description 12
- 238000002347 injection Methods 0.000 abstract description 12
- 239000003513 alkali Substances 0.000 abstract description 11
- 230000001105 regulatory effect Effects 0.000 abstract description 4
- 239000000243 solution Substances 0.000 description 31
- 230000003204 osmotic effect Effects 0.000 description 21
- 238000012360 testing method Methods 0.000 description 20
- 150000002576 ketones Chemical class 0.000 description 14
- 229940083243 caldolor Drugs 0.000 description 11
- 229940090044 injection Drugs 0.000 description 11
- 229940088523 ibuprofen injection Drugs 0.000 description 10
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 9
- 238000001990 intravenous administration Methods 0.000 description 8
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 6
- 241000283973 Oryctolagus cuniculus Species 0.000 description 6
- 238000001514 detection method Methods 0.000 description 6
- HEFNNWSXXWATRW-JTQLQIEISA-N dexibuprofen Chemical compound CC(C)CC1=CC=C([C@H](C)C(O)=O)C=C1 HEFNNWSXXWATRW-JTQLQIEISA-N 0.000 description 6
- 238000010790 dilution Methods 0.000 description 6
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- 239000002552 dosage form Substances 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 239000012535 impurity Substances 0.000 description 5
- 230000008859 change Effects 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000008103 glucose Substances 0.000 description 4
- 239000003960 organic solvent Substances 0.000 description 4
- NOEGNKMFWQHSLB-UHFFFAOYSA-N 5-hydroxymethylfurfural Chemical compound OCC1=CC=C(C=O)O1 NOEGNKMFWQHSLB-UHFFFAOYSA-N 0.000 description 3
- 206010018910 Haemolysis Diseases 0.000 description 3
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 3
- 239000004472 Lysine Substances 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- GZVNVLXPXXNRBU-XRIOVQLTSA-M [Cl-].[Na+].OC(=O)[C@@H](C)C1=CC=C(CC(C)C)C=C1 Chemical compound [Cl-].[Na+].OC(=O)[C@@H](C)C1=CC=C(CC(C)C)C=C1 GZVNVLXPXXNRBU-XRIOVQLTSA-M 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 3
- 239000003085 diluting agent Substances 0.000 description 3
- 230000008588 hemolysis Effects 0.000 description 3
- 230000002949 hemolytic effect Effects 0.000 description 3
- RJGBSYZFOCAGQY-UHFFFAOYSA-N hydroxymethylfurfural Natural products COC1=CC=C(C=O)O1 RJGBSYZFOCAGQY-UHFFFAOYSA-N 0.000 description 3
- 230000007794 irritation Effects 0.000 description 3
- 150000007530 organic bases Chemical class 0.000 description 3
- 230000036407 pain Effects 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 235000011121 sodium hydroxide Nutrition 0.000 description 3
- 238000013112 stability test Methods 0.000 description 3
- 230000000638 stimulation Effects 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 2
- ODKSFYDXXFIFQN-SCSAIBSYSA-N D-arginine Chemical compound OC(=O)[C@H](N)CCCNC(N)=N ODKSFYDXXFIFQN-SCSAIBSYSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 2
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 2
- 229960001138 acetylsalicylic acid Drugs 0.000 description 2
- 230000036592 analgesia Effects 0.000 description 2
- 239000006285 cell suspension Substances 0.000 description 2
- 238000005352 clarification Methods 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000002158 endotoxin Substances 0.000 description 2
- 229940093181 glucose injection Drugs 0.000 description 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 2
- 238000001802 infusion Methods 0.000 description 2
- 150000007529 inorganic bases Chemical class 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 239000013618 particulate matter Substances 0.000 description 2
- BWHMMNNQKKPAPP-UHFFFAOYSA-L potassium carbonate Chemical compound [K+].[K+].[O-]C([O-])=O BWHMMNNQKKPAPP-UHFFFAOYSA-L 0.000 description 2
- 238000004088 simulation Methods 0.000 description 2
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 description 2
- 239000003381 stabilizer Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- 206010003694 Atrophy Diseases 0.000 description 1
- 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 description 1
- 206010015150 Erythema Diseases 0.000 description 1
- 102000008946 Fibrinogen Human genes 0.000 description 1
- 108010049003 Fibrinogen Proteins 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 1
- ABBQHOQBGMUPJH-UHFFFAOYSA-M Sodium salicylate Chemical compound [Na+].OC1=CC=CC=C1C([O-])=O ABBQHOQBGMUPJH-UHFFFAOYSA-M 0.000 description 1
- 241000294142 Vascellum Species 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 239000003470 adrenal cortex hormone Substances 0.000 description 1
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- 230000003110 anti-inflammatory effect Effects 0.000 description 1
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- 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 description 1
- 238000010241 blood sampling Methods 0.000 description 1
- BPKIGYQJPYCAOW-FFJTTWKXSA-I calcium;potassium;disodium;(2s)-2-hydroxypropanoate;dichloride;dihydroxide;hydrate Chemical compound O.[OH-].[OH-].[Na+].[Na+].[Cl-].[Cl-].[K+].[Ca+2].C[C@H](O)C([O-])=O BPKIGYQJPYCAOW-FFJTTWKXSA-I 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000005660 chlorination reaction Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 210000005069 ears Anatomy 0.000 description 1
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- 229940012952 fibrinogen Drugs 0.000 description 1
- 239000003862 glucocorticoid Substances 0.000 description 1
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- 235000014304 histidine Nutrition 0.000 description 1
- CYWFCPPBTWOZSF-UHFFFAOYSA-N ibufenac Chemical compound CC(C)CC1=CC=C(CC(O)=O)C=C1 CYWFCPPBTWOZSF-UHFFFAOYSA-N 0.000 description 1
- 229950009183 ibufenac Drugs 0.000 description 1
- 229940082159 ibuprofen 300 mg Drugs 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
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- HFHZKZSRXITVMK-UHFFFAOYSA-N oxyphenbutazone Chemical compound O=C1C(CCCC)C(=O)N(C=2C=CC=CC=2)N1C1=CC=C(O)C=C1 HFHZKZSRXITVMK-UHFFFAOYSA-N 0.000 description 1
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- VYMDGNCVAMGZFE-UHFFFAOYSA-N phenylbutazonum Chemical compound O=C1C(CCCC)C(=O)N(C=2C=CC=CC=2)N1C1=CC=CC=C1 VYMDGNCVAMGZFE-UHFFFAOYSA-N 0.000 description 1
- 208000001297 phlebitis Diseases 0.000 description 1
- 239000011736 potassium bicarbonate Substances 0.000 description 1
- 235000015497 potassium bicarbonate Nutrition 0.000 description 1
- 229910000028 potassium bicarbonate Inorganic materials 0.000 description 1
- 229910000027 potassium carbonate Inorganic materials 0.000 description 1
- 235000011181 potassium carbonates Nutrition 0.000 description 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 description 1
- 235000011118 potassium hydroxide Nutrition 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
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- 238000005057 refrigeration Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 235000017550 sodium carbonate Nutrition 0.000 description 1
- 229960004025 sodium salicylate Drugs 0.000 description 1
- 235000010265 sodium sulphite Nutrition 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- RQAITHJHUFFEIV-UHFFFAOYSA-N thurfyl nicotinate Chemical compound C=1C=CN=CC=1C(=O)OCC1CCCO1 RQAITHJHUFFEIV-UHFFFAOYSA-N 0.000 description 1
- 229950006036 thurfyl nicotinate Drugs 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
编号 | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
2%红细胞悬液ml | 2.5 | 2.5 | 2.5 | 2.5 | 2.5 | 2.5 | 2.5 |
氯化钠注射液ml | / | 0.5 | 1.0 | 1.5 | 2.0 | 2.5 | / |
布洛芬氯化钠注射液ml | 2.5 | 2.0 | 1.5 | 1.0 | 0.5 | / | / |
蒸馏水 | / | / | / | / | / | / | 2.5 |
15min | - | - | - | - | - | - | + |
30min | - | - | - | - | - | - | + |
45min | - | - | - | - | - | - | + |
1h | - | - | - | - | - | - | + |
2h | - | - | - | - | - | - | + |
3h | - | - | - | - | - | - | + |
Claims (1)
Priority Applications (1)
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CN 201110041127 CN102166360B (zh) | 2010-03-22 | 2011-02-21 | 一种布洛芬静脉给药制剂及其制备方法 |
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CN201010130061A CN101785754A (zh) | 2010-03-22 | 2010-03-22 | 一种布洛芬静脉给药制剂及其制备方法 |
CN201010130061.1 | 2010-03-22 | ||
CN 201110041127 CN102166360B (zh) | 2010-03-22 | 2011-02-21 | 一种布洛芬静脉给药制剂及其制备方法 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
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CN2012103495030A Division CN102895220A (zh) | 2011-02-21 | 2011-02-21 | 一种酮基布洛芬静脉给药制剂及其制备方法 |
CN2012103495168A Division CN102871957A (zh) | 2011-02-21 | 2011-02-21 | 一种右布洛芬静脉给药制剂及其制备方法 |
Publications (2)
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CN102166360A CN102166360A (zh) | 2011-08-31 |
CN102166360B true CN102166360B (zh) | 2013-04-10 |
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CN201010130061A Pending CN101785754A (zh) | 2010-03-22 | 2010-03-22 | 一种布洛芬静脉给药制剂及其制备方法 |
CN 201110041127 Ceased CN102166360B (zh) | 2010-03-22 | 2011-02-21 | 一种布洛芬静脉给药制剂及其制备方法 |
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Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101785754A (zh) * | 2010-03-22 | 2010-07-28 | 陕西合成药业有限公司 | 一种布洛芬静脉给药制剂及其制备方法 |
CN102552117B (zh) * | 2010-12-27 | 2014-07-09 | 成都天台山制药有限公司 | 一种含有布洛芬的注射剂及其制备方法 |
CN102871957A (zh) * | 2011-02-21 | 2013-01-16 | 陕西合成药业有限公司 | 一种右布洛芬静脉给药制剂及其制备方法 |
CN102895220A (zh) * | 2011-02-21 | 2013-01-30 | 陕西合成药业有限公司 | 一种酮基布洛芬静脉给药制剂及其制备方法 |
CN102138893A (zh) * | 2011-03-21 | 2011-08-03 | 陕西宏府怡悦制药有限公司 | 制备赖氨洛芬氯化钠注射液的工艺方法及其用途 |
CN102362857A (zh) * | 2011-11-22 | 2012-02-29 | 陆荣政 | 一种右旋布洛芬注射液及其制备方法 |
CN102716108A (zh) * | 2012-06-01 | 2012-10-10 | 陕西合成药业有限公司 | 一种布洛芬精氨酸氯化钠注射液及其制备方法和用途 |
CN103505447A (zh) * | 2012-06-21 | 2014-01-15 | 哈尔滨誉衡药业股份有限公司 | 一种含有布洛芬的药物组合物及其用途 |
CN103565733A (zh) * | 2012-07-31 | 2014-02-12 | 南京帝易医药科技有限公司 | 一种pH为6.0-6.5的布洛芬氯化钠注射液制剂及其制备方法 |
CN104622816B (zh) * | 2015-01-04 | 2017-05-10 | 济南东方开元医药新技术有限公司 | 一种布洛芬冻干粉针组合物及制备方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101077344A (zh) * | 2006-12-25 | 2007-11-28 | 汪洪湖 | 布洛芬输液制剂及其制备方法 |
CN101785754A (zh) * | 2010-03-22 | 2010-07-28 | 陕西合成药业有限公司 | 一种布洛芬静脉给药制剂及其制备方法 |
-
2010
- 2010-03-22 CN CN201010130061A patent/CN101785754A/zh active Pending
-
2011
- 2011-02-21 CN CN 201110041127 patent/CN102166360B/zh not_active Ceased
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101077344A (zh) * | 2006-12-25 | 2007-11-28 | 汪洪湖 | 布洛芬输液制剂及其制备方法 |
CN101785754A (zh) * | 2010-03-22 | 2010-07-28 | 陕西合成药业有限公司 | 一种布洛芬静脉给药制剂及其制备方法 |
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CN101785754A (zh) | 2010-07-28 |
CN102166360A (zh) | 2011-08-31 |
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