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
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- 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
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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 |
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| CN1813674A true CN1813674A (en) | 2006-08-09 |
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| CN 200510048174 Pending CN1813674A (en) | 2005-12-12 | 2005-12-12 | Sodium vitamin C formulation for intravenous administration and its preparing method |
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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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