CN1279904C - 一种含维生素c钠的维生素c组合物 - Google Patents
一种含维生素c钠的维生素c组合物 Download PDFInfo
- Publication number
- CN1279904C CN1279904C CN 200410033951 CN200410033951A CN1279904C CN 1279904 C CN1279904 C CN 1279904C CN 200410033951 CN200410033951 CN 200410033951 CN 200410033951 A CN200410033951 A CN 200410033951A CN 1279904 C CN1279904 C CN 1279904C
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- Prior art keywords
- vitamin
- sodium
- composition
- injection
- aseptic powder
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- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 title claims abstract description 254
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 title claims abstract description 123
- 229930003268 Vitamin C Natural products 0.000 title claims abstract description 123
- 235000019154 vitamin C Nutrition 0.000 title claims abstract description 123
- 239000011718 vitamin C Substances 0.000 title claims abstract description 123
- 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 title claims abstract description 82
- 239000011734 sodium Substances 0.000 title claims abstract description 82
- 229910052708 sodium Inorganic materials 0.000 title claims abstract description 82
- 239000000203 mixture Substances 0.000 title claims abstract description 53
- 239000011782 vitamin Substances 0.000 claims abstract description 84
- 238000002347 injection Methods 0.000 claims abstract description 53
- 239000007924 injection Substances 0.000 claims abstract description 53
- 239000000843 powder Substances 0.000 claims abstract description 43
- 239000003814 drug Substances 0.000 claims abstract description 12
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 8
- 229930003231 vitamin Natural products 0.000 claims description 82
- 235000013343 vitamin Nutrition 0.000 claims description 82
- 229940088594 vitamin Drugs 0.000 claims description 82
- 150000003722 vitamin derivatives Chemical class 0.000 claims description 82
- 238000002360 preparation method Methods 0.000 claims description 39
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical group [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 30
- 235000015424 sodium Nutrition 0.000 claims description 16
- 239000000243 solution Substances 0.000 claims description 15
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 12
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 9
- 238000004108 freeze drying Methods 0.000 claims description 7
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 7
- 239000000463 material Substances 0.000 claims description 6
- 239000002994 raw material Substances 0.000 claims description 6
- 230000003750 conditioning effect Effects 0.000 claims description 5
- 239000002904 solvent Substances 0.000 claims description 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 4
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 4
- 239000003513 alkali Substances 0.000 claims description 3
- 230000007935 neutral effect Effects 0.000 claims description 3
- 201000010099 disease Diseases 0.000 claims description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 2
- 238000004806 packaging method and process Methods 0.000 claims description 2
- 230000002265 prevention Effects 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- 235000002639 sodium chloride Nutrition 0.000 claims description 2
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims description 2
- RGHNJXZEOKUKBD-SQOUGZDYSA-N D-gluconic acid Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims 2
- UMGDCJDMYOKAJW-UHFFFAOYSA-N thiourea Chemical compound NC(N)=S UMGDCJDMYOKAJW-UHFFFAOYSA-N 0.000 claims 2
- LEVWYRKDKASIDU-QWWZWVQMSA-N D-cystine Chemical compound OC(=O)[C@H](N)CSSC[C@@H](N)C(O)=O LEVWYRKDKASIDU-QWWZWVQMSA-N 0.000 claims 1
- RGHNJXZEOKUKBD-UHFFFAOYSA-N D-gluconic acid Natural products OCC(O)C(O)C(O)C(O)C(O)=O RGHNJXZEOKUKBD-UHFFFAOYSA-N 0.000 claims 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 claims 1
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims 1
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 claims 1
- 235000009508 confectionery Nutrition 0.000 claims 1
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Natural products SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 claims 1
- 235000018417 cysteine Nutrition 0.000 claims 1
- 229960003067 cystine Drugs 0.000 claims 1
- 239000000174 gluconic acid Substances 0.000 claims 1
- 235000012208 gluconic acid Nutrition 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 235000011167 hydrochloric acid Nutrition 0.000 claims 1
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims 1
- 229940079827 sodium hydrogen sulfite Drugs 0.000 claims 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 claims 1
- 235000010262 sodium metabisulphite Nutrition 0.000 claims 1
- 235000010265 sodium sulphite Nutrition 0.000 claims 1
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 claims 1
- 235000019345 sodium thiosulphate Nutrition 0.000 claims 1
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 claims 1
- 229940079593 drug Drugs 0.000 abstract description 6
- 230000001105 regulatory effect Effects 0.000 abstract 3
- WIGIZIANZCJQQY-UHFFFAOYSA-N 4-ethyl-3-methyl-N-[2-[4-[[[(4-methylcyclohexyl)amino]-oxomethyl]sulfamoyl]phenyl]ethyl]-5-oxo-2H-pyrrole-1-carboxamide Chemical compound O=C1C(CC)=C(C)CN1C(=O)NCCC1=CC=C(S(=O)(=O)NC(=O)NC2CCC(C)CC2)C=C1 WIGIZIANZCJQQY-UHFFFAOYSA-N 0.000 abstract 2
- 238000004500 asepsis Methods 0.000 abstract 1
- 239000007788 liquid Substances 0.000 description 38
- 239000007789 gas Substances 0.000 description 31
- 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 24
- 238000012856 packing Methods 0.000 description 20
- 239000000284 extract Substances 0.000 description 18
- 238000000034 method Methods 0.000 description 11
- 230000000694 effects Effects 0.000 description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 10
- 238000004519 manufacturing process Methods 0.000 description 9
- 238000003756 stirring Methods 0.000 description 9
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 8
- 239000007787 solid Substances 0.000 description 8
- 239000008215 water for injection Substances 0.000 description 8
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 7
- 229910052799 carbon Inorganic materials 0.000 description 7
- 238000010790 dilution Methods 0.000 description 7
- 239000012895 dilution Substances 0.000 description 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
- 229960005070 ascorbic acid Drugs 0.000 description 6
- 230000000052 comparative effect Effects 0.000 description 6
- 238000002425 crystallisation Methods 0.000 description 6
- 230000008025 crystallization Effects 0.000 description 6
- 238000000605 extraction Methods 0.000 description 5
- 238000009472 formulation Methods 0.000 description 4
- 238000009413 insulation Methods 0.000 description 4
- 229910052757 nitrogen Inorganic materials 0.000 description 4
- 239000002253 acid Substances 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- 239000002131 composite material Substances 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 239000000706 filtrate Substances 0.000 description 3
- 230000036541 health Effects 0.000 description 3
- 238000005406 washing Methods 0.000 description 3
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 238000007865 diluting Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000003182 parenteral nutrition solution Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000001953 recrystallisation Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 238000001291 vacuum drying Methods 0.000 description 2
- 238000010792 warming Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 239000012670 alkaline solution Substances 0.000 description 1
- 150000004703 alkoxides Chemical class 0.000 description 1
- 230000037354 amino acid metabolism Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000009529 body temperature measurement Methods 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 230000000711 cancerogenic effect Effects 0.000 description 1
- 231100000357 carcinogen Toxicity 0.000 description 1
- 239000003183 carcinogenic agent Substances 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 230000009849 deactivation Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000011082 depyrogenation Methods 0.000 description 1
- 238000001784 detoxification Methods 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
- 239000002858 neurotransmitter agent Substances 0.000 description 1
- XKLJHFLUAHKGGU-UHFFFAOYSA-N nitrous amide Chemical compound ON=N XKLJHFLUAHKGGU-UHFFFAOYSA-N 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 230000001590 oxidative effect Effects 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 238000013441 quality evaluation Methods 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 239000011435 rock Substances 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- POECFFCNUXZPJT-UHFFFAOYSA-M sodium;carbonic acid;hydrogen carbonate Chemical compound [Na+].OC(O)=O.OC([O-])=O POECFFCNUXZPJT-UHFFFAOYSA-M 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000013022 venting Methods 0.000 description 1
- 150000003700 vitamin C derivatives Chemical class 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
Abstract
Description
样品 | 各组分重量比 | 溶液pH值 | 产气量(ml) | |||
维生素C钠 | 维生素C | 碳酸氢钠 | 碳酸钠 | |||
市售样品 | 0 | 80 | 0 | 20 | 4.82 | 51.9 |
对比实施例1 | 0 | 71.6 | 28.4 | 0 | 4.84 | 104 |
对比实施例2 | 100 | 0 | 0 | 0 | 7.69 | 0 |
实施例1 | 99.5 | 0.5 | 0 | 0 | 6.47 | 0 |
实施例2 | 99 | 1 | 0 | 0 | 6.21 | 0 |
实施例3 | 98.2 | 1.8 | 0 | 0 | 5.97 | 0 |
实施例4 | 95.7 | 4.3 | 0 | 0 | 5.54 | 0 |
实施例5 | 88 | 12 | 0 | 0 | 5.01 | 0 |
实施例6 | 84.7 | 15.3 | 0 | 0 | 4.85 | 0 |
实施例7 | 78.6 | 21.4 | 0 | 0 | 4.66 | 0 |
实施例8 | 71.4 | 28.6 | 0 | 0 | 4.52 | 0 |
实施例9 | 50 | 50 | 0 | 0 | 4.03 | 0 |
实施例10 | 59.3 | 35.4 | 0 | 5.3 | 4.69 | 11.2 |
实施例11 | 62.7 | 28.7 | 0 | 8.6 | 5.98 | 20.1 |
实施例12 | 29.6 | 60.3 | 0 | 10.1 | 4.54 | 22.7 |
实施例13 | 9.4 | 80.5 | 0 | 10.1 | 4.11 | 21.9 |
实施例14 | 90 | 8 | 0 | 2 | 5.67 | 2.6 |
实施例15 | 57.5 | 34.4 | 8.1 | 0 | 4.95 | 23.9 |
实施例16 | 58.9 | 35.2 | 1.7 | 4.2 | 4.88 | 14.3 |
实施例17(冻干) | 71.4 | 28.6 | 0 | 0 | 4.57 | 0 |
样品 | 抽取药液操作方便性比较 |
市售样品 | 溶解时压力过大,有气体从针口处排出。待气体不排出后抽取药液,进针时注射器活塞突然受到压力难以把持,拔出针头时药液在反作用力作用下容易喷出。 |
对比实施例1 | 溶解时压力过大,有气体从针口处排出。待气体不排出后抽取药液,进针时突然受到压力难以把持,拔出针头时药液在反作用力作用下容易喷出。 |
实施例1 | 普通方式抽取药液,方便 |
实施例2 | 普通方式抽取药液,方便 |
实施例3 | 普通方式抽取药液,方便 |
实施例4 | 普通方式抽取药液,方便 |
实施例5 | 普通方式抽取药液,方便 |
实施例6 | 普通方式抽取药液,方便 |
实施例7 | 普通方式抽取药液,方便 |
实施例8 | 普通方式抽取药液,方便 |
实施例9 | 普通方式抽取药液,方便 |
实施例10 | 溶解时针口处无气体排出。注射器活塞容易把持。由于内压作用、抽取药液比普通方式方便。 |
实施例11 | 溶解时针口处无气体排出。注射器活塞容易把持。由于内压作用、抽取药液比普通方式方便。 |
实施例12 | 溶解时针口处无气体排出。注射器活塞容易把持。由于内压作用、抽取药液比普通方式方便。 |
实施例13 | 溶解时针口处无气体排出。注射器活塞容易把持。由于内压作用、抽取药液比普通方式方便。 |
实施例14 | 溶解时针口处无气体排出。注射器活塞容易把持。由于内压作用、抽取药液比普通方式方便。 |
实施例15 | 溶解时针口处无气体排出。注射器活塞容易把持。由于内压作用、抽取药液比普通方式方便。 |
实施例16 | 溶解时针口处无气体排出。注射器活塞容易把持。由于内压作用、抽取药液比普通方式方便。 |
实施例17 | 普通方式抽取药液,方便 |
实施例18 | 普通方式抽取药液,方便 |
样品 | 吸收度(420nm) | |
0天样品 | 10天样品 | |
市售样品 | 0.016 | 0.036 |
实施例1 | 0.012 | 0.013 |
实施例2 | 0.012 | 0.013 |
实施例3 | 0.012 | 0.013 |
实施例4 | 0.012 | 0.013 |
实施例5 | 0.012 | 0.013 |
实施例6 | 0.012 | 0.013 |
实施例7 | 0.012 | 0.013 |
实施例8 | 0.012 | 0.013 |
实施例9 | 0.012 | 0.014 |
Claims (14)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN 200410033951 CN1279904C (zh) | 2004-04-21 | 2004-04-21 | 一种含维生素c钠的维生素c组合物 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN 200410033951 CN1279904C (zh) | 2004-04-21 | 2004-04-21 | 一种含维生素c钠的维生素c组合物 |
Publications (2)
Publication Number | Publication Date |
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CN1689564A CN1689564A (zh) | 2005-11-02 |
CN1279904C true CN1279904C (zh) | 2006-10-18 |
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CN 200410033951 Expired - Lifetime CN1279904C (zh) | 2004-04-21 | 2004-04-21 | 一种含维生素c钠的维生素c组合物 |
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CN (1) | CN1279904C (zh) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102558114B (zh) * | 2011-12-28 | 2015-12-09 | 上海新亚药业有限公司 | 一种维生素c原料药的制备方法 |
CN104606209A (zh) * | 2014-12-30 | 2015-05-13 | 王大光 | 一种注射用复方维生素药物组合物及其制备方法 |
CN104490903B (zh) * | 2014-12-30 | 2017-11-21 | 王大光 | 一种复方维生素注射液药物组合物及其制备方法 |
CN106491531B (zh) * | 2017-01-11 | 2019-11-26 | 河北天成药业股份有限公司 | 一种注射用维生素c的生产工艺 |
EP3456354A4 (en) * | 2017-07-20 | 2020-02-26 | Delta-Fly Pharma, Inc. | NEW MALIGNANT ANTI-TUMOR AGENT BASED ON THE SPECIFICITY OF CANCER CELL METABOLISM |
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