CN101422429A - Water-soluble vitamin for injection and preparation method thereof - Google Patents
Water-soluble vitamin for injection and preparation method thereof Download PDFInfo
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- CN101422429A CN101422429A CNA2008101626981A CN200810162698A CN101422429A CN 101422429 A CN101422429 A CN 101422429A CN A2008101626981 A CNA2008101626981 A CN A2008101626981A CN 200810162698 A CN200810162698 A CN 200810162698A CN 101422429 A CN101422429 A CN 101422429A
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- cyclodextrin
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Abstract
The invention provides a water-soluble vitamin used for injection. The water-soluble vitamin used for injection consists of a plurality of vitamins, Beta-cyclodextrin or hydroxypropyl-Beta-cyclodextrin and mannite; wherein, the dosage of the Beta-cyclodextrin or the hydroxypropyl-Beta-cyclodextrin in every 1000 bottles is 15 to 30g; the dosage of the mannite is 20 to 60g. In the invention, the Beta-cyclodextrin or the hydroxypropyl-Beta-cyclodextrin is mainly used for including the water-soluble vitamin and then the mannite is added for freezing the hydroxypropyl-Beta-cyclodextrin to prepare the water-soluble vitamin used for injection. The water-soluble vitamin used for injection and prepared by the invention has higher stability, is hard to be oxidized, is beneficial to storing a product for a long period, is hard to be decomposed under light, is stored under normal temperature, increases the storage convenience and saves other expenses. Simultaneously, the appearance is excellent; the surface is flat, fine and even; the water-soluble vitamin used for injection is not cracked and damaged, does not stick a bottle, is a yellow loose block and has the advantages of excellent redissolution, easy dissolving, clear liquor and high safety.
Description
Technical field
The invention belongs to pharmaceutical preparation, relate to a kind of injection preparation, relate in particular to a kind of novel Vitamin H and preparation method thereof.
Background technology
Water soluble vitamins comprises vitamin C and B family, and wherein vitamin C has another name called ascorbic acid, is a kind of many hydroxy compounds, and is very easily oxidized; And vitamin B complex mainly comprises thiamine mononitrate, riboflavin sodium phosphate, nicotiamide, vitamin B6, sodium dextropantothenate, folic acid, biotin, vitamin B12 etc., and is all soluble in water.According to the literature, Vitamin H is placed for a long time because composition is more, and the easy oxidation of part composition produces insoluble visible foreign matters and impurity, influences drug quality, lessens the curative effect.Lyophilized preparation is also unstable in aqueous solutions such as infusion solutions, influences product quality and curative effect.
Because conventional Vitamin H less stable, thereby need shading, tight envelope, preserve at low temperatures, with the assurance product quality, and with the preservation time lengthening, impurity can increase in the conventional Vitamin H, thereby obviously influenced product quality, reduced the safety and the reliability of medicine.
The raw material of cyclodextrin inclusion is a cyclodextrin, is starch is used by isolating basophilia bacillus cereus in scholar's earth, cultivates the alkali starch enzyme hydrolysis obtain and gets.Common have α, β, three kinds of cyclodextrin of γ, is made of 6,7,8 glucose molecules respectively.Cyclodextrin is the novel material that comprises of present food and medicine.The dissolubility that cyclodextrin is full of thing and can increases medicine maybe can increase stability of drug; Make volatile liquid, solid or oily liquids powdered; Reduce the zest and the toxic and side effects of medicine; Cover bitterness and improve drug bioavailability etc.At present medicinally go up α, beta cyclodextrin is comparatively commonly used, from increasing the dense degree of separating of medicine, α cyclodextrin material is excellent, packet content then beta cyclodextrin wants much superior.
Summary of the invention
The object of the present invention is to provide a kind of Vitamin H, its conventional Vitamin H stability has significantly raising with safety.Vitamin H provided by the present invention consists of: component is in the multivitamin, per 1000 bottles (full dose 1000ml): thiamine mononitrate (vitamin B1) 3.1g, riboflavin sodium phosphate (vitamin B2) 4.9g, nicotiamide 40g, pyridoxine hydrochloride (vitamin B6) 4.9g, sodium pantothenate 16.5g, sodium ascorbate 113g, biotin 0.6mg, folic acid 0.4g, vitamin B12 5.0mg, glycine 300g, Calcium Disodium Versenate 0.5g, methyl parahydroxybenzoate 0.5g; In 1000 bottles, beta-schardinger dextrin-or HP-consumption are 15～30g simultaneously, and the consumption of mannitol is 20～60g, and water for injection adds to full dose 1000ml.Preferred HP-consumption is 20g, and the consumption of mannitol is 40g.
Another object of the present invention provides the preparation method of described Vitamin H, realizes by following steps:
(1) with multivitamin all the components and beta-schardinger dextrin-or HP-dissolving, add the mannitol dissolving again, with citric acid-sodium hydrogen phosphate buffer (pH4.0) adjust pH to 4.0-6.0, the benefit 1000ml that adds to the full amount of water for injection, the pin that adds cumulative volume 0.05～0.1% (g/ml) is used charcoal stirring and adsorbing 20 minutes, filters decarburization;
(2) carry out the inspection of semifinished product behind the microporous filter membrane fine straining with 0.22 μ m, fill, carry out lyophilizing after pressing half plug, freeze drying box is cooled to-40 ℃～-50 ℃ earlier, put into sample then, make its quick freezing, time is 100 minutes～150 minutes, and sublimation temperature is-40 ℃～-10 ℃, and the time is 15～25 hours, baking temperature is-10 ℃～30 ℃, and the time is 10～25 hours.
The present invention mainly with beta-schardinger dextrin-or HP-carry out with behind the water soluble vitamins enclose more in addition the mannitol lyophilizing prepare Vitamin H.
Because ring structure combined with ester dissolubility structures such as the interior vitamin C of water soluble vitamins, vitamin Bs in beta-schardinger dextrin-or HP-were fat-soluble, had formed the clathrate of the relative inertness with non-oxidizability.And after lyophilizing, this kind state is kept, thereby makes Vitamin H of the present invention than the prepared Vitamin H of conventional method higher stability be arranged, be difficult for oxidation, help the product Long-term Storage, see that light is difficult for decomposing, the while good appearance, surfacing, fine and smooth homogeneous, not dry and cracked, not damaged, not sticking bottle, be xanchromatic loose block, and redissolve well, very easily dissolving, the solution clarification, safe.
It has good stability the injection vitamin of the present invention's preparation, and long-term preservation impurity changes advantages such as little, and its need are preserved at normal temperatures simultaneously, have increased the convenience of preservation and have saved other expense.
The specific embodiment
The present invention is further described in conjunction with the embodiments.
Embodiment 1
Each composition of multivitamin is in 1000 bottles:
Thiamine mononitrate (vitamin B1) 3.1g, riboflavin sodium phosphate (vitamin B2) 4.9g, nicotiamide 40g, pyridoxine hydrochloride (vitamin B6) 4.9g, sodium pantothenate 16.5g, sodium ascorbate 113g, biotin 60mg, folic acid 0.4g, vitamin B12 5.0mg, glycine 300g, Calcium Disodium Versenate 0.5g, methyl parahydroxybenzoate 0.5g).
Preparation is formed: multivitamin 483.865g
Beta-schardinger dextrin-15g
Mannitol 20g
Water for injection adds to total amount 1000ml
Preparation method:
1, takes by weighing multivitamin and beta-schardinger dextrin-, the water for injection of adding 80% stirs and makes its dissolving, add mannitol then, stir dissolving fully, with citric acid-sodium hydrogen phosphate buffer (pH4.0) adjust pH 4.0～6.0, benefit adds to the full amount of water for injection, and the pin that adds cumulative volume 0.05～0.1% (g/ml) is used charcoal stirring and adsorbing 20 minutes, filters decarburization.
2, with the microporous filter membrane fine straining of 0.22 μ m.
3, the inspection of semifinished product
4, half plug is pressed in fill.
5, lyophilizing: freeze drying box is cooled to-40 ℃～-50 ℃ earlier, puts into sample then, make its quick freezing, time is 100 minutes～150 minutes, and sublimation temperature is-40 ℃～-10 ℃, and the time is 15～25 hours, baking temperature is-10 ℃～30 ℃, and the time is 10～20 hours.
Embodiment 2
Multivitamin composition and group component be with embodiment 1 in 1000 bottles,
Preparation is formed:
Multivitamin 483.865g
Beta-schardinger dextrin-25g
Mannitol 40g
Water for injection adds to total amount 1000ml
Preparation method:
1, takes by weighing the multivitamin and the beta-schardinger dextrin-of recipe quantity, the water for injection of adding 80% stirs and makes its dissolving, the mannitol that adds recipe quantity then, stir dissolving fully, with citric acid-sodium hydrogen phosphate buffer (pH4.0) adjust pH 4.0～6.0, benefit adds to the full amount of water for injection, and the pin that adds cumulative volume 0.05～0.1% (g/ml) is used charcoal stirring and adsorbing 20 minutes, filters decarburization.
2, with the microporous filter membrane fine straining of 0.22 μ m.
3, the inspection of semifinished product
4, half plug is pressed in fill.
5, lyophilizing: freeze drying box is cooled to-40 ℃～-50 ℃ earlier, puts into sample then, make its quick freezing, time is 100 minutes～150 minutes, and sublimation temperature is-40 ℃～-10 ℃, and the time is 10～20 hours, baking temperature is-10 ℃～30 ℃, and the time is 15～25 hours.
Embodiment 3
Multivitamin composition and group component be with embodiment 1 in 1000 bottles,
Preparation is formed:
Multivitamin 483.865g
HP-30g
Mannitol 60g
Water for injection adds to total amount 1000ml
Preparation method:
1, takes by weighing the multivitamin and the HP-of recipe quantity, the water for injection of adding 80% stirs and makes its dissolving, the mannitol that adds recipe quantity then, stir dissolving fully, with citric acid-sodium hydrogen phosphate buffer (pH4.0) adjust pH 4.0～6.0, benefit adds to the full amount of water for injection, and the pin that adds cumulative volume 0.05～0.1% (g/ml) is used charcoal stirring and adsorbing 20 minutes, filters decarburization.
2, with the microporous filter membrane fine straining of 0.22 μ m.
3, the inspection of semifinished product
4, half plug is pressed in fill.
5, lyophilizing: freeze drying box is cooled to-40 ℃～-50 ℃ earlier, puts into sample then, make its quick freezing, time is 100 minutes～150 minutes, and sublimation temperature is-40 ℃～-10 ℃, and the time is 15～25 hours, baking temperature is-10 ℃～30 ℃, and the time is 20～25 hours.
Embodiment 4
Multivitamin composition and group component be with embodiment 1 in 1000 bottles,
Preparation is formed:
Multivitamin 483.865g
HP-20g
Mannitol 40g
Water for injection adds to total amount 1000ml
Preparation method:
1, takes by weighing the multivitamin and the HP-of recipe quantity, the water for injection of adding 80% stirs and makes its dissolving, the mannitol that adds recipe quantity then, stir dissolving fully, with citric acid-sodium hydrogen phosphate buffer (pH4.0) adjust pH 4.0～6.0, benefit adds to the full amount of water for injection, and the pin that adds cumulative volume 0.05～0.1% (g/ml) is used charcoal stirring and adsorbing 20 minutes, filters decarburization.
2, with the microporous filter membrane fine straining of 0.22 μ m.
3, the inspection of semifinished product
4, half plug is pressed in fill.
5, lyophilizing: freeze drying box is cooled to-40 ℃～-50 ℃ earlier, puts into sample then, make its quick freezing, time is 100 minutes～150 minutes, and sublimation temperature is-40 ℃～-10 ℃, and the time is 10～15 hours, baking temperature is-10 ℃～30 ℃, and the time is 25～30 hours.
Embodiment 5:
With the Vitamin H of embodiment 4 prepared Vitamin Hs and conventional method preparation (available from Chongqing medicine friend pharmaceutical Co. Ltd, lot number 20070206) stable contrast test, with character color and luster, content serves as to investigate index, carry out 12 months by a definite date observation and mensuration, the results are shown in Table 1.
Table 1
The Vitamin H of getting the preparation of embodiment 4 prepared Vitamin Hs and conventional method is (available from Chongqing medicine friend pharmaceutical Co. Ltd, lot number 20070206), under identical bar method part, be prepared into injection solution, investigate the color and luster and the changes of contents of two groups of solution respectively at 15min, 30min, 45min, 60min, the results are shown in Table 2.The result shows that the sample solution color and luster of the present invention's preparation does not have significant change, and the changes of contents amplitude is also less.
Table 2
Choose the prepared Vitamin H of above embodiment 1-4, and under 60 ℃ of high temperature, illumination 4500Lx condition, place respectively with the Vitamin H of conventional method preparation (available from Chongqing medicine friend pharmaceutical Co. Ltd, lot number 20070206) and to carry out the influence factor in 10 days and test investigation; Under 40 ℃ of high temperature, relative humidity 75% ± 5% condition 6 months, carry out accelerated test and investigate; Under 25 ℃ of high temperature, relative humidity 60% ± 10% condition 18 months, carry out long term test and investigate, detect the variation of every quality index, data result sees Table 3, table 4, table 5.
Table 3 influence factor result
Table 4 accelerated test result
Table 5 long-term test results
Conclusion: by above data result as can be seen, Zhi Bei Vitamin H according to a conventional method, pH value and changes of contents are very big in quality research is investigated, less stable; And by the sample effects factor 10 days of the Vitamin H of the present invention preparation, quicken June and long-term 18 months after every quality index do not have significant change, stability is fine.
Claims (4)
1. Vitamin H, it is characterized in that this Vitamin H consists of: multivitamin, beta-schardinger dextrin-or HP-, mannitol, water for injection, the multivitamin component is among every 1000ml: thiamine mononitrate 3.1g, riboflavin sodium phosphate 4.9g, nicotiamide 40g, pyridoxine hydrochloride 4.9g, sodium pantothenate 16.5g, sodium ascorbate 113g, biotin 0.6mg, folic acid 0.4g, vitamin B12 5.0mg, glycine 300g, Calcium Disodium Versenate 0.5g, methyl parahydroxybenzoate 0.5g; Beta-schardinger dextrin-or HP-consumption are 15～30g, and the mannitol consumption is 20～60g, and water for injection adds to full dose.
2. Vitamin H according to claim 1 is characterized in that: in 1000 bottles, the HP-consumption is 20g among every 1000ml, and the consumption of mannitol is 40g.
3. the preparation method of Vitamin H according to claim 1 and 2 is characterized in that realizing by following steps:
(1) with multivitamin all the components and beta-schardinger dextrin-or HP-dissolving, add the mannitol stirring and dissolving again, with citric acid-sodium hydrogen phosphate buffer adjust pH to 4.0-6.0, the benefit 1000ml that adds to the full amount of water for injection, the pin that adds cumulative volume 0.05～0.1% (g/ml) is used charcoal stirring and adsorbing 20 minutes, filters decarburization;
(2) carry out the inspection of semifinished product behind the microporous filter membrane fine straining with 0.22 μ m, half plug is pressed in fill;
(3) freeze drying box is cooled to-40 ℃～-50 ℃, puts into sample then, make its quick freezing, the time is 100 minutes～150 minutes, and sublimation temperature is-40 ℃～-10 ℃, and the time is 15～25 hours, and baking temperature is-10 ℃～30 ℃, and the time is 10～25 hours.
4. the preparation method of Vitamin H according to claim 3, it is characterized in that: described step (1) is with multivitamin all the components and HP-, the water for injection of adding 80% stirs and makes its dissolving, and then adding mannitol dissolving, with citric acid-sodium hydrogen phosphate buffer adjust pH to 4.0-6.0, benefit adds to the full amount of water for injection, and the pin that adds cumulative volume 0.05～0.1% (g/ml) is used charcoal stirring and adsorbing 20 minutes, filters decarburization.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101626981A CN101422429A (en) | 2008-11-28 | 2008-11-28 | Water-soluble vitamin for injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101626981A CN101422429A (en) | 2008-11-28 | 2008-11-28 | Water-soluble vitamin for injection and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101780100A (en) * | 2010-02-10 | 2010-07-21 | 北京国仁堂医药科技发展有限公司 | Water-soluble vitamin composition for injection and preparation method thereof |
| CN104382865A (en) * | 2014-10-29 | 2015-03-04 | 武汉汇海医药有限公司 | Water-soluble vitamin pharmaceutical composition for injection |
| CN104546465A (en) * | 2013-10-21 | 2015-04-29 | 河南辅仁怀庆堂制药有限公司 | New process of freeze-drying procedure of riboflavin sodium phosphate for injection |
-
2008
- 2008-11-28 CN CNA2008101626981A patent/CN101422429A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101780100A (en) * | 2010-02-10 | 2010-07-21 | 北京国仁堂医药科技发展有限公司 | Water-soluble vitamin composition for injection and preparation method thereof |
| CN101780100B (en) * | 2010-02-10 | 2011-12-21 | 北京国仁堂医药科技发展有限公司 | Water-soluble vitamin composition for injection and preparation method thereof |
| CN104546465A (en) * | 2013-10-21 | 2015-04-29 | 河南辅仁怀庆堂制药有限公司 | New process of freeze-drying procedure of riboflavin sodium phosphate for injection |
| CN104382865A (en) * | 2014-10-29 | 2015-03-04 | 武汉汇海医药有限公司 | Water-soluble vitamin pharmaceutical composition for injection |
| CN104382865B (en) * | 2014-10-29 | 2017-01-11 | 武汉汇海医药有限公司 | Water-soluble vitamin pharmaceutical composition for injection |
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Open date: 20090506 |