CN1813681A - Sodium vitamin C powder for injection and its preparing method - Google Patents
Sodium vitamin C powder for injection and its preparing method Download PDFInfo
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- CN1813681A CN1813681A CN 200510048175 CN200510048175A CN1813681A CN 1813681 A CN1813681 A CN 1813681A CN 200510048175 CN200510048175 CN 200510048175 CN 200510048175 A CN200510048175 A CN 200510048175A CN 1813681 A CN1813681 A CN 1813681A
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Abstract
The present invention relates to a vitamin powder injection for injection, in the concrete, it relates to a vitamin C sodium powder injection for injection and its preparation method.
Description
Technical field
The present invention relates to a kind of injection vitamin powder pin, more specifically, the invention discloses a kind of sodium vitamin C powder for injection 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.
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:
An injection contain the sodium vitamin C powder pin, it is characterized in that unit dose contains sodium ascorbate 25mg-10g.
2. above-mentioned 1 powder pin, wherein unit dose contains sodium ascorbate 100mg.
3. above-mentioned 1 powder pin, wherein unit dose contains sodium ascorbate 250mg.
4. above-mentioned 1 powder pin, wherein unit dose contains sodium ascorbate 500mg.
5. the arbitrary described powder pin of above-mentioned 1-4, wherein also contain excipient or/and cosolvent or/and the PH regulator or/and antioxidant.
6. the arbitrary described powder pin of above-mentioned 1-5, wherein excipient is one of lactose, sorbitol, mannitol, xylitol, glucose, polyvidone, Macrogol 4000.
7. the arbitrary described powder pin of above-mentioned 1-5, wherein cosolvent is one of sodium chloride, sodium dihydrogen phosphate, sodium hydrogen phosphate.
8. the arbitrary described powder pin of above-mentioned 1-5, wherein antioxidant is vitamin C, sodium sulfite, sodium sulfite, sodium pyrosulfite, one of metal chelating agent edetate, citric acid and citrate, tartaric acid and tartrate.
9. the preparation method of the arbitrary described powder pin of above-mentioned 1-9 comprises lyophilization or aseptic subpackaged method.More specifically, the invention discloses:
1. prescription content:
Injection sodium ascorbate dosage form is an injectable powder, and the medicine component is: contain sodium ascorbate 25mg-10g in every injection sodium ascorbate medicine, but optimum is 100mg-1g; The character of this medicine is white, off-white color or little yellow block or powder; This product be must dilute before the intravenous drip, sodium chloride injection, 5% glucose injection, compound sodium chloride injection, Amino Acid Compound Injection, Xylitol injection (5%), compound sodium lactate injection generally used.This product can intravenous drip, also can intramuscular injection.
2. preparation method:
The preparation of sodium vitamin C powder for injection of the present invention has:
A, elder generation are prepared into aseptic powder (seeing embodiment 1), packing behind the mixing with sodium ascorbate;
B, lyophilization (seeing embodiment 2);
C, can prepare packing (seeing embodiment 3) after the sodium ascorbate aseptic powder with aseptic spray drying method.
But above three kinds of method best practice are A.
Sodium vitamin C powder for injection with lyophilization and the preparation of aseptic spray dry can contain excipient, cosolvent.Specifically can be lactose, sorbitol, mannitol, xylitol, glucose, polyvidone, Macrogol 4000, sodium chloride, sodium dihydrogen phosphate, sodium hydrogen phosphate etc., can be separately, also can mix use in varing proportions, total consumption be recipe quantity 0～25%, be preferably 5～10%.The pH regulator agent is sodium bicarbonate, sodium carbonate, ammonia, sodium hydroxide, hydrochloric acid, acetic acid, sulphuric acid, lactic acid, citric acid, succinic acid, phosphoric acid, nitric acid, tartaric acid etc., can be separately, also can mix use in varing proportions, total consumption be recipe quantity 0～3%, be preferably 0～2%.Antioxidative stabilizer is vitamin C, sodium sulfite, sodium sulfite, sodium pyrosulfite, metal chelating agent edetate, citric acid and citrate, tartaric acid and tartrate, can be separately, also can mix use in varing proportions, total consumption be recipe quantity 0.005～1%, be preferably 0.01～0.6%, to improve the antioxygenic property and the stability of product.
The present invention overcome shortcomings such as the easy oxidation of existing Cevalin, invent and prepared sodium vitamin C powder for injection, make product stability better, curative effect is more definite.
And sodium vitamin C powder for injection, its process characteristic is that the oxidation resistance of medicine behind the salify strengthens, good stability, and medication is safer, packs spry and lightly, is convenient to accumulating.
The specific embodiment
Embodiments of the invention only are further detailed the present invention, should not be construed as restriction of the present invention.
Embodiment 1 sodium vitamin C powder for injection, every bottle contains the total effective ingredient 250mg of injection sodium ascorbate, prepares 1000 altogether.
Sodium ascorbate (aseptic powder) 250g
Make 1000 bottles
Preparation method: precision takes by weighing sodium ascorbate (aseptic powder) 250g under aseptic condition, insert uniform mixing in the pressed powder mixer, the gained raw material changes the sterile preparation workshop over to, by the packing of every effective ingredient 250mg delicate metering, gland promptly gets 1000 sodium vitamin C powder for injection.
Embodiment 2 injection sodium ascorbate freeze-dried powders, every bottle contains the total effective ingredient 100mg of injection sodium ascorbate, prepares 1000 altogether.
Sodium ascorbate 100g (in effective ingredient)
Mannitol 20g
Water for injection is an amount of
Make 1000 bottles
Preparation method 1: with above sodium ascorbate 100g (in effective ingredient), mannitol 20g, be added in the water for injection, stirring down, the adding sodium sulfite makes material dissolution and transfers Ph4.5～7.5, or sodium sulfite added in the water for injection dissolve, vitaminize C sodium, mannitol, stirring makes material dissolution and transfers pH4.5～7.5, or mannitol added in the water for injection dissolve, add sodium sulfite, sodium ascorbate, stirring makes material dissolution and transfers pH4.5～7.5, adds the injection-use activated carbon of 0.01-0.5%, stirred 15-30 minute, through 0.45 μ m and 0.22 μ m filtering with microporous membrane, filtrate quantitatively is sub-packed in the vial again for filtering active carbon, medicinal liquid, place freezer dryer, be cooled to-25 ℃～-30 ℃ and keep being cooled to-40 ℃～-45 ℃ again after 2 hours, open vacuum, slowly be warming up to-5 ℃～0 ℃ sublimation drying, stop drying less than 1% to moisture, lyophilization is finished, and the gland packing promptly gets 1000 of every bottle of injection sodium ascorbaties that contains effective composition 100mg.
Preparation method 2: with above sodium ascorbate 100g (in effective ingredient), mannitol 20g, be added in the water for injection, stirring down, the adding sodium sulfite makes material dissolution and transfers pH4.5～7.5, or sodium sulfite added in the water for injection dissolve, vitaminize C sodium, mannitol, stirring makes material dissolution and transfers pH4.5～7.5, or mannitol added in the water for injection dissolve, add sodium sulfite, sodium ascorbate, stirring makes material dissolution and transfers pH4.5～7.5, add the injection-use activated carbon of 0.01-0.5%, stirred the filtering active carbon 15-30 minute, medicinal liquid is again through 0.45 μ m and 0.22 μ m filtering with microporous membrane, filtrate is sub-packed in the pallet, places freezer dryer, is cooled to-25 ℃～-30 ℃ and keeps after 2 hours, be cooled to-40 ℃～-45 ℃ again, open vacuum, slowly be warming up to-5 ℃～0 ℃ sublimation drying, stop drying less than 1% to moisture, lyophilization is finished, grinding and sieving.The back gained raw material that sieves changes the sterile preparation workshop over to, quantitatively is sub-packed in the vial, and the gland packing promptly gets 1000 of every bottle of injection sodium ascorbaties that contains effective composition 100mg.
Embodiment 3 sodium vitamin C powder for injection, every bottle contains injection sodium ascorbate effective ingredient 500mg, prepares 1000 altogether.
Sodium ascorbate 500g (in effective ingredient)
Water for injection is an amount of
Make 1000 bottles
Preparation method: precision takes by weighing sodium ascorbate 500g (in effective ingredient), sodium ascorbate is added in the water for injection, fully after the dissolving, the injection-use activated carbon that adds 0.01-0.5%, stirred 30 minutes, the filtering active carbon, medicinal liquid is again through 0.45 μ m and 0.22 μ m filtering with microporous membrane, filtrate is low temperature spray drying under aseptic condition, dry gained raw material changes the sterile preparation workshop over to, contain effective composition 500mg precision by every and quantitatively be sub-packed in the vial, gland packing promptly gets 1000 of every bottle of injection sodium ascorbaties that contains effective composition 500mg.
Claims (9)
1. an injection contains the powder pin of sodium ascorbate, it is characterized in that unit dose contains vitamin 25mg-10g.
2. the described powder pin of claim 1, wherein unit dose contains sodium ascorbate 100mg.
3. the described powder pin of claim 1, wherein unit dose contains sodium ascorbate 250mg.
4. the described powder pin of claim 1, wherein unit dose contains sodium ascorbate 500mg.
5. the arbitrary described powder pin of claim 1-4, wherein also contain excipient or/and cosolvent or/and the PH regulator or/and antioxidant.
6. the arbitrary described powder pin of claim 1-5, wherein excipient is one of lactose, sorbitol, mannitol, xylitol, glucose, polyvidone, Macrogol 4000.
7. the arbitrary described powder pin of claim 1-5, wherein cosolvent is one of sodium chloride, sodium dihydrogen phosphate, sodium hydrogen phosphate.
8. the arbitrary described powder pin of claim 1-5, wherein antioxidant is vitamin C, sodium sulfite, sodium sulfite, sodium pyrosulfite, one of metal chelating agent edetate, citric acid and citrate, tartaric acid and tartrate.
9. the preparation method of the arbitrary described powder pin of claim 1-8 comprises lyophilization or aseptic subpackaged method.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510048175 CN1813681A (en) | 2005-12-12 | 2005-12-12 | Sodium vitamin C powder for injection and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510048175 CN1813681A (en) | 2005-12-12 | 2005-12-12 | Sodium vitamin C powder for injection and its preparing method |
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| Publication Number | Publication Date |
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| CN1813681A true CN1813681A (en) | 2006-08-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510048175 Pending CN1813681A (en) | 2005-12-12 | 2005-12-12 | Sodium vitamin C powder for injection and its preparing method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103239414A (en) * | 2012-02-09 | 2013-08-14 | 陕西博森生物制药股份集团有限公司 | Vitamin C freeze-dried powder for injection and preparation method thereof |
| CN103920154A (en) * | 2014-04-11 | 2014-07-16 | 成都苑东药业有限公司 | Tetracaine hydrochloride pharmaceutical composition for injection and preparation method of pharmaceutical composition |
| 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 |
-
2005
- 2005-12-12 CN CN 200510048175 patent/CN1813681A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103239414A (en) * | 2012-02-09 | 2013-08-14 | 陕西博森生物制药股份集团有限公司 | Vitamin C freeze-dried powder for injection and preparation method thereof |
| CN103920154A (en) * | 2014-04-11 | 2014-07-16 | 成都苑东药业有限公司 | Tetracaine hydrochloride pharmaceutical composition for injection and preparation method of pharmaceutical composition |
| CN103920154B (en) * | 2014-04-11 | 2015-07-15 | 成都苑东药业有限公司 | Tetracaine hydrochloride pharmaceutical composition for injection and preparation method of pharmaceutical composition |
| 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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Open date: 20060809 |