CN1813674A - Sodium vitamin C formulation for intravenous administration and its preparing method - Google Patents
Sodium vitamin C formulation for intravenous administration and its preparing method Download PDFInfo
- Publication number
- CN1813674A CN1813674A CN 200510048174 CN200510048174A CN1813674A CN 1813674 A CN1813674 A CN 1813674A CN 200510048174 CN200510048174 CN 200510048174 CN 200510048174 A CN200510048174 A CN 200510048174A CN 1813674 A CN1813674 A CN 1813674A
- Authority
- CN
- China
- Prior art keywords
- injection
- preparation
- water
- sodium ascorbate
- sodium
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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 description 21
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 title claims description 9
- 229930003268 Vitamin C Natural products 0.000 title claims description 9
- 238000000034 method Methods 0.000 title claims description 9
- 235000019154 vitamin C Nutrition 0.000 title claims description 9
- 239000011718 vitamin C Substances 0.000 title claims description 9
- 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 description 6
- 238000009472 formulation Methods 0.000 title claims description 6
- 239000000203 mixture Substances 0.000 title claims description 6
- 229910052708 sodium Inorganic materials 0.000 title claims description 6
- 239000011734 sodium Substances 0.000 title claims description 6
- 238000001990 intravenous administration Methods 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims abstract description 28
- 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 abstract description 23
- 235000010378 sodium ascorbate Nutrition 0.000 claims description 22
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims description 22
- 229960005055 sodium ascorbate Drugs 0.000 claims description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
- 239000008215 water for injection Substances 0.000 claims description 17
- 230000003204 osmotic effect Effects 0.000 claims description 11
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 10
- 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 10
- 239000008103 glucose Substances 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 8
- 230000001954 sterilising effect Effects 0.000 claims description 8
- 238000003756 stirring Methods 0.000 claims description 6
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 4
- 238000001802 infusion Methods 0.000 claims description 4
- 238000002347 injection Methods 0.000 claims description 4
- 239000007924 injection Substances 0.000 claims description 4
- 229920004934 Dacron® Polymers 0.000 claims description 3
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 3
- 238000010521 absorption reaction Methods 0.000 claims description 3
- 238000013019 agitation Methods 0.000 claims description 3
- 238000005262 decarbonization Methods 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 238000007689 inspection Methods 0.000 claims description 3
- 239000012528 membrane Substances 0.000 claims description 3
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 3
- 230000001105 regulatory effect Effects 0.000 claims description 3
- 239000010936 titanium Substances 0.000 claims description 3
- 229910052719 titanium Inorganic materials 0.000 claims description 3
- 238000005303 weighing Methods 0.000 claims description 3
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 claims description 2
- 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 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 2
- 235000001014 amino acid Nutrition 0.000 claims description 2
- 150000001413 amino acids Chemical class 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
- 235000001727 glucose Nutrition 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 2
- 239000001103 potassium chloride Substances 0.000 claims description 2
- 235000011164 potassium chloride Nutrition 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- 235000002639 sodium chloride Nutrition 0.000 claims description 2
- 239000001540 sodium lactate Substances 0.000 claims description 2
- 229940005581 sodium lactate Drugs 0.000 claims description 2
- 235000011088 sodium lactate Nutrition 0.000 claims description 2
- 239000000811 xylitol Substances 0.000 claims description 2
- 235000010447 xylitol Nutrition 0.000 claims description 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 2
- 229960002675 xylitol Drugs 0.000 claims description 2
- 238000010253 intravenous injection Methods 0.000 abstract 2
- 230000003647 oxidation Effects 0.000 description 4
- 238000007254 oxidation reaction Methods 0.000 description 4
- 239000003814 drug Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 229940088594 vitamin Drugs 0.000 description 2
- 229930003231 vitamin Natural products 0.000 description 2
- 235000013343 vitamin Nutrition 0.000 description 2
- 239000011782 vitamin Substances 0.000 description 2
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000012670 alkaline solution Substances 0.000 description 1
- 230000037354 amino acid metabolism Effects 0.000 description 1
- 230000000890 antigenic effect Effects 0.000 description 1
- 235000010323 ascorbic acid Nutrition 0.000 description 1
- 239000011668 ascorbic acid Substances 0.000 description 1
- 229960005070 ascorbic acid Drugs 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
- 239000003610 charcoal Substances 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 229910052802 copper Inorganic materials 0.000 description 1
- 239000010949 copper Substances 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000001784 detoxification Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 125000002587 enol group Chemical group 0.000 description 1
- 210000003701 histiocyte Anatomy 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
- 231100000957 no side effect Toxicity 0.000 description 1
- 239000013618 particulate matter Substances 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention discloses a preparation for intravenous injection administration. In the concrete, it discloses a vitamin c sodium preparation for intravenous injection administration and its preparation method.
Description
Technical field
The invention discloses a kind of preparation that is used for intravenously administrable, more specifically, the invention discloses sodium vitamin C formulation that is used for intravenously administrable and preparation method thereof.
Background technology
Vitamin C is ascorbic acid again, is a kind of water soluble vitamins.Vitamin C in the intravital major function of people is: participate in the synthetic of matter between synthetic, the collagen protein of amino acid metabolism, neurotransmitter and histiocyte, can reduce the permeability of blood capillary, solidifying of accelerate blood, stimulate coagulation function, promote that ferrum absorbs at enteral, impel rate and blood-lipid decreased, increase resistance infecting, participate in function of detoxification, and the effect that antfhistamine effect is arranged and stop carcinogen (nitrosamine) to generate.
Because ascorbic enol form chemical constitution makes it extremely unstable, meet the easy oxidation of air, variable color, stable in acid solution, easy oxidized decomposition in neutrality or alkaline solution, metal ion such as ferrum, copper can quicken its oxidation rate, is least stable in all vitamins.So thereby the stable Vitamin C preparation of urgent clinical needs guarantees drug safety.
Summary of the invention
The invention discloses:
1. sodium vitamin C formulation that is used for intravenously administrable comprises following component: sodium ascorbate 0.04%～50.0%, and is osmotic pressure regulator 0.8%～80.0% (too high?), water for injection 15.0%～99.1%.
2. above-mentioned 1 described preparation, wherein sodium ascorbate 0.1%～10.0%, osmotic pressure regulator 4.0%～50%, water for injection 50.0%～94.8%.
3. above-mentioned 1 described preparation, wherein one or more in osmotic pressure regulator sodium chloride, glucose, mannitol, xylitol, potassium chloride, sodium lactate, the aminoacid.
4. above-mentioned 1 described preparation, wherein sodium ascorbate 0.2%, glucose 5.0%, water for injection 94.8%.
5. above-mentioned 1 described preparation, wherein sodium ascorbate 1.0%, glucose 5.0%, water for injection 94.0%.
6. the preparation method of the arbitrary described preparation of above-mentioned 1-5 may further comprise the steps:
(1) infusion bottle, rubber stopper, dacron membrane are handled by the conventional requirement of injection;
(2) preparation of medicinal liquid;
(3) product detect in the middle of: the content of taking liquid mensuration pH value and sodium ascorbate, osmotic pressure regulator;
(4) canned: after its content and pH value were qualified, fine straining was qualified to clarity, canned, blooming, jumped a queue, rolls lid;
(5) pressure sterilizing;
(6) full inspection.
7. above-mentioned 6 described methods, wherein the medicinal liquid collocation method of step (2) be take by weighing recipe quantity sodium ascorbate in Agitation Tank, add water for injection, stirring and dissolving.Add osmotic pressure regulator again, stirring and dissolving is added water for injection to recipe quantity, adds an amount of needle-use activated carbon, and charcoal absorption 30 minutes with titanium filter stick filtering decarbonization, is regulated the ph value, fine straining.
Preparation finishes, and packs.
8. above-mentioned 6 described methods, wherein pressure sterilizing is 105～121 ℃ of pressure sterilizings.
Sodium vitamin C formulation disclosed by the invention is thought ratio with prior art, and excellent results is as follows:
(1) selected the transfusion dosage form,, and reduced secondary pollution and guaranteed the injection quality for the clinical worker operation has brought convenience.
(2) stability of sodium ascorbate improves a lot than ascorbic stability.
The sodium ascorbate transfusion that is made by said method all complies with relevant regulations in the check of items such as content, pyrogen, aseptic, pH, clarity, particulate matter, and no antigenic type has no side effect.Thereby overcome shortcomings such as the easy oxidation of existing Cevalin, and make product stability better, curative effect is more definite.Its process characteristic is that the oxidation resistance of medicine behind the salify strengthens, good stability, and medication is safer, for the clinical worker operation has brought convenience, provides a kind of economical and practical novel form for clinical.
The specific embodiment
Following examples only further specify the present invention, should not understand limitation of the present invention.
Unless stated otherwise, the percentage ratio among the present invention all is weight percentage.
The raw material source:
Embodiment 1: component is as follows:
Sodium ascorbate 0.2%
Glucose 5%
Water for injection 94.8%
Preparation method is as follows:
(1) infusion bottle, rubber stopper, dacron membrane are handled by the conventional requirement of injection, and be standby
(2) preparation of medicinal liquid:
Take by weighing the 200g sodium ascorbate in Agitation Tank, add water for injection 50000g, stirring and dissolving.Add glucose 5000g, stirring and dissolving is added water for injection to 100000g, adds the 10g needle-use activated carbon, charcoal absorption 30 minutes, and with titanium filter stick filtering decarbonization, regulating pH value is 6.0, fine straining.
(3) product detect in the middle of: the content of taking liquid mensuration ph value and sodium ascorbate, osmotic pressure regulator.
(4) fill: after its content and pH value were qualified, fine straining value clarity was qualified, by the fill of 100ml/ infusion bottle, blooming, jump a queue, roll lid.
(5) pressure sterilizing: 115 ℃ of pressure sterilizings 30 minutes, the cooling of spray hot water is offerd for sale.
(6) full inspection.
Preparation finishes, and packs, and promptly obtains the sodium ascorbate transfusion.
Embodiment 2: the sodium ascorbate transfusion, and component following (all being weight percentage):
Sodium ascorbate 1.0%
Glucose 5%
Water for injection 94.0%
Preparation method is with embodiment 1.
Embodiment 3: the sodium ascorbate transfusion, and component following (all being weight percentage):
Sodium ascorbate 1.0%
Glucose 5%
Water for injection 94.0%
Preparation method is with embodiment 1.
Claims (8)
1. a sodium vitamin C formulation that is used for intravenously administrable comprises following component: sodium ascorbate 0.04%～50.0%, osmotic pressure regulator 0.8%～80.0%, water for injection 15.0%～99.1%.
2. the described preparation of claim 1, wherein sodium ascorbate 0.1%～10.0%, osmotic pressure regulator 4.0%～50.0%, water for injection 50.0%～94.8%.
3. the described preparation of claim 1, wherein one or more in osmotic pressure regulator sodium chloride, glucose, mannitol, xylitol, potassium chloride, sodium lactate, the aminoacid.
4. the described preparation of claim 1, wherein sodium ascorbate 0.2%, glucose 5.0%, water for injection 94.8%.
5. the described preparation of claim 1, wherein sodium ascorbate 1.0%, glucose 5.0%, water for injection 94.0%.
6. the preparation method of the arbitrary described preparation of claim 1-5 may further comprise the steps:
(1) infusion bottle, rubber stopper, dacron membrane are handled by the conventional requirement of injection;
(2) preparation of medicinal liquid;
(3) product detect in the middle of: the content of taking liquid mensuration pH value and sodium ascorbate, osmotic pressure regulator;
(4) canned: after its content and pH value were qualified, fine straining was qualified to clarity, canned, blooming, jumped a queue, rolls lid;
(5) pressure sterilizing;
(6) full inspection.
7. the described method of claim 6, wherein the medicinal liquid collocation method of step (2) be take by weighing recipe quantity sodium ascorbate in Agitation Tank, add water for injection, stirring and dissolving.Add osmotic pressure regulator again, stirring and dissolving is added water for injection to recipe quantity, adds an amount of needle-use activated carbon, and charcoal absorption 30 minutes with titanium filter stick filtering decarbonization, is regulated the ph value, fine straining, and preparation finishes, and packs.
8. the described method of claim 6, wherein pressure sterilizing is 105～121 ℃ of pressure sterilizings.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510048174 CN1813674A (en) | 2005-12-12 | 2005-12-12 | Sodium vitamin C formulation for intravenous administration and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510048174 CN1813674A (en) | 2005-12-12 | 2005-12-12 | Sodium vitamin C formulation for intravenous administration and its preparing method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1813674A true CN1813674A (en) | 2006-08-09 |
Family
ID=36906110
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510048174 Pending CN1813674A (en) | 2005-12-12 | 2005-12-12 | Sodium vitamin C formulation for intravenous administration and its preparing method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1813674A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8999313B2 (en) | 2012-09-11 | 2015-04-07 | Norgine Bv | Compositions |
| CN105998055A (en) * | 2016-05-11 | 2016-10-12 | 广西圣保堂健康产业股份有限公司 | Injection containing sodium ascorbate and preparing method thereof |
| US9592252B2 (en) | 2011-03-11 | 2017-03-14 | Norgine Bv | Colonoscopy—preparation |
-
2005
- 2005-12-12 CN CN 200510048174 patent/CN1813674A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9592252B2 (en) | 2011-03-11 | 2017-03-14 | Norgine Bv | Colonoscopy—preparation |
| US10646512B2 (en) | 2011-03-11 | 2020-05-12 | Norgine Bv | Colonoscopy - preparation |
| US10780112B2 (en) | 2011-03-11 | 2020-09-22 | Norgine Bv | Colonoscopy-preparation |
| US10792306B2 (en) | 2011-03-11 | 2020-10-06 | Norgine Bv | Colonoscopy—preparation |
| US11529368B2 (en) | 2011-03-11 | 2022-12-20 | Norgine Bv | Colonoscopy—preparation |
| US8999313B2 (en) | 2012-09-11 | 2015-04-07 | Norgine Bv | Compositions |
| US9326969B2 (en) | 2012-09-11 | 2016-05-03 | Norgine Bv | Compositions |
| US9707297B2 (en) | 2012-09-11 | 2017-07-18 | Norgine Bv | Compositions |
| US10016504B2 (en) | 2012-09-11 | 2018-07-10 | Norgine Bv | Compositions |
| US10918723B2 (en) | 2012-09-11 | 2021-02-16 | Norgine Bv | Colon cleansing compositions and methods of use |
| US12083179B2 (en) | 2012-09-11 | 2024-09-10 | Norgine Bv | Colon cleansing compositions and method of use |
| CN105998055A (en) * | 2016-05-11 | 2016-10-12 | 广西圣保堂健康产业股份有限公司 | Injection containing sodium ascorbate and preparing method thereof |
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
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