CN104586755B - 一种枸橼酸咖啡因注射液药物组合物及其制备方法 - Google Patents
一种枸橼酸咖啡因注射液药物组合物及其制备方法 Download PDFInfo
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- CN104586755B CN104586755B CN201410840801.9A CN201410840801A CN104586755B CN 104586755 B CN104586755 B CN 104586755B CN 201410840801 A CN201410840801 A CN 201410840801A CN 104586755 B CN104586755 B CN 104586755B
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- Prior art keywords
- injection
- caffeine
- sodium citrate
- water
- pharmaceutical composition
- Prior art date
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- RCQXSQPPHJPGOF-UHFFFAOYSA-N caffeine citrate Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O.CN1C(=O)N(C)C(=O)C2=C1N=CN2C RCQXSQPPHJPGOF-UHFFFAOYSA-N 0.000 title claims abstract description 40
- 229960002031 caffeine citrate Drugs 0.000 title claims abstract description 40
- 238000002347 injection Methods 0.000 title claims abstract description 34
- 239000007924 injection Substances 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 17
- 230000001954 sterilising effect Effects 0.000 claims abstract description 53
- 239000007788 liquid Substances 0.000 claims abstract description 27
- 238000000034 method Methods 0.000 claims abstract description 16
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 81
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 claims description 64
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 48
- 239000001509 sodium citrate Substances 0.000 claims description 39
- 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 description 39
- 239000008215 water for injection Substances 0.000 claims description 39
- LPHGQDQBBGAPDZ-UHFFFAOYSA-N Isocaffeine Natural products CN1C(=O)N(C)C(=O)C2=C1N(C)C=N2 LPHGQDQBBGAPDZ-UHFFFAOYSA-N 0.000 claims description 32
- 229960001948 caffeine Drugs 0.000 claims description 32
- VJEONQKOZGKCAK-UHFFFAOYSA-N caffeine Natural products CN1C(=O)N(C)C(=O)C2=C1C=CN2C VJEONQKOZGKCAK-UHFFFAOYSA-N 0.000 claims description 32
- 238000003756 stirring Methods 0.000 claims description 23
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 20
- 229920006393 polyether sulfone Polymers 0.000 claims description 19
- 238000001914 filtration Methods 0.000 claims description 16
- -1 wherein Substances 0.000 claims description 16
- 239000002253 acid Substances 0.000 claims description 15
- 239000003708 ampul Substances 0.000 claims description 11
- 239000004743 Polypropylene Substances 0.000 claims description 10
- 239000005388 borosilicate glass Substances 0.000 claims description 10
- 229920001155 polypropylene Polymers 0.000 claims description 10
- 240000004307 Citrus medica Species 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 9
- 239000004695 Polyether sulfone Substances 0.000 claims description 3
- 229910052799 carbon Inorganic materials 0.000 claims description 2
- 238000005262 decarbonization Methods 0.000 claims description 2
- 239000000126 substance Substances 0.000 abstract description 18
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 12
- 230000000694 effects Effects 0.000 abstract description 5
- 230000036512 infertility Effects 0.000 abstract description 4
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 230000004888 barrier function Effects 0.000 abstract description 3
- 239000007853 buffer solution Substances 0.000 abstract description 3
- XPFJYKARVSSRHE-UHFFFAOYSA-K trisodium;2-hydroxypropane-1,2,3-tricarboxylate;2-hydroxypropane-1,2,3-tricarboxylic acid Chemical compound [Na+].[Na+].[Na+].OC(=O)CC(O)(C(O)=O)CC(O)=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O XPFJYKARVSSRHE-UHFFFAOYSA-K 0.000 abstract description 3
- 238000012360 testing method Methods 0.000 description 22
- 239000000523 sample Substances 0.000 description 13
- 230000008859 change Effects 0.000 description 9
- 238000007689 inspection Methods 0.000 description 9
- 230000000052 comparative effect Effects 0.000 description 8
- 239000003814 drug Substances 0.000 description 8
- 235000002710 Ilex cornuta Nutrition 0.000 description 6
- 241001310146 Ilex cornuta Species 0.000 description 6
- 235000010326 Osmanthus heterophyllus Nutrition 0.000 description 6
- 238000010521 absorption reaction Methods 0.000 description 6
- 238000005070 sampling Methods 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 229940079593 drug Drugs 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 208000020112 Apnea of prematurity Diseases 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 3
- 238000011282 treatment Methods 0.000 description 3
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000010534 mechanism of action Effects 0.000 description 2
- 239000012488 sample solution Substances 0.000 description 2
- XFDJYSQDBULQSI-QFIPXVFZSA-N (R)-doxapram Chemical compound C([C@H]1CN(C(C1(C=1C=CC=CC=1)C=1C=CC=CC=1)=O)CC)CN1CCOCC1 XFDJYSQDBULQSI-QFIPXVFZSA-N 0.000 description 1
- RTAPDZBZLSXHQQ-UHFFFAOYSA-N 8-methyl-3,7-dihydropurine-2,6-dione Chemical class N1C(=O)NC(=O)C2=C1N=C(C)N2 RTAPDZBZLSXHQQ-UHFFFAOYSA-N 0.000 description 1
- 206010003497 Asphyxia Diseases 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
- 229960003556 aminophylline Drugs 0.000 description 1
- FQPFAHBPWDRTLU-UHFFFAOYSA-N aminophylline Chemical compound NCCN.O=C1N(C)C(=O)N(C)C2=C1NC=N2.O=C1N(C)C(=O)N(C)C2=C1NC=N2 FQPFAHBPWDRTLU-UHFFFAOYSA-N 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000011284 combination treatment Methods 0.000 description 1
- 229960002955 doxapram Drugs 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- RTZKZFJDLAIYFH-UHFFFAOYSA-N ether Substances CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 150000002576 ketones Chemical class 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- UZHSEJADLWPNLE-GRGSLBFTSA-N naloxone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C UZHSEJADLWPNLE-GRGSLBFTSA-N 0.000 description 1
- 229960004127 naloxone Drugs 0.000 description 1
- 239000002859 orphan drug Substances 0.000 description 1
- 229940000673 orphan drug Drugs 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 210000001034 respiratory center Anatomy 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 238000010025 steaming Methods 0.000 description 1
- ZFXYFBGIUFBOJW-UHFFFAOYSA-N theophylline Chemical class O=C1N(C)C(=O)N(C)C2=C1NC=N2 ZFXYFBGIUFBOJW-UHFFFAOYSA-N 0.000 description 1
Abstract
Description
Claims (6)
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CN201410840801.9A CN104586755B (zh) | 2014-12-30 | 2014-12-30 | 一种枸橼酸咖啡因注射液药物组合物及其制备方法 |
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CN201410840801.9A CN104586755B (zh) | 2014-12-30 | 2014-12-30 | 一种枸橼酸咖啡因注射液药物组合物及其制备方法 |
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CN104586755B true CN104586755B (zh) | 2016-11-30 |
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Families Citing this family (4)
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CN105250227A (zh) * | 2015-09-30 | 2016-01-20 | 合肥华方医药科技有限公司 | 一种枸橼酸咖啡因冻干粉及其制备方法 |
CN106137953A (zh) * | 2016-08-01 | 2016-11-23 | 嘉实(湖南)医药科技有限公司 | 蔗糖铁注射液及其制备方法 |
CN106420599B (zh) * | 2016-08-30 | 2020-01-17 | 安徽恒星制药有限公司 | 一种枸橼酸咖啡因注射液的制备方法 |
CN107233306A (zh) * | 2017-07-03 | 2017-10-10 | 华润双鹤利民药业(济南)有限公司 | 一种枸橼酸咖啡因注射液及其制备方法 |
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Address after: 611731 Chengdu province high tech Zone, west of the source road, No. 8, No. Applicant after: CHENGDU EASTON BIOPHARMACEUTICALS CO., LTD. Address before: 611731 Chengdu province high tech Zone, west of the source road, No. 8, No. Applicant before: Chengdu Easton Pharmaceutical Co., Ltd. |
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GR01 | Patent grant | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Caffeine citrate injection pharmaceutical composition and preparation method thereof Effective date of registration: 20200426 Granted publication date: 20161130 Pledgee: Agricultural Bank of China Limited by Share Ltd Chengdu Qingyang branch Pledgor: Chengdu Easton Biopharmaceuticals Co.,Ltd. Registration number: Y2020980001782 |
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PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20210610 Granted publication date: 20161130 Pledgee: Agricultural Bank of China Limited by Share Ltd. Chengdu Qingyang branch Pledgor: Chengdu Easton Biopharmaceuticals Co.,Ltd. Registration number: Y2020980001782 |